The Issue The issue in this case is whether Respondent, Cesar Augusto Lara, M.D., should be disciplined on charges alleged in the Administrative Complaint filed by Petitioner, the Department of Health (DOH), in DOH Case No. 96-12965. Essentially, the charges are that Respondent practiced medicine below acceptable standards after receiving a questionable chest X-ray on a patient on November 17, 1994.
Findings Of Fact Respondent is a Florida licensed physician, having been issued license number ME 0060883. He has been licensed to practice medicine in the State of Florida since 1991. Respondent is board certified in family practice. He maintains a private office practice in Clearwater. He is well-respected and has never been disciplined by the Florida Board of Medicine. This case concerns Respondent's care and treatment of patient D.G. After leaving the care of Respondent, D.G. was diagnosed with lung cancer. The patient died of the disease in August 1995, before having given any sworn testimony or statement regarding Respondent's care and treatment. Respondent began providing medical care to D.G. for upper respiratory problems in January 1994. She had a history of smoking and told Respondent that she had just quit. Some time later, D.G. presented to Respondent with complaints of swelling in the left hand and an inability to move her thumb. Respondent attempted conservative treatment of D.G.’s left hand and thumb; but when her condition did not improve, Respondent referred her to an orthopedic surgeon, Dr. Michael Rothberg, on March 31, 1994. Following referral to Dr. Rothberg, Respondent continued to serve as D.G.’s primary care physician, taking care of other problems unrelated to her left hand and thumb. On November 3, 1994, Dr. Rothberg had D.G. return to Respondent to obtain surgical clearance for surgery on her hand to be performed under regional block anesthesia on November 29, 1994. Dr. Rothberg specifically requested that Respondent include the following laboratory (lab) studies as part of the surgical clearance: CBC and SMAC routine blood studies; urinalysis; and an EKG. Respondent saw the patient for surgical clearance on November 14, 1994. Respondent conducted a physical examination and ordered the laboratory studies requested by Dr. Rothberg. In addition, Respondent decided to get a chest X-ray as part of his surgical clearance. Based on his physical examination of the patient, Respondent found D.G. to be generally healthy without any respiratory symptoms or contraindications for surgery. Pending receipt of the lab results, Respondent felt that D.G. could undergo the planned surgery by Dr. Rothberg; he did not anticipate lab results that would contraindicate the planned surgery. Respondent dictated a report to that effect in the patient's presence in the examination room. The typed dictation was initialed by Respondent two days later, on November 16, 1994. Respondent testified that, at the conclusion of the office visit on November 14, 1994, he requested that D.G. return to his office in 4-to-6 weeks for follow-up. Petitioner questioned Respondent's sworn testimony on the ground that there was no documentation in the medical record supporting it. But it was Respondent's routine practice to have patients return to his office following surgery so that he could follow the recovery of his patients from the surgery. In addition, Respondent marked an "encounter form" to indicate his desire for D.G. to return to the office for follow-up in 4-to-6 weeks. An "encounter form" is a common communication tool between a physician and his office staff. It provides a means by which the patient is billed for the services provided. It also provides the staff with direction on scheduling patients for return or follow-up visits. The patient presents the encounter form to Respondent's office staff on the way out of the office. Necessary patient payments are made, and the next appointment is scheduled. The office then utilizes the form to secure third-party payments. Petitioner suggested that the encounter form in evidence as Respondent's Exhibit 2 was fabricated on the ground that Respondent did not produce it until a short time before final hearing. Respondent denied the suggestion, explaining that he did not look for it at first because he did not realize how important it was. Respondent's testimony is accepted, and the suggestion of fabrication is rejected. Should the patient refuse the appointment requested by Respondent on an encounter form, or wish to call back and schedule it later, Respondent's office staff routinely would make a notation on the form indicating that the appointment was not scheduled or that the patient would call to schedule. In this case, no such notations were made on the form. Based on routine office practice, the absence of any such notation would signify, in all probability, that D.G. was given a follow-up appointment in the requested time frame before she left Respondent's office, that the appointment was entered in Respondent's computer, and that D.G. was given a card indicating the date of her appointment. By the time of the hearing, there was no way to verify D.G.'s follow-up appointment using Respondent's office computer. Some time in 1998, Respondent switched his office computer system. The new system does not have appointment information going back to 1994, and the old system with old appointment information was not retained. Two days later, on November 16, 1994, Respondent received an imaging report of D.G.'s chest X-ray. The radiologist reported questionable slight prominence of left hilar region, inferiorly, on the posterior-anterior view. On lateral view, no definitive density could be discerned. The radiologist suggested that comparison with old films would be helpful; if old films were not available, he recommended CT examination. Respondent initialed the radiologist's report the next day, November 17, 1994. Respondent testified that it was his routine practice to initial such a report when he reviewed it. He testified that he decided not to withdraw surgical clearance based on the report. Petitioner questioned Respondent's testimony on the ground that there is no medical record documenting Respondent's decision, other than Respondent's dated initials on the imaging report. But Respondent's testimony in this regard is accepted, and Petitioner's suggestion that Respondent was not even aware of the content of the report is rejected. Respondent's medical record on D.G.'s medical record contains no other information until a pharmacist telephoned Respondent's office on January 18, 1995, to ask Respondent to authorize refilling a prescription for erythromycin. Respondent had his office relay to the pharmacist that Respondent would not authorize refilling the prescription unless Respondent saw the patient in his office. Respondent did not mention the missed appointment or questionable X-ray to the pharmacist, and D.G. never called for an appointment. On or about March 14, 1995, D.G. presented to another physician, Dr. Christopher Purcell, complaining of a five-day cough, pain in the left scapular region, and congestion and wheezing. There was no indication in Dr. Purcell's record that D.G. mentioned the questionable imaging report dated November 16, 1994. (Dr. Purcell did not testify.) On April 11, 1995, Dr. Purcell received D.G.'s medical records from Respondent's office, including the imaging report dated November 16, 1994. Dr. Purcell immediately ordered a repeat X-ray and referred D.G. for a consultation with a specialist on the same day. Not long after, D.G. was diagnosed with lung cancer. She died on August 10, 1995, from squamous cell lung cancer with metastasis to the thoracic spine. Notwithstanding the absence of any medical records between Respondent's dated initials on the imaging report on November 17, 1994, and January 18, 1995, Respondent testified to a clear recollection of discussing the report with D.G. He testified that he told her they would have to follow-up and resolve the questionable findings but that it could wait until follow-up after her planned surgery. Respondent testified that, for reasons unknown to him, D.G. canceled her follow-up appointment, never rescheduled, and never returned. There was no documentary evidence of D.G.'s canceled appointment, but the evidence was that no such evidence would exist except for cancellations or "no-shows" on the day of an appointment, in which case there would be a notation on a daily appointment sheet. For cancellations prior to the day of an appointment, the appointment would be erased from the calendar so the appointment time could be used for another patient. At the time, Respondent had no system in place for contacting patients who canceled an appointment without rescheduling. Now, after commencement of a lawsuit against him on the facts of this case, Respondent has instituted a "911" system of flagging patients whose medical condition requires the rescheduling of canceled or missed appointments. Petitioner contends that the evidence was clear and convincing that Respondent did not advise D.G. of the results of her chest X-ray or any plan for follow-up, notwithstanding Respondent's testimony that he did. Petitioner not only points to the suspicious absence of medical records (in contrast to Respondent's