Initially reaching the American market in 1991, anti-nausea medication Zofran (ondansetron) is a GlaxoSmithKline product with FDA approval for the treatment of vomiting and nausea in patients who have undergone surgery or chemotherapy. While never receiving agency approval for use in pregnant women as a morning sickness remedy, this “off-label” use of Zofran has gained popularity in recent years. Expectant mothers suffering from hyperemesis gravidarum, a severe form morning sickness, often feel they need pharmacological assistance in battling the crippling and potentially dangerous effects of the affliction, with many turning to anti-nausea meds.
Though Zofran was never approved by the FDA as a treatment for morning sickness, GlaxoSmithKline marketed the drug for this very use. The pharmaceutical giant’s activities with regard to promoting numerous off-label uses for several prescription drugs, including Zofran, contributed to its recent $3 billion settlement agreement with the Department of Justice to resolve the allegations. Though GSK agreed to the settlement, the company has made no admission of liability.
Recent years have also witnessed the emergence of allegations and research studies suggesting a link between Zofran use during pregnancy and birth defects including atrial septal defects in newborns. As a result of these factors and accusations, some women are now considering filing a Zofran lawsuit as a means to secure fair compensation to help cope with their child’s life-altering injuries.
Research on Zofran for morning sickness
New research has been revealed which has promoted growing concern about the use of Zofran by pregnant women suffering from severe morning sickness and its potential to cause birth defects. A study published by the New England Journal of Medicine in 2013 evaluated data culled from the Danish Medical Birth Registry between 2004-2011 and did not find a conclusive connection between the drug and birth defects. However, those critical of the study emphasized that the average gestational age of those studied was over 10 weeks, the point of pregnancy at which the most risk for birth defects has passed.
A different study was subsequently undertaken by a new group of researchers, using the same Danish birth registry. However, a broadened time period was used, extending the review to include 900,000 births during 1997-2010. In the end, the authors of the study found that Zofran use correlated to twice the risk of heart defects in the subject infants and a 30% increase in the number of total birth defects. This conclusion was attributed to the fact that 4.7% of mothers who had used Zofran while pregnant had babies with birth defects, while just 3.5% of those who did not take the drug had such an outcome.
The following defects are allegedly connected to Zofran use during pregnancy:
- Atrial septal defects
- Cleft palate
- Cleft lip
- Kidney issues
- Heart murmur
- Fetal growth restriction
- Skull deformities
Such congenital defects are extremely serious and pose substantial risk to the well-being of the infants affected. They also often require multiple surgical interventions, therapy and costly treatment that many parents simply cannot afford. Though the FDA has yet to issue any formal warnings about Zofran use in pregnancy, it has issued an alert about its safety for adults with existing heart conditions. This has been taken by some as support for the growing allegations of the drug’s dangers.
Why Zofran lawsuits are likely to increase
Morning sickness in pregnancy is an extremely common phenomenon, affecting roughly 8 of 10 expectant mothers. The more severe form of the condition can pose real dangers to both mother and child, including muscle wasting, dehydration, nutritional deficiency and dramatic weight loss. That is why Zofran has been a welcome solution for many, and its use for this purpose has grown to become extremely widespread. Given the volume of women who have taken Zofran as a way to ameliorate pregnancy sickness, it should come as no surprise that recent concerns about the drug’s safety are triggering legal action among some mothers.
Zofran lawyers across the country are reviewing potential cases and researching GlaxoSmithKline’s involvement in the marketing of this specific off-label application. Current plaintiffs allege that the drug was promoted to physicians and patients as a safe, effective method of treating their condition, with full knowledge of possible dangers. Product liability lawsuits are designed not only to help the injured secure financial compensation, but also to help hold reckless drug makers accountable for jeopardizing the public interest and provide a deterrent effect.
Compensation sought by plaintiffs
Though perhaps a daunting prospect to many mothers, filing a Zofran lawsuit likely represents the best chance to receive optimal compensation for their child’s injury.
The legal system affords victims the ability to seek financial resources, which could include payment for:
- Past, present and future medical bills
- Required therapy and rehabilitation
- Lost wages
- Lost earning capacity
- Pain and suffering
- Emotional distress
Who is a strong candidate for filing a Zofran lawsuit?
GlaxoSmithKline may face a number of lawsuits regarding Zofran-related side effects in the coming months and years, but that is not to say that every expectant mother who used to anti-nausea drug has a viable case against the company. Therefore, it is important to clarify which prospective plaintiffs stand the best chance of success in such a lawsuit, and which might be disqualified from recovery attempts.
The best candidates for filing a Zofran lawsuit are those who:
- Can demonstrate actual harm to their infant. Zofran is a drug given to countless pregnant women annually, many of whom have healthy outcomes. The mere possibility that Zofran could cause harm is insufficient basis on its own for a lawsuit, but if actual harm occurred, a plaintiff may consider proceeding.
- Cannot point to any other potential causes of the resulting birth defects. There must be a direct connection made between the use of Zofran and the birth defect suffered. Any potential intervening causes such as genetic factors or unsafe behavior during pregnancy may undermine a lawsuit significantly.
- Were unaware and uninformed about the possible risks of taking Zofran while pregnant. If defense counsel can demonstrate maternal awareness of the dangers, recovery chances will likely diminish.
Because only a few Zofran lawsuits have been brought thus far, the eventual scope of litigation relating to the drug has yet to be fully determined. However, considering the prevalence of morning sickness among pregnant women and the frequency with which Zofran is prescribed in an off-label manner to treat it, more women may come forward in the coming months.
Attorneys specializing in dangerous drugs and personal injury are continuing to evaluate potential claims and help families decide if litigation is warranted.
- Toronto Star, Birth defects blamed on unapproved morning sickness treatment, www.thestar.com/news/gta/2014/06/25/birth_defects_blamed_on_unapproved_morning_sickness_treatment.html
- United States Department of Justice, GlaxoSmithKline to Plead Guilty and Pay$3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data, www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report
- U.S. Food and Drug Administration, Ondansetron (marketed as Zofran) Information, www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationfor PatientsandProviders/ucm271924.htm
- Motherisk, Ondansetron Use In Early Pregnancy And The Risk Of Congenital Malformations - A Register Based Nationwide Cohort Study, www.motherisk..org/documents/studies/Ondansetron-Use-In-Early-Pregnancy.pdf
- Centers for Disease Control and Prevention, Facts about Cleft Lip and Palate, http://www.cdc.gov/ncbddd/birthdefects/CleftLip.html