Opposition Brief — CHD v. FDA

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U.S. District Court for the Western District of Texas, Waco Division · No. 6:22-cv-00093-ADA-DTG · Doc. 19 · 2022-04-29 · Docket on CourtListener

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Defendants' opposition to plaintiffs' motion to stay, filed April 29, 2022 as Document 19 in Children's Health Defense, et al. v. Food & Drug Administration, et al., Case No. 6:22-cv-00093-ADA-DTG, in the U.S. District Court for the Western District of Texas, Waco Division. It opposes a request to suspend the Food and Drug Administration's emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine for children aged 5 to 11, stated to have become effective October 29, 2021. It argues that 5 U.S.C. § 705 permits postponement rather than suspension of an action already in effect, and that plaintiffs have not established jurisdiction, likelihood of success, irreparable injury, or a public interest favoring relief. The background cites the December 2020 authorization under 21 U.S.C. § 360bbb-3 at 86 Fed. Reg. 5200. The brief runs 15 pages.

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UNITED STATES DISTRICT COURT 
FOR THE WESTERN DISTRICT OF TEXAS 
WACO DIVISION 
 
 
Children’s Health Defense, et al., 
 
 
 
 
 
Plaintiffs, 
 
 
v. 
 
Food & Drug Administration, et al., 
 
 
 
 
 
Defendants. 
 
 
 
 
Case No. 6:22-cv-00093-ADA-DTG 
Defendants’ Opposition to Plaintiffs’ Motion to Stay 
 
 
 
  
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TABLE OF CONTENTS 
INTRODUCTION ............................................................................................................................... 1 
BACKGROUND ................................................................................................................................ 2 
LEGAL STANDARD .......................................................................................................................... 3 
ARGUMENT ..................................................................................................................................... 4 
I. 
5 U.S.C. § 705 does not authorize the relief Plaintiffs seek ........................................ 4 
II. 
Plaintiffs also have not clearly established any factor required for relief ............... 6 
A. 
Plaintiffs are not likely to establish jurisdiction, much less succeed on the 
merits ........................................................................................................................... 7 
B. 
Plaintiffs have not convincingly shown any irreparable injury ......................... 9 
C. 
The public interest does not favor depriving all parents of the choice to 
vaccinate their children against COVID-19 ......................................................... 11 
CONCLUSION ................................................................................................................................ 12 
 
 
 
 
 
 
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INTRODUCTION 
The U.S. Food and Drug Administration’s emergency use authorization for 
administration of the Pfizer-BioNTech COVID-19 vaccine to children aged 5 to 11 (“the 
Pfizer EUA”) became effective on October 29, 2021. Nearly six months later (and three 
months after filing suit), Plaintiffs ask this Court to stay—or more precisely, 
“suspend”—the Pfizer EUA pending judicial review because its mere existence 
supposedly threatens irreparable harm. Plaintiffs’ request is statutorily and factually 
unsustainable. 
Plaintiffs invoke 5 U.S.C. § 705, which only permits courts to “postpone” an agency 
action’s effective date or “to preserve status or rights” pending judicial review. The 
plain meaning of “postpone” does not include suspension of an agency action that has 
been in effect for six months. Also contrary to the statute, Plaintiffs’ requested relief 
would alter, not “preserve,” the status quo. Nor are any rights in need of immediate 
preservation given that Plaintiffs Sacha Dietrich and Deborah Else admittedly exercised 
the option for their children not to receive the Pfizer EUA vaccine. 
Even if Plaintiffs’ requested relief could be authorized by 5 U.S.C. § 705, it is not 
merited under the governing preliminary-injunction factors. As discussed in 
Defendants’ pending motion to dismiss, this case should be dismissed for lack of 
subject-matter jurisdiction and failure to state a claim upon which relief can be granted. 
Far from showing a likelihood of success on the merits and irreparable harm, Plaintiffs’ 
submissions with their stay motion underscore the arguments for dismissal.  
Dietrich and Else find third-party “advertisements” about the Pfizer vaccine “most 
bothersome” and objectionable. Such psychic harm is not cognizable, traceable to FDA, 
or irreparable. Likewise, speculation about hypothetical vaccine mandates or 
discriminatory practices is insufficient to establish injury. And binding precedent 
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precludes Children’s Health Defense (“CHD”) from bootstrapping itself into court via 
the voluntary expense of filing this suit. 
Plaintiffs’ failure to establish likely eventual success or irreparable harm cannot be 
rescued by public interest factors. Quite the contrary is true; the public interest also 
strongly disfavors extraordinary relief here. By seeking suspension of the Pfizer EUA, 
Plaintiffs are attempting to impose their preferred views about the vaccine on all 
American families. But just as Dietrich and Else opted to refuse the vaccine for their 
children, other American parents are able to choose differently as they navigate the 
COVID-19 pandemic. Thus, the public interest also favors denying Plaintiffs’ motion so 
that American parents may continue to make their own decisions about whether to 
vaccinate their children. 
BACKGROUND 
The statutory and factual background of this case is set forth in Defendants’ 
pending motion to dismiss. See Defs.’ Mot., ECF No. 18, at 2–5. Only those details 
relevant to the disposition of this motion are recited here.  
In December 2020, FDA issued an EUA, under 21 U.S.C. § 360bbb-3, for the 
COVID-19 vaccine manufactured by Pfizer-BioNTech. See 86 Fed. Reg. 5200 (Jan. 19, 
2021) (initial Pfizer EUA). On October 29, 2021, FDA expanded the scope of the Pfizer 
EUA to include administration to children aged 5 to 11 years. See Ex. 1, Burk Decl., ECF 
No. 18-2 (“January Letter”), at 7;1 see Compl., ECF No. 1, at ¶ 22. The agency did so only 
after concluding, “based on the totality of the scientific evidence available, that the 
                                                 
