Amicus Curiae Brief — Jessica Sweeney, et al., Petitioners v. University of Colorado Hospital Authority, et al.

No. 25-1055

In the

Supreme Court of the United States

________________________

JESSICA SWEENEY, et al.,

Petitioners,

v.

UNIVERSITY OF COLORADO HOSPITAL

AUTHORITY, et al.,

Respondents.

________________________

On Petition for a Writ of Certiorari to the United

States Court of Appeals for the Tenth 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

Counsel of Record

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 .............................................. 4

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

A.

Cruzan v. Dir., Mo. Dep’t of Health

requires strict scrutiny of personal

medical treatment mandates; the courts

below erred in applying rational basis

review to Respondents’ actions in

coercively “mandating” a dangerous

experimental treatment which does not

prevent infection or transmission, and

which has severe undisclosed side

effects, including death. The illegal

mandate under coercive threat of loss of

employment violates informed consent,

well-established constitutional provisions, and numerous civil and criminal

laws and regulations. Governments are

increasingly recognizing such mandates

as irrational and against public policy. ......... 5

B.

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

– ii –

adverse reactions, disabilities and

hospitalizations and a tragic 39,050

fatalities attributable to these mRNA

injections through February 27, 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............................................................. 13

C.

“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 in-formed 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. ......................................... 20

D.

The CDC’s operational guidance for

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

– iii –

program was implemented in adherence with federal guidance and

requirements. All actors involved in the

federal distribution program were

legally bound to comply with federal

rules concerning investigational drugs. ...... 26

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

– iv –

TABLE OF AUTHORITIES

CASES

PAGE(S)

303 Creative LLC v. Elenis,

600 U.S. 570 (2023) .............................................. 12

Canterbury v. Spence,

464 F.2d 772 (1972)........................................ 24–25

Chiles v. Salazar,

145 S. Ct. 1328 (2025) ...................................... 1, 11

Cobbs v. Grant,

8 Cal.3d 229 (1972) .............................................. 25

Cooper v. Roswell Park Comprehensive Cancer

Center, 196 N.Y.S.3d 325 (Sup. Ct. 2023) ............. 7

Cruzan v. Dir., Mo. Dep’t of Health,

497 U.S. 261 (1990) .................................. 4, 5, 6, 24

Doe #1 v. Rumsfeld,

297 F. Supp. 2d 119 (D.D.C. 2003) ...................... 25

Downer v. Veilleux,

322 A.2d 82 (Me. 1974) ........................................ 24

Georgia v. President of the United States,

46 F.4th 1283 (11th Cir. 2022) ............................ 10

Grimes v. Kennedy Krieger Institute,

362 Md. 623 (2001)............................................... 23

–v–

Guardianship of Roe,

383 Mass. 415 (1981)............................................ 25

John Does 1–2 v. Hochul,

No. 24-1015 (2025) ......................................... 12, 21

Kory v. Bonta,

No. 24-932 (2025) ................................................. 12

Masterpiece Cakeshop, Ltd. v. Colorado

Civil Rights Comm’n, 584 U.S. 617 (2018) .......... 12

Medical Professionals for Informed Consent v.

Bassett, 78 Misc. 3d 482

(Sup. Ct. Jan. 13, 2023)........................................ 11

Miller v. McDonald,

223 L. Ed. 2d 270 (2025) ...................................... 10

Mills v. Rogers,

457 U.S. 291 (1982) .............................................. 25

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

595 U.S. 109 (2022) ......................................... 2, 10

Riggins v. Nevada,

504 U.S. 127 (1992) .............................................. 25

Schloendorff v Society of New York Hospital.

