UNITED STAT ES DIS TRICT COURT F OR THE DIS TRICT OF COLUM BIA

__________________________________________ ) DR. J AMES L . SHERL EY, et al. , ) ) Plaintiffs, )

) v. ) Civ. No. 1:09-cv-1575 (RCL ) ) ) KATHL EEN SEBE L I US, et al. , ) ) Def endants. ) __________________________________________) MEMORAN DUM OP INION I. INTRODUCTION This matter come s befor e the Court on plaintiffs’ Motion [3] for a Preliminary

Injunction. Previously , this Court di smissed this case for lack of standing and denie d plaintiffs’ motion for a preliminary

injunction as moot. P laintiffs appe aled. On a ppeal, plaintiffs a

rgued that plaintiffs Drs. Shere ly

and Dieshe r had c ompetitor standing a nd conce ded that other

plaintiffs lacke d standing . The Court of Appe als reve rsed, holdingthat plaintiffs Sherley and Dieshe r have standing , and re manded the matter to this Court for consideration of plaintiffs’ motion for a preliminary

injunction. The mandate from the Court of A ppeals wa s filed in this Court t his date. For the re asons set for

th below, the Court will GRANT plaintiffs’ motion and issue a preliminary

injunction. II. BACK GR OUND A. Procedural History Plaintiffs Drs. J ames L . Sherley and The resa

Deisher , Nig htlight Christian Adoptions (“N ightlig ht”), Embryos, Shay ne and T ina Nelson, Willi am and Patric ia Fly nn, and ChristianMedica l Association (“CMA” ) broug ht this sui t for dec laratory and injunctive re lief to preve nt defe ndants’ Guidelines f

or Human Stem Cell Resear ch (“ Guidelines”) from takingeff ect. (Compl.¶¶ 4, 6-12.) Spec ifically , plaintiffs soug ht “an or der ( a) de clar ing tha t the Guidelines ar e contra ry to law, wer e promulg ated without observingthe proc edure s require d by law, and constitute arbitra

ry and ca pricious ag ency

action; and ( b) enjoining [d] efe ndants from a pply ing the Guidelines or othe rwise f unding r esea

rch involving the destruc tion of human embryonic stem cells.” ( Id. ¶ 4.) On O ctober

27, 2009, this Court di smissed plaintiffs’ suit, finding that plaintiffs lacke d standing , and denie d plaintiffs’ motion for a pr eliminary injunction as moot. Sherley v. Sebelius , 686 F. Supp. 2d 1, 5-7 (D .D.C. 2009). Plaintiffs appea led. The Court of Appe als reve rsed, c oncluding that Drs. Sherle y and De isher had sta

nding under the competitor standingdoctrine. Sherely v. Sebe lius , – F.3d –, 2010 WL2540358, *5 (D.C. Cir. 2010). B eca

use the Nig htlight, the Embryos, the Nelsons, the F ly nns, and CMA did not contest this Court’s finding that they lacke d standing , the Court of Appe als treated “their lack of standing as conc eded.” Id. at *2. The Court of A ppeals then r emande d this matter back to this Court for conside ration of plaintiffs’ motion for a pre liminary injunction. Id. at *6. B. Stem Cell Research Stem cell rese arc h has the potential to produc e medica l breakthroug hs in the treatment of many life-thre atening

diseases a

nd conditions that have re sisted traditional methods of treatment. (Pls.’ Mot. [ 3] for Prelim. I nj. at 2; Defs.’ Opp’n [22] at 2.) The re a re thre e ty pes of stem c ells available for r esea

rch: a dult stem cells (“ASCs”), induce d pluripotent stem cells (“I PSC s”), a nd human embryonic stem ce lls (“ESCs”). (Pls.’ Mot. [ 3] for Prelim. I nj. at 2.) Eac h ty pe of stem cell possesses unique capa biliti es and limitations. (Def.’ s Opp’n [22] at 3.) As a result, many

2scientists believe that re sear ch should be c onducted on e ach ty pe of stem c ell. (

