Is CDC birth defect monitoring effective?
By Laurence Banville
The Plaintiff's AllegationsIn each of the lawsuits filed against GSK, plaintiffs have alleged that the company unlawfully advertised their anti-nausea medication Zofran for “off-label” use and that as a result, an unborn child developed a birth defect. Mothers have claimed that their child’s cleft lip, cleft palate, transposition of the greater vessels, atrial septal defect, ventricular septal defect, clubfoot, or respiratory distress syndrome were caused by the drug.
Zofran earned U.S. Food and Drug Administration approval over twenty years ago. The FDA approval covered the use of the drug in patients who are experiencing nausea and vomiting after chemotherapy, radiation, and anesthesia. The drug was not approved as a treatment for morning sickness, nor was it tested on expectant mothers to determine if it was safe.
Each plaintiff alleges that the company was negligent because they failed to warn both the medical community and the public of the risks.
Birth Defect Tracking: The CDCPlaintiffs are now questioning why the Centers for Disease Control and Prevention didn’t make a connection between the mother’s use of the drug and birth defects sooner. According to the CDC, there are programs in 41 states which monitor the number and type of birth defects. The purpose of these programs is to:
- understand if the number of birth defects is increasing or decreasing over time
- investigate possible causes of and risk factors for birth defects
- to educate the public about birth defects and prevent them
- to refer babies and families affected by birth defects to appropriate services
Numerous studies have been performed which report that when pregnant women took Zofran, there was a significant increase in the number of children born with a birth defect. So is it possible that the CDC missed something and that the department could have warned the public sooner?