The Issue At issue herein is whether or not the Respondent has engaged in conduct violative of Section 459.14(2)(a), Florida Statutes. 1/
Findings Of Fact Based upon the testimony adduced at the hearing and the entire record compiled herein, the following relevant facts are found. Pursuant to an Administrative Complaint filed herein dated July 8, 1978, the Florida State Board of Osteopathic Medical Examiners, herein sometimes referred to as the Board, seeks to discipline the Respondent/Licensee, Albert Jack Berg, based upon an Order of Summary Suspension entered against Respondent's Michigan Osteopathic license on February 16, 1977. The basis for the summary suspension in Michigan was a charge that Respondent had engaged in the unlawful sale and delivery of a controlled substance. Respondent was noticed of a hearing which was convened on May 9, 1978, to consider the allegations of the alleged unlawful delivery of the controlled substance. On July 10, 1978, a Final Order of Revocation was entered by the Board of Osteopathic Medicine and Surgery of Michigan, revoking Respondent's license to practice osteopathic medicine and surgery in Michigan. 2/ Respondent did not contest, at the hearing, the material allegations of the Administrative Complaint, but rather, offered mitigating evidence. In this regard, the evidence reveals that the Respondent has been licensed in Michigan since approximately July of 1961 and has been licensed in Florida since approximately 1972 (License No. 3460). In relating the circumstances surrounding his arrest in Michigan in February of 1977, Respondent avers that he was under tremendous emotional strain due to a divorce and that resultant pressures brought about from being a father of four children whose wife threatened suicide and being left with the task of rearing children alone. He related that he was undergoing parental pressure to remarry his wife and that he carried an excessive overload in his office practice. Respondent delivered several thousand Amphetamine tablets to an undercover agent in Michigan. The Amphetamine tablets had been in Respondent's possession for more than seven years and a laboratory analysis revealed that they contained ten percent (10 percent) of the Amphetamine content found in a commercially sold Amphetamine tablet. For his conviction in the State of Michigan, Respondent was initially sentenced for a period of two years, which sentence was later reduced to six months in jail, and he was thereafter released during the day hours to serve in a community guidance center under the supervision of a Dr. Richard M. Brown of Michigan. As evidence by the letter of recommendation from Doctor Brown, Respondent worked in ghetto areas of Detroit, Michigan, treating in excess of one hundred patients on a weekly basis for a period of approximately five months. Respondent has been under the care of a psychiatrist since approximately August of 1977, where he has been placed on a high protein diet with a reduced work load. Respondent presently attends "How To Control Your Life" seminars and is presently doing "pro bono publico" work for agricultural referral centers. Respondent purchased a degree from a school in Louisiana that issued medical doctor (M.D.) degrees to persons such as himself. He was motivated to purchase the degree based on instructions from a publisher who was interested in contracting to publish a book that Respondent was then writing. Respondent wrote a letter to the American Cancer Society withdrawing the "M.D." designation from his title. (Respondent's Exhibit 1.) If allowed to continue practice in Florida, Respondent intends to maintain a "ghetto" practice in order to provide medical services to the disadvantaged and those unable to pay the usual fee for such services. Respondent related that he did what sick physicians normally do; that is, turn to (1) drugs, (2) alcohol or (3) suicide. Respondent referred to an article published by the American Medical Association entitled, "The Sick Physician", dated February 5, 1973. (Respondent's Exhibit 2.) An examination of the pre-sentence memoranda submitted by Respondent to the Michigan authorities reveals that he has accounted for the mistakes and problems that he encountered in the State of Michigan during early 1977 and based on such memoranda, it is obvious that he recognized that a mistake was made and curative efforts have been taken (by Respondent) to rehabilitate himself. (Respondent's Composite Exhibit 3.)
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED: That the Respondent be placed on probation in the State of Florida for a period of two (2) years. During the above two-year period of probation, it is RECOMMENDED that the Respondent be directed to engage only in the performance of medical services in a community service organization, with semi-monthly reporting requirements in a manner prescribed by the Board to its agents. RECOMMENDED this 21st day of July, 1980, in Tallahassee, Florida. JAMES E. BRADWELL, Hearing Officer Division of Administrative Hearings 101 Collins Building Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 21st day of July, 1980.
The Issue At issue is whether Alexander Boudreau, a minor, qualifies for coverage under the Florida Birth-Related Neurological Injury Compensation Plan (Plan).
Findings Of Fact Stipulated facts Vacelia Koumendouros and Steven Boudreau, are the natural parents and guardians of Alexander Boudreau, a minor. Alexander was born a live infant on November 29, 1999, at Morton Plant Hospital, a hospital located in Clearwater, Florida, and his birth weight exceeded 2,500 grams. Obstetrical services were delivered at Alexander's birth by Ivelisse D. Ruiz-Robles, M.D., who, at all times material hereto, was a "participating physician" in the Florida Birth-Related Neurological Injury Compensation Plan, as defined by Section 766.302(7), Florida Statutes. Coverage under the Plan Permanent to this case, coverage is afforded by the Plan for infants who suffer a "birth-related neurological injury," defined as an "injury to the brain . . . caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate postdelivery period in a hospital, which renders the infant permanently and substantially mentally and physically impaired."2 § 766.302(2), Fla. Stat. See also §§ 766.309 and 766.31, Fla. Stat. Here, indisputably, Alexander is permanently and substantially physically impaired. What remains to resolve is whether the record supports the conclusion that, more likely than not, Alexander is also permanently and substantially mentally impaired, and whether Alexander's neurologic impairments resulted from an "injury to the brain . . . caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate postdelivery period," as required for coverage under the Plan. Mrs. Koumendouros' prenatal care Mrs. Koumendouros received her prenatal care at the Diagnostic Clinic, Clearwater, Florida, a group practice comprised of four physicians, including Dr. Ruiz-Robles. According to the records of the Diagnostic Clinic, on November 22, 1999, with an estimated delivery date of December 8, 1999, and the fetus at 37 5/7 weeks' gestation, Mrs. Koumendouros' obstetrician recommended delivery by cesarean section, given a breech presentation, polyhydramnios (an excess of amniotic fluid), risk of cord prolapse with rupture of the membranes if dilated, and risk of infection. Mrs. Koumendouros and her husband agreed, and delivery was scheduled for noon, November 29, 1999. Alexander's birth and immediate postnatal course The medical records related to Alexander's birth reveal that at or about 9:45 a.m., November 29, 1999, Mrs. Koumendouros was admitted to Morton Plant Hospital, for an elective cesarean section. Notably, Mrs. Koumendouros was not in labor, when admitted or at any time thereafter, and monitoring revealed a reassuring fetal heart rate, with a baseline in the 140-beat per minute range, accelerations over time, no decelerations, and good fetal movement.3 With regard to Alexander's delivery, the medical records reveal that Mrs. Koumendouros was in the operating room at 12:25 p.m., surgery started at 12:50 p.m., and Alexander was delivered at 1:02 p.m., with Apgars of 6, 9, and 9 at one, five, and ten minutes, respectively. Accordingly to Dr. Ruiz-Robles' Operative Report, Alexander was "easily delivered," without incident. The Apgar scores assigned to Alexander are a numerical expression of the condition of a newborn, and reflect the sum points gained on assessment of heart rate, respiratory effort, muscle tone, reflex irritation, and skin color, with each category being assigned a score ranging from the lowest score of 0 to a maximum score of 2. As noted, at one minute, Alexander's Apgar score totaled 6, with heart rate and reflex irritation being graded at 2 each, respiratory effort and muscle tone being graded at 1 each, and skin color being graded at 0. At five minutes and ten minutes, Alexander's Apgar score totaled 9, with heart rate, respiratory effort, muscle tone, and reflex irritation being graded at 2 each, and skin color being graded at 1. According to the Delivery Record, Alexander was initially cyanotic, and became apneic. However, he responded rapidly to tactile stimulation, suctioning, and whiffs of oxygen, and by three minutes, Alexander's respiratory effort was noted as regular, by five minutes, his Apgar scores were normal, and, by 1:20 p.m., he was transferred to the holding nursery. Following admission to the holding nursery, newborn admission assessment noted an alert, active infant, with normal cry, normal perfusion, and breath sounds equal bilaterally. However, assessment also noted "increased work of breathing for a short period," as well as hypotonia, acrocyanosis, large head (macrocephaly), skin tag on the right breast, small eyes, low set ears, distended abdomen, and abnormal foreskin. Given Alexander's presentation, neonatal consultations were requested, and Alexander was evaluated at 2:25 p.m., and 3:15 p.m. As for the 2:25 