Defendants' Reply in Support of Renewed Motion to Dismiss — Apter v. HHS (Feb. 14, 2024)

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U.S. District Court for the Southern District of Texas, Galveston Division · No. 3:22-cv-00184 · Doc. 67 · 2024-02-14 · Docket on CourtListener

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UNITED STATES DISTRICT COURT 
FOR THE SOUTHERN DISTRICT OF TEXAS 
GALVESTON DIVISION 
 
 
ROBERT L. APTER, et al., 
 
 
 
 
 
Plaintiffs, 
 
 
v. 
 
U.S. DEPARTMENT OF HEALTH 
AND HUMAN SERVICES, et al., 
 
 
 
 
 
Defendants. 
 
 
Case No. 3:22-cv-184 
 
JUDGE JEFFREY V. BROWN 
Defendants’ Reply in Support of Their 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 
ARGUMENT ......................................................................................................................... 1 
I. 
Redressability Is Not Presumed, and Plaintiffs Cannot Show It .................... 2 
II. Plaintiffs’ Theories of Standing Are Meritless .................................................. 5 
A. 
Bowden and Marik voluntarily resigned ..................................................... 5 
B. 
  
 .............................................................................................. 6 
C. 
The Statements’ claimed impact on Apter’s and Bowden’s practice of 
medicine does not support standing ............................................................. 8 
1. 
Abstract injury to the “practice of medicine” is not cognizable............. 8 
2. 
Apter and Bowden cannot rely on claimed injuries to 
 their patients ............................................................................................... 10 
3. 
Plaintiffs cannot show traceability or redressability .............................. 10 
D. 
Bowden’s alleged reputational injury does not support standing ......... 12 
E. 
Bowden’s claimed economic harm does not support her standing ....... 13 
F. 
Allegedly increased exposure to malpractice liability does not  
grant Apter or Bowden standing ................................................................. 14 
CONCLUSION .................................................................................................................... 15 
 
