Court filing

Plaintiffs' Opposition to Motion to Dismiss — Norris v. Stanley

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Court	UNITED STATES DISTRICT COURT
Filed	2021-12-17

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The plaintiffs' response in opposition to the defendants' motion to dismiss in Norris v. Stanley, Civil Action No. 1:21-cv-00756, in the U.S. District Court for the Western District of Michigan, filed December 17, 2021 as ECF No. 62. It argues that the level of scrutiny for COVID-19 vaccine mandates is unresolved and that MSU's vaccine directive fails even rational basis review. It further argues that the directive is an unconstitutional condition and is preempted by the informed consent provision at 21 U.S.C. § 360bbb-3, and that none of the vaccines available for intake had full FDA approval. It states that international human rights law was cited as guidance rather than as a cause of action, and asks the court to deny the motion. A certificate of compliance under LCivR 7.2(b)(i) reports 7,361 words, and the filing is 35 pages.

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IN THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF MICHIGAN
SOUTHERN DIVISION

JEANNA NORRIS, KRAIG EHM,
D’ANN ROHRER, et al.,

HON. PAUL MALONEY, U.S.D.J.

Plaintiffs,

Civil Action No.

1:21-cv-00756
SAMUEL STANLEY, et al.,

Defendants.

PLAINTIFFS’ RESPONSE IN OPPOSITION TO
DEFENDANTS’ MOTION TO DISMISS
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1374 Filed 12/17/21 Page 1 of 35

TABLE OF CONTENTS
TABLE OF AUTHORITIES ......................................................................................................................... ii
BACKGROUND .............................................................................................................................................. 1
STANDARD OF REVIEW ............................................................................................................................ 8
ARGUMENT..................................................................................................................................................... 9
I.
WHAT LEVEL OF SCRUTINY SHOULD APPLY TO PLAINTIFFS’ CLAIMS REMAINS AN OPEN
QUESTION, BUT MSU’S VACCINE POLICY DOES NOT EVEN SURVIVE RATIONAL BASIS REVIEW ... 9
A.
Whether Strict Scrutiny or Rational Basis Analysis Applies to COVID-19 Vaccine
Mandates Is Unresolved ........................................................................................................................ 10
B.
MSU’s Vaccine Directive Does Not Satisfy Rational Basis Review ....................................... 12
II.
CONTRARY TO DEFENDANTS’ CLAIMS, MSU’S VACCINE DIRECTIVE CONSTITUTES AN
UNCONSTITUTIONAL CONDITION ............................................................................................................ 20
A.
Plaintiffs Do Not Have to Allege Violation of an Enumerated Right in Order to Succeed
on this Claim ............................................................................................................................................ 20
B.
Constitutional Rights Are at Issue Here ..................................................................................... 21
C.
MSU’s Policy Is Coercive Under Unconstitutional Conditions Doctrine ............................. 22
III. MSU’S VACCINE MANDATE IS PREEMPTED BY FEDERAL LAW .................................................. 24
A. Plaintiffs Are Entitled to Bring Claims for Declaratory and Injunctive Relief Under 21
U.S.C. § 360bbb-3 for Violations of Their Statutory Rights to Informed Consent ..................... 24
B.
None of the Vaccines Actually Available for Intake Has Received Full FDA Approval ... 26
IV. PLAINTIFFS CITED HUMAN RIGHTS LAW AS A SOURCE OF GUIDANCE, NOT AS A CAUSE OF
ACTION ......................................................................................................................................................... 29
CONCLUSION ............................................................................................................................................... 30

Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1375 Filed 12/17/21 Page 2 of 35

TABLE OF AUTHORITIES
Cases
Appalachian Power v. EPA, 208 F.3d 1015 (D.C. Cir. 2000) .............................................................. 28
Armstrong v. Exceptional Child Center, 575 U.S. 320m 326 (2015) ....................................................... 25
Arnold v. Heyns, 2015 WL 4243269 (E.D. Michigan 2015) ................................................................. 8
Ashcroft v. Iqbal, 556 U.S. 662 (2009) ................................................................................................. 9
Board of Trustees v. Garrett, 531 U.S. 356 (2001) ................................................................................ 25
Bridges v. Houston Methodist Hospital, No. H-21-1774, 2021 WL 239994 at *2 (S.D. Tex. June 12, 2021)
................................................................................................................................................... 24
BST Holdings v. OSHA, No. 21-60845 (Nov. 12, 2021) ............................................................ passim
Carver v. Bunch, 946 F.2d 451 (6th Cir. 1991) ...................................................................................... 8
Christensen v. Harris County, 529 U.S. 576 (2000) ............................................................................... 27
Crosby v. National Foreign Trade Council, 530 U.S. 363 (2000) ............................................................. 25
Cruzan v. Dir., Mo. Dep’t of Public Health, 497 U.S. 261 (1990) .......................................................... 11
Daubert v. Merrell Dow Pharmaceuticals Inc., 509 US 579 (1993) ............................................ 14
DirecTV, Inc. v. Treesh, 487 F.3d (6th Cir. 2007) ............................................................................ 8, 16
Doe v. Austin, No. 3:21-cv-1211-AW-HTC (Nov. 12, 2021) ........................................................ 2, 28
Ex parte Young, 209 U.S. 123, 155-56 (1908) ................................................................................... 25
Fraternal Order of Police Chicago Lodge No. 7, et al. v. City of Chicago, Case No. 2021 CH 5276, at 3
(Circuit Court of Cook County, Ill.)(Nov. 1, 2021) ..................................................................... 23
Gonzaga Univ. v. Doe, 536 U.S. 273 (2002) ....................................................................................... 25
Gregory v. Shelby County, 220 F.3d 433 (6th Cir. 2000) .......................................................................... 8
John Doe v. Austin, Case No. 3:21-cv-01211, Doc. No. 47 at 14, (N.D. Fl., Nov. 12, 2021) .............. 27
Kentucky v. Biden, No. 3:21-cv-00055 * 13 (Nov. 30, 2021)............................................................... 15
King v. Rubenstein, 825 F.3d 206 (4th Cir. 2016) ................................................................................ 11
Klaassen v. Board of Trustees, 2021 WL 3073926 (July 18, 2021) .......................................................... 24
Koontz v. St. Johns River Water Mgmt. Dist., 579 U.S. 595 (2013) ............................................. 20, 21, 23
Leary v. Daeschner, 228 F.3d 729 (6th Cir. 2000) .................................................................................. 8
Louisiana v. Becerra, No. 3:21-cv-03970 (Nov. 30, 2021) ................................................... 5, 12, 16, 22
Maricopa County, 415 U.S. 250 (1974) ................................................................................... 20, 21, 22
Merck Sharp & Dohme Corp. v. Conway, 2012 WL 1029427, fn. 5 (E.D. Kentucky 2012) ..................... 9
Missouri v. Biden, 2021 WL 5564501 (E.D. Mo. Nov. 29, 2021) ................................................ passim
Norris v. Stanley, __F.3d.___, 2021 WL 3891615 (W.D. Michigan 2021) .......................................... 21
R.S.W.W. v. City of Keego Harbor, 397 F.3d 427 ................................................................................ 21
Regan v. Taxation With Representation of Wash., 461 U.S. 540 (1983) ................................................... 21
Ricco v. Potter, 377 F.3d 599 (6th Cir. 2004) ......................................................................................... 8
Speiser v. Randall, 357 U.S. 513 (1958) .............................................................................................. 23
United States v. Generix Drug Corp., 460 U.S. 453 (1983) .................................................................... 28
Vacco v. Quill, 521 U.S. 793 (1997) .................................................................................................. 12
Washington v. Glucksberg, 521 U.S. 702, 722 n.17 (1997) .................................................................... 11
Statutes
10 U.S.C. § 1107a ........................................................................................................................... 27
21 U.S.C. § 360bbb-3 ........................................................................................................... 1, 24, 26
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1376 Filed 12/17/21 Page 3 of 35

