Court filing

Defendants' Renewed Motion to Dismiss — Apter v. HHS (Jan. 19, 2024) (S.D. Tex.)

Filed January 19, 2024 in Apter v. Department of Health and Human Services; one of 66 filings from this case.

Record facts

Court	U.S. District Court for the Southern District of Texas, Galveston Division
Filed	2024-01-19

U.S. District Court for the Southern District of Texas, Galveston Division · No. 3:22-cv-00184 · Doc. 62 · 2024-01-19 · Docket on CourtListener

Full text

UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF TEXAS
GALVESTON DIVISION

ROBERT L. APTER, et al.,

Plaintiffs,

U.S. DEPARTMENT OF HEALTH
AND HUMAN SERVICES, et al.,

Defendants.

Case No. 3:22-cv-184

JUDGE JEFFREY V. BROWN
Defendants’ Renewed Motion to Dismiss the Amended Complaint
OF COUNSEL:

SAMUEL R. BAGENSTOS
General Counsel
U.S. Department of Health and
Human Services

MARK RAZA
Chief Counsel

WENDY S. VICENTE
Deputy Chief Counsel, Litigation
Food and Drug Administration

LEAH A. EDELMAN
Associate Chief Counsel
Food and Drug Administration
BRIAN M. BOYNTON
Principal Deputy Assistant Attorney
General

ARUN G. RAO
Deputy Assistant Attorney General

AMANDA N. LISKAMM
Director

JAMES W. HARLOW
Acting Assistant Director

ISAAC C. BELFER
Attorney-In-Charge
D.C. Bar No. 1014909
OLIVER MCDONALD
Of Counsel
N.Y. Bar No. 5416789
Trial Attorneys
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Consumer Protection Branch
Civil Division
U.S. Department of Justice
P.O. Box 386
Washington, DC 20044-0386
(202) 305-7134 (Belfer)
(202) 305-0168 (McDonald)
(202) 514-8742 (fax)
Isaac.C.Belfer@usdoj.gov
Oliver.J.McDonald@usdoj.gov

Counsel for Defendants
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TABLE OF CONTENTS
INTRODUCTION ................................................................................................................... 1
BACKGROUND ..................................................................................................................... 3
I.
Factual Background ............................................................................................... 3
A.
FDA’s Critical Role in Protecting the Public Health .................................. 3
B.
The Approved Uses of Ivermectin and FDA’s Statements
Regarding the Use of Ivermectin to Prevent or Treat COVID-19 ............. 4
C.
The Plaintiffs ..................................................................................................... 8
1.
Apter ............................................................................................................... 8
2.
Bowden ........................................................................................................ 10
3.
Marik ............................................................................................................ 12
II. Procedural History .............................................................................................. 14
A.
Plaintiffs’ Amended Complaint................................................................... 14
B.
Prior Proceedings ........................................................................................... 14
LEGAL STANDARDS .......................................................................................................... 15
ARGUMENT ....................................................................................................................... 16
I.
Alleged Injuries Caused By Independent Third Parties Do Not
Support Plaintiffs’ Standing ............................................................................... 18
A.
Plaintiffs’ Allegations Are Facially Deficient ............................................ 18
B.
The Available Evidence Confirms that Plaintiffs Lack Standing ........... 20
II. Plaintiffs Continue to Prescribe and Promote Ivermectin to Prevent
or Treat COVID-19 .............................................................................................. 23
III. Plaintiffs’ Assertions Regarding “Interference” With Their
Practice of Medicine Do Not Support Standing .............................................. 24
IV. Plaintiffs’ Injuries Are Not Likely to Be Redressed by the
Requested Relief .................................................................................................. 26
CONCLUSION .................................................................................................................... 30

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TABLE OF AUTHORITIES
Cases
AIDS Healthcare Found., Inc. v. City of Baton Rouge/Par. of E. Baton Rouge,
No. 17-cv-229, 2017 WL 2899689 (M.D. La. July 7, 2017) ...................................... 25
Alabama-Coushatta Tribe of Tex. v. United States,
757 F.3d 484 (5th Cir. 2014) ........................................................................................ 16
Apter v. Dep’t of Health & Hum. Servs.,
80 F.4th 579 (5th Cir. 2023) ................................................................................ passim
Apter v. U.S. Dep’t of Health & Human Servs.,
644 F. Supp. 3d 361 (S.D. Tex. 2022) ................................................................... 14, 15
Ass’n of Am. Physicians & Surgeons v. FDA,
13 F.4th 531 (6th Cir. 2021) ......................................................................................... 24
Bennett v. Spear,
520 U.S. 154 (1997) ....................................................................................................... 19
California v. Texas,
141 S. Ct. 2104 (2021) ...................................................................................... 19, 20, 24
Clapper v. Amnesty Int’l USA,
568 U.S. 398 (2013) ..................................................................................... 17, 19, 20, 24
Ctr. for Biological Diversity v. EPA,
937 F.3d 533 (5th Cir. 2019) .................................................................................. 18, 22
Ctr. for Biological Diversity, Inc. v. BP Am. Prod. Co.,
704 F.3d 413 (5th Cir. 2013) ........................................................................................ 29
DaimlerChrysler Corp. v. Cuno,
547 U.S. 332 (2006) ................................................................................................. 16, 26
Data Marketing P’ship, LP v. U.S. Dep’t of Labor,
45 F.4th 846 (5th Cir. 2022) ................................................................................... 15, 19
Daves v. Dallas Cnty.,
22 F.4th 522 (5th Cir. 2022) ............................................................................. 18, 19, 20
Dep’t of Educ. v. Brown,
143 S. Ct. 2343 (2023) .................................................................................................. 28
El Paso Cnty. v. Trump,
982 F.3d 332 (5th Cir. 2020) .................................................................................. 26, 28
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iii

