Sherley v. Sebelius

United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued December 6, 2010 Decided April 29, 2011

No. 10-5287

DR. JAMES L. SHERLEY, ET AL.,
APPELLEES

v.

KATHLEEN SEBELIUS, IN HER OFFICIAL CAPACITY AS
SECRETARY OF THE DEPARTMENT OF HEALTH AND HUMAN
SERVICES, ET AL.,
APPELLANTS

Appeal from the United States District Court
for the District of Columbia
(No. 1:09-cv-01575)

Beth S. Brinkmann, Deputy Assistant Attorney General,
U.S. Department of Justice, argued the cause for appellants.
With her on the briefs were Ronald C. Machen Jr., U.S.
Attorney, and Mark B. Stern, Stephanie R. Marcus, and Abby
C. Wright, Attorneys. Joel McElvain, Senior Counsel, and R.
Craig Lawrence, Assistant U.S. Attorney, entered
appearances.
 2
Jon E. Pettibone, Neal Goldfarb, and Andrew T. Karron
were on the brief for amici curiae State of Wisconsin, et al. in
support of appellants.

Robert P. Charrow and Laura Metcoff Klaus were on the
brief for amicus curiae Regents of the University of
California in support of appellants.

Thomas G. Hungar argued the cause for appellees. With
him on the brief were Bradley J. Lingo, Thomas M. Johnson,
Jr., Ryan J. Watson, Blaine H. Evanson, Samuel B. Casey,
and Steven H. Aden.

Dorinda C. Bordlee was on the brief for amicus curiae
Maureen L. Condic in support of appellee.

Before: GINSBURG, HENDERSON, and GRIFFITH, Circuit
Judges.

Opinion for the Court filed by Circuit Judge GINSBURG.

Dissenting opinion filed by Circuit Judge HENDERSON.

GINSBURG, Circuit Judge: Two scientists brought this
suit to enjoin the National Institutes of Health from funding
research using human embryonic stem cells (ESCs) pursuant
to the NIH’s 2009 Guidelines. The district court granted their
motion for a preliminary injunction, concluding they were
likely to succeed in showing the Guidelines violated the
Dickey-Wicker Amendment, an appropriations rider that bars
federal funding for research in which a human embryo is
destroyed. We conclude the plaintiffs are unlikely to prevail
because Dickey-Wicker is ambiguous and the NIH seems
reasonably to have concluded that, although Dickey-Wicker
bars funding for the destructive act of deriving an ESC from
 3
an embryo, it does not prohibit funding a research project in
which an ESC will be used. We therefore vacate the
preliminary injunction.

I. Background

As we explained at an earlier stage of this case, stem cells
have the potential of yielding treatments for a wide range of
afflictions because scientists can cause them to function as
any one of a number of specific types of cell. 610 F.3d 69, 70
(2010) (Sherley I). We there considered two different classes
of human stem cells: adult stem cells, which are somewhat
specialized, and ESCs, which are pluripotent, meaning they
can develop into nearly any of the 200 types of human cell.
In addition to these two established categories, we note the
recent development of induced pluripotent stem cells, which
are adult stem cells reprogrammed to a stage of development
at which they are pluripotent. There is some debate as to
which type of stem cell holds more promise of yielding
therapeutic applications.

Adult stem cells can be found in the various tissues and
organs of the human body. ESCs, by contrast, can be found
only in a human embryo; isolating an ESC requires removing
the “inner cell mass” of the embryo, a process that destroys
the embryo. The stem cells among the 30 or so cells in the
inner cell mass are then placed in a culture, where they will
divide continuously without differentiating, thus forming a
“stem cell line” of identical cells. An individual ESC may be
removed from the line without disrupting either the
multiplication process or the durability of the line. The
removed cell may then be used in a research project — either
by the investigator who extracted it or by another — in which
the ESC will be caused to develop into the type of cell
pertinent to that research. Most stem cell lines are maintained
 4
by one or another of several research universities, which make
them available for scientific use, usually for a small fee.

The plaintiffs in this case, Drs. James Sherley and
Theresa Deisher, are scientists who use only adult stem cells
in their research. They contend the NIH has, by funding
research projects using ESCs, violated the Dickey-Wicker
Amendment, which the Congress has included in the annual
appropriation for the Department of Health and Human
Services each year since 1996. Dickey-Wicker prohibits the
NIH from funding:

(1) the creation of a human embryo or embryos
for research purposes; or (2) research in which
a human embryo or embryos are destroyed,
discarded, or knowingly subjected to risk of
injury or death greater than that allowed for
research on fetuses in utero under 45 C.F.R.
46.204(b) and section 498(b) of the Public
Health Service Act (42 U.S.C. 289g(b)).

Pub. L. No. 111-117, § 509(a)(2), 123 Stat. 3034, 3280–81.

In 1996, when the Congress first passed Dickey-Wicker,
scientists had taken steps to isolate ESCs but had not yet been
able to stabilize them for research in the laboratory. The
historical record suggests the Congress passed the
Amendment chiefly to preclude President Clinton from acting
upon an NIH report recommending federal funding for
research using embryos that had been created for the purpose
of in vitro fertilization. See O. Carter Snead, Science, Public
Bioethics, and the Problem of Integration, 43 U.C. DAVIS L.
REV. 1529, 1546 (2010). Dickey-Wicker became directly
relevant to ESCs only in 1998, when researchers at the
University of Wisconsin succeeded in generating a stable line
 5
of ESCs, which they made available to investigators who
might apply for NIH funding.

For that reason, on January 15, 1999, the General
Counsel of the Department of Health and Human Services
issued a memorandum addressing whether Dickey-Wicker
permits federal funding of research using ESCs that had been
derived before the funded project began; she concluded such
funding is permissible because ESCs are not “embryos.”
After notice and comment, the NIH issued funding guidelines
consistent with this opinion, see 65 Fed. Reg. 51,976 (2000),
but the NIH did not fund any ESC research project while
President Clinton was in office.

Early in 2001, President Bush directed the NIH not to
fund any project pursuant to President Clinton’s policy; later
that year he decided funding for ESC research would be
limited to projects using the approximately 60 then-extant cell
lines derived from “embryos that ha[d] already been
destroyed.” See 37 WEEKLY COMP. PRES. DOC. 1149, 1151
(Aug. 9, 2001); see also Exec. Order No. 13,435, 72 Fed.
Reg. 34,591 (2007); Doe v. Obama, 631 F.3d 157, 159 (4th
Cir. 2011). Meanwhile, the Congress continued to reenact
Dickey-Wicker each year of the Bush Administration.

