June 30, 2010

U.S. court rejects Pfizer’s appeal on drug test in Nigeria

AN appeal by Pfizer at the United States (U.S.) Supreme Court challenging the decision of a U.S. Court of Appeal that it can be sued for illegally testing an antibiotic drug, Trovan, in Nigeria in 1996 failed yesterday.

The U.S. Supreme Court refused to consider Pfizer Inc.’s case brought before it last year, after the court had asked the U.S. government to wade into the matter through the office of the U.S. Solicitor-General.

Besides, the Abuja Division of Federal High Court yesterday ordered Pfizer to put on hold the ongoing disbursement of about N50 billion compensation to victims of its 1996 clinical trial of the Trovan vaccine in Kano State.

The court also directed that the DNA test being conducted by the Health Care Meningitis Trust Fund Ltd to determine the real victims of the controversial Trovan vaccine test be halted.

A federal trial judge in New York threw out the lawsuits in 2005, ruling that international law didn’t provide a basis for the plaintiffs to sue Pfizer in U.S. courts for the alleged clinical-trial violations. But a divided second U.S. Circuit Court of Appeals revived the lawsuits last year, deciding that the plaintiffs could proceed with the case.

The Supreme Court, without comment, yesterday simply let the Appeal Court’s ruling stand. On occasions, the U.S. Supreme Court does adopt the practice of simply ignoring a case after accepting written arguments from both sides. And by ignoring the case, the U.S. highest court allows the pending decision to stand, like the previous ruling in this case made by the Appeal Court.

Last November, the U.S. Supreme Court asked the Obama administration through its Solicitor-General, Elena Kagan to file an opinion in the case to enable it to determine what to do with the case. Kagan herself is now being considered by the U.S. Senate to become a U.S. Supreme Court.

The Nigerian respondents in the case led by Rabi Abdullahi had earlier through their New York-based lawyer Arthur Miller submitted a brief to the Supreme Court, opposing Pfizer’s appeal against the U.S. Court of Appeal that ruled in favour of the Nigerians.

After the court of first instance, U.S. District Court in New York, ruled in favour of Pfizer, the Appeal Court reversed the decision. According to the Second U.S. Circuit Court of Appeals in New York, “the norm prohibiting non-consensual medical experimentation on human subjects has become firmly embedded and has secured universal acceptance in the comity of nations.”

The Nigerian respondents had sued Pfizer for the illegal testing of Trovan on children in Kano. The district court in New York presided over by Mr. J. Pauley dismissed the case for lack of jurisdiction, adding that international law didn’t provide a basis for the Nigerians to sue the company in U.S. courts for the alleged clinical-trial violations.

But the Nigerians with the backing of some New York-based civil right lawyers proceeded to the Appeal Court, where in January this year, through a majority but divided 2-1 decision ruled that the Nigerians could indeed sue and set aside the decision of the lower court, rescinding it and remanding the case back to the lower court for continued hearing.

Dissatisfied, Pfizer took the matter to the American apex court in July. In the appeal, Pfizer got two additional amicus briefs, to support its case, arguing that the Appeal Court in its judgment was legislating, and usurping the powers of the U.S. Congress.

United States (U.S.) district courts are the equivalent of Nigeria’s state or federal high courts.
Therefore, the Nigerian respondents submitted that the Appeal Court decision didn’t conflict with other U.S. circuits regarding the questions Pfizer raised in its petition.

In their brief filed before the Supreme Court, the Nigerians said: “The highly unusual and discrete facts of this case make any decision rendered of limited precedent value, as it will turn on the assessment of factual allegations particular to this case and the pleading of a claim that present circumstances not likely to be repeated.”

They said Pfizer was not arguing that consent was not required, “but instead attempts to characterise its misconduct as mere technical failure in obtaining consent,” adding that “such mis-characterisation obscures Pfizer’s violations of basic human rights principles governing that conduct, with or without the presence of state action.”

The respondents also alleged “that Pfizer, despite knowing that Trovan had the potential to cause serious side effects in children, rushed at the opportunity to test them on children struck ill by a sudden bacterial meningitis epidemic in Northern Nigeria in 1996.”

