Apter v. Dept of Health & Human Svc

Case: 22-40802 Document: 00516882138 Page: 1 Date Filed: 09/01/2023

United States Court of Appeals

for the Fifth Circuit United States Court of Appeals

Fifth Circuit

____________ FILED

September 1, 2023

No. 22-40802

Lyle W. Cayce

____________ Clerk

Robert L. Apter; Mary Talley Bowden; and Paul E. Marik,

Plaintiffs—Appellants,

versus

Department of Health & Human Services; Xavier

Becerra, in his official capacity as Secretary of Health and Human Services;

Food & Drug Administration; Robert M. Califf, in his

official capacity as Commissioner of Food and Drugs,

Defendants—Appellees.

______________________________

Appeal from the United States District Court

for the Southern District of Texas

USDC No. 3:22-CV-184

______________________________

Before Clement, Elrod, and Willett, Circuit Judges.

Don R. Willett, Circuit Judge:

“You are not a horse.”

Or so the Food and Drug Administration (“FDA”) alerted millions

of Americans via social media, midway through the COVID-19 pandemic.

The agency had discerned that some people were treating their symptoms

using the animal version of a drug called ivermectin. FDA decided to target

that practice via the “horse” message—and others like it. The messaging

Case: 22-40802 Document: 00516882138 Page: 2 Date Filed: 09/01/2023

No. 22-40802

traveled widely across legacy and online media. Left unmentioned in most of

that messaging: ivermectin also comes in a human version. And while the

human version of ivermectin is not FDA-approved to treat the coronavirus,

some people were using it off-label for that purpose.

The Appellants are three medical Doctors who prescribed the human

version of ivermectin to thousands of their patients. Each Doctor says that

FDA’s messaging interfered with their own individual medical practice. The

Doctors sued FDA and the Department of Health and Human Services

(together, the “Agencies”). They also sued two governmental employees in

their official capacities (the “Officials”). The Doctors argue that FDA’s

“horse” message and similar public statements (together, the “Posts”)

violate FDA’s enabling act (“Act”) and the Administrative Procedure Act

(“APA”). The district court held that sovereign immunity protects the

Agencies and the Officials, and it dismissed the suit. We disagree.

First, the Doctors can use the APA to bypass sovereign immunity and

assert their ultra vires claims against the Agencies and the Officials. FDA is

not a physician. Thus, assuming FDA is correct that we must consider the

merits to some degree even at the pleading stage, the Posts that issue medical

advice to consumers are plausibly ultra vires. The Posts are plausibly agency

action, too, because they publicly announce the general principle that

consumers should not use ivermectin to treat the coronavirus, and because

the Doctors fall within the Act’s zone of interests. Second, because the

Doctors can use the APA for their ultra vires claims, we need not consider

the common-law version of that doctrine. Third, however, the Doctors’ pure

APA claim cannot go forward. That is because the Posts do not determine

legal rights and thus lack the finality. Even though this last theory fails, the

Doctors’ first theory is enough to allow this suit to proceed.

We REVERSE and REMAND.

2

Case: 22-40802 Document: 00516882138 Page: 3 Date Filed: 09/01/2023

No. 22-40802

I

A

Ivermectin is a drug. About eighteen months into the COVID–19

pandemic, the Food and Drug Administration released an informal

“Consumer Update” titled “Why You Should Not Use Ivermectin to Treat

or Prevent COVID-19” (“Update”). The current version of the Update

reads, in part (internal headings omitted):

COVID-19. We’ve been living with it for what sometimes

seems like forever. Given the number of deaths that have

occurred from the disease, it’s perhaps not surprising that

some consumers are turning to drugs not approved or

authorized by the Food and Drug Administration . . . .

...

There seems to be a growing interest in a drug called

ivermectin for the prevention or treatment of COVID-19 in

humans. Certain animal formulations of ivermectin such as

pour-on, injectable, paste, and “drench,” are approved in the

U.S. to treat or prevent parasites in animals. For humans,

ivermectin tablets are approved at very specific doses to treat

some parasitic worms, and there are topical (on the skin)

formulations for head lice and skin conditions like rosacea.

However, the FDA has received multiple reports of patients

who have required medical attention, including hospitalization,

after self-medicating with ivermectin intended for livestock.

• The FDA has not authorized or approved ivermectin

for use in preventing or treating COVID-19 in humans

or animals. Ivermectin is approved for human use to

treat infections caused by some parasitic worms and

head lice and skin conditions like rosacea.

• Currently available data do not show ivermectin is

effective against COVID-19. Clinical trials assessing

3

Case: 22-40802 Document: 00516882138 Page: 4 Date Filed: 09/01/2023

No. 22-40802

ivermectin tablets for the prevention or treatment of

COVID-19 in people are ongoing.

• Taking large doses of ivermectin is dangerous.

• If your health care provider writes you an ivermectin

prescription, fill it through a legitimate source such as a

pharmacy, and take it exactly as prescribed.

• Never use medications intended for animals on yourself

or other people. Animal ivermectin products are very

different from those approved for humans. Use of

animal ivermectin for the prevention or treatment of

COVID-19 in humans is dangerous.

....

The FDA has not authorized or approved ivermectin for the

treatment or prevention of COVID-19 in people or animals.

Ivermectin has not been shown to be safe or effective for these

indications.

