Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caDC-11-05035/USCOURTS-caDC-11-05035-0/pdf.json

Nature of Suit Code: 890
Nature of Suit: Other Statutory Actions
Cause of Action: 

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United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued November 2, 2011 Decided March 13, 2012

No. 11-5035

COALITION FOR MERCURY-FREE DRUGS (COMED, INC.), A 

NON-PROFIT ORGANIZATION, ET AL.,

APPELLANTS

v.

KATHLEEN SEBELIUS, SECRETARY OF HEALTH AND HUMAN 

SERVICES, AND MARGARET HAMBURG, COMMISSIONER OF 

FOOD AND DRUGS,

APPELLEES

Appeal from the United States District Court

for the District of Columbia

(No. 1:09-cv-00015)

Robert E. Reeves argued the cause for appellants. With 

him on the briefs was James S. Turner.

Henry C. Whitaker, Attorney, U.S. Department of Justice, 

argued the cause for appellees. On the brief were Tony West, 

Assistant Attorney General, Ronald C. Machen, Jr., U.S. 

Attorney, and Douglas N. Letter and Catherine Y. Hancock, 

Attorneys. R. Craig Lawrence, Assistant U.S. Attorney, 

entered an appearance.

USCA Case #11-5035 Document #1363335 Filed: 03/13/2012 Page 1 of 15
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Aaron Colangelo and Vivian H.W. Wang were on the 

brief for amicus curiae Natural Resources Defense Council in 

support of neither party.

Before: ROGERS and KAVANAUGH, Circuit Judges, and 

WILLIAMS, Senior Circuit Judge.

Opinion for the Court filed by Circuit Judge KAVANAUGH.

KAVANAUGH, Circuit Judge: The Coalition for MercuryFree Drugs opposes the use of vaccines that contain 

thimerosal, a mercury-based preservative. The Coalition 

believes that vaccines containing mercury harm young 

children and pregnant women. The Coalition and several of 

its members sued to suspend Food and Drug Administration

approval of thimerosal-preserved vaccines. The District 

Court dismissed plaintiffs’ suit for lack of standing.

We recognize plaintiffs’ genuine concern about 

thimerosal-preserved vaccines. But plaintiffs are not required

to receive thimerosal-preserved vaccines; they can readily

obtain thimerosal-free vaccines. They do not have standing to 

challenge FDA’s decision to allow other people to receive

thimerosal-preserved vaccines. Plaintiffs may, of course, 

advocate that the Legislative and Executive Branches ban all

thimerosal-preserved vaccines. But because plaintiffs are 

suffering no cognizable injury as a result of FDA’s decision to 

allow thimerosal-preserved vaccines, their lawsuit is not a 

proper subject for the Judiciary. We affirm the judgment of 

the District Court.

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I

A

Vaccine manufacturers often distribute vaccines in vials

containing multiple doses. Under federal law, multiple-dose 

vials must contain a preservative so as to prevent bacterial and 

fungal contamination. See 21 C.F.R. § 610.15(a). 

Preservatives are important because injection with a 

contaminated vaccine can be fatal. See FDA, THIMEROSAL IN 

VACCINES, available at http://www.fda.gov.

Thimerosal is a mercury-based compound that FDA has 

found to be safe and effective as a vaccine preservative. See 

42 U.S.C. § 262(a)(2)(C)(i); FDA Response to Coalition

Citizen Petition at 4-5. FDA has explained that “thimerosal 

has been the subject of several studies . . . and has a long 

record of safe and effective use preventing bacterial and 

fungal contamination of vaccines, with no ill effects 

established other than minor local reactions at the site of 

injection.” FDA, THIMEROSAL IN VACCINES.

Despite FDA’s approval, some members of the public 

have expressed concern about thimerosal-preserved vaccines. 

