09-- }~ JUL 0No. I}8-

OFfiCe. OF THE CLERK

IN THE

D reme � eut’t et the i ttitel Dtate

PFIZER INC.,

V.

Petitioner,

RABI ABDULLAHI, et al.,Respondents.

On Petition for a Writ of Certiorari to theUnited States Court of Appeals

for the Second Circuit

PETITION FOR A WRIT OF CERTIORARI

July 8, 2009

KATHLEEN M. SULLIVANCounsel of Record

FAITH E. GAYSANFORD I. WEISBURSTWILLIAM B. ADAMSQUINN EMANUEL URQUHART

OLIVER & HEDGES, LLP51 Madison Avenue22nd FloorNew York, NY 10010(212) 849-7000

Counsel for Petitioner

WILSON-EPES PRINTING CO., INC. - (202) 789-0096 - WASHINGTON, D. C. 20002

QUESTIONS PRESENTED

In the midst of an unprecedented bacterial me-ningitis epidemic in Nigeria, petitioner Pfizer Inc.("Pfizer") conducted a clinical trial of an antibioticmedication. Respondents filed suit in two UnitedStates district courts, invoking federal subject matterjurisdiction under the Alien Tort Statute ("ATS"),28 U.S.C. 1350. The complaints alleged that Pfizerhad violated international law by failing to obtainadequate consent from patients. They alleged thatthe Nigerian government assisted generally in theimportation of the medicine and provision of hospitalfacilities, but not that the government knew of orparticipated in the failure to obtain adequate con-sent. The questions presented are:

1. Whether ATS jurisdiction can extend to a pri-vate actor based on alleged state action by a foreigngovernment where there is no allegation that thegovernment knew of or participated in the specificacts by the private actor claimed to have violatedinternational law.

2. Whether, absent state action, a complaint that aprivate actor has conducted a clinical trial of amedication without adequately informed consent cansurmount the "high bar to new private causes ofaction" under the ATS that this Court recognized inSosa v. Alvarez-Machain, 542 U.S. 692, 727 (2004).

(i)

iiPARTIES AND RULE 29.6 STATEMENT

Petitioner, Pfizer Inc. ("Pfizer"), was the defendantin the consolidated district court actions and was theappellee in the Second Circuit. Pfizer has no parentcompany, and no publicly held company owns 10% ormore of Pfizer’s stock.

Respondents, individuals, were the plaintiffs in theconsolidated district court actions and were theappellants in the Second Circuit. They are:

Rabi Abdullahi, individlaally and as the naturalguardian and personal[ representative of theestate of her daughter Lubabatau Abdullahi

Salisu Abullahi, individually and as the naturalguardian and personal representative of theestate of his son Abulliahi (Manufi) Salisu

Alasan Abdullahi, individually and as the natu-ral guardian and personal representative of theestate of his daughter Firdausi Abdullahi

Ali Hashimu, individually and as the naturalguardian and personal[ representative of theestate of his daughter Suleiman

Muhammadu Inuwa, individually and as the nat-ural guardian and personal representative of theestate of his son Abdullahi M. Inuwa

Magaji Alh Laden, individually and as the natu-ral guardian and personal representative of theestate of his son Kabiru [syaku

Alhaji Mustapha, individually and as the naturalguardian and persona], representative of theestate of his daughter A~,~ma’u Mustapha

iiiSuleiman Umar, individually and as the naturalguardian and personal representative of theestate of his son Buhari Suleiman

Haji Abdullahi, individually and as the naturalguardian of Zainab Abdu, a minor

Abdullahi Madawaki, individually and as thenatural guardian of Firdausi Abdullahi, a minor

Sani Abdullahi, a minor, by his father and natu-ral guardian, Sani Abdullahi

Aisha Ado, individually and as the natural guar-dian of Abdullahi Ado, a minor

Abdumajid Ali, a minor, by his father and natu-ral guardian, Alhaji Yusuf Ali

Muhammad Ali, individually and as the naturalguardian of Nura Muhammad Ali, a minor

Malam Badamasi Zubairu, individually and asthe natural guardian of Umar Badamasi, a minor

Alhaji Danaldi Ibrahim, individually and as thenatural guardian of Muhammadu Fatahu Danladi,a minor

Malam Gwammaja, individually and as the natu-ral guardian of Dalha Hamza, a minor

Mukhtar Saleh, individually and as the naturalguardian of Tasiu Haruna, a minor

Tijjani Hassan, individually and as the naturalguardian of Muhyiddeen Haasan, a minor

Kawu Adamu Ibrahim, a minor, by his fatherand natural guardian, Malam Abamus IbrahimAdamu

Alhaji Ibrahim Haruna, individually

iv

Mallam Idris, individually

Idris Umar, individual.ly and as theguardian of Yusuf Idris, a minor

Isa Muhammed Isa, individually and as thenatural guardian of Hafsat Isa, a minor

Malam Isa Usman, individually and as the natu-ral guardian ofTaju Isa, a minor

Isyaku Suaibu, individually and as the naturalguardian of Hadiza Isyaku, a minor

Jafaru Baba, individually and as the naturalguardian of Zahra’u Jafaru, a minor

Malam Mohammed, individually and as thenatural guardian of Anas Mohammed, a minor

Yahawasu Muhammed, individually and as thenatural guardian of Nafisatu Muhammed, aminor

Muhsinu Tijjani, a minor, by his father andnatural guardian, Tijjani Hassan

Alhaji Yusuf Ali

Maryam Idris, a minor, by her father and natu-ral guardian, Malam Idris

Ajudu Ismaila Adamu, individually and as par-ent and natural guardian of Yahaya Ismaiea,minor

Malam Mohammed, individually and as parentand natural guardian of Bashir Mohammed,minor

Malam Yusab Ya’u Amale, individually and asparent and natural guardian of Suyudi YusalsYu’a, minor

natural

V

Malasm Haruna Adamu, individually and asparent and natural guardian of MohammedTasi’u Haruna, minor

Zangon Kwajalawa, individually and as parentand natural guardian of Nuruddim Dauda, minor

Malam Dahauru Ya’y, individually and as parentand natural guardian of Rabi Dahuru, minor andas parent and natural guardian of Zainab MusaDahuru, minor

Zangon Marikita, individually and as parent andnatural guardian of Ismaila Musa, minor

Arhaji Muihammad Soja, individually and asparent and natural guardian and personal repre-sentative of estate of Hamaza Achaji Muhammad,minor, deceased

Achaji Ibrahim Dankwalba, individually and asparent and natural guardian of Personal Repre-sentative of estate of Abdullahi Ibrahim, minor

Mallam Lawan, individually and as parent andnatural guardian and personal representative ofestate of Aisha Lawan, minor, deceased

Alhaji Muhammed Tsohon Sojo, individuallyand as parent and natural guardian andpersonal representative of estate of Unni AlhasiMuhammed, minor

Ismaila Zubairui, individually and as parent andnatural guardian and personal representative ofestate of Mustapha Zubairu, minor, deceased

Abubaker Musa, individually and as parent andnatural of Sa’adatu Musa, minor

Mohamed Abdu, individually and as parent andnatural guardian of Haruna Abdu, minor

viMallam Hassan, individually and as parent andnatural guardian and personal representative ofestate of Sadiya Hassan, minor, deceased

Mallam Yakubu Umar, individually and as par-ent and natural guardian of Abubakar Yakubu,minor

Mallam Samaila, individually and as parent andnatural guardian ofAdamu Samalia, minor

Musa Yahaya, individually and as parent andnatural guardian of Ukb~Lasa Musa, minor

Audu Ismailia Adamu, individually and as par-ent and natural guardian ofYashaya Samaila

Malam Musa Dahiru, irLdividually and as parentand natural guardian of Zainabu Musa, minor

Malam Musa Zango, individually and as parentand natural guardian of Samaila Musa, minor

Mallam Alhassan Maihula, individually and as aparent and natural guardian of Najib Maihula,minor

Mallam Abdullah Garna, individually and asparent and natural guardian of Dankuma Gama,minor