There’s a lot of misinformation around, and you may have

heard that it’s okay to take large doses of ivermectin. It is not

okay.

....

Talk to your health care provider about available COVID-19

vaccines and treatment options. Your provider can help

determine the best option for you, based on your health

history.1

FDA also released a document titled “FAQ: COVID-19 and

Ivermectin Intended for Animals” (“FAQ”). Together, the Update and the

FAQ total about four pages. In addition to those releases, FDA also posted

_____________________

1

Food and Drug Admin., Why You Should Not Use Ivermectin to Treat or Prevent

COVID-19 (Dec. 10, 2021), https://www.fda.gov/consumers/consumer-updates/why-

you-should-not-use-ivermectin-treat-or-prevent-covid-19 (emphases in original).

4

Case: 22-40802 Document: 00516882138 Page: 5 Date Filed: 09/01/2023

No. 22-40802

four items online between August 2021 and April 2022—one on its website,

and three across social media. The website post reads, in part: “Q: Should I

take ivermectin to prevent or treat COVID-19. A: No.” The three social

media posts are similar. They say, in full:

• “You are not a horse. You are not a cow. Seriously, y’all.

Stop it.”

• “You are not a horse. Stop it with the #ivermectin. It’s not

authorized for treating #COVID.”

• “Hold your horses, y’all. Ivermectin may be trending, but

it still isn’t authorized or approved to treat COVID-19.”

FDA included an image of a horse in each of the three social media posts.

We refer to these six items as the “Posts” (that is: the Update, the FAQ, the

website post, and the three social-media posts).

In an internal email, a member of FDA’s communications team

referred to the Posts as part of a new engagement strategy. The strategy

played well, and media outlets nationwide ran headlines and stories

emphasizing FDA’s “horse” messages. Medical organizations also took

note of the Posts, as did pharmacy boards and hospitals. Federal and state

courts, too, began citing the Posts in cases involving ivermectin. All told, the

Posts—and particularly the Update—saw citations in newspapers,

magazines, digital media outlets, medical and professional advisories, legal

complaints, and judicial opinions across the Nation.

The Plaintiffs–Appellants in this case are three Doctors who have

prescribed the human version of ivermectin to thousands of patients suffering

from the coronavirus. The Doctors allege that the Posts interfered with their

individual “ability to exercise professional medical judgment in practicing

medicine.” The Doctors also allege that the Posts harmed their reputations.

Further, Dr. Apter alleges that he was “referred to [two state medical boards]

5

Case: 22-40802 Document: 00516882138 Page: 6 Date Filed: 09/01/2023

No. 22-40802

. . . for prescribing ivermectin to treat COVID-19,” and that “[t]he referrals

include copies of FDA’s [Posts].” Dr. Apter and Dr. Bowden each say that

pharmacies have refused to fill ivermectin prescriptions for their patients

because of FDA’s Posts. Dr. Bowden also lost her admitting privileges at a

hospital after “tweeting about using ivermectin to treat patients with

COVID-19.” And Dr. Marik lost his positions at a medical school and at a

hospital “for promoting the use of ivermectin.”

B

The Doctors sued FDA, arguing that the Posts are ultra vires under

FDA’s enabling Act and unlawful under the APA.2 The Doctors asked the

district court to:

• set the Posts aside, and declare them unlawful;

• declare that FDA cannot interfere with the practice of

medicine;

• declare that “FDA cannot issue statements or directives

about how or whether health professionals should use

ivermectin off-label to treat patients, and that such FDA

actions have no legal effect and do not bind health

professionals or patients”; and to

• enjoin FDA “from engaging in such actions.”

FDA moved to dismiss the Doctors’ complaint under Rule (12)(b)(1),

invoking sovereign immunity and arguing that the Doctors lack standing to

sue under Article III. While noting that “FDA could have, and perhaps

_____________________

2

FDA’s enabling act is the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.

§§ 301–399i (the “Act”). By “APA,” we mean the Administrative Procedure Act,

5 U.S.C. §§ 551–59, 701–06. Separately, while this case’s caption includes additional

defendants (beyond FDA), the distinctions between them are not relevant for most aspects

of this appeal, and the parties refer primarily to FDA. Except where noted, we do the same.

6

Case: 22-40802 Document: 00516882138 Page: 7 Date Filed: 09/01/2023

No. 22-40802

should have, been more prudent in their communications,” the district court

nonetheless held that sovereign immunity protects FDA and the other

defendants, and it therefore dismissed the suit.3

The district court first held that the Doctors cannot rely on the narrow

ultra vires exception to sovereign immunity.4 The district court began with

the premise that an act is ultra vires only if it is “without any authority

whatsoever” or is “made without any colorable basis for authority.” 5 The

court noted that Congress charged FDA “with protecting public health and

ensuring that regulated medical products are safe and effective.” 6 And it

observed that “FDA has the authority, generally, to make public statements

in-line with these purposes.”7 Therefore, the district court held, “it cannot

be said that the FDA had no colorable basis of authority” to issue the Posts.8

The district court then turned to § 396 of the Act, which says that

“[n]othing in this chapter shall be construed to limit or interfere with the

authority of a health care practitioner to prescribe or administer any legally

marketed device to a patient.”9 The Doctors argued that this section

prohibits FDA from recommending for or against the off-label use of any

_____________________

3

Apter v. U.S. Dep’t of Health & Hum. Servs., ___ F. Supp. 3d ___, No. 3:22-CV-

184, 2022 WL 17578869, at *5, *7 (S.D. Tex. Dec. 6, 2022).

