Order-by-Order CSA Compliance and Monetary Abatement: Fourth Circuit Holds Opioid Distribution Can Constitute a Public Nuisance Under West Virginia Law
Case: City of Huntington, West Virginia & Cabell County Commission v. AmerisourceBergen Drug Corp., Cardinal Health, Inc., and McKesson Corp.
Court: United States Court of Appeals for the Fourth Circuit
Date: October 28, 2025
Disposition: Vacated and remanded with instructions (opinion by Senior Judge Keenan; Judges King and Benjamin concurring)
Introduction
This published Fourth Circuit decision reorients the legal framework for opioid public-nuisance litigation under West Virginia law. Two local government plaintiffs—the City of Huntington and Cabell County Commission—sued the three dominant national opioid distributors (AmerisourceBergen, Cardinal Health, and McKesson) alleging that the companies’ distribution practices helped create and perpetuate an opioid-driven public-health crisis in their communities.
After a 70-witness bench trial, the district court entered judgment for the distributors, holding (1) West Virginia common-law public nuisance does not encompass product-distribution cases like prescription opioids; (2) even if it did, plaintiffs failed to prove unreasonable interference, proximate cause, and a proper abatement remedy; and (3) abatement cannot include funding programs to remediate opioid harms. On appeal, the Fourth Circuit rejected those foundational rulings and remanded for renewed fact-finding under corrected legal standards.
Key issues decided:
- Whether West Virginia’s common law allows a public nuisance claim based on conditions caused by the distribution of a controlled substance (prescription opioids).
- How to correctly construe a distributor’s duties under the federal Controlled Substances Act (CSA)—in particular, whether duties include order-by-order suspicious order detection and reporting.
- How to analyze proximate cause and remoteness, including the role of “outlier” prescribers, pharmacies, and diversion as alleged intervening causes.
- Whether abatement under West Virginia law may include monetary funding for programs and services to eliminate the harmful conditions constituting the nuisance.
Summary of the Opinion
The Fourth Circuit holds and instructs as follows:
- Public nuisance scope (WV law): Conditions caused by the distribution of opioids can constitute a public nuisance. West Virginia’s broad, Restatement (Second)-aligned definition is not categorically limited to property-based interference or to non-product harms. The district court erred in holding otherwise.
- CSA duties (federal law integrated into nuisance analysis): Distributors’ duties include designing and operating systems to detect and report order-by-order suspicious orders (unusual size, pattern deviations, unusual frequency). The district court applied the wrong, narrower standard (limited to avoiding “adjuncts of the illicit market”), which materially affected its findings on unreasonableness, causation, and remoteness.
- Proximate cause and remoteness: The district court’s analysis is vacated. On remand, the court must reconsider causation in light of the correct CSA duties and the documentary evidence (including repeated threshold increases that could avoid DEA reporting and data indicating “outlier” prescribers). Foreseeable conduct by prescribers, pharmacists, or diversion cannot automatically be treated as an independent intervening cause cutting off liability.
- Abatement remedy (WV law): Abatement in equity is not limited to stopping wrongful conduct; it may encompass remediation of harmful conditions and can include monetary payments to fund the abatement. The district court erred in rejecting the plaintiffs’ plan as categorically improper “money damages.” On remand, the court should evaluate the plan’s components for reasonable relation to abatement and may strike or reduce items.
Analysis
Precedents and Authorities Cited
West Virginia common law on public nuisance:
- State ex rel. Smith v. Kermit Lumber & Pressure Treating Co., 488 S.E.2d 901 (W. Va. 1997): Defines public nuisance as an act or condition that unlawfully hurts or inconveniences an indefinite number of persons; emphasizes continuing harm until abated and suggests abatement can require expenditures by defendants.
- Duff v. Morgantown Energy Assocs., 421 S.E.2d 253 (W. Va. 1992): Aligns WV law with Restatement (Second) of Torts § 821B—public nuisance is an “unreasonable interference with a right common to the general public.” Provides a balancing framework where conduct is otherwise lawful.
- Sharon Steel Corp. v. City of Fairmont, 334 S.E.2d 616 (W. Va. 1985): Reaffirms the public/private nuisance distinction; public nuisance affects the general public.
