Lisa Hill Leonard v. The Alabama State Board of Pharmacy

USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 1 of 25

[PUBLISH]

In the

United States Court of Appeals

For the Eleventh Circuit

____________________

No. 22-11124

____________________

LISA HILL LEONARD,

An individual,

LEONARD DRUGS INC,

An Alabama Corporation d.b.a. The Drug Store,

Plaintiffs-Appellants,

versus

THE ALABAMA STATE BOARD OF PHARMACY,

A State Licensing Board,

BRENDA DENSON,

CHRIS PHUNG,

ROBERT COLBURN,

CHRISTY K. GARMON,

GARY MOUNT,

Individually and in their official capacities as Members

USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 2 of 25

2 Opinion of the Court 22-11124

of the Alabama State Board of Pharmacy,

Defendants-Appellees.

____________________

Appeal from the United States District Court

for the Middle District of Alabama

D.C. Docket No. 3:21-cv-00596-ECM-SMD

____________________

Before WILSON, JILL PRYOR, Circuit Judges, and RUIZ, * District

Judge.

WILSON, Circuit Judge:

In the early days of the Covid-19 pandemic, both State and

Federal governments partnered with private citizens and busi-

nesses to “Stop the Spread” of the virus. The government invested

billions of dollars in the research, development, and production of

tests to detect existing infections and vaccines to arrest the preva-

lence of future infections. Thousands of businesses, schools, hos-

pitals, and community organizations across the nation mobilized

to distribute tests and vaccines to millions of people. To encourage

voluntary participation in the distribution of these

*Honorable Rodolfo A. Ruiz II, United States District Judge for the Southern

District of Florida, sitting by designation.

USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 3 of 25

22-11124 Opinion of the Court 3

countermeasures, the Secretary of Health and Human Services

(HHS) invoked the Public Readiness and Emergency Preparedness

Act (PREP Act), to provide legal immunity for the individuals and

organizations who provided these countermeasures to the public.

Based in Auburn, Alabama, Lisa Leonard and her pharmacy

were one of the thousands of businesses who answered the call to

provide Covid-19 tests to the public. However, the Alabama Board

of Pharmacy (the Board) concluded that Leonard’s administration

of these tests fell short of the medical safety standards required un-

der Alabama law. When the Board instituted an administrative en-

forcement proceeding against Leonard, she sought to avail herself

of the legal immunity provided by the Secretary’s PREP Act Dec-

laration. Leonard filed this federal suit, seeking to enjoin the Board

from even considering the charges against her. The district court

exercised its discretion to abstain under Younger v. Harris, 401 U.S.

37 (1971) and declined to intervene in the Board’s proceedings.

This appeal followed.

After careful review of the record, and with the benefit of

oral argument, we affirm the district court’s decision to abstain un-

der Younger. Leonard and her business have an adequate oppor-

tunity to raise their federal immunity argument before the Board,

and none of the exceptions to Younger abstention apply in this

case.

USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 4 of 25

4 Opinion of the Court 22-11124

I. Background

A.

On January 31, 2020, the Secretary of HHS declared a public

health emergency in the United States following the outbreak of

the Covid-19 pandemic. Two months later, on March 17, 2020, the

Secretary issued a declaration pursuant to the PREP Act in order

“to provide liability immunity for activities related to medical

countermeasures against COVID-19.” Declaration Under the Pub-

lic Readiness and Emergency Preparedness Act for Medical Coun-

termeasures Against COVID-19, 85 Fed. Reg. 15,198 (Mar. 17,

2020) (the Declaration).

Under the Declaration, “covered persons” receive PREP Act

immunity for administering “covered countermeasures.” Covered

countermeasures include “any diagnostic [test] . . . used to treat, di-

agnose, cure, prevent, or mitigate COVID-19.” Id. at 15,202. On

April 8, 2020, HHS issued guidance advising that pharmacists were

covered persons for purposes of the Declaration and thus entitled

to PREP Act immunity. U.S. Dep’t of Health and Hum. Servs.,

Guidance for Licensed Pharmacists, COVID-19 Testing, and Im-

munity under the PREP Act (Apr. 8, 2020) [hereinafter, Pharmacist

Guidance], https://www.phe.gov/Preparedness/legal/pre-

pact/Documents/pharmacist-guidance-COVID19-PREP-Act.pdf.

B.

Lisa Leonard and her husband, Craig, are licensed pharma-

cists in Auburn, Alabama. Together they owned and operated

USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 5 of 25

22-11124 Opinion of the Court 5

“The Drug Store” pharmacy. The Drug Store began administering

antibody tests at the end of April 2020, and between April and Sep-

tember of 2020 it administered more than 5,900.

