Opinion
No. WD 60501
March 25, 2003
Appeal from the Circuit Court of Cole County, Missouri, Honorable Byron Kinder, Judge.
Glenn E. Bradford, Esq., — Kansas City, MO, for Appellant.
Lori J. Levine, Esq., — Jefferson City, MO, for Respondent.
Before Ellis, C.J., Holliger and Hardwick, JJ.
This appeal arises from the Administrative Hearing Commission's (Commission) determination that "no cause" existed to discipline the medical license of Edward McDonagh, D.O. The Missouri State Board of Registration for the Healing Arts (Board) had filed a disciplinary Complaint alleging Dr. McDonagh endangered the physical and mental health of his patients through the use of EDTA chelation therapy. On appeal, the Board challenges the denial of the Complaint, asserting the Commission erroneously applied the law in admitting and relying on expert testimony, failed to make required findings of fact, and arbitrarily rejected claims supported by the evidence. We reverse and remand.
Factual and Procedural Background
The State Board of Registration for the Healing Arts is an agency established under Missouri law to register, license, and supervise physicians. § 334.120. In 1961, the Board licensed Dr. Edward McDonagh to practice medicine as an osteopathic physician and surgeon. Within one year of beginning his practice in family medicine, Dr. McDonagh became interested in EDTA chelation therapy as a preventive approach to treating advanced, chronic diseases in elderly patients.
EDTA (ethylene diamine tetra-acetic acid) is a drug approved by the Federal Food and Drug Administration for the sole purpose of removing heavy metals (such as iron, mercury, and lead) from the human body. Since the 1950's, a minority of physicians have treated arteriosclerosis and other vascular diseases with EDTA chelation therapy. This therapy involves the intravenous administration of a diluted solution containing EDTA, magnesium, and other vitamins and minerals as needed. Proponents of chelation therapy contend the EDTA binds with heavy metals that can accumulate in the bloodstream and block arteries. When the EDTA is excreted through urine, the body is also relieved of the heavy metal deposits.
Dr. McDonagh and other proponents believe EDTA chelation therapy prolongs and improves the quality of life for many geriatric patients. During the past thirty-five years, Dr. McDonagh has used chelation therapy as an alternative treatment for vascular disease in geriatric patients and has done extensive research, writing, and teaching on the subject.
During 1989, the Board conducted a review of the efficacy of EDTA chelation therapy. The Board considered a proposed rule declaring such therapy to have no medical or osteopathic value beyond the uses approved by the FDA. The Board declined to enact the rule due to a lack of scientific evidence that EDTA chelation therapy was not an effective treatment for vascular disease.
Subsequent to that decision, two published studies — the Guldager study in 1992 and the van Rij study in 1994 — prompted the Board to reconsider its view regarding the available scientific evidence. Both studies concluded that EDTA chelation therapy was not an effective treatment for arteriosclerosis. The Board was also aware of the following position statement issued by the American Medical Association (AMA) in 1994 regarding EDTA chelation therapy:
There is no scientific documentation that the use of chelation is effective in the treatment of cardiovascular disease, atherosclerosis, rheumatoid arthritis, and cancer. If chelation is to be considered a useful medical treatment for anything other than heavy metal poisoning, hypercalcemia or digitalis toxicity, it is the responsibility of its proponents to conduct properly controlled scientific studies to adhere to FDA guidelines for drug investigation and to disseminate study results in the ususally accepted channels. The AMA believes that chelation for atherosclerosis is an experimental process without proof in efficacy.
In 1994, the Board filed a disciplinary Complaint against Dr. McDonagh based on reports from two patients complaining about his use of chelation therapy. This original Complaint was dismissed without prejudice.
On December 6, 1996, the Board again filed a Complaint requesting the Administrative Hearing Commission to find cause for disciplinary action against Dr. McDonagh's medical license. The thirteen-count Complaint alleged Dr. McDonagh violated the Missouri Healing Practices Act, § 334.100 et seq. R.S.Mo. 1994, by endangering patients through the use of EDTA chelation therapy, failing to keep adequate medical records, conducting inappropriate and unnecessary testing procedures, and misrepresenting the efficacy of chelation therapy.
