in the united states court of appeals for the district...

IN THE UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT

DR. JAMES L. SHERLEY, et al.,

Appellees,

v.

KATHLEEN SEBELIUS, et al.,

Appellants.

No. 10-5287

Dist. Court No. 1:09-CV-01575 (RCL) (D.D.C.)

OPPOSITION TO DEFENDANTS’ EMERGENCY MOTION TO STAY PRELIMINARY INJUNCTION PENDING APPEAL

Attorneys for Appellees Dr. James L. Sherley, et al.

Samuel B. Casey, Cal. Bar No. 76022 ADVOCATES INTERNATIONAL 9691 Main Street, Suite D Fairfax, VA 22031 (703) 894-1076 Steven H. Aden, D.C. Bar No. 466777 ALLIANCE DEFENSE FUND 801 G. Street N.W., Suite 509 Washington, D.C. 20001 (202) 393-8690

Thomas G. Hungar, D.C. Bar No. 447783 Bradley J. Lingo, D.C. Bar No. 490131 Ryan J. Watson, D.C. Bar No. 986906 Thomas M. Johnson, Jr.,

D.C. Bar No. 976185 GIBSON, DUNN & CRUTCHER LLP 1050 Connecticut Avenue, N.W. Washington, D.C. 20036 (202) 955-8500 Blaine H. Evanson, Cal. Bar No. 254338 Andrew G. Pappas, Cal. Bar No. 266409 GIBSON, DUNN & CRUTCHER LLP 333 S. Grand Avenue Los Angeles, CA 90071 (213) 229-7000

Case: 10-5287 Document: 1265730 Filed: 09/14/2010 Page: 1

INTRODUCTION

Appellants seek a stay of a preliminary injunction that enjoins Appellants

from funding research using human embryonic stem cells (“hESC”)—cells derived

by destroying live human embryos. This funding violates the plain language of the

Dickey-Wicker Amendment, where Congress prohibits federal funding of

“research in which” a human embryo is “destroyed, discarded, or knowingly

subjected to risk of injury or death.” Consolidated Appropriations Act, 2010, Pub.

L. No. 111-117, § 509(a)(2), 123 Stat. 3034, 3280–81. The district court correctly

concluded that a stay pending appeal, even of short duration, would “flout[] the

will of Congress,” and that “the public interest is served by preventing taxpayer

funding of research that entails the destruction of human embryos.” Add. 20.

As this Court has recognized, moreover, adult stem cell researchers like Drs.

Sherley and Deisher suffer “actual,” “imminent” injury from competition with

hESC researchers for scarce federal funding. Add. 83. If further proof were

needed, the National Institutes of Health (“NIH”) recently confirmed the urgent

need for a preliminary injunction to prevent these federal dollars from disappearing

forever. NIH ordered last week that for the duration of this Court’s temporary

administrative stay, hESC awards be “given priority” over other awards and that

certain hESC applications scheduled for consideration or renewal over the next


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several months be expedited.1 NIH likewise instructed that in-house (or

“intramural”) research on hESC may resume during the brief period of the

administrative stay.2 These actions confirm that a stay pending appeal would lead

to a flight of federal dollars into hESC research, causing Appellees and other NIH

grant applicants irreparable harm.

NIH provided no explanation based on science or the merits of the

competing proposals to justify allowing hESC applications to leapfrog proposals

filed by Appellees or any other NIH grant applicants. To the contrary, there is only

one explanation for NIH’s actions—an ideological preference for spending as

much federal money as practicable on illegal hESC research. Because the entire

purpose of the district court’s preliminary injunction was to prevent the

evaporation of such funds, a stay pending appeal would irreparably injure

Appellants and the public interest by undermining the injunction before this Court

has an opportunity to consider and rule on the merits of the appeal.

By contrast, Appellants’ claims of irreparable harm absent a stay rest on

1 Gretchen Vogel & Jocelyn Kaiser, NIH Rushes to Hand Out Stem Cell Grants During Temporary Stay, Science Insider (Sept. 10, 2010) (citing email from NIH Extramural Chief Sally Rockey), available at http://news.sciencemag.org/ scienceinsider/2010/09/nih-rushes-to-hand-out-stem-cell.html.

2 Meredith Wadman, NIH Tells Researchers to Recommence Stem Cell Work, The Great Beyond, nature.com, available at http://blogs.nature.com/news/ thegreatbeyond/2010/09/nih_tells_its_campus_researche.html.


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speculation, misinformation, and hyperbole. At every turn, Appellants present this

case as a choice between spending federal dollars on hESC research or nothing at

all. To the contrary, the district court’s preliminary injunction frees up millions of

dollars in grant money that NIH can now award to research projects that promise

more tangible medical benefits, raise fewer ethical issues, and comport with the

law. For example, the administrative record before NIH when it issued its current

hESC guidelines (the “Guidelines”) demonstrated the overwhelming scientific and

ethical advantages of adult and induced pluripotent stem cell research over hESC

research. Supp. Add. 26-33 (Pls.’ Mot. for Prelim. Inj. at 18-25).3 By contrast, the

most that NIH Director Francis S. Collins can muster in claiming irreparable injury

from denial of a stay is that hESC research “offer[s] hope” to patients suffering

from diseases and that beneficial treatments are “possible” in the future. Add. 47

(Collins Decl. ¶ 5); see generally Add. 58-70 (Deisher Decl.) (identifying

numerous factual errors in NIH’s assertions).

A stay pending appeal will result only in further injury to Appellees and

additional waste of taxpayer dollars being poured into an illegal, unethical, and

scientifically speculative enterprise. For these reasons, Appellants’ request for a

stay pending appeal should be denied.

3 A Supplemental Addendum is attached to this Opposition Brief.


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ARGUMENT

“In seeking a stay pending appeal, [a party] must show (1) that it has a

substantial likelihood of success on the merits; (2) that it will suffer irreparable

injury if the stay is denied; (3) that issuance of the stay will not cause substantial

harm to other parties; and (4) that the public interest will be served by issuance of

the stay.” United States v. Philip Morris, Inc., 314 F.3d 612, 617 (D.C. Cir. 2003).

Appellants cannot satisfy any of the stringent criteria for a stay.

I. Appellants Are Unlikely To Succeed On The Merits Of Their Claims.

A. Federal Funding of hESC Research Conflicts With The Plain Language Of The Dickey-Wicker Amendment.

The Dickey-Wicker Amendment forbids federal funding of “research in

which a human embryo or embryos are destroyed, discarded, or knowingly

subjected to risk of injury or death.” § 509(a)(2), 123 Stat. at 3280. The district

court correctly ruled that the NIH Guidelines “unambiguously” violate Dickey-

Wicker, because hESC research necessarily entails the destruction of human

embryos. Add. 12 (“To conduct ESC research, ESCs must be derived from an

embryo. The process of deriving ESCs from an embryo results in the destruction

of the embryo.”). This fact cannot be disputed, and indeed is recognized in the text

of the Guidelines themselves: They not only contemplate embryo destruction, but

expressly prescribe the very procedures by which live embryos must be selected


5

for destruction for purposes of government-funded research. See 74 Fed. Reg. at

32,170, 32,174 (July 7, 2009).4

Appellants resist this conclusion because, in their view, “research” on

embryonic stem cells does not include “the projects and actions that preceded it,”

i.e., the destruction of an embryo to derive the stem cells. Defs.’ Emergency Mot.

to Stay Prelim. Inj. Pending Appeal and Request for Immediate Admin. Stay

(“Defs.’ Mot.”) at 13. As Appellants concede, the Human Subject Protection

Regulations promulgated by the Department of Health and Human Services

(“HHS”), which are explicitly referenced in the Dickey-Wicker Amendment,

define the term “research” broadly as “‘a systematic investigation, including

research development, testing and evaluation, designed to develop or contribute to

generalizable knowledge.’” See Defs.’ Mot. at 13 (citing 45 C.F.R. § 46.102(d)).

The derivation of stem cells from embryos is plainly part of the same “systematic

investigation” as the ultimate tests conducted on such stem cells.

Appellants’ restrictive reading of the term “research” also ignores the fact

that the statutory text prohibits funding in which human embryos “are . . .

discarded.” § 509(a)(2), 123 Stat. at 3280 (emphasis added.) Appellants’ view

4 A full analysis of the text and structure of the Dickey-Wicker Amendment appears in Appellees’ pending motion for summary judgment, attached as Supp. Add. 52-119.


6

leads to the absurd conclusion that merely “discard[ing]” an embryo constitutes its

own, standalone “research” project, separate and apart from the experiments

performed on the cells derived from the discarded embryo. To the contrary, the

Amendment plainly prohibits funding for any “research” that entails, as one part of

an overall “systematic investigation,” the discarding or destruction of an embryo.

Even if Appellants’ warped reading of the term “research” were correct, the

funding they propose would still be illegal, because Dickey-Wicker’s prohibition

also encompasses research in which embryos are “knowingly subjected to risk of

injury or death.” § 509(a)(2), 123 Stat. at 3280. In order to give any meaning to

the phrase “knowingly subjected to risk of injury or death,” Appellants must be

prohibited from funding research that they know will place human embryos at

substantial risk of destruction. NIH, of course, is well aware that the stem cell

derivation process necessarily destroys an embryo; indeed, its Guidelines mandate

the specific procedures by which living human embryos are to be selected for

destruction. By creating a financial incentive for hESC research, and by specifying

the precise means by which embryos must be destroyed in order to qualify for

federal funding, NIH necessarily and knowingly subjects embryos to a substantial

risk of injury or death.

B. Appellants Have Never Interpreted The Term “Research” In The Dickey-Wicker Amendment, And Are Entitled To No Deference.

Appellants further argue that this Court should afford deference to NIH’s


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alleged interpretation that Dickey-Wicker does not bar research on human

embryonic stem cells. Defs.’ Mot. at 13-14. As an initial matter, the statute

plainly prohibits the funding of “research in which” embryos are destroyed or

knowingly threatened. Because “Congress has directly spoken to the precise

question at issue,” “that is the end of the matter,” and no deference is due to any

contrary view. Chevron U.S.A., Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837,

842-43 (1984).

Second, even if there were some ambiguity in the statute (and there is not),

Appellants would deserve no deference here, because neither NIH nor HHS has

ever proffered an authoritative interpretation of “research” that this Court could

analyze for reasonableness under Chevron. To receive deference, an agency must

in fact interpret the statutory provision in question, Pub. Citizen, Inc. v. Dep’t of

Health & Human Servs., 332 F.3d 654, 661 (D.C. Cir. 2003), and must do so in a

rule “carrying the force of law,” United States v. Mead Corp., 533 U.S. 218, 226–

27 (2001). NIH has never addressed what “research” means under the statute; to

the contrary, Appellants merely cite to a decade-old opinion of then-HHS General

Counsel Harriet S. Rabb that human embryonic stem cells “are not human

embryos.” Defs.’ Mot. at 6 (citing 65 Fed. Reg. at 51,976 (Aug. 25, 2000)). This

assertion is entirely beside the point, because it does not interpret the critical term

“research,” and does nothing to refute the common-sense conclusion that hESC


8

research is research “in which” human embryos are destroyed or subjected to a risk

of harm because it necessarily entails the destruction of human embryos. See, e.g.,

Pub. Citizen, 332 F.3d at 661 (holding that Chevron was “inapplicable”—even

though the agency’s guidance “[did] contain a reference” to the statute at issue—

because “there [was] no place in the manual where the agency explain[ed] why it

believe[d] that [its conclusion] satisfie[d] the statut[e]” ).

In any event, Appellants have not consistently interpreted Dickey-Wicker to

permit funding of research on biological material derived from living embryos. In

1996, for example, NIH wrote a letter to Georgetown University researchers who

were using federal dollars and equipment to conduct genetic tests on DNA derived

from previously-destroyed embryos. Supp. Add. 120. The purpose of the letter,

the NIH wrote, was “to clarify . . . the NIH position on embryo research.” Id. The

agency explained that “analysis from DNA derived from a human embryo”

violated the federal prohibition on research involving embryos, and that NIH

equipment “may not be used for embryo work of any kind.” Id. This conclusion

cannot be squared with Appellants’ litigation position that NIH has always

interpreted Dickey-Wicker to permit funding of hESC research.

C. Congress Did Not Ratify Appellants’ Supposed Interpretation Of The Guidelines By Reenacting Dickey-Wicker.

Finally, Appellants argue that Congress has adopted NIH’s interpretation by

reenacting Dickey-Wicker each year without substantive change, citing to snippets


9

of the legislative history to support their point. Defs.’ Mot. at 11-12. That

argument is baseless. Reliance on legislative history and assertions of implied

Congressional ratification are inappropriate when the statutory text is clear. E.g.,

Dep’t of Hous. & Urban Dev. v. Rucker, 535 U.S. 125, 132 (2002) (“reference to

legislative history is inappropriate when the text of the statute is unambiguous”);

Demarest v. Manspeaker, 498 U.S. 184, 190 (1991) (“Where the law is plain,

subsequent reenactment does not constitute an adoption of a previous

administrative construction.”); Brown v. Gardner, 513 U.S. 115, 121 (1994); Solid

Waste Agency v. United States Army Corps of Eng’rs, 531 U.S. 159, 169-70

(2001).

In any event, as Appellees have described at length elsewhere, the evidence

of Congressional intent on this point is mixed—indeed, many members of

Congress (including the Amendment’s cosponsor, Jay Dickey) have taken the

position that funding of hESC research violates the statute. Add. 31 (Pls.’ Opp. To

Defs.’ Mot. to Stay Prelim. Inj. at 9 n.2). Even the members of Congress who

support hESC research have recognized that NIH’s current position does not

comport with the plain terms of the Dickey-Wicker Amendment. For this reason,

in 2001, an additional subsection was introduced in the Senate version of the

Dickey-Wicker Amendment that would allow funding of all “stem cell research, on

embryos that have been created in excess of clinical need and will be discarded,


10

and donated with the written consent of the progenitors.” S. 1536, 107th Cong. §

510(c) (2001). The Executive Branch “strongly oppose[d] the Senate version”

because it modified the existing language and “would signal a weakening of the

Federal Government’s commitment to protecting human embryos,” and “strongly

support[ed] the House version” which retained the existing language. Office of

Management and Budget, Statement of Administrative Policy (Oct. 30, 2001),

available at http://www.whitehouse.gov/omb/legislative/sap/107-1/S1536-s.html.

Congress agreed and ultimately rejected the Senate version. Absent Congressional

adoption of statutory language along the lines of the Senate version, the Dickey-

Wicker Amendment must be construed—consistent with its plain terms—to

prohibit NIH from funding research in a manner that causes and incentivizes the

destruction of human embryos.5

II. Defendants Will Not Be Irreparably Harmed By Denial Of A Stay.

In their motion, Appellants speculate that the lower court’s preliminary

5 As Appellees explain in detail in their motions for a preliminary injunction and for summary judgment, Supp. Add. 24-41, 88-99, Appellants are also unlikely to succeed on the merits because NIH blatantly violated the Administrative Procedure Act (“APA”) in promulgating the Guidelines, by failing to consider or address comments demonstrating that hESC research fails to satisfy the agency’s own stated criteria for its decision, namely that funding be available only for research that is “ethically responsible” and “scientifically worthy.” 74 Fed. Reg. at 32,170. Those comments showed that the combination of adult stem cell and induced pluripotent stem cell research offers all of the medical benefits of hESC research without its ethical problems. Supp. Add. 26-33. Appellants do not even address these arguments, which independently suffice to warrant denial of a stay.


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injunction order, if kept in place for the brief period while an appeal is pending,

will purportedly waste federal grant money, terminate ongoing scientific

experiments, and prevent discovery of potentially life-saving cures to debilitating

illnesses. These speculations cannot withstand scrutiny.6

First, as demonstrated above, the harms that Appellants allege all flow from

the approval and funding of research prohibited by federal law. Because

Appellants have likely violated the law, they cannot seek equitable relief on the

basis that their actions were meritorious or could lead to beneficial results.

Second, the preliminary injunction currently in effect will necessarily be of

“short duration.” Hoffman-Laroche, Inc. v. Califano, 453 F. Supp. 900, 903

(D.D.C. 1978). Because the core of this case is a legal rather than a factual

dispute, this Court can proceed expeditiously to the merits of the appeal.7 In such

circumstances, “[i]ssuance of a preliminary injunction—especially one of the short

duration contemplated here—will not substantially harm [Appellants].” Id.

Third, despite the claims made in Appellants’ motion about the harm that

would supposedly befall them from the preliminary injunction, they provide little

6 As an initial matter, Appellants’ claims of urgency are belied by the fact that they did not file their “emergency” motion for a stay and for expedited briefing in the district court until August 31, over a week after the court issued its order and decision.

7 Appellees would not object to expedited consideration of the appeal.


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(if any) tangible evidence that any such harm is “certain and great,” and “of such

imminence that there is a clear and present need for equitable relief,” as required

by the governing standard. Wis. Gas Co. v. FERC, 758 F.2d 669, 674 (D.C. Cir.

1985) (emphasis and internal quotation marks omitted). Director Collins’s error-

prone declaration cites purely speculative injuries that may (or may not) occur at

some point while the appeal is pending, such as the possible death of lab animals

or the loss of researchers to opportunities in other countries. See Add. 52-53

(Collins Decl. ¶ 12, 14). On the issue of whether biological resources (such as cell

cultures) would be lost if research were temporarily halted, Dr. Collins repeatedly

hedges his conclusions, and states in general and cryptic terms that “it may take

months or years to recreate” undefined “unique materials” and “reagents” used in

current experiments. Id. (emphasis added).

Moreover, this unsupported assertion is belied by NIH’s recent instruction to

resume “intramural” research experiments during the brief period of this Court’s

administrative stay—despite the fact that the agency ordered a halt to such research

merely two weeks ago. Supra n.2. While Director Collins (and Appellants) also

speculate that it could take six to eight months to restart the peer review process

absent a stay (Defs.’ Mot. at 3; Add. 54), this claim is likewise at odds with NIH’s

recent instructions, which provide that certain pending hESC applications “may

proceed to initial peer review” during the administrative stay period. Supra n.1.


13

Appellants cannot have it both ways—either it takes months to restart

paused hESC experiments and approve pending proposals (in which case NIH’s

recent instructions to restart those activities pending this appeal would be futile) or

appellants would suffer minimal harm from a brief lapse in funding while this

Court rules on its legality.

Fourth, there is no basis for a stay on the ground that the lower court’s

preliminary injunction is supposedly overbroad, in that it will prevent NIH from

engaging in “peer review” of hESC grant applications or from conducting

“intramural” hESC research conducted exclusively by NIH scientists. Defs.’ Mot.

at 17-18. The scope of the injunction is justified because these practices are

precisely those that cause Appellees (and other adult stem cell researchers)

competitive injuries: the “peer review” process by reviewing and approving hESC

grant proposals, and the funding of “intramural” projects by reducing the overall

amount of NIH grant money available for other research.

Moreover, Appellants never briefed the “peer review” or “intramural”

research issues in opposition to Appellees’ motion for a preliminary injunction, nor

did they move to clarify the scope of the district court’s order below. Appellants’

failure to raise these issues in a timely manner in the district court should not

redound to their advantage in this Court; litigants should not be permitted to sit on

their hands and then complain that their own inaction has compounded the impact


14

of an adverse ruling.

Fourth, Appellants’ claim that a brief interruption in research could delay

scientific discoveries that could benefit people with debilitating illnesses is, as the

district court held, purely “speculative.” Add. 15. Although hESC research has

been in existence and privately fundable for over a decade, federal funding under

the challenged Guidelines started only during the pendency of this lawsuit; a short

additional delay while this Court considers the legality of such funding will not

meaningfully affect the pace of scientific discovery. To the contrary, although Dr.

Collins refers to the promise of embryonic stem cell research in his declaration, he

concedes that the discovery of cures through such research is a mere possibility

and has not yet been established. See Add. 46-48 (Collins Decl. ¶¶ 5, 7). Indeed,

Appellants admit in their motion that hESC research is “fraught with

uncertainties,” but nonetheless assert (without substantiation) that such research is

“vital” to our understanding and treatment of disease. Defs.’ Mot. at 19.

If anything, the administrative record that NIH had before it when it issued

the Guidelines (including many critical comments that the agency never

considered) showed that adult stem cells are a superior therapeutic and ethical

alternative to embryonic stem cells, and that induced pluripotent stem cell research

offers all the purported benefits of hESC research and more, without the ethical

problems. See Supp. Add. 26-33. Thus, maintenance of the district court’s


15

preliminary injunction will actually advance scientific progress and hasten future

medical cures by freeing up additional funds for more promising grant proposals—

such as adult and induced pluripotent stem cell research.

In short, Appellants’ claims of irreparable harm assume (wrongly) that

dollars not spent on hESC research will simply disappear into the ether. To the

contrary, the district court’s order makes those dollars available for other, more

promising and less ethically fraught medical research projects. In addition, if this

Court granted a stay and later upheld the district court’s preliminary injunction

order, it would cause Appellants additional harm because more illegal grant

applications would be considered and funded and more resources potentially would

be wasted on experiments that must ultimately be enjoined.

III. A Stay Pending Appeal Would Cause Substantial Harm To Appellees And Other Interested Parties.

In contrast to a temporary delay in illegal funding for research that raises

grave ethical issues and has not proven to yield tangible medical benefits,

Appellees and other interested parties (including adult stem cell researchers and

other NIH grant applicants) would suffer irreparable competitive and other injuries

from a stay of the preliminary injunction.

Appellants attempt to minimize the harm that Appellees will suffer from

lifting the preliminary injunction by mischaracterizing it as the “speculative


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interest” in avoiding competitive injury. Defs.’ Mot. at 4.8 Appellants’ argument

flies in the face of binding Circuit precedent and law of the case; this Court has

already recognized that Appellants suffer an “actual,” “imminent” injury from

being forced to compete with illegal grant applications for a limited pool of federal

dollars. Add. 83. They and other NIH applicants should not have to face such

illegal competition for a single additional day.

In the days following this Court’s grant of an administrative stay, NIH has

demonstrated that Appellees’ injuries are anything but speculative. NIH has issued

a blunt and unqualified directive to “give[] priority” to hESC research applications

and awards, creating special protocols for hESC research that are inapplicable to

adult stem cell and other research proposals that do not qualify for such “priority”

consideration. See supra pp. 1-2. For example, hESC grant applications

previously deferred for consideration to January 2011 will now be fast-tracked for

approval in October 2010 (supra n.1)—to the detriment of other grant applications

pending approval at NIH between now and January (including Dr. Sherley’s).

8 Appellants’ assertion that Dr. Sherley faces no risk of irreparable harm because he has already received $425,500 in NIH grant money under the Guidelines is a complete non sequitur. Defs.’ Mot. at 4. Dr. Sherley’s receipt of particular NIH dollars does nothing to vindicate his right to seek additional federal funding free from competition from illegal grant applications. For example, Dr. Sherley currently has NIH grant applications pending (see Add. 73 (Sherley Decl. ¶ 4)), and absent an injunction, will have to compete with illegal hESC research applicants for approval.


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Once these “priority” applications are approved and the money disbursed to and

expended by third parties, it will be beyond the reach of any other potential grantee

and any injunction.9 A stay would ensure the evaporation of federal dollars and

undermine the purpose of the preliminary injunction before this Court ever had an

opportunity to rule on the merits of this appeal. There is “‘no adequate

compensatory or other corrective relief’ that can be provided at a later date” to

Appellees to restore this lost funding. Bracco Diagnostics, Inc. v. Shalala, 963 F.

Supp. 20, 29 (D.D.C. 1997) (quoting Hoffmann-Laroche, 453 F. Supp. at 903); see

also Add. 14 (“[t]here is no after-the-fact remedy for this injury because the Court

cannot compensate plaintiffs for their lost opportunities to receive funds”).

The harm that will result from a stay pending appeal is not solely pecuniary

and is not limited to the Appellees that appear before the Court.10 Adult stem cell

9 NIH has taken the position that hESC research awards already granted to third parties “are not affected by the preliminary injunction order, and award recipients may continue to expend the funds awarded to them.” Status of Applications and Awards Involving Human Embryonic Stem Cells, and Submissions of Stem Cell Lines for Eligibility Consideration, National Institutes of Health (Aug. 30, 2010), available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-126.html (last viewed Sept. 13, 2010). The same fate will befall any federal dollars awarded to hESC grantees during the administrative stay and any stay pending appeal.

10 In ruling on Appellants’ motion, this Court may consider whether a stay would cause substantial harm to “other parties interested in the proceedings,” Washington Metro. Area Transit Comm’n v. Holiday Tours, 559 F.2d 841, 843 (D.C. Cir. 1977) (internal citation omitted), which includes the “impact on third parties.” O’Donnell Constr. Co. v. Dist. of Columbia, 963 F.2d 420, 429 (D.C. Cir. 1992).


18

research has a proven track record of producing tangible medical benefits, Add.

63-64, and a stay could prevent adult stem cell researchers and other NIH grant

applicants from developing further treatments. Appellants assert throughout their

motion that this Court’s decision will have an effect on researchers, patients with

diseases, and society as a whole. But properly understood, these considerations

weigh decisively against a stay. Appellants’ claims of harm to third parties (hESC

researchers and persons seeking medical cures) rest on an utterly false dichotomy,

namely the assumption that there is no alternative to funding hESC research. As

the administrative record makes clear, however, there are such alternatives,

including both adult and induced pluripotent stem cell research. Those alternatives

are more likely to result in cures for debilitating diseases, and thus more likely to

benefit patients. See, e.g., Supp. Add. 26-33. Therefore, Appellants’ claims of

harm to third parties are unfounded.

Finally, the harm to the embryos that would be destroyed if a preliminary

injunction were lifted—precisely the harm that the Dickey-Wicker Amendment

was enacted to prevent—would be irreversible. “Simply put, absent some form of

preliminary relief [the embryos] run[] the real risk of dying and in such

circumstances money damages would be wholly useless.” DiDomenico v.


19

Employers Coop. Indus. Trust, 676 F. Supp. 903, 907 (N.D. Ind. 1987).11

D. The Public Interest Favors Denial Of A Stay.

Finally, the public interest weighs strongly in favor of denying Appellants’

request for a stay. It is well-established that “[i]t is in the public interest for courts

to carry out the will of Congress and for an agency to implement properly the

statute it administers.” Mylan Pharms., Inc., v. Shalala, 81 F. Supp. 2d 30, 45

(D.D.C. 2000). As the district court correctly recognized, in passing Dickey-

Wicker, Congress necessarily “mandated that the public interest would be served

by preventing taxpayer funding of research that entails the destruction of human

embryos.” Add. 41.

Moreover, denial of a stay will serve the public interest by preventing a

wasteful diversion of public funds to needless and relatively unpromising research.

Because the Guidelines divert funds away from more promising types of research

and perpetuate popular misconceptions about the science of stem cells, a

preliminary injunction will serve the interest of the public.

11 It makes no difference for purposes of irreparable injury analysis that embryos are not yet mature human beings. On the contrary, courts have recognized that the threat of harm to a human being not yet born can constitute irreparable harm for purposes of determining the propriety of injunctive relief. See, e.g., Lewis v. Grinker, 1987 WL 8412, at *6 (E.D.N.Y. Mar. 6, 1987) (finding that denial of Medicaid may lead to irreparable harm to unborn child); Woe v. Perales, 1987 WL 108983 at * 3 (W.D.N.Y. Oct. 29, 1987) (finding that denial of prenatal care constitutes irreparable harm “[g]iven the importance of this pre-natal care to the health of the fetus and the future health of the yet unborn child”).


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Finally, denial of a stay will also serve the public’s interest by withholding

funding from a type of research that many taxpayers and States recognize to be

ethically and morally troubling. The laws of numerous States protect human life

from the moment of conception or otherwise protect human embryos from being

destroyed for the purpose of medical experimentation. See Supp. Add. 34-35. The

public interest is disserved by federal funding of an unethical research method

when more beneficial alternatives exist.

CONCLUSION

Because the Dickey-Wicker Amendment unambiguously precludes federal

funding of human embryonic stem cell research, and the Guidelines violate the

APA, Appellants have not demonstrated any likelihood of success on appeal. In

addition, neither they nor the public will suffer irreparable harm from the denial of

a stay, whereas Appellees will continue to suffer such harm if a stay is granted.

Moreover, the preliminary injunction ordered by the district court advances the

public interest by ensuring that adult stem cell researchers and other meritorious

NIH grant applicants can seek federal funding free from competition from illegal,

ethically dubious, and scientifically problematic embryonic stem cell research. For

these reasons, and for those stated above, Appellants’ motion for a stay pending

appeal should be denied.

DATED: September 14, 2010 Respectfully submitted,


By: /s/ Thomas G. Hungar

Thomas G. Hungar

Attorneys for Appellees Dr. James L. Sherley, et al.


Thomas G. Hungar, D.C. Bar No. 447783 Bradley J. Lingo, D.C. Bar No. 490131 Ryan J. Watson, D.C. Bar No. 986906 Thomas M. Johnson, Jr.,

D.C. Bar No. 976185 GIBSON, DUNN & CRUTCHER LLP 1050 Connecticut Avenue, N.W. Washington, D.C. 20036 (202) 955-8500 Blaine H. Evanson, Cal. Bar No. 254338 Andrew G. Pappas, Cal. Bar No. 266409 Gibson, Dunn & Crutcher LLP 333 S. GRAND AVENUE LOS ANGELES, CA 90071 (213) 229-7000


CERTIFICATE OF SERVICE

I hereby certify that on this 14th day of September, 2010, I electronically filed

the foregoing Opposition to Defendants’ Emergency Motion to Stay Preliminary

Injunction Pending Appeal with the Clerk of the Court for the United States Court of

Appeals for the D.C. Circuit by using the appellate CM/ECF system and by hand-

delivering four paper copies.

Service was accomplished on the following by the CM/ECF system:

Mark B. Stern [email protected] Stephanie Robin Marcus [email protected] Abby Christine Wright [email protected] U.S. Department of Justice 950 Pennsylvania Avenue, NW Washington, DC 20530-0001

R. Craig Lawrence [email protected] Ronald C. Machen, Jr. U.S. Attorney's Office 555 4th Street, NW Washington, DC 20530

Joel McElvain, Senior Counsel [email protected] U.S. Department of Justice Federal Programs Branch Room 7332 20 Massachusetts Avenue, NW Washington, DC 20530

/s/ Thomas M. Johnson, Jr. Thomas M. Johnson GIBSON, DUNN & CRUTCHER LLP 1050 Connecticut Avenue, N.W. Washington, D.C. 20036 (202) 955-8500 [email protected]


CERTIFICATE AS TO PARTIES, RULINGS, AND RELATED CASES

Pursuant to D.C. Circuit Rules 8(a)(4) and 28(a)(1), the undersigned counsel

certifies as follows:

A. Parties and Amici. Plaintiffs in the district court, and appellees in this

appeal, are Dr. James L. Sherley and Dr. Theresa Deisher. Nightlight Christian

Adoptions, Shayne Nelson, Tina Nelson, William Flynn, Patricia Flynn, Christian

Medical Association, and Embryos, were formerly plaintiffs in the district court,

but have been dismissed for lack of standing.

Defendants in the district court, and appellants in this appeal, are Kathleen

Sebelius, in her official capacity as Secretary of the Department of Health and

Human Services, Francis S. Collins, in his official capacity as Director of the

National Institutes of Health, and National Institutes of Health.

