Memorandum Opinion and Order — Motion to Dismiss Granted — Apter v. HHS (Dec. 6, 2022) (S.D. Tex.)

Record facts

U.S. District Court for the Southern District of Texas, Galveston Division · No. 3:22-cv-00184 · Doc. 45 · 2022-12-06 · Docket on CourtListener

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In the United States District Court 
for the Southern District of Texas 
GALVESTON DIVISION  
═══════════ 
No. 3:22-cv-184 
═══════════ 
 
ROBERT APTER, ET AL., PLAINTIFFS, 
 
v. 
 
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, ET AL., 
DEFENDANTS. 
 
══════════════════════════════════════════ 
MEMORANDUM OPINION AND ORDER 
══════════════════════════════════════════ 
 
JEFFREY VINCENT BROWN, UNITED STATES DISTRICT JUDGE: 
The defendants have moved to dismiss under Federal Rules of Civil 
Procedure 12(b)(1) and 12(b)(6). Dkt. 25. The motion is granted.  
 
Background 
The plaintiffs, Robert L. Apter, Talley Bowden, and Paul E. Marik, have 
sued the Department of Health and Human Services; Xavier Becerra, in his 
official capacity as Secretary of Health and Human Services; the Food and 
Drug Administration; and Robert M. Califf, in his official capacity as 
Commissioner of Food and Drugs. Dkt. 12. They allege that the Food and 
Drug Administration (“FDA”) has illegally interfered with the practice of 
United States District Court
Southern District of Texas
ENTERED
December 06, 2022
Nathan Ochsner, Clerk
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medicine. Id. ¶¶ 1–9. 
The three plaintiffs are physicians who claim they have been harmed 
by the FDA’s statements on the use of ivermectin to treat COVID-19. Dkt. 12 
¶¶ 4, 10, 106. The plaintiffs specifically point to six publications by the FDA:  
(1) 
An article entitled Why You Should Not Use Ivermectin to 
Treat or Prevent COVID-19. Dkt. 12-1; 
 
(2) 
An ivermectin FAQ that asks, “Should I take ivermectin to 
prevent or treat COVID-19?” and answers, “No. While 
there are approved uses for ivermectin in people and 
animals, it is not approved for the prevention or treatment 
of COVID-19. You should not take any medicine to treat or 
prevent COVID-19 unless it has been prescribed to you by 
your health care provider and acquired from a legitimate 
source. A recently released research article . . . described 
the effect of ivermectin on SARS-CoV-2 in a laboratory 
setting. These types of laboratory studies are commonly 
used at an early stage of drug development. Additional 
testing is needed to determine whether ivermectin might 
be appropriate to prevent or treat coronavirus or COVID-
19.” Dkt. 12-2; 
 
(3) 
A COVID-19 FAQ that asks, “Should I take ivermectin to 
prevent or treat COVID-19?” and answers, “No. While 
there are approved uses for ivermectin in people and 
animals, it is not approved or authorized for the prevention 
or treatment of COVID-19. Read more about why you 
should not use ivermectin to treat or prevent COVID-19,” 
and links to the article in (1). Dkt. 12-3; 
 
(4) 
A tweet/LinkedIn post/Facebook post that reads, “You are 
not a horse. You are not a cow. Seriously, y’all. Stop it,” and 
links to the article in (1). Dkt. 12-4; 
 
(5) 
An Instagram post of a horse with the caption, “You are not 
a horse. Stop it with the #ivermectin. It’s not authorized for 
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treating #COVID.” Dkt. 12-6; and 
 
(6) 
A tweet that reads, “Hold your horses, y’all. Ivermectin may 
be trending, but it still isn’t authorized or approved to treat 
COVID-19,” and links to the article in (1). Dkt. 12-7. 
 
