Motion For Evidentiary Hearing - ECF 50
Motion For Evidentiary Hearing - ECF 50
Motion For Evidentiary Hearing - ECF 50
COVID-19 vaccines and which Defendants contend moots certain Plaintiff claims;
and (2) whether the Coast Guard has employed “digital tools,” including the
Template Generator, see Ex. 1 (ECF 44-1), and a Denial Letter Template, see Ex. 2
vaccine mandate (“DoD Mandate”) through the present day, the DoD has
1
Case 3:22-cv-00265 Document 50 Filed on 11/07/22 in TXSD Page 2 of 23
Centers for Disease Control and Prevention (“CDC”), and the Food and Drug
Administration (“FDA”) confirm that over 49,000 of the 50,000 (or roughly 98%)
of the DoD’s inventory of FDA-licensed vaccines that they seek to mandate (and
the purportedly renders Plaintiffs’ claims moot) are in fact unlicensed and
misbranded EUA vaccines, most of which expired no later than November 1, 2022.
In a related proceeding in the Northern District of Florida, the DoD filed the
declaration of Air Force Colonel Tanya Rans, which includes a spreadsheet listing
18, 2022. See Ex. 3, originally filed in Coker v. Austin, No. 3:21-cv-1211-AW-HTC
(N.D. Fla. Oct. 18, 2022), ECF 124-1, Rans Decl. & Ex. A. This official DoD record
and sworn testimony confirms Plaintiffs’ allegation that the DoD and Coast Guard
are mandating the unlicensed and untested “bivalent” vaccines that were granted
EUA on August 31, 2022, without any human testing whatsoever – see ECF 25, PL
Reply Br., at 9-10 – notwithstanding Defendants denials. See, e.g., ECF 47, DF Sur-
vaccines from lots GH9667, GH9702, and GJ6665 (collectively, the “G Lots”) that
COMIRNATY” shots. See Ex. 3, Rans Decl., ¶ 4 & Ex. A. This is an admission that
numerous federal and state laws. It also demonstrates that Plaintiffs’ claims are
not moot because: (1) it represents yet another repetition of Defendants’ previous
2
Case 3:22-cv-00265 Document 50 Filed on 11/07/22 in TXSD Page 3 of 23
Defendants against Plaintiffs because, even if they were to receive a primary series
the “FW Lots”). 2 Each of these lots were manufactured at the Pharmacia & Upjohn
licensed manufacturing facility when these lots were manufactured, released into
interstate commerce, or received by the DoD and Coast Guard. Accordingly, none
of the shots from these lots is FDA-licensed and cannot be labeled as FDA-licensed
Comirnaty. See infra Section III.A. In addition, each of the shots from these lots
1The previous violations of the prohibition on mandating EUA products are set
forth in: (1) the September 13, 2021 Interchangeability Directive for Pfizer EUA
and licensed products, see ECF 1-7; (2) the May 3, 2021 Interchangeability
Directive for Moderna EUA and licensed products, see ECF 1-8; and (3)
Defendants’ previous offer of FW Lots of “Comirnaty-labeled” products that are
unlicensed EUA products. See generally ECF 25, PL Reply Br., at 7-10 & infra
Section IV.
2 The list also includes 60 doses from Lot 4302MF023 (which is Novavax, rather
than Pfizer, and subject to an EUA) and 11,298 “Comirnaty-labeled” doses from an
unidentified “(blank)” lot that “refers to sites that have not updated the logistics
system with the associated lot number.” Ex. 3, Rans Decl., Ex. A. The unidentified
doses should be presumed to be EUA bivalents lot because these lots were the most
recently manufactured (July 2022) and acquired (August or September 2022),
while the DoD has been in possession of the FW Lots for over four months starting
in June 2022.
3
Case 3:22-cv-00265 Document 50 Filed on 11/07/22 in TXSD Page 4 of 23
expired no later than October 31, 2022, and many expired well before that in
August or September 2022. See infra III.D. The unlicensed and/or expired FW and
G Lots account for over 49,000 of the just over 50,000 purportedly licensed
The final section of this motion will address the Coast Guard’s “Digital
Tools” (i.e., the RAAG and Denial Letter Template) to categorically deny all RARs,
The federal Food, Drug, and Cosmetic Act (“FDCA”) proceeds from a
proves that the product can meet the statute’s extensive requirements. See 21 U.S.C.
