The Issue Whether Respondent violated Subsections 460.413(1)(ff) and 456.072(1)(u), and Section 460.412, Florida Statutes (2002),1 and, if so, what discipline should be imposed.
Findings Of Fact At all times material to this proceeding, Dr. Hether was a licensed chiropractic physician within the State of Florida, having been issued license number CH 2601 on or about April 16, 1977. Other than the instant Administrative Complaint, Dr. Hether has had no disciplinary action taken against his license. In April 2003, Dr. Hether had two chiropractic offices, one in Port Orange, Florida, and one in Deland, Florida. On or about April 8, 2003, C.B., a 29-year-old female, presented herself to Dr. Hether's office in Port Orange, Florida, in order to receive chiropractic treatment for injuries she sustained in an automobile accident. C.B. began receiving treatments in the Port Orange Office, but switched her appointments to the Deland office on or about May 8, 2003. The remainder of her treatments was given at the Deland office. Her treatments included chiropractic adjustments and massages. The chiropractic adjustments were performed by Dr. Hether and other physicians who worked for Dr. Hether; however, the majority of the chiropractic adjustments were performed by Dr. Hether. Until C.B.'s visit on June 11, 2003, all the massages had been performed by licensed massage therapists who worked for Dr. Hether. From on or about April 8, 2003, up to June 11, 2003, C.B. received various chiropractic treatments at Dr. Hether's offices without incident. On June 11, 2003, C.B. presented herself to Dr. Hether's office to receive her usual chiropractic treatment, including a massage. Dr. Hether, his son, and another male were in the office. Dr. Hether offered to perform the massage on C.B. because the regular massage therapist was not present, and C.B. accepted. C.B. went into the massage room, undressed to her underwear, and lay face down on the table with a sheet draped over her. Dr. Hether came into the massage room and began to massage C.B. Dr. Hether and C.B. were the only persons in the room during the massage. While C.B. was lying face down, Dr. Hether slipped his hands under C.B.'s underwear on the left side of her buttocks and then placed his hand under her underwear on the right side of her buttocks. At Dr. Hether's instruction, C.B. turned over onto her back. Dr. Hether placed his hands under C.B.'s breast area and rubbed upward towards her cleavage. Dr. Hether then slid his hand down C.B.'s body toward her vaginal area, grabbed a part of C.B.'s vaginal area, and began to make grunting noises as if he were getting sexual pleasure from the touching. While Dr. Hether was touching C.B.'s vaginal area, Chase Hether, Dr. Hether's son and office manager, knocked on the door to the massage room. Dr. Hether briefly stopped the massage to speak to his son. The door was partially open, but Chase Hether could not see inside the massage room. After speaking to his son, Dr. Hether closed the door and walked back to the massage table, where he again placed his hand in C.B.'s vaginal area and slid his fingers back and forth. Dr. Hether then shoved his hand further down C.B.'s panties and repeatedly thumped C.B.'s vaginal area. While Dr. Hether was thumping her vaginal area with one hand, he grabbed C.B.'s ankle with the other hand, while using the full pressure of his body weight on her body. Dr. Hether resumed making the grunting sounds and continued to make the sounds for a while. C.B. had approximately 27 massages at Dr. Hether's offices from the time she began treatment in April 2003 until June 11, 2003. The massage therapists who gave her those massages did not touch C.B.'s pubic area or touch the areas around C.B. breasts. After the massage, C.B. got dressed and went into another room to receive a chiropractic adjustment from Dr. Hether. Dr. Hether gave the chiropractic adjustment without any further inappropriate touching. After he concluded the chiropractic treatment, he asked C.B. personal questions about her living arrangements and occupation. C.B. went into the reception area of the office to leave the building. She saw Chase Hether and another man in the reception area. C.B. did not tell either man what had happened nor did she tell them that she would not be back to Dr. Hether's office for treatment. While Dr. Hether was touching C.B. inappropriately, she did not cry out, tell him to stop, or attempt to leave. When Chase Hether came to the door of the massage room, C.B. did not tell him what Dr. Hether was doing. C.B. did not try to stop the massage, leave Dr. Hether's offices, or tell others at Dr. Hether's office about the inappropriate touching because she was afraid of Dr. Hether and did not know what else Dr. Hether might do to her. She felt like she was a "visitor in her own body" and had no control over what was being done to her. She did not report the incident to the police department because she felt that the police were ineffective. C.B. did not go back to Dr. Hether's offices for treatment after the incident on June 11, 2003. She sought treatment from another chiropractic physician, Dr. Kimberly Watson, whom C.B. saw on June 23, 2003. C.B. told Dr. Watson what had happened to her at Dr. Hether's office. Dr. Watson advised C.B. that she could file a complaint with the Department of Health. C.B. did send a complaint to the Department of Health in June 2003, but she sent it to the wrong address. She got the correct address from Dr. Watson and filed a complaint with the Department of Health in September 2003. A year passed, and she contacted the Department of Health, wanting to know the status of her complaint. C.B. was told to file another complaint, which she did. Dr. Hether's wife, Kathe Hether, testified that she was at Dr. Hether's office the day of the incident and that as C.B. was leaving the office she spoke to C.B. for several minutes concerning her publishing business and that C.B. told her that she was going to another chiropractor that was nearer to her home. Mrs. Hether's testimony is not credible. Her husband of 36 years did not advise her until two months before the final hearing, that an administrative complaint had been filed against him. It is inconceivable that two and one-half years after their conversation, Ms. Hether vividly remembers talking to C.B. when there had been no reason to remember the conversation. Additionally, Ms. Hether's explanation for C.B.'s failure to return to Dr. Hether for treatment because C.B. wanted to go to a chiropractor closer to her home is also not credible. C.B. chose to seek treatment from Dr. Watson, whose office was about the same distance from C.B.'s home as Dr. Hether's office. C.B. also told Dr. Watson about the incident with Dr. Hether, explaining the reason that she discontinued treatment with Dr. Hether. C.B. has not brought a civil action against Dr. Hether for the incident on June 11, 2003. She filed the complaint with the Department so that Dr. Hether would not touch other patients inappropriately.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that James Hether, D.C., violated Subsection 460.413(1)(ff), Florida Statutes, by violating Subsection 456.072(1)(u) and Section 460.412, Florida Statutes; issuing a reprimand; imposing a $2,500 administrative fine; requiring a psychological evaluation by the professional resource network; and placing him on probation for two years, the terms of which would include a practice restriction prohibiting him from treating female patients without another certified health care professional in the room. DONE AND ENTERED this 28th day of July, 2006, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL 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 July, 2006.
The Issue Whether Rule 64B2-17.0025(4), Florida Administrative Code, constitutes an invalid exercise of delegated legislative authority.
