Court filing

Defendants' Reply in Support of Motion to Dismiss — Apter v. HHS (Oct. 21, 2022)

Filed October 21, 2022 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	2022-10-21

U.S. District Court for the Southern District of Texas, Galveston Division · No. 3:22-cv-00184 · Doc. 42 · 2022-10-21 · 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’ Reply in Support of Their Motion to Dismiss the
Amended Complaint
OF COUNSEL:

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

MARK RAZA
Associate General Counsel
Food and Drug Division
U.S. Department of Health
and Human Services
Chief Counsel
Food and Drug Administration

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

LEAH A. EDELMAN
BRIAN M. BOYNTON
Principal Deputy Assistant Attorney
General

ARUN G. RAO
Deputy Assistant Attorney General

GUSTAV W. EYLER
Director

HILARY K. PERKINS
Assistant Director

ISAAC C. BELFER
Attorney-In-Charge
D.C. Bar No. 1014909
OLIVER MCDONALD
Of Counsel
N.Y. Bar No. 5416789
Trial Attorneys
Case 3:22-cv-00184 Document 42 Filed on 10/21/22 in TXSD Page 1 of 30

Associate Chief Counsel
Food and Drug Administration
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 ......................................................................................................................... 2
I.
Plaintiffs Have Not Shown that the Court Has Subject Matter
Jurisdiction ........................................................................................................ 2
A.
Plaintiffs Have Not Met Their Burden to Show Standing ......................... 2
1.
Plaintiffs Have Failed to Show an Adequate Injury in Fact for Many of
Their Alleged Injuries ...................................................................................... 2
2.
Plaintiffs Have Failed to Show that Their Alleged Injuries Are Fairly
Traceable to the Cited FDA Statements ........................................................ 8
3.
Plaintiffs Have Failed to Show that Their Alleged Injuries Are Likely
Redressable by the Requested Relief ........................................................... 12
B.
Plaintiffs Have Not Met Their Burden to Show a Waiver of Sovereign
Immunity ......................................................................................................... 16
II.
Plaintiffs Forfeited Their Arguments by Declining to Raise Them With
FDA Prior to Filing this Lawsuit ................................................................. 21
CONCLUSION .................................................................................................................... 22

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TABLE OF AUTHORITIES
Cases
Action on Smoking & Health v. Harris,
655 F.2d 236 (D.C. Cir. 1980) ...................................................................................... 22
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) ........................................ 6
Alabama-Coushatta Tribe of Tex. v. United States,
757 F.3d 484 (5th Cir. 2014) ........................................................................................ 18
Ark. v. Wilmington Tr. Nat’l Ass’n,
2020 WL 1249570 (N.D. Tex. Mar. 16, 2020) ........................................................ 8, 12
Ass’n of Am. Physicians & Surgeons v. FDA,
13 F.4th 531 (6th Cir. 2021) ........................................................................................... 7
Avoyelles Sportsmen’s League, Inc. v. Marsh,
715 F.2d 897 (5th Cir. 1983) ........................................................................................ 17
Bennett v. Spear,
520 U.S. 154 (1997) ................................................................................................. 18, 19
Buckman Co. v. Plaintiffs’ Legal Comm.,
531 U.S. 341 (2001) ......................................................................................................... 4
Clapper v. Amnesty Int’l USA,
568 U.S. 398 (2013) ......................................................................................................... 3
Community for Creative Non-Violence v. Pierce (“CCNV”),
814 F.2d 663 (D.C. Cir. 1987) ...................................................................................... 16
Danos v. Jones,
652 F.3d 577 (5th Cir. 2011) ........................................................................................ 17
Data Marketing Partnership, LP v. U.S. Department of Labor,
45 F.4th 846 (5th Cir. 2022) ................................................................................... 18, 19
Daves v. Dallas County,
22 F.4th 522 (5th Cir. 2022) ........................................................................................... 9
DeMarco v. Christiana Care Health Servs., Inc.,
263 A.3d 423 (Del. Ch. 2021) ...................................................................................... 11
Frey ex rel. Frey v. Health-Michigan,
No. 359446, 2021 WL 5871744 (Mich. Ct. App. Dec. 10, 2021) .............................. 11

Case 3:22-cv-00184 Document 42 Filed on 10/21/22 in TXSD Page 4 of 30

iii

Griffith v. FLRA,
842 F.2d 487 (D.C. Cir. 1988) ................................................................................ 16, 17
Henley v. FDA,
77 F.3d 616 (2d Cir. 1996) ........................................................................................... 22
June Med. Servs. LLC v. Russo,
140 S. Ct. 2103 (2020) .................................................................................................... 6
Kiser v. Reitz,
765 F.3d 601 (6th Cir. 2014) ......................................................................................... 7
Koretoff v. Vilsack,
707 F.3d 394 (D.C. Cir. 2013) ...................................................................................... 22
Larson v. Domestic & Foreign Com. Corp.,
337 U.S. 682 (1949) ....................................................................................................... 16
Massey v. Helman,
35 F. Supp. 2d 1110 (C.D. Ill.), aff’d,
196 F.3d 727 (7th Cir. 1999) .......................................................................................... 7
McKart v. United States,
395 U.S. 185 (1969) ....................................................................................................... 21
Meese v. Keene,
481 U.S. 465 (1987) ....................................................................................................... 15
Palm Valley Health Care v. Azar,
947 F.3d 321 (5th Cir. 2020) ........................................................................................ 21
Pennhurst State Sch. & Hosp. v. Halderman,
465 U.S. 89 (1984) ......................................................................................................... 17
Renal Physicians Ass’n v. U.S. Dep’t of Health & Hum. Servs.,
489 F.3d 1267 (D.C. Cir. 2007).................................................................................... 12
State v. Biden,
10 F.4th 538 (5th Cir. 2021) ......................................................................................... 20
Summers v. Earth Island Inst.,
555 U.S. 488 (2009) ......................................................................................................... 8
Tampa Times Co. v. NLRB,
193 F.2d 582 (5th Cir. 1952) .......................................................................................... 9
Texas v. EEOC,
933 F.3d 433 (5th Cir. 2019) ........................................................................................ 19

