Medical device maker Medtronic PLC has entered into three separate legal resolutions with the Justice Department, including a guilty plea and $50.9 million in civil settlements, the company said late Tuesday.
The three cases all involved schemes to promote sales of medical devices made by Medtronic subsidiaries ev3 and Covidien. All of the alleged activity occurred before Minnesota-run Medtronic acquired the companies in 2015.
Although ev3 did admit criminal wrongdoing in one case, Medtronic did not admit civil liability in the other two. Justice Department officials said the cases were part of their commitment to hold companies accountable for violating laws designed to safeguard health and public funds.
As of Wednesday afternoon, it wasn't entirely clear what alleged conduct Medtronic was resolving as part of the three separate resolutions.
No settlement documents in any of the cases had been publicly filed in their respective federal courts as of Wednesday.
In the first case, the U.S. Attorney's Office in Boston alleged that the sales staff of ev3 — formerly based in Plymouth — coached doctors on how to use a brain-surgery device for unapproved uses.
The device, called the Onyx Liquid Embolic System, is approved to close off blood flow to blood vessels in the brain that are prone to stroke.
The case says sales staff told doctors they could use the Onyx device to close off vessels in other parts of the body, even though the FDA said the device would have a much different safety profile if used outside the brain.
