Sherley v. Sebelius

Citation689 F.3d 776
Decision Date24 August 2012
Docket NumberNo. 11–5241.,11–5241.
PartiesJames 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.
CourtUnited States Courts of Appeals. United States Court of Appeals (District of Columbia)

OPINION TEXT STARTS HERE

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. 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 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 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 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 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 support for their position to establish “a genuine dispute” as to some material fact...

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