A Mississippi family filed a Zofran lawsuit alleging the anti-nausea medication caused their daughter to be born with a cleft palate birth defect.

This is just one of many Zofran birth defects lawsuits recently filed against the drug’s maker, GlaxoSmithKline.

Zofran is a medication FDA approved for treating nausea and vomiting in patients when undergoing surgery and chemotherapy.

It has not been approved by the federal agency to treat morning sickness. However, many doctors prescribe this drug for off-label (non-FDA approved) purposes, most popularly to treat morning sickness during pregnancy.

It is, however, illegal for the manufacturer to promote use of the drug for any purpose not approved by the FDA.

This Zofran birth defects lawsuit alleges GSK has a duty to warn consumers and physicians of all possible side effects associated with taking its product. The plaintiffs allege the pharmaceutical company failed to warn this Mississippi couple of the birth defects their child was at risk of developing if taken during pregnancy.

Zofran Birth Defect Claims

Plaintiffs Patricia and Stephen T. are suing GSK on behalf of their daughter C.P.T., who was born with a cleft palate. That is a facial and oral deformity that occurs when the tissues of the face do not join properly during fetal development. The parents attribute the condition to her Zofran exposure while in the womb.

According to the couple’s Zofran cleft palate lawsuit, Patricia allegedly took Zofran during the first trimester of pregnancy. Months later, in January of this year, her daughter was born and immediately diagnosed with a cleft palate. This type of birth defect can impact a child’s eating, breathing, speech, and ability to speak.

Patricia and Stephen state that neither of their families have a history of birth defects and that the couple had one child prior to C.P.T.’s birth who was healthy and born without any birth defects.

Zofran Litigation

A research study performed by scientists from Harvard University and Boston University suggest that women who take Zofran while pregnant have a 2.37 percent increased risk of giving birth to a child with cleft palate.

Despite these findings, the U.S. Food and Drug Administration recently rejected a petition to change Zofran’s drug category, saying in an October 2015 statement that these studies “do not support a determination that there is an increased risk of fetal adverse outcomes.”

In light of this and other Zofran studies, many parents have become concerned about the role this anti-nausea medication may have played in their children’s development of birth defects. At least 34 Zofran birth defects lawsuits have been filed.

If you took Zofran for morning sickness while pregnant and gave birth to a child with cleft palate or other birth defects, you may have a legal claim.

The Zofran Cleft Palate Birth Defect Lawsuit is Case No. 5:15-cv-00070-DCB-MTP, in the U.S. District Court for the Southern District of Mississippi.