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Zofran Birth Defect Cases Consolidated in Boston, Massachusetts

The United States Judicial Panel on Multi-District Litigation (JPML) recently assembled to determine whether the cases known as In Re: Zofran (ondansetron) Products Liability Litigation should be given Multi-District Litigation (MDL) treatment, and if so, where the litigation should be consolidated. Granting MDL treatment consolidates all federal lawsuits filed across the United States into one centralized district. This consolidation streamlines the pretrial discovery process, allowing the parties to avoid duplicative discovery and inconsistent rulings from different judges.

Plaintiffs in the Zofran litigation allege that GlaxoSmithKline (GSK), the manufacturer of Zofran, fraudulently misrepresented the safety of its anti-nausea drug for pregnant women to prescribing doctors, resulting in unsuspecting pregnant women ingesting the drug and unknowingly harming their unborn babies. The most common birth defects include cleft palate, spina bifida and heart defects. It is further alleged that GSK marketed Zofran to pregnant women without FDA approval, as the FDA only approved the drug to treat post-operative surgery patients and certain patients undergoing cancer treatments.

On October 13, 2015, the JMPL agreed with the parties that the cases should be consolidated for discovery purposes and ordered all federal cases to be transferred to the District of Massachusetts before US District Judge F. Dennis Saylor. There are currently about 60 cases before Judge Saylor, but with the establishment of MDL No. 2657, additional cases are expected to be filed shortly.

COPYRIGHT © 2020, STARK & STARKNational Law Review, Volume V, Number 315


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Stark & Stark’s Litigation group includes accomplished trial lawyers in both bench and jury trials, appeals, and administrative proceedings. They are experienced arbitrators and mediators. These lawyers are licensed in a number of jurisdictions including New Jersey, Pennsylvania, New York, Delaware, and beyond. 

We routinely litigate multi-million dollar corporate and commercial cases in multiple state and federal jurisdictions. We also serve as local counsel in complex corporate litigation matters for law firms without a presence in our...