Id. (citing Nat’l I nsts. of Hea lth, Stem Cell Information: Freque ntly Asked Q uestions , http:// stemcells.nih.g ov/info/faqs.asp) .) Other scientists, however , believe that resea rch should be conduc ted only

on ASCs and I PSC s beca use ESC resea

rch ha s not produced positive re sults and is morally

objectionable. ( Pls.’ Mot. [ 3] for Prelim. I nj. at 2-3.) ESCs have bee n available for r esea rch since 1998, when Dr . J ames Thomson of the University

of Wisconsin discovered a proce ss for der iving stem c ells from an e mbryo. ( Id. at 3.) ESCs are pluripotent, i.e , they have “ the ca

pability to give rise to any

of the a pproxi mately

200 ty pes of c ells in the human body .” (D ef.’ s Opp’n [22] at 3.) Onc e they are derive d from an embryo, ESCs m ay

be maintained inde finitely

. See Nat’l I nsts. of Hea lth, Stem Cell Information: Frequently A sked Q uestions , http:// stemcells.nih.g ov/info/faqs.asp. ESCs m ay

be used to tre at disease s in two way s. First, re sear cher s can tra nsplant ESCs into patients. ( See Def

s.’ Opp’n [22] at 3.) To transplant ESCs, resea rche rs must guide the differ entiation of ECSs into certain kinds of ce lls. ( Id. ) Diff ere ntiation of ESCs reduces the r isk of benig n tumor forming afte r the ESCs are transplanted. ( Id. (citing Nat’l Ac ads., Understanding Stem Cells: An Ov ervie w of the Scienceand the Issues from the National Acade mies at 5 (2009)) .) Second, ESCs may be used to “ study

disease me chanisms that ca nnot be studied in the human body , and to deve lop other, non-stem-c ell based the rapie s for these conditions.” (De fs.’ Opp’ n [22] at 4.) Rec ent studies employing both methods of tr eatment sug g est that ESCs will contribute to the de velopment of medic al knowledg e in the future . ( See id. ) ASC resea

rch, in whic h Drs. Sherle y and De isher spec ialize, is approx imately fifty y ear s 3old and beg an with the discove ry of hematopoietic stem cells. ( Id. ) ASCs are f

ound in tissues that are normally

discarde d afte r birth, such a s the umbilical cord, a nd in the body . (Pls.’ Mot. [3] for Pre lim. I nj. at 3.) B eca use re sear cher s have be en able to study ASCs for deca des, they have be en able to develop tre atments for nume rous disease s with ASCs . ( Id. ; Defs.’ Opp’n [22] at 5.) ASCs, howeve r, ar e limited beca use, unlike ESCs, they

are multipot ent, not pluripotent. (De fs.’ Opp’ n [22] at 5 (c iting Nat’l I nsts. of Hea lth, Hematopoietic Ste m Cells , http:// stemcells.nih.g ov/info/scireport/cha pter5.a sp).) As a

result, ASCs cannot diffe rentiate into the 200 ty pes of c ells in the human body . ( Id. ) Ne verthe less, ASC resea rch r emains of g reat importance in the treatment of disease . ( Id. at 6.) I PSC rese arc h is the newe st form of stem ce ll resea rch. D iscovere d in 2007, I PSC s “ar e adult stem cells that have been g enetica lly repr og rammed suc h that they are virtually

identical to embryonic stem ce lls.” (Pls.’ Mot. [ 3] for Prelim. I nj. at 4.) B eca use re sear ch involving IPSC s is at such a n ear ly stag e, its full potential is unknown. (Def s.’ Opp’n [22] at 5.) Some resea rche rs, howeve r, believe that I PSC s offe rs the most promise for a dvance ments in medical re sear ch and treatment. (Pls.’ Mot. [ 3] for Prelim. I nj. at 4-5.) C. Regulatory Backgroun d I n 1996, Congr ess ena cted the B alanc ed B udg et Downpa y ment Act, Pub. L . No. 104-99, § 128, 110 Stat. 26, 34 (1996). The B alanc ed B udg et Downpa y ment Act conta ined a r ider, known as the D ickey -Wicker Ame ndment, which prohibited the use of fe dera l funds for “ (1) the

cre ation of a huma

n embryo or embryos for re sear ch purpose s; or (2) r esea rch in whic h a human embryo or embryos are destroy ed, disca rded, or knowing ly

subjected to risk of injury or death g reater than tha

t allowed for

rese arc h on fetuses in utero under” applicable fede ral re g ulations.

