Court filing
Amicus curiae brief (America's Frontline Doctors) — Apter v. HHS
Filed October 6, 2022 in Apter v. Department of Health and Human Services; one of 66 filings from this case.
Record facts
| Court | U.S. District Court for the Southern District of Texas, Galveston Division |
|---|---|
| Filed | 2022-10-06 |
U.S. District Court for the Southern District of Texas, Galveston Division · No. 3:22-cv-00184 · Doc. 35-1 · 2022-10-06 · Docket on CourtListener
Full text
IN THE UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF TEXAS
GALVESTON DIVISION
No. 3:22-cv-184
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
AMICUS CURIAE BRIEF OF AMERICA’S FRONTLINE DOCTORS
Respectfully Submitted,
David A. Dalia
Attorney at Law
830 Union Street, Suite 302
New Orleans, LA 70112
T: 504-524-5541
davidadalia@gmail.com
Lauren E. Bradford
Attorney at Law
1645 W. Valencia Road, Ste 109 #19
Tucson, AZ 85746-6099
Laurenbradford@aflds.org
Counsel for Amicus Curiae,
America’s Frontline Doctors
Case 3:22-cv-00184 Document 35-1 Filed on 10/06/22 in TXSD Page 1 of 21
TABLE OF CONTENTS
Table of Contents.....................................................................................ii
Table of Authorities.................................................................................iii
Summary of Argument.............................................................................1
Argument..................................................................................................2
A. The FDA’s public pressure campaign to discourage or prohibit
ivermectin use is blatantly illegal. To the extent of our knowledge, this is
singularly unprecedented in the history of the agency, and infringes on
physician free speech rights.
B. Any FDA statements have an outsized influence in healthcare, and even
nonbinding advisory opinions severely interfere with the practice of
medicine.
C. Ivermectin is one of the safest drugs on the market. It has been
used hundreds of millions of times, and there is significant evidence that
ivermectin is effective at treating COVID-19.
-ii-
Case 3:22-cv-00184 Document 35-1 Filed on 10/06/22 in TXSD Page 2 of 21
TABLE OF AUTHORITIES
Cases
Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350 (2001).........1,3
Griswold, et. al. v. Connecticut, 381 U.S. 479, 85 S.Ct. 1678, 14 L.Ed.2d
510 (1965)......................................................................................................................5,6
Markland v. Insys Therapeutics, Inc., 758 F. App’x 777, 780 (11th Cir.
2018)............................................................................................. ...............1,3
National Institute of Family and Life Advocates, dba NIFLA, et. al. v.
Becerra, Attorney General of California, et. al., 585 U.S. ___, 138 S. Ct.
2361, 201 L. Ed. 2d 835 (2018)......................................................................6
Planned Parenthood Cincinnati Region v. Taft, 444 F.3d. 502, 505 (6th Cir.
2006)............................................................................................................1,3
Smith v. C.R. Bard, Inc., 730 F. Supp. 2d 783, 803 (M.D. Tenn. 2010).....1,3
United States v. Caronia, 703 F.3d 149, 167 (2d Cir. 2012)......................1,3
U.S. ex rel King v Solvay Pharms, Inc, 871 F.3d 318, 328 (5th Cir. 2017)1,3
United States v. Muoghalu, 662 F.3d 908, 911 (7th Cir. 2011)...................1,3
U.S. ex rel. Nathan v. Takeda Pharms. N. Am., Inc., 707 F.3d 451, 454 n.2
(4th Cir. 2013).............................................................................................1,3
-iii-
Case 3:22-cv-00184 Document 35-1 Filed on 10/06/22 in TXSD Page 3 of 21
Statutes and Regulations
21 U.S.C. §396.............................................................................................1,3
21 C.F.R. § 312.2(d)....................................................................................1,3
Internet Authorities
https://en.wikipedia.org/wiki/Food_and_Drug_Administration .................4
https://www.fda.gov/files/drugs/published/A-History-of-the-FDA-and-Drug
-Regulation-in-the-United-States.pdf ...........................................................4
