Two Louisiana moms have filed a Zofran lawsuit claiming the anti-nausea medication caused the life-threatening birth defects of their children. Plaintiffs Stacy C. and Ashley S. filed the birth defect lawsuit on behalf of themselves and their minor children accusing Zofran manufacturer GlaxoSmithKline (GSK) of marketing the medication as a safe treatment of morning sickness when they knew it had not been adequately tested for possible birth defects.

The Zofran birth defect lawsuit claims that GSK fraudulently represented to pregnant women and the medical community that the medication had been tested; that using Zofran while pregnant did not increase the likelihood of birth defects; and that the drug was considered a “pregnancy category B” which means animal studies showed no signs of fetal risk.

The Louisiana mothers, who were both prescribed Zofran for morning sickness relief and believed it to be safe to take during pregnancy, allege GSK intentionally deceived them with claims of that the medication was safe based on studies. They now believe that GSK’s “inadequate testing evinced a callous, reckless, and willful indifference to the health, safety and welfare of pregnant women and their unborn children.”

Plaintiff Stacy took Zofran to alleviate her morning sickness symptoms during the first trimester of her pregnancy. She claims she was unaware based on Zofran’s marketing that she was inadvertently exposing her unborn child to possible birth defects. Stacy’s child was born with several congenital heart defects which required surgery to correct. The plaintiff claims there is no history of heart problems in her family and she further alleges that she previously gave birth to a healthy child and did not take Zofran during that pregnancy.

Plaintiff Ashley claims she took the anti nausea drug Zofran during the first trimester of her pregnancy and later gave birth to a daughter with accelerated ventricular arrhythmia which is a serious heart defect that nearly caused her death. Ashley’s child required on-going medical monitoring and testing for the first five years of her life. 

The plaintiffs are seeking $75,000 in damages that include medical expenses and permanent pain and suffering.

Birth Defect Studies

According to the Zofran lawsuit, GlaxoSmithKline conducted animal studies which found that fetal exposure caused malformations in offspring and intrauterine deaths. The plaintiffs also claim GSK later conducted a study in humans which confirmed that “ingested Zofran readily crossed the human placenta barrier and exposed fetuses to substantial concentrations.” Plaintiffs Stacy and Ashley believe GSK knew of the birth defect risks based on these studies yet concealed the information to pregnant women and physicians.

Since its release on the market, several other Zofran birth defects studies have taken place. In 2013, a Danish study researched hundreds of thousands of pregnant women and discovered those who took Zofran during the first trimester were up to 40 percent more likely to have a child born with a birth defect. 

In addition, a 2014 Swedish study concluded that women who took Zofran during pregnancy had a 60 percent greater risk of having a child born with a heart defect.

Zofran Lawsuits

Hundreds of Zofran birth defects have been reported to manufacturer GSK. Some of the most common birth defects include: cleft palate, cleft lip, musculoskeletal defects, kidney defects, congenital heart defects, congenital diaphragmatic anomaly, intrauterine death and stillbirths.

Numerous Zofran lawsuits have been filed accusing GSK of knowing the risks of birth defects but failing to warn patients.

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.

If you had a child born with a birth defect after taking Zofran, contact a birth defect attorney to see if you have legal claim.

The Zofran Birth Defect Lawsuit is Case No. 6:15-cv-01815, in the U.S. District Court for the Western District of Louisiana.