Roberts v. Bassett

UNITED STATES DISTRICT COURT

EASTERN DISTRICT OF NEW YORK

JONATHAN ROBERTS and CHARLES

VAVRUSKA, MEMORANDUM & ORDER

Plaintiffs, 22-CV-710 (NGG) (RML)

-against-

MARY T. BASSETT, in her official capacity as

Commissioner for NEW YORK STATE

DEPARTMENT OF HEALTH, and the

DEPARTMENT OF HEALTH AND MENTAL

HYGIENE OF THE CITY OF NEW YORK,

Defendants.

NICHOLAS G. GARAUFIS, United States District Judge.

Plaintiffs Jonathan Roberts and Charles Vavruska request that

this court issue a preliminary injunction to enjoin Mary T. Bas-

sett, the Commissioner of the New York State Department of

Health (the “State Defendant”) and the Department of Health

and Mental Hygiene of the City of New York (““DOHMH” or the

“City Defendant,” collectively, “Defendants”) from distributing

COVID-19 treatments on the basis of race. For the reasons ex-

plained below, this court lacks subject matter jurisdiction over

this dispute because Plaintiffs have not demonstrated Article I]

standing. Thus, as there is no case or controversy before this

court, the court declines to consider Plaintiffs’ motion for a pre-

liminary injunction, and the case is DISMISSED.

I. BACKGROUND

In December 2021, the Food and Drug Administration CFDA”)

issued Emergency Use Authorization (“EUA”) for several promis-

ing new oral antiviral therapies, including Paxlovid,

Molnupiravir, and Sotrovimab (the “Treatments”), to treat

COVID-19.! (State Def.’s Mem. in Opp. to Pl’s Mot. for Prelim.

Inj. at 2-3 (State’s Opp.) (Dkt. 22).) The FDA authorized the

Treatments for individuals “who are at high risk for progression

to severe COVID-19.”2 The EUA provides that “information on

medical conditions and factors associated with increased risk for

progression to severe COVID-19” can be found on the “People

with Certain Medical Conditions” page of the United States Cen-

ters for Disease Control and Prevention (“CDC”) website. 3

During the Omicron surge this winter, there were shortages of

the Treatments in New York. (PI’s Mem. in Supp. of. Mot. for

Prelim. Inj. at 1 (Mot.) (Dkt. 19); State’s Opp. at 3.) Given the

limited supply of the Treatments, on December 27, 2021, the

State Defendant and Gity Defendant published guidance for allo-

cating them.

The State’s guidance (“State Guidance”), which is addressed to

“Health Care Providers and Health Care Facilities,” informs pro-

viders that “[s]upplies of oral antivirals will be extremely limited

initially.” (Dec. 27, 2020 Mem. to Providers at 2 (Dkt. 1-4).) As

a result, “[w]hile supplies remain low,” providers are instructed

to “adhere to the NYS DOH guidance on prioritization” and “pri-

oritize therapies for people of any eligible age who are

moderately to severely immunccompromised regardless of vac-

cination status or who are age 65 and older and not fully

vaccinated with at least one risk factor for severe illness.” Ud.)

1 Sotromivab was the only authorized monoclonal antibody therapeutic

expected to be effective against the Omicron variant.

2 Food & Drug Admin., Emergency Use Authorization for Paxlovid (Dec.

22, 2021), https://www.fda.gov/media/155049/download; see also Food

& Drug Admin., Emergency Use Authorization for Molnupiravir (Feb. 4,

2022), https://www.fda.gov/media/155053/download; Food & Drug Ad-

min., Emergency Use Authorization for Sotrovimab (Feb. 23, 2022),

https://www fda.gov/media/149532/download; Food & Drug Admin.,

Frequently Asked Questions on the Emergency Use Authorization of Sotro-

vimab (Feb, 23, 2022), https://www.fda.gov/media/149535/download.

3 Ctrs, for Disease Control & Prevention, People With Certain Medical Con-

ditions (Feb. 25, 2022), https://Awww.cdc.gov/coronavirus/2019-

ncov/need-extra-precautions/people-with-medical-conditions.html.

The State Guidance provides that the Treatments are authorized

for patients who (i) are twelve or older, (ii) test positive for

COVID-19, (iii) have mild to moderate symptoms, (iv) are able

to start treatment within five days of symptom onset, and (vy)

have a medical condition or other factors that increase risk for

severe illness. (id. at 3.) With respect to risk factors, the State

Guidance explains that “[n]on-white or Hispanic/Latino ethnic-

ity should be considered a risk factor, as longstanding systemic

health and social inequities have contributed to an increased risk

of severe illness and death from COVID-19.” Cd.)

The State Guidance also includes a table that delineates how to

prioritize distribution of the Treatments during “times of re-

source limitations.” (Prioritization Guidance at 2 (Dkt. 1-5).) The

table creates risk groups based on vaccination, age, immunocom-

promised status, and a number of “risk factors for severe illness.”

