New Zofran Birth Defect Lawsuit Alleges Zofran Caused Atrial Septal Defect
December 15, 2015 – – ZofranLegal.com reports on another lawsuit filed by plaintiffs in Louisiana. The suit alleges that Zofran use by the mother caused her unborn baby to develop severe birth defects while growing in the womb. This allegation is a common one. Dozens of other lawsuits have been filed stating much the same. These lawsuits have been consolidated in multidistrict litigation number 2657 in Boston, Massachusetts. They are being overseen by the Honorable Judge F. Dennis Saylor IV.
In details of this complaint, the plaintiff states that she was prescribed Zofran during the first trimester of her 2006 pregnancy. After her son was born, he was diagnosed with several congenital birth defects: atrial septal defect and partial anomalous pulmonary venous return. At this point, the child has had to undergo two corrective surgeries for these defects. The plaintiff states that Zofran and manufacturer GlaxoSmithKline are to blame.
In other Zofran birth defect lawsuits, the defects most commonly mentioned are kidney defects, respiratory distress, clubfoot, tetralogy of fallot, transposition of the greater vessels, atrial septal defect, ventricular septal defect, and cleft lip and palate. Some of the plaintiffs allege that their children’s defects were fatal, while others say their babies required multiple surgeries.
Zofran is an anti-nausea drug which was approved by the FDA many years ago. Coincidentally, however, the drug was never FDA-approved for expectant mothers or tested for safety on this consumer group. The U.S. Food and Drug Administration specifically approved Zofran to treat episodes of nausea and vomiting in patients who have undergone chemotherapy, radiation, or anesthesia. After this initial approval, however, manufacturer GlaxoSmithKline went on to market the drug as a morning sickness treatment to pregnant women and OB/Gyns nationally. This practice is termed “off-label” marketing, and it let the the “off-label” prescribing of many women.
Within her complaint, the plaintiff in this case addresses this “off-label” marketing, saying that GSK marketed the drug this way since 1998. She states that, had she been aware of this and aware of the risks of birth defects which have now been associated with the drug, she would never have used it to begin with.
Multiple studies have raised the same concerns. One study, done by the Slone Epidemiology Center in Boston and the Centers for Disease Control and Prevention from 2012 noted that mothers who used Zofran while pregnant had a twofold increased risk of their children developing cleft palate. Another study from 2014 noted that Zofran use during pregnancy increased the risk for babies to develop cardiac deformities, specifically cardiac septum defects.
Plaintiffs involved in the lawsuits surrounding the drug hope to spur a closer look at the risks connected to its use by pregnant women. As their cases await trial, the attorneys at Monheit Law are working to ensure that all affected mothers have the opportunity to investigate their legal rights. Women who used Zofran while pregnant and subsequently gave birth to a baby with defects may be entitled to significant compensation. These women and their families are offered free legal consultations at Monheit Law.
To request more information on Zofran birth defect lawsuits, or to ask questions, please contact Michael Monheit, Esq., lead attorney at Monheit Law by calling (877) 620-8411.
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Michael Monheit
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