Case: Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration

2:22-cv-00223 | U.S. District Court for the Northern District of Texas

Filed Date: Nov. 18, 2022

Case Ongoing

Clearinghouse coding complete

Case Summary

On November 18, 2022, four national medical associations and four doctors with alleged experience in caring for pregnant and post-abortive patients sued the United States Food & Drug Administration (FDA), seeking to overturn the agency’s decades-old authorization of mifepristone, a pill that induces abortions. Represented by Alliance Defending Freedom and a private law firm, Plaintiffs brought suit in the United States District Court for the Northern District of Texas. Plaintiffs brought suit u…

On November 18, 2022, four national medical associations and four doctors with alleged experience in caring for pregnant and post-abortive patients sued the United States Food & Drug Administration (FDA), seeking to overturn the agency’s decades-old authorization of mifepristone, a pill that induces abortions. Represented by Alliance Defending Freedom and a private law firm, Plaintiffs brought suit in the United States District Court for the Northern District of Texas. Plaintiffs brought suit under the Administrative Procedure Act (APA), arguing that the FDA's approval and subsequent regulation of medication abortion was in excess of the agency's jurisdiction as well as arbitrary and capricious. Plaintiffs sought injunctive and declaratory relief in addition to attorneys' fees. In particular, Plaintiffs requested that the Court order Defendants to withdraw mifepristone as an FDA-approved chemical abortion drug. The case was assigned to Judge Matthew Joseph Kacsmaryk.

The day the case was filed, Plaintiffs filed a motion for a preliminary injunction. Several amicus briefs were submitted on both sides, including briefs by members of Congress and states. On January 13, 2023, Danco Laboratories - the holder of the FDA new drug application approval for mifepristone - moved to intervene as a defendant. On February 6, 2023, the Court granted the motion. Briefing by the parties was completed on February 24, 2023, and on March 15, the Court held a hearing on the matter. 

On April 7, 2023, Judge Kacsmaryk granted the Plaintiffs' motion in part. First resolving all procedural issues, he concluded that the medical association plaintiffs had associational and organizational standing and that they alleged concrete and redressable injuries in the form of "intense side effects and significant complications for their patients requiring medical intervention and attention." The Court also determined that the claims were reviewable, because even though FDA approved mifepristone in 2000, it "reopened" its decision in 2016 and 2021 by changing the mifepristone regulatory scheme. Because the Court held that the agency's decisions were not committed to agency discretion and the Plaintiffs' failure to exhaust certain claims was excusable, the Court had jurisdiction.

Turning to the merits, the Court held, in the April 7, 2023 decision, that the Plaintiffs' challenges had a substantial likelihood of success, that there was a substantial threat of irreparable harm, and that preliminary relief would serve the public interest. On the first prong of analysis, Judge Kacsmaryk held that the FDA's actions likely violated the Comstock Act, which prohibits the mailing of articles, instruments, substances, drugs, and medicines for abortion. He also held that the actions were likely arbitrary and capricious in violation of the APA, critiquing the FDA's approval process and subsequent regulatory changes.

As for relief, Judge Kacsmaryk held that a stay under Section 705 of the APA would be more appropriate than ordering withdrawal or suspension of FDA's approval. He therefore stayed the effective date of FDA's approval of mifepristone and all subsequent challenged actions relating to that approval. Included in his decision was a stay of seven days to allow the federal government to seek emergency relief from the United States Court of Appeals for the Fifth Circuit. Within hours of the decision being publicized, the FDA did indeed file an appeal with the Fifth Circuit as did Danco.

On the same day that Judge Kacsmaryk issued his decision, a District Court judge in Washington issued a decision in Washington v. FDA, preliminarily enjoining the FDA from altering the status quo and rights as it related to the availability of mifepristone under the current operative regulatory scheme in the seventeen plaintiff states plus the District of Columbia.

On April 12, 2023, the Fifth Circuit granted in part the defendants' motion for a stay pending appeal. The three-judge panel all agreed that the federal statute of limitations likely barred Judge Kacsmaryk’s ruling regarding the FDA’s original 2000 approval of mifepristone. Two of the judges went on to subsequently deny the motion to stay with respect to the rest of the lower ruling. In effect, this meant that mifepristone was still approved as it was in 2000, but with outdated restrictions and requirements that would substantially limit access. Importantly, the Fifth Circuit's holding endorsed the District Court's conclusions that the plaintiffs had standing and that the defendants were not irreparably harmed by the order. The Fifth Circuit also expedited the appeal to the next available oral argument calendar.

Two days after the Fifth Circuit's decision, on April 14, 2023, the Department of Justice and Danco both requested emergency relief from the Supreme Court of the United States, asking for a stay of the preliminary injunction pending appeal. Without emergency relief, the Fifth Circuit's order would have gone into effect that day at midnight. On April 14, Justice Alito announced that the order was administratively stayed until 11:59pm EDT on April 19, 2023, presumably to give the Court time to consider the request. On April 19, the Court extended the administrative stay for two more days.

On April 21, 2023, the United States Supreme Court granted the applications for stays requested by the FDA and Danco. The Court stayed Judge Kacsmaryk's decision pending disposition of the appeal in the United States Court of Appeals for the Fifth Circuit and disposition of a petition for a writ of certiorari, if such a writ is timely sought. Justice Thomas noted that he would have denied the applications, and Justice Alito authored a dissent. 

Litigation in the district court was stayed until the resolution of all appellate avenues concerning the April 7, 2023 order. The Fifth Circuit heard oral argument for May 17, 2023, and on August 16, the Fifth Circuit released its decision. It concluded that given the statute of limitations, the plaintiffs were unlikely to succeed on their challenge of the drug's original approval. The court also found that there was no evidence tending to show that the FDA's approval of the generic version of the drug contributed to the risk of harm. However, the court held that FDA's 2016 Amendments to the restrictions on the drug and the FDA's subsequent decision to allow the drug to be dispensed via mail were likely arbitrary and capricious. Because of the Supreme Court's April stay, the Fifth Circuit's August decision did not immediately go into effect. If it were to go into effect, mifepristone would remain on the market, but with additional restrictions limiting access. 

On September 8, 2023, both FDA and Danco filed petitions for a writ of certiorari with the Supreme Court. On December 13, 2023, the Supreme Court granted cert in both cases, consolidating the oral argument. Until the Supreme Court issues its opinion, access to mifepristone remains unchanged. The case is ongoing.

Summary Authors

Michelle Wolk (12/13/2023)

Related Cases

Washington v. United States Food and Drug Administration, Eastern District of Washington (2023)

People

For PACER's information on parties and their attorneys, see: https://www.courtlistener.com/docket/65768749/parties/alliance-for-hippocratic-medicine-v-us-food-and-drug-administration/


Judge(s)
Attorney for Plaintiff
Attorney for Defendant
Expert/Monitor/Master/Other

Aden, Steven H.

Amunson, Jessica Ring

Attorney, Michael Francis

Attorney, Jordan Dentler

Attorney, Delia Scoville,

Judge(s)

Kacsmaryk, Matthew Joseph (Texas)

Expert/Monitor/Master/Other

Aden, Steven H.

Amunson, Jessica Ring

Attorney, Michael Francis

Attorney, Jordan Dentler

Attorney, Delia Scoville,

Attorney, Charles William

Attorney, David Ray

Aukland-Peck, Adam Bresler (Texas)

Avoy, Janice Mac

Baigent, Charlotte

Beane, Amanda

Bendor, Joshua (Texas)

Bershteyn, Boris

Biggs, Richard (Texas)

Braiterman, Beth E (Texas)

Bustos, Fernando M (Texas)

Charles, Elizabeth A.

Chinn, Anthony Scott

Clayton, Ben E.

