Abdullahi v. Pfizer Inc

562 F.3d 163 (2009)

Facts

In 1996, during a bacterial meningitis epidemic in northern Nigeria, Pfizer, seeking FDA approval for its experimental antibiotic Trovan for use on children, dispatched a team of American and Nigerian doctors to the Infectious Disease Hospital in Kano. Without obtaining informed consent from the children or their guardians, Pfizer allegedly tested Trovan on 200 sick children, administering it to half and a deliberately low dose of the established antibiotic Ceftriaxone to the other half as a control. Pfizer knew Trovan had never previously been tested on children in the form being used and had shown life-threatening side effects in animal tests, including joint disease, abnormal cartilage growth, liver damage, and a degenerative bone condition. The experiment lasted about two weeks, after which Pfizer left without follow-up care, resulting in the deaths of 11 children—five from Trovan and six from the low-dose Ceftriaxone—and leaving others with disabilities such as blindness, deafness, paralysis, or brain damage. Pfizer allegedly failed to disclose the experimental nature, risks, or alternatives like free treatment from Doctors Without Borders at the same site, and backdated an ethics approval letter with Nigerian officials' help.

Nigerian children and their guardians affected by the tests, including Rabi Abdullahi and others in one group and Ajudu Ismaila Adamu and others in another, sued Pfizer in U.S. federal courts. The Abdullahi plaintiffs claimed violations of the Alien Tort Statute (ATS) for breaching customary international law against nonconsensual human medical experimentation. The Adamu plaintiffs asserted similar ATS claims plus violations of the Connecticut Unfair Trade Practices Act (CUTPA) and Connecticut Products Liability Act (CPLA). The cases were consolidated in the Southern District of New York after transfer. The district court dismissed both for lack of ATS jurisdiction and alternatively on forum non conveniens grounds, applying Nigerian law to bar the state claims in Adamu. Plaintiffs appealed the dismissals.

Subsequently, Nigerian authorities filed separate suits against Pfizer for billions in damages and restitution, none of which sought compensation for the test subjects (these plaintiffs), prompting Pfizer to withdraw its forum non conveniens defense on appeal.

Analysis

Issue #1

Issue

Does the prohibition against nonconsensual medical experimentation on humans constitute a norm of customary international law that is sufficiently specific, universal, and obligatory to support a cause of action under the Alien Tort Statute?

Legal Rule

Under Sosa v. Alvarez-Machain, courts may recognize ATS claims for violations of customary international law norms that are specific, universal, and obligatory, comparable to 18th-century paradigms like piracy; such norms are discerned from sources including international conventions, custom, general principles of law, and judicial decisions, and must be of mutual concern to states.

Rule Analysis

The court examined sources like the Nuremberg Code, ICCPR Article 7, Declaration of Helsinki, and domestic laws of at least eighty-four countries, finding the norm originated at Nuremberg trials and evolved into a universally accepted prohibition through treaties, declarations, and state practices. It determined the norm is universal, as states worldwide prohibit it without exception, binding on private actors, and evidenced by international accords and U.S. regulations incorporating Nuremberg principles. The norm's specificity matches Sosa's paradigms, clearly prohibiting large-scale nonconsensual testing as alleged, not routine negligence. It addresses mutual concerns by threatening international health initiatives, peace, and security, as shown by distrust from the Trovan trials contributing to polio outbreaks and anti-American sentiment.

Conclusion

Yes, the prohibition is a norm of customary international law enforceable under the ATS. The district court erred in requiring explicit binding sources or private rights of action; plaintiffs adequately pled a violation.

Issue #2

Issue

Have plaintiffs sufficiently alleged that Pfizer acted under color of state law for purposes of ATS liability?

Legal Rule

Private actors are liable under the ATS if they acted in concert with the state, under standards akin to 42 U.S.C. § 1983 state action, requiring a close nexus such as joint activity with state officials or significant state aid.

