Klaassen et al v. The Trustees of Indiana University
OPINION AND ORDER: The court DENIES the 7 preliminary injunction motion. Signed by Judge Damon R Leichty on 7/18/2021. (dk)
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UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF INDIANA
SOUTH BEND DIVISION
RYAN KLAASSEN et al.,
CAUSE NO. 1:21-CV-238 DRL
THE TRUSTEES OF INDIANA
OPINION & ORDER
Under guiding principles of federalism, our Constitution preserves the power of
the States, within constitutional limits, to adopt laws to provide for public health and
safety. Twice the United States Supreme Court has upheld state authority to compel
reasonable vaccinations. The States don’t have arbitrary power, but they have discretion
to act reasonably in protecting the public’s health.
Students at Indiana University have a significant liberty protected by the
Constitution—refusing unwanted medical treatment based on bodily autonomy. The
Fourteenth Amendment says no state may “deprive any person of life, liberty, or
property, without due process of law.” U.S. Const. amend. XIV § 1. Given this due process
protection of liberty, longstanding constitutional law prevents a public university—an
arm of the State—from mandating a vaccine for its students unless it has rationally
pursued a legitimate interest in public health for its campus community.
This case presents that question: whether Indiana University has acted
constitutionally in mandating the COVID-19 vaccine for its students, as announced on
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May 21, 2021. Albeit, and this should not be overlooked, this case does so only in the
context of a preliminary injunction motion, not for a final decision on the merits.
Indiana University’s policy has real implications. Students may be deprived of
attending the university without being vaccinated or qualifying for an exemption. Still
they have real options—taking the vaccine, applying for a religious exemption, applying
for a medical exemption, applying for a medical deferral, taking a semester off, or
attending another university or online. The policy applies for the fall 2021 semester only.
Eight students sued Indiana University because of its vaccination mandate and
because of the extra requirements of masking, testing, and social distancing that apply to
those who receive an exemption. They ask the court to enter a preliminary injunction—
an extraordinary remedy that requires a strong showing that they will likely succeed on
the merits of their claims, that they will sustain irreparable harm, and that the balance of
harms and the public interest favor such a remedy.
The court now denies their motion. The Constitution and longstanding precedent
should endure. Recognizing the students’ significant liberty to refuse unwanted medical
treatment, the Fourteenth Amendment permits Indiana University to pursue a
reasonable and due process of vaccination in the legitimate interest of public health for
its students, faculty, and staff. Today, on this preliminary record, the university has done
so for its campus communities. The students haven’t established a likelihood of success
on the merits of their Fourteenth Amendment claim or the many requirements that must
precede the extraordinary remedy of a preliminary injunction.
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Indiana University is a world-renowned public research university, with seven
campuses, two regional centers, and three medical centers across the State of Indiana,
providing education to over 90,000 undergraduate and graduate students and
employment for over 40,000 employees [Ex. 116 ¶ 4]. The university, with its flagship
campus in Bloomington, Indiana home to over 40,000 students, continually ranks as one
of the top 100 universities in the country, and one of the top 150 universities in the world.
The eight students here have varied backgrounds. Jaime Carini (age 39) is a
graduate student pursuing two doctorates in music, with but her examinations and
dissertation to complete [Ex. 121 at 10, 19-20, 23]. She has received an exemption from the
university’s vaccination requirement already [id. 57-58].
Ashlee Morris (age 26) is an incoming first year law student at the McKinney
School of Law who has worked hard for six years to get there to pursue her J.D. [Ex. 123
at 10, 66-67]. She too has received a religious exemption from the university’s vaccination
requirement [id. 44]. She testifies that she will not attend the law school if she must wear
a mask or undergo surveillance testing [id. 66-67].
Seth Crowder (age unknown) is pursuing his MBA at the Kelley School of Business
[Ex. 124 at 13]. He too has received a religious exemption from the university’s
vaccination requirement already [id. 9, 20-21]. He has not decided if he will return to
school if he must wear a mask or undergo surveillance testing this fall semester [id. 42].
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Macey Policka (age 22) is a senior at Indiana University studying English
(medieval studies) [Ex. 125 at 8-9]. She also has received a religious exemption from the
university’s vaccination requirement [id. 22]. She plans to return to Indiana University
regardless of the outcome of this case [id. 36-37]
Ryan Klaassen (age 19) is an incoming sophomore at Indiana University studying
biochemistry [Ex. 120 at 5, 15-17]. He has received a religious exemption to the
university’s vaccination requirement [id. 33]. He says he hasn’t decided if he will return
to Indiana University if the injunction is not granted. [id. 41-43].
Daniel Baumgartner (age 18) is an incoming freshman at Indiana University who
plans to study business [Ex. 122 at 8, 12-13]. He has received a religious exemption to the
university’s vaccination requirement [id. 8]. He has not decided if he will go to Indiana
University this fall if he must wear a mask or undergo surveillance testing [id. 41].
Margaret Roth (age unknown) is an incoming freshman at Indiana University and
has already registered for classes [Ex. 126 at 9, 20]. She has a religious objection to the
vaccine but has not requested an exemption, though she would qualify, because she
prefers not to wear a mask or undergo testing [id. 45-47]. She says she will most likely not
attend Indiana University if the injunction isn’t granted [id. 9].
Natalie Sperazza (age unknown) is an incoming sophomore who will be taking
five classes this fall [Ex. 127 at 11]. She has not applied for an exemption and believes she
wouldn’t qualify [id. 15-16]. She says she will not attend Indiana University this fall if the
policy remains in place [id. 42]. She appears to be the only student without an exemption
or basis for an exemption.
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COVID-19 is an infectious disease caused by the novel coronavirus. It primarily
spreads through respiratory droplets, viral particles suspended in the air, and touching
mucosal membranes with contaminated hands [Ex. 115 ¶ 6].1 The initial presentation of
an infection ranges from no symptoms at all (asymptomatic) to severe illness and death;
and even after recovery, various long-term health problems may linger [id. ¶ 8].2
Individuals with longstanding systemic health inequities or preexisting or
immunocompromising conditions, and elderly individuals prove at greater risk of severe
illness or hospitalization following an infection [id. ¶ 9].3 Children and young adults are
less likely to experience serious illness or death from infection [Ex. 115 ¶ 10; Ex. 117 ¶ 21].
Though data from the Centers for Disease Control and Prevention (CDC) suggest that
more young adults are becoming infected with the virus than other age groups [Ex. 115
¶ 16],4 these individuals are less likely to require hospitalization or die [id. ¶ 10].5
See also Ctrs. for Disease Control & Prevention (CDC), Scientific Brief: SARS-CoV2 Transmission,
See also CDC, People with Certain Medical Conditions, https://www.cdc.gov/coronavirus/2019-ncov/needextra-precautions/people-with-medical-conditions.html (last visited July 18, 2021); Neal M. Dixit et al.,
Post-Acute COVID-19 Syndrome and the Cardiovascular System: What is Known?, 5 Am. Heart. J. Plus. 100025
(May 2021), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8223036/.
See also CDC, People with Certain Medical Conditions, https://www.cdc.gov/coronavirus/2019-ncov/needextra-precautions/people-with-medical-conditions.html (last visited July 18, 2021).
Of the total reported cases, those reported from the 18-29 age group account for 22.5 percent of all
infections—the highest proportion of any age group—despite accounting for only 16.4 percent of the
United States population. See CDC, Demographic Trends of COVID-19 Cases and Deaths in the U.S. Reported to
CDC, https://covid.cdc.gov/covid-data-tracker/#demographics (last visited July 18, 2021).
5 See also CDC, Risk for COVID-19 Infection, Hospitalization and Death by Age (Updated June 24, 2021),
https://www.cdc.gov/coronavirus/2019-ncov/covid-data/investigations-discovery/hospitalizationdeath-by-age.html (last visited July 18, 2021) (individuals aged 30-49 twice as likely to be hospitalized,
individuals 50-64 four times as likely to be hospitalized, individuals aged 30-39 four times as likely to die,
individuals 40-49 ten times as likely to die, individuals 50-64 thirty-five times as likely to die). The most
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Worldwide COVID-19 has infected almost 189 million people and caused 4 million
deaths, with these numbers still changing daily.6 In the United States, the novel
coronavirus has infected over 33.5 million citizens, losing to death over 600,000 [Ex. 115
¶ 15]. Since March 6, 2020, Indiana has had over 750,000 confirmed COVID-19 cases and
over 13,000 deaths [id. ¶ 14]. The COVID winter of 2020-2021 was particularly rough,
until vaccines became options first in December 2020 and then in the early months of
As vaccination now increases, data gathered by the CDC point toward the waning
of new COVID infections across the country—down from a peak of 312,325 new cases
reported on January 8, 2021, with a seven-day average positive test rate of 13.85 percent,
to 39,719 new cases reported on July 16, 2021, with a seven-day average positive test rate
of 5.01 percent.7 The rate of new cases today is akin, if not greater, to the rate of new cases
reported during the peak of the pandemic’s first wave in the spring 2020, through the
relative rate of positive tests thankfully remains much lower.8
Our nation has come a long way since the darker days of 2020 that tested many
people, though some uncertainty persists even now in this 2021 summer. The current
recent CDC figures suggest that only 0.04 percent of cases from this age group result in death, and this
group represents only 0.5 percent of all COVID deaths. CDC, Demographic Trends of COVID-19 Cases and
Deaths in the U.S. Reported to CDC, https://covid.cdc.gov/covid-data-tracker/#demographics (last visited
July 18, 2021) (6,174,415 individuals aged 18-29 contracted the virus, and 2,732 individuals died).
See CDC, Global Cumulative Cases of COVID-19 Reported (July 18, 2021), https://covid.cdc.gov/covid-datatracker/#global-counts-rates (citing World Health Organization (WHO), WHO Coronavirus (COVID-19)
Dashboard (July 16, 2021), https://covid19.who.int/).
7 CDC, COVID Data Tracker, https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases (last
visited July 18, 2021).
8 Id. (35,080 new cases reported on April 9, 2020, with a seven-day average positive test rate of 20.43
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seven-day moving averages of new COVID-19 cases has increased by 69.3 percent in the
past week alone; the positive test rate has increased by 40.7 percent; and new hospital
admissions have increased by 35.8 percent.9 Recalling the bell curves we all have become
accustomed to seeing, the trend still proves sharply down from the worse days of
COVID-19, but virulent and highly transmissible variants of this coronavirus present new
challenges [Ex. 115 ¶ 36]. As of July 3, 2021, the CDC estimates that 57.6 percent of new
cases come from the Delta variant.10 New COVID-19 cases often originate in unvaccinated
individuals [Ex. 115 ¶ 38-39].
In Indiana, 561 new cases were reported on July 15, 2021; and the most recent data
suggest a seven-day average positive test rate of 4.3 percent for unique individuals from
July 3, 2021 to July 9, 2021, lower than the national average.11 Of all positive cases, 18.4
percent, the highest proportion of all age populations, comes from young adults aged 2029.11 In Indiana, approximately 67.3 percent of all cases came from the Delta variant.12
Our country and our state have vastly improved, but challenges remain.
Indiana University Board of Trustees.
The Indiana General Assembly endows the Indiana University Board of Trustees
with the responsibility to fulfill its powers and duties under the law. Ind. Code § 21-27
CDC, COVID Data Tracker Weekly Review (July 16, 2021) https://www.cdc.gov/coronavirus/2019ncov/covid-data/covidview/index.html.
Id.; see also CDC, COVID Data Tracker, https://covid.cdc.gov/covid-data-tracker/#variant-proportions
(last visited July 18, 2021).
Indiana State Department of Health, COVID Dashboard, https://www.coronavirus.in.gov/2393.htm (last
visited July 18, 2021).
Indiana State Department of Health, COVID Dashboard, https://www.coronavirus.in.gov/2393.htm (last
visited July 18, 2021).
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2-1. The Trustees may pass all bylaws necessary to put into effect its powers. Ind. Code.
§ 21-27-4-3. The Trustees may set conditions and standards for admission that are in the
“best interests of the state and the state educational institution.” Ind. Code § 21-40-3-1(b).
Among these powers, the Trustees may govern “the conduct of the state
educational institution’s students, faculty, and employees, wherever the conduct might
occur, to prevent unlawful or objectionable acts that . . . violate the reasonable rules and
standards of the [university] designed to protect the academic community from . . . a
serious threat to person or property of the academic community.” Ind. Code § 21-39-23(b). The university remains answerable to the legislature, particularly its funding.
State Law on Vaccines.
Indiana requires all public university students to be vaccinated for diphtheria,
tetanus, measles, mumps, rubella, and meningococcal disease before attending school.
Ind. Code § 21-40-5-2. All but one of these vaccinations have been required since 1993.
Outside these state-mandated vaccines, Indiana University has had a policy for managing
infectious and communicable diseases since at least 2015 designed to take “reasonable
measures to ensure the safety of members of the university community during global and
local infectious disease events” [Ex. 229]. Students must report vaccination status, save
for religious and medical exemptions, including any “contraindication to a vaccine” [id.].
This reporting occurs according to state law and recommendations from the CDC’s
Advisory Committee on Immunization Practices. See Ind. Code. § 21-40-5-2.
Since this pandemic’s advent, many states have considered bills that would
prohibit either vaccine “mandates” or vaccine “passports.” For instance, just last week
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the State of Ohio passed a law banning public vaccine mandates. See 2021 Bill Text OH
H.B. 244, Sec. 3792.04(B)(1) (signed July 14, 2021). Other states have more reservedly
passed laws that would prohibit just having to show proof of COVID-19 vaccination—
hence the term COVID-19 passport. Indiana’s General Assembly recently enacted law
that prohibits a vaccine passport, not a vaccine requirement.13 Ind. Code § 16-39-11-5.
Vaccine Guidance for Institutions of Higher Education.
Governmental agencies and collegiate associations have with one chorus
promoted vaccination to address the COVID-19 pandemic, though they typically have
remained silent on whether universities should mandate a vaccine. Today more than 500
colleges and universities have mandated vaccination, though many are private
institutions of higher learning, not public universities.14
The CDC recommends that institutions of higher learning (IHEs) “can return to
full capacity in-person learning, without requiring or recommending masking or physical
distancing” only when “all students, faculty, and staff are fully vaccinated prior to the
start of the semester.”15 The Indiana State Department of Health aligns with the CDC.16
This statute applies to “the state or a local unit.” Ind. Code § 16-39-11-5(a). The students withdrew their
claim under this law because the statute omits a private right of action, leaving enforcement to the Indiana
State Department of Health. See, e.g., Ind. Code § 16-19-3-18. For sake of clarity, the court never reaches the
point whether this anti-passport law applies to a public university or not.
See Andy Thomason & Brian O’Leary, Here’s a List of Colleges That Will Require Students or Employees to Be
Vaccinated Against Covid-19, The Chronicle of Higher Education (July 15, 2021),
https://www.chronicle.com/blogs/live-coronavirus-updates/heres-a-list-of-colleges-that-will-requirestudents-to-be-vaccinated-against-covid-19?cid2=gen_login_refresh (“The Chronicle has so far identified
583 such campuses.”).
CDC, Guidance for Institutions of Higher Education (IHEs) (June 4, 2021),
ISDH, Public Resources: Back to
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Likewise citing the CDC, the United States Department of Education has said “IHEs
where everyone is fully vaccinated can return to full capacity in-person learning without
requiring or recommending masking, physical distancing, or screening testing.”17 The
American College Health Association has recommended that institutions require
COVID-19 vaccinations for all on-campus students for the fall semester.18
Indiana University’s Vaccine Mandate.
Acting under state authority, see Ind. Code § 21-38-3-4, and with the vision of
promoting public health and restoring the educational and social environment of the
university’s campuses, President Michael McRobbie created a university restart
committee during the spring of 2021 to make recommendations to the Board of Trustees
for the fall semester [Ex. 104 at 5; Ex. 116 ¶ 22]. The restart committee’s charge was to
advise and recommend requirements necessary to resume “normal face-to-face”
operations [Ex. 116 ¶ 22].
Indiana University’s Executive Vice President for University Clinical Affairs and
the School of Medicine’s Dean spearheaded the restart committee [id. ¶ 23]. It included
fifteen members with expertise in public health, epidemiology, virology, data modeling
and monitoring, risk mitigation, health equity, health sciences, and law [id.; Ex. 300 at 4-
U.S. Dept. of Educ., ED COVID-19 Handbook, Volume 3: Strategies for Safe Operation and Addressing the
Impact of COVID-19 on Higher Education Students, Faculty, and Staff 9 (June 2021),
Am. College Health Ass’n, American College Health Association Recommends COVID-19 Vaccination
Requirements for All On-Campus College Students in Fall 2021 (April 29, 2021),
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5]. The committee consisted of seven MDs, some with additional degrees in public health
or other PhDs, and others with graduate degrees in public health, risk mitigation, law,
and ethics [Ex. 300 at 5].
The restart committee met regularly to review the university’s campus population
and experiences from the 2020-2021 year, as well as “guidelines from the CDC, IU Health,
the ISDH, the Indiana Governor’s Office, and the Central Indiana Corporate Partnership,
among others,” “scientific literature and data, including COVID-19 case and
hospitalization rates for Indiana,” and “input from other Indiana and out-of-state IHEs”
[Ex. 116 ¶¶ 24-26]. The data considered by the restart committee were vast [Exs. 302-317,
PowerPoint presentations from December 8, 2020 to April 6, 2021); see also Ex. 301 ¶ 2].
Four MDs from this committee presented near-weekly from December 2020 to
June 2021 to Indiana University’s Executive Academic Leadership Council, including the
President and Executive Vice Presidents as part of the medical response team’s ongoing
COVID-19 evaluation efforts [Ex. 301 ¶ 4]. The Board of Trustees adopted the restart
committee’s recommendations for the 2021 fall semester [Ex. 116 ¶ 29].
The aim was short and strategic—vaccinate everyone, subject to certain
exemptions [id. ¶ 31; Exs. 101, 300]. Initially, the policy required all students, faculty, and
staff to submit proof of vaccination before returning to campus, but the university revised
this requirement after Indiana passed its anti-passport law [Ex. 101]. The policy today
requires all students, faculty, and staff to be fully vaccinated, which the university defines
as being two weeks post the second dose of the Pfizer and Moderna vaccines, or two
weeks post the single dose of the Johnson & Johnson vaccine, before returning to campus
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between August 1 to August 15 for the fall 2021 semester [Ex. 118 at 3, 5; see also Exs. 102104].
The choice of foregoing vaccination is not inconsequential. If not vaccinated,
students are not permitted on campus, their emails and university accounts are
suspended, and their access cards are deactivated [Ex. 118 at 7]. Although it seems from
argument that the university will not create an informant culture, it reserves the right to
pursue disciplinary action should a student deceive the process. Faculty and staff who
refuse vaccination face termination. The faculty councils from Indiana University—
Bloomington and Indiana University-Purdue University Indianapolis and the staff
council from Indiana University—Bloomington, have endorsed the policy, as has the
graduate and professional student government [Ex. 116 ¶ 45-60].
The university’s COVID-19 vaccine policy has exemptions. A student may request
an exemption for religious reasons; provide proof from a physician of an allergy to the
vaccine or one of its component parts (a medical exemption); provide proof from a
physician of active pregnancy or breastfeeding, receiving a hematopoietic or solid organ
transplant, receiving treatment with Rituximab within the past 3-6 months, or COVIDspecific monoclonal antibodies19 in the past 90 days (a medical deferral) [Ex. 210 at 3].
Students who are enrolled in an online program, with no on-campus component, don’t
need to receive the vaccine [id.].
Monoclonal antibody therapy involves the injection of laboratory-made proteins that mimic the immune
system’s ability to fight off various pathogens. FDA, Coronavirus (COVID-19) Update: FDA Revokes
Emergency Use Authorization for Monoclonal Antibody Bamlanivimab (April 16, 2021),
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For those who receive exemption from vaccination, the policy imposes additional
safety requirements. These requirements apply to six of the eight students here who have
received exemptions and potentially a seventh who qualifies for an exemption. Such
students must participate in more frequent mitigation testing, quarantine if exposed to
someone who has tested positive for COVID-19, wear a mask in public spaces, and return
to their permanent address or quarantine if there is a serious outbreak of COVID-19 [Ex.
118 at 6].
The parties have tendered declarations, supplemental declarations, and testimony
from several experts, leaving to the court the task of deciding what weight to give to their
opinions. Among the more than 100 exhibits admitted for this preliminary injunction
motion, the experts and other materials refer to numerous medical studies and industry
guidance on the risks of COVID-19 and the risks of the vaccines—where the parties in
part have drawn the battle lines. The court has endeavored to be studious in reviewing
at times a daunting record on this emergent timetable.
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The university offers Dr. Cole Beeler, MD,20 and Dr. Aaron Carroll, MD, MS,21 and
the students tender Dr. Peter McCullough, MD, MPH.22 All have credentials and opinions
that exceed restatement here. Much of that treatment occurs later in this opinion as the
court makes additional findings of fact and discusses its legal analysis. Though points of
agreement occur at times, these experts largely disagree about the urgency of vaccination,
particularly for often younger university students, the effects from natural COVID-19
infection, and the risks of the three emergency use approved vaccinations.
For the students, Dr. McCullough says the risks of COVID-19 to college age
students in 2021 proves significantly lower than in 2020 because of the rapidly declining
infection rate, increasing likelihood of herd immunity in Indiana, low risk of serious
complications or death from COVID-19 in college-aged students, low risk of
asymptomatic spread, and other posited COVID-19 treatments [Ex. 117 ¶ 73; see also Exs.
221-22, 233-34, 240-41, 246-47, 251]. He views a mandate as unwise and a violation of the
medical ethics principle of autonomy translated to the university setting [Ex. 117 ¶ 73].
He opines that the risks associated with the COVID-19 vaccines “are not minor or
Dr. Beeler is an assistant professor of clinical medicine at Indiana University Medical School. He earned
his BS and MD from Indiana University and is board certified in infectious disease and internal medicine
[Ex. 115 ¶ 1-5; Ex. 128 at 5, 7-11, 13-17, 21-22, 31, 147-150].
