Findings Of Fact John D. Elder is a site worker at Port St. Lucie High School, having first been employed by the St. Lucie County School Board as a temporary employee in the summer of 1993. When first employed, Mr. Elder rejected the option to enroll in the employer's insurance plan. In September 1993, Mr. Elder was given an employer's insurance form allowing ninety days for enrollment. On November 12, 1993, he completed the form and became eligible for certain benefits on January 1, 1994. The St. Lucie County School Board Medical Benefit Plans, in which Mr. Elder enrolled, excludes coverge for pre-existing conditions until the end of 12 months of continuous coverage. The plans include the following definitions: A pre-existing condition is an injury, sickness or pregnancy or any condition related to that injury, sickness or pregnancy, where a diagnosis, treatment, medical advice or expense was incurred within twelve (12) months prior to the effective date of this coverage. Pre-existing condition will also include any injury, sickness or pregnancy or related condition that manifested itself twelve (12) months prior to the effective date of this coverage. Pre-existing condition will also include the existence of symptoms which would cause an ordinarily prudent person to seek diagnosis, care or treatment within twelve (12) months prior to the effective date of this coverage. (Emphasis Added.) From 1985 to 1988, Mr. Elder was treated by Dr. Urban who, on March 24, 1988, performed an electrocardiogram ("EKG"), which was normal. Dr. Urban treated Mr. Elder for respiratory illnesses, such as bronchitis and pleurisy, for back and shoulder muscle spasms, bursitis/tendonitis, and for high blood pressure. On September 21, 1988, Mr. Elder first saw Dr. Richard Dube. On that day, his heart rate was 62, as compared to the normal range of 60 to 100. In October 1988, Dr. Dube treated Mr. Elder for an inflammation of the muscle behind his shoulder. In December 1988 and January 1989, he treated Mr. Elder for high blood pressure and headaches. In July 1991, Mr. Elder called an ambulance and was taken to the hospital complaining of pain in his neck, across his shoulders, and down his arms. Among other tests, an EKG was performed. The diagnosis was tendonitis in his right shoulder. Later that same year, Mr. Elder complained of heart burn. Dr. Dube treated him for epigastric distress and high blood pressure. Blood test analyses of his cholesterol and high, low and very low density lipid levels indicated a cardiac risk factor of 10.3 for Mr. Elder, which is more than twice the standard male risk factor of 5.0. Dr. Dube ordered blood tests again in January 1993, at which time Mr. Elder's cholesterol and high density lipid levels were still high, but had decreased, reducing the cardiac risk factor to 8.0. Dr. Dube also referred Mr. Elder for an ultrasound of the gallbladder, which was diagnosed on January 29, 1993, as having calcification, which could represent a gallstone, and probably having a small polyp. At the same time he treated Mr. Elder for carpal tunnel syndrome and temporomandibular joint syndrome ("TMJ"). Most recently, on July 27, 1993, the same tests were repeated. With cholesterol in the normal range, the cardiac risk factor was decreased to 6.5. In the fall of 1993, Mr. Elder's complaints were diagnosed as episgastric reflux. To reassure Mr. Elder, Dr. Dube ordered another EKG, which was performed on November 23, 1993, and was normal. On January 3, 1994, Mr. Elder's complaints of ongoing pain caused Dr. Dube, who suspected he had a hiatal hernia, to refer him to Dr. Dan G. Jacobson for an upper endoscopy. Dr. Jacobson recorded a history of episgastric/chest pain, hypertension, ulcers and arthritis. Dr. Jacobson also noted a family history described as "remarkable for heart problems, heart attack." The admitting diagnosis was "history of episgastric pain refractory to medical therapy." Dr. Jacobson performed the endoscopy and diagnosed mild stomach gastritis. Based on a two week history of epigastric and chest pain, and his conclusion that the pain was too severe to result from the endoscopy findings, Dr. Jacobson consulted a cardiologist. Dr. Robert N. Blews, a cardiologist, saw Mr. Elder in the hospital. The history taken by Dr. Blews noted (1) that Mr. Elder's father died of a heart attack at age 68, and that his mother had coronary bypass surgery at age 48 and died at age 59, (2) that the onset of "chest tightness" was approximately one year prior, and (3) that he has a history of cervical spine disease. Dr. Blews' notes also reflected a change in the pattern of the chest pains in the last one to two months, and additional changes in the last two weeks. The longest episodes of pain were lasting from 20 to 30 minutes, with associated sweating and shortness of breath. Mr. Elder also told Dr. Blews that the pain could be with exercise, at rest, could awaken him, and occurred while he was just walking to his car. The report describes Mr. Elder as having a history of smoking. The EKG which Dr. Blews ordered on January 8, 1994 showed a major blockage on the left side of the heart, and is significantly different from all of the prior EKGs, including that taken on November 23, 1993. Dr. Blews concluded that Mr. Elder was having angina, or a decrease in the blood supply to his heart two weeks, two months, and a year before January 1994. Mr. Elder's wife, Florinda Elder, has been aware of his complaints of stomach problems for 10 years, but had no knowledge of his heart problems until January 1994. She was not aware of his having ever smoked or complained of shortness of breath. Although she was at the hospital, Mrs. Elder was not in the room when Dr. Blews took her husband's medical history. Mr. Elder's shoulder and muscle aches, and cervical spine pain are the result of a serious car accident in 1969. The pains are aggravated by cold weather. Mr. Elder claims to have been under the effects of anesthesia at the time Dr. Blews took his medical history, and denies having had a year of chest tightness, shortness of breath, or difficulty walking to his car. He has not smoked for 20-25 years, which is not inconsistent with Dr. Blews' report of a "history of smoking." Mr. Elder's attempt to undermine Dr. Blews history is specifically rejected. The McCreary Corporation is the administrator of the St. Lucie County School Board's self-insurance plan, which contracts with a consultant, Independent Health Watch. Kay Trentor, R.N., reviewed the claims submitted by Mr. Elder, and concluded that his coronary artery disease was a pre-existing condition. In part, Ms. Trentor was relying on Dr. Blews history of a year of "chest tightness." Mr. Elder's records were also sent for peer review, to two other consultant organizations, Professional Peer Review, Inc. and Medical Review Institute of America, Inc. They, in turn, sent the records to Board certified cardiologists, with cardiovascular disease subspecialties. The first report concludes that Mr. Elder "should have known that he had coronary disease because he had multiple risk factors for heart disease," and that "if he was reasonably prudent he would have had this taken care of during the time he was having chest pain walking to the car." The second peer review report also notes a year of chest tightness, with symptoms worsened "over the two months preceding the admission, but . . . not recognized as cardiac until the hospitalization on January 7, 1994." The report concludes that coronary artery disease was not diagnosed until after the effective date. The second report was prepared by Ronald Jenkins, M.D., who believes that Drs. Dube and Jacobson, "seemed to be focusing on gastrointestinal diagnoses . . . and had kind of missed the boat, so to speak . . .," but that "an ordinarily prudent person with John Elder's symptoms which he reported prior to January 1, 1994, [would] have sought medical treatment for those symptoms." Coronary artery disease takes years to develop, but is erratic in manifesting itself, with some people having no symptoms to severe symptoms over a matter of hours. Dr. Dube described it as "silent" coronary disease. Dr. Blews estimates that a heart attack is the first symptom in 40 percent of patients. There is no dispute that Mr. Elder has had other medical conditions, including TMJ, arthritis, and gastroenterological problems. Dr. Jenkins believes the most important manifestation of coronary artery disease was upper precordial chest tightness going to the left upper extremity as well as to the throat. When the history indicates that the tightness occurs with exercise, according to Dr. Jenkins that gives 90 percent confidence that it is anginal chest pain. That confidence level increases to 95 percent when he notes that Mr. Elder told Dr. Blews that chest discomfort occurs when he walks to his car. Without that history, however, Dr. Jenkins would not be able to conclude that the chest discomfort is due to heart disease or that the cardiac condition manifested itself prior to January 1, 1994. Dr. Jenkins described chest heaviness, aggravated by being in cold weather, as a symptom of coronary disease. The same pain without multiple risk factors, occuring irregularly, is a reason for "looking into other alternative diagnoses." Dr. Jenkins also acknowledges that episgastric reflux can cause chest discomfort and throat pain, and that cervical spine degenerative disc disease can cause a radiation of symptoms into the upper extremities, as it did when Mr. Elder called an ambulance in 1991. Dr. Blews did not have trouble getting a complete, detailed history from Mr. Elder. He typically has to elicit a more specific description from patients complaining of chest discomfort. He gives choices such as pain, burn, stab, jab, tight, squeeze or pressure, from which Mr. Elder chose "tight." Dr. Blews also found that Mr. Elder had chest wall pain in several spots or fibrosistitis, which is not a symptom of heart disease. Chest tightness could also be attributable to asthma, according to Dr. Blews, but with radiating pain into the left arm, jaw, and throat, shortness of breath, and sweating, he was certain Mr. Elder had heart disease. All of the doctors agree that Mr. Elder's heart disease existed before January 1, 1994, and that he had no diagnosis, treatment, medical advise or expense related to heart disease in the 12 months prior to January 7, 1994. There is no evidence that he was ever evasive or uncooperative with doctors. On the contrary, Mr. Elder was consistently described in doctor's notes and hospital records as anxious or concerned about his health. Coronary artery disease had not manifested itself to Mr. Elder or his doctors prior to Dr. Jacobson's decision to consult with Dr. Blews. "Manifest" is defined in Respondent's exhibit 9, a page from the International Classification of Diseases, 9th Revision, 1995, or ICD-9, as "characteristic signs or symptoms of an illness." The doctors who testified, in person or by deposition, described every sign or symptom experienced prior to Dr. Blews' consultation, as also being a sign or symptom of Mr. Elder's other medical conditions. Mr. Elder's symptoms might have been diagnosed as also indicating that he had heart disease, if he had been referred to a cardiologist sooner. There is no factual basis to conclude that Mr. Elder, or any ordinarily prudent person, should have sought diagnosis, care, or treatment for heart disease when, in fact, his doctor reassured him that his EKG was normal.