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 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 United States Supreme Court. On December 13, 2023, the Supreme Court granted cert in both cases, consolidating the oral argument. The Supreme Court heard oral argument on March 26, 2024.

The Supreme Court held 9-0 that plaintiffs lacked standing to challenge the FDA's actions on June 13, 2024. In an opinion delivered by Justice Kavanaugh, the Court held that plaintiffs failed to demonstrate that FDA's relaxed regulatory requirements would cause them an injury for Article III standing purposes. The required causal chain for standing was broken because the Emergency Medical Treatment and Labor Act (EMTALA) guidance offered by FDA and challenged by plaintiffs did not override federal conscience laws or require individual physicians to participate in emergency abortions. Plaintiffs' alleged downstream economic injuries (diversion of resources and time from other patients to treat patients with mifepristone complications; potentially increasing insurance costs; etc.) were too speculative. Alliance for Hippocratic Medicine's organizational standing argument also failed muster because intensity of interest in an issue was insufficient for an organization to claim standing. Therefore, federal courts were an improper forum for plaintiffs' concerns. Plaintiffs final argument for standing, that if they did not have standing, no one would have standing to challenge the FDA's 2016 and 2021 actions, also failed because the Court long recognized that some issues were left to political and democratic processes

Justice Thomas wrote a concurrence to highlight his objection to third-party standing doctrine and organizational standing, or associational standing, which he argued was simply another form of third-party standing. Justice Thomas' issues with associational standing included that it overly relaxed the injury and redressability requirements for standing.

The next month, on October 11, Idaho, Kansas and Missouri filed a motion for leave to file an amended complaint. In the proposed amended complaint, the intervenor states, suing under the Administrative Procedure Act (APA), argued 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. The intervenors alleged they suffered several injuries, including interference with enforcement of state abortion laws, economic injuries to the states’ medical systems, and injuries to the states’ population interests.

The amended complaint does not challenge the drug’s original approval, nor does it call for the FDA to vacate its original approval or declare that mifepristone and misoprostol fall outside the scope of the FDA’s regulation, as the original complaint did. The amended complaint asks the Court to reinstate the drug’s 2016 risk evaluation and mitigation strategy (REMS), rescind the 2019 generic approval and reinstate the in-person dispensing requirement. It also asks the Court to hold unlawful “the provision of drugs to adolescent populations because the FDA lacked authority under § 355c(a)(2)(B)(i) to extrapolate pediatric effectiveness,” another change from the original complaint.

The intervenors sought declaratory and injunctive relief, including the reinstatement of the drug's 2016 REMS, rescinding the 2019 generic approval, reinstating the in-person dispensing requirement, and holding unlawful the provision of the drug to "adolescent populations." Unlike the original complaint, the amended complaint did not challenge mifepristone's original approve or argue that mifepristone and misoprostol fall outside the scope of FDA's regulation.

On November 1, defendants filed a motion to dismiss, requesting that both plaintiff and the intervenor states’ complaints be dismissed or, in the alternative, that plaintiffs’ complaint be dismissed and intervenor states’ complaint be transferred to a district where venue would be proper.

	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 61474
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 3033177
23-10362	Order U.S. Court of Appeals for the Fifth Circuit	Aug. 16, 2023	Aug. 16, 2023 Order/Opinion 78 F.4th 210
23-00235	Supreme Court of the United States Opinion FDA, et al. v. Alliance for Hippocratic Medicine, et al. Supreme Court of the United States	June 13, 2024	June 13, 2024 Order/Opinion 2024 WL 2964140
195-1 2:22-cv-00223	Amended Complaint State of Missouri v. U.S. Food and Drug Administration	Oct. 11, 2024	Oct. 11, 2024 Complaint