And in 1999, “as a precautionary measure,” the Public Health 

Service (an entity within HHS) established the goal of 

removing thimerosal from early childhood vaccines. FDA 

Response to Coalition Citizen Petition at 18.1

 1 At the time, the CDC reiterated that “there are no data or 

evidence of any harm caused by the level of exposure that some 

children may have encountered in following the existing 

immunization schedule.” CDC, Notice to Readers: Thimerosal in 

Vaccines: A Joint Statement of the American Academy of 

Pediatrics and the Public Health Service, MORBIDITY AND 

MORTALITY WEEKLY REPORT (July 9, 1999), available at

 Since 2001, 

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most vaccines routinely recommended for children younger 

than six or for pregnant women have contained no thimerosal 

or only trace amounts. The significant exception is the flu 

vaccine: Thimerosal-preserved flu vaccines are necessary to 

ensure sufficient supply at a reasonable price. Therefore, flu 

vaccines with thimerosal remain on the market and are 

approved not just for adults but also for young children and 

pregnant women.

B

The Coalition for Mercury-Free Drugs and its members 

believe vaccines containing thimerosal are unsafe. They are 

especially concerned about the possible effects of thimerosalpreserved vaccines on young children and pregnant women. 

Exposure to thimerosal, plaintiffs believe, can cause 

miscarriages, autism, and other developmental disorders.

In August 2007, the Coalition submitted a “Citizen 

Petition” to FDA. The petition asked FDA to ban use of 

thimerosal-preserved vaccines for young children and 

pregnant women. The Coalition claimed that pharmaceutical 

products containing thimerosal “lack the appropriate safety 

studies.” Coalition Citizen Petition at 2. According to the 

Coalition, “substantial inferential evidence, and a growing 

body of toxicological human exposure and animal data” show 

that small amounts of thimerosal “can cause neurological and 

other tissue damage.” Id.

 

http://www.cdc.gov; cf. Paul A. Offit, Thimerosal & Vaccines – A 

Cautionary Tale, 357 NEW ENG. J. MED. 1278, 1279 (2007) 

(criticizing Joint Statement’s “precautionary” approach on the 

ground that ensuing alarm led parents to avoid vaccinations and 

take other serious risks to avoid “disproved” risk of thimerosalpreserved vaccines).

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FDA denied the Coalition’s petition. The agency stated 

that it had “applied sound scientific judgment in evaluating 

the products at issue” and had “repeatedly found that the 

vaccines and other products currently being marketed that 

contain thimerosal as a preservative are safe within the 

meaning of the” applicable statutes. FDA Response to 

Coalition Citizen Petition at 4. FDA cited numerous scientific 

studies supporting the safety of the vaccines and rebutted the 

evidence offered in the Coalition’s petition. Id. at 4-16.

The Coalition and several of its members then filed this

action in U.S. District Court. The complaint alleged that 

FDA, by allowing thimerosal-preserved vaccines, violated its 

statutory duty to ensure the safety of vaccines. Complaint at 

25-26. Plaintiffs asked for a court order requiring FDA to

prohibit the administration of vaccines containing more than a 

trace level of thimerosal to young children and pregnant 

women. Plaintiffs also sought to force FDA to remove

thimerosal-preserved vaccines from the market. Complaint at 

29-30.

The Government moved to dismiss for lack of standing 

and failure to state a claim. The District Court granted the 

motion to dismiss on the ground that the Coalition and the 

individual plaintiffs lacked standing to bring the suit. See 

Coalition for Mercury-Free Drugs v. Sebelius, 725 F. Supp. 

2d 1, 5 (D.D.C. 2010).

II

The doctrine of standing derives from Article III of the 

Constitution, which limits the jurisdiction of the federal courts 

to “Cases” and “Controversies.” U.S. CONST. art. III, § 2; 

Arizona Christian School Tuition Org. v. Winn, 131 S. Ct. 

1436, 1441-42 (2011). Standing helps differentiate “those 

disputes which are appropriately resolved through the judicial 

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process” from policy disputes that are appropriately addressed

by the elected branches. Lujan v. Defenders of Wildlife, 504 

U.S. 555, 560 (1992) (quoting Whitmore v. Arkansas, 495 

U.S. 149, 155 (1990)); see also Allen v. Wright, 468 U.S. 737, 

752 (1984) (standing rests on “a single basic idea”: the 

separation of powers). 

