Findings Of Fact Dr. Rossario is a physician licensed by the Board of Medical Examiners of the State of Florida and specializing in the practice of psychiatry. Dr. Rossario was disciplined by the Halifax Hospital Medical Center staff, Executive Judicial Committee, for several grounds, among which were the failure to report a pending law suit on his annual application for renewal of staff privileges and engaging in sexual activities with a woman who was his patient contrary to the ethical standards of the staff of the Halifax Medical Center, in view of the relationship that must exist between a psychiatrist and his patient. A record of the proceeding against Dr. Rossario for the Halifax Hospital Medical Center Committee indicates that Halifax Hospital Medical Center Executive Committee found Dr. Rossario guilty of these two offenses. This record, however, did not state the factual basis upon which the committee reached its ultimate findings concerning each of the charges against Dr. Rossario. The testimony and documentary evidence presented by Dr. Rossario in the instant case show that the check for the annual renewal staff privileges for the application in which Dr. Rossario was found to have withheld notice of the pending suit was dated May 24, 1976. The service of process on that law suit shows that service was not obtained on Dr. Rossario until May 25, 1976. The testimony taken by the Executive Committee concerning submission of the application was vague and based on personal recollection. The cancelled check is considered a more reliable means of establishing the date. The admission of Dr. Rossario and his testimony revealed that Dr. Rossario first met Melissa Boone as a patient in May of 1974. He saw Melissa Boone several times professionally and an intimate relationship began to develop after three or four professional visits. Eventually, this culminated in an affair between Dr. Rossario and Melissa Boone which lasted from approximately June of 1974, until September of 1975. This affair resulted in sexual intimacy between Dr. Rossario and Melissa Boone, but this was in no way related to any therapy or treatment of Melissa Boone by Dr. Rossario. Their assignations did not take place at Dr. Rossario' s office. Dr. Rossario did not schedule any appointments with Melissa Boone after their affair began, but did see her in his office on several occasions when she came there on her own. On some of these occasions, prior to her seeing the psychiatrist to whom Dr. Rossario had referred her after their affair began, Dr. Rossario prescribed antidepressant drugs for Boone. Dr. Rossario was aware of the professional conflict in which his affair with Melissa Boone placed him. This was his reason for referring her to another psychiatrist. However, Dr. Rossario did not terminate the relationship because of fear of Melissa Boone's revealing it.
Recommendation In mitigation Dr. Rossario introduced the testimony of three medical experts, all psychiatrists, whose testimony generally was that Dr. Rossario had a character neurosis which made it difficult for him to differentiate between real relationships and the type of relationship based upon the neurotic needs of another. In the opinion of his primary treating physician, his character neurosis could not be "cured," but he had learned in essence how to compensate for it by learning about the nature of this type of relationship. Dr. Rossario has practiced and is now practicing as a general practitioner. The facts show Dr. Rossario engaged in sexual activity with a patient in the course of a relatively long-term affair unrelated to his treatment of this patient. Dr. Rossario's affair with his patient was brought on by his need for a close relationship and his character neurosis which made it difficult to differentiate between a real relationship and a relationship based upon the patient's neurotic needs. There is no evidence that Dr. Rossario consciously misused his status as the patient's physician to obtain the patient's sexual favors. What is presented, however, is a situation in which Dr. Rossario's character neurosis prevented him from recognizing transference which, according to expert testimony, occurs in all psychiatric therapy and which is basic to such therapy. While Dr. Rossario's physicians stated that he now understands transference as well as most psychiatrists, the real question is whether Dr. Rossario can compensate for his disability in this regard sufficiently to render competent health care to his patients. The affirmative answer to this question by the experts called by Dr. Rossario is not exhaustive and broad