Clayton, Joshua Paul

Cordova, Alysia Brianna (Texas)

Counsel, John Marc

Counsel, Hugh Carleton

Dearing, Richard

Diaz, Mario (Texas)

Divine, Joshua (Texas)

Dotzel, Margaret

Elwood, John Patrick

Esposito, Denise (Texas)

Esq., Catherine Emily

Esq., Thomas S.

Esq., Shannon Rose

Esq., Robert Allen

Esq., Beth S.

Esq., Justin Lee

Fillmore, Charles W (Texas)

Fillmore, H Dustin (Texas)

Gannam, Roger K.

Gerry, Emily

Graves, Elissa Michelle (Texas)

Grossman, Lewis A (Texas)

Gutwein, Stephanie L.

Hacker, Heather Gebelin

Howard, Alyssa

Jennings, Michael S (Texas)

Jonat, Jayme Alyse

Jr, Robert A (Texas)

Julian, Guillaume (Texas)

Katerberg, Robert J.

Katz, Emile (Texas)

Klasing, Murphy S (Texas)

Leatherbury, Thomas S (Texas)

Lepiscopo, Peter Dominick

Liberto, Meredith Di (Texas)

Matheny, Justin Lee (Texas)

McCarty, Darren L (Texas)

McDonnell, Carolyn (Texas)

McGuiggan, Megan (Texas)

Meegan, Molly A (Texas)

Mezzina, Paul Alessio

Morten, Christopher (Texas)

Murdukhayeva, Ester

Neil, Rachel

Norred, Warren

Parker, Allan Edward

Post, Julia F (Texas)

Proper, Rona

Rosenthal, Joshua

Sansone, Nicolas

Sauer, Dean John

Schaerr, Gene C (Texas)

Schaffer, Darald John (Texas)

Schifini, Eva Marie

Schlafly, Andrew Layton

Schultz, William B.

Selden, Shannon Rose (Texas)

Sherwin, Galen (Texas)

Sherwood, Matthew W (Texas)

Smith, Michael F (Texas)

Solicitor, Joshua M.

Spital, Samuel

Squiers, Cristina Martinez (Texas)

Steffensen, Peter Blackmer (Texas)

Stempel, Danielle Desaulniers

Strauss, Simona

Sullivan, John Clay (Texas)

Temkin, Eva

Walsh, John F.

Wheat, John Marc (Texas)

Whelan, M Edward (Texas)

White, Edward Lawrence (Texas)

Winson, Robert John (Texas)

Zhou, Grace

Zieve, Allison M.

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Documents in the Clearinghouse

Document
1

2:22-cv-00223

Complaint

Nov. 18, 2022

Nov. 18, 2022

Complaint
137

2:22-cv-00223

Memorandum Opinion and Order

April 7, 2023

April 7, 2023

Order/Opinion

2023 U.S.Dist.LEXIS 2023

141

2:22-cv-00223

23-10362

Unpublished Order

U.S. Court of Appeals for the Fifth Circuit

April 12, 2023

April 12, 2023

Order/Opinion

00901

00902

Order Granting Stay

Supreme Court of the United States

April 21, 2023

April 21, 2023

Order/Opinion

2023 WL 2023

23-10362

Order

U.S. Court of Appeals for the Fifth Circuit

Aug. 16, 2023

Aug. 16, 2023

Order/Opinion

78 F.4th 78

Resources

Docket

See docket on RECAP: https://www.courtlistener.com/docket/65768749/alliance-for-hippocratic-medicine-v-us-food-and-drug-administration/

Last updated March 9, 2024, 3:08 a.m.

ECF Number Description Date Link Date / Link
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COMPLAINT against Xavier Becerra, Robert M. Califf, MD, Patrizia Cavazzoni, MD, U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Janet Woodcock, MD filed by George Delgado, MD, Regina Frost-Clark, MD, American College of Pediatricians, American Association of Pro-Life Obstetricians & Gynecologists, Christian Medical & Dental Associations, Alliance for Hippocratic Medicine, Tyler Johnson, DO, Shaun Jester, DO. (Filing fee $402; Receipt number ATXNDC-13312692) Plaintiff will submit summons(es) for issuance. In each Notice of Electronic Filing, the judge assignment is indicated, and a link to the Judges Copy Requirements and Judge Specific Requirements is provided. The court reminds the filer that any required copy of this and future documents must be delivered to the judge, in the manner prescribed, within three business days of filing. Unless exempted, attorneys who are not admitted to practice in the Northern District of Texas must seek admission promptly. Forms, instructions, and exemption information may be found at www.txnd.uscourts.gov, or by clicking here: Attorney Information - Bar Membership. If admission requirements are not satisfied within 21 days, the clerk will notify the presiding judge. (Attachments: # 1 Table of Exhibits, # 2 Exhibit(s) 1, # 3 Exhibit(s) 2, # 4 Exhibit(s) 3, # 5 Exhibit(s) 4, # 6 Exhibit(s) 5, # 7 Exhibit(s) 6, # 8 Exhibit(s) 7, # 9 Exhibit(s) 8, # 10 Exhibit(s) 9, # 11 Exhibit(s) 10, # 12 Exhibit(s) 11, # 13 Exhibit(s) 12, # 14 Exhibit(s) 13, # 15 Exhibit(s) 14, # 16 Exhibit(s) 15, # 17 Exhibit(s) 16, # 18 Exhibit(s) 17, # 19 Exhibit(s) 18, # 20 Exhibit(s) 19, # 21 Exhibit(s) 20, # 22 Exhibit(s) 21, # 23 Exhibit(s) 22, # 24 Exhibit(s) 23, # 25 Exhibit(s) 24, # 26 Exhibit(s) 25, # 27 Exhibit(s) 26, # 28 Exhibit(s) 27, # 29 Exhibit(s) 28, # 30 Exhibit(s) 29, # 31 Exhibit(s) 30, # 32 Exhibit(s) 31, # 33 Exhibit(s) 32, # 34 Exhibit(s) 33, # 35 Exhibit(s) 34, # 36 Exhibit(s) 35, # 37 Exhibit(s) 36, # 38 Exhibit(s) 37, # 39 Exhibit(s) 38, # 40 Exhibit(s) 39, # 41 Exhibit(s) 40, # 42 Exhibit(s) 41, # 43 Exhibit(s) 42, # 44 Exhibit(s) 43, # 45 Exhibit(s) 44, # 46 Exhibit(s) 45, # 47 Exhibit(s) 46, # 48 Exhibit(s) 47, # 49 Exhibit(s) 48, # 50 Exhibit(s) 49, # 51 Exhibit(s) 50, # 52 Exhibit(s) 51, # 53 Exhibit(s) 52, # 54 Cover Sheet) (Baptist, Erik) (Entered: 11/18/2022)

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Nov. 18, 2022

Nov. 18, 2022

Clearinghouse
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CERTIFICATE OF INTERESTED PERSONS/DISCLOSURE STATEMENT by Alliance for Hippocratic Medicine, American Association of Pro-Life Obstetricians & Gynecologists, American College of Pediatricians, Christian Medical & Dental Associations, George Delgado, MD, Regina Frost-Clark, MD, Shaun Jester, DO, Tyler Johnson, DO. (Clerk QC note: No affiliate entered in ECF). (Baptist, Erik) (Entered: 11/18/2022)

Nov. 18, 2022

Nov. 18, 2022

PACER
3

Request for Clerk to issue Summons filed by Alliance for Hippocratic Medicine, American Association of Pro-Life Obstetricians & Gynecologists, American College of Pediatricians, Christian Medical & Dental Associations, George Delgado, MD, Regina Frost-Clark, MD, Shaun Jester, DO, Tyler Johnson, DO. (Attachments: # 1 Summons for Robert M. Califf, # 2 Summons for Janet Woodcock, # 3 Summons for Patrizia Cavazzoni, # 4 Summons for U.S. Department of Health and Human Services, # 5 Summons for Xavier Becerra, # 6 Summons for US Attorney Chad Meacham, # 7 Summons for USAG Merrick Garland) (Baptist, Erik) (Entered: 11/18/2022)

