Court filing
21A244 024 Dec 29 2021 Main Document 20211229144437004 No 21A244 And 21A247 National Feder - Scotus
Full text
Nos. 21A244 and 21A247
IN THE
Supreme Court of the United States
d
IN RE : MCP NO . 165, OCCUPATIONAL SAFETY AND HEALTH
ADMINISTRATION , INTERIM FINAL RULE : COVID-19
VACCINATION AND TESTING ; EMERGENCY TEMPORARY STANDARD
86 FED . REG . 61402, ISSUED ON NOVEMBER 4, 2021
(Caption continued on inside cover)
ON EMERGENCY APPLICATIONS FOR STAY OF AGENCY STANDARD PENDING
THE DISPOSITION BY THE UNITED STATES COURT OF APPEALS FOR THE SIXTH
CIRCUIT OF A PETITION FOR REVIEW AND ANY FURTHER PROCEEDINGS IN
THIS COURT OR, ALTERNATIVELY, PETITION FOR A WRIT OF CERTIORARI
BEFORE JUDGMENT AND STAY PENDING RESOLUTION
MOTION OF DEFENDING THE REPUBLIC, INC. FOR
LEAVE TO FILE ATTACHED AMICUS BRIEF IN
SUPPORT OF EMERGENCY APPLICATIONS FOR A STAY
OR INJUNCTION PENDING CERTIORARI AND FOR
LEAVE TO FILE WITHOUT 10 DAYS NOTICE
HOWARD KLEINHENDLER
Counsel of Record
HOWARD KLEINHENDLER
ESQUIRE
369 Lexington Avenue,
12th Floor
New York, New York 10017
(917) 793-1188
howard@kleinhendler.com
Of Counsel: SIDNEY POWELL
BRANDON JOHNSON S IDNEY POWELL , P.C.
TRAVIS MILLER 2911 Turtle Creek Boulevard,
DEFENDING THE REPUBLIC , INC . Suite 300
2911 Turtle Creek Boulevard, Dallas, Texas 75219
Suite 300 (214) 707-1775
Dallas, Texas 75219 Counsel for Movant/Proposed
Amicus Defending
December 29th, 2021 The Republic, Inc.
NATIONAL FEDERATION OF INDEPENDENT BUSINESS, ET AL.,
Applicants,
—v.—
DEPARTMENT OF LABOR, OCCUPATIONAL SAFETY
AND HEALTH ADMINISTRATION , ET AL .,
Respondents.
STATE OF OHIO, ET AL.,
Applicants,
—v.—
DEPARTMENT OF LABOR, OCCUPATIONAL SAFETY
AND HEALTH ADMINISTRATION , ET AL .,
Respondents.
1
Amicus Defending The Republic, Inc. (“DTR”)
requests leave to file the attached amicus curiae brief
in support of the Emergency Applications, filed on
December 17–18, 2021, seeking a stay or injunction
pending certiorari to review the Sixth Circuit’s
decision granting a motion to dissolve a stay of the
Occupational Safety and Health Administration
(OSHA) Emergency Testing Standard on COVID-19
vaccination and testing. The Fifth Circuit entered a
stay before the matter was transferred to the Sixth
Circuit. Amicus further moves for leave to file the
attached brief without 10 days advance notice to the
parties. See Sup. Ct. R. 37.2(a).
By email on December 24, 2021, amicus provided
notice to the parties in 21A244 and 21A247 of its
intent to file an amicus brief in support of the
emergency applications. Counsel for the petitioners-
applicants the National Federation of Independent
Businesses in 21A244 stated that he does not oppose
the filing. Counsel for the State petitioners in 21A247
stated that he consents to the filing. Counsel for the
respondent U.S. Department of Labor takes no
position. Respondent’s briefs are due December 30.
Replies are due January 3. Oral argument is set for
January 7.
Amicus DTR is a nonprofit organization that is
dedicated to defending the Constitution, the rule of
law, and protecting individual rights of Americans
including medical freedom and religious liberty. DTR
represents over thirty military service members in
litigation involving the violation of their religious
freedoms and their other constitutional and statutory
rights to refuse mandatory vaccination with
experimental COVID-19 treatments. DTR also expects
to file suit soon to challenge the federal contractor
vaccine mandate on behalf of individual federal
2
contractors on similar grounds that have led multiple
federal district courts to impose a nation-wide
injunction and stay.
The COVID-19 vaccine mandate at issue in this
case is contrary to the mission and values of DTR. It
will subject tens of millions of Americans to an
unprecedented federal seizure of power, threatening
this nation’s Constitutional system of federalism. It
contradicts and violates existing laws and individual
rights to make health care decisions, and it violates
this Court’s long-standing recognitions of rights to
privacy.
In consideration of these interests, DTR seeks to
inform the Court that the Pfizer COVID-19 vaccine
mandated by the OSHA ETS and described as being
the one approved by the FDA, i.e., Comirnaty, is not
currently available to anyone in the United States.
The United States finally and reluctantly conceded
this in a lawsuit DTR brought in Florida. There is no
supply of Comirnaty. The only vaccines in production
and available are the vaccines approved under the
FDA’s Emergency Use Authorization (“EUA”). DTR
files this brief to explain why the OSHA COVID-19
vaccine mandate before the Court is an illegal federal
mandate to compel Americans to take an experimental
vaccine.
No counsel for any party authored the proposed
brief in whole or in part, and no person or entity, other
than the amicus curiae or its undersigned counsel,
contributed money intended to fund preparing or
submitting this brief.
3
CONCLUSION
Because no party has opposed the instant filing,
amicus requests that the Court grant leave to file the
attached amicus brief without 10 days advance notice
to the parties.
Respectfully submitted,
/s/ Howard Kleinhendler
HOWARD KLEINHENDLER
Counsel of Record
HOWARD KLEINHENDLER ESQUIRE
369 Lexington Avenue, 12th Floor
New York, New York 10017
(917) 793-1188
howard@kleinhendler.com
SIDNEY POWELL
SIDNEY POWELL, P.C.
2911 Turtle Creek Blvd., Suite 300
Dallas, Texas 75219
(214) 707-1775
sidney@federalappeals.com
Counsel for Movant/Proposed Amicus
Defending The Republic, Inc.
