Government Enforcement

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