- Flynn vs. GSK: In 2015, Flynn won the case against GSk and recovered monetary damages for the disabilities and disfigurement of her child.
- Davis vs. GSK: The court awarded damages to the plaintiff for the cleft lip and palate caused by Zofran in the plaintiff’s child.
- Kutzer vs. GSK: The court decided in favor of the Kutzer’s, and granted them compensatory damages.
- LeClair vs. GSK: The congenital disabilities caused by Zofran were proven in court and LeClair was compensated for the suffering and medical expenses.
- Parents and mothers who took Zofran during their pregnancies and whose babies were born with congenital disabilities, such as:
- Cleft Lip and Palate
- Atrial Septal Defect
- Ventricular Septal Defect
In the early 2000s, GlaxoSmithKline, a British multinational pharmaceutical company, came under fire for the production and distribution of a drug, prenatal exposure to which caused congenital disabilities in babies around the globe.
GlaxoSmithKline, or GSK, is a household name worldwide. Ranked as the seventh-largest pharmaceutical company in the world, GSK is the manufacturer of some of the most common, everyday drugs like Augmentin, Advair, and Lovazo. GSK not only produces drugs, but it also manufacturers various everyday household items, and some of their popular brands include Sensodyne and Horlicks.
In 1991, GSK got FDA’s approval to distribute a drug called Zofran, which went on to become a top-seller for nausea, vomiting, and morning sickness, earning GSK billions of dollars.
Zofran is the brand name for ondansetron, the active compound in the drug. Developed and patented in 1991, it belongs to the drug class of serotonin 5-HT3 receptor antagonists. In layman’s terms, ondansetron works by blocking the action of serotonin, a hormone that is responsible for feelings of happiness in people but is also guilty of causing the feelings of nausea and vomiting.
Zofran was marketed as a preventative treatment for nausea and vomiting after cancer chemotherapy, radiation therapy, and post-surgery. It was meant to be taken by the patient orally before surgery to avoid the unpleasant experience of nausea and vomiting that accompanies most surgeries and intense medical treatments. Common side effects were listed as headaches, dizziness, constipation, fatigue, and diarrhea.
Thus, Zofran was essentially used to prevent post-treatment nausea and vomiting in patients who:
- Were going through emetogenic cancer chemotherapy
- Were going through radiation therapy
- Underwent any surgery
Zofran, or ondansetron, is contraindicated in patients who:
- Have hypersensitivity to ondansetron or any other compound of the formulation
- Are being administered concomitant apomorphine for hypotension and unconsciousness
Doctors eventually started prescribing Zofran, as a solution for morning sickness in pregnant women to ensure that the mothers and the babies stay hydrated. Though Zofran was not originally meant for this purpose, GSK never issued a warning to caution pregnant women about the potential harm that Zofran could cause to the fetus, nor did it investigate the effects of Zofran on developing babies, despite knowing that the drug was being recommended to expectant mothers to fight against morning sickness.
In 2015, the first lawsuit against Zofran was filed, claiming that the GSK’s Zofran, that mothers took for their morning sickness during their first trimester, had caused their babies to be born with obvious congenital disabilities, including defective cleft palates, abnormal heart rhythms, and ‘hole in the heart’ defects. Several other lawsuits by distressed and angry parents followed, blaming GSK for the disabilities of their babies. There have been many studies over the years studying the consequences of Zofran and the correlation between disabilities and the drug, and evidence has come to light that supports the claims that Zofran does indeed cause an increased risk of congenital disabilities in the children of mothers who took Zofran during their pregnancies, especially during the first trimester, as that is the time the fetus is the most vulnerable.How does Drug Work?
Zofran is available both as a disintegrating tablet and as an oral solution. With side effects as mild as headaches and upset stomachs, Zofran seemed to be the perfect medication to avoid the nausea that comes with surgery and certain treatments.
Zofran is grouped in with a class of medicines known as serotonin 5-HT3 receptor antagonists, or serotonin blockers. They are usually prescribed for the treatment of postoperative nausea.
Serotonin is a chemical naturally produced by human bodies. Popularly known as the ‘happy hormone,’ the level of serotonin in the body is what causes mood swings, anxiety, and euphoria. However, serotonin production causes a person to feel nauseous. The levels of serotonin rise in the stomach to push out unpleasant or upsetting food through diarrhea. The blood levels of serotonin rise too, stimulating the part of the brain that causes nausea.
