The Issue The issues in this case are promoted through an administrative complaint brought by the State of Florida, Department of Health and Rehabilitative Services (Petitioner) against David J. Samara, M.D. (Respondent) in which the agency seeks to impose a $250 fine under the authority of Section 468.3101, Florida Statutes. In particular, the Petitioner requests that the Respondent be fined based upon his allowing Beth Walton to perform radiographic procedures at a time when that individual did not hold a radiologic technologist certificate. This conduct on the part of the Respondent is said to be a violation of Section 468.3101(1)(i), Florida Statutes, and Rule 10D-74.58(1)(e), Florida Administrative Code.
Findings Of Fact Chapter 468, Florida Statutes, Part IV, empowers Petitioner to regulate persons seeking or holding certificates to use radiation on human beings as radiologic technologists. This regulation excludes licensed practitioners. One of the categories of licensed practitioners would be a practitioner licensed to practice medicine in the state of Florida. Respondent is licensed to practice medicine in the state of Florida. He practices urology and general medicine. The administrative complaint which underlies this action was sent by certified mail on May 29, 1986, directed to the Respondent. It calls for the imposition of an administrative fine in the amount of $250 against Dunn Avenue Medical Center. See Petitioner's Exhibit 4 admitted into evidence, a copy of the administrative complaint. Dunn Avenue Medical Center is not a legal entity. This description characterizes the medical offices located at 1124 Dunn Avenue, Jacksonville, Florida. It does not describe a corporation or partnership, nor is it a fictitious name duly registered. From this information and the fact that the opportunity to request a hearing says "he" and not "it," it is presumed that the complaint concerns Respondent. He has acted in accordance with that impression by timely requesting a formal hearing. Respondent practices medicine at the Dunn Avenue location on an average of two days a week. Other physicians work at that location during the work week. Those individuals are not employees of the Respondent. They are independent contractors who pay for the use of the facility at Dunn Avenue and to use employees who work at the Dunn Avenue location. The real property at the Dunn Avenue office is rented by David J. Samara, M.D., P.A., a corporation in which the Respondent is a principal. This lease arrangement with the property owner of the Dunn Avenue location was signed by Respondent and another physician, Samir Najjar. Dr. Najjar is an employee of the Respondent. The other physicians who have been referred to in the previous paragraph as independent contractors are persons other than Dr. Najjar. Those individuals would include Doctors Wernow, Fuller and Tho Nguyen. One of the employees hired by Respondent and paid by the David J. Samara, M.D., P.A. was one Laura Beth Walton. She was employed as a medical assistant. This employment occurred in the early part of 1986. When she was hired, the understanding between the Respondent and Ms. Walton was to the effect that on March 20, 1986, she was expected to stand examination to obtain a certificate as radiologic technologist. She took the job a couple of weeks before this examination was to be given. At the time that she was hired, Respondent explained that she could not do any x-ray procedures until she had obtained a license. She was told that Respondent would attempt to obtain a temporary license for her benefit; however, that license was never obtained. During the time frame countenanced by the administrative complaint, Respondent performed all x-ray procedures related to his patients that would have transpired at the Dunn Avenue location. Nonetheless, he allowed Ms. Walton to escort the patients into the x-ray room and assist them in changing their clothing in anticipation of those procedures. He also explained to Ms. Walton how the x-ray procedures were conducted and taught her about the positioning of patients who were being examined through the x-ray procedures. Respondent allowed Ms. Walton to position patients while in his presence and with his ability to make changes in their positioning if he felt that Ms. Walton's positioning was incorrect. Respondent positioned the x-ray tube and performed the study, to include the engagement of the x-ray device. Ms. Walton was allowed to process the x-ray films. Gary L. Tomaszewski, Public Health Physicist Manager involved in the Petitioner's Radiologic Technology program, testified that the positioning of a patient is a part of the process of radiologic technology. Mr. Tomaszewski is qualified to give this opinion, and his opinion concerning the positioning of patients is accepted. Ms. Walton, during her employment at the Dunn Avenue location, conducted x-ray procedures for Drs. Wernow and Fuller without the benefit of their supervision. Respondent had not condoned this conduct on the part of Ms. Walton. Again, these procedures done at the behest of Drs. Wernow and Fuller were procedures for independent contractors who were utilizing the Dunn Avenue medical facilities. Ms. Walton, during her employment at the Dunn Avenue location, was never the holder of a certificate as radiologic technologist issued pursuant to Chapter 468, Florida Statutes. It is suggested by the witness Walton that one x-ray procedure was done for the benefit of Respondent's patient Virginia Reinhart without the Respondent's being present and supervising Walton and upon his instigation. Respondent denies this set of events, and his denial is found to be more compelling than the testimony offered by Ms. Walton. Neither the Respondent nor the arrangement for independent physicians to use employees paid by David J. Samara, M.D., P.A. and equipment in the office contemplated an arrangement in which an unqualified person, such as Ms. Walton, could perform x-ray procedures. That is to say that neither the Respondent in his individual capacity as a physician nor as a principal within the Samara P.A. contemplated this extra-legal activity by Ms. Walton. Equipment at Dunn Avenue, to include the x-ray machine, was owned by the David J. Samara, M.D., P.A. The initial awareness which the Petitioner had of the activities of Ms. Walton related to patient x-rays occurred based upon an inspection of the Dunn Avenue medical office performed on April 8, 1986. At that time, the Petitioner was under the impression that the name of the facility was Dunn Avenue Medical Center. That impression continued at the point of granting an opportunity for the problem to be redressed on April 22, 1986, when correspondence addressed to Dunn Avenue Medical Center purported to allow the "center" to explain why administrative action should not be taken against it for the use of Ms. Walton as an uncertified operator performing radiographic procedures. Response to that overture was delayed based upon the lack of knowledge of that correspondence on the part of Respondent. Subsequently, the Respondent did offer explanation by correspondence of May 16, 1986. Petitioner's Exhibits 1 through 3, respectively, are items pertaining to the inspection, notice to show cause and response to that notice. These items were received into evidence. The case was not resolved by the Respondent's explanation and there ensued the administrative complaint and request for hearing.
Findings Of Fact The Respondent, Wayne A. Bryan, is a chiropractic physician holding license number 0001861 issued by the Board of Chiropractic Examiners. At all times pertinent to the allegations contained in the Administrative Complaint, the Respondent engaged in the practice of chiropractic at the Bryan Chiropractic Clinic, 155 Ridgeway Drive, Sebring, Florida. On April 24, 1981, Jeanne Speight went to the Respondent's office for treatment of low back pain, which she attributed to work in her garden. Upon her arrival at the Respondent's office, Mrs. Speight was advised by an unknown female office employee that she would have to be "X-rayed before she was seen by the Respondent. A total of ten x-rays were taken of Mrs. Speight by an unknown employee before she was seen by the Respondent. After a physical examination, the Respondent told Mrs. Speight to return the next day with her husband because she had a serious, life-threatening problem. On the following day, Mrs. Speight returned to the Respondent's office with her husband. The Respondent spoke with the Speights and advised them that Mrs. Speight required an intensive treatment program consisting of four treatments per week over a three-month period with complete x-ray work-up each month during the treatment. When Mr. Speight questioned the necessity of so many x-rays and suggested they obtain a second opinion, the Respondent became angry and predicted that Mrs. Speight would lose 99 percent of the use of her legs and be paralyzed if she did not take his treatment. After her visits with the Respondent, Mrs. Speight sought treatment from another chiropractic physician, Dr. O. A. Speigel. Dr. Speigel requested Mrs. Speight's x-rays from the Respondent; however, the Respondent did not provide the x-rays, but furnished Dr. Speigel with a full report of the Respondent's findings, which Dr. Speigel described as excellent. Mrs. Speight's records and x-rays were later examined by Dr. Richard Carr, a chiropractic physician. According to Drs. Speigel and Carr, Respondent's diagnosis concerning Mrs. Speight's condition was consistent with the x-rays and reports. Further, did Respondent's prognosis as stated to the Speights that Mrs. Speight would lose 99 percent of the use of her legs was inconsistent with his diagnosis. On January 6, 1981, J. C. Hickman sought chiropractic treatment from the Respondent for a muscle spasm in his leg. Upon Hickman's arrival at the Respondent's office, prior to being seen by him but after a medical history was taken, Hickman had a series of spinal x- rays taken by Barbara Bryan, the wife of the Respondent. Mrs. Bryan was not licensed as a radiologic technologist in the State of Florida until February 12, 1982. During Hickman's first visit, an unknown female employee of Respondent's demanded and obtained a sample of Hickman's hair without explaining the purpose for obtaining this sample. Hickman was examined by the Respondent, who advised him that he had serious problems and proposed a series of chiropractic treatments. The Respondent told Hickman that he did not use his hands directly on a patient in rendering treatment. According to Hickman, the Respondent had him lie on the examining table in a prone position, and while he was in this position he received a mechanized blow or thrust to his chest. This description by Hickman of his treatment is not rejected but given less weight than his testimony on other aspects of his treatment with which Hickman was more familiar than the nature of Respondent's manner and method of treatment. The Respondent advised Hickman to return the following day in order to receive the same treatment for his leg. At no time did the Respondent examine or touch Hickman's leg. On or about July 11, 1980, Don Payne sought chiropractic treatment from the Respondent. Prior to examination by the Respondent, his wife, Barbara Bryan, took a series of x-rays of Payne. As stated above, Mrs. Bryan was not licensed as a radiologic technologist in the State of Florida until February 12, 1982. Thereafter, without explaining the purpose of it, Mrs. Bryan demanded a sample of hair from Payne. The manner in which the sample of hair was demanded annoyed Payne, who, although he permitted her to take the sample, did not advise Mrs. Bryan that he wore a full hairpiece from which the sample was taken. The medical records of Mary Scofield were received into the record as Petitioner's Exhibit 4. The only other evidence presented concerning Ms. Scofield was the deposition of Dr. Richard Carr based upon his examination of her medical records. Dr. Carr could not conclude from the records that the Respondent's diagnosis and treatment of Ms. Scofield were improper. Based upon their medical records, Dr. Carr opined whether hair analysis was proper with regard to the Respondent's patients. Dr. Carr based his opinion of the appropriateness of using this technique upon whether heavy metal poisoning was indicated in these patients. Because the test is recognized but controversial with regard to testing for vitamin deficiency, Dr. Carr's opinion is appropriately qualified. Mrs. Speight did not testify to any hair analysis performed. Hickman and Payne stated, and it is found that Respondent performed hair analysis.