While the plaintiffs acknowledge the FDA’s authority to regulate drugs, 
they claim that the FDA has no authority to “prohibit, direct, or advise 
against off-label1 uses of drugs approved for human use.” Dkt. 12 ¶¶ 51–53. 
The plaintiffs rely on 21 U.S.C. § 396, which states that nothing in the Federal 
Food, Drug, and Cosmetic Act2 “shall be construed to limit or interfere with 
the authority of a health care practitioner to prescribe or administer any 
legally marketed device for any condition or disease within a legitimate 
health care practitioner-patient relationship.” Id. ¶ 56. They claim that § 396 
also applies to the prescription and administration of drugs. Id. ¶ 57. 
The plaintiffs assert five claims for relief: (1) ultra vires acts; (2) APA3 
violation: arbitrary or capricious; (3) APA violation: not in accordance with 
law; (4) APA violation: in excess of statutory authority; and (5) declaratory 
judgment in accordance with claims 1–4. Dkt. 12 ¶¶ 129–159. 
 
1 When a doctor prescribes an FDA-approved drug for a purpose different 
than that which it was approved for, it is considered “off-label.” 
2 21 U.S.C. § 301 et seq. 
3 The Administrative Procedure Act, 5 U.S.C. § 501 et seq. 
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The defendants have moved to dismiss under Rules 12(b)(1) and 
12(b)(6).4 Dkt. 25. 
 
Legal Standard 
Rule 12(b)(1) requires dismissal if the court “lacks the statutory or 
constitutional power to adjudicate the case.” Home Builders Ass’n of Miss., 
Inc. v. City of Madison, 143 F.3d 1006, 1010 (5th Cir. 1998). The party 
asserting jurisdiction bears the burden of proof. Howery v. Allstate Ins. Co., 
243 F.3d 912, 916 (5th Cir. 2001). To test whether the party asserting 
jurisdiction has met its burden, a court may rely upon: “(1) the complaint 
alone; (2) the complaint supplemented by undisputed facts evidenced in the 
record; or (3) the complaint supplemented by undisputed facts plus the 
court’s resolution of disputed facts.” Barrera–Montenegro v. United States, 
74 F.3d 657, 659 (5th Cir. 1996). In considering a motion to dismiss for lack 
of subject-matter jurisdiction, the court accepts all factual allegations in the 
plaintiffs’ complaint as true. Den Norske Stats Oljeselskap As v. HeereMac 
Vof, 241 F.3d 420, 424 (5th Cir. 2001).  
 
