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Nos. 21A243, 21A244, 21A245, 21A246, 21A247, 21A248, 21A249,
21A250, 21A251, 21A252, 21A258, 21A259, 21A260 and 21A267
In the
Supreme Court of the United States
NATIONAL FEDERATION OF
INDEPENDENT BUSINESS, et al.,
Applicants,
v.
DEPARTMENT OF LABOR, OCCUPATIONAL SAFETY
AND HEALTH ADMINISTRATION, et al.,
Respondents.
(For Continuation of Caption See Inside Cover)
On Emergency A pplications for Stay of Agency
Standard Pending the Disposition by the United States
Court of A ppeals for the Sixth Circuit of a Petition
for Review and any Further Proceedings in this Court,
or A lternatively, Petition for a Writ of Certiorari
Before Judgment and Stay Pending Resolution
MOTION OF WE THE PATRIOTS USA, INC. FOR
LEAVE TO FILE ATTACHED AMICUS BRIEF
IN SUPPORT OF APPLICATIONS FOR STAY OR
INJUNCTION PENDING REVIEW AND PETITIONS
FOR A WRIT OF CERTIORARI
BEFORE JUDGMENT AND FOR LEAVE
TO FILE WITHOUT 10-DAYS NOTICE
Norman A. Pattis
Counsel of Record
Cameron L. Atkinson
Pattis & Smith, LLC
383 Orange Street, 1st Floor
New Haven, Connecticut 06511
(203) 393-3017
npattis@pattisandsmith.com
December 30, 2021 Counsel for Amicus Curiae
309917
OHIO, et al.,
Applicants,
v.
DEPARTMENT OF LABOR, OCCUPATIONAL SAFETY
AND HEALTH ADMINISTRATION, et al.,
Respondents.
JOB CREATORS NETWORK, et al.,
Applicants,
v.
DEPARTMENT OF LABOR, OCCUPATIONAL SAFETY
AND HEALTH ADMINISTRATION, et al.,
Respondents.
PHILLIPS MANUFACTURING &
TOWER COMPANY, et al.,
Applicants,
v.
DEPARTMENT OF LABOR, OCCUPATIONAL SAFETY
AND HEALTH ADMINISTRATION, et al.,
Respondents.
THE SOUTHERN BAPTIST
THEOLOGICAL SEMINARY, et al.,
Applicants,
v.
DEPARTMENT OF LABOR, OCCUPATIONAL SAFETY
AND HEALTH ADMINISTRATION, et al.,
Respondents.
BST HOLDINGS, LLC, et al.,
Applicants,
v.
DEPARTMENT OF LABOR, OCCUPATIONAL SAFETY
AND HEALTH ADMINISTRATION, et al.,
Respondents.
THE HERITAGE FOUNDATION,
Applicant,
v.
DEPARTMENT OF LABOR, OCCUPATIONAL SAFETY
AND HEALTH ADMINISTRATION, et al.,
Respondents.
WORD OF GOD FELLOWSHIP, INC. D/B,
Applicants,
v.
DEPARTMENT OF LABOR, OCCUPATIONAL SAFETY
AND HEALTH ADMINISTRATION, et al.,
Respondents.
ASSOCIATED BUILDERS AND CONTRACTORS, INC.,
et al.,
Applicants,
v.
DEPARTMENT OF LABOR, OCCUPATIONAL SAFETY
AND HEALTH ADMINISTRATION, et al.,
Respondents.
SCOTT BEDKE, IN HIS OFFICIAL CAPACITY
AS SPEAKER OF THE IDAHO HOUSE OF
REPRESENTATIVES, et al. et al.,
Applicants,
v.
DEPARTMENT OF LABOR, OCCUPATIONAL SAFETY
AND HEALTH ADMINISTRATION, et al.,
Respondents.
REPUBLICAN NATIONAL COMMITTEE,
Applicant,
v.
DEPARTMENT OF LABOR, OCCUPATIONAL SAFETY
AND HEALTH ADMINISTRATION, et al.,
Respondents.
BETTEN CHEVROLET, INC.,
Applicant,
v.
DEPARTMENT OF LABOR, OCCUPATIONAL SAFETY
AND HEALTH ADMINISTRATION, et al.,
Respondents.
BENTKEY SERVICES, LLC, DBA THE DAILY WIRE,
Applicant,
v.
DEPARTMENT OF LABOR, OCCUPATIONAL SAFETY
AND HEALTH ADMINISTRATION, et al.,
Respondents.
FABARC STEEL SUPPLY, INC., et al.,
Applicant,
v.
DEPARTMENT OF LABOR, OCCUPATIONAL SAFETY
AND HEALTH ADMINISTRATION, et al.,
Respondents.
i
MOTION FOR LEAVE TO FILE
AMICUS CURIAE BRIEF
We The Patriots USA, INC. moves for leave to file
the attached brief as amicus curiae supporting the
applications to reinstate the stay of the Occupational
Safety and Health Administration’s emergency temporary
standard (ETS) mandating COVID-19 vaccinations or
testing and other precautions. It also moves for permission
to file its brief without ten days’ notice to the parties of its
intent to file as normally required by this Court’s 37.2(a).
The amicus curiae, We The Patriots USA, Inc., is
a national, nonpartisan, nonprofit membership charity
dedicated to promoting constitutional rights and other
freedoms through education, outreach, and public interest
litigation, thereby advancing religious freedom, medical
freedom, parental rights, and educational freedom for all.
It has funded and joined lawsuits on behalf of its members
against state COVID-19 vaccination mandates on religious
liberty and medical freedom grounds, including before
the Court. See, e.g., We The Patriots USA, Inc., et al. v.
Hochul, et al., No. 21A125. Many of its members will be
impacted by the Court’s decision.
The attached amicus brief articulates, for the Court’s
consideration, the rights and interests of the 80 million
Americans who have chosen not to get a COVID-19
vaccination and will lose their livelihoods if they remain
firm in their choices and the Court does not stay the ETS
– a perspective that the Applicants/Petitioners have only
acknowledged cursorily. It focuses on the reasons why
many Americans are hesitant to receive a COVID-19, and
it details their reliance on the historical rights of bodily
integrity and self-determination, which support their
ii
right to decline unwanted medical treatment. In doing
so, the amicus urges the Court to clarify its substantive
due process jurisprudence and subject the ETS to strict
scrutiny before it infringes on these rights that the Court
has described as sacred.
Additionally, the amicus provides the Court with
a more complete analysis of its Commerce Clause
jurisprudence that traces the Court’s requirement
that the principles of federalism prohibit Congress
from regulating noneconomic activity under its power
to regulate commerce. Its brief contains an important
detailed analysis of the Court’s modern Commerce Clause
jurisprudence with authorities that the Applicants/
Petitioners have not included in their applications for stays
and petitions for writs of certiorari before judgment.
Given the expedited briefing schedule that the Court
set in this case and its subsequent selection of the case
for expedited oral argument, it simply was not feasible
to give the parties ten days’ notice of the filing of this
brief. The Sixth Circuit granted the government’s motion
to dissolve the stay imposed by the Fifth Circuit on the
evening of December 17, 2021, and the applications for a
stay were filed in this Court on December 17, 18, and 20.