Upon assuming office in 2009, President Obama lifted
the temporal restriction imposed by President Bush and
permitted the NIH to “support and conduct responsible,
scientifically worthy human stem cell research, including
human embryonic stem cell research, to the extent permitted
by law.” Exec. Order 13,505, 74 Fed. Reg. 10,667, 10,667
(2009). The NIH, after notice-and-comment rulemaking, then
issued the 2009 Guidelines, 74 Fed. Reg. 32,170–32,175 (July
7, 2009), which are currently in effect. In the Guidelines, the
NIH noted “funding of the derivation of stem cells from
 6
human embryos is prohibited by ... the Dickey-Wicker
Amendment.” Id. at 32,175/2. The Guidelines further
addressed Dickey-Wicker as follows:

Since 1999, the Department of Health and
Human Services (HHS) has consistently
interpreted [Dickey-Wicker] as not applicable
to research using [ESCs], because [ESCs] are
not embryos as defined by Section 509. This
longstanding interpretation has been left
unchanged by Congress, which has annually
reenacted the Dickey [sic] Amendment with
full knowledge that HHS has been funding
[ESC] research since 2001. These guidelines
therefore recognize the distinction, accepted by
Congress, between the derivation of stem cells
from an embryo that results in the embryo’s
destruction, for which Federal funding is
prohibited, and research involving [ESCs] that
does not involve an embryo nor result in an
embryo’s destruction, for which Federal
funding is permitted.

Id. at 32,173/2.

In place of President Bush’s temporal limitation, the 2009
Guidelines instituted specific ethical restrictions upon ESC
research funded by the NIH: Such research may be conducted
only upon stem cell lines derived from embryos that “were
created using in vitro fertilization for reproductive purposes
and were no longer needed for this purpose,” and that “were
donated by individuals who sought reproductive treatment ...
who gave voluntary written consent for the human embryos to
be used for research purposes,” and who were not paid
therefor. Id. at 32,174/2–3. Moreover, the research may use
 7
stem cell lines derived from an embryo donated after the
effective date of the Guidelines only if the in vitro clinic had
fully informed the donor of all possible options for disposing
of the embryo and had taken other specified procedural steps
to separate reproductive treatment from donation. Id.

After the 2009 Guidelines were issued, the Congress once
again reenacted Dickey-Wicker as part of the appropriations
bill for fiscal year 2010. The Congress has not enacted an
appropriations bill for FY 2011, adopting instead a series of
continuing resolutions that have carried Dickey-Wicker
forward to the present. Neither party to this case has
suggested the Congress might modify Dickey-Wicker for the
remainder of FY 2011.

Drs. Sherley and Deisher and a number of others filed
this suit in August 2009 and moved the district court for a
preliminary injunction. Instead, the district court granted the
Government’s motion to dismiss the suit for want of standing.
The plaintiffs appealed and we reversed in part, holding the
doctors alone had standing because they competed with ESC
researchers for NIH funding. Sherley I, 610 F.3d at 72–74.

On remand, the district court granted the doctors’ motion
and issued a preliminary injunction providing “that
defendants and their officers, employees, and agents are
enjoined from implementing, applying, or taking any action
whatsoever pursuant to the [2009 Guidelines], or otherwise
funding research involving human embryonic stem cells as
contemplated in the Guidelines.” Upon the Government’s
motion, this court stayed the preliminary injunction pending
appeal thereof. In the meantime, proceedings have continued
in the district court, where the parties have cross-moved for
summary judgment. The only question before us now,
therefore, is the propriety of the preliminary injunction.
 8

II. Analysis

A preliminary injunction is “an extraordinary remedy that
may only be awarded upon a clear showing that the plaintiff is
entitled to such relief.” Winter v. Natural Res. Def. Council,
Inc., 129 S. Ct. 365, 376 (2008). “A plaintiff seeking a
preliminary injunction must establish [1] that he is likely to
succeed on the merits, [2] that he is likely to suffer irreparable
harm in the absence of preliminary relief, [3] that the balance
of equities tips in his favor, and [4] that an injunction is in the
public interest.” Id. at 374.

We pause to consider how we are to treat these four
factors. Before Winter, this court and others had allowed that
a strong showing on one factor could make up for a weaker
showing on another. See Davenport v. Int’l Bhd. of
Teamsters, 166 F.3d 356, 360–61 (D.C. Cir. 1999); see also
Winter, 129 S. Ct. at 392 (Ginsburg, J., dissenting) (“courts
have evaluated claims for equitable relief on a ‘sliding scale,’
sometimes awarding relief based on a lower likelihood of
harm when the likelihood of success is very high”). In Davis
v. Pension Benefit Guaranty Corp., 571 F.3d 1288, 1292
(2009), we noted that Winter “could be read to create a more
demanding burden” than the sliding-scale analysis requires
although, as we there observed, Justice Ginsburg does not
think so, see Winter, 129 S. Ct. at 392. In Davis, however, we
did not have to resolve the issue because we would have
reached the same conclusion under either approach. 571 F.3d
at 1292.

In their concurring opinion in Davis, two judges
expressed the view that “under the Supreme Court's
precedents, a movant cannot obtain a preliminary injunction
without showing both a likelihood of success and a likelihood
 9
of irreparable harm, among other things.” Id. at 1296. They
noted that the Winter Court seemed to treat the four factors as
independent requirements and specifically to reject the Ninth
Circuit’s statement that a strong likelihood of success on the
merits lessens the movant’s burden to showing merely a
“possibility” rather than a “likelihood” of irreparable harm.
Id. (citing Winter, 129 S. Ct. at 374-76); see also Nken v.
Holder, 129 S. Ct. 1749, 1763 (2009) (Kennedy, J.,
concurring) (“When considering success on the merits and
irreparable harm, courts cannot dispense with the required
showing of one simply because there is a strong likelihood of
the other”).

Like our colleagues, we read Winter at least to suggest if
not to hold “that a likelihood of success is an independent,
free-standing requirement for a preliminary injunction,”
Davis, 571 F.3d at 1296 (concurring opinion). Although the
Fourth Circuit has read the same case to similar effect, see
Real Truth About Obama, Inc. v. FEC, 575 F.3d 342, 347
(2009), other circuits do not understand it to preclude
continuing adherence to the sliding-scale approach, see
Alliance for the Wild Rockies v. Cottrell, No. 09-35756, 2011
WL 208360, at *3–7 (9th Cir. Jan. 25, 2011); Citigroup
Global Mkts., Inc. v. VCG Special Opportunities Master Fund
Ltd., 598 F.3d 30, 35–38 (2d Cir. 2010); Hoosier Energy
Rural Elec. Coop. v. John Hancock Life Ins. Co., 582 F.3d
721, 725 (7th Cir. 2009). We need not wade into this circuit
split today because, as in Davis, as detailed below, in this case
a preliminary injunction is not appropriate even under the less
demanding sliding-scale analysis.

We review the district court’s balancing of the four
factors for abuse of discretion. Davis, 571 F.3d at 1291.
Insofar as the inquiry depends upon a question of law, our
review is, of course, de novo. Id.; Ark. Dairy Coop. Ass’n v.
 10
USDA, 573 F.3d 815, 821 (D.C. Cir. 2009). In this case, our
de novo review is central to the plaintiffs’ likelihood of
success on the merits, see City of Las Vegas v. Lujan, 891
F.2d 927, 931–32 (D.C. Cir. 1989), which success depends
upon an issue of statutory interpretation.

