FED ISSUES SUBPOENAS TO THREE CARDIAC DEVICE FIRMS
The Department of Justice has asked three large heart device manufacturers to turn over documents related to their implantable cardioverter defibrillators (ICDs) and pacemakers -- a move that comes amid increased scrutiny of cardiac device safety and sales practices in the ICD and pacemaker industry.
Medtronic, Guidant and St. Jude Medical reported late Oct. 25 the U.S. Attorney's Office in Boston had issued subpoenas requesting documents on cardiac devices, components, and monitoring equipment and services. Medtronic also noted the subpoena sought documents related to "a provision of benefit, if any, to persons in a position to recommend purchases of such devices; and the company's training and compliance materials relating to the fraud and abuse and anti-kickback statutes."
St. Jude said the civil subpoena requested documents on "general industry practices" related to the devices going back to January 2000. Guidant also reported it had received a separate subpoena from the U.S. Attorney's office in Minneapolis requesting documents related to its Ventax Prizm 2 and Contak Renewal 1 and 2 ICD devices, which have been the subject of recent FDA warnings because of product malfunctions.
All three firms said they would fully cooperate with the requests.
The subpoenas follow recent media reports alleging firms used postmarketing evaluation studies to mask marketing efforts that were designed to persuade physicians to use the companies' devices. The practice involved companies paying physicians to fill out surveys on products after implanting them in patients. Device manufacturers have acknowledged they run product evaluation programs that include payments to doctors. The payments reflect reasonable compensation for a physician's time, they said.
Meanwhile, heart device manufacturers are facing blistering criticism over the safety of the devices. Large product recalls by Medtronic, Boston Scientific and Guidant this year have alarmed the public and raised questions about device safety measures at the FDA.