Findings Of Fact At all times relevant hereto Lawrence D. Urban was a licensed osteopathic physician in Florida having been issued license number OS 001232. From January 1983 through at least March 17, 1984, Respondent maintained offices in Clearwater and Zephyrhills. He practiced in the Clearwater office on Monday, Wednesday and Friday of each week and in the Zephyrhills office on Tuesday, Thursday and Saturday. Respondent employed Wendell Bloom to work in the Zephyrhills office as a business manager and assistant to Respondent. Bloom had no medically related license such as physician's assistant, nurse, technician, etc. As an assistant to Respondent, Bloom drew blood, performed vascular analyses, mixed IV solutions, and administered IV solutions. He worked at the Zephyrhills office Monday through Friday. Bloom had standing orders from Respondent that if a new patient came in Bloom would draw a blood sample, send it to the lab for analysis and make an appointment for the patient to see Respondent when the results of the blood analysis was received. Respondent described his practice in Zephyrhills as holistic, involving nutrition, chelation, and cancer therapy using laetril. Chelation treatment involves the intravenous injections of solutions containing EDTA (Ethylenadiaminetetracetic acid), vitamins, including B12, B complex and C, and the minerals, calcium and magnesium. On many occasions Bloom commenced IV chelation injections containing EDTA before Respondent arrived at the office and completed some of these after Respondent had left the office. On at least five (5) occasions Bloom injected patients with IV solutions containing EDTA without Respondent being present any time during the procedure. Drawing blood without a doctor present in the office constitutes the practice of medicine. Injecting IV solutions in patients constitutes the practice of medicine without a doctor present. In the Zephyrhills office Respondent referred to Bloom as Dr. Bloom in the presence of patients. No sign or disclaimer was posted in the office that Bloom had no prior medical training and was not licensed in any medically related health professional field in Florida. Respondent knew that patients might believe Bloom to be a medical doctor. In administering an IV solution to a patient there is always a danger of an allergic reaction or an anaphylactic reaction, even if a patient has previously tolerated the treatment. Respondent acknowledged that serious side affects would result to a patient receiving an IV solution containing EDTA if the patient suffered kidney failure. Bloom also operated the vascular analyzer machine in the office. As described by Bloom, by attaching clips from the machine to the fingers and toes the machine will tell you if there is any kind of clotting or obstruction any place within the cardiovascular system. Further, by putting transmission gel on the clip and holding it over an artery, transmissions from the clip with the return echo is transformed onto a chart which will denote the elasticity of the artery. This machine is not universally accepted in the medical profession. By Final Order entered August 26, 1983 (Exhibit 1) the Florida Board of Osteopathic Medical Examiners found Respondent guilty of filing false reports, fee splitting, and abetting an unlicensed person to practice osteopathic medicine. He was sentenced to a reprimand, placed on probation for six (6) months and directed to report to the Board at the end of the probationary period. If, at this time, Respondent's report on the status of his practice satisfies the Board that the financial aspects of his practice is in accordance with the law, the reprimand will be withdrawn. Terms and conditions of the probation were not delineated. Respondent appeared before the Board at its March 17, 1984 meeting. After Respondent reported that the financial aspects of his practice were poor, but in conformity with the law, one of the Board members inquired if Respondent was working with any non-osteopathic physicians in his practice, which was one of the accusations for which he was reprimanded and placed on probation. At this point Respondent told the Board that he had a helper who was a "non- anything" who was drawing blood, doing vascular analyses of patients, giving IVs to patients undergoing chelation therapy and whatever Respondent told him to do. (Exhibit 2) After hearing these disturbing facts the Board voted to extend the Respondent's probation while an investigation of his practice was conducted. The charges considered at this hearing were those resulting from that investigation.
The Issue The issue presented for decision herein is whether or not Respondent has engaged in conduct, more particularly set forth in the Administrative Complaint filed herein, signed April 10, 1986, violative of Chapter 459, Florida Statutes.
Findings Of Fact Based upon my observation of the witnesses and their demeanor while testifying, documentary evidence received and the entire record compiled herein, I hereby make the following relevant factual findings. Respondent, Donald J. Weiss, D.O., during times material herein, was licensed as an osteopathic physician in Florida and has been issued license number OS 0003459. The investigative report of Petitioner's investigator Mel Waxman, medical records and a consultant's report of Dr. Ralph Birzon, D.O., were received into evidence without objection except for certain unspecified prescriptions (by Respondent). During the time period 1980 through 1985, Respondent admitted to having treated patients R.N., H.M. and C.B. or C.P. Respondent admitted to the treatment of the above- referred patients with specific dates relating to prescriptions of Schedule II drugs for patients R.N. and H.M. (Request for Admissions dated June 2, 1986). A review of the medical records for patients R.N., H.M. and C.B. or C.P. reveals that Respondent failed to maintain appropriate medical records justifying his course of medical treatment for such patients. As example, during the period January 1984 and June 19, 1985, Respondent prescribed 1,970 4 mg. Dilaudid and 380 Seconal 100 mg. capsules for patient R.N. Also, during the same time period, Respondent prescribed 2,665 4 mg. tablets of Dilaudid for patient H.M. (Responses to Request for Admissions dated June 2, 1986). Respondent failed to take adequate physical exams, laboratory reports or other medical histories to justify the quantity of controlled substances prescribed for patients R.N and H.M. In his treatment of patient R.N., H.M. and C.B., each patient was addicted to the medication Dilaudid and Seconal, both Schedule II controlled substances as defined in Sections 893.03(2)(a) and (c), Florida Statutes. Respondent's treatment of patients R.N., H.M. and C.B. by prescribing Dilaudid, Seconal and Valium (also a Schedule II controlled substance) was not in their best interest as addicts. Based upon a review of the medical records for patients R.N., H.M. and C.B. or C.P., Respondent's prescriptions for Dilaudid, Seconal and Valium were excessive, inappropriate and unacceptable for an osteopathic physician. Respondent's treatment for patients R.N., H.M and C.B. or C.P. fell below the level of care, skill and treatment as recognized by a reasonable prudent similar osteopathic physician as being acceptable under similar conditions and circumstances. (Testimony of Ralph Birzon, D.O., TR 41-46). An examination of the Physician's Desk Reference (PDR) reveals that Respondent, by prescribing Dilaudid and Seconal to patients R.N. and H.M. was inappropriate, and when taken together, exacerbated those patient's medical problems. Additionally, a review of the PDR indicates that Dilaudid cannot be safely prescribed for long periods of time. A long period of time is, based on the reference, a period in excess of three months. Respondent admits that he made a mistake in his treatment of the above-referred patients by prescribing Schedule II controlled substances. Respondent considered that he was "duped" and offered that this was his first contact with drug addicts. Respondent prays that his license not be revoked or suspended and offered to accept any lesser ordered penalty.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, RECOMMENDED THAT: Respondent's license be suspended for a period of six (6) months; Following the period of suspension, Respondent be placed on probation for a similar period of six (6) months; During the probationary period, Respondent be required to successfully complete eighty (80) hours of continuing education related to the physician and proper substance abuse prescribing procedures. RECOMMENDED this 18th day of December, 1986, in Tallahassee, Florida. JAMES E. BRADWELL 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 18th day of December, 1986. COPIES FURNISHED: Preston T. Everett, Jr., Esquire Fred Roche, Secretary Department of Professional Department of Professional Regulation Regulation 130 North Monroe Street 130 North Monroe Street Tallahassee, Florida 32301 Tallahassee, Florida 32301 Donald J. Weiss, D.O. Wings Benton, Esquire 145 River North Circle General Counsel Atlanta, Georgia 30328 Department of Professional Regulation Rod Presnell, Executive Director Board of Osteopathic Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301 130 North Monroe Street Tallahassee, Florida 32301 =================================================================
Findings Of Fact The following Findings of Fact are based upon the testimony and documentary evidence presented at hearing, the demeanor and credibility of the witnesses, and on the entire record of this proceeding. Petitioner is the state agency charged with regulating the practice of osteopathic medicine pursuant to section 20.43, and chapters 456 and 459, Florida Statutes. At all times material to these proceedings, Respondent was a licensed osteopathic physician within the State of Florida, having been issued license number OS 8729. Respondent's address of record at the time of filing the Administrative Complaint was 11950 County Road 101, Suites 101, 102, and 103, The Villages, Florida 32162. Respondent's current address of record is 13767 U.S. Highway 441, Lady Lake, Florida 32159. Respondent currently holds no board certification