(id, at 3.) The Guidance provides a recommended approach and

notes of prioritization for each risk group. At issue here is a note

that provides that “[n]on-white race or Hispanic/Latino ethnicity

should be considered a risk factor, as longstanding systemic

health and social inequities have contributed to an increased risk

of severe illness and death from COVID-19.” (Id. at 4.) Though

the guidance does not explicitly define “risk factors for severe ill-

ness,” it cites to the same CDC webpage with risk factors

referenced in the FDA’s FUAs. Ud.) Those federal risk factors in-

clude “racial and ethnic minority groups.”

On March 4, 2022, the State Defendant issued new guidance,

which advises that the Treatments are now “widely available”

and that the federal government’s Test to Treat program, which

began the week of March 7, 2022, “will provide increased avail-

ability of immediate testing and early treatment.” (Mar. 4, 2022

State Guidance (Dkt. 31-1).)

The City’s Health Advisory #39 (the “City Guidance”) directs

health care providers to “adhere to the New York State Depart-

ment of Health... guidance on prioritization of high-risk

patients . . . during this time of severe resource limitations.”

(Health Advisory #39 at 2 (Dkt. 1-6).) The City Guidance reiter-

ates the eligibility criteria from the State Guidance and adds:

“Consider race and ethnicity when assessing an individual's risk.

Impacts of longstanding systemic health and social inequities put

Black, Indigenous, and People of Color at increased risk of severe

COVID-19 outcomes and death.” Ud. at 4.)

On February 1, 2022, the City Defendant issued Health Advisory

#2, which superseded the challenged guidance. (March 2, 2022

Tr. 32:16-23.) The new advisory notes that the treatments are in

stock, but that “supplies remain limited.”*

Plaintiff Jonathan Roberts is a vaccinated 61-year-old non-His-

panic and white resident of Manhattan with no known risk

factors; his co-Plaintiff Charles Vavruska is a vaccinated 55-year-

old non-Hispanic and white resident of Queens, and is over-

weight or obese, which is considered a risk factor. (Mot. at 6.)

Plaintiffs assert that they are entitled to access to the ‘Treatments

on an equal basis, without regard to their race. Roberts, who does

not meet the eligibility requirements, contends that he is entirely

denied access to the drugs. Cd. at 8.)

Plaintiffs allege that this scheme makes race determinative in two

ways. First, among members in the same risk group, individuals

who ate non-white or Hispanic receive higher priority for treat-

ment over those who are of the same age and have the same race-

neutral risk factors. (id. at 4.) Second, being a member of any

minority group could move an individual to a higher risk group.

(id.) On this basis, Plaintiffs contend that Defendants have vio-

lated the equal protection clause of the Fourteen Amendment in

issuing the challenged guidance.

Defendants assert that the directives are merely guidance to be

used in emergency periods of limited supplies and do not sup-

plant the judgment of a medical provider. (State’s Opp. at 3.)

4N.Y.C, Dep’t of Health & Mental Hygiene, Health Advisory #2: Paxlovid is

Available for COVID-19 Treatment in New York City (Feb. 1, 2022),

https://www1 nyc. □□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□

sory/2022/covid-paxlovid-available.pdf.

They argue the guidance “simply provides medical practitioners

with information about known risk factors for severe illness, hos-

pitalization, and death, based on abundantly reported, objective,

data.” (Id, at 6.) Although Plaintiffs state that Roberts is categor-

ically ineligible for the medication, Defendants maintain that

“(nJothing in the . . . Guidance prevents the Plaintiffs . . . from

receiving the Therapies . . . if their practitioner concludes that

such treatment is clinically appropriate.” (Id.)

Defendants further contend that there is no longer a shortage of

the Treatments, and the guidance applied only “during [a past]

time of severe resource limitations.” (Id. at 16.) Plaintiffs counter

that providers frequently report low stock and, given the unpre-

dictability of the COVID-19 pandemic and the likelihood of future

variants, a future shortage is not unlikely. (Mot. at 7, 9.)

On February 18, 2022, Plaintiffs moved for a preliminary injunc-

tion, seeking to enjoin Defendants from distributing the

Treatments in accordance with the above guidance.

Il. LEGAL STANDARD

“It is axiomatic that federal courts are courts of limited jurisdic-

tion and may not decide cases over which they lack subject

matter jurisdiction,” Lyndonville Sav. Bank & Tr. v. Lussier, 211

F.3d 697, 700 (2d Cir. 2000), and “standing is perhaps the most

important of the jurisdictional doctrines.” FW/PBS, Inc. v. City of

Dallas, 493 U.S. 215, 231 (1990).° If a court does not have sub-

ject matter jurisdiction, the action must be dismissed. Fed. R. Civ.

