A mother residing in Arkansas is one of the latest to file a lawsuit against GlaxoSmithKline, alleging that the company’s drug Zofran caused birth defects in her son.
Nov 06, 2015 /prREACH/ -- Another mother has filed a lawsuit against drug manufacturer GlaxoSmithKline, alleging that their drug, Zofran, caused more than one birth defect in her son. Although she and her child reside in Arkansas, the complaint was filed in the United States District Court of the Eastern District of Louisiana under case number 2:15-cv-04399-SM-DEK.
The child, in this case, was born in 2007. After his birth, he was diagnosed with clubfeet, a cleft palate, and respiratory distress syndrome. His mother believes that because she took Zofran during her pregnancy to treat her morning sickness, her son was born with these defects. He has had to undergo two operations during his lifetime. She claims that had she “...known the truth about Zofran’s unreasonable risk of harm, long concealed by GSK, she never would have taken Zofran, and her child would never have been injured…”
This complaint is just one of many, with over 60 filed against GSK. In each case, parents allege that Zofran caused birth defects such as cleft lip, cleft palate, atrial septal defect, ventricular septal defect, transposition of the greater vessels, kidney defects, and clubfoot. In many instances, it is noted that the family has other children that were born without defects and in those pregnancies the mother did not take Zofran.
Zofran is an anti-emetic which was marketed by GSK as a safe and effective treatment for morning sickness. What the public and medical community was not aware of, was that the U.S. Food and Drug Administration did not grant approval for the drug to be used for the treatment of this condition. The approval GSK received only allowed the drug to be used for the treatment of nausea and vomiting in patients who were being treated with chemotherapy and radiation, or pateints who were ill after being under anesthesia.
GSK faced allegations regarding their “off-label” promotions in a lawsuit filed by the U.S. Department of Justice. In 2012, the company agreed to settle the lawsuit and was required to pay fines of three billion dollars.
Recently, Zofran lawsuits were consolidated into MDL 2657. Both the plaintiffs and the defendants requested the consolidation from the Judicial Panel on Multidistrict Litigation because it would prevent duplicate discovery, save money for both parties, and expedite the litigation process.There has been no announcement as to when trials are set to begin.