Findings Of Fact At all times relevant hereto, the Respondent, Michael F. Petrie, was licensed as a chiropractic physician by the Florida Board of Chiropractic. The Petitioner introduced no evidence relating to Count I of the Administrative Complaint. On or about February 3, 1982, the Respondent placed an advertisement in the Pompano Shopper's Guide, advertising the Petrie Chiropractic Life Center. (See Joint Exhibit 1.) This advertisement states, in pertinent part, ". . . To take a pill or more each day is dependency. Dependency is addiction! Whether these drugs are pushed or prescribed, you are an addict! CHIROPRACTIC can many times free you from drug dependency. . ." The advertisement makes reference to specific medical conditions, such as headaches, diabetes, stroke, high blood pressure and skin problems, which can be helped by chiropractic treatment. The testimony of Kenneth C. Lasseter, M. D., was offered via deposition as Petitioner's Exhibit 2. Dr. Lasseter stated his professional opinion that dependency on a drug is not the same as addiction. Drs. Michael Nathanson, Thomas Pasterski and Richard Hodish, all of whom are doctors of chiropractic and were accepted as experts in this field, testified that addiction and dependency are synonymous. (See Transcript, pages 48, 49, 95 and 101.) Their testimony was further substantiated by the definitions of addiction and dependency as found in the Encyclopedia and Dictionary of Medical and Nursing. Joyce Quintavalli, R. N., a psychiatric nurse specializing in the treatment of young people for drug problems, stated that from the practical standpoint there was no difference between dependency and addiction. Dependency and addiction are synonymous. Robert S. Butler, Jr., D. C., who was accepted as an expert in chiropractic, testified that the advertisement indicated that the Respondent's treatment could reduce a patient's need for medication for the enumerated conditions or illnesses and therefore opined that the advertisement was misleading. However, Dr. Butler stated that the medical conditions enumerated in the advertisement fall within the scope of practice of chiropractic, that chiropractic can treat patients for these problems with good results, and that treatment can lessen or free the patient from drug dependency. Dr. Butler stated his concern that the advertisement could encourage people to stop their medications, although he admitted that the advertisement does not urge or recommend to people that they cease taking medication. The chiropractic physicians enumerated in Paragraph 5 above testified that the conditions enumerated in the advertisement were within the scope of treatment of chiropractic, that they had treated patients for these diseases or conditions with good results, and that as a result of treatment their patients had reduced or ceased altogether taking medication which had been necessary prior to their treatment for control of their condition. The statements made in the advertisement are accurate and do not mislead the public concerning the scope of chiropractic, the benefits of chiropractic, or the Respondent's qualifications.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Administrative Complaint filed against Michael F. Petrie be dismissed. DONE and RECOMMENDED this 15th day of April, 1983, in Tallahassee, Leon County, Florida. STEPHEN F. DEAN, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 15th day of April, 1983. COPIES FURNISHED: Jerry Frances Carter, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Michael F. Petrie, D. C. 410 NE 44th Street Fort Lauderdale, Florida 33334 Frederick Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Jane Raker, Executive Director Board of Chiropractic Examiners 130 North Monroe Street Tallahassee, Florida 32301
