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Lawsuit allegations contend drugmaker knew of Zofran risks

A recent lawsuit filed in a federal court in Philadelphia alleges that the maker of the prescription drug Zofran knew about the risks and potential side effects of the drug but did not warn patients. The suit alleges that the manufacturer of Zofran knew of risks to unborn fetuses but failed to adequately warn pregnant mothers who were using the drug to treat symptoms of nausea associated with pregnancy.

According to Court documents in one case (Flynn v. GlaxoSmithKline, case number 2:15-cv-00709-PD; filed 2/12/15), Zofran was designed to treat nausea symptoms associated with certain cancer treatments like chemotherapy. However, the suit claims that the manufacturer of Zofran marketed the drug "off-label" as a safe treatment for morning sickness without ever testing the drug for potential risks to pregnant mothers or unborn babies.

The Complaint provides that "unlike another anti-nausea prescription drug available on the market - which is FDA-approved in the United States for treating morning sickness in pregnant women - GSK (the manufacturer) never conducted a single clinical trial before marketing Zofran to pregnant women." The lawsuit further alleges that "GSK simply chose not to study Zofran in pregnant women or to seek FDA approval to market the drug for treatment during pregnancy."

The lawsuit alleges that the drug manufacturer chose not to conduct studies for fear that it would hurt profits. The lawsuit also claims that GSK knew that the drug was unsafe because of animal studies that indicated evidence of intrauterine malformations in offspring. According to the lawsuit this provides proof that Zofran could cross the placenta and affect fetuses.

The Manchin Injury Law Group is currently accepting Zofran cases. Zofran has been shown to cause birth defects in babies whose mother took Zofran while pregnant. Birth defects include heart defects, heart murmur, atrial septal defect (hole in the heart), musculoskeletal problems, mouth deformity, kidney defects, intrauterine growth restriction, jaundice, death, and other birth defects. If you or a loved one has a baby with a birth defect and the mother took Zofran during the pregnancy, contact us now.

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