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Wyeth v. Levine

Supreme Court of the United States · 2009 · Civil Procedure

Civil ProcedureConstitutional LawTortsfederal preemptiondrug labelingfailure to warnpreemptionconflict preemption

Facts

Levine lost her arm after Phenergan was administered intravenously by the IV-push method and the drug entered her artery, causing gangrene. Wyeth's label warned generally about gangrene and amputation from inadvertent intra-arterial injection, but did not specifically warn about the risks of IV-push administration or instruct clinicians to use the lower-risk IV-drip method instead. Levine sued Wyeth under Vermont common-law negligence and strict-liability theories, alleging inadequate warnings. The trial evidence showed that the risk of arterial exposure could be almost entirely eliminated by IV-drip use and that Wyeth could have strengthened its warning under FDA regulations without prior approval.

Issue

Does federal law preempt a state-law failure-to-warn claim against a drug manufacturer when the FDA had approved the drug's label? More specifically, was it impossible for Wyeth to comply with both federal labeling law and the state-law duty found by the Vermont jury, or did the tort claim obstruct the purposes and objectives of Congress under the FDCA?

Rule

State-law failure-to-warn claims against prescription drug manufacturers are not preempted merely because the FDA approved the drug's label. Impossibility preemption requires clear evidence that the FDA would not have approved the stronger warning, and where the CBE regulation permitted the manufacturer to unilaterally strengthen the warning, compliance with both federal and state law is not impossible. Nor are such claims obstacle-preempted where Congress did not make FDA oversight the exclusive means of ensuring drug safety and the agency's contrary preemption assertions lack persuasive weight.

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One of 10 multiple-choice questions for this case. Pick an answer to see why.

In Portland, Maine, Nora Ellis sued North Harbor Therapeutics after her doctor administered its anti-seizure drug by a labeled route that carried a known but underemphasized risk of permanent nerve damage. At trial, Nora showed that FDA regulations allowed the manufacturer to add or strengthen a warning or administration instruction through the CBE process without prior FDA approval, and the company had never asked the FDA to approve a stronger warning.

North Harbor argues the claim is preempted because the FDA had approved the drug's label years earlier. What is the strongest response?

Explanation. The majority held that FDA approval of a label does not by itself preempt a state failure-to-warn claim. Impossibility is a demanding defense. Where the CBE regulation permits the manufacturer to add or strengthen warnings or administration instructions to increase safe use, the manufacturer can comply with state law unless there is clear evidence the FDA would not have approved the stronger warning.