James J. Martines, Esq., is an attorney who also contributes to a blog at the Las Vegas Sun. Last month, when contributing a column about the importance of class-action lawsuits, Martines revealed his and his family’s personal connection to Zofran.
“When the pediatric cardiologist told me and my wife five years ago that our newborn daughter suffered from atrial septal defect, the last question on my mind was whom to blame,” Martines writes in the Sun (5/17/15).
“But it wasn’t long before we learned the drug my wife was prescribed for morning sickness during her first trimester, Zofran, likely was the culprit.”
Martines goes on to detail the history of Zofran, approved in 1991 by the US Food and Drug Administration (FDA) to treat severe nausea experienced by cancer patients following chemotherapy or patients who become nauseated from post-operative medications. Zofran was never approved for use by pregnant women to combat morning sickness.
However, doctors began prescribing Zofran off-label to pregnant mothers having serious issues with morning sickness. As doctors have the legal, moral and ethical authority to prescribe drugs for indications to which they were not approved (off-label), it is easy to see how an approval parameter goes off the rails. The reason for the FDA’s hesitation to approve Zofran for morning sickness in pregnant women in the first place was likely due to a lack of definitive information assessing the risk for such an indication. Zofran’s manufacturer, GlaxoSmithKline (GSK), said as much to the Toronto Star a few years ago, when GSK noted that the potential effects of Zofran on pregnant mothers and their unborn children had not been studied.
That apparently didn’t stop GSK from allegedly promoting Zofran off-label to doctors, suggesting that Zofran could be a good option for combatting morning sickness.
It’s all well and good for doctors to undertake their ethical, moral and legal authority to prescribe a medication off-label if it is thought to benefit their patients. However, were doctors apprised of the necessary information in order to make an informed choice? And would it be even possible to test Zofran for birth defects in pregnant mothers, given the potential risks to an unborn child, even in a clinical trial?
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Such questions over the potential for Zofran birth defects are part of any Zofran lawsuit. Attorney Martines notes there have been “thousands of birth defects caused by Zofran, including heart defects, cleft lips and cleft palates.”
As an attorney, Martines knows the value of litigation in stemming the tide of injury and a lifetime of heartache and limitation to an innocent child. “It is up to us to stop more innocent children from being harmed and to help those who already have been harmed,” Martines writes.” As a father who has experienced the panic of Zofran birth defect firsthand, Martines carries a unique perspective.