448 P.3d 1283
Utah2019Background:
- Dale and Lana Burningham sued Wright Medical alleging design defects in bilateral hip implants (Profemur® modular neck and Conserve® metal-on-metal components) after component failures and revision surgeries.
- Wright moved to dismiss, arguing Utah’s "unavoidably unsafe" (Comment k) doctrine immunizes implanted devices from strict liability design-defect claims, relying on Utah precedent that categorically protected prescription drugs.
- The federal district court found no controlling Utah law on implanted devices and certified four questions to the Utah Supreme Court.
- The devices at issue are Class III medical devices that entered the market via the FDA 510(k) clearance process (substantial-equivalence review), not the more rigorous PMA approval process.
- The court considered differences between PMA (rigorous safety/efficacy review) and 510(k) (equivalence-focused, no safety approval) central to whether Comment k should apply.
Issues:
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Comment k (unavoidably unsafe) applies to implanted devices | Burningham: Should not be categorically applied to implants | Wright: Same rationale as for drugs; categorical immunity for implants | Conditionally yes: it can apply, but not as categorical immunity for 510(k) devices |
| Whether immunity is categorical or case-by-case | Burningham: Case-by-case | Wright: Categorical (like Grundberg for drugs) | Case-by-case; treated as an affirmative defense for 510(k) devices |
| Proper test/analysis if case-by-case | Burningham: Adopt Tansy three-part test (incapable of being made safe; social need; proper manufacture/warnings) | Wright: Use Model Utah Jury Instruction (MUJI) formulation | Use MUJI two-part test (incapable of being made safe despite best testing; benefits justify risk); manufacturing/warning defects remain separate claims that defeat the defense if proved |
| Does PMA vs 510(k) clearance determine application | Burningham: PMA distinction matters | Wright: Not necessary to require PMA | PMA devices are already preempted under Riegel (court therefore does not decide whether PMA devices are unavoidably unsafe as a matter of law); 510(k) devices are not categorically immune |
Key Cases Cited
- Grundberg v. Upjohn Co., 813 P.2d 89 (Utah 1991) (extended Comment k to categorically protect FDA‑approved prescription drugs from strict design‑defect liability)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (MDA preempts state‑law tort claims for PMA‑approved devices)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (U.S. 1996) (510(k) clearance focuses on substantial equivalence, not FDA safety/efficacy approval)
- Tansy v. Dacomed Corp., 890 P.2d 881 (Okla. 1994) (treats Comment k as an affirmative defense with a device‑specific test)
- Schaerrer v. Stewart's Plaza Pharmacy, Inc., 79 P.3d 922 (Utah 2003) (Comment k immunity does not protect against manufacturing or inadequate‑warning claims)