STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
AGENCY FOR HEALTH CARE ) ADMINISTRATION, )
)
Petitioner, )
)
vs. ) CASE NO. 94-2941
) LEONARD E. MASTERS, M.D., )
)
Respondent. )
)
RECOMMENDED ORDER
Pursuant to notice, a formal hearing was held before the Division of Administrative Hearings and its duly designated Hearing Officer, Suzanne F. Hood, on July 11, 12, and 18, 1995, in Jacksonville, Florida.
APPEARANCES
For Petitioner: Albert Peacock, Senior Attorney
Agency for Health Care Administration 1940 North Monroe Street, Suite 60
Tallahassee, Florida 32399
For Respondent: Alex D. Barker
Elaine Lucas
Donald W. Weidner, P.A.
10161 Centurion Parkway North, Suite 190
Jacksonville, Florida 32256 STATEMENT OF THE ISSUE
Whether disciplinary action should be taken against Respondent's license to practice medicine, license number ME 0009841, based on the violation of Section 458.331(1)(t), Florida Statutes, as alleged in the Administrative Complaint filed in this proceeding.
PRELIMINARY STATEMENT
On December 15, 1993, Petitioner Agency for Health Care Administration (Petitioner), formerly known as Department of Business and Professional Regulation, filed an Administrative Complaint against Respondent Leonard E. Masters, M.D. (Respondent), alleging that he violated Section 458.331(1)(t), Florida Statutes. The Administrative Complaint specifically alleges that Respondent practiced medicine below the standard of care because he failed to refer four (4) patients to a psychiatrist or addictionologist while continuing to treat the patients with narcotic medications even though they failed to improve with treatment.
On or about January 7, 1994, Respondent requested a formal hearing pursuant to Section 120.57(1), Florida Statutes. Petitioner referred this matter to the Division of Administrative Hearings for assignment of a Hearing Officer on May 26, 1994. Hearing Officer David M. Maloney issued a Notice of Hearing and an Order of Prehearing Instructions on July 1, 1994. Hearing Officer Maloney initially set this matter for hearing on December 15 and 16, 1994.
On July 25, 1994, Petitioner filed an unopposed Motion to Reschedule Hearing. Hearing Officer Maloney issued an Order Granting Continuance and Rescheduling Hearing on August 8, 1994. The hearing was rescheduled for February 23 and 24, 1995.
Respondent filed an unopposed Motion to Reschedule Hearing on January 10, 1995. Hearing Officer Maloney issued a Second Order Granting Continuance and Rescheduling Hearing on January 25, 1995. This matter was rescheduled for hearing on July 11 and 12, 1995.
On June 28, 1995, the parties filed a Pre-Hearing Stipulation. The formal hearing was held before the undersigned on July 11 and 12, 1995, and continued by video teleconference on July 18, 1995, in Jacksonville, Florida. At the formal hearing, prior to testimony of the witnesses, the undersigned granted Petitioner's Motion for Official Recognition of Sections 465.003(7) and 893.03, Florida Statutes, and 21 Code of Federal Regulations 1306 (1983-1991).
Petitioner presented the expert testimony of Reynold M. Stein, M.D., and Neville S. Marks, M.D. The undersigned overruled Respondent's objection to the expert testimony of Dr. Marks. Petitioner offered eleven (11) exhibits into evidence, all of which were accepted into evidence.
Respondent testified on his own behalf and presented the testimony of Thomas A. Tomlin, M.D. and Michael Poland and the expert testimony of Mitchell
Max, M.D. At the hearing, the undersigned reserved ruling on Petitioner's objection to the expertise of Dr. Max. Having considered the parties' written and oral argument, Petitioner's objection is overruled and Dr. Max is hereby accepted as an expert witness in this case. Respondent offered five (5) exhibits into evidence, all of which were admitted into evidence.
The final volume of the hearing transcript was filed with the Division of Administrative Hearings on August 4, 1995. On August 8, 1995, the undersigned issued an order extending the time to file proposed recommended orders. Both parties filed their proposed findings of facts and conclusions of law on August 31, 1995. Specific rulings on each of the parties's proposed findings of fact are contained in the Appendix to this Recommended Order.
FINDINGS OF FACT
Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.30 and Chapters 455 and 458, Florida Statutes.
Respondent is and has been, at all times material to this complaint, a licensed physician in the state of Florida, having been issued license number ME 0009841 on August 1, 1961.
Respondent is and has been board certified in family practice since 1970. He was a charter member of the American Academy of Family Physicians. He has served as President of the Florida Academy of Family Physicians and the Duval County Academy of Family Practice.
Dr. Masters was engaged in a solo private family practice from 1962 until 1971.
From 1971 through 1973, Respondent was an Assistant Professor for the University of Florida and served as Director of the Family Practice Residency Program at St. Vincent's Medical Center in Jacksonville, Florida. From 1974 to 1978, Respondent was an Associate Professor for the University of Iowa and served as Director of the Family Practice Residency Program at Iowa Lutheran Hospital in Des Moines, Iowa. In 1978 Respondent began working as Associate Professor and Chairman of Research at East Carolina University School of Medicine in Greenville, North Carolina.
