National Legal News
IN THE HEADLINES:
Counterfeit drugs may be on the rise in US
February 17, 2012
The AP (2/16, Johnson) reports, "The discovery that a fake version of the widely used cancer medicine Avastin [bevacizumab] is circulating in the United States is raising new fears that the multibillion-dollar drug-counterfeiting trade is increasingly making inroads in the US" According to the AP, "the criminal practice has largely been relegated to poor countries with lax regulations" but "with more" drugs "in the US being manufactured overseas, American authorities are afraid more counterfeits will find their way into this country, putting patients' lives at risk." The fake bevacizumab "discovery follows other recent instances in the US of counterfeiting, involving such drugs as Viagra [sildenafil citrate], the cholesterol medicine Lipitor [atorvastatin] and the weight-loss" medication "Alli [orlistat]."
The Wall Street Journal (2/16, B1, Rockoff, Whalen, Weaver, Subscription Publication) reports injectable medications are increasingly become popular with counterfeiters because they command greater prices than regular drugs. Although the number of reports of fake injectable drugs is small, counterfeiting of these drugs has more than doubled to 4% during a four year span, according to the Pharmaceutical Security Institute. Because these injectable drugs are most often used for life threatening diseases such as cancer, many healthcare professionals are concerned.
Reported by the American Association for Justice
Study: New York hospitals violate rules about pursuing unpaid bills
February 15, 2012
In a front-page story, the New York Times (2/13, A1, Bernstein, Subscription Publication) reports that New York has "passed laws curbing hospitals' pursuit of unpaid bills," but "a new study of New York hospitals' practices and state records finds that most medical centers are violating the rules without consequences, even as the state government ignores glaring problems in the hospitals' own reports." The study, by the Community Service Society of New York, "found that some hospitals did not provide financial aid applications at all, and that many made impermissible demands for irrelevant documents or failed to supply key information, like eligibility rules for big discounts required by state law in 2007." New York "state's Department of Health acknowledges systemic problems, including the need for better reporting and enforcement, a spokesman, Michael Moran, said."
Reported by the American Association for Justice
Obama announces $26 billion foreclosure settlement
February 13, 2012
The foreclosure settlement announced led all three network news broadcasts last night, receiving an extraordinary amount of coverage -- nearly 15 minutes in total. Due to the complexity of the settlement itself, coverage last night and this morning focused more on its details than political or economic implications. Broadly speaking, however, the deal is being described as ambitious in scope and intent, but unlikely to restore the housing market in the near future. The President's remarks yesterday, as well as those from Administration officials, garner relatively little notice in this morning's print coverage.
Notably, NBC Nightly News (2/9, lead story), with the largest audience of any news program, focused on the perceived shortcoming of the deal, noting that "consumer groups and many experts say the banks got off easy." The AP (2/10, Kravitz) also says that although the settlement was "hailed by" the Administration, "consumer advocates countered that far too few people will benefit." According to the AP, "The deal will reduce loans for only a fraction of those Americans who owe more than their homes are worth," and the "checks" for those "who were improperly foreclosed upon...are modest. It's unclear how much the deal will help struggling homeowners keep their homes or benefit those who have already lost theirs." Similarly, USA Today (2/10, Schmit, Davidson) reports that the settlement "gives little immediate relief to the majority of US homeowners who are current on their home payments, and even less relief for homeowners who'll likely never end up with a distressed loan."
Brian Williams, at the opening of NBC Nightly News (2/9, lead story), said, "Aside from the enormous damage the foreclosure mess caused, a big complaint across this country continues to be nobody paid for it. Well, today the President announced a settlement between the Feds, state attorneys general and the nation's five largest banks to help distressed borrowers and struggling homeowners. The problem? Well, like so many other government plans, it's the details." NBC went on to report that "consumer groups and many experts say the banks got off easy. ... The five banks together earned more than $46 billion in profits last year, yet under the settlement, they have to pony up only five billion in hard cash." Susan Webber of Naked Capitalism: "The banks come out the big winners because the costs they are paying are very small in terms of the damages that were done."
McClatchy (2/10, Ordonez, Hall) says "the settlement effectively punishes the banks for alleged abuses in the foreclosure process, including robo-signing. ... About 1 million households at risk of foreclosure should be able to reduce their loans. Another 750,000 Americans who lost their homes to foreclosures will receive about $2,000 each." Nevertheless, McClatchy adds that "housing experts doubted...that the settlement the president described as a 'landmark' will have a broader impact on the struggling housing sector."
According to the Washington Post (2/10, Dennis, Horwitz), "The deal aims to help troubled borrowers by reducing the amount they owe on their mortgages, lowering their interest rates and paying restitution to homeowners who suffered mortgage-related abuses. It will force lenders to revamp how they interact with troubled homeowners and bar them from trying to foreclose on borrowers while simultaneously negotiating mortgage modifications. In addition, firms will have to make sure borrowers have a single point of contact with a lender, rather than being shuttled to different employees with each interaction."
Settlement does not preclude criminal charges or lawsuits. The Los Angeles Times (2/10, Popper, Reckard) reports the banks "previously made changes to improve the way they foreclose on homeowners," and, "until recently, analysts thought this might put to rest many of the largest complaints about the role the banks played in the financial crisis," but "it hasn't. There are a growing number of signals that prosecutors and regulators are stepping up efforts to bring new lawsuits and criminal charges in connection with the crisis. ... Authorities can still investigate various fraud claims, including those involving the mortgage bonds whose meltdown triggered a global financial crisis," an "what's more, there is no criminal immunity."
Reported by the American Association for Justice
FDA now says two lipsticks sold in US may have high levels of lead
February 8, 2012
The Forbes (2/8, Westervelt) reports, "In 2007, largely in response to a report released by the Campaign for Safe Cosmetics, the FDA began testing various lipsticks sold in the United States," with "FDA scientists" concluding "that none of them contained unsafe levels of lead." However, about two months ago, the agency "updated its tests and posted the results on its website rather quietly," now saying that lead levels in "two brands (Maybelline and L'Oreal) with lipsticks above California's standard" of 5 parts-per-million.
Reported by the American Association for Justice
Company recalls eggs over listeria contamination
February 6, 2012
In continuing coverage, the AP (2/6) reports that Michael Foods, based in Minnesota, "said Friday it is recalling more than a million hard-cooked eggs distributed to 34 states after testing revealed some may be contaminated with listeria. ... The US Food and Drug Administration said the eggs were produced at the company's plant in Wakefield, Neb., and were bought by food distributors and manufacturers and not sold directly to retailers. There have been no reports of illness connected to the eggs, the agency said."
Reported by the American Association for Justice
Drug shortages force patients to miss chemotherapy, switch to other medications
February 6, 2012
The Shreveport Times (LA) (2/4, Tyrrell) reports, "With 230 drugs reported in short supply this past year, cancer patients have been forced to miss chemotherapy treatments and switch to other medicines with more side effects." Legislation recently unveiled by Rep. John Carney (D-DE) seeks to keep the "drug shortage problem from getting worse." The Times adds, "Dr. Stephen Grubbs, an oncologist at Christiana Care's Helen F. Graham Cancer Center, said when he checked" an FDA list of drug shortages "Tuesday, '95 percent' of the 50 sterile injectible drugs on it were generic." Dr. Grubbs said, "Anything we can do to alleviate this problem will be best for patients."
Reported by the American Association for Justice
House report indicates tanning-salon business "built on deception"
February 06. 2012
ABC World News (2/1, story 8, 2:25, Sawyer) reported, "There are more tanning salons in America than there are Starbucks. It is a huge, booming business. But some members of Congress warned today that it is also built on massive deception." ABC News correspondent Jim Avila explained that "nearly two years ago, the FDA's own experts, along with pediatricians and dermatologists, recommended a ban on indoor tanning for minors. But the tanning lobbyists have spent nearly $500,000 since, defending the industry's health claims. And, so far, no FDA action," despite the fact that "there is no safe indoor tan."
The National Journal (2/2, Sanger-Katz, Subscription Publication) reports, "A secret-shopper study by House Democratic staffers found that tanning-salon employees routinely lied about the risks of indoor tanning, and frequently provided misleading information suggesting that tanning had health benefits." The investigative report, "commissioned by the Energy and Commerce Committee minority staff, involved interviews with 300 salons around the country." The study found that "salons routinely gave inaccurate information," with some 90% saying that tanning posed no risks to health.
The "On Deadline" blog of USA Today (2/2, Bacon) notes that the staff study cites American Academy of Pediatrics warning that indoor tanning beds are "generally unsafe for children," recommending they be banned for kids under 18. On its website, CBS News (2/2, Cordes) points out that the "risk of melanoma goes up 75 percent when tanning bed use begins before the age of 30."
Reported by the American Association for Justice
GlaxoSmithKline agrees to settle 20,000 suits over Avandia
February 6, 2012
Bloomberg News (2/2, Feeley) reports, "GlaxoSmithKline Plc which is paying $3 billion to resolve government claims that it illegally marketed drugs such as the Avandia diabetes medication, agreed to settle more lawsuits over the pills, a lawyer said." Bloomberg adds, "Glaxo, the UK's biggest drugmaker, agreed last month to resolve more than 20,000 cases alleging Avandia causes heart attacks, said Paul Kiesel, a lawyer for former users. The accord, reached in court-ordered mediation, included a case that was set for trial in state court in Los Angeles, he said."
Reported by the American Association for Justice
New websites streamline data on drugs, medical devices
January 31, 2012
In her Wall Street Journal (1/31, Subscription Publication) column, Melinda Beck writes, the US Food and Drug Administration has an abundance of information on "adverse event" reports for many prescription medications but that information was not easily accessible until recently. One start up company called AdverseEvents Inc has gathered information from the FDA's database so an individual can search its website for adverse event reports for some 4,500 medications. A second start up, called Clarimed LLC, also compiled data from the FDA, but its database is on 130,000 medical devices. Both companies launched their online websites back in September to help empower patients.
Reported by the American Association for Justice
Experts predict extinction of health insurance companies
January 31, 2012
Former Obama Administration advisors Ezekiel J. Emanuel and Jeffrey B. Liebman predict in a piece for the New York Times (1/31) Opinionator that "by 2020, the American health insurance industry will be extinct. Insurance companies will be replaced by accountable care organizations -- groups of doctors, hospitals and other health care providers who come together to provide the full range of medical care for patients." The writers argue that "accountable care organizations will...shift the focus of medicine away from treating sickness and toward keeping people healthy." They also note that some "health insurers see this asteroid coming" and are buying or developing services to become involved "in the new world of coordinated care."
Reported by the American Association for Justice
Drug shortage puts pharma companies on "hot seat"
January 30, 2012
The St. Paul Pioneer-Press (1/39, Snowbeck) reported, "Drug shortages are putting pharmaceutical companies on the hot seat. Last week, medical-products giant Johnson & Johnson assured shareholders that it is doing everything possible to resolve a shortage of a chemotherapy drug called Doxil [liposomal doxorubicin], which is used by patients with ovarian and other sorts of cancer." Though the company said the liposomal doxorubicin shortage probably won't be resolved until much later this year. One "survey conducted by the American Society of Health System Pharmacists" found "that hospital pharmacists are spending 8 to 12 additional hours per week dealing with shortages, work that costs the health care system about $216 million a year."
Patients unable to fill prescriptions due to shortages. The Duluth (MN) News Tribune (1/28, Lundy) reported, "The shortage of Adderall [dextroamphetamine/amphetamine], Ritalin [methylphenidate] and similar drugs has been playing out nationwide for months. It peaked in the fall after first surfacing in May, said Erin Fox, manager of the University of Utah's Drug Information Service, which tracks drug availability nationwide for the Food and Drug Administration." What's more, the shortage "has been more acute for Adderall, which is a composite of three kinds of amphetamine salts, because it has fewer manufacturers than Ritalin." The Tribune adds, "Sen. Amy Klobuchar, D-Minn., who is author of legislation to address drug shortages, said the number of drugs with shortages rose from 55 in 2005 to 231 last year."
Reported by the American Association for Justice
Editor says tort-reform law hasn't benefitted Texas
January 26, 2012
The managing editor of the Henderson (TX) Daily News (1/23, Floyd) wrote in commentary, "Texas may not have been the first state to welcome tort reforms but I can't imagine anyone embracing it with such wild enthusiasm as Texans over the past 20 years or so." He adds that in his failed presidential campaign, Gov. Rick Perry "perpetuated the myth that implementing Texas-style tort reforms would go a long way toward curing what's wrong with the healthcare system." Noting that malpractice insurance premiums dropped after the state enacted curbs on non-economic damages awards, the author notes that the state's post-enactment doctor-population ratio fell to nearly the bottom of the states. In fact, he says, Texans "would be hard pressed to claim any direct benefit -- except, that is, for Texans who are doctors. Medical liability premiums have declined by nearly 30 percent since tort reforms were enacted."
Reported by the American Association for Justice
Five biggest US banks agree to $25 billion foreclosure settlement
January 26, 2012
The CBS Evening News (1/23, story 2, 1:50, Pelley) reported, "The nation's five largest banks have agreed to a settlement that may end one of the most painful chapters in the collapse of the housing market. Eight million American homeowners have gone through foreclosure -- some of them were hauled into banks that cut corners and used fraudulent documents. Under the terms of this proposal a million Americans may get help to stay in their homes." CBS added, "Major mortgage lenders would agree to pay $25 billion, money that would be used to reduce principal for roughly a million troubled borrowers; 750,000 would also receive checks for $1,800."
Liberal groups unhappy with proposed settlement. The Washington Post (1/24, Dennis) reports, "Liberal activists and consumer advocates [were] insisting that the president is settling too soon, for too little. Those complaints surfaced again Monday as US Department of Housing and Urban Development Secretary Shaun Donovan, top Justice Department official Tom Perrelli and Iowa Attorney General Tom Miller gathered in Chicago to brief Democratic state attorneys general on the outlines of the agreement and to shore up support."
The Hill (1/24, Needham) reports in its "On The Money" blog, "Sen. Sherrod Brown (D-Ohio) and Rep. Brad Miller (D-N.C.) along with several other advocates on Monday said a proposed settlement of upward of $25 billion between federal and state governments and the nation's five largest banks is wholly inadequate and ambiguous as to which homeowners it will help. Meanwhile, Maryland Democrat Elijah Cummings, ranking member of the House Oversight and Government Reform Committee, sent a letter to Chairman Darrell Issa (R-Calif.) asking him to bring high-ranking executives from the nation's biggest mortgage banks to Capitol Hill testify about foreclosure abuses."
The Wall Street Journal (1/24, Simon, Nicas, Timiraos, Subscription Publication) reports that the proposed deal is the result of nearly a year of discussions between federal and state officials and Ally Financial Inc., Bank of America Corp., Citigroup Inc., J.P. Morgan Chase & Co. and Wells Fargo & Co.
Reported by the American Association for Justice
Witness: J&J hid studies showing users of Risperidone developed diabetes
January 19, 2012
Bloomberg News (1/19, Feeley, Cronin Fisk, Voreacos) reports, "Johnson & Johnson officials hid three studies showing some users of its Risperdal [risperidone] antipsychotic drug developed diabetes while claiming the medicine didn't cause the disease, a witness testified." Joseph Glenmullen, a psychiatrist and Harvard Medical School instructor, told a Texas jury, "As early as 1999, Johnson & Johnson's Janssen unit had researchers' findings that about half the patients taking Risperdal in a study comparing its risks to those of Eli Lilly & Co.'s Zyprexa [olanzapine] antipsychotic drug developed diabetes after a year on the medication." Glenmullen added, "At the same time, Janssen salespeople were telling doctors researchers concluded the drug didn't cause the disease."
Witness says J&J's marketing may have violated agreement. Bloomberg News (1/19, Feeley, Cronin Fisk, Voreacos) reports, "A Johnson & Johnson unit's marketing of its Risperdal antipsychotic drug to doctors treating mentally ill children may have violated the drugmaker's agreement with Texas, a state official testified." Billy Milwee, the state Medicaid director, explained to a jury today that "a push by J&J's Janssen unit to increase Risperdal prescriptions for children and adolescents before 2006 may have broken the drugmaker's promises to 'comply with all state and federal laws' in exchange for having the drug covered by the Texas Medicaid program." Bloomberg News points out that "the US Food and Drug Administration didn't approve Risperdal for any pediatric use until 2006."
Reported by the American Association for Justice
Witness tells jurors J&J marketed Risperidone for children despite FDA warnings January 18, 2012
In continuing coverage, Bloomberg News (1/14, Voreacos, Fisk, Feeley) reported, "The antipsychotic drug Risperdal was marketed for children and adolescents by Johnson & Johnson's Janssen unit after warnings by the US Food and Drug Administration not to do so, a witness told jurors." Arnold Friede, an expert witness for the state, "explained company documents and FDA letters as lawyers for Texas seek to show Janssen repeatedly disregarded agency admonitions to not market Risperdal beyond its initial approved use for psychotic disorders including schizophrenia." The company's "marketing to children began after the drug's introduction in 1994 and continued until the FDA's first approval for pediatric uses in 2006," Friede stated. The case is Texas v. Janssen LP, D-1GV-04-001288, District Court, Travis County, Texas (Austin).
Reported by the American Association for Justice
J&J trial hears from former Texas official paid to promote anti- psychotic drug
January 16, 2012
In continuing coverage, Pharmalot (1/12, Silverman) reports on the whistleblower trial in Austin of whether Johnson & Johnson's Texas Medication Algorithm Project defrauded Texas by boosting use of its Risperdal antipsychotic. A former Pennsylvania state investigator originally filed the suit in 2004; Texas joined it in 2006. The trial earlier this week saw videotaped testimony from Steve Shon, a former medical director of behavioral health at the Department of State Health Services, who "was paid to speak to officials in other states about TMAP guidelines that J&J purportedly hoped would be used as a protocol for prescribing antipsychotic drugs, notably Risperdal." The Texas attorney general "is arguing the payments to Shon -- which totaled nearly $48,000 over several years -- were part of a plan to influence guidelines."
Bloomberg News (1/13, Voreacos, Fisk, Feeley) adds that in the third day of the trial, whistleblower Allen Jones testified that "he was an investigator in the Pennsylvania Office of Inspector General in 2002 when he looked into an unregistered bank account" of a state pharmacist on a Pennsylvania committee that advised whether the state should use newer, more expensive drugs like Risperdal in state-funded treatment of mental-health patients. Jones said that he discovered the account "was used to deposit money from drug companies." Texas claims that its Medicaid program overpaid at least $579 million for Risperdal.
Reported by the American Association for Justice
FDA: J&J continued to sell insulin pumps after discovering defects
January 11, 2012
Bloomberg News (1/11, Nussbaum) reports on word from the FDA that "Johnson & Johnson's Animas unit kept selling insulin pumps last year after learning of malfunctions with the devices that prompted it to make design changes." The problems "with Animas' One Touch Ping and 2020 pumps prompted a company investigation that started in April, according to" an FDA "letter, which was dated Dec. 27." The December "warning could lead to fines or affect J&J's chances of winning federal contracts, the agency said in the letter."
Reported by the American Association for Justice
FDA issues order for surgical mesh makers to study product's risks
January 6, 2012
The New York Times (1/5, B4, Meier, Subscription Publication) reports, "The Food and Drug Administration issued an order on Wednesday requiring makers of implantable surgical mesh used to treat urinary incontinence in women to study its risks." This "move comes after years of reports of serious injuries linked to the devices, including infections, pain and other complications." In addition, "it follows a recommendation in September by an FDA advisory panel that the agency require such studies."
"The FDA said in an online post that 33 manufacturers of medical mesh would be required to submit follow-up safety studies to the agency," the AP (1/5) reports. "Manufacturers include Johnson & Johnson, Boston Scientific Corp. and CR Bard." Currently, the agency "is considering reclassifying the mesh as a high-risk device, so that manufacturers would have to prove the product's safety and effectiveness before it could launch. The reclassification could take years," the AP points out.
According to Bloomberg News (1/5, Nussbaum, Voreacos), "Almost 300,000 synthetic meshes were implanted in US women in 2010 to treat incontinence or shore up pelvic muscles, the agency estimates." To date, "the devices' alleged failures have spurred more than 650 lawsuits against manufacturers and heightened scrutiny of the FDA program that cleared the products for sale without human testing." Now, letters from the FDA "ask each manufacturer to collect data on the results and potential complications of transvaginal procedures, in which the hammock-like meshes are threaded in place through an incision in the vagina."
Reported by the American Association for Justice
Short supply of ADHD medications has patients worried
January 3, 2012
The New York Times (1/1, A1, Harris, Subscription Publication) reported in a front-page story, "Medicines to treat attention deficit hyperactivity disorder are in such short supply that hundreds of patients complain daily to the Food and Drug Administration that they are unable to find a pharmacy with enough pills to fill their prescriptions." The Times said that "the shortages are a result of a troubled partnership between drug manufacturers and the Drug Enforcement Administration, with companies trying to maximize their profits and drug enforcement agents trying to minimize abuse by people."
"Shortages have become so endemic -- particularly of cheaper generics -- that some patients say that they suffer almost constant worry that they will not get enough," the New York Times (12/31, O'Connor) "Well" blog reported. Many "drug manufacturers have announced that their medicines are in short supply" and "the Food and Drug Administration lists the drugs as being in short supply on its official drug shortages list." In addition, "the American Society of Health-System Pharmacists, which tracks drug shortages for hospitals, lists the medicines as being in short supply."
The Boston Globe (1/1, Harris) reported that the "American Academy of Child and Adolescent Psychiatry has told its members that shortages seem to be 'widespread across a number of states" and are 'devastating' for children."
Reported by the American Association for Justice
ADHD medications may not increase cardiovascular risks in adults
January 3, 2012
The Washington Post (1/2, Searing) reported that a study, published online Dec. 12 in the Journal of the American Medical Association, "analyzed data on 443,198 adults, 25 to 64 years old, including 150,359 who took ADHD medications, mainly Ritalin (methylphenidate) or Adderall (amphetamine) but also Strattera (atomoxetine) or Cylert (pemoline)." The researchers found that "in about a two-year period, 1,357 heart attacks, 575 strokes and 296 sudden cardiac deaths were recorded" but "the cardiovascular problems occurred at virtually the same rate among people who took ADHD medications and those who did not, regardless of people's age, how long they had been taking the medication or which drug they took." However, some limitations of the study were that "data came from electronic records of filled prescriptions; consumption of medication was not verified" and "the study did not determine whether dosage made a difference or whether use of the medications contributed to less severe cardiovascular problems."
Reported by the American Association for Justice
Group warns against using "anti-aging" interventions
December 30, 2011
CNN /Health.com (12/28, Voss) reported that recombinant human growth hormone (HGH) is "a synthetic version of a pituitary hormone hawked as a miraculous fountain of youth," even though "the US Food and Drug Administration (FDA) warns that taking HGH poses serious health risks." Use of HGH has been associated with an increased risk for cancer, for example. "Aging is a natural process, not a medical condition, and there isn't any therapy that can reverse it or slow it down," according to S. Jay Olshansky, PhD, of the Center on Aging at the University of Chicago. "Official medical associations from the Endocrine Society to the American Medical Association warn against using 'anti-aging' interventions."
Reported by the American Association for Justice
Seven LCD manufacturers to settle price-fixing lawsuits for $553M
December 28, 2011
The AP (12/27) reported, "Seven companies based in Asia will pay $553 million to settle claims by officials in eight states that they conspired to inflate prices for liquid crystal display screens used in televisions and computer monitors, New York Attorney General Eric Schneiderman said Tuesday." The deal "provides $501 million for partial refunds for consumers in 24 states and the District of Columbia who purchased products with the companies' LCD panels from 1999 through 2006."
Andrea Chang wrote in a Los Angeles Times (12/27) blog posting, "The companies -- Chimei Innolux Corp., Chunghwa Picture Tubes Ltd., Epson Imaging Devices Corp., HannStar Display Corp., Hitachi Displays Ltd., Samsung Electronics Co. and Sharp Corp., and their US affiliates -- agreed to pay more than $538 million to settle antitrust claims brought on behalf of consumers, government entities and other public entities by a group of eight attorneys general and private class-action attorneys, according to the New York attorney general's office." In addition, "five of the tech companies agreed to pay more than $14 million to settle other claims brought by the states in their law enforcement capacities."
Reported by the American Association for Justice
Target recalls 139,000 children's suitcases over high levels of lead
December 23, 2011
The AP (12/22) reported, "Target Corp. and the US Consumer Product Safety Commission on Thursday announced a recall of some children's suitcases because they violate federal lead paint standards." Some "139,000 of the Circo 17-inch suitcases, which were manufactured in China, were sold exclusively at Target stores between April and August for about $21." According to the CPSC, "the suitcase's surface coating contains 'excessive levels' of lead that violate the government's lead paint standard." So far, there have no reports of injuries.
Reported by the American Association for Justice
DoJ announces largest-ever settlement of lending fraud charges with BoA
December 23, 2011
Attorney General Eric Holder's announcement on Wednesday that the Justice Department has settled discrimination charges against the now-defunct mortgage lender Countrywide generated significant print and television coverage, including five minutes of coverage on network newscasts. Nearly all the coverage notes that the settlement, in which Bank of America, which took over Countrywide in 2008, will pay $335 million, is the largest ever of its kind. NBC Nightly News (12/21, story 4, 0:35, Williams) reported, "The Justice Department announced today it has settled lending discrimination charges against the defunct mortgage lender Countrywide which steered black and Hispanic borrowers into subprime loans even when they qualified for prime mortgages. Then they charged higher fees and rates to more than 200,000 minority borrowers."
Reported by the American Association for Justice
FDA renews warning on ShoulderFlex Massager
December 23, 2011
The Boston Globe (12/21, Kotz) reported, "If you own a ShoulderFlex Massager, get rid of it, said the US Food and Drug Administration in a warning issued" on Wednesday. This "device -- which delivers a deep tissue massage to the neck, shoulders, and back while you're lying down -- was recalled last August after it killed one user and resulted in the near-strangulation of another." Nevertheless, the FDA "is concerned that the now bankrupt company, King International, didn't do a good enough job recalling the product before it went out of business."
NPR (12/21, Hensley) noted in its "Shots" health blog that the new alert warns that a recent compliance audit shows that King International went out of business before completing the recall. FDA found that the toll-free number set up for the recall was no longer in service, and that almost 12,000 of the massagers have been distributed in the US since 2003.
MSNBC in its "Vitals" blog (12/21, Dahlstrom) added that a "quick Internet search reveals that the product is still available at several online web sites" and recalls that it was responsible for the strangulation death of Dr. Michelle Ferrari- Gegerson, "a 37-year-old Florida woman, was found dead by her husband last Christmas Eve after her leather necklace got tangled in the device."
Reported by the American Association for Justice
FDA says patients with permanent atrial fibrillation should not use dronedarone
December 20, 2011
The AP (12/19, Perrone) reported, "Federal health officials said Monday they have added new safety warnings to the heart rhythm drug Multaq [dronedarone], after a company study by Sanofi linked the tablet to higher rates of heart attack, stroke and death in a subset of patients." According to the AP, "the boxed warning highlights the results of a study in which Multaq doubled the risk of heart-related complications in patients with permanent atrial fibrillation." The new "label stresses that Multaq is only approved for the short-term form of the condition and a related ailment known as atrial flutter." The Wall Street Journal (12/19, Burton, Subscription Publication) reported that earlier this year, the agency requested that the company add to the medication's label that "liver injury, including acute liver failure requiring transplant, has been reported in patients treated with Multaq."
Reported by the American Association for Justice
FDA requires warning on Boston Scientific stent
December 20, 2011
Reuters (12/16, Sherman) reported that the Food and Drug Administration has approved the Boston Scientific Corp. Promus Element heart stent but is requiring that the company warn doctors about a rare but serious problem. The agency says that the stent, like competing ones made by Medtronic Inc. and Abbott Laboratories may become deformed after implantation. Ashley Boam, director of FDA's division of Interventional Cardiology Devices Branch, says that the "longitudinal stent deformation" may be due to the stents very thin struts, which make the device more flexible and thus implantable in narrow or hard-to-reach blood vessels. The agency has required the company to include a section on the issue on the company's 20-page label, describing the problem and where it most often occurs, and providing guidance and suggesting techniques to minimize problems.
Reported by the American Association for Justice
Insurance industry accused of making huge profits by delaying claims
December 15, 2011
The Huffington Post (12/13, Reilly) reported, "Unlike many other businesses, the insurance industry is bound by law to act in good faith with its customers." Insurance companies were considered "semi- public-trusts." Yet, that changed in the 1990s when their focus shifted from service to profit making. Allstate is credited with originating this trend by adopting a plan crafted by consulting firm McKinsey & Company. The strategy was simple: "Rather than adjusting claims the traditional way, which gave claims managers wide latitude to serve customers, insurers embraced a computer-driven method that produced purposefully low offers to claimants." Customers who accepted "low-ball offers" had their claims processed quickly, while those who refused were forced to wait. "As former Allstate agent Shannon Kmatz told the American Association for Justice, the trial lawyers' lobby, the strategy was to make claims 'so expensive and so time-consuming that lawyers would start refusing to help clients.'"
Reported by the American Association for Justice
FDA accuses 1-800-GET THIN centers of misleading customers
December 14, 2011
The AP (12/13) reported that officials with the Food and Drug Administration "have issued warning letters to eight surgical centers and a marketing firm in California for misleading advertisements promoting the Lap-Band, a stomach-restricting device used to treat obesity." Yesterday, the agency said in a news release "that advertisements by the centers and a marketing firm, 1-800-GET-THIN, do not provide mandatory information about the risks and side effects of Lap-Band implantation. The stomach-restricting band -- made by Irvine, Calif.-based Allergan Inc. -- limits food intake, but can also cause irritation of the esophagus, infection, nausea and vomiting in some cases."
Reported by the American Association for Justice
Risk of broken wheels prompts Ford to recall 129,000 Fusions and Mercury Milans
December 12, 2011
Christopher Jensen wrote in a New York Times (12/9) blog posting that "Ford is recalling almost 129,000 of its 2010-11 Ford Fusions and Mercury Milans because the wheel studs on vehicles equipped with 17-inch steel wheels could break, potentially leading to a wheel coming loose and falling off." The company "told the National Highway Traffic Safety Administration of the recall in a report (PDF) filed Friday on the agency's Web site."
Chris Woodyard wrote in a USA Today (12/9) blog posting that the "recalled vehicles were built April 1 through April 30, 2009, and Dec. 1, 2009 through Nov. 13, 2010." People who own affected vehicles "will be notified the week of Jan. 24. Dealers will inspect the rear brake disc surface and replace the discs at no charge if necessary."
Bloomberg News (12/9, Plungis) quoted Ford spokeswoman Susan Krusel as saying, "Affected customers can continue to drive their vehicles. ... We are not aware of any accidents or injuries." Reuters (12/9) also covered the story.
Reported by the American Association for Justice
FDA, FTC warn companies to stop selling homeopathic diet products
December 8, 2011
The AP (12/6) reported that the Food and Drug Administration issued warning letters to seven companies, ordering them "to stop selling an unproven weight loss remedy that uses protein from the human placenta." The FDA has approved human chorionic gonadotropin (hCG), produced by the placenta and found in the urine of pregnant women, for certain infertility treatments, but says there is no evidence that it is effective for weight reduction. Sold as drops, pellets or sprays, HCG is often marketed as boosting low-calorie dieters' weight loss, but Elizabeth Miller, of FDA's division for non- prescription drugs and health fraud, said that "the data simply does not support this -- any loss is from severe calorie restriction. Not from the HCG." It also notes that hCG is not on the FDA's list of approved ingredients for homeopathic remedies.
Reported by the American Association for Justice
House Democrats request hearing from pharmaceutical firms on shortages
December 4, 2011
CQ (12/1, Norman, Subscription Publication) reported, "House Democrats on Thursday asked for a hearing with drugmakers following a Wednesday hearing at which medical and pharmaceutical experts discussed the impact of prescription medicine shortages. The next logical step in an investigation of shortages is to call in manufacturers who are experiencing them," said Elijah E. Cummings of Maryland and Danny K. Davis of Illinois. The following "hearing should include Bedford Laboratories, APP Pharmaceuticals, Hospira, Teva Pharmaceuticals and Sandoz Pharmaceuticals, they said, all manufacturers of drugs on the Food and Drug Administration shortage list."
Reported by the American Association for Justice
GM promises to buy back Volts from owners concerned about fire hazard
December 4, 2011
The AP (12/1) reported, "General Motors will buy Chevrolet Volts back from any owner who is afraid the electric cars will catch fire, the company's CEO said Thursday." During "an exclusive interview with The Associated Press, CEO Dan Akerson insisted that the cars are safe, but said the company will purchase the Volts because it wants to keep customers happy." He "said that if necessary, GM will recall the more than 6,000 Volts now on the road in the US and repair them once the company and federal safety regulators figure out what caused the fires."
The New York Times (12/1, B4, Vlasic, Bunkley, Subscription Publication) reported, "Such a buyback is unusual for car companies, which typically institute recalls when regulators or customers report problems with cars or parts." Notably, the "Volt has come under scrutiny after the National Highway Transportation Safety Administration said on Nov. 25 that it had opened a defect investigation into the car's 400-pound battery pack."
The Financial Times (12/1, Simon, Subscription Publication) noted the comments by GM's CEO, but points out that the results of the National Highway Traffic Safety Administration's investigation into the cause of the fires could adversely affect the market for electric cars, which are being touted as a replacement for fuel vehicles. So far, most major car manufacturers intend to build electric vehicles, and this incident could hinder those plans. Reuters (12/1, Klayman, Ingrassia) also covered the story.
Reported by the American Association for Justice
Critics slam overmedication of foster kids
December 4, 2011
ABC World News (12/1, story 4, 4:05, Sawyer) reported that an ABC News "one-year investigation into foster care children" revealed that "so many of them [are] overmedicated with multiple, powerful mind-altering drugs, often used for disorders the children don't have. Critics say it is happening because of kind of an unholy convergence: Our taxpayer Medicaid dollars pay for the drugs, the pharmaceutical companies see a market, and a lot of times, doctors can move through many patients fast." ABC News correspondent Sharyn Alfonsi added that "some states have now started requiring a second opinion by a doctor before some medication is dispensed." Florida is "now kicking high prescribing doctors out of the Medicaid program. Still, critics say too many foster care children are being pushed through the system...with pill after pill."
Reported by the American Association for Justice
Takeda could face thousands of lawsuits over Actos' alleged cancer link
December 4, 2011
Bloomberg News (12/1, Feeley) reported, Takeda Pharmaceutical Co. "may face as many as 10,000 lawsuits in US courts over allegations that its Actos [pioglitazone] diabetes drug causes bladder cancer, and a group of judges is preparing to decide where they should be consolidated." Several months ago, "US regulators found...that an analysis of a company-sponsored study showed some users of Actos, the world's best-selling diabetes medication, faced an increased risk of developing the potentially fatal disease." Bloomberg News adds, "The evidence linking Actos to bladder cancer "is unusually strong and clear," Paul J. Pennock, a New York-based lawyer representing former users of the drug, said in a telephone interview."
Reported by the American Association for Justice
Lawmakers seek answers to national medication shortage
December 1, 2011
CQ (11/30, Bristol, Subscription Publication) reported, "Chemotherapy drug shortages could increase medical errors and force physicians to ration care, medical and pharmaceutical experts told House subcommittee members Wednesday." Experts "recommend development of contingency plans for critical drugs for which there is only one manufacture or been stockpiling of some drugs" and also "recommended changes to the reimbursement system, including increasing Medicare payments for generics after several years to create more incentives for manufacturers." Witnesses also want Congress to "pass pending legislation which would require manufacturers to confidentially notify FDA when they experience production problems or discontinue a problem (HR 2245, S 296)."
Modern Healthcare (11/30, Zigmond, Subscription Publication) reported that the House Oversight and Government Reform Committee's health subcommittee heard witnesses testify "about the causes that have led to a shortage of life-saving drugs." Dr. Kasey Thompson, vice president of policy, planning and communications for the American Society of Health-system Pharmacists, "testified that while Medicare reimbursement policies may be partially to blame, his group's analysis shows that quality issues in the manufacturing process pose an even greater problem."
Reported by the American Association for Justice
Inspectors: Medicare should stop use of antipsychotics in nursing home patients
December 1, 2011
The AP (11/30, Perrone) reported, "Government inspectors told lawmakers Wednesday that Medicare officials need to do more to stop doctors from prescribing powerful psychiatric" medications "to nursing home patients with dementia, an unapproved practice that has flourished despite repeated government warnings." The antipsychotic medications are prescribed to treat "people suffering from schizophrenia and bipolar disorder, but they're also given to hundreds of thousands of elderly nursing home patients in the US to pacify aggressive behavior related to dementia." But these medications "can also increase the risk of death in seniors, prompting the Food and Drug Administration to issue multiple warnings against prescribing the drugs for dementia."
"Nursing homes should be held accountable for inappropriately dispensing antipsychotic" medications "for Medicare beneficiaries and pay back the Part D program for those misused medicines, Department of Health and Human Services Inspector General Daniel Levinson said Wednesday," CQ (11/30, Bristol, Subscription Publication) reported. "The Centers for Medicare and Medicaid Service (CMS) is emphasizing non-pharmacological interventions for patients who did not have a diagnosis of psychosis or might not be candidates for the drugs." Patrick Conway, chief medical officer and director for the CMS Office Clinical Standards and Quality, stated that "in addition to improving education for providers, prescribers and patients' families, the agency is strengthening current rules and eliminating conflicts of interest that may influence prescribing."
Bloomberg News (11/30, Wayne) reported, "Medicare improperly paid about $116 million in the first half of 2007 for prescriptions filled in nursing homes for a class of drugs called atypical anti-psychotics, Daniel Levinson told the Senate Committee on Aging in a hearing today." The "anti-psychotics include AstraZeneca PIc (AZN)'s Seroquel and Ei Lilly & Co. (LLY)"s Zeprexa.
Reported by the American Association for Justice
Study: Failure to notify patients of test results main reason for malpractice suits
November 29, 2011
The Washington Post /Kaiser Health News (11/28, Andrews) reported that a new "study in the Journal of the American College of Radiology found that annual medical malpractice payouts for communication breakdowns, including failing to share test results, more than quadrupled nationally between 1991 and 2010, to $91 million." In order to reach this conclusion, researchers analyzed "medical malpractice claims from 425 hospitals and 52,000 providers." They found that "of the 306 cases in which test results were specifically cited as a factor in a malpractice case, the most common problem - it occurred almost half the time - was that the patient didn't receive the test results." Failure to notify clinicians of test results was also another major problem
Reported by the American Association for Justice
Archdiocese of Chicago agrees to settle sexual abuse case for $3.2M
November 16, 2011
The AP (11/15) reported, "Attorneys for a victim of convicted pedophile and former Roman Catholic priest Daniel McCormack have reached a $3.2 million settlement with the Archdiocese of Chicago and Cardinal Francis George. Chicago-based law firms Hilfman & Martin and Abels & Annes announced the agreement Tuesday." McCormack admitted to having abused five children. This particular "victim was 10 to 12 years old during the abuse."
Reported by the American Association for Justice
FDA urged to issue more alerts about drug risks
November 16, 2011
The New York Times' "Prescriptions" blog (11/15, Japsen) reported that FDA efforts "to issue 'safety signals' when it is alerted to potential health risks of prescription drugs isn't working well to notify the public or guide doctors to alternative medicines, new research indicates." In a short online article published Monday in The Archives of Internal Medicine, two doctors of pharmacy wrote that about "half of the potential 'safety signals' about adverse events" listed on the FDA's website from 2008 through 2010 "resulted in labeling changes, but most were listed in an 'updated Warnings and Precautions section' without guidance as to what action should be taken." They urged revision of the postings to better highlight potential safety indications, stating healthcare professionals and consumers are advised against taking action on listed potential safety signals, even though they indicate serious risk. CDER doctors noted the FDA is working to improve drug safety surveillance and analysis.
Reported by the American Association for Justice
Toy-related injuries, deaths remain high despite new safety rules
November 16, 2011
USA Today (11/15, O'Donnell) reported, "Toy recalls have been declining since a tough new product-safety law was enacted in 2008, which regulators say shows consumers should be more confident than ever this holiday season." Data show 34 toys were recalled "in the 2011 fiscal year, ended Sept. 30, down from 172 in 2008." But, a new "Consumer Product Safety Commission report...shows toy-related deaths of kids younger than 15 increased last year, and injuries remain alarmingly high, says CPSC Chairman Inez Tenenbaum." There were 17 toy- related child deaths last year, an increase from 12 in 2010. In addition, the number of children treated at ERs for toy-related injuries remained the same as in previous years.
Reported by the American Association for Justice
U.S. Supreme Court Agrees to Hear Indianapolis Homeowners’ Appeal in Suit against City for Unequal Treatment in Collection of Sewer Tax
November 15, 2011
The Supreme Court of the United States has granted a petition for certiorari in the case of the Christine Armour v. City of Indianapolis. The plaintiffs in the case are homeowners of 31 properties who contend that they were treated unfairly, and in violation of the U.S. Constitution, when the City forgave the sewer tax assessment for all homeowners in their subdivision who were paying in installments but granted no forgiveness or refund to the plaintiff homeowners who had paid in one lump sum. They were stuck with paying the full assessment.
In 2004, the City had assessed each property $9,278 for a sanitary sewer project in the Northern Estates subdivision. The following year, the Indianapolis Board of Public Works decided to change the way it financed sewer projects and while doing so, adopted a policy which forgave 90% or more of the sewer assessments to the residents of Northern Estates who had elected to pay in installments. The Board, however, denied any forgiveness to those homeowners who had paid in one lump sum which resulted in the lump sum payers being out of pocket the full amount of $9,278 while many of their neighbors paid only $309 for exactly the same benefit.
In December of 2009, the Indiana Court of Appeals concluded that this differing treatment of identically situated homeowners violated the Equal Protection Clause of the U.S. Constitution.The City of Indianapolis was ordered to pay back $8,968 to the homeowners in addition to paying interest and attorneys’ fees. The case then moved to the Indiana Supreme Court, where the majority ruled in favor of the City, reversing the judgment in a 3-2 decision in May of 2011. Now, the U.S. Supreme Court has decided to take up the issue.
Ron Waicukauski, one of the attorneys for the homeowners, commented: “The Supreme Court only accepts about one case out of a hundred. We’re thrilled that they’ve granted our petition and we are hopeful the Court will act to correct the injustice that occurred when the City forgave the installment payers but refused to extend forgiveness to the homeowners who had paid in full.” The case is expected to be heard by the U.S. Supreme Court during February 2012.
Price Waicukauski & Riley, LLC, of Indianapolis, focuses on complex plaintiff’s litigation and has represented the plaintiffs during the several years of this litigation. In the Supreme Court, the plaintiffs are also being represented by Roy Englert and Mark Stancil of Robbins, Russell, Englert, Orseck, Untereiner & Sauber LLP of Washington, D.C., a firm with a specialty in Supreme Court Practice.
Source: Press Release and IndyStar
SCOTUS expected to announce it will hear challenge to healthcare law
November 14, 2011
A front-page story in the New York Times (11/13, A1, Liptak, Subscription Publication) asked, "If the federal government can require people to purchase health insurance, what else can it force them to do? More to the point, what can't the government compel citizens to do?" The piece noted that these "questions have been the toughest ones for the Obama administration's lawyers to answer in court appearances around the country over the past six months. And they are likely to emerge again if, as expected, the Supreme Court...agrees to be the final arbiter of the challenge to President Obama's signature health care initiative."
The Los Angeles Times (11/13, Savage, Levey) reported, "After a year and a half of legal skirmishing, President Obama's embattled healthcare law has arrived at the Supreme Court riding a surprising winning streak and carrying a constitutional stamp of approval from prominent conservative judges. Only three of the 12 appellate judges who have reviewed the law have decided it is unconstitutional to require all Americans to have health insurance," and "not a single appeals court judge has said the entire law must be tossed out, the position advocated by Florida and 25 other Republican states leading the legal assault." The Supreme Court "is expected to announce as soon as Monday" that it will hear the Florida case, "the largest and broadest challenge" to the law.
The Washington Post (11/13, Barnes) reported, "Today, there are unmistakable comparisons to the court's action on the Social Security Act of 1935 as the current justices consider whether to accept a constitutional challenge of the 2010 Affordable Care Act." The Post noted, "But there is an answer to the obvious question of why the health-care act might not be constitutional while Social Security -- and its offshoot Medicare -- are. They were built on separate constitutional powers."
NYTimes says Silberman opinion should bode well for healthcare law. The New York Times (11/11, Subscription Publication) editorialized, "A federal appeals court in the District of Columbia endorsed the constitutionality of healthcare reform this week in an opinion as notable for its authorship as for its legal reasoning. The majority opinion in the 2-to-1 decision was written by Judge Laurence Silberman, a stalwart of conservative jurisprudence whose views are said to be enormously influential in conservative legal circles. ... It is significant that prominent Republican judges have agreed with the Obama administration that a core element of the health reform law is constitutional. If the Supreme Court takes up the issue on appeal, it should affirm these judgments."
Reported by the American Association for Justice
Regulators warn small magnets can be hazardous to children
November 11, 2011
The Chicago Tribune (11/11, Gabler) reports the US Consumer Product Safety Commission "are warning parents that high-powered magnets marketed as desk toys and stress relievers for adults can pose a deadly hazard to kids." Kids "have been known to swallow the tiny magnets, which can then attract each other inside the body, causing small holes in the stomach and intestines, intestinal blockage, blood poisoning or other serious injuries that can be fatal."
The AP (11/11) reports the agency "has received 14 reports of problems with the magnets - up from seven reports last year and one in 2009." The children "ranged in age from 18 months to 15 years old. Eleven of the children required surgery to remove the magnets." CPSC Chairman Inez Tenenbaum said, "The symptoms can pose as a cold or the flu and send parents to the doctor multiple times before an X-ray is done revealing the blockage."
Reported by the American Association for Justice
FDA issues retailer warnings on cigarette sales to minors, other tobacco infractions
November 11, 2011
In continuing coverage, USA Today (11/11, Jackson) reports, "The Obama administration sent letters to 1,200 businesses today with an urgent warning: Don't sell cigarettes to kids. The letters from the Food and Drug Administration follow 'an aggressive inspection campaign and remind retailers of their legal responsibility to protect our children,' said White House spokesman Jay Carney.
The Hill (11/11, Pecquet) reports in its "Healthwatch" blog that Health and Human Services Secretary Kathleen Sebelius "touted the figures in a new blog post highlighting the administration's efforts to curb childhood smoking in the wake of a legal defeat this week." In the post, she "vowed that the administration would continue its efforts after a federal judge on Monday blocked graphic new cigarette warnings. District of Columbia Judge Richard Leon blocked the warning requirement from going into effect until a court rules on whether they violate the First Amendment."
CQ (11/11, Subscription Publication) adds that the Family Smoking Prevention and Tobacco Control Act of 2009 gives FDA the power to contract with states and territories to run compliance checks of tobacco retailers, and this year the agency "awarded contracts totaling more than $24 million to 38 states, for such inspections." It quoted FDA Commissioner Margaret Hamburg saying that, "It should worry every parent that 20 percent of U.S. high school students smoke cigarettes."
The AP (11/11, Felberbaum) interviews Dr. Lawrence Deyton, director of the FDA's Center for Tobacco Products, who says that retailers are "on the front line of helping to prevent our kids from initiating tobacco use. ... It's very important for every neighborhood to know that their retailers are enforcing this new law." The AP also notes that besides looking for illegal sales of tobacco to minors, inspectors check for other violations, such as selling single cigarettes, handing out samples or promotional materials like hats and T-shirts advertising tobacco, selling cigarettes that are flavored or come in packs marked with words like "light," "mild," or "low-tar." Retailers have 15 days to respond to the warnings letters, and face escalating fines and possible loss of the ability to sell tobacco for further violations.
Bloomberg News (11/11, Staiti) and Reuters (11/11, Selyukh, Wohl) also report the story.
Several local papers, including the Boston Globe (11/10, Kotz) and the Colorado Springs (CO) Gazette (11/10, Cotter), also report the local recipients of the FDA warning letters.
Reported by the American Association for Justice
Obama signs executive order on prescription drug availability
November 1, 2011
Fox News' Special Report (10/31, Baier) reported, "President Obama today continued his effort to appear as proactive as possible in the remedy for, as he says, an inactive Republican Congress. He addressed a problem we told you about earlier this month, the shortage of some prescription drugs." White House correspondent Ed Henry added, "President Obama still can't convince Congress to pass his jobs bill, so he brought a pharmacy manager and a cancer patient to the Oval Office to explain his move to deal with drug shortages that are putting lives at risk."
ABC World News (10/31, story 4, 0:30, Sawyer) reported that "for almost a year, we at 'World News' have been reporting on the growing drug shortages in this country. Chemotherapy drugs, antibiotics, heart medications, even those crash cart drugs used in emergencies. Well, today President Obama took action, signing an executive order, no Congressional approval necessary, to force drug companies to take action when there's a shortage on the horizon. The most immediate change, a crackdown on price gouging due to the shortages, and that will kick in, starting tomorrow." CBS (11/1) reports, "Health and Human Services Secretary Kathleen Sebelius and FDA Commissioner Peggy Hamburg were expected to join Obama at the White House as he signs the executive order."
In a story carried by more than 185 news sources, the AP (11/1) reports, "An Obama administration analysis concluded a big part of the problem is rising demand, especially for cancer drugs, that those companies haven't been able to boost production to meet. But, 'the main cause of drug shortages is economic,' argued Dr. Thomas J. Smith of Johns Hopkins' Sidney Kimmel Comprehensive Cancer Center and Virginia Commonwealth University pharmacist Mandy Gatesman in this week's New England Journal of Medicine."
The Hill (10/31, Pecquet) reports in its "Healthwatch" blog, "Efforts announced Monday 'will give us extra time to work with the industry to prevent, reduce or mitigate the shortage,' Health and Human Services Secretary Kathleen Sebelius told reporters on a conference call." She continued, "While we can't control all the factors that cause the shortages - starting with the fact that demand is outpacing supply - there are steps we can take. We can work with manufacturers to fix quality issues. We can work with other firms to increase production. And (the new order) will lead to earlier FDA notification of any impending shortages of certain prescription drugs."
Reported by the American Association for Justice
Studies Prove that Women Taking Yaz, Yasmin Have an Increased Blood Clot Risk of 75 Percent
October 28, 2011
The U.S. Food and Drug Administration (FDA) and the BMJ, f/n/a British Medical Journal, recently released studies, which prove that woman taking Yaz, Yasmin have a 75 percent greater chance of experiencing a serious blood clot.
Source: BMJ Study, New York Times, and NewsInferno
Study finds no link between cell phones, cancer
October 21, 2011
Major media sources provided coverage of a large study from Denmark that found no association between cell phone use and elevated cancer rates.
The AP (10/21) reports that the "Danish study of more than 350,000 people," the largest so far undertaken, "concluded there was no difference in cancer rates between people who had used a cellphone for about a decade and those who did not. ... Cancer rates in people who used cellphones for about 10 years were similar to rates in people without a cellphone. Cellphone users were also no more likely to get a tumor in the part of the brain closest to where phones are usually held against the head." However, groups including "MobileWise...said the study wasn't long enough to consider the long-term risk, since brain tumors can take decades to develop." The study was published in BMJ.
Bloomberg News (10/21, Gerlin) notes that "the research is the largest of its type and used data that was already available, instead of retrospectively interviewing phone subscribers whose recall could be selective or unreliable, the scientists said."
