January 25, 2018 Articles

Unavoidably Unsafe PMA Medical Devices

By James M. Beck

The defense side’s reflexive reaction to design defect claims asserted against FDA pre-market approved (PMA) medical devices has been “preemption” ever since the Supreme Court so held in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). Read a comprehensive list of such preemption decisions.

Nevertheless, some judges, particularly (but not always) in state court, react negatively to the very concept of federal preemption tort litigation. Thus, it can be wise not to put all of one’s dismissal eggs in one basket. A logical alternative argument, based on state law, starts with the same premise as preemption—that “the FDA requires a device that has received premarket approval to be made with almost no deviations from the specifications in its approval application.” Riegel, 552 U.S. at 323.

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