Fresh off a $300 million criminal settlement with Boston Scientific Corp. for selling defective pacemakers, government lawyers have filed a civil lawsuit against the devicemaker over the same allegations—and no settlement is in the works this time.
Feds file civil lawsuit against Boston Scientific
The government says executives at Arden Hills, Minn.-based Guidant—later acquired by Boston Scientific—knowingly sold three defective models of pacemakers between 2003 and 2005, choosing to ship their remaining stock and downplay safety concerns instead of reporting the problems to the Food and Drug Administration.
Company officials notified FDA that its Ventak Prizm 2, Renewal 1, and Renewal 2 internally implantable defibrillators were defective only after the New York Times published a front-page article that said one device was involved in the death of a 21-year-old man.
The corporation pleaded guilty to a criminal charge alleging the same facts, paying $300 million and agreeing to three years of probation on the corporation. On Thursday, the Justice Department filed a two-count civil lawsuit under the False Claims Act that seeks to recover triple damages for false claims made on about 2,000 devices billed to Medicare.
The company said it was disappointed in the government's latest action. “However, the company believes that the ultimate resolution of this matter should not have a significant financial impact,” Boston Scientific officials said in a news release.
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