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Oregon Mother Claims Zofran Caused Baby’s Cleft Palate

pregnant woman wearing white in profileAn increasing number of lawsuits involving Zofran-related birth defects have been filed across the nation. One of the latest claims was brought by an Oregon mother who argues that her child’s cleft palate and laryngeal cleft are a direct result of the anti-nausea drug she took while pregnant. GlaxoSmithKline LLC is named defendant in the suit, and is charged with marketing Zofran for off-label purposes without sufficient testing.

Ondansetron has been prescribed for years as an effective morning sickness treatment, but the medication’s only approved purpose is to ameliorate nausea in chemotherapy and post-operative patients. The lawsuit contends that GSK’s marketing materials to Ob/Gyn practitioners stressed Zofran’s “Pregnancy Category B” label, thus creating a false impression that the safety of Zofran during pregnancy had been established.

The Oregon mother argues that GSK did not adequately test Zofran’s effects in utero to support promoting it for use in pregnant women.

Child born with laryngeal cleft

During her first trimester of pregnancy, the plaintiff was prescribed Zofran to help mitigate her morning sickness symptoms. In 2012, she gave birth to her child who was diagnosed with severe congenital malformations, including a laryngeal cleft. This birth defect is characterized by an abnormal opening between the esophagus and the larynx, in which liquid and food are at risk of seeping into the lungs. In more serious cases, immediate surgical intervention is required to close the opening in the larynx.

Children with this malformation and/or a cleft palate often suffer from eating and breathing problems and are at higher risk for infections. Besides surgery, treatments may entail speech therapy, specialized dental care, and prosthetics.

According to the suit, the plaintiff underwent extensive testing which failed to identify genetic anomalies that might explain her child’s deformities. The family has no history of cleft palate or birth defects, and the claimant was unaware of the dangers posed to her unborn child when she began taking Zofran early in her pregnancy.

Her allegations mirror those leveled in dozens of other lawsuits filed against GSK, which seek to hold the pharmaceutical giant liable for mental anguish, diminished enjoyment of life, physical suffering, medical expenses and other non-economic losses. The civil action will be joined under multidistrict litigation #2657 underway in Massachusetts federal court.

Failure to warn of birth defect risks

The Zofran lawsuit lists several causes of action including fraudulent concealment, negligence, strict products liability and negligent misrepresentation. To this day, GSK has yet to submit data to the FDA that demonstrates the safety or efficacy of Zofran in pregnant women, states the suit.

Instead, GSK has engaged in “off-label” promotion despite having received reports of birth defects associated with prenatal exposure to the drug. The Delaware-based drug maker has received at least 200 reports of congenital malformations linked to Zofran, according to court papers, but has failed to put a black box warning on the label to announce this risk.

Since 1992, the defendant has purportedly been made aware of congenital defects and adverse outcomes arising from Zofran use during pregnancy including:

  • Heart defects
  • Orofacial defects
  • Kidney malformations
  • Intrauterine death
  • Stillbirth
  • Death in utero
  • Musculoskeletal anomalies

Despite rising litigation concerning Zofran pregnancy risks, GSK continues to defend the safety of its product.

  1. Children’s Hospital, Laryngeal Cleft in Children
  2. U.S. Food and Drug Administration, Ondansetron (marketed as Zofran) Information,