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Respondent enter a Final Order approving Petitioner's claim for payment of medical expenses in the amount stipulated by the parties. DONE AND ENTERED this 12th day of July, 1995, in Tallahassee, Leon County, Florida. ELEANOR M. HUNTER 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 12th day of July, 1995. APPENDIX TO RECOMMENDED ORDER, CASE NO. 95-0373 To comply with the requirements of Section 120.59(2), Florida Statutes (1993), the following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact. Accepted in preliminary statement and Findings of Fact 2. Accepted in Findings of Fact 3. Subordinate to Findings of Fact 3. Accepted in Findings of Fact 22. Accepted in Findings of Fact 5-8. Accepted in Findings of Fact 5-8 and 12. Accepted in Findings of Fact 7 and 10. Accepted in Conclusions of Law. Accepted in or subordinate to Findings of Fact 6. Respondent's Proposed Findings of Fact. 1. Accepted in Findings of Fact 1 and 2. 2-3. Accepted in Findings of Fact 2. 4-5. Accepted in Findings of Fact 3. Accepted as corrected in Findings of Fact 23. Accepted in Findings of Fact 9. Accepted in Findings of Fact 8 and 9. 9-12. Accepted in or subordinate to Findings of Fact 9. 13-15. Accepted in Findings of Fact 20. Accepted in Findings of Fact 22. Accepted in or subordinate to Findings of Fact 20. Accepted in or subordinate to Findings of Fact 15-23. Accepted in preliminary statement and Findings of Fact 13. Accepted in or subordinate to Findings of Fact 14-16. Accepted in Findings of Fact 14 and 15. Accepted in Findings of Fact 16. Accepted in Findings of Fact 8. Accepted in Findings of Fact 9 and 20. Accepted in Findings of Fact 23. Accepted in Findings of Fact 17. Accepted in Findings of Fact 23. Accepted, but Dr. Dube's testimony was found credible and corroborated by his notes. COPIES FURNISHED: John T. Kennedy, Esquire The Injury Law Offices of John T. Kennedy 309 East Osceola Street Suite 306 Stuart, Florida 34994 C. Deborah Bain, Esquire Wicker, Smith, Tutan, O'Hara, McCoy, Graham & Lane, P.A. 1645 Palm Beach Lakes Boulevard Suite 700 Post Office Box 2508 West Palm Beach, Florida 33401 Frank T. Brogan Commissioner of Education The Capitol Tallahassee, Florida 32399-0400 Dr. David Mosme, Superintendent St. Lucie County School Board 2909 Delaware Avenue Ft. Pierce, Florida 34947-7299
The Issue The issues in this case are whether Respondent violated section 456.072(1)(bb), Florida Statutes (2008),1/ and, if so, what discipline should be imposed.
Findings Of Fact The Department is the state department charged with regulating the practice of medicine pursuant to section 20.43 and chapters 456 and 458, Florida Statutes. At all times material to this case, Dr. Diaz-Ramirez was a licensed medical doctor within the State of Florida having been issued license number ME96703. Dr. Diaz-Ramirez is board certified by the American Board of Anesthesiology and Pain Management. At all times material to this case, Dr. Diaz-Ramirez was employed by Sarasota Memorial Hospital (SMH) Physician's Services Group, as a medical director of the pain management program. On October 7, 2008, C.C. presented to Dr. Diaz- Ramirez's office for evaluation for continued treatment of her long-standing back pain. Dr. Diaz-Ramirez examined C.C. and noted her assessment as chronic low back, right leg, and hip pain with severe right L2-3 foraminal stenosis, status post L3- S1 fusion, and lumbar postlaminectomy syndrome. There was no indication on October 7, 2008, that C.C. was having problems with her sacroiliac joint. Dr. Diaz-Ramirez discussed her treatment plan with C.C. and noted the following in C.C.'s medical records: Today we reviewed the actual CT scan films from 07/10/2006. We have also reviewed her laboratories from July. The pain is persistent. It seems to be spinal in origin. We have decided to perform bilateral L2-3 transforaminal epidural steroid injections for pain management of her symptoms. She will continue with current analgesics. She was instructed to take her oxycodone every six hours. We will be performing these injections twice and we will see her in follow-up 2-3 weeks after the injections. Dr. Diaz-Ramirez signed an order for bilateral L2-3 transforaminal epidural steroid injections to be done two times. This order was on a document entitled Discharge Instructions.2/ When the order for the first bilateral L2-3 transforaminal epidural steroid injections was put into the scheduling system for the Sarasota Memorial Health Care System Pain Management procedure area, the procedure was erroneously scheduled as a sacroiliac joint injection. Because of the scheduling error, all of the documentation for the procedure, including the physician order for the procedure and the consent form, was filled out for a sacroiliac joint injection. On October 15, 2008, C.C. presented for bilateral L2-3 transforaminal epidural steroid injections. Prior to performing the procedure, Dr. Diaz-Ramirez examined C.C. C.C. advised Dr. Diaz-Ramirez that her pain had increased and moved. However, the pre-operative history and physical notes hand written by Dr. Diaz-Ramirez at 8:35 a.m. on October 15, 2008, state that the history and physical remain unchanged from October 7, 2008, except for a sprain of C.C.'s left ankle. Prior to doing the procedure on October 15, 2008, Dr. Diaz-Ramirez talked with C.C. and explained to C.C. that a sacroiliac joint injection would be performed. It was Dr. Diaz- Ramirez's opinion that based on the examination and her discussion with C.C. that a sacroiliac joint injection was appropriate for C.C.'s pain on that day. C.C. signed a consent form for a sacroiliac joint injection. Dr. Diaz-Ramirez performed the sacroiliac joint injection on C.C. After the procedure, Dr. Diaz-Ramirez went back to her office to dictate her notes. For the first time that day, she looked at her original order and saw that on October 7, 2008, she had ordered bilateral L2-3 transforaminal epidural steroid injections for C.C. Realizing that there had been a scheduling error, she contacted Ronda Layton (Ms. Layton), the clinical coordinator for the pain management center. This was not the first time that a scheduling error had taken place, and Dr. Diaz-Ramirez reported the scheduling error to Ms. Layton so that the problem could be addressed. Dr. Diaz-Ramirez and Ms. Layton went to the bedside of C.C. and told her that a wrong procedure had been done. C.C. was advised that she had been scheduled for bilateral L2-3 transforaminal epidural steroid injections, but a sacroiliac joint injection had been performed. C.C. was also advised that Dr. Diaz-Ramirez felt that the sacroiliac joint injection was the appropriate procedure for the pain that C.C. was experiencing that day. After talking with C.C., Dr. Diaz-Ramirez dictated her report on October 15, 2008. She noted that her pre-operative diagnoses were "[l]eft low back pain, sacroiliac pain and lumbar spinal stenosis." This is the first time that Dr. Diaz-Ramirez specifically noted that C.C. was experiencing sacroiliac pain. Her notes further stated: The patient is a [redacted] year-old [redacted] patient with chronic low back pain with lumbar spinal stenosis scheduled for bilateral L2-L3 transforaminal epidural steroid injection. We performed sacroiliac joint steroid injection for management of her symptoms. On October 28, 2008, Dr. Diaz-Ramirez made an addendum to her report dated October 15, 2008. The addendum stated: After the procedure was done, it was discovered that the intended scheduled procedure was not performed. The patient was made immediately aware and full disclosure was made. Under the circumstances of the evaluation this morning, the sacroiliac joint injection would not have been an inappropriate procedure to perform for this patient and she actually received immediate relief in the area of her pain. The patient understood. She agrees and she will be seen for her intended scheduled procedure of a bilateral transforaminal epidural steroid injection at L2-L3 at her next visit. On October 15, 2008, C.C.'s pre-operative pain level on a scale of one to ten, with ten being the worst and one being the least, was ten. Her post-operative pain level was seven, and her pain level at discharge was between nine and ten. C.C. was scheduled for bilateral L2-3 transforaminal epidural steroid injections for October 22, 2008, and Dr. Diaz-Ramirez performed the scheduled injections on that date. C.C.'s pre-operative pain level on October 22, 2008, was seven. Her post-operative pain level was four, and her discharge pain level was between four and five.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Dr. Diaz-Ramirez did not violate section 456.072(1)(bb) and dismissing the Administrative Complaint. DONE AND ENTERED this 16th day of February, 2011, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 16th day of February, 2011.