211 N.Y. 125 (1914) .............................................. 25

Sell v. United States,

539 U.S. 166 (2003) .............................................. 25

– vi –

Texas v. Becerra,

577 F.Supp.3d 527 (N.D. Tex. 2021) ................... 10

Texas v. Becerra,

667 F.Supp.3d 252 (N.D.Tex. 2023) .................... 10

Vacco v. Quill,

521 U.S. 793 (1997) .............................................. 25

Washington v. Harper,

494 U.S. 210 (1990) .............................................. 24

Wilkinson v. Washington Med. Comm'n,

35 Wn. App. 2d 350 (2025)............................... 4, 11

STATUTES AND REGULATIONS

18 U.S.C. §241 ........................................................... 25

21 U.S.C. §360bbb-3 ............................ 5, 20, 21, 22, 24

21 C.F.R. Part 50 ....................................................... 23

21 C.F.R. §50.20 .............................................. 5, 20, 24

21 C.F.R. §50.25 ........................................ 5, 20, 23, 24

45 C.F.R. Part 46 ....................................................... 24

45 C.F.R. §46.116 ............................................ 5, 20, 24

Iowa House File 712, Bill SF360 ................................ 9

Kentucky House Bill 469 ............................................ 9

– vii –

Montana House Bill 371 .............................................. 9

Idaho Senate Bill 1036 ................................................ 9

Minnesota HF 3152, HF 3219 ..................................... 9

FEDERAL REGISTER

86 Fed. Reg. 5202 ........................................................ 6

FEDERAL RULES

F. R. Civ. P. 12(b)(6) .............................................. 5, 27

OTHER REFERENCES

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week [No causes of death were listed],”

https://markcrispinmiller.substack.com/p/33nurses-died-suddenly-in-the-us ............................. 7

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 .......................................... 16

– viii –

CDC,

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

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id-19-Vaccination-Program-Interim_Playbo

ok.pdf .................................................................... 26

Luigi Cari, et al. “Differences in the expression

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

2792 ...................................................................... 22

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

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FDA Safety Communication. “FDA Approves

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ability-biologics/fda-approves-required-upda

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

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“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 ................................................................... 10

– ix –

“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/ ........................................ 10

“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 ........................................................8-9

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

Hydroxychloroquine,” https://americasfront

linedoctors.org/index/covid/hydroxychloroq

uine/white-paper/ ........................................... 18–19

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 .................................. 22

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................................. 15

–x–

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 ........................................................ 22

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/ ..................................................... 19

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

icy/regulations/common-rule/index. html ........... 20

https://c19ivm.org/ ..................................................... 19

https://openvaers.com/covid-data.......................... 6, 13

https://www.foxnews.com/politics/coloradolawyers-say-court-e-file-system-nowmakes-them-certify-wont-assist-ice .................... 12

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

250639592 ............................................................ 16

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

11008138 ................................................................ 7

– xi –

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 ..................................... 18

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 .................................... 15

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 ............................................................. 8

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............................... 14

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 ......... 8

– xii –

“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........... 9

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 ............................... 17

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 .......................................... 8

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) ......................... 16

– xiii –

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/ .......................................................... 14

National Commission for the Protection of

Human Subjects of Biomedical and

Behavioral Research. Belmont Report:

Ethical Principles and Guidelines for the

Protection of Human Subjects of Research,

U.S. Department of Health and Human

Services, April 18, 1979. https://www.hhs.

gov/ohrp/sites/default/files/the-belmont-rep

ort-508c_FINAL.pdf ............................................. 27

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/ ................................................................ 10

“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 ....................................... 11

Elizabeth Nix. “Tuskegee Experiment: The

Infamous Syphilis Study,” History, May 16,

2017.

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

– xiv –

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................................ 8

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 ......... 8

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 ..................................... 15

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/ ....... 15

David J. Speicher, et al. “Quantification of

residual plasmid DNA and SV40 promoterenhancer sequences in Pfizer/BioNTech

and Moderna modRNA COVID-19 vaccines

from Ontario, Canada,” Autoimmunity,

December 2025, 58(1):2551517. https://pub

med.ncbi.nlm.nih.gov/40913499/ ......................... 17

– xv –

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/ ........................................... 17

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 ......................................... 22

“TRUTH BOMB: Peter McCullough Doesn’t

Hold Back — ‘IT WAS NOT SAFE BY

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

/1925355939369988144 .......................................... 7

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/ ...... 22

–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 (“Amici Curiae”

or “AFLDS”) respectfully file this amici curiae brief

in support of the Petitioners for reversal in Jessica

Sweeney, et al., v. University of Colorado Hospital

Authority, et al., No. 25-1055.1

Amici Curiae filed amici briefs in recent cases

affecting public health and medical freedom such as

Does 1-2 v. Hochul, No. 24-1015; Kory v. Bonta, No.

