Guidant Subsidiary Pleads Guilty to 10 Felony Counts
Guidant subsidiary Endovascular Technologies, based in California, yesterday pleaded guilty to 10 federal felony counts for lying to the government and covering up 2,628 cases in which the delivery system on its stent-graft malfunctioned or was linked to deaths or serious injuries, the Wall Street Journal reports (Burton et al., Wall Street Journal, 6/13). The problems with the Ancure Endograft System, which was introduced in 1999 to treat a weakened aorta in the abdomen without surgery, centered on the stent-graft's delivery system, the New York Times reports. The device is placed in a flexible tube that is inserted through the thigh and maneuvered through the aorta to the weakened area and attached to the aorta allowing blood to flow past without putting pressure on the aneurysm. However, the device failed to work about every one in three times it was used, a fact Guidant concealed, the Times reports (Eichenwald, New York Times, 6/13). Under federal law, Guidant was required to report to the FDA any such serious malfunctions involving the Ancure device, the Washington Post reports (Hilzenrath, Washington Post, 6/13). The Ancure delivery system would often break, get stuck or otherwise malfunction. According to the government, when the delivery system malfunctioned, Guidant sales representatives -- who were required to be in the operating room -- tried to persuade doctors to avoid emergency surgery and instead told them to free the delivery system by breaking the handle of the device and removing the delivery system piece by piece, a method not approved by the FDA. According to the government, after a patient died in a case in which the unapproved removal technique was used, seven Guidant employees anonymously wrote to the FDA alleging fraud and cover-up (Wall Street Journal, 6/13). Guidant removed the Ancure device from the market in March 2001 to make changes to the device and then reintroduced it in August 2001, the New York Times reports (New York Times, 6/13). In the 19 months before the Ancure device was withdrawn, Guidant reported 172 malfunctions to the FDA; however, prosecutors said that Guidant knew that 2,628 malfunctions had occurred -- including 12 deaths -- giving it a failure rate of 34%, the Los Angeles Times reports (Gellene, Los Angeles Times, 6/13).
Guidant will have to pay $92.4 million in criminal and civil penalties -- the largest fine ever levied against a medical device manufacturer for failing to report problems to the FDA. As part of the plea, Guidant has agreed to cooperate with the investigations against executives who might have been involved in the wrongdoing. Guidant also must put into place corporate integrity agreements, subject to the approval of HHS, in exchange for the agency not banning the company from government programs like Medicare. The legal problems for Guidant "are far from over" because it already faces lawsuits from individuals adversely affected by the device, and "thousands of patients" could still bring suits, the New York Times reports (New York Times, 6/13). "Because of the company's conduct, thousands of patients underwent surgeries without knowing the risks they faced, and their doctors -- through no fault of their own -- were unprepared to deal with those risks," U.S. Attorney Kevin Ryan said (Washington Post, 6/13). Kim Rice of the FDA Office of Criminal Investigation said, "Endovascular Technologies not only violated the law but put additional patients at risk. This did not happen by accident. These events represent serious threats to the public health and the FDA will not tolerate those threats" (Feder Ostrov et al., San Jose Mercury News, 6/13). In a statement yesterday, Guidant said no patient who currently has the Ancure device is in any danger because the risk came from the delivery system (New York Times, 6/13). A. Jay Graf, chair of operations of Guidant, said that most of the adverse events did not involve patient injury and some of the managers of the unit responsible for the cover up have been fired. Graf added that Guidant could have averted the need to report "thousands of incidents" if the company had made changes to Ancure's labeling reflecting the problems of the delivery device, according to the Journal (Wall Street Journal, 6/13).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.