UPDATE 2-US top court rejects Pfizer Nigeria lawsuit appeal

Tue Jun 29, 2010 12:50pm EDT

* Lawsuit said Pfizer failed to obtain adequate consent

* Company says it got consent, that Nigerian govt approved

* Pfizer says it is confident it will ultimately prevail (Adds Pfizer reaction penultimate three paragraphs, case name last paragraph, byline)

By James Vicini

WASHINGTON, June 29 (Reuters) - The Supreme Court declined to hear an appeal by Pfizer Inc (PFE.N) of a ruling that reinstated U.S. lawsuits by Nigerian families who said the drugmaker tested an experimental antibiotic on their children without getting adequate consent.

The justices, without comment, let stand a ruling by a U.S. appeals court in New York that allowed the lawsuits involving alleged harm caused by the drug, Trovan, to go forward.

Pfizer conducted clinical trials of the drug in Nigeria during a 1996 meningitis epidemic. Families of some of the children who participated said the tests caused deaths and various injuries.

According to the lawsuits, Pfizer violated international law by failing to obtain adequate consent from the patients. The lawsuits sought unspecified damages on behalf of the children who were part of the study.

The drugmaker said the clinical study was conducted with the approval of the Nigerian government and that it had the consent of participants' parents or guardians. Pfizer said the trial violated no international or Nigerian laws.

Pfizer said the appellate ruling expanded the jurisdiction of the Alien Tort Statute, a more than 200-year-old law, to American corporations doing business abroad, raising issues of national and international importance.

A federal judge initially dismissed the lawsuits, ruling the cases should be heard in Nigeria, not the United States.

In 1998, the U.S. Food and Drug Administration approved Trovan for use by adults only. After reports of liver failure, its use in the United States was restricted to adult emergency care. The European Union banned its use in 1999.

The Obama administration urged the justices to reject Pfizer's appeal, saying the questions presented did not warrant Supreme Court review.

Pfizer said in a statement, "Today's decision, however, is not a determination on the merits of these cases, but rather a procedural ruling."

It said the cases will go back to a federal judge in New York, where the company can again move to dismiss them on various grounds, including that Nigeria would be the appropriate place for the cases to be heard.

"The company looks forward to presenting its defenses in court and remains confident it will ultimately prevail in these cases," Pfizer said.

The Supreme Court case is Pfizer Inc v. Abdullahi, No. 09-34. (Reporting by James Vicini; Editing by Gerald E. McCormick, Dave Zimmerman and Steve Orlofsky)

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