IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA

________________________________________________
)
DR. JAMES THOMSON, Assistant Professor, The 		)
Wisconsin Regional Primate Research Center, The 		)
University of Wisconsin-Madison, 1220 Capitol Court, 	)
Madison, WI  53715-1299; DR. ROGER PEDERSEN, 	)
Professor and Research Director, Department of 		)
Obstetrics, Gynecology and Reproductive Sciences, 		)
University of California, San Francisco, 533 Parnassus 	)
Avenue, San Francisco, CA  94143-0720; 			)	Civil Action No. __________
DR. JOHN GEARHART, C. Michael Armstrong 		)
Professor, The Johns Hopkins University, Gynecology 	)
and Obstetrics,  Park Building, 600 North Wolfe 		)
Street, Baltimore, MD  21287; DR. DOUGLAS 		)	COMPLAINT FOR
MELTON, Cabot Professor and Chairman of the		) 	DECLARATORY AND
Department of Molecular and Cellular Biology, 		)	INJUNCTIVE RELIEF
Harvard University, 7 Divinity Avenue,			)
Cambridge, MA  02138; DR. DAN KAUFMAN, 		)
Fellow, Department of Internal Medicine/Hematology,	)
University of Wisconsin Hospital and Clinics,			)
600 Highland Avenue, Madison, WI  53792; 			)
DR. ALAN OSBORNE TROUNSON, Institute of 		)
Reproduction and Development, Monash Medical Centre,	)
246 Clayton Road, Clayton Victoria 3168, Australia;		)
DR. MARTIN PERA, Associate Professor and 		)
Deputy Director, Center for Early Human Development, 	)
Institute of Reproduction and Development,			)
Monash Medical Centre, 246 Clayton Road, 			)
Clayton Victoria 3168, Australia;				)
CHRISTOPHER REEVE, Chairman of the Board, 		)
Christopher Reeve Paralysis Foundation, 			)
500 Morris Avenue, Springfield, NJ  07081; 			)
JAMES CORDY, 6470 Monitor Street, 			)
Pittsburgh, PA 15217; 					)
JAMES TYREE, 1254 N. Lake Shore Drive,			)
Chicago, IL  60610,						)
)
Plaintiffs,		)
v. 					)
)
TOMMY G. THOMPSON, in his official capacity as	)
Secretary of the Department of Health and Human		)
Services, 200 Independence Avenue, S.W.,			)

Washington, D.C. 20201; DEPARTMENT OF		)
HEALTH AND HUMAN SERVICES, 200			)
Independence Avenue, S.W., Washington, D.C. 20201;	)
DR. RUTH KIRSCHSTEIN, in her official capacity as	)
Acting Director of the National Institutes of Health,		)
9000 Rockville Pike, Bethesda, MD 20892;			)
NATIONAL INSTITUTES OF HEALTH, 9000		)
Rockville Pike, Bethesda, MD 20892,			)
)
Defendants.		)
________________________________________________)

	COMPLAINT FOR DECLARATORY
	AND INJUNCTIVE RELIEF

I.
Introduction
1.	This action is brought by a group of researchers and patients who are being irreparably harmed by the failure of defendants to implement the NIH Guidelines for Research Using Human Pluripotent Stem Cells (hereinafter the Guidelines).  This failure to implement the Guidelines violates the National Institutes of Health Revitalization Act of 1993, which prohibits the executive branch from withholding funding for human pluripotent stem cell research, and contravenes the defendants= statutory duty to fund scientifically meritorious research projects.  Plaintiffs therefore seek declaratory and injunctive relief requiring defendants to proceed forthwith to implement the Guidelines and fund research using human pluripotent stem cells, which, as defendants themselves have recognized, Aare a unique scientific and medical resource@ and Ahold great promise for both research and health care.@  

