Other News
Toyota memo shows employees warned manages about safety concerns in 2006.
(From the AAJ News Brief of March 8, 2010)
The Los Angeles Times (3/8, Glionna) reports that a group of six "veteran" Toyota union employees sent a memo to the company's senior management that they knew "could damage their careers. The workers had recognized a troubling trend. In recent years, the automaker had kicked into high gear to fill the booming U.S. demand for smaller, more gas-efficient vehicles," and in doing so, took "dangerous safety and manpower shortcuts to lower costs and boost production. ... From 2000 to 2005, their memo pointed out, Toyota had recalled more than 5 million cars -- 36% of all sold vehicles, a rate higher than other companies. Toyota's failure to act, the two-page notice warned, may 'become a great problem that involves the company's survival.'" The Times notes that despite the workers' fears, "Toyota never responded."
Toyota planning to demonstrate safety of electronics. NBC Nightly News (3/7, story 4, 1:20, Holt) reported, "Toyota plans to go on the offensive this week to try to control the damage from continuing safety questions," noting that the automaker plans to continue to refute allegations that electronic throttle controls are to blame for unintended acceleration in its vehicles. "tomorrow Toyota engineers will hold a demonstration. And they're going to broadcast it around the country." The piece reports that Toyota's goals are to "convince lawmakers and regulators in Washington that electronics are not the problem" and to "convince buyers out there who still might be a little skeptical that Toyota has fixed the problem."
USA Today (3/8, Woodyard, O'Donnell) reports that "A professor's experiment, demonstrated in an ABC News report and described in congressional testimony, alleged that Toyota Avalon's electronic controls were vulnerable to short circuits. Toyota's report today says the experiment's 'highly artificial conditions' would not occur in real use." This piece notes that House members investigating Toyota have demanded more stringent documentation on Toyota's investigations of potential electronic faults, noting that NHTSA reported last week that dozens of Toyota drivers are reporting cases of unintended acceleration after undergoing Toyota's recall process.
Family of Toyota crash victims set to sue. The Minnesota Lawyer (3/5, Lore) reported, "An attorney for the family of three people killed when their vehicle was struck by a Toyota Camry four years ago is convinced he'll be able to prove that a defect in the Camry was the cause of the crash. The case has already garnered national attention because the driver of the Camry, who has spent the last two years in jail, is seeking release based on recent revelations about acceleration problems with Toyota vehicles." The plaintiffs "are exploring claims grounded in product liability, wrongful death, negligence and strict liability, according to [attorney Michael] Padden, who, along with Texas attorney Robert Hilliard, represents Bridgette Trice, Carolyn Trice, and Quincy Adams."
Glaxo takes aim at Senate Finance Committee report on Avandia.
(From the AAJ News Brief of Feb. 25, 2010):
The AP (2/25, Perrone) reports that "GlaxoSmithKline said Wednesday a Senate report criticizing its handling of heart risks with its diabetes drug Avandia [rosiglitazone] 'mischaracterizes and distorts' the company's record." Glaxo, "in a memo posted online...takes aim at the highly critical Senate Finance Committee report that has reignited debate around its troubled diabetes treatment." That "report, issued over the weekend, charged that Glaxo downplayed the drug's safety risks and withheld important data from the FDA."
Bloomberg News (2/25, Cortez) reports that "the company diligently studied the drug's safety and effectiveness, and communicated its findings to governments, regulators, scientists and doctors...Glaxo said in [the] statement." Bloomberg points out that the FDA "plans to convene an advisory panel hearing in July to consider the results of new studies on Avandia. Until then, patients should continue taking it, the agency said." Reuters (2/24, Hirschler) also covered the story.
Toyota facing Criminal probe over unintended acceleration.
