Outsourcing Facilities Association et al v. Food and Drug Administration et al
| Outsourcing Facilities Association and North American Custom Laboratories LLC doing business as FarmaKeio Superior Custom Compounding |
| United States Food and Drug Administration and Sara Brenner |
| Novo Nordisk Inc |
| 4:2025cv00174 |
| February 24, 2025 |
| U.S. District Court for the Northern District of Texas |
| Mark Pittman |
| Other Statutes: Administrative Procedure Act/Review or Appeal of Agency Decision |
| 05 U.S.C. § 551 Administrative Procedure Act |
| None |
Docket Report
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This docket was last retrieved on April 24, 2025. A more recent docket listing may be available from PACER.
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Filing 63
(Document Restricted) OPINION & ORDER: Plaintiffs' #36 Motion for Preliminary Injunction and Stay is DENIED. The undersigned finds it appropriate to file this unredacted opinion under seal. It is ORDERED that, on or before 4:00 p.m., April 29, 2025, the Parties shall submit an agreed upon version of the order containing any appropriate redactions. After receiving and reviewing the Parties' version, the Court will issue the redacted order. (Ordered by Judge Mark Pittman on 4/24/2025) (saw)
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| Filing 62 REPLY filed by North American Custom Laboratories LLC, Outsourcing Facilities Association re: #36 MOTION for Injunction (Doyle, Tyler) |
| Filing 61 (Document Restricted) Sealed Appendix in Support re: #60 Sealed and/or Ex Parte Reply/Sur-reply (Sealed pursuant to order dated 3/6/2025) (Attachments: #1 Additional Page(s) Supp. App. Vol II of IV, #2 Additional Page(s) Supp. App. Vol III of IV, #3 Additional Page(s) Supp. App. Vol IV of IV) (Doyle, Tyler) |
| Filing 60 (Document Restricted) Sealed Reply re: #36 Motion for Injunction (Sealed pursuant to order dated 3/6/2025) (Doyle, Tyler) |
| Filing 59 NOTICE of Attorney Appearance by Marc N Wagner on behalf of North American Custom Laboratories LLC, Outsourcing Facilities Association. (Filer confirms contact info in ECF is current.) (Wagner, Marc) |
| Filing 58 NOTICE of Attorney Appearance by Andrew Michael Grossman on behalf of North American Custom Laboratories LLC, Outsourcing Facilities Association. (Filer confirms contact info in ECF is current.) (Grossman, Andrew) |
| Filing 57 NOTICE of Attorney Appearance by Richard Bryan Raile on behalf of North American Custom Laboratories LLC, Outsourcing Facilities Association. (Filer confirms contact info in ECF is current.) (Raile, Richard) |
| Filing 56 RESPONSE filed by Sara Brenner, United States Food and Drug Administration re: #36 MOTION for Injunction (McDonald, Oliver) |
| Filing 55 NOTICE of Letter to Judge Pittman re: 43 Order on Application for Admission Pro Hac Vice,, #40 Order Setting Deadline/Hearing,, filed by North American Custom Laboratories LLC, Outsourcing Facilities Association (Doyle, Tyler) |
| Filing 54 RESPONSE filed by Novo Nordisk Inc re: #36 MOTION for Injunction (Carolan, Trevor) |
| Filing 53 (Document Restricted) Sealed Response re: #36 Motion for Injunction (Sealed pursuant to order dated 3/6/2025) filed by Novo Nordisk Inc (Carolan, Trevor) |
| Filing 52 (Document Restricted) Sealed Appendix in Support re: #51 Sealed and/or Ex Parte Response/Objection (Sealed pursuant to order dated 3/6/2025) filed by Sara Brenner, United States Food and Drug Administration (Attachments: #1 Additional Page(s)) (McDonald, Oliver) |
| Filing 51 (Document Restricted) Sealed Response re: #36 Motion for Injunction (Sealed pursuant to order dated 3/6/2025) filed by Sara Brenner, United States Food and Drug Administration (McDonald, Oliver) |
| Filing 50 NOTICE of Attorney Appearance by David Hixson on behalf of Sara Brenner, United States Food and Drug Administration. (Filer confirms contact info in ECF is current.) (Hixson, David) |
| Filing 49 (Document Restricted) Administrative Record (Sealed pursuant to order dated 3/6/2025) filed by Sara Brenner, United States Food and Drug Administration (Attachments: #1 Additional Page(s) Certified Index of AR, #2 Additional Page(s) AR 1-563, #3 Additional Page(s) AR 564-976, #4 Additional Page(s) AR 977-1302, #5 Additional Page(s) AR 1303-2859, #6 Additional Page(s) AR 2860-3061) (McDonald, Oliver) |
