The Issue Whether the Respondent committed the violations set forth in the Amended Administrative Complaint dated November 19, 1998, and, if so, the penalty which should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: The Board of Osteopathic Medicine is the entity responsible for imposing discipline on those licensed in Florida as osteopathic physicians. Section 459.015(2), Florida Statutes. The Department of Health is the state agency responsible for investigating and prosecuting disciplinary cases in which a probable cause panel of the Board of Osteopathic Medicine has found probable cause to support the filing of a formal complaint against a licensee. Section 455.621(4), Florida Statutes. Christopher Wayne, D.O., was at the times material to this proceeding, and is currently, a licensed osteopathic physician in the State of Florida, specializing in family practice and certified by the American Osteopathic Board of Family Physicians. Dr. Wayne operated at the times material to this proceeding, and currently operates, a primary care medical practice under the name of Dr. Christopher Wayne, D.O., Incorporated ("Company"). At the times material to this proceeding, the Company's office was located on the fifth floor in a building adjacent to the Mount Sinai Medical Center in Miami Beach, Florida. At the times material to this proceeding, Dr. Wayne and the physicians employed in his practice had staff privileges at several hospitals and medical centers in the Dade County area. However, at the times material to this proceeding, Dr. Wayne did not have staff privileges at Parkway Regional Medical Center ("Parkway"). At least one physician employed by the Company, Agustin Andrade, had staff privileges at Parkway. Dr. Wayne began discussions with Agustin Andrade with respect to his possible employment by the Company as a family practice physician in or around June 1995. Dr. Andrade is a medical doctor who completed a three-year residency in internal medicine and a two-year fellowship in endocrinology at the University of Miami, in Miami, Florida; he is board-certified in internal medicine and endocrinology. Dr. Andrade was also a citizen of Ecuador at the times material to this proceeding. On July 7, 1995, Dr. Andrade signed an Employment Agreement with the Company, and he began working for the Company in October 1996. The delay was attributable to Dr. Andrade's need to obtain legal residency and authority to work in this country. He obtained legal residency and authorization to work in this country in June 1996, and he obtained his green card, representing the permanent right to stay in this country, in February 1997. As part of the process for obtaining a green card, Dr. Andarde completed a HUD J-1 Visa Waiver Policy Affidavit and Agreement in which he agreed to the following conditions: I understand and agree that in consideration for a waiver, . . . I shall render primary medical services to patients, including the indigent, for a minimum of forty (40) hours per week within a USPHS designated HPSA. Such service . . . shall continue for a period of at least two (2) years. I agree to incorporate all the terms of this HUD J-1 Visa Waiver Affidavit and Agreement into any and all employment agreements I enter pursuant to paragraph 3 and to include in each such agreement a liquidated damages clause, of not less than $250,000 payable to the employer. This damages clause shall be activated by my termination of employment, initiated by me for any reason, only if my termination occurs before fulfilling the minimum two year service agreement. Soon after he began working for the Company, Dr. Andrade's professional relationship with Dr. Wayne deteriorated rapidly for a variety of reasons. After two weeks, Dr. Andrade told Dr. Wayne that he wanted a raise because he had learned that the other physician employed by the Company at the time was paid a higher salary than he was paid. Dr. Andrade also accused Dr. Wayne of forcing him to engage in what Dr. Andrade termed "illegalities," of forcing him to see too many patients at too many different hospitals, and of requiring him to see pediatric patients, which he did not feel he was qualified to treat. On January 7, 1997, Dr. Wayne and Dr. Andrade were the only physicians employed by the Company. On the evening of January 7, 1997, medical orders were given by telephone for three of Dr. Andrade's patients hospitalized at Parkway. The physician order forms indicate that the person giving the orders was Dr. Andrade. Dr. Andrade denies giving these orders, and he subsequently refused to accept responsibility for the orders by declining to sign them. At around 8:00 p.m. on January 9, 1997, Dr. Andrade went to Parkway and spoke with the nurses in Parkway's surgical intensive care unit, specifically Ann Bravi, a registered nurse who has been employed at Parkway for twenty-eight years. Dr. Andrade told Nurse Bravi that someone was impersonating him and giving telephone orders for his patients. While Dr. Andrade was standing beside her, Nurse Bravi called Dr. Andrade's answering service regarding one of his patients. The call was returned by someone who identified himself to Nurse Bravi as Dr. Andrade and who told her that there would be "[n]o orders for now." Nurse Bravi cannot