STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
JUAN CARLOS DONADO AND ANTONIO )
BALBUENA, as co-guardians of ) ROSA DONADO on behalf of the ) minor child, ANGEL BALBUENA, )
)
Petitioners, )
)
vs. )
)
FLORIDA BIRTH-RELATED )
NEUROLOGICAL INJURY )
COMPENSATION ASSOCIATION, )
)
Respondent. )
Case No. 03-1225N
)
FINAL ORDER
Pursuant to notice, the Division of Administrative Hearings, by Administrative Law Judge William J. Kendrick, held a hearing in the above-styled case on March 2, 2004, by
teleconference.
APPEARANCES
For Petitioners: Mary Margaret Schneider, Esquire
Steven R. Jaffe, Esquire Aronovitz Trial Lawyers Museum Tower, Suite 2700
150 West Flagler Street Miami, Florida 33130
For Respondent: M. Mark Bajalia, Esquire
Volpe, Bajalia, Wickes, Rogerson & Galloway
1301 Riverplace Boulevard, Suite 1700
Jacksonville, Florida 32207
STATEMENT OF THE ISSUE
Whether Angel Balbuena, a minor, qualifies for coverage under the Florida Birth-Related Neurological Injury Compensation Plan.
PRELIMINARY STATEMENT
On March 31, 2003, Juan Carlos Donado and Antonio Balbuena, as co-guardians of Rosa Donado, on behalf of Angel Balbuena, 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). The motivation for filing the claim was stated to be, as follows:
Petitioners have previously filed an Amended Complaint for Damages in the Circuit Court for the 11th Judicial Circuit in and for Miami-Dade County, styled Juan Carlos Donado and Antonio Balbuena, as Co-Guardians of Rosa Donado, on behalf of Rosa Donado and her minor child, Angel Balbuena, a minor, and Antonio Balbuena, Individually, vs.
Lifemark Hospitals of Florida, Inc. d/b/a Palmetto General Hospital, Richard S. Friefeld, M.D., and Richard S. Friefeld, M.D., P.A., Miami-Dade Circuit Court Case No. 02-20932 CA 01 . . . . It is
Petitioners' position that the injuries to ANGEL BALBUENA are not compensable under NICA, however, the current status of Florida law requires this determination be made by the administrative law judge. The Honorable Peter Lopez has entered an Agreed Order
. . . abating the claim in the Miami-Dade County Circuit Court with respect to the physical injuries of ANGEL BALBUENA so that [an administrative law judge can make] a
determination of whether this claim is compensable under NICA.
Under the circumstances, Petitioners requested "a determination of applicability of Chapter 766.304 be made to determine the benefits available to themselves and the minor child,
ANGEL BALBUENA, pursuant to the Florida Statutes governing birth related neurological injury."
DOAH served the Florida Birth-Related Neurological Injury Compensation Association (NICA) with a copy of the claim on April 3, 2003, and on August 1, 2003, NICA filed a Motion for Summary Final Order, predicated on the opinion of its expert that Angel's impairments were more likely than not associated with prenatal (developmental) events, as opposed to brain injury caused by oxygen deprivation during labor, delivery, or resuscitation. By Order of August 15, 2003, NICA's Motion for Summary Final Order was denied, and on August 25, 2003, NICA gave notice that it was of the view that Angel did not suffer a "birth-related neurological injury," as defined by Section 766.302(2), Florida Statutes (2000),1 and requested that the issues of compensability and award be bifurcated. NICA's request was granted, and a hearing was ultimately held on
March 2, 2004, to address the issue of compensability.
At hearing, Petitioners' Exhibits 1A-1E, 2, and 3, and Respondent's Exhibits A-F, were received into evidence.2 No witnesses were called, and no further exhibits were offered.
The transcript of the hearing was filed March 15, 2004, and the parties were accorded 10 days from that date to file proposed orders. Petitioners and Respondent elected to file such proposals, and they have been duly considered.
FINDINGS OF FACT
Preliminary findings
Antonio Balbuena is the natural father of
Angel Balbuena (Angel), a minor, and Juan Carlos Donado and Antonio Balbuena are co-guardians of Rosa Donado, the natural mother of Angel. Angel was born a live infant on February 5, 2001, at Palmetto General Hospital, a hospital located in Dade County, Florida, and his birth weight exceeded 2,500 grams.
