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Hundreds of parents say GlaxoSmithKline’s anti-nausea drug caused their children to develop birth defects. To date, at least 205 lawsuits are consolidated before Judge F. Dennis Saylor IV in the US District Court for Massachusetts. Meanwhile, claims filed in other courts around the country are being transferred to Boston and included in MDL 2657 [IN RE: Zofran (Ondansetron) Products Liability Litigation].

While too many Zofran lawsuits have been filed for us to provide coverage on each individual complaint, we’ll be highlighting several lawsuits over the coming weeks.

Boy’s Heart, Lung & Stomach Defects Caused By Generic Zofran, Mother Claims

On September 28, 2015, a mother from Virginia filed a Zofran lawsuit on behalf of her son F.B.

In court documents obtained by Monheit Law, the mother claims her son was born with numerous severe birth defects after being exposed to the drug in the womb. She says F.B. was born with three heart defects, a lung defect and a gastrointestinal anomaly.

Her complaint was originally filed in the US District Court of New Jersey under the case number 2:15-cv-07134. It was transferred to Boston on October 23, 2015 and is now logged as case 15-13712.

Plaintiff’s Son Braved Open-Heart Surgery, According To Complaint

Out of more than 200 Zofran lawsuits, this complaint may involve one of the most recent pregnancies. Plaintiff says she was prescribed the drug, a common “off-label” morning sickness treatment, in 2014, during the early stages of her pregnancy with F.B.

Her son was born on January 2, 2015 and quickly diagnosed with a host of congenital abnormalities. Many affected the boy’s heart, including complete atrioventricular canal defect and doublet outlet right ventricle.

  • Complete atrioventricular canal defect, according to Boston Children’s Hospital, is actually a cluster of associated abnormalities that result in a large hole at the center of a child’s heart. Smaller “hole in the heart” defects, like atrial septal defect and ventricular septal defect, can be involved, as can malformations of the valve that allows blood to flow between heart chambers.
  • Both of the heart’s two main arteries, the pulmonary aorta and the aorta, rise out of the heart’s right ventricle (pumping chamber), rather than out of two separate chambers in the condition known as double outlet right ventricle.

F.B. was also born with heterotaxy of the lungs, the mother claims. In this complex condition, a child’s lungs are aligned improperly within the chest. Plaintiff says her son was born with malrotation of the intestines, as well. Closely associated with heterotaxy syndrome, malrotation occurs when the loops of the stomach and small intestines line up incorrectly.

The mother says her son, still under 1 year old, has already undergone open-heart surgery.

Filing A Zofran Lawsuit Against Generic Drug Companies

Notably, the mother hasn’t just named GlaxoSmithKline, the manufacturer of branded Zofran, as a Defendant. Alongside that multinational pharmaceutical giant stands Glenmark Generics, an Indian company that produces an equivalent version of Zofran’s active ingredient, ondansetron. The mother says she was prescribed Glenmark’s ondansetron, rather than Glaxo’s Zofran.

Glenmark’s US subsidiary is headquartered in Clifton, New Jersey, which is why this mother, who actually lives in Virginia, initially filed her complaint there.

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