Sherley v. Sebelius

• Citation: 644 F.3d 388,396 U.S.App.D.C. 1
• Decision Date: 29 April 2011
• Docket Number: No. 10–5287.,10–5287.
• Parties: Dr. James L. SHERLEY, et al., Appelleesv.Kathleen SEBELIUS, in her official capacity as Secretary of the Department of Health and Human Services, et al., Appellants.
• Court: United States Courts of Appeals. United States Court of Appeals (District of Columbia)

644 F.3d 388

396 U.S.App.D.C. 1

Dr. James L. SHERLEY, et al., Appellees

v.Kathleen SEBELIUS, in her official capacity as Secretary of the Department of Health and Human Services, et al., Appellants.

No. 10–5287.

United States Court of Appeals, District of Columbia Circuit.

Argued Dec. 6, 2010.Decided April 29, 2011.

Appeal from the United States District Court for the District of Columbia (No. 1:09–cv–01575).Beth S. Brinkmann, Deputy Assistant Attorney General, U.S. Department of Justice, argued the cause for appellants. With her on the briefs were Ronald C. Machen Jr., U.S. Attorney, and Mark B. Stern, Stephanie R. Marcus, and Abby C. Wright, Attorneys. Joel McElvain, Senior Counsel, and R. Craig Lawrence, Assistant U.S. Attorney, entered appearances.Jon E. Pettibone, Neal Goldfarb, and Andrew T. Karron were on the brief for amici curiae State of Wisconsin, et al. in support of appellants.Robert P. Charrow and Laura Metcoff Klaus were on the brief for amicus curiae Regents of the University of California in support of appellants.Thomas G. Hungar argued the cause for appellees. With him on the brief were Bradley J. Lingo, Thomas M. Johnson, Jr., Ryan J. Watson, Blaine H. Evanson, Samuel B. Casey, and Steven H. Aden.Dorinda C. Bordlee was on the brief for amicus curiae Maureen L. Condic in support of appellee.Before: GINSBURG, HENDERSON, and GRIFFITH, Circuit Judges.Opinion for the Court filed by Circuit Judge GINSBURG.Dissenting opinion filed by Circuit Judge HENDERSON.GINSBURG, Circuit Judge:

Two scientists brought this suit to enjoin the National Institutes of Health from funding research using human embryonic stem cells (ESCs) pursuant to the NIH's 2009 Guidelines. The district court granted their motion for a preliminary injunction, concluding they were likely to succeed in showing the Guidelines violated the Dickey–Wicker Amendment, an appropriations rider that bars federal funding for research in which a human embryo is destroyed. We conclude the plaintiffs are unlikely to prevail because Dickey–Wicker is ambiguous and the NIH seems reasonably to have concluded that, although Dickey–Wicker bars funding for the destructive act of deriving an ESC from an embryo, it does not prohibit funding a research project in which an ESC will be used. We therefore vacate the preliminary injunction.

I. Background

As we explained at an earlier stage of this case, stem cells have the potential of yielding treatments for a wide range of afflictions because scientists can cause them to function as any one of a number of specific types of cell. 610 F.3d 69, 70 (2010) ( Sherley I ). We there considered two different classes of human stem cells: adult stem cells, which are somewhat specialized, and ESCs, which are pluripotent, meaning they can develop into nearly any of the 200 types of human cell. In addition to these two established categories, we note the recent development of induced pluripotent stem cells, which are adult stem cells reprogrammed to a stage of development at which they are pluripotent. There is some debate as to which type of stem cell holds more promise of yielding therapeutic applications.

Adult stem cells can be found in the various tissues and organs of the human body. ESCs, by contrast, can be found only in a human embryo; isolating an ESC requires removing the “inner cell mass” of the embryo, a process that destroys the embryo. The stem cells among the 30 or so cells in the inner cell mass are then placed in a culture, where they will divide continuously without differentiating, thus forming a “stem cell line” of identical cells. An individual ESC may be removed from the line without disrupting either the multiplication process or the durability of the line. The removed cell may then be used in a research project—either by the investigator who extracted it or by another—in which the ESC will be caused to develop into the type of cell pertinent to that research. Most stem cell lines are maintained by one or another of several research universities, which make them available for scientific use, usually for a small fee.

The plaintiffs in this case, Drs. James Sherley and Theresa Deisher, are scientists who use only adult stem cells in their research. They contend the NIH has, by funding research projects using ESCs, violated the Dickey–Wicker Amendment, which the Congress has included in the annual appropriation for the Department of Health and Human Services each year since 1996. Dickey–Wicker prohibits the NIH from funding:

(1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 C.F.R. 46.204(b) and section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)).

