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Medtronic Fronts $51M to Resolve DOJ Case Over Unapproved Device Uses

Posted 05 December 2018 | By Ana Mulero 

Medtronic Fronts $51M to Resolve DOJ Case Over Unapproved Device Uses

Medtronic agreed to pay $51 million in a case brought on by the US Department of Justice (DOJ) over introducing an adulterated medical device into interstate commerce.

At the center of the off-label marketing litigation is the US Food and Drug Administration's (FDA) 2005 premarket approval on an use indication for a neurovascular device manufactured by ev3, which was acquired by Covidien in 2010, which Medtronic acquired in 2015. 

ev3 launched a sales and marketing campaign “shortly after” its Onyx Liquid Embolic System obtained FDA approval in 2005 for use in pre-surgical embolization of brain arteriovenous malformations “to distribute Onyx to physicians for uses that had not been approved,” according to court documents. The firm's "sales representatives encouraged surgeons to use Onyx in large quantities for unproven and potentially dangerous surgical uses outside the brain," DOJ reported. 

ev3 agreed to plead guilty to a misdemeanor offense regarding introduction of the adulterated Onyx medical device into interstate commerce. As a result, the firm will pay a criminal fine of $11.9 million. It also agreed to forfeit an additional $6 million, which is the amount ev3 was paid for the adulterated device, court filings state.

Medtronic committed to paying an additional $13 million to resolve DOJ’s investigations into its Systematic Evaluation of Patients Treated With Stroke Devices for Acute Ischemic Stroke Registry and $20 million to resolve the “matter concerning various market-development and physician engagement activities conducted by legacy Covidien and ev3 Peripheral Vascular and endoVenous businesses.”

The parent company stressed that it has not made an admission that neither its patient registry nor the cited sales and marketing activities “were improper or unlawful,” though it has “initiated additional compliance measures to prevent potential violations of the FD&C Act by ev3 and its employees.” ev3 has also adopted “new compliance and reporting terms for a period of three years,” Medtronic added.

In 2017, Medtronic faced a $12 million multi-state settlement to resolve deceptive marketing claims involving its Infuse device. The latest case was filed against ev3 based an investigation led by FDA’s Office of Criminal Investigations into the subsidiary’s marketing practices. FDA Commissioner Scott Gottlieb said of the ev3-DOJ agreement on Tuesday: “When manufacturers ignore the FDA’s regulatory authority, they undermine these crucial assurances and put lives at risk.”

Gottlieb also highlighted the recently updated medical device action plan and FDA’s commitment to a new active surveillance system.

DOJ

Categories: Regulatory News

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