GlaxoSmithKline ($GSK) will have to go to court to fight claims that a generic version of its Paxil antidepressant triggered an Illinois man's suicide. U.S. District Judge James Zagel declined to rule on the drugmaker's motions for summary judgment, setting the case up for trial in September.
The trial would be GSK's first over suicide claims in an adult. The drugmaker has faced previous lawsuits over suicidal thoughts in teens using Paxil (paroxetine hydrochloride), with many claims raising questions about a controversial trial, dubbed Study 329. A warning about suicide risks in children and young people was added to Paxil's label in 2004.
The plaintiff in the Illinois case, Wendy Dolin, accuses GSK of failing to warn doctors and the public about Paxil's side effects, and, by extension, Paxil generics. Her late husband, Stewart Dolin, killed himself while taking a generic version of the drug.
The case is one in a series of legal battles against branded drugmakers over injuries allegedly caused by generic versions of their products. Because generics makers have been required by the FDA to duplicate official branded labeling, plaintiffs have attempted to hold branded pharmas responsible.
Plus, patients have been barred from suing generic drugmakers in state courts for damages. In a 2013 Supreme Court ruling, the justices determined that generics makers can't be held liable in state court for their drugs' side effects, because the FDA's approval of their products pre-empts state law.
The Dolin case initially included claims against Mylan ($MYL), which made the generic version in question, but Zagel dismissed that section of the case in 2014, citing federal preemption.
According to The American Lawyer, GSK's motions for summary judgment argued that it shouldn't be liable for any side effects caused by a generic drug and that it shouldn't be guilty of failing to warn about suicide risks in adults older than 24, because the FDA has never required the company to add such a warning to Paxil's official label. Zagel put off deciding on those issues until after the September trial begins.
A new BMJ analysis published last fall, which dug into original data in GSK's controversial "Study 329," found that "a very high rate" of children and teens in the trial became suicidal. Of the 275 kids and adolescents participating, 11 in the Paxil arm developed suicidal or self-harming behavior compared with 1 in the placebo arm.
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