Zofran, also known as Ondansetron, was developed in 1991 by GlaxoSmithKline laboratories. The drug was approved for use in chemotherapy and post-surgery patients experiencing nausea. First used intravenously, changes were made to the formula over time to make a more convenient form. In 1999, the FDA approved the pill form of Zofran, and in 2006, a generic form was released.
Zofran’s Link to Birth Defects May Lead to Class Action Lawsuit
After the generic form was released, Zofran quickly became one of the most prescribed drugs in America for nausea, specifically in pregnant women. The drug effectively blocks feelings of nausea and suppresses the urge to vomit. Unfortunately, the drug was never FDA approved for use in people other than those undergoing chemotherapy treatments, and side effects have been severe. Currently, several class action lawsuits are being investigated in the off-label use of Zofran and its high risk of causing birth defects, like cleft lip and palate.
The FDA, who found GlaxoSmithKline to be promoting Zofran to doctors for off-label use, filed the first lawsuit in 2012. According to the FDA, GlaxoSmithKline knew the risk of these side effects and continued to promote the drug anyway. The lawsuit settled for $3 billion, but pregnant women who suffered because of this medication were not compensated.
A Class Action Lawsuit May Be Warranted
Currently, our firm is investigating cases to bring forth a class action lawsuit against GlaxoSmithKline. We believe women who were prescribed this drug and experienced side effects, or gave birth to a child with a birth defect, should be compensated for their suffering. Since 2012, multiple lawsuits have been filed against GSK for the following claims:
- GSK failed to determine safety risks before selling and marketing the drug to the public.
- GSK failed to warn the public about the known dangerous side effects.
- GSK advertised the drug as safe for morning sickness when the drug was not approved for such use.
- GSK misrepresented animal studies suggesting the drug was safe. In fact, these studies showed abnormal bone growths and toxicity related to the drug.
- GSK failed to evaluate data and safety information pertaining to Zofran’s use in pregnant women.
- GSK produced a defective drug.
- GSK fraudulently claimed that the drug was safe to use with pregnant women.
A successful lawsuit will compensate for the plaintiff’s past and future medical bills, pain and suffering, and in-home care. If you have taken Zofran and have experienced side effects yourself, or have given birth to a child with birth defects, contact our office today. Our experienced attorneys are standing by to provide you with legal options.
What a Class Action Lawsuit Means in the Zofran Case
Our firm is currently seeking to bring forth a class action lawsuit against the pharmaceutical company GlaxoSmithKline (GSK) for its promotion of off-label use of the drug Zofran. Zofran was originally developed in 1991 and was FDA approved for use in chemotherapy and post surgery patients experiencing nausea. The drug was made in generic form in 2006, and it quickly became the most commonly prescribed drug for treating morning sickness in pregnant women.
While the drug was highly effective at treating nausea, it has been linked to a host of extremely dangerous side effects and birth defects, including Serotonin Syndrome in the mother, and congenital heart defects and cleft lip or palate in the child. In 2012, the FDA filed a civil lawsuit against GSK, and the pharmaceutical giant pled guilty to failure to disclose harmful side effects and unlawfully promoting off-label use of Zofran. Subsequently, GSK paid over $3 billion in recovery charges, though the women who took this drug received no compensation.
Zofran is still prescribed to over one million women annually, and reports of side effects and birth defects continue to be filed. Several studies linked Zofran to a handful of birth defects, including a 2012 study, which showed a 2.4 increase in risk of giving birth to a baby with a cleft palate. Another study showed a 30% increase in overall birth defects, and a 2014 study linked Zofran to a doubled risk of congenital heart defects. Birth defects that have been commonly linked to this drug are as follows:
- Musculoskeletal anomalies
- Cleft Lip, Cleft Palate, or both
- Heart defects, including holes in the heart, heart murmur, and septal defects
FDA Research is ongoing and continues to find correlations between the drug and maternal side effects like irregular heartbeat, difficulty breathing, rashes, and dizziness or fainting. Additionally, a high risk of Serotonin Syndrome is indicated, which causes cognitive and behavioral changes and can lead to coma or even death. If you have taken Zofran in the past and have either suffered side effects or have given birth to a child with a birth defect, contact our firm today to explore your legal options in filing a class action lawsuit.