enough to be conclusive. Based on the foregoing findings of fact and conclusions of law, and matters presented in mitigation, the Hearing Officer recommends that the Board revoke Dr. Rossario's license to practice medicine with consideration of his relicensure upon Dr. Rossario's demonstrating to the Board that he can deliver competent health care in psychiatry or in any other area of practice for which he applies. DONE and ORDERED this 11th day of January, 1978, in Tallahassee, Florida. STEPHEN F. DEAN, Hearing Officer Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Robert Pierce, Esquire Suite 201 Ellis Building 1311 Executive Center Drive Tallahassee, Florida 32301 James E. Taylor, Jr., Esquire 29 East Pine Street Orlando, Florida 32801
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant facts are found: At all times material to this proceeding, the Respondent, Stacey Abo, was licensed in the State of Florida as a Registered Nurse (RN) holding license number 1457012. Presently, Respondent's license is in an inactive or lapsed status, having expired on March 31, 1987 without being renewed. Respondent was employed as a licensed RN at Memorial Hospital Memorial (Memorial) in Ormond Beach, Florida from May 1983 until her termination on July 5, 1985. During Respondent's tenure of employment at Memorial the Respondent: (a) was counseled on September 16, 1983 by Jackie Mirsky, Nursing Supervisor after it was reported to Mirsky by other nurses who did not testify at the hearing that they had smelled the odor of alcohol on Respondent's breath while she was on duty on September 6, 1983 and September 14, 1983; (b) was confronted by Sandra Peeples, charge nurse, on July 11, 1982 because Peeples suspected the odor of alcohol on Respondent's breath while she was on duty on June 11, 1984; (c) was terminated from her employment at Memorial on July 5, 1985, after it was reported to Johnette Vodenicker, Assistant Administrator, by another nurse, who did not testify at the hearing, that she had smelled the odor of alcohol on Respondent's breath on July 4, 1985 and, for having been counseled on September 16, 1983 and June 11, 1984 in the same regard. Peeples "thought" she smelled alcohol on Respondent's breath on June 11, 1984. Respondent admitted having "a beer" with lunch but there is insufficient evidence to show that Respondent had the odor of alcohol on her breath while on duty on September 6, 1983, September 14, 1983, July 4, 1985 or at any other time while she was on duty, other than June 11, 1984. The Respondent was employed as a licensed RN at Halifax Medical Center (Halifax) in Daytona Beach, Florida, from November, 1985 until her termination on October 8, 1986. Sometime in December, 1985, shortly after being employed at Halifax, the Respondent attempted suicide by ingesting several different drugs and, was hospitalized at Halifax for approximately two (2) weeks. Because of the suicide attempt, Respondent was referred to counseling. Respondent attended counselling session with Dr. Abed. It was understood that she could return to work on Dr. Abed's recommendation. Sometime around January 1, 1986 Respondent was allowed to return to work as a concentrated care unit nurse on the condition that Respondent continue counseling until released by Dr. Abed. There is insufficient evidence to establish how Halifax was to be notified of Respondent's continued counseling or the frequency of such notification. Halifax was never notified by Dr. Abed that Respondent had been released from treatment. Respondent's notification of her counseling with Dr. Abed was sporadic, however there was insufficient evidence to establish that such notice was not in accordance with the understanding between Halifax and the Respondent. There was insufficient evidence to establish the reason for Respondent's suicide attempt or that such suicide attempt resulted in Respondent being unable to practice nursing with reasonable skill and safety to patients except for the two (2) week period she underwent counseling with Dr. Abed. Respondent was reported to Judith Ann Clayton, nurse manager, intensive surgical center, Halifax Medical Center, for numerous errors which involved administering and monitoring "I.V's" to patients on May 15, 1986 (Petitioner's Exhibits No. 5- A) and May 19, 1986 (Petitioner's Exhibits 5-B through 5-E) by nurses who came on duty on the next shift immediately after Respondent`s shift. Somewhere around the time of the "I.V." incidents, Respondent was observed by Clayton as having the odor of alcohol on her breath while on duty. When confronted by Clayton, the Respondent admitted having had "a beer" with lunch. There is insufficient evidence to show if Respondent was ever counselled or disciplined by the hospital for this incident. As a result of these reported errors involving improper administration and monitoring of "I.V.