Abdullahi v. Pfizer, Inc.

Attempting step to side the one- additional court proceedings to decide its constraint, the time Trust further merits. year Because Pleasant’s Claim 1015 rectify to argues that there is “cause” was not a “entered without contest” and improper claim that and U.S.C. because the Trust’s motion for reconsider- 502(j)’s authority grant § to consider ation year was not filed within one after motions for reconsideration cause can claim, the allowing order that it was not be restricted the Federal Rules of properly subject to reconsideration under This Bankruptcy argument Procedure. is Rule 9024. § unavailing. 502(j) provides

also While claim that has been allowed or “[a] Conclusion cause,” may disallowed be reconsidered for The judgment of the district court is grant power it does not a to court recon REVERSED. The case is REMANDED any a claim at time. Absent sider with directions enter judgment to contrary, indication to the there is no rea Pleasant to REMAND to the bank- that a pursuant son motion to reconsider ruptcy court for further proceedings con- § 502(j) governed by to should not be the sistent with opinion. Here, limit time set Rule just is not “cause” issue whether exists to mistake but

correct substantive whether procedural mechanism for correcting timely

the mistake was invoked. It was one-year

not. limitation Rule 9024 triggered by the fact that the

was Trust’s predecessor-in-interest objection filed an ABDULLAHI, Rabi individually and as the Appellant’s to claim. Because the guardian personal natural bankruptcy Trust asked the court for re representative estate of her year consideration well over one after the daughter Abdullahi, Lubabatau Sali- entry claim, allowing of the order Abullahi, individually su and as the to motion reconsider that order was unt guardian personal repre- natural imely.6 sentative of the estate of his son sum, it to Salisu, [Manufi] was error conclude that Abulliahi Alasan Abdullahi, individually Pleasant’s claim “entered was without a and as the objected guardian personal contest” when the Debtors had natural repre- claim, though parties even sentative daugh- had of the estate of his Abdullahi, their dispute Hashimu, settled over the claim ter without Firdausi Ali We accept also observe if we were context of another time limitation on chal- the Trust’s hold rationale and lenges claims proceedings, in bankruptcy "Deadlines subject objections filed later settled results, may lead to unwelcome but agreement without court intervention are prompt parties they produce to act and finali- contest,” "entered we without a would create Kronz, ty.” Taylor v. Freeland & 503 U.S. significant parties settling disincentive to 112 S.Ct. 118 L.Ed.2d 280 disputes through except such use of court (1992) (holding bankruptcy trustee could Among impacts, resources. other creditors validity exemption not contest the of an after would have reduced incentives to reach 30-day 4003(b) period provided by Rule agreements regarding disputed with debtors run, despite had fact that the debtor had when claims such settlements could be chal- claiming no exemp- colorable basis for lenged beyond year well later. As the Unit- tion). Supreme ed States Court has stated in the Saleh, Saleh, individual individually natural tar Mukhtar as and by Muhyiddeen Haasan, minor, ly, a representative personal guardian and guardian, Ti father natural daughter his and his Sulei the estate of of Tijjani jjani Hassan, Hassan, individ Inuwa, individu man, Muhammadu Ibrahim, ually, a mi guardian Adamu and Kawu ally as natural and nor, by father natural the estate his and representative of personal Inuwa, guardian, Ibrahim M. Ma Malam Abamus his son Abdullahi of Haruna, Adamu, Alhaji indi individually as Ibrahim Laden, and gaji Alh Idris, individually, vidually, personal guardian and Mallam natural minor, by Idris, father his Yusuf a his representative of estate Umar, guardian, Isyaku, Alhaji Mustapha, Idris and naturall Kabiru son Isa, Umar, individually, individually Hafsat as the natural Idris and minor, by her and natural personal representative a father guardian and Isa, daughter guardian, Asma’u Isa Muhammed Isa the estate of his Isa, individually, Taju Umar, Mustapha, individu Muhammed Suleiman Isa, minor, by her nat ally guardian and a father and and as the natural Usman, guardian, Malam representative the estate ural Isa personal Usman, individually, Ha Suleiman, Zainab Malam Isa son Buhari of his minor, by Abdu, minor, by Isyaku, a her and diza a her father mother Abdullahi, Haja guardian, Isyaki guardian, and Shuai natural natural Shuaibu, individually, bu, Isyaku Haji Abdullahi, individually, Firdausi by Jafaru, minor, by Abdullahi, minor, a her fa her father Zahra’u a Madawaki, guardian, guardian and Jafru natural Abdullahi ther antural and Baba, Madawaki, Baba, individually, indi Jafaru ullahi Abd Abdullahi, minor, by Mohammed, minor, by vidually, a a Anas his Sani guardian, guardian, natural Malam father and natural father and his Mohammed, Abdullahi, Ado, Mohammed, mi in Abdullahi a Malam Sani by dividually, Muhammed, nor, natural mother and Nafisatu a his Ado, minor, by Ado, in guardian, her mother and natural Aisha Aisha dividually, Abdumajid Ali, minor, Muhammed, guardian, Yahawasu a Muhammed, by guardian, individually, his and Yahawasu father natural by Alhaji Ali, Tijjani, minor, fa Nura Muhammad Muhsinu a his Yusuf guardian, Tijjani Ali, minor, by natu and a his father and ther natural Ali, Hassan, Maryam guardian, Alhaji Ali, Mu ral Muhammad Yusuf by Ali, Idris, minor, individually, Ba a her father and hammad Umar damasi, guardian, Idris, Aju minor, a his father natural Malam Adamu, individually guardian, malam Badamasi du natural Ismaila Zubairu, Zubairu, parent guardian and natural Malam Badamasi as Yahaya Ismaica, individually, minor, Mo Muhammadu Fatahu Malam Danladi, hammed, individually parent minor, as his father guardian, Alhaji guardian Mo natural Danladi and natural of Bashir hammed, Ibrahim, Alhaji Ibrahim, minor, Danaldi in Malam Yusab Ya’u dividually, minor, Amale, individually Hamza, parent Dalha and as Suyudi Yu guardian guardian his father and natural and natural minor, Gwammaja, Yu’a, malam Hamza Malam Malasm Haruna sals individually individually, Adamu, parent Gwammaja, Haru and as Tasiu na, minor, by guardian guardian Mukh Mohammed his and natural Haruna, Zangon minor, nor, Adamu, Tasi’u Kwa Audu Ismailia individu jalawa, individually parent ally parent and as and natural guardian guardian Yashaya Samaila, and natural of Nuruddim Ma- minor, Dauda, Ya’y, Dahiru, individually Malam lam Dahauru Musa and individually parent parent, Zango, and as and natu as Malam indi Musa guardian Dahuru, vidually parent ral of Rabi minor and as and natural guardian guardian parent Musa, and and natural minor, as os Samaila Dahuru, minor, Maihula, of Zainab Musa Zan Mallam Alhassan individu gon Marikita, individually ally parent and as and as a and natural parent guardian guardian Najib Maihula, natural and of Is minor, of Musa, minor, Arhaji maila Gama, individually Muiham Mallam Abdullah Soja, individually parent parent mad guardian and as and and as natural guardian personal and Gama, Minor, natural and of Dankuma Dauda representative Nuhu, individually of of parent Estate Hamaza and as Achaji Muhammad, minor, deceased, guardian personal and natural and Achaji Dankwalba, representative Ibrahim individu of of Est. Hamisu ally parent Nuhu, minor, as deceased, and and natural Mallam Ab guardian Representative dullahi, individually Personal parent of as and Ibrahim, minor, guardian Abdullahi personal of Est of and natural and Lawan, individually rеpresentative and Najaratu Mallam as of Est. of parent guardian Adbullahi, minor, deceased, natural and and Malam personal representative Mohammed, individually Est. of Ai of Umaru and Lawan, minor, deceased, Alhaji parent guardian sha as and natural and Sojo, personal representative Tsohon Muhammed individual of Est. of ly parent guard minor, Mohammed, and and deceased, as natural Sule Nasiru, personal representative individually ian and of Mallam and as Muhammed, parent guardian Est. of Alhasi mi Unni and natural and nor, individually personal Zubairui, representative Ismaila of Est. of Nasiru, parent guardian minor, deceased, and as and natural Yusif Yusuf representative personal Musa, individually parent and of Est. and as and Mustapha Zubairu, minor, guardian personal of De natural repre and ceased, individually Musa, Musa, Abubaker sentative of Est. of Nafisatu parent minor, deceased, and Muritala, as and natural of Sa’ada Mallam Minor, Musa, Abdu, individually parent tu Mohamed in and as and natu dividually parent guardian personal represen and and as natural ral and guardian Abdu, minor, of Haruna Muritala, tative of Est. of Umaru Hassan, individually minor, deceased, Tanko, Mallam and as Mallam in parent guardian dividually parent and natural and and as and natural personal representative guardian personal Est. representative of of Sa and diya Hassan, minor, deceased, Tankol, Mal of Est. of madina minor de Umar, individually ceased, lam Sheu, individually Yakubu and Mallam parent guardian of, parent guardian as and natural and as and natural Samaila, individually personal representative Mallam and as and of Est. parent guardian Tankol, minor, deceased, and natural of Ada- of Madina Samalia, minor, Yahaya, Mohamed, mu Musa Malam individual Kabiru individually parent ly parent guard and as and natu and as and natural guardian Musa, personal representative ral of mi ian Ukhasa and minor, personal representative of Est. de and Mohamed, of Kabiru Est. deceased, Abubakar, Maryam Ubah, minor, indi ceased, Mallam Sule parent Jabbo, natural vidually and individu and as Mallam Mohamadu personal representative ally parent natural guardian and and as minor, Abubaker, Mohamadu, Est. Fatima guardian Auwalu individually Idris, deceased, Mallam Adamu, individual Mallam Abdullah guardian parent and natural as guard ly parent and natural representative Est. personal representative personal ian minor, deceased, Mal Idris, of Baba Adamu, minor, Est. of Abdullah individually Bashir, Mohamed lam Plaintiffs-Appellants, parent guardian and natural and as v. representative of Est. personal and PFIZER, Defendant-Appellee. INC., deceased, Bashir, minor, of Sani individually parent Ibrahim, and as 05-4863-cv(L), Docket Nos. personal guardian and and natural 05-6768-cv(C ON). Ibra representative of Est. Hassan deceased, Alhaji him, minor, Appeals, Shuai Court of United States bu, individually parent as and and Second Circuit. personal repre guardian and

natural July Argued: Masjbatu of of Shuai sentative Est. Decided: Jan. minor, deceased, bu, Mallam Abdull Sale, individually parent and as ahi guardian personal and

and natural Shamisiya

representative of Est. of deceased,

Sale, minor, Ibra Mallam individually Amyarawa, and as

him guardian and

parent and natural

personal representative Est. deceased,

Yahaya Ibrahim, minor, Abubaker, individually Abdu

Mallam parent guardian and natural

and as personal representative Est. Abubaker, deceased, minor,

of Nasitu individually Yusuf, and as

Mallam guardian

parent and natural

personal representative Est. of Yusuf, minor, deceased, Mal

Hodiza individually Yusuf,

lam Dauda guardian parent and natural

as

personal representative of Est. deceased, Sheu, minor,

Abubaker Sheu,

Maliam Mohammed individual

ly guard parent and natural personal representative

ian and minor, Mustapha Yakubu,

Est. individually

deceased, Alhaji Ubah, parent guardian

and as and natural

NY, Plaintiffs-Appellants Rabi Abdull- ahi, al. et (Ali Ahmad, Richard Altsсhuler Chever- brief), MD, Alt- on the Altschuler & ly, Haven, schuler, CT, for Plaintiffs- West Adamu, Ajudu et al. Appellants Ismaila (David Klingsberg, Glickstein Steven Herschlein, Veidemanis, D. Maris James brief), Pont, Kaye and Julie B. du on the York, NY, LLP, for Defen- New Scholer Pfizer, danb-Appellee Inc. POOLER, PARKER, B.D.

Before: WESLEY, Judges. Circuit PARKER, D. Circuit BARRINGTON Judge: is from the appeal

This consolidated judgments of United States District the Southern District New Court /.) two (Pauley, dismissing York com- subject jurisdic- for lack of matter plaints Statute, Alien under Tort tion (“ATS”), § in the U.S.C. and alterna- tive, ground on of non conve- forum Plaintiffs-Appellants Rabi Abdull- niens. Nigerian ah! and other children and their Defendant-Appellee Pfiz- guardians sued (“the er, Inc. under the Abdullahi ATS action”). They alleged that Pfizer violated customary pro- a international law norm involuntary hibiting experimenta- an on it experi- tion humans when tested Nigeria, on mental antibiotic children themselves, their including without consent Plaintiffs-Appellants Aju- knowledge. others, chil- du Ismaila Adamu and also of guardians part dren their who were experiment, Nigerian drug Pfizer’s Pfizer, against brought similar action ATS, the Con- alleging violations Act necticut Trade Practices Unfair (Elaine Kusel, (“CUTPA”), Ann and the Connecticut Products S. Peter Safirstein (“CPLA”) (“the Wilmar, Liability ac- Tatiana Act Adamu Lipton, M. Andrew tion”). brief), moved ac- Pfizer to dismiss both Rodriguez, Milberg on the Weiss LLP, York, subject jurisdiction tions for lack of matter Bershad & Schulman New gerian non experiment and on the basis coveniens. doctors with Trovan forum granted court patients The district the motions and children who were Nigeria’s (“IDH”) plaintiffs appealed. both sets of have Infectious Hospital Disease Kano, Nigeria. Working in concert with (1) below, explained As we conclude: Nigerian government officials, the team incorrectly court deter- district allegedly recruited two hundred sick chil- prohibition mined that sought dren who treatment at the IDH against nonconsensual gave half the children Trovan and human medical cannot be Ceftriaxone, the other half FDA-ap- (2) ATS; through enforced proved antibiotic the safety efficacy changed Nigeria circumstances in since Appellants was well-established. filing appeal re-exami- require contend that Pfizer knew that Trovan had forum, appropriate nation of the albeit on previously never been tested on children in legal analysis basis of different from being form used and that animal tests court; that employed the district showed that Trovan had life-threatening (3) incorrectly that the district court ap- effects, side including joint disease, abnor- plied Connecticut’s choice of law rules in mal cartilage growth, damage, liver and a Consequently, the Adamu action. we re- degenerative bone condition. Pfizer pur- verse and remand the to the cases district portedly gave the children who were in the court for further proceedings. Ceftriaxone group control a deliberately low to misrepresent dose order the ef- BACKGROUND fectiveness of Trovan in relation Ceftri- Nigeria A. Trovan weeks, Test in axone. After approximately two Pfizer’s allegedly Pfizer experiment concluded the grant On a district review court’s and left without administering follow-up dismiss, motion to we assume as true the According care. to the appellants, in the alleged complaints, construing facts tests children, caused the deaths of eleven light them in the most favorable to the five of had whom tаken Trovan and six of appellants. See Ass’n Vietnam Vic- for whom had taken the lowered dose Cef- Co., Agent Orange tims v. Dow Chem. triaxone, many blind, deaf, and left others (2d Cir.2008). 104, The cen- paralyzed, brain-damaged. or tral at in events issue these cases took 1996, place in during epidemic Appellants Pfizer, an of bac- that working claim in meningitis terial in Nigeria.1 northern partnership Nigerian with the government, time, The appellants allege that that failed to secure the informed consent of Pfizer, the largest pharmaceutical world’s either the guardians children their corporation, sought gain approval specifically to the to explain failed disclose or the the and Drug experimental study U.S. Food Administration nature of the or the (“FDA”) the use on children of its new serious involved. Although risks the treat- antibiotic, Mesylate, Trovafloxacin protocol required market- ment the researchers to They ed as subjects “Trovan.” contend that offer or read the documents re- 1996, Pfizer, April dispatched questing three of its and facilitating their informed consent, American physicians to work with four Ni- allegedly this was not done in Questions meningitis Frequently Bacterial is a serious and some- cal Disease: Asked surrounding 28, 2008), times fatal infection of the fluids (May http://www.cdc.gov/ spinal the cord and the brain. Centers for meningitis/bacterial/faqs.htm. Prevention, Meningococ- Disease Control and 1998, approved the FDA Trovan for subjects’ native lan- In the English or either patients only. After reports use adult on appellants also con- The of Hausa. guage took Tro- patients failure in who liver its from treat- Pfizer deviated tend that van, eventually in America was its use the children alerting not protocol ment to care. In emergency restricted adult effects of to side guardians or their its European Union banned use. experiment, or other risks Trovan option with the providing them Proceedings B. Below The treatment, in- and not alternative choosing plaintiffs August In the Abdullahi non-governmental them that forming ATS, alleging sued Pfizer under Sans Frontiéres Médecins organization law. experiments violated international Borders) (Doctors providing a was Without the district court September treatment and effective conventional motion to dismiss the Ab- granted Pfizer’s charge, at the free of meningitis, bacterial ground non dullahi claims on the oí forum same site.2 conveniens, conditioned Pfizer’s consent that, allege in an effort appellants The Nigeria. Abdullahi v. litigation Pfiz- Pfizer approval, FDA rapidly secure er, Inc., 8118(WHP), 2002 No. 01 Civ. WL test at its protocol its hastily assembled 2002) (S.D.N.Y. Sept. at *12 Groton, Connect- headquarters (“Abdullahi research ”). Nigeria I It found that was icut, permis- requested received adequate despite alternative forum govern- proceed Nigerian sion to from corruption in plaintiffs’ contentions about time, At Pfizer system. ment in March 1996. Nigerian court *8-10. approval also to have secured from district court denied Pfizer’s motion claimed Fed.R.Civ.P., 12(b)(6), dismiss under Rule Appellants al- an IDH ethics committee. concluding plaintiffs adequately however, lege, ap- the March 1996 alleged that Pfizer’s collusion with the Ni- by Nigerian proval letter was backdated gerian government made it a state actor. government hospi- at the working officials Id. at *5-6. experiments tal after had taken well place and that at the the lettеr was time Meanwhile, group another of children written, no the IDH had eth- purportedly Trovan ex- guardians involved Appellants ics also contend committee.3 periment High sued in the Federal Court experiments were condemned Kano, Nigerian alleging claims under the time of the Kano doctors, including one on Pfizer’s staff at trial. law. That tional, Inc., case, ^[2001] Zango Suit v. Pfizer No. Interna- FHC/ Although appellants allege 2. that to them. Pfizer’s further Pfizer known exacerbate protocol ways might receiving to follow its in that protocol failed called for children Trovan mitigated harm the chil- have the suffered they to switched to Ceftriaxone if did not be They that dren. contend Pfizer violated the Trovan, respond allegedly well did to Pfizer administering orally protocol by Trovan even regular not conduct blood tests the chil- though absorption oral is difficult for sick dren or switch those who suffered from Tro- children; conducting testing prior no to ad- van-related side effects to Ceftriaxone. ministering drug the to determine whether might Nigeria's meningitis strain of be re- Nigerian physician principal 3. A who was the Trovan; failing sponsive to to determine that allegedly investigator the test admitted for meningitis; the children in the test had approval the that his office created backdated experiment failing the to either exclude from when FDA conducted an audit of letter the joint problems test children liver or to experiment the in 1997. problems, though even was for such Trovan (S.D.N.Y.2005). III, in (Nigeria), was In Judge dismissed Abdullahi K/CS/204/2001 voluntarily Pauley held that plaintiffs “[pjlaintiffs 2003 after discontin while correct- following ly from state that exper- ued the suit the removal non-consensual medical judge assigned and, to the imentation bench of the first violates the law nations the therefore, States,” to the judge’s and the second decision laws of the United action jurisdiction personal they identify reasons. failed to decline source interna- Inc., “provide[s] Civ. tional that Pfizer, proper predi- Abdullahi v. No. 01 8118(WHP), jurisdiction at *5 2005 WL cate for under the ATS.” 2005 2005) (“Abdullahi III”). (S.D.N.Y. *9, Aug. Noting WL 14. that “a appeal right Court from the district decision to create a private On of action I, dismissal in Abdullahi the Ab is one left to legislative judgment court’s better in cases,” appellants argued great majority that the dismiss the dullahi he concluded litigation was a cause of Zango al result action for Pfizer’s “[a] failure consent, rampant corruption, get otherwise, indicated informed or Nigerian judicial system pro performing experiments could before on adequate an alternative subject expand vide forum children would custom- ary action. record beyond their Given inconclusive international law far that con- regarding leading (in- dis templated by the events to the Id. at ATS.” *13-14 lawsuit, omitted). Zango missal of the we vacated ternal quotation marks judgment and remanded for further regard With to the non conve- forum fact-finding non forum,' on conveniens. analysis, niens court district declined Inc., Pfizer, Fed.Appx. v. See Abdullahi plaintiffs’ to accept concerning submissions (2d (“Ab Cir.2003) order) (summary alleged bribery Nigerian Pfizer’s offi- ”). II dullahi ground cials on the were not following personal November the dis- knowledge. based on Id. at *16- lawsuit, Zango missal of the a number of Finding that the plaintiffs had failed Zango plaintiffs specific filed the Adamu ac- to submit evidence that the Niger- They alleged planning judiciary tion. ian against would be biased its experiment Trovan Connecticut and in against Pfizer, own citizens an action conducting Nigeria the tests without court alternatively district held that informed,consent, Pfizer Nigeria violated the CUT- was an adequate alternate forum. PA, *16,18. CPLA, Eventually, ATS. Id. at the Adamu was to the action transferred later, months Several the district court New York Southern District of and consol- granted also Pfizer’s motion dismiss the with the Pfizer idated Abdullahi action. Adamu, case. F.Supp.2d Adamu then moved to both fail- dismiss cases for It on its III relied Abdullahi decision to ure to state a claim under the ATS and plaintiffs hold that could not establish non the basis of conveniens. It forum jurisdiction under the ATS. Id. at 501. also moved to dismiss Adamu on the incorporated The district court also ground Connecticut choice of law analysis non conveniens from Ab- forum principles require application Niger- the Nigeria III to find that is an ade- dullahi law, ian which suit bars under CUTPA and quate Applying forum. Id. at 504. the the CPLA. public private interest factors set forth Gilbert, granted 501, The district motions. in Corp. court the Oil v. 330 U.S. Gulf III, 1870811; 508-09, 839, (1947), See Abdullahi 2005 S.Ct. 91 WL 67 L.Ed. 1055 Inc., Pfizer, by grounds Adamu v. 399 495 F.Supp.2d superseded statute on other 172 Cote, 198, Co., Rweyemamu v. F.3d novo. 520 v. Ford Motor

