MSP Recovery Claims, Series LLC v. Lundbeck LLC

130 F. 4th 91
CourtCourt of Appeals for the Fourth Circuit
DecidedFebruary 26, 2025
Docket24-1043
StatusPublished
Cited by12 cases

This text of 130 F. 4th 91 (MSP Recovery Claims, Series LLC v. Lundbeck LLC) is published on Counsel Stack Legal Research, covering Court of Appeals for the Fourth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
MSP Recovery Claims, Series LLC v. Lundbeck LLC, 130 F. 4th 91 (4th Cir. 2025).

Opinion

USCA4 Appeal: 24-1043 Doc: 55 Filed: 02/26/2025 Pg: 1 of 32

PUBLISHED

UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT

No. 24-1043

MSP RECOVERY CLAIMS, SERIES LLC, a Delaware series limited liability company; MSPA CLAIMS 1, LLC, a Florida limited liability company; MSP RECOVERY CLAIMS SERIES 44, LLC, a Delaware series limited liability company; MSP RECOVERY CLAIMS PROV, SERIES LLC, a Delaware series limited liability company; MSP RECOVERY CLAIMS CAID, SERIES LLC, a Delaware series limited liability company, on behalf of themselves and all others similarly situated,

Plaintiffs - Appellants,

v.

LUNDBECK LLC, a Delaware corporation; CARING VOICE COALITION, INC., an Idaho non-profit corporation; THERACOM, LLC, an Ohio corporation; ADIRA FOUNDATION, f/k/a Facilitating Patient Health, a Virginia non-profit corporation,

Defendants - Appellees.

Appeal from the United States District Court for the Eastern District of Virginia, at Richmond. Henry E. Hudson, Senior District Judge. (3:22−cv−00422−HEH)

Argued: October 29, 2024 Decided: February 26, 2025

Before DIAZ, Chief Judge, and WYNN and THACKER, Circuit Judges.

Affirmed in part, reversed in part, and remanded by published opinion. Judge Wynn wrote the opinion, in which Chief Judge Diaz and Judge Thacker joined. USCA4 Appeal: 24-1043 Doc: 55 Filed: 02/26/2025 Pg: 2 of 32

ARGUED: Samuel Robert Simkins, AKEEL & VALENTINE, PLC, Troy, Michigan, for Appellants. Kolya David Glick, ARNOLD & PORTER KAYE SCHOLER LLP, Washington, D.C.; Raymond A. Cardozo, REED SMITH LLP, San Francisco, California, for Appellee. ON BRIEF: Shereef H. Akeel, Adam S. Akeel, Daniel W. Cermak, Hayden Pendergrass, AKEEL & VALENTINE, PLC, Troy, Michigan; John W. Cleary, MSP RECOVERY LAW FIRM, Coral Gables, Florida; David Hilton Wise, William N. Evans, WISE LAW FIRM, PLC, Fairfax, Virginia, for Appellants. Thomas H. Suddath, Jr., Philadelphia, Pennsylvania, Douglas E. Pittman, REED SMITH LLP, Richmond, Virginia; Joshua M. Davis, Washington, D.C., Suneeta Hazra, Brian Williams, Denver, Colorado, Nicole L. Masiello, Laurel M. Ruza, Aidan Mulry, ARNOLD & PORTER KAYE SCHOLER LLP, New York, New York, for Appellees.

2 USCA4 Appeal: 24-1043 Doc: 55 Filed: 02/26/2025 Pg: 3 of 32

WYNN, Circuit Judge:

Plaintiffs are business entities that allegedly own recovery rights assigned to them

by health insurers and other third-party Medicare payors (“Assignors”). Assignors

reimbursed their enrollees for prescriptions of the specialty drug Xenazine. Plaintiffs allege

that Defendants—the manufacturer of Xenazine (Lundbeck LLC), a specialty pharmacy

(TheraCom, LLC), and two healthcare nonprofits (Caring Voice Coalition (“CVC”) and

Adira Foundation) 1—colluded to artificially inflate the price and dispensed quantity of

Xenazine in violation of the Racketeer Influenced and Corrupt Organizations Act

(“RICO”) and various state laws. As a result, Assignors were allegedly forced to reimburse

an inflated volume of Xenazine prescriptions at supra-competitive prices.