In 1981 Respondent returned to private practice in Jacksonville, Florida, as Director of the North Beaches Family Practice and Acute Care Center. Respondent currently works at the Family Care Center in Jacksonville, Florida, where he has practiced since 1989.
Respondent has conducted extensive research on issues relating to family practice and published many articles based on his research and experience. One of Respondent's publications is "Automated Medicated Lists for Use with the Problem Oriented Medical Record" published in the Journal of Family Practice, Vol. 4, No. 3, 1977. He also coauthored the chapter, "Psychotherapy and Behavior Modification," in Conn and Rakel's text for family practice, entitled, Family Practice. In this text the Respondent asserted that a "consultation with a psychiatrist should be considered when the physician feels that his sessions with the patient are unrewarding or when the patient presents very complicated psychologic problems or when the physician feels very uncomfortable with the patient and his problems. Such consultations can be requested either to have the psychiatrist offer suggestions about how the family physician should proceed with counseling or to have the psychiatrist rather than the family physician continue appropriate psychotherapy."
Respondent provided medical care to patients C.A., C.B., C.M., and D.R. from 1983 until 1990.
Demerol is a legend drug as defined by Section 465.003(7), Florida Statutes, and contains meperidine, a schedule II controlled substance listed in Chapter 893, Florida Statutes.
Phenergan is a legend drug as defined by Section 465.003(7), Florida Statutes, and contains codeine, a schedule III controlled substance listed in Chapter 893, Florida Statutes.
Xanax is a legend drug as defined by Section 465.003(7), Florida Statutes, and contains alprazolam, a schedule IV controlled substance listed in Chapter 893, Florida Statutes.
Mepergan is a legend drug as defined by Section 465.003(7), Florida Statutes, and contains meperdine, a schedule II controlled substance listed in Chapter 893, Florida Statutes.
Darvocet is a legend drug as defined by Section 465.003(7), Florida Statutes, and contains propoxyphene, a schedule IV controlled substance listed in Chapter 893, Florida Statutes.
Tylox is a legend drug as defined by Section 465.003(7), Florida Statutes, and contains oxycodone, a schedule II controlled substance listed in Chapter 893, Florida Statutes.
Methadone is a legend drug as defined by Section 465.003(7), Florida Statutes, and is a schedule II controlled substance listed in Chapter 893, Florida Statutes.
Dolophine is a legend drug as defined by Section 465.003(7), Florida Statutes, and contains methadone, a schedule II controlled substance listed in Chapter 893, Florida Statutes.
Fiorinal is a legend drug as defined by Section 465.003(7), Florida Statutes, and contains butalbital, a schedule III controlled substance listed in Chapter 893, Florida Statutes.
FINDINGS OF FACT AS TO PATIENT C.A.
Patient C.A. was born in 1957. She initially presented to Respondent for an office visit on April 18, 1983, with a history of headaches. C.A. advised Respondent that she had a complete work-up including an EEG, a CAT scan and a skull x-ray in Connecticut in 1981. She was on Inderal for hypertension and migraine headaches. However, the medication had not been effective for the migraine headaches which were becoming more frequent, worse on the left side, and associated with nausea and vomiting. Respondent increased C.A.'s Inderal, prescribed Mepergan Forte, and gave her an injection of Demerol 75 and Phenergan
50 in the office.
C.A. returned on May 4, 1983, with increasing headaches. Respondent prescribed Imipramine, 50 mg., for C.A. and discussed obtaining her prior medical records and work-ups to decide if any further testing was necessary.
On May 19, 1983, Patient C.A. had an acute headache on the left side. Respondent admitted her to Baptist Beaches Hospital. He requested a neurology consult and an ophthalmology consult.
The ophthalmologist felt the exam was negative except for some small microaneurysms in the nacular area secondary to hypertension. The ophthalmologist did not think further treatment was necessary, except to maintain C.A. on the medications for control of her hypertension. The neurologist indicated that Respondent might want to consider treating C.A. for substance abuse.
Prior to C.A.'s discharge from Baptist Beaches Hospital, Respondent recommended that C.A. enter the Care Unit, an inpatient substance abuse facility. Because C.A. refused Respondent's recommendation, he discharged her from Beaches Hospital and agreed to follow her in the office and at home.
Respondent continued to treat C.A. with an emphasis on identifying the cause of her depression and controlling the stress factors which contributed to her migraine headaches. Respondent prescribed Mepergan Forte and Imipramine which appeared to provide some relief for C.A.'s pain.
On August 17, 1983, Respondent referred C.A. to Dr. Wilde, a local psychologist, for biofeedback, and again referred her to Dr. Wilde for counseling on August 20, 1983.
On August 31, 1983, C.A. informed Respondent that she had started the biofeedback program with Dr. Wilde. Respondent advised C.A. that she would have to continue in the program in order to receive further treatment; otherwise, Respondent would taper off the medicine and require her to seek another physician. C.A. agreed to continue the therapy. Respondent prescribed a low dosage of Methadone (5 mg) to be taken twice a day for relief of the pain.
C.A. continued with the biofeedback therapy. She received Demerol and Phenergan shots during her office visits. Respondent prescribed a limited amount of Methadone until December, 1983.