Evans v. Tubbe,
657 F.2d 661 (5th Cir. 1981) .................................................................................. 16, 21
Gill v. Whitford,
138 S. Ct. 1916 (2018) .................................................................................................. 26
Grupo Dataflux v. Atlas Glob. Grp., L.P.,
541 U.S. 567 (2004) ....................................................................................................... 30
James v. Hegar,
86 F.4th 1076 (5th Cir. 2023) ....................................................................................... 17
Kowalski v. Tesmer,
543 U.S. 125 (2004) ........................................................................................... 24, 25, 26
Med. Rsch., Inc. v. Ostroff,
670 F. App’x 450 (9th Cir. 2016) ................................................................................ 19
Mora v. Univ. of Tex. Sw. Med. Ctr.,
469 F. App’x 295 (5th Cir. 2012) ................................................................................ 23
Paterson v. Weinberger,
644 F.2d 521 (5th Cir. 1981) ........................................................................................ 16
Physicians for Integrity in Med. Rsch., Inc. v. Ostroff,
70 F. App’x 450 (9th Cir 2016) ................................................................................... 19
Powers v. Ohio,
499 U.S. 400 (1991) ................................................................................................. 25, 26
Renal Physicians Ass’n v. U.S. Dep’t of Health & Hum. Servs.,
489 F.3d 1267 (D.C. Cir. 2007).................................................................................... 27
Shurtleff v. City of Boston,
142 S. Ct. 1583 (2022) .................................................................................................... 3
Simic v. City of Chi.,
851 F.3d 734 (7th Cir. 2017) ........................................................................................ 18
Simon v. E. Ky. Welfare Rts. Org.,
426 U.S. 26 (1976) ......................................................................................................... 28
Spokeo, Inc. v. Robins,
578 U.S. 330 (2016) ........................................................................................... 16, 24, 26
Steel Co. v. Citizens for a Better Env’t,
523 U.S. 83 (1998) ................................................................................................... 16, 29
Summers v. Earth Island Inst.,
555 U.S. 488 (2009) ....................................................................................................... 19
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Superior MRI Servs., Inc. v. All. Healthcare Servs., Inc.,
778 F.3d 502 (5th Cir. 2015) ........................................................................................ 16
Sykes v. FEC,
335 F. Supp. 2d 84 (D.D.C. 2004) ............................................................................... 29
TransUnion LLC v. Ramirez,
141 S. Ct. 2190 (2021) .................................................................................................. 17
Ward v. Santa Fe Indep. Sch. Dist.,
393 F.3d 599 (5th Cir. 2004) ........................................................................................ 25
Statutes
21 U.S.C. §
321(p) .............................................................................................................................. 3
331(d) .............................................................................................................................. 3
355(a) ............................................................................................................................... 3
335(b) ............................................................................................................................... 3
355-1 ................................................................................................................................ 4
360(b) ............................................................................................................................... 3
375(b) ............................................................................................................................... 3
393(b)(1) .......................................................................................................................... 3
393(b)(2)(B) ..................................................................................................................... 3
42 U.S.C. § 242o ................................................................................................................. 3
Rules
Fed. R. Civ. P. 12(b)(1) .................................................................................................... 15
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INTRODUCTION
During the COVID-19 pandemic, the U.S. Food and Drug Administration
(“FDA”) received multiple reports of patients who required medical attention,
including hospitalization, after self-medicating with ivermectin products
intended for animals. In response, FDA posted an article on its website
explaining that drug products containing ivermectin have been approved for
certain uses in humans and that other drug products containing ivermectin have
been approved for certain uses in animals, but that they have not been approved
or authorized to prevent or treat COVID-19. The article warned consumers that it
could be dangerous for humans to use ivermectin to treat COVID-19. FDA
tweeted links to the article and communicated similar information through an
Instagram post, two FAQ pages on its website, and a letter to two organizations
(collectively, the “Statements”).
Doctors Robert L. Apter, Mary Talley Bowden, and Paul E. Marik, who
prescribed or promoted ivermectin to prevent or treat COVID-19, brought suit to
challenge FDA’s Statements. They asserted both an ultra vires claim and claims
under the general provisions of the Administrative Procedure Act (“APA”), but
the Fifth Circuit has upheld this Court’s dismissal of the latter claims. All that
remains in this case is Plaintiffs’ claim that the recommendations in the
Statements that consumers not use ivermectin to prevent or treat COVID-19 are
ultra vires.
Plaintiffs lack standing to assert that claim. On the face of the Amended
Complaint, Plaintiffs do not plausibly allege personal, concrete injuries that are
fairly traceable to any recommendations in the Statements. Plaintiffs’ alleged
injuries were caused by independent third parties, such as their employers
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allegedly forcing them to resign, and do not support standing because the third
parties’ actions were not a predictable response to any allegedly ultra vires
elements in the Statements. Furthermore, the Amended Complaint contradicts
Plaintiffs’ allegation that they were “unable to prescribe” ivermectin, and
Plaintiffs cannot show standing based on the vague allegation that FDA
interfered with the “practice of medicine” or based on alleged injuries to third
parties. Finally, Plaintiffs have not plausibly alleged redressability. A declaration
that FDA’s recommendations to consumers exceeded the agency’s authority
would not likely cause sophisticated actors in the healthcare field, such as state
medical boards and hospitals, to take any action that would remedy Plaintiffs’
alleged injuries.
In addition to their facial challenge, Defendants assert a factual challenge
and adduce evidence that confirms Plaintiffs’ lack of standing. For example, the
evidence shows that

. The evidence also shows that Bowden and Marik
voluntarily resigned their positions and that their resignations were not fairly
traceable to the Statements. Finally, the evidence confirms that none of Plaintiffs’
alleged injuries, including

or their voluntary resignations, are likely to be
redressed by the requested relief.
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BACKGROUND
I.
Factual Background
A. FDA’s Critical Role in Protecting the Public Health
The Federal Food, Drug, and Cosmetic Act (“FDCA”) regulates the
manufacturing, labeling, and distribution of drugs in the United States. 21 U.S.C.
§ 301 et seq. Under the FDCA’s comprehensive regulatory scheme, it is unlawful
to distribute a “new drug” in interstate commerce without FDA approval, which
requires the manufacturer to show that the drug is both safe and effective for its
intended uses. Id. §§ 321(p), 331(d), 355(a), (b). Similarly, the FDCA generally
makes it unlawful to distribute a “new animal drug” unless FDA approves it as
safe and effective for a particular intended use. Id. § 360(b).
Congress charged FDA with protecting the public health and ensuring the
safety and effectiveness of medical products. See 21 U.S.C. § 393(b)(1), (b)(2)(B).
In furtherance of that mission, under its inherent authority and pursuant to
various express authorities, the agency communicates with the public, including
health care providers and consumers, regarding medical products’ safety and
efficacy. See, e.g., id. § 375(b); 42 U.S.C. § 242o; cf. Shurtleff v. City of Boston, 142
S. Ct. 1583, 1589 (2022). FDA communicates directly to the public about the safety
and effectiveness of medical products through, among other things, the Federal
Register, its website, social media, direct mailings, and journals. These
communications include Drug Safety Communications, press releases, notices of
recalls, articles in scientific journals, YouTube videos, Instagram posts, and
tweets regarding safety information about human medical products on
@FDAMedWatch. See, e.g., https://perma.cc/2Z2F-SK6W (2016 recommendation
against the use of lidocaine to treat teething pain); https://perma.cc/VH86-
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UYZ6 (2017 safety communication warning of risks of a certain drug
combination).
FDA’s longstanding position is that, in general, the agency does not regulate
the practice of medicine, meaning that with certain limited exceptions, health-
care professionals may choose to prescribe or use a legally marketed human
drug for an unapproved use (sometimes referred to as “off-label” use) when they
judge that the unapproved use is medically appropriate for an individual
patient.1
B. The Approved Uses of Ivermectin and FDA’s Statements Regarding
the Use of Ivermectin to Prevent or Treat COVID-19
Drug products containing ivermectin as the active ingredient are approved
to treat parasites and certain skin conditions in humans. Am. Compl. ¶ 74. FDA
has also approved different drug products containing ivermectin to treat certain
parasites in various animal species and to prevent heartworm disease in some
small animal species, with dosages and formulations that vary based on the
species and the condition to be treated.2 See, e.g., Ex. 2 at 2.3

