In a new lawsuit filed against GlaxoSmithKline, the parents of a child born in Alabama claim that their daughters cardiac defects were caused by the drug Zofran.
The complaint, filed in the United States District Court Northern District of Alabama Southern Division under case number 2:15-cv-01552-TMP, alleges that “GSK knew that Zofran was unsafe for ingestion by expectant mothers.”
The mother, in this case, was prescribed Zofran during her first trimester. Both she and her doctor believed the drug to be a safe treatment for her morning sickness. However, when her child was born in 2013, doctors informed the family that the baby had severe cardiac defects. An open heart surgery was performed when she was eight-months-old to fix the defect. Unfortunately, her doctors predict that this surgery was not enough, and in the future, additional surgical procedures will need to be performed.
Zofran is an anti-emetic drug. The U.S. Food and Drug Administration approved it as a treatment for nausea and vomiting after chemotherapy and radiation treatments, and also following anesthesia. The drug was never approved as a treatment for morning sickness. Despite this, GSK marketed the drug as a safe and effective treatment for expectant mothers.
In 1999, the FDA sent GSK a warning letter, stating that they were aware that GSK had begun to market Zofran to the medical community and public as a treatment for morning sickness. The letter noted that the marketing campaign “promotes Zofran in a manner that is false or misleading because it lacks fair balance.” GSK ultimately ignored this warning to their detriment.
A few years later, the U.S. Department of Justice filed a lawsuit against GSK, alleging that the company had unlawfully promoted several of their drugs “off-label”, including Zofran. The lawsuit was settled in 2012, when GSK agreed to pay three billion dollars in fines.
At this time, over 60 lawsuits have been filed against the drug company, each alleging that Zofran caused a birth defect in an unborn child. Birth defects noted in the litigation include atrial septal defect, ventricular septal defect, transposition of the greater vessels, clubfoot, cleft lip, and cleft palate.
Name: Michael Monheit
Source URL: http://www.prreach.com/pr/20717
Release ID: 94182