in any specialty area, and did not complete any residency other than in emergency medicine. Respondent attended Michigan State University, College of Osteopathic Medicine. In 2002, he began full-time practice as an emergency room physician at Munroe Regional Medical Center in Ocala, Florida. He worked as an emergency room physician until he opened Exceptional Urgent Care Center (“EUCC”). At all times material to this complaint, Respondent owned and operated EUCC. Treatment Provided to Patient J.K. On March 15, 2018, J.K., along with his wife, presented to EUCC with complaints of a sore throat and fever. This was the first of two visits to the clinic. J.K. reported his medications as Amlodipine, Warfarin, Tamsulosin, and Dofetilide (unless otherwise indicated, hereinafter referred to by its trade name "Tikosyn"). J.K. was prescribed these medications by his cardiologist at the William S. Middleton Memorial Veterans Hospital (“V.A. Hospital”) in Wisconsin, his home state. Relevant to this matter, Tikosyn helps patients maintain a normal heartbeat rhythm. Tikosyn was prescribed to keep J.K.'s heart in rhythm as he had atrial fibrillation. J.K. was treated by a nurse practitioner, who ordered a chest x-ray and a flu swab. The flu swab returned negative, and the chest x-ray showed no focal pneumonia. J.K. was prescribed Tamiflu and Naproxen. J.K. elected not to fill the Tamiflu due to the “expensive cost.” Respondent was not involved in J.K.'s treatment on this date. On March 16, 2018, J.K. and his wife K.K. returned to EUCC as J.K.’s symptoms had not improved. On this visit, J.K. saw Dr. Im. Dr. Im evaluated J.K. and ordered two tests. Dr. Im ordered a Prothrombin Time International Normalized Ration ("PT INR") test to determine J.K.'s coagulation and he ordered a CT scan of the chest. The PT INR results were within the therapeutic range. The CT scan showed shattered ground- glass opacification in the posterior right lower lobe and the medial left upper lobe. The CT scan findings were interpreted as "non-specific, may represent hypoventilatory change or an infectious inflammatory process (acute or chronic).” Respondent advised J.K. and K.K. that the CT scan appeared to show the start of pneumonia, and he was going to prescribe three medications: Levaquin 750 mg, Prednisone 20 mg, and Zyrtec 10 mg. K.K. testified that she asked Respondent if the Levaquin, Prednisone, or Zyrtec were contraindicated with any of J.K.'s current prescriptions, specifically Tikosyn. K.K recalls that Respondent replied that he was not familiar with Dofetilide (Tikosyn), and advised them to check with the pharmacist to see if there were any contraindications. Although Respondent initially advised J.K. and K.K. that he was not familiar with Tikosyn, Respondent testified that he advised J.K. and K.K. of the possible interactions between Levaquin and Tikosyn and told her that the interaction was very rare. He testified that he advised J.K. and K.K. that the pharmacist is a safety net, and the pharmacist would call him to discuss the prescriptions if he missed anything. K.K. credibly testified that Respondent did not counsel J.K. or K.K. on any risks regarding the medications Dr. Im prescribed or provide them with any alternatives during the visit on March 16, 2018. J.K. and K.K. left EUCC and went to Publix to fill the prescriptions. K.K. asked the pharmacist if any medications would interfere with any of J.K.'s prescribed medications. Upon advice of the pharmacist that Levaquin was contraindicated with Tikosyn, K.K. declined to fill the prescription for Levaquin. On behalf of J.K., K.K. then called EUCC and asked for a different antibiotic that would not interact with Tikosyn. However, she was instructed to contact J.K.'s cardiologist. K.K. then contacted the cardiology staff of the V.A. Hospital in Wisconsin, who instructed K.K. to follow the advice of the pharmacist and (tell J.K.) not to take the Levaquin. K.K. called EUCC a second time to confirm whether J.K. had an infection and she was told that J.K. did not have an infection. Respondent recalls that he had a personal conversation with K.K. during a courtesy telephone call placed the next day (March 17, 2018). Respondent testified that during that call, he explained Levaquin was the drug of choice, other medications would not cover J.K.'s pneumonia, the potential interactions were very rare, and J.K. needed to take the Levaquin. By his own admission and his medical records, Respondent did not provide J.K. or K.K. with any specific alternative antibiotics and insisted that J.K. needed to take the Levaquin. K.K. disputes that Dr. Im spoke with her or J.K. at any point after the March 16, 2018, visit. She clearly recalled that she spoke with a woman each time she spoke with staff at Dr. Im’s office. Overall, J.K. and K.K. clearly and convincingly testified that Respondent never advised them of the risks of using Levaquin with Tikosyn or provided any alternatives to the Levaquin. Expert Testimony Petitioner offered the testimony of Dr. Anthony Davis, who testified as an expert. Dr. Davis has been licensed as an osteopathic physician in Florida since 1995. Dr. Davis attended Kirksville College of Osteopathic Medicine and completed an internship in family practice. He has been board certified in family medicine by the American Board of Osteopathic Family Physicians since 2001, and board certified in emergency medicine by the