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Editorial
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Volume 358:76-77 January 3, 2008 Number 1
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A Pivotal Medical-Device Case
Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D.

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This spring the Supreme Court of the United States will decide whether premarketing approval of a medical device by the Food and Drug Administration (FDA) immunizes the manufacturer against product-liability litigation in state courts. This decision, we believe, is a matter of particular importance to patients and the medical community.

On December 4, 2007, the Supreme Court heard oral arguments in Riegel v. Medtronic.1 In May 1996, Charles Riegel underwent coronary angioplasty in Albany, New York. During the procedure, the balloon ruptured, and advanced cardiac life support and emergency coronary bypass surgery were needed. Mr. Riegel and his wife . . . [Full Text of this Article]


Related Letters:

A Pivotal Medical-Device Case
Greenspan H., Picca S. M., Sonder G.
Extract | Full Text | PDF  
N Engl J Med 2008; 358:1758, Apr 17, 2008. Correspondence

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