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, or whether Respondent engaged in sexual misconduct while acting as a health care professional in violation of section 456.072(1)(v), Florida Statutes; and, if so, what is the appropriate sanction.
Findings Of Fact The Florida Department of Health, Board of Chiropractic Medicine, 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. Kian was a licensed chiropractic physician in the state of Florida, holding license number CH10343. He is subject to jurisdiction of the Board of Chiropractic Medicine. Dr. Kian has also been licensed to practice in the states of Kentucky and Kansas, and has practiced chiropractic medicine in Germany. Dr. Kian's current address of record is 901 West Indiantown Road, Suite 20, Jupiter, Florida 33458. He received his chiropractic degree in 2009 from Life University in Georgia. Dr. Kian operates a chiropractic clinic named Capstone Chiropractic, renting office space at that location to an acupuncturist named Kelvin Yu (Mr. Yu) and a massage therapist named Robert Lorezca (Rob). Dr. Kian has not previously been subject to disciplinary action by the Board of Chiropractic Medicine. Patient J.K. has been recently licensed as a registered nurse. At the time of the incidents alleged in this case, she was a licensed practical nurse. Patient J.K. had received chiropractic treatment from three or four different chiropractors on about 20 to 30 occasions prior to meeting Dr. Kian. Patient J.K. frequently receives treatment by Rob for muscle soreness. Rob was a friend of Patient J.K.'s family, and they have known each other for many years. Patient J.K. first met Dr. Kian after an appointment with Rob for a massage therapy session at Capstone Chiropractic. That meeting occurred months before the incident at issue. On that earlier occasion, Dr. Kian gave Patient J.K. a free chiropractic adjustment as a favor to Rob. The treatment was administered in an open area. On April 25, 2017, when Patient J.K. first entered Capstone Chiropractic, she had a brief conversation with Rob, Dr. Kian, and Mr. Yu, and they discussed that they could open a spa because they offered so many different treatment options. She discussed a chiropractic adjustment with Dr. Kian, and he indicated he would adjust her after her massage with Rob. She also had an appointment with Mr. Yu. After her massage, Dr. Kian took Patient J.K. to a table in the open room to adjust her. Although she had been undressed for the massage, she had put her clothes back on afterwards, and was fully clothed during the adjustment. Patient J.K. told Dr. Kian that she had pain in her lower back, as she frequently did, and that recently her right foot also had begun to hurt. Following the adjustment, Dr. Kian offered Patient J.K. an additional trigger point release treatment. This would involve a treatment of the hamstring and the psoas, a muscle which runs from the lumbar spine to the femur. To administer the trigger point release, Dr. Kian was to perform a deep massage of the affected areas. Patient J.K. asked Dr. Kian if the trigger point release massage required skin-on-skin contact, and Dr. Kian told her it did. She returned to the private massage room she had been in earlier with Rob. She undressed completely and lay face down on the massage table, covered by a sheet. When Dr. Kian returned, they were the only persons in the room. When Patient J.K. was on her stomach, Dr. Kian lifted the sheet to massage her hamstrings. Patient J.K. could feel that the sheet was "pulled all the way off," exposing her buttocks, so she pulled the sheet back to cover herself. Dr. Kian then readjusted the sheet "halfway" and proceeded to massage Patient J.K.'s hamstring. When massaging Patient J.K.'s hamstring, Dr. Kian gradually moved his hand between Patient J.K.'s legs, touching her labia. When Patient J.K. was touched, she flinched away, pulled the sheet down, and said "whoa." She initially thought this first touch might have been unintentional. Dr. Kian began to work on her right foot a while, and then asked Patient J.K. to flip on to her back so that he could treat her psoas muscle. She turned on to her back underneath the sheet. Dr. Kian then moved the sheet, exposing the lower half of Patient J.K.'s body. Patient J.K. again pulled the sheet back over to cover herself. Dr. Kian then readjusted the sheet, leaving Patient J.K.'s vaginal area partially exposed. Dr. Kian then began to massage the psoas muscle, working from the outside toward the inside of her body. Dr. Kian kept moving his hand toward the center, between Patient J.K.'s legs, and he again touched her labia. Patient J.K. immediately looked up to see Dr. Kian leaning very closely over her lower body. She pulled the sheet to cover herself and said "whoa." Patient J.K. knew at that point that his exposing her and touching her was intentional because it was the second time that it had happened, and