Both prior to and during the Commission's hearing on the Complaint, the Board moved to exclude all expert testimony in support of EDTA chelation therapy because, it argued, the scientific evidence was inadmissible under the "general acceptance" test set forth in Frye v. U.S., 293 F. 1013 (D.C. Cir. 1923). The parties stipulated the experts would be allowed to testify at the hearing, subject to the Board's standing Frye objection.
The Commission heard evidence presented by both parties over an eight-day period in November 1997. On January 26, 2000, the Commission determined there was no cause to discipline Dr. McDonagh's medical license. The Commission found the expert testimony in support of chelation therapy was admissible and substantially relied on the scientific evidence in its detailed Findings of Facts and Conclusions of Law, which denied all thirteen counts of the Board's Complaint.
On judicial review, the Circuit Court of Cole County affirmed the Commission's decision. The Board appeals.
Standard of Review
Section 536.140, R.S.Mo. 2000, defines the scope of appellate review. On appeal of this administrative decision, our review is of the Commission's findings and conclusions, not the circuit court's judgment. Hernandez v. State Bd. of Registration for the Healing Arts, 936 S.W.2d 894, 900 (Mo.App.W.D. 1997). We will affirm the Commission's decision unless it is unsupported by competent and substantial evidence upon the whole record or is unauthorized by law. §§ 536.140.2, 536.140.3. "The Commission's decision is presumed valid, and the burden is on the attacking party to overcome that presumption." Hernandez, 936 S.W.2d at 900. The record must be viewed in a light most favorable to the Commission's decision, according great deference to its findings of fact. Dorman v. State Bd. of Registration for the Healing Arts, 62 S.W.3d 446, 454 (Mo.App.W.D. 2001). Questions of law, however, are reserved for the independent judgment of the reviewing court. State Bd. of Registration for the Healing Arts v. Boston, 72 S.W.3d 260, 263 (Mo.App.W.D. 2002).
All subsequent statutory citations are to the Revised Statutes of Missouri 2000, unless otherwise indicated.
Admissibility and Sufficiency of Expert Testimony
In its first point on appeal, the Board contends the Commission erred in admitting into evidence and relying on the testimony of Dr. McDonagh and other medical experts in support of EDTA chelation therapy. The Board argues the testimony was inadmissible because it did not meet the "general acceptance test" for scientific evidence under Frye, 293 F. 1013. Further, the Board argues the testimony should not have been considered because the experts failed to establish that chelation therapy met the "standard of care" required under Missouri law. Absent the erroneous admission and consideration of this testimony, the Board contends there is no competent and substantial evidence to support the Commission's determination that chelation therapy is an effective treatment method.
A. Admissibility of Expert Testimony
In Frye, 293 F. at 1014, the court held that, to be admissible, expert testimony must be based on scientific principles generally accepted in the relevant scientific community . The Frye rule has been adopted in civil and criminal cases in Missouri. State v. Stout, 478 S.W.2d 368, 371 (Mo. 1972); Alsbach v. Bader, 700 S.W.2d 823, 828-30 (Mo.banc 1985). The rule was modified by the Missouri Supreme Court in State v. Biddle, 599 S.W.2d 182, 191 (Mo.banc 1980), which held that "wide scientific approval" of the reliability of the scientific method employed is required for admission of expert testimony.
Dr. McDonagh argues that application of the Frye rule conflicts with section 490.065, which governs the admissibility of expert testimony in civil cases. Similar to the principles set forth in Federal Rules of Evidence 702 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), section 490.065 allows the admission of expert testimony if the scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or determine a fact in issue. The statute requires the testimony to be based on facts or data "reasonably relied upon by experts" in the field, but it does not require that the expert's principles or techniques be widely accepted in the relevant scientific community, as mandated by the modified Frye rule. § 490.065.3.
Section 490.065 provides in relevant part:
1. In any civil action, if scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training or education may testify thereto in the form of an opinion or otherwise.
2. . . .
3. The facts or data in a particular case upon which an expert bases an opinion or inference may be perceived by or made known to him at or before the hearing and must be of a type reasonably relied upon by experts in the field in forming opinions or inferences upon the subject and must be otherwise reasonably reliable.