The physicians providing obstetrical services at Angel's birth were Richard Friefeld, M.D., and Jose Abreu, M.D., who, at all times material hereto, were "participating physician[s]" in the Florida Birth-Related Neurological Injury Compensation Plan, as defined by Section 766.302(7), Florida Statutes.
Angel's birth
At or about 3:30 p.m., February 4, 2001, Ms. Donado presented to Palmetto General Hospital, for induction of labor.
Ms. Donado received cervidil overnight and IV hydration, and the baby's tracing was noted as reactive.
At approximately 6:33 a.m., February 5, 2001,
Ms. Donado's membranes spontaneously ruptured. Shortly thereafter, Ms. Donado "complained she couldn't breathe and proceeded to have seizure-like movements;" at approximately 6:40 a.m., full code was called for cardiopulmonary arrest; and at 6:59 a.m., Angel was delivered by stat cesarean section.
At delivery, Angel was depressed (limp, with no tone, spontaneous movement, or respirations), and was immediately given oxygen by bag and mask, with improvement in color and heart rate over 100 beats per minute, and then intubated. Apgar scores were recorded as 4, 5, and 5, at one, five, and ten minutes, respectively,3 and cord pH was recorded at 6.66.
Following resuscitation, Angel was transported to the neonatal intensive care unit (NICU), where he was admitted at approximately 7:30 a.m. The Neonatal Admission History and Physical provided, in part, as follows:
Maternal History . . . .
Mother is 43 y/o . . . who received pre- natal care by Dr. Freifeld. Pregnancy complicated by Gestational diabetes Diet controlled. Mother also had Amnio for AMA [Advanced Maternal Age] of 43 which showed 46XY. No other problems or complications.
Delivery low trans. Cesarean section . . . .
Resuscitation: mask vent, ET tube, med. volume
Maria Oliver, M.D. [a neonatologist] was called to the delivery room because of Maternal cardio-respiratory arrest.
Delivery analgesia used: general- intubation. Suctioning at delivery: bulb. The respiratory effort at birth was delayed. Delivery outcome: live birth admitted to ICN.
Cord Venous Gases: VEN pH=6.66 pCO2=184 p02=5 BE=-16.5
Called stat to attend an emergent primary C/S due to maternal Cardio-Respiratory arrest, for a presumptive Dx. of Amniotic fluid embolism. Mother came to Palmetto on 02/04/01 for Cervidil induction for 40wk preg. Mother received Cervidil overnight and IV hydration, the baby's tracing was reactive, at approx. 6:33am mother had spontaneous ROM and by nursisng [sic] and father's account immediately complained that she couldn't breath [sic] and proceded [sic] to have seizure like movements at 6:40 am full code was initiated and baby was delivered at 6:59 am. Baby was born via stat c/s w/triple nuchal cord around neck, limp, no tone or spontaneous movements or respirations, immediate bag and mask initiated w/improvement in color HR>100, and chest movement, immediately intubated, w/excellent chest exclusion, NO spontaneous movements, NO spontaneous respirations, NO grimance [sic] or reflex. Baby received 20cc/KG of Lactated ringers as volume expander, followed by 2meq/kg of NaBicarb9 presumed weight of 3kg. Baby's color improved to pink from pale/ash, good pulses, HR>100, excellent chest mevements [sic] and breath sounds w/bagging, was transported to NICU in pre-heated isollete, for further stabilization and diagnostic w/u. The
umbilical cord appeared mec. stained though no mec. was noted at time of rupture of membranes.
ADMISSION HISTORY: Baby was briefly placed on high-frequency vent, but HR began to drop and responded to convetional [sic] vent well, no seizures noted . . . . At about 1 hr of life baby started to grimace w/light stimuli and prior to second hour of life opened eyes spontaneouly [sic] briefly, there is sucking movement, and upper extremety [sic] movement . . . .
Examination . . . .
GENERAL: hypotonic, distressed, pale pink SKIN: pale, pink
HEAD: open, anterior fontanelle
EYES: initially fixed and dilated, but at about 2 hrs became reactive to light . . . .
LUNGS & CHEST: paradoxical respirations, on conv. ventilation
CARDIAC: normal rate and rhythm, no murmur
* * *
LIMBS & HIPS: upper extrem showing some movement, lower still poor movement
NEUROLOGIC: hypotonic, s/p severe perinatal stress, and metabolic acidosis low APGARS, starting to respond to light stimuli . . . .
