STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

SHEILA ADAME, as parent and natural ) guardian of SHAYLA ADAME, a minor, )

)

Petitioner, )

)

vs. ) Case No. 00-1437N

) FLORIDA BIRTH-RELATED NEUROLOGICAL ) INJURY COMPENSATION ASSOCIATION, )

)

Respondent. )

)

FINAL ORDER

Pursuant to notice, the Division of Administrative Hearings, by Administrative Law Judge William J. Kendrick, held a final hearing in the above-styled case on August 28, 2001, by video teleconference, with sites in Tallahassee and Miami, Florida.

APPEARANCES

For Petitioner: Robert E. Schack, Esquire

Law Offices of Gunion & Schack 9350 South Dixie Highway Miami, Florida 33156

For Respondent: W. Douglas Moody, Jr., Esquire

McFarlain & Cassedy, P.A.

215 South Monroe Street, Suite 600 Tallahassee, Florida 32301

STATEMENT OF 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.

PRELIMINARY STATEMENT

On April 5, 2000, Petitioner, Sheila Adame, as mother and natural guardian of Shayla Adame (Shayla), a minor, filed a petition (claim) with the Division of Administrative Hearings (DOAH) for compensation under the Florida Birth-Related Neurological Injury Compensation Plan (Plan).

DOAH served the Florida Birth-Related Neurological Injury Compensation Association (NICA) with a copy of the claim on

April 6, 2000. NICA reviewed the claim and on June 8, 2000, gave notice that it had "determined that such claim is not a 'birth- related neurological injury' within the meaning of Section 766.302(2), Florida Statutes," and requested that "an order [be entered] setting a hearing in this cause [on such issue]." Such a hearing was held on August 28, 2001.

At hearing, the parties stipulated to the factual matters set forth in paragraphs 1 and 2 of the Findings of Fact.

Petitioner's Exhibit 1 (the medical records filed with DOAH on April 5, 2000) and Petitioner's Exhibit 2 (the deposition of

Paul R. Summers, M.D., filed with DOAH on September 14, 2001), as well as Respondent's Exhibit 1 (the deposition of

Michael Duchowny, M.D., filed with DOAH on October 11, 2001) and Respondent's Exhibit 2 (the deposition of Charles Kalstone, M.D., filed with DOAH on September 6, 2001), were received into

evidence. No witnesses were called, and no further exhibits were offered.

The transcript of the hearing was filed October 11, 2001, and the parties were accorded 10 days from that date to file proposed final orders. No party elected to file such a proposal.

FINDINGS OF FACT

Fundamental findings

1. 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.

2. 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

   
   

3. 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

4. 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.

   
   

5. 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.

   
   

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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:

    
    

    1. Term female appropriate for gestational age 38 weeks.

    2. BO isommunization.

    3. Rule out sepsis.

    4. Feeding difficulties.

    5. Breech delivery.

    6. Floppy infant.

       
       

       DISCHARGE DIAGNOSES:

       
       

       1. Term female appropriate for gestational age.

       2. BO isoimmunization.

       3. Ruled out sepsis.

       4. Feeding difficulties improved.

       5. Breech delivery.

       6. Floppy infant, etiology unknown yet.

          PROCEDURES: 1. Lumbar puncture.

          1. Head CT scan.

          2. Video swallow test.

          3. 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 . . . .

       1. Dr. Perszyk, Nemours Children's Clinic, Division of Genetics, in two weeks . . . .

       2. 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

       
       

14. 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.

15. 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."

16. 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.

    
    

17. 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.

18. 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.

    
    

19. 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

20. 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

    
    

21. 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.

22. 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

23. 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

    CONCLUSIONS OF LAW

    
    

24. The Division of Administrative Hearings has jurisdiction over the parties to, and the subject matter of, this proceeding. Section 766.301, et seq., Florida Statutes.

25. The Florida Birth-Related Neurological Injury Compensation Plan (the "Plan") was established by the Legislature "for the purpose of providing compensation, irrespective of fault, for birth-related neurological injury claims" relating to births occurring on or after January 1, 1989. Section 766.303(1), Florida Statutes.