On December 15, 1983, Respondent noted that C.A. had probably gotten all she could from the biofeedback for the short-term. He determined that after the holidays C.A. would need to get into counseling.
C.A. visited Respondent's office once in January and twice in February of 1984. Around this time, C.A. began suffering blackout spells. Her next office visit was May 17, 1984. She informed Respondent that she had a seizure while out-of-town and that another physician prescribed Dilantin for her seizure disorder.
During June of 1984, C.A. discontinued the use of analgesics but continued her other medications. On June 30, 1984, Respondent recommended that
C.A. join a wellness center and begin a regular exercise program. Respondent limited C.A.'s Demerol by dosage and time. On July 19, 1984, a neurological exam was conducted and determined to be negative.
Over the next year, C.A. returned to Respondent's office on nine occasions. She identified numerous stress factors that contributed to her headaches and depression. Respondent counseled C.A. during these visits and assisted her in facing the issue of a childhood rape. He also helped her deal with financial and marital problems over the next two years.
C.A. returned to Respondent's office complaining of headaches in September and December of 1985, and in March, June, August, September, November and December of 1986. In February, 1987, Respondent discussed additional ways for C.A. to deal with her life stresses including exercise and relaxation techniques. She continued on a monthly basis with Respondent through 1987, improving on some visits and complaining of new stress factors on other visits.
In December, 1987, Respondent counseled C.A. and her husband about C.A.'s increased use of narcotics. Respondent informed C.A. that he would begin decreasing her prescriptions and force her to use other alternatives for relieving the migraine headaches.
In February of 1988, Respondent advised C.A. that he would terminate her Demerol prescription and replace it with Methadone. C.A. refused Respondent's offer of Methadone. She became irate and uncooperative with Respondent and his staff. C.A. cut her wrists in an attempt to force Respondent to provide Demerol prescriptions. Recognizing this behavior as indicative of addiction, Respondent maintained his position and told C.A. she would not receive any more Demerol prescriptions unless she complied with his program of non-narcotic treatment. On February 26, 1988, Respondent gave C.A. her last injection of Demerol and set up a plan for C.A. to gradually stop using Demerol altogether.
C.A.'s last visit to Respondent's office was on March 5, 1988. Respondent refused to prescribe Demerol and again offered Methadone which C.A. refused.
During the course of treatment, Respondent became aware that C.A. suffered from hypertension, pancreatitis, migraine headaches, seizure disorder, chemical dependency, depression and psycho sexual dysfunction. Respondent prescribed various medication for C.A., including Demerol, Phenergen, Xanax, and Mepergan Fortis.
In addition to prescribing various medications to treat C.A.'s complaints of pain associated with migraine headaches, Respondent provided C.A. with counseling for her depression. As a result of Respondent's care and attention, C.A. was able to: (a) maintain relationships with others; (b) acknowledge and deal with the trauma resulting from her abusive childhood experiences; (c) acknowledge and deal with the trauma resulting from being a victim of a sexual assault staged by her husband; (d) assist her family in accepting her brother's terminal AIDS condition; and (e) renew a relationship with her parents, after a long estrangement.
All narcotics that Respondent prescribed for C.A. were within acceptable dosages and administered in a controlled manner.
Competent substantial evidence indicates that Respondent appropriately prescribed, dispensed and administered medications for C.A.
C.A. had severe personality disorders. Respondent never referred C.A. for a psychiatric consultation. He never sought the advice of a psychiatrist concerning C.A.'s treatment. However, Respondent did refer C.A. to an ophthalmologist, neurologist and psychologist.
Referral of C.A. to a psychiatrist or addiction specialist was unnecessary because Respondent properly handled C.A.'s psychological and physiological problems.
Petitioner's expert, Dr. Stein, reviewed the medical records that Respondent kept on C.A. and issued his first written opinion on October 16, 1992. In this report, Dr. Stein acknowledged that Respondent's medical records were "overly sufficient," and included "objective findings, assessments and plans."
In his October 16, 1992 report, Dr. Stein opined that Respondent pursued the appropriate plan of treatment for C.A. and, "despite the fact that narcotics were continuously needed to control the patient's chronic migraine headaches, he [Respondent] always attempted alternative treatments including prophylactic use of Inderal, psychologic counseling, biofeedback, and antidepressants."
C.A. was not the typical patient with migraines or the typical office patient. It would have been easier for Respondent to tell C.A. to go elsewhere. However, with Respondent's help, C.A. was able to cope with her chronic pain for almost five years. According to Dr. Stein's October 16, 1992, report, Respondent made the "proper therapeutic decisions with each visit".
In 1992, Dr. Stein concluded that Respondent did not inappropriately prescribe or dispense medications to C.A. and that Respondent met "the applicable standard of care in this patient as would have been done by another
similar and prudent physician with this same patient under the same circumstances had that physician continued to treat this patient for the time mentioned."
Dr. Stein's opinions set forth in his subsequent written opinion dated December 7, 1992, and his testimony at the formal hearing contradict his written opinion dated October 16, 1992. The undersigned finds the October 16, 1995, report more persuasive.
FINDINGS OF FACT AS TO PATIENT C.B.
