Court filing

Amicus curiae brief — Apter v. HHS

Filed September 29, 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	2022-09-29

U.S. District Court for the Southern District of Texas (Galveston Division) · No. 3:22-cv-00184 · Doc. 29-1 · 2022-09-29 · Docket on CourtListener

Full text

IN THE UNITED STATES DISTRICT COURT
FOR THE 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,
v.
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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Case No. 3:22-cv-184 (JVB)

AMICUS CURIAE BRIEF OF THE
ASSOCIATION OF AMERICAN PHYSICIANS AND SURGEONS

Andrew L. Schlafly
SD Texas Bar ID NJ04066
939 Old Chester Rd.
Far Hills, NJ 07931
Tel: 908-719-8608
Fax: 908-934-9207
Email: aschlafly@aol.com
Counsel for Amicus Curiae
Association of American Physicians and Surgeons
Case 3:22-cv-00184 Document 29-1 Filed on 09/29/22 in TXSD Page 1 of 16

TABLE OF CONTENTS

Table of Contents ................................................................................................................. ii
Table of Authorities ............................................................................................................ iii
Identity, Interest and Authority to File ............................................................................... 1
Summary of Argument ....................................................................................................... 2
Argument ............................................................................................................................ 3
I.
Off-Label Prescribing Is Necessary to Effective Medical Treatment,
and the FDA’s Interference Is Illegal ........................................................................ 3
II.
FDA’s Unjustified Overreach Has Propagated into Court Decisions
and State Medical Board Actions .............................................................................. 6
III.
Legal Standing Exists to Challenge Devastating, Unauthorized
Falsehoods by Government ....................................................................................... 9
Conclusion ........................................................................................................................ 12
Certificate of Word and Page Counts ............................................................................... 12
Certificate of Service ........................................................................................................ 12

Case 3:22-cv-00184 Document 29-1 Filed on 09/29/22 in TXSD Page 2 of 16

iii

TABLE OF AUTHORITIES

Cases
Pages

Ass’n of American Physicians & Surgeons v. Clinton,

997 F.2d 898 (D.C. Cir. 1993) ................................................................................. 1

Ass’n of American Physicians & Surgeons v. Mathews,

423 U.S. 975 (1975) ................................................................................................. 1

Ass’n of Am. Physicians & Surgs v. United States FDA, 13 F.4th 531 (6th Cir. 2021) ...... 4

Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) ......................................... 3

Cheney v. United States Dist. Court, 542 U.S. 367 (2004) ................................................. 1

Cmty. for Creative Non-Violence v. Pierce, 814 F.2d 663 (D.C. Cir. 1987) ................ 9, 10

District of Columbia v. Heller, 554 U.S. 570 (2008) .......................................................... 1

Gahl v. Aurora Health Care, Inc., 977 N.W.2d 756 (Wis. Ct. App. 2022) ........................ 7

Los Angeles v. Lyons, 461 U.S. 95 (1983) ...................................................................... 9-10

Meese v. Keene, 481 U.S. 465 (1987) ............................................................................... 11

Mountain States Legal Found. v. Glickman, 92 F.3d 1228 (D.C. Cir. 1996) .............. 10-11

Springer v. Henry, 435 F.3d 268 (3d Cir. 2006) ................................................................. 1

Stenberg v. Carhart, 530 U.S. 914 (2000) .......................................................................... 1

Texas v. United States, 945 F.3d 355 (5th Cir. 2019) ......................................................... 1

Tex. Health Huguley, Inc. v. Jones, 637 S.W.3d 202 (Tex. App. 2021) ......................... 7, 8

Tozzi v. HHS, 271 F.3d 301 (D.C. Cir. 2001).............................................................. 10, 11

United States v. Students Challenging Regulatory Agency Procedures,

412 U.S. 669 (1973) ............................................................................................... 10
Case 3:22-cv-00184 Document 29-1 Filed on 09/29/22 in TXSD Page 3 of 16

