Complaint for Declaratory and Injunctive Relief — PHMPT v. FDA

Record facts

U.S. District Court for the Northern District of Texas · No. 4:21-cv-01058-P · Doc. 1 · 2021-09-16 · Docket on CourtListener

Full text

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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. ____________ 
 
 
 
COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF 
 
Plaintiff, as for its Complaint regarding a Freedom of Information Act request against the 
above-captioned Defendant, alleges as follows: 
INTRODUCTION 
1. 
Until only a few weeks ago, all coronavirus vaccines available in the United States 
were only authorized for emergency use by the U.S. Food and Drug Administration (the “FDA”).1  
2. 
On August 23, 2021, the FDA approved the Pfizer-BioNTech COVID-19 Vaccine, 
marketed as Comirnaty (the “Pfizer Vaccine”) for individuals 16 years of age and older.2 
3. 
Although the FDA asserts that the Pfizer Vaccine “meets the high standards for 
safety, effectiveness, and manufacturing quality the FDA requires of an approved product[,]”3 
numerous public health officials, media outlets, journalists, scientists, politicians, public figures, 
and others with large social or media platforms have publicly raised questions regarding the 
sufficiency of the data and information, the adequacy of the review, and the appropriateness of the 
 
1 https://www.bmj.com/content/373/bmj.n1244 (last visited 9/5/2021). 
2 https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine (last visited 9/5/2021). 
3Id. 
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analyses relied upon by the FDA to license the Pfizer Vaccine. 
4. 
PHMPT is an organization made up of public health professionals, medical 
professionals, scientists, and journalists.  PHMPT exists for the sole purpose of disseminating to 
the public the data and information in the biological product files for each of the COVID-19 
vaccines.   
5. 
In furtherance of its mission, and in an effort to ensure that the FDA acts in 
furtherance of its commitment to transparency,4 PHMPT seeks to obtain the data and information 
relied upon by the FDA to license the Pfizer Vaccine.  The importance of releasing to the public 
this information is also recognized under federal law which provides that: “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 . . .”    21 C.F.R. § 601.51(e). 
6. 
PHMPT therefore issued a request to the FDA pursuant to the Freedom of 
Information Act (5 U.S.C. § 552, as amended) (“FOIA”) for “[a]ll data and information for the 
Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e)5 with the exception of publicly available 
reports on the Vaccine Adverse Events Reporting System.6” (the “FOIA Request”).   
7. 
The medical and scientific community and the public have a substantial interest in 
reviewing the data and information underlying the FDA’s approval of the Pfizer Vaccine.  
 
4 https://www.fda.gov/about-fda/transparency (last visited 9/5/2021). 
5 21 C.F.R. § 601.51(e) provides that after a biological product is licensed, the following information shall be made 
available for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data and 
information. (2) A protocol for a test or study . . . .  (3) Adverse reaction reports, product experience reports, consumer 
complaints, and other similar data and information . . . . (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].” 
6 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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Reviewing this information will settle the ongoing public debate regarding the adequacy of the 
FDA’s review process.  Releasing this data should also confirm the FDA’s conclusion that the 
Pfizer Vaccine is safe and effective and, thus, increase confidence in the Pfizer Vaccine.   The 
public’s need for this information is urgent given the fact that COVID-19 vaccines are being 
mandated to individuals across the country by federal, state, and local governments as well as 
private businesses.  
8. 
In an effort to disseminate the requested information to the public as expeditiously 
as possible, given the time sensitive nature of the issue, PHMPT requested expedited processing 
of the FOIA Request pursuant to 5 U.S.C. § 552(a)(6)(E)(v)(II). 
9. 
On September 9, 2021, the FDA denied PHMPT’s request for expedited processing 
on the basis that PHMPT did “not demonstrate[] a compelling need that involves an imminent 
threat to the life or physical safety of an individual” or “that there exists an urgency to inform the 
public concerning actual or alleged Federal Government activity.”  PHMPT brings this action to 
challenge the FDA’s determination and seeks an order compelling the FDA to produce responsive 
records on an expedited basis.  
PARTIES 
10. 
Public Health and Medical Professionals for Transparency is a not-for-profit 
organization with an office located at 1090 Texan Trail, Suite 534, Fort Worth, Texas, 76051. 
11. 
PHMPT’s members include: 
a. 
Aaron Kheriaty, MD 
 
Professor of Psychiatry, UCI School of Medicine 
 
Director, Medical Ethics Program, UCI Health 
b. 
Harvey Risch, MD, PhD 
 
Professor of Epidemiology 
 
Yale School of Public Health 
c. 
Peter A. McCullough, MD, MPH, FACP, FACC,  
FCCP, FAHA, FNKF, FNLA, FCRSA 
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d. 
Carole H Browner, PhD, MPH 
 
Distinguished Research Professor 
 
UCLA David Geffen School of Medicine 
e. 
Peter Doshi, PhD 
 
Associate Professor, Pharmaceutical Health Services Research 
 
University of Maryland School of Pharmacy 
 
Baltimore, Maryland, U.S.A. 
f. 
Linda Wastila, BSPharm, MSPH, PhD 
 
Professor, Pharmaceutical Health Services Research 
 
University of Maryland School of Pharmacy 
g. 
Andrew Bostom, MD, MS 
 
Associate Professor of Family Medicine (Research) 
 
The Warren Alpert Medical School of Brown University 
h. 
Erick H. Turner, MD 
 
Associate Professor 
 
Oregon Health & Science University 
i. 
Aditi Bhargava, PhD 
 
Professor Emerita 
 
Department of ObGyn and Reproductive Sciences University of California 
 
San Francisco 
j. 
Joseph A. Ladapo, MD, PhD 
 
Associate Professor of Medicine 
 
Division of General Internal Medicine and Health Services Research 
 
David Geffen School of Medicine at UCLA 
k. 
Gabe Vorobiof, MD FACC FASE 
 
Director, Adult Non-Invasive Cardiology Laboratories 
 
UCLA Cardiovascular Center 
 
Associate Clinical Professor of Medicine 
 
David Geffen School of Medicine at UCLA 
l. 
Donald W. Light, PhD 
 
Professor of Comparative Health Policy and Psychiatry 
 
Rowan University School of Osteopathic Medicine 
 
Glassboro, New Jersey, U.S.A. 
m. 
Allyson M Pollock, MBChB, FRCPH, FRCP (Ed) FRCGP 
 
