A trial involving a Chicago lawyer who committed suicide while on a generic version of Paxil will soon be taking place in the US District Court for the Northern District of Illinois in Chicago. At the time of his death, the deceased Stewart Dolin, was on the generic paroxetine, which is manufactured by Mylan.  It’s brand name equivalent is Paxil, an antidepressant developed by GlaxoSmithKline (GSK).

Court documents show that in July of 2010, Stewart Dolin, an attorney and co-chair at Reed Smith LLP in Chicago, took his own life by stepping in front of a train. At the time, he was taking the prescribed paroxetine, a generic antidepressant equivalent to the brand-name Paxil. While the court documents describe Dolin and his family had a good family life with no financial stress,  GSK says Dolin had pressure at work and feelings that led him to seek help from a doctor who prescribed the drug.  Further the complaint alleges that the suicide risk for adults was not adequate on the warning label.  Dolin’s attorney represents that GSK was aware of the suicide risks in adults, but the warning label only contained an increase risk of suicide thoughts and tendencies in Paxil and paroxetine users under 24 years of age.  The warning label on the drug taken by Dolin contained the same language on the label first developed and applied to Paxil.  The widow maintains that the label was misleading to her husband’s doctor in prescribing paroxetine, and he never would have done so if the label was complete with potential side effects.

GSK has noted that the FDA approved the label and in fact expressly refused to add language noting the increased suicide behavior in patients treated with paroxetine. Per GSK, the FDA said it wished to keep language consistent on all similar antidepressants. However twice the US District Judge James Zagel refused GSK’s request for summary judgement but has dismissed Mylan from the action. The judge noted that in the FDA’s response, the agency asked GSK to “please submit a formal meeting request” if GSK “would like to discuss this matter further.” However GSK never followed up. The judge said he believes the question of “the adequacy of Paxil’s 2010 label”would best be decided by “expert testimony and the underlying statistical evidence.”

It is anticipated that this case will be closely watched as the legal limits of liability are tested as they are imposed on a brand-name drug maker for the effects of a generic made by another company.