Lawyers for Zofran Birth Defects, Malformations
The birth defect lawyers at Saiontz & Kirk, P.A. are reviewing potential claims for families of children born with severe health problems or congenital malformations that may have been caused by the prescription of Zofran during pregnancy for morning sickness, nausea or vomiting.
As a result of the drug maker’s failure to warn about the potential pregnancy side effects of Zofran, many children may have experienced severe and potentially life-threatening birth defects and congenital malformations, including:
Financial compensation may be available through a Zofran lawsuit, as many of these severe health problems could have been avoided if GlaxoSmithKline had properly researched the pregnancy risks associated with the medication and warned about use of off-label Zofran for morning sickness.
There are no fees or expenses unless a recovery is obtained for a birth injury from Zofran. To review a potential claim for your child or a loved one, request a free consultation and claim evaluation.
Birth Defects and Zofran Problems
Zofran (ondansetron) is an anti-nausea and vomiting medication that was introduced by GlaxoSmithKline in 1991.
While the medication is only approved for treatment of nausea and vomiting symptoms among chemotherapy patients and following surgery, it has been widely used “off-label” as a morning sickness drug.
Nausea and vomiting during the first trimester of pregnancy is one of the most common symptoms experienced by pregnant women.
In rare cases, extreme morning sickness can result in hyperemesis gravidarum, which may result in hospitalization, dehydration, malnutrition, fluid or electrolyte imbalances, and other complications.
Despite a lack of evidence establishing Zofran was safe for pregnant women, lawsuits allege that GlaxoSmithKline actively promoted such off-label use and withheld important warnings about the potential link between Zofran and birth defects.
Zofran warnings indicate it is a “Pregnancy Category B” drug, meaning that animal studies have not found evidence of risk. However, evidence suggests that the medication should be categorized as a Category D or X medication.
Unborn babies exposed to Zofran during pregnancy face an increased risk of serious health problems, including heart defects, cleft palate/lip and other congenital malformations.
Learn More About Zofran Pregnancy Studies
Zofran Settlement for Illegal Marketing
While doctors are permitted to prescribe Zofran for morning sickness in pregnant women, it is illegal for the GlaxoSmithKline to promote such off-label use, since the drug maker failed to conduct adequate studies to establish that it is effective among pregnant women or safe for unborn babies exposed during pregnancy.
Lawsuits allege that GlaxoSmithKline knew or should have known for years that Zofran was not safe for pregnant women, and that there was a lack of evidence concerning the potential risk of birth defects or health problems. However, the drug maker has placed their desire for profits before consumer safety by reckless promoting and encouraging the off-label use of Zofran for morning sickness, while withholding information about the risk of birth defects.
In 2012, GlaxoSmithKline agreed to pay $3 billion to settle a criminal investigation stemming from the off-label promotion for pregnancy use of Zofran, as well as other illegal drug marketing and withholding safety data from U.S. regulators. The U.S. Department of Justice described the agreement as the “largest health-care fraud settlement in U.S. history.”
Among allegations brought by the U.S. Government, GlaxoSmithKline knowingly promoted the off-label use of Zofran during pregnancy, even though the FDA had not established that it was safe for the fetus. The drug maker also allegedly offered and paid illegal kickbacks to medical providers in an effort to encourage them to prescribe Zofran to pregnant women.
The Department of Justice agreement (PDF) reached with GlaxoSmithKline included a Zofran settlement, in which $2.3 million of the money repaid to the U.S. government and state Medicaid programs was allocated for false or fraudulent claims involving Zofran. In addition, another $54.6 million of the settlement was allocated for kickbacks paid to encourage off-label use of Zofran and other drugs.
Zofran Birth Defect Lawsuit Allegations
- Failure to warn about Zofran birth defects;
- Failure to study Zofran pregnancy risks;
- Misrepresenting the safety of Zofran for morning sickness;
- Illegally marketing Zofran for use by pregnant women;
Zofran Class Action Lawyers
As a result of GlaxoSmithKline’s decision to illegally market their drug while withholding important warnings about the link between Zofran and birth defects, substantial revenue has been generated at the expense of unborn children.
Prior to the availability of generic Zofran in December 2006, the medication was the 20th best-selling drug in the United States, generating $1.3 billion in sales during the first three-quarters of 2006.
According to FDA briefing materials (PDF) released in 2006, OB/GYN’s were the most frequent prescribers associated with the drug, suggesting that off-label Zofran pregnancy use may have accounted for approximately 23% of all dispensed prescriptions at that time.
The product liability lawyers at Saiontz & Kirk, P.A. are reviewing potential Zofran class action lawsuits and individual Zofran birth defect cases for families of children throughout the United States who have been born with:
- Heart Defects (including a Atrial Septal Defect, heart murmur, etc.)
- Cleft Lip or Cleft Palate
- Kidney Defects
- Wrongful Death
All lawsuits are handled by our Zofran lawyers on a contingency fee basis, which means that there are no out-of-pocket expenses to hire our law firm and we receive no attorney fees or expenses unless compensation is received for a baby injured by Zofran.
It is important that families review any potential Zofran claim for their child as early as possible, as every claim does have a statute of limitations, or deadline which requires that any lawsuit be filed by a certain date.