 
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TABLE OF AUTHORITIES 
Cases 
Alliance for Hippocratic Medicine v. FDA, 
78 F.4th 210 (5th Cir. 2023) ......................................................................................... 13 
Apter v. Dep’t of Health & Hum. Servs., 
80 F.4th 579 (5th Cir. 2023) ..................................................................................... 8, 15 
Ass’n of Am. Physicians & Surgeons v. FDA, 
13 F.4th 531 (6th Cir. 2021) ......................................................................................... 11 
Carpenters Indus. Council v. Zinke, 
854 F.3d 1 (D.C. Cir. 2017) ............................................................................................ 2 
Clapper v. Amnesty Int’l, 
568 U.S. 398 (2013) ................................................................................................. 11, 14 
Ctr. for Biological Diversity v. EPA, 
937 F.3d 533 (5th Cir. 2019) .......................................................................................... 5 
Daves v. Dallas Cnty., 
22 F.4th 522 (5th Cir. 2022) ................................................................................. 6, 7, 11 
DJC for DAC v. Staten Island Univ. Hosp.-Northwell Health, 
157 N.Y.S.3d 667 (N.Y. Sup. Ct., Richmond Cnty. 2021) ....................................... 15 
E.T. v. Paxton, 
41 F.4th 709 (5th Cir. 2022) ................................................................................. 2, 3, 12 
Garcia v. Home Depot USA, Inc., 
1999 WL 362787 (N.D. Tex. June 2, 1999) .................................................................. 9 
Gulfport Energy Corp. v. FERC, 
41 F.4th 667 (5th Cir. 2022) ........................................................................................... 7 
Huss v. Gayden, 
571 F.3d 442 (5th Cir. 2009) .......................................................................................... 5 
James v. Hegar, 
86 F.4th 1076 (5th Cir. 2023) ....................................................................................... 15 
June Med. Servs. LLC v. Russo, 
140 S. Ct. 2103 (2020) ................................................................................................... 10 
Kiser v. Reitz, 
765 F.3d 601 (6th Cir. 2014) .......................................................................................... 6 
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Louisiana v. Biden, 
64 F.4th 674 (5th Cir. 2023) ......................................................................................... 14 
Lujan v. Defs. of Wildlife, 
504 U.S. 555 (1992) ......................................................................................................... 2 
Massey v. Helman, 
35 F. Supp. 2d 1110 (C.D. Ill. 1999) ........................................................................... 10 
Nat’l Fed’n of the Blind of Texas, Inc. v. Abbot, 
647 F.3d 202 (5th Cir. 2011) ........................................................................................ 10 
Regents of the Univ. of Cal. v. Aisen, 
2016 WL 1428072 (S.D. Cal. Apr. 12, 2016) ................................................................ 9 
Renal Physicians Ass’n v. U.S. Dep’t of Health & Hum. Servs., 
489 F.3d 1267 (D.C. Cir. 2007) ...................................................................................... 2 
Simic v. City of Chi., 
851 F.3d 734 (7th Cir. 2017) .......................................................................................... 7 
Superior MRI Servs., Inc. v. All. Healthcare Servs., Inc., 
778 F.3d 502 (5th Cir. 2015) .......................................................................................... 5 
TransUnion LLC v. Ramirez, 
594 U.S. 413 (2021) ......................................................................................................... 9 
Ward v. Santa Fe Indep. Sch. Dist., 
393 F.3d 599 (5th Cir. 2004) ........................................................................................ 10 
Statutes and Regulations 
21 U.S.C. § 396 ................................................................................................................... 9 
22 Tex. Admin. Code § 291.29 ....................................................................................... 13 
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INTRODUCTION 
Defendants’ renewed motion to dismiss explained why the Court lacks 
subject-matter jurisdiction over Plaintiffs’ ultra vires claim, which all parties agree 
is the sole surviving claim in this case. None of the Plaintiffs has standing to 
challenge FDA’s Statements as ultra vires. Although Plaintiffs’ Opposition 
advances six theories of injury, none of them withstand scrutiny. 
For starters, Plaintiffs still have not met their burden of demonstrating an 
injury in fact. Plaintiffs’ own statements reveal that Bowden and Marik resigned 
voluntarily, not under duress as the Opposition argues—and self-inflicted 
injuries do not suffice for standing. Similarly, if Bowden spends less than an hour 
each month talking to pharmacists about ivermectin prescriptions, that does not 
amount to a cognizable injury; it is ordinary medical practice. Likewise, 
Plaintiffs’ Opposition fails to salvage any injury based on alleged interference 
with the practice of medicine, a speculative increased exposure to malpractice 
liability, Bowden’s purported reputational harm, or Apter’s referral to state 
medical boards. These failures are fatal to standing. 
Plaintiffs likewise have not shown any claimed injury was the predictable 
result of the Statements and therefore fairly traceable to them. Moreover, they 
offer nothing but speculation about how the relief they seek—limited changes to 
the Statements—would likely remedy any of their asserted injuries. 
ARGUMENT 
Plaintiffs’ Opposition offers six theories of injury: The Statements allegedly 
(1) caused Bowden and Marik to resign under duress, (2) resulted in Apter being 
referred for disciplinary proceedings, (3) interfered with Apter’s and Bowden’s 
practice of medicine, (4) caused Bowden reputational harm, (5) caused Bowden 
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economic harm, and (6) increased Apter’s and Bowden’s exposure to medical 
malpractice liability. ECF No. 61 (Opp’n) at 13–21. Each theory is meritless. And 
Plaintiffs have “waived” any other “argument[] in favor of standing.” E.T. v. 
Paxton, 41 F.4th 709, 718 n.2 (5th Cir. 2022) (emphasis and quotation omitted). 
Thus, Plaintiffs have not met their burden, either through the allegations in the 
Amended Complaint or with a showing by a preponderance of the evidence, that 
they face an injury-in-fact that is fairly traceable to the Statements and likely 
redressable by the requested relief. See ECF No. 59 (R-MTD) at 16. 
I. 
Redressability Is Not Presumed, and Plaintiffs Cannot Show It 
Beginning at the end, Plaintiffs are wrong that “redressability is presumed” 
if they establish an injury fairly traceable to the Statements. Opp’n 28. To be sure, 