Findings Of Fact Based on the oral and documentary evidence adduced at the final hearing and the entire record in this proceeding, the following findings of fact are made: The Board is the state agency responsible for the licensure and regulation of chiropractic medicine in the State of Florida. Section 456.013 and Chapter 460. Petitioner, John W. Sullivan, is a licensed Florida chiropractic physician subject to regulation by the Board. Petitioner, the Florida Chiropractic Physicians' Association, Inc., is a Florida corporation organized as a trade association to represent the interests of the Florida-licensed chiropractic physicians who compose a large portion of its membership. Dr. Sullivan is the president of the Florida Chiropractic Physicians' Association. The Board does not contest the standing of either Petitioner to initiate this proceeding. Petitioners have challenged Rule 64B2-17.0025(4) as an invalid exercise of delegated legislative authority. The challenged rule provides: 64B2-17.0025. Standard of Practice for Phlebotomy, Physiotherapy, and the Administration of Items for Which a Prescription is not Required; Prohibition of Prescribing or Administering Legend Drugs. Any chiropractic physician who in his practice uses physiotherapy, phlebotomizes, or administers items for which a prescription is not required must have acquired the competence to perform said service, procedure, or treatment through appropriate education and/or training. Any chiropractic physician who provides any treatment or service for which he or she has not been specifically educated or trained shall be deemed to be performing professional responsibilities which the licensee knows or has reason to know he or she is not competent to perform, and shall be subject to discipline pursuant to Section 460.413(1)(t), Florida Statutes. For the purpose of Chapter 460.403(8)(c),[1] Florida Statutes, "items for which a prescription is not required" include "proprietary drugs" such as patent or over-the-counter drugs in their unbroken, original package and which is not misbranded under the provisions of Chapter 499.001- 499.081, Florida Statutes. For the purpose of Chapter 460.403(8)(c), Florida Statutes, and this rule "administration" is defined as the administration of one dose of any proprietary drug, and the recommendation and direction of dosage levels for the patient's needs. Administration shall not include dispensing of repackaged proprietary drugs. All chiropractic physicians are explicitly prohibited by Chapter 460.403, Florida Statutes, from prescribing or administering to any person any legend drug. A legend drug is defined as a drug required by federal or state law to be dispensed only by prescription. For the purpose of this rule, any form of injectable substance is beyond the scope of practice for chiropractors. Notwithstanding the prohibition against prescribing and administering legend drugs under Section 460.403 or 499.0122, Florida Statutes, chiropractic physicians may order, store, and administer, for emergency purposes only at the chiropractic physician's office or place of business, prescription medical oxygen and may also order, store, and administer the following topical anesthetics in aerosol form: Any solution consisting of 25 percent ethyl chloride and 75 percent dichlorodifluoromethane. Any solution consisting of 15 percent dichlorodifluoromethane and 85 percent trichloromonofluoromethane. However, this rule does not authorize a chiropractic physician to prescribe medical oxygen as defined in chapter 499. Specific Authority 460.405 FS. Law Implemented 460.403(8)(c), (f), 460.413(1)(t), FS. History--New 10-17-90, Formerly 21D-17.0025, 61F2-17.0025, 59N-17.0025, Amended 2-16-98. (Emphasis added) Section 460.405 cited as the specific authority for the challenged rules, provides: The Board of Chiropractic Medicine has authority to adopt rules pursuant to ss. 120.536(1) and 120.54 to implement the provisions of this chapter conferring duties upon it. Section 460.403(9), paragraphs (c) and (f) of which are cited as a law implemented by the challenged rule, provides: 1. Chiropractic physicians may adjust, manipulate, or treat the human body by manual, mechanical, electrical, or natural methods; by the use of physical means or physiotherapy, including light, heat, water, or exercise; by the use of acupuncture; or by the administration of foods, food concentrates, food extracts, and items for which a prescription is not required and may apply first aid and hygiene, but chiropractic physicians are expressly prohibited from prescribing or administering to any person any legend drug except as authorized under subparagraph 2., from performing any surgery except as stated herein, or from practicing obstetrics. Notwithstanding the prohibition against prescribing and administering legend drugs under subparagraph 1., or s. 499.0122, pursuant to board rule chiropractic physicians may order, store, and administer, for emergency purposes only at the chiropractic physician's office or place of business, prescription medical oxygen and may also order, store, and administer the following topical anesthetics in aerosol form: Any solution consisting of 25 percent ethylchloride and 75 percent dichlorodifluoromethane. Any solution consisting of 15 percent dichlorodifluoromethane and 85 percent trichloromonofluoromethane. However, this paragraph does not authorize a chiropractic physician to prescribe medical oxygen as defined in chapter 499. * * * (f) Any chiropractic physician who has complied with the provisions of this chapter is authorized to analyze and diagnose abnormal bodily functions and to adjust the physical representative of the primary cause of disease as is herein defined and provided. As an incident to the care of the sick, chiropractic physicians may advise and instruct patients in all matters pertaining to hygiene and sanitary measures as taught and approved by recognized chiropractic schools and colleges. A chiropractic physician may not use acupuncture until certified by the board. Certification shall be granted to chiropractic physicians who have satisfactorily completed the required coursework in acupuncture and after successful passage of an appropriate examination as administered by the department. The required coursework shall have been provided by a college or university which is recognized by an accrediting agency approved by the United States Department of Education.[2] (Emphasis added) Section 460.413(1)(t), cited as a law implemented by the challenged rule, provides: The following acts constitute grounds for denial of a license or disciplinary action, as specified in s. 456.072(2): * * * (t) Practicing or offering to practice beyond the scope permitted by law or accepting and performing professional responsibilities which the licensee knows or has reason to know that she or he is not competent to perform. At issue in this case is whether the relevant Florida Statutes authorize chiropractic physicians to administer foods, food supplements and nutrients to patients by way of injection. If the statutes do authorize chiropractic physicians to administer these substances via injection, then the express prohibition on the administration of "any form of injectable substance" by chiropractic physicians contained in Rule 64B2-17.0025(4) is without legislative authorization. In 1923, the Florida Legislature established the "Florida State Board of Chiropractic Examiners" to oversee the licensing and discipline of chiropractic physicians. The scope of chiropractic practice was set forth as follows, in relevant part: Any Chiropractor who has complied with the provisions of this Act may adjust by hand the articulations of the spinal column, but shall not prescribe or administer to any person any medicine now or hereafter included in materia medica. . . . Chapter 9330, Section 12, Laws of Florida (1923). (Emphasis added) Section 12 of Chapter 9330, Laws of Florida, was amended in 1941 to provide, in relevant part: B. Any chiropractor who has complied with the provisions of this Act may: * * * (2) Chiropractors may adjust, manipulate or treat the human body by manual, mechanical, electrical or natural methods, or by the use of physical means, Physiotherapy (including light, heat, water or exercise) or by the use of foods and food concentrates, food extracts, and may apply first aid and hygiene, but chiropractors are expressly prohibited from prescribing or administering to any person any medicine or drug included in Materia Medica. . . . Chapter 20871, Section 1, Laws of Florida (1941). (Emphasis added) In 1957, the Florida Legislature amended the statute, then numbered Section 460.11, Florida Statutes, to provide, in relevant part: Any chiropractic physician who has complied with the provisions of this chapter may: * * * Chiropractic physicians may adjust, manipulate, or treat the human body by manual, mechanical, electrical or natural methods, or by the use of physical means, physiotherapy (including light, heat, water or exercise) or by the oral administration of foods and food concentrates, food extracts, and may apply first aid and hygiene, but chiropractic physicians are expressly prohibited from prescribing or administering to any person any medicine or drug. . . . Chapter 57-215, Section 3, Laws of Florida. (Emphasis added). Aside from being renumbered Section 460.03 by Chapter 79-211, Section 1, Laws of Florida, the relevant language of the statute remained essentially unchanged between 1957 and 1986. Chapter 86-285, Section 2, amended Section 460.03(3), to provide: Chiropractic physicians may adjust, manipulate, or treat the human body by manual, mechanical, electrical, or natural methods or by the use of physical means or physiotherapy, including light, heat, water, or exercise, or by the use of acupuncture, or by the administration of foods, food concentrates, food extracts, and proprietary drugs, and may apply first aid and hygiene, but chiropractic physicians are expressly prohibited from prescribing or administering to any person any legend drug. . . . (Emphasis added) The underscored language indicates two significant changes made by the Legislature in 1986. First, the term "oral administration" was changed simply to "administration," and "proprietary drugs" were added to the list of items that chiropractic physicians were allowed to administer. Second, the items that chiropractic physicians were prohibited from prescribing or administering was changed from "any medicine or drug" to "any legend drug." Chapter 86-285, Section 1, Laws of Florida, also added the following language to Section 460.403(3)(f), Florida Statutes (currently Section 460.403(9)(f)): Any chiropractic physician licensed after October 1, 1986, may not phlebotomize or use physiotherapy or acupuncture or administer proprietary drugs until certified by the board to use any of such procedures. Certification shall