The opinion
United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued May 4, 2026 Decided July 31, 2026
No. 25-5200
ARTHUR SOOKRA AND APRIL BURCH-SOOKRA, ON BEHALF OF
THEIR DECEASED MINOR CHILD TAYLOR ROSE SOOKRA,
APPELLANTS
v.
PFIZER INC., ET AL.,
APPELLEES
Appeal from the United States District Court
for the District of Columbia
(No. 1:24-cv-01249)
E. Scott Lloyd argued the cause and filed the briefs for
appellants.
Caroline W. Tan, Attorney, U.S. Department of Justice,
argued the cause for federal appellees. With her on the brief
were Brett A. Shumate, Assistant Attorney General, and Brad
Hinshelwood, Attorney.
David J. Weiner argued the cause for appellee Pfizer, Inc.
With him on the brief were William Hoffman and Sharon D.
Mayo.
2
Jodi V. Terranova and Teresa Pike Tomlinson were on the
response brief for appellees Mitchell Weiler, M.D. and South
Island Pediatrics P.C., joining in the brief of appellee Pfizer,
Inc.
Before: MILLETT, KATSAS, and WALKER, Circuit Judges.
Opinion for the Court filed by Circuit Judge MILLETT.
MILLETT, Circuit Judge: Fourteen-year-old Taylor Rose
Sookra fell ill and passed away in December 2021, four months
after receiving Pfizer, Inc.’s COVID-19 vaccine. Taylor’s
parents, Arthur Sookra and April Burch-Sookra (collectively,
“Sookras”) filed a lawsuit against certain federal-government
officials and Pfizer, alleging that they engaged in willful
misconduct in violation of the Public Readiness and
Emergency Preparedness Act, 42 U.S.C. § 247d-6d. The
Sookras also brought state-law tort claims against those
defendants, as well as the physician who vaccinated and treated
Taylor, and the pediatric practice where he worked.
The district court dismissed the federal-law claims on the
grounds of sovereign immunity or lack of exhaustion of
administrative remedies, and it declined to exercise
supplemental jurisdiction over the remaining state-law claims.
The Sookras appeal, challenging the dismissal of their claims
against Pfizer and the government on the ground, among
others, that the law required that the decision whether to
dismiss the complaint be made by a three-judge court.
Because the Sookras’ federal-law claims could not be
Circuit Judge Walker was a member of the panel at the time
the case was argued but did not participate in the opinion.
3
dismissed by a single-judge court, we vacate the district court’s
judgment and remand with directions for the district court to
initiate the procedures to convene a three-judge court under 42
U.S.C. § 247d-6d(e)(5). We do not reach the Sookras’
remaining challenges.
I
A
In 2005, Congress enacted the Public Readiness and
Emergency Preparedness Act (“PREP Act”) to encourage the
rapid deployment of medical countermeasures during public
health emergencies. See 42 U.S.C. §§ 247d-6d, 247d-6e;
Cannon v. Watermark Ret. Cmtys., Inc., 45 F.4th 137, 139
(D.C. Cir. 2022). The PREP Act authorizes the Secretary of
Health and Human Services to issue a declaration identifying a
public health emergency and recommending the development
of one or more medical “countermeasures.” 42 U.S.C. § 247d-
6d(b)(1). When the Secretary issues such a declaration, the Act
immunizes certain “covered person[s]” from “suit and liability
under Federal and State law with respect to all claims for loss
caused by, arising out of, relating to, or resulting from the
administration to or the use by an individual of a covered
countermeasure[.]” Id. § 247d-6d(a)(1).
Recognizing that PREP Act immunity may cut off relief
that is otherwise available to individuals who are harmed by a
covered countermeasure, Congress provided two avenues of
redress.
First, the PREP Act provides a federal cause of action
against covered persons “for death or serious physical injury”
that is proximately caused by “willful misconduct.” 42 U.S.C.
§ 247d-6d(d)(1). A plaintiff bringing a willful-misconduct
4
claim, though, must follow a “carefully limited procedural
path[.]” Cannon, 45 F.4th at 139. Among other requirements,
“such actions * * * must be filed in the [United States District
Court for the District of Columbia] and are subject to special
pleading, discovery, and damages limitations.” Id.; see 42
U.S.C. § 247d-6d(e)(1)–(9). In addition, the PREP Act
provides that “[a]ny” willful-misconduct action “shall be
assigned initially to a panel of three judges[,]” which “shall
have jurisdiction over such action for purposes of considering
motions to dismiss, motions for summary judgment, and
matters related thereto.” 42 U.S.C. § 247d-6d(e)(5).