Nov. 18, 2022

Nov. 18, 2022

PACER
4

New Case Notes: A filing fee has been paid. Pursuant to Misc. Order 6, Plaintiff is provided the Notice of Right to Consent to Proceed Before A U.S. Magistrate Judge (No magistrate judge assigned). Clerk to provide copy to plaintiff if not received electronically. (nht) (Entered: 11/18/2022)

Nov. 18, 2022

Nov. 18, 2022

PACER
5

Summons issued as to Xavier Becerra, Robert M. Califf, MD, Patrizia Cavazzoni, MD, U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Janet Woodcock, MD, U.S. Attorney, and U.S. Attorney General. (nht) (Entered: 11/18/2022)

Nov. 18, 2022

Nov. 18, 2022

PACER
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MOTION for Preliminary Injunction filed by Alliance for Hippocratic Medicine, American Association of Pro-Life Obstetricians & Gynecologists, American College of Pediatricians, Christian Medical & Dental Associations, George Delgado, MD, Regina Frost-Clark, MD, Shaun Jester, DO, Tyler Johnson, DO (Attachments: # 1 Proposed Order) (Baptist, Erik) Modified title on 12/8/2022 (daa). (Entered: 11/18/2022)

1 Proposed Order

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Nov. 18, 2022

Nov. 18, 2022

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Brief/Memorandum in Support filed by Alliance for Hippocratic Medicine, American Association of Pro-Life Obstetricians & Gynecologists, American College of Pediatricians, Christian Medical & Dental Associations, George Delgado, MD, Regina Frost-Clark, MD, Shaun Jester, DO, Tyler Johnson, DO re 6 MOTION for Injunction (Baptist, Erik) (Entered: 11/18/2022)

Nov. 18, 2022

Nov. 18, 2022

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Appendix in Support filed by Alliance for Hippocratic Medicine, American Association of Pro-Life Obstetricians & Gynecologists, American College of Pediatricians, Christian Medical & Dental Associations, George Delgado, MD, Regina Frost-Clark, MD, Shaun Jester, DO, Tyler Johnson, DO re 6 MOTION for Injunction, 7 Brief/Memorandum in Support of Motion, (Attachments: # 1 Appendix pt. 2, # 2 Appendix pt. 3, # 3 Appendix pt. 4) (Baptist, Erik) (Entered: 11/18/2022)

Nov. 18, 2022

Nov. 18, 2022

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Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Erin Morrow Hawley (Filing fee $100.00, Receipt Number ATXNDC-13334273) filed by Alliance for Hippocratic Medicine, American Association of Pro-Life Obstetricians & Gynecologists, American College of Pediatricians, Christian Medical & Dental Associations, George Delgado, MD, Regina Frost-Clark, MD, Shaun Jester, DO, Tyler Johnson, DO (Attachments: # 1 Proposed Order, # 2 Payment Receipt) (Baptist, Erik) Modified to add payment information on 12/1/2022 (cea). (Entered: 11/30/2022)

Nov. 30, 2022

Nov. 30, 2022

PACER
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ORDER granting 9 Application for Admission Pro Hac Vice of Erin Hawley. Important Reminder: Unless excused for cause, an attorney who is not an ECF user must register within 14 days of the date the attorney appears in a case pursuant to LR 5.1(f) and LCrR 49.2(g). (Ordered by Judge Matthew J. Kacsmaryk on 12/1/2022) (daa) (Entered: 12/01/2022)

Dec. 1, 2022

Dec. 1, 2022

PACER
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NOTICE of Attorney Appearance by Noah T Katzen on behalf of Xavier Becerra, Robert M. Califf, MD, Patrizia Cavazzoni, MD, U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Janet Woodcock, MD. (Filer confirms contact info in ECF is current.) (Katzen, Noah) (Entered: 12/02/2022)

Dec. 2, 2022

Dec. 2, 2022

PACER
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Joint MOTION to Extend Time to Respond to Motion and Set Briefing Schedule filed by Xavier Becerra, Robert M. Califf, MD, Patrizia Cavazzoni, MD, U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Janet Woodcock, MD (Attachments: # 1 Proposed Order) (Katzen, Noah) (Entered: 12/02/2022)

1 Proposed Order

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Dec. 2, 2022

Dec. 2, 2022

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ORDER granting 12 Plaintiffs' Joint Motion to Extend Deadlines and Set Briefing Schedule. Defendants must respond to Plaintiffs' Motion for Preliminary Injunction (ECF No. 6) on or before January 13, 2023. Plaintiffs may reply to Defendants' response on or before February 10, 2023. (Ordered by Judge Matthew J. Kacsmaryk on 12/8/2022) (daa) (Entered: 12/08/2022)

Dec. 8, 2022

Dec. 8, 2022

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Consent MOTION for Leave to File Briefs With Extended Page Limits filed by Xavier Becerra, Robert M. Califf, MD, Patrizia Cavazzoni, MD, U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Janet Woodcock, MD (Attachments: # 1 Proposed Order) (Katzen, Noah) (Entered: 12/27/2022)

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Dec. 27, 2022

Dec. 27, 2022

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ORDER granting 14 Defendants' Consent Motion for Leave to File Briefs with Extended Page Limits. (Ordered by Judge Matthew J. Kacsmaryk on 1/3/2023) (daa) (Entered: 01/03/2023)

Jan. 3, 2023

Jan. 3, 2023

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Application for Admission Pro Hac Vice with Certificate of Good Standing (Filing fee $100; Receipt number ATXNDC-13426239) filed by The Chattanooga National Memorial for the Unborn (Attachments: # 1 Additional Page(s) Certificates of Good Standing)Attorney Darald John Schaffer added to party The Chattanooga National Memorial for the Unborn(pty:am) (Schaffer, Darald) (Entered: 01/09/2023)

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Jan. 9, 2023

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MOTION to Waive Local Counsel Requirement re 16 Application for Admission Pro Hac Vice with Certificate of Good Standing (Filing fee $100; Receipt number ATXNDC-13426239) filed by The Chattanooga National Memorial for the Unborn (Schaffer, Darald) (Entered: 01/09/2023)

Jan. 9, 2023

Jan. 9, 2023

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MOTION for Leave to File Amicus Curiae Brief filed by The Chattanooga National Memorial for the Unborn with Brief/Memorandum in Support. (Attachments: # 1 Amicus Brief) (Schaffer, Darald) (Entered: 01/09/2023)

1 Amicus Brief

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Jan. 9, 2023

Jan. 9, 2023

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Unopposed MOTION to Intervene filed by Danco Laboratories, LLC (Attachments: # 1 Exhibit(s) Danco's Brief in Opposition to Plaintiff's Motion for Preliminary Injunction, # 2 Exhibit(s) Exhibit 2 - Appendix, # 3 Proposed Order Proposed Order). Party Danco Laboratories, LLC added.Attorney Ryan Patrick Brown added to party Danco Laboratories, LLC(pty:intvd) (Brown, Ryan) (Entered: 01/13/2023)

1 Exhibit(s) Danco's Brief in Opposition to Plaintiff's Motion for Preli

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Jan. 13, 2023

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Brief/Memorandum in Support filed by Danco Laboratories, LLC re 19 Unopposed MOTION to Intervene (Brown, Ryan) (Entered: 01/13/2023)

Jan. 13, 2023

Jan. 13, 2023

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CERTIFICATE OF INTERESTED PERSONS/DISCLOSURE STATEMENT by Danco Laboratories, LLC. (Clerk QC note: No affiliate entered in ECF). (Brown, Ryan) (Main Document 21 replaced with flattened image on 1/17/2023) (nht). (Entered: 01/13/2023)

Jan. 13, 2023

Jan. 13, 2023

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Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Jessica Ellsworth (Filing fee $100; Receipt number ATXNDC-13441871) filed by Danco Laboratories, LLC (Attachments: # 1 Proposed Order Proposed Order) (Brown, Ryan) (Entered: 01/13/2023)

