Zofran Birth Defects Litigation Underway, As Court Issues New Series of Orders

Published on January 4, 2016 by Sandy Liebhard

The multidistrict litigation established in the U.S. District Court, District of Massachusetts, for lawsuits involving Zofran and its alleged link to major birth defects, has begun to move forward. The proceeding’s first Status Conference was convened on December 16^th, after which the Court issued a number of orders that should serve to streamline the litigation and encourage judicial efficiency.

MDL Court Allows Direct Filing of Zofran Lawsuits

At least 200 product liability claims are pending in the federal Zofran litigation, all of which were filed on behalf of children who allegedly developed major birth defects due to their mother’s use of the anti-nausea medication in the first trimester of pregnancy. The proceeding was created this past October, when the U.S. Judicial Panel on Multidistrict Litigation agreed to transfer all federal Zofran birth defects cases to the District of Massachusetts for coordinated pretrial proceedings.

On December 17th, the Court issued three new orders, including a directive that allows plaintiffs to file their Zofran lawsuits directly in the District of Massachusetts. This is intended to eliminate delays associated with the transfer of cases filed in or removed to other federal district courts to multidistrict litigation.

A second order dated December 17^th indicated that GlaxoSmithKline has agreed to “waive formal service of process” for all complaints and summons filed in the multidistrict litigation. A third established the litigation’s Plaintiffs’ Steering Committee.

These orders should allow all Zofran cases filed in the proceeding to move forward efficiently. Additional progress is expected in the coming months, as the Court has already scheduled monthly Status Conferences through May of this year. Dates for those meetings are as follows:

• January 14, 2016
• February 23, 2016
• March 17, 2016
• April 14, 2016
• May 17, 2016

All of the above Conferences will begin at 1:30 p.m.

Zofran Birth Defects Allegations

All of the cases pending in Massachusetts accuse GlaxoSmithKline of concealing Zofran’s alleged association with birth defects and of failing to provide doctors and patients with appropriate warnings about this risk. Plaintiffs further claim that the company illegally promoted the drug as a remedy for morning sickness, even though the U.S. Food & Drug Administration (FDA) has never cleared Zofran for this indication.

Zofran’s only approved uses include the prevention of nausea and vomiting in post-op surgery patients, or in those undergoing certain cancer treatments. In 2012, GlaxoSmithKline agreed to pay $3 billion to resolve illegal drug marketing charges with the U.S. Department of Justice, including allegation that it had promoted Zofran as an off-label treatment for pregnancy-related nausea and vomiting.