Federal appeals court rules in favor of drugmakers in drug-label preemption case

[Source: Health and Life Sciences Law Daily, April 9, 2008 - AHLA]

The Legal Intelligencer (4/9, Duffy) reports that in a 2-to-1 decision (pdf) issued Tuesday, the 3rd U.S. Circuit Court of Appeals in Philadelphia, Pa., "ruled that the makers of Paxil (paroxetine) and Zoloft (sertraline) cannot be sued for failing to warn of a risk of suicide because the Food & Drug Administration (FDA) has explicitly refused to order such warnings." In the opinion, Judge Dolores K. Sloviter, writing for the majority, "said the FDA has 'actively monitored' the possible risk of suicide from taking the class of antidepressant drugs known as selective serotonin re-uptake inhibitors, or SSRIs, for two decades, and concluded that the suicide warnings demanded by plaintiffs 'are without scientific basis and would therefore be false and misleading.'"

"While narrowly written, the decision was a clear victory for drugmakers and Bush administration officials," who argue that scientists at the FDA, "not lay juries," should decide drug-labels information, the Philadelphia Inquirer (4/9, Stark) adds. However, "[l]awyers for the plaintiffs countered that the FDA was outgunned and poorly funded at best and that lawsuits represented an important check on the system and a last attempt for injured victims to get redress." Writing in dissent, "Judge Thomas L. Ambro argued that for 75 years, the FDA has viewed state suits 'as complementary to its warning regulations. Only for the last two years has it claimed otherwise.'" The Inquirer notes that the "issue could come to a head in October, when the U.S. Supreme Court is scheduled to hear Wyeth v. Levine, another dispute over the adequacy of a drug label." Some legal experts say the "case could determine the scope of future pharmaceutical litigation unless Congress intervened."