A mother and father from Bergen County, New Jersey, have joined parents across the country who have sued the pharmaceutical manufacturer GlaxoSmithKline for making and marketing Zofran, an anti-nausea medicine that allegedly caused their children to be born with birth defects. The mothers in these Zofran birth defect cases took Zofran to treat their morning sickness, and gave birth to children with serious birth defects ranging from cleft palates to heart defects.

The plaintiff in this latest birth defects lawsuit took Zofran to treat her extreme morning sickness in the early stages of her pregnancy. Her condition was so extreme that she was diagnosed with hyperemesis gravidarum, which is a severe form of morning sickness consisting of chronic nausea and vomiting. She received Zofran intravenously at first, but was later prescribed the oral form of this drug for the rest of her pregnancy.

While the medication did work in treating her morning sickness, she gave birth to a baby son in September 2011 who suffers from club foot. The child’s condition is quite severe, with both feet rotated internally at the ankle. The baby had to undergo various surgical procedures to correct the deformity, including tissue manipulation, straightening, and casting the child’s legs and feet.

The child has also been required to wear a device called a “Mitchell Shoe” on each foot, along with a metallic bar that connects the feet. The purpose of these devices is to position the feet at a certain angle, helping to correct the physical defect. Due to how the device positions the legs, the boy has reportedly been having trouble sleeping and has not been able to learn to walk. The parents claim that the boy’s socialization skills have also suffered because of this alleged Zofran birth defect.

As a result of the defect, the child has experienced extreme discomfort in his first years of life, and his parents have spent much time and money addressing the condition.

Overview of Zofran Birth Defects Allegations

Numerous women have reported giving birth to children with skeletal problems, cleft lip, heart disease, and other complications after taking Zofran for morning sickness. Many of these women have filed Zofran birth defect lawsuits alleging that GlaxoSmithKline knew that Zofran may cause defects, but aggressively marketed the drug for off-label purposes, such as morning sickness treatment, anyway.

The FDA approved Zofran to treat nausea in chemotherapy and radiation treatment patients. Despite the fact that Zofran was never tested for morning sickness, GlaxoSmithKline started advertising it for that purpose after witnessing its popularity among newly-pregnant women. While it is not illegal for doctors to prescribe drugs for off-label purposes, it is illegal for companies to advertise them for such purposes.

GlaxoSmithKline has been in trouble over Zofran marketing in the past, spending $3 billion in 2012 to settle false advertising allegations with the U.S. Department of Justice.