Second Joint Report — PHMPT v. FDA

Record facts

U.S. District Court for the Northern District of Texas · No. 4:21-cv-01058-P · Doc. 20 · 2021-11-15 · Docket on CourtListener

Full text

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IN THE UNITED STATES DISTRICT COURT 
NORTHERN DISTRICT OF TEXAS 
 
 
PUBLIC HEALTH AND MEDICAL 
PROFESSIONALS FOR TRANSPARENCY, 
 
 
Plaintiff, 
 
-against- 
 
FOOD AND DRUG ADMINISTRATION, 
 
 
Defendant. 
 
 
 
 
 
Civil Action No. 4:21-cv-01058-P 
 
 
 
SECOND JOINT REPORT  
 
Plaintiff, Public Health and Medical Professionals for Transparency (“Plaintiff”), by and 
through its attorneys, and Defendant, the U.S. Food and Drug Administration (“Defendant or 
“FDA”), by and through its attorney, hereby submit this Joint Report in compliance with the 
Court’s Order of November 10, 2021, ECF No. 19 (the “Order”):   
1. 
The Order asked the parties to “appraise the Court of whether a scheduling 
conference is needed” and if not to “propose[] deadlines for an expedited briefing schedule, if 
necessary.”    
2. 
Defendant’s Position: A scheduling conference is needed with the Court in order 
to set a schedule for the processing of records in response to Plaintiff’s Freedom of Information 
Act (“FOIA”) request.  Setting a processing schedule does not go to the merits of the case, but 
instead sets the schedule for the necessary deadlines to govern a FOIA case.  The processing 
schedule serves as an important precursor to future deadlines in the case, including scheduling for 
dispositive motions. 
In FOIA cases, a FOIA requestor typically files suit after it has submitted a FOIA request 
to an agency and the agency has not yet processed and produced all responsive records to the 
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requestor.  5 U.S.C. § 552(a)(4)(B).  Once a case is filed and the government has answered the 
complaint, the parties usually negotiate a schedule by which the government will search for, 
process, and produce records responsive to the plaintiff’s FOIA request.  If the parties are unable 
to agree upon a schedule, courts typically enter a processing schedule after considering arguments 
for each party’s proposed schedule that were presented in a status report or at a scheduling 
conference.   
A processing schedule is necessary because many different types of information are exempt 
from the FOIA, such that the government must redact that information before providing responsive 
records to the plaintiff.  See 5 U.S.C. § 552(b)(1)–(b)(9).  Reviewing and redacting records for 
exempt information is a time-consuming process that often requires government information 
specialists to review each page line-by-line.  When a party requests a large amount of records, like 
Plaintiff did here, courts typically set a schedule whereby the processing and production of the 
non-exempt portions of records is made on a rolling basis.   
After the government has completed processing and producing the non-exempt portions of 
responsive records to the plaintiff, the parties typically confer as to whether the plaintiff intends to 
challenge the adequacy of the government’s search for records or any of the redactions taken to 
protect the disclosure of exempt material.  If the parties have a dispute over the search or the 
exemptions, the parties typically confer and propose a schedule for summary judgment briefing.  
Setting a summary judgment schedule before the completion of the production of records is 
inefficient for the parties and the Court, as it results in piecemeal briefing and consideration of the 
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merits of the case.  Summary judgment briefing in a FOIA case is not the appropriate vehicle to 
set a schedule for the release of records.1 
In this case, FDA has assessed that there are more than 329,000 pages potentially 
responsive to Plaintiff’s FOIA request.  (This page count is under-inclusive of the material 
responsive to the request, as it does not include certain types of records that cannot be meaningfully 
paginated, such as data captured in spreadsheets that contain thousands of rows of data.)  The 
parties have conferred in good faith concerning a processing schedule, but have been unable to 
reach agreement for the reasons set forth in the parties’ Joint Report.  See ECF No. 18. 
Defendant respectfully requests a scheduling conference with the Court for the Court to set 
a schedule for the processing of documents.  Defendant proposed a processing schedule in the 
Joint Report and resubmits it here for ease of reference.  FDA proposes to process and produce the 
non-exempt portions of the following records by the following dates: 
• November 17:  
o From Section 5.2 of the Biologics License Application (“BLA”) file: 
▪ The Tabular Listing 
▪ The Listing of Clinical Sites 
o The Reports of Postmarketing Experience from Section 5.3.6 of the BLA 
file 
o One SAS file.2   
 
