We the Patriots USA, Inc. v. Hochul Dr. A. v. Hochul

21-2179; 21-2566
We The Patriots USA, Inc. v. Hochul; Dr. A. v. Hochul

In the
United States Court of Appeals
For the Second Circuit
______________

August Term, 2021

(Argued: October 27, 2021 Decided: November 4, 2021)

Docket No. 21-2179
______________

WE THE PATRIOTS USA, INC., DIANE BONO, MICHELLE MELENDEZ,
MICHELLE SYNAKOWSKI,

Plaintiffs-Appellants,

–v.–

KATHLEEN HOCHUL, HOWARD A. ZUCKER, M.D.,

Defendants-Appellees.
___________________________

Docket No. 21-2566
______________

DR. A., NURSE A., DR. C., NURSE D., DR. F., DR. G., THERAPIST I.,
DR. J., NURSE J., DR. M., NURSE N., DR. O., DR. P., TECHNOLOGIST P., DR. S.,
NURSE S., PHYSICIAN LIAISON X.,

Plaintiffs-Appellees,

–v.–

KATHY HOCHUL, GOVERNOR OF THE STATE OF NEW YORK, IN HER OFFICIAL
CAPACITY, DR. HOWARD A. ZUCKER, COMMISSIONER OF THE NEW YORK STATE
 DEPARTMENT OF HEALTH, IN HIS OFFICIAL CAPACITY, LETITIA JAMES,
ATTORNEY GENERAL OF THE STATE OF NEW YORK, IN HER OFFICIAL CAPACITY,

Defendants-Appellants.

B e f o r e:

WALKER, SACK, and CARNEY, Circuit Judges.
______________

In these two cases on appeal, district courts in New York State considered
applications for preliminary injunctive relief that would restrain the State from
enforcing its emergency rule requiring healthcare facilities to ensure that certain
employees are vaccinated against COVID-19. See 10 N.Y.C.R.R. § 2.61 (Aug. 26, 2021)
(“Section 2.61”). The State issued Section 2.61 in response to rapidly increasing infection
rates related to the Delta variant of the virus. Section 2.61 contains an exemption for
employees who are unable to be safely vaccinated due to pre-existing medical
conditions, but does not contain an exemption for those who object to this vaccination
on religious grounds. Plaintiffs, individual healthcare workers who object to receiving
the vaccine because of their religious beliefs, as well as a membership organization,
filed complaints and motions for preliminary injunctive relief, asserting that Section
2.61 violates their rights under the First Amendment, the Fourteenth Amendment, and
the Supremacy Clause. In We The Patriots, filed in the U.S. District Court for the Eastern
District of New York, the district court (Kuntz, J.) denied the motion without opinion. In
Dr. A., filed in the U.S. District Court for the Northern District of New York, the district
court (Hurd, J.) granted the motion, deciding that Plaintiffs had established that Section
2.61 was likely neither neutral towards religion nor generally applicable, triggering
strict scrutiny under the First Amendment’s Free Exercise Clause, and that the State had
failed to establish that Section 2.61 was likely narrowly tailored to serve a compelling
government interest under strict scrutiny review. The district court in Dr. A. also
concluded that Section 2.61 was likely preempted by Title VII’s protection for
employees who require religious accommodations, and thus ran afoul of the Supremacy
Clause.

On appeal, focusing on the requirements for the grant of a preliminary
injunction, we conclude that Plaintiffs in both cases have failed to establish a likelihood

2
of success on any of their claims, and thus the Dr. A. district court’s issuance of a
preliminary injunction was in error. As to Plaintiffs’ Free Exercise claims, we conclude
that Plaintiffs have not shown that they are likely to succeed in establishing (1) that
Section 2.61 is not a neutral law of general applicability, or (2) that—in the resulting
inquiry—Section 2.61 does not satisfy rational basis review. Next, we determine that
Plaintiffs have not demonstrated a likelihood of success on their Supremacy Clause
claim: it appears to us fully possible for employers to comply with both Section 2.61 and
Title VII. Finally, we decide that Plaintiffs are not likely to succeed on their claims that
Section 2.61 contravenes the Fourteenth Amendment. The order of the U.S. District
Court for the Eastern District of New York is therefore AFFIRMED, the order of the U.S.
District Court for the Northern District of New York is REVERSED, and the preliminary
injunction entered by that court is VACATED. These tandem cases are REMANDED to
their respective district courts for further proceedings consistent with the Order entered
by this Court on October 29, 2021, and this Opinion.

______________

CAMERON L. ATKINSON (Norman A. Pattis, Earl A. Voss, on
the brief), Pattis & Smith, LLC, New Haven, CT, for
Plaintiffs-Appellants We The Patriots USA, Inc. et al. (in
No. 21-2179).

STEVEN C. WU, Deputy Solicitor General (Barbara D.
Underwood, Mark S. Grube, on the brief) for Letitia
James, Attorney General for the State of New York,
New York, NY, for Defendants-Appellants (in No. 21-
2566) and Defendants-Appellees (in No. 21-2179) Kathleen
Hochul et al.

CHRISTOPHER A. FERRARA (Michael McHale, Stephen M.
Crampton, on the brief), Thomas More Society,
Chicago, IL, for Plaintiffs-Appellees Dr. A. et al. (in No.
21-2566).

Alex J. Luchenister, Richard B. Katskee, Americans United
for Separation of Church and State, Washington, D.C.;
Daniel Mach, Heather L. Weaver, Lindsey Kaley,

3
 American Civil Liberties Union Foundation,
Washington, D.C. & New York, NY; Christopher
Dunn, Beth Haroules, Arthur Eisenberg, Amy Belsher,
New York Civil Liberties Union Foundation, New
York, NY, for Amici Curiae (in No. 21-2179) Americans
United for Separation of Church and State, American Civil
Liberties Union, New York Civil Liberties Union, Central
Conference of American Rabbis, Global Justice Institute,
Metropolitan Community Churches, Men of Reform
Judaism, Methodist Federation for Social Action, Muslim
Advocates, National Council of Jewish Women,
Reconstructionist Rabbinical Association, Union for
Reform Judaism, and Women of Reform Judaism.

Mark D. Harris, Shiloh Rainwater, Proskauer Rose LLP, New
York, NY, for Amicus Curiae (in No. 21-2179) Greater
New York Hospital Association.
______________

PER CURIAM:

In these two cases on appeal, which we consider in tandem, federal district

courts in New York State considered applications for preliminary injunctive relief that

would restrain the State from enforcing its emergency rule requiring healthcare facilities

to ensure that certain employees are vaccinated against COVID-19. See 10 N.Y.C.R.R.

§ 2.61 (Aug. 26, 2021) (“Prevention of COVID-19 transmission by covered entities”)

(“Section 2.61” or “the Rule”). The State issued the Rule in response to rapidly

increasing infection rates related to the Delta variant of the SARS-CoV-2 virus, a virus

that has caused widespread suffering in the State, country, and world since early 2020.

The State described the Rule’s purpose as primarily to preserve the health of healthcare

workers, and from that narrow purpose, more broadly, to keep patients and the public

safe from COVID-19. The Rule establishes a medical exemption to the vaccination

requirement, but—consistent with New York’s prior vaccination requirements for

4
healthcare workers—does not include an exemption based on religious belief. The Rule

permits, but does not require, employers to make other accommodations for individuals

who choose not to be vaccinated based on their sincere religious beliefs.

The moving parties—primarily healthcare workers allegedly affected by the

Rule—challenge the Rule’s omission of a religious exemption by asserting claims under

the First Amendment, the Supremacy Clause, and the Fourteenth Amendment. Both

groups of Plaintiffs moved to enjoin enforcement of the Rule. One district court granted

the preliminary relief requested, enjoining the Rule insofar as it prevented healthcare

workers from being eligible for an exemption based on religious belief; the other denied

it. See Dr. A. v. Hochul, No. 21-cv-1009, 2021 WL 4734404 (N.D.N.Y. Oct. 12, 2021)

(granting preliminary injunction) (“Dr. A.”); We The Patriots USA, Inc. v. Hochul, No. 21-

cv-4954 (E.D.N.Y. Sept. 12, 2021) (denying preliminary injunction) (“We The Patriots” or

“WTP”).

The individual plaintiffs in Dr. A. are nurses, doctors, and other personnel

employed by healthcare facilities in New York State; in We The Patriots, they are three

nurses similarly employed and a related nonprofit organization. All individual

plaintiffs aver that to receive any one of the three currently available vaccines against

COVID-19 (Pfizer-BioNTech, Moderna, and Johnson & Johnson) would violate their

religious beliefs because those vaccines were developed or produced using cell lines

derived from cells obtained from voluntarily aborted fetuses. They assert that their

employers have threatened them with adverse employment consequences if they refuse

to be vaccinated.

Plaintiffs argue, and the district court in Dr. A. held, that they are likely to

succeed in establishing that Section 2.61 violates their rights under the Free Exercise

Clause of the First Amendment and under the Supremacy Clause. As to the Free

Exercise Clause, Plaintiffs submit that because the State has afforded a medical

5
exemption to its requirement, the Free Exercise Clause requires the State also to afford a

religious exemption. With respect to the Supremacy Clause, the Dr. A. Plaintiffs argue

that the non-discrimination obligations placed on employers by Title VII of the Civil

Rights Act of 1964, 42 U.S.C. §§ 2000e et seq. (“Title VII”) preempt the State’s vaccination

Rule. As a third basis for relief, the WTP Plaintiffs allege that the Rule infringes their

rights to privacy and bodily integrity under the Fourteenth Amendment. Under the

familiar standards for a preliminary injunction that Plaintiffs must meet to obtain such

relief, Plaintiffs allege that, in addition to showing a likelihood of success on the merits,

they will suffer irreparable harm absent immediate relief and that the balance of the

equities and the public interest lie in their favor.

The State resists, contending primarily that Section 2.61 is a neutral provision of

general applicability to those covered by the Rule; that the Rule serves its goal and

compelling need to preserve the health of healthcare workers; that the medical and

religious exemptions would not be comparable for purposes of the Free Exercise Clause

analysis required by Employment Division, Department of Human Resources of Oregon v.

Smith, 494 U.S. 872 (1990), and its progeny; and that Plaintiffs have not shown a

likelihood of success on the merits on any of their claims or otherwise satisfied the

prerequisites for entry of the exceptional relief of a preliminary injunction at this phase

of the litigation.

Following oral argument, on October 29, 2021, this Court entered an Order

disposing of the appeals and advising that an Opinion would follow. This Opinion

explains the basis for that Order.

As to Plaintiffs’ Free Exercise claim, we conclude that Plaintiffs have not met

their burden to show that they are likely to succeed in establishing (1) that Section 2.61

is not a neutral law of general applicability under Smith, or (2) that—in the resulting

inquiry—Section 2.61 does not satisfy rational basis review. Next, we determine that

6
Plaintiffs have not demonstrated a likelihood of success on their Supremacy Clause

claim on the record before us, as Plaintiffs have not shown that it would likely be

impossible for employers to comply with both Section 2.61 and Title VII. Finally, we

decide that Plaintiffs are not likely to succeed on their claim that the Rule contravenes

the Fourteenth Amendment.

In light of these conclusions and of our further assessment of the irreparability of

the harm Plaintiffs allege, the balance of the hardships, and the public interest in

enforcing or not enforcing the Rule, we AFFIRM the order of the United States District

Court for the Eastern District of New York denying the motion for a preliminary

injunction in We The Patriots; and we REVERSE the order of the United States District

Court for the Northern District of New York granting Plaintiffs’ motion for the same

relief in Dr. A. and VACATE the related preliminary injunction entered by that court.

