In Brazoria, Texas, a couple claims the drug Zofran, which is a powerful anti-nausea medication that is manufactured by GlaxoSmithKline, caused tragic effects in two pregnancies. According to court documents, the couple’s first child died within a month after the mother gave birth. The child was exposed to the drug during the first trimester of pregnancy. The couple’s second child, who is 13 years old, has congenital kidney disease due to Zofran.

The couple’s complaint was originally filed on July 24, 2015 with the United States District Court in Delaware. Then, the Short Form Complaint was presented to the United States District Court in Massachusetts. In Massachusetts, there are an estimated 300 Zorfran lawsuits that were consolidated on September 6, 2016.

The Couple Believes Zorfran Lead to Fatal Congenital Heart Defects

The couple became pregnant in November of 2000. This was nearly two years before Thomas Gerahty and Matthew Burke reported that GlaxoSmithKline was responsible for promoting the drug for “off-label” use in women who were pregnant.

During an ultrasound, which was performed early in the pregnancy, the couple was told their unborn baby was healthy. Doctors did not recognize any signs of abnormalities at this stage in the pregnancy. However, when the mother started to experience morning sickness, her doctor prescribed her Zofran, which was taken in the first trimester of her pregnancy.

At 20 weeks, the mother had a routine diagnostic procedure. The plaintiff’s doctor found that the baby, H.H., had developed serious physical malformations. These malformations included a life-threatening heart defect. There has been research conducted in recent years that has shown taking Zofran in the first trimester of pregnancy can put an unborn child at an increased risk for developing heart defects. To this day, Zofran’s potential dangers are still studied all over the world.

The birth was classified as a “high risk birth.” H.H. was delivered by cesarean section on August 2, 2000. The parents reported, “there was a team of pediatric cardiac specialists” present when H.H. was born. According to the couple, “H.H.was whisked away from her mother.” H.H. was taken to a different hospital where she was placed on a ventilator after having trouble breathing.

The baby’s parents stated she would live “the remainder of her life” in the Neonatal Intensive Care Unit (NICU). H.H. passed away one month after being born. She had received “multiple surgeries and medical treatments.” The baby was born with a malformed aorta. The left side of the child’s heart was one-fifth the size it should have been.

The Second Child has Serious Kidney Defects

Two years after the death of the baby, the parents were expecting another girl. The mother experienced severe morning sickness and was once again prescribed Zofran in her first trimester.

B.H., which is the name of the girl, was also a high risk birth. On February 18, 2003, B.H. was born. However, right after birth B.H. started to vomit and had reflux. According to her parents, she was “unable to ingest and retain sufficient nutrition necessitating an extended hospital stay, and extensive testing.”

The child, who still suffers from reflux, urinary, and kidney maladies, had congenital kidney defects at birth. Her parents believe her health conditions are a result of Zofran.

Are Individuals Still Able to File Zofran Lawsuits?

With most Zorfran lawsuits, more than 280 families have stories that are very similar. There are women all over the United States who were prescribed Zofran, which was never approved by the Federal Food and Drug Administration (FDA) for use during pregnancy.

As a result of taking the drug during pregnancy, there have been many children who were born with severe congenital malformations. Because of the similarities, the cases have been consolidated in a Federal Court in Boston. However, lawsuits are still being filed as personal injury cases.

Mark Sadaka from Pharma Watch Dog, the leading Hazardous Chemical Attorney, has a national practice and works with clients from New York to Alaska.