`s" to patients and, having the odor of alcohol on her breath while on duty, Respondent was placed on medical leave of absence for two (2) months. During these two (2) months, Respondent was provided counseling by Halifax with the understanding that at the end of counseling Halifax would determine her status. During Respondent's medical leave of absence she attended counselling and was allowed to return to work with a limited work assignment on June 30, 1986 on the neurological surgical unit under the supervision of Jean R. Snodgrass. At the beginning, Respondent's duties did not include administering and monitoring "I.V.`s", administering other medication or signing off orders in the patient's chart. However, on October 8, 1986, Respondent was responsible for administering medication and administering and monitoring "I.V.`s". On October 8, 1986, Respondent, while fully responsible for fourteen (14) or fifteen (15) patients, left and did not return to her assigned station on the neurological surgical unit during her scheduled shift. Respondent failed to notify the proper authority or anyone else of her departure and without securing a replacement, thereby abandoning her patients. Due to Respondent's abandonment of her patients, Halifax terminated her employment on October 8, 1986. By abandoning her patients on October 8, 1986, Respondent failed to conform to minimum standards of acceptable and prevailing nursing practice and was not practicing nursing safely.
Recommendation Having considered the foregoing Findings of Fact and Conclusions of Law, the evidence of record and the candor and demeanor of the witnesses, it is, therefore RECOMMENDED that the Board of Nursing enter a Final Order finding the Respondent guilty of violating Section 464.018(1)(f), Florida Statutes and that Respondent's nursing license be suspended for a period of one (1) year, stay the suspension, place the Respondent on probation for a period of three (3) years under the condition that Respondent undergo psychological counseling and any other condition the Board may deem appropriate, and assess an administrative fine of $300.00 to be paid within ninety (90) days of the date of the Final Order. Respectfully submitted and entered this 16th day of October, 1987, in Tallahassee, Leon County, Florida. WILLIAM R. CAVE Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 FILED with the Clerk of the Division of Administrative Hearings this 16th day of October, 1987. APPENDIX TO RECOMMENDED ORDER IN CASE NO. 87-2232 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the Petitioner in this case. Rulings on Proposed Findings of Fact Submitted by the Petitioner Adopted in Finding of Fact 1. Adopted in Finding of Fact 2. 3.-4. Adopted in Finding of Fact 3. 5.-6. Rejected as hearsay that is uncorroborated by any substantial competent evidence. Adopted in Finding of Fact 5. Adopted in Finding of Fact 11. Rejected as not supported by substantial competent evidence in the record. Adopted in Finding of Fact 6. Adopted in Finding of Fact 9 but clarified. Adopted in Finding of Fact 7 but clarified. The first sentence is rejected as not supported by substantial competent evidence. The second sentence is rejected as hearsay uncorroborated by any substantial competent evidence. The third sentence is adopted in Finding of Fact 7. 14.-15. Rejected as hearsay uncorroborated by any substantial competent evidence. Adopted in Finding of Fact 12 but clarified. Adopted in Finding of Fact 13 but clarified. Rejected as not supported by any substantial competent evidence. Additionally, it is rejected as not being relevant or material. Adopted in Finding of Fact 14. Adopted in Finding of Fact 15. Rejected as not supported by any substantial competent evidence. Rulings on Proposed Findings of Fact Submitted by the Respondent The Respondent did not submit any proposed findings of fact. COPIES FURNISHED: Lisa M. Bassett, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Stacey Abo 12 Riverdale Avenue R.R. No. 2 Ormond Beach, Florida 32074 Tom Gallagher, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Judie Ritter, Exec. Director Board of Nursing Department of Professional Regulation Room 504, 111 E. Coastline Dr. Jacksonville, Florida 32201
The Issue The issue in this case is whether notice was accorded the patient, as contemplated by section 766.316, Florida Statutes (2012).