Assessments & Plans
ASSESSMENT: Term male, severe perinatal stress, low APGAR's, severe metabolic acidosis, Nuchal cord X3, R/O sepsis, MaternalCardio-resp. arrest. Possible maternal amniotic fluid embolism.
ADMIT DIAGNOSES: Perinatal depression (admit), maternal cardio-resp arrest. Respiratory distress (admit). Term infant (admit). Metabolic acidosis. Suspected sepsis (admit) . . . .
ADMIT PLAN: . . . Neurology (Dr. Bustamante) consult, EEG Dopamine
drip, Na.bicarb to correct MA.
Following admission to NICU, Angel had an electroencephalogram (EEG) to evaluate for seizure activity. That study was read as abnormal, with the following impression:
MARKEDLY ABNORMAL STUDY. DYSRRHYTHMIA GRADE 3, SUBCONTINOUS ELECTROGRAPHIC SEIZURES CORRELATING WITH SUBCONTINUOUS BIFRONTAL EPILEPTIFORM ACTIVITY (LEFT GREATER THAN RIGHT) SUPERIMPOSED ON A SUPPRESSION GRADE 2 PATTERN. CLINICAL CORRELATION IS ADVISED AND A FOLLOW UP STUDY IS SUGGESTED.
Angel also had a head ultrasound to evaluate for intracranial abnormalities. That ultrasound was read as follows:
The study shows normal visualization of the ventricular system and corpus callosum as well as of the germinal matrix without evidence of abnormality to suggest the presence of subependymal or intraventricular bleed.
IMPRESSION:
NORMAL ULTRASOUND OF THE INFANT HEAD.
At 11:50 p.m., February 5, 2001, Martha Bustamante, M.D., a pediatric neurologist, examined Angel at the request of Dr. Oliver. Following evaluation, Dr. Bustamante recorded her assessment and plan (A/P) as follows:
. . . s/p severe perinatal asphyxia, required prolonged & vigorous resuscitation, nuchal cord x 3 [with] meconium stained amniotic fluid. Severe metabolic acidosis
. . . . Status Epilepticus - [continue] anticonvulsant med[ication] phenobarb . . .
will get [followup] EEG in 48 [hours]
. . . .
Suspect multiorgan involvement. Already [decreased] urine output [with increased] Bun, Creat . . . .
Continue hyperventilation/supportive care.
guarded prognosis
On February 6, 2001, Dr. Bustamante recorded the results of a 10:15 p.m., examination as follows:
No further [seizures] since last night. No active bleeding.
Neuro exam - no continuous obligate asymmetric tonic neck reflex but still [with] head/neck preferences to [left]. [Positive for] asymmetrical U[pper] E[xtremity]'s limb move[ment] noted at rest and [decreased] move's [with] R[ight] U[pper] E[xtremity]. [Positive for] cortical thumbs and diffuse hypertonia . . .
Continue close observation over renal output/Bun, Creat. . . [Followup] EEG tomorrow.
A/P - Showing improving neuro status following severe hypoxic-schemic insult. Continue aggressive supportive care. Get P[hysical] T[herapy]/O[ccupational] T[herapy] input . . . and S[peech]
T[herapy] in future.
On February 7, 2001, Angel extubated himself, was placed on an oxyhood for a brief period, and then transitioned
to room air. Followup EEG on February 7, 2001, was read as abnormal, with the following impression:
ABNORMAL STUDY DUE TO THE PRESENCE OF INTER- ICTAL MULTIFOCAL EPILEPTIFORM ACTIVITY. THIS STUDY IS CLASSIFIED AS A DYSRHYTHMIA GRADE II/MULTIFOCAL. THIS FOLLOW UP STUDY SHOWS MARKED IMPROVEMENT WHEN COMPARED TO THE PRIOR STUDY OF 2/5/01. CLINICAL CORRELATION IS ADVISED.
Dr. Bustamante recorded the results of her neurologic examination of February 7, 2001, as follows:
. . . No further [seizures] [Followup] EEG = multifocal spikes[,] phenobarb level 22[.] [Patient] extubated himself and breathing on his own.
Neuro-Obtunded [with] intermittent hypervigilant state c[onsistent]/w[ith] H[ypoxic] I[schemic] E[ncephalopathy]. [Increased] tone in all limbs, profound head lag. [Positive for] diffuse hyper-reflexia. Facial dipligia [with] gaging [with] poor suck on own secretions suggestive of dysphagia. [Upgoing] plantars. Fisted hands.