American Association of Physician Specialists since July 2003. He is also affiliated with professional organizations including the American College of Family Practice and Florida Osteopathic Medical Association. Dr. Davis was accepted as an expert in emergency and family medicine. Dr. Davis relied upon his work experience, his training, and his review of the medical records for J.K. to render his opinion regarding the standard of care related to treating J.K. The standard of care requires an osteopathic physician treating a patient similar to J.K. to: (1) provide and document their justification for why Levaquin was the appropriate drug of choice; (2) note the patient’s acknowledgment that there are interactions with Tikosyn; (3) ensure the patient understands the risks and benefits of combining Tikosyn and Levaquin; (4) explain to the patient that there are limited alternatives to Levaquin; and (5) provide the reason for prescribing a potentially dangerous drug. Levaquin is a medication that comes with a black box warning that requires physicians to counsel patients on the risks associated. When a drug is designated as contraindicated and has a category X for interaction, the standard of care requires that the physician clearly explains to the patient why they are using the drug and defend how it is going to be safe. Tr., p. 70. Dr. Davis opined there were multiple treatment options available for J.K., such as supportive care or an antibiotic with a lower risk of interaction with J.K.'s existing medication. Moreover, Dr. Davis testified that there were safer alternatives to Levaquin that would effectively treat pneumonia, such as doxycycline, if J.K. actually had pneumonia and an antibiotic was necessary. Respondent provided literature from the Infectious Diseases Society of America related to community-acquired pneumonia in an attempt to prove that X-Ray or other imaging techniques are required for the diagnosis of pneumonia and to support his claim that Levaquin was the drug of choice for J.K. However, Dr. Davis credibly pointed out that the article, published in 2007, is no longer accurate.
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 as follows: Finding that John Joseph Im, D.O., violated section 459.015(1)(x), by committing medical malpractice, as defined in section 456.50, as alleged in the Administrative Complaint; Issue a letter of concern against Respondent’s license to practice osteopathic medicine; Requiring completion of a prescribing practices course; and Imposing an administrative fine of $2,500. DONE AND ENTERED this 16th day of December, 2019, in Tallahassee, Leon County, Florida. S YOLONDA Y. GREEN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 16th day of December, 2019.
Findings Of Fact Petitioner Marshall J. Barker filed an application for licensure by endorsement with Respondent Department of Professional Regulation, Board of Medical Examiners on July 27, 1981. The application reflected that he sought licensure on the basis of certification by licensure examination of the Federation of State Medical Boards of the United States, Inc. (FLEX). The application further showed that Petitioner had obtained the degree of Doctor of Osteopathic Medicine from the West Virginia School of Osteopathic Medicine on May 30, 1980, and that he had interned at various hospitals in Pensacola under the Pensacola Educational Program from July 1, 1980 through June 30, 1981. The internship was one approved by the American Medical Association. Petitioner was certified by licensure examination of the Federation of State Medical Boards of the United States, Inc. on July 27, 1981. He was licensed to practice medicine in the State of North Carolina in June, 1981, and in the State of Alabama on July 16, 1981. (Respondent's Exhibit 5) Petitioner personally appeared before the Respondent Board of Medical Examiners on September 13, 1981 at its meeting when his application was considered. In a written submission, Petitioner pointed out to the Board that he could not be licensed in Florida as an osteopath because he had engaged in a medical internship rather than one in osteopathic medicine. He urged, however, that he be licensed to practice medicine because Section 458.311, Florida Statutes, had been changed in 1979 to permit recognition of graduation from a medical school or college recognized and approved by an accrediting agency recognized by the United States Office of Education, and that the West Virginia School of Osteopathic Medicine is recognized by the American Osteopathic Association and by the Council on Post-Secondary Accreditation under the U.S. Department of Education. He also sought to amend his application to be one for licensure by examination rather than by endorsement. (Respondent's Exhibit 5). By Order, dated October 2, 1981, Respondent denied Petitioner's application for licensure by endorsement on the ground that he is not specialty board certified, or a graduate of a medical school or college recognized and approved by an accrediting agency recognized by the United States Office of Education. It was therefore concluded by the Board that he had not met the statutory requirements for licensure by endorsement pursuant to Sections 458.313 and 458.311(4), Florida Statutes. The Petitioner was informed in the Order that he could petition for a hearing under Sections 120.57 and 120.60, Florida Statutes. Petitioner did not request an