Recommendation Having found the Respondent, Wayne A. Bryan, guilty of the allegations contained in Count Three, Count Six, Count Seven, and Count Ten of the Administrative Complaint, it is recommended that the Board of Chiropractic Examiners revoke the license of Respondent. DONE and RECOMMENDED this day of December, 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 14th day of December, 1983. COPIES FURNISHED: Diane F. Kiesling, Esquire Department of Professional Regulation 130 North Nonroe Street Tallahassee, Florida 32301 Wayne A. Bryan 12837 Township Road, 168-RR3 Findlay, Ohio 45840 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 =================================================================
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
The Issue Whether Respondent violated Subsections 458.331(1)(d), 458.331(1)(n), and 458.331(1)(t), Florida Statutes, and, if so, what discipline should be imposed.
Findings Of Fact Hammesfahr is a licensed physician in the State of Florida, having been issued Florida License ME 52212 on February 8, 1988. He is board-certified in neurology and pain management. Hammesfahr's office is located in Clearwater, Florida, where he maintains a practice treating patients who have had strokes. A stroke is a blockage of an artery in the brain that causes damage to the brain. As a result of the stroke certain cells within the brain will die, and the victim will develop a multitude of deficits, including paralysis, loss of vision, sensory loss, and memory problems. Between 1998 and 2000, Hammesfahr advertised his treatment for stroke patients and included the following statements in some of his advertisements: Using advanced technology, Dr. Hammesfahr has developed a sophisticated method to help restore blood flow to the damaged areas of the brain after a stroke. With increased blood flow to these areas, the brain can heal. Dr. Hammesfahr is the first physician to treat and successfully reverse the effects of stroke using vasodilators. These advertisements have appeared in Florida and in airline magazines, which travel throughout the country. In some of his advertisements, Hammesfahr indicated that based on an evaluation of the first 67 patients who went through the therapy 82 percent had major improvement, 11.9 percent had minor improvement, and 6 percent had no improvement. He further indicated that the study showing these results was peer-reviewed. Generally, Hammesfahr's treatment protocol is based on the concept of dilating blood vessels in the brain to optimize neurological function and neurological recovery. He uses vasodilator medications to dilate blood vessels in the brain and to increase blood flow into the brain. Various methods are used to monitor the therapy and improvement, including ultrasound, physical examinations, neuropsychological and physical therapy testing, EEG, transcranial Doppler, and blood pressure monitoring. Medications used to dilate the blood vessels include ACE inhibitors, calcium channel blockers, nitrates, alpha and beta blockers, and sympatholytics. After a stroke has occurred, brain cells in the center of the stroke are destroyed and cannot be revived. The area next to the stroke center is called the penumbra and consists of brain cells that are damaged and might recover. Hammesfahr does not claim that his treatment protocol can restore the brain cells that have been destroyed. He does claim that by using his protocol there may be some recovery in the damaged areas, where the blood vessels have restricted and narrowed. The medications dilate the vessels and increase the blood flow to the damaged areas. The recovery of a stroke patient consists of three phases: acute, subacute, and chronic. The acute phase occurs from the onset of the stroke to the next few days or weeks thereafter. The subacute phase starts at the end of the acute phase and lasts for approximately six weeks to three months. However, in certain cases it might last as long as 18 months. The chronic phase is the last phase, which commences at the end of the subacute phase and lasts for an indefinite period. Hammesfahr usually treats stroke patients who are in the chronic phase, but has also treated patients in the other phases of stroke recovery. When a patient contacts Hammesfahr concerning his stroke treatment, the patient will be sent a new patient package, which describes the phases of treatment, contains articles written by Hammesfahr concerning his treatment, and includes a fee schedule. Hammesfahr has different treatment plans from which the patient may choose to participate. The costs for the treatment vary according to the plan; the longer the patient is seen in Clearwater by Hammesfahr, the more costly the treatment. The average patient seen by Hammesfahr opts for the three-week plan. If a patient decides that he wants to be treated by Hammesfahr, the patient is required to see his primary care physician, provide the physician with the articles contained in the new patient package, and obtain his medical records from the physician. The primary care physician is to perform certain tests on the patient and give a medical clearance for the patient to travel to Clearwater, Florida, for treatment by Hammesfahr. The patient is also sent a package of materials, which includes a medical history form to be filled out by the patient and brought to Hammesfahr when the patient comes to Clearwater for treatment. When the patient initially presents for treatment at Clearwater, the patient is given an explanation of the treatment by Hammesfahr and his staff. Patients are advised that there are no guarantees that the treatment will be successful. An intake is performed to make sure that the needed forms are properly completed, including a history of the patient to determine that the patient's primary care physician has given the patient a clearance to come to Hammesfahr for treatment, and to review the medical records of the patient. A physical examination is performed on the patient. The patient is given a schedule for the time that the patient will be in treatment in Clearwater, and Hammesfahr's staff reviews the schedule with the patient. Tests are performed on the patient in Hammesfahr's office such as the transcranial Doppler ultrasound to generally determine the blood velocity. The patient is sent to Diane Hartley, a physical therapist, for testing of gross motor function, and to Dr. Alexander Gimon for neuropsychological testing. The tests given by Ms. Hartley and Dr. Gimon are standardized tests, for which the patient normally pays additional fees. The initial tests by Ms. Hartley and Dr. Gimon are given to form a baseline for a comparison with later test results. Those patients who are three-week patients will also have examinations by Ms. Hartley and Dr. Gimon at the end of their treatment period. The test results are compared with the test results taken at the beginning of the treatment period. The patient receives an orientation session in which the patient is informed of the responsibilities that the patient has during the course of treatment. Such responsibilities include taking blood pressure measurements at prescribed times of the day, charting the results of the blood pressure test, and seeing and providing the patient's primary care physician with the blood pressure readings. The patient must drink eight glasses of water a day, unless the patient has a heart disease, and must avoid certain types of foods that are vasoconstrictors. Once the patient completes the treatment at Hammesfahr's office, the primary care physician will take over the medical management of the patient's treatment. Hammesfahr's office will confer with the patient's primary care physician after the patient leaves Hammesfahr's office to discuss the monitoring of the patient and the altering of the patient's medication. One week after returning from treatment in Clearwater with Hammesfahr, the patient must see his primary care physician. In October 1999, a friend of M.T. mailed M.T. one of Hammesfahr's advertisements. As result of receiving the advertisement, M.T. contacted Hammesfahr's clinic and sought treatment from him for a stroke which she suffered in May 1999. Hammesfahr sent M.T. an information package and a videotape. The package contained articles written by Hammesfahr, a description of the different programs available, and a price list for the programs. M.T. decided that she would try a three-day program for $3,000. There was a dispute as to exactly which program M.T. received when she went to Clearwater. The only two programs which Hammesfahr listed as costing $3,000 were the Executive Stroke Prevention Program and the One-Week Evaluation and Treatment Program. The Executive Stroke Prevention Program was described as follows: This is a three (3) day program in which patients will undergo CAT scan and MRI at our facility, state of the art computerized EEG, and transcranial ultrasound to look at the blood vessels of the brain. They will undergo a comprehensive medical review and family review, as well as recommendations for lowering one's chances of a stroke or to treat if there has been a stroke in the past. This program is not covered by insurance. The One-Week Evaluation and Treatment Program was described as follows: This program is designed for those who want to start the stroke program and have the program advanced to a level which makes it significantly easier for the family physicians at home and neurologists to continue the program safely and rapidly. The first days [sic] involved in the initial evaluation, as well as any testing such as EEG and ultrasound testing, if necessary, and CT scans and MRIs as well as blood tests, followed by days two through five being involved in the initiation of medical treatment in that either treating the previous stroke or preventing future strokes. Recommendations are then made to the family physician or neurologists for caring through on this program. There was an additional three-day program, Initial Evaluation and Treatment, which listed for $2,000 and provided the following: This is a three (3) day consultation and evaluation with recommendations for treatment. This program is designed for patients who are interested in treatment of their stroke by their family physicians at home. A comprehensive evaluation will be made by our physicians as well as treatment recommendations. This evaluation will include review of CAT scans or MRIs and blood tests, and when appropriate, computerized EEG testing, neuropsychological testing, and ultrasound evaluations. The program is approximately three days. Prior to traveling to Hammesfahr's clinic, M.T. was directed by Hammesfahr to obtain medical tests from her primary care physician, which she did. The tests included a CT scan