After Wendy Dolin’s husband, Stewart, committed suicide while taking a generic version of GlaxoSmithKline’s antidepressant Paxil, the grieving widow sued the drug’s inventor—one of many legal challenges filed against a branded drugmaker over injuries allegedly caused by a generic copy. Now, more than two years after GSK was forced to go to court to fight the claim, the company has prevailed.
The 7th U.S. Circuit Court of Appeals dismissed the case Wednesday and reversed a 2017 jury verdict awarding $3 million to Dolin. Their argument, in short, was that federal law prevented GSK from adding a warning to Paxil’s label about a link between the drug and suicide in adults. Because generic drugmakers are required to copy branded labels, the version that Dolin’s husband took also lacked the warning. But GSK is not liable for that, the appeals court ruled.
Stuart Dolin was prescribed generic Paxil in 2010 to treat depression and anxiety. Six days later, the 57-year-old committed suicide and the drug was found in his blood, according to court documents. At the time, the labels on both the branded and generic versions of Paxil only warned of a suicide risk in people under the age of 24—a flaw that GSK should have been held responsible for, Dolin’s attorneys argued.
Last April, a jury for a U.S. district court in Illinois sided with Dolin, awarding her $3 million of the $39 million her lawyers initially sought. GSK appealed, arguing that the FDA had rejected earlier attempts to extend the suicide risk warning on Paxil’s label, and that federal law would preempt any state laws requiring such a warning. The appeals court agreed.
“We are pleased the Court reversed the decision in this case,” a spokeswoman for GSK said in an email to FiercePharma. “Mr. Dolin’s suicide was a terrible tragedy, but there is no viable cause of action against GSK.”
An attorney for Dolin did not immediately respond to a request for comment.
In 2011, the U.S. Supreme Court ruled that generic drugmakers cannot be sued over a failure to warn about side effects. That decision sparked a rash of lawsuits against manufacturers of branded drugs—the results of which have been mixed.
In March of this year, the Massachusetts Supreme Judicial Court ruled that Merck and other branded drugmakers could be sued for recklessness over injuries suffered by patients taking generic versions of their products, if it can be shown that they didn’t adequately update warning labels. The drug at issue in that case was Proscar, used to treat enlarged prostate or, in some men, baldness.
But a couple of months later, the West Virginia Supreme Court ruled that branded drugmakers cannot be found liable for injuries alleged to have been caused by generic copycats. That case revolved around Johnson & Johnson’s antibiotic Levaquin.
In the GSK case, the 25-page ruling dismissing the case portrays a company that seemed to be trying to update Paxil’s label to reflect evidence of a suicide risk in adults. “GSK asked the FDA for permission to modify the [Paxil] label as plaintiff argues was needed,” the ruling says. “The FDA said no, repeatedly.”