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Tozzi v. U.S. Department of Health and Human Services,
271 F.3d 301 (D.C. Cir. 2001) ................................................................................ 14, 15
TransUnion LLC v. Ramirez,
141 S. Ct. 2190 (2021) .................................................................................................... 3
U.S. Army Corps of Eng’rs v. Hawkes Co.,
578 U.S. 590 (2016) ....................................................................................................... 20
U.S. ex rel. King v. Solvay Pharmaceuticals,
871 F.3d 318 (5th Cir. 2017) .......................................................................................... 4
United States v. Mitchell,
463 U.S. 206 (1983) ....................................................................................................... 16
Va. House of Delegates v. Bethune-Hill,
139 S. Ct. 1945 (2019) .............................................................................................. 8, 12
Walmart Inc. v. U.S. Dep’t of Just.,
21 F.4th 300 (5th Cir. 2021) ......................................................................................... 17
Statutes
5 U.S.C. §
551(4) ............................................................................................................................. 17
702 ................................................................................................................................. 18
704 ................................................................................................................................. 22
21 U.S.C. § 396 ......................................................................................................... 3, 4, 17
Regulations
21 C.F.R. §
10.25(a) .......................................................................................................................... 22
10.25(b) .......................................................................................................................... 21
312.2(d) ........................................................................................................................... 5
Other Authorities
52 Fed. Reg. 8798 (Mar. 19, 1987) .................................................................................... 5

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INTRODUCTION
After receiving multiple reports of patients who required medical attention,
including hospitalization, after self-medicating with ivermectin products
intended for livestock,1 FDA warned the public about certain risks related to
using products containing ivermectin to prevent or treat COVID-19. Plaintiffs are
doctors who prescribe ivermectin or promoted its use to prevent or treat COVID-
19. In this suit, they seek to prevent FDA from communicating to the public its
concerns about the potential risks of using ivermectin for that purpose. They
allege that the statements cited in the Amended Complaint2 caused them injuries,
including interference with their “practice of medicine,” being forced to resign
from their jobs, and referrals for disciplinary proceedings.
Defendants’ motion to dismiss showed that the Court does not have
jurisdiction and that Plaintiffs failed to state a plausible claim for relief. Plaintiffs’
Opposition fails to remedy these fatal defects.
Plaintiffs have not met their burden to show standing. Many of their alleged
injuries are not adequate injuries in fact. For example, Plaintiffs argue that the
cited statements interfered with the “practice of medicine,” but Plaintiffs have
not alleged that they have been unable to prescribe ivermectin to prevent or treat
COVID-19. Plaintiffs also cannot rely on their patients’ alleged injuries because

1 Contrary to Plaintiffs’ assertion, Opp’n 9–10, the March 2021 version of the
cited article stated that the U.S. Food and Drug Administration (“FDA”)
“received multiple reports of patients who have required medical support and
been hospitalized after self-medicating with ivermectin intended for horses,” Ex.
19 at 2.
2 The Amended Complaint identifies two versions of an article and two
FAQs posted on FDA’s website, two tweets linking to the article, an Instagram
post, and a letter to two organizations (hereafter, the “cited statements”).
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they have not shown that their patients are unable or unwilling to seek relief
themselves. None of the claimed injuries are traceable to the cited statements
because they were caused by independent third-party conduct that was not a
predictable response to those statements. Furthermore, the requested relief
would not likely redress Plaintiffs’ claimed injuries because, among other things,
it would not likely cause the third parties to reverse their past decisions.
The Court also lacks jurisdiction because Plaintiffs have failed to show a
waiver of sovereign immunity. In Count One, Plaintiffs invoke the narrow “ultra
vires” doctrine, but they have not met their burden to show that FDA acted
without any authority. The waiver of sovereign immunity in the Administrative
Procedure Act (“APA”) does not apply either because, among other reasons, the
cited statements were not final agency action.
Finally, Plaintiffs have failed to state a claim because they did not present
their issues to FDA before filing suit. Issue exhaustion ensures fairness to the
agency and the efficient resolution of parties’ claims, and Plaintiffs have not
shown why their failure to exhaust their issues should be excused here.
ARGUMENT
I. Plaintiffs Have Not Shown that the Court Has Subject Matter
Jurisdiction
A. Plaintiffs Have Not Met Their Burden to Show Standing
1. Plaintiffs Have Failed to Show an Adequate Injury in Fact for
Many of Their Alleged Injuries
Plaintiffs’ Opposition fails to show that, for many of their alleged injuries,3

3 Although certain of Plaintiffs’ alleged injuries, such as being forced to
resign from their jobs, might be an adequate injury in fact, such injuries do not
ultimately support standing because Plaintiffs have not shown that they are

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Plaintiffs suffered an injury that is “concrete, particularized, and actual or
imminent.” Clapper v. Amnesty Int’l USA, 568 U.S. 398, 409 (2013) Dkt. 25 (“Mot.”)
12–15. By itself, Plaintiffs’ “vague and conclusory” allegation that FDA
“interfere[d] with the practice of medicine,” Dkt. 12 (“Am. Compl.”) ¶ 10, does
not show “a concrete injury to Plaintiffs,” Mot. 12. The allegation does not, for
example, identify any particular action that Plaintiffs were prevented from
taking, but instead alleges interference with an abstract concept.4
In a flawed attempt to show an injury in fact, Plaintiffs argue that 21 U.S.C.
§ 396 provides “a statutorily protected interest against FDA interference with
their practice of medicine,” which they define to include any “hindrance in the
doctor-patient relationship, including actions that would ‘deter off-label use.’”
Opp’n 13–14. This argument fails for multiple reasons.
First, an alleged statutory violation does not necessarily show a concrete
injury. See TransUnion LLC v. Ramirez, 141 S. Ct. 2190, 2205 (2021). Courts still
must “independently decide whether a plaintiff has suffered a concrete harm
under Article III.” Id. Thus, even if Plaintiffs could show a violation of section
396, their vague and conclusory allegations concerning interference with the
practice of medicine would still fail to show a concrete injury. See Clapper, 568
U.S. at 409; Mot. 12.
Second, section 396, by its plain language, concerns devices, not drugs like
ivermectin. 21 U.S.C. § 396; Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341,

