Amicus Curiae Brief — Beth Boyd, et al., Petitioners v. Shriners Hospitals for Children, et al.

No. 26-220

In the

Supreme Court of the United States

________________________

BETH BOYD., et al.,

Petitioners,

v.

SHRINERS HOSPITALS FOR CHILDREN, et al.,

Respondents.

________________________

On Petition for a Writ of Certiorari to the United

States Court of Appeals for the Third Circuit

Amici Curiae Brief of America’s Frontline

Doctors and Dr. Simone Gold, M.D., J.D., in

Support of Petitioners for Reversal

DAVID A. DALIA, Attorney at Law

700 Camp Street

New Orleans, LA 70130

(504) 524-5541

davidadalia@gmail.com

Counsel for Amici Curiae

–i–

TABLE OF CONTENTS

TABLE OF AUTHORITIES ...............................................iv

A MATTER OF GREAT PUBLIC IMPORTANCE ................... 1

INTEREST OF AMICI CURIAE .......................................... 2

SUMMARY OF ARGUMENT .............................................. 3

ARGUMENT .................................................................... 5

I.

II.

The CDC’s operational guidance for

nationwide COVID-19 vaccine distribution relied upon a web of binding

agreements among federal, state, and

local

governments

and

frontline

providers to ensure that the COVID-19

vaccination program was implemented

in adherence with all federal guidance,

requirements and constraints. All actors

involved in the federal distribution

program were contractually and legally

bound

to

comply

with

federal

constitutional and statutory rights,

obligations, and rules concerning

experimental, investigational drugs.

Respondents violated binding informed

consent

and

experimental

drug

regulations...................................................... 5

Cruzan v. Dir., Mo. Dep’t of Health

requires personal medical treatment

decisions to be strictly voluntary and

free from coercion or pressure. The

– ii –

courts below erred in allowing

Respondents to evade their state and

federal contractual responsibilities to

follow applicable federal constitutional

and statutory provisions as Program

participants or as private parties by

coercively “mandating” a dangerous

experimental treatment which does not

prevent infection or transmission, and

which has severe undisclosed side

effects, including death. ................................. 9

III.

Respondents’ illegal mandates under

coercive threat of loss of employment

violates

informed

consent,

wellestablished constitutional provisions,

and numerous civil and criminal laws

and regulations. Governments are

increasingly recognizing such mandates

as irrational and against public policy........ 12

IV.

It is undisputed that the mandated

experimental, investigational mRNA

injectable drugs have shockingly high

fatality rates. The CDC’s own reporting

system has documented millions of

adverse reactions, disabilities and

hospitalizations and a tragic 39,205

fatalities attributable to these mRNA

injections through July 31, 2026.

Previously, a vaccine would be pulled

from the market after only a few deaths.

A medical mandate to take an

experimental injection is against public

policy............................................................. 17

– iii –

V.

“Mandating” dangerous experimental

drugs — drugs never approved by the

FDA, despite erroneous media reports

to the contrary — absent voluntary,

coercion-free informed consent violates

well-established constitutional principles, including the rights to refuse

medical treatment and of personal

bodily integrity; violates civil and

criminal federal and state laws

prohibiting medical battery, negligent

injuring,

assault,

and

negligent

homicide; and violates numerous federal

regulations requiring informed consent

and full disclosure, including 21 U.S.C.

§360bbb-3, 21 C.F.R. §50.20, 21 C.F.R.

§50.25, 45 C.F.R. §46.116, and the

Nuremberg Code. ......................................... 23

CONCLUSION ............................................................... 28

– iv –

TABLE OF AUTHORITIES

CASES

PAGE(S)

Canterbury v. Spence,

464 F.2d 772 (1972).............................................. 27

Cobbs v. Grant,

8 Cal.3d 229 (1972) .............................................. 27

Cooper v. Roswell Park Comprehensive Cancer

Center, 196 N.Y.S.3d 325 (Sup. Ct. 2023) ........... 12

Cruzan v. Dir., Mo. Dep’t of Health,

497 U.S. 261 (1990) ................................ 7, 9, 10, 27

Doe #1 v. Rumsfeld,

297 F. Supp. 2d 119 (D.D.C. 2003) ...................... 27

Downer v. Veilleux,

322 A.2d 82 (Me. 1974) ........................................ 27

Georgia v. President of the United States,

46 F.4th 1283 (11th Cir. 2022) ............................ 16

Guardianship of Roe,

383 Mass. 415 (1981) ........................................... 28

Health Freedom Defense Fund, Inc. v. Carvalho,

104 F.4th 715 (9th Cir. 2024) ............................. 11

Health Freedom Defense Fund, Inc. v. Carvalho,

148 F.4th 1020 (9th Cir. 2025)

(en banc) .............................................................. 11

–v–

Jacobson v. Massachusetts,

197 U.S. 11 (1905) ................................ 4, 10, 11, 12

Medical Professionals for Informed Consent v.

Bassett, 78 Misc. 3d 482

(Sup. Ct. Jan. 13, 2023)........................................ 16

Miller v. McDonald,

223 L. Ed. 2d 270 (2025) ...................................... 16

Mills v. Rogers,

457 U.S. 291 (1982) .............................................. 28

Nat’l Fed’n of Indep. Bus. v. DOL, OSHA,

595 U.S. 109 (2022) ............................................. 16

Riggins v. Nevada,

504 U.S. 127 (1992) .............................................. 28

Schloendorff v. Society of New York Hospital.

211 N.Y. 125 (1914) .............................................. 27

Sell v. United States,

539 U.S. 166 (2003) .............................................. 28

Texas v. Becerra,

577 F.Supp.3d 527 (N.D. Tex. 2021).................... 16

Texas v. Becerra,

667 F.Supp.3d 252 (N.D.Tex. 2023)..................... 16

Vacco v. Quill,

521 U.S. 793 (1997) ........................................ 27–28

– vi –

Washington v. Harper,

494 U.S. 210 (1990) .............................................. 27

West v. Atkins

487 U.S. 42 (1988) .............................................. 4, 8

STATUTES AND REGULATIONS

18 U.S.C. §241 ........................................................... 28

21 U.S.C. §360bbb-3 ............................ 4, 23, 24, 25, 26

21 C.F.R. Part 50 ....................................................... 26

21 C.F.R. §50.20 .............................................. 4, 23, 26

21 C.F.R. §50.25 ...................................... 4, 7, 8, 23, 26

45 C.F.R. §46.116 ............................................ 4, 23, 26

Iowa House File 712, Bill SF360 .............................. 15

Kentucky House Bill 469 .......................................... 15

Montana House Bill 371 ........................................... 15

Idaho Senate Bill 1036 .............................................. 15

Minnesota HF 3152, HF 3219................................... 15

FEDERAL REGISTER

86 Fed. Reg. 5202 ...................................................... 10

– vii –

FEDERAL RULES

F. R. Civ. P. 12(b)(6) .................................................... 6

OTHER REFERENCES

“33 nurses ‘died suddenly’ in the US this past

week [No causes of death were listed],”

https://markcrispinmiller.substack.com/p/33nurses-died-suddenly-in-the-us ........................... 12

Suzanne Burdick. “Elon Musk reveals COVID

vaccine injury after former Pfizer official

admits shots likely killed tens of thousands

in Germany,” April 13, 2026. https://child

renshealthdefense.org/defender/elon-muskcovid-vaccine-injury-former-pfizer-officialshots-likely-killed-thousands-germany/ .............. 10

Bornali Bhattacharjee, et al. “Immunological

and Antigenic Signatures Associated with

Chronic Illnesses after COVID-19 Vaccination,” medRxiv, February 25, 2025.