Reported by the American Association for Justice
Reports 15 Deaths Due To Growing Shortages Of Medications
October 14, 2011
FOX News (10/14, Roberts) reports on its website that "99.5 percent of hospitals have experienced a drug shortage in the past six months," and that "for many critical drugs, the cupboard is basically bare." In some cases, hospitals have turned to alternative suppliers, and paid anywhere "from 100-fold to 1,000-fold," for medications. So far, "the American Society of Health System Pharmacists reports at least 15 deaths that are directly attributable to the drug shortage." Some "Gray Market" Companies Selling At Substantial Markup. CBS Evening News (10/13, story 5, 3:35, Pelley) reported, "There is a critical shortage of life-saving drugs in this country. This week, five drugs were added to a list of more than 200 reported to be in short supply. Now it turns out some companies are hoarding these drugs to drive the price up." CBS (Keteyian) explained, "The record drug shortage has opened the door for so-called gray market companies that exploit the short supply." So "Congressman Elijah Cummings has launched an investigation into drug shortage profiteering." CBS (10/14) also offers a version of this story on its website.
Reported by the American Assocation for Justice
Half of children's car booster seats present risks
October 13, 2011
USA Today (10/13, O'Donnell) reports the Insurance Institute for Highway Safety (IIHS) found that "half of children's car booster seats aren't good enough to ensure a proper fit with safety belts" and recommended "parents avoid" six of them. The IIHS says "ti's impossible to tell which booster seats are better just by comparing prices, brands or features." Still, "the IIHS says booster seats have improved in the three years it has been testing them."
The Washington Post (10/13, Shaver) reports, "Of 83 booster seats evaluated, 41 fell into the 'check fit' category, meaning they might not provide adequate seat-belt fit for all children in all vehicles," 31 made the "best bets" category, properly positioning the seat belt in all vehicles. "Five boosters were ranked 'good bets' for providing a proper seat-belt fit in most vehicles."
This story is also covered by the AP (10/13), the website of ABC News (10/13, Stark), the "Wheels" blog of the New York Times (10/13, Jensen, Subscription Publication), and the "Driver's Seat" blog of the Wall Street Journal (10/13, Welsh, Subscription Publication).
Reported by the American Association for Justice
Vitamins associated with increased risk of death in older women
October 11, 2011
The CBS Evening News (10/10, story 8, 0:30, O'Donnell) reported, "More than half of American adults take dietary supplements."
ABC World News (10/10, lead story, 2:40, Sawyer) added, "A major new study in an important medical journal finds in some cases the supplements either do no good or could increase the risk of dying from cancer or heart disease."
NBC Nightly News (10/10, lead story, 2:40, Williams) reported that the study published in the Archives of Internal medicine found that "women who take supplements, including multivitamins, appear to have slightly higher death rates." NBC chief science correspondent Robert Bazell explained, "Researchers followed more than 38,000 women average age 61 for 19 years. They found higher death rates in those taking multivitamins, vitamin B-6, folic acid, zinc, magnesium, copper and iron."
Reported by the American Association for Justice
Taskforce warns against blood test for prostate cancer
October 10, 2011
ABC World News (10/7, lead story, 2:15, Sawyer) reported, "An earthquake today in the debate over men and prostate cancer" regarding a "simple blood test called a PSA. Twenty million men use it to find out if they show a sign of risk, yet today, a government task force is saying healthy men should skip that test, arguing that the treatment that often follows the test may not be worth the consequences."
Healthcare field reacts to PSA downgrading. On its front page, the New York Times (10/8, A1, Harris, Subscription Publication) continues coverage of the news that the US Preventive Services Task Force (USPSTF) "found that a PSA blood test to screen for prostate cancer does not save lives, but results in needless medical procedures that have left tens of thousands of men impotent, incontinent or both." However, "urologists -- the doctors who most often treat prostate cancer -- promised to fight. The American Urological Association issued a statement saying that the recommendation 'will ultimately do more harm than good.'"
Reported by the American Association for Justice
Death toll in cantaloupe-linked listeria outbreak hits 18, 100 illnesses confirmed
October 6, 2011
The AP (10/5, Jalonick) reported that federal health officials "have raised the death toll to 18 in an outbreak of listeria in cantaloupe. The Centers for Disease Control and Prevention said Tuesday it has confirmed 100 illnesses in 20 states, including the 18 deaths. The agency said it has confirmed two additional deaths in Colorado and one in Kansas since last week." The death toll is almost certain to rise, as listeria-linked outbreaks can have incubation periods approaching two months.
The Los Angeles Times (10/5) noted that it is "the nation's deadliest food-borne outbreak in more than a decade," and the Jensen Farms in Colorado "recalled its cantaloupes on Sept. 14 after the melons were found to have been contaminated by four strains of Listeria monocytogenes bacteria." MSNBC (10/5, Aleccia) added that in the outbreak, "most of those who became ill are older than 60, with an average age of 79. Of 93 people for whom information is available, 91 were hospitalized."
Bloomberg News (10/5, Flinn) noted that the Centers for Disease Control and Prevention in its most recent update assures consumers that cantaloupes known not to have originated at the Jensen Farm in Colorado "are safe to eat."
USA Today (10/5, Weise) reported that FDA Commissioner Margaret Hamburg "said Tuesday that her agency is investigating the cause of the outbreak. The FDA and CDC have had teams in Jensen Farms fields and packing sheds, testing the soil, water and surfaces for clues. Listeria bacteria grow in moist, muddy conditions and are often carried by animals."
The Washington Times (10/5, Richardson) reported that for the residents of Rocky Ford, Colorado, the outbreak at Jensen Farms, nearly 100 miles to the east, "delivered a body blow to Rocky Ford's reputation for top-notch melon and its small but scrappy farming culture."
Produce distributor, grower sued over cantaloupe outbreak. The Houston Chronicle (10/5, Pack) reported that South Texas produce grower and distributor Frontera Produce has been named in at least three lawsuits over a listeria outbreak tied to contaminated cantaloupes. One lawsuit was filed Monday in a Texas state court by an Oklahoma burse who was hospitalized for over two weeks with a listeria infection. Two other suits were filed by a Seattle law firm, one in Oklahoma and another in a federal court in Maryland, by relatives of persons after falling victim to listeriosis. Also named in the lawsuits was grower Jensen Farms of Colorado.
Reported by the American Association for Justice
Blue Shield removes coverage for breast cancer drug
October 4, 2011
The New York Times (10/3, Pollack, Subscription Publication) reported, "Blue Shield of California will no longer pay for the use of the drug Avastin to treat breast cancer, a sign that support for the widely debated and expensive treatment may be eroding among health plans." The Times notes, "Blue Shield, with 3.2 million members, is apparently the first large insurance company to end payments since a federal advisory committee unanimously recommended in June that the Food and Drug Administration rescind Avastin's approval as a treatment for breast cancer, saying the drug did not really help patients. Shortly after the F.D.A. advisory committee's negative vote, a panel of breast cancer doctors convened by the National Comprehensive Cancer Network, an organization of major cancer hospitals, reaffirmed that Avastin was 'an appropriate therapeutic option for metastatic breast cancer'...important because Medicare and UnitedHealthcare are supposed to pay for drugs listed in the cancer network's guidelines."
Reported by the American Association for Justice
Tyson recalls ground beef over E. coli threat
September 30, 2011
The AP (9/29) reported that Tyson Fresh Meats Inc. "is recalling about 131,300 pounds of ground beef because a family in Ohio fell ill after eating meat produced by the company that was contaminated with E. coli, the US Department of Agriculture reported Wednesday." The meat was produced at a plant in Emporia, Kansas, and a sample of ground beef taken from the family's home tested positive for the bacteria. No other illnesses were reported in connection with the voluntary recall by Tyson.
Noting E. coli incident in speaker's district, House Democrat blasts GOP stance on food-safety budget. The Hill (9/29, Lillis) reported in its "Healthwatch" blog that a leading Democrat "is blasting Republicans for scaling back food-safety precautions after four children living in the district of House Speaker John Boehner (R-Ohio) were sickened by contaminated beef." Rep. Rosa DeLauro (D-Conn.), ranking member of a House appropriations subcommittee, "said the episode 'should serve as a wake-up call' for Boehner and other GOP leaders that Congress must take greater steps to prevent foodborne illness."
Reported by the American Association for Justice
FDA cracks down on false LASIK claims
September 30, 2011
HealthDay (9/30, Mann) reports, "The US Food and Drug Administration is once again cracking down on eye care professionals who make false safety claims and promises about the popular LASIK eye surgery." In its Letter to Eye Care Professionals, which it issued this week, the FDA "is now giving eye doctors 90 days to get in line and update any advertising or promotional materials that make false claims. After this time, the agency will take regulatory action, said FDA spokeswoman Erica Jefferson."
Reported by the American Association for Justice
Common NSAIDs may increase heart risk
September 30, 2011
CDC, FDA predict cantaloupe illnesses, deaths will rise
September 29, 2011
Survey finds health insurance costing more, covering less
September 28, 2011
FDA concerned by higher risk of blood clots in women using drospirenone
September 27, 2011
Primatene mist inhalers to go off market after December 31
September 23, 2011
Judge rules Teva bound to cover liability over tainted propofol
September 21, 2011
Bloomberg News (9/21, Feeley) reports, "Baxter International Inc. won a bid to force Teva Pharmaceutical Industries Ltd. (TEVA) to pay costs of defending Nevada lawsuits alleging that the drugmakers' sales of the anesthetic propofol led to patients developing hepatitis." Delaware Chancery Court Judge Travis Laster ruled that the conclusion of an arbitration panel that "found that Teva was bound by an agreement to cover all liability tied to claims that tainted vials of propofol caused colonoscopy patients to develop hepatitis," was "valid and enforceable." Under that ruling, "Teva faces almost 300 lawsuits stemming from a hepatitis C outbreak three years ago in southern Nevada," in which "Nevada health officials blamed the reuse of propofol vials for infecting patients with the incurable liver disease." The case is Baxter International Inc. (BAX) v. Teva Pharmaceuticals USA Inc., 6819, Delaware Chancery Court (Wilmington.)
Reported by the American Association for Justice
HHS grants to help states conduct insurance rate reviews
September 21, 2011
Several news outlets noted the announcement that HHS is providing grants to help states conduct insurance rate reviews. The coverage was positive for the most part, although some sources pointed out the insurance industry's objections. The Los Angeles Times (9/21, Levey) reports, "The Obama administration Tuesday announced $109 million in grants to states to help them beef up oversight of health insurers, a key goal of the healthcare law the president signed last year." These "grants come on the heels of new rules that require insurers to post on their websites explanations of premium increases exceeding 10% and to justify the hikes to state and federal regulators, who also will post them starting this year." Steve Larsen, "who oversees the insurance efforts at" HHS, said, "We absolutely expect for this...to help have a moderating influence on premiums."
Reported by the American Association for Justice
Study says physician fees major factor in higher overall US healthcare costs
September 9, 2011
The New York Times (9/8, A19, Pear, Subscription Publication) reports, "Doctors are paid higher fees in the United States than in several other countries, and this is a major factor in the nation's higher overall cost of health care," according to a study published Sept. 8 in the journal Health Affairs. The study "found that the incomes of primary care doctors and orthopedic surgeons were substantially higher in the United States than in other countries." What's more, "the difference results mainly from higher fees, not from higher costs of the doctors' medical practice, a larger number or volume of services or higher medical school tuition."
For example, "Medicare and private insurers pay US physicians more for their services than public and private insurers pay for the same services in other countries; in some cases American doctors are paid double for the same services," MedPage Today (9/8, Walker) reports. Overall, "the US spends $7,538 per person on healthcare, or 16% of the nation's total gross domestic product (GDP)," and "spending on ambulatory care in physician offices accounts for 21.2% of the overall tab," the study found.
Reported by the American Association for Justice
Brain stent treatment may double risk of repeat stroke
September 8, 2011
The CBS Evening News (9/7, story 7, 0:25, Pelley) reported, "There was disappointing news today about the use of brain stents." A study published online Sept. 8 in the New England Journal of Medicine "found when the stents were used on patients who already had a stroke, they can more than double a risk of another stroke or even death when compared with...therapy or lifestyle changes."
On its front page, the New York Times (9/8, A1, Kolata, Subscription Publication) explains that in 2005, "the Food and Drug Administration approved the device...on the basis of a humanitarian exemption, which did not require solid evidence that it would prevent strokes." Now, "the finding that the devices actually more than doubled the rate of stroke or death raised serious questions about whether the FDA's procedures for approving such a medical device ended up putting patients at risk." Meanwhile, "Larry Kessler, an expert on medical devices and a former director in the FDA's Center for Devices and Radiological Health, said that the humanitarian exemption made sense sometimes, but that the new study showed its dangers."
Reported by the American Association for Justice
Johnson & Johnson faces suits over Levaquin and tendon ruptures
September 7, 2011
Bloomberg News (9/7, Feeley) reports that in a case in Atlantic City, New Jersey, Johnson & Johnson is being tried for having "failed to properly warn two New Jersey men that the antibiotic Levaquin could damage their tendons," and of having "downplayed Levaquin's risks in warning labels." J&J attorney Christy Jones said that the company "repeatedly warned doctors and patients about reports linking tendon ruptures to Levaquin, starting when it was approved for sale in the US in 1996." The story notes that "in 2008, the US Food and Drug Administration required all makers of antibiotics in Levaquin's class to beef up warnings about tendon ruptures." The company "faces more than 2,600 claims in US courts over the drug, court dockets show." The case is Beare v. Johnson & Johnson, L-196-10-MT, Superior Court of New Jersey for Atlantic County (Atlantic City).
Reported by the American Association for Justice
Automated defibrillators often fail, researchers say
September 6, 2011
MedPage Today (9/2, Walsh) reports that a research paper appearing online in the Annals of Emergency Medicine finds that the FDA "has received more than 1,000 reports over 15 years of deaths following failure of automated external defibrillators, a retrospective analysis showed. In 37 of the events, the defibrillator failed to even power on, and in 22% of the cases the device was unable to complete the heart rhythm analysis, according to Lawrence A. DeLuca Jr., MD, of the University of Arizona in Tucson, and colleagues." The most common failure, accounting for 45%, was when the defibrillator failed to deliver a shock recommended after rhythm analysis. Since in those cases a backup device was often successful when the primary defibrillator failed, the researchers recommended that public access programs provide backup units when possible.
Reported by the American Association for Justice
Sebelius: rules to protect consumers from rate hikes become effective
September 2, 2011
HHS Secretary Kathleen Sebelius writes in a Huffington Post (9/1) piece that a provision in the Affordable Care Act which will protect consumers against insurance industry abuses goes into effect today. She says that because of the provision, "insurers must submit a written justification every time they try to raise your premium by ten percent or more. As rate increases are proposed, that information will be posted in a clear, easy-to-understand format on the new consumer website Healthcare.gov." In addition, "rates will...be evaluated by experts to see whether they're justified, and that information will be made available to consumers too." Sebelius argues that because of the ACA, "the deck is no longer stacked in insurers' favor," and henceforth, insurers who attempt to increase premiums "by double digits" must "explain themselves."
Nevada Insurance Division taking comments on rate increases. The Las Vegas Sun (9/1, Ryan) reports, "The state Insurance Division will begun accepting consumer complaints about increases to company health insurance costs this week." The division must approve rate increases "for individuals and small employer groups," and now, under the Affordable Care Act stares must "give consumers a chance to express their feelings about these proposed premium hikes." To do that, "the state Insurance Division has installed a new section on its website" starting today, where people may register comments.
Reported by the American Association for Justice
FDA recommends surgical mesh be reclassified as "high risk"
September 2, 2011
Bloomberg News (9/1, Edney) reports, "A Food and Drug Administration staff recommendation" says that transvaginally implanted surgical mesh "products fail to lead to better outcomes than non-mesh repair and should be reclassified as posing a high risk to patients," and the mesh makers "may have to submit added safety data to regulators to keep their products on the market." Bloomberg News adds that a "change in risk classification may take several years to complete and the agency said it could consider a grace period for makers of products on the market to submit data to comply with a more stringent review."
Reported by the American Association for Justice
Cardiac implants, related infections on the rise
August 30, 2011
The New York Times (8/30, Bakalar, Subscription Publication) reports in "Vital Signs" that "the number of implantable cardiac devices in use has doubled since 1993, and the number of infections associated with them has more than tripled," according to a study published in The Journal of the American College of Cardiology. Investigators found that "the incidence of infection in 2008 increased to 2.4 percent from less than 1.5 percent in 2004." While "the reasons for the increase are not clear...the recipients' age and poorer health may be factors."
Reported by the American Association for Justice
PolitiFact calls Perry's tort reform claims "false"
August 29, 2011
The Hill (8/27, Baker) "Healthwatch" blog reported, "The website PolitiFact.com on Friday threw some cold water on Texas Gov. Rick Perry's (R) claims about tort reform in his state -- claims tort-reform supporters often tout as a model for other states." While campaigning, the governor has said that "Texas gained 21,000 new doctors because of malpractice reforms in his state." However, PolitiFact "found that in the years since Texas's tort reform law passed, the number of doctors in the state has risen only slightly more than the overall population." Therefore, the site called the claim "false."
Marilyn Werber Serafini also cited the PolitiFact analysis in NPR's (8/26) "Health" blog, noting that "Texas has only about 13,000 more doctors in the state and the historic trends suggest that population growth was the driving factor." PolitiFact's Jon Greenberg also noted other aspects of "PerryCare," including that "'Rick Perry believes the best way for the federal government to improve health care is to stimulate job creation so more Americans are covered by employer-sponsored health plans,' according to his campaign website."
Additionally, the Daily Kos (8/28, Jcullen) highlighted a number of reports debunking Perry's tort reform claims. A July article from the Austin American-Statesman reported that "almost half of the state's job growth in the past two years came in the education, health care and government sectors." More recently, an August Washington Post article noted Perry's job growth claims but said "he is less forthcoming about the 26% of Texas residents who lack health insurance - ranking 50th among the states - compared with a national average of 17%." And a Public Citizen report said Perry's 2003 tort reforms haven't tamed health costs but "Texas Medicare reimbursements have actually been rising faster than the rest of the country."
Apology laws working to reduce medical malpractice suits, study says. Christopher Shea reported in the Wall Street Journal (8/26) "Review Ideas Market" blog on a study concluding that apology laws work to cut medical malpractice suits. Researchers Elaine Liu and Benjamin Ho inspected 225,000 malpractice payments between 1991 and 2009 among states with and without apology laws. States with apology laws settled the most serious malpractice cases approximately 20 percent faster and payments decreased by $55,000 to $73,000. Liu and Ho found similar trends among slightly serious cases. The study is to be published in an upcoming issue of Journal of Risk and Uncertainty, Shea noted.
Reported by the American Association for Justice
Medtronic accused of ignoring insulin pump security concerns
August 26, 2011
The AP (8/26, Robertson) reports that Jay Radcliffe, a user of a Medtronic Inc. insulin pump, had discovered through his own efforts "serious security holes" that would allow someone "to program a special remote control to command strangers' pumps to dispense the wrong dosage of insulin." When he attempted "to alert the company to the defects," he said that he was ignored. He then "revealed the details to The Associated Press ahead of a planned news conference." Radcliffe also contacted "the Department of Homeland Security, which examined his research, [and] helped make the introduction to Medtronic, [but] his calls and e-mails went unanswered." Despite this, Radliffe "said Medtronic customers should continue to use their pumps, as the techniques he developed are hard to execute in the real world." Meanwhile, Reps. Anna Eshoo (D-CA) Edward Markey (D-MA) "have asked the Government Accountability Office...to evaluate the government's efforts to identify the risks of implants and other medical devices that use wireless communication."
The Minneapolis Star Tribune (8/26, Moore) adds that "Radcliffe and others suspect the security vulnerabilities could extend to other devices, such as pacemakers and implantable heart defibrillators." Medtronic CEO Omar Ishrak said that "Security systems on new pumps will improve going forward," adding that "there's never been an incidence of pump hacking in the real world."
Reuters (8/26, Finkle) reports that "John Mastrototaro, a physician who serves as vice president of research and development for Medtronic's diabetes division," said, "The likelihood of this accidentally happening is nil." Radcliffe "called on the public to pressure Medtronic to take action to make the devices safer, even though he said that the risk to any individual patient was extremely low." Mastrototaro "said it would be difficult to make changes to pumps already in use because of US FDA regulations that require device makers to get agency approval before changing anything in their products, including issuing software patches."
Reported by the American Association for Justice
New passenger protection rules take effect
August 25, 2011
Coverage of new passenger protection rules was widespread, particularly among local TV outlets, and mostly positive in tone, with the majority of reports noting the rules seek to provide a "less stressful" travel experience for the consumer.
For example, the Raleigh News & Observer (8/24, Martin) said US DOT rules took effect Tuesday making passengers bumped from domestic flights eligible to receive up to $1,300 and requiring air carries to refund checked-baggage fees for lost luggage. Under the new rules, compensation for bumped flights increased from the previous maximum of $800, and last year's tarmac rules now apply to international flights. The rules "are the latest to be imposed by federal regulators over the last two years in response to several notorious cases of flight delays."
Under the headline, "New Rules Aim For More Passenger-Friendly Skies," NPR (8/24) said the new rules were designed to make flying more convenient, so all airline passengers "should like some new government regulations that took effect Tuesday." According to Secretary LaHood, the new passenger protections "will 'help ensure that air travelers receive the respect they deserve before, during and after their flight.'" FlyersRights.org President Kate Hanni praised the new rules and credited US DOT, saying: "It's the first time in history this DOT has taken on airline passenger issues, and [it] really is doing a very good job."
In its lede, Market Watch (8/24) said, "Fliers, the US has your back with new rules starting Tuesday." The report quotes Transportation Secretary Ray LaHood as saying, "The Obama administration believes consumers have the right to be treated fairly when they fly."
A San Francisco Chronicle (8/24, Parker) blog cited research by independent airline consultants Darryl Jenkins and Joshua Marks that found tarmac rules have caused more flight cancellations, a finding disputed by Secretary LaHood, who said in his blog: "'The number of flights canceled after tarmac delays of more than two hours -- the flights that could have conceivably been canceled to avoid violating the rule -- increased only slightly' since the rule took effect. But Jenkins says that's because airlines worried about penalties are not waiting two hours to cancel flights, they are canceling a lot more flights after 90 minutes to make sure they have time to get back to the gate and remove other planes if necessary, which leads to more flight cancellations throughout the system."
USA Today (8/24, Yu) noted in its Travel Section that the new DOT rules require air carriers to "prominently disclose all ancillary fees on their websites, including fees for checking bags."
On its website, CNN (8/24, Pawlowski) said the Association of Passenger Rights "applauded the rules, calling them long overdue. 'If you talk to most air travelers...traveling on the airlines is about as popular as the US Congress right now,' said Brandon Macsata, a spokesman for the group."
Reported by the American Association for Justice
FDA sees surge in complaints about all-metal hips
August 24, 2011
The New York Times (8/23, A1, Meier, Roberts, Subscription Publication) reports on its front page, "The federal government has received a surge in complaints in recent months about failed hip replacements," totaling "more than 5,000 reports since January about....metal-on-metal hips." The complaints are chiefly that an all-metal hip has had to be replaced "after only a few years," and "some patients have suffered crippling injuries caused by tiny particles of cobalt and chromium that the metal devices shed as they wear." As a result, "the FDA in May ordered producers to study how frequently the devices were failing and to examine the threat to patients." Now metal hips have "plummeted to about 5 percent of the market." One problem identified by the FDA's Dr. William Maisel is, "There is not an existing infrastructure for studying this kind of information."
Reported by the American Association for Justice
Study says many physicians face malpractice claims but few pay
August 18, 2011
The AP (8/18, Stobbe) reports that "Only 1 in 5 malpractice claims against doctors leads to a settlement or other payout," according to a new study published in the New England Journal of Medicine. The results "might seem to support a common opinion among doctors that most malpractice lawsuits are baseless, but the authors said the truth is more complicated than that." In fact, the researchers said, "given the expense and other difficulties involved in winning, it's doubtful most claims are filed on a greedy whim." The AP article details some of the specific findings of the study. Among these findings were that "fewer than 2 percent of doctors each year were the subject of a successful claim, in which the insurer had to pay a settlement or court judgment."
Reported by the American Association for Justice
Mylan pushes deal between FDA, generic drugmakers
August 17, 2011
The Pittsburgh Tribune-Review (8/17, Nixon) reports that the tentative agreement between generic drugmakers and the FDA to provide $299 million in funding annually to speed approval of generic drugs and pay for inspection of foreign plants "was pushed by Mylan Inc. to ensure the safety of generic drugs made overseas for the US market and to eliminate an incentive to ship American jobs to foreign countries." Heather Bresch, president of the Canonsburg, Pennsylvania producer, "said it costs 25 percent more to manufacture generics in the United States than overseas because foreign plants don't have to meet the same quality standards. 'I'm not asking to have an incentive to be in the US,' she said. 'But there should be parity and a level playing field.'" FDA spokeswoman Sandy Walsh "said the agency hopes to be able to take a proposal for a package of new fees, including $299 million from generic drugmakers, to Congress by January."
Reported by the American Association for Justice
Indiana State Fair Stage Collapse
August 16, 2011
Stage wreckage examined for clues...With five dead, quesitons are arising about whether the Indiana Fair should have scrubbled country music Sugarland show as high winds approached.
Source: The Wall Street Journal
GOP lawmakers may cut health reform funding to reduce deficit
August 15, 2011
Medication patches pose oft -overlooked danger to children's safety
August 15, 2011
MSNBC (8/12, Aleccia) reports that patient-safety experts are warning "parents, grandparents and other caregivers about potential hazards" to children posed by "transdermal medications. Some children have found the patches in home trash cans, or had them adhere to their skin after they rubbed off during close contact -- even a grandparent's hug -- leaving youngsters vulnerable to inadvertent overdoses of drugs ranging from painkillers and nitroglycerin to nicotine." Although thus far, "no complete data are available for child poisonings" related to medicated patches, government records indicate "at least four children have died and six have been hospitalized since 1997 after being exposed to just one type of transdermal drug, the fentanyl patch." Another three youth were "exposed to the drug, but the outcome wasn't recorded," according to the FDA's adverse-events data.
Reported by the American Association for Justice
J&J to settle criminal charge related to risperidone marketing
August 10, 2011
The New York Times /Bloomberg News (8/10, B8, Subscription Publication) reports, Johnson & Johnson has "reached an agreement in principle to settle a misdemeanor criminal charge related to the marketing of its antipsychotic drug Risperdal [risperidone]," according to its quarterly filing. Since 2004, federal prosecutors have been investigating the antipsychotic on allegations that it was being marketed "for unapproved uses," the pharmaceutical company said. The agreement in "principle on the criminal charge is on a single misdemeanor violation of the Food, Drug and Cosmetic Act" and "the Justice Department and the US Attorney in Philadelphia 'are continuing to pursue both criminal and civil actions,'" J&J said, adding that it had "adjusted the accrued amount in the second quarter of 2011 to cover the financial component of the proposed criminal settlement, but did not disclose an amount for the reserve."
Reported by the American Association for Justice
Excessive lab tests may leave some heart attack patients anemic
August 9, 2011
Bloomberg News (8/9, Renick) reports that "patients who enter hospitals due to heart attacks may be leaving with anemia caused by laboratory tests that draw too much blood, raising their risk of declining health and death," according to a study published in the Archives of Internal Medicine.
The Wall Street Journal (8/8, Hobson) "Health Blog" reported that for the study, investigators used data from more than 17,600 heart attack patients who were treated at 57 different hospitals.
McClatchy (8/9, Bavley) reports that the researchers found that while "none of these patients had anemia - depleted levels of red blood cells that carry oxygen - when they entered the hospital...one in five developed moderate to severe anemia during their hospital stay. The more blood they had drawn, the greater was their risk." The investigators found that "on average, the patients with hospital-acquired anemia had a total of 6 ounces of blood drawn, twice as much as the patients who didn't become anemic."
Reported by the American Association for Justice
DOJ subpoenas Merck over marketing of three drugs
August 9, 2011
The AP (8/9) reports that drugmaker Merck "says it has received a subpoena from federal prosecutors investigating the company's marketing of three drugs acquired through its 2009 acquisition of Schering Plough." Merck "disclosed the request for information from the Department of Justice in a regulatory filing Monday morning. The government is investigating marketing and selling of the brain cancer drug Temodar [temozolomide] and hepatitis C drugs PegIntron [peginterferon alfa-2b] and Intron A [Interferon alfa-2b, Recombinant for Injection]."
The Wall Street Journal (8/9, Loftus, Subscription Publication) reports that a Merck spokesman said the firm is cooperating with the probe.
Reported by the American Assocaiton for Justice
Study says single-payer healthcare system would save US $27.6 billion annually
August 5, 2011
Ford recalls 1.1 million pickup trucks with potentially-explosive gas tanks
August 2, 2011
The AP (8/1) reported over one million Ford pickup trucks are involved in a recall over concerns that metal straps securing the trucks' gas tanks "can rust, allowing them to fall, rupture and catch fire," the National Highway Traffic Safety Administration said Monday on its website. The recall includes some Ford F-150s between model years 1997 and 2004 and F-250s between model years 1997 and 1999. Also "affected are Lincoln Blackwood pickups from the 2002 and 2003 model years." Ford spokesman Wes Sherwood "said the company will notify owners in September to bring their trucks to dealers who will replace the straps with new ones that are coated to resist corrosion." The Chicago Tribune /Cars.com (8/1, Thomas) reported the 1.1 million vehicle recall is "because in certain cold-weather states, road chemicals can corrode the fuel tank straps." It adds, "The recall will begin on or around Sept. 12 in Connecticut, Delaware, Illinois, Indiana, Iowa, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Vermont, West Virginia, Wisconsin and Washington, D.C." These states utilize large amounts of salt and other chemicals on their roads during the winter, the Wall Street Journal (8/1, Welsh) reported in its "Drivers' Seat" blog. The NHTSA initiated an investigation into the gas tank issue a year ago. AFP (8/1) reported, the NHTSA's recall announcement said "prolonged exposure to road deicing chemicals may cause severe corrosion of the fuel tank straps which secure the tank to the vehicle." Additionally, about "120,000 trucks in Canada would be affected by the recall, Ford said." MarketWatch (8/1, Langlois) reported nearly 97 percent of complaints have come from trucks sold or driven in highly-corrosive parts of the country. Reuters (8/1, Klayman) reported identifying high-corrosive areas as a potential problem narrowed the recall from 2.7 million to 1.2 million. Before Ford installs permanent fixes, dealers can put in a cable to support the existing strap, the NHTSA said. It added that putting in a steel strap can serve as a permanent repair. Ford has reported three fires and an injury related to the defect.
Reported by the American Association for Justice
FDA issues warning alert about counterfeit "morning-after" pill
August 2, 2011
Medscape (7/29, Hitt) reported that the Food and Drug Administration on Friday warned against the use of a "'morning-after' pill called Evital, especially in some Hispanic communities." The drug "has not been approved for use" in the US; and according to the warning released by the Center for Drug Evaluation and Research's Division of Drug Information, the "packaging label of the potentially ineffective and suspect counterfeit version says, 'Evital Anticonceptivo de emergencia, 1.5 mg, 1 tablet.'" The product is manufactured by "Fluter Domull." CDER is requesting that persons "familiar with this product send an email to This e-mail address is being protected from spambots. You need JavaScript enabled to view it '; document.write( '' ); document.write( addy_text99982 ); document.write( '<\/a>' ); //--> This e-mail address is being protected from spambots. You need JavaScript enabled to view it to provide information or to ask questions about this product. 'Any information received is confidential and will be used only to help in FDA's effort to remove the potentially unsafe and ineffective versions from the US marketplace,'" the agency noted.
Reported by the American Association for Justice
Congress may relax FDA drug conflict rules
August 2, 2011
Reuters (8/2, Yukhananov) reports that, responding to complaints that it is too hard to find genuine experts to serve as FDA advisors, Congress is likely to relax the conflict-of-interest standard it set several years ago. Tighter conflict-of-interest rules adopted in 2007 bar FDA advisors from having even indirect financial ties to a related producer. Noting support among lawmakers at a recent Senate Health, Education, Labor and Pension hearing for easing the rule, the article adds that Dr. Janet Woodcock, head of the FDA's drugs center, told a House of Representatives hearing earlier this month that the agency has had "difficulty in recruiting highly qualified people" and "delays in having panels" due to the current rule. Last week, FDA Commissioner Margaret Hamburg told the Senate hearing that those calling for Congress to ease the current rule expressed "a valid concern."
Reported by the American Association for Justice
J&J unit to reduce acetaminophen dosage levels on OTC product labeling
July 28, 2011
The AP (7/28, Johnson) reported, Johnson & Johnson's McNeil Consumer Healthcare Division announced Thursday it is "reducing the maximum daily dose of its Extra Strength Tylenol pain reliever to lower risk of accidental overdose from acetaminophen," which is the "top cause of liver failure." According to Dow Jones Newswire (7/29, Lamar, Subscription Publication), McNeil said the change affects Extra Strength Tylenol sold in the US for which package labels starting this fall, will list the maximum daily dose as six pills (3,000 mg) down from eight daily pills (4,000 mg). Early next year, McNeil will reduce the maximum daily dose on labeling for Regular Strength Tylenol and other acetaminophen-containing products. CNN (7/28, Young) in its "The Chart" blog, reported that the J&J unit said acetaminophen is in "more than 600 over-the-counter and prescription medications including common pain relievers and fever reducers," such as NyQuil and Sudafed. Some people "accidentally exceed the recommended dose when taking multiple products at the same time, often...by not reading and following the dosing instructions," said McNeil VP Dr. Edwin Kuffner. Bloomberg News (7/29, Nussbaum) adds that McNeil said it is "working closely with fellow manufacturers to 'ensure consistency in dosing instructions' for acetaminophen." Notably, the FDA in January, announced limits on the agents "use in prescription pills," such as Percocet (acetaminophen and oxycodone) and Vicodin (acetaminophen and hydrocodone). ABC News (7/28, Francis) on its website noted that when the FDA "ordered drugmakers to reduce the amount of the painkiller in prescription medications by 50 percent, critics warned that prescription medications covered only 20 percent of the acetaminophen used in the US."
Reported by the American Association for Justice
AstraZeneca paid $647M to settle suits alleging antipsychotic caused diabetes
July 29, 2011
Bloomberg News (7/29, Feeley) reports, AstraZeneca Plc has "settled almost all lawsuits that claimed its antipsychotic drug Seroquel [quetiapine fumarate] causes diabetes in some users for a total of $647 million." AstraZeneca had "set aside the $647 million to resolve 28,461 suits alleging it knew Seroquel could cause diabetes in some users," the UK drug maker said in its second-quarter earnings report. Company officials said the reserve includes "money that may be used to settle about 250 unresolved cases." Miller Tabak & Co analyst Les Funtleyder said the fact that AstraZeneca was able to settle "for less than $1 billion" is a "real bargain when you look at what competitors such as Lilly have paid in settlements.'" Thus far, Eli Lilly has paid "at least $1.2 billion" to resolve similar lawsuits regarding Zyprexa (olanzapine).
Reported by the American Association for Justice
FDA issues warning letter regarding ISTA's promotional flyer for eye drops
July 28, 2011
Dow Jones Newswire (7/27, Dooren, Subscription Publication) reported that the Food and Drug Administration issued a warning letter to ISTA Pharmaceuticals Inc. on the grounds that the company's promotional material for Bromday (bromfenac ophthalmic solution) was false and misleading. Dow Jones quotes from a July 13 letter on the FDA website in which the agency concluded that a promotional flyer marketed by ISTA suggested Bromday is "safer than has been demonstrated"; omitted possible adverse events associated with using the eye drops; and neglected to caution against using the product while wearing contact lenses. Bromday was approved in October 2010 to treat pain and inflammation experienced by patients following cataract surgery.
Reported by the American Association for Justice
FDA warns concomitantly taking serotonergics with linezolid, methylene blue may be fatal
July 28, 2011
Bloomberg News (7/26, Peterson) reported that the FDA issued a safety communication Tuesday warning physicians that the Pfizer's Zyvox (linezolid) can cause a "potentially fatal central nervous system" reaction in patients concomitantly taking serotonin-specific reuptake inhibitor (SSRIs) and other serotonergic antidepressants. Cymbalta (duloxetine) and Paxil (paroxetine) as well as Pfizer's own SSRI Zoloft, are among the "29 psychiatric drugs" patients should stop temporarily when taking Zyvox, an antibiotic that treats infections such as MRSA and "nosocomial pneumonia." Conversely, Pfizer spokesperson Kristen Neese said the current US labeling for Zyvox "already includes prominent information" regarding potential "serotonergic interactions." Dow Jones Newswire (7/26, Dooren, Subscription Publication) reported that Zyvox inhibits an enzyme that help breakdown serotonin and concomitantly taking it with a serotonergic may cause toxic levels of serotonin to build up in the brain, the FDA explained in the alert. Separately, the agency also released a safety communication Tuesday alerting physicians that a similar adverse reaction may occur if the dye methylene blue is used in a diagnostic procedure in patients being treated with serotonergics.
MedPage Today (7/26, Gever) noted that the agency said both linezolid and methylene blue, which are "reversible monoamine oxidase inhibitors (MAOIs)," can cause serotonin syndrome even after serotonergics "have been stopped." The FDA said it had "received adverse event reports" for the two agents, including one death involving linezolid. However, the agency also stressed that patients taking serotonergics who present with "serious conditions" may still need the agents. For example, linezolid "may be required for patients with vancomycin-resistant enterococci" or certain MRSA infections. Similarly, methylene blue is needed for "emergency treatment of cyanide poisoning" and encephalopathy related to certain cancer drugs.
Medscape (7/26, Lowes) reported that in "nonemergency situations, most serotonergic drugs must be discontinued at least two weeks before the start of linezolid or methylene blue therapy"; and Prozac (fluoxetine) "requires a five-week lead time because of its longer half-life," according to the FDA.
Reported by the American Association for Justice
Zicam inventor will plead guilty to marketing unapproved flu remedy
July 28, 2011
The Los Angeles Times (7/27, Pfeifer) reported in its "Money & Company" blog that Zicam inventor Charles Hensley will "plead guilty to marketing an unapproved drug that he claimed in 2005 could prevent and treat flu." Hensley was indicted on 12 felony charges in May for marketing and selling Vira 38 without approval from the Food and Drug Administration. Hensley marketed the product online after failing to secure approval from Hong Kong authorities. The product was made for customers to apply with a swab inside their noses. The FDA ordered an end to production of the swabs in 2009 "because they can damage users' sense of smell." By pleading guilty to the charge, all others will be dismissed. A hearing has been scheduled for August 8.
Reported by the American Association for Justice
CDC says physicians improperly recommending breast, ovarian cancer screening
July 26, 2011
The Los Angeles Times (7/25, Brown) "Booster Shots" blog reported that, according to a CDC survey published in the journal Cancer, "physicians may not recommend screening often enough in women at high risk for breast and ovarian cancers...and that doctors may recommend screening too often for women at average risk of the diseases." The survey also found that "female physicians made the right recommendation more than males; ob-gyns did a better job than internists and family physicians. Urban doctors were more likely to comply with guidelines than rural doctors." The researchers recommended better education and development of genetic tools to help doctors assess patients' needs.
HealthDay (7/25, Dallas) added, "Women with mutations in the BRCA1 or BRCA2 gene or family histories of these mutations are at significantly greater risk for breast and ovarian cancer. Genetic counseling and testing are recommended for high-risk women because there are treatments that could significantly lower their risk for the diseases. These services are not recommended, however, for women who are not considered high-risk, because the harms of treatment outweigh the benefits, the study authors explained."
Reported by the American Association for Justice
FDA, EMA issue safety alerts for dronedarone
July 22, 2011
The New York Times (7/22, B7, Wilson, Subscription Publication) reports that yesterday, the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) "issued safety alerts on Thursday about Multaq [dronedarone], a drug approved two years ago to treat abnormal heart rhythms." The FDA "said a study of the drug in patients with a long-term form of the disease, known as atrial fibrillation, showed twice as many deaths as those who did not take the drug." In 2009, the drug "was approved for short-term arrhythmia lasting less than six months," with nearly 241,000 people in the US alone having received prescriptions since approval, the FDA noted.
Bloomberg News (7/21, Serafino) reported that the EMA "will finish its review" of Multaq "in September, the agency said" yesterday "in a statement on its website."
Dow Jones Newswire (7/21, Baba, Subscription Publication) reports that EMA will provide further guidance on the drug upon completion of its review. In the meantime, patients should not stop taking the drug without consulting their physician, and physicians who prescribe dronedarone should carefully monitor patients taking it, particularly making sure that patients are not going on to develop long-standing atrial fibrillation.
Reuters (7/22, Selyukh) reports that the FDA reviewed data derived from a clinical trial conducted by Sanofi-Aventis that the drugmaker halted on July 7.
According to HeartWire (7/21, Wood), the study, known as the PALLAS trial, "was stopped early when monitoring committees noted an increased risk of cardiovascular events among patients with permanent AF taking the drug compared with placebo."
MedPage Today (7/21, Peck) reported, "In the trial of more than 3,000 patients, there were 32 deaths in the dronedarone arm versus 14 in the placebo group (P=0.009), and for the combined endpoint of death or unplanned hospitalization, the difference was also highly significant, at 118 versus 81 (P=0.006)." In addition, "there were 17 strokes in the dronedarone arm versus seven in the controls (P=0.047)."
Reported by the American Association for Justice
FDA reviewing possible risk of esophageal cancer from bisphosphonates
July 22, 2011
The AP (7/22) reports the Food and Drug Administration said that it is investigating whether bisphosphonates increase the risk of "throat cancer after the publication of conflicting studies on the issue." The drugs are "routinely prescribed for osteoporosis in postmenopausal women and include brands like Fosamax (alendronate) and Boniva (ibandronate)."
Bloomberg News (7/22, Edney) reports the FDA "made the comments in an announcement today ahead of a meeting of agency advisers Sept. 9, where they will discuss the safety of the osteoporosis treatments." The FDA "is reviewing conflicting studies based on UK data that found no increased risk and a doubling in the risk of the throat cancer." Bloomberg News notes, "More than 40 million people either have osteoporosis in the US or are at high risk because of too low bone mass, according to the National Institutes of Health."
The NPR (7/21, Hensley) "Shots" blog reported, "A paper published in BMJ, the British Medical Journal, last year suggested the medicines could double the risk of such cancers." However, another paper that looked "at the same database," published in the Journal of the American Medical Association, "concluded there was no increased risk for either throat or stomach cancer."
Medscape (7/21, Lowes) reported that the FDA "stressed that it has not concluded that this class of medications increases the risk for esophageal cancer, and that it believes their ability to lower the risk for serious fractures in patients with osteoporosis outweighs their known potential risks." The agency is "advising physicians to instruct patients to carefully follow the directions for taking oral bisphosphonates, as esophagitis and other esophageal events have been reported for patients using the drugs incorrectly." Also, FDA is "telling physicians that there are not enough scientific data at this time to justify endoscopic screenings of patients who are taking oral bisphosphonates without any symptoms of esophageal problems." Reuters (7/22, Dey) also covers the story.
Reported by the American Association for Justice
Hail Creates Firestorm for State Farm
July 20, 2011
What began with an April 2006 hailstorm materialized into the most intense and significant litigation experience Indianapolis attorney Will Riley has had during his career.
Source: Indiana Lawyer
Seroquel label to carry new heart warning
July 18, 2011
The New York Times (7/19, Wilson, Subscription Publication) reports that "AstraZeneca is adding a new heart warning to the labels of Seroquel [quetiapine], its blockbuster antipsychotic drug, at the request of the Food and Drug Administration, company and agency officials said on Monday." The new "label, posted without fanfare last week on the FDA website, says Seroquel and extended-release Seroquel XR 'should be avoided' in combination with at least 12 other medicines linked to a heart arrhythmia" called prolongation of the QT interval. The revised "label also raises caution about use by the aged and people with heart disease."
Reported by the American Association for Justice
Judge blames Federal damage caps for inadequate award to Los Angeles train crash victims
July 15, 2011
The AP /New York Times (7/14, Subscription Publication) reported, "A judge on Thursday divided $200 million among victims of the disastrous 2008 collision of two trains but said he was forced to short-change them and make 'impossible decisions' because of a federal cap on damages." Victims of the Los Angeles collision between a Metrolink commuter train and a Union Pacific freighter were awarded damages according to their "degree of injury." Los Angeles Superior Court Judge Peter D. Lichtman said, "What was given to one victim had to be taken from another," and if the cases were tried separately, the verdict would've come close to or exceeded plaintiff attorneys' request for $320 million to $350 million. Metrolink and France-based Veolia Environment will pay the award. Veolia employed the engineer the National Transportation Safety Board found responsible for the crash.
Reported by the American Association for Justice
CPSC reduces acceptable lead levels for children's products
July 14, 2011
The Chicago Tribune (7/14, Gabler) reports the Consumer Product Safety Commission on Wednesday voted to decrease the amount of acceptable lead levels in children's products by two-thirds. The rule takes effect August 14 and says products "cannot contain more than 100 parts per million of lead." Commissioner Thomas Moore "said while the agency hasn't been able to quantify the benefits of reducing the limit from 300 parts per million to 100 parts per million, the scientific community has said there is no level of lead exposure to kids that has been deemed safe." Agency Chairman Inez Tenenbaum said "Consumers can rest assured that lead should be virtually nonexistent in toys and other children's products."
The AP (7/13) reported Republican commissioners, who dissented in the 3-2 vote said "the amount of allowable lead is already very low." Commissioners Anne Northup and Nancy Nord also said the commission "failed to undertake a solid review of whether all manufacturers, especially smaller domestic businesses, can make their products with the lower-lead level plastics, steel and other materials required as part of the new standard." Smaller companies "have said it could mean job cuts or failed companies because of increased testing costs, more expensive materials and products that may have to be cleared from store shelves and thrown away on Aug. 14."
Bloomberg News (7/13, Plungis) reported the vote "comes four years after the discovery of lead paint in toys from China that prompted legislation expanding the safety agency's powers." The 2008 Consumer Product Safety Improvement Act "required the agency to adopt the 100 parts per million limit for children's products unless it could establish it wasn't technologically possible for manufacturers to reach that level. Even some Democrats who voted for the tougher limits said Congress should have given the agency more flexibility to apply the standard only on new products, rather than on items already in store inventories."
Reported by the American Association for Justice
FDA issues warning on vaginal mesh implants
July 14, 2011
In a front page story, the Boston Globe (7/14, A1, Kotz, Weisman) reports, "Women who have vaginal surgery to fix a common gynecologic condition called pelvic organ prolapse may wind up with more problems than benefits if a plastic mesh is used, according to a safety communication issued yesterday by the Food and Drug Administration."
The Los Angeles Times (7/14, Mai-Duc) reports that the "FDA says a review of industry literature and patient reports has shown little evidence that the device improves pelvic organ prolapse, in which a woman's uterus, bladder or rectum can slip out of place."
The AP (7/13) reported, "About 75,000 women had prolapse surgery with mesh inserted through the vagina last year, and more than 200,000 women had the procedure for incontinence." Between 2008 and 2010 the FDA "received more than 1,500 reports of complications from women undergoing vaginal prolapse surgery with mesh, up 500 percent from the prior three years. There were fewer complications among incontinence patients." The FDA's "warning applies only to mesh for prolapse. The agency is also reviewing the use for incontinence, though side effects have not been as frequent."
The Minneapolis Star Tribune (7/14, Moore) reports, "The most-common complication is when the mesh becomes exposed or protrudes from the tissue, as well as pain, infection, bleeding and urinary problems. Three deaths have been associated with prolapse repair using mesh -- two bowel perforations and one hemorrhage, according to" the FDA. "Dr. William Maisel, the FDA's deputy director and chief scientist in the device division, said there are 'clear risks' associated with the mesh. 'The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed about potential complications.'"
HealthDay (7/13) reported, "The FDA plans to convene an independent panel of experts to meet and discuss the issue in early September. 'Input from the clinicians, manufacturers and other experts will help the FDA better understand the safety and effectiveness of surgical mesh for [pelvic organ prolapse and stress urinary incontinence] repair, including any changes that would improve our oversight,' Maisel said."
Reported by the American Association for Justice
Physicians may not be following heart-attack treatment guidelines
July 13, 2011
Bloomberg News (7/12, Cortez) reported that physicians "aren't following national guidelines for treating heart attack survivors, according to a study that found many receive an artery-clearing procedure even though previous research shows it offers no benefit." Investigators found that "the percentage of patients getting treatment didn't change after a 2006 trial dubbed OAT found it failed to reduce the risk of subsequent heart attacks, heart failure or death." And, "it didn't change after guidelines issued the next year by the American Heart Association and the American College of Cardiology said the procedure shouldn't be performed, according to the report" published in the Archives of Internal Medicine.
Reuters (7/12, Joelving) reported that the research adds to increasing worries about the potential overuse of stents.
HealthDay (7/11, Preidt) reported that investigators "analyzed data from 28,780 patient visits at 896 US hospitals between 2005 and 2008." Altogether, "PCI was performed on 11,083 patients before the OAT study was published, 7,838 between the release of the study and guideline changes, and 9,859 after the guidelines were revised, the investigators found." The researchers, after factoring "in other variables...found no overall significant decrease in the monthly rate of PCI performed for coronary blockages either after the OAT results were published or after the guidelines were updated."
Reported by the American Association for Justice
Lawsuits mounting over alleged health risks of Yaz contraceptive
July 12, 2011
The Star-Ledger (7/12, Todd) reports that "thousands" of plaintiffs "are alleging Bayer did not provide adequate warnings about the health risks associated with Yaz (drospirenone and ethinyl estradiol), and they are blaming the drug for causing blood clots, heart attacks, strokes and, in some cases, sudden deaths." Over "900 lawsuits have been filed in Bergen County - one of four courts where the mass tort litigation will be heard. Hundreds of other cases are filed in courts in Philadelphia, California and Illinois." When Yaz and its predecessor, Yasmin (estrogen ethinyl estradiol and drospirenone), "were approved by regulators, the pills were considered an advance over older forms of oral contraceptives because they were taken for 24 days rather than the usual 21, which was believed to benefit women because it created less hormonal fluctuation. But early on, there were concerns about the health risks associated with drospirenone."
Reported by the American Association for Justice
Summer spike in medical errors may be a real phenomenon
July 12, 2011
The New York Times (7/12, D6, Rabin, Subscription Publication) reports in "Vital Signs," that "until recently there was little proof that medical errors spike in the summer when new medical trainees start working at teaching hospitals - a phenomenon known as the 'July effect.' But a new review has found evidence that death rates do increase in July, and that many patients stay in the hospital longer than in other months."
The Wall Street Journal (7/11, Hobson) "Health Blog" reported that for the review, published in the Annals of Internal Medicine, investigators looked at data from 39 different studies.
The Boston Globe (7/11, Kotz) "Daily Dose" blog reported that "the best-quality studies reviewed found that patients treated in July had a four to 12 percent increase in mortality risk compared to those treated in the spring before the staffing change." Meanwhile, "Some of the studies also indicated an increase in medical errors and complications from procedures, but the data weren't strong enough to draw firm conclusions."
Reported by the American Association for Justice
Former Contractor Victorious After State Farm Legal Defeat
July 8, 2011
Source: The Indy Channel
Attorneys lining up to pursue J&J in lawsuits over hip joints
July 8, 2011
Under the headline "Hip Joints Set Off New Rush To Court," the Wall Street Journal (7/8, Rockoff, Searcey, Subscription Publication) says attorneys are lining up to sue Johnson & Johnson over its DePuy Orthopaedics Inc. metal-on-metal hip joins. The company stopped manufacturing them in 2009, and later recalled them, but it is fighting the lawsuits and charges in them. Some 1,000 already have been filed in both federal and state courts. The Journal says that by some estimates the company could face $1 billion or more in litigation- related costs. Some of the cases have been consolidated in federal court in Ohio, and some plaintiff attorneys are pushing for class-status for the suits.