Other

Associated Press, “KS Sen. Mark Steffen sends letters to physicians

on COVID-19” (Apr. 6, 2022) ................................................................................. 9

Beck & Azari, “FDA, Off-Label Use, and Informed Consent: Debunking Myths and
Misconceptions,” 53 Food & Drug L. J. 71 (1998) .............................................................3

Congressional Research Service, “Off-Label Use of Prescription Drugs,”

(Feb. 23, 2021) https://sgp.fas.org/crs/misc/R45792.pdf ........................................ 4

Federal Drug Administration, “Understanding Unapproved Use of Approved Drugs

‘Off Label,’” (Feb. 5, 2018). https://www.fda.gov/patients/learn-about-expanded-
access-and-other-treatment-options/understanding-unapproved-use-approved-
drugs-label ............................................................................................................... 5

K. Miller, “Off-Label Drug Use: What You Need to Know,” WedMD
(2009). https://www.webmd.com/a-to-z-guides/features/off-label-drug-use-what-
you-need-to-know .................................................................................................... 5

Remarks by President Biden at Virtual Meeting on Military Deployments Supporting
Hospitals for the COVID-19 Response, The White House (January 13, 2022,
emphasis added), https://tinyurl.com/45ezsejt ......................................................... 8

Marilyn M. Singleton, M.D., J.D., “Dear AMA: The Oath of Hippocrates Is Enough,”
26 Journal of American Physicians and Surgeons 109 (Winter 2021).
https://www.jpands.org/vol26no4/singleton.pdf ................................................... 5-6

WHO, “Model List of Essential Medicines” (22nd list, 2021)
https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2021.02 ............ 5

https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-
treat-or-prevent-covid-19 ........................................................................................ 8

Case 3:22-cv-00184 Document 29-1 Filed on 09/29/22 in TXSD Page 4 of 16

IDENTITY, INTEREST AND AUTHORITY TO FILE1

Amicus curiae Association of American Physicians and Surgeons (“AAPS”) is a
national association of physicians. Founded in 1943, AAPS has been dedicated to the
highest ethical standards of the Oath of Hippocrates and to preserving the sanctity of the
patient-physician relationship. AAPS has been a litigant in federal courts. See, e.g.,
Cheney v. United States Dist. Court, 542 U.S. 367, 374 (2004) (citing Ass’n of American
Physicians & Surgeons v. Clinton, 997 F.2d 898 (D.C. Cir. 1993)); Ass’n of American
Physicians & Surgeons v. Mathews, 423 U.S. 975 (1975). In addition, the U.S. Supreme
Court has expressly made use of amicus briefs submitted by AAPS in high-profile cases.
See, e.g., Stenberg v. Carhart, 530 U.S. 914, 933 (2000); id. at 959, 963 (Kennedy, J.,
dissenting); District of Columbia v. Heller, 554 U.S. 570, 704 (2008) (Breyer, J.,
dissenting). Over the span of more than a decade, the Fifth and Third Circuits have
expressly cited an amicus brief by AAPS in the first paragraph of one of its decisions. See
Texas v. United States, 945 F.3d 355, 369 (5th Cir. 2019); Springer v. Henry, 435 F.3d
268, 271 (3d Cir. 2006). AAPS was the plaintiff in a decision relied upon by the
government here in its pending motion, which reinforces AAPS’s interest in this case.
(Govt Mot. 13)

1 The undersigned counsel certifies that counsel for the Amicus authored this brief in whole;
no counsel for a party authored this brief in any respect; and no person or entity – other
than Amicus, its members, and its counsel – contributed monetarily to this brief’s
preparation or submission. Amicus files an accompanying motion for leave to file this
brief, and all the parties have stated that they do not oppose this motion.
Case 3:22-cv-00184 Document 29-1 Filed on 09/29/22 in TXSD Page 5 of 16