The district court denied the motion of Coalition for the Advancement of

Medical Research to appear as amicus in that court.

B. Rulings Under Review. The rulings under review are the August 23,

2010, order and memorandum opinion of the district court, issuing a preliminary

injunction. Sherley v. Sebelius, No. 1:09-cv-1575-RCL (D.D.C. Aug. 23, 2010)

(Lamberth, C.J.). The order and opinion appear at page 1 of the Addendum to

Appellants’ Emergency Motion to Stay. The district court’s opinion is also


available at 2010 WL 3296974.

Also under review is the district court’s September 7, 2010, order denying

the government’s motion for a stay pending appeal. Add. 19.

C. Related Cases. This matter has previously come before this Court in

Sherley v. Sebelius, No. 09-5374 (June 25, 2010). The opinion is available at 610

F.3d 69, and at page 74 of the Addendum. Counsel is aware of no other related

cases within the meaning of D.C. Circuit Rule 28(a)(1)(C).

/s/ Thomas M. Johnson, Jr. Thomas M. Johnson GIBSON, DUNN & CRUTCHER LLP 1050 Connecticut Avenue, N.W. Washington, D.C. 20036 (202) 955-8500 [email protected]


SUPPLEMENTAL ADDENDUM


TABLE OF CONTENTS

Page Plaintiffs’ Motion for Preliminary Injunctive Relief ......................................................1 Plaintiffs’ Motion for Summary Judgment ....................................................................52 Letter from Kate A. Berg (October 10, 1996) ............................................................120


IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

DR. JAMES L. SHERLEY; DR. THERESA DEISH-ER; NIGHTLIGHT CHRISTIAN ADOPTIONS, indi-vidually and as next friend for PLAINTIFF EM-BRYOS; SHAYNE AND TINA NELSON; WILLIAM AND PATRICIA FLYNN; CHRISTIAN MEDICAL ASSOCIATION,

Plaintiffs,

) ) ) ) ) ) ) )

v. ) ) )

Civil Action No. ____

KATHLEEN SEBELIUS, in her official capacity as Secretary of the Department of Health and Human Ser-vices; DEPARTMENT OF HEALTH AND HUMAN SERVICES; DR. FRANCIS S. COLLINS, in his offi-cial capacity as Director of the National Institutes of Health; NATIONAL INSTITUTES OF HEALTH,

Defendants.

) ) ) ) ) ) ) ) )

PLAINTIFFS’ MOTION FOR PRELIMINARY INJUNCTIVE RELIEF

Plaintiffs respectfully request a preliminary injunction enjoining Defendants from taking

any further actions to implement or apply the guidelines for public funding of research involving

stem cells derived from human embryos (“Guidelines”) promulgated by the National Institutes of

Health (“NIH”). 74 Fed. Reg. 32,170 (July 7, 2009). The Guidelines are contrary to law, arbi-

trary and capricious, and were not issued in accordance with the procedures required by law.

The grounds for the present Motion are fully set forth in the accompanying Memorandum

of Points and Authorities and Declarations of Dr. James L. Sherley, Dr. Theresa Deisher, Tina

Nelson, William T. Flynn, and Ronald L. Stoddart.

Case 1:09-cv-01575-RCL Document 3 Filed 08/19/09 Page 1 of 3

Supp. Add. 1



DR. JAMES L. SHERLEY; DR. THERESA DEISH-ER; NIGHTLIGHT CHRISTIAN ADOPTIONS, indi-vidually and as next friend for PLAINTIFF EM-BRYOS; SHAYNE AND TINA NELSON; WILLIAM AND PATRICIA FLYNN; CHRISTIAN MEDICAL ASSOCIATION,

Plaintiffs,

) ) ) ) ) ) ) )

v. ) ) )

Civil Action No. ____

KATHLEEN SEBELIUS, in her official capacity as Secretary of the Department of Health and Human Ser-vices; DEPARTMENT OF HEALTH AND HUMAN SERVICES; DR. FRANCIS S. COLLINS, in his offi-cial capacity as Director of the National Institutes of Health; NATIONAL INSTITUTES OF HEALTH,

Defendants.

) ) ) ) ) ) ) ) )

MEMORANDUM OF LAW IN SUPPORT OF PLAINTIFFS’ MOTION FOR PRELIMINARY INJUNCTION

Thomas G. Hungar, D.C. Bar No. 447783 Bradley J. Lingo, D.C. Bar No. 490131 Ryan G. Koopmans, D.C. Bar No. 986233 GIBSON, DUNN & CRUTCHER LLP 1050 Connecticut Avenue, N.W. Washington, D.C. 20036 (202) 955-8500 Blaine H. Evanson, Cal. Bar No. 254338 Alison E. Klingel, Cal. Bar No. 258194 GIBSON, DUNN & CRUTCHER LLP 333 S. Grand Avenue Los Angeles, CA 90071 (213) 229-7000

Samuel B. Casey, Cal. Bar No. 76022 Law of Life Project ADVOCATES INTERNATIONAL 8001 Braddock Road, Suite 300 Springfield, VA 22151 (703) 894-1076 Steven H. Aden, D.C. Bar No. 466777 ALLIANCE DEFENSE FUND 801 G. Street N.W., Suite 509 Washington, D.C. 20001 (202) 393-8690

Case 1:09-cv-01575-RCL Document 3-1 Filed 08/19/09 Page 1 of 48

Supp. Add. 2


i

TABLE OF CONTENTS

FACTUAL BACKGROUND ..........................................................................................................2

ARGUMENT ..................................................................................................................................6

I. Plaintiffs Are Likely To Prevail on the Merits of Their Claims. .............................6

A. The Guidelines Violate The Dickey-Wicker Amendment By Funding Research In Which An Embryo Is Destroyed. ..............................7

1. The Clear Text And Structure Of The Dickey-Wicker Amendment Preclude The NIH Guidelines. ....................................7

2. NIH’s Interpretation Of The Dickey-Wicker Amendment Is Untenable And Is Incompatible With NIH’s Own Understanding Of “Research.”.........................................................9

3. The Language And Purpose Of The Dickey-Wicker Amendment Have Not Changed. ...................................................12

B. The Guidelines Violate The Dickey-Wicker Amendment Even Under NIH’s Implausible Interpretation Of “Research.” ..........................15

C. The Guidelines Are Arbitrary And Capricious And Therefore Invalid Under The Administrative Procedure Act. ....................................16

1. NIH Failed To Offer A Rational Connection Between The Facts Found And The Decision To Fund Embryonic Stem Cell Research. ................................................................................18

2. NIH Failed To Consider Reasonable Alternatives To The Funding Of Embryonic Stem Cell Research. .................................22

3. Adult Stem Cell Research Is Not Only More Promising, It Also Avoids The Serious Moral Problems Of Research Using Human Embryos. .................................................................24

4. NIH Disregarded The Possible Effects Of The Guidelines On State Laws. ...............................................................................25

5. NIH Failed To Cogently Explain Why It Exercised Its Discretion To Create Inadequate Conflict-of-Interest Provisions And Meaningless Informed-Consent Requirements. ................................................................................28

6. NIH Failed To Respond To Significant Comments That Cast Doubt On The Reasonableness Of The Guidelines. ..............30

D. The Guidelines Were Not Issued In Accordance With The Procedures Required By Law. ...................................................................33


Supp. Add. 3


ii

1. NIH Provided Insufficient Time To Meaningfully Comment On The Draft Guidelines. ..............................................34

2. Former Director Kington Precluded An Effective Comment Period By Participating With An Unalterably Closed Mind. ........35

II. Absent An Injunction, The Plaintiffs Will Suffer Irreparable Harm. ....................37

III. The Balance of Hardships Heavily Favors Immediate Injunctive Relief. .............39

IV. The Public Interest Favors A Preliminary Injunction ............................................40

CONCLUSION ..............................................................................................................................41


Supp. Add. 4


iii

TABLE OF AUTHORITIES

Page(s)

Cases

Abbs v. Sullivan, 756 F. Supp. 1172 (W.D. Wis. 1990) ....................................................................................... 34

Ali v. Fed. Bureau of Prisons, 128 S. Ct. 831 (2008) .................................................................................................................. 8

Am. Equity Inv. Life Ins. Co. v. SEC, 2009 WL 2152351 (D.C. Cir. July 31, 2009) ........................................................................... 25

* Am. Mining Congress v. EPA, 907 F.2d 1179 (D.C. Cir. 1990) .................................................................................... 30, 31, 33

Arkansas v. Oklahoma, 503 U.S. 91 (1992) .................................................................................................................... 19

* Ass’n of Nat’l Advertisers, Inc. v. FTC, 627 F.2d 1151 (D.C. Cir. 1979) ................................................................................................ 35

Atchison, T & S.F.R. Co. v. Wichita Bd. of Trade, 412 U.S. 800 (1973) .................................................................................................................. 28

Bracco Diagnostics, Inc. v. Shalala, 963 F. Supp. 20 (D.D.C. 1997) ................................................................................................. 38

Califano v. Sanders, 430 U.S. 99 (1977) .................................................................................................................... 26

Can-Am Plumbing, Inc. v. NLRB, 321 F.3d 145 (D.C. Cir. 2003) .................................................................................................. 26

Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402 (1971) .................................................................................................................. 26

Covad Commc’ns Co. v. FCC, 450 F.3d 528 (D.C. Cir. 2006) .................................................................................................. 30

DiDomenico v. Employers Co-Op Indus. Trust, 676 F. Supp. 903 (N.D. Ind. 1987) ........................................................................................... 37

In re Estate of Smith v. Bowen, 656 F. Supp. 1093 (D. Colo. 1987) ........................................................................................... 35

Fla. Power & Light Co. v. United States, 846 F.2d 765 (D.C. Cir. 1988) .................................................................................................. 34

H.A.L. v. Foltz, 551 F.3d 1227 (11th Cir. 2008) ................................................................................................ 15

Harbor Gateway Commercial Prop. Owners’ Ass’n v. EPA, 167 F.3d 602 (D.C. Cir. 1999) .............................................................................................. 9, 12


Supp. Add. 5



Page(s)

iv

Hoffman-Laroche, Inc. v. Califano, 453 F. Supp. 900 (D.D.C. 1978) ............................................................................................... 39

Int’l Bhd. of Teamsters v. United States, 735 F.2d 1525 (D.C. Cir. 1984) ................................................................................................ 16

* Int’l Ladies’ Garment Workers’ Union v. Donovan, 722 F.2d 795 (D.C. Cir. 1983) ............................................................................................ 17, 23

Lewis v. Grinker, 1987 WL 8412 (E.D.N.Y. Mar. 6, 1987) .................................................................................. 37

McLean Trucking Co. v. United States, 321 U.S. 67 (1944) .................................................................................................................... 25

Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005) .................................................................................................................. 10

* Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (1983) ........................................................................................................ 17, 19, 28

Mova Pharm. Corp. v. Shalala, 140 F.3d 1060 (D.C. Cir. 1998) .................................................................................................. 6

Mylan Pharm., Inc., v. Shalala, 81 F. Supp. 2d 30 (D.D.C. 2000) .............................................................................................. 40

Nat’l Ctr. for Mfg. Sciences, Inc. v. City of Ann Arbor, 563 N.W.2d 65 (Mich. Ct. App. 1997) ..................................................................................... 10

* Nehemiah Corp. of Am. v. Jackson, 546 F. Supp. 2d 830 (E.D. Cal. 2008) ................................................................................ 35, 37

N.Y. Shipping Ass’n v. Fed. Mar. Comm’n, 854 F.2d 1338 (D.C. Cir. 1988) ................................................................................................ 25

Russello v. United States, 464 U.S. 16 (1983) ...................................................................................................................... 9

SEC v. Chenery Corp., 318 U.S. 80 (1943) .................................................................................................................... 25

Southern S.S. Co. v. NLRB, 316 U.S. 31 (1942) .................................................................................................................... 26

United States Telecomm. Ass’n v. FCC, 227 F.3d 450 (D.C. Cir. 2000) ............................................................................................ 19, 22

United States v. Garner, 767 F.2d 104 (5th Cir. 1985) .................................................................................................... 17


Supp. Add. 6



Page(s)

v

United States v. Walters, 997 F.2d 1219 (7th Cir. 1993) .................................................................................................. 15

Woe v. Perales, 1987 WL 108983 (W.D.N.Y. Oct. 29, 1987) ........................................................................... 37

Statutes

* 5 U.S.C. § 553 ............................................................................................................... 2, 30, 34, 35

* 5 U.S.C. § 706 ................................................................................................................. 1, 2, 16, 33

42 U.S.C. § 243(a) ........................................................................................................................ 26

42 U.S.C. § 284(c) ........................................................................................................................ 26

42 U.S.C. § 289g(b) .................................................................................................................... 5, 8

Balanced Budget Downpayment Act, Pub. L. No. 104-99, § 128, 110 Stat. 26 (1996) ................. 5

* Omnibus Appropriations Act of 2009, Pub. L. 111-8, § 509, 123 Stat. 524 (2009) .............. passim

2006 Ala. Acts ch. 419 .................................................................................................................. 27

La. Rev. Stat. § 9:122.................................................................................................................... 27

La. Rev. Stat. Ann. § 14:2(7) ........................................................................................................ 27

Minn. Stat. § 145.422 .................................................................................................................... 27

Mo. Ann. Stat. § 1.205.1(1) .......................................................................................................... 27

Neb. Rev. Stat. § 30-809(1) .......................................................................................................... 27

N.M. Stat. Ann. §§ 24-9A-1 et.seq. .............................................................................................. 27

18 Pa. C.S. §§ 3203, 3216 ............................................................................................................. 27

S.D. Code Laws Ann. § 21-5-1 ..................................................................................................... 27

Tex. Penal Code § 1.07(a)(26) ...................................................................................................... 27

Utah Code Ann. § 76-5-201(1)(a) ................................................................................................. 27

Regulations

45 C.F.R. § 46.102(d) ................................................................................................................... 10

45 C.F.R. § 46.204(b) ................................................................................................................. 5, 8

45 C.F.R. § 46.208(a)(2) ................................................................................................................. 5

36 Fed. Reg. 2,532 ........................................................................................................................ 34

65 Fed. Reg. 51,976 ...................................................................................................................... 12

66 Fed. Reg. 57,107 ...................................................................................................................... 12


Supp. Add. 7



Page(s)

vi

74 Fed. Reg. 32,170 ............................................................................................................... passim

Other Authorities

S. 1536, 107th Cong. § 510(c) (2001) .......................................................................................... 14

Bernadine Healy, M.D., Why Embryonic Stem Cells Are Obsolete, U.S. News & World Report, March 4, 2006 ............................................................................... 3

Department of Health and Human Services, Guidance on Engagement of Institutions in Human Subjects Research (Oct. 16, 2008) ............................................................................... 10

G. Kolata, Man Who Helped Start Stem Cell War May End It, N.Y. Times, Nov. 22, 2007 ................................................................................................... 4, 23

Gretchen Vogel, Breakthrough of the Year: Reprogramming Cells, 322 Science 1766 (2008) ............................................................................................................ 4

Junying Yu et al., Induced Pluripotent Stem Cell Lines Derived from Human Somatic Cells, 318 Science 1917 (2007) ............................................................................................ 4, 22

National Institutes of Health, Stem Cell Basics 14 (2009) ........................................................ 4, 22

Office of Management and Budget, Statement of Administrative Policy (Oct. 30, 2001) ........... 14

President Barack Obama, Signing of Stem Cell Executive Order and Scientific Integrity Presidential Memorandum (Mar. 9, 2009) ................................................................................ 18

Press Release, The White House, Fact Sheet: Embryonic Stem Cell Research (Aug. 9, 2001) ......................................................................................................................................... 13


Supp. Add. 8


This Court should enjoin Defendants from taking any further actions to implement or ap-

ply the guidelines for public funding of research involving stem cells derived from human em-

bryos (“Guidelines”) promulgated by National Institutes of Health (“NIH”). 74 Fed. Reg. 32,170

(July 7, 2009) (attached to Decl. of Bradley J. Lingo in Support of Pls.’ Mot. for Prelim. Inj.

(“Lingo Decl.”), Exh. A). Each of the well-established requirements for a preliminary injunc-

tion—likelihood of success on the merits, irreparable harm to the plaintiffs, the balance of hard-

ships, and public-interest considerations—weighs strongly in favor of an injunction.

Plaintiffs have a high likelihood of success on the merits of their claims. To begin, the

Guidelines violate federal law, which prohibits funding of “research in which” a human embryo

is “destroyed, discarded, or knowingly subjected to risk of injury or death.” Omnibus Appropr-

iations Act of 2009, Pub. L. 111-8, § 509(a)(2), 123 Stat. 803 (2009). It is indisputable that re-

search involving human embryonic stem cells necessarily and inevitably involves the destruction

of human embryos. (Lingo Decl., Exh. B at 5 [Comments of Do No Harm et al.].) Thus, Defen-

dants’ actions are clearly contrary to law, and are therefore invalid under the Administrative Pro-

cedure Act (“APA”), 5 U.S.C. § 706(2)(A).

In addition, the Guidelines should be set aside because in deciding to fund embryonic

stem cell research, NIH failed to explain how such funding will fulfill the Guidelines’ stated pur-

pose to support “ethically responsible” and “scientifically worthy” research and failed to address

substantial evidence in the administrative record showing that federal funding of such research

will in fact have the opposite effect. 74 Fed. Reg. 32,170. Scientific discoveries in adult stem

cell research have made it unnecessary to engage in research that destroys a human embryo.

NIH’s failure to explain its decision to fund embryonic stem cell research in light of less morally

problematic alternatives—and to nevertheless promulgate ethically dubious guidelines funding


Supp. Add. 9


2

scientifically obsolete research—is arbitrary and capricious. See 5 U.S.C. § 706(2)(A). Finally,

by giving interested parties a mere 34 days to comment on this important issue and refusing to

consider comments by those asking NIH to reconsider its decision to fund embryonic stem cell

research, NIH has failed to follow the procedures in the Administrative Procedure Act, 5 U.S.C.

§ 553.

This case provides the quintessential grounds justifying a preliminary injunction: Once

destroyed, an embryo cannot be revived. NIH began accepting embryonic stem cell research

funding applications even before the Guidelines took effect on July 7, 2009. Absent injunctive

relief, many embryos will be destroyed in federally funded research, and this irreparable harm to

Plaintiffs far outweighs any conceivable harm to Defendants or others in maintaining the status

quo. Given the significant moral, ethical, and scientific concerns at stake, injunctive relief is also

necessary to further the public interest.

FACTUAL BACKGROUND

I. The Use Of Stem Cells To Treat Medical Illness

Stem cell research holds the potential to treat many diseases that have long resisted tradi-

tional methods. But it is important to understand that, from both scientific and moral stand-

points, not all stem cells are created equal. There are three general types of stem cells: embryo-

nic, adult, and induced pluripotent. While embryonic stem cells have received much of the pub-

lic and media attention, scientists have been making dramatic breakthroughs in the use of adult

and induced pluripotent stem cells, and these latter and less morally objectionable research me-

thods have generated the vast majority of medical progress.

Embryonic stem cells—as the name implies—are found in the inner cell mass of a living

embryo. Because these cells are the building blocks of the human organism, they have the po-


Supp. Add. 10


3

tential to turn into any type of cell in the human body. In 1998, Dr. James Thomson, a professor

at the University of Wisconsin, discovered a process for deriving stem cells from embryos. De-

spite the ethical concerns of engaging in research that causes the death of a human embryo, many

researchers hailed the discovery and predicted that embryonic stem cell research would lead to

the cure of many diseases such as Parkinson’s, Alzheimer’s, and diabetes. Those predictions

have not come to pass. In fact, rather than treating a patient’s disease, research shows that em-

bryonic stem cells would likely form tumors when injected into the body. (Lingo Decl., Exh. B

at I-1, I-2.) In addition, because embryonic stem cells do not come from the patient, they would

likely be rejected by the patient’s immune system. (See Lingo Decl., Exh. B at G-8.) Thus, not

only have embryonic stem cells failed to demonstrate the miracle-working potential that some

had forecasted, research shows they have the potential to cause harm.

Adult stem cells are cells found in the body and in tissues normally discarded after birth

(such as umbilical cord blood and the placenta) that have the potential to generate most or all of

the different tissues in the human body. (Id. at G-1.) And, unlike embryonic stem cells, adult

stem cells have shown tremendous promise in treating disease. As former NIH head Dr. Berna-

dine Healy stated earlier this year, adult stem cells “have become stars” representing “most of the

stem cell triumphs that the public hears about.” Bernadine Healy, M.D., Why Embryonic Stem

Cells Are Obsolete, U.S. News & World Report, March 4, 2009, available at

http://health.usnews.com/blogs/heart-to-heart/2009/03/04/why-embryonic-stem-cells-are-

obsolete.html. Indeed, adult stem cells have verifiably treated countless individuals suffering

from a wide variety of diseases including, but not limited to, ovarian cancer, retinoblastoma,

brain tumors, testicular cancer, chronic and acute leukemias, breast cancer, renal cell carcinoma,

anemias, Crohn’s disease, rheumatoid arthritis, and juvenile diabetes. (Lingo Decl., Exh. B at G-


Supp. Add. 11


4

5–G-7.) In addition, adult stem cells do not present a risk of tumor formation, and because adult

stem cells often come from the patient’s own body, there is less risk of immune rejection. (Id. at

G-8.)

Induced pluripotent stem cells (commonly known as iPS cells or iPSCs), are adult cells

that have been genetically reprogrammed such that they are virtually identical to embryonic stem

cells. The process of replicating embryonic stem cells from human adult cells was discovered

less than two years ago by a group of researchers, including Dr. Thomson. (Lingo Decl., Exh. B

at H-2–H-3.) This discovery was a dramatic leap forward in developmental biology, hailed by

the journal Science as last year’s leading scientific breakthrough in any field. Gretchen Vogel,

Breakthrough of the Year: Reprogramming Cells, 322 Science 1766 (2008). These cells “meet

the defining criteria [that were] originally proposed for human [embryonic stem] cells, with the

significant exception that the [induced pluripotent stem] cells are not derived from embryos.”

Junying Yu et al., Induced Pluripotent Stem Cell Lines Derived from Human Somatic Cells, 318

Science 1917 (2007). In addition, unlike embryonic stem cells, NIH has stated that “tissues de-

rived from [induced pluripotent stem cells] will be a nearly identical match to the cell donor and

thus probably avoid rejection by the immune system.” Nat’l Institutes of Health, Stem Cell Ba-

sics 14 (2009), available at http://stemcells.nih.gov/staticresources/info/basics/ SCpri-

mer2009.pdf.

For these reasons, Dr. Thomson—the pioneer of embryonic stem cell research—has pub-

licly recognized that the availability of induced pluripotent stem cells will soon make research

using embryonic stem cells an anachronism. See G. Kolata, Man Who Helped Start Stem Cell

War May End It, N.Y. Times, Nov. 22, 2007, available at http://www.nytimes.com/

2007/11/22/science/22stem.html (quoting Dr. Thomson as saying, “[i]sn’t it great to start a field


Supp. Add. 12


5

and then to end it”). Others have similarly recognized that induced pluripotent stem cells offer

all of the scientific possibilities of embryonic stem cells—and more. For instance, Professor Ian

Wilmut—whose research brought about the first cloned sheep, Dolly—has declared that the in-

duced pluripotent “technique to obtain stem cells is now the most efficient technique for re-

searchers” and that “[induced pluripotent] cells are more useful than embryonic cells.” (Lingo

Decl., Exh. B at H-3.)

II. Public Funding And Embryonic Stem Cell Research

In 1996, Congress enacted an appropriations rider that prohibits federal funding of re-

search in which human embryos are harmed or destroyed. The rider, commonly known as the

Dickey-Wicker Amendment, provides in relevant part that: “(a) [n]one of the funds made avail-

able by this Act may be used 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 injury or death greater than that allowed for research on fetuses in

utero under 45 C.F.R. § 46.208(a)(2) and section 489(b) of the Public Health Service Act (42

U.S.C. § 289g(b)).” Balanced Budget Downpayment Act, Pub. L. No. 104-99, § 128, 110 Stat.

26, 34 (1996). The Dickey-Wicker Amendment has been included in every Health and Human

Services (“HHS”) appropriations bill since 1996, and has not been altered in any material re-

spect.1 See Omnibus Appropriations Act of 2009, Pub. L. 111-8, § 509(a)(2), 123 Stat. 803.

1 In 2005, the citation in the rider was changed from 45 C.F.R. § 46.208(a)(2) to 45 C.F.R. § 46.204(b). Whereas the old regulation allowed only minimal risk in every case, the new regulation appears to allow risk that is greater than minimal, as long as that risk “is caused solely by interventions or procedures that hold out the prospect of direct benefit” for the fetus.


Supp. Add. 13


6

From the time Congress passed the Dickey-Wicker Amendment, no federal money has

been spent on research that depended on the further destruction of human embryos. Neverthe-

less, on July 7, 2009—in the face of the federal ban and the ever-accumulating evidence that em-

bryonic stem cells are scientifically obsolete—NIH issued “Guidelines For Human Stem Cell

Research” that broadly promise federal funding for embryonic stem cell research that will neces-

sarily involve the destruction of now-living embryos. 74 Fed. Reg. 32,174. These Guidelines

mark the first use of federal funds in a way that will incentivize and cause the destruction of hu-

man embryos for research.

ARGUMENT

The NIH Guidelines violate a clear statutory provision that expressly precludes any fund-

ing for research in which embryos are injured or destroyed, and were in any event invalidly

promulgated because NIH ignored numerous comments it received setting forth effective alterna-

tives to embryonic stem cell research and numerous scientific and ethical problems with funding

research in which embryos are injured and destroyed. And because the implementation of the

Guidelines risks the destruction of the embryos, there is unquestionably a risk of irreparable

harm if NIH is not enjoined from further implementing the Guidelines. Thus, as set forth below,

each of the well-established requirements for a preliminary injunction—likelihood of success on

the merits, irreparable harm to the plaintiffs, the balance of hardships, and public-interest consid-

erations—weighs strongly in favor of an injunction. See Mova Pharm. Corp. v. Shalala, 140

F.3d 1060, 1066 (D.C. Cir. 1998).

I. Plaintiffs Are Likely To Prevail on the Merits of Their Claims

The Guidelines must be set aside for two compelling reasons. First, the Guidelines vi-

olate the plain language of the Dickey-Wicker Amendment, which strictly prohibits the funding


Supp. Add. 14


7

of “research in which a human embryo or embryos are destroyed, discarded, or knowingly sub-

jected to risk of injury or death.” Second, in promulgating the Guidelines NIH ignored scores of

comments detailing the scientifically and ethically superior alternatives to embryonic stem cell

research. Indeed, NIH ignored more than 60 percent of the public comments because those

comments did not support the agency’s preconceived decision to fund embryonic stem cell re-

search. In so doing, NIH rushed to a predetermined judgment that is not only scientifically and

ethically flawed, but also legally invalid.

A. The Guidelines Violate The Dickey-Wicker Amendment By Funding Research In Which An Embryo Is Destroyed.

1. The Clear Text And Structure Of The Dickey-Wicker Amendment Preclude The NIH Guidelines.

The NIH Guidelines violate Congress’s unambiguous prohibition against federal funding

of “research in which a human embryo or embryos are destroyed, discarded, or knowingly sub-

jected to risk of injury or death.” Pub. L. No. 111-8, § 509(a)(2). The ban on research that in-

volves the destruction of embryos is broad; funding is prohibited for the actual destruction of

embryos, and also for any “research in which . . . embryos are destroyed.” Id. Because it is in-

disputable that human embryonic stem cell research involves injury to and destruction of human

embryos, the text of the Dickey-Wicker Amendment plainly precludes federal funding for such

research.

NIH seeks to avoid Congress’s unambiguous ban on destructive embryo research by as-

serting that the funding ban applies only to the act of deriving the stem cells from the embryos,

but not to subsequent experiments on those cells. 74 Fed. Reg. 32,173. But this distinction ig-

nores the plain text of the statute, which not only prohibits funding for discrete acts that destroy

human embryos, but also for all “research in which” an embryo is “destroyed, discarded or kno-

wingly subjected to risk of injury or death.” Pub. L. No. 111-8, § 509(a)(2) (emphasis added).


Supp. Add. 15


8

Indeed, the Amendment contains two subsections: It prohibits the use of 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 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)).”2 Id. By its terms, sub-

section (1) prohibits funding for the specific act of creating a human embryo for research pur-

poses, while subsection (2) prohibits funding for all “research in which” a human embryo is de-

stroyed or knowingly threatened. NIH’s interpretation renders this two-section format nonsen-

sical: If Congress intended to forbid only the use of federal funds for specific acts that destroy

human embryos, it could have done so in a far simpler and more straightforward way by utilizing

the format of subsection (1) to prohibit funding for specific acts that destroy human embryos.

See Ali v. Fed. Bureau of Prisons, 128 S. Ct. 831, 840 (2008) (rejecting petitioner’s interpreta-

tion of a statute, in part because “[h]ad Congress intended to limit [the statute’s] reach as peti-

tioner contends, it easily could have written [it that way]”).

Congress instead chose to protect human embryos by enacting a much broader ban. Ra-

ther than banning funding only for specific acts that destroy human embryos, Congress banned

funding for any “research in which a human embryo or embryos are destroyed” or are “knowing-

ly subjected to risk of injury or death.” Pub. L. No. 111-8, § 509(a)(2) (emphasis added). Both

2 The cross-referenced regulation, when incorporated into the appropriations rider, effec-tively provides as follows: “No [human embryo] may be involved as a subject in any ac-tivity covered by this subpart unless: . . . the risk to the [human embryo] imposed by the research is not greater than minimal and the purpose of the activity is the development of important biomedical knowledge which cannot be obtained by any other means.” 45 C.F.R. § 46.204(b).


Supp. Add. 16


9

by its terms and by necessary implication, that prohibition bans the funding of research, such as

embryonic stem cell research, that is dependent upon and induces the destruction of human em-

bryos. NIH’s contrary reading improperly ignores the important differences in the way Congress

structured its ban on funding for the creation of human embryos, on the one hand, and its ban on

all research that destroys or threatens embryos, on the other. See Russello v. United States, 464

U.S. 16, 23 (1983) (holding that where Congress uses different language in proximate subsec-

tions of the same statute, courts must construe the statute to give effect to those differences in

language); Harbor Gateway Commercial Prop. Owners’ Ass’n v. EPA, 167 F.3d 602, 606 (D.C.

Cir. 1999) (“We see no reason to depart from the usual canon that when Congress uses different

language in different sections of a statute, it does so intentionally.”).

Common sense dictates that this language was chosen to ensure that embryos are not de-

stroyed to support federally funded experiments. Clearly, Congress did not enact the funding

ban because it was trying to save taxpayer money or reduce the deficit. It enacted the ban be-

cause it was concerned with the moral costs of research involving the destruction of human em-

bryos. NIH’s interpretation would make the Dickey-Wicker Amendment a hollow accomplish-

ment.

2. NIH’s Interpretation Of The Dickey-Wicker Amendment Is Untenable And Is Incompatible With NIH’s Own Understand-ing Of “Research.”