recall whether she telephoned the answering service at Dr. Andrade's request or on her own initiative, nor could she recall whether she called the answering service number noted on the patient's chart or called a number that Dr. Andrade gave her. On Friday, January 10, 1997, Dr. Andrade terminated his employment with the Company, accusing Dr. Wayne of having breached the Employment Agreement by impersonating him with the staff at Parkway and by giving telephone orders on Dr. Andrade's patients at Parkway. On Monday, January 13, 1997, Dr. Andrade was distributing business cards indicating that he was practicing medicine with another physician, whose offices were located on the first floor of the building in which the Company's office was located. The Company has sued Dr. Andrade for damages resulting from breach of contract, and Dr. Andrade has sued Dr. Wayne for defamation. At the time of the final hearing, both lawsuits were pending in the Circuit Court of the 11th Judicial Circuit in and for Dade County, Florida. If an osteopathic physician gives medical orders by telephone for a patient who is not his patient and who is hospitalized in a facility at which he does not have medical staff privileges, then that physician has acted in a manner inconsistent with ethics and the standard of care practiced by an osteopathic family physician. The osteopathic physician has further acted in a manner inconsistent with ethics and the standard of care practiced by an osteopathic family physician if that physician gives telephone orders using the name of another physician. The evidence presented by the Department is insufficient to establish with the requisite degree of certainty that Dr. Wayne gave telephone orders for any of Dr. Andrade's patients at the Parkway Regional Medical Center or that he identified himself as Dr. Andrade in telephone conversations with staff at the Parkway Regional Medical Center.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Osteopathic Medicine enter a final order dismissing the Amended Administrative Complaint against Christopher Wayne, D.O. DONE AND ENTERED this 28th day of October, 1999, in Tallahassee, Leon County, Florida. PATRICIA HART MALONO Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 28th day of October, 1999.
Findings Of Fact At all times here relevant Theodore S. Brandwein, D.O., held License No. 3259 issued by the Board of Osteopathic Medical Examiners. During the calendar year 1977 and for some period subsequent thereto Respondent maintained his office and practice at 18055 Franjo Road, Perrine, Florida under the name of Brandwein Medical Practice, P.A. The sign marking Respondent's office in 1977, when these charges were preferred, is the same sign depicted in Exhibit 6 which is a photograph taken in 1979. It is the sign for which Respondent registered with the Florida Secretary of State as a service mark. In his application (Exhibit 11) for this registration Respondent described this mark as "a stethoscope, binaural in design, lying horizontally on the paper, sign, building, item, or object on which it is emblazoned, the earpieces and connecting piece forming in script the letter 'D' and the tubing and chest piece convoluted to form the 'O'. Taken together, the stethoscope forms the letters 'D. O.'" The application further provided "applicant is the owner of the mark and no other person except a related company has the right to use such mark in Florida, whether in identical form thereof, or in such resemblance thereto as might be, calculated to deceive or confuse". The sign on Respondent's office in 1977 consisted of this mark depicting a convoluted stethoscope which forms the letters "D.O." only after the exercise of a vivid imagination and an appreciation of surrealistic art. In the yellow pages of the 1977 Miami telephone directory Respondent is listed under Physicians and Surgeons MD. (Exhibit 9). He is not listed under Physicians and "Surgeons - DO. (Exhibit 10). Brandwein Medical Practice, P.A., is the Theodore S. Brandwein who is Respondent in these proceedings. Respondent's Florida license is presently inactive.
The Issue Respondent is charged, pursuant to Count I with a violation of Section 459.015(1)(h) in that he allegedly failed to perform any statutory or legal obligation placed upon a licensed physician by his alleged violation of Section 459.0154 Florida Statutes, which statute sets forth requirements of physicians who treat with the substance dimethyl sulfoxide ("D.M.S.O."), pursuant to Count II, with a violation of Section 459.015(1)(o) in that he allegedly exercised influence on a patient in such a manner as to exploit the patient for financial gain, pursuant to Count III, with a violation of Section 459.015(1)(t) in that he allegedly committed gross or repeated malpractice or failed to practice medicine with that level of care; skill and treatment which is recognized by a reasonably prudent similar osteopathic physician as being acceptable under similar conditions and circumstances, pursuant to Count IV, with a violation of Section 459.015(1)(u) in that he allegedly performed a procedure or prescribed a therapy which, by the prevailing standards of medical practice in the community would constitute experimentation on human subjects; pursuant