Finally, we REMAND both cases to their respective district courts for further

proceedings consistent with our October 29, 2021 Order, and this Opinion. We stress

that we do not now decide the ultimate merits of Plaintiffs’ legal claims or of the State’s

defenses; rather, we make a limited determination with respect to preliminary relief

based on the limited factual record presently before this Court.

BACKGROUND

I. New York’s Emergency Rule

On August 26, 2021, New York’s Department of Health adopted an emergency

rule directing hospitals, nursing homes, hospices, adult care facilities, and other

identified healthcare entities to “continuously require” certain of their employees to be

fully vaccinated against COVID-19 beginning on September 27, 2021, for “general

hospitals” and nursing homes, and on October 7, 2021, for all other “covered entities” as

7
defined in the Rule. 10 N.Y.C.R.R. § 2.61. 1 The vaccine requirement applies not to all

employees, but only to those covered by the Rule’s definition of “personnel”: those

employees, staff members, and volunteers “who engage in activities such that if they

were infected with COVID-19, they could potentially expose other covered personnel,

patients or residents to the disease.” Id. § 2.61(a)(2).

The Rule was issued by the State’s Public Health and Health Planning Council, a

group of 25 healthcare professionals, including the Commissioner of Health, that state

law charges with issuing regulations “affecting the security of life or health or the

preservation and improvement of public health,” including those addressing the control

of communicable diseases. N.Y. Pub. Health L. § 225(4), (5).

As required by New York law, the notice of emergency rulemaking included the

Council’s findings and a Regulatory Impact Statement (the “Statement”). See NYS

Admin. Proc. Act § 202(6). The Statement explained that the Rule responded to the

“significant public health threat” caused by the increasing circulation of the Delta

variant: “Since early July, cases have risen 10-fold, and 95 percent of the sequenced

recent positives in New York State were the Delta variant.” Dr. A. Sp. App’x at 39. It

also referenced data purporting to show “that unvaccinated individuals are

approximately 5 times as likely to be diagnosed with COVID-19 compared to

vaccinated individuals” and that “[t]hose who are unvaccinated have over 11 times the

risk of being hospitalized with COVID-19.” Id. It described vaccination as critical to

controlling the spread of the disease at healthcare facilities and in congregate care

settings, which “pose increased challenges and urgency for controlling the spread of

this disease because of [their] vulnerable patient and resident populations,”

determining that “[u]nvaccinated personnel in such settings have an unacceptably high

1 The complete text of Section 2.61 is provided in an Appendix to this Opinion.

8
risk of both acquiring COVID-19 and transmitting the virus to colleagues and/or

vulnerable patients or residents, exacerbating staffing shortages, and causing

unacceptably high risk of complications.” Id. As an emergency rule, Section 2.61 is in

effect for a maximum of 90 days, expiring on November 23, 2021, unless renewed. See

id. at 38; NYS Admin. Proc. Act § 202(6)(b).

Section 2.61 exempts from the vaccination requirement “personnel” for whom

“immunization with COVID-19 vaccine is detrimental to [their] health . . . , based upon

a pre-existing health condition” as more specifically defined and limited by the Rule. 10

N.Y.C.R.R. § 2.61(d)(1). 2 The medical exemption applies “only until such immunization

is found no longer to be detrimental to [their] health.” Id. It must be supported with a

certification by a licensed physician or certified nurse practitioner issued in accordance

2 The full text of this medical exemption under Section 2.61(d)(1) reads as follows:

(1) Medical exemption. If any licensed physician or certified nurse
practitioner certifies that immunization with COVID-19 vaccine is
detrimental to the health of member of a covered entity’s personnel, based
upon a pre-existing health condition, the requirements of this section relating
to COVID-19 immunization shall be inapplicable only until such
immunization is found no longer to be detrimental to such personnel
member’s health. The nature and duration of the medical exemption must be
stated in the personnel employment medical record, or other appropriate
record, and must be in accordance with generally accepted medical
standards, (see, for example, the recommendations of the Advisory
Committee on Immunization Practices of the U.S. Department of Health and
Human Services), and any reasonable accommodation may be granted and
must likewise be documented in such record. Covered entities shall
document medical exemptions in personnel records or other appropriate
records in accordance with applicable privacy laws by: (i) September 27, 2021
for general hospitals and nursing homes; and (ii) October 7, 2021 for all other
covered entities. For all covered entities, documentation must occur
continuously, as needed, following the initial dates for compliance specified
herein, including documentation of any reasonable accommodation therefor.

10 N.Y.C.R.R. § 2.61(d)(1).

9
with generally accepted medical standards, including recommendations of the

Advisory Committee on Immunization Practices (“ACIP”) of the U.S. Department of

Health and Human Services. Id.; see also N.Y. State Department of Health, Frequently

Asked Questions (FAQs) Regarding the August 26, 2021 – Prevention of COVID-19

Transmission by Covered Entities Emergency Regulation, https://coronavirus.health.ny.gov/

system/files/documents/2021/09/faqs-for-10-nycrr-section-2.61-9-20-21.pdf (last visited

November 2, 2021) (“FAQs”). Section 2.61 contains no “exemption” for personnel who

oppose vaccination on religious or any other grounds not covered by the medical

exemption; however, as we discuss below, the Rule does not prohibit employers from

providing religious objectors with accommodations.

On August 18, 2021, eight days before the Council promulgated Section 2.61, New

York State Commissioner of Health Dr. Howard A. Zucker, acting alone, had issued an

“Order for Summary Action” (“the August 18 Order” or “the Order”) under the

authority vested in him by New York Public Health Law § 16. See Dr. A. Sp. App’x at

41–47. Section 16 permits the Commissioner to issue a short-term order—effective for a

maximum of 15 days—if he identifies a condition that in his view constitutes a “danger

to the health of the people.” N.Y. Pub. Health Law § 16. After making findings about

the dangers of COVID-19, the Order similarly required certain healthcare facilities to

ensure that certain personnel were fully vaccinated against COVID-19 by September 27,

2021, but differed from Section 2.61, which superseded it, in several respects. Most

relevant here, the Order included a religious exemption for personnel who “hold a

genuine and sincere religious belief contrary to the practice of immunization.” Dr. A.

Sp. App’x at 45–46. In addition, the Order could be effective for only a very brief period

of time—for up to 15 days—whereas the Rule could be in effect for up to 90 days,

subject to extensions. Further, the Order applied only to “general hospital[s]” and

nursing homes; Section 2.61 applies more broadly, to all hospitals, nursing homes,

10
diagnostic and treatment centers, home healthcare agencies and similar programs,

hospices, and adult care facilities. Id. at 43; 10 N.Y.C.R.R. § 2.61(a)(1).

In affidavits appended to its briefing to this Court and filed in other pending

proceedings, 3 the State has provided preliminary vaccination data from the months of

August through October 2021. It reflects a significant increase in vaccination rates

among covered healthcare personnel that occurred after the Rule’s effective date on

September 27 (even though the Rule was subject to the temporary restraining order and

later injunction issued in Dr. A.). As of August 24, the State’s declarant reported, 71% of

workers at nursing homes and 77% of workers at adult care facilities had received at

least one dose of the vaccine; 77% of workers at hospitals were fully vaccinated. See

WTP Appellees’ Add. at 14–15 (Decl. of Elizabeth Rausch-Phung). As of October 19,

97.4% of workers at nursing homes and 96.7% of workers at adult care facilities had

received at least one dose of the vaccine, and 91.4% of workers at hospitals were fully

vaccinated. See Serafin v. New York State Dep’t of Health, Index No. 908296-21, Doc. Nos.

56. (Decl. of Valerie A. Deetz), 57 (Decl. of Dorothy Persico) (Sup. Ct. Albany County

Oct. 20, 2021). Also as of October 19, between 0.4% and 0.5% of workers at each facility

3 We may take judicial notice of the existence of affidavits filed in another court. See Glob.
Network Commc'ns, Inc. v. City of New York, 458 F.3d 150, 157 (2d Cir. 2006). In addition, our
Court has ruled that courts may consider hearsay evidence such as affidavits when determining
whether to grant a preliminary injunction. See Mullins v. City of New York, 626 F.3d 47, 52 (2d
Cir. 2010); see also Univ. of Tex. v. Camenisch, 451 U.S. 390, 395 (1981) (observing that preliminary
injunctive determinations may be based on “procedures that are less formal and evidence that is
less complete than in a trial on the merits”). Thus, we consider the State’s data submitted in
affidavits filed in other courts. Although this data was not before the district court in WTP—and
therefore Plaintiffs have not had an opportunity to contest its accuracy before the district
court—they have not raised such a concern in their reply brief in WTP or at oral argument, nor
have they challenged this Court’s ability to consider the State’s submissions. More broadly,
Plaintiffs do not appear to contest the State’s assertion derived from this data that religious
exemptions are more common than medical exemptions, but instead consider this fact
irrelevant.

11
type were medically ineligible to receive the COVID-19 vaccine, whereas 1.9% of

workers at nursing homes and adult care facilities and 1.3% of workers at hospitals

claimed “other” exemptions, which the State describes as reflecting religious

exemptions permitted by the injunction entered in Dr. A. Id.

II. The District Court Proceedings

Plaintiffs in We The Patriots are a membership organization and three nurses

working in hospital facilities in New York State. 4 Plaintiffs in Dr. A. are nurses, doctors,

and others employed at healthcare facilities in New York State. In both cases, the

defendants include Governor Kathleen Hochul and Commissioner Zucker; the Dr. A.

Plaintiffs also named New York Attorney General Letitia James as a defendant.

All Plaintiffs assert that they object on religious grounds to receiving the COVID-

19 vaccines as briefly described above. As public health authorities have explained, in

the 1970s and 1980s, cell lines were derived from fetal cells obtained from elective

abortions or miscarriages. 5 These cell lines have since been used in the development of

various vaccines. 6 They were used for testing in the research and development phase of

4 Plaintiff We The Patriots USA, Inc., states that it is a section 501(c)(3) organization that “is
dedicated to promoting constitutional rights and other freedoms through education, outreach,
and public interest litigation, thereby advancing religious freedom, medical freedom, parental
rights, and educational freedom for all.” WTP App’x at 8.

5 See, e.g., Los Angeles County Dep’t of Pub. Health, COVID-19 Vaccine and Fetal Cell Lines (Apr.
20, 2021), http://publichealth.lacounty.gov/media/coronavirus/docs/vaccine/
VaccineDevelopment_FetalCellLines.pdf; Michigan Dep’t of Health & Human Servs., COVID-19
Vaccines & Fetal Cells (Apr. 21, 2021), https://www.michigan.gov/documents/coronavirus/
COVID-19_Vaccines_and_Fetal_Cells_031921_720415_7.pdf; North Dakota Dep’t of Health,
COVID-19 Vaccines & Fetal Cell Lines (Apr. 20, 2021), https://www.health.nd.gov/sites/www/
files/documents/COVID%20Vaccine%20Page/COVID-19_Vaccine_Fetal_Cell_Handout.pdf.

6These cell lines “have been used to create vaccines for diseases such as hepatitis A, rubella, and
rabies. Abortions from which fetal cells were obtained were elective and were not done for the

12
the mRNA (Pfizer-BioNTech and Moderna) COVID-19 vaccines and in the production

of the Johnson & Johnson COVID-19 vaccine. 7 Plaintiffs assert that, in these

circumstances, receiving any of the three available COVID-19 vaccines would conflict

with their deeply held religious beliefs.

