Reply in support of motion to dismiss the First Amended Complaint — Children's Health Defense v. FDA (W.D. Tex.)

Record facts

U.S. District Court for the Western District of Texas (Waco Division) · No. 6:22-cv-00093-ADA-DTG · Doc. 31 · 2022-09-16 · Docket on CourtListener

Full text

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 
Reply in Support of Defendants’ Motion to Dismiss the First Amended Complaint 
 
 
 
  
Case 6:22-cv-00093-ADA-DTG   Document 31   Filed 09/16/22   Page 1 of 13

 
 
TABLE OF CONTENTS 
INTRODUCTION ............................................................................................................................... 1 
ARGUMENT ..................................................................................................................................... 2 
I. 
Plaintiffs’ jurisdictional burden remains unmet .......................................................... 2 
A. 
Plaintiffs continue to lack standing ......................................................................... 2 
B. 
Sovereign immunity continues to bar Plaintiffs’ claims ...................................... 7 
II. 
On their merits, Plaintiffs’ claims are still implausible .............................................. 8 
III.  The Court should not grant further leave to amend ................................................... 9 
CONCLUSION ................................................................................................................................ 10 
Case 6:22-cv-00093-ADA-DTG   Document 31   Filed 09/16/22   Page 2 of 13

 
 
INTRODUCTION 
In May 2022, Defendants’ reply in support of dismissing the original complaint 
opened by highlighting “three fatal flaws.” First, “no Plaintiff possesses standing” 
because Plaintiffs alleged nothing more than a policy disagreement with the U.S. Food 
and Drug Administration (“FDA”) about the emergency use authorization (“EUA”) of a 
COVID-19 vaccine for children. Second, Plaintiffs “ignore the language and structure of 
21 U.S.C. § 360bbb-3, which fits the exemptions for Administrative Procedure Act 
(“APA”) review in 5 U.S.C. § 701(a)(1)–(2),” so “no waiver of sovereign immunity 
applies to” Plaintiffs’ claims. Third, Plaintiffs “cannot muster an adequate legal and 
factual foundation for their claims,” as required under the Federal Rule of Civil 
Procedure 12(b)(6) standard. Days later, the Court found no need to proceed beyond the 
first fatal flaw—lack of standing—and dismissed the complaint. 
Despite ample notice to Plaintiffs and an opportunity to amend their complaint, the 
“three fatal flaws” identified in May remain unredressed. Plaintiffs still have not shown 
a cognizable injury fairly traceable to the challenged COVID-19 vaccine EUAs that 
suffices for standing. Plaintiffs still fail to identify an applicable waiver of sovereign 
immunity and to engage with the text of 21 U.S.C. § 360bbb-3. And Plaintiffs still fail to 
allege the factual and legal predicates for a plausible APA claim.  
The Court should once again grant Defendants’ motion to dismiss. The Court 
should also deny Plaintiffs further leave to amend. After two inadequate attempts to 
plead a justiciable case, Plaintiffs do not deserve a third. 
Case 6:22-cv-00093-ADA-DTG   Document 31   Filed 09/16/22   Page 3 of 13

 
2 
 
ARGUMENT 
I. 
Plaintiffs’ jurisdictional burden remains unmet 
A. Plaintiffs continue to lack standing 
Standing has been—and continues to be—a threshold requirement that Plaintiffs 
cannot satisfy. The Court dismissed the original complaint “due to lack of standing.” 
May 21, 2022 Text Order. Now, “questioned” about their standing to pursue the 
Amended Complaint, Plaintiffs still “must explain how the elements essential to 
standing are met.” Va. House of Delegates v. Bethune-Hill, 139 S. Ct. 1945, 1951 (2019); see 
Defs.’ Mot., ECF No. 29, at 6–13. Plaintiffs’ Opposition confirms that they cannot do so. 
The individual plaintiffs begin by arguing that their children “are directly 
threatened by” the challenged EUAs. Pls.’ Opp’n, ECF No. 30, at 13. A bare threat of 
harm is an “abstract injury” that is “insufficient to confer standing.” Legacy Cmty. Health 
Servs., Inc. v. Smith, 881 F.3d 358, 370 (5th Cir. 2018) (cleaned up). The individual 
plaintiffs must “clearly allege facts” showing that their children will suffer a “concrete 
and particularized injury,” Spokeo, Inc. v. Robins, 578 U.S. 330, 338–39 (2016) (cleaned 
up), and that injury must be imminent, i.e., occurring within “a short timeframe,” Attala 
Cnty., Miss. Branch of NAACP v. Evans, 37 F.4th 1038, 1043 (5th Cir. 2022). None of the 
threatened harms mentioned in Plaintiffs’ Opposition meets that standard. 
By simply declining to consent to the administration of a COVID-19 EUA vaccine 
to their children, the individual plaintiffs have precluded any injury from these 
vaccines. See Defs.’ Mot. 7. Although Plaintiffs worry about the “threat of being pushed 
out of society” and “the risk of expanding vaccine mandates,” Pls.’ Opp’n 13, they cite 
no mandates, either in effect or in the offing, that could apply to their children and 
override their parental decisions. Undeniably, neither of the challenged EUAs “compels 
any individual to receive the vaccine or any parent to consent to administration to their 
child.” Defs.’ Mot. 7. And none of the states where Plaintiffs reside have imposed an 
Case 6:22-cv-00093-ADA-DTG   Document 31   Filed 09/16/22   Page 4 of 13

