Many women have taken Zofran, a strong nausea medication, to treat pregnancy morning sickness without knowing that this could lead to serious Zofran birth defects.

GlaxoSimithKline (GSK) has been accused of failing to warn pregnant or potentially pregnant women that using Zofran for morning sickness could affect their unborn child. As a result, many Zofran birth defect lawsuits have been filed.

About Zofran

Zofran was approved by the FDA as a nausea medication for patients undergoing chemotherapy, radiotherapy, or surgical anesthesia. This shows that Zofran is used for only the most serious nausea.

GSK has allegedly marketed Zofran off-label for morning sickness treatment as well despite the fact that no tests or trials were performed to evaluate the potential Zofran side effects that could follow.

While many women experience severe morning sickness, and Zofran may indeed help manage those symptoms, they allegedly have not been adequately warned about the Zofran side effects which could follow.

Zofran has already been involved in investigations concerning GSK’s off-label promotion habits. It is legal for a doctor to prescribe a medication for off-label uses, if they deem it necessary, but a drug manufacturer cannot promote off-label uses. 

In 2012, GSK settled a federal, civil false claim lawsuit alleging GSK had promoted Zofran for the treatment of morning sickness in pregnant women despite being approved only for post-operative nausea, and that GSK had paid doctors kickbacks for prescribing Zofran. In 2012, GSK settled that lawsuit along with three similar lawsuits regarding other GSK products for $1.043 billion.

Zofran Birth Defect Lawsuits

As a result of this alleged negligence and failure to warn, multiple Zofran birth defect lawsuits have already been filed against GSK. So far, six claims have been filed in California, Massachusetts, Minnesota, Montana, and Texas claiming that GSK promoted Zofran as a safe nausea medication for the treatment of morning sickness. Other claims state that GSK was aware of Zofran side effects years prior to these lawsuits.

Several studies have been performed, testing Zofran safety and potential Zofran birth defects. One study found that a pregnant woman using Zofran for morning sickness has a 30 percent chance of giving birth to a child with a Zofran birth defect.

Despite these findings, the U.S. Food and Drug Administration recently rejected a petition to change Zofran’s drug category, saying in an October 2015 statement that these studies “do not support a determination that there is an increased risk of fetal adverse outcomes.”

Zofran birth defects may include:

• Cleft lip and cleft palate (2.4-fold increased risk)
• Heart defects (doubled risk)
• Kidney defects
• Musculoskeletal defects
• Poor fetal growth

These birth defects can have a serious affect upon a family’s life. A Zofran birth defect lawsuit may help pay for any medical treatment required, cost of special education, loss of future earnings, pain and suffering, and many other damages.