26. The injured "infant, his personal representative, parents, dependents, and next of kin," may seek compensation under the Plan by filing a claim for compensation with the Division of Administrative Hearings. Sections 766.302(3), 766.303(2), 766.305(1), and 766.313, Florida Statutes. The Florida Birth-Related Neurological Injury Compensation Association (NICA), which administers the Plan, has "45 days from the date of service of a complete claim . . . in which to file a response to the petition and to submit relevant written information relating to the issue of whether the injury is a birth-related neurological injury." Section 766.305(3), Florida Statutes.

27. If NICA determines that the injury alleged in a claim is a compensable birth-related neurological injury, it may award

    compensation to the claimant, provided that the award is approved by the administrative law judge to whom the claim has been assigned. Section 766.305(6), Florida Statutes. If, on the other hand, NICA disputes the claim, as it has in the instant case, the dispute must be resolved by the assigned administrative law judge in accordance with the provisions of Chapter 120, Florida Statutes. Sections 766.304, 766.307, 766.309, and

    766.31, Florida Statutes.

    
    

28. In discharging this responsibility, the administrative law judge must make the following determination based upon the available evidence:

    1. Whether the injury claimed is a birth- related neurological injury. If the claimant has demonstrated, to the satisfaction of the administrative law judge, that the infant has sustained a brain or spinal cord injury caused by oxygen deprivation or mechanical injury and that the infant was thereby rendered permanently and substantially mentally and physically impaired, a rebuttable presumption shall arise that the injury is a birth-related neurological injury as defined in s. 766.303(2).

       
       

    2. Whether obstetrical services were delivered by a participating physician in the course of labor, delivery, or resuscitation in the immediate post-delivery period in a hospital; or by a certified nurse midwife in a teaching hospital supervised by a participating physician in the course of labor, delivery, or resuscitation in the immediate post-delivery period in a hospital.

    Section 766.309(1), Florida Statutes. An award may be sustained only if the administrative law judge concludes that the "infant has sustained a birth-related neurological injury and that obstetrical services were delivered by a participating physician at birth." Section 766.31(1), Florida Statutes.

29. Pertinent to this case, "birth-related neurological injury" is defined by Section 766.302(2), Florida Statutes, to mean:

    . . . injury 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. This definition shall apply to live births only and shall not include disability or death caused by genetic or congenital abnormality.

    
    

30. As the claimant, the burden rested on Petitioner to demonstrate entitlement to compensation. Section 766.309(1)(a), Florida Statutes. See also Balino v. Department of Health and Rehabilitative Services, 348 So. 2d 349, 350 (Fla. 1st DCA 1977), ("[T]he burden of proof, apart from statute, is on the party asserting the affirmative issue before an administrative tribunal.")

31. Here, the proof failed to demonstrate that Shayla suffered 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 neurologically impaired.

    Rather, the proof is compelling that Shayla's neurologic impairment resulted from a Type IV hereditary, sensory and autonomic neuropathy unassociated with the events of labor or delivery. Consequently, the record developed in this case failed to demonstrate that Shayla suffered a "birth-related neurological injury," within the meaning of Section 766.302(2), Florida Statutes, and the subject claim is not compensable under the Plan. Sections 766.302(2), 766.309(1), and 766.31(1), Florida Statutes.

32. Where, as here, the administrative law judge determines that ". . . the injury alleged is not a birth-related neurological injury . . . he [is required to] enter an order [to such effect] and . . . cause a copy of such order to be sent immediately to the parties by registered or certified mail." Section 766.309(2), Florida Statutes. Such an order constitutes final agency action subject to appellate court review. Section 766.311(1), Florida Statutes.

CONCLUSION

Based on the foregoing Findings of Fact and Conclusions of Law, it is

ORDERED that the petition for compensation filed by Sheila Adame, as parent and natural guardian of Shayla Adame, a minor, be and the same is hereby denied with prejudice.

DONE AND ORDERED this 9th day of November, 2001, in Tallahassee, Leon County, Florida.

WILLIAM J. KENDRICK

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 9th day of November, 2001.

