Case: Whole Woman's Health Alliance v. United States Food and Drug Administration

3:23-cv-00019 | U.S. District Court for the Western District of Virginia

Filed Date: May 8, 2023

Case Ongoing

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Case Summary

This is a case about federal restrictions on mifepristone, the first drug in the two-drug medication-abortion regimen, and whether the FDA can keep treating that medication as unusually dangerous despite repeatedly recognizing its safety. On May 8, 2023, a group of independent abortion providers and clinics in Virginia, Montana, and Kansas filed this lawsuit in the United States District Court for the Western District of Virginia, Charlottesville Division. The plaintiffs sued the United States…

On May 8, 2023, a group of independent abortion providers and clinics in Virginia, Montana, and Kansas filed this lawsuit in the United States District Court for the Western District of Virginia, Charlottesville Division. The plaintiffs sued the United States Food and Drug Administration (“FDA”); the Commissioner of Food and Drugs; the United States Department of Health and Human Services (“HHS”); and the Secretary of HHS. The plaintiffs were represented by the Center for Reproductive Rights. The case was later transferred on May 16, 2023, from Senior United States District Judge Norman K. Moon to United States District Judge Robert S. Ballou.

The complaint alleged that mifepristone had been safely used for more than two decades and by millions of patients, but that the FDA continued to impose a Risk Evaluation and Mitigation Strategy (“REMS”) that made the drug harder to prescribe, harder to dispense, and harder for patients to obtain. The providers emphasized that medication abortion was especially important after Dobbs because it was less resource-intensive than procedural abortion, could be provided through advanced-practice clinicians and telehealth, and was critical for patients traveling from states with abortion bans. They argued that the January 2023 version of the REMS still rested on no sound scientific basis, stigmatized abortion care, and left providers in non-party states exposed to chaos created by simultaneous litigation in Texas and Washington over mifepristone’s status. The complaint also alleged that requiring the plaintiffs to file yet another FDA citizen petition would be futile because FDA had already refused similar requests and continued to defend the REMS.

The complaint brought four claims. First, the plaintiffs alleged under the Administrative Procedure Act that FDA acted in excess of its statutory authority and contrary to law by continuing to impose the REMS and by promulgating the 2023 REMS, in violation of the Food, Drug, and Cosmetic Act and 5 U.S.C. § 706(2)(C). Second, they alleged that FDA’s actions were arbitrary and capricious under 5 U.S.C. § 706(2)(A). Third, they alleged under 5 U.S.C. § 706(2)(B) that the 2023 REMS was contrary to constitutional right because it treated similarly situated drugs, providers, pharmacists, and patients differently without adequate justification. Fourth, they pleaded an equal protection claim under the Fifth Amendment for treating providers, pharmacists, and patients prescribing, dispensing, or using mifepristone worse than similarly situated individuals. The plaintiffs sought declaratory relief that mifepristone is safe and effective and that its approval is lawful and valid, declaratory relief that the REMS violates the APA and the Constitution, and injunctions barring the federal defendants from enforcing or applying the REMS, including against providers in Virginia, Montana, and Kansas.

The plaintiffs simultaneously moved for a preliminary injunction. The interim relief they sought was narrowerl: rather than immediately removing the REMS while the case was pending, they asked the court to stop the FDA from “altering the status quo” as to mifepristone’s availability under the January 2023 REMS in the states where they operated. In practical terms, they wanted the Court to preserve the then-current access regime while the separate Washington and Texas mifepristone cases continued to unfold. After briefing, a hearing was held on the preliminary injunction motion on June 8, 2023

Judge Ballou denied that preliminary injunction request on August 21, 2023. 2023 WL 5401885. The opinion recognized that mifepristone had long been found safe and effective and that continued access mattered greatly to the plaintiffs and their patients, but it concluded that the demanding standard for preliminary relief had not been met. The court first held that the plaintiffs did have Article III standing at that stage because they had alleged a concrete injury to their practices and patients from FDA’s REMS restrictions. The court also rejected the government’s exhaustion defense, finding that forcing the plaintiffs to submit another citizen petition to FDA would be futile because FDA had repeatedly retained the REMS and had shown no sign of granting the relief sought. Still, the court denied preliminary relief because the plaintiffs had not clearly shown imminent irreparable harm caused by the FDA itself. Judge Ballou reasoned that mifepristone remained available in Virginia, Montana, and Kansas; the FDA had given no indication it was about to restrict access further; and the uncertainty the plaintiffs described stemmed mainly from other litigation, especially Alliance for Hippocratic Medicine v. FDA, 2023 WL 2825871 (N.D. Tex. Apr. 7, 2023), modified in part, 2023 WL 2913725 (5th Cir. Apr. 12, 2023), and the countervailing injunction in Washington v. FDA, 2023 WL 2941567 (E.D. Wash. Apr. 13, 2023). Because the feared harms were too speculative and not fairly traceable to imminent FDA action, no preliminary injunction was issued. The court also took the government’s motion to stay under advisement and directed the parties to confer about the administrative record.

