[Courtesy of Alicia Ouellette]
The United States Court of Appeals for the Second Circuit has handed down a case of major importance in research ethics and international law. The case is Rabi Abdullahi v. Pfizer. The plaintiffs are Nigerian children and their families who were subjected to medical experimentation in Nigeria by drug manufacturer Pfizer. Specifically, the children were among two hundred sick children in Nigeria given the experimental antibiotic Trovan as part of a protocol designed to test the efficacy of Trovan against that of a standard antibiotic treatment. The plaintiffs sought, and won, the right to sue Pfizer in federal court for damages caused by Pfizer's involuntary medical experimentation.
The decision is legally significant for its holding that nonconsensual experimentation on humans violates a legally enforceable norm of customary international law. No American court or treaty recognized such a norm before this case. Not surprisingly, the opinion is not unanimous. The dissent accuses the majority of creating "a new norm out of whole cloth [that] misconstrues – rather than vindicates – customary international law."
The opinion can be accessed at this link: http://www.ca2.uscourts.gov:8080/isysnative/RDpcT3BpbnNcT1BOXDA1LTQ4NjMtY3Zfb3BuLnBkZg==/05-4863-cv_opn.pdf#xml=http://www.ca2.uscourts.gov:8080/isysquery/irla125/10/hilite.
The opinion is long, and includes several technical legal issues. But the court's analysis of whether universally accepted and legally enforceable norms of international law prohibit medical experimentation on non-consenting human subjects (which begins in earnest at page 22 of the opinion) breaks new ground in American law. It is worth reading.
[Editor's Note: For articles that give you more background on the Nigeria vs Pfizer Trovan suits, here are links to few: