Boston Scientific Subpoenaed Over Defibrillator Devices

By Joseph Walker 

Medical device maker Boston Scientific Corp. said it received a subpoena this week from the Department of Health and Human Services, seeking information about the performance of some of its implanted defibrillators.

The subpoena, received May 5, requested information related to the 2008 launch of two brands of implanted cardiac defibrillators, or ICDs, made by Boston Scientific, the company said in a regulatory filing Thursday. The subpoena also sought information related to the performance of the devices between 2007 and 2009, and the operation of a "Physician Guided Learning Program," the filing said. The defibrillators are sold under the brand names Cognis and Teligen.

The subpoena was issued by HHS's Office of the Inspector General, which is responsible for identifying fraud and waste in government health programs such as Medicare and Medicaid, according to the agency's website.

Boston Scientific said it is cooperating with the request.

The company, based in Natick, Mass., had net sales of $7.14 billion last year. In addition to defibrillators, the company makes other implanted heart devices including pacemakers and stents, which prop open narrowed or weakened arteries.

Boston Scientific competes against companies including Medtronic Inc. and St. Jude Medical Inc. in selling heart devices. The industry has come under increased scrutiny in recent years for allegedly using kickbacks and other illegal incentives to gain market share and increase the use of their devices among physicians.

Earlier this week, St. Jude Medical said in a regulatory filing that it received a civil investigative demand from the U.S. Department of Justice in April related to its cardiac devices. The Justice Department said it was investigating St. Jude for allegedly paying inducements to health care providers in exchange for implanting St. Jude's devices, the company said in the filing. St. Jude said it is working with the Justice Department in responding to the civil investigative demand.

Medtronic paid $23.5 million in 2011 to settle Justice Department allegations that it paid illegal kickbacks to physicians to induce them to implant Medtronic pacemakers and defibrillators.

In October 2013, Boston Scientific agreed to pay $30 million to settle Department of Justice allegations that its subsidiary Guidant Corp. had knowingly sold defective defibrillators between 2002 and 2005 that were implanted in Medicare patients. Boston Scientific acquired Guidant in 2006 in a deal valued at around $27 billion.

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