Printer Friendly

Failure-to-warn claims allowed when generic drugs don't follow brand-name labels.

On March 13, in Fulgenzi v. PLIVA Inc., the 6th Circuit created a narrow exception to the Supreme Court's ruling in PLIVA Inc. v. Mensing, which held that failure-to-warn claims against generic-drug manufacturers are preempted.

In Mensing, the high court reasoned that because the law requires generics to have the same labels as brand-name drugs, generic manufacturers can't be subject to failure-to-warn claims.

In Fulgenzi, the brand-name drug Reglan received approval from the Food and Drug Administration to add the phrase "Therapy should not exceed 12 weeks in duration" to its label. PLIVA did not change the generic equivalent's label, and when Eleanor Fulgenzi developed tardive dyskinesia after taking the generic drug, she sued the company. The 6th Circuit found that when a generic manufacturer fails to follow the brand-name label in a timely manner, failure-to-warn claims are not preempted.

Kentucky, Michigan, Ohio, Tennessee
COPYRIGHT 2013 Summit Business Media
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2013 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Title Annotation:6TH CIRCUIT
Author:Beck, Julie
Date:May 1, 2013
Previous Article:Mississippi's $1 million cap on noneconomic damages is constitutional.
Next Article:Employees have duty to notify of need for FMLA leave.

Terms of use | Privacy policy | Copyright © 2018 Farlex, Inc. | Feedback | For webmasters