PUBLISHED
UNITED STATES COURT OF APPEALS
FOR THE FOURTH CIRCUIT
MARY SCOTT DOE, a human
embryo "born" in the United
States (and subsequently frozen in
which state of cryopreservation
her life is presently suspended),
individually and on behalf of all
other frozen human embryos
similarly situated; NATIONAL
ORGANIZATION FOR EMBRYONIC LAW
(NOEL); NIGHTLIGHT CHRISTIAN
ADOPTIONS; PETER MURRAY;
SUZANNE MURRAY; COURTNEY
ATNIP; TIM ATNIP; STEVEN B.
JOHNSON; KATE ELIZABETH JOHNSON;
CORA BEST; GREGORY BEST, No. 10-1104
Plaintiffs-Appellants,
v.
BARACK HUSSEIN OBAMA, in his
official capacity as President of
the United States; CHARLES E.
JOHNSON, in his official capacity as
acting secretary of the Department
of Health & Human Services;
RAYNARD S. KINGTON, in his
official capacity as acting director
of the National Institutes of
Health,
Defendants-Appellees.
2 DOE v. OBAMA
MARY SCOTT DOE, a human
embryo "born" in the United
States (and subsequently frozen in
which state of cryopreservation
her life is suspended), individually
and on behalf of all other frozen
human embryos similarly situated;
NATIONAL ORGANIZATION FOR
EMBRYONIC LAW (NOEL); PETER
MURRAY; SUZANNE MURRAY;
COURTNEY ATNIP; TIM ATNIP;
STEVEN B. JOHNSON; KATE
ELIZABETH JOHNSON; CORA BEST; No. 10-1106
GREGORY BEST,
Plaintiffs-Appellants,
v.
KATHLEEN SEBELIUS, In her official
capacity as Secretary of the
Department of Health & Human
Services; FRANCIS S. COLLINS, In
his official capacity as director of
the National Institutes of Health,
Defendants-Appellees.
Appeals from the United States District Court
for the District of Maryland, at Greenbelt.
Alexander Williams, Jr., District Judge.
(8:09-cv-00755-AW; 8:09-cv-02197-AW)
Argued: December 7, 2010
Decided: January 21, 2011
DOE v. OBAMA 3
Before TRAXLER, Chief Judge, and WILKINSON and
SHEDD, Circuit Judges.
Affirmed by published opinion. Judge Wilkinson wrote the
opinion, in which Chief Judge Traxler and Judge Shedd
joined.
COUNSEL
ARGUED: Rudolph Martin Palmer, Jr., Hagerstown, Mary-
land, for Appellants. Benjamin Seth Kingsley, UNITED
STATES DEPARTMENT OF JUSTICE, Washington, D.C.,
for Appellees. ON BRIEF: Tony West, Assistant Attorney
General, Mark B. Stern, UNITED STATES DEPARTMENT
OF JUSTICE, Washington, D.C., Rod J. Rosenstein, United
States Attorney, Baltimore, Maryland, for Appellees.
OPINION
WILKINSON, Circuit Judge:
Plaintiffs in this case challenge the federal funding of
research involving embryonic stem cells. The district court
dismissed the suit for want of standing. We appreciate the
sensitivity of the underlying issue and respect the sincerity of
arguments on all sides of the question. However, as a matter
of law, the principles of standing enunciated by the Supreme
Court mandate an affirmance of the judgment.
I.
Human embryonic stem cells (hESCs) are valued by scien-
tific researchers for their ability to transform into any type of
4 DOE v. OBAMA
cell in the human body. They are derived from embryos,
largely embryos created via in vitro fertilization (IVF) for
reproductive purposes and donated for research when no lon-
ger needed for that reason. The process of creating hESCs
generally results in the destruction of the embryo. Embryos
not donated for research can also be made available for adop-
tion.