Findings Of Fact The Respondent, Peter P. Alongi, is a licensed chiropractic physician, practicing in Fort Lauderdale, Florida. An administrative complaint was filed by the Petitioner, Florida State Board of Chiropractic Examiners, dated December 7, 1978, alleging that the Respondent engaged in deception, misrepresentation or fraud by publishing a certain advertisement. An administrative hearing was requested by the Respondent. Thereafter, a motion to dismiss was filed by the Respondent prior to the formal hearing, which was denied. Respondent Alongi casued the following advertisement to be published in the Fort Lauderdale News in the month of May 1978: CHIROPRACTORS SEEK RESEARCH VOLUNTEERS The International Pain Control Institute is presently engaged in what is the most expensive research program ever undertaken by the chiropractic profession. This research is directed toward determining the relationship between health problems and spinal misalignment and utilizes a screening process called contour analysis. Volunteers are being sought for screening. Contour analysis enables taking a 3 dimensional picture (called moire photography) of the topography of the surface of the spine to detect spinal stress deviations. This analysis will be correlated with leg deficiency, patient sympto- matically and levels of spinal tenderness. An analysis of this type can reveal such things as normal and abnormal stress patterns, spinal curvature, muscle spasm, muscle imbalance, spinal distortion and scoliosis. This is a Public Service Program for partici- pating volunteers. The doctors are contributing their time, service and facilities for the program. Anyone wishing to be a volunteer may telephone participating doctors directly for information or an appt. Dr. Peter P. Alongi Dr. Larry Burch 2821 E. Commercial Boulevard 200 SE 12 St. Ft. Laud. Ft. Laud. 491-2449 764-0444 Ms. Laura Borys read the foregoing advertisement and, thinking there would be no charge for treatment, made an appointment with Respondent Alongi. Ms. Borys had interpreted the advertisement to mean that if she presented herself as a "research volunteer" there would be no cost to her. Ms. Borys was accompanied to Respondent Alongi's office by Ms. Katherine Leight, a sister-in- law of Ms. Borys. Ms. Leight had told Ms. Borys that she felt the advertisement was soliciting for paying customers, and that she based her view on the reason that she had never seen such an advertisement by any other chiropractor. Ms. Borys would not have made the appointment with Respondent Alongi to participate as a volunteer pursuant to said advertisement if she had know that x-rays and chiropractic treatment would be on a cost basis. Respondent Alongi performed a contour analysis and gave Ms. Borys a photograph of her back. The Respondent analyzed the photograph and advised Ms. Borys that she had a back problem, and that for a fee of $50.00 she could have x-rays taken and would be charged $15.00 per visit for treatment. Upon a close reading of the foregoing advertisement it is not likely that the general public would have been mislead into believing that free treatments or x-rays would be given. Ms. Borys' sister-in-law, Ms. Leight, did not believe the advertisement was inserted for any other reason than to solicit business for the two doctors included in said advertisement. No questions were raised or evidence submitted as to what constituted the "research program" other than the taking of the picture of the back, or whether members of the public were deceived or mislead into thinking that there was in fact a valid program. Both parties submitted proposed recommended orders. These instruments were considered in the writing of this order. To the extent the proposed findings of fact have not been adopted in, or are inconsistent with, factual findings in this order they are specifically rejected as being irrelevant or not having been supported by the evidence.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, the Hearing Officer recommends the Administrative Complaint be dismissed. DONE AND ORDERED in Tallahassee, Leon County, Florida, this 10th day of July, 1979. COPIES FURNISHED: Paul W. Lambert, Esquire 1311 Executive Center Drive Suite 201, Ellis Building Tallahassee, Florida 32301 Thomas F. Panza, Esquire 2803 East Commercial Boulevard Fort Lauderdale, Florida 3308 DELPHENE C. STRICKLAND Hearing Officer Division of Administrative Hearings Collins Building Tallahassee, Florida 32301 (904) 488-9675
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 Should discipline be imposed against Respondent's license to practice chiropractic medicine for violation of Section 456.072(1)(c), Florida Statutes (2003)?
