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.

This content has been archived. It is available through our partners, LexisNexis® and Bloomberg Law.

To view this content, please continue to their sites.

Not a Lexis Subscriber?
Subscribe Now

Not a Bloomberg Law Subscriber?
Subscribe Now

Why am I seeing this?

LexisNexis® and Bloomberg Law are third party online distributors of the broad collection of current and archived versions of ALM's legal news publications. LexisNexis® and Bloomberg Law customers are able to access and use ALM's content, including content from the National Law Journal, The American Lawyer, Legaltech News, The New York Law Journal, and Corporate Counsel, as well as other sources of legal information.

For questions call 1-877-256-2472 or contact us at [email protected]