A. Likelihood of Success on the Merits

In entering the preliminary injunction, the district court
concluded the plaintiff doctors are likely to succeed in
demonstrating the 2009 Guidelines are inconsistent with the
limits upon funding in the Dickey-Wicker Amendment. 704
F. Supp. 2d 63, 70–72 (2010). We approach this issue under
the familiar two-step framework of Chevron U.S.A., Inc. v.
Natural Resources Defense Council, Inc., 467 U.S. 837, 842–
43 (1984): If the Congress has “directly spoken to the precise
question at issue,” then we must “give effect to the
unambiguously expressed intent of Congress”; if instead the
“statute is silent or ambiguous with respect to the specific
issue,” then we defer to the administering agency’s
interpretation as long as it reflects “a permissible construction
of the statute.”

1. Chevron step one

We begin our review, of course, by looking to the text
of Dickey-Wicker, which bars federal funding specifically for
“research in which a human embryo or embryos are
destroyed, discarded, or knowingly subjected to risk of injury
or death greater than that allowed for research on fetuses in
utero” under the Public Health Service Act and a particular
regulation of the Department of Health and Human Services.
The district court held, and the plaintiffs argue on appeal, this
provision unambiguously bars funding for any project using
an ESC. They reason that, because an embryo had to be
 11
destroyed in order to yield an ESC, any later research project
that uses an ESC is necessarily “research” in which the
embryo is destroyed. For its part, the Government argues the
“text is in no way an unambiguous ban on research using
embryonic stem cells” because Dickey-Wicker is written in
the present tense, addressing research “in which” embryos
“are” destroyed, not research “for which” embryos “were
destroyed.”

The use of the present tense in a statute strongly suggests
it does not extend to past actions. The Dictionary Act
provides “unless the context indicates otherwise ... words
used in the present tense include the future as well as the
present.” 1 U.S.C. § 1. As the Supreme Court has observed,
that provision implies “the present tense generally does not
include the past.” Carr v. United States, 130 S. Ct. 2229,
2236 (2010). The context here does not, as our dissenting
colleague would have it, indicate a different understanding.
To the contrary, as amicus the University of California urges
in its brief, and as the Government emphasized at oral
argument, NIH funding decisions are forward-looking,
requiring the NIH to “determine whether what is proposed to
be funded meets with its requirements.” Therefore, a grant
application to support research that includes the derivation of
stem cells would have to be rejected. *

*
The plaintiffs urge us to adopt the district court’s view that
Dickey-Wicker incorporates the definition of “research” in the
Human Subject Protection regulations: “a systematic investigation,
including research development, testing and evaluation, designed to
develop or contribute to generalizable knowledge.” 45 C.F.R. §
46.102(d). The Government argues otherwise, but we need not
resolve this debate because, as the Government also argues, that a
project involves “research development” or is “‘systematic’ does
not mean that it includes acts or processes,” such as deriving ESCs,
“that predated the federally funded research.”
 12
The plaintiffs respond by reiterating their primary
argument: Because “research” using an ESC includes
derivation of the ESC, the derivation does not predate but is
an integral part of the “research.” The conclusion does not
follow from the premise; at best it shows Dickey-Wicker is
open to more than one possible reading. * The plaintiffs also
argue we must read the term “research” broadly because the
Congress, had it intended a narrower reading, would have
used a term identifying a particular action, as it did in
subsection (1) of Dickey-Wicker, which specifically bars the
“creation” of an embryo for “research purposes.” We see no
basis for that inference. The definition of research is flexible
enough to describe either a discrete project or an extended
process, but this flexibility only reinforces our conclusion that
the text is ambiguous.

2. Chevron step two

We turn, therefore, to Chevron step two, under which we
must uphold the NIH’s interpretation of Dickey-Wicker if it is
but “reasonable.” See Chevron, 467 U.S. at 844. Recall the
relevant text is the prohibition against funding for “research in
which a human embryo or embryos are destroyed.” The NIH
determined Dickey-Wicker does not bar its funding a project
using an ESC that was previously derived because a stem cell

*
The plaintiffs rely upon Merck KGaA v. Integra Lifesciences I,
Ltd., 545 U.S. 193, 202 (2005), but that case is inapposite; it
involved a statute that protected from an infringement claim the use
of patented materials “reasonably related to the development and
submission of information” to the FDA in a regulatory proceeding.
Although the Court concluded the statute protected the use of
patented materials at all phases of research, the ruling did not
depend upon an interpretation of the term “research,” and does not
bear upon our understanding of “research” in Dickey-Wicker. See
id. at 202.
 13
is not an “embryo” and cannot develop into a human being.
The plaintiffs do not dispute this much of the agency’s
reasoning.

The plaintiffs argue instead the NIH is not entitled to
deference because it never offered an interpretation of the
term “research.” Their premise is not entirely correct: In the
2009 Guidelines the NIH expressly distinguished between the
derivation of ESCs and “research involving [ESCs] that does
not involve an embryo nor result in an embryo’s destruction.”
74 Fed. Reg. 32,173/2. Thus, although the Guidelines do not
define the term “research,” they do make clear the agency’s
understanding that “research involving [ESCs]” does not
necessarily include the antecedent process of deriving the
cells.

The plaintiffs, invoking our opinion in Public Citizen,
Inc. v. HHS, 332 F.3d 654, 661 (2003), argue the agency’s
effort in this respect is insufficiently specific to warrant our
deference. In the cited case we did not defer to HHS because
the agency had not actually addressed the disputed portion of
the statute; indeed, it had “[done] little more than repeat the
statutory language” and had failed to offer any explanation for
its position that a Peer Review Organization could “inform” a
Medicare beneficiary of its disposition of his complaint about
a treating physician with a form letter lacking most of the
pertinent information. Id. There was, in short, “no reasoning
that we [could] evaluate for its reasonableness.” Id. Here, in
contrast, the NIH has explained how funding an ESC project
is consistent with the Dickey-Wicker Amendment. The
plaintiffs’ objection that the NIH has not explicitly defined a
word in the statute — an important word, to be sure — is
mere cavil; it disregards the agency’s use of the term, which
implicitly but unequivocally gives “research” a narrow scope,
thus ensuring no federal funding will go to a research project
 14
in which an embryo is destroyed. See Nat’l R.R. Passenger
Corp. v. Boston & Maine Corp., 503 U.S. 407, 420 (1992)
(that agency’s “interpretation of the word ‘required’” was
implicit “does not mean that we may not defer to that
interpretation”).

