Abdullahi v. Pfizer Inc
Abdullahi v. Pfizer Inc
PFIZER INC
Rabi ABDULLAHI, individually and as the natural guardian and personal representative of the estate of
her daughter Lubabatau Abdullahi, Salisu Abullahi, individually and as the natural guardian and personal
representative of the estate of his son Abulliahi [Manufi] Salisu, Alasan Abdullahi, individually and as the
natural guardian and personal representative of the estate of his daughter Firdausi Abdullahi, Ali
Hashimu, individually and as the natural guardian and personal representative of the estate of his
daughter Suleiman, Muhammadu Inuwa, individually and as the natural guardian and personal
representative of the estate of his son Abdullahi M. Inuwa, Magaji Alh Laden, individually and as the
natural guardian and personal representative of the estate of his son Kabiru Isyaku, Alhaji Mustapha,
individually and as the natural guardian and personal representative of the estate of his daughter
Asma'u Mustapha, Suleiman Umar, individually and as the natural guardian and personal representative
of the estate of his son Buhari Suleiman, Zainab Abdu, a minor, by her mother and natural guardian,
Haja Abdullahi, Haji Abdullahi, individually, Firdausi Abdullahi, a minor, by her father and natural
guardian Abdullahi Madawaki, Abdullahi Madawaki, individually, Sani Abdullahi, a minor, by his father
and natural guardian, Sani Abdullahi, Abdullahi Ado, a minor, by his mother and natural guardian, Aisha
Ado, Aisha Ado, individually, Abdumajid Ali, a minor, by his father and natural guardian, Alhaji Yusuf Ali,
Nura Muhammad Ali, a minor, by his father and natural guardian, Muhammad Ali, Muhammad Ali,
individually, Umar Badamasi, a minor, by his father and natural guardian, malam Badamasi Zubairu,
Malam Badamasi Zubairu, individually, Muhammadu Fatahu Danladi, a minor, by his father and natural
guardian, Alhaji Danladi Ibrahim, Alhaji Danaldi Ibrahim, individually, Dalha Hamza, a minor, by his
father and natural guardian malam Hamza Gwammaja, Malam Gwammaja, individually, Tasiu Haruna, a
minor, by his guardian Mukhtar Saleh, Mukhtar Saleh, individually, Muhyiddeen Haasan, a minor, by his
father and natural guardian, Tijjani Hassan, Tijjani Hassan, individually, Kawu Adamu Ibrahim, a minor,
by his father and natural guardian, Malam Abamus Ibrahim Adamu, Alhaji Ibrahim Haruna, individually,
Mallam Idris, individually, Yusuf Idris, a minor, by his father and naturall guardian, Idris Umar, Idris
Umar, individually, Hafsat Isa, a minor, by her father and natural guardian, Isa Muhammed Isa, Isa
Muhammed Isa, individually, Taju Isa, a minor, by her father and natural guardian, Malam Isa Usman,
Malam Isa Usman, individually, Hadiza Isyaku, a minor, by her father and natural guardian, Isyaki
Shuaibu, Isyaku Shuaibu, individually, Zahra'u Jafaru, a minor, by her father and antural guardian, Jafru
Baba, Jafaru Baba, individually, Anas Mohammed, a minor, by his father and natural guardian, Malam
Mohammed, Malam Mohammed, individually, Nafisatu Muhammed, a minor, by her mother and
natural guardian, Yahawasu Muhammed, Yahawasu Muhammed, individually, Muhsinu Tijjani, a minor,
by his father and natural guardian, Tijjani Hassan, Alhaji Yusuf Ali, Maryam Idris, a minor, by her father
and natural guardian, Malam Idris, Ajudu Ismaila Adamu, individually and as parent and natural guardian
of Yahaya Ismaica, minor, Malam Mohammed, individually and as parent and natural guardian of Bashir
Mohammed, minor, Malam Yusab Ya'u Amale, individually and as parent and natural guardian of Suyudi
Yusals Yu'a, minor, Malasm Haruna Adamu, individually and as parent and natural guardian of
Mohammed Tasi'u Haruna, minor, Zangon Kwajalawa, individually and as parent and natural guardian of
Nuruddim Dauda, minor, Malam Dahauru Ya'y, individually and as parent and natural guardian of Rabi
Dahuru, minor and as parent and natural guardian of Zainab Musa Dahuru, minor, Zangon Marikita,
individually and as parent and natural guardian of Ismaila Musa, minor, Arhaji Muihammad Soja,
individually and as parent and natural guardian and personal representative of Estate of Hamaza Achaji
Muhammad, minor, deceased, Achaji Ibrahim Dankwalba, individually and as parent and natural
guardian of Personal Representative of Est of Abdullahi Ibrahim, minor, Mallam Lawan, individually and
as parent and natural guardian and personal representative of Est. of Aisha Lawan, minor, deceased,
Alhaji Muhammed Tsohon Sojo, individually and as parent and natural guardian and personal
representative of Est. of Unni Alhasi Muhammed, minor, Ismaila Zubairui, individually and as parent and
natural guardian and personal representative of Est. of Mustapha Zubairu, minor, Deceased, Abubaker
Musa, individually and as parent and natural of Sa'adatu Musa, Minor, Mohamed Abdu, individually and
as parent and natural guardian of Haruna Abdu, minor, Mallam Hassan, individually and as parent and
natural guardian and personal representative of Est. of Sadiya Hassan, minor, deceased, Mallam Yakubu
Umar, individually and as parent and natural guardian of, Mallam Samaila, individually and as parent and
natural guardian of Adamu Samalia, minor, Musa Yahaya, individually and as parent and natural
guardian of Ukhasa Musa, minor, Audu Ismailia Adamu, individually and as parent and natural guardian
of Yashaya Samaila, Malam Musa Dahiru, individually and as parent, Malam Musa Zango, individually
and as parent and natural guardian os Samaila Musa, minor, Mallam Alhassan Maihula, individually and
as a parent and natural guardian of Najib Maihula, minor, Mallam Abdullah Gama, individually and as
parent and natural guardian of Dankuma Gama, Minor, Dauda Nuhu, individually and as parent and
natural guardian and personal representative of Est. of Hamisu Nuhu, minor, deceased, Mallam
Abdullahi, individually and as parent and natural guardian and personal representative of Est. of
Najaratu Adbullahi, minor, deceased, Malam Umaru Mohammed, individually and as parent and natural
guardian and personal representative of Est. of Sule Mohammed, minor, deceased, Mallam Nasiru,
individually and as parent and natural guardian and personal representative of Est. of Yusif Nasiru,
minor, deceased, Yusuf Musa, individually and as parent and natural guardian and personal
representative of Est. of Nafisatu Musa, minor, deceased, Mallam Muritala, individually and as parent
and natural guardian and personal representative of Est. of Umaru Muritala, minor, deceased, Mallam
Tanko, individually and as parent and natural guardian and personal representative of Est. of madina
Tankol, minor deceased, Mallam Sheu, individually and as parent and natural guardian and personal
representative of Est. of Madina Tankol, minor, deceased, Malam Kabiru Mohamed, individually and as
parent and natural guardian and personal representative of Est. of Kabiru Mohamed, minor, deceased,
Mallam Sule Abubakar, individually and as parent and natural guardian and personal representative of
Est. of Fatima Abubaker, minor, deceased, Mallam Idris, individually and as parent and natural guardian
and personal representative of Est. of Baba Idris, minor, deceased, Mallam Mohamed Bashir,
individually and as parent and natural guardian and personal representative of Est. of Sani Bashir, minor,
deceased, Ibrahim, individually and as parent and natural guardian and personal representative of Est.
Hassan Ibrahim, minor, deceased, Alhaji Shuaibu, individually and as parent and natural guardian and
personal representative of Est. of Masjbatu Shuaibu, minor, deceased, Mallam Abdullahi Sale,
individually and as parent and natural guardian and personal representative of Est. of Shamisiya Sale,
minor, deceased, Mallam Ibrahim Amyarawa, individually and as parent and natural guardian and
personal representative of Est. of Yahaya Ibrahim, minor, deceased, Mallam Abdu Abubaker, individually
and as parent and natural guardian and personal representative of Est. of Nasitu Abubaker, minor,
deceased, Mallam Yusuf, individually and as parent and natural guardian and personal representative of
Est. of Hodiza Yusuf, minor, deceased, Mallam Dauda Yusuf, individually and as parent and natural
guardian and personal representative of Est. of Abubaker Sheu, minor, deceased, Maliam Mohammed
Sheu, individually and as parent and natural guardian and personal representative of Est. of Mustapha
Yakubu, minor, deceased, Alhaji Ubah, individually and as parent and natural guardian and personal
representative of Est. of Maryam Ubah, minor, deceased, Mallam Mohamadu Jabbo, individually and as
parent and natural guardian of Auwalu Mohamadu, Mallam Abdullah Adamu, individually and as parent
and natural guardian and personal representative of Est. of Abdullah Adamu, minor, Plaintiffs-
Appellants, v. PFIZER, INC., Defendant-Appellee.
Before: POOLER, B.D. PARKER, and WESLEY, Circuit Judges. Peter Safirstein (Elaine S. Kusel, Ann M.
Lipton, Andrew Wilmar, and Tatiana Rodriguez, on the brief), Milberg Weiss Bershad & Schulman LLP,
New York, NY, for Plaintiffs-Appellants Rabi Abdullahi, et al. Richard Altschuler (Ali Ahmad, Cheverly,
MD, on the brief), Altschuler & Altschuler, West Haven, CT, for Plaintiffs-Appellants Ajudu Ismaila
Adamu, et al. Steven Glickstein (David Klingsberg, Maris Veidemanis, James D. Herschlein, and Julie B. du
Pont, on the brief), Kaye Scholer LLP, New York, NY, for Defendant-Appellee Pfizer, Inc.
This consolidated appeal is from the judgments of the United States District Court for the Southern
District of New York (Pauley, J.) dismissing two complaints for lack of subject matter jurisdiction under
the Alien Tort Statute, 28 U.S.C. § 1350 (“ATS”), and in the alternative, on the ground of forum non
conveniens. Plaintiffs-Appellants Rabi Abdullahi and other Nigerian children and their guardians sued
Defendant-Appellee Pfizer, Inc. under the ATS (“the Abdullahi action”). They alleged that Pfizer
violated a customary international law norm prohibiting involuntary medical experimentation on
humans when it tested an experimental antibiotic on children in Nigeria, including themselves, without
their consent or knowledge. Plaintiffs-Appellants Ajudu Ismaila Adamu and others, also children and
their guardians who were part of Pfizer's Nigerian drug experiment, brought a similar action against
Pfizer, alleging violations of the ATS, the Connecticut Unfair Trade Practices Act (“CUTPA”), and the
Connecticut Products Liability Act (“CPLA”) (“the Adamu action”). Pfizer moved to dismiss both actions
for lack of subject matter jurisdiction and on the basis of forum non coveniens. The district court
granted the motions and both sets of plaintiffs have appealed.
As explained below, we conclude: (1) that the district court incorrectly determined that the prohibition
in customary international law against nonconsensual human medical experimentation cannot be
enforced through the ATS; (2) that changed circumstances in Nigeria since the filing of this appeal
require re-examination of the appropriate forum, albeit on the basis of a legal analysis different from
that employed by the district court; and (3) that the district court incorrectly applied Connecticut's
choice of law rules in the Adamu action. Consequently, we reverse and remand the cases to the
district court for further proceedings.
BACKGROUND
On review of a district court's grant of a motion to dismiss, we assume as true the facts alleged in the
complaints, construing them in the light most favorable to the appellants. See Vietnam Ass'n for
Victims of Agent Orange v. Dow Chem. Co., 517 F.3d 104, 115 (2d Cir.2008). The central events at issue
in these cases took place in 1996, during an epidemic of bacterial meningitis in northern Nigeria.1 The
appellants allege that at that time, Pfizer, the world's largest pharmaceutical corporation, sought to gain
the approval of the U.S. Food and Drug Administration (“FDA”) for the use on children of its new
antibiotic, Trovafloxacin Mesylate, marketed as “Trovan.” They contend that in April 1996, Pfizer,
dispatched three of its American physicians to work with four Nigerian doctors to experiment with
Trovan on children who were patients in Nigeria's Infectious Disease Hospital (“IDH”) in Kano, Nigeria.
Working in concert with Nigerian government officials, the team allegedly recruited two hundred sick
children who sought treatment at the IDH and gave half of the children Trovan and the other half
Ceftriaxone, an FDA-approved antibiotic the safety and efficacy of which was well-established.
Appellants contend that Pfizer knew that Trovan had never previously been tested on children in the
form being used and that animal tests showed that Trovan had life-threatening side effects, including
joint disease, abnormal cartilage growth, liver damage, and a degenerative bone condition. Pfizer
purportedly gave the children who were in the Ceftriaxone control group a deliberately low dose in
order to misrepresent the effectiveness of Trovan in relation to Ceftriaxone. After approximately two
weeks, Pfizer allegedly concluded the experiment and left without administering follow-up care.
According to the appellants, the tests caused the deaths of eleven children, five of whom had taken
Trovan and six of whom had taken the lowered dose of Ceftriaxone, and left many others blind, deaf,
paralyzed, or brain-damaged.
Appellants claim that Pfizer, working in partnership with the Nigerian government, failed to secure the
informed consent of either the children or their guardians and specifically failed to disclose or explain
the experimental nature of the study or the serious risks involved. Although the treatment protocol
required the researchers to offer or read the subjects documents requesting and facilitating their
informed consent, this was allegedly not done in either English or the subjects' native language of
Hausa. The appellants also contend that Pfizer deviated from its treatment protocol by not alerting the
children or their guardians to the side effects of Trovan or other risks of the experiment, not providing
them with the option of choosing alternative treatment, and not informing them that the non-
governmental organization Médecins Sans Frontières (Doctors Without Borders) was providing a
conventional and effective treatment for bacterial meningitis, free of charge, at the same site.2
The appellants allege that, in an effort to rapidly secure FDA approval, Pfizer hastily assembled its test
protocol at its research headquarters in Groton, Connecticut, and requested and received permission to
proceed from the Nigerian government in March 1996. At the time, Pfizer also claimed to have
secured approval from an IDH ethics committee. Appellants allege, however, that the March 1996
approval letter was backdated by Nigerian officials working at the government hospital well after the
experiments had taken place and that at the time the letter was purportedly written, the IDH had no
ethics committee.3 Appellants also contend that the experiments were condemned by doctors,
including one on Pfizer's staff at the time of the Kano trial.
In 1998, the FDA approved Trovan for use on adult patients only. After reports of liver failure in
patients who took Trovan, its use in America was eventually restricted to adult emergency care. In
1999, the European Union banned its use.
In August 2001, the Abdullahi plaintiffs sued Pfizer under the ATS, alleging that the experiments violated
international law. In September 2002, the district court granted Pfizer's motion to dismiss the
Abdullahi claims on the ground of forum non conveniens, conditioned on Pfizer's consent to litigation in
Nigeria. Abdullahi v. Pfizer, Inc., No. 01 Civ. 8118(WHP), 2002 WL 31082956, at *12 (S.D.N.Y. Sept. 17,
2002) (“Abdullahi I ”). It found that Nigeria was an adequate alternative forum despite plaintiffs'
contentions about corruption in the Nigerian court system. Id. at *8-10. The district court denied
Pfizer's motion to dismiss under Rule 12(b)(6), Fed.R.Civ.P., concluding that the plaintiffs adequately
alleged that Pfizer's collusion with the Nigerian government made it a state actor. Id. at *5-6.
Meanwhile, another group of children and guardians involved in the Trovan experiment sued in the
Federal High Court in Kano, alleging claims under Nigerian law. That case, Zango v. Pfizer International,
Inc., [2001] Suit No. FHC/K/CS/204/2001 (Nigeria), was dismissed in 2003 after plaintiffs voluntarily
discontinued the suit following the removal from the bench of the first judge assigned to the action and
the second judge's decision to decline jurisdiction for personal reasons. Abdullahi v. Pfizer, Inc., No. 01
Civ. 8118(WHP), 2005 WL 1870811, at *5 (S.D.N.Y. Aug. 9, 2005) (“Abdullahi III ”). On appeal to this
Court from the district court's dismissal in Abdullahi I, the Abdullahi appellants argued that the dismissal
of the Zango litigation was a result of rampant corruption, which indicated that the Nigerian judicial
system could not provide an adequate alternative forum for their action. Given an inconclusive record
regarding the events leading to the dismissal of the Zango lawsuit, we vacated the judgment and
remanded for further fact-finding on forum non conveniens. See Abdullahi v. Pfizer, Inc., 77 Fed.Appx.
48, 53 (2d Cir.2003) (summary order) (“Abdullahi II ”).
In November 2002, following the dismissal of the Zango lawsuit, a number of the Zango plaintiffs filed
the Adamu action. They alleged that in planning the Trovan experiment in Connecticut and in
conducting the tests in Nigeria without informed consent, Pfizer violated the CUTPA, the CPLA, and the
ATS. Eventually, the Adamu action was transferred to the Southern District of New York and
consolidated with the Abdullahi action. Pfizer then moved to dismiss both cases for failure to state a
claim under the ATS and on the basis of forum non conveniens. It also moved to dismiss in Adamu on
the ground that Connecticut choice of law principles require the application of Nigerian law, which bars
suit under CUTPA and the CPLA.
The district court granted the motions. See Abdullahi III, 2005 WL 1870811; Adamu v. Pfizer, Inc., 399
F.Supp.2d 495 (S.D.N.Y.2005). In Abdullahi III, Judge Pauley held that while “[p]laintiffs correctly state
that non-consensual medical experimentation violates the law of nations and, therefore, the laws of the
United States,” they failed to identify a source of international law that “provide[s] a proper predicate
for jurisdiction under the ATS.” 2005 WL 1870811, at *9, 14. Noting that “a decision to create a private
right of action is one better left to legislative judgment in the great majority of cases,” he concluded that
“[a] cause of action for Pfizer's failure to get any consent, informed or otherwise, before performing
medical experiments on the subject children would expand customary international law far beyond that
contemplated by the ATS.” Id. at *13-14 (internal quotation marks omitted).
With regard to the forum non conveniens analysis, the district court declined to accept plaintiffs'
submissions concerning Pfizer's alleged bribery of Nigerian officials on the ground that they were not
based on personal knowledge. Id. at *16-17. Finding that the plaintiffs had failed to submit specific
evidence that the Nigerian judiciary would be biased against its own citizens in an action against Pfizer,
the district court alternatively held that Nigeria was an adequate alternate forum. Id. at *16, 18.