1 In certain circumstances, FDA imposes restrictions on prescribing approved
drugs. See, e.g., 21 U.S.C. § 355-1 (authorizing FDA to require formal plans for
certain drugs to help ensure that those drugs’ benefits outweigh their risks).
2 See, e.g., Am. Compl. ¶ 75 (citing Zimecterin Gold, which is approved for
use in horses). The labeling for Zimecterin Gold warns that the product is “[n]ot
for use in humans” and “should not be used in other animal species” because
“severe adverse reactions,” including death, could result.
https://go.usa.gov/xSM8F.
3 Citations to numbered exhibits refer to the exhibits to the Amended
Complaint. Unless otherwise indicated, cited page numbers refer to the page
numbers assigned by CM-ECF.
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During the COVID-19 pandemic, FDA received multiple reports of patients
who required medical attention, including hospitalization, after self-medicating
with ivermectin products intended for animals. Exs. 1 at 3; 19 at 2. In response,
FDA made public statements warning consumers about the risks of using
ivermectin to prevent or treat COVID-19. The Amended Complaint identifies
seven Statements: an article and two FAQs posted on FDA’s website, Exs. 1–3, 19;
two tweets linking to the article, Exs. 4, 7; an Instagram post, Ex. 6; and a letter to
two organizations, Ex. 22. See Am. Compl. ¶ 4. None of the Statements
recommended or instructed doctors not to prescribe ivermectin products to
prevent or treat COVID-19 or pharmacies not to fill prescriptions for ivermectin.
The article, titled “Why You Should Not Use Ivermectin to Treat or Prevent
COVID-19,” was first posted on March 5, 2021. Ex. 19. It was directed to
consumers. See id. at 3 (“Never use medications intended for animals on
yourself.”). It noted the “growing interest” in using ivermectin to treat COVID-19
but that FDA “ha[d] not reviewed data to support [this] use of ivermectin” and
“ha[d] not approved ivermectin” for this use. Id. at 2. It warned that using a
COVID-19 treatment that is “not approved or authorized by the FDA, unless part
of a clinical trial, can cause serious harm.” Id. It explained that ivermectin could
be dangerous if, for example, it “interact[s] with other medications,” and advised
that “[i]f you have a prescription for ivermectin for an FDA-approved use, get it
from a legitimate source and take it exactly as prescribed.” Id. at 3.
That version of the article was replaced on September 7, 2021, with a version
that removed the statement that FDA had not yet “reviewed data to support [the]
use of ivermectin” to prevent or treat COVID-19 and instead emphasized that
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FDA has not approved ivermectin to prevent or treat COVID-19 or granted
emergency use authorization for that use. Ex. 1 at 2. The article advised, “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.” Id. at 3
(emphasis in original). And the article recommended: “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.” Id.
at 4 (emphasis added).
FDA publicized its article on Twitter with tweets linking to the article. For
example, an August 21, 2021 tweet stated, “You are not a horse. You are not a
cow. Seriously, y’all. Stop it,” Ex. 4 at 2, and an April 26, 2022 tweet stated, “Hold
your horses, y’all. Ivermectin may be trending, but it still isn’t authorized or
approved to treat COVID-19,” Ex. 7 at 2. Similarly, on August 21, 2021, FDA
posted on Instagram an image of a horse with the caption: “You are not a horse.
Stop it with the #Ivermectin. It’s not authorized for treating #COVID.” Ex. 6 at 2.
On April 10, 2020, FDA posted an FAQ on its website titled “FAQ: COVID-
19 and Ivermectin Intended for Animals.” Ex. 2. The FAQ was directed to
consumers. See id. at 2 (answering the question, “Should I take ivermectin to
prevent or treat COVID-19?”). The FAQ explained that “there are approved uses
for ivermectin in people and animals, but it is not approved for the prevention or
treatment of COVID-19.” Id. It added that “[a]ny use of ivermectin for the
prevention or treatment of COVID-19 should be avoided as its benefits and
safety for these purposes have not been established. Data from clinical trials are
necessary for us to determine whether ivermectin is safe and effective in treating
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or preventing COVID-19.” Id. The FAQ noted that although “[a] recently released
research article described the effect of ivermectin on SARS-CoV-2 in a laboratory
setting . . . [a]dditional testing [was] needed to determine whether ivermectin
might be appropriate to prevent or treat [COVID-19].” Id. (citations omitted).
Nonetheless, the FAQ recognized that doctors may choose to prescribe
ivermectin products approved for human use to prevent or treat COVID-19, and
it advised consumers “not [to] 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.” Id. (emphasis added). A similar consumer-directed FAQ
webpage also advised against taking ivermectin “for the prevention or treatment
of COVID-19,” explaining that it was not “approved or authorized” for those
uses, and included a link to the cited FDA article on that topic. Ex. 3 at 2.
In December 2021, FDA sent a letter to the Federation of State Medical
Boards and the National Association of Boards of Pharmacy based on FDA’s
receipt of “complaints about compounding pharmacies selling drug products
containing ivermectin, claiming that they can treat or prevent COVID-19.” Ex. 22 at
2 (emphasis added). The letter explained that although clinical trials were
“ongoing,” the “currently available data [did] not show” that the drug is “safe or
effective” for that use. Id. The letter concluded that using ivermectin to prevent
or treat COVID-19 “may pose risks to patient health” and that products claiming
to be safe and effective for that purpose when they have not been shown to be
“can place consumers at risk of serious harm.” Id.
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C. The Plaintiffs
1. Apter
Dr. Apter, who is licensed to practice in Arizona and Washington and sees
patients through myfreedoctor.com, “ha[s] frequently prescribed ivermectin” to
his patients to prevent or treat COVID-19. Ex. 8 ¶¶ 2, 6; see Am. Compl. ¶ 13.
Apter alleges that he has been “referred” to the Arizona Medical Board and the
Washington Medical Commission “for disciplinary proceedings for prescribing
ivermectin to treat COVID-19.” Ex. 8 ¶ 18; see Am. Compl. ¶ 18.

In September 2021, a pharmacist filed a complaint with the Washington
Medical Commission after a follow-up about one of Apter’s ivermectin
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prescriptions. When the pharmacist asked Apter about his patient’s diagnosis,
Apter allegedly “responded ‘for scabies,’ without asking for/verifying the
patient information.” Ex. B at 4. When the pharmacist “asked him to verify the
diagnosis per his medical records, he claimed that he was unable to find this
patient in his medical record system.” Id. Apter “did not appear to have any
recollection of the patient and was unable to locate any documentation
supporting an appropriate diagnosis or valid doctor-patient relationship.” Id.
The Washington Medical Commission subsequently issued a Statement of
Charges that alleged that Apter “failed to meet the standard of care in his
treatment of” his patients in several respects, none of which related to FDA’s
“recommendations” in the Statements. Ex. C at 5. For example, the Commission
alleged that Apter prescribed medication based “solely on an online
questionnaire and online chat” without “establish[ing] a physician-patient
relationship,” “failed to provide or obtain adequate informed consent to
[patients] when prescribing an off-label medication or prior to conducting the
visits via telemedicine,” “failed to discuss with [patients] the use of vaccines or
other methods to prevent a COVID-19 infection,” “failed to adequately evaluate”
patients when they reported symptoms, and “misrepresented to pharmacy staff”
the purpose of his prescriptions. Id. at 6. The Statement of Charges also alleged,
for example, that Apter failed to meet the standard of care when he prescribed a
medication (not ivermectin) and issued mask and vaccine exemptions. Id. at 16,
19, 22–23.