Leonard’s trouble with the Board began during the summer

of 2020. Board investigator Sean Malloy first visited The Drug

Store on June 14, 2020, to address alleged customer privacy com-

plaints. Later, on July 27, 2020, Chuck Beams, a competing phar-

macist at a local hospital, contacted the Board with concerns about

testing practices at The Drug Store. Malloy began corresponding

with Beams about his complaint and, at Malloy’s request, Beams

provided a written statement to Malloy on July 29. Later, after

Beams requested an update on his complaint, Malloy responded on

August 7, 2020, stating that they would be meeting with Leonard

soon and “[i]f all goes the way we plan then I believe we will stop

any further issues from The Drug Store.”

Meanwhile, investigator Glenn Wells called Leonard to dis-

cuss Beams’s complaint. This was not the first time that Wells and

Leonard had crossed paths. In 2005, Leonard accused Wells of

brandishing a gun at her, though Wells denies this. On August 26,

2020, Malloy and Wells visited The Drug Store in person and spoke

with Leonard about the administration of antibody tests at the

pharmacy. A month later, a third investigator named Mark Delk

visited the pharmacy. He requested that Leonard and her husband

provide a written statement about the 2005 incident with Wells.

Following these interactions, Leonard and her pharmacy

voluntarily stopped providing antibody tests without any Board

USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 6 of 25

6 Opinion of the Court 22-11124

action. Nearly seven months later, the Board filed a Statement of

Charges against Leonard and The Drug Store. The charges alleged

that the way the pharmacy administered the antibody tests violated

Alabama’s pharmacy regulations and the Board’s ethics rules.

Among other things, the Charges alleged that the pharmacy mis-

represented the nature of the antibody tests to its customers, failed

to safely dispose of lancets 1 used to administer the tests, and used

alcohol swabs improperly when administering the tests.

Leonard filed this suit in the Middle District of Alabama.

Her complaint, as amended, alleged that the Board’s charges were

violations of antitrust laws, ultra vires, preempted, and unconstitu-

tional. Leonard requested a preliminary injunction to restrain the

Board from proceeding on its Statement of Charges. In particular,

Leonard argued that the PREP Act’s “Targeted [L]iability [P]rotec-

tions,” 42 U.S.C. § 247d-6d, immunized her. The Board moved to

dismiss the complaint for failure to state a claim, and the district

court agreed as to all but the PREP Act claims. Regarding these,

the district court abstained from federal jurisdiction pursuant to

Younger v. Harris, 401 U.S. 37 (1971), and did not reach the merits.

Leonard timely appealed the abstention decision.

1 A lancet is a small, sharp, spring-loaded device that takes small blood sam-

ples.

USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 7 of 25

22-11124 Opinion of the Court 7

II. Standard of Review

We review a district court’s decision to abstain for abuse of

discretion, but it is always an abuse of discretion for a court to apply

an incorrect legal standard. Hughes v. Att’y Gen. of Fla., 377 F.3d

1258, 1262 (11th Cir. 2004). Further, “only the clearest of justifica-

tions merits abstention,” and where Younger’s prerequisites are

not satisfied, federal courts must exercise their jurisdiction. Tokyo

Gwinnett, LLC v. Gwinnett Cnty., 940 F.3d 1254, 1266–67 (11th

Cir. 2019) (quotation marks omitted and alteration adopted) (quot-

ing Jackson-Platts v. Gen. Elec. Capital Corp., 727 F.3d 1127, 1140

(11th Cir. 2020)). However, when the prerequisites are met, “fed-

eral courts may and should withhold equitable relief to avoid inter-

ference with state proceedings.” 31 Foster Child. v. Bush, 329 F.3d

1255, 1274 (11th Cir. 2003) (emphasis added).

III. Principles of Abstention

While the federal courts have a “virtually unflagging” obli-

gation to hear the cases before them, the Younger doctrine pre-

sents a narrow exception. Id. (quoting Colo. River Water Conser-

vation Dist. v. United States, 424 U.S. 800, 817 (1976)). Younger

“requires a federal court to abstain where a plaintiff’s federal claims

could be adjudicated in a pending state judicial proceeding.” Dea-

kins v. Monaghan, 484 U.S. 193, 202 (1988). This reflects the norms

of comity and respect inherent in “Our Federalism.” Younger, 401

U.S. at 44. But “Our Federalism” does not require “blind deference

to ‘States’ Rights,’” id., and not every state judicial proceeding re-

quires federal abstention. The Supreme Court has recognized only

USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 8 of 25

8 Opinion of the Court 22-11124

three types of state proceedings where abstention is warranted: (1)

“criminal prosecutions”; (2) “civil enforcement proceedings”; and

(3) “civil proceedings involving certain orders that are uniquely in

furtherance of the state courts’ . . . judicial functions.” New Orle-

ans Pub. Serv., Inc. v. Council of the City of New Orleans, 491 U.S.

