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 3 – 9, 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: HRSA Audit Process; Contract Pharmacy; Other

  • In a Freedom of Information Act (FOIA) case, the Health Resources and Services Administration (HRSA) filed a reply in support of its cross-motion for partial summary judgment.
  • In a breach of contract claim filed by a 340B Covered Entity against several related party Medicare Advantage plans, the 340B Covered Entity filed a motion for leave to file its second amended complaint and the court ordered that the related party Medicare Advantage plans show cause why the motion for leave should not be granted.
  • In one HRSA audit process case, the plaintiff filed a motion for stay of agency action and preliminary injunction.
  • 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 case challenging HRSA’s policy prohibiting all manufacturer conditions on 340B transactions, the court approved the parties’ motion for leave to file an amended complaint.
  • In four cases challenging a proposed state law governing contract pharmacy arrangements in West Virginia and Missouri:
    • WV: In three cases, defendants filed status reports.
    • MO: Intervenors and defendants separately filed motions to dismiss following the plaintiff’s amended complaint.

Matt David, law clerk 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/


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.

STAY CONNECTED

TOPICS

ARCHIVES

Chambers 2021 Top Ranked
U.S. News Law Firm of the Year 2022 Health Care Law
LEgal 500 EMEA top tier firm 2021
Legal 500 USA top tier firm