of the brain, a CMP, liver profile, CBC with different platelets, Westergren's sed rate, EEG, CVA, and EKG. She was also required to take and write down her blood pressure two times a day for a week before going to Hammesfahr's clinic. M.T. also filled out a medical history form and a system review checklist prior to her visit to Hammesfahr. In a letter dated February 12, 2000, to M.T. on Hammesfahr's letterhead, his office staff described the treatment that M.T. would receive as follows: Your first visits with us will be quite long. So, plan accordingly. On your first day, you will have a consultation with the doctor. The second day you will have diagnostic testing in our office, and an appointment with Dr. Gimon for a neuro- psychological evaluation and Diane Hartley for a physical therapy evaluation. Both of these doctors will be calling you to set up these appointments. The neuro-psychological testing will help us to evaluate any memory changes. You will probably see Dr. Gimon again towards the end of your treatment. On Tuesdays and Thursdays there is an orientation session outlining what we will be doing here in the office and [sic] explaining our treatment program will be given out. Each new patient must attend one of these sessions. Every day thereafter, your visit will be at least two (2) hours long. As you know, our treatment consists of sessions in this office each day Monday through Friday for the duration of your therapy. Please note: No warranties or guarantees can be made regarding the time, the degree, or the duration of improvement with this therapy. On February 20, 2000, M.T. signed a Waiver for Use of Medications, which stated: I am, or my caregiver is, aware that I have had a neurological disease and have failed to respond to other types of medications used in the conservative management of my condition. . . . Options available to me at this time are those now used at the Florida Neurological Institute. I am aware that the medications used in this therapy are medications that have FDA approval. However, I am also aware that the FDA has not approved these medications in the doses and number of medications used here at the Institute. I am aware that Dr. Hammesfahr has published many articles on his therapy. I am aware of the fact that, during the past two years, the Institute has treated many patients with similar conditions and that most have had at least some improvement in the symptoms associated with their problem. I have, and my caregiver has, been counseled regarding this theory under which this therapy is being promulgated. Upon arrival at the Florida Neurological Institute, I and my caregiver, will see and listen to the videotapes available regarding this therapy. I have, or my caregiver has, read this waiver and understands its contents. I am, and my caregiver is, aware that there is no indicated use for this therapy now. I have had all questions I may have concerning the use of these medications answered, I agree to undergo the use of these medications as outlined in the material presented to me. As stated above, I am fully aware of the fact that this therapy probably will not be covered by my insurance, but I wish to continue with this therapy as outlined to me in my training and information sessions. I also understand that no physician, or any other person in this office, can make any guarantees of success from this therapy. (Emphasis in the original) On February 28, 2000, M.T., accompanied by her husband, presented to Hammesfahr's clinic in Clearwater, Florida, for treatment. On her first day at the clinic, she received an orientation. She was required to pay $3,000 for her treatment. A staff member at Hammesfahr's clinic took M.T.'s blood pressure and directed M.T. to take her own blood pressure readings thereafter. On the second day of treatment, February 29, 2000, M.T. was sent to Dr. Alexander Gimon, a neuropsychologist, for a 30-minute evaluation. A staff member of Hammesfahr's clinic gave M.T. a transcranial Doppler, a carotid artery ultrasound, and an electrocardiogram. A Physician's Office Visit History and Physical Examination Form was filled out with a date of "2-28-00" struck through at the top of the form and the date of "2-29-00" placed next to it. At the end of the form appeared a physician's statement signed by Hammesfahr and dated February 22, 2000, a week before M.T. presented for treatment, stating that he had "examined this patient, reviewed his/her history, and consulted with him/her and the caregiver regarding the treatment planned here at Florida Neurological Institute." An Objective (Physical Examination) form was filled out, again with the date of "2-28-00" struck through at the top of the form and the date "2-29-00" placed next to it. The form does not indicate who performed the physical examination. The form does indicate that M.T.'s blood pressure and pulse readings were taken. M.T. met with Hammesfahr, who observed her gait and told her that he would send her back home and would work with her physicians. He did not prescribe any medications at that time and did not give M.T. any medications during her treatment at his clinic. On March 1, 2000, M.T. was supposed to meet with the physical therapist, Diane Hartley, for evaluation at 8:00 a.m. When she arrived at Ms. Hartley's facility, no one was there to let M.T. in the building. When M.T. went into the facility, she did not like the looks of the building, describing it as "shoddy looking." She decided that she did not want to stay for an evaluation and left. The fee Hammesfahr charged M.T. included the fees for Dr. Gimon and Ms. Hartley. On March 1, 2000, M.T. and her husband returned home with the understanding that Hammesfahr would be contacting her doctors in Alabama to arrange for the administering of the medications. M.T. was told to make an appointment with her primary care physician for the week after she returned from Clearwater. Hammesfahr first communicated with M.T.'s physicians by letter, dated April 5, 2000, asking them to administer the vasodilators and magnesium sulfate I.V.'s. M.T.'s physicians in Alabama refused to administer the medications. M.T. did not take the vasodilators, which Hammesfahr wanted her physicians to administer; nevertheless, M.T. improved. Based on the rate schedule presented to M.T. for Hammesfahr's various treatment programs, she should have received either the Executive Stroke Prevention Program or the One-Week Evaluation and Treatment Program. Hammesfahr was adamant that M.T. did not sign up for the Executive Stroke Prevention Program, and the evidence established that she did not receive this program. M.T. was given an itinerary that indicated that she would be treated by Hammesfahr for a week; however the evidence established that she did not receive the treatment that was supposed to be given in the One-Week Evaluation and Treatment Program, which promised that the initiation of medical treatment would be done on days two through five. Hammesfahr did not administer any medications or prescribe any medications for M.T. during her stay in Clearwater. The evidence does show that M.T. received the three-day Initial Evaluation and Treatment Program, for which she should have been charged only $2,000. Hammesfahr presented the expert testimony of Dr. Jacob Green, who is a board-certified neurologist, practicing in Jacksonville, Florida. He has been practicing for over 35 years. Dr. Green has written papers on the use of transcranial Doppler, and he is experienced in the treatment of acute and chronic stroke patients. Dr. Green is familiar with the protocol and procedure utilized by Hammesfahr in treating stroke patients. He has read articles written by Hammesfahr, reviewed patients' records, and spent a day in Hammesfahr's office observing Hammesfahr's practice and treatment protocol which is at issue in this case. While he was at Hammesfahr's clinic, Dr. Green observed Hammesfahr treat patients, reviewed medical records of patients when they first came to Hammesfahr for treatment, and compared the findings in those records to his observations of the patients' abilities. Dr. Green discussed the treatment and protocol with Hammesfahr. Based on his deposition testimony, Dr. Green had a good understanding of the treatment and protocol used by Hammesfahr for stroke patients. Dr. Green described the standard of care for a stroke patient as "to do good by the patient, do no harm." According to Dr. Green, Hammesfahr's care and treatment and protocol complied with the standard of care. Hammesfahr presented the expert testimony of Dr. William Scott Russell, Jr., a retired neurologist with 33 years of experience. In his practice, he had treated thousands of stroke patients. Dr. Russell retired in October 1998. Dr. Russell had first-hand knowledge of the protocol used by Hammesfahr when he treated Dr. Russell for an acute stroke. Prior to Dr. Russell's being treated by Hammesfahr, Dr. Russell had reviewed a paper written by Hammesfahr concerning Hammesfahr's treatment protocol for stroke victims using vasodilators. Dr. Russell considered the treatment protocol espoused by Hammesfahr to not be below the standard of care as of 1998. In 1996, Dr. Russell experienced a stroke. When he awoke one morning, he was confused. He went to work and had difficulty with his abilities to speak and write. Dr. Russell realized that he was experiencing a stroke and had a technician in his office run an EEG. He had peer-reviewed some of Hammesfahr's papers prior to his stroke and was impressed with Hammesfahr's work. So, he contacted Hammesfahr and presented at Hammesfahr's clinic for treatment the day he experienced the stroke. Hammesfahr performed a transcranial Doppler on Dr. Russell and administered nitroglycerine to dilate Dr. Russell's blood vessels. Ten minutes after the nitroglycerine was administered, Dr. Russell's symptoms disappeared. Within a reasonable degree of medical probability, the cause of his recovery was the use of the nitroglycerine. Nitrates are used for acute stroke patients when the patient has an extremely high blood pressure. The nitrates lower the blood pressure and are given intravenously so that the medication can be discontinued immediately if the blood pressure should fall too low. There was no evidence presented to determine whether at the time that Hammesfahr administered nitroglycerine to Dr. Russell that Dr. Russell's blood pressure was high. At the time of the final hearing, Dr. Russell felt that he had total recovery from the stroke deficits. He has reduced his intake of medications prescribed by Hammesfahr and has not had a return of the deficits. The Department presented the testimony of four expert witnesses concerning the standard of care for treatment of stroke victims: Dr. Harold Charles