A major medical device manufacturer, Boston Scientific Corp., has settled a U.S. Department of Justice investigation by paying a fee and signing an integrity agreement. The company, which makes heart pacemakers, implantable heart defibrillators, heart stents and other medical devices, will pay $22 million in the civil settlement. The company will also sign a “Corporate Integrity Agreement” related to its pacemaker business. The agreement required the company to disclose on a website any payments to physicians.
The DOJ was investigating Boston Scientific’s subsidiary, Guidant Corp, for trying to boost sales by paying physicians between $1,000 and $1,500 to implant Guidant-brand pacemakers and defibrillators in patients. Guidant paid the physicians after the devices were implanted through four separate studies. The investigation began in 2005 prior to Boston Scientific acquiring Guidant Corp in 2006.
Boston Scientific agreed in November to pay $296 million to settle a separate DOJ investigation into product recalls issued by Guidant. The company says it received a subpoena from the U.S. Department of Health and Human Services, Office of Inspector General, to produce information about donations made by the pacemaker division of the company to charities with ties to physicians and their families.
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