Results of Japanese animal studies show link between fetal Zofran exposure and increased risk of birth defects.
Results of recent Japanese animal studies on the effects of fetal exposure to Zofran support claims by hundreds of U.S. plaintiffs in Zofran birth defect lawsuits: that exposure to the anti-nausea drug caused birth defects in their children. Just months after over 200 parents have stepped forward filing Zofran birth defect related lawsuits, the complaints have been transferred and consolidated to a single federal court in Boston. On December 11, 2015, Zofran manufacturer and defendant GlaxoSmithKline requested that these cases be dismissed. This motion was later dismissed by overseeing Judge F. Dennis Saylor IV, but it has been reported that it will be able to be requested again in the future. Plaintiffs responded to GSK’s request for dismissal, by noting that there was, “reason to believe that GSK had important evidence about the defects alleged […], and the link to Zofran.” To better illustrate this point, plaintiffs pulled in concerning information from the results from several “animal teratogenicity studies” which GSK had arranged be conducted in Japan. The study results seem to link animal fetal Zofran exposure to the development of congenital heart defects, an allegation that many plaintiffs who used the drug while pregnant say has happened to their own children. Plaintiffs claim that the Japanese studies highlighted pregnant animals who were exposed to Zofran and who subsequently gave birth to offspring with ventricular septal defects of the heart. They additionally indicate that these important studies took place after the drug had been given FDA approval for U.S. sales. A common point of contention, however, is that Zofran was never FDA-approved to treat expectant mothers or tested for safety on this consumer group. Despite this fact, however, manufacturer GSK reportedly went on to market the drug as a safe and effective treatment for nausea associated with morning sickness. If the concerning test result allegations are proven to be true, pharmaceutical giant GSK could face increasing public scrutiny for potentially concealing their product’s possible connection to the development of fetal birth defects. Originally posted by Michael Monheit on Digital Journal. Fetal Zofran Exposure – Ball & Bonholtzer Trial Attorney – Los Angeles