iii

Other Authorities
“Delta Variant: What We Know About the Science,” CDC (Aug. 26, 2021) .................................. 18
“Memorandum Opinion for the Deputy Counsel to the President,” Whether Section 564 of the Food,
Drug, and Cosmetic Act Prohibits Entities from Requiring the Use of a Vaccine Subject to an Emergency Use
Authorization (July 6, 2021) ............................................................................................................ 1
“US panel recommends J & J Shots be sidelined after clot deaths,” BBC News (Dec. 16, 2021) ........ 4
FDA Approves First COVID-19 Vaccine, (Aug. 23, 2021) ................................................................... 2
FDA, “Letter to Pfizer, Inc.” (October 29, 2021) ............................................................................. 2
FDA, Emergency Use Authorization for Vaccines Explained (Nov. 20, 2020) ............................................ 1
FDA, Vaccine Information Fact Sheet for Recipients and Caregivers about COMIRNATY
(COVID-19 Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus
Disease 2019 (COVID-19) (Aug. 23, 2021) ................................................................................ 27
Jennifer Block, “Vaccinating people who have had covid-19: why doesn’t natural immunity count in
the US?” BRITISH MEDICAL JOURNAL (Sept. 13, 2021) ................................................................. 4
Marty Makary, “Covid Confusion at the CDC,” The Wall Street Journal (Sept. 13, 2021) ........ 17
Paul Elias Alexander, “137 Research Studies Affirm Naturally Acquired Immunity to Covid-19,”
Brownstone Institute (Oct. 17, 2021) ............................................................................................... 19
Roni Caryn Rabin, “The Coronavirus Attacks Fat Tissue, Scientists Find,” The New York Times (Dec.
8, 2021) ...................................................................................................................................... 13
SARS-CoV-2 Vaccines: Lights and Shadows, 88 EUR. J. INTERNAL MED. 1, 8 (2021)............................. 4

Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1377 Filed 12/17/21 Page 4 of 35

BACKGROUND
Last winter, FDA approved three vaccines pursuant to the federal Emergency
Use Authorization (EUA) statute, 21 U.S.C. § 360bbb-3: the Pfizer BioNTech,
Moderna, and Johnson and Johnson (Janssen) vaccines. See First Amended Complaint,
ECF No. 55 at ¶ 20 (“FAC”). Pfizer’s Comirnaty Vaccine received full FDA approval
on August 23, 2021. Id. at ¶ 20(d).
EUAs allow FDA to make a product available to the public following a truncated
testing process, and based on the best available data, without waiting for all the evidence
needed for full FDA approval or clearance. FDA, Emergency Use Authorization for Vaccines
Explained (Nov. 20, 2020), available at bit.ly/3x8wImn (last visited August 26, 2021). See
FAC at ¶¶ 23-30 (for a more detailed explanation of the differences between
EUA and full FDA approval). Products granted an EUA have not been proven safe
and effective. See “Memorandum Opinion for the Deputy Counsel to the President,”
Whether Section 564 of the Food, Drug, and Cosmetic Act Prohibits Entities from Requiring the Use
of a Vaccine Subject to an Emergency Use Authorization (July 6, 2021) (OLC Op.) at 7-13,
available at https://www.justice.gov/olc/file/1415446/download (last visited Aug.1,
2021).
There has been significant confusion over whether the BioNTech and Comirnaty
vaccines are, in actuality, the same. In a letter to Pfizer, FDA stated that “the Pfizer-
BioNTech COVID-19 Vaccine that uses PBS buffer and COMIRNATY (COVID-19
Vaccine, mRNA) have the same formulation. The products are legally distinct with
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1378 Filed 12/17/21 Page 5 of 35

certain differences that do not impact safety or effectiveness.” (emphasis added). FDA,
“Letter
to
Pfizer,
Inc.”
(October
29,
2021),
available
at
https://www.fda.gov/media/150386/download (last visited Nov. 4, 2021). See FAC ¶
21.
Generally speaking, certain drugs that the public believes are identical—generic
versions of brand name drugs for instance—do not need to be formulaically identical
to be considered “equivalent.” FDA, “Generic Drugs: questions & Answers,” available
at
https://www.fda.gov/drugs/questions-answers/generic-drugs-questions-
answers#q5 (last visited Nov. 4, 2021). See FAC ¶ 21(c). Despite Pfizer’s proclamations
to the contrary, an analysis of the ingredients in the Comirnaty and BioNTech vaccines
indicates they are not, in fact, identical. Recently, a court recognized as much,
explaining that inactive ingredients may differ in these circumstances, which can
translate into a difference in safety and efficacy. See Doe v. Austin, No. 3:21-cv-1211-
AW-HTC (Nov. 12, 2021), fn. 5.
The Comirnaty Vaccine is not widely available due to limited supply. Pfizer itself
has stated that “there is not sufficient approved vaccine [the Comirnaty] available for
distribution to this population in its entirety at the time of the reissuance of this EUA.”
See id. at p. 9 fn. 7. See also FDA, FDA Approves First COVID-19 Vaccine, (Aug. 23,
2021), available at https://www.fda.gov/news-events/press-announcements/fda-
approves-first-covid-19-vaccine (last visited Oct. 29, 2021). See FAC ¶ 21(a). In fact,
the Task Force Guidance governing the federal employee mandate acknowledges that
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1379 Filed 12/17/21 Page 6 of 35

individuals, depending on their geographic location, may not have access to any specific
COVID-19 vaccine: employees “may not have all types of vaccines available to them.
Agencies should encourage employees to plan ahead and allow enough time to receive
all required vaccine doses before the November 8 deadline to have their second shot.”
United
States
Government,
“Safer
Federal
Work
Force,”
available
at
https://www.saferfederalworkforce.gov/faq/vaccinations/ (last visited Nov. 3, 2021).
See FAC ¶ 21(b).
All medical procedures, including immunizations, carry some risk of side effects.
Though the COVID-19 vaccines appear to be relatively safe at a population level, as
with all medical interventions, some individuals will suffer adverse consequences, even
severe ones. Such side effects may include common, temporary reactions such as pain
and swelling at the vaccination site, fatigue, headache, muscle pain, fever, and nausea.
While rarer, they can also cause serious side effects that result in hospitalization or
death. Declaration of Drs. Martin Kulldorff and Jayanta Bhattacharya, FAC Attachment
A (“Joint Decl.”) ¶¶ 25-26.
The vaccines may very well cause long-term side effects that remain unknown at
this time due to their relatively recent development. Joint Decl.¶¶ 26-27. Put
differently, as a matter of simple logic, it is not possible to be certain about the long-
term effects of a vaccine that has not been in existence for the long term, and thus
cannot have been studied over a span of years. For that reason, “[a]ctive investigation
to check for safety problems is still ongoing.” Joint Decl. ¶ 26.
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1380 Filed 12/17/21 Page 7 of 35

