Joint status report — PHMPT v. FDA

Record facts

U.S. District Court for the Northern District of Texas · No. 4:21-cv-01058-P · Doc. 65 · 2022-12-24 · Docket on CourtListener

Summary

A joint status report filed December 24, 2022 in Public Health and Medical Professionals for Transparency v. United States Food and Drug Administration, Civil Action No. 4:21-cv-01058-P, in the U.S. District Court for the Northern District of Texas, as Doc. 65. The report lists FDA productions of 55,474 pages on October 3, 2022, 55,161 pages on November 1, 2022 and 55,139 pages on December 1, 2022. It states that FDA has banked 86,388 pages and expects to produce a minimum of 55,000 additional pages on or before January 3, 2023. FDA states it cannot yet estimate the remaining page count or completion date because it is still assessing the scope of records in the Comirnaty biological product file. The parties will submit another joint status report within 90 days; it is signed by counsel Elizabeth A. Brehm for plaintiff and Antonia Konkoly for FDA.

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IN THE UNITED STATES DISTRICT COURT 
FOR THE NORTHERN DISTRICT OF TEXAS 
 
) 
PUBLIC HEALTH AND MEDICAL 
) 
PROFESSIONALS FOR 
) 
TRANSPARENCY, 
) 
) 
Plaintiff, 
) 
) 
v. 
) 
Civil Action No. 4:21-cv-01058-P 
) 
UNITED STATES FOOD AND DRUG ) 
ADMINISTRATION, 
) 
) 
Defendant. 
) 
  
  ) 
 
 
JOINT STATUS REPORT 
 
Pursuant to the Court’s Order dated January 6, 2022 (Dkt. No. 35), the parties hereby 
submit the instant Joint Status Report (“JSR”). Consistent with this Court’s Order of February 2, 
2022 (Dkt. No. 56), and in the interim since the parties’ last JSR, filed on September 28, 2022 
(Dkt. No. 64), the U.S. Food and Drug Administration (“FDA”) has made the following additional 
productions: 
• An October 3, 2022 production consisting of 55,474 pages of responsive records;  
• A November 1, 2022 production consisting of 55,161 pages of responsive records; 
and 
• A December 1, 2022 production consisting of 55,139 pages of responsive records.  
 
 
 
Case 4:21-cv-01058-P   Document 65   Filed 12/24/22    Page 1 of 3   PageID 2281

 
 
Pursuant to the Court’s Order dated February 2, 2022 (Dkt. No. 56), FDA may “bank” any 
pages produced in excess of its monthly quota. To date, FDA has banked 86,388 pages. FDA 
expects to produce a minimum of 55,000 additional pages on or before January 3, 2023.  
On December 22, 2022, in anticipation of this status report, Plaintiff asked FDA to provide 
an estimated remaining page count and/or estimated completion date of production.  FDA 
responded that it is not presently in a position to provide an estimated remaining page count or 
estimated completion date because it is still assessing the scope of records incorporated into the 
Comirnaty biological product file.  FDA expects to be better positioned to provide these estimates 
by the date of the next joint status report (in approximately 90 days) and will provide its best 
estimates at that time. 
The parties will submit another joint status report within 90 days. 
Dated: December 24, 2022 
 
Respectfully submitted, 
 
SIRI & GLIMSTAD LLP 
 
/s/ Elizabeth A. Brehm__________ 
Aaron Siri, NY Bar No. 4321790  
Elizabeth A. Brehm, NY Bar No. 4660353 
200 Park Avenue 
    17th Floor 
New York, New York 10166 
Tel: (212) 532-1091 
aaron@sirillp.com  
ebrehm@sirillp.com    
 
Attorneys for Plaintiff 
 
BRIAN M. BOYNTON 
Principal Deputy Assistant 
Attorney General 
Civil Division 
 
ELIZABETH J. SHAPIRO 
   Deputy Director 
   Federal Programs Branch 
 
/s/ Antonia Konkoly 
 
ANTONIA KONKOLY 
   Trial Attorney 
United States Department of Justice 
Civil Division, Federal Programs 
Branch 
1100 L Street NW 
   Washington, D.C. 20005 
   Tel: (202) 514-2395 
   Email: antonia.konkoly@usdoj.gov 
 
Attorneys for Defendant 
Case 4:21-cv-01058-P   Document 65   Filed 12/24/22    Page 2 of 3   PageID 2282

 
 
 
CERTIFICATE OF SERVICE 
 
I hereby certify that on December 24, 2022, I electronically transmitted the foregoing to 
the parties and the clerk of court for the United States District Court for the Northern District of 
Texas using the CM/ECF filing system. 
 
 
 
Annalise R. Beube 
Law Clerk 
Siri & Glimstad LLP 
 
 
 
Case 4:21-cv-01058-P   Document 65   Filed 12/24/22    Page 3 of 3   PageID 2283

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