Medtronic Units Pay $31 Million in Justice Department Probe
By Patrick Thomas
Two companies owned by medical device giant Medtronic Plc (MDT) agreed to pay a combined $31 million to resolve allegations surrounding the unapproved use of a medical device and paying kickbacks to hospitals to get them to use a different product, the Justice Department said Tuesday.
ev3 Inc. pleaded guilty to charges related to its neurovascular medical device, Onyx Liquid Embolic System, and pay $17.9 million, according to the Department of Justice. Covidien LP, paid $13 million to resolve allegations resulting from its alleged payment of kickbacks. The Minnesota-based Medtronic, largest supplier of medical devices, acquired Covidien in 2015, who acquired ev3 in 2010.
ev3's Onyx device was approved by the Food and Drug Administration for use inside the brain only. The Justice Department says that from 2005 to 2009 ev3 sales representatives encouraged surgeons to use Onyx in large quantities in surgical uses outside the brain. Sales representatives also attended surgical procedures in order to provide instructions on how to use Onyx for procedures outside the brain, according to the plea agreement.
Separately, Covidien allegedly paid kickbacks to hospitals to use of its Solitaire mechanical thrombectomy device, which restore blood flow and retrieves a blood clots in certain stroke patients.
The Justice Department said Medtronic played no role in the criminal conduct, but the company also agreed to conduct compliance monitoring related to the Onyx sales marketing components.
"ev3 disregarded laws designed to protect patient safety," U.S. Attorney Andrew Lelling for the District of Masschusetts said in a prepared statement. "The U.S. Attorney's Office is committed to protecting patients and the integrity of federal health care programs, and we will continue to use our criminal authority to ensure that medical device manufacturers play by the rules that protect the public and ensure quality of care."
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