traceable to the cited statements or redressable by the requested relief. See infra
pp. 8–16.
4 Plaintiffs’ allegations of more particular injuries, such as some pharmacists
refusing to fill their patients’ ivermectin prescriptions, are also inadequate for the
reasons discussed below.
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350 (2001) (noting that section 396 concerns “the marketing and distribution of
medical devices” (emphasis added)). Plaintiffs are wrong to assert that the Fifth
Circuit has interpreted section 396 “as applying to” drugs as well. Opp’n 3.
Plaintiffs cite U.S. ex rel. King v. Solvay Pharmaceuticals, a False Claims Act case
involving allegations of off-label marketing. 871 F.3d 318, 327–28 (5th Cir. 2017).
The court noted that “FDA does not restrict physicians from prescribing an
otherwise FDA-approved drug for an off-label use,” and it supported that
undisputed proposition with a “see” citation to section 396 and a parenthetical
that quoted the statute’s language regarding “device[s].” Id. at 328. In other
words, the court cited the statute to provide indirect support for its statement
about drugs while expressly recognizing that the statute applies to devices. The
other cases Plaintiffs cite are unpersuasive for the same reason. See Opp’n 4 n.2.
Similarly, the legislative history Plaintiffs cite fails to overcome the statute’s plain
language. See id. at 4 (quoting H.R. Rep. 105-399).
Third, even if section 396 applied to drugs, it would not support Plaintiffs’
claimed statutory violation. It does not create any general “interest against FDA
interference with the[] practice of medicine.” Opp’n 13–14. Section 396 provides
that “[n]othing in” the FDCA “shall be construed to limit or interfere with the
authority of a health care practitioner to prescribe or administer any legally
marketed device to a patient for any condition or disease within a legitimate
health care practitioner-patient relationship.” 21 U.S.C. § 396 (emphasis added).
The information and recommendations in the cited statements did not “limit or
interfere with the authority” of doctors to prescribe products containing
ivermectin to prevent or treat COVID-19. 21 U.S.C. § 396. Plaintiffs do not allege
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that the cited statements impaired their authority to prescribe ivermectin for that
use. Indeed, the September 2021 version of the article and the April 2020 FAQ
acknowledged that doctors have discretion to prescribe ivermectin products. Ex.
1 at 3;5 Ex. 2 at 2; see also Ex. 27 at 23 (FDA Letter to Stakeholders).
FDA’s longstanding position is that, in general, the agency does not regulate
the practice of medicine, meaning that, with few exceptions, health care
professionals generally may choose to prescribe or use a legally marketed human
drug for an unapproved use when they judge that the unapproved use is
medically appropriate for an individual patient. See Mot. 3 n.2. This position
predates the 1997 enactment of section 396. See, e.g., 52 Fed. Reg. 8798, 8803 (Mar.
19, 1987). But FDA’s position regarding the “practice of medicine” has never
cabined its ability to communicate with the public regarding the products it
regulates. Indeed, the agency routinely communicates with the public, including
warning of risks associated with an unapproved use of an approved drug. See
Mot. 4.6
Plaintiffs argue that the cited statements interfered “many times” with their
“ability to prescribe and administer ivermectin” to prevent or treat COVID-19,
Opp’n 13–14, but the Amended Complaint does not allege any such instance. To

5 Citations to exhibits refer to the exhibits to the Amended Complaint. Cited
page numbers refer to the page numbers assigned by PACER.
6 Amicus America’s Frontline Doctors (“AFLDS”) ignores the text of 21
C.F.R. § 312.2(d) in arguing that FDA’s cited statements violated that regulation.
AFLDS at 1, 3. FDA’s regulations in 21 C.F.R. Part 312 govern clinical
investigations of drugs for human use. Consistent with FDA’s view of the
practice of medicine, section 312.2(d) states that those regulations do “not apply
to the use in the practice of medicine for an unlabeled indication of a new drug
product approved under part 314 or of a licensed biological product.” That
regulation has no bearing on FDA’s authority to communicate with the public.
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the contrary, it confirms that Plaintiffs have continued to prescribe ivermectin for
that purpose. See, e.g., Am. Compl. ¶¶ 22, 26; Mot. 12.7
Plaintiffs’ remaining attempts to meet their burden of alleging an “injury in
fact” fare no better. Plaintiffs have not met the third-party standing requirement
of showing a hindrance to their patients’ ability to protect their own interests and
thus cannot rely on their patients’ alleged injuries, such as a delay in their
patients’ obtaining ivermectin because some pharmacies allegedly refused to fill
their prescriptions or insurance companies allegedly refused to pay for those
prescriptions. Mot. 14.8 Plaintiffs assert that there has been a “groundswell of
harm visited on anyone who challenges Defendants on ivermectin.” Opp’n 15.
But even if that were true, it would not demonstrate that Plaintiffs’ patients are
unable or unwilling to seek relief 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) (the “sensitivity of [AIDS patients’] identities and medical
information” was insufficient to show that those patients were “unable or
unwilling to bring” claims themselves).
Plaintiffs assert that there is a special exception to the rule against third-party
standing for “providers to invoke the rights of their actual or potential patients.”
Opp’n 14–15 (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