Indeed, just this week the CDC sidelined the Johnson and Johnson vaccine over
concerns about blood clotting issues. “US panel recommends J & J Shots be sidelined
after
clot
deaths,”
BBC
News
(Dec.
16,
2021),
available
at
https://www.bbc.com/news/world-us-canada-59692776 (Dec. 17, 2021). This
underscores the reality that safety investigations are ongoing for these vaccines, and
new information could surface at anytime.
Recent research indicates that vaccination presents a heightened risk of adverse
effects—including serious ones—to those who have previously contracted and
recovered from COVID-19. Joint Decl. ¶ 28; FAC Attachment B (“Noorchashm
Decl.”) ¶¶ 21-26; FAC Attachment C (“Bhattacharya Decl.”) ¶ 30. The heightened risk
of adverse effects results from “preexisting immunity to SARS-Cov-2 [that] may trigger
unexpectedly intense, albeit relatively rare, inflammatory and thrombotic reactions in
previously immunized and predisposed individuals.” Angeli, et al., SARS-CoV-2
Vaccines: Lights and Shadows, 88 EUR. J. INTERNAL MED. 1, 8 (2021). See also Jennifer
Block, “Vaccinating people who have had covid-19: why doesn’t natural immunity
count in the US?” BRITISH MEDICAL JOURNAL (Sept. 13, 2021), available at
https://www.bmj.com/content/374/bmj.n2101 (last viewed Dec. 13, 2021)
(hereinafter “Block article”) (citing several experts and studies establishing that those
who have previously been infected are more likely to experience adverse side effects
from the vaccine).
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1381 Filed 12/17/21 Page 8 of 35

As discussed extensively in the FAC and recognized both historically in the
context of other diseases and most recently by several federal courts, overwhelming
scientific research establishes that immunity following a COVID-19 infection is
equivalent to or perhaps better than that attained through vaccination. FAC ¶ 35-68.
See BST Holdings v. OSHA, No. 21-60845 (Nov. 12, 2021) (“a naturally immune
unvaccinated worker is presumably less at risk than an unvaccinated worker who has
never had the virus.”); Louisiana v. Becerra, No. 3:21-cv-03970 (Nov. 30, 2021) (“the
rejection of natural immunity as an alternative is puzzling”); Missouri v. Biden, 2021 WL
5564501 (E.D. Mo. Nov. 29, 2021) at p. 17 and fn. 20, aff’d Missouri v. Biden, No. 21-
3725 (8th Cir. Dec. 13, 2021) (finding that CMS changing its posture with respect to
natural immunity constituted evidence of unlawful agency action, and noting that “CMS
also rejected natural immunity, despite an intense public debate and a trove of scientific
data on the strength and durability of natural immunity from COVID-19—alone and
compared to vaccine-induced immunity.”). Indeed, the District Court in Becerra queried
why, “[i]f boosters are needed six months after being ‘fully vaccinated,’ then how good
are the COVID-19 vaccines, and why is it necessary to mandate them?” Becerra, No.
3:21-cv-03970 at 26.
As further evidence that natural immunity is robust and durable, the CDC
recently acknowledged that it was unable to document even a single case of a covid-recovered,
unvaccinated individual spreading the virus to another person. See 11/5/21 Letter of
Roger Andoh in Response to FOIA Request, attached as Ex. A). The significance of
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1382 Filed 12/17/21 Page 9 of 35

CDC’s admission cannot be overstated, given that risk of transmission to third parties
is the sole justification for mandating an individual to take the vaccine against their will.
MSU is a public research university located in East Lansing, Michigan. In emails
and on its website, MSU explicated its vaccine mandate (“the Directive”) on July 30,
2021 and August 5, 2021. The Directive required all faculty, staff, and students to be
fully vaccinated or obtain an approved exemption for the Fall 2021 semester by August
31, 2021. As a blanket rule, naturally acquired immunity is explicitly excluded as the
basis for an exemption according to the University’s FAQ page on the subject.
Likewise, employees who work entirely from a remote location must comply with the
Directive. See MSU Covid Directives, FAC Exhibits G-I.
However, MSU accepts as sufficient to satisfy its requirement non-FDA
approved, inferior foreign vaccines such as the Sinovac and Sinopharm, which have
approximately 50% efficacy rates. FAC ¶¶ 60-65, citing Joint Decl. ¶ 37, Noorchashm
Decl. ¶ 29-31. It also accepts the Janssen vaccine, estimated to be about 66% effective
at best. See FAC ¶ 60, citing Joint Decl. ¶ 16, Noorchashm Decl. ¶ 15.
In recognition of the highly protective character of natural immunity, the
European Union has recognized “a record of previous infection” as a substitute for any
vaccine passport requirements. Noorchashm Decl. ¶ 27. Israel, too, exempts from
vaccination requirements those who are COVID-19 recovered. See, e.g., “Covid
passports: How do they work around the world?”, BBC News (July 26, 2021), available
at https://www.bbc.com/news/world-europe-56522408. Even France’s controversial
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1383 Filed 12/17/21 Page 10 of 35

new restrictive mandate on the ability to participate in daily life focuses on a person’s
immunity rather than their vaccine status—treating natural immunity and vaccine
immunity equally. See, e.g., Clea Callcutt, France forced to soften rules after coronavirus green
pass backlash, POLITICO (July 20, 2021), available at https://politi.co/3f9AZzS (last
visited July 29, 2021).
The Plaintiff class representatives in this case are as follows. Jeanna Norris, a 37-
year old supervisory Administrative Associate and Fiscal Officer at MSU, where she has
been employed for eight years. See FAC ¶¶ 72-81. She recovered from a bout of
COVID-19 in November 2020, has naturally acquired immunity, and as a result does
not wish to receive a COVID-19 vaccine. See id. On information and belief, on
November 18, 2021, she applied for a religious exemption from the vaccine
requirement, after commencing litigation in this case, and her request was granted on
the following day.1
Plaintiff Kraig Ehm is a video producer for MSU, where he has been employed
for 21 years. See FAC ¶¶ 82-84. He had COVID-19 in April 2021, and thereby acquired
natural immunity to the virus. Id. Ehm underwent disciplinary proceedings at MSU
because he declined to receive a vaccine, and was terminated from his position on
November 3, 2021 for failure to comply with the Directive. Id.

