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    Zofran Lawsuit Numbers Are Expected To Continue Growing

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    The number of lawsuits filed against GlaxoSmithKline is expected to continue growing even after the discovery and trial phases begin.

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    Hundreds of Zofran birth defect lawsuits have been filed against GlaxoSmithKline (GSK) and that number is expected to continue growing.

    Zofran, an anti-emetic medication, has been prescribed in both IV and pill form to hundreds of thousands, if not millions, of pregnant women since it first came on the market in 1991. In fact, the drug is still one of the most popular drugs prescribed to expectant mothers to treat their morning sickness, a condition that causes nausea and vomiting. Until recently, however, doctors and their patients were unaware that the drug had not been approved for this use.

    The FDA only approved Zofran for patients who experience nausea and vomiting after they were treated with chemotherapy and radiation or after being under anesthesia. Controlled safety testing was not performed on pregnant women.

    Despite this, GlaxoSmithKline pursued an advertising campaign which informed doctors and the public that the drug was a “safe” and “effective” treatment for morning sickness. The company knew that the anti-nausea medications available to OB/GYN’s are limited and that doctors are legally able to prescribe drugs “off-label”.

    The company has allegedly received numerous reports of birth defects since they first began this campaign, however, this did not deter them from continuing to promote the drug in this manner.

    In each of the lawsuits filed, parents allege that Zofran exposure in the womb caused a child to be born with a birth defect. Defects have included cleft lip, cleft palate, transposition of the greater vessels, atrial septal defect, ventricular septal defect, kidney defects, respiratory defects, and clubfoot.

    The majority of the lawsuits have been consolidated into MDL 2657. The cases will be tried in the District of Massachusetts by Judge F. Dennis Saylor. The hope is that by consolidating these complaints, all parties involved will be saved time and money. There has been no word as to when the trials will begin.

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    Michael Monheit



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