## Facts

- Dale Burningham received bilateral artificial hip implants consisting of modular neck and metal-on-metal components manufactured by Wright Medical.
- Burningham alleged the hip devices failed, requiring revision surgeries, and he and his spouse sued for injuries and related damages.
- The plaintiffs asserted, among other claims, strict-liability design defect under Utah products-liability law.
- Wright Medical argued the devices were “unavoidably unsafe” under Restatement (Second) of Torts § 402A comment k, barring strict-liability design-defect claims.
- The suit proceeded in federal district court, which certified questions to the Utah Supreme Court regarding how comment k applies to implanted medical devices, particularly those cleared through the FDA’s § 510(k) process.

## Issues

1. Whether implanted medical devices cleared through the FDA’s § 510(k) process are categorically “unavoidably unsafe” and therefore immune from strict-liability design-defect claims under Utah law.
2. If not categorical, whether comment k applies as an affirmative defense requiring a product-specific factual determination.
3. Whether, and to what extent, the analysis differs for devices receiving FDA premarket approval (PMA) in light of federal preemption.

## Decision

- The court held that implanted medical devices cleared through § 510(k) are not categorically “unavoidably unsafe” under Utah law and are not automatically immune from strict-liability design-defect claims.
- The court held comment k operates as an affirmative defense for § 510(k) devices, to be determined by the factfinder on a case-by-case basis, with the burden on the manufacturer.
- The court declined to decide whether PMA devices are “unavoidably unsafe” as a matter of Utah law because federal law preempts state design-defect claims challenging PMA-approved devices.

## Legal Principles

- Comment k does not create blanket immunity for broad categories of products; it contemplates a product-specific inquiry into whether risks are unavoidable and whether benefits justify those risks in light of feasible alternatives.
- For implanted medical devices that enter the market through FDA § 510(k) clearance, “unavoidably unsafe” status is an affirmative defense that must be proven by the defendant.
- § 510(k) clearance is not a federal safety-and-effectiveness determination and does not, by itself, justify categorical comment k protection.
- For PMA-approved devices, federal preemption generally bars state-law design-defect claims that would impose requirements different from or in addition to federal PMA requirements, making a state-law comment k determination unnecessary.

## Conclusion

Utah law does not grant categorical comment k immunity to § 510(k)-cleared implanted medical devices; instead, manufacturers may assert comment k only as an affirmative defense requiring device-specific proof before the factfinder, while PMA device design-defect claims are largely foreclosed by federal preemption.


Burningham v. Wright Med. Tech., Inc., 448 P.3d 1283 (Utah 2019)