In addition to technical discussions, the issue of stem cell
research has elicited debate on the role of science in alleviat-
ing human suffering and the relationship of science to the
sanctity of life. Federal funding guidelines have not surpris-
ingly proven controversial. Although hESCs have been avail-
able for research since 1998, the National Institutes of Health
(NIH) did not fund research involving hESCs until 2001. That
funding, however, was restricted to research involving hESCs
derived from stem cell lines already in existence. See Address
to the Nation on Stem Cell Research from Crawford, Tex., 37
Weekly Comp. Pres. Doc. 1149 (Aug. 9, 2001); see also
Exec. Order No. 13435, 72 Fed. Reg. 34591 (June 20, 2007).
On March 9, 2009, President Obama issued Executive Order
13505, 74 Fed. Reg. 10667, removing that restriction and
expanding federal funding of hESC research. Executive Order
13505 also directed the NIH to issue new guidelines on that
research. The NIH responded on July 7, 2009 with final
Guidelines for Human Stem Cell Research ("NIH Guide-
lines"). 74 Fed. Reg. 32170.
Two sets of plaintiffs in these consolidated cases challenge
Executive Order 13505 and the NIH Guidelines. Plaintiff
Mary Scott Doe represents a putative class of all frozen
embryos held throughout the United States for either research
or adoption purposes. The other plaintiffs are several parents
who have children that were adopted as frozen embryos and
who are considering adopting embryos again. Together, plain-
tiffs argue that the new hESC policies violate the Thirteenth
and Fourteenth Amendments, the Administrative Procedure
Act, and the Dickey-Wicker Amendment, Pub. L. No. 111-8,
DOE v. OBAMA 5
div. F, Title V, § 509(a)(2), 123 Stat. 524, 803, a restriction
on NIH funding which bars the use of federal funds for "re-
search in which a human embryo or embryos are destroyed,
discarded, or knowingly subjected to risk of injury or death."
The district court dismissed both lawsuits for lack of standing.
Plaintiffs now appeal.
II.
We are not at liberty to resolve every grievance over gov-
ernment policy, no matter how significant, for "Article III of
the Constitution confines the federal courts to adjudicating
actual ‘cases’ and ‘controversies.’" Allen v. Wright, 468 U.S.
737, 750 (1984). The Supreme Court has made clear that
"standing is an essential and unchanging part" of that case-or-
controversy requirement, Lujan v. Defenders of Wildlife, 504
U.S. 555, 560 (1992), one that "state[s] fundamental limits on
federal judicial power in our system of government," Allen,
468 U.S. at 750. To satisfy that constitutional requirement, a
plaintiff must demonstrate:
(1) it has suffered an "injury in fact" that is (a) con-
crete and particularized and (b) actual or imminent,
not conjectural or hypothetical; (2) the injury is
fairly traceable to the challenged action of the defen-
dant; and (3) it is likely, as opposed to merely specu-
lative, that the injury will be redressed by a favorable
decision.
Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC),
Inc., 528 U.S. 167, 180-81 (2000). We review de novo the
district court’s decision to dismiss for lack of standing. Bishop
v. Bartlett, 575 F.3d 419, 423 (4th Cir. 2009).
III.
Plaintiffs first assert that the class of all human embryos
currently held at IVF clinics throughout the country, including
6 DOE v. OBAMA
named plaintiff Mary Scott Doe, have standing to assert their
constitutional and statutory rights.
A.
Plaintiffs contend that the class of frozen embryos is threat-
ened with injury sufficient for standing because Executive
Order 13505 and the NIH Guidelines increase the embryos’
risk of being reduced to embryonic stem cells. By itself, this
contention is insufficient. The Supreme Court has made clear
that "named plaintiffs who represent a class ‘must allege and
show that they personally have been injured, not that injury
has been suffered by other, unidentified members of the class
to which they belong and which they purport to represent.’"