 
3 
 
applicable COVID-19 vaccination mandate—a point they do not contest. See id. 8–10 
(discussing state laws). 
Instead, the Shours hypothesize that they “could be stationed in a state”—location 
unknown—“that implements strict mandates”—the terms of which are unknown—
“and, as a result, [their] children could face discrimination”—the nature and source of 
which are unknown. Pls.’ Opp’n 14 (emphases added). Deborah Else and Sacha Dietrich 
“fear that their child[ren] may be vaccinated without their consent” through the 
connivance of an unknown individual and an unknown medical provider’s 
contravention of Texas law. See id. 14–15. Similarly, Else and Dietrich fear their children 
might suffer unforeseeable medical complications and be “denied life-saving treatment” 
by an unknown health care provider under an unknown policy. Id. 14. Critically, 
Plaintiffs allege no facts demonstrating that these events, all of which are also 
contingent on the independent actions of unknown third parties and therefore not 
traceable to Defendants, “will occur to one of” Plaintiffs’ children imminently. Attala 
Cnty., 37 F.4th at 1043; see Spokeo, 578 U.S. at 339; Clapper v. Amnesty Int’l USA, 568 U.S. 
398, 414 (2013) (“We decline to abandon our usual reluctance to endorse standing 
theories that rest on speculation about the decisions of independent actors.”). And 
neither “subjective fear[s],” Clapper, 568 U.S. at 418, nor “unadorned speculation” 
suffices for standing, Simon v. E. Ky. Welfare Rights Org., 426 U.S. 26, 44 (1976). 
The individual plaintiffs also are upset that their children are exposed to messaging 
in favor of the EUA vaccines. See Pls.’ Opp’n 13. But they identify no “close historical or 
common-law analogue for their asserted injury,” as necessary for an intangible injury. 
TransUnion LLC v. Ramirez, 141 S. Ct. 2190, 2204 (2021). Indeed, they allege nothing 
more “than the psychological consequence presumably produced by observation of 
conduct with which one disagrees,” which “is not an injury sufficient to confer standing 
under Art. III.” Valley Forge Christian Coll. v. Ams. United for Separation of Church & State, 
Inc., 454 U.S. 464, 485 (1982); see, e.g., Defs.’ Mot. 6 n.2 (citing cases). Furthermore, they 
Case 6:22-cv-00093-ADA-DTG   Document 31   Filed 09/16/22   Page 5 of 13