Findings Of Fact Ashley Lamendola first presented to Gulf Coast OB/GYN on the morning of December 16, 2011, for a prenatal visit. This visit constituted the beginning of her professional relationship with the physicians who were part of the Gulf Coast OB/GYN group, which included Dr. Calderon and Dr. Shamas.1/ Violet Lamendola, Ms. Lamendola’s mother, accompanied Ms. Lamendola to that visit. When she arrived at Gulf Coast OB/GYN, Ms. Lamendola was given information and forms to fill out by the receptionist. According to both Ms. Lamendola and her mother, the materials included a NICA brochure in Spanish and an acknowledgment of receipt of the NICA form. While reviewing the materials, Ms. Lamendola, who does not speak Spanish, noted that the NICA brochure given to her was in Spanish. She asked her mother to take the brochure back to the receptionist. When Ms. Lamendola’s mother asked the receptionist about the Spanish brochure, the receptionist told her that the office had run out of NICA brochures printed in English, but that she would obtain one from another office and give it to Ms. Lamendola at the end of her appointment. Ms. Lamendola was instructed to sign and did sign the acknowledgment form so that she could see the physician. The acknowledgment form advised that all physicians in the Gulf Coast OB/GYN, P.A., were participating physicians in the NICA program. Ms. Lamendola received a black-and-white facsimile copy of the NICA brochure on her way out of the office along with other materials relating to prenatal and infant care. The brochure, received by Ms. Lamendola from Gulf Coast OB/GYN, bears a facsimile transmission header dated December 16, 2011, at 9:47 a.m. The brochure prepared by NICA is a color brochure which contains the following text in white letters on a light-to-medium green background on the back of the brochure: Section 766.301-766.316, Florida Statutes, (“NICA Law”) provides rights and remedies for certain birth-related neurological injuries and is an exclusive remedy. This brochure is prepared in accordance with the mandate of Section 766.316, Florida Statutes. A copy of the complete statute is available free of charge to completely inform patients of their rights and limitations under the application provision of Florida law. Since 1989, numerous court cases have interpreted the NICA law, clarifying legislative intent. The above-quoted language is absent from the facsimile copy of the brochure that Ms. Lamendola received from Gulf Coast OB/GYN. Apparently because the letters in the original brochure were white, the letters did not transmit. It is noted that on the front of the brochure, white lettering that appears on the green background of the color brochure did not transmit on the copy that Ms. Lamendola received. The majority of the information contained in Ms. Lamendola’s facsimile copy of the brochure is contained in the color copy of the brochure. The facsimile copy informed Ms. Lamendola that the statutes provide an exclusive remedy and a copy of the statutes may be obtained from NICA. The facsimile outlined the rights and limitations provided in the statutes. The only things that are not contained in the original brochure are that a copy of the statutes is available free of charge, the preparation of the brochure was mandated by section 766.316, and court cases have interpreted the statutes. St. Petersburg General Hospital offers a tour of its obstetrical department to expectant mothers and their families. Ms. Lamendola’s mother called St. Petersburg General Hospital to register for a tour. The hospital employee who was scheduling the tour asked to speak to Ms. Lamendola to obtain pertinent biographical information. Ms. Lamendola provided the information to the hospital employee. The tour is an informational tour and attendance at the tour does not constitute pre-registration at St. Petersburg General Hospital for the delivery of a baby. Ms. Lamendola and her mother, along with 12 other