Association of American Physicians & Surgeons v. Food & Drug Administration et al

Filing 1

COMPLAINT for declaratory and injunctive relief against all defendants filed by Association of American Physicians & Surgeons (Joseph, Lawrence) Modified text on 6/4/2020 (pjw).

IN THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF MICHIGAN
ASSOCIATION OF AMERICAN
PHYSICIANS & SURGEONS,

)
)
)
Plaintiff,
)
)
v.
)
)
FOOD & DRUG ADMINISTRATION; DR.
)
STEPHEN M. HAHN, Commissioner of Food &
)
Drugs, in his official capacity; BIOMEDICAL
)
ADVANCED RESEARCH & DEVELOPMENT
)
AUTHORITY; GARY L. DISBROW, Ph.D.,
Acting Director, Biomedical Advanced Research & )
)
Development Authority, in his official capacity;
)
DEPARTMENT OF HEALTH & HUMAN
)
SERVICES; and ALEX AZAR, Secretary of
Health & Human Services, in his official capacity, )
)
Defendants.
)

No. 1:20-cv-0493

COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF
The Association of American Physicians & Surgeons (“AAPS” or “Plaintiff”) seeks
declaratory and injunctive relief against the federal Department of Health & Human Services
(“HHS”), two of its constituent agencies – the Food and Drug Administration (“FDA”) and the
Biomedical Advanced Research & Development Authority (“BARDA”) – and their respective
lead officers (collectively, “Defendants”), based on the following allegations.
NATURE OF THE ACTION
1.

AAPS brings this action on behalf of its members and their patients to end the

irrational interference by the FDA with timely access to hydroxychloroquine (“HCQ”), which has
been donated in large quantities to the federal government for prompt distribution. Specifically,
AAPS seeks an injunction against the FDA’s Emergency Use Authorization dated March 28, 2020
(“EUA”), which prohibits use of the donated HCQ except for already-hospitalized patients for

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whom clinical trials are unavailable.
2.

Through a biased, unlawful process described in greater detail below, FDA officials

from prior administrations acted contrary to the wishes of President Donald Trump, by arbitrarily
limiting use of HCQ from the Strategic National Stockpile (SNS) “to prescribe to adolescent and
adult patients hospitalized with COVID-19, as appropriate, when a clinical trial is not available or
feasible.”1
3.

Specifically, a Barack Obama-appointed official who is outspokenly critical of

President Trump, Rick Bright, personally opposed making HCQ widely available to the public
from the federal SNS,2 and distorted the agency process to arbitrarily and unjustifiably limit access
by patients to HCQ received as donations by the federal government for the purpose of making it
available promptly to the public.
4.

HCQ has been approved as safe by the FDA for sixty-five (65) years,3 and is safer

than numerous medications that are widely available over the counter (“OTC”) without requiring
a prescription, including anti-depressants (St John’s Wort), sleeping pills (diphenhydramine),
bronchodilators (ephedrine), many pain medications including ibuprofen, acetaminophen
(Tylenol®), and even aspirin. HCQ is not addictive in any way.
5.

President Donald Trump himself has repeatedly praised HCQ, and he announced

on May 18, 2020 that on his own initiative and with his physician’s advice and prescription, Trump

1

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-andpolicy-framework/emergency-use-authorization#covidtherapeutics (viewed 5/31/20).
2

https://www.statnews.com/2020/04/24/why-rick-bright-involved-hydroxychloroquine/
(viewed 5/31/20).
3

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process
&rptName=1&reportSelectMonth=4&reportSelectYear=1955&nav (viewed 5/31/20).

2

took a full regimen of HCQ himself as a prophylaxis against COVID-19, as other world leaders
have reportedly been doing.
6.

The arbitrary, irrational, and unjustifiable interference by Defendants with the use

of HCQ as a prophylaxis interferes with the political process by which the United States selects its
president: national political conventions. For nearly two centuries, thousands of delegates attend a
national political convention together to nominate their candidate for president and to present their
slate to the American public. Continued, irrational interference by Defendants with a safe
prophylaxis for COVID-19 has the effect of infringing on the right of the people to hold national
political conventions, which have been an essential part of our presidential elections since at least
1832.
7.

Efforts to persuade the FDA to remove its irrational limitations of hospitalization

and non-availability of a clinical trial have been unsuccessful and petitioning the FDA amid the
conflicts of interests among its officials would be futile on this issue.
8.

These arbitrary, irrational, and unjustifiable limitations by the FDA in its EUA

prevents the use of HCQ as a prophylaxis in nursing homes and when in the best interests of nonhospitalized patients.
9.

HCQ, like most medications, loses its efficacy over time, particularly at warmer

temperatures which are occurring now as summer approaches. Most of the HCQ doses in the SNS
will be discarded for their loss in efficacy if the FDA restrictions on its use are not promptly lifted.
10.

There will be irreparable, immediate harm to AAPS members and their patients if

the arbitrary, irrational, and unjustifiable restrictions by FDA on use of HCQ from the SNS are not
enjoined and declared invalid immediately.
PARTIES
11.

