Mallinckrodt Litigation Documents
Date Range: 1995-2019; bulk 2010-2015
Overview and Background
Founded in 1867 in St. Louis, Mo., Mallinckrodt Pharmaceuticals is a leading manufacturer of opioid
painkillers. Its subsidiary, SpecGx
, dominated the US market for generic opioids as addiction and
overdose rates spiked across the nation. According to DEA records, the company provided nearly 40%
of all opioid pills sold in US pharmacies between 2006-2012.
In 2011, Mallinckrodt came under investigation by the DEA
for failing to meet its requirements to track
and report suspicious orders of controlled substances. 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
trivializing addiction and failing to identify and report suspicious drug orders.
In October 2020, Mallinckrodt filed for bankruptcy in Delaware. A court-sanctioned agreement led to
the release of 1.4 million documents produced by the company in the litigation (In re: Mallinckrodt plc, Case No. 20-12522-JTD (Bankr. D. Del. 2020)
Documents include: Email communications between sales representatives, physicians and other healthcare representatives; 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 physicians; and other internal documents.
Documents were redacted for PII
by Mallinckrodt’s legal team. The Opioid Industry Documents Archive contracted with a legal review company to review a sample of the documents to verify appropriate redaction of PII and PHI.
Where to Start...
Key Legal Documents
Mallinckrodt Key Actors
Mallinckrodt Email Tracker
Notable Mallinckrodt Documents and Related Topics
Bankruptcy case background and case docket
Document release agreement and Mallinckrodt request to pause litigation cases
Search terms used to produce documents in the multidistrict litigation between Jan. 1,1998, and Dec. 31, 2017
Efforts to Undermine Health Insurance Restrictions
Pushing Sales to the Limit
Targeting High-Volume Prescribers
Mallinckrodt Speakers’ Program
Lobbying Against Regulation
Responding to Illegal Activity
Collecting Data on Downstream Sales
Creating Playbooks, Targeting Prescribers
Using Food to Gain Access to Prescribers
See our annotated bibliography for more resources providing context of the Mallinckrodt litigation.
- Higham, S. and Horwitz, S. (2022). American Cartel: Inside the Battle to Bring Down the Opioid Industry
- Kornfield, M., Higham, S., and Rich, S. (2022, May 10). Inside the sales machine of the ‘kingpin’ of opioid makers. The Washington Post. (registration may be required)
- Kaplan, S., and Hoffman, J. (2020, Feb 25.) Mallinckrodt Reaches $1.6 Billion Deal to Settle Opioid Lawsuits. The New York Times. (registration may be required)
- Mast, J. (2020, Oct 12). Drowning in litigation, Mallinckrodt becomes third opioid producer to file for bankruptcy. Endpoints News. (registration may be required)
- Isidore, C. (2020, Oct 12). Opioid maker Mallinckrodt files for bankruptcy. CNN Business.
- Office of the Minnesota Attorney General. (2020, Oct 12). Attorney General Ellison announces settlement with opioid manufacturer Mallinckrodt.
- Davis, A.C., Boburg, S., and O'Harrow Jr., R. (2019, July 27). Little-known makers of generic drugs played central role in opioid crisis, records show. The Washington Post. (registration may be required)