Motion For Preliminary Injunction

Date: 2021-11-19

Summary

A motion for preliminary injunction with supporting brief in America's Frontline Doctors, et al. v. The United States of America, et al., Case No. 2:21-cv-702-CLM, in the U.S. District Court for the Northern District of Alabama, filed November 19, 2021 as Document 37. The plaintiffs move under Rule 65 to enjoin enforcement of Executive Orders 14042 and 14043 and every rule, directive and guidance based on them. The brief relies on three counts of the amended complaint: Count VI, which challenges the statutory basis for the orders; Count II, which asserts a right to bodily integrity; and Count III, which challenges the emergency use authorizations for three COVID-19 vaccines under 21 U.S.C. § 331 and 21 U.S.C. § 352(j). It also addresses irreparable injury, the public interest and standing. The 46-page filing is signed by counsel including Lowell H. Becraft, Jr. and Thomas Renz.

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Case 2:21-cv-00702-CLM Document 37 Filed 11/19/21 Page 1 of 46 FILED
2021 Nov-19 PM 11:28
U.S. DISTRICT COURT
N.D. OF ALABAMA

IN THE UNITED STATES DISTRICT COURT FOR
THE NORTHERN DISTRICT OF ALABAMA

AMERICA’S FRONTLINE )
DOCTORS, et al, )
)
Plaintiffs, )
)
v. ) Case No. 2:21-cv-702-CLM
)
The UNITED STATES OF AMERICA, )
et al, )
)
Defendants. )

MOTION FOR PRELIMINARY INJUNCTION
WITH SUPPORTING BRIEF
Case 2:21-cv-00702-CLM Document 37 Filed 11/19/21 Page 2 of 46

TABLE OF CONTENTS

MOTION FOR PRELIMINARY INJUNCTION . . . . . . . . . . . . . . . . . . . . . . . . . . 1

STANDARD FOR INJUNCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

FACTS RELEVANT FOR THIS MOTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

RELEVANT LEGAL BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

I. Statutory Foundation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

II. The Vaccine Manufacturers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

SUMMARY OF ARGUMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

SUCCESS ON THE MERITS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

I. Count VI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

II. Count II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

III. Count III . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

IRREPARABLE INJURY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

INJURY TO THE UNITED STATES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

THE PUBLIC INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

NOTE ABOUT PLAINTIFFS’ STANDING. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

RELIEF SOUGHT AND CONCLUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

ii
Case 2:21-cv-00702-CLM Document 37 Filed 11/19/21 Page 3 of 46

MOTION FOR PRELIMINARY INJUNCTION

“[T]he sole object and only legitimate end of government is to protect the

citizen in the enjoyment of life, liberty, and property, and when the government

assumes other functions it is usurpation and oppression.” Art. 1, §35, Alabama

Constitution. “[T]his enumeration of certain rights shall not impair or deny others

retained by the people; and, to guard against any encroachments on the rights herein

retained, we declare that everything in this Declaration of Rights is excepted out of

the general powers of government, and shall forever remain inviolate.” Art. 1, §36,

Alabama Constitution.

One right encompassed within the “liberty” provisions of the Alabama

Constitution “includes the right[] . . . to bodily integrity”. Washington v. Glucksberg,

521 U.S. 702, 720 (1997). It is “fundamental in American jurisprudence, that the

individual may control what shall be done with his own body.” Canterbury v. Spence,

150 U.S. App. D.C. 263, 464 F.2d 772, 780 (D.C. Cir. 1972). These liberty interests

include “the right to marry, to have children, to direct the education and upbringing

of one’s children, to marital privacy, * * * [and] to bodily integrity”. Crawford v.

State, 92 So. 3d 168, 171 (Ala. Crim. App. 2011). After all, “[a] competent person has

the constitutional right to choose or refuse medical treatment, and that right extends

to all relevant decisions concerning one’s health.” In re Guardianship of Browning,

568 So. 2d 4, 12 (Fla. 1992).

1
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Last spring on April 29, House Speaker Nancy Pelosi disclaimed the authority

of Congress to impose vaccine mandates,1 but legal events regarding this COVID

pandemic have been quickly evolving ever since. Those who oppose mandatory

vaccines chiefly rely on their constitutional right to control what gets injected into

their bodies, while those who promote the vaccines assert that such is a constitutional

power of government. And the clash between these diametrically opposed contentions

manifested when President Biden issued two Executive Orders on September 9:

Executive Orders 14042 (“EO 14042”) and 14043 (“EO 14043”) (copies of which

are attached hereto as Exs. 1 and 2).

This motion is predicated on several counts in the amended complaint (ECF

32-1). Count VI of that complaint challenges the validity of EO 14042 and EO 14043,

asserting that the statutory foundation for these Orders is inadequate to support what

these Orders seek to accomplish: the imposition of vaccine mandates. In short, this

count contends that President Biden is attempting via these Orders to exercise

legislative power which has not been delegated to him. In Count VI of the amended

complaint, the plaintiffs seek a declaratory judgment regarding the validity of these

Orders.

Count II of the amended complaint is premised on the well recognized right to

1
See: https://www.youtube.com/watch?v=25w0m3p2vCk (last visited Nov.
16, 2021).
2
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“bodily integrity.” In this count, the plaintiffs assert that this constitutional right is

being purposely abridged by these Orders as well as other actions directly arising

from the actions of the defendants, and the plaintiffs contend that because of this

constitutional right, they cannot be forced to take a vaccine over their objection.

In Count III of the amended complaint, the Plaintiffs challenge the “emergency

use authorizations” (herein “EUA”) granted in reference to the 3 vaccines that are

currently being made available and administered to the American public: the

Pfizer-BioNTech vaccine, the Moderna vaccine, and the Johnson & Johnson/Janssen

vaccine. Two federal laws codified at 21 U.S.C. § 331 and 21 U.S.C. § 352(j) make

penal the “misbranding of drugs.”2 By October 22, 2020, the FDA was clearly aware

that the vaccines that had been developed under its supervision and were soon to be

approved were dangerous and likely to cause death to many vaccine recipients, and

this great danger of inordinate deaths has proven to be true. Because of these known

adverse events, plaintiffs believe that the EUAs are invalid and they challenge the

same via this lawsuit.

Pursuant to Rule 65, F.R.Cv.P., the Plaintiffs respectfully move this court for

a preliminary injunction, as further described below, and after hearing, they request

2
As explained infra, “misbranding” essentially means that when a drug or
vaccine is used in the manner as directed on the manufacturer’s product label or
promotional materials but is still dangerous, it is “misbranded.”
3
Case 2:21-cv-00702-CLM Document 37 Filed 11/19/21 Page 6 of 46

that the court grant such.

STANDARD FOR INJUNCTION

In Jones v. Governor of Florida, 950 F.3d 795, 806 (11th Cir. 2020), the

various factors that need to be shown in order for a party to obtain a preliminary

injunction were set forth:

“A district court may grant preliminary injunctive relief only when a party
establishes each of four separate requirements:

“(1) it has a substantial likelihood of success on the merits; (2) irreparable
injury will be suffered unless the injunction issues; (3) the threatened injury to
the movant outweighs whatever damage the proposed injunction may cause the
opposing party; and (4) if issued, the injunction would not be adverse to the
public interest.”

Moreover in a motion for injunctive relief, a party may challenge public health

officials and their various decrees issued in response to an alleged health crisis: “‘if

a statute purporting to have been enacted to protect the public health, the public

morals, or the public safety, has no real or substantial relation to those objects, or is,

beyond all question, a plain, palpable invasion of rights secured by the fundamental

law, it is the duty of courts to so adjudge, and thereby give effect to the

Constitution.’” Robinson v. Attorney General, 957 F.3d 1171, 1178 (11th Cir. 2020)

(quoting Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11 (1905)). After

all, “just as constitutional rights have limits, so too does a state’s power to issue

executive orders limiting such rights in times of emergency.” Id.

