Complaint (2022-03-02)
- Date
- 2022-03-02
Summary
Defendants' Response to Plaintiffs' Supplement, filed March 2, 2022 as Document 48 in America's Frontline Doctors, et al. v. United States of America, et al., Civil Action No. 2:21-cv-00702-CLM, in the U.S. District Court for the Northern District of Alabama. The response argues that the Excel file plaintiffs submitted is irrelevant to the case and that the Department of Defense has explained its data as the product of a glitch in the Defense Medical Epidemiology Database. It argues the supplement does not address any named plaintiff or any of the six counts in the Amended Complaint and cannot overcome the pending motion to dismiss or support a preliminary injunction. The defendants ask the Court to dismiss the Amended Complaint and deny the preliminary injunction motion. The filing is signed by Trial Attorney Isaac C. Belfer of the U.S. Department of Justice.
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Case 2:21-cv-00702-CLM Document 48 Filed 03/02/22 Page 1 of 8 FILED
2022 Mar-02 PM 02:31
U.S. DISTRICT COURT
N.D. OF ALABAMA
IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ALABAMA
SOUTHERN DIVISION
AMERICA’S FRONTLINE
DOCTORS, et al.,
Plaintiffs,
CIVIL ACTION NO.
v. 2:21-CV-702-CLM
OPPOSED
UNITED STATES OF AMERICA, et
al.,
Defendants.
DEFENDANTS’ RESPONSE TO PLAINTIFFS’ SUPPLEMENT
The Court authorized Plaintiffs to submit a supplement, “the purpose of which
is to explain the relevance and significance of the Excel file” they provided to the
Court. ECF No. 46. Although Plaintiffs acknowledge their responsibility to establish
“the relevance of the Excel file,” ECF No. 47, at 1, they do not do so. Indeed, the
Excel file is irrelevant to this case. What’s more, the data it contains is incorrect. The
Court should disregard Plaintiffs’ supplement and dismiss this case.
According to Plaintiffs, the Excel file shows that “prior to the commencement
of vaccination within the [Department of Defense (“DOD”)] with the mRNA
COVID-19 vaccines, the incidence of certain diseases and medical conditions
among DOD personnel was predictable and constant at a certain level over a number
of years from 2016 to 2020.” ECF No. 47, ¶ 6. But Plaintiffs assert that “after the
commencement of vaccination within the DOD with the mRNA COVID-19 vaccines
Case 2:21-cv-00702-CLM Document 48 Filed 03/02/22 Page 2 of 8
in 2021, the incidence of these diseases and medical conditions among DOD
personnel spiked dramatically.” Id.
As Plaintiffs concede, DOD has already explained that the data in the Excel
file is incorrect and is the product of a “glitch” in the Defense Medical Epidemiology
Database (“DMED”) that “resulted in artificially low incidence numbers in the years
2016–2020.” ECF No. 47, ¶ 8.1 Plaintiffs reject this explanation, however, and
instead accuse the government of “alter[ing]” the data in DMED “to distort and hide
the true extent of the harm caused to the US Armed Forces by the mRNA vaccines.”
ECF No. 47, Ex. C. Plaintiffs’ unsupported speculation should not be countenanced
by the Court.
More fundamentally, Plaintiffs’ supplement is improper because Plaintiffs
failed to heed the Court’s direction to explain the Excel file’s “relevance and
significance” to this case. ECF No. 46. Plaintiffs’ supplement does not reference any
of the eight named Plaintiffs, nor does it cite any of the six counts in the Amended
Complaint (ECF No. 32-1) or explain how the Excel file is relevant to them. The
Amended Complaint, moreover, does not mention DMED, does not name as parties
any members of the military, and does not assert any claims against the military.
Plaintiffs’ supplement is entirely untethered to the Amended Complaint.
The supplement also makes no attempt to show the Excel file’s “relevance
and significance” (ECF No. 46) to Plaintiffs’ pending preliminary injunction motion
1
See Reuters, Fact Check-DoD says data error caused spike in numbers of medical diagnoses in
their medical database for 2021, https://www.reuters.com/article/factcheck-militarydatabase-
error/fact-check-dod-says-data-error-caused-spike-in-numbers-of-medical-diagnoses-in-their-
medical-database-for-2021-idUSL1N2UY1S2 (Feb. 23, 2022).