 
4 
 
identify as the speakers those “not before the court,” Simon, 426 U.S. at 41–42, including 
“school administrators,” “pediatricians,” as well as “the media and other children,” Pls.’ 
Opp’n 13. Even if cognizable, an injury attributable to independent speakers cannot 
support standing to challenge the COVID-19 vaccine EUAs. 
The individual plaintiffs next assert an inability “to rely on any future FDA 
attestations of safety and effectiveness.” Pls.’ Opp’n 15. But a valid loss-of-confidence 
theory still requires a “real and immediate threat of future harm.” Funeral Consumers 
All., Inc. v. Serv. Corp. Int’l, 695 F.3d 330, 343 (5th Cir. 2012). And the Amended 
Complaint’s “conclusory allegation[s]” about a loss of confidence are “not sufficient.” 
Dragoslavic v. Ace Hardware Corp., 274 F. Supp. 3d 578, 583 (E.D. Tex. 2017); see Am. 
Compl., ECF No. 26, at ¶ 95. No plaintiff alleges they will refrain from using any FDA-
approved product in the future. See Funeral Consumers All., 695 F.3d at 342–43 (no 
standing when plaintiffs did not establish “a real and immediate threat of future harm” 
from future product purchases); Brawley v. Bath & Body Works, LLC, No. 3:18-CV-02098-
S, 2019 WL 7945655, at *3 (N.D. Tex. Sept. 25, 2019).1 Nor do Plaintiffs explain how 
court-ordered relief about the challenged EUAs could redress their reduced confidence 
in “future FDA attestations of safety and effectiveness” for other products. Pls.’ Opp’n 
15; see California v. Texas, 141 S. Ct. 2104, 2115 (2021) (“To determine whether an injury is 
redressable, a court will consider the relationship between ‘the judicial relief requested’ 
and the ‘injury’ suffered.” (quoting Allen v. Wright, 468 U.S. 737, 753 n.19 (1984))). 
Ultimately, Plaintiffs’ theory amounts to an impermissible attempt to “manufacture 
standing merely by inflicting harm on themselves based on their fears of hypothetical 
future harm that is not certainly impending.” Clapper, 568 U.S. at 416; see Food & Water 
 
1 That omission fully distinguishes this case from Davidson v. Kimberly-Clark Corp., 
889 F.3d 956 (9th Cir. 2018), which turned on the court’s finding that the plaintiff 
“sufficiently alleges that she would purchase” the relevant product in the future, id. at 
970 n.5, 971. 
Case 6:22-cv-00093-ADA-DTG   Document 31   Filed 09/16/22   Page 6 of 13

 
5 
 
Watch, Inc. v. Vilsack, 808 F.3d 905, 919 (D.C. Cir. 2015) (holding that plaintiffs’ desire to 
avoid certain poultry products due to “their subjective fear” about the adequacy of 
government inspection “does not give rise to standing”) (quotation omitted). 
Because none of the individual plaintiffs established their standing, Children’s 
Health Defense (“CHD”) necessarily lacks associational standing. Pls.’ Opp’n 10; see Ctr. 
for Biological Diversity v. U.S. EPA, 937 F.3d 533, 536 (5th Cir. 2019); Defs.’ Mot. 11.  
CHD’s bid for organizational standing fares no better. CHD continues to neglect 
the Fifth Circuit’s clear, binding standards for organizational injuries. To reiterate: 
“[A]n organization does not automatically suffer a cognizable injury in fact by diverting 
resources in response to a defendant’s conduct.” El Paso Cnty. v. Trump, 982 F.3d 332, 
343 (5th Cir. 2020); see Defs.’ Mot. 11–12. The organization must “demonstrate[] that the 
diversion of resources . . . concretely and ‘perceptibly impaired’” its “ability to carry out 
its purpose.” NAACP v. City of Kyle, 626 F.3d 233, 239 (5th Cir. 2010) (quoting Havens 
Realty Corp. v. Coleman, 455 U.S. 363, 379 (1982)). A “vague, conclusory assertion” about 
“divert[ed] resources is insufficient to establish” that the challenged action “‘perceptibly 
impaired’ the organization’s ability to carry out its mission.” El Paso, 982 F.3d at 344. 
Plaintiffs’ Opposition describes how CHD “devoted resources” to issues related to 
the challenged EUAs “over the past 18 months,” including research, member 
communication, and public outreach. Pls.’ Opp’n 9. But fatally, CHD cites nothing in 
the Amended Complaint, or in any other evidence properly before the Court, plausibly 
showing a “diversion of resources” that “concretely and ‘perceptibly impaired’” its 
“ability to carry out its purpose.” City of Kyle, 626 F.3d at 239 (quoting Havens Realty 
Corp., 455 U.S. at 379). For instance, it still “has not ‘identified any specific projects’ it 
‘had to put on hold or otherwise curtail in order to respond to the’ EUAs.” Defs.’ Mot. 
12 (quoting City of Kyle, 626 F.3d at 238). And rather than show how CHD’s “reaction to 
the allegedly unlawful conduct . . . differ[ed] from its routine activities,” El Paso Cnty., 
982 F.3d at 344, Plaintiffs’ Opposition confirms that advocacy about “public health 
Case 6:22-cv-00093-ADA-DTG   Document 31   Filed 09/16/22   Page 7 of 13