December 29, 2021
Nos. 21A244 and 21A247
IN THE
Supreme Court of the United States
d
IN RE : MCP NO . 165, OCCUPATIONAL SAFETY AND HEALTH
ADMINISTRATION , INTERIM FINAL RULE : COVID-19
VACCINATION AND TESTING ; EMERGENCY TEMPORARY STANDARD
86 FED . REG . 61402, ISSUED ON NOVEMBER 4, 2021
(Caption continued on inside cover)
ON EMERGENCY APPLICATIONS FOR STAY OF AGENCY STANDARD PENDING
THE DISPOSITION BY THE UNITED STATES COURT OF APPEALS FOR THE SIXTH
CIRCUIT OF A PETITION FOR REVIEW AND ANY FURTHER PROCEEDINGS IN
THIS COURT OR, ALTERNATIVELY, PETITION FOR A WRIT OF CERTIORARI
BEFORE JUDGMENT AND STAY PENDING RESOLUTION
[PROPOSED] BRIEF OF AMICI CURIAE
DEFENDING THE REPUBLIC, INC. IN SUPPORT OF
EMERGENCY APPLICATIONS FOR A STAY
OR INJUNCTION PENDING CERTIORARI
HOWARD KLEINHENDLER
Counsel of Record
HOWARD KLEINHENDLER
ESQUIRE
369 Lexington Avenue,
12th Floor
New York, New York 10017
(917) 793-1188
howard@kleinhendler.com
SIDNEY POWELL
SIDNEY POWELL , P.C.
Of Counsel: 2911 Turtle Creek Boulevard,
BRANDON JOHNSON Suite 300
TRAVIS MILLER Dallas, Texas 75219
DEFENDING THE REPUBLIC , INC . (214) 707-1775
2911 Turtle Creek Boulevard, Counsel for Movant/Proposed
Suite 300 Amicus Defending
Dallas, Texas 75219 The Republic, Inc.
NATIONAL FEDERATION OF INDEPENDENT BUSINESS, ET AL.,
Applicants,
—v.—
DEPARTMENT OF LABOR, OCCUPATIONAL SAFETY
AND HEALTH ADMINISTRATION , ET AL .,
Respondents.
STATE OF OHIO, ET AL.,
Applicants,
—v.—
DEPARTMENT OF LABOR, OCCUPATIONAL SAFETY
AND HEALTH ADMINISTRATION , ET AL .,
Respondents.
i
CORPORATE DISCLOSURE STATEMENT
Defending the Republic (“DTR”) is a 501(c)(4) not-
for-profit corporation organized under the laws of
Texas. It has no corporate parents or affiliates, nor
has it issued shares or securities.
ii
TABLE OF CONTENTS
PAGE
CORPORATE DISCLOSURE STATEMENT . . . . . . . i
TABLE OF AUTHORITIES . . . . . . . . . . . . . . . . . . . . . . iii
STATEMENT OF INTEREST. . . . . . . . . . . . . . . . . . . . . 1
SUMMARY OF THE ARGUMENT . . . . . . . . . . . . . . . . 2
ARGUMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
I. The Development of COVID-19
Vaccines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
II. The FDA-Approved Comirnaty is
Unavailable to the American Public . . . . . . . . 7
III. Important Differences Between EUA and
FDA-Approved Vaccines . . . . . . . . . . . . . . . . . . 11
A. The Right to Refuse an EUA Vaccine . . . 13
B. OSHA Cannot Override Informed
Consent Rights . . . . . . . . . . . . . . . . . . . . . . . 14
IV. EUA and FDA Licensed Products do not
have the “Same Formulation” and are not
“Interchangeable” . . . . . . . . . . . . . . . . . . . . . . . . 15
CONCLUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
iii
TABLE OF AUTHORITIES
PAGE(S)
Cases
Adullahi v. Pfizer, Inc.,
562 F.3d 163 (2d Cir. 2009) . . . . . . . . . . . . . . . . . . . 14
Alabama Assn. of Realtors v. Department of
Health and Human Services,
594 U.S. __, 2021 U.S. LEXIS 3679
(Aug. 26, 2021) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Coker v. Austin,
No. 3:21-cv-1211 (N.D. Fla.) . . . . . . . . . . . . . . . . . 3, 16
Crosby v. Austin,
8:21-cv-2730 (M.D. Fla.) . . . . . . . . . . . . . . . . . 3, 9, 16
DHS v. Regents of the Univ. of Cal.,
140 S.Ct. 1891 (2020) . . . . . . . . . . . . . . . . . . . . . . . . . 18
Doe v. Austin,
2021 WL 5816632 . . . . . . . . . . . . . . . . . . . . . . 9, 16, 17
Doe No. 1 v. Rumsfeld,
297 F.Supp.2d 119 (D.D.C. 2003) . . . . . . . . . . . . . . 15
John Doe #1 v. Rumsfeld,
341 F. Supp. 2d 1 (D.D.C. 2004), modified
2005 WL 774857 (D.D.C. 2005) . . . . . . . . . . . . . . 3, 15
In re MCP No. 165,
--- F.4th --- (2021), 2021 WL5989357
(6th Cir. Dec. 17, 2021) . . . . . . . . . . . . . . . . . . . . . 2, 11
SEC v. Chenery,
318 U.S. 80 (1943). . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
iv
PAGE(S)
Statutes
10 U.S.C. § 1107 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
10 U.S.C. § 1107a . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
21 U.S.C. § 360bbb-3 . . . . . . . . . . . . . . . . . . . . . . . . . . . 4, 6
21 U.S.C. § 360bbb-3(b)(1) . . . . . . . . . . . . . . . . . . . . . . . 11
21 U.S.C. § 360bbb-3(c)(2)(A) . . . . . . . . . . . . . . . . . . . . . 12
21 U.S.C. § 360bbb-3(c)(2)(B) . . . . . . . . . . . . . . . . . . . . . 13
21 U.S.C. § 360bbb-3(c)(3) . . . . . . . . . . . . . . . . . . . . . . . 12
21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III) . . . . . . . . . . . . 4, 13
21 U.S.C. § 564(e)(1)(A)(ii)(III) . . . . . . . . . . . . . . . . . . . 13
42 U.S.C. § 262, Public Health Service Act
Section 351 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17, 18
42 U.S.C. § 262(a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
42 U.S.C. § 262(k) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Regulations
21 C.F.R. § 50.20 (2008) . . . . . . . . . . . . . . . . . . . . . . . . . 14
21 C.F.R. § 50.23-.25 (2008) . . . . . . . . . . . . . . . . . . . . . . 14
21 C.F.R. § 50.27 (2008) . . . . . . . . . . . . . . . . . . . . . . . . . 14
21 C.F.R. § 312.20 (2008) . . . . . . . . . . . . . . . . . . . . . . . . 14
21 C.F.R. § 312.120 (2008) . . . . . . . . . . . . . . . . . . . . . . . 14
29 C.F.R. § 1910.1030(f) . . . . . . . . . . . . . . . . . . . . . . . . . 11
45 C.F.R. § 46.111 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
v
PAGE(S)
45 C.F.R. § 46.116-117 . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