Plaintiff AAPS was founded in 1943 and is a nonprofit membership organization

3

of physicians in virtually all specialties. AAPS is incorporated under the laws of Indiana and
headquartered at 1601 N. Tucson Blvd., Suite 9, in Tucson, Arizona. AAPS membership includes
physicians practicing in this Western District of Michigan. Members of AAPS, including at least
one in this district, have been and continue to be harmed irreparably by the FDA’s restrictions in
its EUA.
12.

Defendant HHS is a federal executive agency, and defendants FDA and BARDA

are constituent agencies within HHS.
13.

Defendant Stephen M. Hahn is the Commissioner of Food & Drugs, who is the lead

officer within the FDA.
14.

Defendant Gary L. Disbrow is BARDA’s Acting Director, who is the lead officer

within BARDA.
15.

Defendant Alex Azar is the Secretary of Health & Human Services, who is the lead

officer within HHS.
JURISDICTION AND VENUE
16.

This action arises out of Defendants’ ongoing violations of the equal protection

component of the Due Process Clause, U.S. CONST. amend. V, cl. 4, Section 564 of the Federal
Food, Drug and Cosmetic Act (“FFDCA”), 21 U.S.C. § 360bbb-3, and the Administrative
Procedure Act (“APA”), 5 U.S.C. §§ 701-706, and thus raises federal questions over which this
Court has jurisdiction pursuant to 28 U.S.C. § 1331.
17.

Venue is proper in this United States District Court for the Western District of

Michigan, under 28 U.S.C. § 1391(e)(1), because Defendant FDA resides in this district by virtue
of having an office at 410 W. Michigan Ave, Kalamazoo, Michigan 49007, and Plaintiff has at
least one member here who has been injured by virtue of Defendants’ actions at issue. If necessary
for venue, Plaintiff’s members could become named plaintiffs.

4

18.

An actual and justiciable controversy exists between Plaintiffs and Defendants.

19.

As set forth in more detail below, members of Plaintiff AAPS have suffered injury

in the form of the denial by the FDA of access to HCQ for AAPS members to prescribe to patients.
This causes economic injury to AAPS members by interfering with their ability to care for patients
who have COVID-19 or who are at risk for it.
20.

Because this Court has jurisdiction as a threshold matter, the Declaratory Judgment

Act, 28 U.S.C. §§ 2201-2202, provides this Court the power to “declare the rights and other legal
relations of any interested party …, whether or not further relief is or could be sought.” 28 U.S.C.
§ 2201; accord FED. R. CIV. P. 57 advisory committee note (“the fact that another remedy would
be equally effective affords no ground for declining declaratory relief”).
CONSTITUTIONAL AND STATUTORY BACKGROUND
21.

The Due Process Clause of the Fifth Amendment includes an equal-protection

component that is coextensive with the equal-protection guarantees of the Equal Protection Clause
of the Fourteenth Amendment.
22.

At a minimum, under those equal protection guarantees, the government cannot

treat similarly situated groups or persons differently without a rational basis for doing so.
23.

Upon finding an equal-protection violation, a reviewing court’s remedy can “level

up” the disparate treatment of the disfavored class (e.g., provide greater access to HCQ).
24.

Congress enacted the Pure Food and Drugs Act, ch. 3915, 34 Stat. 768 (1906),

under its Commerce Power. In 1938, Congress amended and replaced that Act with the FFDCA.
PUB. L. NO. 75 -717, 52 Stat. 1040 (1938) (codified, as amended, at 21 U.S.C. §§ 301-399i).
25.

In enacting the FFDCA, Congress was clear that the FFDCA does not define the

practice of medicine. See S. REP. NO. 74-361, at 3 (1935) (FFDCA is “not intended as a medical
practices act and [would] not interfere with the practice of the healing art[s]”).

5

26.

FDA has expressly recognized the freedom that health care professionals possess

to use and prescribe approved drugs off-label: “[O]nce a [drug] product has been approved for
marketing, a physician may prescribe it for uses or in treatment regimens of patient populations
that are not included in approved labeling.” 59 Fed. Reg. 59, 820, 59, 821-22 (Nov. 18, 1994)
(internal quotation marks omitted, alterations in original).
27.

Health care professionals may lawfully prescribe or use an FDA-approved drug

both for any uses suggested on the labeling itself (i.e., “on-label uses”) and in ways that are not
prescribed, recommended, or suggested on the FDA-approved labeling (i.e., “off-label uses”).
28.

Off-label use of prescription drugs accounts for roughly 20% of all prescriptions,

and in some medical specialties it accounts for a majority of prescriptions. Many off-label uses
have become the standard of medical care.4 For generic medication such as HCQ, on which any
patent rights have long since expired, there is no financial incentive for any entity to fund
expensive studies to seek approval by the FDA for off-label uses, and such approval is not
customarily sought or granted.
29.