The Court set a briefing deadline of December 30, 2021 for
the Respondents’ briefs, and it scheduled oral argument
for January 7, 2022.
The Court’s treatment of this matter reflects its
overwhelming national importance, and it can be fairly
said that at least 25% of Americans have an interest
in its decision. Thus, the Court should liberally permit
interested amici to bring additional considerations to the
Court’s attention, especially when, like the amicus here,
iii
they express the interests held by a portion of the largest
affected portion of the population.
Additionally, the amicus and the undersigned have
been diligent in notifying the parties of their attention
to file as soon as they identified how they could be of
assistance through briefing to the Court. On December
23, 2021, the undersigned emailed all parties to the
applications/petitions notifying them of their intention to
file this brief and asking for their consent.
As of December 30, 2021, no party has opposed the
amicus’ filing of the attached brief. The Respondents have
not responded to the amicus’ notification regarding any of
the applications currently before the Court. Most of the
Applicants have consented or stated that they have no
objection, and others have not responded as listed below:
In No. 21A243, the Applicants have not responded.
In No. 21A244, all of the Applicants have stated that
they do not oppose the filing of the attached brief.
In. No. 21A245, the Applicants have not responded.
In No. 21A246, the Applicants have consented.
In No. 21A247, the Applicants have consented.
In No. 21A248, the Applicants have not responded.
In No. 21A249, the Applicant has stated that it does
not oppose the filing of the attached brief.
In No. 21A250, the Applicants have consented.
iv
In No. 21A251, the Applicants have consented.
In No. 21A252, the Applicants have stated that it does
not object to the filing of the attached brief.
In No. 21A258, the Applicant has consented.
In No. 21A259, the Applicant has stated that it does
not object to the filing of the attached brief.
In No. 21A260, the Applicant consented.
In No. 21A267, the Applicants have not responded.
Thus, in the absence of any objections and in light
of the tremendous importance of the questions before
the Court in these applications/petitions which have
necessitated its expedited consideration, the amicus
curiae respectfully ask the Court to permit it to file its
brief and to do so without the 10-day notice required by
Rule 37.2(a).
Respectfully submitted,
Norman A. Pattis
Counsel of Record
Cameron L. Atkinson
Pattis & Smith, LLC
383 Orange Street, 1st Floor
New Haven, Connecticut 06511
(203) 393-3017
npattis@pattisandsmith.com
Counsel for Amicus Curiae
December 30, 2021
i
TABLE OF CONTENTS
Page
TABLE OF CONTENTS . . . . . . . . . . . . . . . . . . . . . . . . . . i
TABLE OF CITED AUTHORITIES . . . . . . . . . . . . . . iii
INTEREST OF AMICUS CURIAE . . . . . . . . . . . . . . . 1
SUMMARY OF THE ARGUMENT . . . . . . . . . . . . . . . 1
ARGUMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
I. T here A re Ser ious Questions On
W het he r T he R i sk s O f C OV I D -19
Vaccinations Outweigh Their Rewards . . . . . . . . 4
II. The ETS Violates The Major-Questions
Doctrine Because Mandating Medical
Treatment For Vast Portions Of The
Population Is A Major Political And Economic
Question That Cong ress Has Never
Delegated To The Executive Branch Because
It Cannot Constitutionally Act Itself . . . . . . . . . . 8
A. The Court has implicitly narrowed
Ja cobso n v. Ma ssa chuset ts a nd
rejected a public health exception
to the Fourteenth Amendment . . . . . . . . . . 10
B. The Court’s precedents establish an
individual’s fundamental unenumerated
right under the Fourteenth Amendment
to make their own medical decisions . . . . . 15
ii
Table of Contents
Page
C. The ETS targets individuals who
exercise their right to make personal
medical decisions that contradict
the federal gover nment’s public
health recommendations . . . . . . . . . . . . . . . 18
III. Federalism Prohibits Congress From
Exercising Police Power To Enact General
Measures To Protect Public Health . . . . . . . . . 22
CONCLUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
iii
TABLE OF CITED AUTHORITIES
Page
Cases
Alabama Ass’n of Realtors v.
Dep’t of Health & Hum. Servs.,
141 S. Ct. 2485 (Aug. 26, 2021) . . . . . . . . . . . . . . . . . . . 9
Cruzan by Cruzan v.
Dir., Missouri Dep’t of Health,
497 U.S. 261 (1990) . . . . . . . . . . . . . . . . . . . 4, 15, 16, 17
Does 1-3, et al. v. Mills,
No. 21A90 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Dr. A., et al. v. Hochul, et al.,
No. 21A145 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Gibbons v. Ogden,
22 U.S. 1 (1824) . . . . . . . . . . . . . . . . . . . . . . . . . . . 23, 24
Gonzalez v. Raich,
545 U.S. 1 (2005) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Griswold v. Connecticut,
381 U.S. 479 (1965) . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Jacobson v. Massachusetts,
197 U.S. 11 (1905) . . . . . . . . . . . . . . . . . . . . . . . . passim
Korematsu v. United States,
323 U.S. 214 (1944) . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
iv
Cited Authorities
Page
Lawrence v. Texas,
539 U.S. 558 (2003) . . . . . . . . . . . . . . . . . . . . . 14, 15, 17
Lochner v. New York,
198 U.S. 45 (1905) . . . . . . . . . . . . . . . . . . . . . . 11, 16, 18
Meyer v. Nebraska,
262 U.S. 390 (1923) . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
N.F.I.B. v. Sebelius,
567 U.S. 519 (2012) . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Obergefell v. Hodges,
135 S.Ct. 2584 (2015) . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Planned Parenthood v. Casey,
505 U.S. 833 (1992) . . . . . . . . . . . . . . . . . . . . . 14, 15, 16
Roe v. Wade,
410 U.S. 113 (1973) . . . . . . . . . . . . . . . . . . . 13, 14, 15, 17
The Slaughter-House Cases,
83 U.S. 36 (1873) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Union Pac. R. Co. v. Botsford,
141 U.S. 250 (1891) . . . . . . . . . . . . . . . . . . . . . . . . 15, 17
United States v. Carolene Products Co.,
304 U.S. 144 (1938) . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
v
Cited Authorities
Page
United States v. Lopez,
514 U.S. 549 (1995) . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
United States v. Morrison,
529 U.S. 598 (2000) . . . . . . . . . . . . . . . . . . . . . . . . 23, 24
Washington v. Glucksberg,
521 U.S. 702 (1997) . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Washington v. Harper,
494 U.S. 210 (1990) . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
We The Patriots USA, Inc., et al. v. Hochul, et al.,
No. 21A125 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Wickard v. Filburn,
317 U.S. 111 (1942) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Statutes
21 U.S.C. § 360bbb-3 . . . . . . . . . . . . . . . . . . . . . . . . . . . 4, 5
29 U.S.C. § 669 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Other Authorities
21 C.F.R. § 601.51 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
vi
Cited Authorities
Page
Cameron L. Atkinson, A General Sovereign/
Public Employer Distinction: Should Garcetti
v. Ceballos Gover n Public Employment
C a s e s C o n c e r n i n g O f f- D u t y S e x u a l
Conduct Instead of Lawrence v. Texas?
