Pfizer Motion for Leave to Intervene — PHMPT v. FDA

Record facts

U.S. District Court for the Northern District of Texas (Fort Worth Division) · No. 4:21-cv-01058-P · Doc. 40 · 2022-01-21 · Docket on CourtListener

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PFIZER INC.’S MOTION FOR LEAVE TO INTERVENE FOR A LIMITED PURPOSE  
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UNITED STATES DISTRICT COURT FOR THE  
NORTHERN DISTRICT OF TEXAS 
FORT WORTH DIVISION  
 
PUBLIC HEALTH AND MEDICAL 
PROFESSIONALS FOR 
TRANSPARENCY 
 
 
Plaintiff, 
 
v. 
 
FOOD AND DRUG  
ADMINISTRATION 
 
 
Defendant. 
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CASE NO. 4:21-CV-01058-P 
 
 
 
  
 
 
PFIZER INC.’S MOTION FOR LEAVE TO INTERVENE 
FOR A LIMITED PURPOSE 
 
 
Pursuant to Fed. R. Civ. P. 24(a) and (b), Pfizer Inc. (“Pfizer”) moves for leave to intervene 
for a limited purpose in the above-captioned case.  This litigation arises from Plaintiff’s request 
under the Freedom of Information Act (“FOIA”) for the Food and Drug Administration (“FDA”) 
to release information submitted by Pfizer in support of a biologics license application (“BLA”) 
for Pfizer-BioNTech’s COVID-19 vaccine (“the vaccine”).  Pfizer supports the public disclosure 
of the vast majority of this information, to promote transparency and the public’s confidence in 
the vaccine, and indeed Pfizer, FDA, and others already have made public extensive data and 
information about the vaccine.  Pfizer’s interest in intervening is to facilitate a rapid disclosure 
Case 4:21-cv-01058-P   Document 40   Filed 01/21/22    Page 1 of 3   PageID 1755
Case 4:21-cv-01058-P   Document 40   Filed 01/21/22    Page 1 of 3   PageID 1755

 
PFIZER INC.’S MOTION FOR LEAVE TO INTERVENE FOR A LIMITED PURPOSE  
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process while not compromising the statutorily-protected confidentiality of certain categories of 
information that Pfizer has provided to FDA as part of the BLA approval process.    
Because FDA has expressed concern about whether it can adequately review the volume 
of material in time to protect against the disclosure of confidential commercial information, Pfizer 
seeks leave to intervene, at the Court’s and Government’s suggestion, for the limited purpose of 
helping FDA and the Court ensure expeditious action as ordered by this Court and ensuring that 
Pfizer is informed of relevant developments in relation to the case.  Pfizer recognizes that it is the 
Government’s province to make the relevant determinations under FOIA, but Pfizer hopes that 
engaging in a dialogue with the Government where it has questions about Pfizer’s view regarding 
certain portions of the BLA will make it easier for the Government to meet the production schedule 
ordered by this Court. 
The accompanying Memorandum of Points and Authorities sets out why this motion 
should be granted.  A proposed order is submitted herewith as Exhibit 1.  A statement of interest 
is submitted herewith as Exhibit 2.   
 
Dated: January 21, 2022  
 
 
      Respectfully submitted, 
      /s/ Daniel L. Tobey 
 
 
 
 
Daniel L. Tobey 
 
State Bar No. 24048842 
 
DLA PIPER LLP (US) 
 
1900 N. Pearl St, Suite 2200 
 
Dallas, Texas 75201 
 
Telephone: (214) 743-4500  
 
Facsimile:  (214) 743-4545 
 
 
 
Ashley Allen Carr 
 
State Bar No. 24082619 
 
DLA PIPER LLP (US) 
 
303 Colorado Street, Suite 3000 
 
Austin, Texas 78701 
 
Telephone: (512) 457-7000 
 
Facsimile:  (512) 457-7001 
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PFIZER INC.’S MOTION FOR LEAVE TO INTERVENE FOR A LIMITED PURPOSE  
3 
 
 
Matthew A. Holian (pro hac vice forthcoming) 
 
DLA PIPER LLP (US) 
 
33 Arch Street, 26th Floor  
 
Boston, Massachusetts 02110-1447 
 
Telephone: (617) 406-6009 
 
Facsimile: (617) 406-6109  
Counsel for Proposed Intervenor Pfizer Inc. 
CERTIFICATE OF CONFERENCE 
I certify that on January 19, 2022, I conferred with counsel for Defendant regarding this Motion.  
Counsel for Defendant indicated that Defendant is unopposed to the relief sought herein.  I further 
certify that counsel for Pfizer (Matt Holian and Danny Tobey) conferred with Plaintiff’s counsel 
(Aaron Siri and Elizabeth Brehm) on the Motion by videoconference on January 20 and by email 
on January 20 and 21.  Agreement could not be reached because Plaintiff’s counsel stated 
Plaintiff’s position as follows:  “Plaintiff does not object to Pfizer moving to intervene, so long as 
Pfizer intends to only address decisions going forward and not to ask the Court to reconsider 
decisions it has already reached since any motion to intervene as to already adjudicated matters is 
untimely.”  Pfizer does not presently intend to move the Court to reconsider its January 6, 2022 
order, but Pfizer is not in a position at this time to waive its ability to do so if circumstances change 
such that there is good cause at a later time to do so.  Pfizer also disagrees with Plaintiff that its 
motion to intervene is untimely.  
      /s/ Daniel L. Tobey 
 
 
 
 
Daniel L. Tobey 
CERTIFICATE OF SERVICE 
I certify that on January 21, 2022, I electronically filed the foregoing Motion for Leave to 
Intervene using the CM/ECF system.  Notice of this filing will be sent by operation of the 
Court’s electronic filing system to all parties of record. 
      /s/ Daniel L. Tobey 
 
 
 
 
Daniel L. Tobey 
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Case 4:21-cv-01058-P   Document 40   Filed 01/21/22    Page 3 of 3   PageID 1757

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