4
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FACTS RELEVANT FOR THIS MOTION

Angelia Desselle took a vaccine on January 5, 2021, and has been seriously

injured as a result (ECF 15-8). As she has stated: “I have lost my job, the ability to

drive or go out in public for fear of a convulsion starting. This vaccine has basically

taken my life without killing me.” Shawn Vidiella, a certified nursing assistant, took

a vaccine on January 4, 2021 (ECF 15-9). She “ended up visiting five emergency

rooms and traveled as far away from home as Vanderbilt in Nashville, Tennessee

seeking help. Nobody was able to help me. I was told I had a variety of different

problems: psychogenic movement disorder, conversion disorder, panic attack, PTSD,

stress. On January 11, 2021, I was finally admitted into Deaconess Gateway

Neurology. I was examined by a psychologist before I was even seen by a

neurologist, and an MRI was ordered. The MRI came back normal and I was

discharged. The full-body convulsions were continuous for 12 days. To date, I have

tremors and uncontrollable body movements almost daily. I experience convulsions

several times a week and sometimes several times a day.” She has lost her job, and

was denied worker’s compensation.

Brittany Galvin apparently got COVID-19 in early 2021, and was extremely

sick as a result (ECF 15-10). But because of social pressure, she took the first

Moderna shot on March 28, 2021 and the second one on May 4, 2021. At the time

she signed her declaration submitted in this case, she had been seriously injured and

5
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was at Advent Carrollwood Hospital in Tampa as a patient. “My neurologist gave me

a diagnosis of Guillain Barre Syndrome, Acute Neuropathic POTS, pericarditis,

gastroparesis and aseptic meningitis. He attributes my condition to the shot. I have

already lost the reflects in my ankles and knees. I was told my neurologist made a

report to VAERS.” She considers her decision to take the shot as “the biggest mistake

I have ever made”.

Diane Hallmark received a vaccine shot on February 12, 2021, and another on

March 10 (ECF 15-11). Both she and her husband have been hospitalized as a result

of the shots. “I still needed assistance with basic things such as getting out of bed,

walking and going to the bathroom. I started physical therapy in my daughter’s home

and began to learn to walk and do things once again. I regained some limited

function, but I still struggle with the function of my lower limbs and with vertigo and

dizziness such that I cannot care for myself, or my husband anymore, and probably

never will be able to.”

For good reasons, plaintiffs Jody Sobczak and his wife, Deborah, oppose

compulsory vaccinations as do Lyle Bloom and his wife, Julie (ECF 1-3, 1-4, 1-5, 1-

6). Plaintiff Joseph Makowski works for a Huntsville employer that is requiring its

employees to be vaccinated no later than December 8, 2021 (Ex. 3 attached hereto).

Plaintiffs Michael Nelson and Joseph Leahy both live in Huntsville and work at the

Marshall Space Flight Center, and they confront a vaccine mandate requiring

6
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vaccination by November 22, 2021 (Ex. 4 attached hereto). Both Nelson or Leahy

object to being vaccinated.

Dr. Scott Jensen has stated that “anyone under the age of 17 is at statistically

zero risk of dying of Covid 19 infection.” (ECF 1-1). Nonetheless, there is a present

effort to vaccinate children as young as 5 years of age. Dr. Steven Roth works in a

hospital’s emergency room, and he has stated as follows:

I have not seen a COVID-19 patient in many months, but I am seeing many
patients come to the emergency department patients post-COVID-19 shot. All
of these patients came in with COVID-like symptoms that occurred within 48
hours of the shot.

All of these patients required hospital admission.

Several of these patients progressed to death. From the vaccine. (ECF 1-9).

Dr. Angelina Farella (ECF 15-2), and Dr. Richard Urso (ECF 15-3) have read

and they agree with the facts alleged in the initial complaint filed in this case (ECF

10) and the first motion for a preliminary injunction (ECF 15). Some of these facts

with which they agree are the following (the below numbers correspond to the

paragraph numbers in that amended complaint):

4. The Vaccines appear to be linked to a range of profoundly serious medical
complications, among them myocarditis, miscarriage, irregular vaginal
bleeding, clotting disorders, strokes, vascular damage and autoimmune disease.

***

182. The SARS-CoV-2 has a spike protein on its surface. The spike protein is
what allows the virus to infect other bodies. It is clear that the spike protein is

7
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not a simple, passive structure. The spike protein is a “pathogenic protein” and
a toxin that causes damage. The spike protein is itself biologically active, even
without the virus. It is “fusogenic” and consequently binds more tightly to our
cells, causing harm. If the purified spike protein is injected into the blood of
research animals, it causes profound damage to their cardiovascular system,
and crosses the blood-brain barrier to cause neurological damage.

183. The study reveals that unlike traditional vaccines, this spike protein enters
the bloodstream and circulates throughout the body over several days post-
vaccination. It accumulates in a number of tissues, such as the spleen, bone
marrow, liver, adrenal glands and ovaries. It fuses with receptors on our blood
platelets, and also with cells lining our blood vessels. It can cause platelets to
clump leading to clotting, bleeding and heart inflammation. It can also cross
the blood-brain barrier and cause brain damage. It can be transferred to infants
through breast milk.

***

193. Salk Institute for Biological Studies researchers in collaboration with the
University of San Diego, published in the journal Circulation Research that the
spike proteins themselves damage vascular cells, causing strokes and many
other vascular problems. All the vaccines are causing clotting disorders
(coagulopathy) in all ages. The spike proteins are known to cause clotting that
the body cannot fix, such as brain thrombosis and thrombocytopenia.

***

195. The spike proteins are perceived to be foreign by the human immune
system, initiating an immune response to fight them. While that is the intended
therapeutic principle, it is also the case that any cell expressing spike proteins
becomes a target for destruction by our own immune system. This is an
autoimmune disorder and can affect virtually any organ in the body. It is likely
that some proportion of spike protein will become permanently fused to long-
lived human proteins and this will prime the body for prolonged autoimmune
diseases. Autoimmune diseases can take years to show symptoms and many
scientists are alarmed at giving young people such a trigger for possible
autoimmune disease.

***

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204. The Vaccines induce the cells of the recipient to manufacture trillions of
spike proteins for an undetermined amount of time with the pathology
described above, whereas naturally occurring COVID-19 comes and goes. The
spike protein is the same. The increased risk comes from reprogramming the
cells to permanently create the spike protein at potentially high levels. Because
immune responses in the young and healthy are more vigorous than those in
the old, paradoxically, the vaccines may thereby induce, in the very people
least in need of assistance, a very strong immune response, including those
which can damage their own cells and tissues, including by stimulating blood
coagulation.

***

208. Antibody Dependent Enhancement (“ADE”) occurs when SARS-CoV-2
antibodies, created by a Vaccine, instead of protecting the vaccinated person,
cause a more severe or lethal case of the COVID-19 disease when the person
is later exposed to SARS-CoV-2 in the wild. The Vaccine amplifies the
infection rather than preventing damage. It may only be seen after months or
years of use in populations around the world.

On October 22, 2020, the FDA’s Vaccines and Related Biological Products

Advisory Committee conducted a meeting for various attendees to discuss sundry

matters related to the COVID-19 pandemic. During this meeting, a slide presentation

was given wherein one of slides disclosed the following possible “risks” of the

vaccines:

Guillain-Barré syndrome
Acute disseminated encephalomyelitis
Transverse myelitis
Encephalitis/myelitis/encephalomyelitis/
meningoencephalitis/meningitis/encepholapathy
Convulsions/seizures
Stroke
Narcolepsy and cataplexy
Anaphylaxis

9
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Acute myocardial infarction
Myocarditis/pericarditis
Autoimmune disease
Deaths
Pregnancy and birth outcomes
Other acute demyelinating diseases
Non-anaphylactic allergic reactions
Thrombocytopenia
Disseminated intravascular coagulation
Venous thromboembolism
Arthritis and arthralgia/joint pain
Kawasaki disease
Multisystem Inflammatory Syndrome in Children
Vaccine enhanced disease

See Ex. 5 attached hereto.

However, a few months later when Pfizer, Moderna and Jansen published “Fact

Sheets” where they were obligated to provide vaccine recipients specific information

about the “benefits and risks” of each vaccine, these potential risks were not

mentioned, but were carefully concealed. For example, in the “Fact Sheet” published

by Pfizer, Inc., dated May 10, 2021, the risks” of its vaccine were described in the

following manner (ECF 24-1, page 3):

WHAT ARE THE RISKS OF THE PFIZER-BIONTECH COVID-19
VACCINE?

