Tragic Facts Make Bad Law: Court Rejects Expert View on Drug Labels
Andrew M. Grossman /
The decision in the blockbuster case of Wyeth v. Levine is just out, and Lyle Dennison’s early commentary is here.
To summarize: In an opinion by Stevens, joined by Kennedy, Souter, Ginsburg, and Breyer, the Court held that FDA approval of a drug’s labeling does not preempt state-law failure-to-warn claims. The plaintiff, Diana Levine, developed gangrene after her arm was injected with Phenergan, a drug manufactured by the defendant, Wyeth. Levine sued in Vermont state court, claiming that Wyeth had failed to provide adequate warning about the risks of the method by which the drug was administered, and the jury awarded damages. Wyeth appealed, arguing that the Food, Drug, and Cosmetics Act, as well as FDA regulations requiring FDA approval of drug labels, preempted the state-law claim, providing a complete defense to it. The Court today rejected that argument.
After reading the opinion, and refamiliarizing myself with the facts and law of the case, I share Alito’s view: “This case illustrates,” his dissenting opinion begins, “that tragic facts make bad law.”