On September 4, 2019, the Utah Supreme Court ruled that the unavoidably unsafe exception to strict products liability in design defect claims recognized in Comment k to Section 402A of the Restatement (Second) of Torts applies to implanted medical devices on a case-by-case basis, rather than as a categorical bar to strict liability. The court held that the 510(k) clearance process is not sufficiently rigorous or focused on safety to justify a categorical bar to strict liability for all 510(k) cleared devices. This ruling was a setback for WLF, which argued that all implantable medical devices are “unavoidably unsafe” and thus not subject to strict products-liability suits alleging that they were defectively designed. Utah state law, which recognizes Section 402A of the Restatement (Second) of Torts, applies that legal designation from Restatement Comment k to prescription drugs. WLF’s brief argued that, like drugs, implantable medical devices can impact different patients in different ways, and yet, the potential life-saving and life-altering benefits outweigh the attendant risks.
