friday, 24 august of 2018


Federal appeals court rules drug company not liable for injuries caused by generic version

The US Court of Appeals for the Seventh Circuit on Wednesday tossed a $3 million verdict against GlaxoSmithKline saying that GSK could not have warned about the risks of suicide on its drug label for Paxil.

GSK is the manufacturer of Paxil, the generic of which is paroxetine, a psychotropic drug often used to treat anxiety and depression. The wife of an attorney filed a lawsuit after her husband committed suicide only six days after filling his prescription of the generic paroxetine. She accused GSK of omitting dangers on the drug’s label, including failure to warn about increased risk of suicide. A jury awarded the wife $3 million and GSK appealed, saying GSK is not liable for the attorney’s death, since he took the generic drug—not Paxil. Further, GSK contended it could not have change the warning label because doing so would have required FDA approval.

The court held that under federal law, GSK could not have warned about the risks of suicide. Because the risk was not included on the 1992 label that the FDA approved, GSK could have added the risk only under one of two circumstances: “GSK needed either FDA permission or newly acquired information that supported a strengthened warning under the [‘changes being effected’] CBE regulation.”

Since increased risk of suicidality in youth and adolescents was already included in warning labels, GSK conducted its own study in 2006 of the the same possible risks in adults. GSK submitted its results to the FDA for approval, but changes its label before the FDA made a determination, arguing it had authority under the CBE regulation. The new label included a warning of increased risk for all adults. Only one month after GSK changed its label and sent notice to doctors and medical providers, the FDA concluded that SSRI antidepressants (such as Paxil) increase suicidality risk in persons under 25, but not those between 25 and 65. As such the FDA required all SSRI manufacturers to warn of persons under 25 and required all labels for SSRIs to be the same. GSK then had to change its label to reflect the same, even though paroxetine showed an increased risk in all adults compared to other SSRIs.

As such, the court said GSK should have been dismissed from the lawsuit since it was federally preempted from changing the warning label to reflect the risk complained of in the lawsuit. Although Illinois law would have permitted GSK to change its label, federal law did not.

To add a warning through the CBE regulation, GSK needed newly acquired information about paroxetine that would allow it to add a warning about suicide risk in adults. And even if GSK had newly acquired information along these lines, GSK can still succeed on its preemption defense if there is clear evidence that the FDA would have rejected the adult‐suicidality warning that plaintiff argues was tortiously omitted.

(Published by Jurist, August 23, 2018)

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