P. 12(h)(3); Cave v. E. Meadow Union Free Sch. Dist., 514 F.3d

240, 251 (2d Cir. 2008) (“Appellants’ motion for a preliminary

injunction should therefore have been dismissed for lack of juris-

diction, rather than on the ground that appellants are unlikely to

succeed on the merits of their action.”). The party “invoking the

authority of the court bears the burden of proof on the issue of

5 When quoting cases, and unless otherwise noted, all citations and quota-

tion marks are omitted, and all alterations are adopted.

standing.” Lee v. Bd. of Governors of the Fed. Reserve Sys., 118 F.3d

905, 910 (2d Cir. 1997).

To establish Article III standing, a plaintiff must show (1) an in-

jury in fact, which is (a) concrete and particularized, and (b)

actual or imminent, not conjectural or hypothetical; (2) that the

injury is fairly traceable to the challenged action of the defend-

ant; and (3) that it is likely the injury will be redressed by a

favorable decision. Lujan v. Defenders of Wildlife, 504 U.S. 555,

560-61 (1992).

Iii, DISCUSSION

A. Article Ill Standing

1. Injury in Fact

There are two components to establishing an “injury in fact.”

First, a plaintiff must show that the harm was concrete and par-

ticularized; and second, a plaintiff must show that the harm was

actual or imminent. See id. at 560.

a. Concrete and Particularized

The parties submit that in the equal protection context, the injury

in fact “is the denial of equal treatment resulting from the impo-

sition of [a] barrier,” which “makes it more difficult for members

of one group to obtain a benefit than it is for members of another

group.” Ne. Fla, Chap. of Assoc. Gen. Contractors of Am. v. City of

Jacksonville, 508 U.S. 656, 666 (1993). The injury is not “the ul-

timate inability to obtain the benefit.” Id. The Second Circuit has

set forth the following criteria for establishing standing under the

“barrier” standard, that: “(1) there exists a reasonable likelihood

that the plaintiff is in the disadvantaged group, (2) there exists a

government-erected barrier, and (3) the barrier causes members

of one group to be treated differently from members of the other

group.” Comer v. Cisneros, 37 F.3d 775, 793 (2d Cir. 1994).

The court accepts that to the extent there is a group that is “dis-

advantaged” by Defendants’ guidance, there is a reasonable

likelihood that Plaintiffs, as white and non-Hispanic individuals,

are members of the group. But the court is not convinced that

Plaintiffs have shown the challenged guidance either constitutes

a barrier or causes one group to be treated differently from an-

other.

b. Existence of a Government-Erected Barrier

The “barrier” concept described in City of Jacksonville has its roots

in Regents of University of California v. Bakke, in which the Su-

Supreme Court explained that, in the affirmative action context,

a plaintiffs injury was his inability “to compete for all 100 places

in the class.” 438 U.S. 265, 280 n.14 (1978). The impetus behind

this standard was to save those plaintiffs from having to affirma-

tively show that they would have obtained the benefit but for the

barrier—in Bakke, that the applicant would have otherwise been

admitted to medical school, However, the barrier standard does

not dispense with the Article III injury requirement; a policy or

program is only a “barrier” if it denies plaintiffs equal treatment

in some manner.

In Bakke and City of Jacksonville, the Court found that a barrier

existed because the policies at issue set aside a predetermined

number of spots or amount of funding for individuals from un-

derrepresented groups; in effect, they created quotas. See City of

Jacksonville, 508 U.S. at 658 (10% of amount spent on city con-

tracts set aside for “Minority Business Enterprises”); Bakke, 438

U.S. at 266 (16 out of 100 places in the medical school class re-

served for “minority” students). Thus, these barriers denied

plaintiffs equal treatment because fewer spots or less funding

were accessible to them than a similarly situated underrepre-

sented candidate. ~

The Court has explicitly employed the barrier approach to stand-

ing on only a few occasions in majority opinions since City of

Jacksonville. First, in Adarand Constructors, Inc. v. Pena, a subcon-

tractor alleged racial discrimination stemming from a

government program, which provided compensation to contrac-

tors if they hired small businesses controlled by “socially and

economically disadvantaged individuals,” defined as “Black

Americans, Hispanic Americans, Native Americans, Asian Pacific

Americans, and other minorities, or any other individual found

to be disadvantaged by the Small Business Administration.” 515

U.S. 200, 205 (1995).° The Court found that the plaintiff had

standing to seek prospective relief because the “discriminatory

classification prevents the plaintiff from competing on an equal

footing.” Id. at 211. Like the City of Jacksonville scheme, which

rendered a pot of funds accessible to underrepresented candi-

dates but entirely inaccessible to the plaintiffs, the government

program in Adarand awarded funds only to members of disad-

vantaged groups.

A decade after City of Jacksonville, in Gratz v. Bollinger, the Court

revisited the barrier standard. 539 U.S. 244 (2003).’ The rele-

vant University of Michigan admission policy provided that

“underrepresented minority freshman applicants receive 20

points” of the 100 points needed to guarantee admission. Id. at

6 Other regulations provided for the inclusion of women and other socially

or economically disadvantaged individuals in this program. See id. at 208.

