Find this week’s updates on 340B litigation 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: Contract Pharmacy; HRSA Audit Process; Other

• A drug manufacturer filed suit against the Health Resources and Services Administration (HRSA) to challenge HRSA’s determination that its proposed rebate model violates the 340B statute.
• In two HRSA audit process cases, HRSA filed a motion to dismiss for a lack of subject-matter jurisdiction and failure to state a claim.
• In a breach of contract claim filed by a 340B Covered Entity against several related party Medicare Advantage plans, defendants filed a notice of non-opposition, and the court granted plaintiff’s motion for leave to file a second amended complaint and motion to file the second amended complaint under seal.
• In an appealed qui tam action alleging that various drug manufacturers failed to charge accurate ceiling prices to 340B Covered Entities, the appellant filed a reply brief.
• In four consolidated Kansas contract pharmacy cases, the parties filed a joint stipulation of dismissal without prejudice.
• In eight cases challenging a proposed state law governing contract pharmacy arrangements in West Virginia, Missouri, and Mississippi:
  1. WV: In all three cases, defendants filed follow-up status reports. In one of the three cases, plaintiff filed a response to defendants’ prior status report. In another of the three cases, plaintiff filed a notice of supplemental authority.
  2. MS: Plaintiffs in two separate cases filed reply briefs in the Fifth Circuit Court of Appeals.
  3. MO: In one case, amici filed an amicus brief in support of defendants’ motion to dismiss and the court denied defendants’ motion to transfer the case. In a second case, intervenors filed suggestions in support of intervenors’ motion to dismiss. In a third case, intervenors filed reply suggestions in support of intervenors’ motion to dismiss.

Nadine Tejadilla and Matt David, law clerks in McDermott’s Los Angeles office, also contributed to this blog post.