There is a remote chance that the Pfizer-BioNTech COVID-19 Vaccine could
cause a severe allergic reaction. A severe allergic reaction would usually occur
within a few minutes to one hour after getting a dose of the Pfizer-BioNTech
COVID-19 Vaccine. For this reason, your vaccination provider may ask you
to stay at the place where you received your vaccine for monitoring after
vaccination. Signs of a severe allergic reaction can include:

10
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• Difficulty breathing
• Swelling of your face and throat
• A fast heartbeat
• A bad rash all over your body
• Dizziness and weakness

Side effects that have been reported with the Pfizer-BioNTech COVID-19
Vaccine include:

• severe allergic reactions
• non-severe allergic reactions such as rash, itching, hives, or swelling of the
face
• injection site pain
• tiredness
• headache
• muscle pain
• chills
• joint pain
• fever
• injection site swelling
• injection site redness
• nausea
• feeling unwell
• swollen lymph nodes (lymphadenopathy)
• diarrhea
• vomiting
• arm pain

These may not be all the possible side effects of the Pfizer-BioNTech
COVID-19 Vaccine. Serious and unexpected side effects may occur.
Pfizer-BioNTech COVID-19 Vaccine is still being studied in clinical trials.

In a “Fact Sheet” published by Janssen Biotech Inc., dated April 23, 2021, the

“risks” of its vaccine were described in the following manner (ECF 24-10, pages 3-4):

WHAT ARE THE RISKS OF THE JANSSEN COVID-19 VACCINE?

Side effects that have been reported with the Janssen COVID-19 Vaccine

11
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include:

• Injection site reactions: pain, redness of the skin and swelling.
• General side effects: headache, feeling very tired, muscle aches, nausea, and
fever.

There is a remote chance that the Janssen COVID-19 Vaccine could
cause a severe allergic reaction. A severe allergic reaction would usually
occur within a few minutes to one hour after getting a dose of the Janssen
COVID-19 Vaccine. For this reason, your vaccination provider may ask you
to stay at the place where you received your vaccine for monitoring
after vaccination. Signs of a severe allergic reaction can include:

• Difficulty breathing,
• Swelling of your face and throat,
• A fast heartbeat,
• A bad rash all over your body,
• Dizziness and weakness.

Blood clots involving blood vessels in the brain, abdomen, and legs
along with low levels of platelets (blood cells that help your body stop
bleeding), have occurred in some people who have received the Janssen
COVID-19 Vaccine. In people who developed these blood clots and low levels
of platelets, symptoms began approximately one to two-weeks following
vaccination. Most people who developed these blood clots and low levels of
platelets were females ages 18 through 49 years. The chance of having this
occur is remote. You should seek medical attention right away if you have any
of the following symptoms after receiving Janssen COVID-19 Vaccine:

• Shortness of breath,
• Chest pain,
• Leg swelling,
• Persistent abdominal pain,
• Severe or persistent headaches or blurred vision,
• Easy bruising or tiny blood spots under the skin beyond the site of the
injection.

These may not be all the possible side effects of the Janssen COVID-19
Vaccine. Serious and unexpected effects may occur. The Janssen

12
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COVID-19 Vaccine is still being studied in clinical trials.

In the “Fact Sheet” published by Moderna, Inc., dated March 26, 2021, the

“risks” of its vaccine were described in the following manner (ECF 24-6, page 3):

WHAT ARE THE RISKS OF THE MODERNA COVID-19 VACCINE?

There is a remote chance that the Moderna COVID-19 Vaccine could cause a
severe allergic reaction. A severe allergic reaction would usually occur within
a few minutes to one hour after getting a dose of the Moderna COVID-19
Vaccine. For this reason, your vaccination provider may ask you to stay at the
place where you received your vaccine for monitoring after vaccination. Signs
of a severe allergic reaction can include:

• Difficulty breathing
• Swelling of your face and throat
• A fast heartbeat
• A bad rash all over your body
• Dizziness and weakness

Side effects that have been reported in a clinical trial with the Moderna
COVID-19 Vaccine include:

• Injection site reactions: pain, tenderness and swelling of the lymph nodes in
the same arm of the injection, swelling (hardness), and redness
• General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea
and vomiting, and fever

Side effects that have been reported during post-authorization use of the
Moderna COVID-19 Vaccine include:

• Severe allergic reactions

These may not be all the possible side effects of the Moderna COVID-19
Vaccine. Serious and unexpected side effects may occur. The Moderna
COVID-19 Vaccine is still being studied in clinical trials.

“Established in 1990, the Vaccine Adverse Event Reporting System (VAERS)

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is a national early warning system to detect possible safety problems in U.S.-licensed

vaccines. VAERS is co-managed by the Centers for Disease Control and Prevention

(CDC) and the U.S. Food and Drug Administration (FDA). VAERS accepts and

analyzes reports of adverse events (possible side effects) after a person has received

a vaccination. Anyone can report an adverse event to VAERS. Healthcare

professionals are required to report certain adverse events and vaccine manufacturers

are required to report all adverse events that come to their attention.” 3 But, data from

VAERS that has been carefully concealed reveals a darker and more sinister result of

the vaccines. Since vaccines were provided and administered to the American public

at the start of this year, there have been, just for Medicare recipients, a total of 51,100

deaths, with many from Alabama. See Ex. 6 attached hereto.

It is logical to conclude that improvements in the vaccines were made after the

vaccine manufacturers developed and tested them, and thus the current vaccines are

better than the “test” vaccines. If there have been 51,100 deaths just from Medicare

recipients (a subset of the American public) since the vaccine program started, surely

the deadly nature of these vaccines must have been known to the vaccine

manufacturers as well as the defendants.

3
See: https://vaers.hhs.gov/about.html (last visited Nov. 19, 2021)
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RELEVANT LEGAL BACKGROUND

I. Statutory Foundation.

As a result of the 2001 terrorist attacks, Congress determined that there was a

need for a federal program to respond to any foreign attack using chemical,

biological, radiological, or nuclear agents, and it thus enacted the “Project BioShield

Act of 2004”, Pub L. 108–276, 118 Stat. 835. Provisions of this act amended the

Federal Food, Drug and Cosmetic Act by substantially re-writing 21 U.S.C. 360bbb–3

into its present form (118 Stat. at 853). Pursuant to this section, when the HHS

Secretary determines that there is a “public health emergency, * * * that affects, or

has a significant potential to affect, national security or the health and security of

United States citizens living abroad,” he may implement the powers authorized by

this section, which include permitting “EUAs” for approved vaccines to treat

individuals affected by the health crisis.

The following year via the “Public Readiness and Emergency Preparedness

Act”, Pub L. 109–148, 119 Stat. 2818, Congress amended provisions of the Public

Health Service Act by adding a new section to it, now codified at 42 U.S.C. §

247d–6d. This section provides immunity from suit for “covered persons” during a

“covered countermeasure”, which is a response to a declared national health crisis.

On Friday, October 18, 2019, at The Pierre Hotel in New York City, Event 201

15
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was conducted, which was a global pandemic exercise.4 This careful planning

happened just a little less than two months before events in Wuhan, China, garnered

worldwide attention. On December 31, 2019, “WHO’s Country Office in the People’s

Republic of China picked up a media statement by the Wuhan Municipal Health

Commission from their website on cases of ‘viral pneumonia’ in Wuhan, People’s

Republic of China.”5 By January 25, 2020, the “WHO Regional Director for Europe

issued a public statement outlining the importance of being ready at the local and

national levels for detecting cases, testing samples and clinical management.”

In response, President Trump on January 31, 2020, issued his “Proclamation

on Suspension of Entry as Immigrants and Nonimmigrants of Persons who Pose a

Risk of Transmitting 2019 Novel Coronavirus,”6 that interdicted international travel

from China into the United States. As events developed, the perceived threat posed

by COVID-19 appeared to be increasing, causing President Trump to thereafter issue

his “Proclamation on Declaring a National Emergency Concerning the Novel

4
See: https://www.centerforhealthsecurity.org/event201/about (last visited
Nov. 19, 2021).
5
See WHO Timeline of COVID events:
https://www.who.int/news/item/29-06-2020-covidtimeline (last visited Nov. 19,
2021).
6
See Proclamation 9984, 85 Fed.Reg. 6709 (Feb. 5, 2020).
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Coronavirus Disease (COVID-19) Outbreak” on March 13, 2020.7

“On February 4, 2020, the Secretary determined pursuant to his authority under

section 564 of the FD&C Act that there is a public health emergency that has a

significant potential to affect national security or the health and security of United

States citizens living abroad and that involves a novel (new) coronavirus (nCoV) first

detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV).” 85 Fed.Reg.