to Count V, with a violation of Section 459.015(1)(n), in that he allegedly failed to keep written medical records justifying the course of treatment of a patient, including but not limited to patient histories, examination results and test results; and pursuant to Count VI, with a violation of Section 459.015(1)(1); in that he allegedly made deceptive untrue or fraudulent representations in the practice of osteopathic medicine or employed a trick or scheme in the practice of osteopathic medicine when such trick or scheme fails to conform to the generally prevailing standards of treatment. Counts VII and VIII, were severed, to remain pending in the instant action until such time as Petitioner should file a voluntary dismissal thereof or a notice that same were ready for hearing. Petitioner had every opportunity to resolve this state of the pleadings and did not do so. PROCEDURAL AND EVIDENTIARY MATTERS At formal hearing, Respondent and Gregory D. Seeley, Esquire, were examined pursuant to Rules 22I-6.05 and 28-5.1055 F.A.C. and Gregory D. Seeley, an Ohio attorney, was determined to be a qualified representative of Respondent for purposes of this cause only. Respondent thereafter attempted to file a formal written answer, which request was denied pursuant to Rules 22I- 6.04 (5) and 25- 5.203 F.A.C. Petitioner presented the live testimony of Frank R. Laine, Lloyd D. Gladding, D.O., Jeffrey Erlich, M.D., William Pawley, Respondent Wilfred Mittlestadt, D.O., Mark Montgomery, Ph.D., and the deposition testimony of Wilbur Blechman, M.D. Petitioner offered 12 exhibits, all of which were admitted in evidence. Deposition of Dr. Blechman is Petitioner's Exhibit 4 and Petitioner's Requests for Admission with extensive Answers thereto are Petitioner's Composite Exhibit 1, within the twelve. A request of Petitioner for judicial notice was denied. Respondent testified on his own behalf. Respondent also was permitted to late-file the depositions of Garry Gordon, M.D., and Stanley Jacobs, M.D. Inasmuch as the transcripts of those depositions were timely filed, they are admitted in evidence as Respondent's Exhibits 4 and 5 respectively. Respondent offered 3 exhibits in evidence; all were excluded. Exhibits not admitted or at least proffered were not retained as part of the record. A number of requests for judicial notice by Respondent were also denied. In the course of formal hearing, Respondent also made several motions for mistrial and/or recusal of the undersigned due to admission in evidence of what Respondent characterized as "prejudicial material." None of these motions was meritorious and all were denied, but a discussion of these rulings is also incorporated within this recommended order. By agreement at hearing and without subsequent objection, copies of those matters actually judicially noticed by the undersigned were attached by the parties to their respective post-hearing proposals. The parties' pre-hearing stipulation (H.O. Exhibit 2 as interlineated) also included stipulations as to many facts and has been extensively utilized in preparation of this recommended order. At the close of Petitioner's case in chief Respondent moved to dismiss the pending charges as unproved. This motion was taken under advisement for resolution within this recommended order. The motion was renewed within Respondent's post-hearing proposals with written argument. The Motion to Dismiss within Respondent's post-hearing proposals also renews all previous motions to dismiss, incorporating by reference what may be read as previous arguments concerning procedural and pleading irregularities as to Counts VII and These issues are also disposed of within this recommended order. Transcript of formal hearing was provided by Petitioner, who filed its proposed findings of fact and conclusions of law beyond the 10 day limitation. Respondent's proposed findings of fact and conclusions of law were timely filed. The late-filing of Petitioner's proposals without objection by Respondent are deemed a waiver of the 30 days for entry of this recommended order pursuant to Rule 22I-6.31 F.A.C., but all proposals have been considered and Petitioner's proposed findings of fact and Respondent's proposed findings of fact are ruled on in the appendix hereto.
Findings Of Fact At all times material, Respondent was licensed as an osteopathic physician in the State of Florida having been issued license number 05 0001510. He has practiced approximately 40 years. On April 4, 1983 Frank R. Laine went to Bio-Equilibrium Testing located in Ft. Lauderdale, Florida. Laine complained of pain in his hands, feet, knees, and shoulders. On five different visits, Laine saw a Diane La Berge. At all times material hereto, Diane La Berge was not licensed to practice either medicine or osteopathic medicine in the State of Florida but held herself out as a homeopathic physician and Director of Bio-Equilibrium Testing. She conducted a series of "tests" and made "evaluations" regarding Laine's condition. Among the tests performed was a metal analysis based on a cutting of Laine's hair sent to Biochemical Concepts, a testing laboratory. Based on her evaluation of the results of the hair analysis for metal La Berge diagnosed Laine as suffering from "heavy or acute copper poisoning". As