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 product safety suits brought in state courts, the Wall Street Journal reports (Mundy/Wang, Wall Street Journal, 10/27). 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 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 (Kaiser Daily Health Policy Report, 10/3).

The current Supreme Court -- "one of the most pro-business ones in 50 years," according to the Journal -- in February 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."

Comments
Wyeth officials noted that the suit does not allege that the firm knowingly sold a dangerous product and that it complied with FDA guidelines for the drug's label. In addition, Wyeth officials said that strengthening the label to comply with stricter Vermont law would have been a violation of federal law. Bert Rein, lead outside attorney for Wyeth, said, "It would be a chaotic system if you can relabel anything as long as you mumble safety." However, Rein said he did not know of any instances where FDA had punished a firm for increasing the emphasis of a warning label.

Levine's lawyers say federal law is not intended to prevent drugmakers from taking proactive steps to enhance warnings to doctors and consumers. According to the Journal, they say FDA guidelines "are the floor, not the ceiling, when it comes to safety standards."

Consumer advocates say patients' ability to sue 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.

Implications
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 anti-cholesterol treatment Vioxx.

The Journal reports that some Democrats said that if they increase their majority in Congress this election cycle they will propose bills to undo pre-emption and guarantee the ability of patients to sue for damages (Wall Street Journal, 10/27).

Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.

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View drug information on Vioxx; Zyprexa.