7 Plaintiffs’ assertion that FDA “created a new industry standard that
restricts doctors’ abilities to prescribe certain off-label treatments for COVID-19”
such as ivermectin, Opp’n 19 (quoting Ex. 28 at 2–3), is also at odds with the
Amended Complaint.
8 Defendants also argued that Plaintiffs cannot show standing based on
alleged injuries to unnamed doctors and patients. Mot. 13–15. Plaintiffs do not
respond to this argument and thus concede it. See infra p. 8.
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“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).
Plaintiffs also cannot reframe some pharmacists’ refusal to fill their patients’
ivermectin prescriptions as an injury to themselves by arguing that it delayed
their “ability to treat patients.” Opp’n 12. Plaintiffs treated their patients by
prescribing ivermectin to them, and they do not allege that they were unable to
write such prescriptions. See supra pp. 5–6. Moreover, Plaintiffs cite no authority
indicating that a doctor is injured by her patient’s inability to fill a prescription.
Indeed, courts have suggested that doctors are not injured in that circumstance.
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”).
Finally, Apter’s alleged referrals to the Arizona and Washington state
medical boards, see Am. Compl. ¶¶ 18, 121, absent any allegation that he has
actually been disciplined or that these disciplinary proceedings deprived him of
due process or caused any other concrete injury, are not an adequate injury in
fact. Mot. 13. Relying on Kiser v. Reitz, 765 F.3d 601, 608 (6th Cir. 2014), a First
Amendment case, Plaintiffs argue that a plaintiff might adequately allege an
injury in fact where he “has engaged in a course of [protected] conduct and the
state has instructed him to stop or face disciplinary action.” Opp’n 14. But
Plaintiffs’ reliance on Kiser is misplaced because they do not allege that FDA, or
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any state entity, instructed Apter to stop prescribing ivermectin to prevent or
treat COVID-19 or else face disciplinary action. Instead, Plaintiffs allege that an
unknown entity referred Apter to the two state medical boards and “include[d]”
copies of “FDA’s publications,”9 which does not show an injury in fact. Mot. 13;
Am. Compl. ¶ 18.
2. Plaintiffs Have Failed to Show that Their Alleged Injuries Are
Fairly Traceable to the Cited FDA Statements
Plaintiffs do not dispute that the cited statements “neither require[d] nor
forb[ade] any action on the part of” Plaintiffs or anyone else, Summers v. Earth
Island Inst., 555 U.S. 488, 493–94 (2009), and did not direct that Plaintiffs or
anyone else face any adverse consequences for prescribing or promoting
ivermectin to prevent or treat COVID-19. Mot. 15. Plaintiffs also do not dispute
that the Amended Complaint does not allege that Bowden’s employer’s
decisions to “deride[]” her and “force[] [her] to resign,” Am. Compl. ¶ 21, were
based on the cited FDA statements, Mot. 15. Having failed to respond to those
arguments, Plaintiffs concede them. See Ark. v. Wilmington Tr. Nat’l Ass’n, 2020
WL 1249570, at *5 (N.D. Tex. Mar. 16, 2020) (“Failure of a party to respond to
arguments raised in a motion to dismiss constitutes waiver or abandonment of
that issue at the district court level.”); Va. House of Delegates v. Bethune-Hill, 139 S.
Ct. 1945, 1951 (2019) (“[W]hen standing is questioned by . . . an opposing party,
. . . the litigant must explain how the elements essential to standing are met.”).
Plaintiffs’ remaining alleged injuries rely on an indirect causal chain, in
which the cited statements allegedly influenced the thinking of independent

9 The Amended Complaint does not say whether there were additional bases
for the referrals beyond prescribing ivermectin to treat COVID-19 or whether the
referrals were supported only by FDA’s publications.
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third parties, and those third parties then allegedly injured Plaintiffs. Mot. 15–16.
To establish traceability, Plaintiffs must show that the third-party decisions that
allegedly harmed them were a “predictable” response to the cited FDA
statements, Daves v. Dallas County, 22 F.4th 522, 543 (5th Cir. 2022) (quotations
omitted); Mot. 16, but Plaintiffs have not made that showing, Mot. 15–17.
Plaintiffs argue that those third-party actions were predictable because FDA
must have intended the cited statements to “cause such reactions.” Opp’n 16.10
But the content of the cited statements makes plain that FDA’s intent was to
inform consumers, not to influence third parties to punish individual doctors.11
See, e.g., Ex. 1 at 3–4; Ex. 2 at 2; Ex. 3 at 2; Ex. 4 at 2; Ex. 6 at 2; Ex. 19 at 3.12 The
cited statements, moreover, did not state that doctors may not prescribe human-
use ivermectin to prevent or treat COVID-19. Instead, the September 2021 article
advised consumers that “[i]f your health care provider writes you an ivermectin

10 Plaintiffs also argue that the “timing of [their] injuries immediately
following when the FDA began its pressure campaign against ivermectin in
earnest highlights the predominant role that issue played in their forced
resignations.” Opp’n 13; see also id. at 15. As an initial matter, the Amended
Complaint does not provide precise dates for Plaintiffs’ alleged injuries, let alone
allege that they “immediately follow[ed]” the cited statements. Am. Compl.
¶¶ 10–43. And even if it did, that would not mean that Plaintiffs’ alleged injuries
are traceable to the cited statements. “Post hoc ergo propter hoc is not sound
logic.” Tampa Times Co. v. NLRB, 193 F.2d 582, 583 (5th Cir. 1952).
11 For example, the cited statements do not propose or suggest any
consequences for doctors who prescribe or promote ivermectin to prevent or
treat COVID-19. It was not a predictable response to those statements for third
parties to take the actions that allegedly harmed Plaintiffs, such as forcing them
to resign. See Daves, 22 F.4th at 543.
12 As Plaintiffs note, Opp’n 16, FDA also sent a letter to two organizations to
“bring to [their] attention” information about “compounding pharmacies selling
drug products containing ivermectin, claiming that they can treat or prevent
COVID-19.” Ex. 22 at 2. The letter did not state that doctors should not prescribe
human-use ivermectin to prevent or treat COVID-19. Thus, the predictable
response to this letter would not be to punish doctors for prescribing human-use
ivermectin for their patients.
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prescription, fill it through a legitimate source such as a pharmacy, and take it
exactly as prescribed,” indicating that doctors have discretion to prescribe
ivermectin products. Ex. 1 at 3. The article likewise recommended that patients
talk to their doctors to determine their best treatment options. Ex. 1 at 4.
Likewise, the April 2020 FAQ stated that “[y]ou should not take any medicine to
treat or prevent COVID-19 unless it has been prescribed to you by your health
care provider and acquired from a legitimate source.” Ex. 2 at 2.13
Contrary to Plaintiffs’ argument, this advice was not “buried” in the cited
statements. Opp’n 17. In the FAQ, it appeared in the answer to the very first
question, “Should I take ivermectin to prevent or treat COVID-19?,” and in the
article, it appeared under the headings “Here’s What You Need to Know about
Ivermectin” and “Options for Preventing and Treating COVID-19.” Ex. 1 at 3–4;
Ex. 2 at 2. Moreover, there is no indication that a reader would not review the
entire cited statements, which are short. See, e.g., Ex. 1 (3 pages); Ex. 2 (2 pages).
Plaintiffs’ remaining arguments are equally unpersuasive. The fact that
independent third parties referenced the cited FDA statements in taking actions
that allegedly injured Plaintiffs does not show that those actions were predictable
when FDA made the cited statements. Opp’n 17–18. And even if those third
parties “are heavily influenced or feel bound by the FDA’s actions,”14 Opp’n 18;

