With the recent ruling of a US Federal Appeals Court, a quick settlement of the cases between Pfizer and victims of the 1996 Trovan clinic trial may be endangered if the plaintiffs decide to go back to the starting blocks in the US
By Oluokun Ayorinde /Abuja
On 30 January, the second US Circuit Court of Appeals overturned a previous ruling by a lower court in a suit filed, in 2001, by lawyers representing families of the patients who took part in the 1996 Trovan trial in Kano. In the suit filed at the lower court, the lawyers asked for unspecified damages from Pfizer, the American pharmaceutical giant and makers of Trovan, claiming that the trial of the drug in Nigeria led to the death of 11 children in addition to causing brain damage and crippling arthritis to many others.
Lawyers representing the Nigerian families also claimed that Pfizer failed to obtain necessary approvals from appropriate regulatory authorities in Nigeria before it embarked on the drug test in the country. But the lower court dismissed the suit on the ground that it should be filed in Nigeria and not the United States of America. But in a split ruling, Circuit Judge Barrington D. Parker noted: “The administration of drug trials without informed consent on the scale alleged in the complaints poses a real threat to international peace and security.” This allowed Nigerian families, whose members were victims of the drug trial, to sue Pfizer in US courts.
The Federal and Kano State governments also filed a suit against Pfizer in the country. The suit, in which both governments are asking for over $8 billion as compensation for patients who suffered injuries as a result of the test, is currently running in five Nigerian courts because of appeals and counter-appeals. Pfizer has already described the ruling as procedural, as it does not dwell on the merits or otherwise of the litigants’ claims. “It is not a determination on their merits,” the American drug manufacturer said of the appellate court’s judgement. “Indeed, the strong dissent by one of the judges may be grounds for further appellate proceedings. Pfizer remains confident that it will prevail in these cases and is weighing its options on how to best respond to this decision,” the company added. It also insisted that it conducted the Trovan trial in Nigeria after securing all the necessary approvals from regulatory authorities and the consent of the participants’ parents or guardians. Indeed, papers filed in its defence in Nigerian courts copiously state this fact. The company also insisted that with a survival rate of 94.4 per cent, Trovan helped save lives and was at least as effective as the best treatment available at Kano’s Infectious Diseases Hospital. Last week, this magazine gathered that there are fears of another long drawn suit in the United States if Pfizer decides to exploit all its options. “Even this case that was just decided was filed way back in 2001. You can then imagine how long it will take if the issues are to be freshly decided on their merits and all the parties call different experts to testify in support of their arguments,” said a source close to the parties.
The pursuit of claims against Pfizer in the US courts will also be a setback to the current out-of-court negotiations between Pfizer and the Nigerian government, which has already got to an advanced stage. Some of the lawyers who sued on behalf of the patients are already giving this indication. Though he agreed that negotiations for out-of-court settlement between Pfizer and the Nigerian government have so far been productive, Babatunde Irukera, one of the lawyers who filed the US suit, said the judgment of the appellate court may undo the process if families of patients involved in the trial decide to pursue a separate remedy in the United States.
Apart from compensation to families of participants, the Pfizer settlement offer, as this magazine learnt, includes rehabilitation of Kano’s Infectious Diseases Hospital and training of medical personnel employed by the Kano State government. All these will have to wait if the participants decide to pursue compensation in the US court. This, certainly, will be bad news for the families of patients, who are said to be already displeased with the back-and-forth way the suit in the Nigerian court has gone. Indeed, close watchers of the Trovan saga have advised that the best option for the patients is to carry on with settlement talks instead of embarking on a wild goose chase in America, with the risk of losing out at the end of the day.
But on its part, Pfizer had indicated that it remained committed to the current talks. “We continue to be interested in an amicable settlement that would help improve and expand healthcare for the people of Nigeria . The settlement process is ongoing and we are prepared to stay at the negotiating table until we reach such an agreement,” Chris Loder, Pfizer spokesman, said in a statement released in New York .
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