The Issue Whether AHCA found a deficiency at Cypress Manor sufficient to support the issuance of a Conditional license effective September 4, 1997.
Findings Of Fact Cypress Manor is a nursing home located in Fort Myers, Florida. Every year, Cypress Manor is surveyed by AHCA to determine whether the facility should receive a Superior, Standard or Conditional licensure rating. On September 4, 1997, AHCA conducted its annual survey of Cypress Manor. After the survey was completed, AHCA alleged that the facility was not in compliance with 42 CFR Section 483.25(c), the regulatory standard dealing with the prevention and treatment of pressure sores on residents.1 AHCA issued a survey report in which this deficiency was identified and described by a “Tag” numbered F314. AHCA is required to rate the severity of any deficiency identified during a survey with two types of ratings: “scope and severity” rating defined by federal law, and a Class rating which is defined by State law. After the September survey, AHCA assigned the F314 deficiency a scope and severity rating of “G” which, under federal regulations, is a determination that the deficient practice was isolated.2 The F314 deficiency was also given a State Classification rating of II which, under state law and Agency rule, is a determination that the deficiency presented an imminent threat to the health, safety or security of the residents. Because AHCA determined that there was a Class II deficiency at Cypress Manor after the September survey report, it changed Cypress Manor’s Standard licensure rating to Conditional effective September 4, 1997. By law, Cypress Manor was required to post the Conditional license it received in a conspicuous place near the entrance to the facility. See also, Section 400.23(8)(g), Florida Statutes. AHCA also placed Cypress Manor’s name on a list of facilities that received Conditional licenses which was distributed to and published by newspapers throughout Florida. These acts adversely affected Cypress Manor. After AHCA issued its September survey report, Cypress Manor was required to submit a Plan of Correction to AHCA. Although the plan submitted did not admit the allegations of the survey, it did provide a plan of corrective action that the facility would implement to address the deficiencies cited in the survey. The Plan also represented that all corrective action would be completed by October 1, 1997. AHCA returned to Cypress Manor on October 22, 1997, to determine if the facility had corrected the F314 deficiency alleged in the September survey report. After completing that survey, AHCA determined that the alleged deficiency had been corrected and issued Cypress Manor a Standard license effective October 22, 1997.3 Cypress Manor filed a Petition for Formal Administrative Hearing with AHCA to challenge the findings of the September survey, as well as AHCA’s decision to issue Cypress Manor a Conditional license. That Petition was referred to the Division of Administrative Hearings and a hearing was conducted by Judge Pfeiffer on November 16, 1998. PRESSURE SORES AHCA alleged under Tag F314 of the September survey report that Cypress Manor failed to provide necessary care to one resident to prevent the development of her pressure sores, and failed to provide necessary treatments to that same resident and one other resident to promote healing of their pressure sores. A pressure sore is a loss of skin integrity, usually over a bony prominence, that is caused by unrelieved, prolonged pressure. Since pressure sores are created by pressure, removal of pressure from a resident’s skin is a primary focus of any care plan for a resident to prevent or treat pressure sores. Although it is impossible to determine with any degree of reliability the length of time that a resident can remain in one position before a pressure sore will develop or worsen, the accepted standard of preventative care for or treatment of pressure sores is that a resident should be turned and repositioned every two hours. Additionally, devices such as heel protectors, boots, or seat cushions can be used to help relieve pressure to those parts of a resident’s body on which pressure sores have developed. The risk of development or worsening of pressure sores may be exacerbated by factors other than pressure. A resident who is incontinent produces moisture that can increase the risk of pressure sore development. A diet which does not provide a resident with sufficient calories or protein may hinder the healing process. A routine preventative care plan to address the development or worsening of pressure sores should include interventions to keep a resident dry, nourished and hydrated, as well as relieve pressure to the resident’s body. Interpretative guidelines provided to AHCA’s surveyors in the State Operations Manual (“SOM”) suggest that, before the surveyors determine that a pressure sore that developed on a resident was avoidable, they must determine that the facility did not “consistently” administer routine preventative care. An isolated occurrence of a failure by a facility to administer appropriate preventative care will not preclude a finding that the development of a sore was unavoidable. Moreover, the failure to implement a routine care plan out of deference to a resident’s personal choices or lifestyle, or as a trade-off to meet other needs of the resident is appropriate to consider. Pressure sores can develop or worsen despite the consistent implementation of a routine pressure sore care plan due to a resident’s clinical conditions. A resident may have diseases which affect a resident’s ability to get oxygen to cells, to digest and process food, to have sensory feelings in arms or legs, or rid the body of waste that may make the development or worsening of pressure sores inevitable. A resident may have psychological conditions that make the resident unwilling to accept needed care. A resident does not have to be in a terminal state in order for these conditions to lead to the development of an avoidable pressure sore. When pressure sores appear on a resident, a nursing home will describe them in the resident’s medical record by one of four stages. A stage I area is one in which the skin is unbroken but has nonblanchable redness. A stage II area is a very shallow wound that may present itself as a blister or a small crater. A stage III wound is a deeper wound that penetrates subcutaneous tissue, while a stage IV wound is one which reaches muscles, tendons or bone. Staging a pressure sore is not an exact science. For example, a stage III pressure sore will frequently first appear on a resident as a small red area with no unbroken skin, and will not manifest its true character until the skin later breaks open as part of its natural healing process. Because stage III wounds can present themselves in that manner, it is not uncommon for a caregiver to initially document that the sore is a stage I or II sore. In those instances, the true initial character of a pressure sore can only be determined in hindsight or by looking at information other than the stages assigned to the sore, such as pictures, measurements and descriptions of the sore from the resident’s medical record. RESIDENT 4 Resident 4 was one of the two residents identified in the survey report as having received poor pressure sore care. She was admitted to Cypress Manor on February 19, 1997, with many conditions that compromised her body’s ability to prevent the development of pressure sores, including pneumonia, dehydration, cardiac arrhythmia, hypertension, dementia with psychotic agitation (that manifested itself through an unwillingness to cooperate with care or to get out of her wheelchair for prolonged periods of time) and a previous heart attack. Resident 4 was admitted to Cypress Manor with a stage I pressure sore on her left heel. Between her admission on February 19, 1997, and February 24, 1997, Resident 4’s left heel pressure sore was charted as moving from a stage I to a stage II sore and, by March 27, it was shown as a stage III sore. In early April, Resident 4 broke her hip and had to go to the hospital. While in the hospital, her left heel pressure sore became larger and she developed a stage III pressure sore on her right heel. Resident 4 returned to the facility and developed a stage II pressure sore on both her left and right buttocks on May 12, and a stage II pressure sore on the bottom of her left foot on August 31. Of the five pressure sores that developed on Resident 4 between February and September, the right and left buttocks’ sores and the sore on the bottom of her left foot developed while Resident 4 was at Cypress Manor. Each sore developed despite a comprehensive care plan for Resident 4 to prevent the development of sores that included turning and repositioning Resident 4 at least every two hours, incontinence care, heel protectors, a pressure relieving mattress, a top-of-the-line Roho gel cushion in her wheelchair and monthly dietary assessments. AHCA’s expert on pressure sores, Dr. Joel Mattison, conceded that the care plans that Cypress Manor developed to prevent pressure sores on Resident 4 were good. Cypress Manor’s expert on pressure sores, Theresa Vogelpohl, opined that the pressure sores developed by Resident 4 on her buttocks were unavoidable due to her clinical conditions. Resident 4 had pneumonia which prevented the facility from increasing Resident 4’s hydration, because increasing fluids would increase the risk that the pneumonia might worsen. She had an infection in her left heel which compromised her body’s resistance to pressure sore development. She had a fractured hip that increased her risk for blood clots and therefore increased her need to be up in a wheelchair. She had severe circulatory impairment and dementia and was resistive to care. Because the facility had a comprehensive care plan to address pressure sore development (that included a top-of-the-line gel cushion), Ms. Vogelpohl determined that Resident 4’s clinical conditions caused the development of her buttocks’ sores. Ms. Vogelpohl opined that the pressure sore that developed on the bottom of Resident 4’s left foot was also unavoidable. The facility put a Mediboot on Resident 4’s left foot in March to relieve pressure to the pressure sore that existed on Resident 4’s left heel. However, use of the Mediboot increased the Resident’s risk for development of pressure sores on the bottom of her foot, particularly when the Resident used her foot to propel herself in her wheelchair. Because the facility believed that the risk of harm to her left heel without the Mediboot was greater than the risk of development of a sore on the bottom of her foot with it on, the facility kept the Mediboot in place. The correctness of this decision was confirmed as the Resident’s left heel improved and she did not develop any pressure sores on her left foot until August 31, some five months after the Mediboot was placed on her. Thus, the ultimate development of the sore on the bottom of her foot was an unavoidable consequence of other needed care for the Resident. AHCA did not claim that all five of Resident 4’s pressure sores were avoidable, but instead stated that Cypress Manor could have prevented the development of the pressure sores on the Resident’s right and left buttocks.4 Additionally, AHCA did not allege that the development of those sores was related to the failure to assess Resident 4 and develop adequate care plan interventions to prevent the development of the sores. Rather, AHCA believed they developed solely because Cypress Manor failed to implement one component of its care plan program effectively. Dr. Mattison opined that Resident 4 developed preventable pressure sores on her buttocks in May because the facility left the Resident in her wheelchair for too long. He inferred that Resident 4 had been left in her wheelchair too long in May because the survey report stated that the surveyors observed the Resident in her wheelchair for extended periods of time during the September survey.5 However, no surveyor testified at hearing that these observations were made, and Dr. Mattison did not talk to the surveyors about their observations, did not personally observe the Resident and did not offer anything from the Resident’s medical record during that time period to support this conclusion. In addition to showing that Resident 4’s three in-house acquired pressure sores were unavoidable, Cypress Manor showed that it had a good treatment program for Resident 4’s pressure sores, and that all five of Resident 4’s pressure sores steadily improved after they developed. Resident 4’s right heel sore and her right buttock sore were completely healed by August 4 and August 15, 1997, respectively. The sore on the bottom of her left foot was completely healed within 30 days of its development. The