UNITED STATES OF AMERICA v. H&R BLOCK, INC. et al
Filing
40
MEMORANDUM re 35 MOTION for Preliminary Injunction filed by UNITED STATES OF AMERICA by UNITED STATES OF AMERICA. (Attachments: # 1 Exhibit Exhibit 1, # 2 Exhibit Exhibit 2, # 3 Exhibit Exhibit 12, # 4 Exhibit Exhibit 13, # 5 Exhibit Exhibit 30, # 6 Exhibit Exhibit 37, # 7 Exhibit Exhibit 40, # 8 Exhibit Exhibit 42, # 9 Exhibit Exhibit 43, # 10 Exhibit Exhibit 56, # 11 Exhibit Exhibit 112, # 12 Exhibit Exhibit 114, # 13 Exhibit Exhibit 115, # 14 Exhibit Exhibit 116, # 15 Exhibit Exhibit 123, # 16 Exhibit Exhibit 124, # 17 Exhibit Exhibit 139, # 18 Exhibit Exhibit 157)(Buterman, Lawrence)
Exhibit
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Only the Westlaw citation is currently available.
United States Court of Appeals,
District of Columbia Circuit.
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.
No. 10–5287.
Argued Dec. 6, 2010.
Decided April 29, 2011.
Background: Two scientists brought suit to enjoin the
National Institutes of Health from funding research
using human embryonic stem cells (ESCs) pursuant to
NIH's guidelines. The United States District Court for
the District of Columbia, 686 F.Supp.2d 1, granted
government's motion to dismiss. The Court of Appeals, 610 F.3d 69, reversed in part. On remand, the
District Court, 704 F.Supp.2d 63, granted scientists'
motion for a preliminary injunction. Government
appealed.
Holdings: The Court of Appeals, Ginsburg, Circuit
Judge, held that:
(1) NIH's interpretation of Dickey–Wicker Amendment was entitled to Chevron deference, and
(2) balance of equities tilted against granting preliminary injunction.
212IV(A)1 In General
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147
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212IV(A) Grounds and Proceedings to Procure
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212k147 k. Evidence and Affidavits.
Most Cited Cases
A preliminary injunction is an extraordinary remedy that may only be awarded upon a clear showing
that the plaintiff is entitled to such relief.
[2] Injunction 212
138.1
212 Injunction
212IV Preliminary and Interlocutory Injunctions
212IV(A) Grounds and Proceedings to Procure
212IV(A)2 Grounds and Objections
212k138.1 k. In General. Most Cited
Cases
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.
[3] Federal Courts 170B
776
Vacated.
Karen LeCraft Henderson, Circuit Judge, filed a
dissenting opinion.
West Headnotes
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170B Federal Courts
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170BVIII(K) Scope, Standards, and Extent
170BVIII(K)4 Discretion of Lower Court
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Temporary Restraining Order. Most Cited Cases
A court of appeals reviews a district court's balancing of the four preliminary injunction factors for
abuse of discretion; insofar as the inquiry depends
upon a question of law, review is, of course, de novo.
[4] Abortion and Birth Control 4
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4 Abortion and Birth Control
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Statutes 361
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361 Statutes
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361VI(D) Retroactivity
361k278.4 Prospective Construction
361k278.5 k. In General. Most Cited
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The use of the present tense in a statute strongly
suggests it does not extend to past actions. 1 U.S.C.A.
§ 1.
[6] Abortion and Birth Control 4
Statutes 361
361 Statutes
361VI Construction and Operation
361VI(A) General Rules of Construction
361k213 Extrinsic Aids to Construction
361k219 Executive Construction
361k219(6) Particular Federal Statutes
361k219(6.1) k. In General. Most
Cited Cases
Text of Dickey–Wicker Amendment, which
barred 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, was ambiguous as to whether it
barred funding for any project using embryonic stem
cells (ESC), such that deference to administering
agency's interpretation was warranted under Chevron
as long as it reflected a permissible construction.
Public Health Service Act, § 498(b), 42 U.S.C.A.
289g(b); 45 C.F.R. 46.204(b).
