U.S. District Judge James B. Zagel declined motions for a summary judgment by the defendant and ruled that a lawsuit blaming drugmaker GlaxoSmithKline (GSK) of manipulating data linking its antidepressant Paxil to suicide should move straight to trial.
The lawsuit was filed by Wendy Dolin, widow of Reed Smith LLP attorney Stewart Dolin, who committed suicide shortly after beginning treatment with Mylan Inc.’s generic version of Paxil, known chemically as paroxetine. Mylan is also named in the lawsuit.
Dolin claims that GSK attempted to downplay the risks of Paxil in one clinical trial by increasing the number of suicide attempts in the group being treated with a placebo, and decreasing the number of suicide attempts among the group taking Paxil. The lawsuit also alleges that GSK failed to adequately warn doctors or patients of the suicide risk on Paxil’s safety label.
GSK attorneys filed two motions for summary judgment, arguing that it could not have added suicide risk to the drug’s warning labels without violating federal food and drug laws. The company also argued that Dolin cannot claim her deceased husband’s doctor was not aware of the risk of suicide with Paxil because the doctor had testified to knowing the risk before prescribing the drug.
Dolin’s attorney’s had fought back, arguing that the FDA had called GSK out for mislabeling study subjects’ suicide attempts as “emotional liability” even before the drug was approved.
The trial is expected to begin in September.
Paxil is in a class of antidepressants known as selective serotonin reuptake inhibitors, or SSRIs. It was approved in 1992 to treat major depression and other psychological disorders including panic disorder, obsessive-compulsive disorder, social anxiety, generalized anxiety disorder and posttraumatic stress syndrome. In 2004, the FDA required manufacturers of all SSRIs to add black box warnings to the safety labels stating that the drugs increased the risk of suicidal thinking and behavior in children, adolescents and young adults.