A number of law firms have produced television commercials about an ongoing litigation surrounding the anti-nausea drug Zofran. The commercials mention serious allegations that Zofran, a common treatment for morning sickness, has the potential to cause major birth defects. Ads might mention specific congenital abnormalities like cleft palate or congenital heart defects. They conclude by urging women who were prescribed Zofran during pregnancy, and then delivered children with birth defects, to seek legal counsel immediately.
Banville Law does not produce TV commercials, about the Zofran litigation or any type of lawsuit. But our experienced attorneys have joined an alliance of distinguished plaintiffs’ lawyers to pursue potential Zofran claims.
While this litigation is currently closed, learn more about cases from our Zofran attorneys.
Something we’ve noticed about these commercials is that they don’t actually say much about Zofran, its possible link to birth defects, or the many lawsuits that are being filed right now against GlaxoSmithKline, the drug’s manufacturer.
We want to fix that. Below, you’ll find the 4 facts every parent should know about Zofran.
At least that’s what the US Department of Justice (DOJ) claimed in a 2012 lawsuit, one that would eventually become the largest settlement for alleged healthcare fraud in US history.
In its landmark case, the Federal Government charged GlaxoSmithKline for promoting a number of drugs to healthcare professionals for “off label,” or unapproved, uses, which is illegal under US law. One of the drugs named in the Government’s complaint was Zofran. The DOJ claimed that the company had promoted its anti-nausea drug as a “safe and effective” treatment for morning sickness directly to obstetricians and gynecologists.
But Zofran has never been approved for use during pregnancy. In fact, GlaxoSmithKline has never even studied the drug’s effects in pregnant women, or those it may have on their unborn babies.
While the company continues to deny any wrongdoing in relation to Zofran, the Government maintains that its allegations were “well-founded.” A number of families have brought these claims back into the spotlight, by filing Zofran birth defect lawsuits. Parents say that GlaxoSmithKline’s alleged “off label” promotion placed a drug with unknown effects on fetal development into the hands of pregnant women around the world.
Now that millions of women have been exposed to Zofran’s active ingredient (ondansetron) during pregnancy, medical researchers have been able to investigate its potential effects on their unborn children.
In 2012, a team of public health researchers at Harvard and Boston Universities reviewed more than 10,000 birth records, and found that women prescribed Zofran during the first trimester were 2.37 times more likely to deliver children with a cleft palate.
The following year, Danish researchers analyzed every birth record filed in Denmark between 1997 and 2010. Ultimately, the study included almost 900,000 pregnancies. Babies exposed to ondansetron in utero were 60% more likely to be born with congenital heart defects, and between 2 and 4 times more likely to be born with “cardiac septal defects” like atrial and ventricular septal defect. A study conducted by Swedish researchers in 2014 would only support that association, finding that among more an 1.5 million pregnancies, women prescribed Zofran were more than twice as likely to deliver children with cardiac septal defects.
Based on these scientific findings, most of the currently-filed Zofran birth defect lawsuits involve children born with congenital heart defects, although at least two have been brought on behalf of babies born with orofacial clefts like cleft palate.
In their lawsuits, more than a dozen families claim that GlaxoSmithKline began receiving reports of birth defects with suspected ties to Zofran almost immediately after the drug was approved in 1991. Parents say the company has received more than 200 of these reports to date, but has failed to properly submit them to the FDA.
Plaintiffs also cite a series of early animal studies conducted by GlaxoSmithKline prior to Zofran’s initial approval. The company allegedly characterized these tests, which involved pregnant rats and rabbits, as showing no evidence of fetal harm in approval application documents. But according to Plaintiffs, the studies actually revealed evidence of Zofran’s teratogenicity, its ability to alter fetal development in harmful ways. They say many of the animal offspring presented signs of incomplete bone growth, while others died in utero or were born prematurely.
In light of the studies linking Zofran to major birth defects, these families accuse GlaxoSmithKline of failing to warn the public, patients and health community of the drug’s potential risks.
If those allegations are true, any woman who delivered a child with major birth defects after being prescribed Zofran as an “off label” treatment for morning sickness may be eligible to file a claim against GlaxoSmithKline.
The attorneys at Banville Law are currently offering free case eligibility evaluations free of charge. In a consultation with one of our experienced lawyers, you can learn more about your legal options and the ongoing Zofran litigation.
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