December 4, 2018
“Consumers rely on the FDA to ensure that there’s a reasonable assurance of safety and effectiveness for the approved uses of medical devices. When manufacturers ignore the FDA’s regulatory authority, they undermine these crucial assurances and put lives at risk. Our Office of Criminal Investigations investigated a bad actor who marketed their device for unapproved uses, potentially harming patients,” said FDA Commissioner Scott Gottlieb, M.D. “The ev3 agreement to plead guilty announced by the U.S. Department of Justice today is an example of the FDA’s comprehensive commitment to ensuring the safety of medical devices and investigating companies that put patients at risk. A key part of our overall efforts to promote safe and effective innovation and protect patients is our enforcement work related to unsafe practices and bad actors. In addition to investigating such activities, we’re advancing other new policies to assure post-market device safety, as we recently outlined in our 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.”
Today the Department of Justice announced that medical device manufacturer, ev3, has agreed to plead guilty to introducing an adulterated medical device into interstate commerce. The ev3 medical device, Onyx Liquid Embolic System, is approved by the FDA for use as a liquid embolization device that is surgically injected into blood vessels to block blood flow to arteriovenous malformations in the brain.
From 2005 – 2009, ev3 sales representatives encouraged surgeons to use Onyx for unproven and potentially dangerous surgical uses outside the brain. The firm also set up a system of sales quotas and bonuses that incentivized sales representatives to sell the device for unapproved uses and trained the sales force on how to instruct physicians on unapproved uses of the device. The company, ev3, is expected to pay a criminal fine of $11.9 million and forfeit $6 million.
DOJ press release
Statement from FDA Commissioner Scott Gottlieb, M.D., on how modern predicates can promote innovation and advance safety and effectiveness of medical devices that use 510(k) pathway
FDA In Brief: FDA’s increased inspections of medical device manufacturers and targeted risk-based approach leads to improved compliance
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.