Last week the Ninth Circuit created a new state-law cause of action against medical device manufacturers: “failure to warn the FDA.” The en banc opinion in Stengel v. Medtronic Inc., __ F.3d __, 2013 WL 106144, 13 C.D.O.S. 365 (9th Cir. 2013), delivered by Justice Fletcher, held that the Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetic Act (“FDCA”) did not preempt this claim because it parallels a federal-law duty imposed by the MDA. This new cause of action opens the door, at least in the Ninth Circuit, to claims against all medical device and drug manufacturers, and could defeat Mensing preemption of failure to warn claims against generic drug manufacturers.
THE ALLEGATIONS IN THE STENGELS’ AMENDED COMPLAINT -
In October 2000, Richard Stengel had a SynchroMed EL Pump and Catheter—manufactured by Medtronic—surgically implanted in his abdomen to deliver pain relief medication directly into his spine. In February 2005, Mr. Stengel collapsed, reporting heaviness and decreased sensation in his right leg. At the hospital, Mr. Stengel was diagnosed with ascending paralysis. The device was removed, but Mr. Stengel became a paraplegic. Mr. Stengel claimed the device caused his paralysis.
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: Drug Manufacturers, FDA, FDCA, Generic Drugs, Manufacturers, Medical Device Amendments, Medical Devices, Medtronics, Mensing, Preemption
Published In: Administrative Agency Updates, Civil Procedure Updates, Health 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