The Guidant Ancure Endograft Device - Defective Medical Devices
By Aaron Larson
Law Offices of Aaron Larson
September, 2003
A Product Liability Case Study
The Guidant Ancure Endograft Device was designed for the treatment of abdominal aortic aneurisms. The device was designed to be inserted through the femoral artery in the leg, such that it could be placed in the aorta without the need for major surgery. In late 1999, the device was approved for use in the United States. By the time the Ancure Endograft device was withdrawn from the market on March 15, 2002, approximately 18,000 patients worldwide had been implanted with the device.
It is alleged that Guidant was aware of malfuctions of its Ancure Endograph Device, but withheld that information from the public. Despite the Food and Drug Administration's medical device reporting (MDR) regulations, which require manufacturers to report certain adverse events ot the FDA, Guidant reporedly failed to file thousands of required reports, and thus withheld information about the dangers of their product from regulators, doctors, and patients. (Some are suggesting that history repeated itself in relation to electrical defects with the Guidant Defibrillator.)
During the time the Ancure Endograft device was available in the United States, Guidant filed 172 MDR's with the FDA. During a subsequent criminal investigation, Guidant admitted that it should have filed more than 2,600 additional MDR's, in relation to the approximately 7,600 devices it had sold. Failure of the Ancure Endograft device can necessitate emergency surgery, and can cause death. Obviously, this is an enormous rate of failure, which raises serious concern for any patient implanted with the device. As a result of its misconduct, in June of 1993, Guidant pled guilty to criminal charges, and elected to cease manufacture of the device.
Due to the significant variation in the law governing liability over defective products, when selecting a lawyer, it is usually a good idea to seek representation from a lawyer with experience handling this type of case.
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