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Dr. James L. Sherley, et al v. Kathleen Sebelius

July 27, 2011

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

Two scientists brought this lawsuit, asking this Court to find that the National Institutes of Health Guidelines for Human Stem Cell Research ("Guidelines") are invalid as a matter of law. The Court's initial dismissal of plaintiffs' case for lack of standing was reversed on appeal, and plaintiffs' Motion for Preliminary Injunction was reinstated. The Court promptly granted plaintiffs' Motion for Preliminary Injunction, but was again reversed on appeal, and the Court must now determine the merits of the case. Before the Court are plaintiffs' Motion for Summary Judgment, Pls.' Mot. Summ. J. [55], and defendants' Motion for Summary Judgment. Defs.' Mot. Summ. J. [58]. Having carefully considered the motions, oppositions, replies, supplemental briefing, the entire record in this case, and the applicable law, the Court will grant defendants' Motion for Summary Judgment and deny plaintiffs' Motion for Summary Judgment. A review of the background of the case, the governing law, the parties' arguments, and the Court's reasoning in resolving those arguments follows.

II.Background

The human body comprises over 200 different cell types-muscle cells, skin cells, nerve cells, and so on-that perform all of its particular functions. AR at 588. These specialized cells, however, are all the descendants of a pool of unspecialized cells in the early human embryo, which divide, grow, and transform into all of the body's cells in a manner whose orderliness and complexity boggles the mind. Id. This case involves those unspecialized cells, called "embryonic stem cells," which can be transformed into any one of the hundreds of cell types found in the human body.

Embryonic stem cells are one of three types of human stem cells, with the other two being adult and induced pluripotent*fn1 stem cells. Embryonic stem cells are found in human embryos, and are made available for scientific research by a process-called "derivation"-that destroys the embryo. Once embryonic stem cells are derived, they can be used to create "lines" of stem cells that replicate indefinitely and provide a constant source of cells for research purposes. AR at 704. A second type of stem cell-adult stem cells-are, unlike embryonic stem cells, "limited to producing only certain types of specialized cells," and "are found in certain tissues in fully developed humans, from babies to adults." AR at 589. The third type of stem cell-induced pluripotent stem cells-are mature cells that have been "reprogrammed" using viruses so that their development reverses course, returning them to a condition similar to that of embryonic stem cells. AR at 718. Like embryonic stem cells, induced pluripotent stem cells can transform into hundreds of specialized human cells, although just how similar induced pluripotent stem cells are to embryonic stem cells remains unknown. Id.

Scientific interest in stem cells is driven by the recognition that, because they can be coaxed into forming particular body tissues, they hold the potential to advance medical science dramatically. AR at 587. Scientists hope to develop treatments for numerous diseases and conditions that continue to plague human beings-such as cancer, diabetes, and cardiovascular disease-by using stem cells to replace or rebuild damaged cells and tissues. Id. Since adult stem cells were first discovered in the 1950s, scientists have achieved success using such cells to develop treatments for human disease. AR at 593. But embryonic and induced pluripotent stem cells have only been available for scientific study since 1998, AR at 693, and so proven and safe therapeutic options involving these cell types are likely to require substantial additional research and time. AR at 600. Given the differences between the various stem cell types and their advantages and disadvantages as sources of potential therapies, the National Institutes of Health ("NIH") "believes that it is important to simultaneously pursue all lines of research." AR at 705.

Controversy has surrounded embryonic stem cell research since 1998, when scientists first succeeded in isolating and culturing stem cells from human embryos. In 1999, the NIH, finding that embryonic stem cells were "enormously important to science" and held "great promise for advances in health care," requested public comment on draft guidelines for funding embryonic stem cell research "in an ethical and legal manner." Draft National Institutes of Health Guidelines for Research Involving Human Pluripotent Stem Cells, 64 Fed. Reg. 67,576, 67,576 (proposed Dec. 2, 1999). The NIH recognized that the establishment of stem cell lines from embryos had "generated much interest among scientists and the public, particularly among patients and their advocates, especially with regard to the ethical issues related to this research." Id.

Funding embryonic stem cell research with taxpayers' dollars raised legal issues as well. Federal funding potentially conflicted with a Congressional law, first enacted in 1996, known as the "Dickey-Wicker Amendment." That Amendment, reenacted every year since 1996 without alteration, 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 CFR 46.204(b) and section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)).

Consolidated Appropriations Act, 2010, Pub. L. 111-117, § 509(a), 123 Stat. 3034, 3280--81 (2009). The Dickey-Wicker Amendment defines "embryo" as "any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells." Id. at § 509(b).

