Court Opinion

ID: 9640590
Source: CourtListenerOpinion
Date Created: 2023-08-22 17:09:07.434345+00
Date Added: 2024-06-11T18:05:06.999859
License: Public Domain

WOLFF, Judge,
concurring in part and dissenting in part.
I concur that section 490.065 sets the standards for admissibility and use of expert testimony. Because I believe that the Administrative Hearing Commission was correct in concluding that Dr. McDonagh was not subject to discipline for any of the acts alleged by the State Board of Registration for the Healing Arts, I would affirm the commission’s decision, as the circuit court did.
I write separately to offer advice to lawyers on expert witnesses and gentle advice for the board on the future of this case against Dr. McDonagh.
Advice for Lawyers on Expert Witnesses
The principal opinion’s discussion of section 490.065 is worth reading for its excellent legal analysis. I would only add a helpful summary for practitioners in Missouri courts and administrative agencies:
Forget Frye. Forget Daubert. Read the statute. Section 490.065 is written, conveniently, in English.1 It has 204 words. Those straightforward statutory words are all you really need to know about the admissibility of expert testimony in civil proceedings. Section 490.065 allows expert opinion testimony where “scientific, technical or other specialized knowledge will assist the trier of fact. 2
*161Dr. McDonagh and the physicians he called as expert witnesses surely were “qualified” as experts by “knowledge, skill, experience, training, or education.... ” The board argued that these witnesses’ testimony was inadmissible under Frye v. United States, 293 F. 1013 (D.C.Cir.1923). Frye was remarkably beside the point.
Neither party gave the statute due regard. The board conceded that the testimony of Dr. McDonagh and his experts was admissible under section 490.065 but inadmissible under Frye. Why would an 80 year old federal court of appeals case trump a Missouri statute directly on point?
Dr. McDonagh argued, by contrast, that the applicable standard was that of Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). Again, why would a Missouri statute directly on point be disregarded in favor of a United States Supreme Court decision on the Federal Rules of Evidence, which have not been adopted in Missouri?
What I think the parties are trying to get to is the relevant standard of care, discussed in the principal opinion. There is a problem here: in the proceedings before the commission, the board raised only the general objection that Dr. McDonagh’s expert evidence would not qualify under Frye. The board did not object to any specific testimony from Dr. McDonagh or his experts. The board also did not raise the point it now presses in this appeal that Dr. McDonagh’s experts did not define the standard used when they stated that his use of chelation therapy was in accord with the “standard of care.” The board’s evi-dentiary motion before the commission made no reference to “standard of care,” nor did the board take the opportunity to cross-examine Dr. McDonagh’s expert witnesses as to the standard of care. It was not Dr. McDonagh’s burden to establish the relevant standard of care.
But the question of “standard of care” may be beside the point, as I will discuss in the next section in offering advice to the board.
Advice for the Healing Arts Board
The board should drop this case. It should not waste another dollar of public money on its case against Dr. McDonagh.
The board’s case against Dr. McDonagh is premised on its contention that Dr. McDonagh’s use of chelation therapy constitutes repeated negligence for which he should be disciplined. The board lost its case before the administrative hearing commission and then appealed to the circuit court, where it also lost.
Less than a month after the board filed its notice of appeal in 2001, the board promulgated a rule, 4 CSR 150-2.165, that declares the use of chelation on a patient is of “no medical or osteopathic value” except for such uses as approved by the federal Food and Drug Administration (FDA). The rule also says that the board “shall not seek disciplinary action” against a licensee where the licensee uses a patient consent form prescribed by the rule.
*162The board concedes, and the principal opinion appropriately notes, that the consent form that Dr. McDonagh has used for many years is very similar to the consent form in the board’s rule.
How can the board take the position that Dr. McDonagh’s practice was repeatedly negligent under the disciplinary statute, section 334.100, when the board has a rule saying that it will not seek discipline against physicians engaging in this practice? What, exactly, is the standard of care?
The real question is: Is the healing arts board’s use of section 334.100, which prescribes discipline for repeated acts of “negligence,” an inappropriate use of the disciplinary process to impose the board’s sense of orthodoxy?3
Dr. McDonagh’s use of chelation therapy to treat atherosclerosis and other vascular diseases may be unorthodox. None of the mainstream medical organizations endorse its use for vascular diseases. But, until 2001 — after the acts the board complains of in this proceeding — there was no law or regulation regulating its use. Che-lation therapy, which consists of administering the drug EDTA intravenously, is standard treatment for removal of heavy metals from the body. The FDA approves the chelation therapy medications for this use. Its use in attempting to clear vascular blockage is called an “off-label” use, referring to the use of a standard therapy for another purpose. There are many off-label uses of medicines that are generally accepted by the medical profession.
An organization called the American College for Advancement in Medicine, consisting of about 1,000 physicians worldwide including Dr. McDonagh, endorses the off-label use of chelation therapy, along with various vitamins and minerals, for treating vascular disease.
The administrative hearing commission heard evidence for eight days on the board’s complaint against Dr. McDonagh for his use of chelation therapy and related matters.4 The commission, in its 70 pages of findings of fact and conclusions of law, found no cause for discipline.