85 Fed. Reg. 18,250 (April 1, 2020) . . . . . . . . . . . . . . . . 6
86 Fed. Reg. 61,402 (Nov. 5, 2021),
OSHA, COVID-19 Vaccination and Testing:
Emergency Temporary Standard . . . . . . . . . passim
86 Fed. Reg. 61,479 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
86 Fed. Reg. 61,532 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Rules
Rule 37.6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Other Authorities
CDC, Epidemiology and Prevention of Vaccine-
Preventable Diseases, available at:
https://www.cdc.gov/vaccines/pubs/pinkbook/
hepb.html . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
CDC, COVID-19 Vaccine Codes, available at:
https://www.cdc.gov/vaccines/programs/iis/
COVID-19-related-codes.html . . . . . . . . . . . . . . . . . . 8
CDC, Selected Adverse Events Reported After
COVID-19 Vaccination, available at:
https://www.cdc.gov/coronavirus/2019-
ncov/vaccines/safety/adverse-events.html . . . . . . . 3
CDC, Vaccines and Immunizations: Definition of
Terms, available at: http://web.archive.org/
web/20120710132002/https://www.cdc.gov/
vaccines/vac-gen/imz-basics.htm . . . . . . . . . . . . . . . 3
vi
PAGE(S)
CDC, Vaccines and Immunizations: Definition of
Terms (Aug. 26, 2021), available at:
http://web.archive.org/web/20210826113846/
https://www.cdc.gov/vaccines/vac-gen/imz-
basics.htm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Congressional Research Service, Operation Warp
Speed Contracts for COVID-19 Vaccines and
Ancillary Vaccination Materials (Mar. 1, 2021),
available at: https://crsreports.congress.gov/
product/pdf/IN/IN11560 . . . . . . . . . . . . . . . . . . . . . . . 5
FDA, Emergency Use Authorization for an
Unapproved Production Review Memorandum
(Janssen COVID-19 Vaccine) (Feb. 27, 2021)
available at: https://www.fda.gov/media/
146338/download . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
FDA, Emergency Use Authorization for an
Unapproved Product: Review Memorandum
(Moderna COVID-19 Vaccine) (Dec. 18, 2020),
available at: https://www.fda.gov/media/
144673/download . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
FDA, Emergency Use Authorization for an
Unapproved Product: Review Memorandum
(Pfizer-BioNTech COVID-19 Vaccine /
BNT162b2) (Nov. 20, 2020), available at:
https://www.fda.gov/media/
144416/download . . . . . . . . . . . . . . . . . . . . . . . . . . 6, 12
FDA, Ensuring the Safety of Vaccines in the
United States, last updated July 2011,
available at: https://www.fda.gov/files/
vaccines,%20blood%20&%20biologics/
published/Ensuring-the-Safety-of-Vaccines-
in-the-United-States.pdf . . . . . . . . . . . . . . . . . . . . . . 13
vii
PAGE(S)
FDA, Fact Sheet for Healthcare Providers
Administering Vaccine (Moderna COVID-19
Vaccine) (Revised Dec. 9, 2021), available at:
https://www.fda.gov/media/144637/
download . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
FDA, FDA Approves First COVID-19 Vaccine,
FDA Press Release (Aug. 23, 2021), available
at: https://www.fda.gov/news-events/press-
announcements/fda-approves-first-covid-19-
vaccine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
FDA, FDA Takes Key Action in Fight Against
COVID-19 by Issuing Emergency Use
Authorization for First COVID-19 Vaccine
(Dec. 11, 2020), available at:
https://www.fda.gov/news-events/press-
announcements/fda-takes-key-action-fight-
against-covid-19-issuing-emergency-use-
authorization-first-covid-19 . . . . . . . . . . . . . . . . . . . . 6
FDA, Pfizer-BioNTech EUA Letter
(Aug. 23, 2021) available at:
https://www.fda.gov/media/
150386/download . . . . . . . . . . . . . . . . . . . . . . . . . . 4, 16
FDA, Summary Basis of Regulatory Action –
Comirnaty (Nov. 8, 2021), available at:
https://www.fda.gov/media/151733/
download . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8, 16
NIH-Pfizer Announcement of Comirnaty
Unavailability (Sept. 13, 2021), available at:
https://www.cdc.gov/vaccines/programs/iis/
COVID-19-related-codes.html . . . . . . . . . . . . . . . . . . 8
Summary Basis of Regulatory Action, BLA
125742/0 (Aug. 23, 2021). . . . . . . . . . . . . . . . . . 15, 16
viii
PAGE(S)
Gail A. Van Norman, MD, Drugs, Devices and the
FDA: Part 1: An Overview of Approval
Processes for Drugs, JACC: Basic to
Translational Science, Apr. 2016 . . . . . . . . . . . . 7, 13
White House, Remarks by President Biden on
Fighting the COVID-19 Pandemic
(Sept. 9, 2021), available at:
https://www.whitehouse.gov/briefing-
room/speeches-remarks/2021/09/09/remarks-
by-president-biden-on-fighting-the-covid-19-
pandemic-3/ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Carl Zimmer, et al., Coronavirus Vaccine Tracker,
THE NEW YORK TIMES (last updated Dec. 22,
2021), available at: https://www.nytimes.com/
interactive/2020/science/coronavirus-vaccine-
tracker.html . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6, 7
1
STATEMENT OF INTEREST 1
DTR is dedicated to defending the Constitution,
the rule of law, and protecting individual rights of
Americans including medical freedom and religious
liberty. Currently, DTR represents over thirty military
service members in litigation challenging the
Department of Defense (“DOD”) vaccine mandate
because it violates service members’ constitutional
rights, religious freedoms, and their right to refuse
COVID-19 vaccines issued under an Emergency Use
Authorization (“EUA”). DTR will also be filing suits
challenging federal vaccine mandates for federal
contractors and federal employees in the near future.
