Utah Supreme Court
Does Utah's unavoidably unsafe doctrine protect all implanted medical devices? Burningham v. Wright Medical Explained
Summary
The federal district court certified questions about whether Utah’s unavoidably unsafe doctrine immunizes implanted medical devices from strict liability design defect claims. The Utah Supreme Court held that 510(k)-cleared devices are not categorically immune but may raise unavoidably unsafe as an affirmative defense.
Practice Areas & Topics
Analysis
The Utah Supreme Court addressed a significant question for medical device litigation in Burningham v. Wright Medical, determining when implanted medical devices receive protection under the unavoidably unsafe doctrine. This certified question case clarified the boundaries of strict products liability for medical devices in Utah.
Background and Facts
Dale Burningham received hip implants in both hips, manufactured by Wright Medical. When parts of the implants failed and required revision surgeries, the Burninghams sued in federal court alleging strict liability design defects. Wright Medical moved to dismiss, arguing that Utah’s unavoidably unsafe doctrine should categorically immunize all implanted medical devices from design defect claims, similar to prescription drugs under Grundberg v. Upjohn Co.
Key Legal Issues
The federal court certified four questions focusing on whether the unavoidably unsafe exception from Restatement (Second) of Torts § 402A comment k applies to implanted medical devices, and if so, whether categorically or case-by-case. The court also questioned whether the type of FDA approval process—premarket approval (PMA) versus 510(k) clearance—affects this analysis.
Court’s Analysis and Holding
The court declined to extend Grundberg’s categorical protection to medical devices cleared through the 510(k) process. Unlike prescription drugs that undergo rigorous FDA review for safety and efficacy, 510(k)-cleared devices only require proof of “substantial equivalence” to existing devices without safety evaluation. The court noted that PMA-approved devices are already immune from state tort claims under federal preemption principles from Riegel v. Medtronic.
For 510(k)-cleared devices, the court held that unavoidably unsafe must be raised as an affirmative defense determined case-by-case. The defendant must prove by a preponderance that: (1) the device could not be made safe for its intended use applying the best available testing and research, and (2) the benefits justified the risks.
Practice Implications
This decision significantly impacts medical device litigation strategy in Utah. Defendants cannot rely on categorical immunity for 510(k)-cleared devices and must prepare fact-specific evidence supporting the unavoidably unsafe defense. Plaintiffs should focus on distinguishing their cases from true unavoidably unsafe scenarios and consider pursuing manufacturing defect or inadequate warning claims, which can defeat the unavoidably unsafe defense even if established.
Case Details
Case Name
Burningham v. Wright Medical
Citation
2019 UT 56
Court
Utah Supreme Court
Case Number
No. 20180143
Date Decided
September 5, 2019
Outcome
Not applicable – certified questions answered
Holding
The unavoidably unsafe exception to strict products liability applies to 510(k)-cleared implanted medical devices as an affirmative defense to be determined case-by-case, not categorically as a matter of law.
Standard of Review
Certified questions from federal district court do not present traditional standards of review
Practice Tip
When defending medical device design defect cases involving 510(k)-cleared devices, raise unavoidably unsafe as an affirmative defense with evidence that the device could not be made safer and its benefits justify its risks.
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