Intervening 340B-Preemption Precedent Requires Vacatur and Remand of Preliminary-Injunction Rulings

I. Introduction

AbbVie, Inc. v. Anthony Brown (4th Cir. Apr. 14, 2026) is an unpublished Fourth Circuit decision arising from a multi-plaintiff challenge by drug manufacturers and an industry trade association to Maryland’s 2024 340B-related statute, H.B. 1056, codified at Md. Code § 12-6C-09.1.

The law targets only manufacturers participating in the federal 340B program (as defined by reference to 42 U.S.C. § 256b) and, in broad terms, prohibits a “340B manufacturer” from “directly or indirectly” limiting distribution of a “340B drug” to a contract pharmacy used by a covered entity, unless federal law or regulation requires the limitation.

The core issue at the preliminary-injunction stage was federal preemption: whether § 256b likely preempts Maryland’s attempt to regulate manufacturer distribution policies affecting 340B contract pharmacy arrangements.

II. Summary of the Opinion

The district court denied a preliminary injunction, concluding plaintiffs were unlikely to succeed on the merits. On appeal, the Fourth Circuit vacated and remanded, not because it conducted a fresh full merits analysis of Maryland’s statute in the first instance, but because an intervening Fourth Circuit decision—Pharm. Rsch. & Mfrs. of Am. v. McCuskey, No. 25-1054 (“PhRMA”)—held that a materially similar West Virginia statute was likely preempted and that the other preliminary-injunction factors supported relief.

Applying the principle that appellate courts apply intervening law to pending cases, the panel held the district court’s denial rested on an incorrect legal premise post-PhRMA. The Fourth Circuit therefore directed the district court to reconsider preliminary relief consistent with PhRMA.

III. Analysis

A. Precedents Cited

1. Pharm. Rsch. & Mfrs. of Am. v. McCuskey, No. 25-1054 (“PhRMA”)

PhRMA is the controlling driver of the disposition. The panel emphasized two holdings from PhRMA:

  • A materially similar “anti-limitation” state statute aimed at 340B contract pharmacy access was likely preempted. (The Maryland panel did not restate the entire preemption analysis, instead incorporating it by reference.)
  • The remaining preliminary-injunction factors favored relief. The panel cited PhRMA’s application of Winter v. Nat. Res. Def. Council, Inc., 555 U.S. 7, 20 (2008).

Functionally, AbbVie, Inc. v. Anthony Brown operates as an “application/remand” opinion: it does not announce a separate new test, but it cements PhRMA as the governing analytical framework for substantially similar Fourth Circuit 340B preemption challenges at the preliminary-injunction stage.

2. Winter v. Nat. Res. Def. Council, Inc., 555 U.S. 7 (2008)

Winter supplies the four-factor preliminary-injunction standard (likelihood of success, irreparable harm, balance of equities, public interest). The panel relied on PhRMA’s conclusion that these factors supported relief once preemption likelihood was established.

3. United States v. Schooner Peggy, 5 U.S. (1 Cranch) 103 (1801) and Thorpe v. Housing Auth. of Durham, 393 U.S. 268 (1969)

These cases provide the classic rule that courts apply intervening law to cases pending on appeal. The Fourth Circuit invoked them to justify vacating the district court’s order: even if the district court’s decision was reasonable when entered, PhRMA changed the controlling legal landscape.

4. Astra USA, Inc. v. Santa Clara Cnty., 563 U.S. 110 (2011)

The panel used Astra USA, Inc. v. Santa Clara Cnty. to characterize the 340B program as a “spending-power bargain” in which manufacturers “opt into” 340B discount obligations in exchange for access to Medicaid payment for covered drugs (as described in the opinion’s footnote). That framing is important because it underlies the broader debate—highlighted by the dissent—about whether and how the Spending Clause structure should affect preemption analysis.

5. Authorities emphasized in the dissent

Judge Benjamin’s dissent situates the majority’s approach against what she describes as the prevailing judicial trend rejecting preemption challenges to similar state statutes. The dissent cites:

  • AbbVie, Inc. v. Murrill, 166 F.4th 528 (5th Cir. 2026)
  • AbbVie, Inc. v. Fitch, 152 F.4th 635 (5th Cir. 2025)
  • Pharm. Rsch. & Mfrs. of Am. v. McClain, 95 F.4th 1136 (8th Cir. 2024)

The dissent also catalogs numerous district court decisions largely denying preliminary injunctions or rejecting preemption claims. While not controlling, this survey is deployed to argue the Fourth Circuit majority’s PhRMA approach is an outlier and, in her view, wrongly “heighten[s]” preemption analysis for Spending Clause legislation.

