The Issue Should discipline be imposed against Respondent's license to practice medicine for violation of Section 458.331(1)(t), Florida Statutes (2003)?
Findings Of Fact Stipulated Facts Petitioner is the state department charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 458, Florida Statutes. Respondent was (is) a licensed physician within the state of Florida, having been issued License No. 84357. At all times material to this complaint Respondent's address of record was 68 East Ludlow Place, Citrus Springs, Florida 34434. On or about May 18, 2004, Patient R.D., a 73-year-old male, presented to Citrus Memorial Hospital, Family Care Center in Lecanto, Florida. Patient R.D.'s chief complaint on May 18, 2004, was of constipation and last major bowel movement on May 16, 2004. On or about May 18, 2004, Patient R.D. was physically examined, and the examination revealed normal vital signs, moderately distended abdomen with slowed, but present bowel sounds in all four quadrants, no masses, and a nontender abdomen. On or about May 18, 2004, Respondent ordered an abdominal flat plate and upright X-ray, which showed "obstruction with stool, air fluid levels." On or about May 18, 2004, Patient R.D.'s diagnosis was constipation with partial bowel obstruction. On or about May 18, 2004, the X-rays were interpreted by a radiologist with an impression of marked dilatation of small bowel, likely due to small bowel obstruction. On or about May 18, 2004, Patient R.D. was instructed for treatment of his diagnosis to take Miralax powder as needed and milk of magnesia in between, keep fluid intake up and go to ER (emergency room) if pain increased in the abdomen or fever or vomiting develop. Respondent prescribed Miralax to Patient R.D. Section 458.331(1)(t), Florida Statutes (2003), sets forth grounds for disciplinary action by the Board of Medicine for gross or repeated malpractice or the failure 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. Respondent's Care of Patient R.D. Respondent received his Doctor of Medicine Degree from George Washington University. He became board certified in family practice in 1980 and was recertified in 1987, 1994, and 2001. Respondent practices at the Allen Ridge Family Care Center, an urgent care facility that is part of Citrus Memorial Hospital. On May 18, 2004, a history was taken from Patient R.D. The patient complained of constant mild abdominal pain. The patient reported that he had not had a stool for two days, that his last bowel movement (bm) had occurred two days earlier. The patient was complaining that he was constipated and that his stomach felt full. When Respondent saw Patient R.D., it was their first encounter. Respondent examined the patient. When Respondent asked the patient if he had blood or black stool, Patient R.D. denied either condition. Having a complaint of GI problems, Respondent was trying to ascertain whether the patient had internal bleeding when inquiring about the condition of the stool. Respondent, when recording information on Patient R.D.'s chart, noted that the distention and constipation were mild and constant. Respondent inquired of the patient concerning diarrhea, chills, vomiting, and issues with his appetite and noted that the patient was not suffering from any of those symptoms, other than to note that the patient's appetite was slightly down. The fluid intake was noted as being adequate for purposes of hydration. A nurse practitioner had noted the nature of the medications the patient was taking. Respondent did discuss those medications with the patient. Respondent was aware of the patient's vital signs and found them to be normal, as taken by a nurse. Respondent noted that the patient was in "no apparent distress," that is, he did not look sick by appearance. Instead the patient appeared well. Respondent noted in the chart that the bowel sounds were slowed but present in all four quadrants. Respondent wanted to determine whether the patient had absent bowel sounds or very rapid sounds that would have alerted Respondent to difficulties experienced by the patient. Absent bowel sounds represent some inflammatory process in the abdominal cavity such as appendicitis or a kidney stone, whereas rapid bowel signs signify a possible obstruction. Respondent noted "negative bruits," referring to the use of the stethoscope on the abdomen to listen for arterial sounds. Respondent found the liver and spleen to be normal upon examination. There was no hernia. There was "no CVA pain," referring to pain in the back that would be accompanied by flank pain. When Respondent palpitated the patient's abdomen light and deep, the patient reported that he experienced no pain. He responded by saying that he "feels full," which Respondent understood was in association with moderate distension. Before the visit, Respondent had experience with the type of patient represented by Patient R.D. Respondent has treated patients over time who have small bowel obstructions and who have constipation. Respondent's working differential diagnosis was that the patient was probably constipated, as had been reported. Respondent decided to have an X-ray made of the patient's abdomen. The decision to order an X-ray was in view of the distension. Respondent reviewed the results of the X-rays. The X-ray series were both flat and upright. The flat X-ray refers to lying flat (supine). That approach was requested in that Respondent was trying to determine how much stool and air were in the abdomen. Respondent was using the results of the X-ray to try to determine if the patient had a potential for obstruction. Respondent's impression of the results of the X-ray was that the rectum area showed stool in it. There was some indication of stool in the colon. Respondent was unsure as to whether there was stool in the small bowel. There were air fluid bubbles in an area that probably reflected the small bowel. Ultimately Respondent reached a diagnosis of constipation with partial bowel obstruction. Respondent, when he looked at the X-rays, went back to discuss the findings with the patient and said: Your x-ray does not look good. It has air fluid levels. You could have a problem here. It does not match up with your exam and your vital signs. You got a bad x-ray. The response by the patient was something to the effect that he did not care if he had a bad X-ray. He was constipated and he wanted something for his constipation. Respondent elected to give the Petitioner Miralax powder and give him precautions if anything developed such as abdominal pain, fever, or vomiting that was not in evidence at the moment, that the patient should go to the emergency room. Based upon the X-ray results, Respondent noted in his testimony that the patient: . . . wasn't out of the woods as far as I was concerned yet. Our standard procedure on a patient like this, is you get these air . . . you get something like that back . . . . probably, went in and recommended that he go to the emergency room. Respondent goes on to say in his testimony: . . . now if everything looked o.k. on this, this guy would have his Miralax prescription, be out of the door, and I wouldn't even see him if he had a normal x- ray. I went in the room and I talked to the guy and I said, look you got this and it could be obstruction, and he goes, 'what's obstruction' I said, well, just what we've been talking about this morning, blah, blah, blah. Pain, increase, bowel sounds, vomiting, 'Do I have any of that?' Respondent then describes the verbal exchange between the patient and Respondent as to the severity of the situation, and Respondent says in his testimony ". . . he won." Respondent indicated that the patient convinced Respondent that he was not ill. In summary, the Respondent told the patient that he could be in trouble or he might be fine. Respondent was also aware of other cases as he describes: . . . a certain percentage of people admitted for partial bowel obstruction like this that go through the hospital and has got to be a significant that go home the next day. They poop and go home the next day, 30 or 40 percent, o.k. So this guy could be that guy easily because he had symptoms so -- and he is not going to the ER because he waited two hours, three hours, whatever it was. I've seen nursing home patient's x-rays twice as bad as that and they are constipated and they are not in pain, so I had experience with these patients that some of them are not in trouble. I told this guy, you could be in trouble and this is -- and he said, 'I just need something for my constipation'. Respondent recognizes that the patient was coming to him for medical care and that he was obligated to determine if the patient was ill and that he could not rely completely upon someone else's ability to convince him of the circumstances. Respondent did not find the patient to look ill and indicated through his testimony that the patient ". . . was not in any trouble." Respondent did not find the patient in acute distress at the time the patient was seen. Respondent believes that had the patient been suffering small bowel obstruction when he was seen, that instead of moderate distension there would have been severe distension, and instead of the bowel sounds slow and present, they would have either been absent or increased. There would have been tenderness in the abdomen. There may have been a mass where none was found on examination. There was no finding of colicky pain, which Respondent considers to be the gold standard of bowel obstruction, crampy abdominal pain in severe waves that "double you over." Respondent called the patient's condition constipation with partial obstruction because of the findings in the X-ray. Respondent recognizes that there was some obstruction. He attributed the bowel obstruction to constipation caused by feces. However, in making his choices for care Respondent recognizes that distension is a symptom of obstruction. The inability to defecate is a symptom of obstruction. Respondent did not rely upon the radiologist's reading and report concerning the X-rays when making his choices for Patient R.D.'s care because he did not have the report at that time. Respondent recognized the Physician's Desk Reference (PDR) available on May 18, 2004, as a reference source and in its discussion of Miralax was an authoritative source and that according to the PDR, it considered Miralax as contraindicated for patients who are known or suspected of having small bowel obstructions. Expert Opinion Dr. James Schaus is licensed to practice medicine in Florida and board certified in family practice. He was offered as an expert to express an opinion concerning Respondent's care provided Patient R.D. on May 18, 2004. To prepare him for that assignment he reviewed investigative materials from the Department, Respondent's records and other available records that pertain to Patient R.D.'s care. When asked to express an opinion concerning whether Respondent met the applicable standards of care as defined by Florida Statutes in the examination, diagnosis and treatment of Patient R.D., Dr. Schaus expressed the opinion that Respondent: . . . deviated from the standard of care in this case by failing to refer the patient to a hospital for immediate further evaluation of the small bowel as indicated on the abdominal x-ray and the physical examination finding of a distension. The abdominal x- ray revealed multiple air and fluid filled loops in the small bowel which are marketedly dilated and associated small bowel air fluid on upright films. A small amount of air, stool, within colon, impression marked dilation of small bowel likely due to small bowel obstruction. Dr. Schaus' view of the definition of "standard of care," is the "failure to practice medicine at a level of care, skill, and treatment which are [sic] recognized by a reasonably prudent similar acting physician as being acceptable under similar conditions and circumstances." Dr. Schaus went on to state the opinion: I believe that these x-ray findings taken together with the fact that the patient was distended on the physical exam and complained of some pain with the distension of abdominal wall obligated Dr. Hopkins for immediate further hospital evaluation of this patient. I also believe that Dr. Hopkins deviated from the standard of care by prescribing Miralax to the patient who had the diagnosis of partial small obstruction. In addition to expressing the opinion that Respondent should have arranged for immediate hospitalization of the patient diagnosed with partial small bowel obstruction, and the problem with Miralax, Dr. Schaus expressed the opinion that there was a deviation from the standard of care for the failure to do a digital rectal exam on the patient. Dr. Schaus expressed an opinion that Respondent should have used a digital rectal exam with this patient to determine the presence of stool, occult blood, and the condition of the prostate and to check for rectal or perianal masses. This was the standard of care that should have been pursued in this case because the patient complained of constipation and possible bowel obstruction. If an impaction of stool were found, this would aid in the diagnosis. It would be properly considered the cause and would constitute the diagnosis. If the digital rectal exam revealed gross blood that is important, or occult blood on the stool sample as detected through a chemical test, those findings would be helpful as well. Gross blood refers to visible blood. It is bright red or darker colored. If a mass is found, it might be an indication of colon cancer. As Dr. Schaus explained, the presence of blood indicates a more serious problem in that the typical constipation does not bleed. Dr. Schaus perceived the case involving Patient R.D. as one in which constipation was the patient's presenting complaint, setting up the possibility that it was in view of constipation as such or could be from bowel obstruction. Dr. Schaus expects the physician to determine that spectrum from the very benign to the very serious. In his review of the record, Dr. Schaus notes that the patient had an obstruction as evidenced by Respondent's diagnosis of obstruction. In particular he emphasizes the diagnosis of "constipation with partial bowel obstruction." In his testimony, Dr. Schaus had referred to small bowel obstruction in his impression of the findings by Respondent but later acknowledged in his testimony that Respondent had described a condition which was "partial bowel obstruction." The obstruction would be found within the intestinal tract. The nature of the blockage in Dr. Schaus' opinion can be a partial blockage that would limit the passage of stool or a complete blockage that can cause more serious