Permitting “courts to oversee legislative or executive 

action” without regard to the plaintiff’s personal stake in the 

litigation would “significantly alter the allocation of power 

away from a democratic form of government.” Summers v. 

Earth Island Inst., 555 U.S. 488, 493 (2009) (citation and 

ellipsis omitted); see also Winn, 131 S. Ct. at 1442. Standing 

protects democratic government by requiring citizens to 

express their generalized dissatisfaction with government 

policy through the Constitution’s representative institutions, 

not the courts. See Public Citizen v. NHTSA, 489 F.3d 1279, 

1289 (D.C. Cir. 2007) (standing “helps ensure that the 

Judicial Branch does not perform functions assigned to the 

Legislative or Executive Branch”). The requirement of 

Article III standing thus helps preserve the Constitution’s 

separation of powers and demarcates “the proper – and 

properly limited – role of the courts in a democratic society.” 

Warth v. Seldin, 422 U.S. 490, 498 (1975).

If the plaintiff does not have standing, a dispute does not 

present a justiciable case or controversy. The “judicial 

Power” conferred by Article III “exists only to redress or 

otherwise to protect against injury to the complaining party,”

not to review the legality of governmental conduct in a 

vacuum. Id. at 499; see also Valley Forge Christian Coll. v. 

Americans United for Separation of Church & State, Inc., 454

U.S. 464, 487 (1982) (federal courts are not “ombudsmen of 

the general welfare”); Marbury v. Madison, 5 U.S. 137, 170 

(1803) (the “province of the court is, solely, to decide on the 

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rights of individuals”). The doctrine of standing thus requires 

a plaintiff to demonstrate “a personal stake in the outcome of 

the controversy” in order to “justify exercise of the court’s 

remedial powers on his behalf.” Warth, 422 U.S. at 498-99 

(citation omitted).

The “irreducible constitutional minimum of standing

contains three elements”: (1) the plaintiff must have suffered 

an “injury in fact – an invasion of a legally protected interest”

that is “concrete and particularized” and “actual or 

imminent,” not abstract, generalized, remote, or speculative;

(2) there must be a “causal connection” between the injury 

and the challenged action of the defendant; and (3) it must be 

“likely,” not merely “speculative,” that the relief sought will 

redress the injury. Lujan, 504 U.S. at 560-61 (internal 

quotation marks and citations omitted).

Here, the standing of the Coalition and the individual 

members named as plaintiffs turns on the same question: 

whether any individual member of the Coalition has alleged 

facts sufficient to show Article III standing – namely, an 

injury caused by FDA’s allowing thimerosal-preserved 

vaccines and redressable by a court order that FDA no longer 

permit such vaccines. See Sierra Club v. EPA, 292 F.3d 895, 

898 (D.C. Cir. 2002) (“The issue before the court, then, is 

whether at least one member of the Sierra Club has standing 

under Article III.”).

2

 2 An association such as the Coalition has standing to sue on 

behalf of its members if: “(1) at least one of its members would 

have standing to sue in his own right, (2) the interests the 

association seeks to protect are germane to its purpose, and (3) 

neither the claim asserted nor the relief requested requires that an 

individual member of the association participate in the lawsuit.” 

Sierra Club, 292 F.3d at 898 (citing Hunt v. Wash. State Apple 

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Plaintiffs allege three kinds of injuries as the basis for 

their Article III standing: 1) physical injuries caused by 

mercury in vaccines, 2) reputational injuries to members who 

are medical professionals, and 3) difficulty in obtaining

thimerosal-free vaccines. We address each in turn.

A

Plaintiffs attribute several past injuries – including 

miscarriages, autism, and other neurological harms to children 

– to exposure of young children and pregnant women to 

thimerosal in vaccines. As the District Court correctly 

explained, however, a plaintiff who seeks prospective 

injunctive relief cannot establish standing based on past harm 

alone. Even if a plaintiff has suffered past harm from the kind

of conduct the suit seeks to enjoin, the plaintiff must 

“establish a real and immediate threat” that the harmproducing conduct will recur. City of Los Angeles v. Lyons, 

461 U.S. 95, 105 (1983).

Apparently recognizing that settled legal principle, 

plaintiffs allege a fear of future exposure to mercury from 

thimerosal-preserved vaccines. For a plaintiff seeking 

injunctive relief, however, the harm feared must be “concrete 

and particularized” and “actual or imminent, not conjectural 

or hypothetical.” Lujan, 504 U.S. at 560 (internal quotation 

marks omitted); see also Lyons, 461 U.S. at 102 (threat of 

injury must be “real and immediate”); Whitmore, 495 U.S. at 

158 (“threatened injury must be certainly impending to 

constitute injury in fact”) (internal quotation marks omitted).

