Find updates on 340B litigation from December 17, 2024 – January 6, 2025 to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick summary of relevant updates from the prior week in this industry-shaping body of litigation. 

Issues at Stake: HRSA Audit Process, Contract Pharmacy; Other

• In a Health Resources and Services Administration (HRSA) audit process case, the government filed a brief in opposition to the plaintiff’s motion for preliminary injunction and the plaintiff filed a reply brief in support of the same motion.
• In four HRSA audit process cases, the plaintiffs filed responses to the defendants’ motions to dismiss and briefs in opposition to Johnson & Johnson Health Care System Inc.’s motions for leave to file as amicus curiae.
• In an appealed case challenging a proposed state law governing contract pharmacy arrangements, the appellants filed their opening brief.
• In a breach of contract claim filed by a 340B Covered Entity against several related party Medicare Advantage plans, plaintiffs filed a second amended complaint under seal with jury demand. Additionally, defendants filed an answer and defenses to plaintiffs’ second amended complaint
• In a case challenging HRSA’s policy prohibiting manufacturer rebate models, defendants filed a consent motion to vacate the answer deadline and set summary judgment briefing schedule.
• A covered entity filed a breach of contract claim against an insurance company, alleging that it failed to pay the covered entity the proper amounts because it relied on an outpatient prescription reimbursement rate ruled unlawful by the US Supreme Court.
• A group of drug manufacturers filed a claim against HRSA, alleging that HRSA’s decision to certify a group of entities as 340B-eligible was arbitrary, capricious, and not in accordance with law.
• In seven cases challenging a proposed state law governing contract pharmacy arrangements in West Virginia, Missouri, and Mississippi:
  • WV: In three cases, the court issued a memorandum opinion and order granting plaintiffs’ preliminary injunction motions, denying defendants’ motions to dismiss, and ordering defendants to file answers to plaintiffs’ complaints. In three of the cases, the court granted the parties’ joint motion for extension of time for plaintiff to respond to defendants’ motions to consolidate. In another one of the cases, plaintiffs filed a memorandum in opposition to defendants’ motion to consolidate and stay deadlines pending the court’s ruling on motions for preliminary injunction. In one of the cases, defendants filed an answer to plaintiff’s complaint.
  • MS: The court denied the plaintiff’s motion for preliminary injunction.
  • MO: The court denied defendant’s motion for transfer in two cases. In one case, plaintiff filed reply suggestions in support of the motion for preliminary injunction. In another case, plaintiff filed suggestions in opposition to a motion to dismiss for failure to state a claim.