Dietary supplement recommendation as unlawful practice of medicine

Recommending dietary supplements to a patient can, in some states, cross the line into unlawful practice of medicine.

The unlawful practice of medicine issue can affect licensed health care providers such as chiropractors and massage therapists, as well as unlicensed (or non-licensed) practitioners of complementary therapies. (See discussion in Complementary and Alternative Medicine: Legal Boundaries and Regulatory Perspectives).

I came across this interesting case below which involved a non-licensed practitioner assessing someone's health -- that someone turned out to be an undercover investigator -- and recommending dietary supplements. Here is the short version of the case:

Defendant examined and diagnosed the investigator. He poked the agent in the stomach with a pencil and simultaneously pushed down on the agent's outstretched arms. He shined a light in the investigator's eyes and electrically shocked his stomach. Using an [***10] instrument that looked and operated exactly like a ball point pen, defendant stung the agent's hand. From those tests, defendant concluded that the investigator had a clogged colon, weak kidneys, and aluminum in his body. Defendant warned the investigator that those conditions could lead to rectal cancer, and he advised him to schedule another visit. Defendant charged the investigator $ 300 for this visit.

During the follow-up visit, defendant advised the investigator that he needed to watch his diet if he hoped to unclog his colon and stop the rectal bleeding. Specifically, defendant recommended that the agent stop ingesting toxins and take certain vitamins and dietary supplements. The investigator purchased three of the $ 265 worth of recommended dietary products: "Temple Inner Cleanser," "Swedish Elixir," and "Agape Formula # 1."

Curiously, "The Attorney General sought and obtained in the civil action an injunction against defendant, pursuant to N.J.S.A. 45:1-25, whereby defendant was permitted to continue operating the Wellness Center so long as he abided by certain restrictions and not practice medicine."

Many courts do not draw a distinction between dietary supplements and "drugs," and between recommending and "prescribing." This court noted that the "defendant did not issue him a prescription; rather, defendant recommended he purchase several over-the-counter items;" nonetheless, "even suggesting taking vitamins and dietary supplements can, in certain circumstances, constitute the practice of medicine."

Further, the fact that the defendant held a "degree in religion, he has also received a Doctor of Divinity degree and a Doctor of Theology degree" did not help. Nor did the informed consent form help:

The investigator signed an authorization form regarding "The Status Of Dr. Eric Womack, N.D." That form noted that defendant was a "naturopath" whose teachings were not "for the purpose of Diagnosing, mitigating, treating or caring for disease." Indeed, the form stated that diagnosis "of any kind for any disease" is not covered by defendant's practice. The agent was advised that he was "not to act on [Womack's] advice" until he was examined by a licensed medical doctor. Moreover, the forms stated that the service provided "is not a substitute for medical treatment" and is "not yet approved [***23] by the medical profession." The investigator agreed to "always seek medical advise [sic] for medical treatment."

Such a consent form would be highly relevant in a civil action by the patient, but not to a criminal action as here for the unlicensed practice of medicine. On this point, the court stated:

The fact that defendant may have informed the investigator through the authorization forms that he was not a medical doctor does not refute any element of the offense of engaging in the practice of medicine. If defendant was engaging in the practice of medicine, the fact that he may have told the investigator that he was not a medical doctor is simply immaterial.

The court did ultimately allow the informed consent in as potential exculpatory evidence on one ground:

That evidence, however, is highly probative on the alternative basis of the charge--holding oneself out as a medical doctor. The evidence that defendant disclosed his professional status as a doctor of naturopathy and not a medical doctor flatly contradicts the principal [***26] element of that charge. Furthermore, the evidence, which was clearly known to the principal investigating agent, is properly considered to be within the knowledge of the prosecutor. See Kyles v. Whitley, 514 U.S. 436-37, 115 S. Ct. 1555, 1567-68, 131 L. Ed. 2d 490, 508-09 (1995) (imputing knowledge to prosecutor of Brady material known by police officer); State v. Landano, 271 N.J. Super. 1, 37, 637 A.2d 1270 (App.Div.), certif. denied, 137 N.J. 164, 644 A.2d 612 (1994); State v. Engel, 249 N.J. Super. 336, 396, 592 A.2d 572 (App.Div.), certif. denied, 130 N.J. 393 (1991). Because the evidence was clearly exculpatory, highly reliable, and known by the prosecutor, that evidence should have been submitted to the grand jury. The failure to do so requires dismissal of that portion of the indictment.

At least on the charge of holding one's self out as a medical doctor, the consent was relevant. But the consent would not be relevant to the charge of practicing medicine without a license. Procedurally, the end result was that "the portion of the indictment charging defendant with holding himself out as a medical doctor is dismissed without prejudice because of the State's failure to present clearly exculpatory evidence to the grand jury." There are some other complications with double jeopardy that do not concern the above points.

The case is: STATE OF NEW JERSEY, PLAINTIFF-RESPONDENT AND CROSS-APPELLANT, v. ERIC WOMACK, DEFENDANT-APPELLANT AND CROSS-RESPONDENT, A-89/146 September Term 1995, SUPREME COURT OF NEW JERSEY, 145 N.J. 576; 679 A.2d 606; 1996 N.J. LEXIS 961 (1996).SUBSEQUENT HISTORY: Certiorari Denied December 2, 1996, Reported at: 519 U.S. 1011, 117 S. Ct. 517, 136 L. Ed. 2d 405, 1996 U.S. LEXIS 7227.

The moral of the story: when recommending dietary supplements, beware of prohibitions against the unlicensed practice of medicine which may be applicable to licensed complementary and alternative medicine providers who exceed their scope of practice, as well as non-licensed CAM providers. An informed consent form may not necessarily preclude the state from pursuing charges, although it may be relevant to a charge of holding one's self out as a licensed medical doctor. This case would be particularly relevant to unlicensed homeopaths and lay naturopaths as well as energy healers.

Law Offices of Michael H. Cohen offers general corporate legal services, litigation consultation, and expertise in health law with a unique focus on alternative, complementary, and integrative medical therapies.

Michael H. Cohen is Principal in Law Offices of Michael H. Cohen and also President of the Institute for Integrative and Energy Medicine (also known as the Institute for Health, Ethics, Law, Policy & Society), a forum for exploration of legal, regulatory, ethical, and health policy issues involved in the judicious integration of complementary and alternative medical therapies (such as acupuncture and traditional oriental medicine, chiropractic, massage therapy, herbal medicine) and conventional clinical care. The most recent published book by Michael H. Cohen on health care law, regulation, ethics and policy pertaining to complementary, alternative and integrative medicine and related fields is Healing at the Borderland of Medicine and Religion. This is the fourth book in a series, following Complementary and Alternative Medicine: Legal Boundaries and Regulatory Perspectives (1998), Beyond Complementary Medicine: Legal and Ethical Perspectives on Health Care and Human Evolution (2000), and Future Medicine: Ethical Dilemmas, Regulatory Challenges, and Therapeutic Pathways to Health Care and Healing in Human Transformation (2003).

Health care and corporate lawyer Michael H. Cohen has also been admitted to the Bar of England and Wales as a Solicitor (non-practicing), adding to Bar membership in four U.S. states.