Discovery will soon get underway in the federal Zofran birth defects litigation. According to a Scheduling Order issued on November 10th in the U.S. District Court, District of Massachusetts, that process will encompass five distinct phases.

Zofran Discovery Phases

Discovery is the formal investigation that the parties to a lawsuit conduct before trial. The centralization of all federal Zofran birth defects cases in the District of Massachusetts will enable all of these cases to undergo a coordinated discovery process. The five phases outlined in the Court’s November 10th Order include:

  • Phase 1:  Release of product identification fact sheets, plaintiff fact sheets and defendant fact sheets must be released as required by Orders dated May 26, 2016.
  • Phase 2: Release of electronically stored information pertaining to the alleged link between Zofran and birth defects, as well as all preemption issues. Expert and fact discovery will likely be required in Phase 2.
  • Phase 3: General causation issues and whether any regulatory action on the part of the FDA preempts any of the plaintiff’s claims. This phase is to begin immediately.
  • Phase 4: Discovery concerning individual causation, product identification or damages. To begin on February 1, 2017.
  • Phase 5: Any remaining potentially relevant issues. Date to be determined.

Zofran Allegations

Court documents indicate that around 300 Zofran lawsuits are now pending in the consolidated proceeding underway in Massachusetts. All of the claims were filed on behalf of children who were allegedly born with serious birth defects due to their mothers’ use of the anti-nausea drug during pregnancy. GlaxoSmithKline is accused of concealing knowledge that prenatal exposure to Zofran creates an “unreasonable risk of harm” to a developing fetus. Plaintiffs also allege that Glaxo aggressively and improperly marketed Zofran as a safe and effective remedy for pregnancy-related nausea and vomiting, even thought the U.S. Food & Drug Administration (FDA) never approved the drug for this indication.

Zofran is only approved to treat nausea and vomiting experienced by post-op surgery patients, or those undergoing certain cancer treatments. However, research indicates that roughly 1 million expectant mothers in the U.S. are prescribed the drug every year to combat nausea and vomiting related to pregnancy. A number of recent studies have suggested that a baby may be  more likely to develop serious birth defects, including oral clefts and heart defects, when Zofran is take in the first trimester of pregnancy.

Bernstein Liebhard LLP continues to offer free legal reviews to individuals who may be interested in filing a Zofran lawsuit for birth defects. To learn more, please call 877-779-1414.

Published November 14, 2016 by