The Issue The issue presented is whether Respondent is guilty of the allegations contained in the Administrative Complaint filed against him, and, if so, what disciplinary action should be taken against him, if any.
Findings Of Fact At all times material hereto, Respondent has been a physician licensed in the State of Florida and has been Board- certified in obstetrics and gynecology. On May 7, 1998, Patient A. J. underwent a laparoscopic procedure due to a complex left ovarian cyst at Columbia Surgical Park Center, an ambulatory care center located in Miami, Florida. The operation consisted of a laparoscopy with laparoscopic lysis of adhesions and a laparoscopic left ovarian cystectomy. Respondent performed the surgical procedure under general anesthesia. Gerald Kranis, M.D., was the anesthesiologist during the procedure. Respondent made a small vertical incision in the umbilicus and insufflated the abdomen with carbon dioxide gas. Respondent then entered the abdomen through a visiport with a 10-millimeter scope. He initially examined the upper abdomen. The patient’s liver and gall bladder appeared normal. Respondent next turned the laparoscope caudally. Inspection of the pelvic organs revealed numerous adhesions of the omentum and bowel to the anterior abdominal wall and to the uterus. Respondent took down the adhesions with sharp dissection with no bleeding. Respondent noted that there was adherence of the bowel to the anterior uterus. This was dissected away with sharp dissection. Inspection of the right adnexa showed a hemmoraghic cyst of the left ovary, and this was dissected by sharp dissection. In the process, the cyst ruptured extruding chocolate-appearing material. The cyst wall was grasped with an atraumatic grasper and teased out. Hemostasis was secure, and the cyst was retained to be sent to pathology. Inspection of the cul-de-sac revealed numerous adhesions of the bowel to the posterior uterus, and these were lysed with sharp dissection. At the end of the procedure, just before Respondent exited the abdomen, the patient’s blood pressure dropped. Inspection of the abdomen revealed no increased bleeding, but there was one area when viewed through the laparoscope that was suspicious of a hematoma. Respondent removed the laparoscope and placed a Foley catheter in the bladder. Respondent then performed a laparotomy, entering the abdomen through a Pfannenstiel incision. There were numerous adhesions of the bowel to the anterior abdominal wall, and Respondent lysed them with sharp dissection. Respondent then discovered a retroperitoneal hematoma. Respondent applied pressure on this area, and a vascular surgeon was summoned. Although the medical records do not specify that pressure was applied with a wet pad, the Department’s expert and Respondent’s expert interpret the description in the medical records to show that Respondent applied direct pressure with a wet pad. Upon his arrival, Manuel Torres-Salich, M.D., a vascular surgeon, assumed responsibility for managing the patient. He noted that the systolic pressure was 60 MMHG, and he extended the Pfannenstiel incision to a long midline vertical incision. Upon entering the abdominal cavity, he noticed a massive amount of blood throughout the abdominal cavity. However, he did not quantify the amount of blood he observed. Dr. Torres-Salich attempted the surgical repair of the patient’s vascular injuries. He discovered a large anterior laceration of the right proximal common iliac artery at the bifurcation of the aorta and a laceration of the anterior wall of the iliac vein. During the course of the surgical repairs, the patient experienced cardiac arrest, and CPR was administered while the vascular surgical repairs continued. As Dr. Torres-Salich continued to repair the vascular injuries, the patient experienced further cardiac complications. Cardiac massage and CPR were performed. The patient did not respond and expired. No evidence was offered as to the medical equipment available at Columbia Surgical Park Center. Specifically, no evidence was offered as to whether vascular clamps were available for use by Respondent, and, if available, whether these were the type of clamps appropriate for controlling a vascular injury of the iliac artery or iliac vein by a gynecologist. Further, no evidence was offered as to the types of medical personnel available at Columbia Surgical Park Center to assist Respondent other than anesthesia personnel. The record in this cause is clear, however, that a vascular surgeon was not in attendance at Columbia Surgical Park Center during patient A. J.’s procedure but was summoned on an emergency basis. The vascular surgeon arrived within about 20 to 25 minutes after the vascular emergency was discovered. The vascular lacerations that occurred to the iliac artery and iliac vein were lacerations to two of the largest blood vessels in the body. There is no evidence that any improper technique by Respondent during the laparoscopic procedure caused the lacerations of the iliac artery and iliac vein. The exact cause of these lacerations is not known. However, there are three possible causes: from insertion of the Voorhees needle, from insertion of the trocar, or from dissection of adhesions. A gynecologist who experiences a significant vascular injury, such as a laceration of an iliac artery, is trained to abandon the laparoscopic approach immediately, make an incision via laparotomy, and place direct pressure right on the area with a hand or pack. Respondent handled the laparoscopic complication appropriately by performing a laparotomy and applying direct pressure to the retroperitoneal hematoma. Respondent also handled the laparoscopic complication appropriately by calling for the emergency assistance of a vascular surgeon. General gynecologists are not trained to repair vascular injuries, and the immediate objective of a gynecologist once a vascular injury is identified is to do one of two things: apply direct pressure to the area of the bleed or try to clamp the vessel. Visualization of the specific vessel causing the bleed is required to properly use a clamp. Visualization of the specific blood vessels causing this patient’s retroperitoneal hematoma would require Respondent to perform a retroperitoneal dissection, which general gynecologists are not trained to perform. The standard of care in such a situation is for the gynecologist to summon a vascular surgeon. Further, if a gynecologist is not able to identify the exact point of injury, then direct pressure to the hematoma is sufficient and within the standard of care. There is no evidence that Respondent ever attended a gynecologic oncology fellowship where a general gynecologist would get additional training to be able to perform a retroperitoneal dissection. Respondent did not deviate from the standard of care by failing to perform a retroperitoneal dissection to visualize the specific blood vessels causing the hematoma. Respondent did not deviate from the prevailing standard of care by failing to apply pressure above the injury to stop the bleeding. Respondent’s application of pressure at the site of the hematoma was proper. Respondent did not fail to adequately prepare for and deal with a known complication of laparoscopy. He complied with the standard of care by stopping the laparoscopic approach, performing a laparotomy, applying pressure to the bleeding site, and immediately calling a vascular surgeon.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding Respondent not guilty of the allegations contained in the Administrative Complaint and dismissing the Administrative Complaint filed against him in this cause. DONE AND ENTERED this 28th day of March, 2001, in Tallahassee, Leon County, Florida. LINDA M. RIGOT 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 March, 2001. COPIES FURNISHED: Kim M. Kluck, Esquire Agency for Health Care Administration 2727 Mahan Drive Building Three, Suite 3431 Post Office Box 14229 Tallahassee, Florida 32317-4229 Mark A. Dresnick, Esquire Sean M. Ellsworth, Esquire Dresnick, Ellsworth & Felder, P.A. SunTrust Plaza, Suite 701 201 Alhambra Circle Coral Gables, Florida 33134 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Bin A02 Tallahassee, Florida 32399-1701 Theodore M. Henderson, Agency Clerk Department of Health 4052 Bald Cypress Way Bin A02 Tallahassee, Florida 32399-1701
The Issue The issues for determination in this proceeding are whether Respondent failed to practice medicine with that level of care, skill, and treatment of two patients which is recognized by a reasonably prudent similar physician as being acceptable under similar circumstances and whether Respondent failed to keep written medical records justifying the course of treatment of the two patients.
Findings Of Fact Petitioner is the state agency statutorily charged with the duty and responsibility for enforcing applicable statutes and administrative rules against physicians licensed by the State of Florida. Respondent is, and has been at all times material hereto, a physician licensed by the state, having been issued license number ME 0032342. Patient A.R. Patient A.R. is an elderly female who was approximately 80 years old when Respondent first examined her on January 8, 1987. Patient's chief complaint was a 10 year history of hypertension. Respondent diagnosed patient A.R. as suffering from hypertension and possible angina pectoris. The patient was using a pacemaker at the time she first saw Respondent. Respondent performed an EKG on patient A.R. on January 8, 1987, and determined that the patient's pacemaker was malfunctioning. Respondent performed an EKG on patient A.R. on June 14, 1987. Respondent misinterpreted the EKG as indicating that patient A.R. had a sinus rhythm, frequent ventricular premature complexes, marked rhythm irregularity, and a heart rate of 65 beats per minute. Respondent noted his diagnosis in patient A.R.'s chart. The EKG actually indicated that patient A.R. was suffering from a second degree heart block and that her heart rate was below 50 beats per minute. A second degree heart block is a condition in which the area in the heart which initiates the heart beat functions abnormally. In effect, the electricity is blocked from going into the heart and starting the heart beat. The patient's pulse rate is lower than it should be. Patient A.R. was suffering from a second degree heart block on June 14, 1987, and was not properly diagnosed by Respondent. 1/ Patient A.R. went to a hospital emergency room on June 19, 1987, with a very low pulse rate. She was admitted to the hospital and had a permanent pacemaker implanted. The standard treatment for a heart block is a pacemaker. There may be insufficient blood supplied to the brain of a patient who suffers from a heart block. If left untreated, a patient may experience fainting, cardiac arrhythmia, and death. Respondent failed to practice medicine with that level of care, skill and treatment of patient A.R. which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. After examining patient A.R. on June 14, 1987, and on June 16, 1987, Respondent failed to correctly interpret the EKG results on June 14, 1987, and failed to properly diagnose patient A.R. The written medical records that Respondent maintained on patient A.R. failed to justify the course of treatment for patient A.R. The records contained an incorrect reading of the EKG given on June 14, 1987, and failed to justify the course of treatment followed for patient A.R. Patient C. H. Patient C. H. is an elderly female who was 65 years old when she was first seen by Respondent on October 23, 1985. Respondent noted that patient C.H. had occasional rectal bleeding and chronic anemia. Respondent noted in the medical records that patient C.H. should have a rectum and colon study performed. However, no tests were ever conducted to determine the source of bleeding or to test the patient's stool for blood. On April 7, 1987, patient C.H. was examined by Respondent complaining of anal bleeding for 2 or 3 days. Her hemoglobin count was markedly low. On May 7, 1987, patient C.H. was examined by Respondent and stated that her anal bleeding decreased four days after her office visit on April 7th. On August 3, 1987, patient C.H. was hospitalized and found to be anemic. Respondent failed to practice medicine with that level of care, skill and treatment of patient C.H. which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. Respondent failed to perform any diagnostic tests or studies on patient C.H. between October 23, 1985, and August 3, 1987, to determine the source of her anal bleeding or to test her stool for blood. Respondent also failed to refer patient C.H. to a specialist for a gastrointestinal work-up. The written medical records that Respondent maintained on patient C.H. failed to justify the course of treatment for patient C.H. The records failed to include a justification for the course of treatment, the failure to conduct tests, or the failure to refer the patient to a specialist.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a Final Order finding that Respondent is guilty of violating Sections 458.331(1)(m) and (t), Florida Statutes, imposing an administrative fine of $3,000 against Respondent, and placing Respondent on probation for two years subject to such reasonable terms and conditions as the Board may impose. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 9th day of September, 1991. DANIEL MANRY 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 10th day of September, 1991.
The Issue The issue is whether Respondent is guilty of failing to practice in accordance with the applicable standard of care or failing to keep adequate medical records and, if so, what penalty should be imposed.
