Pfizer Seeks Dismissal of Lawsuit in Nigeria
Wednesday, August 8, 2007
Pfizer has asked a Nigerian court to throw out a $2 billion lawsuit, saying that company researchers did no harm and in fact saved lives when they gave children an experimental drug during a 1996 meningitis epidemic.
In a 26-page brief filed in the northern Nigerian state of Kano, Pfizer described the clinical drug trial of an antibiotic known as Trovan as legal and ethical. The filing provides the New York company's most complete defense since Nigerian authorities levied 31 criminal charges and $8.5 billion in civil claims against Pfizer and its representatives.
Nigerian authorities filed four legal actions in May in state and federal courts. They allege that the Trovan trial led to the deaths of 11 children and injured 189 others. Nigerian prosecutors also say that the company did not tell families that their children were participating in a drug experiment. Pfizer's response addresses only allegations made in the civil case in Kano state court.
Pfizer's lawyers assert in the filing that "all clinical evidence points to the fact that any deaths were the direct result of the meningitis itself."
"The defendants always acted in the best interest of the children involved, using the best medical knowledge available," the filing says. "The defendants believed Trovan could save lives."
Pfizer said the survival rate was 94.4 percent for children given Trovan and 93.8 for a comparison drug. The survival rate for the rest of the hospital, where the aid organization Doctors Without Borders was treating victims of the epidemic, was about 90 percent, Pfizer said.
The company also argued that prosecutors should have brought their case within three years of learning of the drug trial in a December 2000 Washington Post series and a subsequent government investigation. Pfizer said the Kano state government had no standing to bring a civil lawsuit because the alleged harm affected families, not the government.
Pfizer said that local nurses told parents they could choose whether their children would be treated by Pfizer or by Doctors Without Borders, which was administering a proven antibiotic. The company said it explained the trial to parents and obtained their consent orally before it enrolled their children in the study.
Pfizer said its researchers cut the size of injections of the comparison drug to one-third the recommended dose to reduce the intense pain of injecting such a shot into children. The company said it gave the smaller dosage four times a day and that the amount given was adequate to fight meningitis.
Authorities have alleged that Pfizer's lead researcher concocted and backdated a document that purported to show that a Nigerian ethics committee had approved the trial. Pfizer responded in its filing that such approval was not required under Nigerian law. The company added that it "did not fraudulently procure" the document.
"The defendant's long-term goal was to bring a life-saving and innovative form of antibiotic that could be used effectively in a pediatric meningitis epidemic in a developing country," the filing said. "It was the defendant's hope that this new drug would significantly reduce the cost of care and improve the treatment and health of patients in epidemics that cyclically ravage sub-Saharan Africa, including Nigeria."
Trovan was never approved for marketing to children but was approved for adult use in the United States. It briefly became one of the best-selling antibiotics in the country but was soon associated with reports of liver damage and deaths.