Second, Congress established the Covered
Countermeasure Process Fund, from which harmed individuals
or their representatives may apply for compensation. 42 U.S.C.
§ 247d-6e(a). If the Secretary determines that an individual
qualifies for compensation, that individual either may accept
the offered compensation and forgo a willful-misconduct
claim, or may reject the offer and sue. Id. § 247d-6e(d)(5). The
PREP Act further provides that, with certain exceptions, a
plaintiff may not bring a willful-misconduct action “unless
such individual has exhausted” the available administrative
remedies by applying for compensation from the Fund. Id.
§ 247d-6e(d)(1).
B
In March 2020, the Secretary of Health and Human
Services issued a PREP Act declaration to provide “liability
immunity for activities related to medical countermeasures
against COVID-19.” Declaration Under the Public Readiness
and Emergency Preparedness Act for Medical
Countermeasures Against COVID-19, 85 Fed. Reg. 15,198,
15,198 (March 17, 2020). The covered countermeasures
include “any vaccine” used to treat or prevent COVID-19. Id.
5
at 15,201–15,202. As all parties in this case agree, Pfizer’s
COVID-19 vaccine is a “covered countermeasure” within the
meaning of the March 2020 declaration.1
In July and August 2021, Taylor received two doses of
Pfizer’s COVID-19 vaccine from Dr. Mitchell Weiler at South
Island Pediatrics in Cedarhurst, New York. J.A. 70. Four
months later, in December 2021, Taylor began experiencing
flu-like symptoms and sought treatment from Dr. Weiler. J.A.
70. Taylor seemed to be recovering well, but she then took a
turn for the worse. On December 25th, Taylor was found
unresponsive by her mother and taken to the hospital, where
she was pronounced dead. J.A. 70. The Medical Examiner
reported her cause of death as acute cardiac failure due to
myocarditis (inflammation of the heart muscle), adding that
“COVID-19 infection with pneumonitis” (inflammation of
lung tissue) was a “significant condition.” J.A. 70 (formatting
modified).
C
Taylor’s parents, Mr. Sookra and Ms. Burch-Sookra, filed
suit in the United States District Court for the Eastern District
of New York, asserting both state- and federal-law claims
against Pfizer, the Secretary of Health and Human Services,
and the Berkeley Carroll School (which had required the
vaccination of its students, including Taylor). See Compl. at
1
See Second Am. Compl. at 3, Sookra, No. 24-cv-1249, ECF
No. 47 (“Pfizer’s vaccine was * * * a ‘covered countermeasure’
under the meaning of the [PREP] Act[.]”); Gov’t Resp. Br. 8 (“[T]he
government has not disputed[] that the Secretary * * * listed Pfizer’s
COVID-19 vaccine as a covered countermeasure.”); Pfizer Resp. Br.
6 (“[T]he COVID-19 vaccine is a covered countermeasure under the
PREP Act.”); Weiler & South Island Pediatrics Resp. Br. 1 (joining
Pfizer’s brief).
6
5–6, Sookra v. Berkeley Carroll School, No. 23-cv-9491
(E.D.N.Y. Dec. 26, 2023), ECF No. 1. As the suit proceeded,
the Sookras sought to add a PREP Act willful-misconduct
claim. Because such a claim may be brought only in the United
States District Court for the District of Columbia, 42 U.S.C.
§ 247d-6d(e)(1), the Sookras moved to transfer their case. The
district court granted the transfer request.
The case, along with the Civil Cover Sheet from the
District Court for the Eastern District of New York, was
docketed in the District Court for the District of Columbia.
There was no option on that form for the Sookras to request a
three-judge court, and the Sookras did not separately request
one. See generally Civil Cover Sheet, Sookra v. Pfizer, Inc.,
No. 24-cv-1249 (D.D.C. March 26, 2025), ECF No. 2.
The Sookras then twice amended their complaint to assert
a PREP Act willful-misconduct claim against Pfizer, the
Secretary of Health and Human Services, and the
Commissioner of the Food and Drug Administration. See Am.
Compl. at 10–12, ECF No. 17; Second Am. Compl. at 11–13,
ECF No. 47. The second amended complaint also included
various state-law tort claims against those same defendants, as
well as Dr. Weiler and South Island Pediatrics. See Second
Am. Compl. at 11–16. The Sookras dropped the Berkeley
Carroll School as a defendant. See Am. Compl. at 1.
The Defendants moved to dismiss the Sookras’ complaint.
Those motions were referred to a magistrate judge who
recommended dismissing the claims against (1) the federal
government on sovereign-immunity grounds, and (2) Pfizer
due to the Sookras’ failure to exhaust administrative remedies.
