W. Haven lawyer hopeful in Pfizer suit

After seven years spent pursuing a $2 billion lawsuit against Pfizer Inc. on behalf of Nigerian children who died because of the alleged effects of an experimental drug, a West Haven lawyer believes a legal settlement in a related case between Pfizer and the Nigerian government is finally imminent.

"This case has been incredible in its twists and turns, its ups and downs," said attorney Richard Altschuler, who has been working with his Nigerian co-counsel, Etigwe Uwa.

The two lawyers were heartened by a recent article in Forbes magazine reporting Pfizer is said to have offered to settle the case with the Nigerian government for $150 million. The government has sought $8.5 billion in restitution and damages and prison terms for Pfizer officials.

But when asked for comment on the Forbes report, Pfizer spokesman Christopher Loder said the $150 million figure is not accurate.

"It's not appropriate to comment on this at this time," Loder said. He acknowledged Pfizer representatives are discussing the case with Nigerian officials and he said "an amicable resolution is in the best interests of all parties."

Pfizer officials have maintained throughout the dispute that the 1996 clinical trial helped save lives and was conducted properly. They also said the deaths resulted from diseases the children had already contracted before being given any Pfizer drugs.

Altschuler sued Pfizer in federal district court in Connecticut in 2002 because he believed Pfizer officials "hatched this diabolical scheme" at the corporation's development offices in Groton and New London. Pfizer has a satellite office in New Haven.

In 2005, a federal judge in New York ruled the lawsuit should be heard in Nigeria, not America. Altschuler appealed to the 2nd U.S. Circuit Court of Appeals and he is awaiting its decision.

The "scheme," Altschuler alleged, was to use the drug Trovan, an antibiotic that had shown potential against infections, on hospitalized Nigerian children in order to eventually make a large profit selling the drug worldwide.

But the drug reportedly had demonstrated serious side effects, including liver problems, in tests on young rats and dogs.

According to a Nigerian Federal Ministry of Health report, Pfizer doctors went to a hospital in Kano, Nigeria, in 1996 during an epidemic of meningitis and administered Trovan to 98 critically ill children and a comparison drug, ceftriaxone, to 100 other very sick children.

Uwa said 11 of the children died soon afterward. He said five of them had been given Trovan and the other six received ceftriaxone.

But in his lawsuit, Altschuler alleged that up to 34 children died during the clinical trial and 20 were severely disabled.

Altschuler represents 58 of the Nigerians and has merged his case with a New York law firm representing 53 others.

"Two-thirds of them died, and one-third became deaf, dumb and blind," Altschuler charged.

Altschuler's lawsuit includes a long list of allegations against Pfizer's methods by one of its former researchers, Dr. Juan Walterspiel. He was also a pediatric infectious disease specialist at Yale School of Medicine.

Walterspiel, who did not go to Nigeria to help with the drug trial, later wrote to Pfizer's chief executive at the time, William Steere, warning the Nigerian study was "in violation of ethical rules for the conduct of medical experiments in humans."

According to Altschuler's lawsuit, Walterspiel also told Pfizer officials before, during and after the tests that Pfizer's methods "could result in life-threatening illnesses and deaths to the children enrolled."

Walterspiel also alleged Pfizer representatives failed to obtain proper informed consent by the children's parents and did not provide adequate follow-up care.

According to Forbes, Pfizer fired Walterspiel the day after he wrote his letter, prompting him to file a wrongful termination lawsuit in Connecticut federal court, which eventually was settled.

Walterspiel, now a consultant in the San Francisco area, could not be reached for comment.

Loder declined to discuss Walterspiel. Loder said Pfizer officials did obtain oral consent from the patients' parents. Altschuler said international law requires written consent.

Loder said Pfizer obtained approval for the study from Nigerian federal and state agencies.

According to Loder, children who contracted meningitis and were treated with Trovan by Pfizer had a survival rate of 94.4 percent. He said the overall survival rate for Nigerians with meningitis was less than 90 percent.

Trovan performed at least as well as the other meningitis drugs used at that Kano hospital, Loder said.

He said clinical evidence shows all 11 of the children's deaths "were the direct result of the devastating disease and not the treatments provided."

But Forbes noted that in 1999 the Food and Drug Administration raised concerns about Trovan's effect on livers in other patients. Loder said Pfizer officials agreed to severely restrict its use.

Asked if the formerly "promising" Trovan is still is use, Loder said Pfizer stopped manufacturing it in 2003 "due to lack of demand."

Randall Beach can be reached at rbeach@nhregister.com or 789-5766.