left heal pressure sore progressed steadily and was nearly closed by the time of the September survey, and the left buttock pressure sore had been substantially reduced in size by the time of the September survey. Despite this record which showed improvement of Resident 4’s pressure sores, AHCA claimed that Cypress Manor did not provide all necessary treatments to promote healing of the wounds. The specific allegations made by AHCA were that Cypress Manor (a) failed to implement its pressure sore care plans for all of its residents, (b) left Resident 4 up too long in her wheelchair during the survey, (c) failed to update Resident 4’s pressure sore care plan and provide any new interventions after the left heel pressure sore became a stage III sore on March 27, (d) failed to provide all required dressing changes to Resident 4’s left heel between February 19 and March 27, 1997, and (e) failed to provide adequate dietary interventions to Resident 4 to promote healing of all of the pressure sores. AHCA did not present evidence to support the allegations described in (a), (b) or (c) above. AHCA also admitted that the treatments given to the pressure sores on Resident 4’s buttocks and the bottom of her left foot were good. Although AHCA failed to present any evidence in support of its claim that the facility should have updated Resident 4’s care plan on March 27, 1997, Cypress Manor disproved the allegation. AHCA’s belief that the plan should have been updated was predicated on the assumption that the sore had worsened from a stage I to a stage III sore. In fact, it had not. Although Resident 4’s medical records described the sore as a stage I sore that progressed to a stage III sore, they also initially described the sore as an area of red skin surrounding a blue area. The description of a blue area indicated that the sore had deep tissue damage associated with a stage III sore, which was confirmed when the sore later opened up and revealed that damage in March. Moreover, Resident 4’s medical records reflected that the sore had decreased in size between her admission and March 27, thereby indicating that the care plan the facility designed for the sore was appropriate. Finally, Cypress Manor demonstrated that the facility had implemented new interventions around March 20 (Mediboots and new treatments). Dr. Mattison was the only AHCA witness to testify with regard to AHCA’s claim that Cypress Manor failed to provide all dressing changes to Resident 4’s left heel between February 19 and March 27.6 He inferred that the facility failed to treat the wound between February 19 and March 27 because the facility failed to treat the wound once in April. However, he acknowledged that this belief was not supported by Resident 4’s February and March treatment records, and that his opinion was based upon a “paranoia” about care rather than facts. Cypress Manor presented Resident 4’s February and March treatment records which showed that Dr. Mattison opinion was incorrect, and that all needed treatments were provided to Resident 4. AHCA’s specific allegations regarding the absence of appropriate dietary care for Resident 4 were that, between May and September 1, 1997, Cypress Manor (a) waited until July 1 to implement a dietician’s May 23 recommendation for vitamin therapy for the Resident, (b) failed to provide Resident 4 with ordered supplements several times in August and twice during the September survey, and (c) failed to communicate the dietician’s recommendation for procalamine treatments for the Resident to the Resident’s doctor.7 AHCA’s surveyor also testified that Resident 4’s lab values taken in late July confirmed that Cypress Manor was not providing adequate dietary interventions to Resident 4 because they indicated she was suffering from severe protein malnutrition. Cypress Manor provided Resident 4 with a diet that was adequate to promote healing of her pressure sores. Dieticians in a facility can estimate the caloric and protein needs of a resident by using formulas such as the Harris Benedict Equation or the Agency Health Care Policy and Research (“AHCPR”) Guidelines for pressure ulcer healing. Those formulas are estimates of a resident’s nutritional needs based upon a resident’s height and weight, and provide for adjustments based upon factors such as resident obesity or stress caused by injury. Cypress Manor’s dietician assessed Resident 4’s nutritional needs when she was admitted to the facility, defined her as being at nutritional risk, and implemented aggressive dietary interventions to meet those needs. Based upon AHCPR guidelines, Resident 4 needed 1600-1900 calories per day and 64-83 grams of protein to meet her nutritional needs and promote healing of her pressure sores. Resident 4 was given a no-added-salt diet, fortified foods, whole milk, extra fruit juices and ice cream that provided her with over 4100 calories and 135 grams of protein per day, as well as twelve times the recommended daily allowance of Vitamin C. Resident 4’s consumption records demonstrated that she consumed enough of her diet to meet her assessed needs every month between April and August 1997. In addition to showing that it provided Resident 4 with an adequate diet to promote healing of her pressure sores, Cypress Manor also demonstrated that its dietician was assessing Resident 4’s nutritional status at least monthly, which was three times as frequent as regulations require. All of these interventions were imminently successful as Resident 4’s pressure sores on her right side healed while those on her left side steadily progressed toward healing between April and September of 1997. Additionally, the facility was able to maintain another important indicator of good nutritional status -- the Resident’s usual body weight -- within its normal ranges during this same time period. AHCA’s contention that Cypress Manor failed to implement a May recommendation by its dietician to add vitamin therapy to the Resident’s dietary regimen until July 1, did not establish that the facility failed to provide Resident 4 with adequate nutrition to promote healing of pressure sores. A primary benefit of vitamin therapy to a resident with pressure sores is that it provides Vitamin C to the resident. The surveyor apparently noted that, because the dietician recommended the Vitamin C, Resident 4 was not getting enough Vitamin C to promote healing. However, Resident 4 was already receiving twelve times her recommended amount of Vitamin C when the May recommendation for a multivitamin was made, and continued receiving that amount up to and after the facility began giving Resident 4 a multivitamin. The failure to provide Resident 4 with the multivitamin did not deprive her of any meaningful amount of Vitamin C and did not retard the healing process for Resident 4’s pressure sores. In fact, all four of the pressure sores that Resident 4 had on May 23 decreased in size by July 1. Likewise, AHCA’s contention that the facility failed to provide Resident 4 with Promod shakes several times in August and twice during the September survey did not establish that the facility failed to provide Resident 4 with adequate nutrition to promote healing of pressure sores. The surveyor apparently believed that, because the dietician ordered the supplements, the Resident was not receiving enough protein and calories from her existing diet. However, at the time the surveyors claim that Resident 4 was not receiving these supplements, Resident 4 was consuming 700-1300 more calories and 17-36 more grams of protein than she needed to promote healing of her pressure sores. Cypress Manor showed that the failure to provide Resident 4 with the supplements did not deprive her of any meaningful amount of protein or calories and did not retard the healing process for Resident 4’s pressure sores. AHCA’s contention that the facility failed to follow through with the dietician’s recommendation for procalamine treatments was based solely upon the fact that nothing was written in the Resident’s medical record to show that the facility contacted the doctor about the recommendation. In fact, the facility had contacted the Resident’s doctor and he rejected the recommendation. The facility informed the surveyors of this rejection and documented it in the Resident’s record at the time of the survey. Any delay in documenting the doctor’s rejection of the recommendation did not cause any harm to Resident 4 or deprive her of any needed dietary interventions. AHCA’s surveyor claimed that her opinion that the facility failed to adequately nourish Resident 4 was absolutely confirmed by lab values that were taken for Resident 4 at the end of July of 1997. The Resident’s albumin, pre-albumin, transferring and BUN levels were all lower than normal range and AHCA’s surveyor interpreted them to mean that the Resident was suffering from severe protein malnutrition. While lab values can be an indicator of the nutritional status of a resident, AHCA’s surveyor and the SOM guidelines acknowledge that it is not always appropriate to the use low values as proof that a resident is malnourished. Low lab values may indicate that a resident is ill rather than malnourished. Some residents will have low lab values regardless of the adequacy of their diets. Lab values cannot be considered the single indicator of a resident’s nutritional status, but must be interpreted in the context of the overall clinical picture of the resident. During the seven-month period chosen by the surveyors in which to evaluate Resident 4, she presented numerous compromising conditions. She had pneumonia, a broken hip, five pressure sores, and had received multiple rounds of antibiotic therapy. Additionally, she suffered from dementia, a condition that can affect a person’s metabolism. Low lab values are not unusual for a resident with these types of conditions. In light of the fact that Cypress Manor provided Resident 4 with an adequate diet to meet her nutritional needs, Resident 4’s low lab values were indicative of her compromised condition rather than a malnourished state. RESIDENT 8 Resident 8 was the only other resident who was identified in the survey report under Tag F314 and AHCA alleged that Cypress Manor failed to provide him necessary treatments to prevent worsening of his pressure sores. Resident 8 was admitted to Cypress Manor in August of 1997 with stage I pressure sores on both of his heels. He had a pressure sore care plan that included turning and repositioning, a pressure relieving mattress, incontinence care, heel protectors while in bed and treatments daily to his sores by the wound nurse. In addition to having pressure sores, Resident 8 was at risk for falls when he would attempt to walk on his own. Resident 8 was also dying from pancreatic cancer, and all of his care plans were tempered by the order that his comfort was the primary objective of any care offered to him. During one day of the survey, AHCA’s surveyor, Bill Sullivan, observed Resident 8 lying in bed with his shoes on without heel protectors on either heel. Because Resident 8’s care plan directed that he was to have heel protectors on while in bed, Mr. Sullivan cited the facility under Tag F314 for failing to provide necessary treatment to promote healing of Resident 8’s pressure sores. However, he acknowledged that neither of Resident 8’s pressure sores worsened while Resident 8 was at the facility. Dr. Mattison, AHCA’s expert on pressure sore care, contradicted Mr. Sullivan’s Tag F314 conclusions. Dr. Mattison testified that a single instance of a facility’s failure to follow a care plan did not violate the standards of the regulation. He further testified that Resident 8’s pressure sores were not going to heal because of the Resident’s terminal state, and that the Resident’s choices and comfort were a primary concern. For those reasons, Dr. Mattison testified that he did not believe that the facility failed to provide necessary care to Resident 8.8 Cypress Manor also demonstrated that there were valid reasons not to remove Resident 8’s shoes and put heel protectors on him every time he went to bed. Resident 8 frequently put himself to bed and got up on his own. The heel protectors that were ordered for Resident 8 were slick and increased his risk for falling if he attempted to walk in them. Accordingly, the facility did not put them on him during his day naps because of the risk that he might get up on his own and attempt to walk in them.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is recommended that the Agency for Health Care Administration enter a final order issuing a Standard rating to Cypress Manor and rescinding the Conditional rating. DONE AND ENTERED this 10th day of February, 1999, in Tallahassee, Leon County, Florida. WILLIAM R. PFEIFFER 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 10th day of February, 1999.
