When the Standard of Care Runs Out of Road

American medicine has built its disciplinary and malpractice systems around a single, deceptively simple idea: the standard of care. Yet the standard of care is among the most misunderstood concepts in both medicine and law. It is not written into any statute, not fixed by the Food and Drug Administration (FDA), and not set by the policy statements of professional associations. It is, instead, a legal construct — what a reasonably prudent physician would do under similar circumstances, established case by case through expert testimony.

This essay argues that, properly understood, the standard of care leaves room for — and in some circumstances may favor — the use of lawful but non-traditional interventions, and that in cases of suicidality the doctrine of informed consent should carry weight approaching that of the standard of care itself. The argument proceeds through the law’s own treatment of vagueness, off-label prescribing, professional guidelines, and a little-known provision of California law.

The Standard of Care Is Not Defined by Statute

Because the standard of care is not codified, it might appear too indefinite to support liability. Courts have rejected that objection. In United States v. Collier, 478 F.2d 268 (5th Cir. 1973), a physician prosecuted under the Controlled Substances Act for dispensing methadone outside “the usual course of professional practice” argued that the governing standard was unconstitutionally vague. The Fifth Circuit disagreed, reasoning that the statute requires only the kind of professional judgment a physician is called upon to make routinely — whether a drug is dispensed for a legitimate medical purpose in the bona fide treatment of a patient — and that this professional-practice standard is definite enough to satisfy due process. The standard is flexible and context-dependent, but it is not vague: it is anchored in what competent practitioners actually do, and it is proven through expert testimony.

The Federation of State Medical Boards has expressed the same conviction from the regulator’s side, advising that where the standard of care is unclear, boards should “use all medical and scientific resources at their disposal to establish a standard, rather than succumb to pressure from vocal individuals or special interest groups,” because there is “a true standard of care that can be identified in all instances — through appeal to appropriate evidence and expertise.”

The Gap in the Care of Suicidal Patients

Suicidality is a paradigm case of a condition for which the standard of care is, in the Federation’s words, “unclear or difficult to identify.” Beyond the conventional pharmacology of SSRIs, SNRIs, and other antidepressants, and the established psychotherapies — cognitive behavioral therapy, dialectical behavior therapy, and talk therapy — medicine offers the physician remarkably little concrete guidance on how to keep a person who intends to end their life from doing so. The maxim primum non nocere, “first, do no harm” (associated with the Hippocratic tradition though not, in fact, a line of the Oath), states an ethical floor but not a course of treatment. When the conventional options have been exhausted and the patient remains at acute risk, the standard of care can become an absence rather than a guide. It is precisely in that absence that emerging interventions become relevant.

The Evidence for Non-Traditional Interventions

A growing body of controlled research suggests that several compounds long classified primarily as drugs of abuse have therapeutic value in trauma, depression, and suicidality. A phase 3 randomized, double-blind, placebo-controlled trial of MDMA-assisted therapy for severe post-traumatic stress disorder found that 67 percent of participants no longer met diagnostic criteria for PTSD after treatment, compared with 32 percent in the placebo group (Mitchell et al., Nature Medicine, 2021). A double-blind trial of single-dose psilocybin for treatment-resistant depression found that a 25-milligram dose produced significantly greater reductions in depression scores at three weeks than a control dose (Goodwin et al., New England Journal of Medicine, 2022). Ketamine, already approved and in routine clinical use, has repeatedly been shown to reduce suicidal ideation rapidly, often within hours.

The evidence should be characterized honestly. Ketamine’s effect on suicidal ideation is well documented, but the data on whether it reduces suicide attempts over longer horizons are mixed, with at least one randomized trial finding no advantage over placebo on that endpoint. This nuance does not weaken the argument; it sharpens it. The law does not ask whether an intervention is guaranteed to work, but whether a reasonably prudent physician, weighing risks and benefits with the patient, could choose it. Of these compounds, only ketamine is presently lawful to administer — as a Schedule III controlled substance — and its use for depression remains formally off-label.

Off-Label Use Is Within the Standard of Care

The off-label designation does not, by itself, signal a departure from the standard of care. Off-label prescribing is a routine and often essential part of modern practice. Gabapentin, approved for epilepsy, is widely used for neuropathic pain, fibromyalgia, bipolar disorder, and migraine. Minoxidil, approved for hypertension, became familiar as Rogaine after its hair-growth effect was observed and separately approved.

Courts have been explicit that FDA action does not set the standard of care. In Richardson v. Miller, 44 S.W.3d 1 (Tenn. Ct. App. 2000), the court held that a drug’s labeling and Physicians’ Desk Reference entry are not intended by the manufacturer or the FDA to establish the standard of care, and that the absence of FDA approval for a particular use does not imply that the use is improper. The Ohio Court of Appeals put the point directly in Klein v. Biscup, 109 Ohio App.3d 855 (1996): “the FDA does not regulate the practice of medicine, and therefore the decision whether or not to use a drug for an off-label purpose is a matter of medical judgment, not of regulatory approval.” A physician’s off-label decision is judged by whether it accords with the practice of a reasonably prudent physician — not by the label.

Professional Guidelines, and Ethics, Are Not the Law

If FDA labeling does not fix the standard of care, neither do the policies of professional associations. The guidelines of bodies such as the American Medical Association (AMA) and the American Psychiatric Association (APA) are evidence a factfinder may weigh; they are not themselves the legal standard. California courts have drawn the line sharply between professional ethics and law. In Thorburn v. Department of Corrections, 66 Cal. App. 4th 1284 (1998), physicians argued that participation in executions was “unprofessional conduct” under the Medical Practice Act because the AMA, the California Medical Association, and other organizations had declared it unethical. The Court of Appeal rejected the argument as a matter of law: the breach of a profession’s ethical code is not, in itself, a violation of law. Ethical pronouncements, however weighty, do not carry the force of statute.

