10.18.13
When Boston Scientific Corporation bought Guidant Corporation in 2006, it didn’t see this coming.
Boston Scientific has now been ordered by the U.S. Justice Department to 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.
In 2010, similar allegations led Boston Scientific to plead guilty to two misdemeanor charges of withholding information from the U.S. Food and Drug Administration (FDA) and agree to pay $296 million in fines.
The latest settlement resolves a civil lawsuit the Justice Department brought in 2011 under a law designed to recover money defrauded from government programs such as Medicare.
According to the Justice Department, while Guidant took corrective action to fix the defects, the company continued selling its remaining stock of defective versions of the devices—implantable defibrillators used in patients at risk of cardiac arrest due to an irregular heartbeat. The government also alleged that as Guidant learned about the cause of the defect, it took steps to hide the problem from patients, doctors and the FDA.
“Medicare patients who depend on cardiac defibrillators should not have to worry about whether their devices will work when they are needed,” said Stuart F. Delery, assistant attorney general for the Justice Department’s Civil Division.
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.”
"[Patients who] received that Guidant defibrillator assuming that they were getting a high-quality device,” Jeanne Cooney, a spokeswoman for the U.S. Attorney for the District of Minnesota, told Minnesota Public Radio. “In fact, they were given in some instances—and this was known to Guidant—a device that actually became ineffective.”
Boston Scientific spokesman Peter Lucht said, “While the company continues to deny the allegations made in the complaint, it felt it was in the best interests of all parties to settle this matter and avoid further protracted litigation.”
Boston Scientific has now been ordered by the U.S. Justice Department to 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.
In 2010, similar allegations led Boston Scientific to plead guilty to two misdemeanor charges of withholding information from the U.S. Food and Drug Administration (FDA) and agree to pay $296 million in fines.
The latest settlement resolves a civil lawsuit the Justice Department brought in 2011 under a law designed to recover money defrauded from government programs such as Medicare.
According to the Justice Department, while Guidant took corrective action to fix the defects, the company continued selling its remaining stock of defective versions of the devices—implantable defibrillators used in patients at risk of cardiac arrest due to an irregular heartbeat. The government also alleged that as Guidant learned about the cause of the defect, it took steps to hide the problem from patients, doctors and the FDA.
“Medicare patients who depend on cardiac defibrillators should not have to worry about whether their devices will work when they are needed,” said Stuart F. Delery, assistant attorney general for the Justice Department’s Civil Division.
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.”
"[Patients who] received that Guidant defibrillator assuming that they were getting a high-quality device,” Jeanne Cooney, a spokeswoman for the U.S. Attorney for the District of Minnesota, told Minnesota Public Radio. “In fact, they were given in some instances—and this was known to Guidant—a device that actually became ineffective.”
Boston Scientific spokesman Peter Lucht said, “While the company continues to deny the allegations made in the complaint, it felt it was in the best interests of all parties to settle this matter and avoid further protracted litigation.”