NIH’s supposed distinction between “research” with stem cells and “derivation” of stem

cells is also untenable on its face. As an initial matter, NIH itself has recognized that “research”

is not task specific. Under the Human Subject Protection Regulations—incorporated by Con-

gress in the Dickey-Wicker Amendment—“research” is defined as “a systematic investigation,

including research development, testing and evaluation, designed to develop or contribute to ge-

neralizable knowledge.” 45 C.F.R. § 46.102(d). In other words, research is a systematic process


Supp. Add. 17


10

involving multiple steps and procedures with the overall purpose of advancing knowledge. De-

rivation of human embryonic stem cells for scientific inquiry thus constitutes an integral part of

the research being conducted under NIH’s own regulations. Moreover, the Department of Health

and Human Service’s (“HHS”) own guidance on these regulations provides that an institution

that receives federal funding is generally engaged in human subjects research “even where all

activities involving human subjects are carried out by employees or agents of another institu-

tion.” Department of Health and Human Services, Guidance on Engagement of Institutions in

Human Subjects Research (Oct. 16, 2008), available at http://www.hhs.gov/ohrp/humansubjects/

guidance/engage08.html (emphasis added). Thus, NIH’s artificial division of labor between de-

riving stem cells from human embryos and using those cells is inconsistent with its own interpre-

tation of the term “research,” which recognizes that such activities constitute parts of an overall

research project.

NIH’s overly narrow interpretation of the funding ban’s use of the term “research” is also

inconsistent with courts’ use of that term. For instance, in Merck KGaA v. Integra Lifesciences I,

Ltd., 545 U.S. 193, 202 (2005) (emphasis added), the Supreme Court, in analyzing the scope of

the research exemption under the patent statute, acknowledged that “research” is a multi-phase

process rather than a single experiment: “There is simply no room in the statute for excluding

certain information from the exemption on the basis of the phase of research in which it is de-

veloped or the particular submission in which it could be included.” See also Nat’l Ctr. for Mfg.

Sciences, Inc. v. City of Ann Arbor, 563 N.W.2d 65, 68 (Mich. Ct. App. 1997) (agreeing that “re-

search is not limited to a specific experiment” but includes “other critical steps in the research

process [such as] the definition of the research agenda, raising the money to perform the neces-

sary experiments, and the monitoring and evaluation of the results”).


Supp. Add. 18


11

The Guidelines themselves acknowledge that research involving embryonic stem cells is

inextricably intertwined with, and indeed includes, the act of destroying human embryos. The

Guidelines demand that NIH-funded researchers delve into the matter of derivation to ensure that

the process by which the embryos were selected for destruction was in accordance with the

Guidelines. See 74 Fed. Reg. 32,170 (noting that “the Guidelines pertain primarily to the dona-

tion of embryos for the derivation of [human embryonic stem cells]”). NIH cannot plausibly

contend that the embryonic stem cell research that it proposes to fund is wholly separate and le-

gally distinct from the destruction of human embryos while also mandating that individuals do-

nating “human embryos for research purposes” be informed of “[w]hat would happen to the em-

bryos in the derivation of [the stem cells].” 74 Fed. Reg. 32,174 (emphasis added).

To demonstrate the implausibility of NIH’s interpretation of “research in which,” consid-

er that the Guidelines do not even prohibit funding to a researcher who both derives stem cells

from an embryo and then uses the cells in federally funded activities. Indeed, far from prohibit-

ing such funding, the Guidelines actually contemplate that the deriver and user may be the same

person. The Guidelines state that when it is “practicable,” the physician responsible for fertility

treatments should not have been the same person as “the researcher deriving and/or proposing to

utilize [human embryonic stem cells].” 74 Fed. Reg. 32,174 (emphasis added). The obvious im-

plication of the “and/or” construction is that a single researcher can both derive the cells and use

federal money for subsequent experiments on those cells. It defies common sense to suggest that

a federal grant recipient is not engaged in “research in which” a human embryo is destroyed

when the researcher is conducting a multi-phase study of stem cells and he derives the stem

cells—and thereby destroys an embryo—at phase one of the research effort. See Harbor Gate-

way, 167 F.3d at 606 (rejecting the EPA’s interpretation of an appropriations rider because “there


Supp. Add. 19


12

is no reason to mistrust the common sense understanding of the statutory language” (internal qu-

otation omitted)).

3. The Language And Purpose Of The Dickey-Wicker Amend-ment Have Not Changed.

NIH also contends that Congress—by passing the Dickey-Wicker Amendment each year

without change—has “accepted” its “consistent” and “long-standing” interpretation. 74 Fed.

Reg. 32,173. This argument is baseless, however, because HHS has not consistently interpreted

the funding ban. In addition, NIH has never funded research that was dependant on the further

destruction of human embryos, belying the notion that Congress has acquiesced in such conduct.

In 1999, HHS General Counsel Harriet S. Rabb issued a memorandum (“Rabb Memo-

randum”) in which she concluded that embryonic stem cells are not “embryos” under the Dick-

ey-Wicker Amendment. (Lingo Decl., Exh. D [Rabb Memorandum].) From that premise, she

reasoned that NIH could legally fund experiments on the stem cells after those cells had been

derived with private funds. Despite the fact that the Rabb Memorandum said nothing about the

scope of the word “research,” and was merely an opinion of agency counsel rather than a formal

interpretation by the agency head, NIH cited the Memorandum in promulgating its first guide-

lines involving human embryonic stem cells. 65 Fed. Reg. 51,976 (adopting the Rabb Memo-

randum’s conclusion that “federally funded research that utilizes [human embryonic stem cells]

would not be prohibited by the HHS appropriations law prohibiting human embryo research, be-

cause such cells are not human embryos”).

These guidelines were never implemented, however. They were initially stayed due to

litigation, and in November 2001, NIH formally withdrew the guidelines (66 Fed. Reg. 57,107)

after then-President Bush instituted a new policy to limit funding of embryonic stem cell re-

search to “existing stem cell lines where the life and death decision has already been made.”


Supp. Add. 20


13

Press Release, The White House, Fact Sheet: Embryonic Stem Cell Research (Aug. 9, 2001),

available at http://www.whitehouse.gov/the_press_office/Fact-Sheet-on-Presidential-Executive-

Order/. By withdrawing the guidelines, NIH also withdrew its reliance on the Rabb Memoran-

dum.

After NIH withdrew the guidelines, on January 11, 2002, HHS General Counsel Alex M.

Azar II issued a memorandum (“Azar Memorandum”) concluding that the new policy comported

with the federal funding ban. (Lingo Decl., Exh. B at F-1–F-8.) This time, HHS General Coun-

sel focused on the meaning of “research in which.” The Azar Memorandum concluded that

funding of experiments on “a discrete set” of existing stem cell lines for which the life-and-death

decision had already been made did not violate the Dickey-Wicker Amendment because such

funding “provides no incentives for the destruction of additional embryos.” In other words, be-

cause the “life and death decision” had already been made prior to the funding announcement,

there was no causal link between the federally funded research and the destruction of the em-

bryos.

The Azar Memorandum’s recognition of the need to consider whether NIH was creating

an incentive for the further destruction of embryos represented a shift in HHS General Counsel’s

interpretation of the Dickey-Wicker Amendment. Under the Rabb Memorandum’s earlier deri-

vation-versus-use interpretation, the question whether federal funding created an incentive for

researchers to derive more stem cells was irrelevant. Thus, even leaving aside the fact that both

memoranda were merely opinions of counsel rather than interpretations by the NIH Director,

NIH’s contention that it has “consistently” interpreted the Dickey-Wicker Amendment since

1999 is simply not true.


Supp. Add. 21


14

Even the members of Congress who support embryonic stem cell research have recog-

nized that NIH’s current interpretation does not comport with the plain terms of the Dickey-

Wicker Amendment. For this reason, in 2001, an additional subsection was introduced in the

Senate version of the Dickey-Wicker Amendment that would allow funding of all “stem cell re-

search, on embryos that have been created in excess of clinical need and will be discarded, and

donated with the written consent of the progenitors.” S. 1536, 107th Cong. § 510(c) (2001). The

Executive Branch “strongly oppose[d] the Senate version” because it modified the existing lan-

guage and “would signal a weakening of the Federal Government’s commitment to protecting

human embryos,” and “strongly support[ed] the House version” which retained the existing lan-

guage. Office of Management and Budget, Statement of Administrative Policy (Oct. 30, 2001),

available at http://www.whitehouse.gov/omb/legislative/sap/107-1/S1536-s.html. Congress

agreed and ultimately rejected the Senate version. Absent Congressional adoption of such statu-

tory language, the Dickey-Wicker Amendment must be construed—consistent with its plain

terms—to prohibit NIH from funding research in a manner that causes and incentivizes the de-

struction of human embryos.

* * *

The conclusion that the NIH Guidelines violate Congress’s funding ban is inescapable.

The Guidelines—which expressly regulate and induce the destruction of human embryos—

plainly allow funding for research in which embryos are destroyed. NIH’s contrary interpreta-

tion is implausible: It ignores the common usage of the term “research,” the structure of the

funding ban, and Congress’s purpose in avoiding the taxpayers’ complicity in the sacrifice of

human embryos.


Supp. Add. 22


15

B. The Guidelines Violate The Dickey-Wicker Amendment Even Under NIH’s Implausible Interpretation Of “Research.”

Contrary to NIH’s implicit assumption, moreover, the funding ban extends beyond re-

search in which embryos are destroyed: It also prohibits funding for research in which human

embryos are “knowingly subjected to risk of injury or death.” Pub. L. No. 111-8, § 509(a)(2)

(emphasis added). It is indisputable that those funding and conducting embryonic stem cell re-

search knowingly subject human embryos to substantial risk of injury or death. Thus, even as-

suming NIH’s implausible, task-specific interpretation of “research,” NIH cannot escape the

conclusion that the Guidelines violate the funding ban.

A person does not need to intend a consequence in order to act “knowingly”—he need

only set in motion a chain of events that ultimately leads to a foreseeable result. See, e.g., H.A.L.

v. Foltz, 551 F.3d 1227, 1230 (11th Cir. 2008) (holding that a state employee “knowingly sub-

jected [foster children] to a substantial risk of victimization” by placing another child with a his-

tory of aggressive sexual behavior in the same home (emphasis added)); United States v. Wal-

ters, 997 F.2d 1219, 1223 (7th Cir. 1993) (stating that a person “knowingly causes” the use of

the mails when he “acts with the knowledge that the use of the mails will follow in the ordinary

course of business, or where such use can reasonably be foreseen” (internal quotation omitted)).

Under NIH’s Guidelines, grant-awarding officials and federally funded researchers will “kno-

wingly subject” human embryos “to risk of injury or death” by funding and conducting embryo-

nic stem cell research that inevitably creates a substantial risk—indeed, a virtual certainty—that

more human embryos will be destroyed in order to derive more embryonic stem cells for re-

search purposes. If a private scientist, who derives and studies embryonic stem cells without use

of public money, destroys an embryo in order to satisfy a request for embryonic stem cells from

a federally funded scientist—a practice allowed under NIH’s Guidelines—the public scientist


Supp. Add. 23


16

knows that his request, which is an integral part of his research, will subject living human em-

bryos “to risk of injury or death.” The public scientist could work in the same laboratory, refer

to himself as a collaborator, and even watch as his request is carried out. In fact, as already ex-

plained, the Guidelines do not even prohibit the deriver and the user from being the very same

person, in which case the federally funded scientist would be absolutely certain that his research

subjects human embryos to death.

Similarly, by awarding new grants for embryonic stem cell research, NIH officials will

set in motion a chain of events that will create demand for additional, newly derived stem cells.

In so doing, there can be no question that NIH officials are knowingly subjecting human em-

bryos to risk of death. Indeed, as discussed, the Guidelines—by regulating the process by which

researchers destroy those embryos—explicitly contemplate the destruction of additional embryos

for purposes of federally funded research. See 74 Fed. Reg. 32,174. There can therefore be no

doubt that the research which the NIH’s Guidelines now promise to fund will involve “knowing-

ly” subjecting embryos to risks of injury and death, and the Guidelines therefore violate the

Dickey-Wicker Amendment even under NIH’s interpretation of the statutory language.

C. The Guidelines Are Arbitrary And Capricious And Therefore Invalid Under The Administrative Procedure Act.

In its too-hasty effort to overturn the previous policy, NIH did not engage in the statutori-

ly required “reasoned decisionmaking”: NIH failed to observe the procedures required by the

APA, and accordingly it promulgated Guidelines that are arbitrary and capricious within the

meaning of 5 U.S.C. § 706(2)(A). Cf. Int’l Bhd. of Teamsters v. United States, 735 F.2d 1525,

1531 (D.C. Cir. 1984). As set forth below, NIH has refused to consider important information

about embryonic, adult, and induced pluripotent stem cells, and in order to reach its desired re-

sult—and to lighten its intellectual and administrative load along the way—NIH simply disre-


Supp. Add. 24


17

garded more than 60 percent of the public comments on the Guidelines. In addition, the Guide-

lines are at odds with numerous state and federal laws, and the Guidelines’ provisions governing

conflicts of interest and informed consent procedures are irrational and incomplete.

When taking any final action, an “agency must examine the relevant data and articulate a

satisfactory explanation for its action including a ‘rational connection between the facts found

and the choice made.’” Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S.

29, 43 (1983). Importantly, courts do not simply “rubber stamp” an agency’s decision. United

States v. Garner, 767 F.2d 104, 116 (5th Cir. 1985). Instead, they undertake a “searching and

careful inquiry” to “ensure that the agency engaged in reasoned decisionmaking.” Int’l Ladies’

Garment Workers’ Union v. Donovan, 722 F.2d 795, 815 (D.C. Cir. 1983) (internal quotation

omitted). In determining whether an agency has engaged in “reasoned decisionmaking,” a court

must examine carefully the agency’s articulated basis for its decision. State Farm, 463 U.S. at

50. A court may neither supply its own rationale nor consider an agency counsel’s “post hoc ra-

tionalizations” to justify the agency’s decision. Id. On the basis of the agency’s explanation

alone, the court must determine “whether the decision was based on a consideration of the rele-

vant factors and whether there has been a clear error of judgment.” Id. at 43.

The Guidelines cannot survive this review. In its promulgation of the Guidelines, NIH

failed to provide a rational connection between the facts found and its choice to fund embryonic

stem cell research instead of scientifically and ethically superior adult stem cell research; failed

to consider viable alternatives such as induced pluripotent stem cell research; ignored relevant

considerations such as the inherent flaws of embryonic stem cells; disregarded the effects of the

Guidelines on state statutory regimes; failed to cogently justify the provisions addressing con-

flicts of interest and informed consent; and abdicated its responsibility to respond to significant


Supp. Add. 25


18

arguments made during the public comment period. The unsurprising result of this flawed deci-

sion-making process is an irresponsible set of Guidelines that fund unethical and unnecessary

research.

1. NIH Failed To Offer A Rational Connection Between The Facts Found And The Decision To Fund Embryonic Stem Cell Research.

The ostensible purpose of the Guidelines is to ensure that NIH funding is “ethically re-

sponsible, scientifically worthy, and conducted in accordance with applicable law.” 74 Fed.

Reg. at 32,170. This purpose echoes the President’s laudable goal of ensuring that “scientific

data is never distorted or concealed to serve a political agenda—and that we make scientific de-

cisions based on facts, not ideology.”3 And yet, ironically, NIH did just what the President criti-

cized: It allowed ideology, not facts, to drive its decision to fund research that is morally objec-

tionable and scientifically obsolete.

In contrast to embryonic stem cell research, adult stem cell research delivers far greater

medical benefits with fewer disadvantages; is ethically responsible; and comports with the law.

(Lingo Decl., Exh. B at 1–19, B-1–B-5, C-1–C-18, E-1–E-9, G-1–G-8, H-1–H-7, I-1–I-11, J-1–J-

8.) The administrative record demonstrates these facts, yet NIH has failed even to consider them

and accordingly has not fulfilled its statutory duty to establish a “rational connection” between

these facts and its choice to fund human embryonic stem cell research. See, e.g., United States

Telecomm. Ass’n v. FCC, 227 F.3d 450, 461 (D.C. Cir. 2000) (“Fundamental principles of ad-

3 President Barack Obama, Signing of Stem Cell Executive Order and Scientific Integrity Presidential Memorandum (Mar. 9, 2009), available at http://www.whitehouse.gov/ the_press_office/Remarks-of-the-President-As-Prepared-for-Delivery-Signing-of-Stem-Cell-Executive-Order-and-Scientific-Integrity-Presidential-Memorandum.


Supp. Add. 26


19

ministrative law require that agency action be based on a consideration of the relevant factors

and rest on reasoned decisionmaking in which the agency must examine the relevant data and

articulate a satisfactory explanation for its action, including a rational connection between the

facts found and the choice made.” (internal quotation marks omitted)).

NIH claims to be pursuing “scientifically worthy” stem cell research, 74 Fed. Reg. at

32,170, but the administrative record demonstrates that adult stem cell research offers far greater

medical benefits than embryonic stem cell research. (Lingo Decl., Exh. B at 9–13, 18, G-1–G-8,

H-1–H-7, I-1–I-11.) Unlike embryonic stem cell research, adult stem cell research has already

proven to be “scientifically worthy.” (Id.) Indeed, it has improved the health and saved the lives

of thousands of patients. (Id. at G-4.) Moreover, though one would not know it from reading

NIH’s Guidelines, adult stem cell research does not suffer from numerous shortcomings of em-

bryonic stem cell research. (Id. at G-1–G-8, I-1–I-11.) Because NIH overlooked many of the

shortcomings of embryonic stem cells—in their inherent properties, their development, and their

potential uses—NIH has failed to consider an important aspect of the problem. See Arkansas v.

Oklahoma, 503 U.S. 91, 113 (1992) (citing State Farm, 463 U.S. at 43). In sum, in light of the

successes of adult stem cell research, it simply blinks reality for NIH to claim that it is rationally

pursuing “scientifically worthy” research when it is, in fact, dedicating scarce funds to an unpro-

ven and inferior alternative.

Embryonic stem cells are inherently flawed because they are not normal cells. (Lingo

Decl., Exh. B at I-1.) Indeed, the formation of tumors by human embryonic stem cells is such an

essential characteristic of those cells that it is used to identify a cell as a pluripotent human em-

bryonic stem cell and serves as a quality control test used by commercial suppliers of human

embryonic stem cells. (Id. at I-2.) Research has shown that this propensity to form tumors is not


Supp. Add. 27


20

the product of a single aberrant embryonic stem cell but an inherent property of all embryonic

stem cell injections. (Id.) Tumor-producing cells are obviously highly flawed as potential medi-

cal cures—a fact that NIH does not even acknowledge, much less explain away.

Embryonic stem cells are also flawed in the manner in which they develop because they

do not differentiate into the type of cells needed for therapeutic treatments. Embryonic stem

cells differentiate only into fetal or immature cell types, rather than into fully functioning adult

cells. (Id.) And fetal cells are not adequate cell replacements for lost adult cells. Rather, expe-

rience shows that in vivo use of fetal tissue or cells leads to dangerous, uncontrolled cell growth

and tumor formation. (Id. at I-2–I-3.) NIH stands mute in the face of these serious problems

with embryonic stem cells.

Given the major scientific problems with embryonic stem cell research, it is unsurprising

that, although “more than a decade” has passed since the discovery of human embryonic stem

cells, they are “not currently being used clinically” and NIH can express only the hope that they

will someday deliver a modicum of their supposed “potential.” 74 Fed. Reg. 32,173–74. Not

only is NIH’s hope desperately misplaced, but the agency also elides a critical point: Adult stem

cell research offers proven results, not far-off wishes. Adult stem cells have already treated

countless individuals suffering from a wide variety of diseases including, but not limited to, ova-

rian cancer, retinoblastoma, brain tumors, testicular cancer, chronic and acute leukemias, breast

cancer, renal cell carcinoma, anemias, Crohn’s disease, rheumatoid arthritis, and juvenile (Type

I) diabetes. (See Lingo Decl., Exh. B at G-5–G-8.) Adult stem cells are currently being used to

clinically treat many diseases in human patients. Successful clinical trials include the use of

adult stem cells, in conjunction with chemotherapy or radiation, in treatments for a wide variety

of cancers, and adult stem cells have been used in treatments for sickle cell anemia and Fanco-


Supp. Add. 28


21

ni’s anemia. In short, it is not rational for NIH to dedicate scarce resources to embryonic stem

cell research when adult stem cells are already delivering verifiable medical results, and NIH did

not even attempt to explain its contrary conclusion.

When one considers the following characteristics of adult stem cells (as NIH should have

done), it is no wonder that only adult stem cells—and not embryonic stem cells—have delivered

substantial medical results:

• Unlike embryonic stem cells, adult stem cells do not pose a risk of tumor formation. (Id.

at G-2.)

• Adult stem cells provide a readily available and flexible source of stem cells for the

treatment of disease. (Id.)

• Adult stem cells can be harvested from virtually all body tissues, as well as tissues nor-

mally discarded after birth (i.e., umbilical cord blood and the placenta). (Id.)

• Adult stem cells often avoid the problem of immune rejection because, in most cases, a

patient’s own stem cells can be used for treatment. (Id.) This obviously is not true for

embryonic stem cell research, which destroys (rather than heals) the human life used to

supply the stem cells.

• Adult stem cells have demonstrated the ability to home to sites of tissue damage, allow-

ing for the development of “minimally invasive administration techniques.” (Id.)

• Adult stem cells have successfully been used to treat patients with certain autoimmune

diseases. (Id. at G-6.)

With nary a word about why it is ignoring the medical benefits of adult stem cell re-

search, NIH nonetheless decided to fund embryonic stem cell research. In doing so, the agency

utterly failed to “examine the relevant data and articulate a satisfactory explanation for its action,


Supp. Add. 29


22

including a rational connection between the facts and the choice made.” United States Tele-

comm. Ass’n, 227 F.3d at 461 (internal quotation marks omitted). NIH’s conduct in this regard is

quintessentially arbitrary and capricious.

2. NIH Failed To Consider Reasonable Alternatives To The Funding Of Embryonic Stem Cell Research.

Even if NIH had rationally chosen to fund embryonic stem cell research instead of pur-

suing adult stem cell research, the Guidelines would still have to be set aside because NIH failed

to consider sufficiently another vastly superior alternative to the funding of embryonic stem cell

research—namely, induced pluripotent stem cell research. Human induced pluripotent stem cell

research offers all of the potential of embryonic stem cell research, with none of the moral diffi-

culties. Accordingly, even if NIH had reason to believe that human embryonic stem cell re-

search would be as scientifically valuable as adult stem cell research, it would still be arbitrary

and capricious for NIH to fund embryonic stem cell research when it could achieve the same

scientific goals through the ethically superior alternative of research using human induced pluri-

potent stem cells.

Induced pluripotent stem cells are a perfectly viable substitute for embryonic stem cells.

In fact, they are virtually indistinguishable from embryonic stem cells. (Lingo Decl., Exh. B at

H-2.) As explained by Dr. Thomson, a pioneer in the field of embryonic stem cell research, in-

duced pluripotent stem cells “meet the defining criteria [that were] originally proposed for hu-

man [embryonic stem] cells, with the significant exception that the [induced pluripotent stem]

cells are not derived from embryos.” Yu, supra, 318 Science 1917. In addition, induced pluri-

potent stem cell research provides distinct advantages over embryonic stem cells. Because the

creation of induced pluripotent stem cells does not require use of embryos, eggs, or cloning,

iPSC research avoids the ethical concerns associated with embryonic stem cell research. (Lingo


Supp. Add. 30


23

Decl., Exh. B at H-4.) In addition, induced pluripotent stem cell lines can be created from a spe-

cific individual, allowing creation of patient-specific cell lines. (Id.) Several such lines have al-

ready been created from individuals with specific diseases so that disease mechanisms and po-

tential drug-based therapies can be studied in the laboratory. (Id.) Indeed, NIH itself has recog-

nized that, unlike embryonic stem cells, “tissues derived from [induced pluripotent stem cells]

will be a nearly identical match to the cell donor and thus probably avoid rejection by the im-

mune system.” Stem Cell Basics, supra at 14.

Induced pluripotent stem cell research is a well-known, viable alternative to embryonic

stem cell research. In fact, according to Dr. Thomson, it will not be long before embryonic stem

cell research will be obsolete and the stem cell debate “will be just a funny historical footnote.”

Kolata, supra. Induced pluripotent stem cell research was mentioned in the notice announcing

the consideration of the Guidelines, 74 Fed. Reg. at 18,578, and the promise and possibilities of

the research were explicitly described in the comments received (see Lingo Decl., Exh. B), but

NIH offered no explanation in the final Guidelines as to why it chose to authorize funding of eth-

ically problematic human embryonic stem cell research rather than focusing on the ethically su-

perior and scientifically equivalent alternative of induced pluripotent stem cell research. Be-

cause NIH has offered no adequate explanation for why it chose to fund embryonic stem cell re-

search when research using induced pluripotent stem cells offers the same (or even greater)

promise, the Guidelines are arbitrary and capricious. See, e.g., Int’l Ladies’ Garment Workers’

Union, 722 F.2d at 817 (stating that the APA “demands an adequate explanation when [such an

alternative is] rejected”).


Supp. Add. 31


24

3. Adult Stem Cell Research Is Not Only More Promising, It Also Avoids The Serious Moral Problems Of Research Using Hu-man Embryos.

NIH offers no rational justification for its decision to pursue ethically problematic em-

bryonic stem cell research instead of focusing on adult stem cell research and/or induced pluripo-

tent stem cell research. There is widespread concern over the ethics of human embryonic stem

cell research. A deep concern is justified by the fact that human embryonic stem cell research

necessarily involves the killing of a human embryo during the harvesting of the embryonic stem

cells, and there is a scientific consensus that each such embryo is the “beginning of a new human

being.” Keith L. Moore & Persaud, T.V.N., The Developing Human: Clinically Oriented Em-

bryology 2 (7th ed. 2003). As noted in comments submitted to NIH, “[a]dvisory groups seeking

to inform federal policy on human embryo research have consistently acknowledged that fact,

and recognized that it has serious moral implications.” (Lingo Decl., Exh. C at 2 [Comments of

the U.S. Conference of Catholic Bishops].) Indeed, NIH’s own Human Embryo Research Panel

noted in 1994 that human embryos “warrant serious moral consideration as a developing form of

human life.” Nat’l Inst. Health, Report of the Human Embryo Research Panel 2 (Sept. 1994).

Similarly, the National Bioethics Advisory Commission has recognized our society’s widespread

agreement that “human embryos deserve respect as a form of human life.” Nat’l Bioethics Advi-

sory Comm’n, 1 Ethical Issues in Human Stem Cell Research ii (Sept. 1999). Given these ethi-

cal concerns, it is not surprising that the Commission ultimately concluded that “the derivation of

stem cells from embryos remaining following infertility treatments is justifiable only if no less

morally problematic alternatives are available for advancing the research.” Id. at 53 (emphasis

added).

Because adult and induced pluripotent stem cell research does not involve the killing of

human embryos, there are morally superior alternatives. And because embryonic stem cell re-


Supp. Add. 32


25

search is not the “only”—and, indeed, is the worst—alternative, NIH erred in pursuing it. More-

over, NIH also arbitrarily and capriciously disregarded, and failed to justify, its decision in light

of the very goal that it explicitly set for itself, namely, that NIH-funded research must be “ethi-

cally responsible.” 74 Fed. Reg. at 32,170. It is impossible to justify as “ethically responsible”

the destruction of human life in order to conduct research that could be conducted as well or bet-

ter without the destruction of human life, and in any event NIH did not even try to explain how

its funding of human embryonic stem cell research meets its own stated criterion. That is the es-

sence of arbitrary and capricious decision-making. See Am. Equity Inv. Life Ins. Co. v. SEC,

2009 WL 2152351, at *10 (D.C. Cir. July 31, 2009) (holding that an agency “must defend its

analysis before the court upon the basis it employed in adopting that analysis”—even if “the

[agency] was not required” by statute to base its decision on those grounds) (citing SEC v. Che-

nery Corp., 318 U.S. 80, 87 (1943)).

4. NIH Disregarded The Possible Effects Of The Guidelines On State Laws.

In addition to ignoring much of the science of human stem cell research, the Guidelines

fail to account for, and substantially undermine, the laws of numerous States that protect human

life from the moment of conception or otherwise protect human embryos from being destroyed

or placed at risk for the purpose of medical experimentation. An agency “must engage in a care-

ful analysis of the possible effects of [agency action] on the functioning and policies of other sta-

tutory regimes.” N.Y. Shipping Ass’n v. Fed. Mar. Comm’n, 854 F.2d 1338, 1365, 1367, 1371

(D.C. Cir. 1988) (citing McLean Trucking Co. v. United States, 321 U.S. 67 (1944)). Because

NIH disregarded the statutory regimes across several States with which the new Guidelines

would be in tension, it has not satisfied this requirement.


Supp. Add. 33


26

Congress specifically directed that NIH, when exercising its statutory discretion, must

cooperate with state regulatory regimes. See, e.g., 42 U.S.C. § 243(a) (asserting that the HHS

Secretary “shall assist States” in the enforcement of state health regulations); id. § 284(c)(1)

(stating that NIH “shall coordinate” its activities with other public entities). But NIH promulgat-

ed the Guidelines without even mentioning—much less attempting to comply with or accommo-

date—state regulations that ban the destruction of human embryos, even though NIH was in-

formed during the public comment period of the numerous state regulations at issue. This alone

is fatal to the Guidelines: Where a statute requires an agency to take into account conflicting or

concurrent regulatory schemes, failure to do so is ipso facto arbitrary and capricious and an

abuse of discretion. See Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 416 (1971)

(agency action must take into account factors Congress intended it to consider), overruled on

other grounds by Califano v. Sanders, 430 U.S. 99 (1977); Southern S.S. Co. v. NLRB, 316 U.S.

31, 37–38 (1942) (failure to take into account conflicting regulatory scheme is an abuse of dis-

cretion); Can-Am Plumbing, Inc. v. NLRB, 321 F.3d 145, 153–54 (D.C. Cir. 2003) (the National

Labor Relations Board “‘must . . . minimize[ ]’” and “take into account” the “impact of its ac-

tions on the policies of the other [conflicting] statute”).

That conclusion is particularly warranted in this case. State protection of human embryos

is pervasive. See generally Jean R. Schroedel, Is the Fetus a Person?: A Comparison of Policies

Across Fifty States (Cornell 2000). For example, many States have fetal homicide statutes that

apply without regard to gestational age.4 Some States have wrongful death statutes that apply

4 See, e.g., 2006 Ala. Acts ch. 419 (amending the definition of “person,” when referring to the victim of a criminal homicide or assault, to mean “a human being, including an un-[Footnote continued on next page]


Supp. Add. 34


27

regardless of gestational age.5 Still other States explicitly proclaim that life begins at concep-

tion.6 (See also Lingo Decl., Exh. B at B-1–B-5, C-1–C-18.) Finally—and perhaps most impor-

tantly—a number of States explicitly ban or restrict human embryonic stem cell research. See,

e.g., La. Rev. Stat. § 9:122; Minn. Stat. § 145.422; N.M. Stat. Ann. §§ 24-9A-1 et.seq.; 18 Pa.

C.S. §§ 3203, 3216.

NIH’s Guidelines make no attempt to coordinate federal stem cell research with the re-

quirements of state law. Instead, NIH has acted as though the existence of conflicting state regu-

lations is not even a matter of passing concern: Under the Guidelines, neither NIH nor a grant

recipient has any obligation to guarantee that federally funded research complies with state law.

