Joint Notice of Clarification — PHMPT v. FDA

Record facts

U.S. District Court, Northern District of Texas · No. 4:22-cv-00915-P · Doc. 51 · 2025-06-04 · Docket on CourtListener

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IN THE UNITED STATES DISTRICT COURT 
FOR THE NORTHERN DISTRICT OF TEXAS 
FORT WORTH DIVISION 
_____________________________________ 
PUBLIC HEALTH AND MEDICAL 
PROFESSIONALS FOR TRANSPARENCY, 
ET AL., 
 
 
Plaintiffs, 
 
v. 
 
UNITED STATES FOOD AND DRUG 
ADMINISTRATION, 
 
 
Defendant. 
  
 
 
 
 
 
Civil Action No. 4:22-CV-0915-P 
JOINT NOTICE OF CLARIFICATION 
The parties submit this notice to clarify the parties’ production agreement, as described in 
the May 14, 2025 Joint Status Report (ECF No. 49 at ¶ 5a-e).  In that Joint Status Report, the 
parties explained the current status of Defendant’s production of two separate files:   
(1) the responsive Pfizer COVID-19 supplemental emergency use 
authorization file for the 12-to-15 years of age indication (“Pfizer 
sEUA file”), which Defendant had agreed to produce by September 
2, 2025 by producing at least 180,000 pages a month with the first 
production occurring on or before August 1, 2025, and 
(2) 
the 
responsive 
Moderna 
COVID-19 
emergency 
use 
authorization file (“Moderna EUA file”), which Defendant had 
agreed to produce by October 1, 2026 by producing at least 180,000 
pages a month beginning on or before October 1, 2025.  
See ECF No. 49 at ¶ 5a-b.   
On May 15, 2025, the Court issued an order “based upon the Parties’ agreement.”  ECF 
No. 50.  The Court’s Order largely aligned with the parties’ production agreement in setting out a 
production schedule of 180,000 pages a month beginning on October 1, 2025 (i.e., as relevant to 
Case 4:22-cv-00915-P     Document 51     Filed 06/04/25      Page 1 of 4     PageID 448

 
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the Moderna EUA file), but the Order did not specifically mention Defendant’s production of the 
Pfizer sEUA file (which Defendant had agreed to complete by September 2, 2025, with the first 
production occurring no later than August 1, 2025, see ECF No. 49 at ¶ 5a).  For the avoidance of 
doubt, this notice is being filed to confirm that Defendant intends to abide by the complete terms 
of its agreement with Plaintiffs, including this provision regarding the Pfizer sEUA file.1  The 
parties therefore respectfully request that the Court enter an amended version of its May 15, 2025 
Order, so as to cover the Pfizer sEUA file as well as the Moderna EUA file.  The parties are 
submitting a proposed order to the Court’s “orders” email address.  
 
1 The parties’ agreement does not apply to any other case, including Public Health and Medical 
Professionals for Transparency v. FDA, Civ. A. No. 21-1058 (N.D. Tex.) (“PHMPT I”), where 
this Court ordered FDA to produce the “responsive EUA file” for the Pfizer COVID-19 vaccine 
for individuals sixteen years of age and older on or before June 30, 2025.  See December 6, 2024, 
Mem. Op. & Order (ECF No. 101). 
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Respectfully submitted, 
/s/ Elizabeth A. Brehm                 
Aaron Siri (pro hac vice)  
Elizabeth A. Brehm (pro hac vice)  
745 Fifth Ave, Suite 500 
New York, NY 10151 
Tel: (212) 532-1091 
aaron@sirillp.com    
ebrehm@sirillp.com   
 
Walker D. Moller (Texas Bar No. 24092851) 
501 Congress Avenue, Suite 150 – #343 
Austin, TX 78701 
Tel : (512) 265-5622 
wmoller@sirillp.com 
 
Attorneys for Plaintiffs 
 
NANCY E. LARSON 
ACTING UNITED STATES ATTORNEY 
 
/s/ Brian W. Stoltz                  
Brian W. Stoltz 
Assistant United States Attorney 
Texas Bar No. 24060668 
1100 Commerce Street, Third Floor 
Dallas, Texas 75242-1699 
Telephone: 214-659-8626 
Facsimile: 214-659-8807 
brian.stoltz@usdoj.gov 
 
Attorneys for Defendant 
 
Of Counsel: 
 
SEAN R. KEVENEY 
Acting General Counsel 
 
ROBERT F. FOSTER 
Deputy General Counsel 
Chief Counsel for Food, Research, and Drugs 
Department of Health and Human Services 
 
WENDY S. VICENTE 
Deputy Chief Counsel for Litigation 
 
DANLI SONG 
Associate Chief Counsel 
Office of the Chief Counsel 
U.S. Food and Drug Administration 
10903 New Hampshire Avenue 
Silver Spring, MD 20993 
(301) 273-4477 
Danli.Song@fda.hhs.gov 
 
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Certificate of Service 
 
On June 4, 2025 I electronically submitted the foregoing document with the clerk of court 
for the U.S. District Court, Northern District of Texas, using the electronic case filing system of 
the court.  I hereby certify that I have served all parties electronically or by another manner 
authorized by Federal Rule of Civil Procedure 5(b)(2).  
/s/ Brian W. Stoltz 
Brian W. Stoltz 
Assistant United States Attorney 
Case 4:22-cv-00915-P     Document 51     Filed 06/04/25      Page 4 of 4     PageID 451

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