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On July 27, 2015, a North Dakota couple filed a new Zofran lawsuit on behalf of their son, a minor. The case is currently pending in the U.S. District Court for the District of North Dakota.

According to their complaint, after the mother took Zofran during her pregnancy, she gave birth to a baby boy who suffered serious injuries. The parents believe manufacturer GlaxoSmithKline (GSK) should be held liable for medical expenses. They are seeking in excess of $75,000 in damages.

Mom Took Zofran During Pregnancy Without Being Aware of the Dangers

Like many mothers suffering from morning sickness, the plaintiff took Zofran to help ease her suffering during pregnancy. Though the FDA never approved Zofran for use in pregnant women, GKS advertised the medication to doctors and to patients as a safe solution for the severe nausea and vomiting that can sometimes be experienced by expectant mothers.

The plaintiff was prescribed Zofran by her doctor and took it between October 2006 and March 2007. Her son was born in 2007. She and her husband claim that their boy is missing a kidney, and suffered other injuries as well. The kidney he has left functions at only 38 percent.

Such a birth defect is sometimes genetic, but the plaintiffs claim that they have no history of such a defect, and that neither of they nor their parents or grandparents ever had missing kidneys. In addition, the baby has a brother who was born healthy and vibrant after the plaintiff carried him to full term without ingesting any Zofran.

The parents weren’t aware of the defect until October 2013 when their sun fell from a TV tray stand in their basement. Immediately after the fall the boy was diagnosed with a grade 4 of a possible 5 injury to the only kidney he has left.

It was then that doctors learned the six-year-old boy was missing a kidney and had other defects as well. With damage to the only kidney remaining, the boy had to be life-flighted and hospitalized for two weeks. He now requires regular care and monitoring. If the kidney he has drops to lower than 25 percent function, he will potentially require dialysis for the rest of his life.

The plaintiff was given Zofran in large doses through I.V. administration on several occasions during her first and third trimesters. She believes that it was this exposure to Zofran in utero that caused her son’s injuries. She claims she was unaware of the dangers associated with Zofran when she took it, and only recently learned about the medications’ connection to birth defects. Had she known then about the risks, she claims she never would have taken Zofran during pregnancy.

Studies Link Zofran to Increased Risk of Birth Defects

The plaintiffs’ Zofran lawsuit joins many others filed by parents who claim the medication, taken during pregnancy, caused birth defects. Several studies have linked the medication to heart and limb malformations.

In 2014, for example, researchers identified 1,349 infants born to women who had taken Zofran in early pregnancy between 1998 and 2012. They found a significant increased risk for cardiovascular defects. An earlier 2012 study found that treatments with drugs like Zofran, particularly in the first trimester, were associated with a potential increased risk of cleft lip and palate and other neural tube birth defects.

The plaintiffs in this case bring counts of negligence, breach of warranties, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, and false advertising.

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