24-932; Foote v. Ludlow School Committee, No. 2577; Lee v. Poudre School District R-1, No. 25-89;

Stockton v. Brown, No. 25-606; Mirabelli v. Bonta,

No. 25A810; Lavigne v. Great Salt Bay Community

School Board, No. 25-759; and International Partners

for Ethical Care, Inc. v. Ferguson, No. 25-840, six of

which cases are under consideration at this time.

AFLDS also filed briefs in cases recently decided

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

223 L. Ed. 2d 270 (2025); United States v. Skrmetti,

605 U.S. 495 (2025); Mahmoud v. Taylor, 606 U.S.

522 (2025), Chiles v. Salazar, 145 S. Ct. 1328 (2025),

1 No counsel or any party authored or prepared this brief in

whole or in part, and no such counsel or party made a monetary

contribution intended to fund the preparation or submission of

this brief. The parties received timely notice of the filing of this

amici curiae brief.

–2–

and Nat’l Fed’n of Indep. Bus. v. OSHA, 595 U.S. 109

(2022).

This amici curiae brief offers an important

medical and legal perspective to this Court on a

matter of great public importance, by demonstrating

that the Respondents engaged in unconstitutional,

illegal, and possibly criminal activity by “mandating”

dangerous experimental medical treatments in

violation of informed consent, 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

AFLDS Amici Curiae is a non-partisan, not-forprofit 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 Dr. Simone Gold,

M.D., J.D., its founder and expert physician, with

over twenty years experience as an emergency room

physician in minority communities around the

nation.

AFLDS’

including:

programs

focus

• Providing Americans

facts about COVID-19;

on

with

critical

issues,

science-based

–3–

• Protecting physician independence

government overreach;

from

• Combating COVID-19 with evidence-based

approaches without compromising constitutional freedoms;

• Fighting medical cancel culture and media

censorship;

• Advancing healthcare policies that protect

the physician-patient relationship;

• Expanding COVID-19 treatment options for

all Americans who need them; and

• 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.”2 They are personal

medical treatments only. 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.

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

2

–4–

SUMMARY OF ARGUMENT

Cruzan v. Dir., Mo. Dep’t of Health, 497 U.S. 261

(1990) and its progeny require strict scrutiny of any

personal medical treatment mandates. The courts

below erred in applying a mere rational basis review

of Respondents’ actions in coercively “mandating”

dangerous and possibly fatal experimental drugs

which do not protect other people.

Illegally mandating 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

informed consent, well-established constitutional

provisions, numerous civil and criminal laws and

regulations, is irrational and against public policy.

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.

Recently, in Wilkinson v. Washington Med.

Comm'n, 35 Wn. App. 2d 350 (Wash. Ct. App. 2025),

the Washington Court of Appeals found discipline of

a physician for his viewpoint against COVID-19

injections is violative of the First Amendment, a

ruling denied review by the Washington Supreme

Court. Given this Court’s precedents, the Colorado

government’s COVID-19-era policy favoring mRNA

injections can likewise be viewed as unconstitutional

viewpoint discrimination.

–5–

At the time of Respondents’ “mandate,” the

mRNA injections were indisputably investigational.

Thus, the detailed 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, and were

violated in this case.

Respondent public actors contractually agreed to

act with all of the attendant (and crucially

important) informed consent and constitutional

responsibilities and obligations.

Discovery has not yet begun in this case, which

should not be dismissed via a premature Rule

12(b)(6) motion. 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 petition for a writ of certiorari should be

granted.

ARGUMENT

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

requires strict scrutiny of personal

medical treatment mandates; the

courts below erred in applying rational

basis review to Respondents’ actions in

coercively “mandating” a dangerous

experimental treatment which does not

prevent infection or transmission, and

which has severe undisclosed side

–6–

effects, including death. The illegal

mandate under coercive threat of loss

of employment violates informed

consent, well-established constitutional

provisions, and numerous civil and

criminal laws and regulations. Governments are increasingly recognizing

such mandates as irrational and

against public policy.

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.3 These

experimental, investigational drugs offer no

protection for other people.4 They are personal

medical treatments only.

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

U.S. 261, 270, 282 (1990) requires strict scrutiny of

any personal medical treatment mandate, the courts

below erred in applying a mere rational basis review

of Respondents’ actions in coercively “mandating”

dangerous experimental drugs which do not protect

other people. Reversal on this ground alone is called

for.