4Id. Congr ess has include d the Dicke y -Wicker Ame ndment in ever y appropr iations bill for He alth and Human Ser

vices (“ HHS”) since 1996 without substantive alteration. See Omnibus Appropriations Act 2009, Pub. L . No. 111-8, § 509(a )(2) , 123 Stat. 524, 803 (2009). I n 1999, defe ndants deter mined that the Dicke y -Wicker Ame ndment was not applica ble to ESC resear ch bec ause ESCs are not embry os as def ined by statute. ( See L ingo D ecl. Ex. D.) Specifica lly , defe ndants rec og nized a distinction between de riving ESCs from an embryo, which is prohibited by

the Dicke y -Wicker Ame ndment beca use it results in the destruction of the embryo, and re sear ch on ESCs, which does not re sult in t he destruc tion of an embryo. See Nat’l I nsts. of Hea lth Guidelines for Huma n Stem Cell R esea

rch, 74 F ed. Reg . 32170, 32173 (Jul y 7, 2009). De fenda

nts have maintaine d this int erpr etation of the D ickey -Wicker Ame ndment since 1999. ( Id. ) Cong ress, howe ver, ha s not altered the Dickey -Wicker Ame ndment in response. (De fs.’ Opp’ n [22] at 9-10.) On August 9, 2001, President Bush a nnounced a

policy statement on stem ce ll resea rch that limit ed fe dera l fundingfor r esea rch on ESCs. See Addre ss to Nation on Stem C ell Resear ch Fr om Crawfor d Texas, 37 Weekly Compl. P res. Doc . 1149 (Aug . 9, 2001). Specific ally , the President prohibited fe dera l funding for r esea rch on ESCs that wer e cr eate d afte r the da te of the policy statement. (

Id. ) F eder al fundingrema ined ava ilable, howeve r, for rese arc h on ESCs t hat

wer e cr eate d by

private r esea

rche rs prior to his policy

statement. (

Id. ) The Pre sident formalized this poli cy

statement in Executive Orde r No. 13,435, whic h provided fe dera l fundingfor I PSC

rese arc h and lef

t the limit ations on ESC resear ch uncha ng ed. See Ex ec. O rder

No. 13,435, 72 Fe d. Reg . 34,591 (June 20, 2007). On Marc h 9, 2009, President Obama , by executive orde r, re moved President B ush’s

5limit ations on ESC resear ch in orde r “to e x pand NI H support” f or human stem ce ll resea

rch a nd “to enha nce the contribution of Amer ica’ s scientists to important newdiscoverie s and new thera pies for the benef

it of humankind.” Executive Orde r No. 13,505, 74 F ed. Reg . 10,667 (Mar

. 9, 2009) As a re sult, the National I nstitut es of He alth (“N I H”) “may support and conduc t responsible, scie ntifically worthy human stem ce ll resea

rch, inc luding human e mbryonic stem

rese arc h, to the extend permitted by law.” Id. To ac hieve that e nd, the President dire cted NI H to revie w the existi ng stem cell re sear ch guidelines and “ issue new NI H g uidance on such re sear ch that is consistent with thi s order .” Id. I n response to President Obama’ s executive order , NI H published draf t guide lines entitled “National I nstitut es of He alth Guidelines for Human Stem Cell Researc h.” 74 F ed. Reg . 18,578 (Apr. 23, 2009) . The dra ft g uidelines allowed “ funding for r esea rch using human embryonic stem cells that wer e der ived from human e mbry os cre ated by in vitro fer tiliz ation (IVF) for repr oductive purpose s and we re no long er ne eded f or that purpose .” Id. NI H re ceive d approximately

49,000 comments, including plaintiffs’ submission, on the draft guidelines during the comment per iod. 74 Fed. Re g . at 32,170. Afte r re viewingthe comments, NI H published its final Guidelines on human ste m cell re sear ch on Jul y , 7 2009. The Guide lines set forth elig ibilit y require ments to determine whic h ESC li nes “c ould be used in rese arc h funded by NI H.” ( Def

s.’ Opp’n [22] at 8.) I f a r esea rch a pplicant proposes

rese arc h on ESCs derived af ter the e ffe ctive date of the Guide lines, the applica nt must use either ESCs t hat ar e posted on the N I H re g istry , or submit an assura nce of compliance with require ments contained w ithin S ection I I (A) of the Guidelines. 74 F ed. Reg . at 32,174. Section I I (A) r equire s that rese arc h involves only ESCs t hat wer e der ived from human e mbry os that
6“we re c reated using in vitro fer tiliz ation for r eproduc tive purposes a nd wer e no long er ne eded f or this purpose” a

