Case: Louisiana v. U S Food & Drug Administration

6:25-cv-01491 | U.S. District Court for the Western District of Louisiana

Filed Date: Oct. 6, 2025

Case Ongoing

Clearinghouse coding complete

Case Summary

This case challenged a Biden Administration agency action which allegedly allowed residents in states where abortion rules were more lenient to mail mifepristone, an abortion pill, to residents in Louisiana, where nearly all abortions were banned. Louisiana banned nearly all abortions after the 2022 decision of the Supreme Court of the United States in Dobbs v. Jackson Women’s Health Organization, which allowed states to control over abortion laws. In 2023, the FDA, under the Biden Administrat…

Louisiana banned nearly all abortions after the 2022 decision of the Supreme Court of the United States in Dobbs v. Jackson Women’s Health Organization, which allowed states to control over abortion laws. In 2023, the FDA, under the Biden Administration, removed the in-person dispensing requirement from its Risk Evaluation and Mitigation Strategy (REMS) for mifepristone. Among other things, this meant that mifepristone could be mail ordered and sent into Louisiana despite strict anti-abortion rules.

On October 6, 2025, the State of Louisiana and an individual, Rosalie Markezich, filed suit against the U.S. Food & Drug Administration (FDA) and the U.S. Department of Health and Human Services (HHS), along with several individuals acting in their official capacity within those agencies in the U.S. District Court in the Western District of Louisiana. Louisiana was represented by its Attorney General and Ms. Markezich was represented by a private law firm. Lawyers from Alliance Defending Freedom also joined the Plaintiffs’ team. Plaintiffs claimed that extra-territorial mailing of abortion drugs into Louisiana was illegal under state law because it allowed women to obtain illegal abortions. Plaintiffs alleged that this extra-territorial mailing was the direct result of the Biden Administration’s 2023 agency action expressly facilitating this scheme. Further, they claimed that by removing the in-person requirement for mifepristone, the drug can more easily be acquired by bad actors. Specifically, Ms. Markezich alleged that her boyfriend obtained mifepristone via mail and, “under immense pressure and fearing for her safety,” she took the drug.

Plaintiffs brought suit under the Administrative Procedure Act (APA) and the Federal Food, Drug, and Cosmetic Act (FDCA). They claimed that the 2023 REMS adjustment was arbitrary and capricious, an abuse of discretion, and “otherwise not in accordance with law” under the APA. Plaintiffs sought declaratory, injunctive, vacatur, and other appropriate relief, including attorneys' fees.

The case was assigned to Judge David C. Joseph and Magistrate Judge David J. Ayo on October 6.

This case is ongoing.

show full summary

Summary Authors

Claire Pollard (10/7/2025)

Madeline Kaplan (10/17/2025)

People

For PACER's information on parties and their attorneys, see: https://www.courtlistener.com/docket/71544002/parties/louisiana-v-u-s-food-drug-administration/

Attorney for Plaintiff

Baptist, Erik C (Louisiana)

Basgall, Frank W (Louisiana)

Blake, Julie Marie (Louisiana)

Hawley, Erin Morrow (Louisiana)

Huettemann, Caitlin Ann (Louisiana)

Attorney for Plaintiff

Baptist, Erik C (Louisiana)

Basgall, Frank W (Louisiana)

Blake, Julie Marie (Louisiana)

Hawley, Erin Morrow (Louisiana)

Huettemann, Caitlin Ann (Louisiana)

Johnson, Michael T (Louisiana)

McIntyre, Gabriella M (Louisiana)

Nichols, Dalton A (Louisiana)

Attorney Contact Information via CourtListener

show all people

Documents in the Clearinghouse

	Document
1 6:25-cv-01491	Complaint	Oct. 6, 2025	Oct. 6, 2025 Complaint

show / hide documents

Docket

See docket on RECAP: https://www.courtlistener.com/docket/71544002/louisiana-v-u-s-food-drug-administration/

Last updated Jan. 17, 2026, 12:49 a.m.

