Wyeth v. Levine Used to Reverse Pre-Emption of Chicago Pharmaceutical Litigation Case Against Glaxo Smith Kline (GSK)
An Illinois prescription drug case that originally had been dismissed due to issues of federal preemption, has been reinstated by the 7th Circuit Court of Appeals in Chicago. This case, Mason v. SmithKline Beecham Corp. d/b/a Glaxo SmithKline, No. 08-2265, may be the first decision that addresses preemption with respect to prescription drugs.
The original Illinois prescription drug lawsuit was brought by the parents of 23 year-old Tricia Mason after she committed suicide just two days after being started on the prescription drug Paxil. The Illinois prescription drug lawsuit alleged that Paxil increases the risk in suicide in children and young adult, which the manufacturer should have known and therefore had a duty to warn its users.
The lawsuit alleged that GSK violated Illinois law by choosing not to warn Tricia Mason on its label that Paxil increases the risk of suicide for children and young adults. Two years after the decedent's suicide, Paxil added a label warning of an increased risk of suicide among children taking the drug.
In De Bouse, the plaintiff was claiming economic damages against Bayer AG, the manufacturer of the drug Baycol. The plaintiff had purchased and taken Baycol on three occasions prior to the drugs withdrawal from the market for its potential harmful side effects. It is important to note that the plaintiff was not alleging any damages due to the
On May 1, 2009, the FDA announced that it had been made aware of 23 reports of adverse liver effects that occurred in the course of normal Hydroxycut usage. The reports included injuries that ranged from general liver damage, the need for a liver transplant, and to death. At that time the
While the FDA has not specified exactly how many products fall into this category, it advised that consumers not to purchase and use products labeled with words such as “anabolic” or “tren” or phrases like “blocks estrogen” and “minimizes gyno”. In addition, the FDA cautions consumers to be wary of body-building products claiming to enhance or diminish the effects of hormones like testosterone, estrogen or progestin.
Chicago and Illinois residents have reported symptoms of adverse affects from taking Hydroxycut, which range from stomach and abdominal pain, excessive fatigue, recurring headaches, excessive weakness, vomiting, loss of appetite, to kidney failure and liver damage severe enough to require a liver transplant.
On May 1, 2009 the
The case centered on the physician who had prescribed Fleet Phospho-Soda, an over-the-counter oral laxative used to cleanse the system pre-colonoscopy.
Studies have revealed that the link between Fleet Phospho-Soda and these side affects could be the result of calcium phosphate tubules that form in a kidney, which can lead to acute renal failure.
While my brother dismisses drug company's efforts to win doctors over with pens and notepads, there is a lot of skepticism raised by watch groups about the impropriety of doctors promoting pharmaceuticals especially given the rise of
In Giles, the plaintiff decedent, Jeff Giles, was a coal miner and who became depressed after the coalmine where he worked closed and he lost his job. He was diagnosed with major depressant disorder, for which his physician prescribed the antidepressant Effexor. He committed suicide 2 days after taking three Effexor pills. His wife and son brought an
Perhaps even more alarming is that at least half of these dangerous interactions involve the use of over-the-counter medications, such as aspirin or dietary supplements. According to the study, one in 25 older adults are at risk for serious drug interactions, the study has found. And for men ages 75 and 85, the risk is as high as 1 and 10.
However, not only those taking Tamoxifen need to worry. Experts say that regardless of the disease, most drugs work for only about half the people who take them. Not only is much of the nation’s approximate $300 billion annual drug spending wasted, but patients are being exposed unnecessarily to risky side effects.
And not just the FDA are upholding and propagating these preemption clauses- the U.S. Supreme Court has also supported pre-emption laws that prevent claimants from filing civil law suits against deep-pocketed drug and medical device companies in state courts.
The legal advice comes from top doctors and editors of the New England Journal of Medicine who have submitted a friend-of-the-court brief. The doctors state that the Food and Drug Administration (FDA) “is in no position” to guarantee drug safety. The doctors went on to to say that lawsuits can serve as “a vital deterrent” and protect consumers if drug companies don’t disclose risks.
The plaintiffs' son was prescribed Paxil by his dermatologist, not for his acne, but to treat a psychiatric disorder in which the individual is overly concerned about real or imagined defects in their physical appearance. Shortly after the second prescription of Paxil was refilled, the plaintiff's son committed suicide.