Amicus AAPS members have direct and vital interests in the issues here,
particularly the interference by the FDA with the practice of medicine.
SUMMARY OF ARGUMENT
Defendant FDA has improperly exploited misunderstandings about the legality and
prevalence of off-label uses of medication, in order to mislead courts, state medical boards,
and the public into thinking there is anything improper about off-label prescribing. Not
only is off-label prescribing fully proper, legal, and commonplace, but it is also absolutely
necessary in order to give effective care to patients. It has never been proper for the FDA
to interfere with that essential part of the practice of medicine, and the FDA knows it. Yet
it has engaged in a campaign of interference with the proper use by physicians of
ivermectin, which has long been approved as fully safe for human use.
Multiple courts have been misled by the FDA’s improper campaign against this
medication that was approved as safe for humans decades ago, and the FDA has made no
attempt to retract its prior approval. In ruling against patients seeking access to ivermectin
to treat Covid-19, as recommended by their physicians, multiple courts have relied on the
misinformation and improper interference by the FDA as a basis for denying access now.
Defendant FDA lacks both the authority and the expertise to practice medicine,
interfere with the practice of medicine, guide the practice of medicine, or advise about the
practice of medicine. Federal law is clear about this, and common sense reinforces it. FDA
employees are not practicing physicians, and are not treating patients. FDA employees,
for the most part, are not even licensed physicians.
Case 3:22-cv-00184 Document 29-1 Filed on 09/29/22 in TXSD Page 6 of 16

States confer the sole authority on licensed physicians to decide whether to prescribe
an already-approved safe medication for a new off-label use, as is widely done. When
confronted with a new illness as Covid-19 has been, off-label use of available medications
is a necessary approach to effective treatment of that novel virus.
The injury caused by the FDA’s interference with the practice of medicine is to
many physicians, including members of Amicus AAPS and to plaintiffs here, who have
standing to object to the FDA’s harmful overreach. Reputations are harmed by falsely
disparaging physicians for proper prescriptions that coincidentally have veterinary uses, as
many drugs do. Nothing would be gained and much would be lost by barring this
meritorious claim at the courthouse steps without ever adjudicating it substantively.
ARGUMENT
I.
Off-Label Prescribing Is Necessary to Effective Medical Treatment, and the
FDA’s Interference Is Illegal.

As expressly recognized by the Supreme Court, “courts, several States, and the
‘FDA itself recognize the value and propriety of off-label use.’” Buckman Co. v.
Plaintiffs’ Legal Comm., 531 U.S. 341, 350 (2001) (quoting Beck & Azari, “FDA, Off-
Label Use, and Informed Consent: Debunking Myths and Misconceptions,” 53 Food &
Drug L. J. 71, 76-77 (1998)). The Supreme Court added that “‘[o]ff-label use is
widespread in the medical community and often is essential to giving patients optimal
medical care, both of which medical ethics, FDA, and most courts recognize.’”
Buckman, 531 U.S. at 351 n.5 (quoting Beck & Azari, 53 Food & Drug L. J. at 72,
emphasis added).
Case 3:22-cv-00184 Document 29-1 Filed on 09/29/22 in TXSD Page 7 of 16

It follows, from the recognition by the Supreme Court that off-label uses are
ethically required, that it is wholly improper for the FDA to interfere with such off-label
practices. Ivermectin has long been a medication fully approved as safe for humans.
That is where the FDA’s authority begins and ends. Beyond that, it is exclusively a
matter of state law in authorizing physicians to prescribe approved-as-safe medications
for the benefit of their patients. When a physician is fully licensed by a state to practice
medicine, then he has the authority without interference by the FDA to prescribe an
approved-as-safe medication such as ivermectin to treat Covid-19 or any other illness.
As observed by the Sixth Circuit, “the Federal Food, Drug, and Cosmetic Act …
does not bar doctors from prescribing an approved drug (like hydroxychloroquine) for an
off-label use (like COVID-19).” Ass’n of Am. Physicians & Surgs v. United States FDA,
13 F.4th 531, 544 (6th Cir. 2021). The same, of course, is true about ivermectin: the
FDA is without authority to interfere with prescriptions by physicians of this approved-
as-safe medication for treating Covid-19 or any other condition.
An article published in the peer-reviewed AAPS medical journal, by attorney and
physician Marilyn Singleton, M.D., J.D., explained in detail how essential off-label
prescribing is to the practice of effective medicine:
Prescribing a medication for a medical condition other than its FDA-approved
purpose is called “off-label” prescribing. According to the Congressional Research
Service (CRS) 56 percent of oncology and 12 to 38 percent of prescriptions overall
are written for uses not listed on the FDA-approved labeling.2 Off label prescribing

