20210907 UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TENNESSEE
Children’s Health Defense Sues FDA Over Approval of Pfizer Comirnaty Vaccine
UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TENNESSEE
https://childrenshealthdefense.org/wp-content/uploads/CHD-v.-FDA-Submitted-Complaint-8.31.21.pdf
1
UNITED
STATES DISTRICT COURT
FOR
THE EASTERN DISTRICT OF TENNESSEE
CHILDREN’S
HEALTH DEFENSE, and AMY MILLER, an individual, Plaintiffs, v. FOOD & DRUG
ADMINISTRATION, and JANET WOODCOCK, acting commissioner of Food & Drugs,
Defendants Case No. ________________________ COMPLAINT
1. The FDA faced a conundrum: under immense political
pressure to rush approval
of a
COVID-19 vaccine in record time to satiate the mandate fervor of some in the
military and
corporate
America, the FDA acted -- without consulting its advisory board, without
answering
citizen
petitions, without addressing scientific concerns, and even without updating
its data
regarding
the Delta coronavirus variant. Knowing that approval and licensure of such a
vaccine
required
revoking all Emergency Use Authorized vaccines for the same indication, and
knowing
that
revocation would risk liability exposure to vaccine makers, government actors
and
healthcare
workers, the FDA did the impermissible. 2. It answered this conundrum by pretending to
"approve" a vaccine that isn't widely
available,
playing a game of bait-and-switch, and confusing the public into thinking they
are
getting
a vaccine with some legal remedies when in fact they are not because of the
bait-and-
switch.
The FDA purportedly managed to do what the law forbids: "approve" a
vaccine but not
revoke
any Emergency Use Authorized vaccines for the same indication. 3. Plaintiff Children’s Health Defense (CHD) and Amy
Miller bring this action
Case 1:21-cv-00200 Document 1 Filed 08/31/21
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2 because the FDA is failing to carry out its mission.
Plaintiffs seek this Court’s intervention to put
the FDA back on the path to lawful
protection of the public in these precarious times.
PARTIES
4. Plaintiff CHD is a not-for-profit membership organization
incorporated under the
laws of Georgia. Plaintiff sues in
its own capacity and on behalf of its members who have been
affected by Defendants’ actions. 5. Plaintiff
Amy Miller is resident of Hamilton County Co., TN, a member of CHD
and is at imminent risk of immediate
harm from FDA’s actions to both license and
contemporaneously authorize Pfizer
vaccines against COVID. 6. Defendant FDA is an agency within the U.S. Department of
Health and Human
Services. 7. Defendant
Janet Woodcock, the Acting FDA Commissioner, is sued in her
official capacity.
JURISDICTION AND VENUE
8. This action arises out of Defendants’ acts under 21 U.S.
Code § 360bbb-3,
Authorization for medical products
for use in emergencies, and the Administrative Procedures
Act, 5 U.S.C. § 500 et seq. 9. This
lawsuit raises federal questions over which this Court has jurisdiction
pursuant to 28 U.S.C. §§ 1331, 1361.
This Court also has jurisdiction over this matter as
complete diversity exists among the
parties. 10. Pursuant to 28 U.S.C. § 1391(e), venue is proper in the
Eastern District of
Tennessee, where Plaintiff Amy
Miller resides. Under 5 U.S.C. § 703, venue is proper in any
court of competent jurisdiction.
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PageID #: 2
11. An actual
and justiciable controversy exists between Plaintiffs and Defendants.