p.m., consultation, little information is of record; however, the 3:15 p.m., consultation noted that Mrs. Koumendouros' pregnancy was significant for Level II ultrasounds revealing microcephaly and hydrocephalus, which seemed to be resolving, and for polyhydramnios/large abdomen. History also included the not normal findings noted on admission to the holding nursery, discussed supra. The consultant's assessment/plan included, the following: Term male - c-section Macrocephaly - needs CT, neurology evaluation. So will xfer to [A]ll C[hildrens] H[ospital]. TORCH eval. Genetic evaluation [Increased] ab. size - abd x-ray prior to feeding. Mom had polyhydramnios, [history] 5 - 10 cc suctioned from abdomen [after] delivery. GU evaluation of penis . . . . At 3:30 p.m., Alexander was transferred to the Neonatal Intensive Care Unit (NICU) for further management, and at 6:00 p.m., he was transferred to All Children's Hospital, where he remained until his discharge on December 20, 1999. Alexander's care at All Children's Hospital was documented in his Discharge Summary, as follows: DISCHARGE DIAGNOSES Term Male Infant Hypotonia Neonatal Seizures Pensoscrotal Web Central, Mixed and Obstructive Apnea Hypotonia and Collapse of Posterior Pharynx Macrocephaly Splenic Cyst Jaundice Skin Tag Micro-ophthalmia OPERATIONS AND PROCEDURES CT Scan of the Brain Echocardiogram Cranial Ultrasound Abdominal Ultrasound Karyotype FISH for Prader-Willi Syndrome Phototherapy Laryngoscopy Total Parenteral Nutrition Sleep Study CONSULTS Social Work Services Genetics Urology Neurology Neurosurgery Otolaryngology Developmental Evaluation and Intervention Program HISTORY: Baby Boy Koumendouros was born by a C-section delivery with Breech presentation to a 34 year old G1PO mother. The C-section was for Breech presentation. Apgars were 6, 9, and 9. Birth weight was 3336 gm and estimated gestational age was [3]8 weeks. The mother had a urinary tract infection and pyelonephritis during this pregnancy. There was also Breech presentation and polyhydramnios. A Level II ultrasound showed microcephaly and hydrocephalus, with the most recent ultrasound showing some resolution but beginning polyhydramnios and a large abdomen. The mother took the following medications during this pregnancy: prenatal vitamins and Macrobid. Delivery room resuscitation included stimulation, suctioning, and whiffs of oxygen. Care at the referring hospital included stabilization in the delivery room. The infant was made NPO and was placed on IV fluids when microcephaly was noted. The infant was transferred to All Children's Hospital for further management of microcephaly and rule out hydrocephalus. RESPIRATORY/APNEA: The infant was admitted to All Children's Hospital on room air. On day #4 of life, the infant required nasal cannula oxygen that continued until 11 days of life. The infant had a sleep study done [December 9, 1999] which showed a significant amount of obstructive and hypopneas throughout the study. The infant had increased work of breathing. He also had an elevated end tidal CO2 that climbed to as high as 60's during the study. The infant had some central apneas in addition to the obstructive apnea. The interpretation is that this is an abnormal study, given the frequency of obstructive apneas as well as the increased work of breathing. The infant was seen by Otolaryngology and had laryngoscopy performed which showed hyponia and collapse of the posterior pharynx. The infant will require follow-up with the Otolaryngology Service one month post-discharge. The infant is being discharged on a home apnea monitor and on a car bed. CARDIOVASCULAR: An echocardiogram was performed due to a murmur and multiple congenital abnormalities on day #1 of life, which showed a small patent ductus arteriosus, a dilated patent foramen ovale versus an atrial septal defect. The infant no longer has a murmur. However, he will need to be followed by Cardiology in 6 months with a echocardiogram due to the presence of a patent foramen ovale versus atrial septal defect. BILIRUBIN: The infant developed jaundice . . . . This was treated with 1 day of phototherapy . . . . INFECTIONS: Maternal Group B Strep status was unknown. Blood and CSF cultures were obtained on admission to All Children's Hospital. The infant was started on ampicillin and gentamicin. All cultures were negative and antibiotics were stopped after 6 days. * * * METABOLIC: Due to the infant's neurological status, serum amino acids and urine organic acids were obtained. The serum amino acids show ornithine appeared mildly elevated in otherwise normal pattern. This mild elevation alone may be due to diet and does not suggest a well recognized aminoacidopathy. The urine organic acids appeared to be within expected limits and no abnormalities were noted. CENTRAL NERVOUS SYSTEM: Due to microcephaly, the infant had a CT scan performed on day #1 of life which showed prominent extra axial fluid with mild prominence of the ventricles. A repeat CT scan done at 14 day of life shows a stable appearance of the ventricular system and brain parenchyma. There was mild prominence of the ventricles and extra axial fluid persists. There is some question about the integrity of the corpus callosum. A MRI was recommended at 8 weeks life. The infant developed seizures on day #1 of life. An EEG showed significant attenuation of the background rhythms without eliptiform discharges of subclinical seizures. The infant was started on Phenobarbital prior to the EEG being obtained. A repeat EEG was obtained at 14 days of life and was within normal limits. The infant was weaned off of Phenobarbital prior to discharge. The infant will require follow-up with Neurology as well as the Developmental Evaluation and Intervention Program after discharge. GENETIC PROBLEMS/DYSMORPHOLOGY: The infant had the following dysmorphic features noted on admission: Low set ears, abdominal distention, hepatomegaly, penoscrotal web, hypotonia, webbed neck, and skin tag on right nipple. Chromosomes showed 46XY. the infant also had FISH and uniparental disomy testing for Prader-Willi, which both are negative. The infant was seen by Genetics, and the plan is for a follow-up in 2 months. * * * OPHTHALMOLOGY: The infant was seen by Dr. Hess due to the presence of micro- ophthalmia, and recommendations are for follow-up in 6 months. * * * PHYSICAL EXAM AT DISCHARGE: The infant continues to be hypotonic but is more alert then he had previously been. FOLLOW UP: Pediatrician, Drs. Hassell and Pham on 12/21/99 at 3 p.m. DEI Program on 1/31/00 at 2:40 p.m. Neurology on 1/10/00 at 4:15 p.m. OT/PT Genetics in 2 months. Dr. Hess on 6/26/00 at 10 a.m. Otolaryngology on 1/19/00 at 11:00 a.m. Cardiology on 3/2/00 at 10 a.m. Echocardiogram on 3/2/00 at 9 a.m. Urology on 2/22/00 at 11:15 a.m. Use a carbed to transport infant, as instructed CPR and monitor training for home monitor use * * * MONITOR INFORMATION: The infant is being discharged on a monitor. The parents have been instructed by All Children's Hospital in CPR and by the monitor company in monitor utilization. The monitor is being provided by Pediatric Health Choice. Regulation of the monitor will be through the pediatrician. Alexander's subsequent development Alexander's history and early development was documented on a Pasco County School Social Work Report, dated December 7, 2001 (Respondent's Exhibit 1), as reported by Mrs. Koumendouros (Boudreau), as follows: Mrs. Boudreau described her pregnancy with Alex as being relatively normal, with the exception of the condition of polyhydraminos or excessive amniotic fluid. This was monitored throughout the pregnancy, though the danger to the fetus was thought to be minimal. A sonogram revealed that Alex had a larger head than normal. Mrs. Boudreau was tested twice for possible diabetes, but both tests were negative. In the 8th month, she was determined to have a low risk for complications. Alex was delivered near his due date by cesarean section due to breech presentation. His birth weight was 7 pounds, 6 ounces and he was determined to be healthy, though a neonatologist was called in after the birth due to the baby's head size being larger than normal. Alex was transferred to All Children's Hospital for tests and observation for a possible seizure disorder. He was given Phenobaritol for the length of his 21-day hospital stay, which was reduced and then discontinued upon discharge to home. He was provided with an apnea monitor, which was used for 2 months without incident. At two months of age, Alex did not exhibit adequate head control and he was referred to the Early Intervention Program for a developmental screening. No treatment was prescribed until Alex's follow up at 6 months of age, when he began receiving occupational and physical therapy to address his low muscle tone. At one year of age, Alex was found to have visual acuity problems and a possible nystagmus. He received a prescription for glasses. He can detect and respond to people or objects that are approximately 6 feet from his eyes. His ophthalmologist is Dr. J. Bruce Hess. In December of 2000, Alex was examined by neurologist Dr. Rao, who subsequently ordered an MRI of the brain. The MRI revealed an "atrophy of the brain" and "hemorrhage of the motor area." It was at this time that Alex was diagnosed with cerebral palsy, which [was] described to the parents as a "catch-all" term for a broad range of disabilities involving, but not necessarily limited to motor functioning.