Clinical Professor of Public Health 
 
Institute of Health and Society, Newcastle University 
 
Newcastle upon Tyne, United Kingdom 
n. 
Anthony J. Brookes, PhD 
 
Professor of Genetics 
 
University of Leicester 
 
Leicester, United Kingdom 
o. 
László G. Boros, MD 
 
Scientific Advisor 
 
SIDMAP, LLC and the Deutenomics Science Institute 
p. 
Angela Spelsberg, MD, SM 
 
Comprehensive Cancer Center Aachen 
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Aachen, Germany 
q. 
Christine Stabell Benn, MD, PhD, DMSc 
 
Professor of Global Health 
 
University of Southern Denmark 
 
Copenhagen, Denmark 
r. 
Peter Aaby, MSc, DMSc 
 
Head of Bandim Health Project, Guinea-Bissau 
 
University of Southern Denmark 
 
Copenhagen, Denmark 
s. 
Ulrich Keil, MD, PhD, FRCP (London) 
 
Professor Emeritus 
 
University of Muenster 
 
Muenster, Germany 
t. 
Barbara Mintzes, BA, MSc, PhD 
 
Associate Professor, School of Pharmacy 
 
The University of Sydney 
 
Sydney, Australia 
u. 
David Healy, MD FRCPsych 
 
Professor of Psychiatry 
 
McMaster University 
 
Ontario, Canada 
v. 
Tom Jefferson, MD MRCGP FFPHM 
 
Senior Associate Tutor 
 
University of Oxford 
w. 
Byram W. Bridle, PhD 
 
Associate Professor of Viral Immunology 
 
Department of Pathobiology 
 
University of Guelph, Ontario 
x. 
Peter C. Gøtzsche, Professor, DrMedSci, MD, MSc 
 
Director 
 
Institute for Scientific Freedom 
 
Copenhagen, Denmark 
y. 
Janice E. Graham, PhD, FRSC, FCAHS 
 
Division of Infectious Diseases 
 
University research Professor 
 
Dalhousie University 
z. 
Justin Lee 
 
Associate Editor 
 
Arc Digital 
aa. 
Serena Tinari 
 
Co-President, Re-Check, Investigating and Mapping Health Affairs 
bb. 
Catherine Riva 
 
Co-President, Re-Check, Investigating and Mapping Health Affairs 
cc. 
Dr. Ira Bernstein, MD 
 
Dept. Family and Community Medicine 
 
University of Toronto 
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dd. 
Dr. Ondrej Halgas, PhD 
 
Biomedical Researcher 
 
University of Toronto 
ee. 
Prof. David Menkes 
 
Associate Professor 
 
University of Auckland 
ff. 
Dr. Peter Abdelmalak 
 
 
Adjunct Professor 
 
 
McMaster University 
 
12. 
The FDA is an agency within the Executive Branch of the United States 
Government, organized within the Department of Health and Human Services.  The FDA is an 
agency within the meaning of 5 U.S.C. § 552(f). 
JURISDICTION AND VENUE 
13. 
This Court has jurisdiction over this action pursuant to 5 U.S.C. § 552(a)(4)(B) and 
28 U.S.C. § 1331. Venue is proper within this District pursuant to 5 U.S.C. § 552(a)(4)(B) and 28 
U.S.C. § 1391.  
FACTS 
A. 
FDA Approval of the Pfizer Vaccine 
14. 
On August 23, 2021, the FDA approved the Pfizer Vaccine for individuals 16 years 
of age and older.7    
15. 
There is an ongoing, public national debate regarding the adequacy of the data and 
information, and analyses of same, relied upon by the FDA to license the Pfizer Vaccine.   
16. 
On the one hand, there are numerous public health officials, media outlets, 
journalists, scientists, politicians, public figures, and others with large social or media platforms 
that have declared that the data and information underlying the licensure of the Pfizer Vaccine is 
more than sufficient for licensure.    
 
7 https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine (last visited 9/5/2021). 
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17. 
For example, in a press release issued on August 23, 2021, acting FDA 
Commissioner Janet Woodcock stated that “the public can be very confident that [the Pfizer 
Vaccine] meets the high standards for safety, effectiveness, and manufacturing quality the FDA 
requires of an approved product.”8   
18. 
Peter Marks, the director of FDA’s Center for Biologics Evaluation and Research, 
made similar remarks, stating that 
[The FDA’s] scientific and medical experts conducted an incredibly 
thorough and thoughtful evaluation of [the Pfizer Vaccine].  We 
evaluated scientific data and information included in hundreds of 
thousands of pages, conducted our own analyses of [the Pfizer 
Vaccine’s] safety and effectiveness, and performed a detailed 
assessment of the manufacturing processes, including inspections of 
the manufacturing facilities[.]9 
19. 
Peter Marks further stated that “although [the FDA] approved [the Pfizer Vaccine] 
expeditiously, it was fully in keeping with [the FDA’s] existing high standards for vaccines in the 
U.S.”10  
20. 
President Biden also stated that the FDA’s approval meets the “gold standard.”11 
21. 
Even prior to FDA approval of the Pfizer Vaccine, government officials, public 
health authorities, and medical professionals repeatedly claimed that COVID-19 vaccines are “safe 
and effective.”12 
 
