The U.S. Supreme Court recently held, in Wyeth v. Levine, that a state-law products liability claim was not preempted by FDA approval for the marketing of a drug and its label. The drug in question, Phenergan, is used to treat nausea and is administered intravenously. If Phenergan inadvertently enters a patient’s artery, rather than a vein, it causes irreversible gangrene. After suffering such gangrene and subsequent amputation of her hand resulting from such an injection, Diane Levine sued Wyeth relying on common law negligence and strict liability theories, alleging that the labeling of the drug was defective because, although it warned of the danger of gangrene, it failed to instruct clinicians not to use the IV-push method of administration. Wyeth argued that Levine’s claims were preempted by federal law because the drug’s label had been approved by the FDA.
Justice Stevens, writing for a 6-3 majority, found no direct conflict between state and federal law that would make it impossible to both comply with FDA labeling requirements and strengthen the Phenergan warnings. The mere fact that the FDA had approved Phenergan’s label did not establish that it would have prohibited a change strengthening the warnings. Because the FDA had not considered and rejected stronger warnings regarding the dangers of IV-push administration, Wyeth could have unilaterally strengthened those warnings. Neither would complying with state law obstruct the purpose of federal drug-labeling regulation. The failure of Congress to provide a federal remedy for consumers harmed by unsafe drugs indicated that it determined that state-law actions provided appropriate relief. The court also noted that manufacturers have access to information superior to that of the FDA regarding the risks of their drugs. State tort suits uncover unknown hazards and provide incentives for manufacturers to disclose safety risks promptly.