- West v. National Mines Corp., 285 S.E.2d 670 (W. Va. 1981): Courts may require a party to remedy conditions giving rise to the nuisance, supporting abatement tailored to harmful conditions, not just conduct cessation.
- Sergent v. City of Charleston, 549 S.E.2d 311 (W. Va. 2001); McCoy v. Cohen, 140 S.E.2d 427 (W. Va. 1965); Yates v. Mancari, 168 S.E.2d 746 (W. Va. 1969): Proximate cause principles—conduct must contribute in an uninterrupted sequence; multiple proximate causes are possible.
- Boyce v. Monongahela Power Co., 894 S.E.2d 913 (W. Va. 2023); Wal-Mart Stores E., L.P. v. Ankrom, 854 S.E.2d 257 (W. Va. 2020); Marcus v. Staubs, 736 S.E.2d 360 (W. Va. 2012): Intervening cause doctrine—foreseeable intervening acts do not sever causation; an intervening act must be an independent, sole proximate cause to break the chain.
- Moats, 859 S.E.2d 374 (W. Va. 2021) (Mass Litigation Panel context): Acknowledges courts may craft equitable injunctions entailing payments; situates WV opioid litigation landscape.
Federal CSA regulatory regime and cases:
- CSA and regulations: 21 U.S.C. §§ 801–904; § 823(b) (public interest; effective controls against diversion); § 832 (suspicious order reporting, added by SUPPORT Act); 21 C.F.R. §§ 1301.71(a)-(b) (effective controls), 1301.74(b) (suspicious orders defined), 1308.12 (Schedule II); Gonzales v. Raich, 545 U.S. 1 (2005) (closed regulatory system).
- Masters Pharm., Inc. v. DEA, 861 F.3d 206 (D.C. Cir. 2017): Distributors must design/operate systems to detect and report suspicious orders and either block shipment or conduct due diligence before shipping to avoid diversion.
- DEA guidance: Southwood Pharm., Inc., 72 Fed. Reg. 36,487, 36,501 (DEA 2007) (no shipping of suspicious orders without due diligence); DEA 2023 commentary cataloging red flags and metrics.
Other jurisdictions and WV trial-level practice:
- Oklahoma: State ex rel. Hunter v. Johnson & Johnson, 499 P.3d 719 (Okla. 2021) (limiting public nuisance under statutes; distinguished—WV issue is common law, not limited by statute).
- Ohio: In re Nat’l Prescription Opiate Litig., 2024 WL 5049302 (Ohio Dec. 10, 2024) (statutory abrogation of certain public nuisance claims; inapplicable to WV).
- Maine: E. Maine Med. Ctr. v. Walgreens, 331 A.3d 380 (Me. 2025) (private hospitals lacked distinct injury; dictum favoring Restatement Third; not controlling and factually distinct).
- Other courts permitting opioid nuisance theories: e.g., City & Cnty. of San Francisco v. Purdue Pharma L.P., 620 F. Supp. 3d 936 (N.D. Cal. 2022); Alaska v. Express Scripts, Inc., 2024 WL 2321210 (D. Alaska 2024); King Cnty. v. Express Scripts, Inc., 2025 WL 1082130 (W.D. Wash. 2025).
- West Virginia circuit/MLP rulings: Morrisey v. AmerisourceBergen (Dec. 12, 2014) and Brooke Cnty. Comm’n v. Purdue Pharma (Dec. 28, 2018) (recognizing opioid-based public nuisance claims); MLP orders (2019–2022) similarly recognizing viability against distributors and pharmacies.
- WV Intermediate Court: A.D.A. v. Johnson & Johnson, 912 S.E.2d 37 (W. Va. Ct. App. 2024) (manufacturer not per se insulated by downstream prescriber/consumer acts—relevant to causation analysis).
Legal Reasoning
1) Public nuisance extends to conditions caused by opioid distribution
Predicting West Virginia law in the absence of a controlling decision, the court relies on the state’s consistent use of Restatement (Second) of Torts § 821B. West Virginia defines public nuisance broadly as an “unreasonable interference with a right common to the general public,” and as an “act or condition” harming an indefinite number of people. Nothing in WV law carves out a categorical bar for product-related harms, and the state high court—when declining the certified question—emphasized that “whether a nuisance exists is a factual issue.” The Fourth Circuit, therefore, rejects the district court’s Restatement (Third)-style limitation and holds that a product’s distribution can, on proper proof, unreasonably interfere with public rights and constitute a public nuisance in West Virginia.