§355(a) (“No person shall introduce or deliver for introduction into interstate
subsection (b) or (j) is effective with respect to such drug.”)(emphasis added). The
entire reason for a new drug application – and the burden on the applicant – is to
prove by “adequate and well-controlled studies,” see 21 C.F.R. §314.126, that the
drug is “safe” for mass distribution and “effective” for the purposes it claims. See
4
Case 3:22-cv-00265 Document 50 Filed on 11/07/22 in TXSD Page 5 of 23
– full reports of investigations which have been made to show whether such drug
Biologics are regulated and held to analogous, but higher standards under
the Public Health Service Act (“PHSA”). 42 U.S.C. § 262. This is due in large part
to the chemical differences between drugs and biologics: drugs are, generally
speaking, stable chemical formulations, while biologics are not. Drugs are
produced in a form (pill, capsule, or liquid) with relatively long shelf-lives and
have been isolated and then attenuated in some fashion. They (typically) have very
commercial grade freezers, because they break down at normal room temperatures.
Notwithstanding that the current mRNA products at issue in this case contain no
Covid-19 virus at all, the shots have similar challenges to traditional vaccines with
biologics manufacturer demonstrate that the biologic: (1) is “safe, pure, and potent”
3See, e.g., Uddin MN, Roni MA. “Challenges of Storage and Stability of mRNA-
Based COVID-19 Vaccines.” Vaccines (Basel). 2021 Sep 17; 9(9):1033. PMCID:
PMC8473088. (“…instability and ultracold storage requirement of mRNA vaccines
remain major limitations. The stability of this emerging and fast-growing vaccine
platform is poorly understood, and it likely depends on multiple factors, such as
excipients, pH, and temperature.”).
5
Case 3:22-cv-00265 Document 50 Filed on 11/07/22 in TXSD Page 6 of 23
(the equivalent of a drug’s requirement to be “safe and effective”); and (2) that “the
meets standards designed to assure that the biological product continues to be safe
The PHSA includes detailed requirements regarding the labeling for biologics.
health and safety of individuals being injected with these substances. The
conventions for biologics after the passage of the 2009 Biologic Price
6
Case 3:22-cv-00265 Document 50 Filed on 11/07/22 in TXSD Page 7 of 23
To help ensure patient safety and allow the Agency and the
manufacturer to swiftly identify and address a problem, FDA
aims to track adverse events to a specific manufacturer (and as
appropriate, to a lot or manufacturing site for a particular
biological product) and allow surveillance systems to detect
safety signals throughout the life cycle of a product. Identifying
a biological product’s manufacturer can help target remedial
action (including recall) to avoid implicating a broader set of
products for which no such problem exists. 4
Mislabeling is a crime under both the FDCA and the PHSA. “A drug or device
PHSA states that “No person shall falsely label or mark any package or container
of any biological product or alter any label or mark on the package or container of
(penalties for violations are listed under subsection (f), including a fine not
§331(a)-(c). District courts are specifically given the authority to enjoin violations
7
Case 3:22-cv-00265 Document 50 Filed on 11/07/22 in TXSD Page 8 of 23
The code of federal regulations supplements the statutes with the FDA’s
§ 201.1 - 201.328 (for drugs), and 21 C.F.R. §610.60 - 610.68 (for biologics).
Package labeling requirements are not optional, nor are they discretionary. “The
following items shall appear on the label affixed to each container…” 21 C.F.R.
§610.60(a)(emphasis added). In the event that a product’s container does not have
sufficient space to include all of the required label items, then the biologic
information. Id.