4 Because the jurisdictional grounds are dispositive, the court does not reach 
the merits under 12(b)(6). 
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 Analysis 
“It is axiomatic that the United States may not be sued without its 
consent and that the existence of consent is a prerequisite for jurisdiction.” 
United States v. Mitchell, 463 U.S. 206, 212 (1983). “A waiver of sovereign 
immunity cannot be implied but must be unequivocally expressed.” United 
States v. Mitchell, 445 U.S. 535, 538 (1980) (quoting United States v. King, 
395 U.S. 1, 4 (1969)). “[T]he United States may not be sued except to the 
extent that it has consented to suit by statute,” and “[w]here the United 
States has not consented to suit or the plaintiff has not met the terms of the 
statute, the court lacks jurisdiction and the action must be dismissed.” 
Alabama-Coushatta Tribe of Tex. v. United States, 757 F.3d 484, 488 (5th 
Cir. 2014) (quoting Koehler v. United States, 153 F.3d 263, 266 (5th Cir. 
1998)). “[A] waiver of the Government’s sovereign immunity will be strictly 
construed, in terms of its scope, in favor of the sovereign.” Lane v. Pena, 518 
U.S. 187, 192 (1996). 
One way for plaintiffs to overcome sovereign immunity is claiming an 
ultra vires act. Where an “officer’s powers are limited by statute, his actions 
beyond those limitations are considered individual and not sovereign 
actions”; they are instead “ultra vires his authority and therefore may be 
made the object of specific relief.” Danos v. Jones, 652 F.3d 577, 583 (5th 
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Cir. 2011) (quoting Larson v. Domestic & Foreign Com. Corp., 337 U.S. 682, 
689 (1949)). To successfully claim an ultra vires act, “the complaint must 
allege facts sufficient to establish that the officer was acting ‘without any 
authority whatever,’ or without any ‘colorable basis for the exercise of 
authority.’” Danos, 652 F.3d at 583 (quoting Pennhurst State Sch. & Hosp. 
v. Halderman, 465 U.S. 89, 101 n.11 (1984)). The ultra vires doctrine is a 
narrow exception to sovereign immunity. Pennhurst State Sch. & Hosp., 465 
U.S. at 116. 
The APA provides another opportunity for plaintiffs to overcome 
sovereign immunity. “Section 702 of the APA ‘waives sovereign immunity for 
actions against federal government agencies, seeking nonmonetary relief, if 
the agency conduct is otherwise subject to judicial review.’” Louisiana v. 
United States, 948 F.3d 317, 321 (5th Cir. 2020) (quoting Alabama-
Coushatta Tribe, 757 F.3d at 488). To seek judicial review, § 702 requires the 
plaintiffs to meet two requirements.   
First, the plaintiffs must identify an agency action. Lujan v. Nat’l 
Wildlife Fed’n, 497 U.S. 871, 882 (1990); 5 U.S.C. § 702. Agency action is 
defined by 5 U.S.C. § 551(13) to “include[] the whole or a part of an agency 
rule, order, license, sanction, relief, or the equivalent or denial thereof, or 
failure to act.” 5 U.S.C. § 551(13); see 5 U.S.C. § 701(b)(2) (“For the purpose 
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of this chapter . . . ‘agency action’ ha[s] the meaning[] given . . . by section 
551 of this title.”).  
Second, the plaintiffs “must show that [they have] ‘suffered legal 
wrong’ because of the challenged agency action, or are ‘adversely affected or 
aggrieved’ by that action ‘within the meaning of a relevant statute.’” Lujan, 
497 U.S. at 883.  
While these two requirements apply to all waivers of sovereign 
immunity under § 702, the APA distinguishes between two different types of 
claims: (1) causes of action under the general provisions of the APA, “where 
a ‘person suffer[s] legal wrong because of the agency action,’” and 
(2) statutory and non-statutory causes of action, “where a person is 
‘adversely affected or aggrieved by agency action within the meaning of a 
relevant statute.’” Alabama-Coushatta Tribe, 757 F.3d at 489 (quoting 5 
U.S.C. § 702). “[T]o be ‘adversely affected or aggrieved . . . within the 
meaning’ of a statute, the plaintiff[s] must establish that the injury . . . falls 
within the ‘zone of interests’ sought to be protected by the statutory provision 
whose violations forms the legal basis for his complaint.” Lujan, 497 U.S. at 
883. 
“When . . . review is sought . . . under the general review provisions of 
the APA, the ‘agency action’ . . . must be ‘final agency action.’” Id. at 882 
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(emphasis added) (quoting 5 U.S.C. § 704). To be a final agency action, the 
action must “(1) ‘mark the consummation of the agency’s decisionmaking 
process,’ and (2)” be an action “by which rights or obligations have been 
determined, or from which legal consequences will flow.” Sierra Club v. 
Peterson, 228 F.3d 559, 565 (5th Cir. 2000) (quoting Bennett v. Spear, 520 
U.S. 154, 178 (1997)). “A final action must be an ‘identifiable action or event.’” 
Id. (quoting Lujan, 497 U.S. at 899).  
In contrast, when review is sought pursuant to a statutory or non-
statutory cause of action—completely apart from the general provisions of 
the APA—there is no finality requirement; the plaintiff need only show 
“agency action” within the meaning of 5 U.S.C. § 551(10). Alabama-
Coushatta Tribe, 757 F.3d at 489.  
The court believes, and the parties seem to agree, that the plaintiffs’ 
claim in Count 1 could be analyzed under either the non-statutory claim 
standard of the APA or the ultra vires doctrine. See Dkts. 25 at 29 (labeling 
Count 1 as a non-statutory cause of action and explaining § 702’s application 
on such a claim); 27 at 30 (arguing the ultra vires claim and simultaneously 
noting that § 702 waives sovereign immunity for both ultra vires and APA 
claims). The APA and ultra vires jurisprudence, however, are two distinct 
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waivers of sovereign immunity, and thus it would be incorrect to use the two 
interchangeably.  
The court analyzes Count 1 under the ultra vires-act jurisprudence 
because the plaintiffs label it that way in their complaint, Dkt. 12 at 37, and 
because the plaintiffs emphasized that their claim under the ultra vires 
jurisprudence was separate from their claims under the APA during the 
motion hearing, Dkt. 43 at 26 (“[T]his court should be careful to . . . view the 
ultra vires claim and the APA claim separately.”). Counts 2–4 are claims 
made under the general provision of the APA. 
A. Ultra Vires Acts  
The defendants argue that the plaintiffs fail to establish subject-matter 
jurisdiction as sovereign immunity bars their claims. Dkt. 25 at 10. The 
plaintiffs respond that the statements were ultra vires and thus sovereign 
immunity does not bar their suit. Dkt. 27 at 29.  
The plaintiffs argue that the FDA’s statements were ultra vires acts 
because they exceeded the FDA’s authority as limited by 21 U.S.C. § 396. 
Dkt. 12 ¶¶ 129–131. Section 396 provides:  
Nothing 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 for any 
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condition or disease within a legitimate health care practitioner-
patient relationship.  
 
