The FDA has taken recent steps that may, or may not, affect product liability litigation.  We’re discussing the “may” aspect.  For purely regulatory analysis, plenty of other commentary is available.

These actions occurred on September 7, 2023, and involve three “draft guidances” bearing on the “§510(k)” substantial equivalence clearance process for medical devices.  Any litigator with even passing knowledge of medical device preemption knows that this − more properly, a prior (1982) version − is the process that the Supreme Court stated, was “focused on equivalence, not safety” in Medtronic, Inc. v. Lohr, 518 U.S. 470, 493 (1996) (emphasis original).Continue Reading Tort-Related Implications of Recent FDA Device Draft Guidances