treatment therefore La Berge recommended chelation therapy, acupuncture, and numerous "supplements", presumably vitamins. Laine understood, based on his conversations with La Berge, that chelation therapy would "cure" his condition. Laine attempted, on a couple of occasions, to obtain chelation therapy from a physician recommended by La Berge; however, there was never anyone at that physician's office. Therefore, Laine went to Respondent's office after being referred by Dr. Harvey Frank, Laine's personal chiropractor. There is absolutely no proof of any connection or relationship of any kind between La Berge or Bio-Equilibrium Testing and Respondent. About two months prior to his seeking out Bio- Equilibrium, Laine, a boat captain, had sanded the hull of a boat coated with a copper-based paint. He performed this type of work approximately once a year, always outdoors with adequate ventilation. Laine informed Respondent that he had been scraping the hull of a copper boat and brought a copy of the hair analysis to their initial office consultation on May 16, 1983. Laine initially presented himself to Respondent seeking chelation therapy on May 16, 1983. He complained of constant pain in his hands, feet, knees, and shoulders. Respondent obtained a medical history based in part on responses to a Cornell Medical Index Health Questionnaire (CMI), a health questionnaire on Respondent's stationery, and another history form, which contained a description of symptoms, family history, and personal history. Some of these responses were filled in, not by Laine, but by his wife. Respondent also got a brief verbal history from Laine but did no extensive one-on-one questioning of Laine or verification of prior physicians and diagnoses listed by Laine and/or his wife. He did no questioning concerning all of the responses or even significant relevant responses. The significant relevant responses include a "yes" response to the question: "Are you crippled with severe rheumatism (arthritis)?" Laine's symptoms were consistent with a diagnosis of rheumatoid arthritis but Respondent only recorded "inflamed joints onset following scraping copper bottom of boat." There is no recorded physical examination of Laine by Respondent at this initial office visit or at any time thereafter. On May 16, 1983, Respondent diagnosed Laine as having "Copper poisoning as told by hair analysis," wrote this in his records, and administered intravenous chelation with 5cc. dimethyl sulfoxide (D.M.S.O.), intramuscular injections of zinc; and an intravenous injection of Phillpott's formula and sulfur cyl. Apparently, an oral dose of zinc was also prescribed. Respondent also obtained a urine specimen for analysis by tests which would be helpful in determining kidney function. Although there is clear evidence that Laine specifically requested chelation therapy of Respondent, there is no evidence that he ever requested administration of D.M.S.O. or any other substance specifically. Chelation therapy in general involves the use of certain chemicals called chelation agents to bind, immobilize, and in some instances to increase the excretion of a target molecule, in most cases heavy metals, so that the free amount in the blood is decreased more rapidly than the body would do absent the chelation therapy. Vitamin C and D.M.S.O. are not generally recognized as effective chelation agents. Both Vitamin C and D.M.S.O. have only weak binding properties. Phillpott's formula is an I.V. for allergies and a nutritional supplement containing Vitamin C and other vitamins and minerals. Among those testifying, only Dr. Gordon and Respondent, members of the American Academy of Medical Preventics, even recognized its name, absent a list of ingredients. Sulfur cyl is a salycilate useful in the treatment of inflamed joints and arthritis. D.M.S.O. is an organic solvent with the potential to dissolve the vascular system. At no time did Respondent obtain a written release from Laine, releasing Respondent from any liability for the administration of D.M.S.O. intravenously through chelation therapy. At a May 17, 1983 office visit, Respondent administered intravenous chelation with 5cc. D.M.S.O. and an intravenous injection of sulfur cyl to Laine. No further testing was done by Respondent on that day. On this date Laine indicated that he was subjectively feeling better. On May 19, 1983, Respondent administered intravenous chelation with D.M.S.O. and an intravenous injection of Phillpott's formula and sulfur cyl to Laine. D.M.S.O. was also prescribed topically for skin and shoulders as needed. Respondent also ordered copper levels to be obtained from blood and urine specimens. Laine provided a 24 hour urine specimen which Respondent had tested. The specimen analyzed at 74.8 micrograms per liter. The normal copper values for the laboratory in question were .00-60.00 micrograms per liter. The greater weight of the direct credible expert testimony is that Laine's test showed a mild elevation not diagnostically significant for acute copper poisoning, however some rheumatoid arthritis sufferers show elevated copper levels. Respondent received the results of this urine test on May 22, 1983. On May 23, 1983 Respondent administered chelation with D.M.S.O. and intravenous injection of