A Texas mother has recently filed a Zofran birth defect lawsuit alleging that the anti-nausea medication caused her child to be born with numerous congenital birth defects. This is one of several Zofran lawsuits that Zofran’s manufacturer, GlaxoSmithKline, has faced over birth defect allegations.

After being prescribed Zofran to treat morning sickness early in her pregnancy, the plaintiff gave birth to a child in 2014 who suffered from a heart murmur, fluid on the brain, thickened arteries, and multiple developmental delays. Although doctors prescribe Zofran for severe morning sickness, GSK has allegedly never studied the safety of Zofran use in pregnant women or the risks Zofran may pose to growing fetuses. The FDA has approved the strong medication to treat the kind of nausea that follows cancer treatments like chemotherapy and radiation, but has not approved the drug for use during pregnancy.

Despite the fact that Zofran is not approved to treat morning sickness, GSK has allegedly marketed the drug to pregnant women for years. The Zofran birth defect lawsuit claims that GSK began marketing the anti-nausea medication as a morning sickness treatment almost as soon as the drug hit the market. 

While it is generally legal to use a drug for off-label purposes, it is not legal for a drug manufacturer to directly market a drug for off-label use, and GSK has a history of pushing the boundaries with Zofran marketing.

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 Defects

Various studies have found an increased risk of birth defects in the children of Zofran users. One study found that Zofran use could increase the risk of birth defects by as much as 41 percent. Another study found that women who used Zofran to treat morning sickness were 60 percent more likely to give birth to a child with a congenital heart 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.”

During initial trials performed by GSK in the 1980s, researchers found that Zofran could cross through the placental barrier in animals. However, GSK allegedly did not report any harm and did not study Zofran’s safety for pregnant women.  

Zofran Birth Defect Lawsuits

So far, plaintiffs have filed seven Zofran birth defect lawsuits claiming that GSK marketed the anti-nausea medication for off-label uses. The Zofran lawsuits allege that the drug’s manufacturer failed to warn against Zofran birth defects and improperly promoted the medication as a treatment for morning sickness, causing multiple women to give birth to a child with a Zofran birth defect. 

Zofran birth defect lawsuits can help a family win compensation for the pain, suffering ,and financial difficulties arising from GSK’s alleged off-label promotions.