June 13, 2014 — The Wall Street Journal reports that a lawsuit has been filed by the widow of a man who took six pills of generic Paxil (paroxetine) and committed suicide.
The plaintiff, Wendy Dolin, alleges that Paxil caused her husband to commit suicide in 2010. In 2012, she filed a lawsuit in federal court in Chicago. She accuses GlaxoSmithKline of negligence for failing to warn that Paxil could increase the risk of suicidal behavior for adults. Paxil and other antidepressants have carried a Black Box Warning about suicidal behavior in children and adolescents, but not adults.
Normally, “failure to warn” lawsuits involving generic drugs are dismissed. Over the last three years, the Supreme Court has ruled that generic drug-makers are not liable because they must include the exact same warning label as the brand-name drug.
In an unusual twist, an appeals coud ruled against GlaxoSmithKline’s bid to dismiss the lawsuit. According to the decision (PDF) from U.S. District Court Judge James Zagel:
“That GSK did not manufacture the pill Mr. Dolin ingested is largely immaterial on this point. A problem with paroxetine’s warning label and design will impact the name-brand version of the drug manufactured by GSK and any generic versions of the drug equally. The same “fix” will be required.”