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GSK Files To Dismiss All Zofran MDL Lawsuits

The company is arguing that a clear evidence preemption necessitates the dismissal of the claims, while plaintiffs accuse the defendant of trying to apply a broad precedent to a handful of lawsuits.

Wednesday, January 20, 2016 - GlaxoSmithKline (GSK) is moving to dismiss more than 200 of the Zofran birth defect lawsuits currently pending against the company in multidistrict litigation. The company originally filed the motion to dismiss the lawsuits on December 11 before the District of Massachusetts federal court, where the MDL was centralized. The Judicial Panel on Multidistrict Litigation transferred the Zofran birth defect lawsuits to the court on October 13, sending over 15 lawsuits with a few dozen tag-along actions. The number has now grown to more than 200 after only three months of consolidation.

GSK is the main defendant in the MDL and claims that the evidence brought forth by the plaintiffs does not constitute grounds for legal actions a GSK has produced a number of their own studies that claim Zofran is not dangerous for pregnant mothers to take. GSK is using what is called the clear evidence preemption to attempt to toss the lawsuits brought against the pharmaceutical company. The defendant is arguing that the requests by plaintiffs for the labeling they would have required on Zofran would have caused the drug to lose approval from the FDA in entirety for the drug and that based on this GSK would not have been able to use the labels.

Plaintiffs are not buying this argument from GSK however, claiming that the company chose the wording from a select few lawsuits that it could build the clear evidence claim around. They filed an opposition to GSK's motion to dismiss in which attorneys for the plaintiffs claimed that unless GSK could prove that this clear evidence preemption was true for all the cases involved, the trial should be allowed to proceed.

Plaintiffs claim that the anti-nausea drug Zofran was prescribed off-label by GSK and led to birth defects in pregnant mothers who were given the drug to help combat morning sickness symptoms. The claims are backed by studies that display a possible link between Zofran and an increased risk in birth defects for unborn children exposed to the drug. The amount of evidence became so overwhelming in recent years that enough lawsuits were filed nationwide to push the litigation into an MDL. Now there are more than 200 lawsuits included in the MDL, with substantial jumps taking place in the number of lawsuits every filing session.

The plaintiffs allege that GSK bypassed FDA testing by promoting the use of Zofran to treat severe morning sickness symptoms directly to doctors. The bypassing of the testing is likely what allowed for the correlation between Zofran and birth defects not to be caught before allegedly hundreds of children were adversely affected by the medication. Attorneys for the plaintiffs have pointed out that this isn't the first time GSK has been caught red-handed attempting to use off-label marketing techniques. In 2012, the company had to pay out a total of $3 billion total in fines and settlements after the Department of Justice launched a massive investigation into the company's illegal activities. Many of these included the off-label marketing of drugs, amazingly Zofran being one of the medications involved in the 2012 investigations.

The ruling on the motion to dismiss has not been ruled upon yet by the federal judge presiding over the MDL. The motion however does not seem to be a legitimate threat to the hundreds of lawsuits filed against GSK, and the MDL is expected to proceed with pretrial proceedings as it gains steam in 2016.

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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.