ECF Number	Description	Date	Link Date / Link
1	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) 1 Table of Exhibits View on RECAP 2 Exhibit(s) 1 View on RECAP 3 Exhibit(s) 2 View on RECAP 4 Exhibit(s) 3 View on RECAP 5 Exhibit(s) 4 View on RECAP 6 Exhibit(s) 5 View on RECAP 7 Exhibit(s) 6 View on RECAP 8 Exhibit(s) 7 View on RECAP 9 Exhibit(s) 8 View on RECAP 10 Exhibit(s) 9 View on RECAP 11 Exhibit(s) 10 View on RECAP 12 Exhibit(s) 11 View on RECAP 13 Exhibit(s) 12 View on RECAP 14 Exhibit(s) 13 View on RECAP 15 Exhibit(s) 14 View on RECAP 16 Exhibit(s) 15 View on RECAP 17 Exhibit(s) 16 View on RECAP 18 Exhibit(s) 17 View on RECAP 19 Exhibit(s) 18 View on RECAP 20 Exhibit(s) 19 View on RECAP 21 Exhibit(s) 20 View on RECAP 22 Exhibit(s) 21 View on RECAP 23 Exhibit(s) 22 View on RECAP 24 Exhibit(s) 23 View on RECAP 25 Exhibit(s) 24 View on RECAP 26 Exhibit(s) 25 View on RECAP 27 Exhibit(s) 26 View on RECAP 28 Exhibit(s) 27 View on RECAP 29 Exhibit(s) 28 View on RECAP 30 Exhibit(s) 29 View on RECAP 31 Exhibit(s) 30 View on RECAP 32 Exhibit(s) 31 View on RECAP 33 Exhibit(s) 32 View on RECAP 34 Exhibit(s) 33 View on RECAP 35 Exhibit(s) 34 View on RECAP 36 Exhibit(s) 35 View on RECAP 37 Exhibit(s) 36 View on RECAP 38 Exhibit(s) 37 View on RECAP 39 Exhibit(s) 38 View on RECAP 40 Exhibit(s) 39 View on RECAP 41 Exhibit(s) 40 View on RECAP 42 Exhibit(s) 41 View on RECAP 43 Exhibit(s) 42 View on RECAP 44 Exhibit(s) 43 View on RECAP 45 Exhibit(s) 44 View on RECAP 46 Exhibit(s) 45 View on RECAP 47 Exhibit(s) 46 View on RECAP 48 Exhibit(s) 47 View on RECAP 49 Exhibit(s) 48 View on RECAP 50 Exhibit(s) 49 View on RECAP 51 Exhibit(s) 50 View on RECAP 52 Exhibit(s) 51 View on RECAP 53 Exhibit(s) 52 View on RECAP 54 Cover Sheet View on RECAP	Nov. 18, 2022	Nov. 18, 2022 Clearinghouse
2	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 RECAP
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) 1 Summons for Robert M. Califf View on RECAP 2 Summons for Janet Woodcock View on RECAP 3 Summons for Patrizia Cavazzoni View on RECAP 4 Summons for U.S. Department of Health and Human Services View on RECAP 5 Summons for Xavier Becerra View on RECAP 6 Summons for US Attorney Chad Meacham View on RECAP 7 Summons for USAG Merrick Garland View on RECAP	Nov. 18, 2022	Nov. 18, 2022 RECAP
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 RECAP
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 RECAP
6	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 View on RECAP	Nov. 18, 2022	Nov. 18, 2022 RECAP
7	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 RECAP
8	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) 1 Appendix pt. 2 View on RECAP 2 Appendix pt. 3 View on RECAP 3 Appendix pt. 4 View on RECAP	Nov. 18, 2022	Nov. 18, 2022 RECAP
9	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) 1 Proposed Order View on RECAP 2 Payment Receipt View on RECAP	Nov. 30, 2022	Nov. 30, 2022 RECAP
10	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 RECAP
11	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 RECAP
12	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 View on RECAP	Dec. 2, 2022	Dec. 2, 2022 RECAP
13	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 RECAP
14	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) 1 Proposed Order View on RECAP	Dec. 27, 2022	Dec. 27, 2022 RECAP
15	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 RECAP
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 (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) 1 Additional Page(s) Certificates of Good Standing View on RECAP	Jan. 9, 2023	Jan. 9, 2023 RECAP
17	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 RECAP
18	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 View on RECAP	Jan. 9, 2023	Jan. 9, 2023 RECAP
19	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 View on RECAP 2 Exhibit(s) Exhibit 2 - Appendix View on RECAP 3 Proposed Order Proposed Order View on RECAP	Jan. 13, 2023	Jan. 13, 2023 RECAP
20	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 RECAP
21	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 RECAP
22	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) 1 Proposed Order Proposed Order View on RECAP	Jan. 13, 2023	Jan. 13, 2023 RECAP
23	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) 1 Proposed Order View on RECAP	Jan. 13, 2023	Jan. 13, 2023 RECAP
24	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) 1 Proposed Order View on RECAP	Jan. 13, 2023	Jan. 13, 2023 RECAP
25	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) 1 Proposed Order View on RECAP	Jan. 13, 2023	Jan. 13, 2023 RECAP
26	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) 1 Proposed Order View on RECAP	Jan. 13, 2023	Jan. 13, 2023 RECAP
27	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) 1 Proposed Order View on RECAP	Jan. 13, 2023	Jan. 13, 2023 RECAP
28	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 View on RECAP 2 Exhibit(s) Lindo View on RECAP 3 Exhibit(s) Ireland View on RECAP 4 Exhibit(s) Kieltyka View on RECAP 5 Exhibit(s) Zite View on RECAP 6 Exhibit(s) Glaser View on RECAP 7 Exhibit(s) McHugh View on RECAP	Jan. 13, 2023	Jan. 13, 2023 RECAP
29	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 RECAP
30	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 RECAP
31	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 RECAP
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 RECAP
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 RECAP
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 RECAP
35	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 RECAP
36	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 RECAP
37	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 RECAP
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 RECAP
39	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 RECAP
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 View on RECAP	Feb. 9, 2023	Feb. 9, 2023 RECAP

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

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