Petition for Writ of Mandamus — AAPS v. FDA

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UNITED STATES COURT OF APPEALS
FOR THE SIXTH CIRCUIT  
Deborah S. Hunt 
Clerk
100 EAST FIFTH STREET, ROOM 540 
POTTER STEWART U.S. COURTHOUSE  
CINCINNATI, OHIO 45202-3988  
Tel. (513) 564-7000 
www.ca6.uscourts.gov
  
Filed:  August 10, 2020 
Mr. Andrew L. Schlafly 
Law Office
939 Old Chester Road 
Far Hills, NJ 07931 
Re: Case No. 20-1743, In re: Assn of American Physicians
Originating Case No. : 1:20-cv-00493 
Dear Counsel, 
     The petition for writ of mandamus has been docketed as case number 20-1743 with the 
caption listed above.  If you have not already done so, you must mail a copy of the petition to the 
lower court judge and counsel for all the other parties. 
     Counsel for petitioner must file an Appearance of Counsel form and, if not admitted, apply 
for admission to the 6th Circuit Bar by August 24, 2020.  The forms are available on the court's 
website. 
     The district court judge to whom this petition refers has been served with this letter. 
  
Sincerely yours,
  
  
s/Ryan E. Orme 
Case Manager  
Direct Dial No. 513-564-7079 
cc:  Mr. Thomas Dorwin 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 20 filed 08/10/20   PageID.802   Page 1 of 11

 
Case No. _________ 
 
 
UNITED STATES COURT OF APPEALS 
FOR THE SIXTH CIRCUIT 
 
 
In re Association of American Physicians & Surgeons, 
 
Petitioner-Plaintiff 
 
 
From the United States District Court 
for the Western District of Michigan, Southern Division 
(No. 1:20-cv-00493-RJJ-SJB) 
 
 
PETITION FOR WRIT OF MANDAMUS 
 
 
Andrew L. Schlafly 
939 Old Chester Rd. 
Far Hills, NJ 07931 
908-719-8608 
908-934-9207 (fax) 
 
Attorney for Petitioner 
 
 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 20 filed 08/10/20   PageID.803   Page 2 of 11

 
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PETITION FOR WRIT OF MANDAMUS 
Petitioner Association of American Physicians & Surgeons (“AAPS”) 
hereby petitions for a writ of mandamus pursuant to the All Writs Act, 28 U.S.C. § 
1651(a), and FED. R. APP. P. 21(a), to compel the United States District Court for 
the Western District of Michigan, Southern Division, the Honorable Robert J. 
Jonker, to rule on AAPS’s pending motion for a preliminary injunction in an 
emergency matter concerning access to medication for COVID-19.  Respondents 
are the 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 (collectively, “Respondents”). The underlying 
litigation concerns Respondents’ unlawful impediments to safe, affordable 
medication for COVID-19 and thus affects the lives and comfort level of millions 
of Americans on an urgent basis amid the ongoing coronavirus pandemic.  This 
Petition seeks mandamus to compel the district court to act on AAPS’s motion for 
a preliminary injunction. 
“The All Writs Act empowers the federal courts to issue all writs necessary 
or appropriate in aid of their respective jurisdictions … and extends to the potential 
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jurisdiction of the appellate court where an appeal is not then pending but may be 
later perfected.”  FTC v. Dean Foods Co., 384 U.S. 597, 603 (1966) (interior 
quotation marks and citations omitted)  This Court has held that mandamus is 
appropriate to address “‘questions of unusual importance necessary to the 
economical and efficient administration of justice’ or ‘important issues of first 
impression.’”  John B. v. Goetz, 531 F.3d 448, 457 (6th Cir. 2008) (citation 
omitted).  In the absence of a ruling by the district court either to grant the 
preliminary injunction or to deny it to allow appeal to this Court, many Americans 
will face unnecessary death or illness because Respondents deny access to a 
potentially life-saving and health-preserving drug stockpiled for this very purpose.  
This easily satisfies the standard for mandamus relief. 
 
There has been no action by the district court in this time-sensitive case 
since it was filed on June 2, 2020 (Doc. 1 below), or since the briefing was 
completed on AAPS’s pending motion for a preliminary injunction (Doc. 8) on 
July 20 (Doc. 13), or since AAPS filed a motion for an expedited hearing or ruling 
on July 30 (Doc. 15).  In the meantime, many thousands of Americans have 
reportedly died from COVID-19 while being denied access to hydroxychloroquine 
(HCQ), despite its immense success in studies and in poorer countries that make it 
widely available. 
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Respondents have unlawfully interfered with patient access to HCQ for 
COVID-19 in three ways.  First, Respondents accepted donations of nearly 100 
million doses of HCQ to the Strategic National Stockpile for COVID-19, but have 
since refused to distribute the vast majority of that medication and instead is 
allowing it to deteriorate such that it will be wastefully discarded rather than 
helping save lives.  Second, Respondents have posted false, disparaging statements 
about HCQ, upon which other regulators have relied in blocking access to it.  
Third, Respondents imposed arbitrary restrictions on HCQ use as part of an 
Emergency Use Authorization (EUA) and, after the filing of this lawsuit, 
Respondents rescinded the EUA in a manner that improperly extended their 
wrongful restrictions and disparagement to continue to block access to HCQ for 
early treatment of COVID-19. 
 
