Burningham v. Wright Medical Technology, Inc., 2019 UT 56 (Sept. 5, 2019)

The federal district court certified four questions regarding whether and to what extent implanted medical devices should be immune from strict liability design defect claims under Utah law because they are “unavoidably unsafe.”  Among other things, the supreme court held that a party may invoke the unavoidably unsafe exception, as an affirmative defense, where a device enters the market through the Food and Drug Administration’s 510(k) process on a case-by-case basis.  The decision contains a discussion of when and what jury instructions will be appropriate under different theories of liability.