1 Ms. Norris maintains standing in this case because exemptions may be rescinded, because she is not
guaranteed the same treatment as individuals who have received the vaccine, and because she has an
interest in seeing her natural immunity recognized as such, whatever policies Defendants may adopt.
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1384 Filed 12/17/21 Page 11 of 35

Plaintiff D’Ann Rohrer is an Extension Educator at MSU, where she worked for
6 years. Ms. Rohrer had COVID-19 in August of 2021, and thereby acquired natural
immunity to the virus. FAC ¶¶ 85-87. On information and belief, she was terminated
by MSU on November 5, 2021 for failure to comply with the Directive.
STANDARD OF REVIEW
A motion to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6) should
not be granted “unless it appears beyond doubt that the plaintiff can prove no set of
facts in support of his claim which would entitle him to relief.” DirecTV, Inc. v. Treesh,
487 F.3d 471 (6th Cir. 2007), quoting Ricco v. Potter, 377 F.3d 599, 602 (6th Cir. 2004). In
evaluating such a motion, the court must “construe the complaint in the light most
favorable to the plaintiff, accept its allegations as true, and draw all reasonable
inferences in favor of the plaintiff.” DirecTV, Inc., 487 F.3d at 476. The burden is on
the defendant to show that the plaintiff has failed to state a claim for relief. Id., citing
Carver v. Bunch, 946 F.2d 451, 454-55 (6th Cir. 1991). The court “need not accept as true
legal conclusions or unwarranted factual inferences.” Gregory v. Shelby County, 220 F.3d
433, 446 (6th Cir. 2000). This standard is, of course, vastly different from that used to
grant a preliminary injunction. See Arnold v. Heyns, 2015 WL 4243269 (E.D. Michigan
2015), citing Leary v. Daeschner, 228 F.3d 729, 739 (6th Cir. 2000) (“the proof required for
a plaintiff to obtain a preliminary injunction is much more stringent than the proof
required to survive a dispositive motion.”); Merck Sharp & Dohme Corp. v. Conway, 2012
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1385 Filed 12/17/21 Page 12 of 35

WL 1029427, fn. 5 (E.D. Kentucky 2012) (“the standard [plaintiff must satisfy] for a
motion to dismiss is much lower than that for a motion for a preliminary injunction.”).
After reviewing the complaint and drawing all inferences in the plaintiffs’ favor,
the court may dismiss the complaint only if the plaintiffs have “failed to set forth fair
notice of what the claim is and the grounds upon which it rests that make such a claim
plausible on its face.” Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555 (2007). A
complaint will survive a motion to dismiss if it contains sufficient factual matter to state
a claim for relief that is plausible on its face and provides more than labels and
conclusions or a formulaic recitation of the elements of a cause of action. Ashcroft v.
Iqbal, 556 U.S. 662, 663 (2009). The rules do not require a probability of success but
simply “more than a mere possibility that a defendant has acted unlawfully.” Twombly,
550 U.S. at 556.
ARGUMENT
I.
WHAT LEVEL OF SCRUTINY SHOULD APPLY TO PLAINTIFFS’ CLAIMS
REMAINS AN OPEN QUESTION, BUT MSU’S VACCINE POLICY DOES NOT
EVEN SURVIVE RATIONAL BASIS REVIEW
Defendants argue that “mandatory vaccination requirements like MSU’s do not
implicate an individual’s fundamental rights and thus are constitutional so long as they
satisfy rational basis scrutiny.” See Def. MTD at 10. That there appears to be a “battle
of the experts” with respect to the degree of immunity that natural infection confers,
they argue, means that MSU has satisfied rational basis review. See id. On these grounds,
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1386 Filed 12/17/21 Page 13 of 35

they claim that there is no view of the facts on which Plaintiffs’ argument that the
University’s vaccine mandate violates their rights to bodily autonomy and to decline
medical treatment under the Ninth and Fourteenth Amendment to the United States
Constitution can survive a motion to dismiss. See Def. MTD at 10-15.
A. Whether Strict Scrutiny or Rational Basis Analysis Applies to COVID-
19 Vaccine Mandates Is Unresolved
Our nation has never before seen vaccine mandates like those now proliferating
throughout the nation, involving entirely new EUA-approved vaccines2 for a disease
that does not present a deadly threat to most people, and with such vaccines appearing
to be relatively ineffective at stopping transmission. None of the cases at hand involved
vaccines approved under an EUA, nor did they involve vaccines that had existed for
less than two years, meaning that, by definition, their long-term effects cannot be
known. There is also no prior history of widespread employer vaccine mandates such
as the one that MSU has implemented.

Jacobson v. Massachusetts was decided in 1905, at a time when interracial marriage
was illegal in many states and women did not have the right to vote at the federal level.
197 U.S. 11 (1905). Much has changed since that time, including our concept of the
importance of bodily autonomy, the right to decline medical treatment, and the science
of detecting antibodies. Plaintiffs do not ask this Court to overturn Jacobson—contrary
to Defendants’ contentions (see Def. MTD at 12)—but rather to limit it to its time and

2 See Point III.
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1387 Filed 12/17/21 Page 14 of 35

circumstances and harmonize it with more recent court precedents. We also ask this
Court to recognize the framework in which Jacobson was decided, including the fact that
it was a statute at issue (rather than an administrative edict), the lethality and nature of
the disease being considered, and the medical advancements made since 1905.
Even on its own terms, Jacobson did not purport to stand for the proposition that
all vaccine mandates are always legal. Rather, the decision made clear that there may be
circumstances in which such mandates violate constitutional rights. See Jacobson, 197
U.S. at 28 (“it might be that an acknowledged power of a local community to protect
itself against a[n] epidemic threatening the safety of all might be exercised in particular
circumstances and in reference to particular persons in such an arbitrary, unreasonable
manner, or might go so far beyond what was reasonably required for the safety of the
public, as to authorize or compel the courts to interfere for the protection of such
persons.”).
Several cases, post-dating Jacobson, confirm that not all vaccine mandates are
subject only to rational basis review. Cruzan v. Dir., Mo. Dep’t of Public Health, 497 U.S.
261, 278 (1990) explicitly stated that the Constitution protects a person’s right to
“refus[e] unwanted medical care.” See King v. Rubenstein, 825 F.3d 206, 222 (4th Cir.
2016) (recognizing same). This right is “so rooted in our history, tradition, and practice
as to require special protection under the Fourteenth Amendment.” Washington v.
Glucksberg, 521 U.S. 702, 722 n.17 (1997). The Court has explained that the right to
refuse medical care derives from the “well-established, traditional rights to bodily
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1388 Filed 12/17/21 Page 15 of 35

integrity and freedom from unwanted touching.” Vacco v. Quill, 521 U.S. 793, 807
(1997).
Given that in the last 115 years of jurisprudence and medical advancement the
courts have issued numerous decisions taking a vastly different approach to notions of
bodily integrity, at the very least this question deserves to be fully litigated to take into
consideration these developments. The claim certainly cannot properly be done away
with via a motion to dismiss. See BST Holdings, No. 21-60845 * 18 (granting preliminary
injunction because being forced to choose between vaccination and employment
entailed a loss of constitutional freedoms, even though masking and testing was offered
as an alternative to vaccination); Louisiana v. Becerra, No. 3:21-cv-03970 (“The Plaintiff
States’ citizens will suffer irreparable injury by having a substantial burden placed on
their liberty interests because they will have to choose between losing their jobs or
taking the vaccine.”); Missouri v. Biden, 2021 WL 5564501 (granting Plaintiffs’ motion to
preliminarily enjoin CMS mandate).
B. MSU’s Vaccine Directive Does Not Satisfy Rational Basis Review
The government must justify the imposition of an intrusive mandate such as the
Directive at issue here. Even if rational basis review were to apply (which it doesn’t),
MSU has not satisfied its burden. Defendants, attempting to justify their mandate,
conflate the notion of stemming the spread of COVID-19 with the threat that the virus
poses to unvaccinated individuals. Indeed, they state that “COVID-19 is still a threat
to people who are unvaccinated,” Def. MTD at 6, an implicit concession that the virus
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1389 Filed 12/17/21 Page 16 of 35