nd “we re dona

ted by the individuals who sought r eproduc tive treatment . . . and who g ave voluntar

y written conse nt for the human e mbry os to be used for rese arc h purposes.” Id. Section I I (A) f

urther r equire s documentation of the f ollowing: (a ) that “[a]ll opt ions available in the health ca

re f acility wher e tre atment was soug ht pertainingto the embryos no longe r nee ded for r eproduc tive purposes we re e x plained to the individual(s) who soug ht reproduc tive treatment”; (b) that no pa y ments were offe red f

or the e mbry os; (c) that the health ca re f acility has proce dures in plac e to ensure that the quality of ca re pr ovided to potential donors would not be aff ecte d by their conse nt or ref

usal to donate e mbry os; (d) that there was a “cle ar se paration” betwee n the donor’s de cision to create the embr y os for re productive pur

poses and the donor ’s decision to donate the embryos for re sear ch; and ( e) that donors wer e provide d with cer tain information duringthe conse nt proce ss. Id. I f a r esea rch a pplicant proposes r esea

rch on ESCs derive d befor e the e ffe ctive date of the Guidelines, the a

pplicant must use either ESCs that are posted on the NI H re g istry , or establish funding elig ibilit y

in one of two wa

y s: the applicant may

either c omply

with Section I I (A), or submit m ater ials to a Working Gr oup of the Advisory Commi ttee to the Dire ctor of N I H, which will make re commendations re g arding funding elig ibilit y . Id. at 32,175. I f an a pplicant submits materia ls to the W orking Group, the a pplicant must demonstrate that the ESCs wer e der ived from embr

y os that were cre ated using in vitro fer tiliz ation, that the embryos were no longe r neede d for r eproduc tive purposes, a nd that the donors g ave voluntar y written conse nt that their embryos could be used f

or re sear ch. Id. I n addition, the Working Gr oup will consider the f actor s contained in Sec tion I I (A). Id.

7Finally , the Guidelines provide that “NI H fundingof the de rivation of stem ce lls from

human embryos is prohibited by ” the Dic key -Wicker Ame ndment. Id. Thus, acc ording to defe ndants, the Guidelines “ rec og nize the disti nction . . . betwee n the der ivation of stem cells from an e mbry o that results in the embryo’s destruc tion, for which F eder al fundingis prohibited, and re sear ch involving hE SCs t hat does not involve an e mbryo nor re sult in an embry o’s destruction, for

which F eder al fundingis permitted.” Id. at 32,173. III. LEGAL STANDARD A pre liminary

injunction is “an extraordinary reme dy that should be g rante d only when the par ty seekingthe re lief, by

a cle ar showing , car

ries the bur den of pe rsuasion. Cobell v. Norton , 391 F.3d ( 251, 258 (D.C. Cir. 2004). A pa rty car ries this burden of

persua sion by establishing: ( 1) that there is a substantial likelihood of succe ss on the merits; (2) that the plaintiff would suffe r irre para ble injury absent a n injunction; (3) that an injunction would not substantially

injure other inter ested pa rties; and (4) that an injunction would further public interest. Mova Pharm . Corp. v. Shalala , 140 F.3d 1060, 1066 ( D.C. Cir. 1998) (quoting CityFed Fin. Corp. v. Office of Thrift Supervision , 58 F.3d 738, 746 ( D.C. Cir. 1995)). The Court eva luates these f actor s on a “sliding scale .” Davis v. Pe nsion Benefit Guar. Corp. , 571 F.3d 1288, 1291 ( D.C. Cir. 2009). Under this approac h, the Court balanc es the fac tors ag ainst eac h other to dete rmine whe ther the pla intiff has shown that “a ll four fa ctors, taken tog ether , weig h in favor of the injunction.” Id. at 1292. Thus, a pa rticularly strong showing on one fa ctor may offse t a wea

ker showingon another

fac tor. See id. at 1291-92 (“ I f the movant makes a

n unusually

strong showing on one of the fac tors, then it does not nece ssarily have to make as stronga showingon another fac tor.”). T he plaintiff, howe ver, must show at
8least some injury to warr ant the pre liminary injunction because “the ba sis for injunctive re lief in the fe dera l courts has a lway s been irr epar able ha rm.” CityFed Fin. Corp. , 58 F.3d at 747. IV. ANALYSIS The Court finds that the likelihood of succ ess on the mer its, irrepar able ha rm to plaintiffs, the balanc e of ha