Simon v. E. Ky. Welfare Rights Org., 426 U.S. 26, 40 n.20
(1976) (quoting Warth v. Seldin, 422 U.S. 490, 501 (1975)).
Without a sufficient allegation of harm to the named plaintiff
in particular, plaintiffs cannot meet their burden of establish-
ing standing.
We cannot identify a particularized harm because the com-
plaint does not identify any of the named plaintiff’s particu-
larized characteristics. Instead, it leaves us only with
questions such as whether the embryo will ever be used for
research and whether that research will be funded by the NIH.
We have no idea under what terms the named plaintiff
embryo was donated or stored or what its status even is. In the
absence of answers, the chosen appellation of Mary Scott Doe
could equally designate any member of an amorphous frozen
embryo class. Indeed, the complaint even states that Mary
Scott Doe may be one of the embryos donated for adoption.*
*Plaintiffs reversed course in a subsequent motion before this court,
arguing that the named plaintiff is actually a construct "representing the
next human embryo to be vivisected in the nation at any given moment of
time." Motion for Preventive Injunction at 10. Even if such hypothetical
litigants could have standing, this one cannot lest Simon’s instruction that
"named plaintiffs who represent a class must allege and show that they
personally have been injured," be rendered a nullity. 426 U.S. at 40 n.20
(internal quotation omitted).
DOE v. OBAMA 7
JA 15. Because the class of frozen embryos includes several
subsets, we have no way of knowing whether "the claims or
defenses of the representative part[y] are typical of the claims
or defenses of the class," Fed. R. Civ. P. 23(a)(3), which is to
say whether the named plaintiff is threatened with the harm
plaintiffs impute to the class as a whole.
While plaintiffs attempt to bypass the requirement of par-
ticularized harm by asserting that all frozen embryos are
threatened with harm, this is not a sound contention. The NIH
Guidelines permit funding for research involving only stem
cells from embryos "donated by individuals who sought
reproductive treatment . . . and who gave voluntary written
consent for the human embryos to be used for research pur-
poses." 74 Fed. Reg. at 32174. Plaintiffs offer no reason to
think, for example, that embryos already donated for adoption
are at any risk for the injury allegedly caused by the Guide-
lines. Moreover, the complaint provides no basis to conclude
that the named plaintiff in particular will be part of the subset
that suffers any injury at all, much less an injury due to the
challenged government policy. Because the injury-in-fact test
requires "that the party seeking review be himself among the
injured," Sierra Club v. Morton, 405 U.S. 727, 735 (1972), we
cannot conclude that these plaintiffs have alleged a "concrete
and particularized" harm, Friends of the Earth, 528 U.S. at
180.
B.
There is an additional difficulty with the embryo plaintiffs’
claim of standing. "[T]he ‘case or controversy’ limitation of
Art. III still requires that a federal court act only to redress
injury that fairly can be traced to the challenged action of the
defendant, and not injury that results from the independent
action of some third party not before the court." Simon, 426
U.S. at 41-42. Here, the NIH Guidelines restrict funding to
research involving stem cells "[t]hat were created using in
vitro fertilization for reproductive purposes and were no lon-
8 DOE v. OBAMA
ger needed for this purpose" and "[t]hat were donated by indi-
viduals who sought reproductive treatment . . . and who gave
voluntary written consent for the human embryos to be used
for research purposes." 74 Fed. Reg. at 32174. Thus, the inde-
pendent decision of biological parents to donate embryos for
research is an intervening cause of the injury that plaintiffs
assert on behalf of the embryos.
The conclusion that the injury asserted is not fairly trace-
able to Executive Order 13505 or the NIH Guidelines follows
from the Supreme Court’s pronouncements. In Allen, the
Court addressed an allegation that the Internal Revenue Ser-
vice (IRS) failed to ensure that racially discriminatory private
schools were denied tax-exempt status. Though the plaintiffs
had suffered a cognizable injury in the form of a reduced abil-
ity to attend a racially integrated school, the conclusion that
"withdrawal of a tax exemption from any particular school
would lead the school to change its policies" or that "any
given parent of a child attending such a private school would
decide to transfer the child to a public school as a result" was
"entirely speculative." 468 U.S. at 758.