Patient C.B., a nurse midwife, was born in 1947. She received general and gynecological care from Respondent's family practice group in 1983 and 1984. In April, 1984, C.B. was involved in a car accident and received a head injury. She received treatment from the family practice group until February, 1986, when Respondent's associate referred C.B. to Respondent for treatment of her increasing migraines. The physician treating C.B. on February 27, 1986, noted that she had scarring on her buttocks region.
Respondent first saw C.B. for increasing migraines and general body pain on March 19, 1986. Respondent conducted an extensive interview with C.B. concerning her social and medical history. He noted that she was a drug abuser and obviously depressed. Respondent decided to continue her on the narcotics previously prescribed for her.
Due to her depression, Respondent counseled with C.B. over the next several months and gave her a prescription for Elavil. C.B.'s condition continued to improve.
In June, 1986, Respondent referred C.B. to a local headache clinic.
C.B. cancelled her appointment with the headache clinic, explaining that she was familiar with all the physicians and was embarrassed.
C.B. missed several appointments with Respondent in June, 1986. On July 1, 1986, Respondent confronted C.B. regarding the numerous lesions found on her arms and legs. She admitted that she had been self-administering Phenergan since March for relief of pain. C.B. obtained Phenergan through her employment as a midwife.
For the next month, Respondent continued to counsel with C.B. He decreased her use of antidepressants as her depression was under control. C.B. was doing better and using less medication. The lesions on her arms and legs began to heal. She was now able to distinguish between tension and migraine headaches.
In August of 1986, C.B. agreed to reschedule her appointment with the headache clinic and change her work schedule to reduce the stress factors in her life.
During the next six months, Respondent continued to counsel C.B. He also began giving her prescriptions for Methadone. Respondent gradually reduced C.B.'s Demerol intake. By April, 1987, Respondent was aware that C.B. was using the Demerol as a crutch.
C.B.'s mental condition improved and the depression subsided. On July 30, 1987, C.B. was taking the lowest number of narcotics that she had taken since Respondent began treating her.
In January, 1988, Respondent terminated C.B.'s use of Demerol as she continued to improve, cooperate and participate in the psychotherapy. She was able to exercise and eat properly and had a better attitude.
C.B. had limited office visits with Respondent during 1988. When she returned for counseling in October of 1988, Respondent reviewed her medications. On October 7, 1988, Respondent recommended that C.B. attend individual counseling sessions with Anne Stowers, a psychologist, and group sessions with the Adult Children of Alcoholics group.
In November and December of 1988, Respondent attempted to stabilize
C.B. and control her use of Demerol for pain. He also prescribed Prozac for her but discontinued the prescription when C.B. seemed to become more depressed.
C.B. did not return to Respondent for treatment after December 21, 1988, because Respondent decreased her Xanax and refused to provide any further prescriptions for Demerol.
For almost three (3) years, Respondent treated C.B.'s chronic pain and mental condition with Darvocet, Tylox, Demerol, Xanax, Methadone, and Dolophine. During this time, C.B. functioned rather well for extended periods of time despite her severe psychopathology and headaches.
Respondent properly referred C.B. to counseling on several occasions. C.B.'s condition did not warrant a referral to an addictionologist or a psychiatrist. Even Petitioner's expert, Dr. Stein, acknowledged that there was no mandatory requirement for Respondent to refer C.B. for consultation. Respondent properly assessed C.B., correctly diagnosed her condition, and made the appropriate referrals.
Competent substantial evidence indicates that Respondent was sufficiently trained, experienced and qualified to treat C.B. The record also shows that Respondent provided C.B. with that level of care, skill and treatment which is recognized as acceptable under similar conditions and circumstances.
FINDINGS OF FACT AS TO PATIENT C.M.
Patient C.M., a manager of a fast-food restaurant, was born in 1957. She first presented to Respondent's group practice on June 17, 1987, complaining of muscular-skeletal tension headaches. C.M. suffered with a cluster of these headaches every six (6) to eight (8) months. She had not refilled her pain medication in nine months.
On her initial visit to Respondent's clinic, C.M. advised her treating physician that a local neurologist had done a complete neurological work-up, including a CT scan and spinal tap. The neurologist had prescribed Fiorinal and Valium for C.M.
C.M. returned to Respondent's clinic in March, 1988, after she was involved in a motorcycle accident. Injuries received in the accident curtailed C.M.'s participation in a jogging and exercise program which helped to relieve her chronic pain.
Respondent first saw C.M. on August 12, 1988, with a complaint of headaches. Respondent diagnosed C.M. with fibrositis syndrome and depression.
He prescribed Motrin, Flexiril and Imipramine and authorized refills of her prescriptions for Fiorinal and Valium.
C.M. received Demerol injections during her office visits from August to November of 1988. Respondent changed C.M.'s pain medication to Dolophine in December of 1988. C.M. reported that she was "doing a lot better," in February and April, 1989.
On June 28, 1989, C.M. was improving and her medication consumption was decreased. She was using Dolophine, Xanax and Fiorinal for pain at that time. Respondent counseled C.M. to continue the gradual reduction of pain medication.
