Department of Justice Hands Guidant a Painful Lesson

Originally Published MX July/August 2003

BUSINESS NEWS

Following the agreement of Guidant Corp. (Indianapolis) to pay the largest fine ever levied for violating FDA's medical device reporting requirements, industry analysts are taking a close look at the company's prospects for a full recovery.

In June, Guidant pled guilty to 10 felony counts involving sales of misbranded products and making false statements to government regulators. The charges were brought after Guidant failed to disclose adverse events relating to the implantation procedure for the company's stent-graft device, the Ancure endograft system, manufactured by its wholly owned subsidiary, Endovascular Technologies Inc. (EVT; Menlo Park, CA). As part of its settlement with the U.S. Department of Justice, the company agreed to pay a fine of $92.4 million.