recognized in Cowan (2d Cir.2008). dismissal, (5th “To Cir.1983), court survive 100, the 201 103 grounds plaintiff[s] provide interest factors did must the public found while forum, through interest fac- upon which claim rests support [their] not either ‘to allegations right raise a in favor of dismissal. tual sufficient weighed factors ” Adamu, speculative The level.’ at 505-06. to relief F.Supp.2d. above 399 Fund, Ltd., Commc’ns, v. Shaar the Adamu ATSI Inc. court also dismissed district Cir.2007) (2d 87, claims, Bell (quoting conclud- F.3d 98 plaintiffs’ Connecticut 544, 127 that, Corp. Twombly, choice of law v. Atl. U.S. ing under Connecticut (2007)).6 1955, 1965, governed action was 167 L.Ed.2d 929 5.Ct. principles, by law. at 503. Nigerian barred plaintiffs ap-

The and Adamu I. The Alien Statute Abdullahi Tort then, change has tectonic pealed. Since Statute, The Alien 28 U.S.C. Tort political landscape. the relevant altered 1350, provides § district courts “[t]he 2007, brought state of Kano May original jurisdiction have civil shall against and civil claims charges criminal tort only, action for a commit alien Pfizer, damages in seeking over billion $2 of the law of nations or ted violation time, Around the same and restitution.4 treaty of States.” Included United Nigeria sued government the federal Judiciary pro Act of the statute employees, of its seek- Pfizer several jurisdiction just during two cases vided of these ing damages.5 billion in None $7 first 191 after enactment. years its subjects compensation seek for the cases Taveraz, See Taveras v. F.3d tests, the appellants who are before (6th Cir.2007). thirty years, In the last this Court. Pfizer then notified this Court however, slightly the ATS has functioned light developments, that in of these recent jurisdiction robustly, conferring over more required it further consid- which believed category a limited of claims. court, it not eration the district would affirmance on the basis of non seek extensively first ATS We examined the forum conveniens. Pena-Irala, Filartiga F.2d 876 v. (2d Cir.1980), held where we that conduct

DISCUSSION nations violating law of is actionable “only actions where nations of The district court dismissed both under ATS that it lacked the world demonstrated that based its determination have mutual, merely not subject jurisdiction plain- wrong matter is of sever because concern, al, interna express tiffs failed to claims under the ATS. means state Following at ground review dismissal on this de tional accords.” Id. 888. We Akannam, Nigeria: http://business.timesonline.co.uk/tol/business/ 4. Tina Ad- Pfizer—Case 1990908.ece; industry_sectors/health/article journed May Vanguard, April Till News, Pfizer, http://allafrica.com/stories/2008 Nigeria Drugs Sues Giant BBC 5, 2007, 04300470.html; Stephens, http://news.bbc.co.Uk/2/hi/ Joe Faces June Pfizer Nigeria, Washington Charges Criminal africa/6719141.stm. Post, A10, May http:// available www.washingtonpost.com/wp-dyn/contenl/ Twombly "plausibility instituted flexible standard,” cases, article/2007/05/29/AR2007052902107.html. to antitrust limited requires amplification of facts in Iqbal Hasty, v. Clayton, certain contexts. Jonathan Under Fire Pfizer After TimesOnline, 2007, 143, Cir.2007). Trial, 27, (2d Drug 155-58 June that claims and Filartiga, we concluded ATS of nations” with “the understanding brought may against private sometimes be that common provide law would actors, officials, only and not state see 720, action.” cause of Id. at 723. The (2d Karadzic, v. Kadic Supreme Court confirmed that federal Cir.1995), vio when the tortious activities retain a power courts limited to “adapt[] norms of “universal that are late concern” of the law nations private rights” by to recognized to the of to extend conduct “a recognizing narrow class internation- slavery, ge private parties example, —for al to judicially norms” be enforceable nocide, crimes, and war id. at 240. This our through residual common law discre- allegations case involves of both and state tion to create causes of action. Id. at 728- In individual action. Flores v. Southern cautioned, however, It that courts (2d Copper Peru Cir. Corp., power must exercise this with restraint 2003), we that “the clarified law of nations” and “the understanding that the door [to body in the “refers ATS context to the ajar subject actionable violations] is still to customary law known as international vigilant doorkeeping,” permitting only law,” myriad which “is from de discerned that those claims “rest on a norm of inter- made in numerous and inter cisions varied national character accepted the civilized national and domestic arenas” and “does world and defined with specificity compa- any single, definitive, not stem from readi rable to the features of the 18th-century ly-identifiable source.” Id. at 247-48. paradigms Supreme [the recog- has] Court principles rejected These are en their nized.” Id. at 729. These 18th-centu- tirety by dissenting our In colleague. ry paradigms against consist of offenses Flores, jurisdiction we concluded ATS ambassadors, the right violations of to safe alleged is limited to violations of “those passage, and individual arising actions out unambiguous clear rules piracy. Id. at 724. The common theme abide, universally they or to which States among these offenses is that contra- accede, legal obligation out of a sense nations, vened the law of admitted of a Apply mutual Id. at concern.” judicial remedy, simultaneously ing standard, appel we held that the consequences threatened serious in inter- mining op lants’ claim that from pollution national affairs. Id. at 715. Lower courts lung erations caused disease state failed to are required gauge brought claims un- a violation of law. international against der the ATS current “right reasoned that the state of We to life” law, “right insufficiently were but permitted health” are to rec- binding customary definite to constitute ognize under federal only common law legal norms and that there was insufficient those claims for violations of cus- evidence to establish existence of a tomary international law norms that re- narrower norm prohibiting intranational degree flect the same “definite content pollution. Id. at 254-55. acceptance among civilized nations” as 18th-century those reflected para- Court Supreme comprehen- digms. Id. at Supreme 732-33. The sively addressed the ATS for the time first Court in Sosa also Alvarez-Machain, counseled “the in Sosa v. 542 U.S. (2004). determination whether a norm is suffi- 124 S.Ct. 159 L.Ed.2d 718 ciently support cause of Souter, definite action writing majority, Justice (and, must) indeed, inevitably should was cre- in- clarified the ATS enacted to jurisdiction “a volve an element of about relatively judgment ate over modest alleging practical consequences making set actions violations of the 174 collaborated corporations purportedly to in federal litigants” available

cause Africa government of South with Id. courts. maintaining apartheid because aided to way “high a bar Sosa set In this customary inter violations of and abetted alleging of action” vio causes new law. Id. In Vietnam national at 260. Id. customary law. international lations of Orange Agent v. Dow Victims of Ass’n for one recognize can A federal court at 727. (2d Co., Cir.2008), 517 F.3d 104 Chemical of identifies the violation only plaintiff if a support did not we concluded the ATS law international customary of a norm that the violated inter a claim defendants of such law that, by the sources as defined supply manufacturing national law long, “have al courts that United States Agent Orange and other herbicides ing at 733-34 cautiously, recognized,” id. beit military during the United used States Habana, 175 (referencing The Paquete rea War. at 123. We the Vietnam Id. 677, 700, 44 L.Ed. 320 20 S.Ct. U.S. that the of law on which the soned sources universal, (1900)), sufficiently specific, is relied not define a norm appellants did es to meet the standards obligatory Agent of prohibiting wartime use Sosa, at by Sosa. See 542 U.S. tablished and suffi Orange was both universal approval (citing with S.Ct. ciently satisfy requirements to specific Libyan Republic, 726 v. Arab Tel-Oren Similarly, of Sosa. Id. 119-23. Mora (D.C.Cir.1984) (Edwards, J., York, People v. the State New of of Marcos, In concurring), and re Estate of (2d Cir.2008), F.3d 183 we held Litig., Rights Human the de prohibits norm at issue—one that Cir.1994)). (9th Applying principles, these foreign of a national without in tention plaintiff, Court that the Supreme held him of the forming requirement consu a fellow Mex a Mexican national who sued lar notification and access under Article allegedly national under the ATS for ican 36(1)(b)(3) of the on Vienna Convention illegal by agents aiding his abduction insufficiently uni Consular Relations —was Drug Agency, had the U.S. ‍​​‌‌‌‌​​​‌​‌​​‌​​‌​​‌‌​​​‌​‌‌​​​‌​​​​‌‌‌​​‌​‌​​‌‍Enforcement support to a versal claim under ATS. allege customary a failed to violation of at 208-09. required law norm international with Sosa, 738, 124 and remain- Turning appeal, S.Ct. now this precision. U.S. Supreme obligation proceed that the mindful of our ing Court found area, a consequences recognizing cautiously self-consciously this practical alleged norm general and broad we determine whether the (1) in a prohibition arbitrary detention is a norm of international character involving by, “a single illegal universally case detention that States abide accede (2) to, day, transfer of a legal obligation; less than followed out of sense of is custody prompt specificity comparable to lawful authorities and defined 18th-century arraignment” “breathtaking” paradigms would bе discussed in (3) Sosa; Id. at 124 S.Ct. mutual concern to inappropriate. States. Sosa, has reviewed Since Court A The Prohibition Nonconsensual judgments dismissing claims under three Hu- Experimentation Medical Barclay v. Na the ATS. Khulumani mans Ltd., (2d Bank, tional 504 F.3d 254 Cir. 2007) curiam), Appellants’ prem that the ATS claims are (per we held ATS custom- jurisdiction multinational on the existence of a norm of conferred over ised (1) prohibiting non-consenting subjects: law medical on human ary international non-consenting Code, human which experimentation Nuremberg states as its first pro- subjects. To determine whether that principle voluntary “[t]he of consent accepted a universally constitutes subject essential”; hibition the human is absolutely law, customary international we (2) norm of Medical the World Association’s Decla- the current international examine state of Helsinki, ration of which sets forth ethical consulting by sources identified guide principles physicians world-wide Interna- Article 38 of the Statute of the that provides subjects and human should (“ICJ Statute”), of Justice tional Court grant be volunteers their informed the United States and all members which (3) research; participate consent to Flores, are parties. of the Nations United guidelines authored for In- Council 250; see, at States v. e.g., United Organizations ternational of Medical Ser- (2d Cir.2003). 56, Yousef, 327 F.3d 100-01 (“CIOMS”), vices which require “the vol- 38 identifies the Article authorities untary informed consent of prospective [a] “competent proof of content of provide (4) subject”; and Article 7 of Interna- Flores, customary international law.” 414 tional Covenant on Civil and Political 251. These consist of: F.3d at sources (“ICCPR”), Rights provides that “no (a) conventions, subjected international whether one shall be without his free particular, establishing general rules consent to medical or experimen- scientific recognized by contesting expressly tation.” states; court The district found that “non-con- (b) custom, international of as evidence sensual medical violates law; practice accepted a general as and, therefore, the law of nations the laws (c) general principles recog- of law of the United States” and cited the Nu- nations; civilized nized III, for remberg support. Code Abdullahi (d) judicial ... decisions the teach- 1870811,at 2005 WL *9. It then noted ings highly publi- the most qualified of authority federal courts have “[w]hile nations, subsidiary cists of various the existence of a imply private right of for the rules means determination of of jus cogens action for violations of norms law. law, international federal courts con- must of the International Statute Court Jus- sider whether there exist special factors tice, 38(1), 26,1945, 1055, June art. 59 Stat. counseling hesitation of af- absence 1060, No. T.S. ICJ Stat- [hereinafter (inter- by Congress.” firmative action Id. ute]. omitted). quotation nal citations marks appellants ground analyzed their claims The district court then separately four sources international law cate- the four sources law that gorically prohibit forbid medical experimentation nonconsensual medical experimen- (1) respectively policy/pdPFed. Appx.c.pdf sources are located [hereinafter These Declaration of Brandt, Helsinki]; (3) United States v. 2 Trials War Crimi Council Or International [CIOMS], Nuremberg Military ganizations nals Before Tribunals of Medical Services In 10, Under Control Council Law Ethical No. ternational Guidelines for Biomedical Trials]; (2) (1949) Nuremberg Involving Subjects, guide [hereinafter Research Human Ass'n, (3rd ed.2002), superseding guide Med. World Declaration Helsinki: line 4 id. (2nd ed.1993); (4) Principles Ethical Medical Research In line 1 Cove International 20, 22, 7, volving Subjects, Rights, Human art. G.A. Res. nant on and Political Dec. Civil art. (adopted amended 999 U.N.T.S. 171 [hereinafter 2000), ICCPR], http://www.wma.net/e/ that norms of engage the fact court did not Decla- the Universal humans