21 U.S.C. § 396 (emphasis added). 
  
The plaintiffs contend that courts have “consistently interpreted this 
prohibition as applying to the prescription or administration of drugs as 
well.” Dkt. 27 at 9. Yet as far as cases from this circuit go, they rely on just 
one that acknowledges the fact5 that “the FDA does not restrict physicians 
from prescribing an otherwise FDA-approved drug for an off-label use,” and 
then, notably, cites to § 396 using a see citation. United States ex rel King v. 
Solvay Pharm., Inc., 871 F.3d 318, 328 (2017). The Fifth Circuit’s use of “see” 
regarding § 396 does not stand for the proposition that § 396 applies equally 
to drugs as it does to devices. Indeed, the use of a see signal explicitly 
acknowledges that there is an “inferential step” required between the 
statute’s plain language and the court’s assertion. THE BLUEBOOK: A UNIFORM 
SYSTEM OF CITATION R.1.2, at 62 (Columbia Law Review Ass’n et al. eds., 21st 
ed. 2020) (explaining that a see signal is used when “there is an inferential 
step between the authority cited and the proposition it supports”). In some 
circumstances, this may be a comfortable inference for the court to make. In 
the context of an ultra vires claim, however, it is too much—the ultra vires-
 
5 The defendants do not dispute that this is generally the case. Dkts. 25 at 11; 
42 at 11. 
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act exception to sovereign immunity is intended to be narrow. Pennhurst 
State Sch. & Hosp., 465 U.S. at 116. This court will not be persuaded to rely 
on a see signal to expand the plain-text meaning of the Food, Drug, and 
Cosmetic Act and inappropriately enlarge the scope of the ultra vires-act 
exception to sovereign immunity.  
To be ultra vires, there must be (1) an officer, (2) whose powers are 
limited by statute, who (3) acted outside of those limitations. Larson, 337 
U.S. at 689. Further, the act must be without any authority whatsoever or be 
made without any colorable basis for authority. Danos, 652 F.3d at 583. That 
is not the case here. First, while § 396 limits the FDA’s powers as applied to 
medical devices, it does not do so in the context of drugs. As there is no 
statute limiting the FDA’s actions here, it cannot have acted outside of any 
statutory limitations.6  
Further, it cannot be said that the FDA had no colorable basis of 
authority. The FDA is charged by Congress with protecting public health and 
ensuring that regulated medical products are safe and effective, among other 
 
