Clinical research studies have correlated Zofran with a heightened chance of a baby being born with birth abnormalities in the form of cleft palate, congenital heart defects, but not limited to these types only. Zofran also referred to as Ondansetron, was endorsed to be used by cancer patients and those who have gone through a medical procedure suffering from nausea, by the Food and Drug Administration (FDA) in 1991. Unfortunately, Zofran began being wrongfully prescribed by doctors, with the encouragement of GlaxoSmithKline (GSK), as an off-label drug for alleviating intense morning sickness in expectant moms. The FDA did not ever give the go ahead for Zofran to be used by expectant mothers, nor were there any well documented research studies from GSK that could allow them to market this drug as anit-nausea medication for pregnant women.
Moreover, since studies show that Zofran increases the chances of an unborn baby being born with a birth deformity, lawsuits have since been filed attesting to this truth and reality. These lawsuits assert that the makers of Zofran were aware of the dangers Zofran posed to pregnant women and fetal development, but did not do anything to warn the public as well as doctors who prescribed this drug. To add insult to injury GSK, resolved a litigation with the DOJ (Department of Justice) where the company was being accused of wrongfully advertising drugs, including Zofran and went as far as bribing doctors to write scripts for their drugs. However, GSK denies that their drug Zofran causes birth abnormalities.
Birth Abnormality Figures In Rhode Island
Of the 10,500 babies born in Rhode Island each year, about 500 babies (1 in 21) are born with a birth defect. Across America, statistics are recorded as 1 in 33 babies born with a birth abnormality. Rhode Island’s population as per the most recent census data was 1,055,173. Of that number the five most densely inhabited cities are:
- Providence- population 179,154
- Warwick- population 81,963
- Cranston- population 81,037
- Pawtucket- population 71,499
- East Providence- population 47,331
Considering Zofran was introduced to the United States market in 1991, it instantaneously became the drug with the most written scripts in the United States. It is understood that Zofran gained 99% market share by 2005. Using this knowledge our Zofran attorneys have processed probabilities of the number of births that were affected by the presence of Zofran in utero, while also incorporating the average risk ratios established in the clinical studies undertaken. We evaluated that almost 595 births in Rhode Island were affected by the presence of Zofran in utero.
Cleft Palate and Congenital Heart Defects Evaluations In Rhode Island & Immediate Major Cities
Of the figure above of 595 likely birth abnormalities, we have evaluated how many of those were cleft palate and congenital heart defects (CHDs). The figures were 149 that were cleft palate and 446 that were CHDs. We further broke down these numbers for Rhode Island’s five major cities recorded above.Our evaluations of these cities were:
- Providence- 134 possible total birth abnormalities:17 evaluated as cleft palate: 117 evaluated as CHDs
- Warwick- 88 possible total birth abnormalities:7 evaluated as cleft palate: 81 evaluated as CHDs
- Cranston- 88 possible total birth abnormalities:8 evaluated as cleft palate: 80 evaluated as CHDs
- Pawtucket- 84 possible total birth abnormalities:7 evaluated as cleft palate: 77 evaluated as CHDs
- East Providence- 72 possible total birth abnormalities:4 evaluated as cleft palate: 68 evaluated as CHDs
Unfavorable Effects Of Taking Zofran On An Unborn Baby
Numerous lawsuits that have been brought to court have seen litigants say they were given Zofran in the early weeks of pregnancy, but were not given heed of the dangers associated with taking this drug. The litigants subsequently gave birth to babies with serious birth abnormalities. Some of the reported Zofran related unfavorable effects or birth defects that have been:
- bicuspid aortic stenosis
- supraventricular tachycardia
- hole in the heart
- facial dysmorphia
- webbed toes
- low set ears
- renal deformations
- cleft palate
- congenital talipes equinovarus
Rhode Island Parents Searching For Zofran Related Answers
This website is subsidized by several law firms in various geographical locations, for the sole reason of contributing information about the Zofran litigation. Although our Zofran advocates are in various locations, they are not licensed to practice law in Rhode Island state. However, we are authorized to practice law and currently hold offices in Delaware State. Delaware is an important state as that is where GlaxoSmithKline has its headquarters. This means we can stand for your family’s legal rights if a case is filed in Delaware.
There are several ways we propose you file your lawsuit. We can propose you file in Delaware or another convenient location, or it may be appropriate for you to file in Rhode Island using one of our trusted network attorneys. Please call us if you need more information. Our Zofran lawyers are ready to speak to you at any time. Click here to know more about the Zofran advocate team.