The FDA – as the agency charged with overseeing these requirements – has a
number of mechanisms in place to help ensure that both the biologics themselves
and the facilities where they are “manufactured, processed, packed, or held” can
account for a biologic’s care and handling from its initial manufacture, packing,
shipping, storage, delivery, holding, and ultimately injection into its intended human
recipients. Defendant FDA’s need (and statutory duty) to track biologics relies upon
vaccines, Ex. 3, Rans Decl., ¶ 4, that are identified as “PFIZER GREY CAP
COMIRNATY.” Id., Ex. A. This list includes the FW Lots, as well as vaccines from
8
Case 3:22-cv-00265 Document 50 Filed on 11/07/22 in TXSD Page 9 of 23
On October 20, 2022, Air Force Master Sergeant Nickolas Kupper accessed
the Centers for Disease Control and Prevention’s (“CDC”) vaccine lot number
database to identify the National Drug Code (“NDC”) for the G Lots. The NDC for
each of the three G Lots is 59267-0304. See Ex. 4, Kupper Decl., ¶ 4 & Kupper Ex.
A (query results from CDC database). According to the CDC NDC website, NDC
59627-0304 is the NDC assigned to the EUA Pfizer bivalent COVID-19 vaccine, 5
rather than 0069-2025, which is the NDC for Pfizer Grey Cap Comirnaty. See infra
Section III.A.
This demonstrates that Defendants seek to mandate EUA products that are
The PHSA prohibits unlicensed products from being labeled using the proprietary
an unlicensed product as a licensed product violates not only the PHSA and FDA
regulations, see supra Section I.B, but also numerous federal and state laws
9
Case 3:22-cv-00265 Document 50 Filed on 11/07/22 in TXSD Page 10 of 23
admission of knowing illegal conduct by all Defendants that also implicates the
manufacturers.
2022 (FW1330 and FW1331 expiring September 30, 2022) or February 2022
(FW1333 expiring October 31, 2022). See Ex. 5, FW1330 Lot Release Letter, at 1;
Ex. 6, FW1331 Lot Release Letter, at 1 (same as ECF 37-1, Burk Decl., Ex. 1); Ex. 7,
FW 1333 Lot Release Letter, at 1. As explained below, official FDA and CDC records
confirm that the Kalamazoo Facility was not an FDA-approved on any of the
6 Moreover, each of these lot release letters includes the Submission Tracking
Number (“STN”) 125742/36 associated with the December 16, 2021 Supplemental
Approval (“December 16 Letter”), see Ex. 8, December 16 Letter, at 1, of the Puurs,
Belgium facility as the sole manufacturer of the at that time new Tris/Sucrose
formulation, rather than the STN 12574/44 associated with the non-public
January 14, 2022 letter (“January 14 Letter”) submitted by Defendants. See ECF
37-2, Burk Decl., Ex. 1. The January 14 Letter purported to approve the Kalamazoo
Facility, and thus any lots manufactured there would have been associated with the
January 14 Letter STN (12574/44), rather than the December 16 Letter, which was
assigned STN (12574/36). See Ex. 8, December 16 Letter, at 1. The December 16
Letter could not have authorized manufacture at the Kalamazoo Facility.
10
Case 3:22-cv-00265 Document 50 Filed on 11/07/22 in TXSD Page 11 of 23
on August 23, 2021, license No. 2229, with the licensed, proprietary name
“Comirnaty.” See ECF 1-15, August 23, 2021 Comirnaty Purple Cap Approval Letter,
Belgium and at the Kalamazoo Facility, id., as set forth in the Pfizer Comirnaty
Purple Cap package insert (Ex. 9), a screenshot of which is reproduced below. 7
On December 16, 2021, the FDA granted approval for a BLA Supplement for
Ex. 8, December 16 Letter, at 1. The December 24, 2021 package insert for the
Comirnaty Tris/Sucrose “Grey Cap” vial reflects only one facility approved to
conduct all four functions, analysis, manufacture, pack, and label: Pfizer
7The NDC label identifier for the original Purple Cap COMIRNATY is 0069-1000.
See Ex. 10, August 23, 2021 Comirnaty Purple Cap Package Insert at 14-15. Purple
Cap Comirnaty was never produced or marketed in the United States because the
marketing start and end date were both August 23, 2021. See id. at 20.