Several months later, the district court also granted Pfizer's motion to dismiss the Adamu case. Adamu,
399 F.Supp.2d 495. It relied on its Abdullahi III decision to hold that the plaintiffs could not establish
jurisdiction under the ATS. Id. at 501. The district court also incorporated the forum non conveniens
analysis from Abdullahi III to find that Nigeria is an adequate forum. Id. at 504. Applying the public
and private interest factors set forth in Gulf Oil Corp. v. Gilbert, 330 U.S. 501, 508-09, 67 S.Ct. 839, 91
L.Ed. 1055 (1947), superseded by statute on other grounds as recognized in Cowan v. Ford Motor Co.,
713 F.2d 100, 103 (5th Cir.1983), the court found that while public interest factors did not support either
forum, private interest factors weighed in favor of dismissal. Adamu, 399 F.Supp.2d. at 505-06. The
district court also dismissed the Adamu plaintiffs' Connecticut law claims, concluding that, under
Connecticut choice of law principles, the action was governed and barred by Nigerian law. Id. at 503.
The Abdullahi and Adamu plaintiffs appealed. Since then, a tectonic change has altered the relevant
political landscape. In May 2007, the state of Kano brought criminal charges and civil claims against
Pfizer, seeking over $2 billion in damages and restitution.4 Around the same time, the federal
government of Nigeria sued Pfizer and several of its employees, seeking $7 billion in damages.5 None of
these cases seek compensation for the subjects of the tests, who are the appellants before this Court.
Pfizer then notified this Court that in light of these recent developments, which it believed required
further consideration by the district court, it would not seek affirmance on the basis of forum non
conveniens.
DISCUSSION
The district court dismissed both actions based on its determination that it lacked subject matter
jurisdiction because plaintiffs failed to state claims under the ATS. We review dismissal on this ground
de novo. Rweyemamu v. Cote, 520 F.3d 198, 201 (2d Cir.2008). “To survive dismissal, the plaintiff[s]
must provide the grounds upon which [their] claim rests through factual allegations sufficient ‘to raise a
right to relief above the speculative level.’ ” ATSI Commc'ns, Inc. v. Shaar Fund, Ltd., 493 F.3d 87, 98 (2d
Cir.2007) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 127 S.Ct. 1955, 1965, 167 L.Ed.2d 929
(2007)).6
The Alien Tort Statute, 28 U.S.C. § 1350, provides that “[t]he district courts shall have original
jurisdiction of any civil action by an alien for a tort only, committed in violation of the law of nations or a
treaty of the United States.” Included in the Judiciary Act of 1789, the statute provided jurisdiction in
just two cases during the first 191 years after its enactment. See Taveras v. Taveraz, 477 F.3d 767, 771
(6th Cir.2007). In the last thirty years, however, the ATS has functioned slightly more robustly,
conferring jurisdiction over a limited category of claims.
We first extensively examined the ATS in Filartiga v. Pena-Irala, 630 F.2d 876 (2d Cir.1980), where we
held that conduct violating the law of nations is actionable under the ATS “only where the nations of the
world have demonstrated that the wrong is of mutual, and not merely several, concern, by means of
express international accords.” Id. at 888. Following Filartiga, we concluded that ATS claims may
sometimes be brought against private actors, and not only state officials, see Kadic v. Karadzic, 70 F.3d
232, 239 (2d Cir.1995), when the tortious activities violate norms of “universal concern” that are
recognized to extend to the conduct of private parties-for example, slavery, genocide, and war crimes,
id. at 240. This case involves allegations of both state and individual action. In Flores v. Southern
Peru Copper Corp., 414 F.3d 233 (2d Cir.2003), we clarified that “the law of nations” in the ATS context
“refers to the body of law known as customary international law,” which “is discerned from myriad
decisions made in numerous and varied international and domestic arenas” and “does not stem from
any single, definitive, readily-identifiable source.” Id. at 247-48. These principles are rejected in their
entirety by our dissenting colleague. In Flores, we concluded that ATS jurisdiction is limited to alleged
violations of “those clear and unambiguous rules by which States universally abide, or to which they
accede, out of a sense of legal obligation and mutual concern.” Id. at 252. Applying this standard, we
held that the appellants' claim that pollution from mining operations caused lung disease failed to state
a violation of customary international law. We reasoned that the “right to life” and the “right to
health” were insufficiently definite to constitute binding customary legal norms and that there was
insufficient evidence to establish the existence of a narrower norm prohibiting intranational pollution.
Id. at 254-55.
In 2004, the Supreme Court comprehensively addressed the ATS for the first time in Sosa v. Alvarez-
Machain, 542 U.S. 692, 124 S.Ct. 2739, 159 L.Ed.2d 718 (2004). Justice Souter, writing for the majority,
clarified that the ATS was enacted to create jurisdiction over “a relatively modest set of actions alleging
violations of the law of nations” and with “the understanding that the common law would provide a
cause of action.” Id. at 720, 723. The Supreme Court confirmed that federal courts retain a limited
power to “adapt [ ] the law of nations to private rights” by recognizing “a narrow class of international
norms” to be judicially enforceable through our residual common law discretion to create causes of
action. Id. at 728-29. It cautioned, however, that courts must exercise this power with restraint and
“the understanding that the door [to actionable violations] is still ajar subject to vigilant doorkeeping,”
permitting only those claims that “rest on a norm of international character accepted by the civilized
world and defined with a specificity comparable to the features of the 18th-century paradigms [the
Supreme Court has] recognized.” Id. at 725, 729. These 18th-century paradigms consist of offenses
against ambassadors, violations of the right to safe passage, and individual actions arising out of piracy.
Id. at 724. The common theme among these offenses is that they contravened the law of nations,
admitted of a judicial remedy, and simultaneously threatened serious consequences in international
affairs. Id. at 715. Lower courts are required to gauge claims brought under the ATS against the
current state of international law, but are permitted to recognize under federal common law only those
private claims for violations of customary international law norms that reflect the same degree of
“definite content and acceptance among civilized nations” as those reflected in the 18th-century
paradigms. Id. at 732-33. The Supreme Court in Sosa also counseled that “the determination whether
a norm is sufficiently definite to support a cause of action should (and, indeed, inevitably must) involve
an element of judgment about the practical consequences of making that cause available to litigants” in
federal courts. Id.
In this way Sosa set a “high bar to new private causes of action” alleging violations of customary
international law. Id. at 727. A federal court can recognize one only if a plaintiff identifies the
violation of a norm of customary international law that, as defined by the sources of such law that
United States courts “have long, albeit cautiously, recognized,” id. at 733-34 (referencing The Paquete
Habana, 175 U.S. 677, 700, 20 S.Ct. 290, 44 L.Ed. 320 (1900)), is sufficiently specific, universal, and
obligatory to meet the standards established by Sosa. See Sosa, 542 U.S. at 732, 124 S.Ct. 2739 (citing
with approval Tel-Oren v. Libyan Arab Republic, 726 F.2d 774, 781 (D.C.Cir.1984) (Edwards, J.,
concurring), and In re Estate of Marcos, Human Rights Litig., 25 F.3d 1467, 1475 (9th Cir.1994)).
Applying these principles, the Supreme Court held that the plaintiff, a Mexican national who sued a
fellow Mexican national under the ATS for allegedly aiding in his illegal abduction by agents of the U.S.
Drug Enforcement Agency, had failed to allege the violation of a customary international law norm with
the required precision. Sosa, 542 U.S. at 738, 124 S.Ct. 2739. The Supreme Court found that the
practical consequences of recognizing a general and broad customary international law prohibition of
arbitrary detention in a case involving “a single illegal detention of less than a day, followed by the
transfer of custody to lawful authorities and a prompt arraignment” would be “breathtaking” and
inappropriate. Id. at 736, 738, 124 S.Ct. 2739.
Since Sosa, this Court has reviewed three judgments dismissing claims under the ATS. In Khulumani v.
Barclay National Bank, Ltd., 504 F.3d 254 (2d Cir.2007) (per curiam), we held that the ATS conferred
jurisdiction over multinational corporations that purportedly collaborated with the government of South
Africa in maintaining apartheid because they aided and abetted violations of customary international
law. Id. at 260. In Vietnam Ass'n for Victims of Agent Orange v. Dow Chemical Co., 517 F.3d 104 (2d
Cir.2008), we concluded that the ATS did not support a claim that the defendants violated international
law by manufacturing and supplying Agent Orange and other herbicides used by the United States
military during the Vietnam War. Id. at 123. We reasoned that the sources of law on which the
appellants relied did not define a norm prohibiting the wartime use of Agent Orange that was both
universal and sufficiently specific to satisfy the requirements of Sosa. Id. at 119-23. Similarly, in Mora
v. People of the State of New York, 524 F.3d 183 (2d Cir.2008), we held that the norm at issue-one that
prohibits the detention of a foreign national without informing him of the requirement of consular
notification and access under Article 36(1)(b)(3) of the Vienna Convention on Consular Relations-was
insufficiently universal to support a claim under the ATS. Id. at 208-09.
Turning now to this appeal, and remaining mindful of our obligation to proceed cautiously and self-
consciously in this area, we determine whether the norm alleged (1) is a norm of international character
that States universally abide by, or accede to, out of a sense of legal obligation; (2) is defined with a
specificity comparable to the 18th-century paradigms discussed in Sosa; and (3) is of mutual concern to
States.
Appellants' ATS claims are premised on the existence of a norm of customary international law
prohibiting medical experimentation on non-consenting human subjects. To determine whether this
prohibition constitutes a universally accepted norm of customary international law, we examine the
current state of international law by consulting the sources identified by Article 38 of the Statute of the
International Court of Justice (“ICJ Statute”), to which the United States and all members of the United
Nations are parties. Flores, 414 F.3d at 250; see, e.g., United States v. Yousef, 327 F.3d 56, 100-01 (2d
Cir.2003). Article 38 identifies the authorities that provide “competent proof of the content of
customary international law.” Flores, 414 F.3d at 251. These sources consist of:
(a) international conventions, whether general or particular, establishing rules expressly recognized by
the contesting states;
(d) ․ judicial decisions and the teachings of the most highly qualified publicists of the various nations, as
subsidiary means for the determination of rules of law.
Statute of the International Court of Justice, art. 38(1), June 26, 1945, 59 Stat. 1055, 1060, T.S. No. 993
[hereinafter ICJ Statute].
The appellants ground their claims in four sources of international law that categorically forbid medical
experimentation on non-consenting human subjects: (1) the Nuremberg Code, which states as its first
principle that “[t]he voluntary consent of the human subject is absolutely essential”; (2) the World
Medical Association's Declaration of Helsinki, which sets forth ethical principles to guide physicians
world-wide and provides that human subjects should be volunteers and grant their informed consent to
participate in research; (3) the guidelines authored by the Council for International Organizations of
Medical Services (“CIOMS”), which require “the voluntary informed consent of [a] prospective subject”;
and (4) Article 7 of the International Covenant on Civil and Political Rights (“ICCPR”), which provides
that “no one shall be subjected without his free consent to medical or scientific experimentation.” 7
The district court found that “non-consensual medical experimentation violates the law of nations and,
therefore, the laws of the United States” and cited the Nuremberg Code for support. Abdullahi III, 2005
WL 1870811, at *9. It then noted that “[w]hile federal courts have the authority to imply the existence
of a private right of action for violations of jus cogens norms of international law, federal courts must
consider whether there exist special factors counseling hesitation in the absence of affirmative action by
Congress.” Id. (internal citations and quotation marks omitted). The district court then separately
analyzed the four sources of international law that prohibit nonconsensual medical experimentation on
humans and the Universal Declaration of Human Rights. Id. at *11-13. It found that with the
exception of the Nuremberg Code, these sources contain only aspirational or vague language lacking the
specificity required for jurisdiction. Id. at *12-13. It also determined that because the United States
did not ratify or adopt any of these authorities except the ICCPR, and because even the ICCPR is not self-
executing, none of them create binding international legal obligations that are enforceable in federal
court. Id. at *11-13. Finally, the district court concluded that the plaintiffs failed to provide a proper
predicate for ATS jurisdiction because none of the sources independently authorizes a private cause of
action and the inference of such a cause of action is a matter best left to Congress. Id. at *13-14.8
The district court's approach misconstrued both the nature of customary international law and the
scope of the inquiry required by Sosa. It mistakenly assumed that the question of whether a particular
customary international law norm is sufficiently specific, universal, and obligatory to permit the
recognition of a cause of action under the ATS is resolved essentially by looking at two things: whether
each source of law referencing the norm is binding and whether each source expressly authorizes a
cause of action to enforce the norm. But Sosa, as we have seen, requires a more fulsome and nuanced
inquiry. Courts are obligated to examine how the specificity of the norm compares with 18th-century
paradigms, whether the norm is accepted in the world community, and whether States universally abide
by the norm out of a sense of mutual concern. By eschewing this inquiry, the district court did not
engage the fact that norms of customary international law are “discerned from myriad decisions made
in numerous and varied international and domestic arenas” and “[do] not stem from any single,
definitive, readily-identifiable source.” Flores, 414 F.3d at 247-48.
The district court also inappropriately narrowed its inquiry in two respects. First, it focused its
consideration on whether the norm identified by the plaintiffs is set forth in conventions to which the
United States is a party, and if so, whether these treaties are self-executing or executed by federal
legislation. While adoption of a self-executing treaty or the execution of a treaty that is not self-
executing may provide the best evidence of a particular country's custom or practice of recognizing a
norm, see Flores, 414 F.3d at 257, the existence of a norm of customary international law is one
determined, in part, by reference to the custom or practices of many States, and the broad acceptance
of that norm by the international community. Agreements that are not self-executing or that have not
been executed by federal legislation, including the ICCPR, are appropriately considered evidence of the
current state of customary international law. See Khulumani, 504 F.3d at 284 (Katzmann, J.,
concurring) (noting that “[w]hether a treaty that embodies [a norm of customary international law] is
self-executing is relevant to, but is not determinative of, [the] question” of whether the norm permits
ATS jurisdiction). A formal treaty, moreover, is not the lone primary source of customary international
law. The ICJ Statute permits, and Sosa encourages, among other things, that courts consider
“international custom, as evidence of a general practice accepted as law.” ICJ Statute, supra, at art.
38(1); Sosa, 542 U.S. at 734, 124 S.Ct. 2739 (“[W]here there is no treaty, and no controlling executive or
legislative act or judicial decision, resort must be had to the customs and usages of civilized nations.”)
(quoting The Paquete Habana, 175 U.S. at 700, 20 S.Ct. 290).
Second, the district court's consideration of whether each source of law creates binding legal norms
failed to credit the fact that even declarations of international norms that are not in and of themselves
binding may, with time and in conjunction with state practice, provide evidence that a norm has
developed the specificity, universality, and obligatory nature required for ATS jurisdiction. See
Filartiga, 630 F.2d at 883 (“[A non-binding] Declaration creates an expectation of adherence, and insofar
as the expectation is gradually justified by State practice, a declaration may by custom become
recognized as laying down rules binding upon the States.”) (internal quotation marks omitted). The
district court should have considered a greater range of evidence and weighed differently the probative
value of the sources on which the appellants relied.
In sum, it was inappropriate for the district court to forego a more extensive examination of whether
treaties, international agreements, or State practice have ripened the prohibition of nonconsensual
medical experimentation on human subjects into a customary international law norm that is sufficiently
(i) universal and obligatory, (ii) specific and definable, and (iii) of mutual concern, to permit courts to
infer a cause of action under the ATS. See Sosa, 542 U.S. at 732-35, 124 S.Ct. 2739. We now proceed
with such an examination.
i. Universality
The appellants must allege the violation of a norm of customary international law to which States
universally subscribe. See Sosa, 542 U.S. at 732, 124 S.Ct. 2739; Vietnam Ass'n for Victims of Agent
Orange, 517 F.3d at 117. The prohibition on nonconsensual medical experimentation on human beings
meets this standard because, among other reasons, it is specific, focused and accepted by nations
around the world without significant exception.
The evolution of the prohibition into a norm of customary international law began with the war crimes
trials at Nuremberg. The United States, the Soviet Union, the United Kingdom and France “acting in
the interest of all the United Nations,” established the International Military Tribunal (“IMT”) through
entry into the London Agreement of August 8, 1945. M. Cheriff Bassiouni et al., An Appraisal of Human
Experimentation in International Law and Practice: The Need for International Regulation of Human
Experimentation, 72 J.Crim. L. & Criminology 1597, 1640 & n. 220 (1981) (internal quotation marks
omitted). Annexed to the London Agreement was the London Charter, which served as the IMT's
Constitution. See Agreement for the Prosecution and Punishment of the Major War Criminals of the
European Axis Powers, with annexed Charter of the International Military Tribunal art. 2, Aug. 8, 1945,
59 Stat. 1544, 82 U.N.T.S. 279. According to the Charter, the IMT had the “power to try and punish
persons who, acting in the interests of the European Axis countries, whether as individuals or as
members of organizations, committed,” among other offenses, war crimes and crimes against humanity.
Id. at art. 6.
The IMT tried 22 “major” Nazi war criminals leaving “lower-level” war criminals, including “[l]eading
physicians ․ and leading German industrialists,” to be tried in subsequent trials by U.S. military tribunals
acting “under the aegis of the IMT.” United States Holocaust Memorial Museum, War Crimes Trials,
Holocaust Encylopedia (2008), http://www.ushmm. org/wlc/article.php?lang=en&ModuleId=10005140.
The law that authorized the creation of the U.S. military tribunals, Control Council Law No. 10, was
enacted in 1945 by the Allied Control Council, see id., an authority through which the London
Agreement signatories exerted joint-control over Germany, see Encyclopedia Britannica, Germany,
Encyclopedia Britannica Online (2009), http://search.eb.com/eb/article-58214. Control Council Law No.
10 stated that its purpose was to “give effect to the terms of ․ the London Agreement ․ and the [London]
Charter,” and “to establish a uniform legal basis in Germany for the prosecution of war criminals.”
Allied Control Council No. 10, preamble, (Dec. 20, 1945), http://avalon.law.yale.edu/imt/imt10.asp. Law
No. 10 expressly incorporated the London Agreement, identifying it as an “integral part[ ] of this Law.”
