Recently, the United States alleged medical device fraud when Medtronic companies (Medtronic plc, Medtronic Inc., Medtronic USA Inc., and Medtronic sofamor Danek USA Inc.) were caught allegedly importing products made in China and Malaysia which were prohibited under the agreement these companies had with the VA and DoD. According to the settlement agreement, these Medtronic companies certified its products between 2007 and 2014 would in fact be manufactured in the United States or in another designated country. The specific products involved in this case included: anchoring sleeves, cardiac leads, spine surgery devices, and a handheld patient assistant used with a wireless cardiac device. $4.41 million paid in settlement by the Medtronic companies covered these specific devices.
“Today’s settlement demonstrates our commitment to ensure that our service members and our veterans receive medical products that are manufactured in the United States and other countries that trade fairly with us,” said Acting Assistant Attorney General Benjamin C. Mizer or the Justice Department’s Civil Division. “The Justice Department will take action to hold medical device companies to the terms of their government contracts.”
“Domestic manufacture is a required component of many military and Veterans Administration contracts,” said U.S. Attorney Andrew M. Luger of the District of Minnesota. “Congress has mandated that the United States use its purchasing power to buy goods made in the United States or in designated countries. We take that mandate seriously and will not hesitate to take appropriate legal action to ensure compliance.”