7316 (February 7, 2020). Thereafter, various vaccine manufacturers such as Pfizer,

Inc., Johnson and Johnson, and Moderna commenced at “warp speed” research on

vaccines to treat COVID-19, and these efforts were reaching fruition by early

December, 2020.

On December 3, 2020 (85 Fed.Reg. 79190, Dec. 9, 2020), the HHS Secretary

granted immunity for “covered countermeasures” to vaccine manufacturers (“covered

persons”) that he might thereafter authorize to produce and distribute a vaccine. On

December 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine was granted EUA (86

Fed.Reg. 5200, Jan. 19, 2021). The Secretary found that

“it is reasonable to believe that Pfizer-BioNTech COVID-19 Vaccine may be
effective. Additionally, it is reasonable to conclude, based on the totality of the
scientific evidence available, that the known and potential benefits of Pfizer-
BioNTech COVID-19 Vaccine outweigh the known and potential risks of the
vaccine, for the prevention of COVID-19 in individuals 16 years of age and

7
Proclamation 9994, 85 Fed.Reg. 15338 (March 18, 2020).

17
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older” (86 Fed.Reg. at 5203).

But, the EUA for this vaccine imposed various requirements on Pfizer, Inc.,

which included providing critical information about adverse reactions to the vaccine

to VAERS:

F. Pfizer Inc. will report to Vaccine Adverse Event Reporting System
(VAERS):
• Vaccine administration errors whether or not associated with an adverse
event;
• Serious adverse events (irrespective of attribution to vaccination);
• Cases of Multisystem Inflammatory Syndrome in children and adults; and
• Cases of COVID-19 that result in hospitalization or death, that are reported
to Pfizer Inc.
These reports should be submitted to VAERS as soon as possible but no later
than 15 calendar days from initial receipt of the information by Pfizer Inc.8

A few days after the grant of EUA for the Pfizer vaccine, ModernaTX, Inc.,

was granted an EUA for its vaccine, Moderna COVID-19 Vaccine, on December 18,

2020 (86 Fed.Reg. 5211, Jan. 19, 2021). The Secretary made the essential findings

that this vaccine “was believed to be effective” and that the “potential benefits of

Moderna COVID-19 Vaccine outweigh the known and potential risks” (86 Fed.Reg.

at 5212). Further, a duty was also imposed on ModernaTX, Inc., to make reports to

VAERS similar to that for Pfizer (86 Fed.Reg. at 5216).

On February 27, 2021, Janssen Biotech, Inc., was granted an EUA for its

vaccine, Janssen COVID-19 Vaccine (86 Fed.Reg. 28608, May 27, 2021). Again, the

8
86 Fed.Reg. at 5207.
18
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FDA made the essential findings that this vaccine “was believed to be effective” and

that the “potential benefits of Moderna COVID-19 Vaccine outweigh the known and

potential risks” (86 Fed.Reg. at 28620). Finally, a duty was also imposed on Janssen

Biotech, Inc., to make reports to VAERS similar to that for Pfizer (86 Fed.Reg. at

28624).

These “COVID-19 vaccines authorized or approved by the [FDA] effectively

protect vaccinated individuals against severe illness and death from COVID-19” (86

Fed.Reg. 61402-03, Nov. 5, 2021).

II. The Vaccine Manufacturers.

In 1849, two German immigrants, Charles Pfizer and his cousin Charles F.

Erhart formed a company that eventually became Pfizer, Inc., which currently is an

American multinational pharmaceutical and biotechnology corporation with

headquarters in New York City. Its annual revenues exceed that of small countries

like New Zealand.

When developing vaccines, Pfizer has engaged in harmful conduct which has

resulted in lawsuits. In 1996 in Nigeria, its vaccine experiments resulted in the death

and other severe injuries to a number of Nigerian children. As a result, Pfizer was

sued and the Second Circuit described Pfizer’s injurious conduct in Abdullahi v.

Pfizer, Inc., 562 F.3d 163, 169 (2d Cir. 2009):

[I]n April 1996, Pfizer, dispatched three of its American physicians to work

19
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with four Nigerian doctors to experiment with Trovan on children who were
patients in Nigeria’s Infectious Disease Hospital (“IDH”) in Kano, Nigeria.
Working in concert with Nigerian government officials, the team allegedly
recruited two hundred sick children who sought treatment at the IDH and gave
half of the children Trovan and the other half Ceftriaxone, an FDA-approved
antibiotic the safety and efficacy of which was well-established. Appellants
contend that Pfizer knew that Trovan had never previously been tested on
children in the form being used and that animal tests showed that Trovan had
life-threatening side effects, including joint disease, abnormal cartilage growth,
liver damage, and a degenerative bone condition. Pfizer purportedly gave the
children who were in the Ceftriaxone control group a deliberately low dose in
order to misrepresent the effectiveness of Trovan in relation to Ceftriaxone.
After approximately two weeks, Pfizer allegedly concluded the experiment and
left without administering follow-up care. According to the appellants, the tests
caused the deaths of eleven children, five of whom had taken Trovan and six
of whom had taken the lowered dose of Ceftriaxone, and left many others
blind, deaf, paralyzed, or brain-damaged.

This case was later settled.9

In 2002, Pharmacia & Upjohn Company, a Pfizer subsidiary, developed a drug

named Bextra, and started vigorously promoting its sale to its sale force. The start of

this sales program was described as follows in the sentencing memorandum of the

AUSA who brought criminal charges against Pfizer:

Bextra was officially launched at a national meeting for sales representatives
in Atlanta, Georgia from April 9-12, 2002. During this meeting, the sales force
was given a vivid message of how to promote Bextra for the “power” position.
They were inundated with displays of music, light shows, acrobats and dancers.
The marketing managers led the entire audience in thrusting their fists into the
air (the marketing symbol of Bextra) and pounding them against their upraised
hands in unison to symbolize the power of Bextra and to “Power Up” the sales

9
See: https://www.law.com/almID/1202482854504/ (last visited Nov. 16,
2020).
20
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force. Ultimately, simulated large steel doors crash down on the stage, and the
Bextra fist symbol crashed through the doors. The events from the launch
demonstrates the sales frenzy that accompanied Bextra, as the company strove
to make the drug reach “blockbuster” (billion dollar a year sales) status.

Condensing this sordid story, Pharmacia sales representatives promoted Bextra

using false and misleading claims, eventually leading to civil actions being filed by

the United States as well as federal criminal charges in several districts. These civil

and criminal charges were ultimately settled by Pfizer, and the Department of Justice

press release summarized that conclusion:

American pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia &
Upjohn Company Inc. (hereinafter together “Pfizer”) have agreed to pay $2.3
billion, the largest health care fraud settlement in the history of the Department
of Justice, to resolve criminal and civil liability arising from the illegal
promotion of certain pharmaceutical products, the Justice Department
announced today.

Pharmacia & Upjohn Company has agreed to plead guilty to a felony violation
of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to
defraud or mislead. * * * The company will pay a criminal fine of $1.195
billion, the largest criminal fine ever imposed in the United States for any
matter. Pharmacia & Upjohn will also forfeit $105 million, for a total criminal
resolution of $1.3 billion.10

It is reported that since 2000, Pfizer has paid $4,660,896,333 in penalties.11

10
See:
https://www.justice.gov/opa/pr/justice-department-announces-largest-health-care-f
raud-settlement-its-history (last visited Nov. 16, 2021).
11
See:
https://violationtracker.goodjobsfirst.org/prog.php?parent=pfizer&sort=asc (last
visited Nov. 16, 2021).
21
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Johnson & Johnson/Janssen Pharmaceuticals, Inc., have had similar problems.

