On January 9, 2023, the U.S. Court of Appeals for the First Circuit unanimously affirmed a victory of Williams & Connolly client GlaxoSmithKline LLC (“GSK”) in multidistrict product liability litigation where a group of more than 400 plaintiffs attempted to attribute various birth defects, including heart defects and cleft palate, to the use of Zofran, an anti-nausea medication.  

In June 2021, the U.S. District Court for the District of Massachusetts granted GSK’s motion for summary judgment on federal preemption grounds, holding that federal law, including the Food and Drug Administration’s (FDA) decisions about Zofran’s labeling, bars plaintiffs’ claims. Specifically, the court found that the FDA had been asked repeatedly about a warning label for pregnant women and had rejected adding that language, despite knowing that Zofran had been prescribed off-label to pregnant women for years. Williams & Connolly led the briefing and strategy on preemption on behalf of GSK before the trial court. As Law360 reported, this ruling “decimate[d] the MDL” ahead of the first bellwether trial, and the court closed the case.  

Plaintiffs appealed to the First Circuit. Williams & Connolly led the briefing on appeal. Lisa Blatt presented oral argument in July 2022. In its 35-page opinion affirming the district court’s ruling, the First Circuit agreed that federal law preempts the plaintiffs’ state-law failure-to-warn claims.

The victory has been widely covered by the press, including by Law360, Reuters, and Bloomberg Law. 

The Williams & Connolly team representing GSK included Amy Saharia, Lisa Blatt, and Jami King.