Impossibility Preemption Is Possible In 510(k) Device Cases

Law360, New York (October 9, 2015, 10:21 AM EDT) -- We have alluded on a couple of occasions to the likelihood that the recent generic drug implied impossibility preemption decisions in PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), can provide the basis for using this type of preemption in certain cases involving medical devices cleared under the the Food, Drug and Cosmetic Act's §510(k) "substantial equivalence" process. These are mostly Class II devices, but also encompass some falling into Class III (go here for more on that). We've also noticed that, in the two years since Bartlett added the most significant piece to this puzzle, there's hardly any case law on point — only one decision, In re DePuy Orthopaedics Inc. Pinnacle Hip Implant Products Liability Litigation, (N.D. Tex. July 18, 2014), which is both superficial and adverse....

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