United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued April 20, 2009 Decided September 29, 2009
No. 08-5117
THOMAS REMPFER, U.S. AIR FORCE, ET AL.,
APPELLANTS
v.
JOSHUA M. SHARFSTEIN, MD, ACTING COMMISSIONER, FOOD
AND DRUG ADMINISTRATION, ET AL.,
APPELLEES
Appeal from the United States District Court
for the District of Columbia
(No. 1:06-cv-02131-RMC)
John J. Michels Jr. argued the cause for appellants. With
him on the briefs was Mark S. Zaid.
Melissa N. Patterson, Attorney, U.S. Department of Justice,
argued the cause for appellees. With her on the brief were
Michael F. Hertz, Acting Assistant Attorney General, Jeffrey A.
Taylor, U.S. Attorney, and Mark B. Stern, Attorney. R. Craig
Lawrence, Assistant U.S. Attorney, entered an appearance.
Before: HENDERSON, TATEL, and GARLAND, Circuit
Judges.
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Opinion for the Court filed by Circuit Judge GARLAND.
GARLAND, Circuit Judge: Pursuant to the Department of
Defense’s Anthrax Vaccine Immunization Program, members of
the armed forces may be ordered to submit to inoculation against
anthrax disease. Eight servicemembers brought suit in district
court to challenge the Food and Drug Administration’s approval
of the anthrax vaccine and to enjoin the Defense Department
from administering it. The district court dismissed three counts
of the complaint on the merits and dismissed a fourth count
because the plaintiffs lack standing to make it. We affirm.
I
Anthrax is an acute bacterial disease caused by infection
with spores of Bacillus anthracis. It can be contracted through
three routes of exposure: by skin contact (cutaneously), by
inhalation, and by ingestion. From 1954-1959, a clinical study
led by Dr. Philip Brachman tested an anthrax vaccine produced
by the Department of Defense (DOD). See Philip S. Brachman
et al., Field Evaluation of a Human Anthrax Vaccine, 52 AM. J.
PUB. HEALTH 632 (1962) [hereinafter Brachman Study]. Dr.
Brachman studied 1249 textile workers exposed to imported
goat hair, dividing the population into a vaccine group, a
placebo group, and an observational (no treatment) group. Id.
at 634, 638.1 During the study, 26 cases of anthrax occurred: 21
1
As the FDA explained: The Brachman Study’s “selected
population was at risk because the mill workers routinely handled
anthrax-infected animal materials. Prior to vaccination, the yearly
average number of human anthrax infections among workers in these
mills was 1.2 cases per every 100 employees.” Biological Products;
Bacterial Vaccines and Toxoids; Implementation of Efficacy Review;
Anthrax Vaccine Adsorbed; Final Order, 70 Fed. Reg. 75,180, 75,186
(Dec. 19, 2005). By the mid-1980s, this industrial setting was
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contracted cutaneously and 5 by inhalation. Id. at 638. Three of
the cutaneous cases occurred in the vaccine group; the
remainder, and all inhalation cases, occurred in the placebo and
observational groups. Id. The study calculated that the vaccine
was 92.5 percent effective (lower 95 percent confidence limit =
65 percent). Id. at 644. The study noted, however, that the
small number of inhalation cases “makes the data less
significant in showing effectiveness of the vaccine” with respect
to that “form of the disease.” Id. at 643.
DOD subsequently contracted with Merck, Sharpe, &
Dohme to develop a new version of the vaccine for large-scale
production. See Food and Drug Administration (FDA),
Biological Products; Bacterial Vaccines and Toxoids;
Implementation of Efficacy Review; Anthrax Vaccine
Adsorbed; Final Order, 70 Fed. Reg. 75,180, 75,192 (Dec. 19,
2005) [hereinafter 2005 Final Order]. Later, it entered into a
similar contract with the Michigan Department of Public Health
(MDPH), the relevant division of which is now operated by the
BioPort Corporation. Id. at 75,181, 75,182, 75,192, 75,197.
MDPH/BioPort produced and continues to produce the current
generation of the vaccine, known as Anthrax Vaccine Adsorbed
(AVA). Id. at 75,192.
“vanishing, precluding any further clinical studies.” Biological
Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy
Review, 50 Fed. Reg. 51,002, 51,058 (Dec. 13, 1985). Today, “due
to the significant health risks associated with exposure to anthrax
spores, it would not be ethical to actively expose human study subjects
to B. anthracis spores in order to assess the effectiveness of an anthrax
vaccine in a controlled clinical trial. Furthermore, naturally occurring
anthrax is now so rare that a field study of vaccine effectiveness is no
longer feasible in the United States.” 70 Fed. Reg. at 75,192.
