During pregnancy, many women experience various unpleasant symptoms. Nausea and vomiting are two examples. In some cases, the symptoms are so severe that it can become difficult to eat, work, and carry out other activities of daily living. Doctors often prescribe Zofran to provide some measure of relief. Many women who chose to take this medication during their pregnancies were told that it was safe for themselves as well as their unborn children. Unfortunately, studies have since linked used of the drug with several types of birth defects.
Allegations Made Against the Maker of Zofran
Zofran is a medication made by GlaxoSmithKline (GSK) that was approved by the U.S. Food and Drug Administration (FDA) to help cancer patients suffering from nausea as a result of treatments or surgery. The drug maker also marketed the drug for use by pregnant women suffering from morning sickness. However, Zofran was never actually approved by the FDA for use during pregnancy. Many lawsuits are now being pursued against GlaxoSmithKline. The allegations made against the company include the following:
- The company had a duty to ensure that Zofran was safe before it began offering the drug to the public.
- The company had a duty to determine the risks associated with the drug’s use before marketing and selling it.
- The company produced a defective drug.
- The company failed to provide adequate warning to the public about dangerous side effects linked to Zofran use.
- The company advertised Zofran as being a safe and effective way to treat morning sickness and hyperemesis gravidarum even though it had not been FDA approved for that use.
- The company misrepresented the studies that were done that showed it was safe. In actuality, the study results reportedly showed abnormal bone growth and signs of toxicity.
- The company failed to properly evaluate all of the data and safety information on Zofran use by pregnant women.
- The company allegedly paid doctors to prescribe the drug to pregnant women.
In 2012, the company pleaded guilty to federal charges of fraud and the illegal promotion of Zofran and other drugs. The company was forced to pay a $3 billion in a legal settlement as a result. Court documents show that GlaxoSmithKline has known for over two decades that Zofran presented an unreasonable risk of harm to developing babies when taken by pregnant women. Despite having this knowledge, the company continued to promote its use.
Birth Defects Linked to Zofran Use by Pregnant Women
Nausea and vomiting are common problems among pregnant women. In some cases, the symptoms are so severe that they can result in malnutrition in the mother and the unborn baby. Women who took Zofran to treat their symptoms believed that the medication would keep their babies safe from this complication. Instead, some babies suffered birth defects. The potential harm done to developing babies when their mothers take Zofran during pregnancy is significant. Examples include the following:
- Heart defects
- Cleft lip
- Cleft palate
- Club foot
- Skull deformities
In some cases, the birth defects caused by Zofran use during pregnancy are so severe that the children will require a lifetime of care.
Steps to Take After a Birth Defect Caused by Zofran Use
If your child suffered birth defects as a result of your Zofran use during pregnancy, it is important to take the proper steps to protect your legal rights. The following is an overview:
- Contact an experienced attorney. It is important to seek legal representation in order to protect your legal rights as well as the rights of your child. It is also important to be aware that there are time limitations on your ability to file a claim against the drug’s manufacturer, so time is of the essence.
- Gather your medical records from the time period during your pregnancy. It is important to have a timeline and supporting information relating to your Zofran use.
- Gather all of your child’s medical records. These records should show the various dragonesses your child has received, the treatment that was administered, and the prognoses provided by the medical team involved.
- Keep accurate records relating to the expenses that you have incurred as a result of your child’s birth defects that are attributed to Zofran use during pregnancy.
Protecting your legal rights after Zofran use is important, as compensation may be necessary to help pay for treatment and to address the pain and suffering that you and your family may experience. We encourage you to contact us today to begin the process at 855-947-0707.