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US High Court Asks Administration To Comment On Nigeria Drug Trial Case

By Brent Kendall, Of DOW JONES NEWSWIRES

WASHINGTON -(Dow Jones)- The U.S. Supreme Court on Monday asked the Obama administration's solicitor general to weigh in on Pfizer Inc.'s (PFE) challenge to a pair of lawsuits alleging the drug maker illegally tested an antibiotic drug on children in Nigeria in 1996.

Two groups of Nigerian families alleged that Pfizer violated international law when it tested the experimental drug Trovan on 200 Nigerian children during an outbreak of bacterial meningitis.

The plaintiffs alleged that Pfizer conducted the clinical trial without proper consent from the children's guardians and didn't disclose the experimental nature of the study or the serious risks involved.

The clinical trial caused the deaths of 11 children and left others blind, deaf, paralyzed or brain-damaged, the plaintiffs alleged.

Pfizer said the study, conducted in the Nigerian state of Kano, took place with the approval of the Nigerian government and the consent of the children's parents. The drug maker said any deaths were the result of the illness, not of the clinical trial.

A federal trial judge in New York threw out the lawsuits in 2005, ruling that international law didn't provide a basis for the plaintiffs to sue Pfizer in U.S. courts for the alleged clinical-trial violations.

However, a divided Second U.S. Circuit Court of Appeals revived the lawsuits in January, deciding the plaintiffs could proceed with the case.

"The norm prohibiting nonconsensual medical experimentation on human subjects has become firmly embedded and has secured universal acceptance in the community of nations," the Second Circuit majority said in its ruling.

Pfizer, in its petition to the Supreme Court, argued that the lower-court ruling dramatically expanded legal liability for U.S. corporations doing business abroad. The U.S. Chamber of Commerce supported Pfizer's position.

The drug maker is also facing legal action in Nigeria. In 2007, Nigeria's government filed a $7 billion lawsuit against Pfizer and several employees. In July, the drug maker agreed to pay up to $75 million to settle a separate lawsuit filed by the state of Kano.

In 1998, the U.S. Food and Drug Administration approved Trovan for adult use only, and the drug has since been restricted for use only in emergency care. The drug was banned in the European Union.

The case is Pfizer v. Abdullahi, 09-34.

-By Brent Kendall, Dow Jones Newswires; 202-862-9222; brent.kendall@ dowjones.com

(Kristina Peterson contributed to this article.)

  (END) Dow Jones Newswires
  11-02-091032ET
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