InfoOctober 9, 2015 · Legal
New Zofran Lawsuit Alleges Drug Caused Child’s Cleft Lip
The parents of a Missouri child have alleged that the drug Zofran caused their child’s birth defect.Press Release VideoLoading the player...Details(prREACH)
The parents of a Missouri child have filed one of the newest lawsuits against drug developer GlaxoSmithKline.
The complaint, which was filed in the Philadelphia County Court of Common Pleas under case number 2:15-cv-04912-LFR, alleges that a young boy has suffered due to his exposure to the drug Zofran while he was still in the womb. The child was born in 2006, and at the time of his birth he was diagnosed with a cleft lip. The opening was noted to be on the upper lip from one side of his mouth extending into the nostril.
As an infant, he underwent corrective surgery which successfully closed the opening but left him with visible scarring. A second procedure was performed when he was six-years-old, but the scarring remained. The lawsuit alleges that he has been teased by other children due to his malformation and has suffered from emotional trauma as a result.
This lawsuit is just one of many, all of which allege that Zofran caused a birth defect in an unborn child. The birth defects noted include cleft lip, cleft palate, atrial septal defect, ventricular septal defect, transposition of the greater vessels, and clubfoot.
Zofran is an anti-nausea medication. GlaxoSmithKline received approval for Zofran from the U.S. Food and Drug Administration in 1991. The FDA specifically indicated that the drug was approved for chemotherapy and radiation patients, or patients who had recently been under anesthesia, and were experiencing nausea and vomiting. The approval did not include the use of the drug to treat morning sickness in pregnant women.
GSK ultimately decided to proceed with a marketing campaign which informed the medical community and the public that Zofran was safe to use during pregnancy. Doctors embraced the drug and prescribed it to countless women. Since the beginning of the marketing campaign GSK has allegedly received over 200 reports of birth defects associated with the use of Zofran.
On October 1st, 2015, the Judicial Panel on MultiDistrict Litigation met to hear arguments regarding the consolidation of the more than 50 lawsuits against GSK. The panel won’t announce its ruling for several weeks, but both the plaintiffs and GSK generally agree that an MDL is the proper course of action.LinksContact
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