8 https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine (last visited 9/8/2021). 
9 Id. 
10 Id. 
11 
https://www.cbsnews.com/news/biden-address-covid-19-vaccine-pfizer-fda-approval-watch-live-stream-today-
2021-08-23/ (last visited 9/8/2021). 
12 See, e.g., https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html#:~:text=COVID%
2D19%20vaccines%20are%20safe,vaccine%20as%20soon%20as%20possible. (last visited 9/8/2021). See also 
https://www.hhs.gov/ 
(“COVID-19 
vaccines 
are 
safe, 
effective, 
and 
free) 
(last 
visited 
9/8/2021); 
https://www.who.int/news-room/feature-stories/detail/vaccine-efficacy-effectiveness-and-protection 
(“COVID-19 
vaccines have proven to be safe, effective and life-saving.”) (last visited 9/8/2021); https://www.
doh.wa.gov/Emergencies/COVID19/VaccineInformation/SafetyandEffectiveness (“COVID-19 vaccines are safe”) 
(last visited 9/8/2021); https://www.wlns.com/news/gov-whitmer-and-dr-khaldun-respond-to-the-fda-approval-of-
pfizers-covid-19-vaccine/ (quoting Governor Whitmer referring to the Pfizer Vaccine as a “safe, effective COVID-19 
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22. 
On the other hand, numerous public health officials, media outlets, journalists, 
scientists, politicians, public figures, and others with large social or media platforms have publicly 
raised questions regarding the sufficiency of the data and information, adequacy of the review, and 
appropriateness of the analyses relied upon to license the Pfizer Vaccine, including a number of 
the scientists and journalists that are members of PHMPT.   
23. 
For example, on June 1, 2021, a group of 27 clinicians and scientists, including 
professors from Harvard Medical School and the UCLA School of Public Health, and members of 
PHMPT, filed a Citizen Petition13 with the FDA, claiming that the available evidence for licensure 
of the Pfizer Vaccine “is simply not mature enough at this point to adequately judge whether 
clinical benefits outweigh the risks in all populations.”14   
24. 
Separately, Professor Peter Doshi, a PHMPT member, has publicly questioned the 
lack of transparency regarding the vaccine approval process,15 which Peter Marks publicly 
disputed.16  For example, Peter Doshi publicly claimed that the FDA’s EUA review of the Pfizer 
Vaccine “seem[ed] wholly inadequate” because it “assigned only a single reviewer in each of two 
key scientific disciplines (clinical and statistics) to do the work in three weeks that usually takes 
months to do.”17  In response, Peter Marks asserted that the reviewers Doshi referred to “are simply 
the leads for each review discipline” but failed to identify a single additional individual involved 
 
vaccine”) (last visited 9/8/2021). 
13 https://www.regulations.gov/document/FDA-2021-P-0521-0001 (last visited 9/8/2021). 
14 See https://blogs.bmj.com/bmj/2021/06/08/why-we-petitioned-the-fda-to-refrain-from-fully-approving-any-covid-
19-vaccine-this-year/ (last visited 9/8/2021). 
15 See https://blogs.bmj.com/bmj/2021/08/23/does-the-fda-think-these-data-justify-the-first-full-approval-of-a-covid-
19-vaccine/ (last visited 9/8/2021); https://blogs.bmj.com/bmj/2021/01/04/peter-doshi-pfizer-and-modernas-95-
effective-vaccines-we-need-more-details-and-the-raw-data/ (last visited 9/8/2021); https://blogs.bmj.com/bmj/2020/
11/26/peter-doshi-pfizer-and-modernas-95-effective-vaccines-lets-be-cautious-and-first-see-the-full-data/ 
(last 
visited 9/8/2021). 
16 
https://www.statnews.com/2020/12/17/did-the-fda-understaff-its-review-of-the-pfizer-biontech-vaccine/ 
(last 
visited 9/8/2021). 
17 Id. 
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in the review.18 
25. 
Peter Doshi has also questioned the adequacy of the data on the basis that the Pfizer 
Vaccine is only “13 months into the still ongoing, two year pivotal trial, with no reported data past 
13 March 2020, unclear efficacy after six months due to unblinding, evidence of waning protection 
irrespective of the Delta variant, and limited reporting of safety data.”19  
26. 
Andrew Kheriaty, professor of psychiatry at UCI School of Medicine, Director of 
the Medical Ethics Program at UCI Health,20 and also a member of PHMPT, has also questioned 
the FDA’s approval process.  For example, in an article published in the Wall Street Journal, Dr. 
Kheriaty questioned the need for student vaccination requirements based on, among other things, 
a review21 by the FDA’s Vaccines and Related Biological Products Advisory Committee 
(“VRBPAC”) that indicates a risk of heart inflammation after vaccination.22  
27. 
Government officials have raised similar concerns about the lack of transparency 
in the review process, arguing that it is “essential” for the FDA to, among other things, “make the 
data generated by clinical trials and supporting documents submitted to the FDA by developers 
available to the public[.]”23  Despite all eyes on the COVID-19 vaccines and calls for transparency 
regarding the FDA’s actions, the FDA did not convene its advisory group, VRBPAC, to have a 
public meeting prior to licensure.  Those interested were denied the opportunity to both hear 
discussion about the data and to offer public comment about same. 
 
18 Id. 
19 https://blogs.bmj.com/bmj/2021/08/23/does-the-fda-think-these-data-justify-the-first-full-approval-of-a-covid-19-
vaccine/ (last visited 9/8/2021). 
20 https://www.aaronkheriaty.com/bio (last visited 9/8/2021). 
21 https://www.fda.gov/media/150054/download (last visited 9/8/2021). 
22 
https://www.wsj.com/articles/university-vaccine-mandates-violate-medical-ethics-11623689220 
(last 
visited 
9/8/2021). 
23https://www.warren.senate.gov/imo/media/doc/2020.09.14%20Letter%20to%20FDA%20re%20transparency%20i
n%20vaccine%20review%20process_.pdf (last visited 9/8/2021). See also https://www.washingtontimes.com/
news/2021/aug/23/editorial-the-coincidental-timing-of-pfizers-vacci/ (last visited 9/8/2021). 
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B. 
Vaccine Requirements 
28. 
Over the objections of many, the Pfizer Vaccine is being mandated to individuals 
across the country by the federal government,24 local governments,25 public and private 
employers,26 universities, 27 schools,28 and various other institutions,29 and many more entities are 
expected to follow suit.30   
29. 
At the federal level, legislation was recently introduced that would require COVID-
 