tation on “discerned international law are at *11-13. Rights. Human ration in numerous made myriad from decisions exception with the It found are- and domestic and varied international contain Code, sources these Nuremberg single, from and not stem “[do] lack- nas” language vague or only aspirational definitive, readily-identifiable source.” jurisdiction. required specificity ing the Flores, 414 F.3d at 247-48. also determined *12-13. It Id. at ratify or did not States the United because inappropri court also The district except the authorities any of these adopt respects. in two ately inquiry narrowed its is ICCPR, even ICCPR and because on First, consideration it focused its of them create self-executing, none plain the norm identified whether legal obligations binding international to which set forth conventions tiffs is Id. at in federal court. are enforceable so, if party, is a and States United conclud- Finally, the district court *11-13. self-executing are these treaties whether a provide failed to plaintiffs ed that legislation. While by federal or executed jurisdiction be- for ATS predicate proper treaty or the self-executing a adoption of independently of the sources cause none self-exe treaty a that is not execution of cause of action a authorizes of a the best evidence cuting may provide a a cause of action is of such the inference country’s practice custom or particular at *13- Congress. best left matter norm, Flores, 414 F.3d at a see recognizing 14.8 customary of a norm of the existence determined, miscon- one approach court’s law is The district prac or customary inter- reference to the custom part, the nature of both strued States, accep the broad inquiry many scope tices of law and national by the international of that norm mistakenly It assumed tance by Sosa. required that are not self- community. Agreements particular question of whether that the not been executed executing or have norm is suffi- customary international law including the legislation, universal, federal obligatory ciently specific, ICCPR, considered evi appropriately are of action recognition of cause permit the of the current state essentially by dence ATS is resolved under the Khulumani, 504 law. See each international things: at two whether looking (Katzmann, J., concurring) is referencing the norm bind- source of law treaty that em (noting that expressly “[w]hether whether each source ing and customary international norm of [a enforce the bodies a cause of action to authorizes to, is seen, self-executing is relevant but Sosa, is law] have re- But as we norm. of, question” inqui- [the] not determinative and nuanced a more fulsome quires jurisdic permits the norm ATS how whether obligated are to examine ry. Courts tion). moreover, is not treaty, A formal compares of the nоrm specificity customary in source of primary the lone 18th-century whether the norm paradigms, permits, law. The ICJ Statute community, and ternational in the world accepted is among things, other encourages, universally by the and Sosa abide whether States custom, “international that courts consider of mutual concern. out of a sense norm accepted general practice of a district as evidence eschewing inquiry, By claim, an ATS plaintiffs' failure to state interchangeably refers to 8. The district court identify per- a norm that subject their failure to jurisdiction” or "lack of the "lack of claims, action. of a cause of plaintiffs' mits the inference jurisdiction” over matter Statute, 38(1); supra, at art. States universally as law.” ICJ subscribe. See Sosa, Sosa, 2739; 542 U.S. S.Ct. 542 U.S. at 124 S.Ct. (“[WJhere treaty, is no no con- there Vietnam Ass’n Agent Victims judi- legislative or trolling Orange, prohibition executive act F.3d at 117. The decision, cial resort to the must be had on nonconsensual medical experimentation nations.”) usages beings of civilized customs and human meets this standard be- Habana, cause, (quoting Paquete among reasons, U.S. at it specific, other 290). 700, 20 accepted by S.Ct. focused and nations around significant the world without exception. Second, the district court’s consideration source of whether each law creates prohibition The evolution of the into a binding legal norms failed to credit the customary norm of began international law fact that even declarations of international with the war crimes Nuremberg. trials at not in norms that are and of States, themselves Union, The United the Soviet binding may, conjunction time and in Kingdom “acting United and France provide that a practice, with state evidence Nations,” all interest of the United estab- developed univer- specificity, norm has Military lished the International Tribunal obligatory sality, required (“IMT”) and nature through entry into the London jurisdiction. See Filartiga, 8, ATS Agreement August M. Cheriff (“[A non-binding] Declaration cre- al., et Appraisal Bassiouni An Human adherence, an and inso- expectation ates Experimentation in International Law far expectation gradually justified as the The and Practice: Need International may by practice, State declaration Regulation Human Experimentation, recognized laying custom become as down 1597, L. & Criminology J.Crim. 1640 & States.”) (internal (internal binding upon (1981) rules n. 220 quotation marks omitted). quotation omitted). marks district The Agree- Annexed to the London greater court should have considered a Charter, ment was London which differently and range weighed of evidence served as the IMT’s Constitution. See probative value the sources on Agreement for the Prosecution and Pun- relied. appellants Major ishment of the War Criminals of the Powers, Axis European with annexed sum, inappropriate it was for the Military Charter of the International Tri- forego district court to a more extensive Aug. bunal art. 59 Stat. treaties, examination of whether interna- Charter, 279. According U.N.T.S. to the agreements, practice tional have State “power try had the punish IMT to and ripened prohibition of nonconsensual who, persons acting in the interests of the sub- human countries, European Axis whether as indi- jects customary into a international law organizations, viduals or members of (i) sufficiently norm that is and universal committed,” offenses, among other war (ii) definable, obligatory, specific and and against humanity. crimes and crimes (iii) concern, of mutual permit courts at art. 6. infer a of action under ATS. See cause Sosa, 732-35, 542 U.S. 124 S.Ct. 2739. “major” tried 22 The IMT Nazi war proceed now with such an We examination. leaving war criminals “lower-level” crimi- nals, including “[l]eading ... physicians Universality i. industrialists,” leading German to be appellants The must allege subsequent military the violation tried in trials U.S. of a norm acting aegis law “under the tribunals ... se- tary single trials form a tribunal] Holocaust Memorial IMT.” United States Trials, Museum, quence principles”), Holocaust on common War Crimes based (2008), http://www.ushmm. Encylopedia Control Law No. 10 served Council org/wlc/article.php?lang=en&ModuleId= implement the commitments undertaken that authorized the (noting 10005140. The Agreement, see id. at 7 London tribunals, military creation of the U.S. supplemented two documents “the No. was enacted Council Law Control “[m]ajor criminals not each other” Council, see by the Allied Control in 1945 tried could under under the one be tried id., through which the Lon- authority other”). joint- exerted Agreement signatories don In August Military Tribunal Germany, Encyclopedia over see control judges prosecu- American staffed Britannica, Encyclopedia Bri- Germany, pro- under tors conducted American (2009), http://search.eb.com/ Online tannica rules, Annas, George cedural see J. No. Council Law Control eb/article-58214. Nuremberg in U.S. Ethics Code Courts: purpose “give was to 10 stated its Expediency, versus in The Nazi Doctors ... to the terms of London effect 201, Nuremberg Code Agreement [London] ... and Char- (George Annas & Michael A. Grodin J. ter,” a uniform ba- legal and “to establish eds., 1992), Nuremberg promulgated the Germany prosecution for the of war sis judg- final part Code as of tribunal’s 10, Council No. criminals.” Allied Control ment fifteen were against doctors who (Dec. 20, 1945), http://avalon. preamble, found crimes guilty of war crimes and Law 10 ex- Iaw.yale.edu/imt/imtl0.asp. No. against humanity conducting incorporated Agree- the London pressly consent, experiments the subjects’ without ment, “integral part[ identifying ] it as Brandt, Trials, Nuremberg at 181-82. Law.” at art. I. No. 10 of this Id. Law Among experiments the nonconsensual military also authorized tribunals of that cited as for their the tribunal a basis occupying powers prosecute individuals drugs testing convictions were of IMT for the same crimes over malaria, against epidemic immunization jurisdiction, including had war crimes and jaundice, smallpox cholera. typhus, id. against humanity, crimes see at arts. Id. at 175-178. Seven of the convicted III, military prose- and made tribunal II— doctors were sentenced to death and subject right first cutions to the IMT’s of vary- remaining eight were sentenced to refusal, Consequently, see id. at art. III. ing imprisonment. terms of Id. at 298- effectively military oper- the U.S. tribunals emphasized 300. The tribunal IMT, ated as of the Telford extensions see every single appearing [i]n instance Taylor, Report Secretary Final to the record, subjects who did were used Army on War Nuernberg Crimes indeed, experiments; not to the consent Trials Under Council Law No. Control experiments, it as some of the is (1949) 107, 107 Report on [hereinafter even contended the defendants Trials],

Nuernberg War Crimes available vol- subjects occupied the status of http://www.loc.gov/rr/frd/Military_Law/ unteers. pdf/NT_final-report.pdf (explaining that judgment Id. concluded “the trials under Law No. 10 were to be a experiments under “[manifestly human means of such carrying out 'declarations princi- criminality’ contrary such conditions are to the ... the International Mili- as they result tary ples Tribunal make” and the law nations as might that “[t]he civilized following usages among first trial and the 12 from established [IMT] [mili- humanity, from peoples, the laws of and tors of the universal and fundamental public recognized from the dictates of conscience.” norms jus cogens,” from (emphasis quotation added and internal which no derogation permitted, is irrespec- omitted). part marks The Code created as practice tive the consent or a given judgment of the tribunal’s therefore em- State. Siderman de v. Republic Blake (9th principle Cir.1992) (cit- as its first phasized Arg., “[t]he 965 F.2d subject human voluntary F.R.G., consent of the is ed in Sampson v. (7th Cir.2001)).

absolutely essential.” Id. at 181. Taylor, As Telford who first served as an assistant to Justice The American tribunal’s conclusion that Robert during Jackson his time as Chief action that contravened the Code’s first Prosecutor for the IMT and then became principle against constituted a crime hu- Chief of Counsel for War Crimes on the manity is a lucid indication of the interna- Nuremberg trials held under the authority legal significance prohibition tional of Control Council Law No. explained, experimentation. on nonconsensual medical “Nuernberg was based on enduring [legal] Supreme As Justices of the Court have principles and not temporary political recognized, “[t]he medical trials at Nurem- expedients, and this fundamental point is berg deeply in 1947 impressed upon the apparent from the reaffirmation of the that experimentation world with unknow- Nuernberg principles in Control Council ing subjects morally human legally Law No. application their unacceptable.” v. Stanley, United States in the 12 judgments rendered 483 U.S. S.Ct. 97 refinement under that during law 3-year period, (1987) (Brennan, J., L.Ed.2d 550 concur- 1947 to Taylor, Report 1949.” on Nuern- (em- in ring part dissenting part) in Trials, berg Crimes (emphasis War at 107 added); phasis 709-10, see also id. added). (O’Connor, J., concurring S.Ct. 3054 in part dissenting in part). view, Consistent with this the Code’s

Moreover, both the legal principles ar- first principle has endured: “[Significant ticulated in the authorizing trials’ docu- opinion world has not come to the defense ments and their in application judgments of the nature or in manner which the Nuremberg occupy position special experiments were conducted the Nazi importance in the development of bedrock camps.” al., concentration Bassiouni et norms of international law. supra, Rather, United States at 1641. since Nuremberg, examining Nuremberg courts judg- throughout states the world have shown “[tjhe recognized ments have that through univer- international accords and domes- rights sal and fundamental law-making human be- tic pro- consider the ings identified Nuremberg rights hibition on experi- nonconsensual medical — enslavement, against genocide, and other mentation identified at Nuremberg as a inhumane acts ...— are the direct ances- norm of customary international law.9 Convention, Fourth Geneva which en- Convention Relative to the Protection of Civil- 32, provides 12, tered into force in protec- 1950 and Aug. ian Persons in Time of War art. war, 1949, tion to civilians in the time of elaborates 6 U.S.T. 75 U.N.T.S. 287. Ac- application during cording on the of the norm commentary, "[protectеd per- armed to the prohib- conflict. Article 32 of the convention sons must not in circumstances be used military agents par- 'guinea its civilian or of the pigs’ experiments.” state as for medical conducting ties from "medical or scientific Commentary on the Geneva Conventions 12of experiments not necessitated the medical August 1949: TV Geneva Convention Relative protected person.” treatment of the Geneva Protection Civilian Persons in Time conceive Its status as a norm states International Cove draft binding part therefore legally add as was revised to Rights

nants on Human —and law—is confirmed customary international tor prohibition to its sentence second accord, requires 2 of the by Article degrading cruel, inhuman or ture and ... Party undertake[ ] State “[e]ach The addition punishment. or treatment to all individuals respect and to ensure particular, no one shall provided “[i]n territory subject juris- to its within its consent to his free subjected without be recognized present in the rights diction the in medical or scientific 2(1). art. The inter- ICCPR Covenant.” risk, required by not such is volving where community’s in the recognition national mental health.” physical his state of protect humans obligation of its ICCPR Inter text of the draft Annotations on the experimen- against nonconsensual medical Rights, at on Human Covenants national tation, regardless of the source of the ac- Sess., Annexes, GAOR, 10th U.N. tion, prohibi- evidence of the powerful is 28(11), (July Doc. item U.N. agenda A/2929 place tion’s international law. 1955). later revised to The clause was sweeping prohibition simpler offer the that, the court mentioned It is clear as subjected without his that “no one shall be Sosa, Hu- Declaration of Universal experi or scientific free consent to medical and the themselves Rights man ICCPR ICCPR, at art. 7. This supra, mentation.” relevant, applicable could not establish Article 7 of the part of prohibition became in that rule of international case. ICCPR, into force which entered Sosa, 754, 124 542 U.S. at S.Ct. 2739. than 160 binding on the more legally and is Nonetheless, ICCPR, when viewed as ratified the con that have States-Parties the norm articulated a reaffirmation of provis to the vention without reservation Code, Nuremberg potent is authori- By prohibition terms this ion.10 its ty acceptance pro- for the universal actors; rather, guaran it limited to state experi- hibition on nonconsensual right below, to be free from tees individuals mentation. As we discuss see infra experimentation by 181-83, prohibition nonconsensual medical fact that the on pp. actors, actors, private or humans any entity on with- — state consciously in con embed- behaving state and actors out consent has been and reaffirmed Congress ded our law cert. eds., (Oscar http://www.icrc.org/ihl.nsl7WebSign2Read & Henri Coursier War 224 Uhler 1958). commentary explains that the This ps=P. Form & id=375 & prohibition directly prin- is related to first Nuremberg pro- ciple "[i]n of the Code since 10. Although certain States-Parties to the experiments protected hibiting medical on ICCPR have made reservations or declara persons, Diplomatic Conference wished respect prohibition of tions with to Article 7's practices ever the criminal from abolish for cruel, degrading or torture and inhuman persons thousands of suffered in the which punishment, we are not aware of treatment camps war.” The [second] death world State-Party any qualification by a similar practices experi- involved human medical experi prohibition of medical or scientific objectionable ments that were because the free of human mentation without consent Brandt, 2 were nonconsensual. See Nurem- subjects. See Office of the United Nations Trials, berg legally- at 183. The convention is Rights, High for Human Inter Commissioner binding on that have ratified it 194 states Covenant on Civil and Political national without reservation to Article 32. See Inter- Reservations, http:// Rights, Declarations and Cross, Geneva national Committee of the Red Parties, www2.ohchr.org/englisb/bodies/ratification/ August Conventions of 12 1949 State Declarations, ReservationsICCPR.pdf. Signatories, Reservations and docs/Declarations subject’s the FDA dem- “obtain the freely-given numerous occasions searchers govern- consent, that the United States preferably onstrates informed in writing.” the norm as the source of a ment views Id. at art. 22. obligation though even binding legal Although the Declaration itself is non- not ratified the United States has ICCPR 1960s, since it binding, spurred has in full.11 regulate experimentation, States to human the World Medical Association by incorporating often its informed con- Helsinki, adopted the Declaration of requirement sent into domestic laws or obtaining enunciated standards in- regulations. Delon Human See & Sev S. subjects. from human It formed consent Fluss, The World Medical Association’s provided that clinical research combined Declaration of Helsinki: Historical care, possible, at all professional “[i]f Contemporary Perspectives, (July 8-11 patient psychology, consistent with 2001) (fifth draft), http://www.wma.neUe/ patient’s freely doctor should obtain the ethicsuniUpdf/draft_historical_ contempo- given patient consent after the has been rary_perspectives.pdf (describing legal a full and that given explanation,” non- regulatory developments Australia, person clinical research on a therapeutic Brazil, China, Belgium, Israel, Japan, “cannot be undertaken without his free Zealand, Switzerland, Norway, New consent, fully after has been informed.” he following the United States the Declara- Ass’n, Med. Declaration Helsin- World Helsinki). Currently, tion of the laws and ki: Ethics the World Medical Code of regulations eighty-four least coun-

Association, III(3a), (1964), art. G.A. Res. tries, States, including the require United http://www.pubmedcentral.nih.gov/ subjects the informed consent of human picrender.fcgi?artid= 1816102 & blob- medical research.12 That this conduct has type =pdf. The Declaration has since subject been the legislation domestic been amended five times. The informed not, course, proof and of itself of a provision provides consent now “sub- Flores, norm. See 249. How- jects and informed par- must be volunteers ever, incorporation of this norm into ticipants project.” in the research Declara- country the laws of this and this host of Helsinki, supra, tion of at art. 20. The a powerful others is indication of the in- requires Declaration also “[i]n acceptance ternational of this norm as a beings, potential research on human each where, here, subject binding legal obligation, adequately must be informed of aims, methods, ... states have anticipated benefits shown the norm is of potential study, by including variety risks of the and the mutual concern it in a may it entail” discomfort re- of international accords. Department

11. Khulumani makes clear that treaties that 12. The of Health and Human laws, signed compiled regulations, the United States neither nor rati- has Services has guidelines governing subjects alone ICCPR that fied—let treaties like the human re- signed eighty-four United States but has not ratified— search in countries. See Office of Prot., may Dep’t evidence a Human Research of Health & Servs., purposes treaty Compilation norm for ATS where has Human International of (2008), widely Subject been ratified and it is clear that the Protections Human Research http://www.hhs.gov/ohrp/international/ reason for United States’s failure to sub- treaty par- HSPCompilation.pdf. scribe to the unrelated to the It was is uncontested that all Khulumani, question. compilation ticular norm in See of the countries identified in this J., (Katzmann, require experi- 504 F.3d at 276 n. 9 informed consent to medical concurring). mentation. 182 throughout the world. United norm the norm United States history of

