Supreme Court Holds that FDA Regulation Does Not Preempt State Tort Claim
By Caitlyn Ross – Edited by Miriam Weiler
Wyeth v. Levine
Supreme Court of the United States, March 4, 2009, No. 06-1249
On March 4th, the Supreme Court of the United States affirmed the judgment of the Vermont Supreme Court, holding that federal drug labeling regulations do not preempt state failure-to-warn lawsuits. The Supreme Court held that compliance with FDA labeling requirements did not preempt Levine’s failure-to-warn claim based on what she alleged was defective labeling of Wyeth’s anti-nausea drug Phenergan. In so holding, the Court concluded that Congress did not intend to preempt state-law failure-to-warn actions. It also rejected Wyeth’s claim that the Court should defer to an FDA statement, made in the preamble to a 2006 regulation, that state tort suits threatened the FDA’s statutory mandate.
Briefs and relevant court documents are available here at the SCOTUS wiki. The SCOTUS Blog provides an overview of the case. Drug and Device Law Blog suggests that the decision does not eliminate preemption alcims, but does make them far more difficult to win. The Wall Street Journal Law Blog features an analysis of the decision. The Volokh Conspiracy notes a decrease in deference to agencies.
The Court upheld a $6.7 million jury award to musician Diana Levine, who lost most of her right arm to gangrene after an IV-push injection of Wyeth’s anti-nausea medication Phenergan. Levine settled her claims against the health center and clinician who administered the Phenergan. She then sued Wyeth in state court, arguing that the pharmaceutical company should have revised its FDA-approved label to warn clinicians not to use the higher-risk IV-push method of injection for administering the drug. A jury ruled in Levine’s favor, determining that Wyeth was negligent and Phenergan was a defective product as a result of inadequate warnings and instructions. On appeal, the Vermont Supreme Court affirmed, holding that the jury’s verdict was not preempted by federal labeling requirements because Wyeth could have warned against IV-push administration without prior FDA approval, and because federal labeling requirements create a floor, not a ceiling, for state regulation.
Justice Stevens wrote the majority opinion, joined by Justices Kennedy, Souter, Ginsburg and Breyer. The majority reasoned that drug companies remain primarily responsible for keeping their warning labels up to date and complete despite federal labeling requirements. It also concluded that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.
Based on a statement made in the preamble of a 2006 FDA regulation, Wyeth had argued that the FDA’s statutorily prescribed role as an expert federal agency responsible for evaluating and regulating drugs preempted conflicting state requirements. The majority acknowledged that agency regulation with the force of law can preempt conflicting state requirements, but it maintained that in each case the Court would perform its own analysis of the substance of state and federal law and not rely on agency proclamations of preemption. The majority concluded that the FDA’s statement that state law frustrated the agency’s implementation of its statutory mandate did not merit deference. Based on its reading of the regulatory history and background, the majority concluded that there was a longstanding coexistence of state and federal law and the FDA’s traditional recognition of state-law remedies was in place each time the agency reviewed Wyeth’s Phenergan label.
Justice Breyer concurred, emphasizing the narrow reach of the holding and clarifying that the FDA may still promulgate lawful specific regulations with preemptive effect. Justice Thomas wrote a separate concurrence supporting the majority’s conclusion but not its reasoning. Thomas expressed his skepticism of the Court’s current preemption doctrine, arguing that it lead to expansion of federal statutes and unconstitutional results. He would only preempt state law where Congress explicitly provided for such preemption.
Justice Alito dissented, joined by Justice Scalia and Chief Justice Roberts. Alito argued that the FDA was ultimately responsible for regulating warning labels for prescription drugs. He would not have disturbed the FDA’s judgment that the approved label was sufficient to render the use of Phenergan safe. Arguing that the FDA is better suited than juries to consider the interests of all potential users of a drug over a long period, Scalia emphasized that state tort law could not be used to impose a different labeling requirement than that required under federal law. Because a jury’s cost-benefit analysis in a single case could differ from that of the FDA’s, Scalia expressed concern that juries in all fifty states could contradict the FDA’s expert determinations, reducing the incentives for medical manufacturers to develop new medical products.