Since October 2015, federal Zofran lawsuits have been consolidated in the U.S. District Court for the District of Massachusetts. Just a couple months after consolidation, manufacturer GlaxoSmithKline (GSK) filed a motion to dismiss all of the cases pending in the newly established MDL, “as preempted by federal law.”
Plaintiffs claimed that GSK failed to warn about the serious risks associated with Zofran, including the increased risk of birth defects. According to GSK, however, the FDA would have rejected any warning label update that the plaintiffs assert should have been present in the prescribing material. In support ot its argument, GSK pointed to the fact that the administration had previously rejected a citizen’s petition to change the pregnancy category on the warning label. This change would have indicated that Zofran posed a risk to unborn fetuses.
Because the FDA rejected that update, GSK asserts that they would have rejected any attempt to add warnings concerning pregnancy on the label, as well. For that reason, they asserted that the court should dismiss the cases claiming “failure to warn.” Plaintiffs argued that the motion to dismiss was premature, since discovery had just begun.
U.S. District Judge Dennis Saylor has agreed with the plaintiffs. He recently rejected GSK’s motion, indicating that it’s too early to determine preemption at this point.
FDA’s Response to Citizen’s Petition Proves Adequacy of Zofran Warnings?
The judge issued his decision in a January 22, 2016 court order. There, he reviewed the background of the issue, including the citizen’s petition submitted in January 2013. That petition asked the FDA to reclassify Zofran (ondansetron) from pregnancy risk category B to a pregnancy risk category C, D, or X, after evaluation of new safety information. Had this petition been approved, the FDA would have required new, stronger language on the Zofran label indicating the risks associated with use by pregnant women.
The FDA rejected the citizen’s petition request in October 2015. It based its decision on a review of the scientific literature and other pertinent data, including adverse event reporting information. The FDA added that though it was denying the request, it would continue to monitor information regarding the use of the drug during pregnancy.
GSK asserts that because the FDA already issued a decision concerning “the adequacy of ondansetron warnings in response to a citizen petition,” that the court need not consider further evidence of how the FDA might have answered a change request, because the petition response contained the actual answer.
Court Rejects GSK’s Motion to Dismiss Zofran Lawsuits
The court rejected GSK’s motion based on the following three issues:
- The court was reluctant to approve a motion to dismiss without giving the plaintiffs some opportunity to develop the facts—to show evidence that the warnings were not adequate.
- GSK’s position is misplaced because it equates a change requested by a citizen petition with one requested by a manufacturer of a drug. There is no “clear evidence” that the FDA would have rejected GSK’s labeling change had they suggested a strengthened warning label. GSK could have had additional information not previously shown to the FDA that would have indicated the need for a stronger warning. The judge concluded that the plaintiffs have a right to develop the record as to how the FDA would have responded to a GSK proposal had the company submitted one.
- It’s still not clear how the warnings plaintiffs allege GSK should have provided compare (or conflict) with the label changes and warnings rejected by the FDA in response to the citizen’s petition. If there is a difference, it may help establish the relative likelihood of the FDA’s approval or rejection of a manufacturer’s submission for change.
In summary, the Court asserted that GSK’s motion to dismiss was “premature at best,” and denied it without prejudice for GSK to renew the motion at a later date.
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