sulfur cyl to Laine. D.M.S.O. 99.9 was prescribed topically for shoulders. No further testing was performed on that date. On May 24, 1983, Laine was administered intravenous chelation with D.M.S.O. and an intravenous injection of sulfur cyl by Respondent. A blood sample was drawn for testing. On May 25, 1983, Respondent administered an intravenous injection of sulfur cyl to Laine. At this visit, Respondent used a plethysmograph to study Laine's entire body. Plethysmography is used to measure pulse pressure, usually in the venous system, for determining impeded blood flow in the veins and was apparently done because of a response on Laine's medical history involving angina and prior myocardial infarctions and because of a protocol or teaching of the American Academy of Medical Preventics. The blood sample drawn on May 24, 1983 was tested. The tests performed included serum copper levels, a SMAC profile, and r.a. latex titer results. The results showed a serum copper level of 135 micrograms per deciliter (normal values 70-155) and an r.a. latex titer of 1/1280. The greater weight of the direct credible expert testimony is that these results are not indicative of significant copper poisoning but were one significant indicator of rheumatoid arthritis. The results were reported to Respondent on May 26, 1983. On May 26, 1983, Respondent administered intravenous chelation with D.M.S.O. with sulfur cyl and calcium disodium edetate (E.D.T.A.) added. Chelin was also prescribed, apparently orally. Blood urea nitrogen (BUN) levels were also obtained that day. E.D.T.A. is most often used in the treatment of mild to severe lead poisoning. Although E.D.T.A. will chelate other heavy metals, including copper, it is not the treatment of choice by the majority of medical and osteopathic physicians for treatment of either copper poisoning or rheumatoid arthritis. D- penicillamine is preferred over E.D.T.A. because it is more effective and because E.D.T.A. has significant side effects, including primarily kidney failure. E.D.T.A. also has a problem permeating cell membranes. On May 27, 1983, Respondent administered intravenous chelation with D.M.S.O. and sulfur cyl to Laine. In Respondent's discussions with Laine between May 16 and May 27, 1983, Respondent suggested that a reduction of Laine's copper level would improve his symptoms. Respondent did not fully inform Laine of any of the potential side effects of E.D.T.A. chelation therapy or intravenous D.M.S.O. Respondent told Laine that his treatment was not completely accepted in the general medical community but he believed in it and it would be acceptable. This falls far short of fully informing Laine as to alternative methods of treatment and their potential for cure of his condition. In total, Respondent billed Laine $1,350.00 for office visits, various tests, examinations, and treatments. At each visit, Respondent provided Laine with bills and health insurance claim forms. These do not reflect a diagnosis until May 26 and then only the single diagnosis of "toxic metal poisoning". The bills were never paid by Laine whose wife complained to the Department of Professional Regulation concerning Respondent's treatment of Laine when Laine's insurance declined to pay for Respondent's treatment of him. Despite Respondent's oral testimony to the contrary, the patient records do not reflect that Respondent diagnosed Laine as having rheumatoid arthritis or cardiovascular disease, they show only copper poisoning of various degrees as reflected in the above findings of fact. Respondent maintains that the many tests were necessary and conservative for the purpose of confirming or rejecting his initial diagnosis of copper poisoning, to determine the presence of rheumatoid arthritis, and to guard against potential kidney failure before E.D.T.A. chelation was attempted. Since Respondent never performed any "hands on" physical examination and did no one-on-one questioning of Laine concerning the medical history forms, the tests may appear excessive, particularly in light of the probability that E.D.T.A. was used on Laine before Respondent received the final test results, but the characterization of Dr. Blechman is accepted that the type and spectrum of tests including plethysmography actually ordered by Respondent do not demonstrate significant fault. Respondent's office staff regularly took readings of Laine's bloodpressure and pulsed and measured his height and weights but the patient records do not reflect any "hands on" physical examination by Respondent of Laine on any of the eight office visits. The greater weight of the expert testimony is that a minimal physical examination for a new patient with unverified complaints should entail a complete hands-on physical which palpates the head, eyes, ears, nose, throat, neck, chest, abdomen, and the extremities and joints, listening to the heart and lungs and examining the skin, plus a rectal examination. If only joint diseased arthritis, or rheumatoid arthritis were suspected or being investigated for treatment, a minimal physical examination should emphasize evaluating all joints (including peripheral joints) by palpation, determining the range of motion of affected joints, listening to the heart and lungs, taking blood pressure, and