be granted to chiropractic physicians licensed after October 1, 1986, who have satisfactorily completed the required coursework in the procedure or procedures for which certification is sought, and after successful passage of an appropriate examination as administered by the department. The required coursework shall have been provided by a college or university which is recognized by an accrediting agency approved by the United States Department of Education. Chiropractic physicians licensed after October 1, 1986, seeking certification in one or more of the procedures for which certification is required may elect to take the certification examination at the time of taking the initial licensing examination or at any subsequent examination. Nothing herein shall be construed to require chiropractic physicians who have met all requirements for licensure prior to the effective date of this act to become certified to phlebotomize or use physiotherapy. Dr. Ronald J. Hoffman testified that he was a member of the Board in 1986 and was directed by the Board's chairman to create the syllabus for the certification course in proprietary drugs required by the 1986 amendment to the statute, quoted above. In conjunction with the National College of Chiropractic, Dr. Hoffman designed a 72-hour certification course, including three to four hours of instruction relating to injectable nutrients. In Chapter 97-247, Section 1, Laws of Florida, the term "proprietary drugs" was deleted from the list of items that chiropractic physicians may administer. In its place was inserted the term "items for which a prescription is not required," which is the current language of Section 460.403(9)(c), set forth in Finding of Fact 5, supra. Chapter 97-247 also deleted the requirement that a chiropractic physician obtain certification to administer proprietary drugs. Petitioners' challenge focuses on the language in Rule 64B2-17.0025(4) stating that "any form of injectable substance is beyond the scope of practice for chiropractors." Petitioners contend that the statutory language permitting chiropractic physicians to "administer" foods, food concentrates, and food extracts (generally, vitamins and nutrients) by its terms allows chiropractic physicians to inject those substances into their patients. Petitioners admit that between 1955 and 1986, the statute limited their practice to the "oral administration" of the listed substances. However, Petitioners also argue that the Legislature's changing the term "oral administration" to "administration" in 1986, evinced a clear intent to allow chiropractic physicians to administer foods, food concentrates, and food extracts in any manner, including by injection. In his testimony, Dr. John Sullivan went even further, arguing that the term "administer" can only mean "administer by injection." His contention on this point was echoed by Petitioners' witness Dr. Roderic Lacy. Another witness for Petitioners, Dr. Paul Yocom, D.C., testified that "administration" at least implies some action by the physician and that a physician does not typically place a pill in the patient's mouth. Dr. Lacy testified that when the Legislature removed the word "oral" from the statute in 1986, "everybody was under the impression they were going to be able to do injectable nutrition" because the certification course in proprietary drugs included a section on injectable nutrients. Dr. Lacy stated that this impression changed when "practically nobody passed" the certification examination and the issue of injecting vitamins and nutrients "kind of faded away." Petitioners contend that it is nonsensical that the law would permit them to prescribe and administer foods, food concentrates, and food extracts in an oral form, but not to administer the same substances via subcutaneous injection. Dr. Sullivan testified that vitamins are food, whether taken orally or by injection. The body uses the vitamins in the same way regardless of the method by which the vitamins enter the body. The same vitamin does not become a "drug" simply because the means of administering it changes. Dr. Sullivan pointed out that some people cannot metabolize certain vitamins orally and must take them by injection. Dr. Lacy testified that an inability to administer vitamins and nutrients by injection restricts a chiropractic physician's ability to treat patients. He noted that the absorption rate when vitamins are taken orally is 10 to 20 percent, whereas the absorption rate for injections is 100 percent. If a patient is deficient in a certain vitamin or nutrient, the number of oral doses the patient would need to address the deficiency could make the patient sick. Dr. Lacy testified that he was unaware of any instance of a serious adverse reaction related to the injection of a vitamin or nutrient. Dr. Lacy noted that "injectable" simply means that the vitamin is in a sterile, water soluble solution, and that the character of the vitamin itself is unchanged. Both Dr. Sullivan and Dr. Lacy testified that because injectable vitamins are water soluble, any excess amounts are eliminated from the body via urination. Petitioners attacked the term "legend drug" as a vague and overbroad term in the Rule. Dr. Lacy testified that "legend" simply means "label," and, therefore, that any drug with a label on it could be termed a "legend drug." Given the broad meaning of "legend," Dr. Lacy argued that there could be "legend drugs," "legend vitamins," and even "legend foods," though no one questions the right of a chiropractic physician to prescribe foods and vitamins. Dr. Lacy testified that he contacted the Food and Drug Administration to find out its definition of the term "legend drug." He stated that FDA informed him that it was a "slang term" used interchangeably with the term "prescription drug" and without a written definition. Dr. Yocom testified that he spent "many hours" on the internet in search of a definition of the term "legend drug." He could not find that the term "existed per se." He found references to the term "legend drug," but always without definition. Dr. Yocom testified that in his mind, "legend" simply means "a description, a label." Dr. Sullivan testified that "legend" does not mean "prescription only." A "legend" on a label simply tells the user what is in the product and how to use it. Dr. Sullivan testified that such products as aspirin, Tylenol, Benadryl, Excedrin P.M., and even oral vitamins are "legend" products because their labels contain instructions for their use. In addition to their dispute with the Board's use of the terms "administration" and "legend drug," Petitioners, by their testimony, indicate that they have a different understanding of the term "prescription" than that employed by the Board. Dr. Yocom testified that he "prescribes" hot packs, cold packs, and exercise to his patients. Dr. Sullivan "prescribes" certain diets to his weight loss patients. This testimony disregards the common understanding of the term "prescription," i.e., an order for medication, therapy, or a therapeutic device given by a properly authorized person to a person properly authorized to dispense or perform the order. In the context of drugs, "prescription" carries a connotation that the patient will receive a medication that the patient could not lawfully procure without a physician's order.3 While it is literally true that a physician may "prescribe" such things as cold packs, exercise, and diets, the patient does not require a physician's prescription to obtain them. Petitioners' testimony on this point cannot be credited. The Board's position is that Rule 64B2-17.0025 was adopted in 1990 precisely because many chiropractors were confused about the effect of the 1986 legislation. Paul Lambert, the general counsel for the Florida Chiropractic Association, testified that, at the time the legislation passed, he believed that chiropractic physicians were authorized to administer injectable vitamins and that he drafted a legal opinion in support of that position in 1989. Testimony at the hearing established that many chiropractors, including some members of the Board, shared Mr. Lambert's opinion. The Board's position is that the Rule, defining the terms "administration" and "legend drug," was necessary to dispel this misconception. Dr. Hoffman testified that, after he prepared the certification course, he researched the question of whether Vitamin B-12, the most commonly used injectable vitamin, was a legend drug. He concluded that it was. Dr. Hoffman testified that this fact appeared to be common knowledge among pharmacists but that chiropractors seemed unaware of it. He stated that he likely would not have included instruction on injectable vitamins in the certification course had he known injectable vitamins were considered legend drugs. As a result of his research, Dr. Hoffman became a firm proponent of a rule to disallow the use of injectable vitamins by chiropractic physicians. Dr. Hoffman testified that he helped draft the language of the Rule and helped to promulgate it as a member of the Board in 1990. The Rule defines "legend drug" as "a drug required by federal or state law to be dispensed only by prescription." As noted above, Petitioners challenged this definitional conflation of the terms "legend drug" and "prescription drug." The Department responded that every "federal or state law" relevant to the medical professions and to the profession of pharmacy treats the terms as equivalent and that the Rule simply clarified that the 1986 legislation intended "legend drug" to carry this common meaning. This issue is significant, if not dispositive, of this case, because the Board introduced persuasive evidence that the FDA considers all injectable drugs, including injectable vitamins and nutrients, to be "legend" or "prescription" drugs. William Nychis, acting director of the FDA's Division of New Drugs and Labeling Compliance, testified that insulin is the only item intended for parenteral administration that the FDA does not classify as a drug. Mr. Nychis began his analysis by referencing the definition of "drug" found in Section 201(g) of the Federal Food, Drug, and Cosmetic Act, codified at 21 U.S.C. Section 321(g)(1): The term "drug" means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and articles (other than food) intended to affect the structure or any function of the body of man or other animals; and articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance with the requirements of section 343(r) of this title is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 343(r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement. Mr. Nychis testified that "legend drug" and "prescription drug" are considered synonymous terms by the FDA. He stated that a legend drug is one for which adequate directions for use by the lay person cannot be written, and which therefore must carry the "Rx" or “prescription