https://www.medrxiv.org/content/10.1101/2

025.02.18.25322379v2 .......................................... 19

CDC,

COVID-19

Interim

Operational

Guidance: Jurisdiction Operations, October

29, 2020, Version 2.0. https://www.cdc.

gov/vaccines/imz-managers/downloads/Cov

id-19-Vaccination-Program-Interim_Playbo

ok.pdf .................................................................. 5–6

– viii –

Luigi Cari, et al. “Differences in the expression

levels of SARS-CoV-2 Spike Protein in cells

treated with mRNA-based COVID-19

vaccines: A study on vaccines from the real

world.” Vaccines (Basel) 11(4):879. Apr 21,

2023 https://pubmed.ncbi.nlm.nih.gov/3711

2792 ...................................................................... 25

FDA Biologics License Application Approval

for Comirnaty, August 23, 2021. https://

www.fda.gov/media/151710/download ................ 24

FDA Safety Communication. “FDA Approves

Required Updated Warning in Labeling of

mRNA COVID-19 Vaccines Regarding

Myocarditis and Pericarditis Following

Vaccination. June 25, 2025. https://www.

fda.gov/vaccines-blood-biologics/safety-avail

ability-biologics/fda-approves-required-upda

ted-warning-labeling-mrna-covid-19-vaccines

-regarding-myocarditis-and ................................. 20

“England Refuses to Offer COVID Shots to

Kids Under 12, While US Cities Mandate

Them. Who’s Right?” https://fee.org/articles/

england-refuses-to-offer-covid-shots-to-kidsunder-12-while-us-cities-mandate-them-whos-right ................................................................... 15

“Finland joins Sweden and Denmark in

limiting Moderna COVID-19 vaccine,”

https://www.reuters.com/world/europe/finla

nd-pauses-use-moderna-covid-19-vaccineyoung-men-2021-10-07/ ....................................... 15

– ix –

“Florida State Surgeon General Calls for Halt

in the Use of COVID-19 mRNA Vaccines.”

https://www.floridahealthgov/newsroom/20

24/01/20240103-halt-use-covid19-mrna-vac

cines.pr.html ......................................................... 14

Simone Gold, M.D., J.D. “A White Paper on

Hydroxychloroquine,” https://americasfront

linedoctors.org/index/covid/hydroxychloroq

uine/white-paper/ ................................................. 22

Josh Guetzkow and Retsef Levi. “Effect of

mRNA vaccine manufacturing processes on

efficacy and safety still an open question”

(letter to the Editor), BMJ 2022;378:o1731.

July 12, 2022. https://www.bmj.com/

content/378/bmj.o1731/rr-2 .................................. 25

Lee Harding. “Japanese researchers say side

effects of COVID vaccines linked to 201

types of diseases,” Western Standard,

January 15, 2024. https://www.western

standard.news/news/japanese-researcherssay-side-effects-of-covid-vaccines-linked-to201-types-of-diseases/51661................................. 18

Jesús Hermosilla, et al. “Analysing the in-use

stability of mRNA-LNP COVID-19 vaccines

Comirnaty™ (Pfizer) and Spikevax™

(Moderna): A comparative study of the

particulate.” Vaccines (Basel) 11(11):1635.

Oct 25, 2023. https://pubmed.ncbi.nlm.nih.

gov/38005967 ........................................................ 25

–x–

https://aflds.org/about-us/press-releases/ameri

cas-frontline-doctors-supports-the-filing-ofa-petition-for-preliminary-injunction-to-pre

vent-kaiser-permanente-from-enforcing-th

eir-vaccine-mandate ............................................... 3

https://c19hcq.org/ ..................................................... 22

https://www.hhs.gov/ohrp/regulations-and-pol

icy/regulations/common-rule/index. html ........... 23

https://c19ivm.org/ ..................................................... 22

https://openvaers.com/covid-data.......................... 9, 17

https://x.com/drsimonegold/status/1892626222

250639592 ............................................................ 19

https://x.com/SecKennedy/status/19273684408

11008138 .............................................................. 13

Hong Jin Kim, et al. “Broad-Spectrum Adverse

Events of Special Interests Based on

Immune Response Following COVID-19

Vaccination: A Large-Scale PopulationBased Cohort Study,” J. Clin. Med. 14(5)

1767, March 6, 2025. https://www.mdpi.

com/2077-0383/14/5/1767 ..................................... 21

Tomomi Koizumi and Masao Ono, “Cardiac

Multiple Micro-Scars: An Autopsy Study,”

J Am Coll Cardiol Case Rep. 30(5) 10383,

March 2025. https://www.jacc.org/doi/10.

1016/j.jaccas.2024.103083.................................... 19

– xi –

Raphael Lataster, Ph.D. “European excess

mortality correlates with COVID-19

vaccination into 2024.” Bulgarian Medicine

13:2 (2023). https://www.skirsch.com/covid/

lataster.pdf ........................................................... 14

Ross Lazarus, et al., “Electronic Support for

Public Health—Vaccine Adverse Event

Reporting System,” AHRQ Grant Final

Report, 2011. https://digital.ahrq.gov/sites/

default/files/docs/publication /r18hs017045lazarus-final-report-2011.pdf......................... 17–18

Retsef Levi, et al. “Twelve-month all-cause

mortality after initial COVID-19 vaccination with Pfizer-BioNTech or mRNA-1273

among

adults

living

in

Florida,”

https://doi.org/10.1101/2025.04.25.25326460 ....... 13

“Louisiana health officials ‘shifting away’ from

policy of promoting COVID, flu vaccinetions.” https://www.nola.com/news/politics/

vaccine-louisiana-policy-covid-flu/article_3e

0521bc-c096-11ef-bfd3-fb389831770e.html ......... 14

Vibeke Manniche, et al. “Batch-Dependent

Safety Signal: Nationwide Analysis of

Suspected Adverse Events Following

COVID-19 Vaccination in Germany,”

March 10, 2026. https://www.preprints.

org/manuscript/202603.0688 ............................... 20

– xii –

Vibeke Manniche, et al. “Rates of successful

conceptions

according

to

COVID-19

vaccination status: Data from the Czech

Republic.” https://www.preprints.org/manu

script/202504.2487/v1?utm_source=substac

k&utm_medium=email ........................................ 13

M. Nathaniel Mead, et al. “Myocarditis after

SARS-CoV-2 infection and COVID-19

vaccination: Epidemiology, outcomes, and

new perspectives,” Intl J Cardiovascular

Rsch & Innovation, 3(1) 1-43, Jan-Mar

2025. https://cardiovascular-research-andinnovation.reseaprojournals.com/Articles/

myocarditis-after-sars-cov-2-infection-andcovid-19-vaccination-epidemiologyoutcomes-and-new-perspectives) ......................... 19

Art Moore. “CDC data signaling vaccine

catastrope: It took only 32 deaths to halt

1976 shot campaign.” World Net Daily,

February 14, 2022. https://www.wnd.com/

2022/02/cdc-data-signaling-vaccinecatastrophe/ .......................................................... 18

Michael Nevradakis, Ph.D. “Slovak Government Report Calls for Ban of ‘Dangerous’

mRNA Vaccines,” Science, Public Health

Policy and the Law. https://publichealth

policyjournal.com/slovak-governmentreport-calls-for-ban-of-dangerous-mrnavaccines/ ......................................................... 15–16

– xiii –

“New risks raise pandemic threat on a global

scale,”

https://www.gpmb.org/news/news/

item/14-10-2024-new-risks-raise-pandemicthreat-on-a-global-scale ....................................... 16

Elizabeth Nix. “Tuskegee Experiment: The

Infamous Syphilis Study,” History, May 16,

2017.

https://www.history.com/news/theinfamous-40-year-tuskegee-study ................. 28–29

E.O. Okoro, et al. “Paradoxical increase in

global COVID-19 deaths with vaccination

coverage: World Health Organization

estimates

(2020–2023).”

