The Issue At issue in the proceeding is whether Shayla Adame, a minor, suffered an injury for which compensation should be awarded under the Florida Birth-Related Neurological Injury Compensation Plan.
Findings Of Fact Fundamental findings Petitioner, Sheila Adame, is the mother and natural guardian of Shayla Adame, a minor. Shayla was born a live infant on April 1, 1996, at University Medical Center, a hospital located in Jacksonville, Florida, and her birth weight exceeded 2,500 grams. The physicians providing obstetrical services during the birth of Shayla included Drs. Pierce, Murray, and Sanchez, who were at all times material hereto "participating physician[s]" in the Florida Birth-Related Neurological Injury Compensation Plan, as defined by Sections 766.302(7) and 766.314(4)(c), Florida Statutes. Ms. Adame's antenatal course and Shayla's birth Ms. Adame's antepartum course was without any apparent prenatal complication of significance; however, on November 17, 1995, at 17 weeks and 6 days gestation, the fetus was noted in a breech presentation (presentation of the buttocks of the fetus to the cervix), with placenta anterior, a condition that would persist through the course of Ms. Adame's pregnancy.1 Given the breech presentation, an external cephalic version (a manipulation of the fetal body applied through the abdominal wall of the mother to convert a breech presentation to a head presentation), referred to as an ECV in the medical records, was attempted on two occasions. The first procedure occurred on March 22, 1996, at 37 weeks gestation, and despite three attempts proved unsuccessful. The second procedure occurred on March 29, 1996, and, with one attempt, likewise proved unsuccessful. The progress notes of that attempt reveal the following: . . . ECV attempted but buttocks (presenting part) engaged and unable to elevate to perform ECV . . . [Patient] desires TOL [Trial of Labor]. CT pelvimetry [measurement of the dimensions and capacity of the pelvis to assess clinical adequacy] ordered for 4/1/06 . . . . At the time, the cervix was noted as closed and thick. At 7:35 a.m., March 31, 1996, Ms. Adame telephoned University Medical Center, the entity that provided her antenatal care, and reported that she had "[s]tarted vag[inal] bleeding last night more than spotting, less than period. Bright Red." Shortly thereafter, at 7:45 a.m., the duty nurse returned Ms. Adame's telephone call, and was informed by Ms. Adame that she was now having contractions. In response, the duty nurse told Ms. Adame to come to the hospital immediately if she experienced any more evidence of bleeding, if she experienced decreased fetal movement or no fetal movement in 2 hours, or if she experienced regular uterine contractions for 2 to 3 hours of 30 seconds duration, with 6 or more an hour. Approximately 4 1/2 hours later, at 12:15 p.m., March 31, 1996, Ms. Adame presented at University Medical Center complaining of vaginal bleeding and lower abdominal pain (described as "cramps"). External fetal monitor (EFM) and tocograph (TOCO), an instrument for measuring uterine contractions, were applied. At the time, fetal monitoring revealed a fetal heart rate of 140 to 150 beats per minute, positive long term variability and no decelerations. TOCO revealed no evidence of contractions. Vaginal examination showed the cervix at 1 centimeter dilatation, effacement at 50 percent, and the fetus high posterior. Assessment was term breach, latent labor, and the plan was to proceed with the CT pelvimetry previously scheduled for April 1, 1996. At 2:00 p.m., Ms. Adame was discharged home, with labor precautions. A little less than 6 hours later, at 7:42 p.m., March 31, 1996, Ms. Adame (with an estimated date of delivery of April 13, 1996) again presented at University Medical Center, this time complaining of spontaneous rupture of membranes (SROM) at 7:00 p.m., with "green fluid" (meconium stained fluid), and some uterine contractions. EFM and TOCO were applied, and revealed a stable fetal heart rate and positive uterine contractions. Subsequent vaginal examination revealed the cervix at 2 centimeters dilatation, effacement complete, and the fetus at station-1, with a moderate amount of "green fluid pouring from the os [ostium uteri]". CT pelvimetry revealed a clinically adequate pelvis and it was resolved to proceed with a vaginal breech delivery. Ms. Adame's labor progressed steadily until at or about 10:30 a.m., April 1, 1996, when dilatation and effacement were noted as complete, and the fetus at station +2. In the interim, fetal monitoring was reassuring, although there were occasional declarations noted and an increase in the fetal heart tone base line to 160-190 beats per minute (described in the records as protracted accelerations or persistent fetal tachycardia) associated with a slow rise in maternal temperature, which was noted to peak at 100.6 degrees Fahrenheit at 8:31 a.m., April 1, 1996. Given the elevation in temperature, blood cultures were ordered, and Ms. Adame was accorded ampicillin and gentamycin. Ms. Adame's second stage of labor was not prolonged, extending from approximately 10:30 a.m., until 11:36 a.m., when Shayla was delivered. As for the delivery, the delivery summary describes a delivery which, albeit a breech vaginal delivery, was easy and without incident. The summary further reflects that on delivery of the infant's head she was Delee suctioned, while the cord was clamped and cut, and accorded free flow oxygen. Following delivery, Shayla was handed off to the pediatrician, who noted that upon presentation Shayla was cyanotic with poor respiratory effort; however, following suctioning, stimulation, and positive pressure ventilation (PPV) for 15 seconds Shayla turned pink and cried spontaneously. Apgar scores were recorded as 3 at one minute and 8 at five minutes. The Apgar scores assigned to Shayla are a numerical expression of the condition of a newborn infant, and reflect the sum points gained on assessment of heart rate, respiratory effort, muscle tone, reflex/irritability, and color, with each category being assigned a score ranging from the lowest score of 0 through a maximum score of 2. As noted, at one minute Shayla's Apgar score totaled 3, with heart rate, respiratory effort, and reflex/irritability being graded at 1 each, and muscle tone and color being graded at 0. At five minutes, Shayla's Apgar score totaled 8, with heart rate, respiratory effort, and reflex/irritability being graded at 2 each, and muscle tone and color being graded at 1 each. Notably, while Shayla's one-minute Apgar was below normal, such occurrence is not uncommon with a breech delivery, and her five-minute Apgar score, which is most predictive of neurologic outcome, was normal. Shayla was admitted to the newborn nursery at 12:00 (noon). Admission assessment and physical were essentially normal. Generally, she was described as pink, active, and with good cry; respiration as regular and unlabored; mouth with good suck and no cleft; spine straight with no apparent abnormality; and neurologic examination revealed good symmetrical muscle tone, positive suck, and positive moro. Notwithstanding, Shayla was noted with poor feeding by the third day of admission, with persistent hypotonia and occasional irritability and arching. Shayla's course in the newborn nursery from date of admission (April 1, 1996) to date of discharge (April 29, 1996) is reasonably summarized in her resume, as follows: ADMISSION DIAGNOSES: Term female appropriate for gestational age 38 weeks. BO isommunization. Rule out sepsis. Feeding difficulties. Breech delivery. Floppy infant. DISCHARGE DIAGNOSES: Term female appropriate for gestational age. BO isoimmunization. Ruled out sepsis. Feeding difficulties improved. Breech delivery. Floppy infant, etiology unknown yet. PROCEDURES: 1. Lumbar puncture. Head CT scan. Video swallow test. EEG. HISTORY: This is a 38 weeks' AGA infant born from 18-year-old gravida 2, para 0-0-1-0 white female with prenatal care at Clinic C with 0 positive blood, hepatitis B surface antigen negative, HIV negative, RPR nonreactive, rubella immune, mother who has been positive for Chlamydia on 9/22/95 which later on became negative, several times UTI with Proteus mirabilis which was treated during pregnancy, otherwise unremarkable pregnancy. Breech presentation with less fetal movement according to mom. Rupture of membranes about 16 hours prior to delivery. Mom had chorioamnionitis, temperature of 100.6. She received antibiotics prior to delivery . . . . [Baby was born by SVD] Apgars reported at 3 and 8 secondary to hypotonia, low respiratory effort and color. Mom denied drugs, alcohol or cigarette smoking during pregnancy. Mother had one elective abortion at 9 weeks of pregnancy in 1994 with different father. Father is a black male who has not been involved after pregnancy. HOSPITAL COURSE: Baby had poor p.o. feeding on the third day of admission noticed, not improving her tone and mostly floppy with occasional irritability and arching. With initial prolonged rupture of membranes and mother's known history of chorio, blood cultures, CBC, urine and CIE were done, and the patient was started on antibiotics, ampicillin and gentamicin. On the third day due to poor feeds LP was done too, and continued antibiotics until 72 hours of negative cultures. The infant continued to be floppy with generalized hypotonia and occasional arching especially neck and back accompanied with opisthotonos and extension of extremities with irritability and inconsolable. This problem continued during the past 28 days of newborn nursery. Her hypotonia did not progress, and at the same time did not improve or improved a little bit. Her irritability and arching to some extent decreased. These days she is most of the time resting with less irritability but the problem of hypotonicity and lethargy continued. Problem #1. Fluids/electrolytes/nutrition: On the first three