The American public is generally lead to believe that birth defects are relatively rare and that the appropriate regulatory agencies are an adequate measure to prevent expectant mothers from ingesting any substances which may cause fetal harm. However, two recent developments are prompting critics to question whether the United States Food and Drug Administration (FDA), the agency we trust to properly research any potential links between prescription drugs and birth defects, is actually receiving necessary information from medical professionals in order to take appropriate action.
Three counties in Washington state experienced an unexplained surge in severe birth defects as reported by local hospitals over the past five years. Babies were being born with symptoms of anencephaly, a congenital absence of the cranial vault, with the cerebral hemispheres completely missing or reduced to small masses (infants are born with significant portions of the brain and skull). Newborns with this disorder do not survive longer than a few hours to a few days after birth. Yakima, Benton, and Franklin counties are currently exploring potential causes of the increase in birth defect rates, but a cause has yet to be identified.
In addition to the cases reported in Washington, litigation has begun in multiple cases for pregnant women who took the anti-nausea drug Zofran. Zofran was approved by the FDA in 1991 to treat nausea and vomiting in chemotherapy, radiation therapy, and surgical patients. Despite the fact that it was not indicated for use in pregnant women, the manufacturer (GlaksoSmithKline) marketed the drug to women suffering from morning sickness. Several studies, taking place in countries across the world, found links between Zofran and birth defects, particularly congenital heart defects and cleft pallet defects.
Many critics are saying that state and federal regulatory agencies have not been appropriately proactive in addressing the issues surrounding birth defects. A Seattle Times expose noted that 41 mothers in the counties affected by the spike in anencephaly have yet to be contacted by Washington State health officials. Allison Ashley-Koch, a researcher with Duke University claimed that she noticed the abnormally high anencephaly rates two years ago and contacted the CDC, but officials were uninterested in opening an official investigation.
As patients, we have to have a certain level of trust in not only the doctors from whom we seek medical care, but also the regulatory bodies charged with making sure that the medicine we take is safe and does not cause additional harm. It is a troubling, yet very real fact that medical devices and prescription medication can make it through approval processes, only to cause harm to many patients. When such medications reach a fetus in utero, the results can be devastating or even fatal.
If a mother or newborn experiences any type of illness or injury during pregnancy or the birthing process, it can be difficult to know what the actual cause was. If you or someone you love has been injured during this critical time, please contact our team. We will work with our staff physician to examine the specifics of your case and help you fight for any compensation you may deserve.