Design Defect, Warning Claims Survive Preemption Argument in Suboxone Film MDL

CLEVELAND — The judge overseeing the federal docket for Suboxone film dental decay lawsuits has refused to dismiss a plaintiff’s design defect claim, ruling that he has adequately alleged the existence of a safer product that would be just as effective in treating opioid dependence.

On Dec. 31, Judge J. Philip Calabrese of the U.S. District Court for the Northern District of Ohio also allowed the plaintiff’s failure-to-warn claim to proceed, ruling that further discovery is needed to determine whether defendants had “newly acquired information” under the FDA’s Changes-Being-Effected regulation that would have warranted a post-approval label change warning of …