Wyeth v. Levine (2008)
- Docket
- 06-1249
- Decided
- 2008-01-01
Summary
Question: Does federal law preempt state law in a personal injury action against a drug manufacturer for failing to include an appropriate warning label where the drug in question met the labeling requirements of the Food and Drug Administration? Conclusion: No. The Supreme Court affirmed the Supreme Court of Vermont holding that federal law did not preempt Ms. Levine's state-law claim that Wyeth's labeling of Phenergan failed to warn of the dangers of its intravenous administration. With Justice John Paul Stevens writing for the majority and joined by Justice Anthony M. Kennedy, Justice David H. Souter, Justice Ruth Bader Ginsburg, and Justice Stephen G. Breyer, the Court first rejected Wyeth's argument that by unilaterally changing its labeling of Phenergan, it would have violated federal labeling regulations. Rather, the Court asserted that the manufacturer bears ultimate responsibility for the content of its labels at all times. The Court then rejected Wyeth's argument that requiring it to comply with the state-law duty to provide a stronger warning would interfere with Congress' purpose of entrusting the FDA with drug labeling decisions. Rather, the Court reasoned that Congress did not intend to preempt state-law failure to warn actions when it created the Food, Drug, and Cosmetic Act. Justice Breyer wrote a separate concurring opinion noting that the FDA may create regulations that preempt state law tort claims, but such a regulation was not at issue in Ms. Levine's case. Justice Clarence Thomas wrote separately, concurring only in the judgment. He criticized the majority opinion for implicitly endorsing a "far-reaching implied pre-emption doctrine" where the Court invalidates state laws based on perceived conflicts with federal statutes by extrapolating from evidence not found in the text of the statute itself. Justice Samuel A. Alito dissented and was joined by Chief Justice John G. Roberts and Justice Antonin G. Scalia. He disagreed with the Court's holding that a jury, rather than the FDA is ultimately responsible for regulating warning labels for prescription drugs. He argued this is incompatible with the Court's precedent in Geier v. American Honda Motor Co. , which established the principles of conflict preemption.