350, 367–68 (1989) (NOPSI) (declining to extend Younger to state

judicial review of legislative or ratemaking actions).

When a federal lawsuit overlaps with one of these types of

state proceedings, and the federal court is asked to interfere in the

state proceeding, the federal court must consider whether the three

factors enumerated in Middlesex County Ethics Committee v. Gar-

den State Bar Association, 457 U.S. 423, 432 (1982), are present:

First, is the state proceeding “ongoing” at the same time as the fed-

eral one? Second, does the state proceeding implicate an “im-

portant state interest”? And third, does the state proceeding pro-

vide an “adequate opportunity” to raise the federal claim? Tokyo

Gwinnett, 940 F.3d at 1268 (citing Middlesex, 457 U.S. at 432).

When these three Middlesex factors are met, Younger ab-

stention is warranted, and the federal court should abstain and al-

low the state proceeding to go forward. But, Younger recognized

that in certain “extraordinary circumstances” a federal court should

refuse to abstain even if the other factors warrant it. Younger, 401

U.S. at 45. We have summarized these circumstances, recognizing

that a federal court should refuse to abstain if: “(1) there is evidence

[the] state proceedings [are] motivated by bad faith, (2) irreparable

injury would occur, or (3) there is no adequate alternative state

USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 9 of 25

22-11124 Opinion of the Court 9

forum where the constitutional issues can be raised.” Hughes, 377

F.3d at 1263 n.6 (citing Younger, 401 U.S. at 45, 53–54). 2

IV. Middlesex Factors

The parties agree that the Board’s proceeding is a “civil en-

forcement action” to which Younger applies, that it was both “on-

going” when the federal suit was filed, and that Alabama has an

“important state interest” in enforcing its pharmacy regulations.

Thus, we train our attention on the third Middlesex factor: whether

the Board’s proceedings provide Leonard an “adequate oppor-

tunity” to assert her PREP Act claims. We conclude they do.

The burden is on the plaintiff to show that the state forum

is not adequate to adjudicate their federal defenses. 31 Foster

Child., 329 F.3d at 1279. Further, when the plaintiff “has not at-

tempted to present [their] federal claims in related state-court pro-

ceedings, a federal court should assume” that the state proceedings

2 The third Hughes exception tracks the third Middlesex factor: whether the

state forum is adequate to hear the plaintiff’s federal claim. Our caselaw has

been ambiguous on whether to treat this consideration as an exception to

Younger, or as a precondition to it. Compare Hughes, 377 F.3d at 1263 n.6,

with Butler v. Ala. Jud. Inquiry Comm’n, 245 F.3d 1257, 1262 (11th Cir. 2001)

(noting “Middlesex sets out three benchmarks” and “the parties do not dis-

pute[] that the first two elements are satisfied here” (emphasis added)). What-

ever tension there is in our caselaw, it is only a tension over labeling, as we

apply the same legal standards in both lines of cases. In this case, the parties

and the district court discussed this factor in the context of Middlesex, and as

a precondition to Younger, so we do the same.

USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 10 of 25

10 Opinion of the Court 22-11124

are adequate, except upon “unambiguous authority to the con-

trary.” Pennzoil Co. v. Texaco, Inc., 481 U.S. 1, 15 (1987).

Adequacy in this context is not about the quality of the state

proceedings, but rather about “whether th[e] challenge can be

raised in the pending state proceedings” at all. Moore v. Sims, 442

U.S. 415, 425 (1979) (emphasis added). In Moore, the State of Texas

had instituted lawsuits to terminate the parental rights of the plain-

tiffs, but the plaintiffs sued in federal court to halt the state proceed-

ings, arguing the Texas laws were unconstitutional. Id. at 419–22.

The district court refused to abstain, concluding that the plaintiffs’

constitutional challenge was “multifaceted” and that there was no

singular, convenient state forum for them to assert their constitu-

tional challenge. Id. at 424. The Supreme Court reversed, conclud-

ing that even though the litigation was complicated, nothing pro-

cedurally stopped the plaintiffs from asserting their constitutional

challenge. Id. at 425–26. The Court noted Texas’s permissive rules

of joinder in parental rights proceedings and that Texas courts were

empowered by statute to hear all claims properly joined. Id. at 425

& n.9.

