Dr. T. et al v. McKee

Filing 22

MEMORANDUM AND ORDER Re: 2 Motion for Preliminary Injunction. So Ordered by District Judge Mary S. McElroy on 1/7/2022. (Potter, Carrie) (Main Document 22 replaced on 1/7/2022) (Potter, Carrie).

Case 1:21-cv-00387-MSM-LDA Document 22 Filed 01/07/22 Page 1 of 25 PageID #: 525

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF RHODE ISLAND
DR. T., NURSE T., HOSP. CLERK
M., DR. J., and HEALTH UNIT
COORDINATOR L., CUSTODIAN S.,
TECHNICIAN H., AND NURSE R.
Plaintiffs,
v.
NICOLE ALEXANDER-SCOTT, in
her official capacity as Director of the
Rhode Island Department of Health,
and DANIEL J. MCKEE in his official
capacity as Governor of the State of
Rhode Island,
Defendants.

)
)
)
)
)
)
)
)
) C.A. No. 1:21-cv-00387-MSM-LDA
)
)
)
)
)
)
)
)

MEMORANDUM AND ORDER
Mary S. McElroy, United States District Judge.
I.

INTRODUCTION

The Court now considers the plaintiffs’ Motion for a Preliminary Injunction
(ECF No. 2) on an expanded record, having previously denied their request for a
temporary restraining order.
The plaintiffs, all health care workers, seek injunctive relief against the
enforcement of Rhode Island Department of Health (“RIDOH”) Emergency
Regulation 216-RICR-20-15-8, (“Regulation”) promulgated August 17, 2021, which
requires all healthcare workers, except those meeting a very narrow medical
exception, to be vaccinated against COVID-19 by October 1, 2021. The plaintiffs

1

Case 1:21-cv-00387-MSM-LDA Document 22 Filed 01/07/22 Page 2 of 25 PageID #: 526

claim that, because this Regulation does not include an opportunity for a healthcare
worker to obtain a religious exemption to vaccination, it violates the United States
Constitution and Title VII of the Civil Rights Act of 1964.
The plaintiffs ask the Court to enjoin the RIDOH from enforcing any
requirement that employers deny religious exemptions from COVID-19 vaccination
or that they revoke any exemptions employers already granted before the Regulation;
that the RIDOH be barred from interfering with the granting of religious exemptions
going forward; and from taking any disciplinary action against the plaintiffs for
seeking or having obtained a religious exemption.
For the following reasons, the Court DENIES the plaintiffs’ Motion.
II.

BACKGROUND

All findings of facts are based upon the affidavits and other exhibits provided
by the parties. The Court is aware of news reports that, in light of the rapidly
spreading Omicron variant of COVID-19 and the everchanging nature of the
pandemic, the RIDOH has issued new guidance allowing for the possibility of certain
COVID-19 positive healthcare workers to work at a healthcare facility if it is
determined that the facility is facing a crisis-level staffing shortage. No parties,
however, have sought to reopen or supplement the record since this RIDOH
announcement or to otherwise argue how it may support their position. The Court
will therefore proceed to consider the plaintiffs’ motion on the existing record, which
is as follows.
Since early 2020, the SARS-CoV-2 virus responsible for the COVID-19 disease

2

Case 1:21-cv-00387-MSM-LDA Document 22 Filed 01/07/22 Page 3 of 25 PageID #: 527

has spread across the world causing a global health emergency. At the time of the
parties’ submissions, COVID-19 and/or its variants has caused the deaths of over
2,700 Rhode Islanders; more than 650,000 Americans, and upwards of 4.4 million
people worldwide. (ECF No. 16-2, Affidavit of Dr. James McDonald (“McDonald
Affidavit”) ¶ 9. 1 At the time of this writing, those numbers have grown significantly.
In mid-December 2020, after a year of public health mitigation measures such
as social distancing, quarantining, mask wearing, the U.S. Food and Drug
Administration authorized vaccines for emergency use. Id. ¶ 22.

On January 21,

2021, about a month after the COVID-19 vaccines became available, Rhode Island
had a 7-day percent positive rate of 5.0% (which was down from 6.6% the previous
week), but its average of 201.6 daily cases per 100,000 people in the last seven days
was the second highest in the United States. Id. ¶ 29. Approximately two months
later, on March 17, 2021, Rhode Island’s seven-day percent positive rate decreased to
2.0%. Id. ¶ 30. The Director of the RIDOH, Dr. Nicole Alexander-Scott, affirms to “a
reasonable degree of medical certainty, vaccination was the primary reason for this
decrease.” (ECF No. 16-1, Affidavit of Dr. Nicole Alexander-Scott (“Alexander-Scott
Affidavit”) ¶ 29.)
On January 1, 2021, Rhode Island had 776 positive COVID-19 cases, and 452
people hospitalized with COVID-19. McDonald Affidavit ¶ 31a. By May 1, 2021,
Rhode Island had 175 positive COVID-19 cases, and 139 COVID-19 hospitalizations;

James McDonald, MD, MPH, serves as the Medical Director of the RIDOH’s COVID
Unit.