[4] A genetic screening revealed no identified syndrome or genetic condition. The Boudreaus are hopeful that Alex's delays are primarily physical in nature and that he will show evidence of more normal intellect, though this has not been confirmed by therapy and evaluation reports at this point. Alex has continued to receive occupational and physical therapy twice weekly in addition to home based visual therapy and additional visual therapies from Lighthouse for the Blind. Mrs. Boudreau states that Alex has some form of therapy for 11 hours each week. Alex is able to support his head and is working on the development of trunk support. He is not ambulatory, but is starting to work with a gait trainer. Alex is not able to grasp objects successfully, but can self- feed larger pieces of food and is working with a specially designed spoon. He can pull at his bib or his diaper. Verbal skills include babbling and short cries for attention. Mrs. Boudreau has noted that Alex uses different vocal tones for different purposes and will attempt to "sing" along with music that he likes. For stimulation, Alex has a "little box" at home, which is designed for him to lay down in, facing up, with visual images and hanging objects for grasping. Mrs. Boudreau notes that Alex is more animated and verbal after spending time in the "little box." Alex also has a Rifton chair and a vertical stander in the home . . . . Currently, insofar as the record demonstrates, Alexander presents with a diagnosis of hypoxic cerebral palsy, severe visual impairment, and severe delay in receptive and expressive language development. There is also evidence that Alexander suffers cognitive delay. However, the proof does not address the significance of Alexander's cognitive or mental delay. The cause and timing of Alexander's neurologic impairments To address whether Alexander's neurologic impairments were related to an "injury to the brain . . . caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate postdelivery period," as required for coverage under the Plan, Petitioners, Valecia Koumendouros and Steven Boudreau, testified on their own behalf, and offered a photograph of Alexander, taken April 2005 (Petitioners' Exhibit 1). Additionally, Respondent offered the medical records relating to Mrs. Koumendouros' antepartum course, as well as those associated with Alexander's birth and subsequent development, and the expert testimony of Dr. Donald Willis, a physician board-certified in obstetrics and gynecology, as well as maternal-fetal medicine. (Respondent's Exhibits 1 and 2.) Respondent also offered an affidavit and report of Dr. Michael Duchowny, a pediatric neurologist; however, Dr. Duchowny's affidavit was hearsay, and could not support a factual finding in this proceeding. (Respondent's Exhibit 3.) § 120.57(1)(c), Fla. Stat. As for the etiology of Alexander's impairments, Dr. Willis' voiced no opinion. However, based on his review of the medical records, Dr. Willis was confident that, whatever the etiology, Alexander's impairments were not related to an injury to the brain caused by oxygen deprivation or mechanical injury during the birthing process or the immediate postdelivery period. In so concluding, Dr. Willis noted: Q. After reviewing the records, what is your opinion concerning whether there was an injury to Alexander's brain or spinal cord caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate post-delivery period? A. I did not find any apparent births- related obstetrical event that could have led to or resulted in a loss of oxygen or mechanical injury to the child's brain. Q. Would you please explain the basis for your opinion? A. Yes, I would. First, let me say that the mother was not in labor at time of the Cesarean section, so it was an elective Cesarean section for polyhydramnios, too much amniotic fluid, and breech presentation. So the -- * * * MS. STOREY: Okay. THE WITNESS: Okay. Well, the medical records state that the elective Cesarean section was done for polyhydramnios and breech presentation. I reviewed the fetal heart rate monitor strip that was available prior to delivery, after admission to the hospital. There were some irregular uterine contractions. The fetal heart rate that was available for observation did not show any distress. The mother's cervix was closed and long at time of admission suggesting that there was no active labor at the time. At the time of the elective Cesarean section, the operative note described the delivery as being -- the infant was easily delivered from the breech presentation. So I did not have anything to suggest a trauma at the time of the actual birth. And then in the immediate post-delivery period, the baby's one-minute apgar was low at six: and the baby did require some oxygen, which they described as whiffs, for about five minutes. But the baby improved; and by five minutes, the apgar score was nine, which could be a normal apgar score. So based on that, it was my impression that there was no active labor, that there was no incident during the actual delivery of the baby that would have led to oxygen deprivation or a mechanical trauma to the brain; and the same would be said for the immediate post-delivery period. The opinions of Dr. Willis are consistent with the medical records (which speak to the likelihood of a developmental disorder, as opposed to birth trauma, as the likely cause of Alexander's difficulties), uncontroverted, and credible.5 In contrast to the proof offered by Respondent, Petitioners offered no expert medical testimony regarding the likely etiology of Alexander's impairments. Consequently, it must be resolved the proof fails to support the conclusion that Alexander's impairments were most likely caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate postdelivery period. See, e.g., Wausau Insurance Company v. Tillman, 765 So. 2d 123, 124 (Fla. 1st DCA 2000)("Because of the medical conditions which the claimant alleged had resulted from the workplace incident were not readily observable, he was obliged to present expert medical evidence establishing that causal connection."); Ackley v. General Parcel Service, 646 So. 2d 242 (Fla. 1st DCA 1995)(determining cause of psychiatric illness is essentially a medical question, requiring expert medical evidence); Thomas v. Salvation Army, 562 So. 2d 746, 749 (Fla. 1st DCA 1990)("In evaluating medical evidence, a judge of compensation claims may not reject uncontroverted medical testimony without a reasonable explanation.").
The Issue The issue in the case is whether the allegations in the Administrative Complaints are correct and, if so, what penalty should be imposed.
Findings Of Fact At all times material to this case, the Respondent was a licensed physician in the State of Florida, holding license number ME0039986. DOAH Case Number 01-3795PL Between May 22 and June 5, 1998, the Respondent ordered a series of diagnostic lab tests for Patient C. H., a 63-year- old female. As to the care provided to Patient C. H., the Petitioner presented the testimony of Hamilton Fish, M.D., whose testimony was persuasive and is credited. According to Dr. Fish, many of the tests performed on Patient C. H. were not medically indicated according to a review of the information set forth in the patient's medical records, and the medical treatment care provided by the Respondent to the patient was inappropriate and failed to meet the applicable standard of care. According to the hemoglobin test performed on Patient C. H., the patient was diabetic and the diabetes was uncontrolled. The Respondent did not provide proper treatment to the patient for the diabetes. According to one of the lab tests, Patient C. H. was deficient in calcium. The Respondent did not provide appropriate treatment for the calcium deficiency. Although there was no medical indication that Patient C. H. had a thyroid problem, the Respondent prescribed a thyroid hormone medication. The thyroid medication was inappropriate and could have exacerbated the diabetic condition. DOAH Case Number 01-3796PL The Petitioner introduced into evidence an advertisement that appears to have been published in the June 25, 1999, edition of the "Sun-Sentinel Community News." There is no evidence that the Respondent created, read, placed, or paid for the advertisement in the newspaper. The ad offered a complementary consultation with the Respondent, who was identified in the ad as a diplomate of the "American Board of Anti-Aging." Florida law requires that a disclaimer appear in such advertisements advising a patient of the right to essentially decline non-free services that are recommended on the basis of the free consultation. The cited advertisement did not include the disclaimer. The Petitioner's administrative rules prohibit advertisement of affiliation with groups not "recognized" by the Petitioner. The Petitioner has not approved of the "American Board of Anti-Aging." DOAH Case Number 01-3797PL Patient D. E. On or about July 21, 1998, the Respondent ordered a series of diagnostic lab tests for Patient D. E., a 53-year-old male. According to the records, Patient D. E. had complained of impotency and loss of sexual desire. As to the care provided to Patient D. E., the Petitioner presented the testimony of Timothy Shapiro, M.D., whose testimony was persuasive and is credited. According to Dr. Shapiro, many of the tests performed on Patient D. E. were not medically indicated according to a review of the information set forth in the patient's medical records. At least one of the tests performed on several of the patients referenced herein (the "Barnes Basil Temperature Test") is not recognized in the medical community as providing valid information for the conventional diagnosis or treatment of any disorder. On or about August 18, 1998, the Respondent diagnosed Patient D. E. with hypothyroidism, panhypothyroidism, food allergies, and impotence of organic origin. He prescribed Cytomel, Armour Thyroid, and testosterone gel for the patient. According to the testimony of Dr. Shapiro, the prescribed medications were inappropriate because the medical record fails to indicate any deficiencies being addressed by the medication. The course of treatment provided for the patient is not documented by the medical records and is below the standard of care. Patient J. N. On or about August 27, 1998, the Respondent ordered a series of diagnostic lab tests for Patient J. N., a 50-year-old female. According to the records, Patient J. N.'s symptoms included fatigue, numbness, tingling