James Sherley v. Kathleen Sebelius

United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued April 23, 2012 Decided August 24, 2012
No. 11-5241
JAMES L. SHERLEY, DR. AND THERESA DEISHER, DR.,
APPELLANTS
v.
KATHLEEN SEBELIUS, IN HER OFFICIAL CAPACITY AS
SECRETARY OF THE DEPARTMENT OF HEALTH AND HUMAN
SERVICES, ET AL.,
APPELLEES
Appeal from the United States District Court
for the District of Columbia
(No. 1:09-cv-01575)
Ryan J. Watson argued the cause for appellants. With him
on the briefs were Thomas G. Hungar, Thomas M. Johnson Jr.,
Samuel B. Casey, Steven H. Aden, and Blaine H. Evanson.
Adam J. White was on the brief for amici curiae Robert
George, et al. in support of appellants.
Beth S. Brinkmann, Deputy Assistant Attorney General,
U.S. Department of Justice, argued the cause for appellees.
With her on the briefs were Tony West, Assistant Attorney
General, Ronald C. Machen Jr., U.S. Attorney, and Mark B.
Stern, Stephanie R. Marcus, Abby C. Wright, and Helen L.
2
Gilbert, Attorneys. R. Craig Lawrence, Assistant U.S. Attorney,
entered an appearance.
Neal Goldfarb and Andrew T. Karron were on the brief for
amici curiae Coalition for the Advancement of Medical
Research, et al. in support of appellees.
Before: SENTELLE, Chief Judge, HENDERSON and BROWN,
Circuit Judges.
Opinion for the Court filed by Chief Judge SENTELLE.
Concurring opinion filed by Circuit Judge HENDERSON.
Concurring opinion filed by Circuit Judge BROWN.
SENTELLE, Chief Judge: Appellants are researchers in the
field of adult stem cells who oppose the use of federal funding
for the development of embryonic stem-cell research. In district
court they filed a complaint seeking declaratory and injunctive
relief against appellee Secretary of Health and Human Services’
implementation of regulations allowing federal funding of such
research. They appeal from a district court order entering
summary judgment in favor of the defendant. Because we
conclude that the district court committed no error, we affirm
the order and judgment under review.
I. The Current Litigation
In August of 2009, appellants and others filed the complaint
commencing this action against the Secretary of Health and
Human Services and the Director of the National Institutes of
Health (NIH), seeking declaratory relief that NIH Guidelines
authorizing the funding of research involving human embryonic
stem cells was unlawful under 5 U.S.C. § 706(2)(A). In addition
3
to this and other declaratory relief, the complaint sought to have
the court enjoin the defendants and their agencies from
implementing, applying, or taking any action pursuant to the
guidelines, or otherwise funding any research involving human
embryonic stem cells. The district court ruled that none of the
several plaintiffs had standing to bring the action and therefore
dismissed it. See Sherley v. Sebelius, 686 F. Supp. 2d 1 (D.D.C.
2009). We reversed as to the two appellants now before the
court, researchers in the field of adult stem cells, concluding that
they have standing as competitors to bring these claims. Sherley
v. Sebelius, 610 F.3d 69, 72-74 (D.C. Cir. 2010). We remanded
the case to the district court for further proceedings. Id. at 75.
On remand, the district court determined that Congress had, in
an Appropriations Act rider called the Dickey-Wicker
Amendment, clearly “provide[d] that no federal funds shall be
used 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 other regulatory and statutory regimes. Sherley v.
Sebelius, 704 F. Supp. 2d 63, 70 (D.D.C. 2010) (quoting Pub. L.
No. 111-8, § 508(a)(2)). The district court further concluded
that the guidelines under litigation violated that statutory
prohibition, that the plaintiffs demonstrated a strong likelihood
of success on the merits, that the plaintiffs would suffer
irreparable harm in the absence of preliminary injunction, that
the balance of hardships weighed in favor of preliminary
injunction, and that public interest weighed in favor of the
issuance of a preliminary injunction. The court therefore
entered the preliminary injunction sought by plaintiffs.
Defendants appealed.
On appeal, we determined that NIH had reasonably
interpreted the Dickey-Wicker Amendment and vacated the
preliminary injunction entered by the district court. Sherley v.
Sebelius, 644 F.3d 388, 390 (D.C. Cir. 2011). After the second
4
remand, the district court entered the summary judgment in
favor of defendant now under review.
II. Background
The relevant facts are set forth in our opinion reviewing the
preliminary injunction, see Sherley, 644 F.3d at 389-92, and in
the two opinions of the district court, so we shall review them
but briefly. Beginning in 1996, Congress has regularly included
in appropriation bills a rider called the Dickey-Wicker
Amendment, see, e.g., Consolidated Appropriations Act, 2012,
Pub. L. No. 112-74, § 508. The Dickey-Wicker Amendment
prohibits 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 [42 U.S.C. § 289g(b)].” Id.
At the time of the adoption of the first Dickey-Wicker rider,
scientists had not yet isolated embryonic stem cells (ESC), and
the original enactment was apparently directed at another type
of research performed on human embryos in the field of in vitro
fertilization. Sherley, 644 F.3d at 390. By 1998, researchers
had generated a stable line of ESCs available for further
research. Although more mature stem cells were and remain
available, many researchers consider the ESCs far more valuable
because they are pluripotent—that is, they can be developed into
any of nearly 200 different types of human cells for use in a
broad range of medical research.