 
6 
 
policies and practices that are harming our children,” like that CHD has undertaken 
based on its views of the EUA vaccines, is its mission, Pls.’ Opp’n 10–11. Because CHD’s 
resources are not being diverted from its core mission, it cannot claim organizational 
standing. See Tenth St. Residential Ass’n v. City of Dallas, 968 F.3d 492, 500 (5th Cir. 2020) 
(no organizational standing when group’s “overall mission . . . is aligned with and 
furthered by its efforts” in response to challenged conduct).  
The other two purported injuries to CHD mentioned in Plaintiffs’ Opposition may 
be readily dispatched. FDA did not “ignor[e] . . . CHD’s Citizen Petition,” Pls.’ Opp’n 3, 
7; to the contrary, the agency responded in great detail, see Defs.’ Mot. 4, 17; ECF No. 26-
3, at 62–114 (FDA response). CHD identifies no issue that went unaddressed in FDA’s 
response, let alone an injury based on FDA’s response traceable to the challenged EUAs, 
so CHD’s undeveloped theory of injury falls short. See California, 141 S. Ct. at 2119. 
Likewise, CHD’s barebones assertion that Defendants “demand[ed] major social media 
platforms prevent [CHD] from reaching the public” and fundraising, Am. Compl. ¶ 
162; see Pls.’ Opp’n 8, does not plausibly allege a concrete and particularized injury in 
fact. Nor would any independent actions by social media companies regarding CHD’s 
accounts be fairly traceable to FDA’s issuance of the challenged EUAs. See Ass’n of Am. 
Physicians & Surgeons, Inc. v. Schiff, 23 F.4th 1028, 1033 (D.C. Cir. 2022) (holding that 
organization lacked standing to sue congressman because “any actions limiting the 
accessibility of the Association’s web content were not taken by Representative Schiff; 
instead, as the amended complaint acknowledges, they were taken by independent 
third parties Facebook, Google, Amazon, Twitter, and YouTube”). 
Equally deficient is CHD’s attempt to assert the rights of “children between the 
ages of six months and 11 years of age under Texas state conservatorship, who are not 
protected by a parent or guardian.” Pls.’ Opp’n 10. This assertion is not contained in the 
Amended Complaint and thus is not properly before the court. See Cont’l Auto. Sys., Inc. 
v. Avanci, LLC, 27 F.4th 326, 333 n.9 (5th Cir. 2022) (“[I]t is axiomatic that a complaint 
Case 6:22-cv-00093-ADA-DTG   Document 31   Filed 09/16/22   Page 8 of 13

 
7 
 
cannot be amended by briefs in opposition to a motion to dismiss.” (quoting In re Enron 
Corp. Sec., Derivative & ERISA Litig., 761 F. Supp. 2d 504, 566 (S.D. Tex. 2011))). In any 
event, CHD lacks third-party standing because it has suffered no injury itself and has 
“no relationship at all” with these children. Kowalski v. Tesmer, 543 U.S. 125, 129–31 
(2004); see Vote.Org v. Callanen, 39 F.4th 297, 304 (5th Cir. 2022). 
As before, see Defs.’ Reply, ECF No. 23, at 6, the out-of-circuit decisions Plaintiffs 
identify cannot salvage their standing. The Court’s “mandate [is] to follow the dictates 
of controlling Fifth Circuit authority,” including the cases discussed by FDA, which 
directly speak to organizational standing requirements. Matamoros v. Ysleta Indep. Sch. 
Dist., 916 F. Supp. 2d 723, 729 (W.D. Tex. 2012); see id. (declining to “forage outside the 
Fifth Circuit . . . when the Fifth Circuit has spoken to the issue on multiple occasions”). 
In any event, the cases Plaintiffs cite, see Pls.’ Opp’n 6, 8, are irrelevant to CHD’s 
theories of organizational standing, see, e.g., Pub. Citizen v. Foreman, 631 F.2d 969, 974 
n.12 (D.C. Cir. 1980) (associational standing based on injury to individual members); 
Am. Acad. of Pediatrics v. FDA, 379 F. Supp. 3d 461, 477 (D. Md. 2019) (evaluating 
organization’s injury “due to agency action limiting their access to . . . information” 
guaranteed by statute). 
Ultimately, the Amended Complaint alleges no more than a “setback to [CHD’s] 
abstract social interests,” which cannot confer standing. Havens Realty Corp., 455 U.S. at 
379. Like the individual plaintiffs, CHD lacks standing and the case should be 
dismissed. 
B. Sovereign immunity continues to bar Plaintiffs’ claims 
Apart from Plaintiffs’ inability to establish standing, sovereign immunity also 
imposes a jurisdictional bar. See Defs.’ Mot. 13–15. As Defendants have explained, the 
challenged EUAs fall within both of the exceptions to the APA’s waiver of sovereign 
immunity in 5 U.S.C. § 701(a)(1) and (a)(2). See id. Plaintiffs respond only by agreeing 
Case 6:22-cv-00093-ADA-DTG   Document 31   Filed 09/16/22   Page 9 of 13