To this point the plaintiffs apparently respond that the
NIH has, by treating derivation as part of “research,” shown
its understanding of Dickey-Wicker is unreasonable. Their
argument is that, because the standard definition of “research”
requires some kind of scientific inquiry, and deriving ESCs,
standing alone, involves no such inquiry, the act of derivation
can be deemed “research” only if it is part of a larger project.
The plaintiffs refer us to 45 C.F.R. § 46.102(d), supra at 11
n.*; see also, e.g., MERRIAM-WEBSTER DICTIONARY ONLINE,
http://merriam-webster.com/dictionary/research (last visited
Mar. 20, 2011) (“careful or diligent search”; “studious inquiry
or examination; especially: investigation or experimentation
aimed at the discovery and interpretation of facts, revision of
accepted theories or laws in the light of new facts, or practical
application of such new or revised theories or laws”);
OXFORD ENGLISH DICTIONARY ONLINE,
http://www.oed.com/viewdictionaryentry/Entry/163432 (last
visited Mar. 22, 2011) (“Systematic investigation or inquiry
aimed at contributing to knowledge of a theory, topic, etc., by
careful consideration, observation, or study of a subject”).
The plaintiffs’ premise is valid in part: Because the
Guidelines state Dickey-Wicker bans funding for the
derivation of ESCs and Dickey-Wicker bans only “research,”
it is clear the NIH treats the act of derivation as “research.”
The Government expressly confirmed this much at oral
argument when counsel flatly stated “derivation is research.”
Less clear is whether the act of derivation, by itself, comes
within a standard definition of research, that is, whether it
involves any investigation or inquiry. On that score, the
 15
Government pointed out at oral argument that “stem cells are
not pre-labeled cells that you can simply extract,” and argued
“the scientific process” of derivation, in which cells are
“extracted and put into mediums where [they] can grow”
before being examined and chemically treated, “itself
involves experimentation.”

Rather than rely upon that account of derivation
qualifying as research, let us assume for the sake of the
plaintiffs’ argument derivation involves no scientific inquiry;
it does not follow that the NIH may define derivation as
“research” only if or insofar as the derivation is tethered to
some later project using the derived cells. Although an
understanding of “research” that includes the derivation of
stem cells is not the ordinary reading of that term, it is surely
as sensible as the plaintiffs’ alternative, in which the
derivation of a cell line is deemed part of every one of the
scores if not hundreds of subsequent research projects —
although pursued by different scientists, perhaps many years
later — to use one of the derived cells. To define derivation
as “research,” in other words, makes at least as much sense as
to treat the one-off act of derivation as though it had been
performed anew each time a researcher, however remote in
time or place, uses a stem cell from the resulting line. * The
fact is the statute is not worded precisely enough to resolve
the present definitional contest conclusively for one side or
the other.

Broadening our focus slightly, however, we can see the
words surrounding “research” in the statute support the NIH’s
*
Our dissenting colleague takes us to task for “read[ing] ‘research’
as if it were synonymous with ‘research project,’” but we give it no
such fixed meaning. Rather, our point is that “research,” although
susceptible to a broad definition, is also reasonably understood as a
more discrete endeavor.
 16
reading. Because the Congress wrote with particularity and in
the present tense — the statute says “in which” and “are”
rather than “for which” and “were” — it is entirely reasonable
for the NIH to understand Dickey-Wicker as permitting
funding for research using cell lines derived without federal
funding, even as it bars funding for the derivation of
additional lines.

Further, adding the temporal dimension to our
perspective, we see, as the NIH noted in promulgating the
2009 Guidelines, the Congress has reenacted Dickey-Wicker
unchanged year after year “with full knowledge that HHS has
been funding [ESC] research since 2001,” 74 Fed. Reg.
32,173/2, when President Bush first permitted federal funding
for ESC projects, provided they used previously derived ESC
lines. As the plaintiffs conceded at oral argument, because
this policy permitted the NIH to fund projects using ESCs, it
would have been prohibited under their proposed reading of
Dickey-Wicker. So, too, with the policy the Clinton
Administration announced in 1999 and, of course, with the
2009 Guidelines promulgated by the Obama Administration.
The plaintiffs have no snappy response to the agency’s point
that the Congress’s having reenacted Dickey-Wicker each and
every year provides “further evidence ... [it] intended the
Agency’s interpretation, or at least understood the
interpretation as statutorily permissible.” Barnhart v. Walton,
535 U.S. 212, 220 (2002); accord Lindahl v. OPM, 470 U.S.
768, 782 n.15 (1985) (“Congress is presumed to be aware of
an administrative or judicial interpretation of a statute and to
adopt that interpretation when it reenacts a statute without
change” (internal quotation marks omitted)). *

*
The parties’ disagreement over whether the NIH’s interpretation
should be deemed “longstanding” is beside the point; this is not a
situation in which we are asked to infer the Congress’s assent from
 17

3. Subsidiary Arguments

A few matters remain. First, we note, because the
plaintiffs bring solely a facial challenge to the Guidelines, we
have no occasion to consider their suggestion that the NIH
might grant the researcher who derived an ESC line federal
funds for research using it, which would link the act of
derivation more closely to subsequent research and test the
distinction between them drawn by the NIH. However that
case — were it ever to materialize — might play out is
irrelevant here. * To prevail in their challenge to the
Guidelines on their face the plaintiffs “must establish that no
set of circumstances exists under which the [Guidelines]
would be valid,” Reno v. Flores, 507 U.S. 292, 301 (1993)
(internal quotation marks omitted); it is not enough for the
plaintiffs to show the Guidelines could be applied unlawfully,
see Air Transp. Ass’n of Am. v. DOT, 613 F.3d 206, 213 (D.C.
Cir. 2010); see also Am. Hosp. Ass’n v. NLRB, 499 U.S. 606,
619 (1991) (“that petitioner can point to a hypothetical case in
which the rule might lead to an arbitrary result does not
render the rule ‘arbitrary or capricious’”). **

its inaction over a long period. Regardless how much time has
passed, reenactment is evidence the Congress approves the
agency’s application of the statute. Creekstone Farms Premium
Beef L.L.C. v. USDA, 539 F.3d 492, 500–501 & n.10 (D.C. Cir.
2008).
*
The same is true of the plaintiffs’ suggestion that a researcher
might use federal funds to purchase ESCs; it is nothing more than
another argument that the Guidelines could be applied unlawfully.
**
As the dissent notes, a panel of this court once held this standard
inapplicable to a facial statutory (as opposed to a facial
constitutional) challenge to a regulation. See Nat’l Mining Ass’n v.
U.S. Corps. of Eng’rs, 145 F.3d 1399, 1407-08 (D.C. Cir. 1998).
That decision, however, was made in the mistaken belief that the
 18

The plaintiffs also argue the Guidelines transgress the
prohibition in Dickey-Wicker against “research in which a
human embryo or embryos are ... knowingly subjected to risk
of injury or death.” To the extent this argument is distinct
from the plaintiffs’ principal argument that all ESC research
is research in which an embryo is destroyed, it relies upon the
proposition that ESC research “creat[es] demand for[] human
embryonic stem cells,” which “necessitate[s] the destruction
of embryos.” The district court did not address this theory in
entering the preliminary injunction. Although ordinarily we
“may affirm the judgment of the district court on the basis of
a different legal theory,” Harbor Ins. Co. v. Stokes, 45 F.3d
499, 501 (D.C. Cir. 1995) (summary judgment), the decision
whether to grant a preliminary injunction is a matter of
discretion, not a question of right, see Winter, 129 S. Ct. at
376–77. Not surprisingly, therefore, the plaintiffs have not
identified, nor have we found, any precedent for upholding a
preliminary injunction based upon a legal theory not
embraced by the district court. In this as in every such case, it
is for the district court to determine, in the first instance,
whether the plaintiffs’ showing on a particular claim warrants
preliminary injunctive relief. For the same reason we do not

“Supreme Court ha[d] never adopted a ‘no set of circumstances’
test to assess the validity of a regulation challenged as facially
incompatible with governing statutory law.” Id. at 1407. The
Court had done just that several years earlier in Flores. Although
Flores is not literally, therefore, an “intervening” decision of the
Supreme Court, see Amfac Resorts, L.L.C. v. DOI, 282 F.3d 818,
827 (D.C. Cir. 2002), vacated as not ripe sub nom. Nat’l Park
Hospitality Ass’n v. DOI, 538 U.S. 803 (2003), we have followed it
since National Mining, see, e.g., Air Transp. Ass’n, 613 F.3d at
213; Bldg. & Constr. Trades Dep't v. Allbaugh, 295 F.3d 28, 33
(2002), and, bound as we are by a higher authority, do so again
here.
 19
pass upon the plaintiffs’ argument they are likely to succeed
on their claim under the Administrative Procedure Act that
the NIH promulgated the Guidelines “through an inadequate
notice-and-comment process.”