Since the enactment of the statute in 1989, the Missouri Supreme Court has declined to directly decide whether section 490.065 supercedes application of the Frye rule in the same manner that Daubert changed the admissibility requirements for expert testimony in federal courts. See Callahan v. Cardinal Glennon Hosp., 863 S.W.2d 852, 860 (Mo.banc 1993). In Lasky v. Union Elec., 936 S.W.2d 797, 801 (Mo.banc 1997), the Court gave remand instructions that the trial court was to "be guided by section 490.065 in evaluating the admission of expert testimony." Notably, the Court did not discuss either Frye or Daubert in directing application of the statute.
In Daubert , the U.S. Supreme Court rejected the Frye rule and set forth a new test for admissibility of expert scientific evidence based on its interpretation of Federal Rule of Evidence 702. Daubert requires a trial court to consider whether the expert's scientific knowledge will assist the trier of fact to understand or determine a fact in issue. 509 U.S. at 592. In making this assessment, courts can consider the following factors: (1) the expert's qualifications; (2) whether the theory or technique has been tested; (3) whether the theory has been subjected to peer review and publication; (4) the known or potential rate of error and the existence of standards; and (5) general acceptance within the community. Id. at 593-94.
While "general acceptance" is the primary criteria under Frye, it is only one factor in the Daubert analysis. The court specifically noted in Daubert that consideration of the general acceptance factor is permitted but not required. Id. at 594.
All three districts of the court of appeals have expressed confusion about the applicable standard in the wake of Lasky and the absence of a clear directive that Frye has been overruled. See Long v. Mo. Delta Med. Ctr., 33 S.W.3d 629, 643 (Mo.App.S.D. 2000); M.C. v. Yeargin, 11 S.W.3d 604, 618-19 (Mo.App.E.D. 1999); McReynolds v. Mindrup, No. W.D. 60747, 2002 WL 31162729, *6 n. 2 (Mo.App.W.D. Oct. 1, 2002). There is uncertainty about whether section 490.065 supplants the Frye rule in civil cases and whether an evaluation of expert testimony under section 490.065 requires consideration of Frye or the Daubert factors.
For example, in McReynolds, 2002 WL 31162729 at **3, the Western District used a Frye analysis to determine the admissibility of medical expert testimony under section 490.065. In a prior case, Keyser v. Keyser, 81 S.W.3d 164, 169 (Mo.App.W.D. 2002), we applied section 490.065, without any discussion of Frye or Daubert, to evaluate a physician's expert testimony. See also, Hobbs v. Harken, 969 S.W.2d 318, 322 (Mo.App.W.D. 1998). Taking a different approach in Whitman's Candies, Inc. v. Pet, Inc., 974 S.W.2d 519, 528 (Mo.App.W.D. 1998), we ruled that a consumer psychologist's testimony on lost profits was admissible under both Frye and section 490.065, using a Daubert analysis to interpret the statute. The Eastern District used that same approach to evaluate a medical expert's testimony in Yeargin, 11 S.W.3d at 618-19. Later, in Fierstein v. DePaul Health Center, 24 S.W.3d 220, 226 (Mo.App.E.D. 2000), the Eastern District applied § 490.065 to medical testimony without any discussion of Frye or Daubert. By contrast, the Southern District has held that Frye is applicable to expert testimony based on scientific principles, while section 490.065 governs the admissibility of non-scientific evidence. Long, 33 S.W.3d at 642-43. Thus, in Brooks v. SSM Health Care, 73 S.W.3d 686, 694 (Mo.App.S.D. 2002), the court analyzed expert medical testimony under Frye without any mention of section 490.065.
In McReynold , we applied Frye only because the "trial court based its decision entirely on Frye." 2002 WL 31162729 at **6 n. 2. We further acknowledged that it is unclear "what, if any, impact adoption of section 490.065 has on the application of the Frye `general acceptance' rule." Id.
These decisions illustrate that no consistent standard has been applied to determine the admissibility of scientific evidence in civil cases. Given the multiple approaches outlined by our courts, it is not surprising in this case that the Commission deemed it necessary to analyze the expert testimony in support of EDTA chelation therapy under both the Frye rule and section 490.065 using the Daubert factors. The Commission determined the testimony of the medical experts was admissible under both standards.