2
Case 2:21-cv-00702-CLM Document 48 Filed 03/02/22 Page 3 of 8
or Defendants’ pending motion to dismiss. Nor could Plaintiffs have met that burden
had they tried. The supplement cannot overcome Defendants’ arguments that the
Court lacks subject matter jurisdiction because (1) no plaintiff possesses standing or
ripe claims; (2) the challenged actions taken under 21 U.S.C. § 360bbb-3 are not
reviewable under the Administrative Procedure Act (“APA”); (3) no jurisdiction
exists under the mandamus statute or the Declaratory Judgment Act; and (4) the Civil
Service Reform Act precludes jurisdiction over any challenge by Plaintiffs Nelson
and Leahy to potential adverse employment action reviewable under that statute.
The supplement also cannot rebut Defendants’ arguments that the Amended
Complaint fails to state a plausible claim for relief because (1) Counts I, III, and IV
do not purport to challenge the Emergency Declaration and Emergency Use
Authorizations in light of Defendants’ contemporaneous explanations and the
existing administrative record, as required for an APA claim; (2) Executive Orders
14042 and 14043 (collectively, the “Executive Orders”) are not reviewable under
the APA because the President is not an “agency”; (3) the Executive Orders do not
deprive Plaintiffs of substantive due process; and (4) the Executive Orders are within
the President’s statutory authority. Moreover, the new allegations in Plaintiffs’
supplement could not defeat Defendants’ motion to dismiss because they are outside
“the four corners of the [amended] complaint.” St. George v. Pinellas Cty., 285 F.3d
1334, 1337 (11th Cir. 2002). And although “[a]ll counts in the amended complaint
are predicated on” the APA, ECF No. 37, at 41, Plaintiffs’ supplement cannot
support an APA claim because it presents new evidence that is outside “the existing
administrative record,” Dep’t of Com. v. New York, 139 S. Ct. 2551, 2573 (2019),
3
Case 2:21-cv-00702-CLM Document 48 Filed 03/02/22 Page 4 of 8
and it does not claim that its allegations were ever presented to Defendants, Mahon
v. U.S. Dep’t of Agric., 485 F.3d 1247, 1254–55 (11th Cir. 2007); see 21 C.F.R.
§§ 10.25, 10.30, 10.45.
Finally, Plaintiffs’ supplement cannot support their preliminary injunction
motion. It cannot show a likelihood of success on the merits because it cannot
overcome Defendants’ showing that the Amended Complaint should be dismissed
for lack of subject matter jurisdiction and failure to state a claim. See Klay v. United
Healthgroup, Inc., 376 F.3d 1092, 1097–98 (11th Cir. 2004) (“For a traditional
injunction to be even theoretically available, a plaintiff must be able to articulate a
basis for relief that would withstand scrutiny under Fed. R. Civ. P. 12(b)(6).”).
Moreover, the supplement cannot support preliminary relief because it addresses “a
matter lying wholly outside the issues in the suit.” Kaimowitz v. Orlando, 122 F.3d
41, 43 (11th Cir. 1997), opinion amended on reh’g, 131 F.3d 950 (11th Cir. 1997).
Silent about any named Plaintiff, the supplement also cannot show that any
Plaintiff would suffer irreparable harm “before [this] case can be resolved on its
merits.” Wreal, LLC v. Amazon.com, Inc., 840 F.3d 1244, 1248 (11th Cir. 2016). As
Defendants explained in their reply brief, there is no imminent risk that the Executive
Orders will force Plaintiffs Makowski, Nelson, and Leahy to receive any COVID-
19 vaccine, let alone one authorized under an Emergency Use Authorization.
Makowski’s medical accommodation request was granted; Nelson’s and Leahy’s
religious accommodation requests remain pending; and Nelson’s and Leahy’s
employer has paused the processing of their religious accommodation requests in
compliance with the nationwide preliminary injunction enjoining enforcement of
4
Case 2:21-cv-00702-CLM Document 48 Filed 03/02/22 Page 5 of 8
Executive Order 14043 issued in Feds for Med. Freedom v. Biden, No. 3:21-CV-
356, 2022 WL 188329, at *7–8 (S.D. Tex. Jan. 21, 2022), appeal filed, No. 22-40043
(5th Cir. Jan. 26, 2022).2 ECF No. 44, at 7–8 & n.5.