ECF Number	Description	Date	Link Date / Link
1	COMPLAINT against U S Food & Drug Administration, U S Dept of Health & Human Services, Robert F Kennedy, Jr, Martin Makary, George Francis Tidmarsh (Filing fee $405, receipt number ALAWDC-6416152) filed by State Louisiana, Rosalie Markezich. (Attachments: # 1 Exhibit 1: Society of Family Planning, # 2 Exhibit 2: Society of Family Planning, # 3 Exhibit 3: 2021 FDA Letter, # 4 Exhibit 4: Dr. Margaret Carpenter indictment, # 5 Exhibit 5: Center for Drug Evaluation & Research Application, # 6 Exhibit 6: Mifepristone, StatPearls, # 7 Exhibit 7: The Facts on Mifepristone, # 8 Exhibit 8: Medication Abortion, # 9 Exhibit 9: 2023 FDA-Approved Label, # 10 Exhibit 10: 2021 FDA Letter to AAPLOG, # 11 Exhibit 11: Center for Drug Evaluation & Research Application, # 12 Exhibit 12: Comparison of rates, # 13 Exhibit 13: Abortion Pill Harms Women, # 14 Exhibit 14: Comparative Acuity, # 15 Exhibit 15: Will a doctor be able to tell, # 16 Exhibit 16: How do you know # 17 Exhibit 17: Am. Coll. of Obstetricians & Gynecologists Practice, # 18 Exhibit 18: #AbortionChangesYou, # 19 Exhibit 19: Population Council, # 20 Exhibit 20: 2002 Citizen Petition, # 21 Exhibit 21: Robert OHarrow Jr, # 22 Exhibit 22: Hannah Levintova, # 23 Exhibit 23: Letter from Center for Drug Evaluation, # 24 Exhibit 24: 2000 FDA Approval Letter, # 25 Exhibit 25: 2019 FDA ANDA Approval Letter, # 26 Exhibit 26: FDA Center for Drug Evaluation, # 27 Exhibit 27: 2000 FDA Approval Memo, # 28 Exhibit 28: Identification of Drug & Biological Products, # 29 Exhibit 29: 2011 FDA Supplemental Approval Letter, # 30 Exhibit 30: 2011 REMS for NDA, # 31 Exhibit 31: 2016 FDA Letter to AAPLOG, # 32 Exhibit 32: 2020 Letter from ACOG, # 33 Exhibit 33: Students for Life of America, # 34 Exhibit 34: 2023 FDA Letter to Students, # 35 Exhibit 35: 2021 FDA Center for Drug Evaluation, # 36 Exhibit 36: Oral History Interview, # 37 Exhibit 37: White House, Readout, # 38 Exhibit 38: White House, Press Briefing, # 39 Exhibit 39: Ian Millhiser, # 40 Exhibit 40: White House, Remarks by President Biden Before, # 41 Exhibit 41: White House, Remarks by President Biden, # 42 Exhibit 42: White House, FACT SHEET, # 43 Exhibit 43: White House, Remarks by President Biden, # 44 Exhibit 44: Exec. Order No. 14076, # 45 Exhibit 45: Exec. Order No. 14079, # 46 Exhibit 46: Presidential Memorandum, # 47 Exhibit 47: White House, FACT SHEET, # 48 Exhibit 48: Press Release, HHS, HHS, # 49 Exhibit 49: Press Release, HHS, # 50 Exhibit 50: Center for Drug Evaluation & Research, Application Number: 020687O, # 51 Exhibit 51: Center for Drug Evaluation & Research, Application Numbers: 020687, # 52 Exhibit 52: FDA Adverse Events Reporting, # 53 Exhibit 53: Kathi A. Aultman, # 54 Exhibit 54: Specifications for Preparing, # 55 Exhibit 55: Christiana A. Cirucci, # 56 Exhibit 56: Pam Belluck, # 57 Exhibit 57: 2019 REMS Single Shared, # 58 Exhibit 58: HHS, Marking, # 59 Exhibit 59: Press Release, HHS, HHS, # 60 Exhibit 60: White House, FACT SHEET, # 61 Exhibit 61: HHS, Secretarys Report, # 62 Exhibit 62: Abuzz, Abortion Pill Access, # 63 Exhibit 63: Abuzz, Need abortion care, # 64 Exhibit 64: A Safe Choice, Home, # 65 Exhibit 65: A Safe Choice, Online Consultation Form, # 66 Exhibit 66: Choices Rising, # 67 Exhibit 67: MAP, # 68 Exhibit 68: Scott Calvert, # 69 Exhibit 69: Rachel Roubein, # 70 Exhibit 70: Rebecca Grant, # 71 Exhibit 71: Aid Access, # 72 Exhibit 72: Elissa Nadworny, # 73 Exhibit 73: Abigail Brooks, # 74 Exhibit 74: Pam Belluck, # 75 Exhibit 75: Caroline Kitchener, Alone in a bathroom: The fear and uncertainty oft, # 76 Exhibit 76: Her Safe Harbor, Abortion Pills Online, # 77 Exhibit 77: Pam Belluck, A day with one abortion pill prescriber, N.Y. Times, # 78 Exhibit 78: Abuzz, FAQs, # 79 Exhibit 79: ACT, Who We Are, # 80 Exhibit 80: ACT, What We Do, # 81 Exhibit 81: ACT, FAQs, # 82 Exhibit 82: ACT, Resources, # 83 Exhibit 83: Alaa Elassar, # 84 Exhibit 84: Rosemary Westwood, # 85 Exhibit 85: Katherine Donlevy, # 86 Exhibit 86: Lorena ONeil, # 87 Exhibit 87: Press Release, ACT, # 88 Exhibit 88: Press Release, Protecting, # 89 Exhibit 89: Rosemary Westwood, # 90 Exhibit 90: Governor Kathy Hochul, # 91 Exhibit 91: Society of Family Planning, # 92 Exhibit 