evaluating length and duration of symptoms. According to physicians board- certified or with a majority of their practices in rheumatology or internal medicine, it is particularly important in joint disease cases for the physician to feel the joint to determine which element thereof is swollen and to see if it is warm to the touch i.e. inflamed. Respondent admits his initial physical examination of Laine was merely observation of Laine's movements and his general ambulatory motion with his clothes on, examination of tophi in his ears, and listening to his heart and lungs. Respondent is vague about whether he observed Laine's hands. Respondent's type of initial physical examination, if it can be called that, and lack of follow-up examinations fall short of the level of care, skill, and treatment which is recognized by a reasonably prudent similar osteopathic physician as acceptable under similar conditions and circumstances. On May 27, 1983 Laine also went to see Jeffrey Erlich, M.D. He was in pain and getting no relief from Respondent. On that date Dr. Erlich took a history from Laine, performed a complete "hands on" physical examination, reviewed laboratory data provided him by Laine from Respondent and tentatively diagnosed Laine as having rheumatoid arthritis. Laine's condition was such that, at formal hearing, Dr. Erlich characterized Laine as "the second sickest rheumatoid arthritis patient" he had seen. Because of the severity of Laine's condition Dr. Erlich began Laine on oral predisone which is the conservative treatment of choice among the majority of medical physicians and osteopathic physicians for the treatment of rheumatoid arthritis. Laine was subsequently hospitalized for what may have been side effects of the predisone itself or aggravation of a pre-existing ulcer by the predisone. From this hospitalization, Respondent desires that the inference be drawn that Dr. Erlich was less close to prevailing standards of treatment than was Respondent because Erlich's prescription for predisone constituted an error of Erlich based on failed physical examination and history-taking, which error Respondent knowingly avoided by electing chelation therapy over the predisone treatment. Respondent's argument is not persuasive, and that leap of the imagination cannot be made upon the credible competent substantial evidence in the record. Faulty judgment calls of Dr. Erlich, even if any existed, are non-issues advanced by Respondent to draw attention from relevant and material issues. Further, while in the hospital, Laine was seen by a rheumatologist and a gastroenterologist who essentially confirmed Erlich's diagnosis of rheumatoid arthritis. Laine has since been administered several types of treatment for rheumatoid arthritis, including but not limited to D-Penicillamine, by both Erlich and the rheumatologist without much success, but Laine continues to tolerate predisone and to receive some pain relief therefrom. In light of the foregoing, it is found that Laine had rheumatoid arthritis which Respondent failed to diagnose principally because of Respondent's persistent reliance on the previous hair analysis and his failure to use "hands-on" physical examination contrary to the prevailing level of care, skill and treatment which is recognized by a reasonably prudent similar osteopathic physician as acceptable under similar conditions and circumstances. Respondent's reliance on hair analysis performed by a non-physician was misplaced and did not conform to the practice of medicine with that level of care, skill and treatment which is recognized by a reasonably prudent osteopathic physician under similar facts and circumstances. Not only is the greater weight of all credible expert evidence that hair analysis has little or no clinical value in diagnosing elevated copper levels or anything else because hair analysis indicates not only endogenous (internal or ingested) but also exogenous (external) sources of copper, but Respondent's own testimony further reveals that he merely assumed that the hair sample had been properly taken from the nape of Laine's neck and properly washed prior to testing. In making this finding of fact, the undersigned has not overlooked the testimony of Respondent's expert, Dr. Garry Gordon, who considers hair analysis to be a valuable diagnostic tool when laboratories meet all protocols. However, even Dr. Gordon admits that hair analysis is only relied on by a "distinct clear cut minority" nationwide; it is not required by the American Academy of Preventics; and the particular hair analysis of Laine in this case would probably show his most recent exogenous exposure to the copper boat hull. Respondent is a member of the American Academy of Medical Preventics and considers himself a holistic practitioner and an expert in the use of chelation therapy for prevention and cure of disease. /1 He administers chelation therapy to an average of 32 persons per week for one ailment or another. The American Academy of Medical Preventics is a group with a nationwide membership of 500-1000; of whom perhaps 100 are certified physicians. A protocol of this group requires extensive testing to verify the presence of various diseases, commends the least invasive approaches to testing and treatment, and favors