II.
Human Pluripotent Stem Cells
2.	This case involves human pluripotent stem cells (AHPSCs@), which are cells that have the ability to divide for indefinite periods in culture and to give rise to other kinds of specialized cells.  Pluripotent stem cells form in the early stages of normal human development.  When a sperm fertilizes an egg, it creates a single cell that has the potential to form an entire human being.  The fertilized egg is referred to as Atotipotent@ since it has total potential.  It has this potential for approximately two days after fertilization.  Approximately three to four days after fertilization, these totipotent cells (which have been continually dividing) begin to specialize and form a hollow sphere of cells referred to as a blastocyst.  The blastocyst has an outer layer capable of forming the placenta and other supporting tissue in the woman=s uterus.  The inner cell mass B which is composed of pluripotent stem cells B can form virtually all the specialized cells of the human body but these pluripotent stem cells cannot by themselves form an organism.
3.	Human pluripotent stem cells may be derived from excess embryos donated by couples undergoing fertility treatments (these stem cells are referred to as embryonic stem cells) or from non-living fetuses obtained from terminated first trimester pregnancies (these stem cells are referred to as embryonic germ cells).
4.	In 1998, human pluripotent cell lines were derived using non-federal funds from blastocysts by Dr. James Thomson of the University of Wisconsin and from fetal tissue by Dr. John Gearhart of The Johns Hopkins University.  Both of these scientists are plaintiffs in this action.
1.	
5.	Science magazine declared stem cells the Abreakthrough science story@ of 1999, and NIH has referred to human pluripotent stem cells as Aa unique scientific and medical resource.@  The study of stem cells holds promise of revolutionizing  human medicine in at least three ways, as set forth in paragraphs 6-8 below.
6.	First, human pluripotent stem cells hold great promise as a source for transplantation therapies when well characterized homogenous human cell lines are developed and tested.  These cells can be used to replace missing, damaged or dying cells.  Recent studies in animals have shown that embryonic stem cells appear to be a very promising source for generating dopaminergic neurons and other needed cells for Parkinson=s Disease, insulin-producing islet cells for diabetes, and cardiac tissue for heart disease.  Other diseases or conditions for which stem cell technology holds promise include ALS, Down=s Syndrome, and spinal cord injury.
7.	Second, the study of normal and abnormal development during this phase may revolutionize our understanding of birth defects and cancer.  The least understood phase of human development is how the blastocyst differentiates into the more specialized cells that give rise to tissue and organs.  The discovery of the genetic and cellular events that drive these processes, and translating those discoveries into treatments that benefit human health, are likely to be very significant for human health.
8.	The third potentially revolutionary use of human pluripotent stem cells is as a tool in drug discovery.  Thus, drugs can be tested initially for safety and efficacy on target cells created from stem cells, with only the promising agents moving into more expensive animal studies and human clinical trials.
1.	
9.	Stem cells can also be found in adult tissue.  However, adult stem cells are multipotent, not pluripotent, which means their cells have limited potential compared to pluripotent stem cells derived from embryos or fetal tissue.  While research on adult stem cells is uncovering new insights, human adult stem cells have not yet been isolated for all cell and tissue types, and they have not been shown to be capable of developing into all of the different functional cell and tissue types of the body.  Furthermore, adult stem cells are often difficult to obtain, since they are often present in only minute quantities.  In addition, it has not been shown that adult stem cells can be grown in culture in adequate amounts to develop therapies.
10.	As 80 Nobel laureates who signed a February 22, 2001 letter to President Bush urging funding for research on human pluripotent stem cells correctly explained:  ASome have suggested that adult stem cells may be sufficient to pursue all treatments for human disease.  It is premature to conclude that adult stem cells have the same potential as embryonic stem cells B and that potential will almost certainly vary from disease to disease.  Current evidence indicates that adult stem cells have markedly restricted differentiation potential.  Therefore, for disorders that prove not to be treatable with adult stem cells, impeding human pluripotent stem cell research risks unnecessary delay for millions of patients who may die or endure needless suffering while the effectiveness of adult stem cells is evaluated.@
11.	Embryonic stem cells, embryonic germ cells, and human embryonic cell lines are not organisms.  If a clump of such cells was transferred to a woman=s uterus, the cells would not implant and form a fetus.

