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United States: Federal Approval of Drug Label Does Not Preempt State Failure-to-Warn Claim

(Mar. 16, 2009) On March 4, 2009, the Supreme Court ruled that the U.S. Food and Drug Administration's (FDA) approval of a drug's labeling does not preempt a state duty-to-warn tort claim.

Diana Levine, a professional musician, had Phenergan, an antihistamine manufactured by Wyeth, administered to her by the “IV-push” method. The drug entered an artery, leading to gangrene and the amputation of her forearm. Levine sued Wyeth in Vermont state court, alleging that Wyeth failed to provide an adequate warning about the significant risks of administering Phenergan by the IV-push method compared with safer methods. The jury agreed that Phenergan's labeling was inadequate and that it caused Levine's injury. The trial court, and on appeal the Vermont Supreme Court, rejected Wyeth's arguments that because the FDA had approved Wyeth's labeling, federal law preempted state law failure-to-warn claims. The Supreme Court granted Wyeth's petition to hear the case.

The Supreme Court ruled that Levine's state law claim based on Phenergan's inadequate labeling was not preempted by federal law. The Court rejected Wyeth's claim that it was impossible to comply with both federal and state law duties, observing that FDA regulations permit drug manufacturers to strengthen their warning labels to improve drug safety subsequent to FDA approval, and that therefore Wyeth could have warned doctors not to administer the drug by the IV-push method as it learned of that method's dangers. The Court emphasized that under federal law, the manufacturer, not the FDA, bears responsibility for the content of a drug's label at all times.

The Court also rejected Wyeth's argument that requiring drug manufacturers to comply with a state law duty to comply with a stronger warning than the label approved by the FDA would interfere with Congress's purpose of entrusting the FDA with drug labeling decisions. The Court found that Congress repeatedly declined to legislatively preempt state failure-to-warn actions for drugs. Wyeth sought to rely on a 2006 FDA statement in a regulation's preamble that state failure-to-warn claims interfere with the FDA's statutorily prescribed role, but the Court said the agency's assertion, which dramatically conflicted with the FDA's longstanding position that state law complements FDA regulation, was “inherently suspect” and entitled to no weight. (Wyeth v. Levine, No. 06-1249 (Mar. 4, 2009), available at