That distinction matters because professional bodies have not always been right, and have often lagged practice. In the 1930s the AMA maintained policies that effectively excluded Black physicians, reinforcing the segregation of the profession. More recently, professional ethics and state law have openly diverged. The California End of Life Option Act, signed by Governor Jerry Brown in October 2015 and effective in June 2016, made California the fifth state to permit physicians to prescribe life-ending medication to terminally ill patients. The AMA’s then-prevailing Opinion 2.211 declared physician-assisted suicide “fundamentally incompatible with the physician’s role as healer.” A state trial court invalidated the Act on procedural grounds in May 2018; an appellate court reinstated it the following month, and the California Supreme Court declined to review the challenge, leaving the law in force. The episode illustrates a recurring pattern: the AMA, like the FDA, is frequently years behind the state of practice, and therefore behind the standard of care.

A Statutory Pathway: Business & Professions Code § 2234.1

California law anticipates this lag directly. Business and Professions Code § 2234.1, which addresses the circumstances in which a physician shall not be disciplined for alternative or complementary treatment, opens with a striking acknowledgment: “Since the National Institute of Medicine has reported that it can take up to 17 years for a new best practice to reach the average physician or surgeon, it is prudent to give attention to new developments — particularly those that are not yet broadly recognized in California.” The section provides that a physician “shall not be subject to discipline — solely on the basis that the treatment or advice — is alternative or complementary medicine,” provided certain conditions are met, including that the treatment “is provided after informed consent and a good-faith prior examination of the patient, and medical indication exists for the treatment or advice, or it is provided for health and well-being.”

The statute defines alternative or complementary medicine as methods “not generally used but that provide a reasonable potential for therapeutic gain in a patient’s medical condition that is not outweighed by the risk of the health care method.” That definition is, in effect, a risk-benefit test, and it maps cleanly onto the use of a lawful, well-characterized agent such as ketamine in a patient at risk of suicide. Section 2234.1 thus offers a common-sense path: a physician acting in good faith should weigh all potentially therapeutic remedies, and in suicidality the risk of the remedy must be measured against the risk of withholding it.

Weighing Risk Scientifically

Risk, in the medical context, must be assessed scientifically rather than through prevailing narrative. Ketamine has a long clinical track record and a strong safety profile when properly dosed. Like any drug — including over-the-counter agents such as acetaminophen — it can be dangerous at sufficiently high doses; the standard of care is to balance the benefit of a correct dose against the remote risk of misuse, not to forbid the drug because misuse is conceivable. Considerations of access belong in the same calculus. Millions of patients safely use prescribed controlled substances, including stimulants, at home. To declare categorically that a drug such as ketamine is inappropriate for any at-home use may itself endanger patients who cannot afford repeated in-office administration but who would benefit from treatment. “Set and setting” are legitimate clinical concerns, but they should be calibrated to evidence and to the individual patient, not to assumptions about what is socially appropriate.

Informed Consent as the Decisive Standard

This brings the argument to its center. As genuinely promising therapies emerge, courts will repeatedly confront situations in which professional bodies, the FDA, and even the broad medical community have not yet caught up to the state of the art. In those situations, the physician who possesses advanced knowledge of an intervention’s therapeutic potential — particularly a lawful intervention — should not withhold potentially life-saving treatment out of fear of administrative or judicial reprisal. The appropriate safeguard is the oldest one in medicine: informed consent. When a patient has been told the risks and benefits of an intervention and chooses to pursue it, that choice deserves legal respect, even where the intervention is not yet widely accepted.

Nowhere is this more compelling than in suicidality, where the patient, guided by a physician, may effectively be choosing whether to live. Informed consent offers an escape from a paternalism that would let a patient die rather than try an intervention that a medical board’s experts do not yet understand. It is not a loophole; it is the foundation of modern medical ethics — transparency, shared decision-making, and respect for autonomy — and in the narrow, urgent context of suicidality it may be the only ethical course once conventional treatment has failed.

Criminal Liability, Administrative Risk, and Conclusion

The Supreme Court has recently strengthened the physician’s position on the criminal side. In Ruan v. United States, 142 S. Ct. 2370 (2022), the Court held that once a defendant authorized to dispense controlled substances produces evidence of that authorization, the Government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner. A physician cannot be convicted merely because a treatment was unconventional; the state must prove a culpable mental state.

Ruan, however, governs criminal prosecution, not administrative discipline — and it is administrative action, not indictment, that most physicians realistically fear. Medical boards may still pursue practitioners who use ketamine, or other non-traditional interventions, on the basis of outdated guidance rather than evidence. The thesis of this essay is that they should not. Courts and boards alike should give informed consent weight approaching that of the standard of care when reviewing the care of suicidal patients. In that setting the standard of care is not a list of approved options; it is the obligation to do what may save the patient’s life, provided the patient understands and accepts the risks and benefits of the attempt.

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Sources

United States v. Collier, 478 F.2d 268 (5th Cir. 1973) · Richardson v. Miller, 44 S.W.3d 1 (Tenn. Ct. App. 2000) · Klein v. Biscup, 109 Ohio App.3d 855, 673 N.E.2d 225 (1996) · Thorburn v. Department of Corrections, 66 Cal. App. 4th 1284 (1998) · Ruan v. United States, 142 S. Ct. 2370 (2022) · Cal. Bus. & Prof. Code § 2234.1 · California End of Life Option Act, Cal. Health & Safety Code §§ 443 et seq. · AMA, Code of Medical Ethics, Opinion 2.211 · Mitchell et al., Nature Medicine 27 (2021): 1025–1033 · Goodwin et al., New England Journal of Medicine 387 (2022): 1637–1648.