Friend, Dr. Steven Novella, Dr. David F. Scales, and Dr. Thomas Hoffman. Dr. Hoffman has been practicing neurology in Melbourne, Florida, since 1982. Approximately five to ten percent of his patients have had a stroke or a cerebral vascular disease. He has read some of Hammesfahr's advertisements and viewed Hammesfahr's article on Hammesfahr's Internet web site. Dr. Hoffman understands Hammesfahr's protocol to be the use of medications to increase the cerebral blood flow and the use of the transcranial Doppler to direct the medication treatment by measuring the cerebral blood flow. Dr. Hoffman does not agree that the use of vasodilators increases the blood flow to the brain. There is a loss of cerebral autoregulation when a stroke occurs. According to Dr. Hoffman, the use of vasodilators can decrease the blood flow to the brain and worsen neurological functioning in acute stroke patients. It is the opinion of Dr. Hoffman that Hammesfahr's treatment of stroke patients falls below the standard of care for acute, subacute, and chronic stroke patients. Dr. Steven Novella is a neurologist and an assistant professor at Yale University. He received his medical license in Connecticut in 1993 and obtained his board certification in neurology in 1998. He treats stroke patients and is familiar with the appropriate treatment for stroke patients. Dr. Novella understands that the treatment for stroke patients which Hammesfahr advocates is the administration of vasodilators to expand blood vessels which have an insufficient blood supply due to constriction. He disagrees with Hammesfahr's theory, espousing that the blood vessels in the area of the brain that is not receiving enough blood flow will dilate as far as they can go and that the blood vessels will not respond to the vasodilators because the blood vessels are already maximally dilated. Dr. Novella is of the opinion that vasodilators may be used for stroke patients to reduce the risk of another stroke when the patient is hypertensive, but that the vasodilators should not be used as a method of reversing deficits caused by stroke. Dr. Harold Charles Friend is a board-certified neurologist, who has been practicing neurology for 26 years. He practices in Boca Raton, Florida. Approximately five to eight percent of his practice is dedicated to treating stroke patients. He is currently treating in excess of 500 stroke patients. Dr. Friend has reviewed the charts of two patients of Hammesfahr, an article written by Hammesfahr, some of Hammesfahr's advertisements, some newspaper articles, and an article authored by Hammesfahr, which appeared on an Internet site. Dr. Friend also saw a patient in his office that had previously been treated by Hammesfahr. Based on the information from these sources, Dr. Friend incorrectly understood that Hammesfahr's methodology was to basically lower the blood pressure of his patients in an attempt to restore dead cells. He also concluded that the patients seen by Hammesfahr were also receiving physical therapy at the time of treatment. Dr. Friend opined that Hammesfahr's treatment of chronic stroke victims did not comport with the standard of care recognized in the medical community. He further concluded that given the medications that Hammesfahr administers to his patients, that one would expect some adverse effects or no effect on the patients. The only mention in the record of a patient's being harmed by Hammesfahr's treatment was by Dr. Friend. Dr. Friend reviewed a medical chart of a patient who had worsened after treatment by Hammesfahr and had to go to another physician, Dr. Nassar Elmansoury, to correct the problem. The patient had been prescribed Accupril, ten milligrams four times a day, and nitroglycerine cream. Both medications are vasodilators. When the patient presented to Dr. Elmansoury, the patient was feeling worse and experiencing chest pain, dizziness, and disequilibrium. Dr. Elmansoury eliminated the nitroglycerine cream and reduced the amount of Accupril. Within two weeks, the patient was improved. Dr. David F. Scales is a board-certified neurologist, who has been practicing for 34 years. He currently practices in the Jacksonville, Florida, area at the Jacksonville Neurological Clinic. About 50 percent of his in-patient practice consists of stroke patients. Stroke patients comprise about 20 to 25 percent of the entire practice. Dr. Scales has reviewed the medical records of two of Hammesfahr's patients, articles written by Hammesfahr, literature provided by Hammesfahr to his patients, and Hammesfahr's Internet web site. Dr. Scales understands Hammesfahr's theory to be that vasodilators are administered to dilate the blood vessels in the brain so that more blood flows through the penumbra, reactivating neurons that were in a suspended state of activation. He does not agree with Hammesfahr's theory because the blood vessels in the penumbra would be dilated to the maximum and the medications would dilate blood vessels in other parts of the body, which would in turn take away or steal the blood flow from the blood vessels in the penumbra. After reviewing the medical records of two of Hammesfahr's patients, M.T. and M.S., Dr. Scales was of the opinion that the treatment provided by Hammesfahr did not meet the standard of care for the treatment of stroke patients. Having considered the testimony of the experts presented by the parties, it is determined that the standard of care for the treatment of stroke patients varies according to the stage, type, and severity of the stroke. In the acute stage, the patient is admitted to the hospital. A medical history is taken and a physical exam is given, followed by appropriate laboratory and imaging studies to determine the site and cause of the stroke. For patients seen within three hours of the onset of the stroke, certain intravenous medications may be given in an attempt to break up the blood clot. For patients seen beyond the three-hour point, the treatment is maintenance of their blood pressure, monitoring of their vital signs, and treating any complications that may occur such as pneumonia and urinary tract infections. Patients may be given blood thinners to improve the flow of the blood, and medication to increase the blood pressure in the event the blood pressure is too low. Patients with severe hypertension, generally a blood pressure over 220 systolic or 120 diastolic, are given medications to lower their blood pressure. Patients with asymptomatic hypertension are treated judiciously during their hospital stay with anti-hypertensive medications, and the blood pressure is gradually lowered. The standard of care for subacute stroke patients is a continuation of the treatment given in the acute phase. Patients will be started on rehabilitation therapy, which may include speech, occupational, and physical therapy. The standard of care for chronic stroke patients, whom the physician is seeing for the first time, would be to take a history to determine what happened, review the medical records and any imaging studies that may have been done, and review the treatment they have had. The physician should assess the patients' risk factors for stroke such as hypertension, hyperlipidemia, diabetes, and smoking and manage those factors aggressively. Treatment with antiplatelets such as aspirin or an anticoagulation medication might be indicated. An assessment of their neurological functional abilities should be done to determine whether aids, braces, further therapy, or home care could be beneficial. Based upon the evidence presented, the treatment advocated by Hammesfahr is not within the generally accepted standard of care. However, the evidence is not clear and convincing that the treatment used by Hammesfahr is harmful to his patients. There is literature in the medical community that vasodilators can be used in the treatment of stroke as a measure to prevent future strokes. There is evidence that in over 200 patients seen by Hammesfahr that a large percentage improved after being treated by Hammesfahr. Dr. Gimon tested a group of 168 stroke patients seen at Hammesfahr's clinic during the period of November 1999 to May 2000 and another group of 163 stroke patients seen during October 2000 through February 2001. The same battery of tests was administered to both groups. Dr. Gimon evaluated these patients on nine separate neurological evaluations that are standard instruments recognized in neuropsychology. The tests measured identified areas of brain function, including verbal, visual, visual motor, and conceptual thinking. Both groups of patients were tested prior to the treatment by Hammesfahr. The patients were tested again approximately 18 to 21 days after they began treatment at Hammesfahr's clinic. The test results showed that many patients showed improvements in the areas tested. The improvements noted were measured as to a statistical difference so that the findings could not be attributable to testing error. Some patients showed no improvement in all areas. The test results revealed that there was no neuropsychological deterioration of the patients tested. Diane Hartley tested two groups of Hammesfahr's patients, who were treated at his clinic during the period of January to December 2000. Her tests were designed to measure functional motor improvement from a gross motor standpoint. She performed tests on the patients prior to their beginning treatment with Hammesfahr and again approximately two and one half to three weeks after the patients had begun treatment. Of the 242 patients tested by Ms. Hartley, 221 patients demonstrated improvement in one or more of the areas tested and 21 patients showed no improvement. Of the patients tested, ten received physical therapy from Ms. Hartley while they were being treated by Hammesfahr. These ten patients demonstrated a significant amount of improvement, which Ms. Hartley could not attribute solely to the physical therapy they received. The evidence establishes that Hammesfahr informed his patients by the use of videos, orientation sessions, literature, and a web site on the Internet of the nature of the therapy and did not guarantee that the patients would improve as a result of the treatment. Patients were able to make an informed decision on whether to try Hammesfahr' treatment.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Hammesfahr did not violate Subsections 458.331(1)(d) and 458.331(1)(t), Florida Statutes; finding that Hammesfahr did violate Subsection 458.331(1)(n), Florida Statutes; placing Hammesfahr on probation for six months; and imposing a $2,000 administrative fine. DONE AND ENTERED this 20th day of November, 2002, in Tallahassee, Leon County, Florida. _____ SUSAN B. KIRKLAND 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 November, 2002.