They recalled that Pfizer occupied two wards of the Kano Infectious Diseases Hospital (IDH), a public hospital, to conduct the Trovan experiment and that these facilities were handed over to Pfizer by the Nigerian government.

The respondents added that at the time of the Trovan testing, the Nobel Prize winning body Medecins Sans Frontieres (MSF), also on location during the epidemic, deemed the same “facilities unfit for its own treatment efforts.”

Describing Pfizer’s lack of attention to appropriate consent as appalling, the Nigerians noted that the drug outfit “failed to inform families either that the treatment offered was experimental, or that MSF offered a non-experimental treatment recommended by the World Health Organisation. Moreover, no representative of Pfizer offered or read any informed consent document to respondents.”

They, therefore, submitted to the U.S. Supreme Court that “Pfizer’s misconduct represents a gross violation of international legal norms prohibiting nonconsensual medical experimentation. These norms have been universal and well-defined since, at the latest, the years following World War II.”

Continuing, the respondents stated that “although arguably no specific treaty makes Pfizer’s misconduct actionable, seminal international human rights documents as well as internationally accepted codes governing the practice of medicine and medical experimentation specifically make clear that the norm applies to private actors. Pfizer does not, and cannot, argue that it is not bound by the norm and is free to conduct nonconsensual medical experimentation anywhere at any time.”

In essence, the two groups of Nigerian families have been arguing for a while now in U.S. courts that Pfizer violated international law when it tested the experimental drug Trovan on 200 Nigerian children during a bacterial-meningitis outbreak. The Nigerian plaintiffs alleged that Pfizer conducted the clinical trial without proper consent from the children’s guardians and didn’t disclose the experimental nature of the study or the serious risks involved.

The clinical trial caused the deaths of 11 children and left others blind, deaf, paralyzed or brain-damaged, the plaintiffs alleged.

Pfizer said its Trovan study, conducted in the Nigerian state of Kano, took place with the approval of the Nigerian government and the consent of the children’s parents. The drug maker said any deaths were the result of illness, not of the clinical trial.

In 1998, the U.S. Food and Drug Administration approved Trovan for adult use only, and its usage has since been restricted to only emergency care. The drug was banned in the European Union.

The case, Pfizer v. Abdullahi, has caught international attention as Pfizer has been fighting to terminate it with as much legal muzzle. But now, the case will proceed back to the lower court where if successful heavy damages may be imposed on Pfizer in addition to those which Pfizer has already suffered in Nigeria.

Delivering his ruling on an oral application for a preservative order sought by Etigwe Uwa (SAN) on behalf of 192 victims, Justice Gabriel Kolawole of the Abuja Division of Federal High Court yesterday held that the order became necessary to prevent the case of the plaintiffs from destruction.

The court held that should the compensation be effected during the pendency of the case, the 192 victims might be left in the cold and unprotected in the deal.

Justice Kolawole held that victims have rights to justice and that nothing would be lost by all the defendants in the fresh suit upon the new order.

The action of the court was prompted by the refusal of some defendants to make undertaking that they would not take any action on the disputed money and the test while the case subsists.

Similarly, the court also took judicial notice of the failure of the defendants to file their response in respect of the case since May 26, 2010 when the court ordered them to do so.

The defendants are the Healthcare Meningitis Trust Fund Ltd, the Attorney General of Kano State, Pfizer Incorporated, Pfizer Specialties Ltd, David Odiwo, the Attorney General of the Federation and Corporate Affairs Commission (CAC).

About 200 victims were registered in 1996 some of who were said to have either lost their lives or suffered permanent disability when the alleged drug was administered on them to protect them against the meningitis infection.

However, upon agreement for compensation for the victims in place of further court actions, the figures of victims rose to 597.

Attempts by the Trust Board in charge of the fund to conduct DNA test to determine the real victims were opposed by the new victims on the ground that they could not trust the conduct of any test now especially 14 years after some fluids for tests were removed from their bodies.

Justice Kolawole while ordering that the case be preserved in the interest of justice adjourned hearing till July 20, 2010.

He ordered that all necessary papers must be filed and exchanged by the parties in the suit seven days to the adjourned date to prevent unnecessary delay.


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