October 8

Appeals Court reinstates Nigerian research case against Pfizer

Appeals Court reinstates Nigerian research case against Pfizer

Tue, 14 Oct 2003

On Oct. 8, 2003, The US Court of Appeals for the Second District (NY) vacated and remanded the lower District Court decision (Sept. 26, 2002) that had dismissed a lawsuit brought on behalf of Nigerian children and guardians against Pfizer. The plaintiffs in the case charge the pharmaceutical company with conducting medical experiments in Nigeria on babies and children without parental informed consent.

“The central events at issue in this lawsuit occurred in 1996, not long after epidemics of bacterial meningitis, measles and cholera broke out in Kano, Nigeria. Pfizer established a treatment center at the Infectious Disease Hospital in Kano to treat victims of the meningitis epidemic. Plaintiffs allege that Pfizer, instead of using safe and effective bacterial meningitis treatments, used the epidemic as an opportunity to conduct biomedical research experiments on Nigerian children involving Pfizer’s “new, untested and unproven” antibiotic, trovaflozacin mesylate, better known by its brand name, Trovan®.”

Plaintiffs charge Pfizer with violating the Nuremberg Code, the Declaration of Helsinki, article 7 of the International Covenant on Civil and Political Rights, FDA regulations and other norms of international law.

“Plaintiffs claim that Pfizer failed to explain to the children’s parents that the proposed treatment was experimental, that they could refuse it, or that other organizations offered more conventional treatments at the same site free of charge. Id. at *2. In addition, plaintiffs assert that half of the children who participated in Pfizer’s treatment program were deliberately given inadequate doses of ceftriaxone–an FDA-approved drug shown to be effective in treating meningitis–so that Trovan would look more effective by comparison. Id. According to plaintiffs, five of the children who received Trovan and six of the children who were “low-dosed” with ceftriaxone died and others treated by Pfizer suffered very serious injuries, including paralysis, deafness and blindness. Id.”

At issue was whether Plaintiffs could obtain justice in a Nigerian Court–which they documented, they could not.

The case, Abdullahi v. Pfizer, Inc., No. 02-9223 (2d Cir. 10/08/2003) Nos. 02-9223 (L), 02-9303 (XAP) October 8, 2003 See: http://biotech.law.lsu.edu/cases/research/Abdullahi_v_Pfizer.htm

The case may signal to pharmaceutical companies that human beings even in countries ruled by corrupt oppressive regimes, are entitled to human rights protection afforded by international ethical research guidelines.

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