92: Rosalie Markezich, # 93 Exhibit 93: Exhibit 5: Medicaid, # 94 Exhibit 94: Julie ODonoghue, # 95 Exhibit 95: LDH Medicaid, # 96 Exhibit 96: Marc Roemer, # 97 Exhibit 97: Hospital Services Provider, # 98 Exhibit 98: Louisiana Medicaid Hospital Ambulatory, # 99 Exhibit 99: Louisiana Medicaid Hospital, # 100 Exhibit 100: Louisiana Medicaid Hospital Ambulatory Surgery Fee Schedule: Non-Rural, # 101 Exhibit 101: Medicaid Services, # 102 Exhibit 102: State Hospitals, # 103 Exhibit 103: Small Rural Hospital, # 104 Exhibit 104: Louisiana Medicaid Hospital Provider Inpatient Per Diem Rates, # 105 Exhibit 105: Pam Belluck, # 106 Exhibit 106: AP, Texas, # 107 Exhibit 107: Caroline Kitchner, # 108 Exhibit 108: Secretary Kennedy, # 109 Exhibit 109: Evita Solutions, # 110 Exhibit 110: Letter from Robert F. Kennedy, # 111 Civil cover sheet)(aty,Huettemann, Caitlin) Modified on 10/7/2025 to modify docket text. Crick, S). (Entered: 10/06/2025) 1 Exhibit 1: Society of Family Planning View on PACER 2 Exhibit 2: Society of Family Planning View on PACER 3 Exhibit 3: 2021 FDA Letter View on PACER 4 Exhibit 4: Dr. Margaret Carpenter indictment View on PACER 5 Exhibit 5: Center for Drug Evaluation & Research Application View on PACER 6 Exhibit 6: Mifepristone, StatPearls View on PACER 7 Exhibit 7: The Facts on Mifepristone View on PACER 8 Exhibit 8: Medication Abortion View on PACER 9 Exhibit 9: 2023 FDA-Approved Label View on PACER 10 Exhibit 10: 2021 FDA Letter to AAPLOG View on PACER 11 Exhibit 11: Center for Drug Evaluation & Research Application View on PACER 12 Exhibit 12: Comparison of rates View on PACER 13 Exhibit 13: Abortion Pill Harms Women View on PACER 14 Exhibit 14: Comparative Acuity View on PACER 15 Exhibit 15: Will a doctor be able to tell View on PACER 16 Exhibit 16: How do you know View on PACER 17 Exhibit 17: Am Coll of Obstetricians & Gynecologists Practice View on PACER 18 Exhibit 18: #AbortionChangesYou View on PACER 19 Exhibit 19: Population Council View on PACER 20 Exhibit 20: 2002 Citizen Petition View on PACER 21 Exhibit 21: Robert OHarrow Jr View on PACER 22 Exhibit 22: Hannah Levintova View on PACER 23 Exhibit 23: Letter from Center for Drug Evaluation View on PACER 24 Exhibit 24: 2000 FDA Approval Letter View on PACER 25 Exhibit 25: 2019 FDA ANDA Approval Letter View on PACER 26 Exhibit 26: FDA Center for Drug Evaluation View on PACER 27 Exhibit 27: 2000 FDA Approval Memo View on PACER 28 Exhibit 28: Identification of Drug & Biological Products View on PACER 29 Exhibit 29: 2011 FDA Supplemental Approval Letter View on PACER 30 Exhibit 30: 2011 REMS for NDA View on PACER 31 Exhibit 31: 2016 FDA Letter to AAPLOG View on PACER 32 Exhibit 32: 2020 Letter from ACOG View on PACER 33 Exhibit 33: Students for Life of America View on PACER 34 Exhibit 34: 2023 FDA Letter to Students View on PACER 35 Exhibit 35: 2021 FDA Center for Drug Evaluation View on PACER 36 Exhibit 36: Oral History Interview View on PACER 37 Exhibit 37: White House, Readout View on PACER 38 Exhibit 38: White House, Press Briefing View on PACER 39 Exhibit 39: Ian Millhiser View on PACER 40 Exhibit 40: White House, Remarks by President Biden Before View on PACER 41 Exhibit 41: White House, Remarks by President Biden View on PACER 42 Exhibit 42: White House, FACT SHEET View on PACER 43 Exhibit 43: White House, Remarks by President Biden View on PACER 44 Exhibit 44: Exec. Order No. 14076 View on PACER 45 Exhibit 45: Exec. Order No. 14079 View on PACER 46 Exhibit 46: Presidential Memorandum View on PACER 47 Exhibit 47: White House, FACT SHEET View on PACER 48 Exhibit 48: Press Release, HHS, HHS View on PACER 49 Exhibit 49: Press Release, HHS, View on PACER 50 Exhibit 50: Center for Drug Evaluation & Research, Application Number: 020687O View on PACER 51 Exhibit 51: Center for Drug Evaluation & Research, Application Numbers: 020687 View on PACER 52 Exhibit 52: FDA Adverse Events Reporting View on PACER 53 Exhibit 53: Kathi A. Aultman et al View on PACER 54 Exhibit 54: Specifications for Preparing View on PACER 55 Exhibit 55: Christiana A. Cirucci et al View on PACER 56 Exhibit 56: Pam Belluck View on PACER 57 Exhibit 57: 2019 REMS Single Shared View on PACER 58 Exhibit 58: HHS, Marking View on PACER 59 Exhibit 59: Press Release, HHS, HHS