Complaint — ICAN v. FDA (FOIA, Pfizer Post-Market Studies)

Record facts

U.S. District Court for the District of Columbia · No. 1:25-cv-00825-RDM · Doc. 1 · 2025-03-19 · Docket on CourtListener

Full text

1 
UNITED STATES DISTRICT COURT 
FOR THE DISTRICT OF COLUMBIA 
INFORMED CONSENT ACTION NETWORK, 
2025 Guadalupe Street, Suite 260 
Austin, Texas 78705 
 
 
 
Plaintiff, 
 
-against- 
Civil Action No. 1:25-cv-825 
 
 
FOOD AND DRUG ADMINISTRATION  
10903 New Hampshire Avenue 
Silver Spring, MD 20993-0002 
 
-and-  
 
U.S. DEPARTMENT OF HEALTH AND 
HUMAN SERVICES, 
200 Independence Avenue S.W. 
Washington, DC 20201 
 
 
Defendants. 
 
COMPLAINT 
Plaintiff Informed Consent Action Network (“ICAN” or “Plaintiff”) brings this action 
against defendants Food and Drug Administration (“FDA”) and the United States Department of 
Health and Human Services (“HHS”) (collectively “Defendants”) to compel compliance with the 
Freedom of Information Act, 5 U.S.C. § 552 (“FOIA”). As grounds therefore, Plaintiff alleges as 
follows: 
JURISDICTION AND VENUE 
1. 
The Court has jurisdiction over this action pursuant to 5 U.S.C. § 552(a)(4)(B) and 
28 U.S.C. § 1331.  
2. 
Venue is proper in this district pursuant 5 U.S.C. § 522(a)(4)(B) and 28 U.S.C. § 
1331. 
Case 1:25-cv-00825-RDM     Document 1     Filed 03/19/25     Page 1 of 6

2 
PARTIES 
3. 
Plaintiff ICAN is a not-for-profit organization formed and existing under the laws 
of the state of Texas, with its principal office located at 2025 Guadalupe Street, Suite 260, Austin, 
Texas 78705. Plaintiff is in good standing with the Texas Secretary of State. 
4. 
Defendant FDA is an agency within the Executive Branch of the United States 
Government, organized within the U.S. Department of Health and Human Services. FDA is an 
agency within the meaning of 5 U.S.C. § 552(f). FDA has possession, custody, and control of 
records to which Plaintiff seeks access. 
5. 
Defendant HHS is an agency within the Executive Branch of the United States 
Government. HHS is an agency within the meaning of 5 U.S.C. § 552(f) and has possession, 
custody, and control of records to which Plaintiff seeks access. 
STATEMENT OF FACTS 
6. 
On January 26, 2024, Plaintiff sent a FOIA request to FDA seeking copies of the 
following records: 
The final study reports for the following studies: 
 
(1) C4591001: Deferred pediatric study to evaluate the safety and 
effectiveness of COMIRNATY in children 12 years through 15 
years of age; 
(2) C4591014: Pfizer-BioNTech COVID-19 BNT162b2 Vaccine 
Effectiveness Study - Kaiser Permanente Southern California; 
and 
(3) C4591031: Sub-study incidence to prospectively of subclinical 
myocarditis assess the following administration of a third dose 
of COMIRNATY in a subset of participants 16 to 30 years of 
age. 
 
Information Helpful to Fulfilling the Request: The three studies are 
Commitments 1, 9, and 13 of the postmarket requirements for the 
Pfizer-BioNTech 
COVID-19 
vaccine, 
attached 
hereto 
as 
Attachment A. 
 
(Exhibit 1.) 
Case 1:25-cv-00825-RDM     Document 1     Filed 03/19/25     Page 2 of 6

3 
 
7. 
Defendant FDA acknowledged Plaintiff’s FOIA request on January 29, 2024, and 
assigned the request FOIA number 2024-965. (Exhibit 2.) 
8. 
As of the date of this Complaint, Defendants have failed to: (i) determine whether 
to comply with the request as required under 5 U.S.C. § 552(6)(A)(i); (ii) notify Plaintiff of any 
such determination or the reasons therefor as required under § 552 (60(A)(i)(I); (iii) advise Plaintiff 
of the right to appeal any adverse determination not to comply with the request, as required under 
§ 552(6)(A)(i)(III)(aa); or (iv) produce the requested records or otherwise demonstrate that the 
requested records are exempt from disclosure pursuant to § 552(b).  
COUNT I 
FAILURE TO MAKE DETERMINATION BY REQUIRED DEADLINE 
(VIOLATION OF FOIA, 5 U.S.C. § 552) 
9. 
Plaintiff realleges the previous paragraphs as if fully stated herein.  
10. 
Defendants are in violation of FOIA.  
11. 
5 U.S.C. § 552(a)(6)(A)(i) requires Defendants to make a final determination on 
Plaintiff’s request no later than twenty (20) business days from acknowledgement of the request. 
Because Defendants failed to make a final determination on Plaintiff’s request within the time 
limits set by FOIA, under § 552(6)(C)(i) Plaintiff is deemed to have exhausted its administrative 
appeal remedies. 
12. 
Plaintiff is being irreparably harmed because of Defendants’ violation of FOIA and 
Plaintiff will continue to be irreparably harmed unless Defendants are compelled to comply with 
the law. 
13. 
Plaintiff has no adequate remedy at law. 
Case 1:25-cv-00825-RDM     Document 1     Filed 03/19/25     Page 3 of 6