Dr. Carroll is the chief health officer for Indiana University and associate dean for research mentoring at
Indiana University Medical School who holds various professorial positions. He earned his BA from
Amherst College, his MD from the University of Pennsylvania, and his MS from the University of
Washington. He is board certified in preventative medicine-clinical informatics, pediatrics, and by the
National Board of Medical Examiners [Ex. 116 ¶ 1-6; Ex. 206 at 7-8].
Dr. McCullough is a professor of medicine at Texas A & M University School of Medicine and practices
medicine at various Texas hospitals. He received his BA from Baylor University, MD from University of
Texas Southwestern Medical School, and his MPH in epidemiology from the University of Michigan. He is
board certified in internal medicine and cardiovascular disease [Ex. 117 ¶ 1-12].
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unserious and can include hospitalization and death,” however “unpredictable” and
“impossible to calculate” [id.]. His opening declaration largely isn’t stated to any
reasonable degree of medical certainty [id.; but cf. Ex. 222 at 11].
For the university, Dr. Beeler says the COVID-19 vaccine mandate facilitates a
“safe and reliable way to assure lack of spread of COVID” within the university’s campus
communities and “prevents morbidity and mortality” [Ex. 115 ¶ 87; see also Ex. 319]. He
appreciates that, though COVID-19 often will not pose “disproportionate bad outcomes”
in the university’s constituency, “any bad outcome from COVID is potentially avoidable
with the vaccines where the benefit dwarfs the potential rare risks,” and risks that “may
not be causally linked” [Ex. 115 ¶ 87]. He recalls that “the vaccines used for COVID are
based on technology that has been developed over decades and have repeatedly been
shown to be safe when given to millions of patients” [id.]. He calls the vaccines “known
science” applied to a “novel pathogen” with often “uncertain and threatening immediate
and long-term consequences to [the university’s] students, faculty, staff, and
communities at large” [id.]. He says the risk of asymptomatic hosts puts others at risk
[id.]. In support, Dr. Carroll marshals relevant industry, governmental, and university
guidance and the relevant scrutiny the restart committee gave to it [Exs. 116, 301]. Dr.
Beeler states his opinions to a reasonable degree of medical or professional certainty [Ex.
115 at 25; Ex. 319 at 8].
Emergency Use Authorization of Vaccines.
COVID-19 caught the world unaware. Initially, there were no vaccines or
treatments, and testing was expensive and difficult to secure. Four days after the United
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States Department of Health and Human Services (HHS) declared a public health
emergency, it issued a second declaration allowing the United States Food and Drug
Administration (FDA) to grant emergency use authorizations (EUAs) for medical devices
and interventions to combat the pandemic. 85 Fed. Reg. 7316, 7316-7317; 85 Fed. Reg.
Despite creating an expedited pathway to distribute new medical products during
emergencies, products that receive EUA approval still must adhere to specified safety,
efficacy, and manufacturing criteria, and HHS must ensure medical providers and
individuals are informed of the product’s EUA status, the “significant known and
potential benefits and risks of such use, and of the extent to which such benefits and risks
are unknown;” and for individuals, of the option to refuse and the consequences of such
a decision. 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(I)-(III). An EUA generally allows a
manufacturer to apply for EUA approval using interim clinical trial data, and the data
need only demonstrate the product “may be effective” and that the known and potential
benefits outweigh the known and potential risks.23 The statute anticipates the FDA will
impose additional obligations beyond those enumerated. 21 U.S.C. § 360bbb-3(e)(1)(B).
There have been six significant public health emergencies for which the FDA has
authorized EUAs: anthrax, swine flu (H1N1), MERS (Middle East respiratory syndrome
21 U.S.C. § 360bbb-3(c)(2)(A); FDA, Emergency Use Authorization for Vaccines Explained,
https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccinesexplained (last visited July 13, 2021).
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coronavirus), Ebola, Zika, and now COVID-19.24 During these events, EUAs were issued
for diagnostic tests (swine flu, MERS, Ebola, Zika, and COVID-19), off-label use of
previously approved and use of unapproved pharmaceuticals (anthrax, swine flu, and
COVID-19), novel vaccines (anthrax and COVID-19), and medical devices (swine flu and
COVID-19).24 FDA authorization for EUA vaccinations began in 2005 during the anthrax
scare, particularly for use in the armed forces. See 70 Fed. Reg. 5452, 5453 (Feb. 2, 2005).25
Later in 2009, based on a CDC request, the FDA issued the first EUA that was geared
towards civilians, including infants, for Tamiflu, an antiviral otherwise approved for use
in adults. 74 Fed. Reg. 56644 (Nov. 2, 2009).26
Not all EUAs are created equally. Because of the widespread use of a COVID-19
vaccine, the FDA informed manufacturers that it expected the same level of endpoint
efficacy data as required for full approval, enough safety data to justify by clear and
compelling evidence the vaccine’s safety, and confirmation of the technical procedures
and verification steps necessary to support full approval.27 In short, and as described in
more detail below in this opinion’s analysis, the FDA promulgated guidance that
FDA, Emergency Use Authorization—Archived Information, https://www.fda.gov/emergencypreparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorizationarchived-information#H1N1 (last visited July 16, 2021).
See also Stuart L. Nightingale et al., Emergency Use Authorization (EUA) to Enable Use of Needed Products in
Civilian and Military Emergencies, United States, 13(7) Emerging Infectious Diseases 1047 (July 2007),
CDC, Updated Interim Recommendations for the Use of Antiviral Medications in the Treatment and Prevention
FDA, Emergency Use Authorization for Vaccines to Prevent COVID-19: Guidance for Industry (May 2021),
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enhanced the basis on which any COVID-19 vaccine would meet EUA approval. In
setting these more stringent standards, the FDA invited EUA applications only for
vaccines positioned well to receive full approval.28
In the United States, three vaccines rushed to the front: two using mRNA
technology and one using a viral vector [Ex. 115 ¶ 23-26]. Johnson & Johnson’s vaccine is
a viral vector vaccine (implementing technology since the 1970s) that uses a modified
version of a virus to teach the immune system to respond [Ex. 115 ¶ 87].29 Pfizer and
Moderna’s vaccines use mRNA, a novel type of vaccine, but one based on decades of
research using easily accessible materials found already in many laboratories [id.].30
The industry guidance has since been superseded twice, once in February 2021 and once in May 2021.
FDA, Emergency Use Authorization for Vaccines to Prevent COVID-19: Guidance for Industry (May 2021). Pfizer,
Moderna, and Johnson & Johnson’s applications were submitted in accordance with the October 2020
enhanced guidance, see FDA, Emergency Use Authorization (EUA) for an Unapproved Product Review
Memorandum (Pfizer-BioNTech) (2020) https://www.fda.gov/media/144416/download; (application
submitted November 20, 2020); FDA, Emergency Use Authorization (EUA) for an Unapproved Product Review
Memorandum (Moderna) (2020) https://www.fda.gov/media/144673/download (application submitted
November 30, 2020); FDA, Emergency Use Authorization (EUA) for an Unapproved Product Review
Memorandum (Janssen) (2021) https://www.fda.gov/media/146338/download (application submitted
February 4, 2021).
See CDC, Understanding Viral Vector COVID-19 Vaccines, https://www.cdc.gov/coronavirus/2019ncov/vaccines/different-vaccines/viralvector.html (last visited July 16, 2021).
See CDC, Understanding mRNA COVID-19 Vaccines, https://www.cdc.gov/coronavirus/2019ncov/vaccines/different-vaccines/mrna.html (last visited July 16, 2021).
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Having quickly adapted the existing technology, Moderna started testing the vaccine in
humans in March 2020.31 Pfizer began clinical trials in late April 2020.32
By the time Pfizer applied for an EUA on November 20, 2020, their application
included safety, immunogenicity, and efficacy data from over 40,000 study participants
in ongoing phase I, II, and III, randomized, placebo-controlled, observer-blind, clinical
trials conducted in the U.S., Argentina, Brazil, Germany, South Africa, and Turkey.33 A
team of representatives from across the FDA, including experts in clinical review,
toxicology, biostatistics, products, production facilities, pharmacovigilance, data
integrity, bioresearch monitoring, and labeling reviewed the data submitted by Pfizer,
and independently assessed the risks and benefits of the vaccine.34 The agency granted
the EUA on December 11, 2020, noting that Pfizer “met the FDA’s expectations as
conveyed in [the agency’s] June and October guidance documents.”35
Nat’l Insts. Health (NIH), Experimental Coronavirus Vaccine is Safe and Produces Immune Response (Moderna),
NIH, Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates against
COVID-19 in Healthy Individuals, https://clinicaltrials.gov/ct2/show/NCT04368728 (last visited July 16,
FDA, Pfizer-BioNTech COVID-19 Vaccine Emergency Use Authorization Review Memorandum,
Id. at 1, 49-54.
FDA, FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First
COVID-19 Vaccine (Dec. 11, 2020) https://www.fda.gov/news-events/press-announcements/fda-takeskey-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19.
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Moderna applied for an EUA on November 30, 2020.36 Their application included
safety, immunogenicity, and efficacy data from over 30,000 study participants in ongoing
phase I, II, and III, randomized, stratified, observer-blind, placebo-controlled clinical
trials conducted at 99 locations in the United States.37 A team of representatives from
across the FDA, including experts in clinical review, toxicology, biostatistics, products,
production facilities, pharmacovigilance, data integrity, bioresearch monitoring, and
labeling, reviewed the data submitted by Moderna, and independently assessed the risks
and benefits of the vaccine.38 The agency granted the EUA on December 18, 2020, noting
that “the FDA’s expectations described in [the agency’s] June and October guidance
documents have been met.”39
Janssen, a Johnson & Johnson company, applied for an EUA on February 4, 2021.40
Their application included safety, immunogenicity, and efficacy data from five studies,
including two randomized, double-blind, placebo-controlled phase III trials, enrolling
over 70,000 participants.41 A team of representatives from across the FDA, including
experts in clinical review, toxicology, biostatistics, products, production facilities,
FDA, Emergency Use Authorization (EUA) for an Unapproved Product Review Memorandum (Moderna),
Id. at 12-13.
Id. at 1, 55-60.
FDA, FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for
Second COVID-19 Vaccine (Dec. 18, 2020) https://www.fda.gov/news-events/press-announcements/fdatakes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid.
FDA, Emergency Use Authorization (EUA) for an Unapproved Product Review Memorandum (Janssen),
Id. at 13.
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pharmacovigilance, data integrity, bioresearch monitoring, and labeling, reviewed the
data submitted by Johnson & Johnson, and independently assessed the risks and benefits
of the vaccine.42 The FDA granted the EUA on February 27, 2021, noting that “the vaccine
meets the FDA’s expectations for safety and effectiveness appropriate for authorization
of a vaccine for emergency use.”43
With these vaccines, an emerging light appeared at the end of the tunnel. As of
July 17, 2021, 337,239,448 doses of vaccine have been administered, and 161 million
Americans, or 48.5 percent of the total population, is fully vaccinated.44 Of adults over
the age of eighteen, 59.4 percent are fully vaccinated.44 In Indiana, 5,749,173 doses have
been administered, and 2,888,239 Hoosiers, or 49.6 percent of those over the age of twelve,
are fully vaccinated.45 Of ages 18-24, who account for 9.2 percent of the U.S. population,
11,720,847, or 42.2 percent, are fully vaccinated.46 In Indiana, 164,098 individuals aged 2024, or 34.7 percent, are fully vaccinated.47
Id. at 1, 59-61.
FDA, FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine (February 27, 2021)
CDC, COVID-19 Vaccinations in the
tracker/#vaccinations (last visited July 17, 2021).
ISDH, Indiana COVID-19 Vaccination Dashboard, https://www.coronavirus.in.gov/vaccine/2680.htm
(last visited July 18, 2021).
CDC, COVID-19 Vaccinations in the
tracker/#vaccinations (last visited July 17, 2021).
ISDH, Indiana COVID-19 Vaccination Dashboard, https://www.coronavirus.in.gov/vaccine/2680.htm
(last visited July 18, 2021).
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Risks of Vaccines.
Though the vaccines show remarkable effectiveness against infection and severe
cases of COVID-19, and “have undergone and will continue to undergo the most
intensive safety monitoring in U.S. history,” they are not without risks, heretofore rare
for serious risks [Ex. 115 ¶ 33].48 Many recipients experience mild local and systemic
reactions, including fever, headache, muscle pain, chills, and tiredness.48 In very rare
cases, more serious side effects seem to emerge such as allergic reactions or blood clots
with low platelets [Ex. 115 ¶ 66; Ex. 117 ¶ 38].48 For young men specifically, experts are
studying a temporal correlation between vaccines and myocarditis, an inflammation of
the heart muscle, or pericarditis, inflammation of tissue around the heart [Ex 117 ¶ 37].49
However, the risk of myocarditis appears to be exceptionally small [Ex. 115 ¶ 67].50
The medical community closely tracks adverse events from the vaccine in a
national database called VAERS, or the Vaccine Adverse Event Reporting System.51 This
database is used to track adverse events temporally related to all vaccine administration,
including for the COVID-19 vaccines, but it is not a definitive or final resource to
https://www.cdc.gov/coronavirus/2019ncov/vaccines/safety/safety-of-vaccines.html (last visited July 13, 2021).
See also Han W. Kim et al., Patients with Acute Myocarditis Following mRNA COVID-19 Vaccination, JAMA
Cardiol doi:10.1001/jamacardio.2021.2828 (June 29, 2021)
https://jamanetwork.com/journals/jamacardiology/fullarticle/2781602 (finding handful of patients out
of 561,197, and all recovered after a few days).
See, e.g., Israeli Ministry of Health, Surveillance of Myocarditis (Inflammation of the Heart Muscle) Cases
Between December 2020 and May 2021, https://www.gov.il/en/departments/news/01062021-03 (last
visited July 18, 2021) (121 cases out of a total of 5,049,424 vaccinated individuals).
HHS, VAERS, https://vaers.hhs.gov/.
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conclusively prove contraindications.52 “While very important in monitoring vaccine
safety, VAERS reports alone cannot be used to determine if a vaccine caused or
contributed to an adverse event or illness.”53 Nevertheless, the FDA considers VAERS
data when assessing whether to make changes to any approval or to apply any additional
warnings to vaccines.54 Based on this surveillance, reports of anaphylaxis appears to be
rare, blood clotting concerns are rare but higher in women under the age of 50,
myocarditis is rare but more common in young people, and reports of death are rare.55
The FDA has issued revisions to the patient and provider fact sheets about the risk
of myocarditis and pericarditis acknowledging data about this risk.56 Furthermore, the
FDA and CDC recommended a pause on the use of Johnson & Johnson’s vaccine in light
of reports of clotting in young women (a pause subsequently lifted).57 Recent changes last
week occurred because of reported neurological impacts of the Johnson & Johnson
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html (last visited July 13,
CDC, The Vaccine Adverse Event Reporting System (VAERS) Results (July 17, 2021),
See, e.g., FDA, Coronavirus (COVID-19) Update: July 13, 2021 (July 13, 2021) (discussing concerns over
Id.; see also CDC, The Vaccine Adverse Event Reporting System, https://wonder.cdc.gov/vaers.html (last
visited July 14, 2021); CDC, COVID-19 Vaccination Demographics in the United States, National,
(last visited July 18, 2021) (more than 24 million doses of a vaccine have been administered to this age group
as of July 14, 2021)
FDA, Coronavirus (COVID-19) Update: June 25, 2021, https://www.fda.gov/news-events/pressannouncements/coronavirus-covid-19-update-june-25-2021 (last visited July 13, 2021).
CDC, CDC Recommends Use of Johnson & Johnson’s Janssen COVID-19 Vaccine Resume,
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/JJUpdate.html (last visited July 13, 2021).
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vaccine, based on VAERS data.58 These refinements indicate that the ongoing safety of
these vaccines are rigorously monitored by agency professionals.
Much has been said of herd immunity at the national and state levels. The
university too wants to achieve herd immunity. Herd immunity occurs when a virus
cannot spread because so many of the individuals it encounters are protected against
infection [Ex. 117 ¶ 14-17; Ex. 115 ¶ 43-44].59 The students say we are there [Ex. 117 ¶ 1417]. The university disagrees [Ex. 116 ¶ 43]. As more infectious variants emerge, some
suggest the percent immunized must also increase to reach herd immunity [Ex. 115 ¶ 1922].60 Like many aspects of the pandemic, the point at which society is able to conclude
enough people have protection from the virus is still undetermined.
The character of immunity is also uncertain. As COVID-19 is a new disease, and
the vaccines are even newer, the long-term efficacy of immunity derived from vaccination
and infection is not proven [Ex. 117 ¶ 68-72; Ex. 115 ¶ 70].61 Immune responses appear to
exist for at least several months following a COVID-19 infection [Ex. 117 ¶ 68-72; Ex. 319
FDA, Coronavirus (COVID-19) Update: July 13, 2021 (July 13, 2021) (discussing concerns over VAERS
reports of Guillain-Barre syndrome following vaccination) (available at https://www.fda.gov/newsevents/press-announcements/coronavirus-covid-19-update-july-13-2021).
Christie Aschwanden, The False Promise of Herd Immunity for COVID-19,
https://www.nature.com/articles/d41586-020-02948-4 (Last visited July 13, 2021).
60 See Kamran Kadknoda, Herd Immunity to COVID-19, Am. J. Clin Gypsyamber D’Souza & David Dowdy,
What is Herd Immunity and How Can We Achieve It With COVID-19?, https://www.jhsph.edu/covid19/articles/achieving-herd-immunity-with-covid19.html (last visited July 13, 2021).
See Jennifer M. Dan, Immunological Memory to SARS-CoV-2 Assessed for Up to 8 Months after Infection,
371(6529) Science eab4063 (Feb. 5, 2021); See Chris Baraniuk, How Long Does Covid-19 Immunity Last?, 373
BMJ n1605 (June 30, 2021) https://www.bmj.com/content/373/bmj.n1605.short?rss=1.
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¶ 1].61 Dr. Beeler explains a recent study that suggests that vaccination after COVID-19
exposure secures more protection than just antibodies from prior contraction of the
virus—in terms of duration and strength against the prevailing variants [Ex. 128 at 82].62
The parties disagree over the relative risk of college students spreading the virus
to the community, with the students contending the risk is very low [see Ex. 117 ¶ 29-31],
and the university contending the risk is real [see Ex. 115 ¶ 51-52]. There is no consensus
on this issue, and some research has not been peer-reviewed.63 Nevertheless, peerreviewed research suggests that outbreaks on college campuses pose a risk of spreading
to neighboring communities.64 Data suggest that as of May 26, 2021, 260,000 infections
have been linked to universities and colleges in 2021, including 3,062 reported cases
across the Indiana University system—though this data appears limited to students,
faculty members, staff members, and other college workers, and thus does not provide
insight on greater community spread [see Ex. 115 ¶ 52].65 Universities are unique
See Delphine Planas et al., Reduced Sensitivity of SARS-CoV-2 Variant Delta to Antibody Neutralization,
Nature doi: 10.1038/s41586-021-03777-9, 3 (July 8, 2021) (online ahead of print),
63 See Callum R.K. Arnold et al., SARS-CoV-2 Seroprevalence in a University Community: A Longitudinal Study
of the Impact of Student Return to Campus on Infection Risk Among Community Members, medRxiv Preprint (Feb
19, 2021) https://pubmed.ncbi.nlm.nih.gov/33619497/ (minimum impact on community); but see Gabriel
T. Bosslet et al., The Effect of In-Person Primary and Secondary School Instruction on County-Level SARS-CoV-2
Spread in Indiana, Clinical Infectious Diseases (manuscript accepted) https://doi.org/10.1093/cid/ciab306
(Apr. 13, 2021) (finding that a 10 percent increase in K-12 students attending school in-person corresponded
to a daily increase of 0.336 cases per 100,000 residents in the community).
See Hannah Lu et al., Are College Campuses Superspreaders? A Data-Driven Modeling Study, Computer
Methods in Biomechanics & Biomedical Eng’g, https://doi.org/10.1080/10255842.2020.1869221 (Jan. 13,
2021) (Stanford researchers looked at county spikes following outbreaks at 30 universities and concluded
that outbreaks at 17 campuses translated directly into respective community spikes).
N.Y. Times, Tracking Coronavirus Cases at U.S. Colleges and Universities (May 26, 2021),
https://www.nytimes.com/interactive/2021/us/college-covid-tracker.html (last visited July 13, 2021).
The New York Times appears to be the most comprehensive database for tracking COVID-19 cases across
U.S. colleges and universities, collecting and compiling data from individual universities, local health
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environments, with students, faculty, and staff often in close contact, particularly given
the number that call Indiana University home.
The Student’s Objections.
The eight plaintiffs in this case, all students of Indiana University, don’t want the
vaccine. Six of the eight have received exemptions already. One would qualify if she
applied. The other appears not to qualify for an exemption.
Ryan Klaassen is concerned that the vaccine is too new to be safe [Ex. 120 at 18].
He objects to the masking and testing requirements because of their unreasonableness
and the potential for discrimination [id. 36]. He complied with the university’s mask
policy during his freshman year, including wearing a mask in most places, and has
undergone many COVID-19 tests [id. 27].
Jaime Carini has up to seven more years to finish her joint dissertation after she
finishes her exams [Ex. 121 at 23]. Her physician provided a letter saying she should not
take the vaccine, though the letter has not been presented to the university or to the court
[Ex. 121 at 52-53]. She applied for a religious exemption and received one [id. 57]. She did
not apply for a medical exemption [Ex. 100 ¶ 187 (never applied for one); Ex. 121 at 60].
Despite wearing a mask in public spaces when required and previously taking several
COVID-19 tests, she objects to the mask policy because it makes it difficult for her to
breathe, she gets bad acne from the mask, and she struggles deadlifting with a mask [Ex.
departments, counties, states, and through open record requests at universities who would not otherwise
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121 at 44, 47-51]. She also doesn’t like surrendering her biological information for testing
[id. 55]. In total, she views the university’s policy as a cultural harm [id. 55-56].
Daniel Baumgartner says he has a deeply held religious objection to wearing a
mask and being tested. He wore a mask while attending religious services, in school, and
at stores in the past [Ex. 122 at 8, 18-20]. He previously contracted COVID-19 and says he
has “natural” COVID antibodies, though for how long he doesn’t know [id. 21-22].
