Court filing

Plaintiffs' Opposition to Renewed Motion to Dismiss — Apter v. HHS (Jan. 12, 2024) (S.D. Tex.)

Filed January 12, 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	2024-01-12

U.S. District Court for the Southern District of Texas, Galveston Division · No. 3:22-cv-00184 · Doc. 61 · 2024-01-12 · Docket on CourtListener

Full text

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

ROBERT L. APTER, M.D., FACEP; MARY
TALLEY BOWDEN, M.D.; and PAUL E.
MARIK, MBBCh, M.MED, FCCM, FCCP,

Plaintiffs,

DEPARTMENT OF HEALTH AND HUMAN
SERVICES; XAVIER BECERRA, in his
official capacity as Secretary of Health and
Human Services; FOOD AND DRUG
ADMINISTRATION; and ROBERT M.
CALIFF, M.D., MACC, in his official capacity
as Commissioner of Food and Drugs,

Defendants.

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PLAINTIFFS’ OPPOSITION TO DEFENDANTS’ RENEWED MOTION TO
DISMISS THE AMENDED COMPLAINT

Case 3:22-cv-00184 Document 61 Filed on 01/12/24 in TXSD Page 1 of 39

TABLE OF CONTENTS

TABLE OF CONTENTS ............................................................................................................ ii
TABLE OF AUTHORITIES ..................................................................................................... iii
INTRODUCTION ........................................................................................................................ 1
BACKGROUND .......................................................................................................................... 3
I.
FDA’s Statutory Authority .......................................................................................3
II. FDA Campaign Against Ivermectin .........................................................................6
III. Procedural History ..................................................................................................10
STANDARD OF REVIEW ...................................................................................................... 11
SUMMARY OF THE ARGUMENT ...................................................................................... 12
ARGUMENT .............................................................................................................................. 12
I.
Plaintiffs Have Been Injured ..................................................................................13
A. Interference in the Practice of Medicine .............................................................13
B. Economic Harm ..................................................................................................17
C. Increased Exposure to Malpractice Liability ......................................................18
D. Reputational Harm ..............................................................................................18
E. Disciplinary Proceedings and Forced Resignations ............................................19
II. Plaintiffs’ Injuries Are Fairly Traceable to the FDA ..............................................21
III. Plaintiffs’ Injuries Are Redressable ........................................................................28
CONCLUSION ........................................................................................................................... 30

Case 3:22-cv-00184 Document 61 Filed on 01/12/24 in TXSD Page 2 of 39

iii

TABLE OF AUTHORITIES

Page(s)
Cases
Abbinanti v. Presence Cent. & Suburb. Hosps. Network,
2021 IL App. (2d) 210763 (2021) ............................................................................ 9, 27
Allen v. Wright,
468 U.S. 737 (1984) ..................................................................................................... 13
Animal Legal Def. Fund v. Veneman,
469 F.3d 826 (9th Cir. 2006) ........................................................................................ 29
Apter v. Dep’t of Health & Hum. Servs.,
644 F.Supp.3d 361 (2022) ............................................................................................ 14
Apter v. Dep’t of Health & Hum. Servs.,
80 F.4th 579 (5th Cir. 2023) ............................................. 2, 6, 10, 11, 15, 23, 25, 26, 27
Ass’n of Am. Physicians & Surgeons v. FDA,
13 F.4th 531, 534 (6th Cir. 2021) ................................................................................ 11
Ass’n of Am. Physicians & Surgeons v. Tex. Med. Bd.,
627 F.3d 547 (5th Cir. 2010) ........................................................................................ 11
Buckman Co. v. Plaintiffs’ Legal Comm.,
531 U.S. 341 (2001) ....................................................................................................... 5
Carter v. HealthPort Techs.,
LLC, 822 F.3d 47 (2d Cir. 2016) ................................................................................. 12
Clapper v. Amnesty Int’l USA,
568 U.S. 398 (2013) ..................................................................................................... 28
Cmty. For Creative Non–Violence v. Pierce,
814 F.2d 663 (D.C. Cir. 1987) ..................................................................................... 21
D.J.C. for D.A.C. v. Staten Island Univ. Hosp.-Northwell Health,
157 N.Y.S.3d 667 (2021) ............................................................................. 9, 18, 27, 30
DeMarco v. Christiana Care Health Servs., Inc.,
263 A.3d 423 (Del. Ch. 2021) .................................................................................. 9, 27
Case 3:22-cv-00184 Document 61 Filed on 01/12/24 in TXSD Page 3 of 39

Dep’t of Com. v. New York,
139 S. Ct. 2551 (2019) ....................................................................................... 3, 13, 21
Friends of the Earth, Inc. v. Laidlaw Env’t. Servs. (TOC), Inc.,
528 U.S. 167 (2000) ............................................................................................... 13, 28
Gahl v. Aurora Health Care, Inc.,
977 N.W.2d 756 (Wis. Ct. App. 2022) .......................................................................... 9
Garcia v. Home Depot U.S.A., Inc.,
1999 WL 362787 (N.D. Tex. June 2, 1999) ................................................................. 17
In re Gilead Sci. Sec. Litig.,
536 F.3d 1049 (9th Cir. 2008) ...................................................................................... 14
Green v. Brennan,
578 U.S. 547 (2016) ..................................................................................................... 21
Hollingsworth v. Perry,
570 U.S. 693 (2013) ..................................................................................................... 13
Judge Rotenberg Educ. Ctr., Inc. v. FDA,
3 F.4th 390 (D.C. Cir. 2021) ...................................................................................... 4, 5
June Med. Servs. L.L.C. v. Russo,
140 S. Ct. 2103 (2020) ................................................................................................. 16
U.S. ex rel. King v. Solvay Pharms., Inc.,
871 F.3d 318 (5th Cir. 2017) .................................................................................... 1, 14
Kiser v. Reitz,
765 F.3d 601 (6th Cir. 2014) ........................................................................................ 20
Lane v. Halliburton,
529 F.3d 548 (5th Cir. 2008) ........................................................................................ 12
Lexmark Int’l, Inc. v. Static Control Components, Inc.,
572 U.S. 118 (2014) ..................................................................................................... 21
Lujan v. Defs. of Wildlife,
504 U.S. 555 (1992) ..................................................................................................... 26
Markland v. Insys Therapeutics, Inc.,
758 F. App’x 777 (11th Cir. 2018) .............................................................................. 14
Case 3:22-cv-00184 Document 61 Filed on 01/12/24 in TXSD Page 4 of 39