International

Journal of Risk & Safety in Medicine.

2025;0(0). https://journals.sagepub.com/doi/

10.1177/ 09246479251336610 ........................ 13–14

André Redert, Ph.D. “Causal effect of covid

vaccination on mortality in Europe.”

February 2023. https://www.researchgate.

net/publication/368777703_Causal_effect_o

f_covid_vaccination_on_mortality_in_Europe ....... 14

Harold M. Schmeck, Jr. “Swine flu program is

halted in 9 states as 3 die after shots,” The

New York Times, October 13, 1976.

https://www.nytimes.com/1976/10/13/archiv

es/swine-flu-program-is-halted-in-9-statesas-3-die-after-shots.html ...................................... 18

– xiv –

Keisuke Takada, et al. “SARS-CoV-2 mRNA

vaccine-related myocarditis and pericarditis: An analysis of the Japanese Adverse

Drug Event Report database,” J Infect

Chemother., January 2025, 31(1):102485.

https://pubmed.ncbi.nlm.nih.gov/39103148/ ....... 19

James A. Thorp, et al. “Are COVID-19

Vaccines in Pregnancy as Safe and

Effective as the Medical Industrial

Complex Claim? Part I,” Science, Public

Health Policy and the Law, 2/08/2025.

https://publichealthpolicyjournal.com/arecovid-19-vaccines-in-pregnancy-as-safeand-effective-as-the-medical-industrialcomplex-claim-part-i/ ........................................... 20

Trials of War Criminals Before the Nuernberg

Military Tribunals Under Control Council

Law No. 10, Volume II (U.S. Government

Printing Office 1949). https://www.guten

berg.org/ebooks/54905 ......................................... 27

“TRUTH BOMB: Peter McCullough Doesn’t

Hold Back — ‘IT WAS NOT SAFE BY

DESIGN,’” https://x.com/ChildrensHD/status

/1925355939369988144........................................ 13

Lizhou Zhang, et al. “Effect of mRNA-LNP

components of two globally-marketed

COVID-19 vaccines on efficacy and

stability.” NPJ Vaccines 8(1):156 (2023).

https://pubmed.ncbi.nlm.nih.gov/ 37821446/ ...... 25

–1–

A MATTER OF GREAT PUBLIC IMPORTANCE

Coercively mandating dangerous and possibly

fatal experimental drugs by overriding informed

consent cannot be countenanced. This is about saving

lives.

The Free Speech Foundation, d/b/a America’s

Frontline Doctors and Dr. Simone Gold, M.D., J.D.,

the founder and physician member (“AFLDS”),

respectfully file this amici curiae brief in support of

the Petitioners for reversal in Boyd, et al. v Shriners

Hospital for Children, et al., 26-220.1

Amici Curiae have filed amici briefs in recent

cases affecting public health and medical freedom

such as Chiles v. Salazar, No. 24-539, Does 1-2 v.

Hochul, No. 24-1015; Stockton v. Brown, No. 25-606;

Mirabelli v. Bonta, No. 25A810; and Heath v.

EcoHealth Alliance, Inc., No. 25-740.

AFLDS also filed briefs in cases recently decided

by this Honorable Court, such as Miller v. McDonald,

No. 25-133; United States v. Skrmetti, No. 23-477;

and Mahmoud v. Taylor, No. 24-297 (2024).

This amici curiae brief offers an important

medical and legal perspective to this Court on a

matter of great public importance, by demonstrating

that Respondents engaged in unconstitutional

activity by “mandating” dangerous experimental

medical treatments in violation of informed consent,

No counsel or any party authored or prepared this brief in

whole or in part, or made a monetary contribution intended to

fund its preparation or submission. The Boyd parties received

timely notice of this brief’s filing.

1

–2–

their own agreements, and the numerous clearly

established laws and regulations enumerated herein.

These unconstitutional, illegal, irrational and

medically dangerous coercive mandates should be

rejected.

INTEREST OF AMICI CURIAE

Amici Curiae are the Free Speech Foundation,

d/b/a America’s Frontline Doctors (“Amici Curiae” or

“AFLDS”), a non-partisan, not-for-profit organization

of thousands of member physicians from across the

country, representing a range of medical disciplines

and practical experience on the front lines of

medicine, and its founder and expert physician with

over twenty years’ experience as an emergency room

physician in minority communities, Dr. Simone Gold,

M.D., J.D.2

AFLDS’

including:

programs

focus

• Providing Americans

facts about COVID-19;

on

with

critical

issues,

science-based

• Combating COVID-19 with evidence-based

approaches without compromising constitutional freedoms;

• Advancing healthcare policies that protect

the physician-patient relationship;

• Expanding COVID-19 treatment options for

all Americans who need them; and

2 https://americasfrontlinedoctors.org/about-us.

–3–

• Strengthening the voices of frontline doctors

in the national healthcare conversation.

Dr. Gold and AFLDS publicly supported the

position, as early as October, 2020, that experimental

mRNA injections are not “vaccines,” because they do

not prevent infection or transmission, and they are

neither “safe” nor “effective.”3 This view is now

known to be scientifically and legally correct.

“Informed consent” cannot truly be informed

unless there is a full disclosure of all known benefits

and risks. Voluntary informed consent can never be

coerced, subjected to undue influence, nor distorted

by censored and incomplete information, especially

regarding experimental or investigational drugs.

SUMMARY OF ARGUMENT

The CDC’s operational guidance for the

nationwide COVID-19 vaccine distribution program

relied upon a web of binding agreements among

federal, state, and local governments and frontline

providers to ensure that the COVID-19 vaccination

program was implemented in adherence with all

federal guidance, requirements and constraints. All

actors involved in the federal distribution program

were contractually and legally bound to comply with

federal

constitutional

and

statutory

rights,

obligations, and rules concerning investigational

https://aflds.org/about-us/press-releases/americas-frontline-doc

tors-supports-the-filing-of-a-petition-for-preliminary-injunction-toprevent-kaiser-permanente-from-enforcing-their-vaccine-mandate

3

–4–

drugs. See, e.g., West v. Atkins, 487 U.S. 42, 48-57

(1988).

The mRNA injections introduced to treat COVID19 are now scientifically demonstrated to be neither

safe nor effective, but rather disabling and causative

of death at high rates. This is now widely understood,

and the federal and state governments are responding to these facts by changing policy. This was not

at issue when Jacobson v. Massachusetts, 197 U.S.

11 (1905) was decided, and vaccine efficacy and

safety was assumed.

At the time of Respondents’ “mandates,” the

mRNA injections were indisputably investigational.

Thus, the informed consent regulations governing

experimental, investigational drugs, including 21

U.S.C. §360bbb-3, 21 C.F.R. §50.20, 21 C.F.R. §50.25,

and 45 C.F.R. §46.116, were binding upon both public

and private actors.

To “mandate” an experimental and personal

medical treatment which does not prevent infection

or transmission, and which also has severe

undisclosed side effects including death, under the

coercive threat of loss of employment, violates wellestablished constitutional provisions, numerous civil

and criminal laws and regulations, and is irrational

and against public policy.

Further, Respondents contractually agreed to act

with all federal (and crucially important) informed

consent and constitutional responsibilities and

obligations as a condition of participation in the

CDC’s COVID-19 Vaccination Program.

Discovery has not yet begun in this case.