Sookra v. Pfizer, Inc., No. 24-cv-1249, 2025 WL 341732, at
*3, *6 (D.D.C. Jan. 30, 2025), report and recommendation
adopted, No. 24-cv-1249, 2025 WL 1545354 (D.D.C. Mar. 26,
7
2025). The magistrate judge then recommended dismissal of
the state-law claims against Pfizer on the basis of its PREP Act
immunity. Id. at *6–7. Finally, the magistrate judge
recommended that the district court decline to exercise
supplemental jurisdiction over the remaining state-law claims
against Dr. Weiler and South Island Pediatrics. Id. at *7. The
magistrate judge observed in passing that the Sookras had
“neglected other PREP Act requirements[,]” including a
“fail[ure] to apply for a three-judge court, as required by both
statute and this Court’s Local Civil [Rule 9.1].” Id. at *6 n.4.
The Sookras filed objections to the magistrate judge’s
Report & Recommendation and also applied for a three-judge
court. See generally Pltfs.’ Objs. to R&R, ECF No. 65; Appl.
for Three-Judge Ct., ECF No. 66. The district court adopted
the magistrate judge’s recommendations in full and granted the
motions to dismiss. Sookra v. Pfizer, Inc., No. 24-cv-1249,
2025 WL 1545354, at *1–2 (D.D.C. Mar. 26, 2025). The court
then dismissed the motion for a three-judge court as moot. Id.
at *2.
The Sookras timely appealed.2
II
This court has jurisdiction under 28 U.S.C. § 1291. We
review de novo a dismissal for lack of jurisdiction, Pueschel v.
Chao, 955 F.3d 163, 165 (D.C. Cir. 2020), and independently
determine the proper interpretation of federal laws, Campaign
2
While the appeal was pending, Kyle Diamantas was named
Acting Commissioner of the Food and Drug Administration. Acting
Commissioner Diamantas has been substituted as Appellee. See
FED. R. APP. P. 43(c)(2).
8
for Accountability v. Department of Justice, 155 F.4th 724, 733
(D.C. Cir. 2025).
III
The Sookras argue that the district court erred by
dismissing their claims against the federal government on
sovereign immunity grounds, and dismissing their claims
against Pfizer for failure to exhaust administrative remedies.
The Sookras further contend that the district court improperly
dismissed the complaint instead of referring the motions to
dismiss to a three-judge court.
The Sookras are correct that the district court improperly
dismissed the complaint. The plain text of Section 247d-
6d(e)(5) of the PREP Act requires a three-judge court to rule
on motions to dismiss willful-misconduct claims, regardless of
whether the requested dismissal is for lack of jurisdiction or for
failure to state a claim. The only exception to the three-judge
requirement is when the claim is so wholly insubstantial that it
fails to raise a substantial federal question at all, which is not
this case.
We accordingly vacate the district court’s dismissal order
and remand the case to the district court with instructions to
request that the Chief Judge of the Circuit convene a three-
judge court to adjudicate the motions to dismiss and related
matters within its jurisdiction. Because of that threshold error,
we do not address the parties’ remaining arguments.
A
At the outset, both the magistrate judge and district court
faulted the Sookras for not timely requesting a three-judge
court. See Sookra, 2025 WL 341732, at *6 n.4 (magistrate
9
judge recommendation that the Sookras failed to apply for a
three-judge court as required by 42 U.S.C. § 247d-6d(e)(5) and
D.D.C. Local Civil Rule 9.1); Sookra, 2025 WL 1545354, at
*1–2.
At least on its face, Section 247d-6d(e)(5) of the PREP Act
does not require a plaintiff asserting willful misconduct to
apply for a three-judge court, rather than for the court either to
sua sponte provide it or to set a deadline for the application. A
local district court rule, though, provides that any application
for a three-judge court “shall be filed with the complaint[.]”
D.D.C. Local Civil Rule 9.1. Yet the Sookras filed their
request only after the issuance of the Report and
Recommendation. See Appl. for Three-Judge Ct. at 1.
Because no party presented the question to the district court
or to us, we need not—and do not—decide whether either the
PREP Act or Local Civil Rule 9.1 imposes a timeliness
requirement for requesting a three-judge court, or whether a
request must be made at all.
None of the Defendants asked the district court to dismiss
the complaint or deny the Sookras’ application for a three-
judge court on timeliness grounds. Quite the opposite. The
federal government defendants said that they “do not object to
the Plaintiffs’ Application for Three-Judge Court[.]” Gov’t
Resp. to Obj. at 8 n.2, ECF No. 67 (emphasis added).
