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May 27, 2016

Posted  June 13, 2016

Medical device manufacturer Paradigm Spine agreed to pay $585,000 to resolve allegations it violated the False Claims Act by marketing the company’s coflex-F® device for surgical uses that were not approved by the FDA.  The settlement further resolves allegations that Paradigm caused false claims by giving false recommendations on how to code health claims for procedures involving the company’s coflex® device.  The allegations originated in a whistleblower lawsuit filed by Chris Coyle, a former Paradigm Spine sales representative, under the qui tam provisions of the False Claims Act.  Mr. Coyle will receive a whistleblower award of approximately $105,300 from the proceeds of the government’s recovery.  DOJ (DMD)

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