Instead of attempting to show a connection to this case, Plaintiffs’ supplement
focuses on wholly unrelated conduct: the Department of Defense’s maintenance of
DMED. Federal courts, however, “do not possess a roving commission,” and they
do not “exercise general legal oversight of the Legislative and Executive Branches.”
TransUnion LLC v. Ramirez, 141 S. Ct. 2190, 2203 (2021). Plaintiffs’ counsel may
not use this lawsuit to pursue matters unrelated to the claims at issue in this case.
In sum, the Court should disregard Plaintiffs’ supplement because Plaintiffs
have failed to show that it has any “relevance [or] significance” to this case. ECF
No. 46. For the reasons stated in Defendants’ briefs, see ECF Nos. 42, 44, the Court
should dismiss Plaintiffs’ Amended Complaint pursuant to Federal Rule of Civil
Procedure 12(b)(1) and (b)(6) and deny Plaintiffs’ motion for a preliminary
injunction.
Dated: March 2, 2022 Respectfully submitted,
OF COUNSEL: BRIAN M. BOYNTON
Principal Deputy Assistant Attorney
DANIEL BARRY General
Acting General Counsel
2
In addition, the Southern District of Georgia has issued a nationwide preliminary injunction
enjoining enforcement of Executive Order 14042. Georgia v. Biden, No. 1:21-CV-163, 2021 WL
5779939, at *12 (S.D. Ga. Dec. 7, 2021), appeal filed, No. 21-14269 (11th Cir. Dec. 10, 2021);
see Feds for Med. Freedom, 2022 WL 188329, at *1 (denying motion to preliminarily enjoin
enforcement of Executive Order 14042 because that Executive Order “is already the subject of a
nationwide injunction” that “protects the plaintiffs from imminent harm”).
5
Case 2:21-cv-00702-CLM Document 48 Filed 03/02/22 Page 6 of 8
U.S. Department of Health and Human ARUN G. RAO
Services Deputy Assistant Attorney General
WENDY VICENTE GUSTAV W. EYLER
Acting Deputy Chief Counsel, Director
Litigation
HILARY K. PERKINS
JAMES ALLRED Assistant Director
Associate Chief Counsel
Office of the Chief Counsel /s/_ Isaac C. Belfer _____
U.S. Food and Drug Administration ISAAC C. BELFER
10903 New Hampshire Avenue Trial Attorney
White Oak 31, Rm 4564 JAMES W. HARLOW
Silver Spring, MD 20993-0002 Senior Trial Attorney
Consumer Protection Branch
Civil Division
U.S. Department of Justice
P.O. Box 386
Washington, DC 20044-0386
Tel: (202) 305-7134 (Belfer)
Tel: (202) 514-6786 (Harlow)
Fax: (202) 514-8742
Email: Isaac.C.Belfer@usdoj.gov
Email: James.W.Harlow@usdoj.gov
PRIM F. ESCALONA
United States Attorney
DON B. LONG, III
Assistant United States Attorney
United States Attorney’s Office
Northern District of Alabama
1801 Fourth Avenue North
Birmingham, Alabama 35203
Tel: (205) 244-2106
Fax: (204) 244-2171
Email: Don.Long2@usdoj.Gov
Counsel for Defendants the United
States of America; Joseph R. Biden, Jr.,
6
Case 2:21-cv-00702-CLM Document 48 Filed 03/02/22 Page 7 of 8
President of the United States; Xavier
Becerra, Secretary of Health and
Human Services; Dr. Anthony Fauci,
Director of the National Institute of
Allergy and Infectious Diseases; Dr.
Janet Woodcock, Acting Commissioner
of Food and Drugs; the U.S.
Department of Health and Human
Services; the Food and Drug
Administration; the Centers for Disease
Control and Prevention; the National
Institutes of Health; and the National
Institute of Allergy and Infectious
Diseases
7
Case 2:21-cv-00702-CLM Document 48 Filed 03/02/22 Page 8 of 8
CERTIFICATE OF SERVICE
I hereby certify that on March 2, 2022, I electronically filed the foregoing with
the Clerk of the Court using the CM/ECF system, which will send notification of
such filing to counsel of record.
/s/_ Isaac C. Belfer _____
ISAAC C. BELFER
Trial Attorney
8
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