On Monday, August 22nd, the New Jersey Supreme Court ruled that state law claims alleging generic-drug manufacturers didn't adequately warn of neurological risks for Reglan aren't preempted by federal law. This decision has widened the emerging appellate court split on the issue of generic label preemption, which could make it's way before the U.S. Supreme Court for resolution.
Susan Burnett, partner in the firm's Austin office, commented on the ruling's impact on generic-drug manufacturers as well as consumers in future litigation.
"The 2004 label update was relatively small as it changed from saying that using Reglan beyond 12 weeks hadn’t been evaluated and therefore couldn’t be recommended to warning that Reglan shouldn’t be used after 12 weeks, according to Susan Burnett of Bowman and Brooke LLP. The consumers will have to show that this minor change would have caused doctors to hold off from prescribing the drug for more than 12 weeks in order to show proximate cause, Burnett said."
She went on to say in Law360, “It’s not the end of the ball game — [the drugmakers have] lost the battle but not lost the war...”
Read Law360's full article, NJ Reglan Ruling Widens Generic Label Preemption Split.