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When PMA Preemption Stops at the Operating Room Door

ABSTRACT: Manufacturers of Class III medical devices have long relied on federal preemption under the Medical Device Amendments (“MDA”) as a powerful defense against state-law product liability claims. In Miller v. Rush University Medical Center (Northern District of Illinois), the Court reinforced that protection—but also clarified where it ends. Read on to understand why this decision offers important guidance for medical device manufacturers, distributors, hospitals, and their counsel—particularly regarding the growing litigation risk associated with industry representatives in surgical settings.

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