November 19, 2020

Johnson & Johnson (J&J) subsidiary Medical Device Business Services, Inc. (MDBS) has agreed to pay $10 million to settle allegations that a former J&J subsidiary, Therakos, Inc., promoted two medical devices for unapproved uses in pediatric patients.  A second entity, The Gores Group (TGG), agreed to pay $1.5 million to settle allegations of continuing to promote the devices for unapproved uses after it acquired Therakos in 2012.  In an action initiated by a whistleblower, the government alleged that between 2006 and 2015, Therakos improperly promoted its extracorporeal photopheresis (ECP) systems, used to treat cutaneous T-cell lymphoma, for use in children despite the fact that no ECP devices had been approved for that population.  In so doing, Therakos allegedly caused false claims to be submitted to Medicaid, the Federal Employee Health Benefits Program, and TRICARE, in violation of the False Claims Act.  The total settlement funds were divided between federal and state governments.  USAO EDPA; CA

Tagged in: FCA Federal, Medicaid, Medical Devices and DME, Off-Label and Unapproved Use, Other Government Health Programs, Whistleblower Case,