? Plaintiffs note Gratz’s companion case, Grutter v. Bollinger, as support for

their conception of standing in the context of the equal protection clause.

539 U.S. 306 (2003). In Grutter, the Court noted that the plaintiff “clearly

has standing” and cited Gity of Jacksonville, but it neither mentioned the

barrier standard nor provided further analysis, and standing was not ad-

dressed in by the lower court decisions. Id. at 317. Without more from the

Court, it is difficult to know whether the decision to find standing rested

on the barrier standard or some other standard and why the Court deter-

mined there was standing. Undoubtedly, the permissible race-conscious

law school admissions policy in Grutter is more similar to the challenged

guidance in this case than the other barrier cases that the Court has con-

sidered. Still, the court is not troubled by any apparent similarities in the

nature of the barrier. Even if the challenged guidance did constitute a “bar-

rier,” Plaintiffs’ claim is neither concrete and particularized nor actual or

imminent, whereas Grutter’s injury clearly was: She had personally been

rejected from the University of Michigan Law School and sought, among

other relief, compensatory and punitive (rather than nominal) damages in

addition to an order requiring the institution to offer her, personally, ad-

mission. See id.

266.° This undergraduate admission policy was similar to the

scheme in Adarand in that 20 points, or 20% of the total points

needed to gain admittance, were offered only to underrepre-

sented minorities. Because the points were completely

unavailable to applicants who were not underrepresented minor-

ities, the Court held that plaintiffs were denied equal treatment

in the admissions process.

Finally, in Parents Involved in Community Schools v. Seattle School

District 1, the Court again alluded to City of Jacksonville’s barrier

standard in holding that “being forced to compete in a race-based

system that may prejudice the plaintiff’ can constitute an equal

protection injury. 551 U.S. 701, 719 (2007). The scheme in Par-

ents Involved classified children based on their race, which the

school districts “relie[d] upon . . . in assigning [the] student to a

particular school, so that the racial balance at the school [fell]

within a predetermined range based on the racial composition of

the school district as a whole.” Id. at 709. In effect, the school

district again had created racial quotas along the lines of the

8 The standing analysis was complicated in this case because the class rep-

resentative, after being rejected from the University of Michigan, alleged

in the complaint that he intended to transfer if the “discriminatory” admis-

sions policy was eliminated. Gratz, 539 U.S. at 283 (Stevens, J.,

dissenting). But the transfer policy, which the Court summarized as “all

minimally qualified minority transfer applicants [we]re admitted out-

tight,” id. at 266, was not before the Court. (Nor was it discussed in the

lower court opinions). The Court found that the transfer student had stand-

ing to request prospective relief as it related to the undergraduate policy

because it was so similar to the transfer policy. Jd. (explaining that the sole

differences between the two processes were the fact that the freshman pro-

gram used the 20-point system, whereas “virtually all . . . minimally

qualified” underrepresented transfer students were admitted). Thus, the

fact that the class representative was a transfer student seeking prospective

relief as it related to the undergraduate admissions policy “clearly ha[d]

no effect on petitioners’ standing to challenge the University’s use of race

in undergraduate admissions.” Id. While the Court’s barrier analysis fo-

cused more on the actual or imminent prong, it is clear that the barrier for

standing purposes was the undergraduate admission policy, not the trans-

fer policy.

scheme challenged in Bakke, making certain spots completely un-

available to white students, thus denying them equal treatment.

This review of the Court’s racial discrimination jurisprudence un-

der the barrier standard makes clear that the types of policies and

programs previously found to be barriers are different than the

State and City Guidance at issue in this case. Here, the guidance

does not set aside a predetermined number of pills for nonwhite

and Hispanic New Yorkers. The guidance does not advise provid-

ers to automatically dispense pills to nonwhite and Hispanic

patients on the basis of race or ethnicity. Nor does it set a thresh-

old—or even target—number of points in order to obtain the

Treatments or give some predetermined percentage of such

points to nonwhite and Hispanic patients. It is, rather and em-

phatically, guidance. Defendants’ documents are nonbinding and

have no mechanism for present or future enforcement. The guid-

ance merely advises providers to consider race and ethnicity as

one of many factors in assessing the patient before them, con-

sistent with medical evidence and with the limited FDA EUAs for

the Treatments. Nor are medical practitioners akin to educational

institutions or governmental agencies reviewing a total set of ap-

plicants and comparing them to one another to determine who

qualifies for a benefit. Instead, individual practitioners, third par-

ties otherwise unconnected to Defendants, make individualized

assessments of each of their own patients and decide on an ap-

propriate course of treatment. The court is skeptical that the

injury alleged here constitutes a barrier under the Supreme

Court’s previous decisions given these important distinctions.

However, even if it did, City of Jacksonville emphasizes the im-

portance of finding that a barrier impacted the plaintiffs

personally, and as discussed in the following sections, Plaintiffs

have alleged neither a concrete and particularized nor actual or

imminent injury.