Aware of possible conflict between the NIH's plan to fund embryonic stem cell research and the Dickey-Wicker Amendment, the Director of the NIH requested a legal opinion in 1998 from the Office of the General Counsel of the Department of Health and Human Services ("HHS") on "whether NIH funds may be used for research using human pluripotent stem cells."*fn2

64 Fed. Reg. at 67,576. The NIH received that opinion in January 1999, in the form of a memorandum from government attorney Harriet S. Rabb. AR at 311. Ms. Rabb concluded that the NIH could legally fund embryonic stem cell research. Id. She wrote that although the Dickey-Wicker Amendment prohibited funding for research involving embryos, embryonic stem cells "are not a human embryo" as defined by the Amendment. Id. Ms. Rabb noted that the Dickey-Wicker Amendment defined an "embryo" as an "organism," and that scientific understanding recognized a distinction between the basic units of living creatures, such as stem cells, that cannot exist independently of the body for long, and organisms themselves, which perform on their own all of the life functions that allow them to grow and reproduce. AR at 312--13. She determined that stem cells "are not even precursors to human organisms," because stem cells can only develop into different cell types within the human body, while embryos can potentially develop into human organisms. Id. Based on Ms. Rabb's legal advice, the Director of the NIH convened a Working Group of the Advisory Committee to the Director to develop "appropriate guidelines governing . . . research involving the use of pluripotent stem cells derived from early human embryos in excess of clinical need." 64 Fed. Reg. at 67,577.

The guidelines were published in August 2000. National Institutes of Health Guidelines for Research Using Human Pluripotent Stem Cells, 65 Fed. Reg. 51,976, 51,976 (Aug. 25, 2000). The NIH had received about 50,000 public comments from "members of Congress, patient advocacy groups, scientific societies, religious organizations, and private citizens" in response to its guidelines. Id. Some commenters argued that the guidelines conflicted with the Dickey-Wicker Amendment; that they were too restrictive; that they were unnecessary; or that research on human embryonic stem cells was itself unnecessary because adult stem cells were satisfactory substitutes. Id. In response to commenters who questioned the NIH's decision to fund embryonic stem cell research in addition to adult stem cell research, the NIH concluded that "it is important to simultaneously pursue all lines of promising research," and presented a number of differences between adult and embryonic stem cells that warranted research on the latter. Id. The final guidelines required applicants for NIH grants to provide assurance that the stem cells used in the research were derived from only certain human embryos. Id. at 51,979. Embryos slated for derivation had to be "created for the purposes of fertility treatment" and "in excess of the clinical need of the individuals seeking such treatment." Id. Various other conditions in the guidelines were designed to ensure that the embryo donor's consent was voluntary and informed. Id. at 51,979--80.

A change in Presidential administrations resulted in a significant change to federal stem cell policy. In August 2001, President George W. Bush stated in an evening address to the nation that "[e]mbryonic stem cell research offers both great promise and great peril." Address to the Nation on Stem Cell Research from Crawford, Texas, 37 Weekly Comp. Pres. Doc. 1149 (Aug. 13, 2001), AR at 21. He recognized that this research "could help improve the lives of those who suffer from many terrible diseases." Id., AR at 19. He noted that the United States has a long history of advancing science and medicine, as well as a "proud record of upholding the highest standards of ethics" while expanding science's limits. Id. Embryonic stem cell research, President Bush stated, "raises profound ethical questions" because the derivation process destroys the embryo from which stem cells are derived, therefore "destroy[ing] its potential for life." Id. "Like a snowflake, each of these embryos is unique, with the unique genetic potential of an individual human being." Id.

Torn between his confidence in the healing power of science and his belief that "human life is a sacred gift from our Creator," President Bush made what many have called a "Solomonic" decision: to permit federal funding for embryonic stem cell research, but only for such research as involved stem cells derived from embryos that had already been destroyed, where "the life and death decision has already been made." Id.,AR at 21. Like the previous administration, President Bush refused to impose a categorical ban on embryonic stem cell research, but he substituted a temporal limitation in the place of the embryo-source and informed consent limitations reflected in the NIH's then-current guidelines. Federal funding was available only for embryonic stem cell research using stem cells derived from embryos that were destroyed before August 9, 2001-the date of President Bush's address to the nation. Id.