11
Case 3:22-cv-00265 Document 50 Filed on 11/07/22 in TXSD Page 12 of 23
Manufacturing Belgium NV (i.e., Puurs, Belgium). See Ex. 10, Dec. 22, 2021
Comirnaty Tris/Sucrose Package Insert, at 18. The package insert has a marketing
start date of December 22, 2021, with NDC label identifier of 0069-2025 (Grey Cap,
updated package insert that the FDA approved on May 19, 2022 (the day before it
became orderable by the DoD), and with a May 18, 2022 marketing start date and
no marketing end date. See Ex. 11, May 19, 2022 Comirnaty Tris/Sucrose Package
Insert, at 32. Once again, only the Pfizer site in Puurs, Belgium is listed as the only
location where analysis, manufacture, pack and labeling may be performed. See id.
at 32-33. Neither the Kalamazoo Facility, nor any other U.S. location is listed in
the package insert. Accordingly, the Kalamazoo Facility was not an FDA-approved
manufacturing location when it was released into interstate commerce by the Lot
12
Case 3:22-cv-00265 Document 50 Filed on 11/07/22 in TXSD Page 13 of 23
Even assuming arguendo that the manufacturing site information was not
required, the previous, archived package inserts submitted by Plaintiffs listed the
approved manufacturers, a list that did not include the Kalamazoo Facility. See Ex.
10, Dec. 22, 2021 Comirnaty Tris/Sucrose Package Insert at 19; Ex. 11, May 19,
version of the package insert for the bivalent lots also lists the approved
manufacturers, a list that now includes the Kalamazoo Facility and the Hospira
facility in McPherson, Kansas. See Ex. 12, Pfizer Bivalent COVID-19 Vaccine
Letter, at 1; Ex. 13, July 8, 2022 2021 Supplemental Approval Letter (“July 8
Letter”), at 1; Ex. 14, August 25, 2022 Supplemental Approval Letter (“August 25
not used and thus does not approve the manufacture of COMIRNATY at the
Kalamazoo Facility. The letter uses only the generic name “Covid-19 vaccine
draft labels and package inserts that reflect the new approved locations,
formulation and/or indications. See Ex. 8, December 16 Letter, at 1-2; Ex. 13, July
13
Case 3:22-cv-00265 Document 50 Filed on 11/07/22 in TXSD Page 14 of 23
8 Letter, at 1-2; Ex. 14, August 25 Letter, at 1-2. This is because a manufacturer
must file a supplemental BLA, and receive prior FDA approval, before the
indication). See 21 C.F.R. § 601.12(b)(1) (“a supplement shall be submitted for any
manufacturer must submit proposed changes to the label and package insert to
reflect the changes for which approval is sought in the supplemental BLA. See 21
location on the label and package insert, as required by FDA regulations. This
should render the January 14 Letter invalid on its face, as there is no indication
that the FDA did (or legally could) waive the mandatory labeling requirements in
Third, the vials themselves do not list Pharmacia & Upjohn or the Kalamazoo
GmbH & Pfizer Inc.” See ECF 25-2, Aug. 18, 2022 Letter from Sen. Ron Johnson
to CDC, DoD and FDA, at 1 (vial from Lot FW1331 with “9/2022” expiration date).
Fourth, the STN for the three FW Lot Release Letters, see Exs. 5-7, matches
that for the December 16 Letter (STN BL 125742/36), see Ex. 8, rather than for the
January 14 Letter (STN BL 125742/44). See ECF 37-2, Burk Decl., Ex. 1.
14
Case 3:22-cv-00265 Document 50 Filed on 11/07/22 in TXSD Page 15 of 23
The product labels and the Lot Release Letters both state that the expiration
date for Lots FW1330 and FW1331 is September 30, 2022, see Ex. 5-6, and the
expiration date for Lot FW 1333 is October 31, 2022. See Ex. 7. Further, the
currently effective and all previous, archived versions of the Pfizer Comirnaty Grey
vaccine should not be used after the expiration date printed on the vial
and cartons.” 8
In the Coker v. Austin proceeding, Defendants also submit an April 14, 2022
FDA letter that purports to “extend[] the expiration period … from 9 months to 12
months.” See Ex. 15, Coker v. Austin, No. 3:21-cv-1211-AW-HTC (N.D. Fla. Oct. 18,
2022), ECF 124-2, Burk Decl., Ex. 1. Defendants do not, however, cite any authority
that would permit the FDA to waive or override a labeling requirement mandated
by statute and FDA regulations, or the actual expiration date stated in the product
At most, the April 14 Letter would have permitted Pfizer to modify the
expiration date printed on the product labeling, which was not done. 9 Pfizer could
have revised the package insert to state that the expiration should be extended in
accordance with the April 14 Letter, but it did not do so, and all versions of the
FDA-approved package inserts (whether before or after April 14, 2022) contain the
same directive not to use the product after the expiration date stated on the label.
