Justices Reinforce Federal Preemption In Riegel

Law360, New York (March 24, 2008, 12:00 AM EDT) -- A recent U.S. Supreme Court case will have a direct impact on plaintiffs' ability to sue medical device manufacturers for alleged product failures.

The FDA operates and administers a number of programs, including the Food, Drug, and Cosmetic Act, as well as certain amendments that are specific to medical devices. One of these amendments, the Medical Device Amendments of 1976 (MDA), created a process known as “premarket approval” for medical devices.

Given the highly regulated nature of medical products and devices, medical device manufacturers have long...
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