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The latest Zofran lawsuit to be filed in the litigation that has grown strongly since January 2015 comes from Louisiana. The allegations against GlaxoSmithKline, the manufacturer of Zofran, allege that the pharma giant knew that Zofran was unsafe for pregnant women based on prior testing, and over 200 adverse events reported to them by the year 2000. All allegations are similar to the allegations contained in close to fifteen other lawsuits suing GSK for child birth defects related to Zofran.

The Problem: Studies Suggest A Link

Epidemiology studies from Europe, which studied thousands of births over a considerable time frame came to conclusions suggesting that mothers who took Ondansetron during the first trimester had more than a 2 X increase in the risk of giving birth to a child with a septal defect. These studies had a 95% confidence interval and are commonly referred to as the Andersen and Danielsson studies. Another in the US, has linked cleft palate to ingesting Zofran during the first trimester, where the increased risk was calculated at 2.37 times higher. For a full summary and exploration of the studies, sample sizes and statistically significant information as it pertains to specific defects, take a look at our infographic here.

Newborn baby being checked for birth defectsZofran Lawsuit Birth Defect: Atrial Septal Defect

In this lawsuit, filed in federal court in Louisiana (case number: 2:15-cv-02323), the parent of a child who suffered an atrial septal defect (ASD) brought the lawsuit against GSK. The plaintiff resides in Louisiana and stated that had GSK warned that this could happen to her son, she would not have taken the risk, and her son would not have had to endure two heart surgeries and potentially more in the future. The complaint outlined that her son was born in 2006, which was when the patents on Zofran expired, and the generic version of Zofran, Ondansetron, hit the market.

An Atrial Septal Defect, is commonly known as a hole in the heart. While difficult to diagnose, these holes in the heart vary in size and severity. An ASD, allows blood to flow from one chamber to the next prior to oxygenating the blood, which in turn will make the heart work harder. The flow of this blood produces a sound as it swishes from one chamber to the next, and this is commonly referred to as a heart murmur. An ultrasound can detect an ASD, however often, that is not the case. Some ASD’s will self heal, while other larger ASDs require serious surgeries and life long monitoring. Answering Questions About Zofran Birth Defect Lawsuits is a portal designed for parents with questions about the litigation. It contains case summaries, information about the science, updates on the litigation, and much more. For any questions relating to the litigation, feel free to contact Michael Monheit.


Michael Monheit, Esq.

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