 
8 
 
that 21 U.S.C. § 360bbb-3 grants “discretion to [FDA] and the Secretary of Health and 
Human Services” and generally asserting that FDA’s premarket approval decisions are 
not traditionally committed to agency discretion. Pls.’ Opp’n 17. Fatally, they eschew 
any analysis of the text, structure, purpose, and history of the statutory provision 
specific to EUAs, which FDA showed to explicitly preclude judicial review here, see 
Defs.’ Mot. 13–15, as courts continue to recognize, see Antunes v. Rector & Visitors of the 
Univ. of Va., No. 3:21-CV-00042, 2022 WL 4134770, at *4–5 (W.D. Va. Sept. 12, 2022) 
(“Plain statutory language dictates that the HHS’ vaccine emergency use authorization 
is ‘committed to agency discretion’” and therefore exempt from the APA’s waiver of 
sovereign immunity); Doe #1-#14 v. Austin, 572 F. Supp. 3d 1224, 1237–38 (N.D. Fla. 
2021) (denying motion for preliminary injunction and observing that “the statute at 
issue here . . . explicitly says that EUA decisions ‘are committed to agency discretion’”). 
Plaintiffs’ fallback argument under an unidentified “pre-APA review” standard, 
Pls.’ Opp’n 16, is most generously read as an impermissible attempt to introduce an 
ultra vires claim not pleaded in the Amended Complaint, see Cont’l Auto. Sys., 27 F.4th at 
333 n.9. The Court may not consider these new allegations “made in [the] opposition to 
the motion to dismiss.” Id. 
II. On their merits, Plaintiffs’ claims are still implausible 
Even if Plaintiffs had met their jurisdictional burden, they still face dismissal 
because their claims are implausible. The Amended Complaint must contain enough 
“well-pleaded factual allegations,” Ashcroft v. Iqbal, 556 U.S. 662, 679 (2009), to 
“plausibly establish that” issuance of the challenged EUAs for children aged 6 months 
through 11 years was “arbitrary and capricious,” Blanchett v. DeVos, 490 F. Supp. 3d 26, 
32 (D.D.C. 2020); see Defs.’ Mot. 16. In its motion to dismiss, FDA explained why each 
argument advanced in the Amended Complaint lacked adequate factual and legal 
support. See Defs.’ Mot. 16–20.  
Case 6:22-cv-00093-ADA-DTG   Document 31   Filed 09/16/22   Page 10 of 13