A. We The Patriots USA, Inc. v. Hochul

In We The Patriots, the three individual plaintiffs are registered nurses. Diane

Bono and Michelle Melendez are employed at Syosset Hospital in Syosset, and Michelle

Synakowski is employed at St. Joseph’s Hospital in Syracuse. On September 2, 2021, one

week after the Rule was adopted, Plaintiffs sued Governor Hochul and Commissioner

Zucker in the United States District Court for the Eastern District of New York, alleging

that the Rule violates their First Amendment right to exercise their religion freely. They

also charged that it violates their rights to privacy and “medical freedom,” which they

locate in the First, Fourth, Fifth, and Fourteenth Amendments. They asked the district

purpose of vaccine development.” Los Angeles County Dep’t of Pub. Health, COVID-19 Vaccine
and Fetal Cell Lines, supra note 5.

7 The use of these cell lines was explained in press statements and publicly available research
during the development of the COVID-19 vaccines. See Press Release, Johnson & Johnson,
Johnson & Johnson Announces a Lead Vaccine Candidate for COVID-19; Landmark New
Partnership with U.S. Department of Health & Human Services; and Commitment to Supply
One Billion Vaccines Worldwide for Emergency Pandemic Use (Mar. 30, 2020),
https://www.jnj.com/johnson-johnson-announces-a-lead-vaccine-candidate-for-covid-19-
landmark-new-partnership-with-u-s-department-of-health-human-services-and-commitment-
to-supply-one-billion-vaccines-worldwide-for-emergency-pandemic-use (describing use of
PER.C6 cell line in Johnson & Johnson vaccine); Annette B. Vogel et al., A Prefusion SARS-Cov-2
Spike RNA Vaccine Is Highly Immunogenic and Prevents Lung Infection in Non-human Primates,
bioRxiv (Sept. 8, 2020), https://doi.org/10.1101/2020.09.08.280818 (referencing use of HEK293 cell
line in early testing stages of Pfizer-BioNTech vaccine); Kizzmekia S. Corbett et al., SARS-CoV-2
mRNA Vaccine Design Enabled by Prototype Pathogen Preparedness, 586 Nature 567, 572 (Oct. 22,
2020), https://doi.org/10.1038/s41586-020-2622-0 (referencing use of HEK293 cell line in testing of
Moderna vaccine).

13
court to declare Section 2.61 unconstitutional and permanently enjoin the State from

enforcing it.

Ten days later, the WTP Plaintiffs moved for a temporary restraining order and a

preliminary injunction immediately enjoining the State from enforcing the Rule. They

argued that immediate relief was essential because Section 2.61 puts them at imminent

risk of losing their jobs if they persist in refusing vaccination. In support of their motion,

they provided letters from Nurse Bono’s and Nurse Melendez’s employer, Northwell

Health, a private entity. 8 In the letter received by Nurse Bono, dated August 31,

Northwell Health advised that her “continued employment will be at risk” if she did

not receive the vaccine by the deadline. WTP App’x 32. In its letter to Nurse Melendez,

dated August 30, Northwell Health wrote only that Nurse Melendez would be required

to undergo weekly PCR testing and would be unable to participate in certain meetings,

gatherings, and events based on her vaccination status. 9

The district court denied Plaintiffs’ motion on September 12, the day it was filed,

without explanation and without ordering or receiving a response from the State.

Plaintiffs timely appealed.

B. Dr. A. v. Hochul

In Dr. A., 17 medical professionals who work in New York sued Governor

Hochul, Commissioner Zucker, and Attorney General James on September 13 in the

United States District Court for the Northern District of New York, seeking declaratory

8 They did not name Northwell Health as a defendant or seek relief against it.

9In their brief on appeal, the WTP Plaintiffs state that Northwell Health terminated Nurse
Bono’s employment on September 29. The WTP Plaintiffs also assert that Nurse Synakowski
was informed by her employer that her employment would be terminated by September 21 if
she was not vaccinated by then, but in their briefs filed since that date they have not stated
whether that came to pass.

14
and injunctive relief preventing the enforcement of the Rule. 10 In their verified

complaint, they alleged three bases of unconstitutionality. First, they contended that the

Rule infringes on religious rights secured by the Free Exercise Clause by requiring that

they be vaccinated, contrary to their religious beliefs. Second, they claimed that Section

2.61 violates the Supremacy Clause because it is preempted by Title VII, which prohibits

discrimination in employment based on religion. Third, they claimed that Section 2.61

runs afoul of the Equal Protection Clause because it prevents them from seeking a

religious accommodation while at the same time allowing similarly situated healthcare

workers to seek a medical accommodation.

The Dr. A. Plaintiffs simultaneously moved for a temporary restraining order

and preliminary injunction. They sought immediate injunctive relief, citing “imminent

irreparable harm from loss of employment and professional standing” as a result of

their “religiously motivated refusal to be vaccinated.” Dr. A. App’x at 207.

On September 14, the district court granted Plaintiffs’ motion for a temporary

restraining order, enjoining the State from enforcing any requirement that employers

deny religious exemptions from the vaccine requirement or that employers revoke any

religious exemption already granted, and directed the State to file its opposition to

Plaintiffs’ request for a preliminary injunction. Six days later, the district court extended

the temporary restraining order for 14 days, pending its written opinion on Plaintiffs’

request for a preliminary injunction to be issued on or before October 12.

On October 12, the district court issued the requested preliminary injunction,

resting in part on its determination that Plaintiffs were likely to succeed on their Free

Exercise claim. The district court concluded that Plaintiffs had established that Section

The district court granted a request by the Dr. A. Plaintiffs to proceed pseudonymously. The
10

Dr. A. Plaintiffs do not identify their employers in their complaint.

15
2.61 is neither a neutral law nor one of general applicability. It also ruled that Section

2.61 is likely to fail strict scrutiny. See Dr. A., 2021 WL 4734404, at *8–9. The district court

further concluded that Plaintiffs were likely to succeed on their Title VII preemption

claim, reasoning that Section 2.61 “effectively foreclose[s] the pathway to seek[] a

religious accommodation that is guaranteed under Title VII.” Id. at *6. 11

The State timely appealed. 12

DISCUSSION

Issuance of a preliminary injunction is an “extraordinary and drastic remedy”

that is “never awarded as of right.” Munaf v. Geren, 553 U.S. 674, 689–90 (2008) (quoting

11A C. Wright, A. Miller, & M. Kane, Federal Practice and Procedure § 2948, at 129 (2d

ed. 1995)). Preliminary injunctive relief “should not be routinely granted.” Hanson Tr.

PLC v. SCM Corp., 774 F.2d 47, 60 (2d Cir. 1985) (quoting Medical Soc. of State of N.Y. v.

11The district court declined to consider the merits of Plaintiffs’ Equal Protection claim.
Plaintiffs do not pursue this claim on appeal.

12Having lost before the district court in the Eastern District on September 12—before the Dr. A.
court entered its temporary restraining order (on September 14) or its preliminary injunction
(on October 12)—the WTP Plaintiffs successfully sought interim relief from the September 28
motions panel in this Court. Motion Order, WTP, No. 21-2179, Dkt. No. 65 (Sept. 30, 2021). Oral
argument on their appeal from the denial of a preliminary injunction was scheduled to be heard
on an expedited basis on October 14 by a duly convened regular argument panel—the panel
that now files this opinion per curiam. Case Calendaring, WTP, No. 21-2179, Dkt. No. 68. When
the district court in the Northern District granted the Dr. A. Plaintiffs’ request for a preliminary
injunction on October 12, the State promptly appealed. Notice of Appeal, Dr. A., No. 21-2566,
Dkt. No. 1. Because the two cases request virtually identical relief and offer overlapping
arguments, we determined not to hear the WTP Plaintiffs’ appeal on October 14, separate from
the State appeal in Dr. A., but rather to hear the cases in tandem. We scheduled the combined
oral argument for October 27, again on an expedited basis and with full briefing by the Dr. A.
Plaintiffs and the State. Order, WTP, No. 21-2179, Dkt. No. 116; Dr. A., No. 21-2566, Dkt. No. 8.
The parties helpfully coordinated their oral argument presentations to avoid needless
repetition.

16
Toia, 560 F.2d 535, 537 (2d Cir. 1977)). When deciding whether to issue a preliminary

injunction, courts “should pay particular regard for the public consequences in

employing the extraordinary remedy of injunction.” Winter v. Nat. Res. Def. Council, Inc.,

555 U.S. 7, 24 (2008).

To obtain a preliminary injunction that “will affect government action taken in

the public interest pursuant to a statute or regulatory scheme, the moving party must

demonstrate (1) irreparable harm absent injunctive relief, (2) a likelihood of success on

the merits, and (3) public interest weighing in favor of granting the injunction.” 13

Agudath Israel of Am. v. Cuomo, 983 F.3d 620, 631 (2d Cir. 2020) (internal quotation marks

omitted). The movant must also show that the balance of equities supports the issuance

of an injunction. See Yang v. Kosinski, 960 F.3d 119, 127 (2d Cir. 2020). We review the

grant or denial of a motion for a preliminary injunction for abuse of discretion. See

Freedom Holdings, Inc. v. Spitzer, 408 F.3d 112, 114 (2d Cir. 2005). A district court has

exceeded the permissible bounds of its discretion when its “decision rests on an error of

law (such as application of the wrong legal principle) or a clearly erroneous factual

finding” or “cannot be located within the range of permissible decisions.”

13In Dr. A., the district court applied the likelihood-of-success standard, and the Dr. A. Plaintiffs
do not now argue that this was error. The parties in WTP, in contrast, cite our Court’s
alternative, less demanding “serious questions” standard for obtaining preliminary injunctive
relief, which authorizes injunctive relief if the movant has shown imminent irreparable harm as
well as “sufficiently serious questions going to the merits of its claims to make them fair ground
for litigation, plus a balance of the hardships tipping decidedly in favor of the moving party.”
New York ex rel. Schneiderman v. Actavis PLC, 787 F.3d 638, 650 (2d Cir. 2015) (internal quotation
marks omitted). But we have consistently applied the likelihood-of-success standard to cases
challenging government actions taken in the public interest pursuant to a statutory or
regulatory scheme, including in cases involving emergency regulations and orders. See, e.g.,
Agudath Israel, 983 F.3d at 631; Alleyne v. New York State Educ. Dep’t, 516 F.3d 96, 99–101 (2d Cir.
2008). The WTP parties have not explained why the “serious questions” standard should
nonetheless govern here. Accordingly, in our review of both appeals, we apply the likelihood-
of-success standard.

17
Mastrovincenzo v. City of New York, 435 F.3d 78, 88 (2d Cir. 2006) (internal quotation

marks omitted).

Because the issues and arguments presented by these two appeals overlap

substantially, we consider them together, issue by issue, differentiating between them

only as we think necessary. 14

I. Likelihood of Success on the Merits: Free Exercise of Religion Claim

Plaintiffs contend that Section 2.61 violates their rights under the Free Exercise

Clause of the First Amendment because it does not include an exemption for employees

who oppose receiving the vaccine on religious grounds.

On a motion for preliminary injunction, the movants must show that they are

likely to prevail on their claim that the challenged government action is unlawful. On

the record before us, we conclude that neither the Dr. A. Plaintiffs nor the WTP

Plaintiffs have established a likelihood of success on their Free Exercise claims such that

they are entitled to the “extraordinary relief” of a preliminary injunction. The district

court’s conclusion to the contrary in Dr. A. was legal error and rested on clearly

erroneous findings of fact.

