In 1991, Zofran (ondansetron) was introduced by manufacturer GlaxoSmithKline as an anti-nausea medication. Originally, Zofran was created to help treat nausea and vomiting for cancer patients undergoing certain types of chemotherapy. However, it quickly became popular among pregnant women as a way to combat morning sickness.
GlaxoSmithKline allegedly began promoting the drug for use against morning sickness. However, Zofran was never approved for that kind of usage. In fact, it’s been discovered that using Zofran during pregnancy can lead to certain types of birth defects. If your child was born with a birth defect, and you took Zofran during pregnancy, you may be entitled to compensation. Contact the Zofran birth defects attorneys at Steinger, Greene & Feiner today at 800-560-5059 for a free consultation.
In 2001, 10 years after Zofran was introduced, two GlaxoSmithKline employees filed a whistleblower lawsuit against the company, stating among other allegations that the company marketed Zofran as a safe way to combat morning sickness. Eventually, GlaxoSmithKline settled the suit, including an admission of guilt. However, that wasn’t the end of the ordeal.
In 2006, the patent on Zofran expired, and the first versions of generic ondansetron were approved by the Food and Drug Administration (FDA). By 2009, it had become the most-prescribed pharmaceutical treatment for morning sickness, overtaking promethazine.
Studies on the drug were conducted in 2012 and 2013. In the first one, conducted by researchers at Harvard and Boston University, showed that babies exposed to ondansetron during the first trimester had a 237 percent greater risk of developing a cleft palate. However, in 2013, a study by Pasternak showed no statistically significant link between ondansetron and birth defects.
That same year, a separate study by Andersen showed that babies exposed to ondansetron in the first trimester were 2 to 4 times more likely to develop a heart murmur or atrial septal defect (hole in the heart). In 2014, the Pasternak study was brought into question, as half the babies involved in study were exposed to ondansetron after 10 gestational weeks, at which point birth defects wouldn’t develop anymore.
In 2015, the first lawsuit was filed against GlaxoSmithKline, and many more followed. Early in 2016, a judge rejected the manufacturer’s arguments to dismiss the case, allowing the lawsuits to move forward.
There are two defects commonly tied to Zofran: cleft palates and “holes in the heart.” A cleft palate occurs when, early in pregnancy, there isn’t enough tissue in the lip or mouth area. As such, the upper lip and/or the palate (the roof of the mouth) don’t connect. In some cases, this defect is relatively minor, but even minor cases require surgery. Some of the most common complications with cleft palates include:
The other major birth defect associated with Zofran is a “hole in the heart,” or an atrial septal defect. This defect is a hole in the wall that separates the top two chambers of the heart. As a result, oxygen-rich blood can leak into oxygen-poor blood. If this defect is minor, it may heal on its own during childhood. However, major holes can cause more severe heart and lung problems, including heart failure and pulmonary hypertension.
Unfortunately, there usually aren’t any symptoms to diagnose atrial septal defect in babies. As such, if you told Zofran when you were pregnant, it may be advisable to have a doctor perform imaging on your baby’s heart to look for a hole. However, babies born when Zofran was first introduced may start displaying symptoms of atrial septal defect soon. These include:
If you took Zofran or generic ondansetron while you were pregnant, and your baby was born with a birth defect, you have legal rights. Contact the Zofran birth defects attorneys at Steinger, Greene & Feiner today for a free, no-obligation consultation. You may qualify to be part of a class action lawsuit, or you may be able to bring an individual lawsuit. This is especially true if your doctor prescribed ondansetron and didn’t warn you of the potential side effects. In this case, you may be able to bring a lawsuit against your doctor for medical malpractice.
Our experienced attorneys can review your case and help you figure out what steps to take next. We have recovered over $1 billion on behalf of our clients, and we can help you get the compensation you deserve. Call us at 800-560-5059 for a free, no-obligation consultation.