| Litigants: | Wyeth v. Levine |
| Arguedate: | November 3 |
| Argueyear: | 2008 |
| Decidedate: | March 4 |
| Decideyear: | 2009 |
| Fullname: | Wyeth, Petitioner v. Diana Levine |
| Docket: | 06-1249 |
| Usvol: | 555 |
| Uspage: | 555 |
| Parallelcitations: | 129 S. Ct. 1187; 173 L. Ed. 2d 51; 2009 U.S. LEXIS 1774 |
| Prior: | Judgment for plaintiff, Washington Superior Court, Vermont (2004); affirmed, 944 A.2d 179 (Vt. 2006); cert. granted, . |
| Holding: | Federal law does not pre-empt Levine’s claim that Phenergan’s label did not contain an adequate warning about the IV-push method of administration. Supreme Court of Vermont affirmed. |
| Majority: | Stevens |
| Joinmajority: | Kennedy, Souter, Ginsburg, Breyer |
| Concurrence: | Breyer |
| Concurrence2: | Thomas (in judgment) |
| Dissent: | Alito |
| Joindissent: | Roberts, Scalia |
Wyeth v. Levine, 555 U.S. 555 (2009), 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.[1]
The plaintiff lost her hand 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 (inter alia) that Wyeth had inadequately labeled the drug.
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 [the] 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 argued that this Vermont law was federally preempted because it was in "actual conflict [with] 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.[2] The Supreme Court granted certiorari.
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:
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 (or overruled) 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.[3] 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.
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.
Justice Breyer noted that, while the issue was not present here, the FDA may create regulations that pre-empt state law tort claims.
Justice Clarence Thomas wrote separately, concurring only in the judgment. He criticized the majority for implicitly endorsing a "far-reaching implied pre-emption doctrine" where the Court can invalidate state laws based on perceived conflicts with federal statutes by extrapolating from evidence not found in the text of the statute.
Justice Samuel Alito dissented and was joined by Chief Justice John G. Roberts and Justice Antonin 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 Geier v. American Honda Motor Co., which established the principles of conflict preemption.