Issue Date: March 3, 2008
Justices Mull Limits On Liability Lawsuits
The Supreme Court is considering whether pharmaceutical companies should be shielded from product liability lawsuits unless the firms misled FDA to get their drugs approved. At issue is whether that fraud exception, which allows lawsuits to proceed, is preempted by federal regulation of pharmaceuticals. The dispute stems from several suits filed against Warner-Lambert, now owned by Pfizer, over its diabetes drug Rezulin. A group of 27 Michigan plaintiffs, including relatives of six Rezulin patients who died from liver damage, sued Warner-Lambert after FDA ordered Rezulin to be taken off the market in 2000. The drug has been linked to nearly 400 deaths. During arguments before the high court on Feb. 25, several justices, including Stephen G. Breyer, questioned the wisdom of allowing juries to decide whether FDA has properly evaluated a drug's risks versus its potential life-saving benefits. "Who would you rather have make the decision as to whether this drug is, on balance, going to save people or, on balance, going to hurt people?" Breyer asked. "An expert agency on the one hand or 12 people pulled randomly from a jury pool who see before them only the people whom the drug hurt and don't see those who need the drug to cure them?" A decision in the case, Warner-Lambert v. Kent, is expected by July.
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