Isolating ESCs for research requires that the cells be
removed from a human embryo, cultured, and stabilized into a
“stem cell line.” This process of “derivation” destroys the
embryo. The cells from this line may then be used for years by
5
researchers, who differentiate the cells into whatever kinds of
cells they need for a particular research project. Thus, the initial
derivation process requires the destruction of a human embryo.
The particular research projects using the earlier derived stem
cells, however, does not involve the destruction of any further
embryos.
It is this distinction between funding research projects
directly involving the destruction of a human embryo and
projects using embryonic stem cells derived from an earlier
destruction that underlies the controversy giving rise to the
present litigation. In 2001, President George W. Bush, for
ethical reasons, declared that federal funds would be used in
research on embryonic stem cells only if such cells were drawn
from one of the sixty or so stem cell lines already existing at the
time of President Bush’s declaration. Address to the Nation on
Stem Cell Research from Crawford, Texas, 37 WEEKLY COMP.
PRES. DOC. 1149, 1151 (Aug. 9, 2001). President Bush later
formalized this policy in an Executive Order. Exec. Order No.
13,435, 72 Fed. Reg. 34,591 (June 20, 2007).
So matters stood until 2009, when President Obama issued
an Executive Order revoking Executive Order No. 13,433.
Exec. Order No. 13,505, 74 Fed. Reg. 10,667 (Mar. 11, 2009).
The Order stated that NIH “may support and conduct
responsible, scientifically worthy human stem cell research,
including human embryonic stem cell research, to the extent
permitted by law.” Id.
As required by the Executive Order and after notice and
comment, NIH issued new “Guidelines for Human Stem Cell
Research,” 74 Fed. Reg. 32,170 (July 7, 2009) (Guidelines).
The Guidelines “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
6
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. Under the
Guidelines, an ESC research project may receive NIH funding
as long as it utilizes cells from lines (1) created by in vitro
fertilization for reproductive purposes, (2) no longer needed for
that purpose, and (3) voluntarily donated by the individuals who
owned them—even if that line was derived after 2001. Id. at
32,174.
During the notice and comment proceedings, the current
appellants filed comments opposing the use of federal funds for
any embryonic stem-cell research. NIH did not respond to their
comments. After the adoption of the guidelines, appellants
brought the present action.
III. Analysis
We note at the outset that our review of the district court’s
grant of summary judgment in favor of the government is de
novo. See, e.g., Calhoun v. Johnson, 632 F.3d 1259, 1261 (D.C.
Cir. 2011). Therefore, our duty is to undertake the same
examination as did the district court. On summary judgment
review in general, that requires the court to grant summary
judgment in favor of the moving party if that party “shows that
there is no genuine dispute as to any material fact and the
movant is entitled to judgment as a matter of law.” Fed. R. Civ.
P. 56. In this court, as in the district court, the APA governs the
scope of administrative reviews such as the one before us. That
Act requires a reviewing court to “hold unlawful and set aside
agency action, findings, and conclusions found to be . . .
arbitrary, capricious, an abuse of discretion, or otherwise not in
accordance with law.” 5 U.S.C. § 706(2)(A). Thus, we, as did
the district court, must allow summary judgment for appellees,
unless appellants have produced in the record at least enough
7
support for their position to establish “a genuine dispute” as to
some material fact from which we could discern that the
adoption or implementation of the guidelines by the appellees
was “arbitrary, capricious, an abuse of discretion, or otherwise
not in accordance with law.” There is no serious dispute of fact
in this case. Appellants advance three arguments for
invalidating the NIH guidelines, each of which relies upon a
proposition of law.
1. Dickey-Wicker
Appellants’ first and principal argument is that the NIH
guidelines violate the Dickey-Wicker ban on federal funding of
“research in which a human embryo or embryos are destroyed.”
On this issue, the law of the case is established against them.
The purpose of the law-of-the-case doctrine is to ensure that
“the same issue presented a second time in the same case in the
same court should lead to the same result.” LaShawn A. v.
Barry, 87 F.3d 1389, 1393 (D.C. Cir. 1996). The courts are
appropriately “‘loathe’ to reconsider issues already decided,”
except in the case of “extraordinary circumstances such as
where the initial decision was ‘clearly erroneous and would
work a manifest injustice.’” Id. (quoting Christianson v. Colt
Indus. Operating Corp., 486 U.S. 800, 817 (1988) (quoting
Arizona v. California, 460 U.S. 605, 618 n.8 (1983))).
Appellants’ argument before us in the preliminary-injunction
review was the same as now. Specifically, they asserted then
and assert now that the Dickey-Wicker ban “unambiguously”
extends to any research project that uses ESCs. Sherley, 644
F.3d at 395. Their argument, now and before, is that if a funded
research project involves the use of an ESC, then an embryo
necessarily has been destroyed, and the ban of Dickey-Wicker
has been violated. See generally id. at 393-94. Briefly put,
appellants contend that all ESC research is “research” in which
8
a human embryo or embryos are destroyed and, therefore, NIH’s
guidelines violate Dickey-Wicker by authorizing federal funding
of such research. This is precisely the same argument we
rejected in our review of the preliminary injunction order.
Applying Chevron analysis, see Chevron U.S.A., Inc., v.
NRDC, 467 U.S. 837, 842-43 (1984), we held that NIH had
reasonably interpreted Dickey-Wicker’s ban on funding
“research in which . . . embryos are destroyed” to allow federal
funding of ESC research. Sherley, 644 F.3d at 393-96. We
explained that “research” as used in Dickey-Wicker was a
“flexible” (i.e., ambiguous) term. Id. at 394. It could be
understood as the plaintiffs construed the term—an “extended
process” that would include the initial derivation of stem cells.