Pub.L. No. 111–117, § 509(a)(2), 123 Stat. 3034, 3280–81.

In 1996, when the Congress first passed Dickey–Wicker, scientists had taken steps to isolate ESCs but had not yet been able to stabilize them for research in the laboratory. The historical record suggests the Congress passed the Amendment chiefly to preclude President Clinton from acting upon an NIH report recommending federal funding for research using embryos that had been created for the purpose of in vitro fertilization. See O. Carter Snead, Science, Public Bioethics, and the Problem of Integration, 43 U.C. Davis L.Rev. 1529, 1546 (2010). Dickey–Wicker became directly relevant to ESCs only in 1998, when researchers at the University of Wisconsin succeeded in generating a stable line of ESCs, which they made available to investigators who might apply for NIH funding.

For that reason, on January 15, 1999, the General Counsel of the Department of Health and Human Services issued a memorandum addressing whether Dickey–Wicker permits federal funding of research using ESCs that had been derived before the funded project began; she concluded such funding is permissible because ESCs are not “embryos.” After notice and comment, the NIH issued funding guidelines consistent with this opinion, see 65 Fed.Reg. 51,976 (2000), but the NIH did not fund any ESC research project while President Clinton was in office.

Early in 2001, President Bush directed the NIH not to fund any project pursuant to President Clinton's policy; later that year he decided funding for ESC research would be limited to projects using the approximately 60 then-extant cell lines derived from “embryos that ha[d] already been destroyed.” See 37 Weekly Comp. Pres. Doc.. 1149, 1151 (Aug. 9, 2001); see also Exec. Order No. 13,435, 72 Fed.Reg. 34,591 (2007); Doe v. Obama, 631 F.3d 157, 159 (4th Cir.2011). Meanwhile, the Congress continued to reenact Dickey–Wicker each year of the Bush Administration.

Upon assuming office in 2009, President Obama lifted the temporal restriction imposed by President Bush and permitted the NIH to “support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law.” Exec. Order 13,505, 74 Fed.Reg. 10,667, 10,667 (2009). The NIH, after notice-and-comment rulemaking, then issued the 2009 Guidelines, 74 Fed.Reg. 32,170–32,175 (July 7, 2009), which are currently in effect. In the Guidelines, the NIH noted “funding of the derivation of stem cells from human embryos is prohibited by ... the Dickey–Wicker Amendment.” Id. at 32,175/2. The Guidelines further addressed Dickey–Wicker as follows:

Since 1999, the Department of Health and Human Services (HHS) has consistently interpreted [Dickey–Wicker] as not applicable to research using [ESCs], because [ESCs] are not embryos as defined by Section 509. This longstanding interpretation has been left unchanged by Congress, which has annually reenacted the Dickey [sic] Amendment with full knowledge that HHS has been funding [ESC] research since 2001. These guidelines therefore recognize the distinction, accepted by Congress, between the derivation of stem cells from an embryo that results in the embryo's destruction, for which Federal funding is prohibited, and research involving [ESCs] that does not involve an embryo nor result in an embryo's destruction, for which Federal funding is permitted.

Id. at 32,173/2.

In place of President Bush's temporal limitation, the 2009 Guidelines instituted specific ethical restrictions upon ESC research funded by the NIH: Such research may be conducted only upon stem cell lines derived from embryos that “were created using in vitro fertilization for reproductive purposes and were no longer needed for this purpose,” and that “were donated by individuals who sought reproductive treatment ... who gave voluntary written consent for the human embryos to be used for research purposes,” and who were not paid therefor. Id. at 32,174/2–3. Moreover, the research may use stem cell lines derived from an embryo donated after the effective date of the Guidelines only if the in vitro clinic had fully informed the donor of all possible options for disposing of the embryo and had taken other specified procedural steps to separate reproductive treatment from donation. Id.

After the 2009 Guidelines were issued, the Congress once again reenacted Dickey–Wicker as part of the appropriations bill for fiscal year 2010. The Congress has not enacted an appropriations bill for FY 2011, adopting instead a series of continuing resolutions that have carried Dickey–Wicker forward to the present. Neither party to this case has suggested the Congress might modify Dickey–Wicker for the remainder of FY 2011.

Drs. Sherley and Deisher and a number of others filed this suit in August 2009 and moved the district court for a preliminary injunction. Instead, the district court granted the Government's motion to dismiss the suit for want of standing. The plaintiffs appealed and we reversed in part, holding the doctors alone had standing because th...