Zofran® is a popular anti-nausea medication originally intended for use with cancer patients undergoing the chemotherapy process. In recent years, however, doctors have prescribed this medication in increasing numbers to pregnant women in order to combat morning sickness. Children born to mothers who have taken this drug while pregnant face risks in terms of developing congenital heart defects or cleft palate.
The Goldwater Law Firm understands the challenges you may be facing as a parent going through this nightmare and we are here to help. If you or someone you know has given birth to a child with birth defects after taking Zofran® while pregnant, you may have rights to file a Zofran® lawsuit.
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History of Zofran®
Although the U.S. Food and Drug Administration initially approved Zofran® to treat cancer patients suffering from nausea after treatments or surgery, it has been used to help pregnant women suffering from morning sickness as well.
Court documents indicate that the company manufacturing Zofran®, GlaxoSmithKline, knew as early as 1992 that there was unreasonable risk of harm for developing babies because the drug passes through the human placenta while in the mother’s body. Lawsuits against the manufacturer argue that the drug maker continued to market this drug to pregnant women despite knowing this, putting women and their children at risk. Sadly, too many women learned about these risks too late after their children were born with serious birth defects.
Other claims listed in the lawsuit include arguments that Glaxo had a duty to ensure the drug was safe before putting it on the market, that the company failed to warn the public about the dangerous side effects that could influence children, that Glaxo advertised the drug as a safe treatment for morning sickness even though it was not necessarily approved for this use, that the company failed to properly evaluate all testing and safety information about Zofran® for use in pregnant women, that the drug produced was a defective one, and that the manufacturer fraudulently and falsely claimed that Zofran® was safe for pregnant women to use. No version of Zofran® is currently recommended for use with pregnant women.
Lawsuits accuse the manufacturer of marketing this drug to pregnant women as well as encouraging doctors to prescribe it. While this drug brought in millions of dollars for the manufacturer, the women and children are the ones paying the price as a result of birth defects.
Although 80% of women suffer some kind of vomiting or nausea during pregnancy, in the most severe form, a mother may seek medical advice on how to deal with the morning sickness. Many women turned to Zofran® or other versions of the drug to keep them safe from complications that were associated with other medications.
Unfortunately, however, when these children were born with cleft palate or other birth defects, mothers began to realize that Zofran® may not be as safe as advertised.
In 2012, the Department of Justice filed civil and criminal claims against manufacturer GlaxoSmithKline. This lead to the biggest health care fraud settlement in American history after the company agreed to pay out $3 billion in damages.
The medicine was promoted for use in treating nausea and pregnant women despite lack of FDA approval to do so. The law suit also alleged that the drug manufacturer paid kickbacks to doctors or other health care providers in order to promote the prescribing of Zofran®.
Why to Contact a Zofran® Lawyer
If you or someone you know has been injured by this drug or if you believe that your child’s birth defects may have been influenced by taking Zofran® while you were pregnant, you may have recourse to file a Zofran® lawsuit. The Goldwater Law Firm knows that it can be challenging to move forward with a case like this but we remain committed to your best interest and fighting for the best possible outcome. Get legal advice as soon as possible so that you can initiate the path towards recovering compensation. To schedule a consultation with one of our practicing attorneys, please give us a call or complete our inquiry contact form