A court case brought by Nigeria against Pfizer resumes on Wednesday with the U.S. drug maker saying it answered a call for help to save the lives of African children during a meningitis epidemic.
Nigeria alleges Pfizer deceived patients and caused the death of 11 children in 1996 when it performed clinical trials for a new drug. With the northern state of Kano, it is suing the company for $8.5 billion.
The meningitis outbreak killed more than 12,000 children in six months near Kano, a predominantly Muslim metropolis with a history of conflict with the West. Meningitis is an infection of the nervous system that can kill in hours if left untreated.
Ngozi Edozien, managing director of Pfizer in West Africa, said the company brought the experimental drug, Trovan, to Nigeria in response to an international plea for help.
There was a compelling reason to look at Trovan because it was an oral formulation, it was known to have shown efficacy in meningitis and was a five-day treatment so it was perfect for an epidemic setting, she told Reuters.
The test involved 200 children, half of whom received Trovan while the other half received a proven meningitis treatment.
Nigeria alleges Pfizer was responsible for the deaths of 11 children and permanent health problems for many others. It says it failed to obtain all the required approvals for the test and did not get proper consent from the patients.
Pfizer rejects all the charges. It says Trovan saved lives and the alleged victims were affected by meningitis, not the drug.
The case was first brought in the United States, but thrown out in 2005 by a judge who said it should be heard in Nigeria.
On Wednesday, Pfizer will be in two courts for civil and criminal proceedings brought by the Kano state government. The federal government has also brought civil and criminal charges.
Trovan had already been tested on 5,000 people before it was used in Nigeria, Edozien said.
It was licensed by the U.S. Food and Drug Administration for use on adults a few months after the Kano trial, and briefly became one of Pfizer's top-selling drugs.
However, the authorities imposed severe restrictions on its use three years later when it was found to cause serious liver injuries in some patients.
Mustapha Maisekili, the father of two alleged victims in the Kano trial, said his two daughters were walking and talking when he took them to the Infectious Diseases Hospital suffering from flu-like symptoms typical of meningitis.
They died a few weeks later.
Most of the victims lost hope of getting any form of justice on the issue, he said.
If we are compensated through the court judgment we shall be relieved somehow. Most of us are living hand-to-mouth.
Pfizer faces a hostile reception in Kano, a focus of Islamic radicalism in Nigeria with a history of religious bloodshed and rejection of Western medicine.
The state government banned vaccines against polio for nine months in 2003, alleging they contained HIV and were spreading infertility. The Kano boycott fuelled a resurgence of the crippling virus across Africa.
Civil rights groups say they are planning demonstrations against Pfizer in the city next week.
(Additional reporting by Tom Ashby in Lagos)