130 F.4th 91
4th Cir.2025Background
- Plaintiffs are entities that claim to have been assigned recovery rights by health insurers (“Assignors”) who reimbursed for Xenazine, a specialty drug manufactured by Lundbeck.
- Plaintiffs allege Lundbeck, a specialty pharmacy (TheraCom), and two nonprofit Patient Assistance Programs (CVC and Adira Foundation) colluded to inflate Xenazine prices and quantities, violating RICO and state laws.
- The Department of Justice previously settled similar allegations against Lundbeck without admission of fault, centered on Anti-Kickback Statute violations.
- The district court dismissed the complaint with prejudice, finding a failure to plead that defendants’ conduct proximately caused the claimed injuries.
- Plaintiffs appealed, challenging dismissals under RICO, state consumer protection, unjust enrichment, and the denial of leave to amend.
- On appeal, the Fourth Circuit affirmed most of the district court’s decision but reversed in part on standing for unidentified assignors and remanded those claims for dismissal without prejudice.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Article III standing for all assignors | Plaintiffs as assignees have standing for both named and unnamed assignors | Standing only exists for specifically identified assignors; not for unidentified ones | Standing affirmed for five named assignors, denied for unidentified ones |
| RICO Claims – Proximate Causation | Defendants’ conduct directly caused assignors’ injuries by inflating Xenazine costs | Injuries are too indirect/attenuated, interrupted by other actors and purchasing chains | Proximate cause not adequately pleaded; claims dismissed |
| State Law Claims (Consumer Protection & Unjust Enrichment) | Assignors suffered actionable injuries under various state laws due to inflated reimbursements | Plaintiffs failed to plead with the required factual specificity and causation | Dismissed for failure to state a claim |
| Leave to Amend & Injunctive Relief | Denial was error, could cure deficiencies with amendment and merits injunctive relief | Amendment futile as fundamental causation issues persist; no merit to injunction | No abuse of discretion; denial affirmed |
Key Cases Cited
- Holmes v. Sec. Investor Prot. Corp., 503 U.S. 258 (RICO proximate causation turns on the directness of the relationship between injury and conduct)
- Anza v. Ideal Steel Supply Corp., 547 U.S. 451 (No RICO proximate causation where the alleged predicate act is too distinct from the alleged injury)
- Hemi Group, LLC v. City of New York, 559 U.S. 1 (Directness, not foreseeability, is required for RICO proximate cause)
- Sedima, S.P.R.L. v. Imrex Co., 473 U.S. 479 (Sets out elements of a civil RICO action)
- Ashcroft v. Iqbal, 556 U.S. 662 (Pleading standard under Rule 8; conclusory allegations insufficient)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (Pleading standard; requires factual allegations sufficient to state a claim)
