On June 29th, the United States Supreme Court declined to grant a petition for a writ of certiorari filed by Pfizer Inc. seeking review of a January 2009 decision by the Second Circuit Court of Appeals involving claims brought under the Alien Tort Statute (“ATS”). The Second Circuit’s decision held that Nigerian plaintiffs could properly bring claims against Pfizer under the ATS for “violation of the norm of customary international law prohibiting medical experimentation on human subjects without their consent.” Abdullahi v. Pfizer, Inc., 562 F.3d 163 (2d Cir. 2009). The Second Circuit decision represents that first time that a court has found that the failure to gain informed consent for medical testing is a cognizable claim under the ATS.
The Second Circuit’s decision addressed consolidated appeals in two cases in which plaintiffs allege that Pfizer conducted nonconsensual testing of Trovan, an experimental drug, during a meningitis outbreak in Nigeria in 1996. Eleven children died as a result of their participation in the drug trial. Plaintiffs specifically allege that the testing was done with the involvement of the Nigerian government and that the drug was tested on children without their parents’ informed consent.
In evaluating the current impact of the Pfizer litigation, a 2009 column in the New England Journal of Medicine suggested that the Second Circuit’s decision that domestic tort liability may stem from the failure to secure informed consent in international clinical trials “should help persuade international corporations and researchers alike to take informed consent…much more seriously.”
Companies conducting clinical testing abroad should be very careful to ensure that proper consent is obtained, especially when dealing with patient populations that, because of language barriers or level of education, may not fully comprehend the risks associated with specific trials.
More generally, companies should be aware of the analysis used by the Second Circuit in finding that the international law norm prohibiting nonconsensual medical testing is sufficiently “universal, specific, and obligatory” so as to meet the standard for subject matter jurisdiction under the ATS established in the Supreme Court’s decision in Sosa v. Alvarez-Machain (2004). The court observed that “declarations of international norms that are not in and of themselves binding” may provide evidence as to the current state of customary international law when viewed in conjunction with state practice.
In its determination, the Second Circuit looked to a wide range of international sources cited by plaintiffs including non-binding treaties, declarations by international organizations, and the Nuremberg Code, promulgated by a U.S. military tribunal after the Nuremberg trials. The court found that it is not necessary for these sources of international law to explicitly authorize a cause of action in order to give rise to proper claim under the ATS. This type of analysis may support a wider range of ATS claims that many observers thought would be properly viable after Sosa.