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Toronto Star Zofran Report Significant In Plaintiffs' Arguments

A 2014 investigative report conducted by the Toronto Star identified at least 20 women that had suffered birth defects allegedly connected to physician's prescribing the women Zofran to help treat morning sickness symptoms.

Wednesday, September 30, 2015 - One of the main pieces of evidence being employed by plaintiffs in the Zofran birth defects lawsuits comes from an investigative report conducted by Canadian newspaper The Toronto Star. The pharmaceutical company GlaxoSmithKline (GSK) has been the subject of dozens of lawsuits across the U.S. regarding research supporting a link between the company's anti-nausea medication Zofran and birth defects discovered in the children of mothers who took the drugs while pregnant.

The 2014 Toronto Star story focused on women who had been prescribed the drug during pregnancy in Canada. It reported that at least 20 Canadian women who were prescribed Zofran while pregnant had given birth to children with defects ranging from physical deformities to death. These discoveries were made after the paper looked into extensive data provided in the U.S. Food and Drug Administration (FDA)'s public side-effect database, in which specific results pertaining to Canadian patients are held.

The report claimed that because most women experience nausea connected to pregnancy during the first trimester, they were prescribed Zofran during the time the fetus was most vulnerable to developing birth defects as a result of the medication. This was in large part connected to women who had severe vomiting early in their pregnancy that could only be quelled with the strong anti-nausea medicine oftentimes used following surgeries and chemotherapy.

The story also pointed out that the doctors had been prescribing Zofran to pregnant women even though it had not been properly vetted by the FDA. Attorneys representing plaintiffs in the lawsuits claim that GSK intentionally avoided having the medication tested by the FDA and marketed the drugs off-label to physicians for the treatment of morning sickness symptoms. Zofran was consequently never tested for links with birth defects until after it had been regularly prescribed to pregnant mothers.

The Toronto Star report has been referenced in the plaintiffs arguments thus far in the Zofran proceedings along with birth defect research studies conducted by Harvard, Boston University and a number of medical journals which have all found correlations between the use of Zofran and an increased risk of birth defects. The investigative report is largely responsible for alerting the public to the risks of taking Zofran while pregnant and helped spike the current wave of lawsuits being filed across the country.

GSK has made large settlements with plaintiffs in the past regarding their off-label marketing tactics. In 2012, the company paid out more than $3 billion as a result of a litany of marketing and advertising violations including off-label market for a number of medications. Zofran plaintiffs are seeking damages from the company for what they believe are similar tactics employed by the company to boost the profitability of the anti-nausea medication at the expense of the health of unborn children.

Zofran lawsuit filed nationwide are scheduled to be presented as part of a motion to transfer before the Judicial Panel on Multidistrict Litigation October 1. The consolidation request came from the GSK, which is asking for the lawsuits to be transferred to the Eastern District of Pennsylvania federal court before U.S. District Judge Cynthia M. Rufe. The decision of the potential consolidation of the lawsuits will come in a matter of week following the hearing.

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Onder, Shelton, O'Leary & Peterson, LLC is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. Onder, Shelton, O'Leary & Peterson has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others, and other law firms throughout the nation often seek its experience and expertise on complex litigation.