Zofran Lawsuit Information

Mothers are filing Zofran lawsuits against GlaxoSmithKline after they gave birth to a child affected by malformations. This antiemetic drug was only approved by the FDA to prevent nausea and vomiting caused by cancer chemotherapy and surgical interventions. However, GlaxoSmithKline widely marketed it for a whole decade as an off-label treatment for morning sickness in pregnant women.

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Zofran during pregnancy exposes your babies to its dangerous effects, causing severe fetal malformations. If your baby was born with a birth defect you might be eligible for a large cash settlement by filing a lawsuit. Call right now at 8004301673 or click here to speak to one of the best Zofran lawyers that will help evaluate your legal options for free.

The use of this drug as an off-label medication during pregnancy has been determined to be illegal and unreasonably dangerous. Ondansetron can also cause several other dangerous side effects such as Serotonin Syndrome and Arrhythmias (Abnormal Heart Rhythm) in specific circumstances.

Dangerous Side Effects

If you gave birth to a baby with any malformation after taking Zofran during pregnancy, you need to file a lawsuit. Possible complications may include:

Heart Defects

Kidney Malformations


Cleft Lip and Cleft Palate

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Why should you file a Zofran lawsuit against GlaxoSmithKline?

Court documents presented during the 2012 trial against Glaxo allegedly showed that the pharmaceutical company knew about the dangers of using ondansetron in pregnant women as early as 1992. Many clinical trials performed by the company showed evidence of congenital malformations in animals injected with the drug. However, Glaxo ignored these risks and kept selling their medication to pregnant women claiming it was safe. The Big Pharma didn’t care that the U.S. Food and Drugs Administration (FDA) never granted approval to any form of this medicine for this indication either, and widely advertised it across the country. GlaxoSmithKline made billions out of this drug and even paid kickbacks to convince doctors and other health care providers that prescribing their branded version as an off-label treatment for morning sickness was a good idea. Other companies such as those who manufacture the generic ondansetron drugs or the oral dissolving tablets Zuplenz never knew about the risks since GSK concealed all the studies. At least 1 million women each year keep taking this drug still today, despite the risks for their fetus and for their own health.

The reasons why Zofran attorneys brought Glaxo before the court

The pharmaceutical company is formally accused of several illegal behaviors including:

  • Releasing an unsafe drug to the public, even though it’s its precise responsibility to determine a medication’s safety as well as its effectiveness.
  • The company never warned the public about the dangers of using this drug in pregnant women.
  • Concealing the clinical studies that proved that this medicine is unsafe in gestating women, making up deliberately false claims about its safety.
  • Misrepresenting many animal studies possessed by the company whose results showed that their drug may cause birth defects.
  • Marketing this medication as an off-label treatment for morning sickness without FDA’s approval.
  • Negligence in properly evaluating data on this medication’s safety for in specific populations of patients (such as expectant mothers)

Zofran Indication

Ondansetron is an antiemetic drug. Meaning, its mechanism of action prevents the sensation of sickness or nausea by acting directly on the brain. For this reason, it is widely regarded as one of the most potent medication to prevent and treat nausea and vomiting caused by surgical interventions, as well as cancer chemotherapy and radiotherapy.

The off-label prescription scandal

Thanks to its superior effectiveness, this medicine gained a widespread success among patients, so GlaxoSmithKline decided to market it as an off-label treatment for “lesser” forms of nausea such as morning sickness during pregnancy. However, the FDA never fully evaluated its safety on expectant mothers and never gave authorization for this use. Several studies pointed that using ondansetron during gestation was dangerous, not only because it can cause congenital malformations, but also because of its risk of cardiovascular disorders. Women who suffer from the most extreme of nausea and vomiting during pregnancy (NVP), a condition called hyperemesis gravidarum, are in fact exposed to electrolyte imbalances which may trigger lethal arrhythmias when under treatment with this antiemetic.

GSK ignored the warning

When Zofran’s patent ended in in 2006, Novartis and its subsidiary Sandoz that began producing the generic version Ondansetron, kept marketing it to women as a safe drug. However, the promotion of this medication for its off-label uses was later considered illegal. In 2012, GSK was brought to court by the U.S. Department of Justice (DOJ), who accused the pharmaceutical company of fraud and illegal promotion of the antiemetic together with other drugs. The manufacturer eventually pleaded guilty to federal charges and agreed to pay $3 billion to settle down the accusations.

Many families are bringing their cases to court seeking for just compensation for all the damage suffered. GSK illegally and fraudulently overstated this medicine’s safety. For this reason, plaintiffs are now defending their right to receive a monetary award to repay all medical expenses as well as the emotional hardships they had to face.

The scientific evidence brought in court by lawyers

Using this powerful antiemetic during gestation is associated with many personal risks for the mother and her baby. Once absorbed, the molecule is able to cross the human placenta and reach the fetus in a significant amount. As the baby requires a much longer time than the mother to flush this drug out of his body, it keeps accumulating reaching a much higher toxic potential.

Several studies brought to court by the plaintiffs and their attorneys showed case documentation published over the course of the last 20 years. These exhibits thoroughly demonstrated that Zofran increased the risk of congenital defects by at least 30%. Some of the most severe malformations require surgical correction after the baby is born, while others cause permanent damage or even fetal death while still inside the womb. A study published in the American Journal of Obstetrics and Gynecology showed that this danger is even higher when the antiemetic is taken during the first three months of pregnancy.

The Multidistrict Litigation Number 2657

Since the number of Zofran lawsuits filed against Glaxo is growing steadily, they have been centralized into a Multidistrict Litigation under Judge F. Dennis Saylor in the District of Massachusetts (MDL No. 2657). Over 200 cases have been filed so far by plaintiffs who blame the pharmaceutical company for the injuries suffered by infants born after their mothers took the antiemetic drug during pregnancy. Massachusetts is the same district where the pharmaceutical company already faced their accusations of criminal fraud during the federal trial held back in 2012. GSK plead guilty and paid $3 million to settle down the accusation it faced.

LeClair v. GlaxoSmithKline

One of the first litigations filed against GlaxoSmithKline was Tomisha LeClair’s one. The woman from Massachusetts filed her dispute in February 2015 claiming the pharmaceutical company was liable for the damage suffered by her child. The plaintiff took this drug to treat her severe NVP that prevented her from working and performing day-to-day activities. However, due to the lack of adequate warnings, she was completely unaware of the potential dangers. Sadly, her daughter A.S. suffered from many malformations after she was born, requiring her to endure 10 surgical interventions in 12 years to correct the abnormalities. Some of the birth defects suffered by A.S. included: heart defects, inguinal hernia, low set ears, facial dysmorphia, photophobia, hearing loss and webbed toes.

LeClair claims in her lawsuit that if GSK provided enough information about the antiemetic drug risks, she would never have taken it while expecting her daughter. Her lawyers are now asking for compensation for all the medical expenses she had to sustain, as well as punitive damage to hold the pharmaceutical company accountable for its negligence in providing truthful information about the medication’s safety. All around the United States, Zofran attorneys are stacking up new cases even if the legal proceedings are in the early stages. If you think you deserve a compensation for the injury you suffered, let us help you find the best attorney available to fight for your rights in court.