Amneal to pay over $270M for role in opioid crisis

New York Attorney General Letitia James on Friday announced a multistate settlement in principle with opioid manufacturer Amneal for its role in fueling the nationwide epidemic of opioid addictions and overdoses. 

Amneal produces several generic opioid products and was one of the largest manufacturers of opioids from 2006 to 2019, selling nearly nine billion pills. Attorney General James and a multistate coalition of attorneys general allege that Amneal knowingly failed to monitor and report suspicious orders placed by its customers, as it was required to by federal law, per the Attorney General's office. 

“Amneal became one of the largest generic pharmaceutical companies in the world by profiting off the sale of dangerous opioids,” said Attorney General James. “While this settlement can’t fully reverse the damage done as a result of the national crisis, it will provide essential funding and resources for New York and other states to ensure those suffering get the help they need. I am proud to have secured over $2.7 billion to tackle the opioid epidemic in New York, and my office will continue to hold accountable the companies responsible for fueling this crisis.” 

[Read more: Teva to pay New York State $523M over alleged role in opioid crisis]

The settlement in principle announced May 3, 2024 will provide $92.5 million in cash over 10 years and $180 million worth of naloxone nasal spray, an overdose treatment medication, to participating states and local governments. 

The settlement in principle was negotiated by Attorney General James and the attorneys general of California, Delaware, Tennessee, Utah and Virginia. 

In 2019, Attorney General James filed the nation’s most extensive lawsuit against opioid distributors and manufacturers for their role in the opioid epidemic. Since then, Attorney General James has recovered more than $2.7 billion to support New York opioid abatement, treatment and prevention efforts from companies including Hikma Pharmaceuticals, Publicis Health, Teva Pharmaceuticals, Johnson & Johnson, Mallinckrodt, Allergan, Endo, McKesson, Cardinal Health and Amerisource Bergen. 

Attorney General James also has led multistate coalitions in reaching settlements for billions of dollars with CVS, Walgreens and Walmart for their role in failing to properly regulate opioid prescriptions. Additionally, Attorney General James, co-led a coalition of nearly every attorney general in the nation in delivering more than $573 million—more than $32 million of which was earmarked for New York state—toward opioid treatment and abatement in an agreement and consent judgment with McKinsey & Company.

[Read more: Walgreens reaches $230M opioid settlement with San Francisco]

This settlement with Amneal was negotiated on behalf of New York by First Deputy Attorney General Jennifer Levy and Assistant Attorney General Matthew Conrad of the Executive Division, with assistance from Data Scientist Ken Morales and Acting Deputy Director of Research and Analytics Gautam Sisodia of the Research and Analytics Department, Assistant Attorney General Eve Woodin of the Health Care Bureau, and Special Counsel Monica Hanna of the Executive Division. 

In a press release reporting its first quarter 2024 financial results, Amneal said it has reached a settlement in principle on the primary financial terms, with no admission of wrongdoing, for a nationwide resolution to the opioids cases that have been filed and that might have been filed against the company by states, counties, municipalities and Native American Tribal Nations across the United States. 

"The settlement in principle resolves substantially all opioids litigation and is subject to the negotiation and execution of a definitive settlement agreement between the parties. The settlement would be payable over ten years. Under the settlement, the company would agree to pay $92.5 million in cash and provide $180.0 million in naloxone nasal spray (valued at $125 per two-pack) to help treat opioid overdoses," Amneal said.

Amneal continued, "In lieu of receiving product, the settling parties can opt to receive 25% of the product value (up to $45 million) in cash during the last four years of the ten-year payment term. In the first quarter of 2024, the company recorded a charge of $94 million in the consolidated statement of operations based on full participation in the potential settlement, which reflects the value of the cash payments and the supply of naloxone nasal spray over the ten-year period. The settlement in principle is contingent upon a sufficient number of settling parties electing to opt into the final definitive agreement. We remain committed to helping those impacted by the opioid crisis by enhancing access to naloxone nasal spray, which is an emergency treatment for opioid overdose and helps save lives."