1 Nor is establishing a briefing schedule for “expedited production” necessary.  Any production schedule established 
as part of a scheduling conference with the Court will inherently resolve any questions related to the rate of the 
agency’s production. 
2 Plaintiff has requested to receive the SAS files in their native format.  FDA customarily converts SAS files to PDF 
files because PDFs can be redacted to prevent the release of non-exempt information.  However, FDA is willing to 
produce SAS files to Plaintiff (if it is feasible for FDA to do so) with the parties’ understanding that FDA may have 
to delete, rather than redact, exempt information from those files to prevent disclosure of exempted information.   
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• December 1: remainder of section 5.2 of the BLA file. 
After the December 1 production, FDA proposes to work through the list of documents that 
Plaintiff requested FDA prioritize for production in order of priority and process and release the 
non-exempt portions of those records to Plaintiff on a rolling basis.  FDA proposes to process and 
produce the non-exempt portions of responsive records at a rate of 500 pages per month.  This rate 
is consistent with processing schedules entered by courts across the country in FOIA cases.3 
 
Plaintiff’s request (as set forth below) that FDA process and produce the non-exempt 
portions of more than 329,000 pages in four months would force FDA to process more than 80,000 
pages per month.  Undersigned counsel is not aware of any court ever granting such a request.  The 
Court should decline to enter Plaintiff’s schedule for numerous reasons.  
 
First, “[r]equiring the agency to process and produce these materials under an abbreviated 
deadline raises a significant risk of inadvertent disclosure of records properly subject to exemption 
under FOIA.”  Daily Caller v. Dep’t of State, 152 F. Supp. 3d 1, 14 (D.D.C. 2015).  Plaintiff has 
requested records that comprise information submitted by the vaccine sponsor (Pfizer-BioNTech).  
From FDA’s experience with other FOIA requests, such records can be expected to contain both 
 
