Opinion ID: 1495900
Heading Depth: 2
Heading Rank: 2

Heading: Complaints Against Dr. McDonagh.

Text: In 1994, seven years prior to the adoption of 4 CSR 150-2.165, and shortly after the two noted controlled studies, the Board filed a complaint against Dr. McDonagh arising out of two inquiries regarding his use of chelation therapy. This complaint was later dismissed without prejudice. In 1996, the Board filed a thirteen-count complaint alleging cause to discipline Dr. McDonagh's medical license for violating section 334.100 [7] by, among other things: endangering the health of patients through the inappropriate provision of chelation therapy; misrepresenting the efficacy of this therapy for atherosclerosis and other diseases; conducting unnecessary testing and treatment in some instances, and insufficient testing and treatment in others; and failing to maintain adequate medical records. [8] Dr. McDonagh denied that his treatments endangered his patients, denied using inappropriate testing or treatment, and denied inadequate record keeping. He also denied making misrepresentations to patients, noting that, prior to receiving chelation therapy, his patients signed a consent form explaining the possible benefits and side effects of the treatment (very similar to that later approved in 4 CSR 150-2.165), and stating that the treatment was not approved by the FDA, the AMA, or other recognized medical organizations for the treatment of vascular disease. In addition to chelation therapy, Dr. McDonagh encouraged patients to follow a diet and exercise plan, and did not discourage patients from seeing other physicians, including specialists. The AHC held a hearing in November 1997. The Board introduced expert testimony that the use of chelation therapy to treat vascular disease is not generally accepted in the field of treatment of vascular disease and does not meet the standard of care for treatment of vascular disease. Dr. McDonagh offered expert testimony that supported his off-label use of chelation therapy to treat vascular disease. The Board objected. The AHC heard all of the evidence without ruling on its admissibility, as permitted by section 536.070(7), which provides that evidence subject to an objection nevertheless be heard and preserved in the record. The AHC ultimately ruled that the testimony was admissible, found no evidence of harm from chelation therapy, rejected all thirteen counts, and found no cause to discipline Dr. McDonagh's medical license. The circuit court affirmed the AHC's decision. The Board appealed. Following opinion by the Missouri Court of Appeals, Western District, this Court granted transfer to address the standards for admission of expert testimony in civil and administrative cases. Mo. Const. art. V, secs. 10, 18.