38 Quinnipiac L. Rev. 325 (2020) . . . . . . . . . . . . . 12, 17
Carlie Porterfield, Dr. Fauci On GOP Criticism:
“Attacks On Me, Quite Frankly, Are Attacks
On Science,” Forbes.com (Jun. 9, 2021) . . . . . . . . . . 20
C ompl a i nt , Pu bli c He a l th An d Me di c a l
Professionals For Transparency v. Food
An d Dr u g Admini stratio n, Dk t . 4:21-
cv-01058 (N.D.T.X. Sept. 16, 2021) . . . . . . . . . . . . . . . 6
C O V I D - 1 9 Va c c i n a t i o n a n d Te s t i n g ;
E m e r g e n c y Te m p o r a r y S t a n d a r d ,
86 Fed. Reg. 61,402 (Nov. 5, 2021) . . . . . . . . . . . . . . . . 3
Daniel R. Lev inson, The Food And Dr ug
Administration’s Oversight Of Clinical Trials,
U.S. Dept. Of Health And Human Services,
Office of Inspector General (Sept. 2007) . . . . . . . . . . 7
Donald G. McNeil, Jr., How Much Herd Immunity
Is Enough? New York Times (Dec. 24, 2020) . . . . . 19
Gail A. Van Norman, Drugs, Devices, and the FDA:
Part 1: An Overview Of Approval Processes
For Drugs, JACC: Basical To Translational
Science, Vol. 1, Issue 3, pp. 170-179 (2016) . . . . . . . . . 5
vii
Cited Authorities
Page
Jenna Greene, Wait What? FDA Wants 55
Years To Process FOIA Requ est O ver
Vaccine Data, Reuters (Nov. 18, 2021) . . . . . . . . . . . . 6
Josh Blackman, The Irrepressible Myth of
Jacobson v. Massachusetts, forthcoming in
Buffalo L.R., Vol. 70 (Sept. 24, 2021 . . . . . . . . . . . . . 13
Josh Nathan-Kazis, Fauci Says ‘Tough To
Tell’ If COVID Boosters Will Be Needed
Every Year, Barron’s (Dec. 13, 2021) . . . . . . . . . . . . 21
Kimberly G. Blumenthal, et al., Acute Allergic
Reactions To mRNA COVID-19 Vaccines,
JAMA [Research Letter] (Mar. 8, 2021) . . . . . . . . . . 7
Laurence H. Tribe, Lawrence v. Texas: The
“Fundamental Right” That Dare Not Speak
Its Name, 117 Harv. L. Rev. 1893 (2004) . . . . . . . . . 17
Michael H. Merson, The HIV-AIDS Pandemic at 25 –
The Global Response, N. Engl. J. Med. (2006) . . . . 14
Nisha Kurani, et al., COVID-19 Test Prices
An d Pa y m e n t Po li c y, Pet e r s on -K F F
(Apr. 28, 2021) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Paul Thacker, COVID-19: Researcher Blows
The Whistle On Data Integrity Issues In
Pfizer’s Vaccine Trial, BMJ (Nov. 2, 2021) . . . . . . . . 6
viii
Cited Authorities
Page
P r e s i d e n t Jo s e p h B i d e n , R e m a r k s B y
Presid ent Bid en On Fightin g The
COVID-19 Pandemic (Sept. 9, 2021) . . . . . . . . . . . . . 21
Ra ndy E. Ba r nett & Eva n Ber n ick, Th e
Privileges or Immunities Clause Abridged:
A Critique of Kurt Lash on the Fourteenth
Amendment, 95 Notre Dame L.R. 499 (2019) . . . . . 12
Second Joint Repor t , Public Health And
Medical Professionals For Transparency
v. Food And Drug Administration, Dkt.
4:21-cv-01058 (N.D.T.X. Nov. 15, 2021) . . . . . . . . . . . . 6
Wen W. Shen, State And Federal Authority To
Mandate COVID-19 Vaccination, Congressional
Research Service (Apr. 2, 2021) . . . . . . . . . . . . . . . . . 9
World Hea lth Organi zation, Coronavir us
Di sea se (COV ID-19): Her d Immunity,
Lockdowns, And COVID-19 (Dec. 31, 2020) . . . . . . 19
1
INTEREST OF AMICUS CURIAE1
We The Patriots USA, Inc. is a national, nonpartisan,
nonprofit membership charity dedicated to promoting
constitutional rights and other freedoms through
education, outreach, and public interest litigation, thereby
advancing religious freedom, medical freedom, parental
rights, and educational freedom for all. Many of its
members will be impacted by the Court’s decision.
SUMMARY OF THE ARGUMENT
The Respondents’ Emergency Temporary Standard
(ETS) constitutes the largest invasion of personal choice
and personal privacy in American history, and it violates
every American’s Fourteenth Amendment right to bodily
integrity and self-determination by functionally imposing
a COVID-19 vaccination mandate on them. Like most
COVID-19 public health regulations, the ETS relies heavily
on the Court’s precedent in Jacobson v. Massachusetts
as plenary authority to impose a nationwide vaccination
mandate in the interests of public health.
T he Cou r t ha s f u nd a ment a l ly r e shap ed it s
constitutional jurisprudence in the 116 years since it
decided Jacobson. It has developed a substantive due
process jurisprudence that established frameworks for
recognizing individual fundamental unenumerated rights
under the Fourteenth Amendment. It has also developed
tiers of constitutional scrutiny for both enumerated and
1. Under Rule 37, the amicus curiae give notice that no
party’s counsel authored any part of this brief, and no person or
entity other than amicus funded its preparation and submission.
2
unenumerated constitutional rights. Most importantly, it
has recognized an unenumerated right to bodily integrity
and self-determination under the Fourteenth Amendment,
specifically in refusing specific types of medical treatment.
Despite these developments, the Court’s jurisprudence
has not afforded consistent recognition or protection to
unenumerated constitutional rights. In particular, the
Court has not explicitly recognized certain unenumerated
rights as fundamental in a consistent fashion despite
descr ibing them in ter ms nor mally reser ved for
fundamental rights. It also has not given fundamental
unenumerated rights the benefit of strict scrutiny on a
consistent basis. The right to bodily integrity and self-
determination falls into this category.
Amicus urges the Court to take the opportunity to
unequivocally establish the right to bodily integrity and
self-determination as a fundamental unenumerated right
entitled to strict scrutiny and consider it in its analysis
of the major-questions issue submitted by the parties.
This consideration is both appropriate and sorely needed
because reasonable doubts exist as to the safety and
efficacy of the COVID-19 vaccinations and almost 25% of
Americans stand to lose their ability to provide the basic
necessities of life for themselves and their families simply
because they choose to exercise their constitutional rights
to refuse a specific medical treatment. Their plight and
their rights are appropriately considered as the Court
analyzes whether Congress should have addressed this
question because of its significance.
