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Oct 2007
October 01, 2007

Supreme Court to Consider Restrictions on Medical Device Liability

The U.S. Supreme Court has accepted for review Riegel v. Medtronic, Inc., a case involving liability for medical manufacturers who make faulty products. The Court will decide whether the federal law that authorizes the FDA to preapprove some medical devices preempts state tort law and therefore state law claims. The plaintiff, Charles Riegel, experienced severe complications when a coronary artery catheter manufactured by Medtronic burst during his angioplasty. Riegel sued Medtronic under a variety of state law claims. Medtronic asserted that Section 360k(a) of the Medical Device Amendments to the Food, Drug, and Cosmetic Act preempted Riegel's claims, because the law forbids states from setting requirements that differ from or add to federal requirements. The District Court held that Riegel's claims were preempted and dismissed them; the U.S. Court of Appeals for the Second Circuit agreed. The Supreme Court must decide whether state law claims for defective medical services survived the passage of Section 360k(a).

A decision is expected in the spring of 2008 and will potentially affect thousands of medical device claims across the country. Interested parties should contact the Chair of our Appellate Practice Group, John Bursch, for more information about filing an amicus curiae brief in this case.

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