| Filing 48 Amicus Curiae Brief in Support filed by NP 2 Go Inc re #36 MOTION for Injunction (saw) (Main Document 48 replaced on 4/4/2025) (saw). Amicus Curiae Brief in Support filed by NP 2 Go Inc re #36 MOTION for Injunction (saw) (Main Document 48 replaced on 4/4/2025) (saw). |
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Filing 47
ELECTRONIC ORDER granting #44 NP 2 Go, Inc.'s Unopposed Motion for Leave to File Brief of Amicus Curiae. (Unless the document has already been filed, clerk to enter the document as of the date of this order.) (Ordered by Judge Mark Pittman on 4/4/2025) (chmb)
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Filing 46
ELECTRONIC ORDER granting #45 Application for Admission Pro Hac Vice of Julia Cantu. 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 Mark Pittman on 4/4/2025) (chmb)
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| Filing 45 Application for Admission Pro Hac Vice with Certificate of Good Standing (Filing fee $100; Receipt number ATXNDC-15396109) filed by NP 2 Go Inc (Attachments: #1 Additional Page(s) Certificate of Good Standing (TX)) (Cantu, Julia) |
| Filing 44 Unopposed MOTION for Leave to File Brief of Amicus Curiae in support of Plaintiffs' motion for preliminary injunction filed by NP 2 Go, Inc. with Brief/Memorandum in Support. (Attachments: #1 Proposed Order Proposed Order, #2 Exhibit(s) Exhibit A - Amicus Curiae Brief). Party NP 2 Go, Inc. added.Attorney Julia Christine Cantu added to party NP 2 Go, Inc. (pty:am) (Cantu, Julia) |
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Filing 43
ELECTRONIC ORDER granting #41 Application for Admission Pro Hac Vice of Richard B. Raile. 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). Additionally, in ECF No. 42, Plaintiffs' counsel requests additional time to comply with the Court's order. That request is GRANTED and the deadline imposed in ECF No. 40 is hereby extended to April 18, 2025. (Ordered by Judge Mark Pittman on 3/27/2025) (chmb)
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| Filing 42 RESPONSE filed by Outsourcing Facilities Association re: #40 Order Setting Deadline/Hearing,, (Kustoff, Jeremy) |
| Filing 41 Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Richard B. Raile (Clerk Note: ATXNDC-15374690; Filing Fee $100.00) filed by Outsourcing Facilities Association (Kustoff, Jeremy) Modified filing fee on 3/28/2025 (saw). |
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Filing 40
ORDER: It is ORDERED that Mr. Wagner and Mr. Grossman shall on or before April 4, 2025, either get admitted to the bar of this Court or withdraw from this matter. Failure to comply will result in the imposition of sanctions, including the striking of Plaintiff's filings. The Court ORDERS Mr. Raile to file an application to proceed pro hac vice or otherwise comply with Local Rule 83.9(a) on or before April 4, 2025. Failure to do so may result in the imposition of sanctions, including the striking of Plaintiff's filings. (Ordered by Judge Mark Pittman on 3/26/2025) (saw)
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| Filing 39 Appendix in Support filed by North American Custom Laboratories, LLC, Outsourcing Facilities Association re #36 MOTION for Injunction (Attachments: #1 Additional Page(s) App. Vol. II) (Doyle, Tyler) |
| Filing 38 Brief/Memorandum in Support filed by North American Custom Laboratories, LLC, Outsourcing Facilities Association re #36 MOTION for Injunction (Doyle, Tyler) |
| Filing 37 (Document Restricted) Sealed Brief/Memorandum in Support re: #36 Motion for Injunction (Sealed pursuant to order dated 3/6/2025) filed by North American Custom Laboratories, LLC, Outsourcing Facilities Association (Attachments: #1 Exhibit(s) Sealed FDA Decision Memo) (Doyle, Tyler) |
| Filing 36 MOTION for Injunction filed by North American Custom Laboratories, LLC, Outsourcing Facilities Association (Attachments: #1 Proposed Order) (Doyle, Tyler) |
| Filing 35 SUMMONS Returned Executed as to Sara Brenner ; served on 3/7/2025; United States Food and Drug Administration ; served on 3/7/2025. (Attachments: #1 Affidavit(s) Brenner, #2 Affidavit(s) FDA AG, #3 Affidavit(s) FDA NDTX, #4 Affidavit(s) Brenner AG, #5 Affidavit(s) Brenner NDTX) (Doyle, Tyler) |
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Filing 34
ELECTRONIC ORDER granting #33 Application for Admission Pro Hac Vice of Kristin Shapiro. 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 Mark Pittman on 3/11/2025) (chmb)