Ashlee Morris believes she previously contracted COVID-19 [Ex. 123 at 27-28]. She
has been tested before and acknowledges that she did not suffer any lasting harm from
the test [id. 35]. She wore a mask to work, on a plane, and when she went to a casino, but
not to stores even if signs were posted [id. 35-37]. She testifies she has a religious objection
to wearing a mask and being tested [id. 45-48]. She admits that she has never experienced
discrimination because she did not wear a mask [id. 56].
Seth Crowder has a deeply held religious objection to wearing a mask and being
tested [Ex. 124 at 29-30]. He has worn a mask once or twice a week since March 2020,
including to stores and restaurants [id. 22].
Macey Policka objects generally to the extra requirements of masks and tests
because of the minimal risk to those in her age group, also stating that vegans and
pescatarians are less likely to experience serious illness [Ex. 125 at 28]. She lived on the
Bloomington campus for the 2020 school year, complied with the university’s masking
policy, and underwent weekly mitigation testing from which she states she did not suffer
any harm [id. 14-18]. She has never experienced judgment or alienation due to wearing a
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mask at the university but is concerned about having to wear a mask while pursuing her
theatre degree [id. 25, 42].
Margaret Roth objects to the mask and testing requirements because she thinks
masks are silly and she claims nasal swabs cause cancer [Ex. 126 at 12, 29, 35-36]. She has
worn a mask while at school, shopping, and working [id. 31-33]. She has a religious
objection to the vaccine but did not file for an exemption because she doesn’t want to be
subject to testing or wear a mask [id. 45-47].
Natalie Sperazza complied with the university testing and masking requirement
during the 2020 school year [Ex. 127 at 30-32]. She has been tested for COVID-19 many
times, including while working at Amazon, where she would occasionally go to get tested
just to have a break [id. 25-26, 30].
The students filed a preliminary injunction motion. The court expedited briefing
and discovery. The court held oral argument on July 13, 2021, after receiving the record
the day before. The parties stipulated to the admissibility of all exhibits. The parties
stipulated not to present additional testimony at the preliminary injunction hearing
because it would duplicate what they had presented already.
Further evidentiary hearing is generally required for a preliminary injunction
motion when there are “genuine issues of material fact” and either side “intends to
introduce evidence [at the hearing] that if believed will so weaken [the other’s] case as to
affect the judge’s decision on whether to issue the injunction.” Ty, Inc. v. GMA Accessories,
Inc., 132 F.3d 1167, 1171 (7th Cir. 1997). That said, such a hearing isn’t necessary when the
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evidence would essentially duplicate the declarations, depositions, and other documents
the parties have already submitted. See Goodman v. Ill. Dep’t of Fin. & Pro. Regul., 430 F.3d
432, 439 (7th Cir. 2005) (summarizing Ty, Inc., 132 F.3d at 1171); Ty, Inc., 132 F.3d at 1171.
No additional hearing was necessary here. The court has considered over a hundred
written exhibits, including sworn depositions and declarations, and heard three hours of
argument. This motion is ripe for immediate ruling.
Before considering the preliminary injunction motion, the court must ensure its
jurisdiction. See Common Cause Ind. v. Lawson, 937 F.3d 944, 949 (7th Cir. 2019); Simic v.
City of Chicago, 851 F.3d 734, 738 (7th Cir. 2017). The United States Constitution confines
the federal judiciary’s power to “Cases” and “Controversies.” U.S. Const. Art. III § 2. For
a case or controversy to exist, a plaintiff must have standing—an injury, fairly traceable
to the defendant’s conduct, that the court’s decision will likely redress. Uzuegbunam v.
Preczewski, 141 S. Ct. 792, 797 (2021); Spokeo, Inc. v. Robins, 136 S. Ct. 1540, 1547 (2016).
Indiana University raises the issue of standing. Of the eight students here, six have
received an exemption under the university’s policy and one (Margaret Roth) qualifies
so long as she pursues it. This leaves one student (Natalie Sperazza) who yet faces an
unexemptible choice this semester: either she gets vaccinated or she cannot attend
Indiana University this fall. She doesn’t qualify for an exemption. At minimum, she has
standing—an injury fairly traced to Indiana University’s decision to mandate the vaccine
and one the court can redress. See Uzuegbunam, 141 S. Ct. at 797; Taylor v. McCament, 875
F.3d 849, 853 (7th Cir. 2017).
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The court has subject matter jurisdiction under Article III so long as one plaintiff
has standing. See Horne v. Flores, 557 U.S. 433, 446 (2009); Massachusetts v. E.P.A., 549 U.S.
497, 518 (2007). Even when the standing of others may prove doubtful, see, e.g., Chi. Joe’s
Tea Room, LLC v. Vill. of Broadview, 894 F.3d 807, 813 (7th Cir. 2018), the court’s jurisdiction
remains intact so long as one plaintiff has demonstrated standing to assert her rights,
Horne, 557 U.S. at 446. The court thus may proceed to this preliminary injunction motion
without addressing the standing of the other students. See id.
That said, the court remains mindful (and the reader should too) that it cannot
issue a mere advisory opinion. Article III’s “case or controversy” requirement prohibits
“advisory opinions that do not affect the rights of the parties before the court.” Matlin v.
Spin Master Corp., 979 F.3d 1177, 1181 (7th Cir. 2020) (citation omitted). The court isn’t a
law office established for legal advice—the federal judiciary decides cases, not
hypothetical outcomes. If the court’s decision doesn’t affect a litigant’s rights, “the
aggrieved party [is] unable to illustrate the redressability component of standing,
rendering any judicial decision in the case an impermissible advisory opinion.” United
States v. Brixen, 908 F.3d 276, 280 (7th Cir. 2018). In short, the court won’t decide today
issues that would not redress the injuries these particular students allege.
PRELIMINARY INJUNCTION STANDARD
A preliminary injunction is a “very far-reaching power, never to be indulged 
except in a case clearly demanding it.” Cassell v. Snyders, 990 F.3d 539, 544 (7th Cir. 2021)
(quoting Orr v. Shicker, 953 F.3d 490, 501 (7th Cir. 2020)). To obtain an injunction, the
students “must make a threshold showing that: (1) absent preliminary injunctive relief,
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[they] will suffer irreparable harm in the interim prior to a final resolution; (2) there is no
adequate remedy at law; and (3) [they have] a reasonable likelihood of success on the
merits.” Tully v. Okeson, 977 F.3d 608, 612-13 (7th Cir. 2020) (quoting Turnell v. CentiMark
Corp., 796 F.3d 656, 662 (7th Cir. 2015)); see also Winter v. Nat. Resources Defense Council,
Inc., 555 U.S. 7, 20 (2008). If they make these threshold showings, the court “consider[s]
the balance of harms between the parties and the effect of granting or denying a
preliminary injunction on the public interest.” Tully, 977 F.3d at 613 (quotation omitted).
These Students Aren’t Likely to Succeed on the Merits.
No case to date has decided the constitutionality of whether a public university,
such as Indiana University, may mandate that its students receive a COVID-19 vaccine.66
Given the unique constitutional nature of this case, the court assesses the students’
likelihood of success first, ever mindful that this determination proves preliminary only.
The students must show a likelihood of success on the merits. This is their burden.
This showing must be “strong,” which “normally includes a demonstration of how the
applicant proposes to prove the key elements of [the] case.” Tully, 977 F.3d at 613 (quoting
Ill. Republican Party v. Pritzker, 973 F.3d 760, 762-63 (7th Cir. 2020)). Though an “applicant
need not show that [she] definitely will win the case,” a “mere possibility of success is
not enough.” Pritzker, 973 F.3d at 762-63.
A district court recently upheld a COVID-19 vaccine mandate, albeit by a private employer (hospital).
See Bridges v. Houston Methodist Hosp., 2021 U.S. Dist. LEXIS 110382, 7-8 (S.D. Tex. June 12, 2021).
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The Fourteenth Amendment.
The students pursue a Fourteenth Amendment claim. The Bill of Rights—the first
ten amendments to the United States Constitution—originally applied only to the federal
government. See McDonald v. City of Chicago, 561 U.S. 742, 754 (2010). Individual states
weren’t obligated to respect its protections against citizens. See Livingston’s Lessee v.
Moore, 32 U.S. 469, 551-52 (1833); see also McDonald, 561 U.S. at 754 (citing Moore, 32 U.S.
at 551-52). This changed with the Fourteenth Amendment in 1868.
The Fourteenth Amendment “furnishe[d] an additional guaranty against any
encroachment by the States upon the fundamental rights [that] belong to every citizen as
a member of society.” United States v. Cruikshank, 92 U.S. 542, 554 (1875); accord United
States v. Morrison, 529 U.S. 598, 622 (2000); see also 42 U.S.C. § 1983; Albright v. Oliver, 510
U.S. 266, 271 (1994); Power v. Summers, 226 F.3d 815, 819 (7th Cir. 2000). For today’s
dispute, the Fourteenth Amendment says no “State [may] deprive any person of life,
liberty, or property, without due process of law.” U.S. Const. amend. XIV § 1. This due
process clause applies to the States and protects, absent a deprivation with due process,
certain rights to life, liberty, and property. Indiana University is a state actor, Medlock v.
Trustees of Ind. Univ., 738 F.3d 867, 871 (7th Cir. 2013), so the Fourteenth Amendment also
applies to it.
As interpreted, the Fourteenth Amendment has both substantive and procedural
dimensions. See Cleveland Bd. of Educ. v. Loudermill, 470 U.S. 532, 541 (1985). This case
concerns substantive due process—“a substantive limitation on the power of government
to legislate.” Durigan v. Sanitary Dist. No. 4, 5 F. Appx. 492, 494 (7th Cir. 2001); see Campos
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v. Cook Cnty., 932 F.3d 972, 975 (7th Cir. 2019). The Fourteenth Amendment protects a
person’s substantive rights in life, liberty, and property. U.S. Const. amend. XIV § 1.
Certain rights or liberties have been deemed “fundamental,” so they receive greater
protection. See Washington v. Glucksberg, 521 U.S. 702, 720-21 (1997).
Bearing that in mind, the court initially approaches this case in a two-fold manner.
First, the law requires a “careful description” of the asserted right or liberty. See id. at 721;
see, e.g., Doe v. City of Lafayette, 377 F.3d 757, 768 (7th Cir. 2004). Second, the court must
determine whether the so-defined right or liberty is fundamental under the Constitution.
See Glucksberg, 521 U.S. at 721; Doe, 377 F.3d at 768. The Fourteenth Amendment’s due
process clause specially protects fundamental rights and liberties—those that objectively
are “deeply rooted in this Nation’s history and tradition” and so “implicit in the concept
of ordered liberty” that “neither liberty nor justice would exist if they were sacrificed.”
Glucksberg, 521 U.S. at 721 (citations omitted); accord Khan v. Bland, 630 F.3d 519, 535 (7th
Cir. 2010). These guideposts direct and restrain due process decisionmaking. Glucksberg,
521 U.S. at 721.
Many rights explicitly secured in the Bill of Rights are considered fundamental,
having been gradually incorporated as substantive guarantees under the Fourteenth
Amendment. These fundamental rights include, as examples, freedom of speech, Gitlow
v. New York, 268 U.S. 652 (1925); freedom of the press, Near v. Minnesota, 283 U.S. 697
(1931); the right against cruel and unusual punishment, Robinson v. California, 370 U.S.
660 (1962); and the right to keep and bear arms, McDonald, 561 U.S. at 742. There are
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Fundamental rights aren’t limited to those specifically enumerated in the Bill of
Rights. Beginning with Griswold v. Connecticut, 381 U.S. 479, 483 (1965), the Supreme
Court recognized a right to privacy within the “penumbra” of other constitutional
protections and called it fundamental. This right to privacy has included the right for
both married and unmarried couples to purchase contraceptives, see Griswold, 381 U.S. at
484-86; Eisenstadt v. Baird, 405 U.S. 438, 454-55 (1972), to abortion, see Roe v. Wade, 410 U.S.
113, 153 (1973), to sexual privacy, Lawrence v. Texas, 539 U.S. 558, 578 (2003), and to marital
privacy, Obergefell v. Hodges, 576 U.S. 644, 664-65 (2015). As these cases illustrate, privacy
rights largely have been confined to “to sexual and reproductive rights, such as the right
to use contraceptives or have an abortion or engage in homosexual acts.” Wolfe v. Schaefer,
619 F.3d 782, 784 (7th Cir. 2010).
The students and university disagree on the constitutional analysis. Declaring a
right or liberty fundamental has important implications. Modern constitutional
jurisprudence employs a different analysis when a person’s fundamental right is at stake.
If the government infringes on a fundamental right, the court often applies strict scrutiny.
Glucksberg, 521 U.S. at 721. In such circumstances, the Fourteenth Amendment “forbids
the government to infringe . . . fundamental liberty interests at all, no matter what process
is provided, unless the infringement is narrowly tailored to serve a compelling state
interest.” Id. (quoting Reno v. Flores, 507 U.S. 292, 302 (1993)); see, e.g., Siefert v. Alexander,
608 F.3d 974, 981 (7th Cir. 2010); Ent. Software Ass’n v. Blagojevich, 469 F.3d 641, 646 (7th
Cir. 2006). This is the most rigorous form of constitutional scrutiny of government action.
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Whereas infringements on other rights or liberties, though still constitutionally
scrutinized, must meet what courts call rational basis review. Glucksberg, 521 U.S. at 722,
Sweeney v. Pence, 767 F.3d 654, 668 (7th Cir. 2014). The law normally applies this standard
to Fourteenth Amendment challenges to infringed liberties, if not fundamental or based
on a suspect classification. Roman Catholic Diocese of Brooklyn v. Cuomo, 141 S. Ct. 63, 70
(2020) (Gorsuch, J., concurring); see, e.g., Glucksberg, 521 U.S. at 721. It is less stringent than
strict scrutiny. Under rational basis review, “legislation is presumed to be valid and will
be sustained if the classification drawn by the statute is rationally related to a legitimate
state interest.” City of Cleburne v. Cleburne Living Ctr., 473 U.S. 432, 440 (1985). The
students argue for strict scrutiny, and the university argues for rational basis review.
The Constitution in a Public Health Crisis.
We live in the era of the COVID-19 virus—worldwide seeing to nearly 189 million
cases and 4 million deaths, with these numbers changing daily. The United States hasn’t
been immune. Our citizens have recovered or struggled to recover from over 33 million
cases of this novel coronavirus when over 606,000 tragically have passed.67 A public
health crisis of this magnitude begs the question: how should the law respond to state
action that infringes on the People’s liberties during such times?
To be sure, the Constitution isn’t put on the shelf. Indeed, in times of crisis,
perhaps constitutional adherence proves the very anchor we all need against irrational
and overweening government intrusion that would otherwise scuttle the ship. As the
CDC, Trends in Number of COVID-19 Cases and Deaths in the US Reported to CDC, by State/Territory (July
16, 2021), https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases.
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arbiters of the Constitution’s checks and balances, see Marbury v. Madison, 5 U.S. 137, 17678 (1803); accord Morrison, 529 U.S. at 616, the courts play an important role in ensuring
that the government doesn’t simply declare a never-ending public emergency and
expand its powers ad libitum to the People’s detriment.
Under our country’s federalist system, state and federal governments share
regulatory authority over public health matters. States traditionally exercise most
authority under their inherent police power—and reasonably so when public health may
flux and evolve by locale. States thus have the power, within constitutional limits, to pass
laws that “provide for the public health, safety, and morals[.]” Barnes v. Glen Theatre, 501
U.S. 560, 569 (1991); accord Glucksberg, 521 U.S. at 729-31; Zucht v. King, 260 U.S. 174, 17677 (1922), Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11, 24-25 (1905).
To answer the question today, the court travels back in time to 1905: a time before
the modern tiers of constitutional analysis (strict scrutiny and rational basis) and one
rampaged by the smallpox epidemic. In that year, the United States Supreme Court
issued a leading decision in answer to this question.
In Jacobson, 197 U.S. at 12, Massachusetts passed a law that allowed a city, if
“necessary for the public health or safety,” to enforce vaccination of its citizens. If a
person refused, he could be fined $5.00 (about $140.00 today). Id.; Cuomo, 141 S. Ct. at 70
(Gorsuch, J., concurring). The law allowed an exception for children who had physiciansigned certificates saying they weren’t fit for vaccination, but no such exemption existed
for adults. Jacobson, 197 U.S. at 12.
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The City of Cambridge, relying on this statute and acting through its board of
health, ordered its citizens vaccinated for smallpox. Id. at 12-13. Smallpox was
devastating, claiming almost 300 million lives in the 20th century before being
eradicated.68 In the early 1900s, and closer to the time that Massachusetts wrestled with
the disease, there were 1,596 cases of smallpox in Boston, with 270 deaths, in a city with
a population close to 561,000.69 Massachusetts, particularly Boston, was an epicenter of
one of two major smallpox outbreaks. Opponents of vaccination questioned its safety and
efficacy; though generally safe, it could cause ulceration, lobar pneumonia, cellulitis,
parotitis, sepsis, and tetanus, to name a few conditions.70 Side effects ostensibly posed a
greater problem than mild smallpox.71 The smallpox vaccine wasn’t risk-free in the early
1900s. That said, vaccinations had been used for some considerable time—begun by statesupported facilities in England in 1808 and mandated by many other countries
throughout the 1800s before the Massachusetts mandate in 1902. Id. at 31, n.1. This all
transpired before the FDA came into being.
Henning Jacobson refused the vaccine in Massachusetts. After a trial, a jury found
him guilty of refusing the vaccine. The court sentenced him to jail until he paid the $5.00
See D L Heymann et al., Successful Smallpox Eradication: What Can We Learn to Control COVID-19?, 27 J.
Travel Med. 1 (2020).
Michael R. Albert et al., The Last Smallpox Epidemic in Boston and the Vaccination Controversy, 1901-1903, 344
New Eng. J. Med. 375 (2001).
Id. at 375-76.
Bernard Brabin, An Analysis of the United States and United Kingdom Epidemics (1901-5)—The Special
Relationship that Tested Public Health Strategies for Disease Control, 64 Med. Hist. 1, 26 (2020).
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criminal fine. On appeal, he argued that the Massachusetts law authorizing the vaccine
mandate violated his Fourteenth Amendment rights. Id. at 13.
The United States Supreme Court rejected his challenge. A state’s police power
“must be held to embrace, at least, such reasonable regulations established directly by
legislative enactment as will protect the public health and the public safety.” Id. at 25.
This power included the “authority of a state to enact quarantine laws and health laws of
every description;” and such power extended to “all laws that relate to matters
completely within its territory and which do not by their necessary operation affect the
people of other states.” Id. The Constitution gave Massachusetts broad deference: a court
should only intervene “if a statute purporting to have been enacted to protect the public
health, the public morals, or the public safety, has no real or substantial relation to those
objects, or is beyond all question, a plain, palpable invasion of rights secured by the
fundamental law.” Id. at 31.
Of note, Jacobson upheld only the constitutionality of the state statute, id. at 39 (“We
now decide only that the statute covers the present case, and that nothing clearly appears
that would justify this court in holding it to be unconstitutional and inoperative in its
application to the plaintiff in error.”); and phrased its holding in terms of a reasonable
regulation established “directly by legislative enactment,” id. at 25, but the case
contemplated the action of local state bodies when vested legislatively with the power to
act to safeguard public health and safety, see, e.g., id. at 25, 38. A State’s power, “whether
exercised directly by the legislature, or by a local body acting under its authority, may be
exerted in such circumstances,” and only “regulations so arbitrary and oppressive in
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particular cases [would] justify the interference of the courts to prevent wrong and
oppression.” Id. at 38.
The students want Jacobson confined to its time, whereas the university believes it
applies with full force. In the years since, the high court has leaned on Jacobson to uphold
government measures intended for the public welfare under effectively rational basis
review, finding the measures reasonably advancing a legitimate state interest. For
example, Zucht, 260 U.S. at 175-77, relied on Jacobson to uphold a city ordinance excluding
from its public schools children not having a certificate of vaccination, holding that it was
within the state’s police powers reasonably to so act. According to Zucht, Jacobson settled
the state’s power “to provide for compulsory vaccination” and, “consistently with the
federal Constitution, delegate to a municipality authority to determine under what
conditions health regulations shall become operative.” Id. at 176. This was not
authorization of “arbitrary power,” but only that broad discretion required for the
protection of the public health.” Id. at 177. In doing so, “state and federal legislatures
[enjoy] wide discretion to pass legislation in areas where there is medical and scientific
uncertainty.” Gonzales v. Carhart, 550 U.S. 124, 163 (2007) (citing Jacobson, 197 U.S. at 3031).
Based on this power, states and their authorized arms have historically adopted
vaccination mandates. For instance, all fifty states and the District of Columbia have laws
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requiring students to receive certain vaccines before they may attend school.72 Many align
their vaccine requirements with CDC’s immunization recommendations, and all laws
provide exemptions for medical reasons and nearly all religious exemptions.72 Adult
vaccination mandates often have been limited to the private employment sector,73 though
not always. For instance, the State of Indiana requires all public university students to
meningococcal disease, save for religious and medical exemptions. See Ind. Code § 21-405-2.
Similarly, but outside the vaccination context, Hamilton v. Regents of the University
of California, 293 U.S. 245, 264 (1934), relied on Jacobson to uphold a state university’s
decision to compel military training for its students (five years before World War II).
Certain minors (not adults) were required to take a course in military science and tactics,
part of training prescribed by the country’s war department at the time. The students
objected on religious grounds through the Fourteenth Amendment—“no more than an
assertion that the due process clause of the Fourteenth Amendment as a safeguard of
‘liberty’ confers the right to be students in the State University free from obligation to
take military training as one of the conditions of attendance.” Id. at 262. Hamilton held
this view “untenable,” recognizing the government’s duty to the people to maintain
Nat’l Conf. of State Legislatures, States with Religious and Philosophical Exemptions from School Immunization
Requirements (April 30, 2021), https://www.ncsl.org/research/health/school-immunization-exemptionstate-laws.aspx.
