Colin Kelly, partner in the Products Liability and Litigation & Trial Practice Groups, was quoted in a Law360 article discussing a proposed new FDA rule that requires the makers of metal-on-metal hip implants to prove the devices are safe by having to file either a premarket approval application or a product development protocol. According to the article, some attorneys argue that even if these companies follow this new rule, it will embolden plaintiffs to partake in massive multidistrict litigation to try and prove the FDA never knew whether the devices were effective.
“Certainly there are legal and evidentiary mechanisms that, once the FDA adopts a rule, would make it easier for the plaintiffs to try to get in,” Kelly said.
“As a general matter, in this high-stakes litigation, with a change in FDA regulations, the plaintiffs will try to find every mechanism possible to make that an issue in the case,” he added.