STATEMENT
OF FACTS
12. On January 31, 2020, Alex M. Azar, II, the Secretary
of Health and Human
Services,
declared a public health emergency as of January 27, 2020, pursuant to § 319 of
the
Public
Health Service Act, 42 U.S.C. § 247d et seq. 13. Section 564 of the Federal Food, Drug, and Cosmetic
Act (FFDCA), 21 U.S.C. §
360bbb-3,
authorizes the FDA to issue an Emergency Use Authorization (EUA) for a vaccine
under
certain emergency circumstances, allowing a vaccine to be introduced and
administered to
the
public even when the product has not gone through the review process necessary
for approval
and
licensure. 14. In an
emergency, the Secretary of Health and Human Services may issue EUAs if
he
concludes that the following facts exist: (1) a serious or life-threatening
disease; (2) a product
“may
be effective” in treating or preventing it; (3) “no adequate, approved, and
available
alternative
to the product for diagnosing, preventing, or treating such disease or
condition;” (4) a
risk-benefit
analysis that measures both the known and potential benefits of the product
against
the
known and potential risks of the product is positive; and (5) that the
patient’s option to accept
or
decline the product is protected through informed consent. 21 U.S.C. §
360bbb-3(c)(1)-(5). 15. On December 11, 2020, the FDA issued an EUA for use of
Pfizer-BioNTech
COVID‑19
Vaccine to prevent COVID-19 for individuals 16 years of age and older pursuant
to
Section
564 of the Act. 16. The FDA
issued EUAs to Pfizer even though its Phase III clinical trials even now
remain
incomplete. Pfizer's clinical trial Estimated Primary Completion Date is
November 2,
2022,
and the Estimated Study Completion Date is May 2, 2023. See Study to Describe
the
Case 1:21-cv-00200 Document 1 Filed 08/31/21
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4
Safety,
Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against
COVID-
19 in
Healthy Individuals, CLINICALTRIALS.GOV,
https://clinicaltrials.gov/ct2/show/NCT04368728 17. CHD filed a Citizen Petition with the FDA (Exh. 1) on
May 16, 2021, asking the
FDA
to refrain from licensing COVID vaccines and to revoke EUAs for the three
existing
COVID
vaccines. Individuals have submitted over 30,000 comments on this petition.
https://www.regulations.gov/document/FDA-2021-P-0460-0001
18. Pfizer
announced on July 16, 2021 that FDA granted Priority Review designation
for
the Biologics License Application (BLA) for its mRNA vaccine to prevent
COVID-19 in
individuals
16 years of age and older. The announcement noted that the FDA had expanded the
EUA
of the Pfizer-BioNTech COVID-19 vaccine to include individuals 12 years of age
and
older.
(Exh. 2) 19. On August
23, 2021, the FDA granted a license to Pfizer’s “Comirnaty” vaccine
(Exh.
3) and extended the EUA for its Pfizer-BioNTech vaccine. In its letters to
Pfizer and
BioNTech,
the FDA acknowledged that Pfizer’s vaccines are “interchangeable” yet “legally
distinct.”
(Id. at Ftn. 8) It further stated: "The licensed vaccine has the same
formulation as the
EUA-authorized
vaccine and the products can be used interchangeably... The products are
legally
distinct with certain differences that do not impact safety or
effectiveness." 20. The FDA also responded to CHD on August 23, 2021, the
same day it granted the
license
to Pfizer’s Comirnaty and extended the EUA for Pfizer-BioNTech vaccine. (Exh.
4) 21. Although
Defendant Janet Woodcock is the acting commissioner, the fact that she
did
not sign the Pfizer's licensure and EUA extension (Exh. 4), she still bears
responsibility for
the
FDA's actions as pled herein.
Case 1:21-cv-00200 Document 1 Filed 08/31/21
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5 22. FDA failed to convene its outside expert panel to
deliberate on the Pfizer
Comirnaty
licensure. FDA asserted in its licensure letter to Pfizer: (Exh. 5 Page 2) We
did not refer your application to the Vaccines and Related Biological Products
Advisory
Committee because our review of information submitted in you BLA, including
the
clinical study design and trial results, did not raise concerns or
controversial issues
that
would have benefited from an advisory committee discussion. (emphasis added) 23. FDA deliberately misleads the public by confusing the
words approval (implying
licensure)
and authorization (not licensed). "The EUA will continue to cover
adolescents 12
through
15 years of age and the administration of a third dose to certain
immunocompromised
individuals
12 years of age and older. Additionally, for logistical reasons, the EUA will
continue
to
cover the use of the Pfizer-BioNTech COVID 19 Vaccine in individuals 16 years
of age and
older;
this use is also now approved." (Exh. 6) 24. The EUA shields manufacturers from liability for both
"[a]n unapproved drug,
biological
product, or device used under an Emergency Use Authorization (EUA) issued by
FDA;
or [a]n approved drug, biological product, or device used pursuant to Federal
law in
conditions
that are inconsistent with its approval." (Exh. 7) 25. FDA’s representation that licensure of its Comirnaty
vaccine does not “raise
concerns
or controversial issues” (Exh. 5 Page 2) is transparently false. Although Janet
Woodcock
and the FDA have gone to great lengths to obscure its subversion of law, their
actions
speak
for themselves.
