Wyeth v. Levine
Wyeth v. Levine, 555 U.S. 555, is a United States Supreme Court case holding that Federal regulatory approval of a medication does not shield the manufacturer from liability under state law.
Facts
Vermont jury trial
The plaintiff lost her forearm to gangrene when she was injected with Phenergan, an anti-nausea drug made by Wyeth Pharmaceuticals. She won a jury verdict in Vermont, under the theory that Wyeth had inadequately labeled the drug.Phenergan's regulatory background
The trial record shows that the FDA first cleared injectable Phenergan for use in 1955. In 1973 and 1976, Wyeth submitted supplemental new drug applications, which the agency cleared after proposing labeling changes. Wyeth submitted a third supplemental application in 1981 in response to a new FDA rule governing drug labels. Over the next 17 years, Wyeth and the FDA intermittently corresponded about Phenergan's label. The most notable activity occurred in 1987, when the FDA suggested different warnings about the risk of arterial exposure, and in 1988, when Wyeth submitted revised labeling incorporating the proposed changes. The FDA did not respond. Instead, in 1996, it requested from Wyeth the labeling then in use and, without addressing Wyeth's 1988 submission, instructed it to "retain verbiage in current label" regarding intra-arterial injection. After a few further changes to the labeling not related to intra-arterial injection, the FDA cleared Wyeth's 1981 application in 1998, instructing that Phenergan's final printed label "must be identical" to the approved package insert.Wyeth's motion for judgment as a matter of law
Wyeth argued that this Vermont law was federally preempted because it was in "actual conflict a specific FDA order" regarding drug labeling. The trial court rejected this argument, as did the Supreme Court of Vermont, holding that the FDA requirements merely provide a floor, not a ceiling, for state regulation. The Supreme Court granted certiorari.Issue
If a drug meets the labeling requirements of the FDA, does that give rise to federal preemption of state law regarding inadequate labeling? Wyeth presented two arguments in favor of FDA Preemption:- It is impossible for Wyeth to comply with both the state-law duties and federal labeling regulations, see Fidelity Fed. Sav. & Loan Assn. v. De la Cuesta, since the latter forbids it from changing its label without FDA approval.
- Permitting states to require stronger warnings creates an unacceptable "obstacle to the accomplishment and execution of the full purposes and objectives of Congress," Hines v. Davidowitz, because it substitutes a lay jury's decision about drug labeling for the expert judgment that Congress sought to entrust with drug labeling decisions when it created the FDA.
Holding
Justice John Paul Stevens, writing on behalf of a 6-3 court, rejected both of Wyeth's arguments. In other words, the Vermont law was not preempted by FDA regulations; thus, the plaintiff could argue her case before a state court jury.In 2019, the issue was revisited in Merck Sharp and Dohme Corp. v. Albrecht. The Supreme Court found in that case that the appellant had demonstrated sufficient evidence to prove that the FDA had considered and rejected, and thus preempted, an addition to a warning label for Fosamax.
Reasoning
Questions of federal preemption "must be guided by two cornerstones of our pre-emption jurisprudence":In its first argument, Wyeth is incorrect that relabeling the drug to conform to Vermont law would necessarily have violated federal labeling regulations.
'''In its second argument, Wyeth is incorrect that permitting states to require stronger warnings would interfere with Congress' purpose of entrusting an expert agency with drug labeling decisions because it was not Congress's intent, in writing the Food, Drug, and Cosmetic Act, to preempt state-law failure to warn actions.'''