when governmental action directly causes a claimed injury, enjoining the 
governmental action in question will “usually” redress that injury. Carpenters 
Indus. Council v. Zinke, 854 F.3d 1, 6 n.1 (D.C. Cir. 2017). However, if “the new 
status quo is held in place by other forces”—such as when the challenged 
governmental action is only one of many causes of a claimed injury—the 
“undoing of the governmental action” in question “will not undo the harm[].” 
Renal Physicians Ass’n v. U.S. Dep’t of Health & Hum. Servs., 489 F.3d 1267, 1278 
(D.C. Cir. 2007). That is particularly the case where, as here, Plaintiffs’ claim to 
redressability rests on “‘the unfettered choices made by independent actors not 
before the court[] and whose exercise of broad and legitimate discretion the 
court[] cannot presume either to control or predict.’” E.T., 41 F.4th at 720 
(quoting Lujan v. Defs. of Wildlife, 504 U.S. 555, 562 (1992)). 
The narrow relief Plaintiffs seek on the ultra vires claim would not redress 
their claimed injuries. Specifically, they seek a declaration that FDA’s statements 
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that “direct[] or opin[e] on whether ivermectin should be used for certain off-
label purposes” are unlawful, and equitable relief preventing FDA from making 
such statements. ECF No. 12 (Am. Comp.) at 43–44. Importantly though, after the 
Fifth Circuit’s decision in this case, the only agency conduct remaining at issue is 
FDA’s recommendations about using ivermectin to prevent or treat COVID-19, not 
any of the information provided in the Statements. See R-MTD 26–30. 
So, if Plaintiffs were to prevail, the article titled “Why You Should Not Use 
Ivermectin to Treat or Prevent COVID-19” could be renamed “Ivermectin Is Not 
FDA Approved or Authorized to Treat or Prevent COVID-19” and retain, for 
example, content on the drug’s risks and how “[c]urrently available data do not 
show ivermectin is effective against COVID-19.” See Ex. 1. Plaintiffs’ requested 
relief would leave much of the Statements’ content untouched. 
Plaintiffs can only speculate that such limited revisions would “likely” 
change third parties’ scientific understanding about the use of ivermectin to 
prevent or treat COVID-19, or convince third parties to reverse the actions that 
allegedly harmed Plaintiffs. See R-MTD 27–28. Plaintiffs’ redressability argument 
is especially speculative because it relies on multiple layers of “independent 
actors” not before the Court with discretion that the Court could not “control or 
predict.” E.T., 41 F.4th at 720.  
For example, the joint statement of the American Medical Association 
(AMA), the American Pharmacists Association (APhA), and the American 
Society of Health-System Pharmacists (ASHP) was prompted by their “alarm[]” 
about the recent “exponential[]” increase in prescriptions. Ex. 25 at 2. It invokes 
the conclusion of multiple independent organizations—the National Institutes of 
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Health (NIH), the World Health Organization (WHO), and Merck (the drug’s 
sponsor)—that there is “insufficient evidence” to support using ivermectin to 
treat COVID-19, and notes that the Infectious Diseases Society of America (IDSA) 
recommended against using it outside of a clinical trial. Ex. 25 at 2–3. It then 
advises that using ivermectin to treat COVID-19 “has been demonstrated to be 
harmful to patients.” Id. at 3. The joint statement links to FDA’s article as 
“indicating that ivermectin is not authorized or approved” to prevent or treat 
COVID-19 and only refers the reader to the article “[f]or more information.” Id. 
Even if this Court were to conclude that FDA lacked legal authority to make 
recommendations about ivermectin to consumers, Plaintiffs rely on pure 
conjecture when they contend that modifying FDA’s Statements would cause 
organizations like the AMA, the APhA, the ASHP, the NIH, the WHO, the IDSA, 
and Merck to suddenly “change course,” Opp’n 29 (citing the joint statement), 
and revise their statements and guidelines. The requested relief is similarly 
unlikely to alter the assessment of the scientific evidence by sophisticated 
healthcare entities like hospitals, boards of medicine, or pharmacies, particularly 
since the relief would be based on an issue of statutory authority, not science. 
Plaintiffs also suggest that they can meet their burden to show redressability 
because FDA “intended” the Statements to “precipitat[e]” Plaintiffs’ claimed 
injuries. Opp’n 3, 28–29. Plaintiffs misidentify FDA’s intent in making the 
Statements. As is clear from the face of the Statements, FDA’s intent was to 
inform consumers, not injure Plaintiffs. See, e.g., Ex. 1. 
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In sum, Plaintiffs have failed to meet their burden of showing it is likely the 
requested relief would cause the third parties who allegedly injured them to 
change course in a manner that would likely redress Plaintiffs’ alleged injuries. 
II. Plaintiffs’ Theories of Standing Are Meritless 
A. Bowden and Marik voluntarily resigned 
Plaintiffs now assert, without elaboration, that their resignations were 
“under duress.” Opp’n 20. Bald assertions will not suffice; Plaintiffs are “obliged 
to submit facts through some evidentiary method to sustain [their] burden of 
proof.” Superior MRI Servs., Inc. v. All. Healthcare Servs., Inc., 778 F.3d 502, 504 (5th 
Cir. 2015) (quotation omitted). And here, the evidentiary record contains 
Bowden’s and Marik’s admissions that they voluntarily resigned. Exs. 9 ¶ 7 
(Bowden’s declaration stating that she “voluntarily resigned”), G at 47 (Bowden 
resigned to “shift[]” her “practice” to treat unvaccinated patients), O at 2 (Marik 
resigned to “focus [his] attention and energy” on “other interests”); see also 
R-MTD 10–14; Ex. R (CEO’s statement that “Dr. Bowden voluntarily resigned”). 
Such “self-inflicted injur[ies]” cannot support their standing. Ctr. for Biological 
Diversity v. EPA, 937 F.3d 533, 541 (5th Cir. 2019). 
Furthermore, Bowden’s and Marik’s resignations are not fairly traceable to 
the Statements’ recommendations. Plaintiffs’ contention that the “timing” of their 
decisions “highlights” the Statements’ role in those decisions, Opp’n 21, suffers 
from the “post hoc ergo propter hoc fallacy,” which wrongly “assumes causality 
from temporal sequence,” Huss v. Gayden, 571 F.3d 442, 459 (5th Cir. 2009). 
Indeed, the evidence disproves Plaintiffs’ “false inference.” Id. For example, 
Bowden resigned from Houston Methodist Hospital after she was suspended for, 
among other things, disrespectful and vulgar behavior. Ex. R at 4. And Plaintiffs 
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2014)). But neither the Amended Complaint nor Plaintiffs’ brief identify the 
conduct at issue, establish that it is protected, or allege that Apter was ever told 
to cease that conduct by a disciplinary board or anyone else. 
 