The that, firmly requires predicate as a that it has been States law law demonstrates drug, both years approval than 45 and-— FDA of new for more embedded colleague foreign sponsors drug va- dissenting American and except for our —its trials, seriously questioned involving clinical whether lidity never been research has abroad, Congress patient- mandated in- by any procure court. conducted here or in 1962. drug subjects. research subject consent formed consent from human al., (citing 21 312.20, (2008); at 1624 supra, §§ Bassiouni et see also C.F.R. 312.120 (1976)). 355(i) response, Servs., § U.S.C. Human Dep’t of Health & Office regulations re- FDA its first promulgated Gen., Inspector The of Clini- Globalization consent of human quiring the informed (2001), http://www.oig.hhs.gov/ cal Trials subjects. Tellingly, the sources on which Sponsors oei/reports/oei-01-00-00190.pdf. outlawing non- government our relied conducting Investiga- under an research experimenta- human medical (“IND”) consensual Drug Application tional New are Nuremberg Code and the tion were the obligated regulations, to adhere to FDA Helsinki, suggests which Declaration require informed consent. conceived of these sources’ government (2008); § C.F.R. 312.20 The Globalization binding legal of the norm as a articulation Trials, at 5. Prior to supra, of Clinical al., obligation. supra, Bassiouni et April sponsors conducting research 310.102(h) § (citing 1625-26 C.F.R. guidelines obligated under non-IND were (1980)).13 Today, regulations require FDA principles to adhere to the ethical re- investigators’ informed consent to U.S. 1989 version of the Declaration of Helsinki search, domestically whether conducted country’s regulations, or the host whichev- country, support appli- in a used to foreign greater protection er to the human offered approval drugs. for the cations new See (2007); subject. § 21 C.F.R. 312.120 The 50.20, 50.23-.25, 50.27, §§ 21 C.F.R. Trials, supra, Globalization of Clinical at 5. 312.20, (2008); 312.120 45 C.F.R. April The 2008 revisions to the non-IND (2008). 46.111, §§ 46.116—.117 guidelines reaffirmed the informed consent Subject Human Protection: requirement. importance The that the United States Foreign Clinical Studies Not Conducted government attributes to this norm is Investigational Drug Appli- by willingness demonstrated its to use do- Under New cation, 22,800, 22,801, 22,803, compliance Fed.Reg. mestic law to coerce with the Principles importance of informed Ethical and Guidelines for the Pro- consent Research, Subjects part was tection of Human reinforced C(l) (1979), http://ohsr.od.nih. passаge Act in available at National Research gov/guidelines/belmonl.html# goc. which established the National Com- Soon after- wards, Health, Subjects Department Education mission for the Protection of Human (later Department of Biomedical and Behavioral Research. See and Welfare renamed the Act, 93-348, Services) promulgated National of Health and Human Research Pub.L. (codified regulations ensuring informed Stat. 342 as amended in scattered stricter U.S.C.). supported body of 42 This consent in research conducted or sections issued agencies. Report: Principles departments or See U.S. Belmont Ethical and Guide- federal Servs., Subjects Dep’t lines the Human of Health & Human Guidelines Protection for 1979, Involving Hu- Research in which identifies basic ethi- for Conduct of Research principles governing Subjects cal biomedical and be- man at the National Institutes of Health, (5th ed.2004), http://ohsr.od. subjects re- 17-18 havioral research on human quires nih.gov/guidelines/GrayBooklet 82404.pdf informed consent. Nat'l Comm'n for 46, (referencing subpt. Subjects pt. & 45 C.F.R. A Prot. of Human of Biomedical Research, (1981)). Report: Behavioral The Belmont 2008) (codified 22,804, 22,816 (Apr. customary international law. Convention 312). pt. Foreign 21 C.F.R. clinical stud- for the Protection of Human Rights and conducted under an IND must now Dignity ies not Being of the Human regard comply with Good Clinical Practice Application Biology and Medicine: (“GCP”) promulgated by the In- guidelines Rights Convention on Human and Biomed- ternational Conference on Harmonisation icine, 5, 15-16, art. opened signature Requirements Registra- ‍​​‌‌‌‌​​​‌​‌​​‌​​‌​​‌‌​​​‌​‌‌​​​‌​​​​‌‌‌​​‌​‌​​‌‍of Technical 4, 1997, Apr. E.T.S. No. http:// Use, tion of Pharmaceuticals for Human 62 conventions.coe.int/Treaty/en/Treaties/ 25,692 9, 1997), Fed.Reg. (May which re- [hereinafter Convention on html/164.htm quire informed consent to experi- medical Rights Biomedicine]; Human Conven- (2008). § mentation. 21 C.F.R. 312.120 Biomedicine, tion on Human Rights and Signatures Chart of and Ratifications as of Additional law sources Aug. http://conventions.coe.inV support the norm’s in- status Treaty/Commun/ChercheSig.asp? NT=164 European ternational law. The em- Union & CM=8 & & CL=ENG. DF=8/8/2008 prohibiting braced the norm nonconsensu- It provides that an “intervention in the experimentation al a 2001 through may only health field be carried out after Parlia- passed European Directive person given concerned has free and European ment and the Council of the informed consent to it” and that in- in- accepted Union. Directive formed subjects consent of human is re- principles formed consent of the 1996 ver- quired for their involvement in medical sion of the Declaration of Helsinki. Coun- research. Convention on Human Rights 2001/20/EC, (2), preamble cil Directive Biomedicine, supra, at art. 5.14 In 121) (L 37(EC) 2001 O.J. [hereinafter 2005, the General Conference of the Unit- Trial It required Clinical also Directive]. Educational, ed Nations Scientific and Cul- adopt protecting member States to rules (UNESCO) Organization tural adopted the incapable giving individuals informed Universal Declaration on Bioethics and permitting only consent and clinical trials Rights, Human requires prior, “the or, subject trial per- where “the when the free, express and informed consent of the consent, give is not able to son informed person concerned” for research-oriented legal his representative given has his writ- treatments. Universal Declaration on ten after being consent informed of the Rights, Bioethics and Human UNESCO nature, significance, implications and risks Res., Sess., Gen. Conf. at art. 33rd (2)(d). (1), of the clinical trial.” Id. at art. (Oct. 2005). C/Resolution required The Directive further all member implement by States to 2004 domestic history This illustrates that from its ori- laws, regulations, pro- and administrative gins with the trial of the Nazi doctors comply visions with its informed con- Nuremburg through its evolution inter- 22(1). requirements. sent Id. at art. conventions, national agreements, declara- 1997, thirty-four tions, Since member States of and domestic laws and regulations, Europe signed Council have also the norm prohibiting nonconsensual medi- Rights Convention on Human and Biomed- cal subjects on human has icine, binding convention and a firmly source become embedded and has secured Convention, rights protected 14. States-Parties to the including Convention on Hu- Rights right man and Biomedicine are also re- to informed consent to medical ex- quired "appropriate judicial protec- perimentation. to afford Rights Convention on Human Biomedicine, prevent infringements supra, tion” to or end at art. 23. (5 Wheat) Smith, community of States v. U.S. in the acceptance universal (1820), dissenting colleague’s 159-61, Story our 5 L.Ed. 57 Justice nations. Unlike analysis, customary diversity may found that “whatever be the essentially rests on the mistaken definitions, concur, which ... all of writers trea- that ratified international assumption robbery holding, depreda- or forcible of custom- only valid sources ties are ... upon piracy.” tions the sea is purposes, law for ATS ary international concluding 161. We have little trouble 200-02, we reach this con- Dissent at see hu- forbidding that a norm nonconsensual review of the a result of our clusion as experimentation every man medical bit interna- including multiplicity sources— as concrete—indeed even more so—than conventions, par- general whether tional piracy Story de- prohibiting the norm ticular, as identi- and international custom scribes, right with the or interference agreements, through international fied rights and the of ambassa- safe conducts pattern and a consistent declarations dors, together paradigmatic are the law-making national authori- action norms identified in Sosa. Id. at requires us to precedent ties—that our Code, Nuremberg S.Ct. 2739. The Article determining purpose examine for ICCPR, 7 of the the Declaration of Helsin- customary of a norm of inter- the existence ki, Rights the Convention on Human colleague’s dissenting national law. Our Biomedicine, the Universal Declaration on incompatibili- reasoning engage fails to Rights, and Human the 2001 Bioethics ty testing of nonconsensual human Directive, Clinical Trial and the domestic customary international law key sources of eighty-four laws of at least States all uni- statute, identified in Article 38 of the ICJ’s formly unmistakably prohibit custom, importantly international as most experiments beings on human without general practice accepted of a evidence consent, thereby providing their concrete law, general principles as well as the of law appellants content for the norm.15 The recognized supra civilized nations. See allege knowingly purpose- that Pfizer pp. 174-75. fully experiments conducted such on a Specificity uncertainty may ii large scale. Whatever margin exist at the is irrelevant here be- requires recognize that we causes Sosa appellants allege complete cause failure only those of action enforce part Nigerian on the of Pfizer and the international law norms are no “less government to inform appellants definite content ... than the historical [in] experiments. existence of the Trovan familiar was paradigms ATS] when [the true, if allegations, implicate These Pfizer Sosa, 732, 124 enacted.” 542 U.S. at S.Ct. Nigerian government and the in conduct prohibiting 2739. The norm nonconsensu- that is at the core of itera- experimentation al medical on human sub- reasonable jects requirement. prohibition against involuntary tion of the meets United see, fringe, disagreement subjects given placebos, 15. At the exists over cer- which some are Jost, aspects including, e.g., Timothy tain of informed consent S. The Globalization of example, Permissibility way consent Health Law: The Case Pla- to best secure Research, popu- 26 Am. J.L. & Med. from illiterate or otherwise vulnerable cebo-Based lations, see, al., (2000). e.g., Fitzgerald Daniel W. et 183-86 These debates do not disturb Comprehension During specificity in a of the basic norm at issue or Consent Informed Less-Developed Country, unanimity opinion against 360 The Lancet of world medi- (2002), subjects cal on human with- 1301-02 and whether informed con- possible experiments sent is in double-blind out their consent. prohi- European ments and the experimentation. passage medical While Union’s question applies testing to the of of the 2001 Clinical Trial Directive demon- bition only of human strates that States have not drugs without the consent sub- acted allegedly independently large-scale, Pfizer conduct- to outlaw jects on the scale non- ed, drug humans, that it would extend consensual suggest testing we do not but of routine or isolated failures have also acted in concert to to instances do so. words, professionals acting to obtain in- In other of a out sense of consent, concern, arising as those from mutual formed such “the nations [of world] business, allegations The in the have made it their simple negligence. through both anything involve but a doctor’s international accords and unilateral ac- complaints tion,” routine or erroneous failure to obtain such to demonstrate their intention to eliminate conduct patient. type alleged consent from his in the complaints. Filartiga, 630 F.2d at 889. Mutual Hi. Concern The administration of drug trials with- Customary international pro out informed consent on alleged the scale only transgressions that are of scribes complaints poses a real threat “mutual” concern to States —“those involv peace security. international Over the ... ing performed actions towards States’ decades, two pharmaceutical last compa- Flores, regard to the other.” with nies industrialized countries have looked (differentiating F.3d at 249 matters of poorer, developing countries as sites for “mutual” from those of concern “several” the medical research essential to the devel- concern, separately in which are “States opment of new drugs. See James V. Lav- interested”). independently Conduct ery, Putting International Research Eth- have prohibited through States do ics Guidelines Work Benefit of legislation mestic is also actionable under Countries, Developing 4 Yale Health J. the ATS as a viоlation of inter (2004); Pol’y L. & Ethics 320-21 national law when nations of the world Trials, supra, Globalization Clinical at “by have demonstrated means of express Pharmaceutical companies recognize 8.16 wrong international accords” that the is of potential drug benefits of poor trials to Filartiga, mutual concern. sought nations and have to promote access exclusive, important, 888. An but not to medicines and health care in under- component showing of this is a test populations through philanthropy served “capable im question the conduct partnership governments pairing peace security.” international See, PhRMA, e.g., NGOs. Press Releases: Flores, 414 Appellants have Industry Worldwide Pharmaceutical showings. made both of these Progress Launches Global Health Initia- seen, throughout Expand As we have States tive to Improve Efforts to Health 16, 2008), express Developing (April world have entered into two and in Countries binding agreements prohibit- http://www.phrma.org/news.jroom/press_ ing medical experimenta- releases/global_health_progress_initiative_ nonconsensual launched_to_improve_health_in_deve tion: the ICCPR and the Convention on Rights loping_countries/ (describing Human and Biomedicine. The en- initiative try agree- pharmaceutical industry of over 160 into worldwide to “fur- States these States, example, In the United creased sixteen-fold in the 1990s. Globaliza- Trials, foreign investigators number of clinical con- supra, of Clinical at 6. tion ducting drug research under an IND in- medicines; stability. The capacity peace build al and administration access to

ther nations; drug ad- of trials without informed consent on developing in health workers directly health in alleged complaints action to address the scale global vocate for develop R D to continue & threatens efforts because such con- challenges; and these plague in- fight tools to diseases duct fosters distrust and resistance to new PhRMA, world”); trials, Profile2008: developing drug cutting edge medi- ternational (2008), Industry http:// innovation, Pharmaceutical cal and critical 20Profile.pdf www.phrma.org/files/2008% pharma- initiatives in which public health by American (describing contributions companies play key a role. This ceutical pro- to the companies pharmaceutical supplies exceptionally good case itself to medicines and global motion of access why illustration of this is so. The Associ- care). possi- trend offers the health This that the Trovan reported ated Press trials health for the bility of enormous benefits engendered in apparently Kano such dis- community. Life-saving drugs can world population trust in the local that it was a developed quickly more and potentially be contributing factor to an eleven month- may countries be cheaply, developing long, boycott polio local of a vaccination given cutting edge access to medicines and 2004, in campaign impeded which interna- treatments to assist underresourced and tional national efforts to vaccinate the systems, health public understaffed polio population against outbreak with af- grapple life-threatening diseases catastrophic According results.18 to the flicting populations.17 their Organization, polio originat- Health World major ing Nigeria triggered а interna- promises The success of these efforts major tional play reducing role in the cross- outbreak disease between diseases, spread contagious causing spread border 2003 and it to across west, central, significant which is a threat to internation- and the Horn of Africa and acknowledged. 17. These benefits are well Id. An HIV researcher observed that even See, Nwabueze, e.g., Remigius companies drugs geared pa- N. Ethical Re- when test developed through Involving Subjects tients in the world trials in view Research Human countries, Issues, developing testing "brings Nigeria: Legal Policy ben- 14 Ind. Int’l patients. They get special (2003) efits to the atten- Comp. (recognizing & L.Rev. potential therapy.” tion provide only that clinical trials at times access to innovative and effective health care Rabiu, Nigeria 18. Salisu Asks Court to Wendler, Pfizer countries); developing David et Case, Press, July Dismiss The Associated al., The Standard Care Can Re- Debate: http ;//origin.foxnews.com/printer_ Developing search in Countries Be Both Ethi- friendly_wires/2007Jul04/0,4675,Nigeria Responsive cal and to those Countries’ Health Pfizer,00.html (reporting boycott that the Needs?, (2004) 94 Am. J. Pub. Health polio program the Kano vaccination is be- (noting inequalities dramatic in health care global lieved to have "set back eradication” of potential drug world-wide and the research polio and to have an outbreak that "caus[ed] poor). to better care for the world's spread the disease across Africa and into the Borders, WHO, Doctors Without East”). boycott impaired Middle The also organizations, other international health pharmaceutical compa- efforts of American example, corporate have called for increased polio nies to contribute to do- eradication developing research countries. interest nating polio over 130 million doses of vaccine Shah, Research, Globalizing Sonia Clinical to sixteen African countries since 1997. Nation, 3, http://www. PhRMA, June Partnerships: Global Humanitarian Ruth Fa- Programs Industry thenation.com/doc/20020701/shah. of the Pharmaceutical den, stated, Hopkins, (2004), bioethicist at Johns Developing http://www. Nations 4 need, anything, "What we if phrma.org/files/Global_Partnerships_2004. is more health world, developing pdf. research in the not less.” East, twenty ing drug the Middle and to re-infect trials on subjects human without informed consent. previously polio-free countries.19 reasons, For these we hold that drug The administration of trials with- appellants pled have facts sufficient to informed consent poses out also threats to state a cause of action under the ATS for a security by impairing national our rela- customary violation of the norm of interna- tions with other countries. Seven of the prohibiting tional law experimen- largest pharmaceutical world’s twelve subjects tation on human without their group manufacturers —a that includes Pfiz- instance, In consent. such an jurisdic- ATS companies. er—are American Global plaintiffs’ tion exists over claims. The dis- Fortune, July http://money.cnn. trict court determined that the norm exist- com/magazines/fortune/global500/2008/ ed, but concluded that single because no Consequently, industries/21/index.html. recognizing source the norm legally was companies likely spon- American are to be binding on the United States and created experiments sors of medical on human action, private cause of it could not infer illustrates, subjects abroad.20 As this case right such a under the ATS. Presumably, the failure to secure consent for human basis, on this it simultaneously held that potential gen- has the to there subject jurisdiction was no matter erate substantial anti-American animus Sosa, plaintiffs’ over claims. Under this hostility. Unsurprisingly, and as noted approach was not correct. Sosa makes above, 201-02, supra pp. govern- see our clear that the critical inquiry is whether actively ment attempts prevent this variety required sources we are practice foreign to consult customary countries. For exam- establishes a interna- tional law norm that sufficiently ple, requires specific, federal law that data generat- universally accepted, obligatory and ed testing subjects from on human abroad courts to recognize a cause of action to is used to regulatory approval seek enforce the norm. Nothing sug- Sosa must, minimum, for a given drug be the gests inquiry this can be halted if testing result of conducted consistent with some of the sources of international requirements of informed consent. giving rise to the norm are found not to be Consequently, government the U.S. denies binding explicitly or not to authorize a access to the U.S. market new cause of action. drug drug’s unless the research data is generated a manner consistent with the We believe that the issues raised this prohibit- international law norm appeal regarding customary international Organization, Poliomyelitis 19. World Health suggests industry 20. FDA data trend is to Nigeria Africa, in 2008, and June foreign West!Central support applications use research to http://www.who.in1/csr/don/2008_06_ drug approvals for new in the United States. 18/en/. explosion Since 1990 there has been an in the examples Other of the link between the foreign investigators number of clinical con- spread contagious cross-border disease and ducting drug sponsors research that use for peace stability international mind, come to purpose. there were 271 for- such as outbreak of anti-U.S. riots eign investigators conducting research in import- in South Korea as result of fear that By in the countries FDA database. spread ed American beef will mad cow dis- 4,458 grown investigators number had country. Sang-Hun, ease to that See Choe working in 79 countries. Globalization of Beef, South Korea Times, Ban on U.S. New York Lifts Trials, supra, at Clinical i. 26, 2008, http://www.nytimes. June com/2008/06/26/world/asia/26korea.html. They allege Nigerian gov- that the analysis by that law. by our framed