Section 4(a) of the Project Bioshield Act of 2004, PUB. L. NO. 108-276, §4(a), 118

Stat. 835, 853-859, added Section 564 to the FFDCA, codified as 21 U.S.C. § 360bbb-3. Under
that section, the Secretary of HHS can authorize the emergency use of either or both unapproved
medical products and/or unapproved uses of approved medical products, 21 U.S.C. § 360bbb3(a)(1)-(4), upon recognizing or declaring an emergency under the criteria outlined in 21 U.S.C.
§ 360bbb-3(b)(1)(A)-(D).
30.

In such an emergency, the statutory criteria for granting an emergency use

4

David C. Radley; Stan N. Finkelstein; Randall S. Stafford (2006). “Off-label Prescribing Among
Office-Based Physicians”. Archives of Internal Medicine. 166 (9): 1021–1026.

6

application are that the Secretary of HHS concludes the following:
(1) that an agent referred to in a declaration under subsection (b) can cause
a serious or life-threatening disease or condition;
(2) that, based on the totality of scientific evidence available to the
Secretary, including data from adequate and well-controlled clinical trials,
if available, it is reasonable to believe that—
(A) the product may be effective in diagnosing, treating, or
preventing—
(i) such disease or condition; or
(ii) a serious or life-threatening disease or condition caused
by a product authorized under this section, approved or
cleared under this chapter, or licensed under section 351 of
the Public Health Service Act [42 U.S.C. 262], for
diagnosing, treating, or preventing such a disease or
condition caused by such an agent; and
(B) the known and potential benefits of the product, when used to
diagnose, prevent, or treat such disease or condition, outweigh the
known and potential risks of the product, taking into consideration
the material threat posed by the agent or agents identified in a
declaration under subsection (b)(1)(D), if applicable;
(3) that there is no adequate, approved, and available alternative to the
product for diagnosing, preventing, or treating such disease or condition;
(4) in the case of a determination described in subsection (b)(1)(B)(ii), that
the request for emergency use is made by the Secretary of Defense; and
(5) that such other criteria as the Secretary may by regulation prescribe are
satisfied.
21 U.S.C. § 360bbb-3(c)(1)-(5).
31.

Neither FDA nor HHS nor any other federal agency has promulgated a regulation

pursuant to 21 U.S.C. § 360bbb-3(c)(5) to establish criteria that Defendants may consider in
granting an EUA under 21 U.S.C. § 360bbb-3(c).
32.

Section 1557 of the Affordable Care Act prohibits discrimination in health

programs and activities by not only recipients of federal funds but also federal agencies:

7

[A]n individual shall not, on the ground prohibited under title VI of the Civil
Rights Act of 1964 …, the Age Discrimination Act of 1975 …, or section
504 of the Rehabilitation Act of 1973 …, be excluded from participation in,
be denied the benefits of, or be subjected to discrimination under, any health
program or activity, any part of which is receiving Federal financial
assistance, including credits, subsidies, or contracts of insurance, or under
any program or activity that is administered by an Executive Agency or any
entity established under this title[.]
42 U.S.C. § 18116(a).
33.

The entity Defendants – HHS, FDA, and BARDA – are “Executive Agencies”

within the meaning of Section 1557 of the Affordable Care Act, and the SNS is a “health program
or activity” within the meaning of that section.
34.

As relevant here, the judicial-review provisions of the APA proscribe agency action

that is “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” 5
U.S.C. § 706(2)(A). The APA further bars agency action that is “in excess of statutory jurisdiction,
authority, or limitations,” Id. at § 706(2)(C), and directs courts to “hold unlawful and set aside
agency action, findings, and conclusions found to be … contrary to constitutional right, power,
privilege or immunity.” 5 U.S.C. § 706(2)(B).
ALLEGATIONS RELEVANT TO ALL COUNTS
35.

COVID-19 has reportedly caused the death of more than 100,000 Americans in

merely a few months this year, roughly half of whom have contracted and died from this disease
while residing in nursing homes.
36.

By denying elderly nursing-home patients access to HCQ when COVID-19 affects

those patients more severely than younger patients, the EUA disparately impacts the elderly and
thus discriminates on the basis of age within the meaning of Section 1557 of the Affordable Care
Act, 42 U.S.C. § 18116, and the Age Discrimination Act of 1975.
37.

By the end of May 2020, pharmaceutical companies donated more than 150 million

8

doses of hydroxychloroquine (HCQ) – enough to fully treat more than 15 million people – to the
federal government for immediate use in treating COVID-19, and as part of their efforts for the
“prevention and treatment of the coronavirus outbreak.”5
38.

Yet the vast majority of these 150 million doses of HCQ have not been distributed

to the public and are in imminent danger of spoilage due to the passage of time amid the increasing
temperatures as summer approaches.
39.

Multiple foreign governments, including China, India,6 South Korea, Costa Rica,

United Arab Emirates, and Turkey, successfully recommend use of HCQ for effective early
treatment of COVID-19, and for use as a prophylaxis for the disease. Multiple studies confirm the
effectiveness of HCQ as an early treatment of COVID-19.
40.