Id. at art. I. Law No. 10 also authorized military tribunals of the occupying powers to prosecute
individuals for the same crimes over which the IMT had jurisdiction, including war crimes and crimes
against humanity, see id. at arts. II-III, and made military tribunal prosecutions subject to the IMT's right
of first refusal, see id. at art. III. Consequently, the U.S. military tribunals effectively operated as
extensions of the IMT, see Telford Taylor, Final Report to the Secretary of the Army on the Nuernberg
War Crimes Trials Under Control Council Law No. 107, 107 (1949) [hereinafter Report on Nuernberg War
Crimes Trials], available at http://www. loc.gov/rr/frd/Military_Law/pdf/NT_final-report.pdf (explaining
that “the trials under Law No. 10 were to be a means of carrying out such ‘declarations of criminality’ ․
as the International Military Tribunal might make” and that “[t]he first [IMT] trial and the 12 following
[military tribunal] trials ․ form a single sequence based on common principles”), and Control Council Law
No. 10 served to implement the commitments undertaken in the London Agreement, see id. at 7 (noting
that “the two documents supplemented each other” and “[m]ajor criminals not tried under the one
could be tried under the other”).
In August 1947, Military Tribunal 1, staffed by American judges and prosecutors and conducted under
American procedural rules, see George J. Annas, The Nuremberg Code in U.S. Courts: Ethics versus
Expediency, in The Nazi Doctors and the Nuremberg Code 201, 201 (George J. Annas & Michael A.
Grodin eds., 1992), promulgated the Nuremberg Code as part of the tribunal's final judgment against
fifteen doctors who were found guilty of war crimes and crimes against humanity for conducting
medical experiments without the subjects' consent, Brandt, 2 Nuremberg Trials, at 181-82. Among the
nonconsensual experiments that the tribunal cited as a basis for their convictions were the testing of
drugs for immunization against malaria, epidemic jaundice, typhus, smallpox and cholera. Id. at 175-
178. Seven of the convicted doctors were sentenced to death and the remaining eight were sentenced
to varying terms of imprisonment. Id. at 298-300. The tribunal emphasized that
[i]n every single instance appearing in the record, subjects were used who did not consent to the
experiments; indeed, as to some of the experiments, it is not even contended by the defendants that
the subjects occupied the status of volunteers.
Id. at 183. The judgment concluded that “[m]anifestly human experiments under such conditions are
contrary to the principles of the law of nations as they result from usages established among civilized
peoples, from the laws of humanity, and from the dictates of public conscience.” Id. (emphasis added
and internal quotation marks omitted). The Code created as part of the tribunal's judgment therefore
emphasized as its first principle that “[t]he voluntary consent of the human subject is absolutely
essential.” Id. at 181.
The American tribunal's conclusion that action that contravened the Code's first principle constituted a
crime against humanity is a lucid indication of the international legal significance of the prohibition on
nonconsensual medical experimentation. As Justices of the Supreme Court have recognized, “[t]he
medical trials at Nuremberg in 1947 deeply impressed upon the world that experimentation with
unknowing human subjects is morally and legally unacceptable.” United States v. Stanley, 483 U.S. 669,
687, 107 S.Ct. 3054, 97 L.Ed.2d 550 (1987) (Brennan, J., concurring in part and dissenting in part)
(emphasis added); see also id. at 709-10, 107 S.Ct. 3054 (O'Connor, J., concurring in part and dissenting
in part).
Moreover, both the legal principles articulated in the trials' authorizing documents and their application
in judgments at Nuremberg occupy a position of special importance in the development of bedrock
norms of international law. United States courts examining the Nuremberg judgments have recognized
that “[t]he universal and fundamental rights of human beings identified by Nuremberg-rights against
genocide, enslavement, and other inhumane acts ․-are the direct ancestors of the universal and
fundamental norms recognized as jus cogens,” from which no derogation is permitted, irrespective of
the consent or practice of a given State. Siderman de Blake v. Republic of Arg., 965 F.2d 699, 715 (9th
Cir.1992) (cited in Sampson v. F.R.G., 250 F.3d 1145, 1150 (7th Cir.2001)). As Telford Taylor, who first
served as an assistant to Justice Robert Jackson during his time as Chief Prosecutor for the IMT and then
became Chief of Counsel for War Crimes on the Nuremberg trials held under the authority of Control
Council Law No. 10, explained, “Nuernberg was based on enduring [legal] principles and not on
temporary political expedients, and this fundamental point is apparent from the reaffirmation of the
Nuernberg principles in Control Council Law No. 10, and their application and refinement in the 12
judgments rendered under that law during the 3-year period, 1947 to 1949.” Taylor, Report on
Nuernberg War Crimes Trials, at 107 (emphasis added).
Consistent with this view, the Code's first principle has endured: “[S]ignificant world opinion has not
come to the defense of the nature or manner in which the experiments were conducted in the Nazi
concentration camps.” Bassiouni et al., supra, at 1641. Rather, since Nuremberg, states throughout
the world have shown through international accords and domestic law-making that they consider the
prohibition on nonconsensual medical experimentation identified at Nuremberg as a norm of customary
international law.9
In 1955, the draft International Covenants on Human Rights was revised to add a second sentence to its
prohibition of torture and cruel, inhuman or degrading treatment or punishment. The addition
provided that “[i]n particular, no one shall be subjected without his free consent to medical or scientific
experimentation involving risk, where such is not required by his state of physical or mental health.”
Annotations on the text of the draft International Covenants on Human Rights, at 31, U.N. GAOR, 10th
Sess., Annexes, agenda item 28(II), U.N. Doc. A/2929 (July 1, 1955). The clause was later revised to
offer the simpler and sweeping prohibition that “no one shall be subjected without his free consent to
medical or scientific experimentation.” ICCPR, supra, at art. 7. This prohibition became part of Article 7
of the ICCPR, which entered into force in 1976, and is legally binding on the more than 160 States-
Parties that have ratified the convention without reservation to the provision.10 By its terms this
prohibition is not limited to state actors; rather, it guarantees individuals the right to be free from
nonconsensual medical experimentation by any entity-state actors, private actors, or state and private
actors behaving in concert.
Its status as a norm that states conceive as legally binding-and therefore part of customary international
law-is confirmed by Article 2 of the accord, which requires that “[e]ach State Party ․ undertake[ ] to
respect and to ensure to all individuals within its territory and subject to its jurisdiction the rights
recognized in the present Covenant.” ICCPR art. 2(1). The international community's recognition in
the ICCPR of its obligation to protect humans against nonconsensual medical experimentation,
regardless of the source of the action, is powerful evidence of the prohibition's place in customary
international law.
It is clear that, as the court mentioned in Sosa, the Universal Declaration of Human Rights and the ICCPR
themselves could not establish the relevant, applicable rule of international law in that case. Sosa, 542
U.S. at 754, 124 S.Ct. 2739. Nonetheless, the ICCPR, when viewed as a reaffirmation of the norm as
articulated in the Nuremberg Code, is potent authority for the universal acceptance of the prohibition
on nonconsensual medical experimentation. As we discuss below, see infra pp. 181-83, the fact that
the prohibition on medical experimentation on humans without consent has been consciously
embedded by Congress in our law and reaffirmed on numerous occasions by the FDA demonstrates that
the United States government views the norm as the source of a binding legal obligation even though
the United States has not ratified the ICCPR in full.11
In 1964, the World Medical Association adopted the Declaration of Helsinki, which enunciated standards
for obtaining informed consent from human subjects. It provided that in clinical research combined
with professional care, “[i]f at all possible, consistent with patient psychology, the doctor should obtain
the patient's freely given consent after the patient has been given a full explanation,” and that non-
therapeutic clinical research on a person “cannot be undertaken without his free consent, after he has
been fully informed.” World Med. Ass'n, Declaration of Helsinki: Code of Ethics of the World Medical
Association, art. III(3a), G.A. Res. (1964), http://www. pubmedcentral.nih.gov/picrender.fcgi?artid=
1816102 & blobtype=pdf. The Declaration has since been amended five times. The informed consent
provision now provides that “subjects must be volunteers and informed participants in the research
project.” Declaration of Helsinki, supra, at art. 20. The Declaration also requires that “[i]n any research
on human beings, each potential subject must be adequately informed of the aims, methods, ․
anticipated benefits and potential risks of the study, and the discomfort it may entail” and that
researchers “obtain the subject's freely-given informed consent, preferably in writing.” Id. at art. 22.
Although the Declaration itself is non-binding, since the 1960s, it has spurred States to regulate human
experimentation, often by incorporating its informed consent requirement into domestic laws or
regulations. See Delon Human & Sev S. Fluss, The World Medical Association's Declaration of Helsinki:
Historical and Contemporary Perspectives, 8-11 (July 24, 2001) (fifth draft), http://www.wma.net/e/
ethicsunit/pdf/draft_historical_ contemporary_ perspectives.pdf (describing legal and regulatory
developments in Australia, Belgium, Brazil, China, Israel, Japan, New Zealand, Norway, Switzerland, and
the United States following the Declaration of Helsinki). Currently, the laws and regulations of at least
eighty-four countries, including the United States, require the informed consent of human subjects in
medical research.12 That this conduct has been the subject of domestic legislation is not, of course, in
and of itself proof of a norm. See Flores, 414 F.3d at 249. However, the incorporation of this norm
into the laws of this country and this host of others is a powerful indication of the international
acceptance of this norm as a binding legal obligation, where, as here, states have shown that the norm
is of mutual concern by including it in a variety of international accords.
The history of the norm in United States law demonstrates that it has been firmly embedded for more
than 45 years and-except for our dissenting colleague-its validity has never been seriously questioned by
any court. Congress mandated patient-subject consent in drug research in 1962. Bassiouni et al.,
supra, at 1624 (citing 21 U.S.C. § 355(i) (1976)). In response, the FDA promulgated its first regulations
requiring the informed consent of human subjects. Tellingly, the sources on which our government
relied in outlawing non-consensual human medical experimentation were the Nuremberg Code and the
Declaration of Helsinki, which suggests the government conceived of these sources' articulation of the
norm as a binding legal obligation. Bassiouni et al., supra, at 1625-26 (citing 21 C.F.R. § 310.102(h)
(1980)).13 Today, FDA regulations require informed consent to U.S. investigators' research, whether
conducted domestically or in a foreign country, used to support applications for the approval of new
drugs. See 21 C.F.R. §§ 50.20, 50.23-.25, 50.27, 312.20, 312.120 (2008); 45 C.F.R. §§ 46.111, 46.116-
.117 (2008).
The importance that the United States government attributes to this norm is demonstrated by its
willingness to use domestic law to coerce compliance with the norm throughout the world. United
States law requires that, as a predicate to FDA approval of any new drug, both American and foreign
sponsors of drug research involving clinical trials, whether conducted here or abroad, procure informed
consent from human subjects. 21 C.F.R. §§ 312.20, 312.120 (2008); see also Dep't of Health & Human
Servs., Office of Inspector Gen., The Globalization of Clinical Trials 5 (2001), http://www.oig. hhs.gov/
oei/reports/oei-01-00-00190.pdf. Sponsors conducting research under an Investigational New Drug
Application (“IND”) are obligated to adhere to FDA regulations, which require informed consent. 21
C.F.R. § 312.20 (2008); The Globalization of Clinical Trials, supra, at 5. Prior to April 2008, sponsors
conducting research under non-IND guidelines were obligated to adhere to the ethical principles of the
1989 version of the Declaration of Helsinki or the host country's regulations, whichever offered greater
protection to the human subject. 21 C.F.R. § 312.120 (2007); The Globalization of Clinical Trials, supra,
at 5. The April 2008 revisions to the non-IND guidelines reaffirmed the informed consent requirement.
Human Subject Protection: Foreign Clinical Studies Not Conducted Under an Investigational New Drug
Application, 73 Fed.Reg. 22,800, 22,801, 22,803, 22,804, 22,816 (Apr. 28, 2008) (codified at 21 C.F.R. pt.
312). Foreign clinical studies not conducted under an IND must now comply with the Good Clinical
Practice guidelines (“GCP”) promulgated by the International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use, 62 Fed.Reg. 25,692 (May 9, 1997),
which require informed consent to medical experimentation. 21 C.F.R. § 312.120 (2008).
Additional international law sources support the norm's status as customary international law. The
European Union embraced the norm prohibiting nonconsensual medical experimentation through a
2001 Directive passed by the European Parliament and the Council of the European Union. The
Directive accepted the informed consent principles of the 1996 version of the Declaration of Helsinki.
Council Directive 2001/20/EC, preamble (2), 2001 O.J. (L 121) 37(EC) [hereinafter 2001 Clinical Trial
Directive]. It also required member States to adopt rules protecting individuals incapable of giving
informed consent and permitting clinical trials only where “the trial subject or, when the person is not
able to give informed consent, his legal representative has given his written consent after being
informed of the nature, significance, implications and risks of the clinical trial.” Id. at art. (1), (2)(d).
The Directive further required all member States to implement by 2004 domestic laws, regulations, and
administrative provisions to comply with its informed consent requirements. Id. at art. 22(1).
Since 1997, thirty-four member States of the Council of Europe have also signed the Convention on
Human Rights and Biomedicine, a binding convention and a source of customary international law.
Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the
Application of Biology and Medicine: Convention on Human Rights and Biomedicine, art. 5, 15-16,
opened for signature Apr. 4, 1997, E.T.S. No. 164, http://conventions.coe.int/Treaty/en/Treaties/html/
164.htm [hereinafter Convention on Human Rights and Biomedicine]; Convention on Human Rights and
Biomedicine, Chart of Signatures and Ratifications as of Aug. 8, 2008, http:// conventions.coe.int/
Treaty/Commun/ChercheSig.asp?NT=164 & CM =8 & DF=8/8/2008 & CL=ENG. It provides that an
“intervention in the health field may only be carried out after the person concerned has given free and
informed consent to it” and that the informed consent of human subjects is required for their
involvement in medical research. Convention on Human Rights and Biomedicine, supra, at art. 5.14 In
2005, the General Conference of the United Nations Educational, Scientific and Cultural Organization
(UNESCO) adopted the Universal Declaration on Bioethics and Human Rights, which requires “the prior,
free, express and informed consent of the person concerned” for research-oriented treatments.
Universal Declaration on Bioethics and Human Rights, UNESCO Gen. Conf. Res., at art. 6, 33rd Sess., 33
C/Resolution 36, (Oct. 19, 2005).
This history illustrates that from its origins with the trial of the Nazi doctors at Nuremburg through its
evolution in international conventions, agreements, declarations, and domestic laws and regulations,
the norm prohibiting nonconsensual medical experimentation on human subjects has become firmly
embedded and has secured universal acceptance in the community of nations. Unlike our dissenting
colleague's customary international law analysis, which essentially rests on the mistaken assumption
that ratified international treaties are the only valid sources of customary international law for ATS
purposes, see Dissent at 200-02, we reach this conclusion as a result of our review of the multiplicity of
sources-including international conventions, whether general or particular, and international custom as
identified through international agreements, declarations and a consistent pattern of action by national
law-making authorities-that our precedent requires us to examine for the purpose of determining the
existence of a norm of customary international law. Our dissenting colleague's reasoning fails to
engage the incompatibility of nonconsensual human testing with key sources of customary international
law identified in Article 38 of the ICJ's statute, most importantly international custom, as evidence of a
general practice accepted as law, as well as the general principles of law recognized by civilized nations.
See supra pp. 174-75.
ii. Specificity
Sosa requires that we recognize causes of action only to enforce those customary international law
norms that are no “less definite [in] content ․ than the historical paradigms familiar when [the ATS] was
enacted.” Sosa, 542 U.S. at 732, 124 S.Ct. 2739. The norm prohibiting nonconsensual medical
experimentation on human subjects meets this requirement. In United States v. Smith, 18 U.S. (5
Wheat) 153, 159-61, 5 L.Ed. 57 (1820), Justice Story found that “whatever may be the diversity of
definitions, ․ all writers concur, in holding, that robbery or forcible depredations upon the sea ․ is
piracy.” Id. at 161. We have little trouble concluding that a norm forbidding nonconsensual human
medical experimentation is every bit as concrete-indeed even more so-than the norm prohibiting piracy
that Story describes, or interference with the right of safe conducts and the rights of ambassadors,
which together are the paradigmatic norms identified in Sosa. Id. at 724, 124 S.Ct. 2739. The
Nuremberg Code, Article 7 of the ICCPR, the Declaration of Helsinki, the Convention on Human Rights
and Biomedicine, the Universal Declaration on Bioethics and Human Rights, the 2001 Clinical Trial
Directive, and the domestic laws of at least eighty-four States all uniformly and unmistakably prohibit
medical experiments on human beings without their consent, thereby providing concrete content for
the norm.15 The appellants allege that Pfizer knowingly and purposefully conducted such experiments
on a large scale. Whatever uncertainty may exist at the margin is irrelevant here because appellants
allege a complete failure on the part of Pfizer and the Nigerian government to inform appellants of the
existence of the Trovan experiments. These allegations, if true, implicate Pfizer and the Nigerian
government in conduct that is at the core of any reasonable iteration of the prohibition against
involuntary medical experimentation. While the prohibition in question applies to the testing of drugs
without the consent of human subjects on the scale Pfizer allegedly conducted, we do not suggest that it
would extend to instances of routine or isolated failures by medical professionals to obtain informed
consent, such as those arising from simple negligence. The allegations in the complaints involve
anything but a doctor's routine or erroneous failure to obtain such consent from his patient.
Customary international law proscribes only transgressions that are of “mutual” concern to States-
“those involving States' actions performed ․ towards or with regard to the other.” Flores, 414 F.3d at
249 (differentiating matters of “mutual” concern from those of “several” concern, in which “States are
separately and independently interested”). Conduct that States have prohibited through domestic
legislation is also actionable under the ATS as a violation of customary international law when nations of
the world have demonstrated “by means of express international accords” that the wrong is of mutual
concern. Filartiga, 630 F.2d at 888. An important, but not exclusive, component of this test is a
showing that the conduct in question is “capable of impairing international peace and security.” Flores,
414 F.3d at 249. Appellants have made both of these showings.
As we have seen, States throughout the world have entered into two express and binding international
agreements prohibiting nonconsensual medical experimentation: the ICCPR and the Convention on
Human Rights and Biomedicine. The entry of over 160 States into these agreements and the European
Union's passage of the 2001 Clinical Trial Directive demonstrates that States have not only acted
independently to outlaw large-scale, nonconsensual drug testing on humans, but they have also acted in
concert to do so. In other words, acting out of a sense of mutual concern, “the nations [of the world]
have made it their business, both through international accords and unilateral action,” to demonstrate
their intention to eliminate conduct of the type alleged in the complaints. Filartiga, 630 F.2d at 889.
