SW Legal studies in Business

FDA Labeling Regulation Does Not Preempt State Law Product Liability Claim

Supreme Court held that the state-court product liability judgment against a drug maker for inadequate warning of dangers associated with injecting a drug was not precluded by the requirement that the drug maker obtain FDA approval for drug warnings.


Consumer Protection

Key Words

FDA; Warning; Failure to Warn; Liability; Preemption

C A S E   S U M M A R Y

Wyeth makes an anti-nausea drug, Phenergan. Levine was injected with the drug. Her arm developed gangrene and had to be amputated. Levine sued Wyeth in state court in Vermont, claiming that Wyeth failed to provide adequate warnings about the risks of administering Phenergan directly into a vein. The jury found that the injury would not have occurred if there had been proper warning of the dangers of injection. Levine was awarded damages. The Vermont high court upheld the judgment. Wyeth appealed to the Supreme Court, contending that the failure-to-warn claim was pre-empted by federal law because the label on the drug had been approved by the Food and Drug Administration (FDA).


Affirmed. The claim that Wyeth cannot comply both with state-law duties under product liability and federal labeling duties is rejected. Although a maker may change a drug label only after the FDA approves a supplemental application by the maker, the agency permits certain preapproval labeling changes that add or strengthen a warning to improve drug safety. Wyeth could have added a stronger warning about injections, and there is no evidence that the FDA would have rejected such a change in the label. Further, there is no evidence that Congress intended to pre-empt state law failure-to-warn actions by having the FDA regulate drug warning labels. State law is a complementary form of drug regulation.


Wyeth v. Levine, 129 S.Ct. 1187 (Sup. Ct., 2009)

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