We were greatly disappointed to learn that the United States Court of Appeals for the First Circuit has denied the plaintiffs’ appeal in the Zofran litigation. This ruling upheld the MDL judge’s decision dismissing the cases under the doctrine of “clear evidence preemption.” As a result, after eight years of fighting on behalf of injured children and their families, the Zofran litigation has come to an end.
In order to prevail in a civil claim against the makers of Zofran for causing birth defects, we had to prove that GSK should have warned of the potential risks of Zofran when used during pregnancy. GSK argued that the FDA would not have approved a stronger pregnancy warning.
After Judge Saylor ruled against us, the litigation was appealed to the appellate court, and the preemption issue was presented for briefing and oral argument.
In a 35-page opinion we received this week, the appellate court ruled that our claims were “preempted,” which means there was “clear evidence” that the FDA would have rejected the warning that we allege would have been required. In its analysis, the Court evaluated the opportunities the FDA had to change the label. This included an application in 2020 by Novartis (the drug company that bought the rights to Zofran from GSK in 2015) to the FDA to change the warning label. In a stunning abdication of its responsibility to protect the public from unsafe drugs, the FDA rejected that request.
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Yes, you read that right. The FDA rejected an application by a drug company to include a safety warning. A warning that advised pregnant women not to take the drug during the first trimester. So, their babies would not be at risk of being born with horrific congenital heart and cranial-facial malformations.
Once the FDA rejected Novartis’ application, we knew our case was in grave peril.
We countered that there were additional studies that GSK and Novartis had that they did not produce to the FDA, and that these studies would have compelled the FDA to approve a pregnancy warning. Regrettably, and incorrectly we believe, our argument did not sway the Appellate Court.
So, after nearly eight years of investigation and litigation, our efforts come to a close. Even after 37 years of practicing law on behalf of injured consumers, losing does not get easier. That is especially true here, where we represent terribly maimed children and their families. Certainly, it was not for lack of effort or resources. The Zofran MDL was led by some of the best and most experienced pharmaceutical lawyers in the country – lawyers I would litigate with again any day of the week. At the outset of the case, nobody could have predicted the obstacles put in our way. But our obligation to our clients is to put forward our best effort, and that we did, even though sometimes our best is not enough.