United States ex rel v. Novo Nordisk (D. D.C.)
DOJ Announces that Novo Nordisk Agrees to Pay $58 Million for Failure to Comply with FDA-Mandated Risk Program
09/05/2017
Pharmaceutical Manufacturer Novo Nordisk Inc. pays $58.65 million to resolve allegations that the company failed to comply with the FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) for its Type II diabetes medication Victoza, the Justice Department announced today. The resolution includes disgorgement of $12.15 million for alleged violations of the Federal Food, Drug, and Cosmetic Act (FDCA) from 2010 to 2012 and a payment of $46.5 million for alleged violations of the False Claims Act (FCA) from 2010 to 2014. Novo Nordisk is a subsidiary of Novo Nordisk U.S. Holdings Inc., which is a subsidiary of Novo Nordisk A/S of Denmark. Novo Nordisk’s U.S. headquarters is in Plainsboro, New Jersey.
Murphy Anderson lawyers Mark Hanna, Ann Lugbill, and Michael Anderson represented two whistleblowers in this multi-party settlement and worked with Government lawyers at the Department of Justice and the U.S. Attorneys Office for the District of Columbia to develop the REMS/False Claims Act legal theory applied in this case--the first time such a violation of REMS was pursued successfully in a federal False Claims Act qui tam action.
09/05/2017