Why is the case important?
A woman lost her hand and forearm to gangrene when she was injected with Phenergan, an anti-nausea drug made by Wyeth. She won a jury verdict in Vermont under a theory Wyeth had failed to include an adequate warning on the drug’s label.
Facts of the case
“Diana Levine filed this personal injury action against Wyeth, the drug manufacturer, in state court in Vermont. Ms. Levine had intravenously injected Phenergan, a drug made by Wyeth and used to prevent allergies and motion sickness, into her arm, and complications arising from the injection eventually led to the amputation of her arm. Ms. Levine brought this claim asserting that Wyeth had failed to include a warning label describing the possible arterial injuries that could occur from negligent injection of the drug. Wyeth argued that because their warning label had been deemed acceptable by the FDA, a federal agency, any Vermont state regulations making the label insufficient were preempted by the federal approval. The Superior Court of Vermont found in favor of Ms. Levine and denied Wyeth’s motion for a new trial.The Supreme Court of Vermont affirmed this ruling on appeal, holding that the FDA requirements merely provide a floor, not a ceiling, for state regulation. Therefore, states are free to create more stringent labeling requirements than federal law provides.”
If a drug meets the labeling requirements of the FDA, does that give rise to federal preemption of state law regarding inadequate labeling?
No, state common law claims do not provide an obstacle to the accomplishment of Congressional purposes in the FDCA.
In finding for the plaintiff, the Court held that the defendant failed to demonstrate that it was impossible for it to comply with both federal and state requirements. Further, the Court found that the CBE regulation permitted it to unilaterally strengthen its warning, and the mere fact that the FDA approved the drug’s label did not establish that it would have prohibited such a change. Additionally, there was powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.
- Case Brief: 2009
- Petitioner: Wyeth, Inc.
- Respondent: Diana Levine
- Decided by: Roberts Court
Citation: 555 US 555 (2009)
Granted Jan 18, 2008
Argued: Nov 3, 2008
Decided: Mar 4, 2009