(From the AAJ News Brief of February 23, 2010)
Potential criminal charges for Toyota over its safety issues led ABC's evening newscast and generated reports on both other networks, as well as coverage in major papers. NBC Nightly News (2/22, story 4, 1:40, Williams) reported on "the latest trouble for Toyota," noting that "a federal grand jury and the Securities and Exchange Commission are involved. Toyota says it has been subpoenaed to turn over documents. Now this comes after internal memos came to light that show Toyota executives boasting they were able to get federal regulators to stop looking into acceleration complaints in 2007 when Toyota replaced floor mats. It didn't make repairs, so that saved $100 million. Take all of these developments and you have a starting point for congressional hearings" in which Toyota's "North American executives" and CEO Akio Toyoda are scheduled to testify.
ABC World News (2/22, lead story, 3:30 Sawyer) also reports on the "startling new possibility" that Toyota could face criminal charges. "The Chairman of the House Commerce Committee today alleged Toyota has misled the public about the cause of its runaway cars, ignoring problems that could come from its electronics. Toyota has said repeatedly that they have not had a problem with electronics. But what I saw this weekend suggests otherwise."
The CBS Evening News (2/22, story 3, 2:30, Attkisson) reports, "We did obtain that one internal document in particular that could be devastating to Toyota's claim that electronics aren't an issue. CBS News has learned that as early as 2005 Toyota engineers were redesigning software in response to complaints of cars surging unexpectedly. That could be crucial, because publicly, Toyota has insisted for six years through eight federal investigations that electronics are not to blame when its cars surge, sometimes out of control. Instead, Toyota faults drivers, floor mats, and, more recently, sticky gas pedals."
The AP (2/23, Thomas, Strumpf) adds that Toyota announced the federal criminal investigation as the SEC "was probing what the automaker told investors." Meanwhile, "Newly released internal documents showed that Toyota officials visited with U.S. regulators years ago who 'laughed and rolled their eyes in disbelief' over safety claims. The twin developments created new public relations challenges for Toyota plus the prospects - however likely or unlikely - of hefty federal fines or even indictments against executives in the U.S. and Japan. They also complicate Toyota's ability to discuss details driving its recall of 8.5 million vehicles because anything executives say could be used against the company inside a courtroom."
Waxman faults Toyota, NHTSA. The New York Times (2/23, B5, Maynard) that House Energy and Commerce Chairman Henry Waxman and Rep. Bart Stupak, a committee member, wrote to Toyota US sales chief James Lentz that "Toyota relied on a flawed study in dismissing the notion that computer issues could be at fault for sticking accelerator pedals, and then made misleading statements about the repairs." Meanwhile, "in a separate letter to the transportation secretary, Ray LaHood, they said they also were concerned about the competency of investigations into Toyota's problems by the" NHTSA
NHTSA woes seen as analogous to earlier FAA problems. In a column in Corporate Counsel (2/23), David Hechler wrote, "As congressional hearings on the recent recalls of Toyota Motor Sales USA Inc. vehicles kick off Tuesday, questions are certain to arise about the way the National Highway Traffic Safety Administration handled its investigations of the automaker. As lawmakers from various committees prepare their questions, they would do well to recall a 2008 House Transportation and Infrastructure Committee hearing that probed revolving-door hiring practices in the airline industry between a regulated company and its government regulator."
Toyoda vows improved safety. In an op-ed in the Wall Street Journal (2/23), Toyota CEO Akio Toyoda writes that that company's recall crisis has been "humbling" and expresses personal dismay over the crisis. He reaffirms the company's commitment to safety and assures that it will renew its efforts to ensure safety and quality.
Lawsuits filed against Toyota. The Recorder (2/23, Moser) reports, "A woman whose daughter died in 2007 when her Toyota Yaris unexpectedly accelerated and plunged off of a Pennsylvania highway filed suit in Central District court on Monday, represented by San Francisco lawyers at Lieff Cabraser Heimann & Bernstein."
The AP (2/22) reported, "A Long Island woman has filed a wrongful death lawsuit against Toyota for the 2007 death of her 21-year-old daughter."