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| Filing 33 Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Kristin Shapiro (Filing fee $100; Receipt number ATXNDC-15330599) filed by North American Custom Laboratories, LLC, Outsourcing Facilities Association (Attachments: #1 Proposed Order, #2 Exhibit(s) Additional Courts, #3 Exhibit(s) Certificate of Good Standing) (Doyle, Tyler) |
| Filing 32 NOTICE of Motion Schedule (Joint) re: #30 Order on Motion for Extension of Time filed by Sara Brenner, United States Food and Drug Administration (McDonald, Oliver) |
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Filing 31
STIPULAED PROTECTIVE ORDER: This #29 Stipulated Protective Order ("Protective Order" or "Order") is agreed to this 6th day of March, 2025, by the parties in the above-captioned case (the "Action"). (Ordered by Judge Mark Pittman on 3/6/2025) (saw)
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Filing 30
ORDER: Before the Court is the Parties' Joint Motion to Enter Scheduling Order. ECF No. #28 . Having reviewed the Motion, it is hereby GRANTED. (See order for specifics.) (Ordered by Judge Mark Pittman on 3/6/2025) (saw)
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| Filing 29 Joint MOTION for Protective Order filed by Sara Brenner, United States Food and Drug Administration (Attachments: #1 Proposed Order) (McDonald, Oliver) |
| Filing 28 Joint MOTION to Extend Time to File Answer and to Enter Scheduling Order filed by Sara Brenner, United States Food and Drug Administration (Attachments: #1 Proposed Order) (McDonald, Oliver) |
| Filing 27 NOTICE of Attorney Appearance by Kimberly Ruthsatz Stephens on behalf of Sara Brenner, United States Food and Drug Administration. (Filer confirms contact info in ECF is current.) (Stephens, Kimberly) |
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Filing 26
ORDER: Before the Court is Novo Nordisk Inc.'s Unopposed Motion to Intervene. ECF No. 24. The Court, finding that good cause exists for Novo Nordisks intervention in this case under Federal Rule of Civil Procedure 24, hereby GRANTS Novo Nordisk's Motion to Intervene. It is hereby ORDERED that Defendants' deadline to respond to the complaint is extended until after the Court has ruled on the Parties' summary judgment motions. (Ordered by Judge Mark Pittman on 3/5/2025) (saw)
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| Filing 25 Brief/Memorandum in Support filed by Novo Nordisk Inc. re #24 Unopposed MOTION to Intervene (Renewed) (Carolan, Trevor) |
| Filing 24 Unopposed MOTION to Intervene (Renewed) filed by Novo Nordisk Inc. (Attachments: #1 Proposed Order) (Carolan, Trevor) |
| Filing 23 NOTICE of Attorney Appearance by Oliver McDonald on behalf of Sara Brenner, United States Food and Drug Administration. (Filer confirms contact info in ECF is current.) (McDonald, Oliver) |
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Filing 22
ORDER: Before the Court is Novo Nordisk Inc.'s Unopposed Motion to Intervene. ECF No. #12 . This Motion is premature and is DENIED without prejudice. (Ordered by Judge Mark Pittman on 3/4/2025) (saw)
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Filing 21
ELECTRONIC ORDER granting #18 Application for Admission Pro Hac Vice of Daniel G. Randolph. 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 Mark Pittman on 3/4/2025) (chmb)
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Filing 20
ELECTRONIC ORDER granting #17 Application for Admission Pro Hac Vice of Thomas Brugato. 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 Mark Pittman on 3/4/2025) (chmb)
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Filing 19
ELECTRONIC ORDER granting #15 Application for Admission Pro Hac Vice of Benjamin C. Block. 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 Mark Pittman on 3/4/2025) (chmb)
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| Filing 18 Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Daniel G. Randolph (Filing fee $100; Receipt number ATXNDC-15309884) filed by Novo Nordisk Inc. (Attachments: #1 Proposed Order) (Carolan, Trevor) |
| Filing 17 Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Thomas Brugato (Filing fee $100; Receipt number ATXNDC-15309882) filed by Novo Nordisk Inc. (Attachments: #1 Proposed Order) (Carolan, Trevor) |
| Filing 16 ADDITIONAL ATTACHMENTS to #15 Application for Admission Pro Hac Vice by Intervenor Novo Nordisk Inc.. (Attachments: #1 Proposed Order) (Carolan, Trevor) |
