U.S. Supreme Court Decision in Wyeth v. Levine -- No Pre-emption

By a vote of 6-3, the Supreme Court just ruled against Wyeth in a case in which the drug company had argued that compliance with FDA regulations resulted in pre-emption of civil suit claims brought against it by Levine, who was injured by Wyeth's Phenergan drug and had her forearm amputated. Click here for the Opinion.

The case turned on the concept of “pre-emption,” in which Wyeth argued that Federal regulations should trump state actions. Wyeth had argued that because the FDA regulated drugs, patients shouldn't be allowed to sue in state court when drug makers follow the rules established by the FDA. The case had broad implications for medical device manufacturers and others.

The court rejected that argument. “We conclude that it is not impossible for Wyeth to comply with its state and federal law obligations,” Justice Stevens wrote the majority opinion, which was joined by Kennedy, Souter, Ginsburg and Breyer. Justice Thomas wrote a concurring opinion, while Roberts, Alito and Scalia dissented.