Amicus also urges the Court to reaffirm its precedents
that confine Congress’s commerce power to regulating
3
economic activity and do not permit it to regulate
noneconomic inactivity. Upholding the ETS would depart
drastically from the Court’s Commerce Clause precedents,
and such a decision would strip the states of their exclusive
power to regulate public health by creating an unparalleled
and unrestrained federal power to regulate public health.
The principles of federalism contained in the Constitution
do not permit such a departure.
ARGUMENT
The Respondents’ ETS purports to offer a choice
between COVID-19 vaccinations or weekly COVID-19
testing. See COVID-19 Vaccination and Testing;
Emergency Temporary Standard, 86 Fed. Reg. 61,402
(Nov. 5, 2021). The choice, however, is not really a choice
at all.
COVID-19 testing is expensive, and data shows that
the average cost for a COVID-19 test runs between $100-
$149. See Nisha Kurani, et al., COVID-19 Test Prices And
Payment Policy, Peterson-KFF (Apr. 28, 2021). 2 Someone
has to bear the weekly cost of COVID-19 testing. For
insurers and employers, bearing this cost would ultimately
drive them out of business due to losses. For the average
American employee living paycheck to paycheck, bearing
another $400-$600 expense per month simply does not
fit reality. Thus, the only realistic choice under the ETS
is for employers to mandate COVID-19 vaccinations as a
condition of employment and for employees to receive a
vaccination to maintain their ability to provide the basic
necessities of life for themselves and their families.
2. https://www.healthsystemtracker.org/brief/covid-19-test-
prices-and-payment-policy/
4
As the documents supporting the ETS reveal, this
Hobson’s choice reaches “two-thirds of all private-sector
workers,” 86 Fed. Reg. at 61,403, or over 25% of the
United States’ population, id. at 61,475. In other words,
ETS imposes a federal COVID-19 vaccination mandate
by default on a segment of the United States’ population,
which has foregone vaccination for personal reasons. Id.
at 61,553.
The Court’s precedents clearly establish a fundamental
principle. Individuals have a fundamental unenumerated
right under the Fourteenth Amendment to make their
own medical decisions. See, e.g., Cruzan by Cruzan v. Dir.,
Missouri Dep’t of Health, 497 U.S. 261 (1990). They also
establish the power to regulate noneconomic inactivity for
public health purposes belongs exclusively to the states.
I. There Are Serious Questions On Whether The
Risks Of COVID-19 Vaccinations Outweigh Their
Rewards.
No one disputes that the COVID-19 pandemic posed
an unknown and urgent public health danger in early 2020.
To an extent, it also caught the United States unprepared,
and public health officials scrambled to cope with a disease
that they did not fully understand. Thus, federal officials
decided that extraordinary times called for extraordinary
measures.
One of the extraordinary measures that U.S. Food &
Drug Administration (FDA) took was to issue emergency
use authorizations (EUAs) pursuant to 21 U.S.C.
§ 360bbb-3 for three vaccines specifically developed at
record speed to combat COVID-19: Pfizer, Moderna, and
5
Janssen. 3 Unlike the standard rigorous testing process
that the FDA employs to test the safety of new drugs
which averages 12 years from application to approval,4
EUAs issue immediately based on knowledged-based
risk assessments. In other words, the FDA weighs “the
known and potential benefits of the product…” against its
“known and potential risks…,” and it determines whether
a disease creates an emergency serious enough to justify
the immediate use of an untested product. 21 U.S.C. §
360bbb-3 (c)(2)(B).
In another acceleration of normal time frames, the
FDA then issued full approval to the Pfizer COVID-19
vaccination on August 23, 2021 – less than a year after it
first issued its EUA for the Pfizer vaccination. 5
While the haste to find vaccines to combat COVID-19
and make it available to the public is understandable, the
haste also drives serious concerns about the vaccines’
risks – both known and unknown – and how well the FDA
considered them. Given the knowledge-based risk/reward
assessment that the law required the FDA to perform
for the EUAs, a prudent citizen would not depart from
reason’s realm if he conducted the same assessment in
skepticism of the FDA’s conclusions.
3. https://w w w.fda.gov/emergency-preparedness-and-
response/coronavirus-disease-2019-covid-19/covid-19-vaccines
4. See Gail A. Van Norman, Drugs, Devices, and the FDA:
Part 1: An Overview Of Approval Processes For Drugs, JACC:
Basical To Translational Science, Vol. 1, Issue 3, pp. 170-179 (2016).
5. https://www.fda.gov/news-events/press-announcements/
fda-approves-first-covid-19-vaccine
6
Such skepticism is not baseless as two well-documented
incidents pertaining to the Pfizer vaccine demonstrate.
First, 21 C.F.R. § 601.51(e) requires the FDA to
immediately release “all safety and effectiveness data
and information” for newly approved drugs. The FDA
did not release this information immediately after, or
concurrent to, fully approving the Pfizer vaccine. Instead,
when respected doctors and scientists from renowned
institutions such as Yale University sought the information
through Freedom of Information Act (FOIA) requests,6
the FDA informed a federal district court that it could only
produce the information at a rate that would ultimately
require 55 years to fully produce the data.7
Second, at least one whistleblower made a corroborated
complaint that one of Pfizer’s testing contractors, Ventavia
Research Group, falsified data and ignored adverse
reactions to its COVID-19 vaccine while testing it. See
Paul Thacker, COVID-19: Researcher Blows The Whistle
On Data Integrity Issues In Pfizer’s Vaccine Trial, BMJ
(Nov. 2, 2021).8 She reported that the FDA never inspected
6. See Complaint, Public Health And Medical Professionals
For Transparency v. Food And Drug Administration, Dkt. 4:21-
cv-01058 (N.D.T.X. Sept. 16, 2021).
7. Second Joint Report, Public Health And Medical
Pr ofe s s i o n a l s Fo r Tr a n s p a r e n c y v . Fo o d An d D r u g
Administration, Dkt. 4:21-cv-01058 (N.D.T.X. Nov. 15, 2021); see
also Jenna Greene, Wait What? FDA Wants 55 Years To Process
FOIA Request Over Vaccine Data, Reuters (Nov. 18, 2021)Reuters
(Nov. 18, 2021. Retrieved from https://www.reuters.com/legal/
government/wait-what-fda-wants-55-years-process-foia-request-
over-vaccine-data-2021-11-18/
8. https://www.bmj.com/content/375/bmj.n2635
7
or audited the trial despite her reports and that Ventavia
fired her for blowing the whistle. Id.
The last self-audit that the FDA Inspector General
conducted does little to allay the concerns raised by
the whistleblower. In 2005, the FDA Inspector General
estimated that the FDA inspected approximately 1% of
clinical trial sites. See Daniel R. Levinson, The Food And
Drug Administration’s Oversight Of Clinical Trials, U.S.
