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HHS Probes Cardiac Defibrillators Manufactured by Boston Scientific Corp.

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This week, the U.S. Department of Health and Human Services (HHS) subpoenaed Boston Scientific Corporation for information relating to the medical device maker’s 2008 launch of two brands of implantable cardiac defibrillators (ICDs) and their performance between 2007 and 2009, as well as the operation of a “Physical Guided Learning Program.”

The defibrillators are sold under the brand names Cognis and Teligen, according to the Wall Street Journal (WSJ).

The HHS’s Office of the Inspector General issued the subpoena to Boston Scientific. The agency is responsible for identifying fraud in Medicare, Medicaid, and other government health programs, WSJ reported.

Boston Scientific, which earned $7.14 billion in net sales last year, also makes heart pacemakers and stents, as do its competitors, Medtronic Inc., and St. Jude Medical.

In October 2013, Boston Scientific agreed to pay $30 million to settle allegations that its subsidiary Guidant Corp. had knowingly sold defective defibrillators between 2002 and 2005 that were used in Medicare patients.

Additionally, the firm recalled approximately 73,000 Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) in early April, due to a faulty capacitor that caused the devices’ batteries to drain more quickly than expected. At least six people died as a direct cause of the defect.

The industry has been under the watchful eye of federal health officials more and more in recent years after it was revealed that the companies used illegal methods for increasing their market shares and the use of their devices among physicians, including providing kickbacks, according to WSJ.

St. Jude Medical said in a regulatory filing earlier this week that it received a civil investigative demand from the U.S. Department of Justice in April. The department said it is looking into whether the company paid inducements to health care providers in exchange for implanting St. Jude’s cardiac devices, WSJ reported.

The medical device maker has had numerous problems with its products over the years, including its Riata lead wires, which perforated the hearts of some of its patients. Some of the company’s Durata lead wires broke free of their insulated coating, putting patients at risk for serious injuries.

Medtronic paid $23.5 million to the Justice Department in 2011 to settle accusations that it gave kickbacks to doctors to sway them to implant Medtronic pacemakers and defibrillators. The company is also contending with lawsuits filed by patients who allege they were seriously injured by Medtronic’s bone growth product, Infuse. disclaimer: This article: HHS Probes Cardiac Defibrillators Manufactured by Boston Scientific Corp. was posted on Friday, May 9th, 2014 at 4:50 pm at and is filed under Medical Device Lawsuits, Medical Malpractice Lawsuits, Other Lawsuits, Personal Injury Lawsuits.

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