chelation therapy for a number of ailments as well as hair analysis as a testing device. According to Respondents the D.M.S.O. was administered for the purpose of aiding the cell permeability of the vitamin C and later to aid the cell permeability of the E.D.T.A., E.D.T.A. was administered one time for the purpose of treating rheumatoid arthritis; the Phillpott's formula (primarily vitamin C) was for chelation of copper allergies and improving nutrition; and sulfur cyl was for inflammed joints. This treatment conforms to the American Academy of Preventics' protocol. It is stipulated by the parties that Respondent did not use D.M.S.O. as a treatment or cure for copper poisoning or as a treatment or cure for rheumatoid arthritis. (Pre-Hearing Stipulation paragraphs 33 and 34; H.O. Exhibit 2). Expert testimony was permitted to be elicited from Lloyd D. Gladding, D.O., Jeffrey Erlich M.D., Mark Montgomery, Ph.D., Wilbur Blechman, M.D., Garry Gordon, M.D., and Stanley Jacobs, M.D. Respondent objected to any testimony by Petitioner's witnesses, Dr. Gladding, D.O. (the only Florida licensed osteopathic physician other than Respondent to testify), Jeffrey Erlich, M.D., Mark Montgomery, Ph.D. in toxicology and instructor of both medical and osteopathic physicians, and Wilbur Blechman, M.D. because they were not "similar health care providers" in that none were physicians specializing in holistic and preventive medicine upon grounds that only reasonably prudent similar physicians may properly evaluate Respondent's performance. Dr. Blechman's testimony by deposition was further objected to by Respondent upon the ground that a medical physician may not testify to the statutory standard required of a "reasonably prudent similar osteopathic physician as acceptable under similar conditions and circumstances" as specified in Section 459.015(1)(t) F.S. This position was not consistent with Respondent's relying heavily on the testimony of Dr. Jacob, also a medical physician (M.D.) or Dr. Gordon, trained as an osteopath but accredited through a merger of schools as an M.D. Upon authority of Wright v. Schulte 441 So.2d 660 (Fla. 2d DCA 1983) 2/ upon the definition of "physician" contained in Section 459.0514(1) embracing both medical physicians and osteopathic physicians, upon the statutory language contained in Section 459.015(1)(t), specifying "The board shall give great weight to the provisions of Section 768.45 when enforcing this paragraph," and upon each witness' specialized education, training, and experience as evident from the records the undersigned overruled Respondent's objections and qualified the witnesses as experts pursuant to their respective qualifications. This ruling is also in accord with the history of Chapter 21R F.A.C., of which judicial notice has been taken, and which shows holistic and preventive medicine has never been recognized as a sub-speciality by the Board of Osteopathic Medical Examiners. This evidentiary ruling is here reaffirmed and reiterated as clarification of the weight and credibility of the experts' opinions accepted, relied upon, or rejected in this recommended order. The Food and Drug Administration (F.D.A.) is the federal agency charged with the enforcement of the federal Food and Drug Acts which includes the regulation of the manufacture and distribution of drug products. As part of its regulatory powers, the F.D.A. approves or disapproves drugs for human consumption. It does not approve or disapprove uses or treatments of drugs. Once the drug has been approved as a prescriptive agent, physicians are not limited by the F.D.A. in their utilization of approved drugs to the specific indications set forth in the F.D.A. package inserts. D.M.S.O. has been approved for human consumption. The package insert for D.M.S.O. as reported in the Physician's Desk Reference (PDR), a standard reference used by practicing physicians, recognizes it as indicated for treatment of the condition of interstitial cystitis only, a condition Laine did not have. E.D.T.A. has also been approved by the F.D.A. for human consumption. Its package insert as reported in PDR recognizes it as indicated for treatment of the conditions of digitalis toxicity, hypercalcemia, lead, and other heavy metal toxicities. The undersigned has considered the testimony of all the experts qualified in this case subject to differing weight and credibility considerations of their education, training, and experience. The definition of "experimental treatment" as that type of treatment which has not been shown to be effective or safe under clinical studies conducted after F.D.A. approval of the drug involved is accepted. With some minor variation of choice of words, that is the definition advanced by Dr. Gladding, D.O., Dr. Blechman, M.D. and by toxicologist Mark Montgomery, even though clinical tests also precede F.D.A. approval. D.M.S.O. and E.D.T.A. in the quantities and treatments used by Respondent are experimental and not approved or recognized as acceptable for treatment of either copper poisoning or rheumatoid arthritis by a respectable minority of the medical profession. The opinions of the Florida physicians board certified or with a majority of their practices in rheumatology or internal medicine and of Mark Montgomery, who