Dept. Of Health And Human Services, Office of Inspector
General (Sept. 2007). 9 There is no indication that the
FDA’s hands-off approach to monitoring clinical trials has
changed, particularly as the world raced to find a solution
to the COVID-19 pandemic.
The FDA’s lack of transparency as to the Pfizer trial
data despite its legal obligations and firsthand accounts of
falsified data and misconduct during clinical trials raise
serious questions on whether the COVID-19 vaccinations
pose greater health risks than the federal government
is willing to acknowledge. There is fire beneath this
smoke. Private studies indicate that adverse reactions to
COVID-19 vaccines likely occur at a rate almost 100 times
higher than the Center for Disease Control and Prevention
(CDC) has reported. See Kimberly G. Blumenthal, et al.,
Acute Allergic Reactions To mRNA COVID-19 Vaccines,
JAMA [Research Letter] (Mar. 8, 2021) (reporting that
adverse reactions to COVID-19 vaccines occur at a rate
of 2.47 per 10,000 vaccinations compared to the CDC’s
estimate of 0.025-0.11 per 10,000 vaccinations).10
9. https://www.oig.hhs.gov/oei/reports/oei-01-06-00160.pdf
10. ht tp s: //ja ma net work .com /jou r na l s /ja ma /
fullarticle/2777417
8
Skepticism does not render someone anti-vaccine or
irresponsible. The haste in which the COVID-19 vaccines
have been developed should make any reasonbly prudent
person pause and carefully consider whether it is in the best
interests of their health to take a COVID-19 vaccination.
The FDA’s lack of transparency and apparent inability
to properly supervise clinical trials even when in receipt
of complaints of falsified data and hidden adverse events
further supports a healthy dose of skepticism. Finally,
the United States government’s own underreporting of
adverse reactions to COVID-19 vaccinations compels a
reasonably prudent person to make the same risks versus
rewards calculation that the FDA made in issuing EUAs
for the COVID-19 vaccines.
In other words, the facts do not support blind faith in
the FDA’s conclusions. They support searching inquiries
conducted by individuals and their doctors, and, when an
individual’s health and life is at stake, the facts support the
historical proposition that it is his sole right to make such
a deeply personal and important choice on what risks to
endure. As detailed below, the United States Constitution
protects this individualized choice against government
interference.
II. The ETS Violates The Major-Questions Doctrine
Because Mandating Medical Treatment For Vast
Portions Of The Population Is A Major Political
And Economic Question That Congress Has Never
Delegated To The Executive Branch Because It
Cannot Constitutionally Act Itself.
Employment-related vaccine mandates have already
come before the Court at least twice this year in the context
9
of eliminated religious exemptions. See We The Patriots
USA, Inc., et al. v. Hochul, et al., No. 21A125; Dr. A., et
al. v. Hochul, et al., No. 21A145; Does 1-3, et al. v. Mills,
No. 21A90. While the Court has denied these emergency
applications for relief with two justices implying that the
Court would benefit from more percolation in the lower
courts, see Mills, No. 21A90 (Oct. 29, 2021) (Barrett, J. and
Kavanaugh, J. concurring), the same underlying question
presents itself once again, albeit in a different format.
To what extent does the Constitution per mit
governments to police personal health decisions for public
health reasons?
In view of the ancient common law and constitutional
rights to medical freedom, achieving a constitutional
balance is a delicate task of tremendous political
significance. When the decision impacts over 80 million
Americans’ ability to provide the basis necessities of life
for themselves and their families, it also becomes a task
of tremendous economic significance.
The Court has clearly stated that it expects “Congress
to speak clearly when authorizing an agency to exercise
powers of vast economic and political significance.”
Alabama Ass’n of Realtors v. Dep’t of Health & Hum.
Servs., 141 S. Ct. 2485, 2489 (Aug. 26, 2021). Congress,
however, has never specifically authorized any agency
– including OSHA – to police personal health decisions
in the name of public health by imposing a vaccination
mandate on millions of Americans. See Wen W. Shen,
State And Federal Authority To Mandate COVID-19
Vaccination, Congressional Research Service, pp. 5-8
(Apr. 2, 2021). Instead, the single statutory provision
10
that the Respondents have pointed to in defense of their
new-found power to mandate vaccination is an exemption
provision, not an authorizing provision: “Nothing in this
or any other provision of this chapter shall be deemed to
authorize or require medical examination, immunization,
or treatment for those who object thereto on religious
grounds, except where such is necessary for the protection
of the health or safety of others.” 29 U.S.C. § 669(a)(5).
Congress’ silence has ostensibly reserved the question
for itself, and its inaction reflects the state of modern
constitutional jurisprudence. The Court’s development of
its substantive due process jurisprudence has rejected a
freewheeling public health exception to the Constitution
and recognized a fundamental unenumerated right to
medical freedom.
A. The Court has implicitly narrowed Jacobson
v. Massachusetts and rejected a public health
exception to the Fourteenth Amendment.
Throughout the COVID-19 pandemic and particularly
when it comes to vaccinations, the Court’s decision in
Jacobson v. Massachusetts, 197 U.S. 11 (1905) invariably
serves as the starting point and, for governments, the
ending point in any dispute on the constitutionality
of public health regulations. The Court, however, has
implicitly narrowed its scope over the past 100 years of
its jurisprudence.
Jacobson’s facts have become axiomatic to an
extent during the COVID-19 pandemic. Camrbidge,
Massachusetts faced a smallpox outbreak, and it decided
to cope with it by mandating smallpox vaccinations.
11
Jacobson, 197 U.S. at 12-13. Henning Jacobson declined
to receive a vaccination because it posed an undue risk to
his health, he had suffered greatly from a vaccine-caused
disease in his childhood, and his son had experienced
similar suffering. Id. at 23-24, 36. In response, the city
criminally prosecuted him, secured his conviction, and
imprisoned him until he paid a $5 fine. Id. at 13-14.
Jacobson appealed his conviction on the grounds that the
Fourteenth Amendment protected an “inherent right of
every freeman to care for his own body and health in such
way as to him seems best,” and he claimed that executing
the law on him was “nothing short of an assault upon
his person.” Id. at 26. The Court applied a deferential
standard of review akin to rational basis review and held
that Cambridge’s vaccination was reasonable and did not
offend any right secured by the Constitution. Id. at 38.
Jacobson, however, was a man ahead of his time. He
claimed a fundamental unenumerated right under the
Fourteenth Amendment just before the Court’s first foray
into unenumerated rights in Lochner v. New York, 198 U.S.
45 (1905) and well before the Court’s first substantive due
process recognition of unenumerated rights to “personal
liberties” in Meyer v. Nebraska, 262 U.S. 390 (1923). Thus,
the Court treated Jacobson’s claim of an inherent right to
care for his own body as a claim of generalized liberty and
applied its normal standard of deferential review.
