The Broad Reach Of New 'Failure-To-Warn-FDA' Claims

Law360, New York (January 23, 2013, 1:25 PM EST) -- Recently, the Ninth Circuit created a new state-law cause of action against medical device manufacturers: “failure to warn the U.S. Food and Drug Administration.” The en banc opinion in Stengel v. Medtronic Inc., __ F.3d __, 13 C.D.O.S. 365 (9th Cir. 2013), delivered by Judge William Fletcher, held that the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act (FDCA) did not preempt this claim because it paralleled a federal law duty imposed by the MDA.

This new cause of action opens the door, at least in the...
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