Medtronic USA will pay over $9.2 million to settle allegations that it footed the bill for expensive events benefiting South Dakota neurosurgeon Wilson Asfora, MD, to induce him to use certain implantable devices, the Department of Justice announced Oct. 29.
Medtronic agreed to pay the U.S. $8.1 million to resolve allegations that it violated the False Claims Act, plus $1.11 million to settle allegations that it violated the Open Payments Program, which requires medical device manufacturers to make CMS aware of certain payments or transfers of value to a physician.
The federal government accused Medtronic of agreeing to Dr. Asfora's request that it pay for social events at Carnaval Brazilian Grill — knowing that Dr. Asfora owned the restaurant and would invite business partners, social acquaintances, favored colleagues and potential and existing referral sources — to induce him to use the company's SynchroMed II intrathecal infusion pumps.
Over a nine-year period, Medtronic allegedly paid for more than 100 events at Dr. Asfora's restaurant and did not properly report these payments to CMS. While Medtronic reached a settlement with the U.S. regarding these allegations, there has been no determination of liability.
Once the alleged wrongdoing came to light, Medtronic fired a sales representative and sales manager, according to the DOJ. Twelve other employees involved in the alleged misconduct were disciplined.
As part of the settlement, Medtronic agreed to cooperate with the DOJ's investigations of and litigation against other parties.
Dr. Asfora and two of his other companies are defendants in a separate lawsuit in which the U.S. became involved in November 2019. That lawsuit concerns allegations Dr. Asfora received kickbacks to use certain implants in his spinal surgeries, in violation of the False Claims Act.