Amid increased warnings that the anti-nausea drug Zofran may be linked to serious birth defects when used during pregnancy, a federal panel last year created a special multidistrict litigation docket for victims to use as an avenue for compensation from the drug’s maker, GlaxoSmithKline (GSK).
With hundreds of lawsuits already filed, GSK filed a request last month to have the lawsuits against it thrown out of court before families even had a chance to prove their case. The federal judge overseeing the Zofran birth defect lawsuits denied GSK’s attempts to keep the cases out of court as premature at best.
GSK had argued the families’ state law claims were preempted by federal law under the U.S. Supreme Court decision in Wyeth v. Levine, which held that federal regulatory clearance of a medication does not shield the manufacturer from liability under state law. U.S. District Judge F. Dennis Saylor IV said that he was "loath to dismiss" the claims without giving the families the chance to develop the facts of their respective cases through discovery.
Zofran, manufactured by GlaxoSmithKline and first approved by the FDA in 1991, is intended for extreme cases of nausea, such as with cancer medications or following surgery. It was not FDA-approved for use during pregnancy. However, it has increasingly been prescribed to expectant mothers for morning sickness since its initial approval. GSK was fined a record $3 billion in 2012 by the federal government for illegally promoting Zofran for such unapproved purposes. GSK earned more than $1.5 billion per year in sales, and it is evident the $3 billion fine had little overall impact on the pharmaceutical giant.
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The families affected by Zofran usage argued on January 6 that because the FDA hasn’t approved Zofran to treat morning sickness, only GSK has control over the relevant evidence of the foreseeable risks of using Zofran while pregnant.
In its January motion to dismiss, GSK argued that the FDA’s negative response to a citizen petition requesting that the agency reclassify the pregnancy risk for Zofran demonstrates the FDA had already made a decision about the validity of the Zofran warnings. Judge Saylor disagreed, stating,
“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 . . .”
In short, the standard of “clear evidence” involves a fact-based evaluation, so Judge Saylor felt the court should not rule on a motion to dismiss “without giving the plaintiffs some opportunity to develop the facts, whatever those facts may be.”
“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,” Judge Saylor said. “That information could not, however, have been submitted by a citizen petition, as no citizen (according to plaintiffs) had access to it."
Hundreds of families have joined the multidistrict litigation against GSK, and now they all will have the opportunity to proceed with their claims.
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.
