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Oregon Family Files New Zofran Lawsuit

The parents of a child that was born with a heart defect have filed a lawsuit against GlaxoSmithKline claiming that the company’s reckless off-label marketing of their anti-nausea drug Zofran contributed to the child’s development of a serious birth defect.

Wednesday, October 7, 2015 - One of the most recent Zofran birth defect lawsuits claims that GlaxoSmithKline's (GSK) anti-nausea medication caused serious heart complications for the child of an Oregon couple. The claim is similar to more than 60 that parents have filed around the country focused on the off-label marketing of GSK's Zofran medication to treat morning sickness for pregnant mothers. The Oregon lawsuit is likely to be added to the multidistrict litigation that was recently consolidated by the Judicial Panel on Multidistrict Litigation.

The child at the heart of the lawsuit was born with an atrioventricular septal defect, which is a rare congenital heart defect that cause the child to undergo open-heart surgery when it was only five-months-old. This defect takes the form of a large hole that is located near the center of the heart and keeps it from functioning properly. The mother had been prescribed Zofran during the first trimester of her pregnancy to help quell her morning sickness symptoms.

The Gold Hill, Oregon family that filed the recent lawsuit against GSK claim that the company marketed Zofran off-label to the mother of the child, bypassing FDA regulations in the proces. Attorneys for the family claim that this encouraged and enabled doctors to prescribe the medication to pregnant women even though it had not gone through the proper testing to check for side effects such as a propensity to raise the risk for birth defects.

GSK has been the focus of off-label marketing claims in the past, paying $3 billion in 2012 to settle a series of charges and lawsuits brought by the U.S. Department of Justice over a number of infractions in addition to the off-label allegations. The practice is used by pharmaceutical companies to help drum up profits for a drug that might not pass the necessary checkpoints to be approved by the FDA to treat a desired symptom. Plaintiffs are claiming that GSK was aware of the possibility of Zofran not making through the testing process because of the drug's link to birth defects and instead chose to market the drug to treat morning sickness to doctors off-label.

Zofran was initially developed to help treat nausea symptoms in chemotherapy and surgery patients after undergoing procedures. The medication is one of the strongest options for anti-nausea treatments, and for this quality was targeted for use to treat morning sickness symptoms. Unfortunately, more Zofran research is pointing to the existence of a link between the drug and an increased risk of birth defects.

Lawsuits filed around the country were recently consolidated into multidistrict litigation by the Judicial Panel on Multidistrict Litigation. The transfer order, which was given in early October, transferred the lawsuits to the District of Massachusetts federal court. A number of cases, including this recent one filed in Oregon, are expected to join the MDL along with the ones originally transferred as the litigation progresses.

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Onder, Shelton, O'Leary & Peterson, LLC is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. Onder, Shelton, O'Leary & Peterson has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others, and other law firms throughout the nation often seek its experience and expertise on complex litigation.