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A Pivotal Medical-Device Case
Curfman, Gregory D.
Drazen, Jeffrey M.
Article from Journal - ilmiah internasional
The New England Journal of Medicine (keterangan: ada di Proquest) vol. 358 no. 01 (Jan. 2008)
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Full Text PDF PDA Full Text Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation 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 . . .
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