U.S. Supreme Court ruling limits suits targeting makers of FDA-approved medical devices

| February 21, 2008

        In a front-page story, the New York Times (2/21, A1, Greenhouse) reports that on Wednesday, the U.S. Supreme Court ruled in the case of Riegel v. Medtronic Inc. that "[m]akers of medical devices like implantable defibrillators or breast implants are immune from liability for personal injuries as long as the Food and Drug Administration (FDA) approved the device before it was marketed and it meets the agency’s specifications."

        The Los Angeles Times (2/21, Savage) notes, "The 8-to-1 ruling throws out a lawsuit brought by a widow whose husband was badly hurt and later died after a balloon catheter burst in his chest," and represents a broad reading of "federal law…to protect companies from juries or state regulators."

        The AP (2/21, Sherman, Yost) adds, "The case has significant implications for the $75 billion-a-year healthcare technology industry, whose products range from heart valves to toothbrushes." During "a recent three-month span, federal regulators responded to over 100 safety problems regarding medical devices."

        Turning to the implications the case has for patients, Bloomberg (2/21, Stohr) quotes Allison Zieve, the attorney representing the patient’s widow, as saying that the ruling is "[p]retty bad for patients, pretty good for industry profits." Zieve added, "Clearly a lot of people will lose their ability to have even the possibility of getting any compensation for injuries caused by medical devices."


Category: Government

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