FDA Guide on 510(k) Changes Will Help Device Preemption: Attorney

FDA’s newly issued draft guidance that updates recommendations on when device makers need to submit a new 510(k) after making device modifications has special meaning to lawyers representing companies in product liability lawsuits, according to Reed Smith lawyer James Beck. In a new blog post, Beck welcomes the draft guidance’s numerous statements about when changes to the design and warnings of 510(k) medical device obligates their manufacturers to resubmit their products for additional FDA clearance prior to marketing. According to Beck, “if a product change requires prior FDA review and assent, then that change cannot be mandated by common law tort actions... The guidance is useful in that it provides a more comprehensive explication of the regulations, and thus more useful understanding of when a requirement for prior FDA submission of a device change gives rise to implied impossibility preemption under Mensing, Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), and Wyeth v. Levine, 555 U.S. 555 (2009).”

Beck says that it is inevitable that implied impossibility preemption will come to 510(k) medical devices, especially now that three circuits have already applied it outside of generic drugs.  “Unlike express preemption (such as Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)), implied preemption isn’t limited to the express terms of particular statutes, and as we discussed in the “Break Glass” post, express and implied preemption operate independently of one another, so Lohr doesn’t restrict the operation of implied preemption,” he writes. “Since the key to impossibility preemption, as Mensing held, ‘is whether the private party could independently do under federal law what state law requires of it,’ the draft guidance provides a wealth of FDA regulatory explanation of why certain types of changes to the design, labeling, and other features of 510(k) medical devices necessitate prior FDA clearance − and thus cannot be demanded by plaintiffs in common-law product liability litigation.”