NEW YORK -- Pfizer Inc. said the Nigerian federal government filed a civil lawsuit for $7 billion in damages against the drug maker, related to a study of an experimental meningitis treatment given to children.
Pfizer, the world's largest drug maker, denies all charges that it violated any laws or ethical standards when it gave the antibiotic, Trovan, to children there during an outbreak, spokesman Bryant Haskins said yesterday . This lawsuit is in addition to civil and criminal charges filed last month by officials in the Nigerian state of Kano.
Two hundred children received Trovan in Kano, Nigeria, in 1996, the company said.
The Nigerian government and Kano state government allege Pfizer gave the antibiotic to children without proper parental consent and that it disabled or killed some children.
Pfizer confirmed the charges filed in Abuja, Nigeria. Trovan was unapproved in the United States and Nigeria at the time and was never approved for use in children.
"These allegations against Pfizer, which are not new, are highly inflammatory and not based on all the facts," Haskins said in a statement yesterday . "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."
New York-based Pfizer may face an additional $2 billion in fines in connection with the lawsuit in Kano. A US court dismissed a lawsuit in 2005 filed by more than two dozen family members of the Nigerian children, Pfizer said. The families are appealing the ruling, Pfizer said.
The New York-based company's shares fell 16 cents to $27.52 in New York Stock Exchange trading.
Trovan was approved for adults in the United States in 1997 for 14 different uses, including treading infections caused by bacteria that can resist other drugs.
It is now discontinued, according the US Food and Drug Administration's website.
In 1999 the FDA warned doctors about possible liver damage from the drug, part of a class of powerful antibiotics known as fluoroquinolones.