In April, 2010, the Department of Justice announced that two “Johnson & Johnson

Subsidiaries [agreed] to Pay Over $81 Million to Resolve Allegations of Off-Label

Promotion of Topamax Epilepsy Drug Approved by FDA Promoted for Psychiatric

Uses”.12 In 2012, 37 State Attorneys General reached a similar settlement regarding

the promotion and sale of the drug, Risperdal: “Janssen Pharmaceuticals has agreed

to pay $181 million to settle claims brought against it by Oregon Attorney General

Ellen F. Rosenblum and 36 other Attorneys General alleging that the drug company

used unfair and deceptive practices in marketing Risperdal and three related

anti-psychotic drugs.” 13 In November, 2013, the Department of Justice announced

that “Johnson & Johnson [agreed] to Pay More Than $2.2 Billion to Resolve Criminal

and Civil Investigations”. 14 More recently to address its role in assisting the Opioid

crisis that has recently plagued a number of States in this Union, the New York

12
See:
https://www.justice.gov/opa/pr/two-johnson-johnson-subsidiaries-pay-over-81-mil
lion-resolve-allegations-label-promotion (last visited Nov. 16, 2021).
13
See:
https://www.doj.state.or.us/media-home/news-media-releases/oregon-attorney-gen
eral-and-36-others-reach-181-million-risperdal-settlement/ (last visited Nov. 16,
2021).
14
See:
https://www.justice.gov/opa/pr/johnson-johnson-pay-more-22-billion-resolve-crim
inal-and-civil-investigations (last visited Nov. 16, 2021).
22
Case 2:21-cv-00702-CLM Document 37 Filed 11/19/21 Page 25 of 46

Attorney General announced a $230,000,000 settlement with the company.15 The

company has paid a total of $9,248,447,763 in penalties since 2000.16

Moderna, Inc., was formed in 2010 and has since been primarily devoted to

research and development of vaccines.17 The first product it has EVER distributed to

the American public is its experimental COVID-19 vaccine which is available only

because of its EUA approval. This vaccine is now being sold to a number of countries

around the world, which obviously makes its stockholders happy.

SUMMARY OF ARGUMENT

Count VI of the amended complaint notes that President Biden’s Executive

Orders of September 9, 2021, are based on specifically identified federal laws related

to the acquisition of goods and services by the federal government as well as laws

related to the federal civil service. But, these laws are limited to these purposes, and

cannot provide the essential statutory authority needed to impose vaccine mandates

on private contractors as well as government employees. In short, President Biden’s

Orders are an attempt by him to exercise legislative powers that can only be exercised

15
See:
https://ag.ny.gov/press-release/2021/attorney-general-james-reaches-230-million-s
ettlement-treatment-and-prevention (last visited Nov. 16, 2021).
16
See:
https://violationtracker.goodjobsfirst.org/prog.php?parent=johnson-and-johnson
(last visited Nov. 16, 2021).
17
See: https://en.wikipedia.org/wiki/Moderna (last visited Nov. 16, 2021).
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by Congress, if at all. Because these Orders are invalid and unlawful, the vaccine

mandates based on them are void and unenforceable, and the plaintiffs are entitled to

the requested preliminary injunction.

Count II of the amended complaint concerns the plaintiffs’ fundamental

constitutional right to “bodily integrity” which will be violated and abridged if the

forthcoming vaccine mandates are enforced against the plaintiffs by their employers.

The plaintiffs contend here that even if the defendants as well as the United States

possessed the constitutional power and authority to impose vaccine mandates (which

the plaintiffs deny), that authority cannot be used to transgress and breach this

constitutional right. Just based on the assertion of this constitutional right, the

plaintiffs are entitled to a preliminary injunction.

Count III of the amended complaint focuses on the EUAs themselves, which

the plaintiffs contend are unlawful. Prior to the time of issuance of these EUAs to the

3 vaccine manufacturers, it was known to the defendants that the vaccines were very

harmful, injurious and dangerous. However, this predictable harm to vaccine

recipients was not disclosed by either the vaccine manufacturers or the defendants,

who have repeatedly informed the American public that the vaccines are “safe and

effective”.

While the vaccine manufacturers and a wide variety of federal officials

including the President and the other defendants constantly harp that the vaccines are

24
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“safe and effective,” there is evidence to the contrary. Most recently, VAERS data

indicates that there have been more than 50,000 deaths from the vaccines just among

Medicare recipients. From this simple fact it is easy to infer that the vaccines as first

developed and tested were more dangerous than those being used today. And this

inference leads to something more troubling: the vaccine manufacturers have engaged

in misbranding, a fact known by the defendants.

SUCCESS ON THE MERITS

I. Count VI.

Count VI of the amended complaint asserts that EOs 14042 and 14043 issued

by President Biden on September 9, 2021 have no statutory support and are thus

unlawful. As shown below, the plaintiffs are correct in this regard and are entitled to

relief based on this count alone.

A. The Constitutional Deficiencies of the United States.

Here in America, the police power is vested in the States and not the federal

government. See Wilkerson v. Rahrer, 140 U.S. 545, 554 (1891) (the police power “is

a power originally and always belonging to the States, not surrendered to them by the

general government, nor directly restrained by the constitution of the United States,

and essentially exclusive”); Bohon’s Assignee v. Brown, 101 Ky. 354, 41 S.W. 273

(1897); John Woods & Sons v. Carl, 75 Ark. 328, 87 S.W. 621, 623 (1905); Southern

Express Co. v. Whittle, 194 Ala. 406, 69 So.2d 652, 655 (1915); Shealey v. Southern
25
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Ry. Co., 127 S.C. 15, 120 S.E. 561, 562 (1924) (“The police power under the

American constitutional system has been left to the states. It has always belonged to

them and was not surrendered by them to the general government, nor directly

restrained by the constitution of the United States. * * * Congress has no general

power to enact police regulations operative within the territorial limits of a state”);

and McInerney v. Ervin, 46 So.2d 458, 463 (Fla. 1950).

The police power of the States forms “a portion of that immense mass of

legislation which embraces everything within the territory of a State not surrendered

to the General Government; all which can be most advantageously exercised by the

States themselves. Inspection laws, quarantine laws, health laws of every description,

as well as laws for regulating the internal commerce of a State, and those which

respect turnpike roads, ferries, &c., are component parts of this mass.” Gibbons v.

Ogden, 22 U.S. 1, 203 (1824).

This police power encompasses the power of the states to regulate the practice

of medicine, not the federal government or its officers, agents and employees. See

Linder v. United States, 268 U.S. 5, 18 (1925) (“Obviously, direct control of medical

practice in the states is beyond the power of the federal government”); Lambert v.

Yellowley, 272 U.S. 581, 598 (1926)(“It is important also to bear in mind that ‘direct

control of medical practice in the States is beyond the power of the Federal

Government.’ * * * Congress, therefore, cannot directly restrict the professional

26
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judgment of the physician or interfere with its free exercise in the treatment of

disease. Whatever power exists in that respect belongs to the states exclusively.”); Du

Vall v. Board of Medical Examiners, 49 Ariz. 329, 335, 66 P.2d 1026 (1937)(“The

Congress, under the federal Constitution, has power to levy a tax upon narcotics and

their sale, but the states have not delegated to the United States the power to regulate

such sales and to punish therefor, or to regulate the practice of medicine.”); Ghadiali

v. Delaware State Medical Society, 48 F.Supp. 789 (D.Del. 1943)(the practice of

medicine is a State concern); F.T.C. v. Simeon Management Corp., 391 F.Supp. 697

(N.D.Cal. 1975), affirmed at 532 F.2d 708 (9th Cir. 1976); United States v. Evers,

453 F.Supp. 1141, 1150 (M.D.Ala. 1978); Conant v. Walters, 309 F.3d 629, 639 (9th

Cir. 2002); and Oregon v. Ashcroft, 368 F.3d 1118, 1124 (9th Cir. 2004).

B. The unconstitutional exercise of legislative power by President Biden.

In EO 14042, President Biden claimed that the profound power he was

exercising was authorized by the Federal Property and Administrative Services Act,

40 U.S.C. § 101, et seq., as well as 3 U.S.C. § 301. By means of these laws, the

President claimed that he could mandate that a medically injured young man engaged

in sanitation work at a federal facility in Huntsville, Alabama, could be compelled to

take a vaccine contrary to the instructions of that man’s doctor.

In EO 14043, President Biden asserted that sections 3301, 3302, and 7301 of

title 5, United States Code, which relate to the federal civil service and the hiring of

27
Case 2:21-cv-00702-CLM Document 37 Filed 11/19/21 Page 30 of 46

federal employees, gave him the authority to mandate the imposition of vaccines.

