| Date Filed | Doc # | Docket Text |
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| 2023-01-26 | 1 | COMPLAINT against FOOD AND DRUG ADMINISTRATION ( Filing fee $ 402 receipt number ADCDC-9814037) filed by Children's Health Defense. (Attachments: # 1 Exhibit, # 2 Civil Cover Sheet, # 3 Summons as to FDA, # 4 Summons as to Attorney General, # 5 Summons as to U.S. Attorney's Office)(Flores, Ray) (Entered: 01/26/2023) |
| 2023-01-26 | 2 | LCvR 26.1 CERTIFICATE OF DISCLOSURE of Corporate Affiliations and Financial Interests by Children's Health Defense (Flores, Ray) (Entered: 01/26/2023) |
| 2023-01-26 | | Case Assigned to Judge Randolph D. Moss. (zsl) (Entered: 01/26/2023) |
| 2023-01-26 | 3 | SUMMONS (3) Issued Electronically as to FOOD AND DRUG ADMINISTRATION, U.S. Attorney and U.S. Attorney General (Attachment: # 1 Notice and Consent)(zsl) (Entered: 01/26/2023) |
| 2023-01-26 | 4 | STANDING ORDER: The parties are hereby ORDERED to comply with the directives set forth in the attached Standing Order. See document for details. Signed by Judge Randolph D. Moss on 1/26/2023. (lcrdm1) (Entered: 01/26/2023) |
| 2023-01-31 | 5 | RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed on United States Attorney General. Date of Service Upon United States Attorney General 01/31/2023. (Flores, Ray) (Entered: 01/31/2023) |
| 2023-01-31 | 6 | RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed as to the United States Attorney. Date of Service Upon United States Attorney on 1/31/2023. Answer due for ALL FEDERAL DEFENDANTS by 3/2/2023. (Flores, Ray) (Entered: 01/31/2023) |
| 2023-01-31 | 7 | RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed. FOOD AND DRUG ADMINISTRATION served on 1/30/2023 (Flores, Ray) (Entered: 01/31/2023) |
| 2023-02-21 | 8 | NOTICE OF RELATED CASE by CHILDREN'S HEALTH DEFENSE. Case related to Case No. 1:23-cv-00219-RBW. (Flores, Ray) (Entered: 02/21/2023) |
| 2023-02-21 | 9 | NOTICE of Appearance by Kenneth A. Adebonojo on behalf of FOOD AND DRUG ADMINISTRATION (Adebonojo, Kenneth) (Entered: 02/21/2023) |
| 2023-03-02 | 10 | Consent MOTION for Extension of Time to Respond by FOOD AND DRUG ADMINISTRATION. (Adebonojo, Kenneth) (Entered: 03/02/2023) |
| 2023-03-03 | | MINUTE ORDER: Upon consideration of Defendant's consent motion for extension of time, Dkt. 10 , it is hereby ORDERED that the motion is GRANTED. It is further ORDERED that Defendant shall respond to the complaint on or before April 4, 2023. Signed by Judge Randolph D. Moss on 3/3/2023. (lcrdm1) (Entered: 03/03/2023) |
| 2023-04-04 | 11 | ANSWER to Complaint by UNITED STATES FOOD AND DRUG ADMINISTRATION.(Adebonojo, Kenneth) (Entered: 04/04/2023) |
| 2023-04-05 | | MINUTE ORDER: It is ORDERED that, on or before May 12, 2023, the parties shall confer and file a joint status report addressing (1) any documents still to be produced pursuant to FOIA; (2) an anticipated schedule for processing and producing any such documents; and (3) any substantive areas of disagreement between the parties. It is further ORDERED that the parties shall appear by video for an Initial Scheduling Conference to be held via Zoom on May 19, 2023, at 3:30 p.m. Signed by Judge Randolph D. Moss on 4/5/2023. (lcrdm1) (Entered: 04/05/2023) |
| 2023-04-21 | 12 | NOTICE of Appearance by Risa Evans on behalf of CHILDREN'S HEALTH DEFENSE (Evans, Risa) (Entered: 04/21/2023) |
| 2023-05-12 | 13 | Joint STATUS REPORT by CHILDREN'S HEALTH DEFENSE. (Attachments: # 1 Text of Proposed Order)(Flores, Ray) (Entered: 05/12/2023) |
| 2023-05-14 | | MINUTE ORDER: Upon consideration of the parties' joint status report, Dkt. 13 , it is hereby ORDERED that the parties shall file a further joint status report on or before June 27, 2023. It is further ORDERED that the scheduling conference currently scheduled for May 19, 2023, is VACATED and RESCHEDULED for July 7, 2023, at 10:30 a.m., via Zoom. Signed by Judge Randolph D. Moss on 5/14/2023. (lcrdm1) (Entered: 05/14/2023) |
| 2023-05-14 | | Set/Reset Hearings: Scheduling Conference reset for 5/19/2023 at 10:30 AM in before Judge Randolph D. Moss via Zoom. (zglw) (Entered: 05/15/2023) |
| 2023-05-15 | | Set/Reset Hearings: Scheduling Conference reset for 7/7/2023 at 10:30 AM before Judge Randolph D. Moss via Zoom. (zglw) (Entered: 05/15/2023) |