Reported by the American Association for Justice
FDA releases graphic smoking warning labels
July 6, 2011
American Medical News (7/4, Moyer) reported that the FDA released "nine text and graphic image health warnings that must appear on all cigarette packs, cartons and advertisements by September 2012," including "images of a man smoking through a tracheotomy hole and a dead man with a surgery-scarred chest." Philip Morris protested, arguing that the government would be compelling a private company to advertise a message that it did not choose, which they argue violates the First Amendment. Health and Human Services Secretary Kathleen Sebelius said, "These labels are frank, honest and powerful depictions of the health risks of smoking, and they will help encourage smokers to quit and prevent children from smoking."
Reported by the American Association for Justice
Chantix linked to increased risk of heart attack, stroke
July 5, 2011
A study linking use of the drug Chantix (varenicline) to increased heart risks garnered significant news coverage, with two networks carrying reports on their respective nightly news programs. The CBS Evening News (7/4, lead story, 3:00, Pelley) reported that research "raises new safety questions about" Chantix (varenicline). NBC Nightly News (7/4, story 9, 0:30, Snow) reported that a study published in the Canadian Medical Association Journal suggests that "patients who take Chantix are increasing their risk of heart problems including heart attacks and strokes, even if they have no prior history of heart disease." The New York Times (7/5, B3, Wilson, Subscription Publication) reports that the "study...compiled data from 14 random, blinded, placebo-controlled clinical trials that tracked cardiovascular outcomes." Researchers "found 52 out of 4,908 people taking Chantix had serious cardiovascular events, a rate of 1.06 percent, compared with 27 out of 3,308 people taking a placebo, a rate of 0.82 percent. While the absolute difference is only 0.24 percent, the weighted, relative difference is 72 percent." The Wall Street Journal (7/5, Burton, Subscription Publication) reports the research comes just a month after the FDA warned that Chantix may be linked to increased risk of cardiovascular problems in individuals with heart disease. Bloomberg News (7/5, Randall) reports that the FDA "warned in 2009 that the medicine may increase suicides and erratic behavior." The FDA "is examining the" new "study and may consider new warnings, Curtis Rosenbraugh, director of the agency's office of drug evaluation, said in an interview." The Baltimore Sun (7/5) reports that FDA officials "have...asked the drug's maker, Pfizer, to conduct another review and to plan its own study." The agency "also has asked Pfizer to conduct a large, randomized study of possible psychiatric effects."
Reported by the American Association for Justice
Antidepressant use during pregnancy associated with increased risk of autism
July 5, 2011
The Wall Street Journal (7/5, D3, Wang, Subscription Publication) reports that expectant mothers who take antidepressant medication during their pregnancy may have an increased risk of giving birth to a child with autism, according to a study published online July 4 in the Archives of General Psychiatry. CNN /Health.com (7/5, Harding) reports that children exposed to selective serotonin reuptake inhibitors (SSRIs) "during the first trimester were nearly four times as likely to develop an autism spectrum disorder (ASD), compared with unexposed children, according to the study" of 298 youngsters with an ASD and 1,507 youngsters without an ASD identified from the Kaiser Permanente patient database. After adjusting for confounding factors, "the researchers found that any exposure to the drugs in the womb increased the risk of ASD diagnosis 2.2-fold, while first-trimester exposure increased the risk 3.8-fold." On its website, ABC News (7/4, Carollo) reported, "that risk was even four times higher in women who took SSRIs during their first trimester." However, "though these numbers may seem alarming, the authors warn that they shouldn't be over- interpreted." ABC News added, "in the general population, they wrote, 'the fraction of cases of ASD that may be attributed to use of antidepressants by the mother during pregnancy is less than three percent...and it is reasonable to conclude that prenatal SSRI exposure is very unlikely to be a major risk factor for ASD.'" HealthDay (7/4, Goodwin) reported, "though the risks and benefits taking any medication during pregnancy should be carefully considered, Dr. Natalie Meirowitz, chief of the division of maternal fetal medicine at Long Island Jewish Medical Center in New Hyde Park, advised expectant mothers who suffer from depression not to toss their medications." This is "because depression itself poses a risk to mother and baby. Depressed women may self-medicate with drugs and alcohol, fail to eat right and keep their prenatal appointments, and be unable to care for their baby after delivery, Meirowitz said." Reuters (7/5, Steenhuysen) Reuters (7/5, Steenhuysen) quotes Thomas Insel, MD, director of the National Institute of Mental Health, as saying in a telephone interview, "there are real risks to not being treated for a serious illness like depression. You have to weigh the options." He added, "a threefold increase in risk is not insignificant. It is worth taking that into account with other factors."
Reported by the American Association for Justice
Government releases graphic warning labels for cigarettes sold in US
June 22, 2011
The announcement Tuesday of new graphic warning labels for cigarettes sold in the US is gaining widespread media attention, including reports on two evening network newscasts, much of it highlighting statements from Secretary Sebelius touting them as "frank, honest and powerful depictions of the health risks of smoking." Appearing on the CBS Early Show (6/21, 7:35 a.m. EDT), Secretary Sebelius said the effort "is really aimed at making sure kids don't start in the first place. ... But also, to make sure that adults who want to stop, we give them some help. So the graphic warnings also contain 1-800-QUIT number to make a case to adults that it's never too late to stop smoking." In a report preceding the Sebelius interview, CBS (6/21, 7:33 a.m. EDT) reported, "For decades, a written warning was required on cigarette packaging. But anti-smoking advocates say the new warnings are long overdue, and will help target the most vulnerable: the young and uneducated." FDA Commissioner Margaret Hamburg was shown on NBC Nightly News (6/21, story 3, 2:30, Williams) saying, "Kids who are under the impression that smoking is cool or glamorous will be confronted by a very different reality." The CBS Evening News (6/21, story 8, 135, Pelley) reported that the labels' "graphic images of rotting teeth, damaged lungs, and even a smoker's corpse, shocked the longtime smokers we showed them to, like Michael Magistro."
In an article published in some form by hundreds of sources, the AP (6/22, Felberbaum) reports that with a decline in the US smoking rate having "come to a standstill, the government is hoping the in-your-face labels will go further than the current surgeon general warnings toward curbing tobacco use, which is responsible for about 443,000 deaths a year in the US." The AP adds that the new warnings were "required in a 2009 law that, for the first time, gave the federal government authority to regulate tobacco. Tuesday's announcement follows reviews of scientific literature, public comments and results from an FDA-contracted study of 36 labels proposed last November."
The Hill (6/22, Pecquet) "Healthwatch" blog highlights the support expressed for the new warnings by a number of public health groups, including the American Heart Association, which said in a statement that "warnings represent an aggressive and welcome approach to reducing smoking rates that have leveled off in recent years as tobacco companies continue to launch campaigns to entice new smokers and maintain current customers."
Also highlighting praise from health advocacy groups, the New York Times (6/22, B1, Wilson, Subscription Publication) adds that "the four leading tobacco companies were all threatening legal action, saying the images would unfairly hurt their property and free-speech rights by obscuring their brand names in retail displays, demonizing the companies and stigmatizing smokers. The government won one case last year in a federal court in Kentucky on its overall ability to require larger warning labels with images; the specific images released Tuesday are likely to stir further legal action."
National Journal (6/22, Brownstein, Subscription Publication) notes that "Sebelius said that FDA can change the pictures to keep them freshly horrifying. 'So, immediately after the launch of the first set of nine, we'll begin the studies to make sure that we are keeping people sensitized, and we have the authority then to move to a new set of labels,' she said."
Asked on NPR's All Things Considered (6/21) about the warnings that are being replaced, Hamburg said, "Various studies showed that they had lost their power and effect. And these warning labels are going to be quite different. For one thing, they're going to be much larger and more prominent, taking up half of the cigarette pack. And they will be in bold color with clear statements with respect to the health risks." On its "The Oval" blog, USA Today (6/22, Jackson) quotes Hamburg saying that the new warnings will mark a "dramatic difference in what cigarette packages look like."
CNN (6/22, Young) reports on its website that Sebelius said "a stall in the downward trend of smoking in America, particularly among young people, prompted President Barack Obama to renew the focus on getting Americans to kick the habit or never start smoking in the first place. It is the first government-mandated label change for cigarettes in 25 years, she said, adding that a major motivation was targeting young people from wanting to smoke."
CQ Healthbeat (6/22, Adams, Bunis, Subscription Publication) quotes Sebelius saying that the warnings "will encourage smokers to quit, and prevent children from smoking. President Obama wants to make tobacco-related death and disease part of the nation's past, and not our future." CQ adds that tobacco companies including Philip Morris USA Inc. have questioned the constitutionality of the warnings.
Bloomberg News (6/22, Peterson) reports "the FDA estimates the labels will reduce the number of US smokers by 213,000 people in 2013, Lawrence Deyton, director of the agency's Center for Tobacco Products, said today at a news conference at the White House."
The Wall Street Journal (6/22, McKay, Kesmodel, Subscription Publication) reports that how effective the labels will be is unknown, but more than a quarter of survey respondents in 13 of 14 countries said in a recent survey that similar warnings made them consider quitting, according to the CDC.
In a Marketplace Public Radio (6/21) report on the new warnings, HHS Deputy Secretary Bill Corr was heard saying, "Despite the many health risks that are now well known, youth and adult smoking rates that had been dropping have stalled." Corr and assistant secretary Howard Koh told New England Cable News (6/22) that "the nine images were selected after a year-long review because they are seen as carrying the strongest message encouraging adults to quit and discouraging teenagers from taking up the habit. Corr said the experience of nearly 30 other countries with similar labels show they can have a significant impact reducing smoking rates."
Prevalence of graphic warnings in other countries highlighted. The AP (6/21, Gibson) adds that "more than 40 countries around the world already require warnings as graphic as the new US labels -- if not more so." While noting that "it's impossible to attribute reduced smoking rates to any single cause," it adds that public health officials in Canada, Brazil, Thailand and elsewhere claim that graphic images required there have helped reduce smoking.
Reported by the American Association for Justice
AMA issues 2011 report card on commercial health insurers
June 21, 2011
The AP (6/21) reports that the American Medical Association (AMA), "the nation's largest doctors' group, says about one in five payments of medical claims by commercial health insurers is inaccurate, shortchanging physicians." Yesterday, the AMA "released its annual report card on insurers," saying that "eliminating mistakes would save doctors and insurers $17 billion a year."
"The AMA said commercial health insurance companies have an error rate of 19.3 percent, up two percentage points from last year's report," the Chicago Tribune (6/21, Japsen) reports. "Improving claims processing could save patients money and improve medical care by reducing hassles physicians have when they are forced to haggle with health plans over payments or other issues. The AMA said the report is designed to hold insurance companies accountable."
Modern Healthcare (6/20, Zigmond, Subscription Publication) reported, "The 2011 report card is based on a random sampling of about 2.4 million electronic claims for approximately four million medical services submitted in February and March 2011 to Aetna, Anthem Blue Cross Blue Shield, Cigna, Health Care Service Corp., Humana, the Regence Group, UnitedHealthcare and, for comparison, Medicare, according to the AMA. The claims were gathered from more than 400 physician practice groups in 80 medical specialties in 42 states." Commenting on the 2011 report card, "Robert Zirkelbach, spokesman for America's Health Insurance Plans, said in an e-mailed response that insurers and providers share the responsibility of improving claims payment accuracy and efficiency."
Healthcare IT News (6/20) reported, "Dramatic reductions in denial rates have occurred since last year at Aetna, Anthem Blue Cross Blue Shield, Health Care Service Corporation and UnitedHealthcare, which cut its denial rate by half to 1.05 percent." Again, "CIGNA maintained its industry leading low denial rate of 68 percent." Notably, "lack of patient eligibility for medical services continues to be the most frequent reason for denials."
Reported by the American Association for Justice
Sebelius, CMS officials announce technology to fight Medicare, Medicaid fraud
June 18, 2011
The Philadelphia Inquirer (6/18, Sell) reported Secretary Sebelius joined Center for Medicare and Medicaid Services leaders Friday in Philadelphia to discuss a system coming July 1 that "is supposed to enable the government to collect and analyze information so it can spot potential" Medicare and Medicaid "fraud rather than simply evaluate one claim at a time." It "will use technology similar to that used by banking and telecommunications companies to spot fraud." Sebelius said at Friday's news conference that officials "wanted to be able to spot the doctor claiming to be in six cities billing for the same procedure on the 16th of June."
CQ HealthBeat (6/18, Adams, Subscription Publication) reported Friday's announcement came as Secretary Sebelius "and Attorney General Eric H. Holder Jr. were holding an anti-fraud summit in Philadelphia, the fifth in a series of meetings that they have held over the past year and a half. The Northrop Grumman predictive modeling tool will assign risk scores to claims and alert CMS officials to those that seem unusual because they differ from patterns."
The AP (6/17, Alonso-Zaldivar) reports that, up to now, Medicare "has basically paid claims first and asked questions later in a system dubbed 'pay and chase.' The technology upgrade should help deter flagrant abuses."
Reported by the American Association for Justice
COPD mist inhaler may increase risk for early death
June 16, 2011
Bloomberg News (6/15, Doherty) reported, "Boehringer Ingelheim GmbH and Pfizer Inc. (PFE)'s Spiriva mist inhaler" for chronic obstructive pulmonary disease (COPD) may "raise the risk of an early death," according to a review of five studies published in the British Medical Journal. Although the Food and Drug Administration "last year said a two- year review didn't indicate Spiriva increased the risk of heart attack and stroke," earlier studies had "suggested a potential risk."
HealthDay (6/14, Preidt) reported that the five studies analyzed by Dr. Sonal Singh, an assistant professor of general internal medicine at the Johns Hopkins University School of Medicine, and colleagues included "more than 6,500 patients." The researchers "compared the mist inhaler with Spiriva against a mist inhaler with a placebo." They found that patients who used the inhaler with Spiriva were "52 percent more likely to die than those who used the inhaler with the placebo."
Reported by the American Association for Justice
Diabetes treatment may raise bladder cancer risk, FDA warns
June 16, 2011
The Wall Street Journal (6/16, Dooren, Subscription Publication) reports the Food and Drug Administration said the use of Takeda Pharmaceutical's diabetes drug Actos (pioglitazone hydrochloride) for more than one year might increase the risk of bladder cancer.
Bloomberg News (6/16, Peterson) reports, "A five-year interim analysis of data from a decade-long company- sponsored study showed a greater likelihood of bladder cancer in patients who took the drug for the longest periods of time, and at the highest cumulative doses," the FDA said in a safety announcement, which "updated preliminary findings released nine months ago." The FDA "had said Sept. 17 that while it hadn't found a statistically significant link between Actos and bladder cancer, the risk appeared to be higher in patients who took the drug for the longest duration, and at the highest cumulative doses." According to the announcement, the median duration of therapy was 24 months for patients treated with the drug. "Treatment times ranged from 2.4 months to 8.5 years."
Reported by the American Association for Justice
Lawsuit provides inside look at drug marketing
June 14, 2011
McClatchy (6/13, Adams) reported on Solvay Pharmaceuticals' push for off-label sales of testosterone replacement drug AndroGel. In 2000, when the Food and Drug Administration approved it to treat AndroGel hypogonadism, the company announced that the "market was 'four to five million American men.' But by 2003, when drug was being pushed by its corporate managers, the number drifted to 'up to 20 million men,'" according to information in a whistleblowers lawsuit "recently unsealed by a federal court in Texas." The current whistleblower lawsuit actually involves "three of Solvay's drugs -- AndroGel, a blood pressure drug, and a mental health drug -- and provides an inside look at the world of corporate drug marketing." Dozens of internal company documents, "emails and sales presentations were filed in the case, documenting how the company and its sales representatives sweet-talked, cajoled and even paid fees to the doctors in their territories."
Reported by the American Association for Justice
Long-term, heavy cell phone use may raise risk of brain tumors slightly
June 13, 2011
In continuing coverage, HealthDay (6/10, Reinberg) reported that the debate over whether "cell phones might cause brain tumors continues, as a new international study finds a small risk among people who are heavy cell phone users or who have used them for a long time." For the new study, which was published in the June 10 online edition of Occupational and Environmental Medicine, researchers collected data on "1,229 people with brain tumors and 3,673 people without brain tumors." They found that a higher risk of "developing a glioma among those who used their cell phones for 10 years or more." However, even with these potential "increased risks, the incidence of brain tumors is fairly rare. 'Brain tumor incidence rates have been flat to slightly declining over the last 20 years,'" said Dr. Otis Brawley from the American Cancer Society, who "was not involved with the latest research."
Reported by the American Association for Justice
Updated government carcinogens report links two common chemicals with cancer risk
June 13, 2011
On its website, ABC News(6/10, Murray) reported that HHS added "eight more substances to its 'known human carcinogen' or 'reasonably anticipated to be carcinogen' lists today, one week after a World Health Organization study concluded that cell phones may cause cancer." The Los Angeles Times (6/10, Dennis) "Booster Shots" blog reported that formaldehyde "now officially falls into the 'known to be a human carcinogen' category," and styrene can now "officially be described as 'reasonably anticipated' to be cancer-causing," according to the Department of Health and Human Services' updated " Report on Carcinogens." Carcinogens used in everyday products. In a front-page story, the New York Times (6/13, A1, Harris, Subscription Publication) reports that the federal government on Friday issued warnings about the "two materials used daily by millions of Americans." The report by NIH's National Toxicology Program found evidence that styrene, which is used in "boats, bathtubs, and in disposable foam plastic cups and plates," may increase the risks of "cancer of the pancreas and esophagus," the report found. Consumers can be exposed to styrene from the "fumes of building materials, photocopiers and tobacco smoke." According to the AP (6/11), NIH says the greatest exposure to styrene is "through cigarette smoking." The Time (6/10, Walsh) "Healthland" explained that the report found that "concerning amounts of formaldehyde could be encountered in plywood and particle boards, as well as in hair salons and in mortuaries," and the exposure is "most intense" among workers in "some manufacturing plants." With formaldehyde and styrene, the government also added captafol, cobalt-tungsten carbide, "certain inhalable glass wool fibers, o-nitrotoluene," and riddelliine to its twelfth report, bringing the total to 240 carcinogens. Notably, studies of mortuary workers "exposed to high levels of formaldehyde have shown increased incidences of certain kinds of rare nasal cancers." The New York Daily News (6/10) noted that the report also linked formaldehyde to leukemia. The American Cancer Society "said consumers should not worry about cups or food containers, but should shelve personal products with formaldehyde." The Washington Post (6/11, Stein) noted that most of the cancer risk evidence "came from people exposed to relatively high levels in industrial settings. 'A listing...does not by itself mean that a substance will cause cancer,'" saidDr. John Bucher, associate director of the National Toxicology Program. Moreover, Dr. Bucher said the updated listings "do not trigger any immediate new restrictions on the substances, but other government agencies may use the information in the future as part of their regulatory decisions." He said individuals can use the list to "make personal choices," noting that most people's "routine exposure to the newly listed substances was probably low." Bloomberg News (6/10, Young) pointed out that aristolochic acids, which are "found in herbal products used to treat arthritis and gout," were also listed as carcinogens, because they "can cause bladder or urinary-tract cancer in people with kidney disease." Meanwhile, American Chemistry Council CEO Cal Dooley released a statement saying the report "makes 'unfounded classifications' about formaldehyde and styrene that will scare consumers," and the American Composite Manufacturers Association disputed the styrene and cancer link with a statement saying, "styrene-based composite material system has been used safely for over 60 years."
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Many heart failure patients may not receive recommended therapies
June 7, 2011
The National Journal (6/2, Fox, Subscription Publication) reports, "Medicaid will no longer pay hospitals or doctors for certain preventable illnesses and injuries, such as operating on the wrong body part, the Health and Human Services Department said Wednesday." In a statement, Donald Berwick, administrator of the Centers for Medicare and Medicaid Services, said, "These steps will encourage health professionals and hospitals to reduce preventable infections, and eliminate serious medical errors." The Journal points out that Medicare "already has such a policy -- one widely recommended by health care experts as a way to help prevent expensive and deadly errors." "Now this concept will be extended to Medicaid," CQ (6/2, Norman, Subscription Publication) reports. "Under the healthcare law (PL 111-148, PL 111-152), the curb on payments for preventable conditions must also apply to Medicaid." In other words, "states won't be allowed to pay providers including hospitals, doctors and other health care organizations if patients develop conditions that are deemed reasonably preventable." Kaiser Health News (6/1, Galewitz) reported, "Currently, about 21 states have such a nonpayment policy," but "the 2010 federal health law, in effect, expands the ban nationwide. The rule published [yesterday] gives states until July 2012 to implement it." However, some medical groups have reservations about this policy. Kaiser Health News quoted written comments made by Michael Maves, MD, CEO of the American Medical Association, to the CMS three months ago. Maves wrote, "Simply not paying for complications or conditions, that, while extremely regrettable, are not entirely preventable, is a blunt approach that is not effective or wise for patients or the Medicare or Medicaid program." Writing in the Forbes (6/1) "Health Dollars" blog, David Whelan focused on possible unintended consequences of the new rule proposed by the CMS that "would modify the Inpatient Prospective Payment System." Whelan pointed out that "the new payment plan assumes that changing a whole industry is as simple as turning a few knobs and pushing a few buttons on the Medicare dashboard. Implementing such a scheme will be extremely difficult, possibly unfair and will most definitely increase the cost of health care rather than save money." Whelan contended that Medicare currently does not have the necessary experience to make clinical judgments affecting patients. He also voiced concern that hospital systems would have to merge as a result of the proposed rule, thereby setting up "powerful health care oligarchies." At least 34 patients died as a result of preventable mistakes in Oregon hospitals in 2010. The Oregonian (6/2, Rojas-Burke) reports, "At least 34 patients died as a result of preventable mistakes in Oregon hospitals last year, the same number reported in 2009 to the Oregon Patient Safety Commission." Although "the number is small in comparison to the tens of thousands of people safely restored to health in hospitals each year, it is one of several indicators of stalled progress in reducing serious medical errors.
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International panel of experts categorizes cell phones as "possibly carcinogenic"
June 1, 2011
ABC World News (5/31, lead story, 3:10, Sawyer) reported, "An important new alert about the safety of cell phones and the possible risk of cancer, brain cancer in particular...comes from the World Health Organization." NBC Nightly News (5/31, lead story, 3:10, Williams) reported, the WHO "statement labeling cell phones as a possible carcinogenic hazard comes from a panel of 31 scientists." According to the AP (6/1, Cheng), the statement was "issued in Lyon, France, on Tuesday by the International Agency for Research on Cancer" (IARC) after a "weeklong meeting" during which experts reviewed "possible links between cancer and the type of electromagnetic radiation found in cellphones, microwaves and radar." The IARC classified cellphones in "category 2B, meaning they are possibly carcinogenic" to humans. The assessment now "goes to WHO and national health agencies for possible guidance on cellphone use." The Wall Street Journal (6/1, Martin, Hobson, Subscription Publication) reports that the IARC working group did not conduct new research. Instead, the panel reviewed existing literature that focused on the health effects of radio frequency magnetic fields. Its findings are slated to be published July 1 in Lancet Oncology. The New York Times (5/31, Parker-Pope, Barringer, Subscription Publication) "Well" blog noted that the panel's decision to "classify cellphones as 'possibly carcinogenic' was based largely on epidemiological data showing an increased risk among heavy cellphone users of a rare type of brain tumor called a glioma." Most "major medical groups," including the National Cancer Institute, have "said the existing data on cellphones and health has been reassuring." Earlier this year, the Journal of the American Medical Association "reported on research from the National Institutes of Health, which found that less than an hour of cellphone use can speed up brain activity in the area closest to the phone antenna." The Los Angeles Times (6/1, Roan, Gabler) reports that a 2010 study (pdf) published in the International Journal of Epidemiology found a "40% increase risk of gliomas for people who used a cellphone an average of 30 minutes a day over a 10-year period." The Orange County (CA) Register (5/31, Brennan) reported that the literature review also indicated "long-term or heavier use" of cell phones may increase risk for a "cancer type called acoustic neuroma." Bloomberg News (5/31, Kresge) reported that the most recent research "considered dated to 2004, and exposure levels from handsets have dropped over time," said IARC Working Group Chair Dr. Jonathan Samet from the University of Southern California. The age of the studies also means the participants "had used their phones for no more than 10 to 15 years, leaving open the question of the effect of longer-term exposure," he noted. On the CBS Evening News (5/31, lead story, 2:50, Smith), Dr. Samet was shown saying, "The jury is not clear, it's not an established carcinogen and for those who want to take steps to reduce their exposure, they can do it." BBC News (6/1, Gallagher) reports, "Ed Yong, head of health information at Cancer Research UK, said: 'The WHO's verdict means that there is some evidence linking mobile phones to cancer but it is too weak" to draw strong conclusions. WebMD (5/31, DeNoon) reported that the finding "means that research is urgently needed. ... It's important to put the possible risk into context. Kurt Straif, MD, PhD, MPH, head of the IARC Monographs Program," noted that the IARC currently lists "some 240 agents as 'possibly carcinogenic,' including dry cleaning fluid and some commonly used pesticides." Utah's Deseret Morning News (5/31, Hicken) quoted IARC Director Christopher Wild as saying, pending the availability of long-term research, "it is important to take pragmatic measures to reduce exposure such as hands-free devices or texting." CNN (5/31, Dellorto) noted that manufacturers of "many popular cell phones already warn consumers to keep their device away from their body and medical experts say there other ways to minimize" cell phone radiation. For example, the Apple iPhone 4 "safety manual says users' radiation exposure should not exceed FCC guidelines: 'When using iPhone near your body for voice calls or for wireless data transmission over a cellular network, keep iPhone at least 15 millimeters (5/8 inch) away from the body.'" Meanwhile, the National Journal (6/1, Brownstein, Subscription Publication) reports that the American Cancer Society estimates that "around 22,000 Americans will be diagnosed with malignant tumors of the brain or spinal cord and 13,070 will die. Gliomas account for about 1.3 percent of all cancers in the US." HealthDay (5/31) noted that globally, an estimated "five billion cell phones are in use. 'The number of users is large and growing, particularly among young adults and children,'" the IARC said in a news release.
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Administration's patient safety initiative lauded
May 31, 2011
American Medical News (5/30) editorialized, "The federal government's new Partnership for Patients initiative," unveiled by the Department of Health and Human Services last month, "has all the markings of becoming a landmark event in the patient safety movement." It "aims to cut preventable hospital- acquired conditions 40% by 2013, translating into 1.8 million fewer injuries to patients. During the same period, it hopes to reduce unnecessary returns to the hospital by 20%, preventing more than 1.6 readmissions." Notably, the "American Medical Association is among" the more than 1,600 groups and hospitals that have pledged to support the initiative. Hospitals under increased pressure to reduce preventable infection rates. On its "Weekend Edition Saturday" program, NPR (5/28, Varney) reported that although it has been "more than a decade since a panel of top scientists declared hospital safety" as a national priority, about "90,000 patients still die each year from preventable infections resulting from routine surgeries and hospital care," according to the Centers for Disease Control and Prevention. However, under legislation in more than "two dozen states and new Medicare rules that went into effect earlier this year," hospitals are now required to report infections "or pay a penalty. That's left hospital administrators weighing the cost of 'fessing up against the cost of fines."
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Atlanta hospital worker exposed nearly 700 patients, 100 employees to TB
May 31, 2011
CNN (5/27) reported that nearly "700 patients at Emory University Hospital in Atlanta have been exposed to tuberculosis after coming in contact with a hospital employee carrying the disease," hospital spokesperson Lance Skelly said Thursday. He said the Georgia Department of Community Health and the hospital have "identified 680 patients who were exposed to tuberculosis between November and February." The Atlanta Journal-Constitution (5/28, Williams) noted that an "additional 100" hospital employees were also "exposed by a respiratory technician who unknowingly carried the disease." The worker, who had a "persistent cough for weeks, was diagnosed April 17," according to Skelly.
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Approval of genetically modified crops may raise consumers' concerns
May 25, 2011
The Chicago Tribune (5/25, Eng) reports, "With an unprecedented number of genetically modified crops being greenlighted by the Obama administration in recent months...some advocates say the issues may be reaching the awareness of consumers" Meanwhile, although "the Food and Drug Administration has allowed the sale and planting of genetically modified foods for 15 years, it has never required premarket safety evaluations of the foods." Consumers union calls for labeling GM foods. In the Huffington Post (5/25), Jean Halloran, Director of Food Policy Initiatives at Consumers Union, writes, "The FDA is deliberating whether or not it will approve, for the first time, genetically engineered (GE) animals into the food supply, labeled or not." Halloran predicts it is likely the FDA "will approve the raising and selling of GE salmon--without labeling--in the very near future," but Consumers Union, opposes this "on the grounds that the agency's safety assessment was woefully inadequate." According to the advocate, "FDA allowed Aquabounty, the company developing the GE salmon, to declare that there was no increase in allergy-causing potential based on data from exactly six engineered fish--even when the data from those fish suggested there might be a problem." Halloran calls for genetically engineered food to be labeled so consumers can "know what they are eating and...decide for themselves what to put on their plates."
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FDA warns against adding thickening agent to breast milk, formula given to premature babies
May 24, 2011
The AP (5/21) reported, "The Food and Drug Administration is warning parents and healthcare providers to stop using the SimplyThick additive in the breast milk and formula of premature babies after the deaths of two infants who were given it." The FDA "said the product, a thickening agent that helps infants with swallowing, may cause a potentially life-threatening intestinal disorder," necrotizing enterocolitis. The Los Angeles Times (5/20, Maugh) "Booster Shots" reported that the FDA "said it has recently received 15 reports of infants who received the product developing necrotizing enterocolitis, with two deaths." Symptoms of the disorder include the appearance of a "bloated abdominal area, the appearance of illness, feeding intolerance, greenish-tinged vomiting and bloody stools." Premature infants "still in the hospital and those who have been discharged within the past 30 days should not be given SimplyThick," the agency said.
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Reports link erectile dysfunction drugs to hearing loss
May 20, 2011
The UK's Telegraph (5/19, Bloxham) reported, "Viagra (sildenafil) and similar impotence drugs have been linked to hundreds of cases of sudden hearing loss around the world, including some in the" United Kingdom. "Forty-seven suspected cases of sensorineural hearing loss – a rapid loss of hearing in one or both ears – were linked to Viagra and related" medications Cialis (tadalafil) and Levitra (vardenafil). "The researchers are not sure how Viagra might affect hearing, but it may be that the chain of chemical reactions it triggers have knock-on effects in the inner ear."
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Consumer group petitions FDA to remove higher-dose donepezil from the US market
May 20, 2011
Bloomberg News (5/18, Edney) reported that on May 18, the consumer group "Public Citizen of Washington petitioned the Food and Drug Administration today to remove the 23 milligram dose of Aricept [donepezil, sold by Pfizer, Inc. and Eisai Co.] to treat moderate to severe Alzheimer's from the US market." The group maintains that "higher doses" of the medicine "endanger patients and don't enhance the treatment's effectiveness." According to the US National Institutes of Health, "as many as 5.1 million Americans may have Alzheimer's, the most common form of dementia in older people." The Los Angeles Times (5/18, Maugh) "Booster Shots" reported, "Aricept has been approved by the FDA in dosages of 5 to 10 milligrams for patients with mild to moderate cases of Alzheimer's and in a dose of 10 to 23 milligrams for more severe cases." However, "the petition asks the FDA to ban the 23- mg version of the drug and to warn patients and physicians against taking two 10-mg. pills per day if the higher dosage is removed from the market." The petition explained that "clinical trials of Aricept submitted to the FDA for approval show no significant benefit from the 23-mg version compared to the 10-mg version." The CNN (5/18, Park) "The Chart" blog reported, "The group says that the drug in higher dose compared with the 10-milligrams could pose increased adverse effects, such as slowed pulse rate, nausea, vomiting, diarrhea, urinary incontinence, fatigue, dizziness and agitation." Vomiting can be particularly problematic for Alzheimer's patients, "because it can lead to other problems such as pneumonia, massive gastrointestinal bleeding, esophageal rupture and even death, the group said."
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Congress urged to amend law to preserve consumers' ability to bring class-action lawsuits
May 17, 2011
A Los Angeles Times (5/17) editorial urges Congress to amend the Federal Arbitration Act to authorize states to "declare some arbitration agreements unconscionable." The Times says the US Supreme Court narrowly interpreted the act in refusing class-action status to Vincent and Liza Concepcion's small-claims grievance against AT&T. The Federal Arbitration Act permits state law to trump the enforcement of arbitration agreements, but the justices determined the "exception didn't apply ... because breaking their contract with AT&T would frustrate the purpose of the arbitration act." The Time says the ruling "has made it harder for groups of consumers or employees to band together to seek damages from corporations."
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Feds to seek $1 billion from J&J in off-label marketing probe, unnamed sources say
May 13, 2011
The Wall Street Journal (5/13, Rockoff, Lublin, Subscription Publication) reports that according to unnamed sources who are familiar with the issue, federal prosecutors are planning to solicit $1 billion to settle an investigation of a Johnson & Johnson unit's marketing practices. According to Securities and Exchange Commission filings, for the past six-years, the government has conducting a probe into whether J&J's Janssen Pharmaceutica unit promoted the antipsychotic Risperdal (risperidone) for unapproved, off- label uses. When asked about the possible settlement, according to the Journal, J&J spokespeople said it was inappropriate to speculate. However, the sources say J&J officials were shocked at the sum. Prosecutors apparently used a 2009 settlement in which Eli Lilly paid $1.4 billion to resolve similar allegations regarding its antipsychotic Zyprexa (olanzapine) as a benchmark. Reuters (5/13, Pierson) notes that in its latest SEC filing May 9, J&J noted that to avoid facing civil and criminal proceedings, the company has reserved an unspecified amount of money for a potential settlement.
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Nearly one in seven elderly nursing home residents being given atypical antipsychotics, audit shows
May 12, 2011
The New York Times (5/10, Subscription Publication) "The New Old Age" blog reported that "nearly one in seven elderly nursing home residents, almost all of them with dementia, are given powerful atypical antipsychotic drugs, even though the medicines increase the risk of death and are not approved for such treatments, a government audit found." Notably, "in response to the audit, the Centers for Medicare and Medicaid Services said that some of the inappropriate use of antipsychotics in elderly nursing home patients is a result of drug makers' paying kickbacks to nursing homes to increase prescriptions for the medicines." The Huffington Post (5/10, Baram) "The Watchdog" blog reported that in a statement, Health and Human Services Inspector General Daniel R. Levinson "noted the complicity of drug companies in this dangerous practice." Levinson wrote, "Despite the fact that it is potentially lethal to prescribe antipsychotics to patients with dementia, there's ample evidence that some drug companies aggressively marketed their products towards such populations, putting profits before safety.... The report didn't explore this issue, but a series of lawsuits and settlements that DHHS helped bring about suggest that many pharmaceutical companies have improperly promoted these drugs to doctors and nursing homes for many years."
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Sebelius, hospital CEO tout benefits of patient safety initiative
May 6, 2011
HHS Secretary Katheleen Sebelius and Charles J. Barnett, president/CEO of Seton Family of Hospitals, write in an op-ed for the Austin American Statesman (5/6), "There is no doubt that America has the world's most skilled doctors and nurses and the finest hospitals," yet a new "study found that nearly one out of three hospital patients is harmed by the care they receive." As a result, "the Obama administration has joined with the Seton Family and more than 1,200 other hospitals nationwide, along with hundreds of employers, health insurers, provider organizations, and patient advocates, to launch the Partnership for Patients, an unprecedented alliance that will promote innovations to improve hospital care and reduce wasteful spending." This partnership aims to "reduce preventable injuries in hospitals by 40 percent. And cut readmissions by 20 percent, targeting the return trips to the hospital that should never have occurred." Sebelius notes growing number of hospitals joining patient safety initiative. Modern Healthcare (5/5, Daly, Subscription Publication) reported, "More than 1,200 hospitals have signed up to participate in HHS's $1 billion infection prevention program in the three weeks since it was launched, HHS Secretary Kathleen Sebelius said late Wednesday." These "hospitals are among 2,500 total provider applicants for contracts to reduce preventable harm through the Partnership for Patient safety initiative, which was unveiled April 12 and funded through the Patient Protection and Affordable Care Act." Sebelius said that "what really sets this partnership apart from previous efforts is how eager they were to join."
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GOP lawmakers withdraw from plan to overhaul Medicare
May 6, 2011
A story noting that GOP lawmakers were retreating from the House plan to overhaul Medicare was widely covered by print media, while network television stations instead focused on President Obama's visit to ground zero. Most sources suggested that this shift was a plus for Democrats, while the GOP was left somewhat confused about the party leadership's plans to address Medicare's impact on the deficit. The AP (5/6, Taylor, Alonso-Zaldivar) reports, "The GOP plan to replace Medicare with vouchers will have to wait, party leaders acknowledged Thursday as lawmakers and the White House bowed to political realities in pursuing a deal to allow more government borrowing in exchange for big spending cuts. Both sides hinted at movement and Vice President Joe Biden reported progress from an initial negotiating session." The New York Times (5/6, A1, Hulse, Calmes, Subscription Publication) reports on its front page that although "top Republicans insisted that they remained committed to the Medicare initiative, which had become the target of intense attacks by Democrats and liberal groups in recent weeks, the lawmaker who would have to turn the proposal into legislation said he had no plans to do so any time soon." Dave Camp (R-MI) "said that while he still supports the party's Medicare approach, opposition from Democrats made it pointless to proceed." The Wall Street Journal (5/6, Hook, Lee, Subscription Publication) quotes Camp as saying, "Frankly, I'm not interested in talking about whether the House is going to pass a bill that the Senate shows no interest in. ... I'm not interested in laying down more markers." House Speaker John Boehner (R-OH) agreed with Camp's comments, and pointed out that they represented a "recognition of the political reality that we face." The Los Angeles Times (5/6, Mascaro, Parsons) reports, "In lieu of such an ambitious plan, Republicans are pressing for a series of steep but less dramatic spending cuts as their top deficit-reduction strategy." Democrats and Republicans "also talked of making a commitment to long-term budget cuts that would be enforced by so-called trigger mechanisms that could automatically impose deficit reductions if Congress failed to act in years to come." But, later on, Rep. Eric Cantor (R-VA), "the majority leader, who represented House Republicans at the meeting with Biden," said, "I have not taken Medicare off the table, but the president has. ... The reality is this president has excoriated our budget plan and the Medicare proposal." Politico (5/6, Rogers) reports, "The House Republican confusion over the party's Medicare stance Thursday underscores two worries for the GOP -- an often insecure, rivalrous leadership and a very bright Budget Committee chairman given to jumping ahead of his troops." Similarly, CNN (5/6, Bash, Walsh) reports, "Top House Republicans appeared divided Thursday on whether to keep pushing a controversial plan to overhaul Medicare -- creating what some GOP aides admit is a confused message on an already politically charged topic." In fact, "a senior House GOP source told CNN the story caught other House Republican leaders off guard, since it appeared Cantor was taking the GOP Medicare proposal off the table in negotiations before even stepping into the room." The GOP source stated, "It makes it look like we're not going to hold the line, and makes it look like we're going to cave."
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Databases created to track artificial hip, knee success
May 4, 2011
Bloomberg News (5/3, Farrell) reported, "Databases created by two doctors' groups are now tracking the success rates of artificial hips and knees in the US following a Johnson & Johnson (JNJ) unit's decision last year to recall a hip implant used on 93,000 patients." The American Joint Replacement Registry, "which is funded by orthopedists, prosthetic manufacturers, insurance companies and hospitals, began collecting data from 16 hospitals in December as part of a pilot program, said its chairman, David Lewallen, a professor of orthopedic surgery at the Mayo Clinic in Rochester, Minnesota." The other "registry, funded with a $12 million grant from the Agency for Health Care Research and Quality, a division of the US Department of Health Care and Human Services, is being run by the University of Massachusetts Medical School, according to the registry website."
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Robo-signing controversy delays ripple through foreclosure system
May 4, 2011
The Wall Street Journal (5/4, Timiraos, Subscription Publication) reports the controversy over law firms that acted as foreclosure mills has spread delays through the legal system. After banks dropped some law firms for "robo-signing" mortgage documents, they were left scrambling for replacement attorneys in states that process mortgages through the legal system. Consequently, the banks' foreclosure cases have faced delays, and in some cases, they have had to re-file the cases. LATimes backs California Senate bill to block foreclosure while banks offer modifications. The Los Angeles Times (5/4) says in an editorial that companies "that service most mortgages are still struggling with the volume of loans going bad, in large part because they are woefully understaffed. An extreme example of the problem is when one arm of a mortgage servicing company forecloses on a home even as another arm is offering to modify the loan in order to rescue the borrower. A state Senate committee is considering a bill to block that from happening, and lawmakers should support it." Massachusetts Supreme Court ponders ownership rights amid foreclosure muddle. Bloomberg News (5/3, Weidlich) reported, "The Massachusetts Supreme Judicial Court heard oral arguments today in the appeal of a lower-court decision that said the buyer of residential property in Haverhill, Massachusetts, never owned it because US Bancorp foreclosed before it got the mortgage." A lower court determined Francis Bevilacqua didn't have any legal standing to challenge the property's original owner "to say whether he had a claim on the property." His lawyers assert in their appeal the judge "confused requirements for the law used to prove one's title to a property with those for the law their client sued under, the so- called try-title statute, through which one party seeks to force another to assert or waive a potential claim on the property." Reuters (5/2, Kerber) reported the justices expressed caution in taking a clear side, noting that favoring banks could legitimize the sell of property with partial paperwork, but noted the "situation where thousands of people have purchased in good faith from banks who have foreclosed on properties." US sues Deutsche Bank over mortgage practices. The New York Times (5/4, Story, Subscription Publication, 950K) reports that the Justice Department "sued Deutsche Bank on Tuesday, accusing it of lying about the quality of home loans it handled under a government program and demanding that the bank repay hundreds of millions of dollars of losses on those loans." The mortgages, which are guaranteed by the Federal Housing Administration, "are expected to cost the government more than $1 billion" and originated from loans issued by MortgageIT, which Deutsche Bank acquired in 2007. The FHA "said it discovered the fraud in 2009. Officials from the Justice Department and the Department of Housing and Urban Development said the lawsuit should serve as a warning to other lenders that are issuing loans using a government guarantee."
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House passes GOP bill to cut funding for health insurance exchanges
May 4, 2011
The AP (5/4, Abrams) reports the House Republican "drive to dismantle the new health care law piece by piece advanced Tuesday with a vote to disrupt the flow of federal dollars for health insurance exchanges, an integral part of the law's goal of expanding insurance coverage." The bill, approved on mainly party lines, 238-183, "is mainly a vehicle for Republicans to restate their case against the health care law enacted last year, since the Democratic-led Senate is likely to ignore it and the White House issued a veto threat in the event it passed." The House "is also expected to vote Wednesday on another bill to block funding for a part of the law that offers grants for school-based health center construction." The Hill "Floor Action Blog" (5/4, Kasperowicz) reports, "Republicans spent much of Tuesday on the floor arguing that the bill would repeal what amounts to an unlimited 'slush fund' that the Department of Health and Human Services (HHS) can give to states. The program was established under last year's healthcare law, but does not does not limit HHS to a specific spending level." GOP lawmakers also "noted that HHS Secretary Kathleen Sebelius told members that she believes she has unlimited funds and does not have to seek additional permission to spend more, which they said means spending could exceed the $14 billion estimated by the Congressional Budget Office over the next 10 years." The National Journal (5/4, McCarthy, Subscription Publication) also reports, "The legislation from Energy and Commerce Chairman Fred Upton, R-Mich., would stop Health and Human Services Secretary Kathleen Sebelius from giving states unlimited funds until 2015 to establish insurance exchanges. The agency has already given $49 million to 48 states and the District of Columbia." The Hill (5/4, Baker) reports in its "Healthwatch" blog, "Rep. Frank Pallone (D- N.J.) said de-funding the exchange grants would reduce states' ability to create exchanges tailored to their own needs." But, "Rep. Michael Burgess (R-Texas) argued that even if states receive planning grants and authorize their own exchanges, they don't truly have flexibility over how to structure the new insurance marketplaces. The reform law sets criteria that every exchange, state-run or otherwise, must meet." CQ (5/4, Attias, Subscription Publication) also covers the story. Politico (5/4, Nather) reports the GOP bills "are getting smaller and narrower -- going after shrinking slices of President Barack Obama's health care law, rather than the whole thing." The votes "come after the House has failed in two efforts to block the entire law -- the repeal bill the House passed in January, later blocked in the Senate, and the effort to defund the whole law that met the same fate after it was stripped out of the stopgap spending bill to fund the government for the rest of the year." Still, Republican lawmakers "and GOP strategists say the House has to keep taking the votes -- even if they're narrow and temporarily overshadowed -- so Republicans can keep building the case to their base that they've tried everything to get rid of the health care law." GOP plans to continue "attacks" against healthcare law. The Hill (5/4, Kasperowicz) "Floor Action Blog" reports, "Rep. Marsha Blackburn (R-Tenn.) on Tuesday warned her Democratic colleagues that House Republicans will continue to attack last year's healthcare law until all of it is repealed." GOP lawmakers "also continued to focus on the federal funding for exchanges, which Health and Human Services Secretary Kathleen Sebelius has said is an unlimited fund she can use. Several Republicans bristled at the idea of giving HHS a blank check to fund state programs."
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Studies find guidelines on mammograms can lead to more severe breast cancer
May 3, 2011
Bloomberg News (5/3, Wechsler) reports three radiologist-led studies have found that "women under 50 who follow the advice of a US panel to forgo annual mammograms are risking more severe forms of breast cancer because of it." Failure to receive "regular breast screenings left women more likely to discover cancer at an advanced stage, retrospective research at hospitals in Ohio and Missouri found. The delay resulted in larger tumors and a worse prognosis once the cancer was uncovered, the data found." CNN (5/3, Park) reports on its website that the studies, which "do not appear in peer-reviewed journals," are to "be presented at the American Roentgen Ray Society annual meeting." They "suggest that fewer physicians are recommending annual mammograms for women in their 40s, fewer patients in that age group are getting screened and that tumors found through routine mammography are more likely to be detected in early stages of cancer. The studies examined the impact of the controversial guidelines issued by the US Preventive Services Task Force, a federal advisory board." Health Imaging (5/3, Fratt) reports, "Prior to the 2009 guidelines, for patients aged 40 to 49, 56 percent of physicians recommended screening mammography, 33 percent recommended biannual screening and 11 percent advised against screening. After the guidelines were revised, 20 percent recommended annual screening, 18 percent recommended biannual screening and 8 percent advised against screening." Health Imaging (5/3) reports separately that Paul Dale, MD, chief of surgical oncology at Ellis Fischel Cancer Center at the University of Missouri School of Medicine, said research "found that 20 percent of women diagnosed with breast cancer in our institution are under age 50, and almost half of their tumors were detected through mammography. Given recent advances in targeted treatment of early stage cancer, under these new guidelines, younger breast cancer patients not undergoing screening and early detection may miss out on important therapy that could significantly impact their survival," Dale added.
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Bristol-Myers recalling one lot of warfarin
May 3, 2011
The AP (5/3) reports, "Bristol-Myers Squibb Co. said Monday it is recalling one production lot of its blood thinner Coumadin [warfarin] after finding an oversize tablet." The AP adds, "an excessive dose of Coumadin, or warfarin, could create an increased risk of bleeding." The company "said it has notified the Food and Drug Administration about the recall." MedPage Today (5/2, Neale) reported that "the recall applies to Coumadin Crystalline 5 mg tablets -- lot number 9H49374A -- in 1,000 count bottles, which are distributed to pharmacies for dispensing to customers in prescription quantities."
Reported by the American Association for Justice
FDA to look at how pharmaceutical companies websites' influence consumers
May 2, 2011
Bloomberg News (4/28, Peterson) reports, "Consumer reactions to prescription- drug websites will be assessed by" the Food and Drug Administration "researching how to apply decades-old advertising rules to social media." The FDA "proposed three studies in which participants would answer questions after viewing various versions of a website touting a fictitious drug, according to a notice to be published" today in the Federal Register. The agency said that "the proposed web-advertising studies are 'relevant to current policy questions and debate and will complement qualitative research we plan to conduct on issues surrounding social media.'"
Reported by the American Association for Justice
Supreme Court denies request for expedited review of health law
April 26, 2011
The Supreme Court's decision not to grant fast review to a legal challenge of the healthcare reform law generated extensive print coverage but no mention on network TV, where news of the royal wedding and severe weather dominated the broadcasts. Much of the coverage cast the decision as favoring supporters of the law. Most noted that the court rarely granted fast review, and that Justice Kagan's participation in the decision probably meant a tougher battle for opponents seeking to overturn the health care law. USA Today (4/26, Biskupic), for example, reports, "The Supreme Court's rejection Monday of a request from Virginia officials to hear the constitutionality of the federal health-care law ensures that the legal battle will play out first in lower appeals courts." The Wall Street Journal (4/26, Kendall, Subscription Publication, 2.02M) reports that all nine justices participated in the decision, and the ruling came with no comment, reasoning, recorded vote, or public dissent. Some Republicans have questioned whether Justice Elena Kagan should participate, pointing to her previous post as Solicitor General. Some Democrats, meanwhile, have called for the recusal of Justice Clarence Thomas, citing the outspoken stance of his wife, Virginia Thomas, who has been an avid public opponent of the health reform law. The Huffington Post (4/26, Stein) concludes, "With Kagan apparently set to vote in the Supreme Court's ultimate decision on the Affordable Care Act (and the case is destined to eventually end there) the chances that the law, or part of it, will be ruled unconstitutional are diminished." Meanwhile, the New York Times (4/26, A18, Liptak, Subscription Publication) notes that Kagan has maintained "that she had had almost nothing to do with the administration's plans to defend the health care law against legal challenges. .. Documents released last month under the Freedom of Information Act to CNS News, a conservative Web site, appear to confirm that she took pains to avoid involvement in meetings concerning challenges to the health case law." Politico (4/26, Haberkorn) reports, "The move means the case will proceed through the 4th Circuit Court of Appeals. Oral arguments are scheduled for May 10." The AP (4/26, Sherman), meanwhile, says that "the case still could reach the high court in time for a decision by early summer 2012." The Washington Times (4/26, Cunningham) reports that Virginia Attorney General Ken Cuccinelli "asked the justices in February to redirect it out of federal appeals court and resolve questions about its constitutionality more quickly."
The Washington Post (4/26, Barnes) notes that Cuccinelli had told the court that "it should short-circuit the usual appeals process because of a 'palpable consensus in this country that the question of PPACA's constitutionality must be and will be decided in this court.'" In response to the decision, "Cuccinelli said it was 'disappointing but not surprising,' given the rarity of such expedited cases." More health law challenges pending. The Christian Science Monitor (4/26, Richey) reports, "To date, federal district judges have issued five decisions on the constitutionality of the health-care law's individual mandate -- the requirement that each citizen must purchase a government-approved level of health insurance or pay a penalty. ... In addition to the Fourth Circuit in Richmond, appeals are pending at the Eleventh Circuit in Atlanta, the Sixth Circuit in Cincinnati, and the federal appeals court in Washington, DC. ... Depending on how quickly the appeals courts announce their decisions, one or more of these cases could be appealed to the Supreme Court as early as next term."
