State Board of Registration for the Healing Arts v. McDonagh

Dr. McDonagh (defendant) was licensed in Missouri as an osteopathic physician and surgeon who used alternative medical treatments in his practice, including ethylene diamine tetra-acetic acid (EDTA) chelation therapy to treat atherosclerosis and other conditions. The U.S. Food and Drug Administration (FDA) had only approved chelation therapy to be used to remove heavy metals from within the body. However, the FDA did not prohibit the use of medications to treat conditions that the drugs were not specifically designed for. This “off-label” use of therapies and medications was common practice in the medical profession, including the off-label use of chelation therapy to treat atherosclerosis and other vascular conditions. Two published studies concluded that the treatment was ineffective in treating vascular disease. The American Medical Association relied upon the studies when it issued a position statement calling the EDTA chelation therapy experimental without proven efficacy. The State Board of Registration for the Healing Arts (the Board) (plaintiff) subsequently adopted a rule stating that EDTA chelation therapy was of no medical value except for uses specifically approved by the FDA. McDonagh continued to use the EDTA chelation therapy pursuant to the ACAM protocol and had patients sign informed consent documents. Thereafter, the Board filed a 13-count complaint against McDonagh after receiving a number of inquiries regarding his use of the therapy and claimed that he had endangered his patients. The Administrative Hearing Commission (AHC) held a hearing on the matter and found no evidence of harm from the chelation therapy and did not discipline McDonagh. The circuit court affirmed the decision of the AHC and the Board appealed.