Petitioners’ fundamental rights violation claims

–5–

should not be prematurely dismissed. At this

juncture, any doubt should be resolved in favor of

voluntary patient freedom of choice, and against

coercing unwanted and dangerous experimental

medical treatments upon anyone. This is good public

policy.

The petitions for writs of certiorari should be

granted.

ARGUMENT

I.

The CDC’s operational guidance for

nationwide COVID-19 vaccine distribution relied upon a web of binding

agreements among federal, state, and

local

governments

and

frontline

providers to ensure that the COVID-19

vaccination program was implemented

in adherence with all federal guidance,

requirements and constraints. All

actors

involved

in

the

federal

distribution program were contractually and legally bound to comply

with

federal

constitutional

and

statutory rights, obligations, and rules

concerning experimental, investigational drugs.

Respondents violated

binding

informed

consent

and

experimental drug regulations.

The CDC’s COVID-19 Interim Operational

Guidance: Jurisdiction Operations established a web

of contracts and cooperative agreements among

federal, state, local officials and providers, with the

–6–

stated goal of closely monitoring vaccination

activities at the local level to ensure that the COVID19

Vaccination

Program

(“Program”)

was

implemented throughout local jurisdictions “in

adherence with federal guidance and requirements.”4

This contractually imposed affirmative obligations

upon states and state providers to comply with all

federal guidance, constitutional and statutory

provisions, rules and requirements, including all

informed consent provisions, as a condition for

participation in the Program. This broad area of

inquiry must be subject to discovery, and is

inappropriate for a premature Rule 12(b)(6)

dismissal, especially considering the public

importance of these issues. Unwitting and unwilling

medical experimentation upon humans is abhorrent

and cannot be upheld under any rationale.

The federal government entered agreements with

each state’s public health officials to distribute the

COVID-19 vaccines through state healthcare

providers. Enrolled state providers such as Shriners

Hospitals for Children were obligated as state and

federal actors to follow all federal rules as outlined

above, and Respondent providers were obligated

directly via the Federalwide Assurance agreement to

comply.5

All participants in the Program, including

Respondent Shriners, contractually agreed to all

See COVID-19 Interim Operational Guidance: Jurisdiction

Operations, October 29, 2020, Version 2.0, Section 2: COVID-19

Organizational Structure and Partner Involvement, p. 8.

https://www.cdc.gov/vaccines/imz-managers/downloads/Covid19-Vaccination-Program-Interim_Playbook.pdf

5 As described by Petitioners in their petition.

4

–7–

federal rights, obligations, and rules including the

necessity of informed consent, free from coercion, and

were required to follow all informed consent rules

and constitutional provisions such as the personal

right to refuse medical treatments under Cruzan v.

Dir., Mo. Dep’t of Health, 497 U.S. 261 (1990). This

included all statutes and rules governing

experimental drugs binding upon both public and

private

actors.

And

the

Pfizer/BioNTech

experimental drug was never approved by the F.D.A.,

contrary to the erroneous findings of the Third

Circuit.

As an example, 21 C.F.R. § 50.25(a)(8) provides

that persons administered experimental, investigational drugs be furnished with:

(8) A statement that participation is

voluntary, that refusal to participate will

involve no penalty or loss of benefits to which

the subject is otherwise entitled, and that

the subject may discontinue participation at

any time without penalty or loss of benefits

to which the subject is otherwise entitled.

A Program participant employer “mandate” that

coerces employees to take experimental drugs clearly

violates these provisions. The Third Circuit ignored

Respondent Shriners’ contractual agreements to

follow all constitutional and statutory provisions

binding on the state government and themselves as

investigational drug providers, by erroneously

finding that Comirnaty, an approved vaccine, was

“the functional equivalent” of the Pfizer/BioNTech

–8–

COVID-19

experimental

mRNA

injection.6

Comirnaty was not being distributed through the

CDC program, however; Shriners’ mandated the

experimental injection only, the only drug it agreed

to distribute under the CDC program.

All actors involved in the federal distribution

program were contractually and legally bound to

comply with federal constitutional and statutory

rights,

obligations,

and

rules

concerning

investigational drugs. See, e.g., West v. Atkins, 487

U.S. 42, 48-57 (1988) (doctor under contract to

provide medical services to inmates at a state prison

hospital acts “under color of state law,” within the

meaning of § 1983).

The Third Circuit erroneously created a

distinction between “Shriners internal vaccine

mandate” and Shriners’ participation in the “state’s

public vaccination program,” ignoring the operation

of the contractual and legal obligations which

Shriners entered into upon participation as a state

provider of the emergency vaccines under the CDC

program.7 Thus, the Third Circuit concluded that

Shriners had authority to coerce its employees into

receiving an investigational drug without regard to

its state and federal agreements regarding the

voluntary, informed consent nature of such drugs.

There is no authority, under state or federal law, to

“mandate” any person to inject a drug under

investigational status; no American can be coerced to

participate in a medical experiment. See, e.g., 21

C.F.R. § 50.25, supra.

6 See Boyd Appendix, App. 3a, n.1.

7 See Boyd Appendix, App. 7a.

–9–

II. Cruzan v. Dir., Mo. Dep’t of Health

requires personal medical treatment

decisions to be strictly voluntary and

free from coercion or pressure. The

courts below erred in allowing

Respondents to evade their state and

federal contractual responsibilities to

follow applicable federal constitutional

and statutory provisions as Program

participants or as private parties by

coercively “mandating” a dangerous

experimental treatment which does not

prevent infection or transmission, and

which has severe undisclosed side

effects, including death.

To “mandate” an experimental and personal

medical treatment which does not prevent infection

to oneself, or transmission to other people, and which

also has severe undisclosed side effects including

death, under the coercive threat of loss of

employment, violates well-established constitutional

provisions and numerous civil and criminal laws and

regulations

It is now becoming widely known that the

experimental mRNA injections introduced to treat

COVID-19 are neither “safe,” on account of their

terrible safety profiles, nor “effective,” because they

do not stop transmission of the virus or protect other

people. Further, these “mandated” drugs are

dangerous. They can and do kill people.8 These

experimental, investigational drugs offer no

8 See https://openvaers.com/covid-data.

– 10 –

protection for other people.9 They are personal

medical treatments only.

Dr. Helmut Sterz, Pfizer’s former chief

toxicologist, admitted early in 2026, during a

German COVID-19 inquiry, that an estimated 60,000

people died in Germany from Pfizer’s COVID-19

vaccine Comirnaty. An estimated 25 severe side

effects from the vaccine occurred for every one severe

course of infection the shots allegedly prevented.10

The mRNA injections introduced to treat

COVID-19 are now scientifically demonstrated to be

neither safe nor effective, but rather disabling and

causative of death at high rates. This is now widely

understood. By contrast, when Jacobson v.

Massachusetts, 197 U.S. 11 (1905) was decided —

well before Cruzan v. Dir., Mo. Dep’t of Health, 497

U.S. 261 (1990) — the safety and efficacy of the

smallpox vaccine then in use was assumed. The

circuit courts have failed to recognize that Jacobson

was decided well before Congress passed the FDCA

in exercise of its commerce power and required

approval of drugs introduced or delivered into

interstate commerce, as well as the consent of

subjects given experimental drugs. A fundamental

question, never addressed in Jacobson, and still not

addressed, is whether state or private actors can

9 See the December 11, 2020 EUA letter to Pfizer stating that

the Pfizer-BioNTech COVID-19 Vaccine is an “investigational

vaccine not licensed for any indication.” 86 Fed. Reg. 5202

(January 19, 2021).