Moreover, the PHSA and FDA labeling regulations all refer to the requirements
and do not refer to the FDA’s approval letter. These package inserts, approved by
the FDA after the issuance of the April 14 Letter, must trump the previous April 14
Letter, both as a matter of law and the practical reality that patients, doctors and
pharmacists must rely on what is actually stated on the packaging. Accordingly, all
doses from Lot FW1330 and FW1331 expired as of September 30, 2022, and all
doses from Lot FW1333 will expire at the latest on October 31, 2022 (i.e., six days
stated on the label, once the vials are taken out of deep freeze they may be
18, 2022. The FDA’s FW1333 Lot Release Letter, issued several days later on April
19, 2022, states that the expiration date is “October 31, 2022.” Ex. 7, FW 1333 Lot
Release Letter, at 1.
10Even assuming arguendo that the April 14 Letter could override FDA regulations
and the FDA-approved labeling, Defendants have provided no evidence
whatsoever that any of the doses in the FW Lots met the requirement for expiration
date extension, namely, that these vials were continuously stored “between -90 ⁰C
and -60 ⁰C.” ECF 124-1, April 14 Letter, at 1.
16
Case 3:22-cv-00265 Document 50 Filed on 11/07/22 in TXSD Page 17 of 23
expiry date.” Ex. 11, May 19, 2022 Comirnaty Tris/Sucrose Package Insert, at 25-
⁰C to 8 ⁰C must “be stored at 2 ⁰C to 8 ⁰C” and “they should not be refrozen.” Id.
These FDA requirements are reflected in DoD and Armed Services transportation
and storage procedures, which stipulate that Pfizer Gray Cap Comirnaty must be
“ship[ped] refrigerated” at “2C to 8C with a 10 week shelf life.” Ex. 4, Kupper Decl.,
Defendants’ filings indicate that they received the FW Lots in early June
2022. These lots were then redistributed from Ft. Detrick to military facilities at
refrigerated temperatures rather than deep freeze, which triggered the 10-week
expiration period that ended in August 2022. See Ex. 4, Kupper Decl., ¶ 10.
Joshua Hoppe. CAPT Hoppe is stationed in Yuma, Arizona, which according to the
Rans Declaration had doses of Pfizer Grey Cap Comirnaty from Lot FW1333 as of
October 18, 2022. See Ex. 3, Rans Decl., Ex. A. On October 19 and 21, 2022, the
Yuma Clinic informed CAPT Hoppe that the Yuma Clinic no longer had any
Comirnaty-labeled vaccines because all of the doses they had expired August 26,
2022 (i.e., due to the 10-week refrigeration expiration period). See Ex. 16, Hoppe
Decl., ¶¶ 4-5.
The CDC maintains a listing of “all lots for COVID-19 vaccines made
17
Case 3:22-cv-00265 Document 50 Filed on 11/07/22 in TXSD Page 18 of 23
available under Emergency Use Authorization (EUA) for distribution in the United
EUA products until as recently as October 18, 2022. This is confirmed by the
August 4, 2022 Declaration of Army Lieutenant Mark Bashaw, which was included
September 6, 2022 Reply Brief. See ECF 27-1, Coppin Decl., at 26 (Bashaw Decl.,
Plaintiffs’ statutory claims are not moot because Defendants’ violations are
“capable of repetition, yet evading review” and “there [is] a reasonable expectation
that [Plaintiffs will] be subjected to the same action again.” Fla. Bd. of Bus. Regul.
v. N.L.R.B., 605 F.2d 916, 920 (5th Cir. 1979) (citation and quotation marks
least September 14, 2021, see ECF 1-7, Pfizer Interchangeability Directive, through
the present, as confirmed by the fact that they are mandating unlicensed,
deployment for several months. Plaintiffs provide the sworn declaration U.S.