Specifically responding to the board’s position that the use of chelation therapy is cause for discipline, the commission concluded: “It is not an unnecessary, harmful or dangerous treatment.” The commission characterized McDonagh’s conduct as “giv*163ing patients a treatment that has provided benefit to many patients, harms no one, and is given with informed consent and the information that this treatment may not work with all patients.” The commission further stated, “[T]he evidence shows that patients are being helped. We cannot state that an entire treatment method that provides benefits to patients without harming them constitutes incompetent, inappropriate, grossly negligent, or negligent treatment. Nor can we say that this treatment is misconduct, unprofessional, or a danger to the public.”
The commission, based on the record, does acknowledge that chelation therapy involves risks, as of course do other treatments for vascular disease, such as coronary artery surgery. The risks of chelation therapy are disclosed, according to the commission, in the informed consent form that Dr. McDonagh has used with all his patients. The form gives notice that che-lation therapy for vascular disease is not approved by the FDA, the American Medical Association, or others. It lists possible benefits, but also notes “you may not receive all of these benefits as they do not occur predictably with every patient and in some cases may not occur at all.” Dr. McDonagh tells his patients that “the treatment will work better if the patient follows the diet, exercise and nutritional supplements that are recommended,” according to the commission’s findings.
There are scientific studies discussed in the commission’s findings as to the efficacy of chelation therapy for vascular conditions. The mainstream organizations accept the conclusions of studies that found no value in treating vascular disease by chelation therapy. Dr. McDonagh and other like-minded physicians, including their American College for Advancement in Medicine, cite case reports and studies — arguably of less validity than the studies relied upon by the mainstream— that show benefits in such use of chelation therapy.
There is a provision of section 334.100 that would seem to cover unorthodox treatments that are of no value. Section 334.100.4(f) provides for discipline where a licensee performs or prescribes “medical services which have been declared by board rule to be of no medical or osteopathic value.” But the board did not have a rule against chelation therapy that would apply to Dr. McDonagh’s acts, which occurred from 1978 to 1996. The board, long after the acts included in its complaint against Dr. McDonagh, promulgated a rule relating to chelation therapy, 4 CSR 150-2.165 (Effective October 30, 2001), quoted in full in the principal opinion.
More to the point, when the board finally promulgated its rule that declares chelation therapy to be “of no medical or osteopathic value,” the board’s rule goes on to provide that 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 form that accompanies the regulation. As noted here and in the principal opinion, the consent form that Dr. McDonagh used for these patients — long before the consent form promulgated by the board — is very similar to the consent form accompanying the 2001 rule.
At this point, the question becomes: what’s going on here? In fairness to the board, I should note that the hearing before the administrative hearing commission in Dr. McDonagh’s case was held in 1997, four years before the board promulgated its rule. But it seems strange that the board, having lost in the commission and in the circuit court, would press its claims on appeal after publishing the 2001 rule that undercuts its position.
*164As to the board’s claims heard in 1997 that are the subject of this appeal, it appears that the absence of a rule left the board to proceed against Dr. McDonagh under 334.100.2(5) for repeated acts of negligence. The board’s complaint alleged that Dr. McDonagh’s practice of chelation therapy constituted repeated negligence in violation of section 334.100.2. Section 334.100.2(5) allows for discipline for “any conduct or practice which is or might be harmful or dangerous to the mental or physical health of a patient or the public,” and for “incompetency, gross negligence or repeated negligence” in professional duties. Section 334.100.2(5) defines “repeated negligence” as “the failure, on more than one occasion, to use that degree of skill and learning ordinarily used under the same or similar circumstances by the member of the applicant’s or licensee’s profession.” This definition establishes the legal standard of care that must be applied in determining the board’s claims of repeated negligence.
So is this off-label use of chelation therapy negligence? The real question — the answer to which is fatal to the board’s position — is whether acts of negligence, as defined by this statute, can be cause for discipline if there is no showing that the physician’s conduct “is or might be harmful or dangerous.” If there is no harm or danger, there is no cause for discipline under this section. Section 334.100.2(5) is a catchall provision; read in the context of the entire statute, it does not make negligent acts actionable unless there is harm or danger.5 This subdivision cannot be read to make acts subject to discipline where there is no prospect of harm. If it were so read, the reading would make superfluous other provisions of the statute, such as 334.100.2(4)(f) as to treatments deemed by rule to have no medical value. There are provisions in section 334.100, including 334.100.2(4)(f), for disciplining medical quackery — even where it causes no harm. But section 334.100.2(5), under which the board complains of Dr. McDo-nagh’s practice, is not one of those sections.
Under section 334.100.2(5), no harm, no foul.
