Unavoidably Unsafe PMA Medical Devices

When it comes to design defect claims and FDA pre-market approved ("PMA") medical devices, "preemption" is our reflexive reaction. That's entirely reasonable, given the many decisions that preempt state-law design-related claims since Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). We collect then all here.

Nevertheless, there are some judges, particularly (but not all) in state court, who react negatively to the very concept of preemption. Thus, a word to the wise is not to put all your dismissal eggs in one basket. One logical alternative argument 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.