 
9 
 
Plaintiffs generally maintain that FDA’s consideration of the issues was inadequate 
but do not delve into specific flaws. See Pls.’ Opp’n 19. This is no response to FDA’s 
previous refutation of each purported inadequacy through citation to agency 
documents that Plaintiffs themselves attached to the Amended Complaint. See Defs.’ 
Mot. 16–20. FDA also specifically rebutted the allegation that no emergency warranted 
the issuance of the challenged EUAs. Compare Pls.’ Opp’n 19, with Defs.’ Mot. 16–17. In 
addition, Plaintiffs do not dispute FDA’s position that any novel arguments, which 
were not previously presented to the agency or raised in the record, have been waived. 
See Defs.’ Mot. 19–20. Thus, Plaintiffs’ claims rest upon invalid legal theories and 
insufficient factual support. 
III. The Court should not grant further leave to amend 
If the Court dismisses the Amended Complaint, it should not grant Plaintiffs 
another opportunity to amend. Plaintiffs’ “ability to amend their pleadings is by no 
means unlimited.” Gonzales v. Columbia Hosp., 207 F. Supp. 2d 570, 573 (N.D. Tex. 2002). 
Among other reasons, the Court may deny further leave to amend due to the “repeated 
failure to cure deficiencies by amendments previously allowed” and the “futility of 
amendment.” Foman v. Davis, 371 U.S. 178, 182 (1962). Both rationales are present here. 
“A plaintiff’s repeated failure to cure deficiencies in previous amendments is itself 
a basis for denying a motion for leave to amend.” Ponder Rsch. Grp., LLP v. Aquatic 
Navigation, Inc., No. 4:09-CV-322-Y, 2010 WL 1817036, at *7 (N.D. Tex. May 4, 2010) 
(citing United States ex rel. Adrian v. Regents of Univ. of Cal., 363 F.3d 398, 403 (5th Cir. 
2004)). In addition to this reply brief, Defendants detailed the flaws in Plaintiffs’ case in 
four other briefs: their original motion to dismiss, their reply in support of the original 
motion to dismiss, their opposition to Plaintiffs’ motion to stay, and their motion to 
dismiss the Amended Complaint. See ECF Nos. 18, 19, 23, 29. Also, the Court informed 
Plaintiffs of its views on those issues during the May 17, 2022 hearing. Despite these 
Case 6:22-cv-00093-ADA-DTG   Document 31   Filed 09/16/22   Page 11 of 13

 
10 
 
notifications, Plaintiffs failed to “cure the[ir] pleading defects.” Goldstein v. MCI 
WorldCom, 340 F.3d 238, 254–55 (5th Cir. 2003). Because they “have had ample 
opportunity to plead their case,” they should “not be given leave to file a second 
amended complaint.” Ponder Rsch. Grp., 2010 WL 1817036 at *7; see, e.g., Soto v. City of 
Haltom City, 106 F. App’x 903, 905 (5th Cir. 2004) (affirming denial of “leave to file a 
second amended complaint” because plaintiff “was permitted to file an amended 
complaint, but failed to remedy her pleading deficiencies”). 
Additionally, further amendments would be futile. Futility exists when “the 
amended complaint would fail to state a claim upon which relief could be granted,” as 
analyzed under the Rule 12(b)(6) standard. Gonzales, 207 F. Supp. 2d at 573 (quoting J.R. 
Stripling v. Jordan Production Co., 234 F.3d 863, 872–73 (5th Cir. 2000)). Plaintiffs have 
never “suggest[ed] . . . any additional facts not initially pled that could, if necessary, 
cure the pleading defects raised by” Defendants and the Court. Goldstein, 340 F.3d at 
255; see United States ex rel. Adrian, 363 F.3d at 404. That failure renders further 
amendment futile. Plaintiffs had two full and fair opportunities to plead a justiciable 
case; no basis exists to grant them a third. 
CONCLUSION 
For the foregoing reasons and those contained in Defendants’ motion to dismiss the 
Amended Complaint, the Court should dismiss this case for lack of subject-matter 
jurisdiction and failure to state a claim upon which relief can be granted. 
 
September 16, 2022 
 
Of Counsel: 
 
SAMUEL R. BAGENSTOS 
General Counsel 
U.S. Department of Health and Human 
Services 
Respectfully submitted, 
 
BRIAN M. BOYNTON 
Principal Deputy Assistant Attorney 
General 
 
ARUN G. RAO 
Deputy Assistant Attorney General 
Case 6:22-cv-00093-ADA-DTG   Document 31   Filed 09/16/22   Page 12 of 13

 
11 
 
MARK RAZA 
Chief Counsel 
 
WENDY VICENTE 
Deputy Chief Counsel, Litigation 
 
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 
GUSTAV W. EYLER 
Director 
 
HILARY K. PERKINS 
Assistant Director 
 
/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 31   Filed 09/16/22   Page 13 of 13

File and source

File

gov.uscourts.txwd.1159970.31.0.pdf

Size

154,197 bytes

SHA-256

5f03eb915fa59145a698dbd0cdf2ebf059a6f2d9abf96044f14221a564a07d1c

Our copy

gov.uscourts.txwd.1159970.31.0.pdf

Original

archive.org