The administration of drug trials without informed consent on the scale alleged in the complaints poses
a real threat to international peace and security. Over the last two decades, pharmaceutical
companies in industrialized countries have looked to poorer, developing countries as sites for the
medical research essential to the development of new drugs. See James V. Lavery, Putting
International Research Ethics Guidelines to Work for the Benefit of Developing Countries, 4 Yale J.
Health Pol'y L. & Ethics 319, 320-21 (2004); The Globalization of Clinical Trials, supra, at
8.16 Pharmaceutical companies recognize the potential benefits of drug trials to poor nations and have
sought to promote access to medicines and health care in underserved populations through
philanthropy and partnership with governments and NGOs. See, e.g., PhRMA, Press Releases:
Worldwide Pharmaceutical Industry Launches Global Health Progress Initiative to Expand Efforts to
Improve Health in Developing Countries (April 16, 2008), http://www.phrma.org/news_room/press_
releases/global_health_progress_initiative_launched_to_improve_health_in_deve loping_countries/
(describing initiative by worldwide pharmaceutical industry to “further access to medicines; build
capacity of health workers in developing nations; advocate for global action to address health
challenges; and continue R & D to develop new tools to fight diseases that plague the developing
world”); PhRMA, Profile2008: Pharmaceutical Industry 42 (2008), http://www.phrma.org/files/
2008% 20Profile.pdf (describing contributions by American pharmaceutical companies to the promotion
of global access to medicines and health care). This trend offers the possibility of enormous health
benefits for the world community. Life-saving drugs can potentially be developed more quickly and
cheaply, and developing countries may be given access to cutting edge medicines and treatments to
assist underresourced and understaffed public health systems, which grapple with life-threatening
diseases afflicting their populations.17
The success of these efforts promises to play a major role in reducing the cross-border spread of
contagious diseases, which is a significant threat to international peace and stability. The
administration of drug trials without informed consent on the scale alleged in the complaints directly
threatens these efforts because such conduct fosters distrust and resistance to international drug trials,
cutting edge medical innovation, and critical international public health initiatives in which
pharmaceutical companies play a key role. This case itself supplies an exceptionally good illustration of
why this is so. The Associated Press reported that the Trovan trials in Kano apparently engendered
such distrust in the local population that it was a factor contributing to an eleven month-long, local
boycott of a polio vaccination campaign in 2004, which impeded international and national efforts to
vaccinate the population against a polio outbreak with catastrophic results.18 According to the World
Health Organization, polio originating in Nigeria triggered a major international outbreak of the disease
between 2003 and 2006, causing it to spread across west, central, and the Horn of Africa and the Middle
East, and to re-infect twenty previously polio-free countries.19
The administration of drug trials without informed consent also poses threats to national security by
impairing our relations with other countries. Seven of the world's twelve largest pharmaceutical
manufacturers-a group that includes Pfizer-are American companies. Global 500, Fortune, July 21,
2008, http://money.cnn.com/magazines/fortune/global500/2008/industries/21/index.html.
Consequently, American companies are likely to be sponsors of medical experiments on human subjects
abroad.20 As this case illustrates, the failure to secure consent for human experimentation has the
potential to generate substantial anti-American animus and hostility. Unsurprisingly, as noted above,
see supra pp. 201-02, our government actively attempts to prevent this practice in foreign countries.
For example, federal law requires that data generated from testing on human subjects abroad that is
used to seek regulatory approval for a given drug must, at minimum, be the result of testing conducted
consistent with the requirements of informed consent. Consequently, the U.S. government denies
access to the U.S. market for any new drug unless the drug's research data is generated in a manner
consistent with the customary international law norm prohibiting drug trials on human subjects without
informed consent.
For these reasons, we hold that the appellants have pled facts sufficient to state a cause of action under
the ATS for a violation of the norm of customary international law prohibiting medical experimentation
on human subjects without their consent. In such an instance, ATS jurisdiction exists over plaintiffs'
claims. The district court determined that the norm existed, but concluded that because no single
source recognizing the norm was legally binding on the United States and created a private cause of
action, it could not infer such a right under the ATS. Presumably, on this basis, it simultaneously held
that there was no subject matter jurisdiction over plaintiffs' claims. Under Sosa, this approach was not
correct. Sosa makes clear that the critical inquiry is whether the variety of sources that we are required
to consult establishes a customary international law norm that is sufficiently specific, universally
accepted, and obligatory for courts to recognize a cause of action to enforce the norm. Nothing in Sosa
suggests that this inquiry can be halted if some of the sources of international law giving rise to the
norm are found not to be binding or not to explicitly authorize a cause of action.
We believe that the issues raised by this appeal regarding customary international law are framed by
our analysis and by that of our dissenting colleague. He contends that our analysis is created from
“whole cloth.” Dissent at 191. We believe that his approach to customary international law is
unselfconsciously reactionary and static. The approach does not accommodate itself to the normative
world that, by their commitments and conduct over the past fifty years, states-including our own-have
shown they believe to exist.
B. State Action
A private individual will be held liable under the ATS if he “acted in concert with” the state, i.e.,
“under color of law.” Kadic, 70 F.3d at 245. In making this determination, courts look to the standards
developed for finding state action in claims brought under 42 U.S.C. § 1983. Id. Under § 1983, state
action may be found when “there is such a ‘close nexus between the State and the challenged action’
that seemingly private behavior ‘may be fairly treated as that of the State itself.’ ” Brentwood Acad. v.
Tenn. Secondary Sch. Athletic Ass'n, 531 U.S. 288, 295, 121 S.Ct. 924, 148 L.Ed.2d 807 (2001) (quoting
Jackson v. Metropolitan Edison Co., 419 U.S. 345, 351, 95 S.Ct. 449, 42 L.Ed.2d 477 (1974)). That nexus
may exist “where a private actor has operated as a willful participant in joint activity with the State or its
agents,” Gorman-Bakos v. Cornell Coop. Extension of Schenectady County, 252 F.3d 545, 551-52 (2d
Cir.2001) (quoting Loce v. Time Warner Entertainment Advance/Newhouse Partnership, 191 F.3d 256,
266 (2d Cir.1999)), or “acts together with state officials or with significant state aid,” Kadic, 70 F.3d at
245. Pfizer meets this test.
The Appellants have alleged that the Nigerian government was involved in all stages of the Kano test
and participated in the conduct that violated international law. They allege that the Nigerian
government provided a letter of request to the FDA to authorize the export of Trovan, arranged for
Pfizer's accommodations in Kano, and facilitated the nonconsensual testing in Nigeria's IDH in Kano.
Despite overcrowding due to concurrent epidemics, the Nigerian government extended the exclusive
use of two hospital wards to Pfizer, providing Pfizer with control over scarce public resources and the
use of the hospital's staff and facilities to conduct the Kano test, to the exclusion of MSF.
The unlawful conduct is alleged to have occurred in a Nigerian facility with the assistance of the Nigerian
government and government officials and/or employees from the IDH and Aminu Kano Teaching
Hospital. Pfizer's research team in Kano was comprised of three American physicians, Dr. Abdulhamid
Isa Dutse (a physician in the Aminu Kano Teaching Hospital), and three other Nigerian doctors. The
American and Nigerian members of Pfizer's team allegedly jointly administered the Kano test. Finally,
in addition to assisting with the Kano test, Nigerian officials are alleged to have conspired to cover up
the violations by silencing Nigerian physicians critical of the test and by back-dating an “approval letter”
that the FDA and international protocol required to be provided prior to conducting the medical
experiment. In addition to these allegations, the Adamu plaintiffs explicitly allege that the Nigerian
government “was intimately involved and contributed, aided, assisted and facilitated Pfizer's efforts to
conduct the Trovan test,” “acted in concert with Pfizer,” and, according to a Nigerian physician involved
in the Trovan experimentation, appeared to “back[ ]” the testing. At the pleading stage, these
contentions meet the state action test because they adequately allege that the violations occurred as
the result of concerted action between Pfizer and the Nigerian government.
As an alternative to dismissal for failure to state a claim under the ATS, the district court dismissed the
actions on the ground of forum non conveniens. Appellants raised this issue on appeal. Ordinarily,
we review a forum non conveniens dismissal for abuse of discretion. Norex Petroleum Ltd. v. Access
Indus., Inc., 416 F.3d 146, 153 (2d Cir.2005). Since filing this appeal, however, Pfizer has notified the
Court that in light of recent developments, in particular the initiation of proceedings by the federal
government of Nigeria and the state of Kano against Pfizer and certain of its employees, it would not
seek affirmance of the judgment on the basis of forum non conveniens. The appellants agreed and
also requested that the issue be remanded. We accede to this request.
Although we are not now called upon definitively to review the district court's application of forum
non conveniens, in view of the frequency with which this issue has arisen and remained unsettled in this
case, we offer additional guidance to assist the parties and the district court. The three-step analysis
set forth in Iragorri v. United Techs. Corp., 274 F.3d 65, 71-75 (2d Cir.2001) (en banc), applies. In this
litigation, the second step of the analysis, which requires the district court to consider the adequacy of
the alternative forum, is pivotal. Dismissal is not appropriate if an adequate and presently available
alternative forum does not exist. Norex, 416 F.3d at 159. A forum in which defendants are amenable
to service of process and which permits litigation of the dispute is generally adequate. Id. at 157.
Such a forum may nevertheless be inadequate if it does not permit the reasonably prompt adjudication
of a dispute, if the forum is not presently available, or if the forum provides a remedy so clearly
unsatisfactory or inadequate that it is tantamount to no remedy at all. Piper Aircraft Co. v. Reyno, 454
U.S. 235, 254-55 & n. 22, 102 S.Ct. 252, 70 L.Ed.2d 419 (1981); USHA (India), Ltd. v. Honeywell Int'l, Inc.,
421 F.3d 129, 136 (2d Cir.2005); Norex, 416 F.3d at 160.
The defendant bears the burden of establishing that a presently available and adequate alternative
forum exists, and that the balance of private and public interest factors tilts heavily in favor of the
alternative forum. USHA (India), Ltd., 421 F.3d at 135; PT United Can Co. v. Crown Cork & Seal Co., Inc.,
138 F.3d 65, 74 (2d Cir.1998). Absent a showing of inadequacy by a plaintiff, “considerations of comity
preclude a court from adversely judging the quality of a foreign justice system.” PT United Can Co., 138
F.3d at 73. Accordingly, while the plaintiff bears the initial burden of producing evidence of corruption,
delay or lack of due process in the foreign forum, the defendant bears the ultimate burden of
persuasion as to the adequacy of the forum. See, e.g., Norex, 416 F.3d at 159-160.
When the district court granted Pfizer's motion, it identified the pivotal issue as whether the plaintiffs
produced sufficient evidence to show that Nigeria is an inadequate alternative forum. Abdullahi III,
2005 WL 1870811, at *15. Having found that they had not, it concluded that Nigeria was an adequate
forum. Id. at *16-18. In so doing, the district court omitted an analysis of whether Pfizer discharged
its burden of persuading the court as to the adequacy and present availability of the Nigerian forum and
improperly placed on plaintiffs the burden of proving that the alternative forum is inadequate. Cf.
DiRienzo v. Philip Servs. Corp., 294 F.3d 21, 30 (2d Cir.2002) (holding that it is error not “to hold
defendants to their burden of proof” of the Gilbert factors). On remand, the district court will have an
opportunity to reassess this issue, as well as the relationship between Fed.R.Civ.P. 44.1 and the Federal
Rules of Evidence.
The district court dismissed the Adamu plaintiffs' claims under the Connecticut Unfair Trade Practices
Act and the Connecticut Products Liability Act on the ground that Connecticut choice of law principles
applied and called for the application of Nigerian law. Adamu, 399 F.Supp.2d at 501-03. “We review
the district court's choice of law de novo.” Fin. One Pub. Co. Ltd. v. Lehman Bros. Special Fin., Inc., 414
F.3d 325, 331 (2d Cir.2005).
The district court correctly determined that Connecticut choice-of-law rules applied because it was
obligated to apply the state law that would have been applicable if the case had not been transferred
from Connecticut to New York. See Van Dusen v. Barrack, 376 U.S. 612, 639, 84 S.Ct. 805, 11 L.Ed.2d 945
(1964). Under Connecticut law, lex loci delicti, “the doctrine that the substantive rights and obligations
arising out of a tort controversy are determined by the law of the place of injury,” typically applies.
O'Connor v. O'Connor, 201 Conn. 632, 637, 519 A.2d 13 (1986). Lex loci delicti would require the
application of Nigerian law because the Adamu plaintiffs' injuries are alleged to have occurred there.
Connecticut, however, has conspicuously retreated from a rigid application of the doctrine. The
Connecticut Supreme Court held that lex loci delicti does not apply to a tort claim when doing so would
undermine expectations of the parties or an important state policy, produce an arbitrary and irrational
result, or where “reason and justice” counsel for the application of a different principle. Id. at 637, 648,
650, 519 A.2d 13. In such cases, Connecticut courts are required to apply the “most significant
relationship” analysis set forth in the Restatement (Second) of Conflict of Laws §§ 6 & 145 (1971)
[hereinafter Restatement (Second)]. O'Connor, 201 Conn. at 649-50, 519 A.2d 13.
Section 145(1) of the Restatement provides that “[t]he rights and liabilities of the parties with respect to
an issue in tort are determined by the local law of the state which, with respect to that issue, has the
most significant relationship to the occurrence and the parties under the principles stated in § 6.”
Restatement (Second) § 145(1). Section 6(2), in turn, provides that where a state is not guided by a
statutory directive on choice of law,
the factors relevant to the choice of the applicable rule of law include
Restatement (Second) § 6(2). The Connecticut Supreme Court has determined that Section 145(2)
provides courts with guidance regarding the evaluation of the policy choices set out in Sections 145(1)
and 6(2). O'Connor, 201 Conn. at 652, 519 A.2d 13. Section 145(2) assists with the application of the
principles of Section 6 to tort cases by calling for consideration of:
(b) the place where the conduct causing the injury occurred,
(c) the domicil, residence, nationality, place of incorporation and place of business of the parties, and
(d) the place where the relationship, if any, between the parties is centered.
Restatement (Second) § 145(2). These factors are “to be evaluated according to their relative
importance with respect to the particular issue.” Id.
The district court correctly decided to apply Sections 6 and 145 of the Restatement rather than lex loci
delicti. It applied the factors in Section 145(2) to determine whether Connecticut or Nigeria has the
most significant relationship to the conduct at issue, which it identified as “Pfizer's failure to inform the
children or their parents about the potential problems with Trovan, and the administration of Trovan
and low dosage of Ceftriaxone.” Adamu, 399 F.Supp.2d at 503 (citations omitted). It reasoned that
“the Nigerian contacts to this litigation are stronger than Connecticut's” and noted in particular that
both the plaintiffs' injuries and Pfizer's alleged conduct occurred in Nigeria, that the plaintiffs were
Nigerian residents, and that “the parties' relationship is centered” in Nigeria. Id. It determined that
most of the factors of Section 145(2) point toward applying Nigerian law and that the “sole basis” for the
applicability of Connecticut law was that “Pfizer performed research and development with respect to
Trovan and planned the experiment in Connecticut.” Id. For these reasons, it concluded that Nigeria's
interests were superior and that its law should apply. Id.
Although the district court correctly identified some of the pertinent factors, it ultimately erred in its
application of the “most significant relationship” test because it did not factor into its Section 145(2)
analysis the integral factors set out in Section 6(2). It did not, for example, discuss “the relevant
policies of the forum” or “the relevant policies of other interested states and the relative interests of
those states in the determination of the particular issue.” Restatement (Second) § 6(2)(b)-(c). Nor
did it analyze what “justified expectations” existed that could have prompted Pfizer reasonably to
believe that its conduct in Connecticut would not expose it to Connecticut law, or how Pfizer would have
been disadvantaged by litigating these claims in Connecticut. Id. § 6(2)(d). Finally, the district court
did not evaluate its own ability to determine and apply Connecticut, as opposed to Nigerian, law. Id. §
6(2)(g). For these reasons, we vacate the dismissal of the state law claims and remand to the district
court for further consideration.
CONCLUSION
For the foregoing reasons, we REVERSE the judgments of the district court and REMAND for further
proceedings.
The majority has undertaken to define a “firmly established” norm of international law, heretofore
unrecognized by any American court or treaty obligation, on the basis of materials inadequate for the
task. In deviating from our settled case law, the majority identifies no norm of customary international
law, it creates a new norm out of whole cloth. Because the majority's analysis misconstrues-rather
than vindicates-customary international law, I respectfully dissent.
Proceeding with “extraordinary care and restraint,” Flores v. S. Peru Copper Corp., 414 F.3d 233, 248 (2d
Cir.2003), this Court has upheld jurisdiction under the Alien Tort Statute, 28 U.S.C. § 1350 (“ATS”), in
only a handful of cases alleging violations of the most firmly established international law norms, see
Kadic v. Karadzic, 70 F.3d 232, 241-43 (2d Cir.1995) (genocide and war crimes); Amerada Hess Shipping
Corp. v. Argentine Republic, 830 F.2d 421, 426 (2d Cir.1987), rev'd on other grounds, 488 U.S. 428, 109
S.Ct. 683, 102 L.Ed.2d 818 (1989) (free passage of neutral ship in international waters); Filartiga v. Pena-
Irala, 630 F.2d 876, 878 (2d Cir.1980) (state-administered torture). In Sosa v. Alvarez-Machain, the
Supreme Court identified three such “paradigmatic” norms, namely “violation of safe conducts,
infringement of the rights of ambassadors, and piracy.” 542 U.S. 692, 724, 124 S.Ct. 2739, 159 L.Ed.2d
718 (2004). Rather than declare that list exhaustive for purposes of the ATS, the Court held that “any
claim based on the present-day law of nations [must] rest on a norm of international character accepted
by the civilized world and defined with a specificity comparable to the features of the 18th-century
paradigms we have recognized.” Id. at 725, 124 S.Ct. 2739. Accordingly, we are charged with
“vigilant doorkeeping” when reviewing ATS claims to ensure that they rest on “a narrow class of
international norms” comparable to the paradigms identified by the Supreme Court. Id. at 729, 124
S.Ct. 2739.
