June 26, 2015

Charlie Chi, the former president and CEO of OtisMed Corporation, was sentenced to two years in prison and to pay a $75,000 fine for intentionally distributing a medical device used in knee replacement surgery after its application for marketing clearance had been rejected by the Food and Drug Administration.  In September 2014, OtisMed, now a subsidiary of Stryker Corporation, was sentenced to a criminal fine of $34.4 million and ordered to pay $5.16 million in criminal forfeiture for this conduct.  In a related civil settlement, OtisMed agreed to pay approximately $41.2 million to resolve its civil liability for submitting false claims to the Medicare, TRICARE, Federal Employees Health Benefits and Medicaid programs.  DOJ

Tagged in: FCA Federal, FDA Fraud, Medical Devices and DME, Off-Label and Unapproved Use, Other Government Health Programs,