In January, 1990, Respondent suggested that C.M. enter the hospital for a five (5) to seven (7) day period to terminate her medications and find alternative means of treatment for the headaches. C.M. declined to enter the hospital because her employment would not allow her any extended time off until later in March.
C.M. began to take her medications in anticipation of the pain, rather than waiting until there was actual pain. For the next four months, Respondent continued to recommend that C.M. seek hospitalization.
On April 20, 1990, C.M. informed Respondent that she was unable to enter the hospital because she lost her job and insurance benefits. Respondent began an intensive at-home treatment program to help relieve C.M. of her headaches without medications.
C.M. complied with the treatment program. She practiced the relaxation techniques and self-hypnosis that Respondent taught her. She kept a log of the number of pills she was taking so that she would be aware of the amount of medications she was using and could avoid addictive behavior.
C.M.'s condition improved. She began using less medications through the summer of 1990. She continued to follow Respondent's program to manage her pain until she went back to work in September of 1990.
On October 8, 1990, Respondent noted that C.M. was not recording her pill count. He was concerned that C.M. was "sliding back into some of her habits of anticipatory pain relief."
Respondent saw C.M. for the last time at the end of 1990. At that time, she was receiving Dolophine prescriptions for pain.
Respondent provided a comprehensive program of care for C.M. When C.M.'s condition improved, Respondent appropriately reduced her opioid medication. The use of opioids is a possible treatment for chronic pain.
During the course of treating C.M., Respondent prescribed various medication for C.M. including Fiorinal, Dolophine, Mepergan Fortis, Tylox, Xanax and Methadone. The prescriptions were appropriate given the ebb and flow of C.M.'s physical and mental state.
There was no need for Respondent to refer C.M. to an addictionologist. He treated her intractable pain using a level of skill and care similar to the most expert pain clinicians.
Petitioner did not charge Respondent with failure to refer C.M. to a psychologist.
The record does not indicate that a consultation with an addictionologist or psychiatrist would have made a difference in Respondent's treatment of C.M.
Respondent did not fail to give C.M. that level of care, skill and treatment which is recognized as being acceptable under the circumstances.
FINDINGS OF FACT AS TO PATIENT D.R.
Patient D.R., was born in 1958. She first presented to Respondent's group practice in 1987. D.R. had a history of a bleeding disorder and wanted one of Respondent's associates to follow her Coumadin treatment. The bleeding disorder was related to a rare condition, Klippel-Trenaunay Weber Syndrome, which is characterized by an abnormality of the bones and muscles in the extremities resulting in multiple deep vein thrombosis. An orthopedic physician in a separate practice followed her treatment for severe scoliosis. D.R. also suffered from secondary tension headaches and depression along with her multiple medical problems. She was in constant pain.
D.R.'s husband was in the Navy. From the beginning, Respondent's associate worked with a psychologist in an attempt to get the Navy Family Service Center to accept D.R. as a client for family and marital counseling.
In April, 1987, D.R. complained of tendonitis of the lower bicep region in the left arm. D.R.'s treating physician referred her to Respondent for consultation as to whether D.R. was suffering from a deep vein thrombosis. In May of 1987, D.R. was referred to a vascular surgeon.
In September of 1987, a surgeon at the Naval base performed a hysterectomy on D.R. because her anticoagulant therapy resulted in dysfunctional uterine bleeding.
In November of 1987 D.R. underwent orthopedic surgery to stablize her scoliosis.
Depending on D.R.'s complaint on each office visit, Respondent's associates prescribed Xanax, Valium, Tylox, Demerol, Darvocet, Vistaril, Motrin, Persantin, Phenergan, Flexoril, Septra, and Coumadin. D.R. continued to receive services from the group practice until March, 1988, when she requested that Respondent serve as her primary attending physician.
When Respondent began his care of D.R., she was already taking Vicodin two to three times per week, and Coumadin for hypercoagulaopathy.
In April, 1988, D.R. complained of increasing pain in her back and head. She had increased her use of Vicodin with no relief. Respondent switched her medications to 5 mg of Methadone every twelve (12) hours for pain. D.R. also received office injections of Demerol and Phenergan for immediate relief of her pain.
The Methadone seemed to work "very well" in relieving D.R.'s back pain. Respondent continued to prescribe this medication for the next several months.
For a period of time in June of 1988, Respondent terminated D.R.'s use of Amitriptyline. Other physicians had prescribed this drug for D.R. for four years and she was showing some side affects. Respondent changed D.R.'s medication to another antidepressant, Prozac, and the depression subsided.
Respondent prescribed several different medications, including Elavil, Motrin, Imipramine, Vistaril and Demerol, to relieve the patient's recurrent headache pain, through the summer of 1988. At one point, Respondent appropriately recognized the signs of dependency and refused to give D.R. a two month refill of Dolophine to take with her on an alleged two (2) month vacation. Toward the end of July, 1988, D.R. overdosed on Xanax and experienced hallucinatory feelings.
In August, 1988, Respondent discussed the increased use of medications with D.R. and referred her to a psychologist for counseling. Respondent also informed D.R. that she needed to enter an inpatient setting such as Charter-by- the-Sea. He also changed the time that D.R. could receive any medications to every other week to control her intake.
