Murphy Anderson Represents False Claims Act Whistleblowers in Groundbreaking $58.7 Fraud Settlement
Thanks to persevering False Claims Act qui tam whistleblowers and innovative lawyering by Murphy Anderson PLLC lawyers, the False Claims Act now prohibits unsafe drug marketing tactics in violation of the REMS Law. In a first-of-its-kind settlement, Novo Nordisk, Inc., a Danish company, agreed to pay $58.7 million, the Department of Justice (DOJ) announced today.
The settlement resolves whistleblower and regulatory claims that Novo Nordisk did not comply with safety communications required by the federal Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategies (REMS) law. The FDA conditioned its approval of Victoza, a synthetic insulin for diabetes, upon Novo Nordisk's compliance with REMS.
The settlement ends claims by former Novo Nordisk sales representatives, including those represented by Murphy Anderson lawyers Mark Hanna and Ann Lugbill, that Novo Nordisk defrauded federal Medicare, Veterans Administration, employee insurance and state Medicaid programs. The whistleblower suit alleged that doctors prescribed Victoza without adequate knowledge of safety issues. The Murphy Anderson whistleblowers alleged that Novo Nordisk, in order to maximize sales, failed to adequately inform prescribers of Victoza's medullary thyroid cancer risks.
The case demonstrates that the Civil War-era False Claims Act can be used to penalize pharmaceutical companies that use slick marketing tactics to avoid mandatory drug safety warnings and patient protections required by REMS. REMS was enacted by Congress in 2007 amidst an avalanche of media reports that pharmaceutical companies hid potential risks of harmful or fatal adverse drug effects. REMS requires manufacturers to conduct risk evaluation and mitigation efforts that are individually tailored for each drug and the specific risks of each drug. REMS mandates that drug companies engage in ongoing action to study potential drug hazards and warn doctors and patients of risks.