 
 
 
 
 Plaintiffs do not argue that these allegations concern 
protected conduct.  
Plaintiffs suggest that the time and expense expended in Apter’s defense 
constitutes an injury, Opp’n 20, but this argument is not supported by any 
allegation in the Amended Complaint or any exhibit. Regardless, Plaintiffs do 
not dispute Defendants’ point that “[h]aving to defend oneself in a legal 
proceeding ordinarily does not give rise to a redressable injury.” R-MTD 18 
(quoting Simic v. City of Chi., 851 F.3d 734, 739 (7th Cir. 2017)); see also Gulfport 
Energy Corp. v. FERC, 41 F.4th 667, 677 (5th Cir. 2022) (“time and resources” 
expended in a defense to an agency proceeding is not a cognizable injury). 
Plaintiffs also fail to establish traceability or redressability with respect to the 
referrals. Contrary to Plaintiffs’ assumption, Opp’n 20, the referrals’ mere 
mention of FDA does not show they were a “predictable” response to FDA’s 
Statements, none of which tell physicians not to prescribe ivermectin or 
pharmacists to refrain from filling prescriptions. Daves, 22 F.4th at 543. And 
while the Washington complaint notes that ivermectin prescriptions were 
receiving additional scrutiny at that pharmacy, Ex. B at 4, Apter was not referred 
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because he failed to provide a non-COVID medical reason for the prescription. 
Opp’n 20. In fact, Apter did provide a non-COVID medical reason for the 
prescription: scabies. Ex. B at 4. The concern was the apparent absence of any 
documentation of the prescription or of a valid doctor-patient relationship. Id. 
Those issues were plainly untraceable to FDA’s Statements. Plaintiffs cannot 
show redressability for the same reason: 
 
