Zofran Case Consolidation requested by GlaxoSmithKline

glaxosmithklineZofran Birth Defect Lawsuit Consolidation has been requested by GlaxoSmithKline (GSK), the maker of Zofran. GSK faces several lawsuits which allege that the drug maker failed to warn that taking the drug during the first trimester of pregnancy could lead to birth defects.

GSK wants Pennsylvania MDL

GlaxoSmithKline filed a motion on July 6, 2015 requesting that all current and future federal Zofran birth defect lawsuits be consolidated in the Eastern District of Pennsylvania before one judge.

GSK noted in the filing that twelve Zofran birth defect claims have been filed in at least eight federal courts. GSK also said it expect more actions to be filed nationwide.

Arguments for Multi District Litigation Court

Multi district litigation courts (MDL) are generally thought to provide benefits for all parties in a given litigation, and to lessen burden on the courts. Motions for MDLs are usually granted on the merits of whether the arrangement allows for greater efficiency and less duplication of discovery, research, expert testimony, court filings, etc. , as well as cutting down on potentially conflicting court rulings.

In arguing for the MDL, GSK said that each lawsuit shares “numerous complex and common questions of fact.”  In particular, plaintiffs in the Zofran cases allege GSK unlawfully promoted Zofran as a “safe and effective” morning sickness treatment, without ever receiving FDA approval for Zofran use during pregnancy. Plaintiffs also claim GSK  ignored mounting evidence of Zofran’s link with major birth defects, and failed to warn the public or health community of the drug’s (alleged) risks. Plaintiffs claim that they were prescribed Zofran during the first trimester to prevent the symptoms of nausea and vomiting, and then gave birth to children with major birth defects caused by Zofran.

Zofran Heart Defects

Most Zofran birth defect lawsuits claim damages in relation to congenital heart defects. Families have named several “hole in the heart” defects, such as ventricular and atrial septal defects. Plaintiffs also cite some major European studies that have found a marked increase in the risk for such “cardiac septal defects” among babies exposed prenatally to Zofran. Claims have also been filed for cleft lip and cleft palate, birth defects linked to Zofran by a 2012 Harvard University study.

Zofran Cases filed in Several States

In its motion for an MDL court, GSK writes that Zofran birth defect lawsuits have already been filed in Alabama, Arkansas, Louisiana, Massachusetts, Montana, New Jersey, Ohio and Texas federal courts. Claims filed in state, rather than federal courts, could later be removed to federal court. Cases will then be transferred to the Zofran Products Liability Litigation MDL.

GSK wants Judge Rufe

GSK argues that Judge Cynthia M. Rufe, who has managed two other Multidistrict Litigations (MDL) involving pharmaceutical drugs linked to birth defects (to the detriment of plaintiffs’ claims, many  would argue), should be appointed as judge to manage the Zofran MDL. The motion names Judge Paul Diamond as an alternative. Diamond presided over an MDL involving thalidomide between 2011 and 2013.



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