WASHINGTON (AP) — Boston Scientific Corp. and its Guidant subsidiaries will pay $30 million to settle allegations that Guidant knowingly sold defective heart devices that health care facilities implanted in Medicare patients from 2002 to 2005, the Justice Department said Thursday.
Boston Scientific is headquartered in Natick, Mass., and acquired Guidant in 2006.
The Justice Department said that while Guidant took corrective action to fix the defects, the company continued selling its remaining stock of defective versions of the devices. In addition, the government alleged that as Guidant learned about the cause of the defect, it took steps to hide the problem from patients, doctors and the Food and Drug Administration, which regulates medical devices.
The devices are implantable defibrillators used in patients at risk of cardiac arrest due to an irregular heartbeat.
“Medicare patients who depend on cardiac defibrillators should not have to worry about whether their devices will work when they are needed,” Stuart F. Delery, assistant attorney general for the Justice Department’s Civil Division, said in a statement.
The complaint was filed in federal court in Minnesota. Guidant manufactured the implantable cardiac devices in the Twin Cities before the company was acquired by Boston Scientific.
Acting U.S. Attorney for Minnesota John R. Marti said that Guidant “valued profits more than patient safety by selling defective cardiac defibrillators.”
Boston Scientific said it continues to deny the allegations but “felt it was in the best interests of all parties to settle this matter and avoid further protracted litigation.”