ZofranLegal.com reports on the details of a Zofran birth defect lawsuit filed against manufacturer GlaxoSmithKline which alleges that the drug caused fatal heart defects within an infant girl. This tragic story is detailed in the lawsuit filed by her mother.
It is noted that the daughter was born with her heart on the right side of her body, rather than on the left as is normal. The mother shared that she used Zofran to combat intense morning sickness episodes during the first trimester of her pregnancy, (which is also when the fetus’ heart tissue initially develops). The young girl, who spent her entire 11-week life in the NICU connected to life support machines, ultimately passed away before her heart transplant procedure.
This complaint, case number 3:15-cv-00958, was filed in the United States District Court for the State of Tennessee in the Middle District of Nashville. As additional cases surface with similar allegations, it is important to realize that Zofran was never approved for use or safety during pregnancy. The drug was given approval by the United States Food and Drug Administration to treat individuals suffering from severe episodes of nausea and vomiting after undergoing chemotherapy, radiation therapy, or anesthesia.
Across the nation, however, expectant mothers are being prescribed the drug in an “off-label” fashion to treat their morning sickness. Most of these women have no idea that the drug was not approved for their use, in part because manufacturer GlaxoSmithKline has marketed the product to them, and to Ob/Gyns as well.
In this particular case, and like many other mothers have stated as well, the Tennessee mom indicates that her daughter’s exposure only occurred because of deceptive and fraudulent marketing by the manufacturer. In her suit, she discusses a similar problem in which the Federal Government charged GSK for the unlawful marketing of several of their drugs in 2012, including Zofran.
Additional details about the case state that the mother suffered from severe nausea, and was hospitalized for it early in her pregnancy. During these hospitalizations, she was given Zofran through an IV. When her daughter was born months later, an echocardiogram revealed that she had multiple congenital heart defects, including an atrioventricular septal defect, aortic insufficiency, and heterotaxy syndrome.
Several major studies support these allegations, linking Zofran exposure while in the womb to heart defects. In one Danish study entitled the “Pasternak study,” it was noted that women who were prescribed Zofran while pregnant were found to be nearly five times more likely to give birth to children with atrioventricular septal defects.
The attorneys at Monheit Law believe that many other families may be eligible to file Zofran lawsuits of their own. They offer free and confidential consultations to anyone who was given the drug while pregnant and who subsequently gave birth to a child with defects. These individuals and their children may be entitled to compensation.
For additional information on this topic or to ask questions, please contact Michael Monheit, Esq. of Monheit Law by calling 877-620-8411.
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Contact ZofranLegal.com:
Michael Monheit
1-877-620-8411
michael@monheit.com
1368 Barrowdale Road, Rydal, PA 19046