https://www.ahrq.gov/patients-consumers/patient-involvement/off-label-dru
g-usage.html#:~:text=Off%2Dlabel%20prescribing%20is%20when,are%20
for%20off%2Dlabel%20use .........................................................................5
Letter To Pharmacy Board On Preventing The Use Of Ivermectin
https://agjefflandry.com/Files/Shared/Documents/Pharmacyboardletter9.7.2
1.pdf ...............................................................................................................7
Oklahoma AG OKs prescribing ivermectin, hydroxychloroquine”
https://www.usnews.com/news/best-states/oklahoma/articles/2022-02-08/ok
lahoma-ag-oks-prescribing-ivermectin-hydroxychloroquine .......................8
Nebraska AG issues opinion on Ivermectin and Hydroxychloroquine
https://www.ketv.com/article/nebraska-ag-issues-opinion-on-ivermectin-and
-hydroxychloroquine-as-covid-19-treatments/37973809# .................................8
The Scotfree | South Carolina Attorney General Confirms Support of
Ivermectin Bill:
https://www.scag.gov/about-the-office/news/attorney-general-alan-wilson-is
sues-opinion-on-the-legality-of-doctors-prescribing-alternative-drugs-to-tre
at-covid ............................................................................................................................8
Kesselheim AS, Woloshin S, Lu Z, Tessema FA, Ross KM, Schwartz LM.
Physicians' Perspectives on FDA Approval Standards and Off-label Drug
Marketing. JAMA Intern Med. 2019 May 2019
-iv-
Case 3:22-cv-00184 Document 35-1 Filed on 10/06/22 in TXSD Page 4 of 21
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6503563/ .........................8
https://www.ukessays.com/essays/psychology/implications-of-stanley-milgr
ams-1963-study-on-obedience-on-the-clinical-environment.php
https://www.simplypsychology.org/milgram.html ..............................................9
See Peter R Breggin MD, Ginger Ross Breggin, COVID-19 and the Global
Predators: We are the Prey 147 (2021).
The Emergency Use Authorization is part of Federal Food, Drug, and
Cosmetic Act, Pub.L.No. 75-717 (as amended at 21 U.S.C. §§ 301-399f). It
is interpreted and applied by the FDA ........................................................10
Crump, A. Ivermectin: enigmatic multifaceted ‘wonder’ drug continues to
surprise and exceed expectations. J Antibiot 70, 495–505 (2017).
https://www.nature.com/articles/ja201711#citeas ......................................10
P. Kory et. al. Review of the Emerging Evidence Demonstrating the Efficacy
of Ivermectnig in the Prophylaxis and Treatment of COVID-19 American
Journal of Therapueutics: amy/June 2021 – volume 28 – Issue 3
-https://journals.lww.com/americantherapeutics/fulltext/2021/06000/review
_of_the_emerging_evidence_demonstrating_the.4.aspx ...........................11
Crump A, Ōmura S. Ivermectin, 'wonder drug' from Japan: the human use
perspective. Proc Jpn Acad Ser B Phys Biol Sci. 2011;87(2):13-28. doi:
10.2183/pjab.87.13. PMID: 21321478; PMCID: PMC3043740.
https://pubmed.ncbi.nlm.nih.gov/21321478/ ..............................................11
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3043740 .............................11
Heidary, F., Gharebaghi, R. Ivermectin: a systematic review from antiviral
effects to COVID-19 complementary regimen. J Antibiot 73, 593–602
(2020). https://www.nature.com/articles/s41429-020-0336-z#citeas .........11
https://journals.lww.com/americantherapeutics/Fulltext/2021/06000/Review
_of_the_Emerging_Evidence_Demonstrating_the.4.aspx ..............................12
Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved
drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral
Res. 2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub
-v-
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2020 Apr 3. PMID: 32251768; PMCID: PMC7129059.
https://pubmed.ncbi.nlm.nih.gov/32251768/ ..............................................12
MERCK. 35 Years: The Mectizan Donation Program. January 6, 2021.
https://www.merck.com/stories/mectizan/ ..................................................12
The Nobel Prize. PRESS RELEASE. 2015-10-05.
