Wyeth v. Levine
| Wyeth v. Levine | |
|---|---|
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| Argued November 3, 2008 Decided March 4, 2009 |
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| Full case name | Wyeth, Petitioner v. Diana Levine |
| Docket nos. | 06-1249 |
| Citations | 555 U.S. 555 (more)
129 S. Ct. 1187
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| Prior history | Judgment for plaintiff, Washington Superior Court, Vermont (2004); affirmed, 944 A. 2d 179 (Vt. 2006); cert. granted, 552 U. S. 1161 (2008). |
| 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. | |
| Court membership | |
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| Case opinions | |
| Majority | Stevens, joined by Kennedy, Souter, Ginsburg, Breyer |
| Concurrence | Breyer |
| Concurrence | Thomas |
| Dissent | Alito, joined by Roberts, Scalia |
Wyeth v. Levine, 555 U.S. 555 (2009), is a United States Supreme Court case holding that Federal regulatory clearance of a medication does not shield the manufacturer from liability under state law.
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. 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.
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