In order to have a drug approved by the US Food and Drug Administration (FDA) for use by the general public, it has to go through clinical trials that prove that the drug works to treat certain medical conditions, works as expected, and is safe to be used as directed. When the FDA is satisfied with the drugs safety and how it works, a drug label is created for the drug. This was the process that Ondansetron, also known as Zofran went through to have its FDA approved drug label in 1991. It was certified as a drug to be used by cancer and post-operative patients experiencing symptoms of nausea and vomiting due to their treatments.
However, Zofran has also since been associated with heightened incidents of birth defects like cleft palate and congenital heart defects due to its off-label usage as an anti-nausea drug for pregnant women afflicted with intense morning sickness. Off-label is also known as non-approved or unapproved drug use. In this case Zofran was being used in a different way other than its described FDA approved drug label.Although, the off-label use of drugs is legal it is not regulated in the US. Due to the lack of scientific evidence of Zofran being safe for use by pregnant women, there have been several medical studies conducted that have shown that the drug is not in fact safe for use while pregnant. Subsequently, there have been lawsuits filed against Zofran makers, GlaxoSmithKline (GSK), citing that their drug caused major infant birth defects.
Tennessee Child Birth Defects Records
The Tennessee health department website has vital statistics about the state’s birth defects. Nationally, the Center for Disease Control (CDC) reports that one in thirty three live births results in a birth defect. The population estimate for Tennessee is 6,549,352 as of 2014. Below are the numbers of Tennessee’s most inhabited places:
- Memphis- 653,450 population
- Nashville- 634,464 population
- Knoxville- 183,270 population
- Chattanooga- 173,366 population
- Clarksville- 142,357 population
Considering Zofran was accessible to the American public in 1991, it rapidly garnered a reputation for being the best drug to combat morning sickness and had a near 99 per cent stake in the market by 2005. With this information, our Zofran advocates have worked out the feasible stats of births where Zofran could have contributed to the birth irregularity, and in the process averaged the hazard quotas recognized in the medical studies conducted. Our estimations reveal that there are roughly 3,570 newborn births in Tennessee where Zofran ingestion in the early months of pregnancy led to a baby being born with an abnormality.
What Are The Recorded Probabilities Of Cleft Palate & CH Abnormalities Linked To Zofran In Tennessee?
We used the Tennessee population number of 6,549,352 in order to calculate the probabilities of how many birth abnormalities were a form of cleft palate and congenital heart defects. Our probabilities are 610 defects in the form of cleft palate and 2,960 babies born with CH defects. For Tennessee’s five largest cities our estimations give the following stats:
- Memphis- 360 newborn birth defects with approx. 65 cleft palate, and 295 CH defects
- Nashville- 350 newborn birth defects with approx. 62 cleft palate, and 288 CH defects
- Knoxville- 140 newborn birth defects with approx. 20 cleft palate, and 120 CH defects
- Chattanooga- 130 newborn birth defects with approx. 15 cleft palate, and 115 CH defects
- Clarksville- 120 newborn birth defects with approx. 17 cleft palate, and 103 CH defects
What Have Been The Conveyed Abnormalities And Unfavorable Effects Of Using Zofran?
The lawsuits that have come our way have seen complainants convey that Zofran was the agent that led to a child being born with serious birth abnormalities, after the mother had used Zofran to combat morning sickness in the first twelve weeks of pregnancy. These charges are based on the findings of several comparative medical studies undertaken all over the world. Some of the conveyed birth defects have been:
- Atrioventricular septal defect
- Ventricular septal defect
- Renal mutations
- Cleft palate
- Cardiac septum defect
- Webbed toes
- Low set ears
Tennessee Parents Researching Ways To File A Lawsuit
Zofranlegal.com was designed and funded by the law firms of Monheit Law, Janet Jenner & Suggs, Grant Eisenhofer, Markhoff & Mittman, and Banville Law, with the intention of the website serving as a stream for relevant and up to the minute Zofran related news. Our attorneys are not licensed to practice law in Tennessee, but we are licensed to practice law in the pivotal state of Delaware where we have offices, and also where Zofran manufacturers have their main offices as well. Our presence in Delaware is important because we are able to bring your case to court and legally represent you.
A lot of families from Tennessee that are of the understanding that their child’s birth abnormality was brought on by Zofran, have made contact with us via phone calls and contact forms. In all situations the mother had ingested Zofran in the first trimester of her pregnancy. With each case that comes our way we work out the best solution for you to file your case. We may find it best that you file your case in Delaware where we are licensed to practice law and have offices, or at a different location, or we may advise that you file your case in Tennessee utilizing legal counsel from our reputable network. Our lawyers are here to speak with you at any time of the day.
Please contact us to get more information and to have the questions you have answered. Meet our Zofran legal team here.
Relevant Cleft Palate & Congenital Heart Abnormalities Websites In Tennessee
Children’s Hospital Vanderbilt: https://www.childrenshospital.vanderbilt.org/services.php?mid=8698
Cleft Advocate: http://www.cleftadvocate.org/TN.html
TriStar Ashland City Medical Center: http://tristarashlandcity.com/hl/?/95945/Congenital-Heart-Defects-Center
Encyclopedia For Children’s Health: http://www.healthofchildren.com/C/Congenital-Heart-Disease.html