Zofran Birth Defect Lawsuit Claims Drug Caused Hole In Baby’s Heart

November 06, 2015 – – ZofranLegal.com reports on another lawsuit filed against GlaxoSmithKline relating to their anti-nausea drug Zofran. The suit, filed by parents from Alabama, states that the drug, which was given to the mother to combat her morning sickness, subsequently caused their unborn child to develop several “hole in the heart” defects. The parents filed this claim on September 18th, 2015 under case number 2:15-cv-01638-RDP in the U.S. District Court for the Northern District of Alabama, Southern Division.

Documents showing details of the complaint state that the mother suffered from morning sickness, or pregnancy-related nausea, during her first trimester. During the first 8 weeks of her pregnancy, the woman was given the drug via an IV, and then took it in pill form for an additional month. The first trimester of pregnancy is the time women most commonly experience nausea problems, and it is also the time when fetal heart tissue does much of its developing. If drugs are administered that are unsafe for the child are during this time, it could potentially damage the developing tissue resulting in a birth defect. The plaintiff alleges that Zofran is a drug that isn’t safe for an unborn child and caused a cardiac defect.

The woman’s Zofran use is considered “off-label”, though she was unaware of this fact at the time. This means that the drug was not approved by the FDA to treat pregnant women, or tested for safety on this group of patients. The drug was approved by the U.S. Food and Drug association to treat individuals dealing with nausea from chemotherapy, radiation, or anesthesia procedures. After this approval, however, manufacturer GlaxoSmithKline marketed the medication directly to Ob/Gyns as a treatment for morning sickness.

The couple’s son showed problems immediately after being born. Details of the complaint say that he was born with a bluish hue to his lips and skin, indicating that he was not receiving enough oxygen, and also indicating an issue with his heart. It was discovered that the infant had three separate holes in his heart. The largest hole, an atrial septal defect, was located directly between the heart’s two upper chambers.

At age four, when doctors believed his body could better withstand surgery, the child had a procedure to repair the atrial septal defect. Details indicate that the hole being repaired was about 0.6 by 0.7 square inches in size.

Parents from across the nation have stepped up with allegations similar to those detailed in this suit. In addition, several research studies and have linked use of Zofran by expectant mothers to birth defects in their children. Currently, the attorneys at Monheit Law are working to help anyone who was prescribed Zofran while pregnant who subsequently gave birth to a child with defects. They offer free consultations to individuals in these situations who wish to explore their legal rights. These parents and children may be entitled to compensation.

For additional information on Zofran and birth defects, or to ask questions, please contact Michael Monheit, Esq. 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

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