Marine Corps Senior Chief Petty Officer (“SCPO”) Dixon Brown, who serves as a
Senior Enlisted Medical Advisor responsible for EUA and informed consent
18
Case 3:22-cv-00265 Document 50 Filed on 11/07/22 in TXSD Page 19 of 23
confirms that the U.S. Marine Corps requires EUA boosters for new accessions and
for deployments. 11
to this same statutory violation again because, even if each Plaintiff were to become
The Coast Guard has employed “Digital Tools,” including the RAAG and
Denial Letter Template, to categorically deny all Coast Guard members’ RARs,
including those of several Plaintiffs and Intervenor Plaintiffs. This can be easily
the denial letters of Plaintiffs. Plaintiffs provide the sworn declaration and
showing how the Denial Letter Template was (incorrectly) used for his denial
11See Ex. 18, SCPO Brown Decl., ¶¶ 14-15 & SCPO Brown Ex. 4. Due to the credible
threat of retaliation, Plaintiffs intend to submit, under seal, additional declarations
and testimony from other fully vaccinated service members throughout the Armed
Services who have been required to take EUA boosters.
19
Case 3:22-cv-00265 Document 50 Filed on 11/07/22 in TXSD Page 20 of 23
USCG denied all, or nearly all, RARs and dismissed appeals “en masse with the
determinations were taking place.” ECF 43-1, at 2. The use of these tools to
implement the Categorical RAR Ban is fully consistent with the sworn testimony
who is assigned to the Coast Guard, describing the directives from Coast Guard
leadership that RARs would not be granted and that, even if an RAR was granted,
It is also consistent with the findings of the DoD’s Office of the Inspector
General’s (“IG”) June 2, 2022 Report to Secretary Austin (“DoD IG Report”). See
Ex. 19. There, the DoD IG made DoD-wide preliminary findings that the RAR
and the DoD and Military Services policies,” Ex. 19, DoD IG Report at 1, i.e., RFRA,
This is also consistent with the findings of several courts that Secretary
Austin and the DoD have implemented a DoD-wide Categorical RAR Ban. The
Department of the Navy, of which the Coast Guard is a part, also employed similar
12See, e.g., ECF 25-9, Brown Supp. Decl., ¶ 7 (September 20, 2021 email informed
service members that “even if a religious accommodation or medical exemption
were approved the member was likely to still be administratively separated.”); ECF
1-2, Wilder Decl., ¶ 7 (commander informed Plaintiff Wilder that members would
not “be allowed to continue to serve if exempted. …. either way if they don’t get the
vaccine, [you] will be discharged.”).
20
Case 3:22-cv-00265 Document 50 Filed on 11/07/22 in TXSD Page 21 of 23
“digital tools” to implement the Navy’s Categorical RAR Ban and to automatically
generate denial letters. See ECF 60-9, Navy Whistleblower Testimony; Navy
SEALs 1-26 v. Austin, 2022 WL 34443, at *6 (N.D. Tex. Jan. 3, 2022) (granting PI
Coast Guard has unlawfully used “Digital Tools” to categorically deny Coast Guard
members’ RARs and therefore their religious liberties, including those of Plaintiffs
and Intervenor Plaintiffs. This Court should permit Plaintiffs to seek discovery of
relevant documents that would bear these issues and to depose Defendants’
officials who have generated these records or who can testify on behalf of the
VII. CONCLUSION
or find based on the record before it that Plaintiffs’ statutory claims are not moot;
that the G Lots are misbranded, unlicensed EUA lots; that all FW Lots expire no
later than November 1, 2022; and that the Coast Guard’s “Digital Tool” and RAAG
have been used to categorically deny Coast Guard members RARs, without any
Members’ rights under RFRA, the First Amendment Free Exercise Clause, and the
22
Case 3:22-cv-00265 Document 50 Filed on 11/07/22 in TXSD Page 23 of 23
CERTIFICATE OF SERVICE
This is to certify that on this 7th day of November, 2022, the foregoing
Respectfully Submitted,
CERTIFICATE OF CONFERENCE
23