Findings Of Fact John D. Elder is a site worker at Port St. Lucie High School, having first been employed by the St. Lucie County School Board as a temporary employee in the summer of 1993. When first employed, Mr. Elder rejected the option to enroll in the employer's insurance plan. In September 1993, Mr. Elder was given an employer's insurance form allowing ninety days for enrollment. On November 12, 1993, he completed the form and became eligible for certain benefits on January 1, 1994. The St. Lucie County School Board Medical Benefit Plans, in which Mr. Elder enrolled, excludes coverge for pre-existing conditions until the end of 12 months of continuous coverage. The plans include the following definitions: A pre-existing condition is an injury, sickness or pregnancy or any condition related to that injury, sickness or pregnancy, where a diagnosis, treatment, medical advice or expense was incurred within twelve (12) months prior to the effective date of this coverage. Pre-existing condition will also include any injury, sickness or pregnancy or related condition that manifested itself twelve (12) months prior to the effective date of this coverage. Pre-existing condition will also include the existence of symptoms which would cause an ordinarily prudent person to seek diagnosis, care or treatment within twelve (12) months prior to the effective date of this coverage. (Emphasis Added.) From 1985 to 1988, Mr. Elder was treated by Dr. Urban who, on March 24, 1988, performed an electrocardiogram ("EKG"), which was normal. Dr. Urban treated Mr. Elder for respiratory illnesses, such as bronchitis and pleurisy, for back and shoulder muscle spasms, bursitis/tendonitis, and for high blood pressure. On September 21, 1988, Mr. Elder first saw Dr. Richard Dube. On that day, his heart rate was 62, as compared to the normal range of 60 to 100. In October 1988, Dr. Dube treated Mr. Elder for an inflammation of the muscle behind his shoulder. In December 1988 and January 1989, he treated Mr. Elder for high blood pressure and headaches. In July 1991, Mr. Elder called an ambulance and was taken to the hospital complaining of pain in his neck, across his shoulders, and down his arms. Among other tests, an EKG was performed. The diagnosis was tendonitis in his right shoulder. Later that same year, Mr. Elder complained of heart burn. Dr. Dube treated him for epigastric distress and high blood pressure. Blood test analyses of his cholesterol and high, low and very low density lipid levels indicated a cardiac risk factor of 10.3 for Mr. Elder, which is more than twice the standard male risk factor of 5.0. Dr. Dube ordered blood tests again in January 1993, at which time Mr. Elder's cholesterol and high density lipid levels were still high, but had decreased, reducing the cardiac risk factor to 8.0. Dr. Dube also referred Mr. Elder for an ultrasound of the gallbladder, which was diagnosed on January 29, 1993, as having calcification, which could represent a gallstone, and probably having a small polyp. At the same time he treated Mr. Elder for carpal tunnel syndrome and temporomandibular joint syndrome ("TMJ"). Most recently, on July 27, 1993, the same tests were repeated. With cholesterol in the normal range, the cardiac risk factor was decreased to 6.5. In the fall of 1993, Mr. Elder's complaints were diagnosed as episgastric reflux. To reassure Mr. Elder, Dr. Dube ordered another EKG, which was performed on November 23, 1993, and was normal. On January 3, 1994, Mr. Elder's complaints of ongoing pain caused Dr. Dube, who suspected he had a hiatal hernia, to refer him to Dr. Dan G. Jacobson for an upper endoscopy. Dr. Jacobson recorded a history of episgastric/chest pain, hypertension, ulcers and arthritis. Dr. Jacobson also noted a family history described as "remarkable for heart problems, heart attack." The admitting diagnosis was "history of episgastric pain refractory to medical therapy." Dr. Jacobson performed the endoscopy and diagnosed mild stomach gastritis. Based on a two week history of epigastric and chest pain, and his conclusion that the pain was too severe to result from the endoscopy findings, Dr. Jacobson consulted a cardiologist. Dr. Robert N. Blews, a cardiologist, saw Mr. Elder in the hospital. The history taken by Dr. Blews noted (1) that Mr. Elder's father died of a heart attack at age 68, and that his mother had coronary bypass surgery at age 48 and died at age 59, (2) that the onset of "chest tightness" was approximately one year prior, and (3) that he has a history of cervical spine disease. Dr. Blews' notes also reflected a change in the pattern of the chest pains in the last one to two months, and additional changes in the last two weeks. The longest episodes of pain were lasting from 20 to 30 minutes, with associated sweating and shortness of breath. Mr. Elder also told Dr. Blews that the pain could be with exercise, at rest, could awaken him, and occurred while he was just walking to his car. The report describes Mr. Elder as having a history of smoking. The EKG which Dr. Blews ordered on January 8, 1994 showed a major blockage on the left side of the heart, and is significantly different from all of the prior EKGs, including that taken on November 23, 1993. Dr. Blews concluded that Mr. Elder was having angina, or a decrease in the blood supply to his heart two weeks, two months, and a year before January 1994. Mr. Elder's wife, Florinda Elder, has been aware of his complaints of stomach problems for 10 years, but had no knowledge of his heart problems until January 1994. She was not aware of his having ever smoked or complained of shortness of breath. Although she was at the hospital, Mrs. Elder was not in the room when Dr. Blews took her husband's medical history. Mr. Elder's shoulder and muscle aches, and cervical spine pain are the result of a serious car accident in 1969. The pains are aggravated by cold weather. Mr. Elder claims to have been under the effects of anesthesia at the time Dr. Blews took his medical history, and denies having had a year of chest tightness, shortness of breath, or difficulty walking to his car. He has not smoked for 20-25 years, which is not inconsistent with Dr. Blews' report of a "history of smoking." Mr. Elder's attempt to undermine Dr. Blews history is specifically rejected. The McCreary Corporation is the administrator of the St. Lucie County School Board's self-insurance plan, which contracts with a consultant, Independent Health Watch. Kay Trentor, R.N., reviewed the claims submitted by Mr. Elder, and concluded that his coronary artery disease was a pre-existing condition. In part, Ms. Trentor was relying on Dr. Blews history of a year of "chest tightness." Mr. Elder's records were also sent for peer review, to two other consultant organizations, Professional Peer Review, Inc. and Medical Review Institute of America, Inc. They, in turn, sent the records to Board certified cardiologists, with cardiovascular disease subspecialties. The first report concludes that Mr. Elder "should have known that he had coronary disease because he had multiple risk factors for heart disease," and that "if he was reasonably prudent he would have had this taken care of during the time he was having chest pain walking to the car." The second peer review report also notes a year of chest tightness, with symptoms worsened "over the two months preceding the admission, but . . . not recognized as cardiac until the hospitalization on January 7, 1994." The report concludes that coronary artery disease was not diagnosed until after the effective date. The second report was prepared by Ronald Jenkins, M.D., who believes that Drs. Dube and Jacobson, "seemed to be focusing on gastrointestinal diagnoses . . . and had kind of missed the boat, so to speak . . .," but that "an ordinarily prudent person with John Elder's symptoms which he reported prior to January 1, 1994, [would] have sought medical treatment for those symptoms." Coronary artery disease takes years to develop, but is erratic in manifesting itself, with some people having no symptoms to severe symptoms over a matter of hours. Dr. Dube described it as "silent" coronary disease. Dr. Blews estimates that a heart attack is the first symptom in 40 percent of patients. There is no dispute that Mr. Elder has had other medical conditions, including TMJ, arthritis, and gastroenterological problems. Dr. Jenkins believes the most important manifestation of coronary artery disease was upper precordial chest tightness going to the left upper extremity as well as to the throat. When the history indicates that the tightness occurs with exercise, according to Dr. Jenkins that gives 90 percent confidence that it is anginal chest pain. That confidence level increases to 95 percent when he notes that Mr. Elder told Dr. Blews that chest discomfort occurs when he walks to his car. Without that history, however, Dr. Jenkins would not be able to conclude that the chest discomfort is due to heart disease or that the cardiac condition manifested itself prior to January 1, 1994. Dr. Jenkins described chest heaviness, aggravated by being in cold weather, as a symptom of coronary disease. The same pain without multiple risk factors, occuring irregularly, is a reason for "looking into other alternative diagnoses." Dr. Jenkins also acknowledges that episgastric reflux can cause chest discomfort and throat pain, and that cervical spine degenerative disc disease can cause a radiation of symptoms into the upper extremities, as it did when Mr. Elder called an ambulance in 1991. Dr. Blews did not have trouble getting a complete, detailed history from Mr. Elder. He typically has to elicit a more specific description from patients complaining of chest discomfort. He gives choices such as pain, burn, stab, jab, tight, squeeze or pressure, from which Mr. Elder chose "tight." Dr. Blews also found that Mr. Elder had chest wall pain in several spots or fibrosistitis, which is not a symptom of heart disease. Chest tightness could also be attributable to asthma, according to Dr. Blews, but with radiating pain into the left arm, jaw, and throat, shortness of breath, and sweating, he was certain Mr. Elder had heart disease. All of the doctors agree that Mr. Elder's heart disease existed before January 1, 1994, and that he had no diagnosis, treatment, medical advise or expense related to heart disease in the 12 months prior to January 7, 1994. There is no evidence that he was ever evasive or uncooperative with doctors. On the contrary, Mr. Elder was consistently described in doctor's notes and hospital records as anxious or concerned about his health. Coronary artery disease had not manifested itself to Mr. Elder or his doctors prior to Dr. Jacobson's decision to consult with Dr. Blews. "Manifest" is defined in Respondent's exhibit 9, a page from the International Classification of Diseases, 9th Revision, 1995, or ICD-9, as "characteristic signs or symptoms of an illness." The doctors who testified, in person or by deposition, described every sign or symptom experienced prior to Dr. Blews' consultation, as also being a sign or symptom of Mr. Elder's other medical conditions. Mr. Elder's symptoms might have been diagnosed as also indicating that he had heart disease, if he had been referred to a cardiologist sooner. There is no factual basis to conclude that Mr. Elder, or any ordinarily prudent person, should have sought diagnosis, care, or treatment for heart disease when, in fact, his doctor reassured him that his EKG was normal.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Respondent enter a Final Order approving Petitioner's claim for payment of medical expenses in the amount stipulated by the parties. DONE AND ENTERED this 12th day of July, 1995, in Tallahassee, Leon County, Florida. ELEANOR M. HUNTER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 12th day of July, 1995. APPENDIX TO RECOMMENDED ORDER, CASE NO. 95-0373 To comply with the requirements of Section 120.59(2), Florida Statutes (1993), the following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact. Accepted in preliminary statement and Findings of Fact 2. Accepted in Findings of Fact 3. Subordinate to Findings of Fact 3. Accepted in Findings of Fact 22. Accepted in Findings of Fact 5-8. Accepted in Findings of Fact 5-8 and 12. Accepted in Findings of Fact 7 and 10. Accepted in Conclusions of Law. Accepted in or subordinate to Findings of Fact 6. Respondent's Proposed Findings of Fact. 1. Accepted in Findings of Fact 1 and 2. 2-3. Accepted in Findings of Fact 2. 4-5. Accepted in Findings of Fact 3. Accepted as corrected in Findings of Fact 23. Accepted in Findings of Fact 9. Accepted in Findings of Fact 8 and 9. 9-12. Accepted in or subordinate to Findings of Fact 9. 13-15. Accepted in Findings of Fact 20. Accepted in Findings of Fact 22. Accepted in or subordinate to Findings of Fact 20. Accepted in or subordinate to Findings of Fact 15-23. Accepted in preliminary statement and Findings of Fact 13. Accepted in or subordinate to Findings of Fact 14-16. Accepted in Findings of Fact 14 and 15. Accepted in Findings of Fact 16. Accepted in Findings of Fact 8. Accepted in Findings of Fact 9 and 20. Accepted in Findings of Fact 23. Accepted in Findings of Fact 17. Accepted in Findings of Fact 23. Accepted, but Dr. Dube's testimony was found credible and corroborated by his notes. COPIES FURNISHED: John T. Kennedy, Esquire The Injury Law Offices of John T. Kennedy 309 East Osceola Street Suite 306 Stuart, Florida 34994 C. Deborah Bain, Esquire Wicker, Smith, Tutan, O'Hara, McCoy, Graham & Lane, P.A. 1645 Palm Beach Lakes Boulevard Suite 700 Post Office Box 2508 West Palm Beach, Florida 33401 Frank T. Brogan Commissioner of Education The Capitol Tallahassee, Florida 32399-0400 Dr. David Mosme, Superintendent St. Lucie County School Board 2909 Delaware Avenue Ft. Pierce, Florida 34947-7299
The Issue 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