Dauda Nuhu, individually and as parent andnatural guardian and personal representative ofestate of Hamisu Nuhu, minor, deceased

Mallam Abdullahi, individually and as parentand natural guardian and personal representa-tive of estate of Najaratu Adbullahi, minor,deceased

Malam Umaru Mohamtned, individually and asparent and natural guardian and personal rep-

vii

resentative of estate of Sule Mohammed, minor,deceased

Mallam Nasiru, individually and as parent andnatural guardian and personal representative ofestate of Yusif Nasiru, minor, deceased

Yusuf Musa, individually and as parent andnatural guardian and personal representative ofestate of Nafisatu Musa, minor, deceased

Mallam Muritala, individually and as parent andnatural guardian and personal representative ofestate of Umaru Muritala, minor, deceased

Mallam Tanko, individually and as parent andnatural guardian and personal representative ofestate of Madina Tankol, minor, deceased

Mallam Sheu, individually and as parent andnatural guardian and personal representative ofestate of Madina Tankol, minor, deceased

Malam Kabiru Mohamed, individually and asparent and natural guardian and personal rep-resentative of estate of Kabiru Mohamed, minor,deceased

Mallam Sule Abubakar, individually and as par-ent and natural guardian and personal repre-sentative of estate of Fatima Abubaker, minor,deceased

Mallam Idris, individually and as parent andnatural guardian and personal representative ofestate of Baba Idris, minor, deceased

Mallam Mohamed Bashir, individually and asparent and natural guardian and personal rep-resentative of estate of Sani Bashir, minor,deceased

oooVlll

Ibrahim, individually and as parent and naturalguardian and personal representative of estate ofHassan Ibrahim, minor, deceased

Alhaji Shuaibu, individually and as parent andnatural guardian and personal representative ofestate of Masjbatu Shuaibu, minor, deceased

Mallam Abdullahi Sale, individually and as par-ent and natural guardian and personal repre-sentative of estate of Shamisiya Sale, minor,deceased

Mallam Ibrahim Amyarawa, individually and asparent and natural guardian and personalrepresentative of esta~e of Yahaya Ibrahim,minor, deceased

Mallam Abdu Abubaker, individually and asparent and natural guardian and personal repre-sentative of estate of Nasitu Abubaker, minor,deceased

Mallam Yusuf, individually and as parent andnatural guardian and personal representative ofestate of Hodiza Yusuf, minor, deceased

Mallam Dauda Yusuf, irLdividually and as parentand natural guardian and personal representa-tive of estate of Abubaker Sheu, minor, deceased

Maliam Mohammed Sheu, individually and asparent and natural guardian and personal repre-sentative of estate of Mustapha Yakubu, minor,deceased

Alhaji Ubah, individually and as parent andnatural guardian and personal representative ofestate of Maryam Ubah, minor, deceased

ix

Mallam Mohamadu Jabbo, individually and asparent andnatural guardian of AuwaluMohamadu

Mallam Abdullah Adamu, individually and asparent and natural guardian and personalrepresentative of estate of Abdullah Adamu,minor, deceased

Blank Page

TABLE OF CONTENTS

Page

QUESTIONS PRESENTED ................................ i

PARTIES AND RULE 29.6 STATEMENT ......... ii

PETITION FOR A WRIT OF CERTIORARI ...... 1

OPINIONS BELOW ............................................ 1

JURISDICTION .................................................. 2

STATUTORY PROVISION INVOLVED ............ 2

STATEMENT ...................................................... 2

REASONS FOR GRANTING THE WRIT .......... 10

I. THE SECOND CIRCUIT’S DECISIONEXPANDING ATS JURISDICTION ISIN TENSION WITH THIS COURT’SDECISION IN SOSA AND CONFLICTSWITH DECISIONS OF OTHER CIR-CUITS ........................................................12

A. The Second Circuit’s Decision Con-flicts With Decisions Of OtherCircuits As To The Degree Of StateAction Required For An ATS Claim ...14

B. The Second Circuit’s Decision Con-flicts With Decisions Of OtherCircuits As To The Scope Of Cus-tomary International Law NormsApplicable To Purely Private Actors ..19

(xi)

xii

TABLE OF CONTENTS--Continued

Page

II. THE SECOND CIRCUIT’S EXPAN-SION OF ATS JURISDICTION OVERAMERICAN CORPORATIONS DOINGBUSINESS ABROAD RAISES ISSUESOF NATIONAL AND INTERNATION-AL IMPORTANCE .................................... 25

CONCLUSION .................................................... 29

APPENDICES

APPENDIX A, Abdullahi v. Pfizer, Inc.,562 F.3d 163 (2d Cir. Jan. 30, 2009) ...............la

APPENDIX B, Abdullahi v. Pfizer, Inc.,No. 05-4863-cv(L) (2d Cir. Apr. 9, 2009) .........107a

APPENDIX C, Abdullahi v. Pfizer, Inc.,No. 01 Civ. 8118 (WHP), 2005 WL 1870811(S.D.N.Y. Aug. 9, 2005) ....................................114a

APPENDIX D, Adamu v. pfizer, Inc.,399 F. Supp. 2d 495 (S.D.N.Y. Nov. 8, 2005)..153a

APPENDIX E, Complaint, Abdullahi v. Pfizer,Inc., filed Aug. 28, 2001 (S.D.N.Y.) .................175a

APPENDIX F, Complaint, Adamu v. Pfizer, Inc.,filed Nov. 27, 2002 (D. Conn.) ..........................290a

Xlll

TABLE OF AUTHORITIES

CASES Page

Abagninin v. AMVAC Chemical Corp.,545 F.3d 733 (9th Cir. 2008) .... 15, 16, 19, 21, 23

Abdullahi v. Pfizer, Inc., No. 01 Civ. 8118(WHP), 2002 WL 31082956 (S.D.N.Y.Sept. 17, 2002) ........................................... 3

Aldana v. Del Monte Fresh Produce,N.A., Inc., 416 F.3d 1242 (11th Cir.2005) ............................................... 16, 17, 19, 24

American Isuzu Motors, Inc. v. Ntsezeba,128 S. Ct. 2424 (2008) ...............................11

Ammend v. Bioport, 322 F. Supp. 2d 848(W.D. Mich. 2004) .....................................21

Ashcroft v. Iqbal, 129 S. Ct. 1937 (2009) .....15, 27Barrios- Velazquez v. Asociacion de

Empleados del Estado Libre Asociado dePuerto Rico, 84 F.3d 487 (1st Cir. 1996)..16

Beanal v. Freeport-McMoRan, Inc., 969 F.Supp. 362 (E.D. La. 1997) .........................18

Bell Atlantic Corp. v. Twombly, 550 U.S.544 (2007) ..................................................15, 27

Blum v. Yaretsky, 457 U.S. 991 (1982) ........17Brentwood Academy v. Tennessee Second-

ary Sch. Athletic Ass’n, 531 U.S. 288(2001) .........................................................17

Cisneros v. Aragon, 485 F.3d 1226 (10thCir. 2007) ...................................................23

Conway v. A.I. DuPont Hosp. for Children,No. 04-4862, 2007 WL 560502 (E.D. Pa.Feb. 14, 2007) ............................................22

Cornish v. Correctional Servs. Corp., 402F.3d 545 (5th Cir. 2005) ............................17

Crissman v. Dover Downs Enter., Inc., 289F.3d 231 (3d Cir. 2002) .............................17

xiv

TABLE OF AUTHORITIES--Continued

Page

Dura Pharms., Inc. v. Broudo, 544 U.S.336 (2005) ...................................................27

Flores v. S. Peru Copper Corp., 414 F.3d233 (2d Cir. 2003) ......................................8, 21

Guaylupo-Moya v. Gonzales, 423 F.3d 121(2d Cir. 2005) ............................................21

Hoover v. W. Va. Dep’t of Health & HumanServs., 984 F. Supp. 978 (S.D.W. Va.1997) ..........................................................22

Igartua-De La Rosa v. United States, 417F.3d 145 (lst Cir. 2005) ............................21, 28

HT v. Vencap, 519 F.2d 1001 (2d Cir.1975) ..........................................................21