4

Id. at *5.

5

Id. at *4 (citing Danos v. Jones, 652 F.3d 577, 583 (5th Cir. 2011)).

6

Id. at *5 (citing 21 U.S.C. § 393(b)(1)–(b)(2)).

7

Id. (emphasis added).

8

Id.

9

Id. at *4 (quoting 21 U.S.C. § 396).

7

Case: 22-40802 Document: 00516882138 Page: 8 Date Filed: 09/01/2023

No. 22-40802

drug.10 The district court deemed § 396 inapplicable, holding that the

section’s plain text refers only to “devices”—not “drugs.”11

Next, the district court concluded that the Posts are not final agency

action, and thus that the APA’s waiver of sovereign immunity is also

unavailable. The court reasoned that the Posts lack finality because “[n]one

of the statements determine rights, obligations, or legal consequences.” 12

Moreover, “at least some of the statements do not mark the consummation

of the agency’s decisionmaking process.”13 Instead, the Posts “include

language indicating that they were made based on ‘currently available data,’

[and that] ‘additional testing was needed,’ ‘clinical trials were ongoing,’ and

‘initial research was underway.’”14 As the district court explained, “there is

no indication the FDA has adopted a legal position, [and] no indication of

any future liability on non-complying parties. ”15 The court expressly

declined to analyze the Doctors’ hybrid theory, under which the general

waiver of sovereign immunity in the APA also waives sovereign immunity

for non-statutory causes of action such as ultra vires suits.16

Because the district court relied on sovereign immunity, it did not

address Article III standing. The Doctors timely appealed.

_____________________

10

“Off-label” use occurs when a drug is used “for some other purpose than that

for which it has been approved by the FDA.” Buckman Co. v. Plaintiffs’ Legal Comm., 531

U.S. 341, 350 (2001).

11

Apter, 2022 WL 17578869, at *4 & n.6.

12

Id. at *6.

13

Id. at *5.

14

Id. (alterations adopted).

15

Id. at *7.

16

See id. at *3 (“The APA and ultra vires . . . are two distinct waivers of sovereign

immunity, and thus it would be incorrect to use the two interchangeably.”).

8

Case: 22-40802 Document: 00516882138 Page: 9 Date Filed: 09/01/2023

No. 22-40802

II

The district court had federal-question jurisdiction under 5 U.S.C.

§ 702 and under 28 U.S.C. §§ 1331, 1346, 1361, and 2201. We have appellate

jurisdiction under 28 U.S.C. §§ 1291 and 1292. We review dismissals for

sovereign immunity and lack of subject-matter jurisdiction de novo,17

“accept[ing] all factual allegations in the plaintiff’s complaint as true.”18

“[T]he party asserting federal subject-matter jurisdiction[] has the burden of

proving” that jurisdiction is present.19

III

We begin with sovereign immunity.

“The United States may not be sued except to the extent that it has

consented to suit . . . .”20 As such, “where the United States has not

consented to suit or the plaintiff has not met the terms of the statute

[authorizing suit,] the court lacks jurisdiction and the action must be

dismissed.”21 The Doctors rely on three theories to overcome sovereign

immunity: (1) the ultra vires doctrine via the APA, (2) the ultra vires doctrine

itself, and (3) the APA itself. The district court rejected all three paths.22

_____________________

17

Louisiana v. United States, 948 F.3d 317, 320 (5th Cir. 2020).

18

Den Norske Stats Oljeselskap As v. HeereMac Vof, 241 F.3d 420, 424 (5th Cir.

2001).

19

Alabama-Coushatta Tribe of Tex. v. United States, 757 F.3d 484, 487 (5th Cir.

2014).

20

Gonzalez v. Blue Cross Blue Shield Ass’n, 62 F.4th 891, 898 (5th Cir. 2023)

(alterations adopted) (internal quotation marks and citation omitted).

21

Id.

22

Apter, 2022 WL 17578869, at *4–7.

9

Case: 22-40802 Document: 00516882138 Page: 10 Date Filed: 09/01/2023

No. 22-40802

We conclude that the first path is open: the Doctors can use the APA

to assert their ultra vires claims against the defendants. FDA can inform, but

it has identified no authority allowing it to recommend consumers “stop”

taking medicine. The Doctors can therefore use the APA to assert their ultra

vires challenge to the Officials’ actions, and to overcome the sovereign

immunity that would otherwise protect the Agencies. Accordingly, we need

not consider the second path, under which the Doctors attempt to assert their

ultra vires claims using only the common law. However, we do reject the third

path. The Posts are not “final” agency action, and immunity thus bars the

Doctors’ claims from proceeding solely under the APA’s general provisions.

A

The Doctors can use the APA assert their ultra vires claims as a non-

statutory cause of action against the Officials and against the Agencies.

