Zofran and Potential Litigation
Morning sickness is a common affliction among pregnant women with roughly 8 in 10 women experiencing it to some degree. Some pregnant women suffer from an extreme form of nausea called hyperemesis gravidarum that can cause dehydration, severe weight loss and muscle wasting. To combat the painful and occasional debilitating effects of morning nausea, many women take anti-nausea medication. One of the medications that millions of women have taken is Zofran.
Zofran was developed by GlaxoSmithKline (GSK) and introduced in the early 1990s for many people suffering from nausea but it was not approved for use by pregnant women. Regardless, Zofran was a drug the company allegedly promoted to doctors and their pregnant patients as an effective treatment.
Alleged Link to Birth Defects
Any time medication is prescribed to pregnant women, the risk of the fetus developing a birth defect must be taken into account. Recent studies of the drug’s effect on the fetus that were undertaken after reports of babies born with certain birth defects after their mothers ingested the drug have confirmed that the drug crosses the placenta and remains with the fetus after birth for a time. The birth defects that some experts have linked to the drug include:
- Cleft palate
- Atrial septal defect
- Skeletal deformities
- Growth restriction
- Kidney problems
Researchers using data from the Danish Medical Birth Registry found that the risk of birth defect following use of Zofran was as much as 30%.
One of more serious complications in which Zofran is allegedly a substantial factor is atrial septal defect where a hole develops in the wall between the two chambers of the heart. If undetected, it can lead to early death or the individual can develop chronic lung infections, fatigue or shortness of breath. Surgery is necessary to repair the defect.
In 2012, the Department of Justice found criminal conduct by GSK for promoting off-label use of certain drugs, including Zofran, and providing payments or kickbacks to physicians who prescribed it. GSK was fined $3 billion.
Mounting Lawsuits as Harbinger?
A number of individual lawsuits have been filed against GSK alleging that it failed to conduct clinical trials of the medication as it applied to pregnant women, failed to disclose research data and falsely marketed it to physicians and patients. To date, the FDA has not banned its use by pregnant women but in 2013, it did issue a warning against its use in pregnant women, especially those with electrolyte imbalances.
GSK has not issued any warnings of its own and denies any link to birth defects from use of the drug. Though lawsuits are mounting, none of yet come to trial. Birth defect cases are difficult to prove in individual cases since other factors such as genetics or other drug or alcohol use by a pregnant woman are also high risk factors.
These cases are not appropriate for class action status because of the unique nature of the injuries and damages suffered by plaintiffs. Still, if more lawsuits are filed, as some legal observers expect, the cases may be consolidated for management in a MDL or multi-district litigation format so that common issues and disputes related to discovery may resolved and be applicable to all cases.
Each case, however, is tried separately. Often, it is only when a company begins to lose a series of multi-million dollar verdicts does it resort to the bargaining table to work out a mass settlement but without admission of liability.