According to President Biden, he can force two men working for NASA to be

subjected to harmful vaccines notwithstanding their assertion of their fundamental

constitutional right to bodily integrity as well as their religious objections.

The legal principle that a legislature cannot delegate the power to make law to

an executive official has common law origins, to be very briefly addressed here. King

Henry VIII issued a number of unpopular Proclamations during his reign in England,

and subsequent monarchs similarly abused this privilege. Eventually with the Case

of Proclamations, 77 ER 1352 (1611), Sir Edward Coke, Chief Justice of the King’s

Bench, was asked to decide the legality of one proclamation. Coke and his fellow

judges declared that “the King by his proclamation or other ways cannot change any

part of the common law, or statute law, or the customs of the realm* * * also the King

cannot create any offence by his prohibition or proclamation, which was not an

offence before, for that was to change the law, and to make an offence which was not

* * * ergo, that which cannot be punished without proclamation, cannot be

punished with it.” Id. As such, he held that the challenged proclamation was “utterly

against law and reason, and for that void.” Id.

Based on this history, John Locke, one of the most influential of Enlightenment

thinkers, wrote in his Second Treatise of Civil Government, Chap. XI (1690):

The legislative cannot transfer the power of making laws to any other hands.
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For it being but a delegated power from the people, they, who have it, cannot
pass it over to others. * * * And when the people have said, We will submit to
rules, and be govern’d by laws made by such men, and in such forms, no body
else can say other men shall make laws for them; nor can the people be bound
by any laws but such as are enacted by those, whom they have chosen, and
authorised to make Laws for them. The power of the legislative being derived
from the people by a positive voluntary grant and institution, can be no other,
than what the positive grant conveyed, which being only to make laws, and not
to make legislators, the legislative can have no power to transfer their authority
of making laws, and place it in other hands.

Here in America, the “Federal Constitution and State Constitutions of this

country divide the governmental power into three branches. * * * [I]n carrying out

that constitutional division * * * it is a breach of the National fundamental law if

Congress gives up its legislative power and transfers it to the President, or to the

Judicial branch, or if by law it attempts to invest itself or its members with either

executive power or judicial power.” J. W. Hampton, Jr., & Co. v. United States, 276

U.S. 394, 405-406 (1928). James Madison noted in Federalist No. 47 that delegating

legislative power to an executive too often results in tragedy: “The accumulation of

all powers, legislative, executive, and judiciary, in the same hands * * * may justly

be pronounced the very definition of tyranny.”18

18
It may very well be that Madison acquired this idea from Coke, who wrote:
“Wherever law ends, tyranny begins, if the law be transgressed to another’s harm; and
whosoever in authority exceeds the power given him by the law, and makes use of the
force he has under his command to compass that upon the subject which the law
allows not, ceases in that to be a magistrate * * *.” Section 202 of Chap. XVIII “Of
Tyranny” in Book II of the Two Treatises of Government.
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This problem of executive officials adopting “codes” or regulations to address

and resolve health crises in their states has been the subject of several state cases. In

State v. Marana Plantations, 75 Ariz. 111, 115, 252 P.2d 87 (1953), at issue were

state health regulations applicable to agricultural labor camps. The Arizona Supreme

Court concluded that these sanitary regulations were unconstitutional:

We think that the attempt by the legislature to make it the duty of the board to
“formulate general policies affecting the public health” and to give the board
unrestrained power to regulate sanitation and sanitary practices and promote
public health and prevent disability and mortality is a constitutional
relinquishment of its legislative power and to such extent is violative of
constitutional principles, and the so-called Sanitary Code applicable to
agricultural labor camps is void.

See also Schaezlein v. Cabaniss, 135 Cal. 466, 471, 67 P. 755 (1902); and Boreali v.

Axelrod, 71 N.Y.2d 1, 6, 517 N.E.2d 1350 (1987)(“We hold that the Public Health

Council overstepped the boundaries of its lawfully delegated authority when it

promulgated a comprehensive code to govern tobacco smoking in areas that are open

to the public.”).19

“The Congress manifestly is not permitted to abdicate or to transfer to others

the essential legislative functions with which it is thus vested.” Panama Refining

Some older cases have invalidated cattle quarantines on the same basis. See
19

Reims v. State, 17 Ala. App. 128, 82 So. 576 (1919); Abbott v. State, 106 Miss. 340,
63 So. 667 (1913); and Ex parte Leslie, 87 Tex. Crim. 476, 223 S.W. 227 (1920).
Two interesting cases on different issues are Long v. State, 202 Ga. 235, 237, 42
S.E.2d 729 (1947); and DePetrillo v. Coffey, 118 R.I. 519, 376 A.2d 317 (1977).
30
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Company v. Ryan, 293 U.S. 388, 421 (1935). It “cannot delegate legislative power to

the President to exercise an unfettered discretion to make whatever laws he thinks

may be needed or advisable for the rehabilitation and expansion of trade or industry.”

Schechter Poultry Corp. v. United States, 295 U.S. 495, 537-38 (1935). See also

Carter v. Carter Coal Co., 298 U.S. 238, 310–12 (1936), as well as Youngstown

Sheet & Tube Co. v. Sawyer, 343 U.S. 579 (1952), which found President Truman’s

takeover of steel mills unconstitutional because he lacked statutory authority.

This constitutional principle that the chief executive of a state or our country

cannot exercise legislative powers has arisen and been addressed during this

supposed COVID pandemic crisis. In Midwest Inst. of Health, PLLC v. Governor of

Mich. (In re Certified Questions from the United States Dist. Court), 506 Mich. 332,

958 N.W.2d 1 (2020), that court found various actions of Michigan’s governor

unconstitutional (“it is one thing if a statute confers a great degree of discretion, i.e.,

power, over a narrow subject; it is quite another if that power can be brought to bear

on something as ‘immense’ as an entire economy.”).

Also last year, the Centers for Disease Control devised a moratorium on tenant

evictions, but that agency action was held unconstitutional in Tiger Lily, LLC v.

United States Dept. of Housing and Urban Development, 992 F.3d 518 (6th Cir.

2021). A D.C. district court held similarly in Ala. Ass’n of Realtors v. U. S. Dept. of

Health and Human Services, No. 20-cv-3377 (DLF), 2021 U.S. Dist. LEXIS 85568

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(D.D.C. May 5, 2021), and the Supreme Court upheld that decision in Ala. Ass’n of

Realtors v. United States Dept. of Health and Human Services, No. 21A23, 2021 U.S.

LEXIS 3679 (Aug. 26, 2021).

II. Count II.

Most states have existing laws generally defining the practice of medicine as

encompassing the treatment or cure of a disease. For example, Ala. Code § 34-24-50

defines the practice of medicine to include “diagnos[ing], treat[ing], correct[ing],

advis[ing] or prescrib[ing] for any human disease, * * * by any means or

instrumentality”. As shown supra, the federal government lacks the constitutional

power to regulate the practice of medicine. However, via a number of EUAs issued

during this supposed COVID pandemic, this is precisely what the federal government

has attempted.

In the “Fourth Amendment to the Declaration Under the Public Readiness and

Emergency Preparedness Act for Medical Countermeasures Against COVID–19 and

Republication of the Declaration,” 85 Fed.Reg. 79190 (Dec. 9, 2020), the HHS

Secretary stated the following when once again extending tort protection to “Covered

Persons”:

The amended Section VII adds that PREP Act liability protections also extend
to Covered Persons for Recommended Activities that are related to any
Covered Countermeasure that is:
(a) Licensed, approved, cleared, or authorized by the Food and Drug
Administration (FDA) (or that is permitted to be used under an Investigational

32
Case 2:21-cv-00702-CLM Document 37 Filed 11/19/21 Page 35 of 46

New Drug Application or an Investigational Device Exemption) under the
Federal Food, Drug, and Cosmetic (FD&C) Act or Public Health Service
(PHS) Act to treat, diagnose, cure, prevent, mitigate or limit the harm from
COVID–19, or the transmission of SARS–CoV–2 or a virus mutating
therefrom.20

This tort protection has not only been extended to the vaccine manufacturers,

but also to any and all people, firms and corporations (including pharmacists)

involved in any way with the administration of vaccines to vaccine recipients in the

States. And all of this is funded by the Coronavirus Aid, Relief, and Economic

Security Act or, CARES Act, which was passed by Congress on March 27, 2020.

Public Law 116–136, 134 Stat. 281.

