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: February 4 – 10, 2025

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; Rebate Model; Other

  • In a case brought by a 340B covered entity against the Health Resources and Services Administration (HRSA) alleging that HRSA prevented the covered entity from accessing the 340B Program, the covered entity filed a notice of voluntary dismissal.
  • In a case challenging HRSA’s policy prohibiting all manufacturer conditions on 340B transactions, plaintiffs filed a motion for summary judgment.
  • In a Freedom of Information Act (FOIA) case, the plaintiff filed a motion to strike HRSA’s motion for summary judgment.
  • In one HRSA audit process case, the plaintiff filed a brief in opposition to a drug manufacturer’s motion for leave to file as amicus curiae.
  • In four HRSA audit process cases, the parties filed joint stipulations that the government will provide to the plaintiffs thirty days’ written notice before termination of the plaintiffs from the 340B Program.
  • In five cases against HRSA alleging that HRSA unlawfully refused to approve drug manufacturers’ proposed rebate models:
    • In two cases, each drug manufacturer plaintiff filed a motion for summary judgment and a group of interested parties filed a motion to intervene.
    • In one case, two patient advocacy groups filed a motion for leave to file as amicus curiae.
    • In one case, the drug manufacturer plaintiff filed a motion for summary judgment, a group of interested parties filed a motion to intervene, and two patient advocacy groups filed a motion for leave to file as amicus curiae.
    • In one case, a group of interested parties filed a motion to intervene.
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.Learn more about Reuben's practice here.


Matthew David
Matthew David focuses his practice on transactional and regulatory matters affecting a wide range of clients in the healthcare industry.Learn more about Matthew's practice here.


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.


Jae Hyun Lee
Jae Hyun Lee is a member of the Healthcare Practice Group. He focuses his practice on healthcare mergers and acquisitions as well as regulatory and compliance matters. Read more about Jae'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.


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.


Nadine Tejadilla
Nadine Tejadilla focuses her practice on transactional and regulatory matters in the health and life sciences industry. While in law school, Nadine served as a legal intern at a national nonprofit civil rights organization.Learn more about Nadine's practice here.

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