problems. In this case, Dr. Schaus believed that it was clearly indicated that the patient had a significant bowel obstruction and that it was a small bowel obstruction and the patient needed to be admitted to the hospital for further evaluation and treatment. Dr. Schaus considers the terms "small bowel" to be synonymous with "small intestine." Dr. Schaus, in expressing his opinion, relies upon Respondent's interpretation of the X-ray where the Respondent notes "abdominal flat and upright obstruction with stool, air fluid levels." Dr. Schaus expressed the opinion that Respondent should have proceeded logically with the next step after discovering the small bowel obstruction, which was to make sure that the patient receives immediate evaluation and treatment in a hospital setting. The treatment that was given was on an out- patient basis with instruction for the patient to use Miralax as needed, with milk of magnesia PRN and to keep his fluid intake up and to report to the emergency room if he had problems with abdominal pain, fever, or vomiting. That approach was not acceptable in Dr. Schaus' opinion given the signs, symptoms, and radiographic findings in relation to Patient R.D. By choosing to have an abdominal X-ray performed on Patient R.D., this was an indication to Dr. Schaus that Respondent believed the patient was experiencing something other than typical constipation. A patient who has only constipation would not be subject to an abdominal X-ray. Concerning the prescription of Miralax, Dr. Schaus noted that this medication is an osmotic agent. It is considered a fairly powerful laxative. It is designed to cause the stool to retain water leading to a softer bowel movement, but it can be a dangerous treatment or contraindicated in a patient with known or suspected bowel obstruction as mentioned in the PDR. Dr. Schaus considers the PDR to be authoritative, and it is a commonly-used reference source for prescribing medications. When explaining the circumstances concerning Miralax, Dr. Schaus commented that the absorption of water is potentially dangerous in the instance where you have a blockage and you are promoting an expansion in the stool. This patient had partial bowel obstruction and Respondent prescribed the medication. Dr. Schaus believed that the patient could have had the entire spectrum from simple constipation to a complete bowel obstruction, because a patient may present with a wide variety of symptoms. In this case, the typical expectation of nausea and vomiting does not overcome the necessity for having a high- end suspicion of serious problems in the interest of not overlooking something. Dr. David A. Weiland, Jr., is licensed to practice medicine in Florida. He is board certified in internal medicine. His practice principally involves care of adult patients. In the past, he has taught family medicine for a period of almost ten years. Patient R.D. was an elderly patient, a type of patient seen in family practice. Dr. Weiland occasionally uses the PDR when he is unaware of a drug, or, if a drug is new, he will look it up in the PDR in discussing dosage or potential drug interactions. He sees the PDR as one reference source. It serves as a guide in prescribing. Dr. Weiland sees the definition of standard of care as being "that practiced by a prudent clinician in similar circumstances, with similar findings." In preparing himself to offer testimony, Dr. Weiland reviewed the Respondent's medical records in association with Patient R.D. He considered those records to be sufficient for him to render an opinion about the care provided Patient R.D. by Respondent. Dr. Weiland in his practice deals with 73-year-old males, such as Patient R.D. He deals with males who have constipation. Dr. Weiland has dealt with patients with distention of the abdomen. At present, Dr. Weiland's predominant practice is in hospice care. Many of his patients are severely constipated because of the use of narcotics due to the nature of their illness in the hospice setting. In deciding the choice of treatment, the choice of medications for addressing a 73-year- old with distention and constipation for two days, in his practice, Dr. Weiland relies on trials and failures or successes with the use of previous medications and an understanding of the illness and the degree of illness. He looks for symptoms such as diarrhea, pain associated with a fecal mass of the rectal wall, nausea, and vomiting, to guide him in deciding where the obstruction may be located and how to address the suspected obstruction. According to Dr. Weiland, you need to encourage the forward motion of the bowels in elderly patients. Dr. Weiland uses Miralax in his practice. He describes it as a promotility agent, an agent that allows the bowel to move more functionally. Miralax is not a drug that Dr. Weiland routinely prescribes. He just does not use the drug often, even though he understands it to be a very popular laxative. Dr. Weiland believes that Miralax is contraindicated for people with mechanical bowel obstruction, meaning anything mechanical that causes the bowel to be obstructed which could be cancer, adhesions, or twisting. The complete bowel obstruction, regardless of the reason, would be contraindicated for use of Miralax. With a partial obstruction, it is not clear to him whether Miralax is contraindicated. If there is stool movement forward, there is no absolute contraindication. The fact that the patient was not vomiting was an indication to Dr. Weiland that the stool was moving forward. With a complete bowel obstruction, the patient would present nausea and vomiting. Dr. Weiland agrees with the PDR warning that Miralax is contraindicated for patients who have known or suspected bowel obstructions. Symptoms suggestive of a bowel obstruction present would be nausea, vomiting, and abnormal distention and should be evaluated to rule out the bowel obstruction before using Miralax therapy, as explained in the PDR. Dr. Weiland thinks the key elements in the evaluation of those symptoms relate to nausea and vomiting and a patient with extreme nausea and vomiting should not be given promotility medication. Therefore, Dr. Weiland's opinion concerning the use of Miralax is conditioned upon those symptoms in relation to nausea and vomiting. Concerning general contraindications for using medications, Dr. Weiland is familiar with a medication by its general use, having looked it up on the PDR, and he has used other texts for medications, pharmacopeia. Dr. Weiland's response to contraindications depends on whether they are considered as absolute contraindications or relative contraindications. He sees the process of determining the use of the medication as dependent of the patient's underlying situation and the whole clinical condition. Dr. Weiland is also familiar with milk of magnesia, which is a chemical laxative. In addressing a patient's condition, Dr. Weiland treats the symptoms about 95 percent of the time. He uses additional testing when he confronts something unusual. For example, severe nausea would lead him to consider the use of X-rays. Other examples of a patient's circumstances in his experience that might cause the use of an X-ray or CT scan would be severe pain that was in association with a history of a particular malignancy known to cause complete obstruction, ovarian cancer or prostate cancer. Dr. Weiland would be impressed with passing significant amounts of blood in the stool, bloody diarrhea, high fever, nausea, and vomiting. But most constipation he treats initially, medically, and it would be necessary that he would have other of the issues that he described going on before it would warrant further investigation. Dr. Weiland explains that most treatments of small bowel obstruction are conservative initially. If the patient presents with a complete bowel obstruction as evidenced by nausea, vomiting, that patient is admitted to the hospital and the management involves bed rest and the provision of IV fluids to see if the patient resolves the situation. To determine whether there is a small bowel obstruction, two factors enter in, according to Dr. Weiland. One is the clinical presentation, which is abdominal pain, marked distension, nausea, and vomiting. If one of those factors is not present, Dr. Weiland does not believe that it would necessarily be considered as being a small bowel obstruction. He thinks that there is the possibility of confusing obstruction, in the sense of whether it is partial or complete. Dr. Weiland understands the differences between patients and the way they present abdominal pain and distension could be explained by lots of things, among them bowel obstruction. Concerning the Patient R.D. in his clinical presentation, considering the patient's appearance, vital signs, lack of nausea and vomiting no symptoms, Dr. Weiland would not have thought he was dealing with a bowel obstruction. The slow bowel that is described would not lead Dr. Weiland to conclude otherwise. The Respondent's impression concerning the bowel obstruction was based on X-ray findings, as Dr. Weiland perceives the matter. Dr. Weiland would not have gotten those X-rays. He believes that X-rays can sway you in the wrong direction and they do not always represent bowel obstruction. If the patient had presented looking "relatively toxin," Dr. Weiland would have ordered films, and, when he got those films, it would have confirmed the condition. Dr. Weiland proceeded with his opinion based upon the belief that Respondent reached the diagnosis of constipation with partial bowel obstruction after the X-ray results were known. Dr. Weiland looked at Patient R.D.'s X-rays. He found them to be abnormal in that there is evidence of dilation in the case because of striations, and there are fluid levels. In his experience, not all fluid levels are obstructions. Sometimes they are caused by other abnormalities. Dr. Weiland expressed the opinion that the standard of care for a patient like R.D. is that you look at the patient, determine the patient's symptoms, and make a clinical recommendation with a follow-up, and, if the patient systems worsen, then the patient should go to the emergency room for care. Dr. Weiland believes that partial small bowel obstruction could be a life threatening condition. If the patient were facing a life threatening condition, Dr. Weiland would hospitalize the patient. Evidence of a life-threatening condition would be nausea, vomiting, inability to keep down oral medications, and abnormal signs none of which were evidenced in this case in the case of R.D. Dr. Weiland considers abdominal distension to be a non-specific symptom in the patient, as well, abdominal distension with pain is non-specific. Dr. Weiland would not have sent the patient to the emergency room on May 18, 2004. The conservative approach was acceptable. The causation of the problem would often times resolve on its own. Dr. Weiland refers to the Respondent having the luxury of looking at the actual patient and the patient's appearance and the vitals did not appear to be toxic. Dr. Weiland agrees with the Respondent that if the patient developed fever or vomiting he should go to the emergency room. That would be evidence that the patient was experiencing a complete bowel obstruction. Dr. Weiland's reading of the Respondent's reference to partial bowel obstruction is that it is based upon information that Respondent had, including the patient had fecal material, and that the patient is obstipated. Dr. Weiland believes that the partial bowel obstruction could be caused by any number of things, that have been mentioned in his testimony and reflected in this discussion and that the patient should be treated conservatively. If the problem resolves then that ends it. If it does not, then a CAT scan should be considered, and only upon the condition becoming a bowel obstruction that is complete will surgery be necessary. Dr. Weiland agrees that the use of a rectal exam can aid in the determination of the cause of an obstruction. Dr. Weiland expresses a preference to have a rectal exam documented in the patient chart. Having considered the opinions of the medical experts in view of the choices Respondent made in caring for Patient R.D., Dr. Schaus' opinions that Respondent fell below the standard of care in prescribing Miralax with a diagnosis of partial obstruction and the opinion by Dr. Schaus that the Respondent's failure to refer the Patient R.D. to the hospital for further evaluation of bowel obstruction fell below the standard of care are accepted. Although the choice to proceed to the hospital or not would have been the patient's decision, Respondent in his approach did not create that option. Rather he deferred to perceived limitations placed on the care by the patient, commenting that he was there principally for difficulties with constipation. That response to the patient's needs was below the standard of care. Respondent left available the choice to proceed to the emergency room if the patient began to have abdominal pain, fever or vomiting. Dr. Schaus' opinion that Respondent fell below the standard of care in not performing a digital rectal examination on Patient R.D. is accepted when addressing the possibility of a bowel obstruction. Mitigation/Aggravation The record does not reveal any adverse outcome attributed to Respondent's care provided Patient R.D. on May 18, 2004. There is no indication that Respondent has ever been disciplined in Florida or other jurisdictions while practicing medicine.
Recommendation Based upon the findings of fact and conclusions of law, it is RECOMMENDED: That a final order be entered finding Respondent in violation of Section 458.331(1)(t), Florida Statutes (2003), placing Respondent on a period of probation for one year, issuing a letter of reprimand and imposing an administrative fine of $5,000.00. DONE AND ENTERED this 1st day of May, 2007, in Tallahassee, Leon County, Florida. S CHARLES C. ADAMS 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 1st day of May, 2007. COPIES FURNISHED: Ephraim D. Livingston, Esquire Dory Penton, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Christopher J. Schulte, Esquire Burton, Schulte, Weekley, Hoeler & Beytin, P.A. 100 South Ashley Drive, Suite 600 Post Office Box 1772 Tampa, Florida 33602-1772 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
The Issue Did Respondent's failure to intervene in the post-operative period immediately after learning the CT scan results of Patient C.O. near midnight on April 12, 1997, constitute treatment that fell below the standard of care and that he 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, in violation of Section 458.331(1)(t), Florida Statutes?
