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Case TitlePublic Health and Medical Professionals for Transparency et al v. Food and Drug Administration
DistrictNorthern District of Texas
CityFort Worth
Case Number4:2022cv00915
Date Filed2022-10-11
Date ClosedOpen
JudgeJudge Mark Pittman
PlaintiffPublic Health and Medical Professionals for Transparency
PlaintiffPatrick de Garay
PlaintiffStephanie de Garay
Case DescriptionPublic Health and Medical Professionals for Transparency submitted two FOIA requests to the FDA for records concerning the COVID-19 vaccines. The agency acknowledged receipt of the requests. After the agency failed to respond, PHMPT filed suit, asking the court to require the FDA to disclose records at a rate of 55,000 pages a month.
Complaint issues: Failure to respond within statutory time limit, Litigation - Attorney's fees

DefendantFood and Drug Administration
Documents
Docket
Complaint
Complaint attachment 1
Complaint attachment 2
Complaint attachment 3
Complaint attachment 4
Complaint attachment 5
Complaint attachment 6
Complaint attachment 7
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Complaint attachment 9
Complaint attachment 10
User-contributed Documents
 
Docket Events (Hide)
Date FiledDoc #Docket Text

2022-10-111COMPLAINT against Food and Drug Administration filed by Stephanie de Garay, Patrick de Garay, Public Health and Medical Professionals for Transparency. (Filing fee $402; Receipt number ATXNDC-13217227) Clerk to issue summons(es) for federal defendant(s). 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 Exhibit(s) PHMPT's FOIA Request for Moderna BLA File, # 2 Exhibit(s) PHMPT Denial Letter for Expedited Processing, # 3 Exhibit(s) PHMPT Expedited Processing Appeal, # 4 Exhibit(s) PHMPT Appeal Acknowledgement, # 5 Exhibit(s) PHMPT's FOIA Request for Pfizer 12-15 BLA File, # 6 Exhibit(s) PHMPT Expedited Processing Denied, # 7 Exhibit(s) de Garay's FOIA Request for Pfizer 12-15 BLA File (Redacted), # 8 Exhibit(s) de Garay's Expedited Processing Denied, # 9 Cover Sheet Civil Cover Sheet, # 10 Declaration(s) Rule 7.1 Declaration) (Moller, Walker) (Entered: 10/11/2022)
2022-10-112Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Aaron Siri (Filing fee $100; Receipt number ATXNDC-13217273) filed by Public Health and Medical Professionals for Transparency, Patrick de Garay, Stephanie de Garay (Moller, Walker) (Entered: 10/11/2022)
2022-10-113Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Elizabeth A. Brehm (Filing fee $100; Receipt number ATXNDC-13217278) filed by Public Health and Medical Professionals for Transparency, Patrick de Garay, Stephanie de Garay (Moller, Walker) (Entered: 10/11/2022)
2022-10-114Application for Admission Pro Hac Vice with Certificate of Good Standing for Attorney Colin M. Farnsworth (Filing fee $100; Receipt number ATXNDC-13217284) filed by Public Health and Medical Professionals for Transparency, Patrick de Garay, Stephanie de Garay (Moller, Walker) (Entered: 10/11/2022)
2022-10-115New 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. (fba) (Entered: 10/12/2022)
2022-10-126Summons issued as to Food and Drug Administration, U.S. Attorney, and U.S. Attorney General. (fba) (Entered: 10/12/2022)
2022-10-127CERTIFICATE OF INTERESTED PERSONS/DISCLOSURE STATEMENT by Public Health and Medical Professionals for Transparency, Patrick de Garay, Stephanie de Garay. (Clerk QC note: No affiliate entered in ECF). (Moller, Walker) (Entered: 10/12/2022)
2022-10-138ELECTRONIC ORDER granting 2 Application for Admission Pro Hac Vice of Aaron Siri. 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 10/13/2022) (chmb)(tjp) (Entered: 10/13/2022)
2022-10-139ELECTRONIC ORDER granting 3 Application for Admission Pro Hac Vice of Elizabeth A. Brehm. 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 10/13/2022) (chmb)(tjp) (Entered: 10/13/2022)
2022-10-1310ELECTRONIC ORDER granting 4 Application for Admission Pro Hac Vice of Colin M. Farnsworth. 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 10/13/2022) (chmb)(tjp) (Entered: 10/13/2022)
2022-10-2111MOTION leave to proceed without local counsel filed by Public Health and Medical Professionals for Transparency, Patrick de Garay, Stephanie de Garay (Attachments: # 1 Proposed Order) (Moller, Walker) (Entered: 10/21/2022)
2022-10-3112ORDER denying 11 Plaintiffs' Motion to Proceed Without Local Counsel. Accordingly, Plaintiffs shall file the entry of appearance of local counsel satisfying the requirements of Local Rule 83.10(a) on or before November 11, 2022. (Ordered by Judge Mark Pittman on 10/31/2022). (fba) (Entered: 11/01/2022)