Jan. 13, 2023

Jan. 13, 2023

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Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Kaitlyn Golden (Filing fee $100; Receipt number ATXNDC-13442009) filed by Danco Laboratories, LLC (Attachments: # 1 Proposed Order) (Brown, Ryan) (Entered: 01/13/2023)

Jan. 13, 2023

Jan. 13, 2023

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Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Philip Katz (Filing fee $100; Receipt number ATXNDC-13442025) filed by Danco Laboratories, LLC (Attachments: # 1 Proposed Order) (Brown, Ryan) (Entered: 01/13/2023)

Jan. 13, 2023

Jan. 13, 2023

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Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Marlan Golden (Filing fee $100; Receipt number ATXNDC-13442066) filed by Danco Laboratories, LLC (Attachments: # 1 Proposed Order) (Brown, Ryan) (Entered: 01/13/2023)

Jan. 13, 2023

Jan. 13, 2023

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Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Lynn Mehler (Filing fee $100; Receipt number ATXNDC-13442092) filed by Danco Laboratories, LLC (Attachments: # 1 Proposed Order) (Brown, Ryan) (Entered: 01/13/2023)

Jan. 13, 2023

Jan. 13, 2023

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Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Catherine Stetson (Filing fee $100; Receipt number ATXNDC-13442104) filed by Danco Laboratories, LLC (Attachments: # 1 Proposed Order) (Brown, Ryan) (Entered: 01/13/2023)

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Jan. 13, 2023

Jan. 13, 2023

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RESPONSE in Opposition filed by Xavier Becerra, Robert M. Califf, MD, Patrizia Cavazzoni, MD, U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Janet Woodcock, MD re: 6 MOTION for Preliminary Injunction. ***FILED USING EMERGENCY EMAIL*** (Attachments: # 1 Exhibit(s) Katzen, # 2 Exhibit(s) Lindo, # 3 Exhibit(s) Ireland, # 4 Exhibit(s) Kieltyka, # 5 Exhibit(s) Zite, # 6 Exhibit(s) Glaser, # 7 Exhibit(s) McHugh) (twd) (Entered: 01/17/2023)

1 Exhibit(s) Katzen

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Jan. 13, 2023

Jan. 13, 2023

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ORDER granting 16 Application for Admission Pro Hac Vice of Darald John Schaffer, Michael S Jennings. Important Reminder: Unless excused for cause, an attorney who is not an ECF user must register within 14 days of the date the attorney appears in a case pursuant to LR 5.1(f) and LCrR 49.2(g). (Ordered by Judge Matthew J. Kacsmaryk on 1/17/2023) (daa) (Entered: 01/17/2023)

Jan. 17, 2023

Jan. 17, 2023

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ORDER granting 17 Motion ; granting 18 The Chattanooga National Memorial for the Unborn's Motion for Leave to File a Brief as Amicus Curiae in Support of Plaintiff's Complaint and Motion for Temporary Injunction. (Ordered by Judge Matthew J. Kacsmaryk on 1/17/2023) (daa) (Entered: 01/17/2023)

Jan. 17, 2023

Jan. 17, 2023

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AMICUS Brief in Support filed by The Chattanooga National Memorial for the Unborn re 1 Complaint. (daa) (Entered: 01/19/2023)

Jan. 17, 2023

Jan. 17, 2023

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32

ORDER: On or before February 10, 2023, the parties are ORDERED to submit separate briefs on whether the Court should consolidate the injunction hearing and the trial on the merits pursuant to Federal Rule of Civil Procedure 65(a)(2). (Ordered by Judge Matthew J. Kacsmaryk on 2/3/2023) (awc) (Entered: 02/03/2023)

Feb. 3, 2023

Feb. 3, 2023

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33

ORDER granting 19 Danco Laboratories, LLC's ("Danco") Unopposed Motion for Leave to Intervene. (Ordered by Judge Matthew J. Kacsmaryk on 2/6/2023) (daa) (Entered: 02/06/2023)

Feb. 6, 2023

Feb. 6, 2023

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34

ORDER granting 27 Application for Admission Pro Hac Vice of Catherine Emily Stetson. Important Reminder: Unless excused for cause, an attorney who is not an ECF user must register within 14 days of the date the attorney appears in a case pursuant to LR 5.1(f) and LCrR 49.2(g). (Ordered by Judge Matthew J. Kacsmaryk on 2/6/2023) (daa) (Entered: 02/07/2023)

Feb. 6, 2023

Feb. 6, 2023

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ORDER granting 26 Application for Admission Pro Hac Vice of Lynn Whipkey Mehler. Important Reminder: Unless excused for cause, an attorney who is not an ECF user must register within 14 days of the date the attorney appears in a case pursuant to LR 5.1(f) and LCrR 49.2(g). (Ordered by Judge Matthew J. Kacsmaryk on 2/6/2023) (daa) (Entered: 02/07/2023)

Feb. 6, 2023

Feb. 6, 2023

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ORDER granting 25 Application for Admission Pro Hac Vice of Marlan Golden. Important Reminder: Unless excused for cause, an attorney who is not an ECF user must register within 14 days of the date the attorney appears in a case pursuant to LR 5.1(f) and LCrR 49.2(g). (Ordered by Judge Matthew J. Kacsmaryk on 2/6/2023) (daa) (Entered: 02/07/2023)

Feb. 6, 2023

Feb. 6, 2023

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ORDER granting 24 Application for Admission Pro Hac Vice of Philip Katz. Important Reminder: Unless excused for cause, an attorney who is not an ECF user must register within 14 days of the date the attorney appears in a case pursuant to LR 5.1(f) and LCrR 49.2(g). (Ordered by Judge Matthew J. Kacsmaryk on 2/6/2023) (daa) (Entered: 02/07/2023)

Feb. 6, 2023

Feb. 6, 2023

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38

ORDER granting 23 Application for Admission Pro Hac Vice of Kaitlyn Golden. Important Reminder: Unless excused for cause, an attorney who is not an ECF user must register within 14 days of the date the attorney appears in a case pursuant to LR 5.1(f) and LCrR 49.2(g). (Ordered by Judge Matthew J. Kacsmaryk on 2/6/2023) (daa) (Entered: 02/07/2023)

Feb. 6, 2023

Feb. 6, 2023

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ORDER granting 22 Application for Admission Pro Hac Vice of Jessica Lynn Ellsworth. Important Reminder: Unless excused for cause, an attorney who is not an ECF user must register within 14 days of the date the attorney appears in a case pursuant to LR 5.1(f) and LCrR 49.2(g). (Ordered by Judge Matthew J. Kacsmaryk on 2/6/2023) (daa) (Entered: 02/07/2023)

Feb. 6, 2023

Feb. 6, 2023

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40

Application for Admission Pro Hac Vice with Certificate of Good Standing (Filing fee $100; Receipt number ATXNDC-13504121) filed by Doctors for America (Attachments: # 1 Proposed Order). Party Doctors for America added.Attorney Christopher Morten added to party Doctors for America(pty:am) (Morten, Christopher) (Entered: 02/09/2023)

1 Proposed Order

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Feb. 9, 2023

Feb. 9, 2023

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41

MOTION to Waive Local Counsel Requirement filed by Doctors for America (Attachments: # 1 Proposed Order) (Morten, Christopher) (Entered: 02/09/2023)

1 Proposed Order

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Feb. 9, 2023

Feb. 9, 2023

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42

Unopposed MOTION for Leave to File Amicus Brief filed by Doctors for America (Attachments: # 1 Amicus Brief of Doctors for America, # 2 Proposed Order) (Morten, Christopher) (Entered: 02/09/2023)

