Zofran is a common drug prescribed “off-label” to women to treat nausea and vomiting during pregnancy. However, with studies linking the medication to birth defects, many families are now filing lawsuits against the manufacturer. If you or a loved one has been adversely affected by the drug Zofran, our expert legal team at Goldberg & Rosen will help you recover the full and just compensation you deserve.
Zofran: Linked to Birth Defects
Manufactured by GlaxoSmithKline, Zofran is FDA-approved to treat nausea in cancer patients. It helps chemotherapy patients who vomit as a side effect of their treatment, as well as those who become sick after taking their medication. However, over time the manufacturer also began marketing the drug to pregnant women who suffered from morning sickness – despite the fact that the FDA never approved its use for these patients.
It’s estimated that as many as 80 percent of women suffer from nausea or vomiting during pregnancy. When it gets particularly severe, it can cause malnutrition and endanger both the mother and her unborn baby.
To treat this condition, physicians began prescribing Zofran. However, many babies born to mothers who took Zofran suffered severe birth defects such as:
- Heart defects
- Cleft lip
- Cleft palate
- Club foot
- Skull deformities
- Kidney defects
The increased risk for birth defects when pregnant women take Zofran is substantial. Some studies have found that Zofran during pregnancy doubles the risk of heart defects and leads to a 30% increased risk of birth defects overall.
An Overview of the Zofran Lawsuits
GlaxoSmithKline currently faces hundreds of lawsuits involving families whose babies were born with birth defects after their mothers were prescribed the drug Zofran. Court documents show that despite Glaxo knowing as early as 1992 that the drug posed an “unreasonable risk of harm” to developing babies, they continued to market the drug to pregnant women.
The Zofran lawsuits pose a number of serious allegations against GlaxoSmithKline, including that the manufacturer:
- Had a duty to ensure Zofran was safe before making it available.
- Marketed the drug as a safe way to treat morning sickness for pregnant women – despite the fact that the FDA had not approved its use for this purpose.
- Misrepresented animal studies suggesting that the drug was safe, when in reality the results demonstrated abnormal bone growth and signs of toxicity.
- Did not properly assess the safety of Zofran for use in pregnant women.
- Manufactured a defective and dangerous drug.
- Fraudulently claimed that the drug was safe for pregnant women.
Schedule A Consultation
If you or a loved one have been the victim of negligence or misconduct, please do not hesitate to contact among the best attorneys Miami has available at Goldberg & Rosen today to receive expert guidance about your legal options, as well as a free and confidential case evaluation.