10

c. Impact of the Alleged Barrier on Different Groups

As to the third element set forth in Cisneros, Plaintiffs also must

show that the challenged guidance causes them to be treated dif-

ferently than members of other groups. But Plaintiffs fail to show

that their injury is anything more than a generalized grievance.

Although the court acknowledges that the injury in fact require-

ment “is not as stringent in Equal Protection cases, a plaintiff still

must establish that she has suffered some sort of identifiable

harm.” Youth Alive v. Hauppauge Sch. Dist., No. 08-CV-1068

(NGG) (VMS), 2012 WL 4891561, at *2 (E.D.N.Y. Oct. 15,

2012). This is particularly true in light of the Supreme Court’s

recent decision in Spokeo v. Robins, which emphasized the “con-

creteness” and “particularization” elements of an injury in fact.

As Justice Alito explained for the Court, an injury “must affect

the plaintiff in a personal and individual way” and must also be

concrete, “that is, it must actually exist.” 578 U.S. 330, 339-340

(2016). Thus, for example, the Court has declined to find stand-

ing where plaintiffs alleged an injury based on the IRS’s grant of

a tax-exemption to a racially discriminatory school. See Allen v.

Wright, 468 U.S. 737, 755-56 (1984). The court explained that

there had been merely an “abstract stigmatic injury,” and were

the court to permit plaintiffs to proceed on that basis, “[a] black

person in Hawaii could challenge the grant of a tax exemption

to a racially discriminatory school in Maine.” Id. at 756.

Consistent with this requirement, the Court has “refused to rec-

ognize a generalized grievance against allegedly illegal

governmental conduct as sufficient for standing.” United States

v. Hays, 515 U.S, 737, 743 (1995). This rule that generalized

grievances cannot satisfy Article III standing “applies with as

much force in the equal protection context as in any other.” Id.

Where the government allegedly discriminates on the basis of

race, “the resulting injury accords a basis for standing only to

those persons who are personally denied equal treatment by the

challenged discriminatory conduct.” Id. at 743-744 (emphasis

added); see also Carney v. Adams, 141 S.Ct. 493, 502 (2020)

11

(“[Plaintiff] has not sufficiently differentiated himself from a gen-

eral population of individuals affected in the abstract by the legal

provision he attacks.”). In accordance with the Court’s general-

ized grievance jurisprudence, courts in this district applying the

barrier standard have looked for some type of identifiable harm.

See, e.g., Evans v. Port Auth. of N.Y. & N.J., 15-CV-3942 (MKB),

2017 WL 3396444, at *5-6 (E.D.N.Y. Aug. 8, 2017) (holding that

plaintiffs did not show “that they have been injured in a personal

and individual way” where employing the barrier standard);

Credico v. N.Y. State Bd. of Elections, No. 10-CV-4555 (RJD)

(CLP), 2013 WL 3990784, at *8-*9 (E.D.N.Y. Aug. 5, 2013) (an-

alyzing whether the alleged barrier imposed a concrete injury on

plaintiffs); Youth Alive, 2012 WL 4891561, at *3 (finding that the

the challenged practice “had no discernible impact on Plaintiffs’

ability to exercise their First Amendment rights”).

Plaintiffs have not explained how nonbinding guidance that di-

rects medical practitioners to consider race and ethnicity as one

factor in prescribing the Treatments impacts them in some con-

crete and particularized manner. Plaintiffs never contracted

COVID-19 nor sought out the Treatments during the period of

shortage. Plaintiffs have proffered no evidence beyond the mere

existence of the nonbinding guidance to demonstrate that Plain-

tiffs or any other white, non-Hispanic person (who, in any event,

is not before this court) have faced a barrier “that actually exists”

to obtaining the Treatments on the basis of their race. Plaintiffs

have not even alleged that during the period of shortage that any

person whatsoever was denied the Treatments. This action, then,

“resembles a complaint asserting that the plaintiffs chances of

winning the lottery were reduced, filed by a plaintiff who never

bought a lottery ticket, or who tore it up before the winner was

announced.” Clinton v. City of N.Y., 524 U.S. 417, 458 (1998)

(Scalia, J., concurring). Indeed, it is not clear the lottery ever took

place.

At this stage, any “injury” is, at most, the type of “abstract stig-

matic harm” that the Court rejected in Allen. That conclusion is

buttressed by Plaintiffs’ request for only nominal damages. If the

court were to accept this conception of an injury in fact, it would

13

be opening its doors to the type of generalized grievances that

“transform the federal courts into no more than a vehicle for the

vindication of the value interests of concerned bystanders.” Allen,

468 U.S. at 756. It would be permitting millions of not-yet-in-

jured New Yorkers to sue Defendants.