ARGUMENT
26. FDA’s actions to simultaneously license Pfizer’s
“Comirnaty” vaccine and to
extend
Pfizer’s EUA for its vaccine that has the “same formulation” and that “can be used
interchangeably”
violates federal law. (Exh. 3)
Case 1:21-cv-00200 Document 1 Filed 08/31/21
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6 27. The law on “Authorization for medical products for use
in emergencies” requires
that
the EUA designation be used only when “there is no adequate, approved, and
available
alternative
to the product for diagnosing, preventing, or treating such disease or condition.”
21 U.S. Code § 360bbb-3-(3) (emphasis added). 28. Once FDA approved and licensed Pfizer’s Comirnaty
vaccine, there was no
further
basis for the FDA to preserve the EUA status for the Pfizer-BioNTech vaccine
that Pfizer
acknowledges
has the “same formulation” and is “interchangeable.” 29. There also is no basis to retain EUA status for other
COVID vaccines for the
same
use and for the same population as Pfizer’s Comirnaty vaccine. FDA’s decision
to evade
these
requirements is arbitrary and capricious. 30. The FDA has failed to abide by its own criteria for
EUA designation; its decision
must
be vacated and remanded. 31. The Administrative Procedures Act (APA) protects the
public from arbitrary and
capricious
executive branch action by imposing the rule of reason and the rule of law
through
judicial
oversight. An agency is “required to engage in reasoned decision making.”
Michigan v.
EPA,
576 U.S. 743, 750 (2015). This requires that the agency “articulate a
satisfactory
explanation
for its action.” Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut.
Auto Ins.
Co.,
463 U.S. 29, 43 (1983). 32. This agency process requires Defendants to articulate
clear rationales for
decisions,
especially when their actions are bound to lead to a medical mandate for
millions of
people.
Burlington Truck Lines v. United States, 371 U.S. 156, 158 (1962). 33. When courts abandon this standard of oversight, the
public is at grave risk. If
pressure
from politicians and profiteers rush regulators to license a biologic and
violate the law,
Case 1:21-cv-00200 Document 1 Filed 08/31/21
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7 debacles predictably unfold and tragedies result. 34. A “reasonable time for agency action is typically
counted in weeks or months, not
years,”
In re Am. Rivers & Idaho Rivers United, 372 F.3d 413, 419 (D.C. Cir. 2004),
and an
agency
action’s exigent context may demand expedited review. Fund for Animals v.
Norton, 294
F.Supp.2d
92, 114 (D.D.C. 2003) (“pressing human health concerns...demand prompt review”).
35. Congress
requires that courts “shall hold unlawful and set aside” any agency
“action,”
“finding,” or “conclusion” whenever the agency failed to follow the necessary
process
for
reasoned decision-making. 5 U.S.C. 706(2)(A). 36. University of Cincinnati v. Shalala, 891 F. Supp.
1262, 1269-1270 found that
[u]nder
this arbitrary and capricious standard, the court must determine "whether
the agency
decision
was based on a consideration of the relevant factors and whether there has been
a clear
error
in judgment." Motor Vehicle Mfrs. Assn. v. State Farm Mutual Auto, Ins.
Co., 463 U.S. 29,
43,
77 L. Ed. 2d 443, 103 S. Ct. 2856 (1983). This standard of review is narrow;
however,
notwithstanding,
"the agency must examine the relevant data and articulate a satisfactory
explanation
for its action including a 'rational connection between the facts found and the
choice
made.'"
