Government Enforcement

On September 8, 2021, the U.S. Attorney’s Office for the District of New Jersey announced a settlement with BAYADA, BAYADA Home Health Care Inc., BAYADA Health LLC, and BAYADA Home Care (collectively, the BAYADA Companies) for $17 million. The settlement resolves allegations under the False Claims Act and Anti-Kickback Statute. No admissions of liability were made pursuant to the settlement.

Continue Reading The BAYADA Companies Settle FCA and Kickback Allegations for $17M

On Monday, August 2, the Department of Justice announced that Arriva Medical LLC (“Arriva”) and its parent company, Alere Inc. (“Alere”), agreed to pay $160 million to settle claims that they violated the False Claims Act.  Arriva was one of the largest mail-order diabetic supply companies in the nation until it ceased business operations in December 2017. Alere is a medical device company based in Abbott Park, Illinois, which acquired Arriva in November 2011. In 2013, a whistleblower brought suit against Arriva and Alere under the qui tam provisions of the False Claims Act. The United States subsequently intervened in the suit.

Continue Reading DOJ Announces $160 Million Settlement with Mail-Order Diabetic Testing Supplier and Parent Company

On July 21, 2021, a group of state attorneys general proposed a $26 billion settlement proposal to resolve claims that McKesson Corp., Cardinal Health, Inc., AmerisourceBergen Corp., and Johnson & Johnson (“J&J,” and together with McKesson Corp., Cardinal Health, Inc., and AmerisourceBergen Corp., the “Settling Parties”) contributed to the opioid epidemic in the United States.

Continue Reading Johnson & Johnson, McKesson Corp., AmerisourceBergen Corp, and Cardinal Health proceed with $26 billion Settlement with States to Resolve to Resolve Opioid Claims

On April 1, 2021, the DOJ announced that Bristol Meyers Squibb agreed to pay $75 million to resolve allegations that the company underpaid rebates owed under the Medicaid Drug Rebate Program. Of the total settlement amount, Bristol Meyers Squibb will pay approximately $41 million, plus interest, to the United States, and $34 million to participating

On April 27, 2021, the California Attorney General announced that Invidior plc and Invidior Inc. (collectively, “Invidior”) agreed to pay $300 million to settle claims that it falsely and aggressively marketed Suboxone, a drug product approved for use in recovering opioid addicts.

Continue Reading Invidior Pays $300M to Settle Claims that it Improperly Marketed Suboxone

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