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Michael Monheit
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New Jersey Mother Says Zofran Caused Heart Defects, Facial Dysmorphia


In a recent Zofran lawsuit, a mother from Hainesport, New Jersey claims that her child was born with countless birth defects after being exposed to GlaxoSmithKline’s popular nausea drug.

She says that her daughter, named as B.B. in court documents, suffers from a staggering number of congenital abnormalities, including two heart defects and dysmorphic facial features.

The mother says she suffered from morning sickness and migraines during the first trimester of her pregnancy with B.B., and was prescribed brand name Zofran to treat these common, but often debilitating, effects of pregnancy. B.B. was born on May 13, 2007.

Now 9 years old, B.B. was allegedly born with both atrial and ventricular septal defects, so called “hole in the heart” abnormalities in which barriers in the heart fail to close properly. The child was born with a low birth weight, her mother says, and continues to struggle with developmental delays that require specialized education services.

Hydronephrosis, a kidney condition, is also claimed, as are a host of facial abnormalities. According to court documents, B.B. was born with a high palate, recessed chin, small jaw and low set ears. Her palms are crossed by one crease, rather than three, the mother claims. B.B. was also born with clinodactyly, a condition in which pinky fingers are bent inward from the topmost knuckle.

Genetic testing has failed to detect a genetic anomaly, and the mother says her family has no history of birth defects. But a number of recent studies have linked Zofran, a drug that was never approved for use during pregnancy, to major birth defects like “hole in the heart” abnormalities and cleft palate. In 2013, researchers from Denmark found evidence that unborn children exposed to Zofran are between two and four times more likely to be born with cardiac septal defects.

Almost 300 families have sued GlaxoSmithKline over birth defects they believe were caused by prenatal exposure to Zofran. The drug’s active ingredient, ondansetron, is approved to treat severe cases of nausea and vomiting caused by chemotherapy, radiation therapy and surgical anesthesia. But in their lawsuits, parents say GlaxoSmithKline quickly identified another patient population to exploit: pregnant women.

The mother’s lawsuit was originally filed in the US District Court of New Jersey on March 15, 2016, but soon transferred to the Boston court in which more than 270 other Zofran lawsuits have now been consolidated. This most recent filing represents an amended complaint, submitted to the US District Court of Massachusetts on August 1, 2016.

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