After a series of major epidemiological studies associated the anti-nausea drug Zofran to an increased risk for cleft palate and congenital heart defects, parents have begun to file lawsuits.
In at least 15 claims, families from across the nation allege that the common “off label” morning sickness treatment caused their children to be born with major birth defects.
With an estimated 1 million Zofran prescriptions written to pregnant women every year, many other families may be eligible to file lawsuits of their own.
Zofran Birth Defect Lawsuits: Families May Be Entitled To Compensation
Banville Law has joined forces with an alliance of distinguished plaintiffs’ attorneys to investigate potential Zofran birth defect lawsuits.
Led by Michael Monheit, Esq., our alliance includes a number of experienced personal injury attorneys, many of whom have devoted the majority of their practices to cases involving dangerous pharmaceutical products and large corporate Defendants.
Joining Banville Law are attorneys with decades of trial experience, legal professionals who have successfully taken on drug companies like Merck, and major industry players including Honda. Now, our attorneys have dedicated themselves to protecting the rights of parents and birth defect survivors nationwide.
If you were prescribed Zofran to alleviate the symptoms of morning sickness, and then gave birth to a child with birth defects, contact our attorneys today for a free consultation. You can learn more about your legal options and case eligibility, all at no cost and no obligation.
At Banville Law, we always provide legal counsel on a contingency-fee basis, so you owe us nothing until we secure a court award or settlement in your favor.
Why Are Families Filing Complaints?
Plaintiffs have leveled a series of troubling accusations against GlaxoSmithKline:
- They claim that the company promoted Zofran, a drug whose effects in pregnancy were never studied in clinical trials, as a “safe and effective” morning sickness treatment.
- Large-scale epidemiological studies have now identified an association between Zofran and an increased risk of major birth defects.
- Plaintiffs say that GlaxoSmithKline has failed to warn the public of mounting evidence that links Zofran to birth defect risks.
- They claim the company has received more than 200 reports of birth defects with Zofran as a suspected cause since 1992.
- Parents allege that GSK hid the results of early animal studies from the FDA. They say these studies revealed evidence of Zofran’s teratogenicity, it’s potential to alter fetal development.
- Families claim GlaxoSmithKline had both the ability and obligation to revise Zofran’s warning label with information on the drug’s association to birth defects. They say the company has failed in this duty.
According to Plaintiffs, their children were born with congenital abnormalities, their families incurred undue expenses and endured substantial hardship, as a result of GlaxoSmithKline’s alleged misrepresentations.
Below, you’ll find a detailed look at the allegations made in Zofran birth defect lawsuits.
Zofran is not FDA-approved for use during pregnancy. It’s not an approved morning sickness drug. But according to the US Federal Government, GlaxoSmithKline has been promoting it for that purpose, in violation of federal law.
In 2012, the US Department of Justice (DOJ) filed a number of charges against GlaxoSmithKline, international pharmaceutical conglomerate, and the world’s 7th largest drug company. While the government’s allegations pertained to several best-selling drugs, perhaps the most troubling among them involved Zofran. In its case, the Federal Government claimed GlaxoSmithKline had been promoting Zofran directly to obstetricians and gynecologists as a morning sickness treatment.
GlaxoSmithKline continues to deny this allegation but ultimately consented to a $3 billion settlement agreement.
Plaintiffs in Zofran birth defect lawsuits give new voice to this allegation, claiming the company’s alleged “off label” Zofran promotion placed a drug with unknown effects on fetal development into the hands, and bodies, of unknowing pregnant women around the world.
Birth Defects Associated With Drug In Multiple Studies
Not only is Zofran not approved for use during pregnancy, GlaxoSmithKline has never even studied its effects in pregnant women. But after news of the drug’s widespread “off label” use became public, an international group of medical researchers began to investigate Zofran’s potential risks for fetal development.
First to publish results was a team of public health researchers from Harvard University and Boston University’s Slone Epidemiology Center. Analyzing more than 10,000 birth and prescription records, they concluded that babies exposed to Zofran in utero were more than 2.37 times more likely be born with a cleft palate.
To learn more about the association between Zofran and cleft palate, click here.
Congenital Heart Defects
Next came a Danish team, who reviewed every birth record filed in Denmark between 1997 and 2010. Eventually, their 2013 study would include over 900,000 pregnancies. Cross-referencing these birth records with a database of prescription logs, the researchers identified every woman who had been prescribed Zofran’s active ingredient during the first trimester. These women were found to be anywhere from two to four times more likely to deliver children with congenital heart defects, including cardiac septal defects:
- atrial septal defect (2.1 times increased risk)
- ventricular septal defect (2.3 times increased risk)
- atrioventricular septal defect (4.8 times increased risk)
Repeating the study in 2014, Swedish researchers would find a similar risk: babies exposed to Zofran prenatally were 62% more likely to be born with congenital heart defects and more than twice as likely to have cardiac septal defects.
Find more information on the link between prenatal exposure to Zofran and heart defects here.
Manufacturer Concealed Evidence Of Potential Birth Defect Risks, Plaintiffs Claim
In their lawsuits, parents allege that GlaxoSmithKline has failed to notify patients and the health community of mounting evidence that Zofran is linked to increased birth defect risks.
They say that the company misrepresented the results of early animal studies, conducted prior to the drug’s approval, hiding evidence that Zofran caused fetal malformations in the offspring of rats and rabbits.
Plaintiffs say that GlaxoSmithKline began receiving reports of major birth defects with suspected ties to Zofran as early as 1992, only one year after the drug’s initial approval. Parents claim the company has received more than 200 such reports to date but has failed to report many to the FDA.
Along with the studies we mentioned above, parents consider these alleged warning signs sufficient evidence of Zofran’s risks, enough to have obligated the company to revise the drug’s prescribing information. But according to their complaints, GlaxoSmithKline has failed in its duty to warn pregnant women of Zofran’s association to major birth defects.
If these allegations are true, any woman who was prescribed Zofran as an “off label” morning sickness treatment and delivered a child with major birth defects may be eligible to file a lawsuit.