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Questions Of Fact In Zofran MDL Lawsuits

There are a number of questions of fact that bind all the lawsuits filed against GlaxoSmithKline for the connection between their medication Zofran and an increased risk in birth defects.

Wednesday, December 30, 2015 - There are a number of questions of fact that nearly all of the Zofran lawsuits against GlaxoSmitkKline (GSK) share as they head into multidistrict litigation. The plaintiffs’ presentation of these questions and the eventual answering of them during trials will largely determine the outcome of the lawsuits that were consolidated into multidistrict litigation late in 2015. The similarity of all the questions of fact led to the Judicial Panel on Multidistrict Litigation feeling that all the lawsuits were closely related enough to warrant consolidation into an MDL, where they will all be heard together before a single federal judge.

The questions of fact at the heart of the cases all revolve around how GSK dealt in information relating to its anti-nausea medication Zofran and its propensity to contribute to an increase risk in birth defects when taken by pregnant mothers. The main questions of fact in the Zofran lawsuits seek to discover is Zofran indeed causes birth defect, if GSK was aware of the link between their drug and birth defects, whether GSK attempted to hide any information linking Zofran to an increased risk in birth defects, if GSK properly warned its consumers of a possible risk, and whether the drug was marketed off-label, which would have circumvented federal testing that might have uncovered the causal link the drug presents in these lawsuits.

Zofran birth defect research performed by Harvard, Boston University and the medical journals Reproductive Toxicology and The New England Journal of Medicine have all discovered significant links between Zofran use and an increase in the risk for birth defects. A 2014 story published by the newspaper Toronto Star featured 20 Canadian women who had taken Zofran while pregnant and subsequently given birth to children with serious birth defects. Plaintiffs claim that given the amount of studies linking the drug to birth defects, GSK knew of the risk involved with their off-label marketing of the medication and proceeded to push its use for treating morning sickness.

Zofran was originally developed to be used as an anti-nausea medication for cancer patients after undergoing chemotherapy. However, GSK began to market the drugs off-label to physicians to be used to help relieve the symptoms of morning sickness. Zofran was never approved by the FDA for its prescription to pregnant mothers, but plaintiffs are claiming that GSK skipped this step in an effort to increase the revenue brought in by Zofran.

The giant pharmaceutical company was recently involved in a $3 billion settlement with the Department of Justice for taking similar steps with a number of medications that led to serious complications that were prescribed drugs for unapproved uses. Plaintiffs claim a similar strategy was followed in the prescribing of Zofran for morning sickness without FDA approval.

With lawsuits against GSK growing in number across the country, the company filed a motion to transfer all of the claims into multidistrict litigation before the Judicial Panel on Multidistrict Litigation, which was approved on October 13, 2015. This move indicates that GSK anticipates a large number of lawsuits to follow the handful that have been filed already, as the creation of an MDL is a step taken to help the litigative process for large, nationwide lawsuits that share common questions of fact. It is also indicative of GSK's position in the claims as it is not as common for a defendant to file the motion to transfer lawsuits into multidistrict litigation.

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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.