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March 13, 2020

Seventh Circuit Reaffirms Decision Involving Inadequate Drug Label

On March 6, the U.S. Court of Appeals for the Seventh Circuit upheld a district court's decision, declining to reopen an inadequate labeling case involving GlaxoSmithKline’s (“GSK”) antidepressant drug, Paxil. A widow of a patient who died by suicide a few days after he had started taking a generic version of Paxil first sued the pharmaceutical manufacturer in 2012, arguing GSK was responsible for the content of the labeling for Paxil and that GSK had negligently omitted the risk for suicide on the drug label. The plaintiff won a $3 million jury verdict in district court.

The Seventh Circuit reversed the district court in 2018, finding that federal law preempted the state law claim of inadequate labeling. The Court found that the FDA had rejected GSK's proposal to add a warning about the risk of suicide to the antidepressant four times, and GSK was not able to change the label unilaterally. Under controlling precedent, state-law claims based on labeling deficiencies are not preempted if the manufacturer could have added the warning on its own.

In the instant case, the widow argued that the $3 million verdict should be restored in light of the Supreme Court’s 2019 decision in Merck Sharp & Dohme Corp. v. Albrecht, a case in which the Supreme Court clarified the standard drug companies must meet in fail-to-warn cases. However, the Seventh Circuit held that it would have come to the same conclusion as it did in the 2018. "In short, Albrecht provided important guidance but did not break new ground that would change the result in this case," the Court said.