A manufacturer of devices to repair weakened blood vessels pleaded guilty Thursday to covering up malfunctions that may have led to 12 deaths and many other complications.
Endovascular Technologies of Menlo Park, a subsidiary of Indianapolis-based Guidant Corp., agreed to pay $92.4 million in civil and criminal penalties to settle the federal case. The company also pleaded guilty to 10 felonies, including shipping misbranded products and making false statements to government regulators.
The problems involving the Ancure "stent-graft" device, which is used during operations to treat abdominal aneurysms, were resolved after the device was voluntarily recalled in March 2001 and before it was reintroduced five months later, the company said in a statement.
The device, inserted through the groin, was designed to let doctors operate on the problems with the aorta, the major carrier of blood from the heart. Sometimes the walls of the aorta weaken, a potentially dangerous condition called an aneurysm.
According to a study by UCLA School of Medicine professor Wesley S. Moore, about 40,000 patients have surgery on abdominal aneurysms each year. Some 15,000 people die from the condition, making it the 13th leading cause of death nationwide.
The Moore study reports that endovascular surgery to repair abdominal aneurysms has a mortality rate of 6 to 10 percent.
The Food and Drug Administration first approved the Ancure device in 1999.
According to court documents unsealed Thursday, federal prosecutors said the device often malfunctioned. Sometimes part of the surgical tool became lodged inside the patient.
The company was charged with failing to report as many as 2,600 malfunctions of the device, thus preventing the public and physicians from learning about "recurring malfunctions and other risks." The company was also accused of failing to report that other, more invasive surgeries were required after the device failed.
The criminal complaint alleged that the company misled the FDA and reported only 172 malfunctions since the product's introduction. The complaint alleged that the company had records of 2,628 malfunctioning incidents, including reports that the malfunctions led to 12 deaths and 57 traditional open-heart surgeries.
The complaint also charged that the company developed but did not formally test ways for dealing with malfunctions. One, involving breaking the tool into smaller pieces to allow their removal, was developed by sales representatives and not formally tested.
In court Thursday, U.S. District Judge Susan Illston asked vice president Jim Neupert "how did it happen?"
"We did not do the right thing," he responded.
U.S. Assistant Attorney Matt Jacobs said "this was not the result of mistake or error."
The company said none of the more than 18,000 patients who have Ancure Endograft implants is at risk because the problems highlighted by the case occurred during surgery.
The company said it has already set aside money to pay the fine levied under Thursday's settlement.
According to the New York Times, Guidant is still threatened by lawsuits from individual patients — several have been fired and thousands more loom. Guidant is also still trying to satisfy a settlement with the Department of Health and Human Services.