Rule Analysis

Plaintiffs alleged the Nigerian government facilitated the tests by providing a letter to the FDA, accommodations, exclusive hospital access, and staff, while Nigerian officials helped conduct the experiments and cover them up by backdating approvals and silencing critics. These allegations showed Pfizer and Nigerian authorities jointly administered the nonconsensual tests in a state facility, meeting the state action test at the pleading stage.

Conclusion

Yes, plaintiffs sufficiently alleged state action through Pfizer's concerted efforts with Nigerian officials. The complaints plead a close nexus making Pfizer's conduct attributable to the state.

Issue #3

Issue

Did the district court properly dismiss the claims on forum non conveniens grounds?

Legal Rule

Forum non conveniens dismissal requires a three-step analysis under Iragorri v. United Technologies Corp.: deference to plaintiff's forum choice, adequacy of an alternative forum, and balancing public and private interests; the defendant bears the burden of showing an adequate, available alternative forum that tilts factors heavily in its favor.

Rule Analysis

The district court found Nigeria adequate but improperly placed the burden on plaintiffs to prove inadequacy, omitting analysis of defendant's persuasion burden and present availability amid new Nigerian suits against Pfizer. Given Pfizer's withdrawal of this defense on appeal and changed circumstances, remand was necessary for reassessment, including proper burden allocation and evidentiary rules.

Conclusion

No, the district court improperly applied the forum non conveniens analysis by misallocating burdens. The case is remanded for further proceedings on this issue in light of developments.

Issue #4

Issue

Did the district court correctly apply Connecticut choice-of-law principles to dismiss the Adamu plaintiffs' state law claims?

Legal Rule

Under Connecticut law, lex loci delicti applies unless it undermines party expectations, state policy, or reason and justice, triggering the Restatement (Second) of Conflict of Laws §§ 6 and 145 'most significant relationship' test, considering factors like injury location, conduct, parties' domiciles, relationship center, and policies of forums.

Rule Analysis

The district court rightly invoked the Restatement but erred by not fully analyzing § 6 factors, such as forum policies, justified expectations, and ease of applying Connecticut law, focusing only on § 145 contacts favoring Nigeria. It overlooked Pfizer's Connecticut-based planning and research, potentially giving Connecticut a stronger interest, and failed to evaluate expectations or policy implications.

Conclusion

No, the district court incompletely applied the 'most significant relationship' test. The dismissal of the CUTPA and CPLA claims is vacated and remanded for further consideration.

Additional Opinions

Wesley, Circuit Judge: Dissent

Judge Wesley dissents, arguing that the majority erroneously recognizes a new norm of customary international law against non-consensual medical experimentation by private actors under the Alien Tort Statute (ATS), based on inadequate sources. He agrees with the majority's three criteria for ATS jurisdiction—specificity, universality out of legal obligation, and mutual concern—but disagrees that the norm meets the universality or mutual concern requirements. Wesley contends the majority's sources, including the ICCPR (which applies only to states and was deemed of little utility by the Supreme Court in Sosa), regional conventions like the Council of Europe's Convention (not universally ratified and post-dating the events), private declarations (e.g., Declaration of Helsinki, not binding per circuit precedent), domestic laws (irrelevant without international accords), and the Nuremberg Code (a subsidiary judicial decision), fail to establish a universal, obligatory norm applicable to private actors. He emphasizes that international law norms must consider the perpetrator's identity, and here, no such norm extends to corporations like Pfizer. He proposes no new rule but stresses adherence to 'vigilant doorkeeping' from Sosa, requiring norms comparable to historical paradigms like piracy or genocide. Wesley argues the norm is not a matter of mutual concern, as it does not threaten serious international consequences like assaults on ambassadors or piracy; potential distrust leading to disease spread is insufficient without express international accords. Additionally, even assuming a norm against states, Wesley finds plaintiffs failed to allege Pfizer acted under color of law, as required for private actor liability. Allegations of Nigerian government assistance (e.g., letters, accommodations) do not show joint action in the specific misconduct of non-consensual testing, per § 1983 jurisprudence. Wesley concludes that ATS jurisdiction is improper, as the evidence does not meet the high bar set by precedents like Filartiga and Kadic, and would affirm dismissal.