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The plaintiffs said Pfizer sent three physicians to Africa to give Nigerian children doses of its new antibiotic, Trovan. The doctors allegedly teamed up with Nigerian officials and recruited 200 sick children at Nigeria's Infectious Disease Hospital in Kano to receive the experimental drug.
Half of the patients were given Trovan, while the other half received Ceftriaxone, an FDA-approved antibiotic.
The plaintiffs say Pfizer knew that the results could be dangerous, as animal tests showed that the antibiotic had life-threatening side effects, including joint disease, abnormal cartilage growth, liver damage and a degenerative bone condition.
"After approximately two weeks, Pfizer allegedly concluded the experiment and left without administering follow-up care," the ruling states. "According to the appellants, the tests caused the death of 11 children, five of whom had taken Trovan and six of whom had taken the lowered dose of Ceftriaxone, and left many others blind, deaf, paralyzed, or brain-damaged."
Pfizer allegedly failed to obtain the informed consent of either the children or their parents, and "specifically failed to disclose or explain the experimental nature of the study or the serious risks involved," Judge Parker summarized.
U.S. District Judge William H. Pauley dismissed the claims for lack of subject matter jurisdiction under the Alien Tort Statute and, alternatively, on the ground that U.S. courts were not the most convenient forum.
The federal appeals court in New York reversed on a 2-1 vote, disagreeing with Pauley's conclusion that the prohibition against human experimentation can't be enforced through the Alien Tort Statute.
"The administration of drug trials without informed consent poses threats to national security by impairing our relations with other countries," Judge Parker wrote. The judge cited an Associated Press finding that the Trovan trials engendered so much distrust in the local population that they contributed to an 11-month boycott of a polio vaccination campaign in 2004.
Judge Pauley had acknowledged the international law norm, but concluded that it wasn't legally binding on the United States, because no single source or treaty had officially recognized it.
The 2nd Circuit said the courts must look to a variety of sources to determine whether an international norm is "sufficiently specific, universally accepted, and obligatory for courts to recognize a cause of action to enforce the norm."
Judge Parker said the plaintiffs made their case for such a recognized norm.
Judge Wesley dissented, saying the majority had "undertaken to define a 'firmly established' norm of international law, heretofore unrecognized by any American court or treaty obligation, on the basis of materials inadequate for the task."
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