"Lost value" lawsuits seen as most significant source of liability for Toyota. In a column in Forbes (2/22), analytical services company Oxford Analytica wrote that lawsuits against Toyota will include "traditional product liability claims," as well as "claims that seek to recover cars' 'lost value'" and "shareholder suits that seek to recover for the drop in the company's share price." The column assesses the lost value suits as posing the greatest threat, commenting that "the last several years have seen a significant scaling back in corporate legal liability for defective products, as a result both of legal reforms initiated at the federal and state levels and decisions by the U.S. Supreme Court that have sharply limited the award of punitive damages."
FDA urged to ban sales of fibromyalgia treatment.
On January 21, 2010 the Associated Press reported that a consumer advocacy group, Public Citizen, has asked the FDA "to pull Savella off the market, almost exactly a year after it was cleared to treat fibromyalgia." Savella, which is co-marketed by Forest Laboratories Inc. and Cypress Bioscience Inc., came under scrutiny after "company studies of the drug showed 20 percent of patients taking Savella had hypertension, or high blood pressure." The FDA is said to have already cleared two other fibromyalgia treatments. Public Citizen said the drug had already been rejected by European regulators who found the benefits to be "marginal." Sidney Wolfe, director of Public Citizen's Health Research Group, said the drug posed "serious safety risks that outweigh the benefits," according to Bloomberg News.
Graco recalls 1.5M strollers after injury reports.
On January 20, 2010, the Associated Press reported that approximately 1.5 million Graco strollers sold at AFES, Burlington Coat Factory, Babies R Us, Toys R Us, Kmart, Fred Meyer, Meijers, Navy Exchange, Sears, Target, Walmart and other retailers from October 2004 and December 2009 are being recalled after some children's fingertips were amputated by hinges on the products." Several children "had their fingertips severed and two children received cuts on their fingertips." In an announcement January 20th, the CPSC "said the strollers pose an amputation and laceration hazard to children when opening or closing the canopy." "The recall covers those Graco Passage, Alano and Spree strollers and travel systems with a plastic, jointed hinge mechanism that has indented canopy positioning notches, the agency said." The CPSC said consumers should immediately stop using the recalled strollers and contact Graco to receive a free protective cover repair kit.
FDA accuses Johnson & Johnson of failing to properly investigate Tylenol contamination reports.
On January 14, 2010 the Dow Jones Newswire reported that the FDA determined that McNeil Consumer Healthcare failed to properly test Tylenol for contamination after multiple consumer complaints in 2008. Johnson & Johnson manufactures Tylenol. The FDA says that the company did not initiate a formal investigation after it received complaints of a musty odor in Tylenol Arthritis Caplets from over 70 consumers. A spokesperson at McNeil said that the company is "actively working in consultation with the FDA to address their concerns."
Baxter may face product-liability suits over tainted heparin.
On January 13, 2010 the Bloomberg News reported that, "Baxter International Inc., which recalled its blood thinner heparin amid reports of allergic reactions and deaths in 2008, faces at least 30 lawsuits in Chicago by injured people or their estates." Meanwhile, "as many as 300 product-liability complaints may be filed in the Illinois state court, plaintiffs' attorney Allen Schwartz of Kralovec, Jambois & Schwartz said." The manufacturer "began a voluntary recall after its monitors noticed an increase in reports of allergic reactions to injections of the drug, said Erin Gardiner, a company spokeswoman." But, Gardiner noted that "a large number of claims" may not "involve contaminated heparin or in some cases, even Baxter heparin."
FDA letters cite Lilly, Bayer, Amylin, Cephalon over misleading promotional materials.
On January 13, 2010, the AP reported that the FDA "issued enforcement letters to Eli Lilly, Bayer, Amylin Pharmaceuticals, and Cephalon for making inaccurate or incomplete statements while promoting their drugs." In its letter to Lilly, the FDA cited a "print advertisement for the antidepressant Cymbalta, which is approved to treat depression, generalized anxiety disorder, diabetic nerve pain, and the pain ailment fibromyalgia." The FDA indicated that the print ad fails to "adequately display information about the drug's side effects." The Dow Jones Newswire reported that the FDA said the weight-loss benefits of Byetta (for diabetes) were overstated by Amylin and Lilly representatives. The Dow Jones Newswire further reported that women using Mirena (a method of birth control) are not adequately warned of miscarriage risks, should they become pregnant while using the medication manufactured by Bayer. Reuters reported that Cephalon, the maker of Treanda (a treatment for lymphoma), did not include important risk information on its dosing card. The FDA asked that the drug makers stop using its current advertisements and promotional materials immediately.
Second store pulls cadmium jewelry, CPSC launches investigation.
On January 12, 2010, the AP (along with hundreds of other news websites) reported that the CPSC announced it was "opening an investigation into the AP's findings, and China's government also took notice of the trouble brewing in its largest export market." The announcement came after AP's story that reported that manufacturing factories in Yiwu (a city on China's east coast) said that profit is a top priority which in turn means using lower-quality materials, such as cadmium, which is known to cause cancer. In a separate story that also appeared on January 12, 2010, the AP reported that "[t]he jewelry and accessories store Claire's... joined Wal-Mart Stores Inc. in saying it would stop selling any item cited in an Associated Press investigation of the presence of cadmium in cheap bracelets and charms."
Appeals court reinstates hormone replacement drug lawsuits.
On January 7, 2010 the AP reported that on January 6, 2010, the 8th US Circuit Court of Appeals in St. Louis, MO, "reinstated more than 100 lawsuits against drug companies filed by women or their surviving relatives who claimed that hormone replacement therapy caused breast cancer." The move overturned "a 2008 district court ruling that had blocked almost all of the suits from being sent back to state court in Minnesota and dismissed most of the lawsuits that were being heard in Little Rock." The appeals court also "reversed the dismissal of dozens of cases that the lower court ruled should not have been part of the litigation because they duplicated claims pending in California." Most of the lawsuits "focus on the drug Prempro [conjugated estrogens and medroxyprogesterone]," which was "prescribed to treat" menopausal symptoms, the AP said.
Studies question FDA approvals of cardiac devices.
On December 30, 2009, the New York Times reported on two studies that have "found shortcomings in some clinical trials accepted by the FDA over the last decade in connection with the approval of high-risk cardiovascular devices," such as "pacemakers, implanted defibrillators, and...coronary stents." The FDA said that it "is developing guidelines that will set tougher scientific standards for data from tests on humans" that medical device makers submit.
A study published in the December 30th issue of the Journal of the American Medical Association, showed that many cardiovascular devices "are not subjected to rigorous safety and effectiveness research before being approved for use," stated an article in the Los Angeles Times. The study stated that "it's common for such devices to receive...approval based on information from only a single study, which 'raises questions about the quality of data on which some cardiovascular device approvals are based.'"
The Wall Street Journal reported on a second study, that appeared in the American Journal of Therapeutics. This study found that studies submitted for approval of cardiovascular devices often lack important information, including details on the studies' participants.
Radiation overexposure from CT scans may be more widespread than previously estimated.
On December 14 and 15, 2009 several news agencies (The CBS Evening News and NBC Nightly News on 12/14 and USA Today, Wall Street Journal, Los Angeles Times and Bloomberg News on 12/15) reported that over exposure to radiation from CT scans may be more widespread than previously thought. In a study published by the Archives of Internal Medicine, researchers at the National Cancer Institute "found that people may be exposed to up to four times as much radiation as estimated by earlier studies" when undergoing CT scans. However, James Thrall, chairman of the American College of Radiology, stated that "scientists have not yet determined whether low doses of radiation actually increase cancer risk, or whether the risk rises only after exposure levels reach a certain threshold." Bloomberg News reported that in a "National Cancer Institute study, the authors predicted that lung cancer will be the most common radiation-related cancer followed by colon cancer and leukemia." Bloomberg further reported that the FDA issued interim regulations on December 7, 2009 that "required closer monitoring of CT scans after more than 250 cases of exposure to excess radiation were reported since October."
Psychotropics prescribed to Illinois foster children without consent, investigation finds.