Similarly, Pfizer acknowledged that the “Plaintiffs [have] filed
a motion to convene a three-judge panel” without arguing that
the motion was barred as untimely. Pfizer Resp. to Obj. at 7
n.3, ECF No. 69. Dr. Weiler and South Island Pediatrics did
not mention the application at all. See generally Weiler &
South Island Pediatrics Resp. to Obj., ECF No. 70.
10
Nor have the Defendants argued to this court that the
Sookras’ application was untimely. They seek affirmance
solely on the grounds of sovereign immunity (as to the federal
defendants) and lack of exhaustion (as to all defendants). See
Gov’t Resp. Br. 16–29; Pfizer Resp. Br. 12–14; Weiler and
South Island Pediatrics Resp. Br. 1.
Accordingly, we assume without deciding that the Sookras
timely requested a three-judge court. See District of Columbia
v. Air Florida, Inc., 750 F.2d 1077, 1084 (D.C. Cir. 1984)
(“[I]ssues and legal theories not asserted at the District Court
level ordinarily will not be heard on appeal.”); United States ex
rel. Totten v. Bombardier Corp., 380 F.3d 488, 497 (D.C. Cir.
2004) (“[A]rguments that parties do not make on appeal are
deemed to have been waived.”).
B
Turning to the heart of this appeal, we hold that the single
district court judge could not dismiss the Sookras’ complaint.
Section 247d-6d(e)(5) of the PREP Act explicitly requires a
three-judge court to rule on all motions to dismiss, unless the
plaintiffs’ claims are so wholly insubstantial as to not even
colorably arise under the PREP Act. See Shapiro v. McManus,
577 U.S. 39, 44–46 (2015). Because the Sookras’ claims are
not insubstantial, the single-judge district court lacked
authority to dismiss the complaint.
1
The PREP Act generally requires a three-judge court to
rule on motions to dismiss, whether on jurisdictional grounds
or for failure to state a claim, in any willful-misconduct case
brought under the Act.
11
First, the statutory language says so. It expressly and
unambiguously requires motions to dismiss in willful-
misconduct actions to be decided by a three-judge court.
The opening proviso of Section 247d-6d(e)(5) states that
“[a]ny” willful-misconduct action brought under the PREP Act
“shall be assigned initially to a panel of three judges.” 42
U.S.C. § 247d-6d(e)(5). We need not decide in this case how
early that “initial[]” assignment to a three-judge court must be
because the PREP Act makes clear that a three-judge court—
and only a three-judge court—must preside at least by the time
a motion to dismiss, or a “matter[] related” to such a motion, is
to be “consider[ed.]” Id. The statute says in no uncertain terms
that “a panel of three judges * * * shall have jurisdiction over
such [willful-misconduct] action for purposes of considering
motions to dismiss, motions for summary judgment, and
matters related thereto.” Id. (emphasis added).
That directive is mandatory—the case “shall be assigned”
to a panel of three judges, and that panel “shall have
jurisdiction over the action” for purposes of deciding motions
to dismiss and related matters. 42 U.S.C. § 247d-6d(e)(5)
(emphases added). Congress’s use of the word “shall”
“normally creates an obligation impervious to judicial
discretion.” Shapiro, 577 U.S. at 43 (quoting Lexecon Inc. v.
Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26, 35
(1998)); see National Ass’n. of Home Builders v. Defenders of
Wildlife, 551 U.S. 644, 661–662 (2007) (similar);
Kingdomware Techs., Inc. v. United States, 579 U.S. 162, 171
(2016) (“[T]he word ‘shall’ usually connotes a requirement.”).
That is why the Supreme Court has held that a statute that
provides generally applicable procedures for many three-
judge-court review schemes, 28 U.S.C. § 2284, sets out a non-
discretionary “prescription” when it says that a “‘district court
12
of three judges shall be convened[.]’” Shapiro, 577 U.S. at 43
(quoting 28 U.S.C. § 2284(a)).
Section 247d-6d(e)(5)’s language is also categorical. The
assignment of a three-judge court applies to “[a]ny action” for
willful misconduct under the PREP Act. 42 U.S.C. § 247d-
6d(e)(5). And it applies to “motions to dismiss” without any
qualification. Id. The statute does not say or suggest that its
assignment rule applies only to some types of motions to
dismiss, or only in some circumstances. Given the PREP Act’s
unflinching language, at the very least, the assignment to a
three-judge court must occur in time for the required multi-
member panel to rule on any motions to dismiss the complaint,
or “matters related thereto.” Id.
Congress’s mandatory language no doubt was purposeful.
