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

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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.

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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

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Documents in the Clearinghouse

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

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Docket

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

Last updated Oct. 31, 2025, 8:43 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 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 PACER
	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 PACER
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 PACER
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 PACER
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 PACER
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 PACER
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 PACER
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 PACER
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 PACER
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 PACER
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 PACER
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 PACER
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 PACER
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 PACER