Findings Of Fact The Respondent, Glenn R. Johnston, is a medical doctor, holding license number ME0018091. His address is 201 North Lakemont Avenue, Winter Park, Florida 32759. The Respondent obtained his Bachelor of Science degree from the University of Florida in 1966, and his medical degree from Bowman Gray School of Medicine in 1970. He served his internship and a two-year general family practice residency at Jacksonville Naval Hospital while serving in the Navy, and became board certified in family practice in 1973. Subsequently, the Respondent served for four years as Chief of the Family Practice Department at the Naval Regional Medical Center in Orlando. In approximately 1976 the Respondent entered private practice in Orlando with a group of doctors, and began his own medical practice in 1977. The Respondent has been married for sixteen years, and has two children, ages 11 and 13. The Respondent performs his family practice in a responsible manner, utilizing the prescription of narcotics and narcotic pain medications at an overall very low rate. The Respondent has never before been the subject of an investigation by the Department of Professional Regulation, and this is the first proceeding against him and his medical license. Between the dates of approximately July 1, 1980, and June 30, 1981, the Respondent prescribed Dilaudid (4 mg.) hydromorphone hydrdchloride for his patient, Robert Hicks in the quantity of 4499. Between the dates of July 3, 1980, and July 3, 1981, the Respondent prescribed Dilaudid (4 mg.) hydromorphone hydrochloride for his patient, James Everett, in the quantity of 4320. Between the dates of approximately July 3, 1980, and June 10, 1981, the Respondent prescribed Dilaudid (4 mg.) hydromorphone hydrochloride for his patient, Harold Stacy, in the quantity of 2550. Between the dates of approximately October 2, 1980, and November 20, 1981, the Respondent prescribed Dilaudid (4 mg.) hydromorphone hydrochloride, Percodan, and Tylox to his patient, Billy Carr, in the quantities of 1620, 30 and 30, respectively. Dilaudid, Percodan, and Tylox are Schedule II controlled substances pursuant to Chapter 593, Florida Statutes. The Physicians Desk Reference (PDR) states the following relative to Dilaudid: Description: DILAUDID (hydromorphone hydrochloride) (WARNING: May be habit forming), a hydrogenated keton of morphine, is a narcotic analgesic . . . * * * DRUG ABUSE AND DEPENDENCE: DILAUDID is a Schedule II narcotic. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of narcotics; therefore, DILAUDID should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when DILAUDID is used for a short time for the treatment of pain. Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued narcotic use, although some mild degree of physical dependency may develop after a few days of narcotic therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients. * * * Oral: The usual oral dose is 2mg. every 4 to 6 hours as necessary. The dose must be individually adjusted according to severity of pain, patient response and patient size. More severe pain may require 4mg. or more every 4 to 6 hours. If the pain increases in severity, analgesia is not adequate or tolerance occurs, a gradual increase in dosage may be required. If pain is exceedingly severe, or if prompt response is desired, parenteral DILAUDID should be used initially in adequate amounts to control the pain. The Respondent prescribed Dilaudid to patient Robert Hicks for severe chronic pain associated with multiple medical problems, primarily related to his severe degenerative rheumatoid arthritis. Mr. Hicks, 49 years of age, had a long history of multiple joint pains, degeneration of his normal joints, chronic pain in his joints, swelling and abnormal laboratory tests. He had been diagnosed as having rheumatoid arthritis since 1976 by a neurosurgeon, confirmed by blood tests and x-rays. He was classified as 100 percent disabled in 1977 by the Veterans Administration because of the chronic joint pains of rheumatoid arthritis. He had been seen by numerous doctors and treated with various pain medications including Dilaudid, which was the only drug that allowed him to function. The pains, discomfort and disability that Mr. Hicks suffered were located in most of the joints of his body, especially in his lumbosacral spine, with involvement in the left hip, shoulder areas, both knees and elbows, with swelling and deformity in the hands. Practically every joint in his body was involved. Mr. Hicks frequently used a cane for walking, and occasionally used crutches. He had difficulty in standing from a sitting position and on occasion he used a wheelchair. The Respondent tried several different medications to treat his rheumatoid arthritis, in addition to physical therapy, and used various pain medications, but Dilaudid proved to be the best when used in conjunction with treatment medications that would allow Mr. Hicks sufficient relief to work and function in a reasonably normal life-style. The Respondent prescribed 4 mg. Dilaudid tablets to Mr. Hicks, to be taken in doses within the limits recommended by the Physician's Desk Reference (PDR) in that the overall quantity prescribed for him did not exceed the maximum limit recommended by the PDR. Mr. Hicks also had other medical problems appropriately treated by the Respondent, such as subdeltoid bursitis, lateral ankylosing spondylitis, spondylolisthesis, Reiter's Syndrome, cervical spondylosis and diabetes. The Respondent prescribed Dilaudid in quantities of two pills of 4 mgs. every four hours as needed for pain, to patient James Everett for chronic severe pain stemming primarily from the lower chest wall and left upper abdominal chest wall which followed a transthoracic hiatal hernia repair performed in 1965. Mr. Everett also had angina with a history of one or two myocardial infarctions in 1970; he was on medication for the angina. The hiatal hernia repair left a surgical scar across his entire left chest, extending from the midportion of the back all the way across his chest and ending right above the stomach, at the lower part of the anterior chest wall, with another scar extending from his epigastric region down the mid-rib and into the lower midline area. During the surgical repair, Mr. Everett suffered a collapsed lung and suffered a great deal of scar tissue visible in his chest x-rays in the area where most of the pain is reported. Most of his pain resulted from the surgical scar tissue rather than the angina, as confirmed by a cardiologist. Mr. Everett was a very debilitated, elderly person, older looking than his 60 years, obese, very pale, with a slow gait; he perspired quite a bit and appeared to be a patient with chronic medical problems. Mr. Everett had been taking Dilaudid on prescription from his previous physician when he became the Respondent's patient. The quantity of Dilaudid prescribed for Mr. Everett did not exceed the maximum recommended dosage. The Respondent tried other medications and therapies to relieve the patient's chronic severe pain, with limited success, and used other methods of treatment for the patient's problems, which included diabetes and high blood pressure. Mr. Everett had been classified 100 percent disabled by the Veterans Administration because of his chronic severe pain. The Respondent concluded that Dilaudid was the only pain medication that would give the patient sufficient relief from pain to enable him to continue his employment and to function in his daily life. The Respondent prescribed Dilaudid in quantities of 2 tablets of 4 mgs. every 4 hours as needed for pain, to patient Harold Stacy for chronic severe pain relating to acute possibly pinched, nerve, lumbosacral low back pain with radiation into the left leg and degenerative arthritis, possible spinal cord tumor, early hypertrophic osteoarthritis, and possible hernitated disc. At age 49, Mr. Stacy was semi-crippled, always requiring a cane while walking and always in a great deal of pain. The hypertrophic arthritis was confirmed by calcium deposits visible on x-ray films. Mr. Stacy was never able to function normally, and could not maintain employment without the pain relief the Dilaudid provided. The Respondent used other medications in an attempt to relieve the pain, but found that Dilaudid was the only medication which would allow Mr. Stacy to work and function in as reasonable a fashion as possible. The Respondent treated Mr. Stacy's physical and health problems with an appropriate variety of treatment methods and medications. The quantity of Dilaudid prescribed for Mr. Stacy did not exceed the PDR recommended dosage. The Respondent prescribed Dilaudid, in dosages of 1-2 tablets of 4 mgs. every 4 hours, to patient Billy Carr for relief of chronic severe low back pain, related to chronic lumbosacral spine strain, chronic prostatitis and spondylolisthesis. Mr. Carr, at age 49, walked with a severe limp, had pain in his perineal area, had difficulty in sitting, and had a deformity in one of his legs due to a pseudoarthritis resulting from a malunion of a fracture of his femur. The Respondent tried several different pain medications and treatment methods, but found that Dilaudid was the only medication which would relieve the pain to allow Mr. Carr to work and enjoy as reasonable a life-style as possible. The quantity of Dilaudid prescribed for Mr. Carr did not exceed the maximum PDR recommended dosage. The Respondent is a board certified family practitioner. The Petitioner's expert witness, Dr. Robert Johnson, is a general practitioner who is not board certified. The Respondent's expert witnesses, Drs. Charles Grant, James Louttit and Clarence Bailey, are board certified in family practice and testified as such. All four expert witnesses testified, and it is so found, that a medically justifiable purpose in treating a patient is determined by the treating physician, and means a treatment which enhances the well-being of a patient and enhances the quality of a patient's life, in a manner the physician feels qualified to render. Reasonable physicians differ in the manner of treating the same condition. Reasonable physicians differ in the manner of treating pain. A person's pain is not measurable. A person's pain threshold is not measurable. One method of determining the level of medication needed to relieve a person's pain is by titration, that is, adjusting the quantity and type of medication to the patient's symptoms. Dilaudid is approved by the Federal Drug Administration for the treatment of pain. The Physician Desk Reference (PDR) does not place a cap on the quantity of Dilaudid to be prescribed for a patient in chronic moderate to severe pain. The analgesic effect of Dilaudid shortens with continued use. Some patients require a greater amount of Dilaudid to relieve pain than other patients. It is a medically justifiable purpose to prescribe Dilaudid to a patient for the relief of moderate to severe pain. It is a medically justifiable purpose to continue to prescribe Dilaudid to a patient for chronic moderate to severe pain. It is ethical, and medically justifiable, for a physician to treat a patient who is already habituated or tolerant to Dilaudid, and who has chronic moderate to severe pain, for the purpose of relieving this pain, since the patient should be given relief from the pain. There is no evidence that any of the four patients treated by the Respondent were drug abusers. It was medically justifiable for the Respondent to prescribe Dilaudid to each of his four patients during the time periods alleged in the Administrative Complaint. The quantities of Dilaudid prescribed by the Respondent to each of the four patients during the time period alleged in the Administrative Complaint were neither excessive nor inappropriate. The evidence is not sufficient to support a finding of fact that the Respondent failed to practice medicine with that level of care, skill and treatment which is recognized by a reasonable and prudent physician as being acceptable, under the circumstances alleged in the Administrative Complaint. There is insufficient evidence to support a finding that the Respondent engaged in repeated malpractice in the treatment of the four subject patients. Dr. Robert B. Johnson, testifying on behalf of the Petitioner as an expert general practitioner, did not feel that it was medically justifiable for the Respondent to prescribe Dilaudid in the quantities alleged, to each of the four patients, and he testified that such quantities were excessive. However, Dr. Johnson neither saw nor examined the patients, and he was not able to tell from reviewing the patient records how much pain any of the four patients were experiencing. Dr. Johnson also testified that, in his opinion, it is a gross departure from acceptable medical practice to prescribe the quantities of Dilaudid in question to a patient with any history other than terminal cancer, and that it would even be a questionable practice for this purpose; that three months would be the maximum length of time Dilaudid should be prescribed to a patient; and that it is not proper for a physician to continue to treat a patient for chronic moderate to severe pain by prescription of Dilaudid in the quantities and over the time periods alleged in the complaint; yet Dr. Johnson could find no physical harm to any of the four patients resulting from the Respondent's treatment. On the basis of the records reviewed, Dr. Johnson could not testify that the Respondent prescribed the Dilaudid in question other than in the course of his medical practice. The opinions of Dr. Johnson, however, were contradicted by the expert opinions of the Respondent's medical witnesses, Drs. Hailey, Grant and Louttit, except for their agreement that the Respondent's patients suffered no physical harm from their treatment by the Respondent, and that the Respondent prescribed Dilaudid to the four subject patients in the course of his medical practice. Where the expert medical opinions are in conflict, the testimony of Dr. Johnson is rejected as less credible than the opinions of Drs. Bailey, Grant and Louttit.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medical Examiners enter a Final Order finding the Respondent, Glenn R. Johnston, M.D., not guilty of Counts I, IV, VII, X and XIII in the Administrative Complaint, and that the Board dismiss the Administrative Complaint with prejudice. THIS RECOMMENDED ORDER entered this 30th day of September, 1983. WILLIAM B. THOMAS, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 30th day of September, 1983. COPIES FURNISHED: Spiro T. Kypreos, Esquire 130 North Monroe Street Tallahassee, Florida 32301 Paul Watson Lambert, Esquire 1114 East Park Avenue Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Department of Professional Regulation, Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 ================================================================= AGENCY FINAL ORDER ================================================================= BEFORE THE BOARD OF MEDICAL EXAMINERS DEPARTMENT OF PROFESSIONAL REGULATION, Petitioner, vs. CASE NO. 83-356 GLENN R. JOHNSTON, M.D., License No. 12142 Respondent. /
The Issue The issue presented for decision in this case is whether Respondent should be subjected to discipline for the violations of Chapter 458, Florida Statutes, alleged in the Administrative Complaint issued by Petitioner on June 24, 2001.
