As reported yesterday by Laurence Banville in his Legal Herald article there are now approximately 20 lawsuits filed in the United States against GlaxoSmithKline alleging that Zofran, a drug taken by women during the first trimester to combat morning sickness, caused child birth defects. In this first article of a four-part series I will analyze each of the first five lawsuits with a brief summary on the child birth defects allegedly caused by Zofran (Ondansetron), and the fact patterns of each case.
In the event you have not seen anything about this litigation to date, here is a brief summary. Zofran (Ondansetron) was FDA approved for use in battling extreme nausea in cancer patients receiving chemo and radiation therapy. It was introduced in the US in 1991. The drug was promoted off-label to pregnant women suffering from morning sickness and hyperemesis gravidarum. The drug acts as a blocker of a bodily chemical, seratonin, which triggers the gag reflex. As early as the mid 90’s reports of adverse events were reported to the FDA and by the mid to late 2000’s there were over 200 known birth defects reported to the FDA. For a great summary of all adverse events see: “Zofran: Adverse Event Reports Of Birth Defects & Adverse Fetal Outcomes” by Monheit Law.
1. February 2015 – Case 1:15-CV-10429
This first lawsuit was filed in federal court in Massachusetts by a parent who gave birth to a girl born with an atrial septal defect (ASD), commonly known as a hole in the heart. The complaint alleged that prenatal exposure to Zofran caused the defects and GSK’s failure to warn of these risks was one of the basis for the lawsuit. This lawsuit also listed other birth defects that the plaintiffs allege were caused by ingestion of Zofran, namely: right ventricular hypertension, aortic arch hypoplasia, and facial dysmorphia.
2. February 2015 – Case 2:15-CV-00709
This second lawsuit was filed by a parent from Minnesota. In this case, the plaintiff delivered two children who were born with congenital birth defects. Specifically the plaintiff alleged that child B.F.’s septal defect, and child T.F.’s congenital heart defect were caused by the ingestion of Zofran for morning sickness.
3. March 2015 – Case CGC-15-544524
This lawsuit is the first state court filed Zofran lawsuit where a parent from California alleged that GSK’s drug, Zofran, was the cause of B.G.’s bicuspid aortic stenosis congenital heart defect. Like all other complaints, the plaintiff here stated that had they known the risks, they would not have taken the drug.
4. March 2015 – Case R615761042
This fourth lawsuit in the Zofran litigation was also filed in state court in California. In this specific case, the plaintiff’s son was diagnosed at birth with supraventricular tachycardia or SVT. This condition lead to issues of shortness of breath, rapid breathing and shallow breathing.
5. April 2015 – Case 1:15-CV-00026
The fifth lawsuit, which was filed in federal court in Billings, Montana was filed by the parents of a child, M.M., who was born diagnosed with a cleft palate. This is the first cleft palate birth defect case filed in the Zofran litigation. Of note, the complaint outlined that M.M. endured 10 surgeries in the first 16 years of her life.
So there are the first five lawsuits filed against GSK alleging Zofran caused congenital birth defects. The next part in the series will come soon and will be linked below.
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