3 See, e.g., Documented NY v. U.S. Dep’t of State, No. 20 Civ. 1946 (AJN) (S.D.N.Y.) Dkt. 26 p.2 (denying plaintiff’s 
processing rate demand of 2,500 pages per month and adopting Department of State’s proposed 300 pages per month); 
NYCLU v. Admin. for Children & Families, No. 20 Civ. 183 (MKV), Dkt. No. 30 (S.D.N.Y. May 5, 2020) (400 pages 
per month); Color of Change v. U.S. Dep’t of Homeland Sec., 325 F. Supp. 3d 447, 451 (S.D.N.Y. 2018) (500 pages 
per month); Davis v. U.S. Dep’t of Homeland Sec., No. 11-cv-203 (ARR) (VMS), 2013 WL 3288418, at *1 (E.D.N.Y. 
June 27, 2013) (500 pages per month); Blakeney v. FBI, No. 17-cv-2288 (BAH), 2019 WL 450678, at *2 (D.D.C. Feb. 
5, 2019) (500 pages per month); Colbert v. FBI, No. 16 Civ. 1790 (DLF), 2018 WL 6299966, at *3 (D.D.C. Sept. 3, 
2018) (500 pages per month); Republican Nat’l Comm. v. U.S. Dep’t of State, No. 16 Civ. 486 (JEB), 2016 WL 
9244625, at *1 (D.D.C. Sept. 16, 2016) (500 pages per month); Energy & Env’t Legal Inst. v. U.S. Dep’t of State, No. 
17 Civ. 340 (D.D.C.), Minute Order of August 22, 2017 (300 pages per month); Judicial Watch, Inc. v. U.S. Dep’t of 
State, No. 17 Civ. 205 (D.D.C.), Minute Order of June 30, 2017 (300 pages every four weeks); Am. Ctr. for Law & 
Justice v. U.S. Dep’t of State, No. 16 Civ. 2516 (D.D.C.), Minute Order of June 27, 2017 (process 400 pages per 
month); Citizens United v. U.S. Dep’t of State, No. 16 Civ. 67 (D.D.C.), Dkt. 17 at 3 (declining “to adopt Plaintiff’s 
proposed production order of 2000 pages per month” and instead holding State “to its 300-page commitment”); 
Freedom Watch v. Bureau of Land Mgmt., No. 16 Civ. 2320 (D.D.C.), Minute Order of June 13, 2017 (500 pages 
every 30 days); Citizens United v. U.S. Dep’t of State, No. 15 Civ. 1720 (D.D.C.), Dkt. 11 ¶ 10 (500 pages every four 
weeks); Judicial Watch, Inc. v. U.S. Dep’t of State, No. 15 Civ. 687 (D.D.C.), Minute Order of April 4, 2017 (500 
pages per month). 
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confidential business and trade secret information of Pfizer or BioNTech and personal privacy 
information of patients who participated in clinical trials.  FDA is required to protect certain 
information under the law and this type of information is exempt from production under the FOIA.  
See 5 U.S.C. § 552(b)(4), (b)(6); F.B.I. v. Abramson, 456 U.S. 615, 621 (1982) (“Congress realized 
that legitimate governmental and private interests could be harmed by release of certain types of 
information and provided nine specific exemptions under which disclosure could be refused.”).  
To ensure protection of this information, and other information subject to withholding under the 
FOIA exemptions, FDA must carefully review and, if necessary, redact exempt information on a 
line-by-line basis.  See Daily Caller, 152 F. Supp. 3d at 14 (stating that the government has a 
“responsibility” when processing FOIA requests to “safeguard[] potentially sensitive 
information”).  This type of review for more than 329,000 pages will necessarily require time if 
the agency is going to be able to perform the careful analysis necessary to protect sensitive 
information. 
 