McClure v. Ashcroft,
335 F.3d 404 (5th Cir. 2003) ........................................................................................ 30
Med. Mut. of Ohio v. AbbVie Inc.,
784 F. App’x 457 (7th Cir. 2019) ................................................................................ 14
Missouri v. Biden,
83 F.4th 350 (5th Cir. 2023) ......................................................................................... 21
Moore & Assocs. v. Metro. Life Ins. Co.,
604 S.W. 2d 487 (Tex. Civ. App. 1980) ...................................................................... 17
U.S. ex rel. Nathan v. Takeda Pharms. N. Am., Inc.,
707 F.3d 451 (4th Cir. 2013) ........................................................................................ 14
OCA-Greater Hous. v. Texas,
867 F.3d 604 (5th Cir. 2017) ........................................................................................ 13
Physicians for Integrity in Medical Research, Inc. v. Ostroff,
670 F. App’x 450 (9th Cir. 2016) ................................................................................ 23
Planned Parenthood Cincinnati Region v. Taft,
444 F.3d 502 (6th Cir. 2006) .......................................................................................... 5
U.S. ex rel. Polansky v. Pfizer, Inc.,
822 F.3d 613 (2d Cir. 2016) ......................................................................................... 14
Regents of the Univ. of Cal. v. Aisen,
2016 WL 1428072 (S.D. Cal. Apr. 12, 2016) .............................................................. 17
Rieves v. Town of Smyrna,
67 F.4th 856 (6th Cir. 2023) ......................................................................................... 24
Sanchez v. R.G.L.,
761 F.3d 495 (5th Cir. 2014) .................................................................................. 28, 30
In re Schering Plough Corp. Intron/Temodar Consumer Class Action,
678 F.3d 235 (3d Cir. 2012) ........................................................................................... 5
Shoemaker v. UPMC Pinnacle Hosps.,
283 A.3d 885 (Pa. 2022) ................................................................................................ 9
Sierra Club v. Dep’t of Interior,
899 F.3d 260 (4th Cir. 2018) ........................................................................................ 24
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Singleton v. Wulff,
428 U.S. 106 (1976) ..................................................................................................... 16
Smith v. West Chester Hosp.,
LLC, 2021 WL 4129083 (Ohio Ct. Com. Pl. Sept. 6, 2021) ................................... 9, 27
Spokeo, Inc. v. Robins,
578 U.S. 330 (2016) ..................................................................................................... 14
Superior MRI Servs., Inc. v. All. Healthcare Servs., Inc.,
778 F.3d 502 (5th Cir. 2015) ........................................................................................ 12
Tozzi v. HHS,
271 F.3d 3019 (D.C. Cir. 2001) ................................................................................... 21
TransUnion LLC v. Ramirez,
594 U.S. 413 (2021) ................................................................................... 14, 16, 17, 18
Trump v. IRAP,
582 U.S. 571 (2017) ..................................................................................................... 13
United States v. Caronia,
703 F.3d 149 (2nd Cir. 2012) ................................................................................. 13, 14
United States v. Muoghalu,
662 F.3d 908 (7th Cir. 2011) ........................................................................................ 14
Wash. Legal Found. v. Henney,
202 F.3d 331 (D.C. Cir. 2000) ....................................................................................... 5
Statutes
21 U.S.C. § 333 .................................................................................................................... 4
21 U.S.C. § 355 .................................................................................................................... 3
21 U.S.C. § 396 .................................................................................................................. 14
Other Authorities
Phoebe Carter, Liability for Interference with Physician-Patient Relationship,
87 A.L.R. 4th 845 (1991) ............................................................................................. 17
Donna T. Chen et al., U.S. Physician Knowledge of the FDA-Approved
Indications and Evidence Base for Commonly Prescribed Drugs: Results of
a National Survey, 18 Pharmacoepidemiology & Drug Safety 1094 (2009) ................. 4
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vii

Food & Drug Admin., “Off-Label” and Investigational Use of Marketed Drugs,
Biologics, and Medical Devices (Jan. 1998), http://tinyurl.com/4etfhhpy. ................... 4
Stephanie Greene, False Claims Act Liability for Off-Label Promotion of
Pharmaceutical Products, 110 Penn. St. L. Rev. 41, 46 (2005). ................................... 4

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INTRODUCTION
The U.S. Food and Drug Administration (“FDA”) is a gatekeeper with authority to
“approve” when a drug can be introduced to the market in the United States and what
labeling it can use. Once approved, “the FDA does not restrict physicians from prescribing
an otherwise FDA-approved drug for an off-label use.” U.S. ex rel. King v. Solvay Pharms.,
Inc., 871 F.3d 318, 328 (5th Cir. 2017). Off-label use is not only “common,” but it may “in
many cases . . . represent the standard of care in the industry.” Id. (cleaned up).
The FDA also cannot direct or advise how doctors should prescribe, or patients
should take, an approved drug. Those decisions fall within the scope of the doctor-patient
relationship. Attempts by the FDA to influence or intervene in the doctor-patient
relationship constitute interference with the practice of medicine, the regulation of which
is—and always has been—reserved to states.
The FDA exceeded its authority by repeatedly issuing public directives not to use
ivermectin for COVID-19, even though the drug remains fully approved for human use.
This includes a publication titled, “Why You Should Not Use Ivermectin to Treat or
Prevent COVID-19,” Ex.1,1 to which the FDA linked in a letter to the Federation of State
Medical Boards and which on its face seeks to interfere with a decision that is preserved
for the doctor-patient relationship. Other FDA directives are even more blunt, stating: “Q:
Should I take ivermectin to prevent or treat COVID-19? A: No,” Exs.2, 3; and “You are
not a horse. You are not a cow. Seriously, y’all. Stop it,” Ex.4; and “You are not a horse.

1 Exhibits (“Ex.”) 1–28 are attached to the Amended Complaint. Exhibits 29–30 are sub-
mitted with this brief.
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Stop it with the #Ivermectin. It’s not authorized for treating #COVID,” Ex.6. The FDA has
never withdrawn any of these publications and almost all remain active on official FDA
platforms, some for nearly three years.
Plaintiffs in this case—Dr. Robert L. Apter, Dr. Mary Talley Bowden, and Dr. Paul
E. Marik—sued the FDA2 for non-monetary equitable relief, alleging its actions were ultra
vires and violated the Administrative Procedure Act (“APA”). This Court dismissed those
claims as barred by sovereign immunity, but the Fifth Circuit held on appeal that the ultra
vires claim could proceed. The Fifth Circuit explained that the “FDA is not a physician”
and has not identified “any authority that allows it to issue recommendations or give
medical advice.” Apter v. Dep’t of Health & Hum. Servs., 80 F.4th 579, 583 (5th Cir. 2023).
The FDA “has not offered even a ‘colorable basis’” for its actions. Id. at 588. While “[i]t
has authority to inform, announce, and apprise,” it cannot “endorse, denounce, or advise,”
and “[e]ven tweet-sized doses of personalized medical advice are beyond FDA’s statutory
authority.” Id. at 595. The Court therefore concluded that Plaintiffs “have plausibly alleged
that FDA’s [actions] fell on the wrong side of the line between telling about and telling to,”
so sovereign immunity does not bar their ultra vires claim. Id. at 595.
On remand, the FDA renewed a previous motion to dismiss for lack of standing,
arguing that Plaintiffs have not suffered concrete injuries that are fairly traceable to the
FDA and can be remedied by a favorable decision. The FDA is wrong. Plaintiffs have
suffered interference with their practice of medicine and the doctor-patient relationship,