and burning in the extremities, muscle and head aches, insomnia, swelling, depression and easy bruising. As to the care provided to Patient J. N., the Petitioner presented the testimony of Hamilton Fish, M.D., whose testimony was persuasive and is credited. According to Dr. Fish, many of the tests performed on Patient J. N. were not medically indicated according to a review of the information set forth in the patient's medical records. On or about September 10, 1998, the Respondent diagnosed Patient J. N. with chronic fatigue, probable hypothyroidism, and unspecified liver disorder. An existing diagnosis of ischemic heart disease was confirmed; he prescribed various medications for the patient. According to the testimony of Dr. Fish, the prescribed drugs (Cytomel, Hydrocortisone, Rezulin, and a female hormonal transdermal gel) were inappropriate and below the standard of care, and the medical records do not justify the course of treatment provided by the Respondent. Patient T. B. On or about October 8, 1998, the Respondent ordered a series of diagnostic lab tests for Patient T. B. (also identified as T. P.) a 49-year-old female. According to the records, Patient T. B.'s symptoms included muscle ache, migraines, insomnia, vaginal discharge, and neck, back and stomach pain. As to the care provided to Patient T. B., the Petitioner presented the testimony of Hamilton Fish, M.D., whose testimony was persuasive and is credited. According to Dr. Fish, many of the tests performed on Patient T. B. were not medically indicated according to a review of the information set forth in the patient's medical records, and the medical treatment care provided by the Respondent to the patient was inappropriate and failed to meet the applicable standard of care. On or about October 21, 1998, the Respondent diagnosed Patient T. B. with hyperthyroidism, migraine headaches, chronic fatigue, yeast infection, and unspecified disorder of the intestines, stomach, and duodenum. He prescribed various medications for the patient. According to the testimony of Dr. Fish, the prescribed drugs (Cytomel and Armour Thyroid) were inappropriate and below the standard of care, and the medical records do not justify the course of treatment provided by the Respondent. The Respondent failed to perform a pelvic examination or to refer the patient to a gynecologist despite the diagnosis that she was suffering a yeast infection, and therefore failed to meet the applicable standard of care. The diagnosis of unspecified disorder of the stomach, duodenum, and intestines was apparently based on described pain. There is nothing in the medical record indicating that appropriate testing to determine causality was ordered or performed. Patient A. M. On or about August 26, 1998, the Respondent ordered a series of diagnostic lab tests for Patient A. M. According to the records, Patient A. M.'s symptoms included muscle and head ache, constipation, cramps and menstrual irregularity, decreased libido, sore throat and sinus problems. As to the care provided to Patient A. M., the Petitioner presented the testimony of Hamilton Fish, M.D., whose testimony was persuasive and is credited. According to Dr. Fish, many of the tests performed on Patient A. M. were not medically indicated according to a review of the information set forth in the patient's medical records, and the medical treatment care provided by the Respondent to the patient was inappropriate and failed to meet the applicable standard of care. On or about September 9, 1998, the Respondent diagnosed Patient T. B. with hypothyroidism, chronic fatigue, hyperinsulinemia, and unspecified ovarian dysfunction. The lab test results do not support the diagnosis. On December 2, 1998, the Respondent prescribed various medications for the patient. According to the testimony of Dr. Fish, the prescribed drugs (Cytomel, Rezulin, Glucophage, glycine, and fish oil) were inappropriate for the patient and below the standard of care, and the medical records do not justify the course of treatment provided by the Respondent.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Agency for Health Care Administration, Board of Medicine, enter a final order suspending the medical license of Robert M. Knight, M.D., for a period of one year followed by five-year period of probation, and imposing an administrative fine of $5,000. DONE AND ENTERED this 19th day of April, 2002, in Tallahassee, Leon County, Florida. ___________________________________ WILLIAM F. QUATTLEBAUM Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 19th day of April, 2002. COPIES FURNISHED: Kathryn E. Price, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Robert M. Knight, M.D. 5650 Camino del Sol, Number 101 Boca Raton, Florida 33433 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Mr. R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
Findings Of Fact At all times material, Respondent, Michael J. Warhola, D.O. (Warhola), was licensed as an osteopathic physician, license number 05 0001256, issued by the State of Florida. At all times material, Warhola was in general practice in Tampa, Florida. A large part of Respondent's practice consisted of patients wishing to lose or control weight. PATIENT CURTIS HANCOCK Between on or about September 25, 1984 and on or about June 10, 1985, Respondent treated patient Curtis Hancock for weight control primarily. On the first visit, a patient history was obtained from Hancock. The patient history was adequate for a weight control patient such as Hancock except that it did not include a detailed record as to the length of time Hancock has experienced the weight problem, what diet medications Hancock had taken, what kind of weight loss program Hancock had been involved in and the history of recent weight loss or gain and diet. On Hancock's first visit, Warhola also had Hancock's blood pressure, weight and pulse taken. Additionally, Hancock's age and height were recorded. Respondent did not listen to (auscultate) Hancock's heart sounds but did, and reviewed, an electrocardiogram. These physical examinations and other testing performed on Hancock on the first visit were inadequate for a patient such as Hancock only in that Warhola did not examine and palpate Hancock's neck (for thyroid abnormalities). One of the tests Warhola had performed on Hancock on September 25, 1984, was a SMAC 26 comprehensive blood test which includes T3, T4 and T7 studies. Those test results and the rest of the examination revealed no abnormalities in Hancock's thyroid function or metabolic function. On or about the first office visit, Respondent provided Hancock with literature about diet. The literature contained a recommendation that the patient abstain from alcohol and sugar intake. But Respondent did not attempt to treat Hancock by diet and exercise alone first. Respondent generally makes the presumption that by the time a patient comes to him for weight control the patient has tried an assortment of diet regimens, possibly supplemented by exercise and over-the-counter diet medications. He presumes that what the patient wants and needs in order to accomplish weight loss or weight control is prescription diet drugs. On the first visit on September 25, 1984, Warhola prescribed and dispensed to Hancock the following drugs: DRUG QUANTITY Multi Vitamin 28 Phentermine 8 mg. 56 Phendimetrazine 35 mg. 56 Promethazine HCL 12.5 mg. 28 On each subsequent office visit Warhola had his office staff take Hancock's blood pressure, weight and pulse rate. At no time during his treatment of Hancock did Respondent listen to Hancock's heart sounds. No additional electrocardiograms of Hancock were taken after the initial visit. Respondent performed no other physical examination of Hancock on any of the subsequent office visits. Between October 23, 1984 and June 10, 1985, Respondent prescribed and dispensed for Hancock the following drugs: DATE MEDICATION QUANTITY 10/23/84 Multi Vitamin 28 Thyroid 1 gr. 28 Ferrous Gluconate 28 Phentermine 30 mg. 112 Phendimetrazine 35 mg. 112 Prcmetharine HCL 12.5 mg. 28 11/20/84 Multi Vitamin 28 Thyroid 1 gr. 28 Ferrous Gluconate 28 Phentermine 30 mg. 112 Phendimetrazine 35 mg. 112 Phentermine 8 mg. 112 Promethazine HCL 12.5 mg. 28 12/11/84 Thyroid 1 gr. 28 Ferrcus Gluconate 28 Phentermine 30 mg. 112 Phendimetrazine 35 mg. 112 Promethazine HCL 12.5 Bran Fiber mg. 28 01/24/85 Multi Vitamin 28 Levo Thyroid 0.1 mg. 28 Ferrcus Gluconate 28 Phentermine 30 mg. 112 Phendimetrazine 35 mg. 112 Promethazine HCL 12.5 mg. 28 Fastamine 112 02/01/85 Multi Vitamin 28 Levo Thyroid 0.1 mg. 28 Ferrous Gluconate 28 Phentermine 30 mg. 112 Phendimetrazine 35 mg. 112 Promethazine HCL 12.5 mg. 28 Fastamine 112 Vistaril 50 mg. 28 03/14/85 Multi Vitamin 56 Levo Thyroid 0.1 mg. 56 Ferrous Gluconate 56 Phentermine 30 mg. 224 Phendimetrazine 35 mg. 224 Promethazine HCL 12.5 mg. 56 Vistaril 50 mg. 56 Hyosophen - 224 (Belladonna Alkaloids w/ Phenobarbital) Hydrochlorothiazide 50 mg. 56 w/Reserpine 0.25 mg. 04/30/85 Multi Vitamin 56 Levo Thyroid 0.1 mg. 56 Ferrous Gluconate 56 Phentermine 30 mg. 224 Phendimetrazine 35 mg. 224 Promethazine HCL 12.5 mg. 56 Vistaril 50 mg. 56 Hyosophen 224 (Belladonna Alkaloids w/ Phenobarbital) Hydrochlorothiazide 50 mg. 56 w/ Reserpine 0.25 mg. 06/10/85 Multi Vitamin 56 Levo Thyroid 0.1 mg. 56 Ferrous Gluconate 56 Phentermine 30 mg. 224 Phendimetrazine 35 mg. 224 Promethazine HCL 12.5 mg. 56 Vistaril 50 mg. 56 Hyosophen 224 (Belladonna Alkaloids w/ Phenobarbital) Hydrochlorothiazide 50 mg. 56 w/ Reserpine 0.25 mg. The labels for the drugs identified in the immediately preceding paragraph did not contain the name of the drugs dispensed. Hancock did not ask, and Respondent did not verbally advise Hancock of, the names of the drugs which Respondent dispensed or caused to be dispensed to Hancock. Phentermine 8 mg. and 30 mg. and phendimetrazine 35 mg. are sympathomimetic amines. Phendimetrazine is a schedule III controlled substance, under Section 893.03, Florida Statutes. Phentermine