Two companies now owned by Medtronic agree to pay $31M to resolve a U.S. Department of Justice probe into the marketing of a medical device meant to treat a vascular defect in the brain for unapproved purposes and paying kickbacks to hospitals to get them to use a second product.
The U.S. Food and Drug Administration in 2005 approved ev3 Inc.’s Onyx Liquid Embolic System for limited use in blocking blood flow to arteriovenous malformations in the brain, but federal prosecutors said sales staff sought to market it for other unapproved uses outside of the brain even after warnings not to do so.
The settlement also resolves civil claims that Covidien, another company now owned by MDT, paid kickbacks to hospitals to induce them to use its Solitaire mechanical thrombectomy device, which was intended to restore blood flow in stroke patients.