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Pre-Approved Medical Devices Immune From Personal Injury Liability

February 26, 2008

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In Riegel v. Medtronic, patient Charles Riegel was injured in 1996 when a balloon catheter burst while being inserted to dilate a coronary artery. Prior to this accident, in 1994, this medical device was awarded premarket approval from the Food and Drug Administration. In affirming the dismissal of plaintiff's state lawsuit, the United States Supreme Court held that medical devices that are approved by the F.D.A. cannot be subject to personal injury lawsuits unless the device was made improperly, in violation of F.D.A. specifications. At the center of this decision was the interpretation of the Medical Device Amendments Act of 1976 that bars states from imposing "any requirement" related to a medical device that is "different from, or in addition to" a federal requirement.
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