4 
COUNT II 
FAILURE TO PROVIDE AN ESTIMATED COMPLETION DATE 
(VIOLATION OF FOIA, 5 U.S.C. § 552) 
14. 
Plaintiff realleges the previous paragraphs as if fully stated herein.  
15. 
Defendants are in violation of FOIA. 
16. 
The agency never provided an estimated date of completion. 
COUNT III 
IMPROPER WITHHOLDING OF INFORMATION AND DATA 
(VIOLATION OF FOIA, 5 U.S.C. § 552) 
17. 
Plaintiff realleges the previous paragraphs as if fully stated herein. 
18. 
Defendants have failed to establish that they adequately applied an exemption to—
or withheld—any responsive records. 
19. 
Defendants are in violation of FOIA. 
COUNT IV 
FAILURE TO ESTABLISH AN ADEQUATE SEARCH  
(VIOLATION OF FOIA, 5 U.S.C. § 552) 
20. 
Plaintiff realleges the previous paragraphs as if fully stated herein.  
21. 
Defendants have failed to establish that they adequately searched for responsive 
records as required by 5 U.S.C. § 552 (a)(3)(C) and (D).  
22. 
Defendants are in violation of FOIA. 
COUNT V 
ENTITLEMENT TO WAIVER OF SEARCH AND DUPLICATION FEES 
 
23. 
Plaintiff realleges the previous paragraphs as if fully stated herein. 
24. 
Defendants are in violation of FOIA. 
25. 
Plaintiff sought a waiver of search and duplication fees pursuant to 5 U.S.C. § 
552(a)(4)(A)(ii)(II).  
Case 1:25-cv-00825-RDM     Document 1     Filed 03/19/25     Page 4 of 6

5 
26. 
Plaintiff is further entitled to a waiver of fees pursuant to 5 U.S.C. § 
552(a)(4)(A)(viii) because Defendants failed, within 20 days, to produce the requested records and 
otherwise failed to comply with the statutory requirements of 5 U.S.C. § 522 within the time limits 
set forth therein. 
REQUESTED RELIEF 
WHEREFORE, Plaintiff respectfully requests that the Court:  
a. 
Declare that Defendants’ current and continued delay in processing Plaintiff’s 
FOIA Request is unlawful under FOIA;  
b. 
Order Defendants to conduct searches for any and all records responsive to 
Plaintiff’s FOIA request and demonstrate that they employed search methods reasonably likely to 
lead to the discovery of records responsive to Plaintiff’s FOIA request; 
c. 
Order Defendants to produce, by a date certain, any and all non-exempt records 
responsive to Plaintiff’s FOIA request and a Vaughn index of any responsive records withheld 
under any claimed exemption;  
d. 
Enjoin Defendants from continuing to withhold any and all non-exempt records 
responsive to Plaintiff’s FOIA request;  
e. 
Maintain jurisdiction over this action pursuant to 552(a)(6)(C)(i) until Defendants 
comply with FOIA and all orders of this Court; 
f. 
Grant Plaintiff an award of attorneys’ fees and other litigation costs reasonably 
incurred in this action pursuant to 5 U.S.C. § 552(a)(4)(E);  
g. 
Grant Plaintiff a fee waiver pursuant to 5 U.S.C. § 552(a)(4)(A)(viii); and 
 
 
 
Case 1:25-cv-00825-RDM     Document 1     Filed 03/19/25     Page 5 of 6

6 
h. 
Grant Plaintiff such other relief as the Court deems just and proper. 
 
Dated: March 19, 202  
 
 
 
SIRI & GLIMSTAD LLP 
 
 /s/Mark Taylor 
 
 
  
Elizabeth A. Brehm, DC Bar No. NY0532 
Mark Taylor, DC Bar No. ID0006 
745 Fifth Ave, Suite 500 
New York, New York 10151 
Tel: (240) 732-6737 
ebrehm@sirillp.com 
mtaylor@sirillp.com  
 
 
Case 1:25-cv-00825-RDM     Document 1     Filed 03/19/25     Page 6 of 6

File and source

File

gov.uscourts.dcd.278576.1.0.pdf

Size

159,391 bytes

SHA-256

460366e88e0c9d86a55ec251ecc13a2ce69c738deb328fc05ba9de17c71b2a61

Our copy

gov.uscourts.dcd.278576.1.0.pdf

Original

archive.org