The surrounding subsections of Section 247d-6d repeatedly
vary between “may” and “shall” in their directions. One
subsection, for instance, states that the Secretary “may” issue a
declaration triggering PREP Act immunity. 42 U.S.C. § 247d-
6d(b)(1). This provision affords the Secretary some measure
of discretion over whether to take that action. See also, e.g., id.
§ 247d-6d(b)(3)(A). But elsewhere, Congress employs
language of command. For example, in issuing a declaration,
the Secretary “shall” identify, among other things, the time
period(s) during which the declaration is in effect for each
countermeasure. Id. § 247d-6d(b)(2). Together, those
provisions illustrate that Congress granted discretion when it
meant to in the PREP Act, and denied it when it intended no
such choice. See Kingdomware Techs., 579 U.S. at 172
(“When a statute distinguishes between ‘may’ and ‘shall,’ it is
generally clear that ‘shall’ imposes a mandatory duty.”).
Second, the PREP Act expressly overrides some of the
procedures laid out in the generally applicable three-judge-
13
court statute, 28 U.S.C. § 2284, under which a single judge
“may conduct all proceedings except the trial,” id. § 2284(b)(3)
(emphasis added). See 42 U.S.C. § 247d-6d(e)(5) (stating that
“paragraph (3) of subsection (b) of Section 2284 of title 28 shall
not apply”). In other words, Congress went out of its way to
invert the usual order of operations for three-judge courts.
Under Section 2284(b)(3), a single judge handles pre-trial
motions, handing the reins to a three-judge court only for trial.
Under the PREP Act, in contrast, a three-judge court handles
pretrial matters like motions to dismiss and for summary
judgment, and then “refer[s] the action to the chief judge for
assignment for further proceedings, including any trial.” 42
U.S.C. § 247d-6d(e)(5). That inversion of the usual three-
judge court procedure indicates that Congress acted with
deliberation in designing the PREP Act’s three-judge-review
scheme.
Third, past practice in this circuit accords with this natural
understanding of Section 247d-6d(e)(5). In Estate of George
Watts, Jr. v. Hegseth, a single judge dismissed a PREP Act
action on the ground that the federal-government defendant
was immune to suit. See Order at 2, No. 23-cv-1544 (D.D.C.
Feb. 18, 2026), ECF No. 17. The plaintiff sought relief from
that judgment under Federal Rule of Civil Procedure 60(b),
arguing that Section 247d-6d(e)(5) required the case to be
assigned to a three-judge court from the outset. Mot. for Relief
from J. at 2–3, ECF No. 18. Agreeing with the plaintiff, the
district court vacated its own order and requested that the Chief
Judge of the Circuit convene a three-judge court. Order at 2,
ECF No. 25. The newly convened panel then ruled on the
motion to dismiss. See generally Order, ECF No. 32.3
3
In the only other PREP Act case of which we are aware, the
single-judge district court granted a motion to dismiss. But the
14
Fourth, as far as we can tell, the PREP Act’s trial court
scheme is unique. The parties have not cited any statute—and
we have found none—where Congress provided that a case
must go “initially” to a three-judge court, including for motions
to dismiss. Of the other three-judge-review statutes, some
simply adopt the procedures provided under Section 2284,
whereas others require a particular party to request a three-
judge court. The distinctiveness of the PREP Act’s review
scheme indicates that Congress deliberately designed Section
247d-6d(e)(5) differently, and so Congress meant exactly what
it said in mandating that PREP Act willful-misconduct cases
must go “initially” to a panel of three judges for a motion to
dismiss.4
plaintiff in that case did not file an opposition to dismissal and the
parties did not address the necessity of a three-judge court. See
generally Mem. Op., Zelig v. City Medical of New Jersey PC, No.
21-cv-961 (D.D.C. July 9, 2021), ECF No. 12.
4
Some three-judge-court statutes state that the action shall be
heard “in accordance with section 2284 of title 28[,]” or similar
language. E.g., Gramm-Rudman-Hollings Act, 2 U.S.C. § 922; see
also, e.g., Act of June 25, 1948, 3 U.S.C. § 5(d)(1)(B); Prison
Litigation Reform Act, 18 U.S.C. § 3626(a)(3)(B); Cable Television
Consumer Protection and Competition Act of 1992, 47 U.S.C.
§ 555(c)(1); Voting Rights Act of 1965, 52 U.S.C. §§ 10303, 10304,
10306; Bipartisan Campaign Reform Act of 2002, Pub. L. No. 107-
155, § 403, 116 Stat. 81, 113; Children’s Internet Protection Act,
Pub. L. No. 106-554, § 1741, 114 Stat. 2763, 2763A–351 to 2763A–
352 (2000); Departments of Commerce, Justice, and State, the
Judiciary, and Related Agencies Appropriations Act, 1998, Pub. L.
