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Tuesday, August 24, 2010

Wyeth v. Levine Breathing New Life into Drug Negligence Cases

In 1996, Wyeth brought to market a weight-loss drug called Redux. Within less than 2 years, the drug was pulled from the market because it led to significantly elevated risks of pulmonary hypertension. Pulmonary hypertension, elevated blood pressure in the arteries of the lungs that forces the heart to work harder, can lead to progressive heart failure and death. After the drug was approved, a number of people who suffered this serious adverse side effect pursued lawsuits to get compensation on the basis of state laws.

The family of one woman who died of pulmonary hypertension after taking Redux attempted to pursue a pharmaceutical injury lawsuit alleging that Wyeth was negligent for marketing the drug at all. The lawsuit was stopped in 2008 when the judge in Cleveland gave summary judgment to Wyeth because he believed that federal law pre-empted state-based claims of negligence. The judge said that, by approving the drug, the FDA essentially gave its manufacturer and marketer a free pass. This argument is the one most commonly pursued by drug companies.

However, since the ruling in Wyeth v. Levine, drug lawsuits all across the country are being revived by a commonsense recognition that just because the FDA is supposed to stop dangerous drugs from being marketed, its approval does not absolve drug companies from responsibility if the products they market are dangerous. For example, a major case about anti-acne drug Accutane was reversed in reference to this groundbreaking decision.

And last week, the United States District Court of Appeals for the Sixth Circuit also revived this case against Redux. The Court decided that the lawsuit, brought by her estate, can proceed. This decision came over the arguments by Pfizer (who now owns Wyeth) that Wyeth v. Levine applied only to failure-to-warn lawsuits and not to strict negligence lawsuits.

Although it is impossible to know how the drug lawsuit will play out, it seems hard to ignore that Wyeth must have known what it was getting into with Redux. During the pre-approval hearings, its experts claimed that the drug had a "very favorable safety profile," but studies had shown that the drug caused at least a ninefold increase in the rate of pulmonary hypertension. After approval for short-term use in France, the drug resulted in about 20 percent of that country's pulmonary hypertension cases. Continuing to pursue marketing for a drug knowing that it posed that level of threat definitely seems to constitute negligence.

If you or a loved one has suffered serious injury as a result of taking a pharmaceutical drug, you may be able to receive compensation for your injuries, even if a previous court decision has dismissed your claim. The Cochran Firm is prepared to fight for all victims of pharmaceutical drug injury, and may be able to help you. To learn more, please contact us today for a free initial case evaluation.

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posted by Benjamin A. Irwin at 3:25 PM

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