On January 12, 2024, the court stayed the case by agreement pending the U.S. Supreme Court’s decisions in FDA v. Alliance for Hippocratic Medicine and Danco Laboratories, LLC v. Alliance for Hippocratic Medicine, and required the parties to return for a status conference after those decisions. Both cases were dismissed by the U.S. Supreme Court on standing grounds. A status conference followed in this case in July 2024. Thereafter, the plaintiffs moved for summary judgment on October 23, 2024. The defendants opposed and filed a cross-motion for summary judgment on December 18, 2024. The plaintiffs filed a combined opposition/reply on February 4, 2025, and the defendants filed their reply on March 18, 2025. Motions were heard on May 19, 2025.

As of April 2, 2026, the court has yet reached a decision on the motions. The case is ongoing.

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Summary Authors

Ben Hefter (8/18/2025)

Jacob Chang (4/2/2026)

People

For PACER's information on parties and their attorneys, see: https://www.courtlistener.com/docket/67347356/parties/whole-womans-health-alliance-v-united-states-food-and-drug-administration/

Judge(s)

Ballou, Robert S. (Virginia)

Attorney for Plaintiff

Deady, Gail Marie (Virginia)

Goldstein, Linda Ceilia (Virginia)

Attorney for Defendant

Belfer, Isaac (Virginia)

Katzen, Noah T. (Virginia)

Judge(s)

Ballou, Robert S. (Virginia)

Attorney for Plaintiff

Deady, Gail Marie (Virginia)

Goldstein, Linda Ceilia (Virginia)

Muqaddam, Rabia (Virginia)

Attorney for Defendant

Belfer, Isaac (Virginia)

Katzen, Noah T. (Virginia)

Attorney Contact Information via CourtListener

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Documents in the Clearinghouse

	Document
1 3:23-cv-00019	Complaint for Declaratory and Injunctive Relief	May 8, 2023	May 8, 2023 Complaint
42 3:23-cv-00019	Memorandum Opinion	Aug. 21, 2023	Aug. 21, 2023 Order/Opinion 2023 WL 5401885

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Docket

See docket on RECAP: https://www.courtlistener.com/docket/67347356/whole-womans-health-alliance-v-united-states-food-and-drug-administration/

Last updated April 2, 2026, 3:49 p.m.