https://www.nobelprize.org/prizes/medicine/2015/press-release/ ..............12
Veeresham C. Natural products derived from plants as a source of drugs. J
Adv Pharm Technol Res. 2012 Oct;3(4):200-1. doi:
10.4103/2231-4040.104709. PMID: 23378939; PMCID: PMC3560124.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3560124/ .......................13
Rajter JC, Sherman MS, Fatteh N, Vogel F, Sacks J, Rajter JJ. Use of
Ivermectin Is Associated With Lower Mortality in Hospitalized Patients
With Coronavirus Disease 2019: The Ivermectin in COVID Nineteen Study.
Chest. 2021 Jan;159(1):85-92. doi: 10.1016/j.chest.2020.10.009. Epub 2020
Oct 13. PMID: 33065103; PMCID: PMC7550891.
https://pubmed.ncbi.nlm.nih.gov/33065103/ .............................................13
FLCCC ALLIANCE. One Page Summary of the Clinical Trials Evidence
for Ivermectin in COVID-19 as of January 11, 2021.
https://covid19criticalcare.com/wp-content/uploads/2020/12/One-Page-Sum
mary-of-the-Clinical-Trials-Evidence-for-Ivermectin-in-COVID-19.pdf ...13
-vi-
Case 3:22-cv-00184 Document 35-1 Filed on 10/06/22 in TXSD Page 6 of 21
SUMMARY OF ARGUMENT
In 2021 the Food and Drug Administration (“FDA”) illegally launched an
anti-ivermecin propaganda campaign, in direct violation of federal law, 21 U.S.C.
§396, and 21 C.F.R. § 312.2(d). Accordingly, this lawsuit, filed by three very
distinguished plaintiff physicians, is well founded and should not be dismissed,
because these blatantly illegal governmental actions must be curtailed. The
plaintiff physicians have alleged multiple serious harms to their medical practices,
and to their livelihoods, sufficient to justify standing.
As plaintiffs critically point out in their Complaint, Paras 57-60:
“ 57. Courts have consistently cited [21U.S.C.] § 396 as applying to the
prescription or administration of drugs as well. See Markland v. Insys
Therapeutics, Inc., 758 F. App’x 777, 780 (11th Cir. 2018); U.S. ex rel King
v. Solvay Pharms., Inc., 871 F.3d 318, 328 (5th Cir. 2017); 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); Smith v. C.R. Bard,
Inc., 730 F. Supp. 2d 783, 803 (M.D. Tenn. 2010).
58. The FDA thus cannot 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 Buckman Co. v.
Plaintiffs’ Legal Comm., 531 U.S. 341, 350 (2001).
60. FDA regulations recognize that the agency cannot interfere with the
practice of medicine or off-label use of approved drugs. 21 C.F.R. §
312.2(d) (“This part does not apply to the use in the practice of medicine for
an unlabeled indication of a new drug product approved under part 314 or
of a licensed biological product.”).”
-1-
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The statutes, regulations and jurisprudence cited above are totally
determinative of the indisputable fact that the Food and Drug Administration
crossed the legal red line in this case.
The FDA’s blatantly illegal public pressure campaign to discourage or
prohibit ivermectin use, is to the extent of our knowledge, singularly
unprecedented in the history of the agency. Any FDA statements have an outsized
influence in healthcare. Even non-binding advisory opinions severely interfere
with the practice of medicine in general and with the plaintiffs’ practice of
medicine in particular.
Finally, ivermectin is one of the safest drugs on the market. It has been used
hundreds of millions of times. There is significant evidence that ivermectin is
effective at treating COVID-19, which evidence directly refutes the illegal
propaganda campaign being waged against ivermectin by the Food and Drug
Administration.
ARGUMENT
A. The FDA’s public pressure campaign to discourage or prohibit ivermectin
use is blatantly illegal. To the extent of our knowledge, this is singularly
unprecedented in the history of the agency, and infringes on physician free speech
rights.