B. Legal Reasoning

1. The majority’s reasoning: procedural control by intervening precedent

The majority’s logic is intentionally narrow and operates in three steps:

  1. Similarity of statutes: Maryland’s H.B. 1056 is described as targeting 340B manufacturers and prohibiting limitations on distribution to covered entities’ contract pharmacies—conceptually the same regulatory move the court addressed in West Virginia’s law.
  2. Intervening decision: After the district court’s order, the Fourth Circuit decided PhRMA, holding the West Virginia statute likely preempted and finding the injunction factors favored relief.
  3. Mandatory application of new controlling law: Under United States v. Schooner Peggy and Thorpe v. Housing Auth. of Durham, the appellate court must apply intervening controlling law, rendering the district court’s earlier legal assessment erroneous as a matter of law.

Notably, the panel did not itself grant or deny the preliminary injunction. Instead, it remanded for the district court to apply PhRMA “in the first instance” to the Maryland record and posture.

2. The dissent’s reasoning: state power to protect 340B access and skepticism of “heightened” preemption

Judge Benjamin’s dissent frames 340B as a congressional effort to expand access for “vulnerable communities,” emphasizing that contract pharmacies are operationally essential for many covered entities. In her view:

  • States acted to prevent manufacturer policies that, she suggests, undermine 340B’s access goals.
  • The majority’s approach in PhRMA improperly introduces a heightened preemption analysis because 340B arises under the Spending Clause.
  • The weight of appellate and district authority, as she presents it, supports the conclusion that statutes like Maryland’s are not preempted.

Because the majority’s disposition in this case is explicitly tethered to PhRMA, the dissent’s disagreement is equally tethered: she would affirm the denial of preliminary injunctive relief for the same reasons she dissented in PhRMA.

C. Impact

1. Practical litigation impact in the Fourth Circuit

Even as an unpublished opinion, AbbVie, Inc. v. Anthony Brown signals that within the Fourth Circuit, district courts must treat PhRMA as the decisive template when evaluating preliminary injunction motions against 340B “contract pharmacy protection” statutes similar to West Virginia’s and Maryland’s.

The immediate impact is procedural but significant: district court denials based on pre-PhRMA reasoning are vulnerable to vacatur, and states defending comparable laws should expect renewed preliminary-injunction proceedings framed by PhRMA.

2. Substantive policy impact: state 340B enforcement uncertainty

By reinforcing that materially similar state laws are at least likely preempted under PhRMA, the decision contributes to uncertainty for:

  • States seeking to preserve contract pharmacy access through manufacturer-distribution mandates;
  • Manufacturers defending distribution limitations as consistent with federal 340B requirements and enforcement structure;
  • Covered entities and contract pharmacies whose operational models may depend on state protections.

3. Broader doctrinal impact: circuit tension and the Spending Clause framing

The dissent highlights a developing tension: multiple circuits (cited by the dissent) have rejected similar preemption challenges, while the Fourth Circuit (via PhRMA) has gone the other direction. That divergence increases the likelihood of continued appellate litigation and potentially eventual Supreme Court attention, particularly because the underlying program is a federal-state-adjacent scheme tied to Medicaid reimbursement.

IV. Complex Concepts Simplified

  • 340B program (42 U.S.C. § 256b): A federal program requiring participating drug manufacturers to sell certain drugs at discounted prices to qualifying “covered entities” serving low-income or vulnerable populations. Manufacturers participate to retain eligibility for certain federal payment streams (as described in the opinion’s footnote).
  • Contract pharmacy: A pharmacy that dispenses drugs on behalf of a covered entity that may not operate its own in-house pharmacy.
  • Federal preemption: Under the Supremacy Clause, state laws can be invalid if they conflict with federal law or intrude upon a field Congress intended the federal government to occupy. Here, the dispute is whether state “anti-limitation” rules conflict with § 256b’s structure and enforcement.
  • Preliminary injunction: An early, temporary court order blocking enforcement of a law while the case proceeds. Under Winter v. Nat. Res. Def. Council, Inc., the movant must satisfy multiple factors, including likelihood of success on the merits and irreparable harm.
  • Intervening precedent: When an appellate court issues a new controlling decision while a case is on appeal, courts apply that new law to the pending case (as reflected in United States v. Schooner Peggy and Thorpe v. Housing Auth. of Durham).
  • “Spending-power bargain”: A shorthand for federal programs where participation is voluntary but conditioned on accepting federal terms. The dissent argues that framing should not trigger a “heightened” preemption approach; the majority relies on PhRMA as controlling without re-litigating that debate here.

V. Conclusion

AbbVie, Inc. v. Anthony Brown establishes a clear operational rule for Fourth Circuit district courts addressing 340B contract-pharmacy restriction statutes at the preliminary-injunction stage: apply PhRMA, and if a district court decision predates PhRMA, it may require vacatur and remand under the intervening-precedent doctrine of United States v. Schooner Peggy and Thorpe v. Housing Auth. of Durham.

The majority’s opinion is brief but consequential: it imports PhRMA’s preemption trajectory into Maryland’s litigation and signals that similar statutes in the circuit will be evaluated through the same lens. The dissent underscores that this approach is contested nationally and may deepen an emerging split over the intersection of 340B, state health regulation, and federal preemption.