Findings Of Fact Facts Established by Admission Effective July 1, 1997, Petitioner is the state agency charged with regulating the practice of chiropractic medicine pursuant to Section 20.43, Florida Statutes. Petitioner is the state agency charged with regulating the practice of chiropractic medicine pursuant to Chapters 456 and 460, Florida Statutes. Respondent is and has been at all times material hereto a licensed chiropractic physician in the State of Florida, having been issued license number CH 5396 on October 14, 1986. Respondent's last known address is 9471 Baymeadows Road #108, Jacksonville, Florida 32256-0154. JHCS operated as a medical clinic offering and supplying chiropractic and medical services to patients. Respondent caused or allowed claims to be filed with Medicare and other health care benefit programs claiming reimbursement for the professional component of Magnetic Resonance Imaging tests (MRI). The report generated as a result of the outside radiologist was placed onto JHCS' letterhead to give the appearance that the radiologist was an employee of JHCS and Respondent. Respondent pled guilty to crimes that occurred in the course of Respondent's practice of chiropractic medicine (during his hours of operation). For Diagnostic Ultrasound (DU) and Nerve Conduction Velocity (NCV) billing, Respondent submitted claims for the technical portion of DU or NCV test, which is the performance of the test, even though Respondent did not contribute his professional expertise to the performance of the test. Respondent would submit claims to various health care benefit programs for the technical component of the test. Additional Facts In United States of America v. Mark Schoenborn, United States District Court, Middle District of Florida, Jacksonville Division, Case No. 3:03-cr-315-J-25MMH, Respondent pled guilty to Count 1 of the information, 18 U.S.C. §§ 1347 and 371. The nature of the offense was conspiracy to defraud a health care benefit program. The offense ended September 2002. The judgment in the criminal case held to the following effect: The defendant is sentenced as provided in pages 2 through 5 of this judgment. This sentence is imposed pursuant to the Sentencing Reform Act of 1984, as modified by United States v. Booker. At page 4 of 5 the obligation for restitution is set forth as part of the sentence. A sentence was imposed in the case on February 11, 2005, in which Respondent was placed on probation, for a term of three years. A special condition of supervision was that Respondent participate in the Home Detention Program for a period of six, assumed to be months, and that he perform 100 hours of community service. Respondent was required to pay a $10,000.00 fine and to make $400,000.00 in restitution. The payees in the restitution were: Aetna, Inc., $52,944.00; United Health Group, $38,076.00; DHHS/CMMS, Division of Accounting, $245,609.00; and Blue Cross/Blue Shield of Florida, $63,371.00. Respondent would receive credit for all payments previously made toward any criminal monetary penalties imposed on a joint and several basis with Respondent Charles Doll, United States District Court, Case No. 3:03-cr-314-J-25MMH. Respondent has referred patients for MRIs to provide information about soft tissue in relation to the formation of a disc. In particular, the information about the disc would pertain to a herniated or bulging disc. The information imparted in the MRI results assists in diagnosing a patient, according to Respondent. It is not involved with the treatment of the patient. The initial diagnosis is made without the benefit of an MRI. Respondent refers patients for NCV tests, the results of which may show nerve pressure, according to Respondent. The diagnosis will have been formulated before the referral is made usually. This special test assists in further understanding "things going on with a patient." The results of the test could further assist Respondent in rendering care. Respondent has used DU in his practice. The information provided by those tests is a showing of inflammation in an area. The results help Respondent decide what to do with a patient, as far as additional treatment, and whether there may be the need to make a referral outside his practice or some other choice. In making the referrals that have been described, Respondent believes that he is making that choice as a chiropractic physician. Expert Opinion Michael William Mathesie, D.C., is licensed to practice chiropractic medicine in Florida. He is an expert in the field of chiropractic medicine. Petitioner hired Dr. Mathesie as its consultant in the case, to express an opinion concerning Respondent's practice in view of the allegations in the Administrative Complaint. In Dr. Mathesie's opinion the practice of chiropractic medicine consists of diagnosis and treatment of nerves, muscles, joints, and conditions of the spine and extremities. Diagnosis of a patient would consist of inspection and palpation, range of motion, orthopedic maneuvers, neurological evaluations, X-rays, CT scans, MRIs, neurological diagnostic testing, and other specialized tests, as well as blood laboratory evaluations. Treatment would consist of adjustments to the spine to correct subluxations, or other lesions of the spine causing nerve irritation or impulses or nerve transmission problems. Physical therapy modalities, nutrition, counseling and other non- pharmaceutical and non-neurological procedures are also involved. Dr. Mathesie explained the use of diagnostic testing in