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Wyeth v. Levine: U.S. Supreme Court Rules FDA Approval of Label Does Not Provide Pharmaceutical Manufacturer with Complete Preemption Defense to State Failure-to-Warn Claims

Mar.04.2009

In Wyeth v. Levine, the Plaintiff Diana Levine claimed she was injured by the inappropriate administration of Wyeth's prescription drug Phenergan. A Vermont jury concluded the Phenergan label should have more strongly warned physicians against IV-push administration because of the known risk of intra-arterial injection and consequent development of gangrene. On appeal, Wyeth argued that Levine's suit was preempted because the U.S. Food and Drug Administration (FDA) approved the Phenergan label. Today, the United States Supreme Court held 6-3 that federal law did not preempt Levine's claim because it was possible for Wyeth to comply with federal and state law. Wyeth v. Levine (No. 06–1249)

In its opinion, the Court rejected Wyeth's principal argument that Levine's state law claims were preempted because it was impossible for Wyeth to comply with both the state law duties underlying those claims and federal labeling requirements. The Court explained that Wyeth could have unilaterally added a stronger warning because there was no evidence that the FDA would have rejected it. The Court found that although a manufacturer generally needs supplemental FDA approval to change a drug label, the agency's "changes being effected" regulation permitted certain label changes to add or strengthen a drug safety warning.

The Court also found no merit to Wyeth's other argument that requiring it to comply with a state law duty to provide a stronger warning would interfere with Congress's goal of entrusting the FDA with drug labeling decisions. In support of its position, Wyeth relied on the FDA's 2006 Physician Labeling Rule, which sets forth new regulations governing the content and format of prescription information for human drugs and biologics. Included in the preamble to the rule was the statement that the agency believed that its approval of a drug label preempted conflicting or contrary state law. However, the Court took issue with what it characterized as Wyeth's "untenable interpretation of Congressional intent and an overbroad view of an agency's power to preempt state law." The Court reasoned that the preamble did not merit any deference because FDA had failed to provide the public with an opportunity to comment on the preemption question; the preamble language ran contrary to the available evidence of Congress's purpose and reversed -- without explanation -- FDA's longstanding position that state law was a complementary form of drug regulation. The Court concluded that the history of the Food Drug and Cosmetic Act (FDCA) illustrates that Congress never intended to preempt state law failure-to-warn actions and noted further that the central premise of the FDCA and FDA's regulations was that "the manufacturer bears responsibility for the content of its label at all times." For further analysis of the preamble preemption issue, see "Supreme Court Asked To Consider Congressional Staff Report on Eve of Oral Argument in Wyeth v. Levine," Crowell & Moring Life Sciences & Torts Alert (November 5, 2008).

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