Several law firms have produced television commercials that inform parents of an ongoing litigation surrounding the anti-nausea drug Zofran. These commercials focus on allegations that Zofran, a drug commonly prescribed to pregnant women during the first trimester, may cause congenital birth defects. Ads might mention specific abnormalities, particularly congenital heart defects and cleft palate. They end by urging mothers who took Zofran as a morning sickness treatment, and then gave birth to children with birth defects, to seek legal counsel immediately.
ZofranLegal.com is sponsored by a national alliance of plaintiffs’ attorneys dedicated to the rights of parents and birth defect survivors. While our lawyers do not produce commercials, we are providing consultations at no charge to any family interested in finding more information on Zofran, its association to major birth defects and their own case eligibility.
If the TV commercial you watched seemed to describe your family’s situation, the lawyers of ZofranLegal.com are prepared to answer your questions. Call 1-877-500-9202 or complete our online contact form to discuss your circumstances with an experienced attorney now.
What Zofran TV Commercials Haven’t Told You About Birth Defect Lawsuits
One thing we’ve noticed is that these commercials aren’t very informative. We want to fix that. In this article, we’ll present the 5 facts every family should know about the Zofran litigation.
1. Zofran Has Never Been Approved For Use During Pregnancy
Zofran is not an FDA-approved morning sickness treatment. It is not approved for any use during pregnancy. In fact, GlaxoSmithKline, the drug’s manufacturer, has never studied Zofran’s effects during pregnancy, or the possible risks it might present to an unborn baby.
In the early 1990s, Zofran was approved by the US Food & Drug Administration to treat three particular forms of nausea and vomiting:
- nausea and vomiting in cancer patients receiving chemotherapy
- nausea and vomiting in cancer patients receiving radiotherapy
- nausea and vomiting in patients receiving surgical anesthesia
But public health experts have reported that many physicians also prescribe Zofran to treat the morning sickness that most women experience at some point during pregnancy. More often than not, morning sickness begins early in the first trimester, when the risk of a growing baby developing birth defects is at its highest.
Doctors are allowed to prescribe drugs for unapproved uses; it’s called “off label” prescription and is surprisingly common. Some studies have found that more than one out of every five prescriptions is written for an unapproved use. Off label prescription isn’t regulated by the FDA in any way.
2. The Federal Government Charged GlaxoSmithKline For Promoting Zofran As A “Safe & Effective” Morning Sickness Treatment
But under federal law, pharmaceutical manufacturers are prohibited from marketing their drugs for off label uses. According to allegations made by the US Department of Justice, that’s exactly what GlaxoSmithKline (GSK) did with Zofran.
In 2012, the federal government filed a lawsuit against GSK. In its complaint, the government claimed that the company had promoted a number of drugs directly to doctors for uses that had never been approved by the FDA. In fact, some of those uses had been reviewed, and explicitly rejected, by federal scientists.
One of the drugs named in the Department of Justice’s case was Zofran. The government charged GlaxoSmithKline for promoting Zofran to obstetricians and gynecologists as a “safe and effective” medication for pregnant women to take. As we’ve already mentioned, the company had never studied Zofran’s effects during pregnancy, and therefore had no valid way of knowing whether or not it was safe for pregnant women or their unborn babies.
GSK ultimately pled guilty to several of the government’s charges, and entered a settlement agreement for $3 billion. But the company maintains that it never marketed Zofran to doctors as a morning sickness treatment.
3. Researchers Have Linked Zofran To Increased Birth Defect Risks
Whether or not GSK unlawfully marketed Zofran for use during pregnancy, the drug has now been taken by hundreds of thousands of women during the first trimester. And researchers, concerned by the fact that so many unborn babies are being exposed to the drug, have started investigating its effects on fetal development. Preliminary studies have been troubling.
In 2012, researchers at Harvard University found that women who were prescribed Zofran during early pregnancy were 2.37 times more likely to deliver babies with a cleft palate.
In 2013 and 2014, three independent teams in Denmark and Sweden reviewed hundreds of thousands of birth records to find out what effects Zofran may have on unborn babies. All three found significantly increased rates of congenital heart defects. Specifically, the researchers found that women who took Zofran were far more likely to deliver babies with cardiac septal defects, like atrioventricular septal defect, atrial septal defect and ventricular septal defect.
4. Women & Parents Have Begun To File Zofran Birth Defect Lawsuits
At least seven families have now filed lawsuits against GlaxoSmithKline: mothers and fathers from across the nation who say that prenatal exposure to Zofran caused their children to be born with birth defects.
Like the federal government, plaintiffs insist that GSK promoted Zofran to doctors as a morning sickness treatment, without any evidence that the drug was safe for pregnant women or their unborn children. In fact, they claim that GSK had significant knowledge to the contrary.
These families say that GSK has been aware of Zofran’s potential risks for more than two decades. If their allegations are true, the company has been receiving reports of birth defects associated with Zofran exposure since as early as 1992. They claim that GSK has received more than 200 of these reports to date. Parents allege that federal law obligated GlaxoSmithKline to include information on these reports, as well as the studies covered above, on Zofran’s warning label. But as plaintiffs note, Zofran’s labeling information hasn’t carried any new pregnancy information since 1993.
As a result, these families say that GlaxoSmithKline has failed to warn the public and medical community of Zofran’s potential risks during pregnancy. In fact, they maintain that GSK promoted its drug for use during pregnancy, even in the face of mounting evidence that Zofran may actually increase the risk for major birth defects.
5. Other Families May Be Eligible To File Their Own Claims
If the allegations made in these Zofran birth defect lawsuits are true, then any mother who was prescribed Zofran during the first trimester, and then delivered a child with major birth defects, may be eligible to bring a claim for compensation against GlaxoSmithKline.
Our attorneys are here to help. ZofranLegal.com was established by a coalition of dedicated lawyers, professionals with decades of experience representing Americans who have been harmed by dangerous pharmaceutical products. We encourage you to look around our site and learn more.
If you’re ready to speak with an attorney about your own case eligibility, feel free to call 1-877-620-8411 or fill out our contact form. Your consultation is free, and comes at no obligation.