ECF Number	Description	Date	Link Date / Link
1	COMPLAINT for Declaratory and Injunctive Relief against Xavier Becerra, Robert M Califf, MD, United States Department of Health and Human Services, United States Food and Drug Administration (Filing & Administrative fee $ 402 receipt number AVAWDC-4181412), filed by All Families Healthcare, Whole Woman's Health of the Twin Cities, LLC, Trust Women Foundation, Whole Woman's Health, Blue Mountain Clinic, Whole Woman's Health Alliance, Helen Weems, APRN-FNP. (Attachments: # 1 Exhibit List, # 2 Exhibit A, # 3 Exhibit B, # 4 Exhibit C, # 5 Exhibit D, # 6 Exhibit E, # 7 Exhibit F, # 8 Exhibit G, # 9 Exhibit H, # 10 Exhibit I, # 11 Exhibit J, # 12 Exhibit K, # 13 Exhibit L, # 14 Exhibit M, # 15 Exhibit N, # 16 Exhibit O, # 17 Exhibit P, # 18 Exhibit Q, # 19 Civil Cover Sheet)(skm) 1 Exhibit List View on RECAP 2 Exhibit A View on RECAP 3 Exhibit B View on RECAP 4 Exhibit C View on RECAP 5 Exhibit D View on RECAP 6 Exhibit E View on RECAP 7 Exhibit F View on RECAP 8 Exhibit G View on RECAP 9 Exhibit H View on RECAP 10 Exhibit I View on RECAP 11 Exhibit J View on RECAP 12 Exhibit K View on RECAP 13 Exhibit L View on RECAP 14 Exhibit M View on RECAP 15 Exhibit N View on RECAP 16 Exhibit O View on RECAP 17 Exhibit P View on RECAP 18 Exhibit Q View on RECAP 19 Civil Cover Sheet View on RECAP	May 8, 2023	May 8, 2023 Clearinghouse
2	Negative Corporate Disclosure Statement by Whole Woman's Health (Deady, Gail) (Main Document 2 replaced on 5/9/2023, replaced with flattened document) (skm).	May 8, 2023	May 8, 2023 RECAP
3	Positive Corporate Disclosure Statement by Whole Woman's Health Alliance identifying Corporate Parent The Booyah Group, LLC for Whole Woman's Health Alliance. (Deady, Gail) (Main Document 3 replaced on 5/9/2023, replaced with flattened document) (skm).	May 8, 2023	May 8, 2023 RECAP
4	Positive Corporate Disclosure Statement by Whole Woman's Health of the Twin Cities, LLC identifying Corporate Parent The Booyah Group, LLC for Whole Woman's Health of the Twin Cities, LLC. (Deady, Gail) (Main Document 4 replaced on 5/9/2023, replaced with flattened document) (skm).	May 8, 2023	May 8, 2023 RECAP
5	Negative Corporate Disclosure Statement by Blue Mountain Clinic (Deady, Gail) (Main Document 5 replaced on 5/9/2023, replaced with flattened document) (skm).	May 8, 2023	May 8, 2023 RECAP
6	Negative Corporate Disclosure Statement by All Families Healthcare (Deady, Gail) (Main Document 6 replaced on 5/9/2023, replaced with flattened document) (skm).	May 8, 2023	May 8, 2023 RECAP
7	Negative Corporate Disclosure Statement by Trust Women Foundation (Deady, Gail) (Main Document 7 replaced on 5/9/2023, replaced with flattened document) (skm).	May 8, 2023	May 8, 2023 RECAP
8	MOTION for Preliminary Injunction by All Families Healthcare, Blue Mountain Clinic, Trust Women Foundation, Helen Weems, APRN-FNP, Whole Woman's Health, Whole Woman's Health Alliance, Whole Woman's Health of the Twin Cities, LLC. (Attachments: # 1 Text of Proposed Order)(Deady, Gail) 1 Text of Proposed Order View on RECAP	May 8, 2023	May 8, 2023 RECAP
9	Electronic Summons Issued as to Xavier Becerra, Robert M Califf, MD, United States Department of Health and Human Services, United States Food and Drug Administration. NOTICE TO COUNSEL: Please print copies of the electronically issued summons for each defendant as necessary to effectuate service under Fed. R. Civ. P. 4. (Attachments: # 1 Summons Issued, # 2 Summons Issued, # 3 Summons Issued, # 4 Summons Issued, # 5 Summons Issued, # 6 Summons Issued, # 7 Summons Issued, # 8 Summons Issued)(skm) Corrected docket text on 5/8/2023. (skm) 1 Summons Issued View on RECAP 2 Summons Issued View on RECAP 3 Summons Issued View on RECAP 4 Summons Issued View on RECAP 5 Summons Issued View on RECAP 6 Summons Issued View on RECAP 7 Summons Issued View on RECAP 8 Summons Issued View on RECAP	May 8, 2023	May 8, 2023 RECAP
10	Brief / Memorandum in Support re 8 MOTION for Preliminary Injunction . filed by All Families Healthcare, Blue Mountain Clinic, Trust Women Foundation, Helen Weems, APRN-FNP, Whole Woman's Health, Whole Woman's Health Alliance, Whole Woman's Health of the Twin Cities, LLC. (Attachments: # 1 Exhibit 1, # 2 Exhibit 2, # 3 Exhibit 3, # 4 Exhibit 4)(Deady, Gail) 1 Exhibit 1 View on PACER 2 Exhibit 2 View on PACER 3 Exhibit 3 View on PACER 4 Exhibit 4 View on PACER	May 8, 2023	May 8, 2023 RECAP
11	MOTION for Rabia Muqaddam to Appear Pro Hac Vice. Filing fee $ 100, receipt number AVAWDC-4182073. by All Families Healthcare, Blue Mountain Clinic, Trust Women Foundation, Helen Weems, APRN-FNP, Whole Woman's Health, Whole Woman's Health Alliance, Whole Woman's Health of the Twin Cities, LLC. (Attachments: # 1 Text of Proposed Order)(Deady, Gail) 1 Text of Proposed Order View on RECAP	May 8, 2023	May 8, 2023 RECAP
12	CERTIFICATE OF SERVICE by All Families Healthcare, Blue Mountain Clinic, Trust Women Foundation, Helen Weems, APRN-FNP, Whole Woman's Health, Whole Woman's Health Alliance, Whole Woman's Health of the Twin Cities, LLC re 9 Summons Issued,, (Deady, Gail)	May 8, 2023	May 8, 2023 RECAP
13	ORAL ORDER granting 11 MOTION to Appear Pro Hac Vice: Upon consideration of the motion of Rabia Muqaddam to appear pro hac vice, and finding the requirements for pro hac vice admission have been satisfied and for good cause shown, the Court grants the motion. Dkt. 11. Ms. Muqaddam may appear and practice pro hac vice in this matter as counsel for Plaintiffs. See W.D. Va. Gen. R. 6(d). Entered by Senior Judge Norman K. Moon on 5/9/2023. This Notice of Electronic Filing is the Official ORDER for this entry. No document is attached.(skm)	May 9, 2023	May 9, 2023