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Prior to 1972, the National Institutes of Health (NIH) was
the agency responsible for the licensing of biological products.
See 2005 Final Order, 70 Fed. Reg. at 75,181. In 1970, NIH
issued a license for AVA. As labeled, the vaccine was to be
administered in a six-shot sequence, with specified intervals
between each inoculation. Id. at 75,184.
In 1972, responsibility for licensing biological products was
transferred from NIH to the FDA. Id. at 75,181. The FDA then
issued procedures for determining that products previously
licensed by NIH “are safe, effective, and not misbranded.”
Procedures for Review of Safety, Effectiveness and Labeling, 38
Fed. Reg. 4319, 4321 (Feb. 13, 1973) (codified as amended at
21 C.F.R. § 601.25). Under those procedures, the FDA appoints
an independent advisory panel to report on covered products.
See 21 C.F.R. § 601.25(a), (e). After reviewing the panel’s
recommendations, the FDA makes its own determination, which
it publishes as a proposed order along with the panel’s report.
See id. § 601.25(f). After receiving and reviewing comments,
the FDA publishes a final order. See id. § 601.25(g).
In 1973, the FDA announced that advisory panels would
review the safety and effectiveness of several vaccines
previously licensed by NIH, including AVA. Biological
Products; Bacterial Vaccines and Toxoids with Standards of
Potency, Single or in Combination; Safety, Effectiveness and
Labeling Review; Request for Data Information, 38 Fed. Reg.
5358 (Feb. 28, 1973). In 1980, an advisory panel submitted a
report finding that the “best evidence for the efficacy of anthrax
vaccine comes from [the] placebo-controlled field trial
conducted by Brachman.” Biological Products; Bacterial
Vaccines and Toxoids; Implementation of Efficacy Review, 50
Fed. Reg. 51,002, 51,058 (Dec. 13, 1985). Although the panel
concluded that “inhalation anthrax occurred too infrequently [in
the Brachman Study] to assess the protective effect of vaccine
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against this form of the disease,” it recommended categorizing
AVA as “safe and effective under the limited circumstances for
which [it] is employed.” Id. at 51,058, 51,059. In 1985, the
FDA issued a proposed order classifying AVA as “safe and
effective and not misbranded,” id. at 51,104, but it did not issue
a final order, see 2005 Final Order, 70 Fed. Reg. at 75,182.
In 1998, DOD implemented the Anthrax Vaccine
Immunization Program (AVIP), which subjected members of the
Armed Forces at risk of anthrax exposure to mandatory
administration of AVA. See id. at 75,183. Thereafter, Congress
directed DOD to support an independent examination of AVA
by the Institute of Medicine of the National Academy of
Sciences. Id.; see H.R. Rep. No. 106-371, at 256 (1999) (Conf.
Rep.). A committee convened by the Institute conducted the
study, examined “all available data,” and concluded that, “[a]s
indicated by evidence from studies in both humans and animals,
. . . AVA, as licensed, is an effective vaccine to protect humans
against anthrax, including inhalational anthrax.” COMM. TO
ASSESS THE SAFETY AND EFFICACY OF THE ANTHRAX VACCINE,
INSTITUTE OF MEDICINE, THE ANTHRAX VACCINE: IS IT SAFE?
DOES IT WORK? 1-2 (2002) (J.A. 140-41) [hereinafter Institute
of Medicine Report].
Meanwhile, in July 2000, a shortage of the vaccine resulted
in a temporary suspension of DOD’s vaccination program,
causing servicemembers who had begun the six-dose regimen to
miss scheduled shots. First Am. Compl. ¶¶ 58, 59, 61; Rempfer
v. Von Eschenbach, 535 F. Supp. 2d 99, 111 (D.D.C. 2008).
According to the plaintiffs, when the suspension ended in 2002,
DOD announced that personnel whose vaccination series had
been interrupted would not repeat any doses already received
but would instead continue with the next dose in the series. First
Am. Compl. ¶¶ 63-64.