Reported by the American Association for Justice
Award in Risperdal lawsuit against Johnson & Johnson unit could reach billions
April 26, 2011
The AP (4/26, Kinnard) reports, "It's now up to a Spartanburg County judge to decide how much a Johnson & Johnson subsidiary should pay South Carolina for deceptive marketing of" schizophrenia drug Risperdal (risperidone). A jury ruling last month determined Janssen Pharmaceutica, Inc. "violated the South Carolina Unfair Trade Practices Act by sending misleading letters to about 7,200 doctors in South Carolina downplaying the links between diabetes and" Risperdal. "In a court exhibit, attorneys for the state argued that they see the number of violations as potentially including every single prescription, sample box or 'Dear Doctor' letter written since the mid-1990s -- numbers that reach into the millions. Considering the 620,000 Risperdal prescriptions written for people on Medicaid and the state health plan alone, that could mean more than $3.1 billion."
Reported by the American Association for Justice
Medical Errors May be 10 Times More Likely Than Originally Thought
April 22, 2011
Several news sources including Bloomberg.com and Fiercehealthcare.com have reported on a new study published in Health Affairs that reveals U.S. hospitals and regulators fail to record 90% of patient injuries, infections and other safety concerns. The study, conducted by researchers at the University of Utah and the Institute for Healthcare Improvement, reviewed 795 patient records where four adverse events were voluntarily (and anonymously) reported by providers. In their review of the patient records, the researchers found 354 instances of “adverse events” had occurred. When using guidelines established by the Agency for Healthcare Research and Quality, only found 35 instances of adverse events were found in the same set of patient records. David Classen, a professor at the University of Utah School of Medicine and co-author of the study concluded that “[a]n incomplete picture of how often patients are harmed undermines public and private efforts to improve the quality of medicine in the U.S.” The researchers did not try to establish whether the adverse events themselves were preventable. In a similar study published in the New England Journal of Medicine in November, a six-year study of hospital admissions in North Carolina found that almost one in five patients were injured by their care. The most common and expensive injuries were pressure sores and post-surgical infections.
Source: Fierce Healthcare and Bloomberg News
Judge throws out New Jersey challenge to healthcare law
April 22, 2011
Bloomberg News (4/22, Voreacos) reports, "A federal judge in New Jersey dismissed a lawsuit challenging the constitutionality of the Obama administration's health- care law." US District Judge Freda Wolfson "ruled that two men who sued without a lawyer, Nicholas Purpura and Donald R. Laster Jr., lack legal standing to challenge the 2010 Patient Protection and Affordable Care Act." The plaintiffs "claimed the law's requirement that almost every American have some form of medical insurance starting in 2014 was unconstitutional." The case is "Purpura v. Sebelius, 10-cv-4814, US District Court, District of New Jersey (Trenton)." The AP (4/22) reports that the "lawsuit also claims the measure was signed into law by a person not eligible to be president of the United States, alleging that President Barack Obama was not US-born." Modern Healthcare (4/22, Daly, Subscription Publication) quotes Wolfson as stating in her decision, "It is patently clear to this court that, contrary to what is clearly required to establish standing, plaintiffs have not alleged an injury in fact sufficient to establish standing."
Reported by the American Association for Justice
Health reform initiative to reduce medical errors discussed
April 22, 2011
The Wilmington News Journal (4/22, Ratnayake) reports, "Providing better care is the intent of one initiative under the Affordable Care Act. Known as the Partnership for Patients, the initiative is designed to improve patient safety by forging a bond between hospitals, patient advocacy groups, medical societies and government agencies." Commenting on the initiative, HHS Secretary Kathleen Sebelius said, "The challenge is to figure out how to make these models spread and accelerate this improvement." She added that American physicians "and nurses are already working as hard as they can...and telling them to solve this problem on their own would be unfair and unproductive."
Reported by the American Association for Justice
Calcium supplements may increase risk for heart attacks and strokes in women
April 21, 2011
The Washington Post (4/19, Stein) "The Checkup" blog reported that "an analysis of data collected about more than 16,000 women who participated in the landmark Women's Health Initiative found that those who started taking calcium as part of the study were at increased risk for heart attacks and strokes." The research, "published in...BMJ, found that the women who were not taking calcium when the study started but began taking it when they got into the research project were at between 13 and 22 percent increased risk. The risk occurred regardless of whether the women were taking calcium alone or combined with vitamin D, the researchers found." HealthDay (4/19, Gardner) reported that "the case against calcium became stronger when researchers added in data from 13 other, unpublished trials involving almost 30,000 women. Now the increased risk for heart attack was 25 to 30 percent and, for a stroke, 15 to 20 percent." MedPage Today (4/19, Kaiser) reported that "the authors suspect that the abrupt change in blood calcium levels after taking a supplement causes the adverse effect, rather than it being related to the total amount of calcium consumed."
Reported by the American Association for Justice
ONDCP says Congress should mandate painkiller safety training
April 21, 2011
USA Today (4/20, Ledger) reports, "To halt prescription drug abuse, the nation's fast-growing drug problem, Congress must require special training for doctors and other health care workers before they are allowed to prescribe powerful drugs such as OxyContin," ONDCP Director Gil Kerlikowske said Tuesday. The Wall Street Journal (4/20, Gleason) reports the Food and Drug Administration said Tuesday that it will require pharmaceutical companies to produce new educational tools about their opioid painkillers in an effort to reduce prescription drug abuse. Department of Health and Human Services Assistant Secretary Howard Koh said at a briefing, "This growing public-health crisis is suffocating our society." USA Today (4/20, Ledger) reports, "American Medical Association President Cecil Wilson said his organization supports the intent of the drug abuse prevention plan but is concerned 'that a key element of this strategy that relies on industry to develop educational materials and initiatives to train prescribers could in the future become a mandatory part of the DEA registration process for prescribing controlled substances.'" Bloomberg News (4/19, Larkin) reported, "Pfizer Inc. (PFE), Johnson & Johnson (JNJ) and Endo Pharmaceuticals Holdings Inc. (ENDP) will have to train doctors before they can give patients extended-release painkillers under a US plan aimed at reducing prescription drug abuse." The Food and Drug Administration said on Tuesday that "sixteen companies that make 25 pain patches and pills must create a program to teach medical professionals when these drugs should be used to combat pain and how to recognize signs that the treatments are being misused." HealthDay (4/19, Gardner) reported, "The new Risk Evaluation and Mitigation Strategy (REMS) is part of a larger multi-agency initiative announced Tuesday by the White House to reduce overall prescription drug abuse in the" US. "'This new REMS will provide tools to doctors and other prescribers for appropriate pain management to reduce risks and at the same time preserve access for patients and appropriate management of pain for those suffering from moderate to severe pain,' said Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the" FDA. "For now, the initiative will be limited to extended-release and long-acting products, which, Woodcock said, 'have a much greater risk than immediate-release because they contain more medicine.'" Modern Healthcare (4/20, Daly, Subscription Publication) reports, "President Barack Obama's administration also will push for enactment of as-yet- unintroduced legislation to require physician participation in opioid prescribing training. And Gil Kerlikowske, director of National Drug Control Policy, said he is confident that Congress would enact such a measure promptly based on the previous passage of other recent measures focused in part on opioid-abuse control." But, "if Congress does not enact a law requiring mandatory physician participation in such training, the FDA could aim to tighten control on opioid prescribing through restricted formularies." The Hill (4/19, Pecquet) "Healthwatch" blog reported, "As a first step, the FDA sent letters to opioid manufacturers on Tuesday requiring that they provide a plan for training prescribers and educating patients about the safe use, storage and disposal of opioids. They have 120 days to respond, setting in place a regulatory process that officials hope to have in place within 12 months. 'We have determined that a Medication Guide and a Communication Plan are not sufficient to mitigate the serious risks,' the letters state. 'Your (strategy) must include tools to manage these risks'" On its website, CNN (4/20, Young) reports, "'Unintentional drug overdose is a growing epidemic in the US and is now the leading cause of injury death in 17 states,' said Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention. 'There are effective and emerging strategies out there to address this problem. Support for this action plan will help us implement those strategies which will go a long way to save lives and reduce the tremendous burden this problem has on our healthcare system and our society.'"
Reported by the American Association for Justice
Sebelius highlights effort to reduce medical errors
April 20, 2011
CNN Newsroom Early (4/19, Malveaux) interviewed Health and Human Services Secretary Kathleen Sebelius. Asked about the government's initiatives to limit medical errors, Sebelius said, "Just last week, we launched a partnership for patients" that is "an effort with healthcare providers, hospital administrator, but employers and union members and business owners and government officials to say we have some of the best healthcare in the world. .. We're saying in three years, we can save 60,000 lives, prevent about three million Americans from either being injured or returning unnecessarily to the hospital, and really improve care for everyone. And we've got the tools now in the Affordable Care Act to do that."
Reported by the American Association for Justice
FDA adds website feature to give consumers better way to track recalled foods
April 19, 2011
The "Healthwatch" blog at The Hill (4/18, Pecquet) reported that the FDA changed its website so consumers can keep track of recalled foods, a measure required by the Food Safety Modernization Act, which said the FDA should create "a consumer-friendly recall search engine." The act also "gives the FDA power to recall tainted food, quarantine geographical areas and access food producers' records." The website change went live Monday.
Reported by the American Association for Justice
House votes to cut funding for health reform prevention fund
April 18, 2011
CQ (4/18, Symes, Subscription Publication) reports, "With some calling the mandate a 'slush fund,' House Republicans voted last week to strip funding for a health care overhaul provision that provides support for programs aimed at preventing tobacco use, obesity, heart disease, strokes and cancer." The measure would "repeal the section that establishes and allocates funding to the Prevention and Public Health Fund." Yet, it is "unlikely to become law. President Obama has vowed to veto it, and the Senate has rejected several attempts to roll back the overhaul." Healthcare law suffered several setbacks last week. Modern Healthcare (4/15, Zigmond, Daly, Subscription Publication) reported, "It was a tough week in Washington for the Affordable Care Act. First, House members voted April 13 to repeal the law's prevention and public health fund, which would grant authority to the HHS secretary to administer $17.75 billion in funding from 2012 to 2021." Then, President Obama "signed into law legislation that repeals the Affordable Care Act's 1099 reporting provision, which would have required businesses -- starting in 2012 -- to report all transactions worth $600 or more to the Internal Revenue Service."
Reported by the American Association for Justice
CPSC issues required safety guidelines for toddler beds
April 18, 2011
The AP (4/15) reported the Consumer Product Safety Commission issued "mandatory standards for various infant and toddler products" under Congressional instruction. The "new standard requires that the upper edge of the guardrail be at least 5 inches above the toddler bed's mattress, that testing of the bed's slats be consistent with testing for slats in cribs and that separate warning labels to address entrapment and strangulation hazards appear on the toddler beds." Convertible crib-to-toddler beds must also meet the regulations.
Reported by the American Association for Justice
Bill to protect Americans from adulterated imports garners bipartisan support
April 14, 2011
CQ HealthBeat (4/14, Adams, Subscription Publication) reports, "House Democrats and Republicans, in a rare glimpse of bipartisan interest, signaled in a hearing" of the House Energy and Commerce Subcommittee on Oversight and Investigations expressed "a willingness to give the Food and Drug Administration the authority to destroy imported pharmaceuticals that the agency believes to be fake or contaminated." Democrats on the committed "on Tuesday introduced import safety legislation (HR 1483) that, among other things, would beef up laws aimed at protecting Americans from adulterated or contaminated prescription drugs from" abroad. It would "make much more sense," FDA Commissioner Margaret A. Hamburg said, if the agency "simply had full authority to destroy questionable drugs instead of returning them to the sender, who may try again to send harmful products into the US."
Reported by the American Association for Justice
FDA website provides information on food recalls
April 14, 2011
The Louisville Courier-Journal (4/12, Carter) "Health Bytes" blog reported, "The US Food and Drug Administration is now providing search results about food recalls in a more consumer-friendly format thanks to the Food Safety Modernization Act that President Obama signed in January." Search results "appear in a table format. To conduct a search or view a table of recent recalls of food and some other types of products, such as drugs and dietary supplements, go here."
Reported by the American Association for Justice
GAO: FDA device approval process endangers patients
April 14, 2011
The AP (4/14, Perrone) reports, "Government investigators say the Food and Drug Administration is putting patients at risk by approving sensitive medical devices such as hip joints and heart defibrillators under the same streamlined system intended for power wheelchairs, stitches and catheters." Notably, the "Government Accountability Office told Congress Wednesday that the approvals remain a serious issue for the government -- more than two years after the watchdog agency first cited the problem to the FDA." In response, Dr. William Maisel, deputy director for science in FDA's device center, said that the agency "will reclassify the 26 types of high-risk devices cited by GAO before the end of 2012." The Minneapolis Star Tribune (4/14, Spencer, Moore) reports that Marcia Crosse, the GAO's director of health care, "testified at a Senate hearing that explored the need for legal or regulatory changes to the ways medical devices come to market. Many devices avoid clinical trials and win approval on the basis that they are 'substantially similar' to devices already on the market." In addition, the "Senate Special Committee on Aging...heard from a Colorado woman whose artificial hip was recalled and had to be removed from her body four years after its implantation because it was shedding toxins into her bloodstream." The FDA did not require any "human testing of the all- metal joint before it went on the market." CQ (4/14, Adams, Subscription Publication) says that the GAO findings were based on an "analysis of 3,510 voluntary recalls from 2005 through 2009." The results were "discussed as part of a debate over whether the agency should update the so-called 510(k) process, which is the main procedure for approving medical devices. The process was intended to be an approval route for products similar to those already on the market; unlike another rarely -used and more stringent review for new products, known as the premarket approval (PMA) process, the 510(k) procedure does not require manufacturers to test devices in people before selling them in the United States."
Reported by the American Association for Justice
HHS initiative aims to reduce medical errors, costs
April 13, 2011
Print media sources widely covered an announcement Tuesday that the Obama Administration was partnering with hospitals, insurers and other groups in order to reduce medical errors. Most sources considered the move a positive for the Administration. The Los Angeles Times (4/13, Levey) reports, "The Obama administration announced a broad new initiative Tuesday to reduce medical errors, partnering with private insurers, business leaders, hospitals and patient advocates to tackle a problem that kills thousands of Americans every year." This "campaign, funded by the healthcare overhaul the president signed last year, aims to cut by 40% over the next three years the number of harmful preventable conditions such as infections that patients acquire in the hospital." HHS Secretary Kathleen Sebelius made the announcement about the Partnership for Patients initiative, and CMS Administrator Donald Berwick noted that the initiative has "big goals." The AP (4/13) reports, "Sebelius said the new national Partnership for Patients will help other hospitals adopt those proven safety strategies." The program "is funded by $1 billion from the new healthcare law, but has the potential to save Medicare up to $10 billion in that same time." The New York Times (4/13, Abelson, Subscription Publication) "Prescriptions" blog quotes Sebelius as saying, "Americans go the hospital to get well, but millions of patients are injured because of preventable complications and accidents. ... Working closely with hospitals, doctors, nurses, patients, families and employers, we will support efforts to help keep patients safe, improve care, and reduce costs. Working together, we can help eliminate preventable harm to patients." According to the CNN (4/13) "The Chart" blog, the initiative "will save 60,000 lives over the next three years by reducing millions of preventable hospital-related complications and injuries. Sebelius says the new partnership will also save about $35 billion in healthcare costs including $10 billion in Medicare savings." Meanwhile, American Medical Association president Cecil Wilson, MD, said that the group's "physicians will be encouraged to do everything they can to reduce adverse events and hospital readmissions." Wilson added, "We know that if we ensure that a patient's primary care physician receives their discharge papers within 24 hours of their release from the hospital, the likelihood of hospital readmission will be reduced." The Hill (4/13, Pecquet) reports in its "Healthwatch" blog that HHS aims to accomplish the initiative's goals "by disseminating best practices that have already allowed the nation's best hospital systems to cut preventable errors significantly." Berwick noted, "Blame and accusation are not the answers; teamwork, improvement are the answers." The AMA's Wilson is also quoted as saying, "We all need to do everything we can to avoid preventable patient illness and injuries while also working to ensure that patients are able to heal without complications." Reuters (4/13, Smith) reports that another goal of the initiative is to cut hospital readmissions by at least 20 percent. Sebelius noted that 500 hospitals are already part of the effort. CQ (4/13, Reichard, Subscription Publication) reports, "Because the program is voluntary, making good on the projections is initially going to require a disciplined effort by hospital and other healthcare CEOs to devote time and resources to the project -- in addition to their efforts to comply with the many requirements of the healthcare law." Berwick explained that "the changes needed in healthcare delivery to meet the goals of the project will help hospitals qualify in a few years for incentive payments under the health law to improve patient safety." The PBS NewsHour (4/13, Bowser) "The Rundown" blog reports, "The partnership will begin by asking hospitals to focus on nine types of medical mistakes where there is potential for dramatic reductions in harm. These include pressure ulcers, drug reactions, childbirth complications and surgical site infections." Notably, Berwick will "oversee the new partnership." He stated, "Through strong partnerships at national, regional, state and local levels ... we are supporting the hospital community to significantly reduce harm to patients." But, FOX News (4/13, Barrett) "America's Election HQ" blog says that "the plan's parameters could be in jeopardy going forward. House Republicans have introduced a 2012 budget that would, in essence, end Medicare, and earlier this year, voted to repeal the Affordable Care Act." In addition, "some critics say the partnership initiative further proves the Affordable Care Act was bad medicine."
Reported by the American Association for Justice
Concern growing over synthetic drugs' accessibility
April 12, 2011
On its website, CBS News (4/8, Koeppen) reported that there is "growing concern over the use of synthetic substances because they're easy to find and, in some cases, perfectly legal to buy." In fact, "an 'Early Show' staffer...had no problem scoring fake pot and bath salts," and "they're having powerful effects on users." To date, "nine deaths have reportedly been linked to the use of synthetic drugs."
Reported by the American Assocaition for Justice
Patients taking high daily prescription painkiller doses may be at increased risk of death
April 7, 2011
HealthDay (4/5, Preidt) reported, "Patients who are prescribed higher doses of opioid painkiller drugs (such as Oxycontin or Vicodin) are at increased risk of death from overdose than those given lower doses," according to a study in the April 6 issue of the Journal of the American Medical Association. The researchers examined Veterans Affairs data on "750 accidental opioid overdose deaths that occurred from 2004 to 2008 and a random sample of almost 155,000 patients who received opioids to treat pain in 2004 or 2005." According to MedPage Today (4/5, Fiore), the risk of overdose death "significantly increased with doses of 100 mg/d or more of morphine (or its equivalent in other opioids), compared with doses below 20 mg/day, for all patient subgroups," including those with: "substance abuse disorders (HR 4.54, 95% CI 1.46 to 8.37); chronic pain (HR 7.18, 95% CI 4.85 to 10.65); acute pain (HR 6.64, 95% CI 3.31 to 13.31); [and] cancer pain (HR 11.99, 95% CI 4.42 to 32.56)."
Reported by the American Association for Justice
CMS unveils data on hospital-acquired conditions
April 7, 2011
CQ HealthBeat (4/7, Reichard, Subscription Publication) reports, "Federal officials announced Wednesday the release of data allowing consumers to learn how often patients in local hospitals acquire infections, develop bed sores or are harmed by gas or air bubbles entering blood vessels." Notably, information "on these and other 'hospital-acquired conditions' will guide consumers in picking hospitals and prod facilities themselves to make improvements, officials said." CMS Administrator Donald M. Berwick stated, "Any potentially preventable complication of care is unacceptable." He added that the agency is "working together with the hospital and consumer community to bring hospital acquired conditions into the forefront," and prevent patients from being harmed. The Hill (4/7, Millman) reports in its "Healthwatch" blog, "Medicare beneficiaries for the first time will have access to data about hospital-acquired condition (HAC) rates." For more than two years, CMS has "banned reimbursements for care resulting from HACs, and the healthcare reform law enacted a year ago requires the same policy to be extended to state Medicaid programs." Study: Hospitals, regulators may record just 10 percent of errors. Bloomberg News (4/7, Young) reports, "Hospitals and US regulators fail to record at least 90 percent of patient injuries, infections and other safety issues," according to a new review, which "uncovered 354 so-called adverse events, such as pressure sores, bloodstream infections and medication errors, at three US teaching hospitals." In fact, "a system designed by the federal Agency for Healthcare Research and Quality identified 35 cases at the same facilities while the hospitals' voluntary reporting programs found four, according to the study," which utilized the Institute for Healthcare Improvement's (IHI) Global Trigger Tool to arrive at these conclusions. Modern Healthcare (4/7, McKinney, Subscription Publication) reports, "The study's authors warned that hospitals using voluntary reporting systems alone to assess patient safety 'may be seriously misjudging actual performance.'" In addition, they "cautioned against reliance on AHRQ's Patient Safety Indicators, which missed most of the events identified by the IHI's tool, they said." Reuters (4/7, Steenhuysen) reports that the research appeared in the journal Health Affairs and were supported by a grant from the Robert Wood Johnson Foundation. Falls, burns, trauma most common patient injuries in Utah hospitals. The Salt Lake Tribune (4/7, May, McCann) reports, "Falls, burns or other types of trauma are the most common injuries that patients experience while staying in Utah hospitals, a problem they appear to experience more often than patients nationally," according to data disclosed by Medicare which report "how often hospitals report serious conditions and complications that developed during a patient's stay." The Tribune points out, "Of the 31 Utah hospitals analyzed, 17 reported a total of 56 falls or injuries caused by trauma."
Reported by the American Association for Justice
Antidepressants associated with accelerated atherosclerosis in middle-aged men
April 5, 2011
Bloomberg News (4/3, Cortez) reported, "Antidepressants may narrow the arteries of middle-aged men, potentially putting them at risk for heart attacks and stroke," according to a study presented at the American College of Cardiology meeting in New Orleans. In "a study involving 513 male twins, with an average age of 55, found those who took medications like Forest Laboratories Inc.'s Lexapro [escitalopram], Eli Lilly & Co.'s....Cymbalta [duloxetine], or Pfizer Inc.'s Zoloft (sertraline) had thicker blood vessel walls." What's more, "the increase, a measure of fatty-plaque buildup linked to atherosclerosis, was seen regardless of what type of antidepressant the men were taking." The Los Angeles Times (4/2, Maugh) reported, "Overall, when the researchers adjusted for age, diabetes, blood pressure and other factors, they found that the intima-media thickness of men taking antidepressants was 37 microns (about 5%) thicker than that of men not taking the" medications. "When the team looked at 59 twin pairs in which one twin was taking the drugs and the second was not, the artery was 41 microns thicker in the twin taking" antidepressants. HealthDay (4/2, Reinberg) reported, "Since each additional year of life is associated with a small increase in intima-media thickness, a brother taking antidepressants is physically four years older than the brother not taking antidepressants," the researchers "contended. They also said that even a small increase in intima-media thickness can increase the risk of a heart attack or stroke by 1.8 percent." In a conversation with HeartWire (4/2, O'Riordan), the study's lead author, Amit Shah, MD, PhD, of the Emery University School of Medicine, "said that increased atherosclerotic burden of the carotid artery is not on the radar of practicing clinicians, including psychiatrists, and that most are instead concerned with sleep, appetite, and sexual side effects as well as weight gain." Therefore, "while these data should not be used to take patients off medications, the clinician needs to assess the benefits and risks on a patient-by-patient basis."
Reported by the American Association for Justice
FDA launches new website on recalled foods
April 5, 2011
The Los Angeles Times (4/5, Zajac) reports the Food and Drug Administration has launched a website that compiles food "recall notices in a searchable table." The FDA "webpage displays information on recalls since 2009 by date, product brand name, product description, the reason for the recall and the firm doing the recalling. It also includes an image of the product label and links to the press release on each recall -- which generally contain additional information." The Portland (ME) Press Herald (4/5) reports, Mike Taylor, FDA deputy commissioner for foods, said in a statement, that recalls "mandatory or otherwise, are serious and we must do everything possible to make it easier for people to know about these recalls so they can take all appropriate steps to protect themselves and their families."
Reported by the American Association for Justice
FDA proposes rules requiring chain restaurants to post calorie counts
April 4, 2011
The AP (4/2, Jalonick) said the Food and Drug Administration on Friday proposed new rules that require chain restaurants "with 20 or more locations, along with bakeries, grocery stores, convenience stores and coffee chains, to clearly post the amount of calories in each item on menus, both in restaurants and drive-through lanes. The new rules will also apply to vending machines where calorie information isn't already visible on the package." But, movie theaters and any businesses who do not primarily sell food would be exempt. FDA deputy commissioner for foods Mike Taylor said, "'We've got a huge obesity problem in this country and its due in part to excess calorie consumption outside the home. Consumers generally when you ask them say they would prefer to have that information." The Los Angeles Times (4/2, Zajac) said the rules represent "the latest attempt to gain ground against the nation's epidemic of obesity." In this connection, FDA deputy commissioner Taylor said: "Nobody thinks that calorie information by itself solves the problem, but it's part of the tool kit. We see this as part of the overall effort to fight obesity." The new rules "would generally apply to businesses that either define themselves as restaurants or devote more than 50% of their floor area to the sale of food." Although the National Restaurant Association endorsed the publication of the proposed rules, it "anticipates many questions." The trade group promised "detailed comments to the FDA to ensure that restaurants are provided adequate time and are able to comply with the regulations effectively, as well as provide information to consumers in the most usable way." The New York Times (4/2, Neuman) explained that a preliminary FDA document on the rules released last summer "would have included movie theaters. But, Mr. Taylor said officials decided to write the rules so that they would apply only to establishments whose primary purpose was to sell food or where at least half the floor space was dedicated to food sales. 'The thinking has absolutely evolved based on comments we've gotten from a number of quarters,' Mr. Taylor said. 'This is a different drawing of the circle of what is covered by this law.'"
Lawmaker targets exemption for movie theaters. The Washington Post (4/2, Layton) noted that the rules would cover a chain kiosk housed inside another business. The Center for Science in the Public Interest "hailed the proposed rules but said that theaters and alcoholic beverages should have been included. 'If a movie theater is going to serve up thousand-calorie tubs of popcorn, 400-calorie drinks and 400- calorie boxes of candy, the least they could do is tell you about it,' said Margo Wootan, nutrition policy director for the group. Rep. DeLauro (D-CT), who authored a separate bill requiring menu labeling, said Friday that she would 'work to ensure that the final rule is strengthened' to include movie theaters and alcoholic beverages." Under the headline, "Calorie Rules Make Diets A Federal Affair," the Wall Street Journal (4/2, Adamy) said exemptions may lead to an uneven application of the rules, since customers will learn the calorie information of a Starbucks Frappuccino but not a beer at the bar.
Reported by the American Association for Justice
More than 50 percent of cardiology guideline-writing physicians report conflicts of interest
March 29, 2011
The Wall Street Journal (3/29, Burton) reports that, according to a newly published paper in the Archives of Internal Medicine, more than 50 percent of physicians with financial ties to drug and device makers who pen cardiology practice guidelines experience conflicts of interest. And, even though such incidents are often reported, researchers at the University of Pennsylvania say the risk of bias is increased, which could adversely affect patient care. Before reaching those conclusions, investigators looked at "the 17 most recent American College of Cardiology/American Heart Association clinical practice guidelines issued through 2008," HealthDay (3/28, Preidt) reported. "Of the 498 people involved in creating those guidelines, 277 (56 percent) reported a conflict of interest (COI)," and the "most common types of conflict of interest were: being a consultant or member of an advisory board, receiving a research grant, being on a speaker's bureau and/or receiving honoraria, and owning stock. Through these types of links, there were 510 commercial companies involved in the 17 guidelines, compared with only 18 non-commercial organizations." In "a joint statement on Monday, the cardiology and heart associations said that they had tightened their conflict-of- interest controls in 2010 to align with recommendations from the Council of Medical Specialty Societies," the New York Times (3/29, B3, Wilson) reports. They "now require that the people leading the group and a majority of members of any guideline-writing group be free of conflicts of interest." Still, "in a related commentary in the journal, Dr. Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic and a former president of the American College of Cardiology, called for banning most of those conflicts rather than just disclosing them." Among "other things, he noted, it 'defies logic' that experts who have acted as speakers for industry or hold stock in a company should be allowed to write guidelines that affect that company," MedPage Today (3/28, Smith) reported. He also pointed out that "such relationships 'have created a dependency that is difficult to terminate, because the leadership of professional societies is reluctant to antagonize their financial benefactors.' How much those financial ties influence the selection of guidelines committee members isn't clear, he added, but the possibility 'certainly raises appropriate concerns."
Reported by the American Association for Justice
FDA asks Triad Group to halt drug making and distribution
March 29, 2011
MSNBC (3/28, Arnold) reported that the Food and Drug Administration has asked Triad Group to voluntarily "stop making and distributing all of its drug products." Shelly Burgess, an FDA official, explained that the request was made after an inspection on Monday. According to MSNBC, the FDA "pointed out contamination concerns at the plant as far back as 2009." Triad "voluntarily recalled its sterile lubricating jelly in December, citing possible contamination" and "recalled all of its alcohol prep pads and swab sticks days before the end of another FDA inspection" and "this month Triad issued a voluntary recall of its iodine prep pads, citing possible contamination from a different organism."
Reported by the American Association for Justice
FDA urges consumers to stop using Soladek vitamin solution
March 29, 2011
The AP (3/29) reports that the Food and Drug Administration "warned consumers Monday to avoid Soladek vitamin solution because it may contain dangerously high levels of vitamins." The FDA "said it has received seven reports of serious health problems among people who used the product, including vomiting, diarrhea, and kidney malfunction." The agency "urged consumers who have Soladek to stop using it immediately and contact their doctor if they are experiencing symptoms."
Reported by the American Association for Justice
Advocacy group finds 55% of physicians with restricted privileges are not disciplined
March 16, 2011
The Orlando Sentinel (3/16, Shrieves) reports that for about the past 20 years, "state medical boards responsible for disciplining doctors have failed to punish more than half of those whose hospitals revoked or restricted their privileges, according to a new report released Tuesday" by the group Public Citizen, a nonprofit consumer advocacy group. "Altogether, the report says, 32 states let more than half of the offending doctors go without any reprimand." In Florida alone, the report "found that 63 percent of the doctors whose hospital privileges were restricted or revoked were not disciplined by the state's Board of Medicine." The Washington Post (3/16, Sun) reports, "Among the most serious violations, which involved 2,071 of the 5,887 physicians who were not disciplined, were doctors who posed an immediate threat to health or safety, were incompetent or negligent, or provided substandard care, the study found." Sidney Wolfe, director of Public Citizen's Health Research Group and overseer of the study, "said he is urging US Health and Human Services Secretary Kathleen Sebelius to have the agency inspector general's office reinstitute investigations of state medical boards." CQ HealthBeat (3/16) reports that the consumer advocacy group is also "notifying the 33 medical boards that have the worst records in disciplining these doctors."
Reported by the American Association for Justice
Justice Department seeks expedited appeal of healthcare law ruling
March 10, 2011
Bloomberg (3/10, Harris) reports that the "US Justice Department is seeking an expedited appeal of a federal judge's ruling striking down President Barack Obama's health-care reform legislation." The federal government is "asking the US Court of Appeals in Atlanta to speed its review of the Jan. 31 decision by US District Judge C. Roger Vinson in Pensacola, Florida." Bloomberg adds that "Vinson found unconstitutional the Patient Protection and Affordable Care Act provision requiring individuals to procure insurance coverage starting in 2014."
The AP (3/10) reports the "Obama administration is asking a federal appeals court in Atlanta to act swiftly on a lawsuit challenging the constitutionality of the government's healthcare overhaul." According to "a seven-page filing, the Justice Department says expedited treatment of the case is warranted because of the far-reaching nature of the decision by a federal judge who declared the entire law unconstitutional." The AP adds that the "government is proposing that it file its first set of court papers on the issues in the case by April 18 and that those challenging the law file theirs by May 18."
Politico (3/10, Haberkorn) reports that the Administration's lawyers said, "Expedition in this case is particularly warranted because of the district court's unprecedented severability ruling, which presents issues that the federal government has not previously addressed in appellate briefs and covers numerous provisions of the Act already in effect."
CNN International (3/10, Mears, Cratty) reports on its website that the "11th Circuit has not indicated whether it would agree to the expedited schedule, and there was no immediate response from lawyers representing Florida and 25 other states that had filed the original lawsuit opposing the law." Notably, the "federal government wants to know whether these provisions can continue while the issue is under appeal, particularly in the 26 states that filed this lawsuit." CNN adds that "Oklahoma and Virginia have filed separate legal challenges that are concurrently working their way through appeals courts in Cincinnati and Richmond."
The Palm Beach (FL) Post (3/10, Singer, Kam) reports that the "Justice Department ignored pleas that it fast-track its appeal directly to the US Supreme Court, instead filing an appeal and request for speedy hearing with the 11th US Circuit Court of Appeals in Atlanta." The Post adds that a "hearing could come as early as midsummer, soon after two other federal appeals are scheduled." Separately, this week the Florida "Senate approved [SJR 2] a proposed constitutional amendment [by a 29-10 vote] allowing Florida to opt out of the federal healthcare law."
The Dayton (OH) Business Journal (3/10) reports that the "suit had the support of 26 states -- including Ohio -- as well as two private citizens and the National Federation of Independent Businesses." The Journal adds, according to a research group, consumers "and small businesses in Ohio will face significantly higher insurance premiums and could see coverage denials and price discrimination if the federal healthcare law is repealed." NYTimes: Vinson correct in allowing health reform implementation to proceed.
The New York Times (3/10) editorializes that a "federal district judge in Florida backed down, as he should have, from his effort to bully the Obama administration into halting implementation of the new healthcare reforms even before the issue of the law's constitutionality is resolved by higher courts." Federal Judge Vinson, "who is handling a lawsuit brought by 26 states, two private citizens and a federation of small businesses, was the only judge to rule that the entire reform law was void and then strongly implied that the administration should immediately stop implementing it." The Times says that Vinson correctly "stayed his own ruling on condition that the administration seek an expedited appellate review of his decision, a step the Justice Department began with court filings on Tuesday." Justice Department infuriates Judge Vinson.
Heartland Institute fellow Maureen Martin writes in the Washington Times (3/10) op-ed section that in "the proceedings prior to January, the Justice Department had acknowledged to Judge Vinson in writing the equivalence of these two remedies and had 'specifically insisted that they would honor' (in Judge Vinson's words) the declaratory judgment as an injunction -- meaning they promised the court they wouldn't enforce the healthcare law." Yet, "mere hours after Judge Vinson's opinion was issued, the Justice Department broke its word and announced that it would ignore the court order and continue to enforce Obamacare." Martin says that these types of actions by the Justice Department has made Judge Vinson and other judges, such as Judge Feldman who is involved with the oil spill moratorium case, "furious."
Reported by the American Association for Justice
Study finds poor communication between EDs, primary-care physicians
March 10, 2011
Scripps (3/10, Bowman) reports that a new study "underscores how haphazard communication between" emergency department (ED) doctors and primary-care physicians "can undermine effective care." The Center for Studying Health System Change "matched 21 pairs" of ED and primary-care physicians "working out of the same hospital." The researchers found patients' regular physicians "seldom contact" the ED, even if "they send a patient to the hospital," and ED physicians "rarely contact the primary-care docs either to clarify information or discuss treatment plans for a patient." However, when the two physicians "were able to connect on the phone, the result was often much more positive." Notably, physicians in the study "said sharing medical records is cumbersome no matter what the mode."
Reported by the American Association for Justice
Certain types of medical errors much less likely to occur at top-rated US hospital
March 10, 2011
HealthDay (3/9, Preidt) reported, "Certain types of medical errors are 46 percent less likely to occur at top-rated US hospitals than bottom- ranked hospitals," according to the annual HealthGrades Patient Safety in American Hospitals report. To reach that conclusion, "HealthGrades researchers analyzed 40 million Medicare patient records from 2007 to 2009 and focused on 13 patient safety indicators, such as bed sores, bloodstream infections from catheters, foreign objects left in the body after procedures, and excessive bleeding or bruising after surgery," then used "patient safety indicators published by the US Agency for Healthcare Research and Quality...to identify preventable medical errors and which hospitals were in the top five percent for avoiding those errors."
Reported by the American Association for Justice
Study suggests patients taking opioid painkillers not being monitored adequately
March 10, 2011
HealthDay (3/9, Dotinga) reported that although "opioid painkillers, such as oxycodone, can lead to addiction and overdose, people who take them are frequently not tracked by the primary care doctors who prescribed the drugs," according a study published in the Journal of General Internal Medicine. The researchers studied medical records of "more than 1,600 people who took prescription opioids for chronic pain for an average of two years." They found that "only 8 percent of patients overall, and 24 percent of those considered high-risk for abuse, underwent drug testing, and only half made regular visits to their doctors."
Reported by the American Association for Justice
Study finds screening mammography less accurate in breast cancer survivors
February 23, 2011
Bloomberg News (2/23, Wechsler) reports, "Mammograms are more likely to miss new tumors in women who have had breast cancer before than in those without a history," according to a study in the Journal of the American Medical Association. The study reviewed "58,870 mammograms for 19,078 women with a history of the disease and the same number of screenings for 55,315 women with no history." According to HealthDay (2/22, Doheny), the study was based on 12 years of data, in which mammograms "detected 76.5 percent of the cancers in women who had never had breast cancer and 65.4 percent in those who had previously had the disease." As for false positives, "1 percent of the women without a history of breast cancer were referred for biopsy but ended up being cancer-free, compared with 1.7 percent of those with a breast cancer history." MedPage Today (2/22, Neale) reported that the researchers said the difference was "driven largely by a lower sensitivity for the detection of invasive carcinomas." Meanwhile physicians "contacted by ABC News and MedPage Today agreed that the findings do not imply" that the yearly screening recommendation for breast cancer survivors "should be changed. The study 'does raise the question, however, as to whether supplemental screening with other modalities, notably ultrasound or MRI, is appropriate in a certain subset of these women,'" according to Carol Lee, MD, chair of the American College of Radiology's commission on breast imaging.
Reported by the American Association for Justice
FDA: More than 20 antipsychotics may pose risk to newborns when taken by pregnant mothers
February 23, 2011
Bloomberg News (2/23, Peterson) reports, "Johnson & Johnson's Risperdal (risperidone) and Eli Lilly & Co.'s Zyprexa (olanzapine) are among more than 20 antipsychotic drugs that US regulators said may pose risks to newborns when taken by mothers during pregnancy." The Food and Drug Administration has "updated labeling for antipsychotic drugs to show potential side effects to children born to mothers on the medicines in the third trimester." The agency said that the listed medications may "cause abnormal muscle movements and withdrawal symptoms in newborns." According to MedPage Today (2/22, Gever), the FDA is "requiring the standardized cautions be carried on all antipsychotic drugs -- 20 different types sold under 23 brand names." All the products are "approved to treat schizophrenia; some also have been cleared for bipolar disorder." They range from the first antipsychotic "used in modern practice, chlorpromazine (Thorazine), to such newer agents as aripiprazole (Abilify) and quetiapine (Seroquel)." Medscape (2/22, Lowes) provides a complete list of the drugs that will required warnings about the risk of extrapyramidal symptoms (EPS) and withdrawal syndromes in newborns; and the FDA, in a Safety Announcement, provides more details.
Reported by the American Association for Justice
Florida ruling tossing out tobacco class-action opened industry to litigation flurry
February 22, 2011
The AP (2/18, Anderson) reported Florida Supreme Court justices' 2006 ruling tossing out a $145 billion class-action damage award against tobacco companies "has helped generate more than $360 million in damage awards in only about two dozen cases." The ruling allowed approximately 8,000 individual members of the class to pursue separate lawsuits and use the findings from the class-action. As a result, plaintiffs "must mainly show they were addicted to smoking and could not quit, and that their illness - or a smoker's death - was caused by cigarettes." Edward Sweda of the Tobacco Products Liability Project suspected "if the losing trend and multimillion-dollar verdicts continue," tobacco companies would reconsider "their long-standing policy against settling the smoker lawsuits."
Reported by the Association for American Justice
FDA warns against using terbutaline for preterm labor
February 18, 2011
USA Today (2/18, Young) reports that the Food and Drug Administration is now "requiring stronger safety warnings for a popular treatment to prevent pregnant women from prematurely giving birth. Women should not be given injections of the drug terbutaline for more than three days 'because of the potential for serious maternal heart problems and death,'" the FDA said Thursday. The agency has approved terbutaline only to treat "specific respiratory conditions," such as asthma. Los Angeles Times (2/17, Healy) "Booster Shots" blog noted that terbutaline may "relax smooth muscles, including the uterus, thereby disrupting contractions in women who have gone into labor too soon." Although widely administered in hospitals as to forestall labor, physicians also "prescribe it in pill form to prevent premature labor in women who are carrying multiple fetuses or have a history of preterm labor." According to the MedPage Today (2/17, Frieden), the FDA said the label change was based on its review of post-marketing reports of "maternal death and serious cardiovascular adverse events" submitted to the Adverse Event Reporting System (AERS). An AERS search identified "16 maternal deaths" from the initial marketing of the drug in 1976 until 2009. In addition, the agency said it has identified "12 maternal cases of serious cardiovascular events associated with use of terbutaline that were reported between Jan. 1, 1998 and July 2009."
Reported by the American Association for Justice
Pfizer to pay $10 million compensatory damages in menopause treatment case
February 9, 2011
Bloomberg (2/9, Feeley, Milford) reports, "Pfizer Inc. must pay more than $10 million in damages to an Arkansas woman who blamed her cancer on the company's Prempro (conjugated estrogens and medroxyprogesterone) menopause drug, after an appeals court reinstated a jury verdict." A Pennsylvania appeals court "yesterday overturned a judge's ruling that Pfizer's Wyeth unit deserved a new trial in connection with Mary Daniel's claim that Prempro caused her breast cancer." Evidence in Daniel's case "showed that she took Prempro for about 16 months starting in December 1999 and was diagnosed with breast cancer in July 2001."
Reported by the American Association for Justice
VA finds more notification failures involving equipment concerns at Miami hospital
February 9, 2011
The Miami Herald (2/9, Tasker) reports, "The Veterans Administration said Tuesday it has found another 12 South Florida veterans who never were notified they might have received colonoscopies with improperly cleaned equipment at the Miami VA hospital as far back as 2004." The department, "which last year said it had taken extensive steps to prevent another such notification error, again blamed the way in which the hospital keeps medical records" both electronically and in supplemental paper log books. VA officials "said this error was discovered when the Miami US Attorney's Office, gathering information related to veterans who have filed lawsuits in the matter, asked the Miami VA hospital to recheck its records."
Reported by the American Association for Justice
GSK to settle rosiglitazone maleate death lawsuits
February 8, 2011
Bloomberg (2/9, Feeley, Milford) reports, "Pfizer Inc. must pay more than $10 million in damages to an Arkansas woman who blamed her cancer on the company's Prempro (conjugated estrogens and medroxyprogesterone) menopause drug, after an appeals court reinstated a jury verdict." A Pennsylvania appeals court "yesterday overturned a judge's ruling that Pfizer's Wyeth unit deserved a new trial in connection with Mary Daniel's claim that Prempro caused her breast cancer." Evidence in Daniel's case "showed that she took Prempro for about 16 months starting in December 1999 and was diagnosed with breast cancer in July 2001." Bloomberg (2/8, Feeley) reports, GlaxoSmithKline Plc "agreed to pay more than $250 million to resolve about 5,500 claims related to its Avandia (rosiglitazone maleate) diabetes drug and avoid the first trial over claims it can kill users, two people familiar with the accords said." GSK agreed to settle the lawsuits "claiming the drug causes heart attacks and strokes for an average of at least $46,000 each, said the people, who declined to be identified because they weren't authorized to speak publicly." On Sept. 23, GSK said it would "stop promoting Avandia worldwide after regulators said the treatment would be withdrawn from the market in Europe and sales would be limited in the US because of studies linking the drug to increased risks of heart attacks."
Reported by the American Association for Justice
GSK tightens restrictions on rosiglitazone label
February 8, 2011
MedPage Today (2/7, Gever) reported, "Obeying a 2010" Food and Drug Administration directive, GlaxoSmithKline, "the manufacturer of the star-crossed diabetes drug rosiglitazone (Avandia) has now finalized new label language -- restricting the drug's use to patients already taking it or to those who have failed other antiglycemic drugs." According to the new label, rosiglitazone "may be started only in patients who 'are unable to achieve adequate glycemic control on other diabetes medications, and, in consultation with their healthcare provider, have decided not to take pioglitazone (Actos) for medical reasons.'" HeartWire (2/7, O'Riordan) reported, "The new label has been changed to highlight the increased cardiovascular risks with the drug, noting in a boxed warning that in a meta-analysis of 52 studies, most of which compared rosiglitazone with placebo, the drug was associated with a significantly increased risk of MI." The new label highlights the "lack of comparative clinical trials between rosiglitazone and pioglitazone but notes that pioglitazone, in a study compared with placebo, was not associated with an increased risk of death or MI." In addition, the boxed warning "includes previous caveats that rosiglitazone is not recommended in patients with symptomatic heart failure and that it can exacerbate congestive heart failure in some patients." The AP (2/7) noted that late last year, the "Justice Department and several state attorneys general" were investigating the "development and marketing of Avandia." A Senate investigation "released last year concluded that Glaxo knew about the risks of its drug years before they were made public and withheld important data from the FDA." NPR 's (2/7, Hensley) "Shots" blog reported, "In September, FDA Commissioner Margaret Hamburg predicted the number of people taking Avandia would decline dramatically from around 600,000 at the time. She was right." Glaxo told "Shots about 100,000 people in the US are taking Avandia these days."
Reported by the American Association for Justice
Combined Avastin, chemotherapy treatment linked to higher mortality risk
February 2, 2011
USA Today (2/2, Szabo) reports, cancer patients treated with a combination of the angiogenesis inhibitor Avastin [bevacizumab] and chemotherapy are "50-percent more likely to die from their treatment rather than their disease," according to a study in the Journal of the American Medical Association. According to Bloomberg (2/2, Cortez), "Deadly side effects occurred in 2.5 percent of patients given Avastin, and were 46-percent more common in those getting it in a mix of medicines rather than chemotherapy alone" in the meta-analysis of 16 clinical trials "involving 10,217 patients." The Wall Street Journal (2/2, Dooren, Mundy) reports the most common causes of death were hemorrhages, neutropenia, and perforations in the stomach or intestines. The AP (2/2, Johnson) points out that it is "still unclear which patients are most likely to benefit" from bevacizumab. "Deaths from Avastin's side effects are rare and the small risk should be weighed against the drug's possible benefits," said senior study author Dr. Shenhong Wu of Stony Brook University Cancer Center in New York. Charlotte Arnold, a spokesperson for Avastin's maker, Genentech, "said the new analysis is based on known information and includes studies in cancer types for which the drug isn't approved." She said the company "supports research to find biomarkers that might reveal which patients may respond to Avastin.
MedPage Today (2/1, Bankhead) noted that in an accompanying editorial, University of Michigan oncologist Daniel F. Hayes, MD, "said key to striking a risk-benefit balance with bevacizumab will be the identification of patients who are most likely to benefit. .... 'Bevacizumab works well, but only in selected patients,'" Dr. Hayes emphasized. HealthDay (2/1, Gardner) added that a lung cancer expert, Dr. Roman Perez-Soler of the Montefiore Medical Center in New York City, pointed out that "lung cancer is one of the few malignancies in which Avastin has prolonged survival and thus might still have a place in this armamentarium." Meanwhile, the Los Angeles Times (2/2, Forgione) "Booster Shots" blog notes that Avastin also "made news in December" when the FDA moved to "begin the process of withdrawing approval of Avastin as a treatment for breast cancer because the federal agency found no evidence that it extended the lives of women who had the disease." Genentech requested a "hearing appealing" the agency's proposed withdrawal; and the drug was "still approved for kidney, brain and lung cancers."
Reported by the American Association for Justice
Counterfeit drugs may be on the rise in US
February 17, 2012
The AP (2/16, Johnson) reports, "The discovery that a fake version of the widely used cancer medicine Avastin [bevacizumab] is circulating in the United States is raising new fears that the multibillion-dollar drug-counterfeiting trade is increasingly making inroads in the US" According to the AP, "the criminal practice has largely been relegated to poor countries with lax regulations" but "with more" drugs "in the US being manufactured overseas, American authorities are afraid more counterfeits will find their way into this country, putting patients' lives at risk." The fake bevacizumab "discovery follows other recent instances in the US of counterfeiting, involving such drugs as Viagra [sildenafil citrate], the cholesterol medicine Lipitor [atorvastatin] and the weight-loss" medication "Alli [orlistat]."
The Wall Street Journal (2/16, B1, Rockoff, Whalen, Weaver, Subscription Publication) reports injectable medications are increasingly become popular with counterfeiters because they command greater prices than regular drugs. Although the number of reports of fake injectable drugs is small, counterfeiting of these drugs has more than doubled to 4% during a four year span, according to the Pharmaceutical Security Institute. Because these injectable drugs are most often used for life threatening diseases such as cancer, many healthcare professionals are concerned.
Reported by the American Association for Justice
Study: New York hospitals violate rules about pursuing unpaid bills
February 15, 2012
In a front-page story, the New York Times (2/13, A1, Bernstein, Subscription Publication) reports that New York has "passed laws curbing hospitals' pursuit of unpaid bills," but "a new study of New York hospitals' practices and state records finds that most medical centers are violating the rules without consequences, even as the state government ignores glaring problems in the hospitals' own reports." The study, by the Community Service Society of New York, "found that some hospitals did not provide financial aid applications at all, and that many made impermissible demands for irrelevant documents or failed to supply key information, like eligibility rules for big discounts required by state law in 2007." New York "state's Department of Health acknowledges systemic problems, including the need for better reporting and enforcement, a spokesman, Michael Moran, said."
Reported by the American Association for Justice
Obama announces $26 billion foreclosure settlement
February 13, 2012
The foreclosure settlement announced led all three network news broadcasts last night, receiving an extraordinary amount of coverage -- nearly 15 minutes in total. Due to the complexity of the settlement itself, coverage last night and this morning focused more on its details than political or economic implications. Broadly speaking, however, the deal is being described as ambitious in scope and intent, but unlikely to restore the housing market in the near future. The President's remarks yesterday, as well as those from Administration officials, garner relatively little notice in this morning's print coverage.
Notably, NBC Nightly News (2/9, lead story), with the largest audience of any news program, focused on the perceived shortcoming of the deal, noting that "consumer groups and many experts say the banks got off easy." The AP (2/10, Kravitz) also says that although the settlement was "hailed by" the Administration, "consumer advocates countered that far too few people will benefit." According to the AP, "The deal will reduce loans for only a fraction of those Americans who owe more than their homes are worth," and the "checks" for those "who were improperly foreclosed upon...are modest. It's unclear how much the deal will help struggling homeowners keep their homes or benefit those who have already lost theirs." Similarly, USA Today (2/10, Schmit, Davidson) reports that the settlement "gives little immediate relief to the majority of US homeowners who are current on their home payments, and even less relief for homeowners who'll likely never end up with a distressed loan."
Brian Williams, at the opening of NBC Nightly News (2/9, lead story), said, "Aside from the enormous damage the foreclosure mess caused, a big complaint across this country continues to be nobody paid for it. Well, today the President announced a settlement between the Feds, state attorneys general and the nation's five largest banks to help distressed borrowers and struggling homeowners. The problem? Well, like so many other government plans, it's the details." NBC went on to report that "consumer groups and many experts say the banks got off easy. ... The five banks together earned more than $46 billion in profits last year, yet under the settlement, they have to pony up only five billion in hard cash." Susan Webber of Naked Capitalism: "The banks come out the big winners because the costs they are paying are very small in terms of the damages that were done."