Michael J. Vernick, Molly E. Whitman & McKenzie F. Miller, The Mandate Maze, Inside Higher Ed (May
25, 2021), https://www.insidehighered.com/views/2021/05/25/advice-legal-issues-related-vaccinemandates-opinion.
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peace and order and every citizen’s “reciprocal duty, according to his capacity, to support
and defend government against all enemies.” Id. at 262-63. Justice Cardozo eloquently
concurred: “The right of private judgment has never yet been so exalted above the powers
and the compulsion of the agencies of government. One who is a martyr to a principle—
which may turn out in the end to be a delusion or an error—does not prove by his
martyrdom that he has kept within the law.” Id. at 268.
Repose the thought whether we face just such a common enemy today in COVID19. In this century, other than the Supreme Court’s reliance on Jacobson in 2007, see
Gonzales, 550 U.S. at 163, courts have returned again to its guidance during the COVID19 pandemic. Just last year, this circuit endorsed Jacobson. See Pritzker, 973 F.3d at 763
(“The district court appropriately looked to Jacobson for guidance, and so do we.”). The
circuit held that “Jacobson t[ook] off the table any general challenge” to an executive order
that subjected religious gatherings to recommended limits on gatherings, rather than
mandatory ones. Id. at 763-64. The Illinois governor implemented “an order designed to
address a serious public-health crisis,” and Jacobson afforded broad deference “[a]t least
at this stage of the pandemic.” Id.
That decision was almost ten months ago—in terms of the law very recent, but in
terms of this ever-evolving health crisis before the proverbial rinderpest. We are no
longer at the same stage of the COVID-19 pandemic; indeed, some—like the students—
argue that the pandemic is effectively over. And since this circuit’s Pritzker decision, more
cases bearing on the subject of public health in the COVID-19 pandemic have arrived.
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One such decision—and one heavily briefed by the parties—is Roman Catholic
Diocese of Brooklyn v. Cuomo, 141 S. Ct. 63 (2020). In Cuomo, the State of New York adopted
capacity restrictions on religious institutions that treated them less favorably than socalled “essential” businesses, id. at 66, including liquor and hardware stores, id. at 69
(Gorsuch, J., concurring). Cuomo applied strict scrutiny because the law targeted religious
practice contrary to the First Amendment, as incorporated against the states by the
Fourteenth Amendment, and enjoined the limitations, saying they were not narrowly
tailored to fulfill the state’s compelling interest in controlling the spread of COVID-19. Id.
at 67 (majority opinion).
Cuomo enhanced the law’s focus under the First Amendment. See Cassell, 990 F.3d
at 543 (citing Cuomo for the proposition that “[i]ntervening authority from the Supreme
Court offers plaintiffs a greater prospect for success on the merits of their First
Amendment claim than either the district court or we had expected”). So this begs
another question: to what extent has Cuomo—if any—impacted the broad deference the
court would seemingly afford a state during a pandemic under Jacobson to act in the
interest of public health? Cuomo’s majority opinion never referenced Jacobson.
The students read Cuomo as implicitly overruling Jacobson, or at least as abrogating
it. Though the Supreme Court may overrule a case without explicitly saying so, see Levine
v. Heffernan, 864 F.2d 457, 461 (7th Cir. 1988), this is a tall task. Before a federal court
concludes that the Supreme Court has implicitly overruled a prior decision, it must be
“certain or almost certain that the decision or doctrine would be rejected by the higher
court if a case presenting the issue came before it.” Olson v. Paine, Webber, Jackson & Curtis,
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Inc., 806 F.2d 731, 741 (7th Cir. 1986). This high bar is rarely met. Id. It isn’t met here.
Cuomo and Jacobson involved entirely different modes of analysis, entirely different rights,
and entirely different kinds of restriction. See Cuomo, 141 S. Ct. at 70 (Gorusch, J.,
concurring) (saying the same). “Jacobson applied what would become the traditional legal
test associated with the right at issue”—exactly what Cuomo did. Id. The cases walk handin-hand.
This history isn’t all rosy. Unsuccessful thus far, the students turn to Buck v. Bell,
274 U.S. 200 (1927). In a rather infamous case, an eight-member majority, save for one
dissenting justice, upheld the involuntary sterilization of a woman based on a Virginia
law that rested on faulty science and public support for “eugenics”—the repulsive notion
that the human race could be improved by controlling reproduction from those with
developmental challenges, mental illness, or criminal histories. Citing Jacobson for the
principle that “compulsory vaccination is broad enough to cover cutting the Fallopian
tubes,” and offering the chilling justification that “[t]hree generations of imbeciles are
enough,” the majority upheld the law against a Fourteenth Amendment challenge. Id. at
207. This case isn’t Buck; and one over-extension of Jacobson merely counsels once more
that the Constitution cannot be cut loose even now, in a pandemic’s seeming twilight.
Cuomo, 141 S. Ct. at 68.
Jacobson was written before the modern tiers of constitutional scrutiny, so a
legitimate question is the extent to which Jacobson applies with full force today. This is a
topic of some debate. See, e.g., id. at 70 (Gorsuch, J., concurring) (“Jacobson didn’t seek to
depart from normal legal rules during a pandemic, and it supplies no precedent for doing
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so.”); Calvary Chapel Dayton Valley v. Sisolak, 140 S. Ct. 2603, 2608 (2020) (Alito, J.,
dissenting) (“it is a mistake to take language in Jacobson as the last word on what the
constitution allows public officials to do during the COVID-19 pandemic”); Big Tyme Inv.,
LLC v. Edwards, 985 F.3d 456, 470-71 and n.3 (5th Cir. 2021) (Willett, J., concurring) (“I am
not the first to express doubts about Jacobson”); S. Bay United Pentecostal Church v. Newsom,
959 F.3d 938, 943 n.2 (9th Cir. 2020) (Collins, J., dissenting) (“I am unable to agree with
the Fifth Circuit’s conclusion that Jacobson instructs that all constitutional rights may be
reasonably restricted to combat a public health emergency.”) (quotations omitted), cert.
denied, 140 S. Ct. 1613 (2020). No Supreme Court opinion has overruled or abrogated
Considering the modern tiers of constitutional scrutiny, the court reads Jacobson
and Cuomo harmoniously, appreciating their respective spheres. Though Jacobson was
decided before tiers of scrutiny, it effectively endorsed—as a considered precursor—
rational basis review of a government’s mandate during a health crisis. See Jacobson, 197
U.S. at 31; see also Cuomo, 141 S. Ct. at 70 (Gorusch, J., concurring). In its words, if a law
purporting to be enacted to protect public health “has no real or substantial relation to
[that legitimate aim]” or if the law proves “a plain, palpable invasion of rights secured by
the fundamental law,” the court’s job is to give effect to the Constitution. Jacobson, 197
U.S. at 31. Should the court have this melding of history and modernity wrong in
faithfully adhering to the Fourteenth Amendment’s plain original meaning of “life” and
“liberty,” comfort should come in knowing that Jacobson, whether rational basis review
by any other name, leads to the same result today.
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This view remains consistent with the right at stake in Jacobson: though a true
“liberty” proved at stake—the right to refuse a vaccine during a smallpox epidemic—this
interest in bodily autonomy, though protected by the Constitution, wasn’t fundamental
under the Constitution to require greater scrutiny than rational basis review. See Sweeney,
767 F.3d at 668 (rational basis review for infringements on non-fundamental rights). At
the same time, Jacobson didn’t hold that the government’s authority in a pandemic
balloons for it do whatever it wants in the name of public safety.
Jacobson instead counseled that federal courts should require a rational relation to
a legitimate interest in public health. See Jacobson, 197 U.S. at 31; Cuomo, 141 S. Ct. at 70
(Gorsuch, J., concurring). That Cuomo imposed heightened scrutiny of the government’s
interference with the free exercise of religion—a fundamental right under the First
Amendment—was presciently contemplated a century beforehand by Jacobson: a court
should intervene if a state imposes a regulation that is “beyond all question, a plain,
palpable invasion of rights secured by the fundamental law.” Jacobson, 197 U.S. at 31
(emphasis added). Because Cuomo involved a fundamental right, a “right secured by
the fundamental law” under today’s jurisprudence, the court intervened. See Cuomo, 141
S. Ct. at 67; see also Glucksberg, 521 U.S. at 721 (Fourteenth Amendment forbids the
government to infringe “fundamental” liberty interests at all, unless it has narrowly
tailored its law to serve a compelling state interest). The Constitution’s original meaning
should be so enduring.
The university seems to argue that Jacobson gave even more deference than rational
basis review during a public health crisis, but not fairly so; and, even then, Jacobson cannot
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be taken once more too far. See, e.g., Big Tyme, 985 F.3d at 467; ARJN #3 v. Cooper, __ F.
Supp.3d __, 2021 U.S. Dist. LEXIS 22286, 19 (M.D. Tenn. Feb. 5, 2021); Let Them Play MN
v. Walz, __ F. Supp.3d __, 2021 U.S. Dist. LEXIS 23485, 15 (D. Minn. Feb. 8, 2021); Culinary
Studios, Inc. v. Newsom, __ F. Supp.3d __, 2021 U.S. Dist. LEXIS 23775, 38-39 (E.D. Cal.
Feb. 8, 2021); Oakes v. Collier Cnty., __ F. Supp.3d __, 2021 U.S. Dist. LEXIS 15174, 4 n.4
(M.D. Fla. Jan. 27, 2021); M. Rae, Inc. v. Wolf, __ F. Supp.3d __, 2020 U.S Dist. LEXIS 241961,
16 n.25 (M.D. Pa. Dec. 23, 2020); Denver Bible Church v. Azar, 494 F. Supp.3d 816, 829 (D.
Colo. 2020); AJE Enterprise LLC v. Justice, 2020 U.S. Dist. LEXIS 222186, 12 (N.D. W. Va.
Oct. 7, 2020).
Jacobson doesn’t justify blind deference to the government when it acts in the name
of public health or in a pandemic. For instance, the decision left the door open for people
with legitimate medical concerns to challenge the vaccine mandate. See Jacobson, 197 U.S.
at 38-39. And the deference owed to the States during a pandemic or public health crisis
under Jacobson doesn’t extend indefinitely. See Pritzker, 973 F.3d at 763.
[A]t the outset of an emergency, it may be appropriate for courts to tolerate
very blunt rules. . . . [B]ut a public health emergency does not give . . . public
officials carte blanche to disregard the Constitution for as long as the medical
problem persists. As more medical and scientific evidence becomes
available, and as States have time to craft policies in light of that evidence,
courts should expect policies that more carefully account for constitutional
Calvary Chapel, 140 S. Ct. at 2605 (Alito, J., dissenting); accord Cassell, 458 F. Supp.3d at
993-94 (“courts must remain vigilant, mindful that government claims of emergency have
served in the past as excuses to curtail constitutional freedoms.”).
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In short, the Constitution doesn’t permit the government to declare a never-ending
public emergency and expand its powers arbitrarily. See Belcher v. Norton, 497 F.3d 742,
753 (7th Cir. 2007) (“substantive due process . . . affords protection of the individual
against arbitrary action of government”). Instead, as our country and communities
progress through a pandemic, the government must continually update its practices in
light of the most recent medical and scientific developments. And a law or policy should
be written with a mindset that medicine and science, and the circumstances that they
create, will evolve, and so must the law or policy evolve or be revisited in amendment.
In sum, the law today recognizes Jacobson as a precursor to rational basis review.
This is consistent with statements of many justices who continue to acknowledge Jacobson
as good law, albeit with constitutional restraint.74 Government action that infringes on
the liberty interest here, as in Jacobson, is subject to rational basis review. See Sweeney, 767
F.3d at 668.
See, e.g., Democratic Nat’l Comm. v. Wisconsin State Legislature, 141 S. Ct. 28, 43 (2020) (Kagan, J., dissenting).
(“To be sure, deference is usually due to a legislature’s decisions about how best to manage the COVID
pandemic.”) (citing South Bay, 140 S. Ct. at 1613-14) (Roberts, C.J., concurring in denial of an injunction
seeking to prevent a COVID-19 executive order); South Bay, 140 S. Ct. at 1613 (Roberts, C.J., concurring);
Calvary Chapel, 140 S. Ct. at 2608 (Alito, J., dissenting) (“Language in Jacobson must be read in context”); id.
at 2614 (Kavanaugh, J., dissenting); Cuomo, 141 S. Ct. at 71 (Gorsuch, J., concurring); Cuomo, 141 S. Ct. at 79
(Sotomayor, J., dissenting) (courts “play a deadly game in second guessing the expert judgment of health
officials about the environments in which a contagious virus, now infecting a million Americans each week,
spreads most easily”); Glucksberg, 521 U.S. at 742 (Stevens, J., concurring) (“As Justice Brennan pointed out
in his Cruzan dissent, we have upheld legislation imposing punishment on persons refusing to be
vaccinated . . . . In most cases, the individual’s constitutionally protected interest in his or her own physical
autonomy, including the right to refuse unwanted medical treatment, will give way to the State’s interest
in preserving human life.”).
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Defining the Right & Constitutional Analysis.
The students assert a right to refuse the vaccine, saying the mandate infringes on
their bodily autonomy and medical privacy. Indiana University throws a challenge flag
here. To it, these students are merely saying they have a right to refuse a vaccine so that
they may attend college. The university says the right being infringed then isn’t the right
to refuse a vaccine, but the right to attend college. Indeed, if they choose to forego college
at Indiana University, there is no vaccine requirement. To the university, the students
aren’t being forced to take the vaccination against their will; they can go to college
elsewhere or forego college altogether. If this case were merely that, merely the right to
attend university, this state action wouldn’t trample on their rights. There is no
fundamental or constitutional right to a college education, see, e.g., Charleston v. Bd. of
Trustees, 741 F.3d 769, 774 (7th Cir. 2013); Bissessur v. Ind. Univ. Bd. of Trustees, 581 F.3d
599, 601 (7th Cir. 2009); Williams v. Wendler, 530 F.3d 584, 589 (7th Cir. 2008), much less
one at a particular institution.
But that’s not what this case concerns, and that’s not the liberty at stake. The
“unconstitutional conditions doctrine” forbids the university from pulling the rug out
from under the students in a roundabout way. Under this doctrine, argued by the
students as “coercion,” “the government may not deny a benefit to a person because he
exercises a constitutional right.” Koontz v. St. Johns River Water Mgmt. Dist., 570 U.S. 595,
604 (2013) (citations omitted); Regan v. Taxation with Representation of Wash., 461 U.S. 540,
545 (1983). This doctrine protects constitutional rights “by preventing the government
from coercing people into giving them up.” Koontz, 570 U.S. at 604. It “aims to prevent
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the government from achieving indirectly what the Constitution prevents it from
achieving directly.” Planned Parenthood of Ind. v. Comm’r, 699 F.3d 962, 986 (7th Cir. 2012).
The students say this state actor is denying a benefit—a public university education—
because they are exercising a constitutional right to refuse a vaccine.
The first step in an unconstitutional condition claim “is to identify the nature and
scope of the constitutional right arguably imperiled by the denial of a public benefit.” Id.
Here, the Fourteenth Amendment “liberty” at stake is a college student’s right to refuse
a vaccine, today at this stage of the pandemic [Tr. 26, 30-31]. The Supreme Court has
assumed (using its word) and strongly suggested that individuals have a constitutional
right to refuse unwanted medical treatment, see, e.g., Cruzan v. Director, Missouri Dept. of
Health 497 U.S. 261, 279 (1990); Glucksberg, 521 U.S. at 720. Cruzan held that a competent
individual had a constitutional right to refuse unwanted lifesaving hydration and
nutrition; and Glucksberg recognized that an individual had a liberty interest in refusing
unwanted lifesaving medical treatment, though not any fundamental right to assisted
suicide. See Cruzan, 497 U.S. at 279; Glucksberg, 521 U.S. at 728.
But in these, and in other cases, this liberty interest has remained confined either
by duly enacted and constitutional state laws or the state’s legitimate interests that it had
rationally pursued in regulation. See also Washington v. Harper, 494 U.S. 210, 221-22 (1990)
(prisoner has a “significant liberty interest in avoiding the unwanted administration of
antipsychotics drugs under the Due Process Clause . . . [but] no greater right than that
recognized under state law”); Vitek v. Jones, 445 U.S. 480, 492 (1980) (“Compelled
treatment in the form of mandatory behavior modification programs . . . was a proper
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factor to be weighed by the District Court. . . . Were an ordinary citizen to be subjected
involuntarily to these consequences, it is undeniable that protected liberty interests
would be unconstitutionally infringed absent compliance with the procedures required
by the Due Process Clause.”); Ingraham v. Wright, 430 U.S. 651, 673, 683 (1977) (“Among
the historic liberties so protected was a right to be free from, and to obtain judicial relief
for, unjustified intrusions on personal security. . . . The Eighth Amendment’s prohibition
against cruel and unusual punishment is inapplicable to school paddlings, and the
Fourteenth Amendment’s requirement of procedural due process is satisfied by Florida’s
preservation of common-law constraints and remedies.”)
The rights recognized (or assumed) in these cases weren’t “simply deduced from
abstract concepts of personal autonomy.” Glucksberg, 521 U.S. at 725. They were rooted
in longstanding common law rules or legal traditions consistent with this Nation’s
history. See id. The students, quite skillfully represented in this emergency setting, offer
no preliminary record of such historic rules, laws, or traditions that would facilitate the
court’s announcement, now in mere days from receiving this case, that a right to refuse a
vaccine is anything more than a significant liberty under the Fourteenth Amendment.
The dearth of this record isn’t a passing point. Indeed, both Cruzan and Glucksberg
were limited to an individual’s choice related to the refusal of lifesaving subsistence or
medical treatment—with no ramifications to the physical health of others. Vaccines
address a collective enemy, not just an individual one. Indeed, “the elimination of
communicable diseases through vaccination [is] one of the greatest achievements of
public health in the 20th century,” Bruesewitz v. Wyeth LLC, 562 U.S. 223, 226 (2011) (Scalia,
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J.) (citation and quotations omitted), and it continues to be so now in this century. A
vaccine is implemented as a matter of public health, and historically hasn’t been
constitutionally deterred from state mandate. See, e.g., Zucht, 260 U.S. at 176-77; Jacobson,
197 U.S. at 30-31.
In the backdrop of the Fourteenth Amendment’s ratification in 1868, for instance,
England had already passed its first compulsory vaccination act for smallpox in 1853 (and
so had many countries). See Jacobson, 197 U.S. at 31, n.1. Science wasn’t absolute or
infallible at that time—nor is it today. But the “possibility that the belief may be wrong,
and that science may yet show it to be wrong, is not conclusive; for the legislature has the
right to pass laws which, according to the common belief of the people, are adapted to
prevent the spread of contagious diseases.” Id. at 35. Appreciating the relative risks of
vaccines, they nonetheless “are effective in preventing outbreaks of disease only if a large
percentage of the population is vaccinated.” Wyeth, 562 U.S. at 227.
Added comfort comes from the consistent use of rational basis review to assess
mandatory vaccination measures. See, e.g., Prince v. Massachusetts, 321 U.S. 158, 166-67
(1944) (parent “cannot claim freedom from compulsory vaccination for the child more
than for himself on religious grounds” and “[t]he right to practice religion freely does not
include liberty to expose the community or the child to communicable disease or the
latter to ill health or death”); Zucht, 260 U.S. at 176-77; Jacobson, 197 U.S. at 30-31; Phillips
v. City of New York, 775 F.3d 538, 542-43 (2d Cir. 2015); Workman v. Mingo Cnty. Bd. of Educ.,
419 F. Appx. 348, 355-56 (4th Cir. 2011); W.D. v. Rockland Cnty., __ F. Supp.3d __, 2021 U.S.
Dist. LEXIS 33515, 74 (S.D.N.Y. Feb. 22, 2021); Doe v. Zucker, __ F. Supp.3d __, 2021 U.S.
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Dist. LEXIS 28937, 111 (N.D.N.Y. Feb. 17, 2021); Connecticut Citizens Defense League, Inc. v.
Lamont, 465 F. Supp.3d 56, 72 (D. Conn. 2020); Middleton v. Pan, 2016 U.S. Dist. LEXIS
197627, 20 (C.D. Cal. Dec. 15, 2016); George v. Kankakee Cmty. Coll., 2014 U.S. Dist. LEXIS
161379, 8-9 (C.D. Ill. Oct. 27, 2014), recommendation adopted, 2014 U.S. Dist. LEXIS 160737,
1-2; Boone v. Boozman, 217 F. Supp.2d 938, 954 (E.D. Ark. 2002).
Given over a century’s worth of rulings saying there is no greater right to refuse a
vaccination than what the Constitution recognizes as a significant liberty, the court
declines the students’ invitation to extend substantive due process to recognize more than
what already and historically exists. See Glucksberg, 521 U.S. at 721; Harper, 494 U.S. at
221-22; Prince, 321 U.S. at 166-67; Zucht, 260 U.S. at 176-77; Jacobson, 197 U.S. at 30-31.
Quite separately from this, the Constitution never provides a fundamental right to
a collegiate education. Nor does it secure as a fundamental liberty a student’s right to
attend a public university no matter his or her vaccinated status. The court isn’t saying a
student doesn’t have the right to choose. Of course every individual does—subject to the
state’s reasonable measures designed to pursue legitimate ends of disease control or
The students argue that the university’s vaccine mandate doesn’t provide for
informed consent. “The notion of bodily integrity has been embodied in the requirement
that informed consent is generally required for medical treatment.” Cruzan, 497 U.S. at
269. Informed consent “entails an opportunity to evaluate knowledgeably the options
available and the risks attendant upon each.” Canterbury v. Spence, 464 F.2d 772, 780 (D.C.
Cir. 1972). The students acknowledge that, for medical products under an EUA like the
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three COVID-19 vaccines, HHS must establish conditions to facilitate informed consent.
See 21 U.S.C. § 360bbb-3(e)(1)(A)(ii). HHS must ensure that individuals taking the vaccine
are informed “that the Secretary has authorized the emergency use of the product,” “of
the significant known and potential benefits and risks of such use, and of the extent to
which such benefits and risks are unknown,” and “of the option to accept or refuse
administration of the product, of the consequences, if any, of refusing administration of
the product, and of the alternatives to the product that are available and of their benefits
and risks.” Id.