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Six servicemembers sought to enjoin the vaccination
program in 2003. Doe v. Rumsfeld, 297 F. Supp. 2d 119, 123,
130 (D.D.C. 2003). Although they did not dispute that AVA
had been approved as safe and effective against cutaneous
anthrax, they argued that it was not a licensed vaccine for
inhalational anthrax. Id. As a consequence, they maintained, 10
U.S.C. § 1107(f)(1) barred administration of the vaccine without
either informed consent or a Presidential waiver.2
Finding a likelihood of success on this claim, the district
court issued the requested preliminary injunction in December
2003. Doe, 297 F. Supp. 2d at 135. Days later, the FDA
finalized the order it had proposed in 1985, but revised it to
specify that AVA was safe and effective “independent of the
route of exposure.” Biological Products; Bacterial Vaccines and
Toxoids; Implementation of Efficacy Review, 69 Fed. Reg. 255,
260, 257-59 (Jan. 5, 2004). The district court vacated that order
for failure to comply with the notice-and-comment requirements
2
The statute provides:
In the case of the administration of an investigational new
drug or a drug unapproved for its applied use to a member
of the armed forces in connection with the member’s
participation in a particular military operation, the
requirement that the member provide prior consent to
receive the drug in accordance with the prior consent
requirement imposed under section 505(i)(4) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)(4)) may be
waived only by the President. The President may grant such
a waiver only if the President determines, in writing, that
obtaining consent is not in the interests of national security.
10 U.S.C. § 1107(f)(1).
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of the Administrative Procedure Act (APA), 5 U.S.C. § 553.
Doe v. Rumsfeld, 341 F. Supp. 2d 1 (D.D.C. 2004). The court
then issued a permanent injunction -- “unless and until FDA
follows the correct procedures to certify AVA” as safe and
effective -- against “involuntary anthrax vaccinations absent
informed consent or a Presidential waiver.” Id. at 16. The
government filed an appeal in this court.
In December 2004, the FDA issued a new proposed order
for comment. Biological Products; Bacterial Vaccines and
Toxoids; Implementation of Efficacy Review, 69 Fed. Reg.
78,281 (Dec. 29, 2004). After reviewing the comments, the
FDA issued a new final order on December 19, 2005, again
classifying AVA as safe and effective in the prevention of
anthrax regardless of the route of exposure. 2005 Final Order,
70 Fed. Reg. 75,180. In February 2006, a panel of this court
concluded that, because issuance of the new order caused the
permanent injunction to dissolve “[b]y its own terms,” the
government’s appeal was moot. Doe v. Rumsfeld, 172 Fed.
Appx. 327, 328 (D.C. Cir. 2006). In October 2006, DOD
announced resumption of the mandatory immunization program.
First Am. Compl. ¶ 48.
Thereafter, the plaintiffs in the case now before us -- eight
servicemembers subject to mandatory inoculation orders --
initiated new proceedings in the district court challenging the
FDA’s 2005 final order. First Am. Compl. ¶¶ 1-8. They also
sought to enjoin DOD from deviating from the recommended
six-shot schedule for servicemembers whose vaccinations DOD
had suspended between 2000 and 2002. The plaintiffs alleged
that any such deviation would violate 10 U.S.C. § 1107(f)(1).
Id. ¶¶ 102-12; see supra note 2. The district court resolved the
only issue raised by the plaintiffs’ three claims against the FDA
-- whether the agency’s reliance on the Brachman Study to
establish the vaccine’s effectiveness against anthrax was
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arbitrary or capricious under the APA -- in favor of the agency.
Rempfer, 535 F. Supp. 2d 99. It also dismissed the plaintiffs’
claim against DOD for lack of standing based on the plaintiffs’
failure to allege that they had been or would be subjected to off-
schedule inoculations. Id.
We review the district court’s APA ruling de novo, “as if
the agency’s decision ‘had been appealed to this court directly.’”
Gerber v. Norton, 294 F.3d 173, 178 (D.C. Cir. 2002) (quoting
Dr. Pepper/Seven-Up Cos. v. FTC, 991 F.2d 859, 862 (D.C. Cir.
1993)). We also review de novo the district court’s dismissal of
the claim against DOD for lack of standing. Muir v. Navy Fed.
Credit Union, 529 F.3d 1100, 1105 (D.C. Cir. 2008).
II
The plaintiffs’ principal challenge is to the FDA’s
determination that the anthrax vaccine is effective.3 More
specifically, they fault the FDA’s reliance on the Brachman
Study in making that determination. They argue that reliance on
that study was improper because: 1) it cannot support a finding
of effectiveness against anthrax contracted by inhalation; and 2)
it cannot support a finding of effectiveness for the current
generation of the anthrax vaccine. The plaintiffs do not contest
the vaccine’s safety.