ENDNOTES

1/ During the course of her pregnancy, Ms. Adame was treated for chlamydia with antibiotics and for urinary tract infection with Bactrim; however, those difficulties had no apparent effect on the outcome of the pregnancy. Moreover, Ms. Adame was observed to be overweight and with blood pressure that was borderline high; however, she never became preeclamptic. Finally, some decrease in fetal movement was apparently observed during some point in the pregnancy; however, the timing, duration, or significance of any such incident is not clear from the record.

2/ Earlier, on May 28, 1997, and before an etiology for Shayla's presentation was established, Dr. Perszyk had observed that:

. . . [Shayla's] clinical picture would be most consistent with intrauterine ischemic hypoxic injury well before the process of labor and delivery. Because of the floppy tone present at birth without other neurologic sequellae, the exact etiology is

not clear. If this is a form of static encephalopathy, we would expect continued improvements as we are seeing over the months and years ahead. We were excited to see how alert Shayla was and seemed to be interested in her environment. At the same time her muscle tone alternations would be more consistent with a static encephalopathy at this time. However, if continued problematic care occurs and there is a change in picture with worsening neuromuscular function, there are certainly a number of conditions that we have not investigated that might be worth pursuing in this young infant with hypotonia

. . . developmental delay . . . and gastroesophageal reflux . . . .

Therefore, it would appear that if the abnormality evident on the MRI scan represents a hypoxic insult that, given her presentation at birth, it would be Dr. Perszyk's opinion that such injury occurred well before the process of labor and delivery.

3/ Having resolved that Shayla's neurologic dysfunction was not associated with any factor occurring during the course of birth it is unnecessary to address whether she has been rendered permanently and substantially mentally and physically impaired. Were it necessary to resolve such issue, further proceedings would be required to resolve whether the parties' stipulation to that effect should be accepted, given Dr. Duchowny's testimony that, as the only physician to address the issue, her mental impairment could best be described as mild to moderate. (Transcript, page 4, and Respondent's Exhibit 1, page 8).

4/ The testimony of Drs. Duchowny and Kalstone is logical, well reasoned, most consistent with the record and the opinions of Shayla's treating physicians, and has been credited. In contrast, Dr. Summers' testimony ignores extensive diagnostic examinations Shayla underwent, the opinions of physicians more qualified to assess causation and timing, and was in many respects (especially with regard to his opinion regarding spinal injury) speculative. Consequently, Dr. Summers' testimony has not been credited.

COPIES FURNISHED:

(By certified mail)

Robert E. Schack, Esquire

Law Offices of Gunion & Schack 9350 South Dixie Highway Miami, Florida 33156

W. Douglas Moody, Esquire McFarlain & Cassedy, P.A.

215 South Monroe Street Post Office Box 2174 Tallahassee, Florida 32301

Lynn Larson, Executive Director Florida Birth-Related Neurological

Injury Compensation Association 1435 Piedmont Drive, East, Suite 101

Tallahassee, Florida 32312

University Medical Center

3625 University Boulevard, South Jacksonville, Florida 32216

J. Pierce Murray, M.D. University Medical Center

3625 University Boulevard, South Jacksonville, Florida 32216

Ms. Charlene Willoughby

Agency for Health Care Administration Consumer Services Unit

Post Office Box 14000 Tallahassee, Florida 32308

Mark Casteel, General Counsel Department of Insurance

The Capitol, Lower Level 26 Tallahassee, Florida 32399-0300

NOTICE OF RIGHT TO JUDICIAL REVIEW

A party who is adversely affected by this final order is entitled to judicial review pursuant to Sections 120.68 and 766.311, Florida Statutes. Review proceedings are governed by the Florida Rules of Appellate Procedure. Such proceedings are commenced by filing one copy of a Notice of Appeal with the Agency Clerk of the Division of Administrative Hearings and a second copy, accompanied by filing fees prescribed by law, with the appropriate District Court of Appeal. See Section 120.68(2), Florida Statutes, and Florida Birth-Related Neurological Injury Compensation Association v. Carreras, 598 So. 2d 299 (Fla. 1st DCA 1992). The Notice of Appeal must be filed within 30 days of rendition of the order to be reviewed.

Docket for Case No: 00-001437N

Orders for Case No: 00-001437N