But Coalition members do not claim that they intend to 

receive thimerosal-preserved vaccines in the future. On the 

contrary, they say that they will refuse thimerosal-preserved

 

Advertising Comm’n, 432 U.S. 333, 342-43 (1977)). Only the first 

element is at issue here.

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vaccines. Moreover, they acknowledge that thimerosal-free 

versions of all essential vaccines, including the flu vaccine,

are available on the market. See Pls.’ Mem. of Law in Opp’n 

to Defs.’ Mot. to Dismiss at 4 (“every prophylactic vaccine 

and biological drug product routinely recommended for 

population-wide administration to protect the public health is 

admittedly available in a form that has no added mercury 

compound”). 

In light of plaintiffs’ avowed intention to refuse

thimerosal-preserved vaccines, plaintiffs cannot show that 

they face a “certainly impending,” or even likely, risk of 

future physical injury from thimerosal in vaccines. 

To be sure, plaintiffs point out that vaccination is often 

compulsory for children whose parents seek to enroll them in 

public schools. See, e.g., Declaration of Seth Sykes at 2. But 

thimerosal-free versions of required vaccines are available, as 

plaintiffs have conceded, so parents concerned about the 

effects of thimerosal can obtain thimerosal-free vaccines for 

their school-age children.

Plaintiffs also suggest that doctors, nurses, and 

pharmacists do not pay sufficient attention to whether the flu 

vaccines they administer contain thimerosal. See, e.g.,

Declaration of Lisa Sykes at 5-7; Declaration of Jennifer Kate 

Krekeler at 5-6; Declaration of Lisa Jean Pleggenkuhle 

Grummer at 2-3; Declaration of Theresa Colleen Farris at 1-2. 

But Coalition members are aware of the difference between 

thimerosal-preserved and thimerosal-free vaccines and 

therefore can ask their doctors, nurses, and pharmacists to 

ensure that they receive only thimerosal-free vaccines. 

To establish standing, plaintiffs must allege likely future

injury to Coalition members, not to other members of the 

public. Plaintiffs have not done so.

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B

The Coalition also asserts injury to the reputations of its 

members who are medical professionals. Specifically, it 

claims that “member physicians and researchers have suffered 

injury to their reputation due to the damage done to the 

profession by the increasing evidence that the FDA has not 

been ensuring that vaccines” are safe. Coalition Br. at 35.

Coalition member Dr. Mark Geier states that he “was placed 

in the impossible position as a physician to either risk giving 

my patients a vaccine, which contained Thimerosal . . . or 

refuse to administer a ‘swine’ influenza vaccine.” Supp. 

Declaration of Mark Geier at 3.3

The short answer to this argument is that FDA is not 

forcing Dr. Geier to administer thimerosal-preserved 

vaccines, nor is it forcing any patient to receive such vaccines. 

So any reputational injury allegedly suffered by Dr. Geier is 

not legally attributable to FDA.

C

In their final and most forceful argument for standing, 

plaintiffs say that FDA’s approval of thimerosal-preserved

 3 The Coalition also submitted a declaration by researcher Dr. 

Janet Kern. Dr. Kern is not a named plaintiff, and her name does 

not appear on the membership roll placed in the record by the 

Coalition. In any event, her declaration contains no concrete, 

particularized allegation that would alter our analysis here. See 

Declaration of Janet Kern at 2, 4 (“The Secretary’s slow and 

incompetent actions related to Thimerosal are creating the potential 

for a public health crisis due to distrust of the health care 

system. . . . Forcing the FDA to do its job will begin to restore 

public confidence in the medical community including myself.”).

