A Minnesota judge has signed off on a plea agreement that calls for Boston Scientific Corp.'s Guidant unit to pay $296 million for failing to properly disclose changes made to some implantable heart devices, but added three years of probation to the deal.
U.S. District Judge Donovan Frank rejected the plea deal last spring as insufficient. His acceptance Wednesday comes after Guidant filed papers giving him more information about its compliance policies and community service programs. Guidant has 10 days to pay the fines and forfeiture fees.
Prosecutors supported the plea agreement. They have called the $296 million in fines and forfeiture fees the largest criminal penalty ever against a medical device company.
As part of the probation, Frank said, the court will annually review Boston Scientific and Guidant's compliance efforts to make sure it can verify Boston Scientific keeps its commitments.
"We do believe it's fair and appropriate and a good resolution to the case," Assistant U.S. Attorney Robert Lewis said.
Attorneys for Guidant had no comment after the hearing.
Based in Indianapolis at the time, Guidant discovered short-circuiting problems in 2002 and 2004 with some of its defibrillators. Those problems might have left the devices unable to deliver lifesaving jolts that patients depended on. The company was accused of falsely reporting on changes to the devices or not reporting on them at all, leaving doctors and patients unaware of potentially dangerous problems.
The company eventually pleaded guilty to two misdemeanors: submitting a false and misleading report to the Food and Drug Administration about one defibrillator model and failing to notify regulators about a safety correction to another line of devices.
Boston Scientific acquired Guidant in 2006.
Find earlier coverage of the case by clicking here.
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