1 The operative EUA on the Complaint’s filing date was the January 3, 2022 reissuance. 
Burk Decl., ECF No. 18-1, at ¶¶ 5–6; see Newman-Green, Inc. v. Alfonzo-Larrain, 490 U.S. 
826, 830 (1989) (“[F]ederal jurisdiction ordinarily depends on the facts as they exist 
when the complaint is filed.”). “[J]udicial notice of publicly-available documents . . . 
produced by the FDA, which were matters of public record directly relevant to the issue 
at hand is appropriate.” Yosowitz v. Covidien LP, 182 F. Supp. 3d 683, 688 (S.D. Tex. 2016) 
(quotation omitted); see Burk Decl. ¶ 6. 
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known and potential benefits of Pfizer-BioNTech COVID-19 Vaccine outweigh the 
known and potential risks of the vaccine” for those aged 5 through 11 years. January 
Letter 7; see generally Ex. 5, EUA Mem., ECF No. 1, at 178–225. The Pfizer EUA for this 
population group has remained in effect ever since. See January Letter 11. 
On January 24, 2022, about three months after the Pfizer EUA was extended to 
children aged 5 to 11, Plaintiffs filed this suit under the Administrative Procedure Act 
(“APA”). See generally Compl. Another three months after that, on April 15, 2022, 
Plaintiffs moved under 5 U.S.C. § 705 to “suspend” the Pfizer EUA for 5- to 11-year-olds 
“pending judicial review of Plaintiffs’ complaint.” Stay Mem., ECF No. 14, at 14, 20. 
Defendants have already moved to dismiss the Complaint for lack of subject-matter 
jurisdiction and failure to state a claim. Defendants now oppose Plaintiffs’ stay motion. 
LEGAL STANDARD 
“On such conditions as may be required and to the extent necessary to prevent 
irreparable injury,” 5 U.S.C. § 705 permits a “reviewing court . . . to postpone the 
effective date of an agency action or to preserve status or rights pending conclusion of 
the review proceedings.” In considering a stay request under 5 U.S.C. § 705, the Court 
applies the preliminary-injunction standard. See, e.g., State of Colo. v. U.S. EPA, 989 F.3d 
874, 883 (10th Cir. 2021); Texas v. United States, 95 F. Supp. 3d 965, 973 (N.D. Tex. 2015). 
Plaintiffs “must establish that” (1) they are “likely to succeed on the merits,” (2) they are 
“likely to suffer irreparable harm in the absence of preliminary relief,” (3) “the balance 
of equities tips in [their] favor,” and (4) “an injunction is in the public interest.” Winter 
v. Nat. Res. Def. Council, Inc., 555 U.S. 7, 20 (2008). The third and fourth factors “merge 
when the Government is the opposing party.” Nken v. Holder, 556 U.S. 418, 435 (2009). 
“A preliminary injunction is an extraordinary remedy never awarded as of right.” 
Winter, 555 U.S. at 24. It “should not be granted unless” Plaintiffs, “by a clear showing, 
carr[y] the burden of persuasion,” Mazurek v. Armstrong, 520 U.S. 968, 972 (1997), “on all 
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four requirements,” Big Tyme Invs., LLC v. Edwards, 985 F.3d 456, 464 (5th Cir. 2021).2 
Additionally, “preliminary relief, which goes well beyond simply maintaining the 
status quo pendente lite, is particularly disfavored, and should not be issued unless the 
facts and law clearly favor the moving party.” Martinez v. Mathews, 544 F.2d 1233, 1243 
(5th Cir. 1976). 
ARGUMENT 
I. 5 U.S.C. § 705 does not authorize the relief Plaintiffs seek 
Before analyzing the preliminary-injunction factors, Plaintiffs must make a 
threshold showing that 5 U.S.C. § 705 “authorizes the relief” they seek. Nishihata v. 
Blinken, No. CV 21-2173 (CKK), 2021 WL 4476750, at *5 (D.D.C. Sept. 30, 2021). “[T]he 
remedial powers granted to a reviewing court under this section are in fact extremely 
limited.” Salt Pond Assocs. v. U.S. Army Corps of Eng’rs, 815 F. Supp. 766, 775–76 (D. Del. 
1993). Section 705’s prefatory clause “broadly describes when a court is authorized to act 
under this section (i.e., ‘On such conditions as may be required and to the extent 
necessary to prevent irreparable injury’).” Id. at 776 (quoting 5 U.S.C. § 705) (emphasis 
in original). Then, the main clause “narrowly describes the scope of relief the reviewing 
court is authorized to grant,” which is “limited to (1) a postponement of the agency 
action or (2) a preservation of status or rights of the parties.” Id.; see, e.g., Tok Air Serv., 
LLC v. Haaland, No. 4:21-CV-0012-HRH, 2021 WL 3271342, at *5 (D. Alaska July 30, 
2021). Here, Plaintiffs’ requested relief—that the Court “suspend” a portion of the Pfizer 
EUA that has been effective for nearly six months, Stay Mem. 20—fits neither category. 
First, section 705 authorizes “a reviewing court . . . to postpone the effective date of 
an agency action.” 5 U.S.C. § 705 (emphasis added). “The word ‘postpone’ means ‘to 
                                                 
