Can you sue a pharmaceutical company for birth defects?
Pregnancy brings many changes to a woman’s body. Some of these changes are welcomed, like healthier hair, fingernails and skin. Other changes are not so nice, with symptoms such as nausea and vomiting common—particularly in the first trimester. Some pregnant women seeking relief from these undesired symptoms turn to pharmaceuticals.
While some medications are already approved by the FDA to be used during pregnancy, others are not. The decision to use medication during pregnancy is one that must be made between a pregnant person and their doctor. Physicians often use the information that they have available from pharmaceutical manufacturers and current medical research to make informed recommendations for their patients.
What’s the harm in taking medication during pregnancy that hasn’t been approved for use by pregnant women?
Take the case of Zofran, which is a medication that has been used off-label without FDA approval for many years. Over time, reports have arisen that the medication is linked to causing birth defects and numerous lawsuits are pending against the parties that are responsible for suggesting its use among pregnant women.
Exploring the history of Zofran, along with the current status of lawsuits against its use in pregnant women, can help expectant parents make informed decisions for their health and baby during pregnancy. Those who have already had babies with birth defects can also benefit from seeing how the use of Zofran may potentially be linked to their child’s current health challenges.
What is Zofran?
Zofran, or rather its active ingredient called Ondansetron, is a drug that was approved in 1991 by the FDA as a treatment option for nausea and vomiting experienced by cancer patients who are undergoing specific types of chemotherapy. The medication works by blocking serotonin and improving the speed of gastric emptying.
The use of Zofran in pregnant women has risen in recent years as a way to combat the nausea and vomiting associated with “morning sickness.”
However, it is important to note that Zofran has never been approved by the FDA for use during pregnancy.
Rather, it is listed as a Class B drug, which explicitly means that it is untested for safety in pregnant women. Since there is no official testing by the FDA regarding the potential risks for pregnant women, it is referred to as using the medication “off-label” when a physician prescribes it during pregnancy.
Can Zofran cause birth defects?
Several studies have shown the potential link between Zofran and certain types of birth defects. The 2 most notable birth defects are cleft palate and congenital heart defects. The majority of the studies that have been conducted to this date have focused primarily on women who began using Zofran during their first trimester of pregnancy when the potential for developing birth defects is at its highest.
What does the history of Zofran lawsuits show?
Many medications that are safe for non-pregnant people have side effects that could pose a risk during pregnancy. Sadly, Zofran has a long history of lawsuits and research indicates that women need to be prepared for the possibility of birth defects if they take it while they are pregnant.
Looking at the timeline of legal action against GlaxoSmithKline can give you an idea of just how these concerns have been addressed in the past, along with where such lawsuits may be headed.
- 1983 — The only FDA-approved morning sickness drug—Bendectin—is removed from the market.
- 1984 — The number of women being hospitalized for morning sickness and vomiting doubles.
- 1991 — Zofran receives FDA approval for use in cancer patients to reduce nausea and vomiting during certain types of chemotherapy.
- 1999 — The FDA provides GlaxoSmithKline with an official warning letter for using marketing materials to promote Zofran in a way that is false or misleading.
- 2001 — Two former GlaxoSmithKline employees, Thomas Geraghty and Matthew Burke, allege that the company is promoting Zofran for off-label use to prevent morning sickness.
- 2003 —Burke and Geraghty file their whistleblower lawsuit regarding off-label use of Zofran in the U.S. District Court of Massachusetts.
- 2006 — GlaxoSmithKline loses the patent for the active ingredient of Zofran (Ondansetron) and generic versions receive FDA approval.
- 2012 — Harvard and Boston University researchers find that babies exposed to Zofran in the first trimester experience a 237% increased risk in developing the cleft palate.
- 2013 — The Justice Department resolves numerous claims against GlaxoSmithKline by setting a $3 billion settlement. Many of these allegations involved the off-label use of Zofran.
- 2015 — A mother in Minnesota files a Zofran lawsuit on behalf of her children who were born with congenital heart defects. Additional parents follow suit:
- On December 1, the U.S. District of Massachusetts consolidates more than 150 of these lawsuits.
- On December 11, GlaxoSmithKline files a motion to dismiss all of these lawsuits.
- 2016 — Judge F. Dennis Saylor IV allows the lawsuits to proceed.
- 2017 — More lawsuits are launched in both Federal and State courts.
As of today, allegations concerning the link between Zofran and birth defects are still being examined by the judicial system as medical researchers continue to assess the risk of off-label use of this drug.
What should you do if you took Zofran during pregnancy?
Women who took Zofran during pregnancy shouldn’t feel guilty for making what they believed was the right decision for their health at the time. Unfortunately, many women were not provided with all of the information that they needed to make an informed decision.
Drug manufacturers and healthcare providers must provide clear and accurate information to anyone who uses medications during pregnancy. Birth injuries and defects are traumatic for children and can have lifelong consequences. When you can’t turn back time, working with a lawyer to file a lawsuit can help you recover financially from the devastating effects of using Zofran during pregnancy.
Zofran lawsuit settlement amounts can range dramatically from one case to another, but they can help to cover medical costs, long-term care and the pain and suffering that a child endures as a consequence of their health challenges.
If you or someone that you know took Zofran during pregnancy and had a baby with a birth defect, then it is important to consult with a birth injury lawyer.
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- Hydrocephalus (Extra Fluid in the Brain Cavity)
- Cervical Dystonia
- Hemiplegia (Brain or Spinal Cord Injury)
- Hemorrhagic Stroke
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