We will consider both arguments, but first pause to correct
the plaintiffs’ misperception regarding the nature of the district
3
“Effectiveness means a reasonable expectation that, in a
significant proportion of the target population, the pharmacological or
other effect of the biological product, when used under adequate
directions, for use and warnings against unsafe use, will serve a
clinically significant function in the diagnosis, cure, mitigation,
treatment, or prevention of disease in man.” 21 C.F.R. § 601.25(d)(2).
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court’s review, and of ours, under the APA. The plaintiffs
repeatedly insist that the district court was obliged to deny the
government’s motion to dismiss because they had raised genuine
issues of material fact and hence were entitled to discovery to
flesh out their claims. But “when a party seeks review of
agency action under the APA [before a district court], the
district judge sits as an appellate tribunal.” Am. Bioscience, Inc.
v. Thompson, 269 F.3d 1077, 1083 (D.C. Cir. 2001). “The entire
case on review is a question of law,” and the “complaint,
properly read, actually presents no factual allegations, but rather
only arguments about the legal conclusion to be drawn about the
agency action.” Marshall County Health Care Auth. v. Shalala,
988 F.2d 1221, 1226 (D.C. Cir. 1993).4 Consequently,
challengers are “not . . . ordinarily entitled to augment the
agency’s record with either discovery or testimony presented in
the district court,” and there is “no inherent barrier to reaching
the merits” at the motion to dismiss stage. Id. Our review, like
that of the district court, is based on the agency record and
limited to determining whether the agency acted arbitrarily or
capriciously. See 5 U.S.C. § 706.
A
The plaintiffs first object that, because the Brachman Study
included few cases of anthrax contracted by inhalation, it cannot
support a conclusion of effectiveness against that route of
exposure. We grant the plaintiffs’ premise but disagree with
their conclusion.
4
See Am. Bioscience, 269 F.3d at 1083 (noting that, “when
reviewing agency action[,] the question of whether the agency acted
in an arbitrary and capricious manner is a legal one which the district
court can resolve on the agency record, regardless of whether it is
presented in the context of a motion for judgment on the pleadings or
in a motion for summary judgment”).
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The FDA does not dispute that, if “the cases of inhalation
anthrax reported in the course of the Brachman study [are]
analyzed separately, [they] are too few to support a meaningful
statistical conclusion.” 2005 Final Order, 70 Fed. Reg. at
75,183. But this simply directs us to the underlying issue:
should “inhalational anthrax” be analyzed separately? That
question cannot, as appellants assume, be answered as an
abstract question of statistical method. Rather, it must be
answered as a matter of scientific judgment. To illustrate: if the
route-of-exposure distinction were replaced with a time-of-
exposure distinction, no one would insist that “morning anthrax”
must be analyzed separately from “afternoon anthrax.” Yet
categorizing cases by time seems arbitrary not because time of
exposure is any less measurable a distinction than route of
exposure, but because time seems unlikely -- as a scientific
matter -- to be relevant to vaccine effectiveness.
Of course, in comparison to time of exposure, it is not as
self-evident that route of exposure is unlikely to be relevant.
After all, Dr. Brachman did flag the route-of-exposure
distinction half a century ago. Moreover, the FDA agrees that,
as a general matter, “the route of exposure to an infectious agent
may potentially have an impact on the effectiveness of a
vaccine.” Id. at 75,187.
But in the case of the anthrax vaccine, the FDA’s scientific
judgment is that route of exposure is not relevant to the
vaccine’s effectiveness. The reason, the agency explains, is as
follows:
With regard to the known pathophysiology of anthrax,
the signs and symptoms of disease arise due to the
production of toxins by anthrax bacteria growing
within the infected individual. The toxins produced by
anthrax bacteria do not vary based on the route of
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exposure. The antibodies produced in response to
vaccination contribute to the protection of the
vaccinated individual by neutralizing the activities of
those toxins. Thus, AVA elicits an antibody response
to disrupt the cytotoxic effects of toxins produced by
anthrax bacteria, regardless of the route of infection.