Without evidence of the impact of this alleged barrier in practice

and how it has denied these particular Plaintiffs equal treatment,

the court is unable to find that this injury is sufficiently concrete

or particularized to constitute an Article III injury.

d. Actual or Imminent

Even if this court were to find that Plaintiffs’ alleged barrier was

sufficiently concrete and particularized, the injury must also be

actual or imminent to constitute an injury in fact. See Lujan, 504

U.S. at 560. Plaintiffs are not permitted to rely on a “speculative

chain of possibilities,” particularly where they involve “the unfet-

tered choices made by independent actors not before the court.”

Clapper v. Amnesty Intl USA, 568 U.S. 398, 414 & n.5 (2013).

Instead, the injury must be “certainly impending.” Id. at 410.

Plaintiffs appear to argue that somehow the Court’s holding in

Clapper cannot apply in the equal protection context, because the

injury “is not the ultimate denial of the treatments, but the gov-

ernment-imposed barriers to obtaining those treatments.” (Pl.’s

Reply in Supp. of Mot for Prelim. Inj. at 5 (“Reply”) (Dkt. 27).)

But even in barrier cases, courts must still inquire into whether

the injury is “imminent” or “certainly impending.” MGM Resorts

Int’t Glob. Gaming Dev., LLC v. Malloy, 861 F.3d 40, 46-47 (2d

Cir. 2017).

In City of Jacksonville, the Court found that the barrier injury was

sufficiently actual or imminent where plaintiffs “regularly bid on

contracts in Jacksonville and would bid on those that the city’s

ordinance makes unavailable to them.” 508 U.S. at 668. Like-

wise, in Adarand, the Court accepted the imminence of the injury

because the plaintiffs general manager testified that the com-

pany had bid on every guardrail project in the state. 515 U.S. at

212. Conversely, the Second Circuit did not find imminence

13

where a plaintiff was merely “interested” in exploring an oppor-

tunity and “made initial studies of . . . viability.” Malloy, 861 F.3d

at 47. This is because the competition was “purely abstract,” and

there was not yet an “uneven playing field.” Id. at 51; see also

Carney, 141 S.Ct. at 501-03 (contrasting the plaintiffs “few

words of general intent” about applying for a judgeship with

“similar cases . . . contain[ing] more evidence that the plaintiff

was ‘able and ready” to apply, including Adarand, City of Jack-

sonville, and Gratz), The lesson from these cases is plain: A

plaintiff is not injured by the mere existence of a barrier denying

equal treatment, but must also show that the barrier threatens to

wreak harm that is actual or imminent to them. Unlike the plain-

tiffs in the Supreme Court’s barrier cases, Plaintiffs’ attempts here

to “compete” for the benefit of the Treatments are “still entirely

conjectural.” Malloy, 861 F.3d at 51.

With respect to Plaintiffs’ request for prospective relief, the court

agrees with Plaintiffs that it is impractical to wait until a person

has tested positive for COVID-19 to file suit challenging the guid-

ance. (Mot. at 9.) But in order to justify injunctive relief, even

assuming they were injured in the past, Plaintiffs must at very

least be able to establish a likelihood they will be subject to the

same treatment in the future. See City of Los Angeles v. Lyons, 461

U.S. 95, 111 (1983). In this period of surplus, however, the State

Guidance is not in effect, and the City Guidance has been super-

seded, Although Plaintiffs argue that a future shortage is likely in

light of the unpredictability of the COVID-19 virus and possible

variants, a possibility the court acknowledges, the federal gov-

ernment has announced that Pfizer alone—the manufacturer of

only one of the three Treatments—will provide “1 Million pills

this month and more than double that next month.” At this rate

? The White House, Remarks of President Joe Biden ~ State of the Union

Address As Prepared for Delivery (Mar. 1, 2022),

https://www.whitehouse.gov/briefing-room/speeches-re-

marks/2022/03/01/remarks-of-president-joe-biden-state-of-the-union-

address-as-delivered/; see also Press Release, Pfizer to Provide U.S. Govern-

ment with an Additional 10 Million Treatment Courses of its Oral Therapy to

14

of production, as compared to the current COVID-19 case counts,

the possibility of a future shortage appears increasingly specula-

tive and nowhere near imminent. Further, there is no indication

that future variants will be responsive to the Treatments. There

would at least have to be a future shortage; the State Guidance

would have to come back into effect; and the City would have to

issue new guidance using race and ethnicity in a similar manner

to the superseded guidance. None of these events are imminent.