the practice of chiropractic medicine. If a patient has a long- standing condition of the spine or extremities, such as nerve pain shooting down the arm or numbness or tingling, a NCV test might be run, but the test may not be used on a regular basis for reasons other than the evaluation of the patient's condition. To do so would skew the diagnostic abilities of the chiropractic physician, according to Dr. Mathesie. Chiropractors are taught diagnostic testing and evaluation in chiropractic school. In his practice Dr. Mathesie bills for his services rendered to the patient in accordance with Section 460.41, Florida Statutes. Jan Allen Fralicker, D.C., was called as an expert to testify in behalf of Respondent Schoenborn. Dr. Fralicker is licensed in Florida to practice chiropractic medicine. In addressing the allegations in the Administrative Complaint directed to Respondent Schoenborn of a violation of Section 456.072(1)(c), Florida Statutes, and equally applicable to Respondent Doll, Dr. Fralicker does not believe that the allegations pertain to the practice of chiropractic medicine. Dr. Fralicker explains that the practice of chiropractic medicine in Florida is the diagnosis and treatment of human elements without the use of drugs or surgery, to include diagnostic testing. The crime to which Respondent Schoenborn pled and Dr. Doll pled, involves fraud in the criminal aspect, according to Dr. Fralicker, for receiving money for services not performed. The criminal activity did not actually involve Respondent's functioning as a chiropractor related to patients being treated. In Dr. Fralicker's opinion ordering the tests involved in the case, as Dr. Fralicker understands it, was the practice of chiropractic medicine, but defrauding a health care benefit program is not related to the practice of chiropractic medicine. Nothing about Dr. Fralicker's understanding of the criminal law matter involved a standard of care issue. Dr. Fralicker separates the criminal activity from the practice of chiropractic medicine. In summary, while ordering diagnostic tests is part of chiropractic medicine, pleading guilty to defrauding a health care program is not, in the view of Dr. Fralicker. What Respondents were engaged in was practicing chiropractic and then separately involving themselves in criminal activity to defraud, i.e. getting paid for something not being done. Dr. Fralicker is familiar, as a chiropractic physician, with submitting billing to be reimbursed for services as a chiropractic physician. He submits requests for reimbursement. The submission of requests for reimbursement is seen by Dr. Fralicker as part of the practice of chiropractic medicine. Dr. Fralicker believes that chiropractors providing a service must meet the standards of what the general population of chiropractors would do in the area where they practice, involving appropriate diagnosis and referral to another professional, if necessary, for additional treatment. He does not believe that the Respondents violated the professional standards. Neither opinion of the experts is persuasive, beyond its value in establishing the nature of the practice of chiropractic medicine in delivering care and billing for the services provided. Dr. Schoenborn Previous Disciplinary History In the case Agency for Health Care Administration, Petitioner v. Mark E. Schoenborn, D.C., Respondent, before the State of Florida, Agency for Health Care Administration, Board of Chiropractic, Case No. 9207885, and related cases, Respondent was charged in Count 1 with a violation of Section 460.413(1)(m), Florida Statutes, formerly Section 460.413(1)(n), Florida Statutes, for failing to maintain written chiropractic patient records that would justify the course of treatment of the patient. In Count II to that Administrative Complaint Respondent was charged with violating Section 460.413(1)(i), Florida Statutes, by failing to perform a statutory or legal obligation of the licensed chiropractic physician in performing, ordering, administering or procuring unnecessary diagnostic testing in violation of Section 766.111, Florida Statutes. In Count III to the Administrative Complaint Respondent was charged with a violation of Section 460.413(1)(r), Florida Statutes, formerly Section 460.413(1)(s), Florida Statutes, by failing to practice chiropractic at the level of skill, care, and treatment which is recognized by a reasonably prudent chiropractic physician as being acceptable under similar conditions and circumstances. In Count IV of the Administrative Complaint Respondent was charged with violating Sections 460.413(1)(b), Florida Statutes, and 460.413(1)(v), Florida Statutes, formerly 460.413(1)(w), Florida Statutes, and Florida Administrative Code Rule 61F2- 5.001(2), formerly Florida Administrative Code Rule 21D-5.0012, by engaging in false deceptive or misleading advertising. The parties entered into a settlement stipulation which was approved by final order, in relation to Case Nos. 9207885 and 9216199, 94- 05484 and 94-11080. Ultimately the stipulation that was approved in a final order entered February 13, 1996, was to the failure to maintain written chiropractic patient records that would justify a course of treatment to the patient, a violation of Section 460.413(1)(m), Florida Statutes, that had been referred to as Section 460.413(1)(n), Florida Statutes. As a consequence Respondent paid $3,000.00 in administrative costs, had to take a course on records keeping, and was required to have his patient records monitored.