McClatchy (2/10, Ordonez, Hall) says "the settlement effectively punishes the banks for alleged abuses in the foreclosure process, including robo-signing. ... About 1 million households at risk of foreclosure should be able to reduce their loans. Another 750,000 Americans who lost their homes to foreclosures will receive about $2,000 each." Nevertheless, McClatchy adds that "housing experts doubted...that the settlement the president described as a 'landmark' will have a broader impact on the struggling housing sector."
According to the Washington Post (2/10, Dennis, Horwitz), "The deal aims to help troubled borrowers by reducing the amount they owe on their mortgages, lowering their interest rates and paying restitution to homeowners who suffered mortgage-related abuses. It will force lenders to revamp how they interact with troubled homeowners and bar them from trying to foreclose on borrowers while simultaneously negotiating mortgage modifications. In addition, firms will have to make sure borrowers have a single point of contact with a lender, rather than being shuttled to different employees with each interaction."
Settlement does not preclude criminal charges or lawsuits. The Los Angeles Times (2/10, Popper, Reckard) reports the banks "previously made changes to improve the way they foreclose on homeowners," and, "until recently, analysts thought this might put to rest many of the largest complaints about the role the banks played in the financial crisis," but "it hasn't. There are a growing number of signals that prosecutors and regulators are stepping up efforts to bring new lawsuits and criminal charges in connection with the crisis. ... Authorities can still investigate various fraud claims, including those involving the mortgage bonds whose meltdown triggered a global financial crisis," an "what's more, there is no criminal immunity."
Reported by the American Association for Justice
FDA now says two lipsticks sold in US may have high levels of lead
February 8, 2012
The Forbes (2/8, Westervelt) reports, "In 2007, largely in response to a report released by the Campaign for Safe Cosmetics, the FDA began testing various lipsticks sold in the United States," with "FDA scientists" concluding "that none of them contained unsafe levels of lead." However, about two months ago, the agency "updated its tests and posted the results on its website rather quietly," now saying that lead levels in "two brands (Maybelline and L'Oreal) with lipsticks above California's standard" of 5 parts-per-million.
Reported by the American Association for Justice
Company recalls eggs over listeria contamination
February 6, 2012
In continuing coverage, the AP (2/6) reports that Michael Foods, based in Minnesota, "said Friday it is recalling more than a million hard-cooked eggs distributed to 34 states after testing revealed some may be contaminated with listeria. ... The US Food and Drug Administration said the eggs were produced at the company's plant in Wakefield, Neb., and were bought by food distributors and manufacturers and not sold directly to retailers. There have been no reports of illness connected to the eggs, the agency said."
Reported by the American Association for Justice
Drug shortages force patients to miss chemotherapy, switch to other medications
February 6, 2012
The Shreveport Times (LA) (2/4, Tyrrell) reports, "With 230 drugs reported in short supply this past year, cancer patients have been forced to miss chemotherapy treatments and switch to other medicines with more side effects." Legislation recently unveiled by Rep. John Carney (D-DE) seeks to keep the "drug shortage problem from getting worse." The Times adds, "Dr. Stephen Grubbs, an oncologist at Christiana Care's Helen F. Graham Cancer Center, said when he checked" an FDA list of drug shortages "Tuesday, '95 percent' of the 50 sterile injectible drugs on it were generic." Dr. Grubbs said, "Anything we can do to alleviate this problem will be best for patients."
Reported by the American Association for Justice
House report indicates tanning-salon business "built on deception"
February 06. 2012
ABC World News (2/1, story 8, 2:25, Sawyer) reported, "There are more tanning salons in America than there are Starbucks. It is a huge, booming business. But some members of Congress warned today that it is also built on massive deception." ABC News correspondent Jim Avila explained that "nearly two years ago, the FDA's own experts, along with pediatricians and dermatologists, recommended a ban on indoor tanning for minors. But the tanning lobbyists have spent nearly $500,000 since, defending the industry's health claims. And, so far, no FDA action," despite the fact that "there is no safe indoor tan."
The National Journal (2/2, Sanger-Katz, Subscription Publication) reports, "A secret-shopper study by House Democratic staffers found that tanning-salon employees routinely lied about the risks of indoor tanning, and frequently provided misleading information suggesting that tanning had health benefits." The investigative report, "commissioned by the Energy and Commerce Committee minority staff, involved interviews with 300 salons around the country." The study found that "salons routinely gave inaccurate information," with some 90% saying that tanning posed no risks to health.
The "On Deadline" blog of USA Today (2/2, Bacon) notes that the staff study cites American Academy of Pediatrics warning that indoor tanning beds are "generally unsafe for children," recommending they be banned for kids under 18. On its website, CBS News (2/2, Cordes) points out that the "risk of melanoma goes up 75 percent when tanning bed use begins before the age of 30."
Reported by the American Association for Justice
GlaxoSmithKline agrees to settle 20,000 suits over Avandia
February 6, 2012
Bloomberg News (2/2, Feeley) reports, "GlaxoSmithKline Plc which is paying $3 billion to resolve government claims that it illegally marketed drugs such as the Avandia diabetes medication, agreed to settle more lawsuits over the pills, a lawyer said." Bloomberg adds, "Glaxo, the UK's biggest drugmaker, agreed last month to resolve more than 20,000 cases alleging Avandia causes heart attacks, said Paul Kiesel, a lawyer for former users. The accord, reached in court-ordered mediation, included a case that was set for trial in state court in Los Angeles, he said."
Reported by the American Association for Justice
New websites streamline data on drugs, medical devices
January 31, 2012
In her Wall Street Journal (1/31, Subscription Publication) column, Melinda Beck writes, the US Food and Drug Administration has an abundance of information on "adverse event" reports for many prescription medications but that information was not easily accessible until recently. One start up company called AdverseEvents Inc has gathered information from the FDA's database so an individual can search its website for adverse event reports for some 4,500 medications. A second start up, called Clarimed LLC, also compiled data from the FDA, but its database is on 130,000 medical devices. Both companies launched their online websites back in September to help empower patients.
Reported by the American Association for Justice
Experts predict extinction of health insurance companies
January 31, 2012
Former Obama Administration advisors Ezekiel J. Emanuel and Jeffrey B. Liebman predict in a piece for the New York Times (1/31) Opinionator that "by 2020, the American health insurance industry will be extinct. Insurance companies will be replaced by accountable care organizations -- groups of doctors, hospitals and other health care providers who come together to provide the full range of medical care for patients." The writers argue that "accountable care organizations will...shift the focus of medicine away from treating sickness and toward keeping people healthy." They also note that some "health insurers see this asteroid coming" and are buying or developing services to become involved "in the new world of coordinated care."
Reported by the American Association for Justice
Drug shortage puts pharma companies on "hot seat"
January 30, 2012
The St. Paul Pioneer-Press (1/39, Snowbeck) reported, "Drug shortages are putting pharmaceutical companies on the hot seat. Last week, medical-products giant Johnson & Johnson assured shareholders that it is doing everything possible to resolve a shortage of a chemotherapy drug called Doxil [liposomal doxorubicin], which is used by patients with ovarian and other sorts of cancer." Though the company said the liposomal doxorubicin shortage probably won't be resolved until much later this year. One "survey conducted by the American Society of Health System Pharmacists" found "that hospital pharmacists are spending 8 to 12 additional hours per week dealing with shortages, work that costs the health care system about $216 million a year."
Patients unable to fill prescriptions due to shortages. The Duluth (MN) News Tribune (1/28, Lundy) reported, "The shortage of Adderall [dextroamphetamine/amphetamine], Ritalin [methylphenidate] and similar drugs has been playing out nationwide for months. It peaked in the fall after first surfacing in May, said Erin Fox, manager of the University of Utah's Drug Information Service, which tracks drug availability nationwide for the Food and Drug Administration." What's more, the shortage "has been more acute for Adderall, which is a composite of three kinds of amphetamine salts, because it has fewer manufacturers than Ritalin." The Tribune adds, "Sen. Amy Klobuchar, D-Minn., who is author of legislation to address drug shortages, said the number of drugs with shortages rose from 55 in 2005 to 231 last year."
Reported by the American Association for Justice
Editor says tort-reform law hasn't benefitted Texas
January 26, 2012
The managing editor of the Henderson (TX) Daily News (1/23, Floyd) wrote in commentary, "Texas may not have been the first state to welcome tort reforms but I can't imagine anyone embracing it with such wild enthusiasm as Texans over the past 20 years or so." He adds that in his failed presidential campaign, Gov. Rick Perry "perpetuated the myth that implementing Texas-style tort reforms would go a long way toward curing what's wrong with the healthcare system." Noting that malpractice insurance premiums dropped after the state enacted curbs on non-economic damages awards, the author notes that the state's post-enactment doctor-population ratio fell to nearly the bottom of the states. In fact, he says, Texans "would be hard pressed to claim any direct benefit -- except, that is, for Texans who are doctors. Medical liability premiums have declined by nearly 30 percent since tort reforms were enacted."
Reported by the American Association for Justice
Five biggest US banks agree to $25 billion foreclosure settlement
January 26, 2012
The CBS Evening News (1/23, story 2, 1:50, Pelley) reported, "The nation's five largest banks have agreed to a settlement that may end one of the most painful chapters in the collapse of the housing market. Eight million American homeowners have gone through foreclosure -- some of them were hauled into banks that cut corners and used fraudulent documents. Under the terms of this proposal a million Americans may get help to stay in their homes." CBS added, "Major mortgage lenders would agree to pay $25 billion, money that would be used to reduce principal for roughly a million troubled borrowers; 750,000 would also receive checks for $1,800."
Liberal groups unhappy with proposed settlement. The Washington Post (1/24, Dennis) reports, "Liberal activists and consumer advocates [were] insisting that the president is settling too soon, for too little. Those complaints surfaced again Monday as US Department of Housing and Urban Development Secretary Shaun Donovan, top Justice Department official Tom Perrelli and Iowa Attorney General Tom Miller gathered in Chicago to brief Democratic state attorneys general on the outlines of the agreement and to shore up support."
The Hill (1/24, Needham) reports in its "On The Money" blog, "Sen. Sherrod Brown (D-Ohio) and Rep. Brad Miller (D-N.C.) along with several other advocates on Monday said a proposed settlement of upward of $25 billion between federal and state governments and the nation's five largest banks is wholly inadequate and ambiguous as to which homeowners it will help. Meanwhile, Maryland Democrat Elijah Cummings, ranking member of the House Oversight and Government Reform Committee, sent a letter to Chairman Darrell Issa (R-Calif.) asking him to bring high-ranking executives from the nation's biggest mortgage banks to Capitol Hill testify about foreclosure abuses."
The Wall Street Journal (1/24, Simon, Nicas, Timiraos, Subscription Publication) reports that the proposed deal is the result of nearly a year of discussions between federal and state officials and Ally Financial Inc., Bank of America Corp., Citigroup Inc., J.P. Morgan Chase & Co. and Wells Fargo & Co.
Reported by the American Association for Justice
Witness: J&J hid studies showing users of Risperidone developed diabetes
January 19, 2012
Bloomberg News (1/19, Feeley, Cronin Fisk, Voreacos) reports, "Johnson & Johnson officials hid three studies showing some users of its Risperdal [risperidone] antipsychotic drug developed diabetes while claiming the medicine didn't cause the disease, a witness testified." Joseph Glenmullen, a psychiatrist and Harvard Medical School instructor, told a Texas jury, "As early as 1999, Johnson & Johnson's Janssen unit had researchers' findings that about half the patients taking Risperdal in a study comparing its risks to those of Eli Lilly & Co.'s Zyprexa [olanzapine] antipsychotic drug developed diabetes after a year on the medication." Glenmullen added, "At the same time, Janssen salespeople were telling doctors researchers concluded the drug didn't cause the disease."
Witness says J&J's marketing may have violated agreement. Bloomberg News (1/19, Feeley, Cronin Fisk, Voreacos) reports, "A Johnson & Johnson unit's marketing of its Risperdal antipsychotic drug to doctors treating mentally ill children may have violated the drugmaker's agreement with Texas, a state official testified." Billy Milwee, the state Medicaid director, explained to a jury today that "a push by J&J's Janssen unit to increase Risperdal prescriptions for children and adolescents before 2006 may have broken the drugmaker's promises to 'comply with all state and federal laws' in exchange for having the drug covered by the Texas Medicaid program." Bloomberg News points out that "the US Food and Drug Administration didn't approve Risperdal for any pediatric use until 2006."
Reported by the American Association for Justice
Witness tells jurors J&J marketed Risperidone for children despite FDA warnings January 18, 2012
In continuing coverage, Bloomberg News (1/14, Voreacos, Fisk, Feeley) reported, "The antipsychotic drug Risperdal was marketed for children and adolescents by Johnson & Johnson's Janssen unit after warnings by the US Food and Drug Administration not to do so, a witness told jurors." Arnold Friede, an expert witness for the state, "explained company documents and FDA letters as lawyers for Texas seek to show Janssen repeatedly disregarded agency admonitions to not market Risperdal beyond its initial approved use for psychotic disorders including schizophrenia." The company's "marketing to children began after the drug's introduction in 1994 and continued until the FDA's first approval for pediatric uses in 2006," Friede stated. The case is Texas v. Janssen LP, D-1GV-04-001288, District Court, Travis County, Texas (Austin).
Reported by the American Association for Justice
J&J trial hears from former Texas official paid to promote anti- psychotic drug
January 16, 2012
In continuing coverage, Pharmalot (1/12, Silverman) reports on the whistleblower trial in Austin of whether Johnson & Johnson's Texas Medication Algorithm Project defrauded Texas by boosting use of its Risperdal antipsychotic. A former Pennsylvania state investigator originally filed the suit in 2004; Texas joined it in 2006. The trial earlier this week saw videotaped testimony from Steve Shon, a former medical director of behavioral health at the Department of State Health Services, who "was paid to speak to officials in other states about TMAP guidelines that J&J purportedly hoped would be used as a protocol for prescribing antipsychotic drugs, notably Risperdal." The Texas attorney general "is arguing the payments to Shon -- which totaled nearly $48,000 over several years -- were part of a plan to influence guidelines."
Bloomberg News (1/13, Voreacos, Fisk, Feeley) adds that in the third day of the trial, whistleblower Allen Jones testified that "he was an investigator in the Pennsylvania Office of Inspector General in 2002 when he looked into an unregistered bank account" of a state pharmacist on a Pennsylvania committee that advised whether the state should use newer, more expensive drugs like Risperdal in state-funded treatment of mental-health patients. Jones said that he discovered the account "was used to deposit money from drug companies." Texas claims that its Medicaid program overpaid at least $579 million for Risperdal.
Reported by the American Association for Justice
FDA: J&J continued to sell insulin pumps after discovering defects
January 11, 2012
Bloomberg News (1/11, Nussbaum) reports on word from the FDA that "Johnson & Johnson's Animas unit kept selling insulin pumps last year after learning of malfunctions with the devices that prompted it to make design changes." The problems "with Animas' One Touch Ping and 2020 pumps prompted a company investigation that started in April, according to" an FDA "letter, which was dated Dec. 27." The December "warning could lead to fines or affect J&J's chances of winning federal contracts, the agency said in the letter."
Reported by the American Association for Justice
FDA issues order for surgical mesh makers to study product's risks
January 6, 2012
The New York Times (1/5, B4, Meier, Subscription Publication) reports, "The Food and Drug Administration issued an order on Wednesday requiring makers of implantable surgical mesh used to treat urinary incontinence in women to study its risks." This "move comes after years of reports of serious injuries linked to the devices, including infections, pain and other complications." In addition, "it follows a recommendation in September by an FDA advisory panel that the agency require such studies."
"The FDA said in an online post that 33 manufacturers of medical mesh would be required to submit follow-up safety studies to the agency," the AP (1/5) reports. "Manufacturers include Johnson & Johnson, Boston Scientific Corp. and CR Bard." Currently, the agency "is considering reclassifying the mesh as a high-risk device, so that manufacturers would have to prove the product's safety and effectiveness before it could launch. The reclassification could take years," the AP points out.
According to Bloomberg News (1/5, Nussbaum, Voreacos), "Almost 300,000 synthetic meshes were implanted in US women in 2010 to treat incontinence or shore up pelvic muscles, the agency estimates." To date, "the devices' alleged failures have spurred more than 650 lawsuits against manufacturers and heightened scrutiny of the FDA program that cleared the products for sale without human testing." Now, letters from the FDA "ask each manufacturer to collect data on the results and potential complications of transvaginal procedures, in which the hammock-like meshes are threaded in place through an incision in the vagina."
Reported by the American Association for Justice
Short supply of ADHD medications has patients worried
January 3, 2012
The New York Times (1/1, A1, Harris, Subscription Publication) reported in a front-page story, "Medicines to treat attention deficit hyperactivity disorder are in such short supply that hundreds of patients complain daily to the Food and Drug Administration that they are unable to find a pharmacy with enough pills to fill their prescriptions." The Times said that "the shortages are a result of a troubled partnership between drug manufacturers and the Drug Enforcement Administration, with companies trying to maximize their profits and drug enforcement agents trying to minimize abuse by people."
"Shortages have become so endemic -- particularly of cheaper generics -- that some patients say that they suffer almost constant worry that they will not get enough," the New York Times (12/31, O'Connor) "Well" blog reported. Many "drug manufacturers have announced that their medicines are in short supply" and "the Food and Drug Administration lists the drugs as being in short supply on its official drug shortages list." In addition, "the American Society of Health-System Pharmacists, which tracks drug shortages for hospitals, lists the medicines as being in short supply."
The Boston Globe (1/1, Harris) reported that the "American Academy of Child and Adolescent Psychiatry has told its members that shortages seem to be 'widespread across a number of states" and are 'devastating' for children."
Reported by the American Association for Justice
ADHD medications may not increase cardiovascular risks in adults
January 3, 2012
The Washington Post (1/2, Searing) reported that a study, published online Dec. 12 in the Journal of the American Medical Association, "analyzed data on 443,198 adults, 25 to 64 years old, including 150,359 who took ADHD medications, mainly Ritalin (methylphenidate) or Adderall (amphetamine) but also Strattera (atomoxetine) or Cylert (pemoline)." The researchers found that "in about a two-year period, 1,357 heart attacks, 575 strokes and 296 sudden cardiac deaths were recorded" but "the cardiovascular problems occurred at virtually the same rate among people who took ADHD medications and those who did not, regardless of people's age, how long they had been taking the medication or which drug they took." However, some limitations of the study were that "data came from electronic records of filled prescriptions; consumption of medication was not verified" and "the study did not determine whether dosage made a difference or whether use of the medications contributed to less severe cardiovascular problems."
Reported by the American Association for Justice
Group warns against using "anti-aging" interventions
December 30, 2011
CNN /Health.com (12/28, Voss) reported that recombinant human growth hormone (HGH) is "a synthetic version of a pituitary hormone hawked as a miraculous fountain of youth," even though "the US Food and Drug Administration (FDA) warns that taking HGH poses serious health risks." Use of HGH has been associated with an increased risk for cancer, for example. "Aging is a natural process, not a medical condition, and there isn't any therapy that can reverse it or slow it down," according to S. Jay Olshansky, PhD, of the Center on Aging at the University of Chicago. "Official medical associations from the Endocrine Society to the American Medical Association warn against using 'anti-aging' interventions."
Reported by the American Association for Justice
Seven LCD manufacturers to settle price-fixing lawsuits for $553M
December 28, 2011
The AP (12/27) reported, "Seven companies based in Asia will pay $553 million to settle claims by officials in eight states that they conspired to inflate prices for liquid crystal display screens used in televisions and computer monitors, New York Attorney General Eric Schneiderman said Tuesday." The deal "provides $501 million for partial refunds for consumers in 24 states and the District of Columbia who purchased products with the companies' LCD panels from 1999 through 2006."
Andrea Chang wrote in a Los Angeles Times (12/27) blog posting, "The companies -- Chimei Innolux Corp., Chunghwa Picture Tubes Ltd., Epson Imaging Devices Corp., HannStar Display Corp., Hitachi Displays Ltd., Samsung Electronics Co. and Sharp Corp., and their US affiliates -- agreed to pay more than $538 million to settle antitrust claims brought on behalf of consumers, government entities and other public entities by a group of eight attorneys general and private class-action attorneys, according to the New York attorney general's office." In addition, "five of the tech companies agreed to pay more than $14 million to settle other claims brought by the states in their law enforcement capacities."
Reported by the American Association for Justice
Target recalls 139,000 children's suitcases over high levels of lead
December 23, 2011
The AP (12/22) reported, "Target Corp. and the US Consumer Product Safety Commission on Thursday announced a recall of some children's suitcases because they violate federal lead paint standards." Some "139,000 of the Circo 17-inch suitcases, which were manufactured in China, were sold exclusively at Target stores between April and August for about $21." According to the CPSC, "the suitcase's surface coating contains 'excessive levels' of lead that violate the government's lead paint standard." So far, there have no reports of injuries.
Reported by the American Association for Justice
DoJ announces largest-ever settlement of lending fraud charges with BoA
December 23, 2011
Attorney General Eric Holder's announcement on Wednesday that the Justice Department has settled discrimination charges against the now-defunct mortgage lender Countrywide generated significant print and television coverage, including five minutes of coverage on network newscasts. Nearly all the coverage notes that the settlement, in which Bank of America, which took over Countrywide in 2008, will pay $335 million, is the largest ever of its kind. NBC Nightly News (12/21, story 4, 0:35, Williams) reported, "The Justice Department announced today it has settled lending discrimination charges against the defunct mortgage lender Countrywide which steered black and Hispanic borrowers into subprime loans even when they qualified for prime mortgages. Then they charged higher fees and rates to more than 200,000 minority borrowers."
Reported by the American Association for Justice
FDA renews warning on ShoulderFlex Massager
December 23, 2011
The Boston Globe (12/21, Kotz) reported, "If you own a ShoulderFlex Massager, get rid of it, said the US Food and Drug Administration in a warning issued" on Wednesday. This "device -- which delivers a deep tissue massage to the neck, shoulders, and back while you're lying down -- was recalled last August after it killed one user and resulted in the near-strangulation of another." Nevertheless, the FDA "is concerned that the now bankrupt company, King International, didn't do a good enough job recalling the product before it went out of business."
NPR (12/21, Hensley) noted in its "Shots" health blog that the new alert warns that a recent compliance audit shows that King International went out of business before completing the recall. FDA found that the toll-free number set up for the recall was no longer in service, and that almost 12,000 of the massagers have been distributed in the US since 2003.
MSNBC in its "Vitals" blog (12/21, Dahlstrom) added that a "quick Internet search reveals that the product is still available at several online web sites" and recalls that it was responsible for the strangulation death of Dr. Michelle Ferrari- Gegerson, "a 37-year-old Florida woman, was found dead by her husband last Christmas Eve after her leather necklace got tangled in the device."
Reported by the American Association for Justice
FDA says patients with permanent atrial fibrillation should not use dronedarone
December 20, 2011
The AP (12/19, Perrone) reported, "Federal health officials said Monday they have added new safety warnings to the heart rhythm drug Multaq [dronedarone], after a company study by Sanofi linked the tablet to higher rates of heart attack, stroke and death in a subset of patients." According to the AP, "the boxed warning highlights the results of a study in which Multaq doubled the risk of heart-related complications in patients with permanent atrial fibrillation." The new "label stresses that Multaq is only approved for the short-term form of the condition and a related ailment known as atrial flutter." The Wall Street Journal (12/19, Burton, Subscription Publication) reported that earlier this year, the agency requested that the company add to the medication's label that "liver injury, including acute liver failure requiring transplant, has been reported in patients treated with Multaq."
Reported by the American Association for Justice
FDA requires warning on Boston Scientific stent
December 20, 2011
Reuters (12/16, Sherman) reported that the Food and Drug Administration has approved the Boston Scientific Corp. Promus Element heart stent but is requiring that the company warn doctors about a rare but serious problem. The agency says that the stent, like competing ones made by Medtronic Inc. and Abbott Laboratories may become deformed after implantation. Ashley Boam, director of FDA's division of Interventional Cardiology Devices Branch, says that the "longitudinal stent deformation" may be due to the stents very thin struts, which make the device more flexible and thus implantable in narrow or hard-to-reach blood vessels. The agency has required the company to include a section on the issue on the company's 20-page label, describing the problem and where it most often occurs, and providing guidance and suggesting techniques to minimize problems.
Reported by the American Association for Justice
Insurance industry accused of making huge profits by delaying claims
December 15, 2011
The Huffington Post (12/13, Reilly) reported, "Unlike many other businesses, the insurance industry is bound by law to act in good faith with its customers." Insurance companies were considered "semi- public-trusts." Yet, that changed in the 1990s when their focus shifted from service to profit making. Allstate is credited with originating this trend by adopting a plan crafted by consulting firm McKinsey & Company. The strategy was simple: "Rather than adjusting claims the traditional way, which gave claims managers wide latitude to serve customers, insurers embraced a computer-driven method that produced purposefully low offers to claimants." Customers who accepted "low-ball offers" had their claims processed quickly, while those who refused were forced to wait. "As former Allstate agent Shannon Kmatz told the American Association for Justice, the trial lawyers' lobby, the strategy was to make claims 'so expensive and so time-consuming that lawyers would start refusing to help clients.'"
Reported by the American Association for Justice
FDA accuses 1-800-GET THIN centers of misleading customers
December 14, 2011
The AP (12/13) reported that officials with the Food and Drug Administration "have issued warning letters to eight surgical centers and a marketing firm in California for misleading advertisements promoting the Lap-Band, a stomach-restricting device used to treat obesity." Yesterday, the agency said in a news release "that advertisements by the centers and a marketing firm, 1-800-GET-THIN, do not provide mandatory information about the risks and side effects of Lap-Band implantation. The stomach-restricting band -- made by Irvine, Calif.-based Allergan Inc. -- limits food intake, but can also cause irritation of the esophagus, infection, nausea and vomiting in some cases."
Reported by the American Association for Justice
Risk of broken wheels prompts Ford to recall 129,000 Fusions and Mercury Milans
December 12, 2011
Christopher Jensen wrote in a New York Times (12/9) blog posting that "Ford is recalling almost 129,000 of its 2010-11 Ford Fusions and Mercury Milans because the wheel studs on vehicles equipped with 17-inch steel wheels could break, potentially leading to a wheel coming loose and falling off." The company "told the National Highway Traffic Safety Administration of the recall in a report (PDF) filed Friday on the agency's Web site."
Chris Woodyard wrote in a USA Today (12/9) blog posting that the "recalled vehicles were built April 1 through April 30, 2009, and Dec. 1, 2009 through Nov. 13, 2010." People who own affected vehicles "will be notified the week of Jan. 24. Dealers will inspect the rear brake disc surface and replace the discs at no charge if necessary."
Bloomberg News (12/9, Plungis) quoted Ford spokeswoman Susan Krusel as saying, "Affected customers can continue to drive their vehicles. ... We are not aware of any accidents or injuries." Reuters (12/9) also covered the story.
Reported by the American Association for Justice
FDA, FTC warn companies to stop selling homeopathic diet products
December 8, 2011
The AP (12/6) reported that the Food and Drug Administration issued warning letters to seven companies, ordering them "to stop selling an unproven weight loss remedy that uses protein from the human placenta." The FDA has approved human chorionic gonadotropin (hCG), produced by the placenta and found in the urine of pregnant women, for certain infertility treatments, but says there is no evidence that it is effective for weight reduction. Sold as drops, pellets or sprays, HCG is often marketed as boosting low-calorie dieters' weight loss, but Elizabeth Miller, of FDA's division for non- prescription drugs and health fraud, said that "the data simply does not support this -- any loss is from severe calorie restriction. Not from the HCG." It also notes that hCG is not on the FDA's list of approved ingredients for homeopathic remedies.
Reported by the American Association for Justice
House Democrats request hearing from pharmaceutical firms on shortages
December 4, 2011
CQ (12/1, Norman, Subscription Publication) reported, "House Democrats on Thursday asked for a hearing with drugmakers following a Wednesday hearing at which medical and pharmaceutical experts discussed the impact of prescription medicine shortages. The next logical step in an investigation of shortages is to call in manufacturers who are experiencing them," said Elijah E. Cummings of Maryland and Danny K. Davis of Illinois. The following "hearing should include Bedford Laboratories, APP Pharmaceuticals, Hospira, Teva Pharmaceuticals and Sandoz Pharmaceuticals, they said, all manufacturers of drugs on the Food and Drug Administration shortage list."
Reported by the American Association for Justice
GM promises to buy back Volts from owners concerned about fire hazard
December 4, 2011
The AP (12/1) reported, "General Motors will buy Chevrolet Volts back from any owner who is afraid the electric cars will catch fire, the company's CEO said Thursday." During "an exclusive interview with The Associated Press, CEO Dan Akerson insisted that the cars are safe, but said the company will purchase the Volts because it wants to keep customers happy." He "said that if necessary, GM will recall the more than 6,000 Volts now on the road in the US and repair them once the company and federal safety regulators figure out what caused the fires."
The New York Times (12/1, B4, Vlasic, Bunkley, Subscription Publication) reported, "Such a buyback is unusual for car companies, which typically institute recalls when regulators or customers report problems with cars or parts." Notably, the "Volt has come under scrutiny after the National Highway Transportation Safety Administration said on Nov. 25 that it had opened a defect investigation into the car's 400-pound battery pack."
The Financial Times (12/1, Simon, Subscription Publication) noted the comments by GM's CEO, but points out that the results of the National Highway Traffic Safety Administration's investigation into the cause of the fires could adversely affect the market for electric cars, which are being touted as a replacement for fuel vehicles. So far, most major car manufacturers intend to build electric vehicles, and this incident could hinder those plans. Reuters (12/1, Klayman, Ingrassia) also covered the story.
Reported by the American Association for Justice
Critics slam overmedication of foster kids
December 4, 2011
ABC World News (12/1, story 4, 4:05, Sawyer) reported that an ABC News "one-year investigation into foster care children" revealed that "so many of them [are] overmedicated with multiple, powerful mind-altering drugs, often used for disorders the children don't have. Critics say it is happening because of kind of an unholy convergence: Our taxpayer Medicaid dollars pay for the drugs, the pharmaceutical companies see a market, and a lot of times, doctors can move through many patients fast." ABC News correspondent Sharyn Alfonsi added that "some states have now started requiring a second opinion by a doctor before some medication is dispensed." Florida is "now kicking high prescribing doctors out of the Medicaid program. Still, critics say too many foster care children are being pushed through the system...with pill after pill."
Reported by the American Association for Justice
Takeda could face thousands of lawsuits over Actos' alleged cancer link
December 4, 2011
Bloomberg News (12/1, Feeley) reported, Takeda Pharmaceutical Co. "may face as many as 10,000 lawsuits in US courts over allegations that its Actos [pioglitazone] diabetes drug causes bladder cancer, and a group of judges is preparing to decide where they should be consolidated." Several months ago, "US regulators found...that an analysis of a company-sponsored study showed some users of Actos, the world's best-selling diabetes medication, faced an increased risk of developing the potentially fatal disease." Bloomberg News adds, "The evidence linking Actos to bladder cancer "is unusually strong and clear," Paul J. Pennock, a New York-based lawyer representing former users of the drug, said in a telephone interview."
Reported by the American Association for Justice
Lawmakers seek answers to national medication shortage
December 1, 2011
CQ (11/30, Bristol, Subscription Publication) reported, "Chemotherapy drug shortages could increase medical errors and force physicians to ration care, medical and pharmaceutical experts told House subcommittee members Wednesday." Experts "recommend development of contingency plans for critical drugs for which there is only one manufacture or been stockpiling of some drugs" and also "recommended changes to the reimbursement system, including increasing Medicare payments for generics after several years to create more incentives for manufacturers." Witnesses also want Congress to "pass pending legislation which would require manufacturers to confidentially notify FDA when they experience production problems or discontinue a problem (HR 2245, S 296)."
Modern Healthcare (11/30, Zigmond, Subscription Publication) reported that the House Oversight and Government Reform Committee's health subcommittee heard witnesses testify "about the causes that have led to a shortage of life-saving drugs." Dr. Kasey Thompson, vice president of policy, planning and communications for the American Society of Health-system Pharmacists, "testified that while Medicare reimbursement policies may be partially to blame, his group's analysis shows that quality issues in the manufacturing process pose an even greater problem."
Reported by the American Association for Justice
Inspectors: Medicare should stop use of antipsychotics in nursing home patients
December 1, 2011
The AP (11/30, Perrone) reported, "Government inspectors told lawmakers Wednesday that Medicare officials need to do more to stop doctors from prescribing powerful psychiatric" medications "to nursing home patients with dementia, an unapproved practice that has flourished despite repeated government warnings." The antipsychotic medications are prescribed to treat "people suffering from schizophrenia and bipolar disorder, but they're also given to hundreds of thousands of elderly nursing home patients in the US to pacify aggressive behavior related to dementia." But these medications "can also increase the risk of death in seniors, prompting the Food and Drug Administration to issue multiple warnings against prescribing the drugs for dementia."
"Nursing homes should be held accountable for inappropriately dispensing antipsychotic" medications "for Medicare beneficiaries and pay back the Part D program for those misused medicines, Department of Health and Human Services Inspector General Daniel Levinson said Wednesday," CQ (11/30, Bristol, Subscription Publication) reported. "The Centers for Medicare and Medicaid Service (CMS) is emphasizing non-pharmacological interventions for patients who did not have a diagnosis of psychosis or might not be candidates for the drugs." Patrick Conway, chief medical officer and director for the CMS Office Clinical Standards and Quality, stated that "in addition to improving education for providers, prescribers and patients' families, the agency is strengthening current rules and eliminating conflicts of interest that may influence prescribing."
Bloomberg News (11/30, Wayne) reported, "Medicare improperly paid about $116 million in the first half of 2007 for prescriptions filled in nursing homes for a class of drugs called atypical anti-psychotics, Daniel Levinson told the Senate Committee on Aging in a hearing today." The "anti-psychotics include AstraZeneca PIc (AZN)'s Seroquel and Ei Lilly & Co. (LLY)"s Zeprexa.
Reported by the American Association for Justice
Study: Failure to notify patients of test results main reason for malpractice suits
November 29, 2011
The Washington Post /Kaiser Health News (11/28, Andrews) reported that a new "study in the Journal of the American College of Radiology found that annual medical malpractice payouts for communication breakdowns, including failing to share test results, more than quadrupled nationally between 1991 and 2010, to $91 million." In order to reach this conclusion, researchers analyzed "medical malpractice claims from 425 hospitals and 52,000 providers." They found that "of the 306 cases in which test results were specifically cited as a factor in a malpractice case, the most common problem - it occurred almost half the time - was that the patient didn't receive the test results." Failure to notify clinicians of test results was also another major problem
Reported by the American Association for Justice
Archdiocese of Chicago agrees to settle sexual abuse case for $3.2M
November 16, 2011
The AP (11/15) reported, "Attorneys for a victim of convicted pedophile and former Roman Catholic priest Daniel McCormack have reached a $3.2 million settlement with the Archdiocese of Chicago and Cardinal Francis George. Chicago-based law firms Hilfman & Martin and Abels & Annes announced the agreement Tuesday." McCormack admitted to having abused five children. This particular "victim was 10 to 12 years old during the abuse."
Reported by the American Association for Justice
FDA urged to issue more alerts about drug risks
November 16, 2011
The New York Times' "Prescriptions" blog (11/15, Japsen) reported that FDA efforts "to issue 'safety signals' when it is alerted to potential health risks of prescription drugs isn't working well to notify the public or guide doctors to alternative medicines, new research indicates." In a short online article published Monday in The Archives of Internal Medicine, two doctors of pharmacy wrote that about "half of the potential 'safety signals' about adverse events" listed on the FDA's website from 2008 through 2010 "resulted in labeling changes, but most were listed in an 'updated Warnings and Precautions section' without guidance as to what action should be taken." They urged revision of the postings to better highlight potential safety indications, stating healthcare professionals and consumers are advised against taking action on listed potential safety signals, even though they indicate serious risk. CDER doctors noted the FDA is working to improve drug safety surveillance and analysis.
Reported by the American Association for Justice
Toy-related injuries, deaths remain high despite new safety rules
November 16, 2011
USA Today (11/15, O'Donnell) reported, "Toy recalls have been declining since a tough new product-safety law was enacted in 2008, which regulators say shows consumers should be more confident than ever this holiday season." Data show 34 toys were recalled "in the 2011 fiscal year, ended Sept. 30, down from 172 in 2008." But, a new "Consumer Product Safety Commission report...shows toy-related deaths of kids younger than 15 increased last year, and injuries remain alarmingly high, says CPSC Chairman Inez Tenenbaum." There were 17 toy- related child deaths last year, an increase from 12 in 2010. In addition, the number of children treated at ERs for toy-related injuries remained the same as in previous years.
Reported by the American Association for Justice
U.S. Supreme Court Agrees to Hear Indianapolis Homeowners’ Appeal in Suit against City for Unequal Treatment in Collection of Sewer Tax
November 15, 2011
The Supreme Court of the United States has granted a petition for certiorari in the case of the Christine Armour v. City of Indianapolis. The plaintiffs in the case are homeowners of 31 properties who contend that they were treated unfairly, and in violation of the U.S. Constitution, when the City forgave the sewer tax assessment for all homeowners in their subdivision who were paying in installments but granted no forgiveness or refund to the plaintiff homeowners who had paid in one lump sum. They were stuck with paying the full assessment.
In 2004, the City had assessed each property $9,278 for a sanitary sewer project in the Northern Estates subdivision. The following year, the Indianapolis Board of Public Works decided to change the way it financed sewer projects and while doing so, adopted a policy which forgave 90% or more of the sewer assessments to the residents of Northern Estates who had elected to pay in installments. The Board, however, denied any forgiveness to those homeowners who had paid in one lump sum which resulted in the lump sum payers being out of pocket the full amount of $9,278 while many of their neighbors paid only $309 for exactly the same benefit.
In December of 2009, the Indiana Court of Appeals concluded that this differing treatment of identically situated homeowners violated the Equal Protection Clause of the U.S. Constitution.The City of Indianapolis was ordered to pay back $8,968 to the homeowners in addition to paying interest and attorneys’ fees. The case then moved to the Indiana Supreme Court, where the majority ruled in favor of the City, reversing the judgment in a 3-2 decision in May of 2011. Now, the U.S. Supreme Court has decided to take up the issue.
Ron Waicukauski, one of the attorneys for the homeowners, commented: “The Supreme Court only accepts about one case out of a hundred. We’re thrilled that they’ve granted our petition and we are hopeful the Court will act to correct the injustice that occurred when the City forgave the installment payers but refused to extend forgiveness to the homeowners who had paid in full.” The case is expected to be heard by the U.S. Supreme Court during February 2012.
Price Waicukauski & Riley, LLC, of Indianapolis, focuses on complex plaintiff’s litigation and has represented the plaintiffs during the several years of this litigation. In the Supreme Court, the plaintiffs are also being represented by Roy Englert and Mark Stancil of Robbins, Russell, Englert, Orseck, Untereiner & Sauber LLP of Washington, D.C., a firm with a specialty in Supreme Court Practice.
Source: Press Release and IndyStar
SCOTUS expected to announce it will hear challenge to healthcare law
November 14, 2011
A front-page story in the New York Times (11/13, A1, Liptak, Subscription Publication) asked, "If the federal government can require people to purchase health insurance, what else can it force them to do? More to the point, what can't the government compel citizens to do?" The piece noted that these "questions have been the toughest ones for the Obama administration's lawyers to answer in court appearances around the country over the past six months. And they are likely to emerge again if, as expected, the Supreme Court...agrees to be the final arbiter of the challenge to President Obama's signature health care initiative."
The Los Angeles Times (11/13, Savage, Levey) reported, "After a year and a half of legal skirmishing, President Obama's embattled healthcare law has arrived at the Supreme Court riding a surprising winning streak and carrying a constitutional stamp of approval from prominent conservative judges. Only three of the 12 appellate judges who have reviewed the law have decided it is unconstitutional to require all Americans to have health insurance," and "not a single appeals court judge has said the entire law must be tossed out, the position advocated by Florida and 25 other Republican states leading the legal assault." The Supreme Court "is expected to announce as soon as Monday" that it will hear the Florida case, "the largest and broadest challenge" to the law.
The Washington Post (11/13, Barnes) reported, "Today, there are unmistakable comparisons to the court's action on the Social Security Act of 1935 as the current justices consider whether to accept a constitutional challenge of the 2010 Affordable Care Act." The Post noted, "But there is an answer to the obvious question of why the health-care act might not be constitutional while Social Security -- and its offshoot Medicare -- are. They were built on separate constitutional powers."
NYTimes says Silberman opinion should bode well for healthcare law. The New York Times (11/11, Subscription Publication) editorialized, "A federal appeals court in the District of Columbia endorsed the constitutionality of healthcare reform this week in an opinion as notable for its authorship as for its legal reasoning. The majority opinion in the 2-to-1 decision was written by Judge Laurence Silberman, a stalwart of conservative jurisprudence whose views are said to be enormously influential in conservative legal circles. ... It is significant that prominent Republican judges have agreed with the Obama administration that a core element of the health reform law is constitutional. If the Supreme Court takes up the issue on appeal, it should affirm these judgments."
Reported by the American Association for Justice
Regulators warn small magnets can be hazardous to children
November 11, 2011
The Chicago Tribune (11/11, Gabler) reports the US Consumer Product Safety Commission "are warning parents that high-powered magnets marketed as desk toys and stress relievers for adults can pose a deadly hazard to kids." Kids "have been known to swallow the tiny magnets, which can then attract each other inside the body, causing small holes in the stomach and intestines, intestinal blockage, blood poisoning or other serious injuries that can be fatal."
The AP (11/11) reports the agency "has received 14 reports of problems with the magnets - up from seven reports last year and one in 2009." The children "ranged in age from 18 months to 15 years old. Eleven of the children required surgery to remove the magnets." CPSC Chairman Inez Tenenbaum said, "The symptoms can pose as a cold or the flu and send parents to the doctor multiple times before an X-ray is done revealing the blockage."
Reported by the American Association for Justice
FDA issues retailer warnings on cigarette sales to minors, other tobacco infractions
November 11, 2011
In continuing coverage, USA Today (11/11, Jackson) reports, "The Obama administration sent letters to 1,200 businesses today with an urgent warning: Don't sell cigarettes to kids. The letters from the Food and Drug Administration follow 'an aggressive inspection campaign and remind retailers of their legal responsibility to protect our children,' said White House spokesman Jay Carney.
The Hill (11/11, Pecquet) reports in its "Healthwatch" blog that Health and Human Services Secretary Kathleen Sebelius "touted the figures in a new blog post highlighting the administration's efforts to curb childhood smoking in the wake of a legal defeat this week." In the post, she "vowed that the administration would continue its efforts after a federal judge on Monday blocked graphic new cigarette warnings. District of Columbia Judge Richard Leon blocked the warning requirement from going into effect until a court rules on whether they violate the First Amendment."
CQ (11/11, Subscription Publication) adds that the Family Smoking Prevention and Tobacco Control Act of 2009 gives FDA the power to contract with states and territories to run compliance checks of tobacco retailers, and this year the agency "awarded contracts totaling more than $24 million to 38 states, for such inspections." It quoted FDA Commissioner Margaret Hamburg saying that, "It should worry every parent that 20 percent of U.S. high school students smoke cigarettes."
The AP (11/11, Felberbaum) interviews Dr. Lawrence Deyton, director of the FDA's Center for Tobacco Products, who says that retailers are "on the front line of helping to prevent our kids from initiating tobacco use. ... It's very important for every neighborhood to know that their retailers are enforcing this new law." The AP also notes that besides looking for illegal sales of tobacco to minors, inspectors check for other violations, such as selling single cigarettes, handing out samples or promotional materials like hats and T-shirts advertising tobacco, selling cigarettes that are flavored or come in packs marked with words like "light," "mild," or "low-tar." Retailers have 15 days to respond to the warnings letters, and face escalating fines and possible loss of the ability to sell tobacco for further violations.
Bloomberg News (11/11, Staiti) and Reuters (11/11, Selyukh, Wohl) also report the story.
Several local papers, including the Boston Globe (11/10, Kotz) and the Colorado Springs (CO) Gazette (11/10, Cotter), also report the local recipients of the FDA warning letters.
Reported by the American Association for Justice
Obama signs executive order on prescription drug availability
November 1, 2011
Fox News' Special Report (10/31, Baier) reported, "President Obama today continued his effort to appear as proactive as possible in the remedy for, as he says, an inactive Republican Congress. He addressed a problem we told you about earlier this month, the shortage of some prescription drugs." White House correspondent Ed Henry added, "President Obama still can't convince Congress to pass his jobs bill, so he brought a pharmacy manager and a cancer patient to the Oval Office to explain his move to deal with drug shortages that are putting lives at risk."
ABC World News (10/31, story 4, 0:30, Sawyer) reported that "for almost a year, we at 'World News' have been reporting on the growing drug shortages in this country. Chemotherapy drugs, antibiotics, heart medications, even those crash cart drugs used in emergencies. Well, today President Obama took action, signing an executive order, no Congressional approval necessary, to force drug companies to take action when there's a shortage on the horizon. The most immediate change, a crackdown on price gouging due to the shortages, and that will kick in, starting tomorrow." CBS (11/1) reports, "Health and Human Services Secretary Kathleen Sebelius and FDA Commissioner Peggy Hamburg were expected to join Obama at the White House as he signs the executive order."
In a story carried by more than 185 news sources, the AP (11/1) reports, "An Obama administration analysis concluded a big part of the problem is rising demand, especially for cancer drugs, that those companies haven't been able to boost production to meet. But, 'the main cause of drug shortages is economic,' argued Dr. Thomas J. Smith of Johns Hopkins' Sidney Kimmel Comprehensive Cancer Center and Virginia Commonwealth University pharmacist Mandy Gatesman in this week's New England Journal of Medicine."
The Hill (10/31, Pecquet) reports in its "Healthwatch" blog, "Efforts announced Monday 'will give us extra time to work with the industry to prevent, reduce or mitigate the shortage,' Health and Human Services Secretary Kathleen Sebelius told reporters on a conference call." She continued, "While we can't control all the factors that cause the shortages - starting with the fact that demand is outpacing supply - there are steps we can take. We can work with manufacturers to fix quality issues. We can work with other firms to increase production. And (the new order) will lead to earlier FDA notification of any impending shortages of certain prescription drugs."
Reported by the American Association for Justice
Studies Prove that Women Taking Yaz, Yasmin Have an Increased Blood Clot Risk of 75 Percent
October 28, 2011
The U.S. Food and Drug Administration (FDA) and the BMJ, f/n/a British Medical Journal, recently released studies, which prove that woman taking Yaz, Yasmin have a 75 percent greater chance of experiencing a serious blood clot.
Source: BMJ Study, New York Times, and NewsInferno
Study finds no link between cell phones, cancer
October 21, 2011
Major media sources provided coverage of a large study from Denmark that found no association between cell phone use and elevated cancer rates.
The AP (10/21) reports that the "Danish study of more than 350,000 people," the largest so far undertaken, "concluded there was no difference in cancer rates between people who had used a cellphone for about a decade and those who did not. ... Cancer rates in people who used cellphones for about 10 years were similar to rates in people without a cellphone. Cellphone users were also no more likely to get a tumor in the part of the brain closest to where phones are usually held against the head." However, groups including "MobileWise...said the study wasn't long enough to consider the long-term risk, since brain tumors can take decades to develop." The study was published in BMJ.
Bloomberg News (10/21, Gerlin) notes that "the research is the largest of its type and used data that was already available, instead of retrospectively interviewing phone subscribers whose recall could be selective or unreliable, the scientists said."
Reported by the American Association for Justice
Reports 15 Deaths Due To Growing Shortages Of Medications
October 14, 2011
FOX News (10/14, Roberts) reports on its website that "99.5 percent of hospitals have experienced a drug shortage in the past six months," and that "for many critical drugs, the cupboard is basically bare." In some cases, hospitals have turned to alternative suppliers, and paid anywhere "from 100-fold to 1,000-fold," for medications. So far, "the American Society of Health System Pharmacists reports at least 15 deaths that are directly attributable to the drug shortage." Some "Gray Market" Companies Selling At Substantial Markup. CBS Evening News (10/13, story 5, 3:35, Pelley) reported, "There is a critical shortage of life-saving drugs in this country. This week, five drugs were added to a list of more than 200 reported to be in short supply. Now it turns out some companies are hoarding these drugs to drive the price up." CBS (Keteyian) explained, "The record drug shortage has opened the door for so-called gray market companies that exploit the short supply." So "Congressman Elijah Cummings has launched an investigation into drug shortage profiteering." CBS (10/14) also offers a version of this story on its website.
Reported by the American Assocation for Justice
Half of children's car booster seats present risks
October 13, 2011
USA Today (10/13, O'Donnell) reports the Insurance Institute for Highway Safety (IIHS) found that "half of children's car booster seats aren't good enough to ensure a proper fit with safety belts" and recommended "parents avoid" six of them. The IIHS says "ti's impossible to tell which booster seats are better just by comparing prices, brands or features." Still, "the IIHS says booster seats have improved in the three years it has been testing them."
The Washington Post (10/13, Shaver) reports, "Of 83 booster seats evaluated, 41 fell into the 'check fit' category, meaning they might not provide adequate seat-belt fit for all children in all vehicles," 31 made the "best bets" category, properly positioning the seat belt in all vehicles. "Five boosters were ranked 'good bets' for providing a proper seat-belt fit in most vehicles."
This story is also covered by the AP (10/13), the website of ABC News (10/13, Stark), the "Wheels" blog of the New York Times (10/13, Jensen, Subscription Publication), and the "Driver's Seat" blog of the Wall Street Journal (10/13, Welsh, Subscription Publication).
Reported by the American Association for Justice
Vitamins associated with increased risk of death in older women
October 11, 2011
The CBS Evening News (10/10, story 8, 0:30, O'Donnell) reported, "More than half of American adults take dietary supplements."
ABC World News (10/10, lead story, 2:40, Sawyer) added, "A major new study in an important medical journal finds in some cases the supplements either do no good or could increase the risk of dying from cancer or heart disease."
NBC Nightly News (10/10, lead story, 2:40, Williams) reported that the study published in the Archives of Internal medicine found that "women who take supplements, including multivitamins, appear to have slightly higher death rates." NBC chief science correspondent Robert Bazell explained, "Researchers followed more than 38,000 women average age 61 for 19 years. They found higher death rates in those taking multivitamins, vitamin B-6, folic acid, zinc, magnesium, copper and iron."
Reported by the American Association for Justice
Taskforce warns against blood test for prostate cancer
October 10, 2011
ABC World News (10/7, lead story, 2:15, Sawyer) reported, "An earthquake today in the debate over men and prostate cancer" regarding a "simple blood test called a PSA. Twenty million men use it to find out if they show a sign of risk, yet today, a government task force is saying healthy men should skip that test, arguing that the treatment that often follows the test may not be worth the consequences."
Healthcare field reacts to PSA downgrading. On its front page, the New York Times (10/8, A1, Harris, Subscription Publication) continues coverage of the news that the US Preventive Services Task Force (USPSTF) "found that a PSA blood test to screen for prostate cancer does not save lives, but results in needless medical procedures that have left tens of thousands of men impotent, incontinent or both." However, "urologists -- the doctors who most often treat prostate cancer -- promised to fight. The American Urological Association issued a statement saying that the recommendation 'will ultimately do more harm than good.'"
Reported by the American Association for Justice
Death toll in cantaloupe-linked listeria outbreak hits 18, 100 illnesses confirmed
October 6, 2011
The AP (10/5, Jalonick) reported that federal health officials "have raised the death toll to 18 in an outbreak of listeria in cantaloupe. The Centers for Disease Control and Prevention said Tuesday it has confirmed 100 illnesses in 20 states, including the 18 deaths. The agency said it has confirmed two additional deaths in Colorado and one in Kansas since last week." The death toll is almost certain to rise, as listeria-linked outbreaks can have incubation periods approaching two months.