Physicians are afforded considerable leeway in the use of professional judgment to decide on appropriate treatments, especially when applying the negligence standard. For instance, Haase v. Garfinkel, 418 S.W.2d 108, 114 (Mo.1967), a medical negligence case, holds that “as long as there is room for an honest difference of opinion among competent physicians, a physician who uses his own best judgment cannot be convicted of negligence, even though it may afterward develop that he was mistaken.” “Negligence” does not seem an appropriate concept where the physician has studied the problem and has made a treatment recommendation, even though that is not the prevailing view of the majority of the profession. The lack of general acceptance of a treatment does not *165necessarily constitute a breach of the standard of care. The use of negligence in licensing situations, in the absence of harm or danger, is particularly inappropriate.
One could argue that because chelation therapy is not accepted by mainstream medicine and is an off-label practice not approved by the FDA, it is therefore harmful and dangerous. If that were the board’s position, the licensing statute would thwart advances in medical science. A dramatic example is the treatment of stomach ulcers, which were long thought to be caused by stress. In 1982, two Australians found the bacterium helicobacter pylori in the stomach linings of ulcer victims. Because helicobacter pylori is a bacterium, some physicians — a minority to be sure — began prescribing antibiotics to treat stomach ulcers as an infectious disease. The National Institutes of Health did not recognize antibiotic therapy until 1994; the FDA approved the first antibiotic for use in treating stomach ulcers in 1996; and the Centers for Disease Control began publicizing the treatment in 1997. Today’s physicians accept as fact that most stomach ulcers are primarily caused by helicobacter pylori bacteria infection and not by stress.6 But, by the chronology of this discovery, if a physician in the late 1980s or early 1990s had treated ulcers with antibiotics, that treatment would have been “negligent” as the board in this case interprets that term because inappropriate use of antibiotics can be dangerous.
I do not mean to suggest that chelation therapy for vascular disease is of the same order as the use of antibiotics for treating stomach ulcers. In fact, I doubt it. But my point is that medicine is not readily regulated by a standard cookbook or set of rules. The board’s position in publishing its 2001 rule on chelation therapy seems to recognize this point better than its position in this disciplinary action. If chelation therapy for vascular disease were dangerous, the board’s rule that allows its use would be unconscionable.
In Dr. McDonagh’s practice, all of his patients signed a consent to medical treatment and agreement that discusses the positive and negative aspects of chelation therapy and possible side effects. The patients are told that the therapy is not approved by the FDA, AMA or others. The patients consented nonetheless. Some of Dr. McDonagh’s patients chose chelation therapy after exhausting more traditional medical treatments. Some may have benefited, perhaps because Dr. McDonagh accompanied the chelation treatment with recommendations for diet and exercise that are well known to be helpful for preventing and resolving some vascular disease. The record shows no harm to any patient.
In the absence of harm, or the probability of harm, can the repeated negligence standard of the licensing statute legitimately be used to enforce the board’s opinion of what is conventional and, therefore, acceptable medicine?
The board conceded that there was no evidence of harm from chelation therapy. In the 35 years that he has used chelation therapy, Dr. McDonagh reports that the therapy has not resulted in infection, injury, or death for any of his patients. The commission repeatedly found that chelation therapy “harms no one” and provides “benefit to many patients.”7
*166Medicine is an art, as well as a science, as its practitioners are taught. It is also a dynamic field, where beliefs about what is conventional therapy can change over time. What is effective treatment is often a combination, not just of art and science, but of belief. The patient may get better if the patient is convinced of the usefulness of the therapy. The commission concluded that some of Dr. McDonagh’s patients got better. Even if it is hard to believe these patients got better because of chelation therapy, the fact that some of Dr. McDo-nagh’s patients got better is hardly cause for discipline. On this record, the absence of harm from chelation therapy, as I read the statute, negates the board’s claim of repeated negligence.
Nor can it be said that the board or the commission believes that Dr. McDonagh’s practice constitutes a danger to the public. The board has the power to move quickly to end practices that it considers dangerous. Section 334.102. The board sought no such immediate action.
This disciplinary action has, if anything, been conducted in slow motion. The healing arts board in 1989 apparently studied chelation therapy and issued a public statement that it chose “to take no action concerning chelation therapy” and would consider cases as they arose. Its first complaint against Dr. McDonagh was filed in 1994 but later dismissed without prejudice. The current complaint, in 13 counts, covers practices going back to 1978 and was filed in 1996. As noted, the current case was tried before the commission in 1997, but the commission’s decision was not issued until 2000. There has been a noticeable lack of urgency by all concerned.
If this matter comes before the commission on remand, the commission is to review the evidence on the basis of the evi-dentiary principles in section 490.065. In my view, the commission should reach the same conclusion as before. In any event, to the extent that Dr. McDonagh’s practice though it pre-dated the board’s 2001 regulation conformed to the board’s regulation on chelation, the board ought to be bound by its own standard. Dr. McDonagh has not yet raised the issue of whether the board should be bound by its own standard as expressed in its 2001 rule. But he will have the opportunity to do so on remand.
This case needs to be over. The board should end the case itself rather than suffer the indignity of further adverse commission and judicial rulings, to say nothing of the waste of public resources that such proceedings will entail.