The Issue Whether petitioner should take disciplinary action against respondent for the reasons alleged in the administrative complaints?
Findings Of Fact Respondent Patrick J. McCarthy has practiced obstetrics and gynecology in Tallahassee, Florida, since 1976. He "qualified as a doctor in 1958" (T.215) at the University of Wales, did residencies in Canada, including three years in obstetrics and gynecology at McGill University, and practiced in New Hampshire, before coming to Florida, where he is duly licensed to practice. Board certified here and abroad, Dr. McCarthy now delivers 200 to 250 babies a year. Over his career, he estimates, he has delivered 7,000 to 8,000 infants. T.225. In 1981, he "recertified in obstetrics and gynecology in the American boards." T.236. C.H. On November 1, 1984, Dr. McCarthy admitted C.H., a 23-year old mother of one whom he had been seeing in his office during her second pregnancy. Labor had begun shortly after midnight, about five hours before C.H. arrived at the hospital. At quarter past six that morning, when C.H.'s cervix had dilated to a diameter of seven or eight centimeters, respondent did not accede to C.H.'s request for epidural anesthesia. At 6:36 a.m., however, C.H. received Demerol and Phenergen, medicines Dr. McCarthy ordered, and later got local anesthesia, a "pudendal block" designed to numb the area in which an episiotomy was eventually performed. Four minutes later C.H. was taken to the delivery room. C.H.'s cervix was fully dilated by ten of seven. At 6:58 a.m., Dr. McCarthy applied a vacuum extractor, but he did not succeed in delivering the baby's head until 7:20, after he had resorted to low forceps. His head out, the baby's shoulder lodged behind his mother's pubic symphysis. All ten pounds and seven ounces were stuck. Once the head is delivered, the rest of the baby should be delivered within five or six minutes to avoid the risk of damaging or losing the child. The umbilical cord's function can be compromised if it is pinched between the baby and strictures in the birth canal. At this point, Dr. McCarthy performed what he called a Wood's maneuver. Wood's maneuver, also known as the corkscrew maneuver, was unquestionably acceptable practice at the time, if properly performed "by applying pressure on the back of the [baby's] shoulders." T.134. Currently the preferred initial response to shoulder dystocia is to bend and raise (if she is supine) the mother's legs to reposition the pubes. Named after a Dr. McRoberts, this approach was used in Tampa in 1984, but was apparently unknown to Dr. McCarthy at that time. In describing C.H.'s baby's birth, which took place at 7:23 on the morning of November 1, Dr. McCarthy wrote in the chart: "Marked shoulder dystocia -- shoulders rotated through 180o." Joint Exhibit No. 1. Later, asked about these events while under oath, he answered: I rotated the head and shoulders. Q. How did you do that? A. Thats called -- it's a thing called Wood's maneuver, where you are using -- you rotate the head so that the shoulders will follow it. The posterior shoulder then comes under the symphysis of the pubic. It's lower than the anterior. When you have that, then you have the baby up. Q. And in that process do you place a downward pull on the baby's head? A. No, you rotate. . . . Q. From the process of this delivery was there any injury to this baby? A. Yes, the baby had a brachial plexus palsy. Q. How did the brachial plexus palsy occur? A. Presumably when I turned the head, it stretched the nerves in the brachial plexus at the base of the neck. Q. That would have been when you turned the head in the last maneuver that you attempted or would that have been in the first maneuver when you are pulling down on the head? A. Usually when you turn the head. Q. In this case do you know when the injury occurred? A. Usually it happens when you turn the head. It's a twisting motion, because this is the greatest stretch motion. Petitioner's Exhibit No. 2, pp. 51-3. Dr. McCarthy's testimony at hearing that he did not turn the baby's head (except by turning the baby's shoulders) in performing what he called a Wood's maneuver has not been credited. Whether or not (as Dr. McCarthy assumed) the twisting caused the brachial plexus palsy with which the child is afflicted, rotating the baby's head "so that the shoulders w[ould] follow it" was a departure from minimally acceptable practice. On this point, every expert who testified was in agreement. The records do not indicate whether C.H. was catheterized before her delivery. Presumably she was not, but petitioner did not allege and the evidence did not show that she needed a urinary catheter. Petitioner did not establish any dereliction on respondent's part in his keeping of records on C.H. or her delivery, aside from the elliptic description he gave of his rotary manipulation. M.B. Before the day she was delivered, M.B. had been under the care of M. J. Moreton, M.D., who was apparently unavailable at twenty past eleven o'clock on the morning of October 9, 1984, when M.B., then the 28-year-old mother of one child, arrived at Tallahassee Memorial Regional Medical Center. Irregular contractions had begun earlier that morning, and persisted until that afternoon, when Dr. McCarthy, who had undertaken M.B.'s care, directed that she be given a drug "to get her into good labor." Joint Exhibit No. 2. The drug to induce regular contractions was administered at four o'clock. She received epidural anesthesia at intervals. Vomiting, begun at ten o'clock that night, a half hour before her cervix was fully dilated, interfered with M.B.'s ability to push. Sporadically, the fetal monitor indicated pulse rates as low as 70. Dr. McCarthy used a vacuum extractor to deliver the baby's head, and encountered shoulder dystocia. At hearing, Dr. McCarthy recounted his use of a procedure called Hibbald's maneuver, one of a number of accepted techniques for dealing with shoulder dystocia: . . . I told the nurse to apply fundal and suprapubic pressure and I grasp[ed] the head and pulled it down approximately a forty-five degree angle . . . I was applying moderate traction to the head and the baby delivered. T.258-9. Two or three minutes after the delivery of the head, M.B.'s baby was born at 10:47 p.m. on October 9, 1984. "The only unusual thing about the baby, apart from the brachial plexus palsy, was that there was a cord around the shoulder," (T.259) presumably the cause of the intermittently depressed fetal pulse rate. Dr. McCarthy acknowledged that he "could have used many maneuvers," (T.260) other than Hibbald's. He ascribed his exclusive use of Hibbald's maneuver to the shortness of the time it took to deliver the baby. At some point, reliance on a technique that is not succeeding, to the exclusion of others that might dislodge a baby without causing brachial plexus palsy, a known complication of shoulder dystocia, falls below minimally acceptable standards of practice. During the two- or three-minute interval between delivery of the baby's head and extrication of his shoulder, Dr. McCarthy "checked the baby to see if there was a cord around the neck," (T.261) and suctioned fluid from the baby's nostrils. The evidence did not clearly show how long he applied traction before the baby was delivered. An expert testifying for petitioner said that a patient with epidural anesthesia "in general is unable to void . . . and . . . the bladder can enlarge . . . and can interfere . . . [so that] it's good obstetrics, before performing a forceps or vacuum delivery to catheterize. . . ." T.55. But there was no testimony that failure to catheterize fell below minimally acceptable standards, nor any testimony to establish M.B.'s particular circumstances. The evidence established no deficiencies in respondent's recordkeeping with regard to M.B. or her delivery.