administrative hearing, but appealed the decision of the Board to the First District Court of Appeal. (Respondent's Exhibits 4-5) Prior to 1979, the Medical Practice Act required an applicant for licensure to be a graduate of a medical school or college approved by the Board of Medical Examiners. (Sections 458.05 and 458.08, F.S.) The Board had implemented the statute by promulgation of Rule 21M-1.06, Florida Administrative Code, which read as follows: 21M-1.06 Approved Medical Schools - An approved medical school or college is one located within the United States or Canada, maintaining a standard and reputability as that adopted by the Council on Medical Education and Hospitals of the American Medical Association and the Association of American Medical Colleges. The rule was repealed in 1980 as a result of the repeal of Chapter 458, Florida Statutes (1978), and the enactment of Chapters 79-36 and 79-302 Laws of Florida, which required new rules regarding requirements for admission to the practice of medicine. New rules on the accreditation of medical schools have not yet been adopted by the Board. However, current Board policy recognizes those medical schools or colleges approved by the Liaison Committee on Medical Education (LCME) of the Council on Medical Education of the American Medical Association. (Testimony of Faircloth, Respondent's Exhibits 1-2) The United States Department of Education recognizes separate accrediting agencies for "medicine" and "osteopathic medicine" as reliable authorities concerning the quality of education or training offered by educational institutions or programs. In its publication "Accredited Postsecondary Institutions and Programs," the Department of Education recognizes the Liaison Committee on Medical Education of the Council on Medical Education of the American Medical Association and the Executive Council of the Association of American Medical Colleges as the accrediting agency for medicine, and the American Osteopathic Association as the accrediting agency for osteopathic medicine. (Respondent's Exhibit 3) No evidence was presented by the parties concerning the legislative history of subsection 458.311(1)(b), Florida Statutes. The West Virginia School of Osteopathic Medicine is not recognized by the American Medical Association as a school offering an accredited program leading to an MD degree. (Respondent's Exhibit 6)
Recommendation It is recommended that the Board of Medical Examiners deny the application of Petitioner, Marshall J. Barker. DONE and ENTERED this 1st day of December, 1982, in Tallahassee, Florida. THOMAS C. OLDHAM 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 1st day of December, 1982. COPIES FURNISHED: Bruce A. McDonald, Esquire Emmanuel, Sheppard & Condon Post Office Drawer 1271 Pensacola, Florida 32596 Chris D. Rolle, Esquire Department of Legal Affairs The Capitol, Suite 1602 Tallahassee, Florida 32301 Samuel Shorstein, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Dorothy Faircloth Executive Director Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301
The Issue At issue in this proceeding is whether Respondent committed the offense set forth in the Administrative Complaint and, if so, what penalty should be imposed.
Findings Of Fact The Department of Health, Division of Medical Quality Assurance, Board of Osteopathic Medicine (Department), is a state agency charged with the duty and responsibility for regulating the practice of osteopathic medicine pursuant to Sections 20.43 and Chapters 455 and 459, Florida Statutes. Respondent, John E. Gdowik, is, and was at all times material hereto, a licensed osteopathic physician in the State of Florida, having been issued license number OS 0002696. Moreover, during all such periods, Respondent was registered with the Department, pursuant to Section 465.0276, Florida Statutes, as a dispensing physician and thereby accorded the privilege of dispensing medicinal drugs from his office for compensation. At the times pertinent to this case, Respondent maintained his office at what was commonly known as 6136 Johnson Street, Hollywood, Florida; however, he had removed the street numbers from the building and chose to refer to his office location as the southeast corner of 62nd Avenue and Johnson Street. Respondent also refused mail delivery at his office, and directed, consistent with a sign posted on the premises discussed infra, that all mail be sent to him at General Delivery, Hollywood, Florida. At or about 11:30 a.m., April 4, 1997, Anthony Spina, an agency investigator, went to Respondent's office for the purpose of conducting a routine inspection pursuant to Section 465.0276(3), Florida Statutes, to ascertain whether Respondent was in compliance with all statutes and rules pertinent to his dispensing practice. At the time, the office was closed and Mr. Spina was unable to gain entry; however, he did take note of two eight-and one-half by eleven-inch signs posted at the entrance. One sign read, as follows: NOTICE NO TRESPASSING ALL GOVERNMENTAL OFFICIALS KEEP OUT POSTED The other sign read, as follows: NOTICE John Edwin Gdowik, a Good and Lawful Christian man and Osteopathic Physician, teaches and advises patrons on matters of health. All mail should be sent to John Edwin Gdowik General Delivery Hollywood, Florida Following Mr. Spina's return to his own office, he located a listing in the local white pages telephone directory