III.
The Need for Federal Funding of HPSC Research
12.	The availability to qualified scientists of shared, standard genetic data and other standard information and models has been indispensable to advancement of research in life sciences.  Public funding under federal auspices is the only effective way of making embryonic stem cell lines available broadly to the scientific community.
13.	To realize the potential health benefits of stem cell technology will require a sustained, substantial investment in research.  The federal government is the only realistic source for such an infusion of funds.  For example, to exploit the potential of HPSCs for Parkinson=s Disease will require many investigators from different disciplines to be brought together.  Experts in cell fate specification and stem cells are needed to study how a cell becomes a dopamine neuron as well as other cells, immunologists are needed to study how to prevent immunological rejection, cellular engineers are required to develop turn off switches, and experts in Parkinson=s Disease and other disorders are required to provide the models and expertise to apply the technology.  Experts in bioinformatics and computation biology are required to take advantage of the explosion in genomics.  Without federal funding, progress in this area will be substantially retarded.
1.	
14.	Ongoing research using HPSCs that is privately funded is not subject to the ethical and regulatory constraints imposed by the NIH Guidelines.  Federal funding for HPSC research is necessary to ensure enforcement of the Guidelines= provisions.  Oversight of federally-funded research would cover such issues as the source of cells, informed consent, and measures to ensure safety and the ethical use of HPSCs.	IV.
	Political And Legal Context
15.	There is a long tradition in biomedical research of utilizing fetal tissue to develop life saving techniques.  For example, the 1954 Nobel Prize for Medicine was awarded to American immunologists who developed the polio vaccine based on cultures of human fetal kidney cells.
16.	Research involving fetal tissue as a source for transplantation therapies was proposed for federal funding in the 1980=s, but the government did not fund such research until President Clinton took office in 1993.
17.	On March 22, 1988, the Assistant Secretary for Health of the Department of Health and Human Services (AHHS@) imposed a temporary moratorium on federal funding of research involving transplantation of fetal tissue.  On November 2, 1989, contrary to the recommendations of an NIH advisory panel, the Secretary of HHS extended the moratorium indefinitely.
18.	On May 21, 1992, President George H.W. Bush issued Executive Order 12806, which required HHS to establish a human fetal tissue bank, with such tissue to be obtained exclusively from ectopic pregnancies and spontaneous abortions.  57 Fed. Reg. 21589.
19.	On January 23, 1993, President Clinton issued a Memorandum to the Secretary of HHS, directing that the moratorium on federal funding of research involving transplantation of fetal tissue from induced abortions be lifted immediately.  48 Fed. Reg. 7457.
1.	
20.	The NIH Revitalization Act of 1993, Pub. L. No. 103-43, added statutory force to the nullification of the 1992 Executive Order and affirmatively prohibits the executive branch of government from interfering with research involving human fetal tissue.  Section 121(c) of the Act provided that A[t]he provisions of Executive Order 12806 . . . shall not have any legal effect.@  Section 113 of the Act, entitled ANullification of Moratorium,@ further provides prospective protection against a return to the moratorium:
A(a)  In general.  B  Except as provided in subsection (c), no official of the executive branch may impose a policy that the Department of Health and Human Services is prohibited from conducting or supporting any research on the transplantation of human fetal tissue for therapeutic purposes.  Such research shall be carried out in accordance with section 498A of the Public Health Service Act (as added by section 111 of this Act) [42 U.S.C. ' 289g-1], without regard to any such policy that may have been in effect prior to the date of the enactment of this Act [June 10, 1993].

A(b) Prohibition against withholding of funds in cases of technical and scientific 	        merit.  B 

    A(1)  In general.  B  Subject to subsection (b)(2) of section 492A of the Public Health Service Act (as added by section 101 of this Act) [42 U.S.C. ' 289a-1(b)(2)], in the case of any proposal for research on the transplantation of human fetal tissue for therapeutic purposes, the Secretary of Health and Human Services may not withhold funds for the research if B

   A(A)  the research has been approved for purposes of subsection (a) of such section 492A [section 289a1 of this title];

   A(B)  the research will be carried out in accordance with section 498A of such Act (as added by section 111 of this Act) [this section]; and

   A(C)  there are reasonable assurances that the research will not utilize any human fetal tissue that has been obtained in violation of section 498B(a) of such Act (as added by section 112 of this Act) [section 289g-2(a) of this title].