Findings Of Fact At all material times, Respondent has been currently licensed as a physician in Florida, holding license ME 0033496. Patient 1 was a 32 year old female who was admitted to Lykes Memorial Hospital on March 24, 1988, due to upper and lower abdominal pain, vomiting, and early signs of dehydration. Respondent placed Patient 1 on intravenous fluids and administered medications to control the vomiting. Patient 1 underwent diagnostic studies, including an upper gastrointestinal series, and received medication for the abdominal pain. After five days of hospitalization and tests, the source of the pain had not yet been identified. However, the lower abdominal pain had ceased, and the upper abdominal pain had lessened considerably. In general, the patient had improved during the hospitalization. At this point, Respondent discharged Patient 1 from the hospital with a final diagnosis of acute gastroenteritis. Respondent directed Patient 1 to return to his office for a follow-up visit. Five or six days after discharge, Patient 1 called Respondent and told him that her symptoms, which she now linked with taking birth control pills, had disappeared. Respondent advised her not to resume taking the pills, but to return to her gynecologist. With respect to Patient 1, Respondent practiced medicine with that level of care, skill, and treatment that is recognized by a reasonably prudent similar physician as being unacceptable under similar circumstances. Patient 2 was a 37 year old male who was admitted to Lykes Memorial Hospital on May 9, 1988, after having been found by a relative in a state of semi-consciousness. The admitting diagnosis was a probable overdose of lithium and possibly Thorazine. Respondent treated the drug toxicity during Patient 2's three-day hospitalization. Respondent became increasingly lucid during his hospitalization, and Respondent successfully managed the event of drug toxicity. Respondent tried to elicit from Patient 2 a medical and psychiatric history, but Patient 2 would or could not cooperate. Respondent was unable to identify any relatives or friends of Patient 2, including the person who brought him to the hospital. Respondent could not even find out where Patient 2 obtained the lithium and Thorazine that he was taking. Respondent treated the altered mental status that Patient 2 presented. There was no need during the short period of hospitalization to obtain a psychiatric consultation. Resumption of psychotropic medication so soon after the drug intoxication would have been imprudent. Consistent with the policy of Lykes Memorial Hospital, which has no psychiatrists on staff, Respondent referred Patient 2 to the Hernando County Mental Health Center. He directed Patient 2 not to take lithium or Thorazine until instructed to do so by a psychiatrist or other physician at the mental health center. Respondent and the hospital ensured that Patient 2 got to the mental health center following discharge. With respect to Patient 2, Respondent practiced medicine with that level of care, skill, and treatment that is recognized by a reasonably prudent similar physician as being unacceptable under similar circumstances. Patient 3 was a 49 year old male who was admitted to Lykes Memorial Hospital on or about February 5, 1988, with complaints of difficulty breathing. At the time, Patient 3 had been diagnosed with lung cancer that had metastasized to the spine and had undergone maximum radiation therapy. He was paralyzed from the waist down and in the last year of his life. He steadfastly refused all diagnosis or treatment involving radiation. By his own request, Patient 3's standing medical orders were "Do Not Resuscitate." He only wanted to be made comfortable. The acute illness resulting in Patient 3's admission was pulmonary congestion. There is some likelihood that the symptoms of infectious bronchitis with which he presented at time of admission were exacerbated by his chronic obstructive pulmonary disease. There is a possibility that some of Patient 3's discomfort was caused by mucous plugs in the lungs, whose capacity had already been diminished by the other diseases. However, mucous plugs were not affecting Patient 3 at the time of discharge. Respondent discussed with Patient 3 the possibility of cleaning out his lungs with a bronchoscope, but Patient 3 refused. Respondent treated Patient 3's discomfort with oxygen, diuretics, and increased steroids. Patient 3 had been receiving steroids due to a spinal disorder resulting from the cancer. Patient 3 was already receiving bronchodilators at the time of his admission. There is also a possibility that Patient 3 suffered from superior vena cava syndrome in which one or more tumors would block veins of the thorax. However, diagnosis of the condition would have been invasive, and Patient 3 refused such interventions. Treatment of such a condition would likely have required radiation, and Patient 3 would not tolerate additional radiation treatment. Respondent discussed with Patient 3 the possibility of superior vena cava syndrome and the possible treatment, but Patient 3 declined this intervention. Patient 3 received no EKG while in the hospital. The emergency medical services team transporting Patient 3 to the hospital performed a rhythm strip, which provides information about limited cardiac functions. Although Patient 3's potassium levels were slightly below normal at discharge, they had improved during hospitalization. With respect to Patient 3, Respondent practiced medicine with that level of care, skill, and treatment that is recognized by a reasonably prudent similar physician as being unacceptable under similar circumstances. Respondent's medical records represent the bare minimum required by law to justify the course of treatment. Matters discussed with Patient 3 were not always recorded. Patient 3's decisions concerning diagnosis and treatment were likewise not always recorded. But, on balance, the medical records adequately documented the course of treatment of Patient 3 while under Respondent's care at the hospital. Patient 4 was a 68 year old male who was admitted to Lykes Memorial Hospital on or about February 14, 1988, with complaints of a persistent cough and some gastric upset. He was suffering from exacerbation of chronic obstructive pulmonary disease. Respondent appropriately treated Patient 4's conditions. Patient 4 experienced problems with certain medications, which interfered with his progress, but he was drinking and eating without difficulty prior to his discharge. X-rays taken at admission and discharge revealed no significant change in Patient 4's condition during his eight-day hospitalization. At discharge, Respondent ordered Patient 4 to return for an office visit in two weeks. Patient 4's condition continued to improve following discharge. With respect to Patient 4, Respondent practiced medicine with that level of care, skill, and treatment that is recognized by a reasonably prudent similar physician as being unacceptable under similar circumstances.
