OtisMed and the company’s CEO pled guilty recently and a judge fined the company $34.4 million and ordered a $5.16 million in criminal forfeiture in addition to paying $40 million plus interest to resolve its civil liability, according to the report.
Here are five quick facts on the agreement:
1. The government will not criminally prosecute Stryker. OtisMed distributed the implants before Stryker purchased the company, and Stryker didn’t know about the distribution at the time of purchase.
2. As part of the agreement, Stryker will conduct a review and audit into whether there have been other instances of marketed devices without FDA approvals.
3. Audit results will be shared with the government.
4. In addition to the audit and review, Stryker agreed to annual certification from orthopedics group presidents and board of directors on compliance program effectiveness.
5. Ropes & Gray’s Brien O’Connor and Joshua Levy represented Stryker and OtisMed.
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