Findings Of Fact At all material times, Respondent has been a licensed physician, holding license number ME 44240. He has been licensed in Florida since 1984. Respondent has practiced plastic surgery, particularly cosmetic plastic surgery, for the past 22 years. Respondent is certified by the American Board of Plastic Surgery in plastic surgery. He was also certified in Advanced Cardiac Life Support (ACLS) at the time of the surgery in question. The Board of Medicine previously disciplined Respondent by Final Order filed September 1, 1995, pursuant to a Consent Agreement into which the parties had entered. The Consent Agreement arose from allegations that Respondent had failed to remove a sponge from a breast during breast augmentation surgery. Respondent did not admit the allegations, but agreed to pay a $2000 fine and attend ten hours of continuing medical education. The Administrative Law Judge admitted this evidence strictly for the purpose of penalty, not liability. Respondent performs plastic surgery at the Cosmetic Surgery Center in Fort Lauderdale. The 5000 square-foot facility contains three examination rooms, two operating rooms, one recovery room, and an overnight hospital. Another physician also operates at the Cosmetic Surgery Center, which employs a wide range of staff, including a patient coordinator, nurse practitioner, and a certified register nurse anesthesiologist (CRNA). In the past, the Cosmetic Surgery Center retained a CRNA to assist in surgery on an as-needed basis. However, since mid-2005, the Cosmetic Surgery Center has regularly employed a CRNA after the Board of Medicine issued an Order of Emergency Restriction of License on June 8, 2005. Issued in response to the incident described below, the emergency order requires, among other things, that Respondent employ a CRNA or M.D. anesthesiologist to administer anesthesia at all surgeries, unless the surgery will involve Level I sedation. The emergency order also requires Respondent to obtain an unqualified surgical clearance from every patient's primary care physician. Respondent has performed over 10,000 procedures using Level II sedation over 25 years. Level II sedation leaves the patient conscious, but tranquil, and responsive to painful stimulus or verbal command. Level III sedation leaves the patient unconscious. This case involves a 50-year-old female, S. B., who presented to Respondent's office on July 9, 2003, to discuss the possibility of an abdominoplasty, breast augmentation, and arm lift. Respondent had previously performed an abdominoplasty, which is also known as a tummy tuck, on S. B.'s daughter, who wanted to make a present of cosmetic surgery for her mother. After examining S. B., Respondent recommended against any work on the arms, as the surgical scars would outweigh the benefits of the surgery for S. B. During this initial office visit, Respondent took a history from S. B., who had three children and was employed as a receptionist for a local roofing company. S. B. stated that her general health was good, and she had never had significant complications from any surgery. She reported that her only medical problem was hypertension and that she consequently took clonidine and Lasix. She stated that she had never reacted badly to general or local anesthesia, did not bruise easily, and did not bleed excessively from cuts. The form asked the patient to list intoxicating or mind-altering drugs, and S. B. did not list any. At no time during the July 9 visit did S. B. express an intent to proceed with the surgery, and, in fact, she was undecided at the time and remained so for several months. Respondent next saw S. B. on December 11, 2003, when she presented at his office for a pre-operative examination. Respondent again discussed the surgical procedures. During this visit, S. B.'s blood pressure was 210/112, which was too high for Respondent to perform elective surgery. Instead, he discussed with S. B. the need to control her blood pressure and learned that she had quit taking her blood pressure medication. Respondent told S. B. to see her primary care physician to control the blood pressure. Respondent's notes document S. B.'s blood pressure, the referral, and the purpose of the referral. In anticipation of surgery on December 23, 2003, Respondent prescribed on December 11, 2003, fifteen 500-mg tablets of Duricef, fifteen 10-mg tablets of Lorcet, and fifteen 30-mg tablets of Restoril. Duricef is an antibiotic. An analgesic, Lorcet combines 10 mg of hydrocodone, an opioid, with acetaminophen. Restoril, or temazepam, is a sedative in the benzodiazepine family and is similar to Valium. Respondent typically prescribes these or similar medications, so that his patients can fill them prior to surgery and take them following surgery. On December 11, 2003, Respondent also ordered pre- surgical lab work. The lab report, dated December 12, 2003, states that S. B.'s values were largely normal. However, S. B.'s prothrombin time (PT), which measures clotting time, was very slightly elevated. The normal range for this parameter for this laboratory is 11-13 seconds, and the PT for S. B. was 14.8 seconds. However, the International Normalization Ratio (INR), which normalizes results among labs and tissue samples, was 1.4, which is within the normal range, as was the partial thromboplastin time (PTT), which is another measure of clotting time. S. B.'s red blood cell count was very slightly high (6.13 as compared to a range of 4.2-6.1 units per liter). Also very slightly low were S. B.'s M.C.V. (79.0 as compared to a range of 80.0-99.0 units), M.C.H. (26.3 as compared to a range of 27.0-31.0 units), and M.C.H.C (32.7 as compared to a range of 33.0-37.0 units per liter). Very slightly high was S. B.'s R.D.W. (15.4 as compared to a range of 11.5-15.0 percent). Except for the red blood cell count, the other parameters pertain to precursors of cells. The next day, Respondent added to the pre-operative prescriptions two 5-mg tablets of Mephyton, which is vitamin K. The medical records contain no discussion of why Respondent added vitamin K the day after he had ordered the other pre- operative medications. Most likely, this information would have been contained in Respondent's notes, which are in a handwritten scrawl that is partly illegible. Clearly, though, Respondent's notes fail to disclose the purpose of ordering Respondent to take vitamin K. Respondent testified that he was responding to the PT value, explaining that he gives vitamin K to patients with borderline clotting studies, so that the patients will not experience as much bruising and swelling. More important than the records' failure to contain an explanation for the ordering of vitamin K is their failure to address the high PT value in Respondent's plan of treatment for S. B. Even if only borderline high and more suggestive of problems involving only bruising and swelling, the PT raised a clotting issue, which is of obvious importance given the nature of the contemplated surgery. Respondent's records must address this issue and the impact, if any, on the contemplated surgery. In retrospect, the PT abnormality proved irrelevant. S. B. did not display any clotting problems or excessive bleeding during the surgery. At the hearing, Respondent explained the limitations of a PT value, especially when it is unaccompanied by an abnormal INR, although Respondent obviously thought enough of the PT test to order one for S. B. More cogent is Respondent's explanation at the hearing that the absence of any reported history of bleeding or bruising outweighed any concerns raised by a slightly elevated PT value, but this persuasive analysis is nowhere to be found in the medical records. Petitioner argues alternatively, though, that the slightly elevated PT value should have alerted Respondent to cirrhosis, which is discussed in more detail below. At the pre- operative stage, at least, the history, findings, and complaints did not support a diagnosis of cirrhosis. In his pre-operative physical examination, Respondent found no evidence of jaundice or edema. S. B.'s anemia had resolved. Her history lacked any indication of liver disease, nor did S. B. complain of any symptoms consistent with cirrhosis. These facts, as well as the information supplied by S. B.'s primary care physician, justified Respondent's failure to explore the possibility of liver disease prior to proceeding with surgery. Nor did the circumstances impose a duty on Respondent to include in the medical records a plan of treatment that addressed the possibility of cirrhosis. The facts reasonably known to Respondent did not raise the possibility of cirrhosis, any more than they raised the possibility of heroin use by S. B. It is thus irrelevant to Respondent's documentation duties, although not necessarily to her death approximately 30 hours after the end of the surgery, that S. B. suffered from some degree of cirrhosis and used heroin. On December 31, 2003, S. B.'s primary care physician completed a "Medical Clearance" form, even though Respondent had not requested a medical clearance, but had required only that the physician do what was necessary to get S. B.'s blood pressure under control. On the form, S. B.'s primary care physician noted that S. B.'s past history consisted of hypertension and, in June 2000, anemia. The addition of the date implied that S. B. no longer suffered from anemia--a fact borne out by her elevated red blood cell count. On the form, the primary care physician noted that her blood pressure was 160/98 and pulse was 80, changed one of S. B.'s blood pressure medications, and cleared her for surgery under local and general anesthesia, "once BP < 150/90." Two items on the Medical Clearance form support Respondent's decision not to investigate the possibility of liver disease before performing surgery. First, as noted above, the form indicates that S. B.'s anemia had resolved. It would be reasonable to assume that S. B.'s primary care physician was especially attentive to indicators of anemia or liver disease given this history. Second, the Medical Clearance indicates that S. B.'s primary care physician had ordered a comprehensive metabolic panel, which would include tests of liver function. The absence of any further contact from the primary care physician implies that the comprehensive metabolic panel revealed nothing of importance as to liver function, and the function of the liver is obviously important--not its post- mortem condition. On January 15, 2004, S. B. presented at the Cosmetic Surgery Center for an abdominoplasty with liposuction to the waist area. Respondent's scrawled notes do not disclose why he or S. B. decided not to proceed with the breast augmentation. In the pre-operative evaluation, which is initialed by Respondent, S. B.'s pulse was 95, and her blood pressure was 162/96, with the notation that she was nervous. Her rating on the American Society of Anesthesiologists (ASA) scale is I, meaning that she has no disease. Respondent concedes that her hypertension warranted a II, which means some systemic disease, but not threatening. However, the mis-rating on the ASA scale is irrelevant because it did not impact her treatment or outcome. The pre-operative evaluation contains two other notations of interest. First, Respondent planned for S. B. to remain overnight at the Cosmetic Surgery Center, rather than to discharge her to home on the day of the surgery or transfer her to a hospital. Thus, her remaining at the facility the night of the surgery did not suggest an unusually difficult surgery or recovery. Second, Respondent found S. B. fit for surgery under I.V. sedation in the office, rather than local or general anesthesia. Obviously, the pre-operative evaluation reports a blood pressure in excess of the maximum listed in the medical clearance that Respondent had received from S. B.'s primary care physician. Respondent's medical records fail to address this discrepancy and the broader issue of S. B.'s blood pressure, which was about the same as it was when she visited her primary care physician, but considerably lower than when she last visited Respondent. Respondent could and did reasonably exercise his own medical judgment and proceed with surgery despite a blood pressure in excess of the maximum on the medical clearance, but given this recommendation, S. B.'s extremely elevated blood pressure a month earlier, the challenges of maintaining reasonable blood pressure levels intra- and post- operatively, and S. B.'s hypertensive condition, Respondent was required to document his reasoning for proceeding with surgery despite the relatively high blood pressure. At hearing, Respondent offered a persuasive explanation of why he proceeded to perform the surgery despite a blood pressure reading over 150/90. Attributing the elevated blood pressure (and pulse) to adrenalin-producing anxiety, not hypertension, Respondent decided that he would be able to control S. B.'s blood pressure adequately during surgery with sedatives and blood pressure medication. Considerable evidence indicates that S. B. was a very nervous patient. S. B.'s pulse was also quite rapid on both visits. As was the case with the PT value, it is easier to credit Respondent's reasoning given hindsight, as he successfully controlled S. B.'s blood pressure during surgery. During surgery, Respondent's nurse practitioner, Michelle Huff, monitored heart function by an EKG, blood oxygenation and pulse by a disposable pulse oximeter, blood pressure, and respiration. During the surgery, Respondent was also assisted by Tiffany Archilla, a certified surgical technologist. At Respondent's direction and under his supervision, Nurse Hoff, administered the following drugs immediately before and during surgery: Diprivan, which is an anesthetic whose specific effect depends on rate of administration; Versed, which is a sedative; Robinul, which controls nausea; Ancef, which is an antibiotic; fentanyl, which is an analgesic and anesthetic; and labetalol, which controls blood pressure. Nurse Huff also administered oxygen and nitrous oxide, which is an anesthetic. Nurse Huff had been working at the Cosmetic Surgery Center for only two months at the time of S. B.'s surgery. Nurse Huff is not a CRNA, but is an advanced registered nurse practitioner and has been a registered nurse for 14 years. At the time of the hearing, she had been employed for three years at the Cosmetic Surgery Center, where she also had completed an internship. She estimates that she has participated in over 1000 surgical procedures involving Level II sedation. At 8:40 a.m., Nurse Huff administered 2.5 mg of Versed, 0.2 mg of Robinul, and 1.0 g of Ancef. At 8:45 a.m., Nurse Huff started the oxygen, nitrous oxide, and Diprivan drip. The oxygen was in a two-liter bottle, and the nitrous oxide was in a four-liter bottle. The Diprivan was 500 mg in a 500 cc solution. During the surgery, Nurse Huff administered all of this Diprivan, as well as all of another 200 mg of Diprivan in a 250 cc solution, given S. B.'s resistance to sedation. In most cases, and probably in this one, Respondent uses a microchamber, which releases microdrips at the rate of 60 drops per minute. Respondent does not administer Diprivan by means of an infusion pump, which would offer more precise control of the rate of infusion. The records do not indicate the rate of administration of the Diprivan. However, Respondent rarely finds it necessary to discontinue Diprivan during surgery, and its clinical effect wears off after only about three minutes following its discontinuation, so the patient arouses quickly after Diprivan is stopped. Thus, the failure to record the rate of administration of the Diprivan is immaterial. At 8:45 a.m., Nurse