2 Congressional Research Service, “Off-Label Use of Prescription Drugs,” (Feb. 23,
2021). https://sgp.fas.org/crs/misc/R45792.pdf (viewed Sept. 27, 2022).
Case 3:22-cv-00184 Document 29-1 Filed on 09/29/22 in TXSD Page 8 of 16

is left to the judgment of the physician and is not only legal but ethical.3 G. Caleb
Alexander, MD, MS, a medical ethics advocate and assistant professor of medicine at
the University of Chicago Medical Center noted, “[o]ff-label use is so common, that
virtually every drug is used off-label in some circumstances. ... Doctors are free to
prescribe a drug for any [reason they think is medically appropriate].”4

Off-label prescribing allows patients to benefit from a drug without waiting years
for FDA approval. The CRS notes that off-label prescribing can reflect cutting-edge
clinical expertise or a new treatment approach when other options have failed. …

Some examples of off-label use are (1) tamoxifen approved for breast cancer and
used off label to treat infertility; (2) spironolactone, a diuretic used off label for acne
vulgaris; (3) beta blockers approved for treating high blood pressure, arrhythmias,
coronary artery disease, migraines, and glaucoma used off label for anxiety; and (4)
statins approved to lower cholesterol and used off-label to prevent heart attacks in
people with diabetes.

It could not be more clear that off-label use of approved medications is an accepted
and beneficial component of medical practice. Until COVID-19, off-label
prescribing had not faced particular scrutiny. Unfortunately for patients, two low-
cost repurposed medications that have been prescribed for years without incident
and are on the World Health Organization’s list of essential medications are being
blackballed.5 The truth is, numerous studies show that when started
early, hydroxychloroquine and ivermectin significantly reduce symptoms and
prevent hospitalizations and deaths.

Marilyn M. Singleton, M.D., J.D., “Dear AMA: The Oath of Hippocrates Is Enough,” 26

3 Federal Drug Administration, “Understanding Unapproved Use of Approved Drugs
‘Off Label,’” (Feb. 5, 2018). https://www.fda.gov/patients/learn-about-expanded-access-
and-other-treatment-options/understanding-unapproved-use-approved-drugs-label
(viewed Sept. 27, 2022).
4 K. Miller, “Off-Label Drug Use: What You Need to Know,” WedMD
(2009). https://www.webmd.com/a-to-z-guides/features/off-label-drug-use-what-you-
need-to-know (viewed Sept. 27, 2022).
5
WHO,
“Model
List
of
Essential
Medicines”
(22nd
list,
2021)
https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2021.02 (viewed Sept.
27, 2022).
Case 3:22-cv-00184 Document 29-1 Filed on 09/29/22 in TXSD Page 9 of 16

Journal of American Physicians and Surgeons 109, 111 (Winter 2021).6

Despite the clarity of federal law and common practice on this issue of off-label
prescribing, the FDA continues to illegally interfere with it as explained more fully in
plaintiffs’ Amended Complaint and brief in opposition to Defendants’ motion to dismiss.
See also Exh. 6 to plaintiffs’ Amended Complaint (FDA: “You are not a horse. Stop it
with the #ivermectin. It’s not authorized for treating #COVID.”). That statement by the
FDA of “not authorized” is misinformation of the worst kind. The FDA does not
specifically authorize the use of approved-as-safe medication for virtually any new use
deemed effective by physicians licensed to practice by their state medical boards.
II.
FDA’s Unjustified Overreach Has Propagated into Court Decisions and
State Medical Board Actions.

