Supreme Court Seeks Pfizer Trovan Comment
1 CommentBy Ed Silverman // November 5th, 2009 // 7:53 am
The US Supreme Court has asked the Justice Department’s Office of the Solicitor General to file a brief in a controversial case in which Nigerians are suing the drugmaker over 11 deaths and dozens of other injuries among children who participated in a 1996 clinical trial of the Trovan antibiotic.
The study was conducted on about 200 children altogether and took place during a meningitis epidemic that killed 12,000 children, but Nigerians claim Pfizer didn’t obtain proper regulatory approval for the trial and misled parents. 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, far less than the $9 billion sought by Nigerian officials.
The Supreme Court request comes after Pfizer appealed last July for judicial review of a federal appeals court ruling in January that found the drugmaker can be sued in the US. The attorneys for the Nigerian plaintiffs filed their own Supreme Court brief arguing that Pfizer committed “a gross violation of international legal norms” prohibiting medical experiments without proper consent. (Here is the docket).
A central issue in the case is whether Pfizer followed international law and properly offered informed consent, which is an ongoing flashpoint in the debate over the ethics of conducting clinical trials overseas. In arguing they should be allowed to sue Pfizer in the US, the Nigerian families cited the Nuremberg Code and the World Medical Association’s Declaration of Helsinki, both of which require voluntary consent from participants in medical testing.
harry
extremely important case and will give an indication of current administration’s views on pharma/corporations international obligations.