Monheit Law Reports: Plaintiffs Say GlaxoSmithKline Hid Evidence Of Zofran’s Potential To Harm Unborn Children

Attorneys at Monheit Law report that at least ten families have now brought legal claims against pharmaceutical giant GlaxoSmithKline, in an ongoing litigation surrounding the anti-nausea drug Zofran. A series of major epidemiological studies has linked Zofran to increased risks of birth defects and, in recent lawsuits, plaintiffs say that GlaxoSmithKline has been aware of Zofran’s potential to cause fetal harm for over two decades. Rather than warn the public, parents allege that GlaxoSmithKline concealed safety information from the FDA and medical community. In fact, they say that GlaxoSmithKline has violated federal law, claiming that the company has been promoting Zofran as an “off label” morning sickness treatment.

GlaxoSmithKline has manufactured the drug ondansetron since the early 1990s. Promoted under the brand name Zofran, ondansetron is approved by the US Food & Drug Administration to treat severe nausea and vomiting in patients receiving cancer therapies and surgical anesthesia. Zofran has not been approved for use during pregnancy. Nor has GlaxoSmithKline ever studied its effects on pregnant women or their unborn children. Despite these facts, medical experts have observed a sharp rise in Zofran’s “off label” prescription for morning sickness.

Under federal law, pharmaceutical manufacturers are not permitted to promote their products for unapproved uses. But according to allegations leveled in recent lawsuits, GlaxoSmithKline began marketing Zofran to doctors as a safe and effective morning sickness treatment immediately after the drug's approval in 1991. From 1983 to 2013, there was no FDA-approved treatment for morning sickness in the US. Plaintiffs say that with “an estimated 70-85% of [all pregnant women experiencing morning sickness], the absence of a prescription medication that was approved by the FDA for pregnancy-related nausea presented an extremely lucrative business opportunity.”

Indeed, the US government charged GlaxoSmithKline for unlawfully promoting Zofran as a “safe and effective” drug during pregnancy in 2012. In a landmark case, the US Department of Justice claimed that the company had even “paid illegal remuneration to health care professionals to induce them to promote and prescribe Zofran.” Although the company ultimately settled the federal government’s charges for a record-setting $3 billion, GlaxoSmithKline continues to deny all allegations that it promoted Zofran for “off label” use.

Multiple epidemiological studies have now found an association between prenatal exposure to Zofran and increased risks of birth defects. Reviewing hundreds of thousands of birth records, teams in Europe found significant increases in the rate of congenital heart defects among babies exposed to Zofran before birth. In the US, researchers at Harvard and Boston University found that women prescribed Zofran’s active ingredient were more than twice as likely to deliver babies with cleft palate.

As a result, parents have begun to come forward. To date, at least ten families have filed lawsuits against GlaxoSmithKline. These parents say that they were prescribed Zofran as a morning sickness treatment, and that the drug caused their children to be born with birth defects.

In line with recent scientific findings, seven of these Zofran birth defect lawsuits involve congenital heart defects (CHD). In one complaint, case number 1:15-cv-10429, a mother from Boston claims that Zofran caused her daughter’s three CHDs: aortic arch hypoplasia, right ventricular hypertension and atrial septal defect. Notably, three of the studies that have found an association between Zofran and birth defects observed an increased risk of “cardiac septal defects,” a category that includes atrial septal defect. In case 2:15-cv-00709PD, a mother says that exposure to Zofran caused CHDs during two separate pregnancies. Both of her daughters were born with what court documents refer to as “hole in the heart” defects, a phrase commonly used to describe cardiac septal defects. A family from Texas, in case number 5:15-34, alleges that their son was diagnosed with a heart murmur, a common symptom of cardiac septal defects, after being exposed to Zofran during the first trimester. Parents from San Francisco say that their son was born with bicuspid aortic stenosis as a result of Zofran, in case CGC-15-544524. And in complaint R615761042, a mother from Oakland, California claims Zofran caused her son to be born with supraventricular tachycardia, a defect that inhibits the heart’s electrical system.   

Thus far, two lawsuits involve orofacial clefts like cleft palate. In case number 1:15-cv-00026-SPW-CSO, filed in Montana, parents claim that exposure to Zofran resulted in their daughter being born with both a cleft palate and lip. Court documents report that she “has been forced to undergo ten surgeries” to repair her congenital defects.  

Families interested in learning more about these lawsuits can find detailed summaries at ZofranLegal.com, a resource developed by Monheit Law. Dedicated to protecting the rights of families, Monheit Law has assembled a multi-state coalition of attorneys to investigate Zofran-related claims. Their attorneys currently offer free consultations to any parent who believes that exposure to Zofran may have caused their child to develop birth defects. Birth defect survivors and families can call 1-877-620-8411 for more information.