Ondansetron, the generic form of Zofran, is a 5-ht3 antagonist medication prescribed by doctors to treat vomiting and nausea. The Food and Drug Administration (FDA) has approved the drug to be used concurrently with chemotherapy, radiation treatment, and some surgical procedures. However, there are significant problems with Zofran and its generic form ondansetron that has caused serious side effects, leading to plaintiff's filing a lawsuit for childbirth defects. Some doctors prescribe Zofran or ondansetron to pregnant mothers as an “off-label” medication treatment for morning sickness.
Rosenfeld Injury Lawyers LLC represents families who have been affected by the harmful properties of Zofran and ondansetron. We have filed hundreds of lawsuits on behalf of our clients in cases involving bad drugs, professional negligence, and product liability. Our law firm has successfully prosecuted cases where drug manufacturers were found to be responsible for causing congenital disabilities. Our attorneys are available to answer any legal question on how to receive the monetary compensation your family deserves if your child was born with a disability caused by the negligence of others. Should you have additional questions, we invite you to contact our office for a free review of your legal rights.
Does GlaxoSmithKline Make Ondansetron?
GlaxoSmithKline (GSK) developed Zofran in the 1980s and has marketed the drug since its approvalby the FDA for the treatment of nausea and vomiting in cancer patients receiving treatment. The pharmaceutical manufacturer maintained exclusive rights to market and sell the medication between 1991 and 2007 before the expiration of their relevant patents. Since then, several other drug makers have manufactured and marketed numerous generic versions, including ondansetron.
While the initial approval by the Food and Drug Administration for GlaxoSmithKline's drugs was extensive, generic makers have since received drug approvals through a relatively simple process. These drug manufacturers applying for an ANDA (Abbreviated New Drug Application) had established that Zofran and their new generic medication are identical in how it is administered, its strength, dosage amount, active ingredients, and recommended use as stated on the label.
The government agency can then approve the drug maker's application by claiming ”ondansetron is the same as Zofran.” The FDA mandates that the drugmaker will continue to make, promote, and market the ingredients, dosage, and strength of the medication without alterations.
Since the FDA approved ondansetron for sale in 1991, approximately 50 generic drug manufacturers have received ANDA approval to make and sell their generic version of Zofran with the same ingredients and dosage. Unfortunately, there is no difference between Zofran and ondansetron in the serious side effects it causes patients, especially expecting mothers who took the drug.
Within a couple of years after GlaxoSmithKline introduced Zofran to the medical marketplace many patients started some filing lawsuits against the drug manufacturer concerning off-label marketing. Many of these plaintiffs had suffered serious complications, especially mothers who have given birth to babies with congenital disabilities. Since then, others have filed lawsuits against pharmaceutical companies that manufacture ondansetron, citing identical problems with the Zofran generic medication.
While any doctor can use their best judgment when prescribing medications for nearly any off-label use, the pharmaceutical manufacturer is not allowed to market their products to be used “off-label.” Promoting the drug for use in treating a condition other than those listed on the label is illegal. Many of the mothers who filed lawsuits against Zofran and ondansetron drug makers claim that their newborn suffered severe congenital disabilities including:
- Skull deformity (craniosynostosis)
- Cleft lip and cleft palate
- Kidney malformation
- Congenital heart defect
The United States DOJ (Department of Justice) filed a lawsuit against Zofran maker GlaxoSmithKline claiming that the pharmaceutical company marketed their product fraudulently for off-label use. In 2012, the federal government won their case the pharmaceutical giant that was found guilty of numerous civil infractions including paying doctor's kickbacks to promote the drug for off-label use. The company was ordered to pay $3 billion in criminal and civil fines. Since then, many plaintiffs who were pregnant and using the drug filed lawsuits against the company.
Drug-Induced Birth Defects
In February 2013, the New England Journal of Medicine published data from a study of the discovered links between Zofran (ondansetron) and congenital disabilities. The data involved 900,000 pregnancies over 13 years from 1997 through 2010 of expecting mothers in Denmark. The researchers concluded that there was no association between the medication and the development of congenital disabilities. However, other research data has since disputed these conclusions.
Other studies involved the same data but was collected over a longer period of time and included more pregnancies. The study results were published in August 2013 that showed a correlation between Zofran (ondansetron) and a 200% increased risk of a fetus developing heart defects. The research also concluded that there was a 30% increased potential risk of a fetus developing other congenital disabilities if the mother took the dangerous medication. The study showed that 4.7% of the 1240 women taking Zofran or ondansetron during the first three months gave birth to a baby with a congenital disability. This percentage was significantly higher than the 3.5% of pregnant women who did not take the medication.
Another study has been published since 2010 showing that significant amounts of both the brand-name and generic form of Zofran can pass through the placenta into the fetus rapidly. The study revealed that the medication tends to remain active much longer in the fetus compared to how long the drug remains in the mother's bloodstream.