The statutes, regulations, and jurisprudence cited above prove conclusively
-2-
Case 3:22-cv-00184 Document 35-1 Filed on 10/06/22 in TXSD Page 8 of 21
that the Food and Drug Administration violated federal law by illegally intruding
upon the protected doctor/patient relationship, when it launched its inaccurate and
ill-advised propaganda campaign against the use of ivermectin to treat COVID-19.
Please see 21 U.S.C. §396, 21 C.F.R. § 312.2(d), Markland v. Insys Therapeutics,
Inc., 758 F. App’x 777, 780 (11th Cir. 2018); U.S. ex rel King v. Solvay Pharms.,
Inc., 871 F.3d 318, 328 (5th Cir. 2017); 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); Smith v. C.R. Bard, Inc., 730 F. Supp. 2d 783, 803 (M.D. Tenn. 2010);
Planned Parenthood Cincinnati Region v. Taft, 444 F.3d. 502, 505 (6th Cir.
2006); and Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350 (2001).
The defendants acknowledge on page 1 of their motion to dismiss that, in
addition to concerns about the human use of animal-grade ivermectin, the FDA’s
pressure campaign also cautioned against the human use of human-grade
ivermectin, a decision strictly reserved to the medical profession. This admission
establishes a per se legal violation. Further, on pages 11-15 of the plaintiff
physicians’ opposition to the motion to dismiss, plaintiff physicians enumerate
numerous serious harms that they have directly suffered as a result of the illegal
Food and Drug Administration pressure campaign, amply conferring standing
-3-
Case 3:22-cv-00184 Document 35-1 Filed on 10/06/22 in TXSD Page 9 of 21
upon plaintiffs. Indeed, the harms inflicted upon the plaintiff physicians were
major and significant. The Food and Drug Administration is not permitted by law
to interfere with the plaintiff physicians’ relationships with their patients, their
medical boards, their insurance companies, and their very livelihoods.
The FDA was formed on June 30, 1906, as a federal agency under the aegis
of the U.S. Department of Health and Human Services (“DHH”). The FDA is
charged with the purported responsibility of “protecting and promoting public
health through the control and supervision of food safety, tobacco products,
dietary supplements, prescription and over-the-counter pharmaceutical drugs
(medications), vaccines, biopharmaceuticals, blood transfusions, medical devices,
electromagnetic radiation emitting devices (ERED), cosmetics, animal foods &
feed and veterinary products.”1
However, throughout its 116-year existence, the FDA has never prohibited
physicians from using drugs – including the common and well-established medical
practice of prescribing off-label drugs.2
In fact, it is common medical practice to prescribe off-label drugs. One in
1https://en.wikipedia.org/wiki/Food_and_Drug_Administration
2https://www.fda.gov/files/drugs/published/A-History-of-the-FDA-and-Dru
g-Regulation-in-the-United-States.pdf
-4-
Case 3:22-cv-00184 Document 35-1 Filed on 10/06/22 in TXSD Page 10 of 21
five prescriptions today are prescribed for off-label use.3
Doctors do not forfeit their constitutional rights when they earn their
medical degrees. On the contrary, like the physician plaintiffs herein, they are
well-trained professionals who can deliver considered professional opinions based
on their experience, research, and clinical practices with numerous patients. Other
doctors may have different considered professional opinions. Professional
opinions, of course, sometimes differ. We are all familiar with the “battle of the
experts” in the context of lawsuits.
There is no basis in American law or society for a government agency such
as the FDA, other than the fact-finding judge or jury assigned to a particular case
with competing experts, to declare one expert or the other to be the
government-approved version of the truth. And there is certainly no basis to
threaten or attempt to silence experts -- including U.S. doctors, for not supporting
a government-approved version of the “truth.”
This is not the first time protected free speech and privacy rights of doctors
in the doctor/patient relationship were attacked by American government officials
who disagreed with those opinions. In fact, one of the most famous free speech
3https://www.ahrq.gov/patients-consumers/patient-involvement/off-label-dr
ug-usage.html#:~:text=Off%2Dlabel%20prescribing%20is%20when,are%20for%
20off%2Dlabel%20use.