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2. Bowden
Dr. Bowden is a Texas physician and the owner of BreatheMD, a medical
practice where she treats patients with COVID-19, including by prescribing
ivermectin. Ex. 9 ¶¶ 2, 8, 14. She had privileges at Houston Methodist Hospital
but alleges that those privileges were suspended, after which she “voluntarily
resigned on November 15, 2021. Id. ¶ 7.
The available evidence shows that, in April 2021, Houston Methodist
required all medical staff to be vaccinated against COVID-19. Ex. E. Bowden
attested to the hospital that she had received the COVID-19 vaccine or planned
to receive it no later than June 7, 2021, Ex. F, but ultimately “decide[d] not to get”
the COVID-19 vaccine. Ex. G at 42. In her words, Bowden “became an opponent
of” both “vaccine mandates” and “the vaccines themselves,” and she “began
sharing [her] opinions on Twitter, including [her] view that vaccine mandates are
‘wrong.’” Id. at 31.
On November 11, 2021, Houston Methodist asked Bowden to provide proof
of vaccination status within seven days, noting that her recent statements on
social media “raise[d] questions” about her “compliance with the vaccination
requirement.” Ex. H. The letter explained that failure to comply with the
immunization requirement could “result in automatic relinquishment of clinical
privileges.” Id. The letter also addressed Bowden’s social media activity and
reminded Bowden that she had agreed to meet the institution’s standards of
professional conduct, and that “public use of vulgar, offensive and abusive
language directed at others” contradicted those standards. Id.; see Ex. I
(November 7, 2021 tweet: “C*nt? B*tch?”).
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According to a complaint filed by the Texas Medical Board, the next day the
hospital sent Bowden another letter noting that she had behaved in an
“unprofessional and inappropriate” manner to a hospital Department Chair and
advising that the hospital’s medical executive committee “was beginning an
investigation and implementing a precautionary suspension of her privileges for
no longer than 30 days.” Ex. J at 7–8. The hospital’s CEO told the press that she
had been suspended for “inappropriate behavior,” including “using vulgar and
foul language while expressing her opinions.” Ex. R at 4.
Bowden resigned on November 15, 2021, explaining that she did so
voluntarily, Ex. 9 at 2, and saying in a resignation letter that she “decided to part
ways with Houston Methodist because of the accusation that [she] ha[d] been
spreading ‘dangerous misinformation.’” Ex. K. Bowden subsequently filed a
defamation suit against the hospital and its CEO alleging that they published
intentionally false statements about her, that their conduct was motivated by
“bias and prejudice,” and that her reputation had been “severely compromised”
as a “direct result” of the alleged defamation. Ex. L ¶¶ 11, 25(d), 26, 31.
On November 20, 2021, Bowden wrote a message to her patients about her
relationship with other medical institutions. Ex. G at 47. Another hospital had
denied her request for privileges, and a surgery center told her that she could not
continue operating at the facility unless she provided proof that she had been
vaccinated, which was “not going to work for” her. Id. She announced that she
was “shifting [her] practice focus to treating the unvaccinated.” Id.
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3. Marik
Dr. Marik was a professor at Eastern Virginia Medical School (EVMS) and
Director of the Intensive Care Unit at Sentara Norfolk General Hospital (Sentara).
Ex. 10 at 3. His medical license expired in June 2021. Id. at 10. He does not allege
that he ever prescribed a patient ivermectin to prevent or treat COVID-19 or that
his employers prohibited him from promoting ivermectin for that use.
Marik alleges that he developed a “protocol” for treating COVID-19 that
included ivermectin, id. at 3, and that EVMS directed him to remove the protocol
from its servers and refrain from discussing it publicly after FDA’s August 21,
2021 tweet. Am. Compl. ¶ 40. Notably, a paper Marik published about the
protocol in the Journal of Intensive Care Medicine was retracted in November
2021 after Sentara notified the journal that “[t]he data from Sentara . . . reported
in th[e] paper are inaccurate.” Ex. M.
On September 27, 2021 Sentara decided to add ivermectin and five other
drugs to the “do not endorse” section of its treatment guidelines for treatment of
COVID-19, meaning that those medications would not be “verified or
dispensed” for that use at the hospital. Ex. 12 at 3, 6. Marik alleges that Sentara’s
treatment guidelines harmed his ability to practice medicine. Am. Compl. ¶¶ 40–
42. He states that he was “forced to resign from his positions at EVMS and
Sentara . . . for promoting the use of ivermectin—as well as other safe, cheap, and
effective off-label FDA-approved drugs—to treat COVID-19 following the FDA’s
attempts to stop use of those drugs for that purpose.” Id. ¶ 42.
The available evidence shows that Sentara initially allowed ivermectin to be
used to treat COVID-19 at the hospital, and eight patients received the drug for
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that purpose. Ex. N4 at 129–30. Sentara’s decision to add ivermectin to the “do
not endorse” section of the guidelines was based “primarily” on “clinical trials.”
Id. at 133. The hospital noted that many “professional societies across the United
States, including the Infectious Disease Society of America,” called for medical
professionals to stop prescribing ivermectin to treat COVID-19. Id. at 135. For
example, the hospital knew that the American Medical Association (AMA), the
American Society of Health-System Pharmacists (ASHP), and the American
Pharmacists Association (APhA) called for an “immediate end” to that use in a
joint statement. Id. That statement expressed “alarm” over “reports that
outpatient prescribing for and dispensing of ivermectin ha[d] increased . . .
exponentially over the past few months.” Ex. 25 at 2. It further observed that
“[t]he National Institutes of Health, World Health Organization, and Merck (the
manufacturer of the drug) all state there is insufficient evidence to support the
use of ivermectin to treat COVID-19.” Id. at 3. It added that “[c]alls to poison
control centers due to ivermectin ingestion have increased five-fold from their
pre-pandemic baseline,” and that the drug had “potentially toxic effects,
including nausea, vomiting, and diarrhea.” Id. “For more information,” the
statement “encouraged” the reader to “consult” FDA’s article, “Why You Should
Not Use Ivermectin to Treat or Prevent COVID-19” and a CDC Health Alert. Id.
Even under Sentara’s guidelines, Marik was not prohibited from writing a
prescription for ivermectin to treat COVID-19 outside the hospital or informing

