Nigeria sues Pfizer over child deaths in 'illegal' drug trial

Nigeria has filed new charges against Pfizer, seeking $6.95bn in damages over the deaths of children who received an unapproved antibiotic during a meningitis epidemic.

The suit came after a separate court delayed until July two cases in which Pfizer is accused by the northern state of Kano of harming Nigerian children by testing them with Trovan (trovafloxacin) in 1996. Although the Kano state government case has been running for more than two years, this is the first time the federal government filed its own charges.

In papers filed at a Federal High Court in the capital Abuja, Nigeria alleges that Pfizer did not obtain approval from the relevant regulatory agencies and acted unethically when it tested the antibiotic in Kano. '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.

After taking preliminary arguments from counsels to both parties, Justice Babs Kuewumi adjourned the case to June 26 for further hearing. Pfizer denies the allegations.

Bryant Haskins, a Pfizer spokesman in New York, reiterated that Pfizer'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.'

Kano state government has filed criminal charges and a civil lawsuit seeking $2.075bn in damages from Pfizer over the tests which it alleges caused the deaths of some children and permanent health problems for others. Nigeria is seeking $500m for what the government claims to have spent on treatment, compensation and support for the Trovan victims and their families, and $450m for public education to erase social misgivings that arose from the ill-fated tests.

The government says it spent $1bn on a health programme that failed because of the misgivings caused by the Trovan tests, while it is claiming $5bn in general damages.

The cases in Kano were due to come up for hearing on 4 June at a state high court but no representative of Pfizer was present in court. The judge adjourned the civil case to 4 July 4 and the criminal case to 9 July. Haskins said company lawyers did not attend the hearing because Pfizer had not been served notice of the proceeding, and that the cases were postponed for that reason.

The legal dispute has been going on for years. In 2005 a US federal judge dismissed a lawsuit that accused Pfizer of not properly warning Nigerian families about the risk of Trovan, saying it should be heard in a Nigerian court.

Pfizer has said the clinical trial was conducted 'in a responsible and ethical way consistent with the company's abiding commitment to patient safety'. At the time of the meningitis outbreak, Trovan was in late-stage development and had been evaluated in 5,000 patients, it said.

The US FDA cleared Trovan for adult use in 1997 but did not approve the drug for use by children. The drug was approved by the EU in 1998 but marketing authorisation was suspended the following year after 152 reports of serious hepatic events, including nine deaths.