• Wyeth v. Levine: Is Federal Preemption of State-Law Failure-to-Warn Claims Dead?
  • April 3, 2009 | Authors: Chester Crews Townsend; Jeffrey Zager
  • Law Firms: Miller & Martin PLLC - Chattanooga Office ; Miller & Martin PLLC - Nashville Office
  • The short answer is that, at best, federal preemption of state-law failure-to-warn claims regarding drug labeling is on life support and not expected to survive.  Absent prior FDA rejection of a label warning, or clear evidence that the FDA would reject a proposed warning, a state-law failure-to-warn claim will not be preempted.

    On March 4, 2009, the U.S. Supreme Court rendered its decision in the closely watched Wyeth v. Levine. The Court held that plaintiff Diana Levine's state-law failure-to-warn claims are not pre-empted by the judgment of the FDA with respect to the prescription drug label at issue. The Court summarized the issue before it as whether the FDA's prior approval of a drug label provides a complete defense to state-law failure-to-warn tort claims. The Court answered No. In doing so, the Court declined to give any deference to a 2006 FDA regulatory pre-amble which strongly expressed a contrary agency view.

    Levine, after settling with her health care providers, filed suit against Wyeth seeking damages for the amputation of her forearm. The amputation was necessitated by complications from the administration of Wyeth's prescription drug Phenergan by the IV-push method. This method posed an enhanced risk of arterial damage. The FDA-approved label warned of the risk of gangrene and amputation following inadvertent intra-arterial injection, but did not instruct health care providers to use the IV-drip method of administration rather than the higher-risk IV-push method.

    After rejecting Wyeth's pre-emption based motion for summary judgment, the trial court instructed the jury that it could consider Wyeth's compliance with FDA labeling requirements but that such compliance did not establish that the warnings were adequate. The trial court further instructed, with no objection from Wyeth, that FDA regulations permit a drug manufacturer to change a product label to add or strengthen a warning prior to FDA approval of such change as long as the manufacturer later submits the revised warning for FDA review and approval. The jury found Wyeth negligent and found that Phenergan was rendered a defective product as a result of inadequate label warnings and instructions regarding the IV-push method of administration. The jury awarded Levine $7.4 million. The U.S. Supreme Court refused to reverse, rejecting Wyeth's argument that FDA approval of the subject label served to pre-empt Levine's state-law failure-to-warn claims.

    The Supreme Court's decision in Wyeth v. Levine sounds a death knell for federal pre-emption of state-law failure-to-warn claims based on FDA prescription drug label approval. Absent prior FDA rejection of a label change, or clear evidence that the FDA would reject a label change, federal law will not preempt a state law failure-to-warn claim.