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[india-drug] Important Judgement in lawsuit in Nigeria(1)


  • From: "Sangeeta Sharma" <sharmasangeeta2003@yahoo.com>
  • Date: Sun, 13 Jan 2008 23:30:56 -0800 (PST)

Important Judgement in lawsuit in Nigeria(1)
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Dear All,

Please find below an important judgment in a lawsuit in FDA Daily Drug Bulletin Vol. 5, No. 8
Monday, Jan. 14, 2008

Sangeeta Sharma
professor & Head
Dept of Neuropsychopharmacology
IHBAS

Pfizer Official Arrested in Nigeria Over Clinical Trial
The former medical director of Pfizer in Nigeria was arrested, and
warrants are out for other former company officials in an ongoing civil and
criminal lawsuit over the company?s 1996 pediatric clinical trial of
its antibiotic Trovan.

Pfizer did not say how many people are subject to arrest under the
judge?s orders, nor did it give any names, but the local newspaper
Leadership in Abuja, Nigeria, said former Pfizer Nigeria Managing Director
Ngozi Edozien is on the list along with
senior official Segun Dogunro and six others. Pfizer is challenging
the validity of the arrest order issued by the judge in Kano in late
December 2007.

In May 2007, Nigerian authorities took legal action against the company
over the 1996 pediatric clinical trial of Trovan (trovafloxacin)
during a meningitis outbreak. Nigerian federal officials have joined with
state officials in Kano in suing for $700
million to $2 billion in damages and restitution, according to various
reports.

The lawsuit, which names current and former Pfizer executives, clinical
investigators and the company?s local subsidiary as defendants,
alleges that the parents were not informed that their children would take
part in a clinical trial and that
alternative treatments were available.

?Pfizer continues to emphasize, in the strongest terms, that the 1996
Trovan clinical trial helped save lives, was conducted with the
approval of Nigerian authorities [and] consent of the families involved and
[was] consistent with the laws of Nigeria,?
Pfizer spokesman Chris Loder said.


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