1st Cir. Upholds Award of Summary Judgment to GSK in Zofran Birth Defect MDL

BOSTON — The 1st Circuit U.S. Court of Appeals has upheld an award of summary judgment to GlaxoSmithKline LLC in the Zofran birth defect multidistrict litigation, ruling there was no “newly acquired evidence” that would have allowed GSK to add a stronger warning to the drug’s label via the Changes Being Effected process.

In a Jan. 9 opinion, the appellate panel found Japanese studies proffered by plaintiffs did not show a statistically significant relationship between Zofran and observed birth defects in animal subjects; therefore, the studies did not constitute “newly acquired evidence”.

Zofran is an FDA-approved prescription drug for the …