The Department of Health and Human Services wants to know more about two heart devices made by Boston Scientific and has issued a subpoena.
As important as defibrillators may be to Boston Scientific’s top and bottom lines, some in the firm's legal department may instead read them as a dirty word because of the headaches the Natick, Massachusetts company has endured over them in the past.
Having bought Guidant and its defective heart devices in 2006, Boston Scientific ended up having to pay a penalty of $297 million after a district court in St. Paul, Minnesota found in 2011 that Guidant was guilty of misleading FDA regulators regarding the safety of some defibrillators. Separately, in a whistleblower case that was resolved just last October, Boston Scientific agreed to pay $30 million to settle charges that between “2002 and 2005, Guidant knowingly sold defective heart devices to health care facilities that in turn implanted the devices into Medicare patients” according to a Department of Justice news release.
And now, less than seven months later, it appears that the Natick, Massachusetts company’s defibrillators are under the spotlight again.
In its quarterly filing earlier this week, Boston Scientific revealed that on May 5 it received a subpoena from Department of Health and Human Services involving two heart devices. Specifically, HHS wants information on the 2008 launch of the Cognis and Teligen line of CRT-D and ICDs respectively, in addition to how those devices performed between 2007 and 2009. HHS also wants to know more about the Physician Guided Learning Program.
While cooperating with the request, Boston Scientific did not add any other information about the program and the devices in the filing.
An email to corporate representatives didn’t elicit an immediate response regarding questions about how many patients are implanted with these devices and the profile of the Physician Guided Learning Program.
Currently, Cognis and Teligen are described as the world's thinnest, high-energy CRT-D and ICD respectively on their individual product pages. A Boston Scientific news release announcing their FDA approval in May 2008 said they are the "among the world's smallest and thinnest high-energy devices...."
FDA's MAUDE Database shows eight reports reports associated with the Cognis CRT-D device in the time period that the HHS is reviewing. There are instances when the device malfunctions and when repeat OR intervention is required. The Teligen ICD device yielded six adverse events reports in the same 2007-2009 period, where problems included lead fracture and inappropriate shocking of the patient.
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