A. The Smith Standard

The First Amendment forbids the enactment of laws, either state or federal, that

“prohibit[] the free exercise” of religion. 15 U.S. Const., amend. I. But not all laws that

14Although the district court’s order denying the WTP Plaintiffs’ motion did not state the basis
for its decision, we may “affirm on any ground supported by the record.” NXIVM Corp. v. Ross
Inst., 364 F.3d 471, 476 (2d Cir. 2004).

15In relevant part, the First Amendment provides that “Congress shall make no law respecting
an establishment of religion, or prohibiting the free exercise thereof.” The stricture has been

18
burden an individual’s exercise of religion contravene this deeply rooted prohibition.

Nor do they always trigger heightened scrutiny. The Supreme Court has long applied

the standard set out by Justice Scalia for the Court in Employment Division v. Smith to

determine whether a democratically enacted law that burdens religious practice is

properly considered under rational basis review or strict scrutiny. See 494 U.S. at 879;

Fulton v. City of Philadelphia, 141 S. Ct. 1868, 1876 (2021).

Under Smith, a “neutral law of general applicability” is subject to rational basis

review even if it incidentally burdens a particular religious practice. 494 U.S. at 878–79;

see also Church of the Lukumi Babalu Aye, Inc. v. City of Hialeah, 508 U.S. 520, 531 (1993).

We have observed that “[t]he teaching of Smith is that a state can determine that a

certain harm should be prohibited generally, and a citizen is not, under the auspices of

her religion, constitutionally entitled to an exemption.” Central Rabbinical Congress of the

U.S. & Canada v. N.Y.C. Dep’t of Health & Mental Hygiene, 763 F.3d 183, 196 (2d Cir. 2014).

But if a law is not neutral towards religion or is not generally applicable, it falls outside

the boundaries of Smith. Then, for such a law to survive, it “must be justified by a

compelling governmental interest and must be narrowly tailored to advance that

interest.” Lukumi, 508 U.S. at 531–32.

Because they seek a preliminary injunction, Plaintiffs bear the initial burden of

establishing a likelihood of success on the merits. In the context of their First

Amendment claim, this means that Plaintiffs must show that they are likely to succeed

on their claim that Section 2.61 is not a neutral or generally applicable rule. If they

succeed at that step, the burden shifts to the State to show that it is likely to succeed in

defending the challenged Rule under strict scrutiny. Cf. Gonzales v. O Centro Espirita

Beneficente Uniao do Vegetal, 546 U.S. 418, 429 (2006) (“[T]he burdens at the preliminary

held to limit the authorities of the states as well. See Cantwell v. Connecticut, 310 U.S. 296, 303
(1940).

19
injunction stage track the burdens at trial.”). We conclude that, at this stage, Plaintiffs

have not carried their initial burden of showing that Section 2.61 is likely not neutral or

generally applicable.

B. Neutrality

The State “fails to act neutrally when it proceeds in a manner intolerant of

religious beliefs or restricts practices because of their religious nature.” Fulton, 141 S. Ct.

at 1877; see also Lukumi, 508 U.S. at 532 (First Amendment protections apply when “the

law at issue discriminates against some or all religious beliefs or regulates or prohibits

conduct because it is undertaken for religious reasons”). A law may be not neutral if it

explicitly singles out a religious practice, but even a facially neutral law will run afoul of

the neutrality principle if it “targets religious conduct for distinctive treatment.”

Lukumi, 508 U.S. at 533–34.

The Supreme Court has explained that “[a] law lacks facial neutrality if it refers

to a religious practice without a secular meaning discernable from the language or

context.” Id. at 533. Section 2.61 is facially neutral because it does not single out

employees who decline vaccination on religious grounds. It applies to all “personnel,”

as carefully defined in the Rule, aside from those who qualify for the narrowly framed

medical exemption.

Plaintiffs nonetheless maintain that the regulation “targets” them because of

their religious opposition to receiving any one of the three currently available COVID-

19 vaccines. In support, they point to events preceding the enactment of Section 2.61

and to several of Governor Hochul’s public comments during the month of September

as reflective of discriminatory intent on the part of the State. We take these claims in

order.

20
 First, Plaintiffs argue that the fact that the August 18 Order contained a religious

exemption, but Section 2.61 does not, demonstrates that in Section 2.61 the State

intended to “target” those who object to vaccination on religious grounds, and that this

reflects anti-religion animus. The district court in Dr. A. agreed, finding that the

difference between the two government actions amounted to a “religious

gerrymander.” Dr. A., 2021 WL 4734404, at *8 (quoting Lukumi, 508 U.S. at 535).

Specifically, the district court determined that Section 2.61, enacted eight days after the

August 18 Order, intentionally “amended the [August 18 Order] to eliminate the

religious exemption.” Id. As a result, the district court concluded that Plaintiffs had

established a likelihood that Section 2.61 was non-neutral based on their argument that

it “effectively targets religious opposition to the available COVID-19 vaccines.” Id.

In Lukumi, the Supreme Court determined that the municipal ordinance at issue,

which prohibited animal sacrifice, was not neutral because it effectively prohibited

conduct only undertaken by adherents to the Santeria religion as a part of their religious

practice. See 508 U.S. at 534–35. In contrast, Section 2.61 requires all covered employees

who can safely receive the vaccine to be vaccinated. It applies whether an employee is

eager to be vaccinated or strongly opposed, and it applies whether an employee’s

opposition or reluctance is due to philosophical or political objections to vaccine

requirements, concerns about the vaccine’s efficacy or potential side effects, or religious

beliefs. The absence of a religious exception to a law does not, on its own, establish non-

neutrality such that a religious exception is constitutionally required.

Further, that the August 18 Order contained a religious exemption, while Section

2.61 does not, falls short of rendering Section 2.61 non-neutral. The historical

background of Section 2.61, to be determined following discovery, may be relevant to

fully discerning the State’s intent, but the evidence before the district courts failed to

raise an inference that the regulation was intended to be a “covert suppression of

21
particular religious beliefs.” New Hope Family Servs., Inc. v. Poole, 966 F.3d 145, 163 (2d

Cir. 2020) (quoting Lukumi, 508 U.S. at 534). In suggesting that Section 2.61 “eliminated”

the religious exemption, WTP Appellants’ Br. at 10, Plaintiffs misconstrue the

connection between the August 18 Order and the August 26 Rule. 16 The August 18

Order was issued by Commissioner Zucker alone as an emergency measure, intended

to be in place for a maximum of 15 days, in response to reports of the surging Delta

variant. Section 2.61, in contrast, was issued following collective deliberation by the 25-

member Public Health and Health Planning Council under the emergency rulemaking

procedures set forth in New York law, which provided more process, public input, and

support for a measure that would be effective for 90 days subject to renewal. These

procedures required the Council, among other things, to develop and issue specific

findings and a regulatory impact statement. NYS Admin. Proc. Act § 202(6)(iv), (viii).

After this extensive process, the full Council came to the conclusion that the vaccine

requirement should apply to a broader set of healthcare entities and, consistent with the

State’s highly effective existing vaccine requirements for measles and rubella (issued

with no religious exemption), see 10 N.Y.C.R.R. §§ 405.3, 415.26, 751.6, 763.13, 766.11,

794.3, 1001.11, should not contain a religious exemption. The Council did not amend the

August 18 Order: rather, it independently promulgated a new Rule. The record before

the district courts does not demonstrate that the Rule was intended to “target”

16In a recent decision, the First Circuit similarly misunderstood the connection between the
August 18 Order and August 26 Rule when attempting to distinguish the New York vaccination
mandate from the Maine vaccination mandate. See Does 1-6 v. Mills, — F.4th —, 2021 WL
4860328 (1st Cir. Oct. 19, 2021), application for injunctive relief denied sub nom. Does 1-3 v. Mills, —
S. Ct. —, No. 21A90, 2021 WL 5027177 (Oct. 29, 2021). The First Circuit mistakenly wrote, “Eight
days after New York officials promulgated a version of the regulation containing a religious
exemption, they amended the regulation to eliminate the religious exemption.” Id. at *9.
However, as we explain above, there was no “amending” of the regulation to remove a
religious exemption. Rather, the August 18 Order and the August 26 Rule were issued through
two separate processes.

22
individuals opposed to receiving the COVID-19 vaccines because of their religious

beliefs.

Additionally, much occurred in the time between August 18 and August 26:

former Governor Andrew Cuomo resigned and Governor Hochul assumed office; 17 the

FDA gave full approval to the Pfizer-BioNTech vaccine for individuals 16 years of age

and older; 18 and the Delta variant continued its spread, becoming the dominant strain of

the virus in the State. 19 Even if the differing August 18 and August 26 requirements can

be said to represent a shift in the State’s policy position, Plaintiffs have not adduced

facts establishing that the change stemmed from religious intolerance, rather than an

intent to more fully ensure that employees at healthcare facilities receive the vaccine in

furtherance of the State’s public health goals. 20

Second, on appeal, Plaintiffs assert that certain comments made by Governor

Hochul in September reveal that Section 2.61 was intended to target them because of

their religious opposition to the required vaccination. 21 Some of those comments,

17New York State Governor’s Office, Video, Audio, Photos & Rush Transcript: Kathy Hochul Is
Sworn in as 57th Governor of New York State (Aug. 24, 2021),
https://www.governor.ny.gov/news/video-audio-photos-rush-transcript-kathy-hochul-sworn-
57th-governor-new-york-state.

18Press Release, U.S. Food and Drug Administration, FDA Approves First COVID-19 Vaccine
(Aug. 23, 2021), https://www.fda.gov/news-events/press-announcements/fda-approves-first-
covid-19-vaccine.

19 See Dr. A. Sp. App’x at 39.

20This is another area in which factual development can be expected to shed more light on the
circumstances surrounding the creation of both the Order and the Rule and validate or disprove
Plaintiffs’ allegations.

21Governor Hochul made the statements at issue after both the Dr. A. Plaintiffs and the WTP
Plaintiffs filed their preliminary injunction motions.

23
however, did not relate to Section 2.61 or workplace vaccine requirements at all,

including Governor Hochul’s statements at church services in which she urged those in

attendance to get vaccinated. 22 Governor Hochul’s expression of her own religious

belief as a moral imperative to become vaccinated cannot reasonably be understood to

imply an intent on the part of the State to target those with religious beliefs contrary to

hers; otherwise, politicians’ frequent use of religious rhetoric to support their positions

would render many government actions “non-neutral” under Smith. At a press briefing

on September 15, in which she responded to the temporary restraining order issued in

Dr. A., Governor Hochul stated her “personal opinion” that no religious exemption is

required and that she was “not aware of” any “sanctioned religious exemption from

any organized religion.” 23 This comment simply mirrors the State’s litigation position

and conveys the fact—which Plaintiffs do not contest—that many religious leaders have

stated that vaccination is consistent with their faiths. 24 Governor Hochul’s comments

may more reasonably be understood to express general support for religious principles

22See New York State Governor’s Office, Rush Transcript: Governor Hochul Attends Service at
Christian Cultural Center (Sept. 26, 2021), https://www.governor.ny.gov/news/rush-transcript-
governor-hochul-attends-service-christian-cultural-center; New York State Governor’s Office,
Video, Audio, Photos & Rush Transcript: Governor Hochul Attends Services at Abyssinian
Baptist Church in Harlem (Sept. 12, 2021), https://www.governor.ny.gov/news/video-audio-
photos-rush-transcript-governor-hochul-attends-services-abyssinian-baptist-church.