10 Burdick, Suzanne. “Elon Musk reveals COVID vaccine injury

after former Pfizer official admits shots likely killed tens of

thousands in Germany,” April 13, 2026. https://childrens

healthdefense.org/defender/elon-musk-covid-vaccine-injury-form

er-pfizer-official-shots-likely-killed-thousands-germany/

– 11 –

mandate drugs which are not legally approved for

commerce under federal law.

The original three-judge panel opinion of the

Ninth Circuit in Health Freedom Defense Fund, Inc.

v. Carvalho, 104 F.4th 715 (9th Cir. 2024) correctly

distinguished Jacobson:

Jacobson, however, did not involve a claim

in which the compelled vaccine was

“designed to reduce symptoms in the infected

vaccine recipient rather than to prevent

transmission and infection.” The district

court thus erred in holding that Jacobson

extends beyond its public health rationale—

government’s power to mandate prophylactic

measures aimed at preventing the recipient

from spreading disease to others—to also

govern “forced medical treatment” for the

recipient’s benefit.

Id., at 725 (some internal citations omitted).

The three-judge panel recognized that forcibly

mandated personal medical treatments upon

employee/patients could not be justified by the

“protection of the public” rationale of Jacobson, when

the mRNA injections did not stop infection or

transmission or afford protection for others.

Unfortunately, this correct and significant panel

decision was overturned by the en banc Ninth Circuit

in Health Freedom Defense Fund, Inc. v. Carvalho,

148 F.4th 1020 (9th Cir. 2025), an error now final

after a denial of certiorari, and an error other circuit

courts have been emboldened to repeat.

– 12 –

Many states recognize that this is an important

issue. The Attorneys General of twelve states filed an

excellent amici curiae brief in Carvalho, No. 25-765,

precisely analyzing why Jacobson is distinguishable

from the COVID-19 “mandates” of experimental

vaccines, and calling for the reaffirmation of the

fundamental right to be free from compelled medical

treatments.11

Mandating

unwanted

and

dangerous

investigational drugs is irrational, pointless, and

against good public policy. See, e.g., Cooper v.

Roswell Park Comprehensive Cancer Center, 196

N.Y.S.3d 325, (Sup. Ct., Aug. 17, 2023), finding that

the decision to terminate a nurse because of her

refusal to take a COVID-19 injection was

“irrational.”12

III. Respondents’ illegal mandates under

coercive threat of loss of employment

violates

informed

consent,

wellestablished constitutional provisions,

and numerous civil and criminal laws

and regulations. Governments are

increasingly recognizing such mandates as irrational and against public

policy.

See Brief for the States of Texas, et al., in Support of

Petitioners,

https://www.supremecourt.gov/DocketPDF/25/25765/395027/20260129162315271_25-765_Amici%20Brief.pdf

12 As in Petitioners’ case here, medical personnel were

especially targeted with “mandated” COVID-19 injections, and

sudden adult deaths have risen in this group. See, e.g., “33

nurses ‘died suddenly’ in the US this past week [No causes of

death were listed],” https://markcrispinmiller.substack.com/

p/33-nurses-died-suddenly-in-the-us

11

– 13 –

In response to the true facts of lack of safety and

efficacy, government policies and recommendations

have changed.

HHS Secretary Kennedy announced on May 27,

2025 that the COVID vaccine for healthy children

and healthy pregnant women was removed from the

CDC’s

recommended

immunization

schedule,

13

changing previous CDC recommendations.

In dynamic testimony before Congress on May

21, 2025, followed by rousing applause, renowned

expert cardiologist Dr. Peter A. McCullough, M.D.

explained exactly why the experimental mRNA

injections were neither safe nor effective, and were

dangerous.14

Many more recent and reliable medical studies

further explode the “safe and effective” narrative.15

13 https://x.com/SecKennedy/status/1927368440811008138

14 “TRUTH BOMB: Peter McCullough Doesn’t Hold Back — ‘IT

WAS NOT SAFE BY DESIGN,’” https://x.com/ChildrensHD/

status/1925355939369988144

15 Five recent papers show vaccine COVID vaccine harms

outweigh any benefits:

The Pfizer injection increases all cause mortality by greater

than 36%. Retsef Levi, et al. “Twelve-month all-cause mortality

after initial COVID-19 vaccination with Pfizer-BioNTech or

mRNA-1273 among adults living in Florida,” https://

doi.org/10.1101/2025.04.25. 25326460

Women who got the shot were 30–50 percent less likely to

give birth, see Vibeke Manniche, et al. “Rates of successful

conceptions according to COVID-19 vaccination status: Data

from the Czech Republic.” https://www.preprints.org/manu

script/202504.2487/v1?utm_source=substack&utm_medium=em

ail

One paper shows a high correlation between vaccination and

death. E.O. Okoro, et al. “Paradoxical increase in global COVID-

– 14 –

Florida state Surgeon General Dr. Joseph A.

Ladapo called for a complete halt in the use of

COVID-19 mRNA “vaccines,” citing contamination

concerns.16

Louisiana health officials shifted away from

promoting COVID-19 and flu vaccinations.17 The

Louisiana Health Department stated that medicine

is not “one size fits all.” All patients are different,

with different medical needs. Therefore, it is

inappropriate and possibly medical malpractice to

issue blanket medical treatment recommendations or

19 deaths with vaccination coverage: World Health

Organization estimates (2020–2023).” International Journal of

Risk & Safety in Medicine. 2025;0(0). https://journals.sagepub.

com/doi/10.1177/ 09246479251336610

There is a strong correlation between vaccine uptake and

excess all-cause mortality. See Raphael Lataster, Ph.D.

“European excess mortality correlates with COVID-19

vaccination into 2024.” Bulgarian Medicine 13:2 (2023).

https://www.skirsch.com/covid/lataster.pdf

A vaccine dose fatality rate of 0.35% in Europe is greater

than the infection fatality rate of 0.1% for COVID. See André

Redert, Ph.D. “Causal effect of covid vaccination on mortality in

Europe.”

February

2023.

https://www.researchgate.net/

publication/368777703_Causal_effect_of_covid_vaccination_on_

mortality_in_Europe

16 “Florida State Surgeon General Calls for Halt in the Use of

COVID-19 mRNA Vaccines.” https://www.floridahealthgov/

newsroom/2024/01/20240103-halt-use-covid19-mrna-vaccines.pr.

html

17 Louisiana Department of Health statement: “In general, the

department is shifting away from one-size-fits-all paternalistic

guidance to a more informative approach aimed at enabling

individuals, in consultation with their doctor, to make better

decisions for themselves.” “Louisiana health officials ‘shifting

away’ from policy of promoting COVID, flu vaccinations.”

https://www.nola.com/news/politics/vaccine-louisiana-policycovid-flu/article_3e0521bc-c096-11ef-bfd3-fb389

– 15 –

requirements to broad categories of patients, without

first assessing and examining each patient

individually, and without diagnosing their unique

medical conditions by a qualified medical

professional.

A wave of bills introduced in state legislatures

recently, including Iowa, Kentucky, Montana,

Minnesota, Idaho and others, seek to limit or ban

entirely the administration of these experimental

mRNA injections, or gene therapy, due to the terrible

safety profiles of these experimental drugs.18

If these investigational drugs were truly safe,

why are many states seeking to ban them?

Many European countries, including Finland,

Sweden, Denmark, the United Kingdom and

Slovakia have taken similar actions in limiting or

eliminating their previous blanket mRNA injection

recommendations.19,20

18 See, e.g., Iowa House File 712, Bill SF360; Kentucky House

Bill 469; Montana House Bill 371; Idaho Senate Bill 1036;

Minnesota HF 3152, HF 3219.