Or “research” could take on NIH’s narrow interpretation as a
“discrete project” separate from derivation. Id. Given that
ambiguity, we deferred under Chevron to NIH’s permissible
construction of Dickey-Wicker: “research” as used in Dickey-
Wicker may reasonably be understood to mean a “discrete
endeavor” that excludes the initial derivation of ESCs. Id. at
396 n.*. Under that interpretation, Dickey-Wicker permits
federal funding of research projects that utilize already-derived
ESCs—which are not themselves embryos—because no “human
embryo or embryos are destroyed” in such projects. Id. at 393-
96 (emphasis added). Plaintiffs’ argument on this theory for
relief is no different than it was in our prior review. Therefore,
unless they have established some “extraordinary circumstance,”
LaShawn A., 87 F.3d at 1393, the law of the case is established
and we will not revisit the issue.
Appellants have offered an exception to the law-of-the-case
doctrine which they argue should permit us to revisit the issue.
As they point out, we have held that “the decision of a trial or
appellate court whether to grant or deny a preliminary injunction
does not constitute law of the case for the purpose of further
9
proceedings and does not limit or preclude the parties from
litigating the merits.” Berrigan v. Sigler, 499 F.2d 514, 518
(D.C. Cir. 1974); see also Belbacha v. Bush, 520 F.3d 452, 458
(D.C. Cir. 2008). Therefore, appellants reason, we are not
bound by our prior determination in the review of the grant of
preliminary injunction. However, on the facts of this case, the
exception to the law-of-the-case doctrine is inapplicable.
The generally recognized precedent for the preliminary
injunction exception to the law-of-the-case doctrine arises from
the nature of a preliminary injunction. That equitable remedy is
a stopgap measure, generally limited as to time, and intended to
maintain a status quo or “to preserve the relative positions of the
parties until a trial on the merits can be held.” Univ. of Texas v.
Camenisch, 451 U.S. 390, 395 (1981). In trial court, this would
mean that a determination had been made without discovery or
the other full range of exploratory and preparatory pretrial
procedures and without a full trial on the merits. In appellate
review, the court of appeals must often consider such
preliminary relief without the benefit of a fully developed record
and often on briefing and argument abbreviated or eliminated by
time considerations. See, e.g., Cohen v. Brown Univ., 101 F.3d
155, 169 (1st Cir. 1996). Thus arose the exception to the law-
of-the-case doctrine. An appellate court in a later phase of the
litigation with a fully developed record, full briefing and
argument, and fully developed consideration of the issue need
not bind itself to the time-pressured decision it earlier made on
a less adequate record.
Furthermore, independent of the preliminary-injunction
exception, a decision in the preliminary-injunction context may
fail to garner law-of-the-case effect simply because it fails to
satisfy an element of the law-of-the-case rule itself: the
requirement that a court must “affirmatively decide[ ]” an issue,
explicitly or by necessary implication, to establish law of the
10
case. Crocker v. Piedmont Aviation, Inc., 49 F.3d 735, 739
(D.C. Cir. 1995). The standard for granting a preliminary
injunction essentially asks—in part—whether a plaintiff is
“likely to succeed on the merits” of his claim. See, e.g., Winter
v. NRDC, Inc., 555 U.S. 7, 20 (2008). To the extent an appellate
court predicts, without making a definitive legal conclusion, that
the plaintiffs probably or likely will or will not succeed on the
merits, it cannot be said that the court “affirmatively decided”
the issue such that it would bind an appellate court at a later
stage of the litigation.
The question raised by this appeal is whether we should
apply the preliminary-injunction exception to the law-of-the-
case preclusion where the reasons for its application are absent.
That is, where the earlier ruling, though on preliminary-
injunction review, was established in a definitive, fully
considered legal decision based on a fully developed factual
record and a decisionmaking process that included full briefing
and argument without unusual time constraints, why should we
not follow the usual law-of-the-case jurisprudence? While we
have not previously provided a definitive answer to that
question, several other circuits and commentators have.
For example, in Naser Jewelers, Inc. v. City of Concord,
538 F.3d 17 (1st Cir. 2008), the First Circuit considered an
appeal from summary judgment upholding a city ordinance
against a First Amendment challenge. The circuit had
previously affirmed the denial of preliminary injunction in the
same case. In holding that the law-of-the-case doctrine applied,
even though the first decision was in the denial of a preliminary
injunction and the second appeal was from the entry of summary
judgment, that circuit noted that “the doctrine applies when [the]
court has previously ruled on a motion for preliminary
injunction and ‘the record before the prior panel was sufficiently
developed and the facts necessary to shape the prior legal matrix
11
were sufficiently clear.’” Id. at 20 (quoting Cohen v. Brown
Univ., 101 F.3d 155, 169 (1st Cir. 1996) (other citations,
quotation marks, and alterations omitted)).
In This That and The Other Gift and Tobacco, Inc. v. Cobb
County, 439 F.3d 1275, 1284-85 (11th Cir. 2006), the Eleventh
Circuit reached a similar decision, citing its own precedent to
the effect that prior clear legal conclusions reached at the
preliminary injunction stage would be afforded law-of-the-case
status. In Entergy, Arkansas, Inc. v. Nebraska, 241 F.3d 979,
987 (8th Cir. 2001), the Eighth Circuit afforded law-of-the-case
status to an Eleventh Amendment issue “carefully considered”
in deciding the course of the preliminary injunction appeal. And
in Royal Insurance Co. of America v. Quinn-L Capital Corp., 3
F.3d 877, 880-81 (5th Cir. 1993), the Fifth Circuit ruled to the
same effect. One of the leading commentators on federal
jurisprudence has stated, “A fully considered appellate ruling on
an issue of law made on a preliminary injunction appeal,
however, does become the law of the case for further
proceedings in the trial court on remand and in any subsequent
appeal.” 18B Charles A. Wright et al., Fed. Prac. & Proc. Juris.
