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Volume 357:1680-1681 October 25, 2007 Number 17
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Who Should Protect the Public? The Supreme Court and Medical Device Regulation
Russell Korobkin, J.D.

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A decade ago, Charles Riegel was undergoing a coronary angioplasty procedure when a balloon catheter ruptured. Complete heart block developed, and Riegel lost consciousness and had to undergo emergency coronary bypass surgery. A U.S. Court of Appeals ruled that Riegel could not sue Medtronic, the manufacturer of the catheter, for his injuries and resulting disability. The Supreme Court recently agreed to review that holding and will hear oral arguments later this fall. Its decision is expected by June 2008.

The technical issue in the case is the proper interpretation of the 1976 Medical Device Amendments (MDA) to the federal Food, . . . [Full Text of this Article]


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Mr. Korobkin is a professor at UCLA School of Law, Los Angeles, and a visiting professor at Harvard Law School, Cambridge, MA.



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