Various researches conducted by the medical community have associated the GlaxoSmithKline (GSK) drug, Zofran, with certain birth deformities. GSK has been noted as promoting Zofran, brand name Ondansetron, as a ‘safe’ anti-nausea drug for pregnant women to use when experiencing extreme symptoms of morning sickness. GSK never carried out sufficient studies that would qualify them to make the claim that Zofran is safe for use while pregnant.
One study conducted by CDC and researchers from Sloan Epidemiology Center analyzed data from 10,383 births, where 15.4 per cent of the pregnant women from that number were administered some form of Zofran to alleviate their morning sickness. They compared the remaining percentage of women who were not administered Zofran and those who were, and discovered that the 15.4 percentage of women who used Zofran for morning sickness in their first trimester, exposed their unborn baby to a 2.37 likelihood of being born with cleft palate. Read more about this study here. Already, there has been a lawsuit that was filed in Billings, Montana where a baby was born with cleft palate. According to the complainants the mother used Zofran during her first 12 weeks of pregnancy as she was suffering from severe morning sickness. Zofran is believed to be what caused the cleft palate as there is no known genetic history of such a defect in their family. To learn more about this suit go here.
Montana: Birth Defects Stats
American birth defect rates are documented at a rate of one in every 33 newborns is born with some kind of birth irregularity. For Montana specific birth defects visit montana.providence.org. Considering Zofran was open to the US market since 1991, it gained popularity as the go to drug for fighting morning sickness in expectant mothers, and its popularity helped it garner 99% of the market. The number of the total people living in Montana as of the most recent census data is 1,023,579.
The five Montana major cities based on population size are:
- Billings- 104,170 population
- Missoula- 66,788 population
- Great Falls- 58,505 population
- Bozeman- 37,280 population
- Butte- 34,190 population
Utilizing the information above of Zofran’s availability, market dominance and birth irregularity ratios, our attorneys have processed probable stats of Zofran affected births while also using the averaged hazard percentages noted in the clinical studies performed. We calculated that almost 580 newborns in Montana were born with birth irregularities due to their exposure to Zofran in utero in the first three months of their development.
Montana’s Probable Orofacial Cleft & CH Defects
When Zofran came onto the scene, it had three patents that managed to get Zofran to dominate the market through 2006. Generic versions of Zofran were also made available. Going by the ratios and estimations documented in medical community research studies, we believe there are roughly 580 birth defects in Montana that happened due to Zofran consumption in the early stages of fetal development. We further calculated how many of that number were cleft palate and how many were congenital heart defects (CHDs). The numbers were 146 defects that were a type of orofacial cleft and 434 CHDs. For Montana’s five major cities the defect figures break down as follows:
- Billings- probable total birth defects: 100 | probable orofacial cleft: 10 | probable CHDs: 90
- Missoula- probable total birth defects: 81 | probable orofacial cleft: 6 | probable CHDs: 75
- Great Falls- probable total birth defects: 77 | probable orofacial cleft: 5 | probable CHDs: 72
- Bozeman- probable total birth defects: 67 | probable orofacial cleft: 3 | probable CHDs: 64
- Butte- probable total birth defects: 66 | probable orofactial cleft: 3 | probable CHDs: 63
What Are The Known Abnormalities & Adverse Effects Linked To Zofran?
Despite the numerous accounts and studies that have been conducted and linked Zofran to certain birth abnormalities, the creators of the drug GSK, still deny that their it is a responsible factor. However, known abnormalities that have been documented in filed lawsuits have been:
- Cleft palate
- Cleft lip
- Renal dysfunctions
- Webbed toes
- Low set ears
- Heart murmur
- Facial dysmorphia
- Cardiac septum defects
- Atrioventricular septal defects
Montana Parents Looking For Ways To File A Lawsuit
This website is supported by various law firms located in different geographical locations. The website serves a purpose of being a constant supply of relevant and up to date information about the Zofran case. Although our Zofran advocates are not authorized to practice to law in Montana, we are authorized to practice law in Delaware. We also have offices in the state of Delaware.
When you are ready to file your lawsuit, we have several ways we suggest you file. Your lawsuit can either be filed in Delaware State where we have offices, and can fully represent you in a court of law. In Delaware is also where GSK holds its main offices. Alternatively, we may advise you file at a different location, or file your suit through our local trusted Montana counsel. Please call us and we will answer any questions you have. Our lawyers are here to speak with you at any time of the day. Get know our Zofran team here.