Recommendation Although later adopted and, therefore, not determinative, see Willner v. Department of Professional Regulation, 563 So.2d 805 (Fla. 1st DCA 1990), Rule 21M-20.001(2)(t), Florida Administrative Code, specifies penalties for violating Section 458.331(1)(t), Florida Statutes (1991), ranging from two years' probation to license revocation, together with a fine of $250 to $5000, depending on aggravating and mitigating circumstances set out in Rule 21M- 20.001(3), Florida Administrative Code. Upon consideration of the foregoing findings and conclusions, and the length of time that has elapsed since the birth of C.H.'s baby, it is RECOMMENDED: That the Board of Medicine place respondent on probation for a period of five (5) years, on condition that he attend a minimum of thirty (30) hours per year of category I continuing medical education courses, including, within the first ninety (90) days of probation, ten (10) hours of courses on how to manage shoulder dystocia; and on further condition that he perform 250 hours of community service under the auspices of the county health department, if needed, during each year he is on probation; provided, however, that the question of penalty be reopened, in the event respondent fails to abide by the conditions of probation or to make reports to the Board on or before the tenth day of each month, reflecting compliance with the conditions of probation. DONE and ENTERED this 4th day of February, 1993, at Tallahassee, Florida. ROBERT T. BENTON, II, 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 4th day of February, 1993. APPENDIX Petitioner's proposed findings of fact Nos. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, both 17s, the first 18 and 19 regarding C.H. and Nos. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 13, 14, 15, and 16 regarding M.B. have been adopted, in substance, insofar as material. With respect to petitioner's proposed findings of fact Nos. 16 and the second 18 regarding C.H., respondent unquestionably exposed the baby to the risk of serious injury, and more than likely caused the brachial plexus palsy. With respect to petitioner's proposed findings of fact Nos. 12, 18, 19, 20, 25 and 27 regarding M.B., Dr. Brauner's testimony that persisting with Hibbald's maneuver for longer than 60 seconds would fall below minimally acceptable standards has been credited, but the evidence was not clear and convincing as to the exact length of time Dr. McCarthy applied traction. Petitioner's proposed findings of fact Nos. 17, 22, 26, and 28 and 29 regarding M.B. pertain to subordinate matters. With respect to petitioner's proposed findings of fact Nos. 21 and 23 regarding M.B., the evidence did not clearly and convincingly establish that respondent's use of the Hibbald maneuver caused the brachial plexus palsy, although it is entirely possible that it did. With respect to petitioner's proposed finding of fact No. 24 regarding M.B., the evidence showed that Dr. McCarthy intervened to accelerate delivery of the head, but his deployment of the vacuum extractor was not alleged to have been below standards, and may well have been justified by the intermittently depressed pulse the baby exhibited and the mother's difficulty pushing. Respondent's proposed findings of fact Nos. 1, 2, 3, 4, 10, 12, 14, 15, 20, 27, 28, 29, 30, 31, 32, 37 and 40 have been adopted, in substance, insofar as material. With respect to respondent's proposed finding of fact No. 5, C.H. arrived at the hospital before 5:45. Respondent's proposed findings of fact Nos. 6, 7, 8, 9, 11, 17, 18, 22, 33 and 34 pertain to matters that are subordinate or immaterial altogether. With respect to respondent's proposed finding of fact No. 13, Wood's maneuver requires pressure on the shoulders, not the head. With respect to respondent's proposed finding of fact No. 16, use of the vacuum extractor preceded knowledge of the shoulder dystocia. With respect to respondent's proposed findings of fact Nos. 19 and 21, he did not perform the maneuver properly. With respect to respondent's proposed finding of fact No. 23, the "clarification" has not been credited. With respect to respondent's proposed findings of fact Nos. 24 and 25, the obstetrician does not have discretion to fail to meet minimum standards. With respect to respondent's proposed finding of fact No. 26, the precise etiology of the brachial plexus palsy was not established. With respect to respondent's proposed findings of fact Nos. 35, 36, 38, 39, and 41, petitioner failed to prove clearly and convincingly that respondent's management of the shoulder dystocia in M.B.'s case fell below standards, but neither did the evidence establish that it met standards. COPIES FURNISHED: Gerald B. Sternstein, Esquire 600 First Florida Bank Building Post Office Box 2174 Tallahassee, FL 32316-2174 Richard A. Grumberg, Esquire Department of Professional Regulation 1940 N. Monroe Street Tallahassee, FL 32399-0750 Jack McRay General Counsel 1940 North Monroe Street Tallahassee, FL 32399-0792 Dorothy Faircloth Executive Director Department of Professional Regulation Medicine Board 1940 North Monroe Street Tallahassee, FL 32399-0792
Findings Of Fact The Petitioner is the state agency charged by statute with regulating the practice of medicine in Florida. At all times material to this case, John Isaac Delgado (Respondent) has been a physician in the state, holding Florida license number ME 0054871. The Respondent's last address of record is 7820 North Armenia Avenue, Tampa, Florida, 33629. The Respondent has been licensed to practice in Florida since 1989. At about 8:30 p.m. on February 9, 1992, Patient W. S. (Patient) presented to the Emergency Room at St. Joseph's Hospital, Tampa, apparently complaining of right lower quadrant pain. Immediately prior to being seen at the emergency room, the Patient had been playing cards with friends and had apparently fainted. The Patient, a 74 year old obese white male, had a history of diabetes, coronary artery disease and had a previous myocardial infarction. At the emergency room, the Patient was initially examined by John C. Siano, M.D. Dr. Siano ordered chest and abdominal x-rays. The Respondent was the internist on call at the time the Patient was examined in the emergency room. Dr. Siano contacted the Respondent and notified him of the situation. The Respondent examined the Patient at about 10 p.m. The examination was extensively documented. At the time the Respondent initially examined the Patient, the Patient provided an incomplete summary of his symptoms. The Patient had apparently informed emergency room personnel of severe pain; however, this information was not provided to the Respondent. The Respondent was aware only of intermittent abdominal pain. The Patient's emergency room records were missing at the time of the Respondent's examination. The Respondent unsuccessfully attempted to locate the Patient's records during his examination of the patient. Upon examination, the Respondent determined that the Patient's blood pressure was within normal range and was stable. The Patient was alert and oriented. Vital signs were normal. The patient appeared to be in stable condition. While in the emergency room, the Patient had a bowel movement which tested positive for the presence of blood. A nasogastric tube exiting from the Patient indicated "coffee grounds" material. These factors are indicative of a gastrointestinal problem. The presence of blood in the intestinal tract and abdominal pain is indicative of a gastrointestinal disorder. The evidence fails to establish that the patient presented an emergency condition at the time of the Respondent's examination. Back pain is a symptom of an expanding abdominal aortic aneurysm. An expanding aneurysm presses against nerves and muscle in the back and sides of a patient. In this case, the aneurysm was of considerable size; nonetheless, the evidence fails to establish that the Patient informed the Respondent of severe back pain. Severe continuing abdominal pain may be a symptom of a ruptured abdominal aortic aneurysm. The evidence fails to establish that the Patient informed the Respondent of severe continuing abdominal pain. There was no palpable pulsatile mass in the Patient's abdomen which would have been indicative of an aneurysm. There was no "bruit" sound emanating from the patient's abdomen. Such sounds are indicative of an aneurysm. There was no asymmetry of pulses in the Patient's legs which would have been indicative of the aneurysm. Hypotension, such as may result in fainting, can be indicative of an aneurysm. The patient was hypotensive when he arrived at the emergency room; however, treatment with intravenous fluids brought the Patient's pressure back to a normal range within a few minutes, indicating that internal bleeding was not significant. Based on the symptoms described by the patient and on review of the patient's condition, the Respondent's tentative diagnosis was upper gastrointestinal bleeding, likely peptic ulcer disease with bleeding secondary to chronic aspirin usage and colonic polyps. There was also a suggestion of acute diverticulitis with associated bleeding. The Respondent ordered a series of abdominal x-rays be taken. The Respondent ordered appropriate diagnostic studies based on his tentative diagnosis. The tests were scheduled for the morning. The Respondent also requested a surgical consultation, which was also scheduled for the morning. Based on the examination and discussion with Dr. Siano, the Respondent admitted the Patient to a regular floor for further observation. At the time the Patient was admitted, the Respondent had not reviewed the results of the abdominal x-rays. The