## Facts

- Diana Levine, a professional musician, was treated for migraine-related nausea at a Vermont clinic and was administered Phenergan, an anti-nausea drug manufactured by Wyeth.
- Phenergan was given by “IV-push” (direct injection into a vein); the drug is corrosive and can cause gangrene if it enters an artery.
- The drug entered an artery, Levine developed gangrene, and her forearm was amputated.
- Levine settled separate malpractice claims against the treating health-care providers and sued Wyeth in Vermont state court for negligence and strict liability based on failure to provide an adequate warning about IV-push administration.
- A jury found Levine’s injury would not have occurred with an adequate warning and awarded damages for pain and suffering, medical expenses, and loss of livelihood.
- Wyeth argued the claims were preempted because the FDA had approved Phenergan’s labeling; the trial court rejected preemption, and the Vermont Supreme Court affirmed.

## Issues

1. Whether federal drug-labeling law preempted state-law failure-to-warn claims concerning risks of IV-push administration where the FDA had approved the drug’s label.
2. Whether it was impossible for Wyeth to comply with both federal labeling requirements and state tort duties because label changes required FDA approval.
3. Whether state tort liability posed an obstacle to Congress’s objectives in assigning labeling oversight to the FDA.

## Decision

- The Supreme Court affirmed (6–3) and held that federal law did not preempt Levine’s state-law failure-to-warn claims.
- The Court rejected impossibility preemption because federal regulations allowed certain unilateral label changes to strengthen warnings (the “changes being effected” regulation), and Wyeth did not show the FDA would have rejected a stronger warning.
- The Court rejected obstacle preemption, finding no congressional intent in the FDCA to displace traditional state tort remedies and treating state failure-to-warn suits as consistent with federal drug-safety aims.
- The Court emphasized that manufacturers, not the FDA, bear primary and continuing responsibility for the adequacy of drug labeling.

## Legal Principles

- FDA approval of a prescription drug label does not, by itself, preempt state-law failure-to-warn claims.
- Impossibility preemption requires a showing that the manufacturer could not comply with both federal and state duties; the availability of a federal mechanism to strengthen warnings can defeat that showing.
- Obstacle preemption requires evidence that state law stands as a barrier to congressional objectives; absent a clear congressional command, traditional state tort remedies may operate alongside federal regulation.
- Under the FDCA and FDA regulations, the manufacturer retains ongoing responsibility for label content and may have authority to strengthen warnings to improve safety.

## Conclusion

The Court held that Levine’s failure-to-warn verdict was not preempted because federal labeling law left manufacturers responsible for warning adequacy and permitted strengthened warnings without prior FDA approval, and Congress did not indicate that FDA regulation displaced state tort remedies.


Wyeth v. Levine, 555 U.S. 555 (2009)