The Occupational Safety and Health
Administration (“OSHA”) COVID-19 Emergency
Temporary Standard (“ETS”) at issue here2 is contrary
to the mission and values of DTR. It represents an
unprecedented federal usurpation of power,
threatening this nation’s Constitutional system of
federalism and violating individual rights. Further, it
is part of a larger wrongful system of federal mandates
that violate the rights of hundreds of millions of
American men, women, and children against being
required to take an experimental medical treatment as
a condition for employment, education, worship, or the
exercise of other constitutional rights.
1 In accordance with Rule 37.6, amicus curiae states that
no counsel for any party authored this brief in whole or in part,
and that no counsel or party, other than amicus curiae or
undersigned counsel, made a monetary contribution intended to
fund the preparation or submission of this brief
2 OSHA, COVID-19 Vaccination and Testing: Emergency
Temporary Standard, 86 Fed. Reg. 61,402 (Nov. 5, 2021) (“OSHA
Mandate” or “OSHA ETS”).
2
In consideration of these interests, DTR provides
the Court crucial information not addressed by
others.3 The government has conceded that the only
COVID-19 vaccine approved by the Food and Drug
Administration (“FDA”)—Pfizer-BioNTech’s Comirnaty—
is not available in the United States. The only
vaccines available are experimental products. DTR
files this brief to explain why the COVID-19 vaccine
mandate before the Court is really an unlawful federal
mandate to take an experimental vaccine.
SUMMARY OF THE ARGUMENT
A critical issue that has not been addressed in the
Applicants’ briefs, the OSHA Mandate, or the opinions
by the Fifth or Sixth Circuit Courts of Appeals, is that
OSHA and other federal agencies are mandating the
administration of an experimental product that has
not been approved by the FDA.4 In fact, none of the
approved “vaccine” is available in the United States.
3 DTR supports Applicants’ arguments that the OSHA
Mandate exceeds OSHA’s authority for the reasons set forth in
their briefs and will not repeat those arguments here. DTR’s
arguments are solely focused on bringing to the Court’s attention
the unavailability of FDA-licensed vaccine (i.e., Comirnaty), and
the implications a vaccine mandate may have for any federal or
state vaccine mandates.
4 The experimental status of the available COVID-19
vaccines undermines the Sixth Circuit’s decision because the
court was not informed that Comirnaty is unavailable. This was
critical to its reasoning which held that “OSHA acted within its
discretion in making the practical decision to wait for [FDA]
approval before issuing the ETS,” and found that such approval
“support[ed] OSHA’s conclusion that the current situation is an
emergency, and one that can be ameliorated by FDA action.” In
re MCP No. 165, --- F.4th --- (2021), 2021 WL 5989357, at *9 (6th
3
DTR urges the Court to grant Applicants’ request
to find that the OSHA Mandate exceeds the agency’s
authority. But first, it is imperative to explain why the
OSHA Mandate is properly understood as an
experimental vaccine mandate. Currently, the only
COVID-19 “vaccine”5 that has been approved by the
Cir. Dec. 17, 2021) (internal citations omitted throughout)
(“MCP”).
5 Here and in the proceedings where DTR represents
service members challenging DOD mandates, see John Doe #1 v.
Austin, No. 3:21-cv-1211 (N.D. Fla.) (subsequently captioned
Coker v. Austin) and Crosby v. Austin, 8:21-cv-2730 (M.D. Fla.),
DTR’s clients and expert witnesses dispute the FDA’s
characterization of COVID-19 treatments as “vaccines.”
Instead,the new products should be classified as one treatment
among many other alternatives. Unlike traditional vaccines, the
COVID-19 “vaccines” have a short and rapidly waning efficacy,
cannot prevent infection or transmission, require booster shots,
and utilize an entirely novel mechanism of action (mRNA) and
delivery (nanolipids). DTR’s position is proved by the CDC itself,
which changed its own definition of “vaccine” and “vaccination”
within a week after the FDA’s August 23, 2021, approval of
Comirnaty to reflect the fact that, unlike traditional vaccines,
these COVID-19 treatments provide “protection” rather than
“immunity.” Compare CDC, Vaccines and Immunizations:
Definition of Terms, available at: http://web.archive.org/
web/20120710132002/https://www.cdc.gov/vaccines/vac-gen/imz-
basics.htm (last visited Dec. 28, 2021) (defining “vaccine” as “[a]
product that produces immunity therefore protecting the body
from the disease.”) with CDC, Vaccines and Immunizations:
Definition of Terms (Aug. 26, 2021), available at:
http://web.archive.org/web/20210826113846/https://www.cdc.gov
/vaccines/vac-gen/imz-basics.htm (last visited Dec. 27, 2021)
(defining “vaccine as “[a] product that stimulates a person’s
immune system to produce immunity to a specific disease,
protecting the person from that disease.”). For the avoidance of
confusion, however, DTR will refer to these treatments as
“vaccines.” These products also have produced adverse events
including deaths, heart attacks, strokes, and severe neurological
problems. See CDC, Selected Adverse Events Reported After
4
FDA is Pfizer-BioNTech’s Comirnaty, which is not
available in the United States. The only COVID-19
products that are available are not FDA approved and
instead are subject to an EUA.
As explained below, the distinction between an
EUA and an FDA-approved product matters. See infra
Section III. In particular, the FDA’s grant of EUA
requires little, if any, demonstration that the EUA
product is safe and effective. Nor does the EUA include
FDA review or approval of manufacturing processes,
facilities, storage, distribution, or quality control
procedures. This is why the FDA has acknowledged
the products are “legally distinct.”6
The unavailability of Comirnaty raises a second
question that also has not been asked, much less
addressed, by OSHA or in the judicial decisions under
review. Federal laws and applicable FDA regulations
expressly provide a “right to refuse” experimental or
EUA products. See 21 U.S.C. § 360bbb-
3(e)(1)(A)(ii)(III). Yet, the OSHA Mandate unlawfully
overrides or circumvents those laws.
