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Second Circuit lets Nigerian children's drug case proceed in U.S.

Article Excerpt
A case alleging that dozens of Nigerian children were harmed or killed by a clinical drug trial may go forward in the U.S. court system, the Second Circuit has held. The plaintiffs allege that Pfizer, Inc.'s trial of its antibiotic Trovan led to 11 deaths and caused blindness, deafness, paralysis, and brain damage in many other children.

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More than 80 families filed suit under the Alien Tort Statute (ATS), alleging that the company violated international law that prohibits medical experiments on people without their consent. The district court dismissed the case. The Second Circuit reversed that decision and remanded the case for further proceedings. (Abdullahi v. Pfizer, Inc., 2009 WL 214649 (2d Cir. Jan. 30, 2009).)

Pfizer never got consent--oral or written, in English or Hansa, the participants' native language--from the children or their parents or guardians, the plaintiffs argued. Instead, the families thought they were getting "volunteer relief" from Pfizer. The company maintains that Nigerian nurses obtained oral consent in Hausa.

The plaintiffs contend that Pfizer collaborated with the Nigerian government to exploit the local population. "The people who participated had no idea it was an experiment," said New York lawyer Peter Safirstein, who represents some of the families.

The FDA approved Trovan for adults in 1998, but after reports of liver failure, the agency issued a public health advisory in 1999, telling doctors to use it only on patients who meet certain criteria. The European Union banned the drug in 1999.

Testing Trovan

In 1996, seeking FDA approval of Trovan, Pfizer went to a rudimentary hospital in Kano, Nigeria, to test it during an epidemic of bacterial meningitis. Pfizer claimed to have approval for the trial from a hospital ethics committee, but Nigerian officials working at the hospital backdated...

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