1 Amicus Brief of Doctors for America

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2 Proposed Order

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Feb. 9, 2023

Feb. 9, 2023

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43

ORDER: On February 6, 2023, the Court granted Danco Laboratories, LLC's ("Danco") motion to intervene. ECF No. 33. Accordingly, the Court hereby ORDERS Danco to promptly file its brief in opposition to Plaintiff's motion for a preliminary injunction (ECF No. 19-1 ). Plaintiffs may file any reply to Defendants' responses to the motion for preliminary injunction on or before February 24, 2023. (Ordered by Judge Matthew J. Kacsmaryk on 2/9/2023) (daa) (Entered: 02/09/2023)

Feb. 9, 2023

Feb. 9, 2023

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44

MOTION to Waive Local Rule 83.10(a) (Unopposed) filed by American Center for Law and Justice (Attachments: # 1 Proposed Order)Attorney Edward Lawrence White, III added to party American Center for Law and Justice(pty:am) (White, Edward) (Entered: 02/10/2023)

1 Proposed Order

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Feb. 10, 2023

Feb. 10, 2023

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45

Unopposed MOTION for Leave to File Amicus Curiae Brief in Support of Plaintiffs' Motion for Preliminary Injunction filed by American Center for Law and Justice (Attachments: # 1 Amicus Curiae Brief, # 2 Proposed Order) (White, Edward) (Entered: 02/10/2023)

1 Amicus Curiae Brief

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2 Proposed Order

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Feb. 10, 2023

Feb. 10, 2023

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46

Application for Admission Pro Hac Vice with Certificate of Good Standing (Filing fee $100; Receipt number ATXNDC-13507946) filed by State of Missouri (Attachments: # 1 Proposed Order). Party State of Missouri added.Attorney Joshua Divine added to party State of Missouri(pty:am) (Divine, Joshua) (Entered: 02/10/2023)

1 Proposed Order

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Feb. 10, 2023

Feb. 10, 2023

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47

MOTION for Leave to File Motion for Leave to Proceed without Local Counsel filed by State of Missouri (Attachments: # 1 Proposed Order) (Divine, Joshua) (Entered: 02/10/2023)

1 Proposed Order

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Feb. 10, 2023

Feb. 10, 2023

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48

Unopposed MOTION for Leave to File Amicus Brief filed by State of Missouri (Attachments: # 1 Proposed Order, # 2 Attachment: Amicus Brief, # 3 Attachment: Appendix) (Divine, Joshua) (Entered: 02/10/2023)

1 Proposed Order

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2 Attachment: Amicus Brief

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3 Attachment: Appendix

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Feb. 10, 2023

Feb. 10, 2023

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49

NOTICE of Attorney Appearance by Elissa Michelle Graves on behalf of Human Coalition. (Filer confirms contact info in ECF is current.) (Graves, Elissa) (Entered: 02/10/2023)

Feb. 10, 2023

Feb. 10, 2023

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50

RESPONSE filed by Danco Laboratories, LLC re: 6 MOTION for Injunction (Brown, Ryan) (Entered: 02/10/2023)

Feb. 10, 2023

Feb. 10, 2023

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51

MOTION for Leave to File Brief Amicus Curiae filed by Human Coalition (Attachments: # 1 Proposed Amicus Brief, # 2 Proposed Order) (Graves, Elissa) (Entered: 02/10/2023)

1 Proposed Amicus Brief

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2 Proposed Order

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Feb. 10, 2023

Feb. 10, 2023

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52

Appendix in Support filed by Danco Laboratories, LLC re 50 Response/Objection to Plaintif's Motion for Preliminary Injunction (Brown, Ryan) (Entered: 02/10/2023)

Feb. 10, 2023

Feb. 10, 2023

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53

MOTION for Leave to File Motion for Leave to Proceed Without Local Counsel filed by State of Mississippi (Attachments: # 1 Proposed Order). Party States of Mississippi, Alabama, Alaska, Arkansas, Florida, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Montana, Nebraska, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, and Wyoming added.Attorney Justin Lee Matheny added to party State of Mississippi(pty:am) (Matheny, Justin) (Entered: 02/10/2023)

1 Proposed Order

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Feb. 10, 2023

Feb. 10, 2023

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54

Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney M. Edward Whelan III (Filing fee $100; Receipt number ATXNDC-13508325) filed by Ethics and Public Policy Center (Attachments: # 1 Proposed Order). Party Ethics and Public Policy Center added.Attorney Charles W Fillmore added to party Ethics and Public Policy Center(pty:!!!) (Fillmore, Charles) (Main Document 54 replaced on 2/10/2023) (daa). (Attachment 1 replaced on 2/10/2023) (daa). (Entered: 02/10/2023)

1 Proposed Order

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Feb. 10, 2023

Feb. 10, 2023

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55

Unopposed MOTION for Leave to File Motion for Leave to File Amicus Brief filed by State of Mississippi (Attachments: # 1 Exhibit(s) Proposed Amicus Brief, # 2 Proposed Order) (Matheny, Justin) (Entered: 02/10/2023)

1 Exhibit(s) Proposed Amicus Brief

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2 Proposed Order

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Feb. 10, 2023

Feb. 10, 2023

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56

MOTION for Leave to File Amicus Brief on Behalf of Ethics and Public Policy Center in Support of Plaintiffs filed by Ethics and Public Policy Center with Brief/Memorandum in Support. (Attachments: # 1 Exhibit(s) Amicus Brief on Behalf of Ethics and Public Policy Center in Support of Plaintiffs, # 2 Proposed Order) (Fillmore, Charles) (Entered: 02/10/2023)

1 Exhibit(s) Amicus Brief on Behalf of Ethics and Public Policy Center in Support

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2 Proposed Order

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Feb. 10, 2023

Feb. 10, 2023

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57

Application for Admission Pro Hac Vice with Certificate of Good Standing (Filing fee $100; Receipt number ATXNDC-13508285) filed by State of New York (Attachments: # 1 Declaration(s), # 2 Proposed Order)Attorney Galen Sherwin added to party State of New York(pty:am) (Sherwin, Galen) (Entered: 02/10/2023)

1 Declaration(s)

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2 Proposed Order

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Feb. 10, 2023

Feb. 10, 2023

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58

MOTION for Leave to File Brief of Amicus Curiae Life Collective Inc. filed by Life Collective Inc. (Attachments: # 1 Exhibit(s) Proposed Amicus Brief). Party Life Collective Inc. added.Attorney Darren L McCarty added to party Life Collective Inc.(pty:am) (McCarty, Darren) (Entered: 02/10/2023)

1 Exhibit(s) Proposed Amicus Brief

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Feb. 10, 2023

Feb. 10, 2023

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59

Unopposed MOTION for Leave to File Brief as Amici Curiae in Support of Defendants and in Opposition to Plaintiffs' Motion for Preliminary Injunction filed by State of New York with Brief/Memorandum in Support. (Attachments: # 1 Exhibit(s), # 2 Proposed Order) (Sherwin, Galen) (Entered: 02/10/2023)

1 Exhibit(s)

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2 Proposed Order

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Feb. 10, 2023

Feb. 10, 2023

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60

MOTION Waiver of Local Rule 83.10(a) filed by Life Collective Inc. (McCarty, Darren) (Entered: 02/10/2023)

Feb. 10, 2023

Feb. 10, 2023

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61

Application for Admission Pro Hac Vice with Certificate of Good Standing (Filing fee $100; Receipt number ATXNDC-13508815) filed by Family Research Council (Attachments: # 1 Proposed Order). Party Family Research Council added.Attorney Michael F Smith added to party Family Research Council(pty:am) (Smith, Michael) (Entered: 02/10/2023)

1 Proposed Order

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Feb. 10, 2023

Feb. 10, 2023

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62

MOTION Waive Local Counsel Requirement of LR 83.10 filed by Family Research Council (Attachments: # 1 Proposed Order) (Smith, Michael) (Entered: 02/10/2023)