Jaffee v. United States, 663 F.2d 1226 (3dCir. 1981) ...................................................22

Kadic v. Karadzic, 70 F.3d 232 (2d Cir.1995) ..................................................... 16, 20, 23

Khulumani v. Barclay Nat’l Bank Ltd.,504 F.3d 254 (2d Cir. 2007) ......................11

Merrill Lynch, Pierce, Fenner & Smith,Inc. v. Dabit, 547 U.S. 71 (2006) ..............27

Oetjen v. Central Leather Co., 246 U.S. 297(1918) .........................................................28

Padilla-Padilla v. Gonzales, 463 F.3d 972(9th Cir. 1996) ...........................................21

Prosecutor v. Tadic, IT-94-1-T, Judgment,~[ 654 (May 7, 1997) ..................................23

Robertson v. McGee, No. 01-cv-60, 2002WL 535045 (N.D. Okla. Jan. 28, 2002) ....21

Romero v. Drummond Co., 552 F.3d 1303(llth Cir. 2008) .................................... 17, 18, 19

Sosa v. Alvarez-Machain, 542 U.S. 692(2004) ........................................................ passim

XV

TABLE OF AUTHORITIES--Continued

Page

Taveras v. Taveraz, 477 F.3d 767 (Gth Cir.2007) ..........................................................24

Vietnam Ass’n for Victims of Agent Orangev. Dow Chem. Co., 517 F.3d 104 (2d Cir.2008) ..........................................................20

White v. Paulsen, 997 F. Supp. 1380 (E.D.Wash. 1998) ...............................................21

STATUTES & RULES

28 U.S.C. 1254(1) .......................................... 228 U.S.C. 1350 ...........................................2, 10, 1928 U.S.C. 1350 note ......................................1742 U.S.C. 1983 ..............................................16, 17FED. R. CIV. P. 8(a)(2) ...................................15

OTHER AUTHORITIES

Jack L. Goldsmith & Alan O. Sykes, LexLoci Delictus & Global Economic Welfare:Spinozzi v. ITT Sheraton Corp., 120HARV. L. REV. 1137 (2007) ........................ 26

Gary Clyde Hufbauer & Nicholas K.Mitrokostas, AWAKENING N[ONSTER: THE

ALIEN TORT STATUTE OF 1789 (2003) ........ 25

Nigeria Sues Drugs Giant Pfizer, BBCNews Online, June 5, 2007 .......................9

RESTATEMENT (THIRD) OF FOREIGN RELA-

TIONS LAW § 404 (1986) ............................. 20RESTATEMENT (THIRD) OF FOREIGN

RELATIONS LAW § 702 (1986) ......... 16, 19, 20, 24Armin Rosencranz & Richard Campbell,

Foreign Environmental & HumanRights Suits Against U.S. CorporationsIn U.S. Courts, 18 STAN. ENVTL. L. J.145 (1999) ..................................................27

xviTABLE OF AUTHORITIES--Continued

Statute of the International Court ofJustice art. 38, June 26, 1945, 59 STAT.1031, 33 U.N.T.S. 993 ...............................

Melissa A. Waters, Mediating Norms &Identity: The Role of TransnationalJudicial Dialogue In Creating & Enforc-ing International Law, 93 GEO. L.J. 487(2005) .........................................................

Page

26

IN THE

No. 08-

PFIZER INC.,

V.

Petitioner,

RABI ABDULLAHI, et al.,Respondents.

On Petition for a Writ of Certiorari to theUnited States Court of Appeals

for the Second Circuit

PETITION FOR A WRIT OF CERTIORARI

Petitioner, Pfizer Inc. ("Pfizer"), respectfully peti-tions for a writ of certiorari to review the judgment ofthe United States Court of Appeals for the SecondCircuit in this case.

OPINIONS BELOW

The opinion of a divided panel of the Second Circuit(Pet. App. 1a-106a) is reported at 562 F.3d 163. Oneopinion of the district court (Pet. App. 114a-152a) isavailable at 2005 WL 1870811, and a second opinionof the district court (Pet. App. 153a-174a) is reportedat 399 F. Supp. 2d 495.

2

JURISDICTION

The Second Circuit issued its decision on January30, 2009. Pet. App. 6a. Pfizer’s petition for rehearingand rehearing en banc was denied on April 9, 2009.Pet. App. 112a. This Court has jurisdiction under 28U.S.C. 1254(1).

STATUTORY PROVISION INVOLVED

The Alien Tort Statute ("ATS"), 28 U.S.C. 1350,provides: "The district courts shall have originaljurisdiction of any civil action by an alien for a tortonly, committed in violation, of the law of nations or atreaty of the United States."

STATEMENT

In the decision below, the Second Circuit dramat-ically expanded ATS jurisdiction by allowing twocomplaints to proceed against an American corpora-tion for conducting a clinical trial of an antibioticmedication in Nigeria, allegedly without obtainingadequate consent as required by international law.In so doing, the Second .Circuit disregarded thisCourt’s caution in Sosa v. A~varez-Machain, 542 U.S.692, 727 (2004), that there should be a "high bar tonew private causes of action" under the ATS. TheSecond Circuit also created two circuit conflicts: (1)its decision sets a much lower bar for alleging stateaction under the ATS than the Fifth, Ninth, andEleventh Circuits have req~Lired; and (2) its decisiontakes a much broader view than the Sixth, Ninth,Tenth, and Eleventh Circuit~ have taken of the kindsof ATS causes of action that may proceed againstpurely private actors. This Court should grant certi-orari to resolve these conflicts and to give much-needed guidance to the lower courts in the appli-

3cation of Sosa to ATS lawsuits against Americancorporations that do business abroad.

1. In 1996, Pfizer administered the new antibioticTrovan to children in Kano, Nigeria, in the midst ofan unprecedented outbreak of cerebospinal menin-gitis ("CSM"). Trovan had been tested previously inthousands of adult patients. In administering themedicine to ill children, Pfizer allegedly failed toadvise that some would receive Trovan, and others (acontrol group) would receive an established compara-tor treatment. Pfizer also allegedly failed to advise ofpossible risks associated with either type of treat-ment, and to provide fully adequate care.

2. Respondents, allegedly participants in the clini-cal trial and/or their representatives, filed suits intwo federal district courts invoking ATS jurisdiction.In August 2001, one set of respondents (Abdullahiet al.) filed suit in the U.S. District Court for theSouthern District of New York, alleging that Pfizer’sclinical trial violated international law.1 In Novem-ber 2002, a second set of respondents (Adamu et al.)filed suit in the U.S. District Court for the District ofConnecticut, alleging jurisdiction under the ATS ongrounds of international law as well as under twoConnecticut state statutes. The Adamu action wastransferred to the Southern District of New York andconsolidated with the Abdullahi action.

The complaints, although lengthy, each made onlya few brief references to the Nigerian govern-

1 The Abdullahi case was initially dismissed on the ground offorum non conveniens, Abdullahi v. Pfizer, Inc., No. 01 Cir. 8118(WHP), 2002 WL 31082956, at "12 (S.D.N.Y. Sept. 17, 2002),but that dismissal was vacated and remanded for further fact-finding, 77 Fed. Appx. 48, 53 (2d Cir. 2003).

4ment’s supposed assistance to Pfizer. The Abdullahicomplaint alleged that the Nigerian government"provid[ed] the requisite request for a clinical trialletter to the FDA," and "arrang[ed] for Pfizer’s accom-modation in Kano." ~108 & n.6 (Pet. App. 237a). TheAdamu complaint alleged that "the Nigerian dicta-torship at the time was intimately involved andcontributed, aided, assisted and facilitated Pfizer’sefforts to conduct the Trovan test," ~[ 21 (Pet. App.312a), and that the "Nigerian government acted inconcert with Pfizer by ... assigning Nigerian physi-clans to assist in the project," ~ 6(h) (Pet. App. 299a).Neither complaint, however, alleged any specific factsthat would support an infierence that the Nigeriangovernment knew of or participated in the specificconduct alleged to violate international law, namelyPfizer’s supposed failure to obtain adequately in-formed consent to Trovan’s administration.2

2 Plaintiffs’ only other allegations of state involvement were

similarly vague and general. For example, plaintiffs allegedthat the Nigerian government silenced critics of the drug trial.E.g., Adamu ~[~[ 6(h), 40 (Pet. App. 299a, 321a); Abdullahi~ 108 n.6, 147 (Pet. App. 237a, 252a). But plaintiffs did notallege that such critics were specifically addressing the admin-istration of Trovan without adequate consent. Moreover, bothcomplaints describe "silencing" as mere self-censorship by thecritics out of a sense that the Nigerian dictatorship then inpower would not tolerate public criticism, not as an active tacticby that regime.