This is no trivial matter: In States that acknowledge and protect life from the moment of fertili-

zation or conception, “donation” of human embryos for the purpose of destruction may be

viewed as a state criminal violation. The Guidelines fail even to consider this possibility, and

improperly seek to encourage and fund potentially illegal activity.

[Footnote continued from previous page]

born child in utero at any stage of development, regardless of viability”); Tex. Penal Code § 1.07(a)(26) (defining the term “individual,” as used in the Texas Penal Code, to mean “a human being who is alive, including an unborn child at every stage of gestation from fertilization until birth”); Utah Code Ann. § 76-5-201(1)(a) (stating that when refer-ring to the victim of a criminal homicide, the term “another human being” includes “an unborn child at any stage of its development”).

5 See, e.g., Neb. Rev. Stat. § 30-809(1) (amending wrongful death statute to include “an unborn child in utero at any stage of gestation”); S.D. Code Laws Ann. § 21-5-1 (amend-ing wrongful death statute to include “an unborn child”).

6 See, e.g., Ark. Const. amend. 68, § 2 (“The policy of Arkansas is to protect the life of every unborn child from conception until birth . . . .”); Mo. Ann. Stat. § 1.205.1(1) (“[t]he life of each human being begins at conception”) (preamble).


Supp. Add. 35


28

Because NIH has failed to even consider state regulations, NIH’s promulgation of the

Guidelines exceeds the scope of its discretion under both its enabling statute and the APA.

5. NIH Failed To Explain Cogently Why It Exercised Its Discre-tion To Create Inadequate Conflict-of-Interest Provisions And Meaningless Informed-Consent Requirements.

Science and statutory regimes aside, even at the core of the Guidelines, NIH has acted ar-

bitrarily and capriciously. By creating insufficient conflict-of-interest safeguards and inadequate

informed-consent standards, the Guidelines evince superficial concern about ethical issues, but

do nothing significant to address those concerns. Because NIH did not explain why two impor-

tant aspects of the Guidelines do not fulfill the purposes they purport to serve, the agency has not

satisfied the APA’s requirement that an agency “cogently explain why it has exercised its discre-

tion in a given manner.” State Farm, 463 U.S. at 48; see also Atchison, T & S.F.R. Co. v. Wichi-

ta Bd. of Trade, 412 U.S. 800, 806–07 (1973).

a. The Conflict-Of-Interest Provisions Leave Loopholes That Eviscerate Their Effectiveness.

Although the Guidelines set out to create the appearance of protection against conflicts of

interest, the vagueness of the procedural requirements creates an unacceptable risk that these

conflicts will survive. The Guidelines claim to fund only “ethically responsible” research using

cells that were “created using in vitro fertilization for reproductive purposes and were no longer

needed for this purpose.” 74 Fed. Reg. at 32,170, 32,174. The loose procedural requirements,

however, fail to ensure achievement of this objective. The Guidelines do not prohibit contrac-

tual, agency, or corporate relationships between the in vitro fertilization clinic that creates and

then cryogenically stores the human embryo, the researchers who destroy that human embryo to

harvest its stem cells, and NIH-funded researchers who will continue the research process with

respect to these human embryonic stem cells. Indeed, the Guidelines do not even prohibit the


Supp. Add. 36


29

deriver and the user from being the very same person. See 74 Fed. Reg. at 32,174. By allowing

the same person or clinic to be involved in the creation of embryos “for reproductive purposes”

and the research using the embryos that are “no longer needed,” the Guidelines tempt researchers

to evade the Guidelines’ requirements and create additional embryos at the outset to ensure that

there are “spares” left for research. See id. NIH avoided any real analysis of these issues by

proclaiming that it “is not always possible” to avoid this situation. Id. at 32,173. This ipse dixit

does not even come close to satisfying NIH’s duty to engage in reasoned decisionmaking.

Furthermore, the Guidelines erroneously presume that the parents of the human embryo

have the legal right under applicable state law, as well as the moral and ethical authority, to subs-

titute their judgment for the interests and judgment of the legally incompetent human embryo.

But parents’ moral and ethical authority to do so is far from accepted. Without a judicial pro-

ceeding in which the interests of the human embryo in question are represented by a court-

appointed attorney pro vita (for life), such a parental “donation” could violate state laws and

would create obvious conflicts of interest.

b. The Informed-Consent Requirements Fail To Inform Parents Of The True Nature Of The Procedure To Which They Are Consenting.

The Guidelines fail to describe adequately the true nature of the procedure to which “do-

nors” are consenting. The so-called informed consent provisions are deficient from a scientific,

legal, and practical perspective. Scientifically, the informed consent procedures fail to notify

potential donors that each of their human embryos is a living human being and that the decision

to donate is, in fact, a life-or-death decision. A researcher is required only to include information

about “[w]hat would happen to the embryos in the derivation of [human embryonic stem cells]

for research.” 74 Fed. Reg. at 32,174. The gravity of the decision to donate living human beings

for destruction cannot possibly be conveyed in such coy and evasive language. Moreover, the


Supp. Add. 37


30

informed-consent requirements also fail to inform potential donors that many States hold that

human life begins at conception, see, e.g., Ark. Const. amend. 68, § 2; La. Rev. Stat. Ann.

§ 14:2(7), and that in these States, the “donation” of human embryos for research may be deemed

to be a criminal act. In addition, the informed consent procedures do not always require donors

to be informed that adoption is an alternative to having the human embryo killed for research

purposes. 74 Fed. Reg. at 32,174; see also Natalie Lester, Embryo Adoption Becoming the Rage,

Wash. Times, Apr. 19, 2009, http://washingtontimes.com/news/2009/apr/19/embryo-adoption-

becoming-rage.

In sum, by including conflict-of-interest and informed-consent requirements, NIH has

created the appearance of being concerned about the ethical problems involved with human em-

bryonic stem cell research without taking the appropriate action to address those concerns. Be-

cause the agency has not “cogently explain why it has exercised its discretion” in this manner,

the Guidelines are arbitrary and capricious.

6. NIH Failed To Respond To Significant Comments That Cast Doubt On The Reasonableness Of The Guidelines.

For no apparent reason, the Executive Branch created a rushed and result-oriented rule-

making process in which it could not and did not respond to the majority of significant comments

that it received. See also § I.D.1, infra (the comment period was of insufficient length); id.

(NIH’s Acting Director had an unalterably closed mind about the rulemaking). 5 U.S.C.

§ 553(c) of the APA requires the agency to “respond in a reasoned manner to those [comments]

that raise significant problems.” Covad Commc’ns Co. v. FCC, 450 F.3d 528, 550 (D.C. Cir.

2006); see Am. Mining Congress v. EPA, 907 F.2d 1179, 1190–91 (D.C. Cir. 1990). NIH utterly

failed to do so, and it therefore acted arbitrarily and capriciously. See id. at 1191 (“the agency’s

failure to respond to . . . specific challenges in the record is fatal here, since ‘the points raised in


Supp. Add. 38


31

the comments were sufficiently central that agency silence . . . demonstrate[s] the rulemaking to

be arbitrary and capricious’”).

NIH received “approximately 49,000 comments” on the Guidelines. 74 Fed. Reg. at

32,170. Many of those comments raised substantial problems with the Guidelines—including all

of the arguments made here. (See, e.g., Lingo Decl., Exh. B at 2 (explaining, inter alia, that hu-

man embryonic stem cell research is “unnecessary and inappropriate” due to the scientific ad-

vances in adult and induced pluripotent stem cell research); id., Exh. C at 2 (explaining, inter

alia, that the informed consent protocols are insufficient for the “life-and-death decision” parents

are being asked to make).)

Yet, after the comment period ended, NIH had only forty-two days to review the 49,000

comments submitted and respond to the significant arguments presented therein. Even a team of

ten people working twelve hours per day for all forty-two days would have only six minutes to

devote to each comment. With some comments spanning over 100 pages, the task was unwieldy.

And yet, the requirements of the APA do not yield. “That an agency has only a brief span of

time in which to comply . . . cannot excuse its obligation to engage in reasoned decisionmaking

under the APA.” Am. Mining Cong., 907 F.2d at 1191.

NIH’s task of reviewing and responding to important comments was made substantially

easier by its stunning decision not to consider—much less respond to—more than 60 percent of

the comments. NIH received “[a]bout 30,000” comments “debat[ing] whether the NIH should

be funding embryonic stem cell research.” Jeffrey Young, Administration Unveils Stem Cell

Rules, The Hill, July 6, 2009, available at http://thehill.com/leading-the-news/obama-

administration-unveils-stem-cell-rules-2009-07-06.html. But NIH admits that it “disregarded all

such comments,” and it instead branded such comments with the (ironic) label “unresponsive.”


Supp. Add. 39


32

Id. NIH’s then-Acting Director offered this feeble post hoc excuse: “‘[NIH] actually did not ask

the public whether we should fund research on human embryonic stem cells. [NIH] asked the

public how we should fund human embryonic stem cell research.” Id. (emphases added). This

illegitimate decision to assume the answer to the fundamental question at issue cannot justify the

agency’s decision to completely ignore the majority of the comments that it received. Indeed, if

agencies could proceed in this manner, it would obliterate the purpose of APA’s public comment

process. NIH’s blatant disregard for the statutorily mandated rulemaking process is illegitimate,

and its effects can be seen throughout the final version of the Guidelines.

In the Guidelines, NIH did not make any attempt to explain its decision to allocate scarce

funds to embryonic stem cell research instead of adult stem cell research. Nor did it address the

issue whether induced pluripotent stem cells are superior to embryonic stem cells. Consistent

with this theme, the agency’s response to evidence that embryonic stem cells create tumors was

complete silence. And the agency failed to offer any adequate response to concerns about how

the Guidelines would conflict with numerous State laws. In the unusual situations where NIH

bothered to read and (at least superficially) respond to comments, the agency often offered insuf-

ficient categorical statements. For example, when responding to the comment that potential do-

nors should be informed that derivation of embryonic stem cells destroys the embryo, NIH of-

fered nothing but obfuscation. The agency declared that “all necessary details are explained and

understood” in the informed consent process, but that it could not require disclosure of informa-

tion about the destruction of embryos because it did not want to mandate “exact wording for the

consent forms.” 74 Fed. Reg. at 32,173. This response was entirely inadequate, and indeed,

misleading. As NIH well knows, the Guidelines need only modify the substance of the required

disclosure, not its “exact wording.” In fact, the Guidelines contain an enumerated list of seven


Supp. Add. 40


33

disclosures. Surely one of those could and should reflect—in substance—that the “donated”

embryo will be destroyed.

Such categorical—and, ultimately, unresponsive—statements are insufficient to satisfy

the APA’s requirements. In American Mining Congress v. EPA, petitioners submitted comments

challenging the agency’s listings of the materials as hazardous, including specific evidence that

was contrary to the EPA’s findings, but the EPA responded with categorical statements rather

than empirical analysis. 907 F.2d at 1190–91. As a result, the court held that “the agency’s fail-

ure to respond to petitioners’ specific challenges in the record [was] fatal . . . , since the points

raised in the comments were sufficiently central that agency silence . . . demonstrate[d] the rule-

making to be arbitrary and capricious.” Id. at 1191 (internal quotation marks omitted). That

precedent is directly applicable here.

NIH’s flagrant disregard for public input has been evident since the inception of this (all

too brief) rulemaking process. At bottom, the agency’s disregard for important public comments

reflects a disregard for a congressionally mandated process that cannot simply be jettisoned in

favor of political expediency. That congressionally mandated process requires the agency to

consider and respond to important public comments. Because NIH failed to offer more than

conclusory statements in response to the significant arguments raised by the comments to the

proposed guidelines, it has not engaged in the reasoned decisionmaking required by the APA.

Thus, the Guidelines are arbitrary and capricious and must be set aside.

D. The Guidelines Were Not Issued In Accordance With The Procedures Required By Law.

Wholly apart from the arbitrary and capricious nature of the NIH Guidelines, the Guide-

lines should be set aside because they were issued “without observance of procedure required by

law.” 5 U.S.C. § 706(2)(D). Agencies participating in rulemaking are required to follow the


Supp. Add. 41


34

procedures set out in 5 U.S.C. § 553. NIH violated these procedures by not allowing enough

time for submitting comments and by entering the rulemaking process with an “unalterably

closed mind.”

Under 5 U.S.C. § 553, agencies participating in rulemaking must publish “general notice

of the proposed rule making . . . in the Federal Register,” provide “interested persons an oppor-

tunity to participate in the rule making through submission of written data, views, or arguments,”

and incorporate “a concise general statement of [any adopted rule’s] basis and purpose.”

§ 553(b), (c). Although the APA exempts from its notice-and-comment requirement matters “re-

lating to agency management or personnel or to public property, loans, grants, benefits, or con-

tracts,” 5 U.S.C. § 553(a)(2), many agencies, including HHS, have specifically waived this ex-

emption. See Public Participation in Rule Making, 36 Fed. Reg. 2,532 (Feb. 5, 1971); see also

Abbs v. Sullivan, 756 F. Supp. 1172, 1188 (W.D. Wis. 1990) (applying the waiver to NIH),

judgment vacated on other grounds, 963 F.2d 918 (7th Cir. 1992). As the Department explained,

the “public benefit” from the “greater participation by the public in the formulation of this De-

partment’s rules and regulations . . . outweigh[s] any administrative inconvenience or delay.” 36

Fed. Reg. at 2,532.

1. NIH Provided Insufficient Time To Meaningfully Comment On The Draft Guidelines.

In direct contravention of § 553, NIH provided the public insufficient time to meaningful-

ly comment on the Draft Guidelines. NIH issued the Draft Guidelines and request for comment

on April 23, 2009, and all comments were due a mere 34 days later. 74 Fed. Reg. at 32,170.

This truncated comment period did not afford interested parties an adequate opportunity to com-

prehensively review and comment on the Draft Guidelines—especially given the scientific com-

plexity and ethical ramifications thereof. See Fla. Power & Light Co. v. United States, 846 F.2d


Supp. Add. 42


35

765, 771 (D.C. Cir. 1988) (explaining that a notice of proposed rulemaking must provide “ade-

quate time for comments,” and noting that interested parties should be able “to comment mea-

ningfully”); In re Estate of Smith v. Bowen, 656 F. Supp. 1093, 1097–99 (D. Colo. 1987) (hold-

ing that a sixty-day period was inadequate). Moreover, by short-circuiting the process by which

the public provides valuable information, the bobtailed comment period precluded NIH from

having sufficient information to engage in informed rulemaking.

2. Former Director Kington Precluded An Effective Comment Period By Participating With An Unalterably Closed Mind.

Unfortunately, it is now clear why NIH was not concerned about providing the public an

insufficient comment period: NIH never had any intention of considering the views of those op-

posed to the federal funding of embryonic stem cell research. Agencies cannot fulfill their duty

to consider important comments, see 5 U.S.C. § 553(b), when a participating agency member

“has an unalterably closed mind on matters critical to the disposition of the proceeding.” Ass’n

of Nat’l Advertisers, Inc. v. FTC, 627 F.2d 1151, 1170 (D.C. Cir. 1979). Former Director Ray-

nard Kington’s mind was “unalterably closed” from the outset.7

Agency members need not be excluded because of a “mere discussion of policy or advo-

cacy on a legal question.” Id. But when an agency member enters a rulemaking proceeding with

an “unalterably closed mind,” public comments are inevitably ignored. Id. In Nehemiah Corp.

of Am. v. Jackson, 546 F. Supp. 2d 830, 848 (E.D. Cal. 2008), the district court determined that

HUD Secretary Jackson entered a rulemaking proceeding with an “unalterably closed mind”

about the merits of a proposed rule. During the comment period, a Bloomberg News report

7 Kington served as the Acting Director of NIH from October 31, 2008 to August 7, 2009, when the Senate confirmed Dr. Francis Collins as the new Director of NIH.


Supp. Add. 43


36

quoted Secretary Jackson as stating his views on the proposed rule and claiming that HUD “in-

tend[ed] to approve the new rule by the end of the year even if the agency receive[d] critical

comments.” Id. at 847. After setting aside the rule on other grounds, the district court ordered,

based on these statements, that Secretary Jackson be excluded from the decision-making process

on remand. Id. at 848.

Kington’s prejudgment of this matter is even more striking. Kington made clear his

views on the result of the rulemaking proceeding before the comment period even began. On

April 17, Kington reported to the press that NIH “will expand greatly the number of cell lines

eligible for funding.” Guatam Naik, NIH Offers Rules for Embryonic Stem Cell Research, Wall

St. J., Apr. 17, 2009, available at http://online.wsj.com/article/SB123999343505429693.html

(emphasis added). Moreover, Kington and NIH demonstrated their prejudgment of this matter

by encouraging the submission of applications for embryonic stem cell research even before the

issuance of the draft Guidelines. See Implementation of Executive Order on Removing Barriers

to Responsible Scientific Research Involving Human Stem Cells, NOT-OD-09-085 (Apr. 17,

2009), available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-085.html.

Then, after the comment period concluded, Kington made a stunning admission: He (and

the agency) totally ignored all public comments that took a particular side of the central debate

in this rulemaking. See Young, supra. Approximately 30,000 of the 49,000 comments ad-

dressed the fundamental question “whether the NIH should be funding embryonic stem cell re-

search.” Id. But Kington utterly refused to consider comments that disagreed with his position,

id., that NIH should “expand greatly the number of cell lines eligible for funding,” Naik, supra.

Kington claimed that NIH “did not ask the public” for input on this question. Young, supra. But

an agency official may not hide an unalterably closed mind by prejudging an issue, ignoring tens


Supp. Add. 44


37

of thousands of comments that address the issue, and then declaring brazenly that he “did not

ask,” id., for comments that disagreed with his predetermined judgment.

It is beyond dispute that Kington had an “unalterably closed mind” about the merits of

the NIH Guidelines. Because the administrative proceeding has now concluded, “the appropriate

remedy” is to “vacate and remand the proceeding to be redone without the participation” of

Kington. Nehemiah, 546 F. Supp. 2d at 847.

II. Absent An Injunction, The Plaintiffs Will Suffer Irreparable Harm.

There can be little doubt that, absent an injunction, the plaintiffs will suffer irreparable in-

jury. Once destroyed, an embryo cannot be revived; it is gone forever. This “injury” is great

enough to meet any standard. “This is not a case where plaintiff can wait until trial for a remedy.

Simply put, absent some form of preliminary relief, plaintiff runs the real risk of dying and in

such circumstances money damages would be wholly useless to plaintiff.” DiDomenico v. Em-

ployers Co-Op Indus. Trust, 676 F. Supp. 903, 907 (N.D. Ind. 1987).8 In addition, the destruc-

tion of the embryo results in irreparable injury for all to whom that embryo holds promise. It is

no longer available to parents that might wish to adopt it or adoption agencies that might wish to

place it for adoption.9

8 It makes no difference for purposes of irreparable injury analysis that the embryos in question are not yet mature human beings. On the contrary, the threat of harm to a hu-man being not yet born constitutes irreparable harm for purposes of deciding the question of injunctive relief. See, e.g., Lewis v. Grinker, 1987 WL 8412, at *6 (E.D.N.Y. Mar. 6, 1987) (finding that denial of Medicare may lead to irreparable harm of unborn child); Woe v. Perales, 1987 WL 108983 (W.D.N.Y. Oct. 29, 1987) (finding that denial of pre-natal care constitutes irreparable harm “[g]iven the importance of this pre-natal care to the health of the fetus and the future health of the yet unborn child”).

9 Moreover, the Guidelines discourage parents from offering their embryonic children for adoption by perpetuating the myth that embryos are needed for promising medical re-[Footnote continued on next page]


Supp. Add. 45


38

Apart from the irreversible destruction of human embryos, the Guidelines would irrepar-

ably injure researchers who work exclusively with adult stem cells, like Drs. Sherley and Deish-

er, by illegally diverting scarce federal stem cell funding to embryonic stem cell research. By

putting adult stem cell researchers’ grant proposals in competition with those of embryonic stem

cell researchers, the Guidelines will make it more difficult for the former to obtain federal fund-

ing. (Decl. of Dr. James L. Sherley in Support of Pls.’ Mot. for Prelim. Inj., ¶¶ 3–4 (“Sherley

Decl.”); Decl. of Dr. Theresa Deisher in Support of Pls.’ Mot. for Prelim. Inj., ¶¶ 3–4 (“Deisher

Decl.”).) Under the Guidelines, embryonic stem cell research will absorb a significant propor-

tion of total federal stem cell research funding. Given the fixation on embryonic stem cell re-

search that the Guidelines reflect, those working on more promising adult stem cell research will

no doubt be deprived of opportunities for funding.

Importantly, those adult stem cell researchers will have no after-the-fact remedy for the

loss of this opportunity for federal funding. (Sherley Decl., at ¶ 4; Deisher Decl., at ¶ 3.) In the

absence of an adequate remedy, this loss constitutes irreparable injury. See Bracco Diagnostics,

Inc. v. Shalala, 963 F. Supp. 20, 28 (D.D.C. 1997) (finding irreparable harm where there is “no

adequate compensatory or other corrective relief” even though harm is economic in nature). But

beyond mere pecuniary loss, enforcement of the Guidelines will irreparably harm the research-


search. Without a preliminary injunction, many embryos will be destroyed as parents are misled into believing that there is a high moral purpose to donating embryos for research. As a result, Plaintiffs who wish to adopt (or place for adoption) these embryos will be ir-reparably injured. (Decl. of William T. Flynn in Support of Pls.’ Mot. for Prelim. Inj., ¶ 4; Decl. of Tina Nelson in Support of Pls.’ Mot. for Prelim. Inj., ¶ 4.; Decl. of Ronald L. Stoddart in Support of Pls.’ Mot. for Prelim. Inj., ¶ 6.)


Supp. Add. 46


39

ers’ personal and professional interests in pursuing their lifelong work while this Court considers

this case. (Sherley Decl., at ¶ 4; Deisher Decl., at ¶ 3.) For these reasons, they will suffer irre-

parable harm.

III. The Balance Of Hardships Heavily Favors Immediate Injunctive Relief

In light of the serious and irreparable harm that Plaintiffs would suffer without a prelimi-

nary injunction, the balance of hardships strongly favors immediate injunctive relief. As ex-

plained above, Plaintiffs’ reproductive choices, lives, and livelihoods will be lost if this Court

permits the Guidelines to go into effect during the pendency of their suit. These enduring inter-

ests far outweigh any negligible harm to Defendants’ interest in enforcing an ethically dubious

and scientifically unnecessary government policy during the few months needed to litigate this

case.

Neither Defendants nor any other entity will be substantially burdened by a preliminary

injunction in Plaintiffs’ favor. Federal funds have never before been used to incentivize the de-

struction of human embryos, and temporarily maintaining the status quo will not impose any

new burden on Defendants. On the contrary, a system for allocating federal stem cell research

funds—the system NIH has used since the current policy was developed in 2001—is already in

place. Moreover, embryonic stem cell researchers can continue to access non-federal funding for

their work, a prospect with which a preliminary injunction would not interfere.

Courts have been particularly willing to preserve the status quo through use of a prelimi-

nary injunction where, as here, the contemplated injunction will be of a “short duration.” Hoff-

man-Laroche, Inc. v. Califano, 453 F. Supp. 900, 903 (D.D.C. 1978). Because the core of this

case is a legal rather than a factual dispute, little discovery will be necessary before this Court

can proceed to judgment on the merits. Under these circumstances, “[i]ssuance of a preliminary


Supp. Add. 47


40

injunction especially one of the short duration contemplated here will not substantially harm de-

fendants.” Id.

IV. The Public Interest Favors A Preliminary Injunction

The public interest strongly favors a preliminary injunction in this case. In passing the

Dickey-Wicker Amendment, Congress necessarily mandated that the public interest would be

served by preventing taxpayer funding of research that entails the destruction of human embryos.

It is well-established that “[i]t is in the public interest for courts to carry out the will of Congress

and for an agency to implement properly the statute it administers.” Mylan Pharm., Inc., v. Sha-

lala, 81 F. Supp. 2d 30, 45 (D.D.C. 2000). By vindicating Congress’s prohibition of research

that entails the destruction of human embryos, a preliminary injunction will serve the public in-

terest.

Moreover, a preliminary injunction will serve the public interest by preventing a wasteful

diversion of public funds to needless and relatively unpromising research. Because the Guide-

lines will divert funds from a more promising type of research and perpetuate popular miscon-

ceptions about the science of embryonic stem cells, a preliminary injunction will serve the inter-

est of the public.

Finally, a preliminary injunction will also serve the public’s interest by withholding tax-

payer dollars from a type of research that many taxpayers and States recognize to be ethically

and morally troubling. The laws of numerous States protect human life from the moment of

conception or otherwise protect human embryos from being destroyed for the purpose of medical

experimentation. The public interest is disserved by federal funding of an immoral and unneces-

sary research method.


Supp. Add. 48



Supp. Add. 49



Supp. Add. 50



The undersigned does hereby certify that a true and accurate copy of the foregoing Mo-

tion for Preliminary Injunction, Memorandum of Law in Support of Plaintiffs' Motion for Pre-

liminary Injunction and Declarations of William T. Flynn, Dr. James Sherley, Dr. Theresa

Deisher, Mrs. Tina Nelson, Ronald L. Stoddart and Bradley J. Lingo, and Proposed Order was

served by Certified United States Mail, postage prepaid, this 19th day of August, 2009, upon the

following:

Kathleen SebeliusSecretary, Department of Health and Human Services200 Independence Avenue, S.W.Bethesda, MD 20892

Dr. Francis CollinsDirector, National Institutes of Health9000 Rockville PikeBethesda, MD 20892

The Honorable Eric HolderUnited States Attorney GeneralU.S. Department of Justice950 Pennsylvania Avenue, N.W.Washington, DC 20530-0001

Channing D. PhillipsActing United States Attorney555 4th Street, NWWashington, DC 20530

3


Supp. Add. 51



DR. JAMES L. SHERLEY, et al., Plaintiffs,

))))))))

v. )))

Civil Action No. 09-CV-01575-RCL


Defendants.

)))))))))

PLAINTIFFS’ MOTION FOR SUMMARY JUDGMENT

Thomas G. Hungar, D.C. Bar No. 447783 Bradley J. Lingo, D.C. Bar No. 490131 Thomas M. Johnson, Jr., D.C. Bar No. 976185 GIBSON, DUNN & CRUTCHER LLP 1050 Connecticut Avenue, N.W. Washington, D.C. 20036 (202) 955-8500 Blaine H. Evanson, Cal. Bar No. 254338 Andrew G. Pappas, Cal. Bar No. 266409 Michelle K. Pulley, Cal. Bar No. 266865 GIBSON, DUNN & CRUTCHER LLP 333 S. Grand Avenue Los Angeles, CA 90071 (213) 229-7000



Supp. Add. 52


Plaintiffs, through undersigned counsel, respectfully move this Court for summary

judgment pursuant to Fed. R. Civ. P. 56 vacating and declaring invalid the National Institutes of

Health’s Guidelines for Human Stem Cell Research (“Guidelines”) and permanently enjoining

further implementation of the Guidelines. A Memorandum of Points and Authorities, Plaintiffs’

Statement of Material Facts As To Which There Is No Genuine Dispute, and a Proposed Order

are submitted herewith pursuant to LCvR 7(h) and 56.1.

In view of the fact that the issues were addressed in the oral argument on Plaintiffs’

Motion for Preliminary Injunction, the Court may conclude that further oral argument is not

necessary on this motion, but Plaintiffs would be pleased to participate in oral argument if it

would be of assistance to the Court.

Dated: September 9, 2010 Samuel B. Casey, Cal. Bar No. 76022 ADVOCATES INTERNATIONAL 9691 Main Street, Suite D Fairfax, VA 22031 (703) 894-1076 Steven H. Aden, D.C. Bar No. 466777 ALLIANCE DEFENSE FUND 801 G. Street N.W., Suite 509 Washington, D.C. 20001 (202) 393-8690

Respectfully Submitted, /s/ Thomas G. Hungar _ Thomas G. Hungar, D.C. Bar No. 447783 Bradley J. Lingo, D.C. Bar No. 490131 Thomas M. Johnson, Jr., D.C. Bar No. 976185 GIBSON, DUNN & CRUTCHER LLP 1050 Connecticut Avenue, N.W. Washington, D.C. 20036 (202) 955-8500 Blaine H. Evanson, Cal. Bar No. 254338 Andrew G. Pappas, Cal. Bar No. 266409 Michelle K. Pulley, Cal. Bar No. 266865 GIBSON, DUNN & CRUTCHER LLP 333 South Grand Avenue Los Angeles, CA 90071 (213) 229-7000


Supp. Add. 53



I hereby certify that on this 9th day of September, 2010, I electronically filed the foregoing Motion for Summary Judgment, and accompanying Memorandum of Law in Support, Statement of Material Facts, and related exhibits, with the Clerk of the United States District Court for the District of Columbia by using the CM/ECF system.

Service was also accomplished on the following by email and First Class U.S. Mail:

Eric R. Womack [email protected] Joel L. McElvain [email protected] Kyle Renee Freeny [email protected] Tamra Tyree Moore [email protected] U.S. Department of Justice 20 Massachusetts Avenue, NW Washington, DC 20001

/s/ Thomas M. Johnson, Jr. Thomas M. Johnson, Jr.


Supp. Add. 54




)))))

v. ))) ) )



Defendants.