couples, attended the tour on March 22, 2012. During the tour, Ms. Lamendola received a tour packet, which contained a document titled Preadmission and Financial Information. This document instructed Ms. Lamendola to fill out the pre-admission form and return it to the hospital. Ms. Lamendola filled out the pre- admission form, but did not return it to St. Petersburg General Hospital. Ms. Lamendola did not pre-register for admission to the hospital. On April 3, 2012, Ms. Lamendola presented to St. Petersburg General Hospital with complaints of vaginal bleeding. Ms. Lamendola was told by a hospital employee that she was already in the system and that additional information would not be necessary. Ms. Lamendola signed a “Consent to Treat” form and was treated in the labor and delivery unit of the hospital. A short time later, she was given informational materials relating to prenatal and infant care and released. She was not given a NICA brochure during the visit on April 3, 2012. It was the hospital’s policy to give a NICA brochure to a patient only when the patient was being admitted as an inpatient for delivery of her baby. Ms. Lamendola’s professional relationship with St. Petersburg General Hospital relating to her pregnancy began with her visit on April 3, 2012. At 20:19 on June 26, 2012, Ms. Lamendola presented to St. Petersburg General Hospital. She had been experiencing contractions for six hours prior to her arrival at the hospital. She had been placed on bed rest for gestational hypertension five days prior to coming to the hospital. When she arrived at the hospital, she had hypertension. Normally when a patient is 37 to 39 weeks gestation, her physician will bring the prenatal records to the hospital or the physician’s office will send the records to the hospital by facsimile transmission. When Ms. Lamendola arrived at St. Petersburg General Hospital, her prenatal records from her physicians’ office were not on file. Megan Muse, R.N., was on duty when Ms. Lamendola presented at St. Petersburg General Hospital. Because Ms. Lamendola’s records were not on file, Ms. Muse requested that Bayfront Hospital send Ms. Lamendola’s records to St. Petersburg General Hospital. The evidence did not establish how Ms. Muse knew that the prenatal records were at Bayfront Hospital. Ms. Lamendola’s prenatal records, consisting of 11 pages, were sent by facsimile transmission to St. Petersburg General Hospital beginning at 21:35 on June 26, 2012. Ms. Muse recorded in her notes that Ms. Lamendola’s prenatal records were received from Bayfront Hospital at 21:45 on June 26, 2012. Although Ms. Lamendola’s prenatal records may have been sent to Bayfront Hospital, it was never Ms. Lamendola’s intention to deliver her baby at Bayfront Hospital. She took the informational tour offered by St. Petersburg General Hospital and went to St. Petersburg General Hospital in April 2012 when she had a problem related to her pregnancy. At 20:33, Dr. Javate admitted Ms. Lamendola to St. Petersburg General Hospital for the delivery of her infant. Ms. Lamendola was examined by Emanuel Javate, M.D., at approximately 21:35. At 22:02, Ms. Lamendola signed the hospital’s Condition of Admission form. At 22:10 the hospital gave Ms. Lamendola the brochure prepared by NICA, and Ms. Lamendola signed the acknowledgment form, acknowledging that she had received the brochure. Ms. Lamendola gave birth to Hunter Lamendola (Hunter) on June 27, 2012, at St. Petersburg General Hospital, which is a licensed Florida Hospital. At birth, Hunter weighed in excess of 2,500 grams and was a single gestation. Ashley Lamendola received obstetrical care from Guillermo Calderon, M.D. Dr. Calderon was a “participating physician” as defined in section 766.302(7). Christina Shamas, M.D., provided obstetrical services in the course of labor, delivery, and resuscitation in the immediate post-delivery period. Dr. Shamas was a “participating physician” as defined in section 766.302(7).
