Wyeth v. Diana Levine (555 U.S. 555)
U.S. Supreme Court · decided March 4, 2009 · Supreme Court Database (Spaeth)
- Citation
- 555 U.S. 555 · 129 S. Ct. 1187
- Decided
- March 4, 2009
- Term
- October Term 2008
- Vote
- 6–3
- Majority author
- Justice Stevens
- Issue area
- Federalism
- Disposition
- Affirmed
- Outcome
- Petitioning party lost
- Ideological direction
- Conservative
Opinion excerpt
Justice Stevens delivered the opinion of the Court. Directly injecting the drug Phenergan into a patient’s vein creates a significant risk of catastrophic consequences. A Vermont jury found that petitioner Wyeth, the manufacturer of the drug, had failed to provide an adequate warning of that risk and awarded damages to respondent Diana Levine to compensate her for the amputation of her arm. The warnings on Phenergan’s label had been deemed sufficient by the federal Food and Drug Administration (FDA) when it approved Wyeth’s new drug application in 1955 and when it later approved changes in the drug’s labeling. The question we must decide is whether the FDA’s approvals provide Wyeth with a complete defense to Levine’s tort claims. We conclude that they do not. I Phenergan is Wyeth’s brand name for promethazine hydrochloride, an antihistamine used to treat nausea. The inject-able form of Phenergan can be administered intramuscularly or intravenously, and it can be administered intravenously through either the “IV-push” method, whereby the drug is injected directly into a patient’s vein, or the “IV-drip” method, whereby the drug is introduced into a saline solution in a hanging intravenous bag and slowly descends through a catheter inserted in a patient’s vein. The drug is corrosive and causes irreversible gangrene if it enters a patient’s artery. Levine’s injury resulted from…
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