Simply put, generalized arguments about the inadequacy,

inconvenience, or complexity of proceedings before a state tribunal

will not do. See id. at 425–27. “Instead, what matters is whether

the plaintiff is procedurally prevented from raising his constitu-

tional claims in the state courts, from which a certiorari petition

can be filed seeking review on the merits in the United States Su-

preme Court.” Pompey v. Broward Cnty., 95 F.3d 1543, 1551 (11th

USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 11 of 25

22-11124 Opinion of the Court 11

Cir. 1996) (citing Moore, 442 U.S. at 432). To demonstrate that

claims are procedurally prevented in state tribunals, plaintiffs

should provide evidence of state laws, rules, or procedures that

would allow a district court to evaluate whether the plaintiff’s fed-

eral claims will effectively be shut out from the judicial system and

cut off from effective review in the courts.

Further, in the administrative law context, the Supreme

Court has held that “it is sufficient under Middlesex that constitu-

tional claims may be raised in state-court judicial review of the ad-

ministrative proceeding.” Ohio Civ. Rts. Comm’n v. Dayton

Christian Schs., Inc., 477 U.S. 619, 629 (1986) (internal citation

omitted).

Here, Leonard’s claims of federal preemption and immunity

can be raised both before the Board itself and in Alabama state

court. Board of Pharmacy proceedings are governed both accord-

ing to the requirements of the Board’s organic act, Ala. Code. § 34-

23-1 et seq., and provisions of the Alabama Administrative Proce-

dure Act (AAPA) made applicable to Board proceedings. Ala.

Code. §§ 34-23-92(12), 34-23-94. When the Board seeks to revoke

a pharmacist’s license, it must serve upon the respondent a state-

ment of charges and notice of hearing. Ala. Code §§ 34-23-34, 41-

22-12. After that, the AAPA contemplates that other pleadings and

motions may be filed in advance of the hearing. See, e.g., Ala. Code

§ 41-22-12(c) (“[O]n motion of a party, the presiding officer . . . may

issue . . . discovery orders related to relevant matters . . . in accord-

ance with the rules of civil procedure.”); id. § 41-22-12(g) (“The

USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 12 of 25

12 Opinion of the Court 22-11124

record in a contested case shall include: (1) All pleadings, motions,

and intermediate rulings . . . .”). In fact, the record reveals that

Leonard availed herself of these procedures. She filed answers to

the Board’s original and amended Statements of Charges, and the

parties have requested and received continuances of the Board’s

hearing while this case is pending in federal court. In her answers

to the Statements of Charges, Leonard has asserted and raised not

only her federal preemption and immunity defenses, but also other

defenses grounded in the United States Constitution or federal stat-

utes. The fact that Leonard has been able to assert her federal de-

fenses in the Board’s proceedings all but dooms Leonard’s ade-

quacy argument. Middlesex, 457 U.S. at 437 & n.16 (noting that

“[i]t would trivialize the principles of comity and federalism” to ig-

nore that the state courts had in fact entertained the plaintiff’s fed-

eral claims). But in addition, our review of Alabama’s administra-

tive code and the Board’s organic act confirms that, just like in

Moore, there is nothing procedurally stopping Leonard from hav-

ing her federal defenses considered in the Board’s proceedings.

Moreover, if Leonard does not prevail on her federal de-

fenses before the Board, or even if the Board sidesteps ruling on

Leonard’s federal claims altogether, she can still seek judicial re-

view in the Alabama state courts. See Ala. Code § 41-22-20(a)–(b)

(providing any “person who has exhausted all administrative rem-

edies available” and is still “aggrieved by a final decision in a con-

tested case” may seek review in an Alabama circuit court); id. § 41-

22-21 (providing for appeals from circuit courts’ review of

USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 13 of 25

22-11124 Opinion of the Court 13

administrative proceedings to appropriate Alabama courts of ap-

peals). These reviewing courts would review any legal conclusions

embedded in the Board’s decision de novo. See Ex parte Wilbanks

Health Care Servs., Inc., 986 So. 2d 422, 425 (Ala. 2007) (“Review

of the hearing officer’s conclusions of law . . . is de novo.”); see also

Ala. Code § 41-22-20(k)(1) (“The court may reverse or modify . . .

the agency action . . . if substantial rights of the petitioner have

been prejudiced because the agency action is . . . (1) [i]n violation

of constitutional or statutory provisions.”). If Leonard is not satis-

fied with the review provided by the Alabama courts, she can ulti-

mately petition for review of her federal challenges in the United

States Supreme Court. See 28 U.S.C. § 1257. Therefore, not only

has Leonard been able to present her federal defenses in the admin-

istrative proceeding, but Alabama law also provides that her con-

stitutional claims may be raised in Alabama’s courts consistent with

Ohio Civil Rights Commission. See 477 U.S. at 629. Leonard has

simply not carried her heavy burden under our precedents to show

that the state forum is inadequate. See 31 Foster Child., 329 F.3d

at 1279.