Likewise in Simon, the Court found it "purely speculative"
to conclude that nonprofit hospitals would provide expanded
care to indigent patients if their tax-exempt status were threat-
ened. 426 U.S. at 42-43. Allen and Simon illustrate a funda-
mental tenet of standing doctrine: where a third party such as
a private school or hospital makes the independent decision
that causes an injury, that injury is not fairly traceable to the
government. Here, the mere fact that the government permits
private donors to choose to donate their embryos for research
does not therefore make that decision fairly traceable to Exec-
utive Order 13505 or the NIH Guidelines.
Plaintiffs recognize the role of the biological parents’ deci-
sion, but nevertheless maintain that the decision is not truly
independent. In their view, "the decisions of genetic parents
of embryos whether or not to donate their unused embryos for
DOE v. OBAMA 9
experimentation will be powerfully influenced" by the addi-
tional funding available under the new policy. Brief of Appel-
lants at 43. But this argument cannot salvage plaintiffs’ claim
that any injury is fairly traceable to the challenged policies.
The NIH Guidelines already acknowledge the possibility
that researcher demand for embryos driven by additional
funding could influence the decision of biological parents to
donate their embryos for research, and address that concern
with several strict conditions. First, the Guidelines require that
"[n]o payments, cash or in kind, [be] offered for the donated
embryos." 74 Fed. Reg. at 32174. Second, they demand that
"[p]olicies and/or procedures [be] in place at the health care
facility where the embryos [are] donated that neither consent-
ing nor refusing to donate embryos for research would affect
the quality of care provided to potential donor(s)." Id. Third,
the Guidelines require a "clear separation" between the deci-
sions to create embryos and to donate them, a separation
requiring that "[d]ecisions related to the creation of human
embryos for reproductive purposes [be] made free from the
influence of researchers proposing to derive or utilize hESCs
in research." Id. Where government policy not only allows the
biological parents to choose what to do with their embryos,
but also safeguards the independence of their decision with
strict conditions, the connection between injury and policy is
a "purely speculative" one. Simon, 426 U.S. at 42.
IV.
Plaintiffs also assert that the parents who "are actively con-
sidering adopting" human embryos have standing to challenge
Executive Order 13505 and the NIH Guidelines. Assuming,
without deciding, that these parents are proper parties to bring
claims on behalf of the embryos, the parents themselves still
must show the "irreducible constitutional minimum" of an
injury in fact that is "‘fairly . . . trace[able] to the challenged
action of the defendant’" and that will likely be "‘redressed by
10 DOE v. OBAMA
a favorable decision.’" Lujan, 504 U.S. at 560-61 (alterations
in original) (quoting Simon, 426 U.S. at 38, 41).
A.
The parents do not allege that they have already suffered an
injury. Instead, they claim that they face the threat of a future
injury, namely that implementation of Executive Order 13505
will "reduce the number of in vitro human embryos available
for adoption" such that they will be unable to adopt. Brief of
Appellants at 53. However, they do not allege facts from
which we can infer that such an injury would be "actual or
imminent." Lujan, 504 U.S. at 564.
In Lujan, the Supreme Court addressed an analogous
injury. There two plaintiffs challenged a regulation that inter-
preted a provision of the Endangered Species Act not to apply
to foreign nations. The plaintiffs claimed to have standing
because they had visited other countries to observe endan-
gered species and intended to do so again in the future. Id. at
563-64. The Supreme Court found these indefinite plans
insufficient to confer standing: "Such ‘some day’ inten-
tions—without any description of concrete plans, or indeed
even any specification of when the some day will be—do not
support a finding of the ‘actual or imminent’ injury that our
cases require." Id. at 564.