View on PACER 60 Exhibit 60: White House, FACT SHEET: View on PACER 61 Exhibit 61: HHS, Secretarys Report View on PACER 62 Exhibit 62: Abuzz, Abortion Pill Access View on PACER 63 Exhibit 63: Abuzz, Need abortion care View on PACER 64 Exhibit 64: A Safe Choice, Home View on PACER 65 Exhibit 65: A Safe Choice, Online Consultation Form View on PACER 66 Exhibit 66: Choices Rising View on PACER 67 Exhibit 67: MAP View on PACER 68 Exhibit 68: Scott Calvert View on PACER 69 Exhibit 69: Rachel Roubein View on PACER 70 Exhibit 70: Rebecca Grant View on PACER 71 Exhibit 71: Aid Access View on PACER 72 Exhibit 72: Elissa Nadworny View on PACER 73 Exhibit 73: Abigail Brooks View on PACER 74 Exhibit 74: Pam Belluck View on PACER 75 Exhibit 75: Caroline Kitchener, Alone in a bathroom: The fear and uncertainty of View on PACER 76 Exhibit 76: Her Safe Harbor, Abortion Pills Online View on PACER 77 Exhibit 77: Pam Belluck, A day with one abortion pill prescriber, N.Y. Times View on PACER 78 Exhibit 78: Abuzz, FAQs View on PACER 79 Exhibit 79: ACT, Who We Are View on PACER 80 Exhibit 80: ACT, What We Do View on PACER 81 Exhibit 81: ACT, FAQs View on PACER 82 Exhibit 82: ACT, Resources View on PACER 83 Exhibit 83: Alaa Elassar View on PACER 84 Exhibit 84: Rosemary Westwood View on PACER 85 Exhibit 85: Katherine Donlevy View on PACER 86 Exhibit 86: Lorena ONeil View on PACER 87 Exhibit 87: Press Release, ACT View on PACER 88 Exhibit 88: Press Release, Protecting View on PACER 89 Exhibit 89: Rosemary Westwood View on PACER 90 Exhibit 90: Governor Kathy Hochul View on PACER 91 Exhibit 91: Society of Family Planning View on PACER 92 Exhibit 92: Rosalie Markezich View on PACER 93 Exhibit 93: Exhibit 5: Medicaid View on PACER 94 Exhibit 94: Julie ODonoghue View on PACER 95 Exhibit 95: LDH Medicaid View on PACER 96 Exhibit 96: Marc Roemer View on PACER 97 Exhibit 97: Hospital Services Provider View on PACER 98 Exhibit 98: Louisiana Medicaid Hospital Ambulatory View on PACER 99 Exhibit 99: Louisiana Medicaid Hospital Ambulatory Surgery Fee Schedule: Rural H View on PACER 100 Exhibit 100: Louisiana Medicaid Hospital Ambulatory Surgery Fee Schedule: Non-Ru View on PACER 101 Exhibit 101: Medicaid Services View on PACER 102 Exhibit 102: State Hospitals View on PACER 103 Exhibit 103: Small Rural Hospital View on PACER 104 Exhibit 104: Louisiana Medicaid Hospital Provider Inpatient Per Diem Rates View on PACER 105 Exhibit 105: Pam Belluck View on PACER 106 Exhibit 106: AP, Texas View on PACER 107 Exhibit 107: Caroline Kitchner View on PACER 108 Exhibit 108: Secretary Kennedy View on PACER 109 Exhibit 109: Evita Solutions View on PACER 110 Exhibit 110: Letter from Robert F. Kennedy View on PACER 111 Civil cover sheet View on PACER	Oct. 6, 2025	Oct. 6, 2025 Clearinghouse
	Case Assigned/Reassigned	Oct. 6, 2025	Oct. 6, 2025
	CASE Assigned to Judge David C Joseph and Magistrate Judge David J Ayo. (crt,Crick, S)	Oct. 6, 2025	Oct. 6, 2025
2	SUMMONS ISSUED as to U S Attorney, U S Attorney General, U S Food & Drug Administration, Martin Makary, George Francis Tidmarsh, U S Dept of Health & Human Services, Robert F Kennedy, Jr. (crt,Crick, S) (Entered: 10/07/2025)	Oct. 7, 2025	Oct. 7, 2025
	Case Assigned/Reassigned	Oct. 7, 2025	Oct. 7, 2025
3	SUMMONS ISSUED as to U S Attorney, U S Attorney General, Robert F Kennedy Jr. (crt,Crick, S) (Entered: 10/09/2025)	Oct. 9, 2025	Oct. 9, 2025
4	MOTION for Erik C. Baptist to Appear Pro Hac Vice (Admission fee: $105, receipt number ALAWDC-6420762) by State Louisiana, Rosalie Markezich. Motions referred to David J Ayo. Motion Ripe Deadline set for 10/9/2025. (Attachments: # 1 Proposed order)(aty,Huettemann, Caitlin) (Entered: 10/09/2025)	Oct. 9, 2025	Oct. 9, 2025
5	MOTION for Erin M. Hawley to Appear Pro Hac Vice (Admission fee: $105, receipt number ALAWDC-6421078) by All Plaintiffs. Motions referred to David J Ayo. Motion Ripe Deadline set for 10/9/2025. (Attachments: # 1 Proposed order)(aty,Huettemann, Caitlin) (Entered: 10/09/2025)	Oct. 9, 2025	Oct. 9, 2025
6	MOTION for Julie Marie Blake to Appear Pro Hac Vice (Admission fee: $105, receipt number ALAWDC-6421086) by All Plaintiffs. Motions referred to David J Ayo. Motion Ripe Deadline set for 10/9/2025. (Attachments: # 1 Proposed order)(aty,Huettemann, Caitlin) (Entered: 10/09/2025)	Oct. 9, 2025	Oct. 9, 2025
