STORY FROM: Drugs & Medical Devices
GSK Denied Summary Judgment on Preemption Basis in Zofran MDL
February 7, 2019
BOSTON — A Massachusetts federal judge denied GlaxoSmithKline summary judgment on the basis of preemption in the Zofran MDL, ruling there are questions of fact as to whether the FDA would have rejected a stronger warning regarding the safety of ingesting the drug while pregnant.
In a Feb. 5 order, Judge F. Dennis Saylor IV of the U.S. District Court for the District of Massachusetts said GSK has not proved that the Changes Being Effected process was unavailable to it to make more substantial warnings, or that there is “clear evidence” that the FDA would not have approved a label ...