FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

Judge Dismisses Whistleblower Lawsuit Against Boston Scientific

Sept. 13, 2017
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A federal judge granted Boston Scientific’s motion to dismiss a 2011 lawsuit alleging False Claims Act violations related to the sale of certain models of its Cognis and Teligen defibrillators.

The amended complaint in the whistleblower lawsuit by physician Steven Higgins of Scripps Memorial Hospital — who had worked with the company as a researcher — claimed the manufacturer caused physicians to make false claims for Medicare and other federal health care program reimbursements by certifying that the defibrillators were “reasonable and necessary for the medical procedures in which the devices were implanted,” according to the Aug. 29 court order.

Boston Scientific began selling the defibrillators in Europe in February 2008, and European doctors soon reported difficulties in securely implanting them.

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