A settlement has been reached in a whistleblower class action lawsuit brought against OtisMed Corporation who is accused of marketing and distributing the OtisKnee without receiving approval or clearance from the FDA for the device.
OtisMed was fined $34.4 million in the criminal action and was ordered to pay $5.16 million in criminal forfeiture. Additionally, OtisMed agreed to pay $41.2 million to resolve the originally filed whistleblower lawsuit.