For example, a recent study in India, where HCQ is being widely used as a

prophylaxis, concluded that:
The pivotal finding of our study was the noteworthy benefits of HCQ prophylaxis. … [T]he
National Task Force for COVID-19 in India recommended once a week maintenance dose
for seven weeks (400 mg once weekly), following the loading dose (400 mg bd).7
41.

There are no peer-reviewed or meritorious studies showing a lack of HCQ safety

for COVID-19 patients. The retrospective studies cited in the media to the contrary are too flawed
to inform rational decisionmaking because they compare outcomes without involving like patient
populations (e.g., the HCQ patients may have been more sick than the non-HCQ patients or may
have come from geographic areas with more acute exposures, which would explain higher rates of
negative outcomes without showing in any way that HCQ caused or contributed to those

5

https://phrma.org/en/Coronavirus/PhRMA-Member-Efforts (viewed 5/31/20).

6

https://theprint.in/health/hcq-breakthro...se/427583/ (viewed 5/31/20).

7

http://www.ijmr.org.in/temp/IndianJMedRes000-5386406_145744.pdf (p. 6, viewed 6/2/20).

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outcomes).
42.

There is dramatic difference in saving lives in countries allowing early and

prophylactic use of hydroxychloroquine compared with the United States, as of the third week in
May 2020:

43.

As explained by experts in a recent article published by the New York Times:

Acting before or very soon after an infection is the best way to handle most
acute viral diseases. Why aren’t we focusing on that with Covid-19? …
[W]e believe that trials of prophylactic and therapeutic drugs for
asymptomatic and mild cases of Covid-19 have a greater chance of success
than does administering drugs to critically ill patients — as well as greater
long-term potential to benefit more people overall.
Richard Malley and Marc Lipsitch, “Acting before or very soon after an infection is the best way
to handle most acute viral diseases. Why aren’t we focusing on that with Covid-19?” New York
Times (May 23, 2020).
An eminent Professor of Epidemiology in the Department of Epidemiology and
Public Health at the Yale School of Public Health and Yale School of Medicine, Harvey A. Risch,
stated likewise in a peer-reviewed medical journal:
An outpatient treatment that prevents hospitalization is desperately needed

10

[for COVID-19]. … Hydroxychloroquine+azithromycin has been widely
misrepresented in both clinical reports and public media …. Evidence about
use of hydroxychloroquine alone, or of hydroxychloroquine+azithromycin
in inpatients, is irrelevant concerning efficacy of the pair in early high-risk
outpatient disease. Five studies, including two controlled clinical trials,
have demonstrated significant major outpatient treatment efficacy.
Hydroxychloroquine+azithromycin has been used as standard-of-care in
more than 300,000 older adults with multicomorbidities, with estimated
proportion diagnosed with cardiac arrhythmias attributable to the
medications 47/100,000 users, of which estimated mortality is <20%,
9/100,000 users, compared to the 10,000 Americans now dying each week.
These medications need to be widely available and promoted immediately
for physicians.
Harvey A Risch, Early Outpatient Treatment of Symptomatic, High-Risk Covid-19 Patients That
Should Be Ramped-Up Immediately as Key to the Pandemic Crisis, __ AM. J. EPIDEMIOLOGY ___
(May 27, 2020) (forthcoming 2020) (emphasis added).8
45.

The BBC reported on the success of Turkey in keeping its mortality low from

COVID-19:
Chief doctor Nurettin Yiyit … says it’s key to use hydroxychloroquine
early. “Other countries are using this drug too late,” he says, “especially the
United States. We only use it at the beginning. We have no hesitation about
this drug. We believe it’s effective because we get the results.”
Orla Guerin, Coronavirus: How Turkey took control of Covid-19 emergency, BBC News (May 29,
2020).9
46.

National Public Radio recently quoted the expert Dr. Jon Giles, an epidemiologist

and rheumatologist at Columbia University Department of Medicine, about the safety of HCQ:
“It’s a very, very safe drug; it’s been used for over 75 years. When I give
someone hydroxychloroquine, I don’t get an ECG or do blood

8

https://academic.oup.com/aje/advance-article/doi/10.1093/aje/kwaa093/5847586 (viewed
6/1/20).
9

https://www.bbc.com/news/world-europe-52831017# (viewed 5/31/20).

11

monitoring.”10
47.

More than 25 articles since 1982 published in peer-reviewed medical journals have

reported on the safety of HCQ, and these articles are included in the PubMed database as
maintained by the United States National Library of Medicine at the National Institutes of Health.
48.

The Centers for Disease Control and Prevention (“CDC”), which is a division

within Defendant HHS, declares the safety of HCQ in one of its publications posted on its website:
How long is it safe to use hydroxychloroquine?
CDC has no limits on the use of hydroxychloroquine for the prevention of
malaria. When hydroxychloroquine is used at higher doses for many years,
a rare eye condition called retinopathy has occurred. People who take
hydroxychloroquine for more than five years should get regular eye
exams.11
49.