days of life she continued with the regular care with p.o. feeding. Initially it was decided by mom to breast- feed but since she was not eating enough or not sucking enough continued with bottle feeding, namely Enfamil with Iron, but on the third day it was noticed that she was not taking enough or not sucking enough, and at the same time was getting easily tired. It was decided to continue with p.o. and at the same time NG feeding but her feeding pattern did not improve and most of the time she was dependent on NG feeding due to decreased or insufficient sucking reflex and swallowing problem. Speech therapy was consulted. Video swallow was done which showed incoordination of the muscle, and at the same time although there was no frank aspiration but was high risk for aspiration. Continued NG feeding most of the time and with OT and physical therapy with speech therapy daily arrangement this problem somehow resolved. Accordingly, it has been about a week that the patient is eating by p.o. without any need for NG. The last video swallow which was done about a week ago, namely on 4/24 showed improved swallowing mechanism but still is at risk for aspiration. No aspiration was noticed during this test. Accordingly, she is taking about 75 cc Enfamil with Iron and rice cereal is added to it . . . for thickening and decreased risk for aspiration. Problem #2. Floppy baby, hypotonia, occasional arching and irritability: The patient was born with breech presentation with history of prenatal decreased fetal movement with Apgars of 3 and 8. She continued to be hypotonic which was not improving and occasional arching which was significant. Initially sepsis was ruled out including lumbar puncture done which was normal and antibiotics were discontinued based on negative cultures. CT scan of the head was done which was normal. Neurology consult was done from Nemours Children's Clinic. Dr. Shank followed this patient. Their impression was hypotonia that appeared to be prenatal due to breech presentation and decreased fetal movement. Dr. Shanks suspected that it is central due to fair muscular strength, but at the same time it was complicated by absence of deep tendon reflex. [Dr. Shank observed that the differential diagnosis was extensive (chromosome, metabolic, syndromic mostly likely)]. He suggested to do chromosomal workup, metabolic, and other syndromes which can cause the same hypotonia and his recommendation was followed. High resolution chromotrope was normal. Basic chemistry including sodium, potassium, calcium, phosphate, magnesium, liver function tests, and CPK were normal. Serum blood test was normal. Serum very long chain fatty acid was done which is followed by genetics, the result of the test is mentioned below. Urine metabolic screening was done too. Thyroid function was normal which was recommended also by neurology. EEG was done on 4/16/96. The patient had episodes of suspicious lip smacking. To rule out possibility of seizure EEG was done the same day which was normal. Ophthalmology consult was done on 4/10/96 to rule out possibly of some metabolic abnormalities, infectious, or other finding by routine lens evaluation. Ophthalmology examination was entirely normal at this time. The patient was also followed by DEI (developmental early intervention) and also by OT, PT and ST on the basis of p.r.n. Genetics: The patient was seen today by Dr. Perszyk from Nemours Children's Clinic after having all the metabolic screening and results from plasma amino acid, urine amino acid, urine organic acid and other tests . . . [At the time, Dr. Persyk's differential diagnosis included mitochodrial disease, lactic acidosis, or congenital myopathy (central core disease).] Problem #3. Social: Mom is an 18-year-old white female. Father is black but has not been involved. There is no history of any genetic abnormality, muscular disease, neurologic abnormality or seizures in the family on the maternal side. We do not know anything about the father's side. Mom had prenatal care . . . [at University Medical Center, Clinic C]. PHYSICAL EXAMINATION ON ADMISSION: Weight 2,915 g which is equal to 25-50th percentile, height 45.7 cm equal to 10th percentile, head circumference 34.5 cm equal to 75th percentile. On admission vital signs were stable. Pulse 150, respiratory rate 48, blood pressure 58/30. Generally she was described as pink and active without any facial dysmorphism. Eyes with red reflex without discharge. Ears no tags, no sinus, no external abnormality. Mouth without any cleft. Neurological exam has been described as symmetric muscle tone and active. PHYSICAL EXAMINATION ON DISCHARGE (DAY #28): Weight 3,181 g. She has been responsive to touch, pain, stimuli, but still has arching movements and opisthotonos but to a lesser extent. HEENT showed anterior fontanelle open and flat. Head circumference 36.5 cm. Positive red reflex. Pupils equal, round and reactive to light, but at this time is not focusing which is expected. Lungs clear to auscultation bilaterally. Cardiovascular with rate and rhythm regular without murmurs. Good peripheral pulses. Abdomen soft, no mass, no hepatosplenomegaly. Liver edge is palpable about 1.5 to 2 cm below right costal margin and it is soft. Genitourinary without any hip click. Extremities with generalized hypotonia but is moving with pain and stimuli. Neurological exam showed generalized hypotonia. She cannot move her head at all. She has some flexion of extremity but is purposeless. Mild grasp reflex. No deep tendon reflex. No clonus. Has good sucking reflexes but there is no rooting reflex. No Moro reflex. SIGNIFICANT LABORATORY FINDINGS: Baby is B positive, Coombs' positive. Mom is 0 positive. Blood culture negative. Chloric metabolites negative. Group B Strep urine negative. CSF result showed glucose of 38, protein 58, with 3 white blood cells. CSF culture negative. Total bilirubin increased to maximum 7.3 with direct of 0.2. Chem-20 was done on 4/11/96 which showed glucose of 45, sodium 134, potassium 4.1, chloride 99, BUN 6, creatinine 0.6, calcium 10, phosphorus 7.1, total protein 6.2, albumin 4, total bilirubin 2.1, SGOT 22.7, alkaline phosphatase 190, SGPT 14, triglycerides 154, uric acid 3.2, LDH 439, cholesterol 101, anion gap 12. Hematocrit 43.4, white blood cells 11.3. T4 16, TSH 1.97, CK 313. All of the above has been in normal range. Repeated Chem-20 on 4/15/96 showed glucose of 63, chemistry within normal limits, total protein 5.4, albumin 3.5, liver function tests within normal limits, hematocrit 46, LDH 306, cholesterol 91, anion gap 9, magnesium 2. Ammonia showed 41 and CK 193. Lactic acid 2.6. UA showed normal with pH of 6.5, with no ketones. Urine CMV was negative. [Her] stool pH was 7, no reduce in substance. IgM was done on 4/24/96 which was 30.6 and IgG was 832 which was within normal limits. PKU was normal. Galactosemia normal. Hemoglobin electrophoresis normal and 17-hydroxy was 27.2 which is within normal limits. A very long chain fatty acid showed mildly elevated on 4/26 which is 0.034. Creatinine was normal, free creatinine was normal too. Amino acid panel was done. A copy of the result is sent to genetics, Dr. Perszyk, and also a copy of the urine amino acid and urine organic acid - at this time not significant finding. Chest x-ray was done which was normal. IMPRESSION: In summary, this is a floppy child who was born at 38 weeks of gestation with AGA with history of breech presentation with no genetics or prenatal complication. Her floppiness did not progress, at the same time it did not improve significantly either. Metabolic screening was done which at this time is not significant and needs to be followed up with other clinical findings. Neurological abnormality could not be ruled out at this time and needs to be followed up by neurology. Her p.o. feeding improved. This patient never had any life-threatening event during the 28 days in newborn nursery. She has never been on any monitors. She is still at risk for aspiration, and we instructed the parent about the feeding; they are CPR trained. VNA nursing, OT, PT and speech therapy are following the case. Primary care doctor, Dr. Cedres, is aware of the situation, and the plan is to follow closely by genetics, neurology and primary care physician for further workup. FOLLOWUP: 1. Dr. Cedres . . . . He is the primary care physician . . . . Dr. Perszyk, Nemours Children's Clinic, Division of Genetics, in two weeks . . . . Dr. Shanks, Nemours Children's Clinic, Division of Neurology, for the followup of the patient's neurological evaluation, improvement or drugs. 