The Supreme Court said on Tuesday that it rejected an appeal by Pfizer on a ruling that reinstated U.S. lawsuits by Nigerian families, who say the drugmaker tested an experimental antibiotic on their children without getting adequate consent. The justices declined to review a ruling by a U.S. appeals court in New York that allowed the lawsuits involving alleged harm caused by the drug Trovan to go forward.
Pfizer conducted clinical trials of the drug in Nigeria during a 1996 meningitis epidemic. Families of some of the children who participated said the tests caused deaths and various injuries. According to the lawsuits, Pfizer violated international law by failing to obtain adequate consent from the patients. The lawsuits sought unspecified damages on behalf of the children who were part of the study.
The drugmaker said the clinical study was conducted with the approval of the Nigerian government and it had the consent of participants' parents or guardians. Pfizer said the trial violated no international or Nigerian laws. Pfizer said the appellate ruling expanded the jurisdiction of the Alien Tort Statute, a more than 200-year-old law, to American corporations doing business abroad, raising issues of "national and international importance."
A federal judge initially dismissed the lawsuits, ruling the cases should be heard in Nigeria, not the U.S. In 1998, the U.S. Food and Drug Administration approved Trovan for use by adults only. After reports of liver failure, its use was restricted in this country to adult emergency care. The EU banned its use in 1999. The Obama administration urged the justices to reject Pfizer's appeal, saying the questions presented did not warrant Supreme Court review.
The court agreed and rejected the pharmaceutical company's appeal without any comment.
