New York files insurance fraud claim against Endo Pharmaceuticals.
Governor Andrew M. Cuomo announced the New York State Department of Financial Services (DFS) has filed charges against Endo International plc and its subsidiaries, Endo Health Solutions Inc., Endo Pharmaceuticals, Inc., and Par Pharmaceutical Companies, Inc.
“All these opioid manufacturers knew how addictive and dangerous their products were, and they used it as a reckless business model for their own financial gain at the cost of thousands of human lives and billions of dollars. New York demands accountability from the drug companies and others responsible for the opioid epidemic that continues to devastate families and communities throughout the state and across the country,” Governor Cuomo said. “Their greedy, fraudulent behavior is inexcusable, and New York will make sure that justice is served and these big pharmaceutical companies are ultimately held responsible for their actions.”
According to DFS’ Statement of Charges, Endo “has been a prolific manufacturer of opioids in the United States, manufacturing approximately 18.4 percent of the opioids that flooded New York from 2006 to 2014. Endo manufactured both its own branded opioids as well as generic opioids.”
The statement also alleges that Endo “knowingly furthered a false narrative to legitimize opioids as appropriate for broad treatment of pain by downplaying their long-known addictive nature and risks. This strategic effort caused a shift in medical providers’ and patients’ acceptance of opioids as medically legitimate, necessary and appropriate painkillers. As a result, demand soared, as did the predictable negative consequences;
Misrepresented the safety and efficacy of opioids, without legitimate scientific substantiation, in a panoply of materials typically used by the medical community and patients, including marketing and promotional materials, educational publications, and medical literature published by associations and key opinion leaders funded and supported by Endo, and;
Deployed a large sales force to target healthcare providers directly with these misrepresentations. Indeed, Endo’s representatives made at least 165,000 sales calls just in New York to market its branded opioid, Opana ER, over just a four-year period.”
The department has further alleged that “Endo repeatedly marketed a reformulated version of Opana as abuse-resistant without having a legitimate basis for such a claim.” At the same time, the company’s own internal documents showed that the new product remained subject to abuse. Despite that, Endo continued to market the new formulation as safer and less likely to be abused than its older product and comparable generics.”
“FDA’s drug approval process is designed to ensure that companies market their products for uses that are proven to be safe and effective,” said Assistant Attorney General for the Justice Department’s Civil Division Stuart F. Delery. “We will hold accountable those who circumvent that process in pursuit of financial gain.”
“The safety and efficacy of drugs must be shown by science, not sales pitches,” said U.S. Attorney for the Northern District of New York Richard S. Hartunian. “Drugs marketed for intended uses not approved by the FDA are misbranded.”
In January of this year, Endo agreed to pay $8.8 million to settle claims brought by Oklahoma alleging deceptive marketing practices contributing to the opioid crisis.