|
|
The central events at issue in this lawsuit occurred in 1996, not long after epidemics of bacterial meningitis, measles and cholera broke out in Kano, Nigeria. Pfizer established a treatment center at the Infectious Disease Hospital in Kano to treat victims of the meningitis epidemic. Plaintiffs allege that Pfizer, instead of using safe and effective bacterial meningitis treatments, used the epidemic as an opportunity to conduct biomedical research experiments on Nigerian children involving Pfizer’s “new, untested and unproven” antibiotic, trovaflozacin mesylate, better known by its brand name, Trovan®.”
Plaintiffs charge Pfizer with violating the Nuremberg Code, the Declaration of Helsinki, article 7 of the International Covenant on Civil and Political Rights, FDA regulations and other norms of international law.
“Plaintiffs claim that Pfizer failed to explain to the children’s parents that the proposed treatment was experimental, that they could refuse it, or that other organizations offered more conventional treatments at the same site free of charge. Id. at *2. In addition, plaintiffs assert that half of the children who participated in Pfizer’s treatment program were deliberately given inadequate doses of ceftriaxone—an FDA-approved drug shown to be effective in treating meningitis—so that Trovan would look more effective by comparison. Id. According to plaintiffs, five of the children who received Trovan and six of the children who were “low-dosed” with ceftriaxone died and others treated by Pfizer suffered very serious injuries, including paralysis, deafness and blindness. Id.”
At issue was whether Plaintiffs could obtain justice in a Nigerian Court—which they documented, they could not.
The case, Abdullahi v. Pfizer, Inc., No. 02-9223 (2d Cir. 10/08/2003) Nos. 02-9223 (L), 02-9303 (XAP) October 8, 2003 See: http://biotech.law.lsu.edu/cases/research/Abdullahi_v_Pfizer.htm
The case may signal to pharmaceutical companies that human beings even in countries ruled by corrupt oppressive regimes, are entitled to human rights protection afforded by international ethical research guidelines.
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
http://www.ahrp.org
Contact: Vera Hassner Sharav
Tel: 212-595-8974
e-mail: veracare@ahrp.org
|
|
|
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
|
