Medtronic resolves medical device probes for $50.9M: 5 things to know

Medtronic will pay $50.9 million to resolve three U.S. Justice Department probes. The payments settle allegations that companies it now owns conducted improper medical device marketing, paid illegal kickbacks to hospitals and participated in other physician-engagement practices.

Here are five things to know:

1. Prosecutors claim ev3 Inc., which Medtronic acquired, marketed its Onyx Liquid Embolic System for unapproved and potentially dangerous uses. The device was approved by the FDA in 2005 to block blood flow to arteriovenous malformations in the brain. The lawsuit claims that ev3 sales staff marketed the device for areas outside of the brain, despite FDA warnings.

2. The Justice Department said Medtronic will pay $17.9 million and ev3 will plead guilty to a charge that it marketed its neurovascular medical device for unproven and potentially dangerous uses.

3. Medtronic is also resolving two other Justice Department probes. In one case, the Justice Department alleges Medtronic-owned Covidien paid kickbacks to hospitals to boost sales of its Solitaire medical thrombectomy device. This resulted in false claims for payments to Medicare and Medicaid. Medtronic will pay $13 million to resolve the kickback allegations.

4. The third claim concerns various market development and physician engagement activities conducted by Covidien and ev3. Medtronic agreed to pay $20 million to resolve the Justice Department investigation.  

5. "Medtronic is committed to maintaining the highest standards of ethical conduct and compliance with all applicable regulatory guidelines. The plea agreement and settlements that the Medtronic entities agreed to all concern matters that took place either largely or entirely prior to Medtronic acquiring the businesses in which the activities took place," a Medtronic statement reads.

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