))))))

MEMORANDUM OF LAW IN SUPPORT OF

PLAINTIFFS’ MOTION FOR SUMMARY JUDGMENT

Thomas G. Hungar, D.C. Bar No. 447783 Bradley J. Lingo, D.C. Bar No. 490131 Thomas M. Johnson, Jr., D.C. Bar No. 976185 GIBSON, DUNN & CRUTCHER LLP 1050 Connecticut Avenue, N.W. Washington, D.C. 20036 (202) 955-8500 Blaine H. Evanson, Cal. Bar No. 254338 Andrew G. Pappas, Cal. Bar No. 266409 Michelle K. Pulley, Cal. Bar No. 266865 GIBSON, DUNN & CRUTCHER LLP 333 S. Grand Avenue Los Angeles, CA 90071 (213) 229-7000



Supp. Add. 55


TABLE OF CONTENTS

Page

INTRODUCTION ...........................................................................................................................1

BACKGROUND .............................................................................................................................2

I. The Dickey-Wicker Amendment.....................................................................................2

II. The Promulgation of the Guidelines ................................................................................3

III. Advances in Non-Embryonic Stem Cell Research ..........................................................5

A. Embryonic Stem Cell Research ...........................................................................6

B. Adult Stem Cell Research....................................................................................6

C. Induced Pluripotent Stem Cell Research .............................................................7

IV. NIH’s Funding Process ....................................................................................................8

V. The Present Action...........................................................................................................9

ARGUMENT.................................................................................................................................11

I. Standard of Review........................................................................................................11

II. Standing .........................................................................................................................12

III. The Guidelines Violate the Dickey-Wicker Amendment, and Summary Judgment Therefore Should be Entered for Plaintiffs ...................................................13

A. The Dickey-Wicker Amendment Plainly Prohibits Federal Funding of All Research in Which Human Embryos Are Destroyed ..............................13

1. The Guidelines Authorize Funding for “Research in Which” Embryos Will Be Destroyed or Knowingly Subjected to Risk of Injury or Death .....................................................14

(a) Defendants’ Derivation/Use Distinction Has No Basis in the Text or Structure of the Dickey-Wicker Amendment................................................................................14

(b) Defendants’ Counsel’s “Piece of Research” Interpretation Defies the Statutory Text, Conflicts with Defendants’ Interpretation Outside This

i


Supp. Add. 56


TABLE OF CONTENTS (continued)

Page

ii

Litigation, and Ignores the Context in Which Dickey-Wicker Was Enacted.....................................................15

(c) The Guidelines Violate Dickey-Wicker Because They Knowingly Subject Human Embryos to Risk of Death or Injury by Incentivizing the Destruction of Additional Embryos...............................................................19

(d) Dickey-Wicker’s Ambiguous Legislative History Cannot Eclipse the Unambiguous Statutory Text......................20

2. No Deference Is Due Defendants’ Interpretation of Dickey-Wicker’s Unambiguous Terms ..............................................................22

IV. Defendants Promulgated the Guidelines in Violation of the Administrative Procedure Act.................................................................................................................25

A. Defendants’ Promulgation of the Guidelines Was Arbitrary and Capricious and Violated Procedures Required by Law. ....................................26

B. Defendants Entered the Comment Period with an Unalterably Closed Mind.......................................................................................................31

C. The Executive Order Did Not and Could Not Exempt Defendants from the Requirements of the APA ...................................................................33

1. The President Did Not Direct Defendants to Fund Embryonic Stem Cell Research and Therefore Defendants Violated the APA by Failing to Explain Why They Rejected Comments with Categorical Objections to Such Funding ..................................................................................................33

2. The President Cannot Authorize Agencies to Disregard the Requirements of the APA ......................................................................35

V. Permanent Injunctive Relief Is Necessary and Appropriate. .........................................37

A. Plaintiffs Can Show Actual Success on the Merits............................................38

B. Equitable Considerations Support Permanent Injunctive Relief. ......................38

1. Plaintiffs Would Suffer Irreparable Harm Absent a Permanent Injunction .............................................................................39


Supp. Add. 57


TABLE OF CONTENTS (continued)

Page

iii

2. The Balance of the Hardships Supports Permanent Injunctive Relief.....................................................................................41

3. Permanent Injunctive Relief Would Serve the Public Interest....................................................................................................42

CONCLUSION..............................................................................................................................43


Supp. Add. 58



Page(s)

Cases

* ACLU v. Mineta, 319 F. Supp. 2d 69 (D.D.C. 2004) ............................................................................. 37, 38

Action on Smoking & Health v. Civil Aeronautics Bd., 699 F.2d 1209 (D.C. Cir. 1983) ........................................................................................ 29

Alarm Indus. Commc’ns Comm. v. F.C.C., 131 F.3d 1066 (D.C. Cir. 1997) ........................................................................................ 25

Ali v. Fed. Bureau of Prisons, 514 U.S. 214 (2008).......................................................................................................... 15

Am. Equity Inv. Life Ins. Co. v. SEC, 572 F.3d 923 (D.C. Cir. 2009) .......................................................................................... 30

* Am. Mining Cong. v. EPA, 907 F.2d 1179 (D.C. Cir. 1990) .................................................................................. 26, 30

Amoco Prod. Co. v. Vill. of Gambell, 480 U.S. 531 (1987) ......................................................................................................... 38

Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (1986).................................................................................................... 11, 12

Arkansas v. Oklahoma, 503 U.S. 91 (1992)............................................................................................................ 30

* Ass’n of Nat’l Advertisers, Inc. v. FTC, 627 F.2d 1151 (D.C. Cir. 1979) ........................................................................................ 31

Bowen v. Georgetown Univ. Hosp., 488 U.S. 204 (1988).................................................................................................... 24, 31

Burlington Truck Lines v. United States, 371 U.S. 156 (1962).......................................................................................................... 25

Carter v. United States, 530 U.S. 255 (2000).......................................................................................................... 21

Celotex Corp. v. Catrett, 477 U.S. 317 (1986).......................................................................................................... 11

Chamber of Commerce of the U.S. v. Reich, 74 F.3d 1322 (1996).......................................................................................................... 36

Chevron U.S.A., Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837 (1984).......................................................................................................... 22

City of Kansas City v. Dep’t of Hous. & Urban Dev., 923 F.2d 188 (D.C. Cir. 1991) .......................................................................................... 24

iv


Supp. Add. 59


TABLE OF AUTHORITIES (continued)

Page(s)

v

Cobell v. Kempthorne, 455 F.3d 301 (D.C. Cir. 2006) ......................................................................................... 42

Crowley v. Fed. Bureau of Prisons, 312 F. Supp. 2d 453 (S.D.N.Y. 2004)............................................................................... 24

Davis v. Mich. Dep’t of Treasury, 489 U.S. 803 (1989).......................................................................................................... 20

Dep’t of Hous. & Urban Dev. v. Rucker, 535 U.S. 125 (2002).......................................................................................................... 20

Diamond v. Atwood, 43 F.3d 1538 (D.C. Cir. 1995) .......................................................................................... 12

First Am. Bank, N.A. v. United Equity Corp., 89 F.R.D. 81 (D.D.C. 1981).............................................................................................. 11

Fort Stewart Schs. v. Fed. Labor Relations Auth., 495 U.S. 641 (1990).......................................................................................................... 31

Gen. Dynamics Land Sys., Inc. v. Cline, 540 U.S. 581 (2004).......................................................................................................... 22

H.A.L. v. Foltz, 551 F.3d 1227 (11th Cir. 2008) ........................................................................................ 19

Harbor Gateway Commercial Prop. Owners Ass’n v. EPA, 167 F.3d 602 (D.C. Cir. 1999) .......................................................................................... 18

Hartford Underwriters Ins. Co. v. Union Planters Bank, N.A., 530 U.S. 1 (2000).............................................................................................................. 14

Home Box Office, Inc. v. FCC, 567 F.2d 9 (D.C. Cir. 1977) .............................................................................................. 30

Indep. Bankers Ass’n of Am. v. Smith, 534 F.2d 921 (D.C. Cir. 1976) ................................................................................... 39, 42

* Int’l Ladies’ Garment Workers’ Union v. Donovan, 722 F.2d 795 (D.C. Cir. 1983) .......................................................................................... 30

Lamie v. U.S. Trustee, 540 U.S. 526 (2004).......................................................................................................... 21

Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005).................................................................................................... 16, 17

Milavetz, Gallop & Milavetz v. United States, 130 S. Ct. 1324 (2010)...................................................................................................... 21

* Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto Ins. Co., 463 U.S. 29 (1983)...................................................................................................... 25, 30


Supp. Add. 60



Page(s)

vi

Mylan Pharms., Inc. v. Shalala, 81 F. Supp. 2d 30 (D.D.C. 2000) ...................................................................................... 42

Nat’l Ass’n of Mfrs. v. Taylor, 582 F.3d 1 (D.C. Cir. 2009) .............................................................................................. 21

Nat’l Ass’n of Psychiatric Health Sys. v. Shalala, 120 F. Supp. 2d 33 (D.D.C. 2002) ................................................................................... 37

Nat’l Ctr. for Mfg. Scis., Inc. v. City of Ann Arbor, 563 N.W.2d 65 (Mich. Ct. App. 1997) ............................................................................. 17

Nat’l Mining Ass’n v. U.S. Army Corps of Eng’rs, 145 F.3d 1399 (D.C. Cir. 1998) ....................................................................................... 38

Nat’l R.R. Passenger Corp. v. Boston & Maine Corp., 503 U.S. 407 (1992).......................................................................................................... 23

Natural Res. Def. Council, Inc. v. EPA, 683 F.2d 752 (3d Cir. 1982).............................................................................................. 35

* Nehemiah Corp. of Am. v. Jackson, 546 F. Supp. 2d 830 (E.D. Cal. 2008)............................................................................... 32

Penn. Protection & Advocacy, Inc. v. Houston, 228 F.3d 423 (3d Cir. 2000).............................................................................................. 22

Peter Pan Bus Lines, Inc. v. Fed. Motor Carrier Safety Admin., 471 F.3d 1350 (D.C. Cir. 2006) .................................................................................. 24, 34

Pub. Citizen, Inc. v. Dep’t of Health & Human Servs., 332 F.3d 654 (D.C. Cir. 2003) .................................................................................... 23, 24

Russello v. United States, 464 U.S. 16 (1983)............................................................................................................ 15

SEC v. Chenery Corp., 318 U.S. 80 (1943)...................................................................................................... 30, 31

* Sherley v. Sebelius, 610 F.3d 69 (D.C. Cir. 2010) ........................................................................ 8, 9, 10, 11, 12

Sherley v. Sebelius, 686 F. Supp. 2d 1 (D.D.C. 2009) ...................................................................................... 10

Skidmore v. Swift & Co., 323 U.S. 134 (1944).......................................................................................................... 25

Soucie v. David, 448 F.2d 1067 (D.C. Cir. 1971) ........................................................................................ 36

U.S. Telecom Ass’n v. FCC, 227 F.3d 450 (D.C. Cir. 2000) .......................................................................................... 30


Supp. Add. 61



Page(s)

vii

United States ex rel. Totten v. Bombardier Corp., 380 F.3d 488 (D.C. Cir. 2004) .......................................................................................... 20

* United States v. Mead Corp., 533 U.S. 218 (2001).................................................................................................... 23, 25

United States v. Rodgers, 461 U.S. 677 (1983).......................................................................................................... 33

Statutes

5 U.S.C. § 706(2)(A)....................................................................................................................... 9

5 U.S.C. § 706(2)(D)..................................................................................................................... 30

Balanced Budget Downpayment Act, I, Pub. L. No. 104-99, § 128, 110 Stat. 26 (1996).................................................................. 2

* Consolidated Appropriations Act, 2010, Pub. L. No. 111-117, § 509(a)(2), 123 Stat. 3034 ............................ 1, 2, 13, 14, 16, 17, 19

Other Authorities

Bernadine Healy, M.D., Why Embryonic Stem Cells Are Obsolete, U.S. News & World Report, Mar. 4, 2009, available at http://health.usnews.com/blogs/ heart-to-heart/2009/03/04/why-embryonic-stem-cells-are-obsolete.html .......................... 6

Dep’t of Health & Human Servs., Guidance on Engagement of Institutions in Human Subjects Research (Oct. 16, 2008), available at http://www.hhs.gov/ohrp/humansubjects/ guidance/engage08.html ................................ 16

Gautam Naik, NIH Offers Rules for Embryonic Stem Cell Research, Wall St. J., Apr. 17, 2009.................................................................................................. 32

Gretchen Vogel, Breakthrough of the Year: Reprogramming Cells, 322 Science 1766 (2008) .................................................................................................... 7

Jeffrey Young, Administration Unveils Stem Cell Rules, The Hill, July 6, 2009, available at http://thehill.com/homenews/administration/49462-administration-unveils-stem-cell-rules ............................................................................... 4

Nat’l Bioethics Advisory Comm’n, 1 Ethical Issues in Human Stem Cell Research 53 (Sept. 1999).................................................................................................................. 29

Nat’l Institutes of Health, Funding for Research, http://stemcells.nih.gov/research/ funding/defaultpage.asp (last visited Aug. 28, 2010) ......................................................... 8

Nat’l Institutes of Health, Listing of Comments on Draft NIH Human Stem Cell Guidelines, http://grants.nih.gov/stem_cells/web_listing.htm?)................................... 4, 25

Nat’l Institutes of Health, Office of the Director, Notice of Criteria for Federal Funding of Research on Existing Human Embryonic Stem Cells and Establishment of NIH Human Embryonic Stem Cell Registry NOT-OD-02-


Supp. Add. 62



Page(s)

viii

005 (Aug. 9, 2001), available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html ................................................................................................ 3

Nat’l Institutes of Health, Stem Cell Basics 14 (2009), available at http://stemcells.nih.gov/staticresources/info/basics/SCprimer2009.pdf............................. 8

President Barack Obama, Signing of Stem Cell Executive Order and Scientific Integrity Presidential Memorandum (Mar. 9, 2009), available at http://www.whitehouse.gov/the_press_office/Remarks-of-the-President-As-Prepared-for-Delivery-Signing-of-Stem-Cell-Executive-Order-and-Scientific-Integrity-Presidential-Memorandum................................................................ 27

Special Hearing on Stem Cell Research: Hearing before the Subcommittee on Labor, Health, and Education of the S. Comm. on Appropriations, 106 Cong. 9-10 (Nov. 4, 1999) ................................................................................................ 21

Statement of Sen. Specter, 145 Cong. Rec. S11585-07 (Sept. 29, 1999) .................................................................... 20

Rules

Fed. R. Civ. P. 56(a) ..................................................................................................................... 11

Fed. R. Civ. P. 56(c) ..................................................................................................................... 11

Regulations

45 C.F.R. § 46.102(d) ................................................................................................................... 16

65 Fed. Reg. 51,976 (Aug. 25, 2000).............................................................................................. 3

66 Fed. Reg. 57,107 (Nov. 14, 2001).............................................................................................. 3

74 Fed. Reg. 10,667 (Mar. 11, 2009)........................................................................ 3, 4, 26, 34, 35

74 Fed. Reg. 18,578 (Apr. 23, 2009) .............................................................................................. 4

74 Fed. Reg. 32,170 (July 7, 2009)........................... 1, 5, 11, 13, 14, 17, 18, 20, 23, 27, 29, 34, 35


Supp. Add. 63


INTRODUCTION

In the wake of this Court’s recent opinion and Order issuing a preliminary injunction in

this matter, the time is right for this Court to grant summary judgment in favor of the Plaintiffs’

claim that the National Institutes of Health Guidelines for Human Stem Cell Research (“NIH

Guidelines”) are invalid as a matter of law. The NIH Guidelines violate federal law, which

prohibits funding “research in which” a human embryo is “destroyed, discarded, or knowingly

subjected to risk of injury or death.” Consolidated Appropriations Act, 2010, Pub. L. No. 111-

117, § 509(a)(2), 123 Stat. 3034, 3280–81 (the “Dickey-Wicker Amendment”). Moreover, in

promulgating the Guidelines, NIH failed to explain how the funding of embryonic stem cell

research will fulfill the Guidelines’ stated purpose to support “ethically responsible” and

“scientifically worthy” research, and failed to address substantial evidence in the administrative

record showing that federal funding of such research will in fact have the opposite effect. See 74

Fed. Reg. 32,170 (July 7, 2009) (attached as Declaration of Steven H. Aden in Support of Pls.’

Mot. for Summary Judgment (“Aden Decl.”), Ex. C). Plaintiffs’ claims for declaratory and

injunctive relief can be resolved based on the undisputed facts and therefore are ready for

summary adjudication.

As this Court has already concluded, Plaintiffs’ claim under the Dickey-Wicker

Amendment presents a straightforward question of statutory interpretation—namely, whether

human embryonic stem cell research is “research in which a human embryo or embryos are

destroyed, discarded, or knowingly subjected to risk of injury or death.” The Dickey-Wicker

Amendment unambiguously precludes the funding of embryonic stem cell research under the

NIH Guidelines, because such research necessarily and inevitably involves the destruction of

human embryos. Plaintiffs’ Administrative Procedure Act (“APA”) claims are similarly

straightforward and ready for resolution. With respect to those claims, this Court must simply

1


Supp. Add. 64


decide whether NIH failed to offer a reasoned explanation for its sub silentio rejection of the

public comments and substantial evidence in the administrative record showing that the

Guidelines are categorically inconsistent with the agency’s stated goals and criteria.

BACKGROUND

I. The Dickey-Wicker Amendment

For more than a decade, Congress has explicitly banned federal funding of research in

which human embryos are destroyed or knowingly subjected to harm. In 1996, Congress first

enacted an appropriations rider that prohibits federal funding of research in which human

embryos are harmed or destroyed. That rider, commonly known as the Dickey-Wicker

Amendment, provides that: “(a) None of the funds made available in this Act may be used 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 injury or

death greater than that allowed for research on fetuses in utero . . . .” § 509(a)(2), 123 Stat. at

3280–81.

Congress has included the Dickey-Wicker Amendment in every Health and Human

Services (“HHS”) appropriations bill since 1996, and has not altered the Amendment in any

material respect. (SOF ¶ 17.) Congress thus continues to prohibit federal funding for “research

in which” an embryo is “destroyed, discarded, or knowingly subjected to risk of injury or death.”

And since Congress first enacted the Dickey-Wicker Amendment, no federal money had been

spent on research that entailed and encouraged the further destruction of human embryos—until

now.1

[Footnote continued on next page]

1 NIH attempted to fund human embryonic stem cell research in 2000 when it finalized and made effective “Guidelines for Research Using Human Pluripotent Stem Cells” (“2000

2


Supp. Add. 65


II. The Promulgation of the Guidelines

On March 9, 2009, President Obama signed Executive Order 13,505, which authorized

NIH to “support and conduct responsible, scientifically worthy human stem cell research,

including human embryonic stem cell research, to the extent permitted by law.” 74 Fed. Reg.

10,667 (Mar. 11, 2009) (attached as Aden. Decl., Ex. A); SOF ¶ 20. To that end, the Order

provided that “[w]ithin 120 days . . . [HHS and NIH] shall review existing NIH guidance and

other widely recognized guidelines on human stem cell research . . . and issue new NIH guidance

on such research that is consistent with [the] order.” 74 Fed. Reg. 10,667; SOF ¶ 20.

Six weeks later, Defendants issued a notice of proposed rulemaking (“NOPR”)

containing a proposed draft of the current Guidelines for human stem cell research (“Draft

Guidelines”). 74 Fed. Reg. 18,578 (Apr. 23, 2009) (attached as Aden Decl., Ex. B); SOF ¶ 22.

According to the NOPR, the Guidelines’ purpose would be to “ensure that NIH-funded research

[involving human embryonic stem cells] is ethically responsible, scientifically worthy, and

conducted in accordance with applicable law.” 74 Fed. Reg. 18,578; SOF ¶ 23. The NOPR


Guidelines”), 65 Fed. Reg. 51,976 (Aug. 25, 2000). (SOF ¶ 18.) Then-HHS General Counsel Harriet S. Rabb concluded in a memorandum (“Rabb Memorandum”), that embryonic stem cells are not “embryos” under the Dickey-Wicker Amendment, and therefore that NIH could legally fund experiments on the stem cells after those cells had been derived with private funds. (Aden Decl., Ex. E [Rabb Memorandum].) The Rabb Memorandum opined only on the definition of “embryos,” and said nothing about the scope of the word “research.” The 2000 Guidelines were never implemented, however, because in 2001 NIH formally withdrew those guidelines, see 66 Fed. Reg. 57,107 (Nov. 14, 2001); SOF ¶ 19, and issued new guidelines that allowed funding only for research involving already-derived stem cell lines derived no later than the August 9, 2001 date set by President Bush in the announcement of his policy regarding the funding of embryonic stem cell research. (Aden Decl., Ex. D at E-2 to E-3.) See also Nat’l Institutes of Health, Office of the Director, Notice of Criteria for Federal Funding of Research on Existing Human Embryonic Stem Cells and Establishment of NIH Human Embryonic Stem Cell Registry NOT-OD-02-005 (Aug. 9, 2001), available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.

3


Supp. Add. 66


proposed the authorization of federal funding of human embryonic stem cell research. 74 Fed.

Reg. 18,578; SOF ¶ 24. Defendants also invited public comment on the Draft Guidelines. 74

Fed. Reg. 18,578; SOF ¶ 22. It is undisputed that the notice-and-comment procedures set forth

in 5 U.S.C. § 553(c) governed Defendants’ promulgation of the Guidelines.

Defendants received 49,015 public comments (SOF ¶ 37; see Nat’l Institutes of Health,

Listing of Comments on Draft NIH Human Stem Cell Guidelines,

http://grants.nih.gov/stem_cells/web_listing.htm?), most of which opposed federal funding of

human embryonic stem cell research. (See SOF ¶ 38; Aden Decl., Ex. F [Jeffrey Young,

Administration Unveils Stem Cell Rules, The Hill, July 6, 2009, available at

http://thehill.com/homenews/administration/49462-administration-unveils-stem-cell-rules].)

Some of the comments addressed the numerous scientific and ethical flaws in federally funding

such research and documented the superior alternatives to it. (See SOF ¶¶ 26–28, 30–32; e.g.,

Aden Decl., Ex. D.) The comments also identified the serious risks associated with human

embryonic stem cell treatments, as well as the inherent limitations on those cells’ therapeutic

potential. (See SOF ¶ 28(y)–(ff); Aden Decl., Ex. D at I-1 to I-3.) The comments also detailed

the substantial and verifiable medical results already delivered by adult stem cells, and other

characteristics that render adult stem cells a superior scientific and ethical alternative. (See SOF

¶¶ 28(b)–(l), 32(d)–(g), 32(m)–(n); e.g., Aden Decl., Ex. D at G-2, G-6.) Defendants disregarded

these comments, however, because in Defendants’ view they “did not ask the public whether

[NIH] should fund research on human embryonic cells,” but rather “how [NIH] should fund

human embryonic stem cell research.” (SOF ¶ 38; Aden Decl., Ex. F (emphasis added).)

On July 7, 2009—only six weeks after the comment period closed—Defendants issued

the final Guidelines. 74 Fed. Reg. 32,170 (attached as Aden Decl., Ex. C); SOF ¶ 40. The

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Guidelines purport to implement the President’s Executive Order by authorizing the federal

funding of embryonic stem cell research utilizing live human embryos that were “created . . . for

reproductive purposes” but are “no longer needed for [that] purpose.” 74 Fed. Reg. at 32,170,

32,174; SOF ¶ 40. The Guidelines set forth the procedures by which live embryos must be

selected for destruction if they are to be used in government-funded research. See, e.g., 74 Fed.

Reg. at 32,174; SOF ¶¶ 41, 45.

III. Advances in Non-Embryonic Stem Cell Research

As noted above, many of the commenters on the Draft Guidelines explained that stem

cell research has the potential to treat a number of diseases that have long resisted traditional

methods. (See SOF ¶¶ 28(b); Aden Decl., Ex. D at 9–10.) Indeed, numerous adult stem cell

therapies already exist (e.g., bone marrow transplants used to treat leukemia). (See SOF ¶ 28(c);

Aden Decl., Ex. D at 9, G-1, G-4.) But, both scientifically and ethically, all stem cells are not

created equal. There are three general types of stem cells: embryonic, adult, and induced

pluripotent. (SOF ¶ 28(a).) Although embryonic stem cells have received much of the public

and media attention, no actual medical treatments have been approved using these cells. (See

SOF ¶¶ 28(z), 51; Aden Decl., Ex. D at G-1; id. at Ex. G [Bernadine Healy, M.D., Why

Embryonic Stem Cells Are Obsolete, U.S. News & World Report, Mar. 4, 2009, available at

http://health.usnews.com/blogs/heart-to-heart/2009/03/04/why-embryonic-stem-cells-are-

obsolete.html].) In contrast, scientists have made dramatic breakthroughs in the use of adult and

induced pluripotent stem cells, and these ethically unobjectionable research methods have

generated the vast majority of scientific progress, and all of the actual medical success stories

involving stem cells. (See SOF ¶ 28(c), (z); Aden Decl., Ex. D at G-1 to G-8, H-1 to H-4.)

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A. Embryonic Stem Cell Research

Human embryonic stem cells are found in the inner cell mass of a living human embryo.

(See SOF ¶ 50; see Aden Decl., Ex. D at E-3.) The removal of the inner cell mass generates the

embryonic stem cell, but in order to extract the stem cell, the human embryo must be destroyed.

(SOF ¶ 50; Aden Decl., Ex. D at 5, E-3.) Although many researchers predicted that embryonic

stem cell research would lead to the cure of diseases such as Parkinson’s, Alzheimer’s, and

diabetes, those predictions have not come to pass. (SOF ¶ 54; Aden Decl., Ex. G; see also Aden.

Decl., Ex. D at A-2.) Indeed, far from the miracle-working potential that some had forecasted,

research shows that embryonic stem cells would likely form tumors when injected into a

patient’s body. (SOF ¶ 28(aa)–(cc); Aden Decl., Ex. D at I-2 to I-3.) And because the cells do

not come from the patient, they would likely be rejected by a patient’s immune system. (See

SOF ¶ 28(ee); Aden Decl., Ex. D at G-8.)

B. Adult Stem Cell Research

Adult stem cells are cells found in the body and in tissues normally discarded after birth

(such as umbilical cord blood and the placenta) that have the potential to generate most or all of

the different tissues in the human body. (SOF ¶ 28(d); Aden Decl., Ex. D at 9.) And—unlike

embryonic stem cells—adult stem cells have demonstrated great therapeutic promise. (SOF

¶ 28(b)–(c); Aden Decl., Ex. D at G-1.) As former NIH head Dr. Bernadine Healy observed

early last year, adult stem cells “have become stars,” representing “most of the stem cell

triumphs that the public hears about.” (Aden Decl., Ex. G. at 2.) In fact, adult stem cells have

verifiably treated countless individuals suffering from a wide variety of diseases, including

ovarian cancer, retinoblastoma, brain tumors, testicular cancer, chronic and acute leukemias,

breast cancer, renal cell carcinoma, anemias, Crohn’s disease, rheumatoid arthritis, and juvenile

diabetes. (SOF ¶ 28(c); Aden Decl., Ex. D at G-4 to G-6.) Adult stem cells also have shown an

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ability to home in on damaged tissue, allowing the development of minimally invasive

administration techniques. (SOF ¶ 28(j); Aden Decl., Ex. D at G-8.) And whereas embryonic

stem cells pose serious risks of tumor formation and immune-rejection by the patient’s body,

adult stem cells present neither of these problems. (SOF ¶ 28(k); Aden Decl., Ex. D at G-8.)

C. Induced Pluripotent Stem Cell Research

Induced pluripotent stem cells are produced by genetically reprogramming mature cells

such that they are virtually indistinguishable from embryonic stem cells. (SOF ¶ 28(o); Aden

Decl., Ex. D at H-1 to H-2; see also SOF ¶ 63.) The process of producing human induced

pluripotent stem cells was invented just two years ago. (SOF ¶ 28(p); Aden Decl., Ex. D at H-1.)

This marked a dramatic leap forward in developmental biology, and was hailed by the journal

Science as the leading scientific breakthrough in any field in 2008. (Aden Decl., Ex. H

[Gretchen Vogel, Breakthrough of the Year: Reprogramming Cells, 322 Science 1766 (2008)].)

Induced pluripotent cells “meet the defining criteria [that were] originally proposed for human

[embryonic stem] cells, with the significant exception that the [induced pluripotent stem] cells

are not derived from embryos.” (SOF ¶ 28(w); Aden Decl., Ex. D at H-3.) And NIH has

recognized that, unlike embryonic stem cells, “tissues derived from [induced pluripotent stem

cells] will be a nearly identical match to the cell donor and thus probably avoid rejection by the

immune system.” Nat’l Institutes of Health, Stem Cell Basics 14 (2009), available at

http://stemcells.nih.gov/staticresources/info/basics/SCprimer2009.pdf; see SOF ¶ 64. Induced

pluripotent cells thus offer the same benefits as embryonic stem cells without the immune-

rejection risks to patients or, what is more, the ethical problems entailed in destroying human

embryos in order to obtain embryonic stem cells for research or therapeutic purposes. (SOF

¶¶ 28(m)–(n), (w); Aden Decl., Ex. D at 10, H-4.)

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IV. NIH’s Funding Process

Applicants for NIH research funding undergo a competitive two-tier peer review process.

Sherley v. Sebelius, 610 F.3d 69, 73 (D.C. Cir. 2010) (attached as Aden. Decl., Ex. N); SOF ¶¶ 3,

9; see also Aden Decl., Ex. J [Decl. of Sarah Jean Rockey, Ph.D., in Support of Defs.’ Opp’n to

Pls.’ Mot. for Prelim. Inj.] ¶¶ 8–12.2 At the first stage, “a peer-review committee assigns a

preliminary score to each grant application.” Sherley, 610 F.3d at 73; see also SOF ¶ 6; Aden

Decl., Ex. J ¶ 11. An application that scores above the median “then goes to one or more of the

24 Institutes and Centers (ICs) at the NIH.” Sherley, 610 F.3d at 73; see also SOF ¶ 6; Aden

Decl., Ex. J ¶ 9. At the second stage of the grant application process, “each IC decides which

grant applications to fund.” Sherley, 610 F.3d at 73; see also SOF ¶ 7.

Embryonic and adult stem cell researchers compete for the same funding. Each IC “has

its own budget and awards grants to projects that address its particular mission,” id.; see also

SOF ¶ 5; Aden Decl., Ex. J ¶ 5, including both adult and embryonic stem cell research (see SOF

¶ 5(c); Aden Decl., Ex. J ¶¶ 16–18). NIH funding is a zero-sum game. “[T]he amount of money

[presently] available from NIH for research grants is fixed notwithstanding the greater range of

stem cell research projects made eligible for funding by the Guidelines.” Sherley, 610 F.3d at

73. And because the Guidelines “will elicit an increase in the number of grant applications

involving” human embryonic stem cells, the Guidelines have thus “intensified the competition

for a share in a fixed amount of money.” Id. at 74; SOF ¶ 10.

2 In addition to accepting grant applications, NIH “encourages research in areas of top priority (such as stem cell research) by publishing [Program Announcements], [Requests for Applications], and [Requests for Proposals].” Nat’l Institutes of Health, Funding for Research, http://stemcells.nih.gov/research/ funding/defaultpage.asp (last visited Aug. 28, 2010). These “targeted” announcements are used “to stimulate research in particular areas of science.” (SOF ¶ 8; Aden Decl., Ex. J ¶ 6.)

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V. The Present Action

Dr. James L. Sherley3 and Dr. Theresa Deisher4 (“Plaintiffs”), among others, brought

this action against Defendants alleging that the Guidelines are not in accordance with law and

arbitrary and capricious within the meaning of the Administrative Procedure Act, 5 U.S.C.

§ 706(2)(A). Plaintiffs also allege that Defendants promulgated the Guidelines without

observing procedures required by law within the meaning of 5 U.S.C. § 706(2)(D). Plaintiffs

moved for a preliminary injunction restraining Defendants from implementing, applying, or

taking any action pursuant to the Guidelines. (Pls.’ Mot. for Prelim. Inj., Aug. 19, 2009 [Docket

(“Dkt.”) #3].)

are

Defendants opposed Plaintiffs’ motions and filed a motion to dismiss, which this Court

granted on the ground that, in its view, Plaintiffs lacked standing. Sherley v. Sebelius, 686 F.

Supp. 2d 1, 3 (D.D.C. 2009). The Court then denied as moot Plaintiffs’ motion for a preliminary

injunction. (Order of Oct. 27, 2009 [Dkt. #37].)

3 Dr. Sherley is an adult stem cell researcher who currently works at the Boston Biomedical Research Institute. (SOF ¶¶ 1 & 1(a); Declaration of Dr. James L. Sherley in Support of Pls.’ Mot. for Summary Judgment (“Sherley Decl.”) ¶ 2.) Dr. Sherley does not conduct research on human embryos or use human embryonic stem cells. (SOF ¶ 1(b); Sherley Decl. ¶ 2) He relies exclusively on research grants for funding, and most of the grants he receives are from NIH. (SOF ¶ 1(c); Sherley Decl. ¶ 3.) Dr. Sherley will continue to apply for NIH grants in the future, without which he would be unlikely to be able to continue his research. (SOF ¶ 1(i)-(j); Sherley Decl. ¶ 5.)

