On September 29, 2015, a federal lawsuit was filed in California by the parents of a child born with a serious heart defect that they contend was caused by the mother’s off-label use of Zofran that was prescribed by her doctor for nausea during her pregnancy.
The defendant is GlaxoSmithKline LLC (“GSK”), which manufactures and sells Zofran (ondansetron). Zofran is FDA-approved to treat severe nausea, such as the nausea experienced by cancer patients receiving radiation and/or chemotherapy treatments.
The parents’ harmful drug lawsuit alleges that GSK failed to conduct clinical studies regarding the efficacy and safety of prescribing Zofran to treat morning sickness during pregnancy despite hundreds of reports received by GSK of birth defects associated with the use of Zofran during pregnancy. Despite the results of recent studies that reported that pregnant women who use Zofran during pregnancy have double the risk of having babies with a congenital heart defect when compared to pregnant women who did not use Zofran during their pregnancy, the plaintiffs’ lawsuit alleges that GSK had not updated the warning label for Zofran to warn of the increased risk of having babies with congenital birth defects if Zofran is prescribed and used during pregnancy.
The plaintiffs’ child was born in 2007, suffering from severe congenital heart defects that required the child to have surgery when she was four. The plaintiffs allege in their harmful drug lawsuit that their child would not have been born with heart malformations had they been warned of the risk of Zofran use for pregnant women (they allege that the wife would have not used Zofran had she been properly warned about the risks associated with its use during pregnancy).
It has been reported that GSK pled guilty in 2012 to criminal charges that it had improperly and illegally promoted Zofran and other drugs it manufactured for off-label uses that were not approved by the FDA. Nonetheless, Zofran continues to be used for off-label purposes, such as for women suffering nausea and vomiting during pregnancy.
The plaintiffs are seeking both compensatory and punitive damages from GSK for negligence, misrepresentation, concealment, breach of warranty, and violations of California law.
The “Prescribing Information” for Zofran provided by GSK in May 2010, states, in part “Reproduction studies have been performed in pregnant rats and rabbits at I.V. doses up to 4 mg/kg per day and have revealed no evidence of impaired fertility or harm to the fetus due to ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.”
If you were prescribed Zofran during pregnancy and your child was born with birth defects, you should promptly find a drug claim lawyer in your U.S. state who may investigate your Zofran claim for you and represent you and your child in a drug claim against GSK and/or other(s), if appropriate.
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