- GlaxoSmithKline (GSK) faces a September trial over charges a generic version of the drugmaker's antidepressant Paxil led to an adult man's suicide. The charges claim GSK failed to warn about Paxil's, and relatedly, its generic version's side effects.
- The drugmaker had sought a summary judgment, but a U.S. District Judge for the Northern District of Illinois declined to rule. This is GSK's first lawsuit over the suicide of an adult using Paxil, although the company has faced previous claims related to suicidal thoughts in teens taking Paxil.
- The drug at the heart of this case is a generic formulation of paroxetine manufactured by Mylan.
A 2013 Supreme Court ruling determined generic drugmakers cannot be held liable in state court for their drugs' side effects. According to the court, the FDA's approval of generic products preempts state law. Therefore, GSK may be held responsible for the death of Stewart Dolin, whose wife, Wendy Dolin, is bringing the case to court.
The presiding judge for this case, U.S. District Judge James Zagel, already dismissed Dolin's initial suit against Mylan because of the Supreme Court ruling.
The label for Paxil does warn about the risk of suicidal thoughts in adolescents and teenagers, but not adults. GSK argues it should not have responsibility for suicidal thoughts in adults older than 24, because the FDA did not require that as part of the label.