The Nigerian government has launched a $7bn (£3.5bn) lawsuit against the world's largest drug manufacturer over claims that a medical experiment left children dead or with permanent disabilities.
Government lawyers filed the papers in the Nigerian capital, Abuja, claiming that drug tests carried out by Pfizer on children with meningitis resulted in nearly a dozen dying, and left others with brain damage, paralysis, and slurred speech. New York-based Pfizer has denied any wrongdoing.
It is the latest case against the multinational pharmaceutical firm relating to the 1996 drug study in the northern state of Kano during a meningitis epidemic in the state's main city, also called Kano.
A $2bn legal action is continuing by the Kano state government, which claims Pfizer illegally treated 100 children infected by meningitis with an experimental antibiotic, Trovan. Another 100 children, who were control patients in the study, received an approved antibiotic, ceftriaxone - but the dose was lower than recommended, the families' lawyers allege.
The latest case is the first time the national government has brought legal action. Papers filed yesterday at a federal high court allege that Pfizer did not obtain approval from the relevant regulatory agencies and acted unethically when it tested the antibiotic.
"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," according to court documents obtained by Reuters news agency.
Health authorities are demanding $5bn in general damages, $500m for treatment, compensation and support for the victims, $450m for damages related to money spent to overcome subsequent public suspicion of health policy and $1bn to pay for health programmes.
After taking preliminary arguments from counsels to both parties, Justice Babs Kuewumi adjourned the case to June 26.
The federal government suit came after a separate court delayed until July two cases brought by the Kano state government after Pfifzer lawyers did not appear in court.
A Pfizer spokesman in New York insisted that the firm's clinical trial of Trovan was conducted with the full knowledge of the Nigerian government and in a responsible and ethical way.
"These allegations against Pfizer, which are not new, are highly inflammatory and not based on all the facts," he said.
"We continue to maintain, in the strongest terms, 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."
A federal court in Manhattan dismissed a 2001 lawsuit by disabled Nigerians who allegedly took part in the study, but the case is under appeal.
About 15,000 people died in the epidemic, and children from a wide area were brought to Kano for treatment at its infectious diseases hospital, staffed by volunteer doctors from Médecins sans Frontières.
Pfizer set up a temporary clinic nearby and treated the 200 children, half of whom were given the new drug, a pill, and half the "gold standard" drug, cephtriaxone, given by injection.
Five of the children given Trovan died, together with six who were on the standard treatment.
Trovan has since been approved by the US food and drug administration but only for use in adults.
Authorities in Kano state blame the Pfizer controversy for widespread suspicion of government public health policies, particularly the global effort to vaccinate children against polio, which has met strong resistance in northern Nigeria.
Islamic leaders in largely Muslim Kano have seized on the Pfizer controversy as evidence of an American conspiracy. Rumours that polio vaccines spread Aids or infertility led to Kano and another heavily Muslim state, Zamfara, to boycott a long-term campaign to vaccinate millions.
Vaccination programs restarted in Nigeria in 2004, after an 11-month boycott. But the delay set back global eradication - the boycott was blamed for causing an outbreak that spread the disease across Africa and into the Middle East.
