What is it?
Zofran is a drug manufactured by pharmaceutical company GlaxoSmithKline and used for the nausea symptoms associated with cancer treatment, or surgery. It was approved for such use in 1991 and generic versions of it were approved in 2006. Since this drug has been on the market, Glaxo has made hundreds of millions of dollars each year from its use. A large percentage of these sales are from doctors prescribing the medication to pregnant women looking for relief from morning sickness. 80% of pregnant women experience pregnancy related nausea and one million in the U.S. alone used Zofran. These women were prescribed the drug from their doctors even though it has never been approved for such use. Zofran, when taken during pregnancy increases the risk of birth defects by 30% and increases the risk of heart conditions. Glaxo paid health care professionals to promote the use of Zofran to expectant mothers and made false representations about he safety of their product.
What Happens to Pregnant Women and Their Babies?
If an expectant mother takes Zofran she can suffer a variety of side effects such as: rashes, hives, and itching, shortness of breath, body swelling, constipation, irregular heartbeat, dizziness, fainting, difficulties in breathing and swallowing, blurred vision, temporary vision loss, slow heart rate, anxiety, shivering, light headedness, changes in urination. Most of these conditions are temporary and end shortly after the medication is stopped.
The permanent damage is that which is done to the child. An infant that is born to a woman who took Zofran during pregnancy is three times as likely to be born with a serious life-altering defect. Some of those include:
Who is Responsible?
In 2012 Glaxo pled guilty to fraud and illegal promotion of several drugs, including Zofran. It was found guilty for illegal marketing when they promoted the sale and unsafe use of Zofran for conditions other than that which was FDA approved. Glaxo never conducted studies as to the effects on pregnant women and fetuses but knew as early as 1992 that Zofran presented an unreasonable risk of harm. Between 1992 and today there were over 200 reports of birth defects in children exposed to Zofran in utero. Despite this knowledge, they continued to market and distribute to pregnant women and their unborn children.
Where Do I Go Now?
If you or a loved one used Zofran during pregnancy and suffered negative complications you may be entitled to compensation to help relieve your family and provide your child future care. When Glaxo knowingly manufactured an unsafe product and marketed it while failing to warn the public, patients were prevented from taking steps to protect themselves. Taking legal action protects not only yourself and your loved one, but also sends a message that this type of behavior is not acceptable. Call the Hershewe Law Firm at 417-999-9999 or contact us for a free consultation to find out if you have a case.