President Donald Trump, who has repeatedly praised HCQ and successfully 
took it himself in May as a prophylaxis against HCQ, retweeted favorably about 
this pending lawsuit on July 27, which underscores the national significance of this 
litigation.  Due to the upcoming presidential election, President Trump’s support of 
HCQ has caused some of his opponents to block access to it for political reasons. 
 
On July 28, 2020, Yale School of Public Health epidemiology Professor 
Harvey Risch, M.D., stated on national television that “75,000 to 100,000 lives will 
be saved” if the stockpile of HCQ being wrongly withheld by Respondents were 
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released, as sought by AAPS in its pending motion for a preliminary injunction.  
Professor Risch observed further in frustration at the politically motivated interference 
with access to HCQ: 
It’s a political drug now, not a medical drug …. And I think we’re basically 
fighting a propaganda war against the medical facts ….1 
 
As presented to the district court in a sworn declaration in support of 
AAPS’s pending motion for a preliminary injunction, countries that are allowing 
access to HCQ to treat COVID-19 early and prophylactically are doing far better in 
conquering the disease than the wealthier United States is: 
Country 
HCQ Policy 
Percentage 
COVID-19 
Deaths Per 
Case
COVID-19 
Deaths Per 
Million in 
Population
United Kingdom HCQ is discouraged 
and mostly 
unavailable
14% 
628 
Italy 
HCQ’s value was not 
known for the many 
initial casualties
14.5% 
573 
France 
HCQ is officially 
disfavored
18.5% 
454 
United States 
FDA interferes with 
access to HCQ
5.2% 
370 
Russia 
HCQ is encouraged 
1.4% 
56 
India 
HCQ is used 
prophylactically
3.2% 
10 
 
1 https://www.myjoyonline.com/news/international/yale-epidemiologist-says-
hydroxychloroquine-could-save-up-to-100k-lives-if-used-for-coronavirus/ (viewed 
August 8, 2020). 
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Country 
HCQ Policy 
Percentage 
COVID-19 
Deaths Per 
Case
COVID-19 
Deaths Per 
Million in 
Population
Turkey 
HCQ is used as early 
treatment
2.6% 
59 
Israel 
HCQ is encouraged 
1.5% 
33 
South Korea 
HCQ is encouraged 
2.3% 
5 
 
Declaration of Jeremy Snavely dated June 22, 2020, at ¶ 28 (Exh. 2 to AAPS Mot. 
for a Preliminary Injunction, Doc. 8-4). 
 
AAPS additionally provided this information graphically to the district 
court, thereby highlighting the stark contrast between the success in defeating 
COVID-19 by countries, typically poorer, which allow HCQ access, compared 
with the wealthier, more liberal countries that have interfered with access:   
 
 
Id. at ¶ 29. 
 
As explained to the district court, a recent study of thousands of patients at 
the Henry Ford Health System in Michigan demonstrated that HCQ is both very 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 20 filed 08/10/20   PageID.808   Page 7 of 11

 
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safe and highly effective in treating COVID-19, reducing mortality by 50%.  
Henry Ford Health System, Treatment with Hydroxychloroquine Cut Death Rate 
Significantly in COVID-19 Patients, Henry Ford Health System Study Shows (July 
2, 2020).2  Dozens of additional studies further demonstrate the efficacy of HCQ as 
preventive or early treatment for the disease.3  A petition by AAPS at 
https://hcqpetition.com/ supporting Henry Ford Health System’s request to the 
FDA to allow outpatient use attracted 8,568 signatures by August 8. 
 
As also explained to the district court in support of AAPS’s pending motion 
for a preliminary injunction, there is a striking correlation between countries 
having policies which recognize the sanctity of life and those which are allowing 
access to HCQ for early and prophylactic treatment of COVID-19.  The more 
religiously affiliated countries of Poland, Israel, South Korea, Republic of the 
Philippines, Turkey, and several in South and Central America have much lower 
mortality rates from COVID-19 as they pursue the more pro-life policy of 
authorizing HCQ access.4  In contrast, nations in Western Europe having secular 
views against the sanctity of life have been more likely to block access to HCQ, 
 