Findings Of Fact Petitioner is the state agency charged with regulating the practice of medicine in Florida. Respondent is a licensed physician in the State of Florida at all times material to the times alleged in the Complaint, having been issued license number ME 0070668. Respondent, as of May 2001, is board-certified in the area of neurological surgery. On April 3, 1997, Patient C.O., a 50-year-old male, presented to an Otolaryngologist (ear, nose and throat surgeon) with complaints of right side nasal polyps. On April 7, 1997, Patient C.O.'s surgeon ordered a radiological consult and a Coronal CT (up, down, front and back) scan of the right maxillary sinus. The CT scan revealed "complete opacification (blockage) of the left frontal, right ethmoid, right maxillary sinus, as well as the right nasal cavity with complete opacification of right sphenoid sinus." On April 9, 1997, Patient C.O. underwent a surgical procedure to remove nasal polyps. The surgeon removed an extremely large right nasal polyp, measuring approximately 10 cm in length. After removing the large mass, the surgeon noted smaller polyps and removed these also. After removing the polyps, the surgeon noted a "large pulsatile mass," which he biopsied. Biopsy results indicated that the "mass" was brain tissue. During the course of this procedure, the patient's cribriform plate had been pierced. This plate forms a barrier between the nasal cavity and the base of the brain. As a result of this puncture, the surgeon had removed a portion of Patient C.O.'s brain. The surgeon requested an intraoperative consult with Respondent. The surgeon and Respondent talked by telephone and Respondent recommended sealing off the brain tissue with a surgical flap and packing. An arteriogram was performed on Patient C.O. to determine if bleeding was from an artery or vein. It was determined that the bleeding was from a vein. He also, recommended placing Patient C.O. in the neurological intensive care unit, which was done, and the patient was stabilized. A CT scan, ordered by the surgeon, noted a right frontal hemorrhage and pneumoncephalus (air at the top of the skull). On April 10, 1997, drainage was noted from the right nostril of Patient C.O. Respondent noted that drainage was suspicious for cerebrospinal fluid (CSF). Respondent then considered various options in order to stop the leakage of CSF. On April 10, 1997, Respondent performed a surgical procedure which placed a spinal drain in Patient C.O. to control the intracranial pressure and to permit an outlet for the CSF. Respondent was attempting to allow the rupture to the cribriform plate to heal on its own. On April 11, 1997, a CT scan revealed large areas of air in the frontal areas of the skull. On April 12, 1997, it was determined that the rupture of the cribriform plate had not healed on its own. Patient C.O. had persistent drainage from the right nostril. He was taken to the operating room for a direct intracranial surgical repair of the defect. A CT scan demonstrated an increase in the frontal hemorrhage, a large left subdural hematoma, and brain swelling. On the afternoon of April 12, 1997, Respondent performed a bi- frontal craniotomy on Patient C.O. to close off the leaking of spinal fluid from the brain in the area behind the patient's forehead (CSF leak). The surgery began at 12:15 p.m. and anesthesia was initiated at approximately 12:30 p.m. on April 12, 1997, and surgery concluded at about 5:00 p.m. The procedure involved making an incision across the top of the scalp, from ear to ear, gaining access to the brain by making incisions in the cranium, then lifting the brain to allow access to the cribriform plate. This was accomplished without incident. During the post-operative period, the anticipated reaction of the patient was to return to post-operative status, or to improve neurologically beginning within two hours after the surgery ended. During the course of post-operative care, Patient C.O.'s vital signs and neurological statistics were constantly monitored. Patient C.O. did not show any improvements several hours after surgery as would be expected, but began to show signs of neurological deterioration. Because Patient C.O. did not improve neurologically after the surgery, Respondent, at about 9:30 p.m. on April 12, 1997, ordered a CT scan to be done immediately. Patient C.O. was taken for his CT scan around 10:45 p.m. The CT scan report by radiologist at Florida Hospital was called in to the hospital unit at 11:50 p.m. on April 12, 1997. Respondent was at home in bed, sleeping, when he was paged. Respondent called in and was told by telephone of the "wet read" results of the CT scan by the neuroradiologist. After obtaining the CT scan report, Respondent disagreed with the neuroradiologist's recommendations, ordered the continuation of the interventions which he had previously ordered, and issued no new medical orders. The April 12, 1997, CT scan results were reduced to writing and showed the following findings, when compared to the CT scan taken of Patient C.O., on April 11, 1997: Noncontrast examination shows numerous abnormal findings. Compared to the 04/11/97 study acute left subdural hemorrhage is similar. There is a large intraparenchymal frontal hemorrhage that has a similar appearance . . . . DIFFUSE INTRACEREBRAL SWELLING PROBABLY WORSE IN THE POSTERIOR FOSSA. OBLITERATED FOURTH VENTRICLE. VENTRICLE SIZE SIMILAR. INCREASED BLOOD FRONTAL REGION. UNCHANGED SUBDURAL LEFT POSTERIOR PAREITAL REGION. VENTRICULAR SIZE STABLE. PNEUMOCEPHALUS UNCHANGED. INTRAVENTRICULAR BLOOD STABLE. At 5:15 a.m. on April 13, 1997, Patient C.O.'s neurological status took a significant turn for the worse. The patient was interbated, and all appropriate measures were taken to attempt to revive the patient. Patient C.O. lapsed into coma and was unable to breathe sufficiently for himself; he sustained respiratory failure and coma. In the early morning hours of April 13, 1997, Patient C.O's neurological status was discussed with his family, and the decision was made to execute a do-not- resuscitate order. The patient never recovered and died two days later on April 15, 1997. Petitioner alleges that the standard of care required Respondent to take some affirmative or new action to intervene post-operatively on the night of April 12 through 13, 1997, to determine the cause of the deterioration and prevent irreversible brain damage. In support of Petitioner's position with regard to Respondent's standard of care, it presented the testimony of Dean C. Lohse, M.D. Dr. Lohse is a board-certified neurosurgeon who is licensed to practice medicine in the State of Florida. Dr. Lohse is a similar health care provider to Respondent, and he qualifies as an expert witness under Florida law. Dr. Lohse testified that he had several criticisms of the manner in which Respondent managed Patient C.O.'s post-operative care. Dr. Lohse was critical of the manner in which Respondent reacted to the information which was provided to him regarding the CT scan which was taken on the night of April 12, 1997, and which was communicated to Respondent at approximately midnight on that same night. In response to this information, Dr. Lohse was of the opinion that Respondent should have initiated some new intervention, including returning Patient C.O. to surgery, initiating medications to reduce swelling, introducing a pressure monitor, or changing the position of the lumbar drain. However, during the course of cross-examination, Dr. Lohse conceded that he could not say whether a return to surgery would have resulted in a different outcome for Patient C.O. Likewise, he could not state to within a reasonable degree of medical probability whether the introduction of medications to reduce the swelling would have worked. He could not state within a reasonable degree of medical probability whether the placement of a pressure monitor would have created a different result. Finally, he conceded that the issue of changing the lumbar drain was best left to the clinical judgment of the physician who is presiding over the care of the patient. Respondent testified on his own behalf at the final hearing. Respondent explained the April 12, 1997, craniotomy which he performed. He also explained the course of treatment which was followed with Patient C.O. in the hours subsequent to the conclusion of the craniotomy. Respondent explained his rationale behind ordering a stat CT scan, and he described the basis for his response to the information received at that time. Respondent testified that although he considered a return to surgery based upon the information contained within the CT scan, he decided against this option, as performing another surgery would only have been for the purpose of removing additional portions of Patient C.O.'s brain, including areas of the brain which are designed to control significant elements of an individual's personality. Respondent made the determination at that time that performing another surgical procedure would likely have caused more harm than good. Respondent testified that brain swelling reducing medication had been introduced previously and that the introduction of more or different brain swelling-reducing medications would not have addressed Patient C.O.'s condition. Respondent testified that the placement of a pressure monitor would have been pointless, given the information which he was able to obtain during the course of the craniotomy procedure. A pressure monitor is designed to measure increased levels of pressure on the brain. Patient C.O. was suffering from the opposite problem. Patient C.O.'s brain was actually flaccid, suffering from an absence, rather than an overabundance, of pressure. Therefore, the placement of a pressure monitor was never considered, as it would not have been of any use under the circumstances. Respondent testified that there was no need to change the aspect of the lumbar spinal drain. The lumbar spinal drain in this particular case was adequately controlled, at 5 ccs per hour. Thus, the use of the spinal drain was appropriate under the circumstances. Respondent's testimony is credible. Respondent also presented expert testimony, via deposition, of R. Patrick Jacob, M.D. Dr. Jacob is a board- certified neurosurgeon who currently works at the University of Florida in Gainesville. Dr. Jacob testified as to his education, training, and experience. He is a similar health care provider to Respondent, qualifies as an expert under Florida law, and can render expert medical opinions regarding the applicable standard of care in this case. Dr. Jacob testified that in his opinion, to within a reasonable degree of medical probability, Respondent met the applicable standard of care. He addressed each of the specific criticisms raised by Dr. Lohse. He specifically rejected the idea that another surgical procedure should have been performed, stating that to do so would have done more harm than good. He rejected Dr. Lohse's contention that the introduction of additional medications to reduce swelling would have been appropriate. Dr. Jacob disagreed with Dr. Lohse's suggestion that the placement of a pressure monitor would have been appropriate under the circumstances of this case. Finally, Dr. Jacob took issue with Dr. Lohse's opinion that a change in the lumbar spinal drain was warranted given Patient C.O.'s condition. On cross-examination, Dr. Jacob testified that he felt that Respondent's response to the information contained within the April 12, 1997, CT scan was appropriate. He was then presented with hypothetical questioning regarding whether doing nothing in response to the information contained within the CT scan would have been appropriate. Dr. Jacob testified that doing nothing in response to the information contained within the CT scan report may have constituted a deviation from the accepted standard of care. However, according to Dr. Jacob's review of the records, and Respondent's testimony at the final hearing, it is apparent that a decision was made by Respondent to continue with the interventions which had already been initiated, which under the circumstances of this case constitutes an affirmative act by Respondent to address the treatment and care of Patient C.O. Dr. Jacob's testimony is both credible and persuasive. The evidence is not clear and convincing that Respondent failed to intervene in the post-operative period immediately after learning the CT scan results of Patient C.O. around midnight on April 12, 1997. Respondent did not fail to take appropriate action after learning the results of the CT scan at midnight on April 12, 1997. Respondent ruled out several options and elected to continue with the interventions already initiated. Therefore, Respondent did not fall below the standard of care for similarly situated neurosurgeons and his actions on April 12 through 13, 1997, did not constitute a failure to practice medicine with that level of skill, care, and treatment recognized by a reasonably prudent similar neurosurgeon as being acceptable under similar conditions and circumstances.
Recommendation Based on the foregoing, it is RECOMMENDED that the Board of Medicine issue a final order finding that Respondent has not violated Section 458.331(1)(t), Florida Statutes, and dismissing the Administrative Complaint. DONE AND ENTERED this 19th day of July, 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 19th day of July, 2002. COPIES FURNISHED: Michael R. D'Lugo, Esquire Wicker, Smith, O'Hara, McCoy, Graham & Ford, P.A. Post Office Box 2753 Orlando, Florida 32802-2753 Shirley J. Whitsitt, Esquire Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 39-A Tallahassee, Florida 32308 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
The Issue The issue to determine in this matter is whether Ashton Payne suffered a "birth-related neurological injury" as defined by section 766.302(2), Florida Statutes, for which compensation should be awarded under the Florida Birth-Related Neurological Injury Compensation Plan.
Findings Of Fact Ashton was born on January 19, 2018. Ashton was delivered at Winter Park Hospital. Petitioner Michele Mark is Ashton's mother. Petitioners are Ashton's natural parents and legal guardians. Michele M. Cabrera, M.D., delivered Ashton at Winter Park Hospital. Dr. Cabrera was a "participating physician" in the Plan at the time she rendered obstetrical services on January 19, 2018. See § 766.302, Fla. Stat. Dr. Cabrera provided her obstetrical services in the course of Ashton's delivery, and the resuscitation in the immediate post-delivery period. Ashton weighed 3310 grams at birth. The parties do not dispute that Ashton has suffered an injury to his brain due to oxygen deprivation which has left him permanently and substantially mentally and physically impaired. The parties do not dispute that the NICA notice requirements, as set forth in section 766.316, were met. Ashton was born under very challenging circumstances. At approximately 1:11 a.m. on January 19, 2018, Ms. Mark appeared at Winnie Palmer.3/ Ms. Mark, who was at 37 weeks' gestation, complained of contractions and severe pain. At Winnie Palmer, a triage nurse evaluated Ms. Mark. The examination revealed that Ms. Mark was experiencing intermittent contractions. The nurse also recorded that Ms. Mark's cervix was one centimeter dilated and 100 percent effaced. Ms. Mark informed the nursing staff that an ultrasound two days earlier revealed that the fetus was breech. However, apparently because the birth was not imminent, Ms. Mark was discharged from Winnie Palmer at 2:33 a.m. Back at her home, at approximately 3:19 a.m., Ms. Mark experienced a spontaneous rupture of her fetal membranes (her "water broke"). The rupture immediate resulted in an umbilical cord prolapse. A cord prolapse means that the umbilical cord dropped down through the cervix before the baby. This complication can cause the umbilical cord to be occluded, or squeezed, which can severely diminish the flow of oxygen to the fetus. Later, Ms. Mark relayed that she felt her baby's foot in her vagina (a "footling" breech). Sitting on her bathroom floor, with the umbilical cord protruding from the birth canal, Ms. Mark called 911. At 3:30 a.m., Emergency Medical Service personnel ("EMS") responded to Ms. Mark's home. When EMS reached Ms. Mark, they found her seated with approximately 15 inches of umbilical cord exposed. Initially, EMS was unable to feel a pulse in the umbilical cord. Once Ms. Mark was lifted and repositioned onto a stretcher, however, EMS was able to detect a faint pulse in the cord. EMS also noted that Ms. Mark was experiencing contractions "2 minutes apart." EMS transported Ms. Mark, in an ambulance, to Winter Park Hospital. EMS departed Ms. Mark's home at 3:41 a.m., and arrived at Winter Park Hospital at 3:53 a.m. At 3:58 a.m., Ms. Mark reached the Labor and Delivery Operating Room. There, she underwent an emergency C-section. Prior to the operation, the triage nurse palpated pulsation in the prolapsed cord. Ms. Mark was still experiencing contractions at two