Off-Market Labeling of Zofran
Off market labeling is when corporations “push” or encourage their product to be used for purposes in which it was not originally intended. Off market labeling is a corporate mechanism to increase profits for their product.
Much of the reasoning can be traced to the 12 year U.S. Patent Protection afforded by the FDA, which gives biotech or pharmaceutical companies 12 years of exclusive protection. However, after that time period generic manufacturers can produce and market such products.
As a result this 12 year window is used to maximize the market share for the product. This type of structure forces corporations who manufacture these drugs to take advantage of the time limited to them in order to maximize profits.
Consequently Zofran was originally manufactured to help avoid nausea. It was used to help with the effects of nausea after chemotherapy treatment or cancer related surgeries. Within a short period of time the off-market labeling of the product had started.
Within a short period of time Zofran was marketed to pregnant woman to help with the morning sickness and nausea related to pregnancy. However, what was not properly observed, discussed or researched was the impact the drug can have on the fetus. As a result significant birth defects started to occur from the use of Zofran while pregnant. In such cases those children, through their guardian will be able to pursue a claim for the damages sustained as a result of the exposure to Zofran.
Liability for Birth Defects
Who is liable for the injuries sustained by the use of Zofran? It is clear at this time that the manufacturer of the product, GlaxoSmithKline will have liability for the harm suffered. Generally, a manufacturer will have a duty to warn of the potentially harmful damage that can be caused by the use of their product. For example if you have ever seen a pharmaceutical companies commercials you will notice the warning at the very end. These warnings are broad and generally encompass all of the various ailements that can befall you, should you decide to use the product. However, with the use of Zofran it the pharmaceutical companies never warned of potential birth defect dangers. In fact Zofran was considered to not inflict harm on an unborn fetus. Generally, the FDA will classify certain drugs, which can cause reproductive harm in categories. These categories start from A through N, where A is the least damaging and N, which is considered to be the most harmful. Zofran was categorized as a B drug with regards to reproductive health issues. In other words it was safe without any positive findings that it would cause injury to an unborn fetus. Therefore, it is likely that the manufacturer will have exposure and liability for failure to property warn against the use of this drug for expecting or pregnant mothers. While manufacturers hold a degree of liability, the prescribing doctors equally share a degree of liability for the harm suffered by their patients. However, due to various statute of limitation issues it is not clear yet whether this route will be pursued.Common Injuries Associated with the Drug
Sadly Zofran users caused significant birth defects among their unborn children. In such cases many suffered serious birth injuries, which our firm is looking into. Here are a list of the various injuries we are currently considering.- Cleft Lip;
- Jaundice disease;
- Musculoskeletal injuries;
- Heart defects;
- Kidney defects;
- Fetal death;
- Fetal growth issues