teaches both medical physicians and osteopathic physicians the physical and physiological operation of various drugs, are considered more credible on this issue than that of Dr. Gordon, drafter of the American Academy of Preventics' protocol using E.D.T.A. and D.M.S.O. together in chelation. Dr. Gordon admits that in many ways all D.M.S.O. and E.D.T.A. treatments are practiced only by members of the American Academy of Medical Preventics, which has not yet been recognized by the American Medical Association and which represents a minority of physicians nationwide. Even by the construction of the evidence most favorable to Respondent, that is, the testimony of Dr. Jacob, Respondent's expert in D.M.S.O., the small quantities of D.M.S.O. administered by Respondent in the course of eight treatments would not have been therepeutically effective in reducing the copper levels in Laine's body and would not have been therepeutically effective in treatment of rheumatoid arthritis. A stronger solution than that used by Respondent would have been necessary to have either a positive or negative effect upon Laine. Dr. Jacob does not use D.M.S.O. for chelation but when using it by intravenous injection requires a release be signed. Laine was not physically harmed by the treatments administered by Respondent. The most that can be said is that the Respondent's misdiagnosis and useless treatments delayed his obtaining appropriate treatment. There is no recognized cure for rheumatoid arthritis and it has been shown that any of the numerous treatments utilized for rheumatoid arthritis will work on some individuals while not working on others. The symptoms of rheumatoid arthritis may alleviate without any treatments or conversely may get progressively worse regardless of any treatment utilized or they may clear up for no apparent reason.
Recommendation That the Board of Osteopathic Medical Examiners enter a final order finding Respondent guilty of violations of Count I [sections 459.015(h) and 459.0154], Count III [Section 459.015(1)(t)], Count IV [Section 459.015(1)(u)], Count V [Section 459.015(1)(n)], and Count VI, (section 459.015(1)(1)], suspending Respondent's license for a total period of one year therefor, and dismissing Count II [Section 459.015(1)(o)] with prejudice and dismissing Counts VII and VIII without prejudice. DONE and ORDERED this 14th day of May, 1986, in Tallahassee, Florida. ELLA JANE P. DAVIS Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 14th day of May, 1986.
Findings Of Fact Respondent, Leon L. Shore, was at all times material hereto a licensed osteopathic physician in the State of Florida, having been issued license number OS 0001600. On or about December 19, 1985, respondent presented to Harvey Sogoloff a pharmacist licensed in the State of Florida, a prescription to be filled. The subject prescription was written by respondent, and prescribed Percodan for himself. Mr. Sogaloff duly filled the subject prescription. Percodan, whose active ingredient is Oxicodone Hydrochloride, a salt of oxicode, is a Schedule II narcotic drug, as defined by Section 893.03(2)(a), Florida Statutes (1985). At the time of the prescription was written, respondent maintained his primary place of practice at 4801 South University Drive, Davie, Florida. During the first week of September, 1986, respondent closed his practice at that location without notice to petitioner, and did not thereafter practice for several months. In January, 1987, respondent resumed his practice at a new location, without notice to petitioner. Respondent asserts, however, that 2-3 weeks after commencing such practice, he instructed one of the medical directors at the center to notify petitioner of his new address. There was no proof that such notice was given, but following the commencement of this case, respondent did notify the petitioner of his new address, and no untoward consequences were shown to have resulted from such delay.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that a final order be entered placing respondent on probation for a period of one (1) year subject to such conditions as the board may specify, and imposing an administrative fine against respondent in the sum of $1,000. DONE AND ORDERED this 21st day of January, 1988, at Tallahassee, Florida. WILLIAM J. KENDRICK Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 21st day of January, 1988. APPENDIX Petitioner's proposed findings of fact are addressed as follows: Addressed in paragraph 2. & 8. Addressed in paragraphs 4 and 5. & 4. Addressed in paragraphs 2 and 3. 5-7 & 9. Rejected as not a finding of fact, or subordinate. Respondent's proposed findings of fact are addressed as follows: Not necessary to result reached. Not necessary to result reached. 3-9 & 12. Rejected as not a finding of fact, subordinate, or contrary to the result reached. 10 & 11. Addressed in paragraphs 4 and 5. COPIES FURNISHED: David G. Vinikoor, Esquire DAVID G. VINIKOOR, P.A. 420 S. E. Twelfth Street Fort Lauderdale, Florida 33316 Derk A. Young, Esquire 320 Southeast 9th Street Fort Lauderdale, Florida 33316 Mr. Rod Presnell Executive Director Osteopathic Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399 William O'Neil General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
