June 13, 2014 — The widow of a man who committed suicide after taking six doses of generic Paxil (paroxetine), an antidepressant, has filed a lawsuit alleging that drug-makers are not warning that Paxil can increase the risk of suicide for adults.
The lawsuit was filed on behalf of Stewart Dolin, a man from Chicago who committed suicide in 2010. His wife, Wendy Dolin, filed a lawsuit in federal court in Chicago in 2012. She also launched a foundation to educate the public about side effects of antidepressants.
Antidepressants have carried warnings about suicidal behavior in children and adolescents since 2006. Dolin says the warning label on generic Paxil is inadequate because it does not contain warnings about the increased risk of suicidal behavior for adults over the age of 24. She also accuses the manufacturer, GlaxoSmithKline, knew about the risk but failed to warn doctors and consumers.
In the last three years, the Supreme Court ruled that manufacturers of generic drugs cannot be held accountable for failing to warn about side effects. The manufacturers of generic Paxil must include the exact same warning label as the manufacturer of brand-name Paxil.
GlaxoSmithKline asked a judge to dismiss the lawsuit because it involves a generic drug. In an unusual turn of events, an appeals court denied the bid, according to the Wall Street Journal.
According to a 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.”