1

3

Case 1:21-cv-00387-MSM-LDA Document 22 Filed 01/07/22 Page 4 of 25 PageID #: 528

by June 1, 2021, positive COVID-19 cases dropped to 42 and hospitalizations dropped
to 47; and by July 1, 2021, COVID-19 cases decreased to 24 and hospitalizations
dropped to 23. Id. ¶ 31. But this general downward trend that Rhode Island and
much of the United States experienced during the first seven months of 2021 halted
in August. Id. ¶ 32. By August 1, 2021, the number of COVID-19 positive cases
increased to 90 and hospitalizations increased to 46; by August 15, 2021, COVID-19
positive cases climbed to 162 and hospitalizations to 102; and by August 26, 2021,
COVID-19 positive cases reach 337 and hospitalizations 127. Id. ¶ 32.
Health care services have been particularly affected. Scientific research shows
health care workers have higher rates of infection than people in other fields.
Alexander-Scott Affidavit ¶ 15. With heath care workers having higher rates of
infection, it follows that patients interacting with them have a threefold increased
risk of COVID-19, and the household members of patients interacting with health
care professionals have a twofold increased risk of COVID-19. Id. ¶ 16. As of October
11, 2021, according to the CDC, 596,027 health care personnel in the United States
have contracted COVID-19 and 1,939 have died. Id. The CDC has recommended that
all health care personnel receive the COVID-19 vaccine, since they “continue to be on
the front line of the nation’s fight against COVID-19” by “providing critical care to
those who are or might be infected with the virus that causes COVID-19.” Id. ¶ 19.
SARS-CoV-2, like other viruses, mutates over time. McDonald Affidavit ¶ 15.
These mutations change the properties of the original strain and affect the ability of
the virus to be transmitted from person to person and how virulent (or deadly) the

4

Case 1:21-cv-00387-MSM-LDA Document 22 Filed 01/07/22 Page 5 of 25 PageID #: 529

virus may be. Id. By early August 2021—the same time as the number of positive
cases and hospitalizations began to rise—SARS-CoV-2 had mutated to form what is
known as the Delta variant which has become the dominant strain in Rhode Island
and the United States. 2 Id. ¶ 17. Patients with the Delta variant may have a viral
load over 1,000 times higher than the original SARS-CoV-2 strain, meaning such
patients have over 1,000 times more copies of the virus within them as compared to
the original strain. Id. Medical and scientific journals have also reported that the
Delta variant is 6 to 8 times more contagious than the original strain, and therefore,
more likely to cause infections even in fully vaccinated individuals. Id. Notably,
however, infections are even more likely, with more serious health consequences, in
unvaccinated persons. Id.
Based on these factors and statistics, as well as the upward trend in COVID19 cases and hospitalizations, on August 17, 2021, the RIDOH promulgated the
Regulation at issue. Specifically, it required all “health care workers” and all “health
care providers” to be vaccinated against COVID-19 by October 1, 2021, except those
with a medical exemption. 216-RICR-20-15-8.
Two days later, on August 19, 2021, Governor Daniel J. McKee further
responded to the increased cases and hospitalizations caused by the Delta variant by
declaring a state of emergency. Governor Daniel J. McKee, Executive Order 21-86,
Aug. 19, 2021, available at https://governor.ri.gov/executive-orders/executive-order-

As noted above, these are the facts as they exist in the record before the Court. As
of the writing of this opinion information that is available seems to indicate that
Omicron, and not Delta, is currently the predominant variant in the United States.

2

5

Case 1:21-cv-00387-MSM-LDA Document 22 Filed 01/07/22 Page 6 of 25 PageID #: 530

21- 86. The Declaration of Disaster Emergency was punctuated by various findings,
including that hospitals’ emergency departments were exceeding capacity; that
hospitalizations and deaths have consistently increased since July 4, 2021; and that
a field hospital in Cranston would be reopened to accommodate the possible surge
caused by the Delta variant. Id.
It noteworthy that while the Regulation, 216-RICR-20-15-8, was new, the
requirement that health care workers vaccinate against known diseases preexists the
COVID-19 pandemic. In 2002, RIDOH promulgated Regulation 216-RICR-20-15-7,
entitled “Immunization, Testing, and Health Screening for Health Care Workers.”
This regulation requires evidence of immunity for health care workers for Measles,
Mumps, Rubella, Varicella (chickenpox), Tetanus, Diphtheria, Pertussis, and
Tuberculosis. Accordingly, to work as a health care worker in Rhode Island, a health
care worker must have immunity from these diseases. Like the COVID-19 vaccine,
only a medical exemption is expressed in 216-RICR-20-15-7, and like COVID-19, the
purpose of 216-RICR20-15-7 is not only to protect health care workers but also people
being treated by health care workers, and the broader community. Alexander-Scott
Affidavit ¶ 12. As such, Rhode Island has a history of requiring vaccinations for its
health care workers, without a religious exception.
In deciding to issue the Regulation, the RIDOH determined that reducing the
number of unvaccinated personnel who can expose vulnerable patients to a
potentially deadly disease in the health care setting is of utmost importance.
McDonald Affidavit ¶ 47. In the fall and winter seasons, during which the weather