Leonard also argues that, even if she could get an adjudica-

tion at some point, that it would be too late to adequately vindicate

her rights. The PREP Act provides immunity for providers of cov-

ered countermeasures “from suit and liability” related to the ad-

ministration of those countermeasures. 42 U.S.C. § 247d-6d(a)(1).

Leonard claims her immunity “from suit” will be violated if she is

forced to participate in the hearing or to seek state appellate review

USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 14 of 25

14 Opinion of the Court 22-11124

on the back end of those proceedings. She analogizes this situation

to the world of qualified immunity jurisprudence, which generally

allows state governmental officials to immediately take an interloc-

utory appeal of a denial of qualified immunity. See Mitchell v. For-

syth, 472 U.S. 511, 526 (1985) (“[A]n immunity from suit . . . is ef-

fectively lost if a case is erroneously permitted to go to trial.”). But

this argument fails because the AAPA does provide for interlocu-

tory review of preliminary administrative rulings: “A preliminary,

procedural, or intermediate agency action or ruling is immediately

reviewable if review of the final agency decision would not provide

an adequate remedy.” Ala. Code § 41-22-20(a). The AAPA and the

Board’s hearing procedures thus provide exactly what Leonard

seeks: she may move the hearing officer to dismiss the Statement

of Charges, and if denied, she may seek judicial review of that de-

nial in Alabama state court. Because Leonard has not attempted to

avail herself of this procedural avenue, she bears the even heavier

burden of providing “unambiguous authority” that this procedure

is inadequate. Pennzoil, 481 U.S. at 15. She has not done so in this

case, and so we hold that Alabama’s administrative and judicial sys-

tem is adequate under Middlesex to adjudicate her claims of PREP

Act immunity and preemption.

V. Younger Exceptions

Because all three Middlesex factors are satisfied, Younger ab-

stention is warranted unless Leonard can show that one of the ex-

ceptions applies. Younger’s progeny have crystalized these excep-

tions into two broad categories: proceedings instituted in “bad

USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 15 of 25

22-11124 Opinion of the Court 15

faith” and proceedings founded on “flagrantly and patently” uncon-

stitutional laws. We address each in turn.

A. Bad-Faith Exception

In Kugler v. Helfant, 421 U.S. 117 (1975), the Supreme Court

held that bad faith “in this context generally means that a prosecu-

tion has been brought without a reasonable expectation of obtain-

ing a valid conviction.” Id. at 126 n.6. We applied this standard in

Redner v. Citrus County, 919 F.2d 646 (11th Cir. 1990). There, the

plaintiff argued that he was being targeted in bad faith by the

county because it passed an ordinance outlawing adult stores the

day before he opened his own adult store business. Id. at 650 n.8.

We held this was insufficient to show bad faith because whether or

not the ordinance had a targeted scope did not bear on the question

of whether the prosecution had a “reasonable expectation” of suc-

cess. See id. at 650 & n.8 (quoting Kugler, 421 U.S. at 126 n.6).

Leonard argues that a pair of old Fifth Circuit cases show

that the bad-faith exception applies even when there is a “reasona-

ble expectation” of success if the charges were instituted for the

purpose of harassment. See Wilson v. Thompson, 593 F.2d 1375,

1387 (5th Cir. 1979); Fitzgerald v. Peek, 636 F.2d 943, 945 (5th Cir.

Jan. 1981) (per curiam). 3 Our predecessor court did once remark,

“[n]or is it necessary for [a] plaintiff to prove that the prosecution

3 In Bonner v. City of Prichard, 661 F.2d 1206, 1209 (11th Cir. 1981) (en banc),

we adopted as binding precedent all decisions of the former Fifth Circuit

handed down prior to October 1, 1981.

USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 16 of 25

16 Opinion of the Court 22-11124

could not possibly result in a valid conviction.” Fitzgerald, 636 F.2d

at 945. But it made this statement in the context of retaliation

against core constitutionally protected rights. See id. (requiring the

plaintiff to show “that the conduct allegedly retaliated against . . .

is constitutionally protected and that the state’s [charges are] moti-

vated at least in part by a purpose to retaliate against or deter that

conduct”); Wilson, 593 F.2d at 1383 (concluding abstention is not

warranted if the state charges were “brought in bad faith for the

purpose of retaliating for or deterring the exercise of constitution-

ally protected rights”).