-5-
Case 3:22-cv-00184 Document 35-1 Filed on 10/06/22 in TXSD Page 11 of 21
and privacy cases of modern times, Griswold, et. al. v. Connecticut, 381 U.S. 479,
85 S.Ct. 1678, 14 L.Ed.2d 510 (1965), was just such a case.
In Griswold, a doctor was criminally convicted under a Connecticut statute
for counseling a married couple regarding contraception. In reversing the doctor’s
conviction, the Supreme Court found that the doctor’s treatments, associations and
doctor/patient privacy rights were protected by the penumbras emanating from the
First, Fourth, and Ninth Amendments, affirming the principle that the concept of
liberty protects personal fundamental human rights.
More recently, the United States Supreme Court decided the important case
of National Institute of Family and Life Advocates, dba NIFLA, et. al. v. Becerra,
Attorney General of California, et. al., 585 U.S. ___, 138 S. Ct. 2361, 201 L. Ed.
2d 835 (2018). The California Reproductive Freedom, Accountability,
Comprehensive Care, and Transparency Act (“FACT Act”) similarly attempted to
impose analogous “content moderation” (i.e., mandatory medical speech) upon
health care providers. The FACT Act required pro-life health care clinics to inform
patients that free or low-cost abortions were available in California and required
the clinics to give the patients a telephone number to call for those services. The
United States Supreme Court held that this law was likely an unconstitutional
violation of the First Amendment. The NIFLA Court noted that content-based laws
-6-
Case 3:22-cv-00184 Document 35-1 Filed on 10/06/22 in TXSD Page 12 of 21
targeting speech based on its communicative content, which compel speakers to
speak a particular message, are presumptively unconstitutional.
Many state Attorneys General have joined the United States Supreme Court
in its support of medical freedom, medical privacy, and freedom of speech. A
survey of state Attorneys General around the country reveals that the Attorneys
General and Surgeons General from many states, including Nebraska, Missouri,
Louisiana, Kansas, New Hampshire, Florida, Oklahoma, and South Carolina, all
share similar views.
Last September 2021, for example, Louisiana Attorney General Jeff Landry
became the first attorney general to publicly endorse his support for ivermectin
(and hydroxychloroquine) prescriptions. In a letter to the Louisiana Board of
Pharmacy, with a copy to the Louisiana State Medical Board, he cautioned them
both on preventing the use of ivermectin. Attorney General Landry wrote, “I find
nothing that would allow the Board to second guess the sound medical judgment
of a doctor when it comes to prescribing legal drugs to their patients.”4
The same logic applies to the FDA.
4Letter To Pharmacy Board On Preventing The Use Of Ivermectin
https://agjefflandry.com/Files/Shared/Documents/Pharmacyboardletter9.7.21.pdf
-7-
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The Oklahoma Attorney General also supports ivermectin prescriptions5, as
does the Nebraska Attorney General6 and the South Carolina Attorney General.7
The FDA’s unprecedented anti-ivermectin propaganda campaign unlawfully
interferes with the doctor/patient relationship.
B. Any FDA statements have an outsized influence in healthcare, and
even nonbinding advisory opinions severely interfere with the practice
of medicine.
As a federal agency, the FDA cannot create or enforce laws. However, the
FDA has an undue influence on most physicians. One study concluded as many as
80% of physicians favorably view the FDA’s drug approval regulations agreeing
that its approval process helps “protect the public from ineffective or dangerous
drugs.”8
5Oklahoma AG OKs prescribing ivermectin, hydroxychloroquine”
https://www.usnews.com/news/best-states/oklahoma/articles/2022-02-08/oklahom
a-ag-oks-prescribing-ivermectin-hydroxychloroquine
6Nebraska AG issues opinion on Ivermectin and Hydroxychloroquine
https://www.ketv.com/article/nebraska-ag-issues-opinion-on-ivermectin-and-hydr
oxychloroquine-as-covid-19-treatments/37973809#
7The Scotfree | South Carolina Attorney General Confirms Support of
Ivermectin Bill:
https://www.scag.gov/about-the-office/news/attorney-general-alan-wilson-issues-o
pinion-on-the-legality-of-doctors-prescribing-alternative-drugs-to-treat-covid
8Kesselheim AS, Woloshin S, Lu Z, Tessema FA, Ross KM, Schwartz LM.