D.R. subsequently entered Charter-by-the-Sea for inpatient treatment. Upon her discharge, D.R. left Respondent's care to move to California. At the time she left, Respondent provided D.R. with a one (1) month supply of Demerol and Motrin for pain.
D.R. was already taking opioids when Respondent agreed to be her physician. He immediately began a program of controlling her intake of pain medication.
Although Respondent only treated D.R. for six (6) months, he made appropriate referrals to a psychologist and to an inpatient detoxification program. There was no need for Respondent to refer D.R. to an addictionologist until such time as she appeared intoxicated and hallucinating in July of 1988. At that point, Respondent properly hospitalized D.R., transferring her to the care of experts.
There is no persuasive record evidence that a referral to a psychiatrist was appropriate for D.R. Respondent made the appropriate assessment, diagnosis, and referrals for D.R. Additional consultations or referrals were not required. Respondent's treatment of D.R. met the level of care and skill which is recognized as acceptable under similar conditions and circumstances.
CHRONIC PAIN MANAGEMENT
Respondent did not use narcotics to treat the above referenced patients in an unorthodox, illegal, non-indicated, substandard manner.
Methadone is often used for detoxification purposes. However, it is also indicated for "relief of severe pain." Physicians may dispense Methadone from any licensed pharmacy for analgesic purposes.
C.A., C.B. C.M., and D.R. were suffering from chronic severe pain when Respondent began treating them. Therefore, Methadone was an appropriate part of their treatment program. There is no persuasive evidence that Respondent used Methadone with his patients for detoxification purposes.
Certain chronic pain patients respond satisfactorily to long-term opioid therapy, especially when no other treatment works for them. With the opioid treatment, these patients are able to function socially and participate in other modes of recommended treatment. Respondent's patients in this case fit this profile. They were in the one percent of the most difficult patients that one encounters. Additionally, these four patients represented only a fraction of a percent of Respondent's practice. There is no persuasive evidence that Respondent engaged in a pattern of improper chronic pain treatment.
Some physicians prefer to routinely use a multi-disciplinary approach to chronic pain treatment regardless of the severity and complexity of their patients' medical problems. They refer their chronic pain patients to neurologists, psychiatrists, psychologists, and occupational and physical therapists for extensive, expensive long-term care. However, a considerable percentage of patients treated under the multi-disciplinary approach still require long-term opioid treatment because it is the only way to keep the patient sufficiently functional to participate in the multi-disciplinary treatment.
All four of Respondent's patients improved for various periods of time while under Respondent's care. They were able to cope with serious episodes of pain and able to expand their function. Unfortunately, there was no cure for any of the conditions from which these four patients suffered.
Family physicians can manage such patients expertly if they: (a) are well informed about the use of opioids for analgesic purposes; (b) know their patients' medical history; (c) determine that the benefits of the treatment outweigh the risks; (d) establish a therapeutic relationship with the patient;
(d) develop a treatment plan, (e) prescribe the drugs in a prudent manner, and
(f) monitor their patients closely. Respondent met these criteria for each of the four patients discussed above.
Respondent accepted an provided comprehensive treatment for each of the four (4) patients for comprehensive treatment with the following understandings: (1) no other physician would prescribe opioids; (2) Respondent would determine the appropriate dosage; (3) the patient would keep appointments at regular intervals; and (4) the patient would seek consultations with other professionals when appropriate.
Throughout the treatment periods, Respondent appropriately considered whether the drugs were relieving his patients' pain and whether their level of function was improving.
Respondent's treatment plans were flexible enough to prevent damage if a patient became noncompliant. Without this flexibility, Respondent or the patient might have abruptly terminated the therapeutic relationship compounding the patient's problems.
Respondent closely monitored each patient to ensure that the treatment plan did not create addiction. He took appropriate corrective measures when a patient: (a) began to spend excessive time and energy to obtain the drug; (b) became intoxicated frequently; (c) gave up important social, occupational and recreational activities because of drug use and not because of chronic pain; (d) continued to use a drug even though the patient knew it caused or exacerbated psychological or physical problems.
In the 1980's, Respondent's referral and consultation resources were limited. Inpatient substance abuse programs were available but very expensive. The first outpatient addiction recovery programs focused on alcoholism. Pain treatment centers, mental health centers, and addictionologists became more available in the 1990's. Changes in insurance and state and federal pharmacological reporting requirements have also changed physicians' referral and consultation patterns in the last five years.
In the 1980's, Respondent's peers knew he was interested in chronic pain management. Because he was willing to treat patients with complex medical problems who were sometimes non-compliant, other local physicians routinely referred their difficult patients to Respondent.
Respondent's opioid prescriptions were all legal and within the allowable requirements relating to dosage and number prescribed. He controlled the amount of narcotics the patients received by writing prescriptions for low dosages and for short periods of time, sometimes even on a weekly rather than a monthly basis.
The evidence indicates that all four patients experienced severe long-term pain. These patients were incurable and did not respond to standard pain therapy or treatment. Respondent's care, treatment and careful monitoring provided these patients with pain relief sufficient for them to function in society and carry on with their lives. Referral to or consultations with psychiatrists and addictionologists were not required.
