Defective Drugs: Zofran Birth Defect Litigation
Zofran and its genetic counterpart, ondansetron, is a prescription drug that was approved in 1991 by the U.S. Food and Drug Administration (FDA) to ease the nausea that cancer patients experience after chemotherapy treatment and surgery. Drug maker GlaxoSmithKline then began marketing the drug to doctors to prescribe to pregnant women who were suffering from severe nausea and vomiting from morning sickness. However, Zofran was never tested or approved for off-label use with pregnant women. Zofran has been linked to serious birth defects when used by pregnant women.
Which birth defects are commonly associated with Zofran?
Most morning sickness occurs in the first trimester of pregnancy, a vulnerable time for the fetus which is undergoing development. If the mother takes medication at this time that readily crosses the placenta it can do irreparable harm to the growing baby. A group of Danish doctors conducted a medical study investigating the link between Zofran and birth defects in 2013: it seems that a woman’s use of Zofran during pregnancy can increase the chances that she will give birth to a child with birth defects by 34%.
Some of the birth defects associated with Zofran use include:
- Cleft palate
- Cleft lip
- Heart murmur
- Atrial septal defect
- Skeletal malformations
- Spontaneous abortion
- Stillbirth
Zofran Litigation
In 2012 GlaxoSmithKline was ordered to pay a $3 billion settlement for illegally marketing Zofran for off-label, unapproved uses. Since then individuals have been filing claims for damages when they have given birth to children with birth defects after having taken Zofran in pregnancy. Lawsuits have also been filed alleging that GSK knew about the potential dangers associated with Zofran –perhaps as early as 1992 – and yet did not warn consumers about them. Furthermore, the manufacturers may have actively misrepresented the results of its studies.
Mothers who took Zofran during their pregnancy and then later gave birth to a child with birth defects may be entitled to file a claim against GlaxoSmithKline for negligence. Contact Bailey & Greer, PLLC to learn more about your options. We proudly serve families throughout Memphis, Jackson and West Tennessee.
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