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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.

On December 17, 2020, the DOJ announced that Biogen agreed to pay $22 million to resolve allegations that it violated the False Claims Act by illegally using two non-profit foundations as a conduit to pay the copays for Medicare patients taking Biogen’s multiple sclerosis drugs, Avonex and Tysabri.  As part of the alleged scheme, Biogen

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

On October 22, 2020, the former CEO of Indivior PLC, Shaun Thaxter, was sentenced to six months of imprisonment for his conviction on one misdemeanor count of misbranding in violation of the Federal Food, Drug, and Cosmetic Act (“FDCA”).

Thaxter’s conviction, which arises from Indivior’s marketing of its opioid-based product Suboxone Film, is particularly significant

On October 14, 2020, the DOJ announced that it had finalized settlement negotiations with Merit Medical over allegations that Merit provided illegal payments to physicians in order to induce those providers to use Merit products. Under the guise of an internal program known as the “Local Advertising Program,” Merit allegedly provided remuneration to healthcare providers