A Kansas woman, Samantha Brosseau, filed a personal injury and product liability lawsuit against GlaxoSmithKline (GSK), the manufacturer of the blockbuster drug Zofran. Brosseau took the drug to treat pregnancy-associated morning sickness.
Allegations: Zofran Caused Hole in the Heart
According to Brosseau, Zofran caused her daughter to be born with an atrial septal defect or a hole in the heart. Atrial septal defect can be a serious life threatening heart condition, which can only be corrected by invasive cardiology procedures or in severe cases, open heart surgery.
Brosseau alleges that GSK failed to warn pregnant mothers about the congenital heart defect risks with Zofran. Brosseau claims that her daughter, K.C., was born with hole in the heart from intra-uterine exposure to Zofran during the first trimester of pregnancy.
What is Zofran?
Zofran is a drug developed by GSK, and approved by the FDA in 1991, only for the treatment of nausea and vomiting in cancer patients after chemotherapy, and radiation therapy. GSK through aggressive marketing aimed at pregnant women and their doctors, has made Zofran the single most popular drug for the treatment of morning sickness.
Pharmaceutical companies are not allowed to promote or market drugs to patients beyond their approved use by the FDA. This is known as “off-label” marketing.