1

At common law, “[t]he ultra vires exception to sovereign immunity

. . . provides that ‘where the officer’s powers are limited by statute, his

actions beyond those limitations are considered individual and not sovereign

actions.’”23 “Such actions are ‘ultra vires [i.e. beyond] his authority and

therefore may be made the object of specific relief.’” 24 “To invoke this

exception, a plaintiff must ‘do more than simply allege that the actions of the

officer are illegal or unauthorized.’”25 Rather, “[t]he complaint must allege

facts sufficient to establish that the officer was acting ‘without any authority

_____________________

23

Danos, 652 F.3d at 583 (quoting Larson v. Domestic & Foreign Com. Corp., 337

U.S. 682, 689 (1949)).

24

Id.

25

Id. (quoting Ala. Rural Fire Ins. Co. v. Naylor, 530 F.2d 1221, 1226 (5th Cir.

1976)).

10

Case: 22-40802 Document: 00516882138 Page: 11 Date Filed: 09/01/2023

No. 22-40802

whatever,’ or without any ‘colorable basis for the exercise of authority.’” 26

Under the common-law ultra vires doctrine, then, a strong merits argument

is needed to overcome sovereign immunity—even at the pleading stage.

As a threshold matter, FDA argues that we must apply the common

law’s merits-adjacent inquiry to the Doctors’ “ultra vires claim” as a

whole—even to the aspects of that claim that the Doctors assert under the

APA. Assuming without deciding that FDA is correct about that, we

conclude that the Doctors’ ultra vires claim has merit enough to overcome

immunity under the common law, and therefore under the APA as well.

For instance, one of the Doctors’ foremost arguments under the ultra

vires doctrine is that FDA has statutory authority to share data, facts, and

knowledge, but not to recommend treatments or give other medical advice.

The argument proceeds along these lines: (1) FDA cannot act without

express statutory authority, (2) FDA does not have express authority to

recommend against off-label uses of drugs approved for human use, (3) the

Posts recommend against ivermectin, therefore (4) the Posts are beyond

FDA’s authority. We agree that, at this stage, FDA has not offered even a

“colorable basis” for rejecting this argument.27

The district court rejected the third premise, reasoning that FDA, has

authority “to make public statements,” and that “there is no statute saying

otherwise.”28 FDA echoes the district court’s reasoning on appeal, claiming

that it “has inherent authority to communicate information to the public.”

But this approach assumes that the Posts contain only factual statements and

_____________________

26

Id. (quoting Pennhurst State Sch. & Hosp. v. Halderman, 465 U.S. 89, 101 n. 11

(1984)).

27

Id.

28

Apter, 2022 WL 17578869, at *5.

11

Case: 22-40802 Document: 00516882138 Page: 12 Date Filed: 09/01/2023

No. 22-40802

information, and that they do not contain any medical recommendations or

advice. But FDA does not defend that assumption. Nor do we see much

supporting the position. On the contrary, all six of the Posts contain syntax

that is imperative rather than declaratory (for example: “Stop it,” “Stop it

with the #ivermectin,” and “Q: Should I take ivermectin to prevent or treat

COVID-19? A: No.”). For that reason, we are unable to draw any analytical

distinction between FDA making the Posts versus FDA telling Americans

to “Stop it” with acetaminophen or antibiotics.

FDA does not argue that it actually does have authority to issue advice

(as opposed to information). That is, FDA never disputes what we have

labeled as the Doctors’ second premise, above. Instead, FDA argues only

that the Posts do not contain advice. For instance, FDA’s brief argues that

“FDA’s informational statements do not ‘direct’ consumers, or anyone

else, to do or refrain from doing anything.” Likewise, FDA’s brief says that

the Posts are “purely informational.” At the same time, however, FDA’s

brief also concedes that the Posts “provided recommendations” and

“advise[d] consumers.” Despite these concessions, FDA never points to

any authority that allows it to issue recommendations or give medical advice.

Rather, FDA argues that some Posts included a hyperlink that leads

to the Update. The Update, in turn, directs consumers to “[t]alk to your

health care provider.” But not all of the social-media posts included such a

link. And even for those Posts that did include a link, the Posts themselves

offer advice, not mere information. The same is true of the Update itself. It

says: “If your health care provider writes you an ivermectin prescription, fill

it through a legitimate source such as a pharmacy, and take it exactly as

prescribed.” But the Update’s title is “Why You Should Not Use Ivermectin

to Treat or Prevent COVID-19” (emphasis added). As with “Click It or

Ticket,” the trailing qualifier does not lessen the opening instruction’s

imperative character.

12

Case: 22-40802 Document: 00516882138 Page: 13 Date Filed: 09/01/2023

No. 22-40802

Finally, citing the purpose statement that appears in the Act, FDA

also argues that its mission is to protect the public health. But “no legislation

pursues its purposes at all costs.”29 That is why “statements of purpose . . .

cannot override a statute’s operative language.”30 Nothing in the Act’s plain

text authorizes FDA to issue medical advice or recommendations. FDA’s

argument from the Act’s purpose statement thus leads nowhere. In sum,

while FDA cites plenty of statutory authority allowing it to issue information,

it never identifies even colorable authority allowing it to make medical

recommendations (at least not without notice and comment). The Doctors can

therefore use the ultra vires exception to sue the Agencies and the Officials—

even if FDA is correct that the heightened, merits-adjacent test for common-

law ultra vires claims also applies to ultra vires claims under the APA.31

2

Section 702 of “[t]he APA generally waives the Federal

Government’s immunity from a suit ‘seeking relief other than money

damages and stating a claim that an agency or an officer or employee thereof

acted or failed to act in an official capacity or under color of legal

authority.’”32 When a plaintiff uses the APA to assert a “non-statutory

cause of action”—such as an ultra vires claim—section 702 “contains two

_____________________

29

Rodriguez v. United States, 480 U.S. 522, 525–26 (1987) (per curiam).

