Wyeth v. Levine: No Federal Preemption for Drug Labeling


The Supreme Court yesterday decided Wyeth v. Levine, the long-awaited decision on preemption of state court product liability claims against the pharmaceutical manufacturers. In a 6 to 3 decision, the Supreme Court determined that the foundation of federal regulation for pharmaceuticals is that the drug manufacturer has the responsibility for the adequacy of its warnings. The decision by Justice Stevens, joined by Kennedy, Souter, Ginsburg and Breyer, rejected Wyeth’s argument that it was impossible to comply both with FDA regulations on warnings and with a state law duty, imposed by jury verdict, that a stronger warning against a particular method of administration of the drug was required. The Supreme Court also rejected, over a rigorous dissent, the proposition that state court product liability claims obstructed the purposes and objectives of the federal drug labeling regulations.

Please see full alert for more information.

LOADING PDF: If there are any problems, click here to download the file.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Foley Hoag LLP | Attorney Advertising

Written by:


Foley Hoag LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.