| Filing 15 Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Benjamin C. Block (Filing fee $100; Receipt number ATXNDC-15309837) filed by Novo Nordisk Inc. (Carolan, Trevor) |
| Filing 14 CERTIFICATE OF INTERESTED PERSONS/DISCLOSURE STATEMENT by Novo Nordisk Inc.. (Clerk QC note: Affiliate entry indicated). (Carolan, Trevor) |
| Filing 13 Brief/Memorandum in Support filed by Novo Nordisk Inc. re #12 Unopposed MOTION to Intervene (Carolan, Trevor) |
| Filing 12 Unopposed MOTION to Intervene filed by Novo Nordisk Inc. (Attachments: #1 Proposed Order). Party Novo Nordisk Inc. added.Attorney Trevor William Carolan added to party Novo Nordisk Inc.(pty:intv) (Carolan, Trevor) |
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Filing 11
ORDER: The applications for admission pro hac vice (ECF Nos. #8 , #9 ) should be, and hereby are, DENIED. The Court encourages Mr. Grossman and Mr. Wagner to file applications to be admitted to practice in this Court and would happily welcome them as members of the bar. (Ordered by Judge Mark Pittman on 3/3/2025) (saw)
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| Filing 9 Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Marc N. Wagner (Filing fee $100; Receipt number ATXNDC-15299509) filed by North American Custom Laboratories, LLC, Outsourcing Facilities Association (Attachments: #1 Proposed Order, #2 Exhibit(s) Exhibit A - Certificate of Good Standing) (Doyle, Tyler) |
| Filing 8 Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Andrew M. Grossman (Filing fee $100; Receipt number ATXNDC-15296310) filed by North American Custom Laboratories, LLC, Outsourcing Facilities Association (Attachments: #1 Proposed Order, #2 Exhibit(s) Exhibit A - Additional Courts, #3 Exhibit(s) Exhibit B - Certificate of Good Standing) (Doyle, Tyler) |
| Filing 10 New Case Notes: A filing fee has been paid. File to: Judge Pittman. Pursuant to Misc. Order 6, Plaintiff is provided the Notice of Right to Consent to Proceed Before A U.S. Magistrate Judge. Clerk to provide copy to plaintiff if not received electronically. Attorneys are further reminded that, if necessary, they must comply with Local Rule 83.10(a) within 14 days or risk the possible dismissal of this case without prejudice or without further notice. (saw) |
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Filing 7
ORDER OF TRANSFER: The Court ORDERS that this case be REASSIGNED to Judge Pittman for future case management. Accordingly, the Court DIRECTS the Clerk of Court to update the docket sheet to reflect reassignment of this case to Judge Pittman. All further documents filed in this case SHALL be filed under civil action number 4:25-cv-00174-P. Case reassigned to Judge Mark Pittman for all further proceedings. Judge Reed C. O'Connor no longer assigned to case. (Ordered by Judge Reed C. O'Connor on 2/24/2025) (saw)
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| Filing 6 Summons issued as to Sara Brenner, United States Food and Drug Administration, U.S. Attorney, and U.S. Attorney General. (saw) |
| Filing 5 New Case Notes: A filing fee has been paid. File to: Judge O Connor. Pursuant to Misc. Order 6, Plaintiff is provided the Notice of Right to Consent to Proceed Before A U.S. Magistrate Judge. Clerk to provide copy to plaintiff if not received electronically. Attorneys are further reminded that, if necessary, they must comply with Local Rule 83.10(a) within 14 days or risk the possible dismissal of this case without prejudice or without further notice. (saw) |
| Filing 4 CERTIFICATE OF INTERESTED PERSONS/DISCLOSURE STATEMENT by North American Custom Laboratories, Outsourcing Facilities Association. (Clerk QC note: Affiliate entry indicated). (Doyle, Tyler) |
| Filing 3 Request for Clerk to issue Summons to Sara Brenner filed by North American Custom Laboratories, Outsourcing Facilities Association. (Doyle, Tyler) |
| Filing 2 Request for Clerk to issue Summons to United States Food and Drug Administration filed by North American Custom Laboratories, Outsourcing Facilities Association. (Doyle, Tyler) |
| Filing 1 COMPLAINT against All Defendants filed by North American Custom Laboratories, Outsourcing Facilities Association. (Filing fee $405; receipt number ATXNDC-15288698 ) 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 Cover Sheet) (Doyle, Tyler) Modified docket text on 2/24/2025 (saw). |
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