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Cases in Court

BY ALM Staff
August 26, 2003

California Medical Device Maker Pleads Guilty in Cover-up of Malfunctions

Endovascular Technologies, Inc., a wholly owned subsidiary of Guidant Corporation, based in Menlo Park, CA, pled guilty to a criminal information with ten felony counts, and agreed to pay $92.4 million to settle criminal and civil charges for covering up thousands of incidents involving the malfunction of a medical device (the 'Ancure device') used to treat aneurysms in the aorta. The incidents involved 12 deaths and dozens of invasive surgeries, according to a June 12, 2003, announcement by the U.S. Attorney's Office for the Northern District of California. Because the company knowingly failed to file required Medical Device Reports with the FDA, which the company knew about since it had a sales representative present in the operating room each time one of these devices was surgically implanted in a patient, it violated 21 U.S.C. ” 331(a) and 333(a)(2) ('Interstate Shipment of Misbranded Devices'). According to investigators, the government may charge company executives. The press release is available at www.usdoj.gov/usao/can/press/html/2003_06_12_endovascular.html

Pharmaceutical Company Agrees to Pay $18.5 Million

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