14	ORAL ORDER regarding 12 Certificate of Service filed by Trust Women Foundation, All Families Healthcare, Helen Weems, APRN-FNP, Whole Woman's Health of the Twin Cities, LLC, Whole Woman's Health, Blue Mountain Clinic, Whole Woman's Health Alliance: Plaintiffs counsel shall file a supplemental certificate of service demonstrating service upon the U.S. Attorney's Office in Charlottesville, when such service has been effected. See Fed. R. Civ. P. 4(i)(1)-(2). Entered by Senior Judge Norman K. Moon on 5/9/2023. This Notice of Electronic Filing is the Official ORDER for this entry. No document is attached.(skm)	May 9, 2023	May 9, 2023
15	SUMMONS Returned Executed by All Families Healthcare, Whole Woman's Health of the Twin Cities, LLC, Trust Women Foundation, Whole Woman's Health, Blue Mountain Clinic, Whole Woman's Health Alliance, Helen Weems, APRN-FNP. All Defendants.(Deady, Gail)	May 9, 2023	May 9, 2023 RECAP
16	NOTICE of Appearance by Rabia Muqaddam on behalf of All Plaintiffs (Muqaddam, Rabia)	May 9, 2023	May 9, 2023 RECAP
	Order	May 9, 2023	May 9, 2023
	Order on Motion to Appear Pro Hac Vice	May 9, 2023	May 9, 2023
	Attorney - Updating Contact Information	May 12, 2023	May 12, 2023
	Gail M. Deady, in accordance with Section B.9. of the Administrative Procedures for Filing, Signing and Verifying Pleadings and Papers by Electronic Means, a registered user is responsible for ensuring their mailing address, primary email address, and telephone number are kept up-to-date with this court by updating the information in their PACER account. To update your information, log into PACER.gov and click the Maintenance tab to Update this information with this court. (ca)	May 12, 2023	May 12, 2023
17	NOTICE of Appearance by Noah T. Katzen on behalf of Xavier Becerra, Robert M Califf, MD, United States Department of Health and Human Services, United States Food and Drug Administration (Katzen, Noah)	May 16, 2023	May 16, 2023
18	Emergency MOTION for Extension of Time to File Response/Reply to 8 Motion for Preliminary Injunction by Xavier Becerra, Robert M Califf, MD, United States Department of Health and Human Services, United States Food and Drug Administration. (Attachments: # 1 Text of Proposed Order)(Katzen, Noah) Modified on 5/17/2023 (skm). 1 Text of Proposed Order View on RECAP	May 16, 2023	May 16, 2023 RECAP
19	RESPONSE in Opposition re 18 Emergency MOTION for Extension of Time to File Response/Reply . filed by All Families Healthcare, Blue Mountain Clinic, Trust Women Foundation, Helen Weems, APRN-FNP, Whole Woman's Health, Whole Woman's Health Alliance, Whole Woman's Health of the Twin Cities, LLC. (Muqaddam, Rabia)	May 16, 2023	May 16, 2023 RECAP
20	ORAL ORDER TRANSFERRING CASE. It is hereby ORDERED that this matter shall be TRANSFERRED to the docket of the Honorable Robert S. Ballou, United States District Judge for the Western District of Virginia, for all further action. Senior Judge Norman K. Moon is no longer assigned to the case. Entered by Senior Judge Norman K. Moon on May 16, 2023. This Notice of Electronic Filing is the Official ORDER for this entry. No document is attached.(ca)	May 16, 2023	May 16, 2023
	Order Transferring Case to Another Judge	May 16, 2023	May 16, 2023
21	NOTICE of Hearing: (N) In Chambers Conference set for 5/17/2023 05:00 PM in by telephone conference before District Judge Robert S. Ballou. (kab)	May 17, 2023	May 17, 2023
22	NOTICE of Hearing on Motion 8 MOTION for Preliminary Injunction : (CR) Motion Hearing set for 6/8/2023 11:00 AM in Charlottesville before District Judge Robert S. Ballou. (kab)	May 17, 2023	May 17, 2023
23	ORAL ORDER granting 18 Motion for Extension of Time to File Response/Reply to the extent that Defendants' response shall be due by the close of business on June 5, 2023. A supplemental briefing schedule will be discussed at the hearing on the Motion for a Preliminary Injunction (Dkt. 8), which is scheduled for June 8, 2023. Entered by District Judge Robert S. Ballou on 05/17/2023. This Notice of Electronic Filing is the Official ORDER for this entry. No document is attached.(cmh)	May 17, 2023	May 17, 2023
	Notice of Hearing	May 17, 2023	May 17, 2023
	Order on Motion for Extension of Time to File Response/Reply	May 17, 2023	May 17, 2023
	Notice of Hearing on Motion	May 17, 2023	May 17, 2023
24	NOTICE of Appearance by Isaac Belfer on behalf of All Defendants (Belfer, Isaac)	June 5, 2023	June 5, 2023 RECAP
25	MOTION to Stay Proceedings by Xavier Becerra, Robert M Califf, MD, United States Department of Health and Human Services, United States Food and Drug Administration. (Attachments: # 1 Text of Proposed Order)(Katzen, Noah) Modified on 11/28/2023 to remove referral at the direction of chambers. (kab). Modified on 7/25/2024 (kab) motion terminated by DE 54 . 1 Text of Proposed Order View on RECAP	June 5, 2023	June 5, 2023
26	Brief/Memorandum in Opposition to Motion for Preliminary Injunction and in Support of Motion to Stay Proceedings. filed by Xavier Becerra, Robert M Califf, MD, United States Department of Health and Human Services, United States Food and Drug Administration. (Attachments: # 1 Exhibit Katzen Declaration and Exhibits)(Katzen, Noah) 1 Exhibit Katzen Declaration and Exhibits View on RECAP	June 5, 2023	June 5, 2023