§ 4478.5 (2d ed.).
Appellants insist application of the preliminary injunction
exception is mandated by circuit precedent. For this
proposition, they rely on Berrigan and Belbacha. They note that
in Berrigan, we stated, “The decision of a trial or appellate court
whether to grant or deny a preliminary injunction does not
constitute the law of the case for the purposes of further
proceedings and does not limit or preclude the parties from
litigating the merits, unless there has been an order of
consolidation pursuant to Rule 65(a)(2), not the case here.” 499
F.2d at 518. In Belbacha, we stated, “An order denying
preliminary relief, however, ‘does not constitute the law of the
case,’ although it can be ‘persuasive.’” 520 F.3d at 458 (quoting
12
Berrigan). No doubt these cases state the generally applicable
rule for preliminary-injunction decisions. However, the case
before us is factually distinguishable. The time constraints and
limited record available to the court in those cases are not
present here. We therefore follow the other circuits in
concluding that the exception is not present either. Appellants’
first argument fails.
2. Subjected to Risk
Appellants make a second argument that is intertwined with
their first. They note that Dickey-Wicker also bans “research in
which a human embryo or embryos are . . . knowingly subjected
to risk of injury or death.” § 508(a)(2). Even if the NIH
guidelines do not violate the Dickey-Wicker ban on funding
“research in which a human embryo or embryos are destroyed”
(because law of the case accorded Chevron deference to NIH’s
interpretation), appellants maintain that the guidelines still run
afoul of the “subjected to risk” language. They theorize that
conducting a federally funded ESC research project increases
the demand for more ESC lines, which in turn incentivizes the
destruction of more embryos to create those lines, thus
subjecting those embryos to risk. NIH responds that no embryos
are subjected to risk of injury or death in any ESC research
project using already derived ESCs and not otherwise involving
the use of embryos.
Although appellants can credibly argue that this precise
question of statutory interpretation is not within the law of the
case, our result is nonetheless controlled by that doctrine. Law
of the case has established that Chevron deference applies. It is
established that “research” as used in Dickey-Wicker is an
ambiguous term, and that NIH’s interpretation of the term
“research” as a discrete project rather than an extended process
is reasonable. Under that definition of “research,” the
13
destruction of embryos that occurs in the ESC derivation process
is not a part of individual ESC research projects using already
derived ESCs. Therefore, ESC research is no more “research in
which . . . embryos are . . . subjected to risk” than it was
“research in which . . . embryos are . . . destroyed.” Appellants’
theory shifts focus from the embryo destroyed in the past to
embryos for which an ESC research project “incentivizes” future
destruction. But none of those embryos are “destroyed” or
“subjected to risk” in an ESC research project. The language of
Dickey-Wicker does not ban funding for, e.g., “research which
provides an incentive to harm, destroy, or place at risk human
embryos.” As we have held before, the NIH interpretation of
the statute’s actual language is reasonable.
3. Failure to Reply to Comments
The plaintiffs finally contend that NIH violated the APA by
issuing the Guidelines without addressing comments
categorically objecting to ESC research, which the plaintiffs
consider relevant to NIH’s decision to expand the availability of
ESC research funding. While this contention remains unfettered
by decisions made in Sherley II, it fares no better than the
Dickey-Wicker arguments.
APA Section 553 requires agencies to provide the public
with notice of a proposed rulemaking, an opportunity to
comment, and, “[a]fter consideration of the relevant matter
presented,” a “concise general statement” of the rule’s basis and
purpose. 5 U.S.C. § 553. We have said before that “the
opportunity to comment is meaningless unless the agency
responds to significant points raised by the public.” Home Box
Office, Inc. v. FCC, 567 F.2d 9, 35-36 (D.C. Cir. 1977). That
said, an agency’s failure to address a particular comment or
category of comments is not an APA violation per se. See, e.g.,
Thompson v. Clark, 741 F.2d 401, 408 (D.C. Cir. 1984) (“[APA
14
§ 553] has never been interpreted to require the agency to
respond to every comment, or to analyze every issue or
alternative raised by the comments, no matter how
insubstantial.”). We review an agency’s response to comments
under the same arbitrary-and-capricious standard to which we
hold the rest of its actions. See Home Box Office, 567 F.2d at 35
n.58. Put simply, “The failure to respond to comments is
significant only insofar as it demonstrates that the agency’s
decision was not based on a consideration of the relevant
factors.” Covad Commc’ns v. FCC, 450 F.3d 528, 550 (D.C.
Cir. 2006) (quoting Thompson, 741 F.2d at 409).
The comments identified by appellants cited scientific and
ethical problems with ESC research and categorically objected
to funding any ESC research at all. They advocated funding
other types of stem-cell research instead. Crucially, however,
this recommended course of action is diametrically opposed to
the direction of Executive Order 13,505, which NIH sought to
“implement” by issuing the Guidelines, see 74 Fed. Reg. at
32,170. That Order makes it quite plain that its dominant
purpose was to “remove” President Bush’s 2001 “limitations”
on funding human ESC research and to “expand” NIH support
for human stem-cell research, “including human embryonic stem
cell research.” See 74 Fed. Reg. at 10,667, §§ 1-2 (titled
“Removing Barriers to Responsible Scientific Research
Involving Human Stem Cells”). Yet the comments at issue
advocate ending all ESC research funding—even for research
that has been eligible for funding for a decade under the 2001
restrictions. Following these commenters’ lead would directly
oppose the clear import of the Executive Order, which sought to
remove limitations on ESC research and to expand NIH support
for stem-cell research.