does not pose a significant danger to the vaccinated. But if COVID-19 poses a threat
only to the unvaccinated—and the vaccines protect any individual who receives them—
then there is no state interest in mandating vaccines for everyone. The government
(including a state actor like MSU) is not entitled to insert itself into our personal health
decisions, especially when those decisions affect each of us individually. To hold
otherwise would be to allow the State to wield unconstrained and unconstrainable
power over the lives of each and every one of us. Why, if the individual’s physical
health may be the subject of a mandate, should not daily exercise be required, or a
mandate for a certain amount of green vegetables consumption be implemented?
Obesity is one of the most significant risk factors for a severe COVID-19 infection, but
no serious person has suggested mandating that we all maintain a BMI below a certain
level; to even consider such a concept is ludicrous. See Roni Caryn Rabin, “The
Coronavirus Attacks Fat Tissue, Scientists Find,” The New York Times (Dec. 8, 2021).
The Missouri District Court has enjoined the federal CMS mandate, thereby
recognizing as much when it stated: “the lack of data regarding vaccination status and
transmissibility—in general—is concerning” and “CMS also admits that the continued
efficacy of the vaccine is uncertain.” See Missouri v. Biden, 2021 WL 5564501 (E.D. Mo.
Nov. 29, 2021) at 15-16. See also Bhattacharya Decl. ¶¶ 23-24 (“the evidence to date
suggests that while vaccines—like natural immunity—provide strong protection against
severe disease, they, unlike natural immunity, provide only short-lasting protection
against subsequent infection and disease spread.”).
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1390 Filed 12/17/21 Page 17 of 35

The Jacobson decision was based in part on the existence of ample proof that the
smallpox vaccine was sterilizing, meaning that it stopped or significantly slowed
transmission. See Jacobson, 197 U.S. at 32 (“the principle of vaccination as a means to
prevent the spread of smallpox has been enforced in many states” and “[i]f vaccination
strongly tends to prevent the transmission or spread of this disease, it logically follows
that children may be refused admission to the public schools until they have been
vaccinated.”). Defendants provide no such scientific evidence here. Quite the contrary.
See Missouri v. Biden, 2021 WL 5564501 (quoting CMS’s own statements acknowledging
that “the effectiveness of the vaccine to prevent disease transmission by those
vaccinated [is] not currently known.”). Their legal arguments are also premised upon
the benefit to the individual of receiving the vaccine, which again cannot be reconciled
with their claim that the justification for a mandate is danger the unvaccinated pose to
others.
It is also important to recognize that the Supreme Court requires a District Court
to exclude evidence that does not meet the Daubert criteria for reliability. Daubert v.
Merrell Dow Pharmaceuticals Inc., 509 US 579 (1993). The “science” used to assert this
vast power of forced vaccination has not been tested either at a Daubert hearing or at
trial. There are facts that, if proven, would invalidate this policy under any standard. If
naturally acquired immunity is as effective as (or more effective than) the vaccines at
halting transmission, then there is no justification for the Directive, and it cannot
survive rational basis review. Notably, Defendants do not contend that MSU’s
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1391 Filed 12/17/21 Page 18 of 35

Directive would satisfy strict scrutiny level analysis. See BST Holdings, No. 21-60845 *13
(finding Biden’s OSHA mandate “staggeringly overbroad” as, inter alia, a “a naturally
immune unvaccinated worker is presumably at less risk than an unvaccinated worker
who has never had the virus. The list goes on, but one constant remains—the Mandate
fails almost completely to address, or even respond to, much of this reality and common
sense.”); Kentucky v. Biden, No. 3:21-cv-00055 * 13 (Nov. 30, 2021) (citing as evidence
that the Biden mandate did not accomplish goals of statute through which it was
implemented that the “applies to employees of federal contractors and subcontractors
who work entirely from home and are not at risk of spreading COVID-19 to others.”).
Oddly enough, Defendants point to Plaintiffs’ statements acknowledging that
the coronavirus presents a serious threat to public health and that the vaccines are an
effective means of mitigating that danger. See Def. MTD at 12-13. Once again, this is
a conflation of two separate notions. That the vaccines are potentially effective
instruments for individuals to choose to take in order to reduce their own risk, depending on
their specific circumstances, does not mean that blanket mandates—particularly those
that do not provide exemptions for those with naturally acquired immunity—are an
effective means of addressing the crisis. Both the Missouri and Louisiana District
Courts, enjoining the CMS mandate, observed that workplace vaccine requirements
tend to be counterproductive. See Missouri v. Biden, 2021 WL 5564501 (“[b]y dispensing
with [notice and comment] requirements, CMS ignored evidence showing that the
mandate threatens devastating consequences to healthcare providers, staff, and patients
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1392 Filed 12/17/21 Page 19 of 35

throughout the nation.”); Louisiana v. Becerra, No. 3:21-CV-03970 (W.D. Louisiana 2021)
(finding that CMS mandate is arbitrary and capricious because, inter alia, implementing
statute was designed to protect patients, while the mandate is likely to result in shortages
of healthcare workers and thereby harm patients).
Defendants argue that their policy, insofar as it does not carve out an exemption
for the naturally immune, withstands rational basis level review because experts differ
as to whether individuals who have naturally acquired immunity should get the vaccine.
They do not address the fact that transmissibility seems unaffected by vaccination as
compared to naturally acquired immunity. As an initial matter this is a factual dispute,
and given that this case is at the motion to dismiss stage, any and all facts involved must
be viewed in the light most favorable to Plaintiffs. Construed in this manner, naturally
acquired immunity is equally or more protective to that achieved through vaccination.
See DirecTV, 487 F.3d 471 (“unless it appears beyond doubt that the plaintiff can prove
no set of facts in support of his claim which would entitled him to relief” and the court
must “construe the complaint in the light most favorable to the plaintiff, accept its
allegations as true, and draw all reasonable inferences in favor of the plaintiff.”).
In any event, Defendants’ position is based on a fundamental misapprehension
of a crucial issue. They confuse raised antibody levels, which may or may not translate
into a marginal clinical benefit, with justification for a mandate. True, some experts
recommend that even those who have had COVID-19 get a vaccine to boost their
antibody levels for their personal protection. But antibody levels could always be
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1393 Filed 12/17/21 Page 20 of 35

