Will a recent court ruling move Pfizer closer to settling $9 billion in claims stemming from its controversial Trovan clinical trial in Nigeria?
Last month, a federal appeals panel jolted the drugmaker by deciding that dozens of Nigerians can pursue lawsuits in a U.S. court over its 1996 clinical trial for the Trovan antibiotic. You may recall the study, which was conducted on approximately 200 children amid an outbreak of meningitis, was blamed for the deaths of 11 youngsters and left many others blind, deaf, paralyzed or brain-damaged.
Beyond the immediate effect on the litigation, though, the U.S. Court of Appeals for the Second Circuit also put the entire pharmaceutical industry on notice. That's because 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. With drugmakers increasingly sponsoring clinical trials around the world, the ruling is a harsh reminder that the risks - in terms of liability and negative publicity - can be substantial if something goes awry.
"This is actually of huge importance to all American industries, not just pharmaceutical companies," says Mark Herrmann, an attorney at the Jones Day law firm, who regularly defends drugmakers in product-liability litigation. "Under the law of nations, [the plaintiff] can score big, depending upon whatever happens in another country and whether they [the plaintiff] can hold the company accountable and if there was government involvement...Once you've changed forums, it creates a whole lot of uncertainty for companies...And as more trials are done overseas, [drugmakers] have to be real careful about how they conduct them."
Pfizer has repeatedly maintained that it did nothing improper and that any deaths or injuries were due to the 1996 meningitis epidemic, not treatment given patients in the study.
In arguing they should be allowed to sue Pfizer in the U.S., the Nigerian families cited the Alien Tort Statute, which allows U.S. courts to hear human rights cases brought by foreign citizens, including cases against American officials and corporations. The statute also makes it possible for foreign citizens to press their case when they are unable, otherwise, to obtain justice in their own country. To make their point, the families allege the Nigerian government was involved in "all stages" of the trial.
"This sends a signal to the pharmaceutical industry that, if you don't do informed consent, it's a violation of international law," says Peter Safirstein, an attorney at Milberg Weiss Bershad & Schulman, who represents some of the Nigerians. "And the ruling has far-reaching implications - the stakes are higher now, because pharmaceutical companies are being cautioned to act very carefully when testing on humans. They must know those tests are going to be scrutinized very carefully."
In a Feb. 13 petition requesting that all 12 active judges of the Second Circuit Appeals Court review the Jan. 30 decision, Pfizer acknowledged the seriousness of the situation. The earlier ruling "has grave and far-reaching consequences for U.S. companies doing business abroad...(and) creates an unprecedented private right of action under international law in the U.S. courts," wrote Pfizer's attorneys at the Kaye Scholer law firm in New York.
A review may not occur if a settlement is reached, of course. But one expert cautions that the appeals court ruling, nonetheless, highlights the growing difficulties of conducting clinical trial overseas.
"Whenever there's an increase in litigation and settlement dollars, and any liberal interpretation toward a claimant, it can make things problematic for sponsors trying to get things off the ground," says Catherine Mulligan, an assistant vice president at William Gallagher Associates, an insurance brokerage that underwrites clinical trials for the pharmaceutical industry. "Something like this can change the terms and conditions of the available coverage and what insurers provide."
image by flickr user Joe Gratz used under a creative commons license.