Huff also administered 100 mg of fentanyl, which was followed by 50 mg doses at 8:50 a.m., 8:55 a.m., 9:05 a.m., 9:35 a.m., 9:45 a.m., 10:05 a.m., and 10:10 a.m. S. B. thus received a total of 450 mg of fentanyl. The surgery commenced at 9:30 a.m. At the start of surgery, Respondent administered subcutaneously at the surgical site 150 cc of one percent lidocaine, which is a local anesthetic, with epinephrine at 1/200,000. The epinephrine prevents the body from quickly absorbing the lidocaine. S. B.'s blood pressure had varied between 8:40 a.m. and 9:30 a.m. It started at 164/97, but was 135/85 15 minutes later. Her blood pressure remained at 145/85 from 9:00 a.m. to 9:10 a.m. At the time of surgery, S. B.'s blood pressure was 162/88. In response to the start of surgery and reflective of S. B.'s level of anxiety, her blood pressure surged to 180/95 at 9:45 a.m., and Respondent directed Nurse Huff to administer 2.5 mg of labetalol at this time. S. B.'s blood pressure reached 190/80 at 10:00 a.m., five minutes after Nurse Huff had administered another 2.5 mg of labetalol. By 10:10 a.m., S. B.'s blood pressure was down to 125/75, where it remained for the remainder of the surgery. S. B.'s other vitals remained good during the surgery. Oxygenation saturation remained over 96 percent, mostly 97 and 98 percent. Respiration remained around 18. Pulse ran in proportion to blood pressure, but settled within the range of 80-90 once S. B.'s blood pressure stabilized at 10:10 a.m. Blood loss was minimal during the surgery. Typically, a patient may lose 200-300 cc of blood, but S. B. lost only 150 cc. Proceeding conservatively, Respondent did not try to tighten the muscle wall, as he found, once he had made the incisions, that S. B. did not require this procedure. The liposuction removed 200 cc, including 150 cc of fat. Anesthesia ended at 11:05 a.m., and surgery ended at 11:10 a.m. During the surgery, S. B. had received 2000 cc of fluids. At all times, S. B. remained active and alert. Evidencing S. B.'s level of alertness during surgery was her high oxygen levels at all times during surgery and the necessity of additional Diprivan. At 11:20 a.m., S. B. was transported by stretcher from the operating room to the recovery room. At this time, her oxygen level was 98 percent, her blood pressure was 179/97, her pulse was 96, and her respiration was 16. At 11:30 a.m., S. B. received 2.5 mg of labetalol. At 11:35 a.m., S. B. was complaining of anxiety, so she received 2.5 mg of Valium. At 11:40 a.m., a nurse emptied her Foley catheter of 1600 cc of clear yellow urine. At this time, S. B.'s blood pressure was 184/105, her pulse was 95, her respiration was 16, and her oxygen level was 96 percent. She received another 2.5 mg of labetalol. At 11:45 a.m., S. B. received another 2.5 mg of Valium. At 12:15 p.m., S. B.'s blood pressure was 164/92, and she received clonidine 0.1 mg to reduce her blood pressure. Fifteen minutes later, S. B.'s blood pressure dropped to 143/88. She fell asleep at 1:00 p.m., but awoke an hour later, complaining of pain. She then received 75 mg of Demerol with 6.25 mg of Phenergan, which controls nausea. At 2:30 p.m., S. B. complained again of pain. Her blood pressure had risen to 189/78, so she received another clonidine 0.1 mg. Fifteen minutes later, a nurse emptied S. B.'s Foley catheter of 1400 cc of clear urine. S. B.'s blood pressure was 170/100, and the nurse notified Respondent of this reading. The nurse gave S. B. 10 mg of Procardia, which reduces high blood pressure. At 3:00 p.m., S. B. received 2.5 mg of labetalol and 2.5 mg of Versed. Fifteen minutes later, S. B. was transferred by stretcher to the overnight room with a blood pressure of 141/60, pulse of 96, and respiration of 16. By 3:45 p.m., S. B.'s blood pressure was 125/59, and she was asleep. Thirty minutes later, S. B. was watching television, and her blood pressure was 141/78. After complaining of pain, S. B. received 100 mg of Demerol with 12.5 mg of Phenergan at 4:50 p.m. At 5:10 p.m., S. B.'s blood pressure rose to 163/94, and her pulse was 108. She received another 10 mg of Procardia at this time. At 6:00 p.m., S. B.'s blood pressure was down to 142/88. Two hours later, after she complained of insomnia, S. B. received 30 mg of Restoril. At 9:15 p.m., S. B. complained of abdominal pain. She received 100 mg of Demerol and 25 mg of Phenergan. At 11:30 p.m., S. B. received 30 mg of Restoril for insomnia and 10 mg of Lorcet for pain. At 1:20 a.m. on January 16, S. B. was sleepy. Two hours later, her blood pressure was 148/70. At 5:30 a.m., after an uneventful night, S. B. complained of abdominal pain and received another 10 mg of Lorcet. At 7:00 a.m., her intravenous line was discontinued. Alert and oriented, S. B. walked in the hall and received another clonidine 0.1 mg. A nurse emptied her Foley catheter of 400 cc of urine and removed the Foley catheter. At discharge at 8:00 a.m., Respondent examined the wound and found no evidence of bleeding, as he changed the dressing. At this time, S. B.'s blood pressure was 147/70 and pulse was 108. S. B. was transported by wheelchair to her daughter's car. S. B. and her daughter arrived at S. B.'s home at about 9:00 a.m. on January 16, 2004. After spending the morning with her mother, the daughter left the home and returned at 1:00 p.m. Having forgotten the house key, the daughter knocked on the door, and S. B. had to crawl to the door due to her lack of strength. The daughter assisted her mother to bed. Mid- afternoon, the daughter left her mother to run some errands. When the daughter returned home shortly before 6:00 p.m., she found her mother unresponsive and curled into a fetal position on the floor with blood present on the bed sheets and nightshirt that she was wearing. The daughter immediately called 911 and requested an ambulance. The emergency management technicians (EMTs) arrived at S. B.'s home at 6:23 p.m. and found her as her daughter had found her. S. B. was in full cardiac arrest. The EMTs found S. B. cold to the touch with fixed and dilated pupils. They found a "small amount" of blood oozing from the staples in the lower stomach. The two surgical drains in the upper stomach contained no discharge. Blood had soaked the bandage and run down both legs to thigh level. The EMTs estimated blood loss at about 500 cc. The EMTs also found the Restoril and Lorcet in the doses that Respondent had prescribed pre-operatively. The EMTs attempted unsuccessfully to resuscitate S. B. and transported her to the hospital where she was pronounced dead on arrival at 6:35 p.m. The medical examiner conducted an autopsy on January 17, 2004, at which time blood and urine samples were taken for toxicological analysis. The toxicology report notes that a gas chromatography/mass spectrometry procedure revealed the presence of 6-MAM, which is a metabolite of heroin and demonstrates conclusively that S. B. consumed heroin or, much less likely, 6-MAM; morphine, which is another indicator of heroin, at a concentration of 0.22mg/L; methadone at a concentration of less than 0.05 mg/L; meperidine, which is Demerol (a narcotic analgesic) at a near-toxic concentration of 0.98 mg/L; diazepam, which is Valium, at a concentration of less than 0.05 mg/L; nordiazepam, which is a metabolite of Valium, at a concentration of less than 0.05 mg/L; temazepam, which is, as noted above, Restoril or another metabolite of diazepam, at a concentration of 0.29 mg/L; and hydrocodone, which is one of the two ingredients, as noted above, of Lorcet, at a concentration of 0.05 mg/L. A drug's half-life is the amount of time for its potency to be reduced by half. Three to four half-lives are required for the complete elimination of a drug. Because various conditions can affect the half-lives of drugs, such as liver disease as to drugs eliminated substantially through metabolism by the liver, half-lives are stated as average ranges. Relevant half-lives are: Demerol--2-24 hours; diazepam--21-37 hours; hydrocodone--3.4-8.8 hours; and temazepam--3-13 hours. Diprivan and fentanyl have very short half-lives and were not detected by the toxicologist. The half- life of 6-MAM is also very short, about 6-25 minutes, leading the toxicologist who performed the report for the medical examiner to testify that S. B. had consumed heroin not more than two hours before her death. The same toxicologist testified that the detected concentration of Demerol was six times the therapeutic level. (This testimony is credited over the testimony of the Deputy Chief Medical Examiner that the concentration of 0.98 mg/L is only twice the therapeutic level.) Given a half-life of 2-24 hours, all that can be said with certainty is that S. B. suffered even greater concentrations of Demerol--possibly much greater--prior to the near-toxic concentration found by the toxicologist. Undoubtedly, the heroin and methadone that S. B. consumed were not prescribed by Respondent. Undoubtedly, S. B. had access to Demerol that Respondent had not administered. Respondent could not have reasonably have anticipated, based on the circumstances, that S. B. would consume heroin, methadone, and toxic or near-toxic amounts of Demerol, in addition to her prescribed medications, within 12 hours of her release from the Cosmetic Surgery Center. Just as an illegal drug user has the right to treatment in accordance with the applicable standard of care, so a physician has a right to expect behavior on the part of his patient that is at least consistent with the instinct of self-preservation. The autopsy determined that S. B. died of a combined drug overdose of heroin, temazepam, Valium, methadone, Demerol, and hydrocodone. Contributing causes of death were hypertension, abdominal wall hemorrhage, and cirrhosis. As to the hypertension, the autopsy report states that S. B. suffered from mild arteriosclerotic cardiovascular disease. As to the abdominal wall hemorrhage, the autopsy report states that S. B. was in status--post-tummy tuck and liposuction. As to the cirrhosis, the autopsy report states that S. B. suffered from severe fatty metamorphosis of the liver. The autopsy report concludes that the manner of death was an accident. Of the drugs that combined to kill S. B., Respondent clearly did not administer or prescribe the heroin or methadone. Although Respondent administered Demerol at the dosages of 75 mg at 2:00 p.m. 100 mg at 4:50 p.m., and 100 mg at 9:15 p.m., all on January 15, the near-toxic Demerol found in S. B. at the time of her death was not due to these doses, but due, at least in large part, to Demerol that S. B. obtained from other sources. The hydrocodone and temazepam were probably derived, at least in part, from the Lorcet and Restoril that Respondent prescribed for post-operative use. Unfortunately, the record does not reveal how many pills of each that the EMTs found at the S. B.'s home, so it is impossible even to infer how much of each medication that S. B. took while at home during the afternoon of January 16 immediately preceding her death. Not much hydrocodone was found in S. B., and the 10 mg of Lorcet given at 11:30 p.m. on January 15 and 10 mg of Lorcet given at 5:30 a.m. on January 16 would have been nearly eliminated by the time of S. B.'s death, given the short half-life of hydrocodone. Considerably more temazepam was found in S. B., but the 30 mg of Restoril given at 8:00 p.m. and 30 mg of Restoril given at 11:30 p.m. would have been nearly eliminated by the time of S. B.'s death, given the short half-life of temazepam. Clearly, in the two or three hours before she died, S. B. took heroin, methadone, and Demerol. Clearly, the fentanyl that she had last received at 10:10 a.m. on the prior day and the Diprivan that she had last received at 11:05 a.m. on the prior day had long cleared her system before she took the heroin, methadone, and Demerol. S. B. accidentally took her own life by taking these three drugs. The record does not suggest that hemorrhaging from the surgical site was due to some failure on Respondent's part. Instead, it appears more likely that falling from the bed or possibly convulsing from the drug overdose, S. B. may have reopened the incision site. The record does not suggest that cirrhosis materially extended the half-lives of any medications that Respondent administered. S. B. efficiently eliminated the Valium that Respondent administered. The record does not explain why she would not as efficiently eliminate other drugs metabolized primarily by the liver. The record does not suggest that Respondent's management of S. B.'s hypertension intra- and post-operatively had any bearing on her demise. Her blood pressure stabilized late in the afternoon of January 15, and nothing in the record suggests that anything that transpired on that day concerning S. B.'s hypertension caused an acute crisis that resulted in her death. As to Count I, Respondent did not depart from the applicable standard of care. S. B. never fell below Level II sedation; she was always responsive to pain and attempts to communicate. S. B. proved difficult to sedate even to Level II. On these facts, it is impossible to find even that it was reasonably likely, at the outset of the procedure, that S. B. would reach Level III sedation. Additionally, as to Count I, Respondent competently managed S. B.'s hypertension intra- and post-operatively. Based on the circumstances, Respondent correctly determined that the slight elevation of PT would not interfere with clotting or endanger the patient's safety and correctly determined that the other five slight abnormalities in the lab report were immaterial to patient safety in the contemplated surgical procedure. Respondent was thus not required to obtain additional tests or to obtain a consultation for the slight PT abnormality. Based on the physical examination and lab results, including those ordered by the primary care physician, insufficient evidence of liver abnormality existed to preclude the administration of the acetaminophen contained in Lorcet. Further, the standard of care does not preclude the prescription of acetaminophen to all patients with any kind of liver disease. As to Count II, Respondent's medical records fail to document adequately why he proceeded to operate despite S. B.'s failure, pre-operatively, to reach a blood pressure of less than 150/90, why he administered vitamin K pre-operatively, and, most importantly, how he had assimilated the PT abnormality in his treatment plan for S. B. As noted above, at hearing, Respondent amply supplied all of this information--the problem is that he never bothered to do so in the medical records. Although these deficiencies in medical records did not contribute in any way to S. B.'s death, they are material failures to justify the course of treatment. In contrast to the detailed records of Nurse Huff intra-operatively and the post-operative records prepared by nurses, Respondent's notes, and thus the records themselves, do not approach the minimum level of detail necessary to justify the course of treatment in this case. As to Count III, Respondent did not administer or cause to be administered excessive or inappropriate quantities of Diprivan. As to Count IV, Respondent did not improperly delegate professional duties, with respect to the administration of Diprivan, to a registered nurse who was not a CRNA. At all times, Respondent adequately supervised and monitored the administration of this short-acting sedative. The record does not support Respondent's claim of prejudice resulting from any delay in the prosecution of this case. Any claim of prejudice due to delay is undermined by Respondent's failure to demand an immediate hearing due to the imposition of an emergency restriction on his license.
