20210907 Vu Kien FDA

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

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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
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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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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
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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.
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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)
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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,
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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.
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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
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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”:
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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
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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
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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
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