is a schedule IV controlled substance, under Section 893.03, Florida Statutes. Tolerance to the anorectic affects of both of these drugs usually develops within a few weeks. When this occurs, the recommended dose usually should not be exceeded in an attempt to increase the effect; rather, the drugs should be discontinued. One of the notable contra-indications of both of these drugs is elevated blood pressure (moderate and severe hypertension, any diastolic value of 100 or higher). Manifestations of chronic intoxication with anorectic drugs (like phentermine and phendimetrazine) include marked insomnia, irritability, hyperactivity and personality changes. Promethazine HCL is a sleep medication. Thyroid and Levo Thyroid are both thyroid medications which are indicated for use where hypothyroidism exists. Both drugs are metabolic stimulants given to compensate for decreased thyroid function. If either of these medications is administered to an individual who had a normal thyroid function or euthyroidism, the drugs would cause the individual to experience hyperthyroidism, or an increased metabolic condition, and the possibility of serious side effects. Fastamine is the brand name for a drug containing benzocaine and is used to curb appetite by numbing the stomach. Vistaril is a depressant which can function as an anti-anxiety agent. Hydrochlorothiazide 50 mg. is a diuretic which was dispensed by Respondent in a compound form which also contained Reserpine 0.25 mg. Reserpine is a drug that will cause an initial stimulation, like epinephrine, followed by a secondary effect of depression. Hydrocholorthiazide 50 mg. with reserpine 0.25 mg. is used as a diuretic and an anti-hypertensive agent. It is generally accepted that thyroid medications, such as Thyroid, Levo Thyroid and a drug named Cytomel (which is similar in action to the other thyroid medications), should not be prescribed, dispensed, or ordered with sympathomimetic amines. The combination of thyroid medications and sympathomimetic amines, when dispensed or prescribed to be taken together, can be very dangerous and can potentially result in cardiovascular shock. Unless caused by hypothyroidism, obesity is not an acceptable indication for thyroid hormone therapy. A review of Respondent's records for patient Hancock reveals that between September 25 and December 11, 1984, Hancock lost 12 1/2 pounds. Between January 24 and February 1, 1985, Hancock gained 4 1/2 pounds. Between February 1 and April 30, 1985, Hancock lost 11 1/2 pounds. Between April 30 and June 10, 1985, Hancock gained 6 1/2 pounds. Respondent's records reflect Hancock's starting weight was 213 1/2 pounds. On the date of Hancock's last visit, almost ten months after the patient's first visit, Hancock weighed 200 1/2 pounds with a total weight loss of only 13 pounds. A review of Respondent's records for patient Hancock reveals that Hancock's blood pressure was 120/84 on September 25, 1984; 120/84 on October 23, 1984; 122/80 on November 20, 1984; 120/84 on December 11, 1984; 130/90 on January 24, 1985; 140/100 on February 21, 1985; 150/100 on March 14, 1985; 144/90 on April 30, 1985; and 130/80 on June 10', 1985. In an otherwise healthy adult, any diastolic (the second of the two numbers in a blood pressure reading) value of 90 or greater for an extended period of time is considered mild hypertension. A diastolic value of 100 or greater is considered serious hypertension. Despite the fact that the diastolic value of Hancock's blood pressure readings was 90 or higher between January 24, 1985 and April 30, 1985, Respondent did not reduce or eliminate the number of sympathomimetic amines and thyroid medications dispensed to patient Hancock. Respondent responded to the elevated blood pressure readings found in Hancock by adding an anti-hypertensive agent to the existing regimen of drugs. He hypothesized that the elevated blood pressure was a result of marital problems Hancock told him he was having. On March 14, 1985, April 30, 1985, and June 10, 1985, Respondent dispensed what was supposed to be a two months supply of the above-listed drugs. On April 30, 1985, Hancock returned for more medications after 46 days; and on June 10, 1985, Hancock returned for medications after only 40 days. Nonetheless, Respondent dispensed more medications on each occasion. Respondent's records indicate that on April 30, 1985, a two month supply was dispensed because the Respondent was going on vacation. Respondent told Ms. Gazverde during the course of an interview that if a patient returned earlier than scheduled, refills would be refused until the scheduled visit or proof of loss of medication was provided. But, if this was Respondent's policy, it was not followed in Hancock's case. Respondent inappropriately and excessively dispensed phentermine, phendimetrazine and thyroid medications, including Thyroid and Levo Thyroid, to patient Hancock in that: The phentermine and phendimetrazine were prescribed and dispensed in excessive dosages and for an excessive length of time; The phentermine and phendimetrazine were prescribed and dispensed in combination (and in excessive dosages); Thyroid medications were prescribed although Hancock's thyroid was normal; Thyroid medications were prescribed to be taken in combination with the phentermine and phendimetrazine; Respondent continued to prescribe phentermine, phendimetrozi and thyroid medications to Hancock despite moderate to severe hypertension (140/100 on 2/21/85 and 150/100 on 3/14/85); Respondent twice dispensed more drugs than he had prescribed for Hancock without requiring Hancock to account for the missing drugs; and Respondent made no effort to treat Hancock without drugs as first line of treatment. Respondent failed to practice osteopathic medicine with acceptable levels of care, skill and treatment for the reasons listed in paragraph 23, above, and because Respondent did not examine or palpate Hancock's neck for thyroid abnormalities on any visit and neither did an electrocardiogram nor listened to Hancock's heart sounds on follow-up visits. In addition to the matters set out in the two immediately preceding paragraphs, Respondent's records for patient Hancock were not adequate to justify Respondent's treatment of Hancock in that no information was recorded as to the length of time the patient had experienced a weight problem; what diet medications Hancock had taken; what kind of weight loss program Hancock had been involved in; and a history of recent weight loss or gain and diet. A reasonably prudent osteopathic physician, in obtaining a patient history for weight control purposes, would question the patient as to their normal weight, determine past techniques utilized for weight control (including medication, diet and exercise), and ascertain recent weight history and length of time the weight problem has existed. The information should be in the patient record. Additionally, a reasonably prudent physician, in examining a patient for weight control purposes, would perform a physical examination including, at a minimum, examination and palpation of the neck and auscultation of the heart. Alternatively, an electrocardiogram serves the purpose of auscultation of the heart. Respondent did not examine or palpate patient Hancock's neck. Furthermore, Respondent did not listen to patient Hancock's heart sounds. Respondent did and reviewed an electrocardiogram on Hancock's first visit but not on his follow-up visits. PATIENT HOPE ECHEZABAL Between on or about November 3, 1971 and April 21, 1984, Warhola intermittently treated patient Hope Echezabal for weight control. On Echezabal's first visit, Warhola took an adequate patient history of Echezabal except, like Hancock, the patient history does not record detailed information as to the length of time the patient had experienced a weight problem, what diet medications Echezabal had taken, what kind of weight loss program Echezabal had been involved in, or a history of recent weight loss or gain and diet. The patient history indicated normal menstruation. On Echezabal's first visit to Respondent's office, Respondent performed an inadequate physical examination only in that no pulse rate was taken and Warhola did not examine or palpate the patient's neck. Respondent also did not listen to Echezabal's heart sounds, but Warhola did have an electrocardiogram done on Echezabal. The testing did include testing with an achilleometer, an obsolete thyroid test. All of the testing and physical examination of Echezabal revealed no thyroid or metabolic abnormalities. Like Hancock after her, Echezabal was given diet literature, including a booklet called "Lo-Carbo Diet," and was advised to avoid starches, sugar, and alcoholic beverages. Respondent also discussed Echezabal's diet and eating habits. Echezabal returned to Respondent's office on December 3, 1971, January 12, 1972 and April 7, 1972. As was his practice on follow-up visits, Warhola had his office staff weigh Echezabal and take her blood pressure. Although no additional electrocardiogram was performed, Warhola did not take Echezabal's pulse rate or listen to her heart sounds. In fact, he did no further physical examination of Echezabal at all. He just discussed diet and whether Echezabal was following her diet. After a hiatus of two years, Echezabal went back to Respondent on or about August 20, 1973. In accordance with his practice, Warhola treated Echezabal as he would a new patient since she had not been to his office for over a year. Warhola had Echezabal update her patient history in the same manner in which he did her original patient history. His physical examination and testing also was the same as on the initial visit in 1971. Once again, the examination and testing revealed no thyroid or metabolic abnormalities. Warhola also discussed with the patient her diet and eating habits. Echezabal returned to Respondent's office on November 16, 1973. On this follow-up visit, Warhola had his office staff take Echezabal's blood