Respondent's care and skill in managing his patient's chronic pain met the professional standard of care of a family practitioner in the state of Florida.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the parties and subject matter of this proceeding, pursuant to Section 120.57(1), Florida Statutes, and Section 455.225, Florida Statutes.
Pursuant to Section 458.331(2), Florida Statutes, the Board of Medicine is empowered to revoke, suspend or otherwise discipline the license to practice medicine of any physician found guilty of the acts enumerated in Section 458.331(1), Florida Statutes.
In a license disciplinary proceeding of this nature, the Petitioner bears the burden of proving its charges by clear and convincing evidence. Ferris v. Turlington, 510 So. 2d 292 (Fla. 1987). Petitioner has not met its burden in the instant case.
Dr. Masters appropriately assessed, diagnosed and provided treatment to all four patients "with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances." Section 458.331(1)(t), Florida Statutes.
Neither of Petitioner's witnesses provided any persuasive testimony challenging Respondent's care and treatment of the four patients based on his knowledge, training, experience, and expertise as a family practitioner.
Petitioner failed to provide clear and convincing evidence of a violation of the Medical Practices Act as alleged in the Administrative Complaint.
CONCLUSION
Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a Final Order finding that Respondent did not violate Section 458.331 (1)(t), Florida Statutes, and dismissing the Administrative Complaint.
RECOMMENDED in Tallahassee, Leon County, Florida, this 30th day of October, 1995.
SUZANNE F. HOOD, Hearing Officer 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 30th day of October, 1995.
APPENDIX
The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the proposed findings of facts submitted by the parties to this case.
Petitioner's Proposed Findings of Facts:
1-2 Accepted in Findings of Fact 2-3 of this Recommended Order.
3-11 Accepted in Findings of Fact 9-17 of this Recommended Order.
Accepted in Findings of Fact 7 of this Recommended Order.
Accept that Respondent's expert, Mitchell B. Max, M.D., is a physician licensed to practice in the state of Maryland. Dr. Max is board certified in internal medicine, neurology, and clinical pharmacology. Reject that his total work experience has been in pain management and medical research.
Accepted in Findings of Fact 18 and 34 of this Recommended Order. 15-16 Accepted in Findings of Fact 35 of this Recommended Order.
Accepted in Findings of Fact 21 of this Recommended Order.
Rejected as not supported by competent persuasive evidence.
Accepted in part in Findings of Fact 39 of this Recommended Order; however, reject that C.A.'s condition failed to improve at any time during the approximately five (5) year treatment period.
Accepted as modified in Findings of Fact 46 of this Recommended Order.
Rejected as not supported by competent persuasive evidence.
Accepted as modified in Findings of Fact 46 of this Recommended Order.
Accepted as modified in Findings of Fact 47 of this Recommended Order.
Rejected as not supported by competent persuasive evidence.
Accepted as modified in Findings of Fact 59 of this Recommended Order.
Rejected as not supported by competent persuasive evidence. See Finding of Fact 58 of this Recommended Order.
Rejected as not supported by competent persuasive evidence.
Accepted in Findings of Fact 62 of this Recommended Order.
Accepted in Findings of Fact 65 of this Recommended Order.
Accepted in Findings of Fact 76 of this Recommended Order.
32-33 Rejected as not supported by competent persuasive evidence.
34 Accepted as modified in Findings of Fact 68-70 of this Recommended Order.
35-36 Rejected as not supported by competent persuasive evidence.
37-39 Accepted as modified in Findings of Fact 81 of this Recommended Order.
Accepted as modified in Findings of Fact 88, 90-91, and 93 of this Recommended Order.
Testimony indicating that D.R.'s condition failed to improve is rejected as not supported by competent persuasive evidence. Accept that Respondent never referred D.R. for a psychiatric consultation; however, such a referral was not required.
Accepted as modified in Findings of Fact 88 of this Recommended Order.
Rejected as not supported by competent persuasive evidence.
Accepted as modified in Findings of Fact 92-95 of this Recommended Order.
Rejected as not supported by competent persuasive evidence.
Respondent's Proposed Findings of Facts:
1-4 Accepted in Findings of Fact 1-6 of this Recommended Order.
5-13 Legal argument regarding the admissibility of expert testimony.
Rulings made on the record during the hearing or in the Preliminary Statement. 14-38 Accepted in substance as modified in Findings of Fact 18-45 of this
Recommended Order.
39-56 Accepted in substance as modified in Findings of Fact 46-61 of this Recommended Order.
57-73 Accepted in substance as modified in Findings of Fact 62-80 of this Recommended Order.
74-87 Accepted in substance as modified in Findings of Fact 81-94 of this Recommended Order.
88-108 Accepted in substance as modified in Findings of Fact 97-112 of this Recommended Order.
COPIES FURNISHED:
Albert Peacock, Esquire Agency for Health Care
Administration
1940 North Monroe Street Suite 60
Tallahassee, FL 32399-0792
Alex D. Barker, Esquire Elaine Lucas, Esquire Donald W. Weidner, P.A.
