os Inc. (formerly affiliated with Johnson & Johnson and later sold to The Gores Group) improperly marketed a cancer treatment for uses not approved by the FDA. More specifically, the government alleged that between 2006 and 2015, Therakos marketed and promoted its extracorporeal photopheresis systems to treat pediatric patients, even though the device was not approved by the FDA for pediatric use.
This case is indicative of a relatively new trend in FCA enforcement; whereas the government previously participated in qui tam allegations against private equity firms only rarely, as of late, the government has grown more active in prosecuting FCA violations where qui tam realtors allege misconduct by both the private equity sponsor and the portfolio company.
Related links available at: DOJ Press Release; Law 360 Press Coverage; J&J Settlement; The Gores Group Settlement.