| pThe U.S. Supreme Court handed a victory to Medtronic Inc on Wednesday, ruling that patients cannot sue medical-device manufacturers in state court over harm from a device that has approval from federal regulators./ppBy an 8-1 vote, the court ruled a 1976 law creating federal safety oversight for medical devices bars state-law claims challenging safety or effectiveness of devices that have won premarket approval from the U.S. Food and Drug Administration./ppThe decision was the Supreme Court's first ruling on the legal effect of the FDA's approval of a medical device on liability lawsuits, Medtronic said./ppThe ruling could benefit other device makers, who have argued that the FDA's judgment that a product is safe and effective should protect companies from being sued for liability in state court./ppThe Medtronic case involved a New York man who was injured in 1996 when a doctor inflated a balloon catheter during an artery-clearing procedure./ppMedtronic has said the doctor in the case used the catheter contrary to labeling instructions and in a patient for whom it was not recommended. The company no longer makes that specific catheter./ppA federal trial court in Albany, New York, dismissed the lawsuit, finding the patient was not entitled to state law remedies because of the FDA's prior approval of the device./ppA U.S. appeals court agreed that the lawsuit was pre-empted by federal law, and the Supreme Court upheld that decision. /p |
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