Second, the FDA does not have the personnel or resources in its FOIA office to process 
Plaintiff’s FOIA request at a rate of more than 80,000 pages per month.  Plaintiff’s FOIA request 
is being processed by the Access Litigation and Freedom of Information Branch (the “Branch”) in 
FDA’s Center for Biologics Evaluation and Research (“CBER”).  The Branch has a total of ten 
employees, including the director and two trainees.  It is currently responsible for processing a 
total of approximately 400 currently pending FOIA requests, including Plaintiff’s. CBER is 
currently involved in 6 active FOIA litigation matters.  By processing and making interim 
responses based on 500-page increments, FDA will be able to provide more pages to more 
requesters, thus avoiding a system where a few large requests monopolize finite processing 
resources and where fewer requesters’ requests are being fulfilled.  Simply put, processing 
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resources are finite.  Increasing the volume to more than 80,000 pages per month (if such rate is 
even possible – and it likely is not), as Plaintiff requests, would result in Plaintiff monopolizing 
essentially all of FDA’s resources and leaving little resources to process other FOIA requests.  
Indeed, the D.C. Circuit has recognized that another agency’s policy of processing 500 pages per 
request per month “serves to promote efficient responses to a larger number of requesters.”  Nat’l 
Sec. Counselors v. Dep’t of Justice, 848 F.3d 467, 471–72 (D.C. Cir. 2017); see also Elec. Privacy 
Info. Ctr. v. Dep’t of Justice, 15 F. Supp. 3d 32, 47 (D.D.C. 2014) (denying motion for preliminary 
injunction requesting immediate production of documents pursuant to FOIA request and noting 
that allowing the plaintiff “to jump to the head of the line would upset the agency’s processes and 
be detrimental to the other expedited requesters”); Daily Caller, 152 F. Supp. 3d at 14 (stating that 
“the plaintiff’s effort to jump to the head of the FOIA processing line would work a significant 
burden on both the agency and numerous interested parties”). 
Third, the Court should flatly reject Plaintiff’s specious argument that because the scientists 
reviewing Pfizer’s Biologics License Application could do so on an expedited timeframe, the 
government information specialists should be able to do so in the same period of time.  As should 
be apparent, the review conducted by FDA scientists when considering to approve a product is 
entirely different from the review conducted by FDA government information specialists when 
considering whether FDA must keep certain information confidential.  Moreover, FDA’s FOIA 
office does not have nearly the same level of personnel or resources dedicated to process FOIA 
requests as FDA has marshaled to review license applications for live-saving products in the 
middle of a pandemic. 
Fourth, contrary to Plaintiff’s argument, FDA’s regulations do not require or suggest that 
FDA will release all publicly releasable data immediately after a biologics license application is 
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approved.  When read in context, it is clear that FDA’s regulations establish when information in 
a biological product file is held in strict confidence by the agency and when certain data can be 
released to the public, for instance in response to standard processing of a request submitted under 
the Freedom of Information Act.  See generally 21 C.F.R. § 601.51.  Put another way, the 
regulations establish the point in time when records that may previously have been unavailable for 
public disclosure lose their status as confidential and thus become available for public release 
“immediately” upon occurrence of the triggering event.  Specifically, under 21 C.F.R. § 601.51, 
the existence of a biological product file will not be disclosed by FDA prior to BLA approval 
unless it has been previously disclosed or acknowledged, and no data or information in that file is 
available for public disclosure.  21 C.F.R. § 601.51(b, c).  If the existence of the biological product 
file has been acknowledged before a license has been issued, FDA generally still will not make 
information and data in the file available for public disclosure prior to issuance of a BLA 
license.  21 C.F.R. § 601.51(d).  Once a license has been issued, however, certain data and 
information in the biological product file become “immediately” available for public 
disclosure.  21 C.F.R. § 601.51(e).  That means that if a properly submitted FOIA request is 
received for data and information listed in 21 C.F.R. § 601.51(e), FDA may publicly release such 
information in response to such request, without need for additional agency action to reclassify as 
publicly releasable data and information that had previously been deemed confidential under this 
regulation. 
Fifth, although Plaintiff takes issue with the amount of time it will take to process 329,000 
pages at a rate of 500 pages per month, such a result is due to its own broad FOIA request.  Courts 
do not waiver from the standard 500 page per month processing rate even when a FOIA request 
would take years to process.  See, e.g., Colbert v. F.B.I., No. 16-CV-1790 (DLF), 2018 WL 
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6299966, at *3 (D.D.C. Sept. 3, 2018) (permitting a processing rate of 500 pages per month for 
71,000 responsive records).  FDA has invited Plaintiff to narrow its request by specifying records 
it no longer wants FDA to process and release, and Plaintiff has declined to do so.  If Plaintiff 
decides to request fewer records, then FDA will be able to complete its processing at an earlier 
date.   
 
Finally, this case is not about a vaccine mandate or whether Pfizer can be held liable.  This 
is a FOIA case where the only relevant issue at this stage in the litigation is setting a reasonable 
processing schedule.  FDA’s proposed schedule of 500 pages per month is consistent with 
schedules set by courts across the country, including in cases where the underlying records were 
of national significance.  It adequately balances the interests of the Plaintiff in responsive records 
with the interests of the vaccine sponsor in the protection of its confidential information, the 
interests of clinical trial participants in the protection of their personal privacy information, and 
the interests of other FOIA requesters whose requests are being processed alongside Plaintiff’s. 
3. 
Plaintiff’s Position: Plaintiff agrees with the Defendant’s position that the Court 
may enter a production schedule based on the arguments in this Joint Report or do so at a 
conference.  Plaintiff seeks the records submitted to the FDA by Pfizer to license its COVID-19 
vaccine (the “FOIA request”)4 and requests an order requiring the FDA to produce all documents 
 