6

Case 1:21-cv-00387-MSM-LDA Document 22 Filed 01/07/22 Page 7 of 25 PageID #: 531

becomes colder, and people gather indoors, the likelihood of spread of the highly
contagious Delta variant increases. Alexander-Scott Affidavit ¶ 22. Additionally, as
cold and flu season has arrived, the varying symptoms of COVID-19 (e.g., cough,
fever, fatigue, muscle or body aches, headache, sore throat, congestion or runny nose,
among others) could easily be mistaken for a cold or the flu. Id.
The RIDOH’s central goal of the Regulation is to permit only vaccinated
professionals near patients. Id. ¶ 13a. “This purpose is important because health
care facilities treat and provide care for persons who are vulnerable due to their
health conditions, some of whom themselves are unprotected by vaccination.” Id.
Importantly, “more traditional non-pharmaceutical measures intended to prevent
spread and protect patients and workers, such as masking and social distancing, may
not always be possible because of the nature of health care services provided.” Id.
Additionally, a vaccinated health care worker will have a lower viral load, making he
or she less likely to transmit COVID-19 to the patient. Id.
Another consideration: “health care workers and health care providers who are
not vaccinated are more likely to become sick with COVID-19.” Id. ¶ 13b. This would
result in a reduction of the work force necessary to provide quality care. Id.
In considering the Regulation, DOH officials also considered less restrictive
means to achieve its goals. As related by Dr. Alexander-Scott, for instance:
RIDOH also considered whether certain non-pharmaceutical measures, such
as masking and testing, would have achieved the purpose of the Regulation,
but RIDOH also rejected this alternative. Specifically, while testing might
alert a facility that it has a health care worker within its facility that is positive
for COVID-19, RIDOH’s objective is, to the greatest extent possible, to keep
COVID-19 positive persons out of health care facilities. An unvaccinated
7

Case 1:21-cv-00387-MSM-LDA Document 22 Filed 01/07/22 Page 8 of 25 PageID #: 532

person who tests positive for COVID-19 could have been within a health care
facility for days before being alerted to the positive test. During this period of
time, these persons could be spreaders of the COVID-19 virus, and this is
particularly problematic concerning the increased transmission of the Delta
variant. Wearing masks does provide some protection against the spread of
COVID-19 and RIDOH considered this alternative to vaccination, however this
alternative was rejected since vaccination is a superior alternative to masking.
This is supported by the extensive data and evidence regarding the efficacy of
vaccines. … Importantly, only vaccination—not masking or testing—provides
continued protection against contracting COVID-19 twenty-four hours a day,
seven days a week. While less than one percent of health care workers and
health care providers may be unvaccinated and wearing masks, increasing this
number would hinder the RIDOH purpose. Allowing more people to remain
unvaccinated, but wear masks, would also create enforcement issues similar
to what has been seen in society. For example, in many cases it would be
difficult if not impossible to know who is vaccinated and who is not vaccinated.
Without knowing who was vaccinated, it would be impossible to enforce a
mask-wearing requirement.
Additionally, RIDOH’s goal is to achieve herd immunity in Rhode Island. It is
estimated that herd immunity will be reached at 97% of the total population.
Currently, approximately 69% of the total Rhode Island population is
vaccinated. The only way to achieve this goal is through vaccination.
Additionally, scientific evidence and data exists that vaccination is the best
counter-measure against contracting and spreading COVID-19. For instance,
as explained in Dr. McDonald’s affidavit, during the period from January 2021
to early July 2021, the rate of positive COVID-19 cases and hospitalizations
generally declined. During much of this period of time – and for many months
before this period of time – Rhode Islanders were required to wear masks when
indoors. However, it was not until vaccinations began in mid-December 2020
that Rhode Island began to see a significant decrease in the number of positive
cases and hospitalizations. While this decrease may have been affected by
many variables, based upon my review of the studies and data, it is my opinion
to a reasonable degree of medical certainty, that this decrease was primarily
due to vaccination. Dr. McDonald’s affidavit references other studies
supporting the conclusion that vaccination is the most effective measure to
prevent the spread and contraction of COVID-19. See McDonald Affidavit ¶¶
22, 23. Even when the indoor mask requirement was lifted in May 2021,
positive cases and hospitalizations continued to decrease until the Delta
variant became the dominant strain in Rhode Island in July 2021. See
McDonald Affidavit ¶ 28. To a reasonable degree of medical certainty,
vaccination was the primary reason for this decrease.
Alexander-Scott Affidavit, ¶ 28-29.

8

Case 1:21-cv-00387-MSM-LDA Document 22 Filed 01/07/22 Page 9 of 25 PageID #: 533

The RIDOH considered, too, that studies have demonstrated that previous
COVID-19 infection has not shown to be as effective at preventing the disease than
vaccination. Id. ¶ 22.
The only exception from the vaccine requirement expressed in the Regulation
is a defined medical exemption. Medically exempt individuals must comply with
certain masking and testing requirements set forth in the Regulation. Importantly,
the medical exemption itself is narrow, stating:
[a] health care worker or health care provider shall be medically exempt from
being required to be vaccinated provided that a licensed physician, physician
assistant or advanced practice registered nurse signs a medical exemption
stating that the health care worker or health care provider is exempt from the
COVID-19 vaccine because of medical reasons in accordance with Advisory
Committee on Immunization Practices (ACIP) guidelines and determined as
acceptable by the facility.
The Regulation’s medical exemption does not allow a person to claim any medical
exemption they see fit, but rather is limited to only five enumerated medical
contraindications, which must be verified by a medical provider. The first four are
consistent with manufacturer warnings, the last, is consistent with Centers for
Disease Control guidance.
The five medical contraindications available are:
1. Severe allergic reaction (e.g., anaphylaxis) after previous dose or to a
component of the vaccine;
2. Immediate allergic reaction of any severity after a previous dose or known
(diagnosed) allergy to a component of the vaccine;
3. History of myocarditis or pericarditis after a first does of an mRNA COVID-