The majority identifies three criteria that must be satisfied before a violation of international law can be
actionable under the ATS: that the norm is (1) specific and definable, (2) universally adhered to out of a
sense of legal obligation, and (3) a matter of mutual concern, namely a matter “involving States' actions
performed towards or with regard to the other.” Flores, 414 F.3d at 249 (internal quotation and
alterations omitted). I agree with the methodology used by the majority to determine whether a norm
falls within the jurisdictional grant of the ATS, but I do not agree with their conclusion that a norm
against non-consensual medical experimentation on humans by private actors is (1) universal and
obligatory or (2) a matter of mutual concern.
The majority relies on eight sources of customary international law to support its determination that a
norm against non-consensual medical experimentation on humans by private actors is universal and
obligatory. However, this evidence falls far short of the quantum necessary to establish the existence
of such a norm: (1) the International Covenant on Civil and Political Rights has been described by the
Supreme Court as a “well-known international agreement[ ] that despite [its] moral authority, ha[s] little
utility,” in defining international obligations, Sosa, 542 U.S. at 734, 124 S.Ct. 2739, and moreover, it does
not apply to private actors, such as the Defendant in this action; (2) the Council of Europe's Convention
on Human Rights and Biomedicine-a regional convention-was not ratified by the most influential nations
in the region, such as France, Germany, Italy, the Netherlands, Russia and the United Kingdom, and it
was promulgated on April 4, 1997, one year after the conduct at issue in this litigation; (3) the UNESCO
Universal Declaration of Bioethics and Human Rights of 2005 and (4) the European Parliament Clinical
Trial Directive of 2001 both also post-date the relevant time period by several years; (5) the Declaration
of Helsinki issued by the World Medical Association, a private entity, and (6) the International Ethical
Guidelines for Research Involving Human Subjects promulgated by the Council for International
Organizations for Medical Sciences, another private entity, “express[ ] the sensibilities and the asserted
aspirations and demands of some countries or organizations” but are not “statements of universally-
recognized legal obligations,” Flores, 414 F.3d at 262; (7) states' domestic laws, which, unsupported by
express international accords, are not “significant or relevant for purposes of customary international
law,” id. at 249; and (8) the so-called Nuremberg Code, a statement of principles that accompanied a
criminal verdict, possesses at best “subsidiary” value as a judicial decision, Statute of the International
Court of Justice art. 38, June 26, 1945, 59 Stat. 1031, 33 U.N.T.S. 993 (“ICJ Statute”). Taken together,
this evidence falls short of charting the existence of a universal and obligatory international norm
actionable against non-government actors under the ATS.1
For these reasons, I conclude that non-consensual medical experimentation by private actors, though
deplorable, is not actionable under international law and would therefore affirm the district court's
dismissal of Plaintiffs' complaints.
DISCUSSION
In order for a principle to become a norm of customary international law, states must universally abide
by it out of a sense of legal obligation, and not merely aspiration. See Flores, 414 F.3d at 248. It
might seem obvious, but before one can determine whether a principle is universally followed, one must
define the principle in question. Like domestic law, international law is not a monolith-a unitary set of
rules applying indiscriminately to all actors that come within its reach. To the contrary, international
law consists of rules that govern only states, rules that apply to private parties-individuals and
corporations-and other rules that regulate both evenhandedly. See, e.g., Restatement (Third) of
Foreign Relations of the United States § 101 (1987) ( “Restatement (Third)”). As a result, the Supreme
Court has required courts deciding whether a principle is a customary international law norm to
consider “whether international law extends the scope of liability for a violation of a given norm to the
perpetrator being sued, if the defendant is a private actor such as a corporation or individual.” Sosa,
542 U.S. at 732 n. 20, 124 S.Ct. 2739; see also id. at 760, 124 S.Ct. 2739 (Breyer, J., concurring) (“The
norm must extend liability to the type of perpetrator (e.g., a private actor) the plaintiff seeks to sue.”).
The majority lists the norm at issue here as the prohibition of “medical experimentation on non-
consenting human subjects,” Maj. Op. at 174-75, and proceeds to analyze that norm without regard to
the alleged violator, see id. at 174-88. Put another way, the majority's analysis would be no different if
Plaintiffs had sued the Nigerian government, instead of, or in addition to, Pfizer. Such a broad,
simplified definition ignores the clear admonitions of the Supreme Court-and conflicts with prior
decisions of this Court-that a customary international law norm cannot be divorced from the identity of
its violator. The majority's analysis omits this critical consideration. As a result, the majority opinion
presents only half of the equation. To my mind, the majority should have asked whether customary
international law prohibits private actors from medical experimentation on non-consenting human
subjects. That question must be answered in the negative.
In Flores, we explained some of the difficulties inherent in determining what offenses violate customary
international law:
Customary international law is discerned from myriad decisions made in numerous and varied
international and domestic arenas. Furthermore, the relevant evidence of customary international law
is widely dispersed and generally unfamiliar to lawyers and judges. These difficulties are compounded
by the fact that customary international law ․ does not stem from any single, definitive, readily-
identifiable source.
414 F.3d at 247-48. We have consistently looked to the ICJ Statute as the starting point for
determining the proper sources of international law. See, e.g., id. at 250-51; United States v. Yousef,
327 F.3d 56, 100-03 (2d Cir.2003). That statute lists: (1) “international conventions, whether general
or particular, establishing rules expressly recognized by the contesting states”; (2) “international
custom, as evidence of general practice accepted as law”; (3) “the general principles of law recognized
by civilized nations”; and, in certain circumstances (4) “judicial decisions and the teachings of the most
highly qualified publicists of the various nations, as subsidiary means for the determination of rules of
law.” ICJ Statute art. 38.
The ability to pick and choose from this seemingly limitless menu of sources presents a real threat of
“creative interpretation.” Flores, 414 F.3d at 248; see also Amerada Hess, 830 F.2d at 429 (Kearse, J.,
dissenting). To mitigate this risk, and to prevent courts from becoming “roving commission [s],” Flores,
414 F.3d at 262, we have, in our cases, methodically assessed the weight and relative influence of not
only each class of sources listed in the ICJ Statute, but many individual sources within each class. The
near-infinite list of international law sources makes adherence to this precedent of paramount
importance, for our analysis demonstrates that not every source of international law carries equal
weight.
Instead of following and applying our framework, the majority substitutes in its place a compelling
narrative. Over the course of only a few pages, the majority employs several sources that it believes
demonstrate a customary norm against medical experimentation by non-state entities and weaves them
together to reach its conclusion. See Maj. Op. at 175-85. Nowhere does the majority examine these
sources in the context required by Sosa. The majority does not discuss the weight of these sources, how
they collectively demonstrate a customary norm, or how evidence supporting that norm compares with
our ATS precedent. Had they done so, I am hopeful that my colleagues would reach the same
conclusion that I do-that medical experimentation by private actors, while reprehensible, is not
actionable under international law.
In Flores, we noted that treaties are the strongest evidence of customary international law because they
“create legal obligations akin to contractual obligations on the States parties to them.” 414 F.3d at 256.
“[W]e look primarily to the formal lawmaking and official actions of States ․ as evidence of the
established practices of States.” Yousef, 327 F.3d at 103. But not all treaties are equal. Although
“[a]ll treaties that have been ratified by at least two States provide some evidence of the custom and
practice of nations ․ a treaty will only constitute sufficient proof of a norm of customary international
law if an overwhelming majority of States have ratified the treaty.” Flores, 414 F.3d at 256.
Moreover, the “evidentiary weight to be afforded to a given treaty varies greatly depending on (i) how
many, and which, States have ratified the treaty, and (ii) the degree to which those States actually
implement and abide by the principles set forth in the treaty.” Id. at 256-57. For instance, treaties
ratified by the United States are of greater evidentiary value if they are either self-executing or executed
through acts of Congress. See, e.g., id. at 257; Khulumani v. Barclay Nat'l Bank Ltd., 504 F.3d 254, 284
(2d Cir.2007) (Katzmann, J., concurring).
The International Covenant on Civil and Political Rights, Dec. 9, 1966, S. Exec. Doc. E, 95-2, 999 U.N.T.S.
171, 6 I.L.M. 368 (ratified by the United States June 8, 1992) (“ICCPR”) “guarantees a broad spectrum of
civil and political rights to individuals within signatory nations.” United States v. Duarte-Acero, 296 F.3d
1277, 1282 (11th Cir.2002). One of those rights-to be free of non-consensual medical or scientific
experimentation-is stated in Article 7.
The ICCPR is not appropriate evidence of customary international law for at least two reasons. First,
the Supreme Court in Sosa explicitly described the ICCPR as a “well-known international agreement[ ]
that, despite [its] moral authority, ha[s] little utility under the standard set out in this opinion,” because
the “United States ratified [it] on the express understanding that it was not self-executing and so did not
itself create obligations enforceable in the federal courts.” 542 U.S. at 734-35, 124 S.Ct. 2739
(emphasis added).
Second, whatever limited weight the ICCPR has with regard to state action, it does nothing to show that
a norm prohibiting involuntary medical experimentation applies to non-state entities. In citing its
seemingly universal language, the majority overlooks the ICCPR's operative section, which requires that
“[e]ach State Party ․ undertake[ ] to respect and to ensure to all individuals within its territory and
subject to its jurisdiction the rights recognized in the present Covenant.” ICCPR art. 2(1). Thus,
despite its broad text, the ICCPR by its own terms, only governs “the relationship between a State and
the individuals within the State's territory.” Duarte-Acero, 296 F.3d at 1283. Because the ICCPR only
creates obligations flowing from a state to persons within its territory, a non-state actor cannot be said
to have violated it. Thus, the ICCPR was relevant in Filartiga (decided before the Supreme Court limited
its utility), in the context of state-administered torture of one of its citizens in contravention of one of
the rights guaranteed by states in the ICCPR. See 630 F.2d at 884. But whatever its evidentiary value
had Plaintiffs sued the Nigerian government, the ICCPR clearly has none where the question is whether
international law includes a norm actionable against a private corporation.
The second treaty cited by the majority is the Convention on Human Rights and Biomedicine, Apr. 4,
1997, E.T.S. No. 164 (the “Convention”), promulgated by the Council of Europe. See Maj. Op. at 183.
Articles 5 2 and 16 3 of the Convention require that the subject of scientific research give his or her
informed consent, which may be withdrawn at any time.
The first problem with the majority's reliance on the Convention is that it is a regional agreement not
signed by the most influential states in the region. Membership in the Council of Europe is limited to
European states. See Statute of the Council of Europe, art. 4, May 5, 1949, E.T.S. No. 1. It is difficult to
see how the Convention demonstrates the universality of the medical experimentation principle when
its signatories are limited to one continent. The majority also notes that the Convention has been
signed by thirty-four states, see Maj. Op. at 183, but overlooks that it has only been ratified by twenty-
two, and a treaty only evidences the customs and practices of states that have ratified it. Flores, 414
F.3d at 256. Lastly, and perhaps more importantly, the Convention is lacking even as evidence of a
European norm, since it has not been ratified by the more influential European states, including France,
Germany, Italy, the Netherlands, Russia and the United Kingdom, and a treaty's evidentiary value
increases along with the influence in international affairs of the states that have ratified it. See id. at
257; Convention on Human Rights and Biomedicine, Chart of Signatures and Ratifications as of
December 23, 2008, http://conventions.coe. int/Treaty/Commun/ChercheSig.asp?NT =164 & CM=8 &
DF= 12/23/2008 & CL=ENG (“Convention Ratifications Chart”).
A second, more fundamental problem with the majority's reliance on the Convention is that it was
promulgated after the conduct at issue here. I know of no authority for an international ex post facto
definition of the law of nations by later signed treaties. Cf. Vietnam Ass'n for Victims of Agent Orange
v. Dow Chem. Co., 517 F.3d 104, 118 (2d Cir.2008) (“The United States did not ratify the 1925 Geneva
Protocol until 1975. Accordingly, the Protocol cannot be said to have constituted ‘a treaty of the
United States,’ 28 U.S.C. § 1350, during the period relevant to this appeal.”). Plaintiffs allege that the
Trovan testing occurred in March and April of 1996, but the Convention was not opened for signature
until April 4, 1997, and did not bind any state until Slovakia's ratification on January 15, 1998. See
Flores, 414 F.3d at 256(“A State only becomes bound by-that is, becomes a party to-a treaty when it
ratifies the treaty.”); Convention Ratifications Chart. The Convention is without import to this inquiry.
Two other post-1996 sources cited by the majority, the 2005 UNESCO Universal Declaration on Bioethics
and Human Rights and the 2001 European Parliament Clinical Trial Directive share equal evidentiary
irrelevance for the same reason.
Plaintiffs and the majority cite several multinational declarations, including the World Medical
Association's Declaration of Helsinki and the International Ethical Guidelines for Research Involving
Human Subjects promulgated by the Council for International Organizations of Medical Sciences
(“CIOMS Guidelines”), as additional evidence that the prohibition against non-consensual medical
experimentation applies to non-state actors. In doing so, the majority somehow overlooks our
decisions in Flores and Yousef.
In Flores, the declarations we rejected were put forth by international governmental bodies, the
Organization of American States and the United Nations Conference on Environment and Development.
Id. at 263. Here, the two declarations embraced by the majority were put forward by entirely private
organizations-hardly evidence of the state of international law. The Declaration of Helsinki was
adopted by the World Medical Association, a group comprised not of member states, but of physicians
and private national medical associations. “The World Medical Association (WMA) is an international
organization representing physicians ․ [and] has always been an independent confederation of free
professional associations.” See The World Medical Association, “About the WMA,” http://www.wma.
net/e/about/index.htm. The express terms of the Declaration of Helsinki make it abundantly clear that it
is hortatory, and not obligatory: “The World Medical Association (WMA) has developed the Declaration
of Helsinki as a statement of ethical principles․” See World Med. Ass'n, Declaration of Helsinki: Ethical
Principles for Medical Research Involving Human Subjects art. A(1), June 1964. Similarly, CIOMS is
“an international non-governmental, non-profit organization.” CIOMS, “What is CIOMS?”, http://www.
cioms.ch/jan2008_what_is_ cioms.pdf.
Treating these well-meaning, aspirational, but private, declarations as sources of international law runs
counter to our observation in Yousef that “no private person-or group of men and women such as
comprise the body of international law scholars-creates the law.” 327 F.3d at 102. This is so for good
reason. As we have seen in our ATS jurisprudence, international custom gives rise to legally
enforceable obligations. To include the political statements of private organizations in the select and
conscribed group of sources capable of creating international law would enfranchise non-democratic,
unaccountable entities with governmental authority. As a result, these declarations are “not proper
evidence of customary international law.” Flores, 414 F.3d at 262.
The majority focuses its lens on one line in Filartiga for the proposition that a “declaration may by
custom become recognized as laying down rules binding upon the States.” Maj. Op. at 177 (quoting
Filartiga, 630 F.2d at 883). In Filartiga, we were discussing a United Nations declaration, which though
not binding, “creates an expectation of adherence” because it “specif [ies] with great precision the
obligations of member nations.” 630 F.2d at 883. The declarations relied on by the majority were not
put forth by a governmental body such as the United Nations but by wholly private organizations,
incapable of creating legally binding obligations.
3. State Practice
The majority also points to the great number of states that, in their respective domestic laws, require
informed consent in medical research. That many countries have prohibited private actors from
conducting medical experiments or treatments without informed consent is certainly commendable and
worthy of praise, but not “significant or relevant for purposes of customary international law.” 4 See
Flores, 414 F.3d at 249. For it is only when states prohibit domestic action as a result of “express
international accords” that a wrong becomes a violation of customary international law. See Filartiga,
630 F.2d at 888 (quoting IIT v. Vencap, Ltd., 519 F.2d 1001, 1015 (2d Cir.1975) (Friendly, J.)). No such
international accord exists here.
Moreover, “substantive uniformity” among states' domestic laws is only a starting point for
demonstrating international custom through individual state practice, which should also reflect a
“procedural” consensus among states on how that behavior should be prosecuted-criminally and civilly.
See Sosa, 542 U.S. at 761-62, 124 S.Ct. 2739 (Breyer, J, concurring). As Justice Breyer noted in his Sosa
concurrence, the states of the world have reached both substantive and procedural agreement with
respect to only a handful of certain international law norms made actionable against non-state entities.
See id.; Part I(B) infra. Non-consensual medical testing is not among them.
The majority centers its analysis around the Nuremberg Code, but, in the process, critically misstates its
genesis and status in international law. See Maj. Op. at 177-79. Because the Code is a sui generis
source of international law, its context is vital to understanding what it is-and what it is not.
The Nuremberg trials are unquestionably one of this country's greatest and most enduring contributions
to the field of international law. As early as 1943, the Allied powers contemplated bringing Nazi war
criminals to justice after the conclusion of the Second World War. At the October 1943 Moscow
Conference, the United States, United Kingdom and Soviet Union issued a joint “Statement on
Atrocities,” warning that:
At the time of granting of any armistice to any government which may be set up in Germany, those
German officers and men and members of the Nazi party who have been responsible for or have taken a
consenting part in the above atrocities, massacres and executions will be sent back to the countries in
which their abominable deeds were done in order that they may be judged and punished according to
the laws of these liberated countries and of free governments which will be erected therein.
Moscow Declaration Statement of Atrocities, Oct. 30, 1943, 9 U.S. Dept of State Bull. 310 (signed by
President Roosevelt, Prime Minister Churchill and Premier Stalin). The statement added that German
criminals “whose offenses have no particular geographical localization ․ will be punished by joint
decision of the government of the Allies.” Id.
Following victory in Europe and the surrender of Germany, the Allies executed the London Charter on
August 8, 1945, establishing an International Military Tribunal to try the “major war criminals,” London
Charter, Agreement for the Prosecution and Punishment of the Major War Criminals of the European
Axis, art. 3, Aug. 8, 1945, 59 Stat. 1544, 82 U.N.T. S. 279, and leaving the door open for other war
criminals to be tried in any other “national or occupation court” that might be established, id. art. 6.
Alongside the London Charter, the Allies promulgated the Charter of the International Military Tribunal
and formed a four-member tribunal with one member appointed by each of the Allies, with jurisdiction
over “the major war criminals” accused of committing three crimes: crimes against peace,5 war
crimes,6 and crimes against humanity.7 Charter of the International Military Tribunal, arts. 2, 6, Aug. 8,
1945, 59 Stat. 1544, 82 U.N.T.S. 279. It was the International Military Tribunal that conducted the
celebrated trial that resulted in the convictions of 19 of 22 defendants, including high-ranking Nazi
officials Hermann Goering, Rudolf Hess, and Karl Doenitz. See generally Robert H. Jackson, Final Report
to the President on the Nuremberg Trials (Oct. 7, 1946). But the Nuremberg Code was adopted by a
different tribunal in a different trial.
