HEALTH & LIFE SCIENCES NEWS

This Week in 340B: February 25 – March 3, 2025

by Emily Jane Cook, Reuben Bank, Matthew David, Margaret Houtz, Jae Hyun Lee, Deepika Raj, Kelsey Reinhardt and Nadine Tejadilla | Mar 5, 2025 | 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: Antitrust; Contract Pharmacy; HRSA Audit Process; Rebate Model

In an antitrust class action case, the court granted the defendant’s motion to dismiss.
In an appealed case challenging a proposed state law governing contract pharmacy arrangements, a group of amici filed an amicus brief in support of appellees.
In an appealed case challenging a proposed state law governing contract pharmacy arrangements, defendants-appellants filed an opening brief.
In a Freedom of Information Act (FOIA) case, the plaintiff filed a reply in support of its motion to strike the government’s motion for summary judgment.
In one one Health Resources and Services Administration (HRSA) audit process case, the plaintiff filed a supplemental brief in support of the plaintiff’s motion for preliminary injunction.
A group of 340B covered entities filed a complaint against a group of commercial payors, alleging that the payors were in breach of their contracts by failing to pay the proper amounts for 340B-acquired drugs.
In three cases challenging a proposed state law governing contract [...]

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Five Questions With a Health Lawyer: Stacey L. Callaghan

by McDermott Will & Emery | Feb 28, 2025 | Uncategorized

Stacey L. Callaghan
Practice Focus Area: Health and Life Sciences, Innovative Care Delivery
Office: Chicago
Years at Firm: 5

What is your favorite part about practicing healthcare law at McDermott?
My favorite part about practicing healthcare law here at McDermott is the phenomenal team. There are thought leaders in every sub-specialty you can imagine, and the people I work with everyday are genuinely kind, good people. I have worked at other firms with a shorter bench; the ease with which we are able to navigate incredibly complex issues here is special. I also love that the firm and practice group encourage us to develop areas about which we are passionate. Because of this, I’ve been fortunate to become the co-chair of our Women’s Digital Health Initiative.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today?
The biggest opportunity and the greatest challenge are both the fact that healthcare law is changing so rapidly, especially in the innovative care delivery space following the COVID-19 pandemic. There is more opportunity than ever before for healthcare companies and other stakeholders to be creative with their partnerships and their use of technology, but healthcare laws and regulations are still catching up to the innovation in many cases.

What advice would you give to junior lawyers looking to build their practice in your focus area?
I would [...]

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This Week in 340B: February 18 – 24, 2025

by Emily Jane Cook, Reuben Bank, Matthew David, Margaret Houtz, Jae Hyun Lee, Kelsey Reinhardt and Nadine Tejadilla | Feb 27, 2025 | 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; Rebate Model; Other

In one Health Resources and Services Administration (HRSA) audit process case, the government filed a memorandum in support of the government’s motion to dismiss.
In a case by a drug manufacture challenging a state law, the government filed a motion for judgment on the pleadings and the parties filed a joint motion for an amended protective order.
In a Freedom of Information Act (FOIA) case, the government filed a response to a motion to strike the government’s motion for summary judgment.
In a suit by a 340B covered entity against HRSA, the covered entity filed a notice of voluntary dismissal without prejudice.
In an appealed case challenging a proposed state law governing contract pharmacy arrangements, the appellees filed their opening brief.
A 340B covered entity filed a complaint against HRSA to challenge HRSA’s decision to allow a manufacturer’s audit.
In five cases against HRSA alleging that HRSA unlawfully refused to approve drug manufacturers’ [...]

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This Week in 340B: February 11 – 17, 2025

by Emily Jane Cook, Matthew David, Margaret Houtz, Jae Hyun Lee, Patrick Moore, Deepika Raj, Kelsey Reinhardt and Nadine Tejadilla | Feb 19, 2025 | 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; Medicare Payment; Rebate Model

In a case challenging a proposed state law governing contract pharmacy arrangements in Missouri, the court granted in part and denied in part defendant’s and intervenor’s separate motions to dismiss.
In a breach of contract claim filed by a 340B covered entity against several related party Medicare Advantage plans, defendants filed a reply in support of their motion to compel plaintiff’s claims spreadsheets.
In five cases against the Health Resources and Services Administration (HRSA) alleging that HRSA unlawfully refused to approve drug manufacturers’ proposed rebate models:
1. Five amicus briefs were filed in support of the drug manufacturer.
2. In four such cases, drug manufacturers filed a joint position statement on consolidation.
3. In one such case, a drug manufacturer filed a notice of opposition to consolidation and memorandum in opposition to intervenors.
4. In one such case, the government filed a position statement in support of consolidation.

This Week in 340B: February 4 – 10, 2025

by Emily Jane Cook, Reuben Bank, Matthew David, Margaret Houtz, Jae Hyun Lee, Patrick Moore, Kelsey Reinhardt and Nadine Tejadilla | Feb 12, 2025 | 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 [...]
  
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