4 Citations to Exhibit N are to the page numbers of the transcript, not the
sheet of the condensed transcript or to the page numbers assigned by ECF.
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patients about the treatment and encouraging them to seek it elsewhere. Ex. N at
122, 138.
Ultimately, Marik “felt it was time to focus [his] attention and energy to
other interests” and “resigned,” which was “not an easy decision to make.”
Ex. O. He planned to “dedicate more time to multiple causes,” including serving
as “co-founder of the Front Line COVID-19 Critical Care Alliance (FLCCC).” Id.
Marik and the FLCCC continued to promote Marik’s “Hospital Treatment
Protocol for COVID-19,” which included ivermectin. Ex. P.
II. Procedural History
A. Plaintiffs’ Amended Complaint
Plaintiffs filed their Amended Complaint on August 8, 2022. Count One
alleges an ultra vires claim for “non-statutory review,” which requires Plaintiffs
to show that FDA “was acting without any authority whatever, or without any
colorable basis for the exercise of authority” when it made the Statements. Apter
v. Dep't of Health & Hum. Servs., 80 F.4th 579, 587–88 (5th Cir. 2023) (quotations
omitted); see Am Compl. ¶¶ 129–31. Count Five seeks a declaratory judgment on
the same ground. Am. Compl. at ¶¶ 157–59. The other counts have been
dismissed, as described below.
B. Prior Proceedings
In December 2022, this Court granted Defendants’ motion to dismiss the
Amended Complaint on sovereign-immunity grounds. Apter v. U.S. Dep’t of
Health & Hum. Servs., 644 F. Supp. 3d 361, 372 (S.D. Tex. 2022). Specifically, the
Court ruled that the Administrative Procedure Act’s (“APA”) waiver of
sovereign immunity did not apply because Plaintiffs did not challenge final
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agency action. Id. at 370. It further held that Plaintiffs could not proceed under
the ultra vires doctrine, as “distinct” from the APA, because FDA had not acted
outside of a statutory limitation on its power and had “at least a colorable basis
in authority” to make the Statements. Id. at 368–69.
On appeal, the Fifth Circuit agreed that the Statements are not final agency
action because they did not “plausibly determine[] ‘rights or obligations,’” nor
did they “plausibly constitute[] action ‘from which legal consequences will
flow.’” Apter, 80 F.4th at 594 (quoting Data Marketing P’ship, LP v. U.S. Dep’t of
Labor, 45 F.4th 846, 853 (5th Cir. 2022)). Thus, Plaintiffs are “bar[red]” from
proceeding solely under the APA. Id. at 587. However, the Fifth Circuit held that
Plaintiffs could “use the APA to assert their ultra vires claim[].” Id. at 595. On the
one hand, the court explained that “FDA cites plenty of statutory authority
allowing it to issue information,” and it noted Plaintiffs’ agreement that “FDA has
statutory authority to share data, facts, and knowledge.” Id. at 588–89. On the
other hand, the court concluded that “mak[ing] medical recommendations” might
exceed the agency’s statutory authority. Id. at 589.
The Court of Appeals remanded and expressed “no view” on whether
Plaintiffs have standing, entrusting the “initial determination” of that issue to
this Court’s “sound judgment.” Apter, 80 F.4th at 595. This Court then authorized
Defendants to file a renewed motion to dismiss. ECF No. 55.
LEGAL STANDARDS
A motion to dismiss under Federal Rule of Civil Procedure 12(b)(1)
challenges a court’s subject-matter jurisdiction. Subject-matter jurisdiction,
including standing, must “be established as a threshold matter.” Steel Co. v.
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Citizens for a Better Env’t, 523 U.S. 83, 94–95 (1998). The Court is “presume[d]” to
“lack jurisdiction” unless Plaintiffs meet their “burden of establishing it.”
DaimlerChrysler Corp. v. Cuno, 547 U.S. 332, 342 n.3 (2006) (quotations omitted).
Challenges to subject-matter jurisdiction must be resolved “prior to addressing
the merits.” Alabama-Coushatta Tribe of Tex. v. United States, 757 F.3d 484, 487 (5th
Cir. 2014).
“A motion to dismiss for lack of standing may be either ‘facial’ or ‘factual.’”
Superior MRI Servs., Inc. v. All. Healthcare Servs., Inc., 778 F.3d 502, 504 (5th Cir.
2015) (quoting Paterson v. Weinberger, 644 F.2d 521, 523 (5th Cir. 1981)). In a
“facial” motion, the allegations in a complaint “are presumed to be true.”
Paterson, 644 F.2d at 523. Under a “factual” challenge, the defendant “submits
affidavits, testimony, or other evidentiary materials.” Id. A plaintiff then “must
prove the existence of subject-matter jurisdiction by a preponderance of the
evidence” and is “obliged to submit facts through some evidentiary method to
sustain his burden of proof.” Id. (quotations omitted). In a factual challenge, “no
presumptive truthfulness attaches to the [plaintiff’s] jurisdictional allegations,
and the court is free to weigh the evidence and satisfy itself as to the existence of
its power to hear the case.” Evans v. Tubbe, 657 F.2d 661, 663 (5th Cir. 1981).
ARGUMENT
The Amended Complaint should be dismissed for lack of subject-matter
jurisdiction because Plaintiffs have failed to establish standing. To show Article
III standing, Plaintiffs “must clearly allege facts demonstrating each element” of
standing, Spokeo, Inc. v. Robins, 578 U.S. 330, 338 (2016) (cleaned up): (1) an injury
in fact that is “concrete, particularized, and actual or imminent”; (2) “fairly
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traceable to the challenged action”; and (3) likely “redressable by a favorable
ruling,” Clapper v. Amnesty Int’l USA, 568 U.S. 398, 409 (2013). Plaintiffs “must
demonstrate standing for each claim . . . and for each form of relief.” TransUnion
LLC v. Ramirez, 141 S. Ct. 2190, 2208 (2021). “To request prospective injunctive or
declaratory relief,” a litigant cannot rely on “allegations of past harm,” but “must
demonstrate continuing harm or a real and immediate threat of repeated injury
in the future.” James v. Hegar, 86 F.4th 1076, 1081 (5th Cir. 2023) (quotations
omitted). “The threat of future injury must be certainly impending; mere
allegations of possible future injury will not suffice.” Id. (quotations omitted).
Because the Fifth Circuit affirmed the dismissal of Plaintiffs’ APA claims and
narrowed this case to Plaintiffs’ ultra vires claim, Plaintiffs must now show a
cognizable injury that is fairly traceable to any recommendations in the
Statements and that would likely be redressed by the relief sought. See Clapper,
568 U.S. at 409; Am. Compl. ¶¶ 131, 158–59. Under either a facial or a factual
challenge, they cannot.
First, Plaintiffs cannot show standing based on alleged injuries caused by
independent third-party conduct, such as third parties’ referring Apter for
disciplinary proceedings or third-party hospitals’ “forcing” Bowden and Marik
to resign. Second, the Amended Complaint itself, as well as external evidence,
refutes Plaintiffs’ allegation that they were unable to prescribe ivermectin to
prevent or treat COVID-19. Third, Plaintiffs’ abstract allegation that FDA
interfered with their practice of medicine does not show a concrete,
particularized injury to Plaintiffs, and Plaintiffs have not shown that they can
assert alleged injuries to third parties such as their patients. Finally, none of
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Plaintiffs’ alleged injuries are likely to be redressed by the relief they seek.
I.
Alleged Injuries Caused By Independent Third Parties Do Not Support
Plaintiffs’ Standing
A. Plaintiffs’ Allegations Are Facially Deficient
Taken at face value, Plaintiffs’ allegations of injury caused by independent
third parties do not plausibly show standing. Specifically, Apter alleges that
unnamed third parties referred him to state medical boards for disciplinary
proceedings. Am. Compl. ¶ 18. Bowden alleges that she was derided by Houston
Methodist Hospital, “publicly ridiculed,” and forced to resign her privileges at
the hospital, id. ¶ 21, and that patients have delayed seeking treatment from her,
id. ¶ 29. Finally, Marik alleges that he was forced to resign his employment at
EVMS and its associated hospital, Sentara, id. ¶ 42.
As an initial matter, Apter’s allegations do not show a concrete injury: he
does not allege that he has been disciplined and merely “[h]aving to defend
oneself in a legal proceeding ordinarily does not give rise to a redressable
injury.” Simic v. City of Chi., 851 F.3d 734, 739–40 (7th Cir. 2017).