19 “Finland joins Sweden and Denmark in limiting Moderna

COVID-19 vaccine,” https://www.reuters.com/world/europe/

finland-pauses-use-moderna-covid-19-vaccine-young-men-202110-07/

“England Refuses to Offer COVID Shots to Kids Under 12,

While US Cities Mandate Them. Who’s Right?”: “... the

UKHSA’s decision puts England in line with other European

countries—including

Sweden,

Finland,

Norway,

and

Denmark—that do not offer or recommend mRNA vaccines to

healthy young children.” https://fee.org/articles/england-refusesto-offer-covid-shots-to-kids-under-12-while-us-cities-mandatethem-who-s-right/

20 Michael Nevradakis, Ph.D. “Slovak Government Report Calls

for Ban of ‘Dangerous’ mRNA Vaccines,” Science, Public Health

Policy and the Law. https://publichealthpolicyjournal.com/

– 16 –

The ruling below failed to follow the lead of Nat’l

Fed’n of Indep. Bus. v. DOL, OSHA, 595 U.S. 109

(2022), in which this Court stayed the OSHA

nationwide employee vaccine mandate, and Georgia

v. President of the United States, 46 F.4th 1283 (11th

Cir. 2022), which upheld the nationwide injunction

pausing the federal contractor vaccine mandate. See

also Texas v. Becerra, 577 F.Supp.3d 527 (N.D.Tex.

2021) and 667 F.Supp.3d 252 (N.D.Tex. 2023) (HHS

lacked authority to mandate any specific type of

medical treatments, specifically a vaccine for Head

Start staff, contractors and volunteers; court vacated

the federal rule entirely.); Miller v. McDonald, 223 L.

Ed. 2d 270 (2025) (school vaccine mandate rejected).

In Medical Professionals for Informed Consent v.

Bassett, 78 Misc. 3d 482 (Sup. Ct. Jan. 13, 2023), the

court granted a declaratory judgment to a group of

doctors and nurses, holding that the hospital and

“covered entities” vaccine mandate ordered by the

New York State Department of Health (DOH) was

null, void, and of no effect. The mandate was then

dropped by DOH, so any appeal was deemed moot.21

These vaccine mandate cases are flooding the

lower courts. These medical freedom public policy

issues should be urgently addressed by this Court,

especially since lives are at stake.

slovak-government-report-calls-for-ban-of-dangerous-mrnavaccines/

21 These issues are extremely likely to recur, yet are evading

review. While new pandemics threaten, numerous antimandate cases have also flooded American courts. Illegal

mandates may continuously recur if not corrected now. See

“New risks raise pandemic threat on a global scale,”

https://www.gpmb.org/news/news/item/14-10-2024-new-risksraise-pandemic-threat-on-a-global-scale

– 17 –

In all good conscience, how can anyone coercively

“mandate” any drug that might kill a patient,

without voluntary, coercion-free consent, and without

being fully informed of the risks?

IV. It is undisputed that the mandated

experimental, investigational mRNA

injectable drugs have shockingly high

fatality

rates.

The

CDC’s

own

reporting system has documented

millions of adverse reactions, disabilities and hospitalizations and a

tragic 39,205 fatalities attributable to

these mRNA injections through July

31, 2026. Previously, a vaccine would

be pulled from the market after only a

few deaths. A medical mandate to take

an experimental injection is against

public policy.

The CDC’s Vaccine Adverse Event Reporting

System (VAERS) data show that as of July 31, 2026,

there have been 39,205 deaths in America alone,

which thousands of medical professionals have

independently attributed to fatal adverse reactions to

the mandated experimental mRNA injections, a.k.a.

“vaccines.”22 This cannot remotely be considered

“safe” or “effective.” Additionally, VAERS recorded

74,902 permanently disabled persons, 5,223

miscarriages, 22,560 heart attacks, and 29,264

Myocarditis/Pericarditis cases.23

22 https://openvaers.com/covid-data

23 These figures are even more astonishing when it is considered

that they likely represent less than 1% of the true adverse

events and fatalities attributable to COVID-19 injections. In

– 18 –

Thus the American reported death toll has now

risen to an astonishing 39,205 deaths.

High adverse reaction statistics obviously form a

reasonable basis for some patients to avoid risky

investigational mRNA injections in favor of safer

alternatives, in the exercise of voluntary consent,

free of coercion, and after the required full disclosure

of these medical risks.

In stark contrast to recent experience, in 1976,

after only 32 deaths were attributable to the swine

flu vaccine, the United States government halted its

mass vaccination campaign.24 The campaign was

halted in nine states after only three deaths were

attributed to the vaccine shots.25

Japanese researchers linked these experimental

mRNA injection side effects to 201 types of

diseases.26 In another Japanese study, researchers

found on autopsy multiple micro-scars in the hearts

of mRNA-vaccinated patients who died suddenly of

2011, an investigation of VAERS by Harvard Pilgrim Health

Care Inc. reported: “Adverse events … are common, but … fewer

than 1% of vaccine adverse events are reported [to the FDA].”

https://digital.ahrq.gov/sites/default/files/docs/publication/r18hs017

045-lazarus-final-report-2011.pdf

24 Art Moore. “CDC data signaling vaccine catastrope: It took

only 32 deaths to halt 1976 shot campaign.” World Net Daily,

February 14, 2022. https://www.wnd.com/2022/02/cdc-data-sig

naling- vaccine-catastrophe/

25 Harold M. Schmeck, Jr. “Swine flu program is halted in 9

states as 3 die after shots,” The New York Times, October 13,

1976.

26 Lee Harding. “Japanese researchers say side effects of COVID

vaccines linked to 201 types of diseases,” Western Standard,

January 15, 2024. https://www.westernstandard.news/news/jap

anese-researchers-say-side-effects-of-covid-vaccines-linked-to-201types-of-diseases/51661

– 19 –

unexplained cardiac arrest, thus raising the question

of a link between the experimental mRNA injections

and sudden cardiac arrest.27 And in yet another

recent Japanese study, SARS-CoV-2 mRNA

vaccination was significantly associated with the

onset of myocarditis/pericarditis in the Japanese.

The influencing factors included being less than 30

years old, and male.28

Further, an alarming Yale study showed that

COVID vaccines may cause T-cell exhaustion,

leading to an acquired immune deficiency. Could this

be “...a vaccine that weakens immunity instead of

strengthening it?”29

An authoritative study examining the link

between the COVID-19 vaccine and Myocarditis was

just published this year. The study’s conclusion: “We

urge governments to remove the COVID-19 mRNA

products from the market due to the well-documented

risk of myocardial damage.”30

27 Tomomi Koizumi and Masao Ono. “Cardiac Multiple MicroScars: An Autopsy Study,” J Am Coll Cardiol Case Rep. 30(5)

10383, March 2025. https://www.jacc.org/doi/10.1016/j.jaccas.

