A new Zofran lawsuit was filed against GlaxoSmithKline in an Alabama federal court, alleging that the drug maker failed to warn the medical community and general public about serious side effects associated with the medication when taken during pregnancy.

The Zofran birth defects lawsuit is brought by Vicki R. individually and on behalf of her daughter, who is referred to as T.N. in the Zofran lawsuit. Vicki alleges that had she known about the unreasonable risks of harm, concealed by GlaxoSmithKline, she never would have taken the medication and her child would not have suffered damages from the drug.

Vicki claims that she took Zofran during the first trimester of her pregnancy to treat her morning sickness, and, as a result, her daughter was born with a congenital heart defect that required her to undergo open heart surgery at just four months old to repair the problems with her heart.

When she turned 4, T.N. had to have a pacemaker implanted, which had to be replaced again when she was 11 years old. It will have to replaced periodically throughout her life.

“T.N. was exposed to Zofran in utero during the periods when her cardiac tissues were forming and were susceptible to developmental insult from environmental exposure,” the Zofran birth defects lawsuit says.

The Zofran lawsuit includes claims for negligence, strict product liability, breach of warranty, fraud and misrepresentation, and loss of consortium.

Overview of Zofran Lawsuits

Zofran is an anti-nausea medication that is often prescribed to treat nausea in cancer patients receiving chemotherapy or radiation treatments.

The U.S. Food and Drug Administration (FDA) approved Zofran for the above stated uses in 1991. Doctors have been prescribing Zofran for both on-label and off-label uses since the medication entered the market.

An off-label use is any use not approved by the FDA. While it is illegal for drug manufacturers to market drugs for off-label uses it is not illegal for medical professionals to prescribe drugs for off label uses.

However, the Zofran birth defect lawsuit alleges that GlaxoSmithKline has been aggressively marketing Zofran for the off-label use of treating pregnancy related nausea.

The Zofran lawsuit claims that GlaxoSmithKline marketed Zofran as a wonder drug for pregnant women. According to this and other lawsuits, although Zofran was marketed to pregnant women, the pharmaceutical company never performed human studies to ensure the drug was safe for pregnant women and their unborn children.

The Zofran lawsuits also allege that the pharmaceutical manufacturers chose not to perform these safety studies out of fear that it would affect their profits.

GlaxoSmithKline did perform studies on pregnant animals using Zofran during the 1980s. These animal studies found evidence of intrauterine deaths and malformations in the offspring.

Studies performed by medical researchers have suggested that Zofran taken during pregnancy can cause several serious birth defects. Zofran birth defects include cleft lip, heart defects, kidney defects, poor fetal growth, musculoskeletal defects, and fetal death.

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.”

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.

The Zofran Birth Defects Lawsuit is Case No. 1:15-cv-00320-WS-C, in the U.S. District Court for the Southern District of Alabama.