Recommendation It is RECOMMENDED that the Board of Medicine enter a Final Order dismissing Counts I, III, and IV of the Administrative Complaint, finding Respondent guilty of a single violation of Section 458.331(1)(m), Florida Statutes, suspending his license for 30 days, placing his license on probation for two years, requiring him to complete successfully continuing medical education on medical records, and imposing an administrative fine of $10,000. DONE AND ENTERED this 25th day of August, 2006, in Tallahassee, Leon County, Florida. S 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 25th day of August, 2006. COPIES FURNISHED: Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, BIN A02 Tallahassee, Florida 32399-1701 Timothy M. Cerio, General Counsel Department of Health 4052 Bald Cypress Way, Bin AO2 Tallahassee, Florida 32399-1701 John E. Terrel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Lewis W. Harper Brew and Harper, PL 6817 Southpoint Parkway, Suite 1804 Jacksonville, Florida 32216 George Kellen Brew Brew and Harper, P.L. 6817 Southpoint Parkway, Suite 1804 Jacksonville, Florida 32216 Patricia Nelson Department of Health 4052 Bald Cypress Way, Bin C65 Tallahassee, Florida 32399
The Issue The issue to be resolved in this proceeding concerns whether Respondent's license to practice medicine should be subject to sanctions based upon alleged violations of Section 458.331(1)(m) and 458.331(1)(t), Florida Statutes. Specifically, it must be determined whether he departed from the appropriate standard of medical care and treatment of a patient in the course of his practice of ophthalmology and whether his record keeping with regard to the care and treatment of that patient met appropriate standards.
Findings Of Fact Stipulated Facts The Petitioner is the state agency charged with regulating the practice of medicine, pursuant to Section 20.30, Florida Statutes, and Chapter 455, Florida Statutes. The Respondent is, and at all times material hereto, has been a licensed medical doctor in the State of Florida, having been issued license number ME0004933. The Respondent's address is 820 Prudential Drive, Suite 712, Jacksonville, Florida. On or about September 13, 1989, patient D.P., a 65-year-old-female, presented to the Respondent for evaluation regarding extremely high intra-ocular pressure and severe pain in both eyes. Patient D.P. had undergone abdominal surgery two days prior to the Respondent's examination, which was her second abdominal surgery in two weeks. The Respondent examined patient D.P. and diagnosed her with acute angle closure glaucoma, which had been present since the time of her second abdominal surgery, two days earlier. The Respondent treated patient D.P. with topical medications to decrease the intra-ocular pressure. Patient D.P.'s left eye responded to treatment with decreased pressure. The intra-ocular pressure in the right eye remained extremely high, in excess of 70 millimeters. On or about September 13, 1989, the Respondent performed a vitreous tap of the patient D.P.'s right eye, which immediately relieved the intra-ocular pressure. The Respondent did not consult patient D.P.'s surgeons or internists prior to performing the vitreous tap, regarding the possible use of intravenous medications. On or about September 14, 1989, the Respondent consulted Dr. James Staman, a retinal specialist, due to the patient's diminished vision in her right eye. Dr. Staman examined patient D.P. and diagnosed her with a vitreous hemorrhage. (End of stipulated facts). The Respondent has been licensed to practice medicine in the State of Florida since 1954 and has practiced in the field of ophthalmology since 1966. He has been board certified in the field of ophthalmology since 1969. He has never been investigated or disciplined by the Department of Business and Professional Regulation or any predecessor agency charged with regulating the licensure and practice standards of medical doctors in Florida. The Respondent maintains hospital staff privileges appropriate to his practice and has never had hospital staff privileges denied, revoked, or suspended at any hospital at which he has had privileges. Patient D.P. is a 65-year-old-female, who presented to the Respondent on September 13, 1989 complaining of severe pain in both eyes and with regard to which the Respondent immediately determined the presence of extremely intra- ocular pressure in both eyes. Patient D.P. had recently undergone a gastrectomy, a major abdominal surgical procedure, within 48 hours prior to presenting to the Respondent. This was the second abdominal surgery she had undergone within the past two weeks. When she presented to the Respondent on that date, she was in severe pain from the increased intra-ocular pressure in both eyes and appeared to be weak and in great discomfort. Pursuant to order of her doctors who attended and treated her with regard to the abdominal condition and surgery, the patient was and had been "NPO" for four weeks. This condition or situation means that she was forbidden from taking food or liquids of any type by mouth during this period of time. Upon evaluating the pressure in her eyes, the Respondent determined that the intra-ocular pressure in her left eye was 35 millimeters of mercury and in excess of 70 millimeters of mercury in the right eye. This is because the standard instrument with which her pressure was tested by the Respondent only depicts a maximum pressure of 70 millimeters of mercury. The normal intra- ocular pressure for such a patient would be 17-18 millimeters of mercury. Upon evaluating and examining the patient, the Respondent determined her condition to be bilateral acute angle closure glaucoma. He determined that the condition had been present since her surgery 48 hours earlier. The anesthesia from the surgery had precipitated dilation in both eyes which, in turn, precipitated the acute angle closure glaucoma. This occurred because, upon the dilation of the pupils of both eyes caused by the anesthesia, the iris folded back as the pupil expanded, and the folds of the iris occluded or blocked the drain structure by which fluid can drain from within the eye. The inability of the fluid to drain thus caused the severe increase in intra-ocular pressure and thus the glaucoma condition. The Respondent initially treated the acute angle closure glaucoma in both eyes with glycerin. This is a topical medication designed to reduce the amount of swelling in the cornea and to increase absorption of medication into the eye. The Respondent also initially treated the condition with pilocarpine. This is a topical medication administered to constrict the pupil and thus open the channel in the trabecular meshwork (the drainage structure) in an attempt to break the attack of acute angle closure glaucoma by allowing the eye fluid to drain and thus relieve the pressure. The intent is that by constricting the pupil, the iris will stretch with the pupil's closure so as to remove its folds from the position of blocking the channel in the trabecular meshwork. The Respondent initially administered a "beta blocker" medication in an attempt to open the trabecular meshwork by cutting down on the amount of aqueous fluid produced by the ciliary body. The topical medications, indeed, broke the attack of glaucoma in the left eye and the intra-ocular pressure in that eye returned to normal levels. However, after approximately a four-hour trial of the array of topical medications used by the Respondent, the attack of glaucoma in the right eye had not subsided at all. Prolonged elevated intra-ocular pressure of the magnitude of over 70 millimeters of mercury in the right eye posed a great danger of loss of vision in that eye due to potential occlusion of the ocular artery supplying blood to the eye and concomitant permanent damage to the optic nerve. The artery can be occluded or closed off due to such excessive pressure because the pressure at that level will exceed the blood pressure generated by the heart through the vascular system, including the artery supplying that eye. This results in the ocular pressure overcoming the blood pressure within the artery, thus constricting the artery and, therefore, the blood supply to the eye. The loss of blood supply to the eye in a short time, possibly 90 minutes or less, can cause the eye tissue normally served by the artery to become necrotic (i.e. to die). Necrosis of the internal eye tissue, in turn, can cause complications by weakening the pertinent structures of the eye, such as the tissue by which the retina is attached and held in position. The Respondent observed the patient and performed this clinical treatment for approximately four hours without being able to relieve the elevated intra-ocular pressure in the right eye. The Respondent knew, given the symptoms and history with which the patient presented, that severe pain had been experienced by the patient in her eyes since she awakened from the anesthesia administered for her surgery. Thus, he knew that for approximately two days, the glaucoma condition had been operating on the structures of the eye. Accordingly, he knew that time was of the essence if he was going to be able to relieve the glaucoma and thus save the vision, or some of it, in her eye. After these hours of clinical attempts to cure her condition, and in view of the state of urgency the Respondent recognized in the patient, who had already experienced severely-elevated intra-ocular pressure for two days, the Respondent determined that the emergency nature of the patient's situation precluded use of the time necessary to consult with her surgeon and anesthesiologist, to attempt to hospitalize her, to administer a general anesthetic, and perform an alternative surgical procedure. The Respondent, therefore, elected to perform a "vitreous tap". The vitreous tap involves using a hypodermic needle with a "guarded needle" (meaning that the needle is protected so that only a small portion of the point of the needle projects from the guard structure) to withdraw a small amount of the vitreous fluid. This was done to reduce the pressure, open the angles at the trabecular structure in the eye and thus break the attack of acute angle closure glaucoma and return the eye to normal intra-ocular pressure. The vitreous tap was performed at approximately 4:05 that afternoon and was successful. It immediately broke the attack of acute angle closure glaucoma and the intra-ocular pressure returned to a normal range. However, a vitreous hemorrhage resulted from the vitreous tap caused by the needle striking a small blood vessel in the pars plana area of the eye. This area cannot be visualized when performing the vitreous tap because it is inside the eye. A vitreous hemorrhage is a known and accepted complication or risk of a vitreous procedure. However, it has a low incidence of occurrence of approximately 3-5 percent. Upon determining that the hemorrhage condition was present and on or about September 14, 1989, the Respondent obtained a consultation with Dr. James Staman, a vitreal-retinal surgeon, due to the diminished vision in the patient's right eye. Dr. Staman examined the patient and diagnosed a vitreous hemorrhage in her right eye. The incidence of retinal detachment from a vitrectomy is approximately 5-10 percent. It would have had a higher risk in this patient's case, due to the probability of her already suffering permanent damage to the eye and eye tissue caused by necrosis, which was caused by loss of blood supply to the eye during the extended period of high intra-ocular pressure. This likely damaged the optic nerve and occluded the ocular artery serving that eye or portion of the eye. Dr. Staman performed a vitrectomy and removed the hemorrhage or blood from the patient's eye. Unfortunately, a retinal detachment occurred as a complication of that vitrectomy. This chain of events ultimately resulted in the patient losing the vision in her right eye. This was because of the determination that the retinal detachment could not be repaired without causing the loss of vision itself. Dr. Doyle testified as an expert witness for the Respondent. Dr. Doyle is a board certified ophthalmologist specializing in the field of glaucoma and particularly in the sub-specialty area of glaucoma management, including surgical glaucoma management. Additionally, Dr. Doyle is a holder of a fellowship, involving further specialty training in the field of treatment and management of glaucoma and surgical alleviation and management of glaucoma. He is determined to be the most qualified expert witness by training, education and experience in the particular specialty concerning glaucoma, with which this patient's condition is characterized, as is provided in his testimony depicted in the transcript of this proceeding and in his curriculum vitae in evidence. This depiction of his training, education and experience is adopted, by reference, as fact. According to Dr. Doyle, the loss of vision in the right eye was not caused by the vitreous tap. Rather, the precipitating factor was the retinal detachment which occurred as the result of the direct vitrectomy surgery. A vitreous hemorrhage is a known complication of a vitreous tap and a retinal detachment is a known complication of a vitrectomy. The Respondent and all of the expert witnesses agreed that the patient had probably already suffered permanent damage to the right eye, prior to the performance of the vitreous tap, in the form of corneal decomposition, cataract formation and optic nerve damage. Dr. Doyle's testimony, as corroborated by that of the Respondent, established that, in all likelihood, significant necrosis of the eye tissue involved in the structure by which the retina is attached had occurred due to occlusion of the artery supplying blood to that area of the eye by the 48 hours or more of elevated intra-ocular pressure. The elevated intra-ocular pressure occurred as a result of the anesthesia administered to the patient during her abdominal surgery. The Respondent and all expert witnesses agreed that the Respondent had utilized an appropriate and proper procedure in performing the vitreous tap. However, Drs. Baumann and Berg, testifying for the Petitioner, do not agree that the vitreous tap should have been performed to relieve the attack of acute angle closure glaucoma in the right eye. Standard of Care The Respondent met the standard of care under the circumstances with which this patient presented, in his care and treatment of patient D.P. when he performed the vitreous tap to break the attack of acute angle closure glaucoma in patient D.P.'s right eye. The usual treatment options or alternatives for the treatment of acute angle closure glaucoma were not available to the Respondent due to the extremely unusual set of precipitating circumstances with which the patient presented to him. The patient had already had extreme intra- ocular pressure of approximately 48 hours duration, based upon all of the evidence available to the doctor in performing his diagnosis and examination of treatment options. Dr. Baumann admitted that the situation was "urgent", and Dr. Berg admitted that the situation was an "emergency" and that the Respondent's "back was up against the wall" under the circumstances. Because of this, the treatment, including surgical options preferred by Drs. Baumann and Berg, was not effectively available to the Respondent in an attempt to save the vision in the patient's eye. This is because, in order for a general anesthetic to be administered and the patient prepared, monitored and evaluated for