9

Case 1:21-cv-00387-MSM-LDA Document 22 Filed 01/07/22 Page 10 of 25 PageID #: 534

19 vaccine;
4. History of myocarditis or pericarditis unrelated to mRNA COVID-19
vaccination; and
5. Monoclonal Antibody Treatment (MABS) within the 90 days prior to October
1, 2021 (healthcare worker should get vaccinated no later than 91 to 120 days after
MABS).
Each of these medical contraindications lasts only as long as the medical
conditions exists and the fifth medical contraindication sunset on December 30, 2021.
Thereafter, only four medical contraindications are available. See Alexander-Scott
Affidavit ¶ 5 (“In order to ensure that an many health care workers and health care
providers as possible are vaccinated, the ‘medical exemption’ is limited only to the
enumerated contraindications and extends only to those in whom the vaccine poses a
serious threat to their own health, including the risk of death, as determined by a
medical provider.”).
At the time of briefing in this matter, with 81% of health care facilities
reporting, out of the 61,016 health care workers RIDOH is aware of, 57,757 have been
vaccinated and 365 are subject to a medical exemption. Id. That is, only 0.59% of
health care workers have a valid medical exemption. Id. ¶ 8.
Dr. Alexander-Scott explains the RIDOH reasoning for including only a limited
medical exemption:
“Allowing exemptions other than the limited medical exemption permitted,
would defeat RIDOH’s purpose in promulgating the Regulation, which is to
ensure as best as possible the continued health and well-being of health care
workers and health care providers, as well as those treated by health care
10

Case 1:21-cv-00387-MSM-LDA Document 22 Filed 01/07/22 Page 11 of 25 PageID #: 535

workers and health care providers, as the COVID-19 pandemic continues.”
Alexander-Scott Affidavit ¶ 9.
RIDOH’s goal of achieving herd immunity also would also be set-back. Id. ¶ 28.
While the Regulation contains no other exemptions, Dr. Alexander-Scott states
that it “is not intended to bar employers from considering requests from employees
who religious or other accommodations, and employers who receive a religious
exemption request should act in conformity with applicable state and federal law.”

Id. ¶ 14. Unvaccinated health care workers without a medical exemption, however,
are not allowed to enter a health care facility. Id. But “RIDOH would expect the
employer to … consider alternative work-conditions, such as telemedicine….” Id.
The plaintiffs provided a November 3, 2021, Notice of Violation and
Compliance Order to a health care facility with some unvaccinated persons in the
facility, some claiming religious exemptions. (ECF No. 20.) In response, the health
care facility placed an employee on administrative leave because his or her job could
not be performed remotely. Id.
III.

PRELIMINARY INJUNCTION STANDARD

“In determining whether to grant a preliminary injunction, the district court
must consider: (i) the movant’s likelihood of success on the merits of its claims; (ii)
whether and to what extent the movant will suffer irreparable harm if the injunction
is withheld; (iii) the balance of hardships as between the parties; and (iv) the effect,
if any, that an injunction (or the withholding of one) may have on the public interest.”

Corp. Techs., Inc. v. Harnett, 731 F.3d 6, 9 (1st Cir. 2013). Of these factors, “[t]he
movant’s likelihood of success on the merits weighs most heavily in the preliminary
11

Case 1:21-cv-00387-MSM-LDA Document 22 Filed 01/07/22 Page 12 of 25 PageID #: 536

injunction calculus.” Ryan v. U.S. Immigr. & Customs Enf’t, 974 F.3d 9, 18 (1st Cir.
2020). “If the moving party cannot demonstrate that he is likely to succeed in his
quest, the remaining factors become matters of idle curiosity.” Me. Educ. Ass’n

Benefits Tr. v. Cioppa, 695 F.3d 145, 152 (1st Cir. 2012). The Court should not award
the “extraordinary and drastic remedy” of a preliminary injunction unless the
plaintiffs meet their burden of persuasion with “substantial proof.” Marzurek v.

Armstrong, 520 U.S. 968, 972, 117 S. Ct. 1865, 138 L.Ed.2d 162 (1997).
IV.

DISCUSSION

Courts in this country have held for over a century that mandatory vaccination
laws are a valid exercise of a state’s police powers, and such laws have withstood
constitutional challenges. See, e.g., Employment Div., Dep’t of Human Res. Of Ore.

v. Smith, 494 U.S. 872, 889 (1990) (identifying “compulsory vaccination laws” as
among the neutral, generally applicable laws that did not require religious
exemptions under the First Amendment); Prince v. Massachusetts, 321 U.S. 158, 16667, n.12 (1944) (noting that the right to practice one’s religion freely “does not include
liberty to expose the community … to communicable disease”); Zucht v. King, 260
U.S. 174, 176-77 (1922) (holding that there was no equal protection violation where
child prohibited from attending school without vaccinations, and explaining that “in
the exercise of the police power reasonable classification may be freely applied, and
that regulation is not violative of the equal protection clause merely because it is not
all- embracing”); Jacobson v. Massachusetts, 197 U.S. 11, 25-27 (1905) (holding that
mandatory vaccination laws do not offend “any right given or secured by the