On December 10, 2009, the Chicago Tribune reported that hundreds of Illinois foster children were prescribed "powerful mood-altering medications" without the required consent of state child welfare officials. "According to a Chicago Tribune analysis of 'government data,' in 2007, 'psychotropic medicines were administered to some 240 foster children without the state's consent.'" The Department of Children and Family Services consented to "the psychotropic medication of 3,320 wards," however, "separate Medicaid prescription records show the drugs were administered to 3,564 wards." In a separate article published the same day, the Chicago Tribune reported that Streamwood Behavioral Health Center," dosed foster children with dangerous combinations of mood-altering" medications, "sometimes using the medicines as 'chemical restraints' to control youth who needed counseling." The report by the University of Illinois at Chicago's department of psychiatry further stated that the center, "which has treated roughly 475 Department of Children and Family Services wards since 2007, is 'so understaffed as to be counter-therapeutic,'" and that "hospital staff resorted to extraordinarily high rates of emergency psychiatric medications, physical restraints, and seclusion."
Amgen accused of kickback scheme to boost Aranesp sales.
On October 31, 2009, the New York Times reported that "biotechnology giant Amgen has been accused by New York and some other states of engaging in illegal kickbacks to promote sales of its anemia drug Aranesp [darbepoetin alfa]." Associated Press reported that the "states involved in the lawsuit include California, Delaware, Florida, Hawaii, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Nevada, New Hampshire, New York, Tennessee, and Virginia, along with the District of Columbia." The lawsuits filed allege that Amgen provided free samples of Aranesp "to doctors and clinics by putting tiny extra amounts of the drug in each vial. The medical practices could then make a profit by billing insurers...for the extra drug."
Study finds Aranesp nearly doubles risk of stroke.
In related news, on October 31, 2009 the Associated Press reported on a "new study" published on-line by the New England Journal of Medicine that "raises fresh safety concerns about widely used anemia medicines, finding that the drug Aranesp [darbepoetin alfa] nearly doubled the risk of stroke in people with diabetes and chronic kidney problems who are not yet sick enough to need dialysis." The study of "4,038 people with type 2 diabetes, kidney problems, and moderate anemia" found that strokes "occurred in 101 patients given Aranesp and 53 patients given" a placebo shot. The study's authors concluded that for many patients, "this risk will outweigh its potential benefits." Aranesp's maker, Amgen, said it will share the "information with drug regulators and expects the results of the study will lead to changes in the official prescribing information guiding Aranesp's use."
Paxil - From the American Association for Justice (AAJ News Brief) - October 14, 2009
Glaxo ordered to pay $2.5 million over claims linking Paxil to birth defects.
"Bloomberg News (10/14, Feeley, Pearson) report, "GlaxoSmithKline Plc must pay $2.5 million over claims that its Paxil [paroxetine] antidepressant caused birth defects, a Pennsylvania jury concluded in the first of 600 such cases to come to trial." The suit alleged that Glaxo "knew Paxil caused birth defects and hid the risks to increase profits." The jurors found 10-2 that "Glaxo failed to properly warn doctors and pregnant users of Paxil's risk," awarding "compensatory damages to the family of Lyam Kilker."
The jurors concluded that Paxil "was a 'factual cause' of the child's heart defects," the Philadelphia Inquirer (10/13, Hill) reported. But, "Glaxo issued a statement saying it disagreed with the verdict and would appeal." Glaxo noted that "the scientific evidence does not establish that exposure to Paxil during pregnancy cause" the birth defects."
Heparin Contaminations
On October 12, 2009 MedPage Today reported that, "Lax compliance with federal regulations resulted in bacterial bloodstream infections from contaminated heparin syringes in several states, according to a new Centers for Disease Control and Prevention report," published October 12th in the Archives of Internal Medicine. The article further stated that the CDC report has also "raised concerns about drug safety in an increasingly complex pharmaceutical industry." CDC investigators "traced the infections to syringes of the blood thinner heparin produced by a single company... .."The CDC had difficulty in determining where the contaminated syringes originated because they were not marked by the name of the original manufacturer and were sent to multiple distributors before they reached patients. The company was not named in the report. The report also stated that the company had violated the FDA's Good Manufacturing Practices.