Plaintiffs also alleged that, in response to a 1997 FDA audit,a letter from the ethics committee at the hospital where theclinical trial was held, stating tha:~ it had "reviewed Pfizer’s testplans," was back-dated. Abdullahi ~ 133 (Pet. App. 244a). Buteven if the committee were a state actor (which is not alleged)and even if such a letter was later created and back-dated, thisallegation does not suggest that the Nigerian government, at the

53. The district court (Pauley, J.) dismissed the

Abdullahi action for lack of subject matter jurisdic-tion under the ATS, reasoning that "[a] cause ofaction for Pfizer’s failure to get any consent, informedor otherwise, before performing medical experimentson the subject children would expand customaryinternational law far beyond that contemplated bythe ATS." Pet. App. 141a (internal quotation marksomitted). Several months later, the district courtdismissed the Adamu action based on the samereasoning. Pet App. 163a.3

4. A divided panel of the Second Circuit reversed.The panel majority (Parker, J., joined by Pooler, J.)held that a clinical trial conducted without adequateconsent violates eight supposed sources of customaryinternational law: (1) the International Covenant onCivil and Political Rights ("ICCPR"), (2) a 1997Council of Europe convention, (3) a 2001 directive ofthe European Parliament, (4) a 2005 UNESCO dec-laration, (5) the Declaration of Helsinki issued by theWorld Medical Association, (6) the InternationalEthical Guidelines for Research Involving HumanSubjects promulgated by the Council for Interna-tional Organizations for Medical Sciences, (7) severalcountries’ domestic laws, and (8) the NurembergCode. Pet. App. 26a-43a. The panel majority furtherconcluded that these sources of a norm against non-consensual clinical trials were "sufficiently specific,

time of the Trovan trial, knew of or participated in the allegedlack of informed consent.

3 The district court held, in the alternative, that the actionsshould be dismissed for forum non conveniens, finding thatNigeria was an adequate alternative forum. Pet. App. 170a.Pfizer did not rely on forum non conveniens as a basis for affir-mance on appeal.

6universally accepted, and obligatory for courts torecognize a cause of action ~o enforce the norm" with-in the meaning of the ATS. Pet. App. 49a.

The panel majority devoted only three paragraphsof its opinion to the question of state action. Startingfrom the premise that "a private individual will beheld liable under the ATS if he ’acted in concert with’the state, i.e., ’under color of law,’" Pet. App. 50a, thepanel majority found state action adequately pleaded,noting respondents’ allegations "that the Nigeriangovernment provided a letter of request to the FDA toauthorize the export of Trovan, arranged for Pi~zer’saccommodations in Kano, and facilitated the noncon-sensual testing." Pet. App. 50a-51a.

The panel majority suggested, in the alternative,that administering a clinical trial without adequateconsent would give rise to a cause of action under theATS even if brought against a purely private actorwithout any state involvement. The majority heldthat Pfizer is bound by the Nuremberg Code prin-ciple that "[t]he voluntary consent of the humansubject is absolutely essential," Pet. App. 21a, eventhough that principle was announced as a result ofcriminal verdicts against state actors who were partof the governmental machinery of the Third Reich(the one non-state defendant tried at Nuremberg wasacquitted), see Pet. App. 92a n.17 (dissent). And themajority held that Article 7 of the ICCPR, whichprovides that "no one shall be subjected without hisfree consent to medical or scientific experimentation,"is "not limited to state actors; rather, it guaranteesindividuals the right to be free from nonconsensualmedical experimentation by any entity--state actors,private actors, or state and private actors behaving inconcert." Pet App. 32a, 33a (emphasis added).

7

Accordingly, the panel majority reversed andremanded for further proceedings in the districtCOUl~t. 4

5. Judge Wesley dissented. Pet. App. 58a-106a.Judge Wesley rejected the majority’s holding thatthere is any international law norm at all, enforcea-ble against either a state or private actor, proscribingclinical trials lacking adequate consent. Pet. App.60a-61a. Judge Wesley explained why such a norm isnot "universal and obligatory":

(1) the International Covenant on Civil andPolitical Rights has been described by theSupreme Court as a "well-known internationalagreement[] that despite [its] moral authority,ha[s] little utility," in defining international obli-gations, Sosa, 542 U.S. at 734, and moreover, itdoes not apply to private actors, such as theDefendant in this action;

(2) the Council of Europe’s Convention onHuman Rights and Biomedicine--a regionalconvention--was not ratified by the most in-fluential nations in the region, such as France,Germany, Italy, the Netherlands and the UnitedKingdom, and it was promulgated ... one yearafter the conduct at issue in this litigation;

(3) the UNESCO Universal Declaration of Bio-ethics and Human Rights of 2005 and (4) theEuropean Parliament Clinical Trial Directive of

4 After the Second Circuit denied Pfizer’s petition for rehear-ing and rehearing en banc, Pfizer filed a motion in the SecondCircuit requesting that the court stay its mandate pending thedisposition of Pfizer’s petition for a writ of certiorari. That motionwas granted July 7, 2009.

82001 both also post-date the relevant time periodby several years;

(5) the Declaration of’ Helsinki issued by theWorld Medical Association, a private entity, and

(6) the International Ethical Guidelines for Re-search Involving Human Subjects promulgatedby the Council for International Organizationsfor Medical Sciences, another private entity, "ex-press[] the sensibilities and the asserted aspira-tions of some countries or organizations" but arenot "statements of un:iversally-recognized legalobligations," Flores [v. ’~ ,~. Peru Copper Corp. 414F.3d 233,] 262 [(2d Cir. 2003)];

(7) states’ domestic laws, which, unsupported byexpress international accords, are not "signifi-cant or relevant for purposes of customaryinternational law," id. at 249; and

(8) the so-called Nuremberg Code, a statement ofprinciples that accompanied a criminal verdict,possesses at best "subsidiary" value as a judicialdecision, Statute of the International Court ofJustice art. 38, June 26, 1945, 59 Stat. 1031, 33U.N.T.S. 993.

Pet. App. 60a-61a (ellipsis and final two bracketsadded).

Judge Wesley went on to conclude that, "evenassuming, for argument’s sake, that internationallaw prohibits states from conducting non-consensualmedical tests," Pet. App. 98a, respondents had failedsufficiently to allege that Pfizer was acting in concertwith Nigeria’s violation of international law. AsJudge Wesley stated, "it is not enough ... for aplaintiff to plead state involvement in some activity of

9the institution alleged to have inflicted injury upon aplaintiff; rather, the plaintiff must allege that thestate was involved with the activity that caused theinjury giving rise to the action." Pet. App. 101a(internal quotation marks omitted; emphasis andellipsis in original). Judge Wesley noted that thecomplaints alleged that the Nigerian governmentprovided general assistance, such as "request[ing] theimport of Trovan and arrang[ing] for Pfizer’s accom-modations and some medical staff in Kano," butexplained that the complained-of "activity was not, asthe majority concludes, conducting the Trovan trialsin general, but rather administering the drug withoutinformed consent"--an activity in which the Nigeriangovernment was nowhere alleged to have knowinglyparticipated. Pet. App. 102a.

Judge Wesley also rejected the panel majority’salternative holding that an ATS claim might bebrought against a private actor, even in the absenceof state action, for engaging in a clinical trial withoutfully informed consent. He explained that, while thelist of actionable international norms remains narrowas against state actors, it is narrower still against"private actors." Pet. App. 84a; see also Pet. App. 93a(quoting Sosa, 542 U.S. at 729).

