The FDA (Food and Drug Administration) approved the anti-nausea and anti-vomiting drug Zofran for cancer patients who have undergone radiation therapy, chemotherapy, and surgery. However, some doctors prescribe the GlaxoSmithKline medication to expectant mothers suffering from morning sickness (nausea gravidarum) as an “off-label” use against FDA recommendations. Since 2015, hundreds of plaintiffs have filed Zofran lawsuits against the drug manufacturer claiming the medication caused their child to be born with congenital disabilities. These families are seeking financial compensation to recover their damages.
Rosenfeld Injury Lawyers LLC represents victims of defective medications who were harmed or gave birth to a child with congenital disabilities. Our law firm has successfully prosecuted cases for our clients who have significant damages after taking a bad drug. Our attorneys are available to answer any legal questions on how to receive the monetary compensation you deserve if your injuries were a result of someone else's negligence. Should you have additional questions, we invite you to contact our office for a free review of your legal rights.
Receiving Financial Damages
The amount of financial compensation your family can receive is dependent on your unique circumstances involving the injuries and damages in your case. However, our attorneys work to ensure you receive adequate monetary recovery that includes:
- Hospitalization bills
- Medical expenses
- Cost of future surgeries, treatment, and therapies
- Lost wages if one or both parents need to quit working to attend to the child's needs
- Non-economic damages including pain, suffering, mental anguish, emotional stress, and grief
- Loss of enjoyment of life and loss of companionship
- Funeral costs and burial expenses in wrongful death cases
The History of Anti-Nausea Medication
For years, Bendectin was the only available FDA-approved anti-nausea medication for the treatment of morning sickness (nausea gravidarum) in America. In 1983, the drug was removed from the medical marketplace. The following year, the incident rate of pregnancy-related hospitalizations involving severe vomiting and nausea doubled.
By 1991, the FDA approved Zofran as an anti-nausea and anti-vomiting medication. However, the federal agency only allowed the medication to be prescribed to cancer patients who were currently receiving chemotherapy, radiation therapy, or to treat nausea associated with surgery. It was not too long before doctors began prescribing the medication to expectant mothers who are suffering from morning sickness because it was the only available drug on the market.
In 1999, the FDA released a warning letter involving Glaxo SmithKline and their illegal promotional material that contained misleading or false information involving Zofran. Two years later in 2001, Zofran sales in America totaled more than $850 million. That same year, the drug maker began seeking promotion of Zofran for “off-label” use to treat nausea gravidarum (morning sickness). The following year (2002), American Zofran sales increased to $1.1 billion.
By 2003 two whistleblowers filed a lawsuit in the US District Court of Massachusetts claiming Zofran was illegally promoting the product for “off-label” use. Three years later (2006) Glaxo SmithKline lost the Zofran patent allowing other pharmaceutical manufacturers to make generic versions of the medication. The FDA approved ondansetron, the first generic version of Zofran through their fast-track program.
By 2011, the FDA began issuing safety communication warnings to alert patients and doctors of the serious side effects associated with taking Zofran (ondansetron). By 2015, many families began filing lawsuits against the drug manufacturer, basing their case on the serious side effects of using the drug including birthing children with severe congenital disabilities.
Government Warnings and Safety Communications
In 2012, the US Department of Justice accepted a settlement agreement with Glaxo SmithKline to resolve their lawsuit for $3 billion. This suit claimed that the drug manufacturer illegally marketed many of its medications for “off-label” use including Zofran for expectant mothers for the treatment of morning sickness (nausea gravidarum). The Justice Department proved that the drug maker had paid doctors kickbacks in exchange for prescribing Zofran to pregnant women even though they knew it could cause serious health consequences to the fetus including the development of congenital disabilities.
The government was concerned that doctors were prescribing Zofran but never took action to change its classification of the drug as a “Pregnancy Category B” medication. This classification means that no adequate or well-controlled research studies have identified the safety and efficacy of Zofran use by pregnant women. In fact, all the available fetal safety research data had been gathered on no more than 200 births.
Glaxo SmithKline had initially conducted a preliminary research study in the 1980s that revealed that Zofran had crossed the placenta in test animals. Since then, other studies have verified that the medication is known to pass rapidly from the human mother to the fetus in “significant amounts.” Unfortunately, the medication remains active in the fetus' bloodstream and body tissue much longer than in the mother.
In the months after this study was initially published, other researchers took the same information and got different pregnancy outcomes. Their results showed that women taking Zofran (ondansetron) were twice as likely to birth a newborn with a heart disability. Their research revealed that babies whose mothers had taken Zofran (ondansetron) in their first trimester had a 30% overall increased risk of developing a congenital disability.
As a result, proximally 5% of newborns that had been exposed to the drug were born with a congenital disability. This statistic s significantly higher than the 3.5% of newborns who were never exposed to the medication.