2024.103083

28 Keisuke Takada, et al. “SARS-CoV-2 mRNA vaccine-related

myocarditis and pericarditis: An analysis of the Japanese

Adverse Drug Event Report database,” J Infect Chemother.,

January 2025, 31(1):102485. https://pubmed.ncbi.nlm.nih.gov/

39103148

29 https://x.com/drsimonegold/status/1892626222250639592; see

also Bornali Bhattacharjee, et al. “Immunological and Antigenic

Signatures Associated with Chronic Illnesses after COVID-19

Vaccination,” medRxiv, February 25, 2025. https://www.

medrxiv.org/content/10.1101/2025.02.18.25322379v2

30 M. Nathaniel Mead, et al. “Myocarditis after SARS-CoV-2

infection and COVID-19 vaccination: Epidemiology, outcomes,

and new perspectives,” Intl J Cardiovascular Rsch &

– 20 –

Accordingly, in June 2025 the FDA found it

necessary to approve an updated, stricter warning

label for mRNA COVID-19 vaccines, regarding the

risks of myocarditis and pericarditis following

COVID-19 vaccination.31

A brand-new German study shows mRNA

“vaccines” were not safe when first rolled out, and

that adverse events were batch-dependent; with

some batches worse than others.32

Another recent study highlighted that Pfizer’s

post-marketing surveillance analysis showed a

miscarriage rate of 81%, a 5-fold increase in

stillbirths, an 8-fold increase in neonatal deaths, and

a 13% incidence of breastfeeding complications in

newborns whose mothers received the COVID

shots:33

Innovation, 3(1) 1–43, Jan–Mar 2025. https://cardiovascularresearch-and-innovation.reseaprojournals.com/Articles/myocard

itis-after-sars-cov-2-infection-and-covid-19-vaccination-epidemio

logy-outcomes-and-new-perspectives)(emphasis added)

31 “FDA Approves Required Updated Warning in Labeling of

mRNA COVID-19 Vaccines Regarding Myocarditis and

Pericarditis Following Vaccination. June 25, 2025. https://www.

fda.gov/vaccines-blood-biologics/safety-availability-biologics/fdaapproves-required-updated-warning-labeling-mrna-covid-19-vac

cines-regarding-myocarditis-and

32 Vibeke Manniche, et al. “Batch-Dependent Safety Signal:

Nationwide Analysis of Suspected Adverse Events Following

COVID-19 Vaccination in Germany,” March 10, 2026.

https://www.preprints.org/manuscript/202603.0688

33 James A. Thorp, et al. “Are COVID-19 Vaccines in Pregnancy

as Safe and Effective as the Medical Industrial Complex Claim?

Part I,” Science, Public Health Policy and the Law, 2/08/2025.

https://publichealthpolicyjournal.com/are-covid-19-vaccines-inpregnancy-as-safe-and-effective-as-the-medical-industrial-com

plex-claim-part-i/

– 21 –

Results: The CDC/FDA’s safety signals were

breached for all 37 AEs following COVID-19

vaccination in pregnancy including miscarriage, chromosomal abnormalities, fetal

malformations, cervical insufficiency, fetal

arrhythmia, hemorrhage in pregnancy,

premature

labor/delivery,

preeclampsia,

preterm rupture of membranes, placental

abnormalities, fetal growth restriction,

stillbirth, newborn asphyxia and newborn

death. Conclusions: We found unacceptably

high breaches in safety signals for 37 AEs

after COVID-19 vaccination in pregnant

women. An immediate global moratorium on

COVID-19 vaccination during pregnancy is

warranted. (emphasis added)

Further, a massive study released in March,

2025 found that among 1.7 million people, COVID-19

vaccination increased the risk of “Inner Ear

Disorders by 237%, Menstrual Disorders by 216%,

Glaucoma by 186%, and Endometriosis by 150%,

along with many other negative side effects.”34

It is dangerous to fail to disclose to patients, as

required, this truthful and accurate medical

information in any ill-conceived and coercively

mandatory

vaccination

campaign.

It

is

unconscionable to attempt to mandate a dangerous

experimental drug which does not protect other

people.

34 Hong Jin Kim, et al. “Broad-Spectrum Adverse Events of

Special Interests Based on Immune Response Following

COVID-19 Vaccination: A Large-Scale Population-Based Cohort

Study,” J. Clin. Med. 14(5) 1767, March 6, 2025. https://

www.mdpi.com/2077-0383/14/5/1767

– 22 –

Amici Curiae maintain, supported by voluminous

scientific research, that early COVID-19 treatments

with hydroxychloroquine (“HCQ”) and Nobel prizewinning Ivermectin are quite safe and effective,

contrary to the incessant government narratives

against such treatment options.35,36,37 These are

reasonable

alternatives

to

more

dangerous

experimental mRNA injections, as determined

within each protected doctor/patient relationship.

Amici Curiae maintain, supported by voluminous

scientific research, that experimental mRNA

injections are neither “safe” nor “effective.”

35 A white paper draws attention to the indisputable safety of

hydroxychloroquine (“HCQ”), an analog of the quinine from tree

barks that George Washington used to protect his troops. “A

White Paper on Hydroxychloroquine,” by Dr. Simone Gold,

M.D., J.D., is the culmination of months-long research from all

sources. All the myths and misconceptions about a safe, generic

drug, FDA-approved for 65 years and given to pregnant and

breast-feeding women, children, the elderly, and the immunecompromised for decades without complication, are finally put

to rest. https://americasfrontlinedoctors.org/index/covid/hydro

xychloroquine/white-paper/

36 As of August 31, 2026, a global, real-time meta-analysis

includes 424 Hydroxychloroquine (“HCQ”) COVID-19 studies,

from more than 8,646 scientists and 591,536 patients in 59

countries. The studies indicate a statistically significant

improvement for mortality, hospitalization, recovery, cases, and

viral clearance, and there is 66 percent less death in 38 early

treatment trials. See https://c19hcq.org/

37 As of September 18, 2026, a global, real-time meta-analysis

includes 106 Ivermectin COVID-19 studies. The studies indicate

Ivermectin reduces risk for COVID-19 with very high

confidence for mortality, ventilation, ICU admission,

hospitalization, and recovery. Over 20 countries adopted

Ivermectin for COVID-19 and it may now be purchased over the

counter in many states. https://c19ivm.org/

– 23 –

V.

“Mandating” dangerous experimental

drugs — drugs never approved by the

FDA, despite erroneous media reports

to the contrary — absent voluntary,

coercion-free

informed

consent

violates

well-established

constitutional principles, including the rights

to refuse medical treatment and of

personal bodily integrity; violates civil

and criminal federal and state laws

prohibiting medical battery, negligent

injuring,

assault,

and

negligent

homicide; and violates numerous

federal regulations requiring informed consent and full disclosure,

including 21 U.S.C. §360bbb-3, 21

C.F.R. §50.20, 21 C.F.R. §50.25, 45 C.F.R.

§46.116, and the Nuremberg Code.

Although the mandated mRNA injections are

investigational, Respondents did not comply with

well-established regulations governing informed and

voluntary patient consent for experimental,

investigational drugs, free from coercion and undue

influence, and with full disclosure of the risks. See 21

C.F.R. §50.20, 21 C.F.R. §50.25, and 45 C.F.R.

§46.116, “Protection of Human Subjects,” long known

as the “Common Rule.”38

These federal regulations are mandatory for

public actors, embody most of the Nuremberg

principles, and apply to all experimental drugs

issued under an emergency use authorization (EUA),

38 https://www.hhs.gov/ohrp/regulations-and-policy/regulations/

common-rule/index.html

– 24 –

pursuant to 21 U.S.C. §360bbb-3. These experimental gene therapy injections promoted by

Respondents were always only offered under an

EUA, and were never approved by the FDA.39 The

controversial approval of “Comirnaty,” a legally

distinct drug from Pfizer BioNTech COVID-19

vaccine, with somewhat differing formulations,

different manufacturing oversight and differing

adverse reactions, did not change the experimental

EUA nature of the various COVID-19 gene therapy

injections actually in use in the United States and

still under EUA.

