Due to a number of inquires, I will give an update this month on the Zofran litigation. Discovery is well underway in the Zofran multidistrict litigation (MDL). The Plaintiffs’ Steering Committee (PSC) is working to review more than 2.3 million pages of documents that GlaxoSmithKline (GSK) has produced so far, including documents relating to an investigation by the Department of Justice into GSK’s off-label promotion of Zofran for use in pregnant women.

In August, U.S. District Judge F. Dennis Saylor granted GSK’s Motion to Dismiss lawsuits filed by women in Georgia, Indiana, Kentucky, Massachusetts, and Oklahoma who alleged that they used a generic form of Zofran. Judge Saylor reasoned that GSK should not be held responsible for injuries caused by a generic version of its product because the law generally recognizes that a manufacturer cannot be held liable for injuries caused by another company’s product.

However, due to the federal regulatory structure of brand and generic drugs, the United States Supreme Court ruled in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), that generic drug manufacturers are insulated from liability for injuries caused by their products, so long as the generic drug’s label matches the branded-drug’s. Combined, these two legal principles leave injured patients without a legal remedy. Judge Saylor’s ruling affects the viability of thousands of unfiled cases around the country. The PSC is working to clear a path for the generic cases to move forward.

There are currently 422 cases filed in the Zofran MDL, which is pending in the U.S. District Court for the District of Massachusetts, under Judge Dennis Saylor. MDL Plaintiffs allege that GSK promoted Zofran for the treatment of nausea and vomiting during pregnancy, when it had never been tested or approved for this use. Plaintiffs claim that their children were born with congenital heart defects or cleft palate after being exposed to Zofran in utero.

Lawyers in the Mass Torts Section at Beasley Allen continue to investigate cases involving children born with a heart defect or cleft palate after first trimester exposure to Zofran. If you would like more information about this litigation, or if your child suffered from a congenital heart defect or cleft palate after prenatal Zofran exposure, contact Roger Smith or Liz Eiland, lawyers in the Section, at 800-898-2034, or by email at Roger.Smith@beasleyallen.com or Liz.Eiland@beasleyallen.com.



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