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Another family, residents of Montegut, Louisiana, have filed suit against GlaxoSmithKline, claiming the international pharmaceutical giant’s anti-nausea drug Zofran caused their children to be born with cardiac malformations. Unlike most lawsuits to date, this newest complaint claims that Plaintiffs had two daughters, born within a year of one another, and both were born with congenital heart defects as a result of prenatal Zofran exposure.

The lawsuit was initially filed in the US District Court for the Eastern District of Louisiana on March 3, 2016. Since being transferred to the US District Court of Massachusetts, it now bears the case number 1:16-cv-10544-FDS. You can view a PDF copy of the family’s complaint here.

Several recent studies, conducted in Denmark and Sweden, have found evidence that fetuses exposed to Zofran during the first trimester are at an increased risk of developing heart defects. In one study, which analyzed Danish birth records from 903,207 pregnancies, researchers discovered that babies exposed to Zofran prenatally were between two and four-times more likely to be delivered with cardiac septal, or “hole in the heart,” defects. For more information on the medical science behind allegations that Zofran may increase the risk for birth defects, visit

Zofran has become an increasingly, albeit “off-label,” choice for physicians hoping to ease their pregnant patients’ battle with nausea and vomiting. The drug is FDA approved to treat severe nausea and vomiting experienced by some cancer patients, as well as patients undergoing surgical anesthesia. It has never been approved as a morning sickness treatment. Plaintiffs claim that GlaxoSmithKline, despite this lack of approval, unlawfully promoted Zofran for use during pregnancy, even paying “kickbacks” to obstetricians and gynecologists who prescribed large quantities of the potent drug.

Identical allegations were first raised by the US Department of Justice, in what ultimately became the largest case of alleged health care fraud in US history, according to the Justice Department, a case GlaxoSmithKline settled for $3 billion. Plaintiffs, however, go further, claiming the company has hid evidence of Zofran’s alleged link to major birth defects for more than two decades.

More than 200 lawsuits make similar allegations. The claims have been “consolidated,” transferred to a single court in Boston for efficiency’s sake


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