only” legend. In contrast, a "proprietary" or over-the-counter drug is one that can bear adequate directions for use by the lay person. The classification of drugs is performed on a case-by- case basis. Prescription drugs are articles that because of their toxicity or other potential for adverse effect, or because of their method of use, or because of the collateral measures necessary for their use, are not safe for use except under the supervision of a practitioner authorized by state law to administer such a drug. Prescription drugs are not available to the consumer except through an authorized practitioner. Mr. Nychis testified that any item, except insulin, administered by injection is classified by the FDA as a prescription drug. Products that are intended to be injected, because of the collateral measure necessary for their use, are not considered safe except under the supervision of a practitioner authorized by law to administer and prescribe such drugs. Mr. Nychis emphasized that it is up to the states to determine who is a practitioner authorized by law to prescribe and administer prescription drugs and that the FDA takes no position as to the propriety of allowing chiropractic physicians to prescribe or administer injectable vitamins. Mr. Nychis testified that as early as 1945, the FDA, in what is called trade correspondence, first began to classify injectable vitamins and nutrients as prescription drugs. In 1951, the definition was clearly set forth in Section 503(b)(1) of the Food, Drug and Cosmetic Act, codified at 21 U.S.C. Section 353(b)(1) and set out in full in the Conclusions of Law below. For at least 50 years, the FDA has not classified an injectable vitamin or nutrient as anything other than a prescription or legend drug. Mr. Nychis testified that even injectable water is classified as a drug. Legend drugs or prescription drugs are identified as "Rx" in the FDA publication, "Approved Drug Products with Therapeutic Equivalence Evaluations," also known as "The Orange Book." Large numbers of injectable vitamins and nutrients are listed as "Rx" in the Orange Book. Some fat-soluble vitamin tablets and injections are also listed as "Rx" or prescription. Even "soy bean oil" (vitamin E) can be found listed in the Orange Book as a prescription drug in its injectable form. Appendix C to the Orange Book lists 43 "routes of administration" for drug products, demonstrating that "injection" is not necessarily an equivalent term to "administration," as contended by Dr. Sullivan. In any event, the use of the term "administration" of food products in Section 460.403(9)(c) must be read in conjunction with the statute's prohibition on "administering" legend drugs. Once it is established that injectable vitamins are legend drugs, then it follows that "administration" of food products, whatever it might include, cannot include the method of injection. Jerry Hill has been a pharmacist for more than 30 years and is the bureau chief of statewide pharmaceutical services for the Florida Department of Health, responsible for the licensure of drug wholesale facilities and manufacturing facilities. Mr. Hill testified that the term "legend drug" has been in use for at least as long as he has been a pharmacist. The "legend" on these products is the notice that federal or state law prohibits dispensing them without a prescription or the "Rx only" notice. Mr. Hill testified that the statutes enforced by his agency treat "legend drug," "prescription drug," and "medicinal drug" as interchangeable terms. He cited, as an example Section 499.003(25), which provides: "Legend drug," "prescription drug," or "medicinal drug" means any drug, including, but not limited to, finished dosage forms, or active ingredients subject to, defined by, or described by s. 503(b) of the Federal Food, Drug, and Cosmetic Act or s. 465.003(8), s. 499.007(12), or s. 499.0122 (1)(b) or (c). As did Mr. Nychis, Mr. Hill testified that drugs are classified not merely by their substance, but by their intended use and method of administration as well. Thus, he contradicted the Petitioners' testimony that a vitamin is considered "food" regardless of its method of administration. Mr. Hill noted that in its oral dosage form, Vitamin B-12 may be classified as a dietary supplement. If the label indicates some use to treat a medical condition, Vitamin B-12 may be classified as an over- the-counter medication. In its injectable form, Vitamin B-12 is a legend drug, available only by prescription. Mr. Hill also agreed with Mr. Nychis that, except for insulin, all dosage forms in which the route of administration is injectable are classified as prescription drugs. Mr. Hill stated that no injectable products may be purchased from a Florida pharmacy without a prescription. He testified that it would be his duty to seize any injectable Vitamin B-12 that he found in the possession of a chiropractic physician and to prosecute the chiropractic physician for unlawful possession of a prescription drug. Everett A. Kelly has been a licensed pharmacist in Florida since 1961 and served in the Florida House of Representatives for 22 years. Mr. Kelly confirmed Mr. Hill's testimony that the term "legend drug" is synonymous with the term "prescription drug." The referenced "legend" is the identification that the item is "Rx only" or may be dispensed only by prescription. Mr. Kelly testified that Florida defers to the FDA's classifications of substances as "drugs." On this point, both Mr. Hill and Mr. Kelly noted that federal law allows the states to make their drug laws more restrictive than the federal laws, but does not allow the states to enact less restrictive laws. Mr. Hill cited the example of ephedrine hydrochloride, which the FDA classifies as an over-the-counter drug, but for which Florida requires a prescription. Mr. Kelly also confirmed the testimony of Mr. Nychis and Mr. Hill that all injectable items, except insulin, are legend drugs. Mr. Kelly explained that insulin is excepted because diabetics must use it daily for their entire lives, and that the diagnosing physician's initial prescription is considered sufficient for the patient to receive insulin in perpetuity. Mr. Kelly stated that, aside from insulin, every other injectable product, including water for injection, is a legend drug. The testimony of Mr. Hill, Mr. Nychis, and Mr. Kelly as to the meaning of the term "legend drug" is credited insofar as it represents their understanding of the common usage in their respective professions, based upon federal and state statutory definitions. The contrary testimony of Petitioners' witnesses as to the meaning of "legend drug" cannot be credited. These chiropractic physicians were essentially offering a layman's view of the term derived from internet searches, phone calls to unidentified FDA employees, and a self-serving disregard of the fact that "legend drug" is defined in state and federal statutes. In summary, the testimony established that when the 1986 legislation became law, many chiropractors focused on the change of "oral administration" to "administration" and concluded that they were now free to administer injectable vitamins and nutrients to their patients. Even some members of the Board shared this belief, as evidenced by the inclusion of instruction regarding injectable nutrients in the certification course for proprietary drugs. However, closer examination of the issue and consultation with professionals in other health fields led the Board to an understanding that the term "legend drug" includes any injectable substance, even vitamins and nutrients that may be considered foods or over-the-counter drugs in their oral form. This understanding, and the need to make all chiropractic physicians aware of the true state of the law, led the Board to adopt Rule 64B2-17.0025 in 1990. Petitioners raised several other issues that merit brief discussion. Petitioners attempted to offer evidence of legislative intent regarding the 1986 legislation by way of statements by Dennis Jones, the state representative who sponsored the relevant amendments. The Board attempted to counter this evidence with testimony by Mr. Kelly, who was also in the state House of Representatives in 1986. The undersigned declined to accept any of this testimony, finding that an individual legislator's statements cannot form the basis for a finding of legislative intent. See State v. Patterson, 694 So. 2d 55, 58 n.3 (Fla. 5th DCA 1997), and cases cited therein (testimony of individual legislators as to what they intended to accomplish is of doubtful worth in determining legislative intent and may not even be admissible). Petitioners argued that certain members of the Florida Chiropractic Physicians' Association, having completed the certification course and passed the examination in the late 1980's, continue to hold certification in the administration of proprietary drugs, including injectable vitamins. As noted above, the Legislature in 1997 removed the statutory authority for the Board to grant certification to chiropractic physicians in proprietary drugs. In fact, the current statutory scheme permits any chiropractic physician to administer "items for which a prescription is not required," rendering the old certification program meaningless. Further, the evidence at the hearing established that the certifications in proprietary drugs could not have certified their holders to administer injectable vitamins, which are legend drugs that no chiropractic physician can be authorized to administer under the relevant statutes. Petitioners offered the 1987, 1989, and 1990 editions of the "Florida Health Care Atlas" as evidence that the 1986 legislation authorized chiropractic physicians to administer injectable vitamins. Each of the cited editions of the Atlas does, in fact, state that "chiropractors may now . . . administer proprietary drugs and injectable vitamins upon certification . . . ." However, the Board pointed out that the Atlas was a publication of the Department of Health and Rehabilitative Services, not the Board of Chiropractic Medicine or its parent agency at the time, the Department of Professional Regulation. The Board disavowed the inaccurate information in the Atlas, which was in any event a reference guide lacking the legal effect of a statute or rule. Finally, Petitioners offered documentation that the Board in 2000 approved a 50-hour continuing education course that included a three hour section on "injectable nutrients." However, the notice of Board approval included an italicized notice that the three-hour section on injectable nutrients would not be accepted. Subsequently, in January 2001, the Board approved a three-hour course in injectable nutrients for continuing education credit but required the presentation to include a disclaimer that all or portions of the material presented constituted practice outside the scope of the profession.