and does
not allege any deprivation of due process. Bowden’s allegations are facially
deficient because her decision to “voluntarily resign[]” from Houston Methodist
Hospital, Ex. 9 ¶ 7, was “a self-inflicted injury,” Ctr. for Biological Diversity v. EPA,
937 F.3d 533, 541 (5th Cir. 2019). Moreover, she does not allege that the hospital’s
actions were attributable to FDA’s Statements. See Am. Compl. ¶ 21.
More generally, all three Plaintiffs’ alleged injuries were caused by “the
decision[s] of . . . independent third part[ies].” Daves v. Dallas Cnty., 22 F.4th 522,
543 (5th Cir. 2022) (en banc) (quoting California v. Texas, 141 S. Ct. 2104, 2117
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(2021)). The third parties’ actions were undoubtedly “independent”: Plaintiffs
have not plausibly alleged that FDA’s Statements had any “determinative or
coercive effect” on the third parties, such as the hospitals where plaintiffs
worked, Bennett v. Spear, 520 U.S. 154, 169 (1997), and the Fifth Circuit held that
the Statements did not establish a “legal standard,” “plausibly determine[]
‘rights or obligations,’” or “plausibly constitute[] action ‘from which legal
consequences will flow.’” Apter, 80 F.4th at 594 (quoting Data Marketing P’ship, 45
F.4th at 853); see also Physicians for Integrity in Med. Rsch., Inc. v. Ostroff, 670
F. App’x 450, 451 (9th Cir. 2016) (“Patients who choose to stop seeing Dr. Desai
as a result of Dr. Desai’s comments regarding roflumilast, or who end up finding
him less reputable, are making an independent choice unrelated to the FDA’s
actions.”).
Standing is “substantially more difficult” for Plaintiffs to establish, since the
Statements “neither require nor forbid any action” on their part. Summers v. Earth
Island Inst., 555 U.S. 488, 493–94 (2009). In this context, Plaintiffs must offer more
than “speculation” about the third parties’ decisions. Daves, 22 F.4th at 543
(quoting Clapper, 568 U.S. at 414). Instead, they must show that the third parties’
actions were a “predictable” response to any recommendations in the
Statements. Id. (quoting California, 141 S. Ct. at 2117).
Even on the face of the Amended Complaint, Plaintiffs have not met that
burden. The Statements generally recommended to consumers (who can purchase
the ivermectin product for horses over-the-counter) that they should not take
ivermectin to prevent or treat COVID-19 and did not proclaim that doctors may
not (or even should not) prescribe human-use ivermectin to prevent or treat
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COVID-19. Moreover, the September 2021 article and the April 2020 FAQ
expressly recognized that doctors have discretion to prescribe ivermectin. For
example, the statements advised that “[i]f 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.” Ex. 1 at 3; see also Ex. 2 at 2.5 The article likewise
recommended that patients talk to their doctors to determine their best treatment
options. Ex. 1 at 2. Thus, assuming the third parties that allegedly injured
Plaintiffs read the FDA’s Statements, they would likely have concluded that FDA
expressed concern about the risks, but that doctors have discretion to prescribe
ivermectin for COVID-19. Moreover, it is implausible that the sophisticated
actors in the health-care field that allegedly injured plaintiffs, such as hospitals
and state medical boards, base their decisions on FDA’s recommendations to
consumers in the Statements. Thus, the independent, third-party decisions that
allegedly injured Plaintiffs were not a “predictable” response to any
recommendations in the Statements, Daves, 22 F.4th at 543 (quoting California, 141
S. Ct. at 2117), and only through impermissible “speculation” could their
decisions be attributed to those Statements, id. (quoting Clapper, 568 U.S. at 414).
B. The Available Evidence Confirms that Plaintiffs Lack Standing
Defendants also assert a factual challenge to Plaintiffs’ standing. In a factual
challenge, Plaintiffs’ jurisdictional allegations lose their presumption of

5 The cited tweets included links to the article. See Ex. 4; Ex. 7; Am. Compl.
¶¶ 92, 100. Although the March 2021 version of this article stated that patients
should use ivermectin if it was prescribed “for an FDA-approved use,” Ex. 19 at
3, that text was removed when the article was updated in September 2021, and
Plaintiffs do not allege that any of the third-party conduct that allegedly injured
them was caused by the earlier version of the article.
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truthfulness and can be tested against the evidence, and the available evidence
confirms that Plaintiffs lack standing.
Even assuming that being referred to state medical boards is a cognizable
injury in fact,