The Los Angeles Times (10/5) noted that it is "the nation's deadliest food-borne outbreak in more than a decade," and the Jensen Farms in Colorado "recalled its cantaloupes on Sept. 14 after the melons were found to have been contaminated by four strains of Listeria monocytogenes bacteria." MSNBC (10/5, Aleccia) added that in the outbreak, "most of those who became ill are older than 60, with an average age of 79. Of 93 people for whom information is available, 91 were hospitalized."
Bloomberg News (10/5, Flinn) noted that the Centers for Disease Control and Prevention in its most recent update assures consumers that cantaloupes known not to have originated at the Jensen Farm in Colorado "are safe to eat."
USA Today (10/5, Weise) reported that FDA Commissioner Margaret Hamburg "said Tuesday that her agency is investigating the cause of the outbreak. The FDA and CDC have had teams in Jensen Farms fields and packing sheds, testing the soil, water and surfaces for clues. Listeria bacteria grow in moist, muddy conditions and are often carried by animals."
The Washington Times (10/5, Richardson) reported that for the residents of Rocky Ford, Colorado, the outbreak at Jensen Farms, nearly 100 miles to the east, "delivered a body blow to Rocky Ford's reputation for top-notch melon and its small but scrappy farming culture."
Produce distributor, grower sued over cantaloupe outbreak. The Houston Chronicle (10/5, Pack) reported that South Texas produce grower and distributor Frontera Produce has been named in at least three lawsuits over a listeria outbreak tied to contaminated cantaloupes. One lawsuit was filed Monday in a Texas state court by an Oklahoma burse who was hospitalized for over two weeks with a listeria infection. Two other suits were filed by a Seattle law firm, one in Oklahoma and another in a federal court in Maryland, by relatives of persons after falling victim to listeriosis. Also named in the lawsuits was grower Jensen Farms of Colorado.
Reported by the American Association for Justice
Blue Shield removes coverage for breast cancer drug
October 4, 2011
The New York Times (10/3, Pollack, Subscription Publication) reported, "Blue Shield of California will no longer pay for the use of the drug Avastin to treat breast cancer, a sign that support for the widely debated and expensive treatment may be eroding among health plans." The Times notes, "Blue Shield, with 3.2 million members, is apparently the first large insurance company to end payments since a federal advisory committee unanimously recommended in June that the Food and Drug Administration rescind Avastin's approval as a treatment for breast cancer, saying the drug did not really help patients. Shortly after the F.D.A. advisory committee's negative vote, a panel of breast cancer doctors convened by the National Comprehensive Cancer Network, an organization of major cancer hospitals, reaffirmed that Avastin was 'an appropriate therapeutic option for metastatic breast cancer'...important because Medicare and UnitedHealthcare are supposed to pay for drugs listed in the cancer network's guidelines."
Reported by the American Association for Justice
Tyson recalls ground beef over E. coli threat
September 30, 2011
The AP (9/29) reported that Tyson Fresh Meats Inc. "is recalling about 131,300 pounds of ground beef because a family in Ohio fell ill after eating meat produced by the company that was contaminated with E. coli, the US Department of Agriculture reported Wednesday." The meat was produced at a plant in Emporia, Kansas, and a sample of ground beef taken from the family's home tested positive for the bacteria. No other illnesses were reported in connection with the voluntary recall by Tyson.
Noting E. coli incident in speaker's district, House Democrat blasts GOP stance on food-safety budget. The Hill (9/29, Lillis) reported in its "Healthwatch" blog that a leading Democrat "is blasting Republicans for scaling back food-safety precautions after four children living in the district of House Speaker John Boehner (R-Ohio) were sickened by contaminated beef." Rep. Rosa DeLauro (D-Conn.), ranking member of a House appropriations subcommittee, "said the episode 'should serve as a wake-up call' for Boehner and other GOP leaders that Congress must take greater steps to prevent foodborne illness."
Reported by the American Association for Justice
FDA cracks down on false LASIK claims
September 30, 2011
HealthDay (9/30, Mann) reports, "The US Food and Drug Administration is once again cracking down on eye care professionals who make false safety claims and promises about the popular LASIK eye surgery." In its Letter to Eye Care Professionals, which it issued this week, the FDA "is now giving eye doctors 90 days to get in line and update any advertising or promotional materials that make false claims. After this time, the agency will take regulatory action, said FDA spokeswoman Erica Jefferson."
Reported by the American Association for Justice
Common NSAIDs may increase heart risk
September 30, 2011
The UK's Telegraph (9/28, Collins) reported, "Taking daily doses of over-the-counter painkillers can increase the risk of heart attacks and stroke," according to "a new paper compiling evidence from 51 international studies into the impact of a range of NSAIDs on more than 2.7 million patients."
HeartWire (9/28, O'Riordan) reported that the research "confirms that rofecoxib (Vioxx, Merck) is associated with a significantly increased risk of cardiovascular events, while also suggesting that diclofenac, a widely used, over-the-counter NSAID, also poses an equivalent risk to patients." The investigators found that "of the medications studied, ibuprofen and naproxen are the least likely to increase the risk of MI and coronary heart disease death." The investigators "also observed a significantly increased risk of cardiovascular events in patients treated with indomethacin, an older NSAID historically used to treat gout." The research is published in PLoS Medicine.
Reported by the American Association for JusticeCDC, FDA predict cantaloupe illnesses, deaths will rise
September 29, 2011
The AP (9/29, Jalonick) reports Centers for Disease Control and Prevention and FDA heads on Wednesday predicted "more illnesses and possibly more deaths may be linked to an outbreak of listeria in cantaloupe in coming weeks." Infected cantaloupes produced by Jensen Farms in Colorado and shipped to 25 states have thus far caused "at least 72 illnesses, including up to 16 deaths, in 18 states." Sickness and death tolls are expected to rise in coming weeks, CDC director Thomas R. Frieden and FDA Commissioner Margaret A. Hamburg said, because listeria's incubation can be a month or more. "We will see more cases likely through October," the FDA Commissioner stated. While cantaloupe is often the source in other outbreaks, this is its first known involvement in a listeria outbreak, which Hamburg termed a "surprise." The FDA's Office of Foods is investigating the farm's water supply, possible animal intrusions or other causes to determine how the cantaloupes became contaminated.
MedPage Today (9/29, Neale) notes that the CDC reports that most persons who came down with listeriosis are over age 60 or have conditions weakening their immune system. It adds that the FDA's investigation includes "collaborating with state health officials to check retail stores, wholesalers, and distributors to make sure they know about the recall and that they have taken steps to inform customers and remove affected product from shelves."
CNN (9/29) reports that Dr. Hamburg on the conference call noted that Jensen Farms cantaloupe harvest has ended for the year. The account also noted that a food safety lawyer had filed four lawsuits against Jensen Farms and Frontera Produce.
The Los Angeles Times in its "Booster Shots" blog (9/29, Khan) adds that listeria outbreaks are "particularly dangerous for pregnant mothers, older adults and those with compromised immune systems." It notes that some states, like New Jersey, have not yet reported any occurrences, although they reportedly received shipments of tainted cantaloupes.
The Washington Post's "All We Can Eat" blog (9/29, Carman) reports that Jensen Farms was not known to have shipped any of the recalled cantaloupes to Maryland, although some were shipped to Virginia, and Maryland health officials say that where Maryland's single fatality to date ate the infected fruit "remains a complete mystery."
CDC director Frieden appeared on a segment of the PBS News Hour (9/28, Ifill). The CDC chief noted there that there have already been 12 multistate outbreaks of foodborne illnesses this year, which he said was "partly a reflection of the increasing complexity of our food supply. It's also because we're doing a better job. We're tracking the genetic pattern of an increasing proportion of the foodborne illnesses that occur."
Reported by the American Association for JusticeSurvey finds health insurance costing more, covering less
September 28, 2011
Major national news outlets including network news gave substantial coverage to a Kaiser Family Foundation report on health insurance coverage and costs. The reports emphasized the higher rates and reduced coverage with one outlet noting that family insurance now costs more on average than a small car. Many also noted the report's conclusion that the Affordable care act was responsible for a small amount (2 percent) of the increase in rates.
Reported by the American Association for JusticeFDA concerned by higher risk of blood clots in women using drospirenone
September 27, 2011
The Newark (NJ) Star- Ledger (9/27, Todd) reports, "The Food and Drug Administration said preliminary results of an agency-funded study show women using Yaz and other birth control pills with the synthetic hormone drospirenone face ... a 1 1?2 times greater risk of experiencing" blood clots "compared with women using other, older birth control pills," according to study of "800,000 women in the US." The FDA announced that it "has not yet reached a conclusion, but remains concerned, about the potential increased risk of blood clots for women who use drospirenone-containing birth control pills."
The Wall Street Journal (9/27, Dooren, Subscription Publication) notes that all birth control pills come with an increased risk of blood clotting and says that the FDA found differing risks identified by different studies. Bayer, which sells drospirenone, says the risk is similar to that of other oral contraceptives.
Reported by the American Association for JusticePrimatene mist inhalers to go off market after December 31
September 23, 2011
Dow Jones Newswire (9/23, Rubin, Subscription Publication) reports that the US Food and Drug Administration says that Primatene Mist epinephrine inhalers, which are the only over-the-counter inhalers approved by the FDA, will not be produced or sold after December 31, because they use chlorofluorocarbons as propellant.
The AP (9/23) reports, "The FDA finalized plans to phase out the products in 2008 and currently only Armstrong Pharmaceutical's Primatene mist is still available in the US."
The CNN (9/23, Young) "Chart" blog reports that "asthma patients can continue using an inhaler that's not empty by the December 31 deadline as long as the expiration date is still good." While many asthma inhaler "manufacturers have already replaced their CFC inhalers with a propellant called hydrofluoroalkane or HFA, which is more environment-friendly...there's currently no HFA version of an epinephrine inhaler available."
Reported by the American Association for JusticeJudge rules Teva bound to cover liability over tainted propofol
September 21, 2011
Bloomberg News (9/21, Feeley) reports, "Baxter International Inc. won a bid to force Teva Pharmaceutical Industries Ltd. (TEVA) to pay costs of defending Nevada lawsuits alleging that the drugmakers' sales of the anesthetic propofol led to patients developing hepatitis." Delaware Chancery Court Judge Travis Laster ruled that the conclusion of an arbitration panel that "found that Teva was bound by an agreement to cover all liability tied to claims that tainted vials of propofol caused colonoscopy patients to develop hepatitis," was "valid and enforceable." Under that ruling, "Teva faces almost 300 lawsuits stemming from a hepatitis C outbreak three years ago in southern Nevada," in which "Nevada health officials blamed the reuse of propofol vials for infecting patients with the incurable liver disease." The case is Baxter International Inc. (BAX) v. Teva Pharmaceuticals USA Inc., 6819, Delaware Chancery Court (Wilmington.)
Reported by the American Association for Justice
HHS grants to help states conduct insurance rate reviews
September 21, 2011
Several news outlets noted the announcement that HHS is providing grants to help states conduct insurance rate reviews. The coverage was positive for the most part, although some sources pointed out the insurance industry's objections. The Los Angeles Times (9/21, Levey) reports, "The Obama administration Tuesday announced $109 million in grants to states to help them beef up oversight of health insurers, a key goal of the healthcare law the president signed last year." These "grants come on the heels of new rules that require insurers to post on their websites explanations of premium increases exceeding 10% and to justify the hikes to state and federal regulators, who also will post them starting this year." Steve Larsen, "who oversees the insurance efforts at" HHS, said, "We absolutely expect for this...to help have a moderating influence on premiums."
Reported by the American Association for Justice
Study says physician fees major factor in higher overall US healthcare costs
September 9, 2011
The New York Times (9/8, A19, Pear, Subscription Publication) reports, "Doctors are paid higher fees in the United States than in several other countries, and this is a major factor in the nation's higher overall cost of health care," according to a study published Sept. 8 in the journal Health Affairs. The study "found that the incomes of primary care doctors and orthopedic surgeons were substantially higher in the United States than in other countries." What's more, "the difference results mainly from higher fees, not from higher costs of the doctors' medical practice, a larger number or volume of services or higher medical school tuition."
For example, "Medicare and private insurers pay US physicians more for their services than public and private insurers pay for the same services in other countries; in some cases American doctors are paid double for the same services," MedPage Today (9/8, Walker) reports. Overall, "the US spends $7,538 per person on healthcare, or 16% of the nation's total gross domestic product (GDP)," and "spending on ambulatory care in physician offices accounts for 21.2% of the overall tab," the study found.
Reported by the American Association for Justice
Brain stent treatment may double risk of repeat stroke
September 8, 2011
The CBS Evening News (9/7, story 7, 0:25, Pelley) reported, "There was disappointing news today about the use of brain stents." A study published online Sept. 8 in the New England Journal of Medicine "found when the stents were used on patients who already had a stroke, they can more than double a risk of another stroke or even death when compared with...therapy or lifestyle changes."
On its front page, the New York Times (9/8, A1, Kolata, Subscription Publication) explains that in 2005, "the Food and Drug Administration approved the device...on the basis of a humanitarian exemption, which did not require solid evidence that it would prevent strokes." Now, "the finding that the devices actually more than doubled the rate of stroke or death raised serious questions about whether the FDA's procedures for approving such a medical device ended up putting patients at risk." Meanwhile, "Larry Kessler, an expert on medical devices and a former director in the FDA's Center for Devices and Radiological Health, said that the humanitarian exemption made sense sometimes, but that the new study showed its dangers."
Reported by the American Association for Justice
Johnson & Johnson faces suits over Levaquin and tendon ruptures
September 7, 2011
Bloomberg News (9/7, Feeley) reports that in a case in Atlantic City, New Jersey, Johnson & Johnson is being tried for having "failed to properly warn two New Jersey men that the antibiotic Levaquin could damage their tendons," and of having "downplayed Levaquin's risks in warning labels." J&J attorney Christy Jones said that the company "repeatedly warned doctors and patients about reports linking tendon ruptures to Levaquin, starting when it was approved for sale in the US in 1996." The story notes that "in 2008, the US Food and Drug Administration required all makers of antibiotics in Levaquin's class to beef up warnings about tendon ruptures." The company "faces more than 2,600 claims in US courts over the drug, court dockets show." The case is Beare v. Johnson & Johnson, L-196-10-MT, Superior Court of New Jersey for Atlantic County (Atlantic City).
Reported by the American Association for Justice
Automated defibrillators often fail, researchers say
September 6, 2011
MedPage Today (9/2, Walsh) reports that a research paper appearing online in the Annals of Emergency Medicine finds that the FDA "has received more than 1,000 reports over 15 years of deaths following failure of automated external defibrillators, a retrospective analysis showed. In 37 of the events, the defibrillator failed to even power on, and in 22% of the cases the device was unable to complete the heart rhythm analysis, according to Lawrence A. DeLuca Jr., MD, of the University of Arizona in Tucson, and colleagues." The most common failure, accounting for 45%, was when the defibrillator failed to deliver a shock recommended after rhythm analysis. Since in those cases a backup device was often successful when the primary defibrillator failed, the researchers recommended that public access programs provide backup units when possible.
Reported by the American Association for Justice
Sebelius: rules to protect consumers from rate hikes become effective
September 2, 2011
HHS Secretary Kathleen Sebelius writes in a Huffington Post (9/1) piece that a provision in the Affordable Care Act which will protect consumers against insurance industry abuses goes into effect today. She says that because of the provision, "insurers must submit a written justification every time they try to raise your premium by ten percent or more. As rate increases are proposed, that information will be posted in a clear, easy-to-understand format on the new consumer website Healthcare.gov." In addition, "rates will...be evaluated by experts to see whether they're justified, and that information will be made available to consumers too." Sebelius argues that because of the ACA, "the deck is no longer stacked in insurers' favor," and henceforth, insurers who attempt to increase premiums "by double digits" must "explain themselves."
Nevada Insurance Division taking comments on rate increases. The Las Vegas Sun (9/1, Ryan) reports, "The state Insurance Division will begun accepting consumer complaints about increases to company health insurance costs this week." The division must approve rate increases "for individuals and small employer groups," and now, under the Affordable Care Act stares must "give consumers a chance to express their feelings about these proposed premium hikes." To do that, "the state Insurance Division has installed a new section on its website" starting today, where people may register comments.
Reported by the American Association for Justice
FDA recommends surgical mesh be reclassified as "high risk"
September 2, 2011
Bloomberg News (9/1, Edney) reports, "A Food and Drug Administration staff recommendation" says that transvaginally implanted surgical mesh "products fail to lead to better outcomes than non-mesh repair and should be reclassified as posing a high risk to patients," and the mesh makers "may have to submit added safety data to regulators to keep their products on the market." Bloomberg News adds that a "change in risk classification may take several years to complete and the agency said it could consider a grace period for makers of products on the market to submit data to comply with a more stringent review."
Reported by the American Association for Justice
Cardiac implants, related infections on the rise
August 30, 2011
The New York Times (8/30, Bakalar, Subscription Publication) reports in "Vital Signs" that "the number of implantable cardiac devices in use has doubled since 1993, and the number of infections associated with them has more than tripled," according to a study published in The Journal of the American College of Cardiology. Investigators found that "the incidence of infection in 2008 increased to 2.4 percent from less than 1.5 percent in 2004." While "the reasons for the increase are not clear...the recipients' age and poorer health may be factors."
Reported by the American Association for Justice
PolitiFact calls Perry's tort reform claims "false"
August 29, 2011
The Hill (8/27, Baker) "Healthwatch" blog reported, "The website PolitiFact.com on Friday threw some cold water on Texas Gov. Rick Perry's (R) claims about tort reform in his state -- claims tort-reform supporters often tout as a model for other states." While campaigning, the governor has said that "Texas gained 21,000 new doctors because of malpractice reforms in his state." However, PolitiFact "found that in the years since Texas's tort reform law passed, the number of doctors in the state has risen only slightly more than the overall population." Therefore, the site called the claim "false."
Marilyn Werber Serafini also cited the PolitiFact analysis in NPR's (8/26) "Health" blog, noting that "Texas has only about 13,000 more doctors in the state and the historic trends suggest that population growth was the driving factor." PolitiFact's Jon Greenberg also noted other aspects of "PerryCare," including that "'Rick Perry believes the best way for the federal government to improve health care is to stimulate job creation so more Americans are covered by employer-sponsored health plans,' according to his campaign website."
Additionally, the Daily Kos (8/28, Jcullen) highlighted a number of reports debunking Perry's tort reform claims. A July article from the Austin American-Statesman reported that "almost half of the state's job growth in the past two years came in the education, health care and government sectors." More recently, an August Washington Post article noted Perry's job growth claims but said "he is less forthcoming about the 26% of Texas residents who lack health insurance - ranking 50th among the states - compared with a national average of 17%." And a Public Citizen report said Perry's 2003 tort reforms haven't tamed health costs but "Texas Medicare reimbursements have actually been rising faster than the rest of the country."
Apology laws working to reduce medical malpractice suits, study says. Christopher Shea reported in the Wall Street Journal (8/26) "Review Ideas Market" blog on a study concluding that apology laws work to cut medical malpractice suits. Researchers Elaine Liu and Benjamin Ho inspected 225,000 malpractice payments between 1991 and 2009 among states with and without apology laws. States with apology laws settled the most serious malpractice cases approximately 20 percent faster and payments decreased by $55,000 to $73,000. Liu and Ho found similar trends among slightly serious cases. The study is to be published in an upcoming issue of Journal of Risk and Uncertainty, Shea noted.
Reported by the American Association for Justice
Medtronic accused of ignoring insulin pump security concerns
August 26, 2011
The AP (8/26, Robertson) reports that Jay Radcliffe, a user of a Medtronic Inc. insulin pump, had discovered through his own efforts "serious security holes" that would allow someone "to program a special remote control to command strangers' pumps to dispense the wrong dosage of insulin." When he attempted "to alert the company to the defects," he said that he was ignored. He then "revealed the details to The Associated Press ahead of a planned news conference." Radcliffe also contacted "the Department of Homeland Security, which examined his research, [and] helped make the introduction to Medtronic, [but] his calls and e-mails went unanswered." Despite this, Radliffe "said Medtronic customers should continue to use their pumps, as the techniques he developed are hard to execute in the real world." Meanwhile, Reps. Anna Eshoo (D-CA) Edward Markey (D-MA) "have asked the Government Accountability Office...to evaluate the government's efforts to identify the risks of implants and other medical devices that use wireless communication."
The Minneapolis Star Tribune (8/26, Moore) adds that "Radcliffe and others suspect the security vulnerabilities could extend to other devices, such as pacemakers and implantable heart defibrillators." Medtronic CEO Omar Ishrak said that "Security systems on new pumps will improve going forward," adding that "there's never been an incidence of pump hacking in the real world."
Reuters (8/26, Finkle) reports that "John Mastrototaro, a physician who serves as vice president of research and development for Medtronic's diabetes division," said, "The likelihood of this accidentally happening is nil." Radcliffe "called on the public to pressure Medtronic to take action to make the devices safer, even though he said that the risk to any individual patient was extremely low." Mastrototaro "said it would be difficult to make changes to pumps already in use because of US FDA regulations that require device makers to get agency approval before changing anything in their products, including issuing software patches."
Reported by the American Association for Justice
New passenger protection rules take effect
August 25, 2011
Coverage of new passenger protection rules was widespread, particularly among local TV outlets, and mostly positive in tone, with the majority of reports noting the rules seek to provide a "less stressful" travel experience for the consumer.
For example, the Raleigh News & Observer (8/24, Martin) said US DOT rules took effect Tuesday making passengers bumped from domestic flights eligible to receive up to $1,300 and requiring air carries to refund checked-baggage fees for lost luggage. Under the new rules, compensation for bumped flights increased from the previous maximum of $800, and last year's tarmac rules now apply to international flights. The rules "are the latest to be imposed by federal regulators over the last two years in response to several notorious cases of flight delays."
Under the headline, "New Rules Aim For More Passenger-Friendly Skies," NPR (8/24) said the new rules were designed to make flying more convenient, so all airline passengers "should like some new government regulations that took effect Tuesday." According to Secretary LaHood, the new passenger protections "will 'help ensure that air travelers receive the respect they deserve before, during and after their flight.'" FlyersRights.org President Kate Hanni praised the new rules and credited US DOT, saying: "It's the first time in history this DOT has taken on airline passenger issues, and [it] really is doing a very good job."
In its lede, Market Watch (8/24) said, "Fliers, the US has your back with new rules starting Tuesday." The report quotes Transportation Secretary Ray LaHood as saying, "The Obama administration believes consumers have the right to be treated fairly when they fly."
A San Francisco Chronicle (8/24, Parker) blog cited research by independent airline consultants Darryl Jenkins and Joshua Marks that found tarmac rules have caused more flight cancellations, a finding disputed by Secretary LaHood, who said in his blog: "'The number of flights canceled after tarmac delays of more than two hours -- the flights that could have conceivably been canceled to avoid violating the rule -- increased only slightly' since the rule took effect. But Jenkins says that's because airlines worried about penalties are not waiting two hours to cancel flights, they are canceling a lot more flights after 90 minutes to make sure they have time to get back to the gate and remove other planes if necessary, which leads to more flight cancellations throughout the system."
USA Today (8/24, Yu) noted in its Travel Section that the new DOT rules require air carriers to "prominently disclose all ancillary fees on their websites, including fees for checking bags."
On its website, CNN (8/24, Pawlowski) said the Association of Passenger Rights "applauded the rules, calling them long overdue. 'If you talk to most air travelers...traveling on the airlines is about as popular as the US Congress right now,' said Brandon Macsata, a spokesman for the group."
Reported by the American Association for Justice
FDA sees surge in complaints about all-metal hips
August 24, 2011
The New York Times (8/23, A1, Meier, Roberts, Subscription Publication) reports on its front page, "The federal government has received a surge in complaints in recent months about failed hip replacements," totaling "more than 5,000 reports since January about....metal-on-metal hips." The complaints are chiefly that an all-metal hip has had to be replaced "after only a few years," and "some patients have suffered crippling injuries caused by tiny particles of cobalt and chromium that the metal devices shed as they wear." As a result, "the FDA in May ordered producers to study how frequently the devices were failing and to examine the threat to patients." Now metal hips have "plummeted to about 5 percent of the market." One problem identified by the FDA's Dr. William Maisel is, "There is not an existing infrastructure for studying this kind of information."
Reported by the American Association for Justice
Study says many physicians face malpractice claims but few pay
August 18, 2011
The AP (8/18, Stobbe) reports that "Only 1 in 5 malpractice claims against doctors leads to a settlement or other payout," according to a new study published in the New England Journal of Medicine. The results "might seem to support a common opinion among doctors that most malpractice lawsuits are baseless, but the authors said the truth is more complicated than that." In fact, the researchers said, "given the expense and other difficulties involved in winning, it's doubtful most claims are filed on a greedy whim." The AP article details some of the specific findings of the study. Among these findings were that "fewer than 2 percent of doctors each year were the subject of a successful claim, in which the insurer had to pay a settlement or court judgment."
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Mylan pushes deal between FDA, generic drugmakers
August 17, 2011
The Pittsburgh Tribune-Review (8/17, Nixon) reports that the tentative agreement between generic drugmakers and the FDA to provide $299 million in funding annually to speed approval of generic drugs and pay for inspection of foreign plants "was pushed by Mylan Inc. to ensure the safety of generic drugs made overseas for the US market and to eliminate an incentive to ship American jobs to foreign countries." Heather Bresch, president of the Canonsburg, Pennsylvania producer, "said it costs 25 percent more to manufacture generics in the United States than overseas because foreign plants don't have to meet the same quality standards. 'I'm not asking to have an incentive to be in the US,' she said. 'But there should be parity and a level playing field.'" FDA spokeswoman Sandy Walsh "said the agency hopes to be able to take a proposal for a package of new fees, including $299 million from generic drugmakers, to Congress by January."
Reported by the American Association for Justice
Indiana State Fair Stage Collapse
August 16, 2011
Stage wreckage examined for clues...With five dead, quesitons are arising about whether the Indiana Fair should have scrubbled country music Sugarland show as high winds approached.
Source: The Wall Street Journal
GOP lawmakers may cut health reform funding to reduce deficit
August 15, 2011
CQ (8/12, Reichard, Subscription Publication) reports, "The federal debt limit agreement gives opponents of the health care law as many as three chances to strike at its funding," yet, it is possible "that they will be able to deal only glancing blows." These "opportunities come in the form of $900 billion in cuts through the agreement's caps on discretionary spending; the provision for $1.2 trillion or more in additional deficit reduction to be negotiated by the Joint Select Committee on Deficit Reduction and enacted by the end of this year; and in the automatic cuts that will kick in if the committee can't agree on all $1.2 trillion in deficit reduction." CQ says that "the debt agreement...creates a powerful dynamic for Republican critics of the health care law to divert its half a trillion dollars in Medicare and Medicaid cuts to deficit reduction and away from coverage of the uninsured."
Groups prepare to lobby supercommittee on funding cuts. Reuters (8/12) reports that, as likely targets for cuts in lawmakers' efforts to reduce the deficit, the defense and healthcare industries are devising strategies to convince members of the supercommittee to minimize the impact of any reductions. Reuters says that each group is employing a different tactic. For the health industry, this is a familiar battle, since it has often been the target of proposed cuts in the past. In contrast, this is very unfamiliar territory for the defense industry.
Reported by the American Assocaition for Justice
Medication patches pose oft -overlooked danger to children's safety
August 15, 2011
MSNBC (8/12, Aleccia) reports that patient-safety experts are warning "parents, grandparents and other caregivers about potential hazards" to children posed by "transdermal medications. Some children have found the patches in home trash cans, or had them adhere to their skin after they rubbed off during close contact -- even a grandparent's hug -- leaving youngsters vulnerable to inadvertent overdoses of drugs ranging from painkillers and nitroglycerin to nicotine." Although thus far, "no complete data are available for child poisonings" related to medicated patches, government records indicate "at least four children have died and six have been hospitalized since 1997 after being exposed to just one type of transdermal drug, the fentanyl patch." Another three youth were "exposed to the drug, but the outcome wasn't recorded," according to the FDA's adverse-events data.
Reported by the American Association for Justice
J&J to settle criminal charge related to risperidone marketing
August 10, 2011
The New York Times /Bloomberg News (8/10, B8, Subscription Publication) reports, Johnson & Johnson has "reached an agreement in principle to settle a misdemeanor criminal charge related to the marketing of its antipsychotic drug Risperdal [risperidone]," according to its quarterly filing. Since 2004, federal prosecutors have been investigating the antipsychotic on allegations that it was being marketed "for unapproved uses," the pharmaceutical company said. The agreement in "principle on the criminal charge is on a single misdemeanor violation of the Food, Drug and Cosmetic Act" and "the Justice Department and the US Attorney in Philadelphia 'are continuing to pursue both criminal and civil actions,'" J&J said, adding that it had "adjusted the accrued amount in the second quarter of 2011 to cover the financial component of the proposed criminal settlement, but did not disclose an amount for the reserve."
Reported by the American Association for Justice
Excessive lab tests may leave some heart attack patients anemic
August 9, 2011
Bloomberg News (8/9, Renick) reports that "patients who enter hospitals due to heart attacks may be leaving with anemia caused by laboratory tests that draw too much blood, raising their risk of declining health and death," according to a study published in the Archives of Internal Medicine.
The Wall Street Journal (8/8, Hobson) "Health Blog" reported that for the study, investigators used data from more than 17,600 heart attack patients who were treated at 57 different hospitals.
McClatchy (8/9, Bavley) reports that the researchers found that while "none of these patients had anemia - depleted levels of red blood cells that carry oxygen - when they entered the hospital...one in five developed moderate to severe anemia during their hospital stay. The more blood they had drawn, the greater was their risk." The investigators found that "on average, the patients with hospital-acquired anemia had a total of 6 ounces of blood drawn, twice as much as the patients who didn't become anemic."
Reported by the American Association for Justice
DOJ subpoenas Merck over marketing of three drugs
August 9, 2011
The AP (8/9) reports that drugmaker Merck "says it has received a subpoena from federal prosecutors investigating the company's marketing of three drugs acquired through its 2009 acquisition of Schering Plough." Merck "disclosed the request for information from the Department of Justice in a regulatory filing Monday morning. The government is investigating marketing and selling of the brain cancer drug Temodar [temozolomide] and hepatitis C drugs PegIntron [peginterferon alfa-2b] and Intron A [Interferon alfa-2b, Recombinant for Injection]."
The Wall Street Journal (8/9, Loftus, Subscription Publication) reports that a Merck spokesman said the firm is cooperating with the probe.
Reported by the American Assocaiton for Justice
Study says single-payer healthcare system would save US $27.6 billion annually
August 5, 2011
The National Journal (8/4, Fung, Subscription Publication) reported, "Researchers at the University of Toronto said the United States could save about $27.6 billion each year if it followed in Canada's footsteps by implementing a single-payer health care system, which would cut down on the amount of time and money doctors spend on dealing with multiple insurance companies," according to a study published online Aug. 3 in the journal Health Affairs. The study found that "doctors spend about $22,000 per physician per year in Ontario," whereas "doctors in the United States spend almost four times as much -- $83,000 -- because they must deal with a range of insurance plans, frequently employing an administrator dedicated to sorting out the paperwork."
The Orlando Sentinel (8/5, Doughman) reports that American physicians "must spend time obtaining authorization for certain medical procedures, which, the authors said, can ultimately save money and prevent doctors from giving inappropriate care." The study authors also "concluded that American physicians and insurance companies could interact 'much more efficiently' if claims were filed electronically rather than via mail or fax."
What's more, "medical practices in the US spend nearly four times as many hours a week dealing with insurers than do practices in Canada, at nearly four times the cost," MedPage Today (8/4, Walker) reported. "US doctors spend only about one hour more each week interacting personally with health plans than their neighbors to the north (3.4 hours versus 2.5), but practice staffers in the US spend nearly 10 times more hours dealing with insurance companies than do the staff of Canadian practices," the study found.
Medscape (8/4, Crane) reported that the study authors cited "recommendations from the Institute of Medicine and others that include 'creating common, possibly mandatory standards for billing, claims payment, prior authorization, etc.; making all standard interactions electronic; using a single credentialing process; using a single quality measurement process; and using automated verification at the point of care of patient eligibility for health insurance benefits.'" In addition, they noted that "Section 1104 of the Affordable Care Act of 2010 instructs the Secretary of Health and Human Services to take steps to simplify interactions between providers and health plans." Finally, "the reform law's emphasis on new payment methods, such as bundled payments and pay-for-performance, and new ways of organizing healthcare delivery, such as accountable care organizations, could move US health care away from fee-for-service payment," thereby reducing administrative costs.
Reported by the American Association for JusticeFord recalls 1.1 million pickup trucks with potentially-explosive gas tanks
August 2, 2011
The AP (8/1) reported over one million Ford pickup trucks are involved in a recall over concerns that metal straps securing the trucks' gas tanks "can rust, allowing them to fall, rupture and catch fire," the National Highway Traffic Safety Administration said Monday on its website. The recall includes some Ford F-150s between model years 1997 and 2004 and F-250s between model years 1997 and 1999. Also "affected are Lincoln Blackwood pickups from the 2002 and 2003 model years." Ford spokesman Wes Sherwood "said the company will notify owners in September to bring their trucks to dealers who will replace the straps with new ones that are coated to resist corrosion." The Chicago Tribune /Cars.com (8/1, Thomas) reported the 1.1 million vehicle recall is "because in certain cold-weather states, road chemicals can corrode the fuel tank straps." It adds, "The recall will begin on or around Sept. 12 in Connecticut, Delaware, Illinois, Indiana, Iowa, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Vermont, West Virginia, Wisconsin and Washington, D.C." These states utilize large amounts of salt and other chemicals on their roads during the winter, the Wall Street Journal (8/1, Welsh) reported in its "Drivers' Seat" blog. The NHTSA initiated an investigation into the gas tank issue a year ago. AFP (8/1) reported, the NHTSA's recall announcement said "prolonged exposure to road deicing chemicals may cause severe corrosion of the fuel tank straps which secure the tank to the vehicle." Additionally, about "120,000 trucks in Canada would be affected by the recall, Ford said." MarketWatch (8/1, Langlois) reported nearly 97 percent of complaints have come from trucks sold or driven in highly-corrosive parts of the country. Reuters (8/1, Klayman) reported identifying high-corrosive areas as a potential problem narrowed the recall from 2.7 million to 1.2 million. Before Ford installs permanent fixes, dealers can put in a cable to support the existing strap, the NHTSA said. It added that putting in a steel strap can serve as a permanent repair. Ford has reported three fires and an injury related to the defect.
Reported by the American Association for Justice
FDA issues warning alert about counterfeit "morning-after" pill
August 2, 2011
Medscape (7/29, Hitt) reported that the Food and Drug Administration on Friday warned against the use of a "'morning-after' pill called Evital, especially in some Hispanic communities." The drug "has not been approved for use" in the US; and according to the warning released by the Center for Drug Evaluation and Research's Division of Drug Information, the "packaging label of the potentially ineffective and suspect counterfeit version says, 'Evital Anticonceptivo de emergencia, 1.5 mg, 1 tablet.'" The product is manufactured by "Fluter Domull." CDER is requesting that persons "familiar with this product send an email to This e-mail address is being protected from spambots. You need JavaScript enabled to view it '; document.write( '' ); document.write( addy_text99982 ); document.write( '<\/a>' ); //--> This e-mail address is being protected from spambots. You need JavaScript enabled to view it to provide information or to ask questions about this product. 'Any information received is confidential and will be used only to help in FDA's effort to remove the potentially unsafe and ineffective versions from the US marketplace,'" the agency noted.
Reported by the American Association for Justice
Congress may relax FDA drug conflict rules
August 2, 2011
Reuters (8/2, Yukhananov) reports that, responding to complaints that it is too hard to find genuine experts to serve as FDA advisors, Congress is likely to relax the conflict-of-interest standard it set several years ago. Tighter conflict-of-interest rules adopted in 2007 bar FDA advisors from having even indirect financial ties to a related producer. Noting support among lawmakers at a recent Senate Health, Education, Labor and Pension hearing for easing the rule, the article adds that Dr. Janet Woodcock, head of the FDA's drugs center, told a House of Representatives hearing earlier this month that the agency has had "difficulty in recruiting highly qualified people" and "delays in having panels" due to the current rule. Last week, FDA Commissioner Margaret Hamburg told the Senate hearing that those calling for Congress to ease the current rule expressed "a valid concern."
Reported by the American Association for Justice
J&J unit to reduce acetaminophen dosage levels on OTC product labeling
July 28, 2011
The AP (7/28, Johnson) reported, Johnson & Johnson's McNeil Consumer Healthcare Division announced Thursday it is "reducing the maximum daily dose of its Extra Strength Tylenol pain reliever to lower risk of accidental overdose from acetaminophen," which is the "top cause of liver failure." According to Dow Jones Newswire (7/29, Lamar, Subscription Publication), McNeil said the change affects Extra Strength Tylenol sold in the US for which package labels starting this fall, will list the maximum daily dose as six pills (3,000 mg) down from eight daily pills (4,000 mg). Early next year, McNeil will reduce the maximum daily dose on labeling for Regular Strength Tylenol and other acetaminophen-containing products. CNN (7/28, Young) in its "The Chart" blog, reported that the J&J unit said acetaminophen is in "more than 600 over-the-counter and prescription medications including common pain relievers and fever reducers," such as NyQuil and Sudafed. Some people "accidentally exceed the recommended dose when taking multiple products at the same time, often...by not reading and following the dosing instructions," said McNeil VP Dr. Edwin Kuffner. Bloomberg News (7/29, Nussbaum) adds that McNeil said it is "working closely with fellow manufacturers to 'ensure consistency in dosing instructions' for acetaminophen." Notably, the FDA in January, announced limits on the agents "use in prescription pills," such as Percocet (acetaminophen and oxycodone) and Vicodin (acetaminophen and hydrocodone). ABC News (7/28, Francis) on its website noted that when the FDA "ordered drugmakers to reduce the amount of the painkiller in prescription medications by 50 percent, critics warned that prescription medications covered only 20 percent of the acetaminophen used in the US."
Reported by the American Association for Justice
AstraZeneca paid $647M to settle suits alleging antipsychotic caused diabetes
July 29, 2011
Bloomberg News (7/29, Feeley) reports, AstraZeneca Plc has "settled almost all lawsuits that claimed its antipsychotic drug Seroquel [quetiapine fumarate] causes diabetes in some users for a total of $647 million." AstraZeneca had "set aside the $647 million to resolve 28,461 suits alleging it knew Seroquel could cause diabetes in some users," the UK drug maker said in its second-quarter earnings report. Company officials said the reserve includes "money that may be used to settle about 250 unresolved cases." Miller Tabak & Co analyst Les Funtleyder said the fact that AstraZeneca was able to settle "for less than $1 billion" is a "real bargain when you look at what competitors such as Lilly have paid in settlements.'" Thus far, Eli Lilly has paid "at least $1.2 billion" to resolve similar lawsuits regarding Zyprexa (olanzapine).
Reported by the American Association for Justice
FDA issues warning letter regarding ISTA's promotional flyer for eye drops
July 28, 2011
Dow Jones Newswire (7/27, Dooren, Subscription Publication) reported that the Food and Drug Administration issued a warning letter to ISTA Pharmaceuticals Inc. on the grounds that the company's promotional material for Bromday (bromfenac ophthalmic solution) was false and misleading. Dow Jones quotes from a July 13 letter on the FDA website in which the agency concluded that a promotional flyer marketed by ISTA suggested Bromday is "safer than has been demonstrated"; omitted possible adverse events associated with using the eye drops; and neglected to caution against using the product while wearing contact lenses. Bromday was approved in October 2010 to treat pain and inflammation experienced by patients following cataract surgery.
Reported by the American Association for Justice
FDA warns concomitantly taking serotonergics with linezolid, methylene blue may be fatal
July 28, 2011
Bloomberg News (7/26, Peterson) reported that the FDA issued a safety communication Tuesday warning physicians that the Pfizer's Zyvox (linezolid) can cause a "potentially fatal central nervous system" reaction in patients concomitantly taking serotonin-specific reuptake inhibitor (SSRIs) and other serotonergic antidepressants. Cymbalta (duloxetine) and Paxil (paroxetine) as well as Pfizer's own SSRI Zoloft, are among the "29 psychiatric drugs" patients should stop temporarily when taking Zyvox, an antibiotic that treats infections such as MRSA and "nosocomial pneumonia." Conversely, Pfizer spokesperson Kristen Neese said the current US labeling for Zyvox "already includes prominent information" regarding potential "serotonergic interactions." Dow Jones Newswire (7/26, Dooren, Subscription Publication) reported that Zyvox inhibits an enzyme that help breakdown serotonin and concomitantly taking it with a serotonergic may cause toxic levels of serotonin to build up in the brain, the FDA explained in the alert. Separately, the agency also released a safety communication Tuesday alerting physicians that a similar adverse reaction may occur if the dye methylene blue is used in a diagnostic procedure in patients being treated with serotonergics.
MedPage Today (7/26, Gever) noted that the agency said both linezolid and methylene blue, which are "reversible monoamine oxidase inhibitors (MAOIs)," can cause serotonin syndrome even after serotonergics "have been stopped." The FDA said it had "received adverse event reports" for the two agents, including one death involving linezolid. However, the agency also stressed that patients taking serotonergics who present with "serious conditions" may still need the agents. For example, linezolid "may be required for patients with vancomycin-resistant enterococci" or certain MRSA infections. Similarly, methylene blue is needed for "emergency treatment of cyanide poisoning" and encephalopathy related to certain cancer drugs.
Medscape (7/26, Lowes) reported that in "nonemergency situations, most serotonergic drugs must be discontinued at least two weeks before the start of linezolid or methylene blue therapy"; and Prozac (fluoxetine) "requires a five-week lead time because of its longer half-life," according to the FDA.
Reported by the American Association for Justice
Zicam inventor will plead guilty to marketing unapproved flu remedy
July 28, 2011
The Los Angeles Times (7/27, Pfeifer) reported in its "Money & Company" blog that Zicam inventor Charles Hensley will "plead guilty to marketing an unapproved drug that he claimed in 2005 could prevent and treat flu." Hensley was indicted on 12 felony charges in May for marketing and selling Vira 38 without approval from the Food and Drug Administration. Hensley marketed the product online after failing to secure approval from Hong Kong authorities. The product was made for customers to apply with a swab inside their noses. The FDA ordered an end to production of the swabs in 2009 "because they can damage users' sense of smell." By pleading guilty to the charge, all others will be dismissed. A hearing has been scheduled for August 8.
Reported by the American Association for Justice
CDC says physicians improperly recommending breast, ovarian cancer screening
July 26, 2011
The Los Angeles Times (7/25, Brown) "Booster Shots" blog reported that, according to a CDC survey published in the journal Cancer, "physicians may not recommend screening often enough in women at high risk for breast and ovarian cancers...and that doctors may recommend screening too often for women at average risk of the diseases." The survey also found that "female physicians made the right recommendation more than males; ob-gyns did a better job than internists and family physicians. Urban doctors were more likely to comply with guidelines than rural doctors." The researchers recommended better education and development of genetic tools to help doctors assess patients' needs.
HealthDay (7/25, Dallas) added, "Women with mutations in the BRCA1 or BRCA2 gene or family histories of these mutations are at significantly greater risk for breast and ovarian cancer. Genetic counseling and testing are recommended for high-risk women because there are treatments that could significantly lower their risk for the diseases. These services are not recommended, however, for women who are not considered high-risk, because the harms of treatment outweigh the benefits, the study authors explained."
Reported by the American Association for Justice
FDA, EMA issue safety alerts for dronedarone
July 22, 2011
The New York Times (7/22, B7, Wilson, Subscription Publication) reports that yesterday, the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) "issued safety alerts on Thursday about Multaq [dronedarone], a drug approved two years ago to treat abnormal heart rhythms." The FDA "said a study of the drug in patients with a long-term form of the disease, known as atrial fibrillation, showed twice as many deaths as those who did not take the drug." In 2009, the drug "was approved for short-term arrhythmia lasting less than six months," with nearly 241,000 people in the US alone having received prescriptions since approval, the FDA noted.
Bloomberg News (7/21, Serafino) reported that the EMA "will finish its review" of Multaq "in September, the agency said" yesterday "in a statement on its website."
Dow Jones Newswire (7/21, Baba, Subscription Publication) reports that EMA will provide further guidance on the drug upon completion of its review. In the meantime, patients should not stop taking the drug without consulting their physician, and physicians who prescribe dronedarone should carefully monitor patients taking it, particularly making sure that patients are not going on to develop long-standing atrial fibrillation.
Reuters (7/22, Selyukh) reports that the FDA reviewed data derived from a clinical trial conducted by Sanofi-Aventis that the drugmaker halted on July 7.
According to HeartWire (7/21, Wood), the study, known as the PALLAS trial, "was stopped early when monitoring committees noted an increased risk of cardiovascular events among patients with permanent AF taking the drug compared with placebo."
MedPage Today (7/21, Peck) reported, "In the trial of more than 3,000 patients, there were 32 deaths in the dronedarone arm versus 14 in the placebo group (P=0.009), and for the combined endpoint of death or unplanned hospitalization, the difference was also highly significant, at 118 versus 81 (P=0.006)." In addition, "there were 17 strokes in the dronedarone arm versus seven in the controls (P=0.047)."
Reported by the American Association for Justice
FDA reviewing possible risk of esophageal cancer from bisphosphonates
July 22, 2011
The AP (7/22) reports the Food and Drug Administration said that it is investigating whether bisphosphonates increase the risk of "throat cancer after the publication of conflicting studies on the issue." The drugs are "routinely prescribed for osteoporosis in postmenopausal women and include brands like Fosamax (alendronate) and Boniva (ibandronate)."
Bloomberg News (7/22, Edney) reports the FDA "made the comments in an announcement today ahead of a meeting of agency advisers Sept. 9, where they will discuss the safety of the osteoporosis treatments." The FDA "is reviewing conflicting studies based on UK data that found no increased risk and a doubling in the risk of the throat cancer." Bloomberg News notes, "More than 40 million people either have osteoporosis in the US or are at high risk because of too low bone mass, according to the National Institutes of Health."
The NPR (7/21, Hensley) "Shots" blog reported, "A paper published in BMJ, the British Medical Journal, last year suggested the medicines could double the risk of such cancers." However, another paper that looked "at the same database," published in the Journal of the American Medical Association, "concluded there was no increased risk for either throat or stomach cancer."
Medscape (7/21, Lowes) reported that the FDA "stressed that it has not concluded that this class of medications increases the risk for esophageal cancer, and that it believes their ability to lower the risk for serious fractures in patients with osteoporosis outweighs their known potential risks." The agency is "advising physicians to instruct patients to carefully follow the directions for taking oral bisphosphonates, as esophagitis and other esophageal events have been reported for patients using the drugs incorrectly." Also, FDA is "telling physicians that there are not enough scientific data at this time to justify endoscopic screenings of patients who are taking oral bisphosphonates without any symptoms of esophageal problems." Reuters (7/22, Dey) also covers the story.
Reported by the American Association for Justice
Hail Creates Firestorm for State Farm
July 20, 2011
What began with an April 2006 hailstorm materialized into the most intense and significant litigation experience Indianapolis attorney Will Riley has had during his career.
Source: Indiana Lawyer
Seroquel label to carry new heart warning
July 18, 2011
The New York Times (7/19, Wilson, Subscription Publication) reports that "AstraZeneca is adding a new heart warning to the labels of Seroquel [quetiapine], its blockbuster antipsychotic drug, at the request of the Food and Drug Administration, company and agency officials said on Monday." The new "label, posted without fanfare last week on the FDA website, says Seroquel and extended-release Seroquel XR 'should be avoided' in combination with at least 12 other medicines linked to a heart arrhythmia" called prolongation of the QT interval. The revised "label also raises caution about use by the aged and people with heart disease."
Reported by the American Association for Justice
Judge blames Federal damage caps for inadequate award to Los Angeles train crash victims
July 15, 2011
The AP /New York Times (7/14, Subscription Publication) reported, "A judge on Thursday divided $200 million among victims of the disastrous 2008 collision of two trains but said he was forced to short-change them and make 'impossible decisions' because of a federal cap on damages." Victims of the Los Angeles collision between a Metrolink commuter train and a Union Pacific freighter were awarded damages according to their "degree of injury." Los Angeles Superior Court Judge Peter D. Lichtman said, "What was given to one victim had to be taken from another," and if the cases were tried separately, the verdict would've come close to or exceeded plaintiff attorneys' request for $320 million to $350 million. Metrolink and France-based Veolia Environment will pay the award. Veolia employed the engineer the National Transportation Safety Board found responsible for the crash.
Reported by the American Association for Justice
CPSC reduces acceptable lead levels for children's products
July 14, 2011
The Chicago Tribune (7/14, Gabler) reports the Consumer Product Safety Commission on Wednesday voted to decrease the amount of acceptable lead levels in children's products by two-thirds. The rule takes effect August 14 and says products "cannot contain more than 100 parts per million of lead." Commissioner Thomas Moore "said while the agency hasn't been able to quantify the benefits of reducing the limit from 300 parts per million to 100 parts per million, the scientific community has said there is no level of lead exposure to kids that has been deemed safe." Agency Chairman Inez Tenenbaum said "Consumers can rest assured that lead should be virtually nonexistent in toys and other children's products."
The AP (7/13) reported Republican commissioners, who dissented in the 3-2 vote said "the amount of allowable lead is already very low." Commissioners Anne Northup and Nancy Nord also said the commission "failed to undertake a solid review of whether all manufacturers, especially smaller domestic businesses, can make their products with the lower-lead level plastics, steel and other materials required as part of the new standard." Smaller companies "have said it could mean job cuts or failed companies because of increased testing costs, more expensive materials and products that may have to be cleared from store shelves and thrown away on Aug. 14."
Bloomberg News (7/13, Plungis) reported the vote "comes four years after the discovery of lead paint in toys from China that prompted legislation expanding the safety agency's powers." The 2008 Consumer Product Safety Improvement Act "required the agency to adopt the 100 parts per million limit for children's products unless it could establish it wasn't technologically possible for manufacturers to reach that level. Even some Democrats who voted for the tougher limits said Congress should have given the agency more flexibility to apply the standard only on new products, rather than on items already in store inventories."
Reported by the American Association for Justice
FDA issues warning on vaginal mesh implants
July 14, 2011
In a front page story, the Boston Globe (7/14, A1, Kotz, Weisman) reports, "Women who have vaginal surgery to fix a common gynecologic condition called pelvic organ prolapse may wind up with more problems than benefits if a plastic mesh is used, according to a safety communication issued yesterday by the Food and Drug Administration."
The Los Angeles Times (7/14, Mai-Duc) reports that the "FDA says a review of industry literature and patient reports has shown little evidence that the device improves pelvic organ prolapse, in which a woman's uterus, bladder or rectum can slip out of place."
The AP (7/13) reported, "About 75,000 women had prolapse surgery with mesh inserted through the vagina last year, and more than 200,000 women had the procedure for incontinence." Between 2008 and 2010 the FDA "received more than 1,500 reports of complications from women undergoing vaginal prolapse surgery with mesh, up 500 percent from the prior three years. There were fewer complications among incontinence patients." The FDA's "warning applies only to mesh for prolapse. The agency is also reviewing the use for incontinence, though side effects have not been as frequent."
