(CN) – The 2nd Circuit reinstated two lawsuits accusing Pfizer of testing an experimental antibiotic on Nigerian children, causing the deaths of 11 children and leaving others blind, deaf, paralyzed or brain-damaged. The court allowed a group of unwitting test subjects and their families to sue the world’s largest pharmaceutical company for allegedly violating a customary international law banning involuntary medical experimentation on humans. The plaintiffs said Pfizer knew that its antibiotic, Trovan, had produced life-threatening side effects on lab animals.
In two federal lawsuits, the plaintiffs claimed that Pfizer sent three physicians to Africa to give Nigerian children doses of its new antibiotic Trovafloxacin Mesylate, or “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. The trials occurred in 1996, during an epidemic of bacteria meningitis in northern Nigeria. Half of the patients were given Trovan, while the other half received Ceftriaxone, an FDA-approved antibiotic. The plaintiffs said Pfizer knew the results could be dangerous, because 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. Test subjects said researchers failed to offer or read them informed-consent documents in English or Hausa, their native language. U.S. District Judge William H. Pauley had 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 report that the Trovan trials engendered so much distrust in the local community that they contributed to an 11-month boycott of a polio vaccination campaign in 2004. The federal judge 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. But the 2nd Circuit said 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 had made their case for such a norm, and could proceed with their lawsuits against Pfizer. 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.” Attorney Peter Safirstein of Milberg LLP, one of the firms representing the plaintiffs, called the ruling “an important decision that makes it clear that multinational pharmaceutical corporations cannot act with impunity in conducting medical testing without informed consent in Third World countries. “Companies such as Pfizer, in conducting these types of medical experiments, must adhere to basic principles of customary international law,” Safirstein wrote. He said the ruling is also important because it “helps clarify the application of the Alien Torts Statute.” Attorneys for Pfizer at Kaye Scholer LLP said they were confident that the drug company “will prevail in these cases.” “The appeals court’s divided decision is only a procedural ruling that may return the cases to the district court for further consideration; it is not a determination of the merits,” according to a statement released by Pfizer. “Indeed, the strong dissent by one of the judges may be grounds for further appellate proceedings.” Pfizer added that the Trovan clinical study “was conducted with the approval of the Nigerian government, and consent of the participants’ parents or guardians, and was consistent with both international and Nigerian laws.” The drug company attributed the deaths and injuries to the meningitis epidemic, not Trovan. “With a survival rate of 94.4 percent, Trovan helped save lives and was at least as effective as the best treatment available at Kano’s Infectious Disease Hospital,” Pfizer’s statement said. “For patients who did not participate in the Trovan investigative study, the survival rate was slightly less than 90 percent.” Pfizer’s attorneys said they’re contemplating how best to respond to the decision.