No. 105-119, § 209(e)(1), 111 Stat. 2440, 2482 (1997); Act of Dec.
10, 1973, Pub. L. No. 93-178, § 2(b), 87 Stat. 697, 697; Act of July
22, 1958, Pub. L. No. 85-547, § 1, 72 Stat. 403, 403.
15
Finally, the requirement of promptly assigning the case to
a three-judge court to address a preliminary matter such as a
motion to dismiss makes sense in light of statutory and
historical context. In the PREP Act, Congress carefully
balanced the urgent incentivization, development, and
deployment of medical countermeasures during public health
emergencies with the need to fairly compensate individuals
who suffer harm associated with those countermeasures. See
Cannon, 45 F.4th at 139; cf. Hearing on Funding Needs for
Pandemic Influenza Preparedness Before the Subcomm. on
Labor, Health and Human Servs., and Educ. of the H. Comm.
on Appropriations, 109th Cong. 10, 78 (2005) (statement of
Michael O. Leavitt, Sec’y of Health & Human Servs.) (“The
draft legislation we have submitted to Congress” “strikes an
appropriate balance of removing the liability risks that dissuade
companies from producing pandemic countermeasures, while
still retaining appropriate access to court remedies.”).
Congress considered bringing the collective judgment of a
three-judge court to bear on willful-misconduct cases to be the
Other statutes require a request for a three-judge court from a
particular party. See, e.g., Prison Litigation Reform Act, 18 U.S.C.
§ 3626(a)(3)(C) (request by party seeking prisoner release order);
Presidential Election Campaign Fund Act of 1971, 26 U.S.C.
§§ 9010, 9011 (by Federal Election Commission); Customs Courts
Act of 1970, 28 U.S.C. § 255(a) (by any party to a civil action or
upon the initiative of the chief judge of the Court of International
Trade); Civil Rights Act of 1964, 42 U.S.C. §§ 2000a-5(b), 2000e-
6(b) (by Attorney General); Regional Rail Reorganization Act of
1973, 45 U.S.C. § 719(b)(1) (by U.S. Railway Association); Voting
Rights Act of 1965, 52 U.S.C. § 10101(g) (by Attorney General).
Finally, a statute pertaining to the United States Court of Federal
Claims states that, upon the referral of certain bills from Congress,
the chief judge shall designate a three-judge court according to
procedures under 28 U.S.C. § 2509(a).
16
most efficient and effective means of accomplishing those ends
while underscoring the importance of cases arising from
necessarily rapid responses to public health crises. Cf. 17A
WRIGHT & MILLER’S FEDERAL PRACTICE & PROCEDURE
§ 4235 (3d ed. April 2026) (noting that the Senate Judiciary
Committee deemed three-judge courts necessary for
reapportionment cases because “these issues are of such
importance that they ought to be heard by a three-judge court”);
Swift & Co. v. Wickham, 382 U.S. 111, 127 (1965) (Congress’s
use of a three-judge court “show[s] quite clearly what sort of
cases were of concern to [it.]”); see David P. Currie, The Three-
Judge District Court in Constitutional Litigation, 32 U. CHI. L.
REV. 1, 1–2 (1964) (similar).
2
a
The Defendants argue that Congress surely did not intend
that every claim, no matter how frivolous, would warrant the
devotion of such significant judicial resources. They invoke a
line of cases in which the Supreme Court has held that a “three-
judge court is not required where the district court itself lacks
jurisdiction of the complaint or the complaint is not justiciable
in the federal courts.” Gov’t Resp. Br. 14 (quoting Gonzalez v.
Automatic Emps. Credit Union, 419 U.S. 90, 100 (1974)); see
Pfizer Resp. Br. 14–18.
Perhaps a single-judge district court can dismiss a case or
claim if it is so “wholly insubstantial and frivolous” that it does
not “raise a substantial federal question” under the PREP Act
sufficient for federal court jurisdiction even to attach. Shapiro,
577 U.S. at 45. But that is a very low threshold. The
“exception for insubstantial claims is narrow.” Independence
Inst. v. FEC, 816 F.3d 113, 116 (D.C. Cir. 2016). It applies
17
“only when the case is ‘essentially fictitious, wholly
insubstantial, obviously frivolous, and obviously without
merit.’” Id. (quoting Shapiro, 577 U.S. at 45–46); see also
Shapiro, 577 U.S. at 46 (“[T]he adverbs [are] no mere
throwaways; the limiting words ‘wholly’ and ‘obviously’ have
cogent legal significance.”) (formatting modified) (quoting
Goosby v. Osser, 409 U.S. 512, 518 (1973)).