Respondent did not review the x-rays prior to leaving the hospital that night. The evidence is insufficient to establish that the Respondent's failure to review the x-rays prior to admission or prior to leaving the hospital for the night violated the acceptable standard of care. Based on the patient's condition as expressed to the Respondent and on the results of the examination, the evidence fails to establish that the Respondent should have diagnosed the situation as an aneurysm. The mere existence of an aneurysm is not a surgical emergency. Whether to surgically treat an aneurysm depends on a number of other factors. A ruptured aneurysm is an emergency life threatening condition. Time is critical when responding to a ruptured aneurysm. The evidence is insufficient to establish that the Respondent knew or should have known that the Patient was suffering from a ruptured aneurysm. In the morning of February 10, 1992, a general surgical consultation was done by Frederick Reddy, M.D. Dr. Reddy examined the patient and reviewed the abdominal x-rays which had been taken on the Respondent's orders. According to Dr. Reddy, at the time of his exam the patient complained of intermittent abdominal pain, and said that he had a history of back pain, but did not complain of back pain at that time. Dr. Reddy's review of the x-rays indicated the presence of calcification. While calcification is indicative of an possible aneurysm, the evidence fails to establish that the Patient's aneurysm is clearly indicated by the x-rays. Dr. Reddy saw no indication of rupture, but referred the case to a radiologist and ordered a CT scan on the radiologist's recommendation. The CT scan indicated that an aneurysm had ruptured. The Patient was taken to surgery where G. K. James, M.D. repaired the ruptured aneurysm and performed an aortobifemoral bypass graft. The Patient's condition deteriorated and he expired on February 10, 1992. The evidence fails to establish that the outcome of the case would have been different had the Respondent diagnosed the problem as a ruptured abdominal aortic aneurysm or had the surgical procedure been performed at an earlier time after the Patient's arrival at the hospital emergency room.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Agency for Health Care Administration enter a Final Order dismissing the Administrative Complaint filed in this case. DONE and ENTERED this 27th day of February, 1996, in Tallahassee, Florida. WILLIAM F. QUATTLEBAUM, Hearing Officer Division of Administrative Hearing The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 27th day of February, 1996. APPENDIX TO RECOMMENDED ORDER, CASE NO. 95-1981 To comply with the requirements of Section 120.59(2), Florida Statutes (1993), the following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact. The Petitioner's proposed findings of fact are accepted as modified and incorporated in the Recommended Order except as follows: 1. Rejected, not supported by cited evidence. Petitioner's exhibit Number 1 identifies the Respondent's address as set forth herein. Rejected. The greater weight of evidence fails to establish that the x-rays revealed the presence of a ruptured aneurysm. The ruptured aneurysm was diagnosed after a CT scan and review by a radiologist. Rejected, subordinate. While the statement that the cited physician always reads his ordered x-rays is correct, the evidence fails to establish that failure to do so is a violation of the acceptable standard of care. Rejected. The cited evidence does not establish that the x-ray "very clearly" suggests the aneurysm. Rejected. The greater weight of the evidence fails to establish that the Patient described pain indicative of an aneurysm to the Respondent. Rejected. No evidence that the Respondent was aware of the statement made by the Patient. Rejected. The greater weight of the evidence fails to establish that the Patient described pain indicative of an aneurysm to the Respondent. Rejected. The greater weight of the evidence fails to establish that the Patient's condition as determined by the Respondent required an immediate consultation. Rejected. The greater weight of the evidence fails to establish that the Patient's condition as determined by the Respondent indicated a course of treatment other than as set by the Respondent. Rejected, subordinate. Rejected. Not supported by the greater weight of credible and persuasive evidence. Respondent's Proposed Findings of Fact. The Respondent's proposed findings of fact are set forth in unnumbered paragraphs, many of which fail to contain citation to the record as required by Rule 60Q-2.031(3), Florida Administrative Code. Proposed findings which cite to the record are accepted as modified and incorporated in the Recommended Order, or are otherwise rejected as subordinate or as recitation of testimony. COPIES FURNISHED: Douglas M. Cook, Director Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Jerome W. Hoffman General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Dr. Marm Harris, Executive Director Board of Medicine Agency for Health Care Administration Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792 Steve Rothenburg Senior Attorney Agency for Health Care Administration 9325 Bay Plaza Boulevard, Suite 210 Tampa, Florida 33619 Clifford L. Somers, Esquire 3242 Henderson Boulevard, Suite 301 Tampa, Florida 33609
The Issue The issue is whether Respondent is guilty of violating the applicable standard of care in the practice of optometry, the prohibition against filing reports or records known to be false, or the prohibition against fraud, deceit, misconduct, or negligence in the practice of optometry.
Findings Of Fact Respondent received his Florida optometry license in October 1982. He earned a doctorate in veterinary parasitology from the University of Florida in 1976 and an optometry doctorate from the New England College of Optometry in 1982. This case involves Respondent's failure to diagnose and treat glaucoma. Glaucoma refers to as many as 87 different types of conditions in which, in most of these conditions, intra-ocular pressure reduces the amount of blood that circulates into the optic nerve. The optic nerve consists of thousands of fibers, each of which transmits from a retinal position--anywhere from central vision to the periphery--to the portion of the brain dedicated to visual processing. Deprived of blood, fibers lose their ability to transmit from the eye to the brain. Traditionally, glaucoma has been associated with high intra-ocular pressure. In the early 1980s, nearly all professionals believed that low- or normal-pressure glaucoma did not exist. However, since the mid-1980s, opthamologists have recognized that about 25 percent of patients suffering from glaucoma do not experience high intra-ocular pressure. Optometrists arrived at the same knowledge a few years later, and general understanding of low- or normal-pressure glaucoma has increased through the 1990s. Persons suffering low- or normal-pressure glaucoma have an optic nerve that is unusually susceptible to damage from intra-ocular pressure. Such persons often display low blood pressure or fluctuating blood pressure. The differential between the greater, though normal or low, intra-ocular pressure and the low blood pressure can impede blood circulation to the optic nerve. Thus, just as persons displaying low intra-ocular pressure may suffer from glaucoma, so persons displaying high intra-ocular pressure may not suffer from glaucoma. Intra-ocular pressure is therefore not an especially definitive indicator of the presence of glaucoma, although high intra-ocular pressure remains a good indicator. The cupping of the optic nerve is another indicator of glaucoma that is not especially definitive. Cupping refers to the indentation of the optic nerve as it enters the eye. Cupping may be due to the response of the optic nerve to intra-ocular tension. However, some persons display physiological cupping, which merely reflects the physical makeup of that patient's optic nerve and does not necessarily indicate any malfunction in the nerve. The older method of determining the extent of cupping required an assessment of the color of the optic nerve. Pink is indicative of healthy tissue, and white is indicative of the cupped area. A newer method of determining the extent of cupping requires an assessment of the extent of bending of the blood vessels, which are indicative of the extent of the bending of the optic nerve fibers, which themselves cannot be seen through their entire bend. One factor that has, at all material times, been a strong risk factor for glaucoma is a family history of glaucoma, especially a maternal genetic predisposition to the disease. Obtaining a history is thus important to an early diagnosis of glaucoma. However, the linkage between high-pressure glaucoma and low- or normal-pressure glaucoma is not especially strong, so family histories, given the failure to recognize low- or normal- pressure glaucoma until recently, often do not reveal the existence of low- or normal-pressure glaucoma. After a genetic predisposition toward glaucoma (and probably more important given the failure of the relevant professional communities to recognize low- and normal-pressure glaucoma until recently), the most important indicator of glaucoma is an impairment of a person's visual field. A visual field test is the most important diagnostic test because it determines the extent to which a person may have suffered a visual loss in any part of his or her visual field. There are different types of visual field tests. The most basic visual field test consists of a mere screening. This is a confrontational