1789 Law and Nuremburg Code Intersect to Permit Claims To Proceed Against Pfizer For Conducting Medical Experimentation Without Consent

The Alien Tort Statute, 28 U.S.C. 1350, a 1789 law, gives foreigners the right to raise tort claims in federal court to vindicate violations of ‘the laws of nations.’ The 10-principle Nuremberg Code was formulated as part of a war crimes trial conducted after World War II in which 15 doctors were convicted of crimes against humanity for conducting non-consentual experiments. Seven of the doctors were sentenced to death.

The 1789 law and the 20th Century Nuremberg Code intertwined recently as the U.S. Court of Appeals for the Second Circuit revived Nigerian families’ damage claims for billions of dollars against Pfizer for allegedly secretly testing a new drug in a Nigerian hospital during a 1996 meningitis outbreak.

The two cases under the consolidated caption of Abdullahi v. Pfizer, 05-4863 and 05-6768 involved claims that Pfizer allegedly secretly testing a new drug in a Nigerian hospital during a 1996 meningitis outbreak. In early 1996, within weeks of learning about the meningitis epidemic from an Internet site, Pfizer, the world’s largest pharmaceutical company, sent a six-member research team to the Infectious Disease Hospital in Kano, Nigeria, a city suffering concurrent epidemics of bacterial meningitis, measles and cholera. The Pfizer team selected children for its test from the long lines of ailing people seeking care at the hospital. The meningitis epidemic killed more than 15,000 Africans.

Pfizer treated 100 Nigerian children with the antibiotic Trovan as part of its effort to determine whether the drug, which had never been tested in children, would be an effective treatment for the disease. Pfizer treated 100 other children with ceftriaxone, the gold standard for meningitis treatment, but, the suit says, at a lower-than-recommended dose. Eleven children in the trial died, and others suffered brain damage, were partly paralyzed or became deaf.

Trovan went on the market in 1998 and quickly became one of the most prescribed antibiotics in the United States, selling more than $160 million the first year. But there were soon reports of liver damage, and the F.D.A. recommended in 1999 that Trovan be used only for severely ill patients in institutional settings. Use on children has not been approved.

Litigation began in 2001 in the first suit in the United States seeking damages from an American pharmaceutical company for what the plaintiffs contend was medical experimentation on foreign citizens without their consent. The plaintiffs claim that Pfizer, working in partnership with the Nigerian government, failed to secure the informed consent of either the children or their guardians and specifically failed to disclose or explain the experimental nature of the study or the serious risks involved. Although the treatment protocol required the researchers to offer or read the subjects documents requesting and facilitating their informed consent, this was allegedly not done in either English or the subjects’ native language of Hausa.

The plaintiffs also contend that Pfizer deviated from its treatment protocol by not alerting the children or their guardians to the side effects of Trovan or other risks of the experiment, not providing them with the option of choosing alternative treatment, and not informing them that the non-governmental organization MZdecins Sans Frontires (Doctors Without Borders) was providing a conventional and effective treatment for bacterial meningitis, free of charge, at the same site. The issue before the court regarding the Alien Tort Statute was whether the conduct of Pfizer rose to a level sufficient to invoke the law’s protection. Over a vigorous dissent, the court held that it did.

Both the majority and dissent cited the leading U.S. Supreme Court case construing the act, Sosa v. Alvarez-Machain, 542 U.S. 692 (2004), requires ‘vigilant gatekeeping.’ But the majority concluded that claims of unconsented medical experimentation are cognizable under the act. The first principle of the Nuremberg Code states that in medical experiments, ‘the voluntary consent of the human subject is absolutely essential.’

Judge Barrington D. Parker wrote for the majority, ‘History illustrates that from its origins with the trial of Nazi doctors at Nuremberg through its evolution in international conventions, agreements, declarations and domestic laws, the norm prohibiting nonconsensual medical experimentation on human subjects has become firmly embedded and secured universal acceptance in the community of nations,’.

Judge Rosemary Pooler joined the majority. Judge Richard C. Wesley contended the Nuremberg trials and the international agreements cited by the majority did not establish a private right of action against non-state actors, writing that they were not war crimes performed on prisoners of war and were not ‘rare acts by private individuals’ that the world has ‘collectively’ determined are ‘so serious as to threaten the very fabric of international affairs.’ In a statement, Pfizer said its 1996 clinical study was conducted with the consent of the children’s parents and ‘was consistent with both international and Nigerian laws.’

Any deaths or injuries were ‘the direct result of the illness, and not the treatment provided to patients in the Pfizer study,’ the company stated. Pfizer has said its doctors obtained oral consent from patients’ parents. A plaintiffs’ lawyer, however, says that international law requires written consent. The case may end up being heard in Nigeria because the Second Circuit, upon the agreement of the parties, did not review that portion of Southern District Judge William H. Pauley’s ruling dismissing the case on the ground of forum non conveniens. In 2007 the state of Kano in Nigeria filed criminal and civil charges against Pfizer, seeking more than $2 billion in damages and restitution. The federal government of Nigeria also sued Pfizer and several of its employees, seeking $7 billion in damages.

Leave a Reply

Your email address will not be published. Required fields are marked *