2 Although Plaintiffs claim “authority is split” about how to apply these factors, Stay 
Mem. 14, the Fifth Circuit has reiterated they “are conjunctive,” Lake Charles Diesel, Inc. 
v. Gen. Motors Corp., 328 F.3d 192, 203 (5th Cir. 2003); see, e.g., Big Tyme, 985 F.3d at 464 
(plaintiff must satisfy “all four requirements”) (quotation omitted). 
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put off to a later time,’ or to ‘defer.’” Ctr. for Biological Diversity v. Regan, No. CV 21-119 
(RDM), 2022 WL 971067, at *21 (D.D.C. Mar. 30, 2022) (quoting Postpone, Merriam-
Webster Dictionary Online, https://www.merriam-webster.com/dictionary/ 
postpone); see also Postpone, Oxford English Dictionary Online (last visited Apr. 19, 
2022) (“To put off to the future; to arrange for (an event, etc.) to take place at a later time 
. . . .”). But once an agency action “has taken effect,” the court “can no longer ‘put off’ 
the effective date.” Ctr. for Biological Diversity, 2022 WL 971067, at *21.  
Thus, section 705 does not permit a court “to suspend [an agency action] that has 
already taken effect.” Nat. Res. Def. Council v. U.S. Dep’t of Energy, 362 F. Supp. 3d 126, 
151 (S.D.N.Y. 2019); see, e.g., Becerra v. U.S. Dep’t of Interior, 276 F. Supp. 3d 953, 963–64 
(N.D. Cal. 2017) (5 U.S.C. § 705 allows “postpone[ment] of the effective date of a not yet 
effective [agency action], pending judicial review.” (quoting Safety–Kleen Corp. v. EPA, 
1996 U.S. App. LEXIS 2324, at *2 (D.C. Cir. Jan. 19, 1996)). Plaintiffs’ attempt, in this 
case, to “suspend” a portion of the Pfizer EUA that has been effective for nearly six 
months runs “contrary to the plain language of the statute.” State of Cal. v. U.S. Bureau of 
Land Mgmt., 277 F. Supp. 3d 1106, 1119 (N.D. Cal. 2017). 
Second, rather than utilize 5 U.S.C. § 705 “to preserve status” pending review, 
Plaintiffs actually seek to alter the status quo. “At the time [P]laintiff[s] filed” the 
Complaint on January 24, 2022, “the status quo was that” the Pfizer EUA for children 
aged 5 to 11 had been in effect since October 29, 2021. Tok Air Serv., 2021 WL 3271342, at 
*7. “By asking this court to” suspend that long-effective EUA, Plaintiffs are “asking the 
court to change the status quo.” Id. But section 705 does not authorize the Court to 
“belatedly disrupt[]” the status quo, only to maintain it. State of Cal., 277 F. Supp. 3d at 
1120; see Nishihata, 2021 WL 4476750, at *6 (finding § 705 inapplicable because the 
requested relief “would not maintain the status quo, but would instead alter it”) 
(emphasis in original); Boansi v. Johnson, No. 2:14-CV-47-BO, 2014 WL 6883133, at *2 
(E.D.N.C. Dec. 3, 2014) (same). 
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Furthermore, suspension of the Pfizer EUA is not “necessary and appropriate . . . to 
preserve” Plaintiffs’ “rights” pending review. 5 U.S.C. § 705. Plaintiffs make cursory 
mention of the “rights of informed consent, medical freedom, and personal autonomy.” 
Stay Mem. 17. But no Plaintiff claims to lack sufficient information to make a choice 
about the Pfizer EUA vaccine. See Holland Decl., ECF No. 14-1, at 22–23; Dietrich Decl., 
ECF No. 14-1, at 25–27; Else Decl., ECF No. 14-1, at 29–30. They simply oppose it. And 
Plaintiffs cite nothing that would deprive them of their option to decline administration 
of the vaccine. See 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III); Ex. 2, Burk Decl., ECF No. 18-3 
(“Fact Sheet”), at 5 (“there is an option to accept or refuse receiving the vaccine”); Miller 
ex rel. Miller v. HCA, Inc., 118 S.W.3d 758, 766 (Tex. 2003) (parent’s right “not to consent” 
to their children’s medical care); Stay Mem. 13 (acknowledging Texas governor’s 
“executive order prohibiting COVID-19 vaccine mandates”). Indeed, Dietrich and Else 
have freely “declined” invitations for their children to receive the EUA vaccine. Else 
Decl., ECF No. 14-1, at 29; see Dietrich Decl., ECF No. 14-1, at 26. Because none of 
Plaintiffs’ rights are in need of preservation, 5 U.S.C. § 705 does not “provide[] the 
authority for the Court to order the relief Plaintiffs seek here.” Nishihata, 2021 WL 
4476750, at *6; see Comprehensive Cmty. Dev. Corp. v. Sebelius, No. 12 CIV. 0776 PAE, 2012 