4. EIP (early intervention program) for followup for occupational, physical and speech therapy . . . . Shayla's subsequent development Following her discharge from University Medical Center, the medical records reveal that Shayla was followed at Nemours Children's Clinic at least through July 28, 1998. There, Shayla was under the care of, among others, Daniel E. Shanks, M.D., a pediatric neurologist, and Anthony Perszyk, M.D., a pediatric geneticist, both of whom had consulted on her care at University Medical Center. Such continuum of care was initially directed toward establishing an etiology that would explain her hypotonia, manifest at birth (described as congenital) and failure to thrive (poor feeding), but later came to include a more complex symptomatology (including discoordination of movement, gastroesophageal reflux, developmental delay (motor and cognitive), absence of deep tendon reflexes, indifference to pain, and absence of tears) that slowly manifested. Over time, Shayla underwent extensive diagnostic evaluations, including genetic, metabolic, structural, and infectious disease testing, which failed to reveal any abnormality to explain her presentation, and on August 4, 1997, Dr. Shanks summarized his thoughts, as follows: IMPRESSION: Presumed static encephalopathy of unclear etiology in a youngster who has a number of somewhat unusual features for a typical cerebral palsy. Though she has central hypotonia, she is developing some increased tone distally but has reflexes that I cannot elicit. She seems to have a decrease in her sensory responsivity. The possibility of a congenital neuropathy in addition to her encephalopathy is raised. Additionally, concerns regarding possible high cord lesion cannot be excluded. Consequently, Dr. Shanks recommended that they obtain "a C-spine and brain MRI, as well as nerve conduction studies." The spinal MRI did not reveal any abnormality. The brain MRI, taken September 5, 1997, was read, as follows: Minimal squaring of the frontal horns can be defined with prominent ventricular system involving the lateral, third as well as fourth ventricles. Minimal increase in extraaxial fluid can also be demonstrated. These findings are nonspecific. The lateral ventricles are slightly asymmetric, more so on the right. These findings are nonspecific. A focal signal or structural abnormality cannot be demonstrated. The myelination pattern is within normal limits. Minimal increase in CSF volume can be seen in the posterior fossa, the finding should represent a giant cisterna magnum. Incidental finding of abnormal increase in T2 signal intensity in the ethmoid, as well as maxillary sinuses. Correlation with clinical findings would be helpful. The results of the MRI brain scan are consistent with periventricular leukomalacia (PVL) which, as an isolated finding, is nonspecific or, stated otherwise, not diagnostic. Of note, PVL, which demonstrates as "a tiny bit of scarring in the infant's ventricles," may be seen in infants who have suffered ischemic brain disease, as well as in normal term and pre-term infants. (Respondent's Exhibit 1, pages 26 and 27). More helpful to establishing an etiology for Shayla's neurologic presentation, the nerve conduction studies, performed November 19, 1997, demonstrated abnormalities consistent with a severe sensory neuropathy, likely the group HSAN (hereditary, sensory and autonomic neuropathy), also referred to as congenital sensorimotor neuropathy during the course of this proceeding. To confirm such impression, Dr. Shanks ordered a seral nerve biopsy, which was performed in January 1998, and unequivocally identified the presence of a neuropathic process, characterized by severe loss of myelinated fibers. On March 13, 1998, at the request of Dr. Shanks, Shayla was seen by David Hammond, M.D., Director of Neuromuscular and MDA Clinics, Nemours Children's Clinic. The results of that consultation were reported, as follows: I saw Shayla in consultation in neurology clinic at Nemours today as requested by her regular neurologist, Dr. Shanks. History was obtained from Shayla's mother and grandmother. CHIEF COMPLAINT: 23-month old with developmental delay and truncal hypotonia, etc. INTERIM HISTORY OF PRESENT ILLNESS: Very slow if any developmental advances. She is not yet sitting. Her language skills are behind for age although there has been no apparent plateau or regression. Family has noted unexplained fevers. Additionally, an apparent insensitivity to pain persists. The parents have noted no significant abnormalities in terms of sweating, lacrimation, GI changes or pallor or skin mottling. REVIEW OF SYSTEMS, MEDICAL HISTORY, FAMILY HISTORY, SOCIAL/DEVELOPMENTAL HISTORY: Data as detailed in Dr. Shanks' notes on 8/4/97 and previous. No family history of neuropathy. GENERAL EXAMINATION, HIGHER INTEGRATIVE FUNCTIONS, CRANIAL NERVES, SENSORY, MOTOR, REFLEXES, COORDINATION, GAIT: Data as detailed in Dr. Shanks' letter of 8/4/97 and previous except/with height 79.8 cm, weight 10 kg, head circumference 46.5 cm. She is irritable but appears otherwise appropriate in terms of her social interaction when calm. No expressive language detected in the course of the examination. She does appear to respond well to simple directions from parent or grandparent. Truncal tone is decreased. Her lower extremity tone which was felt to be increasing on previous exams is difficult to evaluate because of her resistance to examination today. Areflexia. No response to noxious stimuli. No tears are noted when she is irritable and crying. Cardiac exam shows no apparent murmurs and a regular rhythm with a rate (while irritable) of 120. Abdominal examination is benign. No tongue fasciculations. She has vigorous movements of each of the four extremities as she resists examination. She is unable to sit or stand independently. DATA REVIEWED: MRI of brain (9/97) minimal squaring of the frontal horns with prominent ventricular system involving lateral third as well as fourth ventricle. Minimal increase in extra-axial fluid. Posterior fossa findings suggestive of a giant cisterna magna. Nerve conduction EMG (11/97) compatible with electrophysiologically severe sensory neuropathy. R1 blink reflexes were not elicitable. Sensory nerve action potentials are absent throughout. Motor conduction studies normal. Sural nerve biopsy (1/98) severe decrease in density of myelinated fibers which is diffuse. An unequivocal neuropathic process is present characterized by severe loss of myelinated fibers. Consider congenital neuropathy. Other available medical records as summarized above. ASSESSMENT: Child with a number of problems. 1. Indifference to pain, truncal hypotonia, gross motor delay and areflexia. The clinical constellation and the laboratory data are consistent with the diagnosis of hereditary, sensory and autonomic neuropathy (HSAN). HSAN Type IV is generally distinguished from HSAN Type II based on the presence of more significant cognitive involvement and more severe anhydrosis. Given the history suggestive of language and cognitive delay and the history of unexplained fevers, HSAN Type IV appears somewhat more likely diagnosis in this case than HSAN Type II. 2. Suggestion of possible autonomic involvement related to #1 in terms of her unexplained fevers. Would also recommend screening for cardiac arrhythmia with an EKG. 3. At risk unrecognized trauma skin ulcerations, etc. related to her HSAN. 4. Cognitive delay, changes on MRI scan as outlined above, changes in tone which have been noted in the past. Question of possible encephalopathic components unrelated to her HSAN. Would defer to Dr. Shanks in term of further evaluation and recommendations in this regard. According to the medical records, Shayla's last consultation with Dr. Shanks was June 8, 1998, "for followup of her hereditary sensory autonomic neuropathy type IV most likely." Dr. Shanks' notes of that visit do not speak to an encephalopathic component unrelated to Shayla's HSAN, but conclude with his "Impression: Encephalopathy associated with hereditary sensory autonomic neuropathy."2 On May 22, 2000, Thayla was examined by Michael S. Duchowny, M.D., a pediatric neurologist associated with Miami Children's Hospital. The results of that neurologic evaluation were reported by Dr. Duchowny, as follows: I evaluated Shayla Adame on May 22, 2000. Shayla is a four year old developmentally delayed girl who is brought for an evaluation of development problems. HISTORY ACCORDING TO MRS. ADAME: Mrs. Adame began by explaining that Shayla has been diagnosed with hereditary sensory and autonomic neuropathy type . . . [IV]. In this regard she has a congenital absence of sensitivity to pain in conjunction with other abnormalities. Her lack of pain perception has caused her to scratch her eyes and she has already required a right eye corneal transplant due to trauma. This has been accentuated by Shayla's inability to generate tears and she appears to lack the ability to generate secretions in a generalized sense. The diagnosis of this rare disorder was made at Nemours Children's Clinic at age 2 years when Shayla had a seral nerve biopsy. The results are not available today. Shayla is developmentally delayed with regard to her language and tends to speak in single words, but occasionally puts several together to talk in phrases or sentences. Her hearing is said to be intact. She drools frequently and has been diagnosed with "cerebral palsy". She has a scoliosis and is fitted with a brace, but this is not present today. Shayla has suffered from intermittent muscle spasms and has had a total of 2 or 3 febrile seizures lifelong. She was hospitalized in March of this year for pneumonia and was sent home on cardiac monitoring. Shayla required a G-tube which was placed at a year of age. This was withdrawn at age 2 years and she is now able to sustain herself through oral intake. She had neuroimaging studies as a infant which apparently were normal. Shayla presently takes artificial tears, but is on no other medications. She receives various therapies which have been beneficial. There is a history of unexplained fever which appears to be related to environmental temperatures and she has had temperatures as high as 106 degrees. Shayla has pervasive absence of sweating and apparently is scheduled for a sweat test in the near term. She has also had tongue biting episodes with the right lateral border of her tongue sustaining a significant injury. FAMILY HISTORY: Shayla is an only child. Her father[']s whereabouts are unknown. There is no family history of sensory or motor neuropathy and no history of any neurodegenerative illnesses. PRE- AND PERINATAL HISTORY: Shayla was born at term by frank breech presentation at University Hospital. Her birth weight was 6- pounds, 6-ounces. She remained in the hospital for a total of 29 days. Shayla is not walking, although she can pull to a stand. Toilet training is "in process." * * * PHYSICAL EXAMINATION reveals an alert small child, but in proportion. Her weight is 27- pounds and height 27-inches. The head circumference measures 48.4 cm and the fontanelles are closed. There are no cranial asymmetries. Shayla has a large area of depigmentation on her right posterior lateral buttock region. There is an asymmetry of her eye with a skin tag linking the upper