Lujan’s requirement that plaintiffs have some concrete plan
constrains us here. The entirety of plaintiffs’ allegation in the
complaint is that some of the parents "continue to consider the
adoption of and/or seek to adopt additional in vitro human
embryos." JA 43. Although "[a]t the pleading stage, general
factual allegations of injury resulting from the defendant’s
conduct may suffice," Lujan, 504 U.S. at 561, plaintiffs are
not excused from the constitutional prerequisite of alleging an
injury that "is ‘certainly impending,’" id. at 565 n.2 (emphasis
in original) (quoting Whitmore v. Arkansas, 495 U.S. 149, 158
(1990)). The imminence requirement is "stretched beyond the
DOE v. OBAMA 11
breaking point when, as here, the plaintiff alleges only an
injury at some indefinite future time, and the acts necessary
to make the injury happen are at least partly within the plain-
tiff’s own control." Id. Thus the Supreme Court has "insisted
that the injury proceed with a high degree of immediacy, so
as to reduce the possibility of deciding a case in which no
injury would have occurred at all." Id. The plaintiff parents
here did not allege that they have already tried and failed to
adopt embryos, nor do they allege any concrete plans for
future adoption, so the possibility that they will never suffer
the alleged injury looms too large.
B.
Moreover, like the class of frozen embryos, the plaintiff
parents cannot establish that the claimed injury is fairly trace-
able to Executive Order 13505 or the NIH Guidelines. As the
district court correctly noted, "it is the donor’s choice which
could potentially reduce the number of human embryos for
adoption and not the Defendants’ conduct which ‘causes’
Plaintiffs’ alleged injury." JA 324. The parents’ claim of
standing thus falters for largely the same reasons identified in
part III.B. supra.
V.
Our conclusion that plaintiffs cannot establish standing in
this case is a narrow one, for we do not suggest that no party
would ever have standing to assert similar claims. The bar of
standing must not be set too high, lest many regulatory
actions escape review contrary to the intent of Congress. See
Administrative Procedure Act, 5 U.S.C. § 702 ("A person suf-
fering legal wrong because of agency action, or adversely
affected or aggrieved by agency action within the meaning of
a relevant statute, is entitled to judicial review thereof.").
A complaint that provided more concrete information about
the identity of the named plaintiff embryo or the plaintiff par-
12 DOE v. OBAMA
ents’ plans for adoption would at least address more directly
what the Supreme Court has identified as serious constitu-
tional concerns. A sister circuit has concluded that certain sci-
entists who compete directly with hESC researchers for NIH
funding have "competitor standing" to bring related claims.
See Sherley v. Sebelius, 610 F.3d 69 (D.C. Cir. 2010). The
Sherley plaintiffs were doctors that "specialize in adult stem
cell research," id. at 71, and in order to compete with embry-
onic stem cell researchers for NIH funding, they would "have
to invest more time and resources to craft a successful grant
application," id. at 74. That injury—an increased risk that a
government agency would choose not to fund the doctors’
research—is not alleged here. See id. at 72.
We express no opinion on the standing issue in Sherley or
any other case not presently before this court, but simply note
that such cases are different from the one that is before us. In
the absence of a showing that the Supreme Court’s require-
ments for standing have been met in this particular case, the
complaint presents what is essentially a policy dispute over
the administration’s approach to stem cell research. We do not
doubt for a moment the sincerity of those who oppose, as well
as those who support, the revised NIH funding guidelines. But
depth of conviction, while admirable, cannot serve to displace
the courts’ own deep attachment to the law. "Recognition of
standing in such circumstances would transform the federal
courts" into more political organs, less differentiated from the
workings of the political branches whose actions we are now
requested to review. See Allen, 468 U.S. at 756. Because
"[c]onstitutional limits on the role of the federal courts pre-
clude such a transformation," id., we affirm the judgment of
the district court.
AFFIRMED