for Respondent at the subject address, and on April 7, 1997, Mr. Spina engaged in a brief telephone conversation with the Respondent. At that time, Mr. Spina informed Respondent that he was proposing to conduct an annual inspection, based on the privilege accorded Respondent as a dispensing physician. In response, Respondent told Mr. Spina to send him a letter to such effect (place his request in writing), and referred Mr. Spina to the sign directing that all mail be sent to Respondent at General Delivery, Hollywood, Florida. Respondent did not, at anytime during the course of such conversation refuse or otherwise imply he would not allow an inspection of his office.1 Mr. Spina did not, however, submit a letter to Respondent or take any further action (of which Respondent would have been aware) to inspect Respondent's office. Following his conversation with Respondent, Mr. Spina apparently notified Hugh Fitzpatrick, his supervisor, regarding his efforts to inspect Respondent's office and the substance of his conversation with Respondent. In turn, Mr. Fitzpatrick informed the agency's legal office, and they requested a written report from Mr. Spina. By memorandum of April 14, 1997 (Petitioner's Exhibit 11), Mr. Spina provided the report requested by the legal office. That report noted the information discussed in paragraphs 4 and 5, supra, and further noted that "[o]n 4/10/97, this investigator . . . returned to the subject's office. The office was closed. We obtained three polaroid photographs [of the signs heretofore discussed]." Mr. Spina's memorandum enclosed photocopies of the photographs.2 Based on Mr. Spina's report, the agency instituted an investigation to resolve whether there was probable cause to believe that Respondent had violated Subsection 459.015(1)(g), Florida Statutes, by "failure to allow inspection by agency for a dispensing physician." (Petitioner's Exhibits 10 and 16A.) Consistent with Subsection 455.225(1)(b), Florida Statutes, by letter of June 4, 1997, Mr. Fitzpatrick, on behalf of the agency, sought to advise Respondent of the pendency of the investigation. The agency's form letter provided, as follows: Dear: Dr. Gdowik: This letter is notification that there is a pending investigation regarding your license to practice in the State of Florida. The investigation is base[d] upon the enclosed document which was determined to be legally sufficient for investigation pursuant to section 455.225, Florida Statutes. You are invited to submit a written response or you may call me to schedule an interview within 45 days of receiving this letter. Your response will be made part of the file and will be considered by the agency and probable cause panel in determining whether a formal administrative complaint should be filed in this matter. In addition, for consideration by the probable cause panel, please provide a copy of your curriculum vitae and identify your specialty, if any. If you choose to send a response, please use the mailing address printed on the bottom of this letter and include the AHCA case number in any correspondence you may send concerning this matter. At this stage, the investigation is confidential. This means that the contents of this investigation cannot be disclosed to you or the general public, nor can it be disclosed to the public the fact that the attached documentation was received, unless probable cause is found or you submit a written waiver of confidentiality. You are not required to answer any questions or give any statement and you have the right to be represented by counsel. It is not possible to estimate how long it will take to complete this investigation because the circumstances of each investigation differ. Thank you for your cooperation and understanding in this matter. If you have any questions or wish to discuss this in greater detail, you may contact me at the telephone number listed at the bottom of this letter. The notification letter was addressed to Respondent at 6136 Johnson Street, Hollywood, Florida, and on June 11, 1997, was returned by the Post Office marked "Return to Sender." The agency took no further action regarding the matter until August 1, 1997, when Mr. Fitzpatrick telephoned Respondent's office regarding the investigation. At the time, Mr. Fitzpatrick spoke with the receptionist, who advised him that the Respondent was busy seeing patients, and she requested that the letter of June 4, 1997, be re-mailed to Respondent at General Delivery, Hollywood, Florida. Mr. Fitzpatrick persisted in his effort to speak with the Respondent, and told the receptionist to advise the Respondent that "if he doesn't call back within the hour, the case report in question will be sent forward." Respondent did not return Mr. Fitzpatrick's call; Mr. Fitzpatrick did not re-post the notification letter; and on August 1, 1997, Mr. Fitzpatrick completed his report and "sent [it] forward" to the legal office.3 (Petitioner's Exhibit 10.) The complaint, as well as the results of Mr. Fitzpatrick's investigation, was presented to the Probable Cause Panel for the Board of Osteopathic Medicine, and on November 12, 1997, the subject Administrative Complaint was issued which charged that Respondent violated the provisions of Subsection 459.015(1)(g), Florida Statutes, because he "failed to cooperate with . . . agency investigators in reference to an inspection of Respondent's dispensing practitioner facility."
