Opana ER was first released in 2006 and was reformulated in 2012 with purported abuse deterrent and tamper resistant technology. The U.S. Food and Drug Administration (FDA) determined that the data did not show a meaningful reduction in non-medical use and declined to allow abuse deterrence and tamper resistance claims in its labeling. In 2014, the U.S. Department of Justice (DOJ) began a probe into Opana ER following whistleblower allegations of mislabeling but withdrew the case in 2015.
In June 2017, the FDA recommended the removal of Opana ER from the market due to risks related to non-medical use and its potential to cause a rare blood disorder, thrombotic microangiopathy, when used intravenously. Endo subsequently removed it from the market.
The company was a defendant in thousands of lawsuits filed by state and local governments, Native American tribes, and individuals against the opioid industry. The plaintiffs accused the company of contributing to the deadly opioid crisis by misrepresenting safety claims for its opioid drugs.
In August 2022, Endo initiated Chapter 11 proceedings in New York. The DOJ renewed its investigation, and in February 2024, it announced a global resolution of criminal and civil investigations against Endo, which allowed the company to move forward with its bankruptcy. Endo acknowledged that from April 2012 to May 2013, certain sales representatives promoted Opana ER as an abuse deterrent opioid, despite no clinical evidence supporting these claims. The resolution also settled allegations that from 2011 to 2017, Endo marketed Opana to prescribers for non-medically indicated uses and ignored or minimized red flags for prescribers engaged in diversion and egregious overprescribing. As part of the agreement, Endo affiliates are restrained indefinitely in opioid marketing and sales, and documents related to the company’s role in the opioid crisis must be publicly disclosed.
Endo announced a proposed merger with Mallinckrodt Pharmaceuticals in March 2025.
The records in this collection are subject to public disclosure under the terms of a Voluntary Operating Injunction with Endo. The University of California San Francisco and Johns Hopkins University have been appointed to serve as the public repository for these documents. Documents in the collection include emails, spreadsheets, presentations, regulatory submissions, labeling, conference materials, internal memoranda, Speaker’s Bureau documentation, employee incentive structures and performance, Opana ER launch information, reports from Wolters Kluwer Health (an information services company), and materials related to Par Pharmaceuticals.
Endo employees and others frequently appearing in the documents include: Nancy Alverez, Bob Barto, Demir Bingol, Steven Camper, Tara Chapman, Angela Feniger, Errol Gould, Sandeep Gupta, Kevin Hickey, Rich Karelas, David Kerr, Todd Kirby, Linda Kitlinski, Diana McGuire, Misty McKay, Steven Passik, Gregory Pyszczymuka, Neil Shusterman, Oksana Terleckyj, Heather Thomson, Vincente Tormo, Kristin Vitanza, Lisa Walker, and Matthew Wieman.
Endo has redacted protected information in the documents (including personally identifiable information (PII) and protected health information (PHI)) according to the disclosure terms of the agreement. OIDA team members reviewed a sample of the documents to verify appropriate redaction of PII and PHI, adding additional redactions when warranted.
List of Lawsuits
Bankruptcy case background, cooperation agreement, and terms sheet
Terms of public disclosure
Settlement agreement
Criminal plea agreement