[5] Statutes 361
126
219(6.1)
198
361 Statutes
361VI Construction and Operation
361VI(A) General Rules of Construction
361k187 Meaning of Language
361k198 k. Tense of Words. Most Cited
4 Abortion and Birth Control
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National Institutes of Health's (NIH) determination that ambiguous text of Dickey–Wicker Amendment, which prohibited funding for “research in which
a human embryo or embryos are destroyed,” did not
bar its funding a project using an embryonic stem cell
(ESC) that was previously derived because a stem cell
was not an “embryo” and could not develop into a
human being, was reasonable, and thus entitled to
Chevron deference, in light of the language of the
statute and Congress's continued reenactment of the
amendment unchanged year after year. Public Health
Service Act, § 498(b), 42 U.S.C.A. 289g(b); 45 C.F.R.
46.204(b).
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212 Injunction
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Although ordinarily a court of appeals may affirm
the judgment of the district court on the basis of a
different legal theory, the decision whether to grant a
preliminary injunction is a matter of discretion, not a
question of right; it is for the district court to determine, in the first instance, whether the plaintiffs'
showing on a particular claim warrants preliminary
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injunctive relief.
[8] Abortion and Birth Control 4
126
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.
4 Abortion and Birth Control
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Dorinda C. Bordlee was on the brief for amicus curiae
Maureen L. Condic in support of appellee.
Injunction 212
Before: GINSBURG, HENDERSON, and GRIFFITH, Circuit Judges.
138.66
212 Injunction
212IV Preliminary and Interlocutory Injunctions
212IV(A) Grounds and Proceedings to Procure
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Municipalities; Schools and Colleges
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Money; Welfare and Social Security Benefits. Most
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Balance of equities tilted against granting preliminary injunction enjoining the National Institutes of
Health (NIH) from funding research using human
embryonic stem cells (ESCs) pursuant to the NIH's
guidelines; injunction would preclude the NIH from
funding new ESC projects and would bar further
disbursements to ESC researchers who had already
begun multi-year projects in reliance upon a grant
from the NIH, leaving their researchers' investments
in project planning a loss, their expenditures for
equipment a waste, and their staffs out of a job.
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.
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.
Opinion for the Court filed by Circuit Judge GINSBURG.
Dissenting opinion filed by Circuit Judge HENDERSON.
GINSBURG, Circuit Judge:
*1 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 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.
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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 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:
*2 (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 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 human embryos is prohibited by ... the Dickey–Wicker Amendment.” Id. at 32,175/2. The Guidelines further addressed Dickey–Wicker as follows:
*3 Since 1999, the Department of Health and Human Services (HHS) has consistently interpreted
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[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 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.
II. Analysis
*4 [1][2] 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., 555
U.S. 7, 129 S.Ct. 365, 376, 172 L.Ed.2d 249 (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.
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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 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, –––U.S. ––––, 129
S.Ct. 1749, 1763, 173 L.Ed.2d 550 (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, 632 F.3d 1127,
1130–35 (9th Cir.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.
*5 [3] 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. 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, 104 S.Ct. 2778, 81 L.Ed.2d 694 (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
[4] 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 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.”
[5] 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, ––– U.S. ––––, 130
S.Ct. 2229, 2236, 176 L.Ed.2d 1152 (2010). The
context here does not, as our dissenting colleague
would have it, indicate a different understanding. To
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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.FN*
*6 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.FN* 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
[6] 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, 104 S.Ct. 2778. 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 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 in which an
embryo is destroyed. See Nat'l R.R. Passenger Corp.
v. Boston & Maine Corp., 503 U.S. 407, 420, 112
S.Ct. 1394, 118 L.Ed.2d 52 (1992) (that agency's
“interpretation of the word ‘required’ ” was implicit
“does not mean that we may not defer to that interpretation”).
*7 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 –––– 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
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(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 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.FN* The fact is the statute is not worded precisely
enough to resolve the present definitional contest
conclusively for one side or the other.
*8 Broadening our focus slightly, however, we
can see the words surrounding “research” in the statute
support the NIH's 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, 122 S.Ct. 1265, 152
L.Ed.2d 330 (2002); accord Lindahl v. OPM, 470 U.S.
768, 782 n. 15, 105 S.Ct. 1620, 84 L.Ed.2d 674 (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)).FN*
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.FN* 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, 113 S.Ct.
1439, 123 L.Ed.2d 1 (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,
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499 U.S. 606, 619, 111 S.Ct. 1539, 113 L.Ed.2d 675
(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' ”).FN**
*9 [7] 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 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. Metropolitan 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 ––––, 129 S.Ct. at 374. Because it does not, we
need not consider either of the other two factors.
