Wednesday, February 23, 2011

Ethics of Clinical Trials: Update on Trovan and Pfizer

From PharmaLot (http://www.pharmalot.com/2010/06/nigerians-can-proceed-with-their-pfizer-lawsuits/):

Nigerians Can Proceed With Their Pfizer Lawsuits
3 Comments
By Ed Silverman // June 29th, 2010 // 10:16 am
The US Supreme Court has rejected an appeal by Pfizer to overturn a ruling that reinstated lawsuits filed by Nigerian families, who say the drugmaker tested an experimental antibiotic on their children without getting adequate consent. Earlier this month, the US Solicitor General filed a brief arguing the Supreme Court should not bother to hear the case.
At issue was the Alien Tort Statute, which has been relied upon to claim US companies committed eggregious behavior overseas, and was cited by several Nigerian families who accuse Pfizer of international humans rights law in connection with the 1996 Trovan study. The trial was conducted on about 200 children during a meningitis epidemic that killed 12,000 children.
Pfizer was accused of failing to obtain proper regulatory approval and misleading parents. The study allegedly left 11 children dead and the others were deformed. Pfizer denied the charges and settled the bulk of litigation this summer by agreeing to pay $75 million to settle civil and criminal charges brought by the Kano State government in Nigeria.
The appeal was closely watched, in part, because it raised points that are important to multi-national corporations - whether such a company can be sued under the Alien Tort Statute and whether violations of this statute encompass activities conducted overseas. A federal judge had dismissed the case and ruled the lawsuits should be heard in Nigeria, before an appeals court overturned that ruling.
UPDATE: Pfizer writes to say the drugmaker is “disappointed with the Supreme Court’s order. Today’s decision, however, is not a determination on the merits of these cases, but rather a procedural ruling. The Supreme Court order returns the cases for further consideration to the District Court, where the company has reserved its right to again move to dismiss the cases on various grounds, including the fact that Nigeria is the appropriate forum for the cases to be heard.
“Pfizer continues to believe that the Court of Appeals’ decision represents an unprecedented expansion of international law by allowing non-U.S. citizens to bring a wide range of lawsuits in U.S. courts that have not been recognized before. The company looks forward to presenting its defenses in court and remains confident it will ultimately prevail in these cases.
“Pfizer stands by its 1996 Trovan clinical study, which the company has said all along was conducted with the approval of the Nigerian government, the consent of the participants’ parents or guardians, and was consistent with Nigerian laws.”

1 comment:

  1. It's also worth noting that Pfizer employed some less than ethical tactics in the defense of this case:
    http://www.guardian.co.uk/business/2010/dec/09/wikileaks-cables-pfizer-nigeria

    The cable reports a meeting between Pfizer's country manager, Enrico Liggeri, and US officials at the Abuja embassy on 9 April 2009. It states: "According to Liggeri, Pfizer had hired investigators to uncover corruption links to federal attorney general Michael Aondoakaa to expose him and put pressure on him to drop the federal cases. He said Pfizer's investigators were passing this information to local media."

    The cable, classified confidential by economic counsellor Robert Tansey, continues: "A series of damaging articles detailing Aondoakaa's 'alleged' corruption ties were published in February and March. Liggeri contended that Pfizer had much more damaging information on Aondoakaa and that Aondoakaa's cronies were pressuring him to drop the suit for fear of further negative articles."

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