Sunday, June 17, 2007

West Haven attorney wants lawsuit involving Nigeria, Pfizer tried in U.S.

hen the government of Nigeria filed a $7 billion lawsuit against Pfizer Inc. earlier this month, West Haven lawyer Richard Altschuler was so elated he picked up the phone and called his co-counsel in Nigeria — forgetting it was 3 a.m. in that West African nation.

"This is a total shock to us that the new government is bringing an action," said Altschuler, who sued both Pfizer and a previous Nigerian government in 2002 on behalf of the parents or guardians of 58 Nigerian children who in 1996 received an experimental drug made at Pfizer’s research facility in Groton.
Altschuler’s suit claims many of the children died or suffered severe injuries as a result of taking the drug Trovan. Pfizer officials say the children who received Trovan had better outcomes than those who did not.

The government lawsuit makes many of the same allegations that Altschuler has made.

"When I heard the news, it was overwhelming," said Altschuler. "I felt vindicated."

But while the massive government lawsuit, which includes the threat of criminal charges, could help Altschuler’s $2 billion civil lawsuit against the pharmaceutical giant, it could also hurt, he acknowledged.

"It helps my case, because the government is saying, ‘What you’re saying here is true,’" Altschuler said. "That’s a big wind behind my sails."

However, the Nigerian action could hurt Altschuler’s efforts to have his case tried in the United States rather than in Nigeria, since it indicates the government may now be interested in seeing that a trial takes place, he said. An earlier lawsuit filed by Altschuler in Nigeria never came to trial.

"It’s confusing as to what the government’s motive is," said Altschuler, who noted the government has changed twice since 1996. "It’s a little late in coming. And it’s really too good to be true."

Altschuler is scheduled to argue July 12 before the U.S. Court of Appeals for the 2nd Circuit in New York, in an attempt to have his lawsuit tried in the United States.

Trovan was administered to children who fell victim to a meningitis epidemic in Kano State in northern Nigeria in the spring of 1996. Kano State officials filed a separate, $2 billion lawsuit against Pfizer last month.

Pfizer officials traveled to Nigeria and treated 100 meningitis-infected children with the experimental antibiotic Trovan, while treating another 100 sick children — as control patients — with an approved drug, ceftriaxone. (Altschuler says 300 children were involved, but the Nigerian government and Pfizer say 200 children were involved.)

Altschuler claims Pfizer intentionally gave the control group low doses in order to make Trovan look better. Pfizer officials have denied that, saying the doses were appropriate to the weakened condition of the children.

Altschuler’s suit claims that Pfizer knew Trovan could cause liver damage and joint problems in children and failed to disclose those risks, that Pfizer failed to obtain informed consent from the parents or guardians, and did not obtain permission from the Nigerian government to carry out the tests. The children all were under age 18.

Altschuler claims Pfizer wanted to quickly carry out human trials of Trovan in order to hasten its approval by the federal Food & Drug Administration. Since that time, the FDA has restricted the use of Trovan to people in hospitals or nursing homes with life- or limb-threatening infections.

Bryant Haskins, a spokesman for Pfizer in the company’s New York City headquarters, said the allegations against Pfizer are not true.

"We believe that we conducted the clinical studies in Nigeria in a very ethical and upfront manner," he said. "Most importantly we believe the clinical study saved lives. We strongly disagree with many of these allegations."

Altschuler’s lawsuit, for instance, claims the company quickly administered the drug and returned to the United States after a short period, with no follow-up medical care.

But Haskins disputes that. "We were there for the duration of the study and we did a six-week follow-up after that," Haskins said. "We went back and met with any and all of the children and families involved in the clinical study. We did exams of all the patients we were able to examine and our doctors did not find any unusual side effects. No patients were found to have relapsed from the treatment."

Haskins also said Pfizer obtained "oral consent from the parents or guardians" after explaining the study to them.

Altschuler claims up to 34 of the children died after taking Trovan, and about 20 others suffered brain damage, loss of hearing or sight, loss of motor skills and amputation of limbs.

Pfizer officials, however, say the death and disability rate among Trovan patients was significantly lower than for patients taking other treatments, and that none of the deaths were linked to Trovan. Haskins said the children were given excellent care.

"During the clinical study, if we found that any patient required care beyond what was available there at the camp, we transferred them to the best medical facility available in Nigeria at our expense, and that was a teaching hospital nearby," he said. "Three patients were transferred to the hospital during the study."

In May 2006, the Washington Post revealed the results of a confidential report written in 2001 by the Nigerian Federal Ministry of Health that concluded Pfizer had violated international law by conducting "an illegal trial of an unregistered drug" without permission from the Nigerian government.

The Nigerian government has indicated it plans to pursue criminal charges as well as the civil suit, but Haskins said Pfizer has not been served with any criminal papers at this point.

In the July 12 hearing, Altschuler will appeal a federal judge’s 2005 ruling that his case should be tried in Nigeria. Altschuler argues that the Nigerian court system is too corrupt. He originally filed the lawsuit in Nigeria in 2001 and was unable to get a judge to hear it. There are no juries in the Nigerian court system.

"The first judge was removed due to corruption, and the second judge delayed the case for seven months, then turned it down," Altschuler said. "Then we were told there were no more judges available."

He also said the case should be tried here because Pfizer developed the drug and planned the Nigerian trials in Connecticut and New York.

Haskins disagreed. "The position that the court has taken and that we have agreed with is that you’re talking about Nigerian citizens living in Nigeria," Haskins said. "Any claims of personal injury should be heard in Nigeria."

Connecticut Attorney General Richard Blumenthal said his office has been monitoring the case for years. "We haven’t taken a position on whether there is jurisdiction in Connecticut. We’re continuing to monitor and review," he said.

The new lawsuit filed by the Nigerian government claims the nation has spent $500 million treating and compensating the families of children involved in the Trovan test.

Altschuler said he has seen no evidence the government has provided that magnitude of support to those affected by the trial. "I’m not sure why they have decided to bring suit," he said. "I think it may be political burlesque."

Altschuler’s Nigerian co-counsel, Etigwe Uwa, said the government’s actions have been "inconsistent."

"When a similar suit was filed earlier in Kano, the government sought to dismiss it on technical grounds," said Uwa, a barrister and solicitor in Nigeria.

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