and lower lids on the right lateral aspect of her eye where she had the corneal transplant. A small traumatic cataract is noted in the left eye as well. There are thick callouses over the knees from crawling. She has multiple ulcerations of her toes and fingers where she has picked at sores to the point of thick soft tissue overgrowth. Shayla has only a few teeth and several stainless steel replacement caps. Multiple gingival abscissa are noted. There is a scoliosis convexed to the left. The cardiovascular, respiratory and abdominal examinations are normal. The healed G-tube scar is noted. The limbs appear warm and there are full and bounding periphereal pulses. NEUROLOGIC EXAMINATION reveals Shayla to have delayed language development. She speaks primarily in 1 or 2 word phrases with thick dysarthric speech that frequently required interpretation. Drooling is remarkably prominent. There is central gaze fixation with conjugate following movements. The pupils are 3 mm and react sluggishly to light. I was unable to visualize the fundi of either eye due to opachification. Shayla can clearly see objects in all visual spheres and tracks actively. There is no facial asymmetry. The tongue is moist and appears to be papillated with several traumatic lacerations on the lateral grooves. Motor examination reveals symmetric strength and bulk. The tone is slightly diminished throughout. There is generalized areflexia of both upper and lower extremities. Sensory examination reveals absence of withdrawal to painful pinching of all extremities. She does appear to feel however, although pain is not specifically perceived. Shayla sits with a stable balance and without head titubation, but can not stand without support. Neurovascular examination reveals no cervical, cranial or ocular bruits and no temperature or pulse asymmetries. In SUMMARY, Shayla's neurologic examination is consistent with type IV hereditary sensory and autonomic neuropathy, a rare disorder that is often associated with mental retardation. This disorder is likely to be genetic in origin, although direct linkage has not been established. The cause (etiology) and timing of Shayla's neurologic dysfunction To address the cause and timing of Shayla's neurologic dysfunction, the parties offered the medical records relating to Ms. Adame's antepartum and intrapartum course, as well as those associated with Shayla's birth and subsequent development. Portions of those records have been discussed supra, and further salient portions will be addressed infra. Additionally, Petitioner offered the deposition testimony of Paul R. Summers, M.D., an expert in obstetrics and gynecology, and Respondent offered the deposition testimony of Michael S. Duchowny, M.D., an expert in pediatric neurology, and Charles Kalstone, M.D., an expert in obstetrics and gynecology. The medical records and the testimony of the physicians offered by the parties have been carefully considered. So considered, it must be concluded that Shayla's neurologic dysfunction resulted from a Type IV hereditary, sensory and autonomic neuropathy (a congenital sensorimotor neuropathy) unassociated with any intrapartum injury, hypoxic or traumatic in nature.3 In reaching such conclusion, the evidence regarding the bleed Ms. Adame suffered the evening of March 30, 1996 (which Dr. Summers alone opined evidenced a partial placental abruption, with resultant hypoxic brain injury and serious neurologic damage) has not been overlooked; however, it is also noted that when Ms. Adame presented at University Medical Center at 12:15 p.m., and later at 7:42 p.m., March 31, 1996, fetal heart monitoring was reassuring for fetal wellbeing, and that monitoring throughout the course of labor evidenced no significant abnormalities. Moreover, Ms. Adame's labor was essentially normal, the second stage of labor was not protracted, and Shayla's delivery, including her head, was without apparent delay or other difficulty. Further, it is noted that on delivery, Shayla presented with hypotonia, a cord pH of 7.182 and a base excess of -4.5 (a result inconsistent with significant deficit in oxygenation), a normal five-minute Apgar, and no evidence of seizure activity in the immediate postnatal period. Finally, it is noted that by presentation, development, and a seral nerve biopsy, it has been demonstrated that Shayla's neurologic presentation is consistent with a Type IV hereditary, sensory and autonomic neuropathy, as opposed to any intrapartum injury. In sum, as observed by Drs. Duchowny and Kalstone, whose testimony is most consistent with the medical records and the observation of Shayla's treating physicians, the record does not evidence an acute event during labor and delivery as the cause of Shayla's neurologic impairment.4
Findings Of Fact Zoe was born on May 21, 2019, at St. Mary’s Medical Center, a hospital, in West Palm Beach, Florida. Zoe was a single gestation and her weight at birth exceeded 2,500 grams. As set forth in greater detail below, the unrefuted evidence establishes that Zoe did not sustain a “birth-related neurological injury,” as defined by section 766.302(2). Donald Willis, M.D., a board-certified obstetrician specializing in maternal-fetal medicine, was retained by Respondent to review the pertinent medical records of Zoya Jones and Zoe and opine as to whether Zoe sustained an injury to her brain or spinal cord caused by oxygen deprivation or mechanical injury that occurred during the course of labor, delivery, or resuscitation in the immediate post-delivery period in a hospital. In his report, dated September 14, 2020, Dr. Willis summarized his findings and opinions as follows: In summary, the mother presented in labor at term. There was no apparent fetal distress during labor. Spontaneous vaginal delivery resulted in a vigorous newborn with Apgar scores of 9/9. Newborn hospital course was complicated only by the somewhat confusing history for syphilis . . . The baby suffered a brain injury at some time remote from the CT scan at 2 months of age. The baby as not depressed at birth and the newborn hospital course was not complicated by multi- system organ failures. The brain injury does not appear to be birth related. * * * There was no apparent obstetrical event that resulted in loss of oxygen or mechanical trauma to the baby’s brain during labor, delivery or in the immediate post delivery period. In his supporting affidavit, Dr. Willis opines, to a reasonable degree of medical probability, that “there was no apparent obstetrical event that resulted in loss of oxygen or mechanical trauma to the baby’s brain or spinal cord during labor, delivery or in the immediate post-delivery period.” Respondent also retained Michael S. Duchowny, M.D., a pediatric neurologist, to review the medical records of Zoya Jones and Zoe, and to conduct an Independent Medical Examination (IME) of Zoe. The purpose of his review and IME was to determine whether Zoe suffered from a permanent and substantial mental and physical impairment as a result of an injury to the brain or spinal cord caused by oxygen deprivation or mechanical injury in the course of labor, delivery, or resuscitation in the immediate post- delivery period. Dr. Duchowny reviewed the pertinent medical records and, on October 15, 2020, conducted the IME remotely via Zoom teleconference. In his report, prepared November 6, 2020, he summarized his findings and opinions as follows: In summary, Zoe’s neurological evaluation reveals findings consistent with a substantial mental and motor impairment. She has spastic quadriplegic (double hemiparetic) cerebral palsy, oromotor incoordination, microcephaly, absence of receptive and expressive communication, sensorineural hearing loss in the left ear and pathologic developmental reflexes. Her level of development approximates that of a 3-6 month-old infant. Review of the medical records reveals that Zoe was born at 40 2/7 weeks gestation at St. Mary’s Hospital and weighed 6’12” [sic]. Pregnancy was complicated by several sexually transmitted diseases including a positive RPR that was treated with penicillin but secondarily increased near term. Pregnancy was also complicated by Type 2 HSV genital infection and trichomonas infection treated with metronidazole. Zoe was delivered vaginally with Apgar scores of 9 and 9 at 1 and 5 minutes. Cord blood gases were not requested and there was no evidence of systemic organ dysfunction. Zoe was discharged from the nursery on the third day of life. * * * Based on today’s neurological evaluation and medical records review, I believe that while Zoe’s neurological impairments and permanent and substantial, they were most likely acquired in utero. The records do not provide support for intrapartum oxygen deprivation or mechanical injury, and the brain imaging findings are more consistent with a prenatally-acquired infections process that affected the brain. For these reasons, I am not recommending that consideration be given for Zoe’s inclusion in the NICA program. In his supporting affidavit, Dr. Duchowny opines, to a reasonable degree of medical probability, that Zoe did not suffer an injury to the brain or spinal cord caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate post-delivery period which rendered her permanently and substantially mentally and physically impaired. The undisputed and unopposed findings and opinions of Drs. Willis and Duchowny are credited. The undersigned finds that Zoe did not sustain an injury to the brain or spinal cord caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate post-delivery period in a hospital, which rendered her permanently and substantially mentally and physical impaired.
The Issue The issue in this case is whether Ailani Sanchez suffered a birth-related injury as defined by section 766.302(2), Florida Statutes, for which compensation should be awarded under the Florida Birth-Related Neurological Injury Compensation Plan (the Plan).
