In a case that could create new liabilities for U.S. research conducted abroad, 30 Nigerian families have sued pharmaceutical giant Pfizer Inc., alleging that the company unethically tested an antibiotic on their children during a 1996 meningitis outbreak. The unusual suit--filed by foreign citizens in a U.S. court under a 210-year-old U.S. law originally designed to combat pirates--seeks to recover unspecified damages from the company for death and serious disabilities.
The lawsuit is the latest development in a 5-year-old controversy. In 1996, an outbreak of bacterial meningitis in Nigeria claimed an estimated 15,000 lives. In the midst of it, Pfizer obtained permission from the Nigerian government and the U.S. Food and Drug Administration (FDA) to test the then-experimental oral form of Trovan (the trade name for trovafloxacin). Medical teams from Pfizer and Johns Hopkins in Baltimore, composed of both U.S. and Nigerian doctors, gave the drug to about 100 children selected from long lines of patients awaiting help. An equal number of control patients received a proven drug.
The complaint, filed on 29 August in a federal district court in New York City, alleges that Pfizer researchers violated international law by failing to obtain informed consent from the families. The families allege that Pfizer increased the risk of death and injury by failing to provide the proven treatment to patients who did not improve after swallowing Trovan and by giving control patients a weakened version of the standard therapy. Eleven of the enrolled children--including both treated and control patients--died, and others became paralyzed or deaf, according to the complaint.
A New York City law firm last week took the Nigerians' case to Pfizer's home turf using a novel legal strategy. Lawyers at Milberg Weiss Bershad Hynes & Lerach argue that Pfizer is vulnerable under the 1789 Alien Tort Claims Act, which allows foreign nationals to use U.S. courts to sue individuals and companies that have broken international laws on foreign soil. In this case, the Nigerian families charge that Pfizer has violated ethical research rules, including the Nuremberg Code of 1947.
Pfizer rejects the charges, saying in a 30 August statement that it is "proud of the way the study was conducted," the study was "well conceived and well executed," and it "saved lives." The company says it obtained prior consent from both the Nigerian government and patients' families.