Over the next two days, Angel showed improved neurologic status, and on February 9, 2001, the following NICU Progress Note was entered:
Interim events: Angel remains extubated, stable in room air, no A's and B's, responds w/eye movement, and upper extrem movement to voice, light and touch stimuli, lower extremities not hypertonic, NO gag, NO cry, No seizures on Phenobarb, all other organ systems stable, excellent urine output, will start minimal feeds today.
Angel's neurologic progress continued to show improvement, and on February 12, 2001, the following entry appeared in the NICU Progress Note:
EXAM: responsive to touch, and voice, attempting moving upper extremities, (+)eye opening, gag reflex present.
GENERAL: quiet, hypotonic HEENT: open, anterior fontanelle normal shape and size, equal red reflexes, equally reactive pupils normally set, no anomalies patent nares, intact palate. RESPIRATORY: symmetric chest, no distress, clear and equal breath sounds supple neck, intact clavicles.
CARDIAC: normal rate and rhythm, no murmur. ABDOMEN: 3 vessel cord. NEUROLOGIC: weak, discoordinated suck, hypotonic . . . .
EXTREMITIES: 10 fingers and toes, stable hips, symmetric, moves all 4, straight spine . . . .
Since Angel had been seizure-free since February 5, 2001, phenobarbitrol was discontinued pending the results of a "cat scan/mri." The brain CT was done February 12, 2001, and read as normal.
Dr. Bustamante reported the results of her February 16, 2001, neurologic examination as follows:
H[ead] C[ircumference] 34 cm [up] 1 cm from birth. Last [seizures] 2/5/01. Feeding better since 2/15/01. Plain brain CT 2/12/01 reported as (-). Receiving OT/ST/PT . . . .
Neuro . . . .
MS: lethargic [with decreased] alertness & responsiveness. [Positive for] weak cry. [Positive for] fairly good suck.
CN: not visually fixating. [Positive for] roving-like move's, not tracking . . . [decreased] facial tone/expression [with] subtle [right] facial droop.
Motor: [decreased] tone in axial & upper ext[remities] musculature. [Increased] tone in L[ower] E[xtremities]. [Positive for] intermittent asymmetrical posturing/moves [with] R[ight] U[pper] E[xtremity] in ext./ L[eft] U[pper] E[xtremity] in flexion, R[ight] L[ower] E[xtremity] in ext & LLE in flex suggestive of R>L weakness, hyper- reflexia diffusely but no clonus.
Sensory: Withdrawals fairly symmetrically to painful/tactile stimuli.
A/P Hypoxic Ischemic Encephalopathy. Off phenabarb since 2/12 and no [seizure] recurrence since last [seizure] on 2/5/01. While in house continue supportive care and current therapy . . . . [Patient] will need out pt. rehab. PT/OT + ST.
Angel was discharged from Palmetto General Hospital on February 19, 2001, and his Neonatal Discharge Summary4 noted the following discharge exam and discharge plan:
Discharge Exam . . . .
GENERAL: alert and active, pink and well perfused
* * *
LUNGS & CHEST: no distress, clear and equal breath sounds
CARDIAC: normal rate and rhythm, no murmurs, good femoral pulses
* * *
LIMBS & HIPS: moves all 4 limbs, stable hips
NEUROLOGIC: normal suck, symmetric Moro, decreased strength and tone
Discharge Plans
The follow up provider at discharge was unknown. The parents were instructed to call for an appointment in 1 week. A home health referral was made.
Additional appointments: Developmental clinic, neurology f/u opp[,] infant referred for developmental follow-up testing
. . . .
Angel's subsequent development
Following discharge from Palmetto General Hospital, Angel was referred for follow-up to Celadie Fiallo, Jr., M.D., a pediatrician practicing as Pediatrics-R-Us, P.A., and the University of Miami School of Medicine Early Intervention Program.
In so far as the record reveals, Angel was seen on two occasions at the Early Intervention Program: on March 27, 2001, and October 17, 2001. Angel's visit of March 27, 2001, was reported as follows:
Medical Assessment: Angel was referred by Palmetto hospital because of perinatal asphyxia and neonatal seizures . . . .
Angel has been doing well since discharge from the hospital . . . . Physical exam is remarkable for hypertonia of back muscles and lower extremities. He can lift his head in the prone position and visually track an
object . . . . His vision appears normal. He passed hearing today.