rdships, and public intere st considerations each w eig h in favor of a pre liminary injunction. See W

inter v. Natural Res. Def. Counsel, Inc. , 129 S. Ct . 365, 374 (2008). Acc ording ly , the Court will GRANT plaintiffs’ motion and issue the pre liminary injunction. A. Likelihood of Su cce ss Plaintiffs assert two indepe ndent ar g uments as to why they are likely to succe ed on the merits. First, they

arg ue that the Guide lines violate the plain languag e of the Dickey -Wicker Amendment. Second, the y contend that, in promulg ating the Guidelines, de fenda nts violated the Administrative Procedur e Ac t (“APA” ). B eca use the Court conc ludes that plaintiffs have demonstrated a

strong likelihood of succe ss that the Guidelines violate the D ickey -Wicker Amendment, the Court nee d not addre ss whether defe ndants violated the APA. 1. The Dicke

y-Wicke r Am endm ent Is Unam biguou s Def endants a rgue that the Dic key -Wicker Ame ndment is ambiguous. Spec ifically , they argue that the ter

m “re sear ch” is ambiguous, a nd that, as a r esult, their interpre tation of rese arc h should be entitled to Chevron defe renc e. See Che vron U.S.A., I nc., v. Natural Resource

s Defense Counsel, Inc. , 467 U.S. 837, 843 (1984). De fenda nts’ argument fails. Under Chevron , the Court must first ask whether Congr ess has “ direc tly

spoken to the prec ise question at issue.” Id. at 842. I f it has, the Court must “g ive ef fec t to the unambiguously expressed intent of Cong ress.” Id. at 843. I f, howe ver, the “the statute is silent or ambiguous
9with respec t to the specific issue,” then the Court def ers to the NI H’s interpr etation provided it is “base d on a per

missibl e construc tion of the statute.” Id. Congr ess has spoken to the pr ecise question at issue—whethe r fe dera l funds may be used for r esea rch in whic h an embr

y o is destroy ed. The Dickey -Wicker Ame ndment provides that no fede ral funds sha ll be used for “re sear ch in which a

human embryo or embryos are destroy ed, discarde d, or knowing ly

subjected to risk of injury or dea th gr eate r than that a llowed for r esea rch on fetuses in utero under 45 C.F .R. § 46.204(b) and se ction 498(b) of the Public Health Servic e Act (42 U .S.C. 289g(b) ).” Pub. L . No. 111-8, § 509(a )(2) . Thus, as demonstrated by the plain lang uag e of the statute, the unambig uous intent of Congr ess is to prohibit the ex penditure of fede ral funds on “ rese arc h in which a human e mbry o or embryos are destroy ed.” Id. Contrary to defe ndants’ ar g ument, the term “ rese arc h” as use d in the Dickey -Wicker Amendment has only

one mea ning, i.e. , “a sy stematic investig ation, including r esea rch development, testingand eva luation, desig ned to deve lop or contribute to g ener alizable knowledg e.” 45 C.F .R. § 46.102(d); see also Random House Dict. ( listi ng the first def inition of

rese arc h as “dilig ent and sy stematic inquiry or investig ation into a subject in order to discover or revise f acts, theor ies, applications, etc.”). T his is the mostcommon definition of re sear ch, and no other de finition of resea rch is supported by

the languag e of the statute. The languag e of the statute does not support def endants’ a lternative de finition of resea rch as “a piece of re sear ch.” ( Def .’s Opp’n [22] at 31 (citing R A N D O M H O U S E D I C T . (2009).) I ndeed, the Dickey -Wicker Ame ndment does not contain a ny languag e to support such a limit ed definition of re sear ch. Rather , the languag e of the statute ref lects the unambiguous intent of Congr ess to enac t a broa d prohibition of funding rese arc h in which a human e mbry o is destroy ed.
10This prohibition encompasses all “re sear ch in which” an embr y o is destroy ed, not just the “piec e of re sear ch” in whic h the embryo is destroy ed. Ha d Congr ess intended to limit the Dickey

