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December 8, 2014

Posted  January 22, 2016

Medical products manufacturer OtisMed Corp and its former CEO Charlie Chi admitted to intentionally distributing knee replacement surgery cutting guides (called the OtisKnee) after the Food and Drug Administration (FDA) had rejected their application for marketing clearance. OtisMed agreed to pay more than $80M to resolve its related criminal and civil liability for distributing an adulterated medical device in violation of the Food, Drug, and Cosmetic Act (FDCA), and submitting fraudulent claims in violation of the False Claims Act. Whistleblower Insider

Tagged in: FCA Federal, Medical Devices and DME, Off-Label and Unapproved Use,