Case: New England Donor Services, Inc. v. United States Department of Health and Human Services

1:25-cv-04329 | U.S. District Court for the District of District of Columbia

Filed Date: Dec. 12, 2025

Case Ongoing

Clearinghouse coding complete

Case Summary

(This summary is temporary, while we research the case.)

On December 12, 2025, plaintiffs - a coalition of nonprofit Organ Procurement Organizations - filed this lawsuit in U.S. District Court for the District of Columbia against the U.S. Department of Health and Human Services (HHS). Plaintiffs sought to challenge HHS and CMS' new requirements for OPO recertification and designation (the Outcome Rule) asserting that these requirements stand to upend the nation's organ donation system. Filing under the APA, Plaintiffs sought declaratory and injunctive relief barring Defendants from enforcing the provisions of the Outcome Rule.

This case is ongoing.

Summary Authors

Zoe Hayes (3/31/2026)

People

For PACER's information on parties and their attorneys, see: https://www.courtlistener.com/docket/72031487/parties/new-england-donor-services-inc-v-united-states-department-of-health-and/


Attorney for Plaintiff

Sverdlov, Alexander V. (District of Columbia)

Attorney for Defendant

Brown, Allison Ilene (District of Columbia)

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Documents in the Clearinghouse

Document
1

1:25-cv-04329

Complaint for Declaratory and Injunctive Relief

New England Donor Services v. United States Department of Health and Human Services

Dec. 12, 2025

Dec. 12, 2025

Complaint
15

1:25-cv-04329

Plaintiff's Motion for Summary Judgment

March 20, 2026

March 20, 2026

Pleading / Motion / Brief

Docket

See docket on RECAP: https://www.courtlistener.com/docket/72031487/new-england-donor-services-inc-v-united-states-department-of-health-and/

Last updated April 20, 2026, 3:22 a.m.

ECF Number Description Date Link Date / Link
1

COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF against CENTERS FOR MEDICARE & MEDICAID SERVICES, ROBERT FRANCIS KENNEDY, JR, MEHMET OZ, MD, UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES ( Filing fee $ 405 receipt number ADCDC-12133540) filed by NEW ENGLAND DONOR SERVICES, INC., WE ARE SHARING HOPE SC, GIFT OF LIFE MICHIGAN. (Attachments: # 1 Attachment A, # 2 Attachment B, # 3 Attachment C, # 4 Civil Cover Sheet, # 5 Summons - U.S. Department of Health & Human Services, # 6 Summons - ROBERT FRANCIS KENNEDY, Jr.ROBERT FRANCIS KENNEDY, Jr., # 7 Summons - Centers for Medicare & Medicaid Services, # 8 Summons - MEHMET OZ, M.D.)(Sverdlov, Alexander) (Entered: 12/12/2025)

1 Attachment A

View on PACER

2 Attachment B

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3 Attachment C

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4 Civil Cover Sheet

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5 Summons - U.S. Department of Health & Human Services

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6 Summons - ROBERT FRANCIS KENNEDY, Jr.ROBERT FRANCIS KENNEDY, Jr.

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7 Summons - Centers for Medicare & Medicaid Services

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8 Summons - MEHMET OZ, M.D.

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Dec. 12, 2025

Dec. 12, 2025

Clearinghouse
2

ERRATA Correcting Complaint Caption by GIFT OF LIFE MICHIGAN, NEW ENGLAND DONOR SERVICES, INC., WE ARE SHARING HOPE SC re 1 Complaint,,. (Attachments: # 1 Complaint, # 2 Attachment A, # 3 Attachment B, # 4 Attachment C)(Sverdlov, Alexander) (Entered: 12/15/2025)

Dec. 15, 2025

Dec. 15, 2025

3

REQUEST FOR SUMMONS TO ISSUE Summons for the U.S. Attorney General, et al. filed by NEW ENGLAND DONOR SERVICES, INC., WE ARE SHARING HOPE SC, GIFT OF LIFE MICHIGAN. Related document: 1 Complaint,, filed by GIFT OF LIFE MICHIGAN, WE ARE SHARING HOPE SC, NEW ENGLAND DONOR SERVICES, INC.. (Attachments: # 1 Summons U.S. Attorney for D.C., # 2 Summons U.S. Department of Health and Human Services, # 3 Summons Robert Franic Kennedy, J.R., in his official capacity as Secretary of HHS, # 4 Summons Centers for Medicare and Medicaid Services, # 5 Summons Mehmet Oz, M.D. in his official capacity as Administrator of CMS)(Sverdlov, Alexander) (Entered: 12/15/2025)