The Court’s treatment of Jacobson’s claims tracks
its treatment of the Fourteenth Amendment up until
1905. Although the Fourteenth Amendment’s Framers
clearly expressed an intention to grant unenumerated
12
rights through its Privileges or Immunities Clause,11 the
Court declined to do so in The Slaughter-House Cases,
83 U.S. 36 (1873). When the Court ultimately recognized
unenumerated rights under its substantive due process
jurisprudence in Lochner, it did so in a freewheeling
generalized fashion. The Court finally brought order to
its treatment of unenumerated rights in United States
v. Carolene Products Co., 304 U.S. 144, 152 n. 4 (1938)
by establishing what we now recognize as modern
constitutional scrutiny doctrines. Even then, the Court
did not apply a form of scrutiny other than rational basis
review for six years after it outlined tiers of scrutiny in
Carolene Products Co. See Korematsu v. United States,
323 U.S. 214 (1944).
Despite these developments, the Court’s substantive
due process jurisprudence underwent another major shift
inspired by Justice Harlan’s concurrence in Griswold
v. Connecticut, 381 U.S. 479 (1965). Justice Harlan’s
concurrence suggested that the Court ground its
substantive due process jurisprudence in “basic values
implicity in the concept of ordered liberty.” Griswold, 381
U.S. at 500 (Harlan, J., concurring) (internal quotation
marks and citations omitted). Under Harlan’s framework,
the Court began to recognize specific fundamental
unenumerated rights under its substantive due process
doctrine rather than applying foundational principles
case-by-case. See Cameron L. Atkinson, A General
Sovereign/Public Employer Distinction: Should Garcetti
v. Ceballos Govern Public Employment Cases Concerning
11. See Randy E. Barnett & Evan Bernick, The Privileges
or Immunities Clause Abridged: A Critique of Kurt Lash on the
Fourteenth Amendment, 95 Notre Dame L.R. 499, 500 (2019)
13
Off-Duty Sexual Conduct Instead of Lawrence v. Texas?
38 Quinnipiac L. Rev. 325, 333 (2020) (tracing early
recognitions of fundamental unenumerated rights as they
pertain to marriage). Harlan’s framework then required
the Court to develop a test for recognizing unenumerated
rights and determining which level of scrutiny to apply to
them, which it did in Washington v. Glucksberg, 521 U.S.
702 (1997) and possibly revised in Obergefell v. Hodges,
135 S.Ct. 2584 (2015). Id. at 333-35.
Within the Harlan framework, the Court issued three
decisions that significantly narrowed Jacobson. First,
in 1973, it held that a woman possesses a fundamental
unenumerated constitutional right to privacy in deciding
whether to have an abortion. Roe v. Wade, 410 U.S. 113, 154
(1973). While the Court cited Jacobson for the proposition
that a woman’s right to privacy in her decision to obtain
an abortion was not unlimited, it abandoned Jacobson’s
deference to public health policy decisions and held
that Texas’s public health poplicy choice – life begins at
conception – could not avoid strict scrutiny analysis when
it regulated a woman’s right to get an abortion.12 Id. at 162.
Thus, the Court discarded Jacobson’s deference to public
health policy decisions in favor of a far more stringent
analysis when a fundamental unenumerated constitutional
right was at stake.
Second, in 1992, the Court held that its “cases
since Roe accord with Roe’s view that a State’s interest
12. See Josh Blackman, The Irrepressible Myth of Jacobson
v. Massachusetts, forthcoming in Buffalo L.R., Vol. 70, pp. 59-66
(Sept. 24, 2021) (discussing Roe’s inconsistency with Jacobson).
Professor Blackman’s article is available at https://papers.ssrn.
com/sol3/papers.cfm?abstract_id=3906452
14
in the protection of life falls short of justifying any
plenary override of individual liberty claims.” Planned
Parenthood v. Casey, 505 U.S. 833, 857 (1992). Casey’s
reiteration of Roe’s treatment of Jacobson even more
clearly narrows Jacobson’s impact within the Court’s
modern constitutional jurisprudence by eliminating its
role as an escape hatch for public health regulations to
avoid ordinary constitutional scrutiny.
Third, the Court remained silent about Jacobson
in Lawrence v. Texas, 539 U.S. 558 (2003). The CDC
described HIV/AIDS as a global pandemic in 2006,13 and
it was treated as a global pandemic since the 1980s.14
According the CDC’s 2008 statistics, gay and bisexual
men accounted for 69% of new HIV diagnoses.15 Despite
HIV/AIDS being declared a global pandemic and the
increased risk of the spread of HIV/AIDS among gays and
bisexuals, the Court clearly established that states’ police
power does not permit them to criminalize homosexual
intimacy. Lawrence, 539 U.S. at 578. In doing so, the
Court used language that intimated its recognition of a
fundamental unenumerated right to engage in homosexual
relationships, but it applied rational basis review. See
Atkinson, 38 Quinnipiac L. Rev. at 338-339 (discussing the
confusion created by Lawrence’s apparent recognition of
a fundamental unenumerated right, but its application of
13. https://w w w.cdc.gov/mmw r/prev iew/mmw rhtml /
mm5531a1.htm
14. Michael H. Merson, The HIV-AIDS Pandemic at 25 – The
Global Response, N. Engl. J. Med. (2006). https://www.nejm.org/
doi/full/10.1056/nejmp068074
15. https://www.cdc.gov/hiv/statistics/overview/ataglance.
html
15
rational basis scrutiny). Neither Jacobson or its progeny
made an appearance in Lawrence, but the Court narrowed
Jacobson significantly by requiring states to demonstrate
harm “specific to an individual,” thus implying that
“generalized state interest[s] in public health concerns”
are not enough to overcome the protection afforded
to unenumerated rights protected by the Fourteenth
Amendment. Id. at 355.
Thus, this history and Roe, Casey, and Lawrence
stand for an unmstakable proposition. Jacobson did
not create a “plenary override” or an escape valve for a
public health regulation to escape strict constitutional
scrutiny when it burdens a fundamental unenumerated
constitutional right.
B. The Court’s precedents establish an individual’s
fundamental unenumerated right under the
Fourteenth Amendment to make their own
medical decisions.
In 1891, the Court recognized the common law’s
historical reverence for bodily integrity and self-
determination as legal rights: “No right is held more
sacred, or is more carefully guarded by the common
law, than the right of every individual to the possession
and control of his own person, free from all restraint or
interference of others, unless by clear and unquestionable
authority of law.” Union Pac. R. Co. v. Botsford, 141
U.S. 250, 251 (1891); see also Cruzan by Cruzan v. Dir.,
Missouri Dep’t of Health, 497 U.S. 261, 269-270 (1990).
It then inferred its constitutional status in 1990: “The
principle that a competent person has a constitutionally
protected liberty interest in refusing unwanted medical
16
treatment may be inferred from our prior decisions.”
Cruzan, 497 U.S. at 278 (citing Jacobson, 197 U.S. at 24-
30); see also Washington v. Harper, 494 U.S. 210, 221-222
(1990).