12

Case 1:21-cv-00387-MSM-LDA Document 22 Filed 01/07/22 Page 13 of 25 PageID #: 537

Constitution,” and that a state’s police power allows imposition of “restraints to which
every person is necessarily subject for the common good”). See also Does 1-6 v. Mills,
No. 1:21-cv-00242, 2021 WL 4783626, *6 n.12 (D. Me. Oct. 13, 2021) (citing, inter alia,

Phillips v. City of New York, 775 F.3d 538, 543 (2d Cir. 2015) (“[M]andatory
vaccination as a condition for admission to school does not violate the Free Exercise
Clause”); Workman v. Mingo Cnty. Bd. Of Educ., 419 Fed. App’x 348, 352-54 (4th Cir.
2011) (relying on the Jacobson, Zucht, and Prince line of cases to hold that a state
mandatory vaccination law that allowed medical but not religious exemptions was
constitutional); Whitlow v. California, 203 F. Supp. 3d 1079, 1084, 1086 (S.D. Cal.
2016) (“[I]t is clear that the Constitution does not require the provision of a religious
exemption to vaccination requirements” because, “[a]s stated in Prince, the right to
free exercise does not outweigh the State’s interest in public health and safety.”).
With this background, the Court now considers the Regulation under the
jurisprudence interpreting the Free Exercise Clause of the First Amendment to the
United States Constitution.
A. Free Exercise Clause
“The First Amendment’s Free Exercise Clause, as incorporated against the
states by the Fourteenth Amendment, protects religious liberty against government
interferences.” Does 1-6 v. Mills, 16 F.4th 20, 29 (1st Cir. 2021) (citing Cantwell v.

Connecticut, 310 U.S. 296, 303-04 (1940)). “When a religiously neutral and generally
applicable law incidentally burdens free exercise rights, we will sustain the law
against constitutional challenge if it is rationally related to a legitimate government

13

Case 1:21-cv-00387-MSM-LDA Document 22 Filed 01/07/22 Page 14 of 25 PageID #: 538

interest.” Id. (citing Fulton v. City of Philadelphia, 141 S. Ct. 1868, 1876 (2021)).
“When a law is not neutral or generally applicable, however, we may sustain it only
if it is narrowly tailored to achieve compelling governmental interest.” Id. (citing

Fulton, 141 S. Ct. at 1881).
A law is not neutral if it “single[s] out religion or religious practices” or
“restricts practices because of their religious nature.”

Id. (citing Church of the

Lukumi Babalu Aye, Inc. v. City of Hialeah, 508 U.S. 520, 532-534 (1993); Fulton,
141 S. Ct. at 1877). And “[t]o be generally applicable, a law may not selectively
burden religiously motivated conduct while exempting comparable secularly
motivated conduct.” Id. (citing Lukumi, 508 U.S. at 543). A law is not generally
applicable “if it prohibits religious conduct while permitting secular conduct that
undermines the government’s asserted interests in a similar way.” Id. (quoting

Fulton, 141 S. Ct. at 1877).
Here, the Regulation is facially neutral. It does not make express (or even
implied) reference to religious practice. Lukumi, 508 U.S. at 533 (“[T]he minimum
requirement of neutrality is that a law not discriminate on its face.”). Beyond the
Regulation’s text, however, it cannot be considered neutral if its object is to
discriminate against religious beliefs, practices, or motivations. Id. at 534. That is,
the Regulation would be violative of the Free Exercise Clause upon a demonstration
of “masked” government hostility toward religious belief. Id.
There is no evidence this is so. The object of the Regulation is to protect public
health and safety by reducing the incidence of COVID-19 and, to do so, it is required

14

Case 1:21-cv-00387-MSM-LDA Document 22 Filed 01/07/22 Page 15 of 25 PageID #: 539

that drastically limit, if not eliminate, unvaccinated persons from health care
facilities. Indeed, the neutrality of the Regulation is further demonstrated by its
narrow medical exemption. It does not allow a healthcare worker to claim any
medical exemption; rather, such exceptions are limited to five enumerated
contraindications which “would itself cause a serious medical condition as recognized
by the manufacturers of the vaccines and/or the CDC.” Alexander-Scott Affidavit ¶
9. These specific medical exemptions demonstrate that the object of the Regulation
is public health, not to discriminate against religious beliefs or practices. To require
those who may face negative medical outcomes to take the vaccine “would contravene
RIDOH’s purposes to advance and protect the health and well-being of health care
workers, if getting the vaccine would itself cause a serious medical condition as
recognized by the manufacturers of the vaccines and/or the CDC.” Id. See also

Jacobson, 197 U.S. at 39 (holding that “it would be cruel and inhuman in the last
degree” to require vaccination “if it is apparent or can be shown with reasonable
certainty that he is not at the time a fit subject of vaccination, or that vaccination, by
reason of his then condition, would seriously impair his health, or probably cause his
death”).
Indeed, the Regulation’s medical exemption is narrower than that in effect in
Maine and recently declared to be constitutional by the First Circuit. See Mills, 16
F.4th at 30.