24 See, e.g., https://www.natlawreview.com/article/covid-19-vaccine-added-to-requirements-green-card-processing-
effective-oct-1 
(last 
visited 
9/8/2021); 
https://apnews.com/article/business-health-coronavirus-pandemic-
coronavirus-vaccine-4cf7451267919302de4a7b591508e80c 
(last 
visited 
9/8/2021); 
https://www.forbes.com/
sites/joewalsh/2021/08/09/us-military-will-require-covid-vaccinations-by-mid-september/?sh=78defacd6c9f 
(last 
visited 9/8/2021); https://www.whitehouse.gov/briefing-room/statements-releases/2021/07/29/fact-sheet-president-
biden-to-announce-new-actions-to-get-more-americans-vaccinated-and-slow-the-spread-of-the-delta-variant/ 
(last 
visited 9/8/2021).  
25 See, e.g., https://www.cnn.com/2021/08/12/us/san-francisco-vaccine-requirement/index.html (last visited 
9/8/2021); https://www1.nyc.gov/site/doh/covid/covid-19-vaccines-keytonyc.page (last visited 9/8/2021); https://
news.yahoo.com/orleans-now-requires-proof-vaccination-230433492.html (last visited 9/8/2021). 
26 See, e.g., https://www.cnbc.com/2021/08/06/united-airlines-vaccine-mandate-employees.html (last visited 
9/8/2021); 
https://sanfrancisco.cbslocal.com/2021/08/02/covid-kaiser-permanente-makes-vaccination-mandatory-
for-all-employees/ (last visited 9/8/2021); https://abcnews.go.com/Health/wireStory/walmart-mandates-vaccines-
workers-headquarters-79177220 (last visited 9/8/2021); https://www.kpbs.org/news/2021/aug/17/encinitas-covid-19-
vaccine-negative-test-employees/ 
(last 
visited 
9/8/2021); 
https://www.cnbc.com/2021/08/09/covid-vaccine-
mandates-sweep-across-corporate-america-as-delta-surges.html (last visited 9/8/2021); https://www.reuters.com
/business/energy/chevron-begins-covid-19-vaccination-mandates-wsj-2021-08-23/ (last visited 9/8/2021); https://
thehill.com/policy/healthcare/569051-pfizers-full-approval-triggers-new-vaccine-mandates (last visited 9/8/2021); 
https://cvshealth.com/news-and-insights/statements/cvs-health-will-require-covid-19-vaccinations-for-clinical-and-
corporate-employees (last visited 9/8/2021). 
27 See https://universitybusiness.com/state-by-state-look-at-colleges-requiring-vaccines/ (last visited 9/8/2021). See 
also, e.g., https://www.nbcnews.com/health/health-news/colleges-universities-covid-vaccination-mandates-facing-
pushback-n1273916 (last visited 9/8/2021); https://www.colorado.edu/covid-19-updates/covid-19-vaccination (last 
visited 9/8/2021); https://uhs.berkeley.edu/requirements/covid19 (last visited 9/8/2021); https://huhs.harvard
.edu/covid-19-vaccine-requirement-faqs 
(last 
visited 
9/8/2021); 
https://www2.gmu.edu/safe-return-campus
/vaccination-requirements (last visited 9/8/2021); https://www.pc.pitt.edu/news/vaccine-disclosure-requirements-
2021-2022-campus-housing (last visited 9/8/2021) 
28 See, e.g., https://www.npr.org/sections/back-to-school-live-updates/2021/08/20/1029837338/a-california-school-
district-mandates-vaccines-for-eligible-students (last visited 9/8/2021); https://patch.com/massachusetts/salem
/salem-school-committee-approves-vaccine-mandate-sports-band (last visited 9/8/2021); https://www.nbcnewyork
.com/news/coronavirus/nyc-will-require-vaccination-for-high-risk-school-sports/3232745/ (last visited 9/8/2021); 
https://www.nj.com/hudson/2021/08/hoboken-believed-to-be-first-in-state-to-issue-mandate-for-students-12-and-up-
get-vaccine-or-face-weekly-testing.html (last visited 9/8/2021); https://www.mercurynews.com/2021/08/19/la-
county-school-district-mandates-covid-vaccines-for-k12-kids-others-soon-may-follow/ (last visited 9/8/2021). 
29 See, e.g., https://www.reuters.com/world/us/new-york-city-mandates-covid-19-vaccine-public-school-teachers-
staff-mayor-2021-08-23/ (last visited 9/8/2021); https://www.cbsnews.com/news/california-covid-vaccine-teachers-
mandate/ 
(last 
visited 
9/8/2021); 
https://www.nytimes.com/2021/08/18/us/washington-state-teacher-vaccine-
mandate.html (last visited 9/8/2021); https://www.governor.ny.gov/news/governor-cuomo-announces-covid-19-
vaccination-mandate-healthcare-workers (last visited 9/8/2021); https://www.cdph.ca.gov/Programs/CID/DCDC
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19 vaccines for air travel into or out of the United States31 and the Pentagon has mandated COVID-
19 vaccines for all military personnel.32  In addition, Present Biden recently announced vaccine 
mandates for all employers with 100 or more employees, all federal employees, and all employees 
of federal contractors.33 
30. 
At the state level, legislation has been introduced to require COVID-19 vaccines 
for all post-secondary students,34 all state employees, 35 and even for all citizens of the state.36   
31. 
As explained by Dr. Anthony Fauci, “a flood” of vaccine mandates will follow 
FDA approval of a COVID-19 vaccine37 and President Biden is actively encouraging “companies 
in the private sector to step up the vaccine requirements[.]”38   
 
