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.

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