10161 Centurion Parkway North Suite 190
Jacksonville, FL 32256
Dr. Marm Harris, Executive Director Agency for Health Care
Administration Board of Medicine
1940 North Monroe Street Tallahassee, FL 32399-0792
Lynda L. Goodgame, Esquire Agency for Health Care
Administration
1940 North Monroe Street Tallahassee, FL 32399-0792
NOTICE OF RIGHT TO SUBMIT EXCEPTIONS
All parties have the right to submit written exceptions to this Recommended Order. All agencies allow each party at least 10 days in which to submit written exceptions. Some agencies allow a larger period within which to submit written exceptions. You should contact the agency that will issue the final order in this case concerning agency rules on the deadline for filing exceptions to this Recommended Order. Any exceptions to this Recommended Order should be filed with the agency that will issue the final order in this case.
| Issue Date | Proceedings |
|---|---|
| Dec. 29, 1995 | Final Order filed. |
| Nov. 27, 1995 | (Donald W. Weirder) Notice of Substitution of Co-Counsel w/cover letter filed. |
| Oct. 30, 1995 | Recommended Order sent out. CASE CLOSED. Hearing held July 11, 12, and 18, 1995. |
| Sep. 11, 1995 | Disk (from Alex Barker/tagged) filed. |
| Sep. 07, 1995 | Letter to SFH from Alex Baker (RE: enclosing disk of proposed recommended order/Ho has disk) filed. |
| Sep. 01, 1995 | Letter to HO from Elaine Lucas Re: Pages 15, 19, 22 and 25 of Respondent's Proposed Recommended Order (w/pages attached) filed. |
| Aug. 31, 1995 | Petitioner's Proposed Recommended Order filed. |
| Aug. 31, 1995 | Respondent's Proposed Recommended Order filed. |
| Aug. 08, 1995 | Order Granting Unopposed Motion sent out. (motion granted, PRO's shall be due by 8/31/95) |
| Aug. 08, 1995 | (Petitioner) Motion for Extension of Time for Filing Proposed Recommended Orders filed. |
| Aug. 04, 1995 | Transcript of Proceedings Volume III filed. |
| Aug. 03, 1995 | Volume I; Volume II (Transcript) filed. |
| Jul. 28, 1995 | Letter to Maureen Willis from Elaine Lucas (cc: HO) Re: Petitioner's Exhibit 2 filed. |
| Jul. 18, 1995 | CASE STATUS: Hearing Held. |
| Jul. 18, 1995 | CASE STATUS: Hearing Held. |
| Jul. 14, 1995 | Notice of Video Hearing sent out. (Video Hearing set for 7/18/95; 9:00am) |
| Jul. 11, 1995 | CASE STATUS: Hearing Partially Held, continued to 7/18/95; 9:00am; Ax. |
| Jun. 28, 1995 | (Petitioner) Prehearing Stipulation filed. |
| Jun. 27, 1995 | Petitioner's Motion to Take Official Recognition filed. |
| May 31, 1995 | (Petitioner) Notice of Serving Petitioner's First Set of Request for Admissions, Interrogatories, and Request for Production of Documents; Petitioner's First Set of Request for Admissions, Interrogatories, andRequest for Productio n of Documents to Respon |
| Jan. 31, 1995 | Petitioner`s Notice of Filing Responses to Respondent`s Initial Set of General Interrogatories and First Request for Production; Petitioner`s Response to Respondent`s First Request for Production; Petitioner`s Response to Respondent First Set of Interro |
| Jan. 25, 1995 | Second Order Granting Continuance and Rescheduling Hearing sent out.(hearing rescheduled for July 11-12, 1995; 10:00am; Ax) |
| Jan. 17, 1995 | Respondent's Motion to Reschedule Hearing filed. |
| Jan. 04, 1995 | (Respondent) Notice of Appearance of Co-counsel; Notice of Serving Respondent's First Set of Request for Production of Documents and Interrogatories to Petitioner filed. |
| Aug. 08, 1994 | Order Granting Continuance and Rescheduling Hearing sent out. (hearing rescheduled for February 23 and 24, 1994; 10:30am; Jacksonville) |
| Jul. 25, 1994 | Petitioner's Motion to Reschedule Hearing filed. |
| Jul. 01, 1994 | Notice of Hearing sent out. (hearing set for December 15 and 16, 1994; 10:00am; Jacksonville) |
| Jul. 01, 1994 | Order of Prehearing Instructions sent out. |
| Jun. 13, 1994 | Joint Response to Initial Order filed. |
| Jun. 02, 1994 | Initial Order issued. |
| Issue Date | Document | Summary |
|---|---|---|
| Dec. 22, 1995 | Agency Final Order | |
| Oct. 30, 1995 | Recommended Order | Physician not guilty of failing to refer patients with chronic pain to a psychiatrist or an addictionologist. |
DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs ISRAEL RABINSKY, M.D., 94-002941 (1994)
AGENCY FOR HEALTH CARE ADMINISTRATION vs ROBERT J. MEEK, D.O., 94-002941 (1994)
DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs PHILIP K. SPRINGER, M.D., 94-002941 (1994)
DEPARTMENT OF HEALTH vs MICHAEL C. BENGALA, M.D., 94-002941 (1994)
