The United States Court of Appeals for the Seventh Circuit (“Federal Appellate Court”) overturned a $3 million Illinois state verdict against GlaxoSmithKline LLC (“GSK”), which marketed paroxetine under the Paxil brand name in the United States using the FDA‐approved label through 2014.
From 1992 to 2014, when GSK sold the right to distribute brand‐name Paxil, GSK was responsible for the “accuracy and adequacy” of the drug’s label. To change the label, GSK needed either FDA permission or newly acquired information that supported a strengthened warning under the CBE regulation (The CBE regulation (“changes being effected”) is an exception to the general rule that changes require advance FDA permission. It allows manufacturers to change a label to “reflect newly acquired information” if the changes “add or strengthen a … warning” for which there is “evidence of a causal association … .” 21 C.F.R. § 314.70(c)(6)(iii)(A)).
Paroxetine is a selective serotonin reuptake inhibitor, one of a class of antidepressants commonly called SSRIs. For decades, the FDA has scrutinized data on the relationship between SSRIs and suicidal behavior.
The plaintiff alleged that in 2010, a doctor prescribed Paxil, the brand‐name version of paroxetine, to treat the plaintiff’s husband’s depression and anxiety. But his prescription was filled with generic paroxetine manufactured by another company. Six days later, the plaintiff’s husband committed suicide. Blood tests showed that paroxetine was in his system. He was 57 years old.
The plaintiff sued GSK, alleging that GSK negligently failed to include warnings that paroxetine was associated with suicide in patients older than 24. Since federal law makes it virtually impossible to sue generic drug manufacturers on a state‐law theory for failure to warn, the plaintiff sued the brand‐name manufacturer, who has more control over drug labels, for injuries caused by taking the generic drugs.
The jury awarded the plaintiff $3 million for the death of her husband, and GSK appealed.
Federal Appellate Court Opinion
Brand‐name and generic drug manufacturers have different federal drug labeling duties. A brand‐name manufacturer seeking new drug approval is responsible for the accuracy and adequacy of its label. 21 U.S.C. § 355(b)(1), (d). A manufacturer seeking generic drug approval, on the other hand, is responsible for ensuring that its warning label is the same as the brand name’s. 21 U.S.C. §§ 355(j)(2)(A)(v) & (j)(4)(G); 21 C.F.R. §§ 314.94(a)(8) & 314.127(a)(7). Thus, from 1992 to 2014, when GSK sold the right to distribute brand‐name Paxil, GSK was responsible for the “accuracy and adequacy” of the drug’s label. To change the label, GSK needed either FDA permission or newly acquired information that supported a strengthened warning under the CBE regulation.
The Federal Appellate Court held in its opinion filed on Augst 22, 2018: “GSK asked the FDA for permission to modify the paroxetine label as plaintiff argues was needed. The FDA said no, repeatedly. Federal law thus preempted plaintiff’s Illinois‐law claim that GSK should have warned of a risk of adult suicidality on the paroxetine label in 2010. GSK added a similar warning in 2006, and the FDA ordered that GSK remove that label and replace it with a class‐wide SSRI warning in 2007. As a matter of law, this is what Levine called “clear evidence” that the FDA would have rejected the warning that plaintiff seeks under Illinois law. After 2007, GSK lacked newly acquired information that would have allowed it to add an adult‐suicidality warning under the CBE regulation.”
Source Dolin v. GlaxoSmithKline LLC, No. 17‐3030.
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