pressure and weigh her. Otherwise, Warhola did not physically examine Echezabal. Her pulse rate was not taken, there was no additional electrocardiogram, and Respondent did not listen to her heart. Warhola did, however, again discuss Echezabal's diet and eating habits. It is clear from Echezabal's testimony that Respondent's treatment of her before May, 1979, included the use of medications. Echezabal did not ask, and was never advised either verbally or by labeling, of the names of the drugs which were dispensed to her by Respondent. As with all his patients, Respondent documented the drugs dispensed to Echezabal by utilizing medication codes instead of the common name for the drugs. The medication codes were then recorded in the patient charts. Because the medication codes have changed over the years, the identities of the drugs dispensed to Echezabal before May, 1979, are unknown. Echezabal did not return to Respondent's office again until May 29, 1979. Because it had been about 5 1/2 years since Echezabal's last visit, Respondent treated her as a new patient, requiring the same updates to her patient history and having the same examinations and tests performed, including an electrocardiogram. Testing indicated that Echezabal was marginally anemic, and Respondent prescribed and dispensed iron tablets only and told her to return for a follow-up visit. Otherwise, the examination and testing revealed no abnormalities. Echezabal returned for a follow-up visit on June 11, 1979. On that date, Warhola had his office staff take Echezabal's blood pressure and weigh her. Additionally, office staff obtained a hemoglobin and hematocrit count on Echezabal and drew blood for analysis at an outside laboratory. Warhola did not take Echezabal's pulse rate or do another electrocardiogram or listen to her heart sounds. Warhola did no other physical examination of Respondent on June 11, 1979, but only discussed diet and eating habits. On or about June 11, 1979, Respondent dispensed to Echezabal 28 ferrous sulfate 5 gr. tablets, 28 Thyroid 2 gr. tablets, 112 phendimetrazine 35 mg. tablets, 28 Benadryl 50 mg. tablets, and 28 multi vitamin/mineral tablets, with instructions to begin taking the pills on the next day. When Respondent dispensed the above-mentioned drugs on June 11, 1979, Respondent did not have the results of tests which were to be performed by an outside laboratory on blood drawn by office staff. (Respondent had ordered a SMA 15 profile, which includes testing for glucose levels, and a thyroid study done on the blood specimen.) However, Respondent would have contacted patient Echezabal when the results came back the next day if he thought the results contra-indicated any of the medications. On or about June 12, 1979, Respondent received the results of a thyroid study and SMA 15 profile at Patterson Coleman Laboratories. The tests revealed no metabolic abnormalities. The test did reveal a slight abnormality in the T3 value, which was "34". The T3 value measures thyroid uptake and was only marginally below normal limits. In determining whether there is abnormal thyroid function, the "T3" value is only one factor to be considered. In view of the fact that the two other pertinent values, the thyroxine, or T4 value, and the "FTI" value were within normal limits, Echezabal could not properly have been diagnosed as suffering from abnormal thyroid function. Furthermore, it would be inappropriate to prescribe thyroid medication, given the results of the thyroid study done in June 1979. Respondent's records for Echezabal do not document any history of an abnormal thyroid function or any history involving thyroid medications taken by Echezabal prior to 1971. Despite the fact that patient Echezabal revealed no conclusive evidence of an abnormal thyroid function, Respondent failed to discontinue the thyroid medication which he ordered for Echezabal on June 11, 1979. On or about August 2, 1983, Echezabal returned to Respondent's office and was, again, treated like a new patient. Accordingly, Echezabal was asked to update her patient history. Additionally, office staff took Echezabal's blood pressure and pulse, and weighed Echezabal. This was the first occasion on which Echezabal's pulse rate was taken. On August 2, 1983, office staff obtained a hemoglobin and hematocrit count, performed a urinalysis and performed an electrocardiogram on Echezabal. Additionally, office staff drew blood for analysis by an outside laboratory. Finally, Warhola again discussed diet and eating habits with Echezabal. On or about August 2, 1983, Respondent dispensed or caused office staff to dispense to Hope Echezabal Cytomel 50 mg. (which is a thyroid medication similar to Thyroid and Levo Thyroid discussed above), phendimetrazine 35 mg., ferrous sulfate 5 gr. (iron), and Benadryl 50 mg., an antihistamine. Again, Respondent dispensed these medications without waiting for the results of SMA 26 profile which was to be performed on the blood specimen drawn by office staff at outside laboratories. On or about August 3, 1983, Respondent received the results of the SMA 26 which was performed at Central Medical Laboratory, Inc., which included an analysis of thyroid function. The tests revealed completely normal thyroid function. Despite evidence of normal thyroid function, Respondent failed to discontinue the Cytomel 50 mg. which he had prescribed for Echezabal. On or about September 8, 1983, Echezabal returned to Respondent's office. On that date, office staff took Echezabal's blood pressure and pulse. Additionally, office staff weighed Echezabal. Finally, as was his practice, Respondent spoke to Echezabal about her diet and eating habits. Respondent failed to conduct any kind of examination of Echezabal on September 8, 1983. Nor did Warhola do another electrocardiogram. On or about September 8, 1983, Respondent caused office staff to dispense 28 Cytomel 50 mg. tablets, 112 phendimetrazine 35 mg. tablets, 28 Benadryl 50 mg. tablets and 28 multi vitamin/mineral tablets to patient Echezabal. At the time Respondent caused these medications to be dispensed, his records reflected normal thyroid function in Echezabal. On or about April 21, 1984, Echezabal again came to Respondent's office for weight control purposes. On that date, office staff obtained an update in patient history, and obtained the patient's blood pressure, pulse, and weight. Also on that date, office staff obtained hematocrit and hemoglobin levels for the patient, a two hour post prandial blood sugar, and a urinalysis. Echezabal's blood pressure was 130/90 on April 21, 1984. Respondent spoke with Echezabal about her diet and eating habits. Respondent did not examine patient Echezabal at all on April 21, 1984. Nor did Warhola do another electrocardiogram. On or about April 21, 1984, Respondent caused office staff to dispense 28 Hydroreserpine .25 mg. tablets, 28 Levo Thyroid .1 mg. tablets, 56 phentermine 30 mg. tablets, 28 Benadryl 50 mg. tablets, and 28 multi vitamin/mineral tablets to Echezabal with instructions to start taking the pills the next day. At the time Respondent dispensed the above-mentioned drugs, his own records for patient Echezabal revealed normal thyroid function. Hydroreserpine is the brand name for a compound containing a diuretic and reserpine (which has previously been described above). Hydroreserpine is typically given as an anit-hypertensive agent. On or about April 22, 1984, Echezabal began to take the medications dispensed by Respondent on April 21, 1984, in the manner directed by Respondent. Accordingly, Echezabal would have taken 4 tablets by noon on that date. Echezabal should have taken by 10:00 a.m., on April 22, 1984, a green Hydroreserpine .25 mg. tablet (probably before breakfast), a yellow phentermine 30 mg. tablet (probably before breakfast), a yellow Levo Thyroid .1 mg. tablet (probably at 10:00 a.m.) and a white phentermine 30 mg. tablet (at 10:00 am.). After taking her 10:00 a.m. medication, Echezabal experienced a reaction to the medication. Specifically, Echezabal vomited and was hyperventilating. Echezabal rested for a period of time and was later transported to University Community Hospital in Tampa, Florida, by ambulance, where she was treated for a drug overdose. At no time during his treatment of patient Echezabal did Echezabal ask, or did Respondent advise Echezabal of, the names of the drugs which were dispensed by his office staff to Echezabal. Furthermore, the labeling for the substances dispensed to Echezabal did not contain the name of the medications dispensed. When Echezabal arrived at University Community Hospital, neither Echezabal nor her husband, Henry, who drove her to the hospital, knew what drugs Mrs. Echezabal had taken on the morning of April 22, 1984. At the time of admission at University Community Hospital, blood and urine specimens were taken from Echezabal for analysis. A comprehensive drug profile showed no alcohol. A second test performed on gastric blood serum revealed ethanol in the blood serum in the amount of 0.016 GM percent. The amount would be relatively negligible. Respondent inappropriately dispensed medications to patient Echezabal in that: Thyroid medications were prescribed although Echezabal's thyroid was normal; Sympathomimetic amine was prescribed to be taken in combination with thyroid medication; Phentermine was prescribed on April 21, 1984, in excess of maximum dosages; and Respondent made no effort to treat Echezabal without drugs as a first line of treatment (especially when she lost a pound between May 28 and June 11, 1979, without any medication prescription.) Respondent failed to practice osteopathic medicine with acceptable levels of care, skill and treatment for the reasons listed in paragraph 55, above, and because Respondent did not examine or palpate Echezabal's neck for thyroid abnormalities on any visit, neither did an electrocardiogram nor listened to her heart sounds on follow-up visits or on April 21, 1984, and did not take her pulse on some visits. In