Medical device manufacturer, parent company to pay more than $30 million for federal violations

By Marian Johns | Dec 7, 2018

WASHINGTON, D.C. — A medical device manufacturer along with its parent company have agreed  to pay more than $30 million for violations of the Food, Drug and Cosmetic Act and False Claims Act relating to their medical devices.

According to the U.S. Department of Justice (DOJ), ev3 Inc., and its parent company Covidien LP are part of the settlement that stems from separate alleged violations. 

The DOJ says ev3 will plead guilty to falsely promoting its Onyx Liquid Embolic System device to surgeons for use in "unproven and dangerous surgical uses" beyond the FDA's limited approval and will pay $17.9 million. Also, according to the DOJ, Covidien, which was not a part of the ev3's alleged illegal actions, will separately pay $13 million for allegedly paying kickbacks to get users for its Solitaire mechanical thrombectomy device.

“ev3 disregarded laws designed to protect patient safety,” said U.S. attorney for the District of Massachusetts Andrew Lelling in a 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.”

“Unnecessarily putting patients at risk to increase profits, as the government alleged in this case, will not be tolerated,” added Office of Inspector General of the U.S. Department of Health and Human Services special agent in charge Christian Schrank.  “We will continue to work with our federal partners and hold accountable companies that use deceptive practices to increase their bottom line.”

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