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Case TitleINFORMED CONSENT ACTION NETWORK v. FOOD AND DRUG ADMINISTRATION
DistrictDistrict of Columbia
CityWashington, DC
Case Number1:2023cv00219
Date Filed2023-01-25
Date ClosedOpen
JudgeJudge Reggie B. Walton
PlaintiffINFORMED CONSENT ACTION NETWORK
Case DescriptionInformed Consent Action Network submitted a FOIA request to the FDA for records concerning Empirical Bayesian data mining and Empirical Bayesian Geometric Means. The agency acknowledged receipt of the request. The agency denied the request under Exemption 5 (privileges). ICAN filed an administrative appeal, but after hearing nothing further from the agency, ICAN filed suit.
Complaint issues: Failure to respond within statutory time limit, Adequacy - Search, Litigation - Vaughn index, Litigation - Attorney's fees

DefendantUNITED STATES FOOD AND DRUG ADMINISTRATION
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
User-contributed Documents
 
Docket Events (Hide)
Date FiledDoc #Docket Text

2023-01-251COMPLAINT against FOOD AND DRUG ADMINISTRATION ( Filing fee $ 402 receipt number ADCDC-9813980) filed by INFORMED CONSENT ACTION NETWORK. (Attachments: # 1 Exhibit 101, # 2 Exhibit 102, # 3 Civil Cover Sheet, # 4 Summons as to FDA, # 5 Summons as to U.S. Attorney General, # 6 Summons as to U.S. Attorney)(Farnsworth, Colin) (Entered: 01/25/2023)
2023-01-252LCvR 26.1 CERTIFICATE OF DISCLOSURE of Corporate Affiliations and Financial Interests by INFORMED CONSENT ACTION NETWORK (Farnsworth, Colin) (Entered: 01/25/2023)
2023-01-253MOTION for Leave to Appear Pro Hac Vice :Attorney Name- Aaron Siri, Filing fee $ 100, receipt number ADCDC-9813984. Fee Status: Fee Paid. by INFORMED CONSENT ACTION NETWORK. (Farnsworth, Colin) (Entered: 01/25/2023)
2023-01-254MOTION for Leave to Appear Pro Hac Vice :Attorney Name- Elizabeth A. Brehm, Filing fee $ 100, receipt number ADCDC-9813986. Fee Status: Fee Paid. by INFORMED CONSENT ACTION NETWORK. (Farnsworth, Colin) (Entered: 01/25/2023)
2023-01-26Case Assigned to Judge Reggie B. Walton. (zsl) (Entered: 01/26/2023)
2023-01-265SUMMONS (3) Issued Electronically as to INFORMED CONSENT ACTION NETWORK, U.S. Attorney and U.S. Attorney General (Attachment: # 1 Notice and Consent)(zsl) (Entered: 01/26/2023)
2023-01-27MINUTE ORDER. The Court having considered the 3 Plaintiff's Motion for Admission of Attorney Aaron Siri, and it appearing to the Court that the attorney referenced therein meets the requirements for pro hac vice admission under this Court's rules, it is hereby ORDERED that the 3 Plaintiff's Motion for Admission of Attorney Aaron Siri is GRANTED. It is further ORDERED that Aaron Siri, Siri & Glimstad LLP, 745 Fifth Avenue, Suite 500, New York, New York, 10151, is ADMITTED to practice before the Court pro hac vice in this case. Counsel should register for e-filing via PACER and file a notice of appearance pursuant to LCvR 83.6(a) Click for instructions . Signed by Judge Reggie B. Walton on January 27, 2023. (lcrbw3) (Entered: 01/27/2023)
2023-01-27MINUTE ORDER. The Court having considered the 4 Plaintiff's Motion for Admission of Attorney Elizabeth A. Brehm, and it appearing to the Court that the attorney referenced therein meets the requirements for pro hac vice admission under this Court's rules, it is hereby ORDERED that the 4 Plaintiff's Motion for Admission of Attorney Elizabeth A. Brehm is GRANTED. It is further ORDERED that Elizabeth A. Brehm, Siri & Glimstad LLP, 745 Fifth Avenue, New York, New York, 10151, is ADMITTED to practice before the Court pro hac vice in this case. Counsel should register for e-filing via PACER and file a notice of appearance pursuant to LCvR 83.6(a) Click for instructions . Signed by Judge Reggie B. Walton on January 27, 2023. (lcrbw3) (Entered: 01/27/2023)