6. During the pendency of the proceedings below,the Nigerian and Kano State governments them-selves filed civil and criminal actions in Nigeriancourts against Pfizer for conducting the Trovan trialin Kano. See Pet. App. 52a; Nigeria Sues DrugsGiant Pfizer, BBC News Online, June 5, 2007,available at http://news.bbc.co.uk/2/hi/africa/6719141.stm (last accessed July 1, 2009). These actions werepremised on the governments’ view that, far fromknowingly participating with Pfizer in the clinical

10trial, they were themselves harmed by Pfizer’s ac-tions and entitled to recover against Pfizer.

REASONS FOR GRANTING THE WRIT

In the decision below, the Second Circuit announcedfor the first time that a private actor’s clinical trialof a medication abroad, allegedly without obtainingadequate consent in the foreign country, is an inter-national law violation enfi)rceable in a U.S. courtunder the ATS. This decision conflicts with the deci-sions of other circuits both as to the nature of thestate action required to sustain an ATS claim andthe scope of customary international law enforceableunder the ATS against a purely private actor. Certi-orari should be granted to resolve these conflicts andto give much-needed guidance to the lower courtsas to the limited circumstances under which ATSliability is available againe;t American corporationsthat do business abroad.

The ATS, 28 U.S.C. 1350, provides: "The districtcourts shall have original jurisdiction of any civilaction by an alien for a tort only, committed in viola-tion of the law of nations or a treaty of the UnitedStates." This Founding-era statute "was originallyunderstood to be available to enforce a small numberof international norms, ~osa, 542 U.S. at 729,that are "specific, universal., and obligatory," id. at732 (internal quotation marks omitted), such as"violation of safe conducts, iJ~fringement of the rightsof ambassadors, and piracy," id. at 715 (citingBlackstone, 4 Commentaries 68).

In Sosa, this Court instructed the lower courts toexercise "vigilant doorkeeping" to ensure that thisnarrow list is not unduly expanded. 542 U.S. at 729;see id. at 720 ("Congress intended the ATS to furnish

11jurisdiction for a relatively modest set of actionsalleging violations of the law of nations."). The Courtalso urged caution in deciding "whether internationallaw extends the scope of liability for a violation of agiven norm to the perpetrator being sued, if thedefendant is a private actor such as a corporationor individual," as opposed to a state actor to whominternational law norms generally apply. Id. at 732n.20 (emphasis added). As Justice Breyer noted, aninternational law norm enforceable under the ATS"must have a content as definite" and universal as18th-century norms such as the prohibition of piracyand also "must extend liability to the type of per-petrator (e.g., a private actor) the plaintiff seeks tosue." Id. at 760 (Breyer, J., concurring) (emphasisadded).

But in the five years since Sosa, the lower courtshave too often, as here, disregarded this Court’sadmonitions. The ATS has continued to be used tobring complaints for supposed misconduct that, ashere, is a far cry from the settled paradigms Congressrecognized at the Founding. The Second Circuit’sdecision, like its previous decision in the SouthAfrican apartheid case, Khulumani v. Barclay Na-tional Bank Ltd., 504 F.3d 254 (2d Cir. 2007), affdfor lack of quorum sub nom. American Isuzu Motors,Inc. v. Ntsebeza, 128 S. Ct. 2424 (2008), acknowledgesSosa but in fact dramatically expands ATS juris-diction over private American corporations doingbusiness abroad. Recusals prevented the Court fromdeciding on the petition in American Isuzu and thusfrom providing urgently needed guidance on thescope of corporate secondary liability under the ATS.This petition presents a similar opportunity to clarifythe scope of ATS liability as to American corporationsdoing business abroad and to dispel confusion on

questions that have bedeviled the lower courts inSosa’ s aftermath.

Certiorari should be granted, first, because thedecision below conflicts with the decisions of othercircuits as to both interpretation of ATS state actionrequirements and interpretation of Sosa’s limits onthe scope of customary international law norms en-forceable against private actors. Certiorari should begranted, second, because the scope of ATS liabilityagainst private actors for novel customary interna-tional law claims like the one here is a question ofnational and international importance. Where, ashere, American corporations are haled into U.S. courtsto face foreign regulatory or tort claims in the guiseof international law violations, the ATS threatens tobecome an ever more expansive vehicle for burden-some litigation and crippling liability that imposes akind of discriminatory tax on American companiesdoing business abroad.

I. THE SECOND CIRCUIT’S DECISIONEXPANDING ATS JURISDICTION IS INTENSION WITH THIS COURT’S DECI-SION IN SOSA AND CONFLICTS WITHDECISIONS OF OTHER CIRCUITS

This Court should grant certiorari to resolve twocircuit conflicts created by the decision below: (1) aconflict concerning the degree of state action requiredto allow an ATS complaint to proceed, and (2) aconflict concerning what kinds of international lawnorms may be pleaded under the ATS against purelyprivate actors.

The law of nations, as its name suggests, hashistorically required fidelity by nation-states, notby private individuals. There is no general inter-

13national common law of torts. Thus, to establishsubject matter jurisdiction under the ATS for aviolation of international law by a private corporationor individual, plaintiffs in most cases must allegethat the private actor acted under color of law or inconcert with a foreign government.

The Second Circuit’s decision, however, conflictswith decisions of other circuits as to the degree ofstate action required to transform a private partyinto a state actor for ATS purposes. The Fifth, Ninth,and Eleventh Circuits all have rejected ATS com-plaints that were based on purported state action butthat failed to allege that the foreign governmentknew of or participated in the specific conduct allegedto violate international law. The Second Circuit, bycontrast, held below that respondents had sufficientlyalleged state action merely by referring to the Nige-rian government’s general assistance to Pfizer with-out any allegation that the government knew of orparticipated in Pfizer’s alleged failure to obtain ade-quate consent to the clinical trial of Trovan. Thisholding conflicts with the decisions of other circuitsthat have found state action adequately invoked onlyby allegations that the state was specifically involvedin the allegedly wrongful conduct, either as a matterof official state policy or under color of law.

The Second Circuit created an additional circuitconflict by its alternative holding that an ATS claimmay proceed, even without any state action, against aprivate corporation for failure to obtain adequateconsent to a clinical trial. The Sixth, Ninth, Tenth,and Eleventh Circuits all have held that ATSjurisdiction over purely private actors is limited to anexceedingly narrow category of offenses of universalconcern--namely, war crimes, genocide, slave trade,

14and piracy. Those circuits accordingly have requiredATS claims against private actors to be dismissedwhere they allege violation of other internationallaw norms--even norms against such offenses asrape, torture, abduction, detention, pesticide poison-ing, and other alleged crimes against humanity. AsJudge Wesley noted in dissent, the majority’s recog-nition of a "previously unrecognized norm of inter-national law" against nonconsensual clinical trials"apparently overlook[s] the fact that this purportednorm in no way resembles those few norms enforcea-ble against private entities." Pet. App. 92a-93a. ThisCourt should grant certiorari to resolve both conflicts.

A~The Second Circuit’s Decision Con-flicts With Decisions Of Other CircuitsAs To The Degree Of State ActionRequired For An ATS Claim

The Second Circuit’s decision allows respondents toproceed with their ATS claims despite their failure toallege that the Nigerian government knew of orparticipated in the specific conduct by Pfizer that isclaimed to violate international law--namely, theadministration of a clinical trial without adequateconsent. Discussing the requirement of state actionin barely three paragraphs of its opinion, Pet. App.50a-52a, the Second Circuit .allowed the complaints tosurvive based merely on cursory allegations of gen-eral assistance by the Nigerian government. Seesupra at 3-5 & n.2.