to three minutes apart. Dr. Cabrera conducted the emergency C-section. Ashton was delivered at 4:04 a.m. Dr. Cabrera's notes record "fetal distress cord prolapse, fetal malposition footling breech." A "footling breech" indicates that one or both of the baby's feet were positioned in the birth canal instead of the pelvis. Upon Ashton's delivery, Winter Park Hospital initiated a "Code Blue." Dr. Cabrera immediately started emergency resuscitative measures. At delivery, Ashton was not breathing, with a recorded heart rate of only 30 beats per minute. Ashton required full cardiorespiratory resuscitation. Ashton was emergently intubated at 4:06 a.m. Chest compressions were initiated "@ 20-30 seconds of life" and stopped at 4:08 a.m. At 4:08 a.m., Ashton's heart rate had reached 104 beats per minute. The Code Blue lasted from 4:04 a.m. to 4:29 a.m. By 4:29 a.m., Ashton's heart rate had risen to 144 beats per minute. The last oxygen saturation level recorded during the Code Blue was 77 percent at 4:19 a.m., indicating severe hypoxia. ("Hypoxia" means partial loss of oxygen to the fetus. "Anoxia" means total loss of oxygen to the fetus. The normal oxygen saturation range is 97-100 percent.) Ashton's APGAR ("Appearance, Pulse, Grimace, Activity, Respiration") scores following delivery were 1/2/4/4 at 1, 5, 10, and 15 minutes, respectively. (Scores of 7 to 10 are considered normal.) At 4:29 a.m., Ashton was transferred to the Neonatal Intensive Care Unit ("NICU"). Ashton was still unable to breath on his own. NICU noted "no respiratory effort and seizures." NICU placed Ashton on a mechanical ventilator in a continued effort to resuscitate him. At 4:41 a.m., the initial Arterial Blood Gas ("ABG") Report showed that Ashton was experiencing severe metabolic acidosis. The ABG Report recorded a pH level of 6.809 (critical) with a base excess of negative 25. This score signified a severely acidotic child with both a metabolic and respiratory acidotic condition. The acidotic condition required immediate medical treatment to correct. At 5:14 a.m., approximately 70 minutes after Ashton's birth, a second ABG Report showed a pH level of 7.034 (critical) with a base excess of negative 19. These values indicated that Ashton was continuing to experience severe metabolic acidosis. At 7:15 a.m., Ashton was transferred to the NICU at Florida Hospital Orlando. Although Ashton's oxygen saturation level had reached 99 percent, he was still unable to breathe on his own. He remained on a ventilator. Ashton also experienced repeated seizure activity. A progress report on January 21, 2018 (two days after his delivery), noted two episodes of seizures on that day. Ashton remained on a ventilator until January 26, 2018 (seven days after his delivery), when he was extubated. Petitioners argue that Ashton did not suffer a "birth- related neurological injury" which would entitle him to an award under the Plan. Section 766.302(2) defines the term to mean: njury to the brain or spinal cord of a live infant weighing at least 2,500 grams for a single gestation . . . caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate postdelivery period in a hospital, which renders the infant permanently and substantially mentally and physically impaired. Petitioners do not dispute that Ashton's case presents an injury to the brain of a live infant weighing at least 2,500 grams. Neither do Petitioners contest that Ashton's injury was caused by oxygen deprivation which renders him permanently and substantially mentally and physically impaired. What Petitioners challenge is whether Ashton's injury occurred "in the course of labor, delivery, or resuscitation in the immediate postdelivery period." Petitioners assert that Ashton's neurological impairment directly resulted from the umbilical cord prolapse in Ms. Mark's home at 3:19 a.m. Petitioners contend that Ashton's brain injury (due to oxygen deprivation) manifested before the time Ms. Mark reached Winter Park Hospital (3:53 a.m.). Consequently, Ashton's injury did not develop during his delivery at 4:04 a.m. or any subsequent postdelivery resuscitation efforts. Petitioners further argue that Ms. Mark was never in labor at any point during Ashton's birth. Therefore, they contend that Ashton's brain injury did not occur "in the course of labor, delivery, or resuscitation," and Ashton does not qualify for coverage under the Plan. To support their argument, at the final hearing, Petitioners presented the (deposition) testimony of Jason James, M.D., and Ariel Sherbany, M.D. Dr. James is a board-certified obstetrician/ gynecologist. Dr. James testified that, in his opinion, Ashton did not sustain a qualifying "birth-related" injury because Ms. Mark was not in labor at any point prior to Ashton's delivery at 4:04 a.m. Initially, Dr. James commented that it is "impossible to say" with any certainty whether Ms. Mark was in labor at the time of the umbilical cord prolapse at her home or prior to Ashton's delivery. Dr. James defined labor as "progressive cervical change in response to contractions." He relayed that, "In order for me to say a patient's in labor, I would need to see progressive cervical change in the presence of contractions, and we don't see that." Dr. James explained that, even with Ms. Mark dilated at one centimeter at Winnie Palmer, he saw "no documentation of any cervical change, whether by the EMS or by the hospital staff at Winter Park." Dr. James further expounded that the 100 percent effacement observed at Winnie Palmer was not necessarily related to labor. "Effacement is one of the cervical changes that we do see, but there are things that can cause cervical effacement that are not associated with labor." Accordingly, Dr. James did not see sufficient evidence to conclude that Ms. Mark was in labor before Ashton's delivery. Regarding the exact time Ashton's brain injury occurred, Dr. James testified that Ashton's brain injury resulted from oxygen deprivation due to the umbilical cord prolapse. He opined that the majority of the oxygen deprivation occurred during the 34 minutes from the "moments . . . the cord prolapse occurred" (3:19 a.m.) to the time Ms. Mark arrived at Winter Park Hospital (3:53 a.m.). Dr. James stated that: [T]he amount of brain damage that occurred prior to even the patient arriving at the hospital was substantial and permanent, and I think that the die was cast. . . . Was there ongoing and further damage? Yes. I will agree that there was ongoing and further damage, but I think that to say that that was the portion that resulted in permanent impairment is a mischaracterization. Accordingly, Dr. James supported Petitioners' position that Ashton's brain injury did not occur in the course of labor, delivery, or resuscitation in the immediate postdelivery period because "this baby already had substantial and permanent brain damage on arrival." Despite this assertion, Dr. James conceded that Ashton did suffer oxygen deprivation during the 11 minutes between the time Ms. Mark was admitted to Winter Park Hospital (3:53 a.m.) and his delivery at 4:04 a.m. Dr. James also accepted that Ashton continued to incur brain damage through the one hour and 10-minute time frame after his birth.4/ Dr. James further acknowledged that the hypoxia (partial lack of oxygen) Ashton experienced after 3:53 a.m. could have resulted in significant brain impairment. Finally, Dr. James disclosed that, in his opinion, Ashton was never anoxic (total lack of oxygen to the fetus) during the 34 minutes prior to Ms. Mark's arrival at Winter Park Hospital. Dr. Sherbany is a pediatric neurologist. Dr. Sherbany offered no opinion as to whether Ms. Mark was actually in labor at the time of the umbilical cord prolapse. Regarding the time period during which Ashton's brain injury due to oxygen deprivation occurred, Dr. Sherbany testified that Ashton's "brain-damaged fate was already predetermined before he arrived." Dr. Sherbany believed that the umbilical cord prolapse caused anoxia, or complete loss of oxygen to the fetus. Dr. Sherbany opined that this period of anoxia lasted 11 minutes until EMS repositioned Ms. Mark on a stretcher. Thereafter, the fetus experienced hypoxia (partial loss of oxygen) until Ms. Mark was admitted to the hospital. Dr. Sherbany explained that the "bulk of [Ashton's] oxygen deprivation really occurred" during the 34-minute time period before Ms. Mark presented at Winter Park Hospital. Dr. Sherbany expressed that, "The damage was determined at the time of that anoxic event. . . . In those 34 minutes, basically, this unfortunate child suffered his fate." In Dr. Sherbany's opinion, Ashton sustained the "majority of the insult to the brain stem . . . during that anoxic period." Like Dr. James, however, Dr. Sherbany conceded that Ashton continued to suffer oxygen deprivation, which resulted in additional brain injury, in the first 11 minutes after Ms. Mark arrived at Winter Park Hospital up to and through the four minutes of cardiac massage administered to Ashton after his delivery. Although Dr. Sherbany limited the immediate postdelivery resuscitation period to four minutes after birth, he acknowledged that Ashton was not medically stable until he was transported to the NICU unit at Florida Hospital Orlando at 7:15 a.m., three hours and 11 minutes after delivery. Dr. Sherbany also recognized that Ashton did not breathe on his own, without the assistance of a mechanical ventilator, for six days after his birth. Upon receiving Petitioners' Petition for NICA benefits, NICA conducted an evaluation to determine whether Petitioners' claim was compensable under the Plan. Unlike Petitioners, however, NICA concluded that Ashton did suffer a "birth-related neurological injury" within the meaning of section 766.302(2) and should be covered by the Plan. NICA does not dispute Petitioners' claim that Ashton suffered oxygen deprivation beginning as early as 3:19 a.m. (the moment of the umbilical cord prolapse) through 3:53 a.m. (All medical experts agree that Ashton experienced oxygen deprivation, as well as brain injury, between 3:19 a.m. and 3:53 a.m.) However, NICA asserts that Ms. Mark was in labor at the time of the cord prolapse. NICA also argues that Ashton continued to experience oxygen deprivation (which resulted in brain injury) through his delivery and postdelivery resuscitation at Winter Park Hospital. Therefore, NICA contends that Ashton's medical condition meets the statutory definition of "birth-related neurological injury" because his neurological injury occurred "in the course of labor, delivery, or resuscitation." To support its position, NICA presented the (deposition) testimony of Donald C. Willis, M.D., and Laufey Y. Sigurdardottir, M.D. Dr. Willis is board-certified in both obstetrics and maternal fetal medicine. Dr. Willis opined, within his medical expertise, that Ms. Mark went into labor shortly before or just after 3:19 a.m. Dr. Willis explained that "when EMS came [at 3:30 a.m.], [Ms. Mark] was having regular contractions, so I would assume that she was either in labor before that time or labor initiated with rupture of the membranes. . . . I would assume that her labor began somewhere right around 3:19 a.m." Dr. Willis concurred with Petitioners' medical experts that oxygen deprivation occurred at the moment of the umbilical cord prolapse at 3:19 a.m. Dr. Willis explained that "oxygen deprivation can lead to brain injury." Accordingly, Dr. Willis agreed that "there was some degree of brain injury [to Ashton] during that time period [3:19 a.m. through 3:53 a.m.]." However, unlike Dr. James and Dr. Sherbany, Dr. Willis declared that Ashton experienced an ongoing and continuing injury from the cord prolapse through at least 70 minutes after he was delivered at 4:04 a.m. Dr. Willis explained that oxygen deprivation continues until the oxygen returns to the bloodstream and reaches the organs and tissues. Consequently, Ashton's neurological injury progressed through his delivery and into the immediate postdelivery resuscitation period, at least through the time that Ashton continued to experience metabolic acidosis (5:14 a.m.). Accordingly, in Dr. Willis' opinion, Ashton's brain injury due to oxygen deprivation undoubtedly occurred during the labor, delivery, and the immediate postdelivery resuscitation period. However, while agreeing that Ashton began experiencing oxygen deprivation with the umbilical cord prolapse (3:19 a.m.), Dr. Willis testified that he did not "have any way to gauge" the amount of oxygen deprivation between 3:19 a.m. and 3:53 a.m. Therefore, he would not quantify when exactly Ashton's brain injury reached the level of permanent and substantial mental and physical impairment. On the other hand, Dr. Willis was certain Ashton continued to suffer brain injury due to oxygen deprivation during the resuscitation efforts in the immediate postdelivery period. Finally, Dr. Willis refuted Dr. Sherbany's statement that Ashton experienced complete anoxia for any prolonged period (11 minutes) after the umbilical cord prolapse. Dr. Willis did not believe that Ashton would have lived through that situation. Dr. Sigurdardottir is a pediatric neurologist. Alone among the expert witnesses, Dr. Sigurdardottir performed an independent medical evaluation of Ashton on June 27, 2018. Similar to Dr. Willis, Dr. Sigurdardottir testified that the "very, very substantial part" of Ashton's brain injury occurred at Winter Park Hospital in the final couple of minutes just prior to his delivery. Dr. Sigurdardottir declared that Ashton endured a continuum of brain injury due to oxygen deprivation. Dr. Sigurdardottir explained that brain injuries from oxygen deprivation occur exponentially, with the most critical period of injury "at the tail end of the hypoxic ischemic event." Dr. Sigurdardottir opined that the most severe part of Ashton's neurological injury occurred in the few minutes right before his delivery, and extended through the immediate post resuscitative period when Ashton experienced metabolic acidosis. Dr. Sigurdardottir further stated that Ashton's brain injury continued to evolve "within the first week" of his life, when he was most unstable. Dr. Sigurdardottir also commented that, given that hypoxia existed for some undetermined time prior to Ms. Mark's arrival at a hospital, it is difficult, if not impossible, to determine the full extent of the oxygen deprivation that occurred prior to 3:53 a.m. Therefore, it is difficult, if not impossible, to conclude that Ashton incurred a permanent and substantial brain injury prior to his delivery. Accordingly, Dr. Sigurdardottir concluded that Ashton's irreversible brain injury occurred during the final minutes prior to his birth at Winter Park Hospital, and in the hours and days after his delivery. In addition, contrary to Dr. Sherbany and similar to Dr. Willis, Dr. Sigurdardottir unequivocally stated that Ashton did not experience complete lack of oxygen (anoxia) prior to his delivery. Dr. Sigurdardottir rejected any suggestion that the fetus had no heartbeat from 3:19 a.m. until EMS felt a pulse around 3:31 a.m. Dr. Sigurdardottir explained that if Ashton had no heartbeat for 12 minutes prior to his birth, then relieving pressure on the umbilical cord would not have made a difference; Ashton would have been dead at his delivery. However, because EMS was able to detect a pulse after repositioning Ms. Mark on the stretcher, Dr. Sigurdardottir believed that Ashton's heart was beating between 3:19 a.m. and 3:31 a.m. Dr. Sigurdardottir further posited that, if Ashton had been utterly deprived of oxygen (anoxic) prior to 3:53 a.m., some meconium would have been present in the amniotic fluid. However, the EMS personnel who first treated Ms. Mark did not document any meconium from the rupture of membranes. In addition, the operative report from Ashton's delivery at Winter Park Hospital noted that the amniotic fluid was "clear." Therefore, Dr. Sigurdardottir refuted Dr. Sherbany's conclusion that Ashton experienced anoxia (total loss of oxygen) rather than hypoxia (partial loss of oxygen). Winnie Palmer joined NICA in arguing that Ashton suffered a "birth-related neurological injury" as defined in section 766.302. Winnie Palmer presented the expert (deposition) testimony of Donald Null, M.D., and Harry Farb, M.D. Dr. Null is a board-certified neonatologist. In his practice, Dr. Null provides care and treatment to critically ill infants just after delivery. In Dr. Null's opinion, Ms. Mark was experiencing some form of labor, though not "active" labor, when she visited Winnie Palmer at 1:11 a.m. on January 19, 2018. Dr. Null based his opinion on the fact that Ms. Mark was noted to have contractions and "minor" changes in her cervix. Dr. Null explained that active labor is when contractions start happening at a regular and consistent basis, and there is a change in the cervix. Dr. Null believed that Winnie Palmer released Ms. Mark at 2:33 a.m. because her contractions and cervical changes were not progressing. Dr. Null further remarked that Ms. Mark was clearly in labor at the time