Posted by Anthony Lin, New York Law Journal on
A federal judge in Manhattan has dismissed for a second time class action claims against drug maker Pfizer Inc. by Nigerian families who claim the company put their children in dangerous drug trials without consent.
* Claims under Alien Tort Act rejected
A federal judge in Manhattan has dismissed for a second time class action claims against drug maker Pfizer Inc. by Nigerian families who claim the company put their children in dangerous drug trials without consent.
Citing a decision last year by the U.S. Supreme Court that limited the types of claims that could be brought under the Alien Tort Statute, Southern District of New York Judge William Pauley said the Nigerians' claims were not covered by the law.
"While this Court may disapprove of Pfizer's actions, it must apply established law -- not some normative or moral idea," he wrote in Abdullahi v. Pfizer, 01 Civ. 8118.
The torts statute, also known as the Alien Tort Claims Act, has in recent years become a favorite instrument of plaintiffs seeking redress for alleged human rights violations by U.S. companies operating abroad. Many such suits have alleged U.S. corporations were complicit in murder and torture carried out by foreign regimes.
The 2001 suit against Pfizer arose from tests the pharmaceutical giant conducted in 1996 during an outbreak of meningitis in Kano, Nigeria.
The plaintiffs say Pfizer, which set up a treatment center for children at a Kano hospital, used the antibiotic Trovan, then awaiting FDA approval, on some patients, instead of using an approved drug, ceftriaxone. For the purpose of comparison, Pfizer allegedly used lower-than-recommended doses of ceftriaxone in treating other patients.
According to the plaintiffs, Pfizer did not tell the children's parents they would use an experimental drug or that they could refuse that treatment. They claim 11 children died as a result of Pfizer's actions and others suffered paralysis, blindness and deafness.
Pfizer has consistently denied the allegations. Spokesman Bryant Haskins said the Trovan trials adhered to the highest standards of medical ethics and safety and claimed the mortality rate with Pfizer's treatments was lower than would have been the case with other treatments.
The plaintiffs claim that Pfizer's alleged conduct of the trial without the consent of the patients' parents violated international law as embodied in international compacts on medical ethics, including the 1947 Nuremberg Code and the World Medical Association's 1964 Declaration of Helsinki, as well as the International Covenant on Civil and Political Rights and the Universal Declaration of Human Rights. The plaintiffs also claim Pfizer violated FDA regulations and customary international law.
Judge Pauley first dismissed the suit in 2002 solely on the grounds that Nigeria was the proper forum for the suit. But the 2nd U.S. Circuit Court of Appeals remanded the case in 2003 and directed the trial court to further consider evidence that bias and corruption in the Nigerian court system meant it was not an adequate alternative to U.S. courts.
In his most recent decision, the judge dismissed the suit for lack of subject-matter jurisdiction, citing the U.S. Supreme Court's June 2004 decision in Sosa v. Alvarez-Machain, 542 U.S. 692.
In Sosa, the Court ruled that, though some claims charging violations of international law could be brought under the Alien Tort Statute, it would not support claims based on international laws "with less definite content and acceptance among civilized nations" than those in place when the statute was adopted in 1789.
Examples of universally accepted customary law cited by the Court included international laws governing treatment of diplomats and dealing with acts of piracy on the high seas.
Pauley said the sources of international law cited by the plaintiffs did not rise to that level. He noted that the Nuremberg Code had not been adopted by many prominent states and had never been adopted by the United Nations.
He said the Declaration of Helsinki as well as guidelines on human experimentation by the Council for International Organizations of Medical Sciences were vague policy statements that did not contain the specificity required by the torts statute. He found the International Covenant on Civil and Political Rights and the Universal Declaration of Human Rights similarly lacking.
Noting that none of the international declarations by the plaintiffs specified a private right of action, Pauley said the decision to create such a right rested with Congress.
"[T]his Court will not judicially forge broad aspirational language into customary international law," he wrote.
NIGERIA AS FORUM
Further consideration of the issue of bias and corruption in Nigerian courts also did not change Pauley's view that Nigeria offered an adequate forum for the plaintiffs.
Citing several other federal court decisions, Pauley said news articles and State Department reports expressing concern about corruption in foreign courts were not sufficient evidence to establish that such foreign courts were inadequate forums.
The 2nd Circuit had remanded the case over allegations that a parallel proceeding in Nigeria had to be withdrawn owing to indefinite delay. But Pauley said there was no evidence the delay in the case was indefinite and he said the plaintiffs' own failure to appear on occasion contributed to the delay.
The judge said there was also no evidence of corruption being behind the delay. He noted plaintiffs had advanced allegations of bribery of Nigerian officials by Pfizer, but he said these allegations were hearsay and could not be credited.
Elaine Kusel of Milberg Weiss Bershad & Schulman, the lawyer for the plaintiffs, said she and her clients would appeal the decision. She said the grounds for her clients' suit remained valid even under the Sosa ruling.
"We think he got it wrong and we're very disappointed," she said.
Pfizer was represented by Steven Glickstein of Kaye Scholer.