the surgery, she would have had to be hospitalized, with accompanying consultation with her internal medicine physician, her abdominal surgeon, and the anesthesiologist. All of this process would have taken approximately six hours, from the time the decision was made to perform the vitreous tap, which was made when the topical medications failed to alleviate the attack, until the surgery could be performed in the hospital. Even if the patient's eye was not already significantly damaged by the 48 hours of elevated intra-ocular pressure when she presented to the Respondent at his office, substantial damage to her vision would have occurred as a medical certainty if another six hours had elapsed after the unsuccessful conclusion of conservative, clinical treatment between 4:00 p.m. and 4:30 p.m. The first treatment option in an angle closure glaucoma case is topical therapy in an attempt to reduce the production of fluid by the ciliary body in the eye and to cause the iris to constrict and thus open the angle and its drainage structure. The Respondent initially treated the angle closure glaucoma in both eyes with topical medications, including pilocarpine, glycerin and a beta blocker. He repeated this topical therapy for approximately three hours at the appropriate intervals which all testifying physicians, including Dr. Doyle, agree was "normal, appropriate care". Under ordinary circumstances, if the topical medications failed to lower the intra-ocular pressure, the use of diamox or mannitol would be the next treatment alternative to try. However, diamox, a carbonic anhydrase inhibitor, which affects the ciliary body to reduce the production of fluid, would not have produced any greater benefit than the topical medications which had failed already. Mannitol is a hyperosmotic medication. It is ordinarily administered by mouth, which allows the body's stomach and intestines to regulate and gradually accomplish a safe absorption of the medication. However, oral mannitol was not an option to this patient because, under her previous doctor's orders, she was not allowed to take anything by mouth at times pertinent to this proceeding, including the day and times when the Respondent was treating her for the glaucoma. Mannitol reduces vitreous volume by reducing water everywhere in the body, including the eyes. The fluid is drawn into the blood stream, which, however, increases blood volume. Administration of mannitol intravenously would have put the patient at significant risk for an overload of volume in the blood which would have caused readily increased blood pressure with attendant possible medical complications, massive congestive heart failure, or kidney problems. These are life-threatening risks which would have necessitated hospitalization, evaluation and monitoring in the hospital before and during administering of intravenous mannitol. By the time this could have been accomplished, the vision in the eye would have already been lost. Dr. Doyle and the Petitioner's expert, Dr. Baumann, both agreed that administration of intravenous mannitol would have been dangerous for this patient. Intravenous mannitol is only 50 percent effective in such a situation, in any event, and is contra-indicated in patients such as D.P., who are post- gastrectomy surgery. This 65-year-old patient, weakened by her second gastrectomy surgery in a four-week period, involving the use of general anesthetics, was simply not a safe candidate for the administration of mannitol under the risky intravenous method which would have been necessary with the patient. The risk of kidney or heart failure and other complications was simply too great. The Petitioner's expert, Dr. Baumann, admitted that it was reasonable for the Respondent to have these concerns about the use of diamox and intravenous mannitol and further that the Respondent was not negligent in deciding not to use those medications. Under ordinary circumstances, if the topical therapy and the administration of medication failed to relieve an attack of acute angle closure glaucoma, the next course of treatment to be considered would be an argon or YAG laser iridectomy or an irridoplasty in order to place a small hole in the iris to relieve the pressure differential in the eye. A laser is a focused beam of light, at high energy, which can insert the necessary hole in the eye to relieve the intra-ocular pressure. It requires a clear media over the iris in order to penetrate the eye and make the hole in the required position. In this case, due to the extraordinary high intra-ocular pressure over a two-day period, the cornea was very cloudy and hazy. This precluded the laser being effective and created the potential for damage to the cornea had the laser been directed against the eye. Dr. Doyle and the Petitioner's experts, Dr. Berg and Dr. Baumann, all agreed, that in a patient such as D.P., with intra-ocular pressure of over 70 millimeters of mercury extending for 48 hours, the cornea would be very cloudy. The Respondent's testimony confirms this. After the vitreous tap was performed and the intra- ocular pressure relieved, the edema and cloudiness of the cornea resolved itself so that the Respondent was able to perform a successful argon laser iridectomy the following day and a YAG laser irridoplasty in his office five days later, to prevent a recurrence of the problem by providing an additional means of fluid drainage. Under ordinary circumstances where topical therapy, medication therapy, and laser iridectomy had either failed or were not viable options, then surgical treatment would be the next consideration. The surgery would include either surgical iridectomy or a trabeculectomy. A surgical iridectomy creates a small hole in the iris which relieves the pressure. A trabeculectomy creates a secondary drain for the eye. The Respondent was justified in not pursuing a surgical iridectomy or trabeculectomy in that the surgery could not have been done under a local anesthetic and would have required general anesthesia. This is undisputed. This would have required surgery in the hospital operating room, including the necessity for insertion of a tube, which might have caused risk to her recent abdominal surgery. It would have necessitated contacting her surgeon, her internal medicine physician, and her anesthesiologist for pre-surgical evaluation and clearance. This would have taken considerable time, at least six hours, thereby, within reasonable medical certainty causing permanent significant damage or entire loss of vision to the eye. A surgical iridectomy or trabeculectomy are not benign procedures and carry the highest complication rate of any ophthalmic procedure, when used for malignant glaucoma and, indeed, the accepted treatment for malignant glaucoma (albeit a different type of glaucoma condition) is a vitreous tap. Either surgical procedure would have had a risk of complication resulting in loss of vision in the eye of at least 3-5 percent or more, thus, the same or greater level of risk than that attendant to the vitreous tap procedure. Paracentesis, a surgical procedure to make a small hole in the anterior chamber of the eye, was itself not a reasonable treatment alternative under the circumstances. It was simply not feasible because the anterior chamber of the eye had virtually ceased to exist because the iris diaphragm had bulged forward through the space normally occupied by the anterior chamber because of the great pressure behind it. Dr. Doyle established that the Respondent's vitreous tap effected a complete cure of the glaucoma condition in patient D.P. A vitreous tap is a procedure recognized in the medical literature as a treatment for several ophthalmic conditions, including malignant glaucoma, positive pressure during cataract surgery, and for the purpose of obtaining vitreous material for pathological testing (biopsy). The medical literature, indeed, does not address the use of a vitreous tap as treatment for acute angle closure glaucoma because the medical literature and text books tend to deal with more common presentations of all diseases. None of the literature addresses treatment of acute angle closure glaucoma under the unusual set of emergency circumstances presented with this case. The Respondent's expert, Dr. William Doyle, is a board-certified ophthalmologist who has a sub-specialty in glaucoma management and treatment, including surgical management thereof. He is one of only a handful of fellowship-trained glaucoma specialists in the State of Florida and the only one in the North Florida area. He sees patients on referral from other doctors in Florida and South Georgia, who have unusual glaucoma-related problems. Dr. Doyle is an assistant professor of ophthalmology at the University of Florida and is responsible for teaching glaucoma management and treatment. He has authored some twelve article, book chapters, and other publications specifically in the field of glaucoma management and treatment. According to Dr. Doyle, if the vitreous tap procedure had been successful, the Respondent "should have written it out for the literature as a viable, interesting way to cure a disease". The Petitioner's expert, Dr. Berg, in his report attached to his deposition, referenced an article in International Ophthalmology Clinics, by Kevin C. Greenridge, M.D., of the Metropolitan Hospital Center, Department of Ophthalmology, New York, New York, and which Dr. Berg admitted was authoritative in the field of acute angle closure glaucoma. The article specifically states that in cases of acute angle closure glaucoma, for a duration of more than 24 hours, the eyes are more inflamed and have evidence of corneal decomposition, which are relative contra indications to argon laser iridectomy. Since the acute angle closure glaucoma had a duration of 48 hours when the Respondent first saw the patient, corneal decomposition could have been significantly advanced by that point such that the set of conditions requisite to causing the retinal detachment, which ultimately led to the loss of the patient's sight in that eye, were likely already in place. Thus, the vitreous hemorrhage caused by the vitreous tap may not itself have been the cause of the loss of sight. Medical Record Issue The Respondent's office records note "Vitreous tap. 4:30 p.m., immediately patient felt better". The Respondent also made an entry in the patient's hospital chart on the date of the vitreous tap which noted: Acute angle closure glaucoma right eye. Totally unresponsive to treatment. Pressure of 70 unaffected by treatment. Pars plana 1/2 cc vitreous tap done with immediate relief. Both eyes very shallow [referring to anterior chamber]. Started on pilocarpine and both eyes will need argon laser iridectomy soon. A copy of the hospital note was included and contained in the Respondent's records of the patient. In addition, the Respondent obtained a signed, written, informed consent for the procedure. The Respondent's records, including his office records and the note in the hospital chart, adequately document the course of therapy leading up to the vitreous tap and the vitreous tap procedure itself such that the Respondent's medical record keeping would adequately inform the Respondent in the future when reviewing the patient's records with a view toward further follow-up and treatment of the patient's entire status. They would also adequately inform any physician to whom the patient was later referred by the Respondent of her status, the treatment and procedures performed, and the symptoms and diagnosis involved in the patient's care and treatment.
Recommendation Based on 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 RECOMMENDED that the Respondent be found not guilty of violating Sections 458.331(1)(m) or (t), Florida Statutes, and that the Administrative Complaint against the Respondent be dismissed in its entirety. DONE AND ENTERED this 7th day of September, 1994, in Tallahassee, Florida. P. MICHAEL RUFF 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 7th day of September, 1994. APPENDIX TO RECOMMENDED ORDER, CASE NO. 93-5990 Petitioner's Proposed Findings of Fact 1-16. Accepted, but not necessarily for their purported material import. Rejected, as contrary to the preponderant, probative evidence. Accepted. Accepted, but not itself dispositive of the material issues presented. Accepted. 21-26. Accepted, but not necessarily for their purported material import and subordinate to the Hearing Officer's findings of fact on this subject matter. 27. Accepted, but subordinate to the Hearing Officer's findings of fact on this subject matter and as not probative of the medical records being inadequate as a matter of fact and law. 28-29. Accepted. 30. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter and not entirely in accordance with the preponderant weight of the evidence. 31-41. Accepted, but subordinate to the Hearing Officer's findings of fact on this subject matter and not dispositive of the material issues presented. 42-43. Rejected, as contrary to the preponderant weight of the evidence and subordinate to the Hearing Officer's findings of fact on this subject matter. 44-46. Rejected, as contrary to the preponderant weight of the evidence and subordinate to the Hearing Officer's findings of fact on this subject matter, and for the additional reason that these proposed findings are not dispositive of the material issues presented. 47-50. Accepted, in part, but not as materially dispositive of the issues presented for resolution and as subordinate to the Hearing Officer's findings of fact on this subject matter. Rejected, as contrary to the preponderant weight of the evidence and subordinate to the Hearing Officer's findings of fact on this subject matter. Accepted. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. Respondent's Proposed Findings of Fact 1-55. Accepted, to the extent not rejected by or subordinate to the Hearing Officer's findings of fact. Those proposed findings of fact not treated in the Hearing Officer's findings of fact are rejected as unnecessary or immaterial. COPIES FURNISHED: Alex D. Barker, Esquire Department of Business and Professional Regulation 7960 Arlington Expressway Suite 230 Jacksonville, Florida 32211 Jeptha F. Barbour, Esquire Post Office Box 447 Jacksonville, Florida 32201 Dr. Marm Harris Executive Director Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792 Jack McRay, Esquire Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792
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
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 Whether Respondent's license as a physician should be disciplined for the alleged violation of Section 458.331(1)(t), Florida Statutes, in that Respondent failed to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances, by failing to treat the patient's preoperative coagulopathy and/or failing to use an alternate vein that would have allowed visualization of the shunt placement into the vein thereby reducing the risk of causing a hemorrhage given the patient's preoperative history, and, if so, what penalty should be imposed. AS TO CASE NO. 01-4407PL Whether Respondent's license as a physician should be disciplined for the alleged violation of Section 458.331(1)(t), Florida Statutes, by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances by failing to distally clamp part of the arteries prior to manipulation of the aneurysm and by failing to ensure periodic monitoring of the patient's condition postoperatively for evidence of ischemia or other problems and, if so, what penalty should be imposed.
