BOSTON, Massachusetts – In a shocking turn of events, Minnesota-based medical device manufacturer ev3 Inc. has agreed to plead guilty to charges related to the distribution of its neurovascular medical device, Onyx Liquid Embolic System, and pay $17.9 million in fines and forfeiture.
According to court documents, Onyx was approved by the U.S. Food and Drug Administration (FDA) as a liquid embolization device that is surgically injected into blood vessels to block blood flow to arteriovenous malformations in the brain. However, from 2005 to 2009, ev3 sales representatives encouraged surgeons to use Onyx in large quantities for unproven and potentially dangerous surgical uses outside the brain.
The FDA has approved Onyx only for use inside the brain, despite the company’s sales force continuing to tout unapproved and potentially dangerous uses of Onyx even after FDA officials told ev3 executives in 2008 that they had specific safety concerns regarding uses of Onyx outside the brain.
“ev3 disregarded laws designed to protect patient safety,” said United States Attorney Andrew E. Lelling. “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.”
ev3 has agreed to plead guilty to a misdemeanor offense, to pay a criminal fine of $11.9 million, and to forfeit $6 million. The company’s actions put lives at risk and undermined the FDA’s regulatory authority.
“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,” said FDA Commissioner Scott Gottlieb, M.D.
ev3’s actions demonstrate a clear disregard for patient safety and the FDA’s regulatory authority. The company’s plea agreement and hefty fine serve as a warning to other medical device manufacturers to follow the law and prioritize patient safety.
Key Facts
- State: Massachusetts
- Category: White Collar Crime
- Source: DOJ Press Release â†â€â€
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