HOUSTON, Sept. 6, 2017 /PRNewswire/ — Joel M. Androphy and Sarah M. Frazier of the Berg & Androphy law firm, along with the U.S. Department of Justice (DOJ) and 50 state Medicaid programs plus the District of Columbia and the City of Chicago, have reached settlements in False Claims Act (FCA) litigation against Novo Nordisk and their subsidiaries.
Their case, filed on behalf of the U.S. government by the first of multiple whistleblowers to bring suit on similar allegations, charged that Novo Nordisk illegally marketed Victoza and profited from its alleged deception through fraudulently garnered reimbursement from Medicare Part D and Medicaid. The Food and Drug Administration (FDA) approved Victoza in January of 2010 for the adjunct treatment of Type 2 diabetes. It carries a so-called black box warning concerning the risk of medullary thyroid cancer.
The settlement encompasses allegations that upon product launch, Novo Nordisk downplayed Victoza’s risk of causing medullary thyroid cancer, creating a false or misleading impression with physicians that the Risk Evaluation and Mitigation Strategies (REMS) safety warning that had been mandated by the FDA was erroneous, irrelevant, or unimportant. The settlement encompasses the further allegations that Novo Nordisk encouraged the sale and use of Victoza by adult patients who did not have Type 2 diabetes.
In resolving its liability, Novo Nordisk agreed to pay the United States and the States a total sum of $46.5 million for the release of False Claims Act claims covering the conduct alleged by the suits against the company. Novo Nordisk has also agreed to pay $12.15 million to settle alleged violations of the Federal Food, Drug, and Cosmetic Act (FDCA).
Ms. Frazier noted, “REMS programs are meant to keep patients safe by ensuring that physicians have full and accurate information about important safety risks. This is a groundbreaking settlement because it makes clear that the False Claims Act is violated when pharmaceutical manufacturers undermine a REMS program and misbrand a drug by downplaying the risk of adverse effects.”
The settlement provides a grave warning to drug companies that this conduct is not only illegal but will be pursued by with vigor by the Department of Justice and concerned whistleblowers alike. Berg & Androphy is proud to represent the whistleblower that first came forward at great personal risk in 2010 to bring this conduct to light.
The case is United States of America v. Novo A/S, et al., No. 13-1529 in the United States District Court for the District of Columbia.
About Berg & Androphy
Berg & Androphy, based in Houston, Texas, with offices in New York, and by appointment in Washington, D.C., Denver, and Miami, has a nationwide qui tam practice representing whistleblowers in many large fraud cases, including health care, real estate, financial fraud, and defense contractor fraud cases. The lawyers at Berg & Androphy are trial lawyers who are currently litigating numerous qui tam lawsuits without government intervention. Joel Androphy and Sarah Frazier supervise a team of trial lawyers in this practice area.
Contact: Sarah Frazier and Joel Androphy, Berg & Androphy, 713.529.5622.