4 Dr. Deisher is an adult stem cell researcher and is the founder, managing member, and research and development director of AVM Biotechnology. (SOF ¶ 2 & 2(a); Declaration of Dr. Theresa Deisher in Support of Pls.’ Mot. for Summary Judgment (“Deisher Decl.”) ¶¶ 2-3.) Dr. Deisher does not conduct research on embryos or use embryonic stem cells. (SOF ¶ 2(c); Deisher Decl. ¶ 2.) She can continue her research only if she obtains funding from NIH, for which she is in the process of applying and which she will continue to seek. (SOF ¶ 2(d)-(e); Deisher Decl. ¶ 3.)

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Plaintiffs appealed, and prevailed on the issue of whether they have standing to bring this

action. The D.C. Circuit held that Plaintiffs have standing under the competitor-standing

doctrine. Sherley, 610 F.3d at 70. The Court of Appeals’s reasoning was not premised on any

disputed facts, but rather flowed logically from its explication of the competitor-standing

doctrine and the basic laws of economics. The Court explained that “the basic requirement

common to all [the court’s] cases is that the complainant [must] show an actual or imminent

increase in competition, which increase [the court] recognize[s] will almost certainly cause an

injury in fact.” Id. at 73 (emphasis added). The Court continued, “[t]here can be no doubt that

the Guidelines will elicit an increase in the number of grant applications involving [embryonic

stem cells] . . . . Because the Guidelines have intensified the competition for a share in a fixed

amount of money, the plaintiffs will have to invest more time and resources to craft a successful

grant application. That is an actual, here-and-now injury.” Id. at 74. The Court further

explained that Plaintiffs “will suffer an additional injury whenever a project involving

[embryonic stem cells] receives funding that, but for the broadened eligibility in the Guidelines,

would have gone to fund a project of theirs . . . . Although no one can say exactly how likely the

[Plaintiffs] are to lose funding to projects involving [embryonic stem cells], having been put into

competition with those projects, the [Plaintiffs] face a substantial enough probability to deem the

injury to them imminent.” Id.

Having determined that Plaintiffs have standing, the D.C. Circuit also reversed this

Court’s order dismissing as moot Plaintiffs’ motion for a preliminary injunction, and ordered that

motion reinstated. Id. at 75. On remand, this Court granted Plaintiffs’ motion for a preliminary

injunction, ordering “that defendants and their officers, employees, and agents are enjoined from

implementing, applying, or taking any action whatsoever pursuant to the National Institutes of

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Health Guidelines for Human Stem Cell Research, 74 Fed. Reg. 32,170 (July 7, 2009), or

otherwise funding research involving human embryonic stem cells as contemplated in the

Guidelines.” Order of Aug. 23, 2010 [Dkt. #45]. Defendants moved to stay the Court’s order

[Dkt. #48], but the Court denied that motion, Order of Sept. 7, 2010 [Dkt. #53]. In the interests

of judicial economy and a swift final resolution of this case, and because no genuine issue of

material fact exists and Plaintiffs are entitled to judgment as a matter of law on their claims

under both the Dickey-Wicker Amendment and the APA, Plaintiffs now move for summary

judgment on their claims for declaratory and injunctive relief.

ARGUMENT

I. Standard of Review

Either party may move for summary judgment at any time, even as early as the

commencement of the action and before the defendant has answered the complaint. Fed. R. Civ.

P. 56(a), (c)(1)(A), advisory committee’s note. See also First Am. Bank, N.A. v. United Equity

Corp., 89 F.R.D. 81, 87 (D.D.C. 1981) (“[A]n answer to the complaint is not a prerequisite to the

consideration of a motion for summary judgment.”). Summary judgment is proper “if the

pleadings, the discovery and disclosure materials on file, and any affidavits show that there is no

genuine issue as to any material fact and that the movant is entitled to judgment as a matter of

law.” Fed. R. Civ. P. 56(c)(2); Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986); Anderson v.

Liberty Lobby, Inc., 477 U.S. 242, 247 (1986); Diamond v. Atwood, 43 F.3d 1538, 1540 (D.C.

Cir. 1995). “By its very terms, [Rule 56(c)] provides that the mere existence of some alleged

factual dispute between the parties will not defeat an otherwise properly supported motion for

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summary judgment; the requirement is that there be no genuine issue of material fact.”

Anderson, 477 U.S. at 247–48.5

II. Standing

The question of Plaintiffs’ standing has been resolved by the D.C. Circuit’s opinion. See

Sherley, 610 F.3d 69 (attached as Aden. Decl., Ex. N). As Plaintiffs reaffirmed in their recent

declarations, the facts in the case have not changed. (Compare Sherley Decl., Deisher Decl. with

Aden Decl., Exs. L–N.) Plaintiffs continue to work primarily with adult stem cells, and continue

to seek research funding from NIH. (SOF ¶¶ 1 & 1(b), 2(b); Sherley Decl. ¶¶ 2, 5; Deisher Decl.

¶¶ 2–3.) And it remains “uncontested that, at least in the short run, the amount of money

available from NIH for research grants is fixed notwithstanding the greater range of stem cell

research projects made eligible for funding by the Guidelines.” Sherley, 610 F.3d at 73; SOF

¶ 5(d). As a result, Plaintiffs continue to suffer the “actual, here-and-now injury” of “intensified

competition for a share in a fixed amount of money,” and continue to face the “additional,”

“imminent” injury of losing funding when grants are awarded to human embryonic stem cell

researchers that, but for the Guidelines, would have been awarded to Plaintiffs. Sherley, 610

F.3d at 74. These facts are not in dispute, and the Court of Appeals has clearly held that they are

sufficient to confer both Article III and prudential standing on Plaintiffs. Id. at 74–75.

5 Plaintiffs are entitled to both declaratory and injunctive relief. Plaintiffs have clearly satisfied the requirements of 28 U.S.C. § 2201 that (1) “a case of actual controversy” exists, and (2) that case comes within the court’s jurisdiction. Id. § 2201(a); see also Tierney v. Schweiker, 718 F.2d 449, 456-57 (D.C. Cir. 1983). And as set forth in Section V below, Plaintiffs have shown they are entitled to a permanent injunction.

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III. The Guidelines Violate the Dickey-Wicker Amendment, and Summary Judgment Therefore Should be Entered for Plaintiffs

As the Court has already explained (Dkt. #44, at 10), the NIH Guidelines violate the

unambiguous terms of the Dickey-Wicker Amendment, which forbids federal funding of

“research in which a human embryo or embryos are destroyed, discarded, or knowingly

subjected to risk of injury or death.” § 509(a)(2), 123 Stat. at 3280–81. Human embryonic stem

cell research necessarily entails the destruction of human embryos. (SOF ¶¶ 45(c), 50; Aden

Decl., Ex. D at E-3; Dkt. #44, at 12 (“To conduct ESC research, ESCs must be derived from an

embryo. The process of deriving ESCs from an embryo results in the destruction of the

embryo.”).) This fact cannot be disputed, and indeed is recognized in the text of the Guidelines:

They set forth the very procedures by which live embryos must be selected for destruction for

purposes of government-funded research. See 74 Fed. Reg. at 32,170, 32,174; SOF ¶¶ 41, 45. In

the face of these regulations, NIH cannot plausibly contend that the embryonic stem cell research

that it funds is separate and distinct from the destruction of human embryos. Because it is

undisputed that human embryonic stem cell research causes injury to and the destruction of

human embryos, the Guidelines plainly violate the statute by authorizing the funding of such

research.

A. The Dickey-Wicker Amendment Plainly Prohibits Federal Funding of All Research in Which Human Embryos Are Destroyed

The Dickey-Wicker Amendment provides that “[n]one of the funds made available in this

Act may be used 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 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)).” § 509(a)(2), 123 Stat. at 3280–81. “Congress says in a statute what it means and

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means in a statute what it says there,” Hartford Underwriters Ins. Co. v. Union Planters Bank,

N.A., 530 U.S. 1, 6 (2000) (internal quotation marks omitted), and Dickey-Wicker

unambiguously prohibits the federal funding of research—such as embryonic stem cell

research—that requires and induces the destruction of human embryos. Despite their best

efforts, Defendants cannot reconcile the Guidelines with Dickey-Wicker’s unambiguous

command. Summary judgment must therefore be entered for Plaintiffs.

1. The Guidelines Authorize Funding for “Research in Which” Embryos Will Be Destroyed or Knowingly Subjected to Risk of Injury or Death

(a) Defendants’ Derivation/Use Distinction Has No Basis in the Text or Structure of the Dickey-Wicker Amendment

As an initial matter, NIH asserted in the Guidelines that Dickey-Wicker’s funding ban

applies only to the act of deriving stem cells from embryos, not to subsequent experiments on

those cells, because embryonic stem cells “are not embryos as defined by Section 509.” 74 Fed.

Reg. at 32,173 (attached as Aden Decl., Ex. C). But that proposition does not resolve the

statutory issue, because the statute’s text prohibits funding not only for discrete acts that destroy

human embryos, but also for all “research in which” an embryo is “destroyed, discarded, or

knowingly subjected to risk of injury or death.” § 509(a)(2), 123 Stat. at 3280 (emphasis added).

Indeed, Dickey-Wicker’s structure confirms that Defendants’ purported distinction

between derivation of stem cells from embryos (in which the embryo is destroyed) and the

experimentation on the stem cells harvested from the destroyed embryos is their own creation,

not a feature of the statute. Congress structured the Dickey-Wicker Amendment such that it

contains two subsections: Subsection (1) prohibits the specific act of using federal funds for the

creation of a human embryo or embryos for research purposes, while subsection (2) broadly

prohibits all “research in which” a human embryo or embryos are destroyed, discarded, or

knowingly threatened. As this Court has explained, “[h]ad Congress intended to limit the

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Dickey-Wicker to only those discrete acts that result in the destruction of an embryo, like the

derivation of ESCs, or to research on the embryo itself, Congress could have written the statute

that way.” (Dkt. #44, at 11.)

Congress is presumed not to enact Rube Goldberg-style statutes. See, e.g., Ali v. Fed.

Bureau of Prisons, 552 U.S. 214, 227 (2008) (rejecting petitioner’s interpretation of a statute, in

part because “[h]ad Congress intended to limit [the statute’s] reach as petitioner contends, it

easily could have written [it that way]”). Dickey-Wicker is no exception: Congress’s choice to

prohibit broadly the funding of “research in which” embryos are destroyed plainly rejects the

distinction pressed by Defendants. See Russello v. United States, 464 U.S. 16, 23 (1983)

(“Where Congress includes particular language in one section of a statute but omits it in another

section of the same Act, it is generally presumed that Congress acts intentionally and purposely

in the disparate inclusion or exclusion.”).

(b) Defendants’ Counsel’s “Piece of Research” Interpretation Defies the Statutory Text, Conflicts with Defendants’ Interpretation Outside This Litigation, and Ignores the Context in Which Dickey-Wicker Was Enacted

In an effort to circumvent the structure and plain language of the statute, Defendants’

counsel has argued that “research” can mean “a piece of research,” and has therefore claimed

that Dickey-Wicker does not preclude Defendants from funding “piece[s]” of embryonic stem

cell research so long as the funding is not used for the actual destruction of human embryos—

even though the funded research necessarily requires such destruction. (Mem. in Support of

Defs.’ Mot. to Dismiss, and in Opp’n to Pls.’ Mot. for Prelim. Inj. at 31 [Dkt. #23].) This Court

has already rejected this argument (Dkt #44, at 11), and for good reason—Defendants’ proposed

interpretation does violence to the statutory text, conflicts with Defendants’ interpretation of

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“research” outside the context of this litigation, and ignores the circumstances surrounding

Dickey-Wicker’s enactment.

The statutory prohibition against funding any “research in which” embryos are destroyed

necessarily encompasses all of the research project at issue, not merely a selected “phase” or

“piece” of the research. Indeed, outside of this litigation, NIH and HHS have recognized that

“research” encompasses the entire research process, and cannot be narrowed to include only

individual tasks within a research project. For instance, in the Human Subject Protection

Regulations—incorporated by Congress in the Dickey-Wicker Amendment—NIH defined

“research” as “a systematic investigation, including research development, testing and

evaluation, designed to develop or contribute to generalizable knowledge.” (SOF ¶ 46; 45

C.F.R. § 46.102(d); see also § 509(a)(2)(b), 123 Stat. at 3281.) And HHS has stated that, under

these regulations, an institution that receives federal funding is generally engaged in human

subjects research “even where all activities involving human subjects are carried out by

employees or agents of another institution.” (SOF ¶ 47; Dep’t of Health & Human Servs.,

Guidance on Engagement of Institutions in Human Subjects Research (Oct. 16, 2008), available

at http://www.hhs.gov/ohrp/humansubjects/ guidance/engage08.html (emphasis added).) What

other view of “research” could HHS have had when it instructed that an institution that receives a

grant for non-exempt human subjects research is still engaged in research involving human

subjects even if it does not directly interact with human subjects?

Interpreting “research” to include only a portion of a research project is also inconsistent

with courts’ use of that term. For instance, in Merck KGaA v. Integra Lifesciences I, Ltd., 545

U.S. 193 (2005), the Supreme Court, in analyzing the scope of the research exemption under the

patent statute, acknowledged that “research” is a multi-phase process rather than a single

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experiment: “There is simply no room in the statute for excluding certain information from the

exemption on the basis of the phase of research in which it is developed or the particular

submission in which it could be included.” Id. at 202 (emphasis added); see also Nat’l Ctr. for

Mfg. Scis., Inc. v. City of Ann Arbor, 563 N.W.2d 65, 68 (Mich. Ct. App. 1997) (agreeing that

“research is not limited to a specific experiment” but includes “other critical steps in the research

process [such as] the definition of the research agenda, raising the money to perform the

necessary experiments, and the monitoring and evaluation of the results”). Thus, Defendants’

counsel’s “piece of research” argument is without merit.

Defendants’ “piece of research” argument is further belied by the fact that Congress

prohibited funding not only for research in which embryos are “destroyed,” but also research in

which embryos are “discarded.” § 509(a)(2), 123 Stat. at 3280. Plainly, therefore, Congress

understood that the term “research” as used in Dickey-Wicker extends broadly to include the act

of discarding an embryo as part of a research project, and Congress undoubtedly intended to ban

federal funding of any projects that entailed such action. Defendants’ interpretation, by contrast,

would render this prohibition meaningless, because the funding prohibition would apply only to

the mere act of discarding the embryo; the remainder of the research project could be funded, an

absurd result that Congress could not possibly have intended when it enacted Dickey-Wicker.

Indeed, the Guidelines themselves acknowledge that the act of destroying embryos is

integral to, and inextricable from, “research” involving embryonic stem cells, because the

Guidelines regulate the process by which embryos are selected and ultimately destroyed for

purposes of federally-funded research. See Fed. Reg. 32,170 (noting that “the Guidelines pertain

primarily to the donation of embryos for the derivation of [human embryonic stem cells]”). The

Guidelines require that NIH-funded researchers delve into the matter of derivation to ensure that

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the process by which the embryos were selected for destruction was in accordance with the

Guidelines. See 74 Fed. Reg. at 32,174 § II(A) (providing that applicant institutions “proposing

research” using human embryonic stem cells may either use human embryonic stem cell lines

posted on the NIH registry or “establish eligibility” for funding by “submitting an assurance of

compliance” with § II(A) of the Guidelines and setting forth the criteria for how “[human

embryonic stem cells] should have been derived from human embryos”). Defendants cannot

plausibly contend that the embryonic stem cell research that they propose to fund is wholly

separate and distinct from the destruction of human embryos while at the same time regulating

the process by which embryos are destroyed, and requiring that NIH-funded researchers

investigate the same.

Defendants’ interpretation also defies common sense. The Guidelines permit the same

researcher both to derive stem cells from an embryo and to receive federal funding for all

research activities involving those cells. 74 Fed. Reg. at 32,173 (“[it] is not always possible, nor

is it required” that the in vitro fertilization “doctor and the researcher seeking donation . . . be

different individuals”); id. at 32,174 (“[t]he attending physician responsible for reproductive

clinical care and the researcher deriving and/or proposing to utilize [human embryonic stem

cells] should not have been the same person unless separation was not practicable” (emphasis

added)); SOF ¶ 42. To suggest that a federal grant recipient is not engaged in “research in

which” a human embryo is destroyed when the researcher conducts a study that entails derivation

of the stem cells—and hence destruction of an embryo—as the essential initial step of the

research effort barely passes the straight-face test. See Harbor Gateway Commercial Prop.

Owners Ass’n v. EPA, 167 F.3d 602, 606 (D.C. Cir. 1999) (rejecting the EPA’s interpretation of

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an appropriations rider because “there [was] no reason to mistrust the common sense

understanding of the statutory language” (internal quotation omitted)).

(c) The Guidelines Violate Dickey-Wicker Because They Knowingly Subject Human Embryos to Risk of Death or Injury by Incentivizing the Destruction of Additional Embryos

Even assuming that the word “research” could be limited to a specific “piece” of that

research, the Guidelines would still violate Dickey-Wicker. Defendants’ interpretation also

ignores the statutory prohibition against funding “research in which” embryos are “knowingly

subjected to risk of injury or death.” § 509(a)(2), 123 Stat. at 3280. It cannot be denied that the

Guidelines, and the federally funded research that they contemplate, have created a need for

additional, newly derived human embryonic stem cells, and thus for the destruction of additional

human embryos. As a consequence, it is incontrovertible that by funding embryonic stem cell

research, Defendants (and the researchers they fund) are knowingly subjecting additional

embryos to risk of death.

A person does not need to intend a consequence in order to act “knowingly”—he need

only set in motion a chain of events that ultimately leads to a foreseeable result. See, e.g., H.A.L.

v. Foltz, 551 F.3d 1227, 1230 (11th Cir. 2008) (holding that a state employee “knowingly

subjected [foster children] to a substantial risk of victimization” by placing another child with a

history of aggressive sexual behavior in the same home (emphasis added)). Under NIH’s

Guidelines, grant-awarding officials and federally funded researchers will “knowingly subject”

human embryos “to risk of injury or death” by funding and conducting embryonic stem cell

research that inevitably creates a substantial risk—indeed, a virtual certainty—that more human

embryos will be destroyed in order to derive more embryonic stem cells for research purposes.

Whenever a privately funded researcher destroys an embryo in order to satisfy a request for

embryonic stem cells from a federally funded scientist—a practice allowed under NIH’s

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Guidelines—the public scientist knows that his request, which is an integral part of his research,

will subject living human embryos “to risk of injury or death.” Similarly, by awarding new

grants for such research, NIH officials inevitably create demand for additional, newly derived

stem cells. Thus, there can be no question that NIH officials are knowingly subjecting human

embryos to risk of death. Indeed, the Guidelines—by regulating the process by which those

embryos are selected for destruction—explicitly contemplate the destruction of additional

embryos for purposes of federally funded research. See 74 Fed. Reg. at 32,174. The Guidelines

therefore violate the Dickey-Wicker Amendment even under NIH’s interpretation of the

statutory language.

(d) Dickey-Wicker’s Ambiguous Legislative History Cannot Eclipse the Unambiguous Statutory Text

Unable to reconcile the Guidelines with Dickey-Wicker’s plain language, Defendants

have previously relied on bits of legislative history in an effort to shift focus away from the

statutory text. But reference to legislative history is inappropriate when—as here—the text of a

statute is unambiguous. Dep’t of Hous. & Urban Dev. v. Rucker, 535 U.S. 125, 132 (2002); see

also United States ex rel. Totten v. Bombardier Corp., 380 F.3d 488, 494 (D.C. Cir. 2004)

(Roberts, J.) (stating that “‘[l]egislative history is irrelevant to the interpretation of an

unambiguous statute’” (quoting Davis v. Mich. Dep’t of Treasury, 489 U.S. 803, 808–09 n.3

(1989))).

There are, to be sure, statements in the legislative history supporting Defendants’

interpretation. See, e.g., Statement of Sen. Specter, 145 Cong. Rec. S11585-07, *S11586 (Sept.

29, 1999). But numerous statements support Plaintiffs’ interpretation as well. For example, the

Amendment’s co-author, Congressman Jay Dickey, has explained that federal funding of

embryonic stem cell experiments that incentivizes the destruction of human embryos

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“undermines the spirit and letter of the law.” Special Hearing on Stem Cell Research: Hearing

before the Subcommittee on Labor, Health, and Education of the S. Comm. on Appropriations,

106 Cong. 9–10 (Nov. 4, 1999).6 Legislative history is therefore unhelpful because it “supports

conflicting inferences and provides scant illumination.” Carter v. United States, 530 U.S. 255,

271 n.9 (2000); see also Lamie v. U.S. Trustee, 540 U.S. 526, 539–42 (2004) (resting holding on

the statutory text because the statute’s legislative history “create[d] more confusion than clarity

about the congressional intent”). This only “further confirms the wisdom of relying on the

legislative text to determine the purpose of [the statute].” Nat’l Ass’n of Mfrs. v. Taylor, 582

F.3d 1, 13 (D.C. Cir. 2009) (emphasis added).

In any event, as Justice Scalia has explained, statements in House committee reports “tell

us nothing about what [a] statute means, since (1) we do not know that the members of the

Committee read the Report, (2) it is almost certain that they did not vote on the Report . . . , and

(3) even if they did read and vote on it, they were not, after all, those who made th[e] law. The

statute . . . is a law because its text was approved by a majority vote of [Congress], and was

signed by the President.” Milavetz, Gallop & Milavetz v. United States, 130 S. Ct. 1324, 1341–

42 (2010) (Scalia., J., concurring in part). Defendants cannot evade the unambiguous meaning

6 See also, e.g., Statement of Rep. Schaffer, 145 Cong. Rec. E1696-02, 1696-97 (July 30, 1999) (“While HHS has tried to rewrite the current law on embryo research, it is clear that Congress has prohibited all funding of ‘research in which’ embryos are destroyed or discarded. Simply stated, the taxpayer funding of research which relies on the intentional killing of human beings would violate the law.”); Statement of Sen. Brownback, 147 Cong. Rec. S6393-01, 6394 (July 19, 2004) (expressing same view); id. (placing in the record a letter from twenty Senators to NIH urging the agency to withdraw the “Clinton-era guidelines which call for the destruction of human embryos for the purpose of subsequent Federal funding for the cells that have been derived from the process of embryo destruction” because they were “contrary to the law and Congressional intent,” and stating that “[c]learly, the destruction of human embryos is an integral part of the contemplated research, in violation of the law”).

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of the statute based on snippets or inferences drawn from legislative history. “If Congress

wished to achieve that result, it needed to enact different statutory language. It c[an]not achieve

that result, in the face of the statutory language it enacted, simply by inserting a passage in a

committee report.” Penn. Protection & Advocacy, Inc. v. Houston, 228 F.3d 423, 427–28 (3d

Cir. 2000) (Alito, J.).

2. No Deference Is Due Defendants’ Interpretation of Dickey-Wicker’s Unambiguous Terms

Defendants also have claimed previously that their interpretation of Dickey-Wicker is

entitled to deference under Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467

U.S. 837, 842 (1984). (Mem. in Support of Defs.’ Mot. to Dismiss, and in Opp’n to Pls.’ Mot.

for Prelim. Inj. at 30 [Dkt. #23].) As this Court has already stated, no such deference is due.

First, the statute plainly prohibits the funding of “research in which” embryos are

destroyed or knowingly threatened. Because “Congress has directly spoken to the precise

question at issue,” “that is the end of the matter,” and no deference is due to Defendants’

contrary interpretation. Chevron, 467 U.S. at 842–43; see also Gen. Dynamics Land Sys., Inc. v.

Cline, 540 U.S. 581, 600 (2004) (“Even for an agency able to claim all the authority possible

under Chevron, deference to its statutory interpretation is called for only when the devices of

judicial construction have been tried and found to yield no clear sense of congressional intent.”

(emphasis added)); Dkt. #44, at 10 (“Congress has spoken to the precise question here—whether

federal funds may be used for research in which an embryo is destroyed.”).

Second, even if there were some ambiguity in the statute (which there is not), Defendants

would plainly deserve no such deference here, because neither NIH nor HHS has ever proffered

an authoritative interpretation of “research” that this Court could analyze for reasonableness

under Chevron. (See SOF ¶ 49.) To receive deference, an agency must in fact interpret the

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statutory provision in question, Pub. Citizen, Inc. v. Dep’t of Health & Human Servs., 332 F.3d

654, 661 (D.C. Cir. 2003), and must do so in a rule “carrying the force of law,” United States v.

Mead Corp., 533 U.S. 218, 226–27 (2001). But instead of setting forth an interpretation of

“research,” the Defendants contend in the Guidelines that their funding of embryonic stem cell

research does not violate Dickey-Wicker because “[human embryonic stem cells] are not

embryos as defined by Section 509.” 74 Fed. Reg. at 32,173. The relevant question is not

whether embryonic stem cells are embryos, however, but whether the derivation of those cells

occurs as part of “research” that receives funding. Because the agencies have never answered

that question in a rule carrying the force of law (see SOF ¶ 49), there is no interpretation to

which this Court can defer. Chevron deference does not operate in a vacuum. See, e.g., Pub.

Citizen, 332 F.3d at 661 (holding that Chevron was “inapplicable”—even though the agency’s

guidance “does contain a reference” to the statute at issue—because “there is no place in the

manual where the agency explains why it believes that [its conclusion] satisfies the statut[e]” ).7

7 Although an agency need not define every word in a statute to receive Chevron deference, there must be evidence that the agency in fact considered the critical statutory terms in proffering its interpretation; Chevron does not authorize courts to guess at what an agency had in mind. See Nat’l R.R. Passenger Corp. v. Boston & Maine Corp., 503 U.S. 407, 420 (1992) (deferring to the ICC’s interpretation of the word “required” because it “was a necessary presupposition of the ICC’s decision” and “the only reasonable reading of the Commission’s opinion,” and noting that “neither party contend[ed] that the ICC’s decision was not informed and governed by th[e] statutory interpretation”). Here, Defendants have given no indication that they ever considered whether the derivation of embryonic stem cells occurs as part of federally funded “research” that destroys or knowingly subjects human embryos to the risk of injury or death, or whether Defendants’ funding of embryonic stem cell research “knowingly subject[s]” embryos to risk of harm. Cf. Pub. Citizen, 332 F.3d at 661 (holding that Chevron was “inapplicable”—even though the agency’s guidance “does contain a reference” to the statute at issue—because “there is no place in the manual where the agency explains why it believes that [its conclusion] satisfies the statut[e]”).

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It is only in this litigation that Defendants’ counsel for the first time have attempted to

articulate why embryonic stem cell research that depends on the further destruction of human

embryos is consistent with Dickey-Wicker—because, according to counsel, “research” can mean

a “piece of research.” But that interpretation has never been offered in any official agency

statement promulgated through notice-and-comment procedures (see SOF ¶ 49(a)), and the law

is clear that agencies are not entitled to deference for interpretations offered by their counsel in

legal briefs. See Bowen v. Georgetown Univ. Hosp., 488 U.S. 204, 212 (1988) (“[W]e have

declined to give deference to an agency counsel’s interpretation of a statute where the agency

itself has articulated no position on the question, on the ground that Congress has delegated to

the administrative official and not to appellate counsel the responsibility for elaborating and

enforcing statutory commands.” (internal quotation omitted)); City of Kansas City v. Dep’t of

Hous. & Urban Dev., 923 F.2d 188, 192 (D.C. Cir. 1991) (refusing to award Chevron deference

to a “post hoc rationale developed as part of a litigation strategy”); Pub. Citizen, 332 F.3d at 661.

Finally, even if post-hoc explanations in legal briefs could receive deference, Defendants’

counsel’s “interpretation” would not merit any here because it is not based on an exercise of the

agencies’ expertise, but rather on a definition cribbed from a dictionary. (Defs’ Mot. to Dismiss

at 31 [Dkt. #23].) An agency cannot “rest simply on its parsing of the statutory language—it

must bring its experience and expertise to bear in light of competing interests at stake.” Peter

Pan Bus Lines, Inc. v. Fed. Motor Carrier Safety Admin., 471 F.3d 1350, 1354 (D.C. Cir. 2006)

(internal quotation and alteration omitted); see also Crowley v. Fed. Bureau of Prisons, 312 F.

Supp. 2d 453, 459 (S.D.N.Y. 2004) (“Mead and Chevron explain . . . a key rationale behind

affording deference to agencies is that their interpretations are properly informed by their

experience and their expertise.”).

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Defendants have utilized no such experience or expertise here. The only explanation

Defendants have offered for their counsel’s interpretation of “research” is their counsel’s

dictionary definition of that term—that “research” can mean a “piece of research.” Putting aside

the tautological nature of that definition—under which “research” means “research”—

Defendants’ counsel’s simple parsing of the statute is not the kind of application of agency

expertise that merits judicial deference. See Alarm Indus. Commc’ns Comm. v. F.C.C., 131 F.3d

1066, 1069 (D.C. Cir. 1997) (holding that an agency is afforded no deference when it attempts to

give “its meaning to the provision on the basis of a dictionary”). Any party can consult a

dictionary; an agency must bring its particular expertise to bear. Because Defendants have not

done so here, they are not due any deference (Chevron, Skidmore, or otherwise).8

IV. Defendants Promulgated the Guidelines in Violation of the Administrative Procedure Act

In response to the Draft Guidelines, Defendants received almost 50,000 public comments

on various aspects of the proposed decision to fund embryonic stem cell research and the manner

in which to fund such research. (See SOF ¶ 37; Nat’l Institutes of Health, Listing of Comments

on Draft NIH Human Stem Cell Guidelines, http://grants.nih.gov/stem_cells/web_listing.htm?

(last visited Aug. 16, 2010).) It is incontrovertible that Defendants were required to consider and

respond to these comments and to “examine the relevant data and articulate a satisfactory

explanation for [their] action including a ‘rational connection between the facts found and the

8 In Mead, the Supreme Court noted that even where an agency’s interpretation is not entitled to Chevron deference, that interpretation may still be entitled to some “respect proportional to its ‘power to persuade’” where the agency “bring[s] the benefit of specialized experience to bear on the subtle questions in th[e] case.” Mead, 533 U.S. at 235 (quoting Skidmore v. Swift & Co., 323 U.S. 134, 140 (1944)). Because NIH has not brought its “specialized experience to bear,” however, its interpretation is not entitled even to Skidmore deference.

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choice made.’” Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto Ins. Co., 463 U.S. 29, 43

(1983) (quoting Burlington Truck Lines v. United States, 371 U.S. 156, 158 (1962)).

Defendants plainly did not satisfy these requirements in promulgating the Guidelines.

The President ordered Defendants to fund only stem cell research that is “responsible” and

“scientifically worthy,” 74 Fed. Reg. 10,667 (attached as Aden Decl., Ex. A), and Defendants

received numerous public comments explaining why human embryonic stem cell research is

neither ethically responsible nor scientifically worthy. (SOF ¶¶ 28(x)–(hh), 32(d)–(g), 32(m);

see, e.g., Aden Decl., Ex. D; see also Aden Decl., Ex. F at 1–2.) Those comments explained that

scientifically valid alternatives to embryonic stem cell research exist that present far greater

promise for success and that do not raise the same serious ethical problems. (See, e.g., Aden

Decl., Ex. D at 9–10, 18, G-4 to G-8, H-1 to H-4.) But Defendants ignored the comments in the

administrative record and failed to articulate any reasoned basis for funding embryonic stem cell

research instead of these scientifically and ethically superior alternatives. In doing so,

Defendants acted arbitrarily and capriciously and failed to follow procedures prescribed by law.