42 U.S.C.A. ' 289g-1 (Note), Pub. L. No. 103-43, Title I, ' 113.  The definition of fetal tissue as used in Section 113 includes human pluripotent stem cells derived from fetal or embryonic sources.
21.	Section 111 of the NIH Revitalization Act of 1993 also added a new statutory provision authorizing government funding of research on the transplantation of human fetal issue for therapeutic purposes.  See 42 U.S.C. ' 289g-1.  That provision states that NIH may Asupport research on the transplantation of human fetal tissue for therapeutic purposes@ and specifies certain safeguards to ensure that abortions are not thereby encouraged.  This authorization extends to research on transplantation involving human pluripotent stem cells derived from fetal or embryonic sources.  
22.	For each relevant part of the NIH Revitalization Act, the definition of Ahuman fetal tissue@ means Atissue or cells obtained from a dead human embryo or fetus after a spontaneous or induced abortion, or after a stillbirth.@  42 U.S.C. ' 289g-1(g).
23.	In 1995, Congress imposed a new ban on use of appropriated federal funds for the creation of human embryos or for research Ain which@ human embryos are destroyed, discarded or knowingly subjected to excess risk.  That limitation on federal funding of embryo creation or destruction has been repeated in each annual appropriations act.  The current limitation is found in ' 510 of the Consolidated Appropriations Act, 2001, Pub. L. No. 106-554.
24.	The federal government has studied the ethical and legal issues involved in HPSC research at length.  On January 15, 1999, the General Counsel of HHS provided a written opinion concluding that federal funding involving research using stem cells derived from embryos is lawful, so long as private funds were used to derive the cells from the embryos. 
1.	
25.	The NIH then began a notice and comment procedure to develop guidelines for such research.  Draft guidelines were published in the Federal Register on December 2, 1999.  The final NIH Guidelines for Research Using Human Pluripotent Stem Cells were published in the Federal Register on August 25, 2000.  The Guidelines provide, among other things, that NIH funds may be used for research using HPSCs after such cells have been derived from embryos, but such funds may not be used in connection with the process of deriving the stem cells from the embryos themselves.  With respect to fetal tissue, the Guidelines allow funding of research to derive pluripotent stem cells from fetal tissue, as well as for research using such cells, in accordance with the provisions of 42 U.S.C. ' 289g-1.  
26.	Notwithstanding final publication of the Guidelines, NIH has failed to implement the Guidelines and has failed to complete the process for funding HPSC research.  To the contrary, defendants are re-examining the Guidelines, purportedly from both a legal and a policy perspective.  Defendants= review includes, inter alia, a re-examination of the HHS General Counsel=s recent conclusion that the Guidelines do not violate ' 510 of the Consolidated Appropriations Act, 2001, Pub. L. No. 106-554.
1.	
27.	This re-examination has already delayed federal funding of HPSC research.  On or about April 20, 2001, defendants canceled the April 25, 2001 inaugural meeting of the committee that was to review the first applications under the Guidelines from scientists seeking to demonstrate that their HPSC lines complied with the Guidelines, as a prerequisite to obtaining federal funds for human embryonic stem cell research.  On information and belief, the defendant NIH had intended to go forward with the initial review meeting so as to not delay unnecessarily the funding process, but was ordered by defendant HHS to cancel the meeting.  In doing so, defendants have suspended consideration of all applications for approval in this area.  Absent intervention by the Court, this delay in the application approval process will effectively prevent the use of federal funds for HPSC research during the current fiscal year.
28.	In a related case, Nightlight Christian Adoptions, et al v. Thompson, et al., No. 01-0502, defendants agreed with opponents of research involving human pluripotent stem cells to the following moratorium on May 3, 2001:
ADuring the pendency of the Review [of the Guidelines by HHS], the parties understand that Defendants will continue their present policy of not funding any research involving use of pluripotent stem cells derived from human embryos, including all independent investigator and intramural research.  The parties understand that during the Review period Defendants will not evaluate the scientific merits of any applications for funding of embryo stem cell research.  Similarly, the parties understand that during the period of Review Defendants will continue their present policy of postponing the review of compliance packages under the Guidelines.  Even if the Review results in consideration of funding for pluripotent stem cell research, it is understood that the NIH process for consideration of embryonic stem cell research will take at least thirty (30) days following conclusion of the Review.  Accordingly, Defendants will not fund any such research for a period of thirty (30) days following conclusion of the Review.@