The students admit that the informed consent requirement under the EUA statute
only applies to medical providers. The university isn’t directly administering the vaccine
to its students; instead, it is requiring students to obtain the vaccine from a medical
provider and to attest that they have been vaccinated, save for certain exemptions. The
students will be informed of the risks and benefits of the vaccine and of the option to
accept or refuse the vaccine by their medical providers. See id. The university isn’t forcing
the students to undergo injections. The situation here is a far cry from past blunders in
medical ethics like the Tuskegee Study.75
The university is presenting the students with a difficult choice—get the vaccine
or else apply for an exemption or deferral, transfer to a different school, or forego school
for the semester or altogether. But this hard choice doesn’t amount to coercion. The
See CDC, The U.S. Public Health Service Syphilis Study at Tuskegee (as part of a study on the history of
untreated syphilis, “researchers did not collect informed consent from participants and they did not offer
treatment, even after it was widely available”), https://www.cdc.gov/tuskegee/index.html (last visited
July 16, 2021).
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students taking the vaccine are choosing it among other options, and before the shot
reaches their arms, they are made aware of the risks and the option to refuse.
One last point before moving on. As a final push, the students argue that the
vaccination requirement violates their free exercise of religion. The First Amendment
says “Congress shall make no law . . . prohibiting the free exercise” of religion. U.S. Const.
amend. I. The Supreme Court has declared this right to exercise religion as fundamental
and subject to strict scrutiny. See Cantwell v. Connecticut, 310 U.S. 296, 303 (1940). But the
Constitution also permits general regulations that incidentally burden religious practices:
the “right of free exercise does not relieve an individual of the obligation to comply with
a valid and neutral law of general applicability on the ground that the law proscribes (or
prescribes) conduct that his religion prescribes (or proscribes).” Employment Division v.
Smith, 494 U.S. 872, 879 (1992) (quotations omitted). Neutral and generally applicable
regulations need only be supported by a rational basis. Ill. Bible Colleges Ass’n v. Anderson,
870 F.3d 631, 639 (7th Cir. 2017).
The vaccine mandate is a neutral rule of general applicability. It applies to all
students, whether religious or not. It doesn’t discriminate among religions. Indeed, the
university has chosen to enable the practice of religion by providing a religious exemption
to this vaccination requirement—one that the university, on this record, has freely
granted to students if they request it, no questions asked. This is consistent with the
Constitution. See Nikolao v. Lyon, 875 F.3d 310, 316 (6th Cir. 2017) (religious plaintiff had
no constitutional right to an exemption from mandatory vaccination law for public school
students, though state provided one); Phillips, 775 F.3d at 543 (state “could
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constitutionally require that all children be vaccinated in order to attend public school. .
. . [but the State went] beyond what the Constitution requires by allowing an exemption
for parents with genuine and sincere religious beliefs”); see also Workman, 419 F. Appx. at
356; Whitlow v. California, 203 F. Supp.3d 1079, 1084 (S.D. Cal. 2016); Boone, 217 F. Supp.2d
at 954. Indiana University adopted a religious exemption, despite a religious-neutral
vaccine mandate, which the law views as a matter of grace. Indeed, six of the eight
students here applied for just such a religious exemption and obtained one.
In short, based on this analysis, all roads effectively lead to rational basis review:
Jacobson as a precursor to or stand-alone iteration of it, the modern tiers of constitutional
scrutiny, the unconstitutional conditions doctrine, and the First Amendment as applied
through the Fourteenth Amendment to this state actor. And to this road once traveled the
court now turns.
On This Preliminary Record, Non-Exempt Students Haven’t Shown a
Likelihood of Success on their Claim that Indiana University Lacks a
Rational Basis for Its Vaccine Mandate.
Determining that the students have a liberty interest under the Fourteenth
Amendment’s due process clause doesn’t end the analysis. See Cruzan, 497 U.S. at 278. To
decide whether the students’ constitutional rights have been violated, or more
appropriately whether they are likely to succeed on such a claim, the court must balance
their liberty against the relevant state interests in accord with the Constitution. See id.
Two students aren’t exempt from the COVID-19 vaccine mandate: Natalie Sperazza and
Margaret Roth. They assert a right to refuse the vaccine, saying the mandate infringes on
their bodily autonomy and medical privacy.
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“Stemming the spread of COVID-19 is unquestionably a compelling interest.”
Cuomo, 141 S. Ct. at 67 (majority opinion). According to the federal government and the
State of Indiana, a state of emergency persists related to COVID-19, all the while
restrictions are being scaled back gradually. Recognizing today’s status of this pandemic,
neither health professionals, government representatives, nor this court may say public
health vis-à-vis COVID-19 has waned from being a legitimate state interest. Improved it
undoubtedly has—today seems a world altogether different from last year—but public
health remains a legitimate interest of the state to pursue. Indiana University too has a
legitimate interest in promoting the health of its campus communities—students, and not
least the faculty and staff who come daily in contact with them.
The students argue that the pandemic is basically over, but this goes against
current proclamations from the Secretary of Health and Human Services, the Indiana
State Department of Health, Governor Eric Holcomb, and the CDC, all then supported
for institutions of higher learning by the U.S. Department of Education and the American
College Health Association.76 In Indiana (and nationally), the trend line remains sharply
down (since winter) in terms of both new cases and deaths, though the recent snapshot
of seven-day lookbacks proves nearly triple what it was just when this case commenced.
See, e.g., U.S. Dep’t of Educ., ED COVID-19 Handbook, Volume 3: Strategies for Safe Operation and Addressing
the Impact of COVID-19 on Higher Education Students, Faculty, and Staff 9 (June 2021), available at [Ex. 116 at
7], https://www2.ed.gov/documents/coronavirus/reopening-3.pdf (“COVID-19 vaccination is the
leading prevention strategy [institutions of higher learning] can use to return to normal operations.”); Am.
College Health Ass’n, ACHA Guidelines: American College Health Association Recommends COVID-19
Vaccination Requirements for All On-Campus College Students in Fall 2021 (Apr. 29, 2021),
https://www.acha.org/ACHA/About/ACHA_News/ACHA_Recommends_COVID19_Vaccination_Requirements_for_Fall_2021.aspx. Though it appears many public universities, including
those in the State of Indiana, are ACHA members, Indiana University is not. The guidance is nonetheless
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It isn’t unreasonable to believe that, absent concerted vaccination, the fall and winter
months will prove more arduous than these summer months for the university [Ex. 129
at 32]. Vastly improved, yes; out of the woods we aren’t, not on this preliminary record.
The students argue that the bell curve that depicts ongoing cases and deaths from
this pandemic’s outset mirrors the CDC’s continuum of pandemic phases that directs
more conservative measures, not more draconian ones [see, e.g., Exs. 212, 222, 230-231].
The students call this pandemic in the “deceleration” or “preparation” intervals—terms
of art that define its waning stages. Deceleration occurs when state or local health officials
rescind community mitigation measures because no new cases are occurring or are
occurring infrequently; and preparation occurs when the pandemic is declared ended
because evidence indicates that the disease is transitioning to seasonal patterns of
transmission [Ex. 231]. The overall trend line may well support a seeming deceleration
[cf. Exs. 222, 319]; but Indiana University insisting on vaccinations for its campus
communities is rationally related to ensuring the public health of students, faculty, and
staff this fall. Even under the university’s pandemic and infectious disease action levels
[Ex. 212], the university must continue to consult CDC and Indiana State Department of
Health standards; and those today favor vaccination.
Let’s not forget why we are here at this more promising stage of the pandemic,
July 18, 2021. Antibody resistance developed naturally from prior cases has been a
contributor to be sure; but, materially, improvement has come because of vaccinations—
nationally over 161 million complete (over 337 million doses) and statewide nearly 3
million complete (and over 5.7 million doses). The vaccination campaign has markedly
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curbed the pandemic. In fact, certain age-stratified, agent-based modeling of COVID-19
has concluded that another 279,000 deaths and nearly 1.25 million more hospitalizations
would have occurred by the end of June 2021 but for the vaccines.77 Stemming illness,
hospitalizations, or deaths at the university level hardly proves irrational.
It isn’t a foregone conclusion that this is overkill. This pandemic continues to
evolve, and medicine and science with it. Science is a process in search of fact. One such
moving target is the Delta variant (B.1.617.2). A mere four days ago Indiana reported 612
COVID cases—the highest count in more than six weeks (since May 27, 2021)—that health
officials attributed largely to the Delta variant and the unvaccinated population. Though
this daily case count is much lower than at the pandemic’s height, the CDC, Indiana’s
State Department of Health, and epidemiologists have identified the Delta variant of
particular lingering concern.78 The CDC labeled Delta a “variant of concern” in midJune.79 Current science shows it more virulent and transmissible. A peer-reviewed study
from scientists (issued July 8, 2021) found that the Delta variant has mutations that allow
it to evade certain natural antibodies, with vaccination proving the best protection [Ex.
See Alison Galvani et al., Deaths and Hospitalizations Averted by Rapid U.S. Vaccination Rollout
(Commonwealth Fund, July 2021), https://doi.org/10.26099/wm2j-mz32.
See Shari Rudavsky, Delta Variant on the Rise in Indiana, State Health Officials Say, IndyStar (July 9, 2021,
https://www.indystar.com/story/news/health/2021/07/09/covid-delta-variant-riseindiana-state-health-officials-say/7908502002/ (“Not only is the Delta variant more readily transmitted
from person to person, there’s some indication it may cause more severe disease, said Indiana State Health
Commissioner Dr. Kris Box.”).
79 See See CDC, SARS-CoV-2 Variant Classifications and Definitions (July 13, 2021),
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319].80 Reports of surges of Delta cases among the 12-29 age group have occurred.81 For
now, Indiana University has reasonably concluded that the safety and public health of its
campus communities can be augmented by the vaccines [id.]. See Gonzales, 550 U.S. at 163
(citing Jacobson, 197 U.S. at 30-31) (the law gives “wide discretion to pass legislation in
areas where there is medical and scientific uncertainty”).
Indiana University reasonably believes the vaccine promotes the safety of not only
its students, but that of its entire community. This wasn’t (and still isn’t) a decision taken
lightly. It wasn’t a decision reached overnight. It wasn’t a decision taken by some fly-bynight committee undetached from the current science, the current progress of the fight
See Delphine Planas et al., Reduced Sensitivity of SARS-CoV-2 Variant Delta to Antibody Neutralization,
Nature doi: 10.1038/s41586-021-03777-9, 3 (July 8, 2021) (online ahead of print),
https://www.nature.com/articles/s41586-021-03777-9_reference.pdf (“[A] single dose of Pfizer or
AstraZeneca was either poorly or not at all efficient against Beta and Delta variants. Both vaccines
generated a neutralizing response that efficiently targeted variant Delta only after the second dose.”)
According to Dr. Beeler, the data show that 50 percent of individuals had antibodies to the Beta variant and
47 percent had antibodies to the Delta variant one year after natural infection, whereas those who had
vaccination after natural infection maintained 100 percent antibodies to both variants a year later [Ex. 319
¶ 1]. According to Yale Medicine, the Delta variant is 50 percent more transmissible. See also VenkataViswanadh Edara et al., Infection and Vaccine-Induced Neutralizing-Antibody Responses to the SARS-CoV-2
2021) https://www.nejm.org/doi/full/10.1056/NEJMc2107799; Kathy Katella, Yale Med., 5 Things to
Know About the Delta Variant (July 15, 2021), https://www.yalemedicine.org/news/5-things-to-knowdelta-variant-covid.
See See Ian Mount et al., The Kids are (not) Alright: Europe Sounds the Alarm as Delta Variant Soars Among
Teens and 20-Somethings, Fortune (July 8, 2021, 11:58 AM), https://fortune.com/2021/07/08/kidsvulnerable-covid-delta-variant-vaccinated-europe/ (seeing surge of Delta cases among the 12-29 age
group); see also Public Health England, SARS-CoV-2 Variants of Concern and Variants under Investigation in
England: Technical Briefing 17, 15 (June 25, 2021), https://www.nature.com/articles/s41586-021-037779_reference.pdf. A recent United Kingdom study, albeit still abstracted, concluded that most Delta
infections in a younger group (age 5-49) occurred in the unvaccinated population. See Steven Riley et al.,
REACT-1 Round 12 Report: Resurgence of SARS-CoV-2 Infections in England Associated with Increased Frequency
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against the pandemic, or experience and training in relevant fields of study. The restart
committee was led by Indiana University’s Executive Vice President for University
Clinical Affairs and the School of Medicine’s Dean. The committee consisted of seven
MDs, some with additional degrees in public health or other PhDs, and others with
graduate degrees in public health, risk mitigation, law, and ethics [Ex. 300 at 5]. Of its 15
members, two were deans of public health and others were experts in public health,
epidemiology, virology, and other relevant areas of the health sciences, including health
equity [Ex. 116 ¶ 23]. The committee met regularly and considered a wide variety of
sources and information [id. ¶ 24].
A mere sampling of presentations from committee meetings from December 8,
2020 to April 6, 2021 [Exs. 302-317] shows the committee focused on COVID-19 evolution;
EUA data; reactogenicity data; communications with the Indiana State Department of
Health; CDC guidelines and updates; university-wide surveillance testing and data; data
trends based on vaccinated and unvaccinated individuals; on-campus and off-campus
transmission events; morbidity and mortality figures; efficacy of mitigation efforts on and
off campus; international, national, state, county, and school vaccine uptake data; vaccine
efficacy against variants; vaccine risk data; vaccine hesitancy surveys and campus
opinion polling; and policies and requirements of other universities across the country
[see also Ex. 301 ¶ 2]. In addition, four MDs from this committee presented near-weekly
from December 2020 to June 2021 to Indiana University’s Executive Academic Leadership
Council, including the President and Executive Vice Presidents as part of the medical
response team’s ongoing COVID-19 evaluation efforts [Id. ¶ 5]. The process ultimately
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filtered through the judgment of the Board of Trustees. This was a deliberative decision
based on a wealth of scientific, medical, empirical, and industry-wide data.
For the impact of this vaccine mandate, the students focus only on the student
body; and that is certainly an important part of the analysis here. The students argue that
the fatality rate for healthy individuals age 20-49 is far less than older individuals [see,
e.g., Ex. 117 at 21-24; Ex. 243]. Dr. McCullough calls the mortality rate 0.15 percent [Ex.
241 ¶ 3]. He testifies that 16 deaths of young adults (aged 18-29) occurred in 2020, but
none thus far in 2021 [Ex. 117 ¶ 34]. The students point out that the university’s student
body had one death last year [id. ¶ 25]. Indiana University reasonably views a 0.15 percent
death rate as unacceptable for its communities, particularly given the safe preventative
measure of a vaccine [Ex. 319 ¶ 4]. At approximately 90,000 students, that rate would risk
135 student lives, not accounting for other mitigation efforts to the better or those with
immunocompromising conditions to the worse. The university’s student population is
not a homogenous group of just young healthy adults [id.].
In addition, the student’s position overlooks the larger Indiana University
community. Dr. McCullough, in fairness, takes a wider snapshot yet, pointing to a
longitudinal serosurvey (blood sampling) of community residents near Pennsylvania
State University suggesting that students’ return in August 2020 had limited
transmissible effect on the local community [Ex. 117 ¶ 29-30].82 But Indiana University’s
perspective was more intimate. The university analyzed the number of individuals
See Callum R. K. Arnold et al., SARS-CoV-2 Seroprevalence in a University Community: A Longitudinal Study
of the Impact of Student Return to Campus on Infection Risk Among Community Members, medRxiv (Feb. 14,
2021) (non-peer reviewed pre-print), https://pubmed.ncbi.nlm.nih.gov/33619497/.
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within its campus population known to have increased risk factors for COVID-19 and
determined that over 8,500 faculty and staff remained at increased risk of complications
if they contracted the disease [Ex. 116 ¶ 26], with the ongoing risk of asymptomatic spread
that vaccines help address [Ex. 129 at 53-54]. Faculty and staff at Indiana University who
have daily contact with students represent an even broader demographic than just the
student body, and this policy was intended to protect them too. The court credits Dr.
Carroll and Dr. Beeler over Dr. McCullough on this point given their firsthand
knowledge of Indiana University’s specific circumstances.
The university’s policy has broad support within its community. As of June 25,
2021, over 42,000 students had received the vaccine; and that number has no doubt grown
[Ex. 116 ¶ 46]. Two university faculty councils—elected representative bodies interested
in the quality of learning and student life—issued statements in support [id. ¶ 47]. The
staff council at Indiana University’s main campus in Bloomington likewise endorsed the
policy [id. ¶ 49]. The graduate and professional student government also issued a
resolution supporting the policy [id. ¶ 50]. Eight students have filed this lawsuit, and
perhaps others await this ruling to decide. Under the circumstances, on this preliminary
record, the law respects the right of this university community to self-govern reasonably.
To that point, no one has argued that Indiana University’s policy is ultra vires.
Indiana’s General Assembly endowed the university’s Board of Trustees to act in the
“best interests of the state and the state educational institution,” Ind. Code § 21-40-3-1(b),
including the power “to prevent unlawful or objectionable acts that . . . violate the
reasonable rules and standards of the [university] designed to protect the academic
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community from . . . conduct presenting a serious threat to person or property of the
academic community,” Ind. Code § 21-39-2-3(b). The university remains answerable to
the legislature, particularly its coffers.
The Indiana General Assembly has prohibited a vaccine passport in this state, but
not a vaccine requirement. See Ind. Code § 16-39-11-5. Still, in assessing the
reasonableness of vaccination mandates, the law considers underlying legislative
authority. See Zucht, 260 U.S. at 175; Jacobson, 197 U.S. at 12-13; see also Washington, 494
U.S. at 221-22 (recognizing liberty interest under both state’s policy and due process
clause, but “no greater right than that recognized under state law”). On this preliminary
record, Indiana University faces still an “objectionable” and “serious threat” to the
“academic community” that its vaccination policy seeks reasonably to address for
campus health. See Zimmerman v. Bd. of Trustees of Ball State Univ., 940 F. Supp.2d 875, 89091 (S.D. Ind. 2013) (defining “objectionable”). This is consistent with the Fourteenth
Focusing on just mortality risk from COVID-19 leaves out much of the debate. Dr.
McCullough and Dr. Beeler (with Dr. Carroll), for instance, offer competing views on the
risks of the novel coronavirus and the risks of the vaccines [Exs. 115-117, 222, 319].83 This
is precisely the debate of medical professionals that state policymakers, including
The experts at times debate relatively modest side effects from vaccines after natural infection (e.g., fever
or fatigue), but these are self-limited and not dangerous [Ex. 319 ¶ 6], so the court addresses them no more
here. Even Dr. McCullough admits that other longstanding vaccines, including those mandated by state
law, have common side effects, such as a risk of a fever [Ex. 117 ¶ 56].
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authorized arms of the state, are best suited to resolve in setting policy for constituents,
including here for the students at Indiana University.
Without vaccination, college-aged students remain at risk for serious long-term
complication from COVID-19, including prolonged debilitating symptoms that interfere
with normal life such as myocarditis, reduced aerobic capacity, and brain damage [Ex.
319 ¶ 5].84 Long COVID remains a studied phenomenon. With Indiana reporting that
individuals aged 20-29 have had more positive cases than any other age demographic
[Ex. 115 ¶ 14], and with more than 260,000 cases linked to American college and
universities since January 1, 2021 [id. ¶ 17], this proves still a legitimate risk.85 Focusing
only on mortality disregards the serious compromise to the quality of life that face some
students who contract the virus [see also id. ¶ 10-11].
The students say the risks of the vaccine, especially at this stage and to their age
group, outweigh any benefits a vaccine might confer. These argued risks include
See Mark W. Tenforde et al., Symptom Duration and Risk Factors for Delayed Return to Usual Health Among
Outpatients with COVID-19 in a Multistate Health Care Systems Network — United States, March–June 2020,
69:30 Morbidity and Mortality Weekly Report 993, 997-98 (July 24, 2020),
COVID-19 illness can result in prolonged illness and persistent symptoms, even in young adults and
persons with no or few chronic underlying medical conditions.”); Giovanni Andrea Gerardo Crameri et
al., Reduced Maximal Aerobic Capacity after COVID-19 in Young Adult Recruits, Switzerland, May 2020, 25(36)
Euro. Surveillance 1, 2 (Sept. 10, 2020),
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7502899/pdf/eurosurv-25-36-2.pdf (“We observed a
statistically significant decrease in VO₂ max among COVID-19 convalescents compared with naive and
asymptomatically infected recruits”); Gwenaelle Douaud et al., Brain Imaging Before and After COVID-19 in
UK Biobank, medRxiv (Jun. 20, 2021) (not peer-reviewed pre-print),
https://www.medrxiv.org/content/10.1101/2021.06.11.21258690v2 (“In both cases we identified
significant (corrected-P<0.05) effects of COVID-19, primarily relating to loss of grey matter in cortical
areas directly connected to primary olfactory and gustatory cortex.”)
The New York Times has tracked coronavirus cases at American college and universities, though its
numbers have not been seemingly updated since May 26, 2021. See The New York Times, Tracking
Coronavirus Cases at U.S. Colleges and Universities,
https://www.nytimes.com/interactive/2021/us/college-covid-tracker.html (last visited July 18, 2021).
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myocarditis, clotting, death, and others [Ex. 117 ¶ 48-49]. Some of these concerns are
easier to assuage based on current science than others—and the court isn’t the final arbiter
of an evolving science, only of the law. The court must base today’s decision on the
snapshot of this preliminary record alone. It answers the question only whether the
students have made a strong showing that Indiana University failed to act reasonably in
achieving campus health to warrant the extraordinary remedy of a preliminary
That said, Dr. Beeler concludes that with millions of people getting the vaccine,
experts “have [a] much tighter lens than we normally would for any other vaccine in
history to identify some of those extremely rare concerns” [Ex. 128 at 80], and that
younger people have a “higher probability” of facing issues with COVID-19 infection
than after vaccination [id. 78]. All vaccine manufacturers conducted Phase 3 trials for
EUA that never revealed the risks the students have presented [id. 79].
