Makers of the drug Zofran GlaxoSmithKline (GSK), were made aware in 1990 of two birth irregularities that their drug caused to expectant moms who had taken the drug as a remedy for intense morning sickness, also known as Hyperemesis gravidarum (HG). Initially, Zofran was approved by the Food & Drug Administration (FDA) for the specific use of nausea prevention in chemo, radiation therapy, and post operative patients. However, the makers of the drug went beyond the approved uses of the drug and marketed Zofran as an ‘off-label’ drug and offering negotiated bribes to medical specialists if they wrote scripts for their drug. Consequently, GSK resolved claims brought up by the US Government stating Zofran’s ‘off-label’ marketing and negotiated bribes violations, where the pharmaceutical company paid a hefty $3 billion fine.
The FDA never approved Zofran for anti-nausea use in pregnant women, and neither did GSK conduct suitable research to allow for their drug to be used in this manner. Zofran has further been linked with heightened chances of a baby being born with certain birth irregularities such as, but not limited to, hole in the heart defects and cleft palate. Please visit this page for more details about the clinical studies that have proven the side effects of taking Zofran during the first twelve weeks of gestation.
Birth Irregularities Stats In Florida
The Florida Birth Defects Registry (FBDR) contains detailed information about birth defects in children born in Florida since 1999. The recorded Florida population as of 2014 was 19,893,297. The state’s five most densely populated cities have the following recorded numbers:
- Jacksonville- 842,583 population
- Miami- 417,650 population
- Tampa- 352,957 population
- Orlando- 255,483 population
- St. Petersburg- 249,688 population
Zofran’s availability in the United States in 1991 saw the drug sky rocket in popularity that it most likely gained 99% market share by 2005. The CDC reports that there is one birth defect for every 33 babies born. Using this data our Zofran attorneys have worked out the likely figures of births where Zofran was a possible cause of a baby’s birth irregularity, by averaging the risk ratios proven in research studies that have been conducted. We have calculated that the probable figure is 9,300 births in Florida that have been affected by the use of Zofran in the early stages of fetal development.
Possible Calculated Cleft Palate & CHDs In Florida & Its Major Cities
While making use of the Florida population of 19,893,297, we are of the understanding that possibly 1,900 births are cleft palate and nearly 7,500 are congenital heart defects (CHDs) resulting from using Zofran in the first 12 weeks of fetal development. Using the afore reported population figures of the five major cities in Florida, we have calculated the following possible birth irregularities:
Jacksonville- 450 infant birth irregularities with a possible 150 cleft palate, and 400 CHDs
Miami- 250 infant birth irregularities with a possible 50 cleft palate, and 200 CHDs
Tampa- 215 infant birth irregularities with a possible 65 cleft palate, and 150 CHDs
Orlando- 170 infant birth irregularities with a possible 70 cleft palate, and 100 CHDs
St. Petersburg- 120 infant birth irregularities with a possible 20 cleft palate, and 100 CHDs
Current Documented Birth Irregularities Associated With Zofran
Despite the numerous lawsuits that have been filed against GSK and the birth irregularities that have been associated with their drug, GSK denies that Zofran is the cause of these stated irregularities. However, clinical studies and documented lawsuits state otherwise, and these are some of the reported birth irregularities that share a commonality of Zofran having been taken in the early months of pregnancy:
- Congenital heart defects (e.g. ASD, VSD)
- Low set ears
- Renal mutations
- Facial dysmorphia
- Supraventricular tachycardia
- Cleft Palate
As of August 2015 a Florida based family filed a lawsuit against GSK alleging that Zofran was a causal agent of their child being born with abnormalities.
Florida Parents Searching For Answers On ZofranLegal.com
Zofranlegal.com has been designed and financed by several law firms in order to provide relevant and timely news about the Zofran lawsuit. Even though our Zofran advocates are not authorized to practice law in Florida, we are authorized to practice and have offices in Delaware. Delaware is the HQ for Zofran manufacturers which makes it the ideal location for file a case against GSK. We are able to represent your case if it is filed in Delaware. For more information about our team, go here.
To date numerous families from Florida have reached out to us via contact forms and by calling us, as they are of the impression that their child’s birth irregularity was caused by Zofran ingestion in the early stages of pregnancy. We look at each case differently and depending on your situation we may advise you to file your Zofran lawsuit in Delaware or another applicable venue or we may suggest you file your case through one of our recommended local Florida counsel.
Please call us with any questions you may have about Zofran. Our lawyers are here to speak with you at any time of the day. Meet our Zofran team here.