Turning to Plaintiffs’ request for retrospective relief for the period

in which the challenged guidance was in place, to incur even

nominal damages, the Plaintiffs would have had to actually run

up against the alleged barrier and experience a denial of equal

treatment. See City of Jacksonville, 508 U.S. at 666 (injury is “the

denial of equal treatment resulting from the imposition of the bar-

rier’ (emphasis added)). First, Plaintiffs, who are both

vaccinated, would have needed to contract COVID-19. Second,

they would have needed to seek out the Treatments from a med-

ical provider. Third, the medical provider would have needed to

rely on the nonbinding guidance to determine whether to pre-

scribe the Treatments. Fourth, and finally, that provider would

have needed to apply the guidance in such a manner so as to

deny Plaintiffs equal treatment. This requisite chain of events

demonstrates that Plaintiffs’ allegation of injury is “too specula-

tive to satisfy the well-established requirement that threatened

injury must be certainly impending.” See Clapper, 568 U.S. at

401. Plaintiffs have not yet come anywhere close to arriving at

the “imeven playing field,” let alone attempted to compete on it.

Malloy, 861 F.3d at 51. This is not to say that Plaintiffs would

have to show they had laced up for a game they were destined

to lose, but the game itself would have had to at least been

Help Combat COVID-19 (Jan. 4, 2022),

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-

provide-us-government-additional-10-million (announcing that Pfizer will

supply the federal government with 20 million Paxlovid treatment courses,

half of which will be delivered by the end of June 2022).

15

played. Because it never was, Plaintiffs fail to allege an injury that

is actual or imminent.

Since Plaintiffs fail to allege an injury that is concrete and partic-

ularized and actual or imminent, Plaintiffs cannot satisfy the

injury in fact requirement. Accordingly, the court finds that Plain-

tiffs lack standing on this ground.

2. Traceability

Even assuming Plaintiffs could establish an injury in fact, they

would need to establish traceability—that there be a “causal con-

nection between the injury and the conduct complained of,”

which should not be “the result of the independent action of

some third party not before the court.” Lujan, 504 U.S. at 560.

The “line of causation” between the allegedly unconstitutional

conduct and the plaintiffs injury may not be “too attenuated.”

Allen, 468 U.S. at 752, 759; see also Simon v. E. Kentucky Welfare

Rights Org., 426 U.S. 26, 42-43 (1976) (“It is purely speculative

whether the denials of service specified in the complaint fairly

can be traced to [IRS] ‘encouragement? or instead result from de-

cisions made by the hospitals without regard to the tax

implications.”). Although a plaintiff “need not allege that a de-

fendant’s challenged actions were the very last step in a chain of

events leading to an alleged injury,” they must at least “plead

facts indicating that a defendant’s actions had a determinative or

coercive effect upon the action of someone else who directly

caused the alleged injury.” Natl Council of La Raza v. Mukasey,

283 F. App’x 848, 851 (2d Cir. 2008) (summary order) (citing

Bennett vy. Spear, 520 U.S. 154 (1997)). In La Raza, the Second

Circuit found that the federal government’s policy and practice

of entering civil immigration records into criminal records data-

bases, which were then accessible by state and local law

enforcement agencies, was not sufficiently “determinative or co-

ercive” where no “adverse consequences” resulted from

resistance to the policy. Id. at 852. In reaching this decision, the

La Raza panel distinguished the Supreme Court’s decision in Ben-

net, 520 U.S. at 170, where a Fish and Wildlife Services opinion

16

by contrast could result in “substantial civil and criminal penal-

ties.” Id.

Because the injury alleged here is unequal treatment as a result

of the nonbinding guidance, the hypothetical injury occurs at the

point that medical practitioners make decisions in reliance on the

guidance. The traceability question—insofar as the injury traces

back to Defendants—then hinges upon whether the challenged

guidance had a “determinative or coercive effect” upon medical

practitioners. Plaintiffs contend that even if the challenged guid-

ance “do[es] not expressly provide for a penalty... the Supreme

Court ‘appears willing to presume that the government will en-

force the law as long as the relevant statute is recent and not

moribund.” (Mot. at 10 (quoting Hedges v. Obama, 724 F.3d 170,

197 (2d Cir. 2013)).) While conceding that the injury may also

be attributable to providers, Plaintiffs maintain that the injury is

still “fairly traceable” to Defendants. (id.) In response, State De-

fendant explains that practitioners make independent

judgments, so any hypothetical scenario in which Plaintiffs were

unable to get a prescription for the Treatments would not be

traceable to the challenged guidance. (State Opp. at 15.) Plain-

tiffs counter that the State “cannot blame physicians or

practitioners if they follow the government-created guidance.”

(Reply at 5.)

Hedges, however, describes the Court’s approach to pre-enforce-

ment challenges to laws. This case, by contrast, challenges

nonbinding guidance, not law, and it does not do so in a pre-

enforcement posture. The court is therefore unwilling to pre-

sume, as in Hedges, that a law is likely to soon be enforced when

it is not even clear whether the challenged guidance ever will be,

or ever can be. Indeed, there are no penalties for failure to abide

by the guidance, nor is there any enforcement mechanism in

place. Given that practitioners ultimately impose any alleged de-

nial of equal treatment, and the nonbinding guidance has no

“determinative or coercive effect” on these practitioners, the

court finds that Plaintiffs lack standing on this alternative

ground.