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vaccines has made it more difficult and costly for Coalition

members to find and obtain thimerosal-free vaccines. 

This Court has permitted consumers of a product to 

challenge agency action that prevented the consumers from 

purchasing a desired product. In Consumer Federation of 

America v. FCC, for example, this Court held that a consumer 

group had standing to challenge the FCC’s approval of the 

AT&T-Comcast merger. 348 F.3d 1009, 1012 (D.C. Cir. 

2003). In that case, a member of the consumer group alleged 

that the merger would prevent him from subscribing to 

Comcast’s high-speed internet service while retaining the 

ability to choose his own internet service provider. Id. The 

Court stated that the “inability of consumers to buy a desired 

product may constitute injury-in-fact even if they could 

ameliorate the injury by purchasing some alternative 

product.” Id. (internal quotation marks omitted); see also 

Chamber of Commerce v. SEC, 412 F.3d 133, 136-38 (D.C. 

Cir. 2005) (lost opportunity to purchase shares in mutual 

funds with less than 75% independent directors); Competitive 

Enterprise Inst. v. NHTSA, 901 F.2d 107, 112-13 (D.C. Cir. 

1990) (lost opportunity to purchase larger vehicles); Center 

for Auto Safety v. NHTSA, 793 F.2d 1322, 1332-34 (D.C. Cir. 

1986) (lost opportunity to purchase more fuel-efficient 

vehicles).

But here, plaintiffs do not allege that FDA’s approval of

thimerosal-preserved vaccines prevents them from purchasing

thimerosal-free vaccines altogether. Rather, plaintiffs

concede that mercury-free versions are available. 

Under our precedents, that does not end the analysis, 

however, for plaintiffs also contend that FDA’s approval of 

thimerosal-preserved vaccines makes thimerosal-free 

alternatives difficult to obtain, because clinics and doctors do 

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not consistently carry them. See Pls.’ Mem. of Law in Opp’n 

to Defs.’ Mot. to Dismiss at 13-15. That asserted injury bears 

some marginal resemblance to the injury alleged in Public 

Citizen v. Foreman, 631 F.2d 969 (D.C. Cir. 1980). In 

Foreman, a consumer advocacy group and two of its members

challenged FDA’s approval of the use of nitrites as a 

preservative in cured bacon. See id. at 973-74. The plaintiffs 

did not claim that nitrite-free bacon was completely

unavailable on the market, but they did “allege that the nitritefree bacon they seek is not readily available at a reasonable 

price.” Id. at 974 n.12 (emphasis added). The Court held that 

the plaintiffs had standing. It reasoned that although “this 

injury may not be overly burdensome . . . , it is an injury 

nonetheless.” Id.

Here, however, plaintiffs’ complaint and declarations do 

not allege that mercury-free vaccines are “not readily 

available.” On the contrary, the declarations acknowledge

that thimerosal-free vaccines are readily available. For 

example, the declaration submitted by Coalition member Lisa 

Sykes describes her visit to a CVS pharmacy in Richmond, 

Virginia, where a nurse practitioner “explained that she had 

two types of flu vaccine, with and without Thimerosal, if I 

was worried about that.” Declaration of Lisa Sykes at 4. 

Similarly, Dr. Mark Geier’s declaration reports that a Safeway 

pharmacy in Silver Spring, Maryland, maintained “a 

significant stock” of both thimerosal-preserved and 

thimerosal-free vaccines. Declaration of Mark Geier at 3-5; 

see also Declaration of Larry Hanus at 3 (Walgreens 

pharmacy offered to order thimerosal-free vaccine overnight); 

Declaration of Melissa Renee Troutman at 3 (pharmacy 

offered to order thimerosal-free vaccine, which “would take 

about a week” to arrive).

