GlaxoSmithKline Faces Zofran Birth Defect Lawsuits

Pittsburgh, PAGlaxoSmithKline faces more Zofran lawsuits alleging babies developed birth defects after being exposed to Zofran in the womb. While some women say their children have outgrown the Zofran side effects, others say the effects have lasted well into their child's life, and traumatized their families. With lawsuits consolidated for pretrial proceedings, more parents are filing claims against the maker of Zofran, saying they would never have exposed their unborn babies to the drug if they had known about the risks.

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.

In its motion to dismiss, Glaxo pointed to a citizen’s petition requesting updated label changes for Zofran warning of the risk of birth defects. The FDA rejected that proposed label change, which Glaxo argued was a sign the agency would reject any future label changes. But rejecting a petition from a citizen is not the same thing as rejecting a label change requested by a manufacturer, especially if that manufacturer has further evidence that the citizen may not have had. Plaintiffs allege Glaxo had information about the risk of side effects that the FDA did not have access to, which may have affected its decision about the label changes.

“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.