The President of El Salvador, Nayib Bukele, announced that he is taking

hydroxychloroquine as a prophylaxis against COVID-19, and that most world leaders were doing
likewise: “I use it as a prophylaxis. President Trump uses it as a prophylaxis. Most of the world’s
leaders use it as a prophylaxis,” said President Bukele.12
50.

On May 31, 2020, the United States and Brazil issued a joint statement regarding

health cooperation, which is posted on the White House’s website and provides in part the
following:
The American and Brazilian people stand in solidarity in the fight against
the coronavirus. Today, as a demonstration of that solidarity, we are
announcing the United States Government has delivered two million doses
10

https://www.npr.org/sections/health-shots/2020/05/21/859851682/politics-aroundhydroxychloroquine-hamper-science (viewed 5/31/20).
11

https://www.cdc.gov/malaria/resources/pdf/fsp/drugs/Hydroxychloroquine.pdf (p. 2, viewed
6/1/20).
12

https://www.cnn.com/2020/05/27/americas/salvador-president-coronavirushydroxychloroquine-intl/index.html (viewed 5/31/20).

12

of hydroxychloroquine (HCQ) to the people of Brazil. ...
HCQ will be used as a prophylactic to help defend Brazil’s nurses, doctors,
and healthcare professionals against the virus. It will also be used as a
therapeutic to treat Brazilians who become infected.13
Disregard of President Trump’s Policy by Agency Officials
51.

Rick Bright, Ph.D., an outspoken critic of President Trump, was the Director at

BARDA as appointed by prior President Barack Obama.
52.

Bright strongly favors vaccination for COVID-19, even though no such vaccine is

available, and some experts doubt the feasibility of developing a timely vaccine for this novel
virus.14
53.

At all relevant times Bright has opposed making HCQ widely available for

physicians to prescribe to patients in connection with COVID-19.15
54.

According to a whistleblower complaint against the Trump Administration

submitted by Bright, FDA Director of the Center for Drug Evaluation and Research Janet
Woodcock also played a pivotal role in pushing for the EUA.
55.

Woodcock also occupied a top position in a public-private operation designed to

approve new vaccines for COVID-19, and she reportedly communicated with a Wall Street analyst
concerning such development.
56.

Prophylactic use of HCQ is a rival approach to vaccination, but Woodcock did not

recuse herself from the decision-making at the FDA concerning the EUA restrictions on access to

13

https://www.whitehouse.gov/briefings-statements/joint-statement-united-states-americafederative-republic-brazil-regarding-health-cooperation/ (viewed 6/1/2020).
14

https://www.techtimes.com/articles/249779/20200520/hiv-scientist-doubts-coronavirusvaccine-claims-social-distancing-is-better-to-fight-covid-19.htm (viewed 5/31/20).
15

See footnote 2, supra.

13

HCQ.
57.

After an advocacy group objected to a conflict of interest by Woodcock in her

various roles, she recused herself from the review process for vaccination16 but remains nonrecused from decision-making that sharply and unjustifiably limits access to HCQ.
58.

Bright and agency officials working with him have been biased by their opposition

to President Trump and/or their support of rival treatments other than HCQ, such as remdesivir as
advocated by Bright and vaccination as sought by Woodcock.
59.

Specifically, Bright favors an expensive, proprietary antiviral medication

developed by Gilead Sciences (“Gilead”). Bright formed the following pre-conceived opinion in
favor of Gilead which should have caused his recusal from the decision-making process about
HCQ:
Gilead’s supply of the drug [i.e., remdesivir] was low – it had only a few
thousand doses of the drug on hand and the timeline to manufacture more
was lengthy. [Bright] repeatedly advised Dr. Kadlec and other HHS
officials of the urgent need to acquire the existing doses and to secure
future doses as they were produced. He also strongly recommended that
HHS work with Gilead to “on-shore” all steps of the Remdesivir supply
chain to ensure an uninterrupted supply in the United States.17
60.

At the improper insistence of Bright, before he was relieved of his HCQ-related

duties by the Trump Administration, on March 28, 2020 the FDA arbitrarily limited use of HCQ
from the SNS as follows.
The EUA
61.

The FDA issued its EUA as a Letter from Denise M. Hinton, Chief Scientist, Food

16

https://endpts.com/covid-19-roundup-hit-with-new-conflict-accusations-janet-woodcocksteps-out-of-the-agencys-covid-19-chain-of-command/ (viewed 5/31/20).
17

https://www.kmblegal.com/sites/default/files/NEW R. Bright OSC
Complaint_Redacted.pdf (emphasis added, viewed 5/31/20).

14

& Drug Admin., to Rick Bright, Ph.D., Director, Biomedical Advanced Research & Development
Authority, Request for Emergency Use Authorization For Use of Chloroquine Phosphate or
Hydroxychloroquine Sulfate Supplied From the Strategic National Stockpile for Treatment of
2019 Coronavirus Disease (Mar. 28, 2020). The disputed portion of the EUA are the
hospitalization and clinical-trial restrictions in its “Scope of Authorization” as follows:
The hydroxychloroquine sulfate may only be used to treat adult and
adolescent patients who weigh 50 kg or more hospitalized with COVID-19
for whom a clinical trial is not available, or participation is not feasible.
EUA, at 4 (emphasis added).18
62.