Recommendation Based on the foregoing, it is hereby RECOMMENDED that the Department of Business and Professional Regulation enter a final order dismissing the administrative complaint. ENTERED on October 11, 1993, in Tallahassee, Florida. ROBERT E. MEALE 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 on October 11, 1993. APPENDIX Treatment Accorded Proposed Findings of Petitioner 1-5: adopted or adopted in substance. 6: rejected as unsupported by the appropriate weight of the evidence. 7-12: adopted or adopted in substance. 13: rejected as unsupported by the appropriate weight of the evidence. The pain or discomfort had lessened considerably. 14: adopted. 15: rejected as unsupported by the appropriate weight of the evidence. 16-17: rejected as irrelevant and unnecessary. 18: rejected as unsupported by the appropriate weight of the evidence. and 21-23: adopted or adopted in substance. and 24: rejected as unsupported by the appropriate weight of the evidence. 25: adopted except that Respondent and the hospital ensured that the patient was referred to a mental health treatment center as soon as his condition was sufficiently stabilized to allow discharge from the hospital. 26: rejected as unsupported by the appropriate weight of the evidence. 27: adopted or adopted in substance. 28: rejected as unsupported by the appropriate weight of the evidence. The record does not suggest how a psychiatrist would obtain a history from an unwilling patient. 29: adopted with respect to the period of the hospitalization through the point at which the patient could recommence active psychiatric treatment. 30: rejected as unsupported by the appropriate weight of the evidence. Respondent duly referred the patient to an appropriate facility for the treatment of the patient's underlying mental health problems. 31: rejected as recitation of evidence and subordinate. 32: rejected as legal argument and unsupported by the appropriate weight of the evidence. 33-36: adopted or adopted in substance. 37-38: rejected as unsupported by the appropriate weight of the evidence. 39: rejected as subordinate. 40: rejected as unsupported by the appropriate weight of the evidence. 41-43 (through third sentence): adopted or adopted in substance. 43 (fourth sentence): rejected as unsupported by the appropriate weight of the evidence with respect to this patient. 44-48 (first sentence): adopted or adopted in substance. 48 (except first sentence)-50: rejected as irrelevant and subordinate. 51-52 and 54: adopted or adopted in substance. 53: rejected as unsupported by the appropriate weight of the evidence. 55-56: adopted or adopted in substance. 57-59: rejected as unsupported by the appropriate weight of the evidence. Treatment Accorded Proposed Findings of Respondent 1-6: adopted or adopted in substance. 7: rejected as legal argument. 8: rejected as recitation of evidence. 9: rejected as legal argument and recitation of evidence. 10: adopted or adopted in substance. 11: rejected as recitation of evidence. 12: rejected as recitation of evidence and subordinate. 15: adopted or adopted in substance. 16 (first sentence): rejected as legal argument. 16 (second and third sentences): adopted or adopted in substance. (fourth sentence): rejected as recitation of evidence. (first sentence): rejected as legal argument. 17 (second sentence): adopted or adopted in substance. 17 (third sentence)-19 (first sentence): rejected as recitation of evidence. 19 (second sentence): adopted or adopted in substance. 20: rejected as recitation of evidence. 21: rejected as legal argument and recitation of evidence. 22: rejected as legal argument and recitation of evidence. 23: rejected as subordinate. 24: rejected as recitation of evidence. 27: adopted or adopted in substance. 28-31 (second sentence): rejected as legal argument and recitation of evidence. 31 (third sentence): adopted or adopted in substance. 32-34: rejected as legal argument and recitation of evidence. 38: adopted or adopted in substance. 39-43: rejected as legal argument, recitation of evidence, and subordinate. COPIES FURNISHED: Dorothy Faircloth Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, FL 32399-0792 Jack McRay, General Counsel Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792 Barbara Whalin Makant, Staff Attorney Department of Business and Professional Regulation Northwood Center, Suite 60 1940 N. Monroe St. Tallahassee, FL 32399-0972 William B. Taylor, IV Macfarlane Ferguson P.O. Box 1531 Tampa, FL 33618
The Issue Should Respondent be disciplined for practicing beyond the scope of his license or by accepting and performing professional responsibilities which he knows or has reason to know that he is not competent to perform? See Section 460.413(1)(t), Florida Statutes, formerly Section 460.413(1)(u), Florida Statutes.
Findings Of Fact Petitioner is charged with regulating the practice of chiropractic pursuant to Sections 20.165, 20.42, Florida Statutes and Chapters 455 and 460, Florida Statutes. Respondent is a Florida licensed chiropratic physician. His license number is No. CH-0001538. He was issued that license on September 21, 1968. Respondent practices chiropratic at the McCall Chiropractic Clinic located at 811 Grace Avenue in Panama City, Florida. Respondent is not licensed as an osteopathic or allopathic physician as recognized by the Florida Board of Osteopathic Physicians or the Board of Medicine respectively. In 1992 Respondent sent Micheal Smith, D.C., a chiropractic physician practicing in Panama City, Florida, information described as an invitation for Dr. Smith to join Respondent in clinical research "designed to test the effectiveness of Scalar E.M. Technology upon AIDS-CANCER opportunistic organisms falling within the meaning of chapter 460.403(3)(a)(b)(c)(e), and Rule 21D-1702, Florida Statutes." The correspondence went on to describe some details about the research. In particular, Respondent stated that "preliminary field data suggest that Scalar E.M. TENS Technology is effective in 47 pathological conditions including AIDS-Cancer disease." The correspondence also set forth information concerning patients who wished to contribute to the research by making financial contributions to the "Allaganey Occupational Development Foundation, 22 Floor Pacific First Center, 1425th Avenue, Seattle, Washington 98101-2333". Respondent provided Dr. Smith a sheet on the McCall Chiropractic Clinic letterhead related to purported medical research at Stanford University in 1988 studying "the Biological Interactions with the Scalar Energy Cellular Mechanisms of Action" in response to weak ELF ectromagnetic (EM) radiation and the claimed results. That sheet describes how the McCall Chiropractic Clinic would be "conducting private research into the effectiveness of Scalar E.M. Technology upon the following conditions, for a two-year period of time." Arthritis Arm Pains Angina Pectoras Arethemia Asthma Allergies Bacterial Infection of the Lung Carple Tunnel Syndrome Cancer of the: Bone, Brain, Bladder, Bowell, Lungs, Liver, AIDS Colon Polyps Cholitis Candidia Albicans Deafness Diabetes Neuropathy Emphysemia Eckcemia Ear Infection Epstine Barr Infection Exothalmic Goider Feavers Fungus of the skin Fibrosis of the Lung Gout High Blood Pressure Herniated disc Herpes B infection Hemrroids Hardening of the arteries Herpes of the Genitals Hypertrophy of the Prostate Inflimation of the joints Nectniuria Kendidia Albicans Leg Pains Multipleschlerosis Musculardistrohy Neuropathy Nose bleads Premenstral Syndrome Paracititis of digestive track Phlebitis Sinus Infection Tumors of the Eye Varicose Veines Warts Leupus Erethematosis Parkinsons Disease Dr. Smith was also provided with a copy of an advertisement which stated: ATTENTION: Aids - Cancer Patients Dr. Curtis J. McCall, Jr. Chiropractor Research program utilizing scalar tens antineoplastic technology is available through the provisions of Chapter 460.403(3)(a)(b)(c)(e) Rule 21D-1702 Florida Statutes. Patients suffering with Aids - Cancer disease who would like to participate in the research program should call 769-1708 for an appointment or come by the office: 811 Grace Ave., P.C., Fla. 32401 In the 1993 yellow pages for the Panama City, Florida, telephone book, Respondent placed an advertisement to this effect: MCCALL CHIROPRACTIC CLINIC PEOPLE HAVE TRUSTED THE HANDS OF DR. McCALL SINCE 1968 -- TENS AIDS -- CANCER THERAPY -- 811 Grace Av Panama Cy 769-1708 In the July 8, 1993 advertising service in the "Thrifty Nickel" circulated in Panama City, Florida, Respondent placed the following advertisement: NOTICE: The McCall Chiropractic Clinic has on display a 1953 classified federal document that discloses successful treatment for cancer. Patient response indicates this technology is effective in the treatment of 47 conditions. This technology is available through the provisions or Chapter 460- 1403(3), (a), (b), (c), (e). Rule 210-1702 Florida Statutes. Phone 769-1708 for appointment, 811 Grace Avenue, Panama City, Florida 32401. F24 On July 19, 1993, Respondent, on stationary from McCall Chiropractic Clinic, wrote to TCRS, Inc., in Tallahassee, Florida, asking that company to place McCall Chiropractic Clinic on its list of AIDS/Cancer Therapeutic Center listings for national referrals. That correspondence gave a brief description of the service that Respondent intended to provide. It indicated that the therapy to be provided would cost the patient $18.00 per 20 minutes. Through Respondent's activities that have been described, Respondent directly held himself out to the public as having the ability to treat persons with AIDS. In furtherance of his intentions, Respondent developed a treatment protocol consisting of approximately 55 weeks of treatment to be monitored initially by Respondent at his chiropractic facility. That protocol required the patient to receive TENS therapy for two hours each day. The TENS device is designed to deliver transcutaneous electrical nerve stimulation. Its principal chiropractic use is for pain control. However, Respondent, in his intended care, contemplated that the device would stimulate "T-Cells" in combatting AIDS. In the protocol, Respondent also required monthly blood tests to monitor the patient's "T-Cell" counts. The protocol required the patient to be free from all other drugs, in particular, the AIDS treatment medication "AZT". Under the protocol, the patient was required to receive a weekly injection of a compound identified as "chondriana", in amounts determined by Respondent. Finally, the patient was to ingest a compound identified by Respondent as "life crystals". On or about February 4, 1994, Respondent began to care for the patient C.L. That care ended on September 29, 1994. In this arrangement Respondent and C.L. had a chiropractic physician-patient relationship. Patient C.L. died on August 18, 1995. Respondent made a diagnosis, proposed a course of treatment and directly treated C.L. for AIDS. In this treatment Respondent maintained a patient record for C.L. In an effort to secure reimbursement for the services provided to C.L., Respondent prepared insurance claim forms, affixing a diagnosis of AIDS to the claim forms and had C.L. assign benefits to the Respondent from the insurance policy. In this connection Respondent had C.L. execute a sworn statement describing the services received from Respondent. It was Respondent's expectation that the claim forms would be honored by the insurance carrier and that Respondent would be paid for the services rendered to C.L. With one exception, Respondent's billings to the insurance carrier for C.L.'s visits to Respondent's office were all for the treatment of AIDS. An investigation was instituted by the State of Florida, Department of Business and Professional Regulation/ Agency for Health Care Administration to ascertain whether Respondent was offering patient treatment for AIDS. James Cooksey, an investigator with the regulator, performed that investigation in conjunction with Tom Willoughby, investigator