Zofran Birth Defect Lawsuits Being Filed NowMorning Sickness Drug Linked To Serious Birth Injury
- July 26, 2015
- Defective Drugs, Uncategorized, Zofran
- Posted by Darren Miller
- Comments Off on Zofran Birth Defect Lawsuits Being Filed Now
Even though the first case has yet to be heard, more and more women are filing Zofran birth defect lawsuits in federal courts. For example, one mother who was prescribed Zofran to treat her morning sickness recently filed a claim because her son was born with serious heart defects which required surgeries to correct. These women were given a drug that wasn’t FDA approved for use in pregnant women.
Zofran Involved In Largest US Health Care Fraud
In 2012, GlaxoSmithKline (GSK) was ordered to pay $3 billion in 3 False Claims Act settlements. This became the largest health care fraud award in the US. It was alleged that the pharma company had illegally promoted some of their best selling drugs, including Zofran, for off-label use. They were accused of paying doctors to prescribe their medications and of falsely representing the safety of these drugs.
Zofran, was approved by the FDA to treat nausea and vomiting after surgery or cancer treatment. However, Zofran manufacturer, GSK has pushed the drug for off-label use by pregnant women to treat symptoms of morning sickness. Unfortunately, the drug may not have been tested adequately to determine to risk to an unborn fetus.
GSK made millions by marketing Zofran as safe to treat morning sickness. Off-label prescribing is a common and legal practice among the medical community. This means that a certain drug may be used in a way not specified by the FDA approved label if your doctor feels that it will be beneficial in your situation. However, the doctor relies on the drug manufacturer to have represented the drug correctly in order to make a determination on whether this is the best case scenario for their patient.
Numerous studies link the use of Zofran during pregnancy to possible serious risks to the fetus. One study, published in 2014 complied data from the Swedish Medical Birth Register with the Swedish Register of Prescribed Drugs. Of the 1349 infants born to women that had used Zofran during their first trimester, a significantly increased risk of cardiovascular defects, particularly cardiac septum defect were detected. Other studies have indicated possible risks of cleft lip and palate.
Zofran Lawsuits Are Being Filed In Federal Courts
In spite of the studies and without FDA approval, GSK had failed to add a warning against prescribing Zofran to pregnant women. As a result, babies may have been harmed by a drug marketed as safe for use off-label to treat morning sickness. If you were given Zofran to treat nausea or vomiting during your pregnancy and your infant was born with certain birth defects, you are encouraged to contact us now to add your claim to the many currently being filed.