Since President Bush's policy continued to permit some federal funding for embryonic stem cell research, once again there were questions concerning whether even that, more restrictive, policy complied with the Dickey-Wicker Amendment. Dr. Ruth Kirchstein, then Acting Director of the NIH, received a legal opinion on the issue in January 2002 from HHS General Counsel Alex M. Azar II. AR at 303. Mr. Azar concluded that President Bush's policy was consistent with the plain language of the Dickey-Wicker Amendment. AR at 306. He looked to the ordinary and common meaning of the phrase "research in which" used in the text of the Amendment. Id. Mr. Azar cited to a dictionary that defined "in" as meaning "within the confines of; inside"; "within the area covered by"; "during the course of or before the expiration of"; "during or part of the act or process of"; "within the category or class of." AR at 307. He did not specifically define the term "research." Mr. Azar concluded that since President Bush's policy would provide federal funding only for stem cell lines created before his August 9, 2001 address and because it "provides no incentive for the destruction of additional embryos," the policy "does not provide federal funding for 'research in which [during the course of, during or part of the act or process of, or within the category or class of] embryos are destroyed, discarded, or knowingly subjected to risk of injury or death . . . .'" Id.

The winds of Federal stem cell policy shifted again in 2008, with the election of Barack Obama as President. In March 2009, President Obama issued an Executive Order nullifying former President Bush's stem cell policy. Exec. Order No. 13,505, 74 Fed. Reg. 10,667, 10,667 (Mar. 11, 2009), AR at 12. The Order's purpose was to remove President Bush's limitations on the NIH's ability to fund and conduct human embryonic stem cell research, thereby "enhanc[ing] the contribution of America's scientists to important new discoveries and new therapies for the benefit of humankind." Id. President Obama authorized 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." Id. He directed the NIH to publish new guidelines on human stem cell research consistent with his Order within 120 days. Id.

Several weeks later, the NIH requested public comment on draft guidelines. Draft National Institutes of Health Guidelines for Human Stem Cell Research Notice, 74 Fed. Reg. 18,578, 18,578 (proposed Apr. 23, 2009). The NIH stated that the purpose of the draft guidelines was to implement President Obama's Executive Order, "to establish policy and procedures under which NIH will fund research in this area, and to help ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law." Id. The proposed guidelines would permit funding for embryonic stem cell research using stem cells derived from embryos created for reproductive purposes and no longer needed for that purpose. Id. They also contained provisions ensuring that research funds would only go to research projects using stem cells that were derived from embryos that had been donated with the informed consent of the donor. Id. at 18,579. As such, these proposed guidelines represented a return to the policy and funding approach that existed before President Bush's administration.

The NIH, as it had back in 2000, received nearly 50,000 comments in response to its draft guidelines. National Institutes of Health Guidelines for Human Stem Cell Research, 74 Fed. Reg. 32,170, 32,170 (July 7, 2009). In its final Guidelines, the NIH responded to certain categories of public comments that it had received, including comments indicating that the informed consent procedures set out in the draft guidelines were duplicative with existing procedures or too cumbersome, that the allowable sources of embryonic stem cells should be expanded to embryos created solely for research purposes, and that the NIH's mechanisms for ensuring ongoing compliance with the guidelines were lacking. Id. at 32,171--74.

In the course of responding to comments seeking clarification of its statement in the draft guidelines that embryonic stem cells "are not themselves human embryos," 74 Fed. Reg. at 18,578, the NIH presented its longstanding interpretation of the Dickey-Wicker Amendment as not prohibiting federal funding for embryonic stem cell research because human embryonic stem cells "are not embryos" as defined by the Amendment. 74 Fed. Reg. at 32,173. The NIH stated further that 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 [human embryonic stem cells] that does not involve an embryo nor result in an embryo's destruction, for which Federal funding is permitted." Id.

The NIH also received numerous comments objecting to any federal funding whatsoever for embryonic stem cell research. See e.g., AR at 2644. Commenters sought a categorical ban on embryonic stem cell research either for ethical or scientific reasons, or both. The NIH did not respond to such comments, believing them to be outside the scope of the rulemaking. Defs.' Mot. Summ. J. [58] 37. The NIH made minor revisions to the draft guidelines in response to certain comments, and then published the final Guidelines, with an effective date of July 7, 2009. Id. at 32,170.

A legal challenge to the Guidelines came swiftly. In August 2009, a group of plaintiffs, including Drs. James L. Sherley and Theresa Deisher-both of whom are scientists performing research involving adult stem cells-filed a lawsuit in this Court against various defendants, including the National Institutes of Health. Plaintiffs claimed that the Guidelines violated the Dickey-Wicker Amendment and were promulgated in violation of the Administrative Procedure Act. Compl. [1] ¶1, 2. They sought declarations that the Guidelines are not in accordance with law, were promulgated without the observance of required procedures, are arbitrary and capricious, and that past acts by the NIH pursuant to the Guidelines, including previous decisions to fund embryonic stem cell research projects, are null and void. Id. at ¶79. They also sought to enjoin defendants from taking any future actions of any kind pursuant to the Guidelines or otherwise funding embryonic stem cell research. Id. That same day, they filed a Motion for Preliminary Injunction seeking an immediate cessation of actions taken pursuant to the Guidelines. Pls.' Mot. Prelim. Inj. [3] 1.

