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Sherley v. Sebelius

June 25, 2010


Appeal from the United States District Court for the District of Columbia (No. 1:09-cv-01575-RCL).

The opinion of the court was delivered by: Ginsburg, Circuit Judge

Argued April 12, 2010

Before: GINSBURG, BROWN, and KAVANAUGH, Circuit Judges.

An array of variously situated plaintiffs sued the Department and the Secretary of Health and Human Services and the National Institutes of Health and its Director, challenging newly promulgated guidelines that authorize the NIH to fund more research projects involving human embryonic stem cells than it had previously done. The district court dismissed the suit for want of a plaintiff with standing and dismissed as moot the plaintiffs' motion for a preliminary injunction. All the plaintiffs appeal those rulings, but they defend the standing of only two of their number, Drs. James Sherley and Theresa Deisher.

We conclude the two Doctors have standing. Therefore, we reverse the order of the district court insofar as it dismissed their claims and we reinstate the motion for a preliminary injunction.

I. Background

Because a stem cell can develop into any one of many specialized cells in the human body, it can be used in the treatment of a variety of diseases. There are two basic kinds of mammalian stem cells relevant to this case: embryonic stem cells (ESCs), which are found in human embryos, and adult stem cells (ASCs), which are found in the human body and in tissues discarded after birth.

Scientists, often with financial support from the NIH, have done research involving ASCs for about 50 years. They have done research involving ESCs only since 1998, and the NIH did not fund such research until 2001, when President Bush authorized it to do so subject to the limitation that only ESCs derived from then-extant stem cell lines be used.

In 2009 President Obama removed that limitation, directing the "Secretary of Health and Human Services ... through the Director of NIH, [to] support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law" and to "issue new NIH guidance on such research that is consistent with this order." Exec. Order No. 13,505, 74 Fed. Reg. 10,667, 10,667 (Mar. 9, 2009). Pursuant to the resulting Guidelines for Human Stem Cell Research, 74 Fed. Reg. 32170 (July 7, 2009), the NIH may now fund more projects involving ESCs than was previously possible.

The plaintiffs alleged the issuance of the Guidelines violated the Administrative Procedure Act because, among other reasons, the "promulgation and implementation of the Guidelines are not in accordance with law," Compl. ¶ 67; see 5 U.S.C. § 706(2)(A), to wit, the Dickey-Wicker Amendment, which the Congress has attached every year since 1996 to the Acts appropriating money for the DHHS and which prohibits federal funding of research in which a human embryo is to be harmed or destroyed, e.g., Omnibus Appropriations Act of 2009, Pub. L. No. 111-8, div. F, Title V, § 509(a)(2), 123 Stat. 524. The defendants moved to dismiss the case on the ground that none of the plaintiffs had standing to challenge the issuance of the Guidelines. Sherley v. Sebelius, 686 F. Supp. 2d 1 (D.D.C. 2009). The plaintiffs whose standing is at issue here are Drs. Sherley and Deisher, both of whom "specialize in adult stem cell research" and who, respectively, have received and plan to seek NIH grants for research involving ASCs. Id. at 3.

They claimed to have "competitor standing" because the Guidelines would "result in increased competition for limited federal funding and [would] thereby injure [their] ability to successfully compete for ... NIH stem cell research funds." Id. at 4. The district court rejected that contention. First, relying upon Hardin v. Kentucky Utilities Co., 390 U.S. 1, 6 (1968), the court reasoned that a party may assert competitor standing only when the "particular statutory provision ... invoked" reflects a purpose "to protect a competitive interest" and that the Doctors had not shown they had a protected interest in receiving research funds from the NIH. Sherley, 686 F. Supp. 2d at 6. The court further concluded the cases upon which the Doctors relied established only that competitor standing applies to participants in "strictly regulated economic markets," whereas the Doctors were "applicants for research grants." Id. at 7. Finally, the court opined that even if the Doctors qualify as "competitors," they would still lack standing because the "application process to receive NIH funding is [already] extremely competitive," id., i.e., the additional competition made possible by the Guidelines would "not 'almost surely cause [them] to lose' funding," id. (quoting El Paso Natural Gas Co. v. FERC, 50 F.3d 23, 27 (D.C. Cir. 1995)).

The district court also held none of the other plaintiffs had standing. On appeal, those plaintiffs make no argument to the contrary, wherefore we take their lack of standing as conceded. See, e.g., Sitka Sound Seafoods, Inc. v. NLRB, 206 F.3d 1175, 1181 (D.C. Cir. 2000) (argument not raised in opening brief on appeal is forfeited).

II. Analysis

In reviewing de novo the district court's decision to dismiss this suit on the ground that the Doctors lack standing to sue, Young Am.'s Found. v. Gates, 573 F.3d 797, 799 (D.C. Cir. 2009), we "accept[] as true all of the factual allegations contained in the complaint and draw[] all inferences in favor of the nonmoving party," City of Harper Woods Employees' Ret. Sys. v. Olver, 589 F.3d 1292, 1298 (D.C. Cir. 2009). The Doctors' burden is to show they have standing not only under Article III of the ...

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