The district court dismissed the putative class-action complaint with prejudice,

holding that Plaintiffs did not and could not adequately allege that Defendants’ conduct

proximately caused Plaintiffs’ injuries. We affirm, except as noted below.

I.

A.

The Medicare program offers government-administered healthcare (Medicare Parts

A and B). In addition, it contracts with private health insurers to act as healthcare plan

sponsors for Medicare-eligible beneficiaries (Medicare Parts C and D). Private plan

sponsors may offer full-service health plans under the “Medicare Advantage” program

1 CVC dissolved shortly before this action began and has not appeared. Adira was an alleged replica and successor of CVC; it appeared below, but has since dissolved. Lundbeck and TheraCom are the only defendants appearing in this appeal.

3 USCA4 Appeal: 24-1043 Doc: 55 Filed: 02/26/2025 Pg: 4 of 32

(Part C), or prescription drug coverage (Part D).

Plans under Medicare Parts C and D typically require their beneficiaries to share the

cost of prescription drugs through deductibles, co-insurance, and/or co-payments. When a

pharmacy receives a prescription and dispenses a drug, the patient pays the co-payment or

co-insurance and the patient’s plan sponsor reimburses the pharmacy for the balance of the

drug’s cost. The plan sponsor is partially reimbursed by the Medicare program, either by

collecting a predetermined per-insured rate (under Part C) or through advance monthly

payments based on the plan sponsor’s per-member, per-month bid (under Part D).

In other words, the “purchase” of a prescription drug is “normally split three ways:

the physician effectively makes the decision to buy the product; the health insurer

effectively pays for it (although the patient is required to make a [co-payment]); and the

patient owns and uses it.” Humana, Inc. v. Biogen, Inc., 666 F. Supp. 3d 135, 152 (D. Mass.

2023). Although the patient is the end user, “third-party payors” (private plan sponsors)

are “the entities that actually pay for the drugs at issue,” beyond the patient’s cost-sharing

obligation. Id. at 153.

Medicare’s cost-sharing obligation functions as “a market safeguard against inflated

prices.” OIG Special Advisory Bulletin on Patient Assistance Programs for Medicare Part

D Enrollees, 70 Fed. Reg. 70623, 70626 (Nov. 22, 2005) (“2005 OIG Guidance”).

Nevertheless, co-payments for specialty prescription drugs, particularly in the period

before generic competitors emerge, are often prohibitively expensive for Medicare

patients. Drug manufacturers seek to alleviate patients’ out-of-pocket expenses—and

preserve demand for their products—by donating money to nonprofits called Patient

4 USCA4 Appeal: 24-1043 Doc: 55 Filed: 02/26/2025 Pg: 5 of 32

Assistance Programs (“PAPs”), which offer co-payment assistance to qualifying patients.

The federal government considers PAPs an “important safety net [for] patients of

limited means,” but also warns of “the potential for fraud and abuse” if PAPs are not

sufficiently independent from their pharmaceutical-industry donors. 2005 OIG Guidance

at 70624. To protect the price-regulating function of co-payments, the federal Anti-

Kickback Statute prohibits drug manufacturers from paying or otherwise compensating

Medicare patients for purchasing their drugs. 2 See 42 U.S.C. § 1320a-7b(b).

In that regard, the Department of Health and Human Services Office of the

Inspector General issued guidance in 2005 on how PAPs can serve Medicare patients

without violating the Anti-Kickback Statute. See 2005 OIG Guidance at 70623–27. The

guidance advised that no “pharmaceutical manufacturer” or “affiliate of the manufacturer”

“exert[] any direct or indirect influence or control over [a PAP]”; that PAPs “award[]

assistance in a truly independent manner and “without regard to the pharmaceutical

manufacturer’s interests”; and that a drug manufacturer “not solicit or receive data from [a

PAP] that would facilitate the manufacturer in correlating the amount or frequency of its

donations with the number of subsidized prescriptions for its products.” Id. at 70626.

In 2014, amid increased public scrutiny of PAPs’ potential influence on drug prices,

the Office of the Inspector General issued updated guidance emphasizing the “risk of fraud,

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