In 1991, the Food and Drug Administration (FDA) supported the drug Zofran for use by cancer patients enduring chemotherapy and in need of nausea and vomiting relief.The drug was also eligible for use in post operative patients experiencing the same symptoms. However, it was later brought to the attention of the FDA that the manufacturers of Zofran, GlaxoSmithKline (GSK), were retailing the drug with the objective of it being used by pregnant women suffering from relentless nausea and vomiting. The FDA never backed Zofran as an anti-nausea medication during pregnancy and told GSK to have the drug come with a label warning of the risks that come with pregnant women taking Zofran. GSK never tested out the effects of Zofran on an unborn child, but they chose to market their drug as safe for pregnant women in need of relief from morning sickness.
In June 2015, an Ohio family filed a lawsuit against GSK citing that their drug Zofran, caused their daughter to be born with a congenital heart defect that resulted in her death just three days after being born. The complainant said she used Zofran during her pregnancy on the basis of the drug’s off-label marketing of Zofran being “a safe solution for pregnancy-related nausea.” Read more about the Ohio lawsuit here. Various epidemiological studies have proven that Zofran does indeed increase the chances of a baby being born with certain defects such as congenital heart defects and cleft palate.
Birth Defects Stats In Ohio
The Birth Defects Tracking in Ohio provides information about their program, The Ohio Connections for Children with Special Needs (OCCSN), which is important for understanding the impact of birth defects in the state.The census bureau’s Ohio population figure was 11,594,163 in 2014. The five most dominant cities based on numbers in the state were:
- Columbus- population 822,553
- Cleveland- population 390,113
- Cincinnati- population 297,517
- Toledo- population 282,313
- Akron- population 198,100
Considering Zofran was made accessible to the US market since 1991, it managed to secure 99% market share by 2005. This made Zofran one of the most prescribed drugs in America. Known data states a 1 in 33 chance of a baby being born with a birth irregularity. Applying this data our Zofran attorneys have processed feasible stats of births that were impacted by the presence of Zofran in the baby’s early developmental stages. Our attorneys did this by obtaining the numerical mean of danger ratios highlighted in the various studies undertaken. Our calculations reveal that nearly 6,500 infant births in Ohio were negatively impacted by Zofran consumption in the first 12 weeks of pregnancy which resulted in a birth irregularity.
Possible Cleft Palate And CHDs Cases In Ohio And Its Dominant Cities
Using the established Ohio population of 11,594,163, our estimations show that there were, 1,200 birth deformities that were a form of a cleft palate and 5,300 births with a congenital heart defect (CHD). For Ohio’s five dominant cities the established populations had the following cleft palate and CHDs:
Columbus- 435 child birth deformities with about 125 cleft palate, and 310 CHDs
Cleveland- 230 child birth deformities with about 90 cleft palate, and 140 CHDs
Cincinnati- 190 child birth deformities with about 78 cleft palate, and 112 CHDs
Toledo- 180 child birth deformities with about 76 cleft palate, 104 and CHDs
Akron- 140 child birth deformities with about 40 cleft palate, 100 and CHDs
What Are The Noted Adverse Effects Of Taking Zofran
Of the clinical studies that have been undertaken specific birth defects have been pinpointed, those being cleft palate and congenital heart defects, but these are not the only ones. A study performed by CDC and Sloan Epidemiology identified that expectant mothers who took Zofran in the first 12 weeks of pregnancy, exposed their unborn baby to a 2.37 chance of the infant being born with some type of irregularity. Read more about the study here.
Unfortunately, GSK has not acknowledged these facts about their drug causing birth defects, but this has not stopped lawsuits from being filed against the pharmaceutical company. Lawsuits that have been filed have seen litigants cite that Zofran caused the following abnormalities:
- Atroventricular Septal Defect
- Kidney Malformations
- Low set ears
- Bicuspid aortic stenosis
- Supraventricular tachycardia
- Facial Dysmorphia
- Cleft palate
Ohio Parents Using ZofranLegal.com To File Zofran Lawsuits
This website is purposed for use as a source of information about the Zofran litigation. ZofranLegal.com is backed by various law firms across the United States. However, our advocates are not certified to practice law in Ohio State, but we are certified to practice law in Delaware. We have offices in Delaware where we can file your case from, and Delaware is also an important state as that is where Zofran manufacturers GSK, have their headquarters. Should you wish to file your case in Delaware we can fully represent your case there.
There are several options available that will enable you to file your Zofran lawsuit. You can either bring your case to Delaware, as already mentioned above. In addition we may advise you to file your case at another apt venue or we may find it beneficial for you to file your case in Ohio with the aid of one of our network legal counsel. Please call us with any questions you may have and we will work with you to get your Zofran litigation started. For more information about our Zofran lawyers go here.