Findings Of Fact The parties have stipulated to the facts in this case as follows: The Respondent, Clifford Fruithandler, D.C. is and has been at all times material hereto [sic] the Administrative Complaint filed in DOAH Case No. 89-7036, (DPR Case Number 0094598) a chiropractor licensed in the State of Florida having been issued license number CH 0004149. The Respondent's address is 5417 West Atlantic Boulevard, Margate, Florida 33063. The Respondent, in his capacity as a licensed chiropractor caused to be published an advertisement in the North West Medical Guide in Broward County. The advertisement was published on September 16, 1987. The advertisement identified the Respondent's chiropractic practice as "Advanced Chiropractic and Pain Control Center". The Respondent has been subject to discipline by the Board of Chiropractic in DPR Case Number 44292, 40777, and 28914. On or about March, 4, 1988, the Department of Professional Regulation wrote a letter to Respondent which stated "Please be advised that the Department has received a complaint based on the enclosed advertisement. The allegations are: (1) Advance Chiropractic implies that you possess skills and or other attributes which are superior to other chiropractors..." Within one week following the receipt of such letter by Respondent, the Respondent changed the name of the clinic and stopped using the name "Advanced Chiropractic and Pain Control". Prior to the receipt of DPR's letter of March 4, 1988, Respondent had received no complaints from DPR, the Board of Chiropractic, or from any patient regarding the use of such name.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Chiropractic Examiners enter a Final Order finding Respondent guilty of the allegations set forth in the Administrative Complaint, issuing a reprimand to the Respondent and assessing a fine against Respondent in the amount $750.00. DONE AND ORDERED in Tallahassee, Leon County, Florida, this 29th day of April, 1991. J. STEPHEN MENTON Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 29th day of April, 1991. COPIES FURNISHED: Michael A. Mone, Esquire Senior Attorney Department of Professional Regulation 1940 North Monroe Street Suite 60 Tallahassee, Florida 32399-0792 Roger W. Calton, Esquire Qualified Legal Representative 30131 Town Center Drive Suite 177 Laguna Niguel, CA. 92677-2040 Patricia Guilford Executive Director Department of Professional Regulation 1940 North Monroe Street Suite 60 Tallahassee, Florida 32399-0792 Jack McRay General Counsel Department of Professional Regulation 1940 North Monroe Street Suite 60 Tallahassee, Florida 32399-0792
The Issue The issues in this case are whether Respondent engaged in sexual misconduct in the practice of chiropractic medicine, in violation of section 460.412, Florida Statutes; and, if so, what is the appropriate sanction.
Findings Of Fact The Board is the state agency charged with regulating the practice of chiropractic medicine in the State of Florida, pursuant to section 20.43 and chapters 456 and 460, Florida Statutes. At all times material to this proceeding, Dr. Rodriguez was a licensed chiropractor in the State of Florida, having been issued license number CH 9812 on September 17, 2009. Dr. Rodriguez's address of record with the Department is 1840 Northwest 122nd Terrace, Pembroke Pines, Florida 33026. Patient D.H. was a 22-year-old patient of Dr. Rodriguez. She had been referred to Dr. Rodriguez by her mother, also a patient. Patient D.H. was the one who suggested initial treatment with Dr. Rodriguez. She had seen him about six times over a period of two months. On or about June 6, 2012, Patient D.H. presented to Dr. Rodriguez for chiropractic treatment. Dr. Rodriguez began treating Patient D.H. in one of the treatment rooms in his practice. As she was turning over on the examination table, Patient D.H.'s left breast was exposed. Dr. Rodriguez commented on her breast being exposed. Patient D.H. replaced her breast under her tank top. As Dr. Rodriguez continued with his treatment, her breast was again exposed, prompting Dr. Rodriguez to say that Patient D.H. was getting him excited, or words to that effect. Dr. Rodriguez touched both of her breasts with his hands. He then kissed her breasts. Patient D.H. testified that she was in shock because his actions were sudden and caught her off guard. Dr. Rodriguez left the room. Dr. Rodriguez's staff placed Patient D.H. in a massage chair in a common area of the office. After Patient D.H. stated that she still had pain, she was taken into another room for an additional treatment on her shoulder. In the new room, Patient D.H. lay down on the treatment table. After placing some patches on her shoulder, Dr. Rodriguez again touched her breasts. He placed his hand inside her pants and inserted two fingers into her vagina. She testified that she told him to stop. Dr. Rodriguez again told her how she excited him. Patient D.H. later testified that she was in shock and unable to react. Dr. Rodriguez and Patient D.H. made a "pinky promise" not to say anything, and then Dr. Rodriguez washed and dried his hands. He placed a Chinese herbal remedy above her left breast, told her to sleep, and left the room. When he returned, Patient D.H. began crying. Dr. Rodriguez gave her a hug and kissed her on the cheek. While Patient D.H. was in a treatment room with Dr. Rodriguez, he engaged in sexual contact with her which was outside the scope of her medical treatment. Other than as described, Patient D.H. made no complaint to Dr. Rodriguez, nor did she complain to an office staff member. Patient D.H. left Dr. Rodriguez's office and started driving to her cousin's house. She then pulled over and called the police and her mother to tell what had happened. Patient D.H.'s mother testified that she received a phone call from her daughter about 5:00 p.m., saying that Dr. Rodriguez had molested her, and immediately went to meet her. Patient D.H.'s parents took her to the Cooper City district office of the BCSO to report the crime. On June 11, 2012, in conjunction with a criminal investigation by the BCSO, Patient D.H. made a controlled telephone call to Dr. Rodriguez while in the presence of a detective. During the conversation, Dr. Rodriguez said that he did not want to discuss things on the telephone because he could not be sure he was not being recorded, and asked Patient D.H. to come see him at the office. Patient D.H. said she would be uncomfortable seeing him and that is why she had called on the telephone. Their conversation included words to the following effect: Patient D.H.: Do you . . . do you really do this to your other patients? Dr. R.: I don't. That's why I'm . . . I couldn't sleep this weekend. I . . . I . . . I'm exhausted. I'm physically and mentally exhausted. Patient D.H.: But why me? Dr. R.: I don't know. It just happened, hon. That's what I'm telling you, it just, it just happened. Patient D.H.: I just want to know why me? Dr. R.: I don't . . . I don't know . . . I, I just don't know. Um . . . you know, and I wasn't sure because you know, um . . . you know you, you um, when you came about, you showed me your breasts, um . . . . Patient D.H.: It wasn't . . . you know, it was an accident, I wasn't trying to personally . . . . Dr. R.: No, but you know, but when you did the other part, you know, then I thought that that was um. Patient D.H.: What other part are you talking about? Dr. R.: No dear, no, your breasts, and that was an invitation . . . or an open, you know, "here" and for some reason we were talking about stuff, it's a blank to me. I do not remember . . . if you asked me . . . it was just, I do not remember, um, how exactly everything happened, but it just happened. Patient D.H.: Don't you remember . . . don't you remember putting your hand on my breasts and putting your two fingers in my vagina? Do you remember that? Dr. R.: Yes. Patient D.H.: Yes, you do remember that, right? Dr. R.: Hon, I don't even want to, I don't even want to go there. I don't even want to be going there, because I didn't feel comfortable with that at all. Patient D.H.: How, how do you think I feel? I'm not comfortable at all myself. Dr. Rodriguez later engaged the services of a forensic audio engineer who generated an enhanced audio version of the above-described controlled telephone call. During this call, Detective Wernath's voice can be heard in the background, coaching Patient D.H. through portions of the conversation. The criminal investigation also found that a DNA sample from a buccal swab taken from Dr. Rodriguez matched DNA collected from Patient D.H.'s breast. As Mr. Rhodes testified, the chance of a false positive was less than one in 30 billion. Dr. Rodriguez has admitted the sexual activity, while maintaining that his conduct was invited by Patient D.H.'s actions. Specifically, Dr. Rodriguez testified that he believed that Patient D.H. intentionally made her breast "slip out" of her tank top several times, that it was not an accident. He testified that when he told her that he could see her exposed breast, she responded, "Oh, I don't mind." He testified that Patient D.H. was being flirtatious and, by her provocative actions, was encouraging his behavior. Dr. Rodriguez's testimony that he believed Patient D.H. encouraged his sexual misconduct is supported by his statements directly to Patient D.H. on the recorded call, when he thought no one else was listening, and is credible. But regardless of what Dr. Rodriguez may have perceived, or the degree, if any, to which Patient D.H. was complicit in Dr. Rodriguez's sexual misconduct, her involvement would not excuse his actions. A chiropractor is not free to engage in sexual activity with his patient even if the patient encourages or consents to it. There was scant evidence in the record to suggest that Dr. Rodriguez accepts or understands this professional responsibility. Patient D.H.'s testimony as to Dr. Rodriguez's actions was clear and convincing. Her testimony as to his actions is credited and is confirmed by his own statements in the controlled telephone call and at hearing. Respondent's touching of Patient D.H.'s breasts with his hand and mouth and insertion of his fingers into her vagina constituted engaging in sexual activity with a patient and was sexual misconduct in the practice of chiropractic medicine. Patient D.H. engaged in a civil lawsuit against Dr. Rodriguez. She has since executed a release in that case. Dr. Rodriguez has not previously been subject to disciplinary action by the Board. Dr. Rodriguez credibly testified that he has installed video cameras in the treatment rooms to ensure that there will be no further incidents. He noted that the purpose of these cameras was to protect him. Dr. Rodriguez demonstrated little or no remorse, the focus of his spirited testimony being directed towards the provocative conduct of Patient D.H., not his own inappropriate actions. Revocation or suspension of Dr. Rodriguez's professional license would have a great effect upon his livelihood.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Florida Department of Health, Board of Chiropractic Medicine, enter a final order finding Dr. Enrique Rodriguez in violation of section 460.412, Florida Statutes; revoking his license to practice chiropractic medicine; and imposing costs of investigation and prosecution. DONE AND ENTERED this 29th day of March, 2019, in Tallahassee, Leon County, Florida. S F. SCOTT BOYD 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 29th day of March, 2019.