In short, under the PREP Act, a single-judge district court
may dismiss, at most, if the case is so fribbling that it does not
even amount to “an[] action under [Section 247d-6d(d) of the
PREP Act.]” 42 U.S.C. § 247d-6d(e)(5). Absent such
frivolity, the single-judge district court must initiate the
procedures for a three-judge court under Section 247d-6d(e)(5)
to address any motion to dismiss. See, e.g., Independence Inst.,
816 F.3d at 117 (remanding for convening of three-judge
court).
But that point gains the Defendants no ground. The
Sookras’ assertion of federal-question jurisdiction over their
PREP Act claims easily clears that “low bar.” Shapiro, 577
U.S. at 46. Indeed, the Defendants do not even suggest that the
Sookras’ claims fail to arise under the PREP Act, 42 U.S.C.
§ 247d-6d(d)(1). Nor is there any colorable argument that the
Sookras’ claims are entirely frivolous or wholly insubstantial.
In addition, all agree that Pfizer’s COVID-19 vaccine was a
“covered countermeasure” that was administered to Taylor, id.
§ 247d-6d(i)(1), and that each Defendant is a “covered person”
within the meaning of the statute, id. § 247d-6d(i)(2).
Given all of that, the Sookras’ case required the
appointment of a three-judge court to decide the Defendants’
motions to dismiss and any related matters. Whether the
Sookras’ claims are foreclosed by sovereign immunity, barred
for lack of exhaustion, warrant pendent jurisdiction, or
18
otherwise warrant dismissal is for that three-judge court to
decide.
b
The Defendants’ remaining arguments do not change
anything.
i
The Defendants point to the holding in Gonzalez v.
Automatic Employees Credit Union, 419 U.S. 90 (1974), that a
single-judge district court may dismiss a complaint for lack of
jurisdiction (there, lack of standing), id. at 100. They argue
that this holding extends to dismissals on the grounds of
sovereign immunity or lack of exhaustion of administrative
remedies. See Gov’t Resp. Br. 20–22; Pfizer Resp. Br. 11–12,
14–16.
There are four significant problems with that argument.
First, Gonzalez and all the other cases on which the
Defendants rely involve Section 2284 or statutes that borrow
its procedures. As relevant here, Section 2284 provides:
Upon the filing of a request for three judges, the judge
to whom the request is presented shall, unless he
determines that three judges are not required,
immediately notify the chief judge of the circuit, who
shall designate two other judges * * * [to] serve as
members of the court to hear and determine the action
or proceeding.
28 U.S.C. § 2284(b)(1) (emphasis added); see Shapiro, 577
U.S. at 44 (involving Section 2284); Gonzalez, 419 U.S. at 92,
19
100 (now-repealed 28 U.S.C. § 2281, borrowing Section
2284’s procedures); McLucas v. DeChamplain, 421 U.S. 21,
28 (1975) (now-repealed 28 U.S.C. § 2282, borrowing Section
2284’s procedures); Community Oncology Alliance, Inc. v.
Office of Mgmt. & Budget, 987 F.3d 1137, 1142 (D.C. Cir.
2021) (2 U.S.C. § 922, borrowing Section 2284’s procedures);
Independence Inst., 816 F.3d at 115–116 (52 U.S.C. § 30110
note, borrowing Section 2284’s procedures); Wertheimer v.
FEC, 268 F.3d 1070, 1072 (D.C. Cir. 2001) (26 U.S.C. § 9011,
borrowing Section 2284’s procedures); Eastern States
Petroleum Corp. v. Rogers, 265 F.2d 593, 595–597 (D.C. Cir.
1959) (older version of Section 2284).
The language in Section 2284 expressly contemplates a
role for the single judge, including preliminary matters like
singlehandedly resolving motions to dismiss, see 28 U.S.C.
§ 2284(b)(3). In addition, the statute expressly allows the
single-judge court to retain the case if it “determines that three
judges are not required[.]” Id. § 2284(b)(1); cf. Shapiro, 577
U.S. at 43–44.
That language is pointedly absent from the PREP Act. The
district court is given no license to decide if a three-judge court
is warranted, and the statute itself expressly and
unambiguously assigns motions to dismiss and for summary
judgment to three-judge courts. The PREP Act does not even
contemplate a potential role for a single-judge district court
until after those motions and related matters have been
resolved. See 42 U.S.C. § 247d-6d(e)(5) (requiring the three-
judge court to “refer the action to the chief judge for further
proceedings, including any trial[,]” after the panel “has denied
[the relevant] motions, or if the time for filing such motions has
expired”). Given the material differences in how the PREP Act
is written, the Defendants’ reliance on cases involving a
differently worded statute is beside the point.
