Feds scrutinizing two cardiac device makers

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 - investigation, magnifying glass

Two manufacturers are under the federal magnifying glass with investigations involving implantable cardiac devices. The investigations are unrelated.

In a recent filing with the Securities and Exchange Commission, Boston Scientific reported that on May 5 it was served a subpoena from the Office of the Inspector General requesting information about its Cognis cardiac resynchronization therapy-defibrillators and its Teligen implantable cardioverter-defibrillators. The Natick, Mass.-based company said the subpoena focused on the 2008 launch of the devices, their performance from 2007 to 2009 and the Physician Guided Learning Program.

St. Paul, Minn.-based St. Jude Medical also reported that in April it had been contacted by the Department of Justice (DOJ) saying that the company was under investigation for potential violation of the False Claims Act. According to St. Jude’s filing, the DOJ was investigating allegations that some facilities and a physicians group submitted false claims for federal reimbursement after allegedly being induced by the company to implant its cardiac devices.

Both companies said they are cooperating with the investigations.