Parents from Alabama have filed a Zofran birth defect lawsuit on behalf of their daughter against GlaxoSmithKline.

The minor child was reportedly born with multiple congenital heart defects, allegedly as a result of the mother’s Zofran use in pregnancy.

What is Zofran?

Zofran is a popular anti-nausea medication that is typically prescribed to chemotherapy patients to control nausea and vomiting. Ever since its release in 1991, it has become popular for its off-label use to treat morning sickness during pregnancy.

This drug is a 5-HT3 inhibitor that specifically blocks the sensors for nausea and vomiting, which make it a popular choice for pregnant women and their physicians. It is currently one of the most popular morning sickness treatments in America, despite the recent allegations made against the drug and its manufacturing company.

However, Zofran was never put through pre-clinical testing to determine the effects the drug could have on a fetus before the drug manufacturer promoted it as a morning sickness remedy.

Parents Claim Zofran Caused Daughter’s Heart Defect

Plaintiffs Allison K. and Johnathan G. were devastated after their daughter was born with severe congenital cardiac birth defects. Born on April 05, 2014, their daughter had to be rushed in for immediate medical care to stabilize her condition and was soon diagnosed with having a large heart atrial septa defect.

In the short period since their daughter was born, Allison and Johnathan claim she has had to undergo numerous medical treatments to treat her Zofran birth defects and is scheduled to undergo open heart surgery in Fall 2015. Medical bills are expected to mount for some time for the family, to which the Zofran lawsuit states is in direct consequence to the morning sickness drug.

As unfortunate as this case, Allison and Johnathan are only one example of an entire patient population who had been prescribed Zofran and met with tragic results. Despite never being officially approved to treat morning sickness, GlaxoSmithKline allegedly marketed Zofran directly to pregnant women.

While it is not illegal for doctors to prescribe a medication for off-label purposes, it is illegal for companies to market them for such. This has led the many parents to file legal action against the pharmaceutical company for concealing such vital safety information.

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.

Allison and Johnathan are hoping for similar results, and are pursuing legal action to get justice for their daughter’s injuries. At no point before or after her Zofran prescription, did the defendant disclose the possibility of birth defects or any other side effects. Allison insists that she never would have taken Zofran if she had known about the possibility of birth defects.

According to the Zofran birth defect lawsuit, GlaxoSmithKline had the civil responsibility of warning their clients and other patients of all potential Zofran side effects attached to the drug, because they rely on the given information.

So for being allegedly responsible for manufacturing, selling, distributing, and marketing a dangerous drug, Allison and Johnathan are suing GlaxoSmithKline. The charges include: negligence, false advertising, concealing information, and misrepresenting a product.

The Zofran Birth Defect lawsuit is Case No. 1:15-cv-01458-SGC, in the U.S. District Court of Northern Alabama, Eastern Division.