Since then, reports have shown the risk of myocarditis (heart inflammation), while
present and something worthy of continued investigation, to be seemingly rare—one
study suggesting the risk is about eight in one million and the other study suggesting the
risk is about twenty in one million.86 This issue has garnered increasing attention. The
FDA reported CDC data (through May 31, 2021) of 475 cases of myocarditis (heart
inflammation) and pericarditis (inflammation of membrane around heart) in vaccinated
See Han W. Kim et al., Patients with Acute Myocarditis Following mRNA COVID-19 Vaccination, JAMA
Cardiol (June 29, 2021), https://jamanetwork.com/journals/jamacardiology/fullarticle/2781602; Israeli
Ministry of Health, Surveillance of Myocarditis (Inflammation of the Heart Muscle) Cases Between December 2020
and May 2021 (Feb. 6, 2021), https://www.gov.il/en/departments/news/01062021-03.
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individuals age 30 and younger [Ex. 117 ¶ 49].87 This data came from the Vaccine Adverse
Event Reporting System (VAERS)—anecdotal data that, while important to analyze,
requires further investigation before drawing conclusions. See, e.g., Rider v. Sandoz Pharm.
Corp., 295 F.3d 1194, 1199 (11th Cir. 2002) (“case reports alone ordinarily cannot prove
causation”); Glastetter v. Novartis Pharms. Corp., 252 F.3d 986, 989-90 (8th Cir. 2001)
(“causal attribution based on case studies must be regarded with caution”).88 Still, on June
24, 2021, a CDC safety panel reported a “likely association” in young adults from mRNA
COVID-19 vaccines and myocarditis and pericarditis, though it emphasized that it
remained rare and typically mild, with the benefits of the vaccine still outweighing the
risks [Ex. 117 ¶ 51].89 This assessment of heart inflammation’s rarity and the overarching
benefits of the vaccines has a bench of current medical support on this record,90 again
See FDA, Vaccines and Related Biological Products Advisory Committee June 10, 2021 Meeting Presentation,
https://www.fda.gov/media/150054/download#page=17 (last visited July 16, 2021).
See also CDC, The Vaccine Adverse Event Reporting System (VAERS) Results (July 17, 2021),
(“While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if
a vaccine caused or contributed to an adverse event or illness.”).
See Advisory Board, CDC Panel Reports ‘Likely Association’ of Heart Inflammation and mRNA COVID-19
Vaccines in Young People (June 24, 2021), https://www.advisory.com/daily-briefing/2021/06/24/heartinflammation.
See also Saif A. Mouch et al., Myocarditis Following COVID-19 mRNA Vaccination, 39 Vaccine 3790, 3793
(May 28, 2021), https://pubmed.ncbi.nlm.nih.gov/34092429/ (noting “mild” myocarditis and only
“possible”—not probable—connection to vaccination, and concluding that the “individual and public
benefit from COVID-19 vaccination outweighs these rare findings”); accord Carolyn M. Rosner et al.,
Myocarditis Temporally Associated with COVID-19 Vaccination, Circulation (June 16, 2021) (manuscript only),
https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.121.055891 (“[N]o data are available
specific to vaccine-associated myocarditis. The clinical course of vaccine-associated myocarditis-like illness
appears favorable, with resolution of symptoms in all patients. Given the potential morbidity of COVID19 infection even in younger adults, the risk-benefit decision for vaccination remains highly favorable.”);
Mayme Marshall et al., Symptomatic Acute Myocarditis in Seven Adolescents Following Pfizer-BioNTech COVID19
summarizes a series of US cases of myocarditis and myopericarditis following the Pfizer-BioNTech COVID19 mRNA vaccine in adolescent males . . . . At present, there is no definite causal relationship between these
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giving Indiana University a rational connection between its mandate and its aim of
campus health. This proves no less true when contracting COVID-19 (without the
vaccine) already presents a risk of myocarditis [Ex. 319 ¶ 5]. No one should blithely
dismiss the call for further investigation, but the students’ case isn’t strong today.
The students argue the temporal association of these risks, but just because the
rooster crows doesn’t mean he caused the sun to rise. A close review of Dr. McCullough’s
testimony reveals a true failing. Even he, the students’ own tendered expert, a
credentialed and board-certified physician in internal medicine and cardiovascular
disease, stops short of declaring a causative link between any vaccine and myocarditis.
He uses soft and inconsequential language, calling his suspicion “possible” and
“unpredictable” [Ex. 117 ¶ 48, 73], not probable or causative to a reasonable degree of
medical certainty. See Harris v. Owens-Corning Fiberglas Corp., 102 F.3d 1429, 1433 (7th Cir.
1996) (“mere possibility of . . . causation is not enough”). He says he has examined collegeage patients with myocarditis after a vaccine injection [Ex. 117 ¶ 59], but once again never
testifies that one was caused by the other. See Ervin v. Johnson & Johnson, Inc., 492 F.3d
901, 904–05 (7th Cir. 2007) (“mere existence of a temporal relationship between taking a
medication and the onset of symptoms does not show a sufficient causal relationship”).
cases and vaccine administration. . . . The benefits of vaccination significantly exceed possible risks.”);
Elisabeth Albert et al., Myocarditis Following COVID-19 Vaccination, 16(8) Radiology Case Reports 2142, 2144
(May 2021) (case report) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8130498/ (University of
Massachusetts researchers found “small risk” of myocarditis, and concluded that “there is a significantly
higher risk of cardiac involvement from COVID-19 infection compared to COVID-19 vaccination” such that
“vaccination should remain the cornerstone for population immunity”).
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With ever evolving COVID-19 science, more will be known tomorrow, next
month, and next year; but a courtroom is no place for guesswork today, even if wellinspired. See Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 590 (1993); Rosen v. CibaGeigy Corp., 78 F.3d 316, 319 (7th Cir. 1996); Constructora Mi Casita v. NIBCO, Inc., 448 F.
Supp.3d 965, 970-71 (N.D. Ind. 2020). Dr. Beeler testifies that “there is no proof of
causation between the vaccination and myocarditis” [Ex. 115 ¶ 69]. The court gives Dr.
McCullough’s testimony little weight on this record.91 These statements are made with
considered humility. The court isn’t deciding causation today to be sure. At the same
time, the students haven’t marshaled strong evidence that would call into legitimate
question the reasonableness of the university’s actions, or to meet their burden of an
extraordinary remedy of a preliminary injunction.
The students return to VAERS to discuss the risk of death from the vaccines. Dr.
McCullough says VAERS reported 6,136 deaths after vaccines as of June 18, 2021 [Ex. 117
¶ 45]. He says VAERS received more adult death reports from COVID-19 vaccines than
all other vaccines combined [id.]. The students offer an interim abstract from clinically
For additional examples, Dr. McCullough cites one article that “speculate[s] that adverse reaction against
the COVID-19 vaccine was responsible for the development of myocarditis due to its temporal relationship.”
Tommaso D’Angelo et al., Myocarditis after SARS-CoV-2 Vaccination: A Vaccine-induced Reaction?, Can. J.
Cardio. (June 9, 2021), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8187737/ (last visited July 17,
2021) (emphases added). Even then, the authors say “substantial evidences other than temporal aspects
still need to be provided to demonstrate the causality[.]” Id. Dr. McCullough also cites a Reuters article
concerning an Israeli study, rather than the study itself, when the Reuters article appears to overstate the
study. For instance, the article refers to 275 cases, but those cases included both COVID-19 exposures and
vaccinations. Only 148 cases occurred after vaccination. Even so, the study’s authors conclude merely that
there is “some probability for a possible link between the second vaccine dose and the onset of myocarditis
among young men aged 16 to 30,” not a probable link. Israeli Ministry of Health, Surveillance of Myocarditis
(Inflammation of the Heart Muscle) Cases Between December 2020 and May 2021 (Feb. 6, 2021),
https://www.gov.il/en/departments/news/01062021-03 (emphasis added).
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trained reviewers that considered the VAERS data as of April 2021, who grouped the
reports as those where the vaccine was most likely not a factor, where it may have been,
and where it was the most likely factor [Ex. 254].92 Of the 250 deaths reported at the time,
the reviewers concluded that 13 deaths were most likely caused by vaccines, noting that
these individuals had strong reactions soon after vaccination and died the same day or
during the next couple days [id.], though again temporal anecdotes like these aren’t as
telling. See Ervin, 492 F.3d at 904–05. They warrant further investigation to be sure; but in
close review this interim abstract offers no scientific or medical basis for drawing its
conclusion. Indeed, when the court asked counsel at oral argument what the basis was
for it, he too could offer no explanation [Tr. 34-37]. And more to the point, Dr.
McCullough again stops short of testifying that any one reported death in VAERS was
caused by a vaccine, despite this interim abstract [Ex. 117 at 21-26]. The students thus
haven’t presented evidence today demonstrating Indiana University’s decision was
irrational in pursuing its goal of campus health.
The CDC has explored this issue as well and seems to have marshaled data, at this
time, that any risk of death is rarer than the risk of death from a young adult COVID-19
infection. According to the CDC, 25,038,458 individuals aged 18-29 have been given their
first dose of the vaccine as of July 18, 2021, with VAERS reporting a total of 68 deaths, or
See Scott McLachlan et al., Analysis of COVID-19 Vaccine Death Reports from the Vaccine Adverse Events
erim_Results_and_Analysis. Dr. Beeler calls this a “reliable study looking at an unreliable system” based
on passive reports unvalidated by studies and unconfirmed data [Ex. 128 at 124-25].
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approximately 0.00027 percent, if in fact any are related.93 Alternatively, of the 6,174,415
cases of COVID-19 in this age group, 2,732 died, or approximately a 0.04 percent.94 In
balancing the risks,95 Indiana University wasn’t irrational in favoring the route that
promoted greater safety for its students.
The experts disagree over the relative risk of asymptomatic transmission (and
indeed over many scientific conclusions), with the students contending that transmission
from asymptomatic infections is “trivial and inconsequential” [Ex. 117 ¶ 26-27],96 and the
university pointing to its own experience and national trends indicating that
asymptomatic transmission is “certainly still very possible” [Ex. 115 ¶ 52].97 As with any
See CDC, The Vaccine Adverse Event Reporting System, https://wonder.cdc.gov/vaers.html (data contains
reports processed as of July 9, 2021); CDC, COVID-19 Vaccination Demographics in the United States, National,
(last visited July 14, 2021).
CDC, Demographic Trends of COVID-19 Cases and Deaths in the U.S. Reported to CDC,
https://covid.cdc.gov/covid-data-tracker/#demographics (last visited July 18, 2021).
The rate of community spread of COVID-19 in the counties in which the university’s campuses are based
is classified as “moderate” to “high” by the CDC. CDC, COVID Data Tracker: COVID-19 Integrated County
View, https://covid.cdc.gov/covid-data-tracker/#county-view (last visited July 18, 2021).
Zachary Madewell et al., Household Transmission of SARS-CoV-2: A Systematic Review and Meta-analysis,
3(12) JAMA Network Open e2031756 (Dec. 14, 2020) (Universities of Florida and Washington researchers
conclude the rate of transmission from asymptomatic and presymptomatic carriers in a household is 0.7
percent, but acknowledge finding was based on a small sample size, did not differentiate between
asymptomatic and presymptomatic carries, and that significant questions remain about infectiousness)
See Michael A. Johansson et al., SARS-CoV-2 Transmission from People Without COVID-19 Symptoms, 4(1)
JAMA Network Open e2035057 (Jan. 7, 2021) (CDC Office of Deputy Directory for Infectious Disease
researchers’ disease model suggests that transmission from asymptomatic individuals account for 24% of
all transmissions) https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2774707; Jennifer K.
Bender et al., Analysis of Asymptomatic and Presymptomatic Transmission in SARS-CoV-2 Outbreak, Germany,
2020, 27(4) Emerg. Infect. Dis. 1159 (April 2021) (European Centre for Disease Prevention & Control and
Robert Koch Institute reviewed seven asymptomatic and 46 symptomatic cases and concluded little to no
transmission from asymptomatic cases and 75 percent from presymptomatic cases)
https://wwwnc.cdc.gov/eid/article/27/4/20-4576_article; see also See Sten H. Vermund & Virginia E.
Pitzer, Asymptomatic Transmission and the Infection Fatality Risk for COVID-19: Implications for School
Reopening, 72(9) Clin. Infect. Dis. 1493-96 (May 1, 2021) (Yale researchers conclude that asymptomatic
transmission “likely represents a
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new pathogen, scientific understandings of the character and risks of transmission are
ever evolving, but a review of the balance of the current peer-reviewed research and other
literature presented by the parties suggest that asymptomatic transmission, while less
prevalent than symptomatic transmission, routinely occurs. Naturally, this conclusion
may change as scientists continue to study the virus and population transmission events.
Other risks exist or may become known. For instance, the FDA warns of the
potential for blood clots, reported the most in females ages 18-49, but calls this risk
“remote.”32 Just four days ago, the FDA added a warning to its fact sheet for the Janssen
COVID-19 vaccine that Guillain-Barré syndrome (a neurological disorder in which the
body’s immune system damages nerve cells and causes muscle weakness and sometimes
paralysis) has occurred in some people who have received the vaccine. The FDA calls this
risk “very low.”98 In contrast, Dr. Beeler testifies that brain damage proves a risk from
COVID-19 without a vaccine [Ex. 319 ¶ 5], as do several neurological diagnoses,
particularly for those hospitalized by a COVID-19 infection.99 The risks aren’t all one-
https://pubmed.ncbi.nlm.nih.gov/32584967/; Diana Buitrago-Garcia et al., Occurrence and Transmission
Potential of Asymptomatic and Presymptomatic SARS-CoV-2 Infections: A Living Systematic Review and Metaanalysis, 17(9) PLoS Med e1003346 (Sept. 22, 2020) (University of Bern and World Health Organization
researchers conclude risk of infection from an asymptomatic individuals exists but is decreased 65 percent
98 See FDA, Fact Sheet for Recipients and Caregivers Emergency Use Authorization (EUA) of the Janssen COVID19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) in Individuals 18 Years of Age and Older (July 18,
See, e.g., Maxime Taquet et al., 6-Month Neurological and Psychiatric Outcomes in 236,379 Survivors of
COVID-19: A Retrospective Cohort Study Using Electronic Health Records, 8 Lancet Psychiatry 416-27
(published online April 6, 2021), https://www.thelancet.com/journals/lanpsy/article/PIIS22150366(21)00084-5/fulltext (though calling for more data, concluding that the “severity of COVID-19 had a
clear effect on subsequent neurological diagnoses”). In fairness, this same study said whether COVID-19
was associated with Guillain-Barré syndrome “remains unclear.”
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sided, but the wealth of data and studies on which Indiana University has relied makes
the likelihood that the students will prevail on their claim here quite low.
Don’t forget that vaccines generally aren’t without medical risks. In 1993, the
Indiana General Assembly required that all public university students receive
vaccinations for five conditions, see Ind. Code § 20-12-71-11, which it later amended in
2007 to add one more, see Ind. Code § 21-40-5-2. Today that required list covers
diphtheria, tetanus, measles, mumps, rubella, and meningococcal disease. Early
diphtheria vaccines began in the 1920s, with more recent vaccines being developed in the
2000s. Tetanus vaccines were introduced in the late 1940s. The first measles vaccine was
developed in 1963, with the MMR vaccine licensed for use in 1971. The MMRV vaccine
(which protects against measles, mumps, rubella, and varicella) was licensed in 2005 per
the CDC. The first meningitis vaccine was licensed in 1974 in the United States, but more
modern vaccines were licensed in 2005, 2012, and then 2015. Risks of these vaccines are
varied, including more minor issues of fever or headache to more serious concerns of
seizure or death, though frequently low risks.
To be sure, EUA of the COVID-19 vaccines occurred on a tighter timetable and has
existed only since December 2020 and February 2021. The students thus voice concerns
about the experimental nature of the vaccines, though their counsel assures that their suit
will persist even if the FDA grants the vaccine manufacturers full approval. Not all EUAs
are equal, and the one required for COVID-19 vaccines was more robust than usual.
For an EUA to issue, the U.S. Department of Health and Human Services (HHS)
must first conclude that the biological threat identified in the emergency declaration “can
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cause a serious or life-threatening disease or condition[.]” 21 U.S.C. § 360bbb-3(c)(1).
Additionally HHS must conclude, “based on the totality of scientific evidence available
to the Secretary, including data from adequate and well-controlled clinical trials, if
available, it is reasonable to believe” the new product is effective in diagnosing, treating,
or preventing the disease and “the known and potential benefits of the product . . .
outweigh the known and potential risks of the product, taking into consideration the
material threat posed” by the public health emergency. 21 U.S.C. § 360bbb-3(c)(2).
Further, there must be “no adequate, approved, and available alternative to the product”
and the product must comport with “other criteria as the Secretary may by regulation
prescribe.” 21 U.S.C. § 360bbb-3(c)(3)-(4).
In addition to these criteria, HHS must ensure medical providers are informed of
the product’s EUA status, the “significant known and potential benefits and risks of the .
. . product, and of the extent to which such benefits and risks are unknown,” and the
availability, risks, and benefits of alternative products. 21 U.S.C. § 360bbb-3(e)(1)(A)(i)(I)(III). HHS must ensure that individuals who receive the product are informed of the
product’s EUA status, the “significant known and potential benefits and risks of such use,
and of the extent to which such benefits and risks are unknown,” and “of the option to
accept or refuse administration of the product, of the consequences, if any, of refusing
administration of the product, and of the alternatives to the product that are available
and of their benefits and risks.” 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(I)-(III). For these reasons,
those who go to get these vaccines receive fact sheets from the FDA.
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The impetus behind issuing an EUA, as opposed to going through the process for
full FDA approval, comes from the urgency required. The standard process for vaccine
approval requires a manufacturer to demonstrate compliance with statutory, regulatory,
and agency standards. See 42 U.S.C. § 262(j); 21 U.S.C. § 355(b)(1)(A); 21 C.F.R. §§ 601.2(a),
600.3(n), (p). Among other things, a manufacturer must conduct various studies,
including clinical trials, to prove that the vaccine is safe for use and is effective. 21 U.S.C.
§ 355(b)(1)(A)(i); 21 C.F.R. § 600.3(s). These trials must be complete before an application
can be submitted; indeed for COVID-19, the FDA requires manufacturers to collect and
include any data from severe adverse events for six months after the trials conclude.100
Though this process is designed to ensure safe vaccines for public use, it can take an
average of ten years to go from a mere idea to an approved vaccine.101 This can occur
more quickly too; indeed, just two days ago, the FDA granted priority review of one
vaccine, reportedly meaning that full approval from the FDA could come as soon as early
On the other hand, as opposed to waiting until clinical trials conclude, an EUA
allows a manufacturer to apply using interim clinical trial data, and the data need only
21 U.S.C. § 355(b)(1)(A)(i); 21 C.F.R. § 601.2(a), (e); § 601.20(a); see also FDA, Development and Licensure of
Vaccines to Prevent COVID-19: Guidance for Industry (June 2020); FDA, Vaccine Development 101,
https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/vaccinedevelopment-101 (last visited July 13, 2021).
See Mark M. Struck, Vaccine R&D Success Rates and Development Times, 14 Nature Biotech. 591, 592 (1996),
See BioNTech, U.S. FDA Grants Priority Review for the Biologics License Application for Pfizer-BioNTech
COVID-19 Vaccine (July 16, 2021), https://investors.biontech.de/news-releases/news-release-details/usfda-grants-priority-review-biologics-license-application.
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demonstrate the product “may be effective” and the known and potential benefits
outweigh the known and potential risks.103 Additionally, distribution and testing can
occur simultaneously.104 Although at first blush, the efficiency of an EUA may seem to
risk the greater surety of safety and efficacy, the statute anticipates the FDA will impose
additional obligations beyond those enumerated. See 21 U.S.C. § 360bbb-3(e)(1)(B).
In October 2020, the FDA released industry guidance detailing the benchmark
criteria for a COVID-19 vaccine to receive an EUA.105 Though not legally binding,106 the
industry guidance acknowledged that a COVID-19 vaccine was a “complex biological
product . . . intended to be administered to millions of individuals, including healthy
people, to prevent disease . . . [and has] the potential for broad use under an EUA.”107
Because the virus would only be overcome through the sweeping immunity of the
American public, the FDA informed manufacturers that approval would be given to
21 U.S.C. § 360bbb-3(c)(2)(A); FDA, Emergency Use Authorization for Vaccines Explained,
https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccinesexplained (last visited July 12, 2021).
Compare 21 C.F.R. § 601.21 (products under development cannot be shipped for the purpose of
introduction into commerce), with 21 U.S.C. § 360bbb-3(e)(1)(B)(i) (allowing discretion for the agency to
work with manufactures on distribution issues); see also FDA, Emergency Use Authorization of Medical
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-useauthorization-medical-products-and-related-authorities#preparedness (last visited July 12, 2021).
105 FDA, Emergency Use Authorization for Vaccines to Prevent COVID-19: Guidance for Industry (October 2020),
An industry guidance does not have the force of law, as it does not go through the rulemaking process.
However, an industry guidance informs a manufacturer of the criteria the FDA would consider sufficient
to receive approval pursuant to their statutory authority. See, e.g., FDA, Rules, Regulations and Guidance,
https://www.fda.gov/tobacco-products/products-guidance-regulations/rules-regulations-andguidance (last visited July 18, 2021) (describing industry guidance as informing the tobacco industry of
“pathways to legally market new tobacco products”).
FDA, Emergency Use Authorization for Vaccines to Prevent COVID-19: Guidance for Industry at 2.
