Abdullahi v. Pfizer, Inc.

The Kano trovafloxacin trial litigation arose out of a clinical trial conducted by
the pharmaceutical company Pfizer in 1996 in Kano, Nigeria, during an epidemic
of meningococcal meningitis. To test its new antibiotic, trovafloxacin (Trovan), Pfizer
gave 100 children trovafloxacin, while another 100 received the gold-standard anti-
meningitis treatment, ceftriaxone, a cephalosporinantibiotic.[1] Pfizer gave the
children a substantially reduced dose of the ceftriaxone (specifically,
33mg/kg)[2] relative to that described on the US FDA-approved prescribing
information. The allegation is that this was done to skew the test in favor of its own
drug.[3] Pfizer claimed that the dose used was sufficient even though a clinical trial
performed by Médecins Sans Frontièresrecommends a dose of 50–100mg/kg.[4] A 2002
report by the World Bank described the military government that ruled Nigeria at the
time of these events as "pervasively corrupt". It further cites widespread comments by
business managers in Nigeria characterizing the National Agency for Food and Drug
Administration and Control (NAFDAC) of that period as lacking the capabilities needed
to perform its regulatory role and "harassing business and seeking bribes" rather than
"protecting businesses and consumers".[5]
Five children given trovafloxacin died, as did six of those given ceftriaxone. The lead
investigator, Dr. Abdulhamid Isa Dutse, later provided a letter of approval for human
trialsthat was found to be falsified.[1] The Nigerian government called the trial "an
illegal trial of an unregistered drug."[6] It has been alleged that participants and their
families were not told that they were part of a trial, and that Médecins Sans
Frontières was offering the standard treatment in another part of the same
building.[7] Pfizer acknowledged reducing the dose of the standard treatment, but said
this was done to minimize injection-site pain, and that the mortality rates in both the
trovafloxin and ceftriaxone arms of its trial were lower than among those treated
with chloramphenicol by Médecins Sans Frontières.[8]
The survivors of the trial tried to bring a number of legal actions against Pfizer in the
United States. These resulted in four judicial opinions, the first three dismissing the
claims on procedural grounds.[6] According to Ben Goldacre, Pfizer argued that it was
not required to obtain informed consent for experimental drug trials in Africa, and
that any case should be heard in Nigeria.[7] In May 2006 Representative Tom Lantos of
California, the senior Democrat on the House International Relations Committee,
described the findings of a report compiled about the case by the Nigerian government
as "absolutely appalling," and called for Pfizer to open its records.[6] In January 2009
the United States Court of Appeals for the Second Circuitruled that the Nigerian
victims and their families were entitled to bring suit against Pfizer in the United States
under the Alien Tort Statute. Pfizer subsequently settled the case out of court with a
$75 million settlement that was subject to a confidentiality clause.[7]
Overall, the 1996 meningitis epidemic in northern Nigeria killed about 12,000 people,
during the worst known meningitis outbreakin Sub-Saharan Africa.