otherwise complete and accurate medical records) but also points out the patient's history of general good compliance with Respondent's orders and her failure to tell either her husband or Dr. Purcell about the questionable imaging report dated November 16, 1994. As for the absence of medical records, it was Respondent's routine practice upon receipt of a questionable X- ray or other lab report to ask for the patient's file and telephone the patient. Then, depending on the nature of the report and the patient involved, Respondent either would discuss the report and a plan for follow-up on the telephone or arrange for an appointment to discuss those matters in person in Respondent's office. If Respondent discussed the matter on the telephone, he normally would document the telephone call and the plan in the patient's medical record. However, it is possible that Respondent made the call to D.G. from outside the office without having her medical record available; it also is possible that he had to leave a message for D.G. and that her medical record was not readily available to him when she returned the call. Either scenario could have led to Respondent's failure to make a record of his telephone call to D.G. Respondent concedes that D.G. was a compliant patient who generally followed his orders and recommendations. She was interested and concerned about health issues affecting her and would not be inclined to ignore medical advice on them. But changes in Respondent's relationship with D.G.'s health care plan--PruCare--could explain why D.G. did not keep her follow-up appointment with Respondent. It was public knowledge that PruCare was terminating its contracts with several area physicians including Respondent, effective January 1, 1995. Respondent gave written notification of these events to his PruCare patients. PruCare also notified its insureds. Both the terminated physicians and PruCare placed advertisements in local newspapers asserting the merits of their positions in the dispute that arose from the termination. Newspaper articles also were published on the issue. It is highly probable that D.G. became aware of the contract termination in one way or another. As a result of the contract termination, PruCare would not cover visits to Respondent after January 1, 1995. Most PruCare patients changed primary care physicians to keep the financial benefit of their PruCare policies. It is possible that D.G.'s follow-up appointment was scheduled for just after the first of the year and that she called to cancel, anticipating following up with a new PruCare-approved primary care physician. Even if the follow-up appointment was scheduled for December 1994, it is quite conceivable that D.G. canceled it in the same anticipation. Normally, D.G. would discuss her health concerns with her husband. But her husband also testified that she did not discuss everything with him. Specifically, he had no knowledge that she was having a chest X-ray taken prior to her hand surgery. Nor did he know the specifics of any of the lab studies done for Respondent's clearance for surgery. It is more difficult to explain the patient's apparent failure to mention the questionable imaging report to Dr. Purcell on March 14, 1995 (based on the absence of any medical record documenting such a disclosure to him.) Assuming completeness of Dr. Purcell's medical records, it could well be that Respondent did not impress on D.G. the possible significance of the findings during his telephone conversation with her after review of the imaging report. He might not have seen the need to do so prior to the follow-up appointment he was anticipating. He also might not have wanted to so as not to unnecessarily complicate the impending hand surgery by making the patient overly anxious about the imaging report and what it could signify. Taking all of the evidence into consideration, it is found that Petitioner did not prove by clear and convincing evidence Respondent's alleged failure to advise D.G. of the results of her chest X-ray or any plan for follow-up. Besides Respondent, three physicians testified as experts in this case. All agree that the "level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances" (the "standard of care") required Respondent to notify the patient to discuss the report and a plan of follow-up, which could include: physical examination; review of older X- rays (to determine if there was a change between X-rays); a repeat X-ray; a CT study (for a clearer image than an X-ray); and referral to a specialist. The disagreements among the experts centered on the urgency of follow-up and the assumed facts. Respondent's two experts accepted the veracity of Respondent's testimony that Respondent discussed with the patient the imaging report and his plan for follow-up at the appointment scheduled for follow-up for the hand surgery. Petitioner's expert assumed the contrary. Petitioner's expert testified that it was incumbent on Respondent to follow-up within 24-48 hours. But it was not clear from his testimony if "follow-up" in this context meant anything other than notification to the patient and discussion of a plan for timely follow-up. If so, Petitioner's expert was at odds with the other experts, all of whom clearly testified to their opinions that the other means of follow-up could be accomplished within anywhere from two weeks to two months. (As for physical examination, Respondent already had examined the patient on November 14, 1994, and there were no symptoms. As for review of older X-rays, the only previous X-ray was from 1989, and Respondent testified to his opinion that simply reviewing an X-ray that old would not meet the "standard of care.") Respondent and his experts placed responsibility on the patient to follow her doctor's recommendations. They did not think the "standard of care" required Respondent to contact D.G. to remind her, much less require her, to reschedule her appointment. In all probability, D.G. would have rescheduled but for PruCare's cancellation of its contract with Respondent. Through a combination of circumstances for which they did not think Respondent should be held responsible, the patient did not reschedule her appointment and was "lost to follow-up" by Respondent. Based on the pertinent factual findings and the expert testimony, Petitioner did not prove by clear and convincing evidence that Respondent practiced medicine below the "standard of care." Petitioner also suggested that Respondent was at fault for not directing D.G. to a particular primary care physician for medical care after January 1, 1995. But Respondent and his staff testified that PruCare did not make Respondent aware of his patients' options for primary care after the contract termination. There was no evidence to dispute their testimony to that effect. Nor was there any evidence that the "standard of care" required Respondent to direct D.G. to a particular primary care physician for medical care after January 1, 1995. Finally, Petitioner suggested that Respondent had an obligation to follow-up on the missed appointment when the pharmacist telephoned on January 18, 1995. Petitioner's argument would have been stronger had the patient telephoned instead of the pharmacist. As it was, the evidence was not clear and convincing that a telephone call from a pharmacist should have triggered the realization that D.G. had missed her follow-up appointment. In addition, there was no evidence that the "standard of care" required Respondent to follow-up on the missed appointment at that point. Besides, it would have been reasonable for Respondent to assume at that point that D.G. probably would not return to him but would see a new primary care physician contracted to PruCare under the patient's health care plan. Clearly, early detection and treatment of cancer is important. But, while not particularly relevant to the question of whether Respondent practiced within the "standard of care," it is noted that all of the physicians testifying as experts agreed that the outcome probably would not have been different had D.G.'s cancer been diagnosed in November 1994. Unfortunately, lung cancer is difficult to detect; when detected, it usually is beyond cure, and death usually follows relatively soon thereafter.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding Respondent not guilty. DONE AND ENTERED this 17th day of July, 2000, in Tallahassee, Leon County, Florida. J. LAWRENCE JOHNSTON 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 17th day of July, 2000. COPIES FURNISHED: Britt Thomas, Esquire Laudelina McDonald, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Jon M. Pellett, Esquire Freeman, Hunter & Maloy 201 East Kennedy Boulevard, Suite 1950 Tampa, Florida 33602 Angela T. Hall, Agency Clerk Department of Health Bin A02 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1703 William W. Large, General Counsel Department of Health 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0750
The Issue The issue is whether Respondent failed to practice medicine with the required standard of care, in violation of Section 458.331(1)(t), Florida Statutes, and failed to keep required written medical records, in violation of Section 458.331(1)(m), Florida Statutes. If so, an additional issue is what penalty should be imposed.