Because those of the plaintiffs’ legal arguments that are
properly before us do not stand up well to analysis, it follows
they have not shown they are more likely than not to succeed
on the merits of their case. Indeed, were we to adopt the strict
reading given Winter by our concurring colleagues in Davis,
our inquiry would end here. Under the sliding-scale
approach, however, we must go on to determine whether the
other three factors so much favor the plaintiffs that they need
only have raised a “serious legal question” on the merits. See
Wash. Area Transit Comm’n v. Holiday Tours, Inc., 559 F.2d
841, 843–44 (D.C. Cir. 1977) (“a court, when confronted with
a case in which the other three factors strongly favor interim
relief may exercise its discretion to grant a stay if the movant
has made a substantial case on the merits”). That much the
plaintiffs have done. We turn therefore to another of the four
factors, whether “the balance of equities tips in [the
plaintiffs’] favor,” Winter, 555 U.S. at 374. Because it does
not, we need not consider either of the other two factors.

B. Balance of the Equities

The district court reasoned the “balance of hardships
weighs in favor of an injunction” because, for ESC
researchers, “the injunction would simply preserve the status
quo and would not interfere with their ability to obtain private
funding.” 704 F. Supp. 2d at 72. On the other hand, the court
thought it certain that increased competition would “threaten
[the plaintiffs’] very livelihood.” Id. at 72–73.
 20
As we see it, however, a preliminary injunction would in
fact upend the status quo. True, the plaintiffs compete with
ESC researchers for funding — indeed, that is why they have
standing to bring this case, see Sherley I, 610 F.3d at 71–74
— but they have been competing with ESC researchers since
2001. The 2009 Guidelines inflict some incremental handicap
upon the plaintiffs’ ability to compete for NIH money — they
point to the additional time and money they must expend and
have had to expend since 2001 to meet the additional
competition from researchers proposing to use ESCs — but it
is necessarily uncertain whether invalidating the Guidelines
would result in the plaintiffs getting any more grant money
from the NIH. Accordingly, we cannot say that, if the
plaintiffs are to litigate this case without the benefit of interim
relief, then the 2009 Guidelines will place a significant
additional burden upon their ability to secure funding for their
research.

The hardship a preliminary injunction would impose
upon ESC researchers, by contrast, would be certain and
substantial. The injunction entered by the district court would
preclude the NIH from funding new ESC projects it has or
would have deemed meritorious, thereby inevitably denying
other scientists funds they would have received. Even more
problematic, the injunction would bar further disbursements
to ESC researchers who have already begun multi-year
projects in reliance upon a grant from the NIH; their
investments in project planning would be a loss, their
expenditures for equipment a waste, and their staffs out of a
job. The record shows private funding is not generally
available for stem cell research but even if, as the district
court thought, private donors or investors would provide a
reasonable alternative source of funds for ESC researchers,
704 F. Supp. 2d at 72, it remains unclear why such donors or
investors would not similarly support the plaintiffs’ research
 21
using adult stem cells and why the plaintiffs’ “very
livelihood” instead depends upon obtaining grants from the
NIH.

All this is to say the balance of equities tilts against
granting a preliminary injunction. That, combined with our
conclusion the plaintiffs have not shown they are likely to
succeed on the merits, leads us to hold the district court
abused its discretion in awarding preliminary injunctive relief.

III. Conclusion

Because the plaintiffs have not shown they are likely to
succeed on the merits, we conclude they are not entitled to
preliminary injunctive relief. We reach this conclusion under
the sliding scale approach to the preliminary injunction
factors; a fortiori we would reach the same conclusion if
likelihood of success on the merits is an independent
requirement. Therefore, the preliminary injunction entered by
the district court must be and is
Vacated.
KAREN LECRAFT HENDERSON , Circuit Judge, dissenting:
The majority opinion has taken a straightforward case of
statutory construction and produced a result that would make
Rube Goldberg tip his hat. Breaking the simple noun “research”
into “temporal” bits, Maj. Op. at 5, 6, 16, narrowing the verb
phrase “are destroyed” to an unintended scope, id. at 11,
dismissing the definition section of implementing regulations
promulgated by the Department of Health and Human Services
(HHS) (in case the plain meaning of “research” were not plain
enough), id. at 11 n.*, my colleagues perform linguistic jujitsu.
I must therefore respectfully dissent.
The Government appeals from the district court’s entry of
a preliminary injunction prohibiting it “from implementing,
applying, or taking any action whatsoever pursuant to” the NIH
Guidelines for Human Stem Cell Research (Guidelines), 32 Fed.
Reg. 32,170 (July 7, 2009), “or otherwise funding research
involving human embryonic stem cells as contemplated in the
Guidelines.” Order, Sherley v. Sebelius, 704 F. Supp. 2d 63
(D.D.C. Aug. 23, 2010) (No. 09-1575). “On a motion for a
preliminary injunction, the district court must balance four
factors: (1) the movant’s showing of a substantial likelihood of
success on the merits, (2) irreparable harm to the movant, (3)
substantial harm to the nonmovant, and (4) public interest.”
Davis v. Pension Benefit Guar. Corp., 571 F.3d 1288, 1291
(D.C. Cir. 2009). We review the district court’s weighing of the
preliminary injunction factors for abuse of discretion and its
findings of fact under the clearly erroneous standard. Id. To the
extent its decision turns on a question of law, our review is de
novo. Id. I believe that the plaintiffs, researchers who use adult
stem cells only, are likely to succeed on the merits of their
challenge to the Guidelines and that the district court did not
abuse its discretion in weighing the preliminary injunction
factors in favor of granting the injunction. Accordingly, I would
affirm.
 I. Likelihood of Success on the Merits
The majority opinion sets out the background information
describing the “derivation” of human embryonic stem cells
(hESCs) from a human embryo—which action destroys the
embryo—and the subsequent use of the hESCs in the hope of
remedying many serious, and often fatal, diseases and
debilitating physical conditions. I take no exception to that
portion of the majority opinion except to the extent that it recites
the “historical record suggests the Congress passed the [Dickey-
Wicker] Amendment chiefly” to address matters other than
hESC research. Maj. Op. at 4. The Government’s brief suggests
otherwise. After explaining that the Congress enacted the
Amendment “in reaction to a 1994 NIH panel report,”
Appellants’ Br. 21, it recites that the 1994 report advocated
federal funding of research “designed to improve the process of
in vitro fertilization, to determine whether embryos carried
genetic abnormalities, and to isolate embryonic stem cells.” Id.
(second emphasis added). There is no reason to assume,
therefore, the Congress did not consider hESC research when it
first enacted the Dickey-Wicker Amendment (Amendment) in
1996.
The Amendment, reenacted annually as a rider to
appropriations legislation, prohibits the expenditure of federal
funds both for “the creation of a human embryo or embryos for
research purposes” and for “research in which a human embryo
or embryos are destroyed.” Consolidated Appropriations Act of
2010, Pub. L. No. 111-117, § 509(a), 123 Stat. 3034, 3280-81
(Dec. 16, 2009). It is the latter ban that the plaintiffs claim is
violated by the 2009 Guidelines. Determining whether hESC
research is “research in which a human embryo or embryos are
destroyed” requires determining the meaning of “research.” The
plaintiffs contend that all hESC research constitutes research in
which human embryos are destroyed and that the Amendment

