February 19, 2015 — GlaxoSmithKline (GSK) has been hit with a lawsuit from a woman in Massachusetts who blames Zofran for her daughter’s birth defects.
The woman, Tomisha LeClair, filed the lawsuit on behalf of her daughter, A.S., who was born in 2000 with birth defects. LeClair took Zofran to treat morning sickness during her first trimester of pregnancy.
A.S. was born with several heart defects, including a “hole in the heart” (atrial septal defect), right ventricular hypertension, and aortic arch hypoplasia. She also had facial dysmorphia, low set ears, hearing loss, sensitivity to light, ingueno hernia, and webbed toes.
The lawsuit was filed on February 16 in the U.S. District Court for the District of Massachusetts.
According to the lawsuit (PDF):
“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.”
Attorneys for the LeClair family claim GSK knew that Zofran could cross the placenta based on animal studies from the 1980s. More recent studies have confirmed that Zofran also crosses the human placenta.
Between 1992 and today, GSK has allegedly received over 200 reports of birth defects in children exposed to Zofran. In addition, at least four large-scale epidemiological studies have found evidence that Zofran increases the risk of birth defects, especially heart defects.
However, instead of updating warnings, GSK instructed sales representatives to market Zofran as a treatment for morning sickness. This “off-label” marketing eventually caught the attention of the Justice Department. In July 2012, GSK paid a $3 billion settlement for illegally marketing several drugs, including Zofran to pregnant women.