The FDA’s unauthorized and unjustified disparagement of physicians prescribing
ivermectin has wrongfully influenced multiple courts and state medical boards.
“Although a number of physicians across the country have prescribed ivermectin
to treat COVID-19, the Food and Drug Administration (FDA) has not approved
ivermectin for use in treating COVID-19 ….” Frey v. Trinity Health-Michigan, No.
359446, 2021 Mich. App. LEXIS 6988, at *2 (Ct. App. Dec. 10, 2021). Yet once the
FDA approves a drug as being safe, there is no reason for it to approve the drug again for
every new use of it, and neither the FDA nor drug manufacturers incur that senseless
additional expense. The drug is safe. It is solely within the authority of physicians to

6 https://www.jpands.org/vol26no4/singleton.pdf (viewed Sept. 27, 2022).
Case 3:22-cv-00184 Document 29-1 Filed on 09/29/22 in TXSD Page 10 of 16

prescribe approved-as-safe drugs for new uses.
FDA officials know but disregard this. They insisted and continue to insist on
interfering with the prescription of this safe medication by physicians in treating Covid-
19. The FDA’s illegal public stance became part of court decisions, disciplinary actions,
public confusion, refusal by pharmacists to fill valid prescriptions, and countless deaths
of Covid-19 patients due to denial of this early treatment.
“Throughout the October 12 hearing, the circuit court repeatedly questioned the
parties to elicit additional information and greater detail. For example, the circuit court
asked questions regarding the Food and Drug Administration’s (FDA) position regarding
ivermectin as a COVID-19 treatment.” Gahl v. Aurora Health Care, Inc., 977 N.W.2d
756, 782 (Wis. Ct. App. 2022).
One of the state courts misled by the FDA was in litigation involving a plaintiff in
this case, Dr. Mary Bowden. The court ruled against her attempt to treat a patient with
ivermectin because:
while … Ivermectin has already been approved by the FDA for unrelated illnesses,
and that it may have an effective off-label use in the treatment of COVID-19, using
a drug off-label is not the same thing as using it after a phase-one clinical trial while
FDA approval is pending.

Tex. Health Huguley, Inc. v. Jones, 637 S.W.3d 202, 219-20 (Tex. App. 2021). In this
same case the Texas state court observed:
The doctor explained that he had not prescribed Ivermectin while treating Mr.
Jones’s COVID-19 because the Food and Drug Administration (FDA) had issued
a warning that the drug should not be used for COVID-19 treatment, and because,
likely for the same reason, the drug was not part of Huguley’s COVID-19 protocol.

Case 3:22-cv-00184 Document 29-1 Filed on 09/29/22 in TXSD Page 11 of 16

Tex. Health Huguley, 637 S.W.3d at 209 n.12 (emphasis added). This is undeniable
reliance on the FDA’s unjustified overreach in its authority.
The FDA’s bizarre photo of a woman dressed as a physician standing next to a
horse, which remains posted on the FDA website7 and is complained about in plaintiffs’
pleading here, was slick and improper. See also Exh. 6 to plaintiffs’ Amended Complaint
(quoted above). The FDA further interfered by writing to the Federation of State Medical
Boards and the National Association of Boards of Pharmacy. (Govt Mot. 9) Despite
being biased misinformation as the FDA well knows, it is cited as an authority on this by
courts, medical boards, other parts of the federal government, and confused members of
the public. Ironically, while the FDA was interfering with the practice of informed
physicians in treating patients, the Biden Administration has been demanding that social
media take down postings that the Biden disliked, perhaps because it contradicted him: “I
make a special appeal to social media companies and media outlets: Please deal with the
misinformation and disinformation that’s on your shows. It has to stop.”8
State medical boards have been unjustifiably investigating physicians for
prescribing off-label uses of ivermectin for Covid-19 patients, which newspapers and
others pejoratively describe as a “deworming” medication based on the misinformation