Summary judgment should therefore be entered in favor of the Plaintiffs.

A. Defendants’ Promulgation of the Guidelines Was Arbitrary and Capricious and Violated Procedures Required by Law

An agency acts arbitrarily and capriciously and violates procedures required by the APA

when it fails to respond to relevant and “significant” public comments. See Am. Mining Cong. v.

EPA, 907 F.2d 1179, 1190–91 (D.C. Cir. 1990). Defendants completely ignored every public

comment categorically objecting to funding of embryonic stem cell research, despite the fact that

those comments plainly were relevant to the proposed rulemaking and raised significant

questions about the ethical and scientific problems with such research. See infra note 9. If

Defendants had considered the comments, they would have been exposed to a wealth of

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literature and information demonstrating that non-embryonic stem cell research programs are

ethically and scientifically superior to embryonic stem cell research as a categorical matter.

Because Defendants failed to examine the relevant data and articulate a satisfactory explanation

for the decision to fund embryonic stem cell research, they acted arbitrarily and capriciously

within the meaning of 5 U.S.C. § 706(2)(A), and violated procedures required by law.

Accordingly, the Guidelines must be set aside.

NIH’s stated purpose in promulgating the Guidelines was to ensure that NIH funding is

“ethically responsible, scientifically worthy, and conducted in accordance with applicable law,”

74 Fed. Reg. at 32,170, which echoes the President’s salutary goal of ensuring that “scientific

data is never distorted or concealed to serve a political agenda—and that we make scientific

decisions based on facts, not ideology,” President Barack Obama, Signing of Stem Cell

Executive Order and Scientific Integrity Presidential Memorandum (Mar. 9, 2009), available at

http://www.whitehouse.gov/the_press_office/Remarks-of-the-President-As-Prepared-for-

Delivery-Signing-of-Stem-Cell-Executive-Order-and-Scientific-Integrity-Presidential-

Memorandum (attached as Aden Decl., Ex. O). Yet Defendants allowed ideology, not facts, to

drive their decision to fund research that is ethically objectionable and scientifically dubious.

During the public comment period, Defendants received numerous comments detailing

the many scientific problems with human embryonic stem cell research. (E.g., SOF ¶ 28(y)–(ff);

Aden Decl., Ex. D at 11–13, G-1, G-8, I-1 to I-11.) For example, embryonic stem cells form

tumors (SOF ¶ 28(aa)–(cc); Aden Decl., Ex. D at I-2 to I-3), and they do not differentiate into the

type of cells needed for therapeutic treatments (SOF ¶ 28(y); Aden Decl., Ex. D at I-1). As a

result, they are biologically inadequate replacements for lost adult cells. (SOF ¶ 28(ff); Aden

Decl., Ex. D at I-1.)

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As the comments in the record before the agency demonstrate, these serious problems

simply do not plague the use of adult stem cells, which “provide or promise to provide actual

cell-based therapies that will lead to beneficial results for patients . . . .” (SOF ¶ 28(b); Aden

Decl., Ex. D at 2.) Importantly, adult stem cells do not cause tumors when used in treatment.

(SOF ¶ 28(k); Aden Decl., Ex. D at G-8.) Accordingly, adult stem cell research is an ethically

superior alternative and “worthy scientific priority meriting federal funding . . . .” (SOF ¶ 32(n);

Aden Decl., Ex. D at 9.)

The NIH also received comments regarding recent breakthroughs with respect to induced

pluripotent stem cell lines that obviate any alleged need for ethically problematic research using

human embryonic stem cells. The comments explained that induced pluripotent stem cells are

produced by genetically reprogramming mature cells yet are essentially indistinguishable from

embryonic stem cells for research purposes, and so they offer all the purported benefits of

embryonic stem cell research (and more) without creating the same ethical problems. (SOF

¶ 28(m)–(p), (v)–(w); Aden Decl., Ex. D at 10–11; see also SOF ¶ 63.)

Notwithstanding the extensive comments in the administrative record demonstrating

these glaring weaknesses of embryonic stem cell research and the categorical superiority of adult

stem cell research and induced pluripotent stem cell research, NIH failed to offer any explanation

for its decision to devote limited federal research funds to embryonic stem cell research. The

agency thus failed to justify its decision in light of its own stated criterion that the Guidelines

would fund only “scientifically worthy” research.

The comments also establish the myriad ethical problems posed by human embryonic

stem cell research. Such research necessarily involves the killing of the human embryo from

which the embryonic stem cells are harvested. (See SOF ¶¶ 45(c), 50; Aden Decl., Ex. D at 5.)

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For this reason, as the National Bioethics Advisory Commission—created by President Clinton

and whose members the President appointed (see Executive Order 12,975, 60 Fed. Reg. 52,063

(Oct. 5, 1995)—explained, “derivation of stem cells from embryos remaining following

infertility treatments is justifiable only if no less morally problematic alternatives are available

for advancing the research.” Nat’l Bioethics Advisory Comm’n, 1 Ethical Issues in Human Stem

Cell Research 53 (Sept. 1999) (attached as Aden Decl., Ex. P). Adult and induced pluripotent

stem cell research, by contrast, do not require this destruction of human embryos, and are

therefore ethically superior forms of research. (See SOF ¶¶ 28(d), 28(m), 28(o), 28(w), 32(n);

see, e.g., Aden Decl., Ex. D at 9–10, H-3.)

Under the APA, NIH was required to “respond in a reasoned manner to the comments

received, to explain how the agency resolved any significant problems raised by the comments,

and to show how that resolution led the agency to the ultimate rule.” Action on Smoking &

Health v. Civil Aeronautics Bd., 699 F.2d 1209, 1216 (D.C. Cir. 1983) (internal quotation marks

omitted). Despite that requirement, Defendants ignored all comments objecting categorically to

embryonic stem cell research.9 Defendants thus failed to “examine the relevant data and

[Footnote continued on next page]

9 Defendants received “approximately 49,000 comments” on the Guidelines, 74 Fed. Reg. at 32,170; see SOF ¶ 37, including “[a]bout 30,000” comments “debat[ing] whether the NIH should be funding embryonic stem cell research” at all (Aden Decl., Ex. F (emphasis added); SOF ¶ 38). But Defendants admitted that they “disregarded all such comments” (60 percent of the total comments), instead branding such comments “unresponsive,” because, as NIH’s then-Director explained, “[NIH] actually did not ask the public whether we should fund research on human embryonic stem cells. [NIH] asked the public how we should fund human embryonic stem cell research.” (SOF ¶¶ 38 & 38(a); Aden Decl., Ex. F (emphases added and internal quotation marks omitted).) Indeed, Defendants argued before this Court that NIH “properly ignored . . . the relative merits” of human embryonic stem cell research (Defs.’ Memo. in Support of Mot. to Dismiss at 44 [Dkt. #23]; SOF ¶ 39), and that “NIH responded appropriately to comments that were relevant to the formulation of the Guidelines, namely, comments that addressed the

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articulate a satisfactory explanation for its action, including a rational connection between the

facts and the choice made,” U.S. Telecom Ass’n v. FCC, 227 F.3d 450, 461 (D.C. Cir. 2000)

(internal quotation marks omitted), with respect to their decision to use limited funding for

embryonic stem cell research.

In fact, although the record before the agency establishes as a categorical matter that

adult and induced pluripotent stem cell research are scientifically and ethically superior

alternatives, Defendants did not even acknowledge—much less explain away—the important

scientific and ethical problems with embryonic stem cell research. Because Defendants have not

proffered any valid reason for failing to “respond[] to significant points raised by the public,”

Home Box Office, Inc. v. FCC, 567 F.2d 9, 35–36 (D.C. Cir. 1977), the Guidelines were

promulgated arbitrarily and capriciously and “without observance of procedure required by law,”

5 U.S.C. § 706(2)(D); Am. Mining Cong., 907 F.2d at 1190–91 (“[T]he agency’s failure to

respond to . . . specific challenges in the record is fatal here, since ‘the points raised in the

comments were sufficiently central that agency silence . . . demonstrate[s] the rulemaking to be

arbitrary and capricious.’”); see also Arkansas v. Oklahoma, 503 U.S. 91, 113 (1992) (citing

State Farm, 463 U.S. at 43). Indeed, NIH’s disregard of its own stated criteria—namely, its

goals of funding only “scientifically worthy” and “ethically responsible” research—is the

essence of arbitrary and capricious decision-making. See, e.g., Am. Equity Inv. Life Ins. Co. v.

SEC, 572 F.3d 923, 934 (D.C. Cir. 2009) (an agency “must defend its analysis before the court

upon the basis it employed in adopting that analysis”—even if “the [agency] was not required”

by statute to base its decision on those grounds (citing SEC v. Chenery Corp., 318 U.S. 80, 87 [Footnote continued from previous page]

substance of the informed consent procedures that NIH proposed to establish” (Defs.’ Reply in Support of Mot. to Dismiss at 20 [Dkt. #32]; SOF ¶ 39).

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(1943))); Int’l Ladies’ Garment Workers’ Union v. Donovan, 722 F.2d 795, 815 (D.C. Cir.

1983).

Any post-hoc justification Defendants might now offer is plainly insufficient under the

APA. See, e.g., Bowen, 488 U.S. at 212; Chenery Corp., 318 U.S. at 87 (“The grounds upon

which an administrative order must be judged are those upon which the record discloses that its

action was based.”); Fort Stewart Schs. v. Fed. Labor Relations Auth., 495 U.S. 641, 651–52

(1990) (“[I]t is elementary that if an agency’s decision is to be sustained in the courts on any

rationale under which the agency’s factual or legal determinations are entitled to deference, it

must be upheld on the rationale set forth by the agency itself.”). Even if there were good

scientific and ethical reasons to authorize funding of embryonic stem cell research (and there are

not), Defendants were required to explain such reasons in response to the numerous comments in

the administrative record that establish the categorically unethical and scientifically unworthy

nature of human embryonic stem cell research. Because Defendants offered no such explanation

or justification, the Guidelines must be set aside.

B. Defendants Entered the Comment Period with an Unalterably Closed Mind

The Guidelines are invalid for the additional reason that Defendants, by their own

admission, entered the rulemaking period having already made the decision to fund embryonic

stem cell research. Agencies cannot fulfill their duty to consider important comments, see 5

U.S.C. § 553(c), when the key agency decision maker “has an unalterably closed mind on

matters critical to the disposition of the proceeding.” Ass’n of Nat’l Advertisers, Inc. v. FTC, 627

F.2d 1151, 1170 (D.C. Cir. 1979). Defendants in this case have admitted their minds were

closed with respect to the question whether to fund embryonic stem cell research, and the

Guidelines should therefore be invalidated.

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Even before the comment period began, Acting NIH Director Raynard Kington10

announced the predetermined result of the rulemaking. On April 17, 2009, Kington reported to

the press that NIH “will expand greatly the number of cell lines eligible for funding.” (SOF ¶ 25;

Aden Decl., Ex. I [Gautam Naik, NIH Offers Rules for Embryonic Stem Cell Research, Wall St.

J., Apr. 17, 2009] (emphasis added)). And, as noted, Kington admitted after the Guidelines had

been promulgated that he and the agency had ignored all public comments that addressed the

question whether to fund embryonic stem cell research. (See SOF ¶ 38; Aden Decl., Ex. F at 1–

2.) Kington claimed that NIH “did not ask the public” for input on that question. (SOF ¶ 38(a);

Aden Decl., Ex. F at 2.)

This closed-minded approach plainly violated Defendants’ duty under the APA. See 5

U.S.C. § 553(c). In Nehemiah Corp. of America v. Jackson, 546 F. Supp. 2d 830, 847–48 (E.D.

Cal. 2008), the court determined that Housing and Urban Development Secretary Jackson had

entered a rulemaking proceeding with an “unalterably closed mind” about the merits of a

proposed rule. During the comment period, a Bloomberg News report quoted Secretary Jackson

as stating his views on the proposed rule and claiming that the agency “intend[ed] to approve the

new rule by the end of the year even if the agency receive[d] critical comments.” Id. at 847.

Based on these statements, the court ordered that Secretary Jackson be excluded from the

decision-making process on remand to the agency. Id. at 849.

Kington’s actions in this case are far more egregious than those in Nehemiah. Indeed,

Defendants have never disputed that they entered the rulemaking process already set on funding

embryonic stem cell research—the only open question was how they would achieve that pre-

10 Kington served as the Acting Director of NIH from October 31, 2008 to August 7, 2009, when the Senate confirmed Dr. Francis Collins as the new Director of NIH.

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determined goal. (See SOF ¶ 38(a); Aden Decl., Ex. F (“[NIH] actually did not ask the public

whether we should fund research on human embryonic stem cells. We asked the public how we

should fund human embryonic stem cell research.” (emphasis added)). This plainly violated the

APA, and the Guidelines must therefore be set aside.

C. The Executive Order Did Not and Could Not Exempt Defendants from the Requirements of the APA

Defendants have not even suggested that they considered the comments they received

that explain why human embryonic stem cell research is, as a categorical matter, neither ethically

responsible nor scientifically worthy. Instead, Defendants have claimed, both before this Court

and on appeal, that President Obama’s order did not leave them discretion to consider whether to

fund embryonic stem cell research. (See Defs.’ Memo. in Support of Mot. to Dismiss at 43 [Dkt.

#23]; Defs.’ Br. on Appeal at 15, 29–30.) But Defendants are incorrect, both factually and

legally. The President’s Executive Order did not remove Defendants’ discretion to decide

whether to fund embryonic stem cell research; and even if it had purported to do so, the President

could not free Defendants of their obligations under the APA.

1. The President Did Not Direct Defendants to Fund Embryonic Stem Cell Research and Therefore Defendants Violated the APA by Failing to Explain Why They Rejected Comments with Categorical Objections to Such Funding

The Executive Order contained no directive to fund human embryonic stem cell research.

The Order speaks in explicitly non-mandatory terms, stating that NIH “may” support

“responsible, scientifically worthy” stem cell research (SOF ¶ 20; 74 Fed Reg. 10,667 § 2

(attached as Aden Decl., Ex. A)); it did not state NIH shall support all forms of such research.

See United States v. Rodgers, 461 U.S. 677, 706 (1983) (the term “may” is usually

discretionary). Moreover, the Order directs Defendants to issue guidance on “human stem cell

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research,” not specifically on human embryonic stem cell research. (SOF ¶ 20; 74 Fed. Reg.

10,667 § 3.)

In short, the Order states that Defendants may support “responsible, scientifically worthy

human stem cell research, including human embryonic stem cell research.” (SOF ¶ 20; 74 Fed.

Reg. 10,667 § 2.) NIH was therefore free, within the framework of the APA and in light of the

comments received, to determine whether embryonic stem cell research is “responsible” and

“scientifically worthy,” but the Order did not purport to absolve Defendants of the task of

determining whether embryonic stem cell research satisfies these criteria. It was incumbent on

Defendants to determine whether embryonic stem cell research ever meets the criteria required

by the President, and to bring their “experience and expertise to bear in light of competing

interests at stake.” Peter Pan Bus Lines, Inc., 471 F.3d at 1354. They plainly failed to do so.

To comply with the requirements of the APA, the Defendants needed to confront

whether, as a categorical matter, embryonic stem cell research was both scientifically worthy

and ethically responsible. There were numerous public comments arguing that embryonic stem

cell research is not scientifically worthy or ethically responsible as a categorical matter. (See,

e.g., SOF ¶¶ 28(hh), 32(m); Aden Decl., Ex. D at 11, 18, J-3 to J-5.) By determining, in the

Guidelines, that such research is at least sometimes scientifically worthy and ethically

responsible, Defendants rejected these comments.

Defendants have argued previously that the Guidelines simply postponed all categorical

decisions on research until the application stage, but that is simply not true. As promulgated, the

Guidelines contain several categorical limitations. For example, the Guidelines categorically

prohibit the use of any funds for cloning or breeding of animals (SOF ¶ 43; 74 Fed. Reg. at

32,175, §§ IV, V), presumably for ethical reasons. And they mandate that “[n]o payments, cash

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or in kind [may be] offered for the donated embryos” (SOF ¶ 44; 74 Fed. Reg. at 32,175,

§ II.A.3.b), also for ethical reasons, it would appear. Thus, Defendants adopted those categorical

limitations with which they agreed. By the same token, they necessarily rejected those

comments arguing that human embryonic stem cell research is, as a categorical matter,

scientifically unworthy and ethically irresponsible—yet they have offered no explanation for

doing so. This is a plain violation of the APA.

Finally, the President’s Order states that Defendants may fund stem cell research only “to

the extent permitted by law,” and the Order makes crystal clear that it “shall be implemented

consistent with applicable law.” (SOF ¶ 20; 74 Fed Reg. 10,667 §§ 2, 4 (emphases added).) The

Order therefore explicitly requires that Defendants follow all applicable law—including the

APA—when deciding whether to make such research eligible for funding. See Natural Res. Def.

Council, Inc. v. EPA, 683 F.2d 752, 765 (3d Cir. 1982) (“[Executive Order] 12291 says nothing

about the notice and comment requirements of the APA, and does not attempt to authorize an

agency to act without complying with those requirements. Rather, [Executive Order] 12291

specifically states that any action taken pursuant to it must be in compliance with applicable

law.”). Defendants thus had no purported Presidential mandate to ignore the APA.

2. The President Cannot Authorize Agencies to Disregard the Requirements of the APA

Even if the President had directed Defendants to fund embryonic stem cell research

without regard to the merits of such research, without engaging in reasoned decision-making,

and without responding to significant public comments, such a directive would not insulate the

Guidelines from review under the APA. To the contrary, the fact that the Guidelines “are based

on the President’s Executive Order hardly seems to insulate them from judicial review under the

APA, even if the validity of the Order were thereby drawn into question.” Chamber of

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Commerce of the U.S. v. Reich, 74 F.3d 1322, 1327 (1996), modified on other grounds, 83 F.3d

439 (D.C. Cir. 1996).

It is undisputed that the notice-and-comment rulemaking requirements of 5 U.S.C.

§ 553(c) govern Defendants’ decision to issue the Guidelines here. Nothing in the APA

authorizes the President to direct an agency to violate the APA by ignoring relevant public

comments during the rulemaking process, or in any way exempts an agency’s actions from APA

review even if the policy was dictated by the President. See Reich, 74 F.3d at 1328 (“Even if [an

agency] were acting at the behest of the President, this ‘does not leave the courts without power

to review the legality [of the action], for courts have power to compel subordinate executive

officials to disobey illegal Presidential commands.’” (quoting Soucie v. David, 448 F.2d 1067,

1072 n.12 (D.C. Cir. 1971))). Accordingly, even if the President had ordered Defendants to fund

embryonic stem cell research without regard to whether such research is ethically and

scientifically unworthy of funding (which he clearly did not), Defendants would still be bound

by the procedural requirements of the APA, including the requirement that they articulate a

reason for rejecting the numerous comments establishing that such funding is inappropriate

under Defendants’ own criteria.

There are no disputed facts that are material to resolution of this issue—it is undisputed

that Defendants received the comments and that they failed to respond. Defendants’ only

purported explanation for failing to respond is that they thought the President directed them to

fund embryonic stem cell research. But as set forth above, that excuse is neither correct nor a

sufficient justification for Defendants’ actions, and summary judgment in favor of Plaintiffs is

therefore required.

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V. Permanent Injunctive Relief Is Necessary and Appropriate

Because the NIH Guidelines violate federal law, Plaintiffs respectfully request that this

Court issue a permanent injunction to restrain Defendants’ ongoing legal violations and halt the

serious harm now being suffered by Plaintiffs. In granting Plaintiffs’ motion for a preliminary

injunction, this Court has already thoroughly addressed the requirements for granting such

equitable relief. Sherley v. Sebelius, No. 1:09-cv-1575 (RCL), 2010 U.S. Dist. LEXIS 86441, at

*20–23 (D.D.C. Aug. 23, 2010). In the short period of time since this Court issued its

preliminary injunction, nothing has changed that would require a different result. Further, just

two days ago, this Court denied Defendants’ motion to stay the preliminary injunction. (Order of

Sept. 7, 2010 [Dkt. #53].) In issuing a preliminary injunction, the Court found that “a stay would

flout the will of Congress, as this Court understands what Congress has enacted in the Dickey-

Wicker Amendment.” Id. at *1. Plaintiffs’ present submission shows definitively that the NIH

Guidelines violate both the Dickey-Wicker Amendment, as this Court has already indicated, and

the Administrative Procedure Act. There is no genuine question of fact as to the illegality of the

NIH Guidelines. As a result, upon declaring the Guidelines invalid, this Court should also grant

permanent injunctive relief.

When deciding whether to issue a permanent injunction, a district court must consider the

following factors: (1) success on the merits; (2) whether the plaintiff will suffer irreparable injury

absent an injunction; (3) the balance of the hardships (including harm to defendant and other

interested parties); and (4) the public interest. ACLU v. Mineta, 319 F. Supp. 2d 69, 87 (D.D.C.

2004) (“In determining whether to enter a permanent injunction, the Court considers a modified

iteration of the factors it utilizes in assessing preliminary injunctions: [listing factors above].”);

see Nat’l Ass’n of Psychiatric Health Sys. v. Shalala, 120 F. Supp. 2d 33, 44 (D.D.C. 2002). The

court should apply essentially the same standard when granting permanent injunctive relief as

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when granting preliminary injunctive relief, except that a plaintiff must show actual success on

the merits, as opposed to a likelihood of success. Mineta, 319 F. Supp. 2d at 87; see Amoco

Prod. Co. v. Vill. of Gambell, 480 U.S. 531, 546 n.12 (1987) (“The standard for a preliminary

injunction is essentially the same as for a permanent injunction with the exception that the

plaintiff must show a likelihood of success on the merits rather than actual success.”); Nat’l

Mining Ass’n v. U.S. Army Corps of Eng’rs, 145 F.3d 1399, 1408–09 (D.C. Cir. 1998).

Accordingly, after declaring its conclusion that the Guidelines are invalid, this Court should also

grant permanent injunctive relief. This Court has already considered the requirements for

preliminary injunctive relief, after full briefing and oral argument, and those same considerations

support Plaintiffs’ request for permanent relief.

A. Plaintiffs Can Show Actual Success on the Merits

For the reasons set forth in sections II–IV above, Plaintiffs are entitled to a declaratory

judgment that the Guidelines are invalid under the Dickey-Wicker Amendment and/or were not

promulgated in accordance with the Administrative Procedure Act. Obviously, such a

declaration would constitute actual success on the merits for Plaintiffs. And when plaintiffs

“prevail[] on the merits, permanent injunctive relief is the appropriate remedy . . . .” Mineta, 319

F. Supp. 2d at 87.

B. Equitable Considerations Support Permanent Injunctive Relief

The equitable considerations for granting injunctive relief continue to support Plaintiffs’

request for a permanent injunction. Absent a permanent injunction, Drs. Sherley and Deisher

will continue to suffer irreparable harm. (See SOF ¶¶ 10–11.) Further, because the NIH

Guidelines are illegal, the balance of hardships and the public interest weigh heavily in favor of

granting Plaintiffs’ request for permanent injunctive relief. Only two weeks have passed since

this Court issued its preliminary injunction to prohibit Defendants’ ongoing violations of federal

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law and the equitable considerations have not changed in that short time. (See Pls.’ Memo. in

Opp’n to Defs.’ Mot. to Stay Order Pending Appeal, at 12–20 (discussing the factors supporting

a preliminary injunction which also counsel in favor of permanent injunctive relief) [Dkt. #51].)

In denying Defendants’ motion for a stay of the preliminary injunction, this Court made clear

that “Defendants are incorrect about much of their ‘parade of horribles’ that will supposedly

result from this Court’s preliminary injunction.” (Order of Sept. 7, 2010, at *1 [Dkt. #53].)

Twice this Court has examined the equitable considerations regarding injunctive relief, and both

times the Court has found that they favor Plaintiffs’ request for injunctive relief.

1. Plaintiffs Would Suffer Irreparable Harm Absent a Permanent Injunction

Drs. Sherley and Deisher would suffer irreparable injury absent a permanent injunction.

The NIH has a limited budget for funding scientific research that could lead to potentially life-

saving medical breakthroughs (see SOF ¶¶ 5, 10), and Plaintiffs—as well as other adult stem cell

researchers and the scientific community as a whole—must compete for those federal dollars

(see SOF ¶¶ 9–11). As the D.C. Circuit has recognized, Plaintiffs suffer immediate and legally

cognizable injury from being forced to compete with illegal grant applications, see Sherley, 610

F.3d at 70, 74, and they and other applicants should not have to face such illegal competition for

a single additional day. As this Court found in its August 23 decision, the Guidelines, “by

allowing federal funding of ESC research, increase[] competition for NIH’s limited resources.”

Sherley, 2010 U.S. Dist. LEXIS 86441, at *21. Therefore, adult stem cell researchers, such as

Drs. Sherley and Deisher, would suffer “actual, imminent injury” if federal dollars continued to

be diverted to embryonic stem cell research. Id. In addition, without a permanent injunction,

“[t]here is no after-the-fact remedy for this injury because the Court cannot compensate plaintiffs

for their lost opportunity to receive funds.” Id.; see also Indep. Bankers Ass’n of Am. v. Smith,

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534 F.2d 921, 951 (D.C. Cir. 1976) (“[w]ithout the prophylactic effect of the district court’s

injunction, each day [plaintiffs] would have suffered further economic and competitive

injury . . . .”).

The harm that will result absent a preliminary injunction is not merely pecuniary and is

not limited to the Plaintiffs that appear before the Court. To the contrary, if Defendants are

permitted to continue their illegal funding of human embryonic stem cell research under the

invalid Guidelines, all adult and induced pluripotent stem cell researchers and all other lawful

grant applicants for NIH research funding will continue to be forced to compete against illegal

research applications and will continue to be denied funding for their own research projects that

would otherwise have been funded—projects that could lead to potential cures and other medical

and scientific breakthroughs. (See SOF ¶¶ 10–11, 28(b), 28(n).) Failure to grant a permanent

injunction would also cause irreparable harm to American taxpayers, who would be forced to

continue funding research projects for which the people’s elected representatives have barred

federal funding in the Dickey-Wicker Amendment. Victims of disease and illness will continue

to suffer because they will be denied the results of the beneficial research that would have been

funded but for Defendants’ insistence on wasting federal tax dollars on speculative human

embryonic stem cell research that is highly unlikely to produce actual cures. (See SOF ¶¶ 28(b)–

(c), (e)–(f), (j)–(l), (n), (u)–(v), (y)–(ff).) Finally, the harm to the living human embryos that

could be destroyed absent a permanent injunction—precisely the harm that the Dickey-Wicker

Amendment was enacted to prevent—would be irreversible.

“Where [an] injury is both ‘threatened’ and ‘occurring’ at the time of the motion [for

injunctive relief] and plaintiff is successful on the merits,” the court should issue permanent

injunctive relief. Mineta, 319 F. Supp. 2d at 87. The actual and imminent injury suffered by

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Plaintiffs due to the continued illegal federal funding of embryonic stem cell research, along with

certain future injury absent an injunction, supports issuance of a permanent injunction.

2. The Balance of the Hardships Supports Permanent Injunctive Relief

As this Court previously found, the balance of the hardships also supports Plaintiffs’

request for injunctive relief. On the one hand, Drs. Sherley and Deisher (and all other adult and

induced pluripotent stem cell researchers and lawful NIH grant applicants) face a concrete and

significant competitive injury due to Defendants’ continued illegal funding of embryonic stem

cell research. On the other hand, Defendants can only allege highly “speculative” and uncertain

claims that individuals will be deprived of potential treatments developed through embryonic

stem cell research at some unarticulated time in the future, or that embryonic stem cell

researchers will seek other opportunities outside the United States. Sherley, 2010 U.S. Dist.

LEXIS 86441, at *21–22; see also Collins Decl. ¶¶ 5, 7, 12, 14.

Moreover, Defendants’ claims of harm to third parties (embryonic stem cell researchers

and persons seeking medical cures) rest on an utterly false dichotomy, namely the assumption

that there is no alternative to funding embryonic stem cell research. As the administrative record

in this case makes clear, however, there are such alternatives, including both adult and induced

pluripotent stem cell research, and those alternatives are more likely to result in cures for

debilitating diseases, and thus more likely to benefit patients. (SOF ¶¶ 28(b)–(l), 28(n), 28(q)–

(v), 28(y)–(ff), 54–59, 68–69.) Defendants cannot invoke such speculative, unlikely, and

contingent harms in opposition to Plaintiffs’ request for a permanent injunction.

In short, nothing has changed in the two weeks since this Court previously held that the

“balance of the hardships weighs in favor of an injunction.” Sherley, 2010 U.S. Dist. LEXIS

86441, at *21. And just two days ago, this Court reaffirmed that “Defendants are incorrect about

much of their ‘parade of horribles’ that will supposedly result . . . .” (Order of Sept. 7, 2010, at

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*1 [Dkt. #53].) Defendants have again failed to assert any concrete, tangible, or even likely

harms to tilt the balance of hardships in their favor, and thus permanent injunctive relief is

appropriate.

3. Permanent Injunctive Relief Would Serve the Public Interest

Finally, permanent injunctive relief is appropriate because an injunction would further the

public interest. “It is in the public interest for courts to carry out the will of Congress and for an

agency to implement properly the statute it administers.” Mylan Pharms., Inc. v. Shalala, 81 F.

Supp. 2d 30, 45 (D.D.C. 2000). As the D.C. Circuit held, “[e]very citizen of this country has an

interest in seeing [the] government carry out its legal duties . . . .” Cobell v. Kempthorne, 455

F.3d 301, 315 (D.C. Cir. 2006) (quoting district court below; internal quotations omitted). Under

binding D.C. Circuit precedent, an administrative action violating the clear will of Congress

cannot serve the public interest—“[s]uch a fait accompli is hardly in the public interest.” Indep.

Bankers Ass’n, 534 F.2d at 951. This factor carries considerable weight, because courts “must

pay particular regard to whether such relief would further the public interest.” Cobell, 455 F.3d

at 315.

As this Court held in granting Plaintiffs’ motion for a preliminary injunction, the Dickey-

Wicker Amendment clearly expresses Congress’ will to “prohibit federal funding of research in

which human embryos are destroyed.” Sherley, 2010 U.S. Dist. LEXIS 86441, at *17–19. In

denying Plaintiffs motion for a stay of the preliminary injunction, this Court held that allowing

the NIH Guidelines to continue in operation would “flout the will of Congress.” (Order of Sept.

7, 2010, at *1 [Dkt. #53].) “Congress has mandated that the public interest is served by

preventing taxpayer funding of research that entails the destruction of human embryos,” and

although Congress remains free to revise or amend the Dickey-Wicker Amendment, “[t]his

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43

Court is not free to do so.” (Id.) An injunction that permanently prohibits Defendants from

funding such research will “carry out the will of Congress” and thereby serve the public interest.

CONCLUSION

For the foregoing reasons, Plaintiffs’ motion for summary judgment should be granted,

and the Court should enter judgment (1) declaring that the Guidelines are vacated and invalid

because they are contrary to law, were promulgated without observing the procedures required

by law, and constitute arbitrary and capricious agency action, and (2) enjoining any further

implementation of the Guidelines.