Wicker to only

those discre te ac ts that result in the destruction of a n embryo, like the der ivation of ESCs, or to resea

rch on the embryo itself, Congr ess could have written the statute that wa y . Congr ess, howeve r, has not wr itten the statute that way , and this Court is bound to apply the law as it is written. Acc ording ly , this Court m ust “g ive ef fec t to the unambiguously expressed intent of Cong ress” to prohibit feder al fundingof re sear ch in which a human embryo is destroy ed. Chevron , 467 U.S. at 843. 2. The Guidelines V iolate the Dickey- Wicker Am endm ent Havingconclude d that the Dicke y -Wicker Ame ndment is unambiguous, the que stion befor e the Court is whethe r ESC resea rch is re sear ch in which a human embryo is destroy ed. The Court conc ludes that it is. Def endants a rgue that the ESC rese arc h is not resea rch in whic h a human e mbry o is destroy ed bec ause ESC rese arc h does not involve embry os nor re sult in t heir de struction. This argument rests on def

endants’ inter

preta tion of “re sear ch,” a s used in the Dicke y -Wicker Amendment, to mean “ a piec e of r esea rch.” (De fs.’ Opp’ n [22] at 31 (c iting R A N D O M H O U S E D I C T . (2009).) This interpretation allows defenda nts to define ESC resea

rch a nd the der ivation of ESCs from embryos as sepa rate and distinct “piec es of r esea rch.” Thus, the Guidelines,

acc ording to defe ndants, are consistent with Dickey -Wicker Ame ndment beca use the Guide lines only allow fundingof ESC resea rch, a nd not the derivation of ESCs, which results in the destruction of a

n embryo. Def endants’ a

rgument is unavailing . Their e ntire ar g ument assumes that the Dic key

11Wicker Amendme nt is ambiguous and that, as a re sult, they are entitled to Chevron defe renc e. As discussed above , defe ndants’ assumption is incorre ct. The D ickey -Wicker Ame ndment unambig uously

prohibits the use of fe dera l funds for a ll resea rch in whic h a human e mbry o is destroy ed. It is not l imited to prohibit fede ral fundingof only the “piec e of r esea

rch” in which an embryo is destroy ed. Thus, if ESC rese arc h is resea rch in whic h an embr

y o is destroy ed, the Guidelines, by

funding ESC resear ch, violate the D ickey -Wicker Ame ndment. ESC resear ch is clea

rly rese arc h in which an e mbry o is destroy ed. To c onduct ESC

rese arc h, ESCs m ust be derive d from an e mbry o. The proc ess of de riving ESCs from an embryo results in the destruc tion of the embryo. Thus, ESC resear ch nec essar ily depends upon the destruction of a

human embryo. Despite de fenda

nts’ attempt to separate the der ivation of ESCs from resea rch on the ESCs, t he two ca

nnot be sepa

rate d. Der ivation of ESCs from an embryo is an integ ral step in conductingESC resear ch. Indeed, it is just one of many steps in the “sy stematic investig ation” of stem cell re sear ch. 45 C.F.R. § 46.102(d) . Simpl y beca use ESC resea

rch involves multiple steps does not mean that eac h step is a sepa rate “piec e of r esea

rch” that may

be fe dera lly

funded, provided the step doe s not result in the destruction of a n embryo. I f one step or

“piec e of

rese arc h” of a

n ESC resear ch proje ct re sults in t he destruc tion of an embryo, the entire projec t is prec luded from r ece iving f eder al fundingby

the Dicke y -Wicker Ame ndment. Be cause ESC

rese arc h require s the derivation of ESCs, ES C resea rch is re sear ch in which a n embryo is destroy ed. Ac cording ly , the Court conclude s that, by allowing fede ral fundingof ESC resea rch, the Guidelines a

re in violation of the Dic key -Wicker Ame ndment.

% % % 12I n sum, plaintiffs have de monstrated a stronglikelihood of succe ss on the merits. The

