Co. Accused of Hiding Heart Valve Defects
SAN FRANCISCO (AP) _ A manufacturer of a medical device pleaded guilty and agreed to pay $92.4 million in penalties Thursday for 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., pleaded guilty to 10 felonies, including shipping misbranded products and making false statements to government regulators.
Criminal charges against company executives also are being considered, prosecutors said.
``Because of the company’s conduct, thousands of patients underwent surgeries without knowing the risks they faced,″ U.S. Attorney Kevin Ryan said at a news conference. ``These actions were criminal.″
The problems involving the Ancure device, used to implant a patch to repair abdominal aortic 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, allows doctors to patch an aneurysm without abdominal surgery. The Food and Drug Administration first approved the device, which resembles a fishing pole, in 1999.
An aneurysm is a weak spot in the wall of the aorta _ the body’s largest blood vessel _ that bulges like a balloon until the pressure of pounding blood bursts it.
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 the implant procedure.
In court documents unsealed Thursday, federal prosecutors said that the Ancure device often malfunctioned and that the company asked doctors to use it in ways not approved by the government.
The company was charged with failing to report as many as 2,600 malfunctions of the $10,000 device, thus preventing the public and doctors from learning about the risks. The company was also accused of failing to report that other, more invasive operations were required after the device failed.
The criminal complaint alleged that the company misled the FDA and reported only 172 malfunctions. Prosecutors said the company had records of 2,628 malfunctions, including reports that the incidents may have led to 12 deaths and 57 surgeries.
In court Thursday, U.S. District Judge Susan Illston asked company 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 it has already set aside money to pay the penalties, which cover both civil and criminal charges.
Guidant shares fell $2.67, or 6 percent, to close at $40.56 Thursday on the New York Stock Exchange.