Findings Of Fact Ailani Sanchez was born a live infant at 5:46 a.m., on October 29, 2015, at Lakeland Regional Medical Center. Ailani was a single gestation, weighing 2,950 grams at birth. Ailani was delivered via cesarean section for suspected abruption/velamentous insertion of cord by Dr. Zollicoffer who was a NICA participating physician on October 29, 2015. Ailani's Apgar scores were 2/4/4. Upon delivery, she was floppy and pale and had no respiratory effort. Pulse oximetry was within target saturations for age and her heart rate remained 100 or greater. She was intubated at seven minutes of age and transferred to the Neonatal Intensive Care Unit (NICU). No seizures were noted. Ailani had increasing spontaneous respiratory effort and whole body cooling was started prior to her transfer to St. Joseph's Hospital NICU on October 29, 2015. Upon admission to St. Joseph's Hospital on October 29, 2015, Ailani was lethargic with decreased reactions to stimuli, but appeared pink and well perfused. Neurologically, she was noted to be improving; she was breathing spontaneously and moving all extremities to stimuli. After a complicated newborn hospital course, Ailani was ultimately discharged from St. Joseph's Hospital on January 6, 2016. At the time of her discharge, she was noted to be feeding by mouth and was overall gaining weight. Prior to her discharge, an EEG on October 30, 2015, showed seizures predominantly on the right side of her brain and generalized brain dysfunction. A brain MRI obtained on November 5, 2015, revealed restricted diffusion related to acute infarction in the right temporal occipital region with laminar necrosis. Additional laminar necrosis in the frontal lobes and insular cortex bilaterally was noted. An EEG on November 16, 2015, was consistent with nonspecific cerebral dysfunction with occasional sharp waves in the temporal parietal regions bilaterally with no evidence of seizures and irregular slow waves with slightly more predominance to the right. Ailani was seen for a newborn visit by her pediatrician, Dr. Bou Salvador, on January 7, 2016. Nutritionally, she was noted to be breast feeding adequately, with supplements with formula. Developmentally, she was noted to have equal movements of all extremities and follow midline. She responded to a bell and was able to lift her head while lying on her stomach. Examination of her spine, extremities, and peripheral pulses were all normal. Neurologically, she was reportedly normal, with normal strength, tone, and reflexes reported. On January 19, 2016, Ailani was evaluated at All Children's Outpatient Care upon referral by St. Joseph's Hospital secondary to hypoxic ischemia. The occupational therapist's impression included decreased bilateral coordination, decreased developmental milestones, decreased gross motor skills, decreased play skills, decreased strength, and fine motor deficits. Skilled therapy was identified to have the potential to improve her functional level in the areas of manipulation. It was recommended that Ailani undergo 30 minutes of occupational therapy once a week for six months. Her prognosis for achieving goals established by her therapist was noted to be excellent. On February 4, 2016, Ailani was evaluated for participation in, and deemed eligible for, the Early Steps Program. On February 18, 2016, Ailani was evaluated by Dr. Qureshi at Kids Neurology. Developmentally, she was noted to smile and coo and focus. It was noted that Ailani had three seizures at the age of one day old, but none since. At this time, she was taking Keppra and Phenobarbital, from which she was being weaned. A sleep deprived EEG, obtained since the last visit, was normal. She was noted to be doing very well neurologically. Her physical examination revealed she was lifting her chest and head with her arms extended. Early head control with bobbing motion was noted. She was noted to say "aah," smile, and follow pass midline. The plan noted at this time was to continue to wean and discontinue Keppra and Phenobarbital. Ailani was again seen by Dr. Bou Salvador on March 4, 2016, for her four-month well visit. Nutritionally, she was noted to be feeding with formula adequately. She had been started on solids for one to two feeds. Developmentally, she was noted to squeal and laugh. She was able to follow 180 degrees. She turned to void and was able to hold her head up 90 degrees while lying on her stomach. She was able to sit with support with her head up. She was able to pull to sit with no head lag. She could bring her hands together and had no persistent fist clenching. Her physical examination was normal. Her neurological examination was also normal, with normal strength, tone, and reflexes reported. Ailani was again seen by Dr. Bou Salvador on May 4, 2016, for her six-month well visit. Nutritionally, she was noted to be breast feeding adequately. Developmentally, she was noted to be social and smiling responsively. Adaptive equal movements of all extremities and the ability to follow midline were noted. She could respond to a bell and was able to lift her head while lying on her stomach. A physical examination was normal. A neurological examination was also normal, with normal strength, tone, and reflexes reported. On May 24, 2016, Ailani returned to Dr. Qureshi at Kids Neurology. It was noted that Ailani had been weaned from her seizure medication and had had no seizures for the last three months. She was noted to be doing very well neurologically. Physically and developmentally, she was noted to have no head lag, to be rolling over, to have her chest up in a prone position, to be trying to crawl, to be lifting her head, and to be sitting briefly unsupported. She was also noted to be leaning forward on her hands, engaging in bounce activity, supporting most of her weight, reaching out and grasping large objects, transferring from hand to hand, babbling, enjoying mirror, and using polysyllable sounds. She was noted to be feeding herself. Dr. Qureshi reported that Ailani was in occupation therapy but that it was on hold since her evaluation was "pretty unremarkable." Ailani was noted to be progressing well for her age and was receiving Early Steps intervention once a week at home. She was given a prescription of Phenobarbital for use only if a seizure occurred. On June 18, 2016, Ailani was seen by Dr. Frances Arrillaga at Pediatric Cardiology Associates for a cardiology consultation secondary to a history of pulmonary hypertension, and an echocardiogram that showed a patent foramen ovale (PFO). Ailani's mother reported that since her discharge from St. Joseph's, she was doing well. Cyanosis, difficulty breathing and unexplained diaphoresis and feeding problems, were denied. An echocardiogram on this date showed a PFO, with otherwise normal anatomy. There were normal right ventricular (RV) pressures, normal left ventricular (LV) size and function. No cardiovascular restrictions were given and she was told to return in one year for further follow up. Ailani was again seen by Dr. Bou Salvador on August 4, 2016, for her nine-month well visit. Nutritionally, she was reported to be feeding adequately. She was feeding 2 to 3 varieties of solid foods with no problems and was starting with a cup for water and juice. Developmentally, she was reported to be playing pat-a-cake and looking for fallen objects. She could bang two cubes in her hand with thumb-finger grasp. She could say "dada" and "mama" and walk while holding on. She was also noted to be crawling and standing momentarily. Her physical and neurological examinations were noted to be normal, with normal strength, tone, and reflexes noted. An August 22, 2016, a progress note from Early Intervention reflects that Ailani was babbling two syllables together, was happy, pulling to a stand and cruising along furniture, and was responding to her name. Attendance at Early Intervention was noted to be consistent and once a week. Ailani was again seen by Dr. Bou Salvador on November 3, 2016, for her 12-month well visit. Nutritionally, she was noted to be eating two to three varieties of solid foods with no problems and was feeding herself finger foods. Developmentally, she was reported to be playing pat-a-cake and drinking from a cup. She was able to bang two cubes held in her hands with thumb-finger grasp. She was saying "mama" and "dada," imitated speech sounds, could say three words other than "mama" and "dada," and understood "no." She was able to walk while holding on, and was reported to stand alone and walk well. A physical examination revealed normal extremities. A neurologic examination was also normal, with normal strength, tone, and reflexes reported. On November 21, 2016, Ailani returned to Dr. Qureshi at Kids Neurology. It was noted that Ailani had been weaned off medications six months earlier and had no seizure activity since. She was noted to be doing very well. It was noted that no therapy was being provided at this time, although she was evaluated for occupational therapy but did not qualify for it. Developmentally, she was noted to be walking with one hand held, rising independently, taking several steps, getting to sitting, pulling to stand, standing for two seconds, saying a few words besides "mama" and "dada," playing ball game, making postural adjustment to dressing, waiving "bye bye," and indicating what she wants. She was noted to have pincer grasp, releasing objects to others when grabbed, and banging two things. Dr. Qureshi noted "she is doing amazing right now." A December 24, 2016, emergency room record (for a cough/choking episode after eating a piece of Dorito) from Florida Hospital Tampa reflects that Ailani had not had seizures since birth, and had been off Keppra and Phenobarbital for almost a year. A physical examination revealed an active, well- developed, and well-nourished child. Neurologically, she was noted to be awake, alert, and interacting with family and staff. She was also noted to be active and playful. An Early Intervention progress note from February 15, 2017, reflects Ailani had age-level play skills, could communicate using vocalizations and some single words, could follow routine directions, and was independent with walking and floor transfers. Good progress was noted to be made, many goals were reported met, and the parents decided to reduce services to one time per month. On January 30, 2017, Ailani was reevaluated for participation in Early Steps. It was noted that Ailani's mother had no concerns at this time. The report notes that Ailani liked the slide, liked to kick the ball, liked to play with her siblings and cousins, and that she is