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3. Redressability

The final element of standing is redressability. Plaintiffs must

show that it is “likely, as opposed to merely speculative, that the

injury will be redressed by a favorable decision.” Lujan, 504 U.S.

at 561. The Supreme Court has distinguished between redressa-

bility in the context of “identifiable Government violations of

law” and lawsuits “challeg[ing] a more generalized level of Gov-

ernment action.” Id, at 568 (distinguishing between challenging

“decisions to fund particular projects allegedly causing [plain-

tiffs] harm” and an agency regulation). Where, as here, plaintiffs

elect to challenge the latter, the Court has expressed that “[s]uch

suits, even when premised on allegations of several instances of

violations of law, are rarely if ever appropriate for federal-court

adjudication.” Allen, 468 U.S. at 759-60. This is particularly true

in cases where the individual or entity directly inflicting the in-

jury, ie. the medical provider, is not a party. The court can

“accord relief only against” parties to the suit. Lujan, 504 U.S. at

568.

Courts in the Second Circuit have put the onus on Plaintiffs to

show that withdrawing guidance impacting third parties would

redress their injuries. In Town of Babylon v. Federal Housing Fi-

nance Agency, the Town of Babylon and the National Resources

Defense Council alleged that a Federal Housing Finance Agency

directive and Office of Comptroller of the Currency (“OCC”) bul-

letin adversely impacted certain clean energy programs. 699 F.3d

221, 224 (2d Cir. 2012). The court assessed whether plaintiffs

had standing to challenge the OCC Bulletin for allegedly altering

the lending practices of national banks, which were not party to

the litigation. Id. at 229-30. Focusing on the fact that “[n]othing

in the OCC Bulletin compelled national banks to take any action,”

and that it was “Supervisory Guidance,” the court found that

plaintiffs failed to show that the “national banks regulated by the

OCC would act differently were the OCC Bulletin vacated.” Id.

Lower courts in the Second Circuit have taken a similar ap-

proach. See, eg., Doe v. U.S. Sec’y of Transp., No. 17-CV-7868

(CS), 2018 WL 6411277, at *6 (S.D.N.Y. Dec. 4, 2018) (“Plain-

tiffs .. . allege that airlines and hotels have explained that they _

18

are required to allow dogs on their premises due to federal regu-

lations, but that does not equate to an allegation that, absent the

regulations, the regulated entities would exclude service ani-

mals.”); Town of Southold v. Town of E. Hampton, 406 F. Supp.

2d 227, 236 (E.D.N.Y. 2005) (“Since ferry operators rather than

the Town Plaintiffs are the objects of the Ferry Law, and the

Town Plaintiffs can show neither that the Ferry Law caused their

alleged injury nor that these alleged injuries would be redressed

by a favorable decision, they do not satisfy the Article III standing

requirements.”), affd & rev'd on other grounds, 477 F.3d 38, 46

(2d Cir. 2007).

Here, Plaintiffs challenge broad nonbinding guidance rather than

an “identifiable Government violation of the law.” See Lujan, 504

U.S. at 568. The “regulated parties” under the guidance are med-

ical providers in New York who implement the guidance and

thereby inflict the alleged injury. These providers are not before

this court, and as a result, the court is not able to control their

activities. Thus, Plaintiffs must show the court that providers

would behave differently in the absence of the guidance. Plain-

tiffs have not done so.

Moreover, as the State Defendant has pointed out, in the absence

of the State and City guidance, many elements of the guidance

would certainly remain in place. Cf. Town of Babylon, 699 F.3d at

230. Based on the court’s understanding of the FDA’s EUAs,

Plaintiff Roberts would be in the exact same situation in the ab-

sence of the guidance. The EUAs for the Treatments are limited

to individuals with a high risk of developing severe COVID-19, as

defined by the CDC’s risk factors. Roberts alleges that he has

none of these risk factors. (Compl. { 39.) Thus, with or without

this policy, Roberts faces a complete barrier to obtaining the

Treatments. Even if he were eligible under the EUAs, Plaintiffs

have not alleged how practitioners would act in the absence of

the guidance. They allege that the “CDC Guidance does not em-

ploy race in the same way as the directives” without explaining

further. (Reply at 5.) As the court sees it, though, the EUAs di-

rectly point providers to the CDC risk factors, which themselves

include the consideration of race and ethnicity. Providers could

19

be expected to follow the CDC guidance and other available sci-

entific and medical research about the nature of race and

ethnicity as risk factors. Thus, it is not clear that they would be-

have differently in the absence of the challenged guidance.

Plaintiffs have not shown it is likely that that their injuries will be

redressed by a favorable decision. Thus, the court finds yet an-

other reason that they do not have standing.

IV. CONCLUSION

For the reasons explained above, all claims against Defendants

are DISMISSED without prejudice.

SO ORDERED.

Dated: Brooklyn, New York

March IS, 2022

s/Nicholas G. Garaufis

NICHOLAS G. GARAUFIS.

United States District Judge

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