WL 738185, at *8 (S.D.N.Y. Mar. 7, 2012) (declining to order relief under 5 U.S.C. § 705, 
in part, because “it is unclear how the” requested relief “would assist” plaintiff). 
II. Plaintiffs also have not clearly established any factor required for relief 
Even if 5 U.S.C. § 705 could authorize a judicial suspension of the Pfizer EUA in 
effect since last October, Plaintiffs still must clearly satisfy every required factor under 
the preliminary-injunction standard. See, e.g., Big Tyme Invs., 985 F.3d at 464. They fall 
far short of that mark. 
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A. Plaintiffs are not likely to establish jurisdiction, much less succeed on the 
merits 
No court may issue a preliminary injunction without first determining “whether it 
ha[s] jurisdiction.” Enter. Int’l, Inc. v. Corporacion Estatal Petrolera Ecuatoriana, 762 F.2d 
464, 471 (5th Cir. 1985); Nat’l Football League Players Ass’n v. Nat’l Football League, 874 
F.3d 222, 229 (5th Cir. 2017) (vacating preliminary injunction because district court 
“lacked subject matter jurisdiction when [injunction] issued”). As explained in 
Defendants’ pending motion to dismiss, the Court lacks jurisdiction because no Plaintiff 
has standing and no waiver of sovereign immunity applies. See Defs.’ Mot. 6–15. 
Plaintiffs’ stay motion does nothing to refute the sovereign immunity bar to their 
claims, while underscoring their lack of standing. 
Dietrich and Else supposedly fear “an ‘imminent risk of immediate harm’ to their 
children if they were to receive the Pfizer vaccine.” Defs.’ Mot. 7 (quoting Compl. ¶¶ 6–
7). Yet consistent with the Pfizer EUA’s voluntary nature, both have simply “declined” 
to vaccinate their children. Else Decl., ECF No. 14-1, at 29; see Dietrich Decl., ECF No. 
14-1, at 26. Plaintiffs also acknowledge that the governor of Texas has issued an 
“executive order prohibiting COVID-19 vaccine mandates.” Stay Mem. 13. Against 
those facts, they offer only speculation that the law might change and a vaccine 
mandate “take hold in Texas,” or that an unvaccinated child might somehow face 
differential treatment in various settings. Dietrich Decl., ECF No. 14-1, at 27; see also infra 
p. 10 (addressing Plaintiffs’ speculation about hypothetical, future coercion). Such 
“remote possibilit[ies] of harm” fail standing’s “imminence requirement,” Tenth St. 
Residential Ass’n v. City of Dall., 968 F.3d 492, 501 (5th Cir. 2020), and, in any event, 
would be traceable to independent third-party actions, not FDA, see Defs.’ Mot. 9. 
Otherwise, Dietrich and Else reiterate their disagreement with “pro-vaccine 
marketing” and “recommendations” by physicians, schools, “big box stores,” and 
various media outlets. Dietrich Decl., ECF No. 14-1, at 26; Else Decl., ECF No. 14-1, at 
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29. But their mere exposure to disagreeable information in the world is neither a 
concrete nor a cognizable injury. See Defs.’ Mot. 9; see also Hein v. Freedom From Religion 
Found., 551 U.S. 587, 634 (2007) (Scalia, J., concurring) (“mental angst” generally not a 
cognizable injury); MainStreet Org. of Realtors v. Calumet City, 505 F.3d 742, 745 (7th Cir. 
2007). Also, the allegedly offensive messages appear to be those of independent third 
parties—not FDA—which defeats standing. See Defs.’ Mot. 9. 
Although CHD must show a “concrete and demonstrable injury to [its] activities,” 
Havens Realty Corp. v. Coleman, 455 U.S. 363, 379 (1982), its president and general 
counsel provides nothing more than a “[t]hreadbare recital[] of the” standard for 
organizational standing, Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009); see Holland Decl., ECF 
No. 14-1, at 23 (group “has incurred substantial costs from the diversion of essential 
resources”). And the only somewhat specific cost mentioned in the briefing—“the 
marketing and expense of this action,” Stay Mem. 19—is “insufficient to impart 
standing upon the organization” under binding precedent, Ass’n for Retarded Citizens of 
Dall. v. Dall. Cty. Mental Health & Mental Retardation Ctr., 19 F.3d 241, 244 (5th Cir. 1994); 
see Steel Co. v. Citizens for a Better Env’t, 523 U.S. 83, 107 (1998) (“[A] plaintiff cannot 