Physicians' Perspectives on FDA Approval Standards and Off-label Drug
-8-
Case 3:22-cv-00184 Document 35-1 Filed on 10/06/22 in TXSD Page 14 of 21
The famous Stanley Milgram experiments of the early 1960s disclose that
most people unquestionably obey perceived figures in authority figures, especially
ones in white lab coats.9
As plaintiff Dr. Apter notes in Para.18 of his Complaint: “Dr. Apter has
been referred to the Washington Medical Commission and Arizona Medical Board
for disciplinary proceedings for prescribing ivermectin to treat COVID-19. Id. The
referrals include copies of the FDA’s publications directing against the use of
ivermectin to treat COVID-19. Id. He explains that state regulatory boards rely
heavily on pronouncements from the FDA. Id. at 3.”
Also, as Dr. Breggin, a psychiatrist who possesses decades of experience, is
the author of multiple books on psychiatric topic and drugs, and is an expert
witness in several high-profile pharmaceutical lawsuits, notes, “The worldwide
suppression of hydroxychloroquine and now ivermectin, even at the direct cost of
lives, is so inexplicable that before describing the situation further, it may help to
answer the question, ‘Why is it so necessary for the establishment to suppress
Marketing. JAMA Intern Med. 2019 May 2019
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6503563/
9https://www.ukessays.com/essays/psychology/implications-of-stanley-milg
rams-1963-study-on-obedience-on-the-clinical-environment.php
https://www.simplypsychology.org/milgram.html
-9-
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inexpensive, easily available treatments for COVID-19? The answer is this: If
effective treatments are already available, the FDA cannot issue Emergency Use
Authorizations (EUAs), allowing the FDA to skip its usual safety and
effectiveness studies to push expensive, highly remunerative drugs and vaccines
down the pipeline as experiments to be inflicted on the population.”10
C. Ivermectin is one of the safest drugs on the market. It has been
used hundreds of millions of times, and there is significant evidence that
ivermectin is effective at treating COVID-19.
The discovery of ivermectin and its enormously beneficial medicinal
properties cannot be overstated. The unique and extraordinary microorganism that
produces the avermectins (from which ivermectin is derived) was discovered in
1973 in Japanese soil by biochemist Satoshi Ōmura, who won the Nobel Prize for
the discovery of ivermectin.11 Together with another Nobel-Prize-awarded Irish
biologist, William Campbell, who worked at the Merck Institute for Therapeutic
10 See Peter R Breggin MD, Ginger Ross Breggin, COVID-19 and the
Global Predators: We are the Prey 147 (2021).
The Emergency Use Authorization is part of Federal Food, Drug, and Cosmetic
Act, Pub.L.No. 75-717 (as amended at 21 U.S.C. §§ 301-399f). It is interpreted
and applied by the FDA.
11Crump, A. Ivermectin: enigmatic multifaceted ‘wonder’ drug continues to
surprise and exceed expectations. J Antibiot 70, 495–505 (2017).
https://www.nature.com/articles/ja201711#citeas
-10-
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Research, they discovered the soil-based bacteria could cure mice infected with
roundworm.12 Ivermectin was thus originally recognized as an anti-parasitic and
veterinary drug. However, it soon gained worldwide popularity as a miraculous
drug that could treat and cure a vast array of human diseases. Human distribution
began in the late 1980s, and has since helped cure millions from Onchocerciasis
(or River Blindness) and Lymphatic filariasis (or Elephantiasis).13 It’s hard to
overstate the immeasurable beneficial impact on the lives of millions of people
throughout the world due to the discovery of ivermectin. It has been rightfully
described by many clinicians as a “wonder drug”.14 Ivermectin contains
antimicrobial, antiviral, anti-inflammatory, and anti-cancer properties. To that end,
it has recently been proven to be a powerful prophylaxis and treatment for
12 P. Kory et. al. Review of the Emerging Evidence Demonstrating the
Efficacy of Ivermectnig in the Prophylaxis and Treatment of COVID-19 American
Journal of Therapueutics: amy/June 2021 – volume 28 – Issue 3
-https://journals.lww.com/americantherapeutics/fulltext/2021/06000/review_of_th
e_emerging_evidence_demonstrating_the.4.aspx
13 Crump A, Ōmura S. Ivermectin, 'wonder drug' from Japan: the human use
perspective. Proc Jpn Acad Ser B Phys Biol Sci. 2011;87(2):13-28. doi:
10.2183/pjab.87.13. PMID: 21321478; PMCID: PMC3043740.