 
C. The Statements’ claimed impact on Apter’s and Bowden’s practice of 
medicine does not support standing 
Defendants’ motion explained that Plaintiffs’ “interference with the practice 
of medicine” theory is vague and conclusory, and at most is a misguided attempt 
to invoke the interests of Apter’s and Bowden’s patients.1 R-MTD 24–25. 
Plaintiffs’ attempts to resuscitate this theory of injury are unpersuasive.2 
1. Abstract injury to the “practice of medicine” is not cognizable 
Plaintiffs ground their theory of “injury to their practice of medicine” in a 
hodgepodge of sources: a state rule of evidence protecting certain confidential 
communications between doctors and patients, the notion that physicians 
determine the best course of action for their patient, and a federal statute 
regarding medical devices. Opp’n 13–14. But even if these authorities recognize 
 
1 Plaintiffs do not dispute that because Marik is no longer licensed, see Ex. 10 
at 10, he could not suffer an injury to his nonexistent practice of medicine. 
2 Plaintiffs mischaracterize the Fifth Circuit’s decision when claiming it 
“already concluded” that FDA “interfere[ed] with the practice of medicine.” 
Opp’n 15 (citing Apter v. Dep’t of Health & Hum. Servs., 80 F.4th 579, 588–89, 595 
(5th Cir. 2023)). Actually, the Fifth Circuit ruled only that Plaintiffs had 
“plausibly alleged” the Statements went beyond FDA’s “authority to inform, 
announce, and apprise.” Apter, 80 F.4th at 595. 
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the doctor-patient relationship in the abstract, the Supreme Court has rejected 
Plaintiffs’ notion that a claimed violation of a legal principle is always a 
cognizable injury.3 TransUnion LLC v. Ramirez, 594 U.S. 413, 425–26 (2021). 
Plaintiffs also argue that, since courts recognize recreational and aesthetic 
injuries, courts must also recognize “interference with a vocation” as an injury. 
Opp’n 13. But recreational and aesthetic injuries are personal to the plaintiff. Not 
so with Plaintiffs’ novel “practice of medicine” theory, which would allow them 
to satisfy Article III without any direct effect on themselves (Plaintiffs always 
could prescribe ivermectin) and with only derivative effects on third party 
patients (such as when non-party “[i]nsurance companies” refuse to pay a claim 
for an ivermectin prescription). Opp’n 14. Unsurprisingly, Plaintiffs cite no 
support for this breathtakingly expansive view of standing. 
Finally, Plaintiffs argue that they have identified a “common-law analogue 
for their asserted injury”: tortious interference with a doctor-patient relationship. 
Opp’n 16–17 (quoting TransUnion, 594 U.S. at 417). But the cases cited in 
Plaintiffs’ brief reveal, the “harm” recognized in that cause of action is 
“economic” (not an injury to the abstract relationship itself), Regents of the Univ. 
of Cal. v. Aisen, 2016 WL 1428072, at *7 (S.D. Cal. Apr. 12, 2016), and the tort 
requires proof that the defendant acted with “malice,” Garcia v. Home Depot USA, 
Inc., 1999 WL 362787, at *6 (N.D. Tex. June 2, 1999). It does not describe an injury 
that is analogous to Plaintiffs’ abstract “interference with the practice of 
medicine” theory.  
 