20
Second, all but two of the Defendants’ cases predate the
Supreme Court’s decision in Shapiro v. McManus, 577 U.S. 39
(2015), which significantly narrowed the role of a single-judge
district court even under Section 2284. Shapiro held that a
single judge’s statutory authority to “determine[] that three
judges are not required” is confined to the narrow question of
determining “whether the ‘request for three judges’ is made in
a case covered by § 2284(a)—no more, no less.” 577 U.S. at
43–44; see Independence Inst., 816 F.3d at 116 (Kavanaugh,
J.) (“[A]s the Shapiro Court stressed, the exception for
insubstantial claims is narrow.”).
The remaining two cases read and apply Shapiro in the
same way we do. In one, this court held that the single-judge
district court had properly retained a case because the three-
judge provision at issue there “d[id] not cover the claims in
th[at] case.” Community Oncology All., 987 F.3d at 1142
(“[A]lthough [2 U.S.C. § 922(a)(5)] requires the merits of ‘any
action brought under’ section 922(a)(2) to be ‘heard and
determined by a three-judge court,’ that provision did not bar
the district court from determining whether this action was
properly ‘brought under’ section 922(a)(2) in the first place.”)
(formatting modified) (internal citations omitted) (citing
Shapiro, 577 U.S. at 43–45). In the other, the court held as we
do that the plaintiff’s case cleared the “low bar” for raising a
substantial federal question, and thus “entitled [the plaintiff] to
make its case to a three-judge district court.” Independence
Institute, 816 F.3d at 116–117.
Third, the Defendants retort that Gonzalez’s holding was
rooted in the background practice of having single-judge
district courts decide jurisdictional questions in the first
instance. That argument has two fundamental flaws.
21
To start, absent a constitutional limitation—which is not
raised here—Congress is free to displace such background
understandings. See, e.g., Mississippi ex rel. Hood v. AU
Optronics Corp., 571 U.S. 161, 175 (2014). And that is what
the PREP Act does by mandating that “motions to dismiss” go
to a three-judge court. 42 U.S.C. § 247d-6d(e)(5); see Babb v.
Wilkie, 140 S. Ct. 1168, 1177 (2020) (“[W]here, as here, the
words of a statute are unambiguous, the judicial inquiry is
complete.”) (formatting modified).
ii
The Defendants separately argue that the district court
properly dismissed this complaint for lack of jurisdiction due
to the Sookras’ failure to exhaust the PREP Act remedy by
seeking compensation through the Covered Countermeasure
Process Fund.
That argument assumes, however, that the exhaustion
requirement is jurisdictional. Yet exhaustion requirements are
commonly not jurisdictional. See Santos-Zacaria v. Garland,
143 S. Ct. 1103, 1111–1114 (2023); Arbaugh v. Y & H Corp.,
546 U.S. 500, 515 (2006). The Defendants have not presented
any meaningful argument to this court that the PREP Act’s
exhaustion requirement is jurisdictional. See Gov’t Resp. Br.
15, 26 (referring only to the exhaustion requirement as
“mandatory”); Pfizer Resp. Br. 13 (one-sentence argument that
the exhaustion requirement is jurisdictional); Oral Arg. Tr.
52:18–48 (no argument from Pfizer’s counsel that the
exhaustion requirement is jurisdictional, even when questioned
directly on the issue). That omission leaves a fatal hole in
Defendants’ argument. See also Government of Manitoba v.
Bernhardt, 923 F.3d 173, 179 (D.C. Cir. 2019) (“A party
forfeits an argument by mentioning it only in the most skeletal
way, leaving the court to do counsel’s work, create the ossature
22
for the argument, and put flesh on its bones.”) (quotation marks
omitted).
iii
Pfizer, Dr. Weiler, and South Island Pediatrics ask this
court to affirm the district court’s judgment of dismissal on the
alternative ground that the Sookras failed to file certified
medical records or physician affidavits with their complaint, as
required by Section 247d-6d(e)(4). Pfizer Resp. Br. 16; Weiler
& South Island Pediatrics Resp. Br. 1.
To be clear, the PREP Act requires only “substantial[]
compl[iance]” with that obligation. 42 U.S.C. § 247d-
6d(e)(4)(A) (emphasis added). More to the point, whether the
Sookras substantially complied with that provision is an
argument in support of a motion to dismiss that must be
decided by a three-judge court.
IV
For the foregoing reasons, we vacate the district court’s
order granting the Defendants’ motions to dismiss, reverse its
denial of the Sookras’ motion for a three-judge court, and
remand with directions for the district court to initiate the
procedures to convene a three-judge court.
So ordered.