Dickey -Wicker Ame ndment is unambiguous. It prohibits resear ch in which a human embryo is destroy ed, disca

rded, or knowing ly

subject to risk of injury

or dea th gr eate r than that a llowed under a pplicable r egulations. The Guidelines violate that prohibition by allowing fede ral funding of ESC resea

rch be cause ESC resear ch depe nds up on the destruc tion of a human e mbry o. B. Irreparable Inju ry This Circuit has established a hig h standard f or irre para

ble injury

. Chapliancy of Full Gospel Churches v . England , 454 F.3d 290, 297 ( D.C. Cir. 2006). First, a pla intiff must alleg e an injury that is “both cer

tain and great; it m ust be ac tual and not theore tical.” Id. (quoting W isc. Gas Co. v. FERC , 758 F.2d 669, 674 ( D.C. Cir. 1985). The a lleg ed injury must be “of suc h imminence that there is a ‘cle ar a nd prese nt’ nee d for e quitable re lief to preve nt irrepa rable harm.” Id. (citation omitted). Second, the pla intiff’s alleg ed injury “must be beyond

reme diation.” Id. Plaintiffs Sherley and De isher have met this high burde n. Plaintiffs are r esea

rche rs who wor

k exclusively

with ASCs. They

seek f unds for their

rese arc h projec ts from defe ndants and a lleg e “that obtaining NI H fundingis nece ssaryfor their continued re sear ch.” ( Pls.’ Mot. [ 3] at 44.) The Guidelines, by allowing fede ral fundingof ESC

rese arc h, incre ases c ompetition for NI H’s limited resourc es. This incre ased c ompetition for limit ed funds is an a ctual, imminent injury

. See She rely , 2010 WL 2540358 at *5 (e x plaining that the incre ased c ompetition that plainti ffs fa ce is “ substantial enoug h to deem the injury to them imminent”). Ther e is no afte r-the- fac t remedy for this injury

beca use the Court ca

nnot compensate plaintiffs for

their lost opportunity

to rec eive f

unds. See B racco D iagnostics, Inc. v. Shalala , 963 F. Supp. 20, 29 (D.D .C. 1997) (quoting Hoffman-Laroche I nc. v. Califano , 453 F.
13Supp. 900, 903 (D.D.C. 1978) (statingthat even if an injury is economic in nature , the injury may be irre para

ble if “the re is ‘no a dequate compensatory or other c orre ctive re lief’ that c an be provided at a later

date” ). Ac cording ly , plaintiffs would suffe r irre para ble injury in the absenc e of the injunction. C. Balan ce of

Hardshi ps The ba lance of har dships weig hs in favor of an injunction. Def

endants a rgue that two interested pa

rties would be injure d if the Court issues an injunction: ESC resear cher s and individuals who suffer

from disea ses that may

be tre atable in the f

uture a s a re sult of ESC

rese arc h. The Guide lines g ive ESC resea rche rs, like plaintiffs, the opportunity to compete f

or NI H funding . The injunction, howeve r, would not seriously harm ESC rese arc hers be cause the injunction would sim ply

prese rve the status quo and would not interfe re w ith their ability to obtain private f

unding f or their r esea

rch. In addition, the harm to individuals who suffe r fr om diseases that one day

may be tre atable a s a re sult of ESC resear ch is speculative. I t is not certain whether ESC resear ch will result in new a nd succe ssful treatments for diseases suc h as Alzheimer’s and Par

kinson’s disease. Plaintiffs’ injury

of incre ased c ompetition, however, is not spec ulative. It is actual and imminent. I ndeed, the Guidelines threaten the ver y livelihood of plaintiffs Sherley and De isher. Acc ording ly , the irre para

ble har m that plaintiffs would suffer absent the injunction outweig hs the harms to intere sted parties. D. Public Int

erest Finally , the public intere st weig hs in favor of a pre liminary

injunction. “I t is in t he public interest for

courts to ca

rry out the will of Congr ess and f or an a g ency

to implement properly

the

14statute it administers.” Mylan Pharms. I nc. v. Shalala , 81 F. Supp. 2d 30, 45 (D.D .C. 2000). Her e, the will of Cong ress, a s expressed in the Dicke y -Wicker Ame ndment, is to prohibit federa l funding of re sear ch in which human e mbry os are destroyed. Ac cording ly , it is i n the public interest to enjoin def

endants fr om implementing the Guide lines beca use the Guide lines allow fede ral fundingof ESC resea rch, w hich involves the destruc tion of embryos. V. CONCLUSION Plaintiffs have e stablished that the pre liminary injunction factors—the likelihood of

succe ss on the merits, irrepa rable injury , the balanc e of ha rdships, and the public intere st—weig h in favor of

a pre liminary

injunction. Accor dingly , the Court will GRANT plaintiffs’ motion [ 3] for a preliminary

injunction. A separate orde r shall issue this date.

Signed by Roy ce C. L amber

th, Chief J udg e, on August 23, 2010.

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