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.

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Photo of Josh Levy Josh Levy

Joshua Levy is co-chair of the global Litigation and Enforcement practice group at Ropes & Gray LLP. He focuses on white collar defense and related complex civil litigation, particularly in the health care, pharmaceutical, medical device and Health IT industries. In 2019, Joshua…

Joshua Levy is co-chair of the global Litigation and Enforcement practice group at Ropes & Gray LLP. He focuses on white collar defense and related complex civil litigation, particularly in the health care, pharmaceutical, medical device and Health IT industries. In 2019, Joshua was lead counsel for one of the parents charged in the college admissions scandal. In 2018 and 2019, Joshua represented both Pfizer and Alexion in securing favorable False Claims Act settlements involving novel kickback theories relating to Patient Assistance Programs. In 2017, Joshua led a team that secured a $40 million criminal and civil global resolution with DOJ, FDA, OIG and the SEC, which included criminal misbranding and HIPAA charges. In 2016, Mr. Levy secured a complete acquittal after a three-week trial in federal court of a real estate developer and he was named as one of the Lawyers of the Year by Massachusetts Lawyers Weekly. In 2016, Joshua also led teams that secured the first DOJ declination under the FCPA Pilot Program and won a significant False Claims Act case dismissal in the First Circuit Court of Appeals.