C.A.:Pfizer

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“ during an epidemic of bacterial meningitis in northern Nigeria.FN1 The appellants allege that at that time, Pfizer, the world’s largest pharmaceutical corporation, sought to gain the approval of the U.S. Food and Drug Administration (“FDA”) for the use on children of its new antibiotic, Trovafloxacin Mesylate, marketed as “Trovan.” They contend that in April 1996, Pfizer, dispatched three of its American physicians to work with four Nigerian doctors to experiment with Trovan on children who were patients in Nigeria’s Infectious Disease Hospital (“IDH”) in Kano, Nigeria.

Working in concert with Nigerian government officials, the team allegedly recruited two hundred sick children who sought treatment at the IDH and gave half of the children Trovan and the other half Ceftriaxone, an FDA-approved antibiotic the safety and efficacy of which was well-established. Appellants contend that Pfizer knew that Trovan had never previously been tested on children in the form being used and that animal tests showed that Trovan had life-threatening side effects, including joint disease, abnormal cartilage growth, liver damage, and a degenerative bone condition.

Pfizer purportedly gave the children who were in the Ceftriaxone control group a deliberately low dose in order to misrepresent the effectiveness of Trovan in relation to Ceftriaxone. After approximately two weeks, Pfizer allegedly concluded the experiment and left without administering follow-up care. According to the appellants, the tests caused the deaths of eleven children, five of whom had taken Trovan and six of whom had taken the lowered dose of Ceftriaxone, and left many others blind, deaf, paralyzed, or brain-damaged.

*2 Appellants 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 appellants 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 Médecins Sans Frontières (Doctors Without Borders) was providing a conventional and effective treatment for bacterial meningitis, free of charge, at the same site.FN2

The appellants allege that, in an effort to rapidly secure FDA approval, Pfizer hastily assembled its test protocol at its research headquarters in Groton, Connecticut, .  .   .  “ (IBID).

The appellate judges decided that the lower court was in error in dismissing the case.  They further found that: “ The judgment (at Nuremberg) (emphasis mine) concluded that “[m]anifestly human experiments under such conditions are contrary to the principles of the law of nations as they result from usages established among civilized peoples, from the laws of humanity, and from the dictates of public conscience.” Id.
(emphasis added and internal quotation marks omitted).

The Code created as part of the tribunal’s judgment therefore emphasized as its first principle that “[t]he voluntary consent of the human subject is absolutely essential.” Id. at 181.

The American tribunal’s conclusion that action that contravened the Code’s first principle constituted a crime against humanity is a lucid indication of the international legal significance of the prohibition on nonconsensual medical experimentation. As Justices of the Supreme Court have recognized, “[t]he medical trials at Nuremberg in 1947 deeply impressed upon the world that experimentation with unknowing human subjects is morally and legally unacceptable.” (IBID).

The judges also cited the “bedrock norms” referred to in the Stanley decision.

From the case:

“United States v. Stanley, 483 U.S. 669, 687, 107 S.Ct. 3054, 97 L.Ed.2d 550 (1987) (Brennan, J., concurring in part and dissenting in part) (emphasis added); see also id. at 709-10 (O’Connor, J., concurring in part and dissenting in part).

Moreover, both the legal principles articulated in the trials’ authorizing documents and their application in judgments at Nuremberg occupy a position of special importance in the development of bedrock norms of international law.

United States courts examining the Nuremberg judgments have recognized that “[t]he universal and fundamental rights of human beings identified by Nuremberg-rights against genocide, enslavement, and other inhumane acts …-are the direct ancestors of the universal and fundamental norms recognized as jus cogens, from which no derogation is permitted, irrespective of the consent or practice of a given State.
Siderman de Blake v. Republic of Arg., 965 F.2d 699, 715 (9th Cir.1992) (cited in Sampson v. F.R.G., 250 F.3d 1145, 1150 (7th Cir.2001)).”  (IBID).

This court found that adherence to the Nuremberg Code’s prohibition on non-consensual experimentation was an accepted mode of practice in the United States. It is an issue of law to be decided at trial in this case.