Company Hid Serious Problems with Aorta Graft Product

Kahn Gauthier Swick is investigating possible lawsuits against EndoVascular Technologies, Inc., a wholly-owned subsidiary of medical device manufacturer Guidant Corporation, on behalf of persons who were implanted with the Guidant EndoVascular's Ancure Endograft System, which is used to repair abdominal aorta aneurysms. EndoVascular/Guidant has now admitted that Guidant lied to the government and concealed serious problems with the device, leading to at least a dozen deaths. Guidant has also pled guilty to 10 felonies in a prosecution by the U.S. government.

The federal Food and Drug Administration approved the Guidant Ancure system on September 28, 1999. The scope of the problems began to surface in the fall of 2000, when seven anonymous employees sent a letter to the FDA providing details about the failures and problems that were occurring. EndoVascular/Guidant recalled the Ancure system on March 16, 2001, and reintroduced it in August of that year. While the company previously submitted 172 reports of problems, it has now admitted that the real number was much higher: 2,628 additional reports of problems, out of a total of 7,632 Guidant devices that were sold.

The problems with the Guidant device centered on the system used to insert it. The equipment could become lodged, potentially requiring emergency surgery to remove it. In some cases, it was broken into pieces before being removed--a technique devised by sales representatives.

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