for the Bay County, Florida, Sheriff's Office. James Cooksey is an insurance fraud/medical malpractice investigator. To conduct the investigation Mr. Cooksey assumed the fictitious name James Stark. The reason for assuming the name was to present James Stark as a patient suffering from AIDS. In furtherance of the investigation Mr. Cooksey went to the Tallahassee Memorial Regional Medical Center and obtained a fictitious positive AIDS test in the name James Stark. On May 16, 1994, Mr. Cooksey initiated contact with Respondent. The investigator traveled from Tallahassee to Panama City. When he reached Panama City he called Respondent and told Respondent that he needed to come and talk to him. Respondent invited Mr. Cooksey to come by that afternoon. On May 16, 1994, Mr. Cooksey met with Respondent at Respondent's office. At that meeting Mr. Cooksey told Respondent that the investigator understood that Respondent could possibly cure AIDS. Mr. Cooksey further stated that he had seen something in a newspaper article that Respondent was treating AIDS patients and explained to Respondent that Mr. Cooksey had contracted AIDS and was interested in being cured. Mr. Cooksey provided Respondent with the results of the fictitious blood test. When Mr. Cooksey presented to Respondent he did not complain of any condition other than AIDS. Respondent did not physically examine Mr. Cooksey. Respondent explained to Mr. Cooksey about the nature of Respondent's treatment in which the TENS unit, also known as a Rife machine, chondriana and life crystals would be used. To demonstrate the treatment Respondent took Mr. Cooksey into a room in the back of his office, a treatment room, and had Mr. Cooksey take his shoes and socks off and place his feet on a metal pad associated with the TENS unit. When the unit as turned on Mr. Cooksey could feel tingling inside his feet. On this occasion Respondent told Mr. Cooksey that, he, Mr. Cooksey could get injections of chondriana and then the machine would be turned on and Cooksey would receive stimulation to fight the infection associated with AIDS. Respondent told Mr. Cooksey that the initial treatments for AIDS would have to be done at his office where Respondent would monitor the investigator. Respondent indicated that a nurse would come to the office and give the injections of chondriana and that Mr. Cooksey would be monitored concerning those injections until Mr. Cooksey's "system built up a little". Mr. Cooksey understood that he was to receive those injections and use the TENS unit and was not to take other forms of medication during the treatment. Respondent gave Mr. Cooksey a card with the name of a blood test that would need to be obtained and the results reported to Respondent. Mr. Cooksey was responsible for paying for the blood test. Respondent told Mr. Cooksey that the life crystals were to be taken in orally as a drink and they were described as being part of the AIDS treatment. On this date Respondent gave the investigator an estimate of the costs of this treatment, constituted of $2,000 for the TENS unit and $2,925 for chondriana and life crystals. Subsequent to that date Respondent called Mr. Cooksey and left a message on Cooksey's telephone. Respondent also wrote the investigator on May 23, 1994, providing the investigator more information concerning Respondent's treatment for AIDS. The investigator then went to the state attorney's office in Panama City and informed the state attorney of the nature of the administrative investigation and the belief that the activities by Respondent might constitute a criminal law violation. The state attorney represented to the investigator that he concurred. The state attorney then had Mr. Cooksey contact the Bay County Sheriff's office. Following that contact Mr. Cooksey took up a joint investigation between Mr. Cooksey and Bay County Sheriff's investigator Tom Willoughby. On October 18, 1994, Mr. Cooksey placed a call to Respondent and told the Respondent that he was in Panama City and would like to come by and meet with the Respondent and that he would be accompanied by a friend who might be able to "come up" with the money that was required to purchase the chondriana and life crystals and TENS unit. The part of the friend was to be played by Officer Willoughby. Mr. Cooksey and Officer Willoughby then went to Respondent's office where Respondent again explained the nature of the AIDS treatment. Officer Willoughby asked the Respondent questions concerning the nature of the treatment and how much the treatment would cost. Respondent explained that the treatment involved injections of the chondriana, drinking the life crystals and using the TENS machine for two hours a day to treat James Stark for AIDS. At the October 18, 1994 meeting between the investigators and Respondent, Respondent stated that a nurse practitioner with whom he was friends would administer the chondriana and that activity would be monitored by Respondent in Respondent's office. Officer Willoughby asked Respondent if there would be side affects to the injections. Respondent indicated that there would be sweating and that Respondent would monitor Mr. Cooksey for whatever period of time would be necessary for the side affects to subside. The investigators watched a video tape explaining the treatment for AIDS which Respondent intended to employ. The injections of chondriana would be given monthly. Respondent indicated to the investigators that he would instruct Mr. Cooksey on how many of the life crystals to take. Respondent told the investigators that the cost of the TENS unit was $2,000.00 and that the unit would be used to spread the impulses through out the body. Respondent indicated to the investigators that the nature of the treatment would form new T-cells to replace T-cells containing the AIDS virus or which were cancerous. Respondent had stated in Officer Willoughby's presence that the TENS unit cost $500.00 to produce. Respondent and the two investigators then went to a local health food store, known as the Olive Leaf, to ascertain the amount of money needed to pay for chondriana which the health food store would provide. There, the attendant at the store indicated that he could arrange to provide the chondriana and life crystals for a price approximating $2,800.00. After leaving the health food store the investigators told the Respondent that they would come back with the necessary money on October 21, 1994. The investigators returned to Respondent's office on October 21, 1994, after obtaining warrants to search the office and arrest the Respondent. Before Respondent was arrested and the search made, the investigators asked Respondent to again explain the nature of the treatment that would be provided to Mr. Cooksey and paid Respondent $1,700.00 for the TENS unit from funds belonging to the Bay County Sheriff's Office. Respondent gave the investigators a receipt for the $1,700.00 payment. Respondent was then arrested for practicing medicine without a license. On one occasion Respondent explained to the investigators that the procedures that were used to treat Mr. Cooksey for AIDS were not condoned by the FDA, but that it was working in other places where it had been tried and that three patients treated in another location had gained remission from the AIDS. Based on the proof, it is found that Respondent diagnosed Mr. Cooksey as having AIDS and developed a course of treatment for that condition. Paul Doering, M.S., is a registered pharmacist in the State of Florida. He is also licensed as a consultant pharmacist in the State of Florida. He is a Distinguished Service Professor of Pharmacy Practice at the University of Florida. He is accepted as an expert pharmacist. Mr. Doering established that the drug AZT is an antiviral drug designed to address the HIV virus associated with AIDS. Mr. Doering established that AIDS is an acronym for acquired immuno- deficiency syndrome, "a disease that affects the immune system caused by a virus or different types of viruses which attack the immune system in the body rendering the body unable to effectively mount an immune response when it comes into contact with certain types of infectious organisms." Mr. Doering established that drugs are divided into two basic groups, one group which is sold without prescription and the other group requiring a doctor's prescription. The latter category of drugs are known as Federal Legend Drugs. Mr. Doering established that there is no reference to a medication known as "chondriana" in any directory of medications which he was familiar with. As he established, chondriana does not constitute a food because foods are not generally injected into the human body. Mr. Doering established that chondriana has not been approved to be used as a drug in the United States, nor is it an experimental drug, based upon his research of sources that list drugs or experimental drugs. Marianne Gengenbach, D.C., is licensed to practice chiropractic in Florida and is an expert in chiropractic practice. She established that chiropractors are limited to using proprietary drugs, and then only where the chiropractor has passed a specific exam and obtains a proprietary drug license. Proprietary drugs are "over the counter drugs" not prescription drugs. Absent such as a license to prescribe proprietary drugs chiropractors may only make recommendations, educate patients and prescribe nutritional supplements. Dr. Gengenbach established that Respondent had diagnosed C.L. for AIDS and had treated C.L. for that condition. The treatment was directly related to the condition AIDS, and Dr. Gengenbach established that the treatment was outside the accepted standard of care for chiropractic and exceeded the scope of authorized practice from the view point of a practitioner. As Dr. Gengenbach established, Respondent also exceeded the proper scope of practice in caring for C.L. by recommending that C.L. discontinue the AZT therapy. Those same perceptions were held for treatment of Mr. Cooksey and are accepted. Dr. Gengenbach established that Respondent proposed a course of treatment for Mr. Cooksey related to the condition AIDS, without reference to any other complaints by the patient. As a consequence the course of treatment which Respondent planned for Mr. Cooksey was directed solely to the HIV infection as established by Dr. Gengenbach. Dr. Gengenbach established that the use of the chondriana and life crystals was intended to treat Mr. Cooksey for AIDS. Dr. Gengenbach established that even should the substances chondriana and life crystals be considered food or nutritional supplements, there proposed use for Mr. Cooksey would not meet the prevailing standard of care for chiropractic, in that they would be employed for the treatment of AIDS. Respondent intended that the chondriana and life crystals be used in the cure, treatment, therapy and prevention of AIDS in C.L. and Mr. Cooksey. Respondent intended that those substances affect the structure and function of the bodies of those patients. In proposing and carrying out the treatment that has been described directed to AIDS, Respondent did so mindful that chiropractic physicians in Florida are prohibited from directly treating the AIDS condition. Respondent's treatment of C.L. and proposed treatment of Mr. Cooksey violated the standards of practice acceptable to a reasonably prudent chiropractic physician under similar conditions and circumstances and exceeded the scope of his chiropractic license. In the past Respondent has been disciplined by the Board of Chiropractic on three separate occasions. Two of those cases involve the receipt of a reprimand and in the third case Respondent's license was suspended and he was required to pay an administrative fine. Respondent was also required to cease and desist the activities described in these facts based upon action taken by the Board of Medicine, which was persuaded that Respondent was engaging in the treatment of AIDS without benefit of a medical license.
