March 5, 2009  

Written by Attorneys: John F. Mullen Sr. and Darren L. Harrison

Note: This article is an interpretation of current law and is offered for informational purposes only. This material is not legal advice and should not be construed or used as a substitute for the advice of an attorney.

In a case that will significantly impact (and likely increase) medical product/pharmaceutical litigation, on March 4, 2009, the United States Supreme Court held that labeling approval by the Food and Drug Administration (FDA) does not preempt state laws or shield companies from legal damages as part of liability claims.

In Wyeth v. Levine, --- S. Ct. ----, 2009 WL 529172 (U.S. March 4, 2009), Diana Levine, a guitarist, had part of her arm amputated after an intravenous injection of an anti-nausea drug manufactured by Wyeth resulted in gangrene of the forearm. Levine sued Wyeth in Vermont state court and the jury awarded her $7 million dollars. Wyeth appealed and the Vermont Supreme Court upheld the award, rejecting Wyeth's argument that labeling approvals by the FDA preempts state law liability claims.

In a 6-3 opinion authored by Justice Stevens, the United States Supreme Court held that the burden of ensuring label accuracy should lie in the hands of manufacturers, not with the FDA.

Wyeth argued before the United States Supreme Court that because it could not change the label without FDA permission, it would be impossible to avoid the negligence for which the jury found liability. Justice Stevens disagreed with Wyeth's federal regulations arguments and stated that Wyeth had the ability, if it so desired, to strengthen the warning label before seeking retroactive FDA approval. Justice Stevens further concluded that it is "a central premise of federal drug regulation" that "the manufacturer bears responsibility for the content of its label at all times."

Wyeth also argued that concurrent state liability would frustrate the rationale behind federal regulation, which is to put labeling decisions in the hands of an expert agency. Justice Stevens disagreed and stated that such an argument was based on "an untenable interpretation of congressional intent and an overbroad view of an agency's power to preempt state law."

Importantly, while Wyeth is sure to be cited by plaintiffs in future litigation, this Supreme Court decision has not resulted in a new doctrine intended to make sweeping changes on preemption of state tort laws. Rather, a court must still analyze the statutory scheme of any statute under scrutiny and decide whether or not state action is incompatible with federal law. If the state action is not clearly incompatible with federal law, Wyeth supports plaintiffs' right to proceed with lawsuits in state court. Although plaintiffs will celebrate Wyeth as a victory for those harmed by allegedly deficient warning labels, the true impact of this decision remains to be seen.