4 The FOIA request requested: “All data and information for the Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e)4 
with the exception of publicly available reports on the Vaccine Adverse Events Reporting System.4”  The CFR provision 
referenced in the FOIA request provides, in relevant part, as follows: “After a license has been issued, the following data 
and information in the biological product file are immediately available for public disclosure unless extraordinary 
circumstances are shown: (1) All safety and effectiveness data and information. (2) A protocol for a test or study . . .   (3) 
Adverse reaction reports. . .  (4) A list of all active ingredients and any inactive ingredients . . .   (5) An assay method or 
other analytical method . . .   (6) All correspondence and written summaries of oral discussions relating to the biological 
product file . . .  (7)  All records showing the manufacturer’s testing of a particular lot . . .  (8) All records showing the 
testing of and action on a particular lot by the [FDA].”   The FOIA request also explained that “For the avoidance of 
doubt, the FOIA Request includes but is not limited to all of the data and information in the biological product file, as 
defined in 21 C.F.R. § 601.51(a), for the Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e) with the exception of 
publicly available reports on the Vaccine Adverse Events Reporting System.” 
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responsive to its FOIA request no later than March 3, 2022.  This 108-day period is the same 
amount of time it took the FDA to review the responsive documents for the far more intricate task 
of licensing Pfizer’s Covid-19 vaccine (the “Pfizer vaccine”).   
Plaintiff is an organization comprised of over 30 accomplished academics, professors, and 
scientists from the medical schools and related departments of our most prestigious universities, 
including Yale, Harvard, UCLA, and Brown.  These academics and scientists represent a cross 
section of every discipline relevant to the licensure of the Pfizer vaccine and include many of the 
best our country has to offer when it comes to reviewing and assessing the appropriateness and 
validity of the FDA’s decision-making in licensing this product.   
The ability of a majority of Americans to participate in civil society, and even exercise 
basic liberty rights, are now contingent on receiving this product.  For example, the White House’s 
recent Covid-19 Action Plan5 and executive orders6 have made receipt of this product a condition 
of employment7 for more than 6 million federal workers and contractors,8 22 million healthcare 
professionals,9 84 million private sector employees,10 and the enlisted and reserve members of our 
 
5 https://www.whitehouse.gov/covidplan/#testing-masking (last visited November 15, 2021). 
6 
See 
https://www.whitehouse.gov/briefing-room/presidential-actions/2021/09/09/executive-order-on-ensuring-
adequate-covid-safety-protocols-for-federal-contractors/ (Executive Order of Ensuring Adequate COVID Safety 
Protocols for Federal Contractors) (last visited November 15, 2021); https://www.whitehouse.gov/briefing-
room/presidential-actions/2021/09/09/executive-order-on-requiring-coronavirus-disease-2019-vaccination-for-
federal-employees/ (Executive Order on Requiring Coronavirus Disease 2019 Vaccination for Federal Employees) 
(last visited November 15, 2021). 
7 See, e.g., https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.501 (Emergency Temporary 
Standard requiring employers with 100 or more employees to implement vaccination mandates) (last visited 
November 12, 2021); https://www.whitehouse.gov/briefing-room/presidential-actions/2021/09/09/executive-order-
on-requiring-coronavirus-disease-2019-vaccination-for-federal-employees/ 
(Executive 
Order 
on 
Requiring 
Coronavirus Disease 2019 Vaccination for Federal Employees) (last visited November 12, 2021). 
8 
https://thehill.com/opinion/finance/438242-the-federal-government-is-the-largest-employer-in-the-nation 
(last 
visited November 12, 2021). 
9 
https://www.census.gov/library/stories/2021/04/who-are-our-health-care-workers.html#:~:text=There%20were%
2022%20million%20workers,American%20Community%20Survey%20(ACS) (last visited November 12, 2021). 
10 
https://www.cnbc.com/2021/11/04/osha-federal-vaccine-mandate-covers-84-million-workerswhat-to-know.html 
(last visited November 12, 2021). 
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armed forces.11  There are few whose livelihood, education, service, and participation in civil society 
are not contingent on a government requirement to receive this product.  On this basis alone, basic 
liberty and government transparency demand that the documents and data submitted by Pfizer to 
license this product be made available to Plaintiff and the public forthwith, precisely as contemplated 
by federal regulations.12  
The acute need for transparency regarding this product is heightened by the fact that the 
secretary of Health and Human Services (“HHS”), the FDA’s parent department, has granted 
Pfizer complete immunity from financial liability for any injury caused by its product.  If injured 
-- including suffering one of the injuries even federal health authorities admit occur from Pfizer’s 
product -- the injured individual effectively has no recourse.  Pursuant to the declaration from the 
secretary of HHS, Pfizer cannot be sued by anyone receiving this product for any injury.  42 U.S.C. 
§ 247d-6d.  Pfizer also cannot be sued for willful misconduct regarding this product unless HHS, 
which has been promoting this product, agrees to bring such a claim.  42 U.S.C. § 247d-6d(c)(5).13   
It should not be that the public is deprived accessing the documents and data submitted by Pfizer 
to license this product when at the same time the public are being mandated to receive this product 
with no ability to sue Pfizer for compensation if they suffer any adverse reaction.   
The FDA has proposed to produce 500 pages per month which, based on its calculated 
number of pages, would mean it would complete its production in nearly 55 years – the year 2076.  
Until the entire body of documents provided by Pfizer to the FDA are made available, an 
 