Zofran is a serotonin antagonist and works by blocking the serotonin receptors in the chemoreceptor trigger zone (CTZ), located on the blood-brain barrier. It is also part of the vomiting center. The CTZ communicates with the vomiting center to induce vomiting when high levels of serotonin are detected in the blood. When these serotonin receptors are blocked, the communication between the brain and vomiting center is decreased, causing fewer instances of nausea and vomiting.Uses of the Drug
The drug was basically designed to treat nausea in very specific patients. Zofran was supposed to be taken by people who were undergoing cancer treatment, radioactive therapy, or any surgery that might bring on extreme nausea later. The dosage and instructions were defined for each type of patient, complete with how long before treatment they were supposed to take it. The three major targets were:
People undergoing high emetogenic cancer chemotherapy were required to take Zofran before starting chemotherapy sessions. The therapy is harsh and often induces extreme nausea that Zofran helped to avoid.
Also a treatment option for cancer patients, radiation therapy involves using high doses of radiation to kill cancer cells and tumors. The treatment, like chemotherapy, is very hard on the patients and is followed by an onset of extreme nausea and vomiting episodes.
A lot of major surgeries can trigger nausea and vomiting in patients. To avoid vomiting and becoming dehydrated, Zofran is often prescribed to patients post-surgery to help them keep hydrated and deal with the symptoms of post-operative stress.
While the drug wasn’t intended to be used for anything else, it was found to effective for pregnant women who were dealing with morning sickness.
Eventually, it became one of the most prescribed medicines for morning sickness, and pregnant women took it to avoid the unpleasant feelings of nausea and vomiting every morning. GlaxoSmithKline not only failed to warn consumers but instead marketed it as an off-label remedy for morning sickness, which made doctors prescribe it to patients.Congenital Disabilities Caused by Zofran
No mother would knowingly put her baby at risk, knowing that her intake of a drug could cause lifelong defects and abnormalities in her baby, often even leading to death. While GSK was aware that pregnant women were taking Zofran to cure morning sickness, it failed to warn people of the adverse or even unknown effects of Zofran on pregnant women and fetuses.
Instead, they chose to cash-in on the opportunity until the lawsuits started hitting them. The most common types of congenital disabilities caused by Zofran and those that are known include:
- Cleft Lip / Cleft Palate: One of the most common congenital disabilities in newborns is the cleft lip and palate. These are splits in the upper lip and are produced as a result of facial structures not forming properly in a developing fetus. It usually occurs in babies whose mothers consumed alcohol, smoked cigarettes and took certain medications during their pregnancies. Unfortunately, one such medication is Zofran. Cleft lips and palates are immediately identifiable at birth and can be corrected via multiple surgeries.
- Heart Murmurs: Heart murmurs are sounds that are made by the abnormal flow of blood in and around your heart. While heart murmurs themselves are not a disease, they may indicate underlying heart problems. Tests need to be done to ascertain if the murmurs are caused by a serious heart problem, which then needs to be treated accordingly.
- Atrial Septal Defect (ASD): ASD is what is commonly referred to as ‘hole in the heart.’ It is a congenital problem that occurs as a result of the upper chamber of the heart (atria) not closing properly. It manifests itself as a gap between the walls. Small holes tend to close by themselves during infancy, but larger holes need to be operated on to be corrected. If left untreated or undetected, ASD can increase the chances of the baby having a stroke, heart failure, arrhythmias, and a shorter life span than other healthy babies.
- Ventricular Septal Defect (VSD): VSD is also what causes the ‘hole in the heart’ condition. VSD is similar to ASD, with the difference being that it is the lower chambers of the heart that do not close properly in VSD, causing the hole. A large VSD may result in a person’s pure blood supply mixing, which causes the heart to work faster.
It should be noted that these are just some of the complications that we know of. Studies are still being conducted to ascertain what other effects the drug can have on fetuses and pregnant women. A lot of contrary studies have also come out. Two separate Danish studies reviewing the effects of Zofran reported two completely different results. While one said that Zofran has no major, long-term effects on babies, the other concluded that there is almost double the chance of Zofran causing heart defects in babies.
While nothing is conclusive, there are more studies indicating the adverse effects of Zofran on fetuses than there are claiming that it is safe. There might be many more defects that might come to light as studies progress; it is best to be safe and use alternative medicines, if needed, during pregnancy.Who Can File a Zofran Lawsuit?
The parents of a baby born with congenital disabilities are eligible to file a lawsuit against GSK if they notice any of these complications in the baby, and the mother was known to have been taking Zofran to cure her morning sickness during the pregnancy. Common congenital disabilities caused by Zofran are listed below:
- Cleft Lip and Palate
- Atrial Septal Defect
- Ventricular Septal Defect
Other heart complications, weaknesses, and disabilities should also be noted, as they might possibly be the result of Zofran as well.
