Zofran Lawsuit Attorney in Columbia
The large amounts of chemicals cancer patients take in during chemotherapy and radiation treatments typically cause acute nausea and vomiting. Many patients find the nausea agonizing. Doctors prescribe these patients several medications for chemotherapy-related nausea – one of which is Zofran.
Zofran (ondansetron) hit the pharmaceutical market as a prescription drug to prevent nausea and vomiting for patients undergoing surgery or cancer treatments. For use against medically-induced nausea, it has been very effective and is a popular choice in hospitals around the nation, along with sister drug Zuplenz and generic versions of ondansetron. Unfortunately, Zofran’s manufacturer, GlaxoSmithKline, began marketing the drug to pregnant women without the U.S. Food and Drug Administration’s (FDA’s) approval. Now, women are taking the company to court after studies linked Zofran to birth defects.
Zofran and Birth Defects
The FDA never approved Zofran for women battling morning sickness during pregnancy, yet many doctors began prescribing the drug to pregnant women after GlaxoSmithKline marketed it for this purpose. In 2012, GlaxoSmithKline pled guilty to fraud and illegal promotion of several drugs, including Zofran, in a $3 billion lawsuit. According to court documents, GlaxoSmithKline knew as far back as 1992 that Zofran presented a risk to developing fetuses. It passes through the placenta, posing the risk of birth defects.
Since the drug passes through the placenta, developing fetuses are exposed to the drug. The birth defects families have mentioned in court range from heart defects to skull deformities. Women took Zofran during pregnancy under the belief that it would solve severe morning sickness and prevent complications. In reality, it caused birth defects that rendered many babies forever unable to live on their own. Research associates congenital birth defects with the drug, and some of these include:
- Septal defects (holes) in the heart
- Cleft lip
- Cleft palate
- Webbed toes
- Club foot
- Hearing loss
- Facial dysmorphia
- Skull deformities (“craniosynostosis”)
The FDA linked Zofran to serotonin syndrome in 2013, which can lead to rapid heartbeat, muscle rigidity, high fever, and loss of consciousness in pregnant women. The FDA also warned the public of irregular heart rhythms connected to intravenous doses of Zofran. Despite these warnings, the FDA has not stopped doctors from prescribing the drug to pregnant women.
Currently, the FDA classifies Zofran as a “Pregnancy Category B” drug. This means no studies have confirmed the drug to cause birth defects. Doctors everywhere are still prescribing Zofran to pregnant women despite ongoing lawsuits.
Current GlaxoSmithKline Lawsuits
The families of babies born with severe physical and mental birth defects after the mother took Zofran and other versions of ondansetron during pregnancy continue to file product liability lawsuits against the company today. The claims against GlaxoSmithKline in court include that the company:
- Produced a defective drug.
- Failed to properly evaluate the safety of Zofran for pregnant women.
- Failed to warn users about dangerous side effects.
- Illegally advertised Zofran as a safe medication for morning sickness.
There are currently hundreds of pending Zofran lawsuits. As scientists continue to conduct more studies regarding Zofran and birth defects, new evidence may come to light. Speak with a lawyer if you believe Zofran, Zuplenz, or a related drug caused your child’s congenital birth defects. You may be eligible to receive compensation.
Need Legal Advice Concerning Zofran in Columbia?
Many studies have already linked Zofran and generic forms of ondansetron with birth defects, improving your chances of getting the recovery you deserve. If GlaxoSmithKline’s negligence affected you or your child’s life, don’t hesitate to talk to Columbia, MD attorneys about your case. Call 888.838.3978 today to get in touch with Discepolo LLP, or contact us online. We have extensive knowledge about medical malpractice, product liability, and defective drugs, and we can help you learn your options for filing a claim.