Products Liability - Pharmaceuticals

This past March, the U.S. Supreme Court extended the liability of drug makers by deciding that a U.S. Food and Drug Administration ("FDA") approved warning does not shield a manufacturer from liability in failure to warn actions, Wyeth v. Levine (March 4, 2009). Plaintiff was injected with a nausea drug manufactured by the defendant. When that drug came into contact with her artery, she developed irreversible gangrene and had her arm amputated. Plaintiff brought her case against the drug manufacturer claiming that although the drug included a warning regarding the risk of developing gangrene, that warning was insufficient.

Defendant argued that complying with individual state requirements on warnings would contradict FDA label requirements. In addition, the defense claimed that allowing state courts to rule on FDA approved warnings contradicts the FDA's national objectives, ignoring their expert opinions. In the end, the Supreme Court disagreed on both counts and decided that an FDA approved warning does not preempt additional state requirements. This has already opened the door to products liability actions against pharmaceutical companies which were previously believed to be preempted by the FDA's approval. The Supreme Court has already remanded several cases down to lower courts for further proceedings consistent with the Wyeth decision.





























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