The New York State Department of Financial Services has filed civil charges against drug maker Endo International Plc for misrepresenting the efficacy and safety of its opioid drugs and for insurance fraud. Endo manufactured 18.4% of the opioids distributed in New York between 2006 and 2014, including its drug Opana ER.
The Department of Financial Services said that Endo downplayed how addictive opioids like Opana ER really were. This led many people to feel a false sense of security about taking the medications for pain relief.
The regulator also accuses Endo of knowingly contributing to a “massive” surge in opioid prescriptions, which included medically unnecessary prescriptions and ultimately led to fraudulent insurance claims.
Endo had been selling a reformulated Opana ER until July 2017, when the FDA asked it to remove the drug from the market.
These charges are similar to those brought against Mallinckrodt Plc in April.
Misrepresentations led to violations of insurance law
“All these opioid manufacturers knew how addictive and dangerous their products were,” said a statement by Governor Andrew Cuomo’s office. “Their greedy, fraudulent behavior is inexcusable.”
The charges involve allegations that Endo violated two New York insurance laws when it misrepresented the safety and efficacy of the drugs. Civil penalties of $5,000 per violation are available, should the state win.
In a recent regulatory filing, Endo indicated that it is facing over 3,200 lawsuits in regard to its opioid drugs. Most of the lawsuits have been brought by cities, counties and municipalities.
Since 1997, opioid painkillers have contributed to over 400,000 deaths, according to the Centers for Disease Control and Prevention. Governments and individuals have struggled with how to hold the manufacturers responsible for the harm their drugs have done.
Although this is a regulatory enforcement action, a win by the state of New York against Endo and other manufacturers who misled patients about the safety of opioid drugs could be significant. It could provide significant evidence that the manufacturers acted improperly or even illegally. This, in turn, could allow families of those lost to opioid overdose some relief in the courts.
The Department of Financial Services has scheduled a hearing in the case for Oct. 26 in Albany.