30

Sturgeon v. Frost, 139 S. Ct. 1066, 1086 (2019) (alteration adopted) (internal

quotation marks and citation omitted).

31

The Doctors have identified at least one argument that is strong enough to bypass

immunity under the common-law ultra vires doctrine (and therefore under the APA, too,

even if FDA is correct that ultra vires claims under the APA face the same hurdle as

common-law claims). Therefore, we need not and do not consider the merits of any of the

Doctors’ remaining ultra vires arguments—such as their argument under 21 U.S.C. § 396.

32

Match-E-Be-Nash-She-Wish Band of Pottawatomi Indians v. Patchak, 567 U.S. 209,

215 (2012) (quoting 5 U.S.C. § 702) (emphasis added).

13

Case: 22-40802 Document: 00516882138 Page: 14 Date Filed: 09/01/2023

No. 22-40802

separate requirements for establishing a waiver of sovereign immunity.” 33

“First, the plaintiff must identify some ‘agency action’ affecting him in a

specific way . . . .”34 The action need not be final.35 “Second, the plaintiff

must show that he has ‘[been] . . . adversely affected or aggrieved by that

action . . . .”36 To satisfy this second requirement, “the plaintiff must

establish that the injury he complains of falls within the ‘zone of interests’

sought to be protected by the statutory provision whose violation forms the

legal basis for his complaint.”37 The Doctors’ suit satisfies both

requirements.

i

The Posts are “agency action.” Under the APA, that term “includes

the whole or a part of an agency rule, order, license, sanction, relief, or the

equivalent or denial thereof, or failure to act.”38 “Rule,” in turn—

means the whole or a part of an agency statement of general or

particular applicability and future effect designed to

implement, interpret, or prescribe law or policy or describing

the organization, procedure, or practice requirements of an

agency and includes the approval or prescription for the future

of rates, wages, corporate or financial structures or

reorganizations thereof, prices, facilities, appliances, services

_____________________

33

Alabama-Coushatta, 757 F.3d at 489 (citing Lujan v. Nat’l Wildlife Fed’n, 497

U.S. 871, 882 (1990)).

34

Id.

35

See id. (citing Trudeau v. Fed. Trade Comm’n, 456 F.3d 178, 187 (D.C. Cir. 2006)).

36

Id.

37

Louisiana, 948 F.3d at 321 (alteration adopted) (internal quotation marks

omitted) (quoting Lujan, 497 U.S. at 883).

38

5 U.S.C. § 551(13).

14

Case: 22-40802 Document: 00516882138 Page: 15 Date Filed: 09/01/2023

No. 22-40802

or allowances therefor or of valuations, costs, or accounting, or

practices bearing on any of the foregoing[.]39

In other words, “[t]he APA defines the term ‘rule’ broadly enough to

include virtually every statement an agency may make.” 40 Agency rules fall

into one of two categories: either substantive or non-substantive.41 As distinct

from substantive rules, “[n]on-substantive rules are those exempted from the

notice-and-comment requirement because they lack the force of law.”42

Non-substantive rules “include rules governing internal agency organization

or procedures; non-binding agency policy statements; and guidance

documents interpreting existing rules.”43 The Posts did not go through

notice-and-comment, so if they are APA “rules” at all, it is only because they

are non-substantive rules. The Doctors argue that the Posts are rules—and

thus “agency action”—under these definitions. We agree.

FDA does not dispute that the Posts are statements, and it does not

deny authoring them. “Though there is room for disagreement about

precisely what satisfies the definition of ‘rule,’” we conclude that the Posts

easily qualify.44 Foremost, the Posts “announce [a] principle[] of general

applicability and future effect.”45 FDA’s Posts contain information, but they

also contain the generally-applicable principle that consumers “Should Not

_____________________

39

5 U.S.C.§ 551(4).

40

Avoyelles Sportsmen’s League, Inc. v. Marsh, 715 F.2d 897, 908 (5th Cir. 1983); see

F.T.C. v. Standard Oil Co. of Ca., 449 U.S. 232, 238 n.7 (1980) (similar).

41

Walmart Inc. v. U.S. Dep’t of Justice, 21 F.4th 300, 308 (5th Cir. 2021).

42

Id. On the other hand, “[s]ubstantive rules have the force of law, meaning that

they bind the regulated public.” Id.

43

Id.

44

See Walmart, 21 F.4th at 308.

45

Id. (citing 5 U.S.C. § 551(4)).

15

Case: 22-40802 Document: 00516882138 Page: 16 Date Filed: 09/01/2023

No. 22-40802

Use Ivermectin to Treat or Prevent COVID-19.” That principle aims to

curb future action—not just label past action. The day after FDA issued the

first “horse” message, FDA staffers noted that it was “the most popular

post we’ve ever had on Twitter” and that they were “pleased with the

response and the results.” Staffers also described the Posts as part of a “new

recommended approach” that comprised an “ambitio[us] effort to counter

much of the vaccine [mis]information out there.” The Posts directed

consumers to take specific actions in keeping with the generally applicable

principle that FDA had settled on and announced. That is “action” enough.