The complaint initiating the Washington
Medical Commission proceeding alleged that, during a pharmacist’s follow-up
call with Apter about one of his ivermectin prescriptions, Apter did not ask for
any identifying patient information before telling the pharmacist the medication
was prescribed “for scabies.” Ex. B at 4. Apter allegedly “claimed that he was
unable to find this patient in his medical record system,” and “did not appear to
have any recollection of the patient and was unable to locate any documentation
supporting an appropriate diagnosis or valid doctor-patient relationship.” Id.
As discussed above, Bowden’s decision to “voluntarily resign[]” from
Houston Methodist Hospital, Ex. 9 ¶ 7, was “a self-inflicted injury” that does not
support standing. Ctr. for Biological Diversity, 937 F.3d at 541; supra p. 18. The
available evidence confirms that her resignation is not fairly traceable to the
Statements. According to Bowden, she resigned because of the hospital’s
independent decision to accuse her of spreading “dangerous misinformation.”
Ex. K. But the Texas Medical Board alleged that the hospital suspended her
privileges after she allegedly was “unprofessional and inappropriate” to a
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hospital Department Chair, Ex. J at 6–7, and the hospital’s CEO stated that the
suspension was for, among other things, “using vulgar and foul language,” Ex. R
at 4. Bowden later explained that she resigned her privileges because she had
decided to “shift[]” her “practice focus to treating the unvaccinated.” Ex. G at 47.
Neither Bowden’s stated reason for resigning nor her suspension were based on
the Statements.
Finally, Marik claims he was “forced to resign” his employment because he
“promot[ed]” ivermectin and other FDA-approved drugs to treat COVID-19,
Am. Compl. ¶ 42, but his organization, the FLCCC, announced that he resigned
“to dedicate more time to multiple causes” because he “felt it was time to focus
[his] attention and energy” on “other interests,” such as his role in the FLCCC.
Ex. O. As with Bowden, Marik’s decision to resign was “a self-inflicted injury”
that does not support standing. Ctr. for Biological Diversity, 937 F.3d at 541. To the
extent Marik’s claimed injuries are allegedly related to his promotion of
ivermectin at all, they at most were based on the independent decision of Sentara
to update its “COVID-19 Comprehensive Treatment Guidelines” (v.26) — to not
endorse (i.e., “not verif[y] or dispense[]”) ivermectin for treatment of COVID-19
in its hospitals. Ex. 12 at 6. Sentara’s independence in that regard is obvious, as it
cited how the “[c]oncentrations” of ivermectin that would “inhibit” the virus
“would be difficult to achieve in humans” and would be “extremely toxic”—
something not found in FDA’s Statements—and noted the absence of
information from a randomized controlled trial that might support its use. Id.; see
also Ex. N at 133 (Sentara “primarily” looked at clinical trials when making its
decision). But, in any event, Sentara did not prohibit doctors from prescribing
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ivermectin to prevent or treat COVID-19 outside its hospitals or from
encouraging their patients to use ivermectin for that purpose. Id. at 122, 138.
Thus, the evidence does not support Marik’s allegation that he was “forced to
resign” his employment because he “promot[ed]” ivermectin, Am. Compl. ¶ 42,
let alone his claim that his alleged injury was fairly traceable to FDA’s
Statements.
II. Plaintiffs Continue to Prescribe and Promote Ivermectin to Prevent or
Treat COVID-19
Plaintiffs allege that they have been “unable to prescribe” ivermectin due to
FDA’s Statements, Am. Compl. ¶ 121, but this allegation “is contradicted by the
other facts alleged in the complaint” and is therefore “implausible on its face.”
Mora v. Univ. of Tex. Sw. Med. Ctr., 469 F. App’x 295, 299 (5th Cir. 2012). The
Amended Complaint alleges that Apter “has frequently prescribed ivermectin”
to his patients, Am. Compl. ¶ 13, and he does not claim that myfreedoctor.com,
through which he has seen over 6,000 patients related to COVID-19, has
prevented him from prescribing ivermectin, see Ex. 8 ¶ 6. The Amended
Complaint likewise alleges that Bowden, who owns her own clinic, BreatheMD,
“prescribes ivermectin to treat COVID-19.” Am. Compl. ¶¶ 22, 26; see also
https://perma.cc/AAU4-ZBC (BreatheMD blog entry); see generally Ex. Q.
As for Marik, he only alleges that his resignation was related to his
promotion of ivermectin to treat COVID-19 and does not allege that he was ever
unable to prescribe it to treat COVID-19. Am. Compl. ¶¶ 38–43. Like the other
Plaintiffs, Marik has continued to promote the use of ivermectin to treat COVID-
19 after resigning his employment. See, e.g., Ex. P. The fact Marik has not
prescribed ivermectin in recent years is readily explained: his Virginia medical
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license expired in June 2021, and he does not have active licenses in other states.
Ex. 10 at 10. His lack of a valid credential (not FDA’s Statements) is what
prevents him from prescribing ivermectin in the future.
III. Plaintiffs’ Assertions Regarding “Interference” With Their Practice of
Medicine Do Not Support Standing
Plaintiffs also allege that FDA’s Statements “interfered with [their] ability to
exercise professional judgment in practicing medicine.” Am. Compl. ¶¶ 14, 24,
42, 121. This vague and conclusory assertion does not adequately allege a
concrete injury. See Spokeo, 578 U.S. at 338; Clapper, 568 U.S. at 409.
Plaintiffs’ more specific allegations fare no better. Plaintiffs allege that FDA’s
Statements have caused their patients to be unable to fill prescriptions for
ivermectin, Am. Compl. ¶ 15; have caused patients to delay seeking treatment
from Bowden, id. ¶ 29; and that those circumstances have caused hospitalizations
and deaths, which causes the patients, patients’ families, and healthcare
providers to suffer distress, id. ¶ 43. But these alleged injuries to third parties do
not satisfy the requirement of “personal injury” to Plaintiffs. California, 141 S. Ct.
at 2113 (quotations omitted). Courts “have adhered to the rule that a party
generally must assert his own legal rights and interests, and cannot rest his claim
to relief on the legal rights or interests of third parties.” Kowalski v. Tesmer, 543
U.S. 125, 129 (2004) (quotations omitted); see Ass’n of Am. Physicians & Surgeons v.
FDA, 13 F.4th 531, 544 (6th Cir. 2021) (observing in dicta that plaintiff “has not
identified a harm to physicians merely because the drug may not be available to
patients”). Contrary to Plaintiffs’ allegation, no general rule of standing allows
physicians to “invoke the rights of their actual or potential patients.” Am.
Compl. ¶ 125.
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Courts recognize “certain, limited exceptions” to the rule against asserting
third parties’ interests. Powers v. Ohio, 499 U.S. 400, 410–11 (1991). But to avail
themselves of an exception, Plaintiffs must first establish the Court’s jurisdiction
through their own standing. Ward v. Santa Fe Indep. Sch. Dist., 393 F.3d 599, 606
(5th Cir. 2004). As discussed herein, Plaintiffs cannot meet those fundamental
prerequisites, so they cannot invoke the interests of third parties.
Regardless, Plaintiffs also cannot meet the “important criteria” for invoking
the interests of third parties: “some hindrance to the third party’s ability to
protect his or her own interests” and “a close relation to the third party.” Powers,
499 U.S. at 410–11 (citations omitted). Most glaringly, Plaintiffs have not shown
any “hindrance to the third part[ies’] ability to protect [their] own interests.” Id.;
see Kowalski, 543 U.S. at 128–30. For example, Plaintiffs have not shown why
patients whose pharmacists allegedly refused to fill their ivermectin
prescriptions cannot seek legal recourse themselves. See AIDS Healthcare Found.,
Inc. v. City of Baton Rouge/Par. of E. Baton Rouge, No. 17-cv-229, 2017 WL 2899689,
at *4 (M.D. La. July 7, 2017) (medical clinic “failed to demonstrate that it has
standing to rely on alleged injuries sustained by its patients” because “there is no
indication that [those patients] are unable or unwilling to bring claims on their
own behalves”). Moreover, as commenters on Bowden’s website confirmed,
patients are able to get their ivermectin prescriptions filled and do not have to
seek legal recourse. See https://perma.cc/AAU4-ZBC. Furthermore, Plaintiffs
have not shown the requisite “close relation to the third part[ies].” Powers, 499
U.S. at 410–11; see Kowalski, 543 U.S. at 128–30.
Finally, the Supreme Court has recognized that plaintiffs may have standing
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to assert the rights of third parties if “enforcement of the challenged restriction
against the litigant would result indirectly in the violation of third parties’
rights.” Kowalski, 543 U.S. at 130 (cleaned up). But here, FDA’s Statements
imposed no restrictions on anyone. As the Court of Appeals recognized, they did
not establish a “legal standard” and were not actions “by which rights or
obligations have been determined, or from which legal consequences will flow.”
Apter, 80 F.4th at 594–95 (quotation omitted).
IV. Plaintiffs’ Injuries Are Not Likely to Be Redressed by the Requested
Relief
Even if the Court granted Plaintiffs’ requested relief, that would not likely
redress their injuries. Spokeo, 578 U.S. at 338; see El Paso Cnty. v. Trump, 982 F.3d
332, 341 (5th Cir. 2020). Plaintiffs’ sole surviving claim seeks, inter alia, a
declaration that FDA did not have authority to make the recommendations in the
Statements and an injunction prohibiting FDA from issuing such
recommendations. Am. Compl. pp. 43–44. But these remedies would not
“redress [Plaintiffs’] particular injur[ies].” Gill v. Whitford, 138 S. Ct. 1916, 1934
(2018) (quoting DaimlerChrysler, 547 U.S. at 353).
Plaintiffs argue that, if the Statements are vacated, “[h]ealth professionals
and state regulatory boards” will “revert to [the] norm” of “support[ing] the off-
label prescription of approved drugs.” Am. Compl. ¶ 124. But the question is not
whether the third parties will “support[] the off-label prescription of approved
drugs” generally, but instead whether they will likely reverse their actions that
allegedly harmed Plaintiffs. It is purely speculative to assert that a ruling that the
“recommendations” in the Statements were ultra vires would likely cause the
independent third parties who allegedly took actions that injured Plaintiffs to
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reverse those actions. It is far more likely that the relevant third-party actions
would be “held in place by other forces,” namely those third parties’
independent scientific knowledge about the therapeutic risks and benefits of
using ivermectin to prevent or treat COVID-19, even if the Court granted the
requested relief. Renal Physicians Ass’n v. U.S. Dep’t of Health & Hum. Servs., 489
F.3d 1267, 1278 (D.C. Cir. 2007) (no redressability even if governmental action is
a “contributing factor in bringing about a specific harm”). For example, Sentara
has made clear that it will not change its position on using ivermectin to prevent
or treat COVID-19 “until further studies” show that it is “safe and effective.”
Ex. 12 at 5.
This third-party knowledge is based on scientific assessments from yet more
independent third parties. For example, Merck, the sponsor of Stromectol®
(ivermectin), issued a statement on February 4, 2021—more than a month before
FDA’s article was first published—that advised against using ivermectin to
prevent or treat COVID-19.6 Many entities, such as the World Health
Organization,7 have issued similar advisories. See, e.g., Ex. 12 at 6 (noting that
recommendations had been issued by “[s]everal organizations, including” the
AMA, the ASHP, the Centers for Disease Control and Prevention, FDA, and
Merck); Ex. 25 (joint statement of the AMA, APhA, and ASHP, citing statements
by CDC, FDA, the National Institutes of Health, the World Health Organization,
Merck, and the Infectious Diseases Society of America); Am. Compl. ¶¶ 102–08.
Plaintiffs provide no reason why these scientific organizations would retract