very curious. No hearing or vision concerns were noted. It was reported that many of her goals had been met, and that Ailani was using a variety of vowels and consonants, identifying at least three family members when named, that she was saying a variety of words, and was using a sign for "more food." Ailani was noted to still be eligible for Early Steps secondary to her diagnosis of hypoxic ischemic encephalopathy. Ailani was seen by Dr. Bou Salvador on March 28, 2017, for her 16-month well visit. She was noted to have good eating habits and a good appetite. No mealtime problems were reported, and she was noted to be eating solid foods with no problems. She was noted to have socially appropriate behavior for her age. She was talking well and was able to balance on one foot for five seconds, could throw a ball overhead, and pedal a tricycle. Her orthopedic and neurologic examinations were normal, with normal strength, tone, and reflexes reported. At the request of NICA, Donald C. Willis, M.D., who specializes in obstetrics and gynecology and maternal-fetal medicine, reviewed the medical records included in the Stipulated Record as Joint Exhibits A through G. In his report dated August 2, 2017, which was admitted into evidence without objection, Dr. Willis noted in pertinent part that Ailani's mother was cramping when she presented to the hospital, and was three centimeters dilated with suspected amniotic membranes ruptured. Contractions were noted to be occurring occasionally. Medical records indicated the presence of late decelerations on admission, which progressed to bradycardia, for which an immediate Cesarean section was recommended. Dr. Willis observed that Ailani was depressed at birth with Apgar scores of 2/4/4, and that cord blood gas was abnormal with a pH of only 6.97. He further noted that Ailani was floppy, pale, and had poor perfusion; that bag and mask ventilation was initiated, followed by intubation for continued respiratory distress; that hypotension was present and required IV fluids; that the initial blood count was low; and that Ailani remained acidotic after birth with a pH of 6.7 and a base excess of -27 at 90 minutes after birth. Dr. Willis further noted Ailani's hospital course consistent with her medical records and ultimately opined that “there was an obstetrical event that resulted in loss of oxygen to the baby's brain during labor, delivery and continuing into the immediate post delivery period. The oxygen deprivation resulted in brain injury.” Dr. Willis was unable to comment about the severity of the injury, however. At the request of NICA, Laufey Y. Sigurdardottir, M.D., who is board certified in neurology and specializing in pediatric neurology, reviewed the medical records included in the Stipulated Record as Joint Exhibits A through G, and performed a thorough examination of Ailani on October 18, 2017. Dr. Sigurdardottir's summary of Ailani's medical history, along with her findings upon a full physical and neurological examination, is documented within her written report, which was admitted into evidence without objection. Dr. Sigurdardottir noted that Ailani was a non-dysmorphic, interactive toddler with normal facial features and apparently intact vision. No abnormalities in Ailani's extremities were noted other than occasional toe walking. Neurologically, Ailani was noted to be interactive, curious, and exhibiting normal joint attention. Ailani exhibited pretend play with a stethoscope, said the word "mom" a few times, pointed to her mouth when asked to do so, enjoyed playing with a tablet computer, shook her head for "no," exhibited understandable words, and exhibited no autistic features. Cranial nerves were intact, facial grimacing was symmetric and normal, and hearing seemed intact. No drooling was noted. Muscle tone was noted to be normal, strength was full and symmetric and deep tendon reflexes were symmetric and within normal limits. Gross and fine motor skills were noted to be within normal limits for age. Overall, Dr. Sigurdardottir determined that despite her initial abnormal neurological examination, and delays in early development, Ailani's current neurologic and developmental functioning is age-appropriate. She went on to opine in relevant part that, Ailani is not found to have substantial delays in motor and mental abilities at this time . . . . In review of available documents, there is evidence of impairment consistent with a neurologic injury to the brain or spinal cord acquired due to oxygen deprivation . . . . The prognosis for full motor and mental recovery is excellent and the life expectancy is full In light of evidence presented I believe Ailani does not fulfill criteria of a substantial mental and physical impairment at this time. I do not feel that Ailani should be included in the NICA program. Neither Petitioner nor Intervenor submitted or introduced into evidence any expert reports rebutting the opinions of Dr. Willis and/or Dr. Sigurdardottir.
The Issue At issue in this proceeding is whether Thalya Greene, a minor, suffered an injury for which compensation should be awarded under the Florida Birth-Related Neurological Injury Compensation Plan.
Findings Of Fact Fundamental findings Daniel Greene and Lizbeth Greene, are the parents and natural guardians of Thalya Greene (Thalya), a minor. Thalya was born a live infant on August 27, 1998, at Baptist Medical Center, a hospital located in Jacksonville, Florida, and her birth weight was in excess of 2,500 grams. The physician providing obstetrical services during Thalya's birth was R. William Quinlan, M.D., who was, at all times material hereto, a participating physician in the Florida Birth-Related Neurological Injury Compensation Plan, as defined by Section 766.302(7), Florida Statutes. Thalya's birth At or about 4:35 a.m., August 27, 1998, Mrs. Greene (with an estimated date of confinement of September 19, 1998, and the fetus at 36+ weeks) presented to Baptist Medical Center in early labor. Vaginal examination revealed the membranes to be intact, and the cervix at 3 centimeters dilatation, effacement at 50 percent, and the fetus at station -2. External fetal monitoring applied at 4:37 a.m., reflected a reassuring fetal heart tone, and Mrs. Greene was admitted to labor and delivery at or about 4:40 a.m. Mrs. Greene's labor progressed steadily, and external fetal monitoring reflected a reassuring fetal heart tone throughout the course of labor and delivery. At or about 7:30 a.m., dilatation was noted as complete; at 7:49 a.m., the membranes were artificially ruptured, with clear fluid noted; and at 7:55 a.m. Thalya was delivered spontaneously (cephalic presentation) without incident. On delivery, Thalya was noted as "pale blue" in color, and was bulb suctioned and accorded free flow oxygen; however, she breathed spontaneously, and did not require resuscitation. Initial newborn assessment noted no apparent abnormalities. Apgar scores were recorded as 7 at one minute and 8 at five minutes. The Apgar scores assigned to Thalya are a numerical expression of the condition of a newborn infant, and reflect the sum points gained on assessment of heart rate, respiratory effort, muscle tone, reflex irritability, and color, with each category being assigned a score ranging from the lowest score of 0 through a maximum score of 2. As noted, at one minute, Thalya's Apgar score totaled 7, with heart rate, muscle tone, and reflect irritability being graded at 2 each; respiratory effort being graded at 1; and color being graded at 0. At five minutes, Thalya's Apgar score totaled 8, with heart rate, respiratory effort, muscle tone, and reflex irritability being graded at 2 each, and color again being graded at 0. Thalya was admitted to the newborn nursery at or about 8:50 a.m. Assessment on admission was grossly normal. Thalya's status post-delivery was uneventful until 11:30 a.m. (approximately 3 1/2 hours after delivery) when she experienced a choking episode (secondary to spitting up) and turned dusky over the face and chest. In response, Thalya was placed under a radiant warmer, suctioned, and given blow by oxygen (for approximately 3 minutes) until she pinked up. Thereafter, Thalya's course was again uneventful until 1:00 a.m., August 28, 1998, when she again appeared dusky, and was accorded blow by oxygen. At the time, it was noted that the CBC drawn during the first dusky spell was within normal limits and that the blood culture that had been obtained was preliminarily negative. Thereafter, Thalya's course was again without apparent complication until approximately 10:23 p.m., when she "became dusky not associated with feed," and was again suctioned and accorded blow by oxygen. At that time, Thalya was noted as "pink and intermittently tachypneic with rare grunting." Following neurologic consult, Thalya was transferred to the neonatal intensive care unit (NICU) for further observation and management. Thalya was received in the NICU at 10:34 p.m. At the time, she was observed as "warm and pink with grunting noted." EKG leads were applied and revealed a heart rate of 180, respiratory rate of 50, blood pressure of 76/49, and a rectal temperature of 100.3. Examination revealed nystagmus (an involuntary rapid movement of the eyeball) and some jerky movements of her extremities. CBC showed a white blood count of 5,000, and blood culture was ordered. Working diagnosis was "suspected septis" and Thalya was started on ampicillin and gentamicin. At 12:35 a.m., August 29, 1998, Thalya evidenced symptoms of seizure activity, and was loaded with phenobarbital. Spinal tap of August 29, 1998, as well as the results of the blood culture drawn of August 28, 1998, was positive for Group B Streptococcus. An infectious disease consult was obtained and Thalya was managed on antibiotics for three weeks, and maintained on phenobarbital for her seizure activity. CT and MRI of the head on August 29, 1998, were normal; however, a head ultrasound of September 3, 1998, showed minimal intra-axial fluid. Chromosomal studies were normal. Thalya was discharged to her parents' care on September 15, 1998, on phenobarbital and ampicillin. Final diagnosis on discharge included bacterial infection due to Streptococcus, Group B; streptococcal meningitis; and seizures. Thalya's subsequent development Following her discharge from Baptist Medical Center, Thalya was initially followed by Carlos H. Gama, M.D., a pediatric neurologist. Dr. Gama's first neurological examination occurred on November 3, 1998, when Thalya was 2 months of age, and was reported as follows: I had the opportunity of seeing Thalya for a neurological evaluation. The