7	MOTION for Frank W. Basgall to Appear Pro Hac Vice (Admission fee: $105, receipt number ALAWDC-6421099) by All Plaintiffs. Motions referred to David J Ayo. Motion Ripe Deadline set for 10/9/2025. (Attachments: # 1 Proposed order)(aty,Huettemann, Caitlin) (Entered: 10/09/2025)	Oct. 9, 2025	Oct. 9, 2025
8	MOTION for Gabriella M. McIntyre to Appear Pro Hac Vice (Admission fee: $105, receipt number ALAWDC-6421103) by All Plaintiffs. Motions referred to David J Ayo. Motion Ripe Deadline set for 10/9/2025. (Attachments: # 1 Proposed order)(aty,Huettemann, Caitlin) (Entered: 10/09/2025)	Oct. 9, 2025	Oct. 9, 2025
9	MOTION for Dalton A. Nichols to Appear Pro Hac Vice (Admission fee: $105, receipt number ALAWDC-6421116) by All Plaintiffs. Motions referred to David J Ayo. Motion Ripe Deadline set for 10/9/2025. (Attachments: # 1 Proposed order)(aty,Huettemann, Caitlin) (Entered: 10/09/2025)	Oct. 9, 2025	Oct. 9, 2025
10	ORDER granting 4 Motion to Appear Pro Hac Vice for appearance of Erik C Baptist for State Louisiana, Rosalie Markezich. Signed by Magistrate Judge David J Ayo on 10/10/2025. (crt,Crick, S) (Entered: 10/10/2025)	Oct. 10, 2025	Oct. 10, 2025
11	ORDER granting 6 Motion to Appear Pro Hac Vice for appearance of Julie Marie Blake for State Louisiana, Rosalie Markezich. Signed by Magistrate Judge David J Ayo on 10/10/2025. (crt,Crick, S) (Entered: 10/10/2025)	Oct. 10, 2025	Oct. 10, 2025
12	ORDER granting 5 Motion to Appear Pro Hac Vice for appearance of Erin M Hawley for State Louisiana, Rosalie Markezich. Signed by Magistrate Judge David J Ayo on 10/10/2025. (crt,Crick, S) (Entered: 10/10/2025)	Oct. 10, 2025	Oct. 10, 2025
13	ORDER granting 7 Motion to Appear Pro Hac Vice for appearance of Frank W Basgall for State Louisiana, Rosalie Markezich. Signed by Magistrate Judge David J Ayo on 10/10/2025. (crt,Crick, S) (Entered: 10/10/2025)	Oct. 10, 2025	Oct. 10, 2025
14	ORDER granting 8 Motion to Appear Pro Hac Vice for appearance of Gabriella M McIntyre for State Louisiana, Rosalie Markezich. Signed by Magistrate Judge David J Ayo on 10/10/2025. (crt,Crick, S) (Entered: 10/10/2025)	Oct. 10, 2025	Oct. 10, 2025
15	ORDER granting 9 Motion to Appear Pro Hac Vice for appearance of Dalton A Nichols for State Louisiana, Rosalie Markezich. Signed by Magistrate Judge David J Ayo on 10/10/2025. (crt,Crick, S) (Entered: 10/10/2025)	Oct. 10, 2025	Oct. 10, 2025
16	SUMMONS Returned Executed by State Louisiana U S Food & Drug Administration served on 10/15/2025, answer due 12/15/2025; U S Dept of Health & Human Services served on 10/22/2025, answer due 12/22/2025; Robert F Kennedy, Jr served on 10/15/2025, answer due 12/15/2025; Martin Makary served on 10/15/2025, answer due 12/15/2025; George Francis Tidmarsh served on 10/22/2025, answer due 12/22/2025. (aty,Huettemann, Caitlin) Modified on 11/5/2025 to modify dates of service and answer due dates. (Crick, S). (Entered: 11/05/2025)	Nov. 5, 2025	Nov. 5, 2025
	Notice of Corrective Action	Nov. 5, 2025	Nov. 5, 2025
	NOTICE of Corrective Action to Caitlin Ann Huettemann on behalf of State Louisiana regarding 16 Summons Returned Executed as to USA,,. Action taken: Docket text modified to reflect correct service date of 10/15/25 and answer due date of 12/15/25 as to U S Food & Drug Administration, Robert F Kennedy, Jr & Martin Makary as an incorrect service date was entered at the time of e-filing. (crt,Crick, S)	Nov. 5, 2025	Nov. 5, 2025
17	NOTICE of Appearance by Noah T Katzen on behalf of U S Food & Drug Administration, U S Dept of Health & Human Services, Robert F Kennedy, Jr, Martin Makary, George Francis Tidmarsh (Attorney Noah T Katzen added to party U S Food & Drug Administration(pty:dft), U S Dept of Health & Human Services(pty:dft), Robert F Kennedy, Jr(pty:dft), Martin Makary(pty:dft), George Francis Tidmarsh(pty:dft)) (aty,Katzen, Noah) Modified on 11/26/2025 to modify docket text. (Crick, S). (Entered: 11/26/2025)	Nov. 26, 2025	Nov. 26, 2025
18	Consent MOTION for Extension of Time to File Answer with consent by All Defendants. Motions referred to David J Ayo. Motion Ripe Deadline set for 11/26/2025. (Attachments: # 1 Text of proposed order)(aty,Katzen, Noah) (Entered: 11/26/2025)	Nov. 26, 2025	Nov. 26, 2025