| 2023-06-27 | 14 | Joint STATUS REPORT by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Adebonojo, Kenneth) (Entered: 06/27/2023) |
| 2023-07-03 | | MINUTE ORDER: Upon consideration of the parties' joint status report, Dkt. 14 , it is hereby ORDERED that the parties shall file a further joint status report on or before August 11, 2023. It is further ORDERED that the Initial Scheduling Conference currently scheduled for July 7, 2023, is VACATED. Signed by Judge Randolph D. Moss on 7/3/2023. (lcrdm1) (Entered: 07/03/2023) |
| 2023-08-11 | 15 | Joint STATUS REPORT by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Adebonojo, Kenneth) (Entered: 08/11/2023) |
| 2023-08-11 | | MINUTE ORDER: Upon consideration of the parties' joint status report, [Dkt. 15], it is hereby ORDERED that the parties shall appear for a Status Conference to be held on August 25, 2023, at 11:30 a.m. via Zoom. Signed by Judge Randolph D. Moss on 8/11/2023. (lcrdm1) (Entered: 08/11/2023) |
| 2023-08-25 | | Minute Entry for proceedings held before Judge Randolph D. Moss: Status Conference held on 8/25/2023 via Zoom. For the reason stated on the record, the defendant shall file a Motion to Stay on or before 9/11/2023. Plaintiff's response is due on or before 9/25/2023 and Defendant's reply is due on or before 10/9/2023. (Court Reporter Tammy Sefranek) (zglw) (Entered: 08/28/2023) |
| 2023-09-08 | 16 | Consent MOTION for Extension of Time to File Defendant's Motion to Stay by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Adebonojo, Kenneth) (Entered: 09/08/2023) |
| 2023-09-09 | | MINUTE ORDER: Upon consideration of the Defendant's consent motion for an extension of time, Dkt. 16 , it is hereby ORDERED that the motion is GRANTED. It is further ORDERED that Defendant shall file its motion to stay on or before September 20, 2023, Plaintiff shall file its response on or before October 4, 2023, and Defendant shall file its reply on or before October 18, 2023. Signed by Judge Randolph D. Moss on 9/9/2023. (lcrdm1) (Entered: 09/09/2023) |
| 2023-09-14 | 17 | MOTION to Stay by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Attachments: # 1 Memorandum in Support, # 2 Declaration, # 3 Exhibit 1)(Adebonojo, Kenneth) (Entered: 09/14/2023) |
| 2023-09-29 | 18 | Joint MOTION to Modify Briefing Schedule by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Adebonojo, Kenneth) (Entered: 09/29/2023) |
| 2023-10-02 | | MINUTE ORDER: Upon consideration of the parties' motion to modify briefing schedule, Dkt. 18 , it is hereby ORDERED that the motion is GRANTED. It is further ORDERED that Plaintiff file a response to Defendant's motion to stay, Dkt. 17 , on or before October 11, 2023. Defendant's reply, if any, must be filed on or before November 7, 2023. Signed by Judge Randolph D. Moss on 10/2/2023. (lcrdm1) (Entered: 10/02/2023) |
| 2023-10-11 | 19 | Memorandum in opposition to re 17 Motion to Stay filed by CHILDREN'S HEALTH DEFENSE. (Attachments: # 1 Decl. Karl Jablonowski)(Flores, Ray) (Entered: 10/11/2023) |
| 2023-11-07 | 20 | REPLY to opposition to motion re 17 MOTION to Stay filed by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Attachments: # 1 Exhibit, # 2 Exhibit)(Adebonojo, Kenneth) (Entered: 11/07/2023) |
| 2023-11-09 | 21 | MOTION for Leave to File by CHILDREN'S HEALTH DEFENSE. (Attachments: # 1 Text of Proposed Order)(Evans, Risa) (Entered: 11/09/2023) |
| 2023-11-21 | | MINUTE ORDER: Upon consideration of Plaintiff;s consent motion for leave to file a sur-reply, Dkt. 21 , it is hereby ORDERED that the motion is GRANTED. It is further ORDERED that Plaintiff shall file its sur-reply on or before November 28, 2023. Signed by Judge Randolph D. Moss on 11/21/2023. (lcrmd1) (Entered: 11/21/2023) |
| 2023-11-24 | 22 | SURREPLY to re 17 MOTION to Stay filed by CHILDREN'S HEALTH DEFENSE. (Evans, Risa) (Entered: 11/24/2023) |
| 2023-11-28 | 23 | NOTICE of Supplemental Authority by UNITED STATES FOOD AND DRUG ADMINISTRATION (Attachments: # 1 Exhibit A)(Adebonojo, Kenneth) (Entered: 11/28/2023) |
| 2023-12-19 | 24 | NOTICE of Filing of Supplemental Authority by UNITED STATES FOOD AND DRUG ADMINISTRATION (Attachments: # 1 Exhibit)(Adebonojo, Kenneth) (Entered: 12/19/2023) |
