Articles Posted in Pharmaceutical Litigation

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The 7th U.S. Circuit Court of Appeals in Chicago affirmed a Southern District of Illinois judge’s ruling by the district judge in the regarding Wyeth, Inc.’s antidepressant Effexor . Giles v. Wyeth, Inc., No. 07-3149.

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 Illinois wrongful death lawsuit against Wyeth.

Effexor carries various warnings, one of which is a suicide precaution. In June 2003, the Food and Drug Administration (FDA) announced it was reviewing reports of a possible relationship between Paxil, an antidepressant not manufactured by Wyeth, and an increase risk of suicide and suicide attempts in children and adolescents. In 2003, Wyeth changed Effexor’s labeling to reflect that its pediatric clinical trial showed an increased risk of suicidal ideation in children using the drug.

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In its recent ruling the U.S. Supreme Court ruled that premarket approval from the Food & Drug Administration (FDA) does not preempt pharmaceutical companies from being held liable when their drug fails to meet state standards. In Wyeth v. Levine the court held that drug manufacturers can be sued in state courts even when they follow the rules and standards set out by the FDA.

Wyeth v. Levine involves a female, Vermont musician who lost part of her right arm after Wyeth’s drug Phenergan was injected into one of her arteries. The drug’s FDA-approved warning label warned against administering the drug this way, but did not prohibit it.

Wyeth argued that they were not required to change their labels to comply with Vermont regulations and that meeting the federal standards was enough. Levine argued that she was able to bring a liability claim under Vermont law even though Wyeth complied with federal standards.

The key issue of the case was whether or not Levine’s claim was preempted since Wyeth met the federal standards. The Supreme Court ruled that the case was not preempted and that Levine is able to bring a claim under Vermont law.

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A new study by researchers at the University of Chicago Medical Center has stated that at least 2.2 million U.S. adults take medicine in combinations that could trigger dangerous drug interactions. Some of the possible dangerous interactions include muscle breakdown, gastrointestinal bleeding, disruption in heart rhythm, and other serious problems.

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, the risk might be even higher because the research focused on major interactions among the 20 most common drugs and dietary supplements. “The public has an awareness that two prescription medications used together might be dangerous,” said the study author, Dr. Stacy Tessler Lindau. Lindau is the assistant professor of geriatric medicines, obstetrics and gynecology at the University of Chicago Medical.

The dangerous drug interactions cited in the study were more a byproduct of individuals unknowingly mixing medications rather than the result of pharmaceutical prescription errors by medical providers.

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Imagine you had been taking the drug Tamoxifen in hopes of preventing a recurrence of your breast cancer. Then a new test comes out that suggests that because of your genetic makeup the drug is not doing you any good. This situation is not that uncommon for hundreds of thousands of women in this country, including Illinois, who have been taking Tamoxifen.

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.

Many policy experts are calling for more studies to compare the effectiveness of different treatments. There is much hope riding on the promise of “personalized medicine” in which genetic screening and other tests give doctors more evidence for tailored prescriptions. Personalized medicine would go beyond the norm by determining which drug or drugs are best suited for which patient, rather than continuing to treat everyone the same in hopes of benefiting the fortunate few.

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In a recent and controversial accusation, Elsevier has been questioned about publishing favorable medical reviews of pharmaceutical company Wyeth’s hormone replacement therapy drug. The allegations claim that the medical publishing editors at Elsevier were not unbiased, but received payment from Wyeth. In response to these accusations, Elsevier has launched its own investigation into the legitimacy of the claims.

Senator Charles E. Grassley, Iowa (R) was the person who first questioned the article. As a member of the Senate Finance Committee, Grassley is investigating drug companies’ influence on doctors and contends that Wyeth, the pharmaceutical giant, commissioned ghostwriters to plug its drugs through several academic journals, including perhaps Elsevier.

The Elsevier article in question by Dr. John Eden was published in a May 2003 issue of the American Journal of Obstetrics & Gynecology. Progestins and Breast Cancer (Am J Obstet Gynecol 2003;188:1123-31), stated that drugs such as Wyeth’s Prempro could not be tied to breast cancer as there was “no definitive evidence” that the hormones caused breast cancer. Eden’s article was published a little over a year after a landmark federal study linking Wyeth’s Prempro hormone product to breast cancer.

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Since early 2006, drug and medical device companies have been on an unprecedented roll as pre-emption clauses become more and more prevalent. Despite recent controversies over prescription drugs like Vioxx and Celebrex, drug companies continue to successfully utilize Federal Drug Administration (FDA) policies to shield drug companies from civil lawsuits in the form of pre-emption clauses. This has far-reaching effects on pharmaceutical liability lawsuits in Illinois and the rest of the country.

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 beginning of the preemption era can be traced back to January 2006, when the FDA issued a statement of its new labeling policy under the “Laws, Acts, and Rules > New Requirements for Prescribing Information.pdf.” This policy not only set out labeling requirements, but also deemed that if the FDA approved the labeling then this alone “pre-empts conflicting or contrary state law”.

The federal pre-emption clauses have little or no bearing on FDA drug recalls, which can be initiated by the FDA, by FDA statutory authority, or by the drug company itself. The FDA maintains a list of recent drug recalls.

Yet the seemingly simple pre-emption declaration had far-reaching effects within the legal community and reversed decades of policies enforcing state’s rights to civil enforcement of liability law. This was done without a public notice or hearing- instead it was quietly tacked on to the labeling policy.

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The United States Supreme Court is expected to hear the case of Wyeth v. Levine this November which could have far reaching implications as to pharmaceutical litigation cases against drug companies, including those in Illinois and the Chicago area. 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 underlying case is about Diana Levine, a Vermont guitarist, who lost her right arm below the elbow after being injected with the drug Phenergen, a medicine used mostly for nausea. She sued the drug manufacturer, Wyeth, contending that the drug company had a duty to warn consumers that injections, like the one she experienced, could have devastating consequences. The state courts in Vermont agreed with Ms. Levine in awarding her nearly $7 million.

But Wyeth appealed stating that it was protected from such lawsuits. It argued that the FDA’s judgment could not in effect be overruled by a state court. FDA scientists had weighed the risk and benefits of Phenergan in approving the drug’s safety literature as a guide for doctors. The FDA was aware of the risks associated with injecting some forms of Phenergan, but the label did not specifically warn about the technique used for this patient.

It has been commented before that the FDA has been the “gold standard” in drug evaluation. The New England Journal of Medicine editors warned the justices to be skeptical in taking such a view now.

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Much has been said about the preemption of state actions for Illinois personal injury cases or Illinois wrongful death lawsuits. A recent federal district court decision ruled that a failure-to-warn lawsuit is not preempted by the federal statutes. The suit was brought by the parents of a teenager who committed suicide while taking the antidepressant Paxil.

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.

The parents alleged that the pharmaceutical company was liable for their son’s death because it failed to warn the physician about the risk of suicide that the drug posed to children and adolescents. The court rejected the argument raised by pharmaceutical giant, Glaxo-SmithKline (GSK), that preemption applied to this case.

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