Dec. 15, 2025

Dec. 15, 2025

Notice of Error- New Case

Dec. 15, 2025

Dec. 15, 2025

NOTICE OF NEW CASE ERROR regarding 1 Complaint,,. The following error(s) need correction: Noncompliance with LCvR 5.1(c). Please file a Notice of Errata stating the error and attach the corrected initiating pleading to include the name & full residence address of each party and file using the event Errata. Missing summonses- U.S. government. When naming a U.S. government agent or agency as a defendant, you must supply a summons for each defendant & two additional summonses for the U.S. Attorney & U.S. Attorney General. Please submit using the event Request for Summons to Issue. COMPLIANCE DEADLINE is by close of business today. This case will not proceed any further until all errors are satisfied. (znmw)

Dec. 15, 2025

Dec. 15, 2025

4

Electronic Summons Issued as to AUSA,USAG

Dec. 16, 2025

Dec. 16, 2025

Case Assigned/Reassigned

Dec. 16, 2025

Dec. 16, 2025

5

Appear Pro Hac Vice

Dec. 30, 2025

Dec. 30, 2025

MINUTE ORDER granting 5 Motion for Leave to Appear Pro Hac Vice. Counsel should register for e-filing via PACER and file a notice of appearance pursuant to LCvR 83.6(a) Click for instructions. Signed by Judge Sparkle L. Sooknanan on 1/6/2026. (lcal)

Jan. 6, 2026

Jan. 6, 2026

MINUTE ORDER granting 13 Joint Motion for Scheduling Order. The Defendants will provide the administrative record for the challenged rule to the Plaintiffs by February 20, 2026. The Plaintiffs will file their motion for summary judgment by March 20, 2026. The Defendants will file a cross-motion to dismiss and/or for summary judgment and response to the Plaintiffs' motion by April 24, 2026. The Plaintiffs will file a response to the Defendants' cross-motion and reply in support of their own motion by May 15, 2026. The Defendants will file a reply in support of their cross-motion by June 5, 2026. The Court VACATES the Defendants' deadline to respond to the Plaintiffs' Complaint under Federal Rule of Civil Procedure 12(a)(2). Signed by Judge Sparkle L. Sooknanan on 2/19/2026. (lcal)

Feb. 19, 2026

Feb. 19, 2026

15

MOTION for Summary Judgment by Donor Network of Arizona, GIFT OF LIFE MICHIGAN, NEW ENGLAND DONOR SERVICES, INC., WE ARE SHARING HOPE SC. (Attachments: # 1 Memorandum in Support, # 2 Text of Proposed Order)(Sverdlov, Alexander) (Entered: 03/20/2026)

March 20, 2026

March 20, 2026

Clearinghouse

Case Details

State / Territory:

District of Columbia

Case Type(s):

Healthcare Access and Reproductive Issues

Special Collection(s):

Trump Administration 2.0: Challenges to the Government

Key Dates

Filing Date: Dec. 12, 2025

Case Ongoing: Yes

Plaintiffs

Plaintiff Description:

A coalition of nonprofit Organ Procurement Organizations.

Plaintiff Type(s):

Private Plaintiff

Public Interest Lawyer: No

Filed Pro Se: No

Class Action Sought: No

Class Action Outcome: Not sought

Case Details

Causes of Action:

Administrative Procedure Act, 5 U.S.C. §§ 551 et seq.

Other Dockets:

District of District of Columbia 1:25-cv-04329

Available Documents:

Complaint (any)

Trial Court Docket

Outcome

Prevailing Party: None Yet / None

Relief Sought:

Declaratory judgment

Injunction

Relief Granted:

None yet

Source of Relief:

None yet

Content of Injunction:

Reinstatement (job, contract, grant, etc.)

Issues

Medical/Mental Health Care:

Medical care, general

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