2023-02-016NOTICE of Appearance by Aaron Siri on behalf of INFORMED CONSENT ACTION NETWORK (Siri, Aaron) (Entered: 02/01/2023)
2023-02-017NOTICE of Appearance by Elizabeth Ann Brehm on behalf of INFORMED CONSENT ACTION NETWORK (Brehm, Elizabeth) (Entered: 02/01/2023)
2023-02-108RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed. FOOD AND DRUG ADMINISTRATION served on 2/2/2023 (Farnsworth, Colin) (Entered: 02/10/2023)
2023-02-109RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed on United States Attorney General. Date of Service Upon United States Attorney General 02/02/2023. (Farnsworth, Colin) (Entered: 02/10/2023)
2023-02-1010RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed as to the United States Attorney. Date of Service Upon United States Attorney on 1/30/2023. Answer due for ALL FEDERAL DEFENDANTS by 3/1/2023. (Farnsworth, Colin) (Entered: 02/10/2023)
2023-02-1011GENERAL ORDER FOR CIVIL CASES BEFORE THE HONORABLE REGGIE B. WALTON. Signed by Judge Reggie B. Walton on February 10, 2023. (lcrbw3) (Entered: 02/10/2023)
2023-03-0112NOTICE of Appearance by Brian J. Levy on behalf of FOOD AND DRUG ADMINISTRATION (Levy, Brian) (Entered: 03/01/2023)
2023-03-0113ANSWER to Complaint by FOOD AND DRUG ADMINISTRATION.(Levy, Brian) (Entered: 03/01/2023)
2023-03-01MINUTE ORDER. To ensure the expeditious resolution of this action, and because this qualifies as an exempted case under Local Civil Rule 16.3(b), it is hereby ORDERED that, on or before March 29, 2023, the parties shall file a joint proposed briefing schedule governing further proceedings. Signed by Judge Reggie B. Walton on March 1, 2023. (lcrbw3) (Entered: 03/01/2023)
2023-03-01Set/Reset Deadlines: Parties Proposed Joint Briefing Schedule due by 3/29/2023 (mac) (Entered: 03/01/2023)
2023-03-2914Joint STATUS REPORT by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Attachments: # 1 Text of Proposed Order)(Levy, Brian) (Entered: 03/29/2023)
2023-03-29MINUTE ORDER. Upon consideration of the parties' 14 Joint Status Report, and for good cause shown, it is hereby ORDERED that, on or before April 19, 2023, the parties shall submit a joint status report regarding how they wish to proceed in this case. Signed by Judge Reggie B. Walton on March 29, 2023. (lcrbw3) (Entered: 03/29/2023)
2023-04-1915Joint STATUS REPORT by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Attachments: # 1 Text of Proposed Order)(Levy, Brian) (Entered: 04/19/2023)
2023-04-21MINUTE ORDER. Upon consideration of the parties' 15 Joint Status Report, and for good cause shown, it is hereby ORDERED that, on or before May 19, 2023, the parties shall submit a joint status report regarding how they wish to proceed in this case. Signed by Judge Reggie B. Walton on April 21, 2023. (lcrbw3) (Entered: 04/21/2023)
2023-05-1716NOTICE OF WITHDRAWAL OF APPEARANCE as to INFORMED CONSENT ACTION NETWORK. Attorney Colin M. Farnsworth terminated. (Brehm, Elizabeth) (Entered: 05/17/2023)
2023-05-1917Joint STATUS REPORT by UNITED STATES FOOD AND DRUG ADMINISTRATION (Attachments: # 1 Text of Proposed Order)(Levy, Brian) Modified event title on 5/22/2023 (znmw). (Entered: 05/19/2023)
2023-06-1618Joint STATUS REPORT by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Attachments: # 1 Text of Proposed Order)(Levy, Brian) (Entered: 06/16/2023)