achieve standing to litigate a substantive issue by bringing suit for the cost of bringing 
suit.”); Defs.’ Mot. 10–11. 
Even if Plaintiffs could show standing and an applicable waiver of sovereign 
immunity, they remain unlikely to succeed on the merits of their APA claim. The 
motion advances only three merits arguments: (1) no “emergency” exists to justify the 
Pfizer EUA; (2) the EUA denies “the informed consent rights of children and their 
parents”; and (3) the EUA somehow “chang[ed] the definition of vaccine.” Stay Mem. 
16. The first and third arguments are addressed and refuted in Defendants’ motion to 
dismiss. See Defs.’ Mot. 16–18. The second argument too is meritless. Contrary to 
Plaintiffs’ naked assertion, FDA publicly explained its evaluation of the benefits and 
risks (both known and unknown) of the Pfizer vaccine, as well as an individual’s option 
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to “refuse administration of the product.” 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(II)–(III). 
Compare Stay Mem. 17, with January Letter, and EUA Mem., ECF No. 1, at 178–225, and 
Fact Sheet 5. Plaintiffs may be opposed to the Pfizer EUA vaccine, but they do not 
purportedly lack sufficient information to make a choice about it. See, e.g., Else Decl., 
ECF No. 14-1, at 30 (“I have been following much of the scientific evidence and research 
about Covid-19, available treatments for it, and the emergence of the new Covid-19 
shots from early on during the pandemic.”).  
Preliminary relief “should never issue if there is no chance that the movant will 
eventually prevail on the merits.” State of Tex. v. Seatrain Int’l, S.A., 518 F.2d 175, 180 (5th 
Cir. 1975). Lacking standing, an applicable sovereign-immunity waiver, and a plausible 
APA claim, Plaintiffs cannot prevail on the merits. That failure alone “is fatal to [their] 
claim for” relief under 5 U.S.C. § 705, so the Court “need not address the three 
remaining prongs of the test.” Lake Charles Diesel, 328 F.3d at 203.  
B. Plaintiffs have not convincingly shown any irreparable injury 
Should the Court reach the irreparable injury factor, it too is unmet. “[I]rreparable 
harm must be proven separately and convincingly.” White v. Carlucci, 862 F.2d 1209, 
1212 (5th Cir. 1989). A mere “possibility of irreparable harm,” Winter, 555 U.S. at 22, and 
a “[s]peculative injury [are] not sufficient,” Holland Am. Ins. Co. v. Succession of Roy, 777 
F.2d 992, 997 (5th Cir. 1985). Plaintiffs fail to convincingly show they will suffer any 
irreparable harm before “a judgment is rendered.” Nichols v. Alcatel USA, Inc., 532 F.3d 
364, 378 (5th Cir. 2008); see 5 U.S.C. § 705 (authorizing relief only when “necessary to 
prevent irreparable injury . . . pending conclusion of the review proceedings”). 
For starters, “[a] delay in seeking a preliminary injunction of even only a few 
months . . . militates against a finding of irreparable harm.” Wreal, LLC v. Amazon.com, 
Inc., 840 F.3d 1244, 1248 (11th Cir. 2016). It “is well-established that” such a delay 
demonstrates “there is no apparent urgency to the request for injunctive relief.” 
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Gonannies, Inc. v. Goupair.Com, Inc., 464 F. Supp. 2d 603, 609 (N.D. Tex. 2006) (quotation 
omitted). Here, Plaintiffs waited 169 days—nearly 6 months—after the Pfizer EUA 
became effective for children aged 5 to 11 before filing this motion. Because they offer 
no “justification for the delay,” Wreal, 840 F.3d at 1248, it alone precludes any finding of 
irreparable harm, see, e.g., id. at 1248–49 (affirming denial of preliminary injunction 
where plaintiff “failed to offer any explanation for its five-month delay”); Boire v. Pilot 
Freight Carriers, Inc., 515 F.2d 1185, 1193 (5th Cir. 1975) (same, where party “waited 
three months before petitioning the district court for temporary relief”). 
In any event, “an extraordinary remedy,” Winter, 555 U.S. at 24, is not “necessary,” 
5 U.S.C. § 705, to address Plaintiffs’ asserted harms. “[M]ost bothersome of all,” 
Plaintiffs declare, “is the constant discussion about the Covid-19 shots in TV ads, over 
loud speakers in big box stores,” as well as “on the radio” and television. Else Decl., 
