Was your child born with a defect after you took Zofran (ondansetron)? You may be surprised to learn that the drug was never approved by the U.S. Food and Drug Administration (FDA) to treat morning sickness in pregnant women. In spite of this, drugmaker GlaxoSmithKline (GSK) marketed Zofran for this very purpose, prioritizing profits above the wellbeing of expectant mothers and their infants in a shocking display of negligence. Since then, multiple reports of serious fetal injuries resulting from Zofran use have been brought forward. For illegally promoting the drug’s “off-label” usage, GSK paid a $2 billion settlement in a civil lawsuit in 2012. This settlement did not include payments for damages suffered due to the use of Zofran. As Zofran birth defect victims, you and your child may be entitled to compensation for medical costs, emotional distress, loss of income, and other damages. The Wilshire Law Firm is currently accepting Zofran lawsuits. If you have any questions regarding your Zofran birth defect case, please don’t hesitate to contact us for answers. You can schedule a free, comprehensive consultation with one of our dedicated legal professionals by calling (800) 522-7274 or submitting an online contact form.
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Why Are Former Zofran Users Filing Lawsuits?
Although the FDA approved the use of Zofran only for the treatment of nausea and vomiting in cancer patients, GSK promoted the drug to physicians as a viable treatment option for pregnant women experiencing severe nausea. This would later prove ill-advised.
Several medical studies published in recent years have linked Zofran to the increased occurrence of major birth defects:
- In August 2013, a group of researchers compared outcomes among nearly 900,000 women who took Zofran during pregnancy between 1997-2010. They found that Zofran was associated with a doubled risk of heart defects, contributing to a 30 percent increased risk of birth defects overall.
- In December 2013, Australian researchers linked the use of Zofran in the first trimester with a non-significant 20 percent increased risk of birth defects.
- In December 2014, a study was published in Reproductive Toxicology that indicated a doubled risk of septal heart defects in infants whose mothers took Zofran during early pregnancy from 1998-2012.
Besides the aforementioned birth defects, Zofran use has also been linked to an increased risk of cleft lip, cleft palate, club foot, and craniosynostosis (skull deformities). These defects can render an infant forever dependent on their parents for care, resulting in enormous medical costs, mental anguish, and emotional distress.
Claims against GlaxoSmithKline
As early as 1992, GSK was aware that Zofran passes from mother to fetus through the placenta, presenting an unreasonable risk of harm to developing infants. Despite this knowledge, the drugmaker continued to market Zofran to pregnant women, making millions of dollars in the process.
GSK has committed multiple actions which constitute negligence and can be grounds for a lawsuit. Among them:
- They failed to ensure the drug’s safety and determine its risks before selling it to the public.
- They failed to warn the public about dangerous side effects.
- They marketed the drug as a safe treatment for morning sickness in pregnant women even if it was not approved by the FDA for this use.
- They produced a defective drug.
Do I Have a Zofran Lawsuit?
Reach out to the knowledgeable dangerous drug attorneys at Wilshire Law Firm to determine whether you have a viable Zofran lawsuit. Depending on the circumstances surrounding your case, you may have grounds to file a lawsuit based on the following arguments:
- You did not receive adequate warning about the dangers of Zofran
- You were misled by Zofran’s marketing about the dangers of Zofran
- The makers of Zofran neglected your well-being for the sake of profits
If you have taken Zofran during pregnancy and your child was born with a birth defect, you may have a very strong product liability claim against GSK. Please contact our lawyers immediately to find out more about your legal options in a free case consultation. You can call us at (800) 522-7274 to receive immediate assistance. You may also submit an online contact form and one of our dedicated legal staff will get back to you shortly.