2005 Final Order, 70 Fed. Reg. at 75,187 (emphasis added). In
other words, AVA responds to anthrax in the same way
regardless of how the disease enters the body. Thus, for
purposes of establishing AVA’s effectiveness, the inhalational
versus cutaneous distinction is one without a difference, and
there is no need to treat them separately in interpreting the
Brachman Study. This, the FDA explains, is why it disagrees
with the 1980 advisory panel’s statement that inhalation anthrax
occurred too infrequently in the Brachman Study to provide a
basis for assessing the efficacy of AVA against that form of the
disease. Id. at 75,183; see 38 Fed. Reg. at 4321 (stating that “the
report of each panel is advisory to the Commissioner, who has
the final authority to accept or to reject the conclusions and
recommendations of the panel”).
As the FDA further notes, its judgment in this respect is in
accord with the report of the committee of experts charged by
the Institute of Medicine with conducting an independent
review. 2005 Final Order, 70 Fed. Reg. at 75,183. The
committee found that “laboratory experiments indicate that
AVA provides effective protection against inhalational
challenge in rabbits and macaques, the animal models in which
the disease is most reflective of the disease in humans.”
Institute of Medicine Report, at 10. And the committee
concluded that, “[a]s indicated by evidence from studies in both
humans and animals, . . . AVA, as licensed, is an effective
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vaccine to protect humans against anthrax, including
inhalational anthrax.” Id. at 2.5
At bottom, the plaintiffs’ claim that the Brachman Study
establishes nothing in regard to “inhalational anthrax” relies on
the proposition that route of exposure is scientifically relevant.
But the FDA’s contrary determination is a scientific judgment
within its “area of expertise,” the kind of judgment to which this
court gives a “high level of deference.” A.L. Pharma, Inc. v.
Shalala, 62 F.3d 1484, 1490 (D.C. Cir. 1995); see Serono Labs.,
Inc. v. Shalala, 158 F.3d 1313, 1320 (D.C. Cir. 1998).
Moreover, as the plaintiffs themselves concede, there is no
scientific evidence in the administrative record to contradict that
judgment. See Oral Argument Recording at 35:03.6 In the
5
The FDA found additional support for the effectiveness of the
vaccine in epidemiological data “on the occurrence of anthrax disease
in at-risk industrial settings collected by the [Centers for Disease
Control and Prevention] and summarized for the years 1962 to 1974.”
2005 Final Order, 70 Fed. Reg. at 75,183. The FDA noted that
unvaccinated persons within the at-risk populations had been infected
by anthrax during that period, but that “no cases have occurred in fully
vaccinated subjects while the risk of infection has continued.” Id.
6
At oral argument, plaintiffs’ counsel pointed to one piece of
evidence purportedly contradicting the FDA’s judgment -- a
declaration the plaintiffs filed in the district court. See J.A. 212. The
declaration was not submitted to the FDA during the administrative
proceedings and was not mentioned in the plaintiffs’ appellate briefs.
It is therefore outside the scope of our review on two accounts. See
Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 420
(1971) (holding that review is generally limited to the “record that was
before the [agency] at the time [it] made [its] decision”); Ark Las
Vegas Rest. Corp. v. NLRB, 334 F.3d 99, 108 n.4 (D.C. Cir. 2003)
(holding that arguments raised for the first time at oral argument are
waived).
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absence of such evidence, we must defer to the FDA’s judgment
that AVA is effective regardless of the route of exposure.
B
The plaintiffs’ other principal contention is that, because the
Brachman Study used an earlier generation of the anthrax
vaccine, it cannot establish the effectiveness of the current
version. We again grant the premise but reject the conclusion.
The fact that manufacturing changes occur during the
course of vaccine production is not unique to AVA, and the
FDA has an established protocol for analyzing such changes:
“[A] manufacturer may make manufacturing changes in a
product without performing additional clinical studies to
demonstrate the safety and effectiveness of the similar product
if data regarding the manufacturing changes support the
conclusion that the versions are comparable.” 2005 Final Order,
70 Fed. Reg. at 75,184. The plaintiffs maintain that “there is no
evidence within the Administrative Record that the FDA ever
compared the different anthrax vaccines and efficacy data to
reach the conclusion that the vaccines are comparable.”
Appellants’ Br. 43. But that is simply incorrect, because the
FDA did make the requisite comparability determination.
