On July 17, 2015, plaintiffs from Massachusetts filed a new Zofran lawsuit in the U.S. District Court of the District of Massachusetts. They claim that after the mother took Zofran during her pregnancy, she gave birth to a baby boy who suffered from serious birth defects.
This is one of over 30 Zofran lawsuits now filed in courts across the country against manufacturer GlaxoSmithKline (GSK). At least three other similar lawsuits are proceeding in the same court.
Child Suffers Zofran Heart Defect
According to their complaint, the plaintiffs, as parents of the child, blame GKS for failing to provide adequate warnings about the drugs’ link to potential birth defects. The mother took Zofran to prevent the symptoms of morning sickness during her first trimester of pregnancy. She gave birth to her baby boy in 2007.
Doctors diagnosed the child with a congenital heart defect. After birth, echocardiograms showed that he suffered from a ventricular septal defect, which is a hole in the wall that separates the two ventricles of the heart. He was also diagnosed with a systolic ejection heart murmur.
Because of these defects, which the parents believe were caused by Zofran, the child has been under continuous monitoring since birth. The defects put him at an increased risk for serious injuries should he develop any type of infection. His parents also have to worry about a potential artery blockage, which could be fatal without immediate surgery.
Considering all these risks, doctors have recommended the family stay close to an emergency facility at all times. Since the defect hasn’t healed in eight years, they’ve also told the parents that their son’s defect will likely be permanent.
The mother claims that there is no family history of heart defects, and claims that she was unaware of the potential risks when taking Zofran.
Zofran Never FDA-Approved for Pregnant Women
Though Zofran was never FDA-approved for use in pregnant women, GSK promoted it as a solution for morning sickness. The FDA cleared the drug in 1991 for the treatment of vomiting and nausea after surgery and during cancer treatments, but it was never established by the FDA as a safe option for expectant moms.
Nevertheless, GSK marketed the drug “off label” starting in 1998 for morning sickness, despite the fact that it allegedly never conducted a clinical trial establishing the drug’s safety in this vulnerable population. In fact, GSK allegedly excluded pregnant women from the trials used to gain FDA approval for the medication.
Zofran became the most prescribed drug for treating morning sickness in the 2000s. Yet as early as 1992, GSK was receiving reports of birth defects allegedly associated with the drug, and had at least 32 reports by the year 2000. It has received over 200 reports to date.
Studies Link Zofran to Heart Defects
GSK was later fined over $1 billion for its off-label promotion of drugs like Zofran. In addition to the reports it received linking Zofran to birth defects, the company was also allegedly aware of scientific studies that raised red flags concerning the drug’s potential side effects.
In 2014, for example, researchers found a significant increased risk for cardiovascular defects in babies born to women who took Zofran during pregnancy—notably a cardiac septum, “hole in the heart” defect.
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