A federal court will select jurors to decide whether GlaxoSmithKline should be held responsible for a suicide committed after taking a generic version of Paxil, which was manufactured by Mylan.
The widow of the lawyer who committed suicide claims the drug's warning label did not contain enough information on suicide risk. After taking paroxetine, attorney Stewart Dolin stepped in front of a train in 2010. The warning label on Mylan's generic paroxetine contained the same language as the label developed by GSK for Paxil.
The warning label noted an increased risk of suicidal thoughts and tendencies in Paxil and paroxetine only in users under the age of 24. GSK says that the FDA refused the drugmaker's request to add language noting the increase in suicidal behavior to the approved warning label, becaue the agency wanted to keep language consistent on all similar antidepressants.
The trial will be important in terms of testing the legal limits of liability that can be imposed on a brand drugmaker for the effects of a generic equivalent owned by another drugmaker.
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