State Bd. of Reg. Healing Arts v. Mcdonagh

• Decision Date: 23 December 2003
• Docket Number: No. SC 85275.,SC 85275.
• Parties: STATE BOARD OF REGISTRATION FOR THE HEALING ARTS, Appellant, v. Edward W. McDONAGH, D.O., Respondent.
• Court: Missouri Supreme Court

123 S.W.3d 146

STATE BOARD OF REGISTRATION FOR THE HEALING ARTS, Appellant, v. Edward W. McDONAGH, D.O., Respondent.

No. SC 85275.

Supreme Court of Missouri, En Banc.

December 23, 2003.

Rehearing Denied January 27, 2004.

Glenn E. Bradford, Edward F. Walsh, IV, Kansas City, MO, for Appellant.

Lori J. Levine, R. Max Humphreys, Daniel P. Card, II, Jefferson City, MO, for Respondent.

Mark G. Arnold, St. Louis, MO, for Amicus Cyriae Missouri State Medical Association, Missouri Association of Osteopathic Physicians and Surgeons.

LAURA DENVIR STITH, Judge.

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 334.100,¹ 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. 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.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 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, 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. McDonagh, 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:

(1) Pursuant to authority granted to the board by section 334.100.2(4)(f), RSMo, the board declares the use of ethylinediaminetetracetic 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 chelation 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. McDonagh.

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 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.

II. STANDARD OF REVIEW

On appeal, this Court reviews the AHC's decision, rather than that of the trial court, to determine whether the agency action:

(1) Is in violation of constitutional provisions;

(2) Is in excess of the statutory authority or jurisdiction of the agency;

(3) Is unsupported by competent and substantial evidence upon the whole record;

(4) Is, for any other reason, unauthorized by law;

(5) Is made upon unlawful procedure or without a fair trial;

(6) Is arbitrary, capricious or...