A federal judge has cleared the way for a court challenge to the Food and Drug Administration’s decision to classify pedicle screw fixation devices used in spinal fusion surgery under Class II — the same low-regulation category as surgical sutures — after finding that consumers have standing to bring such an action under the Food, Drug and Cosmetic Act.
Senior U.S. District Judge Louis C. Bechtle’s ruling is a major victory for thousands of plaintiffs who are currently suing over injuries they sustained from implanted bone screws because it packs the potential to rob defense lawyers of a powerful trump card.
