Having a baby is supposed to be a joyous time for new parents. Unfortunately, when a baby has birth defects, that joy is often replaced with sadness, fear, and anger. In some situations, birth defects are hereditary, but birth defects related to prescription drugs and physician error are increasingly common. Although compensation alone cannot heal your child, it may help you obtain the necessary care and treatment your child needs to have a healthy, normal life.
When we are ill, we usually go to the doctor. This is just as true for pregnant women. If a doctor prescribes a medication to help us feel better, we put our trust in this advice. After all, why would a physician prescribe medications that hurt us? Unfortunately, just as we rely on doctors for sound medical advice, they rely on pharmaceutical companies to provide safe medications. When drug companies fail to properly test new drugs, or fail to warn about risks associated with those drugs, they should be held accountable.
GSK Only Tested Zofran in Pregnant Animals
The drug Zofran is used to treat nausea in patients undergoing chemotherapy. Pregnancy-related nausea has plagued expectant mothers since the beginning of time. With Zofran, pharmaceutical giant GlaxoSmithKline claimed to have a solution to this problem. In addition to treating chemotherapy-related nausea, Zofran can also decrease the effects of morning sickness.
Zofran is a Category B Drug
Unfortunately, new lawsuits claim that GlaxoSmithKline never got proper FDA approval for the drug’s use in pregnant patients. It was classified as a Category B pregnancy drug, meaning it was only ever tested on pregnant animals. For this reason, use in pregnant patients is considered “off-label” use. Although doctors are allowed to prescribe medications for off-label use, pharmaceutical companies are not allowed to market them for these purposes. It seems as though GSK did not follow these guidelines.
New lawsuits allege that GSK was “using expectant mothers and their unborn children as human guinea pigs” to test Zofran. Unfortunately, Zofran use in pregnant women has been linked to several life-threatening and life-altering conditions, including orofacial and septal defects, congenital heart problems, kidney malformation, and even death. Following an investigation by the Department of Justice, GSK has pled guilty and agreed to pay $3 billion in fines and compensation. Continue reading