6 Perhaps if the plaintiffs were alleging that the statements interfered with 
the authority to administer or prescribe a legally marketed medical device, which 
§ 396 specifically prohibits, they would sufficiently be alleging an ultra vires act 
and the complaint could survive a motion to dismiss on those grounds. The fact of 
the matter, however, is that the statute says devices, not drugs—and this case is 
about drugs.   
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things. 21 U.S.C. §§ 393 (b)(1)–(b)(2). The plaintiffs do not dispute that the 
FDA has the authority, generally, to make public statements in-line with 
these purposes. Although the FDA could have, and perhaps should have, 
been more prudent in their communications, they had at least a colorable 
basis in authority—and there is no statute saying otherwise.  
So the complaint fails to allege an ultra vires act that would vest this 
court with subject-matter jurisdiction in the face of the defendants’ sovereign 
immunity. 
B. General APA Claims 
When a plaintiff makes a claim under the general provisions of the 
APA, the APA “provides judicial review of ‘final agency action for which there 
is no other adequate remedy in a court.’” Data Mktg. P’ship v. U. S. Dep’t of 
Labor, 45 F.4th 846, 853 (5th Cir. 2022) (quoting 5 U.S.C. § 704). To warrant 
judicial review here, the plaintiffs must allege a final agency action and “must 
show that [they have] ‘suffer[ed] legal wrong’ because of the challenged 
agency action, or [are] ‘adversely affected or aggrieved’ by that action ‘within 
the meaning of a relevant statute.’” Lujan, 497 U.S. at 882–83 (quoting 5 
U.S.C. § 702). The FDA’s statements are not final agency action.  
To be a final agency action, the action must “(1) ‘mark the 
consummation of the agency’s decisionmaking process,’ and (2) ‘by which 
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rights or obligations have been determined, or from which legal 
consequences will flow.’” Sierra Club, 228 F.3d at 565 (quoting Bennett, 520 
U.S. at 178). 
Assuming arguendo that the statements were in fact agency action, the 
plaintiffs have not alleged a waiver of sovereign immunity under the general 
provisions of the APA as the statements do not rise to the level of final agency 
action. While the finality requirement is “flexible” and “pragmatic,” the 
statements here are not final agency action. See Abbott Lab. v. Gardner, 387 
U.S. 136, 149–50 (1967)  
As to the first prong of the final-agency-action test, at least some of the 
statements do not mark the consummation of the agency’s decisionmaking 
process. “Agency action may mark the consummation of the agency’s 
decisionmaking process if the agency action ‘is not subject to further agency 
review,’ which occurs when the agency has ‘asserted its final position on the 
factual circumstances underpinning’ the agency action.” Louisiana State v. 
U.S. Army Corps of Eng’rs, 834 F.3d 574, 581 (5th Cir. 2016) (internal 
citation omitted) (quoting Sackett v. EPA, 566 U.S. 120, 127 (2012), and 
Alaska Dep’t of Envtl. Conservation v. EPA, 540 U.S. 461, 483 (2004)). 
However, an agency’s ability to simply “change its position or its reasons for 
the decision” does not alone bar finality. Data Mktg. P’ship, 45 F.4th at 854.  
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Some of the statements at issue here imply a lack of finality, as they 
include language indicating that they were made based on “[c]urrently 
available data,” “[a]dditional testing [was] needed,” “[c]linical trials [were] 
ongoing,” and “initial research [was] underway.” Dkts. 25-1 at 3; 25-2 at 2; 
25-29 at 3. Other statements, like the Instagram post, do not have this 
qualifying language and could potentially represent the consummation of the 
agency’s decisionmaking process—except that no case law establishes the 
proposition that fleeting content on social media can mark the 
consummation of an agency’s decisionmaking process. Though of course the 
FDA could revisit the statements and change its opinion, either by taking 
them down or making new statements, that alone is insufficient to prevent 
an agency action from being final. Data Mktg. P’ship, 45 F.4th at 854. The 
court will not reach that question, however, because the statements fail the 
second prong of the final-agency-action test.  
 
