Pfizer Seeks Dismissal of Lawsuit in Nigeria
Company Defends Tests on Children, Says Lives Saved in Epidemic

By Joe Stephens
Washington Post Staff Writer
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.

In 1999, the Food and Drug Administration severely restricted use of Trovan. The European Union banned its use altogether at about the same time.

The Post articles in 2000 touched off street demonstrations and expressions of outrage in Nigeria. The country's health minister appointed a commission to investigate. It quickly submitted a detailed report, but the findings were not released.

In May 2006, The Post obtained and published the Health Ministry's report, which concluded that Pfizer had violated Nigerian law, the international Declaration of Helsinki and the U.N. Convention on the Rights of the Child. The commission concluded that Pfizer did not obtain formal government approval to conduct the trial.

Previously confidential documents, recently obtained by The Post, show the May 2006 article set in motion the current lawsuit. Within days, the Nigerian government launched a criminal investigation. "The people in the federal Justice Ministry had no idea about this," said Babatunde Irukera, an attorney for the ministry. "People in government at that point said, 'Oh my God, we have to deal with this.' "

On June 19, 2006, Bayo Ojo, then Nigeria's attorney general, wrote to the Nigerian health minister to request a copy of the report. Two days later, a memo signed by Nigerian health officials advocated steps to "salvage the situation." Among them: "Take immediate legal action against Pfizer for deceiving and violating the fundamental human rights of Nigerians."

In October, Ojo arrived at the company's New York City headquarters and demanded a monetary settlement. A short time later, the company was contacted by attorneys from Chicago and St. Louis who identified themselves as working on behalf of the attorney general.

"The situation was bizarre," said Atiba D. Adams, a Pfizer attorney. "The private attorneys were not interested in Pfizer's perspective on what happened in 1996. There was absolutely no explanation and no information about what this 'compensation' was to be used for."

Adams said Pfizer tried to reach the attorney general for clarification. When that failed, Pfizer executives went to the top -- Pfizer's Nigerian representatives met privately with President Olusegun Obasanjo.

An infuriated Ojo thought Pfizer was making an end run. On Dec. 27, he complained to Pfizer that the meetings with the president raised "ethical questions" and directed the company to deal solely with him and his representatives. Pfizer executives wrote back that "any discussions between our country office and the president or any other government official about the Kano matter is not a break in protocol but consistent with Pfizer's obligation to remain a good corporate citizen."

Obasanjo and Ojo left office in May. The charges against Pfizer were filed in the final days of their tenure. Prosecutors said charges pending in federal and state court include forgery, fraud, possession of an illegal drug, unauthorized practice of medicine, criminal conspiracy and voluntarily causing grievous harm.

The charges do not include bribery, but Nigerian prosecutors said in a government memo obtained by The Post that Pfizer operatives bribed or attempted to bribe Nigerian officials on a number of occasions in 1996. Five years later, the memo states, Pfizer tried to bribe head of the commission that investigated the trial, Abdulsalami Nasidi. The memo did not specify who made the offer, the amount offered or the time the alleged event occurred.

Reached by telephone in Geneva, Ojo said: "They wanted the report to be in their favor; they wanted him to suppress the facts."

Adams said Pfizer was unaware of the bribery allegations until given a copy of the memo by The Post. In a written statement, Pfizer said: "These allegations have never been made in the litigation or at any time since the Trovan study was conducted 11 years ago, and we are aware of no evidence to support them."

Prosecutors said they withdrew their federal lawsuit July 20 and replaced it the same day with a more detailed complaint, but a Pfizer spokesman said the company has no evidence of the new lawsuit.