23See New York State Governor’s Office, Video & Rush Transcript: Governor Hochul Holds
Q&A Following COVID-19 Briefing (Sept. 15, 2021), https://www.governor.ny.gov/news/video-
rough-transcript-governor-hochul-holds-qa-following-covid-19-briefing.

24See, e.g., Devin Watkins, Pope Francis Urges People to Get Vaccinated Against Covid-19, Vatican
News (Aug. 18, 2021), https://www.vaticannews.va/en/pope/news/2021-08/popefrancis-appeal-
covid-19-vaccines-act-of-love.html; Chairmen of the Committee on Doctrine and the Committee
on Pro-Life Activities, Moral Considerations Regarding the New COVID-19 Vaccines, U.S. Conf. of
Catholic Bishops (Dec. 11, 2020), https://www.usccb.org/moral-considerations-covid-vaccines.

24
that she believes guide community members to care for one another by receiving the

COVID-19 vaccine.

Altogether, Governor Hochul’s comments, even considered in light of the

differing approaches taken by Commissioner Zucker in the August 18 Order and the

full Council in the Rule, do not evince animosity towards particular religious practices

or a desire to target religious objectors to the vaccine requirement because of their

religious beliefs. Rather, they suggest that the State wanted more people to obtain the

vaccine out of a deep concern for public health, which is a religion-neutral government

interest.

We therefore conclude that Plaintiffs at this stage have not carried their burden

of establishing that Section 2.61 is likely not neutral. The district court’s contrary

conclusion in Dr. A. was based on a clearly erroneous assessment of the record before it.

C. General Applicability

As the Supreme Court recently explained in Fulton v. City of Philadelphia, a law

may not be “generally applicable” under Smith for either of two reasons: first, “if it

invites the government to consider the particular reasons for a person’s conduct by

providing a mechanism for individualized exemptions”; or, second, “if it prohibits

religious conduct while permitting secular conduct that undermines the government’s

asserted interests in a similar way.” 141 S. Ct. at 1877 (internal quotation marks and

alterations omitted). Here, Plaintiffs’ argument, in substance, is that because Section

2.61 includes a medical exemption, it is not “generally applicable.”

1. Whether Section 2.61 Permits “Comparable” Secular Conduct

The general applicability requirement “protects religious observers against

unequal treatment, and inequality that results when a legislature decides that the

governmental interests it seeks to advance are worthy of being pursued only against

25
conduct with a religious motivation.” Central Rabbinical Congress, 763 F.3d at 196–97

(alterations omitted) (quoting Lukumi, 508 U.S. at 542–43). 25 “A law is therefore not

generally applicable if it is substantially underinclusive such that it regulates religious

conduct while failing to regulate secular conduct that is at least as harmful to the

legitimate government interests purportedly justifying it.” Id. at 197. As the Supreme

Court stated in a recent order, “whether two activities are comparable for purposes of

the Free Exercise Clause must be judged against the asserted government interest that

justifies the regulation at issue.” Tandon v. Newsom, 141 S. Ct. 1294, 1296 (2021).

“Comparability is concerned with the risks various activities pose.” Id. Notably, in

Smith, a law criminalizing controlled substance possession was deemed generally

applicable even though it contained an exception for substances prescribed for medical

purposes. 494 U.S. at 874, 878–82.

The State alleges that the following interests underlie its adoption of Section 2.61.

First, it seeks to prevent the spread of COVID-19 in healthcare facilities among staff,

patients, and residents. Second, by protecting the health of healthcare employees to

ensure they are able to continue working, it aims to reduce the risk of staffing shortages

that can compromise the safety of patients and residents even beyond a COVID-19

infection. Thus, the State maintains, the medical and any religious exemption differ in

25Plaintiffs suggest that our decision in Central Rabbinical Congress was overruled by the
Supreme Court’s orders in Roman Catholic Diocese and Tandon. But Central Rabbinical Congress’s
formulation of the standard for identifying “comparable secular activity”—“secular conduct
that is at least as harmful [as religious conduct] to the legitimate government interests
purportedly justifying it,” 763 F.3d at 197—is consistent with the Supreme Court’s statements in
both of those cases. See Roman Catholic Diocese of Brooklyn v. Cuomo, 141 S. Ct. 63, 67 (2020)
(stating that less-regulated factories, schools, and shopping centers were much more crowded
than churches and synagogues or had contributed to the spread of COVID-19, in contrast to the
religious institutions’ “admirable safety records”); Tandon v. Newsom, 141 S. Ct. 1294, 1297 (2021)
(considering secular activities comparable where they were not found to “pose a lesser risk of
transmission than [plaintiffs’] proposed religious exercise at home”).

26
an important respect: applying the Rule to those who oppose vaccination on religious

grounds furthers the State’s asserted interests, whereas applying the Rule to those

subject to medical contraindications or precautions based on pre-existing conditions

would undermine the government’s asserted interest in protecting the health of covered

personnel. Cf. Does 1-6 v. Mills, — F.4th —, 2021 WL 4860328, at *6 (1st Cir. Oct. 19,

2021), application for injunctive relief denied sub nom. Does 1-3 v. Mills, — S. Ct. —, No.

21A90, 2021 WL 5027177 (Oct. 29, 2021). Vaccinating a healthcare employee who is

known or expected to be injured by the vaccine would harm her health and make it less

likely she could work. The State identified these objectives in the Regulatory Impact

Statement accompanying the emergency rulemaking, and Plaintiffs do not point to any

evidence suggesting that the interests asserted are pretextual or should otherwise be

disregarded in the comparability analysis. Accordingly, the State makes a reasonable

case that Section 2.61 contains a medical exemption not because it determined that “the

governmental interests it seeks to advance are worthy of being pursued only against

conduct with a religious motivation,” Lukumi, 508 U.S. at 543, but because applying the

vaccination requirement to individuals with medical contraindications and precautions

would not effectively advance those interests. Indeed, applying the vaccine to

individuals in the face of certain contraindications, depending on their nature, could

run counter to the State’s “interest in protecting the integrity and ethics of the medical

profession.” Gonzales v. Carhart, 550 U.S. 124, 157 (2007) (quoting Washington v.

Glucksberg, 521 U.S. 702, 731 (1997)); see also Jacobson v. Massachusetts, 197 U.S. 11, 38–39

(1905) (recognizing that the state may not be permitted to require vaccination of

individuals with contraindications).

Importantly, the State has also presented evidence that raises the possibility that

the exemptions are not comparable in terms of the “risk” that they pose. See Tandon, 141

S. Ct. at 1296. It notes that the medical exemption is defined to be limited in duration, as

27
the vaccine requirement is “inapplicable only until such immunization is found no

longer to be detrimental to such personnel member’s health.” 10 N.Y.C.R.R. § 2.61(d)(1).

Although some of the contraindications and precautions identified by ACIP and

incorporated into the Department of Health guidance are long-term health conditions,

others are in fact explicitly temporary, such as having a current moderate-to-severe

acute illness. 26 In contrast, a sincerely held religious belief that vaccination is

inconsistent with one’s religion is unlikely to change to permit vaccination in the future,

absent the approval of new vaccines that are developed in a different way. The statistics

provided by the State further indicate that medical exemptions are likely to be more

limited in number than religious exemptions, and that high numbers of religious

exemptions appear to be clustered in particular geographic areas. See Dr. A. Appellants’

Reply Br. at 13 (citing Serafin, Index No. 908296-21, Doc. No. 57 (Decl. of Dorothy

Persico)) (ratios of religious exemptions to medical exemptions among Erie County and

Monroe County hospital workers were 18 to 1 and 23 to 1, respectively). 27

As a result, it may be feasible for healthcare entities to manage the COVID-19

risks posed by a small set of objectively defined and largely time-limited medical

exemptions. In contrast, it could pose a significant barrier to effective disease

prevention to permit a much greater number of permanent religious exemptions,

which, according to the State’s evidence, appear more commonly sought in certain

locations. See Serafin, Index No. 908296-21, Doc. No. 57 (Decl. of Dorothy Persico).

Although these differences may, after factual development, be shown to be too

insignificant to render the exemptions incomparable, the limited evidence now before

26 See FAQs, supra at 10.

27As discussed, Plaintiffs do not contest the State’s assertion that higher numbers of employees
claim religious exemptions than medical exemptions. See supra note 3.

28
us suggests that the medical exemption is not “as harmful to the legitimate government

interests purportedly justifying” the Rule as a religious exemption would be. Central

Rabbinical Congress, 763 F.3d at 197.

In their efforts to show a likelihood of success on the merits, Plaintiffs counter

that Section 2.61, by providing a medical but not a religious exemption, effectively

prohibits religion-based refusals of vaccination while permitting “comparable” refusals

on secular grounds. To establish comparability under Smith, Plaintiffs rely heavily on

the general—and reasonable—proposition that any individual unvaccinated employee

is likely to present statistically comparable risks of both contracting and spreading

COVID-19 at any given healthcare facility, irrespective of the reason that the employee

is unvaccinated. In Plaintiffs’ view, the Supreme Court’s orders in Roman Catholic

Diocese of Brooklyn v. Cuomo and Tandon v. Newsom require us to confine our analysis to

evaluating the risk of COVID-19 transmission posed by each unvaccinated individual.

Both of those cases involved challenges to occupancy limits placed on religious

services, in an effort to curb COVID-19 transmission indoors, which were not applied to

secular businesses with similarly high capacities. See Roman Catholic Diocese of Brooklyn

v. Cuomo, 141 S. Ct. 63, 67 (2020); Tandon, 141 S. Ct. at 1297. Unlike Plaintiffs’ proposed

analysis here, however, Roman Catholic Diocese and Tandon did not involve a one-to-one

comparison of the transmission risk posed by an individual worshipper and, for

example, an individual grocery shopper. The Supreme Court’s discussion in those

cases, which compared the risks posed by groups of various sizes in various settings,

suggests the appropriateness of considering aggregate data about transmission risks.

See, e.g., Roman Catholic Diocese, 141 S. Ct. at 66–67 (comparing “a large store in Brooklyn

that could literally have hundreds of people shopping there on any given day” with “a

nearby church or synagogue [that] would be prohibited from allowing more than 10 or

25 people for a worship service”). We doubt that, as an epidemiological matter, the

29
number of people seeking exemptions is somehow excluded from the factors that the

State must take into account in assessing the relative risks to the health of healthcare

workers and the efficacy of its vaccination strategy in actually preventing the spread of

disease. The record before us contains only limited data regarding the prevalence of

medical ineligibility and religious objections, but what data we do have indicates that

claims for religious exemptions are far more numerous.

Further, Tandon expressly instructs courts to consider “the asserted government

interest that justifies the regulation at issue” when determining whether two activities

are comparable for Free Exercise Clause purposes. Tandon, 141 S. Ct. at 1296. By

confining their discussion of comparability to individual risk of transmission alone,

Plaintiffs fail to engage with the reasons above, persuasive to us, that substantially

distinguish the medically ineligible from the religious objectors in light of the State’s

asserted purposes. At this stage, Plaintiffs do not meaningfully challenge the legitimacy

of the government’s asserted interest in protecting the health of workers and

maintaining staffing levels, or the proposition that requiring those who have been

granted a medical exemption to be vaccinated would undermine those interests to a

lesser degree than would a religious exemption.