3 The statute Plaintiffs cite, 21 U.S.C. § 396, by its own terms has no 
application here. See ECF No. 42 at 3–5. 
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2. Apter and Bowden cannot rely on claimed injuries to their 
patients 
Plaintiffs try to rely on injuries to third party patients, Opp’n 15–16, but 
Plaintiffs indisputably must first establish their own standing. R-MTD 25 (citing 
Ward v. Santa Fe Indep. Sch. Dist., 393 F.3d 599, 606 (5th Cir. 2004)). The third-
party standing doctrine, after all, “does not eliminate the distinct and 
independent requirement of Article III that the dispute between the parties must 
amount to a case or controversy.” Nat’l Fed’n of the Blind of Texas, Inc. v. Abbot, 647 
F.3d 202, 210 (5th Cir. 2011). Plaintiffs themselves lack standing, so any argument 
about unknown patients’ injuries is irrelevant. What’s more, Plaintiffs do not 
dispute Defendants’ observation that patients “do not have to seek legal 
recourse” since they “are able to get their ivermectin prescriptions filled.” 
R-MTD 25; see https://perma.cc/AAU4-ZBCL.  
Plaintiffs claim a special exception to the rule against third-party standing 
for “providers to invoke the rights of their actual or potential patients.” Opp’n 16 
(quoting June Med. Servs. LLC v. Russo, 140 S. Ct. 2103, 2118 (2020)). But that 
principle was expressly limited to challenges by “abortion providers” to 
“abortion-related regulations.” 140 S. Ct. at 2118. Abortion is “a very special 
context,” and “third party standing should not be extended to all cases where a 
physician seeks to assert some constitutional violation that the patients could 
bring themselves.” Massey v. Helman, 35 F. Supp. 2d 1110, 1116 (C.D. Ill.), aff’d, 
196 F.3d 727 (7th Cir. 1999). 
3. Plaintiffs cannot show traceability or redressability 
Even if Plaintiffs’ “interference with practice of medicine” theory were 
cognizable, they fail to show their injury is fairly traceable to the Statements’ 
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recommendations or likely redressable by their requested relief. Plaintiffs can 
only tie the Statements to their practice of medicine only through an implausible 
chain of decisions by independent third parties, i.e., sophisticated entities like 
pharmacists, hospitals, and medical boards, which exercise their own 
independent scientific judgment. Those entities’ decisions and actions were not a 
“predictable” response to any recommendations to consumers in the Statements 
and, as discussed, Plaintiffs have not shown that it is likely that the requested 
relief would change the conduct of those sophisticated actors. Plaintiffs’ 
argument to the contrary is impermissible “speculation.” Daves, 22 F.4th at 543.  
Plaintiffs’ citation to a letter FDA sent to two professional organizations, the 
Federation of State Medical Boards and the National Association of Boards of 
Pharmacy, does not suggest otherwise. The letter embeds a link to the article 
regarding known side effects of ivermectin and does not say anything about 
whether physicians can prescribe ivermectin to prevent or treat COVID-19. 
Instead, the letter explains that “FDA has received complaints about 
compounding pharmacies selling drug products containing ivermectin, claiming 
that they can treat or prevent COVID-19.” Ex. 22. In any event, those 
organizations are not “sovereign regulatory bod[ies],” so Plaintiffs’ reliance on 
FDA’s letter to them “confirms the central problem with [their] standing theory: 
The theory rests on pure guesswork about the decisions of parties not before the 
[C]ourt.” Ass’n of Am. Physicians & Surgeons v. FDA, 13 F.4th 531, 546 (6th Cir. 
2021) (citing Clapper v. Amnesty Int’l, 568 U.S. 398, 413 (2013)). 
In short, any “practice of medicine” injury is not redressable because it is 
pure conjecture that the limited modifications Plaintiffs seek to the Statements—
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which were among many statements made in the scientific community—would 
change the independent third parties’ scientific understanding of the risks and 
benefits of using ivermectin to prevent or treat COVID-19 or convince the third 
parties to reverse the actions that allegedly harmed Plaintiffs. See supra pp. 2–5. 
D. Bowden’s alleged reputational injury does not support standing 
Bowden argues she “suffered reputational harm,” based on two social media 
posts by private citizens. Opp’n 18–19 (citing Exs. 23, 24). But the mere existence 
of a third party’s derogatory statement on the internet does not translate to a 
reputational injury sufficient for standing. Contra id. 19. Conspicuously, neither 
the Amended Complaint nor Bowden’s declarations even allege in more than 
bare conclusory fashion—let alone establish by a preponderance of the 
evidence—that these social media posts or anything else harmed her reputation. 
See Am. Comp. ¶ 105; Exs. 9, 29 (Bowden declarations).4 
Plaintiffs also fail to establish that any reputational injury from third-party 
social media posts is fairly traceable to the Statements (which do not mention 
Plaintiffs) or redressable. They argue only that the social media posts “have 
referenced” the Statements. Opp’n 24. That falls far short of establishing by a 
preponderance of the evidence that Bowden’s alleged reputational injury was the 
“predictable” effect of the Statements. Plaintiffs likewise do not explain how 
their requested relief would ameliorate Bowden’s supposed reputational injury 
caused by the social media posts. For example, Plaintiffs do not suggest that the 
users “@LoveLogCabins” (whose account appears to have been deleted) or 
 