Findings Of Fact In March 1975, Respondent was employed as a registered nurse at the Sarasota Memorial Hospital, Sarasota, Florida. On March 26, 1975, he was performing duties as "charge" nurse on the 3 P.M. to 11 P.M. shift in the Orthopedic Clinic. At approximately 4 P.M., Muriel Johnson, R.N., Clinical Supervisor, while making her initial rounds for the shift, talked to two of the patients who indicated they felt no need for medication and had not received any. She then observed that the patients' medication and treatment sheets indicated that Respondent had given them Percodan, a narcotic drug, that afternoon. She then checked Respondent's nurses notes and the federal narcotic control sheet used to keep track of narcotics on the floor, and found no entries for the patients in question on either document. Both of these documents should have reflected the administration of medication to the patients at the time it was given. She proceeded to report the apparent discrepancy to her supervisor. (Testimony of Johnson) The Sarasota police was notified and two police officers arrived at the hospital about 11:15 P.M.. They were informed by a nurse that Respondent was suspected of checking out narcotics, but not issuing them to patients. Based on the foregoing information, they followed Respondent's automobile as he left the hospital that evening and stopped it about a quarter of a mile south of the hospital on US highway 41. Respondent's wife was driving the automobile at the time. Respondent was placed under arrest and, upon a search of his person, various drugs in hospital containers or packages were discovered, including seven Percodan tablets, six Synalgos DC capsules, and two Empirin with Codeine tablets. Percodan is a controlled Schedule 1 drug used to relieve pain and Synalgos DC is a Schedule 3 drug. Respondent was cooperative at the time of his arrest. He was charged with three counts of illegal possession of drugs and, on September 12, 1975, in the Sarasota County Circuit Court, Case No. 75-229-CF-A- 01, upon a plea of Nolo Contendere, adjudication of guilt was withheld and Respondent was placed on probation for two years, fined $1,000.00, and ordered to undergo psychiatric counselling. (Testimony of Hogle, Peterson, Perry, Petitioner's Exhibit 1,2, Composite Exhibit 3). On March 12, 1975, at the Sarasota Memorial Hospital, Respondent signed for 1 capsule of Chloral Hydrate, 300 mg. for a patient named Lena J. Herman. He indicated on the narcotic and barbituate administration record number 126951 that the medication was refused and destroyed. Hospital policy as set forth in written procedures provides that destruction of narcotics or barbituates must be witnessed and countersigned on the narcotics and barbituate administration record by another nurse. No such witnessing signature was shown on number 126951. (Testimony of Kuebler, Petitioner's Composite Exhibit 5). On March 13, 1975, at 8:00 P.M., at the Sarasota Memorial Hospital, Respondent signed out 1 tab of Demerol, 50 mg. for a patient named Herman on narcotic and barbituate administration record number 128232, and on the same date and the same hour for the same patient signed out for another tab of Demerol, 50 mg. on narcotic and barbituate administration record number 128097. The medication record and nursing notes for that patient on the date in question show that only one of the tablets was administered by Respondent to the patient subsequent to signing it out. (Testimony of Kuebler, Petitioner's Composite Exhibits 4 & 5). Respondent was an excellent nurse who had been employed at the Sarasota Memorial Hospital for over one year. He was dependable and took good care of his patients. (Testimony of Johnson, Kuebler, Bowden, Respondent's Composite Exhibit 1). Respondent has received comprehensive alcoholism counseling and treatment in state facilities and at the First Step of Sarasota, a counseling and treatment center. He recognizes his problem with alcohol and has managed to keep it under control while living at First Step with the assistance of the drug Antabuse. He has helped at First Step with other patients and the Executive Director there would like to hire him as a nurse when an opening occurs. He has been a cooperative and cheerful probationer in the opinion of his probation officer. (Testimony of Bowden, Ves'sells, Clark).
Recommendation That the license of Faris E. Moyer to practice as a registered professional nurse be revoked for unprofessional conduct, in violation of Section 464.21(1)(b), Florida Statutes. DONE and ENTERED this 12th day of August, 1976, in Tallahassee, Florida. THOMAS C. OLDHAM Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Julius Finegold, Esquire 1330 American Heritage Building Jacksonville, Florida 32202 Robert J. Elkins, Esquire 2187 Siesta Drive Post Office Box 15425 Sarasota, Florida 33579
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.