. All statutory references are to RSMo 2000.

. Section 490.065, in its entirety, provides:
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. Testimony by such an expert witness in the form of an opinion or inference otherwise admissible is not objectionable because it em*161braces an ultimate issue to be decided by the trier of fact.
3. The facts or data in a particular case upon which an expert bases an opinion or inference may be those 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.
4. If a reasonable foundation is laid, an expert may testify in terms of opinion or inference and give the reasons therefor without the use of hypothetical questions, unless the court believes the use of a hypothetical question will make the expert's opinion more understandable or of greater assistance to the jury due to the particular facts of the case.

. Section 334.100.2 provides, in pertinent part:
The board may cause a complaint to be filed with the administrative hearing commission as provided by chapter 621, RSMo, against any holder of any certificate of registration or authority, permit or license required by this chapter or any person who has failed to renew or has surrendered the person’s certificate of registration or authority, permit or license for any one or any combination of the following causes: (5) Any conduct or practice which is or might be harmful or dangerous to the mental or physical health of a patient or the public; or incompetency, gross negligence or repeated negligence in the performance of the function or duties of any profession licensed or regulated by this chapter. For the purposes of this subdivision, "repeated negligence” means the failure, on more than one occasion, to use that degree of skill and learning ordinarily used under the same or similar circumstances by the member of the applicant’s or licensee’s profession!.]

. The board’s complaint also relates to record keeping and use of diagnostic tests, but these charges seem to be premised on the board’s objection to Dr. McDonagh’s practice of che-lation therapy for treating vascular disease. There may be a question whether Dr. McDo-nagh ordered unnecessary tests, without reference to chelation therapy, or whether the tests Dr. McDonagh ordered were deemed by the board to be unnecessary because they were part of chelation therapy that the board believes is useless.

. For those who like the comfort of case citations, Missouri's common law of negligence is consistent with this reading of section 334.100.2. In common law actions for negligence, the concept of negligence is inextricably linked to the causation of harm. All actions for negligence require a plaintiff to establish that "the defendant had a duty to protect her from injury, that the defendant breached that duty, and that the defendant's failure directly and proximately caused her injury." Robinson v. Health Midwest Development Group, 58 S.W.3d 519, 521 (Mo. banc 2001). For a medical negligence action, a plaintiff must prove that the defendant failed to use that degree of skill and learning ordinarily used under the same or similar circumstances by members of defendant’s profession and that the negligent act or acts caused plaintiff’s injury. Washington by Washington v. Barnes Hosp., 897 S.W.2d 611, 615 (Mo. banc 1995).

. The treatment of stomach ulcers by antibiotic therapy is cited as one of the top innovations in medicine in the past 25 years in a study sponsored by the Robert Wood Johnson Foundation and the Henry Kaiser Foundation. Its conclusions are summarized at www.MedTechl.com.

. In contrast, according to the commission, cardiac bypass surgery — an approved therapy *166for severe athlerosclerosis — has an operative mortality rate of between two and 30 percent, depending on where you are in the United States, and mental impairment occurs in as many as 18 percent of cardiac bypass patients.