2  
https://www.henryford.com/news/2020/07/hydro-treatment-study 
(viewed 
August 9, 2020). 
3  
https://c19study.com/ (a collection of 70 studies clearly showing the 
effectiveness of HCQ as an early treatment for COIVD-19, viewed August 9, 
2020). 
4 https://www.worldometers.info/coronavirus/#countries (viewed August 8, 2020).  
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and they have higher mortality rates from COVID-19.  President Trump holds and 
was elected on a pro-life position, and respect for his electoral mandate reinforces 
the need to enjoin the anti-life interference with HCQ by Respondents. 
On July 30, former presidential candidate and Trump supporter Herman 
Cain died from COVID-19, within mere weeks of contracting it, and many 
hundreds or thousands of other Americans are tragically dying daily from this 
disease in the absence of access to early, effective treatment.  The beloved Herman 
Cain died in Georgia5 which, in reliance on false anti-HCQ statements and 
arbitrary actions by Respondents, generally denies access to HCQ.6  Ironically, like 
President Trump, Cain himself had repeatedly advocated in favor of access to this 
potentially life-saving medication.7 
Even Democratic politicians have praised HCQ for saving their lives, despite 
the implicit credit that provides to Trump.  On August 8, the New York Post quoted 
Democratic Queens Councilman Paul Vallone as saying that HCQ “saved my life” 
 
5 
https://www.cnbc.com/2020/08/04/herman-cain-was-on-a-ventilator-before-he-
died-from-covid-19-top-aide-says.html (viewed August 9, 2020). 
6 
https://gbp.georgia.gov/document/document/rule480-10-038-
22medicationlimitationseffective032720pdf/download  
https://gbp.georgia.gov/press-releases/2020-04-08/covid-19-coronavirus-response-
georgia-board-pharmacy (both viewed August 9, 2020). 
7 
https://heavy.com/news/2020/07/herman-cain-hydroxychloroquine/ 
(viewed 
August 9, 2020). 
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from COVID-19 and quoted his brother Judge Peter Vallone as saying that “big 
money does not want this drug to be used. Always follow the money,” while he 
linked to a study by New York University demonstrating the efficacy of HCQ to 
treat COVID-19.8,9 
In the district court proceeding, Respondents raised issues of standing and 
reviewability, but both are easily resolved in favor of AAPS as it argued below.  
AAPS has standing in its own right because FDA’s actions impair AAPS’s own 
First Amendment activity (Doc. 13, at 11-12), and FDA’s actions irrationally 
impede the ability of AAPS’s member physicians to practice their profession (id. at 
12-21).  As to reviewability, FDA’s rescission of its EUA included further 
arbitrary action, and thus is reviewable (id. at 21-22). 
Timely consideration and resolution of AAPS’s motion for a preliminary 
injunction is essential to stem the ongoing irreparable harm from Respondents’ 
arbitrary actions, false disparagement, and hoarding of HCQ in the Strategic 
National Stockpile, where it deteriorates rather than being used as intended. 
 
8 https://nypost.com/2020/08/08/nyc-councilman-credits-hydroxychloroquine-for-
covid-19-
recovery/?utm_source=email_sitebuttons&utm_medium=site%20buttons&utm_ca
mpaign=site%20buttons (viewed August 9, 2020). 
9 
https://www.ny1.com/nyc/all-boroughs/news/2020/05/12/nyu-study-looks-at-
hydroxychloroquine-zinc-azithromycin-combo-on-decreasing-covid-19-deaths 
(viewed 
August 9, 2020). 
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CONCLUSION 
 
AAPS respectfully requests that this Court order the district court to 
promptly rule on the pending motion for a preliminary injunction, and that this 
Court enjoin Respondents from taking any action in the meantime contrary to the 
relief sought in the pending motion.  
 
Dated:  August 10, 2020  
Respectfully submitted, 
 
 
 
 
 
/s/ Andrew L. Schlafly 
  
 
 
 
 
 
Andrew L. Schlafly  
 
 
 
 
 
General Counsel 
 
 
 
 
 
Association of American Physicians & Surgeons 
 
 
 
 
 
939 Old Chester Road 
 
 
 
 
 
Far Hills, New Jersey 07931 
 
 
 
 
 
Tel: 908-719-8608 
 
 
 
 
 
Fax: 908-934-9207 
 
 
 
 
 
Email: aschlafly@aol.com  
 
 
 
 
 
 
Attorney for Petitioner Association of American 
 
Physicians & Surgeons  
 
 
CERTIFICATE OF SERVICE 
 
I hereby certify that on August 10, 2020, I electronically filed the foregoing 
with the Clerk of the Court for the United States District Court for the Western 
District of Michigan by using the CM/ECF system, thereby providing service on 
all parties and providing notice to the court itself.  I certify that all participants in 
the case are registered CM/ECF users. 
 
s/ Andrew L. Schlafly 
 
Attorney for Petitioner 
 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 20 filed 08/10/20   PageID.812   Page 11 of 11

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