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Direct Filing Allowed In Zofran MDL

The judge presiding over the Zofran MDL against GlaxoSmithKline allowed for the direct filing of Zofran lawsuits to helped streamline the litigative process for potential plaintiffs.

Wednesday, December 23, 2015 - The direct filing of lawsuits has been allowed in the multidistrict litigation covering cases filed against GlaxoSmithKline for alleged birth defects caused by their Zofran anti-nausea medication. There are now more than 100 lawsuits involved in the MDL, which was consolidated by the Judicial Panel on Multidistrict Litigation on October 13. The direct filing will help streamline the litigative process leading up to the multidistrict litigation and make it easier for plaintiffs to join the MDL.

The direct filing of lawsuits was announced in an order given by U.S. District Judge F. Dennis Saylor IV and allows potential plaintiffs to file their Zofran lawsuits directly to the MDL instead of having to first file those suits through their local district court. There have been Zofran lawsuits filed from states all over the country, and now those plaintiffs will be able to take their grievances directly to the District Court of Massachusetts where the MDL is centralized. The direct filing order is in line with the rest of the MDL process, which is aimed at taking a large number of lawsuits with similar questions of fact and expedite the process by which they are handled in court.

Zofran was initially developed to help treat nausea symptoms in chemotherapy and surgery patients after undergoing procedures. The medication is one of the strongest options for anti-nausea treatments, and for this quality was targeted for use to treat morning sickness symptoms. Unfortunately, more Zofran research is pointing to the existence of a link between the drug and an increased risk of birth defects.

The plaintiffs in the Zofran lawsuits claim that GlaxoSmithKline, a major pharmaceutical manufacturer that settled with the Department of Justice for $3 billion over off-label charges filed against the company in 2012, marketed Zofran to help treat women experiencing morning sickness symptoms during pregnancy. The medication, which was approved by the FDA for a number of uses including staunching nausea due to chemotherapy, was never approved or tested by the FDA for use during pregnancy.

This type of off-label marketing is the type of measure that is often taken by pharmaceutical companies attempting to profit from medications not yet approved for specific uses, and the dangers it can pose to patients spurred the FDA to hold a public meeting to discuss the practice's pros and cons. The plaintiffs in the lawsuits claim that the off-label marketing violated their right to know the effects the drugs would have on them, which should have been listed on the warning label. The lawsuits claim that as a result of the off-label marketing, the testing that could have prevented the birth defects from developing during pregnancy were ignored and led to irreparable harm to a steadily growing number of plaintiffs.

Plaintiffs also claim that GlaxoSmithKline, if not initially aware, eventually learned of the serious affect Zofran was having on pregnant mothers and chose not to warn patients of the birth defect risk associated with the medication. This claim is repeatedly referenced in the lawsuits along with the failure to warn allegations against the British pharmaceutical company.

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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.