Recommendation Based upon the consideration of the facts found and the conclusions of law made, it is RECOMMENDED: That a final order be entered finding a violation of Section 456.072(1)(c), Florida Statutes (2003), and revoking Respondent's license as a chiropractic physician. DONE AND ENTERED this 16th day of March, 2006, in Tallahassee, Leon County, Florida. S CHARLES C. ADAMS 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 16th day of March, 2006. COPIES FURNISHED: Ephraim D. Livingston, Esquire William Miller, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Roy Lewis, Esquire 203 Washington Street Jacksonville, Florida 32202 Joe Baker, Jr., Executive Director Board of Chiropractic Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
Findings Of Fact Mrs. Carol Ann Carter's daughter, Suzanne, had passed out at school a few times and, when routine medical checks failed to disclose the specific cause, Mrs. Carter thought a pinched nerve might be the problem. She took Suzanne to Dr. Dappolonia, a chiropractor, whose name was suggested by a friend. Medical doctors had indicated more drastic tests would he required to ascertain the cause of the problem and, before embarking on those tests, Mrs. Carter decided to try the services of a chiropractor. On her first visit Dr. Dappolonia took x-rays of the patient and explained to Mrs. Carter that he could diagnose Suzanne's problems with his biometer machine. Mrs. Carter expressed her skepticism to Dr. Dappolonia when he advised her that the machine could diagnose the condition of all body organs. When she told him she didn't want to he ripped off he assured her that the machine was all he claimed it to be. When Dr. Dappolonia examined Suzanne by use of the biometer he advised her and Mrs. Carter that she had five hundred million units of infection in her nervous system and prescribed pills to be taken at frequent intervals - initially 5 every 15 minutes for one hour then 5 per hour. He further advised that these pills were unique in that if touched by human hands they would be neutralized and would not be effective thereafter. Then told this Mrs. Carter again expressed her skepticism, but Dr. Dappolonia assured her that the treatment and medication would cure her daughter's malady. During the course of these treatments Dr. Dappolonia told Suzanne and Mrs. Carter that it was necessary to believe in the machine and the pills in order for them to work. Suzanne received some seven or eight treatments from Dr. Dappolonia which consisted of checks by use of the biometer and continuation of the Celoid pills. On the last visit Mrs. Carter was advised that Suzanne was now suffering from insecticide poisoning and that a different Celoid pill would be needed. He prescribed for her some of these pills. Mrs. Carter took these pills to her family doctor, Dr. Miller, who sent them to a laboratory far analysis. The pills contained none of the ingredients normally found in medicines and were physically similar to certain sugar pills carried in pharmacies for use as placebos. Chemical tests conducted showed the pills consisted principally of dissacherides, either lactose or maltose, and contained no ingredient normally used to combat insecticide poisoning. Dr. Miller was advised of the results of the laboratory tests. During the various visits Suzanne made to Dr. Dappolonia the biometer was used on each visit. Suzanne and Mrs. Carter described the machine as having the outward appearance of an old radio with several knobs which could be turned but no meters or recording devices which had needle or stylus that moved. A black 4" x 4" x 1/3" black plate with two wires attached would be placed an the body and Dr. Dappolonia, with his fingers on the plate, would turn dials on the machine and thereafter announce the amount of infection in the organ. Dr. Gary Miller has treated Suzanne Carter off and on since 1973 as the family doctor. In January, 1975 she was examined by him following a syncopal episode (fainting). This examination revealed no physical abnormality that would account for the episode. She was advised to keep a running record of these episodes if they recurred. Dr. Miller saw Suzanne in February, 1975 with no reported recurrence of syncopol episodes. He saw her again in May, 1975 when several intervening episodes were reported. At this time he conducted an electroencephalogram which was normal. Suzanne was next seen on June 3, 1975 for pain in her right elbow which had been bruised in a fall. At this time Mrs. Carter asked him to have pills analyzed and to check Suzanne for insecticide poisoning. He saw no symptoms of such poisoning and suspected that the pills were placebos. When he received the report from the laboratory that the pills were composed of dissacherides he considered his suspicions confirmed. In any event the pills would have had no therapeutic value in treating insecticide poisoning. Dr. Miller has had special training in several fields of medicine including internal medicine, is unaware of any machine that can measure infection, and he has never heard of a machine as described by Suzanne and her mother used in any field of medicine. Homer S. Stallings, D. C. is a licensed chiropractor and former member of the Board of Chiropractic Examiners. As such he is generally familiar with