Findings Of Fact Based on the oral and documentary evidence adduced at the final hearing, and the entire record in this proceeding, the following findings of fact are made: Petitioner is the state agency charged with regulating the practice of medicine in the State of Florida, pursuant to Section 20.43, Florida Statutes, and Chapters 456 and 458, Florida Statutes. Pursuant to Section 20.43(3), Florida Statutes, Petitioner has contracted with the Agency for Health Care Administration to provide consumer complaint, investigative, and prosecutorial services required by the Division of Medical Quality Assurance, councils, or boards. At all times relevant to this proceeding, Respondent was a licensed physician in the State of Florida, having been issued license no. ME 0071241. At the time of Patient M. S.’s treatment, Respondent practiced orthopedic medicine in Florida. Respondent is currently employed as an orthopedic surgeon in Pennsylvania and as an assistant professor at the Medical Center of Penn State University. He no longer practices medicine in Florida. On February 11, 1998, Patient M. S., a 41-year-old male, was involved in a motor vehicle accident. He was transported by ambulance to Lee Memorial Hospital in Fort Myers, where he was evaluated by the emergency room physician. Respondent was consulted as the orthopedist on call for the emergency room that evening. When Respondent arrived at the emergency room, Patient M. S. was lying on a stretcher with his lower left leg in provisional traction as applied by the emergency medical technicians at the scene of the accident. Patient M. S. spoke only Spanish, so Respondent had to rely on an interpreter to communicate with him. Respondent observed that the left lower leg was shortened and completely externally rotated, consistent with a comminuted distal femur fracture. A "comminuted" fracture is a fracture in which there are multiple breaks in the bone, with several fragments. Respondent testified that upon touch, Patient M. S.'s leg was like "a bag of marbles." The patient’s right leg was not fractured but had a six-centimeter deep laceration over the shin that went down to the bone. There was a less than one-centimeter superficial wound over the left distal, anterior thigh, caused by a spike of bone fragment that had pierced the skin from within. This wound was leaking bloody, fatty material. Bones contain adipose, or fatty, tissue. A fracture of the bone can result in communication of that fatty tissue with the open wound, meaning there is direct contact of the fracture site to the outside of the body. X-rays confirmed Respondent's observation of a comminuted distal femur fracture. Respondent diagnosed Patient M. S. with a large wound to the right leg and "left complex intra-articular femur fracture, grade I open." A "grade I" open fracture, according to the Gustilo and Anderson system for grading open fractures, is a relatively clean wound with a skin fracture of less than one centimeter (cm). Respondent described the femur fracture as one of the worst he had ever seen, with multiple bone fragments and a considerable degree of trauma to the muscle surrounding the fracture. Respondent and both expert witnesses agreed that a fracture of this nature is highly susceptible to infection. Respondent irrigated the right lower leg wound with a Betadine and sterile saline solution, then debrided and closed the wound in the emergency room. "Betadine" is a trade name for povidone-iodine, a topical antiseptic microbicide. Intravenous antibiotics were administered to prevent infection of this deep wound. Respondent then treated the fracture in Patient M. S.’s left lower leg by taking it out of the temporary traction applied by the EMTs, placing a skeletal traction pin in the proximal tibia and transferring the patient to a hospital bed, where he was placed in balanced skeletal traction. As to the small wound on the left leg, Respondent's contemporaneous notes indicate only that it was dressed with Betadine-soaked gauze. The discharge summary for Patient M. S. states that the left leg wound was "irrigated and dressed." Respondent testified that he cleaned and dressed the wound, but did not irrigate it on February 11. Respondent's testimony on this point is credited. The complexity of the fracture to Patient M. S.’s left lower leg and the hospital’s operating room schedule required that the surgery be done on February 14, 1998. Patient M. S. remained in traction in the hospital during this pre-operative period. On February 14, 1998, Respondent conducted orthopedic reconstructive surgery to repair the complex fracture of Patient M. S.’s left lower leg. Respondent attached medial and lateral plates and screws and performed a bone graft. The surgery lasted approximately eight hours. At the conclusion of the surgery, the incisions were dressed and Patient M. S.’s left leg was wrapped in a bulky sterile dressing. Deep drains were placed in the knee and thigh during wound closure to prevent the formation of a deep hematoma, which can be a medium for infection. The nurse's assessment for February 16, 1998, notes a small amount of bloody drainage from the auto collection drainage device. Patient M. S. was running a temperature of 100.1ºF. The nurse's assessment for February 17, 1998, notes a large amount of bloody drainage from the auto collection device on two separate occasions. Subsequently, the assessment notes a "slight odor" from the dressing on Patient M. S.'s left leg surgical incision site. On February 18, 1998, Patient M. S. had a temperature of 102ºF, with an elevated white blood cell count. Respondent evaluated Patient M. S. and observed that the dressing on the left leg was "damp/green tinged" and had a "foul odor of Pseudomonas." Respondent lowered the dressing and found it to be "saturated and green." Respondent concluded that the dressing had been colonized from without by Pseudomonas bacteria, and ordered intravenous tobramycin as a precaution to prevent the bacteria from colonizing to the wound. On both February 17 and 18, there was serosanguineous drainage from the surgical incision on Patient M. S.'s left leg. On February 19, 1998, Patient M. S. ran a temperature of 102.1ºF. Respondent discharged Patient M. S. on February 20, 1998. At that time the patient fulfilled all appropriate discharge criteria. His fever had subsided to a normal temperature and his hemoglobin was stable. Patient M. S. was given discharge instructions by Respondent in writing as well as orally in Spanish. Respondent prescribed the oral antibiotics Keflex and Cipro for two weeks as a further precaution against infection. Patient M. S. was scheduled for a follow-up visit with Respondent on March 4, 1998. Patient M. S. was instructed to call Respondent if he experienced increased pain, numbness or tingling, a fever of 101ºF or higher, tenderness or pain in his calves, or excessive swelling, redness, or drainage. On or about February 26, 1998, Patient M. S. presented to St. Joseph’s Hospital in Tampa with apparent pain plus pus drainage from the surgical incision site on his left leg. He was diagnosed with methicillin resistant Staphylococcus aureus, Enterobacter, and Pseudomonas in his left leg. On or about March 2, 1998, Patient M. S. underwent an above the knee amputation of his left leg due to complications from infection in the leg. Subsequent to discharging Patient M. S. from Lee Memorial Hospital on February 20, 1998, Respondent received no notice of further problems with Patient M. S.’s leg until receiving notice of this action against him. Patient M. S. did not contact Respondent after complications began to develop. St. Joseph's Hospital in Tampa did not contact or consult with Respondent after Patient M. S. presented there. Respondent's first knowledge of any complications from the surgery came when he received notice of this proceeding against his license. Two issues are presented by the course of treatment described above. The first issue is whether Respondent acted within the standard of care by cleaning and dressing the less than one cm open fracture in the emergency room, or whether Respondent should have performed an irrigation and debridement of that wound in the operating room. Respondent is a board certified orthopedic surgeon with a great deal of experience in trauma. This was one of the worst femur fractures he had ever seen. His priorities on the night of February 11 were to acutely address the severe cut on Patient M. S.'s right shin, and to pull the left leg to length prior to surgery. The small left leg wound was "very clean," and in hindsight Respondent questioned whether he should even have classified it as a Grade I open fracture. He cleaned the wound, placed a Betadine dressing on it, then followed "routine procedure" by prescribing prophylactic antibiotics. The agency's expert, Dr. Steven Lancaster, also is a Board-certified orthopedic surgeon who routinely undertakes trauma cases in his practice. Based on the testimony of Dr. Lancaster the standard of care requires urgent irrigation and debridement of all open fractures, and this standard is prescribed by both the American Board of Orthopedic Surgeons and the American Academy of Orthopedic Surgeons. Irrigation involves cleaning an area with saline solution. Debridement involves the trimming of contaminated or devitalized tissue, the removal of foreign material from wounds, and the cleaning of bone and muscle tissue. Dr. Lancaster stated that, absent a life-threatening condition, it is necessary to perform the irrigation and debridement of an open fracture as soon as possible. Patient M. S. faced no life-threatening condition. According to Dr. Lancaster, the urgency is due to the fact that bacteria have already been introduced into the wound at the time of injury. If more than twelve hours pass, the bacteria have colonized, and the wound is more properly considered infected than merely contaminated. Dr. Lancaster testified that the small size of the wound did not change the urgency of performing the irrigation and debridement; microscopic bacteria are as capable of entering a small wound as a large one. Respondent's expert, Dr. Edward Sweetser, is also a board certified orthopedic surgeon with trauma experience, though the majority of his practice is in general orthopedics. Dr. Sweetser testified that he would not have debrided the small left leg wound in the emergency room, and that the standard of care would not require debridement. He noted that it was a very small laceration, that it appeared to be a puncture from within, and that it did not appear to be contaminated. Dr. Sweetser believed that cleaning and covering the wound with Betadine-soaked gauze was sufficient to keep bacteria out of the wound, and that the ordering of an intravenous antibiotic was entirely appropriate for treatment of any open wound. It is found that the agency established by clear and convincing evidence that the standard of care required urgent irrigation and debridement of the small left leg wound. Dr. Lancaster persuasively testified that such observations as the small size of the wound or that the wound appeared "very clean" to the naked eye did not affect the potential for bacterial infection. Respondent offered no rebuttal to Dr. Lancaster's testimony that urgent irrigation and debridement of open fractures is the standard prescribed by the American Board of Orthopedic Surgeons and the American Academy of Orthopedic Surgeons. The agency failed to establish by clear and convincing evidence that Respondent's failure to perform the irrigation and debridement of the left leg wound was the cause of the subsequent infection. All of the testifying orthopedists agreed that an injury such as that suffered by Patient M. S. is highly susceptible to infection from multiple possible sources. Dr. Sweetser persuasively opined that the likely main cause of the infection was the severity of the injury, both to the bone and the soft tissue, and the extended length and extensive exposure of the surgical procedure. The second issue is whether Respondent acted within the standard of care subsequent to the surgery by treating Patient M. S. with prophylactic antibiotics, or whether Respondent should have pursued the more aggressive course of reopening the left leg wound for purposes of taking a