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Case TitleINFORMED CONSENT ACTION NETWORK v. FOOD AND DRUG ADMINISTRATION et al
DistrictDistrict of Columbia
CityWashington, DC
Case Number1:2024cv01761
Date Filed2024-06-17
Date ClosedOpen
JudgeJudge Amir H. Ali
PlaintiffINFORMED CONSENT ACTION NETWORK
Case DescriptionInformed Consent Action Network submitted a FOIA request to the FDA for records concerning specific clinical trials. The agency acknowledged receipt of the request and told ICAN that processing would take two years. ICAN then filed suit.
Complaint issues: Failure to respond within statutory time limit, Adequacy - Search, Litigation - Vaughn index, Litigation - Attorney's fees

DefendantFOOD AND DRUG ADMINISTRATION
DefendantU.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Documents
Docket
Complaint
Complaint attachment 1
Complaint attachment 2
Complaint attachment 3
Complaint attachment 4
Complaint attachment 5
Complaint attachment 6
Complaint attachment 7
Complaint attachment 8
Opinion/Order [18]
User-contributed Documents
 
Docket Events (Hide)
Date FiledDoc #Docket Text

2024-06-171COMPLAINT against All Defendants ( Filing fee $ 405 receipt number ADCDC-10968713) filed by INFORMED CONSENT ACTION NETWORK. (Attachments: # 1 Exhibit 1, # 2 Exhibit 2, # 3 Exhibit 3, # 4 Civil Cover Sheet, # 5 Summons to FDA, # 6 Summons to HHS, # 7 Summons to USAG, # 8 Summons to USAO)(Pietrowski, Richard) (Entered: 06/17/2024)
2024-06-172LCvR 26.1 CERTIFICATE OF DISCLOSURE of Corporate Affiliations and Financial Interests by INFORMED CONSENT ACTION NETWORK (Pietrowski, Richard) (Entered: 06/17/2024)
2024-06-173NOTICE of Appearance by Elizabeth Ann Brehm on behalf of INFORMED CONSENT ACTION NETWORK (Brehm, Elizabeth) (Entered: 06/17/2024)
2024-06-18Case Assigned to Judge Carl J. Nichols. (zmtm) (Entered: 06/18/2024)
2024-06-184SUMMONS (4) Issued Electronically as to FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. Attorney and U.S. Attorney General (Attachments: # 1 Notice and Consent)(zmtm) (Entered: 06/18/2024)
2024-06-255STANDING ORDER. Signed by Judge Carl J. Nichols on June 25, 2024. (lccjn1) (Entered: 06/25/2024)
2024-06-276RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed. FOOD AND DRUG ADMINISTRATION served on 6/22/2024 (Pietrowski, Richard) (Entered: 06/27/2024)
2024-06-277RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES served on 6/24/2024 (Pietrowski, Richard) (Entered: 06/27/2024)
2024-06-278RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed on United States Attorney General. Date of Service Upon United States Attorney General 06/24/2024. (Pietrowski, Richard) (Entered: 06/27/2024)
2024-06-279RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed as to the United States Attorney. Date of Service Upon United States Attorney on 6/19/2024. Answer due for ALL FEDERAL DEFENDANTS by 7/19/2024. (Pietrowski, Richard) (Entered: 06/27/2024)
2024-07-1610NOTICE of Appearance by Brenda A. Gonzalez Horowitz on behalf of All Defendants (Gonzalez Horowitz, Brenda) (Entered: 07/16/2024)
2024-07-1911ANSWER to Complaint by FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES.(Gonzalez Horowitz, Brenda) (Entered: 07/19/2024)
2024-08-1612Joint STATUS REPORT by FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES. (Gonzalez Horowitz, Brenda) (Entered: 08/16/2024)
2024-09-03MINUTE ORDER. Upon consideration of the 12 Joint Status Report, it is hereby ORDERED that Defendant file a motion for an Open America stay by September 27, 2024. It is further ORDERED that Plaintiff shall file its response to the motion, if any, by October 11, 2024, and Defendant shall file any reply in support of the motion by October 18, 2024. So ORDERED by Judge Carl J. Nichols on September 3, 2024. (lccjn1) (Entered: 09/03/2024)
2024-09-2713MOTION to Stay by FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES. (Attachments: # 1 Declaration of Suzann Burk, # 2 Attachment A, Burk Decl.)(Gonzalez Horowitz, Brenda) (Entered: 09/27/2024)
2024-10-0814Joint STATUS REPORT by FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES. (Gonzalez Horowitz, Brenda) (Entered: 10/08/2024)
2024-10-1015RESPONSE re 13 MOTION to Stay filed by INFORMED CONSENT ACTION NETWORK. (Attachments: # 1 Text of Proposed Order)(Pietrowski, Richard) (Entered: 10/10/2024)
2024-10-1416Consent MOTION for Extension of Time to File Reply to Motion to Stay by FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES. (Gonzalez Horowitz, Brenda) (Entered: 10/14/2024)
2024-10-15MINUTE ORDER. Upon consideration of Defendants' 16 Consent Motion for Extension of Time, it is hereby ORDERED that the Motion is GRANTED and that Defendants shall file their reply on or before October 25, 2024. SO ORDERED by Judge Carl J. Nichols on 10/15/24. (lccjn1) (Entered: 10/15/2024)
2024-10-2517REPLY to opposition to motion re 13 Motion to Stay filed by FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES. (Attachments: # 1 Declaration of Sarah Kotler)(Gonzalez Horowitz, Brenda) (Entered: 10/25/2024)
2024-11-2018ORDER granting in part and denying in part 13 Motion to Stay. Signed by Judge Carl J. Nichols on 11/20/24. (lccjn1) (Entered: 11/20/2024)
2024-11-27Case directly reassigned to Judge Amir H. Ali. Judge Carl J. Nichols is no longer assigned to the case. (ztnr) (Entered: 11/27/2024)
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