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Unfortunately I believe that we are limited in what we can focus on. I think that if we proceed with the partisan sideshow of prosecuting Bush admin. officials, healthcare will get lost in the brouhaha.
— Posted by denamom, Obama's Quandary...

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Court Revives Lawsuits Against Pfizer by Nigerian Families

POSTED: 05:07 PM ET, 01/30/2009 by The Editors

Updated at 4:57 p.m. Jan. 30

By Joe Stephens
Washington Post staff writer

A federal appeals court on Friday revived two lawsuits brought against Pfizer by Nigerian families who claim the giant drugmaker used their children in an illegal test of an experimental antibiotic.

The 2nd U.S. Circuit Court of Appeals in New York ruled that the suits, dismissed earlier by a lower court judge who said they should have been brought in Nigeria, can now go forward in the U.S. courts. Lawyers said the ruling could set a precedent affecting other American companies accused of wrongdoing overseas.

The lawsuits seek unspecified damages on behalf of the families, who claim Pfizer violated international law by testing the drug, known as Trovan, on gravely ill children without their knowledge. Eleven children died during the 1996 clinical trial, carried out during a record meningitis epidemic. Other children developed brain damage and crippling arthritis.

"This is a homerun for us," said Richard P. Altschuler, an attorney for the families. "The judges are making a statement. They are telling companies, if you go overseas, justice will come back to the United States."

Pfizer also is the target of criminal and civil legal actions in Nigeria, where authorities are seeking damages of more than $8 billion. While the ruling in New York has no direct effect on the Nigerian actions, attorneys in the case said it could complicate long-running settlement negotiations there.

Pfizer issued a statement dismissing the court action as "only a procedural ruling."

"It is not a determination on their merits," the statement said. "Indeed, the strong dissent by one of the judges may be grounds for further appellate proceedings. Pfizer remains confident that it will prevail in these cases, and is weighing its options on how to best respond to this decision."

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

The experiment came to light in December 2000, when The Washington Post published a lengthy examination of the trial. It found Pfizer carried out the experiment on 200 children at a makeshift epidemic camp in the northern Nigerian town of Kano. The articles reported that Pfizer had no signed consent forms for the children and relied on a falsified ethics approval letter to defend the design of the experiment.

Trovan was never approved for use by American children. The Food and Drug Administration approved it for adults in 1998 but later severely restricted its use after reports of liver failure. The European Union banned the drug in 1999.

In the majority opinion in the 2-to-1 ruling, Circuit Judge Barrington D. Parker wrote that "the administration of drug trials without informed consent on the scale alleged in the complaints poses a real threat to international peace and security."

Such unethical experimentation, Parker wrote, "fosters distrust and resistance to international drug trials, cutting-edge medical innovation, and critical international public health initiatives in which pharmaceutical companies play a key role. ... As this case illustrates, the failure to secure consent for human experimentation has the potential to generate substantial anti-American animus and hostility."

Babatunde Irukera, a lawyer representing the Nigerian government, said settlement negotiations in Nigeria have been productive. But discussions there have centered on Pfizer paying a sum to settle all outstanding claims, including those of the families. Now, the families may decide to pursue a separate remedy in the United States, setting back the talks in Nigeria, he said.

Pfizer's attorneys have already offered more than $50 million to settle the Nigerian cases, Irukera said, but authorities there rejected the figure.

Chris Loder, a Pfizer spokesman in New York, declined to discuss specific figures but confirmed the negotiations.

"We continue to be interested in an amicable settlement that would help improve and expand healthcare for the people of Nigeria," Loder said. "The settlement process is ongoing and we are prepared to stay at the negotiating table until we reach such an agreement."

In its statement, Pfizer said that the company "has great sympathy for everyone who suffered during the devastating meningitis epidemic in 1996. The company has said all along that all clinical evidence points to the fact that any deaths or injuries were the direct result of the illness, and not the treatment provided to patients in the Pfizer study. With a survival rate of 94.4 percent, Trovan helped save lives and was at least as effective as the best treatment available at Kano's Infectious Disease Hospital."

By The Editors |  January 30, 2009; 5:07 PM ET Post Investigations
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