A heightened chance of a baby being born with deformities like, but not limited to, cleft palate and congenital heart defects have been linked to Zofran in various clinical research studies conducted all over the world. Zofran is the brand name for the drug of Ondansetron, which is given to individuals experiencing nausea and vomiting (NVM). The drug was specifically created to be used by people experiencing this type of affliction due to chemo therapy and radiation therapy or for people who’ve had post operative procedures. The Food and Drug Administration in 1991 authorized Zofran to be used for these exact purposes. However, Zofran started being marketed by its makers, GlaxoSmithKline (GSK), as an off-label drug, for use in pregnant women who were suffering from hyperemesis gravidarum which is extreme nausea and vomiting suffered by some pregnant women. Zofran was never approved by the FDA for such uses and lawsuits are being filed for birth deformities that have happened due to this misrepresentation of the drug.
In July, 2015, a family residing in Bismarck, North Dakota, was one of the family’s filing a lawsuit against GSK for the birth defect their child suffered. The mother of the baby was prescribed Zofran in the first three months of pregnancy to combat her morning sickness. However, the mother carried on taking the drug throughout her pregnancy and subsequently gave birth to her son who was diagnosed with crippling kidney defects. For more information about this lawsuit, click here.
North Dakota: Birth Irregularities Information
According to North Dakota.gov every four and one-half minutes a baby is born in the United States with a birth defect. Birth defects cause one in every five infant deaths and lead to $2.6 billion per year in hospital costs alone in the United States. In North Dakota, birth defects account for about twelve infant deaths every year.
Furthermore, national estimations show that for every 33 infants one is born with a birth irregularity. Considering Zofran came on the American market following its 1991 FDA approval, it quickly became the number one drug chosen for fighting morning sickness in expectant moms. By 2005 it had a near 99% market share. North Dakota’s population figure in 2014 is estimated to be 739,482.
North Dakota’s five most densely inhabited cities had the following figures:
- Fargo- 105,549 population
- Bismarck- 61,272 population
- Grand Forks- 52,838 population
- Minot- 40,888 population
- West Fargo- 25,830 population
Employing our knowledge of Zofran’s market share, our attorneys have worked out the credible number of infant births that were affected by Zofran while also using the averaged risk ratios cited in different clinical studies conducted. We evaluated a total of 397 births in North Dakota that were negatively affected by consuming Zofran in the first three months of a baby’s development.
North Dakota Figures Of Cleft Deformities And CHDs Associated With Zofran
Zofran was known to have three patents when it was introduced onto the market. These patents helped Zofran to have market control all the way to 2006. Furthermore, generic versions also became accessible. If the ratios and contingencies recorded in epidemiological studies are correct, then we evaluate that close to 397 infant birth deformities in North Dakota were brought on by Zofran usage in the first three months of pregnancy. From that number we have evaluated that 70 birth deformities were a form of cleft palate and 327 births resulted in congenital heart defects (CHDs). For the five biggest cities in North Dakota we calculated the following figures:
- Fargo- calculated total birth deformities: 99 | were likely cleft palate: 9 | were likely CHDs: 90
- Bismarck- calculated total birth deformities: 79 | were likely cleft palate: 6 | were likely CHDs: 73
- Grand Forks- calculated total birth deformities: 75 | were likely cleft palate: 5 | were likely CHDs: 70
- Minot- calculated total birth deformities: 69 | were likely cleft palate: 4 | were likely CHDs: 65
- West Fargo- calculated total birth deformities: 62 | were likely cleft palate: 2 | estimated CHDs: 60
Zofran Related Adverse Deformities
As already specified in this article, various clinical studies undertaken by different medical communities have correlated Zofran with a heightened prospect of a baby being born with deformities like congenital heart defects and cleft palate. Despite the fact that GSK neglects to accept the fact that their drug causes birth deformities, there have been filed lawsuits that have seen litigants state the contrary about the adverse effects suffered from using Zofran. These are some of the Zofran related adverse deformities:
- Hole in the heart defects
- Kidney Malformations
- Webbed Toes
- Low set ears
- Facial Dysmorphia
- Cleft Palate
We have prepared an infographic with information about a study that was conducted in the US in 2012, revealing a 2.37 times increased risk of an infant being born with a cleft palate in situations where the mom was administered Zofran for morning sickness in her first three months of pregnancy. Pregnant moms who did not take this drug for morning sickness did suffer the same fate.
Parents From North Dakota Connecting Via ZofranLegal.com For Lawsuit Info
The website you visited is subsidized by various law firms located in many areas in the United States. The reason this website exists is for the objective of supplying relevant news about the Zofran litigation. Although our legal advocates are not authorized to practice law in North Dakota, we are authorized to practice law in Delaware. We also have offices in Delaware that make it easier for us to file your case in this state, which is also the state where Zofran manufacturers have their main offices.
In order to file your litigation, we offer several suggestions for you to successfully file your case. As already mentioned, we have offices and are authorized to practice law in Delaware, therefore we can file your case in that state, or at another convenient location. Alternatively, dependent upon your situation we may suggest your case be handled by local North Dakota counsel. We have an extensive network that we can call upon to represent you in North Dakota. For more information about our Zofran attorneys click here.