Apter v. Dept of Health & Human Svc ( 2023 )

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
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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.
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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
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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
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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]
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. . . 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
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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
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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
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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.
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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
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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.
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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.
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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).
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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).
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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)).
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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.
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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.
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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
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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).
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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.
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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
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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
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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.
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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.
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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