Findings Of Fact Based on the evidence adduced at the final hearing, and the entire record in this proceeding, the following findings of fact are made: FACTS COMMON TO BOTH CASES Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.42, Florida Statutes, Chapters 456 and 458, Florida Statutes. At all times relevant to this proceeding, Respondent was a licensed physician in the State of Florida, having been issued license number ME 0036360. Respondent is board-certified in thoracic and general surgery. FACTS RELATED TO CASE NO. 01-4406PL Patient D.J.P. was a 54-year-old female with a history of liver resection for carcinoma. Patient D.J.P. had contracted Hepatitis C in the 1960s from a blood transfusion, after being the victim of a gun shot wound during a robbery at a convenience store. Patient D.J.P. subsequently had developed cirrhosis secondary to the Hepatitis C. Cirrhosis is a scarring process of the liver that results in the displacement of the normally functioning liver tissue. A healthy liver processes lymphatic fluid back into the bloodstream. However, a cirrhotic liver cannot properly process the lymphatic fluid back into the bloodstream. Therefore, lymphatic fluid backs up within the liver and weeps out the covering over the liver and into the abdominal cavity. Patient D.J.P. presented to Respondent on February 1, 1994, after being referred to Respondent by Michael Carey, M.D., the primary care physician, for evaluation for implanting a peritoneal venous shunt. A venous shunt is a conduit designed to take ascitic fluid from the abdomen and put it back in the vascular system. The shunt removes the fluid from the abdominal cavity and transports it to the vascular system where it can be absorbed. The procedure is for the patient's comfort and does not prolong the patient's life. The procedure is for patients with end stage liver disease. After obtaining a medical history and conducting a physical examination, Respondent's assessment of the Patient D.J.P. was massive ascites secondary to cirrhosis and previous liver resection. Respondent believed that Patient D.J.P. was a candidate for a venous shunt procedure due to the fact that she was very symptomatic from her massive ascites and she was on the maximum medical therapy. The mortality rate for this type of procedure is between 5 and 25 percent or at the very least, one-in-twenty patients would die from this procedure. Complications associated with this type of procedure include disseminated intravascular coagulopathy (hereinafter referred to as "DIC") which may lead to the general worsening of the disease or death. The patient was informed of this mortality rate as well as of the complications associated with this procedure. Patient D.J.P. decided to think about the procedure and contact Respondent's office when she wanted the shunt inserted. On February 10, 1994, Patient D.J.P. called Respondent's office and asked to have the shunt inserted as soon as possible. Respondent scheduled the procedure for February 14, 1994, and signed the written surgical consent form. Prior to the surgery, lab tests were performed on Patient D.J.P. The lab report indicated that the patient's prothrombin time was 14.3, with a normal range being 10.7-12.8. Prothrombin time ("PT") is a measurement of one aspect of the blood clotting mechanism. This was considered slightly abnormal and not an indication of a clotting problem or coagulopathy. Respondent decided it was not necessary to address Patient D.J.P.'s abnormal PT prior to the procedure by preoperatively administering Vitamin K or fresh frozen plasma. On February 14, 1994, Patient D.J.P. was transported to the operating room at approximately 12:10 p.m. After Patient D.J.P. was placed under general anesthesia, Respondent began the venous shunt operation at approximately 12:34 p.m. Respondent attempted to access the right jugular vein to insert the shunt. He found this vein to be unusable because it was too scarred from previous surgeries. Respondent then proceeded to access the right subclavian area to insert the shunt. Once the shunt was inserted into the subclavian area, Respondent positioned it in the superior vena cava. The shunt was noted to be in position in the superior vena cava. Respondent then removed eight liters of ascitic fluid from the abdominal cavity. After removing the ascitic fluid, he then put one liter of saline into the abdominal cavity to dilute any remaining ascitic fluid which allowed any remaining fluid to be more easily absorbed into the vascular system. The Patient's central venous pressure dropped from 8 to 2. Hespan and Albumin were then administered to replace any lost volume and it helped to increase the colloidomotic pressure. At this point, Patient D.J.P.'s central venous pressure (CVP) increased from 2 to 14 or 15. This is a faster than normal rate. Upon finding that the shunt was operating well, Respondent closed the abdominal portion and the patient was extubated. Petitioner claimed that fluoroscopy was not used to ensure that the shunt was positioned in the proper place. A Fluoroscope is like a real-time X-ray. A fluoroscope has two parts to it: a C-arm, which goes above the patient and underneath the bed, and two screens where the doctor can see what is going on. The C-arm is approximately 5-and-a-half feet tall. It is below the standard of care to do a venous shunt procedure without using a fluoroscope. It would enable Respondent to visualize the placement of the shunt. Felicia Whitmer, a scrub technician, and Rene Myers, a circulating nurse, prepared the operating room for Patient D.J.P.'s procedure on February 14, 1994. Both Felicia Whitmer and Rene Myers testified that there was no fluoroscope in the operating room on February 14, 1994. Respondent testified that there was a fluoroscope in the operating room on February 14, 1994, during Patient D.J.P.'s procedure and that he used it to assist him. The evidence is not clear and convincing that the fluoroscope was not used during the course of the operation. It is considered within the accepted standard of care to access the right subclavian vein to insert a shunt of this type because this vein follows a gentle curve or path. With this gentle curve in the vein, there is less risk of damage, i.e. puncture, to the vein. In contrast, the left jugular vein follows a more sharp-angled 70-degree bend-curve in the vein where one risks the danger of the shunt coming out of the bottom of the vein or perforation and, thereby, damaging the vein. Respondent ordered an X-ray to confirm placement of the shunt and catheter. The X-ray revealed that the shunt had good positioning but the right lung was filled with fluid. The patient was re-intubated and Respondent inserted a chest tube into the patient which would expand the patient's lung, oxygenate the patient and allow for fluid removal. Three or four liters of fluid were removed. The fluid was originally serous and pink tinged and shortly thereafter, turned bloody. Respondent noted that there was bruising around the wounds. Additionally, the patient's breathing became shallow and her blood pressure began to deteriorate. Resuscitative efforts were performed and Respondent re- entered the shunt area to clamp the shunt to prevent any ascites from flowing into the venous system and to prevent further coagulation and massive bleeding. Despite heroic resuscitative efforts, the patient's condition continued to deteriorate and the patient died. The cause of death was determined to be DIC and severe coagulopathy from drainage of the ascitic fluid into the venous system. Respondent made the determination that the patient did not have preoperative coagulopathy. Respondent testified that if the patient did have preoperative coagulopathy, he would not have performed the procedure because the patient would not be able to make the clotting factors well enough for problems that would occur after the shunt was inserted. It was Respondent's opinion that the patient did not have a serious clotting problem. Based on her lab report, Patient D.J.P. had a slightly abnormal PT and this was not an indication of a clotting problem. Respondent reviewed the lab reports and determined the PT (the measurement of one aspect of blood clotting mechanism), to be only slightly elevated. It measured 14.3 with a normal range being 10.7-12.8. Moreover, the PT International Normalized Ratio (INR) (which is the standardized measurement of PT) was 1.63 where the therapeutic range was 2-3. Therefore, this was slightly below average. Dr. Yahr testified that an abnormal clotting problem is a clinically evident problem and not an incident of a lab number. If Patient D.J.P. had a clotting abnormality, adverse conditions or symptoms would have been evident with the incisions that were made prior to the shunt being opened. Rather, normal clotting reactions occurred. Coagulation occurred right after the shunt was opened and the ascitic fluid began to flow into the atrium. Dr. Yahr testified that the etiology of the coagulation was the body's reaction to the ascitic fluid after the shunt was opened. Accordingly, it was Dr. Yahr's opinion that Respondent did not fail to treat the preoperative coagulopathy because upon his examination of the patient, he determined that no such preoperative coagulopathy existed prior to the procedure. Dr. Yahr testified that the patient did not have abnormal bleeding. Her liver failure was the result of scarring and abnormal liver function. Therefore, administration of clotting factors such as Vitamin K and fresh frozen plasma was not indicated or medically necessary. Petitioner presented the expert testimony of John W. Kilkenny, III, M.D. Dr. Kilkenny is board-certified in general surgery and has been for 11 years and is currently a professor with the University of Florida College of Medicine, Department of Surgery in Jacksonville, Florida, a position which he has held for the last six years. According to Dr. Kilkenny, Patient D.J.P.'s elevated PT was a cause for concern in that it was an indication that the patient's ability to clot or coagulate was diminished. It is not clear and convincing that the standard of care required that the elevated PT be treated by infusing fresh frozen plasma or Vitamin K. Respondent did not violate Section 458.331(1)(t), Florida Statutes, by failing to use an alternate vein that would allow visualization of the placement of the shunt. Respondent first attempted to access the right jugular vein to insert the shunt but found it be unusable because it was too scarred. Respondent, acting as a reasonably prudent physician and using sound medical judgment, accessed the right subclavian area to insert the shunt. After the shunt was inserted into he subclavian vein, Respondent claimed he was able to visualize the placement of the shunt by the use of fluoroscopy. Furthermore, the operative notes seemed to indicated that the procedure was performed under fluoroscopic control and the shunt was found to be in position. Therefore, Respondent accessed an appropriate alterative vein-the subclavian vein, which allowed visualization, with the assistance of fluoroscopy, of the placement of the shunt. As to the second issue, Dr. Kilkenny opined that the standard of care requires direct visualization for insertion of the shunt. By not accessing a vein under direct visualization, such as with Respondent's subclavian approach, the surgeon is, in essence, hunting for the vein, and risking damage to the wall of the vein that may not be evident immediately. The rapid rise in CVP from 2 to 14 or 15 was also a concern for Dr. Kilkenny because it was not normal, and did not mean that the shunt was placed correctly of that the shunt was functioning properly. Dr. Kilkenny noted that it was unlikely that the bleeding in the chest cavity was caused by damage to an intercostals vessel when the chest tube was inserted because the chest X-ray that was taken prior to insertion of the chest tube showed a complete opacification of the right side and a shifting of the major vessels within the middle of the chest over to the left side. According to Dr. Kilkenny, the chest X-ray indicated that there had already been some sort of bleeding in the right chest prior to the insertion of the chest tube. Dr. Kilkenny disputed Respondent's theory that Patient D.J.P. died as a result of DIC. Dr. Kilkenny asserted that Respondent fell below the standard lf care in that, given Patient D.J.P.'s rapid decompensation, he failed to consider whether the patient's subclavian vein had been damaged, a condition which could have been addressed surgically. Dr. Yahr opined that Patient D.J.P. died of DIC that occurred within a short period of time after Respondent opened up the shunt and ascitic fluid was introduced into the atrium of the heart. Although Dr. Yahr further admitted that the bleeding in the chest could have occurred as a result of damage to the subclavian vein, and that it was below the standard of care to access the subclavian vein without using fluoroscopy, the evidence is not clear and convincing that either event occurred. It is found that Petitioner has failed to establish by clear and convincing evidence that the standard of care required Respondent to use an access site that allowed direct visualization of the placement of the shunt into the vein, or that Respondent failed to use fluoroscopy in order to directly visualize insertion of the shunt into the subclavian vein. AS TO CASE NO. 01-4407PL On August 22, 1997, Patient H.H., a 55-year-old female, was diagnosed with an abdominal aortic aneurysm measuring approximately 4.5 cm transverse diameter and beginning approximately 1-2 cm below an enlargement or swelling, of a blood vessel resulting in a weakening or thinning out of the vessel wall. On November 28, 1997, Patient H.H.'s aneurysm had grown to 5 cm within a three-month period and was occluded with partial thrombosis with a true lumen around 2.7 cm and extended down to the bifurcation of the abdominal iliac. This put the patient at risk for rupture of the aneurysm. Thrombosis is a blood clot within a vessel or within the vascular system. It does not embolize (travel) from another part of the body. It starts in a particular vessel and causes its damage from there. It is an acute clot that occurs in the vessel secondary to stasis (non-moving ) or some kind of coagulation or clotting deficiency or abnormality. Thrombotic activity most often begins by occluding the smaller vessels in the vascular system, such as those smaller veins located in the feet. On December 2, 1997, Patient H.H. first met with Respondent, who performed a complete medical history and physical examination and confirmed the presence of a 5 cm abdominal aneurysm. Patient H.H. was a 55-year-old female who smoked 1- and-a-half packs of cigarettes per day, had a blood pressure of 182/104 despite the fact that she was taking 50 mg Atenolol for hypertension (high blood pressure), and had a 30 percent blockage of the coronary artery. Previously, she had a cardiac catheterization, followed by an angioplasty of the femoral vessel in her left leg. Patient H.H. advised Respondent that her legs gave out on her after she walked two blocks, but that she did not have associated chest pain. Respondent confirmed earlier diagnosis of Patient H.H.'s medical condition as single vessel coronary artery disease, abdominal aortic aneurysm, hypertension, and claudication with femoral occlusive disease. Respondent also found diminished femoral pulses and palpable Dorsal pedal pulses present in both feet. Patient H.H.'s medical records indicated that this smoker of 30 years suffered from diabetes, peripheral vascular disease, intermittent clottication of the leg, hypertension, atherosclerotic disease, hypercoagulopathy, anthithrombin III deficiency, high cholesterol, and diminished protein and pH levels. Respondent prescribed prescription medication, Procardia to lower Patient H.H.'s blood pressure and Zyban to help her stop smoking. He recommended that the patient return in a week for follow-up. On December 15, 1997, Respondent continued to prepare Patient