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered which dismisses the Administrative Complaint. DONE AND ENTERED this 21st day of April, 1999, in Tallahassee, Leon County, Florida. WILLIAM J. KENDRICK 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 21st day of April, 1999.
The Issue The issue in this proceeding is whether the Respondent, Jules Jonas Dossick, D.O. violated statutes governing the practice of osteopathic medicine on the grounds alleged in the administrative complaint and if so, what disciplinary action is appropriate. Background and Procedural Matters This proceeding commenced when Petitioner filed its administrative complaint and Respondent timely requested a formal hearing. At the hearing Petitioner verbally amended its complaint by deleting all factual and legal allegations relating to sexual misconduct and violations of Section 459.015(1)(k) Florida Statutes. Petitioner presented evidence through three witnesses and four exhibits. Respondent testified on his own behalf and presented one exhibit. All exhibits were admitted without objection. Petitioner has submitted a proposed recommended order, which proposal has been considered and, in part, included in this order. A specific ruling on each proposed finding of fact is found in the appendix attached hereto. By pleadings dated May 23, 1986, Respondent has moved for a re- hearing and has objected to the Petitioner's proposed recommended order, both on the grounds that he has now retained counsel and should have the opportunity to have the case re-heard with the benefit of an attorney. Respondent had an attorney in an earlier part of this proceeding and discharged him by letter dated February 22, 1986. (see letter attached to motion to withdraw filed March 3, 1986). Approximately two months later the final hearing was held. Respondent had ample time to retain new counsel or ask for a continuance. He proceeded to hearing, aware of his rights and without protest. The record is void of any basis to consider such extraordinary relief.
Findings Of Fact Respondent, Dr. Dossick, is now and at all times relevant has been licensed as an osteopathic physician in Florida under license number OS 0000874. He practices at his clinic, North Miami Medical Center, located at 4805 East 4th Avenue in Hialeah, Florida. (T-10,11). The clinic is comprised of a reception room, a kitchen that is also used as an office, a bathroom near the reception area, a supply room, two examining rooms, and two additional rooms with a bathroom and shower at the rear of the clinic. Dr. Dossick lives at the clinic and keeps the additional rooms for his bedroom, for storage and for personal use. One of the additional rooms was used several years ago as a third examining room. (T-43, 44, 114-116). In January 1985, two investigators from the Department of Professional Regulation went to Respondent's Clinic for an inspection. They took pictures and spoke to Dr. Dossick. Three other individuals were at the clinic the day of the inspection: a man and woman in one examining room, and a woman in what the inspectors thought was an examining room, but was identified by Dr. Dossick as his personal use and storage room. (T-41, 49, 57, 64, 116). The investigators found the clinic in varying stages of filth and disarray. The reception room was old and worn, unclean, but with little sign of current use. The kitchen had dirty dishes and exposed garbage. The examining rooms were fairly neat but the medications on the countertops were old, dirty and, in some cases, expired. There was no garbage in the two examining rooms, but they did not appear clean. The third room, the former examining room (now used for storage and Dr. Dossick's personal living quarters) was a mess: clothing, mail and fast food containers were strewn about, cotton swabs were exposed and piled on a counter; syringes and medications were also exposed on the countertops. In this room the narcotics supply was stored in a locked cabinet. Two dogs were present in the clinic, one of which had patches of hair missing as if diseased. (T-46, 49, Petitioner's Exhibits #3 and #4) There was no evidence that patients had access to the kitchen, supply room or Dr. Dossick's bedroom. Patients occasionally go to the former examining room and wait there prior to seeing the doctor. Dr. Dossick keeps his own dog at the clinic and, even though he does not encourage them, his patients sometimes bring their animals to the clinic with them. Dr. Dossick admitted that he had trouble for a while keeping the place clean. The woman who worked for him injured her knee in a karate tournament and had surgery. While the admission of problems was candid, the excuse regarding the former cleaning worker was confused: the handwritten statement Dr. Dossick presented from Barbara O'Rourke suggested that her accident and subsequent surgery occurred in April and July 1 85, respectively; that is, several months after the DPR