In a recent Zofran birth defects lawsuit, a couple from Alabama is suing GlaxoSmithKline for the injuries their daughter allegedly incurred from Zofran exposure.

This popular anti-nausea medication has allegedly caused Zofran birth defects to develop in unborn babies for years, leaving several devastated families and lifelong consequences for children.

Plaintiffs Ciara and Jacob L. are suing the pharmaceutical giant after their daughter was born with congenital birth defects. The little girl was born on Jan. 24, 2013, with congenital heart defects and had to undergo immediate medical care after she was born.

The severity of these birth defects had forced the child to undergo surgery at only eight months old, and will most likely require additional surgeries.

According to the Zofran birth defects lawsuit, Ciara had been prescribed Zofran to treat her morning sickness in 2012 during the first trimester of her pregnancy. However, her morning sickness had persisted all the way though the second trimester, causing her to stay on Zofran longer than the typical prescription.

It is important to note that the risk for Zofran birth defects starts when it is first prescribed during the first trimester. Prolonged exposure may have increased the probability of birth defects, but that the risk of birth defects is present once the fetus is exposed to Zofran.

Overview of Zofran Birth Defects Allegations

Zofran was first approved by the FDA in 1991 as a drug treatment for nausea for patients undergoing chemotherapy or radiation treatment. At no point in time was Zofran ever approved to treat morning sickness, nor was it ever tested to determine if the drug could cause fetal damage.

Despite never being approved to treat pregnancy women, it was popularly prescribed to treat morning sickness by physicians. After noticing the high sales charts from morning sickness prescriptions, GlaxoSmithKline reportedly began focusing its Zofran marketing efforts towards pregnant women suffering early symptoms of pregnancy.

This proved to be a devastating decision for mothers and their unborn children, as none were aware of the potential dangers of Zofran birth defects. Additionally, this marketing campaign was illegal under federal regulations, as morning sickness was not an approved condition to be treated by Zofran.

While it is not illegal for doctors to prescribe medications for off-label purposes, it is illegal for companies to market them for such.

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.

Ciara, like many other mothers, insists that she never would have taken Zofran if she had known about the potential risk of birth defects.

The plaintiffs’ lawyers state that the defendant had the civil responsibility of warning their clients of these side effects, because they rely on the given information on the label.

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

This Zofran Birth Defects Lawsuit is Ciara L. & Jacob L. v. GlaxoSmithKline, Case No. 2:15-cv-01552-TMP, in the U.S. District Court of Northern Alabama, Southern Division.