NIH may not simply disregard an Executive Order. To the
contrary, as an agency under the direction of the executive
15
branch, it must implement the President’s policy directives to
the extent permitted by law. See Bldg. & Const. Trades Dept.
v. Allbaugh, 295 F.3d 28, 32-33 (D.C. Cir. 2002) (citing THE
FEDERALIST NO. 72, at 463 (Alexander Hamilton) (Benjamin F.
Wright ed., 1961)). Bound as it is to carry out the President’s
directives, NIH thus reasonably limited the scope of its
Guidelines to implement the Executive Order. And because the
Executive Order’s entire thrust was aimed at expanding support
of stem-cell research, it was not arbitrary or capricious for NIH
to disregard comments that instead called for termination of all
ESC research (including research that the executive branch has
permitted since 2001). Such comments simply did not address
any factor relevant to implementing the Executive Order.
While the district court also rejected the plaintiffs’ APA
claim, it did so by relying in part on its holding that NIH’s
interpretation of the Executive Order deserved deference under
Udall v. Tallman, 380 U.S. 1, 16-17 (1965). The plaintiffs
claim that such deference is unwarranted for a variety of
reasons. We have no reason to resolve this argument here. We
need not rely on deference to NIH’s interpretation of Executive
Order 13,505 to conclude that NIH’s choice to disregard the
comments at issue was not arbitrary or capricious. NIH stated
that the scope of its Guidelines was to “implement Executive
Order 13505,” 74 Fed. Reg. at 32,174, and that Order plainly
starts from the premise that NIH should continue to fund at least
some ESC research. NIH’s decision to dismiss comments
seeking to reopen that premise for debate therefore did not
demonstrate a failure to consider relevant factors.
Conclusion
For the above reasons, we affirm the district court’s grant
of summary judgment in favor of the government.
So ordered.
KAREN LECRAFT HENDERSON, Circuit Judge, concurring:
My colleagues correctly note that Sherley v. Sebelius, 644
F.3d 388 (D.C. Cir. 2011) (Sherley I), applied Chevron to
uphold the National Institute of Health (NIH) Guidelines for
Human Stem Cell Research, 74 Fed. Reg. 32,170 (July 7, 2009)
(Guidelines). See Maj. Op. at 8. Although the law of the case
prevents us from reconsidering that holding, I write separately
for the record to point out that Chevron review is inapplicable to
the Guidelines.
“Not every agency interpretation of a statute is
appropriately analyzed under Chevron.” Ala. Educ. Ass’n v.
Chao, 455 F.3d 386, 392-93 (D.C. Cir. 2006). Chevron applies
only “when it appears that Congress delegated authority to the
agency generally to make rules carrying the force of law, and
that the agency interpretation claiming deference was
promulgated in the exercise of that authority.’ ” United States v.
Mead Corp., 533 U.S. 218, 226-27 (2001)). In short, we accord
Chevron deference only when reviewing an agency’s
“construction of a statutory scheme it is entrusted to
administer.” Id. at 227-28 (quoting Chevron, 467 U.S. at 844)
(emphasis added). “[W]hen an agency interprets a statute other
than that which it has been entrusted to administer, its
interpretation is not entitled to [Chevron] deference.” Dep’t of
Treasury v. FLRA, 837 F.2d 1163, 1167 (D.C. Cir. 1988).
NIH’s construction of the Dickey-Wicker Amendment falls
outside the Chevron ambit because NIH was not charged with
administering the Amendment, as is obvious from both its
language and its substance.
First, the Amendment’s language makes clear its
administration is not within the exclusive province of NIH or its
parent agency, the Department of Health and Human Services.
It has been enacted annually as a rider to an omnibus
appropriations act, in a division governing “Departments of
Labor, Health and Human Services, and Education, and Related
Agencies Appropriations.” Consolidated Appropriations Act of
2012, Pub. L. No. 112-74, div. F., § 508(a), 125 Stat. 786, 1112
2
(2011) (emphasis added); see also, e.g., Consolidated
Appropriations Act of 2011, Pub. L. No. 111-117, div. D,
§ 509(a), 123 Stat. 3034, 3280-81 (2010) (same division title);
Omnibus Appropriations Act of 2010, Pub. L. No. 111-8,
§ 509(a), div. F, 123 Stat. 524, 803 (2009) (same). Because
each annual rider by its terms applies generally to multiple
agencies, Chevron deference is not due any one agency’s
interpretation of its language. See Proffitt v. FDIC, 200 F.3d
855, 860 (D.C. Cir. 2000) (“When a statute is administered by
more than one agency, a particular agency’s interpretation is not
entitled to Chevron deference.”). In the past, we have “declined
to defer to an agency’s interpretation of a statute when more
than one agency is granted authority to interpret the same
statute,” reasoning that “[i]n such cases, it cannot be said that
Congress implicitly delegated to one agency authority to
reconcile ambiguities or to fill gaps, because more than one
agency will independently interpret the statute.” Salleh v.
Christopher, 85 F.3d 689, 692 (D.C. Cir. 1996) (citing, e.g.,
Rapaport v. U.S. Dep’t of Treasury, 59 F.3d 212, 216-17 (D.C.