she presented to Winter Park Hospital at 3:53 a.m. However, Dr. Null qualified his comment by conceding that "I don't really have an opinion of when [Ms. Mark] was or wasn't in labor." Regarding the timing of Ashton's neurologic injury, in Dr. Null's opinion, Ashton had only suffered "mild insult" when Ms. Mark arrived at Winter Park Hospital. Dr. Null explained that a footling breech typically does not result in "total occlusion" of the umbilical cord, only "partial occlusion." In other words, Ashton only experienced hypoxia (partial loss of oxygen to the fetus) not anoxia (total loss of oxygen to the fetus) prior to 3:53 a.m. Dr. Null further opined that the hypoxia was not as severe before Ms. Mark's admission to the hospital as it was during the delivery and resuscitation efforts. Dr. Null testified that Ashton suffered a continuing brain injury from the time of the cord prolapse (3:19 a.m.) until his metabolic acidosis was rectified approximately 70 minutes after his delivery (5:14 a.m.). Dr. Null concluded that Ashton suffered a profound neurological injury, which he referred to as hypoxic ischemic encephalopathy ("HIE"), from the time Ms. Mark arrived at Winter Park Hospital until the time the postdelivery resuscitation efforts concluded. Dr. Null based his opinion on the fact that Ashton's heartrate was measured at 30 beats per minute at delivery, and was most likely at that level at the time Ms. Mark arrived at the hospital. Dr. Null also referred to the fact that Ashton required continuing resuscitation to correct his metabolic acidosis. Dr. Null opined that the HIE was significant enough to cause Ashton's substantial brain injury. Agreeing with Dr. Willis, Dr. Null testified that it is "impossible to quantify" the extent of the oxygen deprivation Ashton suffered between 3:19 a.m. and 3:53 a.m. However, agreeing with Dr. Sigurdardottir, Dr. Null testified that if Ashton had experienced "profound" oxygen deprivation (anoxia) or "a very profound injury prior to arrival" at Winter Park Hospital, he "probably would not have survived the rest of the labor and the resuscitation." Therefore, in concert with Dr. Sigurdardottir's opinion, Dr. Null believed that Ashton sustained the "more substantial portion of his brain injury" after the time Ms. Mark presented at the hospital (3:53 a.m.) and during delivery and postdelivery resuscitation. Dr. Farb is board-certified in both obstetrics and maternal fetal medicine. In Dr. Farb's opinion, the vast majority of Ashton's brain injury occurred after Ms. Mark arrived at Winter Park Hospital. Initially, Dr. Farb testified that Ms. Mark was in labor, "with a qualifier," when she arrived at Winter Park Hospital at 3:53 a.m. Dr. Farb defined labor as "contractions in association with cervical dilation [or change]." Dr. Farb commented that Ms. Mark's "contractions every two minutes could certainly be consistent with labor." However, he did not have any information on the presence of cervical change. Therefore, Dr. Farb issued a "qualified" conclusion that, if Ms. Mark was not in the active phase of labor, then she was at least in the "latent phase of labor." Regarding when Ashton's neurological injury occurred, Dr. Farb acknowledged that some hypoxia occurred prior to Ms. Mark's arrival at the hospital. However, Dr. Farb agreed with the assessments of Dr. Willis, Dr. Sigurdardottir, and Dr. Null that the actual amount of oxygen deprivation cannot be determined. That being said, Dr. Farb, again agreeing with Dr. Willis, Dr. Sigurdardottir, and Dr. Null, believed that "the substantial part of the injury occurred after arrival [at 3:53 a.m.] and into the immediate neonatal resuscitation period." Dr. Farb estimated that "90 percent of the injury at least occurred at and after admission to the hospital." Dr. Farb based his opinion on several factors, including: a footling breech does not cause total umbilical cord occlusion; Ashton's condition worsened from the time of his presentation to the hospital (3:53 a.m.) until delivery (4:04 a.m.); and Ashton experienced "continuous seizure activity" for at least 70 minutes after delivery (through 5:14 a.m.). Dr. Farb further commented that the second ABG draw at 5:14 a.m. showed that Ashton was still severely acidotic, which meant that his brain injury was still progressing. Dr. Farb also explained that a fetus does not immediately suffer a neurological injury at the moment of an umbilical cord prolapse. A fetus has a reserve of oxygen that must be depleted before injury to the brain occurs. Dr. Farb explained that oxygen deprivation (and any resulting brain injury) may not have commenced in Ashton until 10 to 18 minutes after the ruptured membranes and prolapsed cord. Like Dr. Sigurdardottir, Dr. Farb explained that oxygen deprivation is progressive in nature and exacerbates over time. Accordingly, "the severity of the oxygen deprivation was much worse at [Ms. Mark's] admission and [Ashton's] delivery." There was no question in Dr. Farb's mind "that the severity of the oxygen deprivation and the brain injury . . . occurs much closer to the time of delivery because things are progressive and as well as continuing in the immediate resuscitation period." Specifically, Ashton's brain injury continued to occur up to an hour and 10 minutes after his delivery as revealed by his severe metabolic acidosis at 5:14 a.m. In addition, Dr. Farb stated that Ashton's brain was also injured due to constant seizure episodes after his delivery while he was still being resuscitated. Based on the competent substantial evidence in the record, the preponderance of the evidence establishes that Ashton suffered a "birth-related neurological injury" as defined in section 766.302(2). The evidence demonstrates that Ashton began experiencing oxygen deprivation at the time of the umbilical cord prolapse which continued through delivery and immediate postdelivery resuscitation. This oxygen deprivation caused Ashton to sustain a brain injury which has rendered him permanently and substantially mentally and physically impaired. The evidence does not prove that Ms. Mark was in labor prior to Ashton's birth. However, based on the more persuasive medical testimony, the evidence establishes that Ashton suffered injury to his brain, caused by oxygen deprivation, in the course of his delivery and resuscitation in the immediate postdelivery period at Winter Park Hospital. Accordingly, Ashton is eligible for an award of compensation under the Plan.
The Issue Was Petitioner properly graded and given appropriate credit for his answers on the July, 1990 Florida Podiatric Medicine Licensure Examination (Florida Podiatry Examination).
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant findings of fact are made: At all times pertinent to the issues herein, Petitioner, Paul L. Sheehy, Jr., candidate No. 20017, was a candidate for licensure by examination as a Podiatrist, and the Board of Podiatry, (Board), was and is the state agency in Florida responsible for the licensing of Podiatrists and the regulation of the Practice of podiatric medicine in this state. Petitioner sat for the July, 1990 Florida Podiatry Examination on July 27, 1991. Petitioner obtained a score of 70.0 percent, representing 210 correct answers. A passing grade requires a score of 72 percent, representing 216 correct answers. Shortly before the beginning of the hearing, Respondent agreed to give Petitioner credit for questions 16 and 180 of Clinical I of the examination thereby raising his total score to 70.666 percent. At the beginning of the hearing, Petitioner withdrew his challenge to questions 22, 37, 87, 89, 104, 149, 176 and 178 of Clinical I of the examination and questions 3, 16, 22, 50, 67 and 53 of Clinical II of the examination. During the hearing Petitioner withdrew his challenge to question 27 of Clinical I and question 12 of Clinical II of the examination, leaving only his challenge to questions 103, 114, 138, 144 of Clinical I of the examination. The parties stipulated that the Petitioner was qualified and met all the requirements to sit for the July, 1990 Florida Podiatry Examination, and that Petitioner timely received a copy of the July 1990, Podiatric Medicine Licensure Examination Candidate Information Booklet (booklet). There is a lack of competent substantial evidence in the record to establish that the Florida Podiatry Examination given on July 27, 1990 was misleading in that it tested subjects or disciplines not covered or contained in the booklet, or that it was prejudicial as applied to Petitioner. The first question at issue is question 103 of Clinical I which stated: CASE HISTORY 44 In the exhibit book are photographs for this examination. Identify the photograph in the respective exhibit. 103. Which of the following answer choices is the best description of exhibit #11? Ganglion Cyst Verruca Melanoma Kaposi's Sarcoma Petitioner answered, C, Melanoma and the Respondent's answer was, B, Verruca. Petitioner admitted that his answer was incorrect. However, Petitioner contends that the question comes within the area of histology, an area not specifically mentioned in the booklet to be covered by the examination. Therefore, he was mislead by the booklet into not studying the area of histology. While the booklet does not specifically mention histology as an area of study to be covered in the examination, there were several other areas of study listed in the booklet which conceivably would have covered this question. Therefore, there has been no showing that the Respondent's failure to specifically list histology as an area of study mislead or prejudiced the Petitioner. The second question at issue is question 114 which stated: CASE HISTORY 45 An elderly obese male presents with an acutely inflamed first metatarsophalangeal joint. The pain began late last night and he awoke in severe pain. His past medical history reveals two previous such occurrences which resolved and went un- treated. He reports a history of chronic renal disease and mild hypertension. He presently takes no medication and has no known allergies. He denies use of alcohol and tobacco. Physical exam reveals an acutely inflamed, edematous 1st MPJ. A 3mm ulceration is present dorsally with white, chalky material exiting the wound. Laboratory studies reveal a CBC within normal limits and an elevated uric acid of 9.0mg/100ml. 114. Which of the following would you expect to find on microscopy of the synovial fluid? trapezoidal-shaped violet crystals absence of leukocytes needle-like birefringent crystals reflective hexagonal crystals and many leukocytes Petitioner answered D, reflective hexagonal crystals and many leukocytes. The Respondent's answer was C, needle-like birefringent crystals. Petitioner contends that none of the answers offered were entirely correct but that answer D was the most correct, while answer C was incorrect. Case History 45 would describe gout and pseudogout, but the key is the description of the fluid removed from the joint which is a white, chalky material found only with gout. Additionally, gout produces needle-like crystals (urate) that are negatively birefringent when view under crossed polarizing filters attached to a microscope. Leukocytes would be present in this case history but it would not produce reflective hexagonal crystals or trapezoidal-shaped violet crystals. Answers A and B are entirely incorrect, and although the presence of leukocytes is correct, it is not relevant because leukocytes are a normally found in any infection. Therefore, answer C is the correct answer, notwithstanding the absence of the word negative proceeding the word birefringent. The third question at issue is question 138 which stated: CASE HISTORY 49 A 27 year old athletic individual presents with a severely painful and swollen right ankle following a basketball injury the day before. There is severe ecchymosis and blister formation about the ankle. X-rays reveal (1) a displaced oblique spiral fracture of the lateral malleolus which runs anterior-inferior to posterior-superior at the level of the syndesmosis (2) transverse fracture of medical malleolus. There is gross dislocation and mal position of the talus. 138. If the initial treatment above were to fail, then treatment should consist of: immediate open reduction. wait 4-6 days, then perform open reduction and internal fixation. open reduction contraindicated at any time with this type of fracture. fusion of ankle joint. Petitioner answered A, immediate open reduction and the Respondent's answer was B, wait 4-6 days, then perform open reduction and internal fixation. The correct initial treatment for the patient would have been attempted close reduction as indicated by the correct answer to question 137 which Petitioner answered correctly. An attempted close reduction is an attempt to correctly align the fractured bone by manipulation as opposed to surgically opening the area and aligning the bone visually by touch which is the open reduction and internal fixation procedure. After an attempted alignment of the bone, an x-ray will determine if there is proper alignment. If there is proper alignment, then the area is immobilized with a cast or some other device until the fracture heals. If the x-ray shows that proper alignment of the bone has not been obtained (the initial treatment has failed) then open reduction and internal fixation would be proper provided the swelling, ecchymosis and blistering are not present. Otherwise, as in this case, the proper method would be to wait a period of time, 4-6 days, for the swelling, ecchymosis and blistering to go away. Petitioner's contention that the swelling had gone down since there had been immobilization of the area with a cast, posterior splint or unna boot and a waiting period is without merit since those devices would not have been used before determining by x-rays that the initial treatment (closed reduction) had failed. The fourth and last question at issue in question 144 which stated: CASE HISTORY 50 A patient presents with a painful left ankle. The pain occurs following ambulation and is relieved by rest. There is minimal periartic- ular atrophy and the joint is slightly warm. X-rays reveal non-uniform joint narrowing, subchondral sclerosis and marginal osteophytes. 144. It can be expected that the patient will favorably respond to treatment but may experience flareups. significant cartilage damage will occur. total joint replacement will be required. total remission can be expected following treatment. Petitioner answered B, significant cartilage damage will occur and Respondent's answer was A, that the patient will favorably respond to treatment but may experience flareups. There were a series of questions preceding this question concerning the patient in Case History 50. The first question asked for a diagnosis which the Petitioner correctly answered as osteoarthritis. The second question concerned advising the patient on treatment which the Petitioner answered correctly by giving instructions on protecting the joint and taking simple analgesics. The third question concerned activity levels such as jogging and climbing steps which Petitioner answered correctly by advising to avoid squatting. However, in selecting B as the answer to question 144 the Petitioner did not consider the suggested treatment and advise given in the previous answers. His reasoning was that he could not assume that the patient would follow his suggested treatment or advise on prevention and activity. Additionally, the Petitioner felt that other factors such as the patient's age, weight, general health, level of activity and occupation that were missing from the case history were necessary to make a proper evaluation of whether the patient would respond favorably to treatment. Respondent admitted that either answer A or B would be correct but he picked B because he knew the disease was progressive and in time would get worse causing significant cartilage damage. Osteoarthritis is a degenerative joint disease that is not uniformly progressive that responds to treatment but cannot be cured. There will be recurring episodes of pain (flareups) triggered by factors such as the weather or a person's activity. Based on the factors in the above case history, there is sufficient evidence to show that the patient will favorably respond to treatment but may experience flareups. It was reasonable and logical for the Respondent to assume that the Petitioner in answering question 14 would consider his preceding answers and assume that the patient would follow the suggested treatment and advice. There is a lack of competent substantial evidence in the record to establish that significant cartilage damage would occur based on the facts given in Case History 50. There is a lack of competent substantial evidence in the record to establish that the grades which the Petitioner received on the July, 1990 Florida Podiatry Examination were incorrect, unfair, or invalid, or that the examination, and subsequent review session, were administered in an arbitrary or capricious manner.
