Litigation Details for In Re: National Prescription Opiate Litigation (N.D. Ohio 2022)

In Re: National Prescription Opiate Litigation (N.D. Ohio 2022)

Docket		Date Filed	2022-11-04
Court	District Court, N.D. Ohio	Date Terminated
Cause	28:1446 Petition for Removal- Personal Injury	Assigned To	Dan A. Polster
Jury Demand	Both	Referred To
Parties	AMERICAN GERIATRIC SOCIETY; MEDISCA, INC.; RITE AID HEADQUARTERS CORPORATION
Patents	10,001,469; 10,006,091; 10,021,369; 10,023,560; 10,023,608; 10,023,621; 10,030,051; 10,041,044; 10,046,000; 10,046,056; 10,047,033; 10,066,019; 10,086,005; 10,086,010; 10,114,012; 10,114,022; 10,115,021; 10,124,000; 10,155,002; 10,183,006; 10,183,012; 10,286,004; 10,323,004; 10,471,023; 10,792,279; 11,020,388; 11,027,031; 11,141,457; 11,844,858; 12,005,042; 12,005,141; 12,168,022; 3,990,699; 4,015,026; 4,149,723; 4,325,717; 4,850,305; 5,001,048; 5,164,002; 5,294,005; 5,317,017; 5,670,678; 6,007,440; 6,028,222; 6,106,864; 6,200,604; 6,297,014; 6,417,175; 6,472,006; 6,488,963; 6,545,040; 6,552,004; 6,602,911; 6,649,180; 6,667,050; 6,893,662; 6,906,055; 6,913,768; 6,958,326; 6,992,218; 7,014,098; 7,030,149; 7,163,931; 7,192,938; 7,304,036; 7,320,969; 7,320,976; 7,371,727; 7,410,957; 7,419,973; 7,642,258; 7,645,459; 7,645,460; 7,668,730; 7,704,947; 7,704,984; 7,718,634; 7,741,358; 7,745,409; 7,765,106; 7,765,107; 7,790,199; 7,803,838; 7,829,121; 7,834,020; 7,838,552; 7,851,482; 7,888,342; 7,895,059; 7,935,008; 7,947,739; 7,994,220; 8,006,698; 8,008,338; 8,022,036; 8,022,054; 8,022,064; 8,022,082; 8,022,106; 8,022,228; 8,038,988; 8,039,009; 8,058,291; 8,080,526; 8,084,039; 8,101,593; 8,110,553; 8,133,890; 8,168,209; 8,173,708; 8,183,002; 8,193,195; 8,207,215; 8,217,083; 8,236,804; 8,242,294; 8,246,989; 8,263,054; 8,273,795; 8,283,379; 8,293,794; 8,309,060; 8,309,122; 8,329,216; 8,329,752; 8,330,006; 8,338,485; 8,338,486; 8,344,007; 8,344,011; 8,354,409; 8,362,002; 8,362,085; 8,367,649; 8,377,982; 8,395,021; 8,436,008; 8,436,051; 8,457,988; 8,461,140; 8,481,598; 8,486,972; 8,486,973; 8,541,466; 8,546,367; 8,580,858; 8,589,182; 8,598,233; 8,629,111; 8,632,760; 8,633,162; 8,642,556; 8,648,048; 8,653,058; 8,664,215; 8,673,921; 8,685,930; 8,692,008; 8,731,963; 8,748,425; 8,748,573; 8,758,733; 8,772,306; 8,802,628; 8,808,737; 8,808,741; 8,846,100; 8,865,937; 8,871,779; 8,883,770; 8,894,987; 8,894,988; 8,906,950; 8,906,962; 8,926,953; 8,933,030; 8,946,281; 8,986,715; 9,010,323; 9,020,056; 9,024,034; 9,040,034; 9,040,049; 9,050,302; 9,056,057; 9,060,976; 9,073,933; 9,081,016; 9,173,857; 9,175,009; 9,175,017; 9,216,183; 9,226,931; 9,242,011; 9,248,191; 9,302,002; 9,302,009; 9,352,016; 9,375,013; 9,399,012; 9,399,025; 9,486,426; 9,492,389; 9,492,391; 9,492,392; 9,492,393; 9,517,219; 9,522,155; 9,522,919; 9,555,001; 9,579,270; 9,604,009; 9,636,349; 9,694,008; 9,708,371; 9,770,453; 9,907,801; 9,907,802; 9,949,986; 9,957,480; RE43,879
Attorneys	Eric R. Delinsky; Jill G. Okun; Lisa M. Saltzburg
Firms	Bass Berry & Sims; Kay Casto & Chaney; Spangenberg, Shibley & Liber LLP
Link to Docket	External link to docket