The Maine exemption is not restricted to specific medical

contraindications consistent with vaccine manufacturer warnings or CDC guidance.
Rather, Maine law allows for a “generalized ‘medical exemption … available to an

15

Case 1:21-cv-00387-MSM-LDA Document 22 Filed 01/07/22 Page 16 of 25 PageID #: 540

employee who provides a written statement from a licensed physician, nurse
practitioner or physician assistant that, in the physician’s, nurse practitioner’s or
physician assistant’s professional judgment, immunization … may be medically
inadvisable.’” Id. (quoting Me. Rev. Stat. tit. 22, § 802(4-B)). See also Does v. Mills,
595 U.S. __, __ (2021) (Gorsuch, J., dissenting) (slip op., at 3) (criticizing Maine’s law
because it may allow for medical exemptions beyond the contraindications specific to
the COVID-19 vaccines and does not “limit what may qualify as a valid ‘medical’
reason to avoid inoculation”).
The Regulation also is generally applicable.

It applies to all healthcare

workers and does not “require the state government to exercise discretion in
evaluating individual requests for exemptions.” Mills, 16 F.4th at 30. There is
instead a specific, limited exemption based on objective criteria. See id.
Further, the Regulation “is generally applicable because it does not permit
‘secular conduct that undermines the government’s asserted interests in a similar
way.’” Id. (quoting Fulton, 141 S. Ct. at 1877; Tandon v. Newsom, 141 S. Ct. 1294,
1296 (2021)).

The Regulation’s medical exemption serves the state’s principal

purpose of protecting public health. A failure to exempt the limited number of
individuals whose health a vaccine may jeopardize would be counterproductive to
that goal to the extent of illogicality. There is no suggestion of a discriminatory bias
against religion.
The plaintiffs argue that the Regulation lacks neutrality and general
applicability because Rhode Island’s law on immunization for any public and private

16

Case 1:21-cv-00387-MSM-LDA Document 22 Filed 01/07/22 Page 17 of 25 PageID #: 541

school includes both a medical and religious exemption. See R.I.G.L. § 16-38-2. This
is unpersuasive. First, courts consistently have held that a religious exemption is not
constitutionally required for mandatory school vaccination requirements. Does 1-6

v. Mills, No. 1:21-cv-00242, 2021 WL 4783626, *6 n.12 (D. Me. Oct. 13, 2021)
(collecting cases).

Indeed, “schools that provided a religious exemption from

mandatory vaccination requirements did so above and beyond that mandated by the
Constitution.” Klaasen v. Trs. of Ind. Univ, No. 1:21-CV-238, 2021 WL 3073926, at
*17-22, *39 (N.D. Ind. July 18, 2021), aff'd, 7 F.4th 592 (7th Cir. 2021). Moreover,
whether a religious accommodation should be included in an otherwise neutral,
generally applicable regulatory law, the Supreme Court has held, is for the political
branches of government to decide and not a court upon a Free Exercise challenge.

Emp. Div., Dep’t. of Hum. Res. of Or. v. Smith, 494 U.S. 872, 890 (1990) (“[T]o say
that a nondiscriminatory religious-practice exemption is permitted, or even that it is
desirable, is not to say that it is constitutionally required, and that the appropriate
occasions for its creation can be discerned by the courts. It may fairly be said that
leaving accommodation to the political process will place at a relative disadvantage
those religious practices that are not widely engaged in; but that unavoidable
consequence of democratic government must be preferred to a system in which each
conscience is a law unto itself or in which judges weight the social importance of all
laws against the centrality of all religious beliefs.”)
Here, Rhode Island, through the political process, decided to allow an
otherwise constitutionally unrequired religious exemption to vaccine requirements in

17

Case 1:21-cv-00387-MSM-LDA Document 22 Filed 01/07/22 Page 18 of 25 PageID #: 542

schools. But the Court here is not considering schools, it is considering health care
workers. In that realm, the RIDOH has been consistent that health care worker
vaccination requirements include only a medical exemption. RIDOH’s Regulation
216-RICR-20-15-7, promulgated in 2002, requires health care worker immunization
for certain communicable diseases and includes no religious exemption. RIDOH has
made that same determination with respect to COVID-19 vaccination.

This is

consistent with RIDOH’s purpose to minimize the spread of disease for the sake of
public health. The State has presented evidence, and the Court finds, that additional
exemptions, including a broader medical exemption, would as Dr. Alexander-Scott
puts it, “defeat RIDOH’s purpose in promulgating the Regulation, which is to ensure
as best as possible the continued health and well-being of health care workers and
health care providers, as well as those treated by health care workers and health care
providers, as the COVID-19 pandemic continues.” Alexander-Scott Affidavit ¶ 9. See

also Mills, 16 F.4th at 31 (“[P]roviding healthcare workers with medically
contraindicated vaccines would threaten the health of those workers and thus
compromise both their own health and their ability to provide care.”).
The plaintiffs also argue that the Regulation runs afoul of the Supreme Court’s
holding in Tandon v. Newsom, 141 S. Ct. 1294 (2021), that a law is not neutral and
generally applicable under the Free Exercise Clause if it treats “any comparable
secular activity more favorably than religious exercise.” 141 S. Ct. 1294, 1296 (2021).
“Comparability [for free exercise purposes] is concerned with the risks various
activities pose, not the reasons why people gather.” Mills, 16 F.4th at 32 (quoting

