There remains much to be learned about how Zofran causes birth injury defects in the heart such as Tetralogy of Fallot. In these cases there will be two evidentiary hurdles to overcome. First, the science must support that Zofran causes birth injury defects. Recent studies should help with that.
Zofran (ondansetron) is only approved by the FDA for treatment of nausea and vomiting among cancer and surgery patients. However, it is commonly prescribed off-label during pregnancy, resulting in a substantial portion of the annual sales for the drug over the past decade. So birth injury defect lawsuits may abound now we know about the dangers of Zofran. Minors usually have a number of years to bring Zofran birth injury defect lawsuits. Health insurance companies have guidelines requiring a diagnosis of hypernemesis before they will pay for the Zofran.
Many physicians assume that Zofran is safe during pregnancy, but several studies have highlighted potential Zofran birth injury defect risks when the medication is used in the first trimester. Hong Kong researchers in 2006, published a study that confirmed that Zofran crosses the placenta in significant amounts when taken by pregnant women, which is why it makes sense that if Zofran is toxic it could produce birth injury defects. Researchers concluded that the “developmental significance of this drug exposure requires further investigation,” yet millions of women have continued to be prescribed the medication without warnings about the potential Zofran birth injury defect risks.
These studies are critical to proving this first requirement of general causation. Also, in November 2011, a study published in the medical journal Birth Defects Research Part A: Clinical and Molecular Teratology concluded that women may be 2.37 times more likely to give birth to a child with a cleft palate following Zofran use. This may leave children with a severe facial deformity, which can occur when development of the fetus is affected during the first trimester. Additional studies have also identified potential Zofran birth injury heart defect risks. An August 2013 study that reviewed data on over 900,000 pregnancies in the Danish Medical Birth Registry found that children may be 2 to 4 times more likely to suffer a septal birth injury defect, involving holes in the heart, following Zofran exposure. More recently, a study published by the medical journal Reproductive Toxicology in October 2014 found there is a statistically significant increased risk for certain birth injury heart defects with Zofran use early in pregnancy.
So assuming these studies prove general causation, there must be evidence of specific causation of the birth injury defect. This means that the scientific method must be employed to show that your baby’s birth injury defect was caused by the Zofran. Certain of the birth injury defects, like Tetralogy of Fallot, existed long before Zofran was ever prescribed. Some may remember the movie “Something the Lord Made.” The physicians there attacked the congenital heart defect of Tetralogy of Fallot, also known as Blue Baby Syndrome, and they open the field of heart surgery. Blue Baby Sydrome can come from a random genetic mutation. So, to prevail on one of these Zofran birth injury claims of Tetralogy of Fallot ordinarily the random occurrence must be ruled out and Zofran as the cause ruled in.
Another aspect to these cases is what in some jurisdictions is called the learned intermediary doctrine. As it pertains to Zofran causing birth injury defects, the doctor who prescribed the Zofran must testify that s/he would not have prescribed the drug had they known it could cause birth injury defects. While this sounds easy, it is not. The Zofran birth injury defect litgation is in in its infancy and critical to the success of these cases will be when did GlaxoSmith Kline know of these dangers of birth injury and what did they know. Then, this proof can be provided to the doctor under circumstances.
If you or a loved one took Zofran while pregnant, and your child was born with a birth injury, and would like to talk with me, a birth injury lawyer in Chicago, please call me now at (312) 637-9141 or contact me now.