Recommendation Based upon the facts found and the conclusions of law reached, given the severity of the offense and the danger posed to the public, it is, RECOMMENDED: That a final order be entered which revokes Respondent's license to practice chiropractic medicine in Florida. DONE and ENTERED this 21st day of November, 1995, in Tallahassee, Florida. CHARLES C. ADAMS, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 21st day of November, 1995. APPENDIX CASE NO. 95-2881 The following discussion is given concerning the proposed findings of fact of the parties: Petitioner's Facts: Paragraphs 1 through 4 are subordinate to facts found. Paragraphs 5 and 6 constitute conclusions of law. Paragraphs 7 through 13 are subordinate to facts found. Paragraph 14 is not necessary to the resolution of the dispute. Paragraphs 15 through 35 are subordinate to facts found. Paragraphs 36 through 40 are conclusions of law. Paragraph 41 is subordinate to facts found. Paragraphs 42 and 43 are conclusions of law. Paragraphs 44 through 51 are subordinate to facts found. Respondent's Facts: Paragraphs 1 through 5 constitute legal argument as reported at pages 2 through 5. The proposed facts 1-3 found at pages 15 and 16, Paragraph 1 is contrary to facts found. Paragraph 2 is rejected as a discussion of activities of the Probable Cause Panel, not a proper subject for consideration. Paragraph 3 constitutes a conclusion of law. COPIES FURNISHED: Jon M. Pellett, Esquire Medical Quality Assurance-Allied Health Agency For Health Care Administration 1940 North Monroe Street, Suite 60 Tallahassee, FL 32399-0792 Curtis J. McCall, D.C. 514 North Bonita Avenue Panama City, FL 32401 Diane Orcutt, Executive Director Agency For Health Care Administration Board of Chiropractors 1940 North Monroe Street Tallahassee, FL 32399-0792 Jerome W. Hoffman, General Counsel Agency For Health Care Administration 2727 Mahan Drive Tallahassee, FL 32308
Conclusions An Administrative Law Judge with the Division of Administrative Hearings ("DOAH") submitted his Recommended Order of Dismissal to the Department of Environmental Protection ("DEP") in these consolidated administrative proceedings. The Recommended Order of Dismissal indicates that copies thereof were served upon counsel for the Co-Respondent, Escambia County Utilities Authority (“Authority”), and upon pro se Petitioners, Kerry Culligan (*Culligan’ ) Mary Pueschel Studstill (“Studstill’), and Chris Englert Cnglert. A copy. of the Recommended Ofder of Dismissal i is attached hereto as s Exhibit A The matter is now "before the Secretary o of DEP for final agency action. a | BACKGROUND The Authority owns and operates a public water system in Escambia County, Florida. These consolidated cases involve an application fi fi led with DEP seeking a permit to construct fluoridation treatment facilities at six of the Authority’s potable water a supply wells. On September 5, 2000. DEP executed an Intent to Issue and draft permit . } 4 F tor the Applicant’ fluoridation treatment construction project. The Petitioners then fi led “similar petitions with DEP contesting the issuance of the permit to the Applicant and requesting formal administrative hearings. The Petitions, which were forwarded to : r appropriate proceedings, basically questioned the safety and effi icacy of oe DOAH fc fluoridation i in their drinking water. Administrative Law w Judge, Donald R. Alexander, AL, was assigned to “~ insuffi cient to state a cause ofa action for relief f against DEP under the controling ‘provisions of Rule 62- 555. 328, Florida Administrative Code. Rule 62- 555. 325 establishes conditions and requirements for the issuance by of permits to public oO Bo yee ee water systems for the installation and operation of fluoridation treatment equipment. _ sad The ALS J recommended that DEP center a fi ina alorer dismissing, with prejudice, t the wale) eh as ed squares sas chante és antes? CONCLUSION The case law of Florida holds that parties to. formal administrative proceedings ‘must alert agencies to any perceived defects in DOAH hearing procedures or in the findings of fact of administrative law judges by filing exceptions to the DOAH recommended orders. See Couch v. Commission on Ethics, 617 So.2d 1119, 1124 (Fla. 5th DCA 1993); Florida Dept. of Corrections v. Bradley, 510 So.2d 1122, 1124 (Fla. 1st DCA 1987). The ALJ ruled in his Recommended Order of Dismissal that Petitioners’ allegations were legally insufficient to state a cause of action warranting denial of the construction permit for Applicant's proposed fluoridation treatment facilities. Nevertheless, no exceptions were filed by any of the Petitioners objecting to this critical adverse ruling or objecting to the ALJ’s ultimate recommendation that DEP enter a final order dismissing the three petitions with prejudice. Having considered the Recommended Order of Dismissal and other matters of record and faving | reviewed the applicable law, | concur with the rulings and ultimate recommendation of the ALJ. Itis therefore ORDERED: A. The ALJ’s Recommended Order of Dismissal is adopted in its entirety and is incorporated by reference herein. - B. Culligan’s amended petition for administrative hearing and the initial petitions for administrative hearings of Studstill and Englert are dismissed, with prejudice, for failure to state a cause of action upon which a final order can be entered denying the Authority’s requested permit to construct the fluoridation treatment facilities. seals Lae eee es i x A a Mk ii i ie aL C. DEP's Northwest District Office shall ISSUE to the Authority the construction permit for the fluoridation treatment facilities, subject to the terms and conditions of the draft permit issued in DEP File No. 0083021 -001 -WCIMA. Any party to these proceedings has the right to seek judicial review of this Final : pursuant “to Rife 9.110, Florida Rules of Appellate Procedure, ‘with the clerk of the Department in the Office of General Counsel, 3900 Commonwealth Boulevard, MS. 35, Tallahassee, Florida 32399-3000; and by filing a copy of the Notice of Appeal accompanied by the applicable fi iling fees with the appropriate District Court of Appeal. The Notice of ‘Appeal must be fi led within 30 days from the date ‘this Final Order is fi led ; with the clerk of the Department. -DONE AND ORDERED this Z day of January, 2001, in Tallahassee, Florida. bn STATE OF FLORIDA DEPARTMENT . OF ENVIRONMENTAL PROTECTION LS DAVID B. STRUHS Secretary Marjory Stoneman Douglas Building AOS OSU ue SAAS ai head. te 3900 Commonwealth Boulevard ; Tallahassee, Florida 32399-3000 moun i}76lo1 CERTIFICATE OF SERVICE | HEREBY CERTIFY that a copy of the foregoing Final Order has-been sent by United States Postal Service to: Kerry Culligan Mary Pueschel Studstill 814 North 13" Avenue 414 North Guillemard Street Pensacola, FL 32501 Pensacola, FL 32501 Chris Englert Robert W. Kievet, Esquire 4121 West Avery Avenue Kievet, Kelly & Odom Pensacola, FL 32501 15 West Main Street Pensacola, FL 32401 Ann Cole, Clerk and Donald R. Alexander, Administrative Law Judge David S. Dee, Esquire Division of Administrative Hearings John T. LaVia, Ill, Esquire The DeSoto Building Landers & Parsons, P.A. 1230 Apalachee Parkway Post Office Box 271 Tallahassee, FL 32399-1550 Tallahassee, FL 32302 and by hand delivery to: Craig D. Varn, Esquire Department of Environmental Protection . . 3900 Commonwealth Blvd., M.S. 35 ° “~~~ Tallahassee, FL 32399-3000 this LStkd ay of January, 2001. STATE OF FLORIDA DEPARTMENT OF ENVIRONMENTAL PROTECTION : “TERRELL WILLIAMS Assistant General Counsel ate ) Mhea 3900 Commonwealth Blvd., M.S. 35 Tallahassee, FL 32399-3000 “Telephone 850/488-9314 ce it 1a ea