ECF No. 14-1, at 29; see Dietrich Decl., ECF No. 14-1, at 26. Far from irreparable, 
Plaintiffs “may effectively avoid further bombardment of their sensibilities simply by 
averting their eyes” and ears. Consol. Edison Co. of N.Y. v. Pub. Serv. Comm’n of N.Y., 447 
U.S. 530, 542 (1980) (internal quotation omitted). Speculation and “unfounded fear[s],” 
Holland Am., 777 F.2d at 997, about future “pressure and coercion to receive the vaccine 
to participate in society,” Stay Mem. 13, also will not suffice. Nor does “the marketing 
and expense of this action” to CHD, Stay Mem. 19, because “litigation expense, even 
substantial and unrecoupable cost, does not constitute irreparable injury,” Renegotiation 
Bd. v. Bannercraft Clothing Co., 415 U.S. 1, 24 (1974). “[R]elief under [section] 705, at a 
minimum, requires a showing of ‘irreparable harm,’” but Plaintiffs have “not made that 
showing here.” Cigar Ass’n of Am. v. U.S. FDA, No. 1:16-CV-01460 (APM), 2020 WL 
5231335, at *3 (D.D.C. Sept. 2, 2020). 
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C. The public interest does not favor depriving all parents of the choice to 
vaccinate their children against COVID-19 
Lastly, “courts of equity should pay particular regard for the public consequences 
in employing the extraordinary remedy of injunction.” Winter, 555 U.S. at 24. “In 
litigation involving the administration of regulatory statutes designed to promote the 
public interest,” like 21 U.S.C. § 360bbb-3, “this factor necessarily becomes crucial.” Va. 
Petroleum Jobbers Ass’n v. Fed. Power Comm’n, 259 F.2d 921, 925 (D.C. Cir. 1958). 
Plaintiffs solely argue that “[i]t is in the public interest that those seeking vaccines 
receive accurate, truthful, complete information, and that they give informed consent or 
informed refusal.” Stay Mem. 19–20. FDA does not disagree. The agency undertook 
great efforts to analyze the benefits and risks of the Pfizer vaccine, and then publish in 
detail the basis for its findings on its website. See January Letter; EUA Mem., ECF No. 1, 
at 178–225. It also required that a fact sheet be made available to all potential vaccine 
recipients and their caregivers, which summarizes the relevant information, explains 
how to learn more, and ultimately confirms that “there is an option to accept or refuse 
receiving the vaccine.” See generally Fact Sheet. In short, FDA has taken significant 
measures to ensure American parents may make a fully informed choice for their 
children about vaccination. 
Declining to vaccinate their children, Plaintiffs face no “threatened injury” from the 
Pfizer EUA’s existence. Valley v. Rapides Par. Sch. Bd., 118 F.3d 1047, 1051 (5th Cir. 1997). 
Their non-injury does not “outweigh[] any harm that may result from the” suspension 
of the Pfizer EUA, and the relief they seek would in fact “undermine the public 
interest.” Id. Suspension of the Pfizer EUA would deny all American parents the ability 
to choose whether to vaccinate their children. See Bianco v. Globus Med., Inc., No. 2:12-
CV-00147-WCB, 2014 WL 1049067, at *12 (E.D. Tex. Mar. 17, 2014) (finding, on request 
to remove medical “products from the market,” that “the public interest factor weighs 
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significantly in favor of denying injunctive relief” so physicians have the “products 
available to them as an option”). 
While Plaintiffs’ children “may remain unvaccinated at their own risk, the balance 
of equities and public interest do not require [D]efendants to allow [P]laintiffs to spread 
that risk” to all families. Bauer v. Summey, No. 2:21-CV-02952-DCN, 2021 WL 4900922, at 
*19 (D.S.C. Oct. 21, 2021). The Pfizer EUA “promot[es] a strong public interest—
combatting the spread of COVID-19.” Id.; see Roman Cath. Diocese of Brooklyn v. Cuomo, 
141 S. Ct. 63, 67 (2020) (per curiam) (“Stemming the spread of COVID–19 is 
unquestionably a compelling interest.”). That interest is best served by maintaining the 
status quo—i.e., each parent enjoys the “option to accept or refuse” for their child to 
receive the Pfizer EUA vaccine. 
CONCLUSION 
For the foregoing reasons, the Court should deny Plaintiffs’ motion to “suspend” 
the Pfizer EUA pending judicial review. 
 