3 See https://openvaers.com/covid-data, and Section B, infra.

4 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).

–7–

Mandating dangerous investigational drugs is

irrational and against 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.”5

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,

changing previous CDC recommendations.6

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.7

Many more recent and reliable medical studies

further explode the “safe and effective” narrative.8

5 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-diedsuddenly-in-the-us

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

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

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

status/1925355939369988144

8 Five recent papers show vaccine COVID vaccine harms

–8–

Florida state Surgeon General Dr. Joseph A.

Ladapo called for a complete halt in the use of

COVID-19 mRNA “vaccines,” citing contamination

concerns.9

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 (.5, highly statistically

significant) between vaccination and death. 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

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

9

“[Ladapo] outlined concerns regarding nucleic acid

contaminants in the approved Pfizer and Moderna COVID-19

mRNA vaccines, particularly in the presence of lipid

nanoparticle complexes, and Simian Virus 40 (SV40)

promoter/enhancer DNA.” “Florida State Surgeon General Calls

–9–

Louisiana health officials shifted away from

promoting COVID-19 and flu vaccinations.10 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

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.11

If these investigational drugs were truly safe,

why are many states seeking to ban them?

for Halt in the Use of COVID-19 mRNA Vaccines.”

https://www.floridahealthgov/newsroom/2024/01/20240103-haltuse-covid19-mrna-vaccines.pr.html

10 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

11 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.

– 10 –

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.12,13

The rulings 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).

“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 several 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/

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

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

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

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

12

– 11 –

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.14

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.

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?

Further, recent decisions such as Chiles v.

Salazar, 145 S. Ct. 1328 (2025) (Colorado’s therapeutic

speech restriction law is viewpoint discrimination

violative of the First Amendment), and Wilkinson v.

Washington Med. Comm'n, 35 Wn. App. 2d 350, 391,

401 (Wash. Ct. App. 2025), review denied,

Washington Supreme Court, No. 1046740, March 31,

2026 (state commission’s discipline of physician for

advocating against mRNA injections is viewpoint

discrimination violative of the First Amendment)

demonstrate that the Colorado state government’s

These issues are extremely likely to recur, yet are evading

review. Threats of new pandemics are coming in from many

quarters. Further, numerous anti-mandate cases like this one

have flooded American courts. This is likely to continuously

recur if not corrected now. See “New risks raise pandemic threat

on a global scale,” https://www.gpmb.org/news/news/item/14-102024-new-risks-raise-pandemic-threat-on-a-global-scale

14

– 12 –

COVID-19-era policy favoring mRNA injections can

now be seen as unconstitutional viewpoint

discrimination as well.

Colorado’s viewpoint discrimination via COVID19-era policies is similar to the First Amendment

violations experienced in two other cases before this

Court: Kory v. Bonta, No. 24-932 (compelled and

favored vs. censored and disfavored physician therapeutic speech in California) and John Does 1-2 v.

Kathy Hochul, No. 24-1015 (favored state-mandated

medical treatment vs. disfavored medical treatment).

Previous Colorado First Amendment violations

were corrected by this Court in 303 Creative LLC v.

Elenis, 600 U.S. 570 (2023), and in Masterpiece

Cakeshop, Ltd. v. Colorado Civil Rights Comm’n, 584

U.S. 617 (2018).

Colorado’s most recent foray into viewpoint

discrimination and compelled speech, effective March

30, 2026, is a requirement that Colorado attorneys,

in order to access the state court e-filing system,

must certify that they will not use personal

information to cooperate with, or assist in, federal

immigration enforcement. An attorney who declines

to certify is denied access to the e-filing system.15

This indefensible policy will presumably be struck

down soon.

Meanwhile, Sweeney is an opportunity for the

Colorado COVID-19-era policy unconscionably

“Colorado lawyers say court e-file system now makes them

certify they won’t assist ICE,” April 3, 2026. https://www.foxnews.

com/politics/colorado-lawyers-say-court-e-file-system-now-makesthem-certify-wont-assist-ice

15

– 13 –

endorsed by the court below to be likewise found

unconstitutional on First Amendment grounds.

