PETER ROST: PHARMA MARKETING EXPERT WITNESS. AWP, MEDICAL DEVICE EXPERT.: 2nd Circuit Revives Nigerian Families' Claims Against Pfizer Over Drug Tests
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2nd Circuit Revives Nigerian Families' Claims Against Pfizer Over Drug Tests

Daniel Wise
02-02-2009

African families' damage claims for billions of dollars against Pfizer for allegedly secretly testing a new drug in a Nigerian hospital during a 1996 meningitis outbreak were revived Friday by a divided federal appeals court.

The ruling allows 88 Nigerian families to pursue claims under a law adopted in 1789 that gives foreigners the right to raise tort claims in federal court to vindicate violations of "the laws of nations."

In 89 pages containing numerous barbed comments, the 2nd U.S. Circuit Court of Appeals majority and dissent differed over whether the families' claims that their children had been subjected to medical experimentation without their consent fell within the 18th-century law.

In concluding that the law embraces claims of unconsented medical experimentation, Judge Barrington D. Parker wrote for the majority that the dissent took an approach to "customary" international law that is "unselfconsciously reactionary and static."

In dissent, Judge Richard C. Wesley described the majority as creating a new norm "out of whole cloth" upon the basis of "materials inadequate to the task."

The families claim Pfizer recruited 200 Nigerian children who were felled by meningitis during the epidemic, and treated half of them with a new antibiotic, Trovan. The other half, they allege, were given Ceftriaxone, an FDA-approved drug.

The test went forward, according to the plaintiffs, without the families being told the nature of the experiment or possible life-threatening side effects of using Trovan. They also charge that a deliberately low dose of Ceftriaxone was administered to boost the apparent effectiveness of Trovan.

According to the families, the experiment resulted in the deaths of 11 children and left many others blind, deaf, paralyzed or brain damaged.

In a statement Friday, Pfizer said its 1996 clinical study was conducted with the consent of the children's parents and "was consistent with both international and Nigerian laws."

Any deaths or injuries were "the direct result of the illness, and not the treatment provided to patients in the Pfizer study," the company stated.

The drug maker expressed confidence it will prevail and said it is weighing its legal options.

The case may yet be heard in Nigeria because the 2nd Circuit, upon the agreement of the parties, did not review that portion of Southern District of New York Judge William H. Pauley's ruling dismissing the case on the ground of forum non conveniens.

Pfizer advised the circuit that it would not seek affirmance on that ground, citing what the opinion described as "a tectonic change" in the political landscape in Nigeria.

In mid-2007, the Nigerian government sued Pfizer for $7 billion and the state of Kano in northern Nigeria, where the children were treated, brought criminal and civil cases against Pfizer.

Peter Safirstein of Milberg, who is representing 30 families, said none of the Nigerian lawsuits seeks to recover damages for individuals. He added that the Southern District suit does not specify a damages figure.

Richard Altschuler, of Altschuler & Altschuler in West Haven, Conn., said he is seeking to recover $2 billion in damages for the 58 families he represents.

The appeal of the two cases was consolidated under the caption, Abdullahi v. Pfizer, 05-4863 and 05-6768.

LAW NARROWLY INTERPRETED

Both the majority and dissent recognized that the 1789 law, the Alien Tort Statute, 28 U.S.C. §1350, has been narrowly interpreted.

Judge Parker described the statute as providing jurisdiction in just two cases in its first 190 years. The law has been construed "slightly more robustly" in the next 30, he added. Both Parker and Judge Wesley noted that the leading U.S. Supreme Court case construing the act, Sosa v. Alvarez-Machain, 542 U.S. 692 (2004), requires "vigilant gatekeeping."

In concluding that claims of unconsented medical experimentation are cognizable under the act, Parker cited the first principle of the Nuremberg Code, which states that in medical experiments, "the voluntary consent of the human subject is absolutely essential."

The 10-principle code was formulated as part of a war crimes trial conducted after World War II in which 15 doctors were convicted of crimes against humanity for conducting unconsented experiments. Seven of the doctors were sentenced to death.

"History illustrates that from its origins with the trial of Nazi doctors at Nuremberg through its evolution in international conventions, agreements, declarations and domestic laws, the norm prohibiting nonconsensual medical experimentation on human subjects has become firmly embedded and secured universal acceptance in the community of nations," Parker wrote.

Judge Rosemary Pooler joined the majority.

But Wesley contended the Nuremberg trials and the international agreements cited by the majority did not establish a private right of action against non-state actors.

The Nuremberg cases, he wrote, were "premised primarily, on the defendants' forced medical experiments, which constituted war crimes when performed on prisoners of war and crimes against humanity when conducted on Nazi concentration camp prisoners."

While the plaintiffs "paint a picture of unbelievable pain and suffering," they have not alleged those "rare acts by private individuals" that the world has "collectively" determined are "so serious as to threaten the very fabric of international affairs."

Pfizer was represented by Steven Glickstein, David Klingsberg, Maris Veidemanis, James D. Herschein and Julie B. du Pont of Kaye Scholer.

Elaine S. Kusel, Ann M. Lipton, Andrew Wilmar and Tatiana Rodriquez worked with Safirstein of Milberg, and Ali Ahmad worked with Altschuler.

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