The loss of a child is unfathomable and, in 1988, President Ronald Reagan proclaimed October as National Pregnancy and Infant Loss Awareness Month to recognize the loss, the event’s official website explains. The loss is intensified when the conditions that contributed to the child’s death were unnecessary and completely preventable. Such is the case for many families who have suffered the loss of a child due to in utero exposure to Zofran, which is manufactured by pharmaceutical giant GlaxoSmithKline (GSK).

Patrick and Valerie Reagan’s daughter, Molly, was just 3 days old when she died, the Consumer Justice Foundation says. The Reagans believe Molly’s fetal exposure to Zofran caused her birth defects that led to her death. Valerie was prescribed Zofran to help treat morning sickness while she was pregnant.

Similarly, Holly L. Estapa was also prescribed Zofran for the same condition during her pregnancy. She and Martin W. Hauger filed suit shortly after the birth of their twins, B.A. and B.B. One of the twins, B.A., was stillborn while the other twin B.B. was born with a heart defect that may require future surgeries, as well as monitoring and treatment. They also argue that the in utero exposure to Zofran was the cause of B.A.’s death and B.B.’s heart defect.

They are not alone.

The U.S. Judicial Panel on Multidistrict litigation reports that 415 lawsuits have been consolidated in the Zofran multidistrict litigation (MDL) established in the U.S. District for the District of Massachusetts. Beasley Allen has previously explained that the underlying claim is that Zofran causes birth defects in babies born to women who used the drug while pregnant. Often, women are not told of the potential dangers Zofran presents to their unborn children.

The Food and Drug Administration approved Zofran, which contains the drug ingredient ondansetron, in 1991 to treat nausea and vomiting in cancer patients receiving chemotherapy. It has never been approved to treat morning sickness, yet GSK’s profits from Zofran alone were more than $1 billion because of the prevalent off-label use to treat morning sickness during pregnancy.

In 2012, the U.S. Department of Justice (DOJ) claimed GSK directly marketed Zofran to obstetricians and gynecologists with unsupported claims about its safety during pregnancy, according to the Legal Herald. Although it is legal for doctors to prescribe drugs for off-label use, it is not legal for drugmakers to market drugs for such uses. The company also paid illegal kickbacks to doctors, encouraging the doctors to promote and prescribe Zofran more frequently, according to the DOJ. GSK pled guilty and agreed to pay $3 billion to settle criminal and civil fraud charges for illegal promotion of Zofran and other drugs.

Zofran is now available as an inexpensive generic and continues to be prescribed regularly for pregnant women suffering from morning sickness. Recent studies have linked in utero exposure to Zofran with an increased risk of birth defects. Two studies have shown a doubling of the risk of certain congenital heart defects in babies whose mothers took Zofran early in pregnancy. A third study showed a doubling of the risk of cleft palate for babies whose mothers took Zofran.

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Lawyers in our firm’s Mass Torts Section continue to investigate cases involving children born with a heart defect or cleft palate after in utero exposure to Zofran. If you would like more information about this litigation, or if you or someone you know has had a family member who suffered from a congenital heart defect or cleft palate as a result of prenatal Zofran exposure, contact Roger Smith or Liz Eiland, lawyers in our firm’s Mass Torts Section, at 800-898-2034 or by email at or

Sources: Remembering our Babies
Consumer Justice Foundation
U.S. Judicial Panel on Multidistrict Litigation
Beasley Allen
Legal Herald
Jere Beasley Report (March 2016)

Liz Eiland, Beasley Allen Attorney
Elizabeth A. Eiland

Liz handles cases involving Zofran and proton pump inhibitors (PPIs).

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