Four months after the London Charter established the International Military Tribunal, the Allied Control
Council, the joint allied entity that governed post-war Germany, enacted Control Council Law No. 10,
which authorized each of the occupying Allies, within its own “Zone of Occupation,” to arrest and
prosecute “persons within such Zone suspected of having committed a crime,” 8 subject to a right of first
refusal by the International Military Tribunal. Allied Control Council Law No. 10 art. III, §§ 1, 3 (Dec.
20, 1945), in 1 Trials of War Criminals Before the Nuernberg Military Tribunals Under Control Council
Law No. 10, XVIII (William S. Hein & Co., Inc. 1997) (1949), available at http://www.loc.gov/rr/frd/
Military_law/pdf/NT_war-criminals_Vol-I. pdf (“1 Trials of War Criminals ”).
The first of the American trials arising under Control Council Law No. 10 was the “Medical Case” against
German doctors. On October 25, 1946, the American Office of Military Government for Germany
enacted General Order 68, constituting Military Tribunal 1, comprised of three American military judges
and one alternate judge. Id. at 5. That same day, Brigadier General Telford Taylor, Chief of Counsel for
War Crimes, signed an indictment in United States v. Karl Brandt, et al. charging 23 defendants with war
crimes, crimes against humanity, and conspiracy, and charging 10 of the defendants with membership in
the “SS,” an organization declared criminal by the International Military Tribunal. Id. at 8-18. These
charges were premised, primarily, on the defendants' forced medical experiments, which constituted
war crimes when performed on prisoners of war, and crimes against humanity when conducted on Nazi
concentration camp prisoners.
At the conclusion of the Medical Case, 16 of the 23 defendants were convicted of one or more of the
charges, and seven were ultimately sentenced to death. Along with their verdict, the military judges
enumerated ten principles that came to be known as the Nuremberg Code, the first of which states that
in medical experiments, the “voluntary consent of the human subject is absolutely essential.” 2 Trials
of War Criminals Before the Nuernberg Military Tribunals Under Control Council Law No. 10, 181
(William S. Hein & Co., Inc.1997) (1949), available at 7 http://www.loc.gov/rr/frd/Military_law/pdf/NT_
war-criminals_Vol-II.pdf (“2 Trials of War Criminals ”).
My colleagues contend that the Code flowed naturally from the principles of law espoused in the
London Charter. They are quite right, of course, that Control Council Law No. 10 was modeled after
the London Charter and the American and International military tribunals shared largely the same
general international law and procedural frameworks. The London Charter identified and defined
certain international law offenses-Crimes Against Humanity, Crimes Against Peace, and War Crimes-
while each of the twelve trials before the American military tribunal concerned a unique and horrific
context for the commission of those crimes, ranging from medical experimentation on prisoners to the
use of slave labor. For example, the definitions of Crimes Against Humanity and War Crimes under
which the Nazi doctors were tried in the Medical Case were virtually identical to those of the London
Charter. However, the majority overlooks the fact that the Nuremberg Code dealt not with these
general principles of law, but instead with the very specific issue of permissible medical
experimentation. The ethical principles espoused in the Code had no forebears in either the London
Charter or the judgment of the International Military Tribunal. They were developed exclusively in the
Medical Case.
I recite this history not to suggest that the Nuremberg Code is not an extraordinary or groundbreaking
document, but rather to demonstrate the difficulty inherent in measuring its evidentiary weight, as it
does not fit neatly into any of the categories this Court has identified for sources of international law.
For one thing, the Code was developed by the United States military and announced by an American
military court. See United States v. Stanley, 483 U.S. 669, 687, 107 S.Ct. 3054, 97 L.Ed.2d 550 (1987)
(Brennan, J., dissenting). Certainly, the Code is not a treaty and did not immediately bind any state.
Under the framework of the ICJ Statute-and, accordingly, this Court-because it was part of a criminal
verdict, its closest analogue is a judicial decision, but judicial decisions are only “subsidiary,” rather than
primary, sources of customary international law. See ICJ Statute art. 38; Maj. Op. at 173-74. I agree
with my colleagues that the Code has had significant import-influence that continues to this day. The
Code surely has evidentiary value in our inquiry, but there is nothing to indicate that the Code
establishes a norm of international law prohibiting non-consensual medical experimentation or
treatment by private actors, or compensates for the virtually non-existent evidentiary value of the other
sources cited by the majority.
Conscious of our obligation to measure the weight of the sources of international law in the aggregate,
what is the sum of the sources that serve as the cornerstone of the majority's conclusion? The ICCPR,
characterized by the Supreme Court as being of “little utility,” Sosa, 542 U.S. at 734, 124 S.Ct. 2739,
which, in any event, does not apply to private actors; a pair of private organizations' declarations that
our Circuit precedent tells us “are not proper evidence of customary international law,” Flores, 414 F.3d
at 262; one regional convention and two multi-national declarations that post-date the critical time
period and are thus completely irrelevant; states' domestic laws untethered to any international
agreement that we are told is not “significant or relevant for purposes of customary international law,”
id. at 249, 414 F.3d 233; and the Nuremberg Code, a document whose evidentiary value is unclear.
Simply put, the evidence here does not compare with the sources put forward in the few cases where
we have held a principle to be a norm of customary international law. Exercising “extraordinary care
and restraint,” see id. at 248, we have only upheld ATS jurisdiction in cases where the evidence of
customary international law was entirely overwhelming.9 In Filartiga, we were persuaded by the fact
that the “international consensus surrounding torture has found expression in numerous international
treaties and accords.” 630 F.2d at 883 (emphasis added). There, the State Department-“the political
branch with principal responsibility for conducting the international relations of the United States,”
Flores, 414 F.3d at 262-had expressly announced that the prohibition against torture had ripened into a
norm of customary international law.10 Filartiga, 630 F.2d at 884. In Kadic, we observed that genocide
was included in section 404 of the Restatement and that the Convention on the Prevention and
Punishment of the Crime of Genocide had been ratified by more than 120 nations, including the United
States, 70 F.3d at 240-42, while international criminalization of war crimes was established by four
Geneva Conventions, ratified by more than 180 nations, including the United States, id. at 242-43. In
Amerada Hess, it was similarly obvious that Argentina's Falkland War attack on an American ship
violated one of the oldest customary international law norms. 830 F.2d at 423-24. We cited a variety
of international accords establishing the right of a neutral ship to free passage. Id. at 424. After
tracing the norm to Blackstone, we concluded that it was “beyond controversy that attacking a neutral
ship in international waters ․ violates international law.” Id.
In those cases, the evidence of international acceptance of each norm with respect to each defendant
was “clear and unambiguous.” Flores, 414 F.3d at 252. In each case, the nations of the world
gathered to ratify in universal numbers treaties that specifically prohibited genocide, war crimes,
torture, and attacks on neutral ships-not in generalized human rights agreements but in accords with
those discrete norms as their exclusive subjects.
My colleagues contend that I look only to the presence (or, in this case, the absence) of a globally
ratified treaty as the exclusive source of an international law norm. Far from it-we have held that
customary international law “does not stem from any single, definitive, readily-identifiable source.” Id.
at 248. However, the great weight of ATS jurisdiction must rest upon a foundation sturdy enough to
support it. Just as it would be error to stubbornly require one source of sufficient strength to bear that
burden on its own, the majority is equally mistaken in its attempt to employ a series of extraordinarily
weak sources to secure a purported norm of customary international law. Our case law makes clear
that even when viewed collectively, these sources are incapable of carrying the weight placed upon
them by my colleagues.
B. Restatement § 404
Nor does Plaintiffs' purported norm resemble the select few norms for which international law extends
liability to private actors. Although the law of nations in general does not “confine[ ] its reach to state
action,” see Kadic, 70 F.3d at 239, courts must still consider whether the specific norm at issue does. In
Kadic, we noted that the Restatement (Third) of Foreign Relations Law of the United States
differentiates between “those violations that are actionable when committed by a state 11 and a more
limited category of violations” that apply with equal force to private actors. Id. at 240 (citing
Restatement (Third) §§ 404, 702). Section 404 of the Restatement authorizes universal criminal
jurisdiction over non-state entities “for certain offenses recognized by the community of nations as of
universal concern, such as piracy, slave trade, attacks on or hijacking of aircraft, genocide, war crimes,
and perhaps certain acts of terrorism, even where [no other basis of jurisdiction] is
present.” 12 Universal jurisdiction, not to be confused with universal acceptance of a norm for ATS
purposes, “permits a State to prosecute an offender of any nationality for an offense committed outside
of that State and without contacts to that State.” Yousef, 327 F.3d at 103.
The plaintiffs in Kadic alleged that Radovan Karadzic, the “president” of the self-proclaimed republic of
Srpska violated several international law norms, notably bans on genocide, war crimes and torture. 70
F.3d at 236-37. Treating Karadzic as a non-state actor, we reviewed not only the Restatement, but a
host of relevant international accords, leading us to conclude that by their own terms, the norms
prohibiting genocide and war crimes applied to private individuals, while torture and summary
execution “are proscribed by international law only when committed by state officials or under color of
law.” Id. at 241-43. We added that the “ ‘color of law’ jurisprudence of 42 U.S.C. § 1983 is a relevant
guide to whether a defendant has engaged in official action for purposes of jurisdiction under the
[ATS].” Id. at 245.
Five years later, we again determined whether an international law norm applied only to state actors.
See Bigio v. Coca-Cola Co., 239 F.3d 440 (2d Cir.2000). Building on Kadic, we held that ATS jurisdiction
over a non-governmental entity requires the violation of a norm “listed as an ‘act of universal concern’
in § 404 or ․ sufficiently similar to [those] acts for us to treat them as though they were incorporated
into § 404 by analogy,” or conduct committed under color of law. Id. at 448. In affirming the district
court's dismissal, we determined that the act at issue-discriminatory expropriation of property-is much
more like the acts listed in section 702 than those in section 404, and that the complaint did not allege
that Coca-Cola acted in concert with Egyptian state officials. Id. at 447-49. However, unlike in Kadic,
we saw no need to look beyond the Restatement to any sources of international law in order to
conclude that the norm did not apply to non-state entities. Compare id. at 448, with Kadic, 70 F.3d at
241-43. It is equally clear that section 404 of the Restatement does not reveal a norm of customary
international law prohibiting non-consensual medical experimentation by private actors.
To reiterate, section 404 lists only five specific acts for which universal criminal jurisdiction over private
actors exists: piracy, genocide, slave trade, war crimes, and attacks on aircrafts. See also Vietnam
Ass'n for Victims of Agent Orange, 517 F.3d at 116 (describing these five as comprising “the list of
principles that may be said to have ripened into universally accepted norms of international law”
(internal quotation marks omitted)). If anything, this Court has been even more stringent, holding that
in spite of the Restatement, federal courts could not try an alleged airline bomber under customary
international law principles of universal jurisdiction.13 See Yousef, 327 F.3d at 103-08. Regardless,
there is no dispute that none of the five acts in section 404 encompasses non-consensual medical
experimentation. Instead, Plaintiffs argue that it is “sufficiently similar” to those acts to support its
application to a private corporation.14 See Bigio, 239 F.3d at 448. This Court has never had occasion
to consider what types of acts are “sufficiently similar” to the section 404 acts except to conclude in
Bigio that discriminatory expropriation was not among them. Id. For similar reasons, neither is non-
consensual medical experimentation.
Universal jurisdiction originated with prosecutions of piracy more than 500 years ago. See Yousef, 327
F.3d at 104; United States v. Lei Shi, 525 F.3d 709, 723 (9th Cir.2008). As we explained in Yousef,
piracy is universally punishable not because it is uniquely heinous but “because of the threat that piracy
poses to orderly transport and commerce between nations and because the crime occurs statelessly on
the high seas.” 327 F.3d at 104. By 1822, it was beyond “doubt ․ that vessels and property in the
possession of pirates may be lawfully seized on the high seas by [any] person, and brought in for
adjudication.” United States v. the La Jeune Eugenie, 26 F. Cas. 832, 843 (C.C.D.Mass.1822) (No.
15,551); see also United States v. Smith, 18 U.S. 153, 5 Wheat. 153, 163, 5 L.Ed. 57 (1820) (Story, J.)
(discussing the bases for universal jurisdiction over piracy).
Private actors trading slaves (as opposed to those engaging in slavery in general) are subject to universal
criminal jurisdiction because the early treaties that formed the basis for customary international law
considered the slave trade akin to piracy. For example, the 1841 Treaty of London provided that:
Their Majesties the Emperor of Austria, the King of Hungary and Bohemia, the King of Prussia, and the
Emperor of all the Russians, engage to prohibit all trade in slaves, either by their respective subjects, or
under their respective flags, or by means of capital belonging to their respective subjects; and to
declare such traffic piracy. Their Majesties further declare that any vessel which may attempt to carry
on the Slave Trade, shall, by that fact alone, lose all right to the protection of their flag.
Treaty for the Suppression of the African Slave Trade art. I, Dec. 20, 1841, 92 Consol. T.S. 437 (emphasis
added), reprinted in M. Cherif Bassiouni & Edward M. Wise, Aut Dedere Aut Judicare: The Duty to
Extradite or Prosecute in International Law 132-33 (1995); see also Kenneth C. Randall, Universal
Jurisdiction Under International Law, 66 Tex. L.Rev. 785, 798 (1988) ( “Currently, states can recognize
universal jurisdiction over slave trading by ․ customary law.”). Although we declined to hold in Yousef
that the principle had ripened into a customary norm, attacks on airliners logically fit into this class
because, like the high seas, airspace is stateless and extraterritorial.
After World War II, universal criminal jurisdiction was extended to private actors-including many of the
Nazi defendants prosecuted under Control Council Law No. 10-accused of crimes against humanity such
as war crimes and genocide because, like piracy, “ ‘there is ․ a lack of any adequate judicial system
operating on the spot where the crime takes place-in the case of piracy it is because the acts are on the
high seas and in the case of war crimes because of a chaotic condition or irresponsible leadership in time
of war.’ ” Yousef, 327 F.3d at 105 (quoting Willard B. Cowles, Universality of Jurisdiction Over War
Crimes, 33 Cal. L.Rev. 177, 194 (1945)); see also Flores, 414 F.3d at 244 n. 18 (“Customary international
law rules proscribing crimes against humanity, including genocide, and war crimes, have been
enforceable against individuals since World War II.”).
In Yousef, we concluded that these acts share two common traits: they “(1) are universally condemned
by the community of nations, and (2) by their nature occur either outside of a State or where there is no
State capable of punishing, or competent to punish, the crime.” 327 F.3d at 105.
Non-consensual medical experimentation is not “sufficiently similar” to these crimes to warrant its
incorporation into section 404 by analogy. Plaintiffs acknowledge that the acts listed in section 404
share “a particular quality of crossing international boundaries,” a quality that they argue that medical
experimentation shares “because of the universal uses of medical research and the common practice of
physicians to travel to crisis areas to deliver humanitarian aid.” But the mere crossing of an
international border does not give rise to universal jurisdiction over non-state actors. We made this
clear in Yousef, where we rejected universal jurisdiction over an individual accused of bombing of an
aircraft leaving the Philippines for Japan. 327 F.3d at 98, 103. As we held, universal criminal
jurisdiction over private actors is only appropriate for acts which, “by their nature,” are beyond state
sovereignty. Id. at 105. Here, Pfizer's alleged actions occurred exclusively within Nigeria, and medical
experimentation is not a crime which, by its nature, is incapable of state punishment. Plaintiffs'
argument to the contrary is belied by the state and federal civil and criminal actions pending against
Pfizer in Nigeria. See Maj. Op. at 171-72.
As in Bigio, medical experimentation more closely resembles the acts for which only state actors may be
held responsible. Plaintiffs compare medical experimentation with slavery. Yet, under the
Restatement, while anyone may be prosecuted for engaging in the slave trade, slavery itself is only
actionable against state actors. See Restatement (Third) § 702(b) (“A state violates international law
if, as a matter of state policy, it practices, encourages, or condones ․ slavery ․”). Medical
experimentation resembles slavery in its grievous exploitation of unconsenting and unwilling subjects; it
also resembles torture in its infliction of horrific physical and emotional pain. However, both the
Restatement and this Court have recognized that the norm against torture reaches only state actors.
See Kadic, 70 F.3d at 243-44; Restatement (Third) § 702(d); see also Convention Against Torture and
Other Cruel, Inhuman or Degrading Treatment or Punishment art 1, Dec. 10, 1984, S. Treaty Doc. No.
100-20, 1465 U.N.T.S. 85 (“CAT”) (defining torture as being “inflicted by or at the instigation of or with
the consent or acquiescence of a public official or other person acting in an official capacity.”).15
One of the fundamental attributes of sovereignty is a state's authority to exercise criminal jurisdiction
over persons accused of committing crimes within its territory. The crimes listed in section 404 are not
the extraordinary exceptions because they are singularly reprehensible or deserving of condemnation.
Few would argue that piracy, for which private actors may be prosecuted universally but which requires
neither an act of violence nor the infliction of physical injury,16 is more heinous than torture or slavery,
practices made actionable only against state entities. Rather, by definition, these crimes occur in
locations where, or during times when, sovereignty, and a fortiori criminal jurisdiction, are incapable of
being exercised. Because medical experimentation is entirely intra national and fully subject to
domestic criminal jurisdiction, it is not “sufficiently similar” to those acts listed in section 404, and
cannot be incorporated by analogy as to reach private, non-state actors.
The defendants in the Medical Case were not charged with conducting non-consensual medical tests per
se. Rather, those tests, when conducted on prisoners of war and members of a discrete civilian
population imprisoned in concentration camps, constituted “war crimes” and “crimes against
humanity,” offenses for which customary international law has imposed individual responsibility. See
Flores, 414 F.3d at 244 n. 18. Unlike the Defendant in this action, the Nazi doctors convicted by the
American military tribunal were not private actors. Each convicted defendant held a position of
authority in either the medical services or the military of the Third Reich.17 See 1 Trials of War Criminals
29. Moreover, the atrocities for which they were convicted victimized state prisoners in state-
administered concentration camps, according to the Indictment, “for the benefit of the German Armed
Forces.” Id. at 11-14. It is difficult to imagine a more egregious example of the violation of a
customary international law norm or a more appropriate case for ATS jurisdiction.