Findings Of Fact At all material times, Respondent has been a licensed physician in Florida, having been issued license number ME 0022608. Respondent is board-certified in ophthalmology. He was the principal investigator in the Excimer Laser Research Study. He is a fellow with the American College of Surgeons. He has published extensively in prominent medical and ophthalmologic journals. While still receiving medical training, Respondent gained experience in treating the ophthalmologic conditions of patients who suffer from Down Syndrome. While in practice, Respondent has continued to gain considerable experience in treating the ophthalmologic conditions of patients with Down Syndrome. Respondent has never previously been disciplined. U. V. was born on January 6, 1973. He suffered from Down Syndrome. As a young child, U. V. was diagnosed with inoperable congestive heart failure. Suffering from damage to two chambers of his heart and irreversible lung damage, U. V. had been in “terminal” condition since about the age of seven. Despite his serious medical problems, which are common to Down Syndrome patients, U. V. was a happy young man, who developed and matured as a teenager. He communicated his feelings and interacted with others, especially with his family. His mother adopted him when he was about five years old; previously, she had cared for him after his biological family had abandoned him. In March 1992, U. V. became quite ill. His physician discussed with U. V.’s mother the possibility of a Do Not Resuscitate order, but no order was ever given or entered into his medical records. U. V. rallied from his illness. His cardiologist found, after an office visit on October 13, 1992, that U. V. had made “tremendous progress” and was “doing quite well at this point in time.” This was the last time that U. V. visited his personal physician prior to the cataract surgery nearly a year later. In April of 1993, U. V. received home health care through the Hospices of Palm Beach. During this time, the hospice nurse who visited U. V. at home noted that he was sensitive about his Down Syndrome and social isolation. On July 14, 1993, the hospice nurse noted that she found U. V. to be “alert, ambulatory, cheerful.” U. V.’s mother told the nurse that U. V. wanted an eye surgeon to treat a cataract that had developed in his left eye, and the family would be willing to pay for the operation in installments, if health coverage would not pay for the surgery. Ten days later, during another home visit by the hospice nurse, U. V.’s mother again stated her concern about his cataract. The nurse told her to take U. V. to his primary care physician for a referral. U. V.’s family took U. V. to his family physician, who sent him to an optometrist. The optometrist determined that U. V. had a cataract in his left eye and was starting to develop one in his right eye too. The optometrist told them that surgery could correct the condition and referred U. V. to Respondent. About a month later, in late August, U. V.’s mother informed the hospice nurse that they had an appointment with an eye surgeon and hoped that he would remove the cataract from U. V.’s left eye. At this time, U. V. was still leading an active life, largely due to the support and assistance of his loving family. He was happy and enjoyed dancing at weddings and parties and watching television. The family thought that surgery would help him see better with his left eye. Respondent first examined U. V. on August 31, 1993. He found a hypermature cataract in U. V.’s left eye. U. V.’s eye was totally opacified by the cataract to such an extent that he could see only hand motion. Respondent was immediately concerned with the possibility of phacolytic glaucoma. This is a condition in which the cataract liquifies and may leak through the lens capsule, resulting in an immunological reaction. Phacolytic glaucoma is extremely painful. It is impossible to predict the precise onset of phacolytic glaucoma, but Respondent reasonably determined that the condition could develop in as little time as hours or days, although it was possibly months away. Respondent was also concerned with U. V.’s right eye. Respondent found a cataract in the right eye in the lens where all the light rays pass into the eye. This type of cataract advances rapidly, so much so that it might overtake in seriousness the older cataract in U. V.’s left eye. Respondent performed a comprehensive examination of both eyes. He discussed cataract surgery with U. V.’s mother. Respondent agreed to perform the surgery for the Medicaid payment. He carefully explained the condition of U. V.’s left eye and the risks and benefits of surgery and general anesthesia. To assist in communicating with U. V.’s Spanish-speaking mother, Respondent had someone in the office translate for the mother. After hearing the explanation, U. V.’s mother agreed to the surgery, and Respondent set up the surgery for September 7, 1993. After returning home, U. V. began complaining of problems with his right eye. His sight was deteriorating at this time, heightening his feeling of isolation from the world around him. In the meantime, Respondent had the laboratory work done in preparation for the surgery. His office contacted U. V.’s physicians to get medical information in preparation for the cataract surgery. But they were unable to get such information from the physicians’ offices. On September 7, U. V. and his family returned to Ft. Myers for the surgery. The board-certified anesthesiologist examined U. V. and found that he had wheezing respiration, so the anesthesiologist told Respondent that the surgery had to be postponed. Respondent rescheduled the surgery for September 15, 1993. Respondent and the anesthesiologist then discussed the possibility of using a local anesthetic, which would present fewer risks to U. V. than would be posed by a general anesthetic. But, as is typical with Down patients, U. V. had been fidgety during the August 31 office visit and was a poor candidate for local anesthesia during the extremely delicate cataract surgery that he was about to undergo. Respondent and the anesthesiologist agreed that U. V. would receive general anesthesia for the surgery. After the first surgery was canceled, the anesthesiologist undertook the task of obtaining the medical clearances for general anesthesia. He spoke with U. V.’s primary physician, who practices in the small town where U. V. lived at the south end of Lake Okeechobee between Clewiston and Belle Glade. U. V.’s primary physician appeared as a witness at the hearing. He seemed to suffer from communication problems not entirely attributable to obvious difficulties with the English language. Not surprisingly, the anesthesiologist obtained little useful information from the physician. The anesthesiologist’s nurse called the cardiologist’s office several times on September 15 prior to the surgery. Unable to reach the cardiologist or any of his partners, the anesthesiologist spoke with one of the cardiologist’s office nurses and had her read him U. V.’s chart. Especially interested in U. V.’s cardiac malformations, the anesthesiologist satisfied himself that U. V. could withstand the rigors of general anesthesia and developed a plan, after discussing the case with his partners, to use special drugs and techniques so as to affect V.’s heart and lungs as little as possible. The anesthesiologist also studied either a chest xray taken on September 6, 1993, or a report of the chest xray taken on that date. He examined the xray or report to determine if U. was suffering from any reversible heart problems that might resolve themselves if surgery were postponed. The anesthesiologist found no cardiac problems of this type. Prior to the administration of the general anesthesia, the anesthesiologist spent several hours with U. V. and his family discussing the risks and benefits of general anesthesia. U. V.’s mother accepted the risks and agreed to the use of the general anesthesia. U. V.’s cardiologist testified that, if asked about the surgery and general anesthesia, he would have cautioned Respondent and the anesthesiologist of the risks of surgery, but he would not have offered an opinion on the advisability of using general anesthesia on U. V. The cardiologist would have left the decision on this matter to the anesthesiologist. On September 15, 1993, Respondent removed the cardiac from U. V.’s left eye. The surgery was flawless. During the surgery, U. V. was stable and tolerated the anesthesia. Following the surgery, U. V. awoke in the recovery room, where he was alert and following commands. Once U. V. began to breathe better on his own, the ventilator machine was turned off. U. V. suddenly developed cardiac arrhythmia and died within an hour. Respondent did not deviate from the applicable standard of care in his diagnosis and treatment of U. V. Respondent’s medical records amply memorialize his diagnosis and fully justify the surgery undertaken on September 15, 1993.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order dismissing the administrative complaint against Respondent. ENTERED in Tallahassee, Florida, on June 4, 1997. ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings on June 4, 1997. COPIES FURNISHED: Britt Thomas, Senior Attorney Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 John F. Lauro, Esquire John F. Lauro, P.A. Suite 3950 101 East Kennedy Boulevard Tampa, Florida 33602 Dr. Marm Harris Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0972 Jerome Hoffman, Esquire Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308-5403
The Issue Whether Respondent, a physician, committed the offenses alleged in the Administrative Complaint and the penalties, if any, that should be imposed.