she was shocked. Dr. Kian immediately straightened up and walked up toward Patient J.K.'s head, saying he wanted to do an adjustment. He started to massage her left shoulder area, moving toward her breast. Patient J.K. told him that was okay, that was enough, and that she needed to go. Dr. Kian said, "Well, let me adjust your back, lean forward." Patient J.K. pulled the sheet under her arms and leaned forward. She did not hear any popping and so again said that it was time for her to go. Patient J.K. testified she just wanted to get out of there. She turned her legs off of the bed to sit on its edge. As soon as she leaned forward, she testified that Dr. Kian was "literally right in my face." Patient J.K. believed that Dr. Kian intended to kiss her on the lips. She turned her head to the left, and he kissed her on the cheek. Patient J.K. testified that she believed Dr. Kian would have kissed her on the lips had she not turned her head. Dr. Kian exited the room, and Mr. Yu came in immediately. Even though her mother's dental appointment was actually later in the afternoon, Patient J.K. told Mr. Yu that she had to leave to go to it and would not have time for her acupuncture treatment. She just wanted to go. As soon as Mr. Yu left, Patient J.K. dressed herself and went to the counter where Dr. Kian, Rob, and Mr. Yu were standing. She said nothing about what had happened to either Rob or Mr. Yu. She paid Rob for her massage and Dr. Kian for the adjustment. Dr. Kian was surprised by the offer to pay, but Patient J.K. insisted that he accept payment. As Dr. Shreeve testified, the scope of practice for chiropractors requires that they do not intentionally expose any genital area or any part of a patient's body that does not need to be open to the doctor's skin-to-skin contact. In treating Patient J.K., there was no need to expose her buttocks or vaginal area. As Dr. Shreeve's testimony indicated, when properly treating the psoas muscle, a chiropractor's hands would not be near the vaginal area, and there was no justification for touching Patient J.K.'s labia in her treatment. Under all of the circumstances, it is clear that Dr. Kian used the chiropractor- patient relationship to engage in sexual activity outside of the scope of professional practice by intentionally exposing Patient J.K.'s buttocks and vaginal area and intentionally touching her labia. Following the incident, Patient J.K. drove from Jupiter to her home in Vero Beach, a drive of about an hour and a half. She reflected on what Dr. Kian had done. When she arrived in Vero Beach, Patient J.K. called her brother, who was a licensed chiropractor, and told him what had happened. She also called her Aunt Mary and a family friend, who was an attorney, and asked what she should do. He told her that she needed to go to the police. She tried a couple of times to contact Rob to discuss what had happened. She was unable to communicate with Rob and then decided not to try to contact him again about the incident. Patient J.K. decided to report Dr. Kian so that he could not sexually assault another patient. Patient J.K. drove to the Jupiter Police Department on April 27, 2017, and reported the incident. An interview was scheduled for May 4, 2017, and conducted by Detective Panczak. Detective Panczak subsequently contacted the Department of Health. Patient J.K.'s testimony was clear and convincing, and she was consistent in her recollection in all major respects. Minor differences in her accounts of events reflected that she was genuine in her efforts to tell her story as accurately as possible from her memory on each occasion and did not attempt to craft or memorize a single version of events. Patient J.K. did not struggle to remember the relevant facts. While her testimony that she believed Dr. Kian intended to kiss her on the lips following the trigger point release session was credible, it is possible that Dr. Kian might have intended to kiss her on the cheek for a more benign purpose; and under all of the circumstances, it was not clearly and convincingly shown that his action in kissing her on the cheek constituted sexual misconduct. Dr. Kian denied all allegations except kissing Patient J.K. on the cheek.1/ His assertions that she was never exposed, that his hands were never close to Patient J.K.'s vaginal area, and that her body shape and positioning would have prevented exposure of her vaginal area and prevented him from touching her labia were not credible and are rejected. Revocation of Dr. Kian's professional license would have a very 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. Hamed Kian in violation of sections 456.072(1)(v) and 460.412, Florida Statutes; revoking his license to practice chiropractic medicine; and imposing costs of investigation and prosecution. DONE AND ENTERED this 27th day of July, 2018, 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 27th day of July, 2018.