6 See https://perma.cc/CEK9-FPAR.
7 See https://perma.cc/4R9K-WCZN.
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their statements if the Court were to hold that the portions of the cited FDA
statements making recommendations to consumers exceeded FDA’s legal
authority (particularly while leaving intact the portions of FDA’s Statements
providing scientific and factual information).8 Thus, it is, at best, “speculative”
whether the requested relief would redress Plaintiffs’ alleged injuries. Simon v. E.
Ky. Welfare Rts. Org., 426 U.S. 26, 43 (1976); see Dep’t of Educ. v. Brown, 143 S. Ct.
2343, 2353 (2023) (injury is not “redressable when the prospect of redress turns
on” a party’s “wholly discretionary decision”); El Paso Cnty., 982 F.3d at 341–42.
For similar reasons, even if Plaintiffs could assert their patients’ interests,
Plaintiffs’ allegation that “patients will no longer be caught between” the
Statements and “Plaintiffs’ advice,” Am. Compl. ¶ 124, does not show
redressability. Even if FDA’s recommendations to consumers were vacated, the
factual information FDA provided would remain, as would the
recommendations and information provided by Merck and many medical and
public health organizations. Moreover, to the extent pharmacies are declining to
fill prescriptions for ivermectin to prevent or treat COVID-19, the requested relief
would not likely redress the patients’ alleged injuries because it would not
change pharmacists’ knowledge about the risks and benefits of that use.
Plaintiffs also argue that their “professional judgment would no longer be
subject to pressure from the FDA.” Am. Compl. ¶ 124. But Apter and Bowden
have continued to prescribe ivermectin to prevent or treat COVID-19 and Marik
has continued to promote ivermectin to treat COVID-19 despite this alleged

8 For example, the NIH has continued to “recommend[] against the use of
ivermectin for the treatment of COVID-19.” https://perma.cc/3H93-KDNB (Dec.
20, 2023).
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“pressure” from FDA’s Statements. See supra, pp. 23–24. Thus, removing any
“psychic” pressure they feel would not redress any actual injury. Steel Co., 523
U.S. at 107.
Plaintiffs’ redressability argument fails for an additional reason. They ask the
Court to declare that the Statements “have no legal effect and do not bind health
professionals or patients.” Am. Compl. at 44. But the Court of Appeals has
already expressly held that the Statements have no legal effect, as this Court held
and as FDA has maintained all along. Apter, 80 F.4th at 595. A declaration of
what is already true would have “no effect” on Plaintiffs and could “not redress”
their injuries. Sykes v. FEC, 335 F. Supp. 2d 84, 92 (D.D.C. 2004) (quotations
omitted); cf. Steel Co., 523 U.S. at 109 (absent “a continuing violation or the
likelihood of a future violation, injunctive relief will not redress [an] injury”).
Nothing about the Plaintiffs’ individual situations leads to a different
outcome.
even assuming having to defend against a
disciplinary proceeding is a cognizable injury,

See supra p. 21; Ctr. for
Biological Diversity, Inc. v. BP Am. Prod. Co., 704 F.3d 413, 425 (5th Cir. 2013).
As to Bowden, the requested relief would not undo her voluntary
PUBLIC VERSION
Case 3:22-cv-00184 Document 62 Filed on 01/19/24 in TXSD Page 35 of 39

resignation of her privileges at Houston Methodist, Ex. K, nullify her apparent
past noncompliance with Houston Methodist’s standards of professional conduct
or vaccination requirements, Exs. G at 42; H; I; R at 4, or alter the statements by
Houston Methodist that Bowden alleges derided her and caused her to be
ridiculed, Am. Compl. ¶ 21.
Plaintiffs cannot show the requested relief could remedy any alleged harm to
Marik’s “ability to practice medicine” because his medical licenses are all
expired, Ex. 10 at 10, and he has not alleged that he intends to renew them. Marik
also alleges that he was forced to resign for “promoting the use of ivermectin—as
well as other safe, cheap, and effective off-label FDA-approved drugs—to treat COVID-
19.”Am Compl. ¶ 42 (emphasis added). The requested relief would not affect
these other reasons for his allegedly “forced” resignation and thus would not
remedy his alleged injuries. The requested relief also would not affect Marik’s
stated reason for resigning: to “dedicate more time” to “causes” like the FLCCC.
Ex. O. Finally, the requested relief could not restore Marik’s ability to promote
the use of ivermectin to prevent or treat COVID-19 because Marik never lost that
ability, having continued to promote that use even after he resigned. Ex. P.
Finally, Plaintiffs cannot show redressability (let alone any other
requirement for standing) regarding the first version of FDA’s consumer update,
Ex. 19, because that version has not been online since September 2021, well
before this action was filed, see Grupo Dataflux v. Atlas Glob. Grp., L.P., 541 U.S.
567, 570–71 (2004).
CONCLUSION
For the foregoing reasons, the Amended Complaint should be dismissed.
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Case 3:22-cv-00184 Document 62 Filed on 01/19/24 in TXSD Page 36 of 39

December 22, 2023

Respectfully submitted,

/s/ Isaac C. Belfer

ISAAC C. BELFER
Attorney-In-Charge
D.C. Bar No. 1014909

OLIVER MCDONALD
Of Counsel
N.Y. Bar No. 5416789

Trial Attorneys

Consumer Protection Branch

Civil Division

U.S. Department of Justice

PO Box 386

Washington, DC 20044-0386

(202) 305-7134 (Belfer)

(202) 305-0168

(202) 514-8742 (fax)

Isaac.C.Belfer@usdoj.gov

Oliver.J.McDonald@usdoj.gov

Counsel for Defendants
PUBLIC VERSION
Case 3:22-cv-00184 Document 62 Filed on 01/19/24 in TXSD Page 37 of 39

CERTIFICATE OF CONFERENCE
On August 2, 2022, pursuant to Rule 6 of the Rules of Practice of the
Galveston Division of the U.S. District Court for the Southern District of Texas,
Defendants’ counsel sent Plaintiffs’ counsel a letter stating the bases for their
intended motion to dismiss and informing Plaintiffs of their right to amend their
Complaint within 14 days. On August 4, 2022, the parties met and conferred
regarding Defendants’ intended motion to dismiss. On August 8, 2022, Plaintiffs
filed their Amended Complaint. ECF No. 12.

December 22, 2023

/s/ Isaac C. Belfer

Isaac C. Belfer
PUBLIC VERSION
Case 3:22-cv-00184 Document 62 Filed on 01/19/24 in TXSD Page 38 of 39

CERTIFICATE OF SERVICE

I hereby certify that this document, filed through the CM/ECF system, will
be sent via electronic mail to the registered participants as identified on the
Notice of Electronic Filing.

January 19, 2024

/s/ Isaac C. Belfer

Isaac C. Belfer

PUBLIC VERSION
Case 3:22-cv-00184 Document 62 Filed on 01/19/24 in TXSD Page 39 of 39

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Defendants' Renewed Motion to Dismiss — Apter v. HHS (Jan. 19, 2024) (S.D. Tex.)

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