Two additional Zofran (ondansetron) lawsuits were recently transferred to the U.S. District Court of Massachusetts for pre-trial proceedings. Two women, one from Mississippi and one from Texas, similarly allege that the anti-nausea medication caused serious birth defects in their babies.
In one case initially filed in the U.S. District Court for the Southern District of Texas, a mother from Mississippi alleged that prenatal exposure to a generic Zofran led to her baby’s many congenital abnormalities, including at least 13 severe symptoms and fetal birth defects, skeletal muscle atrophy, and cardiomegaly (abnormally enlarged heart).
In the second lawsuit, also originally filed in Texas, a woman who took a generic form of Zofran allegedly led to her unborn child being born with two cardiac septal defects: Atrial septal defect and ventricular septal defect, so-called “hole-in-the-heart” abnormalities. A number of large studies in Europe have tied Zofran to increased risks for these defects and, in one paper, Danish researchers discovered that Zofran’s active ingredient could increase risks for cardiac septal defects by 200-400 percent.
These two recent filings bring the total to nearly 300 lawsuits brought against the maker of Zofran and consolidated in the Boston federal court. Parents in the more than 280 lawsuits organized in U.S. federal court in Boston, also similarly allege in that GlaxoSmithKline opted to market Zofran specifically as a morning sickness treatment, an allegation initially raised by the U.S. Department of Justice (DOJ). In a lawsuit brought over alleged healthcare fraud, the U.S. Federal Government accused GlaxoSmithKline of marketing a variety of drugs, including Zofran, for unapproved (off-label) purposes. Off-label drug promotion is illegal in the United States. GlaxoSmithKline settled with the DOJ for $3 billion, but never admitted to the allegations.
Zofran is manufactured by GlaxoSmithKline and is approved for use in post-operative surgery patients and patients undergoing certain cancer treatments to help fight serious nausea. Zofran is not approved to treat pregnancy-related nausea and vomiting; however, some one million pregnant women are prescribed Zofran, or its generic equivalents, every year for this purpose, according to an analysis published previously in the American Journal of Obstetrics and Gynecology.
Despite that Zofran is not approved for this purpose and that the drug has been associated with significant birth defects in babies born to women who take the medication, Zofran has become a popular drug choice for obstetricians who hope to alleviate morning sickness in their patients. Zofran is typically prescribed to women during the first trimester of their pregnancy, which is when women are likeliest to experience nausea and vomiting. This time is also the most critical period in fetal development, when an unborn child’s organs and body tissues are beginning to form.
Harvard University researchers have tied Zofran to increased risks for cleft palate and research teams in Europe have discovered a link between Zofran and congenital heart defects. Parents allege that GlaxoSmithKline never released the information from these studies and that the drug maker neglected to warn obstetricians and pregnant women of Zofran’s potential risks.