7 https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-
treat-or-prevent-covid-19 (viewed Sept. 27, 2022).
8 Remarks by President Biden at Virtual Meeting on Military Deployments Supporting
Hospitals for the COVID-19 Response, The White House (January 13, 2022, emphasis
added), https://tinyurl.com/45ezsejt (viewed Sept. 28, 2022).
Case 3:22-cv-00184 Document 29-1 Filed on 09/29/22 in TXSD Page 12 of 16

put out by the FDA. “A Kansas physician-legislator who has acknowledged that he is
under investigation by the state medical board after supporting the deworming drug
ivermectin is instructing doctors on COVID-19 treatment in a letter.” Associated Press,
“KS Sen. Mark Steffen sends letters to physicians on COVID-19” (Apr. 6, 2022). That
Associated Press article, which is typical of media recitation of the FDA’s
misinformation, concludes that “[t]he FDA has tried to debunk claims that animal-
strength versions of ivermectin can help fight COVID-19.” Id.
III.
Legal Standing Exists to Challenge Devastating, Unauthorized Falsehoods by
Government.

The government seeks to avert substantive review here by challenging the legal
standing of plaintiffs. (Govt Mot. 11-17) But AAPS, as an association of physicians
many of whom having been treated Covid-19 patients since early 2020, can attest that the
impact of defendants’ actions beyond their authority has been causing real harm to
practicing physicians, including plaintiffs.
In addition to the precedents for standing cited by plaintiffs in their brief, see, e.g.,
Block v. Meese, 793 F.2d 1303 (1986) (Scalia, J.), several more decisions support
standing here. See, e.g., Cmty. for Creative Non-Violence v. Pierce, 814 F.2d 663 (D.C.
Cir. 1987). There the D.C. Circuit found that homeless men had standing to challenge a
report issued by the Department of Housing and Urban Development (“HUD”), based on
the likelihood of being turned away from a homeless shelter due to it. Id. at 667-68. The
D.C. Circuit pointed out that it “is sufficient to provide standing that the ultimate harm
alleged is a threatened harm rather than an accomplished fact.” Id. at 667 (citing Los
Case 3:22-cv-00184 Document 29-1 Filed on 09/29/22 in TXSD Page 13 of 16

Angeles v. Lyons, 461 U.S. 95, 101-02 (1983); United States v. Students Challenging
Regulatory Agency Procedures, 412 U.S. 669, 688-89 (1973)).
Likewise, state medical boards and even court decisions as cited above have been
relying on the unauthorized and false pronouncements by defendants, to the detriment of
plaintiffs. While not homeless as a result, plaintiffs face interference with their
professional careers and thus their likelihood. They face public disgrace as a result of
defendants’ improper actions. This suffices to establish standing by plaintiffs here.
A decision concerning the upgrade of dioxin to be categorized as a “known”
carcinogen by HHS, which found standing by a private manufacturer to challenge that
redesignation, is analogous to the existence of standing by plaintiffs here. See Tozzi v.
HHS, 271 F.3d 301 (D.C. Cir. 2001). There the D.C. Circuit held that:
Even if the Department’s claims were true, we disagree that Brevet has failed to
show that its injury is fairly traceable to the dioxin upgrade. … Where, as here, the
alleged injury flows not directly from the challenged agency action, but rather from
independent actions of third parties, we have required only a showing that “the
agency action is at least a substantial factor motivating the third parties’ actions.”
Cmty. for Creative Non-Violence v. Pierce, 259 U.S. App. D.C. 134, 814 F.2d 663,
669 (D.C. Cir. 1987). …