/Pages/COVID-19/FAQ-Health-Care-Worker-Vaccine-Requirement.aspx (last visited 9/8/2021); https://www.
nytimes.com/2021/08/09/us/washington-state-workers-vaccine-mandate.html (last visited 9/8/2021); https://www.
denvergov.org/Government/COVID-19-Information/Public-Health-Orders-Response/News-Updates/2021/Mayor-
Hancock-Announces-COVID-19-Vaccine-Requirement-for-Employees (last visited 9/8/2021); See https://www.
bostonherald.com/2021/08/19/baker-issues-vaccine-mandate-for-42000-state-employees/ (last visited 9/8/2021).  
30 See https://www.mississippifreepress.org/15126/fda-fully-approves-pfizer-biontech-vaccine-mandates-to-follow/ 
(last visited 9/8/2021); https://www.huffpost.com/entry/vaccine-mandates-roll-out-fda-approval_n_6123e028e4b0
df3eacd5d657 (last visited 9/8/2021); https://www.theadvocate.com/baton_rouge/news/coronavirus/article_9be6
d02c-0434-11ec-b7b1-cb17d8495274.html?utm_medium=social&utm_source=twitternoladotcom&utm_campaign=
snd (last visited 9/8/2021). See also https://www.latimes.com/california/story/2021-08-26/california-lawmakers-
grapple-with-statewide-covid-19-vaccine-mandate (last visited 9/8/2021). 
31 https://www.congress.gov/bill/117th-congress/house-bill/4980?q=%7B%22search%22:%5b%224980%252 (last 
visited 8/23/2021). 
32 
https://thehill.com/policy/defense/568996-pentagon-to-mandate-covid-19-vaccine-for-military 
(last 
visited 
8/23/2021). 
33 https://www.whitehouse.gov/covidplan/ (last visited 9/13/2021). See also https://www.cnn.com/2021/09/09/
politics/joe-biden-covid-speech/index.html (last visited 9/13/2021). 
34  See New York bill S6495 available at https://www.nysenate.gov/legislation/bills/2021/S6495 (last visited 
9/8/2021). 
35 
See, 
e.g., 
https://www.nj.com/coronavirus/2021/08/murphy-orders-vaccination-requirement-for-all-nj-state-
workers-including-at-public-colleges.html (last visited 9/8/2021). 
36 See New York bill A11179 available at https://www.nysenate.gov/legislation/bills/2019/A11179. See generally 
https://eastcountytoday.net/buffy-wicks-transportation-bill-could-become-california-vaccine-passport-bill/ 
(last 
visited 9/8/2021). 
37 https://www.usatoday.com/story/news/health/2021/08/06/anthony-fauci-covid-vaccine-mandates-fda-full-approval
/5513121001/ (last visited 9/8/2021). 
38 
https://www.msn.com/en-us/news/us/biden-urges-private-companies-to-implement-covid-19-vaccine-require
ments-following-pfizer-e2-80-99s-fda-approval/ar-AANEcYs?ocid=uxbndlbing (last visited 9/8/2021). See also 
https://www.nytimes.com/2021/08/23/us/pfizer-vaccine-mandates.html (noting that FDA approval of the Pfizer 
Vaccine “is opening the way for institutions like the military, corporate employers, hospitals and school districts to 
announce vaccine mandates for their employees”) (last visited 8/23/2021); https://www.msn.com/en-us/news/us/now-
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32. 
More recently, it appears that mandates may now encompass additional booster 
shots of the vaccine in order to retain a “fully vaccinated” status.39 
C. 
The FOIA Request 
33. 
In furtherance of PHMPT’s mission to disseminate information to the public, and 
in an effort to ensure that the FDA acts consistently with its commitment to transparency,40 on 
August 27, 2021, PHMPT submitted the FOIA Request to the FDA. Pursuant to the FOIA Request, 
PHMPT requested that the following documents be produced on an expedited basis: 
All data and information for the Pfizer Vaccine enumerated in 
21 C.F.R. § 601.51(e)41 with the exception of publicly available 
reports on the Vaccine Adverse Events Reporting System.42 
 
(Exhibit A.1.)43 
 
34. 
Upon submitting the FOIA Request, PHMPT immediately received confirmation 
that the FOIA Request was submitted successfully.  (Exhibit A.2.) 
 
that-a-covid-19-shot-is-fully-approved-employer-mandates-are-rolling-in-but-will-vaccination-rates-in-the-us-go-up
/ar-AANGDTy?ocid=uxbndlbing  (last visited 8/23/2021); https://news.yahoo.com/surgeon-general-vivek-murthy-
says-205530053.html (quoting the Surgeon General referring to vaccine mandates as “reasonable”) (last visited 
8/23/2021). 
39 See https://www.nbcnews.com/health/health-news/u-s-announces-plan-offer-boosters-all-americans-starting-late-
n1277059 (quoting the U.S. Surgeon General stating “it is our clinical judgment that the time to lay out a plan for 
Covid-19 boosters is now”) (last visited 9/13/2021); https://www.youtube.com/watch?v=ciVGAPuruoQ at 17:21 
(video of Rochelle P. Walensky, Director of the CDC, stating “we are planning for Americans to receive booster 
shots”) (last visited 9/13/2021).  
40 
https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine 
(last 
visited 
9/5/2021). 
41 21 C.F.R. § 601.51(e) provides that after a biological product is licensed, the following information shall be made 
available for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data and 
information. (2) A protocol for a test or study . . . .  (3) Adverse reaction reports, product experience reports, consumer 
complaints, and other similar data and information . . . . (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].” 
42 For the avoidance of doubt, this 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. 
43 All “Exhibits” referenced herein are attached to this Complaint. 
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35. 
On August 31, 2021, the FDA issued an acknowledgment and assigned case 
number 2021-5683 to the FOIA Request. (Exhibit A.3.) 
D. 
Request for Expedited Processing  
36. 
In the FOIA Request, PHMPT requested that the FDA process the FOIA Request 
on an expedited basis pursuant to 5 U.S.C. § 552(a)(6)(E)(v)(II). 
37. 
On September 9, 2021, the FDA denied PHMPT’s request for expedited processing 
of the FOIA Request (the “Denial Letter”).44  In the Denial Letter, the FDA stated in relevant 
part: 
I have determined that your request for expedited processing does 
not meet the criteria under the FOIA. You have not demonstrated a 
compelling need that involves an imminent threat to the life or 
physical safety of an individual. Neither have you demonstrated that 
there exists an urgency to inform the public concerning actual or 
alleged Federal Government activity. Therefore, I am denying your 
request for expedited processing. 
   