When this COVID pandemic started, one of the first industries to assert legal

challenges to various restrictions imposed by state governments when they attempted

to “flatten the curve” was the abortion industry. In the Spring of 2020, Dr. Scott

Harris, Alabama’s State Health Officer, imposed restrictions on abortionists, who

were quick to sue. That case was resolved by a decision of the 11th Circuit in

Robinson v. Attorney General, 957 F.3d 1171, 1178 (11th Cir. 2020), previously

noted. What the 11th Circuit held there is worth repeating a second time: “‘if a statute

purporting to have been enacted to protect the public health, the public morals, or the

public safety, has no real or substantial relation to those objects, or is, beyond all

20
85 Fed.Reg. at 79194.
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Case 2:21-cv-00702-CLM Document 37 Filed 11/19/21 Page 36 of 46

question, a plain, palpable invasion of rights secured by the fundamental law, it is the

duty of courts to so adjudge, and thereby give effect to the Constitution.’”

An abortion involves the extraction of a human being from a woman’s body,

and the courts provide protection to this constitutionally recognized procedure.

Vaccination involves injecting a chemical into a human’s body, and one must be very

certain of the chemicals that are in that injection to avoid any adverse ramifications.

From a constitutional perspective the difference is striking. In the instance of

abortion, the courts have made clear that the imposition of laws that interfere with the

right to kill a fetus are unconstitutional. Yet here the defendants seem to be

proclaiming that they may mandate a procedure based on an experimental injection.

Are we to believe that the fundamental right to control our bodies is to be recognized

when it comes to efforts such as preventing abortion, but this fundamental right to

control our bodies does not apply to efforts such as the injection of chemicals into our

bodies?

This fundamental constitutional right to bodily integrity must be considered.

In the words of the Robinson court, this is “a plain, palpable invasion of rights

secured by the fundamental law, it is the duty of courts to so adjudge, and thereby

give effect to the Constitution.’”

III. Count III.

“It is axiomatic that physicians are expected to do no harm. When a physician

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breaches that duty and puts his own interests above those of his patients, great harm

can occur. Though the regulation of the practice of medicine is delegated to the states,

when a physician misuses medical devices and threatens public health, the physician

may run afoul of the Federal Food, Drug, and Cosmetic Act”. United States v.

Kaplan, 836 F.3d 1199, 1204 (9th Cir. 2016). The same applies to vaccine

manufacturers.

The federal laws regulating the manufacture, sale and distribution of vaccines

are predicated on the constitutional power of Congress to regulate interstate

commerce (21 U.S.C. § 331). Further, the crime of “misbranding” is the subject of 21

U.S.C. § 352(j), and it provides that a drug is misbranded “[i]f it is dangerous to

health when used in the dosage or manner, or with the frequency or duration

prescribed, recommended, or suggested in the labeling thereof.”

On October 22, 2020, the FDA possessed a list of probable harms of the 3

different vaccines that would be approved within the next few months, and that list

included the utmost harm: death. Probably within a month of this FDA meeting,

Pfizer, Johnson and Johnson, and Moderna submitted applications to it to get their

vaccines EUA approved. Once these vaccines were approved, these companies

published Fact Sheets which ignored these harms and failed to even mention them.

However, there now is evidence that there have been in excess of 50,000 deaths

from these vaccines just among Medicare recipients. Thus, there has been

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concealment of the harms of these vaccines, which constitutes “misbranding.” See

Kordel v. United States, 335 U.S. 345 (1948).

Pfizer and Johnson & Johnson are well aware of what constitutes misbranding

because they both have been charged with violations of 21 U.S.C. § 352(j), and they

plead guilty to those charges. Some years after these misbranding convictions, these

companies submitted EUA applications to the FDA to obtain approval for their

vaccines, as did Moderna. At the time these 3 applications were submitted, the FDA

clearly knew of the probable harms of these vaccines because they were the subject

of the October 22, 2020, seminar at the FDA. Since these vaccine manufacturers later

published Facts Sheets which failed to reveal these harms, it may be inferred that the

applications for EUA approval likewise omitted this vital information. Nonetheless,

the FDA approved the EUA applications, and thus participated in concealing this

extremely important information about the vaccine harms, all in violation of 21

U.S.C. § 352(j).

The defendants assert as a defense here that via 21 U.S.C. U.S.C. §360bbb–3

(i), the approval of the EUAs for these vaccines is subject to their absolute discretion,

which prevents review of these EUAs in this case. However, here the FDA and the

defendants abused their statutory discretion, which consequently permits review here.

A federal court may “invalidate agency action not only if it conflicts with an agency’s

own statute, but also if it conflicts with another federal law.” Nextwave Personal

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Communications, Inc. v. FCC, 254 F.3d 130, 149 (D.C. Cir. 2001), aff’d, 537 U.S.

293, 300 (2003). Here, the FDA was subject to 21 U.S.C. § 352(j), yet violated it

when it approved these vaccines.

The plaintiffs will succeed in their claim asserted in Count III.

IRREPARABLE INJURY

Within the last few weeks, OSHA has promulgated what is best characterized

as its own COVID vaccination program (86 Fed.Reg. 61402, Nov. 5, 2021). Pursuant

to the manner by which challenges are made to OSHA regulations, a number of states

and companies affected by them filed petitions for review with the Fifth Circuit. On

November 12, 2021, the Fifth Circuit enjoined OSHA’s implementation of those rules

pending further review. See BST Holdings, LLC v. OSHA, Case No. 21-60845. The

rationale for the holding in this case involved due process principles; but the Fifth

Circuit also found that implementation of that OSHA imposed vaccine program

abridged fundamental constitutional rights, the violation of which “unquestionably

constitutes irreparable harm.” (Page 19 of order).

It is “the alleged violation of a constitutional right that triggers a finding of

irreparable harm.” Jolly v. Coughlin, 76 F.3d 468, 473 (2d Cir. 1996). See also

Mitchell v. Cuomo, 748 F.2d 804, 806 (2d Cir. 1984)(“‘When an alleged deprivation

of a constitutional right is involved, most courts hold that no further showing of

irreparable injury is necessary.’”); Deerfield Med. Ctr. v. City of Deerfield Beach, 661

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Case 2:21-cv-00702-CLM Document 37 Filed 11/19/21 Page 40 of 46

F.2d 328, 338 (5th Cir. Unit B. 1981)(“It is well settled that the loss of First

Amendment freedoms for even minimal periods of time constitutes irreparable injury

justifying the grant of a preliminary injunction.”); Johnson v. Bergland, 586 F.2d 993,

995 (4th Cir. 1978)(“Violations of first amendment rights constitute per se irreparable

injury.”); and Citizens for a Better Environment v. City of Park Ridge, 567 F.2d 689,

691 (7th Cir. 1975)(“temporary deprivation of First Amendment rights constitutes

irreparable harm in the context of a suit for an injunction.”).

Here, its is perfectly clear that the fundamental constitutional right at issue is

that of the plaintiffs’ “bodily integrity”. “[T]he ‘liberty’ protected by the Due Process

Clause [of the Fourteenth Amendment] includes the right[] . . . to bodily integrity”.

Washington v. Glucksberg, 521 U.S. 702, 720 (1997). “Involuntarily subjecting

nonconsenting individuals to foreign substances with no known therapeutic value —

often under false pretenses and with deceptive practices hiding the nature of the

interference — is a classic example of invading the core of the bodily integrity

protection.” Guertin v. Michigan, 912 F.3d 907, 921 (6th Cir. 2019). Forcing the

plaintiffs to take a shot against their will obviously violates this fundamental

constitutional right, and the plaintiffs have demonstrated irreparable harm.

INJURY TO THE UNITED STATES

The third factor needed to be shown when a party seeks an injunction relates

to the harm, if any, that might be suffered by the party to be enjoined. But when an

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injunction against a government is sought, this and the fourth factor are merged. See

Nken v. Holder, 556 U.S. 418, 420 (2009) (“[t]he third and fourth factors, harm to the

opposing party and the public interest, merge when the Government is the opposing

party”); and Gonzalez v. Governor of Georgia, 978 F.3d 1266, 1271 (11th Cir. 2020).