Defendants filed a Motion to Dismiss, arguing that plaintiffs lacked standing under Article III of the Constitution and that they had failed to state a claim for which relief could be granted. Defs.' Mot. Dismiss [22] 2. This Court granted defendants' motion, concluding that no plaintiff met all of the requirements of standing and that therefore the Court lacked subject matter jurisdiction over the lawsuit. Sherley v. Sebelius, 686 F. Supp. 2d 1, 3 (D.D.C. 2009). With respect to Drs. Sherley and Deisher, the Court noted that they had alleged in their Complaint that the Guidelines had increased competition for limited NIH funds and would therefore make it more difficult for them to compete successfully for those funds. Id. at 6. The Court found, however, that mere "increased competition for funding is an insufficient injury to impart standing." Id.

Plaintiffs appealed, challenging only this Court's determination that Drs. Sherley and Deisher lacked standing. The Court of Appeals for the District of Columbia reversed, finding that both Dr. Sherley and Dr. Deisher had standing. Sherley v. Sebelius, 610 F.3d 69, 70 (D.C. Cir. 2010). It held that Drs. Sherley and Deisher suffered an "actual, here-and-now injury" because "the Guidelines have intensified the competition for a share in a fixed amount of money," with the result that "plaintiffs will have to invest more time and resources to craft a successful grant application." Id. at 74. The Court reversed this Court's Order dismissing plaintiffs' claims while also reinstating plaintiffs' Motion for Preliminary Injunction. Id. at 75.

With plaintiffs' Motion for Preliminary Injunction ripe for decision, this Court promptly ruled and found that "the likelihood of success on the merits, irreparable harm to plaintiffs, the balance of the hardships, and public interest considerations each weigh in favor of a preliminary injunction." Sherley v. Sebelius, 704 F. Supp. 2d 63, 70 (D.D.C. 2010). In particular, this Court concluded that the Guidelines violated the Dickey-Wicker Amendment's prohibition on federal funding for "research in which a human embryo or embryos are destroyed." Id. at 70 (quoting Omnibus Appropriations Act 2009, Pub. L. No. 111-8, § 509(a)(2), 123 Stat. 524, 803 (2009)). This Court determined that the term "research" had "only one meaning, i.e., 'a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.'" Id. (quoting 45 C.F.R. § 46.102(d)). Rejecting defendants' argument that "research" meant "a piece of research," this Court found that the Dickey-Wicker Amendment's prohibition "encompasses all 'research in which' an embryo is destroyed, not just the 'piece of research' in which the embryo is destroyed." Id. at 71. After concluding that embryonic stem cell research is research in which an embryo is destroyed according to the Dickey-Wicker Amendment, this Court held that the Guidelines violated that Amendment and that plaintiffs had shown a strong likelihood of success on the merits. Id. at 71--72. This Court applied the other preliminary injunction factors, found them to be satisfied, and granted plaintiffs' motion. Id. at 73.

Defendants sought and received a stay of this Court's injunction from the D.C. Circuit, which later vacated the injunction on appeal. Sherley v. Sebelius, No. 10-5287, 2011 WL 1599685, at *1 (D.C. Cir. Apr. 29, 2011). Contrary to this Court's conclusion, the Court of Appeals held that "plaintiffs are unlikely to prevail [on the merits] 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 [embryonic stem cell] from an embryo, it does not prohibit funding a research project in which an [embryonic stem cell] will be used." Id. The Court determined that the meaning of the word "research" is "flexible enough to describe either a discrete project or an extended process." Id. at *6.

Having determined the statute to be ambiguous, the Court of Appeals proceeded to step two of the framework set out in Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984), which requires judicial deference to an agency interpretation of an ambiguous statute so long as it reflects a "permissible construction of the statute." 467 U.S. at 842--43. While noting that defendants had not defined "research" in so many words, the Court rejected plaintiffs' contention that defendants had not offered an interpretation warranting judicial deference by concluding that NIH's use of the term "research" implicitly gave it a narrow scope. Sherley, 2011 WL 1599685, at *6. After concluding that the NIH's implicit interpretation was reasonable, id. at *7--8, the Court held that plaintiffs had failed to show that they were likely to succeed on the merits and that the other preliminary injunction factors weighed against the award of a preliminary injunction. Id. at *10.

With the preliminary injunction order vacated by the Court of Appeals, the lawsuit returned to this Court for review of the parties' ...


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