No other circuit has so permissively interpreted thedegree of state action required to make out violationsof international law cognizable under the ATS. Tothe contrary, the vague, conclusory, and generalallegations of state assistance allowed by the SecondCircuit here would have led to dismissal under the

15conflicting standards for state action applied underthe ATS in the Fifth, Ninth, and Eleventh Circuits.As Judge Wesley explained in dissent, "it is notenough ... for a plaintiff to plead state involvement insome activity of the institution alleged to haveinflicted injury upon a plaintiff; rather, the plaintiffmust allege that the state was involved with theactivity that caused the injury giving rise to theaction." Pet. App. 101a (internal quotation marksomitted; emphasis and ellipses in original). 5

The Ninth Circuit’s decision in Abagninin v.AMVAC Chemical Corp., 545 F.3d 733 (9th Cir. 2008),starkly illustrates this circuit conflict. In Abagninin,an ATS complaint was brought against a privatecompany that managed an agricultural plantation inthe Ivory Coast, claiming that the company’s use ofa pesticide that caused sterilization of plantationworkers had amounted to a crime against humanityin violation of customary international law. The com-plaint alleged collaboration between the Ivory Coastgovernment and the private company.

The Ninth Circuit, however, found the allegationsin Abagninin insufficient to establish state actionbecause they did not identify any knowing participa-tion by the Ivory Coast government in the specificconduct complained of: the use of the harmful pes-

~ Allowing such conclusory allegations to proceed not onlycreates a circuit conflict with other courts of appeals interpret-ing the state action requirements of the ATS, but also is intension with this Court’s recent decision in Ashcroft v. Iqbal,129 S. Ct. 1937 (2009), which held, extending the holding in BellAtlantic Corp. v. Twombly, 550 U.S. 544 (2007), that a pleadingis insufficient under Fed. R. Cir. P. 8(a)(2) "where the well-pleaded facts do not permit the court to infer more than themere possibility of misconduct." 129 S. Ct. at 1950.

16

ticide. The Ninth Circuit e~:plained that not just "anyinvolvement by the State meets the ’State action’requirement"; rather, "al:[egations of ’affirmativeaction by the government of the Ivory Coast’ fail tostate a claim for crimes against humanity becauseAbagninin does not allege that the use of [thepesticide] was part of a [state] plan or policy tocommit one of the enumerated acts, i.e. to sterilizethe plantation workers." Id. at 742 (emphasis added).Cf. Sosa, 542 U.S. at 737 (noting that the plaintiffthere failed to allege any "’state policy’" favoringprolonged arbitrary detention) (quoting RESTATEMENT

(THIRD) OF FOREIGN RELATIONS LAW § 702 (1986))(emphasis added).

The Eleventh Circuit, like the Ninth Circuit, hasrequired dismissal of ATS claims lacking in specific-ity as to a foreign government’s involvement in thealleged violation of international law. In determiningthe existence of state action under the ATS, theEleventh Circuit "look[s] to ... ’jurisprudence under42 U.S.C. § 1983,’" Aldana v. Del Monte Fresh Pro-duce, N.A., Inc., 416 F.3d 1242, 1247 (11th Cir. 2005)(quoting Kadic v. Karadzic, 70 F.3d 232, 245 (2d Cir.1995)), and thus asks whether a defendant has acted"under color of law. ,6

6 To the extent that the ATS requires a showing of action"under color of law" analogous to that under 42 U.S.C. 1983, theSecond Circuit’s decision is also :in tension with that of manyother circuits interpreting the latl;er statute. For example, theFirst Circuit has held that, "to the extent that state-grantedauthority can justify a finding of state action, that authoritymust be connected to the aim of encouraging or compelling thespecific complained-of conduct." Barrios-Velazquez v. Asociacionde Empleados del Estado Libre Asociado de Puerto Rico,84 F.3d 487, 493 (1st Cir. 1996) (emphasis added). The FifthCircuit has explained that, "[t]o make the requisite showing of

17In Aldana, the Eleventh Circuit affirmed the dis-

missal of all but one ATS claim alleging state actionby Guatemala in connection with militias’ violentdisruption of labor organizing activities at an Ameri-can company’s plant. The court there found thatallegations that Guatemala broadly tolerated privatemilitias and that Guatemalan police failed to stop theviolence were inadequate to support state actionwhere the plaintiffs "d[id] not allege sufficient facts towarrant the inference that the National Police knewof and purposefully turned a blind eye to the events"that were the specific conduct alleged to violate inter-national law. 416 F.3d at 1248.

In Romero v. Drummond Co., 552 F.3d 1303 (11thCir. 2008), the Eleventh Circuit similarly affirmed arejection of claims under the Torture Victim Protec-tion Act, 28 U.S.C. 1350 note ("TVPA"), for failure toprove state action with sufficient specificity. Becausethe TVPA expressly requires a showing of action"under color of law," the Eleventh Circuit, as in ATScases like Aldana, looked to "under color of law"jurisprudence under 42 U.S.C. 1983, see 552 F.3d at1317 (relying on BrentwoodAcademy, 531 U.S. at 295).

state action by a regulated entity, [a plaintiff] must establish ’asufficiently close nexus between the State and the challengedaction of the regulated entity.’" Cornish v. Correctional Servs.Corp., 402 F.3d 545, 550 (5th Cir. 2005) (quoting Blum v.Yaretsky, 457 U.S. 991, 1004 (1982)). And in Crissman v. DoverDowns Entertainment Inc., 289 F.3d 231 (3d Cir. 2002) (enbanc), the Third Circuit explained that the "central purpose" ofthe state action inquiry is to ’"assure that constitutional stan-dards are invoked when it can be said that the State isresponsible for the specific conduct of which the plaintiff com-plains.’" Id. at 239 (quoting Brentwood Academy v. TennesseeSecondary Sch. Athletic Ass’n, 531 U.S. 288, 295 (2001)) (emphasisaltered).

lt~

Applying that standard, the court upheld summaryjudgment against plaintiffs, rejecting their attempt toassert state action where executives of a Colombiansubsidiary of an American coal mining companyallegedly paid paramilitary operatives to torture andassassinate leaders of a Colombian trade union. TheEleventh Circuit held that, to satisfy the requirementof state action, "there must be proof of a symbioticrelationship between a private actor and thegovernment that involves the [misconduct] alleged inthe complaint." 552 F.3d at 1317. Findinginsufficient the complaint’~ allegations of a generalrelationship between the :military and the privateparamilitary actors, id. at 1317-18, the court heldthat "plaintiffs failed to offer evidence either thatstate actors were actively involved in the assassina-tion of the union leaders or that the paramilitaryassassins enjoyed a symbiotic relationship with themilitary for the purpose of those assassinations." Id.at 1318.

The Fifth Circuit approved a similar approach tothat of the Ninth and Eleventh Circuits in affirmingthe dismissal of an ATS complaint in Beanal v.Freeport-McMoRan, Inc., 969 F. Supp. 362, 374-80(E.D. La. 1997), affd, 197 F.3d 161 (5th Cir. 1999), acase emphasized by Judge Wesley in his dissent fromthe panel majority’s state action holding. As JudgeWesley noted, Pet. App. 103a, Beanal held that anATS complaint does not adequately allege state ac-tion unless a governmental actor is alleged to haveactually participated in the wrongdoing at issue.

In sharp contrast to these decisions by other cir-cuits, the Second Circuit allowed plaintiffs’ com-plaints to survive dismissal even though, as JudgeWesley’s dissent noted, they "do not allege that the

19

government or any government employee played anyrole in either administering Trovan without consentor deciding to do so in the first instance," but rather"[a]t most ... alleg[e] that the Nigerian governmentacquiesced to or approved the Trovan program ingeneral without knowing" its details. Pet. App. 102a,105a. The decision below thus conflicts with previousinterpretations of the state action requirement underthe ATS (and TVPA) by other circuits, whether thosecircuits require a showing of official state policy asin the Ninth Circuit’s decision in Abagninin andRestatement (Third) of Foreign Relations Law§ 702, or action under color of law as in the EleventhCircuit’s decisions in Aldana and Romero. This Courtshould grant certiorari in order to resolve this splitand to clarify the appropriate standard for assessingallegations of state action under the ATS.

