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Heart Surgery
Medtronic Statement Regarding U.S. Supreme Court's Granting of Certiorari in Riegel Case
July 10th, 2007
The United States Supreme Court today granted review in Riegel v. Medtronic (NYSE:MDT), a case in which a U.S. Food and Drug Administration-approved balloon catheter was used contrary to labeling instructions by the patient's physician. The decision to take up the case means that for the first time, the Supreme Court will decide whether a patient is precluded from seeking state court remedies against the manufacturer of a device approved by the FDA through its rigorous Pre-Market Approval (PMA) process. In the Riegel case, an Evergreen balloon catheter- no longer manufactured by Medtronic- was inflated by the patient's physician beyond the labeling restrictions and used...
Source: Drug Law Weekly (2007-07-10)
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