27	Amended Brief/Memorandum in Opposition to 8 Motion for Preliminary Injunction and in Support of 25 Motion to Stay Proceedings (AMENDED AND CORRECTED) filed by Xavier Becerra, Robert M Califf, MD, United States Department of Health and Human Services, United States Food and Drug Administration. (Attachments: # 1 Exhibit Katzen Declaration and Exhibits)(Katzen, Noah) Modified on 6/5/2023, corrected docket text to add links to motions(skm). 1 Exhibit Katzen Declaration and Exhibits View on RECAP	June 5, 2023	June 5, 2023 RECAP
28	NOTICE of Hearing on 8 MOTION for Preliminary Injunction : (CR) . Motion Hearing set for 6/8/2023 11:00 AM in Charlottesville before District Judge Robert S. Ballou. (kld) Modified on 6/6/2023 to remove motion - Motion to Stay will NOT be heard at this hearing. (kld).	June 6, 2023	June 6, 2023
	Notice of Hearing on Motion	June 6, 2023	June 6, 2023
30	Minute Entry for proceedings held before District Judge Robert S. Ballou: Motion Hearing held on 6/8/2023 re 8 MOTION for Preliminary Injunction filed by Trust Women Foundation, All Families Healthcare, Helen Weems, APRN-FNP, Whole Woman's Health of the Twin Cities, LLC, Whole Woman's Health, Blue Mountain Clinic, Whole Woman's Health Alliance. (Court Reporter: Lisa Blair, OCR) (kld) (Entered: 06/09/2023)	June 8, 2023	June 8, 2023 RECAP
29	ORDER for Briefing Schedule regarding 8 MOTION for Preliminary Injunction and 25 MOTION to Stay Proceedings. Signed by District Judge Robert S. Ballou on 6/9/2023. (skm)	June 9, 2023	June 9, 2023 RECAP
31	TRANSCRIPT REQUEST (Daily Service) by Xavier Becerra, Robert M Califf, MD, United States Department of Health and Human Services, United States Food and Drug Administration for Hearing on Motion for Preliminary Injunction held on June 8, 2023 reported by Court Reporter Lisa Blair before Judge Robert S. Ballou. Transcript Due Deadline will be set when Financial Arrangements are made. (Katzen, Noah)	June 13, 2023	June 13, 2023 RECAP
32	TRANSCRIPT REQUEST (Daily Service) by All Families Healthcare, Blue Mountain Clinic, Trust Women Foundation, Helen Weems, APRN-FNP, Whole Woman's Health, Whole Woman's Health Alliance, Whole Woman's Health of the Twin Cities, LLC for Hearing on Motion for Preliminary Injunction held on June 8, 2023 reported by Court Reporter Lisa Blair before Judge Judge R. S. Ballou. Transcript Due Deadline will be set when Financial Arrangements are made. (Muqaddam, Rabia)	June 13, 2023	June 13, 2023 RECAP
33	Reply In Support of Plaintiffs' Motion for Preliminary Injunction, RESPONSE in Opposition re 25 MOTION to Stay Proceedings, 8 MOTION for Preliminary Injunction . filed by All Families Healthcare, Blue Mountain Clinic, Trust Women Foundation, Helen Weems, APRN-FNP, Whole Woman's Health, Whole Woman's Health Alliance, Whole Woman's Health of the Twin Cities, LLC. (Muqaddam, Rabia)	June 15, 2023	June 15, 2023 RECAP
34	Financial arrangements made (Original) (3 Days Service) re 31 Transcript Request, Transcript due by 6/22/2023. (lmb)	June 19, 2023	June 19, 2023
35	Financial arrangements made (Copy) (3 Days Service) re 32 Transcript Request,, Transcript due by 6/22/2023. (lmb)	June 19, 2023	June 19, 2023
	Financial Arrangements Made	June 19, 2023	June 19, 2023
36	Transcript Copy Delivered re 32 Transcript Request,, (lmb)	June 21, 2023	June 21, 2023
37	TRANSCRIPT of Proceedings: Motions hearing held on 6/8/2023 before Judge Robert S. Ballou. Court Reporter/Transcriber Lisa Blair, Telephone number 434.409.4575. NOTICE RE REDACTION OF TRANSCRIPTS: The parties have seven (7) calendar days to file with the Court a Notice of Intent to Request Redaction of this transcript. If no such Notice is filed, the transcript will be made remotely electronically available to the public without redaction after 90 calendar days. The policy is located on our website at www.vawd.uscourts.gov. Transcript may be viewed at the court public terminal or purchased through Court Reporter/Transcriber before the deadline for Release of Transcript Restriction. After that date it may be obtained through PACER unless a Redacted Transcript has been filed. Redaction Request due 7/12/2023. Redacted Transcript Deadline set for 7/24/2023. Release of Transcript Restriction set for 9/19/2023. (lmb)	June 21, 2023	June 21, 2023 RECAP
	Transcript Copy Delivered	June 21, 2023	June 21, 2023
38	Joint MOTION to Stay Defendants Answer or Response Deadline by Xavier Becerra, Robert M Califf, MD, United States Department of Health and Human Services, United States Food and Drug Administration. (Belfer, Isaac)	June 27, 2023	June 27, 2023 RECAP
39	ORDER granting 38 Motion to Stay Defendants Answer or Response Deadline pending the Court's resolution of the Plaintiffs' pending Motion for Preliminary Injunction. Signed by District Judge Robert S. Ballou on 6/28/2023. (jv)	June 28, 2023	June 28, 2023 RECAP
40	Supplemental Brief / Memorandum in Opposition re 8 MOTION for Preliminary Injunction, Reply re 25 MOTION to Stay Proceedings . filed by Xavier Becerra, Robert M Califf, MD, United States Department of Health and Human Services, United States Food and Drug Administration. (Belfer, Isaac)	June 30, 2023	June 30, 2023 RECAP
41	Supplemental Reply re 8 MOTION for Preliminary Injunction . filed by All Families Healthcare, Blue Mountain Clinic, Trust Women Foundation, Helen Weems, APRN-FNP, Whole Woman's Health, Whole Woman's Health Alliance, Whole Woman's Health of the Twin Cities, LLC. (Muqaddam, Rabia)	July 7, 2023	July 7, 2023 RECAP
42	MEMORANDUM OPINION. Signed by District Judge Robert S. Ballou on 8/21/2023. (skm) (Entered: 08/22/2023)	Aug. 21, 2023	Aug. 21, 2023 Clearinghouse