On appeal, the Board challenges the admissibility of the evidence only under the Frye rule. Based on the Eastern District's decision in Yeargin, the Board argues that the Frye test is applicable to scientific evidence in Missouri and asserts the expert's testimony in support of chelation therapy failed to meet standards of general acceptability or wide scientific approval. In essence, the Board asserts the Commission's consideration of section 490.065 and Daubert is irrelevant because the evidence was admissible only if it satisfied the Frye test. We disagree that Yeargin supports the Board's position.
In Yeargin, the Eastern District held that the trial court erred in failing to determine whether a physician's testimony was "based on scientific principles generally accepted in the relevant scientific community or within the boundaries of § 490.065." 11 S.W.3d at 619 (emphasis added). The court analyzed section 490.065 consistent with Daubert principles. Id. While noting "[t]he Missouri Supreme Court continues to apply the Frye test to the admissibility of expert testimony in criminal and civil cases." the Yeargin court ultimately considered whether the physician's testimony could satisfy either Frye or section 490.065. The holding in Yeargin actually contradicts the Board's argument that section 490.065 is inapplicable or irrelevant in evaluating evidence based on scientific principles.
The Commission determined that the expert testimony in support of chelation therapy was admissible under section 490.065. The Board does not challenge this finding, contending only that evidence was insufficient to satisfy the more rigorous Frye rule. Given the Supreme Court's most recent directive to follow section 490.065 (without any mention of Frye), we find no error in the Commission's application of the statute. Lasky, 936 S.W.2d at 801. See also Hobbs, 969 S.W.2d at 322; Fierstein, 24 S.W.3d at 226. Regardless of whether the evidence satisfied Frye, it was admissible upon the Commission's reasoned determination that the threshold provisions of section 490.065 were met.
B. Sufficiency of Expert Testimony
The Board further argues that even if the medical expert testimony was admissible, the Commission could not rely on this evidence because the experts failed to establish that chelation therapy met the standard of care required under Missouri law. While Dr. McDonagh and his experts mentioned the phrase "standard of care," they never defined this key term or explained how chelation therapy met its requirements under Missouri's statutory definition of negligence. The Board contends this omission rendered the testimony unreliable because the Commission was unable to determine whether the experts were evaluating the practice of chelation therapy under the objective legal standard of negligence. See Ladish v. Gordon, 879 S.W.2d 623, 634 (Mo.App.W.D. 1994).
The Board's Complaint alleged that Dr. McDonagh's practice of chelation therapy constituted repeated negligence in violation of section 334.100.2. The statute defines repeated negligence as "the failure on more than one occasion, to use that degree of skill and learning ordinarily used under the same similar circumstances by the members of the applicant's or licensee's profession." § 334.100.2(5). This definition establishes the legal standard of care that must be applied in determining the Board's claims of repeated negligence in Counts I, II, III, IV, V, VII, IX, X, XI, XII, and XIII of the Complaint.
Dr. McDonagh presented expert testimony in an effort to rebut the Board's allegation that his practice of chelation therapy did not meet the standard of care. Although the experts testified to the benefits and effectiveness of chelation therapy, Dr. McDonagh does not dispute on appeal that none of his experts defined the standard of care by which such effectiveness could be measured. Our court has previously held that mere use of the term "standard of care" does not satisfactorily articulate the appropriate legal standard for negligence. Ladish, 879 S.W.2d at 634. By necessity, the fact finder must be informed as to whether the expert "is using the standard prescribed by law and not some other standard." Id.
In denying the Board's claims of repeated negligence, the Commission expressly relied on the testimony of Dr. McDonagh and his experts that "chelation therapy treatments provide relief to some people and cause physical harm to no one." This testimony was insufficient to rebut the Board's claim of repeated negligence because it failed to establish that Dr. McDonagh's practice of chelation therapy was consistent with the degree of skill or learning ordinarily used by physicians treating vascular disease in geriatric patients. Our review of the record indicates there is no substantial evidence that chelation therapy met the standard of care under Missouri law. We must therefore reverse and remand the Commission's decision on Counts I, II, III, IV, V, VII, IX, X, XI, XII, and XIII for further consideration in light of the applicable standards set forth in Section 334.100.2(5).
