Lead Opinion
This consolidated appeal is from the judgments of the United States District Court for the Southern District of New York (Pauley, /.) 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 Abdullah! 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
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
A. Pfizer’s Trovan Test in Nigeria
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.,
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
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.
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.
B. The Proceedings Below
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 oí forum non conveniens, conditioned on Pfizer’s consent to litigation in Nigeria. Abdullahi v. Pfizer, Inc., No. 01 Civ. 8118(WHP),
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/
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 CUT-PA, 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,
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,
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.
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,
I. The Alien Tort Statute
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,
In 2004, the Supreme Court comprehensively addressed the ATS for the first time in Sosa v. Alvarez-Machain,
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,
Since Sosa, this Court has reviewed three judgments dismissing claims under the ATS. In Khulumani v. Barclay National Bank, Ltd.,
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.
A The Prohibition of Nonconsensual Medical Experimentation on Humans
Appellants’ ATS claims are premised on the existence of a norm of custom
(a) international conventions, whether general or particular, establishing rules expressly recognized by the contesting states;
(b) international custom, as evidence of a general practice accepted as law;
(c) the general principles of law recognized by civilized nations;
(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.”
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,
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,
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,
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,
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,
i. Universality
The appellants must allege the violation of a norm of customary international law to which States universally subscribe. See Sosa,
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
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 “[manifestly human experiments under such conditions are contrary to the principles of the law of nations as they result from usages established among civilized
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,
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 “[tjhe 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.,
Consistent with this view, the Code’s first principle has endured: “[Significant 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.
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 rеquires 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,
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 & blob-type =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 nonbinding, 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.neUe/ ethicsuniUpdf/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.
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,
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.inV 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.
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
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,
Hi. Mutual Concern
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,
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, non-consensual 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,
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.
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.
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.
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
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,
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
II. Forum Non Conveniens
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.,
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.,
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.,
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,
III. Choice of Law
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,
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 ease had not been transferred from Connecticut to New York. See Van Dusen v. Barrack,
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
(a) the needs of the interstate and international systems,
(b) the relevant policies of the forum,
(c) the relevant policies of other interested states and the relative interests of those states in the determination of the particular issue,
(d) the protection of justified expectations,
(e) the basic policies underlying the particular field of law,
(f) certainty, predictability and uniformity of result, and
(g) ease in the determination and application of the law to be applied.
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,
(a) the place where the injury occurred,
(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,
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.
Notes
. 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.
. 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.
. 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.
. Tina Akannam, Nigeria: Pfizer — Case Adjourned Till May 21, Vanguard, April 30, 2008, http://allafrica.com/stories/2008 04300470.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/contenl/ article/2007/05/29/AR2007052902107.html.
. 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.
. Twombly instituted a flexible "plausibility standard,” not limited to antitrust cases, which requires the amplification of facts in certain contexts. Iqbal v. Hasty,
. 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/pdPFed. Appx.c.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],
. 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.
. 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, "[protected persons must not in any circumstances be used as 'guinea pigs’ for medical experiments.” Commentary on the Geneva Conventions of 12 August 1949: TV Geneva Convention Relative to the Protection of Civilian Persons in Time of
. 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/englisb/bodies/ratification/ docs/Declarations ReservationsICCPR.pdf.
. 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,
. 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.
. 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(l) (1979), available at http://ohsr.od.nih. gov/guidelines/belmonl.html# goc. Soon after-wards, 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)).
. 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.
. 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.
. 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.
. 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 Fa-den, 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.
. 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,Nigeria Pfizer,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.
. World Health Organization, Poliomyelitis in Nigeria and West!Central Africa, June 18, 2008, http://www.who.in1/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.
. 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.
Dissenting Opinion
dissenting:
The majority has undertaken to define a “firmly established” norm of international law, heretofore unrеcognized 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.
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,
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,
In support of its determination that non-consensual medical experimentation by private actors is a matter of mutual concern, the majority reasons that non-consensual medical experiments breed distrust of medical interventions and thereby accelerate the spread of infectious diseases across international borders. It is not enough, however, that tortious conduct could create some sort of international consequence. In order for conduct to be a matter of mutual concern, it must “threaten[ ] serious consequences in international affairs.” Sosa,
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
I. Universal and Legally Obligatory Adherence
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,
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.
A. The Majority’s Sources of Customary International Law
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-identiflable source.
The ability to pick and choose from this seemingly limitless menu of sources presents a real threat of “creative interpretation.” Flores,
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
1. Treaties & Conventions
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.”
The majority relies primarily on two treaties.
a. International Covenant on Civil and Political Rights
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,
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.”
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,
b. Convention on Human Rights and Biomedicine
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
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,
A second, more fundamental problem with the majority’s reliance on the Conven
2. Multinational Declarations of Principle
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, plaintiffs sought to demonstrate customary international law by reference to multinational declarations. In response, we noted that a declaration, “which may be made by a multinational body, or by one or more States, customarily is a ‘mere general statement of policy [that] is unlikely to give rise to ... obligation[s] in any strict sense.’ ”
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
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.”
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,
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.”
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,
4. The Nuremberg Code
The majority centers its analysis around the Nuremberg Code, but, in the process,
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 rеsponsible 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,
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,”
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 con
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,
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,
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.
In those cases, the evidence of international acceptance of each norm with respect to each defendant was “clear and unambiguous.” Flores,
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 § ¿OJ
Nor does Plaintiffs’ purported norm resemble the select few norms for which international law extends liability to private actors. Although the law of nations
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.
Five years later, we again determined whether an international law norm applied only to state actors. See Bigio v. Coca-Cola Co.,
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,
Universal jurisdiction originated with prosecutions of piracy more than 500 years ago. See Yousef,
Their Majesties the Emperor of Austria, the King of Hungary and Bohemia, the King of Prussia, and the Empеror 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 Con-sol. 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,
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.”
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.
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.”).
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,
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,
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,
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,
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,
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,
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,
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,
III. State Action
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,
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,
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 “assigned] Nigerian physicians to assist in the project.”
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
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.,
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,
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,
The case of Beanal v. Freeport-McMoRan, Inc.,
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,
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,
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 “[mjere approval of or acquiescence in the initiatives of a private party is not sufficient to justify holding the State responsible for those initiatives.”
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.
. 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.
. Article 5 — General rule
An 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.
. Article 16 — Protection of persons undergoing research
Research on a person may only be undertaken if all the following conditions are met:
i. there is no alternative of comparable effectiveness to research on humans; ii. the risks which may be incurred by that person are not disproportionate to the potential benefits of the research;
iii. the research project has been approved by the competent body after independent examination of its scientific merit, including assessment of the importance of the aim of the research, and multidisciplinary review of its ethical acceptability;
iv. the persons undergoing research have been informed of their rights and the safeguards prescribed by law for their protection;
v. the necessary consent as provided for under Article 5 has been given expressly, specifically and is documented. Such consent may be freely withdrawn at any time.
. Reliance on states' domestic laws also raises questions of mutuality, discussed infra at Part II.
. "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).
. "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).
. "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).
. 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).
. The majority purports to include our recent decision in Khulumani v. Barclay National Bank Ltd.,
. 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,
. 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 recоgnized human rights.
. 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,
. Yousef was charged with placing a bomb aboard a Philippine Airlines jet flying from the Philippines to Japan.
. 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
. 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.
. 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....”)
. 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 Crimi
. 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.”
. 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.,