A mother from Arkansas has filed a Zofran lawsuit alleging that the drug caused her newborn son serious birth defects.

According to the Zofran lawsuit, plaintiff Jody H. was prescribed Zofran during her pregnancy with her son to try and control morning sickness.

Her physicians prescribed her Zofran in the first trimester of her pregnancy and she continued to take it through the end of her pregnancy.

The Zofran lawsuit states that the child was born with a number of very serious birth defects, including a cleft palate and two club feet. The child has already required two surgeries to correct these alleged Zofran birth defects. The Zofran lawsuit holds that these injuries were the result of Zofran, and that the drug’s makers could have prevented this.

Zofran Health Studies

The Zofran lawsuit claims that the earliest animal trials of Zofran suggested that the anti-nausea drug could cause birth defects. The Zofran lawsuit states that the early animal trials of the drug back in the 1980s found that mammals exposed to Zofran during pregnancy miscarried and gave birth to young with severe birth defects at a significant rate.

Studies on rats and rabbits found birth defects, including slowed development, bone deformities, premature delivery, and “total litter loss” at higher rates than control groups.

Additionally, early reports of birth defects in humans taking Zofran began to come in after the drug hit the market. This included reports to FDA reporting databases and larger-scale epidemiological studies.

The Zofran lawsuit cites at least three recent epidemiological studies from two European countries that found that children with certain birth defects were more likely to have a mother who took Zofran during pregnancy than their peers. The Zofran lawsuit holds that the drug’s makers, GlaxoSmithKline (GSK) should have been aware that the drug could cause birth defects long before she received the drug.

Morning Sickness Relief

On top of this, the Zofran lawsuit alleges that the makers of the drug engaged in off-market labeling. In the U.S., drugmakers like GlaxoSmithKline must seek approval for every purpose for which they market a drug.

Recognizing that sometimes medical research outpaces the FDA approval process, U.S. law allows physicians to prescribe a drug “off-label” meaning the drug is prescribe for a purpose outside of its FDA approval. However, drugmakers are forbidden from marketing drugs for off-label use.

Zofran is only approved to treat nausea from chemotherapy and radiation treatments. The Zofran lawsuit holds that a lack of other morning sickness medications, coupled with an allegedly-illegal marketing campaign has lead to wide-spread off-label use among pregnant women.

The Zofran lawsuit alleges that “at least as early as 1998,” “GSK launched a marketing scheme to promote Zofran to obstetrics and gynecology healthcare providers.” This allegedly included paying or remunerating “thought leaders,” healthcare workers in positions of influence to promote the drug among their peers. In fact, in 1999, the part of the FDA responsible for enforcing marketing laws warned GSK that their promotional materials violated FDA regulations regarding off-label market.

Zofran Birth Defect Lawsuits

The Zofran lawsuit holds that the makers of Zofran reasonably should have known that Zofran could allegedly cause birth defects, and that instead of warning the public, GSK engaged in an illegal marketing campaign, ultimately leading to Jody H giving birth to a child with severe birth defects.

The Zofran lawsuit claims that this chain of actions by GSK makes them responsible and liable for medical costs, legal fees, and other costs allegedly incurred from Zofran lawsuits.

The Zofran Birth Defect Lawsuit is Case No. Case 1:15-cv-13797-FDS in the U.S. District Court for the Eastern District of Louisiana.