The majority today authorizes the exercise of ATS jurisdiction over an entirely private corporation for
violating a previously unrecognized norm of international law. In doing so, my colleagues accept proof
far weaker than in any other case where this Court has identified a norm of customary international law,
and, apparently, overlook the fact that this purported norm in no way resembles those few norms
enforceable against private entities. When tasked by the Supreme Court with “vigilant doorkeeping”
to ensure that the list of actionable international norms remains “narrow,” Sosa, 542 U.S. at 729, 124
S.Ct. 2739, we must be no less demanding than we have been in the past. Under that standard, the
evidence put forward by Plaintiffs does not establish a norm of customary international law actionable
against private actors. I believe that the majority's decision departs from our settled case law and
lowers considerably our previously high bar for ATS jurisdiction.
II. Mutuality
There are many principles on which most states of the world community agree. Most find support and
enforcement in the richly diverse legal systems in place around the globe. But universal acceptance as
a normative principle is not enough to gain entrance into the “law of nations.” The norm must not only
be universal, it must touch on matters that are “of mutual, and not merely several, concern.” Filartiga,
630 F.2d at 888. Matters are of mutual concern when they “affect[ ] the relationship between states or
between an individual and a foreign state, and [are] used by those states for their common good and/or
dealings inter se.” IIT, 519 F.2d at 1015. On the other hand, matters of several concern are those “in
which States are separately and independently interested.” Flores, 414 F.3d at 249. For example, as
we noted in Flores, “murder of one private party by another, universally proscribed by the domestic law
of all countries ․ is not actionable under the [ATS] as a violation of customary international law because
‘the nations of the world’ have not demonstrated that this wrong is of mutual, and not merely several,
concern.” Id. (quotation marks omitted). The majority concludes that non-consensual medical
experimentation by one private party on another is a matter of mutual concern. I disagree.
We have consistently held that the best evidence that states consider a matter to be of mutual concern
is the fact that they have agreed to be bound “by means of express international accords.” Filartiga,
630 F.2d at 888; see Flores, 414 F.3d at 249; Khulumani, 504 F.3d at 274 n. 7 (Katzmann, J., concurring).
The majority points to the ICCPR, the Convention on Human Rights and Biomedicine, and the 2001
Clinical Trial Directive as evidence that “States throughout the world have entered into ․ express and
binding international agreements prohibiting nonconsensual medical experimentation.” See Maj. Op.
at 185. But those agreements fail to demonstrate mutuality for the same reason they fail to
demonstrate universality-the ICCPR does not address acts by non-state actors and the other two were
not in force at the time of the alleged misconduct. Whatever international consensus has been
reached as to non-consensual medical experimentation by private actors has not yet “found expression
in numerous treaties and accords,” cf. Filartiga, 630 F.2d at 883. The majority cites no worldwide,
multi-continental, universally applicable “Convention Against Medical Experimentation,” because, at the
moment, none exists. That fact alone distinguishes this case from Filartiga, Amerada Hess, and Kadic.
In the absence of a binding global treaty, the majority seeks to demonstrate mutuality of concern by
describing the downstream effects of non-consensual medical experimentation. In essence, the
majority contends that non-consensual medical experiments feed distrust among their victims, which, in
turn, engenders a general reluctance to seek future medical attention or vaccination, which, in turn,
helps accelerate the spread of infectious diseases across international borders. See Maj. Op. at 186-87.
Indeed, I would concede that the majority may be quite right. But a smaller, more interdependent
world community has not been employed by the Supreme Court (or any other court to my knowledge)
to convert claims such as those presented here into violations of the law of nations. In fact, the
majority's theory would be no different when evaluating the medical malpractice of Pfizer's research
physicians or the strict products liability for its allegedly defective drug, but malpractice and products
liability are among the quintessential subjects of domestic law.
It is not enough that a wrong could create international ramifications; in order for it to be a matter of
mutual concern, it must “threaten[ ] serious consequences in international affairs.” Sosa, 542 U.S. at
715, 124 S.Ct. 2739. The Supreme Court listed three historical mutual wrongs as guideposts to frame
this inquiry: infringement of the rights of ambassadors, the violation of safe conducts and piracy. Id. at
715, 720, 124 S.Ct. 2739. An assault against an ambassador “impinged upon the sovereignty of the
foreign nation and if not adequately redressed could rise to an issue of war.” Id. at 715, 124 S.Ct. 2739.
The 18th century safe-conduct document was the historical equivalent of the modern passport, “which
entitles a bearer with a valid visa to safe passage to, within, and out of a foreign land pursuant to a
treaty or an agreement negotiated by his or her sovereign and the host sovereign.” Taveras v. Taveraz,
477 F.3d 767, 773 (6th Cir.2007) (quoting Thomas H. Lee, The Safe-Conduct Theory of the Alien Tort
Statute, 106 Colum. L.Rev. 830, 874 (2006)). Thus, “the purpose of the doctrine of safe conducts under
the law of nations is to protect the safety and security of the person and property of the journeying alien
bearing the safe conduct privilege (and consequently to preserve commercial and diplomatic
relationships between the alien's host and home countries).” Id. at 773-74. This is still true today-a
passport issued by the United States contains an official request from the Secretary of State to an
authority of another sovereign state: “The Secretary of State of the United States of America hereby
requests all whom it may concern to permit the citizen/national of the United States named herein to
pass without delay or hindrance and in case of need to give all lawful aid and protection.” Breaches of
customary international law impair the normal expectations that nations have in dealing with other
nations. They must threaten serious consequences in international affairs because the norms were,
and still are, the foundation for states' formal relationships with one another.
Piracy does not fit squarely with the other two Sosa historical paradigms, but the threat to international
affairs posed by piracy needs no detailed exegesis. Suffice it to say that one of the young Republic's
first military tests was its campaign against the Barbary Pirates, see, e.g., Act For the Protection of the
Commerce and Seamen of the United States Against the Tripolitan Cruisers, ch. IV, § 2, 2 Stat. 129, 130
(1802) (authorizing President Jefferson to instruct the armed forces to “seize and make prize of all
vessels, goods and effects, belonging to the Bey of Tripoli ․ and also to cause to be done all such other
acts of precaution or hostility as the state of war will justify, and may, in his opinion, require.”), and
piracy continues to threaten serious consequences in international affairs today, see S.C. Res. 1851, ¶ 2,
U.N. Doc. S/RES/1851 (Dec. 16, 2008) (calling upon states “to take part actively in the fight against piracy
and armed robbery at sea off the coast of Somalia”).
We have accepted no lesser showing in our case law. The threat posed by genocide is so great that
states are empowered to request “the competent organs of the United Nations to take such action
under the Charter of the United Nations as they consider appropriate for the prevention and
suppression of acts of genocide.” Convention on the Prevention and Punishment of the Crime of
Genocide art. 8, Dec. 9, 1948, 102 Stat. 3045, 78 U.N.T.S. 277. The Geneva Conventions collectively
establish, and obligate contracting parties to follow, the laws of war-almost by definition a matter of
international affairs. See Kadic, 70 F.3d at 242-43. On the other hand, because international law does
not define torture to include acts by private entities, torturous conduct by non-state actors-while
criminalized domestically-is not a matter of mutual concern. Id. at 243-44.
Demonstrating that a wrong is a matter of mutual concern must necessarily be difficult. The Supreme
Court has only opened the door for ATS jurisdiction over a “narrow set of violations of the law of
nations, admitting of a judicial remedy and at the same time threatening serious consequences in
international affairs.” Sosa, 542 U.S. at 715, 124 S.Ct. 2739. The nations of the world have not yet
demonstrated that non-consensual medical experimentation by non-state actors “is of mutual, and not
merely several, concern, by means of express international accords.” Filartiga, 630 F.2d at 888. Nor
does it threaten serious consequences in international affairs in the same manner or to the same extent
as the historical paradigms listed by the Supreme Court or their modern counterparts identified by this
Court. Without either showing, I cannot agree with the majority that non-consensual medical
experimentation by private actors is a matter of mutual concern.
The fact that medical experimentation by private actors is not a subject of customary international law
does not end the inquiry. If international law supports state liability but not private liability, a private
actor may still be liable if he or she “acted under color of law.” In that regard, we are told to employ
our 42 U.S.C. § 1983 jurisprudence in the inquiry. See Bigio, 239 F.3d at 448; Kadic, 70 F.3d at 245.
As an initial matter, this requires that the law of nations includes a norm actionable against states,
which, in the instant case, is far from certain. But even assuming, for argument's sake, that
international law prohibits states from conducting non-consensual medical tests, Plaintiffs have not
demonstrated that Pfizer acted under the color of law.
This issue requires a bit of procedural context. In 2002, Pfizer moved to dismiss Plaintiffs' complaint in
Abdullahi on the grounds that (1) Plaintiffs had not alleged that Pfizer was a state actor, and (2) the
alternate ground of forum non conveniens. See Abdullahi v. Pfizer, Inc., No. 01 Civ. 8118, 2002 WL
31082956, at *12 (S.D.N.Y. Sept. 17, 2002). Judge Pauley granted the forum non conveniens motion,
but denied the state action motion, concluding that Plaintiffs “sufficiently allege[d] that the former
Nigerian government and Pfizer were joint participants in the Trovan treatment.” Id. at *6. Plaintiffs
appealed the district court's dismissal, and Pfizer cross-appealed from the court's denial of its motion to
dismiss on state action. See Abdullahi v. Pfizer, Inc., 77 Fed.Appx. 48 (2d Cir.2003). On appeal, we
vacated the district court's judgment of dismissal, and did not reach Pfizer's cross-appeal, noting that
our intervening decision in Flores might have some application on remand. Id. at 53. Back before
Judge Pauley, Pfizer filed a new motion to dismiss, arguing that Plaintiffs failed to state a claim under the
substantially different ATS landscape which now included the Supreme Court's decision in Sosa and our
decision in Flores. See Abdullahi v. Pfizer, Inc., No. 01 Civ. 8118, 2005 WL 1870811, at *3 (S.D.N.Y. Aug.
9, 2005). Both of these decisions made clear that the identity of the defendant is a critical component
of whether a principle is a norm of customary international law. Without addressing or affirming its
previous conclusion finding sufficient allegations of state action, the district court granted Pfizer's
motion to dismiss, holding that medical experimentation was not actionable under the law of nations.
Id. at *18. On appeal to this Court, both parties addressed the issue of state action in their briefs.
The majority concludes that Plaintiffs' allegations of state action were sufficient to defeat a motion to
dismiss. See Maj. Op. at 187-88. I cannot agree.
In their twin complaints, which total 628 paragraphs, Plaintiffs make only four allegations concerning the
role of the Nigerian government in the Trovan experiments: (1) in order for the FDA to authorize the
export of Trovan, “Pfizer obtained the required letter of request from the Nigerian government”; (2) the
government “arrang[ed] for Pfizer's accommodation in Kano”; (3) the government acted “to silence
Nigerian physicians critical of [Pfizer's] test”; and (4) the government “assign[ed] Nigerian physicians to
assist in the project.” 18 Elsewhere in their complaints, Plaintiffs note in conclusory fashion that a
Nigerian doctor did not publicly object to the Trovan study because it “seemed to have the backing of
the Nigerian government.”
In their brief to this Court, Plaintiffs seek to bolster their complaints by describing the role of “Nigerian
government doctors” at the allegedly government-owned hospital that hosted the study. However,
the portions of the complaints that they cite do not support their contentions. Nowhere in their
complaints did Plaintiffs allege that the hospital was, in fact, government owned or administered, nor
did they allege that the four Nigerian doctors working with Pfizer were employed by the government,
and our review of a decision to grant a motion to dismiss “is limited to the facts as asserted within the
four corners of the complaint” and any attached documents. McCarthy v. Dun & Bradstreet Corp., 482
F.3d 184, 191 (2d Cir.2007).
These bare allegations are plainly insufficient to survive a motion to dismiss for lack of state action.
The Supreme Court's case law on state action is hardly a model of clarity, but certain principles are well-
settled. As a threshold matter, the conduct alleged attributable to the state must be defined with the
requisite specificity. “When analyzing allegations of state action, we begin ‘by identifying the specific
conduct of which the plaintiff complains,’ ” Tancredi v. Metro. Life Ins. Co., 316 F.3d 308, 312 (2d
Cir.2003) (quoting Am. Mfrs. Mut. Ins. Co. v. Sullivan, 526 U.S. 40, 51, 119 S.Ct. 977, 143 L.Ed.2d 130
(1999)), and in most cases, a finding of state action “must be premised upon the fact that the State is
responsible ” for that specific conduct, Horvath v. Westport Library Ass'n, 362 F.3d 147, 154 (2d
Cir.2004) (internal quotation omitted). Determining state action in these cases “requires tracing the
activity to its source to see if that source fairly can be said to be the state.” Leshko v. Servis, 423 F.3d
337, 340 (3d Cir.2005); see also Hadges v. Yonkers Racing Corp., 918 F.2d 1079, 1082-83 (2d Cir.1990).
As we recently stated, when confronted with a motion to dismiss, it “is not enough ․ for a plaintiff to
plead state involvement in some activity of the institution alleged to have inflicted injury upon a
plaintiff; rather, the plaintiff must allege that the state was involved with the activity that caused the
injury giving rise to the action.” Sybalski v. Indep. Group Home Living Program, Inc., 546 F.3d 255, 257-
58 (2d Cir.2008) (internal quotations omitted).
Here, that activity was not, as the majority apparently concludes, conducting the Trovan trials in general,
but rather administering the drug without informed consent. Although Plaintiffs allege that the
Nigerian government requested the import of Trovan and arranged for Pfizer's accommodations and
some medical staff in Kano, they do not allege that the government or any government employee
played any role in either administering Trovan without consent or deciding to do so in the first instance.
The Supreme Court has described “the typical case raising a state-action issue” as one in which “a
private party has taken the decisive step that caused the harm to the plaintiff, and the question is
whether the State was sufficiently involved to treat that decisive conduct as state action.” NCAA v.
Tarkanian, 488 U.S. 179, 192, 109 S.Ct. 454, 102 L.Ed.2d 469 (1988). Plaintiffs have not alleged any
facts that would indicate that the answer here is “yes.”
Plaintiffs' complaints are more noteworthy for what they do not allege than what they do. They have
not suggested that Pfizer was exercising any delegated state authority, cf. West v. Atkins, 487 U.S. 42,
108 S.Ct. 2250, 101 L.Ed.2d 40 (1988), or that the Nigerian government “knowingly accept[ed] the
benefits derived from [the unlawful] behavior,” Tarkanian, 488 U.S. at 192, 109 S.Ct. 454. Plaintiffs
have not alleged that Pfizer conspired with government officials to deprive the subjects of their rights,
cf. Fries v. Barnes, 618 F.2d 988, 991 (2d Cir.1980), nor have they alleged that the Nigerian government
exercised any coercive power over Pfizer, cf. Brentwood Acad. v. Tenn. Secondary Sch. Athletic Ass'n,
531 U.S. 288, 296, 121 S.Ct. 924, 148 L.Ed.2d 807 (2001). In fact, Plaintiffs did not allege that any
Nigerian government officials even knew about the non-consensual tests, because if Nigerian
government doctors were somehow involved in the study, Plaintiffs did not specify what role, if any,
they played.
The case of Beanal v. Freeport-McMoRan, Inc., 969 F.Supp. 362 (E.D.La.1997), aff'd 197 F.3d 161 (5th
Cir.1999), is instructive. In Beanal, plaintiffs seeking to recover under the ATS sought to establish state
action on the basis of the Indonesian military's involvement in allegedly actionable conduct. The court
rejected that argument, holding that plaintiffs had not “alleged whether the military personnel helped
enforce Freeport's policies or merely observed ․ the violative conduct.” Id. at 378. Broad conclusory
statements of state involvement are not sufficient to establish state action; “there must be some
allegation indicating that the troops jointly cooperated in the conduct, jointly participated in the
conduct, influenced the conduct or played an integral part in the deprivation of human rights.” Id. at
379. The same is true here.19 Plaintiffs' allegations are inadequate.
Even without alleging that the State “coerced or even encouraged” the act complained of, Plaintiffs can
still survive a motion to dismiss if “the relevant facts show pervasive entwinement to the point of largely
overlapping identity between the State and the entity that the plaintiff contends is a state actor.”
Horvath, 362 F.3d at 154 (quotation omitted). This line of cases revolves around the relationship
between the state and the actor, as opposed to the specific act. Showing “overlapping identity” is
highly uncommon, and most often arises where a private actor is performing one of the few functions
traditionally and exclusively reserved to the state or is controlled by a state entity. State assistance by
itself is insufficient-the relevant question is whether the decisionmakers were ostensibly state actors.
We answered that question in the affirmative in Horvath, where half of the putatively private
defendant's trustees were state appointees. Id. at 153. But the assistance alleged by Plaintiffs-helping
to procure a ward in a hospital and arranging for the assistance of a handful of doctors-is not enough to
clear this hurdle. Using government property, government staff, and even government funds does not
make a private entity a state actor when its decisions are made independently of the state. See Yeo v.
Town of Lexington, 131 F.3d 241, 254 (1st Cir.1997) (en banc).
Plaintiffs' generalized allegations (unsupported by factual allegations) that the government acted to
silence critics of the test are no more helpful. They do not allege who these government officials were,
how they acted to silence critics, or when in the sequence of events this conduct occurred. Such a
“merely conclusory allegation that a private entity acted in concert with a state actor does not suffice to
state a § 1983 claim against the private entity.” Ciambriello v. County of Nassau, 292 F.3d 307, 324 (2d
Cir.2002).
At most, Plaintiffs' complaints alleged that the Nigerian government acquiesced to or approved the
Trovan program in general without knowing its disturbing details. That it approved the program is
hardly surprising-in the midst of a widespread epidemic, the Nigerian government likely welcomed help
from every entity offering it, but “[m]ere approval of or acquiescence in the initiatives of a private party
is not sufficient to justify holding the State responsible for those initiatives.” Blum v. Yaretsky, 457 U.S.
991, 1004-05, 102 S.Ct. 2777, 73 L.Ed.2d 534 (1982). Plaintiffs have not demonstrated that Pfizer acted
“under the color of law” such that it can be held liable for the Nigerian government's alleged violation of
the “law of nations.”