4 Plaintiffs assert that they “have suffered reputational harm” but only cite 
exhibits regarding Bowden. Plaintiffs have thus waived any standing argument 
based on reputational harm to Apter or Marik. E.T., 41 F.4th at 718 n.2. 
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“@rx0rcist” would alter the content of their posts in response to the limited 
modifications to the Statements that Plaintiffs request. And Bowden has placed 
the blame for alleged harm to her reputation squarely on the shoulders of 
Houston Methodist Hospital and its CEO. Bowden alleged that the hospital held 
“extreme and unrelenting bias” and “spite” towards her practice and “severely 
compromised” her reputation via “intentionally false statements” spread “in the 
broadest manner possible.” Ex. L ¶¶ 11, 25(d)&(e). 
E. Bowden’s claimed economic harm does not support her standing 
Bowden also claims that the Statements caused her economic harm. Opp’n 
17–18. Yet her unsworn “Supplemental Declaration” states only that, with 
decreasing frequency, she speaks to pharmacists a few times a month for about 
15 minutes regarding her ivermectin prescriptions, which she says takes time 
away from her other responsibilities. Ex. 29. Notably, Bowden does not state 
these calls cause her economic harm, much less provide facts about the financial 
impact. See id. Plaintiffs simply offer no evidence of any concrete financial injury.  
Bowden’s alleged injury is unlike the one addressed in Alliance for Hippocratic 
Medicine v. FDA. Contra Opp’n 17–18. In Alliance, the plaintiff doctors claimed 
they would be required, over their conscience objections, to devote significant 
time to “provid[e] emergency treatment” to patients who had been prescribed an 
allegedly unsafe drug by other doctors. 78 F.4th 210, 229, 232–33 (5th Cir. 2023), 
cert granted, Nos. 22-235, 22-236 (U.S.). Here, by contrast, Bowden chooses to 
prescribe ivermectin with full awareness that, as with any prescription, some 
pharmacists may have questions and contact her to discuss. See 22 Tex. Admin. 
Code § 291.29 (Professional Responsibility of Pharmacists); see also 
https://perma.cc/8KCG-YS59 (September 2021 joint statement of the Texas 
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Case 3:22-cv-00184   Document 67   Filed on 02/14/24 in TXSD   Page 18 of 22

