* Lawsuit said Pfizer failed to obtain adequate consent
* Company says it got consent, that Nigerian govt approved
* Pfizer says it is confident it will ultimately prevail
(Adds Pfizer reaction penultimate three paragraphs, case name
last paragraph, byline)
By James Vicini
WASHINGTON, June 29 The Supreme Court declined
to hear an appeal by Pfizer Inc (PFE.N) of a ruling that
reinstated U.S. lawsuits by Nigerian families who said the
drugmaker tested an experimental antibiotic on their children
without getting adequate consent.
The justices, without comment, let stand a ruling by a U.S.
appeals court in New York that allowed the lawsuits involving
alleged harm caused by the drug, Trovan, to go forward.
Pfizer conducted clinical trials of the drug in Nigeria
during a 1996 meningitis epidemic. Families of some of the
children who participated said the tests caused deaths and
According to the lawsuits, Pfizer violated international
law by failing to obtain adequate consent from the patients.
The lawsuits sought unspecified damages on behalf of the
children who were part of the study.
The drugmaker said the clinical study was conducted with
the approval of the Nigerian government and that it had the
consent of participants' parents or guardians. Pfizer said the
trial violated no international or Nigerian laws.
Pfizer said the appellate ruling expanded the jurisdiction
of the Alien Tort Statute, a more than 200-year-old law, to
American corporations doing business abroad, raising issues of
national and international importance.
A federal judge initially dismissed the lawsuits, ruling
the cases should be heard in Nigeria, not the United States.
In 1998, the U.S. Food and Drug Administration approved
Trovan for use by adults only. After reports of liver failure,
its use in the United States was restricted to adult emergency
care. The European Union banned its use in 1999.
The Obama administration urged the justices to reject
Pfizer's appeal, saying the questions presented did not warrant
Supreme Court review.
Pfizer said in a statement, "Today's decision, however, is
not a determination on the merits of these cases, but rather a
It said the cases will go back to a federal judge in New
York, where the company can again move to dismiss them on
various grounds, including that Nigeria would be the
appropriate place for the cases to be heard.
"The company looks forward to presenting its defenses in
court and remains confident it will ultimately prevail in these
cases," Pfizer said.
The Supreme Court case is Pfizer Inc v. Abdullahi, No.
(Reporting by James Vicini; Editing by Gerald E. McCormick,
Dave Zimmerman and Steve Orlofsky)