The Supreme Court handed down its decision this morning in the Wyeth v. Levine federal preemption case, holding, by a 6-3 majority, that “Federal law does not pre-empt [plaintiff Diana] Levine’s claim that [the Wyeth drug] Phenergan’s label did not contain an adequate warning about the IV-push method of administration.” Justice Stevens wrote the majority opinion, joined by Justices Kennedy, Souter, Ginsburg, and Breyr, and with Justice Thomas concurring in the judgment. Justice Alito wrote a compelling dissenting opinion, joined by…

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The Wyeth v. Levine case presents a narrow set of facts in which the Food and Drug Administration had, for many years, known about the risks presented by intravenous push injection of Phenergan and worked with the manufacturer to carefully word the label description of this risk. There is no allegation of fraud in this case, nor has relevant information about this risk arisen since the label language was last amended. Nevertheless, disregarding the limiting facts in the Levine case, a flood of…

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The Supreme Court’s pending, and perhaps imminent, decision on the preemptive effective of FDA drug labeling approvals in Wyeth v. Levine has stimulated a flood of legal and public policy debate on the roles that federal regulation and state-law based tort litigation should play in regulating pharmaceutical manufacturers. That debate, which is almost certain to continue in a legislative forum should Wyeth prevail before the Court, may determine the future of the now-lucrative litigation industry. More importantly, arguments made in the debate by…

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Back in November, I wrote about the pending Supreme Court case Wyeth v. Levine, the decision in which will have a huge impact on the pharmaceutical industry and the law of federal preemption. The plaintiff in that case, Diana Levine, was injured when a physician’s assistant improperly injected a Wyeth-made drug into Levine’s artery despite a clear, FDA-approved label statement warning against possible risks from arterial injection.

Levine and her lawyers were nevertheless able to convince a Vermont jury that FDA’s…

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Diana Levine suffered from chronic migraine headaches for many years. So, in April 2000, when she went to a local clinic to get treatment, she knew what to expect. She’d received the same treatment several times before: an injection of Demerol for the pain, and an injection of an antihistamine called Phenergan to treat the nausea that accompanies both migraine headaches and Demerol itself. Everything was normal — except for how the drugs were actually administered. The physician’s assistant who gave…

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