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Plaintiffs involved in the ongoing Zofran birth defect lawsuits are wondering why doctors around the country are able to prescribe drugs “off-label”. Continue reading
prREACH
Feb 19, 2016 /prREACH/ -- More than 220 families have pursued legal action against the drug manufacturer GlaxoSmithKline (GSK), alleging that the drug Zofran has caused birth defects in children who were exposed to the drug while still in the womb.
Parents who are involved in the ever growing litigation have questioned how doctors were able to prescribe the drug to expectant mothers as a treatment for morning sickness, when the U.S. Food and Drug Administration didn’t approve the drug for this use. In fact, the drug was only approved for the treatment of nausea and vomiting in patients being treated with radiation and chemotherapy or patients who were under anesthesia.
In the United States, doctors are legally allowed to prescribe drugs for the treatment of conditions that are not on the drug label. Off-label prescriptions are so common that it is believed that 1 in 5 written do not comply with FDA labelling. This practice can be extremely dangerous during pregnancy, when any drugs taken by the mother may be transferred to the unborn baby through the placental barrier. If this occurs, the drug may disrupt the developmental process and cause birth defects.
Plaintiffs are also alleging that GSK unlawfully advertised the drug for off-label use, encouraging doctors to prescribe Zofran to their patients. These claims echo those of the U.S. Department of Justice, which filed its own lawsuit against GSK making similar allegations. That lawsuit was settled in 2012, and, although the company does not admit to any wrongdoing, they did agree to pay fines of several billion dollars.
It is this advertising which plaintiffs claim lead to Zofran becoming one of the most popular drugs prescribed for the treatment of morning sickness, and as a result, the birth defects of the children named in each complaint. These birth defects have included cleft lip and palate, cardiac defects, and kidney defects.
Trial dates have yet to be set as the hundreds of complaints filed in MDL 2657 have not yet begun the discovery phase. The entire process will be overseen by Judge F. Dennis Saylor, who recently denied a motion filed by GSK, requesting that all lawsuits be dismissed completely.