A US federal appeal court has reinstated lawsuits by Nigerian families against Pfizer in a move that could have wide ranging implications for companies conducting clinical trials abroad.
The US Court of Appeals for the Second Circuit overruled a lower court’s findings by two votes to one, which opens the door for 88 Nigerian families to pursue their claims against Pfizer in US courts.
Under a law adopted in 1789, foreigners may pursue claims in federal courts if the violations were against “the law of nations”. If the decision is upheld it creates the possibility that more clinical trials conducted abroad could result in lawsuits taking place on US soil.
Strong views were put across by judges on both sides of the argument and further proceedings could still result in this latest decision being overturned. For that to happen it will rely on others sharing the viewpoint of Richard Wesley who was the dissenting voice on the three judge panel.
Wesley wrote: "I conclude that non-consensual medical experimentation by private actors, though deplorable, is not actionable under international law and would therefore affirm the district court's dismissal of Plaintiffs' complaints."
Currently it remains a legal uncertainty and something for those conducting clinical trials abroad to keep tabs on. However, for Pfizer this is the latest twist in a long running saga.
Pfizer maintains it is innocent of wrongdoing but the fallout from the 1996 Trovan (trovafloxacin) clinical trial is still on going, with both the Nigerian government and families pursuing the pharma giant.
The company recruited 200 children to take part in the trial but their families claim they were not informed of the nature of the experiment or possible life-threatening side effects of Trovan.
In addition it is claimed that low doses of the approved drug Ceftriaxone were administered to artificially inflate the apparent effectiveness of Trovan.
The families claim that the trial resulted in the deaths of 11 children and left many others blind, deaf, paralysed or brain damaged.
Pfizer believes that deaths and injuries that occurred were a direct result of a meningitis epidemic and points to the survival rate for patients taking Trovan, which it claims shows the treatment was at least as effective as any other available.