Certain prescription and over-the-counter (OTC) medications, when taken by a woman during pregnancy, can interfere with the development of the embryo or fetus she is carrying and result in severe birth defects in her child. Such substances are known as teratogens and may lead to the liability of drug companies that market these drugs for use by pregnant patients.
While severe morning sickness, or hyperemesis gravidarmum, can be harmful to a pregnant woman or her fetus, the prescription anti-nausea drug Zofran (Ondansetran), which has been marketed “off-label” (i.e. for a use unapproved by the FDA) by the drug manufacturer, GlaxoSmithKline (GSK), to control symptoms of severe morning sickness during pregnancy, has been found in multiple studies to cause preterm labor, stillbirths, and severe birth defects, including neural tube defects and heart and cleft abnormalities. The use of Zofran during the first trimester of pregnancy, when most pregnant women experience morning sickness, poses the greatest risk of congenital teratogenic birth defects. According to the Centers for Disease Control and Prevention (CDC), a woman’s use of Zofran during her pregnancy can increase the risks of certain types of congenital birth defects by 100%.
Zofran, a 5-HT3 receptor antagonist that blocks the action of natural chemicals in the human body that can cause nausea and/or vomiting, has been approved by the U.S. Food and Drug Administration (FDA) to prevent nausea and vomiting caused not by pregnancy but by chemotherapy, radiation therapy, and surgery. These are the only uses of Zofran that have been approved by the FDA. Despite the lack of FDA approval, however, GSK marketed the off-label use of Zofran to alleviate morning sickness, resulting in a multi-billion dollar settlement by GSK with the U.S. Department of Justice for this illegal marketing.
The off-label marketing of Zofran by GSK has led to the use of Zofran by thousands of pregnant women whose children may have sustained severe birth defects or death as a result. If your child was stillborn or was born with a congenital heart or cleft birth defect and you were prescribed Zofran or another anti-nausea drug to control morning sickness during your pregnancy, you may be entitled to compensation for your child’s injuries from the drug manufacturer. Attorney Jeffrey Killino and his nationally respected team of birth-injury lawyers have extensive experience with birth-injury and birth-defect cases, including those arising from birth defects caused by drugs illegally marketed by drug companies for use by pregnant women. Contact attorney Killino for more information about your legal rights and options.
Drug Company Liability for Birth Defects Caused by Drugs Marketed for Unapproved Uses
The marketing of Zofran to physicians to alleviate their pregnant patients’ morning sickness, nausea, and vomiting constitutes the illegal marketing of a product for a use not approved by the FDA and puts the safety of the unborn children of women prescribed Zofran for this non-approved use in danger. As a result of studies indicating the existence of an increased risk of birth defects due to use of Zofran during the first and second trimesters of pregnancy, the FDA has issued a specific warning against the use of this drug during that time and cautioning doctors not to prescribe it to pregnant women unless and until its effects on developing fetuses are better understood.
Drug companies have a duty to warn physicians to whom they market their products of drug side effects known to the drug companies, or that reasonably should have been known to these companies, and to provide physicians with other instructions and warnings necessary for the reasonably safe use of companies’ drugs by physicians’ patients. The failure to provide such warnings and instructions may be found to render a pharmaceutical product defective under products-liability law and result in a drug manufacturer’s liability for patients’ injuries or deaths determined to have been caused by the warnings defect. Thus, the marketing of a product such as Zofran for off-label use during a woman’s pregnancy may be found to have rendered the product “defective” under products-liability law and may lead to the drug manufacturer’s strict liability for children’s injuries or deaths determined to have been caused by the drug’s off-label use.
Obtain Legal Assistance from Birth Injury Attorney Jeffrey Killino
Birth-injury and birth-defect attorney Jeffrey Killino has dedicated his practice to obtaining justice for all children who suffer from birth injuries and defects caused by medical malpractice or dangerous and defective drugs or other products. If your child sustained a birth injury or defect as a result of medical negligence or a defective drug or other product, our nationally recognized team of birth-injury and birth-defect lawyers can help you fight for the compensation you and your child deserve.