Boston Scientific announced today that it had agreed with the Department of Justice to plead guilty to “two misdemeanor charges related to failure to include information in reports” to the FDA and to pay $296 million to the government. The products involved in the investigation were the VENTAK PRIZM(®) 2, the CONTAK RENEWAL(®) and the CONTAK RENEWAL 2 devices, which were the subjects of the 2005 product advisories, the company said.
Separately, on page 29 of a 10-Q filed with the SEC, Boston Scientific disclosed that it had received a subpoena from the HHS Inspector General “requesting certain information relating to contributions made by CRM to charities with ties to physicians or their families.” The company said it was “currently working with the government to understand the scope of the subpoena.” No further details were disclosed.
William Maisel provided the following perspective on the subpoena to CardioBrief:
I have no specific insight or additional information on this matter. That being said, it appears that the OIG understands that conflicts of interest extend beyond simple direct payments to physicians. Specifically, conflicts of interest can include things such as academic notoriety or advancement and indirect payments to charities on behalf of a physician. At the same time, just because a physician receives payment or has a conflict of interest should not indict them, the company that made the payment, or their opinions about the product involved. Many important industry advances have come from close physician-industry ties.
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Friday, November 06, 2009
Boston Scientific closes one case for $296 million and discloses a new subpoena « CardioBrief
via cardiobrief.org
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