19	ORDER granting 18 Motion for Extension of Time to Answer re 1 Complaint. U S Food & Drug Administration, U S Dept of Health & Human Services, Robert F Kennedy, Jr, Martin Makary, and George Francis Tidmarsh answer due 1/12/2026. Signed by Magistrate Judge David J Ayo on 12/1/2025. (crt,Chicola, C) (Entered: 12/01/2025)	Dec. 1, 2025	Dec. 1, 2025 RECAP
20	MOTION for Preliminary Injunction, or MOTION for Preliminary Relief Under 5 U.S.C. § 705by All Plaintiffs. Motion Ripe Deadline set for 12/17/2025. (Attachments: # 1 Exhibit 1 #WeCount Report April 2022 to June 2025 (Dec. 9, 2025), # 2 Exhibit 2 #WeCount Report Summary Slides with National and 51 State-Level Findings April 2022 to June 2025 (Dec. 9, 2025), # 3 Exhibit 3 Abigail R. A. Aiken et al., Research Letter, Provision of Abortion Medications Using Online Asynchronous Telemedicine Under Shield Laws in the US, 334(15) JAMA 1388 (Oct. 21, 2025), # 4 Exhibit 4 Robin Wallace et al, P040 - Expanding Access to Abortion with Mifepristone and Misoprostol Through 84 Days Estimated Gestational Duration, 151 Contraception 111117 (Nov. 2025), # 5 Exhibit 5 Governor Newsom Signs New Landmark Laws to Protect Reproductive Freedom, Patient Privacy Amid Trumps War on Women, Gov. Gavin Newsom (Sep. 26, 2025), # 6 Exhibit 6 US FDA Has Delayed Abortion Pill Safety Study, Bloomberg News Reports, Reuters (Dec. 8, 2025, at 14:23 PT), # 7 Exhibit 7 Elizabeth Troutman Mitchell, EXCLUSIVE: Makary Responds to Report Saying He Slow-Walked Abortion Pill Safety Review, Daily Signal (Dec. 9, 2025), # 8 Exhibit 8 Ian Lopez, RFK Jr. Says Biden Twisted the Data on Abortion Pill Safety, BL (Sep. 4, 2025, at 12:45 ET), # 9 Exhibit 9 U.S. Senator Bill Cassidy, M.D. (@SenBillCassidy), X (Dec. 12, 2025, at 13:05 PT), # 10 Exhibit 10 Video posted by Elizabeth Mitchell Troutman (@TheElizMitchell), X, at 02:022:19 (Dec. 9, 2025, at 14:56 PT), # 11 Exhibit 11 T. Elliot Gaiser et al., The Truth of Erasure: Universal Remedies for Universal Agency Actions, U. Chi. L. Rev. Online (Aug. 28, 2024), # 12 Exhibit 12 Letter from Elizabeth Warren et al. to FDA (Nov. 18, 2022), # 13 Exhibit 13 Aria Bendix, Why Abortions Rose After Roe Was Overturned, NBC News (Nov. 26, 2024, at 2:00 PT), # 14 Exhibit 14 Complaint, Rodriguez v. Coeytaux, No. 3:25-cv-00225, (S.D. Tex. July 20, 2025), # 15 Exhibit 15 Notice of Cease and Desist from Ken Paxton, Atty Gen. of Tex., to Remy Coeytaux (Aug. 14, 2025), # 16 Exhibit 16 FDA, REMS Single Shared System for Mifepristone 200MG (May 2021), # 17 Exhibit 17 REMS Compliance Program, FDA (Sep. 22, 2022), # 18 Exhibit 18 Declaration of John Voltz, M.D. (Nov. 17, 2025), # 19 Exhibit 19 Declaration of Kathleen Richard, LMSW (Nov. 12, 2025), # 20 Exhibit 20 Declaration of Kathleen Willis, M.D. (Dec. 15, 2025), # 21 Exhibit 21 Declaration of Christina Francis, M.D. (Dec. 12, 2025), # 22 Exhibit 22 Declaration of Michael J. New, Ph.D (Dec. 15, 2025), # 23 Exhibit 23 Declaration of Angela Parise, M.D. (Dec. 11, 2025), # 24 Exhibit 24 Declaration of Lindsey Sikes (Dec. 15, 2025), # 25 Exhibit 25 Declaration of Gabriella McIntyre (Dec. 16, 2025), # 26 Memorandum / Brief in Support of Plaintiff State of Louisiana and Rosalie Markzich's Motion for Preliminary Injunction for Preliminary Relief Under 5 U.S.C. § 705, # 27 Exhibit List, # 28 Proposed order Granting Plaintiff State of Louisiana and Rosalie Markzich's Motion for Preliminary Injunction for Preliminary Relief Under 5 U.S.C. § 705)(aty,Huettemann, Caitlin). Added MOTION for Preliminary Relief and modified docket text on 12/17/2025 (Crick, S). (Entered: 12/17/2025) 1 Exhibit 1 #WeCount Report April 2022 to June 2025 (Dec. 9, 2025) View on PACER 2 Exhibit 2 #WeCount Report Summary Slides with National and 51 State-Level View on PACER 3 Exhibit 3 Abigail R. A. Aiken et al., Research Letter, Provision of Abortion Me View on PACER 4 Exhibit 4 Robin Wallace et al, P040 - Expanding Access to Abortion with Mifepri View on PACER 5 Exhibit 5 Governor Newsom Signs New Landmark Laws to Protect Reproductive Freed View on PACER 6 Exhibit 6 US FDA Has Delayed Abortion Pill Safety Study, Bloomberg News Reports View on PACER 7 Exhibit 7 Elizabeth Troutman Mitchell, EXCLUSIVE: Makary Responds to Report Say View on PACER 8 Exhibit 8 