© Reuters.
DUBLIN – Endo International plc (OTC: OTC:) has reached an agreement to settle U.S. Department of Justice (DOJ) investigations into the marketing of its opioid painkiller Opana ER by its subsidiary, Endo Health Solutions Inc. (EHSI), the company announced today.
The settlement includes a guilty plea to a misdemeanor charge related to marketing practices from April 2012 to May 2013 and resolves civil claims without an admission of liability.
The payments connected with the DOJ resolutions will align with the terms of a global settlement-in-principle outlined in Endo’s proposed Plan of Reorganization, which was initially filed on December 19, 2023. The Plan is part of the company’s ongoing financial restructuring efforts.
EHSI’s guilty plea pertains to a single strict liability misdemeanor for misbranding under the Federal Food, Drug, and Cosmetic Act.
Despite the plea, the civil settlement does not include any admission of liability or wrongdoing by EHSI. Endo has emphasized its cooperation with the DOJ investigations and has taken steps to enhance its U.S. compliance program since 2013.
The company has undergone significant changes to its policies, training, and risk management procedures. Additionally, as part of its restructuring process, Endo agreed to a Voluntary Operating Injunction in November 2022, which will remain effective until August 2030.
Endo’s proposed Plan of Reorganization, inclusive of the DOJ settlement, is pending approval from the Bankruptcy Court. A hearing to confirm the Plan is scheduled for March 19, 2024. The company has stated that the DOJ resolutions do not impose new compliance obligations on entities that may purchase the company’s assets post-restructuring.
This announcement is based on a press release statement from Endo International plc.
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