2) CSA duties require order-by-order suspicious order monitoring and reporting
The district court’s narrow reading—limiting distributor obligations to avoiding sales to “illicit” or sham pharmacies—conflicted with the text and structure of the CSA and DEA regulations. The Fourth Circuit reinstates the order-level focus:
- Distributors must “design and operate a system” to identify and report “suspicious orders” (unusual size, substantial deviation from normal pattern, unusual frequency). 21 C.F.R. § 1301.74(b).
- Once an order is suspicious, a distributor must block shipment or conduct due diligence and only ship if it determines the order is unlikely to be diverted. Masters Pharm., 861 F.3d at 212–13.
- This ongoing, order-specific duty empowers DEA to aggregate reports across the closed system and detect diversion early—well before a pharmacy devolves into an “adjunct of the illicit market.”
Because the district court assessed “unreasonableness” under an erroneous legal standard, its finding that the distributors “substantially complied” cannot stand. On remand, the court must reassess unreasonableness using the correct CSA framework and the full record, including documentary evidence showing frequent threshold-limit increases and very low suspicious-order reporting relative to threshold exceedances.
3) Proximate cause and remoteness must be reconsidered
West Virginia recognizes multiple proximate causes; a defendant’s conduct that contributes in an uninterrupted sequence to harm can be a proximate cause even if other actors (physicians, pharmacists, consumers) also contributed. The district court’s causation analysis is vacated for three principal reasons:
- Wrong legal standard infecting causation: By understating CSA duties, the court did not squarely assess the causal significance of distributors’ practices—especially repeated threshold-limit increases that may have allowed suspicious orders to avoid DEA reporting and additional scrutiny.
- Evidence of “outlier” prescribers: The record shows the top 1% of prescribers accounted for roughly 40% of opioid dosages in Cabell County, and the distributors had access to dispensing data capable of identifying outliers. Emails warned of “troublesome drugs” and flagged specific prescribers. The court must consider how distributors’ order-monitoring systems accounted for pharmacy orders serving those outliers.
- Intervening cause doctrine misapplied: Acts of doctors, pharmacists, and diversion are not automatically “intervening causes” that break the chain. Under WV law, foreseeable intervening acts do not sever causation; to break the chain an intervening act must operate independently as the sole proximate cause. The court must analyze foreseeability and the interaction of all actors in the closed system.
4) Abatement may encompass remediation and monetary funding
The Fourth Circuit clarifies West Virginia abatement law:
- Abatement targets both wrongful conduct and the conditions that constitute the public nuisance. WV precedent contemplates abatement that endures until harmful conditions are remediated (e.g., hazardous waste removal), not merely until wrongful acts cease.
- Equitable abatement can require a defendant to expend funds to eliminate the nuisance. The court rejects the district court’s per se bar on “monetary abatement,” noting equity’s broad remedial powers and WV’s indications that abatement may entail expenditures by the defendant.
- On remand, the trial court should evaluate the plaintiffs’ 15-year, $2.5 billion plan item-by-item to determine whether each component is reasonably calculated to abate the nuisance. The court may strike components or equitably reduce costs where appropriate.
Impact
For West Virginia litigation:
- Eliminates the categorical defense that public nuisance cannot address harms from lawful product distribution. Public entities in WV can proceed on nuisance theories tied to opioid distribution upon evidentiary showings of unreasonable interference with public health.
- Sets a high bar for CSA compliance proof: Plaintiffs can probe whether distributors’ suspicious-order monitoring was designed and operated to catch order-level anomalies, not just to screen out illicit pharmacies. Documentary proof of threshold-limit inflation, low reporting, and use of available data on prescriber outliers will be central.
- Clarifies that “intervening” acts by physicians, pharmacists, or patients are not automatic shields; courts must assess foreseeability and whether such acts truly break causation.
