A type of 5-HT3 antagonist that quells nausea and vomiting, Zofran (ondansetron) was approved in 1991 to help cancer patients undergoing chemotherapy and radiation. Zofran also relieves anesthesia-induced nausea, but the drug was never approved as a morning sickness remedy for pregnant women. Nonetheless, doctors across the nation have prescribed Zofran to patients suffering from extreme morning sickness. Hyperemesis gravidarum is characterized by persistent vomiting, dehydration, severe nausea and electrolyte imbalances that pose health risk for both mother and child.
Zofran pregnancy risks not fully disclosed
Plaintiffs who are suing Zofran manufacturer GlaxoSmithKline (GSK) contend that the anti-nausea drug is responsible for their baby’s cleft palate, heart malformations and other birth defects. These women were prescribed ondansetron by their physicians as an off-label morning sickness treatment, and argue that they were not adequately warned about Zofran pregnancy risks. Some in the medical community say that additional research is needed to determine whether Zofran is truly safe to the developing fetus, or if the drug poses unnecessary risk of congenital defects that may lead to life-long disability.
In these complex situations where personal injury is blamed on a failure to warn or product defect, it’s crucial to partner with a law firm which has a demonstrable track record of verdicts and settlements in similar cases.
Taking on a billion dollar pharmaceutical company is no easy task and requires diligence, financial resources and exceptional mediation and trial skills. Edelman, Krasin & Jaye are national product liability lawyers who leverage more than six decades of experience advocating for victims and securing maximum damage awards. If you have questions about pursuing a Zofran lawsuit, we invite you to contact our office for a free and confidential consultation.
Allegations involving Zofran and birth defects
There are few published studies on the connection between Zofran use during pregnancy and congenital defects in humans, and the findings of those in existence have yielded different results. A study published in the New England Journal of Medicine in 2013 found that taking Zofran during pregnancy was not associated with an increased risk of birth defects or fetal injury.
However, researchers who evaluated 900,000 live births from the Danish Registry discovered that mothers who took Zofran while expecting were two times more likely to have a child with heart defects.
In light of recent accusations regarding Zofran risks to the unborn child, women in the throes of unbearable morning sickness are left to grapple with a tough decision– is Zofran a safe anti-nausea treatment, or do the risks outweigh the benefits?
GlaxoSmithKline is named defendant in several Zofran lawsuits that contend the company has conducted previous animal trials which resulted in intrauterine deaths and fetal malformations. Claimants argue this is evidence of the drug’s ability to cross the placental barrier and affect fetal health and growth.
More research is necessary to understand if Zofran increases risk for:
- Skull deformities
- Fetal growth restriction
- Cleft palate or cleft lip
- Heart murmur
- Atrial septal defect
- Facial dysmorphia
- Kidney malformations
- Fetal death
At Edelman, Krasin & Jaye, we believe that consumers should be made fully aware of all side effects and risks of a prescription medication, and that drug companies should be held accountable for negligence and fraudulent misrepresentation of a product. Our personal injury attorneys meticulously investigate all liable parties in dangerous drug claims, and promise to seek just compensation for families who have already suffered enough.
Claims made in Zofran litigation
In 2012, GlaxoSmithKline reached a $3 billion settlement with the U.S. Department of Justice to resolve allegations of civil liability regarding the unlawful (off-label) promotion of several drugs, such as Zofran, Wellbutrin and Paxil. The settlement also resolved claims of fraud and GSK’s purported failure to report important drug safety data to health regulators. In spite of the colossal payout, GSK staunchly denies any liability or wrongdoing and continues to stand behind the safety of Zofran.
For now, this stance has been unaffected by the recent wave of product liability lawsuits alleging Zofran-related birth defects, which claim financial losses and life-altering injury from the off-label promotion of the medication.
An Arkansas couple who is suing GSK argues that had they known about the heightened risk of birth defects associated with Zofran, the mother would have sought alternative treatments for her morning sickness. Their child was born with a partial cleft lip and has suffered developmental delays in addition to problems with speech that require physical, speech and occupational therapy.
Legal action may help plaintiffs recover damages for:
- Past, present and future medical costs
- Loss of income
- Pain and suffering
- Therapy & rehabilitation expenses
- Emotional distress
- Diminished earning capacity
- Additional punitive damages
Zofran attorneys on your side
If you or someone you love took Zofran during pregnancy and had a child with birth defects, call Edelman, Krasin & Jaye to learn more about your legal options. Our veteran team is here to answer your questions and begin civil proceedings should you have a viable claim for damages.
Fighting Big Pharma is best left to the professionals, and you can rest assured we have the expertise, legal savvy and determination to achieve a favorable outcome for you and your family. There are never any up-front costs since we work on a contingency fee basis. Call 1-800-469-7429 to talk with a Zofran lawyer, free of charge.
- United States Department of Justice, GlaxoSmithKline to Plead Guilty and Pay$3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data http://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report
- NIH, Medications Used to Treat Nausea and Vomiting of Pregnancy and the Risk of Selected Birth Defects http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3299087/
- Toronto Star, Birth Defects Blamed On Unapproved Morning Sickness Treatment http://www.thestar.com/news/gta/2014/06/25/birth_defects_blamed_on_unapproved_morning_sickness_treatment.html