A California lawsuit has alleged that GlaxoSmithKline was aware that Zofran had the potential to harm unborn children prior to marketing their product as safe and effective.
Dec 25, 2015 /prREACH/ -- A lawsuit, filed in the United States District Court for the Central District of California under case number 8:15-cv-01552, has alleged that GlaxoSmithKline (GSK) was fully aware that their drug Zofran was unsafe for expectant mothers and their unborn children.
The complaint states that “In the 1980’s, GSK conducted animal studies which revealed evidence of toxicity, intrauterine deaths and malformations in offspring, and further showed that Zofran’s active ingredient transferred through the placental barrier of pregnant mammals to fetuses.” The plaintiffs have claimed that the company did not disclose any of this information to the medical community or the public.
GSK may have performed animal studies involving pregnant subjects, however, they never performed human clinical trials. This is why, when the U.S. Food and Drug Administration approved the drug in 1991, it did not include expectant mothers on the list of patients the drug was appropriate for. If fact, the drug was only approved for patients who are nauseous and vomiting after anesthesia, chemotherapy, and radiation.
However, GSK advertised the drug as a safe and effective treatment for morning sickness, a condition commonly diagnosed in pregnant women during the first trimester. Had doctors known that Zofran easily transferred through the placental barrier, they may have been less likely to prescribe the drug to their patients. Unborn children are particularly delicate during the first trimester because this is the period of time in which the majority of their development occurs. If a drug is introduced to their system, it may affect the development of the bones, muscles, kidneys, reproductive system, heart, and lungs.
This is what the complaint in California, as well as numerous other lawsuits are claiming - that when Zofran was administered to a pregnant woman during the first trimester, the drug affected the development of her unborn baby and a birth defect occurred. A wide variety of birth defects has been noted in the ongoing litigation, including atrial septal defect, ventricular septal defect, transposition of the greater vessels, kidney defects, cleft lip, cleft palate, kidney defects, and clubfoot.
At this time, several hundred lawsuits are awaiting trial. The plaintiffs in each case are seeking compensation for medical expenses and for the pain and suffering the child has had to endure due to their birth defect.