Farmakeio Outsourcing, LLC v. United States Food and Drug Administration et al
| Farmakeio Outsourcing, LLC |
| Dr. Robert M Califf and United States Food and Drug Administration |
| 4:2024cv01040 |
| October 25, 2024 |
| U.S. District Court for the Northern District of Texas |
| Reed C O'Connor |
| Other Statutes: Administrative Procedure Act/Review or Appeal of Agency Decision |
| 05 U.S.C. § 702 Administrative Procedure Act |
| None |
Docket Report
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This docket was last retrieved on March 5, 2026. A more recent docket listing may be available from PACER.
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Filing 28
ELECTRONIC ORDER granting #27 Application for Admission Pro Hac Vice of Lee H. Rosebush. 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 Reed C. O'Connor on 12/23/2024) (chmb)(MRF)
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Filing 27
Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Lee H. Rosebush (Filing fee $100; Receipt number ATXNDC-15143139) filed by Farmakeio Outsourcing, LLC (Attachments: #1 Exhibit(s), #2 Proposed Order) (Doyle, Tyler)
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Filing 26
NOTICE of Attorney Appearance by James W Harlow on behalf of United States Food and Drug Administration, Robert M Califf. (Filer confirms contact info in ECF is current.) (Harlow, James)
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Deadline Modification: Deadlines set and reset. Replies due by 7/16/2025 Per Order #20 . (wxc)
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Filing 25
ELECTRONIC ORDER granting #16 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). (Ordered by Judge Reed C. O'Connor on 11/21/2024) (chmb)(MRF)
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Filing 24
ELECTRONIC ORDER granting #15 Application for Admission Pro Hac Vice of Renee M. Knudsen. 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 Reed C. O'Connor on 11/21/2024) (chmb)(MRF)
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Filing 23
ELECTRONIC ORDER granting #14 Application for Admission Pro Hac Vice of Andrew M. Grossman. 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 Reed C. O'Connor on 11/21/2024) (chmb)(MRF)
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Filing 22
ELECTRONIC ORDER granting #13 Application for Admission Pro Hac Vice of Marc N. Wagner. 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 Reed C. O'Connor on 11/21/2024) (chmb)(MRF)
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Deadline Modification: Responses due by 5/1/2025. Replies due by 6/16/2025. Per Order #20 . (wxc)
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Filing 21
ORDER granting #19 : Based on his active status in the Northern District, familiarity with the Local Rules, and commitment to appear for any in-person hearings, the Court GRANTS leave to proceed as local counsel. (Ordered by Judge Reed C. O'Connor on 11/20/2024) (wxc)
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Filing 20
ORDER GRANTING JOINT MOTION TO SET A SUMMARY JUDGMENT BRIEFING SCHEDULE AND TO STAY DEFENDANTS' DEADLINE TO RESPOND TO THE COMPLAINT #18 : Having considered the Parties' Joint Motion to Set a Summary Judgment Briefing Schedule and to Stay Defendants Deadline to Respond to the Complaint, and for good cause shown, the Court hereby enters the following briefing schedule (see order for further specifics) (Ordered by Judge Reed C. O'Connor on 11/20/2024) (wxc)
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Filing 19
MOTION (Unopposed) for Leave to Proceed Without Local Counsel filed by Farmakeio Outsourcing, LLC (Attachments: #1 Proposed Order) (Doyle, Tyler)
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Filing 18
Joint MOTION to Extend Time Answer and Summary Judgment filed by United States Food and Drug Administration, Robert M Califf with Brief/Memorandum in Support. (Attachments: #1 Proposed Order) (Charles, Amber)
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Filing 17
NOTICE of Attorney Appearance by Amber Michelle Charles on behalf of United States Food and Drug Administration, Robert M Califf. (Filer confirms contact info in ECF is current.) (Charles, Amber)
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Filing 16
Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Richard B. Raile (Filing fee $100; Receipt number ATXNDC-15073080) filed by Farmakeio Outsourcing, LLC (Attachments: #1 Proposed Order, #2 List of Additional Courts, #3 Certificate of Good Standing) (Doyle, Tyler)
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Filing 15
Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Renee M. Knudsen (Filing fee $100; Receipt number ATXNDC-15072921) filed by Farmakeio Outsourcing, LLC (Attachments: #1 Proposed Order, #2 List of Additional Courts, #3 Certificate of Good Standing) (Doyle, Tyler)
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Filing 14
Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Andrew M. Grossman (Filing fee $100; Receipt number ATXNDC-15072893) filed by Farmakeio Outsourcing, LLC (Attachments: #1 Proposed Order, #2 List of Additional Courts, #3 Certificate of Good Standing) (Doyle, Tyler)
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Filing 13
Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Marc N. Wagner (Filing fee $100; Receipt number ATXNDC-15072667) filed by Farmakeio Outsourcing, LLC (Attachments: #1 Proposed Order, #2 Certificate of Good Standing) (Doyle, Tyler)
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Filing 12
SUMMONS Returned Executed as to AUSA on 10/29/2024. (Doyle, Tyler) Modified on 11/4/2024 (sre).
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Filing 11
SUMMONS Returned Executed as to Robert M Califf ; served on 10/29/2024. (Doyle, Tyler)
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Filing 10
SUMMONS Returned Executed as to United States Food and Drug Administration ; served on 10/29/2024. (Doyle, Tyler)
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Filing 9
SUMMONS Returned Executed as to United States Food and Drug Administration ; served on 10/30/2024. (Doyle, Tyler)
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Filing 8
CERTIFICATE OF INTERESTED PERSONS/DISCLOSURE STATEMENT by Farmakeio Outsourcing, LLC. (Clerk QC note: Affiliate entry indicated). (Doyle, Tyler)
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Filing 7
Request for Clerk to issue Summons to United States Attorney (NDTX) filed by Farmakeio Outsourcing, LLC. (Doyle, Tyler)
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Filing 6
Summons issued as to Robert M Califf, United States Food and Drug Administration, U.S. Attorney, and U.S. Attorney General. (sre)
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Filing 5
Request for Clerk to issue Summons to United States Attorney General filed by Farmakeio Outsourcing, LLC. (Doyle, Tyler)
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Filing 4
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. (sre)
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Filing 3
Request for Clerk to issue Summons to Dr. Robert M. Califf filed by Farmakeio Outsourcing, LLC. (Doyle, Tyler)
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Filing 2
Request for Clerk to issue Summons to United States Food and Drug Administration filed by Farmakeio Outsourcing, LLC. (Doyle, Tyler)
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Filing 1
COMPLAINT against Robert M Califf, United States Food and Drug Administration filed by Farmakeio Outsourcing, LLC. (Filing fee $405; Receipt number ATXNDC-15018402) 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)
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