field examination in which the optometrist places his or her fingers in the four quadrants of the patient's visual field and asks the patient what he or she can see. This screening has been part of the practice of optometry at all material times. Permitting a more accurate test, the Goldman visual field machine has been available since the early 1980s, although it did not become a standard piece of equipment in optometrists' offices until somewhat later. At present, the Humphrey Perimeter machine is a newer piece of equipment. The basic components of this machine have been available since the early 1980s, but not as long as the Goldman visual field machine. The Humphrey Perimeter machine supplies a light stimulus to different locations within the patient's visual field, and the patient is given a means by which to indicate electronically the location, size, and brightness of the light source. The Humphrey Perimeter machine then maps out the data, so as to provide an easily digestible, graphic display of any deficiencies in a patient's visual field. As apparent in the some of the preceding findings, expertise in the diagnosis of glaucoma has advanced considerably in the past 10 years. At the same time, regulatory and customary restraints upon the ability of optometrists started to lift about 10-15 years ago, as optometrists gained the right to dilate pupils and administer a wide range of prescription drugs, including drugs necessary to treat glaucoma. By the late 1980s, the Humphrey Perimeter machine, or other, similar forms of automated periphery machines, began to appear with regularity in the offices of optometrists. Shortly after entering practice, Respondent, in 1983, purchased the practice of David Johnson, an opthamologist. Dr. Johnson's office was located in Brooksville, which is where Respondent has maintained his practice of optometry. From the date of the purchase until sometime in 1985, Dr. Johnson practiced on a consultative basis in Respondent's office. Respondent examined R. L., who was born in 1940 or 1941, four times: November 6, 1984; June 17, 1987; October 18, 1989; and October 11, 1990. At the first, as well as the other three, office visits, an assistant performed the confrontational field screening to assess R. L.'s visual field. These tests disclosed nothing abnormal. During the first and ensuing visits, an assistant or Respondent tested R. L.'s intra-ocular pressure. These tests disclosed nothing abnormal. The notes from the first office visit state that there was no family history of eye problems. During the first visit, Respondent examined R. L.'s eyes and found a possible abnormality--cupping--in the appearance of the patient's optic nerves. Dr. Johnson was in the office at the time, so Respondent asked Dr. Johnson to examine R. L., who had previously been Dr. Johnson's patient. Dr. Johnson examined R. L. and determined that his optic nerves were normal. At the conclusion of the first visit, Respondent discussed with R. L. the cupped appearance of his optic nerve. Respondent showed R. L. intra-ocular photographs of his optic nerve and a normal optic nerve and told R. L. that his cupping was physiological. R. L. testified that he did not feel that Respondent necessarily should have detected the glaucoma until the third visit. At the second and third office visits, Respondent found that the extent of cupping had remained substantially unchanged. At the second office visit, though, R. L. reported that his mother had suffered from glaucoma. The office records reveal that his blood pressure was 108/62, which is somewhat low. By the third office visit, Respondent had purchased an automated perimeter machine for use in his office. Respondent suggested that R. L. undergo a visual field test using this machine on each of the last two visits. However, R. L. refused to do so. At the end of the third and fourth office visits, Respondent suggested that R. L. see an opthamologist, but R. L. declined to do so after the third office visit. A few days after the fourth visit, evidently following Respondent's recommendation, R. L. visited an opthamologist for an examination. In performing his examination, the opthamologist discovered that R. L. had advanced glaucoma. R. L. has since undergone glaucoma surgery to relieve intra-ocular pressure. His vision is impaired. Although an earlier diagnosis probably would have slowed the deterioration in his vision, it would not have altered the eventual outcome of the disease, which is continued deterioration in vision. The evidence is decidedly vague concerning the applicable standard of care in Brooksville, or even in Florida, at the time of each of the four office visits from 1984-1990. This was a period characterized by many changes in the understanding of glaucoma by the optometric community, as well as the opthamologic community, and by the distribution of automated perimeter equipment, which facilitates sophisticated visual field testing. Obviously, the difficulty in establishing the applicable standards of care is heightened by the fact that 9-15 years passed, following the office visits, before Petitioner referred this case to the Division of Administrative Hearings. Neither the opthamologic nor the optometric community was widely aware of the existence of low- or normal-pressure glaucoma until after the first visit. The optometric community did not become aware of the existence of this form of glaucoma until after the expiration of this six-year period. At the time of the first three visits, Respondent met the standard of care applicable to optometrists in Florida, and certainly in Brooksville, by having his staff conduct confrontation visual field examinations, testing intra-ocular pressure, and monitoring the cupping to ensure that it did not worsen. Although the cupping was relatively severe at the time of the first visit, so that it could not deteriorate significantly, Respondent had properly obtained the diagnosis of an opthamologist, who had previously cared for R. L., to support Respondent's conclusion that the cupping was merely physiological in origin. At no time did Respondent's diagnostic efforts deviate from the applicable standard of care. His acquisition of automated perimeter equipment was early for the Brooksville optometric community, and the record does not establish that the Florida optometric community widely acquired such equipment any earlier, or even at the time that Respondent did. Respondent properly suggested to R. L. during the third and fourth visits that R. L. undergo more sophisticated visual field testing, as Respondent was eager to put his new equipment to use, but R. L. declined to undergo the procedure because he felt that it was unnecessary. Likewise, Respondent properly suggested to R. L. during the third and fourth visits that R. L. see an opthamologist, but R. L. declined to do so. Respondent's records are austere, but Petitioner has failed to prove by clear and convincing evidence that Respondent did not adequately record the course of his care of R. L. The better practice would have suggested more detailed records and more detailed records prepared contemporaneous to the dates of care. However, the omissions did not establish by clear and convincing evidence a violation of the recordkeeping requirements, nor did any late entries establish by clear and convincing evidence an intent to deceive. Lastly, Respondent underwent a deposition in a civil action for damages that R. L. brought against him. The plaintiff's attorney asked Respondent: "[Have you ever had] [c]omplaints of any kind of department of regulation of any kind?" Respondent responded by asking, "From a patient or anything?" The attorney answered, "Yes." And Respondent replied, "Not that I am aware of." Respondent has been disciplined twice in the past. However, both of these situations involved Petitioner-initiated charges, which were not based on complaints from actual patients of Respondent. Petitioner has thus failed to prove by clear and convincing evidence that Respondent committed fraud or deceit in the practice of optometry by answering this vague question in the negative. It is at least as likely as not that Respondent's use of "or anything" in his responsive question meant only to restate the notion that his answer would be limited to patient-initiated charges.
Recommendation It is RECOMMENDED that the Board of Optometry enter a final order dismissing the Administrative Complaint, as amended, against Respondent. DONE AND ENTERED this 15th day of December, 1999, in Tallahassee, Leon County, Florida. ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 15th day of December, 1999. COPIES FURNISHED: Angela T. Hall, Agency Clerk Department of Health Bin A02 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701 Pete Peterson, General Counsel Department of Health Bin A02 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701 Eric G. Walker, Executive Director Board of Optometry Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0792 Thomas E. Wright, Senior Attorney Agency for Health Care Administration General Counsel's Office Medical Quality Assurance, Allied Health Post Office Box 14229 Tallahassee, Florida 32317-4229 William B. Taylor, IV Macfarlane Ferguson & McMullen Post Office Box 1531 Tampa, Florida 33601-1531
The Issue The issues for determination are whether Respondent Bernard Zaragoza, M.D., violated Section 456.072(1)(bb), Florida Statutes (2007), as alleged in an Administrative Complaint filed by the Department of Health before the Board of Medicine on June 30, 2008; and, if so, what disciplinary action should be taken against his license to practice medicine in the State of Florida.