These rights to informed consent and to refuse
experimental drugs—embodied not only in federal law,
like 21 U.S.C. § 360bbb-3, but also international law
and conventions like the Nuremburg Code—should
foreclose such a wide-ranging mandate. DTR urges
this Court to consider the enormous wrongful
consequences of imposing an illegal mandate requiring
COVID-19 Vaccination, available at: https://www.cdc.gov/corona
virus/2019-ncov/vaccines/safety/adverse-events.html (last visited
Dec. 28, 2021).
6 See FDA, Pfizer-BioNTech EUA Letter at 2 n.8 (Aug. 23,
2021) (“FDA BioNTech EUA Expansion Letter”), available at:
https://www.fda.gov/media/150386/download (last visited Dec.
27, 2021).
5
nearly the entire United States adult workforce to take
an experimental and irreversible medical treatment.
The immeasurable ramifications of endorsing a
near-universal federal mandate justify granting a stay
to give more time for deeper consideration by this
Court, the political branches, public health experts,
and the citizens of the United States to consider the
legal arguments and scientific evidence on the safety
and efficacy of the newly manufactured “vaccines,” the
rapidly proliferating range of therapies, and
alternative federal, state, and local public health
measures. Surely a stay to allow this Court to hear the
arguments presented by all Parties and Amici is
appropriate given the momentous consequences for
tens of millions of Americans who face the loss of their
rights to work, education, travel, worship and other
fundamental constitutional rights unless they submit
to an unproven, experimental medical treatment with
an unprecendented history of adverse effects including
deaths.
ARGUMENT
I. The Development of COVID-19 Vaccines
The pharmaceutical industry undoubtedly moved
quickly to develop vaccines in response to the COVID-
19 pandemic. This was done in conjunction with the
United States government’s Operation Warp Speed,
that awarded billions to these companies to spur the
development and distribution of the vaccines.7 To clear
the way for expedited development, the Secretary of
7 Congressional Research Service, Operation Warp Speed
Contracts for COVID-19 Vaccines and Ancillary Vaccination
Materials, (Mar. 1, 2021), available at: https://crsreports.
congress.gov/product/pdf/IN/IN11560 (last visited Dec. 27, 2021).
6
Health and Human Services (“HHS”) issued notice,
pursuant to section 564 of the Federal Food, Drug, and
Cosmetic Act, 21 U.S.C. § 360bbb-3, that COVID-19
had a “significant potential to affect national security
or the health and security of United States Citizens”
and that “circumstances exist justifying the
authorization of emergency use of drugs and biological
products during the COVID–19 pandemic.” 85 Fed.
Reg. 18,250 (April 1, 2020).
The currently available COVID-19 “vaccines” are
the results of these efforts. The Pfizer-BioNTech
vaccine received its EUA on December 11, 2021.8 This
was followed by EUAs for the Moderna and Johnson
and Johnson Vaccines (“Moderna Vaccine” and
“Janssen Vaccine”) on December 18, 2021 and
February 27, 2021, respectively.9 These EUAs were
granted after limited testing. For example, the Pfizer-
BioNTech Vaccine’s EUA was issued based on an
“entire enrolled study population [that] had a median
follow-up of less than 2 months.”10 Typically, vaccines
8 FDA, FDA Takes Key Action in Fight Against COVID-19
by Issuing Emergency Use Authorization for First COVID-19
Vaccine (Dec. 11, 2020), available at: https://www.fda.gov/news-
events/press-announcements/fda-takes-key-action-fight-against-
covid-19-issuing-emergency-use-authorization-first-covid-19
(last visited Dec. 27, 2021).
9 Carl Zimmer, et al., Coronavirus Vaccine Tracker, THE
NEW YORK TIMES (last updated Dec. 22, 2021) (“NY Times COVID
Tracker”) available at: https://www.nytimes.com/interactive/
2020/science/coronavirus-vaccine-tracker.html (last visited Dec.
27, 2021).
10 See FDA, Emergency Use Authorization for an
Unapproved Product: Review Memorandum (Pfizer-BioNTech
COVID-19 Vaccine / BNT162b2) at 17 (Nov. 20, 2020) (“FDA
Pfizer-BioNTech EUA Review Memo”), available at:
https://www.fda.gov/media/144416/download (last visited Dec.
27, 2021).
7
“require years of research and testing before reaching
the clinic.”11
II. The FDA-Approved Comirnaty is Unavailable
to the American Public
On August 23, 2021, the FDA approved the Pfizer-
BioNTech mRNA vaccine under the marketed name
Comirnaty.12 Soon thereafter, on September 9, 2021,
President Biden announced that he would “protect
vaccinated workers from unvaccinated co-workers” by
having the Department of Labor issue “an emergency
rule to require all employers with 100 or more
employees . . . to ensure their workforces are fully
vaccinated or show a negative test at least once a
week.”13
With these marching orders, the Secretary of
Labor, through OSHA, issued the OSHA ETS, which
mandated that private businesses with 100 or more
employees “develop, implement, and enforce a
mandatory COVID-19 vaccination policy, with an
exception for employers that instead adopt a policy
11 NY Times COVID Tracker. See also Gail A. Van Norman,
MD, Drugs, Devices and the FDA: Part 1: An Overview of Approval
Processes for Drugs, JACC: Basic to Translational Science, Apr.
2016;1(3): 170-79 (explaining that it typically takes 10 years or
more for initial review and clinical trials to FDA approval). FDA
approval of Comirnaty took approximately three months from
May 18 to August 23, 2021.
12 FDA, FDA Approves First COVID-19 Vaccine, FDA Press
Release (Aug. 23, 2021), available at: https://www.fda.gov/news-
events/press-announcements/fda-approves-first-covid-19-vaccine
(last visited Dec. 27, 2021).
13 White House, Remarks by President Biden on Fighting
the COVID-19 Pandemic (Sept. 9, 2021), available at:
https://www.whitehouse.gov/briefing-room/speeches-remarks/
2021/09/09/remarks-by-president-biden-on-fighting-the-covid-19-
pandemic-3/ (last visited Dec. 27, 2021).
8
requiring employees to either get vaccinated or elect to
undergo regular COVID-19 testing and wear a face
covering at work in lieu of vaccination.” OSHA ETS,
86 Fed. Reg. at 61,402. Americans subject to this ETS
are in compliance if they receive the recommended
minimum doses of COVID-19 vaccines that are
“[a]pproved or authorized for emergency use by the
FDA.” Id. at 61,479.