Building a Case for Compensation
Many attorneys working on behalf of their plaintiffs have filed Zofran lawsuits against the drug maker claiming that medication has caused significant health problems after expectant mothers took the drug during their first trimester. In all these cases, their doctors had prescribed the pregnant women Zofran (ondansetron) to treat their severe nausea and vomiting. However, the physicians never discussed the known severe complications that the drug could create because they did not know of the severe consequences or had been receiving financial kickbacks from the drug maker. Many of these children were born with:
- Skilled Deformity
- Organ malformation
- Musculoskeletal Abnormality
- Kidney Malformation
- Cleft Palate
- Cleft Lip
- Restricted Fetal Growth
- Fetal Death
- Heart Defects including:
- Atrial Septal Defect (ASD) – Newborns exposed to Zofran (ondansetron) can develop a “hole in the heart” atrial septal defect where the blood passes between the heart's upper two chambers (atria). Without treatment, the defect can eventually cause fatal lung damage and reduced bloodstream oxygen levels that could be life-threatening.
- Ventricular Septal Defect (VSD) – This condition causes the development of a hole between the heart's two lower ventricles (chambers). While this condition is rare, it can develop with ASD in the same heart.
- Heart Murmur – Doctors often diagnose heart murmurs by the abnormal sound when using a stethoscope to listen to the baby's heart. Different heart defect conditions produce different sounds.
These Zofran lawsuits are based on the company's unlawful and fraudulent promotion of the drug to treat morning sickness (nausea gravidarum) even though the medication had not been approved by the FDA. The documents also allege that the drug maker hid evidence of the known risks of the medication and failed to warn doctors and patients about those risks. Some of the language in the file documents reveal that:
- The drug maker had a legal responsibility to ensure that the medication was safe before it was offered to the public but failed to identify known safety risks before offering it on the medical marketplace.
- The pharmaceutical manufacturer failed to warn consumers of the dangers, and potentially fatal, side effects even though they had known about these potential risks for years.
- The drug manufacturer promoted the medication as a safe and effective treatment for morning sickness (nausea gravidarum and hyperemesis gravidarum) although the FDA never approved the medication for this specific use.
- The pharmaceutical company misrepresented the drug by showing animal studies that prove that the medication was safe when the truth shows that there were signs of toxicity in abnormal bone growth.
- The drug maker failed to evaluate research data properly or provide necessary safety information that showed how pregnant women should not take Zofran because of known, often fatal, side effects.
- The drug maker designed, manufactured, promoted, marketed, and sold a defective medication knowing the potential risks it caused expectant mothers and fetuses.
- The pharmaceutical manufacturer fraudulently and falsely claimed that their medication was safe to treat morning sickness (nausea gravidarum) when knowing it was not.
Zofran Lawsuit Settlements
As of now, Glaxo SmithKline has not made any significant settlement offer to a group of patients affected by Zofran with the hundreds of patients who have suffered severe injuries from the drug's side effects. Also, many of the early cases against the drug manufacturer citing congenital disabilities are still in the initial stages. Many of these original cases were consolidated in MDL (multidistrict litigation) court in the US District of Massachusetts that will soon be heard in bellwether trials to determine how future jurors will resolve the hundreds or thousands of other lawsuits filed in federal court.
Therefore, while it is easy to say that if you or your child was injured because of the drug, you should be able to recover. It is not easy to say how much, and you will not be able to grab from a large settlement pot because that does not exist right now. Whether you have a case or not must be determined by its own circumstances. These cases are very complicated and time-consuming. You should speak personally with an attorney about the potential for a case, the mechanics of bringing it to trial, the costs involved, the time it will take, and the chances of recovery.
Hiring an Attorney
The bad drug injury attorneys at Rosenfeld Injury Lawyers LLC understand that suffering an injury after taking a defective medication was not your fault. We fight aggressively on behalf of our victims to hold pharmaceutical companies financially accountable for their negligence. Our attorneys have successfully obtained millions for our clients and their family members to ensure they were adequately compensated to cover their medical expenses, household bills, lost wages, loss of future earnings, pain, suffering, and emotional damage, and we can help your family too.
Our legal team encourages you to contact our attorneys today to schedule a free, no-obligation case consultation to discuss the merits of your monetary recovery claim. We accept all personal injury cases, wrongful death lawsuits, and defective medication injury claims through contingency fee arrangements. This legal contract postpones the payment of legal services until after we have successfully completed your case through a negotiated settlement or a jury verdict.
Our law firm gets results quickly because we understand you need money now. We probably offer every client a “No Win/No-Fee” Guarantee, meaning if we are unable to secure financial compensation on your behalf you owe us nothing. All information you share with our law office will stay confidential.
For additional information see the following pages:
- Why were pregnant women prescribed Zofran?
- What types of birth defects in children have been associated with Zofran usage?
- Has the FDA issued any warnings concerning the use of Zofran during pregnancy?
- Has there been a recall of Zofran from the market?
- Have there been any lawsuits filed against the manufacturer of Zofran related to birth defects in children?
- If I took Zofran during my pregnancy and my child was born with birth defects, can I file a legal claim or lawsuit to recover compensation for their injuries?
- Are there any time constraints for pursuing a lawsuit related to Zofran-birth-defects?
- What must be alleged in a Zofran lawsuit in Federal Court?
- If a took a generic version of Zofran, can I still pursue a legal claim for damages related to my child's birth defects?
- Are there any class action lawsuits against GlaxoSmithKline, the manufacturer of Zofran, for children who have birth defects following Zofran usage during pregnancy?