2 Plaintiffs sued the FDA, the Department of Health and Human Services (“HHS”), the
Secretary of HHS, and the Commissioner of Food and Drugs (collectively, “the FDA”).
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economic harm, reputational harm, and increased exposure to malpractice liability, and
have been subject to disciplinary proceedings and forced resignations, all of which clearly
trace to the FDA’s campaign against ivermectin and would be remedied by equitable relief.
Common sense confirms that the only reason the FDA would issue its ivermectin
publications in the first place is because of the predictable and intended effects they would
have on healthcare professionals, regulatory boards, hospitals, patients, and the broader
public to stop the use of ivermectin to treat COVID-19—precipitating the very harms
Plaintiffs have experienced. The FDA plainly desired that end, or the entire endeavor would
have been pointless. But now the FDA argues that its actions had no effect, lacked even
plausible traceability to their intended outcome, and cannot be remedied.
Judges “are not required to exhibit a naiveté from which ordinary citizens are free.”
Dep’t of Com. v. New York, 139 S. Ct. 2551, 2575–76 (2019). The FDA cannot use
unlawful means to accomplish its objectives and then wash its hands of the consequences.
The motion to dismiss should be denied.
BACKGROUND
I.
FDA’s Statutory Authority
The FDA has authority under the Federal Food, Drug, and Cosmetic Act (FDCA)
to approve a drug “for introduction into interstate commerce” if the agency determines the
drug is “safe for use under the conditions prescribed, recommended, or suggested in the
proposed labeling thereof,” and there is “substantial evidence that the drug will have the
effect it purports or is represented to have under the conditions of use prescribed,
recommended, or suggested in the proposed labeling thereof.” 21 U.S.C. § 355(a), (d).
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Once approved, doctors are free to prescribe these drugs for “off-label” purposes.
“Off-label prescription of drugs is common, with as many as forty percent of all
prescriptions issued involving off-label use.” Stephanie Greene, False Claims Act Liability
for Off-Label Promotion of Pharmaceutical Products, 110 Penn. St. L. Rev. 41, 46 (2005).
Their use “can be a source of innovation, and in some settings may represent the standard
of care.” Donna T. Chen et al., U.S. Physician Knowledge of the FDA-Approved
Indications and Evidence Base for Commonly Prescribed Drugs: Results of a National
Survey, 18 Pharmacoepidemiology & Drug Safety 1094, 1094 (2009) (footnotes omitted).
Regarding off-label prescriptions, the FDA has even acknowledged that “[g]ood medical
practice and the best interests of the patient require that physicians use legally available
drugs, biologics and devices according to their best knowledge and judgment.” Food &
Drug Admin., “Off-Label” and Investigational Use of Marketed Drugs, Biologics, and
Medical Devices (Jan. 1998), http://tinyurl.com/4etfhhpy.
Generally, the FDA cannot prohibit, direct, or advise against the off-label uses of
approved human drugs. Nothing in the FDCA gives the agency that authority. Ass’n of Am.
Physicians & Surgeons (“AAPS”) v. FDA, 13 F.4th 531, 534 (6th Cir. 2021) (“Although
the [FDCA] regulates a manufacturer’s distribution of drugs, it does not go further by
regulating a doctor’s practice of medicine. . . . It instead leaves the regulation of doctors to
the states.”); Judge Rotenberg Educ. Ctr., Inc. v. FDA, 3 F.4th 390, 400 (D.C. Cir. 2021)
(“Choosing what treatments are or are not appropriate for a particular condition is at the
heart of the practice of medicine.”). When Congress has authorized the FDA to limit
particular uses of an approved drug, Congress has done so explicitly. E.g., 21 U.S.C.
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§ 333(e) (restricting off-label use of “human growth hormone”). It is undisputed that
Congress has not done so here.
The FDA thus cannot take actions, including pressure campaigns and jawboning,
that “interfere” with “the practice of medicine, which is the exclusive realm of individual
states.” Planned Parenthood Cincinnati Region v. Taft, 444 F.3d 502, 505 (6th Cir. 2006);
see also, e.g., Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350 (2001) (“[T]he
FDA is charged with the difficult task of regulating the marketing and distribution of
medical devices without intruding upon decisions statutorily committed to the discretion
of health care professionals.”); AAPS, 13 F.4th at 534; Judge Rotenberg, 3 F.4th at 400.
As a result, once a drug has been approved by the FDA for human use, appropriate
healthcare professionals can prescribe or dispense the drug off-label when done for a
medical purpose within the scope of a doctor-patient relationship. See, e.g., In re Schering
Plough Corp. Intron/Temodar Consumer Class Action, 678 F.3d 235, 240 (3d Cir. 2012)
(“Because the FDCA does not regulate the practice of medicine, physicians may lawfully
prescribe drugs for off-label uses.”); Planned Parenthood Cincinnati Region, 444 F.3d at
505 (“Absent state regulation, once a drug has been approved by the FDA, doctors may
prescribe it for indications and in dosages other than those expressly approved by the
FDA. . . . Off-label use does not violate federal law or FDA regulations[.]”); Wash. Legal
Found. v. Henney, 202 F.3d 331, 333 (D.C. Cir. 2000) (“A physician may prescribe a legal
drug to serve any purpose that he or she deems appropriate, regardless of whether the drug
has been approved for that use by the FDA.”). The FDA cannot wade into the debate over
whether certain drugs can or should be used for specific purposes. Its role is a gatekeeper,
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not regulator, of the practice of medicine.
II.
FDA Campaign Against Ivermectin
On March 5, 2021, the FDA published “Why You Should Not Use Ivermectin to
Treat or Prevent COVID-19” on its website. Ex.19. The title of the publication states an
official FDA position that ivermectin should not be used for the treatment or prevention of
COVID-19. Id. Nowhere did this publication acknowledge that doctors can lawfully
prescribe ivermectin for that use, instead stating only 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 2. This incorrectly conveyed that ivermectin can only be prescribed and
used for FDA-approved purposes. Ironically, the FDA took this action notwithstanding an
admission that the agency “ha[d] not reviewed data to support use of ivermectin in COVID-
19 patients to treat or to prevent COVID-19.” Id.
The FDA later amended “Why You Should Not Use Ivermectin to Treat or Prevent
COVID-19” to state 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,” removing “for an FDA-approved use.” Ex.1, at 2. But that “trailing qualifier
does not lessen the opening instruction’s imperative character.” Apter, 80 F.4th at 589.
The FDA has also published an Ivermectin FAQ, entitled “COVID-19 and
Ivermectin Intended for Animals.” Ex.2. The Ivermectin FAQ begins with, “Q: Should I
take ivermectin to prevent or treat COVID-19?” and flatly answers that question, “A: No.”
Id. It continues that “[w]hile there are approved uses for ivermectin in people and animals,
it is not approved for the prevention or treatment of COVID-19. You should not take any
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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. None of this changes the FDA’s
unequivocal direction that ivermectin should not be used for COVID-19 and the clear
message that doctors should not (and possibly cannot) prescribe it for that use.
The FDA similarly maintains another COVID-19 FAQ that asks, “Q: Should I take
ivermectin to prevent or treat COVID-19?” and answers that question, “A: No.” Ex.3. The
COVID-19 FAQ continues that “[w]hile there are approved uses for ivermectin in people
and animals, it is not approved for the prevention or treatment of COVID-19,” followed by
a link to “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.” Id.
On August 21, 2021, the FDA tweeted, “You are not a horse. You are not a cow.
Seriously, y’all. Stop it.” Ex.4. The tweet displayed the title of FDA’s “Why You Should
Not Use Ivermectin to Treat or Prevent COVID-19” and linked to that publication. The
FDA posted the same image and message to LinkedIn and Facebook. Ex.5. All three
publications unequivocally direct the public not to use ivermectin for COVID-19. The
August 21, 2021 tweet was viewed by over 24 million people in two days—not including
the millions more who saw the tweet reproduced on other platforms or in mainstream
media—quickly becoming the most viewed tweet in FDA history. Ex.20.
Also on August 21, 2021, the FDA posted to Instagram a picture 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. The post misleadingly depicts ivermectin as a horse medication not
approved for human use and unequivocally directs the public not to use it for COVID-19.
The FDA celebrated its successful messaging as part of a “new engagement
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strategy” to influence the public. Ex.20. Erica Jefferson, Associate Commissioner for
External Affairs, explained that the FDA saw this as an “opportunity to remind the public”
of the FDA’s position on ivermectin, creating “a unique viral moment” where the FDA
could “reach the ‘everyday’ American . . . in a time of incredible misinformation.” Ex.21,
at 5–6. She similarly expressed her satisfaction about the number of people who viewed
the tweet: “The numbers are racking up and I laughed out loud.” Id. at 4.
The FDA went further still, sending a letter to the Federation of State Medical
Boards and National Association of Boards of Pharmacy to further influence medical
practice. It warned against using ivermectin for COVID-19 and included a link to “Why
You Should Not Use Ivermectin to Treat or Prevent COVID-19.” Ex.22.
The FDA’s “new engagement strategy” resulted in its foreseeable and intended
effect of interfering with the use of ivermectin to treat COVID-19. The FDA was delighted
to see media outlets parrot its message, referring to ivermectin as “horse dewormer” and
“horse paste.” Ex.21. As intended, others pushed the narrative with headlines like “Say
‘Neigh’ to Ivermectin” and “You Are Not a Horse.” Id.
Individual healthcare professionals even joined the refrain, citing the FDA and
publicly labeling those who prescribe ivermectin, including Plaintiffs, as quack doctors
practicing veterinary medicine on humans. See Exs.23–24.
Again, following the FDA’s lead, the American Medical Association (“AMA”),
American Pharmacists Association (“APhA”), and American Society of Health-System
Pharmacists (“ASHP”) quickly issued a joint statement “strongly oppos[ing] the ordering,
prescribing, or dispensing of ivermectin to prevent or treat COVID-19 outside of a clinical
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trial,” and pointed to the FDA’s “Why You Should Not Use Ivermectin to Treat or Prevent
COVID-19” as part of their justification. Ex.25. This joint statement was issued just 11
days after the FDA’s “Stop it” tweet. State pharmacy boards likewise issued statements on
dispensing ivermectin, which directly linked to the FDA’s “Why You Should Not Use
Ivermectin to Treat or Prevent COVID-19.” See, e.g., Ex.26. And hospitals also started
relying on the FDA’s “Why You Should Not Use Ivermectin to Treat or Prevent COVID-
19” and August 21, 2021, tweet—even reproducing the tweet in court filings—to justify
prohibiting the use of ivermectin to treat patients, regardless of whether the drug was
prescribed by a doctor. Ex.12, at 5; Ex.27, at 8–9, 21.
Even courts have relied on the FDA’s actions to decide cases involving ivermectin,
including as persuasive evidence about the effectiveness of the drug and appropriate
standard of care. See, e.g., Shoemaker v. UPMC Pinnacle Hosps., 283 A.3d 885, 895 (Pa.
2022); Smith v. West Chester Hosp., LLC, 2021 WL 4129083, at *1, 2, 4 (Ohio Ct. Com.
Pl. Sept. 6, 2021); DeMarco v. Christiana Care Health Servs., Inc., 263 A.3d 423, 435
(Del. Ch. 2021); Abbinanti v. Presence Cent. & Suburb. Hosps. Network, 2021 IL App.
(2d) 210763, ¶ 10 (2021); see also Gahl v. Aurora Health Care, Inc., 977 N.W.2d 756,
762–63 (Wis. Ct. App. 2022). Indeed, courts have looked to the FDA’s “Why You Should
Not Use Ivermectin to Treat or Prevent COVID-19” to determine “deviation from accepted
medical practices,” which “is an essential element of medical malpractice.” D.J.C. for
D.A.C. v. Staten Island Univ. Hosp.-Northwell Health, 157 N.Y.S.3d 667, 673 (2021).
“All told, the [Twitter posts]—and particularly [“Why You Should Not Use
Ivermectin to Treat or Prevent COVID-19”]—saw citations in newspapers, magazines,
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digital media outlets, medical and professional advisories, legal complaints, and judicial
opinions across the Nation.” Apter, 80 F.4th at 585.
On April 26, 2022, the FDA continued its relentless campaign, again pushing its
narrative that ivermectin is only for animal use and advising the public not to use it for
COVID-19. The tweet read, “Hold your horses, y’all. Ivermectin may be trending, but it
still isn’t authorized or approved to treat COVID-19.” Ex.7. The tweet again displays the
title of “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19” and links to
that publication. Id.3
III.
Procedural History
Plaintiffs filed suit in the Southern District of Texas on June 2, 2022, and amended
their complaint on August 8, 2022, alleging the FDA acted ultra vires and violated the
APA. ECF.Nos.1, 12. On August 26, 2022, the FDA filed a motion to dismiss under
Federal Rules of Civil Procedure 12(b)(1) and (6), arguing that Plaintiffs lack constitutional
standing to pursue their claims and invoking sovereign immunity. ECF.No.25. This Court