Id. (quoting Burlington Truck Lines, Inc. v. United States, 371 U.S. 156, 168,
9 L. Ed.
2d
207, 83 S. Ct. 239 (1962)). If the agency's interpretation is reasonable, the
court must uphold
it
even if the court would have reached a different interpretation had that issue
first been
presented
to it. Tallman, 380 U.S. at 16. However, the court must reject administrative
constructions
that are inconsistent with a statutory mandate, frustrate congressional policy,
or,
otherwise,
not supported by "substantial evidence on the record considered as a
whole." Federal
Election
Com. v. Democratic Senatorial Campaign Committee, 454 U.S. 27, 29-33, 70 L. Ed.
2d
23,
102 S. Ct. 38 (1981); See also State Farm Mutual Auto. Ins. Co., 463 U.S. at
44.
Case 1:21-cv-00200 Document 1 Filed 08/31/21
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8 37. By flagrantly violating federal law, the FDA has
failed to follow reasoned
decision-making.
Pfizer cannot unlawfully reap the benefits of licensure and EUA status
simultaneously,
even if the FDA says it can. This clearly violates Congress’ intent regarding
emergency
medical countermeasures. 38. The FDA has indulged Pfizer to “have it both ways.”
Pfizer now enjoys the
imprimatur
of safety, effectiveness and legality from a license while retaining the
blanket
liability
shield of an EUA product. 39. The documents the FDA made public regarding these
decisions contain tortured,
barely
comprehensible language that fails to explain the “legally distinct”
differences between
the
Pfizer vaccines with differing labels and designations. How can vaccines under
EUA and
license
be “interchangeable” yet “legally distinct?” (Exh. 3 Ftn. 8) 40. This linguistic smokescreen almost certainly conceals
the fact that the available
EUA
product, Pfizer-BioNTech, has a priceless PREP Act liability shield (Exh.7)
while the
unavailable,
licensed vaccine, Comirnaty, does not rightfully have that shield. 41. Once the FDA licensed the Comirnaty vaccine for those
16 and older, it was
legally
obliged to revoke the EUAs for the other COVID vaccines for this age group. Yet
it
failed
to do so. 42. The new
Comirnaty vaccine cannot also be authorized for emergency use for the
first
two doses of vaccines in adults since this is its licensed indication. The
Pfizer Comirnaty
vaccine
should be subject to ordinary product liability when used for the first two
doses of the
vaccine
for adults. 43. Coverage
under the Vaccine Injury Compensation Program, which will eventually
afford
the Comirnaty vaccine substantial liability protection, only occurs when (1)
the vaccine is
Case 1:21-cv-00200 Document 1 Filed 08/31/21
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9 recommended by the Centers for Disease Control and
Prevention for routine administration to
children
and/or pregnant women; (2) Congress enacts an excise tax on the vaccine; and
(3) the
Department
of Health and Human Services adds the vaccine to the Vaccine Injury Table
through
publication
of a notice of coverage in the Federal Register. https://www.hrsa.gov/vaccine-
compensation/covered-vaccines/index.html.
44. The FDA is
creating legal cover for licensed vaccine mandates while gifting
Pfizer
a bullet-proof liability shield that comes only with an EUA. It has tried to
please two
masters:
the Executive Branch, which has insisted on licensed vaccines for pervasive
mandates,
and
Pfizer, which demanded indemnification from any vaccine-related injuries and
deaths. But
the
FDA seems to have forgotten its one true client: the American public. 45. While FDA may argue that Pfizer’s Comirnaty vaccine is
currently unavailable in
the
United States, and thus it is not in violation of the law as the licensed
alternative must be
“available,”
this argument is specious. Pfizer’s Comirnaty vaccine is its primary product in
Europe;
if its two “interchangeable” vaccines are truly so, then Pfizer can relabel its
EUA Pfizer-
BioNTech
vials with Comirnaty labels or vice versa. 46. FDA makes excuses for Pfizer’s lack of availability in
its August 23, 2021 letter
to
Pfizer, stating that “there is not sufficient approved vaccine available for
distribution to this
population
in its entirety at the time of reissuance of this EUA.” (Exh. 3 Ftn. 9) 47. Either Pfizer’s vaccine for those 16 and up is
licensed or it’s not; either it’s EUA,
or
it’s not. It clearly contradicts the law for this product to be both licensed
and authorized
simultaneously.