In Fitzgerald, the plaintiffs made critical comments about lo-

cal public officials, and local judges exerted pressure on the district

attorney to bring charges in retaliation for these comments. 636

F.2d at 944–45. In Wilson, criminal charges against the plaintiffs

were revived after the local authorities learned the plaintiffs had

filed a civil suit against two local sheriff’s deputies. 593 F.2d at

1377–79. In both cases, the plaintiffs showed that the charges were

brought in retaliation against the exercise of their protected First

Amendment Rights. What is more, requiring that harassment be

targeted at a constitutional right is consistent with the practice of

our sister circuits. See, e.g., Phelps v. Hamilton, 59 F.3d 1058,

1064–65, 1064 n.12 (10th Cir. 1995) (collecting cases and distin-

guishing between those bad-faith prosecutions that lack “probable

cause” and ones brought to “chill[]” the exercise of constitutional

rights); Lewellen v. Raff, 843 F.2d 1103, 1109–10 (8th Cir. 1988)

(similar); Cullen v. Fliegner, 18 F.3d 96, 103–04 (2d Cir. 1994)

USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 17 of 25

22-11124 Opinion of the Court 17

(affirming non-abstention based on district court’s finding that

state’s proceedings “‘imposed a chilling effect’ on Appellee’s First

Amendment rights”).

Here, Leonard’s failure to identify constitutionally protected

conduct that is being retaliated against forecloses her harassment

argument. Our precedents distinguish between cases where

charges are brought to target protected conduct and those where

“the only constitutional issue at stake is the validity of the chal-

lenged state [charges].” Wilson, 593 F.2d at 1382–83 (quotation

marks omitted) (citation omitted). Leonard’s case falls neatly into

the latter category.

* * *

Because Leonard cannot show harassment in response to

the exercise of her constitutional rights, she must instead show that

the charges were “brought without a reasonable expectation of ob-

taining a valid conviction” in order to invoke the bad-faith excep-

tion. Redner, 919 F.2d at 650 (quoting Kugler, 421 U.S. at 126 n.6).

However, none of the facts to which Leonard points make this

showing. As an initial matter, Leonard has not provided any sub-

stantial allegation that the Board itself, or its individual members,

are acting in bad faith. Leonard instead focuses on the alleged bad

faith of the Board’s investigators: Malloy, Delk, and Wells. The

Board argues that any bad faith attributable to its investigators

should not be automatically imputed to the Board without some

evidence that the Board adopted that bad faith. We need not de-

cide whose intent matters, though, because even focusing solely on

USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 18 of 25

18 Opinion of the Court 22-11124

the investigators’ intent, Leonard has still not carried her burden

under Redner. 4

Turning to the investigators’ alleged bad faith, Leonard

points to three sets of facts in an attempt to carry her burden. First,

she alleges that investigator Malloy’s territory did not include The

Drug Store. Even if true, we cannot see how this bears on the ques-

tion of whether the charges were instituted without a reasonable

expectation of success.

Second, she points to the anti-competitive motives of Chuck

Beams (a competing pharmacist) and his interactions with Malloy.

However, the motives of Beams in isolation are irrelevant to the

bad-faith analysis, as he had no involvement in the charging pro-

cess. His allegedly bad-faith motives are only relevant to the extent

that they were adopted by the Board’s investigators. Leonard

points to the emails exchanged between Malloy and Beams, but

fails to provide more than a conclusory explanation how these

emails would show bad faith. After reviewing the record in con-

text, these emails on their face evince just benign professional

4 To be clear, there is good reason to doubt that Leonard could in fact show

that the Board’s decisionmaking was infected with any of the alleged bad faith

of its investigators. The record evidence demonstrates that the Board’s mem-

bers are insulated from their staff until the hearing date so that they can be

impartial adjudicators of the charges. In addition, the record shows that the

investigators’ findings are further filtered through the Board’s staff counsel and

Executive Secretary, who act as another impartial layer between the investi-

gators and the Board members.

USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 19 of 25

22-11124 Opinion of the Court 19

courtesy. Malloy requested that Beams make a statement in writ-

ing about his complaint, and after he did, Malloy thanked him for

sending it. Later, Malloy responded to Beams’s request for an up-

date on his complaint, and Malloy let him know the investigation

would probably be ending soon. Even if these emails were con-

strued in a more sinister fashion, they still do not show whether the

Board had a reasonable expectation of success in bringing its

charges.

