A woman has filed a lawsuit against the makers of Zofran alleging that the anti-nausea drug caused her 2 children to be born with atrial septal defects, a congenital malformation that occurs when there is a hole in the wall between the heart’s upper chambers.
Free Zofran Lawsuit Evaluation: If your child or other loved one was born with a birth defect after the mother took Zofran during pregnancy, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of Zofran and our lawyers can help.
Lawsuit Alleges Zofran Caused Heart Defects
The lawsuit was filed on behalf of Cheryl Flynn, who claims she didn’t suspect that Zofran (generic: ondansetron) was the cause of her children’s atrial septal defects, having never been warned until recently that the anti-nausea drug had never been approved to treat morning sickness.
Flynn’s family has no prior history of congenital defects, genetic malformations or other risk factors that would have increased the likelihood that her children would be born with the same heart defect, according to the lawsuit. However, after taking Zofran during the first trimester of pregnancy, the woman gave birth to 2 babies – one in 2004 and the other in 2006 – with atrial septal defects.
As a result of these problems, the first child failed to thrive physically and lagged in the 5th percentile for her age group. In 2011, she was forced to undergo heart surgery in an attempt to repair the defect, what the complaint refers to as a “hole in the heart.”
Flynn’s second baby was born prematurely. This child also had a heart defect and required around the clock monitoring to ensure her oxygen levels were appropriate. As a result, she also suffered from significant developmental delays. According to the complaint, the baby “was unable to breathe adequately [after birth] and required 24-hour monitoring with an electronic alarm that would alert her parents and caregivers that her oxygen levels were dangerously low.”
Plaintiff Claims GSK Illegally Marketed Zofran as Morning Sickness Treatment
Although GSK has never conducted clinical trials to test Zofran’s safety during pregnancy, Flynn alleges the company “marketed Zofran ‘off-label’ as a safe and effective treatment” for morning sickness. Under U.S. law, pharmaceutical manufacturers are not allowed to promote medications for any uses the FDA has not approved them for. Indeed, the plaintiff referenced federal charges filed against GSK in 2012, many of which involved “off-label” promotion of Zofran and other drugs. In her complaint, Flynn alleges:
“At or around the same time, GSK also entered civil settlements with United States that included more than $1 billion in payments to the federal government for its illegal marketing of various drugs, including Zofran specifically.”
While GSK maintains that it never marketed Zofran as safe to treat morning sickness, Flynn claims the company did, conduct she refers to as “tantamount to using expectant mothers and their unborn children as human guinea pigs.”
According to the lawsuit, GSK allegedly:
- Failed to perform adequate testing on Zofran before promoting it “off-label” for morning sickness.
- Failed to warn the public and medical communities about the potential risks Zofran poses to fetuses when taken by pregnant women.
- Aggressively marketed Zofran without adequate knowledge of the drug’s potential to cause birth defects.
- Maintained that Zofran was safe for the treatment of morning sickness and hyperemesis gravidarum, though it was aware that neither the safety nor efficacy for this use had been established.
- Failed to include a black box warning regarding possible birth defects associated with Zofran use in pregnancy.
Zofran Cleft Lip Lawsuit Filed in Pennsylvania
August 27, 2015 – A Missouri couple filed a lawsuit against GSK today alleging that Zofran caused their son to be born with a cleft lip. As a result of the defect, the boy has been forced to undergo numerous surgeries, but significant visible scarring remains. Click here to learn more.
Do I Have a Zofran Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Zofran Lawsuits. We are handling individual litigation nationwide and currently accepting new birth defects cases in all 50 states.
Free Confidential Case Evaluation: Again, if your child or other loved one was born with a birth defect after the mother took Zofran in pregnancy, you should contact our law firm immediately. You may be entitled to compensation by filing a Zofran Suit and our lawyers can help.