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Sherley v. Sebelius

August 23, 2010

DR. JAMES L. SHERLEY, ET AL., PLAINTIFFS,
v.
KATHLEEN SEBELIUS, ET AL., DEFENDANTS.



The opinion of the court was delivered by: Royce C. Lamberth, Chief Judge

MEMORANDUM OPINION

I. INTRODUCTION

This matter comes before the Court on plaintiffs' Motion [3] for a Preliminary Injunction. Previously, this Court dismissed this case for lack of standing and denied plaintiffs' motion for a preliminary injunction as moot. Plaintiffs appealed. On appeal, plaintiffs argued that plaintiffs Drs. Sherely and Diesher had competitor standing and conceded that other plaintiffs lacked standing. The Court of Appeals reversed, holding that plaintiffs Sherley and Diesher have standing, and remanded the matter to this Court for consideration of plaintiffs' motion for a preliminary injunction. The mandate from the Court of Appeals was filed in this Court this date.

For the reasons set forth below, the Court will GRANT plaintiffs' motion and issue a preliminary injunction.

II. BACKGROUND

A. Procedural History

Plaintiffs Drs. James L. Sherley and Theresa Deisher, Nightlight Christian Adoptions ("Nightlight"), Embryos, Shayne and Tina Nelson, William and Patricia Flynn, and Christian Medical Association ("CMA") brought this suit for declaratory and injunctive relief to prevent defendants' Guidelines for Human Stem Cell Research ("Guidelines") from taking effect. (Compl.¶¶ 4, 6-12.) Specifically, plaintiffs sought "an order (a) declaring that the Guidelines are contrary to law, were promulgated without observing the procedures required by law, and constitute arbitrary and capricious agency action; and (b) enjoining [d]efendants from applying the Guidelines or otherwise funding research involving the destruction of human embryonic stem cells." (Id. ¶ 4.) On October 27, 2009, this Court dismissed plaintiffs' suit, finding that plaintiffs lacked standing, and denied plaintiffs' motion for a preliminary injunction as moot. Sherley v. Sebelius, 686 F. Supp. 2d 1, 5-7 (D.D.C. 2009). Plaintiffs appealed.

The Court of Appeals reversed, concluding that Drs. Sherley and Deisher had standing under the competitor standing doctrine. Sherely v. Sebelius, -- F.3d --, 2010 WL 2540358, *5 (D.C. Cir. 2010). Because the Nightlight, the Embryos, the Nelsons, the Flynns, and CMA did not contest this Court's finding that they lacked standing, the Court of Appeals treated "their lack of standing as conceded." Id. at *2. The Court of Appeals then remanded this matter back to this Court for consideration of plaintiffs' motion for a preliminary injunction. Id. at *6.

B. Stem Cell Research

Stem cell research has the potential to produce medical breakthroughs in the treatment of many life-threatening diseases and conditions that have resisted traditional methods of treatment. (Pls.' Mot. [3] for Prelim. Inj. at 2; Defs.' Opp'n [22] at 2.) There are three types of stem cells available for research: adult stem cells ("ASCs"), induced pluripotent stem cells ("IPSCs"), and human embryonic stem cells ("ESCs"). (Pls.' Mot. [3] for Prelim. Inj. at 2.) Each type of stem cell possesses unique capabilities and limitations. (Def.'s Opp'n [22] at 3.) As a result, many scientists believe that research should be conducted on each type of stem cell. (Id. (citing Nat'l Insts. of Health, Stem Cell Information: Frequently Asked Questions, http://stemcells.nih.gov/info/faqs.asp).) Other scientists, however, believe that research should be conducted only on ASCs and IPSCs because ESC research has not produced positive results and is morally objectionable. (Pls.' Mot. [3] for Prelim. Inj. at 2-3.)

ESCs have been available for research since 1998, when Dr. James Thomson of the University of Wisconsin discovered a process for deriving stem cells from an embryo. (Id. at 3.) ESCs are pluripotent, i.e, they have "the capability to give rise to any of the approximately 200 types of cells in the human body." (Def.'s Opp'n [22] at 3.) Once they are derived from an embryo, ESCs may be maintained indefinitely. See Nat'l Insts. of Health, Stem Cell Information: Frequently Asked Questions, http://stemcells.nih.gov/info/faqs.asp.

ESCs may be used to treat diseases in two ways. First, researchers can transplant ESCs into patients. (See Defs.' Opp'n [22] at 3.) To transplant ESCs, researchers must guide the differentiation of ECSs into certain kinds of cells. (Id.) Differentiation of ESCs reduces the risk of benign tumor forming after the ESCs are transplanted. (Id. (citing Nat'l Acads., Understanding Stem Cells: An Overview of the Science and the Issues from the National Academies at 5 (2009)).) Second, ESCs may be used to "study disease mechanisms that cannot be studied in the human body, and to develop other, non-stem-cell based therapies for these conditions." (Defs.' Opp'n [22] at 4.) Recent studies employing both methods of treatment suggest that ESCs will contribute to the development of medical knowledge in the future. (See id.)

ASC research, in which Drs. Sherley and Deisher specialize, is approximately fifty years old and began with the discovery of hematopoietic stem cells. (Id.) ASCs are found in tissues that are normally discarded after birth, such as the umbilical cord, and in the body. (Pls.' Mot.

[3] for Prelim. Inj. at 3.) Because researchers have been able to study ASCs for decades, they have been able to develop treatments for numerous diseases with ASCs. (Id.; Defs.' Opp'n [22] at 5.) ASCs, however, are limited because, unlike ESCs, they are multipotent, not pluripotent. (Defs.' Opp'n [22] at 5 (citing Nat'l Insts. of Health, Hematopoietic Stem Cells, http://stemcells.nih.gov/info/scireport/chapter5.asp).) As a result, ASCs cannot differentiate into the 200 types of cells in the human body. (Id.) Nevertheless, ASC research remains of great importance in the treatment of disease. (Id. at 6.)

IPSC research is the newest form of stem cell research. Discovered in 2007, IPSCs "are adult stem cells that have been genetically reprogrammed such that they are virtually identical to embryonic stem cells." (Pls.' Mot. [3] for Prelim. Inj. at 4.) Because research involving IPSCs is at such an early stage, its full potential is unknown. (Defs.' Opp'n [22] at 5.) Some researchers, however, believe that IPSCs offers the most promise for advancements in medical research and treatment. (Pls.' Mot. [3] for Prelim. Inj. at 4-5.)

C. Regulatory Background

In 1996, Congress enacted the Balanced Budget Downpayment Act, Pub. L. No. 104-99, ยง 128, 110 Stat. 26, 34 (1996). The Balanced Budget Downpayment Act contained a rider, known as the Dickey-Wicker Amendment, which prohibited the use of federal funds for "(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 ...


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