1 Proposed Order

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Feb. 10, 2023

Feb. 10, 2023

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63

Unopposed MOTION for Leave to File Amicus Curiae brief filed by Family Research Council with Brief/Memorandum in Support. (Attachments: # 1 Exhibit(s) Amicus Brief, # 2 Proposed Order) (Smith, Michael) (Entered: 02/10/2023)

1 Exhibit(s) Amicus Brief

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2 Proposed Order

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Feb. 10, 2023

Feb. 10, 2023

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64

MOTION for Leave to File Waive Requirement for Local Counsel filed by Judicial Watch (Attachments: # 1 Proposed Order). Party Judicial Watch, Inc. added.Attorney Meredith Di Liberto added to party Judicial Watch(pty:am) (Di Liberto, Meredith) (Entered: 02/10/2023)

1 Proposed Order

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Feb. 10, 2023

Feb. 10, 2023

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65

Unopposed MOTION for Leave to File to File An Amicus Curiae Brief in Support of Plaintiffs filed by Judicial Watch with Brief/Memorandum in Support. (Attachments: # 1 Exhibit(s) Amicus Curiae Brief of Judicial Watch, Inc. in Support of Plaintifss, # 2 Exhibit(s) Appendix to Amicus Curiae Brief of Judicial Watch in Support of Plaintiffs, # 3 Proposed Order) (Di Liberto, Meredith) (Entered: 02/10/2023)

1 Exhibit(s) Amicus Curiae Brief of Judicial Watch, Inc. in Support of Plaintifss

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2 Exhibit(s) Appendix to Amicus Curiae Brief of Judicial Watch in Support of Plain

View on RECAP

3 Proposed Order

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Feb. 10, 2023

Feb. 10, 2023

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66

Unopposed MOTION for Leave to File AAF Amicus Brief filed by Advancing American Freedom with Brief/Memorandum in Support. (Attachments: # 1 Exhibit(s) AAF Amicus brief). Party Advancing American Freedom added.Attorney Marc Wheat added to party Advancing American Freedom(pty:am) (Wheat, Marc) (Entered: 02/10/2023)

1 Exhibit(s) AAF Amicus brief

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Feb. 10, 2023

Feb. 10, 2023

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67

Application for Admission Pro Hac Vice with Certificate of Good Standing (Filing fee $100; Receipt number ATXNDC-13509386) filed by Advancing American Freedom (Attachments: # 1 Exhibit(s) Good Standing Virginia cert.) (Wheat, Marc) (Entered: 02/10/2023)

1 Exhibit(s) Good Standing Virginia cert.

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Feb. 10, 2023

Feb. 10, 2023

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68

Brief/Memorandum in Support filed by Alliance for Hippocratic Medicine, American Association of Pro-Life Obstetricians & Gynecologists, American College of Pediatricians, Christian Medical & Dental Associations, George Delgado, MD, Regina Frost-Clark, MD, Shaun Jester, DO, Tyler Johnson, DO re 32 Order Setting Deadline/Hearing, re Consolidating the Preliminary Injunction Hearing with a Trial on the Merits Under Rule 65(a)(2) (Blake, Julie) (Entered: 02/10/2023)

Feb. 10, 2023

Feb. 10, 2023

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69

Application for Admission Pro Hac Vice without Certificate of Good Standing (Filing fee $100; Receipt number ATXNDC-13509192) filed by Concerned Women for America with Brief/Memorandum in Support. (Attachments: # 1 Motion for Leave to File as Amicus Curiae, # 2 Amicus Curiae Brief). Party Concerned Women for America added.Attorney Mario Diaz added to party Concerned Women for America(pty:am) (Diaz, Mario) (Entered: 02/10/2023)

1 Motion for Leave to File as Amicus Curiae

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2 Amicus Curiae Brief

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Feb. 10, 2023

Feb. 10, 2023

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70

MOTION for Leave to File Brief of Food and Drug Law Scholars as Amici Curiae in Support of Defendants Opposition to Plaintiff's Motion for Preliminary Injunction filed by Greer Donley, Patricia Zettler, R. Alta Charo, I. Glenn Cohen, Marsha Cohen, Nathan Cortez, Rebecca Eisenberg, Henry Greely, George Horvath, Peter Barton Hutt, Joan Krause, Holly Fernandez Lynch, Elizabeth McCuskey, Jennifer Oliva, Jordan Paradise, Christopher Robertson, Joanna Sax, Allison Whelan, Diana Winters (Attachments: # 1 Brief of Food and Drug Law Scholars as Amici Curiae in Support of Defendants Opposition to Plaintiffs Motion for Preliminary Injunction) Attorney Robert John Winson added. (Winson, Robert) Docket text modified on 2/13/2023 (twd). (Entered: 02/10/2023)

1 Brief of Food and Drug Law Scholars as Amici Curiae in Support of Defendants Op

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Feb. 10, 2023

Feb. 10, 2023

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71

Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Lewis A. Grossman (Filing fee $100; Receipt number ATXNDC-13509907) filed by R. Alta Charo, I. Glenn Cohen, Marsha Cohen, Nathan Cortez, Greer Donley, Rebecca Eisenberg, Henry Greely, George Horvath, Peter Barton Hutt, Joan Krause, Holly Fernandez Lynch, Elizabeth McCuskey, Jennifer Oliva, Jordan Paradise, Christopher Robertson, Joanna Sax, Allison Whelan, Diana Winters, Patricia Zettler (Attachments: # 1 Certificate of Good Standing) (Winson, Robert) (Entered: 02/10/2023)

1 Certificate of Good Standing

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Feb. 10, 2023

Feb. 10, 2023

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72

Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Denise Esposito (Filing fee $100; Receipt number ATXNDC-13509965) filed by R. Alta Charo, I. Glenn Cohen, Marsha Cohen, Nathan Cortez, Greer Donley, Rebecca Eisenberg, Henry Greely, George Horvath, Peter Barton Hutt, Joan Krause, Holly Fernandez Lynch, Elizabeth McCuskey, Jennifer Oliva, Jordan Paradise, Christopher Robertson, Joanna Sax, Allison Whelan, Diana Winters, Patricia Zettler (Attachments: # 1 Certificate of Good Standing) (Winson, Robert) (Entered: 02/10/2023)

1 Certificate of Good Standing

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Feb. 10, 2023

Feb. 10, 2023

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73

Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Robert A. Long (Filing fee $100; Receipt number ATXNDC-13509987) filed by R. Alta Charo, I. Glenn Cohen, Marsha Cohen, Nathan Cortez, Greer Donley, Rebecca Eisenberg, Henry Greely, George Horvath, Peter Barton Hutt, Joan Krause, Holly Fernandez Lynch, Elizabeth McCuskey, Jennifer Oliva, Jordan Paradise, Christopher Robertson, Joanna Sax, Allison Whelan, Diana Winters, Patricia Zettler (Attachments: # 1 Certificate of Good Standing) (Winson, Robert) (Entered: 02/10/2023)

1 Certificate of Good Standing

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Feb. 10, 2023

Feb. 10, 2023

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74

Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Julia F. Post (Filing fee $100; Receipt number ATXNDC-13510002) filed by R. Alta Charo, I. Glenn Cohen, Marsha Cohen, Nathan Cortez, Greer Donley, Rebecca Eisenberg, Henry Greely, George Horvath, Peter Barton Hutt, Joan Krause, Holly Fernandez Lynch, Elizabeth McCuskey, Jennifer Oliva, Jordan Paradise, Christopher Robertson, Joanna Sax, Allison Whelan, Diana Winters, Patricia Zettler (Attachments: # 1 Certificate of Good Standing) (Winson, Robert) (Entered: 02/10/2023)