As counsel for the WTP Plaintiffs acknowledged at oral argument, Plaintiffs here

essentially contend that all existing vaccination mandates without a religious exemption

necessarily fail the general applicability test because they likely all contain medical

exemptions. At the same time, it appears that for decades, those charged with

protecting the public health against infectious disease in New York State have required

vaccination of all medically eligible employees and treated the requirement as a

condition of employment in the healthcare arena. For example, the State has required

healthcare employees to be vaccinated against rubella and measles since 1980 and 1991,

respectively, without a religious exemption. Many of these vaccines, including the

30
rubella vaccine, appear from the information available to us (and not to date contested

by Plaintiffs) to have connections to the same fetal cell lines that form the basis for

Plaintiffs’ religious objections here. See Los Angeles County Dep’t of Pub. Health,

COVID-19 Vaccine and Fetal Cell Lines, supra note 5. Thus, if accepted, Plaintiffs’

arguments would go beyond just being inconsistent with past practices: they would

have potentially far-reaching and harmful consequences for governments’ ability to

enforce longstanding public health rules and protocols.

With a record as undeveloped on the issue of comparability as that presented

here, we cannot conclude that the above vaccination requirements are per se not

generally applicable, as Plaintiffs’ argument would have it, so as to support a

preliminary injunction at this time. See Smith, 494 U.S. at 888–89 (counting “compulsory

vaccination laws” among those generally applicable civic obligations for which no

religious exemption is required); see also Prince v. Massachusetts, 321 U.S. 158, 166–67

(1944) (“[A parent] cannot claim freedom from compulsory vaccination for the child

more than for himself on religious grounds. The right to practice religion freely does not

include liberty to expose the community or the child to communicable disease . . . .”

(footnote omitted)); Phillips v. City of New York, 775 F.3d 538, 543 (2d Cir. 2015) (per

curiam) (maintaining that religious exemptions to vaccine mandates are not

constitutionally required).

The record before the district courts was sparse. It does not support a conclusion

that Plaintiffs have borne their burden of demonstrating that the medical exemption

provided in Section 2.61 and the religious exemption sought are likely comparable.

2. Whether Section 2.61 Provides for a System of Individualized Exemptions

General applicability may be absent when a law provides “a mechanism for

individualized exemptions,” Smith, 494 U.S. at 884, because it creates the risk that

31
administrators will use their discretion to exempt individuals from complying with the

law for secular reasons, but not religious reasons. For instance, in Smith, the Supreme

Court distinguished generally applicable laws from an unemployment compensation

statute under which applicants were eligible for benefits if they presented “good cause”

for their unemployment, which allowed administrators, in their discretion, to refuse an

exemption if an applicant could not work for religious reasons, but to grant an

exemption if an applicant could not work for other personal reasons. 494 U.S. at 884

(quoting Bowen v. Roy, 476 U.S. 693, 708 (1986) (plurality opinion) and citing Sherbert v.

Verner, 374 U.S. 398, 401 & n.4 (1963)). The Court observed that the context of the

unemployment compensation system “lent itself to individualized government

assessment of the reasons for the relevant conduct.” Id. Similarly, the Court recently

found a system of individualized exemptions to exist where an official had “sole

discretion” to grant or deny exemptions to the anti-discrimination provision in

contracts between the City of Philadelphia and adoption service providers. Fulton, 141

S. Ct. at 1878–79.

As other Circuits have noted, however, “an exemption is not individualized

simply because it contains express exceptions for objectively defined categories of

persons.” 303 Creative LLC v. Elenis, 6 F.4th 1160, 1187 (10th Cir. 2021) (internal

quotation marks and alteration omitted); see also Stormans, Inc. v. Wiesman, 794 F.3d

1064, 1081–82 (9th Cir. 2015) (finding that the challenged “rules do not afford unfettered

discretion that could lead to religious discrimination because the provisions are tied to

particularized, objective criteria”), cert. denied, 136 S. Ct. 2433 (2016); cf. Intercommunity

Ctr. for Justice & Peace v. I.N.S., 910 F.2d 42, 45 (2d Cir. 1990) (concluding that

immigration law that prohibited knowingly employing an unauthorized immigrant did

“not provide for a discretionary exemption that is applied in a manner that fails to

accommodate free exercise concerns” despite its inclusion of an exemption for

32
employing certain household employees hired before November 1986). The “mere

existence of an exemption procedure,” absent any showing that secularly motivated

conduct could be impermissibly favored over religiously motivated conduct, is not

enough to render a law not generally applicable and subject to strict scrutiny. Lighthouse

Inst. for Evangelism, Inc. v. City of Long Branch, 510 F.3d 253, 276 (3d Cir. 2007).

The WTP Plaintiffs argue that the medical exemption in Section 2.61 creates a

mechanism for individualized exemptions. They are mistaken. The medical exemption

here does not “‘invite’ the government to decide which reasons for not complying with

the policy are worthy of solicitude.” Fulton, 141 S. Ct. at 1879 (quoting Smith, 494 U.S. at

884). Instead, the Rule provides for an objectively defined category of people to whom

the vaccine requirement does not apply: employees who present a certification from a

physician or certified nurse practitioner attesting that they have a pre-existing health

condition that renders the vaccination detrimental to their health, in accordance with

generally accepted medical standards, such as those published by ACIP, 28 for the period

28 Under the generally accepted medical standards published by ACIP, cognizable
contraindications to the COVID-19 vaccines are limited to “[s]evere allergic reaction (e.g.,
anaphylaxis) after a previous dose or to a component of the COVID-19 vaccine” and
“[i]mmediate (within 4 hours) allergic reaction of any severity to a previous dose or known
(diagnosed) allergy to a component of the COVID-19 vaccine.” FAQs, supra at 10 (citing ACIP
standards). Precautions to the vaccines are limited to “[c]urrent moderate to severe acute
illness[,] . . . [h]istory of an immediate allergic reaction to any other (not COVID-19) vaccine or
injectable therapy (excluding allergy shots)[, and] [h]istory of myocarditis or pericarditis after
receiving the first dose of an mRNA COVID-19 vaccine.” Id. (citing ACIP standards).
Additionally, individuals with a “contraindication to one type of COVID-19 vaccine (e.g.,
mRNA COVID-19 vaccines) have precautions to another type of COVID-19 vaccine (e.g.,
Janssen/Johnson & Johnson vaccine).” Id. (citing ACIP standards). An individual who has a
contraindication to the vaccine cannot be safely vaccinated, but “[m]ost people deemed to have
a precaution to a COVID-19 vaccine at the time of their vaccination appointment can and
should be administered vaccine” after conducting a risk assessment with a healthcare provider.
Centers for Disease Control and Prevention, Interim Clinical Considerations for Use of COVID-19
Vaccines Currently Approved or Authorized in the United States: Contraindications and Precautions
(Oct. 25, 2021), https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-

33
during which the vaccination remains detrimental to their health. See 10 N.Y.C.R.R.

§ 2.61(d)(1). A written description of the nature and duration of the condition must be

furnished, and the exemption must be documented. On its face, the Rule affords no

meaningful discretion to the State or employers, and Plaintiffs have not put forth any

evidence suggesting otherwise. For example, Plaintiffs have not plausibly alleged or

offered evidence to suggest that employees are requesting, or that the State is allowing,

medical exemptions that do not conform to the Rule or applicable standards.

That physicians and nurse practitioners must use their medical judgment to

determine whether a particular individual has a contraindication or precaution against

receiving the vaccine does not render the exemption discretionary. Indeed, Smith itself

specifically held that a scheme that included a type of medical exemption—by not

criminalizing the use of controlled substances when prescribed by a medical

practitioner—was nonetheless generally applicable under the Free Exercise Clause. See

Smith, 494 U.S. at 874. If the State can lawfully choose to apply the vaccination

requirement to those with religious objections but not those medically unable to get

vaccinated because the two are not comparable—and, as explained above, Plaintiffs

have not established a likelihood of success on their argument to the contrary—then

Section 2.61 appears to leave no room for the State to favor impermissible secular

reasons for declining vaccination over religious reasons. 29

vaccines-us.html#Contraindications. The specificity of these limitations stands in contrast to the
absence of limitations and specificity in the medical exemption provided in the Maine statute
recently subject to review and consideration by the Supreme Court. See Mills, 2021 WL 4860328,
at *5 (construing Me. Rev. Stat. tit. 22, § 802); Mills, 2021 WL 5027177, at *2 (Gorsuch, J.,
dissenting from the denial of application for injunctive relief) (stating that the law does not
“limit what may qualify as a valid ‘medical’ reason to avoid inoculation”).

29In Dahl v. Bd. of Trustees of Western Michigan Univ., — F.4th —, 2021 WL 4618519 (6th Cir. Oct.
7, 2021) (per curiam), the Sixth Circuit, under different factual circumstances, ruled that a
student-athlete vaccine mandate that provided that medical and religious exemptions would be

34
 ***

Based on the foregoing, Plaintiffs have not established, at the preliminary

injunction stage, that they are likely to succeed in showing that Section 2.61 is not

neutral or generally applicable. Accordingly, rational basis review applies. See Fulton,

141 S. Ct. at 1876 (citing Smith, 494 U.S. at 878–82). Section 2.61 easily meets that

standard, which requires that the State have chosen a means for addressing a legitimate

goal that is rationally related to achieving that goal. See Jacoby & Meyers, LLP v. Presiding

Justices of the First, Second, Third and Fourth Dep’ts, App. Div. of the Sup. Ct. of N.Y., 852

F.3d 178, 191 (2d Cir. 2017). Faced with an especially contagious variant of the virus in

the midst of a pandemic that has now claimed the lives of over 750,000 in the United

States and some 55,000 in New York, the State decided as an emergency measure to

require vaccination for all employees at healthcare facilities who might become infected

and expose others to the virus, to the extent they can be safely vaccinated. This was a

reasonable exercise of the State’s power to enact rules to protect the public health. 30 See

Jacobson, 197 U.S. at 25; Phillips, 775 F.3d at 542–43.

considered on an individual basis at the discretion of the University meant that the school’s
vaccine mandate was not generally applicable under Fulton. Id. at *1, *4. We of course are not
bound by that analysis, and we believe Dahl to have addressed a factual setting significantly
different from that presented here. In Dahl, the University was afforded so much discretion to
rule on individual cases, and so few standards governed the exercise of that discretion, as to
leave room for the University to apply potentially discriminatory standards, or at least to avoid
a neutral application of generally applicable principles. See id. at *4. Here, we think the
standards articulated by ACIP and binding the State employers are sufficiently well-defined to
avoid grossly pretextual or discriminatory application—and Plaintiffs have not met their
burden to show that is not the case. Examined at a proper perspective—one suitable to dealing
with large populations in a public health crisis—we see no basis for adopting the Dahl court’s
approach here.

30We also observe that, irrespective of whether Section 2.61 is ultimately upheld at the
conclusion of this litigation, private healthcare institutions may impose vaccination
requirements of their own, subject to any relevant limitations imposed by Title VII and other
applicable law but regardless of the limitations that the First Amendment imposes on the State.