boosted—even to dangerous levels—but that does not necessarily offer more
protection, as the immune system is very complex and not limited to generation of
antibodies. See Bhattacharya Decl. ¶¶ 14. Furthermore, this is true of those who have
had the vaccine, as well. Whether the vaccine’s temporarily raising antibody levels
justifies a mandate—which involves intrusion into an individual’s personal medical
decisions—is another matter, and in fact the one in question.
Vaccination of the naturally immune may be counterproductive. Some experts
believe that subsequent vaccination (especially a two-dose regimen) for those who have
been previously infected may cause “‘exhaustion,’ and in some cases even a deletion, of
T-cells,” leading to a depleted immune response. Block Article. See Reply to
Preliminary Injunction Opposition, Attachment A, ECF No. 11-3, Reply Decl.
Hooman Noorchashm (“Reply Decl.”) ¶¶ 18-23. Combined with the documented,
heightened risk of adverse effects that those with naturally acquired immunity face,
there is a strong argument that requiring the naturally immune to receive vaccines also
entails additional violations of fundamental, constitutional rights, since vaccination could
make this subpopulation more susceptible to reinfection.
Defendants likewise misrepresent the outlier Kentucky study that the CDC has
touted as substantiating MSU’s Directive. See Def. MTD at 14. This study was wrongly
interpreted and incorrectly portrayed by the media. Contrary to Defendants’ claims,
Plaintiffs did not “admit that at least one scientific study concludes” naturally acquired
immunity is inferior to the vaccines. Rather, Plaintiffs explained why the CDC
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1394 Filed 12/17/21 Page 21 of 35

misrepresented the results of that study to reach the conclusion that it sought, including
that the CDC had data from all 50 states but released the results of the only one
(Kentucky) that could be construed as supporting its position. See FAC ¶ 136, citing
Joint Decl. ¶ 37, Noorchashm Decl. ¶¶ 29-31, Bhattacharya Decl. ¶¶ 47-48. See also
Marty Makary, “Covid Confusion at the CDC,” The Wall Street Journal (Sept. 13, 2021),
available
at
https://www.wsj.com/articles/covid-19-coronavirus-breakthrough-
vaccine-natural-immunity-cdc-fauci-biden-failure-11631548306 (last visited Nov. 3,
2021.) Furthermore, the study “did not address or attempt to quantify the magnitude
of risk and adverse effects in its comparison groups,” Noorchashm Decl. ¶¶ 29-31, as
the study did not compare vaccinated individuals to COVID-recovered individuals. It
also did not control for the fact that the vaccinated are “possibly less likely to get tested.
Therefore, the association of reinfection and lack of vaccination might be
overestimated.” Block article.

In a similar sleight of hand, Defendants argue that “Plaintiffs concede that
they lack certainty that they will not transmit the virus to others,” to justify their vaccine
mandate. Def. MTD at 14. Of course Plaintiffs lack total certainty. Even if they were
vaccinated, both they and the CDC would still lack certainty that they were unable to
become infected and transmit the virus. Little, if anything, in science or medicine is
certain. Defendants cannot claim that those who have been vaccinated will definitely
not transmit the virus, and as the real-world evidence is showing, precisely the opposite
appears to be true: vaccinated people are spreading the virus, as even the CDC
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1395 Filed 12/17/21 Page 22 of 35

acknowledges. See, e.g., “Delta Variant: What We Know About the Science,” CDC
(Aug.
26,
2021),
available
at
https://www.cdc.gov/coronavirus/2019-
ncov/variants/delta-variant.html (last viewed Dec. 15, 2021) (“[f]ully vaccinated people
with Delta variant breakthrough infections can spread the virus to others.”). At the
same time, it has no record of those with natural immunity doing so. See Ex. A.
Every day, the evidence establishing the robustness and durability of naturally
acquired immunity, and relative inferiority of vaccine-induced immunity (hence the
discussion of a fourth round of shots), grows. All real-world evidence points to the fact
that naturally immune people only become reinfected on extremely rare occasions and
do not transmit the virus. The so-called evidence that naturally immune people should
receive the vaccine is at best theoretical, and not borne out by real world observations.
See Ex. A. See also, e.g., Bhattacharya Decl. ¶ 16 (citing a study from Israel of 6.4 million
individuals, in which half a percent of those with naturally acquired immunity were
reinfected, much less than reinfections among the vaccinated).
Accordingly, even if rational basis review applies, MSU’s policy cannot survive it. See
Paul Elias Alexander, “137 Research Studies Affirm Naturally Acquired Immunity to
Covid-19,”
Brownstone
Institute
(Oct.
17,
2021),
available
at
https://brownstone.org/articles/79-research-studies-affirm-naturally-acquired-
immunity-to-covid-19-documented-linked-and-quoted/ (last viewed Dec. 15, 2021).
Plaintiffs have, in fact, “negate[d] every conceivable basis which might support” MSU’s
policy. The approach that MSU has taken means that the university could mandate the
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1396 Filed 12/17/21 Page 23 of 35

vaccine for each employee every day—because it would boost their antibody levels. At
the very least, the question warrants further litigation and cannot be resolved at this
stage.
II.
CONTRARY TO DEFENDANTS’ CLAIMS, MSU’S VACCINE DIRECTIVE
CONSTITUTES AN UNCONSTITUTIONAL CONDITION
Defendants’ arguments on this point are based on a misunderstanding or
misportrayal of various aspects of unconstitutional conditions doctrine. See Def. MTD
at 15-16. They contend that Plaintiffs’ claims fail because: (1) they have failed to identify
an enumerated right that the vaccine policy coerces them into giving up;
(2) they have not established that they are being coerced into surrendering rights that
the law deems fundamental or any rights at all; and (3) they have not alleged facts giving
rise to an inference of coercion. All these arguments rest upon flawed premises.
A. Plaintiffs Do Not Have to Allege Violation of an Enumerated Right
in Order to Succeed on this Claim
As established by Memorial Hosp. v. Maricopa Cty, 415 U.S. 250 (1974), the right
that Plaintiffs allege MSU’s Directive violates need not be enumerated in the United
States Constitution. In Maricopa, the right in question was that to interstate travel,
alleged under the Fourteenth Amendment—unquestionably not a specifically
enumerated right. Defendants simply ignore the existence of this case, presumably
because it cannot be reconciled with their contentions.
Instead, their claims rest on Koontz v. St. Johns River Water Mgmt. Dist., 579 U.S.
595, 604 (2013), in which the Court stated that Maricopa County and other cases “reflect
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1397 Filed 12/17/21 Page 24 of 35

an overarching principle, known as the unconstitutional conditions doctrine, that
vindicates the Constitution’s enumerated rights by preventing the government from
coercing people into giving them up.” Nowhere in Koontz does the Court state that the
right in question must be enumerated. There is no reason to believe that in Koontz the
Court intended to overrule Maricopa County. The two should thus be read together,
yielding the result that while the right that is leveraged may be enumerated, it does not
have to be. See also Regan v. Taxation With Representation of Wash., 461 U.S. 540, 454 (1983)
(“the government may not deny a benefit to a person because he exercises a constitutional
right.”) (emphasis added); R.S.W.W. v. City of Keego Harbor, 397 F.3d 427, 434
(2005)((“[unconstitutional conditions] doctrine should equally apply to prohibit the
government from conditioning benefits on a citizen’s agreement to surrender due
process rights.”).
B. Constitutional Rights Are at Issue Here
Defendants’ contention that no constitutional rights are at issue fares no better.
Plaintiffs acknowledge that whether the rights in question—to decline medical
treatment and to protect bodily integrity when one has naturally acquired immunity to
the disease in question—are fundamental is a live one. But even this Court, in denying
the motion for a preliminary injunction, acknowledged that Plaintiffs possessed those
rights. It held that vaccination did not implicate a fundamental right. See Norris v. Stanley,
__F.3d.___, 2021 WL 3891615 (W.D. Michigan 2021). See also BST Holdings, No. 21-
60845 * 18 (finding that Plaintiffs’ constitutional rights were implicated by OSHA
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1398 Filed 12/17/21 Page 25 of 35