B. 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 39,050

fatalities attributable to these mRNA

injections through February 27, 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 February 27,

2026, there have been 39,050 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.”16 This cannot reasonably

be considered “safe” or “effective.” Additionally,

VAERS recorded 74,578 permanently disabled

persons, 222,446 hospitalizations, 157,782 urgent

care visits, 250,089 doctor visits, 18,008 cases of

Bell’s Palsy, 5,216 miscarriages, 22,486 heart

attacks, 29,188 Myocarditis/Pericarditis cases, and

11,001 cases of Anaphylaxis.17

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

17 These figures are even more astonishing when it is considered

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

– 14 –

Thus the American reported death toll has now

risen to an astonishing 39,050 deaths. This shocks

the conscience. Even if only a certain percentage of

these COVID-19 mRNA injection adverse reaction

reports are accurate, the death toll and the

accompanying risks remain unacceptable. How can

anyone mandate something that might kill you?

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.18 The New York Times

reported on October 13, 1976 that the swine flu

events and fatalities due to the COVID-19 injections. In 2011,

an investigation of VAERS by Harvard Pilgrim Health Care

Inc. reported: “Adverse events from drugs and vaccines are

common, but underreported. … fewer than 1% of vaccine

adverse events are reported [to the FDA]. Low reporting rates

preclude or slow the identification of ‘problem’ drugs and

vaccines that endanger public health. New surveillance

methods for … vaccine adverse effects are needed.” See 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

/r18hs017045-lazarus-final-report-2011.pdf

18 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/

– 15 –

program was halted in nine states after only three

deaths were attributed to the vaccine shots.19

Japanese researchers linked these experimental

mRNA injection side effects to 201 types of

diseases.20 In another Japanese study, researchers

found on autopsy multiple micro-scars in the hearts

of mRNA-vaccinated patients who died suddenly of

unexplained cardiac arrest, thus raising the question

of a link between the experimental mRNA injections

and sudden cardiac arrest.21 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.22

Further, an alarming Yale study showed that

COVID vaccines may cause T-cell exhaustion,

leading to an acquired immune deficiency. Could this

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

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

1976.

20 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

21 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

22 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

– 16 –

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

strengthening it?”23

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.”24

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.25

A recent analysis used fluorometry, and found

total DNA in all vials tested exceeded the regulatory

limit for residual DNA set by the FDA and the World

Health Authorization by 36–153-fold for Pfizer and

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

24 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://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)

25 “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

23

– 17 –

112–627-fold for Moderna after accounting for

nonspecific binding to modRNA.26

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.27

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:28

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,

26 David J. Speicher, et al. “Quantification of residual plasmid

DNA

and

SV40

promoter-enhancer

sequences

in

Pfizer/BioNTech and Moderna modRNA COVID-19 vaccines

from Ontario, Canada,” Autoimmunity, December 2025,

58(1):2551517. https://pub med.ncbi.nlm.nih.gov/40913499

27 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

28 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/

– 18 –

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.”29

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.

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.30,31,32 These are

29 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

30 A white paper draws the reader’s attention to the

– 19 –

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.”

indisputable safety of hydroxychloroquine (“HCQ”), an analog of

the same quinine found in 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 that has

been FDA approved for 65 years, given to pregnant women,

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

finally put to rest. https://americasfrontlinedoctors.org/index/

covid/hydroxychloroquine/white-paper/

31 As of July 4, 2025, 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. At

least 406 studies are peer reviewed, with 402 comparing

treatment and control groups. 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/

32 As of September 16, 2025, 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, recovery, cases and viral clearance. (No

treatment, vaccine, or intervention is 100 percent effective and

available.) Thus all practical, effective, and safe means should

be used based on risk/benefit analysis. Over 20 countries

adopted Ivermectin for COVID-19. Ivermectin may now be

purchased over the counter in the state of Tennessee and many

other states. https://c19ivm.org/

– 20 –

C.

“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.”33

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),

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

common-rule/index.html

– 21 –

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.34 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.

Lower courts have at times erroneously

concluded that Pfizer’s COVID-19 injection was

approved by the FDA,35 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.