As pointed out by the Third Circuit, numerous

circuits have erroneously concluded that Pfizer’s

COVID-19 injection was approved by the FDA,40 but

only Pfizer drug “Comirnaty” was approved while the

EUA COVID-19 injection was extended. Both actions

were taken on August 23, 2021, causing much

confusion. The Third Circuit erred in finding that

these two different drugs were equivalent. Only

Comirnaty was approved by the F.D.A., and it was

On August 23, 2021, the FDA approved a COVID-19 drug

called “Comirnaty,” with a long list of required future safety

studies; however, Comirnaty was not in use in the United

States. On the same day, the FDA extended the EUA for the

experimental mRNA COVID-19 drugs actually in use. This

created much confusion; it was erroneously reported that the

mRNA injections actually in use had been approved by the

FDA. This was never true. The EUA for the experimental

mRNA injections was only extended. Therefore, all laws and

regulations applicable to experimental drugs were still in full

force and effect at the time of the mandates. See

https://www.fda.gov/media/151710/download

40 See John Does 1–2 v. Hochul, No. 24-1015, Appendix at 20a,

21a, and 39a.

39

– 25 –

never available in the United States to be utilized in

any hospital “mandate” such as Shriners’.

Studies have demonstrated differences between

Comirnaty and the mandated EUA COVID-19

injections. The mandated EUA COVID-19 injections

have been found to have higher rates of Myocarditis,

which can be fatal.41,42 The approval of Comirnaty

did not nullify the applicability of 21 U.S.C. §360bbb3, the informed consent regulations, or the

constitutional and statutory provisions.

Because Respondents coercively promoted an

experimental drug, these informed consent and full

disclosure regulations were also mandatory.

The Nuremberg Code, an international code of

ethical principles adopted in the aftermath of WWII

A paper authored by Luigi Cari and others shows that

Spikevax-Moderna mRNA induces higher spike protein

expression per dose than Comirnaty, and this correlates with

increased myocarditis risk. See “Differences in the expression

levels of SARS-CoV-2 Spike Protein in cells treated with

mRNA-based COVID-19 vaccines: A study on vaccines from the

real world.” Vaccines (Basel) 11(4):879. Apr 21, 2023

https://pubmed.ncbi.nlm.nih.gov/37112792/

Jesús Hermosilla, et al. “Analysing the in-use stability of

mRNA-LNP COVID-19 vaccines Comirnaty™ (Pfizer) and

Spikevax™ (Moderna): A comparative study of the particulate.”

Vaccines (Basel) 11(11):1635. Oct 25, 2023. https://pub

med.ncbi.nlm.nih.gov/38005967/

Lizhou Zhang, et al. “Effect of mRNA-LNP components of

two globally-marketed COVID-19 vaccines on efficacy and

stability.” NPJ Vaccines 8(1):156 (2023). https://pubmed.ncbi.

nlm.nih.gov/ 37821446/

42 Josh Guetzkow and Retsef Levi. “Effect of mRNA vaccine

manufacturing processes on efficacy and safety still an open

question,” BMJ 2022;378:o1731. July 12, 2022. https://www.

bmj.com/content/378/bmj.o1731/rr-2

41

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Nazi war crimes, was expressly intended to prohibit

involuntary medical experimentation upon humans

The detailed federal regulations mirror the

Nuremberg Code.43 For example, 21 C.F.R. §50.25,

Elements of informed consent, requires the

identification of any experimental procedures, a

description of any reasonably foreseeable risks or

discomforts, a description of any benefits, a

disclosure of alternative procedures, and a statement

that refusal to participate will involve no penalty.

The threat of job loss totally nullified voluntary

employee/patient consent, free from threat and

undue influence as required by 21 C.F.R.

§50.25(a)(8). No attempt was made to advise the

employee/patients of the substantial known risks of

these experimental drugs as required by 21 C.F.R.

Part 50.

Federal law thus guarantees that investigational

drugs must only be offered on a voluntary basis after

full disclosure of risks, and with voluntary informed

consent free from coercion. See 21 U.S.C. § 360bbb-3,

21 C.F.R. §50.20, 21 C.F.R. §50.25, and 45 C.F.R.

§46.116. Consent can never be coerced.

21 U.S.C. §360bbb-3 mandates that the

administration of experimental biological agents are

strictly voluntary, requiring informed consent after a

full disclosure of risks. This principle is binding upon

Respondents in their capacity as state actors and via

their contractual agreements to do so. Respondents

Trials of War Criminals Before the Nuernberg Military

Tribunals Under Control Council Law No. 10, Volume II (U.S.

Government Printing Office 1949), p. 181. https://www.guten

berg.org/ebooks/54905

43

– 27 –

violated these

regulations.

mandatory

federal

laws

and

The constitutional principles guaranteeing every

individual the right to refuse medical treatment and

the right of personal bodily integrity are similarly

well-established, and were also willfully ignored by

the Respondents. See, e.g., Cruzan, 497 U.S. at 270

(“the logical corollary of the doctrine of informed

consent is that the patient generally possesses the

right not to consent, that is, to refuse treatment”);

Washington v. Harper, 494 U.S. 210, 229 (1990) (“the

forcible injection of medication into a nonconsenting

person’s body represents a substantial interference

with that person’s liberty”); Schloendorff v Society of

New York Hospital, 211 N.Y. 125, 129 (1914)

(“[e]very human being of adult years and sound mind

has a right to determine what shall be done with his

own body”); and Canterbury v. Spence, 464 F.2d 772,

780 (1972) (“the root premise is the concept,

fundamental in American jurisprudence, that ‘[e]very

human being of adult years and sound mind has a

right to determine what shall be done with his

body…’ True consent to what happens to one’s self is

the informed exercise of a choice”). See also Doe #1 v.

Rumsfeld, 297 F. Supp. 2d 119, 134–35 (D.D.C. 2003)

(“United States cannot demand that members of the

armed forces also serve as guinea pigs for

experimental drugs” (emphasis added)); Downer v.

Veilleux, 322 A.2d 82 (Me. 1974); and Cobbs v. Grant,

8 Cal.3d 229 (1972).

In Vacco v. Quill, 521 U.S. 793, 800 (1997), this

Court stated, “Everyone, regardless of physical

condition, is entitled, if competent, to refuse

– 28 –

unwanted lifesaving medical treatment.” (emphasis

added).

Courts have consistently upheld a patient’s wellestablished right to refuse unwanted medical

treatments on constitutional grounds for decades. See

Mills v. Rogers, 457 U.S. 291 (1982) Guardianship of

Roe, 383 Mass. 415 (1981), Riggins v. Nevada, 504

U.S. 127 (1992), and Sell v. United States, 539 U.S.

166 (2003).

State criminal laws prohibiting assault, battery,

and negligent homicide are implicated. Federal

criminal laws prohibiting the violation of

constitutional rights are implicated. See 18 U.S.C.

§241.

Preservation of the absolute right of voluntary,

informed patient consent and medical freedom, and

the constitutional right to refuse personal medical

treatment are paramount considerations here.

Informed and voluntary consent to medical

treatments can never be coerced under the threat of

losing one’s livelihood. Unwitting and unwilling

medical experimentation upon humans is abhorrent

and cannot be upheld.

CONCLUSION

It is undisputed that forced or coerced experimentation on human beings against their will is

reprehensible and should never be allowed by any

court, as the lessons of Nuremberg and the Tuskegee

experiment teach.44

44

See Elizabeth Nix. “Tuskegee Experiment: The Infamous

– 29 –

The petition for certiorari should be granted and

the ruling below should be reversed.

Respectfully submitted,

DAVID A. DALIA

Counsel of Record

Attorney at Law

700 Camp Street

New Orleans, LA 70130

(504) 524-5541

davidadalia@gmail.com

Counsel for Amici Curiae,

America’s Frontline Doctors and

Dr. Simone Gold, M.D., J.D.

September 18, 2026

Syphilis Study,” History, May 16, 2017. https://www.

history.com/news/the-infamous-40-year-tuskegee-study