* * *
Recommendations: Based on the above results and on observations of Angel's behavior during the evaluation today it is recommended that:
Continue follow up with pediatrician.
Refer for physical therapy 2 times per week for hypertonia . . . .
Angel's visit of October 17, 2001, was reported as follows: Medical Assessment: Developmentally,
he rolls over both ways and bubbles. Angel
has good appetite, eats baby food and some solid foods and drinks milk from the bottle. Physical exam is remarkable for left esotropia. Neuromuscular exam shows increased muscle tone in all extremities.
He tends to keep his hand[s] fisted but will open them to reach. Mild shoulder retractions. DTR's are brisk. Absent left lateral protective reflex. Right is present as well as parachute. Vision appears normal and he passed hearing test on 3/27/01.
Developmental Assessment:
Tests Administered: Bayley Scales of Infant Development/Developmental Profile (DPIYC)
* * *
Bayley:
The Bayley Scale resulted in a Mental Development score within the average range, developmental equivalent of 7 months; and Motor Development score within the delayed range, developmental equivalent of 6 months.
DPIYC Test Results:
Cognitive (8 months): Angel can attain a completely hidden object.
Communication: (7 months): Angel can localize sound source.
Fine Motor (8 months): Angel can scoop a pellet.
Gross Motor (6 months): Angel can roll from back to stomach.
Social: (8 months): Angel can reach for image of self in mirror.
Adaptive (7 months): Angel can drink from cup with help.
* * *
Recommendations/Referrals: Based on the above results and on observations of Angel's behavior during the evaluation today it is recommended that:
Physical therapy to assist with his gross motor skills.
Continue follow up with pediatrics . . . .
Angel was initially seen by his pediatrician,
Dr. Fiallo on March 12, 2001. By October 2001, Dr. Fiallo had referred Angel for a physical therapy evaluation to address a perceived delay in motor development. That evaluation concluded Angel evidenced mild generalized hypertonia, with a gross motor development level at 7 months, and recommended physical therapy twice a week. Dr. Fiallo concurred with this evaluation and certified the need for physical therapy (2 times a week for 6
months) to Medicaid, with a rehabilitation potential of "good," as opposed to "fair" or "poor."
Subsequently, on November 5, 2001, Angel's guardian reported evidence of possible seizure activity, and Dr. Fiallo referred Angel for an EEG and an MRI of the brain. Angel's guardian did not keep the appointment for the EEG, but the MRI was done at Miami Children's Hospital on November 9, 2001, and reported as follows:
HISTORY: Nine month old evaluated for seizures and developmental delay.
* * *
FINDINGS: The ventricles are normal in size and position. The white matter myelin pattern is very incomplete. There is symmetric hypomyelination in the biparietal periventricular white matter extending into the corona radiata on the T2 weighted studies. It appears slightly more pronounced than physiologic terminal zones. The remainder of the myelin pattern is unremarkable for age. There are no abnormal sites of contrast enhancement. There is no significant structural brain anomaly apparent.
CONCLUSION:
There is hypomyelination in the biparietal white matter which appears more pronounced than physiologic terminal zones. In view of the history of developmental delay and seizures, follow-up MR is recommended to reassess the myelination and verify appropriate maturation of the brain. Clinical correlation is also recommended to evaluate whether the patient has a static or progressive encephalopathy.
Thereafter, the EEG was rescheduled for July 17, 2002, at Miami Children's Hospital. That appointment was kept, and the EEG was reported as follows:
IMPRESSION: Abnormal EEG study obtained in the awake, drowsy and sleep states because of the multifocal epileptiform discharges and the asymmetric background. These findings indicate a multifocal cerebral dysfunction left more than right which is potentially epileptogenic.
Following the results of the EEG, Dr. Fiallo referred Angel to Miami Children's Hospital for evaluation by
Michael Duchowny, M.D., then Director, EEG Laboratories and Seizure Unit, Miami Children's Hospital, and Clinical Professor in Pediatric Neurology, University of Miami School of Medicine. That evaluation, done on January 21, 2003, was reported as follows:
Angel is a 1 year, 11 month old male with developmental delay and history of episodes of crying and shaking during sleep . . . .
An EEG was done on 07/17/02, which demonstrated multifocal epileptiform discharges indicating multifocal cerebral dysfunction greater on the left side than the right side. MRI of the brain was done on 11/09/01 and demonstrated biparietal white matter hypomyelination He
gets physical therapy, but no speech therapy at this time. Developmentally he has been delayed and walked at 19 months.