These restrictions deny patients the use of HCQ for its prophylactic effect (i.e., the

“with COVID-19” limit requires that the patient have COVID-19), deny non-hospitalized patients
(such as nursing home residents and patients who visit physicians’ offices) access to HCQ, and
even deny or restrict access to hospitalized patients for whom clinical trials are available.
63.

In the EUA, Defendants state that the criteria for an EUA are met with respect to

the existence of an emergency for the COVID-19 pandemic under 21 U.S.C. § 360bbb-3(b), that
the COVID-19 virus can cause serious or life-threatening diseases or conditions under § 360bbb3(c)(1), that HCQ is or may be effective in treating or preventing the COVID-19 virus under
§ 360bbb-3(c)(2)(A)(i), and that there is no adequate, approved, and available alternative to HCQ
under § 360bbb-3(c)(3).19
64.

Neither the EUA itself nor Defendants invoked the scarcity of HCQ as a basis for

rationing access to HCQ. Nor could they, given the plentiful supply of the easy-to-manufacture

18

See footnote 1, supra.

19

The Secretary of Defense did not request the EUA; as such, the criteria of 21 U.S.C. § 360bbb3(c)(4) are not germane to the challenged EUA. Defendants have not promulgated additional
regulatory criteria pursuant to 21 U.S.C. § 360bbb-3(c)(5), and thus it adds no additional criteria
for the issuance of an EUA.
15

HCQ which has limited shelf life in the SNS amid warming temperatures.
65.

The EUA-related criterion in dispute is whether the limitations in the EUA’s

“Scope of Authorization” is necessary under § 360bbb-3(c)(2)(A) with respect to patients who are
not “hospitalized with COVID-19 for whom a clinical trial is not available, or participation is not
feasible.” Defendants give two rationales for these restrictions in the EUA: (1) “The safety profile
of these drugs has only been studied for FDA approved indications, not COVID-19;” and (2) “FDA
encourages the conduct and participation in randomized controlled clinical trials that may produce
evidence concerning the effectiveness of these products in treating COVID-19.” EUA, at 2.
66.

Defendants’ first rationale is a strawman, because safety is determined with respect

to patients, not diseases. HCQ has been proven to be safe for 65 years and has been fully approved
by the FDA as safe throughout this entire period.
67.

The EUA misleads the public with its first rationale by falsely pretending that a

medication approved as safe for treating one disease can somehow not be safe for treating another
disease.
68.

The EUA further misleads the public with its first rationale by falsely implying that

medication approved as safe for one use requires time-consuming additional studies of safety
before it may properly be used to treat a new disease.
69.

In fact, the “safety profile” with respect to new uses of a medication previously

approved by the FDA is virtually never studied, and there is no rational basis for delaying new
uses of previously approved medication by requiring such studies.
70.

With respect to patients with COVID-19 who are not hospitalized, the FFDCA, the

Constitution’s federalist structure, and the presumption against preemption all suggest that
Congress did not intend Defendants to supersede a prescribing medical professional’s judgment

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for off-label uses of FDA-approved drugs for patients.
71.

With respect to patients not infected with COVID-19 for whom HCQ is prescribed

or sought for HCQ’s prophylactic effect, EUA’s stated safety concern about HCQ’s effect on
patients infected with COVID-19 does not apply to patients not infected with COVID-19.
72.

With respect to the EUA’s seeking to push patients into clinical trials in lieu of

having their medical professional prescribe the drug, Defendants lack the authority to limit access
that way. Significantly, not everyone who participates in a “randomized controlled clinical trial”
even receives the drug in question, as usually half of participants in a clinical trial receive a placebo
and thus would not receive any HCQ.
73.

The EUA discriminates against everyone who is outside of a hospital: residents of

nursing homes, physicians who care for nursing home patients, physicians having office practices,
and patients who are treated in connection with office visits.
74.

The EUA also discriminates against those who would receive only a placebo, and

not HCQ, in a clinical study arbitrarily required by the EUA.
75.

The discrimination against these millions of people threatens to cause the

unnecessary loss of life and unnecessary illness and thereby injures AAPS members and their
patients.
76.

Multiple studies suggest that HCQ is more effective if used early in the progression

of COVID-19, as other antiviral medication like oseltamivir (Tamiflu®) is, and the blanket federal
limitations in the EUA are arbitrary, irrational, and unjustified in interfering with early treatment
by HCQ.
77.

There is no need to ration or restrict access to HCQ, as the stockpile contains

enough to serve 15 million Americans and it is feasible for manufacturers to produce a million

17

new doses of HCQ daily.
78.

These arbitrary, irrational, and unjustifiable limitations by the FDA prevent the use

of HCQ as a prophylaxis, as President Trump and other world leaders are using it, and prevent
nursing home residents from receiving it, where more than half of the COVID-19 mortalities have
reportedly occurred.20
79.