deep tissue culture to determine the presence of infection. Respondent did not suspect an inside infection of Patient M. S.'s wound. He knew that an injury of this nature carries a high incidence of infection, and believed that prophylactic antibiotics sufficiently allayed that threat. When he changed the dressing on February 18, Respondent noted serous drainage, which he termed normal given the amount of trauma and the extremely large exposure required to perform the surgery. Respondent also noted the green tinge on the outside of the dressing. When the drainage soaks through to the outside of the dressing, it is not unusual for the outside of the dressing to become colonized by Pseudomonas bacteria, which are abundant in the hospital setting. He had no indication or suspicion that the infection was within the wound. The wound looked "very good," with no redness or purulence, intact with only serous drainage. Respondent put a clean dressing on the wound and, as a precaution due to the outside colonization, ordered tobramycin in addition to the intravenous antibiotics Patient M. S. was already receiving. Respondent noted the fever and elevated white blood cell count, but also noted that Patient M. S. was afebrile with a stable hemoglobin when he was released from the hospital. Fever is common in post-surgical patients for reasons other than infection. The most common cause is the release of pyrogens by soft tissue trauma. Another common cause of fever is atelectasis, small areas of collapse in the lung resembling pneumonia. Patient M. S. received multiple transfusions, which can cause fever due to the body's immune response. In some instances, antibiotics themselves can cause a fever. Respondent testified that, after spending eight hours in surgery, he would have "done anything" to save Patient M. S.'s leg. If he had suspected an inside infection, he would have taken the patient back into the operating room, reopened the wound, and obtained a deep culture. Dr. Lancaster testified that Respondent fell below the standard of care by discharging Patient M. S. "with a febrile condition and, potentially, with an infected leg." Dr. Lancaster believed that the fever and elevated blood count required an explanation, and that Patient M. S. should not have been discharged until some effort was made to identify whether there was an infection. Dr. Lancaster's opinion is of questionable value because Patient M. S. was not running a fever and showed a stable hemoglobin on the date of discharge. Dr. Lancaster did not directly address how the patient's apparent stability on February 20 might affect his opinion. Dr. Lancaster acknowledged that post-surgery fever is common and not necessarily indicative of an infection. Dr. Sweetser's credible testimony is that, "based on reasonable medical probability," Patient M. S.'s discharge on February 20 did not violate the standard of medical care. He based his opinion on the facts that the patient had no fever, no increasing swelling in the wound, no redness, no purulent drainage, and no increase in pain. Nothing in the medical record provided a reasonable basis for Respondent to reopen the wound, and that reopening the wound delays healing and itself heightens the risk of infection. It is found that the Agency failed to establish by clear and convincing evidence that the standard of care required reopening the left leg wound for purposes of taking a deep tissue culture to determine the presence of infection. The objective facts in the medical record make it reasonable that Respondent did not suspect infection in the wound on Patient M. S.’s left leg. Therefore, his failure to obtain a wound culture or to consult with an infectious disease specialist was not outside the standard of care required of him in this case. Both experts agreed that the chances of saving Patient M. S.'s leg would have been better if Respondent had been consulted when the patient presented at St. Joseph's Hospital in Tampa. The Agency's expert, Dr. Lancaster, stated that when a patient has a complication, it is better practice for the operating surgeon to treat it. Dr. Sweetser testified that the operating surgeon possesses information for which the written notes and x-rays cannot substitute.
Recommendation Upon the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Department of Health, Board of Medicine, enter a final order finding that Respondent violated Section 458.331(1)(t), Florida Statutes, and imposing the following penalty: a reprimand, 10 hours of Continuing Medical Education in orthopedic medicine to be completed within 12 months of the final order, and payment of an administrative fine in the amount of $250.00. DONE AND ENTERED this 4th day of February, 2002, in Tallahassee, Leon County, Florida. __________________________________ LAWRENCE P. STEVENSON 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 4th day of February, 2002. COPIES FURNISHED: Kim M. Kluck, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Bruce M. Stanley, Esquire Henderson, Franklin, Starnes & Holt, P.A. Post Office Box 280 Fort Myers, Florida 33902 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Theodore M. Henderson, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
The Issue 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 Whether Daniel S. Merklinger, a minor, qualifies for coverage under the Florida Birth-Related Neurological Injury Compensation Plan.
Findings Of Fact Preliminary findings Lorna Merklinger and Scott Merklinger are the natural parents and guardians of Daniel S. Merklinger, a minor. Daniel was born a live infant on November 17, 2001, at Florida Hospital Waterman, a hospital located in Eustis, Florida, and his birth weight exceeded 2,500 grams. The physician providing obstetrical services at Daniel's birth was Jose Ramon Gonzalez, M.D., who, at all times material hereto, was a "participating physician" in the Florida Birth-Related Neurological Injury Compensation Plan, as defined by Section 766.302(7), Florida Statutes. Daniel's birth and postnatal course At or about 6:50 a.m., November 16, 2001, Mrs. Merklinger, with an estimated delivery date of November 23, 2001, and the fetus at 39 weeks gestation, presented to Florida Hospital Waterman, for induction of labor. At the time, Mrs. Merklinger's membranes were noted as intact, and vaginal examination revealed the cervix at fingertip dilation, effacement at 60 percent, and the fetus at -1 station. Uterine contractions were noted as mild, irregular and with a duration of 60 seconds, and external fetal monitoring revealed a reassuring fetal heart rate, with a baseline at 130 to 140 beats per minute. Pitocin induction was started at or about 7:00 a.m., and continued until 3:51 p.m., when it was discontinued following a vaginal examination that revealed no progress in cervical dilation.3 Given the lack of progress, Cytotec was inserted vaginally at 4:34 p.m., and again at 1:10 a.m., November 17, 2001. From 8:18 a.m., when Pitocin induction was restarted, until 7:00 p.m., when Dr. Gonzalez ordered Mrs. Merklinger prepared for delivery, Mrs. Merklinger's labor progress was slow, but, until 6:20 p.m., when prolonged decelerations in the 90 to 102 beat per minute range were noted, fetal monitoring continued to reveal a reassuring fetal heart rate. Starting at 7:25 p.m., vacuum delivery was attempted on three occasions, unsuccessfully, and between 7:30 p.m., and 7:32 p.m., forceps were applied three times. Then, after delivery of Daniel's head, a right shoulder dystocia was noted, and relieved with suprapubic pressure and McRoberts maneuver, and Daniel was delivered at 7:42 p.m. At delivery, Daniel was depressed (limp, with poor respiratory effort), and required resuscitation measures, including oxygen and bag/mask for four to five minutes. Apgar scores were recorded as 3, 6, and 8, at one, five, and ten minutes, respectively.4 Following delivery, Daniel was transported to the nursery, where he remained until approximately 6:10 p.m., November 18, 2001, when he was transferred via ambulance to the neonatal intensive care unit at Arnold Palmer Hospital for Children & Women. Reason for transfer was noted as fractured skull and subdural hematoma. Daniel's history and diagnoses at Florida Hospital Waterman were summarized by his attending physician (Dr. Thomas Carlson) in Daniel's discharge summary, as follows: HISTORY OF PRESENT ILLNESS: Baby boy Merklinger is a product of a pregnancy complicated by a maternal age of 41, maternal chronic hypertension and asthma. Labor was induced with Pitocin. Toward the termination of delivery, the child became distressed and delivery was urgent . . . . Mother suffered a third degree laceration in the rapid delivery, and the child's head was quite bruised . . . . I was called at the time of delivery and was in Orlando. I transferred the call to the doctor on call, Dr. Burgos. When she was reached, the baby had already been born and was breathing, so she elected not to go in at that time. The baby was born at 1958 [sic] hours. My examination was complete and note written at 2130 hours. The child was, according to the nurse, bagged for approximately 5 minutes postpartum, but then did well. When I saw the baby under the warmer, I immediately noticed severe bruising and abrasions of the forehead, on through the occiput with large quantity of subcutaneous blood under the scalp. The right cornea was noted to be cloudy. The chest was clear. Heart regular without murmur. The child was breathing well with good oxygen saturation, good capillary refill on room air. There was also noted an apparent fracture of the right clavicle, and the left arm had some decreased movement probably from pulling of the nerve plexus at birth. Impression at that time was traumatic birth doing well . . . . The following morning, it was noted that the hemoglobin and hematocrit were dropping . . . . It was noted that the head circumference was growing . . . . Intravenous antibiotics and fluids were begun. I ordered a CT of the head, chest x-ray and came in to see the child. IV antibiotics were begun. The chest x-ray showed mildly displaced right clavicular fracture. The heart and lungs appeared normal. No pneumothorax identified. CT of the brain without contrast revealed a frontal subdural hematoma, 11 mm in thickness with mild mass effect and midline shift. Scalp hematoma noted on physical exam was also present. [Mildly] depressed left frontal skull fracture, minimally displaced left posterior fossa fracture at the lambdoid suture inferiorly. A right anterolateral scalp hematoma with slight suture separation at coronal suture, and a minimally depressed fracture extending back towards the right lambdoid. No intraventricular hemorrhage. With this finding, it was elected to immediately transfer the child to Arnold Palmer Hospital because a neuro surgeon was needed. The child was then transferred out. DIAGNOSES Traumatic birth. Multiple skull injuries with depressed fractures and subdural hematomas. Traumatized right cornea. Mild Erb's palsy on the left. Fractured right clavicle. At approximately 7:11 p.m., November 18, 2001, Daniel was admitted to Arnold Palmer Hospital. Upon admission, Daniel was examined by Dr. Michael McMahan, who noted that: . . . On arrival of the team, tonic colonic motions of the lower extremity noted, could not be suppressed. Phenobarbital . . . given . . . . Ampicillin and Claforan begun after blood culture obtained The infant has been feeding well, but with question of seizures infant was made n.p.o. and placed on IV fluids PHYSICAL EXAM: . . . Irritable. Molding. Severe bruising of the scalp. Very large caput as well as cephalohematomas. Question of subgaleal bleed. Fontanelle is full. Eyes are open. Cloudy right cornea . . . . Chest: Right clavicle with palpable fracture/crepitus . . . . Neuro: Normal tone and motor strength, moves all extremities . . . . Bruises on chest. IMPRESSION: Term AGA male Intracranial bleed. Possible seizures. Rule out sepsis On November 18 and 19, 2001,5 with a diagnosis of "depressed left temporal skull fracture with underlying epidural hematoma," Daniel underwent a "[l]eft temporal craniotomy for elevation of skull fracture and evacuation of epidural hematoma," and "[p]lacement of left frontal external ventricular drain with Codman monitor." The