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

Plaintiff Tomisha L. filed the Zofran birth defect lawsuit on behalf of her daughter, who was born in 2000. Tomisha took Zofran to treat morning sickness during her first trimester of pregnancy.

Her daughter was born with several heart defects, including a “hole in the heart” (atrial septal defect), right ventricular hypertension, and aortic arch hypoplasia. She also had facial dysmorphia, low set ears, hearing loss, sensitivity to light, ingueno hernia, and webbed toes.

The Zofran lawsuit further specifies that Tomisha’s daughter has required at least 13 different surgeries and continues to suffer from developmental delays and other health problems. According to the Zofran birth defect lawsuit, GlaxoSmithKline illegally marketed its drug as a morning sickness treatment and failed to warn pregnant women and the medical community about the findings of Zofran studies that have linked use of the medication during the first trimester to a potential risk of congenital malformations, such as cleft palate, cleft lip and heart defects.

The Zofran lawsuit states “GSK not only concealed this knowledge from healthcare providers and consumers in the United States, and failed to warn of the risk of birth defects, but GSK also illegally and fraudulently promoted Zofran to physicians and patients specifically for the treatment of morning sickness in pregnant women.” Tomisha’s attorneys claim GSK knew that Zofran could cross the placenta based on animal studies from the 1980s.

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 is a safe or effective use.

Since 1992, GSK has allegedly received over 200 reports of birth defects in children exposed to Zofran. In addition, at least four large-scale epidemiological studies have found evidence that Zofran increases the risk of birth defects, especially heart defects.

According to numerous Zofran lawsuits, GlaxoSmithKline performed studies in the mid 1980s which showed that Zofran crossed the placenta in rats and rabbits during pregnancy. Despite the potential pregnancy risks with Zofran, GlaxoSmithKline allegedly promoted the use of its drug among pregnant women to capitalize on the large market created by women suffering from morning sickness, which is a common complication associated with the first trimester of pregnancy.

Instead of updating warnings, GSK allegedly instructed sales representatives to market Zofran as a treatment for morning sickness.

Zofran Lawsuits

Over the coming months and years, as more families learn about the link between the anti-nausea drug and birth defects, it is expected that additional Zofran lawsuits will be filed on behalf of children throughout the United States. Tomisha is seeking all general, consequential, compensatory, and punitive damages, and medical expenses for GSK’s negligence in the off-label promotion of Zofran.

The Zofran Birth Defect Lawsuit is Case No: 1:15-cv-10429-FDS, in the U.S. District Court for the District of Massachusetts.