Article

WSJ: Court Revives Suit Against Pfizer On Nigeria Study

Tue, 14 Oct 2003

Follow up to earlier AHRP Infomail on this case.

The Wall Street Journal reports: “The suit against Pfizer is part of a growing trend in international law to try cases against multinational corporations in developed countries for alleged misdeeds committed in the developing world.”

The case involves allegations of informed consent violations.

Was the FDA aware of the consent process used by Pfizer to test Trovan on children in Nigeria?

The right to informed consent is a fundamental human and legal right which the judiciary takes very seriously. It would appear, however, that federal oversight agencies –Office of Human Research Protections and FDA– fail to enforce informed consent requirements by major American institutions–even when they have been caught in gross violation.

See documents relating to Harvard / Millenium Genetic experiments in China: http://www.ahrp.org/infomail/03/10/01.php

See documents relating to the ARDS Network experiments on lung injured patients: http://www.ahrp.org/infomail/03/07/07.php

The Wall Street Journal
October 13, 2003

HEALTH

Court Revives Suit Against Pfizer On Nigeria Study

By SCOTT HENSLEY
Staff Reporter of THE WALL STREET JOURNAL

A federal appeals court in New York has revived a lawsuit against Pfizer Inc. that alleges the pharmaceutical company improperly conducted a clinical study of an experimental antibiotic, treating Nigerian children stricken with meningitis seven years ago.

The plaintiffs include more than two dozen Nigerian families who allege their children were injured or died because Pfizer didn’t adequately inform them of the risks and alternatives for treatment with Trovan, an antibiotic, during a 1996 meningitis outbreak. The plaintiffs are seeking unspecified damages.

Last year, a federal judge in the Southern District of New York in Manhattan threw out the case, siding with a Pfizer motion that the U.S. courts weren’t appropriate or convenient for the trial. A panel of three judges for the U.S. Court of Appeals for the Second Circuit overturned that decision in a unanimous vote last week, and remanded the case to the district court.

A Pfizer spokesman said the New York-based company “strongly disagrees” with the decision that the case should be heard here and emphasized that the ruling didn’t concern the merit of the case. “We believe Trovan was a potentially innovative medicine for a major need in the developing world, and that Pfizer personnel acted in accordance with accepted international practice concerning clinical trials,” he said. The company says the case has no merit.

The suit against Pfizer is part of a growing trend in international law to try cases against multinational corporations in developed countries for alleged misdeeds committed in the developing world.

The appeals court “decision is a just one and will enable our clients to use the U.S. courts to hold an American company accountable for the harm they caused our clients in Nigeria,” said Melvyn Weiss, senior partner of Milberg Weiss Bershad Hynes & Lerach LLP, a New York law firm representing the plaintiffs.

The U.S. Food and Drug Administration approved Trovan in 1997. But after reports that Trovan led to liver damage in some patients, Pfizer essentially withdrew the medicine from the market in 1999, except for treatment of rare, life-threatening infections.

Pfizer tested Trovan during a meningitis outbreak in Kano, Nigeria. At the heart of the Trovan case are allegations that Pfizer failed to explain to the children’s parents that the proposed treatment was experimental, that they could refuse it, or that other treatments were available.

Write to Scott Hensley at scott.hensley@wsj.com

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