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To be sure, other Coalition members describe visits to 

individual pharmacies and clinics that did not have 

thimerosal-free formulations on hand. See, e.g., Declaration 

of Sarah W. Cooleen at 3 (“I asked him if you could order a 

thimerosal free shot. He said they couldn’t just order one shot 

and I should check with other Kroger stores.”). But the 

unavailability of thimerosal-free vaccines at a few individual 

outlets does not come close to establishing that they are “not 

readily available.”4

Nor do plaintiffs allege that thimerosal-free vaccines are 

unreasonably priced as a result of FDA’s decision to allow

thimerosal-preserved vaccines. Cf. Foreman, 631 F.2d at 974 

n.12. Some of the declarations do suggest that thimerosalfree vaccines cost more than thimerosal-preserved vaccines. 

See, e.g., Declaration of Lisa Sykes at 7 (“The vaccine with 

the preservative cost less than the one without it.”); 

Declaration of Melissa Renee Troutman at 3 (pharmacist 

stating that pharmacy could order thimerosal-free vaccine, but 

“it does cost more”); Declaration of Erin Grace Lewis at 3

(pharmacy owner stating that pharmacy did not order 

thimerosal-free vaccines “because they are more expensive” 

than vaccines containing trace amounts of thimerosal). But 

 4 The Coalition’s brief states, without further detail or citation, 

that Coalition member Linda Weinmaster “was not able to get 

vaccines completely free of Thimerosal for swine flu or seasonal 

flu” for her son Adam in the 2009-2010 flu season “despite her 

desire to do so,” and that “she anticipates this may be a problem 

again this fall and winter.” Coalition Br. at 19. We find no 

statement to that effect in plaintiffs’ complaint or in either of Mrs. 

Weinmaster’s declarations that were before the District Court. In 

any event, that isolated statement, without any description of the 

efforts Mrs. Weinmaster undertook to obtain a thimerosal-free flu 

vaccine, does not indicate that such vaccines are “not readily 

available.” Foreman, 631 F.2d at 974 n.12.

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see Declaration of Larry Hanus at 3 (no difference in price at 

Wal-Mart pharmacy).

But even if vaccine providers generally charge a higher 

price for thimerosal-free vaccines, the mere existence of a 

price differential would not establish that thimerosal-free 

vaccines are “not readily available at a reasonable price.” 

Foreman, 631 F.2d at 974 n.12 (emphasis added). The price 

might be higher for the simple reason that things packaged 

individually (like thimerosal-free vaccines, which are 

packaged in single doses) generally cost more than the same 

things packaged in bulk (like thimerosal-preserved vaccines, 

which are packaged in multi-dose vials). See 21 C.F.R. 

§ 610.15(a) (“[p]roducts in multiple-dose containers shall 

contain a preservative”); FDA, THIMEROSAL IN VACCINES

tbl.1 (approved thimerosal-free influenza vaccines are 

packaged in single doses).

And the price differential might be sufficiently small as 

to have little effect on the vaccine’s affordability for the 

average person. In any event, plaintiffs’ declarations claim 

only that there was some price differential at a few individual 

outlets. The question under this aspect of Foreman is whether 

thimerosal-free vaccines are unreasonably priced. Plaintiffs 

have not alleged facts demonstrating as much. And we 

decline to stretch Foreman to hold that any alleged 

discrepancy in price between a preferred product and a more 

widely available one, no matter how small, confers Article III 

standing to seek an order banning the more widely available

product.5

 5 At oral argument, the Government suggested that the 

plaintiffs’ desired relief – a court order banning thimerosalpreserved vaccines – would result in a sudden, drastic reduction in 

the overall availability of flu vaccine. Presumably, a side effect of 

that contraction would be a significant increase in the price of the 

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* * *

We recognize plaintiffs’ concerns about thimerosal. But 

plaintiffs have not alleged that Coalition members face likely 

future injury caused by FDA’s refusal to ban thimerosalpreserved vaccines. The Constitution therefore requires that 

they direct their objections to the Executive and Legislative 

Branches, not to the Judiciary.

We affirm the District Court’s judgment dismissing 

plaintiffs’ suit for lack of standing.

 

limited stock of thimerosal-free vaccines. Therefore, according to 

the Government, a court order would not redress plaintiffs’ claimed 

injury. Because we hold that plaintiffs have not alleged a 

cognizable injury-in-fact under Foreman, we need not reach that 

separate argument advanced by the Government for lack of 

redressability.

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