Wyeth v. Levine
Issues
Whether a drug manufacturer that has complied with the Food and Drug Administration’s labeling requirements can still be liable under state product liability laws on grounds that the label was inadequate.
In 2000, Diana Levine was treated with Phenergan to relieve nausea caused by a migraine headache. The drug was incorrectly administered into Levine’s vein, causing gangrene that ultimately led to the amputation of part of her arm. Levine sued Wyeth, Phenergan’s manufacturer, in Vermont Superior Court and the Supreme Court of Vermont on claims of negligence and products liability, arguing that Phenergan’s label was inadequate in warning consumers about its possible risks. Wyeth, on the other hand, argued that federal law preempted Levine’s state law claims, as state law directly conflicted with the requirements of the Federal Food, Drug and Cosmetic Act. With both lower courts ruling in favor of Levine, this case gives the Supreme Court an opportunity to further define the federal preemption doctrine by clarifying whether a drug manufacturer can be liable under state law after complying with the labeling requirements of the Food and Drug Administration. Stakeholders on both sides argue that the outcome of this case will have a direct impact on the kind of information included on drug labels and as such, has serious implications for patient safety and public health.
Questions as Framed for the Court by the Parties
Whether the prescription drug labeling judgments imposed on manufacturers by the Food and Drug Administration ("FDA") pursuant to FDA's comprehensive safety and efficacy authority under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., preempt state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use.
In April of 2000, Diana Levine sought medical treatment for symptoms, such as pain and nausea, caused by a migraine headache. See Levine v. Wyeth, 944 A.2d 179, 182 (Vt.
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Additional Resources
· Drug and Device Law Blog: Views on issues related to pharmaceutical and medical device product liability litigation.
· Pharmaceutical and Medical Devices: Fulbright & Jaworski L.L.P. Briefing on Wyeth v. Levine.
· Drug Injury Watch Blog:. Information about prescription drug side effects.