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those EUA applications that went beyond the safety and efficacy requirements prescribed
by statute, and also expected manufacturers to consult with the FDA on the various nonclinical components of vaccine development and distribution as the clinical trial
progressed.108 The FDA wanted the same level of efficacy data as for full approval,
enough safety data to justify providing the vaccine to healthy individuals, and
confirmation of the technical procedures and verification steps necessary to support full
Thus, manufacturers were expected to submit “adequate manufacturing
information to ensure its quality and consistency” as well as “data from at least one welldesigned Phase 3 clinical trial that demonstrates the vaccine’s safety and efficacy in a
clear and compelling manner”—a heightened bar from the “may be effective” standard
prescribed by statute—while still allowing the manufacturers to complete their trials for
full authorization.43 The FDA “strongly encourage[d]” manufacturers to provide interim
data and analyses before applications were submitted, and noted that requirements
described were “essential to ensure that clinical development of a COVID-19 vaccine has
progressed far enough that issuance of an EUA for the vaccine would not interfere with
the ability of an ongoing Phase 3 trial to demonstrate effectiveness of the vaccine to
support licensure and to continue safety assessments[.]”43
See FDA, Emergency Use Authorization for Vaccines to Prevent COVID-19: Guidance for Industry 6-7, 9
(October 2020); 21 U.S.C. § 360bbb-3(c).
109 FDA, Emergency Use Authorization for Vaccines to Prevent COVID-19: Guidance for Industry 4, 9 (October
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Although the FDA directs manufacturers to present evidence of efficacy that meet
the standards necessary to receive full approval,43 a key distinction between EUA and
full approval remains. To receive full approval for a COVID-19 vaccine, a manufacturer
must monitor and submit evidence of “serious and other medically attended adverse
events in all study participants for at least 6 months after completion of all study
vaccinations.”110 However, for an EUA, the manufacturer may submit its safety data
based on a median two-months follow-up for every individual who completed the
vaccine regimen.111 The FDA concluded that a “2-month median follow-up (meaning that
at least half of vaccine recipients in clinical trials have at least 2 months of follow-up) after
completion of the full vaccination regimen will allow identification of potential adverse
events that were not apparent in the immediate postvaccination period and will also
provide greater confidence in their absence, if none are observed.”112 Based on its
experience with vaccine studies and approvals, the FDA concluded that “adverse events
considered plausibly linked to vaccination generally start within 6 weeks after vaccine
receipt,” regardless of the type of vaccine received, and thus the median two-month
follow-up was justified “by extensive historical experience with adverse events after
vaccination, the need for a vaccine to address the current pandemic, and the magnitude
of vaccine effectiveness that will be required to support a favorable benefit–risk profile
FDA, Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry 15 (June 2020).
Emergency Use Authorization for Vaccines to Prevent COVID-19: Guidance for Industry 10 (October 2020).
Philip R. Krause & Marion Gruber, Emergency Use Authorization of Covid Vaccines—Safety and Efficacy
Follow-up Considerations, 383 N. Engl. J. Med. e107(2) (Nov. 5, 2020). Dr. Marion Gruber is the director and
Dr. Phillip Krause is the deputy director of the Office of Vaccines Research and Review at the FDA.
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for use of a Covid-19 vaccine under an EUA.”111 Thus, in setting these stringent
expectations, the FDA invited EUA applications only for vaccines positioned well to
receive full approval.113
The statute grants the agency flexibility to impose additional requirements
necessary to meet the safety and efficacy concerns despite the urgency of a public health
emergency. The agency understood that a vaccine designed to be given to hundreds of
millions of Americans, healthy and otherwise, required significant safety and efficacy
data for approval. The consequences of skimping on these steps, or even adhering to the
statutory-minimum requirement of potential effectiveness, was too great; so the FDA
directed manufacturers to present evidence of efficacy that led to standards necessary to
receive full approval. And true, though the safety follow-up necessary to receive an EUA
is much shorter than would otherwise be required, the FDA made this conclusion based
on its expert assessment and experience that significant latent negative outcomes
associated with vaccinations traditionally occur within six weeks of receipt.114
Indiana University closely considered the FDA’s EUA requirements when
adopting its policy. The specialists on the university restart committee appreciated that
The industry guidance has since been superseded twice, once in February 2021 and once in May 2021.
FDA, Emergency Use Authorization for Vaccines to Prevent COVID-19: Guidance for Industry (May 2021). Pfizer,
Moderna, and Johnson & Johnson’s applications were submitted in accordance with the October 2020
guidance, see FDA, Emergency Use Authorization (EUA) for an Unapproved Product Review Memorandum
(Pfizer-BioNTech) (2020) (application submitted November 20, 2020); FDA, Emergency Use Authorization
(EUA) for an Unapproved Product Review Memorandum (Moderna) (2020) (application submitted November
30, 2020); FDA, Emergency Use Authorization (EUA) for an Unapproved Product Review Memorandum (Janssen)
(2021) (application submitted February 4, 2021).
Philip R. Krause & Marion Gruber, Emergency Use Authorization of Covid Vaccines—Safety and Efficacy
Follow-up Considerations, 383 N. Engl. J. Med. e107 (Nov. 5, 2020).
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all three COVID-19 vaccines had been “studied in robust multi-centered, international,
randomized-controlled trials and proven both effective and safe in millions of people”
[Ex. 115 ¶ 60; see also Ex. 115 ¶ 24, 61-69]. These specialists explained that the EUA
vaccines had been based on technology that has been studied for decades [id. ¶ 87].
Though even “small differences in chemical structure can sometimes make very large
differences in the type of toxic response that is produced,” McClain v. Metabolife Intern,
Inc., 401 F.3d 1233, 1246 (11th Cir. 2005); accord Glastetter, 252 F.3d at 990, much like the
FDA, the university concluded that campus safety reasonably outweighed any lingering
risks with the vaccines. This wasn’t just any ordinary EUA process, but EUA on
proverbial steroids. The university reasonably concluded that the “benefit dwarfs the
potential rare risks” [Ex. 115 ¶ 87].
Progress has been made because of the vaccine, not despite it. To the extent that
lingering medical and scientific debate remain on this record, the court remains resolved
that Indiana University has acted reasonably here in pursuing public health and safety
for its campus communities [cf. Exs. 115, 116].115 See Gonzales, 550 U.S. at 163 (state
For instance, Dr. McCullough says the vaccine manufacturers “skipped testing” for genotoxity,
mutagenicity, teratogen[i]city, and oncogenicity” [Ex. 117 ¶ 36]. Dr. Beeler explains that this claim,
including the suspicion about mutagenesis, takes a “backwards view of how RNA works in the cell and
[is] not currently supported by consensus opinion” [Ex. 115 ¶ 64]. Concerns about the impact of a vaccine
on fertility are largely addressed by the policy because Indiana University allows exemptions for pregnant
women [Ex. 115 ¶ 86]. Naturally, truly measuring the impact of any intervention, or disease for that matter,
on overall fertility to any degree of certainty requires longitudinal and perhaps even generational studies.
Even under the FDA’s full approval requirements for a COVID-19 vaccine, a manufacturer is not required
to submit data on the long-term impact on overall fertility in the population to receive approval. FDA,
Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry 7 (June 2020). Instead, the
agency recommends conditioning the enrollment of pregnant women and “women of childbearing
potential who are not avoiding pregnancy” in a clinical trial on the completion of Developmental and
Reproductive Toxicology (DART) studies. FDA, Development and Licensure of Vaccines to Prevent COVID-19:
Guidance for Industry 7, 11 (June 2020). A similar recommendation appears in the EUA guidance. Emergency
Use Authorization for Vaccines to Prevent COVID-19: Guidance for Industry 9 (October 2020). Though DART
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legislatures have “wide discretion to pass legislation in areas where there is medical and
scientific uncertainty”); Zucht, 260 U.S. at 176 (“municipality may vest in its officials
broad discretion in matters affecting the application and enforcement of a health law”).
Today, Indiana University has a rational basis to conclude that the COVID-19
vaccine is safe and efficacious for its students. The vaccine has been used on about 157
million Americans; and data now about eight months later, though it will grow more
robust in years to come, is considerable and shows major side effects are rare. Much like
over 500 universities and colleges in the United States that have done the same,116 Indiana
studies review many components of fertility and pregnancy in animal models, FDA, S5(R3) Detection of
Reproductive and Developmental Toxicity for Human Pharmaceuticals Guidance for Industry (May 2021), the
application of these studies to the approval or a COVID-19 vaccine relate to the testing, marketing, and use
of vaccines in pregnant women and in women who could imminently become pregnant, see FDA,
Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry 7, 11 (June 2020); Emergency
Use Authorization for Vaccines to Prevent COVID-19: Guidance for Industry 9 (October 2020). And though
DART studies in animals certainly shed light on greater concerns about fertility and are important, full
vaccine approval is not conditioned on fertility studies in women or men. See id. Instead, the impact of a
vaccine on pregnancy and pregnancy outcomes in women is a vital post-approval safety assessment. see
FDA, Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry 17 (June 2020).
Moderna and Johnson & Johnson submitted DART studies as part of their EUA applications. Both
manufacturers identified no fertility or development concerns based on these studies. FDA, Vaccines and
Related Biological Products Advisory Committee December 17, 2020 Meeting Presentation—Emergency Use
Authorization (EUA) Application for mRNA-1273 (Dec. 17, 2020); Janssen Biotech, Inc, Vaccines and Related
Biological Products Advisory Committee Meeting February 26, 2021 (Feb. 26, 2021). Pfizer submitted DART
results after its EUA was granted. The studies showed the vaccine did not impact female fertility or
development, albeit in rats. Christopher J. Bowman et al., Lack of Effects on Female Fertility and Prenatal and
Postnatal Offspring Development in Rats with BNT162b2, a mRNA-based COVID-19 Vaccine, 103 Reproductive
Toxicology 28 (Aug. 2021).
Andy Thomason and Brian O’Leary, Here’s a List of Colleges That Will Require Students or Employees to Be
Vaccinated Against Covid-19, The Chronicle of Higher Education (July 15, 2021),
https://www.chronicle.com/blogs/live-coronavirus-updates/heres-a-list-of-colleges-that-will-requirestudents-to-be-vaccinated-against-covid-19?cid2=gen_login_refresh (“The Chronicle has so far identified
583 such campuses.”). Generally, courts “should not invade the domain of local authority except when it
is necessary to do so” to enforce fundamental rights. Jacobson, 197 U.S. at 38. In addition to the Fourteenth
Amendment’s protections, a wide variety of states have enacted legislation relating to vaccine mandates or
vaccine documentation, including Ohio just this last week. See 2021 Bill Text OH H.B. 244, Sec. 3792.04(B)(1)
(signed into law on July 14, 2021); cf., e.g., Ark. Code Ann. § 20-7-142 (prohibiting vaccine mandate); Fla.
Stat. § 381.00316 (prohibiting governmental entities from requiring COVID-19 vaccination documentation
and prohibiting educational institutions from requiring that students provide COVID-19 vaccination
documentation); 2021 Bill Text CA A.B. 327 (proposed) (bill that would prohibit entities from requiring
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University reasonably relies on the vaccine as a measure to return to normal school
functioning. The students say the mandate is unreasonable because no other Indiana
government agency mandates the vaccine. But just because it has gone above what others
have done doesn’t make it unreasonable. Indeed, universities are unique places, with lots
of people gathered and living together in close quarters for months at a time. That Indiana
University’s mandate goes beyond what other public universities in Indiana have done
doesn’t compel a finding that this policy is unreasonable; indeed, other universities in the
state have mandated the vaccine, and many others around the country have too.
Indiana University is following the recommendations of other well-established
agencies, including the Centers for Disease Control, U.S. Department of Education, and
the Indiana State Department of Health. These are reliable sources to assess the
reasonableness of measures implemented, though the court must be cautious not to
expand the guidance beyond what it says. See United States v. Newton, 996 F.3d 485, 489
(7th Cir. 2021); Mays v. Dart, 974 F.3d 810, 823 (7th Cir. 2020), cert. filed. To be sure, the
CDC doesn’t recommend that schools “mandate” the vaccine—a point the students
make—but such a recommendation isn’t consistent with the CDC’s purview, which is to
act as an informative agency. At the same time, the university’s policy isn’t inconsistent
with the CDC’s recommendations. The CDC says institutions of higher learning “can
return to full capacity in-person learning, without requiring or recommending masking
or physical distancing for people who are fully vaccinated” [Ex. 116 ¶ 12]. The CDC’s
COVID-19 vaccination documentation). The court will not overstep into the legislative sphere when the
state’s or state arm’s conduct has complied with the Constitution.
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guidance to universities is that “[v]accination is the leading prevention strategy to protect
individual from COVID-19 disease and end the COVID-19 pandemic.”117 This will
enhance the student body’s opportunities, allowing them to have a more fulfilling college
Vaccination helps the university get to herd immunity. As its expert, Dr. Beeler,
has said, COVID-19 vaccination is an important tool to help stop the pandemic because
widespread vaccination will help achieve “herd immunity,” which is when enough
people in a community are sufficiently protected from COVID-19 to stem its spread [Ex.
115 ¶ 19-20].118 To be sure, experts debate whether herd immunity is achievable for
COVID-19 [Ex. 115 ¶ 21], but Indiana University rationally believes vaccination is the
leading prevention strategy to protect individuals from COVID-19 disease. According to
Dr. Beeler, “Indiana has not reached herd immunity” [Ex. 115 ¶ 43; see also Exs. 128 at 60,
129 at 23]. As Dr. Beeler explains, “immunity is not static with this virus, and things do
change specifically as it relates to variants of concern. . . . The longer that the coronavirus
remains in the population, each vulnerable individual that gets infected is the
opportunity for further mutations in the virus. And eventually, just by evolutionary
theory, the virus will develop ways to bypass the current immune stress” [Ex. 128 at 61].
The mutability of COVID-19 remains higher than other conditions addressed by a single
CDC, Guidance for Institutions of Higher Education (IHEs) (last updated June 4, 2021),
See CDC, COVID-19 Vaccines Are Free to the Public (last visited June 27, 2021),
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/no-cost.html; CDC, Key Things to Know about
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vaccine, like measles, mumps, and rubella [id. at 151-52]. With the variants of concern
affecting recent numbers, and based on Dr. Beeler’s well-reasoned explanation, the court
tends not to credit Dr. McCullough’s viewpoint that herd immunity has already been
Overall, the students’ arguments amount to disputes over the most reliable
science. But when reasonable minds can differ as to the best course of action—for
instance, addressing symptomatic versus asymptomatic virus spread or any number of
issues here—the court doesn’t intervene so long as the university’s process is rational in
trying to achieve public health. See, e.g., Phillips, 775 F.3d at 542 (“plaintiffs argue that a
growing body of scientific evidence demonstrates that vaccines cause more harm to
society than good, but as Jacobson made clear, that is a determination for the
[policymaker], not the individual objectors”). There is a rational basis for making
distinctions here. No student, including those not yet exempt, have shown that Indiana
University’s vaccine mandate as applied to them violates rational basis review. The court
thus denies their request to enjoin it preliminarily.
On This Preliminary Record, Exempt Students Haven’t Shown a
Likelihood of Success on their Claim that Indiana University Lacks a
Rational Basis for Its Vaccine Policy, Including Additional Requirements.
Six students are exempt from the vaccination mandate but challenge the additional
measures of mask wearing, testing, and social distancing: Ryan Klaassen (Ex. 100 ¶ 18081), Jaime Carini (¶ 182-95), Macey Policka (¶ 207-08), Daniel Baumgartner (¶ 196-200),
Ashlee Morris (¶ 201-04), and Seth Crowder (¶ 205-06). Collectively, they argue that these
requirements, oft-used over the last year, infringe on their bodily autonomy, medical
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privacy, religious beliefs, and essentially become a “scarlet letter” targeting them for
bullying and scorn from their peers for their medical conditions or religious beliefs.119
Indiana University first challenges this argument on a procedural ground. It says
these students failed to challenge its masking or testing policies in their complaint. They
cite to the well-known legal principle that “a plaintiff is the master of her own complaint,”
and that courts shouldn’t read unalleged assertions into a complaint. Thornley v. Clearview
AI, Inc., 984 F.3d 1241, 1246 (7th Cir. 2021); see also Caterpillar, Inc. v. Williams, 482 U.S. 386,
398-99 (1987). The complaint isn’t so narrowly pleaded. It gives fair notice that the
students are challenging the vaccine mandate and the policy’s additional requirements.
See Fed. R. Civ. P. 8(a)(2); Bell Atl. Corp. v Twombly, 550 U.S. 544, 555 (2007).
Indiana University’s vaccine mandate is multifaceted. It requires all students,
faculty, and staff to receive a COVID-19 vaccine and report their vaccination status, or to
obtain an exemption and comply with the additional requirements. The university lumps
the various parts of this mandate under a general “COVID-19 vaccine requirement”
umbrella. For instance, on Indiana University’s “frequently asked questions” page about
its COVID-19 vaccination requirement, the section provides that vaccinations are
required, the deadlines for such vaccinations, the need for students to report vaccination
status, the exempted categories, and the additional requirements imposed on exempted
students, along with the consequences for failing to get a vaccine [Ex. 118 at 3-6].
The scarlet letter is a literary reference to a mark that identifies one as belonging to a certain group in a
scornful or ostracizing way. See Nathaniel Hawthorne, The Scarlet Letter (1850).
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Because the students challenge the additional requirements under substantive due
process, the court again begins by first examining the specific right they assert. See Doe,
377 F.3d at 768. These students argue that they have rights to refrain from wearing a mask
and to refuse nasal testing. But there is no fundamental constitutional right to not wear a
mask. Kelly v. ImagineIF Library Entity, 2021 U.S. Dist. LEXIS 111958, 8 (D. Mont. June 15,
2021); Whitfield v. Cuyahoga Cnty. Pub. Library Found., 2021 U.S. Dist. LEXIS 92944, 4 (N.D.
Ohio May 17, 2021); Denis v. Ige, __ F. Supp.3d __, 2021 U.S. Dist. LEXIS 91037, 14 (D.
Haw. May 12, 2021); W.S. by Sonderman v. Ragsdale, __ F. Supp.3d __, 2021 U.S. Dist. LEXIS
98185, 5 (N.D. Ga. May 12, 2021); Forbes v. City of San Diego, 2021 U.S. Dist. LEXIS 41687,
11 (S.D. Cal. Mar. 4, 2021); Stewart v. Justice, __ F. Supp.3d __, 2021 U.S. Dist. LEXIS 24664,
20 (S.D. W. Va. Feb. 9, 2021); Oakes v. Collier Cnty., 2021 U.S. Dist. LEXIS 15174, 4 (M.D.
Fla. Jan. 27, 2021); Shelton v. City of Springfield, 497 F. Supp.3d 408, 414 (W.D. Miss. 2020);
see also Ryan v. Cnty. of DuPage, 45 F.3d 1090, 1092 (7th Cir. 1995) (no constitutional right
to wear a mask); United States v. Berglund, 2021 U.S. Dist. LEXIS 78476, 2 (D. Minn. Apr.
23, 2021) (“Courts have repeatedly found that requiring participants at trial to wear face
masks due to the COVID-19 pandemic does not violate a criminal defendant’s
constitutional rights.”).120 Nor is there a fundamental constitutional right to not be tested
for a virus before entering a place of public accommodation. Aviles v. De Blasio, 2021 U.S.
Dist. LEXIS 38930, 50 (S.D.N.Y. Mar. 2, 2021); see also Webb v. Johnson, 2021 U.S. Dist. LEXIS
Plaintiffs cite to a recent Florida state court decision which held, based on its state constitution, that the
right to privacy applies to a mask-wearing mandate, triggering strict scrutiny. See Green v. Alachua Cnty.,
2021 Fla. App. LEXIS 8634 (Fla. Dist. Ct. App. June 11, 2021). But as this case makes clear, it is based on
Florida’s state constitution, not the federal constitution. It is thus inapposite here.
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95392, 13 (D. Neb. Mar. 2, 2021) (D. Neb. May 19, 2021) (prisoner had no fundamental
right to refuse having his temperature taken); Wilcox v. Lancour, 2021 U.S. Dist. LEXIS
11968, 23-24 (W.D. Mich. Jan. 22, 2021) (prisoner had no fundamental right to refuse a
nasal passage test for COVID-19); Little Rock Family Planning Servs. v. Rutledge, 458 F.
Supp.3d 1065, 1074 (E.D. Ark. 2020) (applying Jacobson to uphold requirement that
women obtain negative COVID-19 test before medical procedure).
The court declines the students’ invitation to expand substantive due process
rights to include the rights not to wear a mask or to be tested for a virus. These aren’t
rights so “deeply rooted in this Nation’s history and tradition” and so “implicit in the
concept of ordered liberty” such that “neither liberty nor justice would exist if they were
sacrificed.” Washington v. Glucksberg, 521 U.S. 702, 721 (1997) (quotation omitted); Khan v.
Bland, 630 F.3d 519, 535 (7th Cir. 2010). These aren’t issues of fundamental constitution
import, but often transient and trivial inconveniences.
But wait, certain students say: mask wearing and testing violates their religion.
The First Amendment says “Congress shall make no law . . . prohibiting the free exercise”
of religion. U.S. Const. amend. I. The right to exercise religion is fundamental. See
Cantwell v. Connecticut, 310 U.S. 296, 303 (1940). As a fundamental right, it would trigger
strict scrutiny, but the Supreme Court has held that general regulations that have the
effect of incidentally burdening religious practices in general and neutral ways need only
be rationally supported by the state. “[T]he right of free exercise does not relieve an
individual of the obligation to comply with a valid and neutral law of general
applicability on the ground that the law proscribes (or prescribes) conduct that his
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religion prescribes (or proscribes).” Smith, 494 U.S. at 879 (quotation omitted); accord Ill.
Bible Colleges Ass’n v. Anderson, 870 F.3d 631, 639 (7th Cir. 2017).
Indiana University’s extra requirements fit within the neutral and generally
applicable laws protected by Smith. The vaccine mandate contains an early reference to
religion by way of exemption; but this isn’t used to burden religion, but instead gives
those of religious conviction the benefit of freely practicing their religious conviction to
refuse the vaccine. See Listecki v. Official Comm. of Unsecured Creditors, 780 F.3d 731, 744
(7th Cir. 2015) (“A benefit to religion does not disfavor religion in violation of the Free
Exercise Clause.”); see also Smith, 494 U.S. at 888 (Scalia, J.) (no exemption required). The
students who received the religious exemption are subject to the same extra requirements
as those who receive the medical exemption.