13 Similarly, even if Plaintiffs could rely on their patients’ injuries, they still
could not show traceability. For example, Plaintiffs have not shown that it was
predictable that some pharmacies would refuse to fill ivermectin prescriptions
since the September 2021 article and April 2020 FAQ acknowledged that doctors
could prescribe ivermectin to prevent or treat COVID-19.
14 Contrary to Plaintiffs’ claim that independent third parties “feel bound” by
FDA’s recommendations, Opp’n 18, the Sentara Comprehensive COVID-19
Treatment Guidelines do not treat the cited statements as binding, Ex. 12 at 6.
Instead, they list FDA among several organizations that “have issued statements

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see also Dkt. 29-1 (“AAPS Br.”) 6–9, it would not be predictable that they would
respond to the cited statements by taking adverse action against Plaintiffs for
prescribing or promoting ivermectin to prevent or treat COVID-19. As discussed
above, the September 2021 article and April 2020 FAQ acknowledged doctors’
discretion to prescribe ivermectin for that purpose. Ex. 1 at 3–4; Ex. 2 at 2.15
Plaintiffs argue that courts have “cit[ed] the FDA’s statements as evidence
about the effectiveness of ivermectin to treat COVID-19 and the appropriate
standard of care” and “rel[ied] on those same statements and ‘guidance’ to
determine legal standards.” Opp’n 18. But the decisions Plaintiffs cite did not
treat FDA’s statements as dispositive; for example, they considered them
together with statements by other organizations. See, e.g., DeMarco v. Christiana
Care Health Servs., Inc., 263 A.3d 423, 435 (Del. Ch. 2021) (observing that
“[t]reating COVID-19 with ivermectin is undisputedly contrary to generally
accepted health care standards” and that “[p]reeminent institutions representing
numerous facets of the national medical establishment, including the FDA, [the
Centers for Disease Control and Prevention (“CDC”)], [the American Medical
Association], World Health Organization, and Infectious Disease Society of
America, have criticized the use of ivermectin as a treatment for COVID-19”).16

recommending against the use of ivermectin for prevention or treatment of
COVID-19,” and they provide independent scientific reasons supporting that
recommendation. Ex. 12 at 6.
15 The cited tweets included links to the article. See Ex. 4; Ex. 7.
16 The cases that the Association of American Physicians and Surgeons
(“AAPS”) cites in its amicus brief for the same purpose, AAPS Br. 6–7, also do
not rely solely on FDA’s statements. See, e.g., Frey ex rel. Frey v. Health-Michigan,
No. 359446, 2021 WL 5871744, at *1 (Mich. Ct. App. Dec. 10, 2021) (noting that
FDA “has not approved ivermectin for use in treating COVID-19,” that CDC
“recommends against its use to treat COVID-19” and that “defendants’ internal
policy does not permit the use of ivermectin to treat COVID-19”).
Case 3:22-cv-00184 Document 42 Filed on 10/21/22 in TXSD Page 17 of 30

3. Plaintiffs Have Failed to Show that Their Alleged Injuries Are
Likely Redressable by the Requested Relief
Plaintiffs fail to respond to and thus concede Defendants’ arguments that
they have not shown redressability regarding Marik and Bowden. See Wilmington
Tr., 2020 WL 1249570, at *5; Va. House of Delegates, 139 S. Ct. at 1951. Marik’s state
medical licenses are expired, and he has not alleged any intention to renew them.
See Mot. 20. Also, Marik and Bowden were allegedly forced to resign for reasons
other than prescribing or promoting ivermectin to prevent or treat COVID-19. See
id. Plaintiffs also fail to respond to, and thus concede, Defendants’ argument that
Plaintiffs’ requested declaration that the cited FDA statements “have no legal
effect and do not bind health professionals or patients,” Am. Compl. at 44, could
not redress Plaintiffs’ injuries because the cited statements were purely
informational and did not purport to have any “legal effect.” Mot. 19–20.
Plaintiffs incorrectly assert that redressability is “presumed” upon a finding
of traceability, and they similarly argue that the fact that third parties have
referenced FDA’s statements supports redressability. Opp’n 20, 22. Although the
traceability and redressability analyses sometimes overlap, the concepts are
distinct and do not always point in the same direction. For example, even if
governmental action is a “contributing factor in bringing about a specific harm,”
there is no redressability where “the undoing of the governmental action will not
undo the harm[] because the new status quo is held in place by other forces.”
Renal Physicians Ass’n v. U.S. Dep’t of Health & Hum. Servs., 489 F.3d 1267, 1278
(D.C. Cir. 2007). Here, even if the Court granted Plaintiffs’ requested relief,
Plaintiffs have not shown that the third parties that allegedly harmed them, such
as their former employers, would likely reverse course, such as by rehiring them.
Case 3:22-cv-00184 Document 42 Filed on 10/21/22 in TXSD Page 18 of 30

Contra Opp’n 22. Also, Marik can no longer practice medicine because he has no
valid medical license. Moreover, Plaintiffs have not plausibly alleged that it is
likely that any third parties would change their scientific understanding of the
risks and benefits of using ivermectin to prevent or treat COVID-19 or the actions
they took based on that understanding that allegedly harmed Plaintiffs. Mot. 18–
19. This argument is not a “red herring,” Opp’n 22: even if the cited statements
were taken down, many other organizations have made statements advising
against the use of ivermectin to prevent or treat COVID-19, such as Merck (the
sponsor of Stromectol® (ivermectin)), CDC, the National Institutes of Health,
and the World Health Organization. Mot. 19 (citing Ex. 12 at 6; Ex. 25; Am.
Compl. ¶¶ 102–08).17 In fact, Sentara, the hospital that formerly employed Marik,
relied on Merck’s statement, among others, in forming its conclusions about the
use of ivermectin to prevent or treat COVID-19. Ex. 12 at 6.
Plaintiffs’ argument that their requested relief would cause the medical
community to “revert to th[e] norm” of supporting the off-label prescription of
approved drugs, Opp’n. 21–22, is inapposite. The attitudes of third parties
toward off-label prescription in general are irrelevant; what matters is what third
parties will do regarding prescribing ivermectin to prevent or treat COVID-19.
Just as the alleged interference with the practice of medicine, by itself, is too
vague and abstract to show a concrete injury, Plaintiffs’ argument that the
requested relief would remove such interference, Opp’n 21–22, is too vague and

