State Board of Registration for the Healing Arts v. McDonagh

123 S.W.3d 146, 2003 Mo. LEXIS 173, 2003 WL 22999293
CourtSupreme Court of Missouri
DecidedDecember 23, 2003
DocketSC 85275
StatusPublished
Cited by97 cases

This text of 123 S.W.3d 146 (State Board of Registration for the Healing Arts v. McDonagh) is published on Counsel Stack Legal Research, covering Supreme Court of Missouri primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
State Board of Registration for the Healing Arts v. McDonagh, 123 S.W.3d 146, 2003 Mo. LEXIS 173, 2003 WL 22999293 (Mo. 2003).

Opinions

LAURA DENVIR STITH, Judge.

The State Board of Registration for the Healing Arts (the Board) initiated a disciplinary complaint against Dr. Edward MeDonagh primarily alleging that he vio[149]*149lated section 334.100,1 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. McDo-nagh’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.2

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 EDTA3 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 [150]*150heavy 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, 121 S.Ct. 1012, 148 L.Ed.2d 854 (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.4 Of these 1,000 United States-based physicians, 750 belong to the American College for Advancement in Medicine (ACAM), which has 1,000 members worldwide and which endorsed chelation therapy as a valid course of treatment for occlusive vascular and degenerative diseases associated with aging.5 To that end, ACAM developed a protocol, followed by Dr. McDo-nagh, for using chelation therapy to treat such diseases.

In 1989, the Board made an in-depth study of the efficacy of chelation therapy, but did not thereafter adopt any rules, regulations, or position papers on the use of this therapy. Then, in 1992 and 1994, two controlled studies were published that suggested that chelation therapy was ineffective in treating vascular disease.6 Dr. McDonagh disputes the validity of these studies. But, after the publication of the studies, the American Medical Association (AMA) adopted a position statement on chelation therapy, declaring that: “(1) [t]here is no scientific documentation that the use of chelation therapy is effective in the treatment of cardiovascular disease, atherosclerosis, rheumatoid arthritis, and cancer”; (2) chelation therapy proponents should conduct controlled studies and adhere to FDA research guidelines if they want the therapy to be accepted more broadly; and (3) “[t]he AMA believes that chelation therapy for atherosclerosis is an experimental process without proven efficacy.” AMA, AMA Policy Compendium H-175.994, H-175.997 (1994).

In spite of these developments, neither the FDA, the AMA, or the Board banned the use of chelation therapy to treat vascular disease, and Dr. McDonagh continued to prescribe and administer the therapy in his practice.

Effective October 30, 2001, the Board adopted, a rule stating that chelation therapy was of no medical value but that it would not seek to discipline a physician for using it on a patient from whom appropriate informed consent is received:

[151]*151(1) Pursuant to authority granted to the board by section 334.100.2(4)(f), RSMo, the board declares the use of ethyline-diaminetetracetic acid (EDTA) chelation on a patient is of no medical or osteopathic value except for those uses approved by the Food and Drug Administration (FDA) by federal regulation.
(2) The board shall not seek disciplinary action against a licensee based solely upon a non-approved use of EDTA che-lation if the licensee has the patient sign the Informed Consent for EDTA Chelation Therapy form, included herein, before beginning the non-approved use of EDTA chelation on a patient.

4 CSR 150-2.165.

B. Complaints Against Dr. McDo-nagh.

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 334.1007

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Bluebook (online)
123 S.W.3d 146, 2003 Mo. LEXIS 173, 2003 WL 22999293, Counsel Stack Legal Research, https://law.counselstack.com/opinion/state-board-of-registration-for-the-healing-arts-v-mcdonagh-mo-2003.