One may well applaud the university for going beyond what the constitution
requires: courts have consistently held that schools that provided a religious exemption
from mandatory vaccination requirements did so above and beyond that mandated by the
Constitution. See Nikolao, 875 F.3d at 316; Phillips, 775 F.3d at 543; Workman, 419 F. Appx.
at 356; Whitlow, 203 F. Supp.3d at 1084; Boone, 217 F. Supp.2d at 954. What the students
request now is a religious exemption from the religious exemption, but Indiana
University has no obligation to provide this. See Smith, 494 U.S. at 879.
On this record, the court finds no merit in the students’ contention that wearing
masks essentially labels them with a “scarlet letter” that targets them for religious
bullying. Indiana University has both medical and religious exemptions, and the same
requirements are imposed on both groups. There is no evidence that any exempted
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person must reveal publicly which exemption they obtained. Wearing masks thus doesn’t
signify to others that the individual religiously objects to the vaccination; they could fall
within either exempted category, or they could be a vaccinated individual who chooses
to take the extra (and unrequired) precaution to wear a mask. A student wearing a mask
may well just be precautious in light of COVID-19 variants or because of
immunosuppressing conditions. This record is devoid of any evidence of bullying or
To be sure, there are some unique circumstances when wearing a mask could
negatively impact the student’s educational experience. For example, Jaime Carini is
pursuing doctorates in organ performance and literature and musicology and, to
complete her graduate program, she must perform at organ recitals [Ex. 121 at 22, 27].
She believes performing these recitals while masked will have an impact on her
performance as an organist, who use their whole bodies to perform [id. 90]. Similarly,
Macey Policka is pursuing a degree in theater with an emphasis on acting, and she says
the mask requirement is “devastating” to her education [Ex. 125 at 41]. She says wearing
a mask has a huge impact on how she can interact with other actors and will put her at a
distinct disadvantage to other student actors who don’t have to wear masks [id.]. Though
the court sympathizes with these concerns, these are matters for the university reasonably
to address, not matters of constitutional import.
The students once more assert another alleged right—this time the right to the
confidentiality of their medical information—to obtain strict scrutiny. But this circuit has
never recognized one’s constitutional right to privacy to medical information. Franklin v.
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McCaughtry, 110 F. Appx. 715, 719 (7th Cir. 2004); Rowe v. Wexford of Ind., 2021 U.S. Dist.
LEXIS 31766, 3-4 (N.D. Ind. Feb. 22, 2021). This right may exist by statute, but isn’t found
in the Constitution. And this circuit recognized that such a right, if any, is minimized
when in the public context. See Franklin, 110 F. Appx. at 719 (describing hospital
emergency rooms, doctor’s offices, and school infirmaries). The court declines finding
such a fundamental right in the context here.
That said, the court applies rational basis review for the extra requirements of
masks and testing for the exempted students. Indiana University has a legitimate interest
in promoting the health and safety of its students. And the masks and testing are
rationally related to achieving those measures. This is true for several reasons.
First, both vaccinated and unvaccinated people can still get the virus. Though
health experts differ on the efficacy of masks in preventing the spread of COVID-19, such
a dispute is left to the resolution of the policymakers, particularly when studies have
shown universal mask wearing resulted in decreases in COVID rates than populations
that forewent masks [Ex. 128 at 108]. And social distancing continues to be recommended
by the CDC and health experts as effective at eliminating the spread of the disease.121 The
students offer no sound evidence that social distancing isn’t effective.
Second, the CDC says schools should account for students, faculty, and staff who
aren’t vaccinated.122 And it has continued to recommend masks and social distancing for
CDC, How to Protect Yourself & Others, https://www.cdc.gov/coronavirus/2019-ncov/prevent-gettingsick/prevention.html (updated June 11, 2021).
CDC, Guidance for Institutions of Higher Education (IHEs), https://www.cdc.gov/coronavirus/2019ncov/community/colleges-universities/considerations.html#section1 (updated June 4, 2021).
USDC IN/ND case 1:21-cv-00238-DRL-SLC document 34 filed 07/18/21 page 90 of 101
these individuals.122 This is consistent with what Indiana University has already done for
a semester as well.
Third, even students who feel fine and don’t have a fever may still have the virus
as an asymptomatic individual, so the heightened precautions as to them continue to be
rational.123 Despite the low mortality rates, young adults can still transmit the virus to
others [Ex. 115 ¶ 10-11]. For those with milder or even asymptomatic cases, as is more
prevalent in this age group, the risk of inadvertent transmission grows [Ex. 115 ¶ 53-55].
Fourth, these measures are reasonable in scope. The testing methods are
reasonable for the circumstances: they plan to use a rather non-intrusive saliva test. See
Banks v. United States, 490 F.3d 1178, 1189 (10th Cir. 2007) (“saliva tests impose minimal
intrusions”); Padgett v. Ferrero, 294 F. Supp.2d 1338, 1342 (N.D. Ga. 2003) (“bodily
intrusion of taking . . . saliva sample is minimal”); see also Wilson v. Collins, 517 F.3d 421,
428 (6th Cir. 2008) (saliva sample is less intrusive than blood drawing). Though this form
of testing may be less reliable than nasal testing, it is significantly less intrusive—and
given that the students’ assert their right to bodily autonomy, this is a good thing. Though
it may present some inconvenience for the students by taking time away from their
studies, this impact is minimal and within the sound discretion of the school.
Fifth, students have lived with mask mandates for over a year now, so it is nothing
that is unreasonable, at least not when the risk still exists. These students have worn
See, e.g., Sten H. Vermund & Virginia E. Pitzer, Asymptomatic Transmission and the Infection Fatality Risk
for COVID-19: Implications for School Reopening, 72(9) Clin. Infect. Dis. 1493-96 (May 1, 2021) (Yale
researchers conclude that asymptomatic transmission “likely represents a substantial proportion of total
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masks at school, stores, work, church, and even at a casino. In other contexts, the
government has lawfully mandated wearing protective gear, like a mask, when it also
provides benefits to the public—like mandated bicycle helmets, hair nets, ear plugs, and
any number of personal protective equipment. See, e.g., Burr v. Atty. Gen. Delaware, 641 F.
Appx. 194, 196 (3d Cir. 2016) (per curiam) (seatbelt mandate held constitutional); Picou v.
Gillum, 874 F.2d 1519, 1519 (11th Cir. 1989) (Powell, J.) (state statute requiring motorcycle
riders to wear protective headgear was constitutional). It is no less reasonable here.
Irreparable Harm & Adequate Remedy at Law.
Irreparable harm is “harm that cannot be repaired and for which money
compensation is inadequate.” Orr, 953 F.3d at 502 (quoting Graham v. Med. Mut. of Ohio,
130 F.3d 293, 296 (7th Cir. 1997)) (quotations omitted). To the extent that the students
establish a constitutional harm, the law presumes irreparable harm. See, e.g., Cuomo, 141
S. Ct. at 67-68 (First Amendment free exercise of religion); Elrod v. Burns, 427 U.S. 347, 373
(1976) (First Amendment political association); Christian Legal Society v. Walker, 453 F.3d
853, 859 (7th Cir. 2006) (“loss of First Amendment freedoms is presumed to constitute an
irreparable injury”); Ezell v. City of Chicago, 651 F.3d 684, 699 (7th Cir. 2011) (Second
Amendment); Preston v. Thompson, 589 F.2d 300, 303 n.3 (7th Cir. 1978) (“The existence of
a continuing constitutional violation constitutes proof of an irreparable harm.”); Doe v.
Mundy, 514 F.2d 1179, 1183 (7th Cir. 1975) (right to privacy); Democratic Nat. Committee v.
Bostelmann, 447 F. Supp.3d 757, 769 (W.D. Wis. 2020); Planned Parenthood of Ind. v.
Commissioner, 194 F. Supp.3d 818, 835 (S.D. Ind. 2016) (presuming equal protection and
substantive due process harms irreparable); 11A Wright & Miller, Federal Practice &
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Procedure § 2948.1 (2d ed. 1995) (“When an alleged deprivation of a constitutional right
is involved . . . most courts hold that no further showing of irreparable injury is
necessary.”). That remains true only with the vaccine mandate.
That doesn’t mean every alleged harm in this case is irreparable. A delay in
collegiate or graduate education isn’t typically irreparable harm. See, e.g., Phillips v. Marsh,
687 F.2d 620, 622 (2d Cir. 1982); Hodges v. Bd. of Supervisors, 2020 U.S. Dist. LEXIS 153949,
7 (E.D. La. Aug. 25, 2020); Pierre v. University of Dayton, 143 F. Supp.3d 703, 714 (S.D. Ohio
2015) (“[C]ourts have also held that a suspension is not irreparable.”); Baer v. Nat’l Bd. of
Med. Examiners, 392 F. Supp.2d 42, 49 (D. Mass. 2005) (inability to continue as medical
student without interruption is not a harm that is irreparable to potential medical career).
Each exempted student testified that he or she wore masks on many occasions
during the pandemic.124 Any concerns about the hypothetical segregation or
discrimination are only speculative and don’t constitute irreparable harm. See Duthie v.
Matria Healthcare, Inc., 543 F. Supp.2d 958, 960 (N.D. Ill. 2008). Several students have been
tested for COVID-19 multiple times with no irreparable harm. And though a few students
cite concerns about the safety of nasal testing swabs, Indiana University’s testing uses
saliva. Though some students say the extra requirements are unnecessary or
inconvenient, neither concern rises to the level of irreparable harm. See, e.g., Students v.
United States Dep’t of Education, 2016 U.S. Dist. LEXIS 150011, 125 (N.D. Ill. Oct. 18, 2016);
Right Field Rooftops, LLC v. Chicago Baseball Holdings, LLC, 87 F. Supp.3d 874, 895 (N.D. Ill.
See Ex. 120 at 27 (Ryan Klaassen); Ex. 121 at 44 (Jaime Carini); Ex. 122 at 19-20 (Danial Baumgartner); Ex.
123 at 35-36 (Ashlee Morris); Ex. 124 at 22 (Seth Crowder); Ex. 125 at 17 (Macey Policka); Ex. 126 at 31
(Margaret Roth); Ex. 127 at 29-32 (Natalie Sperazza).
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2015) (“inconvenience does not show that harm would be irreparable); Lewis v. Silverman,
2005 U.S. Dist. LEXIS 20347, 6-7 (N.D. Ind. Sept. 16, 2005).
Wearing masks, undergoing surveillance testing, and social distancing also aren’t
indicative of irreparable harm, but consistent with CDC guidelines [Ex. 129 at 28]. See
Orr, 953 F.3d at 502 (defining irreparable harm). For these particular circumstances, the
students also have an adequate remedy at law—money damages. The presumption that
money is never an adequate remedy for constitutional violation is wrong. See Campbell v.
Miller, 373 F.3d 834, 835 (7th Cir. 2004). Such damages would be normal and adequate to
address what, even in the most severe light, to be no more than a personal injury. See id.
To be inadequate, a remedy needn’t be “wholly ineffectual,” but it must be
“seriously deficient as compared to the harm suffered.” Foodcomm Intern. v. Barry, 328
F.3d 300, 304 (7th Cir. 2003). If there were to be a constitutional injury here, the court
could see that there is no adequate remedy at law if it didn’t issue the preliminary
injunction. That is less potent when the likelihood of success is so low. See Adams v. City
of Chicago, 135 F.3d 1150, 1154 (7th Cir. 1998) (if court finds neither irreparable harm nor
a likelihood of success, the “analysis ends and the preliminary injunction should not be
issued”); Dish Network LLC v. Cox Media Grp., LLC, 2020 U.S. Dist. LEXIS 126850, 20 (N.D.
Ill. July 20, 2020) (plaintiff’s “failure to demonstrate a reasonable likelihood of success on
the merits alone is enough to deny its motion”); Geneva Intern. Corp. v. Petrof, SPOL,
S.R.O., 529 F. Supp.2d 932, 940 (N.D. Ill. 2007) (“Because [plaintiff] fails to demonstrate
irreparable harm, we need not continue to analyze the remaining factors.”).
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In short, the court presumes the students could establish irreparable harm and the
absence of an adequate remedy at law, except as noted here.
The Balance of the Harms and Public Interest Favor Indiana University.
The balance of harms against the parties and the public interest favor denying the
preliminary injunction. This is a sliding scale analysis. The court “weighs the balance of
potential harms” against “the movant’s likelihood of success.” Turnell, 796 F.3d at 662.
The more likely the plaintiff is to win, the less the balance of harms needs to favor them;
the less likely, the more it must weigh in their favor. Id. The court has already said the
students’ likelihood of success is low, and the odds favor the university.
To be sure, the students have a significant liberty interest in refusing unwanted
medical treatment. Telling them they must take unwanted medical treatment is a
significant intrusion on their liberty. And under the harm principle, “the only purpose
for which power can be rightfully exercised over any member of a civilized community,
against his will, is to prevent harm to others.” John Stuart Mill, On Liberty 9 (1859); see
Cassell, 990 F.3d at 550. If the students’ decision to refuse the vaccine affected themselves
alone, the balance of harms would almost certainly weigh in favor of granting a
But the evidence reasonably shows that they aren’t the only ones harmed by
refusing to get vaccinated: refusing while also not complying with heightened safety
precautions could “sicken and even kill many others who did not consent to that tradeoff.” Cassell, 990 F.3d at 550. This certainly impacts the public interest: the students “are
not asking to be allowed to make a self-contained choice to risk only their own health” in
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making this decision—their decision necessarily bears on the health of other students,
faculty, and staff. Id. The balance of harms doesn’t weigh in the students’ favor here.
And because the students aren’t being forced to take the vaccine against their will,
the harm is demonstrably less. Though the students may have to forego a semester of
school or transfer somewhere else—certainly a difficult and inconvenient choice, and not
one lightly tossed aside—they have options. Other colleges in Indiana and around the
nation haven’t mandated vaccines. Indiana University says it will reassess the mandate
after this semester. This mandate will also enhance the academic environment for all
students, faculty, and staff by fostering in-person education and a more traditional
college experience, educationally and socially. Today, based on this record, the balance
of harms tilts heavily in favor of the university.
The public interest also favors denying a preliminary injunction. The court isn’t a
policymaker: that role is left to the States. On multiple occasions, the Supreme Court has
“recognized the role of the States as laboratories for devising solutions to difficult legal
problems.” Arizona State Legislature v. Arizona Independent Redistricting Commission, 576
U.S. 787, 817 (2015) (quoting Oregon v. Ice, 555 U.S. 160, 171 (2009)); United States v. Lopez,
514 U.S. 549, 581 (1995) (Kennedy, J., concurring) (“States may perform their role as
laboratories for experimentation to devise various solutions where the best solution is far
from clear”); New State Ice Co. v. Liebmann, 285 U.S. 262, 311 (1932) (Brandeis, J.,
dissenting) (“It is one of the happy incidents of the federal system that a single
courageous state may, if its citizens choose, serve as a laboratory; and try novel social and
economic experiments without risk to the rest of the country.”). Enabling the this state
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university to work through these problems reasonably fosters public health and safety in
areas of scientific uncertainty. See Gonzales, 550 U.S. at 163 (citing Jacobson, 197 U.S. at 3031) (the law gives “wide discretion to pass legislation in areas where there is medical and
scientific uncertainty”); Cassell, 990 F.3d at 549 (“scientific uncertainty surrounding the
pandemic further cautions against enjoining state coronavirus responses unless
absolutely necessary”); see also Cuomo, 141 S. Ct. at 68 (“Members of this Court are not
public health experts”).
To be sure, if the students had shown a likelihood that the university was
unreasonably infringing on their constitutional rights, enjoining that violation would be
in the public interest. See Joelner v. Village of Washington Park, 378 F.3d 613, 620 (7th Cir.
2004) (“upholding constitutional rights serves the public interest”) (quoting Newsom v.
Albermarle Cnty. Sch. Bd., 354 F.3d 249, 261 (4th Cir. 2003)); Ind. Fine Wine & Spirits, LLC v.
Cook, 459 F. Supp.3d 1157, 1171 (S.D. Ind. 2020) (same). But this concern doesn’t apply
here because the students have a low likelihood of success.
In short, the balance of harms and the public interest favor Indiana University and
the determination that it has reasonably determined the best course of action for the
health of its academic community this upcoming fall semester. And in doing so, Indiana
University plans to return sooner to normal operations—thus serving much more than
just its academic community.
What This Opinion Isn’t.
Don’t misread it. The court is not declaring the absolute safety and efficacy of the
vaccines, or for all people. People need to understand the risks, remain informed as the
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science evolves, monitor the review before the FDA, and determine whether to take a
vaccine. The court must decide this case on the evidence before it. The evidence today
shows that the students have little chance of success: Indiana University is reasonably
pursuing a legitimate aim of public health for its students, faculty, and staff.
This university policy isn’t forced vaccination. The students have options—taking
the vaccine, applying for a religious exemption, applying for a medical exemption,
applying for a medical deferral, taking a semester off, or attending another university.
This policy applies for the fall 2021 semester only. Students may make their choice after
being advised of the risks and benefits of the vaccines, thereby giving informed consent.
The court recognizes that for certain students this may prove a difficult choice, but a
choice nonetheless. The choice isn’t so coercive as to constitute irreparable constitutional
harm. Although it proves a condition to attend this fall, it is reasonable under the
This isn’t a decision after a final trial on the merits. The court has made this
decision based on evidence, testimony, and briefing that the parties produced on an
emergent timetable. They and their skilled counsel should be commended for the quality
of their submissions, particularly under tight demands. But not every stone has been
unturned by the parties. Not every study has been hashed out or submitted for the court
to read. Not every witness has testified. Although constituting more than 100 exhibits
and testimony from many individuals, including proposed experts, much of which then
refers the court to innumerable studies and articles that it has endeavored to review
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carefully, much in these five days, this still is a preliminary record, with an opinion issued
urgently given the interests of these parties.
The court also isn’t saying Indiana University (or any other State or state entity)
may do whatever it wants to address COVID-19. Given the liberty at stake for these
students here, the university must act reasonably in achieving a legitimate state goal of
public health. The Fourteenth Amendment’s due process clause checks that authority.
Today’s decision doesn’t provide carte blanche authority for Indiana University to do as it
pleases without regard to the Constitution. For instance, in the future, the goal of seeing
zero or very low new positive cases as a rolling average in attainment of herd immunity
may or may not prove reasonable [see Ex. 242 at 62-63], but those aren’t the circumstances
now facing the university, and those aren’t the circumstances now presented to the court.
Speculative concerns about hypothetical future events don’t show irreparable harm.
Duthie v. Matria Healthcare, Inc., 543 F. Supp.2d 958, 960 (N.D. Ill. 2008).
The policy will no doubt evolve. The court questioned the parties about the scope
of the university’s medical exemption. The university’s standard vaccination policy,
originating from the General Assembly’s mandate that public university students receive
certain vaccinations, contains an exemption for medical contraindications,125 with
support from a physician’s statement [Ex. 229]. Whereas, curiously, the university’s
COVID-19 policy preserves medical exemptions only for allergies to vaccine ingredients,
A contraindication is any “condition in a recipient that increases the risk for a serious adverse reaction.”
CDC, General Best Practice Guidelines for Immunization: Best Practices Guidance of the Advisory Committee on
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not contraindications—ostensibly a narrower basis for exemption for an EUA vaccine
than for other decades-existing vaccines.
At oral argument, Indiana University explained that, at the time of adoption,
allergies proved the only contraindication and that the university has applied its medical
exemption more broadly. There is some evidence for this in the record [see, e.g., Ex. 128 at
84-88]. Four physicians on the university medical team consider any requested medical
exemption and work with the student’s physician to address any immunocompromising
condition (and, at times, try to educate the physician on certain pathophysiologies that
aren’t of concern) [id.]. In doing so, the university follows CDC guidance. The university
thus has considered for exemption such conditions as vaccine-suppressing medications,
pregnancy, steroids, chemotherapy, and organ transplants, to name a few [id. at 85-88].
In truth, the medical exemption has been applied more broadly than it is written.
Wisdom might counsel its update to reflect reality and an evolving science.
Jumping on this concern, the students call the medical exemption arbitrary in oral
argument. The record doesn’t bear this out. Indeed, no matter the seeming problematic
nature of a narrow medical exemption as written, it has been reasonably broad as applied
[id.]. The simple truth is that none of the eight students here have sought a medical
exemption with the support of a physician’s statement to trigger this issue.
Jaime Carini says she wanted a medical exemption, but she never sought one; and
she has a religious exemption that she secured in any event [Ex. 121 at 58-60, 69; Tr. 53].
She doesn’t present facts that show the university chose to ignore a doctor’s
recommendation. Margaret Roth has legitimate concerns about taking the vaccine, but
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she too hasn’t applied for a medical exemption or been denied [Ex. 126 at 26]. Natalie
Sperazza believes it unsafe, but she too provides no physician’s statement to support this
view or shows she applied for a medical exemption [Ex. 127 at 64]. A future case might
raise an issue under the medical exemption, but that’s not today’s case. See Jacobson, 197
U.S. at 36-37 (leaving option to challenge vaccine mandate for contraindications). The
court won’t issue an advisory opinion. See Brixen, 908 F.3d at 280.
Even assuming in certain respects irreparable harm and an inadequate remedy at
law, the students here haven’t established a likelihood of success on the merits of their
Fourteenth Amendment due process claim, or that the balance of harms or the public’s
interest favors the extraordinary remedy of a preliminary injunction, before a trial on the
merits. The court thus DENIES their preliminary injunction motion [ECF 7].
Recognizing the significant liberty interest the students retain to refuse unwanted
medical treatment, the Fourteenth Amendment permits Indiana University to pursue a
reasonable and due process of vaccination in the legitimate interest of public health for
its students, faculty, and staff. Today, on this preliminary record, the university has done
so for its campus communities. That leaves the students with multiple choices, not just
One might well hale a certain Emersonian self-reliance and self-determination as
preference—an unfettered right of the individual to choose the vaccine or not—but, given
a preliminary record such as today’s, the court must exercise judicial restraint in
superimposing any personal view in the guise of constitutional interpretation.
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Reasonable social policy is for the state legislatures and its authorized arms, and for the
People to demand through their representatives.
July 18, 2021
s/ Damon R. Leichty
Judge, United States District Court
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