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Zofran manufacturer GlaxoSmithKline (GSK) wants the court to dismiss hundreds of Zofran birth defect lawsuits.

Though a number of studies have linked Zofran (ondansetron), when taking by expectant moms, to an increased risk of birth defects, the company maintains that there is insufficient evidence to prove a connection. They filed a motion on December 11, 2015, asking the Court to dismiss all failure-to-warn claims.

GSK Seeks Early Dismissal of Hundreds of Cases

The U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federally filed Zofran lawsuits in the District of Massachusetts in October 2015. The MDL has been underway only a short time, but already there are over 200 Zofran lawsuits pending there.

GSK is taking action quickly in an effort to avoid litigation on their anti-nausea drug, which was initially approved in 1991 for the treatment of nausea and vomiting in patients going through surgery or cancer treatments. The FDA never cleared the drug for use in pregnant women, but GSK ran an aggressive advertising campaign that plaintiffs allege sought to to convince doctors and pregnant women that the drug was safe for the treatment of morning sickness.

The U.S. Department of Justice (DOJ) brought charges against the company for, among other things, their aggressive marketing of Zofran to pregnant women, which was illegal because the drug was never approved for that purpose. The company agreed to a fine of $3 billion in 2012.

Judge Dennis Saylor was scheduled to review GSK’s motion to dismiss on January 14, 2016, during a status conference. According to their motion, the defendants ask the court to dismiss “all causes of action against it in this multidistrict litigation as preempted by federal law.”

Defendant argues that there are no human studies specifically addressing the birth defect risk of taking Zofran during pregnancy. This, despite several studies that indicate a risk, including the following:

  • 2006: Scientists found that Zofran can cross the human placental barrier.
  • 2012: Researchers analyzed data from the National Birth Defects Prevention Study on about 4,500 women, and found that treatments with drugs like Zofran were associated with a potential increased risk of cleft lip and palate.
  • 2013: Australian researchers, after evaluating pregnant women using Zofran, found a small increased risk of a major birth defect in those using it during the first trimester.
  • 2014: Researchers evaluated data from over 1,300 infants born to women who took Zofran during early pregnancy, and found a significant increased risk for cardiovascular defects.

Plaintiffs Respond to Motion to Dismiss

The plaintiffs in the Zofran MDL, in their response dated January 5, 2016, assert that GSK’s motion to dismiss is “unripe, unprecedented and violates established federal law.” They add that because GSK never tried to gain FDA approval for Zofran’s use in pregnant women, and because discovery in this MDL hasn’t even started yet, the company still has “exclusive control of much of the evidence relevant to the foreseeable risks of Zofran use during pregnancy.”

GSK’s motion is critically flawed, the plaintiffs state, and should be dismissed.

One Comment

  1. Gravatar for Jay

    Even if GSK were ultimately successful in convincing the court that the MDL was preempted by federal law (unlikely), all affected women would still have class action rights in state courts.

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