A review of Angel's PRE and PERINATAL HISTORY shows him to be the product of a pregnancy without complications. He was born at term after spontaneous rupture of
membrane. Labor was complicated by maternal cardiopulmonary arrest, which was followed by emergency caesarean section. He had respiratory distress at birth and was intubated for seven [sic] days. He spent 15 days in the Palmetto Hospital Neonatal Intensive Care Unit. His birth weight was 7-pounds, 3-ounces. There were no other neonatal complications according to his foster mother.
* * *
REVIEW OF SYSTEMS: Restless sleep as described above. He has no history of cardiac, lung, GI, or GU disorders. His foster mother notices that his muscles are "tense."
PHYSICAL EXAMINATION shows him to be alert and in no acute distress. Weight is 25 pounds, 1-ounces. Head circumference is
46.5 cm, which places him at about the 25th percentile. There are no dysmorphic features or neurocutaneous manifestations. His tonsils are 1+bilaterally. Abdoment is soft with no organomegaly. Spine and extremities are normal. He transfers, and has bilateral parachuting responses.
NEUROLOGIC EXAMINATION: His mental status is attentive. He follows commands very well, but has minimal speech production. He mostly makes unintelligible sounds. Cranial nerves II through XII are intact. Fundi show no apparent retinopathy. Motor examination reveals normal bulk, tone, and strength and use of all four extremities.
He has minor decrease in fine motor ability in both upper extremities. The deep tendon reflexes are 3+ throughout and brisk, with no clonus and symmetrical. Plantar responses are flexor bilaterally. On cerebellar coordination, there is no tremor or abnormal movements. His gait is somewhat wobbly and he falls frequently if not assisted.
IMPRESSION: 1) Global developmental delay.
2) Speech delay. 3) Paroxysmal nocturnal motor events, questionable for seizures. 4) Oromotor apraxia. 5) Snoring. 6) Abnormal EEG and MRI.
PLAN: 1) Would be beneficial to see the nocturnal events and his foster mother states that she will attempt to video these events and bring us an example. 2) Occupational and speech therapies in addition to physical therapy . . . .
Coverage under the Plan
Pertinent to this case, coverage is afforded by the Plan for infants who suffer a "birth-related neurological injury," defined as an "injury to the brain . . . caused by oxygen deprivation . . . occurring in the course of labor, delivery, or resuscitation in the immediate postdelivery period in a hospital, which renders the infant permanently and substantially mentally and physically impaired." § 766.302(2), Fla. Stat. See also §§ 766.309 and 766.31, Fla. Stat.
In this case, Petitioners are of the view that during the course of labor, delivery, or resuscitation, Angel suffered an injury to the brain caused by oxygen deprivation, secondary to his mother's cardiopulmonary arrest, that rendered him permanently and substantially mentally and physically impaired. In contrast, NICA is of the view that, while Angel's mother suffered a cardiopulmonary arrest, the proof fails to support the conclusion that any oxygen deprivation Angel may have
suffered was sufficient to produce brain injury, and that his impairments were, more likely than not, related to prenatal (developmental) events. Moreover, NICA is of the view that regardless of the etiology of Angel's developmental delay, he is not permanently and substantially mentally and physically impaired.
The cause and timing, as well as the significance of Angel's impairment
To address the cause and timing of Angel's impairment, as well as its significance, the parties offered certain records related to Angel's birth and subsequent development, portions of which have been addressed supra and portions of which will be addressed infra (Petitioners' Exhibits 1A-1E and 2, and Respondent's Exhibits A-C and E); the deposition of
Steven Abern, M.D., a physician board-certified in pediatrics, and neurology with special competence in child neurology (Petitioners' Exhibit 3); the deposition of Michael Duchowny, M.D., a physician board-certified in pediatrics, neurology with special competence in child neurology, and clinical neurophysiology (Respondent's Exhibit F); and an affidavit of Dr. Duchowny (Respondent's Exhibit D).