The Minneapolis Star Tribune (7/14, Moore) reports, "The most-common complication is when the mesh becomes exposed or protrudes from the tissue, as well as pain, infection, bleeding and urinary problems. Three deaths have been associated with prolapse repair using mesh -- two bowel perforations and one hemorrhage, according to" the FDA. "Dr. William Maisel, the FDA's deputy director and chief scientist in the device division, said there are 'clear risks' associated with the mesh. 'The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed about potential complications.'"
HealthDay (7/13) reported, "The FDA plans to convene an independent panel of experts to meet and discuss the issue in early September. 'Input from the clinicians, manufacturers and other experts will help the FDA better understand the safety and effectiveness of surgical mesh for [pelvic organ prolapse and stress urinary incontinence] repair, including any changes that would improve our oversight,' Maisel said."
Reported by the American Association for Justice
Physicians may not be following heart-attack treatment guidelines
July 13, 2011
Bloomberg News (7/12, Cortez) reported that physicians "aren't following national guidelines for treating heart attack survivors, according to a study that found many receive an artery-clearing procedure even though previous research shows it offers no benefit." Investigators found that "the percentage of patients getting treatment didn't change after a 2006 trial dubbed OAT found it failed to reduce the risk of subsequent heart attacks, heart failure or death." And, "it didn't change after guidelines issued the next year by the American Heart Association and the American College of Cardiology said the procedure shouldn't be performed, according to the report" published in the Archives of Internal Medicine.
Reuters (7/12, Joelving) reported that the research adds to increasing worries about the potential overuse of stents.
HealthDay (7/11, Preidt) reported that investigators "analyzed data from 28,780 patient visits at 896 US hospitals between 2005 and 2008." Altogether, "PCI was performed on 11,083 patients before the OAT study was published, 7,838 between the release of the study and guideline changes, and 9,859 after the guidelines were revised, the investigators found." The researchers, after factoring "in other variables...found no overall significant decrease in the monthly rate of PCI performed for coronary blockages either after the OAT results were published or after the guidelines were updated."
Reported by the American Association for Justice
Lawsuits mounting over alleged health risks of Yaz contraceptive
July 12, 2011
The Star-Ledger (7/12, Todd) reports that "thousands" of plaintiffs "are alleging Bayer did not provide adequate warnings about the health risks associated with Yaz (drospirenone and ethinyl estradiol), and they are blaming the drug for causing blood clots, heart attacks, strokes and, in some cases, sudden deaths." Over "900 lawsuits have been filed in Bergen County - one of four courts where the mass tort litigation will be heard. Hundreds of other cases are filed in courts in Philadelphia, California and Illinois." When Yaz and its predecessor, Yasmin (estrogen ethinyl estradiol and drospirenone), "were approved by regulators, the pills were considered an advance over older forms of oral contraceptives because they were taken for 24 days rather than the usual 21, which was believed to benefit women because it created less hormonal fluctuation. But early on, there were concerns about the health risks associated with drospirenone."
Reported by the American Association for Justice
Summer spike in medical errors may be a real phenomenon
July 12, 2011
The New York Times (7/12, D6, Rabin, Subscription Publication) reports in "Vital Signs," that "until recently there was little proof that medical errors spike in the summer when new medical trainees start working at teaching hospitals - a phenomenon known as the 'July effect.' But a new review has found evidence that death rates do increase in July, and that many patients stay in the hospital longer than in other months."
The Wall Street Journal (7/11, Hobson) "Health Blog" reported that for the review, published in the Annals of Internal Medicine, investigators looked at data from 39 different studies.
The Boston Globe (7/11, Kotz) "Daily Dose" blog reported that "the best-quality studies reviewed found that patients treated in July had a four to 12 percent increase in mortality risk compared to those treated in the spring before the staffing change." Meanwhile, "Some of the studies also indicated an increase in medical errors and complications from procedures, but the data weren't strong enough to draw firm conclusions."
Reported by the American Association for Justice
Former Contractor Victorious After State Farm Legal Defeat
July 8, 2011
Source: The Indy Channel
Attorneys lining up to pursue J&J in lawsuits over hip joints
July 8, 2011
Under the headline "Hip Joints Set Off New Rush To Court," the Wall Street Journal (7/8, Rockoff, Searcey, Subscription Publication) says attorneys are lining up to sue Johnson & Johnson over its DePuy Orthopaedics Inc. metal-on-metal hip joins. The company stopped manufacturing them in 2009, and later recalled them, but it is fighting the lawsuits and charges in them. Some 1,000 already have been filed in both federal and state courts. The Journal says that by some estimates the company could face $1 billion or more in litigation- related costs. Some of the cases have been consolidated in federal court in Ohio, and some plaintiff attorneys are pushing for class-status for the suits.
Reported by the American Association for Justice
FDA releases graphic smoking warning labels
July 6, 2011
American Medical News (7/4, Moyer) reported that the FDA released "nine text and graphic image health warnings that must appear on all cigarette packs, cartons and advertisements by September 2012," including "images of a man smoking through a tracheotomy hole and a dead man with a surgery-scarred chest." Philip Morris protested, arguing that the government would be compelling a private company to advertise a message that it did not choose, which they argue violates the First Amendment. Health and Human Services Secretary Kathleen Sebelius said, "These labels are frank, honest and powerful depictions of the health risks of smoking, and they will help encourage smokers to quit and prevent children from smoking."
Reported by the American Association for Justice
Chantix linked to increased risk of heart attack, stroke
July 5, 2011
A study linking use of the drug Chantix (varenicline) to increased heart risks garnered significant news coverage, with two networks carrying reports on their respective nightly news programs. The CBS Evening News (7/4, lead story, 3:00, Pelley) reported that research "raises new safety questions about" Chantix (varenicline). NBC Nightly News (7/4, story 9, 0:30, Snow) reported that a study published in the Canadian Medical Association Journal suggests that "patients who take Chantix are increasing their risk of heart problems including heart attacks and strokes, even if they have no prior history of heart disease." The New York Times (7/5, B3, Wilson, Subscription Publication) reports that the "study...compiled data from 14 random, blinded, placebo-controlled clinical trials that tracked cardiovascular outcomes." Researchers "found 52 out of 4,908 people taking Chantix had serious cardiovascular events, a rate of 1.06 percent, compared with 27 out of 3,308 people taking a placebo, a rate of 0.82 percent. While the absolute difference is only 0.24 percent, the weighted, relative difference is 72 percent." The Wall Street Journal (7/5, Burton, Subscription Publication) reports the research comes just a month after the FDA warned that Chantix may be linked to increased risk of cardiovascular problems in individuals with heart disease. Bloomberg News (7/5, Randall) reports that the FDA "warned in 2009 that the medicine may increase suicides and erratic behavior." The FDA "is examining the" new "study and may consider new warnings, Curtis Rosenbraugh, director of the agency's office of drug evaluation, said in an interview." The Baltimore Sun (7/5) reports that FDA officials "have...asked the drug's maker, Pfizer, to conduct another review and to plan its own study." The agency "also has asked Pfizer to conduct a large, randomized study of possible psychiatric effects."
Reported by the American Association for Justice
Antidepressant use during pregnancy associated with increased risk of autism
July 5, 2011
The Wall Street Journal (7/5, D3, Wang, Subscription Publication) reports that expectant mothers who take antidepressant medication during their pregnancy may have an increased risk of giving birth to a child with autism, according to a study published online July 4 in the Archives of General Psychiatry. CNN /Health.com (7/5, Harding) reports that children exposed to selective serotonin reuptake inhibitors (SSRIs) "during the first trimester were nearly four times as likely to develop an autism spectrum disorder (ASD), compared with unexposed children, according to the study" of 298 youngsters with an ASD and 1,507 youngsters without an ASD identified from the Kaiser Permanente patient database. After adjusting for confounding factors, "the researchers found that any exposure to the drugs in the womb increased the risk of ASD diagnosis 2.2-fold, while first-trimester exposure increased the risk 3.8-fold." On its website, ABC News (7/4, Carollo) reported, "that risk was even four times higher in women who took SSRIs during their first trimester." However, "though these numbers may seem alarming, the authors warn that they shouldn't be over- interpreted." ABC News added, "in the general population, they wrote, 'the fraction of cases of ASD that may be attributed to use of antidepressants by the mother during pregnancy is less than three percent...and it is reasonable to conclude that prenatal SSRI exposure is very unlikely to be a major risk factor for ASD.'" HealthDay (7/4, Goodwin) reported, "though the risks and benefits taking any medication during pregnancy should be carefully considered, Dr. Natalie Meirowitz, chief of the division of maternal fetal medicine at Long Island Jewish Medical Center in New Hyde Park, advised expectant mothers who suffer from depression not to toss their medications." This is "because depression itself poses a risk to mother and baby. Depressed women may self-medicate with drugs and alcohol, fail to eat right and keep their prenatal appointments, and be unable to care for their baby after delivery, Meirowitz said." Reuters (7/5, Steenhuysen) Reuters (7/5, Steenhuysen) quotes Thomas Insel, MD, director of the National Institute of Mental Health, as saying in a telephone interview, "there are real risks to not being treated for a serious illness like depression. You have to weigh the options." He added, "a threefold increase in risk is not insignificant. It is worth taking that into account with other factors."
Reported by the American Association for Justice
Government releases graphic warning labels for cigarettes sold in US
June 22, 2011
The announcement Tuesday of new graphic warning labels for cigarettes sold in the US is gaining widespread media attention, including reports on two evening network newscasts, much of it highlighting statements from Secretary Sebelius touting them as "frank, honest and powerful depictions of the health risks of smoking." Appearing on the CBS Early Show (6/21, 7:35 a.m. EDT), Secretary Sebelius said the effort "is really aimed at making sure kids don't start in the first place. ... But also, to make sure that adults who want to stop, we give them some help. So the graphic warnings also contain 1-800-QUIT number to make a case to adults that it's never too late to stop smoking." In a report preceding the Sebelius interview, CBS (6/21, 7:33 a.m. EDT) reported, "For decades, a written warning was required on cigarette packaging. But anti-smoking advocates say the new warnings are long overdue, and will help target the most vulnerable: the young and uneducated." FDA Commissioner Margaret Hamburg was shown on NBC Nightly News (6/21, story 3, 2:30, Williams) saying, "Kids who are under the impression that smoking is cool or glamorous will be confronted by a very different reality." The CBS Evening News (6/21, story 8, 135, Pelley) reported that the labels' "graphic images of rotting teeth, damaged lungs, and even a smoker's corpse, shocked the longtime smokers we showed them to, like Michael Magistro."
In an article published in some form by hundreds of sources, the AP (6/22, Felberbaum) reports that with a decline in the US smoking rate having "come to a standstill, the government is hoping the in-your-face labels will go further than the current surgeon general warnings toward curbing tobacco use, which is responsible for about 443,000 deaths a year in the US." The AP adds that the new warnings were "required in a 2009 law that, for the first time, gave the federal government authority to regulate tobacco. Tuesday's announcement follows reviews of scientific literature, public comments and results from an FDA-contracted study of 36 labels proposed last November."
The Hill (6/22, Pecquet) "Healthwatch" blog highlights the support expressed for the new warnings by a number of public health groups, including the American Heart Association, which said in a statement that "warnings represent an aggressive and welcome approach to reducing smoking rates that have leveled off in recent years as tobacco companies continue to launch campaigns to entice new smokers and maintain current customers."
Also highlighting praise from health advocacy groups, the New York Times (6/22, B1, Wilson, Subscription Publication) adds that "the four leading tobacco companies were all threatening legal action, saying the images would unfairly hurt their property and free-speech rights by obscuring their brand names in retail displays, demonizing the companies and stigmatizing smokers. The government won one case last year in a federal court in Kentucky on its overall ability to require larger warning labels with images; the specific images released Tuesday are likely to stir further legal action."
National Journal (6/22, Brownstein, Subscription Publication) notes that "Sebelius said that FDA can change the pictures to keep them freshly horrifying. 'So, immediately after the launch of the first set of nine, we'll begin the studies to make sure that we are keeping people sensitized, and we have the authority then to move to a new set of labels,' she said."
Asked on NPR's All Things Considered (6/21) about the warnings that are being replaced, Hamburg said, "Various studies showed that they had lost their power and effect. And these warning labels are going to be quite different. For one thing, they're going to be much larger and more prominent, taking up half of the cigarette pack. And they will be in bold color with clear statements with respect to the health risks." On its "The Oval" blog, USA Today (6/22, Jackson) quotes Hamburg saying that the new warnings will mark a "dramatic difference in what cigarette packages look like."
CNN (6/22, Young) reports on its website that Sebelius said "a stall in the downward trend of smoking in America, particularly among young people, prompted President Barack Obama to renew the focus on getting Americans to kick the habit or never start smoking in the first place. It is the first government-mandated label change for cigarettes in 25 years, she said, adding that a major motivation was targeting young people from wanting to smoke."
CQ Healthbeat (6/22, Adams, Bunis, Subscription Publication) quotes Sebelius saying that the warnings "will encourage smokers to quit, and prevent children from smoking. President Obama wants to make tobacco-related death and disease part of the nation's past, and not our future." CQ adds that tobacco companies including Philip Morris USA Inc. have questioned the constitutionality of the warnings.
Bloomberg News (6/22, Peterson) reports "the FDA estimates the labels will reduce the number of US smokers by 213,000 people in 2013, Lawrence Deyton, director of the agency's Center for Tobacco Products, said today at a news conference at the White House."
The Wall Street Journal (6/22, McKay, Kesmodel, Subscription Publication) reports that how effective the labels will be is unknown, but more than a quarter of survey respondents in 13 of 14 countries said in a recent survey that similar warnings made them consider quitting, according to the CDC.
In a Marketplace Public Radio (6/21) report on the new warnings, HHS Deputy Secretary Bill Corr was heard saying, "Despite the many health risks that are now well known, youth and adult smoking rates that had been dropping have stalled." Corr and assistant secretary Howard Koh told New England Cable News (6/22) that "the nine images were selected after a year-long review because they are seen as carrying the strongest message encouraging adults to quit and discouraging teenagers from taking up the habit. Corr said the experience of nearly 30 other countries with similar labels show they can have a significant impact reducing smoking rates."
Prevalence of graphic warnings in other countries highlighted. The AP (6/21, Gibson) adds that "more than 40 countries around the world already require warnings as graphic as the new US labels -- if not more so." While noting that "it's impossible to attribute reduced smoking rates to any single cause," it adds that public health officials in Canada, Brazil, Thailand and elsewhere claim that graphic images required there have helped reduce smoking.
Reported by the American Association for Justice
AMA issues 2011 report card on commercial health insurers
June 21, 2011
The AP (6/21) reports that the American Medical Association (AMA), "the nation's largest doctors' group, says about one in five payments of medical claims by commercial health insurers is inaccurate, shortchanging physicians." Yesterday, the AMA "released its annual report card on insurers," saying that "eliminating mistakes would save doctors and insurers $17 billion a year."
"The AMA said commercial health insurance companies have an error rate of 19.3 percent, up two percentage points from last year's report," the Chicago Tribune (6/21, Japsen) reports. "Improving claims processing could save patients money and improve medical care by reducing hassles physicians have when they are forced to haggle with health plans over payments or other issues. The AMA said the report is designed to hold insurance companies accountable."
Modern Healthcare (6/20, Zigmond, Subscription Publication) reported, "The 2011 report card is based on a random sampling of about 2.4 million electronic claims for approximately four million medical services submitted in February and March 2011 to Aetna, Anthem Blue Cross Blue Shield, Cigna, Health Care Service Corp., Humana, the Regence Group, UnitedHealthcare and, for comparison, Medicare, according to the AMA. The claims were gathered from more than 400 physician practice groups in 80 medical specialties in 42 states." Commenting on the 2011 report card, "Robert Zirkelbach, spokesman for America's Health Insurance Plans, said in an e-mailed response that insurers and providers share the responsibility of improving claims payment accuracy and efficiency."
Healthcare IT News (6/20) reported, "Dramatic reductions in denial rates have occurred since last year at Aetna, Anthem Blue Cross Blue Shield, Health Care Service Corporation and UnitedHealthcare, which cut its denial rate by half to 1.05 percent." Again, "CIGNA maintained its industry leading low denial rate of 68 percent." Notably, "lack of patient eligibility for medical services continues to be the most frequent reason for denials."
Reported by the American Association for Justice
Sebelius, CMS officials announce technology to fight Medicare, Medicaid fraud
June 18, 2011
The Philadelphia Inquirer (6/18, Sell) reported Secretary Sebelius joined Center for Medicare and Medicaid Services leaders Friday in Philadelphia to discuss a system coming July 1 that "is supposed to enable the government to collect and analyze information so it can spot potential" Medicare and Medicaid "fraud rather than simply evaluate one claim at a time." It "will use technology similar to that used by banking and telecommunications companies to spot fraud." Sebelius said at Friday's news conference that officials "wanted to be able to spot the doctor claiming to be in six cities billing for the same procedure on the 16th of June."
CQ HealthBeat (6/18, Adams, Subscription Publication) reported Friday's announcement came as Secretary Sebelius "and Attorney General Eric H. Holder Jr. were holding an anti-fraud summit in Philadelphia, the fifth in a series of meetings that they have held over the past year and a half. The Northrop Grumman predictive modeling tool will assign risk scores to claims and alert CMS officials to those that seem unusual because they differ from patterns."
The AP (6/17, Alonso-Zaldivar) reports that, up to now, Medicare "has basically paid claims first and asked questions later in a system dubbed 'pay and chase.' The technology upgrade should help deter flagrant abuses."
Reported by the American Association for Justice
COPD mist inhaler may increase risk for early death
June 16, 2011
Bloomberg News (6/15, Doherty) reported, "Boehringer Ingelheim GmbH and Pfizer Inc. (PFE)'s Spiriva mist inhaler" for chronic obstructive pulmonary disease (COPD) may "raise the risk of an early death," according to a review of five studies published in the British Medical Journal. Although the Food and Drug Administration "last year said a two- year review didn't indicate Spiriva increased the risk of heart attack and stroke," earlier studies had "suggested a potential risk."
HealthDay (6/14, Preidt) reported that the five studies analyzed by Dr. Sonal Singh, an assistant professor of general internal medicine at the Johns Hopkins University School of Medicine, and colleagues included "more than 6,500 patients." The researchers "compared the mist inhaler with Spiriva against a mist inhaler with a placebo." They found that patients who used the inhaler with Spiriva were "52 percent more likely to die than those who used the inhaler with the placebo."
Reported by the American Association for Justice
Diabetes treatment may raise bladder cancer risk, FDA warns
June 16, 2011
The Wall Street Journal (6/16, Dooren, Subscription Publication) reports the Food and Drug Administration said the use of Takeda Pharmaceutical's diabetes drug Actos (pioglitazone hydrochloride) for more than one year might increase the risk of bladder cancer.
Bloomberg News (6/16, Peterson) reports, "A five-year interim analysis of data from a decade-long company- sponsored study showed a greater likelihood of bladder cancer in patients who took the drug for the longest periods of time, and at the highest cumulative doses," the FDA said in a safety announcement, which "updated preliminary findings released nine months ago." The FDA "had said Sept. 17 that while it hadn't found a statistically significant link between Actos and bladder cancer, the risk appeared to be higher in patients who took the drug for the longest duration, and at the highest cumulative doses." According to the announcement, the median duration of therapy was 24 months for patients treated with the drug. "Treatment times ranged from 2.4 months to 8.5 years."
Reported by the American Association for Justice
Lawsuit provides inside look at drug marketing
June 14, 2011
McClatchy (6/13, Adams) reported on Solvay Pharmaceuticals' push for off-label sales of testosterone replacement drug AndroGel. In 2000, when the Food and Drug Administration approved it to treat AndroGel hypogonadism, the company announced that the "market was 'four to five million American men.' But by 2003, when drug was being pushed by its corporate managers, the number drifted to 'up to 20 million men,'" according to information in a whistleblowers lawsuit "recently unsealed by a federal court in Texas." The current whistleblower lawsuit actually involves "three of Solvay's drugs -- AndroGel, a blood pressure drug, and a mental health drug -- and provides an inside look at the world of corporate drug marketing." Dozens of internal company documents, "emails and sales presentations were filed in the case, documenting how the company and its sales representatives sweet-talked, cajoled and even paid fees to the doctors in their territories."
Reported by the American Association for Justice
Long-term, heavy cell phone use may raise risk of brain tumors slightly
June 13, 2011
In continuing coverage, HealthDay (6/10, Reinberg) reported that the debate over whether "cell phones might cause brain tumors continues, as a new international study finds a small risk among people who are heavy cell phone users or who have used them for a long time." For the new study, which was published in the June 10 online edition of Occupational and Environmental Medicine, researchers collected data on "1,229 people with brain tumors and 3,673 people without brain tumors." They found that a higher risk of "developing a glioma among those who used their cell phones for 10 years or more." However, even with these potential "increased risks, the incidence of brain tumors is fairly rare. 'Brain tumor incidence rates have been flat to slightly declining over the last 20 years,'" said Dr. Otis Brawley from the American Cancer Society, who "was not involved with the latest research."
Reported by the American Association for Justice
Updated government carcinogens report links two common chemicals with cancer risk
June 13, 2011
On its website, ABC News(6/10, Murray) reported that HHS added "eight more substances to its 'known human carcinogen' or 'reasonably anticipated to be carcinogen' lists today, one week after a World Health Organization study concluded that cell phones may cause cancer." The Los Angeles Times (6/10, Dennis) "Booster Shots" blog reported that formaldehyde "now officially falls into the 'known to be a human carcinogen' category," and styrene can now "officially be described as 'reasonably anticipated' to be cancer-causing," according to the Department of Health and Human Services' updated " Report on Carcinogens." Carcinogens used in everyday products. In a front-page story, the New York Times (6/13, A1, Harris, Subscription Publication) reports that the federal government on Friday issued warnings about the "two materials used daily by millions of Americans." The report by NIH's National Toxicology Program found evidence that styrene, which is used in "boats, bathtubs, and in disposable foam plastic cups and plates," may increase the risks of "cancer of the pancreas and esophagus," the report found. Consumers can be exposed to styrene from the "fumes of building materials, photocopiers and tobacco smoke." According to the AP (6/11), NIH says the greatest exposure to styrene is "through cigarette smoking." The Time (6/10, Walsh) "Healthland" explained that the report found that "concerning amounts of formaldehyde could be encountered in plywood and particle boards, as well as in hair salons and in mortuaries," and the exposure is "most intense" among workers in "some manufacturing plants." With formaldehyde and styrene, the government also added captafol, cobalt-tungsten carbide, "certain inhalable glass wool fibers, o-nitrotoluene," and riddelliine to its twelfth report, bringing the total to 240 carcinogens. Notably, studies of mortuary workers "exposed to high levels of formaldehyde have shown increased incidences of certain kinds of rare nasal cancers." The New York Daily News (6/10) noted that the report also linked formaldehyde to leukemia. The American Cancer Society "said consumers should not worry about cups or food containers, but should shelve personal products with formaldehyde." The Washington Post (6/11, Stein) noted that most of the cancer risk evidence "came from people exposed to relatively high levels in industrial settings. 'A listing...does not by itself mean that a substance will cause cancer,'" saidDr. John Bucher, associate director of the National Toxicology Program. Moreover, Dr. Bucher said the updated listings "do not trigger any immediate new restrictions on the substances, but other government agencies may use the information in the future as part of their regulatory decisions." He said individuals can use the list to "make personal choices," noting that most people's "routine exposure to the newly listed substances was probably low." Bloomberg News (6/10, Young) pointed out that aristolochic acids, which are "found in herbal products used to treat arthritis and gout," were also listed as carcinogens, because they "can cause bladder or urinary-tract cancer in people with kidney disease." Meanwhile, American Chemistry Council CEO Cal Dooley released a statement saying the report "makes 'unfounded classifications' about formaldehyde and styrene that will scare consumers," and the American Composite Manufacturers Association disputed the styrene and cancer link with a statement saying, "styrene-based composite material system has been used safely for over 60 years."
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Many heart failure patients may not receive recommended therapies
June 7, 2011
The National Journal (6/2, Fox, Subscription Publication) reports, "Medicaid will no longer pay hospitals or doctors for certain preventable illnesses and injuries, such as operating on the wrong body part, the Health and Human Services Department said Wednesday." In a statement, Donald Berwick, administrator of the Centers for Medicare and Medicaid Services, said, "These steps will encourage health professionals and hospitals to reduce preventable infections, and eliminate serious medical errors." The Journal points out that Medicare "already has such a policy -- one widely recommended by health care experts as a way to help prevent expensive and deadly errors." "Now this concept will be extended to Medicaid," CQ (6/2, Norman, Subscription Publication) reports. "Under the healthcare law (PL 111-148, PL 111-152), the curb on payments for preventable conditions must also apply to Medicaid." In other words, "states won't be allowed to pay providers including hospitals, doctors and other health care organizations if patients develop conditions that are deemed reasonably preventable." Kaiser Health News (6/1, Galewitz) reported, "Currently, about 21 states have such a nonpayment policy," but "the 2010 federal health law, in effect, expands the ban nationwide. The rule published [yesterday] gives states until July 2012 to implement it." However, some medical groups have reservations about this policy. Kaiser Health News quoted written comments made by Michael Maves, MD, CEO of the American Medical Association, to the CMS three months ago. Maves wrote, "Simply not paying for complications or conditions, that, while extremely regrettable, are not entirely preventable, is a blunt approach that is not effective or wise for patients or the Medicare or Medicaid program." Writing in the Forbes (6/1) "Health Dollars" blog, David Whelan focused on possible unintended consequences of the new rule proposed by the CMS that "would modify the Inpatient Prospective Payment System." Whelan pointed out that "the new payment plan assumes that changing a whole industry is as simple as turning a few knobs and pushing a few buttons on the Medicare dashboard. Implementing such a scheme will be extremely difficult, possibly unfair and will most definitely increase the cost of health care rather than save money." Whelan contended that Medicare currently does not have the necessary experience to make clinical judgments affecting patients. He also voiced concern that hospital systems would have to merge as a result of the proposed rule, thereby setting up "powerful health care oligarchies." At least 34 patients died as a result of preventable mistakes in Oregon hospitals in 2010. The Oregonian (6/2, Rojas-Burke) reports, "At least 34 patients died as a result of preventable mistakes in Oregon hospitals last year, the same number reported in 2009 to the Oregon Patient Safety Commission." Although "the number is small in comparison to the tens of thousands of people safely restored to health in hospitals each year, it is one of several indicators of stalled progress in reducing serious medical errors.
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International panel of experts categorizes cell phones as "possibly carcinogenic"
June 1, 2011
ABC World News (5/31, lead story, 3:10, Sawyer) reported, "An important new alert about the safety of cell phones and the possible risk of cancer, brain cancer in particular...comes from the World Health Organization." NBC Nightly News (5/31, lead story, 3:10, Williams) reported, the WHO "statement labeling cell phones as a possible carcinogenic hazard comes from a panel of 31 scientists." According to the AP (6/1, Cheng), the statement was "issued in Lyon, France, on Tuesday by the International Agency for Research on Cancer" (IARC) after a "weeklong meeting" during which experts reviewed "possible links between cancer and the type of electromagnetic radiation found in cellphones, microwaves and radar." The IARC classified cellphones in "category 2B, meaning they are possibly carcinogenic" to humans. The assessment now "goes to WHO and national health agencies for possible guidance on cellphone use." The Wall Street Journal (6/1, Martin, Hobson, Subscription Publication) reports that the IARC working group did not conduct new research. Instead, the panel reviewed existing literature that focused on the health effects of radio frequency magnetic fields. Its findings are slated to be published July 1 in Lancet Oncology. The New York Times (5/31, Parker-Pope, Barringer, Subscription Publication) "Well" blog noted that the panel's decision to "classify cellphones as 'possibly carcinogenic' was based largely on epidemiological data showing an increased risk among heavy cellphone users of a rare type of brain tumor called a glioma." Most "major medical groups," including the National Cancer Institute, have "said the existing data on cellphones and health has been reassuring." Earlier this year, the Journal of the American Medical Association "reported on research from the National Institutes of Health, which found that less than an hour of cellphone use can speed up brain activity in the area closest to the phone antenna." The Los Angeles Times (6/1, Roan, Gabler) reports that a 2010 study (pdf) published in the International Journal of Epidemiology found a "40% increase risk of gliomas for people who used a cellphone an average of 30 minutes a day over a 10-year period." The Orange County (CA) Register (5/31, Brennan) reported that the literature review also indicated "long-term or heavier use" of cell phones may increase risk for a "cancer type called acoustic neuroma." Bloomberg News (5/31, Kresge) reported that the most recent research "considered dated to 2004, and exposure levels from handsets have dropped over time," said IARC Working Group Chair Dr. Jonathan Samet from the University of Southern California. The age of the studies also means the participants "had used their phones for no more than 10 to 15 years, leaving open the question of the effect of longer-term exposure," he noted. On the CBS Evening News (5/31, lead story, 2:50, Smith), Dr. Samet was shown saying, "The jury is not clear, it's not an established carcinogen and for those who want to take steps to reduce their exposure, they can do it." BBC News (6/1, Gallagher) reports, "Ed Yong, head of health information at Cancer Research UK, said: 'The WHO's verdict means that there is some evidence linking mobile phones to cancer but it is too weak" to draw strong conclusions. WebMD (5/31, DeNoon) reported that the finding "means that research is urgently needed. ... It's important to put the possible risk into context. Kurt Straif, MD, PhD, MPH, head of the IARC Monographs Program," noted that the IARC currently lists "some 240 agents as 'possibly carcinogenic,' including dry cleaning fluid and some commonly used pesticides." Utah's Deseret Morning News (5/31, Hicken) quoted IARC Director Christopher Wild as saying, pending the availability of long-term research, "it is important to take pragmatic measures to reduce exposure such as hands-free devices or texting." CNN (5/31, Dellorto) noted that manufacturers of "many popular cell phones already warn consumers to keep their device away from their body and medical experts say there other ways to minimize" cell phone radiation. For example, the Apple iPhone 4 "safety manual says users' radiation exposure should not exceed FCC guidelines: 'When using iPhone near your body for voice calls or for wireless data transmission over a cellular network, keep iPhone at least 15 millimeters (5/8 inch) away from the body.'" Meanwhile, the National Journal (6/1, Brownstein, Subscription Publication) reports that the American Cancer Society estimates that "around 22,000 Americans will be diagnosed with malignant tumors of the brain or spinal cord and 13,070 will die. Gliomas account for about 1.3 percent of all cancers in the US." HealthDay (5/31) noted that globally, an estimated "five billion cell phones are in use. 'The number of users is large and growing, particularly among young adults and children,'" the IARC said in a news release.
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Administration's patient safety initiative lauded
May 31, 2011
American Medical News (5/30) editorialized, "The federal government's new Partnership for Patients initiative," unveiled by the Department of Health and Human Services last month, "has all the markings of becoming a landmark event in the patient safety movement." It "aims to cut preventable hospital- acquired conditions 40% by 2013, translating into 1.8 million fewer injuries to patients. During the same period, it hopes to reduce unnecessary returns to the hospital by 20%, preventing more than 1.6 readmissions." Notably, the "American Medical Association is among" the more than 1,600 groups and hospitals that have pledged to support the initiative. Hospitals under increased pressure to reduce preventable infection rates. On its "Weekend Edition Saturday" program, NPR (5/28, Varney) reported that although it has been "more than a decade since a panel of top scientists declared hospital safety" as a national priority, about "90,000 patients still die each year from preventable infections resulting from routine surgeries and hospital care," according to the Centers for Disease Control and Prevention. However, under legislation in more than "two dozen states and new Medicare rules that went into effect earlier this year," hospitals are now required to report infections "or pay a penalty. That's left hospital administrators weighing the cost of 'fessing up against the cost of fines."
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Atlanta hospital worker exposed nearly 700 patients, 100 employees to TB
May 31, 2011
CNN (5/27) reported that nearly "700 patients at Emory University Hospital in Atlanta have been exposed to tuberculosis after coming in contact with a hospital employee carrying the disease," hospital spokesperson Lance Skelly said Thursday. He said the Georgia Department of Community Health and the hospital have "identified 680 patients who were exposed to tuberculosis between November and February." The Atlanta Journal-Constitution (5/28, Williams) noted that an "additional 100" hospital employees were also "exposed by a respiratory technician who unknowingly carried the disease." The worker, who had a "persistent cough for weeks, was diagnosed April 17," according to Skelly.
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Approval of genetically modified crops may raise consumers' concerns
May 25, 2011
The Chicago Tribune (5/25, Eng) reports, "With an unprecedented number of genetically modified crops being greenlighted by the Obama administration in recent months...some advocates say the issues may be reaching the awareness of consumers" Meanwhile, although "the Food and Drug Administration has allowed the sale and planting of genetically modified foods for 15 years, it has never required premarket safety evaluations of the foods." Consumers union calls for labeling GM foods. In the Huffington Post (5/25), Jean Halloran, Director of Food Policy Initiatives at Consumers Union, writes, "The FDA is deliberating whether or not it will approve, for the first time, genetically engineered (GE) animals into the food supply, labeled or not." Halloran predicts it is likely the FDA "will approve the raising and selling of GE salmon--without labeling--in the very near future," but Consumers Union, opposes this "on the grounds that the agency's safety assessment was woefully inadequate." According to the advocate, "FDA allowed Aquabounty, the company developing the GE salmon, to declare that there was no increase in allergy-causing potential based on data from exactly six engineered fish--even when the data from those fish suggested there might be a problem." Halloran calls for genetically engineered food to be labeled so consumers can "know what they are eating and...decide for themselves what to put on their plates."
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FDA warns against adding thickening agent to breast milk, formula given to premature babies
May 24, 2011
The AP (5/21) reported, "The Food and Drug Administration is warning parents and healthcare providers to stop using the SimplyThick additive in the breast milk and formula of premature babies after the deaths of two infants who were given it." The FDA "said the product, a thickening agent that helps infants with swallowing, may cause a potentially life-threatening intestinal disorder," necrotizing enterocolitis. The Los Angeles Times (5/20, Maugh) "Booster Shots" reported that the FDA "said it has recently received 15 reports of infants who received the product developing necrotizing enterocolitis, with two deaths." Symptoms of the disorder include the appearance of a "bloated abdominal area, the appearance of illness, feeding intolerance, greenish-tinged vomiting and bloody stools." Premature infants "still in the hospital and those who have been discharged within the past 30 days should not be given SimplyThick," the agency said.
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Reports link erectile dysfunction drugs to hearing loss
May 20, 2011
The UK's Telegraph (5/19, Bloxham) reported, "Viagra (sildenafil) and similar impotence drugs have been linked to hundreds of cases of sudden hearing loss around the world, including some in the" United Kingdom. "Forty-seven suspected cases of sensorineural hearing loss – a rapid loss of hearing in one or both ears – were linked to Viagra and related" medications Cialis (tadalafil) and Levitra (vardenafil). "The researchers are not sure how Viagra might affect hearing, but it may be that the chain of chemical reactions it triggers have knock-on effects in the inner ear."
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Consumer group petitions FDA to remove higher-dose donepezil from the US market
May 20, 2011
Bloomberg News (5/18, Edney) reported that on May 18, the consumer group "Public Citizen of Washington petitioned the Food and Drug Administration today to remove the 23 milligram dose of Aricept [donepezil, sold by Pfizer, Inc. and Eisai Co.] to treat moderate to severe Alzheimer's from the US market." The group maintains that "higher doses" of the medicine "endanger patients and don't enhance the treatment's effectiveness." According to the US National Institutes of Health, "as many as 5.1 million Americans may have Alzheimer's, the most common form of dementia in older people." The Los Angeles Times (5/18, Maugh) "Booster Shots" reported, "Aricept has been approved by the FDA in dosages of 5 to 10 milligrams for patients with mild to moderate cases of Alzheimer's and in a dose of 10 to 23 milligrams for more severe cases." However, "the petition asks the FDA to ban the 23- mg version of the drug and to warn patients and physicians against taking two 10-mg. pills per day if the higher dosage is removed from the market." The petition explained that "clinical trials of Aricept submitted to the FDA for approval show no significant benefit from the 23-mg version compared to the 10-mg version." The CNN (5/18, Park) "The Chart" blog reported, "The group says that the drug in higher dose compared with the 10-milligrams could pose increased adverse effects, such as slowed pulse rate, nausea, vomiting, diarrhea, urinary incontinence, fatigue, dizziness and agitation." Vomiting can be particularly problematic for Alzheimer's patients, "because it can lead to other problems such as pneumonia, massive gastrointestinal bleeding, esophageal rupture and even death, the group said."
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Congress urged to amend law to preserve consumers' ability to bring class-action lawsuits
May 17, 2011
A Los Angeles Times (5/17) editorial urges Congress to amend the Federal Arbitration Act to authorize states to "declare some arbitration agreements unconscionable." The Times says the US Supreme Court narrowly interpreted the act in refusing class-action status to Vincent and Liza Concepcion's small-claims grievance against AT&T. The Federal Arbitration Act permits state law to trump the enforcement of arbitration agreements, but the justices determined the "exception didn't apply ... because breaking their contract with AT&T would frustrate the purpose of the arbitration act." The Time says the ruling "has made it harder for groups of consumers or employees to band together to seek damages from corporations."
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Feds to seek $1 billion from J&J in off-label marketing probe, unnamed sources say
May 13, 2011
The Wall Street Journal (5/13, Rockoff, Lublin, Subscription Publication) reports that according to unnamed sources who are familiar with the issue, federal prosecutors are planning to solicit $1 billion to settle an investigation of a Johnson & Johnson unit's marketing practices. According to Securities and Exchange Commission filings, for the past six-years, the government has conducting a probe into whether J&J's Janssen Pharmaceutica unit promoted the antipsychotic Risperdal (risperidone) for unapproved, off- label uses. When asked about the possible settlement, according to the Journal, J&J spokespeople said it was inappropriate to speculate. However, the sources say J&J officials were shocked at the sum. Prosecutors apparently used a 2009 settlement in which Eli Lilly paid $1.4 billion to resolve similar allegations regarding its antipsychotic Zyprexa (olanzapine) as a benchmark. Reuters (5/13, Pierson) notes that in its latest SEC filing May 9, J&J noted that to avoid facing civil and criminal proceedings, the company has reserved an unspecified amount of money for a potential settlement.
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Nearly one in seven elderly nursing home residents being given atypical antipsychotics, audit shows
May 12, 2011
The New York Times (5/10, Subscription Publication) "The New Old Age" blog reported that "nearly one in seven elderly nursing home residents, almost all of them with dementia, are given powerful atypical antipsychotic drugs, even though the medicines increase the risk of death and are not approved for such treatments, a government audit found." Notably, "in response to the audit, the Centers for Medicare and Medicaid Services said that some of the inappropriate use of antipsychotics in elderly nursing home patients is a result of drug makers' paying kickbacks to nursing homes to increase prescriptions for the medicines." The Huffington Post (5/10, Baram) "The Watchdog" blog reported that in a statement, Health and Human Services Inspector General Daniel R. Levinson "noted the complicity of drug companies in this dangerous practice." Levinson wrote, "Despite the fact that it is potentially lethal to prescribe antipsychotics to patients with dementia, there's ample evidence that some drug companies aggressively marketed their products towards such populations, putting profits before safety.... The report didn't explore this issue, but a series of lawsuits and settlements that DHHS helped bring about suggest that many pharmaceutical companies have improperly promoted these drugs to doctors and nursing homes for many years."
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Sebelius, hospital CEO tout benefits of patient safety initiative
May 6, 2011
HHS Secretary Katheleen Sebelius and Charles J. Barnett, president/CEO of Seton Family of Hospitals, write in an op-ed for the Austin American Statesman (5/6), "There is no doubt that America has the world's most skilled doctors and nurses and the finest hospitals," yet a new "study found that nearly one out of three hospital patients is harmed by the care they receive." As a result, "the Obama administration has joined with the Seton Family and more than 1,200 other hospitals nationwide, along with hundreds of employers, health insurers, provider organizations, and patient advocates, to launch the Partnership for Patients, an unprecedented alliance that will promote innovations to improve hospital care and reduce wasteful spending." This partnership aims to "reduce preventable injuries in hospitals by 40 percent. And cut readmissions by 20 percent, targeting the return trips to the hospital that should never have occurred." Sebelius notes growing number of hospitals joining patient safety initiative. Modern Healthcare (5/5, Daly, Subscription Publication) reported, "More than 1,200 hospitals have signed up to participate in HHS's $1 billion infection prevention program in the three weeks since it was launched, HHS Secretary Kathleen Sebelius said late Wednesday." These "hospitals are among 2,500 total provider applicants for contracts to reduce preventable harm through the Partnership for Patient safety initiative, which was unveiled April 12 and funded through the Patient Protection and Affordable Care Act." Sebelius said that "what really sets this partnership apart from previous efforts is how eager they were to join."
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GOP lawmakers withdraw from plan to overhaul Medicare
May 6, 2011
A story noting that GOP lawmakers were retreating from the House plan to overhaul Medicare was widely covered by print media, while network television stations instead focused on President Obama's visit to ground zero. Most sources suggested that this shift was a plus for Democrats, while the GOP was left somewhat confused about the party leadership's plans to address Medicare's impact on the deficit. The AP (5/6, Taylor, Alonso-Zaldivar) reports, "The GOP plan to replace Medicare with vouchers will have to wait, party leaders acknowledged Thursday as lawmakers and the White House bowed to political realities in pursuing a deal to allow more government borrowing in exchange for big spending cuts. Both sides hinted at movement and Vice President Joe Biden reported progress from an initial negotiating session." The New York Times (5/6, A1, Hulse, Calmes, Subscription Publication) reports on its front page that although "top Republicans insisted that they remained committed to the Medicare initiative, which had become the target of intense attacks by Democrats and liberal groups in recent weeks, the lawmaker who would have to turn the proposal into legislation said he had no plans to do so any time soon." Dave Camp (R-MI) "said that while he still supports the party's Medicare approach, opposition from Democrats made it pointless to proceed." The Wall Street Journal (5/6, Hook, Lee, Subscription Publication) quotes Camp as saying, "Frankly, I'm not interested in talking about whether the House is going to pass a bill that the Senate shows no interest in. ... I'm not interested in laying down more markers." House Speaker John Boehner (R-OH) agreed with Camp's comments, and pointed out that they represented a "recognition of the political reality that we face." The Los Angeles Times (5/6, Mascaro, Parsons) reports, "In lieu of such an ambitious plan, Republicans are pressing for a series of steep but less dramatic spending cuts as their top deficit-reduction strategy." Democrats and Republicans "also talked of making a commitment to long-term budget cuts that would be enforced by so-called trigger mechanisms that could automatically impose deficit reductions if Congress failed to act in years to come." But, later on, Rep. Eric Cantor (R-VA), "the majority leader, who represented House Republicans at the meeting with Biden," said, "I have not taken Medicare off the table, but the president has. ... The reality is this president has excoriated our budget plan and the Medicare proposal." Politico (5/6, Rogers) reports, "The House Republican confusion over the party's Medicare stance Thursday underscores two worries for the GOP -- an often insecure, rivalrous leadership and a very bright Budget Committee chairman given to jumping ahead of his troops." Similarly, CNN (5/6, Bash, Walsh) reports, "Top House Republicans appeared divided Thursday on whether to keep pushing a controversial plan to overhaul Medicare -- creating what some GOP aides admit is a confused message on an already politically charged topic." In fact, "a senior House GOP source told CNN the story caught other House Republican leaders off guard, since it appeared Cantor was taking the GOP Medicare proposal off the table in negotiations before even stepping into the room." The GOP source stated, "It makes it look like we're not going to hold the line, and makes it look like we're going to cave."
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Databases created to track artificial hip, knee success
May 4, 2011
Bloomberg News (5/3, Farrell) reported, "Databases created by two doctors' groups are now tracking the success rates of artificial hips and knees in the US following a Johnson & Johnson (JNJ) unit's decision last year to recall a hip implant used on 93,000 patients." The American Joint Replacement Registry, "which is funded by orthopedists, prosthetic manufacturers, insurance companies and hospitals, began collecting data from 16 hospitals in December as part of a pilot program, said its chairman, David Lewallen, a professor of orthopedic surgery at the Mayo Clinic in Rochester, Minnesota." The other "registry, funded with a $12 million grant from the Agency for Health Care Research and Quality, a division of the US Department of Health Care and Human Services, is being run by the University of Massachusetts Medical School, according to the registry website."
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Robo-signing controversy delays ripple through foreclosure system
May 4, 2011
The Wall Street Journal (5/4, Timiraos, Subscription Publication) reports the controversy over law firms that acted as foreclosure mills has spread delays through the legal system. After banks dropped some law firms for "robo-signing" mortgage documents, they were left scrambling for replacement attorneys in states that process mortgages through the legal system. Consequently, the banks' foreclosure cases have faced delays, and in some cases, they have had to re-file the cases. LATimes backs California Senate bill to block foreclosure while banks offer modifications. The Los Angeles Times (5/4) says in an editorial that companies "that service most mortgages are still struggling with the volume of loans going bad, in large part because they are woefully understaffed. An extreme example of the problem is when one arm of a mortgage servicing company forecloses on a home even as another arm is offering to modify the loan in order to rescue the borrower. A state Senate committee is considering a bill to block that from happening, and lawmakers should support it." Massachusetts Supreme Court ponders ownership rights amid foreclosure muddle. Bloomberg News (5/3, Weidlich) reported, "The Massachusetts Supreme Judicial Court heard oral arguments today in the appeal of a lower-court decision that said the buyer of residential property in Haverhill, Massachusetts, never owned it because US Bancorp foreclosed before it got the mortgage." A lower court determined Francis Bevilacqua didn't have any legal standing to challenge the property's original owner "to say whether he had a claim on the property." His lawyers assert in their appeal the judge "confused requirements for the law used to prove one's title to a property with those for the law their client sued under, the so- called try-title statute, through which one party seeks to force another to assert or waive a potential claim on the property." Reuters (5/2, Kerber) reported the justices expressed caution in taking a clear side, noting that favoring banks could legitimize the sell of property with partial paperwork, but noted the "situation where thousands of people have purchased in good faith from banks who have foreclosed on properties." US sues Deutsche Bank over mortgage practices. The New York Times (5/4, Story, Subscription Publication, 950K) reports that the Justice Department "sued Deutsche Bank on Tuesday, accusing it of lying about the quality of home loans it handled under a government program and demanding that the bank repay hundreds of millions of dollars of losses on those loans." The mortgages, which are guaranteed by the Federal Housing Administration, "are expected to cost the government more than $1 billion" and originated from loans issued by MortgageIT, which Deutsche Bank acquired in 2007. The FHA "said it discovered the fraud in 2009. Officials from the Justice Department and the Department of Housing and Urban Development said the lawsuit should serve as a warning to other lenders that are issuing loans using a government guarantee."
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House passes GOP bill to cut funding for health insurance exchanges
May 4, 2011
The AP (5/4, Abrams) reports the House Republican "drive to dismantle the new health care law piece by piece advanced Tuesday with a vote to disrupt the flow of federal dollars for health insurance exchanges, an integral part of the law's goal of expanding insurance coverage." The bill, approved on mainly party lines, 238-183, "is mainly a vehicle for Republicans to restate their case against the health care law enacted last year, since the Democratic-led Senate is likely to ignore it and the White House issued a veto threat in the event it passed." The House "is also expected to vote Wednesday on another bill to block funding for a part of the law that offers grants for school-based health center construction." The Hill "Floor Action Blog" (5/4, Kasperowicz) reports, "Republicans spent much of Tuesday on the floor arguing that the bill would repeal what amounts to an unlimited 'slush fund' that the Department of Health and Human Services (HHS) can give to states. The program was established under last year's healthcare law, but does not does not limit HHS to a specific spending level." GOP lawmakers also "noted that HHS Secretary Kathleen Sebelius told members that she believes she has unlimited funds and does not have to seek additional permission to spend more, which they said means spending could exceed the $14 billion estimated by the Congressional Budget Office over the next 10 years." The National Journal (5/4, McCarthy, Subscription Publication) also reports, "The legislation from Energy and Commerce Chairman Fred Upton, R-Mich., would stop Health and Human Services Secretary Kathleen Sebelius from giving states unlimited funds until 2015 to establish insurance exchanges. The agency has already given $49 million to 48 states and the District of Columbia." The Hill (5/4, Baker) reports in its "Healthwatch" blog, "Rep. Frank Pallone (D- N.J.) said de-funding the exchange grants would reduce states' ability to create exchanges tailored to their own needs." But, "Rep. Michael Burgess (R-Texas) argued that even if states receive planning grants and authorize their own exchanges, they don't truly have flexibility over how to structure the new insurance marketplaces. The reform law sets criteria that every exchange, state-run or otherwise, must meet." CQ (5/4, Attias, Subscription Publication) also covers the story. Politico (5/4, Nather) reports the GOP bills "are getting smaller and narrower -- going after shrinking slices of President Barack Obama's health care law, rather than the whole thing." The votes "come after the House has failed in two efforts to block the entire law -- the repeal bill the House passed in January, later blocked in the Senate, and the effort to defund the whole law that met the same fate after it was stripped out of the stopgap spending bill to fund the government for the rest of the year." Still, Republican lawmakers "and GOP strategists say the House has to keep taking the votes -- even if they're narrow and temporarily overshadowed -- so Republicans can keep building the case to their base that they've tried everything to get rid of the health care law." GOP plans to continue "attacks" against healthcare law. The Hill (5/4, Kasperowicz) "Floor Action Blog" reports, "Rep. Marsha Blackburn (R-Tenn.) on Tuesday warned her Democratic colleagues that House Republicans will continue to attack last year's healthcare law until all of it is repealed." GOP lawmakers "also continued to focus on the federal funding for exchanges, which Health and Human Services Secretary Kathleen Sebelius has said is an unlimited fund she can use. Several Republicans bristled at the idea of giving HHS a blank check to fund state programs."
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Studies find guidelines on mammograms can lead to more severe breast cancer
May 3, 2011
Bloomberg News (5/3, Wechsler) reports three radiologist-led studies have found that "women under 50 who follow the advice of a US panel to forgo annual mammograms are risking more severe forms of breast cancer because of it." Failure to receive "regular breast screenings left women more likely to discover cancer at an advanced stage, retrospective research at hospitals in Ohio and Missouri found. The delay resulted in larger tumors and a worse prognosis once the cancer was uncovered, the data found." CNN (5/3, Park) reports on its website that the studies, which "do not appear in peer-reviewed journals," are to "be presented at the American Roentgen Ray Society annual meeting." They "suggest that fewer physicians are recommending annual mammograms for women in their 40s, fewer patients in that age group are getting screened and that tumors found through routine mammography are more likely to be detected in early stages of cancer. The studies examined the impact of the controversial guidelines issued by the US Preventive Services Task Force, a federal advisory board." Health Imaging (5/3, Fratt) reports, "Prior to the 2009 guidelines, for patients aged 40 to 49, 56 percent of physicians recommended screening mammography, 33 percent recommended biannual screening and 11 percent advised against screening. After the guidelines were revised, 20 percent recommended annual screening, 18 percent recommended biannual screening and 8 percent advised against screening." Health Imaging (5/3) reports separately that Paul Dale, MD, chief of surgical oncology at Ellis Fischel Cancer Center at the University of Missouri School of Medicine, said research "found that 20 percent of women diagnosed with breast cancer in our institution are under age 50, and almost half of their tumors were detected through mammography. Given recent advances in targeted treatment of early stage cancer, under these new guidelines, younger breast cancer patients not undergoing screening and early detection may miss out on important therapy that could significantly impact their survival," Dale added.