3 The FDA is wrong to frame these actions as only a concerned response to “multiple reports
of patients who required medical attention, including for hospitalization, after self-
medicating with ivermectin products intended for animals.” R-MTD.1. First, the article
“Why You Should Not Use Ivermectin to Treat or Prevent COVID-19” was initially
published on March 5, 2021, predating the reports about use of animal ivermectin in August
2021. Second, the FDA was still using the “horse paste” trope as late as April 26, 2022,
long after any concern would have abated from handful of earlier reports about animal-
ivermectin use. Third, internal correspondence from the FDA confirms the agency’s goal
was to use the situation as an “opportunity to remind the public of [its] own warnings for
ivermectin,” Ex.21, at 5, and try a “new engagement strategy,” Ex.20, which explains its
dramatic response to a mere four people using animal ivermectin in a country of over 330
million people, see Ex.21, at 1–3. And fourth, the FDA’s statements repeatedly referenced
ivermectin—not “animal ivermectin.”
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dismissed the claims as barred by sovereign immunity. ECF.No.45.
The Fifth Circuit reversed as to Plaintiffs’ ultra vires claim, holding that the FDA
“has not offered even a ‘colorable basis’” for its actions, and “[e]ven tweet-sized doses of
personalized medical advice are beyond FDA’s statutory authority.” Apter, 80 F.4th at 588,
595. The Court explained that the “FDA is not a physician. It has authority to inform,
announce, and apprise—but not to endorse, denounce, or advise.” Id. at 595. Plaintiffs have
therefore “plausibly alleged that FDA’s [actions] fell on the wrong side of the line between
telling about and telling to,” and thus Plaintiffs can “assert their ultra vires claims.” Id.
On remand, the FDA asked to file a renewed motion to dismiss for lack of standing,
citing a need to “account for the Fifth Circuit’s opinion, which . . . affects the standing
analysis.” ECF.No.54, at 2.4
STANDARD OF REVIEW
“When standing is challenged on the basis of the pleadings,” courts “must accept as
true all material allegations of the complaint and construe the complaint in favor of the
complaining party.” AAPS v. Tex. Med. Bd., 627 F.3d 547, 550 (5th Cir. 2010) (cleaned
up). If the Defendant raises a factual dispute and “submits affidavits, testimony, or other
evidentiary materials,” the Plaintiff then “must prove the existence of subject-matter
jurisdiction by a preponderance of the evidence” and may “submit facts through some
evidentiary method to sustain his burden of proof.” Superior MRI Servs., Inc. v. All.

4 The FDA then used that opportunity to file over 350 pages of new material, expand its
arguments, and raise factual disputes, none of which was affected by the Fifth Circuit’s
decision.
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Healthcare Servs., Inc., 778 F.3d 502, 504 (5th Cir. 2015) (cleaned up). But Plaintiffs “are
entitled to rely on the allegations in the Pleading if the evidence proffered by the defendant
is immaterial because it does not contradict plausible allegations that are themselves
sufficient to show standing.” Carter v. HealthPort Techs., LLC, 822 F.3d 47, 57 (2d Cir.
2016); see Lane v. Halliburton, 529 F.3d 548, 557 (5th Cir. 2008) (“[T]he court may find
a plausible set of facts by considering any of the following: (1) the complaint alone; (2) the
complaint supplemented by the undisputed facts evidenced in the record; or (3) the
complaint supplemented by undisputed facts plus the court’s resolution of disputed facts.”
(cleaned up)).
SUMMARY OF THE ARGUMENT
Plaintiffs satisfy all three elements of standing. The undisputed allegations show
that the Plaintiffs have suffered interference with their practice of medicine and the doctor-
patient relationship, economic harm, reputational harm, and increased exposure to
malpractice liability, all of which can be traced back to the FDA’s campaign against
ivermectin and would be remedied by equitable relief. Moreover, the record evidence
shows it is more likely than not that Plaintiffs’ disciplinary proceedings and forced
resignations are traceable to the FDA’s actions.
ARGUMENT
To establish standing to sue, as required by Article III of the U.S. Constitution,
Plaintiffs must show (1) “a concrete and particularized injury,” (2) “that is fairly traceable
to the challenged conduct,” and (3) “is likely to be redressed by a favorable judicial
decision.” Hollingsworth v. Perry, 570 U.S. 693, 704 (2013). Standing is not “a mechanical
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exercise” and “incorporates concepts concededly not susceptible of precise definition.”
Allen v. Wright, 468 U.S. 737, 751 (1984). “[A]t least one plaintiff must have standing to
sue.” Dep’t of Com., 139 S. Ct. at 2565.
I.
Plaintiffs Have Been Injured
Plaintiffs have demonstrated numerous injuries, any one of which is sufficient to
establish standing. The injury “need not measure more than an identifiable trifle.” OCA-
Greater Hous. v. Texas, 867 F.3d 604, 612 (5th Cir. 2017) (cleaned up).
A.
Interference in the Practice of Medicine
Plaintiffs have suffered injury to their practice of medicine. As accomplished
physicians with many decades of experience, Plaintiffs have interests in practicing
medicine according to their best reasoned judgment and in maintaining relationships of
trust and confidence with their patients.
The doctor-patient relationship is privileged at law. See, e.g., Tex. R. Evid. 509
(“Physician-Patient Privilege”). “[I]t is the physician’s role to consider multiple factors,
including a drug’s FDA-approval status, to determine the best course of action for her
patient,” and the FDA injures that role when it interferes and offers medical advice. United
States v. Caronia, 703 F.3d 149, 167 (2nd Cir. 2012) (citing Buckman, 531 U.S. at 350; 21
U.S.C. § 396); cf. Trump v. IRAP, 582 U.S. 571, 583 (2017) (interference with “a bona fide
relationship” results in “concrete hardship”). If recreational and aesthetic injury are
sufficient to establish standing, see Friends of the Earth, Inc. v. Laidlaw Env’t. Servs.
(TOC), Inc., 528 U.S. 167, 183 (2000), then interference with a vocation and the doctor-
patient relationship qualifies.
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Congress is also “well positioned to identify intangible harms that meet minimum
Article III requirements.” Spokeo, Inc. v. Robins, 578 U.S. 330, 341 (2016). Congress has
recognized that doctors have an interest in being free from interference in their practice of
medicine—especially from the FDA. See 21 U.S.C. § 396.5
The FDA argues this interference is all too “vague and conclusory” to support an
injury, R-MTD.24, but Plaintiffs have pointed to specific harms resulting from that
interference. Pharmacists have refused to fill ivermectin prescriptions from Dr. Apter for
his patients, citing the FDA’s actions regarding using the drug to treat COVID-19, which
delays his ability to treat patients when early treatment is vital. Am.Compl. ¶¶ 14–16. In
his extensive experience as a doctor, patients believe that the FDA’s pronouncements are
authoritative and want care that complies with such pronouncements. Id. ¶ 17. Insurance
companies are also refusing to pay for ivermectin to treat COVID-19, and the only
observable bases for this are pronouncements and pressure from the FDA. Id.

