A defective drug lawsuit filed on April 1, 2015 in federal court in Alabama claims that a child’s multiple birth defects were caused by his mother’s use of Zofran during her pregnancy, which was prescribed by her doctor to treat her nausea during her pregnancy.
Zofran, a prescription medication manufactured by GlaxoSmithKline, has been approved by the FDA for more than twenty-five years to treat nausea and vomiting associated with chemotherapy treatment, radiation treatment, and surgery for cancer. An off-label use of Zofran by some physicians has been to treat nausea and vomiting during pregnancy.
The plaintiff’s lawsuit alleges that her eight-year-old son was born with a high pallet, extra digits on his hands, a distended kidney, and has glaucoma, all of which are birth defects that the plaintiff’s lawsuit alleges were caused by Zofran. The child is a special needs child who does not talk, has seizures, and has been developmentally delayed since his birth. The plaintiff’s lawsuit seeks compensatory damages under Alabama state law for alleged negligent failure to warn, breach of warranty, negligence, and strict liability, among other alleged claims. The defendant alleges that there is no proof that Zofran causes birth defects and is seeking dismissal of the plaintiff’s defective drug lawsuit.
The child has been diagnosed as having Trisomy 13, which is a congenital birth defect caused by the duplication of the long arm of the 13th chromosome. The plaintiff’s lawsuit alleges that both she and the father of the child were genetically tested for chromosomal issues that could be responsible for their son’s Trisomy 13, and that neither parent had any such chromosomal abnormality.
The plaintiff’s lawyer reportedly stated after the federal lawsuit was filed, “[this case] was the first of several that have been filed in various federal courts claiming damages for birth defects caused by Zofran. While earlier studies indicated that Zofran did not cause birth defects, a more recent study published in the American Journal of Obstetrics and Gynecology found a 30 percent increased risk of major congenital malformations from Zofran use. It is very disturbing that GlaxoSmithKline chose not to warn pregnant women of the reported birth defects in children whose mothers were prescribed Zofran for nausea.”
GlaxoSmithKline reportedly issued the following statement (in part) regarding the plaintiff’s federal drug claim lawsuit: “Zofran is indicated for prevention of nausea and vomiting associated with chemotherapy treatment, and the prevention of postoperative nausea and/or vomiting. This important medication had been approved by FDA for over 25 years as safe and effective for these indications. Physicians may exercise their own discretion based on their knowledge and expertise to make an individualized determination of the risks and benefits when treating patients and prescribing medicines, including Zofran. Zofran is a valuable treatment option for many patients, and GSK intends to vigorously defend itself in these cases.”
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