We find further support for this conclusion in Walmart Inc. v. U.S.

Department of Justice.46 There, a panel of this court held that an agency’s

“negotiating position” was not a non-substantive rule, and thus was not

agency action, because (among other things) it did not “announce agency

views to the public.”47 Furthermore, the plaintiff in that case “point[ed] to

no rule, guidance, or other public document setting forth the positions it

s[ought] to contest.”48 Here, by contrast, FDA has announced that the

public should, among other things, “Stop it with the #ivermectin.” That

recommendation is a position that the Doctors wish to contest. The Posts

reflecting the position are exactly the kind of “non-binding agency policy

statement[]” that Walmart treated as a non-substantive rule.49

FDA argues that the Posts are “informational statements” that

cannot qualify as rules because they “do not ‘direct’ consumers, or anyone

_____________________

46

21 F.4th 300, 308 (5th Cir. 2021).

47

Id. at 309 (citing Brown Express, Inc. v. United States, 607 F.2d 695, 700–01 (5th

Cir. 1979)); see Phillips Petroleum Co. v. Johnson, 22 F.3d 616, 619–20 (5th Cir. 1994)).

48

Id. at 305.

49

Id. at 308.

16

Case: 22-40802 Document: 00516882138 Page: 17 Date Filed: 09/01/2023

No. 22-40802

else, to do or refrain from doing anything.” We are not convinced. As

discussed above, each of the Posts contains imperative elements that go

beyond mere factual communication. FDA also argues that the Posts cannot

be rules because they do not “prescribe . . . policy.” Again, we disagree.

FDA concedes that the Posts “generally recommended that consumers not

take ivermectin to prevent or treat COVID-19.” For purposes of

determining non-final agency action, we do not see any daylight between an

agency that uses imperative language in recommending a general course of

action and an agency that uses imperative language in prescribing a policy.

FDA also argues that the Posts are not rules because they are

nonbinding, and because they did not mark the end of the agency’s decisional

process. But these arguments conflate the test for determining action with the

test for determining finality. Our caselaw recognizes that “nonfinal action”

is still action.50 Otherwise “final” would have no meaning (since all “agency

action” would be final by definition). Instead, we have held that, “when

judicial review is sought pursuant to a . . . non-statutory cause of action that

arises completely apart from the general provisions of the APA[,] . . . . [t]here

is no requirement of ‘finality’” for the § 702 “waiver to apply.”51 So it is

here. The Doctors’ ultra vires claim is a non-statutory cause of action. We

reject FDA’s attempt to impose a finality requirement for a waiver of

sovereign immunity in this context. And we therefore conclude that the Posts

qualify as “agency action.”

ii

The Doctors are also within the zone of interests that the Act protects.

The phrase “zone of interests” appears most often in cases discussing

_____________________

50

Qureshi v. Holder, 663 F.3d 778, 781 (5th Cir. 2011).

51

Alabama-Coushatta, 757 F.3d at 489.

17

Case: 22-40802 Document: 00516882138 Page: 18 Date Filed: 09/01/2023

No. 22-40802

prudential standing,52 and it has also popped up in cases discussing whether

the plaintiff has a cause of action.53 But we know of only a single case from

this circuit applying the zone-of-interests test in the sovereign-immunity

context: Louisiana v. United States.54 That case relied on Lujan—a leading

case on standing.55 From that reliance, we surmise that “zone of interests”

means the same thing regardless of whether the context is prudential

standing, causes of action, or sovereign immunity. At the same time, we also

acknowledge that the “zone of interests” question is distinct from

constitutional standing under Article III, and from a case’s merits.

The zone-of-interests test “is not especially demanding.” 56 “[I]n

keeping with Congress’s evident intent when enacting the APA to make

agency action presumptively reviewable,” the Supreme Court has “not

require[d] any indication of congressional purpose to benefit the would-be

plaintiff.”57 Instead, “[t]he test is satisfied if the claims are ‘arguably within

the zone of interests to be protected . . . by the statute.’”58 “The Supreme

Court has ‘always conspicuously included the word arguably in the test to

indicate that the benefit of any doubt goes to the plaintiff.’”59 “Review is

_____________________

52

E.g., Lexmark Int’l, Inc. v. Static Control Components, Inc., 572 U.S. 118, 127

(2014).

53

E.g., Tenth St. Residential Ass’n v. City of Dallas, 968 F.3d 492, 499 (5th Cir.

2020).

54

948 F.3d 317 (5th Cir. 2020).

55

See id. at 321 (citing 497 U.S. 871).

56

Texas v. United States, 50 F.4th 498, 520 (5th Cir. 2022) (internal quotation

marks and citation omitted).

57

Patchak, 567 U.S. at 225.

58

Texas, 50 F.4th at 520 (quoting Patchak, 567 U.S. at 224).

59

Id. (emphases added) (quoting Patchak, 567 U.S. at 225).