43	ORDER denying 8 Motion for Preliminary Injunction. Defendants' 25 Motion to Stay is taken under advisement. The Parties shall schedule a status conference to discuss a timeline for production of the administrative record within 30 days after this Order is issued. Signed by District Judge Robert S. Ballou on 8/21/2023. (skm) (Entered: 08/22/2023)	Aug. 21, 2023	Aug. 21, 2023 RECAP
44	NOTICE of Hearing: (N) Status Conference set for 9/19/2023 09:00 AM in by telephone conference before District Judge Robert S. Ballou. (kab)	Sept. 5, 2023	Sept. 5, 2023
45	Notice Rescheduling Hearing (CHANGE IN TIME ONLY)(N) previously set for 9/19/2023 at 9:00am before Judge Ballou in Roanoke Status Conference set for 9/19/2023 09:30 AM in by telephone conference before District Judge Robert S. Ballou. (kab)	Sept. 5, 2023	Sept. 5, 2023
46	NOTICE by Xavier Becerra, Robert M Califf, MD, United States Department of Health and Human Services, United States Food and Drug Administration Certified Index to Administrative Record (Katzen, Noah)	Sept. 5, 2023	Sept. 5, 2023 RECAP
47	STATUS REPORT by Xavier Becerra, Robert M Califf, MD, United States Department of Health and Human Services, United States Food and Drug Administration (Katzen, Noah)	Sept. 5, 2023	Sept. 5, 2023 RECAP
	Notice of Hearing	Sept. 5, 2023	Sept. 5, 2023
	Notice Rescheduling Hearing	Sept. 5, 2023	Sept. 5, 2023
48	Minute Entry for proceedings held before District Judge Robert S. Ballou: In Chambers Status Conference held via telephone conference on 9/19/2023. (ham)	Sept. 19, 2023	Sept. 19, 2023
	Status Conference	Sept. 19, 2023	Sept. 19, 2023
49	ORDER: The parties are directed to schedule a status conference within 30 days of the Supreme Court's disposition on a writ of certiorari and to submit a joint status report 48 hours before the scheduled status conference. Signed by District Judge Robert S. Ballou on 9/20/2023. (skm)	Sept. 20, 2023	Sept. 20, 2023 RECAP
50	ORAL Order-All non-dispositive pretrial motions and issues in this case shall be and are hereby REFERRED to U.S. Magistrate Judge Joel C. Hoppe, pursuant to 28 U.S.C. § 636(b)(1)(A). Entered by District Judge Robert S. Ballou on 10/11/2023. This Notice of Electronic Filing is the Official ORDER for this entry. No document is attached.(slt)	Oct. 11, 2023	Oct. 11, 2023
	Order Referring Case to Magistrate Judge	Oct. 11, 2023	Oct. 11, 2023
51	STATUS REPORT by Xavier Becerra, Robert M Califf, MD, United States Department of Health and Human Services, United States Food and Drug Administration (Katzen, Noah)	Jan. 2, 2024	Jan. 2, 2024 RECAP
52	NOTICE of Hearing: (CR) (Click on this link for guidance for participation via Zoom and Click on this link for instructions on how to listen to public hearings) Status Conference set for 1/19/2024 01:00 PM in via Zoom before District Judge Robert S. Ballou. (kab)	Jan. 2, 2024	Jan. 2, 2024
	Notice of Hearing	Jan. 2, 2024	Jan. 2, 2024
53	Notice of Cancellation of 1/19/2024 Status Conference (Cancel Court Reporter) (kab)	Jan. 10, 2024	Jan. 10, 2024
	Notice of Cancellation of Hearing	Jan. 10, 2024	Jan. 10, 2024
54	ORAL ORDER STAYING CASE The parties filed a status report on January 2, 2024, and agreed to stay this case pending the United States Supreme Court's decisions in FDA v. Alliance for Hippocratic Medicine, No. 23-235, and Danco Laboratories, LLC v. Alliance for Hippocratic Medicine, No 23-236. Accordingly, this case is stayed pending the resolution of FDA v. Alliance for Hippocratic Medicine, No. 23-235, and Danco Laboratories, LLC v. Alliance for Hippocratic Medicine, No 23-236 and the parties are instructed to schedule a status conference with this Court 30 days after the Supreme Court issues its opinion(s) in those cases. The parties shall also submit a joint status report no less than 48 hours before the scheduled status conference. Entered by District Judge Robert S. Ballou on 1/12/2024. This Notice of Electronic Filing is the Official ORDER for this entry. No document is attached.(mlb)	Jan. 12, 2024	Jan. 12, 2024
	Order Staying Case	Jan. 12, 2024	Jan. 12, 2024
55	NOTICE of Hearing: (Zoom) NOTICE TO COUNSEL This hearing has been set for one hour. If you think the hearing will take longer than one hour please contact the Courtroom Deputy as soon as possible. (Click on this link for guidance for participation via Zoom and Click on this link for instructions on how to listen to public hearings) Status Conference set for 7/15/2024 10:00 AM in via Zoom before District Judge Robert S. Ballou. (kab)	July 8, 2024	July 8, 2024
	Notice of Hearing	July 8, 2024	July 8, 2024
56	STATUS REPORT (Joint) by Xavier Becerra, Robert M Califf, MD, United States Department of Health and Human Services, United States Food and Drug Administration (Katzen, Noah)	July 12, 2024	July 12, 2024 RECAP
57	Minute Entry for proceedings held before District Judge Robert S. Ballou: Status Conference held on 7/15/2024. (Court Reporter: L. Blair) (kab)	July 15, 2024	July 15, 2024 RECAP
58	NOTICE of Hearing: (CR) (Click on this link for guidance for participation via Zoom and Click on this link for instructions on how to listen to public hearings) Status Conference set for 5/8/2025 10:00 AM in via Zoom before District Judge Robert S. Ballou. (kab)	July 17, 2024	July 17, 2024
	Notice of Hearing	July 17, 2024	July 17, 2024
59	MOTION for Linda Goldstein to Appear Pro Hac Vice. Filing fee $ 100, receipt number AVAWDC-4475800. by All Families Healthcare, Blue Mountain Clinic, Trust Women Foundation, Helen Weems, APRN-FNP, Whole Woman's Health, Whole Woman's Health Alliance, Whole Woman's Health of the Twin Cities, LLC. Motions referred to Judge Joel C. Hoppe. (Attachments: # 1 Text of Proposed Order)(Deady, Gail) 1 Text of Proposed Order View on RECAP	July 25, 2024	July 25, 2024 RECAP