1 Certificate of Good Standing

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Feb. 10, 2023

Feb. 10, 2023

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75

Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Beth Braiterman (Filing fee $100; Receipt number ATXNDC-13510021) filed by R. Alta Charo, I. Glenn Cohen, Marsha Cohen, Nathan Cortez, Greer Donley, Rebecca Eisenberg, Henry Greely, George Horvath, Peter Barton Hutt, Joan Krause, Holly Fernandez Lynch, Elizabeth McCuskey, Jennifer Oliva, Jordan Paradise, Christopher Robertson, Joanna Sax, Allison Whelan, Diana Winters, Patricia Zettler (Attachments: # 1 Certificate of Good Standing) (Winson, Robert) (Entered: 02/10/2023)

1 Certificate of Good Standing

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Feb. 10, 2023

Feb. 10, 2023

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76

**STRICKEN per 106 ** REPLY filed by Alliance for Hippocratic Medicine, American Association of Pro-Life Obstetricians & Gynecologists, American College of Pediatricians, Christian Medical & Dental Associations, George Delgado, MD, Regina Frost-Clark, MD, Shaun Jester, DO, Tyler Johnson, DO re: 6 MOTION for Injunction (Baptist, Erik) Modified on 2/13/2023 (nht). (Entered: 02/10/2023)

Feb. 10, 2023

Feb. 10, 2023

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77

Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Emile Katz (Filing fee $100; Receipt number ATXNDC-13510042) filed by R. Alta Charo, I. Glenn Cohen, Marsha Cohen, Nathan Cortez, Greer Donley, Rebecca Eisenberg, Henry Greely, George Horvath, Peter Barton Hutt, Joan Krause, Holly Fernandez Lynch, Elizabeth McCuskey, Jennifer Oliva, Jordan Paradise, Christopher Robertson, Joanna Sax, Allison Whelan, Diana Winters, Patricia Zettler (Attachments: # 1 Certificate of Good Standing) (Winson, Robert) (Entered: 02/10/2023)

1 Certificate of Good Standing

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Feb. 10, 2023

Feb. 10, 2023

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78

Application for Admission Pro Hac Vice with Certificate of Good Standing (Filing fee $100; Receipt number ATXNDC-13509981) filed by American College of Obstetricians and Gynecologists (Attachments: # 1 Proposed Order, # 2 Exhibit(s)). Party American College of Obstetricians and Gynecologists added.Attorney Molly A Meegan added to party American College of Obstetricians and Gynecologists(pty:am) (Meegan, Molly) (Main Document 78 replaced with flattened document on 2/13/2023) (awc). (Attachment 1 replaced with flattened document on 2/13/2023) (awc). (Entered: 02/10/2023)

1 Proposed Order

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2 Exhibit(s)

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Feb. 10, 2023

Feb. 10, 2023

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79

**STRICKEN per 106 ** Appendix in Support filed by Alliance for Hippocratic Medicine, American Association of Pro-Life Obstetricians & Gynecologists, American College of Pediatricians, Christian Medical & Dental Associations, George Delgado, MD, Regina Frost-Clark, MD, Shaun Jester, DO, Tyler Johnson, DO re 76 Reply, in Support of Motion for Preliminary Injunction (Baptist, Erik) Modified on 2/13/2023 (nht). (Entered: 02/10/2023)

Feb. 10, 2023

Feb. 10, 2023

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80

Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Guillaume Julian (Filing fee $100; Receipt number ATXNDC-13510079) filed by R. Alta Charo, I. Glenn Cohen, Marsha Cohen, Nathan Cortez, Greer Donley, Rebecca Eisenberg, Henry Greely, George Horvath, Peter Barton Hutt, Joan Krause, Holly Fernandez Lynch, Elizabeth McCuskey, Jennifer Oliva, Jordan Paradise, Christopher Robertson, Joanna Sax, Allison Whelan, Diana Winters, Patricia Zettler (Attachments: # 1 Certificate of Good Standing) (Winson, Robert) (Entered: 02/10/2023)

1 Certificate of Good Standing

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Feb. 10, 2023

Feb. 10, 2023

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81

MOTION for Leave to File Amicus Brief filed by Murphy Klasing, Susan B. Anthony Pro-Life America, Catholic Health Care Leadership Alliance, The National Catholic Bioethics Center, Catholic Bar Association, Catholic Benefits Association, Christ Medicus Foundation with Brief/Memorandum in Support. (Attachments: # 1 Proposed Order). Attorney Murphy S Klasing added. (Klasing, Murphy) Docket text modified on 2/13/2023 (twd). (Entered: 02/10/2023)

1 Proposed Order

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Feb. 10, 2023

Feb. 10, 2023

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82

Amicus Brief filed by Catholic Bar Association, Catholic Benefits Association, Catholic Health Care Leadership Alliance, Christ Medicus Foundation, Susan B. Anthony Pro-Life America, The National Catholic Bioethics Center re 6 MOTION for Injunction . (Klasing, Murphy) Docket text modified on 2/13/2023 (twd). (Entered: 02/10/2023)

Feb. 10, 2023

Feb. 10, 2023

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83

Unopposed MOTION for Leave to File Brief as Amici Curiae in Support of Plaintiffs' Motion for a Preliminary Injunction filed by 67 Members of Congress with Brief/Memorandum in Support. Attorney Fernando M Bustos added to party 67 Members of Congress(pty:am) (Bustos, Fernando) (Entered: 02/10/2023)

Feb. 10, 2023

Feb. 10, 2023

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84

Brief/Memorandum in Support filed by 67 Members of Congress re 83 Unopposed MOTION for Leave to File Brief as Amici Curiae in Support of Plaintiffs' Motion for a Preliminary Injunction (Bustos, Fernando) (Entered: 02/10/2023)

Feb. 10, 2023

Feb. 10, 2023

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85

Appendix in Support filed by 67 Members of Congress re 84 Brief/Memorandum in Support of Motion (Bustos, Fernando) (Entered: 02/10/2023)

Feb. 10, 2023

Feb. 10, 2023

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86

Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Carolyn McDonnell (Filing fee $100; Receipt number ATXNDC-13510239) filed by 67 Members of Congress (Bustos, Fernando) (Entered: 02/10/2023)

Feb. 10, 2023

Feb. 10, 2023

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87

Application for Admission Pro Hac Vice with Certificate of Good Standing (Filing fee $100; Receipt number ATXNDC-13510418) filed by American College of Obstetricians and Gynecologists, American Medical Association, Society of Maternal and Fetal Medicine, American Academy of Family Physicians, American Gynecological & Obstetrical Society, American Society for Reproductive Medicine, Council of University Chairs of Obstetrics & Gynecology, North American Society for Pediatric and Adolescent Gynecology, Nurse Practitioners in Women's Health, Society of Family Planning, Society of Gynecologic Oncology, Society of OB/GYN Hospitalists. Party American College of Obstetricians and Gynecologists added. Attorney Shannon Rose Selden added. (Selden, Shannon) Docket text modified on 2/13/2023 (twd). (Entered: 02/10/2023)

Feb. 10, 2023

Feb. 10, 2023

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88

Application for Admission Pro Hac Vice with Certificate of Good Standing (Filing fee $100; Receipt number ATXNDC-13510608) filed by American Academy of Family Physicians, American College of Obstetricians and Gynecologists, American Gynecological & Obstetrical Society, American Medical Association, American Society for Reproductive Medicine, Council of University Chairs of Obstetrics & Gynecology, North American Society for Pediatric and Adolescent Gynecology, Nurse Practitioners in Women's Health, Society of Family Planning, Society of Gynecologic Oncology, Society of Maternal and Fetal Medicine, Society of OB/GYN Hospitalists Attorney Adam Bresler Aukland-Peck added. (Aukland-Peck, Adam) Docket text modified on 2/13/2023 (twd). (Entered: 02/10/2023)

Feb. 10, 2023

Feb. 10, 2023

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89

Unopposed MOTION for Leave to File Brief of Amici Curiae in Support of Plaintiffs' Motion for Preliminary Injunction filed by Texas Business Leaders (Attachments: # 1 Exhibit(s) Amicus Brief, # 2 Proposed Order Proposed Order). Attorney John Clay Sullivan added. (pty:am) (Sullivan, John) Docket text modified on 2/13/2023 (twd). (Entered: 02/10/2023)

