Gansen Law Group, P.C. is investigating potential lawsuits on behalf of women who were prescribed the anti-nausea medication Zofran (ondansetron) during their first trimester of pregnancy and delivered children with birth defects. While Zofran was never tested or approved for use by pregnant women, it is often prescribed off-label for morning sickness and hyperemesis gravidarum, a serious type of morning sickness that causes severe nausea and weight loss. Now, recent studies have shown that women who took Zofran are at a higher risk for delivering children with the following birth defects: The Gansen Law Group is skilled at handling cases in the following areas:

• Heart defects, including septal defects or holes in the heart or heart wall
• Cleft palates and other craniofacial defects
• Malformed or damaged kidneys

Several recent studies have found that Zofran may be linked to an increased risk of birth defects. For instance, in January 2012, researchers found that women who took Zofran or the generic medication ondansetron for morning sickness were at a higher risk of delivering children with craniofacial defects. Specifically, the study found that children exposed to ondansetron during the first trimester of pregnancy were twice as likely to develop cleft palates, and researchers said that further investigation into these findings was warranted. Then, in February 2013, researchers studied medical reports of more than 600,000 children exposed to Zofran during pregnancy, but found no increased risk of birth defects; however, a group of Swedish researchers reviewing the same medical reports found contradictory results. In their research, they found that women who took Zofran during the first trimester of pregnancy were, in fact, at an increased risk for delivering children with major congenital heart defects, including septal heart defects.

Most recently, a Toronto Star investigation found similar birth defect risks when reviewing medical records for Canadian women who submitted reports to the U.S. Food and Drug Administration’s Adverse Events Report Database. In their investigation, the Star found 20 cases where Canadian women were treated for morning sickness with Zofran and delivered children with various birth defects, such as heart defects and kidney malformations. In addition, the investigation found reports of two infant deaths after exposure to Zofran.

GlaxoSmithKline has faced several whistleblower lawsuits accusing the company of promoting various medications for off-label uses (i.e., uses that the FDA did not approve the drug for). Among other off-label promotions, the company allegedly promoted Zofran for the treatment of morning sickness, even though the drug was never approved by the FDA for this use. Furthermore, GlaxoSmithKline allegedly paid doctors kickbacks as incentives to prescribe a handful of its drugs for unapproved uses. In 2012, the company paid $3 billion in fines after it pled guilty to these charges; however, women who delivered children with birth defects and other serious side effects after taking Zofran were not compensated through these lawsuits, and doctors continue to prescribe the anti-nausea drug to expecting women.

Therefore, these women will need to file individual lawsuits against the drug’s manufacturer to seek compensation for their child’s injuries.

Gansen Law Group is experienced at handling cases involving these types of adverse drug reactions. Working with another firm, we were involved in obtaining a $48.2 million verdict in 2011.

Contact us for a free consultation. We will work with you to assess your case’s strengths and determine the best course of action to get you compensation. When considering a lawsuit, the goal for any client is to find the best way to maximize their recovery and allow them to live their lives to the fullest.