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.

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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§ 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.