Ian Lopez, RFK Jr. Says Biden Twisted the Data on Abortion Pill Safet View on PACER 9 Exhibit 9 U.S. Senator Bill Cassidy, M.D. (@SenBillCassidy), X (Dec. 12, 2 View on RECAP 10 Exhibit 10 Video posted by Elizabeth Mitchell Troutman (@TheElizMitchell), View on PACER 11 Exhibit 11 T. Elliot Gaiser et al., The Truth of Erasure: Universal Remedies fo View on RECAP 12 Exhibit 12 Letter from Elizabeth Warren et al. to FDA (Nov. 18, 2022) View on PACER 13 Exhibit 13 Aria Bendix, Why Abortions Rose After Roe Was Overturned, NBC News ( View on PACER 14 Exhibit 14 Complaint, Rodriguez v. Coeytaux, No. 3:25-cv-00225, (S.D. Tex. July View on PACER 15 Exhibit 15 Notice of Cease and Desist from Ken Paxton, Atty Gen. of Tex., to Re View on PACER 16 Exhibit 16 FDA, REMS Single Shared System for Mifepristone 200MG (May 2021) View on PACER 17 Exhibit 17 REMS Compliance Program, FDA (Sep. 22, 2022) View on PACER 18 Exhibit 18 Declaration of John Voltz, M.D. (Nov. 17, 2025) View on PACER 19 Exhibit 19 Declaration of Kathleen Richard, LMSW (Nov. 12, 2025) View on PACER 20 Exhibit 20 Declaration of Kathleen Willis, M.D. (Dec. 15, 2025) View on PACER 21 Exhibit 21 Declaration of Christina Francis, M.D. (Dec. 12, 2025) View on PACER 22 Exhibit 22 Declaration of Michael J. New, Ph.D (Dec. 15, 2025) View on PACER 23 Exhibit 23 Declaration of Angela Parise, M.D. (Dec. 11, 2025) View on PACER 24 Exhibit 24 Declaration of Lindsey Sikes (Dec. 15, 2025) View on PACER 25 Exhibit 25 Declaration of Gabriella McIntyre (Dec. 16, 2025) View on PACER 26 Memorandum / Brief in Support of Plaintiff State of Louisiana & Rosalie Markzich View on RECAP 27 Exhibit List View on PACER 28 Proposed order Granting Plaintiff State of Louisiana & rosalie Markzich's M View on PACER	Dec. 17, 2025	Dec. 17, 2025 RECAP
21	ELECTRONIC MINUTE ENTRY: A Zoom Status Conference to determine briefing deadlines re MOTION for Preliminary Injunction, or MOTION for Preliminary Relief Under 5 U.S.C. § 705 filed by all Plaintiffs is set for Friday, 12/19/2025 at 9:30 AM via Zoom Video Conference before Judge David C Joseph. A Zoom link will be forwarded via email to all counsel of record. Signed by Judge David C Joseph on 12/17/2025. (crt,LaCombe, L) (Entered: 12/17/2025)	Dec. 17, 2025	Dec. 17, 2025
	Set Motion and R&R Deadlines/Hearings	Dec. 17, 2025	Dec. 17, 2025
	Minute Entry AND ~Util - Set Hearings	Dec. 17, 2025	Dec. 17, 2025
	Set/Reset Deadlines as to 20 MOTION for Preliminary Injunction or for Preliminary Relief Under 5 U.S.C. § 705. Motion Ripe Deadline set for 12/17/2025. (crt,Crick, S)	Dec. 17, 2025	Dec. 17, 2025
22	MOTION for J. Benjamin Aguiaga to Appear Pro Hac Vice (Admission fee: $105, receipt number ALAWDC-6509312) by State Louisiana. Motions referred to David J Ayo. Motion Ripe Deadline set for 12/18/2025. (Attachments: # 1 Certificate of good standing, # 2 Proposed Order)(aty,Huettemann, Caitlin) Modified on 12/18/2025 to modify filer.(Crick, S). (Entered: 12/18/2025)	Dec. 18, 2025	Dec. 18, 2025
23	MOTION to Participate in Status Conference & NOTICE of Intent to Move to Intervene by Danco Laboratories L L C (Attorney William Brock Most added to party Danco Laboratories L L C(pty:intv)) (aty,Most, William) Modified on 12/18/2025 to capture motion event. (Crick, S). (Entered: 12/18/2025)	Dec. 18, 2025	Dec. 18, 2025 RECAP
24	Ex Parte MOTION for Jessica L. Ellsworth to Appear Pro Hac Vice (Admission fee: $105, receipt number ALAWDC-6509765) by Danco Laboratories, LLC. Motions referred to David J Ayo. Motion Ripe Deadline set for 12/18/2025. (Attachments: # 1 Exhibit A (Certificate of Good Standing), # 2 Proposed order)(aty,Most, William) (Entered: 12/18/2025) 1 Exhibit A (Certificate of Good Standing) View on RECAP 2 Proposed order View on RECAP	Dec. 18, 2025	Dec. 18, 2025 RECAP
25	Proposed Briefing Schedule by State Louisiana, Rosalie Markezich re 21 Minute Entry,, Set Hearings, . (aty,Huettemann, Caitlin) Modified on 12/18/2025 to modify docket text. (Crick, S). (Entered: 12/18/2025)	Dec. 18, 2025	Dec. 18, 2025 RECAP
26	MOTION to Participate in Status Conference & NOTICE to Intervene by GenBioPro (Attorney John N Adcock added to party GenBioPro(pty:intvd)) (aty,Adcock, John) Modified on 12/19/2025 to capture motion event and modify docket text. (Crick, S). (Entered: 12/18/2025)	Dec. 18, 2025	Dec. 18, 2025 RECAP
