Parents in North Dakota recently filed a Zofran lawsuit against the drug’s manufacturer, GlaxoSmithKline (GSK), after their son was born without a kidney.
According to court documents filed at the United States District Court for the District of North Dakota, the plaintiff was prescribed Zofran during her first trimester of pregnancy to help her with severe morning sickness. Zofran is an anti-nausea medication, but it’s been approved by the FDA for use only for cancer patients and those undergoing surgery. Yet, seeing a profitable market in pregnant women experiencing nausea, GSK began promoting Zofran as off-label use for morning sickness.
The plaintiff took Zofran from late 2006 until early 2007. Her son was born in 2007, missing one kidney and with limited function of only 38% in the other kidney. Although kidney issues can result from genetic factors, the child’s mother and father state that they have never had missing kidneys or kidney issues, nor has the child’s paternal and maternal grandparents. Furthermore, the parents have another child who was born healthy. The mother did not take Zofran while pregnant with the oldest child.
In addition to taking Zofran during her first trimester, the plaintiff was also administered the drug via an IV during her third trimester. She was not told of any risks or dangers to her baby while taking Zofran. She indicated that had anyone warned her of the risks, she would have never taken Zofran.
Court documents indicate that the plaintiffs were not aware that how serious their son’s medical issues were until 2013, when the boy fell down and had an accident. After taking the child to get medical attention, a physician diagnosed him with a grade 4 injury to his only kidney. The physician also noticed that the child had a missing kidney, accompanied with other defects. As a result, the young boy now has undergo regular, long-term medical monitoring. Furthermore, should his only kidney drop to 25% function levels, the child may need dialysis permanently.
The plaintiffs are seeking more than $75,000 in damages against GSK.
Studies Linking Zofran to Birth Defects
More than 30 other parents have filed similar lawsuits against GSK after their babies were born with defects. In a few cases, women were forced to terminate their pregnancy after routine medical monitoring revealed life-threatening issues.
Numerous studies have been conducted on the risk of birth defects when taking Zofran, yet it seems as if GSK, who only performed a preliminary study on the medicine by testing it on animals, is ignoring all of the evidence. For instance, a 2014 study published by the National Institutes of Health (NIH) states that 1,349 infants whose mothers took Zofran were studied to find out the rate of birth defects. The results indicate that babies born to mothers who took Zofran while pregnant have a significant higher chance of developing cardiovascular defects.
In another study, published by NIH in 2012 indicates that taking Zofran while pregnant increases the risks of infants being born with cleft lip and cleft palate, as well as neural tube birth defects, such as spina bifida.
Keep in mind if you took Zofran while pregnant and your baby was born with birth defects, you have the legal to file for damages against the responsible party. You may be entitled to significant compensation for medical expenses, pain, suffering, and more.