According to a recent news article from NJ.com, the president and founder of OtisMed Corp. recently admitted to shipping hundreds of artificial knee products without FDA approval and pleaded guilty to criminal charges.
Authorities are reporting defendant pleaded to guilty to three misdemeanor fraud counts related to a shipment of over 200 artificial knee devices to surgeons throughout the United States with full knowledge the United States Food and Drug Administration had not approved them. Prosecutors stated defendant will be sentenced in March of 2015 and faces up to three years in prison.
OtisMed, which has since been acquired by Stryker Corporation, plead guilty to felony charge of distributing an adulterated medical device into interstate commerce and must pay approximately $40 million in fines and restitution. The company will also be required to pay an additional $41.2 million in civil settlements related to false claims litigation.
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