American Journal of Law & Medicine

International health law violations under the Alien Tort Statute: Federal Appeals Court reinstated lawsuit under the Alien Tort Statute against United States pharmaceutical company Pfizer brought by Nigerian children and their guardians - Abdullahi v. Pfizer, Inc.

International Health Law Violations Under the Alien Tort Statute: Federal Appeals Court Reinstated Lawsuit Under the Alien Tort Statute Against United States Pharmaceutical Company Pfizer Brought by Nigerian Children and Their Guardians--Abdullahi v. Pfizer, Inc. (1)--The United States Court of Appeals for the Second Circuit held that the district court had jurisdiction under the Alien Tort Statute (2) CATS") for a violation of the norm of customary international law prohibiting nonconsensual medical experimentation on human subjects. (3)

The plaintiffs alleged that three doctors from defendant's company, Pfizer, and four Nigerian doctors conducted a clinical drug trial with two hundred sick Nigerian children without their consent during a bacterial meningitis outbreak in Kano, Nigeria in 1996. The United States Food and Drug Administration ("FDA") had not approved the drug, Trovafloxacin Mesylate ("Trovan"). Pfizer received a March 20, 1996 letter from the Nigerian government and a March 28, 1996 letter from the ethics committee at Nigeria's Infectious Disease Hospital ("IDH") in Kano approving Pfizer's use of Trovan. Plaintiffs alleged, however, that no IDH ethics committee existed as of March 28, 1996. Working with Nigerian government officials at IDH, the doctors administered Trovan to half of the sick children and Ceftriaxone, an FDA approved antibiotic, to the other half at a lower dosage. As a result of the clinical trial ("Trovan Trial"), several children died while others became paralyzed, brain-damaged, deaf, and blind.

Plaintiffs claim that the defendant failed to obtain their informed consent to conduct the experimental treatment of Trovan and failed to disclose the experimental nature of the clinical trial and the risks and side effects of the treatment. …

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