35
II. Likelihood of Success on the Merits: Supremacy Clause and Title VII Claim

The Dr. A. Plaintiffs contend that Section 2.61 contravenes the Supremacy Clause

because it is preempted by Title VII, which prohibits discrimination in employment on

the basis of religion. 42 U.S.C. § 2000e-2(a)(1)–(2). To succeed on this type of preemption

claim, plaintiffs must show that “local law conflicts with federal law such that it is

impossible for a party to comply with both or the local law is an obstacle to the

achievement of federal objectives.” N.Y. SMSA Ltd. P’ship v. Town of Clarkstown, 612 F.3d

97, 104 (2d Cir. 2010). 31

Plaintiffs construe Section 2.61 to prohibit healthcare employers from making

reasonable accommodations as otherwise required by Title VII. Plaintiffs cite the

absence of an express religious exemption in Section 2.61 in support of their position

that the Rule simply leaves “no room for Plaintiffs’ employers even to consider their

reasonable religious accommodation requests as required by federal law under Title

VII.” Dr. A. Appellees’ Br. at 29 (emphasis omitted). 32

31“In general, three types of preemption exist: (1) express preemption, where Congress has
expressly preempted local law; (2) field preemption, where Congress has legislated so
comprehensively that federal law occupies an entire field of regulation and leaves no room for
state law; and (3) conflict preemption, where local law conflicts with federal law such that it is
impossible for a party to comply with both or the local law is an obstacle to the achievement of
federal objectives.” N.Y. SMSA Ltd. P’ship, 612 F.3d at 104 (internal quotation marks omitted).
Plaintiffs here invoke conflict preemption.

32Although the Dr. A. Plaintiffs style their preemption claim as a challenge brought pursuant to
the Supremacy Clause, the Supreme Court has held that the Supremacy Clause does not create
an independent cause of action. See Armstrong v. Exceptional Child Ctr., Inc., 575 U.S. 320, 324–25
(2015) (“[T]he Supremacy Clause is not the source of any federal rights, and certainly does not
create a cause of action. It instructs courts what to do when state and federal law clash, but is
silent regarding who may enforce federal laws in court, and in what circumstances they may do
so.”) (internal quotation marks and citations omitted).

36
 The District Court for the Northern District of New York agreed, ruling that

Plaintiffs were likely to succeed on the merits of this claim. See Dr. A., 2021 WL 4734404,

at *6. The district court held that Section 2.61 “do[es] not make room for ‘covered

entities’ to consider requests for reasonable religious accommodations,” and instead

requires all personnel at covered entities to be vaccinated. Id. The district court

observed that the employers of some Plaintiffs had revoked previously afforded

religious exemptions or religious accommodations to COVID-19-vaccine requirements,

citing the State’s adoption of Section 2.61. Id. In the district court’s view, Plaintiffs

adequately demonstrated that Section 2.61 “effectively foreclose[s] the pathway to

seeking a religious exemption that is guaranteed under Title VII.” Id.

Title VII makes it unlawful for employers “to discharge . . . or otherwise to

discriminate against any individual” in his or her employment “because of such

individual’s . . . religion.” 42 U.S.C. § 2000e-2(a)(1). The statute defines “religion” to

include “all aspects of religious observance and practice, as well as belief, unless an

employer demonstrates that he is unable to reasonably accommodate . . . an

employee’s . . . religious observance or practice without undue hardship on . . . the

employer’s business.” Id. § 2000e(j); see Trans World Airlines, Inc. v. Hardison, 432 U.S. 63,

66 (1977); cf. EEOC v. Abercrombie & Fitch Stores, Inc., 575 U.S. 768, 770 (2015).

The Dr. A. Plaintiffs argue, as described above, that the absence of a religious

exemption in Section 2.61 prohibits them from seeking reasonable accommodations

from their employers under Title VII for their sincerely held religious beliefs. Section

2.61 is silent, however, on the employment-related actions that employers may take in

response to employees who refuse to be vaccinated for religious reasons. The State

observes that “[n]othing in [Section 2.61] precludes employers from accommodating

religious objectors by giving them . . . assignments—such as telemedicine—where they

37
would not pose a risk of infection to other personnel, patients, or residents.” Dr. A.

Appellants’ Br. at 62. We agree with the State.

Section 2.61, on its face, does not bar an employer from providing an employee

with a reasonable accommodation that removes the individual from the scope of the

Rule. Section 2.61 does not require employers to violate Title VII because, although it

bars an employer from granting a religious exemption from the vaccination requirement,

it does not prevent employees from seeking a religious accommodation allowing them to

continue working consistent with the Rule, while avoiding the vaccination requirement.

See also Mills, 2021 WL 4860328, at *10 (“The appellants’ Supremacy Clause argument

rests on their assertion that the hospitals . . . have claimed that the protections of Title

VII are inapplicable in the State of Maine. The record simply does not support that

argument. . . . [T]he hospitals merely dispute that Title VII requires them to offer the

appellants the religious exemptions they seek.” (internal quotation marks and alteration

omitted)).

Contrary to the Dr. A. Plaintiffs’ interpretation of the statute, Title VII does not

require covered entities to provide the accommodation that Plaintiffs prefer—in this

case, a blanket religious exemption allowing them to continue working at their current

positions unvaccinated. To avoid Title VII liability for religious discrimination, an

employer “need not offer the accommodation the employee prefers.” Cosme v.

Henderson, 287 F.3d 152, 158 (2d Cir. 2002). Instead, an employer must offer a reasonable

accommodation that does not cause the employer an undue hardship. Once “any

reasonable accommodation is provided, the statutory inquiry ends.” Id. Because Section

2.61’s text does not foreclose all opportunity for Plaintiffs to secure a reasonable

accommodation under Title VII, the Rule does not conflict with federal law. Therefore,

the district court’s conclusion to the contrary constituted legal error.

38
 The district court’s conclusion also turned on clearly erroneous factual findings.

At this stage, the Dr. A. Plaintiffs have submitted little in support of their broad

allegations about the effect of Section 2.61. The district court reached the conclusion that

accommodation by their employers was foreclosed upon the Dr. A. Plaintiffs’ say-so,

without any documentation supporting Plaintiffs’ allegations that they were denied

reasonable accommodations from their employers. The district court granted the Dr. A.

Plaintiffs’ motion for a preliminary injunction without a hearing and without knowing

the identities of Plaintiffs’ employers or the substance of Plaintiffs’ interactions with

their employers. It may turn out that the opportunities for a reasonable accommodation

under Title VII for religious objectors to the vaccine are numerous, or it may be that

there are so few as to be illusory. Perhaps accommodations for the medically ineligible

leave few available for the religious objectors.33 Or perhaps the requests for

accommodations in each category will vary by employer, by part of the State, or by

employee demographics. But without any data in the record, we cannot conclude that

Plaintiffs have met their burden to show a likelihood of success on the merits, and we

decline to draw any conclusion about the availability of reasonable accommodation

based solely on surmise and speculation.

At this preliminary stage, we therefore conclude that the district court erred by

finding that Plaintiffs are likely to succeed on their claim that Section 2.61 is preempted

by Title VII and therefore violative of the Supremacy Clause.

33Although the Rule does not prevent healthcare entities from taking additional precautions to
minimize the transmission risk posed by medically exempt employees, healthcare entities may
permit a medically exempt employee to continue normal job responsibilities provided they
comply with requirements for personal protective equipment. See FAQs, supra at 10.

39
III. Likelihood of Success on the Merits: Rights to Privacy, Medical Freedom, and
Bodily Autonomy Claim

The WTP Plaintiffs maintain on appeal that they are likely to succeed in

establishing that Section 2.61 violates their fundamental rights to privacy, medical

freedom, and bodily autonomy under the Fourteenth Amendment. 34 This argument also

fails.

Both this Court and the Supreme Court have consistently recognized that the

Constitution embodies no fundamental right that in and of itself would render vaccine

requirements imposed in the public interest, in the face of a public health emergency,

unconstitutional. See Jacobson, 197 U.S. at 25–31, 37; Phillips, 775 F.3d at 542–43.

Plaintiffs’ argument that the Supreme Court’s decision in Roman Catholic Diocese

“expressly overruled” Jacobson is a mystery, given that the majority did not even

mention Jacobson. WTP Appellants’ Br. at 35; see generally Roman Catholic Diocese, 141 S.

Ct. 63.

Their alternative contention that Jacobson and Phillips have been implicitly

overruled by the Supreme Court likewise finds no support in caselaw. In Cruzan, a case

relied upon by Plaintiffs for the proposition that they have a fundamental constitutional

right to refuse medical treatment, the Court expressly recognized its holding in Jacobson

that “an individual’s liberty interest in declining an unwanted smallpox vaccine” was

outweighed there by “the State’s interest in preventing disease.” Cruzan by Cruzan v.

34The WTP Plaintiffs’ complaint describes these rights as arising from the First, Fourth, Fifth,
and Fourteenth Amendments, but on appeal they assert that these rights are derived from either
the Fourteenth Amendment alone or a combination of the First, Fourth, Fifth, Ninth, and
Fourteenth Amendments. Because the WTP Plaintiffs do not make any particularized argument
for why the fundamental rights they assert may be implicated by constitutional provisions other
than the Fourteenth Amendment, we evaluate only their challenge as to the Fourteenth
Amendment.

40
Dir., Missouri Dep’t of Health, 497 U.S. 261, 278 (1990). Plaintiffs provide no basis for

concluding that the vaccination requirement here, considerably narrower than the city-

wide mandate in Jacobson, violates a fundamental constitutional right. 35 Although

individuals who object to receiving the vaccines on religious grounds have a hard

choice to make, they do have a choice. Vaccination is a condition of employment in the

healthcare field; the State is not forcibly vaccinating healthcare workers. As in Phillips,

the instant “challenge to the mandatory vaccination regime is therefore no more

compelling than Jacobson’s was more than a century ago.” 775 F.3d at 542. Cf. Klaassen

v. Trs. of Indiana Univ., 7 F.4th 592, 593 (7th Cir. 2021) (“[S]uch [a substantive due

process] argument depends on the existence of a fundamental right ingrained in the

American legal tradition. Yet Jacobson, which sustained a criminal conviction for

refusing to be vaccinated, shows that plaintiffs lack such a right.”).

Accordingly, the WTP Plaintiffs have not established that they are likely to

succeed on the merits of their Fourteenth Amendment claim.

IV. Irreparable Harm, the Public Interest, and the Balance of Equities

Plaintiffs are not entitled to a preliminary injunction because they cannot, on the

present record, show a likelihood of success on the merits. We nonetheless briefly

address the remaining preliminary injunction requirements: “irreparable harm absent

35Plaintiffs’ reliance on Roe v. Wade, 410 U.S. 113 (1973), Planned Parenthood v. Casey, 505 U.S. 833
(1992), and Lawrence v. Texas, 539 U.S. 558 (2003), also fails to persuade. These cases do not
establish a broad fundamental privacy right for all medical decisions made by an individual—
and particularly not for a decision with such broad community consequences as declining
vaccination against a highly contagious disease while working in contact with vulnerable
people at healthcare facilities. This Court cannot find an overriding privacy right when doing so
would conflict with Jacobson. Although in 1905, when it was decided, Jacobson might have been
read more narrowly, for over 100 years it has stood firmly for the proposition that the urgent
public health needs of the community can outweigh the rights of an individual to refuse
vaccination. Jacobson remains binding precedent.

41
injunctive relief”; the “public interest weighing in favor of granting the injunction”; and

“the balance of equities tip[ping] in [the movant’s] favor,” Yang, 960 F.3d at 127, and

determine that Plaintiffs have not successfully met them.

A. Irreparable Harm

The law recognizes the harm that necessarily results when the State

unconstitutionally burdens religious exercise. “Religious adherents are not required to

establish irreparable harm independent of showing a Free Exercise Clause violation

because a presumption of irreparable injury flows from a violation of constitutional

rights.” Agudath Israel, 983 F.3d at 636 (internal quotation marks and alteration omitted);

see also Bery v. City of New York, 97 F.3d 689, 693 (2d Cir. 1996) (“Violations of First

Amendment rights are commonly considered irreparable injuries for the purposes of a

preliminary injunction.”). Although Plaintiffs are subject to meaningful burdens on

their religious practice if they choose to obtain the COVID-19 vaccine, because they

have failed to demonstrate a likelihood of success on their First Amendment or other

constitutional claims, their asserted harm is not of a constitutional dimension. Thus,

Plaintiffs fail to meet the irreparable harm element simply by alleging an impairment of

their Free Exercise right.

