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Zofran Lawsuits Consolidated by JPML

12 Zofran lawsuits, as well as 42 tag-along actions, were transferred to the District of Massachusetts federal court by the Judicial Panel on Multidistrict Litigation on October 13.

Wednesday, October 14, 2015 - Plaintiffs seeking class certification of their lawsuits filed against GlaxoSmithKline (GSK) related to claims that the company's Zofran medication increased the risk of birth defects for their wish October 13 as the Judicial Panel on Multidistrict Litigation (JPML) transferred the request into an MDL. The anti-nausea drug has been the focus of dozens of lawsuits around the country in the past year as studies and news reports have offered continued evidence of a connection between Zofran's use in pregnant mothers and the development of birth defects. The lawsuits were transferred to the District of Massachusetts federal court.

The transfer includes 12 cases that were originally filed before the JPML, as well as a note of 42 additional cases that are likely to be added in as tag-along actions. The lawsuits will be heard before U.S. District Judge Dennis F. Saylor, IV, who was already presiding over four Zofran actions at the time of the transfer. One of the four before Judge Saylor was also the first action filed in the lawsuits included in the MDL.

The Zofran lawsuits focus on allegations against GSK that claim the pharmaceutical company marketed its strong anti-nausea drug Zofran off-label to be prescribed for morning sickness in pregnant mothers. The plaintiffs have brought evidence that demonstrates a number of studies have shown a strong connection between Zofran an increased risk in the development of birth defects in children. The plaintiffs have claimed that not only should GSK have been aware of the Zofran research being done in connection with birth defects, but that the company may have been aware of the work being done into the serious side effects and chose to protect the marketability of its popular drug.

Zofran is a strong anti-nausea medication made by GSK that was initially intended to be used for surgery and chemotherapy patients suffering from post-operative and post-treatment nausea. Plaintiffs claim that GSK saw an opportunity to market the drug to mothers having difficult pregnancies, but did not go through the FDA and did so off-label. This allowed GSK to avoid testing usually performed by the FDA to avoid side effects such as birth defects from occurring with prescribed medicines.

GSK has had a history of marketing drugs off-label to patients, and settled with the Department of Justice in 2012 for $3 billion that brought to an end a number of charges against the company including many off-label marketing claims. More than two decades of studies have been produced by medical journals, universities and newspaper that have found the increased risk of birth defects relate to Zofran can jump up to 30 percent when the drug is prescribed in the first trimester. The birth defects range from heart deformities, kidney failure, cleft lip, and a number of other serious problems allegedly caused by a fetus' exposure to Zofran in the womb.

The multidistrict litigation will combine the lawsuits included in the motion to transfer before a single federal judge, and likely include more as the news of the certification and the Zofran birth defect information spreads throughout the country. Lawyers for the plaintiffs will coordinate with the District of Massachusetts federal court for pretrial proceedings in the coming weeks.

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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.