Never

before

in

the

history

of

the

United

States

has

an

“emergency use authorization” been issued to restrict the use of an old and safe medication, as
Defendants have improperly done with respect to HCQ. The EUA restrictions on the use of the
long-approved medications is outside the scope of any statutory authorization.
80.

As is customary, state regulatory officials have imitated or relied upon the

unjustified FDA policy,21 as commanded by the Federation of State Medical Boards (“FSMB”).
81.

The FSMB – which directs state medical boards that wield complete authority over

licenses to practice medicine – relied on the EUA to order that:
Physicians, nurses, pharmacists, pharmacies and hospitals have an ethical
duty to put the needs of patients first, and this includes observing strict
prescribing guidelines. On March 28, the Food and Drug Administration
(FDA) issued an Emergency Use Authorization (EUA) for use of oral
formulations of chloroquine phosphate and hydroxychloroquine sulfate.
The authorization allows these medications to be prescribed by clinicians
for hospitalized adult and adolescent patients “for whom a clinical trial is
not available, or participation is not feasible.” Clinicians should avoid
prescribing for themselves or their family members and should be aware
that deviating from the standard of care could put their license at risk.22

20

https://www.theguardian.com/us-news/2020/may/11/nursing-homes-us-data-coronavirus
(viewed 5/31/20).
21

https://www.lawyersinlafayette.com/2020/04/covid-19-warning-from-medical-board-represcriptions/ (viewed 5/31/20).
22

http://www.fsmb.org/siteassets/advocacy/pdf/fsmb-nabp-joint-statement-covid-19prescribing-fsmb-edits.pdf (emphasis added, viewed 5/31/20).

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Ripeness
82.

The EUA is “final agency action for which there is no other adequate remedy.” 5

U.S.C. § 704. The EUA represents FDA’s consummated decision-making process to grant Bright’s
request with his limitations. Further, the EUA was a decision from which rights or obligations
were determined and from which legal consequences (e.g., access to HCQ from the SNS) flowed.
83.

Plaintiff has no adequate or available administrative remedy; in the alternative, any

effort to obtain an administrative remedy would be futile.
84.

Plaintiff has no adequate remedy at law.
Injury to AAPS Members

85.

Defendant FDA’s unlawful action has caused injury to a physician member of

Plaintiff AAPS (“Dr. John Doe”).
86.

Physician Dr. John Doe has been unable to successfully prescribe a full regimen of

HCQ for patients in need of it, due to the FDA’s unlawful and irrational EUA.
87.

Patients of Dr. John Doe have been additionally harmed by the FDA’s EUA by

being denied access to a full regimen of the potentially lifesaving HCQ.
88.

Dr. John Doe practices within the Western District of Michigan and has patients

who reside in Kalamazoo, Michigan.
89.

Another physician member of AAPS was prevented from successfully

prophylactically treating his nursing home patients with HCQ by virtue of the FDA’s EUA.
90.

Numerous physician members of AAPS, including Dr. John Doe, reasonably fear

retaliation against them by state medical boards based on the irrational restrictions in the EUA
along with their incorporation into the directive made to state medical boards by the FSMB.

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Disparate Impact of FDA Policy on Religious Services
91.

Access to a prophylaxis and early treatment of COVID-19 is particularly important

to reopening religious services without a chilling effect which denial of timely access to treatment
causes.
92.

About a quarter (25%) of weekly attendees of all kinds of religious services are

over 65 years old,23 who are thereby at higher risk from COVID-19 than other demographic
groups, such as young and healthy adults.
93.

Clergy are often in contact with people who particularly vulnerable to contagion,

such as those suffering from other medical conditions.
94.

The withholding and denial of access to prophylactic and early treatment by HCQ

has a disparate impact on attendance at religious services, which AAPS members and their patients
have a constitutional right to attend.
95.

A lawsuit is pending in Beemer v. Whitmer, 1:20-cv-00323-PLM-PJG (W.D.

Mich.), which challenges on constitutional grounds the closure of churches in Michigan.
96.

Like arguments made in that lawsuit, those at high risk for COVID-19 (including

AAPS members) who attend church services should not be arbitrarily denied access by Defendants
to prophylactic and early treatment by HCQ.
CAUSES OF ACTION
COUNT I
(EQUAL PROTECTION)
97.

Plaintiff AAPS incorporates herein all statements and allegations contained in this

Complaint.

23

https://www.pewforum.org/religious-landscape-study/attendance-at-religious-services/ (viewed
5/31/20).

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98.

In issuing the EUA’s restrictions to limit access to HCQ to patients who are

hospitalized without feasible access to a clinical trial, Defendants violated the equal protection
guarantee implicit in the Due Process Clause of the Fifth Amendment to the U.S. Constitution.
The EUA impermissibly discriminates based on a patient’s hospitalization status, illness status,
and access to clinicals trial, without a rational basis for this discrimination.
99.

The doctrine of administrative exhaustion does not apply to constitutional

violations.
100.

With respect to patients who wish to use HCQ, and medical professionals who wish

to prescribe HCQ for its prophylactic effect to prevent becoming infected with the COVID-19
virus, the EUA’s limitation to hospitalized patients with COVID-19 lacks a rational basis for a
drug that FDA already has found to be safe.
101.

