The Legal Examiner Affiliate Network The Legal Examiner The Legal Examiner The Legal Examiner search instagram avvo phone envelope checkmark mail-reply spinner error close The Legal Examiner The Legal Examiner The Legal Examiner
Skip to main content

Two more Zofran lawsuits have been transferred to the US District Court of Massachusetts. In their complaints, women from Mississippi and Texas claim the potent anti-nausea drug holds the potential to cause major birth defects. With these most recent filings, a total of 282 lawsuits against Zofran’s manufacturer, the multi-national healthcare giant GlaxoSmithKline, have been consolidated in the Boston federal court.

Why Are Parents Filing Zofran Lawsuits?

Zofran has become a common choice for obstetricians who hope to alleviate the symptoms of morning sickness. The drug is commonly prescribed during the first trimester, when pregnant women are most likely to experience nausea and vomiting. This is also the most crucial period of fetal development, when an unborn child’s organs and body tissues are just beginning to form.

Despite being America’s most popular prescription morning sickness treatment, the US Food & Drug Administration has never approved Zofran for use in pregnant women. In fact, until recently, there was absolutely no research evidence that the drug – approved to treat nausea and vomiting among cancer patients – was even safe for pregnant women to take.

New studies, however, suggest that Zofran is not only unsafe during pregnancy, but may actually cause major birth defects in infants. Researchers at Harvard University have linked the drug to an increased risk for cleft palate, while teams in Europe have found an association with congenital heart defects. According to parents, however, GlaxoSmithKline never publicized these study results. The company, families accuse, utterly failed to warn obstetricians and pregnant women of Zofran’s possible risks. But their allegations go even further.

Rather than curb the drug’s use during pregnancy, parents say that GlaxoSmithKline chose to market Zofran specifically as a morning sickness treatment. This damning allegation, echoed by more than 280 mothers and fathers from across the country, was first raised by the US Department of Justice. In a lawsuit over alleged healthcare fraud, the US Federal Government accused GlaxoSmithKline of marketing multiple drugs – including Zofran – for unapproved “off-label” purposes. Off-label drug promotion is strictly illegal in the United States. While GlaxoSmithKline has never admitted to the government’s allegations, the company ultimately settled the Justice Department’s lawsuit for $3 billion.

New Zofran Filings Over Heart & Other Birth Defects

On October 12, 2016, two recent Zofran lawsuits were transferred to the US District Court of Massachusetts, a federal court in Boston where the litigation has been consolidated for pre-trial proceedings.

In a case initially filed in the US District Court for the Southern District of Texas, a mother from Petal, Mississippi says that prenatal exposure to a generic version Zofran led to her child’s numerous congenital abnormalities. The mother lists no less than 13 severe symptoms and fetal birth defects, including skeletal muscle atrophy and cardiomegaly, an abnormally enlarged heart. Her child, named as K.W. in the complaint, is now three years old.

The second new lawsuit was also filed originally in Texas. In her own complaint, a mother from Katy, Texas claims that a generic form of Zofran’s active ingredient caused her unborn child to develop cardiac septal defects. The woman names two specific “hole in the heart” abnormalities, atrial septal defect and ventricular septal defect.

Multiple large studies from Europe have linked Zofran to an increased risk for these “hole in the heart” defects. In one paper, Danish researchers found that Zofran’s active ingredient – a chemical known as ondansetron – could boost the risk for cardiac septal defects by 200% to 400%.

Learn More About Filing A Zofran Lawsuit

Other parents may still be able to file Zofran lawsuits. If your child developed major birth defects after being exposed to Zofran in utero, the experienced attorneys at Monheit Law can help. Contact us today to receive a free consultation. You can learn more about your rights and legal options at no charge and no obligation.


Comments for this article are closed.