In the early 1980s drug company GlaxoSmithKline (GSK), carried out tests on animals like rabbits to determine the adverse effects their drug, Zofran has on humans. For them, the tests did not show any risks of the drug causing harm to humans. In 1991, the drug Zofran, was accepted for use by the Food and Drug Administration (FDA). The FDA allowed the drug to be used specifically as an anti-nausea medication for cancer and post-operative patients suffering from nausea and vomiting due to their treatments. However, GSK went ahead and promoted Zofran for use in pregnant women experiencing nausea due to intense morning sickness.
Although, GSK did not adequately test whether or not Zofran was safe for use in pregnant women, they received information in 1991 of birth irregularities that involved the expectant moms using Zofran for nausea and vomiting in the early stages of pregnancy. GSK, did not use this information to further clarify if Zofran was the culprit behind these defects and possibly more. Instead, it has been cited that GSK went ahead to promote Zofran as a safe drug to use as an anti-nausea medication in pregnant women, even going as far as offering payoffs to medical professionals to write Zofran scripts. GSK was brought to court for this unlawful behavior and pleaded guilty to illegally promoting Zofran for preventing morning sickness (among various allegations) and paid a $3 billion fine.
Sufficient tests have been carried out by members of the medical community in order to determine the real effects Zofran has on an unborn child, and the results have come back stating that Zofran when used in the first 12 weeks of pregnancy, is likely to lead to a baby being born with a cleft lip or palate and congenital heart defects among other abnormalities. Read more about the studies here. Needless to say, many families from all over America have come forth and filed lawsuits against GSK because of Zofran usage that led to their children being born with birth defects.
Congenital Birth Defect Estimates In Hawaii
Hawaii’s population as recorded in the most recent census data is 1,419, 561. Of that figure, the most populous cities were:
- Honolulu- 371,657 population
- Pearl City- 47,698 population
- Hilo- 43,263 population
- Kailua- 38,635 population
- Waipahu- 38,216 population
The Hawaii Birth Defects Program (HBDP) provides population-based surveillance for birth defects in Hawaii, click here to visit the website. The Centers for Disease Control and Prevention (CDC) estimates that for every 33 newborns there is likely going to be one born with a birth deformity. From the time Zofran was made public for the American market, it speedily increased in popularity and was heavily prescribed to the point that it amassed 99 per cent of the market. Our Zofran attorneys used this information to forecast probable Zofran related cases in Hawaii by using the numerical means of risk ratios that were determined in the various medical studies completed. We forecast that there were almost 765 newborn births in Hawaii where Zofran ingestion in utero during the first 12 weeks of pregnancy resulted in a birth abnormality.
Potential Numbers Of Cleft Palate And CHDs In Hawaii And Its Main Cities
As stated above, Zofran became available in the US in 1991. It held three patents that helped Zofran claim market dominance right up to 2006 and after that generic versions were introduced. Our forecast reveals that of the above total birth defects of 765 there were,133 newborn deformities that were some kind of cleft palate, and 632 births with congenital heart defects (CHDs). For Hawaii’s main cities our birth abnormalities forecast is as follows:
- Honolulu- 224 newborn birth deformities (nearly: 34 cleft palate and 190 CHDs)
- Pearl City- 72 newborn birth deformities (nearly: 4 cleft palate and 68 CHDs)
- Hilo- 70 newborn birth deformities (nearly: 4 cleft palate and 66 CHDs)
- Kailua- 68 newborn birth deformities (nearly: 4 cleft palate and 64 CHDs)
- Waipahu- 68 newborn birth deformities (nearly: 6 cleft palate and 62 CHDs)
What Have Been The Stated Side Effects Connected With Zofran Usage?
Regardless of the many comparative medical studies undertaken to determine the effects Zofran has on an unborn child, GSK still does not take these into consideration and accept that their drug causes such harm. Nonetheless, the cases that have been brought to court have seen litigants state that Zofran led to a baby being born with some of the following abnormalities:
- Hole in the heart abnormalities
- Renal malformations
- Low set ears
- Facial dysmorphia
- Cleft palate
- Cleft lip
- Talipes equinovarus
There has also been a very specific study that strongly correlated Zofran to being an agent that doubles the risk of a baby being born with a cleft palate, if Zofran was in the baby’s system in the first 12 weeks of pregnancy. Read more about this study here.
Hawaii Parents Turning To ZofranLegal.com For Justice
A number of law firms are the benefactors of ZofranLegal.com, who created the website with the intention of giving up to date information about the Zofran lawsuit. Even though our advocates are not authorized to practice law in Hawaii, we are authorized to practice law in Delaware and we have offices there. Delaware is an important state to be able to practice law and have offices as that is where Zofran manufacturers have their main offices as well. This also means we can represent your suit when it is filed in Delaware state. For our Delaware office location, click here.
When you come to us to file your case, we treat your case with the greatest of care and do not offer a one size fits all manner of filing. Your case can be filed in Delaware State where we are licensed to represent you or it can be filed at another suitable location. In some instances we may advise that the case be filed in Hawaii while utilizing our local legal counsel contacts.
We understand that this is a difficult time for you and your family and we greatly encourage you to call us with any questions you may have. We are here to answer your questions and to speak with you at any time. Get to know our Zofran advocates here.
Where To Source Cleft Palate And Congenital Heart Abnormalities Info In Hawaii
Cleft Smile: http://www.cleftsmile.org/state-resources/hawaii/
Kapiolani Cleft and Craniofacial Center: https://www.hawaiipacifichealth.org/kapiolani/cleft
Cleft Palate Foundation: http://www.cleftline.org/parents-individuals/team-care/state-listings-h/