	V.
	The Researcher Plaintiffs
29.	Plaintiff Dr. James Thomson is an Assistant Professor at the University of Wisconsin, Department of Anatomy.  He does research involving human pluripotent stem cells.  His address is The Wisconsin Regional Primate Research Center, The University of Wisconsin-Madison, 1220 Capitol Court, Madison, WI  53715-1299.
1.	
30.	Plaintiff Dr. Roger Pedersen is a Professor and Research Director, Department of Obstetrics, Gynecology and Reproductive Sciences at University of California,  San Francisco.  He does research involving human pluripotent stem cells.  His address is 533 Parnassus Avenue, San Francisco, CA  94143-0720.
31.	Plaintiff Dr. Douglas Melton is the Cabot Professor and Chairman of the Department of Molecular and Cellular Biology at Harvard University. He does research involving human pluripotent stem cells.  His address is Harvard University, Department of Molecular and Cellular Biology, 7 Divinity Avenue, Cambridge, MA  02138.
32.	Plaintiff Dr. John Gearhart is the C. Michael Armstrong Professor at The Johns Hopkins University.  He does research involving human pluripotent stem cells.  His address is The Johns Hopkins University, Gynecology and Obstetrics, Park Building, 600 North Wolfe Street, Baltimore, Maryland  21287.
33.	Plaintiff Dr. Dan Kaufman is a Fellow in the Department of Internal Medicine/Hematology at the University of Wisconsin.  He does research involving human pluripotent stem cells.  His address is University of Wisconsin Hospital and Clinics, Department of Internal Medicine/Hematology, 600 Highland Avenue, Madison, WI  53792.
34.	Plaintiff Dr. Alan Osborne Trounson is Deputy Director of the Institute of Reproduction and Development and Professor of Obstetrics and Gynaecology/Paediatrics at Monash University in Australia.  He does research involving human pluripotent stem cells.  His address is Institute of Reproduction and Development, Monash Medical Centre, 246 Clayton Road, Clayton Victoria 3168, Australia.
1.	
35.	Plaintiff Dr. Martin Pera is Associate Professor and Deputy Director of the Center for Early Human Development at Monash University in Australia.  He does research involving human pluripotent stem cells.  His address is Institute of Reproduction and Development, Monash Medical Centre, 246 Clayton Road, Clayton Victoria 3168, Australia.
36.	Drs. Thomson, Pedersen, Gearhart, Melton, and Trounson all have been principal investigators on NIH-funded grants or contracts.  Dr. Pera is listed as principal investigator on an research grant application that has been submitted to NIH, and Dr. Kaufman is eligible to be awarded funding as principal investigator on an NIH research grant or contract.
37.	All the researcher plaintiffs have applied or intend to apply for NIH funding involving human pluripotent stem cells if such funding becomes available and the current moratorium on funding is lifted.  Plaintiffs Drs. Pedersen, Trounson, and Pera are among the investigators who had submitted applications that were to be reviewed at the now-canceled April 25, 2001 NIH meeting referenced in Paragraph 26 above.
VI.
The Patient Plaintiffs
38.	Plaintiff Christopher Reeve is the founder and Chairman of the Board of the Christopher Reeve Paralysis Foundation.  Mr. Reeve has sustained paralysis as a result of a spinal cord injury.  The Foundation encourages and supports research to develop effective treatments and a cure for paralysis caused by spinal cord injury and other central nervous system disorders.  Human pluripotent stem cell research and the transplantation therapies it may produce are viewed by Mr. Reeve and his Foundation as a primary source for such a cure.  His address is 500 Morris Avenue, Springfield, NJ  07081.
1.	
39.	Plaintiff James Cordy suffers from Parkinson=s Disease and is interested in receiving a cellular replacement treatment that restores lost function.  Human pluripotent stem cell research and the transplantation therapies it may produce are viewed by Mr. Cordy as a primary source for such a treatment.  He believes that if a cure is delivered within five years, it will save his life, but that a cure ten years from now will be too late for him.  To meet his needs, federal funding of this research must begin.  His address is 6470 Monitor Street, Pittsburgh, PA 15217.
40.	Plaintiff James Tyree has been diagnosed with Type I diabetes since 1985.  He believes that HPSC research is vitally important in seeking to cure that disease.  His address is 1254 N. Lake Shore Drive, Chicago, IL  60610.
VII.
Defendants
41.	Defendant Tommy G. Thompson is the Secretary of HHS.  His official address is 200 Independence Avenue, S.W., Washington, D.C.  20201.  He is sued in his official capacity.  In this capacity, Secretary Thompson has the overall responsibility for the operation and management of HHS, of which NIH is an agency.  Secretary Thompson exercises cabinet level oversight and supervisory authority over the management and policy of the NIH.
42.	Defendant Dr. Ruth Kirschstein is the Acting Director of NIH, and has served in that position since January 1, 2000.  Dr. Kirschstein is sued in her official capacity.  Her official address is 9000 Rockville Pike, Bethesda, MD  20892.  Dr. Kirschstein has the overall responsibility for the operation and management of NIH.
43.	Defendant NIH is, and was at all times relevant hereto, an agency within Defendant HHS.  NIH conducts, regulates, and supports federally funded biomedical scientific research.  NIH is responsible for issuing and administering the Guidelines that are the subject matter of this suit.
1.	
VIII.
Jurisdiction and Venue