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Bristol-Myers recalling one lot of warfarin
May 3, 2011
The AP (5/3) reports, "Bristol-Myers Squibb Co. said Monday it is recalling one production lot of its blood thinner Coumadin [warfarin] after finding an oversize tablet." The AP adds, "an excessive dose of Coumadin, or warfarin, could create an increased risk of bleeding." The company "said it has notified the Food and Drug Administration about the recall." MedPage Today (5/2, Neale) reported that "the recall applies to Coumadin Crystalline 5 mg tablets -- lot number 9H49374A -- in 1,000 count bottles, which are distributed to pharmacies for dispensing to customers in prescription quantities."
Reported by the American Association for Justice
FDA to look at how pharmaceutical companies websites' influence consumers
May 2, 2011
Bloomberg News (4/28, Peterson) reports, "Consumer reactions to prescription- drug websites will be assessed by" the Food and Drug Administration "researching how to apply decades-old advertising rules to social media." The FDA "proposed three studies in which participants would answer questions after viewing various versions of a website touting a fictitious drug, according to a notice to be published" today in the Federal Register. The agency said that "the proposed web-advertising studies are 'relevant to current policy questions and debate and will complement qualitative research we plan to conduct on issues surrounding social media.'"
Reported by the American Association for Justice
Supreme Court denies request for expedited review of health law
April 26, 2011
The Supreme Court's decision not to grant fast review to a legal challenge of the healthcare reform law generated extensive print coverage but no mention on network TV, where news of the royal wedding and severe weather dominated the broadcasts. Much of the coverage cast the decision as favoring supporters of the law. Most noted that the court rarely granted fast review, and that Justice Kagan's participation in the decision probably meant a tougher battle for opponents seeking to overturn the health care law. USA Today (4/26, Biskupic), for example, reports, "The Supreme Court's rejection Monday of a request from Virginia officials to hear the constitutionality of the federal health-care law ensures that the legal battle will play out first in lower appeals courts." The Wall Street Journal (4/26, Kendall, Subscription Publication, 2.02M) reports that all nine justices participated in the decision, and the ruling came with no comment, reasoning, recorded vote, or public dissent. Some Republicans have questioned whether Justice Elena Kagan should participate, pointing to her previous post as Solicitor General. Some Democrats, meanwhile, have called for the recusal of Justice Clarence Thomas, citing the outspoken stance of his wife, Virginia Thomas, who has been an avid public opponent of the health reform law. The Huffington Post (4/26, Stein) concludes, "With Kagan apparently set to vote in the Supreme Court's ultimate decision on the Affordable Care Act (and the case is destined to eventually end there) the chances that the law, or part of it, will be ruled unconstitutional are diminished." Meanwhile, the New York Times (4/26, A18, Liptak, Subscription Publication) notes that Kagan has maintained "that she had had almost nothing to do with the administration's plans to defend the health care law against legal challenges. .. Documents released last month under the Freedom of Information Act to CNS News, a conservative Web site, appear to confirm that she took pains to avoid involvement in meetings concerning challenges to the health case law." Politico (4/26, Haberkorn) reports, "The move means the case will proceed through the 4th Circuit Court of Appeals. Oral arguments are scheduled for May 10." The AP (4/26, Sherman), meanwhile, says that "the case still could reach the high court in time for a decision by early summer 2012." The Washington Times (4/26, Cunningham) reports that Virginia Attorney General Ken Cuccinelli "asked the justices in February to redirect it out of federal appeals court and resolve questions about its constitutionality more quickly."
The Washington Post (4/26, Barnes) notes that Cuccinelli had told the court that "it should short-circuit the usual appeals process because of a 'palpable consensus in this country that the question of PPACA's constitutionality must be and will be decided in this court.'" In response to the decision, "Cuccinelli said it was 'disappointing but not surprising,' given the rarity of such expedited cases." More health law challenges pending. The Christian Science Monitor (4/26, Richey) reports, "To date, federal district judges have issued five decisions on the constitutionality of the health-care law's individual mandate -- the requirement that each citizen must purchase a government-approved level of health insurance or pay a penalty. ... In addition to the Fourth Circuit in Richmond, appeals are pending at the Eleventh Circuit in Atlanta, the Sixth Circuit in Cincinnati, and the federal appeals court in Washington, DC. ... Depending on how quickly the appeals courts announce their decisions, one or more of these cases could be appealed to the Supreme Court as early as next term."
Reported by the American Association for Justice
Award in Risperdal lawsuit against Johnson & Johnson unit could reach billions
April 26, 2011
The AP (4/26, Kinnard) reports, "It's now up to a Spartanburg County judge to decide how much a Johnson & Johnson subsidiary should pay South Carolina for deceptive marketing of" schizophrenia drug Risperdal (risperidone). A jury ruling last month determined Janssen Pharmaceutica, Inc. "violated the South Carolina Unfair Trade Practices Act by sending misleading letters to about 7,200 doctors in South Carolina downplaying the links between diabetes and" Risperdal. "In a court exhibit, attorneys for the state argued that they see the number of violations as potentially including every single prescription, sample box or 'Dear Doctor' letter written since the mid-1990s -- numbers that reach into the millions. Considering the 620,000 Risperdal prescriptions written for people on Medicaid and the state health plan alone, that could mean more than $3.1 billion."
Reported by the American Association for Justice
Medical Errors May be 10 Times More Likely Than Originally Thought
April 22, 2011
Several news sources including Bloomberg.com and Fiercehealthcare.com have reported on a new study published in Health Affairs that reveals U.S. hospitals and regulators fail to record 90% of patient injuries, infections and other safety concerns. The study, conducted by researchers at the University of Utah and the Institute for Healthcare Improvement, reviewed 795 patient records where four adverse events were voluntarily (and anonymously) reported by providers. In their review of the patient records, the researchers found 354 instances of “adverse events” had occurred. When using guidelines established by the Agency for Healthcare Research and Quality, only found 35 instances of adverse events were found in the same set of patient records. David Classen, a professor at the University of Utah School of Medicine and co-author of the study concluded that “[a]n incomplete picture of how often patients are harmed undermines public and private efforts to improve the quality of medicine in the U.S.” The researchers did not try to establish whether the adverse events themselves were preventable. In a similar study published in the New England Journal of Medicine in November, a six-year study of hospital admissions in North Carolina found that almost one in five patients were injured by their care. The most common and expensive injuries were pressure sores and post-surgical infections.
Source: Fierce Healthcare and Bloomberg News
Judge throws out New Jersey challenge to healthcare law
April 22, 2011
Bloomberg News (4/22, Voreacos) reports, "A federal judge in New Jersey dismissed a lawsuit challenging the constitutionality of the Obama administration's health- care law." US District Judge Freda Wolfson "ruled that two men who sued without a lawyer, Nicholas Purpura and Donald R. Laster Jr., lack legal standing to challenge the 2010 Patient Protection and Affordable Care Act." The plaintiffs "claimed the law's requirement that almost every American have some form of medical insurance starting in 2014 was unconstitutional." The case is "Purpura v. Sebelius, 10-cv-4814, US District Court, District of New Jersey (Trenton)." The AP (4/22) reports that the "lawsuit also claims the measure was signed into law by a person not eligible to be president of the United States, alleging that President Barack Obama was not US-born." Modern Healthcare (4/22, Daly, Subscription Publication) quotes Wolfson as stating in her decision, "It is patently clear to this court that, contrary to what is clearly required to establish standing, plaintiffs have not alleged an injury in fact sufficient to establish standing."
Reported by the American Association for Justice
Health reform initiative to reduce medical errors discussed
April 22, 2011
The Wilmington News Journal (4/22, Ratnayake) reports, "Providing better care is the intent of one initiative under the Affordable Care Act. Known as the Partnership for Patients, the initiative is designed to improve patient safety by forging a bond between hospitals, patient advocacy groups, medical societies and government agencies." Commenting on the initiative, HHS Secretary Kathleen Sebelius said, "The challenge is to figure out how to make these models spread and accelerate this improvement." She added that American physicians "and nurses are already working as hard as they can...and telling them to solve this problem on their own would be unfair and unproductive."
Reported by the American Association for Justice
Calcium supplements may increase risk for heart attacks and strokes in women
April 21, 2011
The Washington Post (4/19, Stein) "The Checkup" blog reported that "an analysis of data collected about more than 16,000 women who participated in the landmark Women's Health Initiative found that those who started taking calcium as part of the study were at increased risk for heart attacks and strokes." The research, "published in...BMJ, found that the women who were not taking calcium when the study started but began taking it when they got into the research project were at between 13 and 22 percent increased risk. The risk occurred regardless of whether the women were taking calcium alone or combined with vitamin D, the researchers found." HealthDay (4/19, Gardner) reported that "the case against calcium became stronger when researchers added in data from 13 other, unpublished trials involving almost 30,000 women. Now the increased risk for heart attack was 25 to 30 percent and, for a stroke, 15 to 20 percent." MedPage Today (4/19, Kaiser) reported that "the authors suspect that the abrupt change in blood calcium levels after taking a supplement causes the adverse effect, rather than it being related to the total amount of calcium consumed."
Reported by the American Association for Justice
ONDCP says Congress should mandate painkiller safety training
April 21, 2011
USA Today (4/20, Ledger) reports, "To halt prescription drug abuse, the nation's fast-growing drug problem, Congress must require special training for doctors and other health care workers before they are allowed to prescribe powerful drugs such as OxyContin," ONDCP Director Gil Kerlikowske said Tuesday. The Wall Street Journal (4/20, Gleason) reports the Food and Drug Administration said Tuesday that it will require pharmaceutical companies to produce new educational tools about their opioid painkillers in an effort to reduce prescription drug abuse. Department of Health and Human Services Assistant Secretary Howard Koh said at a briefing, "This growing public-health crisis is suffocating our society." USA Today (4/20, Ledger) reports, "American Medical Association President Cecil Wilson said his organization supports the intent of the drug abuse prevention plan but is concerned 'that a key element of this strategy that relies on industry to develop educational materials and initiatives to train prescribers could in the future become a mandatory part of the DEA registration process for prescribing controlled substances.'" Bloomberg News (4/19, Larkin) reported, "Pfizer Inc. (PFE), Johnson & Johnson (JNJ) and Endo Pharmaceuticals Holdings Inc. (ENDP) will have to train doctors before they can give patients extended-release painkillers under a US plan aimed at reducing prescription drug abuse." The Food and Drug Administration said on Tuesday that "sixteen companies that make 25 pain patches and pills must create a program to teach medical professionals when these drugs should be used to combat pain and how to recognize signs that the treatments are being misused." HealthDay (4/19, Gardner) reported, "The new Risk Evaluation and Mitigation Strategy (REMS) is part of a larger multi-agency initiative announced Tuesday by the White House to reduce overall prescription drug abuse in the" US. "'This new REMS will provide tools to doctors and other prescribers for appropriate pain management to reduce risks and at the same time preserve access for patients and appropriate management of pain for those suffering from moderate to severe pain,' said Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the" FDA. "For now, the initiative will be limited to extended-release and long-acting products, which, Woodcock said, 'have a much greater risk than immediate-release because they contain more medicine.'" Modern Healthcare (4/20, Daly, Subscription Publication) reports, "President Barack Obama's administration also will push for enactment of as-yet- unintroduced legislation to require physician participation in opioid prescribing training. And Gil Kerlikowske, director of National Drug Control Policy, said he is confident that Congress would enact such a measure promptly based on the previous passage of other recent measures focused in part on opioid-abuse control." But, "if Congress does not enact a law requiring mandatory physician participation in such training, the FDA could aim to tighten control on opioid prescribing through restricted formularies." The Hill (4/19, Pecquet) "Healthwatch" blog reported, "As a first step, the FDA sent letters to opioid manufacturers on Tuesday requiring that they provide a plan for training prescribers and educating patients about the safe use, storage and disposal of opioids. They have 120 days to respond, setting in place a regulatory process that officials hope to have in place within 12 months. 'We have determined that a Medication Guide and a Communication Plan are not sufficient to mitigate the serious risks,' the letters state. 'Your (strategy) must include tools to manage these risks'" On its website, CNN (4/20, Young) reports, "'Unintentional drug overdose is a growing epidemic in the US and is now the leading cause of injury death in 17 states,' said Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention. 'There are effective and emerging strategies out there to address this problem. Support for this action plan will help us implement those strategies which will go a long way to save lives and reduce the tremendous burden this problem has on our healthcare system and our society.'"
Reported by the American Association for Justice
Sebelius highlights effort to reduce medical errors
April 20, 2011
CNN Newsroom Early (4/19, Malveaux) interviewed Health and Human Services Secretary Kathleen Sebelius. Asked about the government's initiatives to limit medical errors, Sebelius said, "Just last week, we launched a partnership for patients" that is "an effort with healthcare providers, hospital administrator, but employers and union members and business owners and government officials to say we have some of the best healthcare in the world. .. We're saying in three years, we can save 60,000 lives, prevent about three million Americans from either being injured or returning unnecessarily to the hospital, and really improve care for everyone. And we've got the tools now in the Affordable Care Act to do that."
Reported by the American Association for Justice
FDA adds website feature to give consumers better way to track recalled foods
April 19, 2011
The "Healthwatch" blog at The Hill (4/18, Pecquet) reported that the FDA changed its website so consumers can keep track of recalled foods, a measure required by the Food Safety Modernization Act, which said the FDA should create "a consumer-friendly recall search engine." The act also "gives the FDA power to recall tainted food, quarantine geographical areas and access food producers' records." The website change went live Monday.
Reported by the American Association for Justice
House votes to cut funding for health reform prevention fund
April 18, 2011
CQ (4/18, Symes, Subscription Publication) reports, "With some calling the mandate a 'slush fund,' House Republicans voted last week to strip funding for a health care overhaul provision that provides support for programs aimed at preventing tobacco use, obesity, heart disease, strokes and cancer." The measure would "repeal the section that establishes and allocates funding to the Prevention and Public Health Fund." Yet, it is "unlikely to become law. President Obama has vowed to veto it, and the Senate has rejected several attempts to roll back the overhaul." Healthcare law suffered several setbacks last week. Modern Healthcare (4/15, Zigmond, Daly, Subscription Publication) reported, "It was a tough week in Washington for the Affordable Care Act. First, House members voted April 13 to repeal the law's prevention and public health fund, which would grant authority to the HHS secretary to administer $17.75 billion in funding from 2012 to 2021." Then, President Obama "signed into law legislation that repeals the Affordable Care Act's 1099 reporting provision, which would have required businesses -- starting in 2012 -- to report all transactions worth $600 or more to the Internal Revenue Service."
Reported by the American Association for Justice
CPSC issues required safety guidelines for toddler beds
April 18, 2011
The AP (4/15) reported the Consumer Product Safety Commission issued "mandatory standards for various infant and toddler products" under Congressional instruction. The "new standard requires that the upper edge of the guardrail be at least 5 inches above the toddler bed's mattress, that testing of the bed's slats be consistent with testing for slats in cribs and that separate warning labels to address entrapment and strangulation hazards appear on the toddler beds." Convertible crib-to-toddler beds must also meet the regulations.
Reported by the American Association for Justice
Bill to protect Americans from adulterated imports garners bipartisan support
April 14, 2011
CQ HealthBeat (4/14, Adams, Subscription Publication) reports, "House Democrats and Republicans, in a rare glimpse of bipartisan interest, signaled in a hearing" of the House Energy and Commerce Subcommittee on Oversight and Investigations expressed "a willingness to give the Food and Drug Administration the authority to destroy imported pharmaceuticals that the agency believes to be fake or contaminated." Democrats on the committed "on Tuesday introduced import safety legislation (HR 1483) that, among other things, would beef up laws aimed at protecting Americans from adulterated or contaminated prescription drugs from" abroad. It would "make much more sense," FDA Commissioner Margaret A. Hamburg said, if the agency "simply had full authority to destroy questionable drugs instead of returning them to the sender, who may try again to send harmful products into the US."
Reported by the American Association for Justice
FDA website provides information on food recalls
April 14, 2011
The Louisville Courier-Journal (4/12, Carter) "Health Bytes" blog reported, "The US Food and Drug Administration is now providing search results about food recalls in a more consumer-friendly format thanks to the Food Safety Modernization Act that President Obama signed in January." Search results "appear in a table format. To conduct a search or view a table of recent recalls of food and some other types of products, such as drugs and dietary supplements, go here."
Reported by the American Association for Justice
GAO: FDA device approval process endangers patients
April 14, 2011
The AP (4/14, Perrone) reports, "Government investigators say the Food and Drug Administration is putting patients at risk by approving sensitive medical devices such as hip joints and heart defibrillators under the same streamlined system intended for power wheelchairs, stitches and catheters." Notably, the "Government Accountability Office told Congress Wednesday that the approvals remain a serious issue for the government -- more than two years after the watchdog agency first cited the problem to the FDA." In response, Dr. William Maisel, deputy director for science in FDA's device center, said that the agency "will reclassify the 26 types of high-risk devices cited by GAO before the end of 2012." The Minneapolis Star Tribune (4/14, Spencer, Moore) reports that Marcia Crosse, the GAO's director of health care, "testified at a Senate hearing that explored the need for legal or regulatory changes to the ways medical devices come to market. Many devices avoid clinical trials and win approval on the basis that they are 'substantially similar' to devices already on the market." In addition, the "Senate Special Committee on Aging...heard from a Colorado woman whose artificial hip was recalled and had to be removed from her body four years after its implantation because it was shedding toxins into her bloodstream." The FDA did not require any "human testing of the all- metal joint before it went on the market." CQ (4/14, Adams, Subscription Publication) says that the GAO findings were based on an "analysis of 3,510 voluntary recalls from 2005 through 2009." The results were "discussed as part of a debate over whether the agency should update the so-called 510(k) process, which is the main procedure for approving medical devices. The process was intended to be an approval route for products similar to those already on the market; unlike another rarely -used and more stringent review for new products, known as the premarket approval (PMA) process, the 510(k) procedure does not require manufacturers to test devices in people before selling them in the United States."
Reported by the American Association for Justice
HHS initiative aims to reduce medical errors, costs
April 13, 2011
Print media sources widely covered an announcement Tuesday that the Obama Administration was partnering with hospitals, insurers and other groups in order to reduce medical errors. Most sources considered the move a positive for the Administration. The Los Angeles Times (4/13, Levey) reports, "The Obama administration announced a broad new initiative Tuesday to reduce medical errors, partnering with private insurers, business leaders, hospitals and patient advocates to tackle a problem that kills thousands of Americans every year." This "campaign, funded by the healthcare overhaul the president signed last year, aims to cut by 40% over the next three years the number of harmful preventable conditions such as infections that patients acquire in the hospital." HHS Secretary Kathleen Sebelius made the announcement about the Partnership for Patients initiative, and CMS Administrator Donald Berwick noted that the initiative has "big goals." The AP (4/13) reports, "Sebelius said the new national Partnership for Patients will help other hospitals adopt those proven safety strategies." The program "is funded by $1 billion from the new healthcare law, but has the potential to save Medicare up to $10 billion in that same time." The New York Times (4/13, Abelson, Subscription Publication) "Prescriptions" blog quotes Sebelius as saying, "Americans go the hospital to get well, but millions of patients are injured because of preventable complications and accidents. ... Working closely with hospitals, doctors, nurses, patients, families and employers, we will support efforts to help keep patients safe, improve care, and reduce costs. Working together, we can help eliminate preventable harm to patients." According to the CNN (4/13) "The Chart" blog, the initiative "will save 60,000 lives over the next three years by reducing millions of preventable hospital-related complications and injuries. Sebelius says the new partnership will also save about $35 billion in healthcare costs including $10 billion in Medicare savings." Meanwhile, American Medical Association president Cecil Wilson, MD, said that the group's "physicians will be encouraged to do everything they can to reduce adverse events and hospital readmissions." Wilson added, "We know that if we ensure that a patient's primary care physician receives their discharge papers within 24 hours of their release from the hospital, the likelihood of hospital readmission will be reduced." The Hill (4/13, Pecquet) reports in its "Healthwatch" blog that HHS aims to accomplish the initiative's goals "by disseminating best practices that have already allowed the nation's best hospital systems to cut preventable errors significantly." Berwick noted, "Blame and accusation are not the answers; teamwork, improvement are the answers." The AMA's Wilson is also quoted as saying, "We all need to do everything we can to avoid preventable patient illness and injuries while also working to ensure that patients are able to heal without complications." Reuters (4/13, Smith) reports that another goal of the initiative is to cut hospital readmissions by at least 20 percent. Sebelius noted that 500 hospitals are already part of the effort. CQ (4/13, Reichard, Subscription Publication) reports, "Because the program is voluntary, making good on the projections is initially going to require a disciplined effort by hospital and other healthcare CEOs to devote time and resources to the project -- in addition to their efforts to comply with the many requirements of the healthcare law." Berwick explained that "the changes needed in healthcare delivery to meet the goals of the project will help hospitals qualify in a few years for incentive payments under the health law to improve patient safety." The PBS NewsHour (4/13, Bowser) "The Rundown" blog reports, "The partnership will begin by asking hospitals to focus on nine types of medical mistakes where there is potential for dramatic reductions in harm. These include pressure ulcers, drug reactions, childbirth complications and surgical site infections." Notably, Berwick will "oversee the new partnership." He stated, "Through strong partnerships at national, regional, state and local levels ... we are supporting the hospital community to significantly reduce harm to patients." But, FOX News (4/13, Barrett) "America's Election HQ" blog says that "the plan's parameters could be in jeopardy going forward. House Republicans have introduced a 2012 budget that would, in essence, end Medicare, and earlier this year, voted to repeal the Affordable Care Act." In addition, "some critics say the partnership initiative further proves the Affordable Care Act was bad medicine."
Reported by the American Association for Justice
Concern growing over synthetic drugs' accessibility
April 12, 2011
On its website, CBS News (4/8, Koeppen) reported that there is "growing concern over the use of synthetic substances because they're easy to find and, in some cases, perfectly legal to buy." In fact, "an 'Early Show' staffer...had no problem scoring fake pot and bath salts," and "they're having powerful effects on users." To date, "nine deaths have reportedly been linked to the use of synthetic drugs."
Reported by the American Assocaition for Justice
Patients taking high daily prescription painkiller doses may be at increased risk of death
April 7, 2011
HealthDay (4/5, Preidt) reported, "Patients who are prescribed higher doses of opioid painkiller drugs (such as Oxycontin or Vicodin) are at increased risk of death from overdose than those given lower doses," according to a study in the April 6 issue of the Journal of the American Medical Association. The researchers examined Veterans Affairs data on "750 accidental opioid overdose deaths that occurred from 2004 to 2008 and a random sample of almost 155,000 patients who received opioids to treat pain in 2004 or 2005." According to MedPage Today (4/5, Fiore), the risk of overdose death "significantly increased with doses of 100 mg/d or more of morphine (or its equivalent in other opioids), compared with doses below 20 mg/day, for all patient subgroups," including those with: "substance abuse disorders (HR 4.54, 95% CI 1.46 to 8.37); chronic pain (HR 7.18, 95% CI 4.85 to 10.65); acute pain (HR 6.64, 95% CI 3.31 to 13.31); [and] cancer pain (HR 11.99, 95% CI 4.42 to 32.56)."
Reported by the American Association for Justice
CMS unveils data on hospital-acquired conditions
April 7, 2011
CQ HealthBeat (4/7, Reichard, Subscription Publication) reports, "Federal officials announced Wednesday the release of data allowing consumers to learn how often patients in local hospitals acquire infections, develop bed sores or are harmed by gas or air bubbles entering blood vessels." Notably, information "on these and other 'hospital-acquired conditions' will guide consumers in picking hospitals and prod facilities themselves to make improvements, officials said." CMS Administrator Donald M. Berwick stated, "Any potentially preventable complication of care is unacceptable." He added that the agency is "working together with the hospital and consumer community to bring hospital acquired conditions into the forefront," and prevent patients from being harmed. The Hill (4/7, Millman) reports in its "Healthwatch" blog, "Medicare beneficiaries for the first time will have access to data about hospital-acquired condition (HAC) rates." For more than two years, CMS has "banned reimbursements for care resulting from HACs, and the healthcare reform law enacted a year ago requires the same policy to be extended to state Medicaid programs." Study: Hospitals, regulators may record just 10 percent of errors. Bloomberg News (4/7, Young) reports, "Hospitals and US regulators fail to record at least 90 percent of patient injuries, infections and other safety issues," according to a new review, which "uncovered 354 so-called adverse events, such as pressure sores, bloodstream infections and medication errors, at three US teaching hospitals." In fact, "a system designed by the federal Agency for Healthcare Research and Quality identified 35 cases at the same facilities while the hospitals' voluntary reporting programs found four, according to the study," which utilized the Institute for Healthcare Improvement's (IHI) Global Trigger Tool to arrive at these conclusions. Modern Healthcare (4/7, McKinney, Subscription Publication) reports, "The study's authors warned that hospitals using voluntary reporting systems alone to assess patient safety 'may be seriously misjudging actual performance.'" In addition, they "cautioned against reliance on AHRQ's Patient Safety Indicators, which missed most of the events identified by the IHI's tool, they said." Reuters (4/7, Steenhuysen) reports that the research appeared in the journal Health Affairs and were supported by a grant from the Robert Wood Johnson Foundation. Falls, burns, trauma most common patient injuries in Utah hospitals. The Salt Lake Tribune (4/7, May, McCann) reports, "Falls, burns or other types of trauma are the most common injuries that patients experience while staying in Utah hospitals, a problem they appear to experience more often than patients nationally," according to data disclosed by Medicare which report "how often hospitals report serious conditions and complications that developed during a patient's stay." The Tribune points out, "Of the 31 Utah hospitals analyzed, 17 reported a total of 56 falls or injuries caused by trauma."
Reported by the American Association for Justice
Antidepressants associated with accelerated atherosclerosis in middle-aged men
April 5, 2011
Bloomberg News (4/3, Cortez) reported, "Antidepressants may narrow the arteries of middle-aged men, potentially putting them at risk for heart attacks and stroke," according to a study presented at the American College of Cardiology meeting in New Orleans. In "a study involving 513 male twins, with an average age of 55, found those who took medications like Forest Laboratories Inc.'s Lexapro [escitalopram], Eli Lilly & Co.'s....Cymbalta [duloxetine], or Pfizer Inc.'s Zoloft (sertraline) had thicker blood vessel walls." What's more, "the increase, a measure of fatty-plaque buildup linked to atherosclerosis, was seen regardless of what type of antidepressant the men were taking." The Los Angeles Times (4/2, Maugh) reported, "Overall, when the researchers adjusted for age, diabetes, blood pressure and other factors, they found that the intima-media thickness of men taking antidepressants was 37 microns (about 5%) thicker than that of men not taking the" medications. "When the team looked at 59 twin pairs in which one twin was taking the drugs and the second was not, the artery was 41 microns thicker in the twin taking" antidepressants. HealthDay (4/2, Reinberg) reported, "Since each additional year of life is associated with a small increase in intima-media thickness, a brother taking antidepressants is physically four years older than the brother not taking antidepressants," the researchers "contended. They also said that even a small increase in intima-media thickness can increase the risk of a heart attack or stroke by 1.8 percent." In a conversation with HeartWire (4/2, O'Riordan), the study's lead author, Amit Shah, MD, PhD, of the Emery University School of Medicine, "said that increased atherosclerotic burden of the carotid artery is not on the radar of practicing clinicians, including psychiatrists, and that most are instead concerned with sleep, appetite, and sexual side effects as well as weight gain." Therefore, "while these data should not be used to take patients off medications, the clinician needs to assess the benefits and risks on a patient-by-patient basis."
Reported by the American Association for Justice
FDA launches new website on recalled foods
April 5, 2011
The Los Angeles Times (4/5, Zajac) reports the Food and Drug Administration has launched a website that compiles food "recall notices in a searchable table." The FDA "webpage displays information on recalls since 2009 by date, product brand name, product description, the reason for the recall and the firm doing the recalling. It also includes an image of the product label and links to the press release on each recall -- which generally contain additional information." The Portland (ME) Press Herald (4/5) reports, Mike Taylor, FDA deputy commissioner for foods, said in a statement, that recalls "mandatory or otherwise, are serious and we must do everything possible to make it easier for people to know about these recalls so they can take all appropriate steps to protect themselves and their families."
Reported by the American Association for Justice
FDA proposes rules requiring chain restaurants to post calorie counts
April 4, 2011
The AP (4/2, Jalonick) said the Food and Drug Administration on Friday proposed new rules that require chain restaurants "with 20 or more locations, along with bakeries, grocery stores, convenience stores and coffee chains, to clearly post the amount of calories in each item on menus, both in restaurants and drive-through lanes. The new rules will also apply to vending machines where calorie information isn't already visible on the package." But, movie theaters and any businesses who do not primarily sell food would be exempt. FDA deputy commissioner for foods Mike Taylor said, "'We've got a huge obesity problem in this country and its due in part to excess calorie consumption outside the home. Consumers generally when you ask them say they would prefer to have that information." The Los Angeles Times (4/2, Zajac) said the rules represent "the latest attempt to gain ground against the nation's epidemic of obesity." In this connection, FDA deputy commissioner Taylor said: "Nobody thinks that calorie information by itself solves the problem, but it's part of the tool kit. We see this as part of the overall effort to fight obesity." The new rules "would generally apply to businesses that either define themselves as restaurants or devote more than 50% of their floor area to the sale of food." Although the National Restaurant Association endorsed the publication of the proposed rules, it "anticipates many questions." The trade group promised "detailed comments to the FDA to ensure that restaurants are provided adequate time and are able to comply with the regulations effectively, as well as provide information to consumers in the most usable way." The New York Times (4/2, Neuman) explained that a preliminary FDA document on the rules released last summer "would have included movie theaters. But, Mr. Taylor said officials decided to write the rules so that they would apply only to establishments whose primary purpose was to sell food or where at least half the floor space was dedicated to food sales. 'The thinking has absolutely evolved based on comments we've gotten from a number of quarters,' Mr. Taylor said. 'This is a different drawing of the circle of what is covered by this law.'"
Lawmaker targets exemption for movie theaters. The Washington Post (4/2, Layton) noted that the rules would cover a chain kiosk housed inside another business. The Center for Science in the Public Interest "hailed the proposed rules but said that theaters and alcoholic beverages should have been included. 'If a movie theater is going to serve up thousand-calorie tubs of popcorn, 400-calorie drinks and 400- calorie boxes of candy, the least they could do is tell you about it,' said Margo Wootan, nutrition policy director for the group. Rep. DeLauro (D-CT), who authored a separate bill requiring menu labeling, said Friday that she would 'work to ensure that the final rule is strengthened' to include movie theaters and alcoholic beverages." Under the headline, "Calorie Rules Make Diets A Federal Affair," the Wall Street Journal (4/2, Adamy) said exemptions may lead to an uneven application of the rules, since customers will learn the calorie information of a Starbucks Frappuccino but not a beer at the bar.
Reported by the American Association for Justice
More than 50 percent of cardiology guideline-writing physicians report conflicts of interest
March 29, 2011
The Wall Street Journal (3/29, Burton) reports that, according to a newly published paper in the Archives of Internal Medicine, more than 50 percent of physicians with financial ties to drug and device makers who pen cardiology practice guidelines experience conflicts of interest. And, even though such incidents are often reported, researchers at the University of Pennsylvania say the risk of bias is increased, which could adversely affect patient care. Before reaching those conclusions, investigators looked at "the 17 most recent American College of Cardiology/American Heart Association clinical practice guidelines issued through 2008," HealthDay (3/28, Preidt) reported. "Of the 498 people involved in creating those guidelines, 277 (56 percent) reported a conflict of interest (COI)," and the "most common types of conflict of interest were: being a consultant or member of an advisory board, receiving a research grant, being on a speaker's bureau and/or receiving honoraria, and owning stock. Through these types of links, there were 510 commercial companies involved in the 17 guidelines, compared with only 18 non-commercial organizations." In "a joint statement on Monday, the cardiology and heart associations said that they had tightened their conflict-of- interest controls in 2010 to align with recommendations from the Council of Medical Specialty Societies," the New York Times (3/29, B3, Wilson) reports. They "now require that the people leading the group and a majority of members of any guideline-writing group be free of conflicts of interest." Still, "in a related commentary in the journal, Dr. Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic and a former president of the American College of Cardiology, called for banning most of those conflicts rather than just disclosing them." Among "other things, he noted, it 'defies logic' that experts who have acted as speakers for industry or hold stock in a company should be allowed to write guidelines that affect that company," MedPage Today (3/28, Smith) reported. He also pointed out that "such relationships 'have created a dependency that is difficult to terminate, because the leadership of professional societies is reluctant to antagonize their financial benefactors.' How much those financial ties influence the selection of guidelines committee members isn't clear, he added, but the possibility 'certainly raises appropriate concerns."
Reported by the American Association for Justice
FDA asks Triad Group to halt drug making and distribution
March 29, 2011
MSNBC (3/28, Arnold) reported that the Food and Drug Administration has asked Triad Group to voluntarily "stop making and distributing all of its drug products." Shelly Burgess, an FDA official, explained that the request was made after an inspection on Monday. According to MSNBC, the FDA "pointed out contamination concerns at the plant as far back as 2009." Triad "voluntarily recalled its sterile lubricating jelly in December, citing possible contamination" and "recalled all of its alcohol prep pads and swab sticks days before the end of another FDA inspection" and "this month Triad issued a voluntary recall of its iodine prep pads, citing possible contamination from a different organism."
Reported by the American Association for Justice
FDA urges consumers to stop using Soladek vitamin solution
March 29, 2011
The AP (3/29) reports that the Food and Drug Administration "warned consumers Monday to avoid Soladek vitamin solution because it may contain dangerously high levels of vitamins." The FDA "said it has received seven reports of serious health problems among people who used the product, including vomiting, diarrhea, and kidney malfunction." The agency "urged consumers who have Soladek to stop using it immediately and contact their doctor if they are experiencing symptoms."
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Advocacy group finds 55% of physicians with restricted privileges are not disciplined
March 16, 2011
The Orlando Sentinel (3/16, Shrieves) reports that for about the past 20 years, "state medical boards responsible for disciplining doctors have failed to punish more than half of those whose hospitals revoked or restricted their privileges, according to a new report released Tuesday" by the group Public Citizen, a nonprofit consumer advocacy group. "Altogether, the report says, 32 states let more than half of the offending doctors go without any reprimand." In Florida alone, the report "found that 63 percent of the doctors whose hospital privileges were restricted or revoked were not disciplined by the state's Board of Medicine." The Washington Post (3/16, Sun) reports, "Among the most serious violations, which involved 2,071 of the 5,887 physicians who were not disciplined, were doctors who posed an immediate threat to health or safety, were incompetent or negligent, or provided substandard care, the study found." Sidney Wolfe, director of Public Citizen's Health Research Group and overseer of the study, "said he is urging US Health and Human Services Secretary Kathleen Sebelius to have the agency inspector general's office reinstitute investigations of state medical boards." CQ HealthBeat (3/16) reports that the consumer advocacy group is also "notifying the 33 medical boards that have the worst records in disciplining these doctors."
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Justice Department seeks expedited appeal of healthcare law ruling
March 10, 2011
Bloomberg (3/10, Harris) reports that the "US Justice Department is seeking an expedited appeal of a federal judge's ruling striking down President Barack Obama's health-care reform legislation." The federal government is "asking the US Court of Appeals in Atlanta to speed its review of the Jan. 31 decision by US District Judge C. Roger Vinson in Pensacola, Florida." Bloomberg adds that "Vinson found unconstitutional the Patient Protection and Affordable Care Act provision requiring individuals to procure insurance coverage starting in 2014."
The AP (3/10) reports the "Obama administration is asking a federal appeals court in Atlanta to act swiftly on a lawsuit challenging the constitutionality of the government's healthcare overhaul." According to "a seven-page filing, the Justice Department says expedited treatment of the case is warranted because of the far-reaching nature of the decision by a federal judge who declared the entire law unconstitutional." The AP adds that the "government is proposing that it file its first set of court papers on the issues in the case by April 18 and that those challenging the law file theirs by May 18."
Politico (3/10, Haberkorn) reports that the Administration's lawyers said, "Expedition in this case is particularly warranted because of the district court's unprecedented severability ruling, which presents issues that the federal government has not previously addressed in appellate briefs and covers numerous provisions of the Act already in effect."
CNN International (3/10, Mears, Cratty) reports on its website that the "11th Circuit has not indicated whether it would agree to the expedited schedule, and there was no immediate response from lawyers representing Florida and 25 other states that had filed the original lawsuit opposing the law." Notably, the "federal government wants to know whether these provisions can continue while the issue is under appeal, particularly in the 26 states that filed this lawsuit." CNN adds that "Oklahoma and Virginia have filed separate legal challenges that are concurrently working their way through appeals courts in Cincinnati and Richmond."
The Palm Beach (FL) Post (3/10, Singer, Kam) reports that the "Justice Department ignored pleas that it fast-track its appeal directly to the US Supreme Court, instead filing an appeal and request for speedy hearing with the 11th US Circuit Court of Appeals in Atlanta." The Post adds that a "hearing could come as early as midsummer, soon after two other federal appeals are scheduled." Separately, this week the Florida "Senate approved [SJR 2] a proposed constitutional amendment [by a 29-10 vote] allowing Florida to opt out of the federal healthcare law."
The Dayton (OH) Business Journal (3/10) reports that the "suit had the support of 26 states -- including Ohio -- as well as two private citizens and the National Federation of Independent Businesses." The Journal adds, according to a research group, consumers "and small businesses in Ohio will face significantly higher insurance premiums and could see coverage denials and price discrimination if the federal healthcare law is repealed." NYTimes: Vinson correct in allowing health reform implementation to proceed.
The New York Times (3/10) editorializes that a "federal district judge in Florida backed down, as he should have, from his effort to bully the Obama administration into halting implementation of the new healthcare reforms even before the issue of the law's constitutionality is resolved by higher courts." Federal Judge Vinson, "who is handling a lawsuit brought by 26 states, two private citizens and a federation of small businesses, was the only judge to rule that the entire reform law was void and then strongly implied that the administration should immediately stop implementing it." The Times says that Vinson correctly "stayed his own ruling on condition that the administration seek an expedited appellate review of his decision, a step the Justice Department began with court filings on Tuesday." Justice Department infuriates Judge Vinson.
Heartland Institute fellow Maureen Martin writes in the Washington Times (3/10) op-ed section that in "the proceedings prior to January, the Justice Department had acknowledged to Judge Vinson in writing the equivalence of these two remedies and had 'specifically insisted that they would honor' (in Judge Vinson's words) the declaratory judgment as an injunction -- meaning they promised the court they wouldn't enforce the healthcare law." Yet, "mere hours after Judge Vinson's opinion was issued, the Justice Department broke its word and announced that it would ignore the court order and continue to enforce Obamacare." Martin says that these types of actions by the Justice Department has made Judge Vinson and other judges, such as Judge Feldman who is involved with the oil spill moratorium case, "furious."
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Study finds poor communication between EDs, primary-care physicians
March 10, 2011
Scripps (3/10, Bowman) reports that a new study "underscores how haphazard communication between" emergency department (ED) doctors and primary-care physicians "can undermine effective care." The Center for Studying Health System Change "matched 21 pairs" of ED and primary-care physicians "working out of the same hospital." The researchers found patients' regular physicians "seldom contact" the ED, even if "they send a patient to the hospital," and ED physicians "rarely contact the primary-care docs either to clarify information or discuss treatment plans for a patient." However, when the two physicians "were able to connect on the phone, the result was often much more positive." Notably, physicians in the study "said sharing medical records is cumbersome no matter what the mode."
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Certain types of medical errors much less likely to occur at top-rated US hospital
March 10, 2011
HealthDay (3/9, Preidt) reported, "Certain types of medical errors are 46 percent less likely to occur at top-rated US hospitals than bottom- ranked hospitals," according to the annual HealthGrades Patient Safety in American Hospitals report. To reach that conclusion, "HealthGrades researchers analyzed 40 million Medicare patient records from 2007 to 2009 and focused on 13 patient safety indicators, such as bed sores, bloodstream infections from catheters, foreign objects left in the body after procedures, and excessive bleeding or bruising after surgery," then used "patient safety indicators published by the US Agency for Healthcare Research and Quality...to identify preventable medical errors and which hospitals were in the top five percent for avoiding those errors."
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Study suggests patients taking opioid painkillers not being monitored adequately
March 10, 2011
HealthDay (3/9, Dotinga) reported that although "opioid painkillers, such as oxycodone, can lead to addiction and overdose, people who take them are frequently not tracked by the primary care doctors who prescribed the drugs," according a study published in the Journal of General Internal Medicine. The researchers studied medical records of "more than 1,600 people who took prescription opioids for chronic pain for an average of two years." They found that "only 8 percent of patients overall, and 24 percent of those considered high-risk for abuse, underwent drug testing, and only half made regular visits to their doctors."
Reported by the American Association for Justice
Study finds screening mammography less accurate in breast cancer survivors
February 23, 2011
Bloomberg News (2/23, Wechsler) reports, "Mammograms are more likely to miss new tumors in women who have had breast cancer before than in those without a history," according to a study in the Journal of the American Medical Association. The study reviewed "58,870 mammograms for 19,078 women with a history of the disease and the same number of screenings for 55,315 women with no history." According to HealthDay (2/22, Doheny), the study was based on 12 years of data, in which mammograms "detected 76.5 percent of the cancers in women who had never had breast cancer and 65.4 percent in those who had previously had the disease." As for false positives, "1 percent of the women without a history of breast cancer were referred for biopsy but ended up being cancer-free, compared with 1.7 percent of those with a breast cancer history." MedPage Today (2/22, Neale) reported that the researchers said the difference was "driven largely by a lower sensitivity for the detection of invasive carcinomas." Meanwhile physicians "contacted by ABC News and MedPage Today agreed that the findings do not imply" that the yearly screening recommendation for breast cancer survivors "should be changed. The study 'does raise the question, however, as to whether supplemental screening with other modalities, notably ultrasound or MRI, is appropriate in a certain subset of these women,'" according to Carol Lee, MD, chair of the American College of Radiology's commission on breast imaging.
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FDA: More than 20 antipsychotics may pose risk to newborns when taken by pregnant mothers
February 23, 2011
Bloomberg News (2/23, Peterson) reports, "Johnson & Johnson's Risperdal (risperidone) and Eli Lilly & Co.'s Zyprexa (olanzapine) are among more than 20 antipsychotic drugs that US regulators said may pose risks to newborns when taken by mothers during pregnancy." The Food and Drug Administration has "updated labeling for antipsychotic drugs to show potential side effects to children born to mothers on the medicines in the third trimester." The agency said that the listed medications may "cause abnormal muscle movements and withdrawal symptoms in newborns." According to MedPage Today (2/22, Gever), the FDA is "requiring the standardized cautions be carried on all antipsychotic drugs -- 20 different types sold under 23 brand names." All the products are "approved to treat schizophrenia; some also have been cleared for bipolar disorder." They range from the first antipsychotic "used in modern practice, chlorpromazine (Thorazine), to such newer agents as aripiprazole (Abilify) and quetiapine (Seroquel)." Medscape (2/22, Lowes) provides a complete list of the drugs that will required warnings about the risk of extrapyramidal symptoms (EPS) and withdrawal syndromes in newborns; and the FDA, in a Safety Announcement, provides more details.
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Florida ruling tossing out tobacco class-action opened industry to litigation flurry
February 22, 2011
The AP (2/18, Anderson) reported Florida Supreme Court justices' 2006 ruling tossing out a $145 billion class-action damage award against tobacco companies "has helped generate more than $360 million in damage awards in only about two dozen cases." The ruling allowed approximately 8,000 individual members of the class to pursue separate lawsuits and use the findings from the class-action. As a result, plaintiffs "must mainly show they were addicted to smoking and could not quit, and that their illness - or a smoker's death - was caused by cigarettes." Edward Sweda of the Tobacco Products Liability Project suspected "if the losing trend and multimillion-dollar verdicts continue," tobacco companies would reconsider "their long-standing policy against settling the smoker lawsuits."
Reported by the Association for American Justice
FDA warns against using terbutaline for preterm labor
February 18, 2011
USA Today (2/18, Young) reports that the Food and Drug Administration is now "requiring stronger safety warnings for a popular treatment to prevent pregnant women from prematurely giving birth. Women should not be given injections of the drug terbutaline for more than three days 'because of the potential for serious maternal heart problems and death,'" the FDA said Thursday. The agency has approved terbutaline only to treat "specific respiratory conditions," such as asthma. Los Angeles Times (2/17, Healy) "Booster Shots" blog noted that terbutaline may "relax smooth muscles, including the uterus, thereby disrupting contractions in women who have gone into labor too soon." Although widely administered in hospitals as to forestall labor, physicians also "prescribe it in pill form to prevent premature labor in women who are carrying multiple fetuses or have a history of preterm labor." According to the MedPage Today (2/17, Frieden), the FDA said the label change was based on its review of post-marketing reports of "maternal death and serious cardiovascular adverse events" submitted to the Adverse Event Reporting System (AERS). An AERS search identified "16 maternal deaths" from the initial marketing of the drug in 1976 until 2009. In addition, the agency said it has identified "12 maternal cases of serious cardiovascular events associated with use of terbutaline that were reported between Jan. 1, 1998 and July 2009."
Reported by the American Association for Justice
Pfizer to pay $10 million compensatory damages in menopause treatment case
February 9, 2011
Bloomberg (2/9, Feeley, Milford) reports, "Pfizer Inc. must pay more than $10 million in damages to an Arkansas woman who blamed her cancer on the company's Prempro (conjugated estrogens and medroxyprogesterone) menopause drug, after an appeals court reinstated a jury verdict." A Pennsylvania appeals court "yesterday overturned a judge's ruling that Pfizer's Wyeth unit deserved a new trial in connection with Mary Daniel's claim that Prempro caused her breast cancer." Evidence in Daniel's case "showed that she took Prempro for about 16 months starting in December 1999 and was diagnosed with breast cancer in July 2001."
Reported by the American Association for Justice
VA finds more notification failures involving equipment concerns at Miami hospital
February 9, 2011
The Miami Herald (2/9, Tasker) reports, "The Veterans Administration said Tuesday it has found another 12 South Florida veterans who never were notified they might have received colonoscopies with improperly cleaned equipment at the Miami VA hospital as far back as 2004." The department, "which last year said it had taken extensive steps to prevent another such notification error, again blamed the way in which the hospital keeps medical records" both electronically and in supplemental paper log books. VA officials "said this error was discovered when the Miami US Attorney's Office, gathering information related to veterans who have filed lawsuits in the matter, asked the Miami VA hospital to recheck its records."
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GSK to settle rosiglitazone maleate death lawsuits
February 8, 2011
Bloomberg (2/9, Feeley, Milford) reports, "Pfizer Inc. must pay more than $10 million in damages to an Arkansas woman who blamed her cancer on the company's Prempro (conjugated estrogens and medroxyprogesterone) menopause drug, after an appeals court reinstated a jury verdict." A Pennsylvania appeals court "yesterday overturned a judge's ruling that Pfizer's Wyeth unit deserved a new trial in connection with Mary Daniel's claim that Prempro caused her breast cancer." Evidence in Daniel's case "showed that she took Prempro for about 16 months starting in December 1999 and was diagnosed with breast cancer in July 2001." Bloomberg (2/8, Feeley) reports, GlaxoSmithKline Plc "agreed to pay more than $250 million to resolve about 5,500 claims related to its Avandia (rosiglitazone maleate) diabetes drug and avoid the first trial over claims it can kill users, two people familiar with the accords said." GSK agreed to settle the lawsuits "claiming the drug causes heart attacks and strokes for an average of at least $46,000 each, said the people, who declined to be identified because they weren't authorized to speak publicly." On Sept. 23, GSK said it would "stop promoting Avandia worldwide after regulators said the treatment would be withdrawn from the market in Europe and sales would be limited in the US because of studies linking the drug to increased risks of heart attacks."
Reported by the American Association for Justice
GSK tightens restrictions on rosiglitazone label
February 8, 2011
MedPage Today (2/7, Gever) reported, "Obeying a 2010" Food and Drug Administration directive, GlaxoSmithKline, "the manufacturer of the star-crossed diabetes drug rosiglitazone (Avandia) has now finalized new label language -- restricting the drug's use to patients already taking it or to those who have failed other antiglycemic drugs." According to the new label, rosiglitazone "may be started only in patients who 'are unable to achieve adequate glycemic control on other diabetes medications, and, in consultation with their healthcare provider, have decided not to take pioglitazone (Actos) for medical reasons.'" HeartWire (2/7, O'Riordan) reported, "The new label has been changed to highlight the increased cardiovascular risks with the drug, noting in a boxed warning that in a meta-analysis of 52 studies, most of which compared rosiglitazone with placebo, the drug was associated with a significantly increased risk of MI." The new label highlights the "lack of comparative clinical trials between rosiglitazone and pioglitazone but notes that pioglitazone, in a study compared with placebo, was not associated with an increased risk of death or MI." In addition, the boxed warning "includes previous caveats that rosiglitazone is not recommended in patients with symptomatic heart failure and that it can exacerbate congestive heart failure in some patients." The AP (2/7) noted that late last year, the "Justice Department and several state attorneys general" were investigating the "development and marketing of Avandia." A Senate investigation "released last year concluded that Glaxo knew about the risks of its drug years before they were made public and withheld important data from the FDA." NPR 's (2/7, Hensley) "Shots" blog reported, "In September, FDA Commissioner Margaret Hamburg predicted the number of people taking Avandia would decline dramatically from around 600,000 at the time. She was right." Glaxo told "Shots about 100,000 people in the US are taking Avandia these days."
Reported by the American Association for Justice
Combined Avastin, chemotherapy treatment linked to higher mortality risk
February 2, 2011
USA Today (2/2, Szabo) reports, cancer patients treated with a combination of the angiogenesis inhibitor Avastin [bevacizumab] and chemotherapy are "50-percent more likely to die from their treatment rather than their disease," according to a study in the Journal of the American Medical Association. According to Bloomberg (2/2, Cortez), "Deadly side effects occurred in 2.5 percent of patients given Avastin, and were 46-percent more common in those getting it in a mix of medicines rather than chemotherapy alone" in the meta-analysis of 16 clinical trials "involving 10,217 patients." The Wall Street Journal (2/2, Dooren, Mundy) reports the most common causes of death were hemorrhages, neutropenia, and perforations in the stomach or intestines. The AP (2/2, Johnson) points out that it is "still unclear which patients are most likely to benefit" from bevacizumab. "Deaths from Avastin's side effects are rare and the small risk should be weighed against the drug's possible benefits," said senior study author Dr. Shenhong Wu of Stony Brook University Cancer Center in New York. Charlotte Arnold, a spokesperson for Avastin's maker, Genentech, "said the new analysis is based on known information and includes studies in cancer types for which the drug isn't approved." She said the company "supports research to find biomarkers that might reveal which patients may respond to Avastin.
MedPage Today (2/1, Bankhead) noted that in an accompanying editorial, University of Michigan oncologist Daniel F. Hayes, MD, "said key to striking a risk-benefit balance with bevacizumab will be the identification of patients who are most likely to benefit. .... 'Bevacizumab works well, but only in selected patients,'" Dr. Hayes emphasized. HealthDay (2/1, Gardner) added that a lung cancer expert, Dr. Roman Perez-Soler of the Montefiore Medical Center in New York City, pointed out that "lung cancer is one of the few malignancies in which Avastin has prolonged survival and thus might still have a place in this armamentarium." Meanwhile, the Los Angeles Times (2/2, Forgione) "Booster Shots" blog notes that Avastin also "made news in December" when the FDA moved to "begin the process of withdrawing approval of Avastin as a treatment for breast cancer because the federal agency found no evidence that it extended the lives of women who had the disease." Genentech requested a "hearing appealing" the agency's proposed withdrawal; and the drug was "still approved for kidney, brain and lung cancers."
Reported by the American Association for Justice