B. The Second Circuit’s Decision Con-flicts With Decisions Of Other CircuitsAs To The Scope Of CustomaryInternational Law Norms ApplicableTo Purely Private Actors

Certiorari is equally required if the Second Circuitdecision is understood alternatively to expand ATSjurisdiction over purely private actors. This Court’sdecision in Sosa admonishes the lower courts toengage in "vigilant doorkeeping" against improperuses of ATS jurisdiction. 542 U.S. at 729. Sosacautioned that the "federal courts should not recog-nize private claims under federal common law forviolations of any international law norm with lessdefinite content and acceptance among civilizednations than the historical paradigms familiar when§ 1350 was enacted." Id. at 732.

2O

Such "vigilan[ce]" should be all the more heigh-tened when the defendant is a private actor lackingany particularized involvement with foreign stateaction or policy. Because the law of nations typicallybinds nation states, not p~vate actors, ATS jurisdic-tion must be especially sparing when "the perpetratorbeing sued ... is a private actor such as a corporationor individual." Sosa, 542 U.S. at 732 n.20. TheRestatement (Third) of Fc,reign Relations Law, forexample, distinguishes, for purposes of universal juris-diction, between "those violations that are actionablewhen committed by a state and a more limited cate-gory of violations" that are actionable against privateactors. Kadic, 70 F.3d at 240 (citing RESTATEMENT(THIRD) OF FOREIGN RELATIONS LAW §§ 404, 702).The latter category consists,; only of "certain offensesrecognized by the community of nations as of univer-sal concern, such as piracy, slave trade, attacks onor hijacking of aircraft, genocide, war crimes, andperhaps certain acts of terrorism." RESTATEMENT

(THIRD) OF FOREIGN RELATIONS LAW § 404.

The Second Circuit’s decision disregarded Sosa’sadmonitions on both counts. To begin with, it de-parted from all precedent in recognizing a novelprivate right of action under supposed customaryinternational law against conducting a clinical trialwithout fully informed consent. Of the eight sourcesof customary international law relied upon by thepanel majority, seven are patently insufficient toprovide a private cause of’ action under the ATS:Three post-date the 1996 Trovan trial,7 two are pure-

7 The 1997 Council of Europe Convention, the 2001 directiveof the European Parliament and the 2005 UNESCO declarationby definition arise too late to as.sist the plaintiffs here. SeeVietnam Ass’n for Victims of Agent Orange v. DoT Chem. Co.,

21

ly aspirational,8 one is purely domestic,9 and one hasbeen rejected by this Court as unhelpful in the ATScontext.1° The panel thus relied principally on aneighth source, the Nuremberg Code, see Pet. App.79a, but that source too is insufficient.

Numerous federal decisions in other contexts haveheld that "’there is no private right of action for analleged violation of international law for the pro-tection of human research subjects under .o. theNuremberg Code.’" Ammend v. Bioport, 322 F. Supp.2d 848, 872 (W.D. Mich. 2004) (quoting Robertson v.McGee, No. 01-cv-60, 2002 WL 535045, *3 (N.D. Okla.Jan. 28, 2002)). See, e.g., White v. Paulsen, 997 F.Supp. 1380, 1383 (E.D. Wash. 1998) (declining "to

517 F.3d 104, 118 (2d Cir. 2008) (treaty ratified in 1975 couldnot be used to assess conduct in the 1960s); Abagninin, 545 F.3dat 738 ("A treaty not ratified by the United States at the time ofthe alleged events cannot form a basis for an ATS claim.").

s The Declaration of Helsinki and the International Ethical

Guidelines for Research Involving Human Subjects do not con-stitute "statements of universally-recognized legal obligations."Flores, 414 F.3d at 262.

9 The fact that many countries’ domestic laws require in-

formed consent in clinical drug trials does not give those lawsthe status of customary international law. See, e.g., IIT v.Vencap, 519 F.2d 1001, 1015 (2d Cir. 1975) (Friendly, J.) (merefact that every nation’s municipal law may prohibit theft doesnot incorporate the Eighth Commandment "Thou Shalt notsteal" into the law of nations).

~9 This Court has stated that the ICCPR has "little utility" for

ATS purposes, Sosa, 542 U.S. at 734-35, and the courts ofappeals have uniformly held that it "does not provide indepen-dent, privately enforceable rights," Guaylupo-Moya v. Gonzales,423 F.3d 121, 133 (2d Cir. 2005). Accord Padilla-Padilla v.Gonzales, 463 F.3d 972, 979-80 (9th Cir. 2006); Igartua-De LaRosa v. United States, 417 F.3d 145, 150 (1st Cir. 2005) (enbanc).

22imply from the law of nations the existence of aprivate right of action" for alleged violations of theprohibition on nonconsensual medical experimenta-tion). Cf. Conway v. A.I. DuPont Hosp. for Children,No. 04-4862, 2007 WL 560502, at * 7 (E.D. Pa. Feb.14, 2007) (agreeing with "[c]ourts [that] have heldthat there is no private right of action for violationsof these declarations, codes, reports, or regulations,"specifically the Nuremberg Code); Hoover v. W. Va.Dep’t of Health & Human Servs., 984 F. Supp. 978,980 (S.D.W. Va.), affld, 129 F.3d 1259 (4th Cir. 1997)("[T]he Helsinki Accord does not create a privateright of action in U.S. federal courts and [does] nothave the force of law."); Jaffee v. United States, 663F.2d 1226 (3d Cir. 1981) (en banc) (rejecting ananalogy to the Nuremberg Code in denying state-lawand federal due process ci[aims based on the gov-ernment’s testing of the effects of radiation onunknowing soldiers).

The decision below departs from that previouslyunbroken line of precedents by permitting a partyto premise a cause of action on an alleged violationof the Nuremberg Code. The Second Circuit’s boldexpansion of ATS jurisdiction thus disregards thisCourt’s admonition in Sosa that there should be a"high bar to new private causes of action" under theATS, 542 U.S. at 727, and that federal courts "haveno congressional mandate to seek out and define newand debatable violations of the law of nations," id. at728.

Even if the Nuremberg Code (or any of the SecondCircuit’s other asserted sources of customary inter-national law) could give rise to an international lawclaim against a foreign government, however, theSecond Circuit created a clear conflict with other

23circuits in allowing such a novel claim to be assertedagainst a purely private actor. Administering a clini-cal trial without fully informed consent is a mattercustomarily governed by domestic administrative ortort law, and bears no resemblance to the narrowcategory of activities--war crimes, slave trade, pi-racy, or genocide--as to which international lawnorms have been held enforceable against purelyprivate actors.

In conflict with the decision below, other circuitshave repeatedly held that torts outside this narrowcategory are actionable under the ATS only againststate, not purely private actors:

In Cisneros v. Aragon, 485 F.3d 1226 (10th Cir.2007), for example, the Tenth Circuit held that,in the absence of concerted state policy, even thecommission of child rape and other forms of sexualviolation are not international law violations action-able under the ATS against purely private actors. Inso holding, the Tenth Circuit relied upon earlierauthority from the Second Circuit: "A pre-Sosacircuit-court opinion reflected this limitation when itrecognized ATS causes of action for war crimes andgenocide [against private actors] but not ’torture andsummary execution--when not perpetrated in thecourse of genocide or war crimes.’" Id. at 1231 (quot-ing Kadic, 70 F.3d at 243).

Similarly, in Abagninin, the Ninth Circuit heldthat manufacture and use of a deadly agriculturalpesticide on a banana plantation was not actionableunder the ATS absent state action. The court reliedon "It]he traditional conception regarding crimesagainst humanity," which is "that a policy must bepresent and must be that of a State, as was the casein Nazi Germany." 545 F.3d at 741 (citing Prosecutor

24v. Tadic, IT-94-1-T, Judgment, ~[ 654 (May 7, 1997));see also id. ("crimes against humanity are crimescommitted through political organization"). Eventhough the pesticide was alleged to have causedserious injury and death, its administration wasdeemed insufficient to justify an ATS complaintagainst a purely private actor not acting under astate policy.