11 
https://www.americaspromise.org/us-military-demographics#:~:text=Military%20Service%20Member%20Data
,were%202.1%20active%20duty%20members (last visited November 12, 2021). 
12 See 21 CFR § 601.51(e). 
13 Reports have recently surfaced that the FDA was aware of concerns about unsound practices in connection with 
clinical trials for the Pfizer Vaccine, but that FDA failed to properly investigate these claims. 
https://www.bmj.com/content/375/bmj.n2635 (last visited November 12, 2021).  
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appropriate analysis by the independent scientists that are members of Plaintiff is not possible. 
Would the FDA agree to review and license this product without all the documents?  Of course 
not.  These independent, world-renowned scientists should be provided the same forthwith.  
The entire purpose of the FOIA is to assure government transparency.  It is difficult to 
imagine a greater need for transparency than immediate disclosure of the documents relied upon 
by the FDA to license a product that is now being mandated to over 100 million Americans under 
penalty of losing their careers, their income, their military service status, and far worse.  
It took the FDA precisely 108 days from when Pfizer started producing the records for 
licensure on May 7, 2021,14 to when the product was licensed on August 23, 2021.15  We assume, 
as the FDA has stated, that it conducted an intense, robust, thorough and complete review and 
analysis of those documents in order to assure that the Pfizer vaccine was safe and effective for 
licensure.  The FDA now has an equally important task of making those documents available to 
the Plaintiff in this case and the public at large in at least the same timeframe.  
The FDA’s own regulations envision and reflect upon the importance of making this 
information public as soon as a vaccine is licensed.  Its regulations provide that it is to make 
“immediately available” all documents underlying licensure of a vaccine.  21 C.F.R. § 601.51(e). 
The FDA knew the intense public interest in that data and information.  It should have been 
preparing to release it simultaneously with the licensure.  Instead, it has done the opposite.  Despite 
the passage of 84 days since licensure and 192 days since Pfizer started producing the records for 
 
14 
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-initiate-rolling-submission-
biologics (Pfizer announces that it initiated rolling submission of its biologics license application on May 7, 2021) 
(last visited November 12, 2021). 
15 https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine (FDA announces that 
it approved Pfizer’s COVID-19 vaccine on August 23, 2021) (last visited November 12, 2021). 
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licensure, the FDA has not released a single document submitted by Pfizer for the licensure of its 
Covid-19 vaccine.  Not one page.   
Mandates of this liability-free product are ongoing and expanding as we debate in this Joint 
Report.  School-age children are now being mandated to take this product.16  Even 108 days from 
today to produce is far too long, hence Plaintiff respectfully urges that March 3, 2022 be set as the 
absolute outside date by which the FDA be compelled to produce these documents.  The FDA is 
an organization comprised of more than 18,000 people17 with a budget of $6 billion.18  It has itself 
said that there is nothing more important than the licensure of this vaccine and being transparent 
about this vaccine.  This request is precisely why the need for transparency is so critical and why 
Congress enacted FOIA.  If the FDA claims its obligations under FOIA are too burdensome, it 
should take its complaints to Congress – not this Court.   
For the Americans that will lose their job, income, career, military status, education, or 
worse, for refusing a federal mandate requiring this product, they do not get to argue that it is too 
burdensome to comply with federal law.  That is not an excuse that individuals get to make when 
a federal law requires them to do something.  The FDA should similarly be afforded no such safe 
harbor.  Certainly not on an issue this important.  Again, if the FDA finds complying with federal 
law burdensome, its recourse is with Congress. 
In any event, the FDA should welcome making these documents available to the Plaintiff 
if it is confident in the analysis and review it conducted.  The fact that it has fought tooth and nail 
 
