February 19, 2015 — A lawsuit has been filed by a woman from Massachusetts who took Zofran while pregnant and had a baby with a birth defect.

The lawsuit was filed on February 16 on behalf of a child, A.S., who was born in 2000 with numerous birth defects. The child’s mother, Tomisha LeClair, took Zofran during the first trimester of pregnancy to alleviate symptoms of morning sickness.

After birth, the child was diagnosed with several heart defects, including atrial septal defect (“hole in the heart”), right ventricular hypertension, and aortic arch hypoplasia. The child also has facial dysmorphia, low set ears, hearing loss, sensitivity to light, ingueno hernia, and webbed toes.

The child has had ten surgeries, which have impaired her development and led to substantial developmental delays.

The lawsuit accuses GlaxoSmithKline (GSK) of failing to warn about evidence linking Zofran and birth defects:

“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 pregnancy women.”

According to the complaint, GSK knew about the potential risk of birth defects from Zofran for decades. Studies in rats and rabbits in the 1980s showed that Zofran crossed the placenta. Later studies have confirmed that it crosses the human placenta.

From 1992 to the present, GSK has received more than 200 reports of birth defects in children exposed to Zofran. In addition, scientists have conducted large-scale epidemiological studies that have demonstrated a risk of birth defects.

Instead of updating warnings on Zofran, GSK sales representatives specifically marketed Zofran as a morning sickness drug.

The promotion of Zofran for pregnant women eventually led to an investigation by the Justice Department. In July 2012, GSK agreed to plead guilty and pay a $3 billion settlement to resolve allegation of unlawful promotion of several drugs, including Zofran.


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