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Lawsuit Attributes Son’s Fatal Heart Defects to Zofran

baby holding mother's fingerA grieving mother has filed a Zofran lawsuit in the U.S. District Court for the Eastern District of Kentucky alleging that her infant son’s fatal birth defects were caused by the anti-nausea drug, which she took while pregnant.

This complaint is among the most recent lodged against pharmaceutical giant GlaxoSmithKline relating to its marketing and manufacturing of a medication that has garnered a growing amount of negative attention due to suspected links to birth defects.

Underlying facts of Zofran lawsuit

In this case, the plaintiff states that she was prescribed anti-nausea drug Zofran during the first trimester of her pregnancy, as a means to ameliorate and prevent debilitating morning sickness symptoms. According to the complaint, the labeling on the generic version of Zofran she received merely stated that the drug ought to be used only when necessary during the course of pregnancy and that patients should discuss risks and benefits with their physicians. There was no mention whatsoever of potential birth defects resulting from its use, despite conflicting studies and reports suggesting that the drug, when taken during pregnancy, increases the risk of skeletal malformations, cleft lip and other anomalies in infants.

The plaintiff delivered a son on April 7, 2012, at which point a medical evaluation revealed that the infant suffered from multiple congenital heart defects including hypoplastic right heart syndrome with right ventricle depending on coronary artery circulation. Eight days after he was born, the baby died from cardiac failure stemming from the heart defects diagnosed at his birth.

An autopsy revealed that while the child was “vigorous” when born, he quickly suffered respiratory distress attributable to his heart defects and died despite the fact that he was given prostaglandins in order to address his condition. According to the plaintiff’s complaint, no family history of heart defects existed that would have explained the infant’s diagnosis.

Multiple causes of action raised against GSK, hospital

The plaintiff has included numerous causes of action in her Zofran complaint, including negligence and wrongful death against the drug maker and the dispensing hospital for failing to ensure that generic bioequivalent drugs are the same as the name-brand drug and that labeling is also the same.

It is also alleged that GSK did not conduct sufficient pre-clinical and clinical testing or post-market surveillance to assess Zofran’s safety when taken by expectant mothers. GSK is also accused of fraudulently minimizing and/or concealing research studies which called into question whether the drug was safe for pregnant women and for aggressively promoting the “off-label” use of Zofran for morning sickness when the drug had been approved by the FDA only as a treatment for nausea and vomiting in chemotherapy and radiation patients.

Damages sought by plaintiff

The claimant argues that had she been properly made aware of the risks of Zofran while pregnant, she would avoided the drug altogether and sought alternative remedies for her morning sickness. Much like other Zofran plaintiffs who have come forward against GSK, the plaintiff in this case is seeking compensatory damages for medical expenses incurred in the treatment of her son, the mental and emotional anguish suffered, the loss of enjoyment and familial relationship resulting from the child’s death, punitive damages against the defendants as well as attorney fees and costs of bringing suit.

  1. Clinical Pharmacology & Therapeutics, Ondansetron Pharmacokinetics in Pregnant Women and Neonates: Towards a New Treatment for Neonatal Abstinence Syndrome,

  2. Clinical Pharmacokinetics, Placental transfer of ondansetron during early human pregnancy,

  3. Toronto Star, Birth defects blamed on unapproved morning sickness treatment,

  4. U.S. Food and Drug Administration, Ondansetron (marketed as Zofran) Information, PatientsandProviders/ucm271924.htm