Dated: September 9, 2010

Samuel B. Casey, Cal. Bar No. 76022 ADVOCATES INTERNATIONAL 9691 Main Street, Suite D Fairfax, VA 22031 (703) 894-1076

Steven H. Aden, D.C. Bar No. 466777 ALLIANCE DEFENSE FUND 801 G. Street N.W., Suite 509 Washington, D.C. 20001 (202) 393-8690

Respectfully Submitted, /s/ Thomas G. Hungar _ Thomas G. Hungar, D.C. Bar No. 447783 Bradley J. Lingo, D.C. Bar No. 490131 Thomas M. Johnson, Jr., D.C. Bar No. 976185 GIBSON, DUNN & CRUTCHER LLP 1050 Connecticut Avenue, N.W. Washington, D.C. 20036 (202) 955-8500

Blaine H. Evanson, Cal. Bar No. 254338 Andrew G. Pappas, Cal. Bar No. 266409 Michelle K. Pulley, Cal. Bar No. 266865 GIBSON, DUNN & CRUTCHER LLP 333 South Grand Avenue Los Angeles, CA 90071 (213) 229-7000


Supp. Add. 106




)))))

v. ))) ) )



Defendants.

))))))

PLAINTIFFS’ STATEMENT OF MATERIAL FACTS AS TO WHICH THERE IS NO GENUINE DISPUTE

1. Plaintiff Dr. James L. Sherley is an adult stem cell researcher. (Declaration of Dr. James L. Sherley in Support of Pls.’ Mot. for Summary Judgment (“Sherley Decl.”) ¶ 2.)

a. Dr. Sherley currently works at the Boston Biomedical Research Institute. (Sherley Decl. ¶ 2.)

b. Dr. Sherley does not conduct research on embryos or human embryonic stem cells. (Sherley Decl. ¶ 2.)

c. Dr. Sherley relies exclusively on research grants for funding. (Sherley Decl. ¶ 3.) The “vast majority” of grants he receives are from NIH. (Id.)

d. Since 1999, Dr. Sherley has applied for NIH funding approximately 42 times. (Sherley Decl. ¶ 3.)

e. Fourteen of Dr. Sherley’s research proposals have received NIH funding. (Sherley Decl. ¶ 3.)

f. Two of Dr. Sherley’s research proposals in which he is a principal investigator are currently pending. (Sherley Decl. ¶¶ 3, 4.)

g. Since 1999, Dr. Sherley has received only one significant private research award. (Sherley Decl. ¶ 3.)


Supp. Add. 107


h. Dr. Sherley has been a co-investigator on two other NIH grants providing minor funding for his adult stem cell studies. (Sherley Decl. ¶ 3.)

i. Dr. Sherley will continue to apply for NIH grants in the future. (Sherley Decl. ¶ 5; see also Sherley v. Sebelius, 610 F.3d 69, 71 (D.C. Cir. 2010) (attached as Declaration of Steven H. Aden in Support of Pls.’ Mot. for Summary Judgment (“Aden Decl.”), Ex. N).)

j. Dr. Sherley will likely be unable to continue his research without NIH funding. (Sherley Decl. ¶ 5.)

2. Plaintiff Dr. Theresa Deisher is an adult stem cell researcher. (Declaration of Dr. Theresa Deisher in Support of Pls.’ Mot. for Summary Judgment (“Deisher Decl.”) ¶ 2.)

a. Dr. Deisher is the founder, managing member, and research and development director of AVM Biotechnology. (Deisher Decl. ¶ 3.)

b. Dr. Deisher works exclusively with adult stem cells. (Deisher Decl. ¶ 2.)

c. Dr. Deisher does not conduct research on embryos or embryonic stem cells. (Deisher Decl. ¶ 2.)

d. Dr. Deisher can continue her research only if she obtains funding from NIH. (Deisher Decl. ¶ 3.)

e. Dr. Deisher is in the process of applying for NIH funding and will continue to seek NIH grants in the future. (Deisher Decl. ¶ 3; see also Sherley, 610 F.3d at 71 (attached as Aden Decl., Ex. N).)

3. Applicants for NIH research funding undergo evaluation through two-tier peer review. (Aden Decl., Ex. J [Decl. of Sarah Jean Rockey, Ph.D., in Support of Defs.’ Opp’n to Pls.’ Mot. for Prelim. Inj.] ¶ 8.)

4. A grant applicant submits the application to the Center for Scientific Review (CSR) at NIH; CSR then refers the application to one or more Institutes or Centers (ICs) at NIH depending on the subject area of the application. (Aden Decl., Ex. J ¶ 9.)

5. Each Institute or Center has “an independent budget” to fund research particular to its subject area. (Aden Decl., Ex. J ¶ 5.)

a. Congress sets each IC’s individual budget. (Aden Decl., Ex. J ¶ 15.)

b. Most ICs then establish a “‘payline’ for the overall amount they will spend on research grants. The ‘payline’ is a percentile-based funding cutoff point determined at the beginning of a fiscal year.” (Aden Decl., Ex. J ¶ 15.)

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c. “[S]tem cell research . . . is included within the overall payline and funded . . . according to the particular proposals received and the funding available to the particular IC.” (Aden Decl., Ex. J ¶ 16.)

d. “[I]n the short run, the amount of money available from NIH for research grants is fixed notwithstanding the greater range of stem cell projects made eligible for funding by the Guidelines.” Sherley, 610 F.3d at 73(attached as Aden Decl., Ex. N); see also Aden Decl., Ex. J at ¶¶ 15-16.

6. Each application receives a preliminary score; in general, only the applications in the top half of all preliminary scores are discussed at the first level of peer review. (Aden Decl., Ex. J ¶ 11.)

7. An application that is considered receives an actual score. (Aden Decl., Ex. J ¶ 11.) Based on this score “and the needs and mission of the particular funding component . . . , the Council or Board then recommends certain applications for funding.” (Id. ¶ 12.)

8. NIH “uses specific funding or ‘targeted’ announcements to stimulate research in particular areas of science through use of an announcement called a ‘Request for Applications’ (RFA).” (Aden Decl., Ex. J ¶ 6.)

9. The grant-application process is competitive, such that “[o]nly about 20 percent of applicants are successful in having their research proposals funded by NIH.” (Aden Decl., Ex. J ¶ 14.)

10. The NIH Guidelines for Human Stem Cell Research (“Guidelines”) “have intensified the competition for a share in a fixed amount of money.” Sherley, 610 F.3d at 74 (attached as Aden Decl., Ex. N); see also Sherley Decl. ¶ 5; Deisher Decl. ¶ 4.

11. As a result of the intensified competition caused by the Guidelines, “the plaintiffs will have to invest more time and resources to craft a successful grant application.” Sherley, 610 F.3d at 74 (attached as Aden Decl., Ex. N); see also Sherley Decl. ¶ 5; Deisher Decl. ¶ 4.

12. “[Adult stem cells] and [embryonic stem cells] are substitutes in some uses.” Sherley, 610 F.3d at 74 (attached as Aden Decl., Ex. N); see generally Aden Decl., Ex. D at 9-10.

13. The Dickey-Wicker Amendment provides that: “None of the funds made available in this Act may be used 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 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. No. 111-117, 123 Stat. 3034, 3280-81, § 509(a).

14. The Dickey-Wicker Amendment was enacted in direct response to efforts on the part of the National Institutes of Health (NIH) to begin funding research entailing the destruction of or undue risk to human embryos. (Aden Decl., Ex. D at 7.)

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15. In early 1993, NIH Director Harold Varmus convened the Human Embryo Research Panel, which recommended that NIH fund research entailing risks to human embryos. (See Aden Decl., Ex. D at 6.)

16. Before NIH could approve any grants for human embryonic stem cell research, Congress passed the Dickey-Wicker Amendment for the first time. (Aden Decl., Ex. D at E-6.)

17. Congress has included the Dickey-Wicker Amendment without material change in every Health and Human Services (“HHS”) appropriations bill since 1996. (See Aden Decl., Ex. D at 7-8; see also Defs.’ Memo. in Support of Mot. to Dismiss at 37 [Dkt. #23].)

18. NIH attempted to fund embryonic stem cell research in 2000, when it finalized and made effective “Guidelines for Research Using Human Pluripotent Stem Cells” (“2000 Guidelines”). 65 Fed. Reg. 51,976 (Aug. 25, 2000).

19. In 2001, NIH formally withdrew the 2000 Guidelines, which had never been implemented. 66 Fed. Reg. 57,107 (Nov. 14, 2001); Aden Decl., Ex. D at E-2.

20. Executive Order 13,505 provided that NIH “may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law,” and that “[w]ithin 120 days . . . [HHS and NIH] shall review existing NIH guidance and other widely recognized guidelines on human stem cell research . . . and issue new NIH guidance on such research that is consistent with this order.” 74 Fed. Reg. 10,667 (Mar. 11, 2009) (attached as Aden Decl., Ex. A).

21. The Executive Order also required that it “be implemented consistent with applicable law.” 74 Fed. Reg. 10,667 (Mar. 11, 2009) (attached as Aden Decl., Ex. A).

22. On April 23, 2009, NIH issued and requested comment on draft guidelines (“Draft Guidelines”) for human stem cell research. 74 Fed. Reg. 18,578 (Apr. 23, 2009) (attached as Aden Decl., Ex. B).

23. The Draft Guidelines’ stated purpose was “to help ensure that NIH-funded research [involving human embryonic stem cells] is ethically responsible, scientifically worthy, and conducted in accordance with applicable law.” 74 Fed. Reg. 18,578.

24. The Draft Guidelines proposed the authorization of federal funding of human embryonic stem cell research. 74 Fed. Reg. 18,578.

25. In a telephone briefing with reporters after the Draft Guidelines were issued, Acting NIH Director Raynard Kington stated: “We will expand greatly the number of cell lines eligible for funding . . . . We know of several hundred cell lines that will meet the guideline standards.” (Aden Decl., Ex. I [Gautam Naik, NIH Offers Rules for Embryonic Stem Cell Research, Wall St. J., Apr. 17, 2009].)

26. In response to the Draft Guidelines, Do No Harm, et al., submitted Comments that detailed numerous scientific flaws associated with human embryonic stem cell research. (Aden Decl., Ex. D.)

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27. Defendants received the Comments submitted by Do No Harm, et al., detailing the scientific problems associated with human embryonic stem cell research, and they are part of the administrative record. (Nat’l Institutes of Health, Listing of Comments on Draft NIH Human Stem Cell Guidelines, http://grants.nih.gov/stem_cells/web_listing.htm ?StartID=47017 (last visited Aug. 16, 2010).)

28. The administrative record establishes the following scientific facts, as shown by the Do No Harm Comments:

a. There are three general types of stem cells: embryonic, adult, and induced pluripotent. (See Aden Decl., Ex. D at 9-13.)

b. Adult stem cells “provide or promise to provide actual cell-based therapies that will lead to beneficial results for patients . . . .” (Aden Decl., Ex. D at 2.)

c. Adult stem cells have verifiably treated individuals suffering from a variety of diseases, including ovarian cancer, retinoblastoma, brain tumors, testicular cancer, chronic and acute leukemias, breast cancer, renal cell carcinoma, anemias, Crohn’s disease, rheumatoid arthritis, and juvenile diabetes. (Aden Decl., Ex. D at 9, G-4 to G-6)

d. Adult stem cells are found in the body and in tissues normally discarded after birth (such as umbilical cord blood and the placenta) that have the potential to generate most or all of the different tissues in the human body. (Aden Decl., Ex. D at 9.)

e. Adult stem cells can be harvested and grown in numbers sufficient for patient treatments. (Aden Decl., Ex. D at 9.)

f. Adult stem cells can provide matched tissue transplants, especially in the majority of cases where the patient’s own cells are used, and also in donor transplants. (Aden Decl., Ex. D at 9.)

g. “Some adult stem cells . . . show pluripotent flexibility in generation of tissues, meaning that they can generate most or all of the different tissues of the body.” (Aden Decl., Ex. D at G-1.)

h. Adult stem cells showing pluripotent flexibility have come from various sources, including bone marrow, peripheral blood, inner ear, umbilical cord blood, nasal mucosa, placental amniotic membrane, and testicular tissue. (Aden Decl., Ex. D at G-1 to G-2.)

i. “The true test of usefulness of any stem cell is not its pluripotency, but rather its ability for use in regenerative medicine, repairing damaged and diseased tissue and improving health.” (Aden Decl., Ex. D at G-2.)

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j. Adult stem cells show an ability to home in on damaged tissue, allowing development of minimally invasive administration techniques. (Aden Decl., Ex. D at G-8.)

k. Adult stem cells present no risk of tumor formation or immune-rejection. (Aden Decl., Ex. D at G-8.)

l. Adult stem cells have shown efficacy at repairing damaged and diseased tissue in numerous animal models of disease and injury. (Aden Decl., Ex. D at 10.)

m. Induced pluripotent stem cells provide an ethical alternative to human embryonic stem cells. (Aden Decl., Ex. D at 10.)

n. The exceptional promise of induced pluripotent stem cell research is well documented. (Aden Decl., Ex. D at H-1 to H-4.)

o. Induced pluripotent stem cells are produced by genetically reprogramming mature cells such that they are virtually indistinguishable from embryonic stem cells. (Aden Decl., Ex. D at H-1 to H-2.)

p. The process of producing human induced pluripotent stem cells was invented in November 2007. (Aden Decl., Ex. D at H-1.)

q. Induced pluripotent stem “cells from mice have already been used in proof-of-principle experiments to ameliorate disease in mouse models of sickle cell anemia, Parkinson’s disease, and murine hemophilia.” (Aden Decl., Ex. D at H-3.)

r. Induced pluripotent stem cells “can be created from virtually any cell type,” including “common fibroblast cells,” “plucked human hair,” and “human blood cells.” (Aden Decl., Ex. D at H-3.)

s. Induced pluripotent stem cells can be created more easily and less expensively than human embryonic stem cell lines. (Aden Decl., Ex. D at 10.)

t. Within a year after the announcement of the first human induced pluripotent stem cell lines, at least 315 human induced pluripotent stem cell lines were generated; over 500 induced pluripotent stem cell lines have now been reported. (Aden Decl., Ex.D at H-4.)

u. Induced pluripotent stem “cell lines from patients suffering from various diseases have been created, covering 13 different diseases.” (Aden Decl., Ex. D at H-4.)

v. Induced pluripotent stem cells can be created from a specific individual, allowing creation of patient-specific cell lines. (Aden Decl., Ex. D at 10.)

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w. Induced pluripotent stem cells “meet the defining criteria . . . originally proposed for human [embryonic stem] cells, with the significant exception that the [induced pluripotent stem] cells are not derived from embryos.” (Aden Decl., Ex. D at H-3.)

x. Human embryonic stem cells must be extracted from living human embryos. (See Aden Decl., Ex. D at E-3.)

y. Human embryonic stem cells will not lead to safe therapeutics because: they are not normal cells; they do not differentiate into desired adult phenotype cells, but to fetal, immature phenotype cells; they are not required for research using other pluripotent cells; and they will not cure the targeted diseases listed in the Draft Guidelines. (Aden Decl., Ex. D at 11-13.)

z. Embryonic stem cells have shown no success in therapeutic applications. (Aden Decl., Ex. D at G-1.)

aa. Tumor- or teratoma-formation is a “universal” and “innate” characteristic of human embryonic stem cells, and thus presents an “insurmountable hurdle” to therapeutic application. (Aden Decl., Ex. D at I-2.)

bb. Embryonic stem cells may form tumors when injected into a patient’s body. (Aden Decl., Ex. D at I-2 to I-3; see also Defs.’ Memo. in Support of Mot. to Dismiss at 3 [Dkt. #23].)

cc. Despite claims that differentiating embryonic stem cells prevents tumor-formation upon implantation, “[c]areful assessment of differentiated hESCs demonstrates . . . that even differentiated hESCs rapidly formed teratomas.” (Aden. Decl., Ex. D at I-2.)

dd. Several other therapeutic problems have been routinely observed with the use of differentiated embryonic stem cells for in vivo therapy. (Aden Decl., Ex. D at I-2 to I-3.)

ee. Embryonic stem cells may be rejected by a patient’s immune system. (See Aden Decl., Ex. D at G-8.)

ff. Embryonic stem cells are biologically inadequate replacements for lost adult stem cells. (See Aden Decl., Ex. D at I-1.)

gg. Embryonic stem cells “are neither useful nor required for research using other pluripotent stem cells.” (Aden Decl., Ex. D at 12.)

hh. Human embryonic stem cell research is scientifically unnecessary. (Aden Decl., Ex. D at 11, 18.)

29. In promulgating the Guidelines, Defendants failed to address or respond to the scientific problems identified in the Comments of Do No Harm, et al., and failed to explain

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30. In response to the Draft Guidelines, Do No Harm, et al., submitted Comments that detailed numerous ethical flaws associated with human embryonic stem cell research. (Aden Decl., Ex. D.)

31. Defendants received the Comments of Do No Harm, et al., detailing the ethical flaws associated with human embryonic stem cell research, and they are part of the administrative record. (Nat’l Institutes of Health, Listing of Comments on Draft NIH Human Stem Cell Guidelines, http://grants.nih.gov/ stem_cells/web_listing.htm? StartID=47017 (last visited Aug. 16, 2010).)

32. The administrative record establishes the following ethical flaws with the Guidelines, as shown by the Do No Harm Comments:

a. The Guidelines do not prevent conflicts of interest between the reproductive facility and the research facility. (Aden Decl., Ex. D at 13.)

b. By limiting federal funding to cell lines derived from embryos that are “no longer needed” for reproductive purposes, the Guidelines set the stage for abuse by infertility clinics. (Aden Decl., Ex. D at 13-14.)

c. The Guidelines completely disregard the unique status, worth, and life of human embryos, and unethically accord less protection to “unwanted” embryos. (Aden Decl., Ex. D at 14.)

d. Human embryos are living human beings and therefore deserve treatment commensurate with their status. (Aden Decl., Ex. D at 14, J-4.)

e. An international consensus recognizes that human embryos are biologically living human beings beginning at fertilization, and that human growth and development is a continuous physical process from the one-cell stage forward. (Aden Decl., Ex. D at J-4.)

f. Both the Human Embryo Research Panel and the National Bioethics Advisory Commission describe the human embryo from its earliest stages as a living organism and a “developing form of human life.” (Aden Decl., Ex. D at 14, J-4.)

g. In 1995, the historic and well-respected Ramsey Colloquium statement on embryo research acknowledges that “[t]he [embryo] is human; it will not articulate itself into some other kind of animal. Any being that is human is a human being.” (Aden Decl., Ex. D at J-4.)

h. Twenty-one states have fetal homicide statutes that apply without regard to gestational age. (Aden Decl., Ex. D at 8, B-1 to B-2.)

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i. Eight states have wrongful death statutes that apply regardless of gestational age. (Aden Decl., Ex. D at 8, B-3.)

j. In states that acknowledge and protect life from the moment of fertilization or conception, “donation” of human embryos for the purpose of destruction is viewed as a state criminal violation. (Aden Decl., Ex. D at 9; see generally id. at C-1 to C-18.)

k. The Guidelines wrongly assume that the biological parents of human embryos are legally and morally empowered to substitute their judgment for that of the human embryo in consenting to its destruction. (Aden Decl., Ex. D at 15-16.)

l. The Guidelines fail to require that parents receive sufficient information to be able to give truly informed consent. (Aden Decl., Ex. D at 16.)

m. Human embryonic stem cell research is categorically unethical. (Aden Decl., Ex. D at J-3 to J-5.)

n. Adult stem cell research is an ethically superior alternative to human embryonic stem cell research and a “worthy scientific priority meriting federal funding.” (Aden Decl., Ex. D at 9.)

33. In promulgating the Guidelines, Defendants failed to address or respond to the ethical concerns raised in the Comments of Do No Harm, et al., and failed to explain Defendants’ decision to authorize the federal funding of embryonic stem cell research in view of the ethical flaws Do No Harm identified. See 74 Fed. Reg. 32,170 (attached as Aden Decl. Ex. C).

34. The Do No Harm Comments also expressed concern that NIH Acting Director Raynard Kington had entered the rulemaking proceeding with “an unalterably closed mind” regarding the merits of the Guidelines and urged that he be excluded from the decisionmaking process. (Aden Decl., Ex. D at 19.)

35. Defendants received the comment referenced in ¶ 34, which is part of the administrative record. (Nat’l Institutes of Health, Listing of Comments on Draft NIH Human Stem Cell Guidelines, http://grants.nih.gov/stem_cells/web_listing.htm?StartID=47017 (last visited Aug. 16, 2010).)

36. Defendants ignored the comment referenced in ¶ 34 and failed to explain their decision to permit Acting Director Kington to participate in the decisionmaking process despite his professed bias and unalterably closed mind. See 74 Fed. Reg. 32,170.

37. NIH received 49,015 public comments on the Guidelines. (See Nat’l Institutes of Health, Listing of Comments on Draft NIH Human Stem Cell Guidelines, http://grants.nih.gov/stem_cells/web_listing.htm? (last visited Aug. 16, 2010).)

38. NIH disregarded as “unresponsive” about 30,000 such comments, which opposed federal funding for embryonic stem cell research on ethical and scientific grounds. (Aden. Decl.,

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a. Explaining NIH’s decision to disregard these comments, Acting NIH Director Raynard Kington stated, “We actually did not ask the public whether we should fund research on human embryonic stem cells. We asked the public how we should fund human embryonic stem cell research.” (Aden Decl., Ex. F at 2.)

b. Kington also stated, “We clearly predict that the opportunities for research will greatly expand” with respect to human embryonic stem cell research. (Aden Decl., Ex. F at 2.)

c. Kington’s statements regarding NIH’s decision to disregard comments opposed to embryonic stem cell funding were accurately reported in the article referenced in ¶ 38.

39. Defendants ignored comments addressing the merits of human embryonic stem cell research. (See Defs.’ Memo. in Support of Mot. to Dismiss at 44 [Dkt. #23] (NIH “properly ignored . . . the relative merits” of embryonic stem cell research); see also Defs.’ Reply in Support of Mot. to Dismiss at 20 [Dkt. #32] (“NIH responded appropriately to comments that were relevant to the formulation of the Guidelines, namely, comments that addressed the substance of the informed consent procedures that NIH proposed to establish.”).)

40. On July 7, 2009, NIH issued “Guidelines for Human Stem Cell Research,” which authorized federal funding of embryonic stem cell research utilizing live human embryos that were “created . . . for reproductive purposes” but are “no longer needed for [that] purpose.” 74 Fed. Reg. at 32,170, 32,174 (attached as Aden Decl., Ex. C).

41. The Guidelines require applicant institutions proposing research using human embryonic stem cells to ensure that the process by which the embryonic stem cells were derived from human embryos was in accordance with the Guidelines. 74 Fed. Reg. at 32,174-75 (attached as Aden Decl., Ex. C).

42. The Guidelines permit the same researcher both to derive stem cells from an embryo and to receive federal funding for all research activities involving those cells. 74 Fed. Reg. at 32,174 (“The attending physician responsible for reproductive clinical care and the researcher deriving and/or proposing to utilize [human embryonic stem cells] should not have been the same person unless separation was not practicable”) (attached as Aden Decl., Ex. C).

43. The Guidelines categorically prohibit the use of any funds for cloning or breeding of animals. 74 Fed. Reg. at 32,175 §§ IV, V (attached as Aden Decl., Ex. C).

44. The Guidelines categorically prohibit the offering of “payments, cash or in kind,” for “donated embryos.” 74 Fed. Reg. at 32,174 § II.A.3.b (attached as Aden Decl., Ex. C).

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45. The Guidelines regulate the process by which embryos must be obtained if they are to be used in government-funded research. 74 Fed. Reg. at 32,174-32,175 (attached as Aden Decl., Ex. C).

a. “[T]he Guidelines pertain primarily to the donation of embryos for the derivation of [human embryonic stem cells].” 74 Fed. Reg. 32,170 (attached as Aden Decl., Ex. C).

b. The Guidelines require that individuals donating “human embryos for research purposes” be informed of “[w]hat would happen to the embryos in the derivation of [the stem cells].” 74 Fed. Reg. at 32,174 (attached as Aden Decl., Ex. C).

c. “To conduct [embryonic stem cell] research, [embryonic stem cells] must be derived from an embryo. The process of deriving [embryonic stem cells] from an embryo results in the destruction of the embryo.” (Order of Aug. 23, 2010, at 12 [Dkt. #44]; see also Aden Decl., Ex. D at 5, E-3.)

46. In the Human Subject Protection Regulations, incorporated in the Dickey-Wicker Amendment, NIH defined “research” as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” 45 C.F.R. § 46.102(d); see also § 509(a)(2)(b), 123 Stat. at 3281.

47. HHS guidance documents on the Human Subject Protection Regulations state that an institution that receives federal funding is generally engaged in human subjects research “even where all activities involving human subjects are carried out by employees or agents of another institution.” (Dep’t of Health & Human Servs., Guidance on Engagement of Institutions in Human Subjects Research (Oct. 16, 2008), available at http://www.hhs.gov/ohrp/humansubjects/guidance/engage08.html.)

48. The Guidelines do not prohibit a privately funded researcher from destroying an embryo at a publicly funded researcher’s behest. See 74 Fed. Reg. at 32,174 (discussing limitations on eligibility for embryonic stem cell funding) (attached as Aden Decl., Ex. C).

49. Defendants never have set forth an interpretation of the word “research” as used in the Dickey-Wicker Amendment.

a. Defendants never have interpreted “research” to mean a “piece of research” in an official agency statement promulgated through notice-and-comment procedures.

50. The removal of the inner cell mass of a human embryo generates the embryonic stem cell, but in order to extract the stem cell, the human embryo must be destroyed. See 74 Fed. Reg. at 32,171 (defining human embryonic stem cells as “cells that are derived from the inner cell mass of blastocyst stage human embryos”) (attached as Aden Decl., Ex. C); Aden Decl., Ex. D at E-3 (“[t]he process by which human embryonic stem cells are extracted from human embryos necessarily destroys the human embryos”).

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51. Mouse embryonic stem cells were first isolated and successfully grown in the laboratory in 1981, while the first mouse adult stem cell was successfully isolated and purified in the laboratory in 1988. (Aden Decl., Ex. Q [Declaration of Dr. Theresa Deisher in Support of Pls.’ Opp’n to a Stay of the Prelim. Inj.] ¶ 7.)

52. Human embryonic stem cells were first isolated and grown briefly in the laboratory in 1994, and were first successfully maintained long-term in the laboratory in 1998. (Aden Decl., Ex. Q ¶ 7.)

53. The first human adult stem cell was first isolated in the laboratory in 1992. (Aden Decl., Ex. Q. ¶ 7.)

54. Although many researchers predicted that embryonic stem cell research would lead to the cure of diseases such as Parkinson’s, Alzheimer’s, and diabetes, those predictions have not come to pass. (Aden Decl., Ex. G [Bernadine Healy, M.D., Why Embryonic Stem Cells Are Obsolete, U.S. News & World Report, Mar. 4, 2009, http://health.usnews.com/blogs/heart-to-heart/2009/03/04/why-embryonic-stem-cells-are-obsolete.html]; see also Aden. Decl., Ex. D at A-2.)

55. No patients have been injected with human embryonic stem cells. (Aden Decl., Ex. Q. ¶ 11.)

56. Even many human embryonic stem cell research proponents are concerned that a clinical trial of a human embryonic stem cell-derived therapy is not safe to proceed despite having received FDA approval to begin enrolling certain patients. (Aden Decl., Ex. Q ¶11.)

57. As of September 3, 2010, 1,973 adult stem cell interventional trials were listed at ClinicalTrials.gov, a website developed and maintained by NIH. (Aden Decl., Ex. Q ¶ 12.)

58. As of September 3, 2010, zero interventional clinical trials with embryonic stem cells were listed on ClinicalTrials.gov. (Aden Decl., Ex. Q ¶ 12.)

59. The published literature contains . . . examples of adult stem cells that can differentiate into cell types different from their tissue of origin, including recently-discovered very small embryonic-like (‘VSEL’) cells from adult bone marrow, and demonstrates that these bone marrow-derived cells can repair cardiac damage. (Aden Decl., Ex. Q ¶ 14.)

60. Bone marrow stem cells can form neurons, as even NIH as noted. (Aden Decl., Ex. Q ¶ 15.)

61. Adult neural stem cells can be obtained from the post-mortem human brain and yield nerve cells. (Aden Decl., Ex. Q ¶ 16.)

62. The technique used to generate induced pluipotent stem cells was originally discovered using knowledge from mouse embryonic stem cells; that same technique was used to create the first human induced pluripotent stem cell. (Aden Decl., Ex. Q ¶ 17.)

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63. Recently published literature confirms that human embryonic stem cells and induced pluripotent stem cells are “virtually identical.” (Aden Decl., Ex. Q ¶ 18 & n.21.)

64. Induced pluripotent stem cells probably avoid rejection by the immune system. (Nat’l Institutes of Health, Stem Cell Basics 14 (2009), available at http://stemcells.nih.gov/ staticresources/info/basics/SCprimer2009.pdf; see also Aden Decl., Ex. D at 10.)

65. Standard cell culture technique involves freezing (cryopreservation) of cell stocks from the very inception of a cell culture and cell line. (Aden Decl., Ex. Q. ¶ 19.)

66. Cryopreserved cells are stored in liquid nitrogen at –196° C, at which temperature they can be maintained indefinitely; methods have been refined specifically for human embryonic stem cells. (Aden Decl., Ex. Q ¶ 19.)

67. In 2006, a total of 50,417 transplants were performed worldwide using hematopoietic (blood-forming) adult stem cells. (Aden Decl., Ex. Q ¶ 20.)

a. Almost half (48%) of such transplants took place in Europe. (Aden Decl., Ex. Q ¶ 20.)

b. Only 36% took place in all of the Americas. (Aden Decl., Ex. Q ¶ 20.)

68. Adult stem cell transplants have become the standard of care for many patients with blood disorders and malignancies, though they are starting to be used for other conditions including autoimmune disorders and heart disease. (Aden Decl., Ex. Q ¶ 20.)

69. Adult stem cell therapy is an accepted therapy worldwide. (Aden Decl., Ex. Q ¶ 20.)

Dated: September 9, 2010

Samuel B. Casey, Cal. Bar No. 76022 ADVOCATES INTERNATIONAL 9691 Main Street, Suite D Fairfax, VA 22031 (703) 894-1076

Steven H. Aden, D.C. Bar No. 466777 ALLIANCE DEFENSE FUND 801 G. Street N.W., Suite 509 Washington, D.C. 20001 (202) 393-8690

Respectfully Submitted, /s/ Thomas G. Hungar _ Thomas G. Hungar, D.C. Bar No. 447783 Bradley J. Lingo, D.C. Bar No. 490131 Thomas M. Johnson, Jr., D.C. Bar No. 976185 GIBSON, DUNN & CRUTCHER LLP 1050 Connecticut Avenue, N.W. Washington, D.C. 20036 (202) 955-8500

Blaine H. Evanson, Cal. Bar No. 254338 Andrew G. Pappas, Cal. Bar No. 266409 Michelle K. Pulley, Cal. Bar No. 266865 GIBSON, DUNN & CRUTCHER LLP 333 South Grand Avenue Los Angeles, CA 90071 (213) 229-7000

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in the united states court of appeals for the district...

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