following are my diagnosis and recommendations. Diagnosis: Status post neonatal Group B Streptococcal meningitis. Seizures. Hypotnia. Recommendations: Obtain EEG. Obtain trough Phenobarbital level. Obtain records. Return to this office in one month for reevaluation and further recommendations. Comments: * * * . . . Since discharged from NICU mother reports that Thalya had done well. She is feeding well and thriving. No seizures have been noted. She continues on Phenobarbital, taking 4mls po bid. A blood level was obtained prior to this visit but this result is not available. Mother reports that Thalya has normal awake and sleep cycles. She seems to be moving all extremities spontaneously and symmetrically. There has not been any apneic spells or unusual behaviors suggestive of seizure like activity . . . . The examination today reveals a head circumference is 40.5cm (in the 90th percentile). Her weight is in the 90th percentile and height is in the 50th percentile. The baby is alert. She is able to turn her eyes to light, but does not track the examiner in a 90 degree range. The pupils were equal and reactive. Red reflex was present bilaterally. Facial grimace was symmetric. Suck was appropriate. Strength seems to be grossly unremarkable. Deep tendon reflexes were +2 in the upper extremities, +3 in the lower extremities at the knees and +2 at the ankles. No clonus was seen. Babinski's were present bilaterally. There was evidence of hypotonia of her axial musculature, being approximately moderate in severity. There was also decrease in head control. The patient's moro reflex reveals appropriate abduction of her upper extremities symmetrically. Traction response was decreased. Tone and neck reflex was absent. Palmar and Plantar reflexes were present. Muscle tone was low. The sensory examination to touch seemed to be unremarkable. Spine examination was noncontributory. The patient has no obvious dysmorphic features, organomegalies or skin abnormalities. Anterior fontanel was open and normal tense with no musculatures. Therefore, it is my opinion that Thalya has a history of neonatal Group B Streptococcal meningitis and sepsis associated with seizures. She is now seizure free. Her examination is remarkable for hypotonia, which most likely is on central basis. Therefore, the above recommendations were made. She will be reassessed in one month in this office. The EEG (Electroencephalogram) recommended by Dr. Gama was obtained on November 9, 1998, and read as abnormal. Specifically, the EEG report noted: This EEG is abnormal because of mild background disorganization which was seen bilaterally but more prominently over the right hemisphere, especially in the frontal region. This finding suggest[s] a diffused cerebral dysfunction such as seen in mild encephalopathy. In addition, a structural lesion in the right hemisphere cannot be excluded. Thalya was next seen by Dr. Gama on December 7, 1998. The results of that examination were reported as follows: Diagnosis: Seizure disorder. Stable on Phenobarbital. S/P [status post] Bacterial Group B Streptococcal Meningitis. Hypotonia. Developmental delay. Abnormal EEG. * * * Comments: . . . Thalya continues to be active. She is feeding well and gaining weight properly. She is making more cooing sounds and attempting to roll over, but she has not been successful in this area. Her examination demonstrates that her head circumference is 42cm. She is alert. She follows the examiner. Her pupils are equal and reactive. Face is unremarkable. She does seem to stick her tongue out intermittently. The motor examination demonstrates that she has decrease traction and head control for her age. She also has a tendency to keep her hands fisted, but this is only intermittently. She does not reach for objects yet. She is unable to hold weight in her lower extremities. Muscle tone seems to be slightly decreased in the axial musculature in particular. Therefore, it is my recommendation that we proceed with an MRI of the brain to rule out structural abnormalities of the right hemisphere.1 In addition, we have discussed the treatment with Phenobarbital. This should be continued for at least six months before making any further recommendations . . . She will be reassessed in this office in 1-2 months. Dr. Gama's next neurological examination of Thalya occurred on January 12, 1999, and was reported as follows: Diagnosis: Seizure disorder. Stable on Phenobarbital. S/P bacterial group B streptococcal meningitis. Hypotonia. Improving. Borderline developmental delay. Abnormal EEG * * * Comments: Thalya is doing extremely well. She is getting physical therapy twice a week and making progress. She is more attentive. She follows the examiner in a 180 degree range. She has good social skills. Anterior fontanel is soft. Head circumference is 44cm which is slightly above the 90th percentile, but she has been growing parallel to this with no problems. Cranial nerve examination is unremarkable. Motor examination demonstrates that she is unable to put weight in lower extremities, otherwise, she moves all extremities spontaneously. Deep tendon reflexes were unremarkable. No obvious pathological reflexes were elicited during today's visit. Muscle tone was normal to low. Denver Developmental Screen test reveals that she seems to be appropriate for her age in most of the areas. However, she is unable to roll over but she is showing some attempts to do this. The rest of the examination was noncontributory. Thalya was last seen by Dr. Gama on April 29, 1999, and he reported the results of that follow-up neurological examination as follows: Diagnosis: Seizure disorder. Stable on Phenobarbital. S/P Bacterial Group B Streptococcal Meningitis. Hypotonia. Improved. Comments: Thalya continues to do extremely well, with no recurrent seizures. She is tolerating the medication properly . . . . The patient continues to make progress in her development. The examination today demonstrates that her head circumference is 46.7cm. She is maintaining this in the 90th percentile. She has no obvious focal or lateralizing deficits. Her muscle tone has improved considerably and she is gaining milestones appropriately. She was felt to be at her age level in most of the areas tested . . . . Thalya's subsequent neurologic development was followed by Joseph A. Cimino, M.D., a board-certified pediatric neurologist. Dr. Cimino reported the results of his first neurological examination by October 15, 1999, as follows: DIAGNOSES: 1) GBS meningitis/sepsis. Neonatal seizures. Static encephalopathy with motor and language delay. * * * DEVELOPMENTAL HISTORY: The history is obtained from the parents. The child rolled from front to back at 7 months, back to front at 8 months, sat at 7 to 8 months, crawled at 11 months. She was getting in to sitting at 10 to 11 months, pulled to stand at 12 months, began to cruise at 13 months, is not yet walking independently, says mama but not specifically, does not say dada nor does she wave hi or bye. She began physical therapy at 3 months of age and this was initially twice a week and 1 month ago was decreased to once a week. She is not in speech therapy, although the family states the EIP evaluation at 10 months showed she had a receptive language at 4 months. The concern is that audiological evaluation have shown some missed frequency hearing deficit. * * * PHYSICAL EXAMINATION: The head circumference is 48 1/4 cms which is between the 75th and 98th percentile for chronologic age of 14 months. GENERAL EXAM: On inspection this is a well- nourished, healthy youngster who is alert and attentive. The abdomen was soft and nontender without organomegaly. The cardiovascular exam revealed regular rate and rhythm and no murmurs were appreciated. No cranial bruits are noted. The extremities were normal. The lungs were clear to auscultation. The skin exam was without café au lait spots or hypopigmented macules. The spine was without hair tufts or dimpling. In observing this child crawl and again reaching for objects I did not see any focality, nothing to suggest an old infarction which may be a complication of neonatal bacterial meningitis. In addition a CT scan was reported as negative. NEUROLOGICAL EXAM: The child is very social and attentive with good reciprocal play with a puppet. She smiled quite easily. Although with hands-on evaluation she did become irritable and cried. Assessment of tone was quite difficult. She tracked very nicely with full extraocular movements no ophthalmoparesis or nystagmus. The pupils were equal and reactive to light and facial movements were symmetric. I was not able to get an adequate look at the fundi. Corneal reflexes were intact. With regards to the motor exam, she reached quite nicely for objects without preference. She in fact did crawl well, transitioned into a sitting position but did W sit, usually associated with low muscle tone. With hands-on exam it was very difficult as she was crying and had a lot of active resistance to know exactly the status of her tone. She pulls to stand with a mature pattern with hip flexion. She sat quite nicely with her back straight, able manipulate objects. She did not slip through my grip on vertical suspension. Her deep tendon reflexes were 2/4 and symmetric in both the upper and lower extremities. The sensory exam was grossly intact to pain. IMPRESSION: GBS meningitis/sepsis . . . early onset. Neonatal seizure without recurrence, successfully tapered off of Phenobarbital. Prematurity 36 weeks gestation. Language delay. I think at 13 months adjusted age she should be saying mama and dada specifically, have more jargoning, waving hi and bye, and say several other words in addition to mama and dada which are used specifically. There is clearly risk of hearing deficit given meningitis and the use of Gentamicin and this child needs to be followed closely. History of motor delay. Clearly rolling at 6 months adjusted age is delayed. Sitting at 6 to 7 months adjusted age is normal, the family gave a chronologic age of 7 to 8 months but at 36 weeks gestation it is fair to make a 1 month adjustment which I am assuming they would do at EIP. She began to cruise at 13 months chronologic age which is 1 year. Her adjusted age is now 13 months and clearly walking independently can be normal up to 18 months at the outside limits. She appears to be making nice improvement in this area . . . . Thalya was next seen by Dr. Cimino on May 1, 2000, and most recently on November 10, 2000. Dr. Cimino reported the results of his most recent follow-up examination as follows: DIAGNOSES: 1) GBS meningitis. Neonatal seizures. Prematurity 36 weeks