A lawsuit against Pfizer for allegedly testing a new drug without the patients’ consent may go forward, said the U.S. Court of Appeals for the Second Circuit. The divided ruling allows 88 Nigerian families to pursue their claim against the drug manufacturer under a 1789 law that gives foreigners the right to tort claims in federal courts for violations of the "law of nations."
The lawsuit claims Pfizer tested 200 Nigerian children who had contracted meningitis during a 1996 outbreak. Pfizer allegedly treated half with Ceftriaxone, an FDA-approved drug, and the other half with a new drug, Trovan. The families claim they were not informed of the nature of the experiment or the possible fatal side-effects of Trovan. They also assert that Pfizer used lower doses of Ceftriaxone in order to boost the apparent effectiveness of Trovan. The testing led to the death of 11 children and left many others blind, deaf, paralyzed or brain damaged, according to the families.
In a statement issued the day of the court’s ruling, Pfizer said it had the consent of the parents of children involved in the study, and that the study "was consistent with both international and Nigerian laws." In addition, it states that the deaths and injuries were "the direct result of the illness, and not the treatment provided to patients" in the study.
The 1789 law, also known as the Alien Tort Statute, has previously been narrowly interpreted. In upholding the lawsuit, the majority cited to the Nuremberg Code, which states that "voluntary consent of the human subject is absolutely essential" in medical experiments. The dissent, however, believed the agreements cited by the majority did not establish a private right of action against non-state actors.
If the allegations in this lawsuit are true, this behavior by a drug manufacturer is reprehensible. One wonders, if true, why Pfizer chose presumably poor African children for such "treatment". Was it because it expected no negative repercussions because these children, and their families, were too poor to protest? I hope not, but I certainly question these activities.