Summary
The Utah Supreme Court answered certified questions concerning whether Utah's unavoidably unsafe products doctrine applies to implanted medical devices. The court held that for devices cleared through the FDA's 510(k) process, the doctrine may apply as an affirmative defense determined by the factfinder on a case-by-case basis, rather than categorically as a matter of law. The court did not address PMA-approved devices because federal law preempts state tort claims involving those devices.
Topics
Practice areas
Questions Presented
- Whether Utah's unavoidably unsafe exception to strict products liability applies to implanted medical devices.
- Whether the exception categorically applies to all implanted medical devices or instead applies case by case.
- What analysis governs an unavoidably unsafe affirmative defense involving a medical device cleared through the FDA's 510(k) process.
- Whether application of the exception requires a showing that the device entered the market through the FDA's premarket approval process rather than the 510(k) process.
Holdings
- Under Utah law, an implanted medical device cleared through the FDA's 510(k) process is not categorically immune from strict-liability design-defect claims under the unavoidably unsafe exception.
- For an implanted medical device cleared through the 510(k) process, the unavoidably unsafe exception is an affirmative defense that must be determined by the factfinder on a case-by-case basis.
- To establish the unavoidably unsafe defense to a design-defect claim involving a 510(k)-cleared implanted medical device, the manufacturer must prove by a preponderance of the evidence that, when made, the product could not be made safe for its intended use even with the best available testing and research, and that the product's benefits justified its risks.
- The court declined to decide whether premarket-approval medical devices are unavoidably unsafe as a matter of law because federal law already preempts state-law tort claims involving such devices.
Key quotations
“Accordingly, the answer to the second question is that courts applying Utah law should treat this exception as an affirmative defense to be determined by the factfinder on a case-by-case basis.” (¶31)
“the manufacturer must prove by a preponderance of the evidence that (1) when the product was made, it could not be made safe for its intended use even applying the best available testing and research, and (2) the benefits of the product justified its risk.” (¶39)
Factual background
Dale Burningham had artificial hip implants surgically implanted in both hips. Components of the implants allegedly failed over time, requiring several revision surgeries. The Burninghams alleged design defects in a Profemur Modular Neck and metal-on-metal Conserve components manufactured by Wright Medical, and asserted strict-liability design-defect claims among other theories. The devices were Class III devices cleared through the FDA's 510(k) process rather than approved through the premarket approval process.
Procedural history
The Burninghams sued Wright Medical in federal court after Dale Burningham's hip implants allegedly failed and required revision surgeries. Wright Medical moved to dismiss, arguing that Utah's unavoidably unsafe doctrine categorically immunized the implants from strict-liability design-defect claims. The federal district court certified four unresolved questions of Utah law to the Utah Supreme Court, which answered them without resolving the underlying dispute.
Remand instructions
The Utah Supreme Court answered the certified questions conditionally and did not resolve the underlying federal litigation. The federal district court was to apply the answers in the pending case.