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A new lawsuit filed in the state of Alabama alleges that an infant boy suffers from a rare heart defect known as Hypoplastic Left Heart Syndrome because his mother took Zofran during her pregnancy to treat morning sickness. Continue reading
prREACH
Sep 04, 2015 /prREACH/ -- A mother in Alabama has filed a new Zofran lawsuit in the United States District Court Northern District of Alabama Southern Division under case number 2:15-cv-01233-JEO on July 23rd, 2015.
The lawsuit alleges that the plaintiff’s child, a son born in 2014, suffers from several birth defects due to the mother’s use of Zofran during her pregnancy. The mother was prescribed Zofran during her first trimester to treat her morning sickness. Her son was diagnosed while he was still in the womb with Hypoplastic Left Heart Syndrome which is described by the Mayo Clinic as a “rare heart defect present at birth. In hypoplastic left heart syndrome, the left side of the heart is critically underdeveloped.” The defect is so severe that the left side of the heart can't pump blood to the rest of the body and so the right side of the heart must compensate and ends up being overworked.
The child in question required open heart surgery when he was just three days old followed by an open heart transplant when he was six months old. His condition requires ongoing medical care. The lawsuit has also noted the child suffers from a kidney defect but does not state what that defect is. His mother and the lawsuit allege that had she not taken Zofran during her first trimester, her son would not have developed the cardiac and kidney defects.
Zofran is an anti-emetic which was first approved for use by the FDA in 1991 for use in patients suffering from nausea after being under anesthesia and cancer patients being treated with chemotherapy and radiation. The FDA never approved of Zofran being used in pregnant women to treat morning sickness nor has GlaxoSmithKline, the company behind Zofran, performed any studies or clinical trials proving the use of Zofran is safe during pregnancy. Nonetheless, GSK chose to advertise their product “off-label” to the medical community and the public as safe for use during pregnancy.
In 2012, GSK agreed to a settle on a lawsuit from the U.S. Department of Justice which alleged that GSK unlawfully promoted the use of several drugs “off-label”, including Zofran. The settlement included a fine of 3 billion dollars to be paid by GSK.
Since GSK first began marketing Zofran “off-label” for morning sickness, the company has allegedly received over 200 reports of birth defects in children who were born to mothers that were prescribed Zofran. In recent years, numerous epidemiological studies have suggested that there is an increased risk in the likelihood of birth defects among women exposed to the drug during pregnancy. The birth defects that have been listed in lawsuits filed against GSK include cleft palate, cleft lip, atrial septal defects, ventricular septal defects, and renal defects.