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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.
While this litigation is currently closed, learn more about a Zofran Drug Class Action from our team of attorneys.
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.
Plaintiffs have leveled a series of troubling accusations against GlaxoSmithKline:
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.
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.
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:
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.
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.
Continue Reading: Zofran Settlements: Have Any Lawsuits Ended Yet?