Findings Of Fact The Parties. Petitioner, the Department of Health (hereinafter referred to as the "Department"), is the agency of the State of Florida charged with the responsibility for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. § 20.43 and Chs. 456 and 458, Fla. Stat. Respondent, Bernard J. Zaragoza, M.D., is, and was at the times material to this matter, a physician licensed to practice medicine in Florida, having been issued license number ME 67920. Dr. Zaragoza’s address of record is 3100 Coral Hills Drive, Suite 207, Coral Springs, Florida 33065. Dr. Zaragoza is certified in general surgery by the American Board of Surgery. Dr. Zaragoza has not been the subject of any investigation, claim, or complaint relating to his professional career other than this matter. Dr. Zaragoza graduated, Summa Cum Laude, from the University of Miami with a bachelors degree. He earned his medical degree from Harvard Medical School. Dr. Zaragoza performed a five-year surgical residency program at New York Medical College’s Westchester County Medical Center. During his residency, Dr. Zaragoza performed hundreds of laparoscopic procedures, including laparoscopic cholechstectomies (removal of the gallbladder). A laparoscopic surgery is a technique in which the abdomen is entered through small incisions rather than “opening up” the abdomen. Normally, for abdominal laparoscopic surgery, incisions are made at the belly button. This is the point which is usually closest to the peritoneal cavity, thus reducing the distance from the skin the surgeon must work through and the surgeon has a broader view of the abdomen. By October 2007, Dr. Zaragoza had performed in excess of 2,000 laparoscopic cholecystectomy procedures. Patient J.C. On October 1, 2007, Patient J.C., a male, 83 years of age, presented at Northwest Medical Center, located in Margate, Florida, for treatment of abdominal pain and vomiting. Patient J.C. had reported with the same symptoms a month earlier and had been diagnosed with chronic cholecystitis, a chronic inflammation of the gallbladder due to the blockage of the bile ducts by gall stones. It is a life-threatening condition. Patient J.C. was admitted by Rafael Rodriguez, M.D., who requested a consultation by Mark Shachner, M.D., Dr. Zaragoza’s partner. Dr. Shachner confirmed a diagnosis of acute cholecystitis and, in light of the failed conservative therapy which Patient J.C. had undergone since his first visit and the potential threat to his life, Dr. Shachner recommended surgery. It was concluded that Patient J.C. would undergo an attempted laparoscopic cholecystectomy. Dr. Zaragoza was to perform the procedure. It was concluded that a laparoscopic procedure was the appropriate procedure for Patient J.C. due to his medical history: atrial fibrillation, Alzheimer’s disease, hypertension, and diabetes. He had also undergone prior abdominal procedures. The parties did not dispute that a laparoscopic procedure, because it was likely to reduce post- operative complications, was the best type of surgical procedure for Patient J.C. Patient J.C., as a result of a prior gastrectomy, had a long midline incision extending from the Xiphoid upper abdomen to below the belly button. As a result of this surgery, Patient J.C. had extensive adhesions of tissue up to the midline. Patient J.C. had also undergone an appendectomy. It was concluded that, due to Patient J.C.’s condition and abdominal surgical history, rather than entering at the belly button and risking injury to any structures that were adhesed to the midline, a “right-sided” incision point would be used. The Department does not dispute the appropriateness of this decision. Unfortunately, by using a right-sided incision point, Dr. Zaragoza’s visualization of Patient J.C.’s abdominal cavity was reduced. Patient J.C. and his family were fully informed of the nature of the proposed surgical procedure and the risks, after which Patient J.C. signed a written consent for surgery. The written consent included an authorization to “take whatever action(s) and to perform whatever procedures(s) they deem necessary and advisable, which may be in addition to or different from those now planned” and an acknowledgement that the surgery to be performed “may result in perforation or injury to adjacent organs or structures.” None of the witnesses convincingly testified that the authorization included the authority to remove healthy organs or that the acknowledgement included any suggestion that a healthy organ might be completely removed. Surgery was scheduled for October 2, 2007. Dr. Zaragoza began the surgery with a right-sided approach, freeing up the area and attempting to identify important structures in the right upper quadrant of the abdomen. In particular, the important structures Dr. Zaragoza attempted to locate were the liver, colon, and the gallbladder. Dr. Zaragoza encountered extremely heavy adhesions (8 on a scale of 1 to 10) in Patient J.C.’s abdomen. Dr. Zaragoza considered the risks of continuing or switching to an open abdomen procedure and correctly concluded it was best to proceed. Dr. Zaragoza freed up extensive adhesions and was able to correctly identify the liver. Unable to identify the gallbladder and due to the extensive adhesions in the area of the intestine, Dr. Zaragoza stopped the procedure in order to retrieve a CT scan of the area and personally evaluate the images. In order to expedite receipt of the CT study, Dr. Zaragoza scrubbed out and personally walked to the radiology suite. After returning, Dr. Zaragoza read the CT scan and the radiologist’s interpretation, which indicated that the gallbladder was posterior to the transverse colon. Dr. Zaragoza returned to Patient J.C., mobilized the colon to free it from the liver and attempted to locate the gallbladder behind the colon where he expected it to be. What Dr. Zaragoza found behind the transverse colon was a dark, thickened, and solid structure in the anatomical position which the CT scan and radiologist report suggested the gallbladder would be located. While the gallbladder, which consists of a water sac, is normally soft, pink, and pliable, this is not the case with an inflamed and infected one. Given Patient J.C.’s history of chronic cholecystitis with an acute cholecystitis secondary to the blockage of bile ducts by gallstones, Dr. Zaragoza was expecting to find a dark, thickened, and solid gallbladder in Patient J.C. Concluding that the structure he had located was the gallbladder, Dr. Zaragoza freed the organ of surrounding tissue, freeing away without incision adhesions to the organ, bringing the organ into position for removal. As Dr. Zaragoza began to free up the fat tissue around what he believed were the bile duct and blood vessels of the gallbladder, the organ ruptured, revealing a solid mass. Dr. Zaragoza believed that the mass was a tumor, which Dr. Zaragoza had encountered in other gallbladder surgeries. Dr. Zaragoza continued the procedure, separating the gallbladder for removal. While dividing what he believed was a cystic duct, Dr. Zaragoza encountered a bifurcation that did not correspond to the anatomy of the gallbladder. At this point, Dr. Zaragoza decided that surgery needed to be converted from laparoscopic to an open procedure. After doing so, a frozen section of the organ was sent to pathology for evaluation, in order to obtain a rapid evaluation of the tissue. The pathology report revealed that the organ that Dr. Zaragoza had removed from Patient J.C. was a healthy kidney. Dr. Zaragoza thereupon located the gallbladder by examining the dense adhesions around the colon, a risky procedure. Ultimately Dr. Zaragoza was required to cut into the transverse colon where he located the gallbladder, which had eroded into the transverse colon. Dr. Zaragoza then completed the surgical procedure, removing the gallbladder. Patient J.C.’s family was immediately advised of what had taken place; that Dr. Zaragoza had removed a kidney, in addition to successfully removing the gallbladder. The removal of a healthy kidney involves a medical procedure totally unrelated to removal of an unhealthy gallbladder. Removal of a healthy kidney is not a known or expected complication of gallbladder removal. Dr. Zaragoza’s removal of Patient J.C.’s kidney during gallbladder surgery constituted a “a wrong-site procedure, wrong procedure, or an unauthorized procedure, or a procedure that is medically unnecessary or otherwise unrelated to the patient’s diagnosis or medical condition.” The Department’s proposed findings of fact 12 through 20 contained in the Department’s Proposed Recommended Order, are accurate, support the ultimate findings of fact made in this paragraph and are subordinate thereto. Proposed findings of fact 36 through 38 of Respondent’s Proposed Order in large part accurately reflect the difficulty of the surgery performed on Patient J.C. Even the Department’s own expert noted that he thanked God Patient J.C. had not been his patient. The suggestion in paragraph 26 that the removal of the kidney was “simply an unwanted complication associated with this cholecystectomy procedure” is, however, not supported by the weight of the evidence.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered by the Board of Medicine finding that Bernard J. Zaragoza, M.D., has violated Section 456.072(1)(bb), Florida Statutes, as alleged in the Administrative Complaint; imposing a fine of $5,000.00; issuing a letter of concern; requiring the completion of five hours of risk management education; and requiring that he perform 50 hours of community service. DONE AND ENTERED this 6th day of April, 2010, in Tallahassee, Leon County, Florida. LARRY J. SARTIN 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 6th day of April, 2010. COPIES FURNISHED: Rolando A. Diaz, Esquire Kubicki & Draper 25 West Flagler Street, Penthouse Miami, Florida 33130 Robert A. Milne, Esquire Department of Health Prosecution Services Unit 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399 Diane K. Kiesling, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-3265 Dr. Ana M. Viamonte Ros, Secretary Department of Health 4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
