We have previously reported that the Zofran multidistrict litigation (MDL) was formed last fall. Since then, Plaintiffs have continued to file lawsuits on behalf of children born with birth defects as a result of in utero exposure to Zofran. Thus far more than 250 lawsuits have been filed in the Zofran MDL, which is pending in the U.S. District Court for the District of Massachusetts.
As you may recall, Zofran is a powerful anti-nausea medication approved by the U.S. Food and Drug Administration (FDA) for patients suffering from nausea as a side effect of chemotherapy and following surgery. However, for years, GlaxoSmithKline (GSK) promoted it to doctors for the treatment of nausea and vomiting during pregnancy, despite the fact that it has never been approved as safe and effective for that use. Doctors relied on GSK’s representations about its product. Even after GSK paid $3 billion to settle criminal and civil liabilities relating to that improper promotion, Zofran continues to be prescribed routinely for pregnant women suffering from morning sickness.
Earlier this year, the Court denied GSK’s Motion to Dismiss all of the pending Zofran cases. GSK argued that because the FDA already rejected a Citizen Petition seeking to reclassify Zofran from pregnancy category B to category C, D, or X and notify health care providers that Zofran use during pregnancy may lead to birth defects, the plaintiffs’ claims were preempted. In other words, Plaintiffs could not argue that GSK should have included a warning about the potential for birth defects because the FDA rejected a citizen petition with a similar request.
Judge Saylor correctly denied GSK’s motion, ruling that just because the FDA rejected the citizen petition did not mean that the FDA would reject a proposed label change by GSK, since GSK obviously has access to more information about its drug than an ordinary citizen. While Judge Saylor did not rule on the merits of GSK’s motion, he did rule that Plaintiffs are entitled to an opportunity to investigate how the FDA would have responded to GSK’s proposal had GSK submitted all of the information at its disposal.
The Zofran MDL is moving forward with discovery. The lawyers on the Plaintiffs Steering Committee (PSC) have already negotiated with GSK to develop a Product Identification Fact Sheet and Plaintiff Fact Sheet (PFS) that each individual Plaintiff will complete. Once a Plaintiff completes the Product ID Fact Sheet and PFS, GSK will produce a Defendant Fact Sheet (DFS). Additionally, the PSC is working on a document production protocol, whereby GSK will provide the PSC with documents relating to the development, approval, and promotion of Zofran.
Lawyers in our firm’s Mass Torts Section continue to investigate cases involving children born with a heart defect or cleft palate after in utero exposure to Zofran. If you would like more information about this litigation, or if you or someone you know has had a family member who suffered from a congenital heart defect or cleft palate as a result of prenatal Zofran exposure, contact Liz Eiland or Roger Smith, lawyers in our firm’s Mass Torts Section, at 800-898-2034 or by email at Liz.Eiland@beasleyallen.com or Roger.Smith@beasleyallen.com.
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