18

Case: 22-40802 Document: 00516882138 Page: 19 Date Filed: 09/01/2023

No. 22-40802

foreclosed ‘only when a plaintiff’s interests are so marginally related to or

inconsistent with the purposes implicit in the statute that it cannot reasonably

be assumed that Congress intended to permit the suit.’”60

Section 396 is titled “Practice of medicine,” and its plain text protects

some aspects of the “practitioner–patient relationship” from FDA’s

“limit[ation] or interfere[nce].”61 As practitioners themselves, the Doctors’

“interests” in the Act’s “purposes” are much more than “marginal[].” 62

Indeed, the Act expressly shields the Doctors from certain kinds of FDA

meddling. Whether that shield protects them from this alleged meddling is a

merits question—not a zone-of-interests question. Likewise, even if the

Doctors lack a cognizable injury under Article III of the Constitution, their

claims are still at least “arguably”63 within the Act’s zone of interests.

FDA does little to contest this conclusion. It does not even address

this kind of ultra vires claim in a separate section of its brief. Instead, FDA

obfuscates. It treats a non-statutory cause of action under the APA (that is,

an ultra vires claim that uses the APA as a vehicle to sue an agency)

identically to a cause of action under the APA’s general provisions. But

Alabama-Coushatta instructs that these are actually “two distinct types of

claims.”64 Here, because the Posts are agency action, and because the

Doctors are within the Act’s zone of interests, they can use the APA as a

vehicle to assert their ultra vires claims against the Agencies.

_____________________

60

Id. (internal quotation marks omitted) (quoting Patchak, 567 U.S. at 225).

61

21 U.S.C. § 396.

62

Texas, 50 F.4th at 520 (internal quotation marks and citation omitted).

63

Texas, 50 F.4th at 520 (quoting Patchak, 567 U.S. at 224).

64

Alabama-Coushatta, 757 F.3d at 489.

19

Case: 22-40802 Document: 00516882138 Page: 20 Date Filed: 09/01/2023

No. 22-40802

B

As for the Doctors’ common-law ultra vires claim, we begin by noting

that, under our precedent, Congress apparently “d[id] away with the ultra

vires doctrine and other fictions surrounding sovereign immunity” when it

amended the APA in 1976.65 We also note the D.C. Circuit’s recent decision

holding that common-law ultra vires claims are available only when there is

no alternative procedure for review.66 Similarly, the Ninth Circuit has held

that common law ultra vires claims are available only when APA ultra vires

claims are not.67 Moreover, several other circuit courts have applied the

common-law doctrine only when APA review was unavailable.68 Here,

because the Doctors can use the APA to assert their ultra vires claims, we

decline to consider whether the Doctors might also be able to assert their

ultra vires claims using only the common law version of that doctrine.

C

While the APA allows the Doctors to assert their ultra vires claims

against both the Agencies and the Officials, we conclude that the Doctors

cannot rely solely on “the general provisions of the APA.”69

“[W]hen judicial review is sought pursuant only to the general

provisions of the APA,” a plaintiff who wishes to establish “that there was a

waiver of sovereign immunity” must show that it has “suffer[ed] legal

_____________________

65

Geyen v. Marsh, 775 F.2d 1303, 1307 (5th Cir. 1985).

66

See Fed. Express Corp. v. U.S. Dep’t Commerce, 39 F.4th 756, 763 (D.C. Cir. 2022).

67

E.V. v. Robinson, 906 F.3d 1082, 1092–93 (9th Cir. 2018).

68

See, e.g., Dotson v. Griesa, 398 F.3d 156, 177 & n.15 (2d Cir. 2005); Made in the

USA Found. v. United States, 242 F.3d 1300, 1308–09 n.20 (11th Cir. 2001); Strickland v.

United States, 32 F. 4th 311, 366 (4th Cir. 2022).

69

Alabama-Coushatta, 757 F.3d at 489 (emphasis added).

20

Case: 22-40802 Document: 00516882138 Page: 21 Date Filed: 09/01/2023

No. 22-40802

wrong” because of “final agency action.”70 “There are two requirements”

for finality.71 First, “the action must mark the consummation of the agency’s

decisionmaking process—it must not be of a merely tentative or interlocutory

nature.”72 Second, “the action must be one by which rights or obligations

have been determined, or from which legal consequences will flow.” 73

The Doctors have not plausibly established the finality test’s second

prong, which requires them to show that FDA’s actions “determined rights,

produced obligations, or caused legal consequences.” 74 “The Supreme

Court has long taken a pragmatic approach to finality, viewing the APA’s

finality requirement as flexible.”75 The Doctors offer three reasons that the

Posts are final. Yet even under the Supreme Court’s “pragmatic” approach,

we cannot conclude that the Posts plausibly determined “rights or

obligations,” or that they plausibly constituted action “from which legal

consequences will flow.”76 As a result, the Posts are not final agency action.

First, quoting the panel decision in Texas v. EEOC, the Doctors say

that “[w]hat matters is whether the [action] has practical binding effect such

that affected private parties are reasonably led to believe that failure to

_____________________

70

Id. (emphases added) (internal quotation marks omitted) (first citing 5 U.S.C.

§ 702, then citing Lujan, 497 U.S. at 882).

71

Data Mktg. P’ship, LP v. United States Dep’t of Lab., 45 F.4th 846, 853 (5th Cir.

2022).

72

Id. (internal quotation marks and citation omitted).

73

Id. (internal quotation marks and citation omitted).

74

Data Mktg., 45 F.4th at 854.

75

Texas v. Equal Emp. Opportunity Comm’n, 933 F.3d 433, 441 (5th Cir. 2019)

(alteration adopted) (internal quotation marks and citations omitted) (“EEOC”); see

Qureshi, 663 F.3d at 781 (similar).