Findings Of Fact The Respondent, Charles P. Shook, M.D., is a medical doctor having been issued license number 0020414, pursuant to Chapter 458, Florida Statutes. He is board certified in the areas of general and peripheral vascular surgery and practices in those specialty areas in Fort Myers, Lee County, Florida. He has been practicing in Lee County since 1973. The Petitioner is an agency of the State of Florida, charged with enforcing the licensure and practice standards embodied in Chapter 458, Florida Statutes and related statutes and rules and imposing disciplinary measures for departure from those standards by physicians licensed in Florida when such are proven. Mrs. Betty A. Fiore, at times pertinent hereto, was an obese, 47-year old female, with a history of thrombo-phlebitis and progressively enlarging and painful bilaterial varicosities of the veins in her right and left legs. She was admitted to Fort Myers Community Hospital on January 28, 1979, by the Respondent, for performance of a bilateral "vein-stripping" surgical procedure. Her medical history reflected that she had had a similar vein-stripping procedure performed over 20 years previously. The patient was operated on by the Respondent on January 29, 1979, beginning at approximately 9:25 a.m. The procedure was quite lengthy due to certain complications and lasted until 1:25 p.m. that day. After normal preparations, under general anesthesia, the Respondent began the operation by performing an oblique groin incision on the left leg just below the inquinal liagment, approximately ten centimeters in length. The incision penetrated the subcutaneous tissue and, as the "fossa-ovalis" was approached, the Respondent noted a significant amount of scar tissue, apparently related to the earlier surgical procedure, which obliterated and concealed much of the normal anatomy and structure in the area of surgery. It was of such a dense nature that only a faintly palpable pulse could be felt in the vessel. The Respondent dissected out the various venous branches in the area and individually ligated them. During his dissection process, the distal common femoral artery was injured by being slightly nicked with the surgical instrument. Repair procedures for the injury to the artery were carried out as will be described below. In any event, the "codman stripper" was employed in carrying out the stripping operation on the vein in question and additionally, several incisions were made around the calf of the leg to alleviate smaller varicosities. One large perforating vein in the malleolar area had to be ligated after the superficial portion had been stripped away. The Respondent then began to perform a similar procedure on the right leg, in spite of the initial difficulties he had had on the left leg, because he did not expect such severe scar tissue involvement with the anatomical structures in the area of incision on both legs. When he carried out the incision on the right leg however, he found that the anatomy of the right leg was essentially the same as that of the left and that substantial scar tissue reaction had occurred, related to prior surgery, with obliteration of much of the normal anatomy, including concealment of the femoral artery. Due in large part to these anatomical changes and complications involved in dissecting out the various venous branches involved in the stripping procedure, the right femoral artery was also slightly nicked by the scalpel. The Respondent attempted to suture the femoral arteries nicked in both legs at the time these injuries occurred, but the sutures would not hold in the arteries due to some then unknown, medical condition. After the same failure to hold sutures was encountered with regard to both femoral arteries, the Respondent sent samples of the arteries to the pathologist for evaluation. The pathologist report indicated that the arteries were "normal." Parenthetically it should he noted that the "complaining witness," Mrs. Fiore, has been found to exhibit symptoms of diabetes mellitus. Her testimony was somewhat evasive concerning the degree to which she may suffer from this malady, which can have a detrimental effect on the vascular system. In any event, when working first on the left leg, the Respondent elected to resect back along the artery for approximately a half-inch on each side of the wound and after that resection, to repair the femoral artery with the insertion of a 6 millimeter gortex graft. Likewise, with regard to the right leg, the Respondent found the sutures would not hold in the damaged artery (which was of a "cheese-like" consistency). He therefore performed a similar resection and insertion of a 6 millimeter gortex graft to repair the injury. The surgical procedure was then successfully concluded. Post-operatively the patient encountered some complications involving infection in the groin area, requiring two additional admissions to Fort Myers Community Hospital. Subsequently, she was transferred to Methodist Hospital in Houston, Texas, where she underwent two additional surgical procedures. The Petitioner presented the opinions of two expert witnesses, Dr. Alexander Braze and Dr. E. William Reiber. Dr. Braze's expert opinion is predicated on the review of Mrs. Fiore's office records from the Respondent's office, the hospital charts for her three admissions to Fort Myers Community Hospital, and summaries of her two admissions to the Methodist Hospital in Houston, Texas. His opinion is not based on any examination of the patient involved. Dr. Braze thus opined that because of the previous surgery on the greater saphenous vein, bilaterally, there would be obvious and considerable scarring and scar tissue in the subcutaneous area which would distort and conceal the individual anatomical structures. He himself has never nicked a femoral artery while doing a vein-stripping operation but, although he acknowledges it is an "uncommon complication, he has heard of it occurring. He was unable to render an opinion concerning whether or not the operation was performed properly because this was not a typical vein ligation and stripping procedure, due to the presence of extensive scar tissue, and resulting difficulty involved. The dense scar tissue precluded identification of the structures in the area of the surgical incision and meant that the Respondent had to proceed slowly and very meticulously with a careful dissection, deviation from which careful procedure could cause difficulty. The doctor's procedure was slow and meticulous. The procedure (for both legs) took approximately four hours. Although the Respondent proceeded with care, he nicked the arteries anyway. Dr. Braze could not state that such a complication, albeit uncommon, constituted a departure from standards normally recognized in the medical community. With regard to the doctor's judgmental decision to proceed to the right leg after nicking and repairing the artery in the left leg and completing the vein stripping procedure in the left leg. Dr. Braze opined that he was acting as a reasonable physician in proceeding to the other leg since he had already corrected the initial injury, especially since it was the leg in which she was having her chief complaints. In any event, Dr. Braze was unable to render an opinion as to whether or not the procedure up to the point of nicking the artery was properly or improperly done, although he acknowledged that the lengthy time taken to perform the total procedure indicates that the doctor was proceeding slowly and with greater than normal difficulties. In any event, after the arteries were nicked, the procedure followed by the Respondent was excellent and the repair work was competently and efficiently performed. Dr. Reiber, Petitioner's other expert witness, testified by deposition, which was stipulated into evidence. His expert opinion was based on a review of the deposition of the Respondent, the Fort Myers Community Hospital records of the patient, and the depositions of the patient, Betty Fiore, Arnold Flare and Quillen Jones. Additionally, he reviewed the records dealing with Mrs. Flare's treatment in Houston, Texas. He thus opined that the Respondent made two technical errors when he injured the arteries in each leg and he felt that it was an error in judgment to have performed the procedure on the right leg after having encountered difficulty in the initial procedure on the left leg. He was unable to opine however, that the treatment rendered the patient by Respondent fell below the appropriate standard of care accepted by similar physicians in the community. Moreover, he also opined that the Respondent's treatment after nicking the arteries affirmatively met the standard of care for reasonably prudent physicians in such circumstances. The expert witnesses presented on behalf of the Respondent were Drs. Peter M. Sidell and Luis A. Ruilova. Both witnesses opined, in effect, that, given the obesity of the patient and the difficult surgical process that alone entailed, coupled with the significant involvement of scar tissue in the area of the incision, that the complications associated with this procedure could occur in the hands of even the most renowned surgeon. The fact that the Respondent experienced these complications does not render his practice in this regard to be below the standard of care for vascular surgeons in that community or area of practice. They further opined that it is a matter of personal judgment on whether to proceed to the other leg after encountering these difficulties. A reasonable judgment would have been to explore the groin area on the other side, after accomplishing repair of the first injured artery, which was done. The initial arterial injury having been repaired in a successful manner, both of the Respondent's experts opined that, the patient then being stabilized, the Respondent was justified in proceeding to the other leg and performing the procedure on that side. The main purpose of the operation was to remove the veins of the patient since the patient was symptomatic with varicosities. It therefore would be poor judgment to simply repair the nicked artery and proceed no further, since the symptomatic vein would remain uncorrected. In short, both experts for Respondent opined that neither the vein-stripping procedure, the repair of the damaged arteries nor post-operative management for which Respondent was responsible were performed in a manner below the appropriate standard of care of reasonably prudent physicians in the community. Thus, although the patient unfortunately experienced difficulties during a procedure involving the accidental nicking of her femoral arteries and, after the grafts repairing those injured arteries were performed, later suffered an infection at the operative site necessitating further hospitalization, no expert witness could describe the treatment and care afforded this patient as being below the appropriate standard of care exercised by a reasonably prudent physician performing such vascular surgical practice in the Fort Myers community or area. The Respondent has never encountered this difficulty either before or since this occasion in his practice, which is characterized by frequent vascular surgical procedures. Additionally, Dr. Ruilova established that the nicking of the femoral arteries during such a procedure, although not a common occurrence, is well documented in the literature and not at all unheard of. Indeed, Dr. Ruilova, when assisting a distinguished surgeon who was chief of surgery at the Mayo Clinic at the time, observed that expert surgeon nick a femoral artery in a vein- stripping procedure on two occasions. Finally, it is noted that the Respondent's practice has been characterized by a high level of professional expertise, competence and compassion in caring for his patients, both before and since the occasion in question. He has never before been subjected to disciplinary action.
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence of record, the candor and demeanor of the witnesses and the pleadings and arguments of the parties, it is, therefore RECOMMENDED that a Final Order be entered by the Board of Medical Examiners dismissing the complaint in its entirety. DONE and ENTERED this 11th day of October, 1984, in Tallahassee, Florida. P. MICHAEL RUFF Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904)488-9675 FILED with the Clerk of the Division of Administrative Hearings this 11th day of October, 1984. COPIES FURNISHED: Barbara K. Hobbs, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301 Patrick Geraghty, Esquire HENDERSON, FRANKLIN, STARNES & HOLT Post Office Box 280 Fort Myers, Florida 33902 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