law are request to the provided contends ernment letter dissenting colleague. He of our Trovan, export from “whole FDA to authorize the analysis is created that our arranged for Pfizer’s accommodations at 191. We believe cloth.” Dissent Kano, facilitated the nonconsensual customary international approach his Despite IDH in Kano. unselfconsciously reactionary testing Nigeria’s law is epidemics, due to concurrent overcrowding does not accommo- approach static. that, by Nigerian government extended the ex- normative date itself to the world Pfizer, hospital conduct over the clusive use of two wards to their commitments including providing our Pfizer with control over scarce fifty years, past states — hospi- to exist. resources and the use of the public believe own—have shown and facilities to conduct the tal’s staff B. Action State test, Kano to the exclusion of MSF. A individual will be held private alleged unlawful conduct is to have The if in con under the ATS he “acted liable facility Nigerian occurred in a with the state, i.e., “under color of cert with” the Nigerian government assistance Kadic, making at 245. law.” 70 F.3d government employees officials and/or determination, courts look to the stan this Teaching IDH Aminu Kano from the developed finding state action dards in Kano Hospital. Pfizer’s research team § 42 brought claims under U.S.C. comprised physi- of three American was 1983, may § be Id. Under state action (a cians, physi- Dr. Dutse Abdulhamid Isa “there is such a ‘close nexus found when Teaching Hospi- cian in the Aminu Kano challenged the State and the ac between tal), Nigerian doctors. and three other ‘may seemingly private tion’ that behavior Nigerian members of The American and that of the it fairly treated as State be allegedly jointly Pfizer’s team adminis- ” Acad. v. Tenn. self.’ Brentwood Second Finally, tered the Kano test. in addition Ass’n, 295, 288, ary Athletic 531 Sch. U.S. test, assisting Nigerian with the Kano (2001) 924, 121 148 L.Ed.2d 807 S.Ct. alleged conspired to officials are to have v. (quoting Metropolitan Jackson Edison up by silencing Niger- cover the violations Co., 449, 95 42 419 U.S. S.Ct. physicians ian critical of the test and (1974)). may That nexus ex L.Ed.2d back-dating “approval letter” that the private operated ist “where a actor has protocol required FDA and international joint activity participant a willful with conducting the provided prior to be agents,” the State or its Gorman-Bakos v. experiment. In addition to these Schenectady Coop. Cornell Extension of explicitly the Adamu allegations, plaintiffs (2d Cir.2001) 545, County, 252 F.3d 551-52 “was allege Nigerian government (quoting Loce v. Time Entertain Warner contributed, aided, intimately involved and Partnership, ment Advance/Newhouse Pfizer’s efforts to assisted facilitated (2d Cir.1999)), F.3d or “acts to test,” “acted in concert conduct Trovan signifi with gether with state officials or Pfizer,” and, according Nigerian to a aid,” Kadic, 70 at 245. cant state experi- involved in the Trovan physician meets this test. Pfizer mentation, appeared the test- “back[ ]” pleading stage, these conten- Appellants alleged ing. have At the meet the state action test because Nigerian government was involved tions they adequately allege that the violations stages participated all of the Kano test and as the result of concerted action in the conduct that violated international occurred available, or if presently forum is not Nigerian govern- Pfizer and between remedy clearly so provides forum unsat- ment. inadequate that it is tanta- isfactory or Non II. Forum Conveniens remedy Piper to no at all. mount Aircraft & n. Reyno, Co. v. 454 U.S. 254-55 dismissal for failure an alternative to As (1981); 252, 70 L.Ed.2d 419 102 S.Ct. ATS, the district a claim under the to state (India), Int’l, Honeywell Ltd. v. USHA ground on the the actions court dismissed (2d Inc., Cir.2005); 421 F.3d No- Appellants non conveniens. of forum rex, 416 F.3d at 160. Ordinarily, we appeal. this issue on raised dismissal non conveniens review forum The defendant bears the burden Norex Petroleum for abuse of discretion. that a available and establishing presently Inc., Indus., Ltd. v. Access exists, adequate alternative forum and that (2d Cir.2005). filing appeal, Since public interest the balance however, Pfizer has notified Court heavily in favor of the alterna factors tilts particu- developments, of recent light (India), Ltd., 421 F.3d tive forum. USHA by the proceedings lar the initiation of 135; at PT Can Co. v. Crown United Cork Nigeria of and the government federal (2d Co., Inc., & 138 F.3d 74 Cir. Seal of against Pfizer and certain state of Kano 1998). showing inadequacy by a Absent affirmance it would not seek employees, its comity pre plaintiff, a “considerations on the basis of non judgment of the forum adversely judging clude a court from the appellants agreed conveniens. justice system.” PT quality foreign of a that the issue be remanded. requested also Co., Can 138 F.3d at 73. Accord United request. accede to this We the bears the initial ingly, plaintiff while producing corrup burden of evidence of not called Although we are now tion, delay process or lack of due the the district upon definitively to review forum, the defendant bears the foreign non conve application court’s forum as to the persuasion ultimate burden of niens, which frequency in view of the with See, Norex, e.g., of the forum. adequacy arisen and remained unset this issue has at 416 F.3d 159-160. case, guid we offer additional tled this granted the district court Pfizer’s parties and the district When ance to assist the motion, pivotal it issue as analysis set forth in identified three-step court. The plaintiffs produced sufficient Corp., Techs. 274 F.3d whether Iragorri v. United (2d Cir.2001) (en banc), is an inade- Nigeria to show that applies. evidence 71-75 III, forum. Abdullahi quate alternative litigation, step In the second this Having at found court 2005 *15. analysis, requires which the district WL not, Nige- had it concluded adequacy of the alternative to consider an forum. Id. at *16-18. forum, appro adequate ria was pivotal. is Dismissal is doing, avail In so the district court omitted adequate presently if an priate analysis discharged Pfizer its not exist. No of whether able alternative forum does rex, the court as to the persuading A forum in which burden of 416 F.3d at 159. availability of the pro adequacy present defendants are amenable to service placed Nigerian improperly forum and permits litigation cess and proving the burden of that the adequate. plaintiffs Id. at 157. dispute generally inadequate. Di- alternative forum is may nevertheless be inade Such forum Cf. Philip Corp., 294 F.3d reasonably Rienzo v. Servs. quate permit if it does not Cir.2002) (2d it (holding that is error dispute, if the 30 prompt adjudication of 190 application principle. their of a different burden

not “to hold defendants factors). remand, 637, 648, 650, A.2d On such proof’ of the Gilbert cases, opportunity required have an courts are court will Connecticut the district issue, as well as the rela- apply significant relationship” the “most to reassess (Sec- 44.1 Fed.R.Civ.P. tionship analysis between set forth the Restatement ond) (1971) Evidence. §§ Federal Rules of of Conflict of Laws & (Second)]. Restatement

[hereinafter III. Law Choice Conn, O’Connor, 649-50, 519 A.2d court dismissed the

The district claims under the Con plaintiffs’ Adamu 145(1) pro- Section of the Restatement Act and Trade Practices necticut Unfair rights vides and liabilities of the “[t]he Liability Act on Products Connecticut parties with to an respect issue tort are choice of law ground that Connecticut determined the local law of the state appli called for the principles applied and which, issue, respect to that has the Adamu, law. Nigerian cation of significant relationship most tо the occur- at 501-03. “We review dis F.Supp.2d parties principles rence and the under the trict court’s choice of law de novo.” Fin. (Second) § stated in 6.” Restatement Spe Ltd. v. Lehman Bros. One Pub. Co. 145(1). 6(2), turn, § provides Section (2d Fin., Inc., cial Cir. guided by where a state is not 2005). law, statutory directive on choice of correctly court The district deter factors relevant to choice of the mined that choice-of-law rules applicable Connecticut rule of law include obligated apply it was to applied because (a) the needs of the and interstate applica the state law that would have been systems, ble if the had not been transferred ease (b) forum, policies the relevant of the from Connecticut to New York. See Van (c) policies the relevant of other inter- Barrack, 612, 639, Dusen v. 376 U.S. 84 ested states and the relative inter- (1964). S.Ct. 11 L.Ed.2d 945 Under ests of those states the determi- law, delicti, Connecticut lex loci “the doc issue, nation of the particular rights trine that the substantive and obli (d) of a gations arising controversy protection justified out tort the expecta- tions, place are determined the law of the injury,” typically applies. v. O’Connor (e) policies underlying the basic the O’Connor, Conn. A.2d 13 law, particular field of (1986). require Lex loci delicti would the (f) certainty, predictability and unifor- application Nigerian law because the result, mity of and injuries plaintiffs’ alleged Adamu are (g) ease in determination ap- the Connecticut, have occurred there. howev plication applied. of the law to be er, conspicuously rig has retreated from a (Second) 6(2). application § id the doctrine. The Con Restatement The Con Supreme Supreme necticut Court held that lex loci necticut Court has determined 145(2) apply provides delicti does not to tort claim when that Section courts with doing guidance so expectations regarding would undermine the evaluation of the 145(1) parties important or an policy, policy state choices set out Sections 6(2). result, O’Connor, produce arbitrary and irrational 201 Conn. 145(2) justice” or where A.2d “reason and counsel for 13. Section assists with the significant relationship” 6 to “most test principles Section because application 145(2) of: by calling consideration it did not factor into its Section tort cases analysis integral set out in occurred, factors (a) injury place where 6(2). not, It example, Section did dis- (b) causing the conduct place where policies cuss “the relevant of the forum” or occurred, injury policies “the relevant of other interested (c) domicil, residence, nationality, and the relative interests of states those of busi- incorporation place place particu- in the determination of the states parties, ness of the (Second) lar issue.” Restatement (d) if relationship, where the place 6(2)(b)-(c). § analyze Nor did it what any, parties is centered. between “justified expectations” existed that could 145(2). (Second) § These Restatement reasonably prompted have Pfizer to be- according “to be evaluated factors are lieve that its conduct in Connecticut would importance respect with their relative law, expose it to Connecticut or how issue.” Id. particular Pfizer would disadvantaged by have been correctly court decided to The district litigating these claims Connecticut. apply 6 and 145 of the Restate- Sections 6(2)(d). § Finally, the district court did ap- than lex loci delicti. It ment rather ability not evaluate its own to determine 145(2) factors in Section to deter- plied the Connecticut, apply opposed as to Ni- Nigeria has mine whether Connecticut gerian, § 6(2)(g). law. Id. For these rea- significant relationship most to the sons, we vacate the dismissal of the state issue, which it identified conduct at law claims and remand to the district court failure to inform the children or “Pfizer’s for further consideration. potential problems about the parents their Trovan, and the administration of CONCLUSION dosage Trovan and low of Ceftriaxone.” (citations Adamu, F.Supp.2d reasons, foregoing For we RE- omitted). Nigerian It reasoned that “the judgments VERSE the of the district litigation stronger to this are than contacts proceed- court and REMAND for further particular and noted in Connecticut’s” ings. injuries plaintiffs’ both the and Pfizer’s in alleged Nigeria, conduct occurred in Judge separate WESLEY dissents residents, plaintiffs Nigerian the were and opinion. parties’ relationship that “the is centered” WESLEY, Judge, dissenting: Circuit in Id. It determined that most of Nigeria. 145(2) point toward the factors of Section majority The has undertaken to define a Nigerian law and that “sole applying the “firmly established” norm of international applicability basis” for the of Connecticut law, by unrecognized heretofore performed law was that “Pfizer research treaty obligation, American court or on the development respect and with to Trovan inadequate basis of materials for the task. planned experiment Connecti- law, deviating from our settled case reasons, For it cut.” Id. these concluded majority customary norm no identifies Nigeria’s superior interests were law, international it creates a new norm apply. that its law should majority’s out of whole cloth. Because the Although correctly analysis the district court misconstrues —rather than vindi- factors, law, customary I re- pertinent identified some of the it international cates— spectfully dissent. ultimately application erred its of the 192 (internal “extraordinary at 249

Proceeding quotation with care F.3d and altera- omitted). restraint,” v. Peru Copper Corp., agree Flores S. tions I with the methodol- (2d Cir.2003), 233, 414 248 Court ogy majority F.3d used to determine jurisdiction under the Alien upheld has jurisdic- whether a norm within falls Statute, (“ATS”), § 28 U.S.C. ATS, Tort grant agree tional of the but I do not alleging violations only a handful of cases against with their conclusion that a norm firmly international of the most established medical experimentation non-consensual norms, Karadzic, v. see Kadic (1) by private on humans actors is univer- Cir.1995) (2d 232, (genocide and 241-43 (2) obligatory sal and a matter of mutu- crimes); Shipping Amerada Hess war al concern. 421, Argentine Republic, v. 830 F.2d Corp. majority eight relies on sources (2d Cir.1987), on grounds, rev’d other support international law to its 683, 102 488 U.S. 109 S.Ct. L.Ed.2d determination that a against norm non- (1989) (free passage ship of neutral consensual medical on hu- waters); Filartiga international v. Pena by private mans actors is universal and (2d Cir.1980) Irala, However, obligatory. this evidence falls (state-administered torture). In Sosa v. quantum necessary far short of the

Alvarez-Machain, Supreme Court (1) establish the existеnce of such a norm: “paradigmatic” identified three such the International Covenant on Civil and norms, conducts, namely “violation of safe Rights Political has been described ambassadors, infringement rights Supreme Court as “well-known interna- 692, 724, piracy.” 542 U.S. 124 S.Ct. agreement! tional despite moral (2004). ] [its] 2739, 159L.Ed.2d 718 Rather than authority, utility,” little in defining ha[s] purposes declare that list exhaustive for Sosa, obligations, ATS, 542 U.S. at “any held that claim Court moreover, 124 S.Ct. it does present-day based on the law of nations actors, not apply [must] rest on norm of international such as the (2) accepted by action; character the civilized world Defendant in this the Council specificity comparable and defined with a Europe’s Rights Convention on Human 18th-century para to the features of the regional and Biomedicine—a convention— digms recognized.” we have Id. at was not ratified the most influential Accordingly, S.Ct. 2739. we are France, region, nations such as Ger- charged “vigilant doorkeeping” when many, Italy, Netherlands, Russia and reviewing ATS claims to ensure that Kingdom, promul- United and it was rest on “a narrow class of international gated April year one after norms” to the comparable paradigms iden (3) at litigation; conduct issue the by tified Supreme Court. Id. at UNESCO Universal Declaration 124 S.Ct. 2739. Rights Bioethics and Human of 2005 and (4) European Parliament Clinical Trial majority identifies three criteria post-date Directive of 2001 both also that must be satisfied before a violation of (5) period by years; relevant can time several international law be actionable under (1) the Declaration of Helsinki the ATS: that the norm issued specific is and (2) Association, definable, private World Medical a universally adhered to out of enti- (6) (3) ty, legal obligation, a sense of a the International Ethical matter concern, namely of mutual Involving a matter “in- Guidelines for Research Human volving Subjects performed promulgated by States’ actions towards the Council for Flores, or regard to the other.” 414 Organizations International for Medical consequences in international affairs Sciences, private entity, “ex- and is another asserted a the sensibihties and the therefore not matter of mutual concern. press[] of some countries and demands aspirations reasons, I For these conclude that non- are not “statements organizations” but experimentation by consensual medical obli- universally-recognized legal actors, though deplorable, is not (7) Flores, 262; 414 F.3d at gations,” actionable under international law and which, laws, unsupported domestic states’ affirm the would therefore district court’s accords, are not by express international complaints. dismissal of Plaintiffs’ purposes or relevant “significant 249; law,” id. at customary international DISCUSSION (8) Code, a Nuremberg the so-called Legally Obligatory I. Universal accompanied a principles statement Adherence verdict, possesses criminal best “subsid- decision, iary” judicial as a Statute value In a principle order for to become a art. Court of Justice of the International law, customary norm of international 59 Stat. June universally states must abide it ‍​​‌‌‌‌​​​‌​‌​​‌​​‌​​‌‌​​​‌​‌‌​​​‌​​​​‌‌‌​​‌​‌​​‌‍out of a (“ICJ Statute”). Taken to- U.N.T.S. legal obligation, merely sense of and not charting this evidence falls short of gether, Flores, 414 aspiration. See F.3d at 248. obligatory existence of а universal and obvious, It but might seem before one can non- against international norm actionable principle determine whether is universal actors under the ATS.1 government followed, ly one must define the principle law, that non- Like domestic support question. In of its determination interna unitary tional law not a monolith—a is set consensual indiscriminately applying is a matter of mutual con- of rules to all private actors cern, majority reasons that non-con- actors that come within its reach. To the experiments contrary, dis- international law consists of rules sensual medical breed states, thereby govern only rules that apply of medical interventions and trust spread private parties corpora of infectious diseases accelerate —individuals regulate rules that international borders. It is not tions—and other both across See, however, evenhandedly. e.g., tortious conduct Restatement enough, (Third) Foreign sort of international Relations of the United could create some (1987) (“Restatement § consequence. order for conduct to be States (Third)”). result, concern, Supreme of mutual it must “threat- As a Court matter required deciding has courts whether a consequences serious international en[ ] Sosa, principle affairs.” S.Ct. law U.S. an ambassa- norm to consider “whether international 2739. Such is the case when assaulted, scope liability for a example, dor is because extends upon sovereignty given perpetra violation of a norm to the “impinge[s] assault sued, being pri tor if the defendant is a foreign adequately nation and if not corporation vate such as a or individ redressed could rise to an issue of war.” actor Sosa, 20, 124 ual.” 732 n. experimenta- Id. Non-consensual medical 542 U.S. at S.Ct. 2739; at by private simply actors does not see also id. S.Ct. 2739 tion (“The J., (Breyer, concurring) norm must grave the same risk of serious present law, pleaded have not suffi- Even if we were to conclude that such a color of Plaintiffs impose liability applied cient state involvement to norm to state actors and that theory. See Part III liable if act under Pfizer under entities could be.held infra. liability type perpetrator to the 414 F.3d at consistently extend 247-48. We have actor) plaintiff a seeks to looked to the Statute as (e.g., private starting ICJ sue”). point determining proper sources See, e.g., international law. id. at 250- majority the norm at The lists issue 51; Yousef, United States v. 327 F.3d prohibition experi- here as the of “medical (2d Cir.2003). 100-03 That statute lists: human non-consenting mentation on sub- (1) conventions, “international whether 174-75, jects,” Maj. Op. proceeds general particular, establishing rules ex- analyze regard that norm without to the pressly recognized by contesting violator, alleged see id. at 174-88. Put (2) states”; custom, “international as evi- way, majority’s analysis another would general practice law”; dence of accepted as be no different if Plaintiffs had sued the (3) general principles “the recog- law of, Nigerian government, instead or in ad- nations”; and, nized civilized in certain to, broad, simplified dition Pfizer. Such a (4) “judicial circumstances decisions and ignores definition the clear admonitions of the teachings highly of the most qualified Supreme Court—and conflicts with publicists nations, of the various as subsid- prior decisions of this a Court—that cus- iary means for the determination of rules tomary international norm cannot be of law.” ICJ Statute art. 38. identity divorced from the of its violator. ability The pick and choose from this majority’s analysis The omits this critical seemingly limitless menu of pres- sources result, majority consideration. As ents real threat of interpreta- “creative opinion only presents equation. half of the Flores, 248; tion.” 414 F.3d at see also mind, my majority To should have Hess, (Kearse, Amerada asked customary whether international law J., dissenting). risk, mitigate To prohibits private actors from medical ex- to prevent courts from becoming “roving perimentation on non-consenting human Flores, commission[s],” 414 F.3d at we subjects. That question must be answered have, cases, in our methodically assessed negative. weight and relative influence of not only each class of sources listed the ICJ A. Majority’s Sources Custom- Statute, many but individual sources with- ary International Law in each class. The near-infinite list of Flores, explained we some of the international law sources makes adherence inherent in determining difficulties what precedent to this paramount impor- customary offenses violate tance, for our analysis demonstrates law: every source of international law car- equal weight. ries

Customary international law is dis- myriad cerned from decisions made in following Instead of applying our framework, numerous and varied international and majority substitutes its Furthermore, domestic arenas. place the rel- compelling narrative. Over the evant evidence of customary internation- only pages, course of a few majority al widely dispersed law is generally employs several sources it believes lawyers unfamiliar judges. customary demonstrate a against norm These difficulties compounded by are experimentation by non-state enti- the fact international law ties together and weaves them to reach its ... does not stem from single, Maj. de- Op. conclusion. See at 175-85. No- finitive, readily-identiflable source. majority where does the examine these