17 For example, even if Apter’s referrals to state medical boards were an
adequate injury, and even if “redressability is satisfied where the ‘fear of future
prosecution may be alleviated’ by a favorable ruling,” Opp’n 21, Plaintiffs still
have not shown redressability because it is speculative how the requested relief
might affect the state medical boards’ future resolution of those referrals.
Case 3:22-cv-00184 Document 42 Filed on 10/21/22 in TXSD Page 19 of 30

abstract to show redressability. As discussed above, Plaintiffs have not shown
that their ability to prescribe ivermectin was ever impaired, and thus there is no
such injury to redress. And even if the cited statements exerted pressure on
Plaintiffs’ professional judgment, Opp’n 21, Plaintiffs have not alleged that such
pressure ever prevented them from prescribing ivermectin to prevent or treat
COVID-19. Thus, taking down the cited statements and removing whatever
pressure such statements generate would not redress any injuries. Mot. 18 n.16.
Plaintiffs also cannot show redressability regarding alleged injuries to their
patients. See Opp’n 21–22. Even if Plaintiffs could rely on these alleged injuries to
show an injury in fact, they still have not shown redressability because they have
not shown that pharmacies, insurance companies, or the patients themselves
would likely change their scientific understanding of the risks and benefits of
using ivermectin to prevent or treat COVID-19 or the actions they took based on
that understanding. See supra p. 13. In arguing that their “[p]atients will no
longer be caught between the FDA’s pressure campaign and Plaintiffs’ advice,”
Opp’n 21, Plaintiffs ignore that many other organizations have issued public
statements advising against the use of ivermectin to prevent or treat COVID-19.
The amicus briefs of AAPS and America’s Frontline Doctors (“AFLDS”)
largely focus on the merits rather than standing. See AAPS Br.; Dkt. 35-1
(“AFLDS Br.”)). And although AAPS cites several cases in support of Plaintiffs’
standing, these cases are inapposite. In Tozzi v. U.S. Department of Health and
Human Services, 271 F.3d 301, 307 (D.C. Cir. 2001), see AAPS Br. 10–11, the court
held that a manufacturer of dioxin products had standing to challenge an agency
report that classified dioxin as a “known” carcinogen under a classification
Case 3:22-cv-00184 Document 42 Filed on 10/21/22 in TXSD Page 20 of 30

scheme mandated by statute, and which was intended by Congress “to serve as
the federal government’s authoritative statement” on the carcinogenicity of
various chemicals. Id. at 309. The classification followed an elaborate process that
included publication in the Federal Register and public hearings, and it triggered
legal obligations under federal and state regulations. Id. at 304, 308, 310. The
court observed that the classification would likely lead “state and local agencies
to regulate products containing dioxin” and “healthcare companies to reduce or
end purchases of” those products, especially since the term “carcinogen” is
“inherently pejorative and damaging.” Id. at 309. Additionally, no other federal
agency had labeled dioxin a “known” carcinogen. Id. at 309–10.
Here, by contrast, the cited statements provide nonbinding
recommendations, and Plaintiffs do not allege that they automatically triggered
legal obligations under federal or state law. Moreover, Plaintiffs have not shown
that third parties would likely respond to the cited statements by taking the
actions that allegedly harmed Plaintiffs. See supra pp. 12–14. Furthermore, the
more nuanced message of the September 2021 article and the April 2020 FAQ,
acknowledging doctors’ discretion to prescribe ivermectin to prevent or treat
COVID-19, is unlike the unambiguously negative designation “known”
carcinogen. And other federal agencies, such as CDC, have recommended
against the use of ivermectin to prevent or treat COVID-19. See supra p. 13.
Similarly inapposite is Meese v. Keene, 481 U.S. 465 (1987), see AAPS Br. 11,
which held that the plaintiff had standing to challenge the government’s
classification of films as “political propaganda” because that classification would
likely harm Plaintiffs’ reputation if he exhibited the films. Id. at 472–77. Here, the
Case 3:22-cv-00184 Document 42 Filed on 10/21/22 in TXSD Page 21 of 30

cited statements do not say that doctors should not prescribe ivermectin to
prevent or treat COVID-19. Finally, contrary to AAPS’s assertion that Community
for Creative Non-Violence v. Pierce (“CCNV”), 814 F.2d 663 (D.C. Cir. 1987), “found
that homeless men had standing to challenge” an agency report “based on the
likelihood of being turned away from a homeless shelter due to it,” AAPS Br. 9–
10, the court held that these plaintiffs failed to show traceability or redressability.
CCNV, 814 F.2d at 666–70.
B. Plaintiffs Have Not Met Their Burden to Show a Waiver of Sovereign
Immunity
“It is axiomatic that the United States may not be sued without its consent
and that the existence of consent is a prerequisite for jurisdiction.” United States v.
Mitchell, 463 U.S. 206, 212 (1983). Plaintiffs argue that they do not need to show a
waiver of sovereign immunity with respect to Count One because it is an “ultra
vires claim” and that, regardless, the Court has jurisdiction over all of their
claims because Plaintiffs have met the requirements for the APA’s waiver of
sovereign immunity. Opp’n 23–28. Both arguments are meritless.
First, Plaintiffs argue that they do not need to show a waiver of sovereign
immunity for Count One because FDA acted “without any authority whatever.”
Opp’n 23–24. Plaintiffs invoke the ultra vires doctrine, which is “intended to be
of extremely limited scope.” Griffith v. FLRA, 842 F.2d 487, 493 (D.C. Cir. 1988)
(emphasis added). A plaintiff’s mere “claim of error” is “not sufficient” to
establish a court’s jurisdiction on an ultra vires theory. Larson v. Domestic &
Foreign Com. Corp., 337 U.S. 682, 690 (1949). Rather, a plaintiff must “allege facts
sufficient to establish” that the government acted “‘without any authority
whatever,’ or without any ‘colorable basis for the exercise of authority.’” Danos v.
Case 3:22-cv-00184 Document 42 Filed on 10/21/22 in TXSD Page 22 of 30