Findings Of Fact At all times pertinent to this proceeding, Respondent was a licensed physician in the State of Florida (license number ME 0031217) who practiced in the specialty of orthopedic surgery. Respondent was not board certified. At all times pertinent to this proceeding, Respondent had hospital privileges at Palm Springs General Hospital (Palm Springs) in Hialeah, Florida. On Saturday, February 26, 1994, T. P., a 29 year-old male, suffered a badly fractured leg while playing soccer. T. P. was taken to the emergency room at Palm Springs where the emergency room physician partially reduced the angulation of the fracture and placed the patient's leg in a splint cast. The patient was thereafter admitted to Palm Springs on February 26, 1994, under the care of Dr. Stephen Ticktin, an orthopedic surgeon. X-rays revealed that the patient had sustained a jagged fracture of both the tibia and the fibula. The fractures were similar to sharp-edged spears. There was a laceration and significant bruising at the fracture sight. Dr. Ticktin examined the patient's leg on February 26, 1994, but did not reduce the fracture (set the leg) on that date. Instead, Dr. Ticktin kept the leg in the splint cast to immobilize it, and planned to perform surgery on the following Monday morning. The patient and his girlfriend told Dr. Ticktin that they did not want to have surgery at Palm Springs. They wanted the patient transferred to a Broward County hospital so that he could be closer to his residence. On Monday, February 28, 1994, Dr. Ticktin did not perform surgery on T. P. On Monday, February 28, 1994, T. P. changed his mind and agreed to have surgery at Palm Springs. (Dr. Ticktin's notes reflect that the patient changed his mind after talking to a representative of his insurance company.) Surgery was planned for Wednesday, March 2, 1994. On that Wednesday, the patient ran a fever. Because of that fever, the anesthesiologist cancelled the surgery that had been scheduled for March 2, 1994. The patient terminated the services of Dr. Ticktin on March 2, 1994, and refused to be treated by him. Late in the day of Wednesday, March 2, 1994, the hospital administrator asked Respondent to assume the care of the patient. Respondent first saw the patient between 10:00 p.m. and 11:00 p.m. on Wednesday, March 2, 1994. At the time Respondent first saw him, T. P. had been immobile with the cast that Dr. Ticktin had placed on his leg on February 26, 1994. His fractured leg had not been set. The patient was very upset. On the evening of March 2, 1994, Respondent determined that the fracture would have to be reduced with the patient being under general anesthesia. Respondent observed that the leg did not appear to be excessively swollen and that the circulation in the leg was appropriate. Respondent noted that there was numbness in the foot, which indicated that a peritoneal nerve had been injured. Respondent had no reason to believe that that the patient was suffering from a compartment syndrome on March 2, 1994. Compartment syndrome is a relatively rare occurrence that results in restricted or total loss of blood flow due to swelling within a compartment, which is an enclosed facia. The tibia and fibula are encased in a compartment from the knee to the ankle. Swelling within that compartment produces pressure on the arteries and smaller blood vessels that can restrict or completely block the flow of blood below the area of the swelling. It typically takes several hours or days for a compartment syndrome to manifest itself. On the morning of March 3, 1994, Respondent aligned T. P.'s leg, thereby reducing the fractures, and stabilized it by inserting pins in the leg and applying an external fixater attached above and below the fracture sites. At approximately 10:00 a.m. on March 3, 1994, the patient was moved from the operating room to the recovery room. At the time the patient left the operating room, there were no signs that anything untoward had happened. The recovery room records reflect that at approximately 10:05 a.m., there was no pulse below the fracture site. Respondent observed in the recovery room that the leg below the fracture was ischemic (receiving little or no oxygen). Respondent testified, credibly, that he considered whether the patient was suffering a compartment syndrome, but that he concluded that he probably was not because of the rapid onset of the problem following the reduction and the placing of the fixater, and because the leg remained supple and had not changed from the earlier examination. Respondent immediately ordered an angiogram, the appropriate diagnostic examination, and contacted Dr. Marcos Zequeira, a vascular surgeon on the staff of Palm Springs. Both Respondent and Dr. Zequeira were of the opinion that the patient had suffered a vascular accident and neither one formed the opinion that they were dealing with a compartment syndrome. Dr. Zequeira and Respondent agreed that an angiogram should be performed to diagnose the cause of the loss of blood flow in the leg. Dr. Zequeira advised Respondent that there were no facilities to perform an angiogram at Palm Springs. 1 Dr. Zequeira and Respondent decided to transfer the patient to Dr. Felix Freshwater, a micro-surgeon at Deering Hospital, to perform an angiogram and perform the procedure that would be necessary to resolve the problem. As soon as could be done, Dr. Zequeira contacted Dr. Freshwater, who agreed to accept the patient. Respondent thereafter immediately made the arrangements for an ambulance, which transported the patient to Deering Hospital. Respondent followed the ambulance in his own car and remained with the patient until after Dr. Freshwater performed surgery on the patient. The patient arrived at Deering Hospital at 2:00 p.m. and the angiogram was completed at 3:40 p.m. Anesthesia was started on the patient at 4:37 p.m. and surgery began at 5:30 p.m. The angiogram performed at Deering Hospital revealed that the patient had suffered a type of a compartment syndrome. It was not a typical compartment syndrome and it could not have been accurately diagnosed without the angiogram. Dr. Freshwater testified that his and Dr. Zequeira's presumptive diagnosis prior to the angiogram was that of a direct arterial injury as opposed to a compartment syndrome. Appropriate surgical intervention required an angiogram. The surgical procedure performed by Dr. Freshwater (fibulectomy-fasciotomy) restored the circulation in the patient's leg. Loss of blood flow presents a serious threat to a patient's leg and can result of the loss of the limb. The longer the blood flow is cut off, the more damage to the leg occurs. Damage can begin to occur in as little as two hours after the flow is cut off. Damage to the leg is certain if blood flow is cut off for twelve hours or longer. Here, the patient's circulation in his leg had been significantly restricted or blocked from approximately 10:05 a.m. until the surgical intervention by Dr. Freshwater. Petitioner did not establish that the patient's subsequent problems with his leg were attributable to that fact.2 Petitioner's experts opined that when he first detected that the blood flow in the leg had been compromised, Respondent should have immediately removed the fixater from the patient and, if necessary, displaced the fracture, thereby restoring the flow of blood. These witnesses, both of whom are highly qualified in their fields of practice, testified that Respondent's failure to take prompt action to restore the flow of blood was below the acceptable standard of care. Dr. Freshwater and Dr. Shall were of the opinion that Respondent did not practice below the standard of care. All experts agree that it was appropriate for Respondent to consult with Dr. Zequeira, a vascular surgeon, and to order an angiogram. All experts agree that the restricted or blocked blood flow presented a danger to the patient's leg, and all agreed that the leg would suffer more damage the longer it took to restore appropriate blood flow. Dr. Freshwater and Dr. Shall were of the opinion that removing the fixater and displacing the fractures as suggested by Petitioner's experts without an angiogram would have presented an unwarranted risk to the patient because an appropriate diagnosis had not been made (and could not have been made without an angiogram) and because moving these spear-like fractures could easily have resulted in more damage to the leg, such as cutting or puncturing an artery. The more persuasive evidence established that it was appropriate for the Respondent to transfer the patient to the care of Dr. Freshwater because Dr. Freshwater was imminently qualified to perform the delicate surgery that was thought necessary to restore the blood flow and because Deering Hospital had the facilities to perform the requisite angiogram. All of the treating physicians were aware that time was of the essence and they moved as expeditiously as circumstances and prudence permitted.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Administrative Complaint against the Respondent be dismissed. DONE AND ENTERED this 11th day of February, 1999, in Tallahassee, Leon County, Florida. CLAUDE B. ARRINGTON 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 11th day of February, 1999.
