Complaint — AAPS v. FDA

Record facts

Full text

1 
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 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 1 filed 06/02/20   PageID.1   Page 1 of 24

2 
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-and-
policy-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). 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 1 filed 06/02/20   PageID.2   Page 2 of 24

3 
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 non-
hospitalized 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 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 1 filed 06/02/20   PageID.3   Page 3 of 24

4 
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. 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 1 filed 06/02/20   PageID.4   Page 4 of 24

5 
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]”). 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 1 filed 06/02/20   PageID.5   Page 5 of 24

6 
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. § 360bbb-
3(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.  
Case 1:20-cv-00493-RJJ-SJB   ECF No. 1 filed 06/02/20   PageID.6   Page 6 of 24

7 
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: 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 1 filed 06/02/20   PageID.7   Page 7 of 24

8 
[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 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 1 filed 06/02/20   PageID.8   Page 8 of 24

9 
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). 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 1 filed 06/02/20   PageID.9   Page 9 of 24

10 
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). 
ͶͶǤ 
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 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 1 filed 06/02/20   PageID.10   Page 10 of 24

11 
[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). 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 1 filed 06/02/20   PageID.11   Page 11 of 24

12 
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-around-
hydroxychloroquine-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-coronavirus-
hydroxychloroquine-intl/index.html (viewed 5/31/20). 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 1 filed 06/02/20   PageID.12   Page 12 of 24

13 
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-america-
federative-republic-brazil-regarding-health-cooperation/ (viewed 6/1/2020). 
14 
https://www.techtimes.com/articles/249779/20200520/hiv-scientist-doubts-coronavirus-
vaccine-claims-social-distancing-is-better-to-fight-covid-19.htm (viewed 5/31/20). 
15 See footnote 2, supra. 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 1 filed 06/02/20   PageID.13   Page 13 of 24

14 
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 non-
recused 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-woodcock-
steps-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). 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 1 filed 06/02/20   PageID.14   Page 14 of 24

15 
& 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 § 360bbb-
3(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. § 360bbb-
3(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. 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 1 filed 06/02/20   PageID.15   Page 15 of 24

16 
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 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 1 filed 06/02/20   PageID.16   Page 16 of 24

17 
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 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 1 filed 06/02/20   PageID.17   Page 17 of 24

18 
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-re-
prescriptions/ (viewed 5/31/20). 
22  
http://www.fsmb.org/siteassets/advocacy/pdf/fsmb-nabp-joint-statement-covid-19-
prescribing-fsmb-edits.pdf (emphasis added, viewed 5/31/20). 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 1 filed 06/02/20   PageID.18   Page 18 of 24

19 
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. 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 1 filed 06/02/20   PageID.19   Page 19 of 24

20 
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). 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 1 filed 06/02/20   PageID.20   Page 20 of 24

21 
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 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 1 filed 06/02/20   PageID.21   Page 21 of 24

22 
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. 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 1 filed 06/02/20   PageID.22   Page 22 of 24

23 
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 non-
availability 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 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 1 filed 06/02/20   PageID.23   Page 23 of 24

24
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,
Andrew L. Schlafly
General Counsel
Association of American Physicians & Surgeons
939 Old Chester Rd.
Far Hills, NJ 07931
Tel: 908-719-8608
Fax: 908-934-9207
Email: aschlafly@aol.com
____________________________________
Lawrence J. Joseph, DC Bar No. 464777
Law Office of Lawrence J. Joseph
1250 Connecticut Ave, NW, Suite 700-1A
Washington, DC 20036
Tel: 202-355-9452
Fax: 202-318-2254
Email: ljoseph@larryjoseph.com
Counsel for Plaintiff
/s/ Lawrence J. Joseph
Case 1:20-cv-00493-RJJ-SJB   ECF No. 1 filed 06/02/20   PageID.24   Page 24 of 24

File and source

File

gov.uscourts.miwd.97901.1.0.pdf

Size

364,878 bytes

SHA-256

79d4e7126ef8c589b85a8df113a8922dd38d4f3c0f4f9c85e8b29d75597c4e48

Our copy

gov.uscourts.miwd.97901.1.0.pdf

Original

archive.org