Plaintiffs also contend that they face imminent irreparable harm from loss of

employment and professional standing if they refuse the COVID-19 vaccine on religious

grounds. We acknowledge that Plaintiffs may possibly suffer significant employment

consequences if they refuse on religious grounds to be vaccinated. It is well settled,

however, that adverse employment consequences are not the type of harm that usually

warrants injunctive relief because economic harm resulting from employment actions is

typically compensable with money damages. See Sampson v. Murray, 415 U.S. 61, 91–92

(1974) (“[L]oss of income and . . . the claim that her reputation would be damaged . . .

falls far short of the type of irreparable injury which is a necessary predicate to the

42
issuance of a temporary injunction[.]”); Savage v. Gorski, 850 F.2d 64, 68 (2d Cir. 1988)

(“Since reinstatement and money damages could make appellees whole for any loss

suffered during this period, their injury is plainly reparable and appellees have not

demonstrated the type of harm entitling them to injunctive relief.”). Because Plaintiffs’

economic harms under Title VII could be remedied with money damages, and

reinstatement is a possible remedy as well, we conclude that Plaintiffs have failed to

demonstrate that they will suffer irreparable harm absent injunctive relief.

We pause to recognize, should the issue remain on remand, that this case raises

difficult, apparently unusual questions as to imminent irreparable harm. Perhaps, if

they prevail at the conclusion of this litigation, Plaintiffs would seek lost wages, but it is

not at all clear who would pay them. To the extent Plaintiffs allege that they will suffer

adverse employment consequences or loss of professional standing if not provided

accommodations under Title VII, Plaintiffs might seek money damages from their

employers. Private medical-provider employers might make a persuasive argument

that they should not have to pay because they were in effect compelled by law to

terminate the employment. Absent a waiver, however, sovereign immunity would

likely prevent Plaintiffs from obtaining money damages from the State. See Virginia

Office for Prot. & Advocacy v. Stewart, 563 U.S. 247, 254 (2011).

We emphasize, however, that we do not place any weight on the issue of

remediation of Plaintiffs’ financial losses at this preliminary injunction stage. The

district courts can consider the issue, should it be necessary to do so, upon a

determination of the permanent injunction request, presumably upon further factual

development and findings.

43
 B. Public Interest and Balance of Equities

Plaintiffs have also failed to demonstrate that the public interest weighs in favor

of enjoining enforcement of Section 2.61. When the government is a party to the suit,

our inquiries into the public interest and the balance of the equities merge. See New York

v. United States Dep’t of Homeland Sec., 969 F.3d 42, 58–59 (2d Cir. 2020). Here, the State

has an indisputably compelling interest in ensuring that the employees who care for

hospital patients, nursing home residents, and other medically vulnerable people in its

healthcare facilities are vaccinated against COVID-19, not just to protect them and those

with whom they come into contact from infection, but also to prevent an overburdening

of the healthcare system. Although Plaintiffs undoubtedly face a difficult choice if their

employers deny religious accommodations—whether to be vaccinated despite their

religious beliefs or whether to risk termination of their jobs—such hardships are

outweighed by the State’s interest in maintaining the safety within healthcare facilities

during the pandemic.

Plaintiffs assert that the State “will suffer no harm as the New York healthcare

system has operated for the last year without interruption or catastrophe” without

requiring vaccination for healthcare workers. WTP Appellants’ Br. at 11. Defining the

relevant time frame in this way notably omits the first wave of the pandemic, during

which New York hospitals were in crisis, with frontline nurses and physicians

reportedly experiencing some of the highest rates of infection and death; New York City

nursing homes experienced such a high number of deaths that their morgue capacity

was exceeded. See Br. for Amicus Curiae Greater New York Hospital Association

(“GNYHA Amicus Br.”) at 3 (citing Miriam Mutambudzi et al., Occupation and Risk of

Severe COVID-19: Prospective Cohort Study of 120 075 UK Biobank Participants, 78

Occupational & Envt’l Med. 307, 311 (2021)); New York State Office of the Attorney

44
General, Nursing Home Response to COVID-19 Pandemic 12 (Jan. 30, 2021),

https://ag.ny.gov/sites/default/files/2021-nursinghomesreport.pdf.

But even within the past year, healthcare facilities in the State have been under

strain. According to amicus Greater New York Hospital Association, not only has

transmission of the virus continued in hospitals even with the use of personal protective

equipment, testing, and other measures, see GNYHA Amicus Br. at 9, 12–14, but hospital

workers have also experienced a “parallel pandemic” of burnout, anxiety, depression,

and other mental health issues, id. at 16. Researchers have found that this phenomenon

stems from “a perceived lack of control, treatment of other healthcare workers for

COVID-19, and uncertainty about colleagues’ infection status,” and it has been

accompanied by increased rates of resignation and retirement as well as incidents of

self-harm. Id. at 16–17 (citing Ari Schechter et al., Psychological Distress, Coping Behaviors,

and Preferences for Support among New York Healthcare Workers During the COVID-19

Pandemic, 66 Gen. Hosp. Psychiatry 1, 3 (2020), https://www.ncbi.nlm.nih.gov/pmc/

articles/PMC7297159, and Wendy Dean, Suicides of Two Health Care Workers Hint at the

COVID-19 Mental Health Crisis to Come, STAT News (Apr. 30, 2020),

https://www.statnews.com/2020/04/30/suicides-two-health-care-workers-hint-at-covid-

19-mental-health-crisis-to-come), 19 (citing Bridget Balch, “Worst Surge We’ve Seen”:

Some Hospitals in Delta Hot Spots Close to Breaking Point, AAMC (Aug. 24, 2021),

https://www.aamc.org/news-insights/worst-surge-we-ve-seen-some-hospitals-delta-

hot-spots-close-breaking-point).

Therefore, Plaintiffs have not demonstrated that “the balance of equities tips in

[their] favor.” Yang, 960 F.3d at 127. Because Section 2.61 furthers the State’s compelling

interest and Plaintiffs have not shown a likelihood of demonstrating that their

constitutional rights are violated by the Rule, they have also failed to show that a

preliminary injunction preventing the Rule’s implementation serves the public interest.

45
Whether this issue will ultimately carry any weight when the district courts decide

Plaintiffs’ entitlement to a permanent injunction on remand, we need not and do not

decide.

CONCLUSION

For the foregoing reasons, the order of the United States District Court for the

Eastern District of New York is AFFIRMED. The order of the United States District

Court for the Northern District of New York is REVERSED, and the preliminary

injunction entered by that court is VACATED. These tandem cases are REMANDED to

their respective district courts for further proceedings consistent with the Order entered

on October 29, 2021, and this Opinion.

46
 APPENDIX

Section 2.61. Prevention of COVID-19 transmission by covered entities

(a) Definitions.

(1) Covered entities for the purposes of this section, shall include:

(i) any facility or institution included in the definition of “hospital” in section
2801 of the Public Health Law, including but not limited to general hospitals,
nursing homes, and diagnostic and treatment centers;

(ii) any agency established pursuant to Article 36 of the Public Health Law,
including but not limited to certified home health agencies, long term home
health care programs, acquired immune deficiency syndrome (AIDS) home
care programs, licensed home care service agencies, and limited licensed home
care service agencies;

(iii) hospices as defined in section 4002 of the Public Health Law; and

(iv) adult care facility under the Department’s regulatory authority, as set forth
in Article 7 of the Social Services Law.

(2) Personnel, for the purposes of this section, shall mean all persons employed or
affiliated with a covered entity, whether paid or unpaid, including but not limited
to employees, members of the medical and nursing staff, contract staff, students,
and volunteers, who engage in activities such that if they were infected with
COVID-19, they could potentially expose other covered personnel, patients or
residents to the disease.

47
 (3) Fully vaccinated, for the purposes of this section, shall be determined by the
Department in accordance with applicable federal guidelines and
recommendations. Unless otherwise specified by the Department, documentation
of vaccination must include the manufacturer, lot number(s), date(s) of
vaccination; and vaccinator or vaccine clinic site, in one of the following formats:

(i) record prepared and signed by the licensed health practitioner who
administered the vaccine, which may include a CDC COVID-19 vaccine card;

(ii) an official record from one of the following, which may be accepted as
documentation of immunization without a health practitioner’s signature: a
foreign nation, NYS Countermeasure Data Management System (CDMS), the
NYS Immunization Information System (NYSIIS), City Immunization Registry
(CIR), a Department-recognized immunization registry of another state, or an
electronic health record system; or

(iii) any other documentation determined acceptable by the Department.

(c) [FN1] Covered entities shall continuously require personnel to be fully vaccinated
against COVID-19, with the first dose for current personnel received by September 27,
2021 for general hospitals and nursing homes, and by October 7, 2021 for all other covered
entities absent receipt of an exemption as allowed below. Documentation of such
vaccination shall be made in personnel records or other appropriate records in
accordance with applicable privacy laws, except as set forth in subdivision (d) of this
section.

(d) Exemptions. Personnel shall be exempt from the COVID-19 vaccination requirements
set forth in subdivision (c) of this section as follows:

(1) Medical exemption. If any licensed physician or certified nurse practitioner
certifies that immunization with COVID-19 vaccine is detrimental to the health of
member of a covered entity’s personnel, based upon a pre-existing health
condition, the requirements of this section relating to COVID-19 immunization
shall be inapplicable only until such immunization is found no longer to be

48
 detrimental to such personnel member’s health. The nature and duration of the
medical exemption must be stated in the personnel employment medical record,
or other appropriate record, and must be in accordance with generally accepted
medical standards, (see, for example, the recommendations of the Advisory
Committee on Immunization Practices of the U.S. Department of Health and
Human Services), and any reasonable accommodation may be granted and must
likewise be documented in such record. Covered entities shall document medical
exemptions in personnel records or other appropriate records in accordance with
applicable privacy laws by: (1) September 27, 2021 for general hospitals and
nursing homes; and (ii) October 7, 2021 for all other covered entities. For all
covered entities, documentation must occur continuously, as needed, following
the initial dates for compliance specified herein, including documentation of any
reasonable accommodation therefor.

(e) Upon the request of the Department, covered entities must report and submit
documentation, in a manner and format determined by the Department, for the
following:

(1) the number and percentage of personnel that have been vaccinated against
COVID-19;

(2) the number and percentage of personnel for which medical exemptions have
been granted;

(3) the total number of covered personnel.

(f) Covered entities shall develop and implement a policy and procedure to ensure
compliance with the provisions of this section and submit such documents to the
Department upon request.

(g) The Department may require all personnel, whether vaccinated or unvaccinated, to
wear an appropriate face covering for the setting in which such personnel are working in
a covered entity. Covered entities shall supply face coverings required by this section at
no cost to personnel.

49
Credits
Emergency rulemaking eff. Aug. 26, 2021, expires Nov. 23, 2021.
[FN1]
So in original.

Current with amendments included in the New York State Register, Volume XLIII, Issue
40 dated October 6, 2021. Some sections may be more current, see credits for details.

N.Y. Comp. Codes R. & Regs. tit. 10, § 2.61, 10 NY ADC 2.61

50