Insys Litigation Documents

  

Date Range: 2000-2019; bulk 2012-2017

Overview and Background

Founded in 1990 and incorporated in 2002, Insys Therapeutics found success in a niche of the opioid market selling transmucosal immediate-release fentanyl (TIRF) medications, which are intended for "breakthrough" pain in cancer patients already taking other opioid painkillers. Subsys, the company’s patented spray-delivery TIRF, was launched in 2012; prescriptions for Subsys amounted to about $330 million dollars in net revenue for Insys in 2015.

The U.S. Department of Health and Human Services Office of Inspector General investigated Insys in 2013 for its sales and marketing practices, after a former Insys employee filed a whistleblower suit. Arrests of physicians writing high numbers of Subsys prescriptions prompted further investigation of Insys. States, counties, cities and individuals sued Insys, with many suits being consolidated into a multidistrict case. Federal investigations culminated in a 2019 federal criminal trial against top Insys executives, in which the company’s founder, Dr. John Kapoor, and four other executives were found guilty of racketeering conspiracy. Kapoor became the first opioid industry CEO sentenced to prison.

In June 2019 Insys agreed to a $225 million settlement to resolve federal criminal and civil cases against the company. The company filed for bankruptcy, sold the Subsys license to another pharmaceutical company, and stopped selling drugs in 2019. Insys was the first opioid company to seek bankruptcy protection as a result of legal action related to the opioid crisis.

The documents in this collection come from U.S. District Court records (District of Massachusetts, Boston), MDL 2804 (multidistrict litigation) and from investigation by the New York State Office of the Attorney General.

Documents

Documents include: 45 volumes of transcripts from the trial; internal sales training materials, sales rep data, and compensation strategies; submissions to regulatory agencies regarding consumer guides, brochures, and prescribing information; graphics designs for product packaging and labeling; brochures and prescribing publications intended for physicians and the general public; advertisements and marketing materials; correspondence with prescribers who were part of the Insys "Speakers Bureau."

The Opioid Industry Documents Archive (OIDA) contracted with a legal review company to redact documents for PII and PHI according to OIDA’s redaction protocols, and OIDA team members reviewed a sample of the documents to verify appropriate redaction of PII and PHI. A small portion of the documents were redacted by OIDA team members rather than the legal review company.

Where to Start...

Timeline of Events
Selected Case-Specific Documents
Key Actors

Key Legal Documents

Background of bankruptcy case
Case docket
Transcripts of the 2019 federal racketeering trial
August 2022 agreement outlining the terms of Insys’s document release
Search terms used to produce documents in the multidistrict litigation between Jan. 1,1998, and Dec. 31, 2017

Notable Insys Documents and Related Topics

Insurance Reimbursement Center (IRC)
Aggressive Sales Culture
Insys Speaker Programs
Relying on "Whales" and Repurposing REMS
Sales Call Notes
Disregarding the Dangers of Subsys
Diversion and Pharmacy Distribution

Related Resources

• Alltucker, K. (2022, Dec 8). 'Eat what you kill': How a fentanyl drugmaker bribed doctors, harmed patients and collected millions. USA Today. (registration may be required)
• Hughes, E. (2022). The Hard Sell: Crime and Punishment at an Opioid Startup.
• Frontline. (2021, June 23). “Opioid, Inc.”. PBS.
• Brickley, P. (2020, January 16). Opioid Maker Insys Wins Court Approval of Bankruptcy Plan. Wall Street Journal. (registration may be required)
• Romo, V. (2019, June 10). Insys Files For Chapter 11, Days After Landmark Opioid Settlement Of $225 Million. NPR.
• Office of the New York State Attorney General. (2018, Feb. 1). A.G. Schneiderman Sues Fentanyl Maker Insys Therapeutics, Inc. For Dangerous And Deceptive Promotion Of Prescription Opioid Subsys.
• U.S. Senate Homeland Security & Governmental Affairs Committee. (2015, December).Fueling an Epidemic: Inside the Insys Strategy for Boosting Fentanyl Sales.

See our annotated bibliography for more resources providing context of the Insys litigation.