* * * * * * * * * * * * *
Plaintiffs' allegations paint a vivid picture of the unspeakable pain and suffering of dozens of innocent
children. The issue on this appeal, however, is not whether Pfizer's alleged conduct was “wrong,” or
even whether it is legally actionable, but whether it falls within both the “narrow class” of international
norms for which ATS jurisdiction exists, and the even smaller subset of those norms actionable against
non-state actors. Our Court and the Supreme Court have made it pellucidly clear that ATS jurisdiction
must be reserved only for acts that the nations of the world collectively determine interfere with their
formal relations with one another-including those rare acts by private individuals that are so serious as
to threaten the very fabric of peaceful international affairs. I cannot agree with my colleagues that
Pfizer's alleged conduct poses the same threat or is so universally and internationally proscribed as to fit
within that narrow class.
I respectfully dissent.
FOOTNOTES
1. Bacterial meningitis is a serious and sometimes fatal infection of the fluids surrounding the spinal
cord and the brain. Centers for Disease Control and Prevention, Meningococcal Disease: Frequently
Asked Questions (May 28, 2008), http://www.cdc.gov/meningitis/bacterial/faqs.htm.
2. The appellants further allege that Pfizer failed to follow its protocol in ways that might have
mitigated the harm suffered by the children. They contend that Pfizer violated the protocol by
administering Trovan orally even though oral absorption is difficult for sick children; conducting no
testing prior to administering the drug to determine whether Nigeria's strain of meningitis might be
responsive to Trovan; failing to determine that the children in the test had meningitis; and failing to
either exclude from the experiment children with liver or joint problems or to test for such problems,
even though Trovan was known to exacerbate them. Although Pfizer's protocol called for children
receiving Trovan to be switched to Ceftriaxone if they did not respond well to Trovan, Pfizer allegedly
did not conduct regular blood tests of the children or switch those who suffered from Trovan-related
side effects to Ceftriaxone.
3. A Nigerian physician who was the principal investigator for the test allegedly admitted that his
office created the backdated approval letter when the FDA conducted an audit of the experiment in
1997.
4. Tina Akannam, Nigeria: Pfizer-Case Adjourned Till May 27, Vanguard, April 30, 2008, http://all
africa.com/stories/200804300470.html; Joe Stephens, Pfizer Faces Criminal Charges in Nigeria, The
Washington Post, May 30, 2007, at A10, available at http://www.washingtonpost.com/wp-dyn/content/
article/2007/05/29/AR2007052902107.html.
5. Jonathan Clayton, Pfizer Under Fire After Drug Trial, TimesOnline, June 27, 2007, http://business.
timesonline.co. uk/tol/business/industry_sectors/health/article 1990908.ece; Nigeria Sues Drugs Giant
Pfizer, BBC News, June 5, 2007, http://news.bbc.co. uk/2/hi/africa/6719141.stm.
6. Twombly instituted a flexible “plausibility standard,” not limited to antitrust cases, which requires
the amplification of facts in certain contexts. Iqbal v. Hasty, 490 F.3d 143, 155-58 (2d Cir.2007).
7. These sources are located respectively at (1) United States v. Brandt, 2 Trials of War Criminals
Before the Nuremberg Military Tribunals Under Control Council Law No. 10, 181 (1949) [hereinafter
Nuremberg Trials]; (2) World Med. Ass'n, Declaration of Helsinki: Ethical Principles for Medical
Research Involving Human Subjects, art. 20, 22, G.A. Res. (adopted 1964, amended 1975, 1983, 1989,
1996, and 2000), http://www. wma.net/e/policy/pdf/17c.pdf [hereinafter Declaration of Helsinki]; (3)
Council for International Organizations of Medical Services [CIOMS], International Ethical Guidelines for
Biomedical Research Involving Human Subjects, guideline 4 (3rd ed.2002), superseding id. at guideline 1
(2nd ed.1993); (4) International Covenant on Civil and Political Rights, art. 7, Dec. 19, 1966, 999 U.N.T.S.
171 [hereinafter ICCPR].
8. The district court interchangeably refers to the “lack of jurisdiction” or “lack of subject matter
jurisdiction” over plaintiffs' claims, the plaintiffs' failure to state an ATS claim, and their failure to
identify a norm that permits the inference of a cause of action.
9. The Fourth Geneva Convention, which entered into force in 1950 and provides protection to
civilians in the time of war, elaborates on the application of the norm during armed conflict. Article 32
of the convention prohibits civilian or military agents of the state parties from conducting “medical or
scientific experiments not necessitated by the medical treatment of the protected person.” Geneva
Convention Relative to the Protection of Civilian Persons in Time of War art. 32, Aug. 12, 1949, 6 U.S.T.
3516, 75 U.N.T.S. 287. According to the commentary, “[p]rotected persons must not in any
circumstances be used as ‘guinea pigs' for medical experiments.” Commentary on the Geneva
Conventions of 12 August 1949: IV Geneva Convention Relative to the Protection of Civilian Persons in
Time of War 224 (Oscar Uhler & Henri Coursier eds., 1958). This commentary explains that the
prohibition is directly related to the first principle of the Nuremberg Code since “[i]n prohibiting medical
experiments on protected persons, the Diplomatic Conference wished to abolish for ever the criminal
practices from which thousands of persons suffered in the death camps of the [second] world war.”
The practices involved human medical experiments that were objectionable because they were
nonconsensual. See Brandt, 2 Nuremberg Trials, at 183. The convention is legally-binding on 194
states that have ratified it without reservation to Article 32. See International Committee of the Red
Cross, Geneva Conventions of 12 August 1949 State Parties, Signatories, Reservations and Declarations,
http://www.icrc.org/ihl.nsf/WebSign?ReadForm & id=375 & ps=P.
10. Although certain States-Parties to the ICCPR have made reservations or declarations with respect
to Article 7's prohibition of torture and cruel, inhuman or degrading treatment or punishment, we are
not aware of any similar qualification by a State-Party to the prohibition of medical or scientific
experimentation without the free consent of human subjects. See Office of the United Nations High
Commissioner for Human Rights, International Covenant on Civil and Political Rights, Declarations and
Reservations, http://www2.ohchr. org/english/bodies/ratification/docs/Declarations
ReservationsICCPR.pdf.
11. Khulumani makes clear that treaties that the United States has neither signed nor ratified-let
alone treaties like the ICCPR that the United States has signed but not ratified-may evidence a
customary international law norm for ATS purposes where the treaty has been ratified widely and it is
clear that the reason for the United States's failure to subscribe to the treaty was unrelated to the
particular norm in question. See Khulumani, 504 F.3d at 276, 276 n. 9 (Katzmann, J., concurring).
12. The Department of Health and Human Services has compiled the laws, regulations, and guidelines
governing human subjects research in eighty-four countries. See Office of Human Research Prot., Dep't
of Health & Human Servs., International Compilation of Human Subject Research Protections (2008),
http://www.hhs.gov/ohrp/international/HSPCompilation. pdf. It is uncontested that all of the countries
identified in this compilation require informed consent to medical experimentation.
13. The importance of informed consent to medical experimentation was reinforced with the passage
of the National Research Act in 1974, which established the National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research. See National Research Act, Pub.L. 93-348, 88
Stat. 342 (codified as amended in scattered sections of 42 U.S.C.). This body issued the Belmont
Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research in 1979,
which identifies basic ethical principles governing biomedical and behavioral research on human
subjects and requires informed consent. Nat'l Comm'n for the Prot. of Human Subjects of Biomedical
& Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of
Human Subjects of Research, part C(1) (1979), available at http://ohsr.od. nih.gov/guidelines/belmont.
html# goc. Soon afterwards, the Department of Health, Education and Welfare (later renamed the
Department of Health and Human Services) promulgated stricter regulations for ensuring informed
consent in research conducted or supported by federal departments or agencies. See U.S. Dep't of
Health & Human Servs., Guidelines for the Conduct of Research Involving Human Subjects at the
National Institutes of Health, 17-18 (5th ed.2004), http://ohsr.od.nih.gov/guidelines/GrayBooklet
82404.pdf (referencing 45 C.F.R. pt. 46, subpt. A (1981)).
14. States-Parties to the Convention on Human Rights and Biomedicine are also required to afford
“appropriate judicial protection” to prevent or end infringements of the rights protected by the
Convention, including the right to informed consent to medical experimentation. Convention on
Human Rights and Biomedicine, supra, at art. 23.
15. At the fringe, disagreement exists over certain aspects of informed consent including, for
example, the way to best secure consent from illiterate or otherwise vulnerable populations, see, e.g.,
Daniel W. Fitzgerald et al., Comprehension During Informed Consent in a Less-Developed Country, 360
The Lancet 1301, 1301-02 (2002), and whether informed consent is possible in double-blind experiments
in which some subjects are given placebos, see, e.g., Timothy S. Jost, The Globalization of Health Law:
The Case of Permissibility of Placebo-Based Research, 26 Am. J.L. & Med. 175, 183-86 (2000). These
debates do not disturb the specificity of the basic norm at issue or the unanimity of world opinion
against medical experimentation on human subjects without their consent.
16. In the United States, for example, the number of foreign clinical investigators conducting drug
research under an IND increased sixteen-fold in the 1990s. Globalization of Clinical Trials, supra, at 6.
17. These benefits are well acknowledged. See, e.g., Remigius N. Nwabueze, Ethical Review of
Research Involving Human Subjects in Nigeria: Legal and Policy Issues, 14 Ind. Int'l & Comp. L.Rev. 87,
102 (2003) (recognizing that clinical trials at times provide the only access to innovative and effective
health care in developing countries); David Wendler, et al., The Standard of Care Debate: Can Research
in Developing Countries Be Both Ethical and Responsive to those Countries' Health Needs?, 94 Am. J.
Pub. Health 923, 923 (2004) (noting dramatic inequalities in health care world-wide and the potential of
drug research to better care for the world's poor).Doctors Without Borders, the WHO, and other
international health organizations, for example, have called for increased corporate research interest in
developing countries. Sonia Shah, Globalizing Clinical Research, The Nation, June 13, 2002, at 3, http://
www.thenation. com/doc/20020701/shah. Ruth Faden, a bioethicist at Johns Hopkins, stated, “What
we need, if anything, is more health research in the developing world, not less.” Id. An HIV researcher
observed that even when companies test drugs geared for patients in the developed world through
trials in developing countries, the testing “brings benefits to the patients. They get special attention
and potential therapy.” Id.
18. Salisu Rabiu, Pfizer Asks Nigeria Court to Dismiss Case, The Associated Press, July 4, 2007, http://
origin.foxnews.com/printer_friendly_ wires/2007Jul04/0,4675,NigeriaPfizer,00.html (reporting that the
boycott of the Kano polio vaccination program is believed to have “set back global eradication” of polio
and to have “caus[ed] an outbreak that spread the disease across Africa and into the Middle East”).
The boycott also impaired the efforts of American pharmaceutical companies to contribute to polio
eradication by donating over 130 million doses of polio vaccine to sixteen African countries since 1997.
PhRMA, Global Partnerships: Humanitarian Programs of the Pharmaceutical Industry in Developing
Nations 4 (2004), http://www.phrma.org/files/Global_Partnerships_2004.pdf.
19. World Health Organization, Poliomyelitis in Nigeria and West/Central Africa, June 18, 2008,
http://www.who.int/csr/don/2008_06_ 18/en/.Other examples of the link between the cross-border
spread of contagious disease and international peace and stability come to mind, such as the outbreak
of anti-U.S. riots in South Korea as a result of fear that imported American beef will spread mad cow
disease to that country. See Choe Sang-Hun, South Korea Lifts Ban on U.S. Beef, New York Times, June
26, 2008, http://www.nytimes.com/2008/06/26/world/asia/26korea.html.
20. FDA data suggests the industry trend is to use foreign research to support applications for new
drug approvals in the United States. Since 1990 there has been an explosion in the number of foreign
clinical investigators conducting drug research that sponsors use for this purpose. In 1990, there were
271 foreign investigators conducting research in 28 countries in the FDA database. By 1999, the
number had grown to 4,458 investigators working in 79 countries. Globalization of Clinical Trials,
supra, at i.
1. Even if we were to conclude that such a norm applied to state actors and that private entities could
be held liable if they act under color of law, Plaintiffs have not pleaded sufficient state involvement to
impose liability on Pfizer under that theory. See Part III infra.
2. Article 5-General ruleAn intervention in the health field may only be carried out after the person
concerned has given free and informed consent to it. This person shall beforehand be given appropriate
information as to the purpose and nature of the intervention as well as on its consequences and risks.
The person concerned may freely withdraw consent at any time.
4. Reliance on states' domestic laws also raises questions of mutuality, discussed infra at Part II.
5. “Crimes Against Peace” were defined as “planning, preparation, initiation or waging of a war of
aggression, or a war in violation of international treaties, agreements or assurances, or participation in a
common plan or conspiracy for the accomplishment of any of the foregoing.” Charter of the
International Military Tribunal art. 6(a).
6. “War Crimes” were defined as “violations of the laws or customs of war. Such violations shall
include, but not be limited to, murder, ill-treatment or deportation to slave labor or for any other
purpose of civilian population of or in occupied territory, murder or ill-treatment of prisoners of war or
persons on the seas, killing of hostages, plunder of public or private property, wanton destruction of
cities, towns or villages, or devastation not justified by military necessity.” Charter of the International
Military Tribunal art. 6(b).
7. “Crimes Against Humanity” were defined as “murder, extermination, enslavement, deportation,
and other inhumane acts committed against any civilian population, before or during the war; or
persecutions on political, racial or religious grounds in execution of or in connection with any crime
within the jurisdiction of the Tribunal, whether or not in violation of the domestic law of the country
where perpetrated.” Charter of the International Military Tribunal art. 6(c).
8. In addition to the three crimes listed in the Charter of the International War Tribunal, Control
Council Law No. 10 added a fourth-“Membership in categories of a criminal group or organization
declared criminal by the International Military Tribunal.” Control Council Law No. 10 art. II, § (d).
9. The majority purports to include our recent decision in Khulumani v. Barclay National Bank Ltd.,
504 F.3d 254 (2d Cir.2007) (per curiam) in this select group, stating that it “held that the ATS conferred
jurisdiction over multinational corporations that purportedly collaborated with the government of South
Africa in maintaining apartheid because they aided and abetted violations of customary international
law.” Maj. Op. at 174. To the contrary, Khulumani did not confer jurisdiction and did not make any
determination on whether plaintiffs had stated a violation of international law. It merely held that the
district court erred in concluding that the ATS did not convey jurisdiction for “aiding and abetting
violations of customary international law,” and remanded for consideration of whether plaintiffs had
alleged such a violation that the defendants could have been liable for aiding and abetting. See
Khulumani, 504 F.3d at 260.
10. Indeed, the Supreme Court later declared that in ATS actions, “federal courts should give serious
weight to the Executive Branch's view of the case's impact on foreign policy.” Sosa, 542 U.S. at 733 n.
21, 124 S.Ct. 2739.
11. Section 702 provides:A state violates international law if, as a matter of state policy, it practices,
encourages, or condones(a) genocide,(b) slavery or slave trade,(c) the murder or causing the
disappearance of individuals,(d) torture or other cruel, inhuman, or degrading treatment or
punishment,(e) prolonged arbitrary detention,(f) systematic racial discrimination, or(g) a consistent
pattern of gross violations of internationally recognized human rights.
12. The Court explained its application of a criminal law provision to a civil statute by noting that a
comment to section 404 “permits states to establish appropriate civil remedies such as the tort actions
authorized by the [ATS].” Kadic, 70 F.3d at 240 (citation omitted). More specifically, “jurisdiction on
the basis of universal interests has been exercised in the form of criminal law, but international law does
not preclude the application of non-criminal law on this basis, for example, by providing a remedy in tort
or restitution for victims of piracy.” Restatement (Third) § 404 cmt. b.
13. Yousef was charged with placing a bomb aboard a Philippine Airlines jet flying from the
Philippines to Japan. 327 F.3d at 81, 88. After holding that customary international law could not
support universal jurisdiction, we observed that “treaties may diverge broadly from customary
international law,” id. at 108, and upheld jurisdiction under 18 U.S.C. § 32, the statute implementing
the “extradite or prosecute” provision of the Montreal Convention for the Suppression of Unlawful Acts
Against the Safety of Civil Aviation (Sabotage) art. 7, Sept. 23, 1971, 24 U.S.T. 565, 974 U.N.T.S. 177
(“The Contracting State in the territory of which the alleged offender is found shall, if it does not
extradite him, be obliged, without exception whatsoever and whether or not the offence was
committed in its territory, to submit the case to its competent authorities for the purpose of
prosecution.”), id. at 108-10.
14. I note the tension between our holding in Bigio that acts can, at least in theory, be incorporated
into § 404 by analogy for ATS purposes, see 239 F.3d at 448, and our statement in Yousef that the
“strictly limited set of crimes subject to universal jurisdiction cannot be expanded by drawing an analogy
between some new crime ․ and universal jurisdiction's traditional subjects” for purposes of exercising
criminal jurisdiction, see 327 F.3d at 103-04.
15. It should be noted that while universal criminal jurisdiction under the CAT does exist for torturers,
those torturers must, by definition, be state actors. See CAT arts. 4, 7, 8.
16. See, e.g., United Nations Convention on the Law of the Sea part VII, art. 101, Dec. 10, 1982, S.
Treaty Doc. No. 103-39, 1833 U.N.T.S. 3 (stating that piracy may consist of “any illegal acts of violence or
detention, or any act of depredation․”)
17. All but three of the 23 defendants were doctors. 1 Trials of War Criminals 29. The three that
were not were colonels or senior colonels in the Nazi SS. 1 Trials of War Criminals 8, 29. Of the 20
doctors, all but one “held positions in the medical services of the Third Reich.” 1 Trials of War
Criminals 29. The lone exception, Adolf Pokorny, a specialist in skin and venereal diseases, was
acquitted of all charges. 1 Trials of War Criminals 10; 2 Trials of War Criminals 292-94.
18. Plaintiffs also initially allege that the government backdated a letter of approval for the test, but
then allege that the letter was in fact created by a “Nigerian physician whom Pfizer says was its principal
investigator.”
19. The case relied upon by the district court is entirely distinguishable. See Nat'l Coal. Gov't of the
Union of Burma v. Unocal, Inc., 176 F.R.D. 329 (C.D.Cal.1997). There, plaintiffs survived a motion to
dismiss by alleging that Unocal and the Burmese government were joint venturers and partners in a
pipeline, with the Burmese government retaliating against protesters with military action and forced
labor imposed by the Burmese military with Unocal's knowledge. Id. at 348. There, as opposed to
here, the state committed the unlawful acts.