Federal Government to Provide Its Position on Generic Preemption to the U.S. Supreme Court


Following the U.S. Supreme Court's March 2009 landmark decision in Wyeth v. Levine, state and federal courts have struggled with how to apply Levine to failure-to-warn products liability claims against generic pharmaceutical manufacturers. Since Levine involved only a brand drug, and because generic drug manufacturers' federal preemption arguments differ from those of brand-drug companies, courts in the wake of Levine have been unable to reach a consensus on whether Levine equally applies in the context of generic drugs. The federal government, however, will soon supply its views on generic preemption to the U.S. Supreme Court, providing key guidance and clarification on whether the U.S. Food and Drug Administration (FDA) believes that failure-to-warn suits against generic drug manufacturers are preempted by the Hatch-Waxman Act and other federal laws and regulations.

Please see full alert below for more information.

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

Published In: Administrative Agency Updates, General Business Updates, Conflict of Laws Updates, Health Updates, Products Liability Updates

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.

© Duane Morris LLP | Attorney Advertising

Don't miss a thing! Build a custom news brief:

Read fresh new writing on compliance, cybersecurity, Dodd-Frank, whistleblowers, social media, hiring & firing, patent reform, the NLRB, Obamacare, the SEC…

…or whatever matters the most to you. Follow authors, firms, and topics on JD Supra.

Create your news brief now - it's free and easy »