Yet another mother has come forward to file a Zofran birth defect lawsuit on behalf of her child, this time in California Superior Court, Alameda County. The March 6th complaint alleges that the now four-year-old child sustained a serious heart birth defect called supraventricular tachycardia, or SVT, a type of cardiac arrhythmia arising from improper electrical activity of the heart because of medication.
According to the Zofran lawsuit, the mother was prescribed the anti-nausea drug during the first trimester of pregnancy to alleviate nausea and vomiting. Her baby was born with SVT in 2010, despite there being no familial history of birth defects. Because of this heart defect, which the complaint asserts was the direct and proximate result of the mother’s treatment with Zofran, the child requires Digoxin to manage rapid breathing, shallow breathing, and shortness of breath. Had the baby’s mother been forewarned of the risks associated with the medication, the lawsuit contends that she never would have taken Zofran and that her child’s heart malformation would not have occurred.
Like other Zofran heart defect claims pending in U.S. courts, this case accuses GlaxoSmithKline of concealing information tying the anti-nausea medication to serious congenital malformations, including at least 200 reports the company received between 1991 and 2000. The lawsuit further claims that Glaxo illegally promoted the off-label use of Zofran as a morning sickness treatment, even though the U.S. Food & Drug Administration (FDA) has never cleared the drug for this indication.
Zofran birth defect lawsuits like the one recently filed in California point out that the medication has been listed by the FDA in Pregnancy Category B. This means that there have been no adequate, well-controlled studies examining its effects on a developing pregnancy. Yet an article published this past December in the American Journal of Obstetrics and Gynecology reported that 1 million expectant moms in the U.S. (about a quarter of all pregnancies) are prescribed Zofran or a generic equivalent every year to control nausea and vomiting.
The author of that report detailed a number of studies tying the drug to heart defects, oral clefts and other congenital malformations, as well as a newly-approved morning sickness treatment that appears to be safer for a developing fetus. The article concluded that in light of this alternative, this no need for women to be exposed to a medication of unproven maternal and fetal safety, and which has never been approved to treat nausea and vomiting related to pregnancy.
The Zofran lawyers at Bernstein Liebhard LLP are evaluating a number of claims involving birth defects, and they expect that the litigation surrounding this drug will continue to grow. If you think your child is suffering from a Zofran heart defect or other birth defect, please call our office today at (888) 881-3077 to learn more about your legal rights.