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Pharmaceuticals / Regulatory Affairs

GSK Prevails as SCOTUS Upholds Dismissal of Paxil Suicide Case

June 7, 2019
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A lower court’s dismissal of a case involving a patient’s suicide while taking generic versions of GlaxoSmithKline’s antidepressant Paxil (paroxetine) will stand, the Supreme Court has ruled.

The Supreme Court said it would not review the 7th U.S. Circuit Court of Appeals’ prior decision to dismiss the lawsuit, handing GSK victory in the lengthy litigation.

In April 2017, the Northern District of Illinois ordered GSK to give $3 million to the widow of Stuart Dolin, an attorney who committed suicide after taking a Paxil generic, but the circuit court of appeals overturned the ruling, finding the drugmaker wasn’t liable.

The appeals court ruled for dismissal in August 2018, saying that after the FDA “effectively told [GSK] to remove the paroxetine-specific warning,” the pharma giant had made four requests to get the agency to update the labeling to reflect adult suicide risks. The drugmaker wasn’t responsible for the incident, the court said, because the agency ordered GSK to keep the warning off the label each time.

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