195 a. International Covenant on required by Sosa. in the context sources weight Rights Civil and Political the majority does discuss The collectively sources, they how these of The International Covenant on Civil and norm, how demonstrate Rights, Doc. Political Dec. S. Exec. compares that norm supporting evidence 95-2, E, I.L.M. 368 U.N.T.S. they done Had precedent. our ATS (ratified by the United States June so, my colleagues would hopeful I am 1992) (“ICCPR”) “guarantees a broad I do—that the same conclusion that reach political of and rights civil spectrum actors, experimentation by signatory within nations.” individuals un- is not actionable reprehensible, while Duarte-Acero, 296 F.3d United States v. international law. der (11th Cir.2002). 1277, of those One be medi- rights- free non-consensual —to 1. & Conventions Treaties experimentation cal or scientific stated —is Flores, are the In noted treaties we Article 7. customary interna- strongest evidence appropriate The ICCPR is not evidence obli- they legal “create tional because customary international law for at least on obligations akin contractual gations First, Supreme reasons. two Court 414 F.3d at parties to them.” the States explicitly described the as a Sosa ICCPR formal primarily to the “[W]e 256. look agreement! “well-known international ] lawmaking and official actions States that, despite authority, moral ha[s] [its] prac- as evidence of the established ... utility out in little under standard set at Yousef, 327 F.3d tices of States.” opinion,” because “United States equal. Although are But not all treaties understanding express ratified on the [it] by have been ratified at treaties that “[a]ll self-executing that it was not and so did evidence of provide two States some least obligations not itself create enforceable ... a of nations practice the custom and 734-35, the federal courts.” 542 U.S. at proof treaty only will constitute sufficient added). 2739 (emphasis 124 S.Ct. if customary international law a norm of majority have overwhelming of States Second, limited weight whatever Flores, at treaty.” ratified action, it regard has with to state ICCPR Moreover, weight to “evidentiary nothing prohibit- that a does to show norm treaty given greatly be afforded to a varies ing involuntary medical (i) which, many, how depending citing its applies to non-state entities. (ii) treaty, have ratified States majority seemingly language, the universal actually im- to which those States degree section, operative the ICCPR’s overlooks set principles plement abide Party requires “[e]ach State For treaty.” in the 256-57. forth respect to ensure ... ] undertake! instance, ratified the United treaties territory and within its to all individuals if evidentiary are value greater States jurisdiction recog- subject rights to its self-executing are either or executed in the ICCPR present nized Covenant.” See, e.g., acts id. through Congress. 2(1). text, Thus, its broad despite art. 257; Nat’l Bank Barclay Khulumani v. terms, only governs own ICCPR its (2d Cir.2007) (Katz- Ltd., relationship “the between State mann, J., concurring). territory.” individuals within the State’s Duarte-Acero, Because F.3d at 1283. primarily on two majority relies flow- only obligations creates the ICCPR treaties. ing persons from a state to within European its states. See Statute of the Coun- territory, a non-state actor cannot be said cil of Europe, May art. E.T.S. Thus, it. have violated the ICCPR was No. 1. It is difficult to see how the Con- (decided Filartiga relevant in before the vention demonstrates the universality of Supreme utility), limited its Court the medical experimentation principle context of state-administered torture of when signatories its are limited to one one of its citizens in contravention of one continent. majority The also notes that rights guaranteed by of the states in the the Convention has been signed by thirty- states, ICCPR. See 630 F.2d at 884. But whatev- Maj. four see Op. at but over- evidentiary er its value had Plaintiffs sued only looks that it by has been ratified Nigerian government, the ICCPR twenty-two, treaty only and a evidences clearly question has none where the practices the customs and of states that whether international law includes a Flores, norm have ratified it. 414 F.3d at 256. against actionable corporation. Lastly, and perhaps more importantly, the

Convention is lacking even as evidence of a b. Convention Rights on Human European norm, since it has not been rati-

and Biomedicine by fied the more influential European states, France, including Germany, Italy, The second treaty by cited majority Netherlands, Russia and the United is the Convention on Human Rights and Kingdom, treaty’s and a evidentiary value Biomedicine, 4, 1997, Apr. E.T.S. No. 164 increases along with the influence in inter- (the “Convention”), promulgated by the national affairs of the states that have Europe. Maj. Council of Op. See at 183. 257; ratified it. See id. at Convention on Articles 52 and 16 of the Convention Rights Human Biomedicine, Chart of require subject of scientific re Signatures and Ratifications as of Decem- search give his or consent, her informed ber http://conventions.coe.int/ which may be any withdrawn at time. = Treaty/Commun/ChercheSig.asp?NT problem first majority’s with the & CM=8 & DF= & CL=ENG 12/23/2008 reliance on the Convention is that it is a (“Convention Chart”). Ratifications regional agreement signed by the most influential states in the region. second, Member- A more fundamental problem ship in the Council of Europe is limited to with majority’s reliance on the Conven- 2. Article 5—General rule ii. may risks which be incurred An person intervention in the may only health field disproportionate are not po- to the be carried person out after the research; concerned tential benefits of the given has free and informed consent to it. iii. project the research approved has been person This shall given beforehand ap- be competent body independent after propriate purpose information as to the merit, examination of its scientific includ- nature of the intervention as well as on its ing importance assessment of the of the aim consequences person and risks. The con- research, multidisciplinary re- may freely cerned any withdraw consent at view of acceptability; its ethical time. persons undergoing iv. research have rights been informed of Article their persons 16—Protection the safe- undergo- ing guards prescribed research protec- law for their tion; person Research may only on a be under- necessary taken if all v. following provided consent as for un- conditions are met: der Article given expressly, 5 has been spe- i. there is no comparable alternative of cifically effec- and is documented. Such consent humans; tiveness to research on may freely be withdrawn at time.

197 Flores, sought to plaintiffs In demon- promulgated it was tion is that after customary by international ref- strate know no au I of at issue here. conduct to multinational declarations. In erence facto post ex thority an international for declaration, that a response, we noted by nations later the law of of definition may by “which be made a multinational Vietnam, Ass’n signed treaties. for Cf. States, body, byor or more customari- one v. Orange Dow Chem. Agent Victims of policy statement of ly general is ‘mere Cir.2008) (“The (2d Co., 104, 118 517 F.3d give to ... unlikely is rise obli- [that] Gene ratify not States did United ” any strict sense.’ gation[s] Accordingly, the until 1975. va Protocol (quoting Oppenheim’s Interna- at 262 have constituted cannot be said to Protocol (Sir Jennings Law & tional Robert States,’ treaty 28 U.S.C. ‘a of the United ed.1996)) (al- Watts, eds., Arthur 9th Sir period relevant to during § original). “Such declarations terations Trovan allege Plaintiffs appeal.”). invariably political almost state- are April of testing March occurred expressing the sensibilities ments — opened was not but the Convention of aspirations the asserted demands 4, 1997, and did signature April until for organizations countries or some —rather ratifica bind state until Slovakia’s universally-recognized of than statements Flores, January 1998. See tion result, obligations.” we legal Id. As 256(“A only becomes bound State cоncluded that “such declarations are not is, treaty to—a by party becomes a —that proper evidence internation- treaty.”); it ratifies the Convention when Id,, added). (emphasis al law.” is The Convention Ratifications Chart. Flores, rejected In the declarations we inquiry. other import to this Two without put govern- were forth international majority, sources cited post-1996 bodies, Organization of Ameri- mental the 2005 Universal Declaration UNESCO Nations can States and United Confer- Rights and the on Bioethics and Human Development. on Environment and ence Trial European Parliament Clinical Here, Id. at 263. the two declarations equal evidentiary irrele Directive share majority put were for- embraced same vance for the reason. by entirely private organizations— ward hardly evidence of the state of internation- Helsinki was al law. The Declaration of 2. Multinational Declarations Association, by the World Medical adopted Principle states, not member group comprised majority cite several Plaintiffs and physicians private national med- but of declarations, including the multinational “The As- ical associations. World Medical Declaration World Medical Association’s (WMA) organ- anis sociation Ethical Helsinki and International representing physicians .... [and] ization Involving Human for Research Guidelines always an independent has been confeder- Subjects by the Council promulgated associations.” professional ation free Organizations of Medical Sci- International Association, The See World Medical (“CIOMS Guidelines”), as additional ences WMA,” http://www.wma.net/e/ “About the prohibition against non- evidence that the express terms of the about/index.htm. ap- consensual medical abundantly make it Declaration of Helsinki so, doing plies hortatory, obligato- non-state actors. that it and not clear our “The Association majority ry: somehow overlooks decisions World Medical (WMA) developed Declaration of has in Flores and Yousef. princi- by wholly organizations, statement ethical but incap- Helsinki as a ” creating binding Ass’n, legally obligations. able of ples .... World Med. Declara- See Principles tion Ethical Helsinki: State Practice Involving Human Medical Research Sub- majority points great The also A(l), jects Similarly, art. June 1964. that, respective number of states in their non-govern- “an international CIOMS is laws, require domestic informed consent in CIOMS, mental, non-profit organization.” many medical That research. countries CIOMS?”, http://www.cioms.ch/ “What is have prohibited actors from con- jan2008_whatis_eioms.pdf. ducting experiments medical or treatments Treating well-meaning, aspiration- these certainly without informed consent is com- al, as private, but declarations sources of worthy praise, mendable and but not law runs counter to our international ob- “significant purposes or relevant for private per- servation in that “no customary international law.”4 See Yousef group son—or of men and women such as Flores, 414 only F.3d at 249. For it is comprise body of international law prohibit when states domestic action as a 327 “express scholars—creates law.” F.3d at result of international accords” good 102. so for that a wrong This is reason. As we becomes a violation of cus- tomary have international law. See jurisprudence, Filartiga, seen our ATS inter- 630 (quoting F.2d at 888 IIT v. gives Vencap, national to legally custom rise en- (2d Ltd., Cir.1975) obligations. forceable polit- To include the J.)). (Friendly, No such international ac- private organizations ical statements cord exists here. the select group and conscribed sources capable creating international would Moreover, uniformity” “substantive non-democratic, enfranchise unaccountable among states’ is only domestic laws a governmental authority. entities with As starting point demonstrating interna- result, these declarations are “not tional proper through custom individual state practice, “pro- evidence of international which should also reflect a law.” Flores, cedural” among at consensus states on how F.3d prosecuted behavior should be —crimi- majority The focuses on its lens one line Sosa, nally civilly. See 542 U.S. at Filartiga proposition that a 761-62, J, 124 S.Ct. 2739 (Breyer, concur- may by “declaration custom recog- become ring). Breyer As Justice in his noted Sosa laying nized binding as down rules upon concurrence, the states of the world have Maj. Op. States.” 177 (quoting at procedural reached both substantive and 883). Filartiga, In Filartiga, agreement respect only handful discussing we were a United Nations dec- of certain international law norms made laration, though binding, “cre- against actionable non-state entities. See ates an expectation of adherence” because 1(B) id.; Part Non-consensual infra. it “speeif[ies] with great precision the obli- testing among is not them. gations of member nations.” F.2d at 4. The Code Nuremberg The declarations on relied

majority put govern- were not forth majority analysis The centers its around mental body Nuremberg Code, but, such as the process, United Nations in the 4. Reliance states' on domestic laws also II. raises questions mutuality, discussed at Part infra Roosevelt, (signed by Bull. President genesis and status

critically its misstates Prime Churchill and Sta- Maj. Op. 177- Minister Premier law. See in international lin). generis a sui The statement added that German the Code is 79. Because law, context is have particu- its criminals “whose offenses no of international source it understanding is—and ... will be geographical what lar localization vital joint punished by govern- it is not. decision what Allies.” ment of the unquestion- Nuremberg trials are victory Europe the sur- Following country’s greatest and one of this ably Germany, Allies render of executed to the field of contributions enduring most August the London estab- early As Charter law. contemplated bringing Military Nazi Tribunal powers lishing an International Allied criminals,” justice try “major after the conclu- London criminals to to war war At the Charter, World War. for the Agreement of Second Prosecution sion Conference, Major Moscow of the October 1943 and Punishment War Crimi- States, 8, and Kingdom Axis, 3, Soviet European Aug. United nals art. United of the on Atroci- joint 1945, 279, “Statement 1544, issued and Union 59 Stat. 82 U.N.T. S. ties,” that: warning open the door for other war crimi- leaving any any of armistice nals tried in other “national or granting

At the time of to be may up be government occupation might which set court” that estab- any to be and lished, German officers 6. Germany, Alongside in those id. art. the London party Charter, of Nazi who and members Allies promulgated men the Char- have for or taken responsible have been Military ter of the International Tribunal atrocities, consenting part the above with and formed four-member tribunal be executions will sent massacres and by each the Al- appointed one member of their to in which abo- lies, back the countries “the jurisdiction major over war with in order that minable deeds were done committing of three criminals” accused ac- may judged punished be peace,5 against crimes: crimes war liberated cording the laws of these crimes,6 humanity.7 against and crimes governments free which countries and of Military Tri- Charter of the International be erected therein. will 6, 2, bunal, Aug. 59 Stat. arts. 279. It was the Interna- of 82 U.N.T.S. Statement Atroci- Moscow Declaration Military tional that conducted the ties, Dept of Tribunal 9 U.S. State Oct. public private property, or wanton destruc- Against Peace” were defined as 5. "Crimes cities, villages, waging tion towns or or devastation “planning, preparation, initiation or justified military necessity.” Charter aggression, war in violation a war or a treaties, Military art. agreements or of the International Tribunal assur- of international ances, 6(b). plan participation or in a common or accomplishment any conspiracy Against Humanity” were defined "Crimes foregoing.” the International Charter of "murder, extermination, enslavement, de- 6(a). Military art. Tribunal portation, and inhumane acts commit- other any against population, ted before or “violations civilian "War Crimes” were defined as war; persecutions political, during the or on laws of war. Such viola- of the or customs include, to, religious grounds in execution of or racial or shall but not be limited tions murder, juris- any with crime within deportation slave connection ill-treatment Tribunal, whether or not purpose of civilian diction of labor or other country occupied territory, violation of the domestic of the murder population of or persons perpetrated.” Charter of the Interna- where prisoners of war or or ill-treatment of 6(c). seas, Military art. hostages, plunder tional Tribunal killing of on the convic- against humanity, conspiracy, trial resulted in the celebrated defendants, including 10 of charging tions of 19 of the defendants with mem- “SS,” bership organization officials Hermann Goer- high-ranking Nazi de- Hess, Karl ing, Doenitz. See criminal Rudolf clared the International Mili- Jackson, Report tary H. Final generally Robert Tribunal. Id. at 8-18. These charges Nuremberg primarily, to the on the Trials were on premised, President the defen- (Oct. 1946). Nuremberg experiments, But the Code forced dants’ a different in a adopted by performed was tribunal constituted war crimes when war, different trial. prisoners against crimes hu- manity when Nazi conducted on concentra- Four after the London Charter months camp prisoners. tion Military International Tri- established the bunal, Council, joint Case, the Allied Control At the conclusion of the Medical governed entity post-war allied Ger- 16 of the were defendants convicted of many, enacted Control Council Law No. more charges, one or of the and seven each occupying ultimately which authorized were sentenced death. Allies, Occupa- verdict, within its own “Zone of Along their the military tion,” prosecute “persons to judges principles arrest enumerated ten that suspected having within such Zone of com- to came be known the Nuremberg as crime,”8 subject Code, mitted a right to a of first the first of which states that in by Military refusal the International Tri- experiments, medical “voluntary the con bunal. Allied Control Council Law No. 10 the subject sent of human is absolutely (Dec. Ill, 20, 1945), §§ art. 1 in Trials essential.” 2 Trials Criminals War Be of War Criminals the Nuernberg Nuernberg Military the Tribunals of Before fore Military Tribunals Under Coun- Control Under Control Council Law No. (William (William Inc.1997) cil Law No. XVTII Hein & Co., S. S. Hein (1949), & Co., 1997) (1949), Inc. http:// available at at 7 http://www.loc.gov/rr/frd/ available www.loc.gov/rr/frd/Military_law/pdf/NT_ Military_law/pdf/NT_war-criminals_Vol-II. (“1 (“2 ”). war-criminals_Vol-I.pdf pdf Trials War Trials War Criminals of of ”). Criminals My colleagues contend that the Code the American arising first of naturally trials flowed from principles the of law under Control Council Law No. was the in espoused the London Charter. They against “Medical course, Case” German doctors. quite right, are that Control On October the American Office Council Law No. 10 was modeled after the of Military Germany Government for en- London Charter and the American and acted constituting General Order Mili- military International tribunals shared tary 1, comprised Tribunal of three Ameri- largely general same international law can military judges and one alternate procedural frameworks. The London judge. Id. at That day, Brigadier same Charter identified and certain in- defined Taylor, General Telford Chief Counsel Against ternational offenses—Crimes Crimes, signed War an Humanity, Peace, indictment in Crimes Against and War Brandt, United charg- States v. Karl et al. Crimes—while each of the twelve trials ing crimes, defendants war crimes military before the American tribunal con- In addition the three organization to in the group crimes listed or declared criminal Tribunal, Charter of the International War Military the International Tribunal.” Control Law Control Council No. 10 added a fourth— II, (d). § Law Council No. 10 art. "Membership categories of a criminal import that continues context for cant to unique and horrific cerned —influence crimes, ranging day. surely evidentiary The Code this has of those commission experimentation prisoners inquiry, nothing in our but there is medical value from example, slave labor. For establishes to use of indicate the Code Humani- Against of Crimes non- prohibiting the definitions norm of international law the Nazi under which ty Crimes and War or consensual Case tried the Medical doctors were actors, compen- by private or treatment virtually identical to those were virtually for the non-existent eviden- sates However, majority Charter. London cited of the sources tiary value other Nuremberg fact that overlooks majority. general princi- not with these Code dealt obligation of our Conscious measure law, very with the ples but instead of the of international weight sources exper- permissible medical specific issue of aggregate, is the sum of law the what es- principles The ethical imentation. the sources serve as the cornerstone forebears in the Code had no poused majority’s ICCPR, conclusion? The judg- London Charter or either the Supreme Court characterized Military Tribu- International ment of the Sosa, “little being utility,” U.S. at exclusively in developed were They nal. 2739, which, any event, 124 S.Ct. Case. the Medical actors; apply private pair does not history suggest not to I recite organizations’ declarations our Nuremberg Code is not extraordi- precedent proper tells us “are not Circuit document, but nary groundbreaking law,” evidence difficulty inher- to demonstrate rather Flores, 262; regional 414 F.3d at one con- measuring evidentiary weight, its ent and two multi-national declara- vention catego- neatly any it fit into of the not does period time post-date tions that the critical for sources of has identified ries this Court irrelevant; completely and are thus states’ thing, law. For the Code one international any laws to interna- domestic untethered mili- developed by the States United was are told is agreement tional that we mili- by American and announced an tary purposes of “significant relevant Stanley, v. See United States tary court. law,” at customary id. international 107 S.Ct. 483 U.S. Code, 233; Nuremberg a 414 F.3d (1987) (Brennan, J., dissent- L.Ed.2d 550 evidentiary value is whose un- document treaty not a Certainly, Code is ing). clear. bind state. immediately did not put, the here does not Simply evidence framework of the ICJ Statute— Under the forward in compare put with sources it and, accordingly, this Court —because a princi- where have held the few cases we verdict, its closest of a criminal part was customary internation- to a norm of ple be decision, judicial judicial but analogue is “extraordinary care Exercising al law. rather only “subsidiary,” are decisions restraint,” have only see id. at we customary inter- sources of primary, than where jurisdiction in cases 38; upheld ATS art. law. See ICJ Statute national customary international law my evidence I with Maj. Op. agree at 173-74. Filartiga, entirely overwhelming.9 In signifi- was that the Code has had colleagues jurisdiction that the ATSconferred over majority purports our recent “held to include corporations purportedly that Barclay National multinational Khulumani v. decision in Ltd., Cir.2007) (2d government of South (per with the collaborated Bank curiam) maintaining apartheid because stating that it group, this select Africa by spect the fact that the to each persuaded we were defendant was “clear and Flores, surrounding unambiguous.” consensus tor “international 414 F.3d at 252. case, expression ture found numerous In has each the nations of the world ratify treaties and accords.” 630 gathered international universal numbers added). There, (emphasis specifically F.2d at that prohibited geno- treaties political cide, torture, crimes, State branch war Department attacks on —“the responsibility conducting principal ships neutral in generalized human —not rights agreements international relations United but in accords with pr Flores, States,” 262—had ex those discrete norms as their exclusive essly prohibition announced that subjects. against had ripened torture into norm My colleagues contend I only that look Filartiga, international law.10 (or, case, presence to the in this the ab- Kadic, In 630 F.2d at 884. we observed sence) globally treaty of a ratified as the was included in genocide section 404 exclusive of an source law the Restatement and the Conven norm. Far from it—we have held that Punishment tion on Prevention and customary international law “does not the Crime Genocide had been ratified single, definitive, from any readily- stem nations, including more than 120 the Unit However, identifiable Id. at source.” 240-42, States, ed 70 F.3d at while interna great weight jurisdiction of ATS must tional criminalization of war was crimes upon a sturdy rest foundation enough to Conventions, four established Geneva it. suрport Just as it be would error to nations, more ratified than 180 includ stubbornly require one source sufficient ing States, id. the United 242-43. strength own, on bear burden its Hess, similarly

