Supreme Court Hearing To Affect Future Drug Lawsuits

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The U.S. Supreme Court next week will begin hearing the case of Wyeth v. Levine, which centers on the question of whether FDA approval of a drug warning label pre-empts drug safety lawsuits brought in state courts over defective drugs, the Wall Street Journal reports.

The case involves Diana Levine, who lost her hand and forearm to gangrene after she received an injection of the nausea medication Phenergan into an artery during a push IV injection, which is more potent and takes less time to act than a traditional injection. The Phenergan label, which the FDA approved, includes a push IV injection as an option for administration but warns about risks associated with the practice, such as gangrene.

Levine filed a lawsuit against Wyeth in state court in Vermont over alleged problems with the Phenergan label, and a jury ruled in her favor. The Vermont Supreme Court upheld the decision. In an appeal to the U.S. Supreme Court, Wyeth argued that FDA approval of medication labels precludes lawsuits in state courts filed over alleged problems with the labels.

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In February, the Supreme Court ruled in favor of pre-emption in a case involving the medical device company Medtronic. In addition, Justice Stephen Breyer in a “testy burst” during a recent drug-related case asked the plaintiff’s lawyer whom she would rather have in charge of whether drugs should be allowed on the market: “an expert agency, on the one hand - or 12 people pulled randomly for a jury role who see before them only the people whom the drug hurt, and don’t see those who need the drug to cure them?” According to the Journal, the Bush administration “has long promoted the idea that federal law pre-empts state lawsuits.”

Consumer advocates say patients’ ability to bring drug lawsuits in state courts is their only defense against corporate misbehavior, such as instances where FDA reviewers make a mistake or firms hide information. The New England Journal of Medicine in August published an editorial in favor of Levine that made similar arguments. Rein said that a ruling in favor of pre-emption would make it more difficult for people harmed by drugs to obtain compensation, but noted that Congress should establish a fund for such patients, as it did for vaccine-related injuries.

According to the Journal, a ruling in favor of pre-emption could heavily affect the drug industry. Recent cases that would have been affected include a $68 million settlement by Johnson & Johnson over its Ortho Evra contraceptive patch, more than $1 billion in settlements by Eli Lilly over its antipsychotic drug Zyprexa and $4 billion in payments so far by Merck over lawsuits involving its pain pill Vioxx.

Reported by Drug Injury Blog.

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Comments

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