H.H for surgery. He again advised her to stop smoking and to purchase and take medication to help her stop smoking. Patient H.H.'s blood pressure was lower, 144/84, and although she had not purchased or taken the medication, she reduced her smoking down to one-half pack of cigarettes per day. Respondent then advised Patient H.H. to make plans to undergo the abdominal aortic aneurysm ("AAA") repair. Patient H.H. informed Respondent that she wanted to wait a little longer while she made financial arrangements to pay for the surgery. Respondent advised Patient H.H. to completely quit smoking before the surgery and advised her to return in one month for additional preoperative evaluation. On January 12, 1998, Respondent continued to prepare Patient H.H. for surgery by ordering a cardiac clearance (thallium evaluation) of the patient's heart to ensure she could tolerate the surgery before attempting the AAA repair. On February 3, 1998, Patient H.H. presented for the thallium evaluation of the heart and, on February 9, 1998, obtained cardiac clearance for repair of the AAA. On February 11, 1998, Respondent continued to prepare Patient H.H. for AAA surgery and suggested she donate two units of blood which would be used during the surgical procedure. Respondent scheduled AAA repair surgery for March 6, 1998. Respondent advised Patient H.H. of the risks associated with AAA surgery and specifically mentioned the risk of a heart attack, bleeding, kidney damage and loss of legs. He also advised that the risks associated with intra-operative AAA repair include spontaneous rupture, embolization of material from the wall distally, myocardial infarction, bleeding, injury to viscera of the small vessels, devascularization of the colon causing ischemic colitis, death, kidney blockage. Patient H.H. indicated she understood the risks and despite the risks associated with this type of surgical procedure, including the risk of death, she agreed to the procedure. Preoperative testing by angiogram was not required for Patient H.H. The aneurysm was a massive aneurysm presenting a very serious health risk of imminent rupture. The size of Patient H.H.'s aneurysm (5 cm) made AAA repair an emergency in a sense because there was almost a 100 percent chance of rupture with in the next six months. Any findings determined by angiogram would not have changed the outcome of the case because Respondent had to definitively treat the aneurysm first. Additionally, an angiogram is a very expensive test and Patient H.H. expressed a concern about her financial situation with respect to the AAA repair. It is reasonable to not do studies that a physician does not feel are absolutely necessary. The patient's financial concerns are part of the pathology. On March 6, 1998, Patient H.H. was admitted to Winter Haven Hospital and filled out and signed the Special Authorization for Medical and/or Surgical Treatment form indicating her consent to the surgical procedure which Respondent was to perform. She indicated that she understood the risks associated with such surgical procedure. Paragraph two of the informed consent form states in pertinent part: I hereby certify that I have given complete and informed consent for the above named operation and/or procedures, and Dr. L. Thomas has explained to me the reason why the above-named operation and/or procedure are considered appropriate, its advantages and possible complication, if any, as well as possible alternative modes of treatment. I also certify that no guarantee or assurance has been made as to the results that may be obtained. The operative procedure on the consent form was signed by Patient H.H. at 6:10 a.m. on March 6, 1998. Surgery indicated on the consent form was for a resection abdominal aortic aneurysm (AAA repair). After Patient H.H. was taken to the operating room and administration of anesthesia began, Respondent performed his routine preoperative check of femoral and pedal pulses. Checking for femoral and pedal pulses is the type of preoperative work-up Respondent routinely performs while he waits for the anesthesia to take its effect on the patient. The operative report indicates that the abdominal aneurysm was "very large" extending quite high within 1-2 cm from the renal vein and down to and involving the common and hypogastric arteries and noted to be "quite saccular" with "impending rupture in the near future at the neck." The common iliacs were noted to be "quite large and aneurysmatic." The external iliacs were soft but extremely small, "approximately 4-5 mm in size, certainly less than half, more like 1/4 the size of a normal iliac" but nevertheless usable vessels to make his anastomosis. As Respondent was bluntly dissecting (separating the tissues using the fingers) the aortic aneurysm from the venous plexus to position his proximal clamp when one of the lumbar veins was encountered and mass bleeding occurred. The venous plexus is a grouping of veins located under the aorta that can best be described as a wagon wheel. The system has a hub and all the veins in the grouping extend outward from the hub. If one of the veins in the grouping is injured, it will bleed heavily, but the bleeding is controllable. The lumbar veins are part of the venous plexus and a tear of the lumbar vein is a known risk during this type of surgery. Patient H.H. suffered the loss of three times the amount of blood as would have been routinely expected. The sudden blood loss caused the patient's condition to rapidly deteriorate. Dr. Wickstrom-Hill, Anesthesiologist, testified that had Respondent not controlled the blood loss, and had not maintained Patient H.H.'s vital signs, she would have died. Using sound medical judgment, Respondent elected to bypass the aneurysmatic common iliacs and make his anastomosis of the graft to the external iliacs in order to not disconnect or separate the aortic or common iliac aneurysms from the iliac vein. This is a very fragile vessel and could have resulted in further massive bleeding and possible death of the patient. A reasonable prudent physician faced with a similar circumstance and situation would not attempt to mobilize the aneurysm further if doing so would cause additional massive blood loss and possible death of the patient. The hypogastric arteries (a/k/a the internal iliacs) serve to provide the pelvic viscera (bladder, rectum, etc.) with blood. During the AAA repair, Respondent performed an embolectomy on both legs following manipulation of the aneurysm. The purpose of this procedure was to remove any debris which may have dislodged from the aneurysm and flowed distally to the legs. The procedure involves running a Fogarty catheter down the femoral arteries as far as the catheter will go, then inflating a balloon located at the end of the catheter. Once the balloon is inflated, the surgeon will extract the catheter, pulling the debris out of the artery. This process is repeated as necessary to remove all debris. Fresh clot was obtained from both legs, indicating a lack of debris. Prior to completing the anastomosis of the bifurcated graft to the aorta and external iliacs respectively, Respondent ran a Fogarty catheter down proximal (back into the graft itself), to remove any debris in the graft itself. Finally, he back-bled the graft (allowed blood to flow out of the graft, to, again, ensure that there existed no debris in the graft). On March 7, 1998, Patient H.H.'s medical condition stabilized such that Respondent felt it safe to return Patient H.H. to the operating room to undergo an additional embolectomy of the legs and an endarterectomy of the right femoral artery. The record demonstrates that Respondent believed he collected embolic debris from the femoral arteries. However, based upon the pathology report and the testimony of Dr. Zeller, the debris removed from Patient H.H. during this procedure was acute blood clots and atherosclerotic plaque. This finding is consistent with thrombotic material and not a result of debris coming from another location as it tends to demonstrate that Patient H.H. had a clotting disorder consistent with her medical history. The record also demonstrates that upon completion of the procedure, Patient H.H. was noted to have excellent pulses in the superficial and profunda femoral arteries distal to the anastomosis with good emptying and filing of the vessels. Before, during, and after the AAA repair, Respondent used Heparin (an anti-clotting drug) in an effort to prevent the formation of clots throughout Patient H.H.'s vascular system. Intraoperatively, on March 3, 1998, Respondent administered 10,000 units of Heparin. Normally a patient will respond to 5,000 units. Despite giving Patient H.H. twice the normal amount of Heparin, Patient H.H. continued to have a lowered clotting time. It is noted in the medical record that Patient H.H. had an Antithrombin III deficiency. Antithrombin III is one of the factors that control how blood in the human body clots. Patient H.H.'s Antithrombin III deficiency is a hereditary defect that contributed significantly to her continued clotting despite the use of pharmacological intervention (substantial amount of Heparin). Respondent testified that in his medical training and experience, Patient H.H.'s Antithrombin III deficiency level was near fatal. Because Patient H.H. was hypercoagulative, thus causing the small vessels to clot off, on March 13, 1998, Patient H.H. underwent bilateral above the knee amputations. Hypercoagulopathy is a tendency to clot without anything being done - the blood just clots. This can be caused by a lower-than- normal blood pressure for a period of time and by having an Antithrombin III deficiency. Respondent observed during the surgery that this patient was hypercoagulative because he could see the blood clotting in the wound despite the fact that Patient H.H. was on twice the normal amount of Heparin. Respondent practiced within the standard of care at all times during the treatment of Patient H.H. Blood-flow going retrograde back into the common and iliac aneurismal sacs did not place Patient H.H. at a risk of rupture. The operative report clearly demonstrates that the aortic aneurysm involved the common iliacs and extended below the hypogastric arteries. The operative report also demonstrates that the external iliacs were extremely small, approximately one-quarter of the normal size. A reasonable and prudent surgeon, faced with a similarly situated patient with a massive sized aneurysm and the extremely small size of the distal external iliacs, would conclude that the pressure gradient now being carried to the graft rather than to the aneurysm would diminish flow to the aneurysms making the possibility of rupture unlikely. Moreover, the aneurysms were filled with calcified atherosclerotic plaque and other thrombotic (non-mobile) material. Dr. Begelman testified that calcified aneurysms do not tend to rupture as much. On direct examination, Dr. Begelman, Petitioner's expert, could not conclusively determine whether Respondent's surgical treatment of Patient H.H. fell below the standard of care and that distal clamping is an intra-operative decision to be made by the surgeon. Dr. Begelman who testified that he accepted Respondent's opinion that the iliacs were too large or too thin walled and could not distally clamp the aneurysm and that such decisions are those made by the surgeon on the case. Drs. Begelman and Seller and Respondent testified that it is usual and customary during this type of surgical procedure to distally clamp the aorta and that it is expected of a reasonable and prudent surgeon to make every attempt to do so. Nevertheless, all three doctors recognized that there are times when you cannot or should not distally clamp if to do so would cause further injury to the patient or death. Patient H.H. presented with very massive aneurysms of both the aorta and common iliacs making distal clamping impossible without sacrificing the hypogastric arteries thus placing Patient H.H. at risk for further injury or death. Petitioner's expert accepted Respondent's assessment of the condition of the iliacs and that Respondent did not want to dissect the iliacs off the iliac vein, which one needs to do in order to tie off distally. Dr. Begelman testified that he could not ascertain whether Respondent fell below the standard of care with respect to Respondent's treatment of Patient H.H. intraoperatively. Respondent acted within the standard of care and, therefore, did not violate Section 458.331(1)(t), Florida Statutes, when he did not clamp the distal arteries before manipulation of the aneurysm. Respondent did not violate Section 458.331(1)(t), Florida Statutes, by sewing the bifurcated graft to the external iliacs and making no attempt to disconnect the aneurysm from the common and internal (a/k/a hypogastric) iliacs. The common and internal iliac tissues were also diseased because of their involvement with the aneurysms coupled with the fact that the aneurysm and surrounding tissue was inflamed. Inflammation causes the tissues of the surrounding viscera to become sticky and by that, stick together making separation difficult and more prone to bleeding on manipulation. Normally, the surgeon must bluntly dissect (lift up) the distal end of the aorta in order to place the distal clamps on the aorta below the aneurysm. However, the inflammation present in Patient H.H.'s aorta made it impossible to mobilize (lift up) the distal aorta for clamping because the tissue was stuck to the iliac vein which could have caused Patient H.H. to suffer a lethal blood loss. Normally, blood loss associated with this type of surgery amounts to 500 ccs for the total surgery. Patient H.H. lost 1500 ccs during the manipulation of the aortic aneurysm to place the proximal clamp and a total of 2400 ccs during the entire surgery which represented a blood loss of nearly 25-40 percent respectively of her estimated total blood volume. Respondent used sound medical judgment by making no attempt to dissect the common iliac from the subordinate tissue because, in his training and experience, the separation of tissues would have caused further, possible lethal bleeding. Drs. Begelman and Zeller, experts for Petitioner and Respondent respectively, testified that a reasonably prudent surgeon would not clamp below the common iliacs if to do so would sacrifice the hypogastric arteries and thereby cause irreparable harm or death to the patient. Dr. Zeller testified that the hypogastric arteries are of such importance that not clamping them, even at the risk of embolization, would nevertheless be within the standard of care. Respondent closely monitored Patient H.H. postoperatively. A reasonable and prudent surgeon is not expected to remain in the recovery room with his post-surgical patient until the patient becomes stable. Rather, the reasonable and prudent surgeon is expected to utilize the nursing staff who are charged with attending to the patient and to keep the physician updated on the patient's medical condition. Petitioner's witness, Doris Gutierrez, was the recovery room nurse on duty on March 6, 1998. Her duties included monitoring and reporting changes in Patient H.H.'s condition to Respondent. The record demonstrates that Respondent closely monitored Patient H.H. postoperatively by being in contact with the nursing staff and thereby giving orders for care and treatment to the nursing staff, either by telephone orders ("TO") or in person by verbal orders ("VO") to stabilize the patient. While in the recovery room, Patient H.H. was intubated, on a respirator. Petitioner's witnesses, Doris Gutierrez, confirmed Respondent's monitoring of Patient H.H. when she testified that she called Respondent several times to provide updates on Patient H.H.'s condition. The record demonstrates that postoperatively on March 6, 1998, Respondent wrote his initial order to the nursing staff at 12:30 p.m. while sitting in post-surgical recovery with Patient H.H. Thereafter, Respondent continued to monitor Patient H.H.'s condition and remained in communication with the nursing staff and wrote orders at 1:30 p.m., 2:30 p.m., 3:25 p.m., 5:00 p.m., 5:15 p.m., 8:15 p.m., and again on March 7, 1998 at 12:24 a.m. Following his TO on March 7, 1998, at 12:24 a.m., Respondent next saw Patient H.H. 7 1/2 hours later, at 8:00 a.m., prior to taking Patient H.H. to the surgery room to perform the endarterectomy and embolectomy. Ms. Gutierrez testified that she does not always note when the doctor comes back into the recovery room to give orders. She could not testify as to events that took place after Patient H.H. was transferred to the Surgical Intensive Care Unit ("SICU"). She also stated she did not know how many times Respondent went to SICU because she did not work in SICU when Patient H.H. was transferred out of the recovery room. Ms. Gutierrez was also unable to testify as to when the last time was that Respondent came to the recovery room. Respondent testified that there is a difference between a TO and a VO, the latter indicating that the physician was present in the room at the time he gave his order to the nurse. The evidence is not clear and convincing that Respondent did not provide appropriate postoperative monitoring of Patient H.H.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine: Enter a final order dismissing with prejudice the Administrative Complaint filed against Respondent in DOAH Case No. 01-4406PL, and DOH Case No. 1994-12341. Enter a final order dismissing with prejudice the Administrative Complaint filed against Respondent in DOAH Case No. 01-4407PL, and DOH Case No. 1999-57795. DONE AND ENTERED this 8th day of August, 2002, in Tallahassee, Leon County, Florida. DANIEL M. KILBRIDE 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 8th day of August, 2002. COPIES FURNISHED: William R. Huseman, Esquire Romualdo C. Marquinez, Esquire Huseman, Marquinez & Schlegal, P.A. 6320 St. Augustine Road, Building 12 Jacksonville, Florida 32217 Kim Kluck, Esquire Richard J. Shoop, Esquire Agency for Health Care Administration Post Office Box 14229, Mail Stop 39A Tallahassee, Florida 32317-4229 Dr. John O. Agwunobi, Secretary Department of Health 4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701 William W. Large, 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 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
