“Andersen Study” Cited In Newest Zofran Lawsuit

  • Date: Nov 13, 2015
  • Category: Legal

The latest Zofran lawsuit has indicated that several epidemiological studies, including the “Andersen Study”, have concluded there is an increased risk for birth defects when a mother takes Zofran during her pregnancy.

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Nov 13, 2015 /prREACH/ -- The latest Zofran lawsuit, filed in the U.S. District Court of the Eastern District of Louisiana under case number 2:15-cv-04399-SM-DEK, has included data from an epidemiological study called the “Andersen Study”.

The Andersen Study used data collected from the Danish Medical Birth Registry and the National Hospital Register. Researchers examined the relationship between the use of Zofran during the first trimester of pregnancy and subgroups of congenital malformations. The study concluded that expectant mothers who took Zofran during their pregnancy were more likely to give birth to a child who suffered from a congenital heart defect.

This study is just one of several that link Zofran to birth defects in unborn children. Zofran, an anti-emetic, has been on the market since the U.S. Food and Drug Administration first approved it in 1991. The approval, however, only gave GSK permission to market the drug to patients who were suffering from nausea and vomiting after chemotherapy, radiation, or anesthesia. In spite of this, the company also marketed the drug “off-label” to both the medical community and the public as a treatment for morning sickness in expectant mothers.

The drug was prescribed to women around the country, and it wasn’t long before OB/GYNs began noticing that their patients had given birth to children with birth defects after the mother took Zofran. To date, GSK has allegedly received over 200 reports regarding the birth defects noted.

The first Zofran lawsuit was filed nearly two years ago, and since that time over 60 other complaints have been filed. In each case, the parents of a child allege the child’s birth defect was caused by prenatal exposure to the drug. Birth defects include clubfoot, cleft lip, cleft palate, respiratory distress syndrome, atrial septal defect, ventricular septal defect, transposition of the greater vessels, and kidney defects.

All Zofran lawsuits have now been combined into MDL 2657 and will be overseen by Judge F. Dennis Saylor in a district court in Boston. The consolidation was favored by both plaintiffs and the defendant, as it will prevent duplicate discovery, save both parties money, and expedite the litigation process.

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Michael Monheit



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