Amerada it was obvious majority equally mistaken in its that Argentina’s Falkland War attack attempt employ series of extraordi- ship American violated one of the oldest narily weak sources to purported secure a customary international law norms. of customary norm international law. Our variety F.2d at 423-24. cited a We case makes clear even when international accords establishing right collectively, viewed these sources are in- of a ship neutral to passage. free Id. at capable carrying the weight placed upon 424. tracing After the norm to Black by my colleagues. them stone, “beyond we concluded that it was controversy attacking that ship neutral ¿OJ § B. Restatement ... international waters violates inter purported Nor does Plaintiffs’ norm re- national law.” Id. semble the select few norms cases, In those the evidence of interna- liability international pri- law extends tional acceptance of each norm re- Although with vate actors. the law of nations aided customaiy and abetted plaintiffs violations of in- alleged of whether had such a viola- Maj. Op. law.” ternational at 174. To the that the tion defendants could have been lia- contrary, Khulumani, jurisdic- aiding Khulumani did not confer abetting. ble for See any

tion and did not make on F.3d at determination 504 260. plaintiffs whether had stated a violation Indeed, merely international law. It held that the Supreme Court later declared 10. actions, concluding district court erred in that in ATS "federal courts should convey jurisdiction ATS did "aiding not give weight serious to the Executive Branch's abetting impact foreign violations of policy.” interna- view of the case's law,” Sosa, tional and remanded for consideration 542 733 U.S. at n. S.Ct. actor, only to non-state we reviewed not its reach “confine[ ] does not general Restatement, Kadic, a host of action,” but relevant inter- 70 F.3d see state accords, leading us to spe- national conclude consider whether must still courts terms, Kadic, prohib- their own the norms In we at issue does. cific norm (Third) genocide applied war crimes iting of For- the Restatement noted that individuals, while torture and sum- States Law of United eign Relations mary proscribed execution “are interna- “those violations between differentiates only when committed by a tional law state when committed that are actionable color of law.” Id. at 241- category of officials under and a more limited state11 “ added that ‘color of law’ equal force to 43. We apply violations” § jurisprudence of U.S.C. 1983 is a (citing Id. at 240 Restate- private actors. 702). (Third) guide relevant to whether defendant has §§ Section 404 of ment purposes in official action for engaged universal crim- Restatement authorizes jurisdiction [ATS].” entities “for under the jurisdiction inal over non-state by the commu- recognized offenses certain later, years again Five we determined concern, as of universal nity of nations law applied whether international norm trade, attacks on or piracy, such as slave Bigio only to state actors. See v. Coca- crimes, aircraft, genocide, war hijacking of (2d Cir.2000). Co., Cola terrorism, acts of evеn perhaps certain Kadic, juris Building on we held that ATS jurisdiction] other basis [no where non-governmental entity diction over a re jurisdiction, not to Universal present.”12 quires the violation of a norm “listed as an acceptance of a confused with universal be §in ‘act of universal concern’ 404 or ... purposes, “permits State norm for ATS sufficiently [those] similar to acts for us to nationality an offender of prosecute though incorpo treat them as were committed outside of for an offense § by analogy,” rated into or conduct to that State.” and without contacts State under color of law. Id. at 448. committed F.3d at 103. Yousef, 327 dismissal, affirming the district court’s act at alleged that Ra- we determined that the issue—dis plaintiffs Kadic Karadzic, criminatory expropriation property “president” dovan —is listed in section Srpska violated much more like the acts self-proclaimed republic norms, notably than those in section and that the several allege that Coca-Cola complaint crimes and torture. did genocide, bans on war Egyptian state offi- Treating Karadzic as a acted concert with 70 F.3d at 236-37. explained application its of a provides: 12. The Court 11. Section 702 if, provision criminal law to civil statute A violates international law as a state "per- noting to section 404 policy, practices, it encour- that comment matter of state ages, appropriate or condones civil reme- mits states to establish (a) genocide, dies such as the tort actions authorized trade, (b) slavery or slave Kadic, (citation 70 F.3d at 240 omit- [ATS].” (c) disappear- causing the the murder or ted). specifically, "jurisdiction More on the individuals, ance of (d) has been exercised basis of universal interests cruel, inhuman, or torture or other law, criminal but international in the form of degrading punishment, treatment or preclude application not of non- law does detention, (e) prolonged arbitrary basis, example, by law on this criminal discrimination, (f) systematic or racial remedy providing a in tort or restitution for pattern gross (g) of viola- a consistent (Third) piracy.” Restatement victims of internationally recognized human tions of § 404 cmt. b. rights. 204 However, at 447-49. in “sufficiently

cials. Id. unlike similar” to those acts sup to Kadic, beyond no to look port we saw need application private its to a corporat Restatement to sources of internation- Bigio, ion.14 See 239 F.3d at 448. This al conclude that law order to the norm Court has never had occasion consider apply did not to non-state entities. types Com- what “sufficiently acts are simi 448, Kadic, pare id. at 70 F.3d at with lar” to the section 404 except acts to con It equally 241-43. is clear that section 404 in Bigio clude that discriminatory expro of the Restatement does not priation reveal a norm among was not them. Id. For customary prohibiting reasons, international law similar neither is non-consensual non-consensual medical experimentation.

by private actors. jurisdiction Universal originated with reiterate,

To section 404 only prosecutions lists five piracy years more than 500 specific acts for which ago. universal criminal Yousef, 104; See 327 F.3d at United jurisdiction over pi Shi, (9th actors exists: 709, States v. Lei trade, Cir.2008). racy, genocide, crimes, slave war explained As we in Yousef, pi- and attаcks on aircrafts. racy See also Viet universally punishable is not because nam Ass’n Agent Orange, Victims it uniquely heinous but “because of the (describing five these threat piracy poses orderly trans- comprising principles may “the list of port and commerce between nations and be said to have ripened universally into because ‍​​‌‌‌‌​​​‌​‌​​‌​​‌​​‌‌​​​‌​‌‌​​​‌​​​​‌‌‌​​‌​‌​​‌‍the crime statelessly occurs on the (in accepted norms of international high law” 1822, seas.” 327 By F.3d at 104. it omitted)). quotation ternal marks any If beyond was ... “doubt that vessels and thing, this Court has been even more property possession in the pirates may stringent, holding that in spite of the lawfully Re be seized on the high seas statement, federal try courts [any] could not person, and brought adjudica- in for alleged airline customary bomber under tion.” United v. States the La Jeune Eu- international law principles jur (C.C.D.Mass. genie, 832, universal 26 F. Cas. 1822) (No. isdiction.13 Yousef, See 15,551); 327 F.3d at 103- see also United States Regardless, 08. dispute Smith, there is no v. 18 U.S. 5 Wheat. none of (1820) the five acts in J.) section 404 encom L.Ed. 57 (Story, (discussing the passes non-consensual medical experimen jurisdiction bases for universal over pira- Instead, tation. argue Plaintiffs cy). that it is charged

13. Yousef was placing a bomb whether or the offence was committed in Philippine aboard a jet flying Airlines from territory, its compe- to submit the case to its Philippines Japan. 327 F.3d at purpose prosecu- tent authorities for the holding customary After international tion.”), id. at 108-10. support could not jurisdiction, universal we may diverge observed that "treaties broad- I note the holding tension between our ly law,” from id. at can, Bigio that theory, acts at least in be upheld jurisdiction under 18 U.S.C. incorporated § by analogy into for ATS § implementing statute the "extradite purposes, see 239 F.3d at and our state- prosecute” provision of the Montreal Con- "strictly ment in that the limited set of Yousef Suppression vention for the of Unlawful Acts subject jurisdiction crimes to universal cannot Against Safety the (Sabotage) of Civil Aviation expanded by drawing be analogy an between Sept. art. 24 U.S.T. 974 jurisdic- some new crime ... and universal ("The 177 Contracting U.N.T.S. State in the subjects” purposes tion's traditional for of territory alleged of which the offender is exercising jurisdiction, criminal see 327 F.3d shall, him, found if it does not extradite be at 103-04. obliged, exception without whatsoever and

205 (as place— where takes spot the the crime op- on trading actors slaves Private the piracy in the case of it is because acts slavery gen- engaging in those posed to case of high seas and the war ju- are on eral) criminal subject to universal are of a chaotic condition or crimes because that early treaties because risdiction ” in time of irresponsible leadership war.’ interna- customary the basis formed Yousef, (quoting F.3d at 105 Willard B. akin trade considered the slave tional law Cowles, Treaty Universality Jurisdiction Over example, the 1841 to For piracy. of Crimes, 33 L.Rev. War Cal. that: provided of London Flores, (1945)); 414 F.3d at 244 see also n. Austria, of Majesties Emperor Their (“Customary international rules Bohemia, the Hungary of King humanity, against crimes in- proscribing Prussia, and of all Emperor King of crimes, cluding genocide, war have Russians, all engage prohibit to individuals against been enforceable since slaves, respec- by either their trade II.”). World War subjects, respective or their tive under belonging by capital means of flags, or Yousef, we concluded that these acts respective subjects; and to de- their to “(1) they common traits: share two are Majes- piracy. Their clare such universally by community condemned traffic any vessel further declare that ties (2) nations, by their nature occur of attempt to the Slave may carry on outside of or where either State there is alone, Trade, shall, lose all fact capable punishing, compe- no State flag. protection of their right to punish, tent the crime.” 327 F.3d at Suppression the African Treaty for I, 20, 1841, 92 Con- Trade art. Dec. Slave Non-consensual medical added), reprinted (emphasis sol. T.S. 437 “sufficiently to these is not similar” crimes M. Bassiouni & Edward in M. Cherif its into incorporation to warrant section Duty

Wise, Dedere Aut Judicare: Aut analogy. acknowledge Plaintiffs or Prosecute in International to Extradite listed 404 share that the acts in section “a (1995); Kenneth C. see also Law 132-33 quality crossing international particular In- Randall, Jurisdiction Under Universal boundaries,” argue quality Law, L.Rev. Tex. ternational experimentation shares “because (1988) (“Currently, recognize states can universal medical research of the uses of trading jurisdiction over slave universal practice physicians common and the law.”). customary Although ... we de- to crisis areas to deliver humanitari- travel principle to hold clined Yousef crossing aid.” But mere an norm, at- into ripened had give rise border does into this logically airliners fit tacks on jurisdiction over non-state ac- universal because, seas, airspace the high like class made clear where tors. We Yousef and extraterritorial. is stateless rejected jurisdiction over an we universal II, bombing accused of an criminal individual air- War universal After World Japan. leaving Philippines ac- craft jurisdiction private was extended to held, we universal many Nazi defen- 327 F.3d 103. As including tors— jurisdiction over actors is Council criminal under Control prosecuted dants which, “by acts their against only appropriate for 10—accused of crimes Law No. nature,” sovereignty. beyond are genocide war state humanity such as crimes “ Here, alleged actions oc- ... a lack Pfizer’s because, piracy, ‘there is like exclusively Nigeria, and within judicial system operating curred any adequate is not a crime experimentation committing medical cused of crimes within its ter- which, nature, incapable by ritory. its is of state The crimes listed in section 404 argument punishment. Plaintiffs’ to the are extraordinary not the exceptions be- contrary by is the state and belied federal cause singularly reprehensible are or pending civil criminal against deserving actions of condemnation. Few would Maj. Nigeria. Op. Pfizer in See at 171-72. argue piracy, for private actors may prosecuted universally be but which medical Bigio, experimentation As requires neither act of violence nor the closely more resembles the acts for which infliction of physical injury,16 is more hei- only may responsible. state actors be held nous than slavery, practices torture or compare experimenta- Plaintiffs medical made only against actionable state enti- Yet, slavery. tion with under the Restate- Rather, definition, ties. by crimes these ment, anyone may prosecuted while be where, occur in locations or during times trade, engaging slavery the slave itself when, sovereignty, and a criminal only against actionable state actors. fortiori See jurisdiction, are incapable being exer- (Third) 702(b) (“A § Restatement state vi- cised. Because if, olates international law as a matter of is entirely intra fully subject national and policy, practices, state it encourages, or jurisdiction, domestic criminal it is not ”). ... ... slavery condones Medical ex- “sufficiently similar” to those acts listed in perimentation slavery resembles in its section and cannot be incorporated by grievous exploitation of unconsenting and analogy private, as to reach non-state ac- subjects; unwilling it also resembles tor- tors. ture in physical its infliction of horrific However, pain.

emotional both the Re- defendants the Medical Case statement and recognized this Court have were not charged with conducting non- against the norm torture only reaches consensual per Rather, medical tests se. Kadic, state actors. See 70 F.3d at 243- tests, those prisoners when conducted on (Third) 44; 702(d); § Restatement see of war and members of a discrete civilian Against also Convention Torture and Oth- population imprisoned in concentration Cruel, er Degrading Inhuman or Treat- camps, constituted “war crimes” and 10, 1984, ment or Punishment art Dec. against “crimes humanity,” offenses for Treaty 100-20, S. Doc. No. 1465 U.N.T.S. which customary international law has im- (“CAT”) (defining being torture as “in- posed individual responsibility. See flicted instigation or of or with Flores, 414 F.3d at 244 n. 18. Unlike the acquiescence consent or of a public action, Defendant in this the Nazi doctors official or person other acting an official convicted the American military tribu- capacity.”).15 nal were actors. Each convict-

