London, June 6:

The Nigerian government is suing the world’s largest drug manufacturer, Pfizer, for GBP3.5 billion in damages for allegedly carrying out illegal trials of an anti-meningitis drug that killed and disabled children.

The children died or suffered serious side effects when the antibiotic Trovan was administered in Kano during a meningitis outbreak in 1996. The government of Kano, a northern state in Nigeria, also has civil and criminal cases pending against Pfizer.

The Nigerian authorities say 200 children were involved in the Trovan experiment, without the approval of local regulatory authorities. They allege that as many as 11 died because of the treatment and that others developed deformities, including brain damage and paralysis.

Trovan was approved in the US in 1997 for use by adults but not by children. Two years later the US Food and Drug Administration warned that the drug could cause liver damage. The medicine has since been discontinued.

In court papers, filed in the Nigerian capital, Abuja, on Monday, the government accused Pfizer of conducting illegal tests on children.

“The plaintiff contends that the defendant never obtained approval of the relevant regulatory agencies nor did the defendant seek or receive approval to conduct any clinical trial at any time before their illegal conduct,” a statement says.

Bryant Haskins, a Pfizer spokesman in New York, said the drug was administered in accordance with Nigerian law. “These allegations against Pfizer, which are not new, are highly inflammatory and not based on all the facts,” he said.

“We continue to maintain that the Nigerian government was fully informed in advance of the clinical trial; that the trial was conducted appropriately, ethically and with the best interests of patients in mind; and that it helped save lives.”

Pfizer has said previously that it obtained “verbal consent” from the parents of the affected children, and that the drugs were administered properly. But, before the trial, Juan Walterspiel, a disease specialist for Pfizer, warned the company that the drug was not “tested for its sensitivity before the first child was exposed to a live-or-die experiment”. Human rights groups have already accused some drugs firms of using Africa as a testing ground for medicines not approved by Europe or the US.

In response to the Nigerian case, a US congressman, Tom Lantos, introduced laws to ensure safer testing of drugs in foreign countries. But the legislation ended last year.