| 2024-01-12 | 25 | MEMORANDUM OPINION AND ORDER: It is hereby ORDERED that the FDAs motion for a stay, Dkt. 17 , is GRANTED. It is further ORDERED that the case is STAYED for six months. The parties are ORDERED to file a joint status report on or before June 14, 2024, notifying the Court whether a further stay is appropriate. Signed by Judge Randolph D. Moss on 1/12/2024. (lcrdm1) (Entered: 01/12/2024) |
| 2024-02-03 | 26 | NOTICE of Clarification by UNITED STATES FOOD AND DRUG ADMINISTRATION (Adebonojo, Kenneth) (Entered: 02/03/2024) |
| 2024-03-20 | 27 | NOTICE OF SUBSTITUTION OF COUNSEL by Dimitar Georgiev-Remmel on behalf of UNITED STATES FOOD AND DRUG ADMINISTRATION Substituting for attorney Kenneth A. Adebonojo (Georgiev-Remmel, Dimitar) (Entered: 03/20/2024) |
| 2024-06-14 | 28 | Joint STATUS REPORT by CHILDREN'S HEALTH DEFENSE. (Attachments: # 1 Text of Proposed Order Plaintiff's Proposed Order)(Evans, Risa) (Entered: 06/14/2024) |
| 2024-06-14 | 29 | NOTICE of Exhibits by UNITED STATES FOOD AND DRUG ADMINISTRATION re 28 Status Report (Attachments: # 1 Exhibit PHMPT II Production Order, # 2 Exhibit PHMPT II JSRs)(Georgiev-Remmel, Dimitar) (Entered: 06/14/2024) |
| 2024-06-27 | | MINUTE ORDER: Upon consideration of the parties' joint status report, Dkt. 28 , the parties are hereby ORDERED to appear for a status conference on July 9, 2024, at 10:30 a.m. in Courtroom 8. Signed by Judge Randolph D. Moss on 6/27/24. (lcrdm2) (Entered: 06/27/2024) |
| 2024-07-09 | | Minute Entry for proceedings held before Judge Randolph D. Moss: Status Conference held on 7/9/2024. For the reasons stated on the record the defendant is directed to file a status report on or before 8/9/24. Plaintiff shall file a response on or before 8/19/2024. (Court Reporter Sherry Lindsay) (zglw) (Entered: 07/09/2024) |
| 2024-07-11 | | MINUTE ORDER: For the reasons stated on the record in the July 9, 2024 status conference, the FDA is hereby ORDERED to file a status report on or before August 9, 2024, providing the following information: (1) whether there is any overlap between the documents Plaintiff requests in this case and any other FOIA request that is currently being processed (or has recently been processed) by the FDA; (2) the FDA's best estimate of when the agency will begin processing Plaintiff's FOIA request; (3) to the extent it is the agency's position that it cannot at present process Plaintiff's FOIA request due to the court orders in PHMPT II, what steps, if any, has the agency taken to seek redress regarding the burdens imposed by that litigation; (4) how many FDA employees are dedicated to responding to FOIA requests unrelated to the PHMPT II litigation, and more specifically, how many employees are dedicated to processing requests in ALFOI's complex queue unrelated to the PHMPT II litigation; (5) how many employees the FDA has hired and is in the process of hiring who will be (or can be) dedicated to responding to FOIA requests unrelated to the PHMPT II litigation (and who will respond to requests processed by ALFOI); and (6) the agency's estimate for how long it would take to review the approximately 150 pages that the agency has identified as responsive to Plaintiff's request. Plaintiff may file a response to the FDA's status report on or before August 19, 2024, and should indicate in that response whether a further hearing is necessary. Signed by Judge Randolph D. Moss on 7/11/2024. (lcrdm1) (Entered: 07/11/2024) |
| 2024-07-14 | 30 | TRANSCRIPT OF PROCEEDINGS before Judge Randolph D. Moss held on 7/9/24; Page Numbers: 1-25. Date of Issuance:7/14/24. Court Reporter Sherry Lindsay, Telephone number 202-354-3053, Transcripts may be ordered by submitting the Transcript Order Form For the first 90 days after this filing date, the transcript may be viewed at the courthouse at a public terminal or purchased from the court reporter referenced above. After 90 days, the transcript may be accessed via PACER. Other transcript formats, (multi-page, condensed, CD or ASCII) may be purchased from the court reporter. NOTICE RE REDACTION OF TRANSCRIPTS: The parties have twenty-one days to file with the court and the court reporter any request to redact personal identifiers from this transcript. If no such requests are filed, the transcript will be made available to the public via PACER without redaction after 90 days. The policy, which includes the five personal identifiers specifically covered, is located on our website at www.dcd.uscourts.gov. Redaction Request due 8/4/2024. Redacted Transcript Deadline set for 8/14/2024. Release of Transcript Restriction set for 10/12/2024.(stl) (Entered: 07/14/2024) |