2
accordingly prohibits federal funding thereof. The Government
counters that the derivation of hESCs and the subsequent use of
those cells, although both research, are not part of the
same—and prohibited—research. We construe the Amendment
under the familiar two-step approach set forth in Chevron U.S.A.
Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837, 842-43
(1984). Chevron step one asks if the “Congress has directly
spoken to the precise question at issue.” Id. at 842. “We start
with the plain meaning of the text, looking to the language itself,
the specific context in which that language is used, and the
broader context of the statute as a whole.” Blackman v. District
of Columbia, 456 F.3d 167, 176 (D.C. Cir. 2006) (internal
quotation marks omitted). I believe we need go no further than
Chevron step one here because the plain meaning of the
Amendment is easily grasped. See id. (“If the [statute] has a
plain and unambiguous meaning, our inquiry ends so long as the
resulting statutory scheme is coherent and consistent.” (internal
quotation marks omitted)). Accordingly, “that is the end of the
matter; for the court, as well as the agency, must give effect to
the unambiguously expressed intent of Congress.” Chevron, 467
U.S. at 842-43.
The district court correctly looked to the dictionary
definition of “research” as “diligent and systematic inquiry or
investigation into a subject in order to discover or revise facts,
theories, applications, etc.” Sherley v. Sebelius, 704 F. Supp. 2d
at 70 (citing Random House Dictionary); see also Maj. Op. at 14
(quoting Oxford English Dictionary Online (“Systematic
investigation or inquiry aimed at contributing to knowledge of
a theory, topic, etc., by careful consideration, observation, or
study of a subject”)). Research, then, comprises a systematic
inquiry or investigation. And “systematic” connotes sequenced
action. XVII Oxford English Dictionary 498 (2d ed. 1989)
(“systematic”: “Arranged or conducted according to a system,
plan, or organized method . . . .”); see also CACI Int’l, Inc. v. St.

3
Paul Fire & Marine Ins. Co., 566 F.3d 150, 158-59 (4th Cir.
2009) (describing “systematic” behavior as “a series of acts”
(internal quotation marks omitted)). The first sequence of hESC
research is the derivation of stem cells from the human embryo.
The derivation of stem cells destroys the embryo and therefore
cannot be federally funded, as the Government concedes. See
Maj. Op. at 14-15. I believe the succeeding sequences of hESC
research are likewise banned by the Amendment because, under
the plain meaning of “research,” they continue the “systematic
inquiry or investigation.”
That the intent of the 1996 Congress, in enacting the
Amendment, is to prohibit all hESC research—not just research
attendant on the derivation of the cells—is clear by comparing
the language used to ban federal funding for the creation of an
embryo with the language the plaintiffs rely on. See Erlenbaugh
v. United States, 409 U.S. 239, 244 (1972) (rule that statutes in
pari materia should be construed together “is but a logical
extension of the principle that individual sections of a single
statute should be construed together”); Motion Picture Ass’n of
Am. v. FCC, 309 F.3d 796, 801 (D.C. Cir. 2002) (“Statutory
provisions in pari materia normally are construed together to
discern their meaning.”). While the Amendment prohibits
federal financing of the “creation of a human embryo . . . for
research purposes,” it does not use parallel language in
addressing the destruction of embryos. It bans federal funding
of “research” rather than the “destruction of human embryos for
research purposes.” Research, then, is the express target of the
ban the Congress imposed with respect to the destruction of a
human embryo. This makes perfect sense because in 1996,
according to the record, hESC research had barely begun.
Deisher Decl. ¶ 7. The Congress, recognizing its scant
knowledge about the feasibility/scope of hESC research, chose
broad language with the plain intent to make the ban as complete
as possible. Because the meaning of research is plain, and the

4
intent of the Congress to ban the federal funding of hESC
research is equally plain, I would stop at Chevron step one and
enjoin the Guidelines as violative of the Amendment to the
extent they allow federal funds to be used for hESC research.
If there were any uncertainty about the extent of the
Amendment’s ban, it would be erased by reading the
Amendment’s language in full, as the district court—again,
correctly—did. The ban on federal funding of hESC research
provides that federal funds may not be used for:
[R]esearch in which a human embryo or embryos are
destroyed, discarded, or knowingly subjected to risk of
injury or death greater than that allowed for research on
fetuses in utero under 45 CFR 46.204(b) and section
498(b) of the Public Health Service Act (42 U.S.C.
289g(b)).
Pub. L. No. 111-117, § 509(a)(2), 123 Stat. at 3280-81. The
Amendment’s incorporation of 45 C.F.R. § 46.204(b)—HHS’s
own regulation—relates to “[r]esearch involving pregnant
women and fetuses,” as section 46.204 is entitled. “Research,”
as used in section 46.204(b), means “a systematic investigation,
including research development, testing and evaluation,
designed to develop or contribute to generalizable knowledge.”
45 C.F.R. § 46.102(d) (emphasis added); see id. § 46.202
(“definitions in § 46.102 [are] applicable to [§ 46.204]”). In
expressly linking “research in which a human embryo or
embryos are destroyed, discarded, or knowingly subjected to risk
of injury or death” and “research on fetuses in utero under 45
CFR 46.204(b),” the Congress unambiguously manifested its
intent that “research” as used in the Amendment is to have the

5
same meaning as “research” used in section 46.204(b).1
Moreover, the “presumption that a given term is used to mean
the same thing throughout a statute” is “at its most vigorous
when a term is repeated within a given sentence,” as “research”
is in the Amendment. Brown v. Gardner, 513 U.S. 115, 118
(1994). Section 46.102(d) confirms that research involves
sequenced action by defining it to include “development, testing
and evaluation” sequences. “Research development” perfectly
describes the first sequence of hESC research, that is, the
derivation of the cells. The testing and evaluation sequences of
hESC research cannot be performed without first conducting the
research involved in deriving hESCs from the human embryo.
The derivation of hESCs is, thus, the sine qua non
developmental sequence on which all subsequent sequences of
hESC research rest. Moreover, nothing in the record suggests
that hESCs are derived for any purpose other than the testing and
evaluation of those cells. That hESCs cannot be tested and
evaluated unless and until they are derived from a human
embryo, combined with the fact that derivation of hESCs is done
solely as part of a “systematic investigation” of those cells,
demonstrates that derivation is the necessary first sequence of
hESC research. Because derivation of hESCs necessarily
destroys a human embryo or embryos, and because derivation
constitutes at least hESC research development under the
Amendment, all hESC research is “research in which a human
embryo or embryos are destroyed.” Accordingly, the plaintiffs’
challenge to the Amendment is likely to succeed because the

1
That the Amendment references section 46.204(b) in comparing
the risk of injury or death to a human embryo does not affect the
Amendment’s incorporation of section 46.102(d)’s definition of
research. Determining the level of risk permitted for “research on
fetuses in utero under [section] 46.204(b)” necessarily requires
construing “research” and section 46.102(d) defines “research.”