The Issue The issue is whether Respondent failed to practice medicine at the level of care, skill, and treatment that is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances and, if not, the penalty.
Findings Of Fact Respondent is a licensed physician, holding license number ME 0026784. He is Board-certified in radiology. On January 30, 1997, T. D., a 30-year-old female who was eight months pregnant, presented to the emergency room of the Columbia Largo Medical Center complaining of pain in the left flank radiating to the left groin, together with nausea and vomiting. She also reported a prior history of kidney stones. A urologist diagnosed T. D. as suffering from kidney stones and severe hydronephrosis, which is the dilation of the kidney due to an obstruction in the flow of urine. The urologist was unable to pass a stent and catheter by the stones to drain the urine and relieve the pressure on the kidney, so he asked Respondent to perform a left percutaneous nephrostomy. A percutaneous nephrostomy is a procedure in which a physician places a tube through the skin and into the collecting system of the kidney to drain the kidney. The tube remains in place until the obstruction is removed. On February 1, Respondent performed a left percutaneous nephrostomy under local anaesthesia. For guidance in placing the tube, Respondent used ultrasound, rather than ultrasound and a flouroscopy. Respondent has performed 100-150 nephrostomies. As is the common practice, he normally does not rely exclusively ultrasound in guiding the placement of the tube in the kidney. In this case, the urologist asked that he not use a flouroscopy, in deference to the patient's pregnancy and the duration of x-ray exposure in a flouroscopy. Respondent was comfortable doing the procedure in this manner, although he decided that, if he encountered any problems in placement, he would resort to flouroscopy. Respondent proceeded to perform the percutaneous nephrostomy in the morning. As is typical, the radiology technician helped position T. D. on the table for the procedure. T. D.'s advanced pregnancy necessitated a slight adjustment to the normal posture of patients being prepared for this procedure, so T. D. lay slightly more up on her side than is usual. However, this did not change the point of entry chosen by Respondent. And, regardless of her precise position, the location of the spinal canal relative to the kidney relative to the point of entry into the skin remains constant: an imaginary line from the kidney to the spinal canal is perpendicular to an imaginary line from the point of entry to the kidney. The point of entry is on the lower back of the patient. T. D. is thin and her pregnancy did not manifest itself on her back, so the length of tube used by Respondent was relatively short. T. D.'s thin build makes it less likely that Respondent would have placed sufficient excess tube into the patient so as to permit the tube to run from the kidney to the spinal cord. Upon placement of the tube, at least 100 cc of fluid drained through the tube. This is well within the range of urine that would be expected under the circumstances. The color was well within the range of color for urine. The preponderance of the evidence indicates that the fluid was urine and that Respondent had placed the tube correctly in the kidney. At the end of the procedure, T. D. appeared a lot more comfortable. Late in the afternoon, someone called Respondent and told him that the drainage had slowed to a very small amount or nothing at all. This is not uncommon, as moving the patient or over-energetic nurses may accidentally dislodge the stent in the kidney. It is also possible that the tube has rested in a part of the kidney that does not facilitate maximum drainage. Using ultrasound, Respondent confirmed that the tube remained in place in the kidney, although he could not tell whether the stent had come to rest in a narrow place in the kidney or possibly even against a stone. Even with this uncertainty, Respondent still was able to determine that the stent was predominantly in the collecting system. Because T. D. was resting comfortably, she said that she felt fine, her fever was going down, and the hydronephrosis had decreased, Respondent decided to do nothing until after re-examining T. D. the next morning. However, at about 11:00 p.m. or midnight, Respondent, who was visiting a nearby patient, dropped in on T. D. The nurse said that she was fine and her kidney was draining a little better. T. D. also said that she was feeling fine. About three or four hours later, T. D. reported a feeling of some paralysis. Petitioner's expert testified that this was linked to the misplacement of the stent in the spinal canal, but he was unaware that T. D. had undergone a spinal block for the percutaneous nephrostomy and that a problem with the first anaesthetic procedure had necessitated a second. It is more likely that T. D.'s paralysis was in response to the two spinal blocks. At 9:00 a.m. the next day, Respondent returned and examined T. D. He found that she was still doing better, and her urologist was preparing to discharge her from the hospital. She looked better, and her urine flow had improved. He told her to call him if she had any problems, but he never heard from her again or even about her until he learned from the urologist that T. D. had been admitted to another hospital where a radiologist had inserted contrast material into the tube to locate the stent and found it in the spinal canal. The father of the baby picked up T. D. at the Columbia Largo Medical Center. He picked her up out of the wheelchair and placed her in the car. Her condition deteriorated once she got home. A hospital nurse directed the father to change the collection bag, if it filled prior to the visit of the home health care nurse. In the three or four days that T. D. remained at home, he changed the bag several times. He daily checked the site at which the tube entered T. D.'s skin and noticed that it had pulled out a little bit. However, he testified that he did not try to adjust the length of tube inside T. D., nor did he change the setting on the tube, which had "open" and "closed" settings for the pigtail at the end of the tube. The proper setting was closed, as the pigtail is not to be open once the stent has reached its destination in the kidney. On February 5, the father took T. D. to the emergency room of the Columbia St. Petersburg Medical Center, where she presented with complaints of severe back pain. An ultrasound confirmed the presence of kidney stones, whose removal had been deferred until the delivery of the baby. In an effort to locate the end of the tube, a radiologist inserted radiographic contrast dye, which showed that the end of the tube was in the intrathecal space of the spine. A urologist removed the tube. However, T. D. suffered a seizure. Another physician attempted an emergency C-section, but the baby did not live. There are two alternatives to explain how the stent at the end of the tube found its way into the spinal canal. First, Respondent placed it there during the procedure. Second, it migrated from the kidney, where Respondent placed it, to the spinal canal. If not unprecedented, both alternatives are extremely rare. The drainage during the procedure and initial improvement of the distended kidney are consistent with the proper initial placement of the stent. The difficulty of inadvertently turning a relatively short length of tube 90 degrees from the kidney to the spinal canal also militates against a finding that Respondent misinserted the tube. Problems with the first spinal tap may have contributed to some of the complaints, such as paralysis, that T. D. experienced after the procedure. Although unlikely, the migration alternative would be consistent with well-intended, but incorrect, attempts by the baby's father or a home health care nurse to ensure that the tube did not travel too far in or our of the point of entry. Migration would be facilitated if either the father or nurse misread the "open" and "closed" settings and turned to "open," in the hope of improving drainage, when such a setting opens the pigtail, which would increase the possibility that the stent could migrate into the spinal canal. In a case requiring proof that is clear and convincing, it is impossible to find that Petitioner has adequately proved that Respondent misinserted the tube during the procedure. Likewise, the evidence is not clear and convincing that Respondent should have recognized at anytime prior to T. D.'s discharge from the Columbia Largo Medical Center that something was wrong with the procedure that he had performed or that he needed to confirm by x-ray the location of the stent at the end of the tube.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order dismissing the Administrative Complaint. DONE AND ENTERED this 2nd day of August, 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 2nd day of August, 1999. COPIES FURNISHED: Britt Thomas, Senior Attorney Agency for Health Care Administration Fort Knox Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308 William B. Taylor, IV Macfarlane, Ferguson & McMullen Post Office Box 1531 Tampa, Florida 33601-1531 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 Tanya Williams, Executive Director Board of Medicine Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0750
