Medtronic to pay $51m to settle Covidien, ev3 DoJ investigations

Medtronic (NYSE:MDT) said yesterday that it agreed to pay $50.9 million to settle a number of U.S. Dept. of Justice probes into marketing activities from companies it acquired, Covidien and ev3. Medtronic said that its subsidiary ev3, acquired when the Fridley, Minn.-based medtech giant picked up Covidien in 2015, agreed to plead guilty to a misdemeanor charge related to its marketing of the Onyx Liquid Embolic System, pay $17.9 million and adopt new compliance and reporting terms for three years. The charges relate to ev3’s marketing of the device for “unproven and potentially dangerous uses,” federal prosecutors said in a DoJ release. The Onyx Liquid Embolic System won FDA approval in 2005 for blocking blood flow to arteriovenous malformations of the brain. Prosecutors in the case claim that sales reps from ev3 marketed the device for unapproved uses between 2005 and 2009, even after FDA officials contacted ev3 over “specific safety concerns regarding uses of Onyx outside the brain,” according to the release. In 2012, the FDA released a warning related to the Onyx system after receiving reports of more than 100 adverse events and nine patient deaths related to use of the device. “Ev3 disregarded laws designed to protect patient safety. 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 manufacturer...
Source: Mass Device - Category: Medical Devices Authors: Tags: Business/Financial News Featured Legal News Medtronic Source Type: news