A Harvard Study
In January 2012, researchers from Boston University and Harvard University published an article in the journal Birth Defects Research. The report “Medications Used to Treat Nausea and Vomiting of Pregnancy and the Risk of Selected Birth Defects” was based on a comprehensive review of popular morning sickness treatments and the potential dangers involving harm to the fetus.
The team of researchers used hospital records and patient interviews to identify an incident rate of cleft palate in newborns. Their research showed a significantly higher rate of this congenital disability in babies whose mothers took prescribed Zofran or ondansetron compared to women who did not. The study revealed that there was a 237% higher possibility of delivering a baby with the cleft palate when taking Zofran or ondansetron compared to mothers who did not take the drug at all.
In 2014, a research group in Canada analyzed an FDA database involving the side effects of Zofran and ondansetron. Researchers found cases where expecting mothers who were prescribed Zofran or ondansetron gave birth to children with musculoskeletal abnormalities, kidney problems, heart murmurs, low birth weight, and heart defects like ASD (atrial septal defect – hole in the heart). That same year, the Journal of Reproductive Toxicology published a study showing “the risks for cardiovascular defect and notably a cardiac septum defect were increased and statistically significant” in expecting mothers who were prescribed ondansetron while pregnant.
Is the Generic Drug Maker Liable?
Determining if the plaintiffs can sue the ondansetron pharmaceutical manufacturer over their damages will depend on the evidence in their case. Many lawsuits that have already been filed are built on specific factors that include:
- The drug maker was legally responsible for ensuring that their medication was safe before they offered it to the public.
- The pharmaceutical manufacturer failed to determine any safety risks from taking the drug before offering it for sale.
- The drug company promoted the medication as an effective and safe treatment for hyperemesis gravidarum (vomiting and nausea) and morning sickness even though they knew they were promoting it for off-label use.
- The medication company misrepresented many of the studies that had established that the drug was safe when the results revealed signs of toxicity and abnormal bone growth.
- The drug maker failed to ensure that the medication was properly evaluated and that all the safety information and data on ondansetron could be used by expecting mothers.
- The pharmaceutical company manufactured, marketed, and promoted a defective medication.
- The drug company fraudulently and falsely claimed that ondansetron was safe for off-label use for expecting mothers.
Despite the serious side effects, the sales of ondansetron rose significantly in 2013 where 110,000 monthly prescriptions were written for expecting mothers. In 2014, the American Journal of Obstetrics and Gynecology published an article showing the significant surge in ondansetron prescriptions even though there were already significant concerns over the safety of the fetus. Doctors are either not getting the word of the dangerous side effects, or there are no other medications to treat serious cases involving vomiting and nausea when pregnant.
Can I Pursue a Legal Claim?
Ever since the problems associated with the drug came to light, many parents continue to file civil lawsuits against the drug makers manufacturing ondansetron, the generic form of Zofran. The suits are based on the claim that the anti-nausea anti-vomiting medication causes their newborns to needlessly suffer congenital disabilities. Some plaintiffs claim that the mother and children were used as human guinea pigs to promote the unsafe drug. Other parents with problems just like yours are filing their lawsuits in federal and state courts.
Since they were first manufactured, generic versions of Zofran have raised factual and legal implications to any possible lawsuit plaintiffs might file. Families who were harmed by the drug defects might be able to seek relief if their loved one suffered injuries due to a generic version of Zofran. However, it is best to speak with a competent attorney who can analyze the specifics of your situation.
Hiring a Lawyer
Rosenfeld Injury Lawyers LLC is a plaintiff's law firm. Our team of attorneys focus our attention on protecting the rights of our clients who have suffered severe injury from dangerous pharmaceutical medications. We have successfully litigated cases against pharmaceutical giants to ensure the victims receive adequate financial compensation to recover their damages.
If the Zofran generic drug caused your loved ones harm, we encourage you to contact our law firm today at (888) 424-5757 for help. We have already obtained millions for our clients to pay for their medical costs, household bills, out-of-pocket expenses, pain, suffering, and emotional damage and we can help your family too.
Contact our attorneys today to schedule a free, no-obligation case consultation to discuss the merits of your monetary recovery claim. Our legal team accepts every personal injury case, wrongful death lawsuit, and bad drug product liability claims through contingency fee arrangements. This agreement postpones the payment of legal services until after we have successfully completed your case through a jury trial or negotiated out of court settlement.
Our law firm gets results quickly. We give 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?
- What damages are available for myself and my child in a Zofran birth defect lawsuit?
- Are there any class action lawsuits against GlaxoSmithKline, the manufacturer of Zofran, for children who have birth defects following Zofran usage during pregnancy?