| 2024-08-09 | 31 | STATUS REPORT by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Attachments: # 1 Declaration of Suzann Burk)(Georgiev-Remmel, Dimitar) (Entered: 08/09/2024) |
| 2024-08-16 | 32 | RESPONSE re 31 Status Report Response to Defendant's Status Report by CHILDREN'S HEALTH DEFENSE. (Evans, Risa) Modified on 8/16/2024 to correct event/ add docket link (zjm). (Entered: 08/16/2024) |
| 2024-09-13 | | MINUTE ORDER: Upon consideration of Defendant's Status Report, Dkt. 31 , and Plaintiff's Response, Dkt. 32 , it is hereby ORDERED that the parties appear for a status conference via Zoom on October 4, 2024, at 9:00 a.m. Signed by Judge Randolph D. Moss on 09/13/2024. (lcrdm1) (Entered: 09/13/2024) |
| 2024-10-04 | | Minute Entry for proceedings held before Judge Randolph D. Moss: Status Conference held on 10/4/2024. Joint Status Report due by 10/18/2024. (Court Reporter Sherry Lindsay) (zglw) (Entered: 10/07/2024) |
| 2024-10-15 | 33 | TRANSCRIPT OF PROCEEDINGS before Judge Randolph D. Moss held on 10/4/2024; Page Numbers: 1-23. Date of Issuance:10/15/2024. Court Reporter Sherry Lindsay, Telephone number 202-354-3053, Transcripts may be ordered by submitting the Transcript Order Form For the first 90 days after this filing date, the transcript may be viewed at the courthouse at a public terminal or purchased from the court reporter referenced above. After 90 days, the transcript may be accessed via PACER. Other transcript formats, (multi-page, condensed, CD or ASCII) may be purchased from the court reporter. NOTICE RE REDACTION OF TRANSCRIPTS: The parties have twenty-one days to file with the court and the court reporter any request to redact personal identifiers from this transcript. If no such requests are filed, the transcript will be made available to the public via PACER without redaction after 90 days. The policy, which includes the five personal identifiers specifically covered, is located on our website at www.dcd.uscourts.gov. Redaction Request due 11/5/2024. Redacted Transcript Deadline set for 11/15/2024. Release of Transcript Restriction set for 1/13/2025.(stl) (Entered: 10/15/2024) |
| 2024-10-18 | 34 | Joint STATUS REPORT by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Georgiev-Remmel, Dimitar) (Entered: 10/18/2024) |
| 2024-10-24 | | MINUTE ORDER: Upon consideration of the parties' status reports, Dkts. 31 , 32 , and 34 , as well as the discussion at the status conference held on October 4, 2024, it is hereby ORDERED that Defendant shall begin processing the responsive documents no later than August 9, 2026 and, to the extent possible and consistent with the placement of the request in the queue of similarly situated requesters, at an earlier date. It is further ORDERED, moreover, that the FDA shall file status reports with the Court every 90 days (starting on December 2, 2024) updating Plaintiff and the Court regarding Plaintiff's placement in the queue, the agency's best estimate of when it can begin processing the request, any new and unanticipated demands on the agency's FOIA staff, and the number of agency employees working on processing FOIA requests. In its status report from August 9, 2024, Dkt. 31 , Defendant represented that the "agency's best estimate of when it will begin processing Plaintiff's FOIA request" is "when it reaches the front of the Complex Track in approximately 24 to 36 months." Dkt. 31 at 5. The Court appreciates the unusual and extraordinary demands placed on the FDA in other litigation and also recognizes that other, similarly situated FOIA requesters filed their requests before the request at issue in this case was filed and that it would be unfair to push those requests further back in the queue. The Court