Cir. 1995), cert. denied, 516 U.S. 1073 (1996); Benavides v.
U.S. Bureau of Prisons, 995 F.2d 269, 272 n.2 (D.C. Cir. 1993);
Prof’l Reactor Operator Soc’y v. U.S. Nuclear Regulatory
Comm’n, 939 F.2d 1047, 1051 (D.C. Cir. 1991)). Sherley I
therefore erred in applying Chevron to NIH’s interpretation.
Second, the Amendment, as a rider to a federal
appropriations statute, is “not within [any agency’s] area of
expertise” and therefore a particular agency’s interpretation
thereof “receives no deference.” U.S. Dep’t of Navy v. FLRA,
665 F.3d 1339, 1348 (D.C. Cir. 2012); see, e.g., Ass’n of
Civilian Technicians, Tony Kempenich Mem’l Ch. 21 v. FLRA,
269 F.3d 1119, 1121 (D.C. Cir. 2001) (court does not defer to
FLRA’s “interpretation of the Department of Defense
Appropriations Act, a statute not committed to the Authority's
administration” but “reviews such purely legal questions de
novo”). Indeed the rider’s language reveals no express
3
delegation of authority—implicit or explicit—to any agency to
administer its provisions—which is unsurprising given that the
rider itself confers no substantive authority on any agency to do
anything; it simply—and plainly—prohibits the Departments of
Labor, Health and Human Services and Education, as well as
“[r]elated [a]gencies,” from using the appropriated funds for the
specifically enumerated purposes.
Because the Dickey-Wicker Amendment does not delegate
administrative authority to the Department of Health and Human
Services or to NIH, I believe that Sherley I incorrectly applied
the Chevron framework. See 644 F.3d at 392 (D.C. Cir. 2011)
(“We approach this issue under the familiar two-step framework
of Chevron . . . .”). The court should instead have interpreted
the statute de novo, according no deference to NIH’s
interpretation.* See Ass’n of Civilian Technicians, 269 F.3d at
1121; Proffitt, 200 F.3d at 860; see also Dep’t of Treasury, 837
F.3d at 1167 (“Because the FLRA’s refusal to award back pay
did not rest on an interpretation of its organic statute, but rather
on its reading of the Back Pay Act—a general statute—the
FLRA’s interpretation is entitled to respect before this court, but
we are not bound by its construction of the statute even if
reasonable.”). Had we done so, I believe we would have
invalidated the Guidelines as contrary to the Amendment’s plain
and unambiguous text. See Sherley I, 644 F.3d at 400-02
(Henderson, J., dissenting) (Sherley I Dissent).
*
Even so-called Skidmore deference is not available because it
also applies only to an agency interpretation of a statute the agency
administers. See United States v. Mead Corp., 533 U.S. at 228 (under
Skidmore v. Swift & Co., 323 U.S. 134 (1944), “[t]he fair measure of
deference to an agency administering its own statute has been
understood to vary with circumstances, and courts have looked to the
degree of the agency’s care, its consistency, formality, and relative
expertness, and to the persuasiveness of the agency’s position”)
(footnotes omitted).
4
The Amendment prohibits federal funding of ‘‘research in
which a human embryo or embryos are destroyed.” Pub. L. No.
112-74 § 508(a)(1). Contrary to the holding in Sherley I, this
ban plainly prohibits federal funding that the Guidelines
expressly permit—namely, the funding of human embryonic
stem cell (hESC) research that is conducted after the destruction
of the embryo. See 74 Fed. Reg. at 32,174. This conclusion is
compelled by the dictionary definition of “research” as a
“systematic inquiry or investigation,” which necessarily includes
not only “the first sequence of hESC research [involving ] the
derivation of stem cells from the human embryo” but also “the
succeeding sequences of hESC research.” Sherley I Dissent, 644
F.3d at 401. The Sherley I majority, however, ignored the
Amendment’s plain meaning, manufacturing ambiguity where
there was none. Sherley I Dissent, 644 F.3d at 399, 402-05.
Nevertheless, Sherley I’s Chevron step-two analysis is the law
of the case and we are bound thereby. See Maj. Op. at 7-12.
BROWN, Circuit Judge, concurring: Despite many points
of agreement with my colleagues, I write separately because
we converge from different paths and there are aspects of this
case that—NIH’s insouciance notwithstanding—should
trouble the heart. Even Dr. James Thompson, the researcher
credited with being the first to successfully derive human
embryonic stem cells, has admitted: “If human embryonic
stem cell research does not make you at least a bit
uncomfortable, you have not thought about it enough.” Gina
Kolata, Man Who Helped Start Stem Cell War May End It,
N.Y. TIMES, Nov. 22, 2007.
I. Chevron Deference
If this was ever a simple case it long ago ceased to be one.
The judiciary, the executive branch, the scientific community,
and numerous legal commentators have put forth disparate
interpretations of the Congressional prohibition on the use of
federal funds for stem cell research. 1 Legislators, too, express
1
See, e.g., Sherley v. Sebelius, 704 F. Supp. 2d 63 (D.D.C. 2009);
Jenny Shum, Moral Disharmony: Human Embryonic Stem Cell
Patent Laws, WARF, and Public Policy, 33 B.C. INT’L & COMP. L.