Such trickery undermines the public’s confidence in the FDA when it so
desperately
needs to have that trust. The FDA's actions also undermine the rule of law. 48. The FDA has arbitrarily and capriciously allowed
Pfizer to play “bait and switch”:
Case 1:21-cv-00200 Document 1 Filed 08/31/21
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10 to represent that Pfizer vaccines are licensed and
available while selling off its inventory of
experimental
vaccines that enjoy blanket liability protection. These FDA actions are
arbitrary,
capricious
and illegal. 49. The FDA’s
licensure of the Pfizer Comirnaty vaccine triggered employer,
military,
educational and institutional mandates across the country, coercing millions of
healthy
individuals
to take unwanted, risky medical interventions. 50. These mandates are creating myriad economic
dislocations, including in
healthcare,
education and law enforcement. Millions will be forced out of jobs and
institutions
rather
than submit to potentially injurious medical interventions. 51. While the finding of “arbitrary and capricious” agency
action is a high bar, and
courts
are appropriately reluctant to second guess administrative action, there are
times when
justice
demands judicial action. Now is such a time.
CAUSE
OF ACTION Failure to Abide by Federal Law as Abuse of Discretion -- APA 5 USC
706 (2) (A)
52. Plaintiffs incorporate the foregoing paragraphs as if
fully set forth herein.
The
FDA's Licensure of Pfizer’s Comirnaty Vaccine is Arbitrary and Capricious
53. An agency’s action is “arbitrary and capricious” if it
did not articulate any rational
connection
between the facts it found and the choices it made. Burlington Truck Lines v.
United
States,
371 U.S. 156, 168. The FDA’s action failed to articulate a lawful rationale. 54. Defendants authorized the Comirnaty vaccine to give
the misleading impression
to
the public that the vaccine that would be mandated is fully approved, when in
fact what is
available,
according to the FDA's own admission is actually the EUA, liability-free
product. 55. Politics
and industry pressure should play no role in the approval and
Case 1:21-cv-00200 Document 1 Filed 08/31/21
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11 authorization process, yet they appear to have been
central in the FDA’s decision-making
process.
56. Defendants
acted arbitrarily and capriciously by failing to engage in a pluralistic,
critical,
open, transparent and scientific dialogue with the public and medical community
based
on
careful, deliberative evaluation of all relevant research before rushing the
approval of this
vaccine.
57. Defendants'
arbitrary and capricious actions warrant vacatur and remand.
PRAYER
FOR RELIEF
WHEREFORE,
Plaintiff s Amy Miller and Children’s Health Defense respectfully
ask
this Court: i. To vacate
and remand the FDA’s decision to license Pfizer’s Comirnaty vaccine
and
to extend its Pfizer-BioNTech Emergency Use Authorization; ii. To award attorneys’ fees and costs, as authorized
under 28 U.S.C. 2412; and iii. To grant
all other appropriate relief as necessary. Dated: August 31, 2021 Respectfully
submitted, __/s/ Derek Jordan_________________ Derek Jordan, Esq. Tennessee Bar
No. 34299 Email: derekjordan@barneslawllp.cm Robert E. Barnes, Esq.
Subject
to admission Pro Hac Vice
Email:
robertbarnes@barneslawllp.com BARNES LAW
700
South Flower Street, Suite 1000 Los Angeles, California 90017 Telephone: (310)
510-6211
Case 1:21-cv-00200 Document 1 Filed 08/31/21
Page 11 of 12 PageID #: 11
12 Ray L. Flores II
Subject
to admission Pro Hac Vice Email: rayfloreslaw@gmail.com 11622 El Camino Real
Suite 100 San Diego, CA 92130 Telephone: (858) 367-0397 Robert F. Kennedy, Jr.,
Esq. Mary S. Holland, Esq.
Subject
to admission Pro Hac Vice
Email:
mary.holland@childrenshealthdefense.org Children’s Health Defense 1227 N.
Peachtree Pkwy, Suite 202 Peachtree City, GA 30269
Counsel
for Plaintiffs CHILDREN’S HEALTH
DEFENSE
and AMY MILLER
Case 1:21-cv-00200 Document 1 Filed 08/31/21
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https://childrenshealthdefense.org/wp-content/uploads/CHD-v.-FDA-Submitted-Complaint-8.31.21.pdf
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