Findings Of Fact Petitioner, Sherman College of Straight Chiropractic, is a chiropractic college located in Spartanburg, South Carolina. It is accredited by the Southern Association of Colleges and Schools (SACS), a regional accreditation agency that is recognized by the U.S. Department of Education (USDOE) and the Council on Postsecondary Accreditation (COPA). Sherman College is also accredited by the Southern Conference of Straight Chiropractic Associations (SCASA), a professional accreditation agency which formerly was recognized by USDOE, but has never been recognized by COPA. Sheryll Indiaan is a graduate of Sherman College who applied for examination and licensure as a chiropractic physician under rule 21D- 11.001(2)(c), F.A.C. On April 7, 1992 the Board of Chiropractic (Respondent, or Board) issued an order of intent to deny the application. After denying Dr. Indiaan's request for formal administrative hearing and conducting an informal hearing on December 10, 1992, the Board issued its final order of denial on March 3, 1993. That order is on appeal to the First District Court of Appeal. The basis for the Board's denial of Dr. Indiaan's application as stated in its final order is: ...as a matter of law, Sherman did not meet the requirements of section 460.406(1)(c), F.S., because it had only regional or institutional accreditation by USDOE and COPA and it did not have professional or specialized accreditation by an agency recognized by USDOE and COPA. (Final Order entered March 3, 1993) Section 460.406(1)(c), F.S. was amended in 1990, as follows: 460.406 Licensure by examination.-- (1) Any person desiring to be licensed as a chiropractic physician shall apply to the department to take the licensure examination. * * * The department shall examine each applicant who the board certifies has: * * * (c) Submitted proof satisfactory to the department that he is a graduate of a chiropractic college accredited by, or has status with an agency or its successor which is recognized and approved by, the U.S. Office of education or and the Council on Postsecondary Accreditation or by the department, provided that the department applies the same standards used by the U.S. Office of Education which are applicable to this state when approving an agency. In evaluating any application for approval as an accrediting agency, the department shall give full recognition to the different philosophies of chiropractic prevailing in the profession and shall not reject any application solely because the accrediting agency is an adherent of one such philosophy as distinguished from another. No application for a license to practice chiropractic shall be denied solely because the applicant is a graduate of a chiropractic college that subscribes to one philosophy of chiropractic as distinguished from another. Any application for approval filed by any accrediting agency shall be acted upon by the department within 180 days of the filing of the application. The policy of the Board, as reflected in the Indiaan denial order, was first formulated and applied in 1991, after the Board was informed of the amendment to section 460.406, F.S. Six Sherman College graduates were told, the day before the March examination, that they would not be permitted to sit for the examination. After a follow-up emergency meeting, the Board voted to allow the students to take the examination, but that licensure would be withheld pending verification of Sherman College's accreditation. Prior to this action, Sherman College's graduates had been allowed to take the examination. On August 8, 1991, the Board considered argument and testimony and voted to adopt its policy of requiring both regional and professional accreditation. That policy is the basis for the rule amendments which are the subject of this proceeding. Rule 21D-11.001(2), F.A.C. provides requirements for application for licensure examination. The amendment, published on August 21, 1992, provides: 21D-11.001 Application for Licensure Examination. No change. No change. No change. No change. Are graduates of a chiropractic college accredited by, or has (sic) status with an agency, or its successor, which is recognized and approved by the United States Department of Education, and the Council on Postsecondary Accreditation or by the Department of Professional Regulation, provided that the Department of Professional Regulation applies the same standards used by the United States Department of Education which are applicable to the State of Florida when approving an agency. For the purpose of determining whether a chiropractic college is recognized and approved by the United States Department of Education and Council on Postsecondary Accreditation, the Board will require the applicant to show not only regional accreditation but also professional accreditation of the chiropractic college from which the applicant graduated. When no hearing was requested, the rule became effective. Notice of amendment to rule 21D-17.0045(1), F.A.C. was published on February 17, 1993. That rule addresses requirements for an individual to enter a chiropractic physician training program. The proposed amendment provides as follows: 21D-17.0045 Chiropractic Physician Candidate Training Program. (1) For the purpose of this rule, a "chiropractic physician candidate" is defined as an individual who has received his/her degree in chiropractic from a chiropractic college accredited by, or has status with which an agency or its successor which is recognized and approved by the U.S. Office of Education and the Council on Postsecondary Accreditation or by the department, provided that the department applies the same standards used by the U.S. Office of Accreditation which are applicable to this state when approving an agency. To demonstrate recognition and approval by the U.S. Office of Education and the Council on Postsecondary accreditation, a candidate must show that the chiropractic college from which the candidate received his/her degree, maintained both regional and professional accreditation. Sherman College has regional, but not professional accreditation, recognized by both USDOE and COPA. USDOE and COPA each recognize regional and professional accrediting agencies. Accreditation, both regional and professional, is a quality assurance process for educational institutions. While the focus of regional versus professional accreditation might be different, for a single purpose institution such as a Bible college, business school or chiropractic school, the difference is negligible. This testimony by Ralph G. Miller, executive vice president of the Council on Chiropractic Education (CCE), Respondent's expert on accreditation, is revealing: Q [by Ms. Daire] Is there a difference between regional or institutional accreditation from specialized or programmatic specialized accreditation? A [by Dr. Miller] You know, let me state a paradox in accreditation. The paradox is they are the same, but they are different. Q Will you please explain? A The form is the same, the process, and this is foisted by agreement of the associations upon the organizations and also by societal need as well as in these cases, U.S. DE and COPA. The differences come in the substantive aspects of what is required of the professional or programmatic areas versus the institutional or the regional. The institutional and regional are almost synonymous. In fact, they are. In some cases you'll have single-purpose institutions, such as Bible colleges, theology schools, some business, the association of private schools, business schools. These are single-purpose institutions not recognized by the regionals so they sort of dangle out there, and COPA has recognized them as a special unit, but U.S. DE does it a little differently. Q Okay. I don't know if you have answered my question, but is regional accreditation different from that of professional accreditation not with regard to process and procedure but with regard to the substance? A Yes, substance. Q The substance is different? A The substance is different? Q How is it different? A I think there is a societal aspect when one must consider when we review professional accreditation and that is, assurance of quality in the professional areas. The professional associations usually speak to this in a variety of ways, some call them functions; other call them standards; other call it essentials. The regionals have broadly stated standards which look at the institution as a whole to ascertain quality of academic ability, to assure that the institutions are doing what they are saying but not with the specificity as the professional association may, and I'm not saying that they are any less effective. Q Is there a need for both types of accreditation? A Yes, there is. Q What is the need that is met by institutional or regional accreditation? A It's assurance of the quality of education of our young people that go through the various disciplinary programs of history and sociology and possibly -- I can't think some of the sciences, chemistry, these various disciplines that need, society needs insurance. We don't have a governmental agency, if you would, such as the Ministry of Education that reviews these. So this has been a voluntary and very effective part of the post secondary accreditation over 100 to 125 years. * * * Q Is there a difference in site team visits professional and institutional, or are they the same? A In form they are the same, but in substance they can be very similar. Q Tell me about how they are the same in form. A They are the same in terms of the process, the kinds of -- the team effort, possibly the composite review of the standards and the process