(Exhibit A.4.) 
ARGUMENT 
38. 
FOIA provides for “expedited processing of request for records” upon a showing 
of “compelling need.” 5 U.S.C. § 552(a)(6)(E)(i)(II).  When the person requesting information is 
“primarily engaged in disseminating information urgency to inform the public concerning actual 
or alleged Federal Government activity” constitutes a “compelling need” for expedited processing. 
5 U.S.C. § 552(a)(6)(E)(v)(II).  
39. 
PHMPT requested expedited processing of the FOIA Request on the basis that it is 
“primarily engaged in disseminating information” and that there is an “urgency to inform the 
public concerning actual or alleged Federal Government activity.”  In the Denial Letter, the FDA 
 
44 The FOIA requires federal agencies to issue determinations on requests for expedited processing within ten days 
from the date of the request. 5 U.S.C. § 552(a)(6)(E)(ii)(I). The FDA’s denial of PHMPT’s request for expedited 
processing was issued 13 days after PHMPT issued the FOIA Request. 
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challenged PHMPT’s request for expedited processing only on the basis that PHMPT allegedly 
failed to “demonstrate[] a compelling need that involves an imminent threat to the life or physical 
safety of an individual” or “that there exists an urgency to inform the public concerning actual or 
alleged Federal Government activity.”  As explained below, the FDA is wrong as there is an urgent 
need for the medical and scientific community and the public to review the data and information 
underlying the FDA’s approval of the Pfizer Vaccine.   
40. 
The FDA does not and cannot challenge that PHMPT is “primarily engaged in 
disseminating information.”  PHMPT is an organization made up of public health professionals, 
medical professionals, scientists, and journalists.  PHMPT exists for the sole purpose of 
disseminating to the public the data and information in the biological product files for each of the 
COVID-19 vaccines.  PHMPT intends to make any records produced in response to the FOIA 
request immediately available to the public through both its website and its individual members’ 
platforms.  Many of PHMPT’s individual members, including all its members that are journalists, 
are primarily engaged in disseminating information to the public and do so across various 
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platforms, including through interviews,45 articles,46 blogs,47 essays,48 and podcasts.49  Therefore, 
PHMPT and many of its members are “primarily engaged in disseminating information to the 
general public,” and, as explained below, there is a clear “urgency to inform the public concerning 
actual or alleged Federal Government activity,” here, the data and information underlying the 
licensure by the FDA of the Pfizer Vaccine.   
41. 
In determining whether there is “urgency to inform the public,” courts consider: 
“(1) whether the request concerns a matter of current exigency to the American public; (2) whether 
the consequences of delaying a response would compromise a significant recognized interest; and 
(3) whether the request concerns federal government activity.” Al-Fayed v. CIA, 254 F.3d 300, 310 
(D.D.C. 2001). All three factors are present here. 
42. 
The FOIA Request concerns a matter of current exigency to the American public. 
 
45 
See, 
e.g., 
https://www.foxnews.com/transcript/ingraham-angle-on-mask-mandates-bidens-failure-in-his-role 
(Harvey Risch) (last visited 8/26/2021) 
46 See, e.g., https://www.bmj.com/content/373/bmj.n1244 (Peter Doshi) (last visited 9/8/2021); https://www.bmj.com
/content/371/bmj.m4058 (Peter Doshi) (last visited 9/8/2021); https://www.bmj.com/content/371/bmj.m4037 (Peter 
Doshi) (last visited 9/8/2021); https://www.wsj.com/articles/are-covid-vaccines-riskier-than-advertised-11624381749 
(last 
visited 
8/25/2021); 
https://www.wsj.com/articles/university-vaccine-mandates-violate-medical-ethics-
11623689220 
(Aaron 
Kheriaty 
and 
Gerard 
V. 
Bradley) 
(last 
visited 
9/8/2021); 
https://thefederalist.com/2021/07/05/how-college-covid-vaccine-mandates-put-students-in-danger/ (Andrew Bostom, 
Aaron Kheriaty, Peter A. McCullough, Harvey A. Rish, Michelle Cretella, and Gerard V. Bradley) (last visited 
9/8/2021); 
https://thefederalist.com/2021/08/18/why-forcing-unvaccinated-students-to-wear-cloth-masks-is-anti-
science/ (Andrew Bostom, Gerard Bradley, Aaron Kheriaty, and Harvey Risch) (last visited 9/8/2021); 
https://www.bmj.com/content/bmj/374/bmj.n1737.full.pdf (Serena Tinari and Catherine Riva) (last visited 9/8/2021); 
https://www.bmj.com/content/372/bmj.n627 
(Serena 
Tinari) 
(last 
visited 
9/8/2021); 
https://ebm.bmj.com/content/early/2021/08/08/bmjebm-2021-111735 (Sarah Tanveer, Anisa Rowhani-Farid, 
Kyungwan Hong, Tom Jefferson, Peter Doshi) (last visited 9/8/2021); https://www.arcdigital.media/p/medical-
ethicist-sues-the-university (Justin Lee) (last visited 9/8/2021). 
47 See, e.g., https://blogs.bmj.com/bmj/2021/08/23/does-the-fda-think-these-data-justify-the-first-full-approval-of-a-
covid-19-vaccine/ (Peter Doshi) (last visited 9/8/2021); https://blogs.bmj.com/bmj/2020/11/26/peter-doshi-pfizer-
and-modernas-95-effective-vaccines-lets-be-cautious-and-first-see-the-full-data/ (Peter Doshi) (last visited 9/8/2021). 
See also https://www.re-check.ch/wordpress/en/covid-certificate/ (Catherine Riva and Serena Tinari) (last visited 
9/8/2021). 
48 
See 
https://www.andrewbostom.org/2021/06/why-collegiate-covid-19-vaccine-mandates-are-lysenkoist-anti-
science/ (Andrew Bostom) (last visited 9/8/2021). 
49 See, e.g., https://www.andrewbostom.org/2021/05/dr-andrew-bostom-discusses-the-unfavorable-risk-benefit-ratio-
of-covid-19-vaccination-of-very-low-covid-19-risk-12-to-17-year-olds-with-pfizers-emergency-use-authorization-
only-mrna-vaccine/ (Andrew Bostom) (last visited 9/8/2021). 
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The FDA itself acknowledges this exigency in the Code of Federal Regulations, which expressly 
provides that “[a]fter 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. . . .” 21 C.F.R. § 601.51(e) (emphasis 
added).  The FDA’s own regulations thus expressly recognize the importance of having the data 
and information relied upon to license a vaccine “immediately available for public disclosure.”  Id.  
The FDA’s regulation not only supports the need for expedited treatment under FOIA but is also 
an independent legal basis that requires expedited treatment of the FOIA Request. 
43. 
This policy is not surprising given the FDA’s commitment to transparency and its 
entire program to assure transparency, because a lack of transparency erodes the confidence the 
medical and scientific community and the public have in the conclusions reached by the FDA.50   
44. 
Beyond the FDA’s own regulations which admit the urgent need for transparency 
and immediate disclosure in this situation, there are two additional reasons that warrant expedited 
treatment of this request.  
45. 
First, as explained above, there is an ongoing, public national debate regarding the 
adequacy of the data and information, and analyses of same, relied upon by the FDA to license the 
Pfizer Vaccine.   
46. 
Although public health officials, media outlets, journalists, scientists, politicians, 
public figures, and others with large social or media platforms that have declared that the data and 
 