2023-06-20MINUTE ORDER. Upon consideration of the parties' 18 Joint Status Report, and for good cause shown, it is hereby ORDERED that, on or before July 20, 2023, the parties shall submit a joint status report regarding how they wish to proceed in this case. Signed by Judge Reggie B. Walton on June 20, 2023. (lcrbw3) (Entered: 06/20/2023)
2023-07-2019Joint STATUS REPORT by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Attachments: # 1 Text of Proposed Order)(Levy, Brian) (Entered: 07/20/2023)
2023-07-21MINUTE ORDER. Upon consideration of the parties' 19 Joint Status Report, and for good cause shown, it is hereby ORDERED that, on or before August 21, 2023, the parties shall submit a joint status report regarding how they wish to proceed in this case. Signed by Judge Reggie B. Walton on July 21, 2023. (lcrbw3) (Entered: 07/21/2023)
2023-08-2120Joint STATUS REPORT by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Attachments: # 1 Text of Proposed Order Plaintiff's Proposed Order, # 2 Text of Proposed Order Defendant's Proposed Order)(Levy, Brian) (Entered: 08/21/2023)
2023-08-22MINUTE ORDER. Upon consideration of the parties' 20 Joint Status Report, and for good cause shown, it is hereby ORDERED that, on or before September 21, 2023, the parties shall submit a joint status report regarding how they wish to proceed in this case. Signed by Judge Reggie B. Walton on August 22, 2023. (lcrbw3) (Entered: 08/22/2023)
2023-09-1421MOTION to Stay by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Attachments: # 1 Memorandum in Support, # 2 Declaration, # 3 Exhibit, # 4 Text of Proposed Order)(Levy, Brian) (Entered: 09/14/2023)
2023-09-15MINUTE ORDER. The Court requiring additional information before resolving the 21 Defendant's Motion for an Eighteen-Month Stay of Proceedings, it is hereby ORDERED that the plaintiff shall file an opposition to the defendant's motion on or before September 29, 2023, and the defendant shall file a reply in support of its motion on or before October 6, 2023. It is further ORDERED that on October 16, 2023, at 11:00 a.m., the parties shall appear before the Court for a motion hearing, via teleconference, by calling 1-877-873-8017 and entering the Court's access code (8583213) followed by the pound key (#). Signed by Judge Reggie B. Walton on September 15, 2023. (lcrbw3) (Entered: 09/15/2023)
2023-09-2122Joint STATUS REPORT by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Levy, Brian) (Entered: 09/21/2023)
2023-09-2523Joint MOTION to Modify Scheduling Order by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Attachments: # 1 Text of Proposed Order Plaintiff's Proposed Order, # 2 Text of Proposed Order Defendant's Proposed Order)(Levy, Brian) (Entered: 09/25/2023)
2023-09-26MINUTE ORDER. Upon consideration of the 23 Joint Motion to Modify Scheduling Order, it is hereby ORDERED that the 23 Joint Motion to Modify Scheduling Order is GRANTED. It is further ORDERED that the plaintiff shall file its response to the 21 Defendant's Motion for an Eighteen-Month Stay of Proceedings on or before October 6, 2023, and the defendant shall file a reply in support of its motion on or before November 3, 2023. It is further ORDERED that the motion hearing currently scheduled for October 16, 2023, via teleconference, is CONTINUED to November 20, 2023, at 9:00 a.m., via teleconference. Signed by Judge Reggie B. Walton on September 26, 2023. (lcrbw3) (Entered: 09/26/2023)