addition to the matters set out in paragraphs 55 and 56, above, Respondent's records for patient Echezabal were not adequate to justify Respondent's treatment in that: The records do not detail weight control programs the patient had tried, diet medications taken or recent history of weight loss or gain and diet; The records do not justify starting Echezabal at relatively high dosages of phendimetrazine on June 11, 1979 and August 2, 1983; The records do not justify the Benadryl prescriptions; and; The records do not state whether the patient was on a diet or explain why she lost a pound between May 28 and June 11, 1979, without any medication prescription. PATIENT BETH HELLE Between on or about November 8, 1971, and on or about May 4, 1984, Respondent intermittently treated Beth Helle for weight control. On Helle's first visit, Warhola required a patient history which was adequate except it but did not detail the length of time the patient had experienced a weight problem, what diet medications she had taken, what kind of weight loss program she had been involved in or a history of the recent weight loss or gain and diet. It indicated a normal menstrual history. Warhola also performed an inadequate physical examination only in that Warhola did not take Helle's pulse or examine or palpate her neck for thyroid abnormality. He did not listen to her heart sounds, but he took Helle's cardiogram. Warhola also discussed diet with Helle. He told her what foods she could eat and gave her a book dealing with carbohydrate counts in different foods designed to assist the patient in limiting carbohydrate intake. The examination and testing of Helle on November 8, 1971, which included testing with an achilleometer, did not reveal any abnormal thyroid or metabolic function. Helle's patient history revealed hypertension in 1970, but that condition probably related to a pregnancy and miscarriage at that time. On or about November 8, 1971, Respondent caused office staff to dispense medications to Helle. Helle never asked, and Respondent never told Helle, what the medication were. The labels on medication dispensed to Helle (like Echezabal) did not contain the common name of the drug dispensed. In Respondent's records, the medication names are indicated in a code, which has since changed. The names of the medications dispensed by Respondent to Helle before 1984 are unknown. On or about May 12, 1975, Helle returned to Respondent's office for treatment. Since 3 1/2 years had passed, Helle was treated as a new patient. Helle's patient history was updated in the same manner as the original patient history. Again Warhola inadequately examined Helle only in that Helle's pulse rate was not taken, and Respondent did not examine and palpate Helle's neck. Warhola did not listen to her heart sounds, but he did perform an electrocardiogram of Helle among the tests he performed. Again, the examination and tests, which included testing with an achilleometer, revealed no abnormal thyroid or metabolic function. In addition to the examination and testing on May 12, 1975, Warhola again discussed diet with Helle. He had his office staff dispense medications to Helle. Helle did not ask, and Respondent did not verbally advise Helle of, the names of the drugs dispensed. Again, the labels were in code, and identities of the drugs are not now known. On or about June 16, 1975, Helle returned to Respondent's office. On this follow-up visit, Warhola had his office staff take and record Helle's blood pressure and weight. Her pulse was not taken, and no electrocardiogram was made. Warhola did not physically examine Helle and specifically did not listen to her heart sounds or examine or palpate her neck. Warhola again discussed eating habits and diet with Helle and had his office staff dispense medications. Again, Helle did not ask, and was not told, what the medications were, and the medication labeling did not reflect the drug name. The code on the label has been changed, and the identities of the drugs are not now known. Helle returned for another follow-up visit on October 30, 1975. Again, Warhola had his office staff take and record Helle's blood pressure and weight. Her pulse rate was not taken, and no electrocardiogram was made. Warhola did no physical examination and specifically did not listen to Helle's heart sounds or examine or palpate her neck. Respondent again discussed diet and eating habits with Helle. Helle did not return to Warhola's office for treatment until May 4, 1984. Since eight and 1/2 years had elapsed since her last visit, Helle was treated as a new patient the same type of update of her patient history was taken. Warhola also had his office staff take and record Helle's blood pressure, pulse and weight. Blood specimens for analysis at an outside laboratory also were drawn. Warhola did not listen to Helle's heart sounds but did make and review an electrocardiogram. He did not examine or palpate her neck. Finally, Respondent talked with Helle about her diet and eating habits, specifically advising her to avoid fatty foods. On or about May 4, 1984, Respondent caused office staff to dispense 28 trichloromethiazide 4-mg. tablets, 28 Levo Thyroid .1 mg. tablets, 112 phendimetrazine 35 mg. tablets, 112 phentermine 8 mg. tablets, 28 branfiber tablets, and 28 Benadryl 50 mg. tablets. Respondent dispensed these medications without waiting for the analysis by the outside laboratory of blood drawn from Helle on that date. Trichloromethiazide is an oral diuretic and anti- hypertensive agent. On or about May 5, 1984, Respondent received the results of a SMA 26 profile run on the blood specimen obtained from Helle on May 4, 1984. The laboratory results revealed normal thyroid function, normal glucose levels and normal metabolic function. On or about May 8, 1984, Respondent received the results of a TSH profile run on May 4, 1984. The test again revealed normal thyroid function. Respondent's records for patient Helle do not reveal any documentation of a history of abnormal thyroid function even though Helle testified at the formal hearing that she had experienced abnormal thyroid function previously. Proper documentation would include a description of the abnormality (hypothyroidism or hyperthyroidism); a statement as to how long the condition existed; and a description of how the condition was treated. This last factor would be most significant in this case because Respondent dispensed Levo Thyroid although Helle testified that she had previous reactions to another thyroid medication (Cytomel). Respondent's records contain no documentation of any abnormal thyroid function during Respondent's treatment of the patient. None of the medications dispensed by Respondent's office staff on May 4, 1984, were labeled in a manner which would identify the common name of the drug. Respondent inappropriately and excessively prescribed phentermine, phendimetrazine and Levo Thyroid to patient Helle, in that: The phentermine and phendimetrazine were prescribed and dispensed in excessive dosages; The phentermine and phendimetrazine were prescribed and dispensed on May 4, 1984, in combination (and in excessive dosages); Thyroid medication was prescribed on May 4, 1984, although Helle's thyroid was normal, according to information known to Warhola at that time; Thyroid medication was prescribed to be taken in combination with phentermine and phendime- trazine; and Respondent made no effort to treat Helle without drugs as a first line of treatment. Respondent failed to practice osteopathic medicine with acceptable levels of care, skill and treatment for the reasons listed in paragraph 72, above, and because Respondent did not examine or palpate Helle's neck for thyroid abnormalities on any visit, neither did an electrocardiogram nor listened to her heart sounds on two follow-up visits, and did not take her pulse on the first four of her five visits. In addition to the matters set out in paragraphs 72 and 73, above, Respondent's records for patient Helle were not adequate to justify Respondent's treatment in that: The records do not detail weight control programs the patient had tried, diet medications taken or recent history of weight gain or loss and diet; The records do not justify starting Helle at high dosages of phentimetrazine (much less in combination with the other drugs) on May 4, 1984; The records do not justify the Benadryl prescription; and the records do not detail what "swelling always" and "some fluid retention" notations mean, including the part of the body affected, the results of examination and Respondent's diagnosis.
Recommendation Based on the foregoing Findings Of Fact and Conclusions Of Law, it is recommended that the Board of Osteopathic Medical Examiners enter a final order holding Respondent, Michael J. Warhola, D.O., guilty of violating Sections 459.015(n),(q) and (t), Florida Statutes (1985), and suspending his license to practice osteopathic medicine for six months. RECOMMENDED this 4th day of March, 1987 in Tallahassee, Florida. J. LAWRENCE JOHNSTON 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 4th day of March, 1987.
Other Judicial Opinions A party who is adversely affected by this final order is entitled to judicial review pursuant to Sections 120.68 and 766.311, Florida Statutes. Review proceedings are governed by the Florida Rules of Appellate Procedure. Such proceedings are commenced by filing the original of a notice of appeal with the Agency Clerk of the Division of Administrative Hearings and a copy, accompanied by filing fees prescribed by law, with the appropriate District Court of Appeal. See Section 766.311, Florida Statutes, and Florida Birth-Related Neurological Injury Compensation Association v. Carreras, 598 So. 2d 299 (Fla. ist DCA 1992). The notice of appeal must be filed within 30 days of rendition of the order to be reviewed.
The Issue The issues are whether Respondent violated Section 458.331(1)(t), Florida Statutes, and if so, what penalty should be imposed.
