Zofran is an anti-nausea medication, approved to treat patients undergoing chemotherapy. Although it was not approved for use in pregnant women, it has been prescribed off label to treat morning sickness in pregnant women. Doctors are free to prescribe medications off label, but drug companies can’t market their drugs for unapproved uses, which the Department of Justice alleged in a 2012 lawsuit GlaxoSmithKline did.
Back then, GlaxoSmithKline paid $3 billion in fines for illegally promoting multiple medications, including Zofran, for off-label uses. The drugmaker stated at the time that the lawsuit was settled to avoid the expense of litigation.
The number of Zofran lawsuits filed against GlaxoSmithKline continues to grow, with 238 sitting in MDL 2657 (In Re: Zofran (Ondansetron) Products Liability Litigation) as of March 15, 2016. That’s up slightly from the 223 lawsuits consolidated in the MDL as of February 15, 2016.
GlaxoSmithKline had filed a motion to dismiss the lawsuits, but in January, Judge F. Dennis Saylor denied the motion, finding that the families needed a chance to develop their case. Glaxo’s motion to dismiss was based on federal preemption claims, but Judge Saylor noted that for that claim to be successful, the court must find there is clear evidence that at the time the plaintiff was injured the FDA would have rejected a proposal to change a drug’s label to strengthen the warnings about that particular injury.
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“Without commenting on the merits, plaintiffs are entitled to an opportunity to develop the record as to how the FDA would have responded to a proposal had GSK submitted one,” Judge Saylor wrote.
Plaintiffs in the Zofran lawsuits allege Zofran was unsafe for pregnant women to use because it could cause birth defects in children whose mothers used the medication while pregnant. They further allege that GlaxoSmithKline failed to adequately warn about the risks associated with the drug.
Among injuries allegedly suffered by children exposed to Zofran prior to birth are cardiac malformation (including congenital heart defects), low birth weight, kidney defects and cleft palate.