The Issue Whether the allegations of the Administrative Complaint are correct, and if so, what penalty should be imposed.
Findings Of Fact An advertisement in the December 6, 1989 edition of the Beaches Shopping Guide indicated that "sculptured nail" services were available through "Debbie's Designer Nails". The advertisement contained a telephone number. In response to the advertisement, Eileen Thomas, an investigator for the Petitioner, on February 23, 1990, called "Debbie's Designer Nails" at the phone number listed in the advertisement. Ms. Thomas spoke with a woman identified as "Debbie". During the conversation, Debbie informed Ms. Thomas that manicure services were available in either the customer's home or in Debbie's home, at a cost of twelve dollars. Debbie stated that she had been offering her services for approximately three months. At the close of the conversation, Ms. Thomas, using the name "Brenda", made an appointment for a manicure at Debbie's place of business on February 27, 1990. On February 27, 1990, Geraldine Johnson, an employee of the Petitioner, arrived at the Respondent's residence and identified herself as "Brenda". The Respondent performed a manicure on Ms. Johnson, who paid the Respondent thirteen dollars for her services. While the Respondent performed the manicure on Ms. Johnson, another woman arrived at the Respondent's home. The Respondent told Ms. Johnson that the woman had an appointment for nail sculpturing. Before Ms. Johnson left the Respondent's home, the Respondent gave Ms. Johnson ten business cards and requested that Ms. Johnson distribute the cards to potential customers. The cards include the Respondent's name, the name of the business, the slogan "My House or Yours", the telephone number, and the types of manicure services available. The Respondent is not a licensed cosmetologist in the State of Florida. The Respondent's business, "Debbie's Designer Nails", is not licensed as a cosmetology salon in the State of Florida.
Recommendation Based on the foregoing, it is hereby RECOMMENDED that the Florida Board of Cosmetology enter a Final Order imposing an administrative fine of one thousand dollars on the Respondent. DONE and RECOMMENDED this 4th day of January, 1991, in Tallahassee, Florida. WILLIAM F. QUATTLEBAWM Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 4th day of January, 1991. APPENDIX CASE NO. 90-4761 The following constitute rulings on proposed findings of facts submitted by the parties. Petitioner The Petitioner's proposed findings of fact are accepted as modified in the Recommended Order except as follows: 3. The evidence did not establish that the Respondent actually placed the advertisement in the Beaches Shopping Guide. Respondent The Respondent submitted no proposed recommended order. COPIES FURNISHED: Laura P. Gaffney Senior Attorney Department of Professional Regulation Northwood Centre 1940 North Monroe Street, Suite 60 Tallahassee, Florida 32399-0792 Debbie Holcomb 5856 Wiltshire Street Jacksonville, Florida 32211 Myrtle Aase, Executive Director Board of Cosmetology Department of Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792 Kenneth E. Easley, General Counsel Department of Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792
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 The issues are whether Respondent is guilty of making or filing a false report signed in the capacity of a licensed chiropractic physician, in violation of Section 460.413(1)(j), Florida Statutes, and, if so, the penalty.
