What Are The Zofran MDL Questions Of Fact?
By Laurence Banville
Questions Of FactQuestions of fact are the questions that are asked regarding what happened during a series of events that ultimately lead to a lawsuit. Each of the Zofran birth defect lawsuits contains the following questions of fact:
- Did Zofran cause a birth defect in an unborn child?
- Did GlaxoSmithKline unlawfully promote Zofran “off-label” as a treatment for morning sickness?
- Did GlaxoSmithKline hide evidence that Zofran causes birth defects?
- Did GlaxoSmithKline fail to warn the public of the alleged side effects?
All of these questions will be addressed at trial. At this time, there have been no announcements regarding the dates for trials for MDL 2657.
GlaxoSmithKline And ZofranGlaxoSmithKline developed Zofran during the 1980’s and prior to submitting the drug for approval by the U.S. Food and Drug Administration, performed animal studies with the drug. The FDA did grant approval for the drug in 1991, but only as an anti-nausea medication for patients undergoing anesthesia, chemotherapy, or radiation. Clinical trials were not performed on pregnant women and so the drug was not given approval as a treatment for morning sickness.
GlaxoSmithKline made the decision to proceed with a marketing campaign that lead the medical community and the public to believe that Zofran was a safe treatment for expectant mothers and their unborn children. Without the approval of the FDA, this type of advertising meant that the company was promoting the drug “off-label”.
Birth Defect LawsuitsNot long after this campaign began, GSK allegedly began to receive reports that children had been born with birth defects to mothers who had been treated with Zofran.
In 2014, the first Zofran lawsuit was filed, alleging that a child had suffered due to a birth defect caused by Zofran. Parents allege that the drug caused defects such as atrial septal defect, ventricular septal defect, transposition of the greater vessels, clubfoot, respiratory distress syndrome, kidney defects, cleft lip, and cleft palate. Most children required multiple surgeries to correct the defect and their families believe that their quality of life has suffered.