18

Case 1:21-cv-00387-MSM-LDA Document 22 Filed 01/07/22 Page 19 of 25 PageID #: 543

Tandon, 141 S. Ct. at 1296). Because the medical exemption requires all healthcare
workers to be vaccinated unless vaccination is medically contraindicated, it furthers
the state’s public health interest. Id. A religious exemption does not address a risk
associated with the Regulation’s objectives. Holding that Maine’s vaccine mandate
did not run afoul of Tandon, the First Circuit offered an analogy: if the Regulation
“were an occupancy limit, it would apply to all indoor activities based on facility size,
but it would exempt healthcare facilities. That analogous policy would serve the
state’s goal of protecting public health, while maximizing the number of residents
able to access healthcare and thus minimizing health risks.” Id.
Because the Court finds that the Regulation is neutral and of general
applicability, rational basis review applies. “A law survives rational basis review so
long as the law is rationally related to a legitimate government interest.” Cook v.

Gates, 528 F.3d 42, 55 (1st Cir. 2008). There is no dispute that reducing the number
of unvaccinated healthcare workers who can expose vulnerable patients to a
potentially deadly disease is a legitimate government interest. See Roman Catholic

Diocese of Brooklyn v. Cuomo, 141 S. Ct. 63, 67 (2020) (holding that promoting the
public health by preventing the spread of COVID-19 is “unquestionably a compelling
interest”). The Regulation is rationally related to this interest.
For instance, the state has presented credible evidence that vaccination is the
best countermeasure against contracting and spreading COVID-19. Masking and
testing alone is insufficient compared to the continued protection of vaccine.
Unvaccinated individuals are more likely to contract and transmit COVID-19 and

19

Case 1:21-cv-00387-MSM-LDA Document 22 Filed 01/07/22 Page 20 of 25 PageID #: 544

suffer serious medical consequences.
Because rational basis review applies and the Regulation passes that test, the
Court does not to proceed analyze whether the Regulation would survive a test of
strict scrutiny. 3
B. Equal Protection
The plaintiffs also present a claim under the Equal Protection Clause of the
U.S. Constitution’s Fourteenth Amendment but “[w]hen a free exercise challenge
fails, any equal protection claims brought on the same grounds are subject only to
rational-basis review.” Mills, 16 F.4th at 35. Because the plaintiffs are unlikely to
succeed on their free exercise claims, they are unlikely to succeed on their equal
protection claims. See id.
C. The Supremacy Clause and Title VII of the Civil Rights Act of 1964
The plaintiffs’ also assert that the Regulation compels healthcare facilities to
disregard Title VII of the Civil Rights Act and thereby violates the Supremacy Clause
to the U.S. Constitution, Art. VI, cl. 2. The Supremacy Clause “is not the ‘source of
any federal rights,’ and certainly does not create a cause of action.” Armstrong v.

Exceptional Child Ctr., Inc., 575 U.S. 320, 324-25 (2015) (quoting Golden State
Transit Corp. v. Los Angeles, 493 U.S. 103, 107 (1989)). Thus, the plaintiffs claim
under the Supremacy Clause is not likely to succeed on its merits.

Nevertheless, under the First Circuit’s precedent in Mills regarding Maine’s
healthcare worker vaccine requirement, the Regulation here, too, would meet the
more exacting strict scrutiny test. See 16 F.4th at 32-35.
3

20

Case 1:21-cv-00387-MSM-LDA Document 22 Filed 01/07/22 Page 21 of 25 PageID #: 545

The plaintiffs further argue that the November 5, 2021, Center for Medicare &
Medicaid Services (“CMS”) interim final rule with comment period (“IFC”), which
mandates COVID-19 vaccines for health care providers who receive Medicare and/or
Medicaid funding, preempts the Regulation. 4 See 86 Fed. Reg. 61555 (Nov. 5, 2021).
The CMS IFC allows for both medical and religious exemptions. Specifically, the
plaintiffs point to the following language: “this IFC preempts the applicability of any
State or local law providing for exemptions to the extent such law provides broader
exemptions than provided for by Federal law and are inconsistent with this IFC.” Id.
at 61572.
The Court interprets this language as precluding a broader exemption than
the IFC, which provides that health care employers must make accommodations for
an individual seeking an exemption including religious exemptions. But, as described
in more detail below, nothing in the Regulation precludes an employer from making
an accommodation consistent with Title VII of the Civil Rights Act, provided it can
do so without an undue hardship.
Turning to the plaintiffs’ argument that Title VII itself preempts the
regulation, that statute forbids an employer “to discriminate against, any individual
because of his . . . religion.” 42 U.S.C.A. § 2000e-2(c)(1). Title VII requires that
employers “offer a reasonable accommodation to resolve a conflict between an

It is unclear if the CMS regulation applies to any these currently anonymous
plaintiffs as the record does not indicate if they all work in facilities that receive the
requisite funding.

4

21

Case 1:21-cv-00387-MSM-LDA Document 22 Filed 01/07/22 Page 22 of 25 PageID #: 546

employee’s sincerely held religious belief and a condition of employment, unless such
an accommodation would create an undue hardship for the employer’s business.”