Findings Of Fact Petitioner is the state agency that regulates the practice of medicine and licenses medical doctors pursuant to Chapter 458, Florida Statutes. Respondent is a licensed physician, holding license number ME 0034692. S.S. has one child who was born in 1987. S.S. delivered the child vaginally after a term pregnancy (40 weeks) and 16 hours of labor. In January 1991, S.S. had cyrosurgery of the cervix as a result of an abnormal pap smear. Cyrosurgery is a procedure in which a metal probe is placed against the cervix. The metal probe is then super-cooled with liquid carbon dioxide to freeze and destroy cells on the cervix. Cyrosurgery causes severe scarring of the cervix to the point that it may interfere with the natural process of labor. S.S. was a new patient of H. Wyatt McNeill, M.D. on April 24, 1991. At that time, S.S. was 22 years old. She was five feet and nine inches tall and weighed almost 147 pounds. In February 1992, Dr. McNeill inserted Norplant in the subcutaneous tissue of S.S.'s arm. Norplant is a contraceptive that consists of six cylinders. The cylinders release a drug that interferes with the development of pregnancy. It has various side effects that include irregular bleeding patterns. Norplant users may have regular periods, irregular periods, or no periods at all. Norplant has the same failure rate as the "pill." On October 1, 1992, S.S. had an appointment with Dr. McNeill. She was complaining of lower abdominal pain. She had not had a period since the Norplant was inserted. Dr. McNeill prescribed Anaprox DS for probable uterine cramps. On June 1, 1994, S.S. saw Dr. McNeill again. She was still using Norplant. Her periods were regular and predictable at that time. Dr. McNeill saw S.S. for an annual gynecological examination on March 13, 1995. Her weight had increased to 163 pounds. S.S. informed Dr. McNeill that she had intermittent mild lower-left quadrant abdominal pain, which may have been related to her menstrual cycle. S.S. still had the Norplant in place and was having monthly periods. S.S.'s next appointment with Dr. McNeill was on October 30, 1995. She again complained of lower abdominal pain. She also reported a positive home pregnancy test. A pregnancy test performed in Dr. McNeill's office also was positive. A positive pregnancy test does not indicate a live fetus. If the placenta is still functioning, it can take 60 days or more after the delivery of a dead fetus to clear the placental hormone out of the blood system. S.S. told Dr. McNeill that she had a history of irregular bleeding until the three prior months. Her visual appearance did not indicate that she was pregnant. In other words, she was not "showing" as one would expect in a pregnancy of 30 weeks or more. S.S. did not report that she had felt any fetal movement or quickening. "Quickening" is the first feeling of fluttering within the uterus that is normally felt between 18-20 weeks of pregnancy. Dr. McNeill then performed a bimanual pelvic examination and noted in his chart that S.S.'s uterus felt 12 weeks in size. The fundus of the uterus was halfway between the umbilicus and the symphysis pubis, indicating that S.S. was approximately 12 weeks pregnant. If the fundus had been level with the umbilicus, it would have evidenced a pregnancy of 20 weeks or five months. Next, Dr. McNeill performed a brief transvaginal sonogram (TVS) or ultrasound scan, saw some fluid inside the uterine cavity, and confirmed that S.S. had an intrauterine as opposed to an ectopic pregnancy. Dr. McNeill never saw the fetus in the TVS. He did not attempt to determine the gestational age of the fetus using the sonogram. S.S. wanted to terminate the pregnancy. Dr. McNeill, did not perform terminations of pregnancies. Therefore, he noted in his chart that S.S. would be referred to Respondent. While S.S. was in Dr. McNeill's office, he called Respondent on the phone. Dr. McNeill told Respondent the following: (1) Dr. McNeill had performed a bimanual pelvic examination of S.S.; (2) Dr. McNeill had done a TVS scan on S.S.; (3) S.S. was 12 weeks or three months pregnant by examination and by scan; (4) S.S.'s pregnancy was intrauterine; (5) S.S. was a Norplant failure; and (6) S.S. wanted to terminate the pregnancy. Respondent agreed to see S.S. the next day. On October 31, 1995, S.S. went to Respondent's office to terminate the pregnancy. The history she provided indicated that she was unsure of the exact date of her last menstrual period, but that it was in August of 1995. A physical examination revealed that S.S. was 27 years old, that she was five feet, 10 inches tall, and that she weighed 173 pounds. S.S. reported that she initially thought her weight gain of 15-20 pounds was due to her use of Norplant. Respondent noted in his chart that Dr. McNeill referred S.S., after a sonogram, which indicated a 12-week pregnancy. Respondent performed a bimanual pelvic examination of S.S. Her fundal height was below her umbillicus. She did not have a gravid abdomen. If she had been 30 weeks pregnant, the fundus of the uterus would have been between her umbilicus and her rib cage. In that event, she would have appeared pregnant to a layperson. During Respondent's pelvic examination of S.S., he did not detect any fetal movement. Generally, a physician will feel fetal movement in patients who are 20 weeks pregnant unless they are morbidly obese. In this case, S.S. was not a difficult patient to examine. After performing a bimanual pelvic examination, Respondent noted in his chart that S.S. was "12 weeks by scan, 16 by size." Respondent performed the pelvic examination with the intent of determining the position and contour of the uterus as well as its size. He did not attach any significance to difference in the size of the uterus as reported by Dr. McNeill and as determined by his own examination because he had experienced such discrepancies in prior cases. It is an accepted standard in medical practice that determinations of gestational age by obstetricians performing separate bimanual pelvic examinations on the same patient can vary plus or minus four weeks. A TVS is more accurate than a bimanual pelvic examination in determining the gestational age of a fetus. Therefore, Respondent was justified in concluding that S.S. was 12 weeks pregnant based on Dr. McNeill's statements. This is true despite Respondent's personal findings to the contrary. Respondent did not perform a TVS on S.S. His references to "12 weeks" and/or "12 weeks by scan" all relate to Dr. McNeill's statement during the prior telephone conversation. The standard of care for obstetricians and gynecologists does not require a TVS to determine gestational age before performing a pregnancy termination. When Respondent commenced the termination procedure, he believed S.S.'s pregnancy was in its first trimester. He originally intended to perform the abortion using a dilatation and evacuation with suction procedure. He selected a size 12 cannula, or suction tube, only to remove fluid and to bring tissue within the grasp of his forceps. Respondent never uses a larger cannula due to the risk of injuring a patient. After sedating S.S. and performing a paracervical block, Respondent dilated the uterus. The process of dilation artificially ruptured the membranes of the amniotic sac. Respondent then observed a discharge of amniotic fluid, port wine in color. There was more amniotic fluid than one would expect in a 12-week gestation. The port wine color of the amniotic fluid indicated fetal demise at an undetermined time prior to the termination procedure. Amniotic fluid normally is clear to yellowish in color. Fetal demise causes placental separation with leakage of bloody fluid into the amniotic fluid. The darker the fluid, the longer the period of fetal demise. There is no evidence that Respondent, by rupturing the membranes, did anything which caused or contributed to the fetal death. At that point, Respondent performed another bimanual pelvic examination. The examination, under sedation, revealed that S.S. was approximately 18 to 19 weeks pregnant. Respondent also saw the cord, which was the size of a pencil, indicating more than a 12 week pregnancy. He then decided that S.S. should be admitted to the hospital to complete the procedure using pitocin augmentation. This was necessary to avoid any complications such as perforation or bleeding. Respondent advised S.S. of his decision to admit her to the hospital and she agreed. Respondent also called Dr. McNeill to inform him about the discrepancy in gestational age as revealed by the TVS and its actual size. Respondent subsequently admitted S.S. to the hospital's obstetrical/gynecological nursing floor on 23-hour observation. His admission note indicates that the fundal height was 19 centimeters. Around 20 weeks of pregnancy and beyond, the fundal height in centimeters usually equals the gestational age in weeks. After admission to the hospital, S.S. underwent a complete blood count. Her white blood count was abnormally high with a "left shift." The rupture of membranes during a normal pregnancy termination does not cause a white count to elevate or shift left. A non-viable pregnancy that is attempting to spontaneously abort without success will cause that result. Pursuant to Respondent's order, pitocin was administered to S.S. to stimulate uterine contractions. Soon thereafter, S.S. began to complain of lower abdominal pain, indicating the start of labor. Seven hours later, S.S. delivered a stillborn fetus. As a general rule, a non-term pregnancy would not deliver that rapidly unless there were some underlying processes, such as intrauterine fetal demise. The fetus was delivered with the cord intact. Then the placenta was delivered intact. The nurse's notes do not indicate that the cord was ever cut and clamped, which would have been the practice in a delivery room on the labor floor. A labor and delivery nurse came to the floor with a scale. The nurse's notes state that the fetus weighed three pounds, twelve ounces. However, there is no evidence that the fetus was weighed separate and apart from the cord and placenta. A birth weight of three pounds, twelve ounces, is consistent with a gestational age of thirty-two weeks to thirty- four weeks. Even so, intrauterine fetal demise results in fetal absorption of amniotic fluid, which will increase its weight. A placenta alone can account for up to 40 percent to 45 percent of the fetal body weight. Weight alone is not medically appropriate to determine gestational age. Other factors that should be considered include the following: fused eyes, fetal creasing, scrotal folds, breast buds, skin, foot length, hand size hair, and etc. In this case, the evidence is not clear and convincing that the fetus was 32-34 weeks, based solely on a recorded birth weight that may or may not have included the cord and placenta. This is especially true in light of persuasive evidence indicating that the fetus was less than 20 weeks and that fetal demise took place before the termination procedure. S.S. suffered no hemorrhaging, hypertension, loss of fertility, failure of blood to coagulate, shock, uterine perforation, exploratory laparotomy or a total abdominal hysterectomy as a result of the procedure performed by Respondent. The fetus was sent to the morgue and subsequently discharged to a funeral home. An autopsy was not performed. There were no pathology reports created regarding the fetus. Respondent saw S.S. at the hospital on the morning of November 1, 1995. He discharged her to go home later a couple of hours later.
Recommendation Based on the forgoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That Petitioner enter a final order dismissing all charges against Respondent. DONE AND ENTERED this 28th day of June, 2000, in Tallahassee, Florida. SUZANNE F. HOOD Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 28th day of June, 2000. COPIES FURNISHED: Richard M. Ellis, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Roy Lewis, Esquire 203 Washington Street Jacksonville, Florida 32202 Angela T. Hall, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