Findings Of Fact At all times material, Respondent was licensed as an osteopathic physician in the state of Florida, having been issued license number 050004170. Respondent practices in the field of general surgery, and at all times material to this action, Respondent was on staff as Chief of Surgery at the University Hospital, Holly Hill, Florida. The incident which gave rise to the charges herein arose on August 5, 1987 when Respondent inserted a chest tube into patient W.T.'s right chest wall so as to relieve a pneumothorax which had actually occurred in W.T.'s left lung. A pneumothorax is a pocket of air in the cavity surrounding the lung which causes the lung to contract upon itself. At all times material, Patient W.T. had a subcutaneous pacemaker on the left side of her chest. However, the evidence from all credible witnesses is consistent that pacemakers are routinely placed on either the right or left side and that there is no reasonable medical presumption that pacemakers are always placed in someone's left chest area. The subcutaneous pacemaker did not enter significantly into W.T.'s case management at University Hospital. It operated on "automatic" and since it did its job, none of the University Hospital physicians involved in W.T.'s care paid much attention to it. W.T. was admitted to University Hospital for treatment of a drug overdose on July 9, 1987. As a part of her treatment, an Ewald tube was inserted into her stomach by a physician other than the Respondent. Patient W.T. was discharged from the hospital on July 18, 1987 with a portion of the tube inadvertently left in her stomach and her esophagus. On July 21, 1987, W.T. was readmitted to University Hospital. She was suffering from septicemia and bilateral pneumonia. X-rays revealed that a portion of the tubing had not been removed. This tubing was removed by the Respondent via successful gastroesophagoscopy on July 23, 1987. At Respondent's order, W.T. was placed in the Intensive Care Unit (ICU) following the removal of the tube. Dr. Desai was called in as a pulmonologist. When W.T. had been admitted to University Hospital on July 21, 1987, she already had been in a "guarded" condition. Despite successful removal of the Ewald tube, W.T.'s overall condition continued to deteriorate. Prior to the night of August 4, 1987, W.T. had developed adult respiratory distress syndrome (ARDS) which involves a breakdown in the capillary barriers within the lung itself, resulting in a diffuse leakage of fluid throughout all of the air space of the patient's lung. Because of the patient's serious lung condition, Dr. Desai placed her on a volume respirator, and the respirator pressure (PEEP) was progressively increased during her admission until it was set at 20 PEEP at the time of the incident. Twenty PEEP is an unusually high level of respirator pressure which was necessary in this case because of the patient's severe lung problem. The volume respirator essentially breathed for the patient and involved a tube being secured in her mouth. Often, between her admission to the ICU and the date of the incident, W.T. had torn the respirator tube out of her mouth, so she had been continuously restrained and sedated to keep this from happening again. Each time W.T. had extubated herself she had been "blue coded," meaning she had suffered either cardiac arrest or shock. Whether or not W.T. weighed between 225 and 250 pounds or weighed 350- plus pounds cannot be determined with any reasonable degree of accuracy since there is equally credible evidence over the entire foregoing range of poundage. It is material, however, that by all accounts of all witnesses, W.T. was markedly and grossly obese to the extent that her size, shape, and weight contributed to her several health problems and rendered her a patient more difficult to diagnose, more difficult to x-ray, more difficult to move, and more difficult to nurse and medically attend than she would have been otherwise. The evidence as to whether W.T.'s obesity impeded medical personnel from correctly interpreting her breath sounds on August 5, 1987, the date of the incident, is divided, as is the evidence as to whether or not on that date W.T.'s pacemaker was visible to the naked eye, but upon the greater weight of the credible evidence as a whole, it is found that on August 5, 1987, W.T.'s obesity, generally deteriorated condition, and left pneumothorax rendered the presence, volume, and location of breath in each lung subject to interpretation and "judgment call," and that unless one were specifically looking and feeling for a pacemaker, one would not necessarily have been able to detect the pacemaker in W.T.'s left chest due to the extraordinarily heavy pad of fat and the absence of scarring in that location. The foregoing finding of fact has been reached because with the exception of the complaining witness, Nurse Counihan, all factual witnesses either testified that they did not notice a pacemaker scar or they specifically noticed there was no scarring on W.T.'s chest. Also, with regard to breath sounds, both Mr. Starr and Respondent listened for W.T.'s breath sounds on the morning of the incident and within a very few minutes of each other. Mr. Starr described W.T.'s breath sounds when he entered her room as decreased on the right and absent on the left. His findings were consistent with a left pneumothorax but he never informed Respondent what he had found. Respondent arrived only a few minutes later and could not get any breath sounds from either side. Dr. O'Leary, accepted as an expert in pulmonology and the insertion of chest tubes, opined persuasively that one could not rely on breath sounds to locate which side the pneumothorax was on in the face of a recent x-ray. Also, the use of the respirator could have been misleading to either or both Mr. Starr or Respondent. X-rays taken of W.T.'s chest at least ten times between July 23, 1987 and July 31, 1987 clearly depict that the pacemaker was on the left side of W.T.'s chest. These x-rays were reviewed by Respondent with a radiologist the day before the events which are the focus of these charges took place. The radiology reports of W.T.'s chest x-rays dated July 25, 1987, July 28, 1987, and July 31, 1987 specifically mention the pacemaker but only the report dated July 28, 1987 states that the pacemaker overlies the left thorax. Respondent did not review any narrative reports when he and the radiologist were reviewing the actual x-rays together. There is no evidence that this procedure was outside the appropriate standard of care. Dr. Dworkin, expert in radiology and quality assurance and review, Dr. O'Leary, and Dr. Rosin, Petitioner's internal medicine expert, all testified that it is not below the professional standard of care for a treating physician to forget within a day after such an x-ray review which side a pacemaker is on unless the pacemaker enters significantly into his treatment of the patient, which in this case it did not. By the early morning hours of August 5, 1987, W.T. had become even more critically ill with multiple system failures, including a failure in the cardiopulmonary systems, a neurological deficit, and failure of her renal