44.	This action arises under the Administrative Procedure Act, 5 U.S.C. '' 553 and 706(2); the Consolidated Appropriations Act, 2001, Pub. L. No. 106-554, 114 Stat. 2763; the NIH Revitalization Act, including the provisions codified in 42 U.S.C. '' 289g-1, 289g-1 (note), and 289g-2; and the Declaratory Judgment Act, 28 U.S.C. '' 2201 and 2202.  This case presents a federal question, and this Court has jurisdiction over this matter pursuant to 5 U.S.C. '' 702 and 703 and 28 U.S.C. ' 1331.  Venue is proper in this Court both because the original action to which this cross-claim is connected is located in this Court and because this is an action against officers and agencies of the United States, defendant HHS resides in this judicial district, defendant Tommy Thompson performs his official duties in this judicial district, and a substantial part of the events or omissions giving rise to this action occurred in this judicial district.  28 U.S.C. ' 1391(e).
	IX.
Irreparable Harm
45.	The defendants= failure to implement the Guidelines and begin the process for federal funding of human pluripotent stem cell research has caused, is causing, and will continue to cause irreparable harm to the plaintiffs and the public interest.
1.	
46.	The cancellation of the Guidelines review and funding process and the resulting delay and uncertainty in federal funding imposed by defendants after issuance of the final NIH Guidelines has caused, is causing, and will continue to cause irreparable harm to the researcher plaintiffs by preventing federal funding of important segments of their work, thereby preventing or delaying research using HPSCs from taking place; by restricting the collegial sharing of cell lines with other scientists; and by discouraging talented young researchers from joining their labs or entering the field of HPSC research. 
47.	With respect to the patient plaintiffs, the cancellation of the Guidelines review and funding process and the resulting delay and uncertainty in federal funding imposed by defendants after issuance of the Guidelines is preventing or delaying the development of potential treatments for conditions such as paralysis, Parkinson=s Disease, and diabetes, among others.  In particular, the current delay is preventing or delaying the advent of a cure that would benefit Mr. Reeve and the mission of his Foundation, Mr. Cordy, Mr. Tyree, and countless other Americans.
48.	The rescission of the provisions in the Guidelines for federal funding of research using HPSCs would cause irreparable harm to the plaintiff researchers and patients by preventing or delaying research using HPSCs, by restricting the collegial sharing of cell lines among scientists, by discouraging talented young researchers from entering the field of HPSC research, and by preventing or delaying the advent of a cure for paralysis, Parkinson=s Disease, diabetes, and other debilitating conditions.
Count I
NIH Revitalization Act of 1993
49.	The allegations contained in paragraphs 1 - 48 are incorporated by reference as if set forth in full herein.
50.	Human pluripotent stem cells derived from fetal or embryonic sources fall within the definition of Ahuman fetal tissue@ set forth in 42 U.S.C. ' 289g-1(g).
1.	
51.	The purpose of HPSC research is in large measure to develop cells and tissue for transplantation, and HPSC research thereby constitutes Aresearch on the transplantation of human fetal tissue for therapeutic purposes.@  42 U.S.C. ' 289g-1(a)(1).
52.	As a result, federal funding of HPSC research is subject to and falls within the ANullification of Moratorium@ protections in ' 113 of the NIH Revitalization Act, 42 U.S.C. 
' 289g-1 (note).
53.	Specifically, under ' 113(a) of the Act, no executive branch official may impose a policy prohibiting HHS and NIH from supporting HPSC research.  Moreover, under ' 113(b), the Secretary of HHS may not withhold funds for such research.
54.	Defendants= failure to implement the Guidelines and the current delay in funding HPSC research violates the NIH Revitalization Act and, accordingly, constitutes agency action contrary to law, 5 U.S.C. ' 706(2).
55.	Any alteration or rescission of the Guidelines to bar or restrict federal funding of research using HPSCs would further violate the NIH Revitalization Act.
56.	The provisions set forth in 28 U.S.C. '' 289g-1 and 289g-2 reflect the outcome of a legislative deliberation that took into account the needs of medical research and public health as well as the ethical and policy concerns over the use of tissue or cells obtained from embryos and fetuses.  The Guidelines follow and are consistent with those provisions, and defendants cannot defer or rescind the Guidelines in the name of striking a balance different than that set by the NIH Revitalization Act.
1.	
57.	Plaintiffs are entitled to a declaration that the Guidelines are consistent with and protected by the NIH Revitalization Act and to an injunction requiring defendants to implement the Guidelines and complete funding for HPSC research.
Count II
Administrative Procedure Act Procedures
58.	The allegations contained in paragraphs 1 - 48 are incorporated by reference as if set forth in full herein. 
59.	NIH followed informal rulemaking procedures under ' 553 of the Administrative Procedure Act, 5 U.S.C. ' 553, in developing the Guidelines and was required to do so.  The Guidelines were made final and immediately effective on August 25, 2000.
60.	NIH must adhere to and implement the Guidelines unless and until they are modified through rulemaking procedures in accordance with 5 U.S.C. ' 553.  The Guidelines embody a regulation of general applicability and public significance and do not involve merely the funding of particular grants or contracts.
61.	The current review of the Guidelines by defendants does not comply with the Administrative Procedures Act because defendants have not followed the notice and comment procedures provided therein.
62.	Plaintiffs are entitled to declaratory and injunctive relief barring defendants from failing to implement the Guidelines and from altering or rescinding the Guidelines except in strict compliance with the Administrative Procedure Act.