Biologic Drugs cited in In Re: National Prescription Opiate Litigation

Details for In Re: National Prescription Opiate Litigation (N.D. Ohio 2022)

Date Filed	Document No.	Description	Snippet	Link To Document
2022-11-04				External link to document
2022-11-04	1717	Exhibit s to Chalos Declaration	infringed U.S. Patent Nos. 6,028,222 ("the '222 patent") and 6,992,218 ("the '…concerning ten patents covering Inomax (i.e., five patents expiring in 2029 and five patents expiring in…in the five patents expiring in 2031 are patentable. '222 and '218 Patent Litigation:… such investigation. Patent/Antitrust Litigation Inomax Patent Litigation: Praxair Distribution…this group of patents and the PTAB ruled in July 2016 that one claim of this patent survived review	External link to document
2022-11-04	1812	Exhibit 16 - Chalos Dec.:MNK 2016 10Q	infringed U.S. Patent Nos. 6,028,222 ("the '222 patent") and 6,992,218 ("the '…concerning ten patents covering Inomax (i.e., five patents expiring in 2029 and five patents expiring in…in the five patents expiring in 2031 are patentable. '222 and '218 Patent Litigation:… such investigation. Patent/Antitrust Litigation Inomax Patent Litigation: Praxair Distribution…this group of patents and the PTAB ruled in July 2016 that one claim of this patent survived review	External link to document
2022-11-04	1823	Exhibits 1-37 [redacted] to the Egler Declaration	Warner Chilcott’s U.S. Patent No. 6,893,662, expiring in November 2021 (the “‘662 Patent”), is invalid and/…) U.S. Patent No. 5,541,170 (the “‘170 Patent”) and U.S. Patent No. 5,541,171 (the “‘171 Patent”), formulation…Chilcott’s U.S. Patent Nos. 7,645,459 (the “‘459 Patent”) and 7,645,460 (the “‘460 Patent”), two formulation…infringement of the ‘459 Patent and ‘460 Patent. On August 21, 2012, the United States Patent and Trademark Office…to the Company U.S. Patent No. 8,246,989 (the “‘989 Patent”), a formulation patent expiring in January	External link to document

Litigation Summary and Analysis for In Re: National Prescription Opiate Litigation

Last updated: July 14, 2025

Introduction

The opioid crisis has reshaped public health and legal landscapes in the United States, with In Re: National Prescription Opiate Litigation (MDL No. 2804) standing as a landmark case. Filed in 2017, this multidistrict litigation consolidates thousands of lawsuits against major pharmaceutical companies, distributors, and pharmacies. These entities face allegations of fueling the epidemic through deceptive marketing, inadequate oversight, and failure to curb oversupply. As a drug patent analyst, this case offers critical insights into how litigation can disrupt industry practices, influence regulatory frameworks, and impact corporate strategies in pharmaceuticals.

Background of the Case

In Re: National Prescription Opiate Litigation began in the Northern District of Ohio, where it was consolidated under MDL 2804 to streamline proceedings. Plaintiffs, including state and local governments, Native American tribes, and healthcare providers, accuse defendants of violating federal and state laws. Key targets include opioid manufacturers like Purdue Pharma, Johnson & Johnson, and Teva Pharmaceuticals, as well as distributors such as McKesson and Cardinal Health, and pharmacy chains like Walgreens and CVS.

The litigation stems from the aggressive promotion of prescription opioids in the late 1990s and early 2000s. Companies allegedly downplayed addiction risks and overstated benefits, leading to widespread overprescription. According to court filings, this contributed to over 500,000 opioid-related deaths between 1999 and 2019, as reported by the Centers for Disease Control and Prevention. Plaintiffs seek billions in damages for public health costs, including treatment programs and law enforcement expenses.

Key Events and Developments

The case has unfolded through a series of pivotal rulings and settlements. In 2019, a federal judge approved a $260 million settlement with Teva Pharmaceuticals and several other companies, marking one of the first major resolutions. This deal required Teva to donate generic naloxone, an opioid overdose reversal drug, to combat the crisis.

High-profile trials followed in 2021, with Ohio counties securing a $260 million verdict against Walmart, CVS, and Walgreens for failing to monitor suspicious orders. Jury decisions highlighted distributors' negligence in adhering to the Controlled Substances Act, which mandates tracking and reporting of opioid shipments. Purdue Pharma, perhaps the most scrutinized defendant, filed for bankruptcy in 2019 amid over 2,000 lawsuits. Its 2021 bankruptcy plan proposed an $8.3 billion settlement, but appeals delayed finalization until 2022, when the U.S. Supreme Court rejected a key aspect, forcing renegotiations.

