Coalition for Mecury Free Drug v. Kathleen Sebeliu
Filing
OPINION filed [1363335] (Pages: 15) for the Court by Judge Kavanaugh [11-5035]
USCA Case #11-5035
Document #1363335
Filed: 03/13/2012
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.
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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 Since 2001,
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
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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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