5 Numerous courts have recognized that 21 U.S.C. § 396 is at least indicative that doctors
have an interest in practicing medicine free from interference from the FDA, including the
prescription of off-label drugs. See, e.g., U.S. ex rel. King v. Solvay Pharms., Inc., 871 F.3d
318, 328 (5th Cir. 2017); Med. Mut. of Ohio v. AbbVie Inc., 784 F. App’x 457, 457 (7th
Cir. 2019); Markland v. Insys Therapeutics, Inc., 758 F. App’x 777, 780 (11th Cir. 2018);
U.S. ex rel. Polansky v. Pfizer, Inc., 822 F.3d 613, 615 (2d Cir. 2016); U.S. ex rel. Nathan
v. Takeda Pharms. N. Am., Inc., 707 F.3d 451, 454 n.2 (4th Cir. 2013); United States v.
Caronia, 703 F.3d 149, 167 (2d Cir. 2012); United States v. Muoghalu, 662 F.3d 908, 911
(7th Cir. 2011); In re Gilead Sci. Sec. Litig., 536 F.3d 1049, 1051 & n.2 (9th Cir. 2008).
This Court previously held that that § 396’s application to drugs is not sufficiently clear to
support “enlarg[ing] the scope of the ultra-vires-act exception to sovereign immunity,” but
acknowledged that “[i]n some circumstances, [that] may be a comfortable inference for the
court to make.” Apter v. Dep’t of Health & Hum. Servs., 644 F.Supp.3d 361, 369 (2022).
The standing inquiry, which asks only whether a plaintiff has a “personal stake in the case,”
TransUnion LLC v. Ramirez, 594 U.S. 413, 423 (2021) (cleaned up), is not subject to the
clear statement rules that typically accompany sovereign immunity.
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Pharmacists have similarly refused to fill Dr. Bowden’s prescriptions for
ivermectin, citing FDA directives not to use the drug for COVID-19. Id. ¶ 27. Her patients
have also delayed seeking treatment for COVID-19, or been hesitant to accept her
recommendations, because the FDA says not to use ivermectin for that purpose. Id. ¶ 29.
The FDA repeatedly insists that because Plaintiffs have continued to prescribe
ivermectin, they have not been harmed. R-MTD.2, 17, 23–24, 28–29. But Plaintiffs’ ability
to prescribe ivermectin in some cases does not negate the many times the FDA’s actions
have interfered—and will continue to interfere—in others. See, e.g., Am.Compl. ¶¶ 14–17,
25, 27–29, 40–43. It also does not account for the now-countless hours Plaintiffs have spent
on the phone with pharmacists, or looking for new pharmacists, to get their prescriptions
filled—time Plaintiffs could have spent with patients, as discussed below. Ex.29.
The FDA also argues that Plaintiffs cannot assert harm to third parties like their
patients or outside pharmacists. R-MTD.24–26. But Plaintiffs do not need to rely on third-
party harms because they suffered injury to their own practice of medicine due to their
inhibited ability to treat patients, including prescribing and administering ivermectin. The
Fifth Circuit has already concluded that the FDA exceeded its authority and crossed the
line into interfering with the practice of medicine. Apter, 80 F.4th at 588–89, 595.
But the FDA is correct that its actions also harmed Plaintiffs’ patients. Citing FDA
directives, pharmacists refused to fill ivermectin prescriptions, preventing patients from
being timely treated. Am.Compl. ¶¶ 27–28. And patients have delayed seeking effective
COVID-19 care based on the FDA’s statements, complicating treatment when early
intervention is vital. Id. ¶ 15. Those patients, too, have an interest in ensuring the doctor-
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patient relationship remains free from the FDA’s meddling, and Plaintiffs can assert those
interests under the traditional test for third-party standing. See Singleton v. Wulff, 428 U.S.
106, 114–115 (1976). “The closeness of the relationship” between Plaintiff physicians and
their patients is obvious because a patient “cannot easily secure” ivermectin treatment
“without the aid of a physician.” Id. at 117. And patients seeking such treatment face
“several obstacles” to asserting their own rights, including “imminent mootness”—a
patient will no longer need ivermectin (which is most effective in the early stages of
infection) before the suit completes—and “a desire to protect the . . . privacy” of the
patient’s wish for a treatment that has been widely disparaged. Id.
In arguing otherwise, the FDA ignores the unique considerations inherent in the
practice of medicine that the Supreme Court has held can allow “providers to invoke the
rights of their actual or potential patients,” June Med. Servs. L.L.C. v. Russo, 140 S. Ct.
2103, 2118 (2020), especially regarding treatments that have been heavily stigmatized, in
this case by the FDA as being animal-only drug forbidden for human use. The FDA blinks
reality by claiming there is no reason those patients would be “unable or unwilling to bring
claims on their own behalves.” R-MTD.25 (quoting AIDS Healthcare Found., Inc. v. City
of Baton Rouge, 2017 WL 2899689, at *4 (M.D. La. July 7, 2017)).
Plaintiffs’ concrete injuries are confirmed by TransUnion LLC v. Ramirez, where
the Supreme Court explained that “a ‘close relationship’ to a harm traditionally recognized
as providing a basis for a lawsuit in American courts,” or a “historical or common-law
analogue for their asserted injury,” is sufficient for purposes of standing. 594 U.S. 413,
417, 424 (2021) (quoting Spokeo, 578 U.S. at 340–41). An “exact duplicate” is not
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required, thus allowing for “[v]arious intangible harms” and “‘de facto injuries that were
previously inadequate in law’” and “‘may be difficult to prove or measure.’” Id. at 424–
25, 437 (quoting Spokeo, 578 U.S. at 341) (emphasis removed)).
Tortious interference with the doctor-patient relationship is a cause of action at
common law. See, e.g., Phoebe Carter, Liability for Interference with Physician-Patient
Relationship, 87 A.L.R. 4th 845 (1991) (collecting cases); Regents of the Univ. of Cal. v.
Aisen, 2016 WL 1428072, at *6 (S.D. Cal. Apr. 12, 2016) (denying motion to dismiss claim
for “tortious interference with the doctor-patient relations”); Garcia v. Home Depot U.S.A.,
Inc., 1999 WL 362787, at *6 (N.D. Tex. June 2, 1999); Moore & Assocs. v. Metro. Life
Ins. Co., 604 S.W. 2d 487 (Tex. Civ. App. 1980). Generally, establishing injury for such
claims requires showing that acts of the defendant disrupted an existing doctor-patient
relationship, causing the plaintiff economic harm. See, e.g., Aisen, 2016 WL 1428072, at
*6–7. The injury experienced by Plaintiffs is not required to be “an exact duplicate,” but it
is analogous. TransUnion, 594 U.S. at 424–25, 437. As explained above, the FDA’s actions
interfered in Plaintiffs’ relationships with their patients, causing patients to delay seeking
treatment from Plaintiffs for COVID-19 and to hesitate to follow Plaintiffs’
recommendations. Am.Compl. ¶¶ 28, 29. Plaintiffs were also required to divert hours that
could have been spent with patients to respond to pharmacy inquiries and look for new
pharmacists to fill prescriptions, causing economic harm, as discussed below. Ex.29. This
is more than sufficient to establish injury under TransUnion.
B. Economic Harm
Plaintiffs have suffered economic harm. As the Fifth Circuit explained in Alliance
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for Hippocratic Medicine v. FDA, Plaintiffs “sustain a concrete injury when they are forced
to divert time and resources away from their regular” practice. 78 F.4th 210, 235–36 (5th
Cir. 2023). Because pharmacists, citing the FDA’s directives, have refused to fill Dr.
Bowden’s prescriptions for ivermectin, Dr. Bowden has been forced to spend countless
hours on the phone with pharmacists and searching for alternative pharmacies to dispense
the medication for her patients. Ex.29. She continues to have that experience multiple times
each month. Id. Those hours could be devoted to her regular practice, including seeing
additional patients. This diversion results in “economic harm . . . a quintessential Article
III injury.” Alliance, 78 F.4th at 235.
C. Increased Exposure to Malpractice Liability
The Fifth Circuit in Alliance for Hippocratic Medicine also held that plaintiffs
“sustain a concrete injury” when a defendant’s actions “expose them to greater
[malpractice] liability and increased insurance costs.” 78 F.4th at 236. The FDA’s unlawful
campaign exposes Plaintiffs to increased liability for their continued prescribing of
ivermectin because courts have relied on the FDA’s anti-ivermectin statements to
determine “deviation from accepted medical practices,” which “is an essential element of
medical malpractice.” Staten Island Univ. Hosp., 157 N.Y.S.3d at 673; Am.Compl. ¶ 110.
D. Reputational Harm
Plaintiffs have suffered reputational harm. Under TransUnion, among the “[v]arious
intangible harms” that suffice to establish concrete injury is “reputational harm,” which
“bears a ‘close relationship’ to . . . the tort of defamation.” 594 U.S. at 417, 425, 432. It
is beyond dispute that Plaintiffs have suffered reputational harm. Dr. Bowden in particular
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has been subject to vicious reputational attacks and endured significant abuse online,
examples of which are included in the Amended Complaint. Exs.23, 24.
In a notable example, a pharmacist using the TikTok handle “rx0rcist,” with
approximately 1 million followers on that platform, displayed the FDA’s “Why You
Should Not Use Ivermectin to Treat or Prevent COVID-19” and berated Dr. Bowden for
using ivermectin because “the FDA said nope.” Ex.23. Others have publicly labeled
healthcare professionals who prescribe ivermectin as quack doctors practicing veterinary
medicine on humans, specifically citing and showing a picture of Dr. Bowden. Ex.24. The
FDA cannot divorce its medical recommendations and directives from the packing and
“new engagement strategy” it used, Ex.20, which disparaged doctors who might be inclined
to prescribe ivermectin to drive home the FDA’s message that use of the drug for COVID-
19 was inappropriate, if not forbidden.
E. Disciplinary Proceedings and Forced Resignations
Plaintiffs have been subject to disciplinary proceedings and forced to resign their
various positions. Dr. Apter was referred by the Iowa Board of Medicine to the Washington
Medical Commission and Arizona Medical Board because he prescribed ivermectin to treat
COVID-19, and the referrals include copies of the FDA’s publications directing against
that use. Am.Compl. ¶ 18. Dr. Bowden was derided by Houston Methodist Hospital and
forced to resign her privileges for prescribing ivermectin. Id. ¶ 21. And Dr. Marik was
forced to resign from his positions at Eastern Virginia Medical School (“EVMS”) and
Sentara Norfolk General Hospital—even after developing EVMS’s COVID-19 treatment
protocol—for continuing to promote ivermectin to treat COVID-19 after the FDA’s
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attempts to stop use of those drugs for that purpose. Id. ¶¶ 38–39, 42.
The FDA argues that being subject to disciplinary proceedings is not a cognizable
harm. R-MTD.18. But where “a plaintiff has engaged in a course of [protected] conduct
and the state has instructed him to stop or face disciplinary action, . . . a plaintiff has
adequately alleged a concrete and imminent harm sufficient to meet the ‘injury in fact’
requirement.” Kiser v. Reitz, 765 F.3d 601, 608 (6th Cir. 2014). Dr. Apter may not be
asserting a due process claim, but that says nothing about whether he’s been injured in his
time, money, and personal well-being because of the investigation.
The FDA now raises a factual challenge to the circumstances of Dr. Apter’s
disciplinary proceedings, as well as Dr. Bowen and Dr. Marik resignations. R-MTD.20–
23. The FDA argues that “the referrals regarding Apter are not fairly traceable to the
[FDA’s] [s]tatements.” R-MTD.21. But the FDA’s new evidence shows otherwise. The
complaint to the Washington Medical Commission was from a pharmacist charging
“[i]nappropriate prescribing” because Dr. Apter wouldn’t provide a “valid [non-COVID]
medical reason” for the ivermectin prescription. R-MTD.Ex.B, at 3. The complaint cites
the FDA’s “recommendations” as the reason for the “increase[d] scrutiny.” Id. And the
referrals to the Washington Medical Commission and Arizona Medical Boards include
copies of the FDA’s directives. Ex.8.
The FDA also argues that Dr. Bowden and Dr. Marik “voluntarily resigned” from
their hospital positions, so they weren’t injured. R-MTD.2, 10–11, 14, 18, 21–23. That
ignores the obvious fact that both Dr. Bowden and Dr. Marik resigned under duress. See
Exs. 9, 10. Resignation under duress is a cognizable injury akin to termination. See, e.g.,
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Green v. Brennan, 578 U.S. 547, 555 (2016) (discussing “constructive discharge”).6 The
undeniable timing of these investigations and forced resignations immediately following
when the FDA began its pressure campaign against ivermectin in earnest highlights the
predominant role that issue played in the disciplinary actions.
II.
Plaintiffs’ Injuries Are Fairly Traceable to the FDA
“Proximate causation is not a requirement of Article III standing, which requires
only that the plaintiff’s injury be fairly traceable to the defendant’s conduct.” Lexmark
Int’l, Inc. v. Static Control Components, Inc., 572 U.S. 118, 134 n.6 (2014). Traceability
“‘requires no more than de facto causality,’” Dep’t of Com., 139 S. Ct. at 2566 (quoting
Block v. Meese, 793 F.2d 1303, 1309 (D.C. Cir. 1986)).
An injury is also “fairly traceable” if it “relies . . . on the predictable effect of
Government action on the decisions of third parties,” even when those decisions are
illogical or “unlawful.” Dep’t of Com., 139 S. Ct. at 2565–66; see Tozzi v. HHS, 271 F.3d
301, 308–09 (D.C. Cir. 2001); Cmty. For Creative Non–Violence v. Pierce, 814 F.2d 663,
669 (D.C. Cir. 1987) (finding traceability if government action played a “substantial factor
motivating the third parties’ actions”). “[P]redictability does not require certainty.”
Missouri v. Biden, 83 F.4th 350, 371 (5th Cir. 2023).
The FDA is the common thread through all of Plaintiffs’ injuries, which began only
after the FDA embarked on its campaign to stop the use of ivermectin for COVID-19 and