 
April 29, 2022 
 
OF COUNSEL: 
 
DANIEL BARRY 
Acting General Counsel 
U.S. Department of Health and Human 
Services 
 
MARK RAZA 
Chief Counsel 
 
WENDY VICENTE 
Acting Deputy Chief Counsel, Litigation 
 
 
 
Respectfully submitted, 
 
BRIAN M. BOYNTON 
Principal Deputy Assistant Attorney 
General 
 
ARUN G. RAO 
Deputy Assistant Attorney General 
  
GUSTAV W. EYLER 
Director 
 
HILARY K. PERKINS 
Assistant Director 
 
 
 
Case 6:22-cv-00093-ADA-DTG   Document 19   Filed 04/29/22   Page 14 of 15

 
13 
 
JAMES ALLRED 
Associate Chief Counsel 
Office of the Chief Counsel 
U.S. Food and Drug Administration 
10903 New Hampshire Ave. 
White Oak 31, Room 4564 
Silver Spring, MD  20993-0002 
/s/ James W. Harlow 
JAMES W. HARLOW 
Senior Trial Attorney 
Consumer Protection Branch 
Civil Division 
U.S. Department of Justice 
P.O. Box 386 
Washington, DC  20044-0386 
(202) 514-6786 
(202) 514-8742 (fax) 
james.w.harlow@usdoj.gov 
 
 
Case 6:22-cv-00093-ADA-DTG   Document 19   Filed 04/29/22   Page 15 of 15

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