50 https://www.fda.gov/about-fda/transparency (last visited 9/8/2021).  As required by Congress, the FDA may only 
license vaccines that have been proven to be “safe and effective,” see, e.g., 21 U.S.C. § 393, and the FDA makes this 
determination based on, inter alia, clinical trial reports provided by the sponsor which must be sufficient to 
demonstrate the product is both “safe” and “effective.”  21 C.F.R. 601.2(a).  The FDA explains in its guidance 
materials 
that 
the 
clinical 
trials 
relied 
upon 
for 
approval 
are 
typically 
“1 
to 
4 
years” 
(https://www.fda.gov/patients/drug-development-process/step-3-clinical-research) and the duration of clinical trials 
should “reflect the product and target condition.” https://www.fda.gov/media/102332/download (last visited 
9/8/2021). See also https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved (last visited 9/8/2021); 
https://www.fda.gov/about-fda/what-we-do (last visited 9/8/2021). 
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information underlying the licensure of the Pfizer Vaccine is more than sufficient for licensure,51 
numerous public health officials, media outlets, journalists, scientists, politicians, public figures, 
and others with large social or media platforms have publicly raised questions regarding the 
sufficiency of the data and information, the adequacy of the review, and appropriateness of the 
analyses relied upon to license the Pfizer Vaccine, including a number of the scientists and 
journalists that are members of PHMPT.52   
47. 
The public debate is unlikely to be settled without full disclosure of the data and 
information underlying the FDA’s conclusion that the Pfizer Vaccine is “safe and effective.” 
48. 
Given the widespread and ongoing public debate, the medical and scientific 
community and the public has an immediate need to review the data and information underlying 
the licensure of the Pfizer Vaccine.  Public disclosure of this information will inform this ongoing 
public debate.  
49. 
There is also an urgent need for the public to have immediate access to the data and 
information underlying the licensure of the Pfizer Vaccine because, over the objections of many, 
this product is being mandated to individuals across the country by the federal government,53 local 
 
51 See, e.g., supra ¶¶ 16-21. 
52 See, e.g., supra ¶¶ 22-27. 
53 See, e.g., https://www.natlawreview.com/article/covid-19-vaccine-added-to-requirements-green-card-processing-
effective-oct-1 
(last 
visited 
9/8/2021); 
https://apnews.com/article/business-health-coronavirus-pandemic-
coronavirus-vaccine-4cf7451267919302de4a7b591508e80c 
(last 
visited 
9/8/2021); 
https://www.forbes.com/
sites/joewalsh/2021/08/09/us-military-will-require-covid-vaccinations-by-mid-september/?sh=78defacd6c9f 
(last 
visited 9/8/2021); https://www.whitehouse.gov/briefing-room/statements-releases/2021/07/29/fact-sheet-president-
biden-to-announce-new-actions-to-get-more-americans-vaccinated-and-slow-the-spread-of-the-delta-variant/ 
(last 
visited 9/8/2021).  
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governments, 54 public and private employers,55 universities, 56 schools,57 and various other 
institutions,58 and many are expected to follow suit.59   
50. 
During a time when COVID-19 vaccine mandates are being implemented60 over 
 
