- Medical device company ev3 has agreed to plead guilty to charges related to a neurovascular device, Onyx Liquid Embolic System, which federal prosecutors say the company marketed for "unapproved and potentially dangerous" uses between 2005 and 2009. Medtronic acquired the company in 2015.
- A Department of Justice release Tuesday said that ev3 sales representatives encouraged surgeons to use Onyx in large quantities outside the brain though the device was solely approved by the FDA for use inside the brain.
- The company has accordingly agreed to pay $17.9 million total — a criminal fine of $11.9 million and a forfeiture of $6 million.
FDA approved ev3's Onyx Liquid Embolic System in 2005, which DOJ described as "a liquid embolization device that is surgically injected into blood vessels to block blood flow to arteriovenous malformations in the brain."
Sales reps allegedly attended surgical procedures and instructed physicians on unapproved uses of the device. More broadly, ev3's management also reportedly set up organizational trainings and incentives for sales reps to promote Onyx for unapproved uses.
Prosecutors said that members of ev3's sales team continued the illegal conduct in spite of concerns raised by FDA officials in 2008 regarding use of Onyx outside the brain. FDA officials told ev3 executives that a study would be required to gain approval for uses of Onyx outside the brain, which ev3 did not pursue.
ev3 was acquired by Covidien in 2010, which was picked up by Medtronic in 2015. The criminal conduct at ev3 took place more than five years before medical device behemoth Medtronic acquired the company.
DOJ pointed out that while Medtronic played no role in the criminal conduct, the medtech giant has "agreed to implement new compensation structures to ensure the sales force responsible for marketing Onyx is not incentivized to sell the device for unapproved uses." Medtronic will also conduct compliance monitoring related to the sales and marketing of Onyx.
FDA Commissioner Scott Gottlieb used the DOJ announcement to tout work by the agency's Office of Criminal Investigations.
"When manufacturers ignore the FDA's regulatory authority, they undermine these crucial assurances and put lives at risk," FDA Commissioner Scott Gottlieb said in a statement.
Gottlieb said investigations such as the one into ev3 are part of FDA's broader postmarket device safety goals, as outlined in the agency's Medical Device Safety Action Plan.
"The FDA is also committed to fully implementing a new active surveillance system that will enable the agency to harness real-world evidence from medical records and patient registries to more swiftly identify device safety issues and enable more informed decision-making," he said.