Endo reaches resolution with DOJ regarding legacy marketing of Opana ER
Endo’s subsidiary, Endo Health Solutions, has agreed to resolve all issues regarding previously disclosed U.S. Department of Justice investigations of EHSI and other company subsidiaries related to certain legacy marketing of Opana ER. The company voluntarily stopped marketing Opana ER directly to U.S. healthcare providers in 2016 and stopped selling Opana ER in 2017.
Payments to be made in connection with the DOJ resolutions will be made in accordance with the previously disclosed global economic settlement-in-principle, which also resolves claims from the Internal Revenue Service, included in the company's proposed Plan of Reorganization originally filed on Dec.19, 2023.
As part of the DOJ resolutions, EHSI agreed to plead guilty to a single strict liability misdemeanor misbranding violation of the Federal Food, Drug, and Cosmetic Act related to certain Opana ER marketing occurring between April 2012 and May 2013. EHSI also agreed to resolve the DOJ's civil investigation of the sales and marketing of Opana ER. The civil settlement does not include any admission of liability or wrongdoing by EHSI. The Company has cooperated with each of the DOJ's investigations.
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Since 2013, Endo has proactively strengthened its U.S. compliance program, including by adopting new policies, enhancing others and developing additional training and risk management procedures. In addition, as part of its restructuring proceedings, the company agreed to a Voluntary Operating Injunction in November 2022 that continues through August 2030. The company said it remains committed to operating with integrity and maintaining a culture of compliance and ethics. The DOJ resolutions do not subject post-emergence purchaser entities to additional compliance-related or integrity obligations.
Endo submitted the DOJ resolutions to the Bankruptcy Court for approval, which Endo is seeking in conjunction with its proposed Plan of Reorganization. A hearing to consider confirmation of the proposed Plan of Reorganization is currently scheduled for March 19, 2024.
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