A Zofran birth defect lawsuit has been filed by a mother who took the medication for morning sickness relief only to be forced into premature labor in hopes that her child would survive.

The plaintiff claims that she was prescribed Zofran to help alleviate her morning sickness symptoms during her first, second and third trimesters despite the fact that the U.S. Food and Drug Administration has not approved Zofran for this purpose.

At 27 weeks gestation, the plaintiff went in for a routine stress test only to find out that her unborn daughter’s heart rate was continually dropping. An ultrasound confirmed that the baby was in serious trouble as doctors informed the patient that her child developed a fetal condition medically referred to as hydrops fetalis.

This life-threatening condition occurs when fluid accumulates in two or more of the fetal compartments, including ascites, pleural effusion, pericardial effusion, and skin edema.

The mother was rushed to the hospital and forced into premature labor in an attempt to save the baby’s life. Physicians informed the mother that her 2 lb., 2 oz. daughter suffered from multiple birth defects and may not live.

In total, the baby girl was born with a hole in her heart, skull deformities, pulmonary hypertension, sepsis, blood clots, stomach issues, hernia and jaundice. In addition, physicians noted that the child suffered two strokes.

After spending 13-months in the hospital, the child was deemed well enough to leave. However, the mother claims that her child now requires 24-hour nursing care at home.

The Zofran lawsuit states that the plaintiff now faces a $6 million dollar hospital bill.

Zofran Birth Defect Risks

The anti-nausea medication was approved by the FDA to help cancer patients going through chemotherapy. However, each year nearly 1 million women are prescribed Zofran “off label” to use during pregnancy for morning sickness.

Zofran (ondansetron) has been the subject of multiple studies after hundreds of adverse event reports have been filed with the U.S. Food and Drug Administration claiming that the drug causes severe birth defects.

Of the hundreds of FDA adverse event reports, the most common Zofran birth defect is heart deformities followed by respiratory birth defects including pulmonary hypoplasia, which occurs when lungs only partially develop.

Reported Zofran birth defects include:

• Kidney defects
• Cleft lip
• Cleft palate
• Congenital diaphragmatic anomaly
• Congenital heart defects
• Respiratory defects
• Musculoskeletal defects
• Intrauterine death
• Stillbirth
• Spontaneous abortions

Zofran Birth Defect Lawsuits

Multiple lawsuits have been filed by parents who claim the anti nausea medication caused their child to be born with birth defects. Plaintiffs allege that manufacturer GlaxoSmithKline had no clinical knowledge that the medication was safe to take during pregnancy but intentionally marketed the product “off label” as a safe and effective morning sickness treatment.

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.

If you took Zofran while pregnant and later had a child born with a birth defect, contact a Zofran attorney to find out if you have legal claim.