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State Board of Registration for the Healing Arts v. McDonagh12/23/2003
The State Board of Registration for the Healing Arts (the Board) initiated a disciplinary complaint against Dr. Edward McDonagh primarily alleging that he violated section 334.100, a part of the Missouri Healing Arts Practice Act, through his representations regarding and use of chelation therapy in the treatment of patients with vascular disease. The Administrative Hearing Commission (AHC) found no cause to discipline Dr. McDonagh's medical license. The circuit court affirmed the AHC's decision. The Board appeals, alleging the AHC erred by failing to apply the standard for admission of expert testimony set out in Frye v. United States, 293 F. 1013 (D.C. Cir. 1923), and that the testimony of Dr. McDonagh's experts should have been excluded.
This Court reaffirms its holding in Lasky v. Union Electric Co., 936 S.W.2d 797 (Mo. banc 1997), that the standard for the admission of expert testimony in civil cases is that set forth in section 490.065. As discussed herein, this is also the standard to be applied in administrative cases. To the extent that civil cases decided since Lasky apply Frye or some other standard, they are incorrect and should no longer be followed. Section 490.065.3 requires that the facts and data on which an expert relies must be those reasonably relied on by experts in the relevant field. Here, the relevant field is physicians treating persons with vascular disease. Because the AHC failed to properly apply this standard, this Court reverses the circuit court's judgment and remands the case. On remand, the circuit court should remand to the AHC for reconsideration of the AHC's decision in light of this standard.
This Court also remands for reconsideration of the issue whether Dr. McDonagh committed repeated negligence because his experts did not identify the standard of care by which they judged his treatment of his patients and it appears the AHC judged his conduct by reference to the treatment advocated by other doctors using chelation therapy. Under section 334.100.2(5), the AHC should have judged the conduct by the standard of care of those treating patients with vascular disease.
Because the principles stated herein may also affect the AHC's determination of the remaining issues regarding record keeping, testing, and misrepresentation, this Court remands the case in its entirety for reconsideration in light of this opinion.
I. FACTUAL AND PROCEDURAL BACKGROUND
The Board is authorized by section 334.120.1 to register, license, and supervise physicians and surgeons practicing in Missouri. The Board licensed Dr. McDonagh, D.O., as an osteopathic physician and surgeon in 1961. Soon after becoming licensed, he began employing alternative medical treatments in his family practice, including EDTA chelation therapy to treat atherosclerosis and other diseases. He also became certified by the American Board of Chelation Therapy, and has conducted research and written extensively on the use of this therapy.
A. Regulation of Chelation Therapy by the Board.
Chelation therapy has been approved by the federal Food and Drug Administration (FDA) only as a means for the removal of heavy metals from the body. However, non-FDA-approved, or "off-label," use of medications by physicians is not prohibited by the FDA and is generally accepted in the medical profession. See 21 U.S.C. Sec. 396 (2000); Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 350-51 & n.5 (2001). Approximately 1,000 physicians in the United States engage in the off-label use of chelation therapy to treat atherosclerosis and other vascular conditions. Of these 1,000 United States-based physicians, 750 belong to the American College fo
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