Many women who took Zofran during pregnancy had no idea that it was prescribed off-label, or in other words it wasn’t approved by the FDA to treat morning sickness.
The majority of women who take Zofran only take it in the first trimester and only for a few days to alleviate nausea during early pregnancy. But morning sickness can be dangerous for a small percentage of women so they continue using the drug throughout their pregnancy.
One woman, Marquita Smiley, took it a few times a week into her second trimester, according to a news article published on June 1, 2016 in the Brimmingham News. During her 5th month of pregnancy an ultrasound showed her baby’s heart was underdeveloped. Just days after her son was born he had open-heart surgery and at two months of age he had a heart transplant. When Smiley say a an ad claiming that Zofran causes heart birth defects, she filed a lawsuit against the makers of Zofran. Smiley says if she had known of the risk of birth defects, “I would not have placed him at risk,” she told the newspaper.
Smiley lawsuit accuses the drug maker of marketing Zofran “off-label” as a safe and effective treatment for morning sickness. In fact, Zofran was often marketed as a “wonder drug” for pregnant women, despite having knowledge that the makers of Zofran had never once undertaken a single study establishing that this powerful drug was safe or effective for pregnant mother and their children.
More than 300 families have sued the makers of Zofran over birth defects they believe were caused by prenatal exposure to Zofran. Our law office continues to investigate Zofran claims from across the country. If you or a loved took Zofran while pregnant and the baby was born with birth defects, contact our office immediately.