Count III
Prohibition of Arbitrary and Capricious Acts
63.	The allegations contained in paragraphs 1 - 48 are incorporated by reference as if set forth in full herein.
64.	Defendants= statutory duty is to fund research that, based on scientific considerations, is best designed to understand, treat, and cure disease.  Specifically, federal law provides that the Secretary of HHS and Director of the NIH Ashall conduct in [NIH], and shall encourage, cooperate with, and render assistance to other appropriate public authorities, scientific investigators, and scientists in the conduct of, and promote the coordination of, research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and impairments of man . . . .@  42 U.S.C. '' 241 and 282.  In carrying out that mission, the Secretary and Director are authorized to Amake grants-in-aid to universities, hospitals, laboratories, and other public or private institutions, and to individuals for such research projects as are recommended by the advisory council to the entity of the Department supporting such projects . . . .@  Id.
65.	Defendants= failure to implement the Guidelines and to fund HPSC research is contrary to those statutory duties (as well as the NIH Revitalization Act of 1993) and constitutes unlawful, arbitrary, and capricious agency action under 5 U.S.C. ' 706(2).
66.	Plaintiffs are therefore entitled to declaratory and injunctive relief requiring defendants to implement the Guidelines and barring defendants from rescinding the Guidelines.

	Count IV
	Declaratory Judgment That Federal Funds May
	Be Used to Support Human Pluripotent Stem Cell Research

