cleft palate zofran lawsuit

New Cleft Palate Zofran Lawsuit Puts Attention Back On 2012 Risk Study

On July 17, 2015, the growing Zofran litigation saw a flurry of activity, as two families became Plaintiffs, filing lawsuits in Massachusetts and Mississippi.

In the Massachusetts claim, parents say the popular anti-nausea drug caused their son’s heart condition, a ventricular septal defect (VSD).

Heart defects have featured in the majority of Zofran lawsuits, since two major studies in 2013 and 2014 found an association between the drug and more than doubled risks for cardiac septal defects, a category of heart abnormalities that includes VSD, atrial septal defect and atrioventricular septal defects.

Mississippi Zofran Lawsuit Draws On Harvard Cleft Palate Study Results

But the lawsuit filed in Mississippi brought the legal community’s attention back to a previous research initiative, one that linked Zofran to cleft palate. Far fewer claims have been filed in relation to such “orofacial clefts,” despite the 2012 Harvard-led study having linked prenatal exposure to Zofran and a more than two-fold increase in clefts.

The family’s complaint was filed in the US District Court for the Southern District of Mississippi, Western Division, and believed to be the first claim filed in that state. Registered under the case number 5:15-cv-00070-DCB-MTP, a copy of the court documents can be downloaded as a .PDF below:

View Complaint: 5:15-cv-00070-DCB-MTP

Was Boy’s Soft Cleft Palate Caused By Zofran?

In the complaint, a mother writes that she was prescribed Zofran for morning sickness “beginning early in her first trimester” in 2014.

cleft palate zofran lawsuit

Cleft palate following repair.

When women began taking Zofran has become an important factor of these lawsuits, because fetal organs are almost completely developed by the end of the first trimester. Morning sickness’ onset, usually early in the first trimester, has meant that most women taking the drug will expose their unborn babies during the most crucial periods of organ development.

C.P.T., the family’s son, was born in January 2015, and diagnosed with a soft cleft palate, a split or opening in the roof of his mouth, his parents claim.

While the parents have provided no further details on C.P.T.’s condition or treatment, we can infer that the child’s cleft, or split, affects primarily his soft palate, the flexible membrane extending back towards the throat.

Learn more about cleft palate here.

Three Years Earlier, Researchers Find Cleft Palate Link

In 2012, a team at Harvard and Boston University, funded by a grant from the US Centers for Disease Control & Prevention, set out to investigate the effects of common “off label” morning sickness treatments on fetal development.

Using data compiled by Boston University’s Slone Epidemiology Center, the researchers identified 22,381 women who had reported taking at least one medication for pregnancy-related nausea. More than 70 different pharmaceuticals were identified as potential morning sickness treatments, among them Zofran’s active ingredient ondansetron.

Then they identified which women had given birth to children with congenital abnormalities, leaving aside babies born with heart defects.

Two large categories of drugs, steroids and proton pump inhibitors, were associated with an increased risk for hypospadias, a defect in which the urethra opens on the underside of a male newborn’s penis.

Zofran was the only other drug for which an increased risk was identified. Women prescribed the drug were 2.37 times more likely to deliver children with a cleft palate.

Diclegis: Studies Say New Morning Sickness Drug Is Safe

Plaintiffs point out that a new drug, specifically approved for the treatment of morning sickness, was recently released on the US market. With a wealth of clinical study data supporting its safety and efficacy, Diclegis is the first drug to be approved for pregnancy-related nausea in 30 years.

While other parents have noted Diclegis’ approval in their own lawsuits, the drug is particularly salient in the case of the present Plaintiff. Becoming pregnant in 2014, she could very well have opted to take Diclegis instead of Zofran, if she’d only been aware of the latter drug’s link to birth defect risks.

The mother says she had no reason to fear Zofran’s potential effects on C.P.T., and blames GlaxoSmithKline’s allegedly fraudulent marketing scheme for her ignorance. She claims she did not become aware of Zofran’s alleged “dangerousness” until April of 2015.

Zofran Lawsuits Rise Over 40

Monheit Law has just obtained court documents relating to 7 new lawsuits filed in the first half of September, bringing the total number of Zofran lawsuits as of September 17, 2015 to at least 41.

We’ll be making those complaints public over the coming weeks.