vaccine requirement and thereby staying it); Louisiana v. Becerra, No. 3:21-cv-03970
(“The Plaintiff States’ citizens will suffer irreparable injury by having a substantial
burden placed on their liberty interests because they will have to choose between losing
their jobs or taking the vaccine.”).
This case also raises the specific question of whether vaccinating the naturally
immune constitutes a violation of those constitutional rights, since there is no
compelling government interest and vaccination presents a heightened risk of harm to
the COVID-19 recovered. See supra at 9-13. If factual inferences are made in Plaintiffs’
favor—in particular that naturally acquired immunity is on par with or superior to that
induced through vaccination—then the outcome of the case may be different.
Moreover, these mandates involve new vaccines that are only EUA approved, unlike
any other mandate in our nation’s history. See infra, Point III. Certainly, the lack of
knowledge as to long-term effects the vaccines could have ought to play a role in the
propriety—or legality—of mandating them.
C. MSU’s Policy Is Coercive Under Unconstitutional Conditions Doctrine
Perhaps Defendants are so fortunate and well off that the threat of job loss (and
commensurate income deficit) would not constitute coercion for them. But for the
average American, the prospect is so grim that they will avoid it at all costs, including
yielding their rights to bodily integrity and receiving a medically unnecessary and
possibly harmful vaccine. The coercion here is no less than it was in Maricopa County,
in which the loss the plaintiffs were threatened with was that to interstate travel.
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1399 Filed 12/17/21 Page 26 of 35

Moreover, in several recent cases involving vaccine mandates, courts have found
that being forced to choose between vaccination and employment constitutes
irreparable harm, an implicit acknowledgment that such polices are coercive. See BST
Holdings, No. 21-60845 * 18 (granting preliminary injunction because the OSHA
mandate “substantially burden[s] the liberty interests of reluctant individual recipients
put to a choice between their job(s) and their jab(s)” which constituted a loss of
constitutional freedoms and thereby irreparable injury.”); see also Fraternal Order of Police
Chicago Lodge No. 7, et al. v. City of Chicago, Case No. 2021 CH 5276, at 3 (Circuit Court
of Cook County, Ill.)(Nov. 1, 2021)(internal citations omitted), available at
https://news.wttw.com/sites/default/files/article/file-
attachments/FOP%20v.%20City%20of%20Chicago%2011.1.21%20Order.pdf
(last
visited Nov. 3, 2021) (“An award of back pay or reinstatement cannot undo a vaccine.
Nothing can. … An award in favor of the police unions would be an ‘empty victory.’
‘Obey now, grieve later’ would be transformed into ‘obey now and forever’ without a
meaningful opportunity to arbitrate.”).
Indeed, an unconstitutional conditions claim may be predicated upon denial of a
benefit as opposed to the threat of a loss. See Koontz, 570 U.S. at 604 (“the government
may not deny a benefit to a person because he exercises a constitutional right.”); Speiser
v. Randall, 357 U.S. 513, 518 (1958) (holding that government created unconstitutional
condition by denying property tax exemption for engaging in certain speech). Thus,
assuming arguendo that employment at MSU is merely a benefit—a point that Plaintiffs
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1400 Filed 12/17/21 Page 27 of 35

do not concede—that benefit may nonetheless serve as the basis for an unconstitutional
conditions claim.
In short, dismissal of Plaintiffs’ unconstitutional conditions claim is not
appropriate.
III.
MSU’S VACCINE MANDATE IS PREEMPTED BY FEDERAL LAW
A. Plaintiffs Are Entitled to Bring Claims for Declaratory and Injunctive
Relief Under 21 U.S.C. § 360bbb-3 for Violations of Their Statutory Rights
to Informed Consent
Defendants cite two cases to support the proposition that the EUA statute does
not provide a private right of action, but only empowers the Secretary of the
Department of Health and Human Services to enforce informed consent. Def. MTD
at 18-19. Initially, Defendants’ cited cases are from the Northern District of Indiana
(Klaassen v. Board of Trustees, 2021 WL 3073926 (July 18, 2021)) and Southern District of
Texas (Bridges v. Houston Methodist Hospital, No. H-21-1774, 2021 WL 239994 at *2 (S.D.
Tex. June 12, 2021)), neither of which carries precedential weight in this jurisdiction.
In any event, both Defendants’ arguments and Klassen and Bridges are based on a
fundamental misapprehension of the legal principles at stake.
Plaintiffs acknowledge that 21 U.S.C. § 360bbb-3 does not expressly provide for
a private cause of action. Nothing in the part of the statute to which Defendants point,
however, suggests that Congress intended to preclude individuals from enforcing their
statutory rights not to take an EUA treatment. See 21 U.S.C. § 360bbb-3(e)(1)(A)(ii).
True, “private right of action” may not be the correct terminology for this situation.
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1401 Filed 12/17/21 Page 28 of 35

Nevertheless, Plaintiffs may seek injunctive relief to cease the violation of their rights
to informed consent under 21 U.S.C. § 360bbb-3. The right to informed consent
necessarily resides with the person receiving the treatment. The EUA statute does not
give that right to anyone except those who already have it, in this case, Plaintiffs.
The Supreme Court has unequivocally established that the Supremacy Clause
permits individuals to seek injunctive relief in federal court against state officers in order
to prevent enforcement of state laws that are preempted by federal statutes. See
Armstrong v. Exceptional Child Center, 575 U.S. 320m 326 (2015), citing Ex parte Young, 209
U.S. 123, 155-56 (1908) (“if an individual claims federal law immunizes him from state
regulation, the court may issue an injunction upon finding the state regulatory actions
preempted.”). See also Crosby v. National Foreign Trade Council, 530 U.S. 363 (2000)
(granting plaintiffs injunctive relief, even though federal statute that allegedly preempted
state law did not create a provide right of action and so was probably not enforceable
under § 1983). Cf. Gonzaga Univ. v. Doe, 536 U.S. 273, 282 (2002) (requiring “an
unambiguously conferred right to support a cause of action brought under § 1983” for
damages); Board of Trustees v. Garrett, 531 U.S. 356 (2001) (noting that Rehnquist Court
limited Congress’s power to create a damages remedy for private plaintiffs to sue state
governments for violations of federal statutes).3

3 Even the result-oriented and flawed OLC Opinion does not take the position that citizens may not
contest their claims in court.
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1402 Filed 12/17/21 Page 29 of 35