gestation Language delay. CLINICAL HISTORY: This is a 2 year old female seen in follow up on 5/1/2000. At that time she was having episodes of spacing out. We obtained an EEG that was normal for the awake and sleep state. Because of the GBS meningitis and developmental delay we obtained an MRI also done in September that was normal. She underwent a speech evaluation on 6/23/2000 that showed auditory comprehension at 9-12 months, verbal expression at 6-9 months. Impression was overall global delay and she has been in speech therapy twice a week at Brook's Rehab. Her chronologic age at the time of the evaluation was 22 months. At this time she began to walk at 15 months. She says mama and specifically, dada non- specifically. She will repeat words but does not have a lot of spontaneous words. She does wave hi and bye. PHYSICAL EXAMINATION: The head circumference is 50 1/4 cms which is between the 75th and 98th percentile. This continues to grow at the same rate. She is crying and extremely uncooperative. She is very frightened by many of her past appointments. She did track, had full extraocular movements without nystagmus or ophthalmoparesis. Her facial movements do appear sysmetric. Tone is low even with her resisting. She ran to her mother, I did not see any abnormalities. Her gait certainly was not wide based. She seemed to get off the floor well. Her sensory exam was grossly intact to pain. The deep tendon reflexes were difficult due to her withdrawal. IMPRESSION: Status-post Group B strep neonatal meningitis with neonatal seizure without recurrence. Language delay. Most likely reflecting sequela of the meningitis. There is a good percentage of these children who do have severe deficits. However, the EEG and MRI did not show any abnormalities. There is no slowing of the background activity and no decrease or delay in myelination reported on the MRI. PLAN: . . . Continue speech therapy . . . Reassess in 6 months. The cause of Thalya's neurologic dysfunction Regarding the cause of Thalya's neurological dysfunction, the proof is compelling that during labor and delivery Mrs. Greene was vaginally infected with Group B Streptococcal (GBS), that during delivery the infection was transmitted to Thalya, and that over the next 24 to 48 hours the infection process rapidly progressed causing meningitis and the resultant brain injury. Consequently, it may be said that Thalya's neurologic dysfunction is associated with a brain injury caused by meningitis (an inflammation of the membranes that envelop the brain and spinal cord), secondary to a GBS infection acquired during the birthing process (most likely subsequent to rupture of the membranes and during the course of delivery). The dispute regarding compensability As a touchstone to resolving the dispute regarding compensability, it is worthy of note that the Plan establishes a no-fault administrative system that provides compensation for an infant who suffers a narrowly defined "birth-related neurological injury." Under the Plan, a "birth-related neurological injury" is defined as: [I]njury to the brain or spinal cord of a live infant weighing at least 2,500 grams at birth caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate post-delivery period in a hospital, which renders the infant permanently and substantially mentally and physically impaired. Section 766.302(2), Florida Statutes. Here, there is no serious dispute that Thalya is neurologically impaired or that such impairment is attributable to a brain injury caused by the infection process discussed infra. Rather, what is at issue is whether the cause of Thalya's brain injury and the nature of her impairment fit the narrowly defined term "birth-related neurological injury." In this regard, it is Intervenor's view that Thalya's brain injury (occasioned by an infectious process) may reasonably be described as having been "caused by mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate post-delivery period," and that such injury rendered her "permanently and substantially mentally and physically impaired." Conversely, Petitioners and Respondent are of the view that that the cause of Thalya's brain injury was not a "mechanical injury," and that she was not rendered "permanently and substantially mentally and physically impaired." Of the two, Petitioners' and Respondent's view is by far the more compelling. The nature and timing of Thalya's injury To address the nature and timing of Thalya's injury, the parties offered the opinions of three physicians: Charles Kalstone, M.D., a physician board-certified in obstetrics and gynecology; Joseph Cimino, M.D., a physician board-certified in pediatric neurology; and James Perry, M.D., a Fellow of the American Academy of Neurology. (Joint Exhibits 2-4). Notably, these physicians shared strikingly similar views, and were of the opinion that Thalya's brain injury was caused by infection induced meningitis, a process distinguishable from an injury caused by oxygen deprivation or mechanical injury. Stated otherwise, the physicians were of the opinion that Thalya's injury could not reasonably be described as having been caused by oxygen deprivation or mechanical injury.2 Given the plain and ordinary meaning of the words used in the term "mechanical injury" (as physical harm or damage caused by machinery, tools, or physical forces), their conclusion was most reasonable.3 Consequently, it is resolved that Thalya's brain injury was not caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate post-delivery period. Thalya's current mental and physical presentation At hearing, the only authoritative proof offered with regard to Thalya's current mental and physical presentation was the testimony of Dr. Cimino, Thalya's pediatric neurologist. It was Dr. Cimino's opinion that while Thalya may evidence substantial cognitive impairment, she does not evidence substantial physical impairment. Such opinions are grossly consistent with the record and are credited.
Findings Of Fact Adam was born on June 11, 2018, at HealthPark Medical Center, in Fort Myers, Florida. Adam was a single gestation and his weight at birth exceeded 2500 grams. Obstetrical services were delivered by a participating physician, Jane A. Daniel, M.D., in the course of labor, delivery, or resuscitation in the immediate post-delivery period in a hospital, HealthPark Medical Center. As set forth in greater detail below, the unrefuted evidence establishes that Adam did not sustain a “birth-related neurological injury,” as defined by section 766.302(2). Donald Willis, M.D., a board-certified obstetrician specializing in maternal-fetal medicine, was retained by Respondent to review the pertinent medical records of Ms. Johnson and Adam and opine as to whether Adam sustained an injury to his brain or spinal cord caused by oxygen deprivation or mechanical injury that occurred during the course of labor, delivery, or resuscitation in the immediate post-delivery period in a hospital. In his affidavit, dated December 11, 2020, Dr. Willis summarized his opinions as follows: In summary, an abnormal FHR pattern developed during labor and resulted in a depressed newborn. Cord blood pH was 6.9 with a base excess of -18.6. Seizures began shortly after birth. The newborn hospital course was complicated by multi-system organ failures, consistent with birth-related oxygen deprivation. MRI on DOL 4 was suggestive of HIE, but findings improved with follow-up MRI. There was an apparent obstetrical event that resulted in oxygen deprivation to the brain during labor, delivery and continuing into the immediate post-delivery period. The oxygen deprivation resulted [in] a potential for brain injury, but the follow-up normal MRI suggests that no actual brain injury occurred. Respondent also retained Michael S. Duchowny, M.D., a pediatric neurologist, to review the medical records of Ms. Johnson and Adam, and to conduct an Independent Medical Examination (IME) of Adam. The purpose of his review and IME was to determine whether Adam suffered from a permanent and substantial mental and physical impairment as a result of an injury to the brain or spinal cord caused by oxygen deprivation or mechanical injury in the course of labor, delivery, or resuscitation in the immediate post- delivery period. Dr. Duchowny reviewed the pertinent medical records and, on October 20, 2020, conducted the IME. In his affidavit, dated December 16, 2020, Dr. Duchowny summarized his opinions as follows: In summary, Adam’s evaluation reveals findings consistent with a substantial motor but not mental impairment. He evidences a spastic diplegia, but with relative preservation of motor milestones, and age-appropriate receptive and expressive communication. Adam additionally has a severe behavior disorder, and has a sleep disorder and attentional impairment. His seizures are in remission. Review of the medical records reveals that Adam was the product of a 40 week gestation and was delivered vaginally with Apgar scores of 3, 6, 7 and 6 at one, five and 10 minutes. Terminal meconium was noted at delivery. Adam initially required positive pressure ventilation until his respirations were subsequently managed with nasal CPAP. His cord gas pH was 6.917 with a base excess of – 18.6. Adam developed seizures in the NICU and was intubated on the first day of life for apnea. Multiple seizures were documented on video/EEG monitoring. He was oliguric on the first day of life and had elevated liver function studies. An elevated lactic acid level was noted and there was a borderline elevation of DIC parameters. Adam was enrolled in a body hypothermia protocol on the first day of life. His blood pressure was maintained with dopamine. A head ultrasound on June 11 at 22:23 (DOL#2) was unremarkable. A brain MR imaging study performed on June 15, (DOL#5) revealed multifocal areas of restricted diffusion. Follow-up brain MR imaging study on July 5th revealed near-complete resolution of the previously observed diffusion abnormalities. A third MR imaging study obtained one month ago confirms the resolution of the DWI findings noted on the first brain MR imaging study. In conclusion, Dr. Duchowny opined that Adam does not have a substantial mental impairment, and, therefore, did not recommend that Adam be considered for inclusion in the Plan. The undisputed findings and opinions of Drs. Willis and Duchowny are credited. The undersigned finds that Adam did not sustain an injury to the brain or spinal cord caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate post-delivery period in a hospital, which rendered him permanently and substantially mentally and physical impaired.
