SZD Health Law Scan : Health Care Lawyers & Attorneys : Schottenstein Zox & Dunn Law Firm : Strategic Planning, Managed Care, Insurance : Columbus, Cleveland, Cincinnati, Central Ohio

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On March 4, 2009, in Wyeth v. Levine, No. 06-1249, the United States Supreme Court upheld, by a 6-3 vote, the Vermont Supreme Court's holding in favor of a patient who argued that the Food and Drug Administration's (FDA) approval of a pharmaceutical drug's label warnings did not impliedly preempt state failure-to-warn claims.

The Plaintiff, Diana Levine, sued Wyeth, the manufacturer of a drug that a physician's assistant had incorrectly administered causing gangrene to develop in her arm. While the drug's label contained warnings about certain techniques related to the methods of administration, the physician's assistant had used an FDA-approved method. Levine asserted state failure-to-warn claims arguing that the FDA-approved label warnings inadequately warned about the dangers associated with the particular method the physician's assistant had used. A Vermont state court denied Wyeth's motion for summary judgment asserting that federal law preempted the state law claims, and a jury found for Levine. After the Vermont Supreme Court affirmed, the United States Supreme Court granted Wyeth's petition for certiorari.

Writing for the majority, Justice John Paul Stevens rejected Wyeth's two major arguments. Wyeth first argued that the state claims were preempted because it was impossible for a drug manufacturer to comply with both the state law and the federal labeling duties. Wyeth claimed that only the FDA could change the labels. However, Stevens concluded that the "changes being effected" (CBE) regulation provided Wyeth with the means to satisfy both the state and federal duties because the CBE regulations permitted Wyeth to unilaterally add a stronger warning about IV-push administration without prior FDA approval.

Wyeth also argued that compliance with a state-law duty to provide a stronger warning about IV-push administration would obstruct the purposes and objectives of federal drug labeling regulation, which Wyeth unsuccessfully argued, was to leave such decisions to the FDA, an "expert agency." However, Stevens focused on the lack of a federal remedy for consumers harmed by inadequate warnings and the lack of an express preemption provision. He then concluded, "Evidently, [Congress] determined that widely available state rights of action provided appropriate relief for injured consumers."

In rejecting Wyeth's second argument, Stevens dismissed similar Bush Administration arguments from the FDA and the Department of Justice (DOJ). In addressing the FDA's claim of preemption in its 2006 preamble, which the Court saw as "revers[ing] the FDA's own longstanding position, Stevens wrote that the claim "does not merit deference" because it lacked "thoroughness, consistency, and persuasiveness." Likewise, in a footnote, Stevens dismissed the DOJ's amicus brief as "similarly undeserving of deference." Instead, he deferred to tradition: "it appears that the FDA traditionally regarded state law as a complementary form of drug regulation."

Writing for the dissent, Justice Samuel Alito argued that juries are "ill-equipped" to perform the FDA's role in deciding whether a prescription drug's label is adequate. Additionally, while Alito also did not defer to the FDA's 2006 preamble, he did defer to the FDA's labeling decisions. He argued that the only relevant question was whether the "State had upset the regulatory balance struck by the federal agency." As precedent for this proposition, Alito looked to the Court's decision in Geier v. American Honda Motor Co., 529 U. S. 861 (2000), which he concluded "compels" the preemption of state law in the present case. There, the Department of Transportation (DOT) had permitted car manufacturers to choose from a "menu" of passive restraints in cars. As a result, a plaintiff's state law claim against a car manufacturer for not choosing a certain passive restraint was preempted because it would upset the balance of DOT's regulatory scheme. Alito analogized this menu of passive restraints to the drug label's options for methods of administration. As in Geier, where DOT concluded that the menu options were safe, so too the FDA had decided, through its labeling decisions, that the drug label's options were safe and Levine's state law claims should be preempted.