- Authorizes courts to craft monetary abatement remedies funding treatment, prevention, recovery, and targeted services—a significant tool for municipalities combating entrenched public-health harms.
Beyond West Virginia:
- Although grounded in WV common law, the CSA duty analysis reinforces nationally applicable principles from Masters Pharm.: distributors must maintain order-by-order suspicious-order systems and act on red flags.
- Signals skepticism toward the Restatement (Third)’s product-based public nuisance limitation where a state has not adopted it. Other jurisdictions with Restatement (Second)-oriented nuisance law may find this reasoning persuasive.
- Normalizes equitable monetary abatement in public-health nuisance cases, consistent with other federal circuit decisions recognizing injunctions that compel expenditures to remediate hazards.
Complex Concepts Simplified
- Public nuisance (WV): A broad tort focused on harms to the community at large (like public health and safety), not just harms to discrete individuals. It requires “unreasonable interference” with public rights. It is often remedied through equitable abatement.
- Restatement (Second) vs. Restatement (Third): WV follows the Second’s definition (broad, not categorically product-barred). The Third suggests product-related harms should generally be addressed by product liability, but WV has not adopted that approach.
- CSA “closed system” and suspicious orders: Every manufacturer, distributor, and dispenser must be registered. Distributors must have systems to detect and report suspicious orders (unusual size, pattern deviation, unusual frequency). After reporting, they must either block shipment or conduct due diligence before shipping.
- Threshold limits: Distributors often set monthly quantity limits for each pharmacy. Raising thresholds can reduce the number of flagged orders. If raised routinely without rigorous review, it can blunt suspicious-order detection and DEA reporting—an issue central to plaintiffs’ theory.
- Proximate cause vs. intervening cause: Proximate cause links conduct to harm in an uninterrupted sequence; there can be multiple proximate causes. Intervening causes sever liability only if they are independent and the sole proximate cause. Foreseeable actions by others generally do not cut off causation.
- Abatement vs. damages: Abatement is equitable relief aimed at eliminating a public nuisance going forward. It can require defendants to pay for remediation programs and services. By contrast, damages compensate past injuries to a plaintiff.
- Balancing test (unreasonableness): When conduct is otherwise lawful, courts weigh its utility against the gravity and avoidability of harm. If conduct is unlawful (e.g., contravenes statutes or regulations), that can itself establish unreasonableness.
What the District Court Must Do on Remand
- Reassess “unreasonable interference” using the correct CSA duties (order-by-order suspicious-order detection/reporting), and weigh the full documentary record, including threshold increases and reporting practices.
- Reevaluate proximate cause and remoteness, expressly analyzing:
- Whether repeated threshold-limit increases and limited reporting foreseeably contributed to oversupply and diversion;
- How the distributors used available data to address pharmacy orders serving known or knowable “outlier” prescribers;
- Whether doctors/pharmacies/diverters were foreseeable participants in a chain of causation rather than independent, sole proximate causes.
- If liability is found, analyze the abatement plan component-by-component for reasonable fit to eliminating the nuisance, and exercise equitable discretion to approve, modify, or reduce costs.
Conclusion
This decision establishes three core propositions likely to reverberate through opioid litigation and beyond in West Virginia:
- No categorical bar: Public nuisance can reach conditions caused by the distribution of prescription opioids where the evidence shows unreasonable interference with public rights.
- CSA duties matter—at the order level: Distributors must design and operate systems that find and address suspicious orders. Courts must evaluate not only system design but also operation—including how threshold practices, due diligence, and DEA reporting functioned in practice.
- Abatement can fund remediation: Equitable abatement may require defendants to pay for programs and services that eliminate the nuisance’s harmful conditions. Courts should tailor relief to what is reasonably needed to abate the public-health crisis.
By vacating and remanding, the Fourth Circuit directs the trial court to reconsider unreasonableness, causation, and remedy under corrected legal standards and the robust evidentiary record. The opinion supplies a roadmap for future cases: align nuisance analysis with Restatement (Second) principles, ground “unreasonable interference” in statutory/regulatory duties where applicable, reject overbroad intervening-cause defenses where downstream conduct is foreseeable, and embrace equitable abatement capable of addressing entrenched public-health harms.
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