Multiple research studies have concluded that there is a possible link between the GlaxoSmithKline (GSK) manufactured drug, Zofran and birth defects. From 1991 Zofran was being frequently prescribed to pregnant women suffering from hyperemesis gravidarum (severe morning sickness). GSK has never carried out tests to establish the effects of Zofran has for morning sickness in pregnant women. The pharmaceutical giant has neither presented any evidence proving that the medication is safe for interaction with unborn babies.
What Was Zofran’s Intended Use?
When Zofran was released for public consumption, it was through the FDA’s approval of the drug for use in the treatment of intense nausea and vomiting generally experienced by people undergoing chemotherapy or postoperative nausea. The FDA never issued an approval of the drug to be used for any indication of hyperemesis gravidarum.
To make matters worse, GSK marketed Zofran as an answer for severe morning sickness. The company went as far as offering payment to health care professionals in order to entice them to publicize and write prescriptions for Zofran for morning sickness. In 2012 GSK denied claims from the Department of Justice that stated the drug Zofran was improperly marketed to OB/GYN’s. Although GlaxoSmithKline disputed these allegations, the company still settled the Department of Justice’s case for a sizable $3 billion.
North Carolina Birth Defect Stats
North Carolina’s population in 2014 was 9,943,964 as per the latest census data. Of that estimate, the most populous cities were:
- Charlotte- 792,862 population
- Raleigh- 431,746 population
- Greensboro- 279,639 population
- Durham- 245,475 population
- Winston-Salem- 236,441 population
The CDC projects a one in 33 chance of a baby being born with a birth defect in the United States. The North Carolina State Center for Health Statistics reports that 1 in 662 live births is a cleft lip and palate birth defect. Upon its 1991 FDA approval, Zofran became the go to drug for fighting against morning sickness in expectant mothers. By 2005 the drug had claimed almost 99% of the market share. Going by this knowledge as well as using the averages of risk estimates established in numerous researches, we have assessed that almost 5,700 births in North Carolina had birth abnormalities due to the presence of Zofran in the first twelve weeks of the pregnancy.
What Are The Predicted Figures Of Babies Born With Cleft Palate & CHD In North Carolina & Its Primary Cities?
Utilizing our figure of 5,700 possible birth deformities in North Carolina, we determined that 1,030 of that figure are some form of cleft lip and cleft palate and 4,670 resulted in heart defects such as ASD, VSD or heart murmur.
Incorporating North Carolina’s primary cities’ populations, we estimate the following birth defect figures:
- Charlotte- 420 weighted sum of birth defects, with 120 cleft palate and 300 congenital heart defects
- Raleigh- 250 weighted sum of birth defects, with 90 cleft palate and 160 congenital heart defects
- Greensboro-180 weighted sum of birth defects, with 80 cleft palate and 100 congenital heart defects
- Durham- 175 weighted sum of birth defects, with 70 cleft palate and 105 congenital heart defects
- Winston-Salem- 160 weighted sum of birth defects, with 65 cleft palate and 95 congenital heart defects
Child Birth Defects Or Side Effects Affiliated With Zofran Consumption
As specified above, GSK has not admitted that Zofran is the cause of child birth defects when taken by expectant moms in the first twelve weeks of pregnancy. However, studies performed discredit GSK’s stance. Lawsuits that have been brought forward claim that Zofran some of the abnormalities below:
- Kidney defects
- Low set ears
- Cardiac septum defects
- Facial dysmorphia
- Cleft Palate and cleft lip
Visit our info graphic to see the increased likelihood of certain birth defects to occur due to Zofran.
I Think I Might Have A Zofran Case
Upon reading the information provided above and a lot of it sounds very similar to what you or your loved one has gone through, you may have a Zofran lawsuit. Our advocates are gathering information about numerous birth abnormalities related to Zofran. Contact us and we can give you important news related to Zofran. If you definitely took Zofran in the first few months of pregnancy and gave birth with any of the abnormalities we mentioned- you may be entitled to compensation.
Who Are The North Carolina Zofran Lawyers?
The law offices of Janet, Jenner & Suggs, LLC houses licensed attorneys to practice law in North Carolina. Our North Carolina attorneys are well adept and come with great experience in dealing with these types of lawsuits.
Please contact us here, to speak to our North Carolina attorneys.