Wyeth v. Levine

Levine (plaintiff) lost part of her forearm to gangrene after Wyeth's (defendant) drug Phenergan was improperly injected into an artery rather than a vein during treatment for a migraine. She sued Wyeth under Vermont negligence and strict-liability law, arguing the drug's warning label inadequately conveyed the serious risk of arterial exposure, even though the FDA had approved that label. FDA regulations separately allow manufacturers to add to or strengthen a label without prior FDA approval. Levine won at trial and on appeal, and Wyeth argued before the Supreme Court that her state-law claims were preempted by federal drug regulation.

Whether state tort-law products-liability claims for failure to warn are preempted by federal law.