Sixteen Families File A Zofran Lawsuit Alleging Cardiac Defects Caused By Drug
September 30, 2015 – – Zofranlegal.com has reported that at this time a total of sixteen Zofran lawsuits have been filed that allege the drug Zofran caused a cardiac defect in a total of eighteen children.
Congenital heart defects such as atrial septal defect, ventricular septal defect, and transposition of the greater vessels are just a few of the birth defects noted in the almost 50 total Zofran lawsuits, however, these defects are the most prominent. In every instance, the child had to undergo at least one life-saving surgery after their birth and, in some cases, multiple surgeries were performed. In one complaint in Ohio, a lawsuit filed in the U.S. District Court for the Northern District of Ohio Western Division under case number 3:15-cv-1166, parents claim that their newborn daughter died from a right ventricle heart defect caused by the drug, three days after her birth.
In each of these sixteen complaints, the mother of an unborn child was prescribed the anti-emetic drug Zofran to treat their morning sickness. Zofran was approved for use by the U.S. Food and Drug Administration in 1991. What the public wasn’t generally aware of was that the drug was only approved for treatment of nausea in patients undergoing chemotherapy and radiation treatments, or patients who had just been under anesthesia.
GlaxoSmithKline, the makers of Zofran, never completed human clinical trials to determine the effects the drug might have on expectant mothers and their unborn children. Still, the company decided to market the product “off-label” for the treatment of morning sickness, leading the medical community and the public to believe that it was a safe treatment. Since it first began this marketing campaign, the company has allegedly received over 200 reports of cases where a child was born with a birth defect after the mother took Zofran.
In recent years, several studies have been performed to establish the link between Zofran and birth defects in unborn children. One study performed in Denmark reported that women who took Zofran during the first trimester of their pregnancy were 4.8 times more likely to deliver a child with atrioventricular septal defects.
The U.S. Department of Justice took note of GSK’s “off-label” marketing of not just Zofran, but several of its drugs, and filed a lawsuit against the company. In 2012, GSK decided to settle, paying fines of around three billion dollars.
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Michael Monheit
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