A new Zofran lawsuit that alleges birth defects sustained by the plaintiff’s two children has been filed in the U.S. District Court, District of Pennsylvania, according to recent reports.
The case alleges serious problems that occurred after she took the anti-nausea medication during pregnancy—two of her children were born with cardiovascular problems, as well as other health issues. The children suffered Zofran heart defects that could have been avoided if the drug’s manufacturer, GlaxoSmithKline, adequately warned women about birth defects that may result if ingested during the first pregnancy trimester, which is the most crucial period of fetal development.
The company became aware of these issues through a number of resources, her Zofran lawsuit alleges. Not only did GlaxoSmithKline receive hundreds of complaints from women whose children sustained birth defects after being exposed to the medication; they also knew the results of clinical trials that assessed Zofran’s effect on newborns. Studies that tested the drug on animals also provided little proof of its safety and effectiveness in pregnant women.
As a result, the recently-filed lawsuit asserts that “Women ingested the drug because they innocently believed that Zofran was an appropriate drug for use in their circumstance.”
A case study released in January by Pediatric Emergency Care lends evidence to the potential link between Zofran and the risk for serious heart problems. The research looked at two children who were given the medication for symptoms of gastroenteritis, and later died after developing heart rates that were faster than normal. One of the children was 10 years old and otherwise healthy, and the other was 86 days old.
Even more important than the evidence against Zofran’s safety, though, is its lack of U.S. Food and Drug Administration (FDA) approval to treat extreme nausea in pregnant women. The medication was originally cleared on the U.S. market for patients undergoing chemotherapy and radiation treatments, or another type of surgery. It was never specifically approved to treat women with serious nausea during pregnancy, and has not been proven effective for this demographic. GlaxoSmithKline admitted this fact in a Toronto Star investigation that was published in June 2014.
Consider filing a Zofran lawsuit if you had a baby with heart defects or another type of birth defect. Call us now at .