6
Amendment prohibits the expenditure of federal funds to engage
in hESC research in all of its sequences.
In my view, the majority opinion strains mightily to find the
ambiguity the Government presses.2 Treating “research” as
composed of free-standing pieces, it concludes that the only
piece that is banned is the derivation of the hESCs. The
authority for this novel reading of “research” is not the
dictionary but the Amendment’s use of the phrase “in which a
human embryo or embryos are destroyed” rather than “for which
a human embryo or embryos were destroyed.” Maj. Op. at 11
(emphases added).3 The majority opinion correctly notes that the
Dictionary Act, which provides that “unless the context indicates
otherwise . . . words used in the present tense include the future
as well as the present,” 1 U.S.C. § 1, implies “that the present
tense generally does not include the past,” Carr v. United States,
130 S. Ct. 2229, 2236 (2010). That is not true, however, where,
as here, “the context indicates otherwise.” 1 U.S.C. § 1. See
Lindh v. Murphy, 521 U.S. 320, 331 (1997) (“one has to strain
to find . . . ambiguity” in reading statutory provision that “is

2
The Government may not have always taken this view of the
Amendment. See Letter from Kate Berg, Deputy Scientific Director,
NCHGR, to Wendy Fibison, Researcher at Georgetown University
Medical Center (Oct. 10, 1996) (Joint Appendix 283) (“NIH position
on embryo research” is federally funded researchers “[can]not engage
in embryo related research” including certain types of “analysis from
DNA derived from a human embryo”). But see Appellants’ Reply Br.
7-8 (claiming Georgetown research, like derivation, “require[d] the
removal of a cell from an embryo”).
3
The Government’s suggested change in inflection can fairly be
described as Clintonesque (“It depends upon what the meaning of the
word ‘is’ is.” H.R. Rep. No. 105-830, at 40 (Dec. 16, 1998) (quoting
Grand Jury Testimony of President W.J. Clinton, Jones v. Clinton,
No. 94-0290 (E.D. Ark. Apr. 12, 1999), at 57-58 (Aug. 17, 1998))).

7
applicable if a State establishes . . . a mechanism” to include
State that established mechanism before statute’s enactment
(first emphasis added)); Abercrombie v. Clarke, 920 F.2d 1351,
1359 (7th Cir. 1990) (finding “abundantly clear that Congress
intended the present tense language [in provisions of Financial
Institutions Reform, Recovery, and Enforcement Act of 1989
providing for civil monetary penalties] to apply to past acts”),
cert. denied, 502 U.S. 809 (1991); Bell v. Maryland, 378 U.S.
226, 236 (1964) (“very possibl[e]” that Maryland Court of
Appeals would hold “the use of the present tense instead of the
more usual future tense” in Maryland statute “to apply to past as
well as future conduct”); Coal. for Clean Air v. S. Cal. Edison
Co., 971 F.2d 219, 225 (9th Cir. 1992) (“The present tense is
commonly used to refer to past, present, and future all at the
same time. We believe that Congress used the present tense
word . . . because it did not wish to limit [the statute’s] reach to
either past or future disapprovals.”); United States v. Reilly Tar
& Chem. Corp., 546 F. Supp. 1100, 1108-09 (D. Minn. 1982)
(provision allowing United States to seek injunction against any
person “contributing to” handling, storage, treatment,
transportation or disposal of solid or hazardous waste could be
applied, at motion to dismiss stage, to past owner of inactive site
who was no longer “contributing to the condition”); cf. Carr,
130 S. Ct. at 2244-45 (Alito, J., dissenting) (responding to
majority’s reliance on statute’s use of present tense to reject
statute’s reach to past tense by noting that “modern legislative
drafting manuals,” including those used by both the United
States Senate and House, “teach that, except in unusual
circumstances, all laws . . . should be written in the present
tense”); Nickell v. Beau View of Biloxi, LLC, No. 10-60204, —
F.3d —, 2011 WL 1120792, at *4-5 (5th Cir. Mar. 28, 2011)
(notwithstanding general rule, context indicated otherwise where
inclusion of future events would conflict with statute of
limitations and other time-limited rights conferred by statute);

8
see also Guidiville Band of Pomo Indians v. NGV Gaming, Ltd.,
531 F.3d 767, 776 (9th Cir. 2008) (“[O]n its own terms the
Dictionary Act . . . looks first to ‘context,’ and only if the
‘context’ leaves the meaning open to interpretation does the
default provision come into play.”). There is no question that,
here, context manifests that the present tense includes both the
past as well as the future.4 As already discussed, the derivation
of hESCs constitutes at least research development, which, in
context, means that it is “research in which a human embryo or
embryos are [at any point] destroyed.”
But it is not only the majority opinion’s view of verb tenses
that is wrong. My colleagues rest their Chevron step two
analysis on the transformation of “research” into “research
project” in the Amendment’s text. In other words, it reads
“research” as if it were synonymous with “research project.”
Maj. Op. at 2-5, 10-16, 20. But “research” is the overall
“systematic investigation or inquiry” in a field—here,
hESCs—of which each project is simply a part. Webster’s Third
New International Dictionary 1813 (1993) (“project” means “a
definitely formulated piece of research” (emphasis added)).

4
Moreover, the Amendment combines the present tense “are”
with the past participle “destroyed,” that is, with “[a] verb form
indicating past or completed action or time that is used as a verbal
adjective.” Fla. Dep’t of Revenue v. Piccadilly Cafeterias, Inc., 554
U.S. 33, 39 (2008) (alteration in original) (quoting American Heritage
Dictionary 1287 (4th ed. 2000)). Other statutes similarly use the
present tense, especially a combination of “is” with a past participle,
to signify conduct that has already occurred. See, e.g., 10 U.S.C.
§ 6253 (Secretary of Navy “may replace . . . any medal of honor,
Navy cross[ etc.] awarded under this chapter that is stolen, lost, or
destroyed or becomes unfit for use” (emphases added), that is, a medal
which has been stolen, lost, or destroyed or become unfit for use
before replacement).

