Harbinger of Informed Consent Parity?: Abdullahi v. Pfizer and the Alien Torts Statute
by Stacey B. Lee, J.D.
Currently pending before the United States Supreme Court is Pfizer’s appeal in Abdullahi v. Pfizer, Inc. At issue is the applicability of the Alien Tort Statute (ATS) as the basis for jurisdiction over alleged violations of customary international law committed by Pfizer in Nigeria. The appeal will determine whether non-consensual medical experimentation violates the law of nations, and, therefore, U.S. law. The lawsuit is also the first filed in the United States against an American-based pharmaceutical corporation for conduct involving medical experiments on residents of a developing world country. The facts giving rise to this lawsuit began in Nigeria.
In 1996, an epidemic of bacterial meningitis broke out in Kano, Nigeria. In the midst of the outbreak, Pfizer requested and received approval from the Nigerian government to enter the country and conduct clinical trials on the children infected with meningitis. Pfizer selected 200 children between the ages of one and thirteen for the trial. The plaintiffs allege that during the phase three clinical trial, half of the children were administered Trovan while the other half received the FDA-approved antibiotic Ceftriaxone. Plaintiffs further alleged that Pfizer purposely low-dosed the children in the Ceftriaxone group in order to misrepresent the effectiveness of Trovan in comparison to Ceftriaxone. The Trovan Pfizer administered on the children had not received FDA approval or been tested on children in its oral form. In addition, animal testing indicated that Trovan had life-threatening side effects, including liver disease, abnormal cartilage growth, and joint disease.
Pfizer conducted the tests over a two-week period. At the conclusion of the clinical trial, Pfizer allegedly left without providing any follow-up care. Shortly thereafter, Pfizer submitted the clinical data to the FDA and Trovan subsequently received FDA approval. Within its first year, Trovan generated over 160 million dollars in revenue.
In August 2001, a group of Nigerian minors and their guardians filed a class action lawsuit against Pfizer under the ATS. The statute provides that “the 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.” The central allegation was 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.” The plaintiffs further alleged that Pfizer failed to inform them of the immediate availability of alternative medically appropriate treatment from Doctors without Borders in the same facility. Finally, plaintiffs claim that Pfizer’s drug trial led to the deaths of eleven children and serious injuries to many others.
After years of litigation, in January 2009, the Second Circuit determined that conducting medical experiments on human subjects without their consent violates customary international law. The court next applied the standard articulated by the Supreme Court in Sosa v. Alvarez-Machain to determine whether the conduct was actionable under the ATS. In Sosa, the Court held that ATS jurisdiction is limited to alleged violations of international norms that are: (1) universal and obligatory, (2) comparable to the 18th century paradigms that existed when the ATS was enacted, and (3) followed by States “out of a sense of legal obligation and mutual concern.” The Court also noted that these criteria set a “high bar to new private causes of action” and advised lower courts to be cautious in determining whether a category of actions meets those criteria.
The Second Circuit found the prohibition on non-consensual human medical experimentation was accepted by nations around the world largely without exception. The court noted this universality of consensus beginning with the Nuremberg Code. The court then traced the evolution of the prohibition into a norm of customary international law by referencing several sources of international law. The court concluded that international sources such as: the International Convents on Human Rights, the World Medical Associations’ Declaration of Helsinki, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Uses’ Good Clinical Practice guidelines, the European Union’s 2001 Clinical Directive, the Council of Europe’s Convention of Human Rights and Biomedicine illustrate that the norm prohibiting non-consensual medical experimentation on human subjects has become firmly embedded in the international community as a universal norm. Moreover, the court noted that eighty-four countries, including the United States, have national laws and regulations requiring human subjects’ informed consent.
The court also held that the norm prohibiting non-consensual human medical experimentation is specific in its requirement and of mutual concern to States. The court noted that an important component of the “mutual concern” criteria is showing the questioned conduct is capable of impairing international peace and security. The court concluded that administering drug trials in other countries without informed consent “fosters distrust and resistance” and jeopardizes the global use of essential medicine that can help reduce the spread of contagious disease. As evidence, the court recounted the catastrophic results of the 2004, Kano polio vaccine boycott. Because of rumors of Pfizer’s alleged conduct in the Trovan clinical trial, for eleven months the local population refused international and national efforts to inoculate them with the polio vaccine. The Nigerian polio outbreak caused an international outbreak that spread the disease to twenty previously polio-free countries. The court concluded its analysis by holding that the plaintiffs had plead sufficient facts to sustain a cause of action under ATS for violating the international norm prohibiting non-consensual medical experimentation on human subjects. Pfizer appealed the decision to the Supreme Court.
The pending appeal presents an opportunity for the Supreme Court to solidify the ATS’ jurisdictional reach over international human rights violations. In addition, it would extend the reasoning articulated by the Second Circuit, and affirmed by the Supreme Court, in Khulumani v. Barclay National Bank Ltd. (The Supreme Court lacked the necessary quorum to review the case). In Khulumani, the Second Circuit applied the ATS to apartheid–related claims of South African citizens against more than 50 multinational corporations that allegedly collaborated with the South African government to perpetuate the system of apartheid. In reversing the district court’s dismissal, the Second Circuit explicitly held that “in this Circuit a plaintiff may plead a theory of aiding and abetting liability under the [ATS]” for such international human rights violations. This holding signifies an important evolution of the applicability of ATS as a tool in advancing universal rules of law condemning human rights abuses. In addition, by affirming the decision, the Supreme Court signaled that violators of these rights could be held accountable for their participation and be required to provide victims with direct relief.
Building on that foundation, Abdullahi provides the opportunity to apply the ATS to address abuses that arise from the disparity in informed consent protections afforded human subjects in clinical trials conducted domestically and abroad. Over the past decade, clinical trials have increasingly moved to developing countries. Key factors in this relocation are large pools of willing foreign participants and less burdensome regulatory requirements -- including human subject protections. The absence of robust protections can create an environment where abuses similar to those alleged in Abdullahi can occur. In order to reduce that possibility, the FDA recently strengthened the regulations regarding sponsor responsibilities in conducting foreign clinical trials. Notwithstanding these changes, there is still not parity between informed consent protections for clinical trials conducted domestically and for those abroad. Moreover, the United States has not ratified the international laws or codes that would bridge the gap in those protections. In Abdullahi, the Supreme Court has an opportunity to establish parity with human rights protections afforded to human subjects within the United States and recognized throughout the world. The Court could determine once and for all that informed consent for human medical experimentation is a norm of customary international law and enforceable under the ATS. In doing so, the Court could articulate a legally enforceable framework for a foreign country’s nationals to pursue human rights violations in the context of clinical trials.