Remaining Points on Appeal
As an alternative to Point I, the Board argued in Point II that the Commission's reliance on Dr. McDonagh's expert testimony was an erroneous application of Missouri's standard of care because EDTA chelation therapy is "against the course recognized as correct by the medical profession generally." Our holding on Point I obviates any need for further discussion on this issue, as the Commission has been directed to properly apply the standard of care on remand.
In its third point, the Board contends the Commission failed to make findings of fact on its Count I allegations of misrepresentation with regard to the effectiveness of chelation therapy in treating various conditions. Dr. McDonagh does not dispute the absence of findings but argues the Commission implicitly found no misrepresentation based on its determination that chelation therapy was an effective treatment method. Given our holding that this determination is not supported by substantial evidence, on remand the Commission shall reconsider the evidence and make findings of fact and conclusions of law on the misrepresentation claim in Count I.
The Board's fourth point on appeal is that the Commission arbitrarily rejected its allegations that Dr. McDonagh failed to document medical procedures and properly maintain patient records. The Commission concluded no disciplinary action was warranted because "no Missouri law or regulations set forth standards or recommendations" for the maintenance of medical records. We note, however, that the Board did not assert inadequate recordkeeping as an independent cause of action; rather, the Complaint alleged the deficiencies as a factor in support of the Board's claims of repeated negligence in Counts II, III, IV, V, X, and XII. To support this assertion, the Board presented expert testimony that Dr. McDonagh's recordkeeping practices fell below the standard of care set forth in section 334.100.2(5). The Commission erred in failing to consider this evidence in the context of the repeated negligence claim. On remand, the Commission shall review the evidence and make findings and conclusions of law as to whether Dr. McDonagh's recordkeeping practices violated the applicable standard of care.
Similarly, in its fifth point, the Board contends the Commission failed to make findings of fact and arbitrarily rejected claims that Dr. McDonagh conducted inappropriate and unnecessary testing on patients in violation of sections 334.100.2(4)(c)and 334.100.2(5). To support these claims in Counts VII, VIII, IX, XI and XII, the Board presented expert testimony that Dr. McDonagh prescribed "hemoglobin A1C testing" for non-diabetic patients for whom such procedures are not medically necessary. The Commission rejected these claims based on the testimony of Dr. McDonagh and his experts that the tests were appropriate under the circumstances. However, this testimony does not constitute substantial evidence in light of our holding that the experts failed to define the standard of care on which their conclusions were based. On remand, the Commission shall reconsider the evidence and make findings and conclusions of law as to whether Dr. Donagh's hemoglobin A1C testing met the standards of care set forth in sections 334.100.2(4)(c) and 334.100.2(5).
Section 334.100.2(4)(c) prohibits a medical licensee from "[w]illfully and continually performing inappropriate or unnecessary treatment, diagnostic tests or medical or surgical service[s]."
Finally, in response to all of the Board's points on appeal, Dr. McDonagh argues the Commission did not err in refusing disciplinary action because of his constitutionally protected right to determine appropriate medical treatment for his patients as a licensed practitioner. This argument is based on Rogers v. State Board of Medical Examiners, 371 So.2d 1037 (Fla.Dist.Ct.App. 1979), aff'd 387 So.2d 937 (Fla. 1980), wherein the Florida courts quashed an order of reprimand against a physician and held that the state licensing board unreasonably restricted the physician's right to practice medicine and treat patients with chelation therapy where there was no evidence of harm or deception. We note that Rogers predates published studies (i.e. the 1992 Guldager study and the 1994 van Rij study) disputing the efficacy of chelation therapy and, in any event, is not binding authority in Missouri. Given our remand and the absence of disciplinary action against Dr. McDonagh to date, his constitutional claims are premature and do not preclude the Commission from reviewing the evidence consistent with our instructions herein.
Conclusion
The Commission's findings of facts and conclusions of law with regard to Counts I, II, III, IV, V, VII, VIII, IX, X, XI, XII, and XIII are reversed and remanded for further consideration of the evidence in light of our instructions herein.
Dr. McDonagh's Motion to Strike Appellant's Brief is denied.
Although Appellant's brief does not fully comply with Rule 84.04, we decline to strike any portion of it because the technical deficiencies do not impede our ability to determine the issues on appeal. See Geiersbach v. Blue Cross/Blue Shield , 58 S.W.3d 636, 639 (Mo.App.W.D. 2001).
All concur.