67.	The allegations contained in paragraphs 1 - 48 are incorporated by reference as if set forth in full herein. 
68.	The Guidelines are fully consistent with ' 510 of the Consolidated Appropriations Act, 2001.  The Guidelines do not provide for funding of research in which human embryos are destroyed, discarded, or knowingly subjected to excess risk; to the contrary, the Guidelines prohibit such funding.  Instead, the Guidelines permit funding of research using HPSCs after such cells have already been derived using non-federal funds.  Thus, the Guidelines correctly distinguish between funding of activities that are proscribed by ' 510 and funding of activities that are not precluded by that section of the Act.
69.	The Guidelines are also fully consistent with and supported by other applicable law, including without limitation '' 111-113 of the NIH Revitalization Act, Pub. L. No. 103-43; the statutory sections concerning the purposes, authority, and duties of the Public Health Service and the NIH, 42 U.S.C. '' 241, 282, and 289a-1; and the Administrative Procedure Act.
70.	Despite the legality of the Guidelines, the defendants are reviewing the Guidelines, purportedly for purposes of determining if the Guidelines conflict with ' 510 of the Consolidated Appropriations Act, 2001, and have refused to implement the Guidelines while this review is ongoing.
71.	In light of the foregoing, plaintiffs are entitled to a declaratory judgment that the Guidelines are lawful and that defendants are legally obligated to implement the Guidelines.
1.	

PRAYER FOR RELIEF
WHEREFORE, Plaintiffs pray that:
72.	This Court issue a declaratory judgment that defendants= failure to implement the NIH Guidelines for Research Using Human Pluripotent Stem Cells violates sections 111-113 of the NIH Revitalization Act, 42 U.S.C. '' 289g-1, 289g-1 (note), and 289g-2; the applicable statutes governing defendants, including 42 U.S.C. '' 241, 282, 284, and 289a-1; and the Administrative Procedure Act, 5 U.S.C. ' 553 and 706;
73.	This Court issue an injunction ordering defendants to proceed immediately with implementation of the NIH Guidelines for Research Using Human Pluripotent Stem Cells, including all steps necessary to complete the application approval process for federal funding of research using HPSCs; 
74.	This Court issue a declaratory judgment declaring that the NIH Guidelines for Research Using Human Pluripotent Stem Cells do not violate ' 510 of the Consolidated Appropriations Act, 2001 or any other provision of law; and
75.	This Court grant plaintiffs such other and further relief as is deemed just and equitable.

Respectfully submitted,
____________________________
Marci A. Eisenstein					Jeffrey C. Martin
Max G. Brittain, Jr.					DC Bar No. 350421	
Frederick J. Sperling					Richard M. Wyner
Aphrodite Kokolis					DC Bar No. 376320
Julie J. Furer						Donald J. Munro
Schiff Hardin & Waite					DC Bar No. 453600
6600 Sears Tower					Shea & Gardner
Chicago, Illinois  60606				1800 Massachusetts Avenue, NW
(312) 258-5500					Suite 700
Washington, DC 20036
(202) 828-2000
Clarence T. Kipps, Jr.
DC Bar No. 007088
Miller & Chevalier
1450 G Street, NW
9th Floor
Washington, DC  20005
(202) 626-5840

Attorneys for Plaintiffs

May 8, 2001