9
Without the majority opinion’s misreading of “research” as
“research project,” the entire notion of pieces of research
evaporates—taking with it the “ambiguity” that sets Chevron
step two in motion.5
Finally, it is of little moment that the Congress has
reenacted the Amendment unchanged every year since 1996.
While congressional reenactment ordinarily means the Congress
intended to adopt an existing agency interpretation of the statute,
e.g., Commodity Futures Trading Comm’n v. Schor, 478 U.S.
833, 846 (1986), “[t]here is an obvious trump to the reenactment
argument . . . in the rule that ‘[w]here the law is plain,
subsequent reenactment does not constitute an adoption of a
previous administrative construction,’ ” Brown v. Gardner, 513
U.S. 115, 121 (1994) (quoting Demarest v. Manspeaker, 498
U.S. 184, 190 (1991)). Moreover, “congressional silence lacks
persuasive significance, particularly where administrative
regulations are inconsistent with the controlling statute,” id.
(internal quotation marks and citations omitted), and “[a]
regulation’s age is no antidote to clear inconsistency with a
statute,” id. at 122.6 Because I believe the Government’s reading
of the Amendment contravenes the Amendment’s plain
meaning, I am unpersuaded that the Congress, by simply
reenacting the Amendment, has sanctioned that reading.7

5
Likewise, the sequenced action inherent in “research,” supra
pp. 3-4, does not equate to individual research “projects.”
6
Moreover, the challenged Guidelines were not promulgated
until 2009 so that congressional reenactment of the Amendment in the
years predating 2009 signifies nothing in relation to the Guidelines.
7
The majority opinion dismisses the plaintiffs’ challenge that the
Guidelines permit a researcher to use federal funds to purchase hESCs
and even permit a federally-funded researcher to derive the cells

10
himself. Maj Op. at 17-18. It concludes those possibilities do not
affect the facial validity of the Guidelines because they do not
demonstrate that “no set of circumstances exists under which the
[Guidelines] would be valid.” United States v. Salerno, 481 U.S. 739,
745 (1987). Whether Salerno’s “no set of circumstances” approach
is properly applied in the absence of a constitutional challenge is not
altogether settled in our Circuit. We have held “that the Salerno
standard does not apply” when assessing “the validity of a regulation
challenged as facially incompatible with governing statutory law.”
Nat’l Mining Ass’n v. U.S. Army Corps of Eng’rs, 145 F.3d 1399,
1407 (D.C. Cir. 1998). In National Mining we “confirm[ed] that the
normal Chevron test” applies and “is not transformed into an even
more lenient ‘no valid applications’ test just because the attack is
facial.” Id.; accord Becker v. FCC, 95 F.3d 75, 78 (D.C. Cir. 1996).
Subsequently, however, we noted that National Mining “apparently
overlooked Reno v. Flores, 507 U.S. 292 (1993).” Amfac Resorts,
LLC v. Dep’t of the Interior, 282 F.3d 818, 826 (D.C. Cir. 2002),
judgment vacated on other ground sub nom. Nat’l Park Hospitality
Ass’n v. Dep’t of Interior, 538 U.S. 803 (2003). In Reno the Supreme
Court seemed to apply Salerno’s “no set of circumstances” test to an
ultra vires challenge to a regulation. 507 U.S. at 300-01. But see id.
at 309-15 (challenge to regulation does not succeed “if the regulation
has a reasonable foundation, that is, if it rationally pursues a purpose
that it is lawful for the [agency] to seek” (internal quotation marks and
citation omitted)). As Amfac discusses, it is not clear whether the
Salerno test applies to a purely statutory challenge or whether the
standard set forth in INS v. National Center for Immigrants’ Rights,
Inc., 502 U.S. 183, 188 (1991)—under which a regulation can be
invalid even if it has some valid applicability—applies. Amfac, 282
F.3d at 827. Amfac acknowledges that it is of course bound by the
decision of an earlier panel unless, inter alia, “an intervening
Supreme Court decision alters the law of the circuit.” 282 F.3d at
827. Reno, however, predates National Mining. Amfac does not
resolve whether, “despite Reno v. Flores, National Mining . . . must
stand as circuit law unless and until the full court overrules it.” 282
F.3d at 827. Cf. Air Transp. Ass’n of Am. v. U.S. Dep’t of Transp.,

11
Accordingly, the plaintiffs have demonstrated to me a strong
likelihood that they will prevail on the merits.
II. Remaining Factors
In addition to likelihood of success on the merits, the
plaintiffs must also show “(2) irreparable harm to [them], (3)
[no] substantial harm to the [Government], and (4) [the] public
interest [is not harmed],” Davis, 571 F.3d at 1291, in order to
obtain injunctive relief.
To demonstrate irreparable harm in the absence of an
injunction, the plaintiffs’ injury “[must be] of such imminence
that there is a clear and present need for equitable relief to
prevent irreparable harm.” Chaplaincy of Full Gospel Churches
v. England, 454 F.3d 290, 297 (D.C. Cir. 2006) (internal
quotation marks omitted). We earlier held that these two
plaintiffs do indeed suffer “an actual, here-and-now injury” from
the Guidelines and that the probability they will “lose funding to
projects involving [h]ESCs” is “substantial enough . . . to deem
the injury to them imminent.” Sherley v. Sebelius, 610 F.3d 69,
74 (D.C. Cir. 2010) (emphasis added). As the district court
noted, moreover, their injury is irreparable because we “cannot
compensate [them] for their lost opportunity to receive funds.”
Sherley, 704 F. Supp. 2d at 72. The majority opinion now

613 F.3d 206, 213 (D.C. Cir. 2010) (applying Reno to facial challenge
of regulation without discussing Amfac or National Mining); Bldg. &
Constr. Trades Dep’t, AFL-CIO v. Allbaugh, 295 F.3d 28, 33 (D.C.
Cir. 2002) (possibility agency could improperly apply executive order
does not establish facial invalidity thereof). See generally Stuart
Buck, Salerno vs. Chevron: What to do About Statutory Challenges,
55 Admin. L. Rev. 427 (2003).

12
dismisses their injury as “necessarily uncertain.” Maj. Op. at 20.
At the same time, my colleagues see no uncertainty in the harm
to the Government if the injunction is affirmed. Id. I agree that
enjoining the Guidelines would disrupt any hESC research
projects that have already received federal funding and therefore
harm the Government. Finally, I believe the district court
correctly determined that enjoining the Guidelines would further
the public interest. See Sherley, 704 F. Supp. 2d at 73 (“ ‘It is in
the public interest for courts to carry out the will of Congress
and for an agency to implement properly the statute it
administers.’ ” (quoting Mylan Pharms., Inc. v. Shalala, 81 F.
Supp. 2d 30, 45 (D.D.C. 2000))). As discussed supra, I believe
the plaintiffs have made a strong showing of likelihood of
success on the merits. Under the sliding scale approach that
remains the law of our Circuit, see Maj. Op. at 8-9, “[i]f the
movant makes an unusually strong showing on one of the
factors, then it does not necessarily have to make as strong a
showing on another factor.” Davis, 571 F.3d at 1291-92.
Having concluded the plaintiffs have indeed made “an unusually
strong showing” on the first factor, I cannot say the district court
abused its discretion in balancing all of the factors in favor of
granting preliminary injunctive relief.
For the foregoing reasons, I respectfully dissent.

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