September 22, 2017
Aegerion Pharmaceuticals Inc., the Massachusetts-based subsidiary of
Novelion Therapeutics Inc., agreed to plead guilty to charges relating to its prescription drug Juxtapid. Specifically, Aegerion introduced Juxtapid into interstate commerce that was misbranded because, among other things, Aegerion failed to comply with a Risk Evaluation and Mitigation Strategy. Aegerion agreed to pay more than $35 million to resolve criminal and civil liability arising out of violations of the False Claims Act and Federal Food, Drug, and Cosmetic Act. The allegations originated in a whistleblower lawsuit filed under the
qui tam provisions of the False Claims Act by
Aegerion former employees Michele Clarke, Tricia Mullins, and Kristi Winge. They will receive a
whistleblower award of $4.7 million from the proceeds of the government's recovery.
DOJ