Off-Label Neuroimaging

The growth of neuroimaging evidence in the courtroom is consistent with the increased reliance on technical and machine-based specialties at trial. Litigants routinely seek to introduce neuroimaging evidence in both civil and criminal trials to supplement traditional medical, psychiatric, and psychological opinion testimony. A substantial portion of neuroimaging evidence is still in the developmental stage—what I term “off-label neuroimaging.” Unsurprisingly, evaluating the reliability of developing neuroimaging poses challenging questions for gatekeeping courts. Among the complex evidentiary issues neuroimaging presents for courts and litigants, this Article considers one foundational question: How should courts determine whether neuroimaging evidence is sufficiently reliable for trial? To help courts evaluate the reliability requirements for developing neuroimaging evidence, this Article examines what I term “off-label neuroimaging” in two ways: (1) medical neuroimaging not yet clinically adopted; and (2) neuroimaging for which there is no proof of ecological validity, or “real world” use. This Article explains the shortcomings of off-label neuroimaging and proposes a framework to guide the courts, providing an explanation of why simply applying the Daubert factors is often insufficient to manage the problems the evidence poses. For medical neuroimaging used diagnostically, the proposed framework suggests that courts give greater weight to the consensus position of medical practice in determining whether evidence is both foundationally reliable and reliable as applied. Additionally, for non-medical (such as fMRI lie detection), the Article urges courts to apply the ecological validity test that considers whether the evidence has been tested in the “real world.”