Novo Nordisk to Pay $60 Million

Novo Nordisk will pay $60 million to settle seven whistleblower-initiated False Claims Act lawsuits involving “Risk Evaluation and Mitigation Strategy” (REMS) related to the marketing and sale of Victoza, a Type II diabetes medication that, when FDA-approved in 2010, required the company to mitigate the potential risk in humans of a rare form of cancer called Medullary Thyroid Carcinoma (MTC) that was associated with the drug. Instead of engaging in the proper warning and monitoring, Novartis sales staff gave information to physicians that created the false or misleading impression that the Victoza REMS-required message was erroneous, irrelevant, or unimportant.

The resolution of these cases includes a payment of $46.5 million for False Claims Act claims from 2010 to 2014, a disgorgement of $12.15 million for violations of the Food, Drug, and Cosmetic Act from 2010 to 2012, and payments of $1.1 million and $350,000 to California and Illinois under their state insurance laws that work to recover funds linked to losses of private insurers.

1 view0 comments

Recent Posts

See All