For more information or confidential assistance
Call 800-306-3180

Zofran Lawsuit Alleges Heart Defects, Death of Newborn

pregnant womanParents have filed a Zofran heart defects lawsuit in Ohio against GlaxoSmithKline, alleging use of their anti-nausea drug during pregnancy led to the severe heart defects and subsequent death of their daughter.

The plaintiffs are seeking damages from the pharmaceutical giant, stating the company failed to provide proper warning about the risks associated with their drug during the early weeks of pregnancy.

Pregnancy with first child ends in tragedy

According to the complaint, the mother plaintiff was pregnant with her first child in 2005 when she went to see her physician with complaints of extreme nausea. Her doctor prescribed Zofran for her morning sickness, which the mother plaintiff took as prescribed. Her pregnancy proceeded without incident until nine days before her delivery. At that time, decelerations in the baby’s heart rate were noted.

When the mother plaintiff delivered her baby girl on March 17, 2006, she was diagnosed with a right ventrical heart defect. Although she was placed immediately into NICU, the baby crashed when she was three days old and physicians were not able to revive her. The baby died on March 20, 2006.

Since the loss of their firstborn child, the parent plaintiffs have poured time and money into awareness of heart defects like their daughters. More recently, the parents have discovered the possible link between Zofran use by mothers during the early weeks of pregnancy and congenital birth defects in their children. Following that realization, the parent plaintiffs filed their lawsuit against GlaxoSmithKline, claiming the company should have been aware of the dangers of their drug and provided proper warning about those dangers to members of the medical community and the general public.

About Zofran

Zofran was approved by the FDA in 1991 for the treatment of nausea and vomiting during chemotherapy. Although the drug has never been approved for use during pregnancy, this complaint asserts that GlaxoSmithKline actively markets Zofran for the treatment of morning sickness. Since morning sickness commonly occurs during the early stages of pregnancy, the drug is often prescribed during those weeks when the fetus is undergoing significant development.

Concerns about the association between Zofran use during pregnancy and birth defects have been growing, however. In Canada, 20 women have reported serious side effects in their children, according to the Toronto Star. Two of those cases resulted in infant death, while numerous others reported heart and kidney malformations. The FDA has also received two reports of fetal death associated with Zofran use.

In 2013, a Danish study involving more than 2,000 pregnant women between 2004 and 2011 found no correlation between Zofran use and birth defects. Later that year, another group of Danish researchers used the same data from the original study, but expanded the period of research to between 1997 and 2010. The new analysis also involved many more pregnant women – nearly 900,000. This analysis found a twofold increase in congenital heart defects when Zofran was taken during the first trimester of pregnancy.

In this Zofran lawsuit, the parents are demanding damages from GlaxoSmithKline in excess of $75,000 to compensate them for pain and suffering, medical bills and other non-economic losses. The couple is also seeking punitive damages from the pharmaceutical company, stating GlaxoSmithKline’s actions in this matter were “willful and malicious.”

  1. Ob.Gyn.News, Ondansetron: New and Troubling Data,

  2. Toronto Star, Birth Defects Blamed on Unapproved Morning Sickness Treatment,

  3. PubMed, Use of Ondansetron during Pregnancy and Congenital Malformations I the Infant,