Notwithstanding the jurisdictional issues
underlying the OSHA Mandate, there is a significant
problem concerning how Americans are forced to
comply with the mandate. Specifically, the only FDA-
approved vaccine – Comirnaty – is not available to the
American public. According to the CDC,
“COMIRNATY products are not orderable at this
time.”14 As of December 16, 2021, “there is not
sufficient approved vaccine [i.e., Comirnaty] available
for the population for whom it is authorized.” See
supra, FDA Pfizer-BioNTech Expansion Letter, note 6
at 5 n.9. In fact, it appears that Comirnaty is not
available at all in the United States. Pfizer and the
National Institutes of Health confirmed that
Comirnaty would be unavailable for months after its
approval.15
14 CDC, COVID-19 Vaccine Codes, available at:
https://www.cdc.gov/vaccines/programs/iis/COVID-19-related-
codes.html (last visited Dec. 28, 2021).
15 On September 13, 2021, the National Institutes of Health
(“NIH”) posted an announcement by Pfizer that Pfizer “does not
plan to produce any product with these new [Comirnaty] NDCs
and labels over the next few months while the EUA authorized
product is still available and being made available for U.S.
distribution.” See NIH-Pfizer Announcement of Comirnaty
Unavailability (Sept. 13, 2021), available at: https://www.cdc.gov/
vaccines/programs/iis/COVID-19-related-codes.html (last visited
Dec. 27, 2021). See also FDA, Summary Basis of Regulatory
9
The Department of Justice (“DOJ”) finally
conceded the unavailability of Comirnaty through
defense counsel for DOD in Austin, where DTR
represents service members challenging the DOD
Mandate. While DOD initially claimed that the DOD
in fact possessed Comirnaty and was administering it
to service members, in oral argument, DOJ defense
counsel acknowledged that not only did it not have
Comirnaty and did not know when it would it get it,
but also “could not say even whether vaccines labeled
‘Comirnaty’ exist at all.” Doe v. Austin, 2021 WL
5816632, at *5 (N.D. Fla. Nov. 12, 2021) (citations
omitted).16
DOD is the largest purchasing organization in the
United States, and given its priority for national
security matters, it would necessarily go to the front of
Action – Comirnaty at 5 (Nov. 8, 2021) (“November 8 Comirnaty
SBRA”) (“In the U.S., there are no licensed vaccines or anti-viral
drugs for the prevention of COVID-19.”), available at:
https://www.fda.gov/media/151733/download (last visited Dec.
27, 2021).
16 The government’s fallback position was that, while DOD
does not have Comirnaty, it is instead administering EUA-
labeled vials that the DOD claims are chemically identical to, and
manufactured in accordance with, the requirements of the FDA
license, which the government refers to as “BLA-compliant”
vaccines. See Austin, 2021 WL 5816632, at *5. The government’s
position is incorrect for the reasons set forth below. See infra
Section III. In any case, there is no discussion or mention of “BLA-
compliant” vaccines in the OSHA ETS, nor does OSHA claim that
there are sufficient BLA-compliant vials currently available to
implement the OSHA Mandate. Accordingly, OSHA may not rely
on “BLA-compliant” vaccines to defend its mandate because
courts may not uphold agency actions based on reasons that the
agency never gave. See, e.g., SEC v. Chenery, 318 U.S. 80, 87
(1943). Nor is there any showing that the “vaccines” are identical.
They are not by definition. If they were, they could be labeled
Comirnaty.
10
the line for any purchasing COVID-19 vaccines. Yet
DOD does not have Comirnaty and to this day the
DOD cannot say when it will get Comirnaty. If the
DOD cannot obtain Comirnaty, then how can average
Americans who are subject to the OSHA Mandate?
And perhaps more importantly, how can employees be
fired for the failure of their employers to obtain a
vaccine that even the DOD cannot procure?
The unavailability of Comirnaty is important.
First, while OSHA purports to give employers the
option of requiring vaccination or allowing testing and
masks, it does not hide its real intent to force
employees to choose vaccination to keep their jobs. If
an employee opts out of their employer’s mandatory
vaccination policy, OSHA believes its ETS and the
costs it imposes on that employee – which includes
paying for regular testing – “creates a financial
incentive for those employees to become fully
vaccinated and avoid that cost.” OSHA Mandate, 86
Fed. Reg. at 61,532.
As Judge Larsen observed in his dissenting
opinion on the emergency motion to dissolve the stay
of the OSHA Mandate, the Mandate’s main purpose is
to compel vaccination:
Here, employers, not employees, control any
non-vaccine option in the first instance; and
OSHA has been candid that it has stacked the
deck in favor of vaccination … OSHA has
alerted us to no prior attempt on its part to
mandate a solution that extends beyond the
workplace walls— much less a permanent and
physically intrusive one, promulgated on an
emergency basis, without any chance for
public participation. But that it is what OSHA
has done here. A vaccine may not be taken off
11
when the workday ends; and its effects, unlike
this rule, will not expire in six months.17
Second, and in consideration of OSHA’s coercive
policy, workers will only be able to comply with the
OSHA Mandate if they receive a vaccine under an
EUA.18 This is especially important because EUA
vaccines bypass the FDA and PHS Act’s requirements
for safety and efficacy.
III. Important Differences Between EUA and
FDA-Approved Vaccines
There are significant differences between the
FDA’s approval standards and the EUA standards.
EUA vaccines require little to no proof of safety or
efficacy. FDA vaccine approvals do.
The FDA may grant an EUA where: (1) the HHS
Secretary has declared a public health emergency that
justifies the use of an EUA, see 21 U.S.C. § 360bbb-
3(b)(1); and (2) the FDA finds that “there is no
adequate, approved, and available alternative to the
product for diagnosing, preventing, or treating” the
disease in question. 21 U.S.C. § 360bbb-3(c)(3).
17 MCP, 2021 WL 5989357, at *27 (Larsen, C.J., dissenting)
(citations omitted).
18 The Sixth Circuit majority’s comparison of the current
OSHA Mandate to the 1991 OSHA standard requiring employers
to make the Hepatitis B vaccine available to certain employees,
29 C.F.R. § 1910.1030(f), is inapposite for two reasons. First,
OSHA only required employers to make it available to employees.