16 See, e.g., https://www.nbcsandiego.com/news/local/san-diego-unified-school-district-vaccine-mandate/2729909/.  
17 https://www.fda.gov/about-fda/fda-basics/how-many-people-are-employed-fda-and-what-areas-do-they-work (last 
visited November 12, 2021). 
18 https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance (last visited November 12, 2021). 
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and taken such an absurd and unconscionable position of waiting until the year 2076 to complete 
the production further heightens the grave need to have these documents produced forthwith.  
Plaintiff respectfully requests that the Court enter an order requiring the FDA to produce 
all documents and data submitted by Pfizer on a rolling basis such that all of it shall be produced 
on or before March 3, 2022, which is 108 days from today.  To require less is to render FOIA 
meaningless, the FDA’s promise of transparency a lie, and to send a signal to every American that 
while the federal executive branch is shielding Pfizer from any liability for injuries from its product 
and requiring employers, schools, hospitals and the military to expel those that don’t receive this 
product, it is protecting the very documents Pfizer provided to our taxpayer-funded health agency 
to obtain licensure to be able to sell this product.  That simply should not be and highlights why 
FOIA and equity demand the relief Plaintiff requests herein.  
 
 
Dated:  November 15, 2021 
 
 
 
SIRI & GLIMSTAD LLP 
 
/s/ Aaron Siri 
Aaron Siri, NY Bar No. 4321790 
Elizabeth A. Brehm, NY Bar No. 4660353 
Gabrielle G. Palmer, CO Bar No. 48948 
200 Park Avenue 
17th Floor 
New York, New York 10166 
Tel: (212) 532-1091 
Fax: (646) 417-5967 
aaron@sirillp.com 
ebrehm@sirillp.com 
gpalmer@sirillp.com 
 
 
 
 
 
 
Case 4:21-cv-01058-P   Document 20   Filed 11/15/21    Page 13 of 14   PageID 217
Case 4:21-cv-01058-P   Document 20   Filed 11/15/21    Page 13 of 14   PageID 217

Page 14 of 14 
 
HOWIE LAW, PC 
 
/s/ John Howie 
John Howie 
Texas Bar Number: 24027239  
2608 Hibernia Street 
Dallas, Texas 75204 
Tel: (214) 622-6340 
jhowie@howielaw.net 
 
Attorneys for Plaintiff 
  
 
 
BRIAN M. BOYNTON  
Acting Assistant Attorney General  
Civil Division  
 
ELIZABETH J. SHAPIRO  
Deputy Director  
Federal Programs Branch  
 
/s/ Courtney D. Enlow 
COURTNEY D. ENLOW  
Trial Attorney  
United States Department of Justice  
Civil Division, Federal Programs Branch  
1100 L Street, N.W.  
Room 12102  
Washington, D.C. 20005  
Tel: (202) 616-8467 
Email: courtney.d.enlow@usdoj.gov 
 
Counsel for Defendant 
 
 
 
 
 
 
 
  
Case 4:21-cv-01058-P   Document 20   Filed 11/15/21    Page 14 of 14   PageID 218
Case 4:21-cv-01058-P   Document 20   Filed 11/15/21    Page 14 of 14   PageID 218

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