surgeon was Eric Trumble, M.D., a pediatric neurosurgeon, who noted that Daniel "tolerated the procedure well, was sent to NICU postoperatively." On November 27, 2001, at 10 days of age, Daniel was discharged home on Phenobarbital, with instructions to follow up with his pediatrician within one week, Dr. Trumble in 2-3 weeks, and the development center. Discharge examination noted: . . . active, alert, no distress. Head and neck: Large cephalohematoma. Incision healing. Chest clear. No murmur. Abdomen soft. Normal motor strength. Slightly decreased tone left arm. Discharge summary noted the following problems addressed during Daniel's hospitalization: Depressed skull fracture: Neurosurgery consult obtained. Infant was taken to OR on November 18 for left temporal craniotomy and evacuation of EDH. CT scan of the head on November 19 showed extensive scalp swelling, multiple nondepressed skull fractures, small amount of intracranial hemorrhage, question status of intracranial pressure with low density changes inferiorly raising possibility of increased intracranial pressure. Infant continued on phenobarbital. Skull incision clean and healing. Large cephalohematomas remain present. MRI was done on November 27. This showed scalp hematoma which crosses the midline over the vertex, evidence for parenchymal hemorrhage adjacent to the atria/occipital horn, right lateral ventricle mixed signal intensity consistent with evolving hemorrhage. Additionally, posterior extra-axial hemorrhage is appreciated, likely subdural hemorrhage. Small amount of hemorrhage also seen along the interhemispheric fissure towards the vertex. Small areas of parenchymal signal abnormality seen in the left periventricular parenchyma likely related to ventricular shunt placement. An increased signal intensity is seen on both ADC and T2 weighted sequences within the white matter of the right parieto-occipital region likely reflecting edema. No midline shift. Midline structures intact. No ventriculomegaly. Infant has slightly decreased tone in the left arm compared to the right. No seizure activity noted. He is discharged home on phenobarbital 6 mg p.o.q. 12 hours for follow up with Dr. Trumble in 2-3 weeks . . . . Possible sepsis: Treated with ampicillin and Claforan times seven days. Blood culture negative. * * * 5. Ophthalmology: Eye exam on November 20 with diffuse hemorrhage OU. Follow up on November 27 improved, but still significant hemorrhage present. Guarded visual prognosis OD. For recheck in three weeks with Dr. Gold. Final diagnoses were: Term AGA (appropriate for gestational age) male. Depressed skull fracture, status post evacuation of hematoma. Possible seizures. Possible sepsis. Left corneal opacification. Anemia. Daniel's subsequent development Following discharge from Arnold Palmer Hospital, Daniel was referred to Pediatric Neuroscience, P.A., where he was initially followed by Dr. Trumble, who had performed his surgery. Dr. Trumble first examined Daniel on December 20, 2001, and in a letter to Daniel's pediatrician (Thomas Carlson, M.D.) reported his impressions, as follows: I have just had the opportunity to see Daniel with his mother in the neurosurgery clinic today. As you know, he is a 1-month- old child whose last neurosurgery intervention was a craniotomy for evacuation of epidural hematoma on 11/19/01. He has been doing very well since that time without headaches, nausea or vomiting and meeting developmental milestones. On examination, Daniel is bright, alert, and interactive. He weighs 9 pounds 8 ounces and has a head circumference of 37.25 cm. His incision is well healed. He remains neurologically intact. Eom's are intact. Disc margins are sharp bilaterally. His anterior fontanelle is soft and flat. He does have a bony ridge palpable about the posterior aspect of the left craniotomy and a scalp ridge in the right occipital region. I am pleased with the improvement Daniel has had thus far. I would like to see him back in the neurosurgery clinic in 3/02 with a repeat head CT for routine follow-up. He may discontinue all neuro-active medications from my stand-point, including anti- convulsants. Dr. Trumble next examined Daniel on March 14, 2002, at which time he noted that Daniel had a "progressive right occipital flatness with the right ear anterior to the left and subtle right frontal bossing," and prescribed an occipital molding band. Otherwise, there was no change in Dr. Trumble's impression of Daniel's progress, and he noted the "repeat head CT done at Arnold Palmer Hospital on 3/5/02 . . . was intracranially normal. The fractures healing well." Following March 14, 2002, Daniel was seen by Dr. Trumble on June 10, 2002; July 22, 2002; and September 26, 2002, during which time Daniel's occipital flatness improved and Dr. Trumble remained pleased with Daniel's progress. Dr. Trumble's impressions for this time period may be gleaned from the text of his letter to Daniel's pediatrician of September 26, 2002, as follows: I have just had the opportunity to see Daniel with his mother in the neurosurgery clinic today. As you know, he is a 10- month-old child whose last neurosurgical intervention was a craniotomy for evacuation of epidural hematoma on 11/19/01. He has been doing very well since that time without headaches, nausea or vomiting and meeting developmental milestones. His right occipital flatness has improved since he obtained his occipital molding band, initially in 3/02 with a replacement in late 5/02. He comes in for routine follow-up today. Mother notes that he was recently developmentally graded advanced.[6] On examination, Daniel is bright, alert, and interactive. He weighs 16 pounds, 12 ounces and has a head circumference of 44.3 cm. His left temporal incision is well healed. He remains neurologically intact. Eom's are intact. Disc margins are sharp bilaterally. His anterior fontanelle is soft and flat. He has mild right occipital flatness, with his right ear anterior to his left and mild, compensatory right frontal bossing. These findings are very subtle and much improved since he was placed in the occipital molding band. As part of his ongoing work-up, Daniel had a repeat head CT that was intracranially normal. His bone flap is integrating well. I am pleased with the improvement Daniel has had thus far. I do not feel that neurosurgical intervention is warranted at this time. We will be happy to see them back at any time but don't feel that they need[] routine neurosurgical follow-up. Following Dr. Trumble's September 26, 2002, evaluation, Daniel has been followed by Ronald Davis, M.D., a pediatric neurologist. Dr. Davis first evaluated Daniel on June 27, 2003, and reported the results of his evaluation to Daniel's pediatrician, as follows: I had the opportunity to evaluate Daniel. As you well know, he is a 19-month-old who was born with a delivery complicated by multiple skull fractures and subdurals as a result of forceps delivery. He subsequently had some transient seizure activity and was on Phenobarb, but was able to wean off. He underwent a number of surgical repairs, but developmentally has done well. Over the course of the last number of weeks he had events where he vomits out of the blue, turns pale, cold and clammy. He has some eye deviation and becomes unresponsive and still. It lasts for a number of minutes and he can be sleepy afterwards. He has had somewhere between 7-8 of these events. They are very discrete events without any clear tonic or clonic activity. They have been occurring on a cycle range about every 4-8 days. As a result of this he has had an EEG. It actually demonstrated the presence of right frontotemporal sharp wave discharges. Interestingly, in the past mother had wondered whether or not he had also had some headache like activities where he would seem to grab his head and wince in pain. Though he has had a number of CT scans he has not had an MRI. He has not been started on any medications. PAST MEDICAL HISTORY: Otherwise notable for the subdurals and the fractures. He has some right facial injury and a right orbital injury. * * * ON EXAM: General: He is a well-developed, healthy- appearing male with some slight facial asymmetry, right over left HEENT, patient is normocephalic. Pupils are reactive . . . . . NEUROLOGICAL EXAM: Mental Status: He was awake, alert, oriented. He was attentive and interactive. His speech was fluent. He had no anomia. He could follow directions appropriately. He had good right-left orientation. Cranial nerves II-XII: Intact. Full EOM's. Fundi were sharp bilaterally. Tongue was midline. Motor Exam: Normal tone and bulk with 5/5 strength. He did not have a drift. Sensory Exam: Intact to light touch, vibration and cold. Reflexes: 2+. Toes: Down. Coordination and Gait: No primary ataxia, dysmetria or tremor. He had appropriate gait for age. IMPRESSION: Daniel is a 19-month-old with seizure-like episodes, likely partial in nature with an abnormal EEG with trauma as the most likely inciting event. PLAN: At this point I am going to arrange for an MRI to rule out any structural abnormality. I have given them Diastat 5 mg to use for any prolonged events and they are going to think over the use of long-term antiepileptic medication. The side effects and risks of going on medicine as well as not going on antiepileptic medication on a routine basis were reviewed. Following an MRI, Daniel had a follow-up visit with Dr. Davis on August 26, 2003. Dr. Davis reported the results of that evaluation, as follows: I had the opportunity to follow-up with Daniel. As you well know, he is our nearly 2-year-old who suffered traumatic fractures as a result of delivery by forceps, as well as the presence of subdurals. Since his last visit he has had an MRI and EEG. His EEG had, of course, demonstrated the presence of frontotemporal sharp wave discharges on the right. This did correlate with MRI abnormality. The MRI actually demonstrated thickening cortex in that region, as well as focal cystic encephalomalacia there, as well as in the right gyrus rectus and the basal ganglia. Additionally, there was periventricular leukomalacia noted bilaterally. He continues to do well developmentally. There are some mild delays, but he continues to advance without any evidence of regression or plateauing. * * * NEUROLOGICAL EXAM: Mental Status: He was awake, alert, attentive and interactive. His speech is mildly disarticulate, but fluent. He is able to engage appropriately. Cranial nerves II-XII: Intact with some estropia of the right. Motor Exam: Demonstrates symmetric movement. Reflexes: 1+ Coordination and Gait: No primary ataxia. IMPRESSION: Daniel is a nearly 2-year-old with traumatic injury was described with resultant mild developmental delay, periventricular leukomalacia and an abnormal EEG. PLAN: At this point we will just continue to have the Diastat 5 mg to use for any breakthrough seizures. We will continue to hold off on any routine antiepileptic medication as he has not had any breakthrough seizures. Dr. Davis continues to follow Daniel's progress. On his most recent evaluation of July 19, 2004, Dr. Davis noted: I had the opportunity to follow-up with Daniel. As you well know, he is our young man with history of traumatic fractures from delivery by forceps and subdural hematoma. He has abnormal EEG and periventricular leukomalacia on MRI. He continues to do relatively well. He has not had any significant seizure activity, though mother does relate a time when he appeared to be having some type of partial spell in the face of being overheated. Interestingly, the grandfather also reports that he sees Daniel put his head down at times as if he has some transient and/or paroxysmal head pain which can last for a number of seconds. However, he did have a repeat EEG back in June which continued to demonstrate the presence of left frontocentral spike and wave discharges, as well as independent right frontocentral spike and wave discharges. Cognitively he continues to advance. There appears to be no regression. ON EXAMINATION: General: He is well developed and healthy appearing. . . . HEENT. patient is normocephalic. Pupils are reactive . . . . NEUROLOGIC EXAM: Mental Status: He was awake, alert, attentive, interactive and engaging. His speech was mildly disarticulate, but fluent. Cranial nerves II-XII: Intact. Full EOM's, though mild