Second, by that time the Hepatitis B vaccine had long been
approved by the FDA and its side effects were within the range of
tolerable adverse incidents. See CDC, Epidemiology and
Prevention of Vaccine-Preventable Diseases, available at:
https://www.cdc.gov/vaccines/pubs/pinkbook/hepb.html (last
visited Dec. 27, 2021) (noting that the Hepatitis B vaccine “was
first licensed for use in the United States in 1981”).
12
The differences between licensed vaccines and
those subject to an EUA render them “legally distinct.”
See supra, FDA Pfizer-BioNTech EUA Expansion
Letter, note 6 at 2 n.8. First, the requirements for
efficacy are much lower for EUA products than for
licensed products. EUAs require only a showing that,
based on scientific evidence “if available,” “it is
reasonable to believe,” the product “may be effective”
in treating or preventing the disease. 21 U.S.C.
§360bbb-3(c)(2)(A).
By plan, those vaccines that are subject to the
OSHA Mandate have relatively little data to support
their authorization. The Pfizer-BioNTech Vaccine was
granted its EUA after approximately 2 months of
follow-up testing. See supra, FDA Pfizer-BioNTech
EUA Review Memo, note 10 at 17. The Moderna
Vaccine received its EUA after providing its studies to
the FDA “with a median of 7 weeks of follow-up after
the second dose.”19 And for the Janssen Vaccine, which
also received an EUA, “the median follow-up duration
for participants in the efficacy and safety analysis
populations was 8 weeks after vaccination.”20
Second, the safety requirements are minimal,
requiring only that the FDA conclude that the “known
and potential benefits … outweigh the known and
potential risks” of the product, considering the risks of
19 See FDA, Emergency Use Authorization for an
Unapproved Product: Review Memorandum (Moderna COVID-19
Vaccine) at 6-7 (Dec. 18, 2020) (“FDA Moderna EUA Review
Memo”), available at: https://www.fda.gov/media/144673/
download (last visited Dec. 27, 2021).
20 See Emergency Use Authorization for an Unapproved
Production Review Memorandum (Janssen COVID-19 Vaccine)
at 18 (Feb. 27, 2021) (“FDA Janssen EUA Review Memo”),
available at: https://www.fda.gov/media/146338/download (last
visited Dec. 27, 2021).
13
the disease. 21 U.S.C. §360bbb-3(c)(2)(B). There is no
requirement that the FDA know the potential risks of
the product.
In comparison, vaccines that go through
traditional FDA review typically take 10 years or more
to reach approval.21 And the approval process compiles
more information on the risks of the vaccine, gathered
through lab testing and clinical trials, “to assess the
safety and effectiveness of each vaccine.”22
A. The Right to Refuse an EUA Vaccine
The FDA’s grant of an EUA is subject to informed
consent requirements to “ensure that individuals to
whom the product is administered are informed” that
they have “the option to accept or refuse
administration of the product.” 21 U.S.C. § 360bbb-
3(e)(1)(A)(ii)(III).
For the three COVID-19 vaccines, FDA
implemented the “option to accept or refuse” condition
described in Section 564(e)(1)(A)(ii)(III) in each letter
granting the EUA by requiring that FDA’s “Fact Sheet
for Recipients and Caregivers” be made available to
every potential vaccine recipient. These include the
statement that the recipient “has the option to accept
21 See supra Norman, note 11. See also HHS, Vaccine Safety
(the process to test a vaccine in labs – before there is a decision to
test it on people – “can take several years.”), available at:
https://www.hhs.gov/immunization/basics/safety/index.html (last
visited Dec. 27, 2021).
22 FDA, Ensuring the Safety of Vaccines in the United
States, last updated July 2011, available at: https://www.fda.gov/
files/vaccines,%20blood%20&%20biologics/published/Ensuring-
the-Safety-of-Vaccines-in-the-United-States.pdf (last visited Dec.
27, 2021).
14
or refuse” the vaccine.23 Moreover, the EUA label itself
must expressly state that the recipient has a “right to
refuse” administration of the EUA product.
Accordingly, the OSHA Mandate contradicts
established federal law and will require any covered
employer, including state agencies, to violate an
express requirement of federal law and the express
terms of the FDA labeling and packaging
requirements.
B. OSHA Cannot Override Informed Consent
Rights
The norm of informed consent has been “firmly
embedded” in U.S. law and FDA regulations for nearly
60 years. Adullahi v. Pfizer, Inc., 562 F.3d 163, 182 (2d
Cir. 2009). Congress first enacted this requirement in
1962 drawing on the Nuremberg Code and the
Helsinki Declaration, “which suggests the government
conceived of these sources’ articulation of the norm as
a binding legal obligation.” Adullahi, 562 F.3d at 182.
Informed consent requirements are a cornerstone of
FDA rules governing human medical experimentation.
See, e.g., 21 C.F.R. §§ 50.20, 50.23-.25, 50.27, 312.20,
312.120 (2008); 45 C.F.R. §§ 46.111, 46.116-117.
In any case, OSHA has not even acknowledged
workers’ informed consent rights, much less explained
how its mandate can override these rights or force
private and public sector employers into violating
these rights. Accordingly, the OSHA Mandate cannot
stand.
23 See, e.g., Fact Sheet for Healthcare Providers
Administering Vaccine (Moderna COVID-19 Vaccine) (Revised
Dec. 9, 2021), available at: https://www.fda.gov/media/144637/
download (last visited Dec. 27, 2021).
15
A helpful analogy when considering forced
vaccination is to compare the present case to the
DOD’s much narrower Anthrax Vaccination
Immunization Program. Courts enjoined that
program, as it sought to impose a vaccine mandate on
service members using experimental, unapproved
anthrax mandates, which were expressly barred by
statute. See 10 U.S.C. §§ 1107 and 1107a. Even in
those cases, courts recognized the limitations of DOD
power over military service members, observing “the
United States cannot demand that members of the
armed forces also serve as guinea pigs for
experimental drugs.” Doe No. 1 v. Rumsfeld, 297
F.Supp.2d 119, 135 (D.D.C. 2003) (granting injunctive
relief against DOD for mandating an EUA anthrax
vaccine).24 Certainly, OSHA has even less authority
over American workers.