Findings Of Fact Dr. Jose A. Mijares is a general and thoracic surgeon who has practiced medicine in Tampa, Florida since 1967. He received his medical degree from the University of Havana in 1943. He served a five-year residency at Tampa General Hospital which was completed in 1967. He is Board certified in general surgery and limits his practice to that field. He is licensed to practice medicine in Florida and was so licensed at all relevant times herein. (Testimony of Respondent, stipulation) In 1977, Respondent was on the staffs of five hospitals in the Tampa area, including Centro Asturiano Hospital. The allegations of the Administrative Complaints deal with Respondent's treatment of six patients at Centro Asturiano Hospital at various times during the period 1977 to 1979. Ricardo Larzabal This sixteen-year-old patient was admitted to the hospital by Dr. A.B. Perez on May 12, 1977, with a diagnosis of abdominal pain and nausea. At admission, the patient's white blood count was slightly elevated at 11,000, but was at a normal range of 10,500 the following day. Respondent was called in for consultation on May 13. His impression was abdominal pain with possible appendical colic, and recommended a barium enema. The results of the barium enema showed that only about on-third of the appendix filled. On May 16, Respondent performed an exploratory laparotomy and appendectomy. He found the appendix kinked with a band in the proximal third of the appendix and fecalith in the distal two-thirds of the appendix. The pathological report reflected a congested vermiform appendix with lymphoid hyperplasia. Respondent's discharge diagnosis was "Abdominal pains. Appendical colic due to fecalith in the appendix. Chronic appendicitis." (Testimony of Respondent, Petitioner's Exhibit 4) Vivian Morejon Dr. C. Castellanos admitted this seventeen-year-old patient to the hospital on May 15, 1977, with a diagnosis of epigastric pain and colitis. On admission, the patient had a normal white blood county of 9,000. A barium enema was administered and reflected no abnormality. Respondent was called in for consultation on May 18 and his impression was "Abdominal pain, appendical colic." He performed an exploratory laparatomy and appendectomy on May 19, at which time he found blood in the peritoneal cavity caused by a ruptured follicle of an ovary. The appendix was retrocecal and covered by adhesions as in chronic appendicitis. His final diagnosis was "Abdominal pain, appendical colic due to chronic appendicitis, and ruptured follicle of the right ovary." The pathology report reflected that the patient had a vermiform appendix with lymphoid hyperplasia. (Testimony of Respondent, Petitioner's Exhibit 7) Ramiro Companioni, Jr. This fourteen-year-old patient was admitted to the hospital by Dr. C. Castellanos on September 24, 1977, due to pain in the right lower quadrant which had not been relieved with medication, and vomiting for two days prior to admission. The patient had been admitted to the hospital during the previous February with the same condition. At time of admission, he had a white blood count of 5,200 which was slightly lower than normal. Respondent was consulted on the day of admission and his impression was abdominal pain, appendical colic. A barium enema was ordered, but the appendix could not be observed. On September 27, Respondent performed an exploratory laparatomy and appendectomy. He found that the appendix was congested, edematous with fecalith in mid-portion covered by adhesions. The pathology report showed a microscopic diagnosis of acute appendicitis, as did Respondent's discharge diagnosis. The patient recovered without complications. (Testimony of Respondent, Petitioner's Exhibit 6) Shirley Alvarez This fifteen-year-old patient was admitted to the hospital by Dr. C. Castellanos on September 26, 1977, with acute abdominal pain in the right side with nausea and vomiting, which was diagnosed as possible appendicitis. Her white blood count was 6,900 and a barium enema did not visualize the appendix. Respondent was consulted on September 28, and his impression was that the patient had abdominal pain, appendiceal colic. He performed an exploratory laparotomy and appendectomy on September 29. The appendix was retrocecal and covered with adhesions as in chronic appendicitis. The pathology report showed on microscopic diagnosis a vermiform appendix with multiple serosal adhesions. The patient was discharged with a final diagnosis of chronic appendicitis. (Testimony of Respondent, Petitioner's Exhibit 8) Luisa Areu This forty-two year old patient was admitted by Respondent to the hospital on July 18, 1978, complaining of abdominal pain in the right flank. On examination, Respondent's impression was cervical polyp and possible enlarged uterus. The patient had experienced an exploratory laparotomy some 10 years before, but no records were available to determine the cause or results of the operation. On July 21, 1978, Respondent performed a dilation and four quadrant biopsy of the cervix. Although no polyp was found, there was severe chronic cervicitis and the uterus on palpation was enlarged. Respondent determined that a hysterectomy was advisable due to the enlargement of the uterus and the advanced severe chronic cervicitis. On July 27, Respondent removed the uterus, both fallopian tubes, and the appendix. The ovaries were not removed. The uterus was found to be of normal size, but both tubes were congested and edematous as in salpingitis. The pathology report confirmed the diagnosis of chronic cervicitis but found no significant abnormalities with the patient's tubes or appendix. Respondent's discharge diagnosis was severe chronic cervicitis. His discharge summary stated that in spite of the pathological report that the tubes looked normal, both tubes were congested and edematous like chronic salpingitis. (Testimony of Respondent, Petitioner's Exhibit 1) Deborah Fisher This 22-year-old patient was admitted by Respondent to the hospital on February 4, 1979, complaining of lower abdominal pain. Approximately seven months prior to her admission, she had had a tubal ligation and had experienced pain and occasional vomiting thereafter. The patient's history indicated that intercourse was very painful and that she had not had menstrual periods since September, 1978. Respondent's impression was "lower abdominal pain, rule out chronic pelvic inflammatory disease." All laboratory and other tests of the patient were negative. On February 8, 1979, Respondent performed a total abdominal hysterectomy, bilateral salpingectomy, and appendectomy. He found the tubes to be congested and edematous as in sub-acute salpingitis. The pathology report on microscopic diagnosis showed chronic cervicitis, mild with reserve call hyperplasia and slight dysplasia. No patholgoical diagnosis was found as to the fallopian tubes and appendix. (Testimony of Respondent, Petitioner's Exhibit 2, Respondent's Exhibit 1) It is difficult to diagnose acute appendicitis, particularly in the case of children between 12 and 18 years of age. About 70% to 85% of appendices removed incident to an operating diagnosis of appendicitis are pathologically acute. This generally is because physicians are reluctant to permit the possibility of appendices developing abscesses and perforations if appendectomies are forestalled for too long a period. It is particularly difficult to diagnose acute appendicitis in females between the ages of 14 and 18 because they often have other causes for pain, such as an ovarian cyst. It is an accepted and customary practice to remove a normal appendix in conjunction with other surgery in the right lower quadrant, unless there are contra- indicating problems. This precludes the later possibility of appendicitis attacks, and also lessens the probability of erroneous diagnosis later because of the presence of a lower incision scar. (Testimony of Myers, [Deposition- Respondent's Exhibit 4], Mason [Deposition-Respondent's Exhibit 5] Respondent) In cases that are difficult to diagnose, particularly in young children, the use of the barium enema as a diagnostic tool for appendicitis is accepted medical practice. It helps to determine if an appendix is normal. If the appendix fills completely, it is considered to be normal, but if it does not fill normally and there is also swelling and other complaints, a physician can imply pathology in the area near the appendix. (Testimony of Respondent, Myers, Ferris, Respondent's Composite Exhibit 2, 4) Expert testimony at the hearing established that all six of the operations in question were necessary and proper, and that the care and treatment rendered by Respondent to the patients met acceptable and medical standards in the community. In the case of patient Larrabal, although his white blood count had subsided on the second day of admission, his prior history, coupled with the fact that the barium enema only partially filled the appendix, showed, in the opinion of one expert, that there was a "diagnostic dilemma" which justified the operation after waiting an appropriate time. Although the pathology report reflected a normal appendix, the fact that lymphoid hyperplasia was also found indicated the presence of an abnormality. As to patient Companioni, Respondent testified that he saw no need to operate immediately because the white blood count was normal which could have indicated the presence of viral rather than bacterial infection. Again, however, the barium enema only partially filled the appendix, thus justifying the operation when considered along with the patient's complaints and other indications. Expert opinion established that Respondent's delay was justified in waiting an appropriate time to determine if the patient's illness was minor in nature or acute. The exploratory laparotomy which Respondent performed on patient Morejon was justified in that it was impossible to determine in advance whether the pain she had experienced was caused by appendicitis or something else. It was discovered upon operating that she had had a ruptured follicle of the ovary which was the source of pain. The removal of her normal appendix as incident to the surgery was necessary and proper under the circumstances. Even Petitioner's expert testified that it had been a "close call" as to whether or not to operate on the patient, and he agreed that the appendix should have been removed as incidental to the surgery. As to patient Alvarez, the fact that the appendix didn't "visualize" as a result of the barium enema indicated something was blocking the appendix and warranted the operation. The fact that fibrous adhesions were found showed that the appendix was abnormal. Although Petitioner's expert, Dr. Charles F. James, testified that the presence of adhesions indicated that the patient had probably had previous attacks of appendicitis, he felt that the operation was unjustified because there was no acute inflammation. However, he acknowledged that it is common to remove an appendix in such a case and could not be considered improper. (Testimony of Respondent, Myers, Mason, James, Respondent's Exhibit 4, 5) Petitioner's expert had reviewed the records of 15 appendectomy cases of Respondent, including the four which are the subject of charges herein. He testified that, although his opinion might be different from that of Respondent as to the treatment in question, none of the cases justified disciplinary action. (Testimony of James) There was conflicting expert testimony at the hearing with regard to the property and necessity of Respondent's surgical procedures regarding patients Area and Fisher, but the opinions expressed in the testimony of Dr. Robert W. Withers are accepted. He found that patient Areu's complaints, past medical history, and the fact that a sonogram reflected that she had an enlarged uterus indicated that the only reasonable location for her pain was in the uterus. It was therefore his opinion that such pain related to the uterus is best cured in someone who has had previous surgery in that area by the surgical procedures performed by Respondent. As to patient Fisher, similar surgical procedures performed by Respondent. As to patient Fisher, similar surgical procedures performed by Respondent were considered indicated and proper by Dr. Withers based on the patient's complaints and the prior history of tubal ligation which had resulted in the existence of post-tubal sterilization syndrome. In the opinion of Dr. Withers, there could be no other effective treatment for the patient to relieve her problem than the surgical procedures employed by Respondent. Additionally, it was found that the patient had a precancerous condition known as dysplasia, indicative that Respondent's operative procedures were fortuitous and to the patient's benefit. (Testimony of Respondent, Withers)
Recommendation That Petitioner dismiss the Administrative Complaints herein. DONE AND ENTERED this 3rd day of February, 1983, in Tallahassee, Florida. THOMAS C. OLDHAM Hearing Officer Division of Administrative Hearings 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 3rd day of February, 1983. COPIES FURNISHED: Grover C. Freeman, Esquire Freeman and Lopez, P.A. 4600 West Cypress, Suite 410 Tampa, Florida 33607 Tony Cunningham, Esquire Wagner, Cunningham, Vaughan and McLaughlin, P.A. 708 Jackson Street Tampa, Florida 33602 Dorothy Faircloth, Executive Director Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301 ================================================================= AGENCY FINAL ORDER ================================================================= BEFORE THE BOARD OF MEDICAL EXAMINERS DEPARTMENT OF PROFESSIONAL REGULATION, BOARD OF MEDICAL EXAMINERS, Petitioner, vs. CASE NOS. 81-3183 82-823 JOSE A. MIJARES, M.D., License Number: 12114, Respondent. /