functions. The mortality rate of a patient suffering from ARDS, without considering the other conditions from which W.T. was suffering, exceeds 50%, and responsible medical retrospective estimates made at formal hearing of W.T.'s specific survival chances in the early morning hours of August 5, 1987 fall in the 10-50% range. During the early morning hours of August 5, 1987, the nurses on duty in ICU were having trouble maintaining W.T.'s blood pressure. They began telephoning Dr. Desai and Respondent at approximately 4:00 a.m. One of those doctors, most probably Dr. Desai, ordered a portable chest x-ray of W.T., which was accomplished at 6:30 a.m. by Josephine Christnagel, R.T., who is a registered x-ray technologist. At the time this x-ray was performed, W.T. was already in critical condition and could not speak or respond. W.T.'s condition was such that she probably was not salvageable when Respondent arrived on the scene at 7:00 a.m. on August 5, 1987. Unbeknownst to anyone at this point in time, the 6:30 a.m. x-ray had been inadvertently mislabeled by Ms. Christnagel so that the left side of the patient's chest appeared on the x-ray with a lead marker, "R" (for "right") , on it. This chest x-ray revealed that W.T. had a pneumothorax, and because it was mislabeled, the pneumothorax appeared to be on the right side. If a chest tube is properly inserted from the outside chest wall on the side of the pneumothorax, into the chest cavity, the air can be released and the lung can re-expand, delivering oxygen to the patient and raising blood pressure to normal. At all times material on August 4-5, 1987, the ranking ICU nurse on W.T.'s case was Carey Beninger ne' Counihan, R.N. The ICU nurses notified Dr. Desai by phone of the pneumothorax and he, in turn, notified Respondent. Because Respondent was more nearly ready to go to the hospital, Respondent rushed to the hospital to insert a chest tube into W.T., treatment which he and Dr. Desai, the attending pulmonologist, had agreed was the appropriate treatment for W.T.'s pneumothorax. For the reasons given infra with regard to the time the nurses' notes were compiled and Nurse Counihan's confusion over the x-ray itself, the evidence is not clear and convincing that Respondent was ever told by Dr. Desai or by the nurses by phone that the pneumothorax was on W.T.'s left side (the correct side). Even if Respondent had been so informed by Dr. Desai, since Dr. Desai had never seen the x-ray, it still would have been appropriate for Respondent to rely on the x-ray itself once he got to the hospital, unless at the hospital, something or someone clearly alerted him to the fact that the pneumothorax was actually on the left side. At approximately 7:00 a.m., just prior to the arrival of Respondent, Dr. Michael Danzig, D.O., who was the day-shift emergency room doctor, and Wesley Starr, R.P.T., a respiratory therapist, arrived at ICU and entered W.T.'s room. At approximately the time they arrived, the night-shift emergency room doctor, Dr. Haas, left the room. By all accounts, there was a continuing "commotion," a "ruckus," or "an emergency situation" in progress with at least two nurses, including Nurse Counihan, and other personnel providing various therapies to W.T. who had no palpable blood pressure and was in shock. This atmosphere continued after Respondent arrived shortly thereafter, with the nurses' and Mr. Starr's attention directed to care of the patient. When Respondent arrived, Dr. Danzig became, essentially, an observer. Upon arrival at W.T.'s room, Respondent examined the 6:30 a.m. x-ray against a window with daylight showing through. The x-ray, as it was mismarked, showed a massive tension pneumothorax on W.T.'s right side and a pacemaker on the same side, the right. After review of the x-ray, Respondent examined W.T., including listening for breath sounds. He heard nothing significant from either lung. Dr. O'Leary's opinion that such a finding was not unusual and that Respondent could not rely on either his own examination of breath sounds or that of Mr. Starr (had he even known of Mr. Starr's hearing breath sounds on the right but not the left) at that point is persuasive. Under these circumstances, breath sounds would not have alerted Respondent to a mislabeled x-ray. Respondent relied on the mislabeled x-ray and began to prep the right side of the patient for the chest tube. As Respondent began to prep W.T.'s right side, a dispute arose between himself and Nurse Counihan. Having weighed and evaluated all the testimony and the documentary evidence and exhibits, having reconciled that evidence which can be reconciled, and having eliminated that evidence which is not credible, it is found that the most credible version of this dispute is that Nurse Counihan asked Respondent why he was prepping the right side if W.T. had a left pneumothorax, and Respondent replied, "No, it isn't. Look at the x-ray." To this, Nurse Counihan said, "Yes, it is. I'm sure of it," and pointed to the lung on the x-ray which did not show a pneumothorax (the side next to the nameplate and the side without either a pacemaker or a pneumothorax). Respondent said, "No, it isn't. Look at the damn x-ray!" Respondent then proceeded to intubate on the right side while referring frequently to the mislabeled x-ray. In making the foregoing finding, it is noted that there were significant differences between the testimony of Nurse Counihan and all other witnesses, both factual and expert. Nurse Counihan deposed/testified that both she and another nurse had pointed out to Respondent that the patient's pacemaker was on the patient's left side and so was the pneumothorax. The other three factual witnesses, Starr, Danzig, and Respondent, all testified that they have no recollection whatsoever of anyone mentioning a pacemaker. Even Wesley Starr, called by the Petitioner, and who was present in W.T.'s room at the head of the patient's bed throughout the time of these discussions, testified that, to the best of his recollection, no one mentioned a pacemaker and that he did not recall anyone except Nurse Counihan challenging the Respondent's prepping W.T.'s right side. Also, Dr. Danzig, who was present in the room during the argument, and who testified that he had placed over 200 chest tubes during the course of his medical residency training, testified that if Nurse Counihan had, indeed, mentioned a pacemaker, he would have intervened in order to assist Respondent in determining the correct side of the pneumothorax. Although Petitioner asserted that Dr. Danzig is not credible due to his friendship with Respondent, that argument is not persuasive both due to the remoteness and degree of the friendship and Dr. Danzig's insistence that if Respondent should say that Nurse Counihan pointed to the side of the x-ray showing the pacemaker, then Respondent would be wrong. Respondent apparently did not review W.T.'s records either before or after the dispute with Nurse Counihan. These records were either in her room or elsewhere in the ICU unit, but since, at that point, the nurses' notes had not been compiled from their scratch pads to the patient's chart since before 4:00 a.m., there was nothing in W.T.'s chart/records to alert Respondent that the x- ray was mislabeled or that the patient had a pneumothorax on the left side even if he had reviewed the record. Also, he would have had to go back to the July 31 x-ray or the July 28 radiology narrative before he could have discovered that the pacemaker was on the left. This would have been very time consuming. Also, Dr. Danzig, who actually had made a cursory review of the patient's records when he first arrived in the room, was not alerted by Nurse Counihan's words or her pointing to the x-ray to any reason to search the records for information about the pacemaker. In further assessing Nurse Counihan's testimony, the undersigned has weighed in her favor the consistency of her recent deposition testimony with her notes and the incident report which she completed within five hours after the intubation incident on August 5, 1987. However, weighing against her credibility with regard to her statements then and now that she told Respondent that the pacemaker was on W.T.'s left side is the fact that even her August 5, 1987 report and notes were prepared in