Saturday, June 2, 2007

Nigerian state files criminal suit against Pfizer

By Mike Oboh

KANO, Nigeria (Reuters) - A Nigerian state has filed criminal charges against Pfizer Inc. for its alleged role in the deaths of children who received an unapproved drug during a meningitis epidemic, court papers showed on Wednesday.

Pfizer, the world's biggest drug maker, said in a statement the allegations of negligence are untrue and it acted ethically when it tested the antibiotic Trovan in Kano state in 1996.

The director of public prosecutions of Kano, in northern Nigeria, filed eight criminal charges before a state high court. The accused are Pfizer, its Nigerian subsidiary and eight individuals who worked for the companies at the time.

The case will have its first hearing on June 4.

Separately, the attorney general of the state filed a civil lawsuit seeking $2.075 billion in damages from Pfizer.

"The accused persons ... caused an untested and unregistered drug ... to be administered on about 200 patients without an informed consent from parents," said the criminal charge sheet, adding that they had acted in a "rash and negligent manner".

"The acts of the accused persons endangered human lives by causing side-effects (such) as deafness, muteness, paralysis, brain damage, loss of sight, flawed speech and even death," the document added in a "summary of evidence".

Officials in Kano have alleged for years that Pfizer's actions resulted in the deaths of some of the children and left others with permanent health problems.

The state government alleges Pfizer selected children and infants from crowds at a makeshift epidemic camp and gave about half of the group Trovan, which it says was untested at the time.

The legal dispute has been going on for years. A U.S. federal judge in 2005 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 said the clinical trial was conducted with the full knowledge of the Nigerian government "and in a responsible and ethical way consistent with the company's abiding commitment to patient safety".

The company said that at the time of the meningitis outbreak, Trovan was in late-stage development and had been evaluated in 5,000 patients.

The Washington Post newspaper in the United States said it obtained internal Pfizer records that showed five children died after being treated with Trovan. However, "there is no indication in the documents that the drug was responsible for the deaths. Six children died while taking the comparison drug," the paper said.

The U.S. Food and Drug Administration cleared Trovan for adult use in 1997 but did not approve the drug for use by American children.

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