Cloutier v. Costco Wholesale Corp., 390 F.3d 126, 133 (1st Cir. 2004).
The plaintiffs have not joined any employers to this action.

Instead, the

plaintiffs argue that the Regulation is preempted by Title VII. Federal law preempts
state law (1) where Congress “preempt[s] state law by so stating in express terms”;
(2) where “the scheme of federal regulation is sufficiently comprehensive to make the
reasonable inference that Congress ‘left no room’ for supplementary state regulation”;
and (3) only where there is an actual conflict between the two because compliance
with both is “a physical impossibility” or because state law stands “as an obstacle to
the accomplishment and execution of the full purposes and objectives of Congress.”

California Fed. Sav. & Loan Ass’n v. Guerra, 479 U.S. 272, 280 (1987).
Importantly, the Supreme Court has emphasized that there is a strong
presumption that “state or local regulation of matters related to health and safety is
not invalidated under the Supremacy Clause.” Hillsborough Cty., Fla. v. Automated

Med. Lab’s, Inc., 471 U.S. 707, 715 (1985). Federal preemption of a state health and
safety regulation will be found only in situations where it is “the clear and manifest
purpose of Congress.” CSX Transp., Inc. v. Easterwood, 507 U.S. 658, 664 (1993)
(courts “interpreting a federal statute pertaining to a subject traditionally governed
by state law will be reluctant to find pre-emption.”).
Preemption can be either by an express provision of a statute or conflict
preemption. “Express preemption occurs when Congress (or an agency) enacts a

22

Case 1:21-cv-00387-MSM-LDA Document 22 Filed 01/07/22 Page 23 of 25 PageID #: 547

statute (or a regulation) ‘containing an express preemption provision.’” Estes v.

ECMC Grp., Inc., 2021 U.S. Dist. LEXIS 138180, *39-40, 2021 DNH 117, 2021 WL
3146240 (D.N.H. July 26, 2021). Title VII clearly does not expressly preempt state
public-health regulations and the plaintiffs have not argued otherwise. Instead, they
argue that Rhode Island’s Regulation “directly interferes with Plaintiffs’ federal-law
rights under Title VII.” (ECF No. 2 at 4).

While the plaintiffs argue that the

Regulation “outright forbids Plaintiffs from even seeking (or retaining already
granted) reasonable accommodations from Covid-19 vaccination in accord with their
sincerely held religious beliefs” (ECF No. 2 at 5-6) that is not an accurate reading of
the text of the Regulation or the record in this case. Nothing in the language prevents
any employer from providing a reasonable accommodation to an employee who seeks
one in accord with their sincerely held religious beliefs. Indeed, the Regulation is
silent on the issue of religious exemptions.
Title VII requires employers to accommodate religious beliefs, practices, or
observances only to the extent that doing so would not impose “undue hardship” on
the employer. See 42 U.S.C. § 2000e(j)a. While the Regulation may make it more
difficult for employers to accommodate religious objections; it does not create a
“physical impossibility.” An unvaccinated health care worker without the limited
medical exemption may not enter a health care facility, but an employer may
“consider alternative work-conditions, such as telemedicine.” (ECF No. 16-1 ¶ 14).
The plaintiffs have presented an RIDOH Notice of Violation and Compliance
Order to a hospital in support of their argument that accommodations are impossible

23

Case 1:21-cv-00387-MSM-LDA Document 22 Filed 01/07/22 Page 24 of 25 PageID #: 548

for those declining the vaccine due to purported religious beliefs. (ECF No. 20.) In
at least one instance, the health care facility, response to the Notice of Violation,
determined the employee’s duties could not be performed off site and he or she was
placed on administrative leave. Id. What this indicates is that in some cases, due to
the need to limit the number of unvaccinated persons in a health care facility,
accommodation is not possible without an undue hardship on the employer. As the
First Circuit held regarding Maine’s COVID-19 vaccine requirement, “[t]he hospitals
need not provide the exemption the appellants request because doing so would cause
them to suffer undue hardship.” Mills, 16 F.4th at 36. See also Cloutier v. Costco

Wholesale, 311 F. Supp. 2d 190, 198 (D. Mass. 2004), aff’d, 390 F.3d 126 (1st Cir.
2004) (“[T]he accommodation offered by the employer does not have to be the best
accommodation possible, and the employer does not have to demonstrate that
alternative accommodations would be worse or impose an undue hardship.”).
Therefore, the plaintiffs have failed to make out a case of likelihood of success on the
merits on their Title VII claim.
Because the Plaintiffs have failed to establish a likelihood of success on the
merits as to any of their claims, the Court does not need to address the remaining
factors for injunctive relief.

See Sindicato Puertorriqueno de Trabajadores v.

Fortuno, 699 F.3d 1, 10 (1st Cir. 2012).
V.

CONCLUSION

For the foregoing reasons, the plaintiffs have not established they are likely to
succeed on the merits of their claims that the Regulation violates their constitutional

24

Case 1:21-cv-00387-MSM-LDA Document 22 Filed 01/07/22 Page 25 of 25 PageID #: 549

or statutory rights. The Court therefore will not enjoin the enforcement of the
Regulation.

The plaintiffs’ Motion for a Preliminary Injunction (ECF No. 2.) is

DENIED.

IT IS SO ORDERED.
_________________________________
Mary S. McElroy
United States District Judge
January 7, 2022

25