In a highly anticipated case decided on Wednesday, March 4, 2009, the United States Supreme Court held that the Food and Drug Administration’s (“FDA”) approval of prescription drug labeling for Wyeth’s anti-nausea drug, Phenergan, did not pre-empt state law failure-to-warn claims or provide Wyeth with a complete defense to Levine’s tort claims that Phenergan’s label should have contained stronger warnings against the IV-push method of administration. Wyeth v Levine, 2009 WL 529172 (U.S. 2009).
With Justice Stevens writing for the majority, the Court rejected Wyeth’s “impossibility pre-emption” defense that the company could not simultaneously comply with FDA labeling regulations while satisfying a standard of care imposed by state law. The Court found that Wyeth could have strengthened its warnings about the risks associated with IV-push administration of Phenergan via the “changes being effected” (“CBE”) regulation. By revising the labeling to reflect “newly acquired information” about Phenergan, including “new analyses of previously submitted data” under the CBE regulation, Wyeth could have augmented the warning without rendering Phenergan a “new drug” or “misbranded drug.” Absent clear evidence that the FDA would not have approved a change to Phenergan’s label, the Court declined to find impossibility of compliance with both federal and state requirements.
The Court also rejected Wyeth’s argument that Levine’s state tort action was an unacceptable “obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Unlike the medical device manufacturer in Riegel v. Medtronic, Inc., — U.S. —, 128 S.Ct. 999 (2008) (analyzing pre-emption under the Medical Device Amendment), Wyeth could not point to express pre-emption language in the Food Drug and Cosmetic Act (“FDCA”). The absence of an express pre-emption clause in the FDCA was “powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness” or perceive state courts as obstacles to the FDA’s mission. According to Justice Stevens, “[i]f Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express pre-emption provision at some point during the FDCA’s 70-year history.”
Justice Stevens gave no credence or deference to Wyeth’s contention that the FDA’s preamble to a 2006 regulation for drug labels pre-empted Levine’s claims. Instead, the Court determined that the FDA’s 2006 preamble was not a regulation and not entitled to the same recognition as the Federal Motor Vehicle Safety Standards at issue in Geier v. American Honda Motor Co., 529 U.S. 861 (2000). Indeed, Justice Stevens declined to recognize the validity of the pre-emption language in the FDA’s 2006 preamble due to the agency’s “procedural failure” in finalizing the rule with a new, sweeping preamble “without offering States or other interested parties notice or opportunity for comment.”
Justices Breyer and Thomas each wrote separate concurring opinions. Justice Alito wrote a dissenting opinion, in which Justice Scalia and Chief Justice Roberts joined.
This landmark pre-emption decision promises to have a complicated and long-lasting impact in all branches of government. We look forward to analyzing Levine’s impact in greater depth in future installments.
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