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A Massachusetts child was born with a severe cardiac defect after her mother was prescribed Zofran while she was pregnant. Continue reading
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Sep 18, 2015 /prREACH/ -- In a new lawsuit filed in the U.S. District Court of the District of Massachusetts under case number 1:15-cv-13002-FDS, by the family of a young girl, GlaxoSmithKline is accused of allegedly conducting business in such a way that it caused “devastating, irreversible, and life-long consequences and suffering to innocent newborns and their families.”
The family in this case celebrated the birth of their daughter in 2008. Upon her delivery, the doctor removed her from the delivery room without delay due to concerns about her color. The child underwent diagnostic testing and it was determined that she had a Transposition of the Greater Vessels (TGV) as well as pulmonary stenosis.
TGV is a rare condition where the two main blood vessels that carry blood to and from the heart are switched. As a result, the blood only circulates between the heart and lungs. This means that the rest of the body does not receive enough oxygen. During the first five days of her life, the child had a surgical procedure known as an Arterial Switch performed to correct her TGV. Later in life she also had a balloon atrial septostomy to improve her pulmonary stenosis. Despite doctors best efforts, this procedure failed and her pulmonary stenosis has not improved at all.
The lawsuit alleges that her birth defects “impair her ability to develop fully and enjoy life both at home and at school. Every day, the plaintiffs live in fear of what could happen to their daughter and the effects her condition has and will continue to have on her daily activities.” The complaint further notes that “Had plaintiffs known the truth about Zofran’s unreasonable risk of harm, long concealed by GSK, the plaintiff would never have taken Zofran and her child would never have been injured as described herein.”
Zofran, a drug manufactured by GSK, received approval from the FDA several decades ago to treat nausea and vomiting in chemotherapy and radiation patients, as well as post surgical patients experiencing nausea. The drug was never approved for pregnant women experiencing morning sickness.
Nonetheless, GSK pursued marketing which lead both the public and medical community to believe that Zofran was safe to be taken during pregnancy. As Zofran gained popularity among OB/GYN’s, GSK allegedly was contacted and informed of over 200 cases of birth defects in children who were born to women that were prescribed the drug. Following a warning letter that the FDA had sent GSK in 1999, regarding the “off-label” marketing of several of their drugs, the U.S. Department of Justice filed a lawsuit against GSK.
This lawsuit alleged that GSK unlawfully marketed numerous drugs, including Zofran, “off-label”. GSK agreed to a settlement in 2012, paying fines of three billion dollars.