they have in ascertaining whether or not the institution is doing what it says it's doing. But the focus with the professional organizations comes in the area of the clinical component or that component dealing with the specific professional, profession need ahead. (transcript, pp 220-223) Louis W. Bender was qualified as an expert in accreditation matters on behalf of Petitioner. He is an accreditation consultant who has served on regional accreditation review teams and on a review team for SCASA, a professional accreditation agency. In his experience, the regional and professional agencies alike determine whether the programs being taught are preparing students for employment in their field. This includes review of all aspects of the educational program, from the course work to the clinical. A regional review team for a single purpose institution such as Sherman College would include individuals with knowledge of the curriculum in the chiropractic and the general education area. Members on the team would include individuals in the field being reviewed, like chiropractors. The SACS accreditation team that evaluated Sherman College included chiropractors and academicians from chiropractic colleges with professional accreditation. They evaluated the clinical program and curriculum leading up to the clinical program and commented on it in their review. The debate over relative merits of professional versus regional accreditation is mirrored in the debate over "straight" versus "mixer" philosophy of chiropractic. Simply described, the straight chiropractic professional concentrates on remedying subluxations (misalignments) of the spine as a means to good health. The "mixer" professional is involved in a wider range of health care services. Sherman College is a "straight" chiropractic institution, as reflected in its name, but it still recognizes that state licensing requirements throughout the country mandate the teaching of courses beyond straight practice; the college offers those courses to enable its students to pass state examinations and comply with state laws. Section 460.406(1)(c), F.S. expressly forbids the denial of an application for licensure or examination based on the preference of one philosophy over another. Petitioners contend that the rule amendments at issue violate that prohibition. The Council on Chiropractic Education (CCE) is the only chiropractic professional accrediting agency that is recognized by both USDOE and COPA. Thus, CCE accreditation is required for compliance with the rule amendments. Sherman College is not accredited by CCE but has applied for that accreditation. CCE does accredit programs that ascribe to the straight philosophy and has rejected accreditation to mixer institutions. Petitioners' claim of discrimination is not substantiated. Sherman College's claim that it is substantially affected by the rule amendments is supported by the weight of evidence. Before the Board voted to discontinue allowing Sherman college graduates to take the licensure examination the college had approximately 20 students from Florida enrolled. That enrollment has dropped now to a single student out of a total of approximately 132 students. There are approximately 83 alumni of Sherman College practicing in Florida who could otherwise refer students to the college. An institution whose students are barred from practice in a state loses reputation and suffers economic loss, not just in lost tuition and fees but also through loss of donations from alumni. Sherman College receives an average of $400 per year per graduate donations. Dr. Thomas Gelardi, the president and founder of Sherman College reasonably estimates that it loses several thousand dollars a month, primarily because of the rules' impact on its enrollment.
The Issue The issue in this case is whether Respondent, Charles Leroy Mitzelfeld, D.C., committed the violations alleged in an Administrative Complaint issued by Petitioner, the Department of Health, on February 6, 2003, and, if so, what disciplinary action should be taken against him.
Findings Of Fact The Parties. Petitioner, the Department of Health (hereinafter referred to as the "Department"), is the agency of the State of Florida charged with the responsibility for the investigation and prosecution of complaints involving chiropractic physicians licensed to practice in Florida. Respondent, Charles Leroy Mitzelfeld, D.C., is, and was at the times material to this matter, a physician licensed to practice chiropractic medicine in Florida, having been licensed in Florida since 1985. Dr. Mitzelfeld's license to practice has not been previously disciplined. Dr. Mitzelfeld's Practice. At the times material to this matter, Dr. Mitzelfeld operated Foundation Chiropractic (hereinafter referred to as "Foundation"), a chiropractic clinic located in West Palm Beach, Florida. Foundation employees three individuals, in addition to Dr. Mitzelfeld's wife, daughter, father, and mother.2 It is, and was at the times material to this matter, Dr. Mitzelfeld's practice to open the offices of Foundation between 5:15 a.m. and 6:00 a.m. each day the clinic was open.3 Dr. Mitzelfeld opened the clinic early in order to see patients who needed adjustments prior to reporting to their jobs. Once Dr. Mitzelfeld unlocked the front door at Foundation, the door remained unlocked and open to the public. After Dr. Mitzelfeld unlocked the front door and before staff arrived, whenever anyone arrived at Foundation and opened the front door, a buzzer or bell sounded to announce their arrival. Dr. Mitzelfeld established and maintained an "open- door" policy at Foundation. Pursuant to this policy, the doors to all of the treatment rooms at Foundation remained open at all times and staff were allowed to enter a treatment room at any time. Dr. Mitzelfeld did not as a matter of course, however, have a staff member present whenever he was seeing a female patient. The evidence failed to prove that, even though the front door of Foundation was unlocked at all times relevant to this matter and Dr. Mitzelfeld maintained an open-door policy, Dr. Mitzelfeld could not have from engaged in the conduct described in this Recommended Order. Dr. Mitzelfeld's Treatment of Patient C.H. On or about September 6, 2001 Dr. Mitzelfeld began treating patient C.H. C.H., a female, earned a bachelor's degree in political science in 1992, and was, therefore, in all likelihood in her 30's during the times relevant to this matter. During the period of time that Dr. Mitzelfeld was treating C.H., he was also treating C.H.'s husband.4 From the time that C.H. began coming to Foundation until approximately January of 2002, C.H. was seen by Dr. Mitzelfeld during the afternoon, when staff and other patients were present. Most often, her appointments were at approximately 3:00 p.m. In approximately January 2002 C.H.'s appointment time was moved, at her request, to the early morning, before staff arrived. C.H. began arriving at approximately 6:30 a.m. for treatments and, although on occasion there were one or two individuals in the waiting room, she usually saw no one else at Foundation other than Dr. Mitzelfeld during her appointments. After C.H. began seeing Dr. Mitzelfeld in the early morning, their relationship began to change from that of a purely doctor-patient relationship to a more personal one. Their conversations started to become more personal and, gradually, they became verbally flirtatious. For example, Dr. Mitzelfeld began to tell C.H. that she was pretty and that she looked good in whatever she was wearing. Dr. Mitzelfeld's personal comments were welcomed by C.H. She responded by telling him personal things about her life, telling him that her marriage was "terrible," that her husband no longer slept in the same room with her, and that they no longer had sexual relations. Dr. Mitzelfeld's comments to C.H. continued to become more flirtatious and suggestive. Among other things, he told her that he found her attractive and that he could not understand why her husband did not find her attractive and desirable. He also told her that, if her were married to her, "I would treat you so good and I would definitely be sleeping in the same bed with you and I'd be making love to you every night." Lines 11-14, Page 69, Transcript of June 19, 2003. As C.H. and Dr. Mitzelfeld became verbally flirtatious, C.H. began to perceive that the manner that Dr. Mitzelfeld touched her was no longer just professional, but more personal and intimate, a change she welcomed. The change in their relationship was not unwelcome to C.H. C.H. believed, without having discussed the matter directly with Dr. Mitzelfeld, that they "had a relationship" and that she "was in love with him and [she] thought he was in love with [her]." Lines 22-24, Page 67, Transcript of June 19, 2003. C.H. naively believed that the physical lust they were experiencing, amounted to something more emotionally meaningful. In approximately February 2002 Dr. Mitzelfeld told C.H. that he wanted to give her a hug after her treatment. They hugged and he kissed her on the cheek. After that, they hugged after each visit. Over time, their hugs became more lasting and intimate, with Dr. Mitzelfeld eventually becoming aroused to the point where he had an erection and "he would rub it all over [C.H.]