With respect to hospitalized patients with COVID-19 who have feasible access to

clinical trials, Defendants lack the authority to compel participation in randomized controlled
clinical trials that might not provide particular patients any access to HCQ at all.
102.

With respect to non-hospitalized patients with COVID-19, Defendants lack the

authority to override the discretion of a duly licensed medical professional to prescribe off-label
uses of FDA-approved drugs.
103.

The EUA’s unlawful discrimination against the elderly under Section 1557 of the

Affordable Care Act, 42 U.S.C. § 18116, per se lacks a rational basis.
104.

Inherent in the constitutional right to attend religious services is a right to equal

access to prophylactic and early treatment for a disease which may be transmitted during such
services.
105.

For the foregoing reasons, the challenged EUA violates the equal-protection

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component of the Fifth Amendment’s Due Process Clause and is contrary to the constitutional
authority of Defendants.
COUNT II
(ADMINISTRATIVE PROCEDURE ACT)
106.

Plaintiff AAPS incorporates herein all statements and allegations contained in this

Complaint.
107.

In addition to violating constitutional equal protection guarantees as alleged above

and incorporated herein, the EUA is also arbitrary and capricious and exceeds Defendants’ lawful
authority under the APA.
108.

Defendants lack authority under FFDCA Section 564 or any other provision to limit

access to a drug based on the patient’s ability to participate in a clinical trial.
109.

The decision-making underlying the EUA was tainted by bias, and thus it is

arbitrary and capricious.
110.

The EUA’s unlawful discrimination against the elderly under Section 1557 of the

Affordable Care Act, 42 U.S.C. § 18116, per se constitutes arbitrary and capricious action and
action not otherwise in accordance with the law.
111.

For the foregoing reasons, the challenged EUA is arbitrary, capricious, not

otherwise in accordance with the law, and in excess of authority granted by law.
COUNT III
(FIRST AMENDMENT ASSOCIATIVE RIGHTS)
112.

Plaintiff AAPS incorporates herein all statements and allegations contained in this

Complaint.
113.

Plaintiff AAPS’s members have First Amendment rights of association that depend

on access to safe prophylaxis medication during a pandemic, because otherwise they are prohibited
from or instructed not to gather in large groups.

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114.

Defendants have infringed on these associative rights of Plaintiff AAPS’s members

by denying them access to HCQ, which has been proven to be safe for more than 65 years.
115.

Defendants do not have a compelling or even a rational basis for impeding access

to HCQ as a potential prophylaxis for COVID-19.
116.

As a result of Defendants’ actions, AAPS has already had to cancel one of its

scheduled conferences and its annual conference is in jeopardy; the Republican National
Convention is also unnecessarily jeopardized to the detriment of members of AAPS and the entire
Nation.
117.

Defendants’ foregoing infringement on associative rights has caused, and continues

to cause, irreparable harm to Plaintiff AAPS.
PRAYER FOR RELIEF
118.

WHEREFORE, Plaintiff AAPS respectfully asks this Court to grant the following

relief:
A.

Enter judgment in favor of Plaintiff AAPS and against Defendants on all counts.

B.

Pursuant to 28 U.S.C. §§ 1331, 2201-2202, and FED. R. CIV. P. 57, issue a Declaratory
Judgment that the restrictions in the EUA that currently require being hospitalized, having
COVID-19, and facing the non-availability of a clinical trial prior to obtaining HCQ from
the SNS are invalid.

C.

Pursuant to 28 U.S.C. §§ 1331, 2201-2202, and FED. R. CIV. P. 57, issue an Injunction
providing that:
(i)

All Defendants are enjoined from enforcing the restrictions in the EUA that
currently require being hospitalized, having COVID-19, and facing the nonavailability of a clinical trial prior to obtaining HCQ from the SNS;

(ii)

All Defendants are enjoined to make available and distribute promptly, and for the

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benefit of the public holding valid prescriptions, the HCQ being stored in the SNS;
and
(iii)

All Defendants are enjoined from impeding the distribution, sale or purchase of
HCQ by adult members of the public during the COVID-19 pandemic.

D.

Pursuant to 28 U.S.C. § 2412 and any other applicable provisions of law or equity, award
Plaintiffs’ costs and reasonable attorneys’ fees.

E.

Such other relief as may be just and proper.

Dated: June 2, 2020

Respectfully submitted,

/s/ Lawrence J. Joseph
____________________________________
Andrew L. Schlafly
Lawrence J. Joseph, DC Bar No. 464777
General Counsel
Law Office of Lawrence J. Joseph
Association of American Physicians & Surgeons 1250 Connecticut Ave, NW, Suite 700-1A
939 Old Chester Rd.
Washington, DC 20036
Far Hills, NJ 07931
Tel: [phone]
Tel: [phone]
Fax: [phone]
Fax: [phone]
Email: [e-mail]
Email: [e-mail]
Counsel for Plaintiff

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