Summary of Wyeth v. Levine
Citation: 555 U.S. 555
Relevant Facts: Diane Levine intravenously injected Phenergan into her arm. The drug was manufactured by Wyeth, and used to prevent allergies and motion sickness. Complications from the injection of the drug resulted in Levine having to get her arm amputated. Ms. Levine sued Wyeth, claiming that the company had failed to provide a warning label indicating that arterial injuries could occur from improper injection of the drug. Wyeth claimed protection from suit on the grounds that the FDA found that their warnings were federally sufficient, even though they may have been deficient by state of Vermont standards. The Superior Court of Vermont sided with Ms. Levine and denied Wyeth’s petition for a new trial. The Supreme Court of Vermont affirmed the ruling on Wyeth’s appeal and held that FDA standards represent a bare minimum, not a maximum threshold. States could in effect make more stringent regulations against companies.
Issues: The legal question presented was whether federal law preempts state law with respect to personal injury lawsuits against drug manufacturers that fail to provide more labeling for state standards than is expected for the federal level.
Holding: The Supreme Court held that no, federal law does not preempt state law in such cases.
Reasoning: The Supreme Court reasoned that although the FDA indicated that its labeling for Phenergan was sufficient for federal purposes, Wyeth ultimately always was responsible for the content of its labels. The Court also reasoned that Congress’ entrusting of the FDA to make federal decisions about food and drug safety standards did not have anything to do with additional standards imposed by states.
Dissent: Justices Alito, Roberts and Scalia dissented, arguing that because of the nature of personal injury cases in which juries are the fact finders and provide verdicts, the fact that Wyeth was subject to regulation by jurors – lay people – was absurd. Additionally, although states could have their own regulations of drug manufacturer’s products, it was problematic for such regulation to be determined by juries rather than administrative or otherwise bureaucratic agencies such as the FDA.