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Zofran Lawsuits Top 30 Nationwide As GSK Spokesperson Denies Liability

The number of lawsuits against GSK continues to climb steadily, while a spokesperson for the company denies the actions taken by the defendant render them liable for claims filed by the plaintiffs.

Wednesday, August 19, 2015 - The total number of Zofran birth defect lawsuits filed against pharmaceutical manufacturer GlaxoSmithKine (GSK) has topped 30 as women nationwide take action against the off-label marketing off the anti-nausea drug as a morning sickness remedy. The number of lawsuits has risen steadily from single digits towards the beginning of the summer to the dozens that are now pending against GSK, which requested for the lawsuits against the company to be consolidated into multidistrict litigation in early July. At the time of the proposed motion to transfer, only 12 lawsuits were filed against GSK.

The plaintiffs filing claims against GSK allege that the pharmaceutical giant promoted the anti-nausea medication Zofran off-label for the treatment of morning sickness in pregnant mothers. The drug was originally approved by the FDA in 1991 to combat nausea produced by surgeries and chemotherapy. The drug was never approved however to treat morning sickness, and plaintiffs are claiming that GSK's off-label marketing of the drug for that purpose contributed to the amount of birth defects that have allegedly occurred in tandem with the prescription of the rug to pregnant mothers.

Plaintiffs are not only relying on their own experiences to prove the connection between Zofran and an increased risk for birth defects, as attorneys representing them have produced Zofran birth defect research from both universities and medical journals that support their claims. The Zofran birth defect research, which has appeared in publications such as Reproductive Toxicology and Pediatric Emergency Care and been documented in studies performed by Harvard and Boston University, has found the rate of children born with defects such as congenital heart problems and cleft lips to increase up to a factor of two when the medication is taken in the first trimester.

The allegations against GSK also claim that given the Zofran birth defect research available, which dates back to the early 2000s, the company either should have been aware of the potential risk and attached an accompanying warning label or that the company intentionally ignored the research and continued to market the drug off-label aware of the risk associated with the medication. Though not involving off-label marketing, GSK has already dealt with litigation related to Zofran, settling a 2005 lawsuit regarding the drug for $150 million. The company also settled a massive lawsuit involving the Department of Justice that did focus on the company's off-label marketing practices for $3 billion in 2012.

Despite the claims made by over 30 plaintiffs thus far, GSK is steadfast in its belief that the company shares no responsibility in the possible link between the drug and birth defects, or the manner in which the medication was prescribed. A spokesperson for GSK recently claimed that the company did not feel that it's marketing of the drug unapproved to physicians was in any way inappropriate. “In recognition of the fact that prescription medicines have inherent risks, a manufacturer is not to be subject to liability when someone experiences a side effect when the medicine is accompanied by appropriate labeling,” said GSK spokesperson Marti Skold Jordan.

The lawsuits against GSK are up for multidistrict litigation and whether they will be consolidated into an MDL will be determined in the near future by the Judicial Panel on Multidistrict Litigation. The number of lawsuits are still expected to rise over the coming months and news of the lawsuits and possible MDL certification spreads to potential plaintiffs affected by the birth defect risks of the Zofran medication.

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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.