Malpractice without a Baseline: Tort Liability and the Structural Paradoxes of Psychedelic-assisted Therapy

Psychedelic-assisted therapy is moving toward clinical legitimacy in the United States, with the FDA granting Breakthrough Therapy designations to psilocybin and MDMA and major research investments underway. However, the legal framework for malpractice liability in this field remains undeveloped. The article identifies three structural challenges: the standard of care is unclear because the profession lacks settled credentialing and practice standards; causation analysis is complicated when treatment intentionally alters a patient's evaluative framework; and damages calculations face a paradox when identity transformation may later be viewed as beneficial. The article argues these are permanent structural features, not transitional problems, and proposes doctrinal adaptations such as prospective consent architectures and tiered standard-of-care frameworks.

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Abstract

Psychedelic-assisted therapy is advancing rapidly toward clinical legitimacy in the United States. The Food and Drug Administration has granted Breakthrough Therapy designations to psilocybin and MDMA, several states have established regulated access frameworks, and major research institutions have invested hundreds of millions of dollars in psychedelic science. Yet the legal infrastructure governing malpractice liability for this emerging treatment modality remains almost entirely undeveloped. This Article identifies three structural challenges that psychedelicassisted therapy poses for traditional malpractice doctrine. First, the standard-of-care inquiry confronts an emerging profession that lacks settled credentialing, licensing norms, and practice standards, making expert testimony unreliable and the custom-based standard largely indeterminate. Second, causation analysis breaks down when the treatment intentionally alters the patient's evaluative framework-the cognitive architecture through which the patient assesses whether an outcome constitutes harm. Third, the damages calculus faces a paradox when the alleged injury is identity transformation that the patient may, after the shift, regard as beneficial. This Article argues that these are not transitional problems that will resolve as the field matures; they are structural features of a therapy that deliberately modifies the baseline against which malpractice doctrine measures deviation, causation, and harm. The Article proposes doctrinal adaptations-including prospective consent architectures, tiered standard-of-care frameworks, and temporal damages models-that would allow tort law to govern psychedelic therapy without collapsing the doctrinal coherence that makes malpractice liability meaningful.