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May 13, 2014

BSX subpoenaed over heart devices

Boston Scientific said it received a subpoena last week from federal regulators, seeking documents about some of its heart devices.

The Natick-based pharmaceutical company said in a filing last week that the U.S. Department of Health and Human Services was seeking information about the 2008 launch and the 2007 to 2009 performance of two brands of implanted defibrillators, which are used to shock a dangerously racing heartbeat back into a normal rhythm.

The subpoena also sought information about the operation of a “Physician Guided Learning Program.” BSX said it is cooperating with the request.

The announcement comes less than a year after BSX agreed to pay $30 million to settle Department of Justice allegations that the Guidant unit it acquired in 2006 knowingly sold defective heart devices.

The medical device industry has come under recent scrutiny for reportedly using illegal incentives to gain market shares and increase the prevalence of their devices. Minnesota-based St. Jude Medical announced last week that the U.S. Department of Justice is investigating them for allegedly paying health care providers in exchange for implanting its devices.

BSX’s stock price has been relatively stable since the announcement.

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