https://pubmed.ncbi.nlm.nih.gov/21321478/
14https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3043740
-11-
Case 3:22-cv-00184 Document 35-1 Filed on 10/06/22 in TXSD Page 17 of 21
COVID-19.15 There is an abundance of irrefutable scientific evidence to support
the defense of ivermectin as a legally approved treatment which has been proven
safe and effective.16
Therefore, the FDA propaganda campaign against ivermectin was not only
illegal, it was also completely incorrect and dangerous from a medical standpoint.
In addition to the papers footnoted in this amicus curiae brief, a plethora of
prestigious scientific resources support ivermectin in treating COVID-19:
1. Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved
drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res.
2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub 2020 Apr 3.
PMID: 32251768; PMCID: PMC7129059.
https://pubmed.ncbi.nlm.nih.gov/32251768/
2. MERCK. 35 Years: The Mectizan Donation Program. January 6, 2021.
https://www.merck.com/stories/mectizan/
3. The Nobel Prize. PRESS RELEASE. 2015-10-05.
https://www.nobelprize.org/prizes/medicine/2015/press-release/
15 Heidary, F., Gharebaghi, R. Ivermectin: a systematic review from antiviral
effects to COVID-19 complementary regimen. J Antibiot 73, 593–602 (2020).
https://www.nature.com/articles/s41429-020-0336-z#citeas
16https://journals.lww.com/americantherapeutics/Fulltext/2021/06000/Revie
w_of_the_Emerging_Evidence_Demonstrating_the.4.aspx
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4. Veeresham C. Natural products derived from plants as a source of drugs. J Adv
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5. Rajter JC, Sherman MS, Fatteh N, Vogel F, Sacks J, Rajter JJ. Use of Ivermectin
Is Associated With Lower Mortality in Hospitalized Patients With Coronavirus
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CONCLUSION
The brave plaintiff physicians are on the right side of history. The FDA should
never illegally cross the line and overreach into the practice of medicine again. This
disrupts the protected doctor/patient relationship, endangers patients, and causes
significant harms. The FDA pressure campaign was illegal, medically dangerous, and
caused major enumerated harms. The defendants’ motion to dismiss should be denied.
Respectfully Submitted,
s/ David A. Dalia
David A. Dalia
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Case 3:22-cv-00184 Document 35-1 Filed on 10/06/22 in TXSD Page 19 of 21
David A. Dalia
Attorney at Law, La. Bar No. 01320
830 Union Street, Suite 302
New Orleans, LA 70112
T: 504-524-5541
davidadalia@gmail.com
Pro hac vice
Lauren E. Bradford
Attorney at Law
1645 W. Valencia Road, Ste 109 #19
Tucson, AZ 85746-6099
Laurenbradford@aflds.org
Counsel for Amicus Curiae,
America’s Frontline Doctors
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Case 3:22-cv-00184 Document 35-1 Filed on 10/06/22 in TXSD Page 20 of 21
Certificate of Compliance
I hereby certify that the foregoing amicus curiae brief contains 3255 words
as measured by Microsoft Word, and that its page length is no more than fourteen
(14) pages. I further certify that this motion is in 14-point Times New Roman type.
s/ David A. Dalia
David A. Dalia
Certificate of Service
I hereby certify that on the 6th day of October, 2022, a copy of the foregoing
Consent Motion was filed electronically with the Clerk of Court using the
CM/ECF system, and notice of this filing was sent electronically to all counsel of
record using the CM/ECF system.
s/ David A. Dalia
David A. Dalia
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