Finally, Leonard alleges that the mere involvement of inves-

tigator Wells shows bad faith. Again, Leonard has not suggested

what inference we should draw from the simple fact of his involve-

ment. Her argument appears to be that, because Leonard accused

Wells of drawing a gun on her in 2005, he was biased in his present-

day interactions with Leonard and her staff. But this too has no

bearing on the showing required under Redner. Whether Wells

had a personal animosity towards Leonard says next to nothing

about whether the Board’s charges were instituted without a rea-

sonable expectation of success.

Leonard has alleged facts that, when drawn in her favor,

might suggest that the investigators were personally hostile to her

and her business. But, like in Redner, being the target of the

Board’s investigators is not itself evidence of bad faith, and Leonard

has not shown any evidence that because of this hostility the

Board’s charges were baseless. Because Leonard has not carried

her burden under either the “reasonable expectation” standard or

USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 20 of 25

20 Opinion of the Court 22-11124

the harassment standard, the bad-faith exception to Younger does

not apply.

B. Flagrantly Unconstitutional Laws Exception

A prosecution founded on “flagrantly and patently” uncon-

stitutional laws would also constitute the sort of “extraordinary cir-

cumstance” justifying federal intervention in state proceedings.

Younger, 401 U.S. at 53. The Supreme Court suggested in NOPSI

that this exception might be satisfied if there was a “facially conclu-

sive” claim of preemption. See NOPSI, 491 U.S. at 367.

We previously considered the scope of the “facially conclu-

sive” form of this exception in Hughes v. Attorney General of Flor-

ida, 377 F.3d 1258 (11th Cir. 2004). There, we noted the narrow-

ness of the exception and held that “only the clearest of federal

preemption claims” would justify a federal court interfering in a

case pending before an otherwise adequate state tribunal. Id. at

1265 & n.10; see also Younger, 401 U.S. at 53–54 (suggesting the

exception applies in the narrow instance where state laws are un-

constitutional “in every clause, sentence and paragraph, and in

whatever manner and against whomever” they are applied (quot-

ing Watson v. Buck, 313 U.S. 387, 402 (1941))). In Hughes, the

plaintiffs were being prosecuted under Florida law for operating an

aircraft while intoxicated. 377 F.3d at 1260–61. We reversed the

grant of a writ of habeas corpus halting the prosecutions, because

it was not “absolutely clear” that the state laws were preempted by

the federal aviation laws. Id. at 1261, 1271–72; see also id. at 1273–

74 (reasoning that unresolved tensions between competing parts of

USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 21 of 25

22-11124 Opinion of the Court 21

the regulatory scheme meant that preemption was not facially con-

clusive).

While the parties extensively briefed the issue, we need not

decide the total scope of PREP Act preemption today. Because the

Middlesex factors are satisfied, and Younger abstention is war-

ranted in this case, our only question is whether this case is one of

the “clearest” cases of preemption, justifying non-abstention in

spite of the Middlesex factors. Hughes, 377 F.3d at 1265. After ap-

plying the principles of preemption, we conclude Leonard’s claim

is not “facially conclusive.”

1. Principles of Preemption

Federal preemption of state law flows from the Supremacy

Clause of the United States Constitution. U.S. Const. art. VI, cl. 2.

Under our system of federalism, there is a presumption against con-

struing statutes to preempt the “historic police powers” of the

states to regulate for the health and safety of their citizens, unless

it is the “manifest purpose of Congress” to do so. See Cipollone v.

Liggett Grp., Inc., 505 U.S. 504, 516 (1992) (quoting Rice v. Santa

Fe Elevator Corp., 331 U.S. 218, 230 (1947)). So, when we evaluate

the scope of federal preemption, “the purpose of Congress is the

ultimate touchstone.” Id. (alteration adopted) (quoting Malone v.

White Motor Corp., 435 U.S. 497, 504 (1978)). Congress’s purpose

may be stated explicitly, or it may be implicit in the structure and

substance of the statute. Id. When it is explicit in the text of the

statute, our “task is one of statutory interpretation.” See id. at 532

(Blackmun, J., concurring in part); see also id. at 517 (majority

USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 22 of 25

22 Opinion of the Court 22-11124

opinion) (applying the traditional statutory canon of expressio

unius to interpret the express preemption provision). In situations

where Congress has not spoken explicitly, preemption may still oc-

cur through Congress’s enactment of laws that actually conflict

with state laws “or where the scheme of federal regulation is suffi-

ciently comprehensive” to suggest that Congress intended to oc-

cupy the field of regulation to the exclusion of the States. Lawson-

Ross v. Great Lakes Higher Educ. Corp., 955 F.3d 908, 916 (11th

Cir. 2020) (internal quotation marks omitted).