In any event, as the question has not been determined by a high court—both
whether the statute allows individuals to sue for injunctive and declaratory relief under
it and whether employers may mandate EUA vaccines—at the very least it is unsettled.
Accordingly, dismissal of this count at this stage would be inappropriate.
Relatedly, and contrary to Defendants’ position, see Def. MTD at 19, Klaassen’s
determination that “the informed consent requirement under the EUA statute only
applies to medical providers,” see 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)), cannot be an
accurate reading of the statute. Informed consent is an utterly hollow concept if
employers can premise continued employment upon taking the product in question,
and there is no evidence whatsoever that Congress intended for any employer—and
certainly not governmental ones—to be able to circumvent the informed consent
requirement. See BST Holdings, No. 21-60845 * 18 (mandate “substantially burden[s]
the liberty interests of reluctant individual recipients put to a choice between their job(s)
and their jab(s)”.).
At a minimum, and given the lack of precedent, as the question has never been
addressed by courts higher than the district level, it cannot be decided at the motion to
dismiss stage, at which all factual inferences are to be made in Plaintiffs’ favor.
B. None of the Vaccines Actually Available for Intake Has Received Full
FDA Approval
Defendants contend that MSU employees are not required to take EUA vaccines
in order to maintain employment because the Pfizer Comirnaty has received full FDA
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1403 Filed 12/17/21 Page 30 of 35

approval. They claim that Plaintiffs admit Comirnaty and BioNTech have the same
formulation. See Def. MTD at 20.
In actuality, Plaintiffs acknowledge nothing more than that the FDA fact sheet
stated that the two could be used interchangeably. Since submitting the FAC, more
information (recognized by a federal court) has become available indicating that the
Comirnaty and BioNTech are not, in fact, the same. To begin, Pfizer acknowledges
that the two vaccines are “legally distinct,” and a federal court has concluded that the
Comirnaty and BioNTech vaccines are not interchangeable “as a matter of law,” Order
Denying Preliminary Injunction Motions, John Doe v. Austin, Case No. 3:21-cv-01211,
Doc. No. 47 at 14, (N.D. Fl., Nov. 12, 2021) (concluding that BioNTech vaccines
“remain ‘product[s] authorized for emergency use under section 564 of the Federal
Food, Drug, and Cosmetic Act.’”) (quoting 10 U.S.C. § 1107a(a)(1)).
The two vaccines contain a different number of ingredients: Comirnaty has
eleven (11) ingredients while Pfizer-BioNTech has just ten (10) ingredients. FDA,
Vaccine Information Fact Sheet for Recipients and Caregivers about COMIRNATY
(COVID-19 Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine to Prevent
Coronavirus
Disease
2019
(COVID-19)
(Aug.
23,
2021),
available
at
https://www.fda.gov/media/151733/download (last viewed Dec. 15, 2021).

The claim that the two vaccines are interchangeable comes from a Guidance
document, which does not carry force of law. See Christensen v. Harris County, 529 U.S.
576, 587-88 (2000) (“Interpretations such as those in opinion letters—like
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1404 Filed 12/17/21 Page 31 of 35

interpretations contained in policy statements, agency manuals, and enforcement
guidelines, all of which lack the force of law—do not warrant Chevron-style deference.”);
Appalachian Power v. EPA, 208 F.3d 1015, 1028 (D.C. Cir. 2000) (guidance documents
that agencies treat as de facto law are void because they did not run the notice-and-
comment gauntlet) (setting aside an agency guidance document in its entirety). In any
event, this “fact” must be determined at a subsequent stage, not at the motion-to-
dismiss stage.
FDA cannot convert a legally distinct product that is available (the BioNTech
vaccine) into a fully approved vaccine (Comirnaty) that is impossible to acquire. FDA,
via a mere guidance document, is attempting to establish equivalence between what are
two legally distinct vaccines. That is improper as a general matter of administrative law.
It is yet more improper since it is a maneuver designed to override federal statutory
rights to informed medical consent and to refuse EUA products.
It was also recognized in Doe v. Austin, which explained that even medical
products FDA claims are interchangeable can contain different inactive ingredients,
which can impact safety and effectiveness of the drug in question. Austin, 3:21-cv-
01211 at 7 fn. 5, citing United States v. Generix Drug Corp., 460 U.S. 453, 454-55 (1983).
Defendants cannot be permitted to rely on mere FDA-issued guidance
documents, especially where doing so would vitiate clear statutory rights. Moreover,
specifically referring to the Comirnaty Vaccine, Pfizer has admitted that there “is not
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1405 Filed 12/17/21 Page 32 of 35

sufficient approved vaccine available for distribution to this population in its entirety at
the time of the reissuance of this EUA.”
Indeed, the Task Force Guidance governing the federal mandate warns that
meeting the deadlines rests exclusively on the shoulders of the employees, availability
problems being no excuse at that point: “Depending on employees’ locations, they may
not have all types of vaccines available to them. Agencies should encourage employees
to plan ahead and allow enough time to receive all required vaccine doses before the
November 8 deadline to have their second shot.” Id. Since the Comirnaty Vaccine,
being the only fully FDA-approved vaccine, is not widely available, and certainly is not
available to all members of the population including Plaintiffs, nor is the legally distinct
BioNTech, the EUA statute’s sphere of operation continues to apply. Accordingly,
MSU employees are effectively being coerced into taking an EUA vaccine in violation
of the statute’s informed consent provision.
IV.
PLAINTIFFS CITED HUMAN RIGHTS LAW AS A SOURCE OF GUIDANCE, NOT
AS A CAUSE OF ACTION
Defendants argue that Plaintiffs’ alleged violations of various international
treaties should be dismissed because these laws do not provide for a private right of
action. See Def. MTD at 21. Plaintiffs did not cite to these treaties to suggest that they
were bringing claims under them. Rather, the purpose was to establish that MSU’s
vaccine policy, like those metastasizing throughout the nation, violate various principles
of human rights law and are not in accord with constitutional or international norms.
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1406 Filed 12/17/21 Page 33 of 35

CONCLUSION
MSU’s vaccine mandate violates Plaintiffs’ constitutional and statutory rights and
creates an unconstitutional condition. While Plaintiffs are confident that after fully
litigating the case they will prevail, certainly making all factual inferences in their favor
militates against Defendants’ Motion to Dismiss. This Court should deny Defendants’
Motion to Dismiss and allow Plaintiffs to prosecute their claims.

Dated: December 17, 2021

Respectfully submitted,

/s/ Jenin Younes
JENIN YOUNES
Litigation Counsel
Admitted in this Court
HARRIET HAGEMAN
Senior Litigation Counsel
Admitted in this Court
JOHN VECCHIONE
Senior Litigation Counsel
Admitted in this Court
NEW CIVIL LIBERTIES ALLIANCE
1225 19th Street NW, Suite 450
Washington, DC 20036
(202) 869-5210

Counsel to Plaintiffs
Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1407 Filed 12/17/21 Page 34 of 35

CERTIFICATE OF COMPLIANCE

I certify that this document complies with the word limited within LCivR
7.2(b)(i) because, excluding the parts of the document exempted by that rule, this
document contains 7,361 words, according to the word count function of Microsoft
Word for Office 365.

Dated: December 17, 2021

s/ Jenin Younes
JENIN YOUNES
Litigation Counsel

Case 1:21-cv-00756-PLM-SJB ECF No. 62, PageID.1408 Filed 12/17/21 Page 35 of 35

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Plaintiffs' Opposition to Motion to Dismiss — Norris v. Stanley

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