None of the statements determine rights, obligations, or legal 
consequences. “[L]egal consequences are created whenever the challenged 
agency action has the effect of committing the agency itself to a view of the 
law that, in turn, forces the plaintiff either to alter its conduct, or expose itself 
to potential liability.” Texas v. EEOC, 827 F.3d 372, 282 (5th Cir. 2016) 
(“EEOC I”). When considering whether agency action meets this prong of the 
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final-agency-action test, courts consider a variety of factors, including 
“whether an agency intends to bind itself to a particular legal position,” 
whether the action appears on its face to be binding or is applied in a way 
that is binding, whether there is mandatory language, whether the action 
retracts an agency’s discretion to adopt a different view of the law, whether 
the action creates safe harbors protecting parties from adverse actions, and 
when “affected private parties are reasonably led to believe that failure to 
conform will bring adverse consequences.” Texas v. EEOC, 933 F.3d 433, 
441–43 (5th Cir. 2019) (“EEOC II”).  
There is a plethora of case law that outlines when agency action is final. 
See, e.g., Louisiana State, 834 F.3d at 583 (collecting cases where agency 
action was final7); see also Data Mktg. P’ship, 45 F.4th at 854 (holding that 
an advisory opinion that bound the agency and withdrew previously held 
 
7 Among others, Louisiana State cites Bennett, 520 U.S. at 170, 178 “(noting 
that the Fish and Wildlife Service’s ‘Biological Opinion,’ which stated that the 
Bureau of Reclamation’s operation of a federal reclamation scheme threatened two 
endangered species of fish, had ‘direct and appreciable legal consequences’ 
because disregarding the Biological Opinion’s conclusions threatened the future 
prospect of substantial civil and criminal penalties)” and “Frozen Food Express v. 
United States, 351 U.S. 40, 44 (1956) (order of Interstate Commerce Commission 
was final agency action because it ‘warns every carrier, who does not have authority 
from the Commission to transport [specified] commodities, that it does so at the 
risk of incurring criminal penalties’).” Louisiana State, 834 F.3d at 583. 
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discretion was final agency action, while information letters did not bind the 
agency and were not final).  
The plaintiffs rely on EEOC II for the proposition that an agency’s 
guidance document is final for APA purposes where “private parties can rely 
on it as a norm or safe harbor by which to shape their actions.” Dkt. 27 at 33 
(quoting EEOC II, 933 F.3d at 443–44). The plaintiffs argue that this is the 
case here, as the FDA’s statements created a norm as to ivermectin use in a 
COVID-19 context, and thus the statements here are as final as the guidance 
document in EEOC II was final. Id. 
The statements here, however, are unlike the guidance documents in 
EEOC II. In EEOC II, the guidance documents announced the EEOC’s 
interpretation of law, described how the EEOC would handle fact patterns 
under that interpretation, and how affected employers, individuals, and 
EEOC staff should respond. EEOC II, 933 F.3d at 437–39. The court held 
that the guidance documents were final agency action that established rights, 
obligations or legal consequences, as the guidance told EEOC staff what was 
illegal, established a framework for employers to follow to comply with law, 
and created safe harbors for employers to avoid liability. Id. at 443–47. Thus, 
the guidance was binding as a practical matter because private parties could 
rely on it as a norm or safe harbor to shape their actions around to avoid 
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liability. Id. at 443–44. Although the EEOC did not have power to bring an 
enforcement action under the guidelines against the plaintiff State of Texas, 
the EEOC did have the power to bring such an action against a private 
employer. Id. at 444. The court determined that the finality of the action did 
not depend on the plaintiff’s identity, but on the action itself, and how the 
action binds the agency. Id. at 444–45. 
 