THE PUBLIC INTEREST

As discussed supra, the vaccines currently being offered to the American

public are harmful. But now on the eve of these dangerous shots becoming

mandatory, the plaintiffs object, seeking to protect their fundamental constitutional

right to bodily integrity. But to show entitlement to an injunction, they must persuade

this court that it is in the public interest for this vaccine program to be shut down. The

plaintiffs have clearly shown facts demonstrating that it is indeed in the public

interest to do so.

Two of the vaccine manufacturers, Pfizer and Johnson and Johnson, have

previously been prosecuted for the federal offense of misbranding. They have also

paid what has been reported as the largest fines in the history of the United States

(perhaps the world). In the aggregate, they have paid penalties in the billions since

the year 2000. It is probably fair to state that it would be extremely difficult to find

any other American company that has paid more.

While these companies are extremely profitable, they certainly will be more

profitable as the direct result of this COVID pandemic. They have contracts with

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countries around the world, as well as the United States, to produce these vaccines

at a price for each shot between $18 and $19.21 When you multiply this price per spot

with the millions of shots they will produce, it is clear that the results of this

pandemic will be billions in the bank accounts of the vaccine manufacturers.

But, there is also the troubling matter of violations of federal law, specifically

that of misbranding. There is evidence indicating that as many as 50,000 Medicare

recipients who took the shot have died as a result. This leads to the conclusion that

it is very probable that the vaccines have always been this dangerous, especially when

the manufacturers were developing and testing them. Why is this fact concealed?

This large number of adverse consequences of the vaccines, clearly known by

the manufacturers, must certainly have been known by the defendants, the FDA, and

other officers, employees and agents of the United States. Knowledge of these

adverse consequences clearly demonstrates that the defendants, to one degree or

another, looked the other way and ignored the violations of the law by the vaccine

manufacturers.

“There is generally no public interest in the perpetuation of unlawful agency

action.” League of Women Voters v. Newby, 838 F.3d 1, 12 (D.C. Cir. 2016). “[T]he

21
See:
https://www.nytimes.com/2020/12/18/upshot/coronavirus-vaccines-prices-europe-
united-states.html (last visited on Nov. 19, 2021)
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Case 2:21-cv-00702-CLM Document 37 Filed 11/19/21 Page 43 of 46

public interest lies in a correct application of the federal constitutional and statutory

provisions upon which the claimants have brought this claim”. Coalition to Defend

Affirmative Action v. Granholm, 473 F.3d 237, 252 (6th Cir. 2006).22

NOTE ABOUT PLAINTIFFS’ STANDING

All counts in the amended complaint are predicated on 5 U.S.C. §702, which

has its own unique subset of standing rules based on various decisional authorities.

In Abbott Labs. v. Gardner, 387 U.S. 136, 153 (1967), the Supreme Court identified

the parties who have standing to institute suits against federal agencies to challenge

their actions:

“Where the legal issue presented is fit for judicial resolution, and where a
regulation requires an immediate and significant change in the plaintiffs’
conduct of their affairs with serious penalties attached to noncompliance,
access to the courts under the Administrative Procedure Act and the
Declaratory Judgment Act must be permitted, absent a statutory bar or some
other unusual circumstance, neither of which appears here.”

See also Ciba-Geigy Corp. v. EPA, 801 F.2d 430, 436 (D.C. Cir. 1986)(“Once the

22
See also ACLU v. Alvarez, 679 F.3d 583, 590 (7th Cir. 2012) (“[T]he public
interest is not harmed by preliminarily enjoining the enforcement of a statute that is
probably unconstitutional.”); Pursuing Am.’s Greatness v. F.E.C., 831 F.3d 500, 511
(D.C. Cir. 2016)(“[E]nforcement of an unconstitutional law is always contrary to the
public interest.”); G & V Lounge, Inc. v. Mich. Liquor Control Comm’n, 23 F.3d
1071, 1079 (6th Cir. 1994) (“[I]t is always in the public interest to prevent the
violation of a party’s constitutional rights.”); and Planned Parenthood Ass’n v. City
of Cincinnati, 822 F.2d 1390, 1400 (6th Cir. 1987)(“Finally, the last factor —
whether the public interest is served by the injunction — is also met, since the public
is certainly interested in the prevention of enforcement of ordinances which may be
unconstitutional.”).
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agency publicly articulates an unequivocal position * * * and expects regulated

entities to alter their primary conduct to conform to that position, the agency has

voluntarily relinquished the benefit of postponed judicial review.”); Appalachian

Power Co. v. EPA, 208 F.3d 1015, 1021 (D.C. Cir. 2000)(“If an agency acts as if a

document issued at headquarters is controlling in the field, if it treats the document

in the same manner as it treats a legislative rule, if it bases enforcement actions on the

policies or interpretations formulated in the document, if it leads private parties or

State permitting authorities to believe that it will declare permits invalid unless they

comply with the terms of the document, then the agency’s document is for all

practical purposes ‘binding.’”); and Union Pac. R.R. Co. v. Surface Transp. Bd., 358

F.3d 31, 35 (D.C. Cir. 2004)(“For an order to be final, two conditions must be

satisfied: the order must not be ‘tentative’ or ‘interlocutory’ in nature, and it must be

an action in which ‘rights or obligations have been determined’ or from which ‘legal

consequences will flow.’”

In this case, the employers of the plaintiffs clearly believe that the challenged

executive orders of President Biden are binding and mandatory, and that the EUAs

are valid enough to warrant the imposition of vaccines on all employees. While it is

is not the defendants who are actually instructing the plaintiffs to get the shot, the

defendants actions and legal directives are the foundation of the employers’ demands,

and the defendants are not absolved of any responsibility. “[M]ere indirectness of

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causation is no barrier to standing, and thus, an injury worked on one party by another

through a third party intermediary may suffice.” National Wildlife Federation v.

Hodel, 839 F.2d 694, 705 (D.C. Cir. 1988).

RELIEF SOUGHT AND CONCLUSION

The plaintiffs assert that they have very valid claims set forth in Counts VI, II

and III of their amended complaint and they have clearly shown that they are entitled

to a preliminary injunction herein. They move the court for a preliminary injunction

enjoining enforcement of EOs 14042 and 14043, and every rule, directive, and

guidance based thereon.

Respectfully submitted this the 19th day of November, 2021.

/s/ Lowell H. Becraft, Jr. /s/ Thomas Renz
Lowell H. Becraft, Jr. Thomas Renz
Attorney for Plaintiffs Attorney for Plaintiffs
ASB 5005-F66L Ohio Bar No. 98645
403C Andrew Jackson Way 1907 W. State St. #162
Huntsville, AL 35801 Fremont, OH 43420
256-533-2535 419-351-4248
becraft@hiwaay.net renzlawllc@gmail.com

/s/ Michael A. Hamilton /s/ F. R. Jenkins
Michael A. Hamilton F. R. Jenkins
Attorney for Plaintiffs Attorney for Plaintiffs
KY Bar No. 89471 Maine Bar No. 004667
HAMILTON & ASSOCIATES Meridian 361 International Law
1067 N. Main St, PMB 224 Group, PLLC
Nicholasville, KY 40356 97A Exchange Street, Suite 202
859-655-5455 Portland, ME 04101

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Case 2:21-cv-00702-CLM Document 37 Filed 11/19/21 Page 46 of 46

michael@cornerstoneattorney.com 866-338-7087
jenkins@meridian361.com

/s/ N. Ana Garner /s/ Joey Gilbert
N. Ana Garner Joey Gilbert
Attorney for Plaintiffs Attorney for Plaintiffs
Garner Law Firm Joey Gilbert Law
206 W. Main Street 405 Marsh Avenue
Farmington, NM 87401 Reno, Nevada 89509
505-930-5170 775-210-1501
garnerlaw@yahoo.com joey@joeygilbertlaw.com

/s/ Robert J. Gargasz
Robert J. Gargasz
Attorney for Plaintiffs
Ohio Bar ID: 0007136
1670 Cooper Foster Park Rd.
Lorain, Ohio 44053
440-960-1670
rjgargasz@gmail.com

CERTIFICATE OF SERVICE

I hereby certify that on this date, November 19, 2021, I electronically
transmitted this pleading to the Clerk of the Court using the CM/ECF system for
filing, which will send notification of such filing to all counsel for the parties in this
case.

/s/ Lowell H. Becraft, Jr.
Lowell H. Becraft, Jr.

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Motion For Preliminary Injunction

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