60	MOTION to Withdraw as Attorney Rabia Muqaddam by All Families Healthcare, Blue Mountain Clinic, Trust Women Foundation, Helen Weems, APRN-FNP, Whole Woman's Health, Whole Woman's Health Alliance, Whole Woman's Health of the Twin Cities, LLC. Motions referred to Judge Joel C. Hoppe. (Attachments: # 1 Text of Proposed Order)(Deady, Gail) 1 Text of Proposed Order View on RECAP	July 25, 2024	July 25, 2024 RECAP
61	ORAL ORDER granting 59 MOTION for Linda Goldstein to Appear Pro Hac Vice in this case. Entered by Magistrate Judge Joel C. Hoppe on 8/12/24. This Notice of Electronic Filing is the Official ORDER for this entry. No document is attached. (The Clerk is directed to mail a copy of this Order to any applicable pro se party/parties via US Mail)(JCH)	Aug. 12, 2024	Aug. 12, 2024
62	ORAL ORDER granting 60 Motion to Withdraw as Attorney. Attorney Rabia Muqaddam terminated. Entered by Magistrate Judge Joel C. Hoppe on 8/12/24. This Notice of Electronic Filing is the Official ORDER for this entry. No document is attached. (The Clerk is directed to mail a copy of this Order to any applicable pro se party/parties via US Mail)(JCH)	Aug. 12, 2024	Aug. 12, 2024
	Order on Motion to Withdraw as Attorney	Aug. 12, 2024	Aug. 12, 2024
	Order on Motion to Appear Pro Hac Vice	Aug. 12, 2024	Aug. 12, 2024
63	NOTICE of Appearance by Linda Ceilia Goldstein on behalf of All Plaintiffs (Goldstein, Linda)	Aug. 14, 2024	Aug. 14, 2024
	Notice of Appearance	Aug. 14, 2024	Aug. 14, 2024
64	Magistrate Consent Notice to Parties. Click here to access the Consent Form (mcs)	Aug. 15, 2024	Aug. 15, 2024
	E-Magistrate Consent Notice to Parties	Aug. 15, 2024	Aug. 15, 2024
65	NOTICE by Xavier Becerra, Robert M Califf, MD, United States Department of Health and Human Services, United States Food and Drug Administration Amended Certified Index to the Administrative Record (Katzen, Noah)	Sept. 4, 2024	Sept. 4, 2024 RECAP
66	MOTION to Withdraw as Attorney by Xavier Becerra, Robert M Califf, MD, United States Department of Health and Human Services, United States Food and Drug Administration. Motions referred to Judge Joel C. Hoppe. (Attachments: # 1 Text of Proposed Order)(Belfer, Isaac)	Sept. 13, 2024	Sept. 13, 2024
67	ORAL ORDER granting 66 Motion to Withdraw as Attorney. Attorney Isaac Belfer terminated. Entered by Magistrate Judge Joel C. Hoppe on 9/16/24. This Notice of Electronic Filing is the Official ORDER for this entry. No document is attached. (The Clerk is directed to mail a copy of this Order to any applicable pro se party/parties via US Mail)(JCH)	Sept. 16, 2024	Sept. 16, 2024
	Order on Motion to Withdraw as Attorney	Sept. 16, 2024	Sept. 16, 2024
68	MOTION for Summary Judgment by All Families Healthcare, Blue Mountain Clinic, Trust Women Foundation, Helen Weems, APRN-FNP, Whole Woman's Health, Whole Woman's Health Alliance, Whole Woman's Health of the Twin Cities, LLC. (Attachments: # 1 Text of Proposed Order)(Goldstein, Linda) 1 Text of Proposed Order View on RECAP	Oct. 23, 2024	Oct. 23, 2024 RECAP
69	MOTION for Summary Judgment Memorandum of Law in Support by All Families Healthcare, Blue Mountain Clinic, Trust Women Foundation, Helen Weems, APRN-FNP, Whole Woman's Health, Whole Woman's Health Alliance, Whole Woman's Health of the Twin Cities, LLC. (Goldstein, Linda)	Oct. 23, 2024	Oct. 23, 2024 RECAP
70	RESPONSE in Opposition re 68 MOTION for Summary Judgment, 69 MOTION for Summary Judgment Memorandum of Law in Support . filed by United States Department of Health and Human Services, Xavier Becerra, United States Food and Drug Administration, Robert M Califf, MD. (Katzen, Noah)	Dec. 18, 2024	Dec. 18, 2024 RECAP
71	Cross MOTION for Summary Judgment by United States Department of Health and Human Services, Xavier Becerra, United States Food and Drug Administration, Robert M Califf, MD. (Attachments: # 1 Defendants' Combined Memorandum of Law in Support of Cross-Motion for Summary Judgment and in Opposition to Plaintiffs' Motion for Summary Judgment, # 2 Text of Proposed Order)(Katzen, Noah) 1 Defendants' Combined Memorandum of Law in Support of Cross-Motion for Summ View on PACER 2 Text of Proposed Order View on PACER	Dec. 18, 2024	Dec. 18, 2024
72	SCHEDULING ORDER. Signed by District Judge Robert S. Ballou on January 2, 2025. (dsa)	Jan. 2, 2025	Jan. 2, 2025 RECAP
73	Notice Rescheduling Hearing (CR) previously set for 5/8/2025 at 10:00am before Judge Ballou in ZOOM (Click on this link for guidance for participation via Zoom and Click on this link for instructions on how to listen to public hearings) Status Conference rescheduled for 5/19/2025 10:00 AM in via Zoom before District Judge Robert S. Ballou. (kab)	Jan. 3, 2025	Jan. 3, 2025
	Notice Rescheduling Hearing	Jan. 3, 2025	Jan. 3, 2025
74	Reply re 68 MOTION for Summary Judgment, 71 Cross MOTION for Summary Judgment . filed by All Families Healthcare, Blue Mountain Clinic, Trust Women Foundation, Helen Weems, APRN-FNP, Whole Woman's Health, Whole Woman's Health Alliance, Whole Woman's Health of the Twin Cities, LLC. (Attachments: # 1 Declaration in Support Decl. of Amy Hagstrom Miller, # 2 Declaration in Support Decl. of Joey Banks M.D., # 3 Declaration in Support Decl. of Helen Weems MSN, APRN-FNP, # 4 Declaration in Support Decl. of Jessica Wannemacher)(Goldstein, Linda) 1 Declaration in Support Decl. of Amy Hagstrom Miller View on PACER 2 Declaration in Support Decl. of Joey Banks M.D. View on PACER 3 Declaration in Support Decl. of Helen Weems MSN, APRN-FNP View on PACER 4 Declaration in Support Decl. of Jessica Wannemacher View on PACER	Feb. 4, 2025	Feb. 4, 2025 RECAP