the curriculum and the schools that are approved by the Florida Bond of Chiropractic Examiners that will qualify a graduate to be admitted to practice in Florida. He is aware of none that teach the use of any particular instrument to diagnose infections. Chiropractors cannot prescribe medications; however, naturopath are permitted to do so. At the completion of the Board's case Respondent's motion for a directed verdict on grounds that evidence failed to show the treatment given by licensee was done in chiropractic practice and to strike all testimony respecting the biometer, was denied. Exhibit 1, a photocopy of Dr. Dappolonia's license as a naturopathic physician was admitted into evidence without objection. J. L. Alexander, D. C., N.D. has been a licensed naturopath in Florida since 1950 and a licensed chiropractor since 1952. He did not renew his chiropractic license in 1975 and is now practicing only naturopathy. He operated a diagnostic machine similar to the one used by Dr. Dappolonia in Kentucky before he came to Florida in 1950. He knows the instrument as a radioclast or hemoclast and used a radiaclast in giving physiotherapy in Kentucky. Dr. Alexander described the radioclast as an electrical instrument used to measure vitality by picking up vibrations from various organs. He has used placebos but only to test the truth of a patient's symptoms. Dr. Alexander is aware of no school that teaches the use of the radioclast. Mrs. Dappolania presented receipts of payments made by Mrs. Carter as Composite Exhibit 3. On the top thereof appears (less address) NA PIER CLINIC CHIROPRACTIC AND MEDICAL NATUROPATHY A photograph of the front of Dr. Dappolonia' s office was admitted into evidence as Exhibit 2. Thereon, following the name M. Dappolonia, appears D.C., N.D. Dr. Dappolonia is licensed in Florida as a chiropractic and naturopath. He considered his prescription of pills for Suzanne Carter to be authorized under his license as a naturopath and his use of the diagnostic machine to be authorized under the same discipline. He treats no patients solely as a chiropractor and considers the form completed by his patients on their first visit, which nowhere thereon refers to specific treatment, to authorize him to treat these patients either as a naturopathic physician or as a chiropractor as he sees fit. The only time he advises patients he is operating under his naturopathic license is when be writes a prescription. He considers it difficult to draw the line between chiropractic and naturopathic practices except when drugs are dispensed which is always as a naturopath. He described the pills given to Suzanne as Celoid Salts. One contained sodium sulfate in a vehicle of milk sugar. Others he prescribed for Suzanne contained different salts in a malt sugar vehicle. For the insecticide poisoning the pill was an I-Celoid which contained a mixture of three individual cell salts containing magnesium, sulfur and iron. These pills were not given as placebos, but to reduce the systemic virus and insecticide poisoning diagnosed by use of the biometer. He stressed to Suzanne the necessity for her to believe in the treatment he prescribed in order for it to work. Dr. Dappolonia identified the instrument he used to diagnose Suzanne's illness as a biometer. He first became interested in "radionics" while a student at the National College in Chicago from which he received degrees in chiropractic and naturopathic. He took post-graduate work at a private school conducted by a Dr. Spitler, N.D. at Eton, Pennsylvania. The institution was a combination of clinic and school with only one instructor. According to Dr. Dappolonia it is absolutely necessary to have a background in electronics in order to understand the operation of the biometer. The biometer measures the body's resistance, but Dr. Dappolonia was usable to explain whether the resistance was to electrical current or to frequency or how such resistance was electronically measured. According to him all organs and glands give off fixed frequencies. As he explained the theory of the biometer it appears that every heart has a vibrating frequency that is the same regardless of the variations in age, condition, etc. of the patient. When an organ or gland is being tested the machine is set for the frequency applicable to that gland or organ and by finger touch on the black 4" x 4" x 1/3" sensor placed on the body the dial is adjusted so the vibrations are danced out. Any movement of the dials from the standard setting that are necessary to damp out the vibrations represent abnormalities in the organ or gland being tested. In this manner he diagnosed Suzanne Carter initially having 25 million units of infection and subsequently he diagnosed insecticide poisoning. When asked to draw a schematic diagram showing how the machine converted electrical energy into whatever impulses were transmitted through the 4" x 4" sensor Dr. Dappolonia drew what appeared to be the location of the knobs on the face of the instrument. This drawing is attached to the record as an unmarked exhibit. Its admission was objected to by Dr. Dappolonia and it was never accepted into evidence although no ruling was made on the objection at the hearing. This exhibit is now admitted as evidence of Dr. Dappolonia's understanding of electronics.
