Mississippi Family Files Zofran Lawsuit
March 02, 2016 – – Zofranlegal.com has reported that one of the more than 220 lawsuits filed against GlaxoSmithKline regarding the drug Zofran, was filed by a family in Mississippi.
Their complaint, which was filed in the United States District Court for the Southern District of Mississippi under case number 5:15cv70DCB-MTP, alleges that exposure to the drug Zofran while still in the womb caused a young boy to develop a birth defect known as a soft cleft palate.
The mother was prescribed Zofran during her first trimester to treat nausea and vomiting relating to morning sickness. But, as her lawsuit states, the FDA never approved Zofran for the treatment of this condition. In fact, when the drug was approved by the FDA in 1991, they indicated that it should be used in patients undergoing anesthesia, chemotherapy, or radiation – not expectant mothers.
Doctors, however, are not legally bound to use a drug according to the label the FDA produces. GSK, knowing this fact, began to market the drug as a “safe” and “effective” treatment to OB/Gyns throughout the country. Their campaign was so successful that Zofran was prescribed to over a million women during the first year. This complaint, as well as one filed by the U.S. Department of Justice, alleges that this marketing tactic was unlawful, and that in order for GSK to have lawfully marketed the drugs, they would have had to “adequately the drug (including performing appropriate clinical studies) and formally submit to the FDA evidence demonstrating that the drug is safe…” for pregnant women and their unborn children.
A large number of birth defects have been blamed on exposure to Zofran, including cleft palate, cleft lip, atrial and ventricular septal defects, transposition of the greater vessels, respiratory distress syndrome, ear deformities, kidney defects, and clubfoot. So many cases have been filed that Judicial Panel on Multidistrict LItigation consolidated federally filed complaints into MDL 2657 so that plaintiffs involved would be saved time and money.
The litigation continues to grow and new lawsuits are being filed regularly. If you or a loved one have questions, please contact Michael Monheit, Esq., lead attorney at Monheit Law by calling (877) 620-8411.
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Michael Monheit
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