A couple has filed a Zofran birth defect lawsuit against manufacturer GlaxoSmithKline, alleging that the company fraudulently misrepresented the anti-nausea medication as a “wonder drug” for pregnant women.

Plaintiffs Matthew and Beth K. of Oregon filed the Zofran lawsuit on behalf of their minor son who was allegedly exposed to the medication in utero and was later born with a heart defect.

According to the Zofran birth defect lawsuit, Beth’s doctor prescribed Zofran during her first trimester of pregnancy for morning sickness relief. When her son was born, he was diagnosed with atrioventricular septal defect (AVSD), which is a heart defect, and had to undergo surgery.

The Zofran lawsuit claims that the child’s physicians believe that his heart defect will never completely resolve, and might require additional surgery. The plaintiffs allege that their son has been very limited in his ability to enjoy normal childhood activities as a result of his heart condition.

According to Matthew and Beth’s Zofran birth defect lawsuit, manufacturer GlaxoSmithKline began a nationwide fraudulent marketing campaign in 1998 claiming that the medication, which was only FDA approved to treat nausea related to chemotherapy, was in fact a safe treatment for morning sickness symptoms. 

By the 2000s, Zofran was the most prescribed drug in the United States for morning sickness treatment, despite the fact that GSK had no clinical knowledge that the drug was safe to take during pregnancy.

Beth claims that had she known about the risk of birth defects associated with Zofran she never would have taken the anti nausea medication.

The plaintiffs are suing GSK for fraudulent concealment, failure to warn and design defect. 

Birth Defects Allegedly Linked to Zofran

Hundreds of adverse event reports have been reported to the U.S. Food and Drug Administration claiming off-label use of Zofran led to various birth defects. The most commonly reported Zofran birth defect is heart deformities, followed by respiratory birth defects including pulmonary hypoplasia, which occurs when lungs only partially develop.

Other alleged Zofran birth defects include:

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

Zofran Birth Defect Lawsuits

The number of Zofran lawsuits parents are filing on behalf of their children born with birth defects continues to grow. In general, Zofran birth defect lawsuits allege that manufacturer GlaxoSmithKline fraudulently promoted Zofran as a safe and effective morning sickness treatment before conducting any medical trials to prove it’s safety for pregnant women.

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 Defect Lawsuit is Case No. 1:15-cv-01734-CL in the U.S. District Court for the District of Oregon, Medford Division.