GlaxoSmithKline (GSK) has been hit with a lawsuit from a Texas mother who claims Zofran side effects caused her son’s birth defects.

Plaintiff Julia S. filed the Zofran birth defect lawsuit on behalf of her 8-month-old son, who was born in 2014 with congenital heart defects. Julia says she took Zofran to treat morning sickness during her first trimester of pregnancy.

Her son was reportedly born with numerous birth defects, including a heart murmur, fluid on the brain, thickened arteries, and multiple developmental delays. The Zofran birth defect lawsuit states that Julia’s son will require further surgeries to correct his numerous birth defects and will continue to suffer from developmental delays and other health problems, impairing his enjoyment of a normal life at home.

According to the Zofran lawsuit, GlaxoSmithKline illegally marketed their drug as a morning sickness treatment and failed to warn pregnant women and the medical community about Zofran risks. The Zofran lawsuit states GSK concealed their knowledge that Zofran studies linked the use of the medication during the first trimester to a potential risk of congenital malformations, such as cleft palate, cleft lip and heart defects, from healthcare providers and consumers in the United States.

Julia’s attorneys claim GSK knew that Zofran could cross the placenta based on animal studies dating as far back as three decades ago.

What is Zofran?

Zofran (ondansetron) is a prescription drug approved for prevention of nausea and vomiting among chemotherapy patients and following surgery. However, it is widely prescribed “off-label” to pregnant women for treatment of morning sickness, even though the FDA has not established that as a safe or effective use.

However, 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.”

Julia is seeking all general, consequential, compensatory, and punitive damages, and medical expenses for GSK’s alleged negligence in the off-label promotion of Zofran. She has demanded a jury trial for this case.

The Zofran Birth Defect Lawsuit is Case No: 5:15-cv-00034, in the U.S. District Court for the Eastern District of Texas, Texarkana Division.