Jones, 652 F.3d 577, 583 (5th Cir. 2011) (quoting Pennhurst State Sch. & Hosp. v.
Halderman, 465 U.S. 89, 101 n.11 (1984)).
Here, Plaintiffs have not made the required showing that FDA lacked “any
authority whatever” or a “colorable basis” to make the cited statements. Id. They
do not argue that FDA lacks the authority to make public statements in general.
Plaintiffs instead argue that FDA’s authority to make the cited statements is
limited by 21 U.S.C. § 396, a provision that is directed to devices, not drugs, and
does not implicate FDA’s communications. See Opp’n 24; supra pp. 3–5. Plaintiffs
have thus not met the demanding standard required to review Count One under
the “extremely limited” ultra vires doctrine. Griffith, 842 F.2d at 493.
Second, the APA’s waiver of sovereign immunity is not available for any of
Plaintiffs’ claims. As an initial matter, Plaintiffs assert that an agency’s “purely
informational statements” meet the APA’s definition of a “rule” and are
therefore reviewable agency action. Opp’n 24–28. Although Plaintiffs note the
definition is broad, id., it is not boundless and does not apply to the cited
statements. Agencies “make rules when they announce principles of general
applicability and future effect.” Walmart Inc. v. U.S. Dep’t of Just., 21 F.4th 300, 308
(5th Cir. 2021) (applying 5 U.S.C. § 551(4)). The cited statements did no such
thing: they did not “appl[y]” to any particular party and did not purport to have
any “future effect.” 5 U.S.C. § 551(4). Instead, they provided nonbinding
recommendations to the public at large.18 Plaintiffs do not argue that the cited

18 The Fifth Circuit cases Plaintiffs cite in support of their agency action
argument are inapt. See Opp’n 24–25. Avoyelles Sportsmen’s League, Inc. v. Marsh
concerned whether the EPA had engaged in legislative or interpretative
rulemaking, not whether the determination at issue met the definition of “rule.”
715 F.2d 897, 908–09 (5th Cir. 1983). The agency action requirement was not at

Case 3:22-cv-00184 Document 42 Filed on 10/21/22 in TXSD Page 23 of 30

statements meet the definition of any other kind of agency action, thus, the
APA’s waiver of sovereign immunity does not apply.
Even if Plaintiffs could adequately allege “agency action,” they still fail to
adequately allege that the cited statements caused them to suffer a “legal wrong”
or an “adverse[] affect[].” Alabama-Coushatta Tribe of Tex. v. United States, 757 F.3d
484, 489 (5th Cir. 2014) (citing 5 U.S.C. § 702). As discussed above, Plaintiffs have
not alleged a concrete injury that is fairly traceable to the cited statements. See
supra pp. 2–11; contra Opp’n 25.
As to the APA claims, Plaintiffs have failed to show a waiver of sovereign
immunity for the additional reason that the cited statements do not meet either
requirement for “final” agency action. See Alabama-Coushatta, 757 F.3d at 488–89.
First, the statements did not reflect the consummation of the agency’s
decisionmaking process as to any issue. Bennett v. Spear, 520 U.S. 154, 178 (1997).
Even Plaintiffs characterize the March 2021 version of the article (Exhibit 19) as a
“first draft,” Opp’n 17, and rather than stating FDA’s definitive, final position on
the use of ivermectin to prevent or treat COVID-19, the statements were
expressly tentative: they were based on “[c]urrently available data,” said that
“[a]dditional testing is needed,” and indicated that “[c]linical trials” are
“ongoing.” Ex. 1 at 3; Ex. 2 at 2. Plaintiffs’ attempt to show finality regarding the
other statements cherry picks sections of the cited statements and ignores the
many sections that reflect FDA’s tentative position. See Opp’n 26.
A final agency action must also “be one by which rights or obligations have

issue in Data Marketing Partnership, LP v. U.S. Department of Labor, so the court’s
reference to a Department of Labor information letter being “non-final agency
action” sheds no light on whether the cited statements here constituted agency
action. 45 F.4th 846, 855 (5th Cir. 2022).
Case 3:22-cv-00184 Document 42 Filed on 10/21/22 in TXSD Page 24 of 30

been determined, or from which legal consequences will flow.” Bennett, 520 U.S.
at 178 (quotation omitted). In Data Marketing Partnership, LP v. U.S. Department of
Labor, for example, the plaintiffs challenged a Department of Labor advisory
opinion that “bound” the agency and “withdrew its previously held discretion,”
which was “textbook final agency action.” 45 F.4th 846, 854 (5th Cir. 2022). The
court contrasted the advisory opinion with “information letters,” which were not
final because they were “informational only” and did not bind the agency. Id. at
855. Like the information letters in Data Marketing, the cited statements here were
not final because they were informational only and did not narrow FDA’s
discretion or bind the agency in any way.
Without citing any authority, Plaintiffs contend that “legally binding effects
are not necessary to render agency action ‘final’ for the purposes of judicial
review when the action in question is expressly prohibited by the statute
regardless of such effects.” Opp’n 27. But final agency action must “be one by
which rights or obligations have been determined, or from which legal
consequences will flow.” Bennett, 520 U.S. at 178 (quotation omitted). This
standard is not necessarily met simply because a statute has allegedly been
violated. Plaintiffs have not plausibly alleged such a violation. See supra pp. 3–5.
Plaintiffs also argue that, even without “direct consequences,” the cited
statements were “binding as a practical matter” and “thus final” because they
“dictate[d] a ‘norm,’” and private parties could be “reasonably led to believe that
failure to conform” to that norm would “bring adverse consequences.” Opp’n
26–27 (quoting Texas v. EEOC, 933 F.3d 433, 442 (5th Cir. 2019)). In EEOC, the
Fifth Circuit held that an agency guidance document can be “final” if the agency
Case 3:22-cv-00184 Document 42 Filed on 10/21/22 in TXSD Page 25 of 30