Consult a doctor immediately after the birth of your baby. If they report any abnormalities, let your doctors know about the usage of Zofran throughout the pregnancy, and discuss whether the complications and defects might have any link to that.
If your doctor concedes that Zofran might be the possible culprit for the baby’s congenital disabilities, speak to a lawyer about your options in bringing a claim or a lawsuit. At Frankl & Kominsky, we have a host of injury attorneys who can help assist you and strive to get the justice and settlement you deserve.How Long Do I Have to File a Zofran Lawsuit?
If a child is born with congenital disabilities and the mother was prescribed Zofran to help with morning sickness during pregnancy, especially the first trimester, that mother can file a case against GSK. It’s best to keep a record of the birth defects as soon as you become aware of them. For this, you need to get a thorough medical examination done for the child. Even if the symptoms don’t show up immediately, report them as soon as they start becoming apparent. Ask your doctor if it could possibly be because of prenatal exposure to Zofran.
Do not wait too long to file a lawsuit. The Statute of Limitations will vary from state to state, however, we encourage you to contact our seasoned injury lawyers to assist you with filing a class action lawsuit against GlaxoSmithKline.
Once the Statute of Limitations expires, your lawsuit will likely be dismissed and you may be barred from bringing your claim. Make sure you know just how much time you have. Talk to your lawyers about this; they can better explain the Statute of Limitations in your specific state.How Many Lawsuits Have Been Filed Against the Drug Manufacturer?
In 2003, two former employees of GSK came forward against GSK, revealing the actions of the company and provided evidence as to how they were aware of the potential harm that Zofran could cause to fetuses. They also claimed that despite being aware of the risks, GSK still marketed the off-label use of the drug. The two whistle-blowers, namely Thomas Geraghty and Matthew Burke, became essential players who led the government to probe in further, alert the public about the potential harm in taking Zofran, and in 2006, caused the pharmaceutical to lose its patent on Zofran’s active ingredient, ondansetron.
While the whistle-blower lawsuit did trigger several studies into the matter, the FDA did not ban the drug from the market because of the lack of definitive evidence. The studies still showed contradictory results. However, in 2013, the government announced a settlement amount of $3 billion, which GSK accepted, to settle various claims against the company, including the illegal, off-label marketing that was disclosed by former employees of GSK.
Flynn vs. GSK
In 2015, the first lawsuit was filed against GSK by a consumer. A mother in Minnesota filed a Zofran lawsuit, claiming that her use of Zofran during her pregnancy caused both of her daughters to be born with congenital heart defects. Cheri Flynn, the mother, claimed that had she been adequately warned, she would never have resorted to taking Zofran. Her children had stunted growth and development and needed constant monitoring and surgeries when they were younger.
LeClair vs. GSK
Four days later, Tomisha LeClair filed a Zofran lawsuit, too, blaming GSK for the congenital disabilities of her child. She stated that she used the medication to treat her morning sickness early on in the pregnancy. In 2000, her child was born with severe deformities, including serious heart defects, facial dysmorphia, hearing loss, and other congenital disabilities that took tens of surgeries and more than a decade to correct.
Kutzer vs. GSK
Angela and Brian Kutzer filed a lawsuit, claiming that their son’s deformities caused by Zofran may impact his ability to ever have children. The couple accused GSK of prescribing the medication for morning sickness, under false impressions of its safety.
Davis vs. GSK
Ashley Davis and her husband filed a lawsuit against GSK, blaming Zofran, which Ashley was prescribed during her initial trimester of the pregnancy, for causing cleft lip and palate in their child, which caused him to experience a delay in his speaking abilities and psychological developments.
At the end of 2015, multiple lawsuits poured in against Zofran, GSK filed a motion for the court to dismiss the cases related to Zofran. In early 2016, a judge rejected the motion and allowed the lawsuits to proceed and the families to get the justice and compensation they deserved.Hire a Personal Injury Lawyer to File a Zofran Lawsuit
At Frankl & Kominsky, our injury attorneys have recovered more than $75 million in accident and injury settlements. If your child is born with any of the aforementioned congenital disabilities as a consequence of the mother using Zofran during pregnancy, we can try to help you recover compensation for past and future medical bills, and special damages.
In cases where the aforementioned diseases have resulted in your child’s death, we can try to get you the compensation that you deserve through a wrongful death claim against GlaxoSmithKline, while you recover from the grief.
We understand that this is a tough time for you, and we do anything in our power to make the filing process easier for you. We offer a contingency based fee. You can get a free case evaluation from our experienced injury lawyers today and get valuable advice on how to move forward with your Zofran lawsuit and try to hold those responsible for your child’s congenital disabilities accountable.