As the FDA explained in its 2005 Final Order, it “reviewed
the historical development of AVA and conclude[d] that DOD
directed the development of the vaccine, including its
formulation and manufacturing process, from the vaccine used
in the Brachman study . . . to the vaccine that was ultimately
licensed and manufactured by BioPort.” 2005 Final Order, 70
Fed. Reg. at 75,184. “All three versions of anthrax vaccine,” the
agency determined, “were tested in animals and demonstrated to
protect test animals . . . against challenge with virulent [anthrax]
spores.” Id. In addition, “clinical data comparing the safety and
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immunogenicity of [AVA] with [the DOD] vaccine . . . reveal
that the serological responses to [AVA] and [the DOD] vaccine
were similar with respect to peak antibody response and
seropositivity.” Id. That is, human blood serum showed similar
antibody production in response to the different versions of the
vaccine. Id. at 75,184, 75,192-93. The FDA also found that the
two versions were “comparable in their ability to protect test
animals.” Id. at 75,184. On this basis, the agency concluded
that the two vaccines were comparable and that the Brachman
Study could therefore be used to approve AVA. Id.
Once again, we are presented with a scientific judgment by
the FDA to which we owe considerable deference. And once
again, the plaintiffs fail to proffer any scientific evidence to
rebut it. Our conclusion must therefore be the same as above:
the FDA did not act arbitrarily or capriciously in resting a
finding of effectiveness on the results of the Brachman Study.7
III
Finally, we address the plaintiffs’ claim that DOD is
subjecting military personnel to mandatory immunization on an
unapproved schedule of inoculations. The district court
dismissed this claim on the ground that the plaintiffs lack
standing to raise it. “To establish constitutional standing, a
plaintiff must show an injury in fact that is fairly traceable to the
challenged conduct and that will likely be redressed by a
7
Scattered throughout the plaintiffs’ briefs are a number of
additional arguments criticizing the Brachman Study. Because those
arguments are raised “only summarily, without explanation or
reasoning,” they are waived. City of Waukesha v. EPA, 320 F.3d 228,
251 n.22 (D.C. Cir. 2003). In any event, we agree with the carefully
considered opinion of the district court that those additional challenges
lack merit. See Rempfer, 535 F. Supp. 2d at 108-11.
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favorable decision on the merits.” Muir, 529 F.3d at 1105
(citing Lujan v. Defenders of Wildlife, 504 U.S. 555, 560-61
(1992)). The district court concluded that the plaintiffs have not
alleged the constitutionally requisite injury in fact, and we agree.
The plaintiffs’ complaint alleges that DOD began its
program of mandatory inoculation in 1998, suspended it for
some period during 2000-02 due to a supply shortage, and then
resumed the program without correcting for the interruption in
the recommended six-shot dosage schedule. First Am. Compl.
¶¶ 10, 58-64. The plaintiffs do not allege that servicemembers
who were or will be inoculated for the first time under the post-
2002 regime will have their inoculations interrupted and
restarted off schedule. Nor do they claim that DOD is otherwise
stopping and restarting the shot sequences. Rather, they allege
that “‘[p]ersonnel whose vaccination series was interrupted
during the p[re]vious AVIP slowdown . . . . will just continue
with the next dose in the series.’” First Am. Compl. ¶ 63
(emphasis added) (quoting an Air Force statement).
As the district court noted, the plaintiffs have “not alleged
that they themselves have been, or imminently will be, subjected
to such [an interrupted] vaccination schedule.” Rempfer, 535 F.
Supp. 2d at 111. The complaint does not allege that the
inoculation sequence of any of the plaintiffs was actually
interrupted by the 2000-02 AVIP suspension. Nor have the
plaintiffs filed an affidavit to that effect. At oral argument, the
plaintiffs insisted that they are under no obligation to make such
an allegation. See Oral Argument Recording at 15:35-48.
The plaintiffs are wrong. “[I]t is the burden of the party
who seeks the exercise of jurisdiction in his favor clearly to
allege facts demonstrating that he is a proper party to invoke
judicial resolution of the dispute.” FW/PBS, Inc. v. City of
Dallas, 493 U.S. 215, 231 (1990) (internal quotations and
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citations omitted). Thus, the plaintiffs “must ‘allege . . . facts
essential to show jurisdiction. If [they] fai[l] to make the
necessary allegations, [they have] no standing.’” Id. (quoting
McNutt v. Gen. Motors Acceptance Corp., 298 U.S. 178, 189
(1936)) (alterations and omissions in original). Plaintiffs have
failed to make the necessary allegation here, and they therefore
lack standing to raise this challenge.
IV
For the foregoing reasons, the judgment of the district court
is
Affirmed.