Lead Opinion
Opinion for the Court filed by Chief Judge SENTELLE.
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 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,
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,
II. Background
The relevant facts are set forth in our opinion reviewing the preliminary injunction, see Sherley,
At the time of the adoption of the first Dickey-Wicker rider, scientists had not yet isolated embryonic stem cells (BSC), and the original enactment was apparently directed at another type of research performed on human embryos in the field of in vitro fertilization. Sherley,
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 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
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 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,
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
Applying Chevron analysis, see Chevron U.S.A, Inc. v. NRDC,
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 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,
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
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 case. Crocker v. Piedmont Aviation, Inc.,
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,
In This That and The Other Gift and Tobacco, Inc. v. Cobb County,
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.”
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 ease 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 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
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, “[ajfter 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,
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 branch, it must implement the President’s policy directives to the extent permitted by law. See Bldg. & Const. Trades Dept. v. Allbaugh,
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,
Conclusion
For the above reasons, we affirm the district court’s grant of summary judgment in favor of the government.
So ordered.
Concurrence Opinion
concurring:
My colleagues correctly note that Sherley v. Sebelius,
“Not every agency interpretation of a statute is appropriately analyzed under Chevron.” Ala. Educ. Ass’n v. Chao,
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 enact
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
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
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,
Notes
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.,
Concurrence Opinion
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.
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.,
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 genetic materials, in scientific experiments.
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,
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,
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,
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 reopen 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.
. See, e.g., Sherley v. Sebelius,
. 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. Sub-comm. on Appropriations, Statement of Sen. Dianne Feinstein, 111th Cong. 33 (2010).
. 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 Fertiliza
. The panelists were foresighted as scientists had not yet derived human embryonic stem cells.
. See 142 Cong. Rec. S429-01 (1996).
. 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.
. 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
. Snead, supra n. 3, at 1604.