2022-11-0913NOTICE of Attorney Appearance by John Clay Sullivan on behalf of Public Health and Medical Professionals for Transparency, Patrick de Garay, Stephanie de Garay. (Filer confirms contact info in ECF is current.) (Sullivan, John) (Entered: 11/09/2022)
2022-11-1014SUMMONS Returned Executed as to Food and Drug Administration ; served on 11/1/2022. (Brehm, Elizabeth) (Entered: 11/10/2022)
2022-11-2215Unopposed Motion for Extension of Time to File Answer filed by Food and Drug Administration with Brief/Memorandum in Support. Attorney Clayton Ray Mahaffey-DOJ added to party Food and Drug Administration(pty:dft) (Mahaffey-DOJ, Clayton) (Entered: 11/22/2022)
2022-11-2316ORDER granting 15 Motion for Extension of Time to File Answer. Food and Drug Administration answer due 1/6/2023. (Ordered by Judge Mark Pittman on 11/23/2022) (tjc) (Entered: 11/23/2022)
2023-01-0617ANSWER to 1 Complaint,,,,,,, filed by Food and Drug Administration. Unless exempted, attorneys who are not admitted to practice in the Northern District of Texas must seek admission promptly. Forms and Instructions 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. 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. (Mahaffey-DOJ, Clayton) (Entered: 01/06/2023)
2023-01-0618CERTIFICATE OF INTERESTED PERSONS/DISCLOSURE STATEMENT by Food and Drug Administration. (Clerk QC note: No affiliate entered in ECF). (Mahaffey-DOJ, Clayton) (Entered: 01/06/2023)
2023-01-1319ORDER: This Order is being sent to all counsel and unrepresented parties who have appeared. If there are other defendants who have not appeared, but who have been in contact with the plaintiff or plaintiff's counsel, then the plaintiff's counsel (or the plaintiff if the plaintiff is unrepresented) is responsible for contacting such defendants and making every effort to ensure their meaningful participation in the conference. Lead counsel for each party (or designee attorney with appropriate authority) and any unrepresented party (except for a prisoner litigant proceeding pro se) shall confer (the "Scheduling Conference") in a face-to-face conference as soon as practicable. As a result of the Scheduling Conference, counsel shall prepare and submit a Report Regarding Contents of Scheduling Order ("Joint Report"). The Joint Report, which shall be filed on or before January 27, 2023. (Ordered by Judge Mark Pittman on 1/13/2023) (tjc) (Entered: 01/13/2023)
2023-01-2720Joint STATUS REPORT Regarding Scheduling filed by Food and Drug Administration. (Mahaffey-DOJ, Clayton) (Entered: 01/27/2023)
2023-02-0721ORDER: Before the Court is the Parties Joint Scheduling Report. ECF No. 20 . Having considered the Joint Report, related docket entries, and applicable law, the Court hereby ORDERS the Parties to file a joint status report regarding the status of negotiations by February 17, 2023. (Ordered by Judge Mark Pittman on 2/7/2023) (tjc) (Entered: 02/07/2023)
2023-02-1722Joint STATUS REPORT filed by Food and Drug Administration. (Mahaffey-DOJ, Clayton) (Entered: 02/17/2023)
2023-02-2323ORDER: Before the Court is the Parties Joint Status Report. ECF No. 22 . Having considered the Joint Report, related docket entries, and applicable law, the Court hereby ORDERS Plaintiffs to file their opening brief as to the timing for producing responsive records by March 8, 2023, the FDA to file its opposition by March 22, 2023, and Plaintiffs to file their reply by March 29, 2023. (Ordered by Judge Mark Pittman on 2/23/2023) (tjc) (Entered: 02/23/2023)
2023-03-0824Brief/Memorandum in Support filed by Public Health and Medical Professionals for Transparency, Patrick de Garay, Stephanie de Garay re 23 Order Setting Deadline/Hearing, (Siri, Aaron) (Entered: 03/08/2023)
2023-03-1725Unopposed MOTION for Extension of Time to File Response to Brief re: Production Schedule filed by Food and Drug Administration with Brief/Memorandum in Support. (Mahaffey-DOJ, Clayton) (Entered: 03/17/2023)
2023-03-2326ORDER: Before the Court is Defendant's Unopposed Motion for Extension of Time to Respond to Plaintiffs' Brief ("Motion"). ECF No. 25 . Having considered the Motion, the Court concludes that the Motion should be, and it is hereby, GRANTED. (Ordered by Judge Mark Pittman on 3/23/2023) (fba) (Entered: 03/23/2023)
2023-03-3127RESPONSE filed by Food and Drug Administration re: 24 Brief/Memorandum in Support of Motion (Attachments: # 1 Declaration(s), # 2 Declaration(s)) (Mahaffey-DOJ, Clayton) (Entered: 03/31/2023)
2023-04-1228REPLY filed by Public Health and Medical Professionals for Transparency, Patrick de Garay, Stephanie de Garay re 24 Brief/Memorandum in Support filed by Public Health and Medical Professionals for Transparency, Patrick de Garay, Stephanie de Garay re: 23 Order Setting Deadline/Hearing, (Siri, Aaron) Modified on 4/13/2023 to add 24 Brief (dgt). (Entered: 04/12/2023)
