Wyeth v. Levine
Citation: 555 U.S. 555 (2009) Court: Supreme Court of the United States
Facts
Diana Levine, a professional musician, received Phenergan (promethazine) via the IV-push method and developed gangrene, resulting in the amputation of her forearm. She sued Wyeth under Vermont state tort law, alleging failure to warn of the risks associated with IV-push administration. Wyeth defended on the grounds that FDA approval of its label preempted Levine’s state failure-to-warn claim. The Vermont Supreme Court ruled for Levine; the U.S. Supreme Court granted certiorari.
Issue
Whether FDA approval of a drug label preempts a state law failure-to-warn tort claim under the doctrine of implied impossibility preemption.
Holding
The Supreme Court (6-3) held that FDA approval did not preempt Levine’s state tort claim. Because Wyeth could have unilaterally strengthened its warning label under the FDA’s “changes being effected” (CBE) regulation without prior FDA approval, it was not impossible to comply with both federal requirements and a more stringent state duty to warn.
Rule / Doctrine
Impossibility preemption requires an actual, irreconcilable conflict between federal and state law. FDA approval of a drug label does not automatically preempt stricter state failure-to-warn standards because manufacturers retain the ability to strengthen warnings unilaterally through the CBE process. The presumption against preemption is especially strong in areas of traditional state police power such as tort law. Congress’s silence on preemption in the FDCA, combined with the FDA’s longstanding coexistence with state tort suits, counsels against finding implied preemption.
Significance
Wyeth v. Levine is the leading modern case on impossibility preemption in the pharmaceutical context. It reaffirms a robust role for state tort law as a complement to federal drug regulation and is contrasted with Geier v. American Honda Motor Co. (where conflict/obstacle preemption was found). The case also sparked significant debate about the role of agency preambles and regulatory preambles as evidence of congressional preemptive intent.