2. PREP Act Preemption

Here, the PREP Act contains an express preemption clause,

it reads:

(8) Preemption of State law

During the effective period of a declaration under

subsection (b), or at any time with respect to conduct

undertaken in accordance with such declaration, no

State or political subdivision of a State may establish,

enforce, or continue in effect with respect to a cov-

ered countermeasure any provision of law or legal re-

quirement that—

(A) is different from, or is in conflict with, any

requirement applicable under this section; and

(B) relates to the [creation, use, administration,

etc. of covered countermeasures]

42 U.S.C. § 247d-6d(b)(8).

USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 23 of 25

22-11124 Opinion of the Court 23

Here, the Declaration and its guidance documents provide

that Covid-19 antibody tests are covered countermeasures and that

pharmacists are covered persons. Declaration, supra, 85 Fed. Reg.

at 15,202; Pharmacist Guidance, supra. Thus, the relevant preemp-

tion question here is whether the Board’s charges are “different

from” or “in conflict with” the PREP Act and the Declaration.

Because the PREP Act has an express preemption provision,

we begin with the text. See Medtronic, Inc. v. Lohr, 518 U.S. 470,

484–85 (1996). The PREP Act only preempts state laws that conflict

with “requirements” of the PREP Act or the Declaration. Leonard

argues that the PREP Act’s immunity from “suit and liability . . .

for a claim for loss” is a requirement under the Act, and the Board’s

charges seeking to impose liability are in conflict with it. But the

Board notes that its charges are not “claims for loss.” In fact, as the

Board notes, there is no loss—these are administrative enforce-

ment charges only. While Leonard argues that the “loss” in this

case is the loss of her license if the Board is successful, this reading

stretches the text too far. The more natural reading of the statute

is that covered persons are immunized from suits by plaintiffs try-

ing to recover for the plaintiffs’ losses caused by covered persons,

not suits by those seeking to impose a loss on the covered person.

However, because Congress’s purpose is the “touchstone”

of our analysis, we must place this text in the context of the whole

statute. Leonard argues that even if the Board’s charges are admin-

istrative, the statutory authority under which the charges are

brought speaks in the language of tort law. See, e.g., Ala. Code

USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 24 of 25

24 Opinion of the Court 22-11124

§ 34-23-33(a)(6) (providing that the Board may revoke a pharma-

cist’s license for “gross malpractice” and “gross negligence”). She

correctly notes that the few cases to have addressed PREP Act

preemption have generally concluded that state tort law is

preempted with respect to the administration of covered counter-

measures. See, e.g., Parker v. St. Lawrence Cnty. Pub. Health

Dep’t, 954 N.Y.S. 2d 259 (N.Y. App. Div. 2012). Further, the text of

the PREP Act provides guidance on Congress’s purpose: PREP Act

declarations are issued to “encourag[e]” the administration of cov-

ered countermeasures. 42 U.S.C. § 247d-6d(b)(6) (describing the

factors to be considered). With this in mind, we understand Leon-

ard’s argument that it would seem odd for Congress to immunize

covered persons from private suits for damages, while still subject-

ing them to government administrative actions seeking to revoke

their licenses for the same conduct.

With the text of the statute pulling in one direction and Con-

gress’s purpose arguably pulling in the other, “it is not absolutely

clear to us, i.e., facially conclusive” that we should resolve this ten-

sion in favor of finding preemption. See Hughes, 377 F.3d at 1271.

Leonard’s claim is not one of “the clearest of federal preemption

claims” that would justify federal intervention in spite of the Mid-

dlesex factors being satisfied. See id. at 1265. Nor can we see from

the face of the Board’s charges that they are “flagrantly and patently

violative of express constitutional prohibitions in every clause, sen-

tence and paragraph, and in whatever manner” as applied against

Leonard. Younger, 401 U.S. at 53–54 (quoting Watson, 313 U.S. at

USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 25 of 25

22-11124 Opinion of the Court 25

402). Therefore, we conclude that this exception is also not appli-

cable to Leonard’s case.

VI. Conclusion

Our holding today is a limited one. We conclude that Leon-

ard has not established that she lacks an adequate opportunity to

present her federal claims to the Alabama Board of Pharmacy or an

adequate opportunity to obtain judicial review of her claims in Al-

abama’s courts, and so Younger abstention is warranted. We do

not decide today whether Leonard is immune from the Board’s

charges or if they are in fact preempted by the PREP Act. All we

conclude is that this is not one of the “extraordinary circumstances”

that would justify federal intervention in a state proceeding that is

adequate to hear Leonard’s claims. Accordingly, the district court

did not abuse its discretion and is due to be affirmed.

AFFIRMED.