Zofran Lawsuit Alleges That GlaxoSmithKline Was Aware Of Errors In Anti-Nausea Drug Study

January 13, 2016 – – ZofranLegal.com reports on another lawsuit filed against GlaxoSmithKline under case number 1:15-cv-00319-BLW in the United States District Court of Idaho on August 14th of 2015. Allegations within the lawsuit state that GlaxoSmithKline, (manufacturer of Zofran), was aware that animal studies done on the anti-nausea drug would be unable to accurately predict how pregnant women might be affected by it. The plaintiff claims that, despite knowing these test results and studies were unreliable, GSK chose to promote its anti-nausea drug unlawfully, because it was never FDA-approved to treat pregnant women or tested with human clinical trials for safety.

Reports indicate that when GlaxoSmithKline initially released Zofran to the U.S. Food and Drug Administration for approval, they also sent the results from four different animal studies that had been performed in order to evaluate the drug. Two of the four studies were completed on lab rats while the remaining two were completed using rabbits. The studies appear to have shown adverse health reactions to Zofran by pregnant animals. Results noted side effects ranging from intrauterine death and total litter loss, to developmental retardation of the offspring and fetuses of the animals.

Despite these results, after FDA approval, which was specifically given to use Zofran as a treatment for nausea associated with chemotherapy, radiation, and anesthesia, GSK went on to market their drug “off-label” as a morning sickness medication for pregnant mothers.

Today, after Zofran became widely prescribed “off-label” to expectant mothers, many of the mothers have filed suit. They allege that exposure to the drug while growing in utero caused their infants to develop severe congenital defects. Defects linked to Zofran in the lawsuit documents include cleft lip and palate, kidney defects, respiratory defects, clubfoot, tetralogy of fallot, transposition of the greater vessels, atrial septal defect, and ventricular septal defect. Some of the mothers involved, devastatingly, reported losing their children to fatally severe defects.

The attorneys at Monheit Law understand the seriousness of this issue. They wish to help ensure that all women who have taken Zofran and who later gave birth to a child with defects will have the opportunity to evaluate their legal options. These mothers and their families may be entitled to significant compensation. At this time, Monheit Law is offering free consultations for affected women.

To request more information or to ask questions,please contact the Zofran birth defect attorneys at 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

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