27	Ex Parte MOTION for Robert Katerberg to Appear Pro Hac Vice (Admission fee: $105, receipt number ALAWDC-6510616) by GenBioPro. Motions referred to David J Ayo. Motion Ripe Deadline set for 12/18/2025. (Attachments: # 1 Certificate of good standing)(aty,Adcock, John) Modified on 12/19/2025 to indicate proposed order included within PDF of main document. (Crick, S). (Entered: 12/18/2025)	Dec. 18, 2025	Dec. 18, 2025
	Set Motion and R&R Deadlines/Hearings	Dec. 18, 2025	Dec. 18, 2025
	Motions Transferred	Dec. 18, 2025	Dec. 18, 2025
	Set/Reset Deadlines as to 23 MOTION to Participate in Status Conference. Motion Ripe Deadline set for 12/18/2025. (crt,Crick, S)	Dec. 18, 2025	Dec. 18, 2025
	Motions Transferred regarding 26 MOTION to Participate in Status Conference & Notice of Intent to Intervene. Motions referred to Magistrate Judge David J Ayo. (crt,Crick, S)	Dec. 18, 2025	Dec. 18, 2025
	Motions Transferred regarding 26 MOTION to Participate in Status Conference & Notice of Intent to Intervene. Motions referred to Judge David C Joseph. (crt,Crick, S)	Dec. 18, 2025	Dec. 18, 2025
28	MINUTES for proceedings held before Judge David C Joseph: STATUS CONFERENCE held on 12/19/2025. Danco Laboratories LLC's Motion to Participate in Status Conference 23 is GRANTED. GenBioPro's Motion to Participate in Status Conference 26 is DENIED as late-filed. After discussion with the parties, the following briefing scheduling is ORDERED: The Government's response to the Motion for Preliminary Injunction, along with the Government's Answer and any Rule 12 motion, shall be filed no later than January 23, 2026. All motions to intervene and any conditional responses to the Motion for Preliminary Injunction by the proposed intervenors shall be filed no later than January 30, 2026. Plaintiffs Reply to the Defendants response to the Preliminary Injunction Motion, as well as any response to any motion filed by Defendants and any responses by Plaintiffs or Defendants to any motions to intervene and conditional responses of the intervenors to the Preliminary Injunction Motion shall be filed no later than February 13, 2025. The Defendants' Reply in support of any Rule 12 or other motion shall be filed no later than February 20, 2026. A hearing is set for February 24, 2026, at 10:00 am in Courtroom 1, Lafayette, before Judge David Joseph regarding the Motion for Preliminary Injunction 20 . (Court Reporter: VTC) (crt,Craig, C) (Entered: 12/19/2025)	Dec. 19, 2025	Dec. 19, 2025 RECAP
29	MOTION for Substitution of Lead Attorney by Rosalie Markezich. Motions referred to David J Ayo. Motion Ripe Deadline set for 12/19/2025. (Attachments: # 1 Proposed order)(aty,Baptist, Erik) (Entered: 12/19/2025) 1 Proposed order View on PACER	Dec. 19, 2025	Dec. 19, 2025 RECAP
	Motions Transferred	Dec. 19, 2025	Dec. 19, 2025
	Set Motion and R&R Deadlines/Hearings	Dec. 19, 2025	Dec. 19, 2025
	Set/Reset Deadlines as to 20 MOTION for Preliminary Injunction or for Preliminary Relief Under 5 U.S.C. § 705 MOTION for Preliminary Relief Under 5 USC 705. Motion day set for 2/24/2026 10:00 AM in Lafayette, Courtroom 1 before Judge David C Joseph. (crt,Craig, C)	Dec. 19, 2025	Dec. 19, 2025
30	ORDER granting 22 Motion to Appear Pro Hac Vice for appearance of J Benjamin Aguinaga for State Louisiana,J Benjamin Aguinaga for Rosalie Markezich. Signed by Magistrate Judge David J Ayo on 12/19/2025. (crt,Bunting, M) (Entered: 12/22/2025)	Dec. 22, 2025	Dec. 22, 2025
31	ORDER granting 24 Motion to Appear Pro Hac Vice for appearance of Jessica L Ellsworth for Danco Laboratories L L C. Signed by Magistrate Judge David J Ayo on 12/19/2025. (crt,Bunting, M) (Entered: 12/22/2025)	Dec. 22, 2025	Dec. 22, 2025
32	ORDER granting 27 Motion to Appear Pro Hac Vice for appearance of Robert J Katerberg for GenBioPro Inc. Signed by Magistrate Judge David J Ayo on 12/19/2025. (crt,Bunting, M) (Entered: 12/22/2025)	Dec. 22, 2025	Dec. 22, 2025
33	ORDER granting 29 Motion Substitution of Lead Attorney. Erik C. Baptist is now Lead Attorney for Rosalie Markezich. Signed by Magistrate Judge David J Ayo on 12/23/2025. (crt,Bunting, M) (Entered: 12/23/2025)	Dec. 23, 2025	Dec. 23, 2025 RECAP
34	Miscellaneous Relief	Jan. 16, 2026	Jan. 16, 2026