The FDA statements here do not come close to determining the rights, 
obligations, and legal consequences determined by the guidance in EEOC II. 
Here, there is no indication the FDA has adopted a legal position, no 
indication of any future liability on non-complying parties, and no 
establishment of safe harbors. The statements do not, in contrast to the 
EEOC II guidance, have the “effect of committing the agency itself to a view 
of the law that, in turn, forces the plaintiff to alter its conduct, or expose itself 
to potential liability.” Id. at 446 (citing EEOC I, 827 F.3d at 383). While the 
FDA statements communicate the FDA’s stance on ivermectin, they do not 
attempt to delve into the legality of any issue in the way that the EEOC II 
guidance did. Further, the FDA does not have the power to “enforce” the 
statements against the plaintiffs or anyone else, unlike in EEOC II. Thus, 
shaping behavior around the statements here would not protect the 
plaintiffs, or anyone else, from liability at the hands of the FDA. Finally, 
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unlike in EEOC II, the statements here do not bind the federal agency. The 
statements here do not outline the agency’s legal position on a doctor’s 
authority to prescribe ivermectin to patients and the possible consequences 
of doing so, or how a doctor can avoid facing liability for prescribing 
ivermectin, or use any similar language indicating that the statements 
determine rights, obligations, or legal consequences. The statements here are 
unlike the guidance documents in EEOC II and are not final agency action. 
 
The plaintiffs also rely on Louisiana State v. U.S. Army Corp of Eng’rs, 
834 F.3d 574, 583 (5th Cir. 2016), to support their contention that the FDA 
statements are final agency action. Dkt. 27 at 34. In Louisiana State, the Fifth 
Circuit held that a federal agency’s “Final Deauthorization Report,” which 
certified part of a plan but did not bind or regulate the plaintiff, did not create 
any legal consequences as required for final agency action. Louisiana State, 
834 F.3d at 583. In support of this conclusion, the court explained that final 
agency actions “normally affect a regulated party’s possible legal liability; 
these consequences tend to expose parties to civil or criminal liability for 
non-compliance with the agency’s view of the law or offer a shelter from 
liability if the regulated party complies.” Id.  
While the plaintiffs allege that the FDA’s statements have incited third 
parties to investigate and fire the plaintiffs, the FDA’s statements do not state 
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the FDA’s view of the law or create civil or criminal liability for non-
compliance, just as the report in Louisiana State did not create legal 
consequences. A state-medical-board investigation and losing one’s job—at 
the hands of non-agency third parties—are not the types of consequences 
that meet the finality requirement.  
Louisiana State also provides a contrasting point—the court in that 
case ruled that a memorandum of agreement that was binding, final, and 
contractual in nature determined “rights and obligations and ha[d] legal 
consequences,” and thus was final agency action. Id. Under the 
memorandum of agreement, the agency could have sued the plaintiff to 
enforce the terms. Id. at 584. When compared to the two different documents 
in Louisiana State, the statements here are more like the report than the 
memorandum of agreement; the FDA cannot “enforce” the statements here 
against the plaintiffs or anyone else. Like the report in Louisiana State, the 
statements here are not final agency action. 
 
The complaint has failed to allege a final agency action that would allow 
an exception to sovereign immunity under the APA.8 
* 
* 
* 
 
8 As the complaint does not allege final agency action, the court does not 
reach whether the plaintiffs suffered legal harm as a result of final agency action. 
Alabama-Coushatta Tribe, 757 F.3d at 489. 
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As the complaint does not allege facts that overcome the defendants’ 
assertion of sovereign immunity, the defendants’ motion to dismiss is 
granted. Dkt. 25. 
Signed on Galveston Island this 6th day of December, 2022. 
 
 
 
___________________________ 
JEFFREY VINCENT BROWN 
UNITED STATES DISTRICT JUDGE 
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gov.uscourts.txsd.1875135.45.0.pdf

Size

283,360 bytes

SHA-256

f672bcd7be7c449a9fb9ec8d684f764dfce64de1b4ec442b9b3b1876418890f2

Our copy

gov.uscourts.txsd.1875135.45.0.pdf

Original

archive.org