76

Data Mktg., 45 F.4th at 853 (internal quotation marks and citation omitted).

21

Case: 22-40802 Document: 00516882138 Page: 22 Date Filed: 09/01/2023

No. 22-40802

conform will bring adverse consequences.”77 But EEOC is not as broad as the

Doctors contend. The sentence they quote was elaborating on the sentence

that preceded it: “That the agency’s action binds its staff or creates safe

harbors demonstrates that legal consequences flow from it . . . .”78 The

“practical binding effect,” then, is an effect on the agency—not the public.

The sentence that follows the Doctors’ quote makes this abundantly clear:

“Defendants do not dispute that the Guidance binds EEOC, and for good

reason.”79 So too for the Doctors’ argument based on the word “norm.”

While that word also appears in the EEOC case, it refers to an “agency’s

action [that] binds it”—that is, the agency—not an action that binds others.80

The Posts do not “bind[] [FDA] and its staff to a legal position,” so they are

not norms, and their practical effect cannot carry the day.81

Second, the Doctors argue that “FDA has created a legal standard

that governing entities are regularly relying on to establish the appropriate

medical care and dictate the practice of medicine, including by courts in legal

proceedings.” Whatever else the Posts may be, dubbing them a “legal

standard” goes too far. None of the cases that the Doctors cite treated

FDA’s views as a legal standard. Instead, some courts have relied on the

Posts as factual evidence of FDA’s views. For example, a Pennsylvania

appellate court wrote that “multiple national health organizations, including

the FDA, AMA, and WHO, have advocated against the use of ivermectin

to treat COVID-19 based on the absence of conclusive studies to show

_____________________

77

EEOC, 933 F.3d at 442 (emphasis added) (internal quotation marks and citation

omitted).

78

Id. (emphasis added).

79

Id. at 443 (emphasis added).

80

Id. (emphasis added).

81

Id. at 441.

22

Case: 22-40802 Document: 00516882138 Page: 23 Date Filed: 09/01/2023

No. 22-40802

ivermectin is effective at treating COVID-19.”82 That is a statement of fact,

not law. The Doctors have not identified any court decision that treated any

of the Posts as a legal standard rather than factual evidence. And even if they

had, we conclude that FDA’s Posts do not set forth a legal standard.

Third, quoting the panel decision in Louisiana State v. U.S. Army

Corps of Engineers, the Doctors emphasize that the Posts “tend to expose

parties to civil or criminal liability for noncompliance with the agency’s view

of the law.”83 But the Doctors emphasize the wrong words—it is the last four

that matter most. No post contains FDA’s “view of the law.”84 Whether or

not the Posts play a role in exposing the Doctors to legal consequences, that

exposure does not trace to any of FDA’s legal views. This argument, like the

first two, does not show that the Posts “determined rights, produced

obligations, or caused legal consequences.”85

The Doctors respond that “legally binding effects are not necessary

to render agency action ‘final’ . . . when the action in question is clearly

outside the agency’s statutory authority and further prohibited by statute.”

The Doctors do not elaborate on this theory, nor do they support it with any

citation, so we need not address it further. Even were we inclined to consider

the theory, we would likely reject it as conflating an ultra vires claim with a

claim solely under the APA’s general provisions. After all, “clearly outside

the agency’s statutory authority” is a pretty good definition of ultra vires.

Even though the Posts are “action,” they are not action “by which

rights or obligations have been determined, or from which legal consequences

_____________________

82

Shoemaker v. UPMC Pinnacle Hosps., 283 A.3d 885, 895 (Pa. Super. Ct. 2022).

83

834 F.3d at 583 (emphasis added by the Doctors).

84

Id.

85

Data Marketing, 45 F.4th at 854.

23

Case: 22-40802 Document: 00516882138 Page: 24 Date Filed: 09/01/2023

No. 22-40802

will flow.”86 While courts and other institutions may have treated FDA’s

views as relevant factual evidence—and may have treated the Posts as

containing those views—the Posts themselves do not contain FDA’s “view

of the law.” 87 They therefore lack finality, and that means that the Doctors’

pure APA claim cannot overcome the defendants’ sovereign immunity.

IV

Last, FDA urges us to affirm on the alternative basis that the Doctors

lack standing under Article III. The district court’s dismissal was final, so we

have discretion to affirm on any basis that the record supports—including

lack of standing.88 Here, however, we see greater wisdom in remanding for

the district court to address standing and any other jurisdictional issues in the

first instance. We express no view on those issues, and instead we trust their

initial determination to the district court’s sound judgment.

V

FDA is not a physician. It has authority to inform, announce, and

apprise—but not to endorse, denounce, or advise. The Doctors have

plausibly alleged that FDA’s Posts fell on the wrong side of the line between

telling about and telling to. As such, the Doctors can use the APA to assert

their ultra vires claims against the Agencies and the Officials.

Even tweet-sized doses of personalized medical advice are beyond

FDA’s statutory authority. We REVERSE the district court’s judgment of

dismissal, and we REMAND for further proceedings.

_____________________

86

Id. at 853.

87

Louisiana State, 834 F.3d at 583 (emphasis added).

88

See Walmart, 21 F.4th at 307 (“Though the district court relied exclusively on

sovereign immunity, [we] may affirm dismissal for any reason supported by the record.”).

24