REV. 153, 163 (2010) (“Essentially, the amendment rendered any
scientific research on hESCs ineligible for federal funding.”);
Ronald Green, Political Interventions in U.S. Human Embryo
Research: An Ethical Assessment, 38 J.L. MED. & ETHICS 220, 224
(2010) (“Dickey-Wicker not only prohibits research that risks or
destroys an embryo—applying to embryos whether in vitro or in
utero the same protections applied to fetuses and even more
stringent protections than those afforded children—but it defines
the embryo as any organism produced by fertilization,
parthenogenesis, cloning, or any other means from one or more
human gametes”); Maite S. Kollmann, Taking the Moral High
Road: Why Embryonic Stem Cell Research Should Be Strictly
2
conflicting views. 2 Disagreement is inevitable when what lies
at the core of the dispute is a profound question about the
boundaries of science—one that is irreducibly controversial
because the slippery slope is precipitous in both directions.
Ours, though, is not the legislative burden of bringing
considered resolution to this contested question. We ponder a
much narrower, much more prosaic query that serves only as
a rough proxy for the metaphysics: does the Dickey-Wicker
Amendment’s prohibition on federal funding of “research in
which a human embryo or embryos are destroyed” or
“knowingly subjected to the risk of death or injury,” Pub. L.
No.112-74, sec. 508(a)(1–2), preclude federal funding for all
human embryonic stem cell research? And how much
deference, if any, should be accorded to the agency’s view
that stem cell research can be decoupled from the derivation
of the stem cell line?
Regulated, 2 FAULKNER L. REV. 145, 155 (2010) (“[NIH] General
Counsel Rabb concluded that the Dickey-Wicker Amendment,
which prohibited the use of funds allocated to the HHS for human
embryo research, would not be applicable to research using hESCs
‘because such cells are not a human embryo within the statutory
definition.’”).
2
In the Senate hearing convened to respond to the district court’s
initial injunction in this case, Senator Wicker maintained that “if
human embryonic stem cell research is to be done at all, it should
be paid for with nontaxpayer funds.” The Promise of Human
Embryonic Stem Cell Research: Hearing before S. Subcomm. on
Appropriations, Statement of Sen. Roger Wicker, 111th Cong. 3–4
(2010). In the same hearing, Senator Feinstein excoriated the
District court’s “alarming” decision as “an unprecedented and
highly restrictive interpretation of the Dickey-Wicker amendment.”
The Promise of Human Embryonic Stem Cell Research: Hearing
before S. Subcomm. on Appropriations, Statement of Sen. Dianne
Feinstein, 111th Cong. 33 (2010).
3
Every substantive decision in this case’s checkered past
has proceeded under the assumption that Chevron U.S.A. Inc.
v. Natural Resources Defense Council, Inc., 467 U.S. 837(1984), controls the statutory interpretation. I thus
welcome—and heartily concur with—the portion of Judge
Henderson’s concurring opinion dealing with this threshold
determination. Like her, I conclude Chevron does not apply
and the court should have accorded no deference to NIH’s
interpretation. See AKM LLC dba Volks Constructors v. Sec.
of Labor, 675 F.3d 752, 764–69 (D.C. 2012) (Brown, J.,
concurring). But in this case, deference is not dispositive.
Judge Henderson finds the Amendment’s ban “plainly
prohibits federal funding that the Guidelines expressly
permit—namely, the funding of human embryonic stem cell
(hESC) research that is conducted after destruction of the
embryo.” Concurrence at 4 (Henderson, J.). I am not so
sanguine. Judge Henderson’s reading is certainly plausible
and undoubtedly consistent with the initial conclusion of the
trial court that the language “reflects the unambiguous intent
of Congress to enact a broad prohibition of funding research
in which a human embryo is destroyed.” Sherley v. Sebelius,
704 F. Supp. 2d 63, 70–71 (D.D.C. 2010). But it still does not
tell us how to define “research” in light of the many layers of
executive orders, agency interpretation, and legislative
acquiescence with which we must now deal.
Congressional efforts to grapple with the ethical
challenges arising from the extraordinary advances in
biomedicine and biotechnology date back at least to the
passage of the National Research Act in 1974. See Pub. L.
No. 93-348, 88 Stat. 342. Since then, there has been no
shortage of committees, boards, and panels all dedicated to
the study and consideration of the moral, legal, and ethical
dimensions of using human subjects, or human cellular or
4
genetic materials, in scientific experiments. 3 More recently,
Congress passed the NIH Revitalization Act of 1993, Pub. L.
103-43, under which NIH established the Human Embryo
Research Panel (“HERP”). While the bill’s focus was human
reproductive biology, HERP concluded that “[r]esearch
involving the development of embryonic stem cells [done]
with embryos resulting from IVF treatment for infertility or
clinical research that have been donated” was “acceptable”
and could receive federal funding. Human Embryo Research
Panel, Volume I of the Report of the Human Embryo
Research Panel, 75–76 (September 1994). 4
Congress passed the Dickey-Wicker Amendment in 1996
partially in response to some of HERP’s bolder
recommendations, perhaps agreeing with the Washington Post
that the Panel had gone “a step too far.” See Green, supra, at
224. The Amendment was not directed at the precise research
at issue here, 5 but whatever the Amendment’s original
purpose, President Clinton’s decision in 1999 to announce a
policy of federal funding for embryonic stem cell research—
and Congress’s decision to pass the Amendment unchanged
3
The Ethics Advisory Board (“EAB”), for example, came into
being in the late 1970s around the time scientists produced the first
test-tube baby. The EAB focused on federal support for in vitro
fertilization (“IVF”) and embryo transfer. See Ethics Advisory
Board, Report and Conclusions: HEW Support of Research
Involving Human In Vitro Fertilization and Embryo Transfer 1–7
(May 4, 1979), available at
http://bioethics.georgetown.edu/pcbe/reports/past_commissions/HE
W_IVF_report.pdf. For a list of other prominent past commissions,
see O. Carter Snead, Science, Public Bioethics, and the Problem of
Integration, 43 U.C. DAVIS L. REV. 1529, 1539 n. 32 (2010).
