HEALTH & LIFE SCIENCES NEWS
HEALTH & LIFE SCIENCES NEWS
Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries
HEALTH & LIFE SCIENCES NEWS
Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries

This Week in 340B: December 10 – 16, 2024

Posted In 340B

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. Get more details on these 340B cases and all other material 340B cases pending in federal and state courts with the 340B Litigation Tracker.

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. 

Emily Jane Cook
Emily Cook is a practice area leader for McDermott's Healthcare Regulatory & Compliance practice. She is a national authority on the 340B drug pricing program, and also helps clients navigate the full suite of federal and state regulations that are essential to healthcare operations. Learn more about Emily's practice here.


Reuben Bank
Reuben Bank provides regulatory and transactional counseling on all aspects of state and federal healthcare laws impacting hospitals and healthcare systems. Click here to learn more about Reuben's practice: https://www.mwe.com/people/reuben-bank/


Margaret Houtz
Margaret (Maggie) Houtz is a member of the Healthcare Practice Group, where she works on a range of transactional and regulatory matters affecting the healthcare industry.Learn more about Maggie's practice here.


Patrick Moore
Patrick Moore is an associate in McDermott's Healthcare Practice Group. While earning his law degree, Patrick served as a legal intern for a global life sciences research organization and as managing editor of the Journal of International Law and Foreign Affairs at UCLA School of Law.Learn more about Patrick's practice here.


Deepika Raj
Deepika Raj advises a broad range of healthcare industry clients on regulatory, compliance and transactional matters. She offers multifaceted advice on state and federal fraud and abuse statutes, licensure rules, cannabis laws and due diligence matters. Learn more about Deepika's practice here.


Kelsey Reinhardt
Kelsey R. Reinhardt focuses her practice on regulatory and transactional matters affecting a wide range of clients across the healthcare industry. Learn more about Kelsey's practice here.

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