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Case Details

State / Territory:

Virginia

Case Type(s):

Healthcare Access and Reproductive Issues

Key Dates

Filing Date: May 8, 2023

Case Ongoing: Yes

Plaintiffs

Plaintiff Description:

A coalition of independent abortion providers

Plaintiff Type(s):

Private Plaintiff

Attorney Organizations:

Center for Reproductive Rights

Public Interest Lawyer: Yes

Filed Pro Se: No

Class Action Sought: No

Class Action Outcome: Not sought

Defendants

Federal

Commissioner Robert M. Califf

FDA

HHS

Secretary Xavier Becerra

Defendant Type(s):

Hospital/Health Department

Case Details

Causes of Action:

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

Constitutional Clause(s):

Equal Protection

Other Dockets:

Western District of Virginia 3:23-cv-00019

Available Documents:

Complaint (any)

Injunctive (or Injunctive-like) Relief

Trial Court Docket

Outcome

Prevailing Party: None Yet / None

Relief Sought:

Declaratory judgment

Injunction

Relief Granted:

None yet

Source of Relief:

None yet

Issues

Reproductive rights:

Abortion

Access (physical)

Contraception

Licensing restriction

Medication abortion

Reproductive health care (including birth control, abortion, and others)

Recommended Citation

Case Summary of Whole Woman's Health Alliance v. United States Food and Drug Administration, Civil Rights Litig. Clearinghouse, https://clearinghouse.net/case/46865/ (last updated 4/2/2026).