4
The panelists were foresighted as scientists had not yet derived
human embryonic stem cells.
5
See 142 CONG. REC. S429-01 (1996).
5
the following year—altered the interpretive calculus. See Joint
Appendix at 523. In the same vein, Congress’s decision to
pass the Amendment unchanged for all eight years of the
Bush Administration seems to confirm its acquiescence to
some federal funding of research involving human embryonic
stem cells. 6 Indeed, Congress supplemented this implicit
approval of funding for embryonic stem cell research with
contemporaneous Senate and House reports explicitly stating
that the amendment “should not be construed to limit federal
support for research involving human embryonic stem cells
listed on an NIH registry and carried out in accordance with
the policy outlined by the President.” NIH Br. at 14 (quoting
H.R. Rep. No. 107-229, at 180 (Oct. 9, 2001)).
For this reason, I am of the view that de novo review
would not change the outcome of the prior decision to affirm
NIH’s interpretation of the act. I thus join in the judgment of
the majority opinion though I would reach the decision using
the more familiar clear error standard of review under which
we must vacate the logic of the prior holding and supply our
own should we find that the prior decision was “clearly
erroneous and would work a manifest injustice.” LaShawn v.
Barry, 87 F.3d 1389, 1395 (D.C. Cir. 1996) (referencing
Christianson v. Colt Indus. Operating Corp., 486 U.S. 800,
817 (1988)). The facts in the record before us do not,
however, rise to the level of these “extraordinary
circumstances.” Id. That we have only now, some four-years
and multiple opinions later, questioned the propriety of
Chevron strongly suggests that the decisions of the reasonable
6
President Bush’s policy was decidedly narrower than that of
President Clinton, but it still authorized funding. Consequently, it
must be said to violate the appellants’ reading of the Dickey-
Wicker Amendment.
6
jurists considering these matters were not “clearly
erroneous.” 7
II. Failure to Reply to Comments
Although it is difficult to take issue with any part of the
majority’s catechism on the agency’s refusal to respond to
thousands of comments, the whole seems somewhat
problematic. Obviously, the opportunity to comment is
meaningless unless the agency responds substantively to
significant points raised by the public. But the law of this
Circuit is clear: an agency is only required to respond to
comments if, for example, it can be established that the
comment is “relevant to the agency’s decision and which, if
adopted, would require a change in [the] agency’s proposed
rule, Home Box Office, Inc. v. FCC, 567 F.2d 9, 35 n. 58
(D.C. Cir. 1977), or that a failure to respond would
“demonstrate[] that the agency’s decision was not based on a
consideration of the relevant factors,” Covad Commc’ns Co.
v. FCC, 450 F.2d 186, 197 (D.C. Cir. 1993). In applying this
test, however, the majority defines “relevance” as coextensive
with the President’s Executive Order and does so without
imposing any clear limits on an agency’s ability to ignore
comments that contravene the executive’s policy goals. I fear
that without such boundaries there remains the distinct
possibility that the executive power will expand at the
expense of the APA’s regulatory scheme and judicial review
will be reduced to rubberstamping preordained results.
7
When the dust settles and the votes are tallied, a majority of this
panel supports two seemingly conflicting positions: (1) that law of
the case doctrine prevents us from reconsidering the earlier ruling
that applied Chevron and (2) that Chevron does not apply. Thus, the
majority opinion stands only for the proposition that the earlier
result need not be overturned—not that the decision was correct in
all respects.
7
Clearly, if the Dickey-Wicker Amendment’s prohibition
was unambiguous, NIH could not ignore an entire class of
interpretive views because a broad reading of “research”
would run counter to the executive’s agenda. Similarly, I do
not think the agency could attempt to implement an expansive
program Congress had explicitly rejected by deeming
challenges to its authority irrelevant. But this is not the case
here. As an initial matter, the comments Appellants argue
were wrongfully ignored focus not on the text of Dickey-
Wicker or the question of legislative authorization, but on the
Executive Order’s (and the Guidelines’) requirement that only
“responsible” and “scientifically worthy” research should be
eligible for funding. Appellant Br. at 45. This is
fundamentally a policy question and we must respect the
Executive’s ability to reasonably define the contours of the
proposed rulemaking. Nor is there a conflict between
branches in NIH’s decision to couch their rejection in more
absolute terms, i.e., declaring all comments “advocating a
blanket ban on all funding for hESC research . . . not
relevant.’” See Joint App’x at 479–80. The NIH cannot be
said to have acted arbitrarily and capriciously by refusing to
re-open a debate that, as a practical matter, has been
foreclosed for more than a decade. Because I ultimately reach
the same result, I thus concur with the majority’s conclusion
and leave the more technical questions of Executive Orders
and deference for a later day.
The challenging—and constantly evolving—issues
presented by bioethics are critical and complex. Striking the
right balance is not easy and not, in the first instance, a task
for judges. What must be defended is “the integrity of science,
the legitimacy of government, and the continuing vitality” of
concepts like human dignity. 8 Given the weighty interests at
8
Snead, supra n. 3, at 1604.
8
stake in this encounter between science and ethics, relying on
an increasingly Delphic, decade-old single paragraph rider on
an appropriations bill hardly seems adequate.