1 Exhibit(s) Amicus Brief

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2 Proposed Order Proposed Order

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Feb. 10, 2023

Feb. 10, 2023

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90

MOTION Proceed without Local Counsel filed by Texas Business Leaders (Sullivan, John) (Entered: 02/10/2023)

Feb. 10, 2023

Feb. 10, 2023

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91

Unopposed MOTION for Leave to File to File Amici Curiae filed by American Academy of Family Physicians, American College of Obstetricians and Gynecologists, American Gynecological & Obstetrical Society, American Medical Association, American Society for Reproductive Medicine, Council of University Chairs of Obstetrics & Gynecology, North American Society for Pediatric and Adolescent Gynecology, Nurse Practitioners in Women's Health, Society of Family Planning, Society of Gynecologic Oncology, Society of Maternal and Fetal Medicine, Society of OB/GYN Hospitalists (Attachments: # 1 Exhibit(s) Amicus Brief, # 2 Proposed Order Proposed Order) (Sherwood, Matthew) (Entered: 02/10/2023)

1 Exhibit(s) Amicus Brief

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2 Proposed Order Proposed Order

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Feb. 10, 2023

Feb. 10, 2023

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92

Brief/Memorandum in Support filed by Danco Laboratories LLC re 32 Order Setting Deadline/Hearing, Notice of Danco's Position on Consolidation Under Rule 65(a)(2) (Ellsworth, Jessica) (Entered: 02/10/2023)

Feb. 10, 2023

Feb. 10, 2023

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93

NOTICE of Attorney Appearance by Kate Talmor-DOJ on behalf of Xavier Becerra, Robert M. Califf, MD, Patrizia Cavazzoni, MD, U.S. Department of Health and Human Services, US Food and Drug Administration, Janet Woodcock, MD. (Filer confirms contact info in ECF is current.) (Talmor-DOJ, Kate) (Entered: 02/10/2023)

Feb. 10, 2023

Feb. 10, 2023

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94

ORDER granting 40 Application for Admission Pro Hac Vice ; granting 41 Motion to Waive Local Counsel ; granting 42 Motion for Leave to File ; granting 44 Motion to Waive Local Counsel ; granting 45 Motion for Leave to File ; granting 46 Application for Admission Pro Hac Vice ; granting 47 Motion for Leave to File ; granting 48 Motion for Leave to File ; granting 51 Motion for Leave to File ; granting 53 Motion for Leave to File ; granting 54 Application for Admission Pro Hac Vice ; granting 55 Motion for Leave to File ; granting 56 Motion for Leave to File ; granting 57 Application for Admission Pro Hac Vice ; granting 58 Motion for Leave to File ; granting 59 Motion for Leave to File ; granting 60 Motion to Waive Local Counsel ; granting 61 Application for Admission Pro Hac Vice ; granting 62 Motion to Waive Local Counsel ; granting 63 Motion for Leave to File ; granting 64 Motion for Leave to File ; granting 65 Motion for Leave to File ; granting 66 Motion for Leave to File ; granting 67 Application for Admission Pro Hac Vice ; granting 69 Application for Admission Pro Hac Vice ; granting 70 Motion for Leave to File ; granting 71 Application for Admission Pro Hac Vice ; granting 72 Application for Admission Pro Hac Vice ; granting 73 Application for Admission Pro Hac Vice ; granting 74 Application for Admission Pro Hac Vice ; granting 75 Application for Admission Pro Hac Vice ; granting 77 Application for Admission Pro Hac Vice ; granting 80 Application for Admission Pro Hac Vice ; granting 81 Motion for Leave to File ; granting 83 Motion for Leave to File ; granting 86 Application for Admission Pro Hac Vice. NOTICE TO ATTORNEYS - IMPORTANT REMINDER: Unless excused for cause, an attorney who is not an ECF user must register within 14 days of the date the attorney appears in a case pursuant to LR 5.1(f) and LCrR 49.2(g). (Ordered by Judge Matthew J. Kacsmaryk on 2/10/2023) (daa) (Entered: 02/10/2023)

Feb. 10, 2023

Feb. 10, 2023

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95

Amicus Brief filed by Family Research Council re 6 MOTION for Injunction, 1 Complaint. (Smith, Michael) Docket text modified on 2/13/2023 (twd). (Entered: 02/10/2023)

Feb. 10, 2023

Feb. 10, 2023

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Amicus Brief filed by Human Coalition re 6 MOTION for Injunction. (Graves, Elissa) Docket text modified on 2/13/2023 (twd). (Entered: 02/10/2023)

Feb. 10, 2023

Feb. 10, 2023

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97

MOTION for Leave to File Amicus Brief and Exceed Page Limit filed by Charlotte Lozier Institute with Brief/Memorandum in Support. (Attachments: # 1 Brief of Proposed Amicus Curiae Charlotte Lozier Institute in Support of Plaintiffs' Motion for Preliminary Injunction, # 2 Proposed Order). Party Charlotte Lozier Institute added.Attorney Cristina Martinez Squiers added to party Charlotte Lozier Institute(pty:am) (Squiers, Cristina) (Entered: 02/10/2023)

1 Brief of Proposed Amicus Curiae Charlotte Lozier Institute in Support of Plaint

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2 Proposed Order

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Feb. 10, 2023

Feb. 10, 2023

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98

OBJECTION filed by Xavier Becerra, Robert M. Califf, MD, Patrizia Cavazzoni, MD, U.S. Department of Health and Human Services, US Food and Drug Administration, Janet Woodcock, MD re: 32 Order Setting Deadline/Hearing, (Talmor-DOJ, Kate) (Entered: 02/10/2023)

Feb. 10, 2023

Feb. 10, 2023

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Amicus Brief filed by Doctors for America. (Morten, Christopher) Docket text modified on 2/13/2023 (twd). (Entered: 02/13/2023)

Feb. 13, 2023

Feb. 13, 2023

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Amicus Brief filed by State of Alabama, State of Alaska, State of Arkansas, State of Florida, State of Georgia, State of Idaho, State of Indiana, State of Iowa, State of Kansas, State of Kentucky, State of Louisiana, State of Mississippi, State of Montana, State of Nebraska, State of Ohio, State of Oklahoma, State of South Carolina, State of South Dakota, State of Tennessee, State of Texas, State of Utah, State of Wyoming re 6 MOTION for Injunction. (Matheny, Justin) Docket text modified on 2/13/2023 (twd). (Entered: 02/13/2023)

Feb. 13, 2023

Feb. 13, 2023

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Case Details

State / Territory: Texas

Case Type(s):

Reproductive Issues

Key Dates

Filing Date: Nov. 18, 2022

Case Ongoing: Yes

Plaintiffs

Plaintiff Description:

Four national medical associations and four doctors experienced in caring for pregnant and post-abortive patients.

Plaintiff Type(s):

Private Plaintiff

Non-profit religious organization

Non-profit NON-religious organization

Attorney Organizations:

Alliance Defending Freedom

Public Interest Lawyer: Yes

Filed Pro Se: No

Class Action Sought: No

Class Action Outcome: Not sought

Defendants

U.S. Food & Drug Administration (- United States (national) -), Federal

U.S. Department of Health & Human Services (- United States (national) -), Federal

Danco Laboratories, LLC (New York), Private Entity/Person

Defendant Type(s):

Jurisdiction-wide

Case Details

Causes of Action:

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

Available Documents:

Trial Court Docket

Complaint (any)

Injunctive (or Injunctive-like) Relief

Any published opinion

Outcome

Prevailing Party: None Yet / None

Nature of Relief:

Preliminary injunction / Temp. restraining order

Source of Relief:

Litigation

Content of Injunction:

Preliminary relief granted

Issues

Reproductive rights:

Medication abortion

Telemedicine

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

Abortion

Affected Sex or Gender:

Female