Findings Of Fact Respondent has been a licensed chiropractor in Florida since 1978, holding license number CH0002696. Petitioner requires licensed chiropractors to file Mandatory Practitioner Profile Questionnaire Packets (Profiles). The subject Profile was due on or before April 15, 1999. The Profile asks the licensee to supply various items of information and answer several questions. Section II of the Profile requires information concerning "medical education." In response to the question of what medical school Respondent attended, he wrote: "Logan 'Quack Con-Artist' School of Chiropractic." In response to the type of his degree, Respondent wrote: "Quack Con-Artist Chiropractic Degree." In response to questions concerning medical training, Respondent answered: "'Fraudulent' Automobile Personal Injury Cases (Robbing Insurance Companies)" and "'Fraudulent' Workers Compensation Cases (Robbing Insurance Companies)." Respondent also added to these responses, as well as the responses cited in the preceding paragraph, the following: "Caveat: see letter dated April 7, 1999 sent to Gloria Henderson, Division Director)." Section VIII of the Profile requires information concerning criminal offenses. This section asks: "have you ever been convicted or found guilty, regardless of whether adjudication of guilt was withheld, or pled guilty or nolo contendere to a criminal misdemeanor or felony in any jurisdiction?" The question then states: "If "YES," briefly describe the offense(s), indicate whether the conviction is under appeal, and attach copy of notice of appeal." The form supplies three lines for each of these items of information. Respondent answered "no" to the first question in Section VIII and left the remainder of the section blank. The Profile concludes, immediately above the signature line: "I affirm these statements are true and correct and recognize that providing false information may result in disciplinary action against my license or criminal penalties pursuant to Sections 455.624, 458.327, 458.331, 459.013, 459.015, 460.413, 461.013, 775.082, 775.083 and 775.084, Florida Statutes." Respondent signed on the signature line and added the date of April 7, 1999. Immediately beneath the signature line, Respondent added: "Notice: Signed under caveat--see letter dated April 7, 1999 sent to Gloria Henderson, Division Director." Respondent's four-page letter to Gloria Henderson dated April 7, 1999, references the Profile, notifies Ms. Henderson and Petitioner of Respondent's intent to sue, and demands that Petitioner omit Respondent's listing from a website of chiropractors because, in part, "I do NOT accept their 'valueless treatment' known as an "adjustment" (it is a waste of money and time), and because I practice health care from an "Allopathic" (medical approach) point of view, including but not limited to, surgery, drug prescription, physical therapy " Respondent states in the letter that the Petitioner's failure to incorporate his comments in all computer files listing him as a chiropractor will result in his filing a federal action under tort and constitutional law seeking $1 million plus punitive damages. The final caveat in the April 7 letter states: My (Roy A. Day) signature on the instant letter, and the associated completed questionnaire, reflects the denial of Roy A. Day to have meaningful access to so-called "licensed attorney" courts of law, and the associated denials of each and all discovery, and trial by jury, and the right to each and all appeals, and the denial to write a brief on appeals, and each and all associated "railroading" of Roy A. Day, with the overlay for "licensed attorney" courts of law to deny the law, facts and evidence existed when they pertained to Roy A. Day, since Roy A. Day is not represented by a so-called "licensed attorney" at $300.00 per hour in artificial-monopolistic legal fees. In addition, the signature reflects each and all associated "forced and coerced" action, specifically, Roy A. Day has been denied "due process and equal protection of the law." On February 6, 1995, Pinellas County Circuit Court entered an Order of Probation. The Order states that Respondent pleaded guilty to aggravated stalking, interception of oral communication, and uttering a check with a forged endorsement. The Order withholds adjudication and places Respondent on probation for two years. As a result of Respondent's violation of the conditions of probation, on September 20, 1996, Pinellas County Circuit Court entered a judgment finding Respondent guilty of two counts of the third-degree felony of uttering a check with a forged endorsement, in violation of Section 831.02, Florida Statutes. The checks totaled approximately $20,000, and, sometime between March 13 and May 5, 1993, Respondent passed each check knowing that the signature of his brother, Donald