A San Francisco couple has filed a product liability lawsuit against GlaxoSmithKline (GSK) alleging that its anti-nausea drug Zofran (generic: ondansetron) caused their baby to born with a life-threatening congenital heart defect.
Free Confidential Lawsuit Evaluation: If your child or other loved one was born with a birth defect after the mother took Zofran during pregnancy, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
SF Couple Claims Zofran Caused Heart Defect
According to the lawsuit, the plaintiffs’ baby was born in 2009 and subsequently diagnosed with bicuspid aortic stenosis, a congenital heart defect characterized by a narrowing of the bicuspid aortic valve. The parents claim that Zofran, which the mother took ‘off-label’ for morning sickness during her first trimester of pregnancy, caused the defect.
The complaint, which was filed March 5 in the Superior Court for the State of California, San Francisco, is the nation’s fourth lawsuit alleging that Zofran caused birth defects. The case number is CGC-15-544524.
Plaintiffs Allege GSK Marketed Zofran as Morning Sickness Treatment
Bicuspid aortic stenosis occurs early in fetal development, typically during the first trimester, around the same time the mother is likely to experience symptoms of morning sickness. According to the lawsuit, the mother was prescribed Zofran early in her first trimester “to alleviate the symptoms of morning sickness.” The complaint notes that Zofran is not and has never been approved by the FDA to treat morning sickness.
However, according to the plaintiffs’ allegations, GSK “launched a marketing scheme to promote Zofran to obstetrics and gynecology […] healthcare practitioners, among others, as a safe treatment alternative for morning sickness in pregnant women” soon after the drug was released in 1991.
Zofran’s ‘Unreasonable Risk of Harm’
If GSK did in fact market Zofran for the treatment of morning sickness, the company did so without any evidence of the drug’s safety for use in this capacity. However, allegations in the new complaint go a step further. The plaintiffs claim that since at least 1992, GSK has been aware of evidence indicating that Zofran can cause birth defects, and the company has failed to adequately warn the public and medical communities about this risk.
According to the lawsuit, GSK has received more than 200 reports of birth defects associated with the use of Zofran during pregnancy, most of which were congenital heart defects like bicuspid aortic valve, which the plaintiffs’ son was born with.
Plaintiffs say that “GSK has failed […] to disclose these severe adverse events to healthcare providers or expectant mothers.”
Do I Have a Zofran Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Zofran Lawsuits. We are handling individual litigation nationwide and currently accepting new birth defects cases in all 50 states.
Free Confidential Case Evaluation: Again, if your child or other loved one was born with a birth defect after the mother took Zofran in pregnancy, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.