2023-10-0624RESPONSE re 21 MOTION to Stay filed by INFORMED CONSENT ACTION NETWORK. (Attachments: # 1 Declaration of Elizabeth A. Brehm, # 2 Text of Proposed Order)(Brehm, Elizabeth) (Entered: 10/06/2023)
2023-11-0225Consent MOTION to Modify the Briefing Schedule by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Attachments: # 1 Text of Proposed Order)(Levy, Brian) (Entered: 11/02/2023)
2023-11-03MINUTE ORDER. Upon consideration of the defendant's 25 Consent Motion to Modify the Briefing Schedule, and for good cause shown, it is hereby ORDERED that the motion is GRANTED. It is further ORDERED that, on or before November 10, 2023, the defendant shall file its reply in support of the 21 Defendant's Motion for an Eighteen-Month Stay of Proceedings. Signed by Judge Reggie B. Walton on November 3, 2023. (lcrbw3) (Entered: 11/03/2023)
2023-11-0926REPLY to opposition to motion re 21 MOTION to Stay filed by UNITED STATES FOOD AND DRUG ADMINISTRATION. (Attachments: # 1 Declaration, # 2 Declaration)(Levy, Brian) (Entered: 11/09/2023)
2023-11-20Minute Entry for telephonic proceedings held before Judge Reggie B. Walton: Motion Hearing held on 11/20/2023. Oral arguments heard. The Court grants 21 Defendant's Motion for an Eighteen-Month Stay of Proceedings, for the reasons set forth on the record. Status Conference set for 5/24/2024 at 9:00 AM via teleconference before Judge Reggie B. Walton. (Court Reporter: Lisa Moreira) (zalh) (Entered: 11/20/2023)
2023-11-2127ORDER. In accordance with the attached Order, it is hereby ORDERED that the 21 Defendant's Motion for an Eighteen-Month Stay of Proceedings is GRANTED IN PART AND DENIED IN PART. More specifically, the defendant has "show[n] exceptional circumstances exist and that the agency [viz., the Food and Drug Administration] is exercising due diligence in responding to the [plaintiff's FOIA] request[.]" 5 U.S.C. § 552(a)(6)(C)(i); see Open America v. Watergate Special Prosecution Force, 547 F.2d 605, 616 (D.C. Cir. 1976) (holding that "exceptional circumstances exist" to justify a stay "when an agency... is deluged with a volume of [FOIA] requests for information vastly in excess of that anticipated by Congress" and "when the [agency's] existing resources are inadequate to deal with the volume of such requests within the time limits" provided by FOIA); Appleton v. Food and Drug Administration, 254 F. Supp. 2d 6, 10 (D.D.C. 2003) (concluding that "the defendants ha[d] demonstrated good-faith efforts and due diligence in processing the plaintiff's request on a first-in, first-out basis"). Accordingly, the motion is GRANTED to the extent that it seeks to vacate all pending deadlines in this case. The motion is DENIED in all other respects. It is further ORDERED that, on May 24, 2024, at 9:00 a.m., the parties shall appear before the Court for a status conference to appraise the Court of the status of this case. The parties shall appear before the Court via teleconference by calling 1-877-873-8017 and entering the Court's access code (8583213) followed by the pound key (#). Signed by Judge Reggie B. Walton on November 21, 2023. (lcrbw3) (Entered: 11/21/2023)
2023-12-1028TRANSCRIPT OF TELEPHONIC MOTION HEARING before Judge Reggie B. Walton held on November 20, 2023; Page Numbers: 1-12. Date of Issuance:December 10, 2023. Court Reporter/Transcriber Lisa A. Moreira, RDR, CRR, Telephone number (202) 354-3187, 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 12/31/2023. Redacted Transcript Deadline set for 1/10/2024. Release of Transcript Restriction set for 3/9/2024.(Moreira, Lisa) (Entered: 12/10/2023)
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