." Lines 11-12, Page 70, Transcript of June 19, 2003. Dr. Mitzelfeld began performing a new treatment on C.H. for her upper back where she held her arms out to the side, he lifted her up from behind, and her body rested against his. Dr. Mitzelfeld would become aroused during these treatments; his penis would become erect.5 The increased intimacy between C.H. and Dr. Mitzelfeld, was not unwelcome to C.H., because". . . it was very obvious we were very attracted to each other and there was chemistry." C.H. was "happy about it. I mean, I was attracted to him so it didn't bother me at all." Lines 14-15, Page 70, Transcript of June 19, 2003. On May 9, 2002, during a prolonged hug, C.H. kissed Dr. Mitzelfeld on the cheek, then quickly on the mouth, and then passionately on the mouth, a kiss which Dr. Mitzelfeld returned. C.H. continued to naively believe that she was in love with Dr. Mitzelfeld and, although he had not said so, that he was in love with her. She took time prior to each visit to look as good as she could, doing her hair, nails, and make-up, and carefully selecting what she would wear, all in an effort to please Dr. Mitzelfeld and further the relationship she believed they had. On May 13, 2002, C.H. saw Dr. Mitzelfeld for the first time after the May 9th kiss. During this visit, Dr. Mitzelfeld told C.H. that they should not let anything like the kiss happen again "because if it does, [my] hands are going to start traveling and [your] clothes are going to come off." C.H.'s next visit was the morning of May 16, 2002. After receiving her adjustment, C.H. and Dr. Mitzelfeld began hugging and kissing passionately. Dr. Mitzelfeld put his hand down C.H.'s jeans and she began to rub his penis through his clothes with her hand. After a while, C.H. told Dr. Mitzelfeld that she "wanted to do something to him" although she did not specify what. Dr. Mitzelfeld took her by the hand and led her into a bathroom, locking the door behind them. Given the circumstances, Dr. Mitzelfeld correctly assumed that what C.H. wanted to do to him was sexual. Once in the bathroom, they continued to hug and kiss while she attempted to pull down his pants so that she could perform fellatio on him. He eventually pulled his pants down for her and C.H. began to fellate him. While she did, Dr. Mitzelfeld told her to "take it deep, baby." C.H. caused Dr. Mitzelfeld to have an orgasm, after which he told her repeatedly how much he had enjoyed it. She told him that next time she would bring whipped cream. Eventually, Dr. Mitzelfeld, having been sexually satisfied, realized the possible consequences of what had happened and told C.H. that what had just happened should not have; and that he had a great marriage and that he loved his wife. Dr. Mitzelfeld became cold and distant. Dr. Mitzelfeld knew that what had happened was unethical. C.H. left Foundation upset and, because of Dr. Mitzelfeld's comments and cold treatment of her, she spoke with a neighbor and her mental health counselor and told both what had happened. Her mental health counselor told her that what had happened was unethical and that she should report it. C.H., however, was not yet realized that Dr. Mitzelfeld did not have deep emotional feelings for her. By the next morning, May 17, 2002, C.H. had recovered from her concern over Dr. Mitzelfeld's reaction the day before and convinced herself that they indeed had a relationship. C.H. naively believed that Dr. Mitzelfeld had to have feelings for her because they had engaged in a sexual act. She decided to surprise him with an unscheduled visit to his office. C.H. dressed in a black negligee which she covered with a denim dress. She entered Foundation at approximately 6:30 a.m. She did not sign in upon arrival,6 which she normally did when she arrived for a scheduled appointment. She had not come to Foundation that morning for any medical treatment. Dr. Mitzelfeld, who was upstairs in his loft-like office, came downstairs to see who had come in and met C.H.. When he asked what she was doing there that morning, she told him she had something to show him, walked up the stairs to his office, taking off her dress as she went and leaving it on the stairs, and waited for him wearing only the negligee and black high- heeled shoes. She intended to engage in sexual intercourse with him. When Dr. Mitzelfeld came into his office and saw C.H. standing there, he told her that they could not do anything like they had done the day before. Dr. Mitzelfeld had realized that what he had done was unethical and he told C.H. so. He also told her that he could be in trouble for the incident, a prophetic comment. Dr. Mitzelfeld also told her that they could not kiss, hug, or have any other sexual contact again. Dismayed and confused, C.H. dressed, as Dr. Mitzelfeld instructed her, and left the Foundation, never to return. Later the same day, Dr. Mitzelfeld discussed C.H. with a colleague, Dr. Robert McLaughlin. Dr. Mitzelfeld asked Dr. McLaughlin for advice about what he should do about a patient, C.H., who had become agitated when he rejected her sexual advances. Dr. McLaughlin correctly advised Dr. Mitzelfeld that he should discontinue any doctor-patient relationship with C.H., an act which Dr. Mitzelfeld should have taken earlier when his relationship with C.H. started to become more than just a doctor-patient relationship.7 Dr. Mitzelfeld did not admit the events found is this Recommended Order to Dr. McLaughlin. Upset, disappointed, and angry about her May 17, 2002, visit with Dr. Mitzelfeld, C.H. reported the foregoing incidents to the Department on May 22, 2002, after finally realizing that her relationship with Dr. Mitzelfeld was based upon lust and not some deeper emotional feeling. The Department's Administrative Complaint and Dr. Mitzelfeld's Request for Hearing. On February 6, 2003, after investigating C.H.'s allegations, the Department filed a one-count Administrative Complaint against Dr. Mitzelfeld before the Board alleging that he had committed "sexual misconduct" in the chiropractic physician-patient relationship, which is prohibited by Section 460.412 and, therefore, that he had violated Section 460.413(1)(ff), which provides that "[v]iolating any provision of this chapter or chapter 456, or any rules adopted pursuant thereto" constitutes a ground for disciplinary action. On or about March 18, 2003, Dr. Mitzelfeld, through counsel, filed a Petition for Formal Proceedings, indicating that he disputed the allegations of fact contained in Count I of the Administrative Complaint and requesting a formal administrative hearing pursuant to Section 120.569(2)(a). On March 19, 2003, the matter was filed with the Division of Administrative Hearings, with a request that an administrative law judge be assigned the case. The matter was designated DOAH Case No. 03-0946PL and was assigned to the undersigned. C.H.'s Legal Name. At the times relevant to this proceeding and up until May 21, 2003, C.H.'s legal name was S.C.H.H. The "C" in her legal name and the last "H" are the same names in "C.H.," the name that she has gone by during the times material to this case and throughout this proceeding. When sworn in during her deposition in this matter on May 13, 2003, rather than stating that her name was S.C.H.H. she stated that her name was C.H. She did so simply because she has always gone by the name C.H. The evidence failed to prove that, because of her technical error, her testimony in this matter was not believable. On May 21, 2003, C.H.'s name was changed to C.S.L. as a result of her divorce. Throughout this proceeding, including when she was sworn in on June 19, 2003, to testify at the final hearing of this matter, she indicated that her name was C.H. Again, it is concluded that her technical error was insufficient to conclude that her testimony in this matter was not believable. C.H.'s Use of Prescription Medicines. At all times material to this matter, C.H. was seeing a mental health counselor. The evidence failed to prove why C.H. was seeing a mental health counselor. C.H. was prescribed and has taken Wellbutrin, Adderall, and Serzone. She also was prescribed and took Zolof for a period of two months. While these drugs, taken singly or in combination may have serious side effects,8 including hallucinations, the evidence failed to prove that C.H. had any such side effects. While C.H. admitted taking the drugs in question, the evidence failed to prove that she took them during the times at issue in this matter or, if she did, what dosage she took them in. Finally, while the evidence proved that C.H. has suffered from a number of maladies, the evidence failed to prove whether she was suffering from those maladies between September 6, 2001, and the date of C.H.'s testimony at final hearing or that any of her medical problems affected in any way her memory or truthfulness in this proceeding.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the a final order be entered by the Board of Chiropractic Medicine finding that Charles Leroy Mitzelfeld, D.C., has violated Section 460.413(1)(ff), by violating Section 460.412, as alleged in Count 1 of the Administrative Complaint; suspending Dr. Mitzelfeld's license to practice chiropractic medicine for a period of three months from the date the final order becomes final; requiring the payment of a $1,000.00 administrative fine within a reasonable time after the final order is issued; placing Dr. Mitzelfeld's license on probation for a period of two years; requiring that Dr. Mitzelfeld attend ethics courses relating to the practice of chiropractic medicine as it relates to sexual misconduct, as directed by the Board of Chiropractic Medicine; and requiring the presence of a third person during any examination and treatment by Dr. Mitzelfeld of any female patient during his probation and for a period of not less than ten years thereafter. DONE AND ENTERED this 28th day of August, 2003, in Tallahassee, Leon County, Florida. S LARRY J. SARTIN 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 August, 2003.