also recognizes that the FDA has hired and trained additional staff to assist with the extraordinary burden that it currently faces. But, at the same time, the Court understands that the purposes of FOIA require agencies to process FOIA requests as promptly as possible and that the delay in this case--even if unavoidable in light of the demands placed on the FDA in other litigation--is antithetical to the purposes of FOIA. As a result, all that the Court can do is require the most expeditious processing of the request at issue, consistent with reality. This may require the agency to hire yet additional staff, and it may require the agency to ensure that other similarly situated FOIA requesters are not allowed to jump the queue in front of Plaintiff in this case. For present purposes, however, the Court will simply order that processing begin no later than 24 months from the filing of the FDA's August 9, 2024 status report, Dkt. 31 , that the agency make its best efforts (including, to the extent possible hiring yet additional staff) to process this request as soon as it can possibly do so, consistent with the rights of other FOIA requesters and the other burdens the agency currently faces, and that the FDA keep Plaintiff and the Court updated regarding its backlog, resources, and ability to process complex FOIA requests. The Court notes that this order is without prejudice to Plaintiff seeking an earlier processing date based on changed circumstances or new information. Signed by Judge Randolph D. Moss on 10/24/2024. (lcrdm1) (Entered: 10/24/2024) |
| 2024-11-21 | 35 | MOTION for Order for Timely Processing by CHILDREN'S HEALTH DEFENSE. (Attachments: # 1 Text of Proposed Order)(Evans, Risa) (Entered: 11/21/2024) |
| 2024-11-25 | 36 | MOTION for Extension of Time to File Response/Reply as to 35 MOTION for Order for Timely Processing by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Georgiev-Remmel, Dimitar) (Entered: 11/25/2024) |
| 2024-11-25 | | MINUTE ORDER: Upon consideration of Defendant's Motion for Extension of Time to File Response/Reply, Dkt. 36 , Plaintiff is hereby ORDERED to respond to the Motion on or before November 26, 2024, at 2:00 p.m. Signed by Judge Randolph D. Moss on 11/25/2024. (lcrdm1) (Entered: 11/25/2024) |
| 2024-11-26 | 37 | RESPONSE re 36 MOTION for Extension of Time to File Response/Reply as to 35 MOTION for Order for Timely Processing filed by CHILDREN'S HEALTH DEFENSE. (Evans, Risa) (Entered: 11/26/2024) |
| 2024-11-26 | | MINUTE ORDER: Upon consideration of Defendant's Motion for Extension of Time to File Response/Reply, Dkt. 36 , and Plaintiff's Response, Dkt. 37 , it is hereby ORDERED that the motion is GRANTED, and that Defendant shall respond or reply to Plaintiff's Motion on or before January 9, 2025. The Court notes that no further extensions will be granted, barring extraordinary circumstances. Signed by Judge Randolph D. Moss on 11/26/2024. (lcrdm1) (Entered: 11/26/2024) |
| 2024-12-02 | 38 | STATUS REPORT by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Georgiev-Remmel, Dimitar) (Entered: 12/02/2024) |
| 2025-01-08 | 39 | Memorandum in opposition to re 35 Motion for Order filed by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Georgiev-Remmel, Dimitar) (Entered: 01/08/2025) |
| 2025-01-10 | 40 | NOTICE OF SUPPLEMENTAL AUTHORITY by UNITED STATES FOOD AND DRUG ADMINISTRATION (Georgiev-Remmel, Dimitar) (Entered: 01/10/2025) |
| 2025-01-13 | | MINUTE ORDER: In light of Defendant's Notice of Supplemental Authority, Dkt. 40 , which addressed Plaintiff's Motion for Order for Timely Processing, Dkt. 35 , it is hereby ORDERED that Plaintiff respond to the Notice on or before January 17, 2025, and address whether the pending motion has been mooted, Dkt. 35 , given Defendant's representation that responsive documents to Plaintiff's FOIA request 2022-5597 have been produced and sent to Plaintiffs. Signed by Judge Randolph D. Moss on 1/13/2025. (lcrdm1) (Entered: 01/13/2025) |
| 2025-01-15 | 41 | RESPONSE TO ORDER OF THE COURT re Order,,, Set Deadlines,, and Reply to Defendant's Opposition filed by CHILDREN'S HEALTH DEFENSE. (Evans, Risa) (Entered: 01/15/2025) |
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