 
14 
Medical Board and Texas State Board of Pharmacy stating that drugs were 
“permitted to be prescribed off-label” and that it was in the “professional 
judgment” of physicians to write prescriptions and of pharmacists to dispense 
them). Aside from marshalling no evidentiary support, Plaintiffs have cited no 
authority that Bowden’s calls with pharmacists are a justiciable injury rather than 
one of the basic responsibilities of being a physician. 
Bowden’s economic injury theory also has the same traceability and 
redressability defects as Plaintiffs’ other theories. The recommendations to 
consumers in FDA’s Statements would not predictably impact pharmacists’ 
exercise of their individual professional discretion, and it is pure speculation that 
the limited modifications to the Statements Plaintiffs seek would impact the 
views of any pharmacists who are resistant to filling Bowden’s prescriptions. 
F. Allegedly increased exposure to malpractice liability does not grant 
Apter or Bowden standing  
Plaintiffs allege that the Statements “expose[]” them to “increased liability 
for their continued prescribing of ivermectin” because one court cited one of 
FDA’s Statements when “determin[ing]” an element of medical malpractice. 
Opp’n 18. But this theory of injury rests on a “highly attenuated chain of 
possibilities” insufficient to demonstrate an injury-in-fact. Louisiana v. Biden, 64 
F.4th 674, 682 (5th Cir. 2023) (quoting Clapper, 568 U.S. at 410). Apter and 
Bowden5 tout their successful treatment of thousands of patients with 
ivermectin, Exs. 8 ¶ 6, 9 ¶ 5, but do not claim to have faced a single malpractice 
allegation. It is entirely speculative that Apter or Bowden will face an ivermectin-
 
5 Because Marik is not a licensed physician, see Ex. 10 at 10, he does not have 
malpractice liability exposure that could be increased. 
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15 
related malpractice allegation in the future and, even if they did, they offer no 
evidence that any court would find prescribing ivermectin to be malpractice. 
Indeed, Plaintiffs do not cite a single case where a physician has ever been found 
liable for malpractice based on off-label use of ivermectin. See Opp’n 9 (collecting 
cases concerning whether hospitals could be compelled to administer ivermectin 
to patients with COVID-19). Plaintiffs’ “increased exposure to malpractice 
liability” theory is simply too speculative to constitute a cognizable injury, let 
alone establish the other elements of standing.6 
CONCLUSION 
The Amended Complaint should be dismissed for lack of subject matter 
jurisdiction. 
 
 
 
6 Plaintiffs’ only source purporting to connect malpractice liability to the 
Statements is a trial court decision declining to order a hospital to administer 
ivermectin to a patient, not a medical malpractice case. Opp’n 18 (citing DJC for 
DAC v. Staten Island Univ. Hosp.-Northwell Health, 157 N.Y.S.3d 667, 673 (N.Y. 
Sup. Ct., Richmond Cnty. 2021)). There, the court found “persuasive” physicians’ 
affidavits that ivermectin should not be administered to a patient, since the 
patient was “not suffering from an active COVID-19 infection” but instead from 
bacterial pneumonia, which is not treated with ivermectin. DJC for DAC, 157 
N.Y.S.3d at 673. And that court cited FDA’s article for the proposition that “there 
is no current evidence to justify off-label use of Ivermectin at this time,” id., a 
proposition not at issue in this case. See Am. Comp. ¶ 3 (“This case is not about 
whether ivermectin is an effective treatment for COVID-19.”); Apter, 80 F.4th at 
588–89 (noting that Plaintiffs’ ultra vires claim does not concern FDA’s authority 
to “issue information” but its authority to make “recommendations”). That case 
does not show that Apter and Bowden face a “certainly impending” injury, James 
v. Hegar, 86 F.4th 1076, 1081 (5th Cir. 2023), let alone an injury traceable to the 
recommendations in the Statements or redressable by limited alterations to those 
Statements. 
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16 
January 19, 2024 
 
 
 
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
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Case 3:22-cv-00184   Document 67   Filed on 02/14/24 in TXSD   Page 21 of 22

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. 
February 14, 2024 
/s/ Isaac C. Belfer 
Isaac C. Belfer 
PUBLIC VERSION
Case 3:22-cv-00184   Document 67   Filed on 02/14/24 in TXSD   Page 22 of 22

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