esotropia is noted of the right. He has some mild asymmetry of his facies. Motor Exam: Normal tone and symmetric movement. Reflexes: 1+. Coordination and Gait: No primary movement disorder. IMPRESSION: Daniel is a young man with traumatic brain injury in the face of periventricular leukomalacia with mild developmental issues and abnormal EEG. PLAN: At this point I am concerned a little bit about these events that are both described by the grandfather, as well as the single event noted by the mother. Should these recur and/or persist I am going to arrange for a more prolonged ambulatory study. In the meantime we will continue to have the Diastat available and monitor him closely. On February 9, 2004, following the filing of the claim in this case, Daniel was, at Respondent's request, examined by Michael Duchowny, M.D., a pediatric neurologist. Dr. Duchowny reported the results of his neurology examination, as follows: PHYSICAL EXAMINATION reveals an alert, cooperative, well-developed and well- nourished 2-year-old boy. Daniel weighs 24 pounds and is 34 inches tall. The skin is warm and moist. There is one café-au-lait spot on the right thigh. There are no other neurocutaneous stigmata and no somatic dysmorphic features. The head circumference measures 48.5 cm, which is at the 50th percentile for age match controls. A bony ridge is palpated over the right skull vault and there is also a small area of depression. There are no facial asymmetries. There is some reddening beneath the eyes compatible with an allergic diathesis. The neck is supple without masses or thyromegaly. Bilateral anterior and posterior cervical adenopathy is palpated as well as small post auricular lymph nodes. The lungs' fields are clear and the heart sounds reveal a grade 2/6 innocent ejection systolic murmur. There is no palpable abdominal organomegaly. The abdomen is soft and non-tender. Peripheral pulses are 2+ and symmetric. NEUROLOGICAL EXAMINATION reveals an alert, well developed, cooperative and sociable 2- year-old. Daniel interacts very well and shows a very high level of curiosity. He was not overly defensive and cooperated fully for the evaluation. Daniel has an appropriate attentional span for his age and spoke in long phrases. He articulated his needs well. He also anticipated maneuvers and assisted in getting himself dresse[d] and undressed. Cranial nerve examination reveals full visual fields to direct confrontation testing. I can see no evidence of corneal scarring. The pupils are 2 to 3 mm and react briskly to direct and consensually presented light. A brief funduscopic examination was unremarkable. The extraocular movements are full and conjugate. There are no facial asymmetries. The tongue and palate move well. The uvula is midline. Motor examination reveals symmetric strength, bulk and tone. There are no adventitious movements and no focal weakness or atrophy. The deep tendon reflexes are 2+ and symmetric and there are no pathologic reflexes. Both plantar responses are downgoing. Daniel's stance is narrowly based and he walks with good stability and symmetric arm swing. He turns crisply. He is able to get up from a sitting position without difficulty. Sensory examination is intact to the withdrawal of all extremities to stimulation. Neurovascular examination reveals no cervical, cranial or ocular bruits. There are no temperature or pulse asymmetries. Daniel is able to grasp with either hand and transfers readily. In SUMMARY, Daniel's neurological examination reveals no significant findings. He does have some cranial dysmorphism secondary to his previous skull fractures and surgery. However, Daniel does not show evidence of a substantial mental or motor impairment . . . . Coverage under the Plan Pertinent to this case, coverage is afforded by the Plan for infants who suffer a "birth-related neurological injury," defined as in "injury to the brain . . . caused by oxygen deprivation or mechanical injury, occurring in the course of labor, delivery, or resuscitation in the immediate postdelivery period in a hospital, which renders the infant permanently and substantially mentally and physically impaired." § 766.302(2), Fla. Stat. See also §§ 766.309 and 766.31, Fla. Stat. In this case, Petitioners and NICA are of the view that Daniel suffered an injury to the brain caused by the forceps delivery, but that he was not rendered permanently and substantially mentally and physically impaired. In contrast, Intervenors are of the view that Daniel's brain injury did result in permanent and substantial mental and physical impairment. The significance of Daniel's impairment To address the significance of any impairment Daniel may have suffered, the parties offered the records related to Daniel's birth and subsequent development, pertinent portions of which have been addressed supra (Respondent's Exhibits A-G); a color photograph of Daniel taken within the first 24 hours of birth (Intervenors' Exhibit 1); the deposition of Michael Duchowny, M.D., an expert in pediatric neurology (Respondent's Exhibit H); the deposition of Ronald Davis, M.D., an expert in pediatric neurology (Respondent's Exhibit K); the deposition of Petitioner Lorna Merklinger (Respondent's Exhibit I); the deposition of Petitioner Scott Merklinger (Respondent's Exhibit J); the deposition of Loren Mann, Daniel's maternal grandmother (Intervenors' Exhibit 3); the deposition of Ruth Merklinger, Daniel's paternal grandmother (Intervenors' Exhibit 4); and the deposition of George Merklinger, Daniel's paternal grandfather (Intervenors' Exhibit 2). Dr. Duchowny, as revealed in his deposition, was of the opinion, based on his review of the medical records and his neurologic evaluation of Daniel on February 9, 2004, that Daniel was neither mentally nor physically impaired, much less substantially mentally and physically impaired, as required for coverage under the Plan. Dr Duchowny described his evaluation and conclusions, as follows: Q. Doctor, when you examined Daniel Merklinger, what physical and neurological exams did you conduct on him specifically? What did you have him do or what did you observe? A. Well, his weight and height were recorded. I looked at his skin. I looked at his head. I felt his head, measured his head circumference. Observed his face, his mouth, his throat. I looked at and palpated his neck. I listened to his chest. I listened and felt his abdomen, looking for his internal organs, and palpated his extremities and his peripheral pulses. On the neurological examination, I observed his behavior and his communication patterns, both expressive and receptive. I looked at his attention span, his social abilities, his ability to engage me in both the examination and in conversation. I looked at his ability to participate in the expected activities of daily living within a limited sense; for example, how he dressed or undressed himself. I certainly observed his behavior, both with respect to me and with respect to his family. I performed a cranial nerve examination, which included an examination of the eyes, of the facial movements, and an observation of his hearing abilities. I also looked at the way his mouth moved, how he swallowed, how his tongue moved, whether or not there was any drooling. I further looked at his motor abilities, including the movements of his extremities, his arm and legs. I evaluated his muscle tone. I looked to see if there was any atrophy, any abnormal movement, any lack of movement, any stiffness in any of his limbs. I made sure that his gait was stable, that it was symmetric, that his coordination was appropriate for his age, that his hand use was appropriate, and that he had bimanual dexterity, that he transferred between hands, that he had good, fine motor coordination and pincer grasp. I looked at his ability to show evidence of good muscle strength; for example, getting up from a sitting position, his ability to walk and turn and show coordinated movements. I examined him for sensation, just looking at the way he moved his arms and legs in response to my touch and pressure, and also examined the patterns of the blood flow to his head by checking his neck and head for temperature, for the pulses, making sure there were no abnormalities or asymmetries. I also listened to his neck and head to make sure that there were no abnormal sounds emanating from the vessels supplying blood to his head. Q. Was his behavior age appropriate? A. I thought so, yes. Q. Was his communication ability age appropriate? A. Yes. Q. Was his motor ability and coordination age appropriate? A. Yes. Q. Did you see anything during your examination that led you to believe that he was physically impaired? A. No. Q. Did you see anything in your examination that led you to believe he was mentally impaired? A. No. Q. Do you have an opinion regarding whether or not he is substantially and permanently physically impaired? A. Yes. I do not belie[ve] he is substantially impaired, mentally or physically. (Respondent's Exhibit H, pages 34-37). Dr. Davis, as revealed in his deposition, was of the opinion that Daniel suffered some developmental delays, but articulated no findings from which one could reasonably conclude that Daniel was either substantially mentally or physically impaired. Regarding Daniel's developmental delays, Dr. Davis described them as follows: Q. Okay. And have you noticed . . . [any developmental issues] in your treatment of Daniel? A. He has some disarticulation of his speech. In other words, his speech is difficult to understand. There is some slight inconsistencies in his motor skills, so you would see that. But then, also, when you go through some of the -- just the typical other developmental learning issues, he has some difficulty with that as well. * * * Q. . . . [W]hen I was asking you about developmental delays, could you be more specific about what it is that you base that upon as a clinical symptom? A. In particular for Daniel or -- Q. Yes, yes. Specifically for Daniel. A. He has some difficulty with his speech, which is the motor component of the way he moves his mouth, if you will, that sort of formation of words. There is some movement abnormalities noted in his face, some asymmetry there. And then his gait is a little -- this is more from recollection than from others, because I don't remember documenting it. But his -- he's a little bit wide based in his stance, so there are more subtle degrees there of his motor difficulties. But the more prominent is his disarticulation of speech, that formation, the mechanical formation of words. * * * Q. All right. Earlier, I believe you described his -- the motor dysfunction he's currently displaying as mild; is that correct? A. I think that's in my note, yes. * * * Q. You . . . mentioned that the -- that Daniel has some developmental delays. What were you referring to? Was it just the speech and the -- A. And the motor, yes. Q. Okay. And could you -- I think you've already gone over this a couple times, but for the motor dysfunction, other than the asymmetry in his face and speech disarticulation, was it anything other than the widened gait? A. Not that I have documented here, no. (Respondent's Exhibit K, pages 24, 29, 64, 65, and 69). Notably, Dr. Davis did not opine that, or disclose any findings that would support a conclusion that, more likely than not, Daniel was mentally impaired, that Daniel was substantially physically impaired, or that Daniel's brain injury would, at any time in the future, result in substantial mental or physical impairment. As for the deposition testimony of Daniel's parents and grandparents, with regard to his current mental and physical presentation, they were all of the opinion, to the extent they were called upon to express one, that Daniel's mental and physical development were age appropriate. Their concerns for Daniel, to the extent they expressed them, were speculative in nature, and premised on their uncertainty as to whether Daniel's brain injury would, either through the manifestation of persistent seizure activity or developmental deficiencies, adversely affect him in the future. Such concerns are certainly natural, but insufficient to support a conclusion that, more likely than not, Daniel's brain injury has rendered him, or will render him, permanently and substantially mentally and physically impaired.