2023-04-2129ORDER: The Court sets a thirty-minute status conference on Monday, May 1, 2023, at 2:00 p.m. in the Fourth Floor Courtroom of the Eldon B. Mahon United StatesCourthouse, located at 501 W. 10th Street, Fort Worth, Texas. Counsel for all parties are ORDERED to attend. (Ordered by Judge Mark Pittman on 4/21/2023) (fba) (Entered: 04/21/2023)
2023-05-0130ELECTRONIC Minute Entry for proceedings held before Judge Mark Pittman: Status Conference held on 5/1/2023. Attorney Appearances: Plaintiff - Aaron Siri; Defense - Clayton Ray Mahaffey. (Court Reporter: Monica Guzman) (No exhibits) Time in Court - 1:03. (chmb) (Entered: 05/02/2023)
2023-05-0931ORDER: Because the FDA improperly denied Plaintiffs request, the Court ORDERS the FDA to produce all documents relating to the two vaccines by June 30, 2025. The Court recognizes the burden the FDA faces in releasing the documents by the above mentioned date and thus ORDERS the Parties to meet and confer and submit a joint production rate that maximally reduces this burden by May 23, 2023 (See Order for Specifics). (Ordered by Judge Mark Pittman on 5/9/2023) (tjc) Document replaced on 5/15/2023 per DJ chambers (bdb). Modified docket text on 5/15/2023 (bdb). (Entered: 05/09/2023)
2023-05-1232MOTION to Withdraw as Attorney (Colin M. Farnsworth) filed by Public Health and Medical Professionals for Transparency, Patrick de Garay, Stephanie de Garay (Attachments: # 1 Proposed Order) (Brehm, Elizabeth) (Entered: 05/12/2023)
2023-05-1533ORDER granting 32 Motion to Withdraw. Attorney Colin M. Farnsworth is hereby withdrawn. (Ordered by Judge Mark Pittman on 5/15/2023) (rjh) (Entered: 05/15/2023)
2023-05-1534Notice of Filing of Official Electronic Transcript of Status Conference Proceedings held on May 1, 2023 before Judge Mark T. Pittman. Court Reporter/Transcriber Monica Guzman, Telephone number 817-850-6681 or mguzman.csr@yahoo.com. Parties are notified of their duty to review the transcript. A copy may be purchased from the court reporter or viewed at the clerk's office. If the transcript contains personal identifiers that must be redacted under MO 61, Fed.R.Civ.P. 5.2 or Fed.R.Crim.P. 49.1, or if the transcript contains the name of a minor child victim or a minor child witness that must be redacted under 18 U.S.C. § 3509, file a Redaction Request - Transcript within 21 days. If no action is taken, the entire transcript will be made available through PACER without redaction after 90 calendar days. The clerk will mail a copy of this notice to parties not electronically noticed. (59 pages) Redaction Request due 6/5/2023. Redacted Transcript Deadline set for 6/15/2023. Release of Transcript Restriction set for 8/14/2023. (mwg) (Entered: 05/15/2023)
2023-05-2335Unopposed MOTION for Extension of Time to File Response to Order (Docket 31) filed by Food and Drug Administration (Mahaffey-DOJ, Clayton) (Entered: 05/23/2023)
2023-05-2336ORDER granting 35 Motion for Extension of Time to Respond to Court Order. (Ordered by Judge Mark Pittman on 5/23/2023) (tjc) (Entered: 05/23/2023)
2023-06-0237Joint STATUS REPORT filed by Food and Drug Administration. (Mahaffey-DOJ, Clayton) (Entered: 06/02/2023)
2023-06-1238ORDER: Having considered the Parties proposed production schedules, arguments in support, and applicable law, the Court ORDERS the following: 1. The FDA must produce all documents related to Pfizer's 12 to 15-year-olds COVID-19 vaccine by January 2, 2024; 2. The FDA must produce all documents related to Moderna's adult COVID-19 vaccine by June 30, 2025. The Parties must submit a Joint Status Report detailing the progress of the rolling production by September 1, 2023, and every 90 days thereafter. (See order for specifics). (Ordered by Judge Mark Pittman on 6/12/2023) (fba) (Entered: 06/12/2023)
2023-09-0139Joint STATUS REPORT filed by Food and Drug Administration. (Mahaffey-DOJ, Clayton) (Entered: 09/01/2023)
2023-09-2540Notice of Substitution of Counsel by AUSA. Sarah Elizabeth Delaney-DOJ added as AUSA. (Delaney-DOJ, Sarah) (Entered: 09/25/2023)
2023-11-3041Joint STATUS REPORT filed by Food and Drug Administration. (Delaney-DOJ, Sarah) (Entered: 11/30/2023)
2024-02-2842Joint STATUS REPORT filed by Food and Drug Administration. (Delaney-DOJ, Sarah) (Entered: 02/28/2024)
2024-05-2843Joint STATUS REPORT filed by Food and Drug Administration. (Delaney-DOJ, Sarah) (Entered: 05/28/2024)
2024-08-2644Joint STATUS REPORT filed by Food and Drug Administration. (Delaney-DOJ, Sarah) (Entered: 08/26/2024)
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