the glow of a hindsight favorable to her position and that her deposition shows that she is confused about how a pneumothorax appears on an x-ray. Reconciling all the testimony one can, it is remotely possible that Nurse Counihan said, "It is a left pneumothorax," while pointing to the lung shown on the x-ray as not having a pneumothorax and which, due to the "R" marker on the other lung could be inferred to be the left lung. It is even remotely possible (although not probable or persuasive given the three other factual witnesses' testimony that she had never mentioned a pacemaker) that Nurse Counihan could have told the Respondent, "The pneumothorax is on the same side as the pacemaker," which also was consistent with the x-ray as mislabeled. However, upon the credible evidence as a whole, the only reasonable conclusion is that if Nurse Counihan did mention a pacemaker at the time of her dispute with Respondent, she was ineffective in clearly conveying to Respondent or to anyone else in the room that the pacemaker and the pneumothorax were on the patient's left side or that there was any reason to further search the records or the patient's body to resolve the dispute. It is uncontroverted that, prior to the insertion of the chest tube in W.T.'s right side, absolutely no one, including Nurse Counihan, was aware that the x-ray was reversed, and that Ms. Counihan never informed the Respondent that the x-ray was reversed. Respondent's testimony is accepted that upon placement of the chest tube in W.T.'s right side (the side without the pneumothorax) he heard an immediate audible gush of air. That others in the room did not hear this rush of air is understandable due to the noise and confusion in the room, particularly the respirator sounds. Also, it is uncontroverted that upon placement of the chest tube in W.T.'s right side, the patient's blood pressure, which had been zero, immediately rose into normal range. A dramatic and rapid reestablishment of the patient's blood pressure is the expected result of a proper placement of a chest tube with a tension pneumothorax. All health care personnel present seem to have regarded the blood pressure stabilization as proof that the Respondent had placed the chest tube on the correct side of the patient, because no one, including Nurse Counihan, thereafter protested that a misplacement had occurred. Release of pressure and a return in blood pressure is not normally associated with placement of a chest tube in the wrong side of a patient and there is no definitive medical explanation of why it occurred in this instance, despite Dr. O'Leary's speculation that the gush of air could have been a leak of air across the Mediastrum. After placement of the chest tube in the patient's right side, Respondent ordered an immediate repeat chest x-ray to be certain the tube was placed in the correct lung and was placed correctly. After the patient's blood pressure had been reestablished, Dr. Danzig left the intensive care unit because he believed that the pneumothorax had been relieved completely and because the patient was now stable. If W.T. had not been stable, Dr. Danzig would have remained in the room since he was the day- shift emergency room doctor and he did not know if any physicians other than Respondent and himself were even in the hospital yet. After securing the chest tube and dressing the chest, Respondent left the floor and went to the operating room (OR) to notify the OR staff that there would be a delay before he could begin previously scheduled surgery. Thereafter, on his way to check the new x-ray he had just ordered, Respondent met Ms. Christnagel, who was bringing it to him. Ms. Christnagel then informed Respondent that she had mislabeled the 6:30 a.m. preintubation x-ray. Respondent simultaneously reviewed the new, postintubation x-ray and discovered that he had placed the chest tube in the wrong side of W.T.'s chest. At approximately the same time, W.T.'s blood pressure again dropped and a "code blue" was called. Dr. Gloria Mikula, M.D., who happened to be in the ICU at the time W.T. coded, "ran the code" to attempt to reestablish the patient's blood pressure. Throughout the time in which Dr. Mikula was running the code on this patient, no one, including Nurse Counihan, said anything to the effect that W.T. may have had a chest tube placed in the wrong side. In fact, the nursing staff did not even inform Dr. Mikula that this patient had had a pneumothorax and chest tube insertion prior to the code being called. Such information would have been important from a medical standpoint because it would have allowed Dr. Mikula to act immediately to relieve the tension in the patient's chest. Immediately upon reviewing the repeat chest x-ray and upon hearing the announcement of the code blue at the same time, Respondent rushed back to W.T.'s room, placed a chest tube in the patient's left side, and the patient's blood pressure was again reestablished. However, some time later in her hospitalization, W.T. expired. Nurse Counihan's failure to say anything to Dr. Mikula about the pneumothorax is further indicative of her immediate satisfaction that Respondent's intubation on the right side had been acceptable and that it was only after he discovered his error through the new x-ray and correctly intubated W.T. on the left side that Nurse Counihan completed her notes and incident report describing his error for the chart. The notes were transposed from her scratch pad and memory at approximately noon, August 5, 1987. Dr. Rosin, Petitioner's expert in internal medicine, criticized Respondent's performance as below the professional standard of care because he felt that once Respondent was made aware in the patient's room by Nurse Counihan that the pneumothorax could be on the patient's left side, Respondent had an obligation to make further inquiry or investigation before inserting the chest tube in the patient's right side. In Dr. Rosin's opinion, Respondent's investigation could have taken several routes: review of earlier x-rays and the patient's record, further conversation with the nurse, further hands-on examination of the patient for signs of the pacemaker, and/or ordering a new x- ray. Although Dr. Rosin testified that Respondent should have ordered a repeat x-ray so as to resolve the dispute with Nurse Counihan before inserting the chest tube on W.T.'s right side, he also conceded that the only possible adverse effect of the decision Respondent made was the delay in relieving W.T.'s condition. The chest intubation involved is not a benign or casual procedure, but no actual harm occasioned by misplacement of the chest tube was demonstrated in this case, and the maximum amount of time which would have been saved, under Dr. Rosin's approach, would have been that short period of time it took for the Respondent to place the chest tube and dress the wound. Under the circumstances, if Respondent had delayed intubation, W.T. would probably have "coded blue" before the correctly labelled chest x-ray could have been performed anyway. In light of the confused state of the patient's breath sounds, obesity, and lack of scarring, the fact that no nurses' notes had been codified since before 4:00 a.m., Nurse Counihan's own confusion about the mismarked x-ray, and how far back in the patient's chart Respondent would have had to look before he would have been able to locate anything useful about the pacemaker, it is found that Respondent behaved reasonably in an emergency situation, and Dr. O'Leary's and Dr. Dworkin's expert opinions that he did not violate the professional standard of care in the first insertion of the chest tube are accepted. It is also found that the Respondent's procedure in ordering the new chest x-ray and leaving the room after the first intubation without further search of the records or further conversation in the room was reasonable and appropriate under the circumstances.
Recommendation Upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Osteopathic Physicians enter a Final Order dismissing all charges against Respondent. DONE and ENTERED this 25th day of July, 1991, at Tallahassee, Florida. ELLA JANE P. DAVIS 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 25th day of July, 1991.
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