Like Lawrence, however, the Court has not afforded
the constitutional rights to bodily integrity and self-
determination the protection of strict scrutiny despite
describing them in terms characteristic of fundamental
unenumerated rights. Cruzan, 497 U.S. at 278; Harper,
494 U.S. at 221-222. Instead, the Court has employed an
ambiguous balancing test akin to Jacobson’s deferential
rational basis standard. Cruzan, 497 U.S. at 279 (“whether
respondent’s constitutional rights have been violated must
be determined by balancing his liberty interests against
the relevant state interests”).
This deferential test has rendered the Court’s bodily
integrity and self-determination jurisprudence just as
standardless and freewheeling as its repudiated Lochner
jurisprudence was.
For example, compa re the Cou r t’s lang uage
recognizing a constitutional right to abortion as a
fundamental constitutional right and its language
recognizing bodily integrity and self-determination as
rights. The Court described a woman’s decision on whether
to terminate a pregnancy as one of the “most intimate and
personal choices that a person may make in a lifetime,
choices central to personal dignity and autonomy.” Casey,
505 U.S. at 851. It described a person’s right to decline
medical treatment: “[n]o right is held more sacred, or
is more carefully guarded by the common law, than the
right of every individual to the possession and control of
17
his own person, free from all restraint or interference of
others, unless by clear and unquestionable authority of
law.” Botsford, 141 U.S. at 251; Cruzan, 497 U.S. at 269-
270 (same).
The Court’s description of the rights to bodily
integrity and self-determination is at least equally strong
as its description of abortion, and a reasonable jurist
could even argue that its description of bodily integrity
and self-determination is stronger than its description of
the right to an abortion. The Court, however, has applied
strict scrutiny to examine state regulations of the right
to an abortion – Roe, 410 U.S. at 154-56 – while employing
a deferential and ambiguous balancing test to the rights
to bodily integrity and self-determination. Cruzan, 497
U.S. at 279.
It requires too much from scholars, jurists, and
lawyers to build a legal distinction between the Court’s
treatment of the two rights.16 For abortion, the Court
requires a state actor to satisfy strict scrutiny even when it
has decided that the act of abortion is the actual intentional
killing of another human being. For declining medical
treatment, the Court defers to a state actor’s decision that
someone may infect another person with a disease that he
possibly might die from and employs a unique balancing
test that almost always favors the state’s interests.
16. Nor is the confusion confined to these two rights in
particular. The Court caused similar confusion in Lawrence
v. Texas. See generally Atkinson, 38 Quinnipiac L. Rev. 325;
Laurence H. Tribe, Lawrence v. Texas: The “Fundamental Right”
That Dare Not Speak Its Name, 117 Harv. L. Rev. 1893 (2004).
18
Lochner - esqe, f reewheel ing substantive due
process jurisprudence of this nature gives protection
to fundamental constitutional rights based on the
idiosyncratic values of the Court’s justices. The rights
secured by the Constitution do not ebb and flow with
the preferences of the Court’s members. The Court
should take the opportunity to bring consistency to its
substantive due process jurisprudence in this case, and
it should begin by reaffirming its prior statements on
the importance of the rights to bodily integrity and self-
determination, declaring the rights to bodily integrity
and self-determination fundamental unenumerated rights
under the Fourteenth Amendment, and requiring the
Respondents to satisfy strict scrutiny with respect to
the ETS.
C. The ETS targets individuals who exercise their
right to make personal medical decisions that
contradict the federal government’s public
health recommendations.
Transparency has been a major issue for many
Americans when it comes to their personal decisions
about whether to get a COVID-19 vaccination. Besides
the direct concerns about the COVID-19 vaccinations
discussed previously, the nation’s leaders have struggled
to offer definite answers and have confessed to amending
their answers for political purposes. It should come as no
surprise that they have not inspired trust and confidence
in their advocacy for people to get vaccinated.
There is no shortage of such incidents.
19
First, almost every known infectious disease that
the world combats by vaccination becomes nearly extinct
once a population reaches herd immunity – “the indirect
protection from an infectious disease that happens when
a population is immune either through vaccination or
immunity developed through previous infection.” World
Health Organization, Coronavirus Disease (COVID-19):
Herd Immunity, Lockdowns, And COVID-19 (Dec. 31,
2020)17 In December 2020, The World Health Organization
(WHO) stated that no studies have effectively established
what percentage of a population must become vaccinated
to reach herd immunity against COVID-19, but pointed
to herd immunity against measles as requiring 95% of a
population to be vaccinated and polio requiring 80%. Id.
Dr. A nthony Fauci – the exper t leading the
Respondents’ response to COVID-19 – also attempted
to establish a number for herd immunity. Dr. Fauci’s
numbers, however, kept changing. When the pandemic
began, Dr. Fauci consistently told the United States that
it needed to achieve a 60-70% herd immunity threshold.
See Donald G. McNeil, Jr., How Much Herd Immunity
Is Enough? New York Times (Dec. 24, 2020) (reporting
Dr. Fauci’s previous public statements and interviewing
him).18 At the end of 2020, he gradually increased his
prognostication until he reached 85%. Id. At the same
time that he moved his prognostications up, Dr. Fauci
practically staked his fortune on the fact that COVID-19
would not require the same herd immunity threshold as
17. https://w w w.who.int /news-room /q-a-detail / herd-
immunity-lockdowns-and-covid-19
18. https://w w w.nytimes.com/2020/12/24/health/herd-
immunity-covid-coronavirus.html
20
measles: “I’d bet my house that Covid isn’t as contagious
as measles.” Id.
Had Dr. Fauci left his comments there, a reasonable
reader could have concluded that he simply made a
scientific error as he sought to cope with an unknown
disease like the rest of the world. Dr. Fauci, however,
made a stunning confession that he adjusted his numbers
for political reasons: “When polls said only about half of
all Americans would take a vaccine, I was saying herd
immunity would take 70 to 75 percent…. Then, when newer
surveys said 60 percent or more would take it, I thought,
‘I can nudge this up a bit,’ so I went to 80, 85.” Id.
Second, Dr. Fauci then attempted to place himself and
his government colleagues beyond legislative and popular
criticism. In a MSNBC interview, Dr. Fauci declared that
“[a]ttacks on me, quite frankly, are attacks on science….
All of the things I have spoken about, consistently, from
the very beginning, have been fundamentally based on
science. Sometimes those things were inconvenient truths
for people.” See Carlie Porterfield, Dr. Fauci On GOP
Criticism: “Attacks On Me, Quite Frankly, Are Attacks
On Science,” Forbes.com (Jun. 9, 2021).19
Third, the United States – along with international
and state governments – promised that COVID-19
vaccinations would chart a course to return life to normal
one day. New variants of COVID-19 have emerged
regularly, and officials, including Dr. Fauci, have left the
19. https: // w w w.forbes.com /sit es /ca rl iepor t er f ield /
2021/06/09/fauci-on-gop-criticism-attacks-on-me-quite-frankly-
are-attacks-on-science/
21
door open on whether additional COVID-19 booster shots
will be necessary. See Josh Nathan-Kazis, Fauci Says
‘Tough To Tell’ If COVID Boosters Will Be Needed Every
Year, Barron’s (Dec. 13, 2021). 20
Combined with the concerns discussed above about the
safety of the COVID-19 vaccinations, these three elements
have created a complete lack of trust in the United States’
leaders among a large portion of the American population,
and they have raised reasonable skepticism on whether the
COVID-19 vaccines are actually effective enough to justify
their risks. Rather than work in a straightforward manner
to regain Americans’ trust, Dr. Fauci and his colleauges
have claimed that they are above criticism and skepticism
– claims that have only solidified reasonable people in
their concerns about the Respondents’ recommendations.
