InfoSeptember 11, 2015 · Legal
New Zofran Lawsuit Filed In The State Of Louisiana
A new lawsuit has been filed in the state of Louisiana alleging that a child was born with a cleft palate because her mother was prescribed Zofran during the first trimester of her pregnancy.Press Release VideoLoading the player...Details(prREACH)
A new lawsuit has been filed in which GlaxoSmithKline, the makers of Zofran, have been named as the defendants.
A family has filed a claim in the United States District Court Western District of Louisiana under case number 5:15-cv-02090-EEF-KLH, alleging that their daughter was born with a cleft palate because her mother took Zofran during her pregnancy.
According to the complaint, the child in question was born on July 28th, 1998. When she was born she was diagnosed with a “secondary cleft palate”. The child had to undergo three corrective surgeries and speech therapy due to her birth defect. While she was still in the womb, her mother was allegedly prescribed Zofran during her first trimester to treat morning sickness.
The lawsuit further alleges that GSK knew of the increased risks associated with pregnant mothers taking the drug, including the potential for birth defects, however, the company failed to notify the public or the medical community. The complaint reads, “Plaintiffs would not have elected for the mother to use Zofran if they had known of the true risks associated with the use of Zofran.”
Zofran is an anti-emetic used to treat nausea and vomiting. It was initially approved by the U.S. Food and Drug Administration for use in patients suffering from nausea due to chemotherapy and radiation, or patients who experienced nausea after being under anesthesia. The drug was not approved for use in pregnant women.
Regardless, GSK allegedly carried on with marketing the drug as safe for use during pregnancy. By the year 2000, GSK allegedly knew of 32 cases of birth defects in children born to women who had taken Zofran during their pregnancy. The Louisiana lawsuit states that “GSK knew or should have known that, in fact, said representations and warranties were false, misleading and untrue in that Zofran was not safe and fit for the use promoted expressly warranted and intended by GSK, and ,in fact, it produced serious injuries in pregnant women and their babies.”
To date, the types of birth defects reported to be secondary to the use of Zofran during pregnancy including atrial septal defect (ASD), ventricular septal defect (VSD), heart murmur, kidney defects, cleft lip, and cleft palate. In some cases, the birth defect is so severe that the child has passed away. In most cases, the child must suffer through multiple surgeries in attempts to correct the defect.LinksContact
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