In the wake of the U.S. Supreme Court’s decision in Riegel v. Medtronic (2008), plaintiffs have been searching for creative theories of liability against Class III medical device manufacturers that escape the purview of federal pre-emption. Riegel generally holds that product liability claims alleging state law requirements relating to safety and efficacy that are “different, or in addition to” those imposed on medical device manufacturers by the U.S. Food and Drug Administration’s premarket approval process are expressly pre-empted. As a result, the decision swiftly foreclosed an entire category of products liability litigation on behalf of a heavily active plaintiffs personal injury bar.
Finding ways to navigate around Riegel has not been easy. One avenue that lawyers have pursued with limited success is filing traditional product liability cases and pleading so-called “parallel requirements”—the limited exception to Riegel for alleged obligations that parallel, rather than add to, the federal requirements set forth in the Food, Drug, and Cosmetic Act (FDCA). So far, attempts to carve out such requirements have largely failed to bear fruit, with most courts holding that the alleged parallel requirements are not parallel at all; rather, they are additional requirements dressed up as parallel claims and, thus, pre-empted. Far from expounding on the exception espoused by the Supreme Court, these claims have instead added to the body of cases defining those claims that are included in the confines of expressed and implied pre-emption.
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