Thus, “frustrated with the nearly 80 million Americans
who are still not vaccinated…” and have chosen to
exercise their constitutional rights to decline the medical
treatment of vaccination, the Respondents have abandoned
persuasion and turned to coercion. See President Joseph
Biden, Remarks By President Biden On Fighting The
COVID-19 Pandemic (Sept. 9, 2021). The coercion that
they have chosen is to draw a line of demarcation via the
ETS between the vaccinated and the unvaccinated and
to saddle qualified employers with such severe hardships
as to compel them to require their employees to become
vaccinated.
20. https://w w w.barrons.com /articles/covid-booster-
omicron-anthony-fauci-51639401295
22
For an A merican who chooses to exercise his
constitutional right to refuse this medical treatment, the
consequences are devastating. The ETS functionally bars
him from working for almost any medium-to-large-sized
business in the United States, essentially foreclosing
countless job opportunities and leaving him with virtually
no means to provide the basic necessities of life – food,
shelter, and clothing – for himself and his family. In other
words, the ETS outlaws from the American workforce the
citizens who have chosen a reasonable course of action
instead of blind faith, and it renders their continued
existence in society nearly untenable.
In terms of scale, the ETS represents the largest
invasion of personal freedom and privacy in American
history, affecting almost two-thirds of the American
economy and 25% of its population. Its imposition by
executive fiat instead of careful legislative deliberation
demonstrates a complete and utter regard for its political
and economic significance. Thus, the Court should hold,
in view of the individual constitutional rights at stake and
the ETS’ devastating consequences, that the Respondents
have violated the major-questions doctrine, and it should
offer clear guidance to Congress that any action that it
takes on this question must satisfy strict scrutiny if it
regulates the individual rights to bodily integrity and
self-determination.
III. Federalism Prohibits Congress From Exercising
Police Power To Enact General Measures To
Protect Public Health.
Congress’s power to regulate workplace conditions
comes from the Commerce Clause. Despite the breadth
23
of Congress’s power to regulate commerce, the Court
has long held that that the states did not surrender the
power to police public health to the federal government,
and it enumerated certain powers that are off-limits to
Congress: “Inspection laws, quarantine laws, health laws
of every description, as well as laws for regulating the
internal commerce of a State, and those which respect
turnpike roads, ferries…. No direct general power over
these objects is granted to Congress; and, consequently,
they remain subject to State legislation.” Gibbons v.
Ogden, 22 U.S. 1, 203 (1824).
Federalism requires this approach even when core
state functions have substantial effects on interstate
commcerce. See, e.g., United States v. Morrison, 529
U.S. 598, 615 (2000) (striking down the civil enforcement
of the Violence Against Women Act because it regulated
gender-motivated violence regardless of whether it
crossed state lines or occurred through an instrumentality
of interstate commerce); United States v. Lopez, 514
U.S. 549, 565, 577 (1995) (striking down a federal law
criminalizing the possession of guns near schools because
it opened the door for Congress to regulate every aspect
of schools, including their curriculums). Critical to the
Court’s reasoning in Lopez and Morrison was the fact
that Congress attempted to regulate conduct that was
not economic in nature. Lopez, 514 U.S. at 551 (“The Act
neither regulates a commercial activity nor contains a
requirement that the possession be connected in any way
to interstate commerce”); Morrison, 529 U.S. at 610-612
(same). Thus, Gibbons, Lopez, and Morrison establish
that Congress cannot regulate a noneconomic activity
unconnected to interstate commerce without exceeding
its Commerce Clause powers in violation of federalism
24
even when that activity substantially affects interstate
commerce. Morrison, 529 U.S. at 614.
These cases do not contradict the Court’s decisions
in Wickard v. Filburn, 317 U.S. 111 (1942) or Gonzalez
v. Raich, 545 U.S. 1 (2005). In Wickard, the Court
upheld a federal regulation establishing a wheat quota
as applied to a farmer’s excess growth solely for his own
personal use. 317 U.S. at 127-28. In Raich, the Court
upheld Congress’s authority to prohibit the home growth
of marijuana for personal consumption. 545 U.S. at 33.
As the Court explained in Raich, both cases concerned
economic activity under its adoption of Webster’s Third
New International Dictionary’s definition of “economics:”
“Economics refers to the production, distribution, and
consumption of commodities.” Id. at 25-26 (internal
quotation marks omitted). Because both cases involved the
production and consumption of a specific commodity and
substantially affected interstate commerce, the regulated
activity was economic, placing them within Congress’s
power to regulate.
The ETS does not regulate activity that meets Raich’s
definition of economic activity, and, unlike other OSHA
regulations, it does not regulate a commodity such as a
manmade chemical that can inadvertantly be consumed.
Instead, the ETS attempts to regulate a disease, not a
commodity, by regulating noneconomic inactivity through
the imposition of a public health law – a power that this
Court has long held that only the states hold. Gibbons, 22
U.S. at 203. An individual’s refusal to receive a COVID-19
vaccine or submit to testing is noneconomic inactivity
similar to the inactivity that the Court held to be beyond
Congress’s commerce power in N.F.I.B. v. Sebelius, 567
25
U.S. 519, 555–58 (2012) (opinion of Roberts, C.J.) (“Any
police power to regulate individuals[‘s] [inactivity], as
opposed to their activities, remains vested in the States”).
Departing from the Court’s precedents now would
open the door to federal public health regulation on an
unparalleled level. Just in the context of the COVID-19
pandemic, Congress would gain the power to control
lockdowns, quarantines, and masking rules simply
by claiming that they substantially affect interstate
commerce. It would also potentially gain the power to
mandate measures such as regular exercise and regular
doctor’s visits. Implementing what the public health
doctor orders does not lie within Congress’s power. The
Court should reject this invitation to expand Congress’s
commerce power to include public health measures.
CONCLUSION
For these reasons, amicus urges the Court to grant
the Applicants’ request for injunctive relief and their
petition for a writ of certiorari before judgment. It also
urges the Court to unequivocally recognize the individual
rights to bodily integrity and self-determination as
fundamental unenumerated rights protected by the
Fourteenth Amendment and deserving of strict scrutiny.
It also urges the Court to reaffirm its Commerce Clause
precedents that prohibit Congress from regulating
noneconomic inactivty.
26
Respectfully submitted,
Norman A. Pattis
Counsel of Record
Cameron L. Atkinson
Pattis & Smith, LLC
383 Orange Street, 1st Floor
New Haven, Connecticut 06511
(203) 393-3017
npattis@pattisandsmith.com
Counsel for Amicus Curiae
December 30, 2021
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