Riegel Loophole Keeps PMA Device Cases Afloat, Barely

Law360, New York (July 17, 2013, 9:40 PM EDT) -- The U.S. Supreme Court ruled five years ago that federal law preempts most allegations targeting medical devices that have received pre-market approval. Medical device makers now face fewer lawsuits because of the ruling, as was expected, but plaintiffs have exploited a loophole in the decision to sustain a small category of claims over the products.

The court held in Riegel v. Medtronic in February 2008 that plaintiffs cannot challenge under state law the safety or effectiveness of a device preapproved by the U.S. Food and Drug...
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