U.S. District Judge F. Dennis Saylor IV said, “No!” to GlaxoSmithKline PLC’s latest move in the MDL the Big Pharma giant is in over its anti-nausea drug, Zofran. The plaintiffs claim that the “off-label” use of the drug for morning sickness caused birth defects. The GSK motion to dismiss in Zofran MDL denied.
U.S. District Judge F. Dennis Saylor IV said, “No!” to GlaxoSmithKline PLC’s latest move in the MDL the Big Pharma giant is in over its anti-nausea drug, Zofran. The plaintiffs claim that the “off-label” use of the drug for morning sickness caused birth defects. The GSK motion to dismiss in Zofran MDL denied.
The MDL, based in Massachusetts federal court, is comprise of over 160 cases. The injuries plaintiffs allege were caused by Zofran include congenital heart defects, respiratory defects, kidney defects, clubfoot and cleft lip & palate. GSK moved to dismiss the cases on the grounds that federal law preempts plaintiffs’ state law claims, as held in the SCOTUS’ ruling in Wyeth v. Levine.
Judge Saylor was not convinced. He believed the motion to dismiss came too soon in that the plaintiffs hadn’t had the opportunity to develop facts in the MDL. Those facts, typically found during discovery, make all the difference. This is especially true if, as the plaintiffs state, their belief that GSK has evidence of the link between Zofran use in pregnant women and birth defects.
The plaintiffs contend that GSK has sole control over this information due to the fact that the company didn’t share it with the FDA. The agency never approved Zofran for the treatment of morning sickness. The evidence, according to plaintiffs, includes several animal studies proving the causal connection. GSK conducted the studies in Japan following Zofran’s introduction into the U.S. market. One of these animal studies allegedly shows the same heart defect claimed in many of the suits in the MDL.
The judge applied a three-part analysis of the standard for federal preemption in tackling the question of whether GSK could show “clear evidence” that the FDA would have rejected a Zofran label change if the drug maker increased the warnings. GSK claims that by rejecting a citizen petition asking the agency to reclassify Zofran’s pregnancy risk, the FDA made clear its decision about proposed label changes.
According to Judge Saylor, “In effect, GSK argues that the court need not consider evidence of how the FDA might have answered a change request, because the petition response itself contains the actual answer. GSK’s position, however, is problematic for at least three reasons.”
First, “the court is reluctant to issue a ruling on a motion to dismiss without giving the plaintiffs some opportunity to develop the facts, whatever those facts may be.”
Second, GSK’s motion rests on a potentially material “mischaracterization” of the Levine inquiry, according to Judge Saylor. “GSK frames the question as whether the FDA ‘would not have approved’ the warning that plaintiffs allege state law required.” This doesn’t take into consideration the mechanism of label change requests. Judge Saylor said GSK’s position is that a citizen petition requesting a change is no different than a change request initiated by GSK itself under “change being effected” regulations.
He continued, “If — as plaintiffs allege — GSK was in exclusive possession of information not previously submitted to the FDA indicating the need for a new or strengthened warning, that information would presumably be included in a [change being effected] request. That information could not, however, have been submitted by a citizen petition, as no citizen (according to plaintiffs) had access to it.”
Lastly, the judge said it was currently unclear that the warnings the FDA rejected in the citizen petition are similar to those plaintiffs claim GSK should have given in the first place. This further supports the need for plaintiffs to be allowed time to build their case.
In a separate order, Judge Saylor eased filing burdens for future injured plaintiffs in the MDL. Typically, plaintiffs must file in federal court in their home states; only then can their cases be transferred to the MDL. However, the judge’s order allows Zofran plaintiffs to file directly on the MDL docket, which makes it much easier for future plaintiffs.
The case is In Re: Zofran (Ondansetron) Products Liability Litigation, case number 1:15-md-02657, in the U.S. District Court for the District of Massachusetts.
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