B. Balance of the Equities
[8] 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.
*10 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
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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 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 ––––, ––––, ––––, narrowing the verb phrase
“are destroyed” to an unintended scope, id. at ––––,
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 –––– n. *,
my colleagues perform linguistic jujitsu. I must
therefore respectfully dissent.
*11 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 contem-
plated in the Guidelines.” Order, Sherley v. Sebelius,
704 F.Supp.2d 63 (D.D.C.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
––––. 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,
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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 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, 104 S.Ct. 2778,
81 L.Ed.2d 694 (1984). Chevron step one asks if the
“Congress has directly spoken to the precise question
at issue.” Id. at 842, 104 S.Ct. 2778. “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, 104 S.Ct. 2778.
*12 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 ––––
(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. Paul Fire & Marine Ins. Co., 566
F.3d 150, 158–59 (4th Cir.2009) (describing “syste-
matic” 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 –––– –
––––. 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, 93 S.Ct. 477, 34
L.Ed.2d 446 (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 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.
*13 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
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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 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. 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 C.F.R. 46.204(b),” the
Congress unambiguously manifested its intent that
“research” as used in the Amendment is to have the
same meaning as “research” used in section
46.204(b).FN1 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,
115 S.Ct. 552, 130 L.Ed.2d 462 (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 neces-
sary 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 Amendment prohibits the expenditure of federal funds to engage in hESC research
in all of its sequences.
*14 In my view, the majority opinion strains
mightily to find the ambiguity the Government
presses.FN2 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 –––– (emphases added).FN3 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, –––
U.S. ––––, 130 S.Ct. 2229, 2236, 176 L.Ed.2d 1152
(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, 117 S.Ct. 2059, 138
L.Ed.2d 481 (1997) (“one has to strain to find ... ambiguity” in reading statutory provision that “is 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, 112 S.Ct. 52, 116
L.Ed.2d 29 (1991); Bell v. Maryland, 378 U.S. 226,
236, 84 S.Ct. 1814, 12 L.Ed.2d 822 (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
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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, 636 F.3d 752, 756–57 (5th Cir.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); 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.FN4 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.”
*15 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 ––––
– ––––, –––– – ––––, ––––. 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)). 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.FN5
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,
106 S.Ct. 3245, 92 L.Ed.2d 675 (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, 115 S.Ct. 552, 130 L.Ed.2d 462 (1994)
(quoting Demarest v. Manspeaker, 498 U.S. 184, 190,
111 S.Ct. 599, 112 L.Ed.2d 608 (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, 115 S.Ct. 552.FN6 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.FN7 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
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opinion now dismisses their injury as “necessarily
uncertain.” Maj. Op. at ––––. 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 –––– – ––––, “[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.
*16 For the foregoing reasons, I respectfully
dissent.
FN* 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.”
FN* The plaintiffs rely upon Merck KGaA v.
Integra Lifesciences I, Ltd., 545 U.S. 193,
202, 125 S.Ct. 2372, 162 L.Ed.2d 160
(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, 125 S.Ct.
2372.
FN* 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.
FN* 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 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).
FN* 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.
FN** 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. Army 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 “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
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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, 123 S.Ct. 2026, 155 L.Ed.2d 1017
(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.
FN1. 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.”
FN2. 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”).
FN3. 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, 36 F.Supp.2d 1118 (E.D.Ark.1999),
at 57–58 (Aug. 17, 1998))).
FN4. Moreover, the Amendment combines
the present tense “are” with the past parti-
ciple “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, 128 S.Ct. 2326, 171 L.Ed.2d 203
(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).
FN5. Likewise, the sequenced action inherent in “research,” supra pp. –––– – ––––,
does not equate to individual research
“projects.”
FN6. 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.
FN7. 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
himself. Maj. Op. at –––– – ––––. 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, 107 S.Ct. 2095, 95
L.Ed.2d 697 (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
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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, 113 S.Ct. 1439, 123 L.Ed.2d 1 (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, 123 S.Ct. 2026, 155 L.Ed.2d 1017
(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, 113 S.Ct. 1439. But see
id. at 309–15, 113 S.Ct. 1439 (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, 112 S.Ct. 551, 116
L.Ed.2d 546 (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., 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).
C.A.D.C.,2011.
Sherley v. Sebelius
--- F.3d ----, 2011 WL 1599685 (C.A.D.C.)
END OF DOCUMENT
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