Studies have demonstrated differences between

Comirnaty and the mandated EUA COVID-19

injections. The mandated EUA COVID-19 injections

34 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 which were actually in

U.S. 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 of the laws and regulations applicable to experimental drugs

were still in full force and effect at the time of the mandate. See

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

35 See John Does 1–2, et al., v. Kathy Hochul, Governor of New

York, et al., No. 24-1015, Appendix B (E.D.NY opinion) at 14a;

Appendix A (2nd Cir. 2024 opinion) at 20a, 21a, and 39a.

– 22 –

have been found to have higher rates of Myocarditis,

which can be fatal.36,37 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 detailed federal regulations mirror the

Nuremberg Code.38 For example, 21 C.F.R. §50.25,

Elements of informed consent, provides:

36 A paper authored by Luigi Cari and others shows that

Spikevax-Moderna mRNA induces higher spike protein

expression per dose than Comirnaty, and this higher dose

correlates with increased myocarditis risk compared to

Comirnaty. See 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/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/

37 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

38 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

– 23 –

(a) Basic elements of informed consent ... the

following information shall be provided ...

(1) ... identification of any procedures which

are experimental.

(2) A description of any reasonably

foreseeable risks or discomforts ...

(3) A description of any benefits to the

subject ...

(4) A disclosure of appropriate alternative

procedures or courses of treatment ...

(5)–(7) …

(8) A statement that participation is

voluntary, that refusal to participate will

involve no penalty or loss of benefits ...

(b) Additional elements of informed consent:

(1)–(6).

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. See also Grimes v. Kennedy Krieger

Institute, Inc., 366 Md. 29 (Md. 2001) (enforcing

principles of informed consent and Nuremberg in a

Maryland poisoning case).

The Nuremberg Code, an international code of

ethical principles adopted in the aftermath of

German Nazi war crimes committed during WWII,

was expressly intended to prohibit involuntary

medical experimentation upon humans. The

“informed consent” Nuremberg principles have been

largely codified domestically through the adoption of

– 24 –

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

Part 46 (the “Common Rule”).

Federal law, incorporating most of the

Nuremberg Code, 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

violated these mandatory federal laws and

regulations.

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 v. Dir., Mo. Dep’t.

of Health, 497 U.S. 261, 270 (1990) (“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)

– 25 –

(“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

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

– 26 –

losing one’s livelihood. Unwitting and unwilling

medical experimentation upon humans is abhorrent

and cannot be upheld.

D. The CDC’s operational guidance for

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 federal guidance and

requirements. All actors involved in the

federal distribution program were

legally bound to comply with federal

rules concerning investigational drugs.

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

stated goal of closely monitoring vaccination

activities at the local level to ensure that the COVID19

Vaccination

Program

(“Program”)

was

implemented through-out the local jurisdiction “in

adherence with federal guidance and requirements.”39

This contractually imposed affirmative obligations

upon states and state providers to comply with all

federal guidance and requirements, including all

informed consent provisions discussed above as a

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

39

– 27 –

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.

Respondents cannot evade their contractual

responsibilities and obligations to follow constitutional provisions guaranteeing the right to refuse

medical treatments, and the informed consent

regulations based upon the Nuremberg Code and the

Belmont Report,40 under the Program.

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 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.41

40 The National Commission for the Protection of Human

Subjects of Biomedical and Behavioral Research. Belmont

Report: Ethical Principles and Guidelines for the Protection of

Human Subjects of Research, April 18, 1979. See https://

www.hhs.gov/ohrp/sites/default/files/the-belmont-report-508c_

FINAL.pdf

41 As described by Petitioners in their petition for certiorari.

– 28 –

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.42 Fortunately, legal protections

have been implemented against such injustices, and

these protections preclude the enforcement of

involuntary experimental, investigational — and

literally life-threatening — medical mandates such

as those promoted by the Colorado Respondents

herein.

Any illegal mandate of a dangerous experimental

personal medical treatment, under the coercive

threat of loss of employment, especially when such

treatment does not prevent infection or transmission

and has severe undisclosed side effects including

death — clearly violating informed consent, the

Constitution, and the numerous well-established

laws enumerated herein — is irrational and against

public policy.

The petition for certiorari should be granted and

the rulings below should be reversed.

See Elizabeth Nix. “Tuskegee Experiment: The Infamous

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

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

42

– 29 –

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.

April 6, 2026