W&L is now accepting cases of congenital heart defects and cleft facial abnormalities in children whose mothers during pregnancy took the prescription drug Zofran to relieve the symptoms of morning sickness.
Zofran — generic name ondansetron — has never been approved by the U.S. Food & Drug Administration (FDA) for treatment of morning sickness symptoms.
Further, medical studies have linked Zofran use during the first trimester of pregnancy to birth defects.
Approximately 1 million women take Zofran or ondansetron each year to relieve the symptoms of morning sickness, specifically nausea and vomiting.
Zofran has been FDA-approved for use by cancer patients to prevent nausea and vomiting side effects that can accompany chemotherapy, and the prevention of nausea and vomiting that can occur after an operation.
Zofran has not been approved by the FDA to prevent or treat morning sickness in pregnant women.
Zofran Maker Accused by U.S. Justice Dept.
In 2012, the manufacturer of Zofran — pharmaceutical giant GlaxoSmithKline — paid a fine of $1 billion as part of a settlement of claims brought by the U.S. Department of Justice.
The Justice Department claimed, among other things, that GlaxoSmithKline illegally promoted certain forms of Zofran for the treatment of morning sickness in pregnant women, and paid doctors to promote and prescribe Zofran.
Despite that settlement, GlaxoSmithKline still faces civil liability arising from claims by countless mothers who took Zofran during their pregnancies and gave birth to children with congenital defects, and from claims by afflicted children who are now adults whose mothers took Zofran during their pregnancies.
“We are accepting cases where the children of women who took Zofran in the first trimester of pregnancy were born with congenital heart defects,” said W&L’s Ellen Relkin, of counsel attorney.
“We are also accepting cases where the children of those who took Zofran were born with cleft lip, cleft palate or both,” Ms. Relkin added.
Contact Info for Zofran Birth Defect Victims
In addition to wanting to hear from mothers who took Zofran, W&L also expressed interest in talking to men and women born with one of these potentially Zofran-related birth defects who this year are between the ages of 18 and 24.
Zofran-related birth defect victims or their mothers who took Zofran during the first trimester of pregnancy can contact W&L for a no-cost, no-obligation discussion of their legal rights against GlaxoSmithKline.
There are two ways to arrange for this discussion. First, by completing and submitting the form located on this page. Second, by telephoning W&L at toll-free 800-476-6070.