The Sixth Circuit recently held that a failure-to-warn claim could proceed against a generic manufacturer that had failed to timely follow the brand-name label. Fulgenzi v. Pliva Inc., Case No. 12-3504 (6th Cir. March 13, 2013). In doing so, the court created a narrow exception to the preemption defense established by Pliva Inc. v. Mensing, 131 S. Ct. 2567 (2011).
Liability for Generic Manufacturers After Mensing -
In Mensing¸ the U.S. Supreme Court held that failure-to-warn claims against generic drug manufacturers were preempted because it was impossible to comply with both state and federal law. The court reasoned that, because federal law requires generic manufacturers to maintain the “same” labels as that of the branded drug, it is impossible for generic manufacturers to independently change their drugs’ labels to avoid liability for failure-to-warn claims under state law.
Originally published in Law360 on April 04, 2013.
Please see full alert below for more information.
Firefox recommends the PDF Plugin for Mac OS X for viewing PDF documents in your browser.
We can also show you Legal Updates using the Google Viewer; however, you will need to be logged into Google Docs to view them.
Please choose one of the above to proceed!
LOADING PDF: If there are any problems, click here to download the file.
Topics: Failure To Warn, FDA, FDCA, Generic Drugs, Labeling, Manufacturers, PLIVA v Mensing, Preemption, SCOTUS
Published In: Civil Procedure Updates, Products Liability Updates, Science, Computers & Technology 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.
© Morrison & Foerster LLP | Attorney Advertising