Recommendation Based upon the foregoing, it is recommended that Respondent enter a Final Order dismissing the Petitioner's challenge to the grade he received on the July 1990, Florida Podiatry Examination. RECOMMENDED this 18th day of September, 1991, in Tallahassee, Florida. WILLIAM R. CAVE Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 18th day of September, 1991. APPENDIX TO RECOMMENDED ORDER, CASE NO. 91-2118 The following contributes my specific rulings pursuant to Section 120- 59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties in the case. Rulings on Proposed Finding of Fact Submitted by the Petitioner Adopted in substance in Findings of Fact 1 and 4. Adopted in substance in Finding of Fact 4. Rejected as not supported by competent substantial evidence in the record. Rulings on Proposed Findings of Fact Submitted by the Respondent Adopted in substance in Findings of Fact 1 and 2. Adopted in substance in Finding of Fact 2. Adopted in substance in Finding of Fact 3. 4.-6. Adopted in substance in Findings of Fact 6, 7, and 8, respectively. 7. Adopted in substance in Findings of Fact 9 and 10. COPIES FURNISHED: Hewitt E. Smith, Esquire P.O. Box 76081 Tampa, FL 33675 Vytas J. Urba, Esquire Department of Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792 Patricia Guilford, Executive Director Board of Podiatry 1940 North Monroe Street Tallahassee, FL 32399-0792 Jack McRay, General Counsel Department of Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792
The Issue The issue in this case is whether Kayla Mackenzie Stowers sustained a birth-related neurological injury.
Findings Of Fact Tatiana C. Stowers and Robert M. Stowers are the natural parents of Kayla Mackenzie Stowers, a minor. Kayla was born a live infant on October 12, 2009, at Orange Park Medical Center, a licensed hospital located in Orange Park Florida. Eric J. Edelenbos, M.D., provided obstetric services at the birth of Kayla, and at all times material to this proceeding, was a “participating physician” as defined in section 766.302(7), Florida Statutes. Kayla weighed 3,078 grams at birth. On October 12, 2009, Mrs. Stowers, who was at full term, was admitted to Orange Park Medical Center at 6:28 a.m., for induction of labor. Her prenatal course had been uneventful. The baby?s baseline fetal heart rate on admission was 150 bpm, and the fetal heart rate monitor did not show any fetal distress during labor or delivery. At 8:05 a.m., Pitocin was administered to augment Mrs. Stowers? labor. During her labor, the dosage of Pitocin was increased. At 1:48 p.m., Dr. Edelenbos ruptured Mrs. Stowers? membranes, and the medical records indicate that the amniotic fluid was clear and odorless. At 9:40 p.m., Mrs. Stowers delivered Kayla by normal spontaneous vaginal delivery. At birth, Kayla?s mouth and nose were suctioned, but no other resuscitative measures were needed or administered in the delivery room. No complications were noted at her birth, and she was in stable condition. Kayla?s Apgar scores at one and five minutes were eight and nine respectively. At 10:30 p.m., Kayla was noted to have respiratory distress. Her left nasal passage was tight and her right nare was patent. She was transferred to the hospital?s neonatal intensive care unit. On October 13, 2009, at 12:05 a.m., Kayla was placed on a nasal cannula and an IV was started. Antibiotics were given at 12:20 p.m., and Neo-Synephrine was administered for nasal stuffiness. By 3:45 p.m., on October 13, 2009, Kayla had increased retractions and grunting and was placed on neonatal CPAP at 100% oxygen. During the evening of October 13, 2009, Kayla experienced two apneic episodes with jerking movements of her arms and leg. On October 14, 2009, Kayla was on CPAP for four hours and then intubated due to the apneic episodes the previous evening. A chest X-ray taken of Kayla on October 13, 2009, was within normal limits. On October 14, 2009, Kayla had a normal neonatal head ultrasound. On October 15, 2009, it was noted that Kayla had not experienced any abnormal movements for 24 hours. At 6:00 p.m., on October 17, 2009, Kayla experienced periodic episodes of jerking of hands and legs, in addition to the arching of her back. On October 18, 2009, Kayla had jerky movements of all extremities, including her eyes rolling back. The movements stopped with restraint, but were not typical seizure-like movements. On October 19, 2009, due to suspected seizures, respiratory distress, and suspected sepsis, Kayla was transferred from Orange Park Medical Center to Wolfson Children?s Hospital for further workup. An EEG performed on Kayla on October 20, 2009, was within normal limits. A follow-up video EEG on November 4, 2009, was normal. An MRI was done on Kayla on October 21, 2009, and the followings findings were reported: Moderate image degradation secondary to patient?s motions. Normal variant cavum septus pellucidum and cavas vergae. Prominent extra-axial fluid at the anterior aspect of both middle fossae, and with „apparent? suboptimal opoerculation of the Sylvian fissures ? clinical signicance. Followup US may be helpful for further evaluation. Remainder of the examination appears otherwise unremarkable. Kayla?s attending physician at Wolfson Children?s Hospital indicated in her discharge summary dated November 10, 2009, that the MRI was normal. On December 9, 2009, Kayla was taken to the emergency room at Wolfson Children?s Hospital. While in the emergency room, Kayla experienced apneic episodes that required intubation. She was admitted to Wolfson Children?s Hospital. While admitted to Wolfson Children's Hospital, Kayla had abnormal movements that were nonspecific and not due to seizures. Kayla was discharged on December 22, 2009. In his discharge summary, Clifford David, M.D., summarized the hospital course as it related to the seizure-like activities. Neurology-wise, the patient was again worked up for this possible seizure-like activity, which was possibly due to reflux. This workup included another EEG and MRI. The CT of the head that was done on admission was reported as positive for a remote area of ischemia involving the basal ganglia but repeat MRI on admission showed no area of acute ischemia. The patient was witnessed to have back arching and head extension with some clenching of the arms and chest, again unsure whether this was seizure versus reflux versus obstructive airway. Neurology examined the patient and EEG showed no epileptiform discharges although was limited secondary to movement artifact. The repeat MRI referenced in Dr. David?s discharge summary was done on December 12, 2009. The findings of this MRI indicated that there was no acute ischemic event. Respondent retained Donald C. Willis, M.D., to review the medical records for Kayla. Dr. Willis reviewed the fetal heart rates of Kayla as recorded by the fetal heart rate monitor during labor. It is Dr. Willis? opinion that the fetal heart rate monitor did not show any fetal distress during labor. On the issue of whether there was an obstetrical event which resulted in loss of oxygen or mechanical trauma to Kayla during labor or delivery, Dr. Willis opined: In summary, there was no fetal distress during labor. The baby was not in distress at birth. Apgar scores were 8/9. Immediately after delivery, the baby was placed on the mother?s abdomen for bonding. The newborn course was complicated by a complex history of apnea episodes, respiratory distress and possible seizures. EEG?s and MRI studies were normal. There was no apparent obstetrical event that resulted in loss of oxygen or mechanical trauma to the baby?s brain during labor or delivery. Raymond J. Fernandez, M.D., a pediatric neurologist, reviewed Kayla?s medical records and examined Kayla on April 30, 2013. He opined as follows: There is ample evidence for substantial mental and motor impairment, but this is of unknown etiology. There is no evidence in the medical record for oxygen deprivation or mechanical injury of brain or spinal cord during labor, delivery, or the immediate post delivery period that explains Kayla?s substantial and global impairment. Petitioners have presented no expert opinions that refute the opinions of Dr. Willis and Dr. Fernandez. The opinions of Dr. Willis and Dr. Fernandez that Kayla?s mental and motor impairments are not due to oxygen deprivation or mechanical injury of the brain or spinal cord during labor, delivery, or the immediate post delivery period are credited.
Findings Of Fact At all times material hereto, Respondent was a licensed medical doctor in the State of Florida having been issued License No. 0020340. Respondent specializes in the practice of ophthalmology, and is board-certified in that specialty. As indicated above, Respondent has been charged in a three-count complaint with various violations concerning his treatment of three patients. For purposes of clarity, the Findings of Fact section of this Recommended Order will, therefore, treat each such patient separately. ETTA ROSE Respondent first saw Etta Rose as a patient on March 17, 1980. At that time Ms. Rose gave a history of having had "floaters" in both eyes, in her left eye for three months and in her right eye for approximately the past three years. She also indicated a history of hypertension of five years duration. On her initial visit, Ms. Rose informed Respondent that she had last had an eye examination in December of 1978, but could not recall the name of the examining doctor. Upon physical examination on the initial visit of March 17, Respondent determined that the patient had intraocular pressures of 25 in her right eye and 26 in her left eye. In this connection, intraocular pressures of from 12 to 21 are considered roughly normal in a general patient population, and any readings above those levels are generally considered to be elevated. In addition to the above-noted intraocular pressures, Respondent also determined-on this initial visit that the patient had asymmetric nerve heads, the nerve heads in her left eye being markedly larger than those in the right. This degree of difference, according to Respondent's determination, could not be attributed to a congenital defect. Since this degree of differential in the size of the optic nerve heads occurs in less than one percent of the population, this fact, taken together with the patient's elevated intraocular pressures, resulted in Respondent's diagnosis of probable glaucoma. As a result of Respondent's physical findings as outlined above, together with the lack of information from prior treating physicians, Respondent determined that in order to avoid potentially irreversible damage to the patient's eyes, he needed to administer as high a dosage of medication to bring down the patient's intraocular pressures as rapidly as possible. Accordingly, on March 17, 1980, Respondent prescribed a one percent solution of pilocarpine to be administered to the patient's eyes every four hours. Pilocarpine is an old conservative glaucoma medication used specifically to reduce intraocular pressures. A one percent pilocarpine solution' is a relatively light dosage. Therefore, on March 20, 1980, Respondent increased the dosage of pilocarpine to two percent every four hours, and on March 24, 1980, again increased the dosage of pilocarpine to four percent every four hours. Additionally, on March 28, 1980, Respondent added the drug timolol to his attempted medical management of the patient's pressures. It is not medically advisable to start a patient directly on a four percent pilocarpine solution because of the distinct danger of side effects, such as headaches and dimness of vision. As a result, Respondent utilized a process known as "titrating," by starting the patient on a lowered dosage of medication, and rapidly bringing the patient to a maximum dosage, watching carefully during this period for evidence of side effects. The patient in this case apparently experienced no such ill side effects. During his second office visit with the patient on March 20, 1980, Respondent performed a gonioscopy to evaluate the angle where the patient's cornea touched near the iris. This procedure showed the patient to have wide open angles and no scarring. Respondent therefore concluded that the patient suffered from chronic open-angle glaucoma, which was consistent with his initial diagnosis on the first visit of March 17, 1980. On March 20, 1980, the patient's intraocular pressures were 21 in the right eye and 23 in the left eye. During the entire course of his treatment of this patient, Respondent saw the patient in his office on the following dates: March 17, 20, 24, and 28, 1980; April 3, 8, and 22, 1980; May 20, 1980; and June 24, 26, and 27, 1980. Because of the asymmetry in the patient's optic nerve heads, her elevated pressures, and her lack of medical history to demonstrate the progress, if any, of glaucoma, Respondent determined it to be necessary to develop as accurate a profile on the patient as quickly as possible. The purpose of these office visits, which occurred at different times during the day, was to approximate a "diurnal curve." A diurnal curve is a method for determining fluctuating intraocular pressures of a patient, and is customarily obtained by admitting the patient to a hospital, and checking pressures in the patient's eyes approximately every two hours over a 24-hour period. The purpose of the procedure is to obtain an accurate 24-hour reading of the patient's pressures, since pressures within the eye can fluctuate markedly during different times of the day. Respondent determined admitting Ms. Rose to the hospital to be impractical, and set upon a course of seeing her in his office on several rather closely spaced days at different times of the day in order to get a more accurate understanding of her condition. By the time Respondent last saw the patient in his office on June 26, 1980, the patient was on a four percent pilocarpine solution four times a day, .5 percent timolol, and diomox b.i.d., and her pressure in her left eye still remained 26. At that time Respondent determined that he had the option of continuing to carry the patient on these dosages of medication, in which case he determined that the patient would probably go on to progressive damage, or, alternatively, surgical intervention. Respondent determined this amount of medication to have maximized medical therapy and, as a result, recommended a trabeculectomy to attempt to lower the patient's pressures. This surgical recommendation was made on June 27, 1980, at which time Respondent invited the patient to seek a second opinion, recommending that she consult ophthalmologists at the Bascom Palmer Eye Institute at the University of Miami Medical School. The patient sought such an opinion, and elected not to undergo the surgery recommended by Respondent. As a result, the office visit of June 27, 1980, was the last time Respondent saw Etta Rose as a patient. Respondent's diagnosis of the patient at the last visit was chronic open-angle glaucoma that was uncontrollable on medical therapy. The patient was apparently seen by an ophithalmologist on May 15, 1981, and again in January of 1982. The physician who last examined the patient determined that the patient, although she had slightly elevated intraocular pressures, "probably" did not have glaucoma, but should be followed as a "glaucoma suspect" because of the difference in the size of her optic nerves. The record in this cause establishes that there are three parameters generally accepted for diagnosing glaucoma: intraocular pressures; visual fields; and the appearance of the optic nerve. As previously indicated pressures above 