Likewise, in Aldana, the Eleventh Circuit held thatarbitrary detention, alleged crimes against humanity,and interference with rights of association by privateparties were not actionable under the ATS against aprivate corporate defendant where there was no stateaction. 416 F.3d at 1247:. cf. id. ("State-sponsoredtorture, unlike torture by private actors, likelyviolates international law and is therefore actionableunder the Alien Tort Act.")

And in Taveras v. Taveraz, 477 F.3d 767 (6th Cir.2007), the Sixth Circuit held that even internationalchild abduction and kidnal:,ping were not cognizableas violations of international law under the ATS inthe absence of state action. The court noted that "theATS, by no means, supplies jurisdiction over everywrong committed against ar.L alien." Id. at 771.

The majority below made no mention of these casesand did not try to reconcile them with its alternativeholding. But, as Judge Wesley explained in dissent,the tort alleged here against Pfizer, "medical experi-mentation[,] more closely resembles the acts for whichonly state actors may be held responsible," and even"the norm against torture reaches only state actors."Pet. App. 90a (Wesley, J., dissenting) (emphasisadded) (citing, inter alia, RESTATEMENT (THIRD) OFFOREIGN RELATIONS LAW § 702(d)).

25

Because the Second Circuit’s decision announces anew norm untethered to Sosa’s criteria and disre-gards the crucial ATS distinction between customaryinternational law violations asserted against stateand private actors, certiorari is warranted. If anAmerican corporation’s clinical trial abroad is suffi-cient to give rise to a violation of international lawwarranting ATS jurisdiction, then it is difficult to seeany limiting principle to prevent the ATS from sup-planting domestic remedies and becoming a plenaryinternational law of tort.

II. THE SECOND CIRCUIT’S EXPANSIONOF ATS JURISDICTION OVER AMERI-CAN CORPORATIONS DOING BUSINESSABROAD RAISES ISSUES OF NATIONALAND INTERNATIONAL IMPORTANCE

This Court instructed in Sosa that "the deter-mination whether a norm is sufficiently definite tosupport a[n ATS] cause of action should (and, indeed,inevitably must) involve an element of judgmentabout the practical consequences of making thatcause available to litigants in the federal courts." 542U.S. at 733. The decision below will have significantadverse practical consequences for the conduct ofprivate business abroad and for the Nation’s foreignpolicy and commercial relations. These adverse con-sequences provide additional reasons why certiorarishould be granted.

First, the expansion of corporate ATS liability ex-emplified by the Second Circuit’s decision has thepotential to subject American corporations doingbusiness abroad to burdensome litigation, public rela-tions problems, and crippling liability that will dis-courage their participation in international invest-ment and development. See generally GARY CLYDE

26HUFBAUER & NICHOLAS K. IMITROKOSTAS, AWAKENINGMONSTER: THE ALIEN TORT STATUTE OF 1789, at 37-43 (2003) (calculating the inonetary damage to tradeand foreign direct investment likely to be caused byincreased ATS suits against corporations). Corpora-tions doing business in foreign jurisdictions presentattractive deep pockets and publicity magnets forplaintiffs seeking to bring ATS complaints. Becausethe allegations often turn on events occurring in thefar corners of the developing world, with testimonyand documents all in a foreign language, discovery isparticularly burdensome. Additionally, the negativecorporate publicity that flows from inflammatoryallegations of international law violations enablesplaintiffs to seek coercive settlements.

Such features may explain the noticeable increasein ATS cases against American corporations in thepast decade. As commentators have noted, "In thelatest wave of ATS litigation, foreign plaintiffs havesued corporations--primarily U.S. corporations--inU.S. courts seeking civil :redress for violations ofcustomary international human rights laws in non-U.S. countries." Jack L. Goldsmith & Alan O. Sykes,Lex Loci Delictus & Global Economic Welfare:Spinozzi v. ITT Sheraton Corp., 120 HARV. L. REV.1137, 1146 (2007). Such litigation tends to occurdisproportionately against American corporations be-cause "ATS-style tort suits by private parties to re-cover under customary international law are avail-able only in the United States, and because U.S.personal jurisdiction laws apply much more easily toU.S. than to foreign firms." Id.; see also MelissaA. Waters, Mediating Norms & Identity: The Roleof Transnational Judicial Dialogue In Creating &Enforcing International Law, 93 GEO. L.J. 487, 574n.15 (2005) ("Human rights lawyers have successfully

27utilized the Alien Tort Claims Act to bring a series ofactions against foreign officials and, increasingly,against U.S. and foreign corporations for [alleged]human rights abuses committed abroad."); AttainRosencranz & Richard Campbell, Foreign Environ-mental & Human Rights Suits Against U.S. Corpora-tions In U.S. Courts, 18 STAN. ENVTL. L. J. 145, 148-71 (1999) (analyzing cases in which foreign plaintiffsbrought suit against U.S. corporations in U.S. courtsunder the ATS).

ATS claims against American corporations thuspose a significant risk of vexatiousness, not unlikeactions in other contexts that this Court has soughtto restrain through the use of stringent pleadingstandards and narrow statutory construction. See,e.g., Ashcroft v. Iqbal, 129 S. Ct. 1937; Bell AtlanticCorp. v. Twombly, 550 U.S. 544; Merrill Lynch,Pierce, Fenner & Smith, Inc. v. Dabit, 547 U.S. 71, 86(2006); Dura Pharms., Inc. v. Broudo, 544 U.S. 336,347 (2005). This Court’s review is necessary to pre-vent abuse of the ATS and to provide corporationswith notice of the scope of their potential liability inU.S. courts for their purely private conduct occurringin foreign countries.

Second, the Second Circuit’s decision implicates theforeign relations concerns that this Court identifiedin Sosa. See 542 U.S. at 727 (the federal courtsshould be "particularly wary of impinging on thediscretion of the Legislative and Executive Branchesin managing foreign affairs"). The Second Circuit’suniquely permissive state action standard allowsATS complaints to proceed based upon only thethinnest reed of alleged involvement by a foreigngovernment. Such a lowered pleading standard forstate action makes it easier to attribute bad acts

28

to foreign governments, causing needless offense tosuch governments if a greater number of such alle-gations survive dismissal.11 The decision below thuspresents the very real possibility of "embarrass[iag]the United States in the conduct of its foreign affairs,which is committed by the Constitution to the ex-ecutive and legislative--the political--departments ofthe government." Igartua-De La Rosa, 417 F.3d at151 (quoting Oetjen v. Central Leather Co., 246 U.S.297, 302 (1918)).

Finally, expansive construction of the ATS as inthe decision below injures international commercialrelations by tending to supplant measures for domes-tic redress. By authorizing a radical and unprece-dented expansion of ATS jurisdiction to encompassthe administration of a clinical trial by a U.S. cor-poration in a foreign nation, the decision below com-petes with domestic regulation by Nigeria and othernations through their own administrative and judi-cial systems. Under the decision below, any privatedoctor acting in any hospital in the world, even in theabsence of any state action or policy, could be haledbefore a U.S. district cou.rt for failiag to obtain"informed consent"--a term that is surely subject tovarying definitions among different domestic law re-gimes. Domestic law and remedies, however, canbetter accommodate different nations’ divergent in-terests with respect to the administration of medicaltreatment. And domestic courts are better equippedthan American plaintiffs’ lawyers to assess the rel-

1~ This danger is illustrated here, where the Nigerian gov-

ernment itself has sued Pfizer over the Trovan clinical test,viewing itself as a victim entitled to compensation, at the sametime as the complaints here cast aspersions on Nigeria for itssupposed backing and facilitation of the test. See supra at 9-10.

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ative costs and benefits of clinical trial practices fortheir nations.

These adverse practical consequences raise issuesof national and international importance that pro-vide additional reasons for this Court to review theSecond Circuit’s decision.

CONCLUSION

The petition for agranted.

writ of certiorari should be

Respectfully submitted,

July 8, 2009

KATHLEEN M. SULLIVANCounsel of Record

FAITH E. GAYSANFORD I. WEISBURSTWILLIAM B. ADAMS

QUINN EMANUEL URQUHARTOLIVER 8~ HEDGES, LLP

51 Madison Avenue22nd FloorNew York, NY 10010(212) 849-7000

Counsel for Petitioner