LAWSUITS NEWS & LEGAL INFORMATION
$60M Deal Reached in Victoza Fraud Cases
This is a settlement for the Victoza Side Effects lawsuit.
Washington, DC: A $60 million deal has been agreed between Novo Nordisk Inc., and federal agencies who alleged the pharmaceutical company engaged in misleading marketing practices concerning its best selling Type 2 diabetes drug Victoza.
The US Department of Justice (DOJ) charged that the company misled physicians and insurers about the associated risk of cancer associated with Victoza, specifically that the drug has been linked to a rare cancer called medullary thyroid carcinoma.
According to the DOJ, the allegations go back to 2010, when the US Food and Drug Administration (FDA) initially approved the drug. The FDA had required Novo Nordisk to modify its FDA-mandated risk evaluation and mitigation strategies, or REMS, after a 2011 survey revealed that half of primary care doctors polled were unaware of the potential cancer risks associated with the drug, according to the DOJ. The drug has been linked to a rare cancer called medullary thyroid carcinoma, the DOJ said.
According to the terms of the deal, Novo Nordisk will pay over $43 million to the federal government and about $3.3 million to state Medicaid programs. The deal will resolve claims made the by agencies under the False Claims Act. Additionally, Novo Nordisk has agreed to turn over $12.15 million in profits to resolve claims made that it knowingly violated the federal Food, Drug and Cosmetic Act from 2010 to 2012.
The deal also resolved seven whistleblower lawsuits filed between 2010 and 2016. Eleven whistleblowers were involved in bringing the lawsuits, and at least one, made by Peter Dastous, a Novo Nordisk sales representative who was responsible for selling Victoza to endocrinologists in South Carolina and northern Georgia, alleged Medicaid fraud against private commercial health insurers, and the deal brings the aggregate settlement amount the company will pay to $60 million.
The federal suit is United States et al. v. Novo Nordisk Inc., case number 1:17-cv-01820, in the U.S. District Court for the District of Columbia. The whistleblower suit filed by Dastous is United States et al. ex rel. Dastous v. Novo Nordisk Inc., case number 1:11-cv-01662, in the U.S. District Court for the District of Columbia.
Published on Sep-6-17
The US Department of Justice (DOJ) charged that the company misled physicians and insurers about the associated risk of cancer associated with Victoza, specifically that the drug has been linked to a rare cancer called medullary thyroid carcinoma.
According to the DOJ, the allegations go back to 2010, when the US Food and Drug Administration (FDA) initially approved the drug. The FDA had required Novo Nordisk to modify its FDA-mandated risk evaluation and mitigation strategies, or REMS, after a 2011 survey revealed that half of primary care doctors polled were unaware of the potential cancer risks associated with the drug, according to the DOJ. The drug has been linked to a rare cancer called medullary thyroid carcinoma, the DOJ said.
According to the terms of the deal, Novo Nordisk will pay over $43 million to the federal government and about $3.3 million to state Medicaid programs. The deal will resolve claims made the by agencies under the False Claims Act. Additionally, Novo Nordisk has agreed to turn over $12.15 million in profits to resolve claims made that it knowingly violated the federal Food, Drug and Cosmetic Act from 2010 to 2012.
The deal also resolved seven whistleblower lawsuits filed between 2010 and 2016. Eleven whistleblowers were involved in bringing the lawsuits, and at least one, made by Peter Dastous, a Novo Nordisk sales representative who was responsible for selling Victoza to endocrinologists in South Carolina and northern Georgia, alleged Medicaid fraud against private commercial health insurers, and the deal brings the aggregate settlement amount the company will pay to $60 million.
The federal suit is United States et al. v. Novo Nordisk Inc., case number 1:17-cv-01820, in the U.S. District Court for the District of Columbia. The whistleblower suit filed by Dastous is United States et al. ex rel. Dastous v. Novo Nordisk Inc., case number 1:11-cv-01662, in the U.S. District Court for the District of Columbia.
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