IV. EUA and FDA Licensed Products do not have
the “Same Formulation” and are not
“Interchangeable”
Notwithstanding any potential assertions to the
contrary, the EUA and licensed versions of Pfizer-
BioNTech do not have the “same formulation” as
revealed by a simple inspection of the Pfizer Vaccine
EUA letters and the Summary Basis for Regulatory
Action (SBRA) for Comirnaty. Thus, they cannot be
treated as “interchangeable,” because there is no legal
basis to administer an EUA product as if it were the
FDA-licensed product. By definition, they are different.
24 See also John Doe #1 v Rumsfeld, 341 F. Supp. 2d 1
(D.D.C. 2004) (enjoining mandate of anthrax vaccine as
investigational new drug under 10 U.S.C. § 1107), modified 2005
WL 774857 (D.D.C. 2005) (expanding injunction against
mandated EUA anthrax vaccine under 10 U.S.C. § 1107a).
16
There is no evidence in the public record for
finding that the EUA Pfizer-BioNTech vaccine and
FDA-licensed Comirnaty have the “same formulation.”
There is, however, ample evidence for finding that
they do not. The most detailed information on
Comirnaty’s composition, manufacturing process,
manufacturing locations and other matters approved
by the FDA is included in the FDA Comirnaty SBRA,
nearly all of which is redacted,25 while most of this
information was never made available in the Pfizer-
BioNTech EUA applications or authorizations. To the
extent such information is available, it reveals
differences in the composition of the EUA and the
licensed product.26 There is also no dispute that the
FDA EUA does not address manufacturing processes
or locations, which are addressed in the Comirnaty
license. See August 23 Comirnaty SBRA at 12-13.
For the same reasons, the public record does not
support any argument that the two admittedly “legally
distinct” products are “interchangeable.”
“Interchangeable” and “interchangeability” are
25 See FDA, Summary Basis for Regulatory Action (Pfizer
Vaccine), Nov. 8, 2011, available at: fda.gov/media/151733/
download (last visited Dec. 27, 2021).
26 See Doe v. Austin, 2021 WL 5816632, at *3 n.5. Compare
Summary Basis of Regulatory Action, BLA 125742/0 at 9 (Aug.
23, 2021) (“August 23 Comirnaty SBRA”) (listing 11 components,
including .450 ml per vial of a redacted excipient) (this document
has been scrubbed from the FDA website, but was filed as an
exhibit in the Doe v. Austin and Crosby v. Austin proceedings and
can be filed with the Court if the amicus motion is granted), with
FDA BioNTech EUA Expansion Letter, supra, note 6 at 7 (listing
10 components, all of which also appear on the Comirnaty SBRA)
and November 8 Comirnaty SBRA at 7-8 (listing 11 components,
but removing .450 ml per vial of redacted excipient and replacing
with unspecified amount of water as 11th component).
17
specifically defined terms in Section 351 of the Public
Health Service Act (“PHS Act”), 42 U.S.C. § 262, in
relation to a “reference product,” which is a biological
product licensed under Section 351(a) of the PHS Act,
42 U.S.C. § 262(a). For the purposes of determining
“interchangeability,” the “reference product” must be
an FDA-licensed product; in this case, the FDA-
licensed Comirnaty Vaccine. But the
“interchangeable” product, the EUA BioNTech
Vaccine, must be the subject of a later filed
“abbreviated” application under 42 U.S.C. § 262(k),
and there is no indication that any such application
was ever filed by BioNTech, much less reviewed or
approved by the FDA.
Any “interchangeability” determination would
therefore reverse the temporal order of the COVID-19
licensed product and the interchangeable product. The
reference product under 42 U.S.C. § 262(a) is the first
licensed product, and therefore the basis for
determining the interchangeability of the later
product (i.e., the generic or EUA product). Here,
however, the EUA Pfizer-BioNTech Vaccine is the
earlier product, while the licensed Comirnaty is the
latter product; the earlier EUA product cannot rely on
the FDA's safety and efficacy determinations for
Comirnaty. Thus, an “interchangeability”
determination would be a transparent attempt to
retroactively license the earlier EUA Pfizer-BioNTech
Vaccine, solely for the purpose of enabling the
unlawful vaccine mandate.
Moreover, “FDA licensure does not retroactively
apply to vials shipped before [FDA] approval.” Austin,
2021 WL 5816632, at *6. Any EUA-labeled vaccines
manufactured before licensure and “vaccines produced
after August 23 in unapproved facilities—remain
‘product[s] authorized for emergency use,’” i.e., EUA
18
rather than licensed products. Id. In any case, such a
post hoc interchangeability determination should not
even be considered by the Court. “An agency must
defend its actions based on the reasons it gave when it
acted.” DHS v. Regents of the Univ. of Cal., 140 S.Ct.
1891, 1909 (2020).
CONCLUSION
This Court should stay the OSHA Mandate
because the unavailability of Comirnaty precludes
compliance. Congress has not clearly granted the
agency the power to require private employers to
mandate that their employees take an experimental
vaccine.27 Congress has not granted OSHA the
authority to require State agencies to impose and
police a mandate which cannot be satisfied through
distribution of FDA-approved vaccines. No American
can be compelled to suffer an injection of an
experimental product.
27 See Alabama Assn. of Realtors v. Department of Health
and Human Services, 594 U.S. __, 2021 U.S. LEXIS 3679, at *8
(Aug. 26, 2021) (per curiam) (Congress must “speak clearly when
authorizing an agency to exercise vast powers of economic and
political significance.”)
19
Respectfully submitted,
/s/ Howard Kleinhendler
HOWARD KLEINHENDLER
Counsel of Record
HOWARD KLEINHENDLER ESQUIRE
369 Lexington Avenue, 12th Floor
New York, New York 10017
(917) 793-1188
howard@kleinhendler.com
SIDNEY POWELL
SIDNEY POWELL, P.C.
2911 Turtle Creek Blvd., Suite 300
Dallas, Texas 75219
(214) 707-1775
sidney@federalappeals.com
Counsel for Movant/Proposed Amicus
Defending The Republic, Inc.
Of Counsel:
BRANDON JOHNSON
TRAVIS MILLER
DEFENDING THE REPUBLIC, INC.
2911 Turtle Creek Blvd., Suite 300
Dallas, Texas 75219
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