54 See, e.g., https://www.cnn.com/2021/08/12/us/san-francisco-vaccine-requirement/index.html (last visited 
9/8/2021); https://www1.nyc.gov/site/doh/covid/covid-19-vaccines-keytonyc.page (last visited 9/8/2021); https://
news.yahoo.com/orleans-now-requires-proof-vaccination-230433492.html (last visited 9/8/2021). 
55 See, e.g., https://www.cnbc.com/2021/08/06/united-airlines-vaccine-mandate-employees.html (last visited 
9/8/2021); 
https://sanfrancisco.cbslocal.com/2021/08/02/covid-kaiser-permanente-makes-vaccination-mandatory-
for-all-employees/ (last visited 9/8/2021); https://abcnews.go.com/Health/wireStory/walmart-mandates-vaccines-
workers-headquarters-79177220 (last visited 9/8/2021); https://www.kpbs.org/news/2021/aug/17/encinitas-covid-19-
vaccine-negative-test-employees/ 
(last 
visited 
9/8/2021); 
https://www.cnbc.com/2021/08/09/covid-vaccine-
mandates-sweep-across-corporate-america-as-delta-surges.html (last visited 9/8/2021); https://www.reuters.com
/business/energy/chevron-begins-covid-19-vaccination-mandates-wsj-2021-08-23/ (last visited 9/8/2021); https://
thehill.com/policy/healthcare/569051-pfizers-full-approval-triggers-new-vaccine-mandates (last visited 9/8/2021); 
https://cvshealth.com/news-and-insights/statements/cvs-health-will-require-covid-19-vaccinations-for-clinical-and-
corporate-employees (last visited 9/8/2021). 
56 See https://universitybusiness.com/state-by-state-look-at-colleges-requiring-vaccines/ (last visited 9/8/2021). See 
also, e.g., https://www.nbcnews.com/health/health-news/colleges-universities-covid-vaccination-mandates-facing-
pushback-n1273916 (last visited 9/8/2021); https://www.colorado.edu/covid-19-updates/covid-19-vaccination (last 
visited 9/8/2021); https://uhs.berkeley.edu/requirements/covid19 (last visited 9/8/2021); https://huhs.harvard
.edu/covid-19-vaccine-requirement-faqs 
(last 
visited 
9/8/2021); 
https://www2.gmu.edu/safe-return-campus
/vaccination-requirements (last visited 9/8/2021); https://www.pc.pitt.edu/news/vaccine-disclosure-requirements-
2021-2022-campus-housing (last visited 9/8/2021) 
57 See, e.g., https://www.npr.org/sections/back-to-school-live-updates/2021/08/20/1029837338/a-california-school-
district-mandates-vaccines-for-eligible-students (last visited 9/8/2021); https://patch.com/massachusetts/salem
/salem-school-committee-approves-vaccine-mandate-sports-band (last visited 9/8/2021); https://www.nbcnewyork
.com/news/coronavirus/nyc-will-require-vaccination-for-high-risk-school-sports/3232745/ (last visited 9/8/2021); 
https://www.nj.com/hudson/2021/08/hoboken-believed-to-be-first-in-state-to-issue-mandate-for-students-12-and-up-
get-vaccine-or-face-weekly-testing.html (last visited 9/8/2021); https://www.mercurynews.com/2021/08/19/la-
county-school-district-mandates-covid-vaccines-for-k12-kids-others-soon-may-follow/ (last visited 9/8/2021). 
58 See, e.g., https://www.reuters.com/world/us/new-york-city-mandates-covid-19-vaccine-public-school-teachers-
staff-mayor-2021-08-23/ (last visited 9/8/2021); https://www.cbsnews.com/news/california-covid-vaccine-teachers-
mandate/ 
(last 
visited 
9/8/2021); 
https://www.nytimes.com/2021/08/18/us/washington-state-teacher-vaccine-
mandate.html (last visited 9/8/2021); https://www.governor.ny.gov/news/governor-cuomo-announces-covid-19-
vaccination-mandate-healthcare-workers (last visited 9/8/2021); https://www.cdph.ca.gov/Programs/CID/DCDC
/Pages/COVID-19/FAQ-Health-Care-Worker-Vaccine-Requirement.aspx (last visited 9/8/2021); https://www.
nytimes.com/2021/08/09/us/washington-state-workers-vaccine-mandate.html (last visited 9/8/2021); https://www.
denvergov.org/Government/COVID-19-Information/Public-Health-Orders-Response/News-Updates/2021/Mayor-
Hancock-Announces-COVID-19-Vaccine-Requirement-for-Employees (last visited 9/8/2021); See https://www.
bostonherald.com/2021/08/19/baker-issues-vaccine-mandate-for-42000-state-employees/ (last visited 9/8/2021).  
59 See https://www.mississippifreepress.org/15126/fda-fully-approves-pfizer-biontech-vaccine-mandates-to-follow/ 
(last visited 9/8/2021); https://www.huffpost.com/entry/vaccine-mandates-roll-out-fda-approval_n_6123e028e4b0
df3eacd5d657 (last visited 9/8/2021); https://www.theadvocate.com/baton_rouge/news/coronavirus/article_9be6
d02c-0434-11ec-b7b1-cb17d8495274.html?utm_medium=social&utm_source=twitternoladotcom&utm_campaign=
snd (last visited 9/8/2021). See also https://www.latimes.com/california/story/2021-08-26/california-lawmakers-
grapple-with-statewide-covid-19-vaccine-mandate (last visited 9/8/2021). 
60 See, e.g., supra ¶¶ 28-32. 
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the objection of those that have questions about the data and information supporting the safety and 
efficacy of the Pfizer Vaccine, and individuals with these questions are being expelled from 
employment, school, transportation, restaurants, entertainment facilities, and the military, the 
public has an urgent and immediate need to have access to this data.  The urgent need for the public 
to review this data is heightened by President Biden’s recent announcement of vaccine mandates 
for millions of Americans, including employers with 100 or more employees, federal employees, 
and employees of federal contractors.61    
51. 
PHMPT will forthwith disseminate any information it obtains in response to the 
FOIA Request.  PHMPT, as an entity primarily engaged in disseminating information, has a 
recognized interest in timely contributing to the ongoing public debate regarding the adequacy of 
the data and information underlying the FDA’s approval of the Pfizer Vaccine.  
52. 
Finally, the information PHMPT seeks concerns actual or alleged federal 
government activity – namely, whether the FDA properly approved the Pfizer Vaccine based on 
adequate data and information.  The FDA, which is committed to transparency, should 
immediately release the information PHMPT seeks in the FOIA Request.  
53. 
Because the FDA denied PHMPT’s request for expedited processing, PHMPT is 
entitled to immediately seek relief in this Court. 5 U.S.C. § 552(a)(6)(E)(iii). 
Requested Relief 
WHEREFORE, Plaintiff prays that this Court: 
a. 
Provide for expeditious proceedings in this action; 
b. 
Enter an Order directing the FDA to produce all documents responsive to the FOIA 
Request on an expedited basis and in no event later than 10 days from the date of 
 
61 https://www.whitehouse.gov/covidplan/ (last visited 9/13/2021). See also https://www.cnn.com/2021/09/09/
politics/joe-biden-covid-speech/index.html (last visited 9/13/2021). 
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any such order;  
c. 
Award Plaintiff its costs and reasonable attorneys’ fees incurred in this action as 
provided by 5 U.S.C. § 552(a)(4)(E); and 
d. 
Grant such other and further relief as the Court may deem just and proper.  
 
 
Dated:  September 16, 2021 
 
 
 
SIRI & GLIMSTAD LLP 
Aaron Siri (pro hac vice to be filed) 
Elizabeth Brehm (pro hac vice to be filed) 
Gabrielle Palmer (pro hac vice to be filed) 
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 
 
 
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 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
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