inspectors' visit. (T-64, 87-89, 105-106, 112-113). Linda Joyce Godfrey is a patient of Dr. Dossick. She is thirty-nine years old, was born with cerebral palsy, and around 1981 was diagnosed with multiple-sclerosis. She is crippled and walks unaided with considerable difficulty. She has undergone several operations and lengthy periods of hospitalization. She has been under the care of various physicians, including an orthopedist, several neurosurgeons, and another osteopathic physician. (T-66, 69) Ms. Godfrey began seeing Dr. Dossick after an extended hospitalization period. She picked him at random and asked for percodan, a controlled narcotic substance, generally prescribed for pain relief. He refused to give her the percodan and prescribed a non-narcotic medication instead. She continued seeing him and later he prescribed placidyl, percocet and percodan at various times to help her sleep and for the severe pain in her muscles and bones. He did not give her these medications until he obtained her hospital reports and talked with her regular physicians. (T-66,69,81) Ms. Godfrey admits that she was an addict. She claims that Dr. Dossick was initially unaware of this but later helped her get off the habit. On one occasion she went to his office in the state of apparent overdose. He called Hialeah Fire and Rescue and got her out of there. He told her not to come around anymore because he didn't go for drugs. She later went back and asked for help. The evidence is inconclusive as to whether Ms. Godfrey's episode was an overdose or a grand mal seizure. (T-69, 73-76, 80, 90-91). According to Ms. Godfrey, Dr. Dossick injected her with Demerol on only one occasion, around six weeks prior to the hearing, after her apartment was broken into and she was raped. (T-71, 72). The practice of osteopathic medicine encompasses all aspects of medicine commonly referred to as allopathic medicine, but also includes physiotherapy, manipulative therapy, nutrition: a holistic approach. (T-13,14). This characterization of the distinction between the professions is borne out in the statutory definitions of "practice of medicine" and "practice of osteopathic medicine": "Practice of osteopathic medicine" means the diagnosis, treatment, operation, or prescription for any human disease, pain, injury, deformity, or other physical or mental condition, which practice is based in part upon educational standards and requirements which emphasize the importance of the musculoskeletal structure and manipulative therapy in the maintenance and restoration of health. 1l. Except for the underlined verbiage the two definitions are the same. See Section 458.305(3) Florida Statutes, and Section 459.003(3) Florida Statutes. One of the rudiments of osteopathic medicine values the "laying of hands" as part of caring for a patient in a very kind and personal manner. Cleanliness of the person and the physical area surrounding the practitioner is essential to avoid transferring disease from one patient to another. (T-18,19) Animals should not be present in the clinic because of the potential for communicating disease to humans through fleas, flies or the animals. (T-18) Old, dirty drugs and syringes should be disposed of in such a manner as to avoid access and use. (T-19,20) The above standards were described in the competent, uncontroverted testimony of Petitioner's expert, Ralph Birzon, D.O. Those standards were violated by Dr. Dossick when he allowed dogs in the clinic, when he failed to properly dispose of old drugs and syringes, and when he failed to keep his clinic clean. Dr. Dossick does, however, treat his patients in a very kind and personal manner. Ms. Godfrey was called as Petitioner's witness. Her testimony was credible and touchingly candid, as also was Dr. Dossick's. Ms. Godfrey said Dr. Dossick helped her; he took pity on her; he is good to his patients and is a good man. She does not have the money to pay for his treatment or the prescriptions, so she sometimes files and answers the phone at the clinic. Dr. Dossick is the oldest physician in the area; he spends a lot of time with his patients and they depend on him. He regularly treats his patients without charge, or for a token fee. He also loans them money for prescriptions. He has treated some patients for 25-30 years. (T-81, 83, 93, 95-96, 103) Dr. Dossick has previously been suspended by the Board of Osteopathic Medical Examiners for six months because of allegations that he prescribed medication without performing an examination. He volunteered this fact. (T-97, 107-109) The violations occurred approximately ten years ago. See Board of Osteopathic Medical Examiners v Dossick DOAH #76-1814; Dossick v Florida State Board of Osteopathic Medical Examiners, 359 So. 2d 12 (Fla. 3rd DCA 1978). The clinic has been cleaned up since the investigators' visit and the dirty and outdated drugs have been discarded. (T- 88,104)
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.