6 Dr. Marik’s public reflection that resigning “was not an easy decision to make, but [he]
felt it was time to focus [his] attention and energy to other interests,” R-MTD.Ex.O, says
nothing about whether his resignation was free from duress. See R-MTD.22.
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which often involve explicit invocation of the FDA’s directives and recommendations. The
agency has consistently asserted itself as the authoritative voice on drugs in the United
States, and now leverages its influence in an admittedly novel way to hang Damocles’
sword over healthcare professionals and pressure both professional and patient judgment
about the use of ivermectin. See Ex.20 (FDA celebrating this “new engagement strategy”).
The FDA has already conceded that its actions “influenced the thinking” of third
parties about the “use of ivermectin to prevent or treat COVID-19,” and those third parties
then “allegedly took actions that caused Plaintiffs’ injuries.” ECF.No.25, at 15. But the
FDA expresses disbelief that this simple chain of events was predictable.
Common sense dictates that there was no reason for the FDA’s actions to stop the
use of ivermectin except to cause such reactions. The FDA told the entire country to “Stop
it” and “Stop it with the #Ivermectin,” with the tweet being the most-viewed in FDA
history, so the FDA cannot now insist that it is not even plausible that patients, pharmacists,
professional groups, medical boards, and hospitals may have reacted by doing just that.
The FDA even sent a letter about ivermectin to the Federation of State Medical
Boards and the National Association of Boards of Pharmacy linking to “Why You Should
Not Use Ivermectin to Treat or Prevent COVID-19.” Ex.22. Combined with the FDA’s
public pressure campaign telling people to “Stop it with the #Ivermectin,” it was
predictable and intended that those regulatory boards—who obviously want to stay in the
good graces of a federal regulatory body—would react by focusing their attention on
doctors seeking to use ivermectin.
And even if any of these reactions weren’t immediately predictable, they definitely
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were shortly after the FDA began its campaign. But the FDA not only celebrated its
success, Ex.20, it has consistently maintained “Why You Should Not Use Ivermectin to
Treat or Prevent COVID-19,” at least one of its FAQs, and its social media posts on official
FDA platforms, and it even doubled down on April 26, 2022, Ex.7.
The FDA asserts that all Plaintiffs’ injuries were caused by independent third parties
because, quoting Bennett v. Spear, 520 U.S. 154, 169 (1997), the FDA’s actions lacked
“‘determinative or coercive effect.’” R-MTD.18–19. This misdirection attempts to import
the standard for final agency action under the APA. Id. The Fifth Circuit has already
rejected the FDA’s attempt to import the requirements for final agency action into the
question of sovereign immunity. See Apter, 80 F.4th at 591. All that matters here is whether
the injury is “fairly traceable” to the FDA.7
The undisputed allegations and evidence in the record shows that Plaintiffs’ injuries
are “fairly traceable” to the FDA’s directives against the use of ivermectin for COVID-19.
Pharmacists cited the FDA’s “recommendations” in refusing to fill ivermectin for Dr.
Apter’s and Dr. Bowden’s patients. Am.Compl. ¶¶ 15, 27–28; Exs. 8, 9; see also R-
MTD.Ex.B, at 3 (pharmacy flagging, and declining to fill, ivermectin prescription based
on “recommendations from . . . FDA”); R-MTD.Ex.C, at 3-4 (pharmacist directed to
“scrutinize the [ivermectin] prescription because of recommendations from . . . the FDA”).
As a result, Dr. Apter and Dr. Bowden spent countless hours justifying their prescriptions