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.
The Issue Whether the Respondent committed the violation alleged in the Administrative Complaint issued October 2, 2006, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: The Department is the state agency responsible for investigating and prosecuting complaints against persons holding licenses in the health professions and occupations, including chiropractic physicians. See § 456.073, Fla. Stat. The Board of Chiropractic Medicine ("Board") is the entity responsible for imposing penalties against chiropractic physicians for violations of Section 460.413(1), Florida Statutes. See § 460.413(2), Fla. Stat. At the times material to this proceeding, Dr. Falowski was a chiropractic physician licensed to practice chiropractic medicine in Florida, having been issued license number CH 5108. Dr. Falowski was first certified in Florida to practice chiropractic medicine in 1986. Dr. Falowski also is certified to administer propriety drugs. At the times material to this proceeding, Dr. Falowski did business as Rainbow Rehabilitation, and his address of record was 4201 North State Road 7, Lauderdale Lakes, Florida 33319. On or about August 25, 2997, Dr. Falowski submitted an application for acupuncture certification to the Department. He paid a fee and was certified to take the acupuncture certification examination. His application reflects that he completed 105 hours of acupuncture training at the University of Miami. Dr. Falowski took the acupuncture certification examination in November 1997, but he did not pass the examination. On or about April 15, 1998, Dr. Falowski submitted a second application for acupuncture certification to the Department. He paid a fee and was again certified to take the acupuncture certification examination. His application reflects that he completed acupuncture training at the University of Miami. Dr. Falowski took the acupuncture certification examination in May 1998 and attained a passing score. On or about July 7, 1998, the Department mailed an Examination Grade Report to Dr. Falowski, advising him that he had passed the chiropractic certification examination for acupuncture. A Request for Registration Form for the Board of Chiropractic Medicine was included with the Examination Grade Report, and the instructions stated that the form and a check or money order must be returned to the Department within 45 days. The form listed a $100.00 fee for the Chiropractic Acupuncture Certification. There is nothing in the records of the Department indicating that it received the Request for Registration Form or check in the amount of $100.00 from Dr. Falowski, nor do the records reflect that Dr. Falowski has been issued an acupuncture certification.4 On or about December 28, 2005, writing was observed on the window of the Rainbow Rehabilitation office which stated: WE DO PHYSICALS & BLOOD WORK LICENSED ACUPUNCTURE EKG No acupuncture license number was listed on the window. Dr. Falowski intended to perform acupuncture treatments for any member of the public who requested these treatments at Rainbow Rehabilitation.5
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Chiropractic Medicine enter a final order Finding that Francis J. Falowski, D.C., offered to practice acupuncture when he was not certified to do so, in violation of Section 460.413(1)(t); Imposing an administrative fine against Dr. Falowski in the amount of $5,000.00; and Placing Dr. Falowski on probation for a period of two years, under such terms and conditions as the Board deems appropriate. DONE AND ENTERED this 20th day of March, 2008, in Tallahassee, Leon County, Florida. PATRICIA M. HART 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 20th day of March, 2008.