Applying this standard to the facts of this case, we have little doubt that the dioxin
upgrade will represent a “substantial factor” in the decisions of state and local
agencies to regulate products containing dioxin or of healthcare companies to reduce
or end purchases of PVC plastics. …

An additional factor reinforces our conclusions regarding both injury and causation:
When the government attaches an inherently pejorative and damaging term such as
“carcinogen” to a product, the probability of economic harm increases
exponentially. The Department’s reliance on Block, in which the government’s
label of “propaganda” was not inherently pejorative, is therefore misplaced. It is not
too speculative to conclude that the Report will injure Brevet economically, even
with the presence of other causal factors. See, e.g., Mountain States Legal Found. v.
Case 3:22-cv-00184 Document 29-1 Filed on 09/29/22 in TXSD Page 14 of 16

Glickman, 320 U.S. App. D.C. 87, 92 F.3d 1228, 1234-35 (D.C. Cir. 1996) (holding
incremental risk of forest fires from Forest Service’s challenged decision sufficient
to support Article III standing, despite existence of other causal factors for forest
fires).

Tozzi v. HHS, 271 F.3d at 308-09 (citations omitted).
Standing was also found by the Supreme Court in Meese v. Keene, in recognizing
standing there despite an objection to it by the Department of Justice:
Because the alleged injury stems from the Department of Justice's enforcement of a
statute that employs the term “political propaganda,” we conclude that the risk of
injury to appellee’s reputation “fairly can be traced” to the defendant’s conduct.
Simon v. Eastern Kentucky Welfare Rights Organization, 426 U.S. 26, 41 (1976).

Moreover, enjoining the application of the words “political propaganda” to the films
would at least partially redress the reputational injury of which appellee
complains. The Attorney General argues that an injunction would not provide
the relief sought, because appellee’s constituents and others may continue to react
negatively to his exhibition of films once they have been labeled as “political
propaganda.” However, appellee’s alleged harm occurs because the Department of
Justice has placed the legitimate force of its criminal enforcement powers behind
the label of “political propaganda.” A judgment declaring the Act unconstitutional
would eliminate the need to choose between exhibiting the films and incurring …
reputation[al harm].

Meese v. Keene, 481 U.S. 465, 476-77 (1987).
Similarly, the strong disparagement by the FDA of using ivermectin to treat
Covid-19 is sufficient to justify standing by plaintiffs here, as treating physicians, to
object to that unauthorized disparagement. Standing exists regardless of how the ultimate
merits of this case may be resolved.

Case 3:22-cv-00184 Document 29-1 Filed on 09/29/22 in TXSD Page 15 of 16

CONCLUSION

For the foregoing reasons and those set forth by plaintiffs in their brief, Amicus
AAPS respectfully requests that the pending motion to dismiss by defendants be denied in
its entirety.

Dated: September 29, 2022

Respectfully submitted,

/s/ Andrew L. Schlafly

Andrew L. Schlafly
Attorney-in-charge
State of N.J. Bar ID 04066-2003
SD Texas Bar ID NJ04066
939 Old Chester Rd.
Far Hills, NJ 07931
Tel: 908-719-8608
Fax: 908-934-9207
Email: aschlafly@aol.com
Counsel for Amicus Association of
American Physicians and Surgeons

CERTIFICATE OF WORD AND PAGE COUNTS

I hereby certify that the total number of words in this document, exclusive of
sections properly omitted from this count, is 3,139 words as indicated by Microsoft
Word, and that its page length is 12 pages. I further certify that this document is in size
13 Times New Roman font.
/s/ Andrew L. Schlafly

Andrew L. Schlafly

CERTIFICATE OF SERVICE

I hereby certify that on this September 29, 2022, I caused service of all the parties
of the foregoing document through operation of the Court’s CM/ECF system.

/s/ Andrew L. Schlafly

Andrew L. Schlafly
Case 3:22-cv-00184 Document 29-1 Filed on 09/29/22 in TXSD Page 16 of 16

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Amicus curiae brief — Apter v. HHS

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