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FDA Regulation of Medical Devices

Lawrence O. Gostin, JD

JAMA. 2008;299(19):2313-2316.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

Charles Riegel underwent coronary angioplasty in 1996, shortly after sustaining a myocardial infarction. Mr Riegel's physician inserted the Evergreen balloon catheter, a medical device approved by the US Food and Drug Administration (FDA), into his patient's coronary artery in an attempt to dilate the artery, but the catheter ruptured. Mr Riegel developed complete heart block, was placed on life support, and underwent emergency coronary artery bypass graft surgery. He sued Medtronic, the manufacturer of the device, alleging that the company was liable under New York tort law in designing, testing, inspecting, labeling, and marketing the catheter. On February 20, 2008, the Supreme Court held that the Medical Device Amendments of 1976 (MDA) bars common law claims challenging the safety or effectiveness of a medical device marketed in a form that received premarket approval from the FDA. Riegel v Medtronic Inc has broad implications for patient safety . . . [Full Text of this Article]

The MDA and Preemption

Author Affiliation: O’Neill Institute for National and Global Health Law, Georgetown University Law Center, Washington, DC.