7 The FDA’s citation to Physicians for Integrity in Medical Research, Inc. v. Ostroff, 670
F. App’x 450, 451 (9th Cir. 2016) (mem.), is unpersuasive. That out-of-circuit, unpublished
opinion does not address ultra vires FDA actions intentionally designed to “engag[e]” the
public, Ex.20, give medical advice, and sway private and professional behavior.
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and seeking pharmacies to fill them. Ex.29; see also R-MTD.Ex.B, at 4 (Dr. Apter
responding to pharmacy call); R-MTD.Ex.C, at 3 (same). And Plaintiffs have been subject
to vicious reputational attacks and online abuse, which have referenced the FDA’s
statements and tweets for support because “The FDA said nope.” Exs.23, 24.
That medical boards and hospitals have cited additional justification for their
actions, R-MTD.8–13, 20–23, does not break their traceability to the FDA. See Rieves v.
Town of Smyrna, 67 F.4th 856, 862 (6th Cir. 2023) (“[T]he plaintiff need not prove that the
defendant was the sole cause of his injury[.]”); Sierra Club v. Dep’t of Interior, 899 F.3d
260, 284 (4th Cir. 2018) (similar). To the contrary, those actions explicitly invoke the FDA,
most often “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.” As
explained above, the complaints and referrals that instigated the proceedings explicitly
referenced the FDA’s recommendations and directives. Dr. Bowden’s resignation was
spurred in part by public statements by hospital leadership that she was “spreading
‘dangerous’ misinformation” about COVID-19 treatments, i.e. ivermectin, R-MTD.Ex.L,
at 3–4, and the hospital had earlier made clear that its stance was based in part on the FDA’s
statements. Ex.30, Houston Methodist Hospital, 5 Reasons You Shouldn’t Take Ivermectin
for COVID-19 (Sept. 10, 2021), http://tinyurl.com/25mry88t (linking to “Why You Should
Not Use Ivermectin to Treat or Prevent COVID-19”). And Sentara Norfolk General
Hospital’s decision to prohibit the use of ivermectin for COVID-19, which precipitated Dr.
Marik’s resignation, Ex.10, was prompted not “‘primarily’ . . . [by] clinical trials” data, R-
MTD.22, but by the joint statement of the AMA, APhA, and ASHP, which itself relies on
“Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.” See R-MTD.Ex.N,
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at 135 (“When our team saw [the joint statement] . . . we felt it was our duty” to “stop
prescribing and using ivermectin[.]”). The FDA’s actions directly harmed Plaintiffs or
predictably set into motion the events that did.
The FDA excuses its actions because they “‘neither require nor forbid any action.’”
R-MTD.19 (quoting Summers v. Earth Island Inst., 555 U.S. 488, 493–94 (2009)). The
Fifth Circuit has already rejected this argument, holding that the FDA used “syntax that is
imperative rather than declaratory.” Apter, 80 F.4th at 588. Despite the FDA’s unceasing
attempts to characterize its actions as merely informational, the Fifth Circuit was clear that
the FDA used “imperative” language and went “beyond mere factual communication.”
Apter, 80 F.4th at 591.
The FDA claims that “[n]one 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.” R-MTD.5. The FDA similarly asserts that its directives only
“generally recommended to consumers . . . that they should not take ivermectin to prevent
or treat COVID-19.” R-MTD.19. This ignores that the FDA did in fact send a letter about
ivermectin to the Federation of State Medical Boards and the National Association of
Boards of Pharmacy, linking to “Why You Should Not Use Ivermectin to Treat or Prevent
COVID-19,” betraying the assertion it was only for consumers. Ex.22. The FDA also
ignores its public pressure campaign telling the public to “Stop it” and “Stop it with the
#Ivermectin.” The FDA directed its message to everyone, so it’s entirely foreseeable when
anyone listened. These arguments are also beside the point because Plaintiffs have been
injured in their ability to practice medicine and in their relationship with patients, who
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unquestionably are consumers to whom the FDA alleges its campaign was addressed.
The FDA also relies on myriad language buried in some of its documents 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.’” R-MTD.20. But that
statement was not included in the social media posts, for example, and in any event the
Fifth Circuit has already held that “the trailing qualifier does not lessen the opening
instruction’s imperative character.” Apter, 80 F.4th at 589. When such statements fall under
a title of “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19,” or follow
“Q: Should I take ivermectin to prevent or treat COVID-19? A: No,” they convey the
message that ivermectin should be taken as prescribed only when doctors prescribe the
drug for purposes other than COVID-19. Indeed, that was explicit in the first draft of the
publication, which told patients to follow ivermectin prescriptions only “for an FDA-
approved use.” Ex.19, at 2. Moreover, Defendants cannot justify an unlawful foray into the
practice of medicine with a few subsequent, ambiguous statements, especially when its
actions are viewed as a whole.
Further fatal to the FDA’s argument, traceability can also be established in
retrospect. Lujan v. Defs. of Wildlife, 504 U.S. 555, 562 (1992) (“[P]laintiffs [can] adduce
facts showing that [third-party] choices have been or will be made in such manner as to
produce causation and permit redressability of injury[.]” (emphasis added)). As explained
above, Pharmacists have expressly cited FDA directives in refusing to fill Dr. Bowden’s
prescriptions for ivermectin. Am.Compl. ¶ 27. Her patients have delayed seeking treatment
because the FDA says not to use ivermectin to treat COVID-19. Am.Compl. ¶ 29. And Dr.
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Apter is currently subject to state regulatory board proceedings, which were instigated in
reliance on the FDA’s statements at issue here. R-MTD.Ex.D.
Courts have also relied on the FDA’s actions, citing the FDA’s statements as
evidence about the effectiveness of ivermectin to treat COVID-19 and the appropriate
standard of care. See, e.g., Smith, 2021 WL 4129083, at *1, 2, 4; DeMarco, 263 A.3d at
435; Abbinanti, 2021 IL App (2d) 210763, ¶ 10. Indeed, courts have looked to the FDA’s
“Why You Should Not Use Ivermectin to Treat or Prevent COVID-19” to determine
“deviation from accepted medical practices,” which “is an essential element of medical
malpractice.” Staten Island Univ. Hosp., 157 N.Y.S.3d at 672–73. While the Fifth Circuit
held that the FDA did not impose a “legal standard,” Apter, 80 F.4th at 594, the FDA’s
actions have nonetheless increased Plaintiffs’ exposure to legal liability.
It is thus more than “fair” to conclude that Defendants’ statements on ivermectin are
“traceable” to the harm suffered by Plaintiffs. Indeed, leading healthcare professionals,
scientists, and researchers recognize that the FDA is interfering with the practice of
medicine vis-à-vis ivermectin. See Am.Compl. ¶¶ 111–14. For example, Peter A.
McCullough, M.D., MPH—a renowned epidemiologist—explained that “[t]he FDA put
official communications out through Twitter and through other social media, and major
media. And it said, ‘Ivermectin is only a horse dewormer. Don’t use a veterinary product
to treat COVID-19.’” Am.Compl. ¶ 112. He concluded, “So, there was a clear theme that
was going on. At least the obvious suppression from a regulatory . . . perspective.” Id.
Pierre Kory, M.D., MPA—a distinguished and highly published critical care specialist—
has made similar observations. See Am.Compl. ¶ 114.
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Members of Congress likewise recognize the FDA is illegally interfering with the
practice of medicine by “tak[ing] steps to curtail the use of potential early treatments,”
including through the FDA’s “mocking of ivermectin, conflating a widely-available human
drug that was the basis for Nobel prize winning research, with its veterinary version,” and
have “created a new industry standard that restricts doctors’ abilities to prescribe certain
off-label treatments for COVID-19.” Ex.28, at 2–3. The Members also cite “Why You
Should Not Use Ivermectin to Treat or Prevent COVID-19.” Id. at 3 n.11.
When the actions of third parties consistently cite to the same FDA directives,
Plaintiffs’ injuries do not turn on “guesswork as to how independent decisionmakers will
exercise their judgment.” Clapper v. Amnesty Int’l USA, 568 U.S. 398, 413 (2013). Rather,
the link is at least “fair,” if not undeniable. The FDA would have the Court believe that all
these other actions—which explicitly rely on the FDA—would have occurred even absent
the FDA’s directives and recommendations, but that is the implausible view.
III.
Plaintiffs’ Injuries Are Redressable
Plaintiffs “need only show that a favorable ruling could potentially lessen [their]
injury,” and they “need not definitively demonstrate that a victory would completely
remedy the harm.” Sanchez v. R.G.L., 761 F.3d 495, 506 (5th Cir. 2014) (cleaned up); see
also Friends of the Earth, 528 U.S. at 181 (plaintiff meets the redressability test if it is
“likely”—not certain—“that the injury will be redressed by a favorable decision”).
“Causal connection and redressability are two sides of the same coin.” Animal Legal
Def. Fund v. Veneman, 469 F.3d 826, 835 (9th Cir. 2006). Thus, because Plaintiffs harms
are fairly traceable to the FDA’s actions, redressability is presumed. The FDA would not
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have issued the challenged statements if it did not believe its actions would affect the use
of ivermectin for COVID-19. Having succeeded in its campaign, the FDA cannot now
disclaim that clearly intended effect, nor contend that vacating the challenged statements
would somehow be fruitless. The FDA’s actions have inhibited Plaintiffs’ ability to
practice medicine, and thus a favorable ruling would result in at least partial relief by
removing that justification for the inhibition and the source of the reputational sting.
Here, the judgment of healthcare professionals and other entities in the causal chain
of Plaintiffs’ injuries would be freed from this material interference. For decades,
healthcare professionals, hospitals, and state regulatory boards have supported (i.e., not
interfered with) off-label prescriptions and would likely revert toward that norm (which is
sufficient for redressability). Am.Compl. ¶¶ 61–66, 124. Patients also will no longer be
caught between the FDA’s pressure campaign and Plaintiffs’ advice, restoring the primacy
of the doctor-patient relationship. Am.Compl. ¶¶ 16, 24, 27.
The FDA argues that intervention by this Court “would not likely cause
sophisticated actors in the healthcare field” to change course, because of their “independent
scientific knowledge about the therapeutic risks and benefits of using ivermectin to prevent
or treat COVID-19.” R-MTD.2, 27. The FDA ignores that the third parties here repeatedly
point to the FDA. The FDA touts that the AMA, APhA, and ASHP take the same position,
but they too cite the FDA. Ex.25. The FDA’s deference to Merck, R-MTD.27–28, is
particularly unpersuasive because it presumes representations by a pharmaceutical
company (which was in the process of developing a competing drug) carry as much weight
as the FDA. Plaintiffs also allege interference with their doctor-patient relationships, and
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the FDA makes no argument that patients are sophisticated actors in the sense used here.
The Fifth Circuit has also held that redressability is satisfied where the “fear of
future prosecution may be alleviated” by a favorable ruling, especially where it could
“arguably” result in “third parties” “chang[ing] . . . the policy” that negatively affects
Plaintiffs. McClure v. Ashcroft, 335 F.3d 404, 411 (5th Cir. 2003). It seems implausible
that courts will continue to rely on the FDA’s advice to establish the standard of care if it
is declared unlawful and enjoined. Cf. Staten Island Univ. Hosp., 157 N.Y.S.3d at 673.
The FDA also argues that because the Fifth Circuit held the FDA’s statements have
no legal effect, Plaintiffs can obtain no other relief. R-MTD.29. But Plaintiffs seek other
equitable relief that would require the FDA either to take down its still-posted statements
or amend them. Am.Compl.43–44. If this Court issued a ruling requiring those additional
forms of relief, it would “potentially lessen” Plaintiffs’ injuries. Sanchez, 761 F.3d at 506.
In sum, the FDA dismisses any consequences of the requested relief as
“‘speculative.’” R-MTD.28. But decades of consistent medical practice, and observation
of the pervasive off-label prescription of drugs throughout medicine, establish a compelling
baseline that would be at least partially restored once the FDA ceases its unlawful
interference, and the potential of even partial relief is sufficient to withstand a motion to
dismiss. Id.
CONCLUSION
The Court should deny Defendants’ motion to dismiss.

