In the News

Supreme Court's Decision in Wyeth Limits Implied Preemption Defense

Mar 12, 2009

The U.S. Supreme Court struck down an attempt to nullify state tort laws as they apply to prescription drug products in its March 4, 2009 decision in Wyeth v. Levine (555 U.S___, No. 06-1249). The Court was presented with the issue of whether approval of a prescription drug label by the U.S. Food and Drug Administration (FDA) provides a drug manufacturer with a complete defense to a civil tort claim being tried to a jury. The Court held (6-3) that it did not and, although the Court's ruling arguably did not dramatically alter the landscape of federal preemption law as many expected it would, the decision signals a move towards limiting the availability of the implied preemption defense.

By way of background, in April 2000, Diana Levine went to her health clinic for treatment of nausea and other symptoms relating to severe migraine headaches. To control her symptoms, the treating clinicians gave her Phenergan, an anti-nausea drug manufactured by Wyeth. The drug was administered by an "IV-push" method. One of the risks associated with the IV-push method, as disclosed on the FDA approved label, is that it could lead to rapid onset of gangrene if the drug makes its way into an artery instead of a vein. This is exactly what happened in Levine's case, resulting in the loss of her forearm.

Levine sued Wyeth in Vermont state court for monetary damages, alleging that Wyeth failed to adequately warn about the dangers of administering the drug through the IV-push method. The Vermont trial judge denied Wyeth's assertion that Levine's claim was preempted by federal approval of the drug's label, stating that FDA's approval of Wyeth's label did not prevent the manufacturer from adding to or strengthening warnings on the label. A jury awarded Levine millions in damages. The decision was affirmed by the Supreme Court of Vermont and the Supreme Court granted certiorari. FDA, alongside Wyeth, argued that federal drug-approval and warning-label standards should preempt stricter state laws in the form of tort liability.

The Majority Opinion

Justice Stevens, writing for the majority, which included Justices Kennedy, Souter, Ginsberg, Breyer, and Thomas, held that FDA approval of drug labeling does not preempt state laws or shield companies from legal damages arising from liability claims. In deciding against the application of the preemption doctrine, the majority began its analysis by indicating that the police powers of the states with respect to drug labeling are not preempted by federal law unless that was the purpose of Congress. Justice Stevens' opinion traced the long history of FDA regulations that worked alongside state law to assure the safety and effectiveness of drugs. The majority opinion emphasized that historically, the burden of ensuring label accuracy ultimately lies with drug manufacturers.

The majority then addressed, and rejected, each argument Wyeth set forth in favor of its position that preemption should bar Levine's state law failure to warn claims. First, Wyeth argued that it was impossible to comply with both federal and state requirements, where the former approved Wyeth's labeling related to the IV-push method, and the latter would have required a different label; and that Wyeth couldn't change the label without FDA's permission. The Court rejected these arguments, relying on FDA's recent "changes being effected' ("CBE") regulation, which permits a drug manufacturer to change a drug label to strengthen its warnings without prior approval from FDA.

Second, Wyeth argued that by penalizing drug companies for using FDA approved labeling, state law tort claims like Levine's would obstruct the purpose of the labeling regulations set forth by Congress in the Food Drug and Cosmetic Act ("FDCA") by allowing juries to second-guess the expert risk determinations of the FDA. Relying on historical evidence of the co-existence of FDA regulation of drug labeling and implicit congressional approval of state tort litigation in the area of drug labeling, the Court rejected Wyeth's arguments.

Finally, Wyeth argued that, notwithstanding the CBE regulation, a statement by FDA in the preamble to a 2006 regulation governing the format and content of prescription drug labels was enough to preempt Levine's claims. Specifically, the FDA preamble stated that "FDA approval of labeling . . . preempts conflicting or contrary State law" (71 Fed. Reg. 3922 (2006)). Significantly, the Court recognized that an agency regulation bearing the force of law could preempt conflicting state law requirements. However, in this case, the Court found that FDA's proclamations in a preamble to a regulation did not carry the force of law and, therefore, Levine's claims were not preempted by that language.

Dissent

Justice Alito wrote a dissenting opinion, which was joined by Chief Justice Roberts and Justice Scalia, that took issue with the majority's view that the Wyeth case presented a narrow issue for the Court to resolve, namely whether Wyeth had a duty to adequately warn against the risks associated with administration of Phenergan to patients via the "IV-push" method.

The dissent framed the issue in much broader terms. Specifically, whether a jury deciding a state tort claim should be empowered to overrule the considered judgment of the federal agency charged with making determinations about the adequacy of a drug's warning label. The dissenting Justices would have found Levine's claim to be preempted FDA's authority to regulate the form and content of drug labeling. The dissent suggested that such an out come was more in keeping with the Court's prior decisions.