Overview of the Litigation
The National Prescription Opiate Litigation, also known as MDL 2804, is a multidistrict litigation (MDL) case consolidated in the U.S. District Court for the Northern District of Ohio under Judge Dan Aaron Polster. This litigation involves numerous lawsuits filed by counties, cities, towns, and Native American tribes against opioid manufacturers, distributors, and pharmacies for the harms caused by the abuse and misuse of prescription opioids[2][4].
History of the Litigation
In early 2017, various local and tribal governments across the U.S. initiated lawsuits against opioid manufacturers and distributors. By December 2017, the U.S. Judicial Panel on Multidistrict Litigation consolidated nearly 200 pending opioid-related cases into this MDL[2].
Defendants and Allegations
The defendants in this litigation include major opioid manufacturers such as Actavis, Allergan, Cephalon, Endo, Janssen, Johnson & Johnson, Purdue Pharma, Teva, and Watson. Distributors like AmerisourceBergen, McKesson Corp., and Cardinal Health, collectively known as the "Big Three," are also defendants. Additionally, pharmacy chains like CVS, Rite-Aid, Walgreens, and Walmart have been implicated as distributors of pharmaceuticals to their retail pharmacies[2].
The common allegations are that manufacturers overstated the benefits and downplayed the risks of prescription opioids, engaging in aggressive marketing to physicians. Distributors and pharmacies are accused of failing to monitor, investigate, and report suspicious orders of prescription opioids, thereby violating the Controlled Substances Act and similar state laws[2][4].
Key Claims and Theories
Public Nuisance Claims
Plaintiffs assert that the oversupply of prescription opioids and their diversion into the illicit market constitute a public nuisance under Ohio statutory and common law. This claim is based on the argument that the defendants' actions caused a significant and ongoing interference with the public right to health and safety[3].
Conspiracy Claims
Plaintiffs also allege conspiracy among the defendants, suggesting that they collectively engaged in fraudulent marketing and failed to maintain effective controls against opioid diversion[3].
Fraudulent Marketing Claims
Manufacturers are accused of engaging in widespread promotional and marketing campaigns that trivialized the risks of addiction and exaggerated the benefits of long-term opioid use. Plaintiffs present extensive evidence to support these claims, including expert reports and internal company documents[3].
Failure to Maintain Effective Controls
Distributors and pharmacies are alleged to have failed to monitor and report suspicious orders, which contributed to the opioid epidemic. Plaintiffs argue that these failures were a substantial factor in producing the harm suffered by the plaintiffs[3].
Significant Rulings and Orders
Jury Verdict
In November 2021, after a six-week trial, the jury found in favor of the plaintiffs against CVS, Walmart, and Walgreens. The jury concluded that the oversupply of prescription opioids and their diversion into the illicit market constituted a public nuisance in Lake and Trumbull Counties, and that each defendant engaged in intentional and/or illegal conduct that substantially contributed to this nuisance[1].
Abatement Costs and Injunction
The court ordered the pharmacy defendants to pay for abatement programs aimed at mitigating the opioid crisis. However, the court reduced the costs to account for programs that were not directly related to abating the opioid nuisance and for opioid addiction that would have occurred regardless of the defendants' actions. The court also appointed an administrator to oversee the Abatement Fund and directed the pharmacy defendants to comply fully with the Controlled Substances Act to prevent further improper dispensing[1].
Summary Judgment Motions
The court denied summary judgment motions filed by the defendants, finding that plaintiffs had presented sufficient evidence to demonstrate causation between the defendants' actions and the harm suffered. The court rejected the defendants' arguments that plaintiffs could not show proximate causation between the alleged marketing misconduct and the increase in opioid prescriptions[3].
Settlements and Negotiations
In 2021 and 2022, nationwide settlements were reached to resolve the opioids litigation brought by states and local governments against the three largest distributors (AmerisourceBergen, McKesson Corp., and Cardinal Health) and several manufacturers. These settlements were facilitated by Judge Dan Polster, the court-appointed Plaintiffs’ Executive Committee, and neutral mediators. However, these agreements do not settle claims brought by tribes or private parties[5].
Impact and Implications
The National Prescription Opiate Litigation has significant implications for public health policy, pharmaceutical regulation, and corporate accountability. The rulings and settlements underscore the importance of stringent controls on opioid distribution and the need for accurate and transparent marketing practices in the pharmaceutical industry.
Key Takeaways
- Consolidation of Cases: The litigation involves the consolidation of nearly 200 cases against opioid manufacturers, distributors, and pharmacies.
- Public Nuisance Claims: Plaintiffs argue that the oversupply and diversion of opioids constitute a public nuisance.
- Fraudulent Marketing: Manufacturers are accused of misleading marketing practices that downplayed the risks of opioids.
- Failure to Monitor: Distributors and pharmacies are alleged to have failed to monitor and report suspicious orders.
- Jury Verdict and Abatement: The jury found in favor of the plaintiffs, and the court ordered abatement programs with reduced costs.
- Settlements: Nationwide settlements have been reached with major distributors and manufacturers, but do not include claims by tribes or private parties.
FAQs
What is the National Prescription Opiate Litigation?
The National Prescription Opiate Litigation is a multidistrict litigation case involving lawsuits against opioid manufacturers, distributors, and pharmacies for the harms caused by the abuse and misuse of prescription opioids.
Who are the defendants in this litigation?
The defendants include major opioid manufacturers, distributors like AmerisourceBergen, McKesson Corp., and Cardinal Health, and pharmacy chains like CVS, Rite-Aid, Walgreens, and Walmart.
What are the main allegations against the defendants?
The main allegations are that manufacturers overstated the benefits and downplayed the risks of opioids, and distributors and pharmacies failed to monitor and report suspicious orders, contributing to the opioid epidemic.
What was the outcome of the jury trial in 2021?
The jury found in favor of the plaintiffs, concluding that the oversupply and diversion of opioids constituted a public nuisance and that the defendants engaged in intentional and/or illegal conduct contributing to this nuisance.
What are the implications of the settlements reached in 2021 and 2022?
The settlements highlight the need for stringent controls on opioid distribution and accurate marketing practices in the pharmaceutical industry, and they provide financial resources for abatement programs aimed at mitigating the opioid crisis.
Do the settlements include claims by tribes or private parties?
No, the settlements do not settle or release any claims brought by tribes or private parties, including private individuals, hospitals, or third-party payers.
Sources
- In re: National Prescription Opiate Litigation, U.S. District Court for the Northern District of Ohio, 2024.
- National Prescription Opiate Litigation, Industry Documents Library.
- In re: National Prescription Opiate Litigation, U.S. District Court for the Northern District of Ohio, 2019.
- MDL 2804, Northern District of Ohio, United States District Court.
- Executive Summary – National Opioids Settlement, 2024.