Case 3:22-cv-00184 Document 61 Filed on 01/12/24 in TXSD Page 37 of 39

January 12, 2024
/s/ Jared M. Kelson
R. Trent McCotter
So. Dist. No. 3712529
Texas Bar No. 24134174
Michael Buschbacher (pro hac vice)
D.C. Bar No. 1048432
Jared M. Kelson (pro hac vice)
Attorney-In-Charge
D.C. Bar No. 241393

Laura B. Ruppalt

V.A. Bar No. 97202
Boyden Gray PLLC
801 17th St NW, Suite 350
Washington, DC 20006
(202) 706-5488
jkelson@boydengray.com

Case 3:22-cv-00184 Document 61 Filed on 01/12/24 in TXSD Page 38 of 39

CERTIFICATE OF WORD AND PAGE COUNTS

I hereby certify that the total number of words in this document, exclusive of those
sections designated for omission, is 8738 words, as registered by Microsoft Word. I further
certify that this document, exclusive of those sections designated for omission for word
limit purposes, is 30 pages. I further certify that this document is in size 13 Times New
Roman font.
/s/ Jared M. Kelson
Jared M. Kelson

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.
/s/ Jared M. Kelson
Jared M. Kelson

Case 3:22-cv-00184 Document 61 Filed on 01/12/24 in TXSD Page 39 of 39

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Plaintiffs' Opposition to Renewed Motion to Dismiss — Apter v. HHS (Jan. 12, 2024) (S.D. Tex.)

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