21 are generally considered elevated. Throughout Respondent's treatment of Ms. Rose it appears that her intraocular pressures were at all times elevated, and that the optic nerve heads in her left eye were markedly larger than those in her right eye. The record also demonstrates that she evidenced no visual field loss while being treated by Respondent or thereafter. A trabeculectomy is a surgical procedure used in the treatment of glaucoma as a last resort when all other treatment modalities have been exhausted. There is some degree of danger inherent in the procedure, and it is associated with a high failure and complication rate, and can lead to the formation of cataracts. As indicated above, Respondent is charged in the Administrative Complaint with requiring Ms. Rose to come to his office an excessive number of times, with prescribing excessive medication for her condition, and with recommending unnecessary surgery. With respect to the charge of requiring excessive office visits, it is specifically concluded that Respondent exercised that level of care, skill, and treatment which was reasonable under the circumstances given the fact that the patient had elevated intraocular pressures, asymmetric optic nerve heads, and was unable to furnish Respondent with a history that would justify less aggressive treatment than the methods employed by Respondent. Because of these factors, Respondent reasonably determined that the patient should be seen often during the initial stages of therapy particularly in order to evaluate fluctuations in the patient's intraocular pressures. At final hearing, Petitioner adduced credible testimony from two board-certified ophthalmologists that Respondent prescribed excessive medication to Ms. Rose over his period of treatment of that patient. Specifically, these physicians took exception to Respondent's increasing the dosages of pilocarpine from one percent to a four percent solution over an approximately 11-day period. These physicians felt the better practice would have been to proceed more slowly to determine how the patient's pressures were reacting to medication. Equally credible, however, was testimony from the Respondent himself and from another board-certified ophthalmologist that the procedure known as "titrating" whereby the patient is started on a lower dosage and worked to a higher dosage over a short span of time was also reasonable medical treatment under the circumstances. The patient was seen frequently so that any side effects from this increase in medication could be monitored by Respondent. In addition, because of the high degree of difference in the size of the optic nerve heads in the patient's two eyes, Respondent reasonably assumed that glaucoma, if it were present, had progressed to such an extent that it was necessary to get the patient's intraocular pressures under control as rapidly as possible. Respondent reasoned that, should the pressures be brought under control at a higher level of medication, the medication could always be cut back, whereas, if he proceeded more slowly irreversible damage might occur in the interim. This record simply reflects that reasonable ophthalmologists might disagree with respect to the proper administration of medication in this context and, as a result, it cannot be determined from this record that Respondent acted unreasonably in his course of prescribing medications to Etta Rose. Finally, Petitioner adduced credible testimony at final hearing that the trabeculectomy recommended by Respondent was improper because Respondent had not reached maximum medical management of the patients condition in that he had not utilized oral diuretics or epinephrine as treatment modalities. The reasoning here is that until maximum medical management proves unsuccessful in controlling a patient's pressures, a remedy as drastic as a trabeculectomy should not be utilized. Petitioner's witnesses testified that based on the patient's marginally elevated pressures and the fact that she demonstrated no visual field loss, surgical intervention was improper. Again, equally credible testimony from both the Respondent and another board-certified ophthalmologist called as a witness by Respondent establishes that an equally reasonable interpretation of the data available to Respondent was that the patient was, indeed, under maximum medical management, and her intraocular pressures had not responded appropriately to this treatment regime. Further, the record also establishes that it is very unusual to find the degree of difference in the size of the optic nerve heads in this patient without visual field loss. Patients who demonstrate this size differential without visual field loss often do not develop visual field loss until relatively late in the progress of the disease, but when that loss occurs it occurs abruptly and profoundly. Thus, it appears that the risk of performing a trabeculectomy had to be weighed against the danger of irreversible damage from the progress of glaucoma. Under these circumstances, it was reasonable for Respondent to recommend surgery. It should be noted also that at the time Respondent recommended the surgical procedure, he also advised the patient that she was free to seek a second opinion. In addition, Respondent also adduced credible testimony that based on the drugs which he had prescribed medical management of this patient's condition would not have been furthered by adding epinephrine to his course of treatment. Accordingly, the facts of record in this cause do not establish that Respondent caused Etta Rose to visit his office an excessive number of times, that he prescribed excessive medication for his treatment of that patient, or that unnecessary surgery was recommended by Respondent. ALBERT MILLER Respondent first saw Albert Miller as a patient on September 29, 1976. Upon physical examination of the patient, Respondent had no reason to suspect the presence of glaucoma. The patient was next seen on March 16, 1977, for a check of his retina because of his history of diabetes. In addition to diabetes, the patient also had a history of hypertension. There were no changes in the patient's condition on the March 16, 1977, visit, and Respondent instituted no treatment. The patient was next seen for an annual check on May 22, 1978. The patient's vision with his glasses had worsened in both eyes at that time. The patient's history indicates that the patient's diabetes had been high just two months prior to this examination. The diabetes had apparently also affected the patient's intraocular pressures because they were found to be 20 in both eyes on this examination, whereas they had been 17 in the right eye and 16 in the left eye on September 29, 1976, when the patient was first seen by Respondent. Respondent chose not to institute active treatment of the patient after the May 22, 1978, visit. The patient was next seen on July 17, 1979. At that time his pressures were still 20 in both eyes and Respondent noted some slight increase in cataract formation and the presence of retinal hemorrhages in the patient's right eye, indicating some diabetic retinal changes that could make the patient's eyes more susceptible to disease. The patient was next seen on July 15, 1980, at which time his intraocular pressures were measured to be 26 in the right eye and 24 in the left eye. Although there is a notation in Respondent's record that the patient was "squeezing," which can artificially elevate pressures, the Respondent testified without contradiction that the "squeezing" noted in his records did not affect the accuracy of these recorded pressures. As of the July 15, 1980, office visit, Respondent diagnosed the patient as a "glaucoma suspect," which is someone who, because of existing physical factors, runs a substantial chance of developing future glaucoma. As a result of this diagnosis, the Respondent scheduled the patient for visual fields on July 17, 1980, and a gonioscopy on July 18, 1980. Visual fields performed by Respondent showed visual field defects which were suggestive of actual visual field loss on threshold stimulus testing. As a result the Respondent concluded that the patient might already have had early visual field loss, and started the patient on a one percent pilocarpine solution in both eyes, every four hours. The patient was next seen on July 22, 1980, at which time his pressures were measured to be 22 in the right eye and 20 in the left eye at 1:35 p.m. The patient was next seen on July 25, 1980, at which time his pressures were 24 in the right eye and 18 in the left eye. Respondent did not feel that a pressure of 24 in the right eye was adequate medical control, so he increased the patient's medication to two percent pilocarpine solution, and scheduled the patient to return on July 29, 1980. The July 25, 1980, pressure readings were conducted at 8:55 a.m., so the patient was scheduled to return in the early afternoon on July 29, 1980, in order to obtain pressure readings at a different time of day. On that occasion, the patient's pressures were 20 in the right eye and 22 in the left eye, which Respondent still determined not to be adequate medical management. Accordingly, Respondent increased the dosage of pilocarpine to a four percent solution. The patient was next seen on August 1, 1980, at which time his pressures were 21 in the right eye and 22 in the left eye. Respondent concluded the reading of 22 in the left eye, in light of possible visual field defects, was not adequate medical management, so he added 0.25 percent timolol to the four percent pilocarpine prescription. The effect of timolol is usually observable within 48 hours. The patient was next seen on August 5, 1980, at which time his pressures were 17 in the right eye and 18 in the left eye. Respondent was pleased with the lowering of the patient's pressures, and scheduled the patient to return on August 11, 1980. At that time the patient's pressure was 20 in both eyes. Respondent was pleased with these results, and felt that he did not need to see the patient again for a two-week period. The patient never returned. The last time the patient was seen by Respondent on August 11, 1980, the Respondent's diagnosis was "glaucoma suspect," although Respondent felt that he needed to follow the patient longer to monitor his visual fields and optic nerve heads. However, with the patient's history of diabetes, myopia, hypertension, and Respondent's determination that he showed early visual field changes, Respondent felt confident with his final diagnosis of "glaucoma suspect." The patient was subsequently examined by another ophthalmologist in the Fort Lauderdale area on August 28, 1980. At that time the patient's pressures were 19 in the right eye and 20 in the left eye. The patient was given a complete examination, which showed presence of dot and blot hemorrhages throughout the entire retina of both eyes, which was to be expected of a patient who was diabetic for the past 15 years, and had been taking insulin for that condition for the past eight years. The patient's optic nerves were normal, and the patient's cup to disc ratio was also normal. Because the patient's optic nerves were normal, he was taken off the pilocarpine which had been prescribed for him by the Respondent. A visual field test was also administered to the patient to determine the presence of any visual field loss secondary to glaucoma, but that test indicated normal vision. The normal cup to disc ratio found by the subsequent treating physician in examining the patient has remained stable throughout his entire course of treating the patient. The patient was last seen by the subsequent treating physician on May 25, 1982, at which time he had intraocular pressures of 16 in the right eye and 18 in the left eye without medication. Another visual field test was performed on that date, which again disclosed normal vision. The subsequent treating physician, like Respondent, diagnosed the patient to be a potential "glaucoma suspect." In the Administrative Complaint, Respondent is charged with requiring Mr. Miller to make an excessive and unnecessary number of office visits. The Respondent is also charged with failing to maintain records revealing the frequency of use of the pilocarpine prescribed for Mr. Miller, and further with failing to maintain records indicating the percentage dosage of timolol and the date of beginning of use of that drug. With respect to the latter charge, the record contains no facts to substantiate those allegations and, in fact, contains evidence that Respondent clearly noted in his records the information charged as lacking in the Administrative Complaint. The Administrative Complaint also charges Respondent with having required the patient to visit his office a total of ten times between July 17, 1980, and August 11, 1980, which is alleged to be ". . . an excessive an[sic] unnecessary number of office visits." The record in this cause establishes that the patient visited Respondent's office a total of eight times during that period. As indicated above, the patient had been seen by Respondent over a period of approximately four years before there was ever any indication of even marginally elevated pressures. Given the patient's history of diabetes and hypertension Respondent, in the exercise of his clinical judgment, determined to treat the condition with medication. Although the record in this cause contains credible testimony that some physicians would not have treated the condition at all, or would have seen the patient at most once a week, equally credible evidence contained in this record establishes that once the decision to treat was made and the patient was started on medication, it was entirely proper to monitor the patient closely to determine the effect that the medication was having on the patient's pressures. It should be noted that the Respondent is not charged in the Administrative Complaint with prescribing excessive or unnecessary medication. Based upon the foregoing, it is therefore concluded that there is an insufficient factual basis in the record in this proceeding to establish that, under the conditions present here, the Respondent departed from reasonable medical practice in seeing the' patient on eight occasions during approximately a one-month period. ELEANOR DRAGER This patient was first seen by Respondent on January 7, 1980. At that time the patient gave a history of having had her vision go blurry for 15 to 20 minutes on two occasions since the beginning of the year. An examination of the patient's eyes showed her vision to be 20/29 in her right eye and 20/100 in her left eye. Intraocular pressures were 30 in her right eye and 28 in the left eye, both of which are considered to be quite high. The patient's last eye examination had been in October of 1978. The patient was next seen on January 9, 1980, at which time Respondent determined it necessary to perform cataract surgery and to implant an intraocular lens. The surgery was performed on January 30, 1980, and, in addition to removing a cataract and implanting a lens, Respondent performed a posterior sclerotomy, a procedure performed by making a tiny hole in the eye wall and inserting a needle to aspirate vitreous fluid, thereby allowing the remaining vitreous to resume a normal position. The patient was seen postoperatively on February 1, 1980, and again on February 7, 1900. Respondent's practice is to visit frequently with postoperative patients in order to closely monitor the patient's condition. On the February 7, 1980, examination, the patient's vision was 20/70 in her left eye, which Respondent considered excellent