creates a “norm or safe harbor,” where the agency can take adverse action against
a private party if that party fails to comply with the norm. 933 F.3d at 442–44; see
also, e.g., U.S. Army Corps of Eng’rs v. Hawkes Co., 578 U.S. 590, 597–99 (2016).
Here, by contrast, Plaintiffs do not allege that the cited statements caused them to
fear enforcement by FDA, but instead allege that third parties might take adverse
actions against them if they fail to comply with the purported “norms.” FDA’s
statements are not “binding as a practical matter” simply because third parties
might independently decide to take adverse actions against parties that do not
comply with them. EEOC, 933 F.3d at 442. The legal consequences relevant to the
analysis laid out in EEOC flow from the agency to third parties, not independent
third parties to other third parties. Id.
Plaintiffs’ and the amici’s position is all the less credible because they argue
that doctors’ authority to prescribe approved drugs for unapproved uses is well
established. See Opp’n 3-4; AAPS Br. 3; AFLDS Br. 4. Plaintiffs cannot plausibly
argue that anyone could “reasonably believe” that FDA effectuated a binding
change to that well-established practice through a tweet saying “You are not a
horse. You are not a cow. Seriously, y’all. Stop it,” a similar Instagram post, or an
article containing recommendations and no mandatory language. In short, the
cited statements did not purport to alter the existing “legal regime.” Contra
Opp’n 27 (citing State v. Biden, 10 F.4th 538, 550 (5th Cir. 2021)).
Finally, while Plaintiffs assert that the “effects” of agency action need not
“direct[ly]” affect them, Opp’n 27, the supposed “norm” they cite did not have a
legal effect on anyone. For example, the September 2021 article acknowledged
that doctors have discretion to prescribe ivermectin for preventing or treating
Case 3:22-cv-00184 Document 42 Filed on 10/21/22 in TXSD Page 26 of 30

COVID-19, see Ex. 1 at 3–4, which underscores how Plaintiffs’ alleged injuries
resulted from private, third-party decisions.
II. Plaintiffs Forfeited Their Arguments by Declining to Raise Them With
FDA Prior to Filing this Lawsuit
Even if the Court had jurisdiction, the Amended Complaint should be
dismissed because the issues raised therein were never presented to FDA for
administrative resolution. Contrary to Plaintiffs’ claim, Defendants did not argue
that Plaintiffs should be “required to raise their claims through a ‘citizen
petition’” or any particular administrative remedy. Opp’n 28. Instead,
Defendants invoked the principle of “issue exhaustion” and argued that,
regardless of the method, “the agency should be given the first chance” to apply
its expertise and discretion to the issues raised in the Amended Complaint. Mot.
28–29 (quoting McKart v. United States, 395 U.S. 185, 194 (1969)). As discussed in
Defendants’ motion, the Fifth Circuit recently applied issue exhaustion in Palm
Valley Health Care v. Azar, 947 F.3d 321 (5th Cir. 2020). Mot. 29.
As in Palm Valley, Plaintiffs failed to present a question to the agency prior to
litigation and that, as a result, the court “cannot consider [that] question.” Id. at
328. Plaintiffs make no attempt to distinguish that case. Nor do they contest the
many benefits of issue exhaustion. See Mot. 28–29.
Instead, Plaintiffs argue that the citizen petition process “do[es] not apply” to
their ultra vires claim because FDA only “has primary jurisdiction to make the
initial determination on issues within its statutory mandate.” Opp’n 28 (quoting
21 C.F.R. § 10.25(b)). But the provision Plaintiffs cite is not a limitation on the
Citizen Petition process and, contrary to Plaintiffs’ suggestion (Opp’n 29), it
strains credulity that Plaintiffs’ requested relief, such as removing an article,
Case 3:22-cv-00184 Document 42 Filed on 10/21/22 in TXSD Page 27 of 30

would fail to qualify as “any . . . form of administrative action” under 21 C.F.R.
§ 10.25(a). See also Koretoff v. Vilsack, 707 F.3d 394, 397–98 (D.C. Cir. 2013).
Similarly, Plaintiffs’ unsupported argument that the citizen petition process “is
aimed at scenarios” where a party can petition FDA before the agency takes
action, Opp’n 29, is incorrect: the citizen petition process has been used to ask
FDA to reconsider decades-old positions and actions, including its position on
the scope of its own authority. See, e.g., Henley v. FDA, 77 F.3d 616 (2d Cir. 1996);
Action on Smoking & Health v. Harris, 655 F.2d 236 (D.C. Cir. 1980). Plaintiffs
further argue that the “ongoing negative effects” of the cited statements warrant
“prompt judicial review,” Opp’n 30, but they ignore the 26 months that elapsed
between the first statement Plaintiffs cite (Ex. 2) and the date they filed this
lawsuit, time which could have been used to raise their issues directly to FDA.
Plaintiffs further assert that requiring them to present their claims to FDA
would violate 5 U.S.C. § 704 because it would “in effect” require them to pursue
a “form of reconsideration.” Opp’n 30. But that section concerns whether an
agency action is “final,” 5 U.S.C. § 704, not the question of issue exhaustion.
If the Court concludes it has subject matter jurisdiction, and as an alternative
to dismissal on issue exhaustion grounds, Defendants would not object to a stay
of this case to allow Plaintiffs to present their issues to FDA for administrative
resolution in the first instance.
CONCLUSION
For the foregoing reasons, and those stated in Defendants’ motion, the
Amended Complaint should be dismissed for lack of subject matter jurisdiction
or, in the alternative, for failure to state a claim.
Case 3:22-cv-00184 Document 42 Filed on 10/21/22 in TXSD Page 28 of 30

October 21, 2022

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 (McDonald)

(202) 514-8742 (fax)

Isaac.C.Belfer@usdoj.gov

Oliver.J.McDonald@usdoj.gov

Counsel for Defendants
Case 3:22-cv-00184 Document 42 Filed on 10/21/22 in TXSD Page 29 of 30

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.

October 21, 2022

/s/ Isaac C. Belfer

Isaac C. Belfer

Case 3:22-cv-00184 Document 42 Filed on 10/21/22 in TXSD Page 30 of 30

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Defendants' Reply in Support of Motion to Dismiss — Apter v. HHS (Oct. 21, 2022)

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