By 2023, cumulative settlements exceeded $50 billion, including a $5 billion agreement from Johnson & Johnson and a $21 billion commitment from the three largest distributors. These outcomes underscore the litigation's role in extracting corporate accountability, with funds allocated for addiction treatment and prevention programs.

Legal Analysis

From a pharmaceutical perspective, this litigation exposes vulnerabilities in drug marketing and distribution chains. Companies often relied on patents to protect opioid formulations, such as Purdue's extended-release OxyContin, patented in the 1990s. However, plaintiffs argue that patent strategies enabled monopolistic pricing and aggressive promotion, exacerbating the crisis. For instance, Purdue's patents on abuse-deterrent opioids faced challenges, revealing how intellectual property can intersect with public health risks.

The case also scrutinizes the Drug Enforcement Administration's (DEA) quota system for controlled substances. Distributors breached these quotas, leading to oversupply, which courts interpreted as willful misconduct. This analysis reveals potential reforms, such as tighter patent office scrutiny of drugs with high abuse potential and enhanced FDA oversight of marketing claims.

Legally, the MDL framework expedited proceedings, allowing plaintiffs to consolidate evidence and negotiate bulk settlements. Defendants countered with arguments of preemption, claiming federal regulations shielded them from state-level lawsuits. Courts largely rejected this, affirming that state tort laws could address deceptive practices. For business professionals, this signals heightened litigation risks for pharma firms, particularly those with patented products in regulated categories.

Current Status and Ongoing Implications

As of mid-2024, MDL 2804 continues with unresolved claims, though many defendants have settled. The U.S. Department of Justice monitors remaining cases, ensuring settlements align with public interest. Recent developments include appeals over settlement distributions, with some states challenging fund allocations.

The litigation's ripple effects extend to industry operations. Pharmaceutical companies now face stricter compliance requirements, including advanced tracking systems for opioid distribution. This could raise operational costs and delay new drug approvals, as firms prioritize risk assessments in patent filings. For investors, the case highlights the need to evaluate litigation exposure when assessing pharma stocks, potentially influencing mergers and acquisitions in the sector.

Impact on Stakeholders

Governments and taxpayers benefit most from settlements, with funds directed toward opioid abatement. For example, Ohio's $1.5 billion from various deals supports rehab centers and education campaigns. Conversely, defendants endure financial strain and reputational damage, prompting shifts in corporate governance. Johnson & Johnson's decision to spin off its consumer health division partly reflects this pressure.

Healthcare providers and patients grapple with mixed outcomes. While settlements aim to improve access to treatment, ongoing supply chain disruptions could limit legitimate pain management options. Patent analysts should note how this case accelerates generic competition, as expiring opioid patents face heightened scrutiny, potentially fostering innovation in non-addictive alternatives.

Conclusion

In Re: National Prescription Opiate Litigation exemplifies how mass tort actions can enforce accountability in the pharmaceutical industry. By dissecting deceptive practices and distribution failures, it sets precedents that could reshape drug patent strategies and regulatory compliance for years to come.

Key Takeaways

• Substantial Settlements: Over $50 billion in agreements highlight the financial toll on defendants, emphasizing the need for robust risk management.
• Regulatory Reforms: The case drives changes in DEA quotas and FDA marketing oversight, impacting how patented drugs enter the market.
• Industry Shifts: Companies must integrate litigation lessons into patent strategies, focusing on ethical marketing to mitigate future risks.
• Public Health Focus: Funds from settlements prioritize addiction treatment, offering a model for addressing crises linked to pharmaceuticals.
• Long-Term Vigilance: Stakeholders should monitor ongoing appeals, as they could influence broader tort law and intellectual property standards.

FAQs

1. What triggered the In Re: National Prescription Opiate Litigation?
   This MDL arose from lawsuits by governments and entities blaming opioid manufacturers and distributors for the epidemic through misleading promotion and poor oversight.

2. How have settlements affected pharmaceutical companies?
   Settlements have imposed billions in payments and required operational changes, such as enhanced tracking, forcing companies to reassess patent and marketing strategies.

3. What role did patents play in the opioid crisis?
   Patents on formulations like OxyContin enabled exclusive marketing, which plaintiffs argued contributed to overpromotion and addiction, leading to legal challenges.

4. Are there ongoing trials in MDL 2804?
   While many cases have settled, some remain active, with appeals focusing on settlement terms and unresolved claims against certain defendants.

5. How can businesses use this case for decision-making?
   Executives should analyze the litigation to strengthen compliance programs, evaluate patent risks, and prepare for potential regulatory shifts in the pharma sector.

Sources

1. In Re: National Prescription Opiate Litigation, MDL No. 2804, U.S. District Court for the Northern District of Ohio (court filings and docket).