Rempfer v. Sharfstein

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.