Dolin v. GlaxoSmithKline LLC

Dist. Ct. erred in denying defendant’s request to dismiss on preemption grounds plaintiff’s state-court action, alleging that defendant-manufacturer of Paxil (brand-name version of paroxetine) was negligent in failing to warn in said drug’s label that there was association between use of said drug and suicide in older adults. Record showed that in 2007, FDA had approved language in instant label that use of said drug had association with suicide in individuals under age 24, and that FDA had repeatedly denied defendant’s request to change label to include similar warning for older adults. As such, federal law preempted instant state-law claim that defendant should have included warning of suicide for older adults under these circumstances. Moreover, plaintiff failed to show that defendant had acquired new evidence demonstrating suicide risk for older adults subsequent to 2007 FDA directive to defendant and others to use language in subject label that is at issue in instant lawsuit, so as to allow defendant to include adult suicide warning in label under CBE regulations.