for one week postsurgery. The pressure in the eye was 20 and there were no other changes of note. The patient was next seen on February 13, 1980, at which time her vision was only 20/200 in her left eye. The only other finding of note on this date was that the lens implant had shifted to a position closer to the cornea. The patient was next seen on March 13, 1980, at which time her vision was still 20/290 in the left eye, and her pressures were 22 in the right eye and 44 in the left eye. Respondent improved the patient's vision to 20/60 in her left eye with a lens change in her glasses. The patient was next seen on March 25, 1980, in response to a call from the patient indicating that on the previous day she had experienced foggy vision in her left eye, and within an hour could see nothing at all out of the eye., The patient had treated the problem herself with eye drops and, within a couple of hours, her vision had improved. Upon examination, Respondent discovered the patient's vision to be 20/200 in the left eye, with a pressure of Respondent restored the patient's vision to 20/25 with a glasses change, leading him to suspect, in view of the patient's recent surgery, that there was a possibility of retinal detachment or retinal tear with possible vitreous hemorrhage. Respondent was unable to see the entirety of the back of the Patient's eye in order to determine the presence of a retinal tear because a view of certain portions of the eye was blocked by the intraocular lens implant. The patient was next seen on March 31, 1980, complaining of "haze" over her left eye. The patient's vision has worsened to 20/40 in her left eye, and her intraocular pressures were 26 in both eyes. The Respondent again changed the lenses in the patient's glasses, restoring her vision to 20/25 in the left eye. The patient was next seen on April 14, 1980, still complaining of the "haze" over her left eye and an additional complaint of many black dots in the left eye since her last visit. Respondent dilated the eye, and found a large number of vitreous floaters present. Respondent concluded from the presence of these floaters that the patient had probably suffered a vitreous hemorrhage. The most common reason for floaters to be present in a postsurgical cataract patient with a vitreous hemorrhage is retinal tear. Respondent could not, however, actually see the retinal tear upon visual examination. The patient was seen again on April 16 and on April 18, 1980, complaining of an increase of black soots in her left eye. Upon examination, Respondent noted the presence of vitreous traction in the left eye, and determined that the patient should be scheduled for cryo-pexy surgery to be performed in his office on April 21, 1980. Cryo-pexy surgery is an operation that involves the application of cold, in this case a local drop of opthane, to the eyeball in order to produce a tissue destruction to release adhesions thereby avoiding potential retinal tear or detachment. The procedure can be performed in a physician's office, as opposed to a hospital, and requires only 10 to 15 minutes to perform. At the time cryo-pexy surgery was to be performed, Respondent had been unable to actually observe a retinal tear, although he had noted the presence of retinal traction. Respondent felt, however, that a retinal tear could have been caused by the placement of the needle through the pars plana during the course of performing the posterior sclerotomy on January 30, 1980. In fact, many ophthalmalogists perform cryo- pexy at the same time as a posterior schlerotomy in order to prevent a retinal tear from developing as a result of that procedure. Respondent chose to recommend cryo-pexy surgery for a variety of reasons. Among them were the recent cataract surgery, the implantation of an intraocular lens, the performance of the posterior sclerotomy, and the' patient's history of heart disease which would have made it more complicated to perform cutting surgery as opposed to cryo-pexy should an actual retinal detachment occur. The patient had a history of recent phlebitis which had hospitalized her, so that the possibility of placing her under general anesthesia in order to perform major surgery for a retinal detachment thereby leaving her inactive in a hospital bed for a period of days could have resulted in a complication of her phlebitis. The decision to perform cryo-pexy surgery involved the exercise of clinical judgment. Respondent, by necessity, had to weigh the dangers of performing the surgery against problems that might be associated with failure to perform the procedure. The three principal reasons advanced in this record for not performing this procedure were that Respondent's records indicated only the presence of "floaters" and not an actual vitreous hemorrhage; Respondent could not actually visualize the retinal tear prior to recommending surgery; and, the performance of cryo-pexy could have further traumatized an eye which had already been subjected to considerable surgical manipulation. In response to these considerations, Respondent testified, without contradiction, that he considered the presence of "floaters" to be synonymous with vitreous hemorrhage and, therefore, saw no reason to actually note the presence of hemorrhage in his notes. Further, although Respondent could not actually see a retinal tear in the patient's eye, based on his course of treatment of the patient he was aware of the site through which he had placed the needle in performing the posterior sclerotomy, and reasonably concluded that the performance of that procedure, in the presence of so great a quantity of floaters in the patient's eye, could have resulted in a retinal tear. In short, the patient's symptoms were consistent with development of a vitreous hemorrhage following cataract extraction. In light of the fact that the cataract extraction included the performance of a posterior sclerotomy through the pars plana, there was every reason to believe that the patient might have had a hole somewhere in the region of the sclerotomy site. Under these conditions cryo-pexy is an acceptable means of treating this condition despite being unable to see an actual retinal tear. The risk in delaying the performance of the cryo-pexy was that the retina could detach and the problem thereby become more difficult to manage. In making the decision to perform cryo-pexy, the Respondent weighed the risk of performing the procedure against the risk of not performing it, and reasonably determined that the best course of treatment was to perform the procedure.
The Issue The issues are whether 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, and, if so, what penalty, if any, should be imposed.
Findings Of Fact 1. Stipulated Facts Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.30 and Chapters 455 and 458, Florida Statutes. Respondent is a licensed physician in Florida holding license number ME 0009772. Respondent's last known address is 9430 Turkey Lake Road, Orlando, Florida 32819-8015. Respondent is Board certified in orthopedic surgery. Respondent provided medical treatment to two male patients between 1990 and 1991. Patient 1 was treated from approximately April 29, 1991, through August 12, 1991. At the time, Patient 1 was approximately 34 years old. Patient 2 was treated from approximately May 14, 1990, through June 20, 1991. Patient 2 was approximately 29 years old. Patient 1 Patient 1 had a history of hip dislocation with aseptic necrosis, chronic back and leg pain, and foot numbness associated with degenerative disc disease and lumbar stenosis. Lumbar stenosis is compression of the spine. Spine compression was particularly significant between the fifth lumbar and first sacral vertebrae. Prior to April 29, 1991, Patient 1's treatment was conservative and nonsurgical. On April 29, 1991, Patient 1 presented to Respondent to explore alternative therapy. Patient 1 complained of pain and numbness in his back, hip, and legs. Respondent diagnosed Patient 1 with lumbar spinal stenosis and possible disc herniation. Respondent recommended a myelogram. A myelogram was performed on May 13, 1991. The myelogram confirmed Respondent's diagnosis of lumbar spinal stenosis and possible disc herniation. The myelogram revealed a disc defect on the right side of L5-S1 as well as severe spinal and lateral recess stenosis. On June 11, 1991, Respondent performed a laminectomy on Patient 1, an L5-S1 disc excision, and an internal spinal stabilization using Harrington rods attached with lamina hooks. Use of lamina hooks resulted in the compression of Patient 1's underlying neural tissue. Compression of the underlying neural tissue caused Patient 1 to suffer perineal numbness. Respondent's medical records of June 17, 1991, show that Respondent knew Patient 1's perineal numbness was a result of compression of the sacral nerve root at L5-S1. On June 17, 1991, Respondent again performed surgery on Patient 1. Respondent replaced the lamina hooks with alar hooks. Respondent also replaced and adjusted the tension of the Harrington rods. On August 1, 1991, Patient 1 was admitted to Sandlake/Orlando Regional Medical Center ("ORMC") for surgical removal of the implanted hooks and Harrington rods. Respondent surgically removed the Harrington rods and attachment hooks. On August 12, 1991, Respondent's medical records showed that Patient 1 suffered from persistent numbness of the sacral nerve root areas. The area of numbness included the perineum, scrotum, and penis. Respondent did not perform an L5-S1 bone fusion during any surgery. Patient 2 On May 14, 1990, Patient 2 presented to the Emergency Room ("ER") at ORMC with primary complaints of back and right leg pain. The ER physician diagnosed Patient 2 with a herniated nucleus pulposus at L4-L5. The nucleus pulposus is the soft central portion of the intervertebral disc. Respondent admitted Patient 2 on May 14, 1990, and treated him with intravenous muscle relaxants. On May 15, 1990, a computerized axial tomography ("CAT") scan revealed a bulging, herniating disc at L4-L5. On May 17, 1990, Respondent discharged Patient 2 with instructions regarding back care and an exercise program. On August 24, 1990, Patient 2 presented to Respondent with recurrent disabling sciatic pain. A magnetic resonance imaging ("MRI") scan was performed on August 28, 1990. The MRI revealed a prominent disc bulging at L4-L5 with material intruding into the spinal cord. On September 7, 1990, Respondent performed a lumbar laminectomy and disc excision at L4-L5. Respondent discharged Patient 2 on September 12, 1990. On December 11, 1990, Patient 2 presented to Respondent with recurrent back and right leg pain. Respondent prescribed analgesics including Soma with codeine and Naprosyn. On January 14, 1991, Patient 2 presented to Respondent with back and right leg pain. Patient 2 underwent a CAT scan to determine if recurrent disc herniation was present. The CAT scan failed to indicate any obvious asymmetric changes which would confirm Respondent's diagnosis of recurrent disc herniation. On January 21, 1991, Respondent performed a decompressive laminectomy on Patient 2. Respondent's operative report for January 21, 1991, indicates that Respondent found no evidence of a herniated disc. On February 26, 1991, Patient 2 presented to Respondent with complaints of recurrent leg and back pain. Respondent referred Patient 2 to Dr. William Bradford for treatment utilizing epidural blocks. On April 16, 1991, Patient 2 again presented to Respondent. Respondent placed Patient 2 in a molded, fiberglass body jacket. Back and leg pain subsided while Patient 2 wore the fiberglass jacket. On May 14, 1991, Respondent performed surgical stabilization of the lower lumbar spine utilizing Harrington rods. On June 17, 1991, Patient 2 presented to Respondent with persistent numbness of the perineal area as well as bowel and bladder incontinence. Respondent determined that the numbness and incontinence were caused by sacral nerve root irritation associated with the Harrington rod hooks. Respondent surgically adjusted the Harrington rods on June 20, 1991. Respondent did not perform vertebral bone fusion during any surgery. 2. Standard Of Care Respondent failed to practice medicine in his treatment of Patient 1 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. Respondent improperly seated lamina hooks in Patient 1. As a result, Patient 1 suffered compression of underlying neural tissue. Respondent improperly used Harrington rods and hooks to achieve transient spinal decompression without performing essential vertebral bone fusion. Use of Harrington rods in the lumbar spine is an obsolete technology. It is fraught with dangers. Among other things, it eliminates the lordosis, or natural spinal curvature. Respondent failed to practice medicine in his treatment of Patient 2 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. Respondent performed numerous surgeries on Patient 2 when CAT scans and other examinations failed to confirm recurrent disc herniation. In addition, Respondent failed to perform essential vertebral bone fusion on Patient 2. 3. Proximate Cause And Severity Of Injury Respondent's failure 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 was the proximate cause for permanent neurological damage to Patient's 1 and 2. Both patients suffered sacral nerve root paralysis. Sacral nerve roots feed functions in the pelvis, bladder bowel, and sphincter. Both patients suffered permanent incontinency, including loss of bladder and bowel function. Each patient requires a colostomy and must wear diapers. Patient 1 has suffered sexual dysfunction in that he has lost the sensation necessary for a natural erection. The neurologic injuries to Patients 1 and 2 are major and permanent. Nothing can restore the functional loss suffered by either patient.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Respondent enter a Final Order finding Respondent guilty of violating Section 458.331(1)(t) in his treatment of Patients 1 and 2, imposing an administrative fine of $7,500, and restricting Respondent's practice as follows: Respondent shall not perform any spinal surgery on patients unless and until Respondent appears before the Board of Medicine and demonstrates to the satisfaction of the Board that he is able to do so with skill and safety; and The Board of Medicine may place other reasonable conditions on Respondent's practice of orthopedic surgery at such time as the restriction in the preceding paragraph is lifted. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 6th day of October, 1994. DANIEL MANRY Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 6th day of October, 1994. APPENDIX TO RECOMMENDED ORDER, CASE NO. 93-3966 Petitioner's Proposed Findings of Fact 1. -39. Accepted as stipulated fact 40.-41. Rejected as recited testimony Accepted in substance Rejected as recited testimony Accepted in substance 45.-51. Rejected as recited testimony Respondent's Proposed Findings of Fact Respondent stipulated to Petitioner's proposed findings of fact, paragraphs 1- 39. Respondent's only additional proposed finding of fact is unnumbered and is rejected as not supported by persuasive evidence. COPIES FURNISHED: Dr. Marm Harris, Executive Director Department of Business and Professional Regulation Board of Medicine Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792 Harold D. Lewis, Esquire Agency For Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, FL 32303 Kenneth J. Metzger, Esquire Agency For Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0792 Jack L. Gresham, M. D. 9430 Turkey Lake Road Orlando, Florida 32819-8015