One of the fundamental attributes of ed position defendant held a authority sovereignty is a authority state’s to exer- either the medical military services or the jurisdiction cise criminal persons over ac- of the Third Reich.17 See 1 Trials War It should be noted that while (stating universal U.N.T.S. 15. piracy may consist of jurisdiction criminal detention, under "any illegal the CATdoes exist acts of violence or torturers, must, those torturers depredation....”) defini- act of tion, be state actors. See CAT arts. 17. All but three of the 23 defendants were See, e.g., United Nations Convention on the doctors. 1 Trials War Criminals 29. The VII, Law part of the Sea art. Dec. three that were not were colonels or senior 103-39, Treaty S. Doc. No. colonels in the Nazi 1SS. Trials War Crimi- Moreover, enough gain the atrocities for entrance into the “law of 29. Criminals only nations.” The norm must not they convicted victimized state be were universal, it must touch on matters that concentra- prisoners state-administered Indictment, mutual, several, merely are “of and not camps, according to the tion Filartiga, at of the German Armed concern.” 630 F.2d “for the benefit mutual they 11-14. It is difficult to Matters are of concern when Forces.” Id. at example relationship between imagine egregious “affectf] a more states an individual a customary foreign of a international law between violation state, appropriate a more case for ATS used those states for [are] norm or good dealings their common inter jurisdiction. and/or IIT, se.” 519 F.2d at 1015. On the оther majority today The authorizes the exer- hand, matters of several concern are those entirely jurisdiction of ATS over an cise separately “in which are States inde- corporation violating previ- a private Flores, pendently interested.” ously unrecognized norm of international Flores, example, 249. For as we noted so, doing my colleagues accept law. private by another, party “murder of one than in other case proof far weaker universally proscribed by the domestic law this has identified norm where Court of all countries ... actionable under law, and, customary appar- violation of in- [ATS] ently, purported overlook the fact this ternational law because ‘the nations of the few way norm in no resembles those world’ have not demonstrated that against enforceable entities. norms mutual, wrong merely is of and not sever- Supreme tasked Court with When al, (quotation concern.” Id. marks omit- doorkeeping” to ensure that the “vigilant ted). majority The concludes that non- international norms re- list of actionable experimentation by consensual medical one Sosa, “narrow,” mains U.S. on private party another is a matter of demanding be no less S.Ct. we must mutual I disagree. concern. past. have been in the than we Under standard, put the evidence forward consistently We have held that the best a norm of Plaintiffs does not establish evidence that states consider a matter to customary international law actionable mutual concern is fact that be of against private actors. I believe that the agreed “by have to be bound means of majority’s departs from our set- decision express Filartiga, international accords.” considerably our tled case law and lowers 888; Flores, 630 F.2d at see 414 F.3d at jurisdiction. previously high bar for ATS Khulumani, 249; at 274 n. 7 (Katzmann, J., concurring). majority Mutuality II. ICCPR, points to the Convention Biomedicine, many principles Rights There are on which Human and the community agree. of the world 2001 Clinical Trial Directive as evidence most states support throughout Most find and enforcement “States world have ... richly legal systems place express binding diverse entered into inter- accep- agreements prohibiting But national noncon- globe. around the universal principle experimentation.” tance as a normative is not sensual medical See doctors, diseases, acquit- the 20 all but one ist in skin and venereal was nals Of positions "held in the medical services of the charges. War ted of all 1 Trials Criminals Third Reich.” 1 Trials War Criminals 29. 10; 2 Trials War Criminals 292-94. exception, Pokorny, special- The lone Adolf Maj. agreements at But those it Op. concern, to be a matter of mutual it mutuality fail must consequences “threaten!] to demonstrate the same serious Sosa, international affairs.” reason fail to demonstrate universali- 542 U.S. at 715, 124 Supreme S.Ct. 2739. The ty not address Court ICCPR does acts —the listed three mutual wrongs historical non-state actors and the other two were guideposts to frame this inquiry: infringe alleged not in at the time of force rights ambassadors, ment of the international misconduct. Whatever con- violation of piracy. safe conducts and been reached as to sensus has non-consen- at 124 S.Ct. 2739. An assault sual against an “impinged ambassador upon the yet expression actors has not “found sovereignty of the foreign nation and if not accords,” numerous treaties and Filar- of. adequately redressed could rise to an issue tiga, majority 883. The cites of war.” Id. at 124 S.Ct. 2739. The worldwide, multi-continental, no universal- century 18th safe-conduct document was ly applicable Against “Convention Medical the historical equivalent of the modern because, Experimentation,” the mo- passport, “which entitles bearer with a ment, none exists. That fact alone distin- to, within, valid visa passage to safe and guishes case from Filartiga, Amerada out foreign pursuant of a treaty land to a Hess, and Kadic. agreement or an negotiated by his or her In the a binding global absence of trea- sovereign and the host sovereign.” Taver ty, majority seeks to demonstrate mu- Taveraz, (6th as v. All F.3d Cir. tuality by describing of concern the down- 2007) (quoting Lee, Thomas H. The Safe- stream effects of non-consensual medical Statute, Conduct Theory the Alien Tort essence, experimentation. In majority (2006)). 106 Colum. Thus, L.Rev. contends that non-consensual medical ex- “the purpose of the doctrine of safe con periments feed among distrust their vic- ducts under the protect law of nations is to tims, which, turn, engenders a general safety security and person reluctance to seek future medical attention property journeying bearing alien vaccination, which, turn, helps accel- (and the safe conduct privilege consequent erate spread of infectious diseases ly preserve commercial diplomatic across Maj. Op. international borders. See relationships between the alien’s host and Indeed, at 186-87. I would concede that countries).” home Id. at 773-74. This is majority may quite right. be But a today still true passport issued —a smaller, more interdependent world com- United States contains an official request munity has not been employed by the Su- from the Secretary of an authority State to (or preme my Court other court to of another sovereign state: Secretary “The knowledge) to convert claims as those such of State of the United States of America presented here into violations of the law of hereby requests all may whom it concern fact, nations. the majority’s theory permit of the United citizen/national would be no different when evaluating the States named pass herein to without delay medical malpractice of Pfizer’s research or hindrance and in give case of need to all physicians products or the strict liability lawful aid protection.” Breaches of allegedly for its drug, defective but mal- customary impair practice products liability among are normal expectations that nations have in quintessential subjects of domestic law. dealing with other They nations. must

It is not enough that a wrong could consequences threaten serious in interna ramifications; create international were, order tional affairs because the norms mutual concern. Id. at a matter of formal not for states’ are, the foundation still 243-44. one another. relationships with a matter Demonstrating wrong with the that a squarely fit

Piracy does not necessarily be dif- but concern must paradigms, of mutual historical two Sosa other only posed by Court has Supreme affairs ficult. The to international threat jurisdiction for ATS over exegesis. Suffice the door оpened no detailed needs piracy Republic’s violations of the law of young “narrow set of that one of say it to remedy campaign nations, judicial admitting was its military tests first see, Pirates, threatening Act serious e.g., same time Barbary and at the against and in international affairs.” consequences of the Commerce Protection For the Sosa, Against S.Ct. the United States 542 U.S. Seamen IV, 2, 2 Cruisers, yet § Stat. the world have not ch. The nations of Tripolitan (1802) Jef- medical (authorizing President that non-consensual demonstrated by forces to actors “is of experimentation the armed non-state to instruct ferson vessels, several, concern, goods mutual, merely of all and not prize and make “seize Bey Tripoli ac- effects, express international belonging by means all Filartiga, to be done such F.2d at 888. Nor also to cause cords.” ... and hostility as the consequences or threaten serious precaution acts of does it other may, in his manner justify, and affairs in the same of war will international state continues to the historical require.”), piracy to the same extent as opinion, or in interna- consequences Supreme listed Court paradigms serious threaten ¶ 1851, 2, counterparts Res. identified today, affairs see S.C. their modern tional 2008) (Dec. 16, showing, I Without either Doc. this Court. U.N. S/RES/1851 part actively majority that non- agree “to take with the (calling upon states cannot rob- experimentation by and armed medical fight against piracy consensual Somalia”). coast of a matter of mutual con- bery private at sea off the actors is cern. showing in no lesser accepted haveWe by geno- posed threat case law. The

our Action III. State empowered that states are great cide is so The fact that medical organs of the competent “the request subject not a of cus- by private actors is action under Nations to take such United law does not end the tomary international of the United Nations the Charter supports If inquiry. prevention appropriate for consider liability, a liability not state but genocide.” acts of suppression of if may still be liable he or she private actor and Punish- on the Prevention Convention In that re- under color of law.” art. Dec. “acted of Genocide of the Crime ment employ told to our U.S.C. gard, we are 78 U.N.T.S. 102 Stat. jurisprudence inquiry. in the See § 1983 collectively estab- Conventions The Geneva Kadic, 448; 70 F.3d at F.3d at Bigio, lish, contracting parties obligate matter, requires As an initial follow, by defini- 245. laws of war—almost includes a norm of nations the law affairs. See a matter of international tion states, which, in- against Kadic, the other actionable at 242-43. On case, But even is far from certain. stant hand, law does because international sake, that inter- argument’s assuming, for by private to include acts define torture from conduct- states prohibits national law entities, ac- conduct non-state torturous tests, Plaintiffs domestically ing non-consensual criminalized tors—while —is that Pfizer acted not actionable have not demonstrated under the law of nations. Court, appeal of law. Id. at *18. On to this under the color both parties addressed the issue of state action procedural requires This issue bit in their majority briefs. The concludes 2002, Pfizer moved to dismiss context. In allegations Plaintiffs’ of state action complaint Plaintiffs’ in Abdullahi on the were sufficient to defeat a motion to dis- (1) alleged Plaintiffs had not grounds that Maj. atOp. miss. See 187-88. I cannot (2) actor, that Pfizer was a state agree. of forum non conveniens. ground alternate twin complaints, their which total 628 Inc., Pfizer, v. No. 01 Civ. See Abdullahi paragraphs, only Plaintiffs make four alle- (S.D.N.Y. 8118, 31082956, at *12 2002 WL gations concerning Nigerian the role of the 2002). 17, Pauley Sept. Judge granted the government experiments: the Trovan motion, forum non conveniens but denied (1) in order for FDA the to authorize the motion, the that concluding state action export Trovan, “Pfizer obtained the re- “sufficiently allege[d] Plaintiffs that the quired letter of request Nigerian from the Nigerian government former and Pfizer (2) government”; government the “ar- joint participants were the Trovan treat- rang[ed] for Pfizer’s accommodation in appealed ment.” Id. at *6. Plaintiffs (3) Kano”; the government acted “to si- dismissal, district court’s and Pfizer cross- Nigerian physicians lence critical of [Pfiz- appealed from the court’s denial of its test”; (4) government er’s] “as- motion to dismiss on state action. See signed] Nigerian physicians to assist in Inc., Pfizer, Abdullahi v. 77 Fed.Appx. 48 project.”18 Elsewhere in their com- (2d Cir.2003). appeal, On we vacated plaints, eonclusory Plaintiffs note in fash- dismissal, judgment district court’s Nigerian ion that a publicly doctor did not cross-appeal, did not reach Pfizer’s noting object study to the Trovan because it that our intervening decision in Flores “seemed to have the backing Niger- of the might application have some on remand. government.” ian Judge Pauley, 53. Back before Pfiz- dismiss, er filed a new motion arguing Court, In their brief to this Plaintiffs that Plaintiffs failed to a claim state under seek to complaints by bolster their de- substantially different ATS landscape scribing the “Nigerian government role of which now included Supreme Court’s allegedly doctors” at government- decision in Sosa and our decision in hospital Flores. owned study. hosted the Inc., Pfizer, However, See Abdullahi v. No. 01 portions Civ. complaints (S.D.N.Y. 8118, 2005 WL they *3 support cite do not their conten- 2005). Aug. Both of these decisions tions. complaints Nowhere their did identity made clear that the was, of the defen- allege hospital Plaintiffs that the fact, dant is a component critical a government administered, whether owned or principle is a norm of customary they interna- nor allege did that the four Nigerian tional Without addressing law. or affirm- working doctors with Pfizer were em- ing previous its finding ployed conclusion suffi- government, and our review action, allegations cient of state the district a grant of decision to a motion to dismiss granted court dismiss, Pfizer’s motion to “is limited to the facts as asserted within holding that was the four corners of complaint” initially allege gov- Plaintiffs by "Nigerian physician also that the created a whom Pfizer ernment approval backdated a letter of for the says principal investigator.” was its test, allege but then that the letter was in fact McCarthy v. Dun Nigerian government requested attached documents. & the import (2d Corp., arranged Bradstreet of Trovan and for Pfizer’s accom- .2007). Kano, modations and some medical staff in Cir allege government do not that the or allegations plainly are These bare insuf any government employee played any role ficient to survive motion dismiss in either administering Trovan without Supreme lack of state action. The Court’s deciding consent to do so the first hardly law on state action is a model case Supreme instance. The Court has de- clarity, principles but certain are well- scribed “the typical raising case state- matter, settled. As threshold the con action issue” as one in which “a private state must alleged duct attributable party step has taken the decisive requisite specificity. be defined with the plaintiff, caused the harm to the and the analyzing allegations of state ac “When question is whether the State was suffi- tion, begin ‘by identifying specific we ” ciently involved to treat decisive con- plaintiff complains,’ of which the conduct duct as state action.” NCAA v. Tarkani- Co., v. Metro. Ins. Tancredi Life an, 488 U.S. 109 S.Ct. (2d Cir.2003) (quoting Am. Mfrs. (1988). L.Ed.2d 469 Plaintiffs have not Sullivan, Ins. Co. v. 526 U.S. Mut. alleged any facts that would indicate that 977, (1999)), 143 L.Ed.2d 130 119 S.Ct. “yes.” the answer here is cases, a of state action finding most premised the fact that upon complaints “must be the Plaintiffs’ are more notewor- ” specific that responsible thy they allege State is con for what do not than what do; Ass’n, duct, Westport Library they They suggested Horvath v. have not (2d Cir.2004) (internal 147, 154 Pfizer was exercising any delegated 362 state omitted). Atkins, Determining authority, 42, ac quotation state West v. 487 U.S. cf. 2250, (1988), “requires tracing tion these cases 108 S.Ct. 101 L.Ed.2d 40 or if that activity Nigerian government to its source to see source that the “knowingly fairly accepted] can be said to the state.” Leshko be the benefits derived from [the (3d Servis, 337, Cir.2005); behavior,” Tarkanian, v. 423 F.3d 340 unlawful] 488 U.S. 192, Hadges Racing Corp., see also v. Yonkers at 109 454. S.Ct. Plaintiffs have not (2d Cir.1990). 1079, alleged conspired govern- 918 F.2d 1082-83 As that Pfizer stated, recently deprive subjects we when confronted with a ment officials to dismiss, Barnes, enough rights, motion to it “is not ... for their Fries v. 618 F.2d cf. (2d Cir.1980), plaintiff plead to state they involvement nor have al- activity alleged institution leged Nigerian government some that the exer- injury upon plaintiff; Pfizer, have inflicted rath power cised coercive over cf. er, plaintiff allege Secondary must the state Brentwood Acad. v. Tenn. Sch. Ass’n, activity was involved with the that caused Athletic 531 U.S. 121 S.Ct. (2001). injury giving Sy fact, rise to the action.” 148 L.Ed.2d In Indep. Group Living balski v. Home Pro allege any Nigerian Plaintiffs did not Inc., (2d gram, government 546 F.3d 257-58 Cir. officials knew about even 2008) (internal omitted). tests, quotations non-consensual if Nigerian because government doctors were somehow in- Here, not, activity was as the ma- study, volved in the spec- Plaintiffs did not concludes, jority apparently conducting the role, ify if any, they played. what in general, Trovan trials but rather admin- istering drug Freeport-McMo- without informed con- The case of v. Beanal Inc., Ran, Although allege (E.D.La.1997), sent. that the F.Supp. Plaintiffs (5th Cir.1999), question in answered that in the affirmative 197 F.3d aff'd Beanal, Horvath, plaintiffs seeking to half of putatively where structive. sought the ATS to establish private ap- recover under defendant’s trustees were state of the Indonesian on the basis But pointees. state action 153. the assistance in allegedly action military’s involvement alleged by helping procure Plaintiffs — rejected court that ar able conduct. in a hospital arranging ward for the plaintiffs had not “al holding that gument, of a handful of assistance doctors—is military personnel leged whether enough clear this Using gov- hurdle. Freeport’s policies or mere helped enforce staff, property, government ernment violative conduct.” Id. ly ... оbserved government even funds does not make a conclusory statements of Broad entity a state actor when its deci- are not sufficient to es state involvement independently are made of the state. sions action; “there must be some tablish state Lexington, See Yeo v. Town indicating troops jointly that the allegation (1st Cir.1997) banc). (en 241, 254 conduct, jointly partici in the cooperated (un- generalized Plaintiffs’ allegations conduct, influenced pated in the the con supported by allegations) factual that the part played integral duct or government acted to silence critics rights.” human Id. at deprivation of helpful. They test are no more do not allega true here.19 Plaintiffs’ The same is allege government who these officials inadequate. tions are were, critics, how acted to silence alleging that Even without State sequence when in the of events this con- encouraged” “coerced or even the act com- “merely conclusory duct occurred. Such a of, plained Plaintiffs can still survive a allegation private entity that a acted in if motion to dismiss “the relevant facts concert with a state actor does not suffice point entwinement to the pervasive show § to state a claim against private largely overlapping identity between the Nassau, entity.” County Ciambriello v. entity plaintiff con- State and the (2d Cir.2002). Horvath, actor.” tends is state most, At complaints alleged Plaintiffs’ omitted). (quotation at 154 This line of Nigerian government acquiesced around the relationship cases revolves be- approved program to or the Trovan actor, opposed tween state as general without knowing disturbing its de- Showing act. specific “overlapping approved program tails. That it uncommon, is identity” highly is and most hardly surprising the midst of a wide- private often where a actor is per- arises —in spread epidemic, Nigerian government forming one of the few functions tradition- likely help every welcomed ally exclusively entity from reserved to the state “[mjere it, entity. offering approval or but ac- is controlled a state State quiescence assistance itself is insufficient —the rel- the initiatives of a question evant party justify holding is whether the decision- is not sufficient to ostensibly responsible makers were state actors. We State those initiatives.” line, upon by government retaliating 19. The case relied the district court with the Burmese entirely distinguishable. Nat’l See Coal. against protesters military action and Inc., Unocal, Gov't the Union Burma v. imposed by military forced labor the Burmese (C.D.Cal.1997). There, plain- 176 F.R.D. 329 There, knowledge. with Unocal’s Id. at 348. by alleging tiffs survived a motion to dismiss here, opposed the state committed the government that Unocal and the Burmese unlawful acts. joint partners pipe- were venturers and in a 991, 1004-05, Yaretsky, 457 U.S. v. Blum ASTENJOHNSON, INC., Appellant (1982). L.Ed.2d 534

102 S.Ct. that Pfiz- have not demonstrated Plaintiffs v. the color of law” such “under er acted COMPANY; CASUALTY COLUMBIA Nigerian gov- for the held liable it can be Company. American Insurance “law of alleged violation ernment’s nations.” No. 07-2305. Appeals, States Court of

United Third Circuit. pic- allegations paint a vivid Plaintiffs’ Argued Oct. suffering pain unspeakable

ture of 2, 2009. Opinion April Filed: children. The issue of innocent of dozens however, is not ‍​​‌‌‌‌​​​‌​‌​​‌​​‌​​‌‌​​​‌​‌‌​​​‌​​​​‌‌‌​​‌​‌​​‌‍whether appeal, “wrong,” or alleged conduct was Pfizer’s actionable, but legally it is whether

even within both the “narrow it falls

whether norms for which of international

class” exists, the even jurisdiction

ATS actionable of those norms

smaller subset actors. Our Court and

against non-state pellucidly have made it Supreme Court jurisdiction must be re-

clear that ATS only acts that the nations of the

served collectively determine interfere with

world relations with one another—

their formal by private acts indi-

including those rare as to threaten

viduals that are so serious very peaceful fabric of my colleagues agree I cannot

affairs. poses the alleged

that Pfizer’s conduct universally and inter- threat or is so

same fit within that

nationally proscribed as to

narrow class.

I dissent. respectfully

Case Details

Case Name: Abdullahi v. Pfizer, Inc.

Court Name: Court of Appeals for the Second Circuit

Date Published: Jan 30, 2009

Citation: 562 F.3d 163

Docket Number: Docket 05-4863-cv(L), 05-6768-cv(CON)

Court Abbreviation: 2d Cir.