Day, was forged. For each count, the court sentenced Respondent to one year in jail with credit for 130 days he had already served in jail, and the sentences ran concurrently. As a result of Respondent's violation of the conditions of probation, on September 20, 1996, Pinellas County Circuit Court entered a judgment finding Respondent guilty of the third-degree felony of aggravated stalking, in violation of Section 784.048(3), Florida Statutes. The stalking consisted of repeated and harassing telephone calls that Respondent made to the house of a person who had, at one time, expressed interest in purchasing a home in which Respondent had an interest, but later decided not to pursue the purchase. The court sentenced Respondent to one year in jail with credit for 133 days that he had already served in jail, and this sentence ran concurrently with the sentences for uttering a check with a forged endorsement. Petitioner lacked a copy of a judgment concerning the interception of oral communications. This offense arose out of Respondent's surreptitious recording of a conversation that he had with a police officer who was investigating the stalking charges. Absent a copy of the judgment, however, insufficient evidence of this conviction exists for the purpose of this disciplinary case. At the final hearing, Respondent explained that he did not disclose these criminal convictions on the Profile because doing so would somehow implicate him as a "co-conspirator" in the injustices perpetrated upon him by the authorities involved in prosecuting these offenses. Respondent falsely failed to disclose on the Profile his convictions for aggravated stalking and uttering a check with a forged instrument. His failure to disclose this information constitutes fraudulent concealment of these criminal offenses. In a fairly straightforward case, Respondent has filed nearly 250 pleadings containing thousands of pages. He also abused the subpoena power of this tribunal by subpoenaing judges and court officials from every level of the federal and state judiciaries. Last but not least, Respondent has defamed and discredited numerous persons without apparent reason, although some question exists whether Respondent is capable of exercising consistent control over the impulses leading to at least some of these utterances. The crimes of which Respondent was convicted may have arisen out of family disagreements, possibly concerning the sale of a family home. Respondent may be obsessively preoccupied with actual or perceived injustices that he suffered as a result of this transaction. Undoubtedly, Respondent compulsively litigates everything that has the most remote bearing upon this transaction, using court files as archives for materials that he believes will vindicate him, despite an ardent and often- expressed repulsion for judges, lawyers, and others connected with the legal system. No penalty but revocation is suitable under the circumstances, absent a showing by Respondent that he has commenced or is continuing therapy and that the prognosis is reasonably good. The record lacks such evidence. Respondent is not unintelligent, nor is he entirely devoid of insight. His thinking, although at times disordered, is capable of impressive organizational efforts, as best revealed by his meticulous organization in his proposed recommended order of what otherwise seemed to be a bewildering variety of materials that Respondent has seen fit to file in this case. Although his behavior seems at times compulsive, Respondent was capable of a certain level of self-restraint, at least during the hearing and when not directly confronting the underlying transaction or crimes. If they occur at some point in the future, successful diagnosis and treatment of Respondent should inform Petitioner's interpretation of the events and behaviors described in this Recommended Order, if Respondent seeks relicensure as a chiropractor.
Recommendation It is RECOMMENDED that the Board of Chiropractic Medicine enter a final order finding Respondent guilty of violating Section 460.413(1)(j), Florida Statutes, and revoking his license. DONE AND ENTERED this 19th day of July, 2001, in Tallahassee, Leon County, Florida. ROBERT E. MEALE 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 19th day of July, 2001. COPIES FURNISHED: Joe Baker, Jr. Executive Director Board of Chiropractic Medicine 4052 Bald Cypress Way, Bin C07 Tallahassee, Florida 32399-1701 Theodore M. Henderson Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Wings S. Benton, Senior Attorney Agency for Health Care Administration Office of General Counsel Medical Quality Assurance Practitioner Regulation--Legal Post Office Box 14229 Tallahassee, Florida 32317-4229 Roy A. Day Post Office Box 33 Tarpon Springs, Florida 34688-0033
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.