Dr. Abern, whose deposition was offered on behalf of Petitioners, was of the opinion, based on his review of the medical records and his neurologic evaluation of Angel on
January 20, 2003,5 that Angel was permanently and substantially mentally and physically impaired, and that, more likely than not, his impairment resulted from a brain injury caused by oxygen deprivation that occurred during labor, delivery, or resuscitation. Dr. Abern described the results of his examination as follows:
. . . Approximately two-year old right [handed] Hispanic male . . . . In therapy for not walking, walks unsteady. No language, just babbles Has
appointment with neuro[logist Dr. Duchowny] tomorrow . . . .
7/02 abnormal EEG. [M]ultifocal epileptiform discharges left greater than right as well as continuous slow left hemisphere. In therapy two times a week for
45 minutes for two months. short
thumbs, slobbers a lot, no regression
. . . . Toddler walk, wide based . . . .
No concerns with hearing or vision . . . .
[F]unctioning at approximately one-year level . . . . Rudimentary pincer . . . .
(Petitioners' Exhibit 3, pages 49-51) Notably, Dr. Abern characterized the results of his examination as consistent with the results of Dr. Duchowny's examination of January 21, 2003, in that he observed, as did Dr. Duchowny, "normal tone, normal strength, no tremor or abnormal movements. His gait is somewhat wobbly, and he falls frequently if not assisted." (Petitioners' Exhibit 3, page 54)
With regard to the etiology of Angel's impairment, Dr. Abern was of the opinion that Angel's impairments were the "sequela" of a "profound hypoxic ischemic insult at the time of birth secondary to his mother's cardiopulmonary arrest." (Petitioners' Exhibit 3, page 24) In so concluding, Dr. Abern noted Angel's severe depression at birth; the presence of a triple nuchal cord around the neck; the need for prolonged resuscitation; a cord blood pH consistent with severe acidosis; evidence of seizure activity within the first few hours of life; evidence of multiple organ abnormalities; and the need for medication (Dopamine) to maintain blood pressure. Dr. Abern was also of the opinion that the MRI scan of November 9, 2001, revealed brain injury, consistent with a hypoxic ischemic insult at birth. Dr. Abern explained his reasoning as follows:
Q. It is your opinion that the MRI for Angel Balbuena done on November 9, 2001, is consistent with Angel having experienced an hypoxic insult during labor and delivery?
A. Yes, it is.
Q. How so?
A. How so, because if you read the report where there is the -- there is symmetric, and he uses the words hypomyelination, in the biparietal periventricular white matter extended into the corona radiata on a T2 weighted studies. It appears slightly more pronounced than physiologic internal zones.
I would call it a periventricular leukodystrophy because where these leucines that he's calling the hypomyelination is in the watershed areas which is where you would expect a child who has no blood pressure and lack of oxygen or decreased blood flow to have the damage which is exactly where you see it.
(Petitioners' Exhibit 3, pages 33 and 34)
In weighing Dr. Abern's opinion regarding the significance of Angel's impairment, the following observations by Dr. Abern are worthy of note:
Q. Is it your opinion that Angel Balbuena is permanently and substantially mentally impaired?
A. What do you mean mentally impaired? Let's define that term.
Q. How would you define an infant that is mentally impaired?
A. There is [sic] lots of ways to define it. That's why I am asking. He is developmentally delayed. When I saw him, he had some motor problems. I know that he had some speech problems, but I can't tell you cognitively because I don't have enough information.
* * *
Q. Is it your opinion that Angel Balbuena is permanently and substantially physically impaired?
A. He is physically impaired. Whether it is permanent, with his therapies he may be corrected. But right now at this point in time with the snapshot I would say, yes.
Q. You would say, yes, he is permanently and substantially physically impaired?
A. At this point in time.
Q. Based on the records you have seen and based upon your evaluation of Angel Balbuena, do you have an opinion as to whether or not he has been improving from a physical standpoint since his birth?
A. From the records that I've seen, he has improved.
Q. Do you expect him to continue to improve?
A. That is the hope.
* * *
Q. What was your impression based upon your evaluation [of January 20, 2003]?
A. My impression is that he was functioning at approximately one-year developmental level. He was going to see Dr. Duchowny the next day. I was concerned that this child may be having seizures from taking the history. And that the child is developmentally motorically and language delayed.
Q. You said motorically?
A. Motorically.
* * *
Q. Based on your evaluation, what is the nature of Angel's motor delay?
A. The brain damage that he had at or near the time of his birth.
Q. Let me ask it another way. How is he delayed from a motor standpoint?
A. He is two years old. He is just starting to walk. He doesn't have a fine motor rudimentary pincer. His developmental milestones were delayed.
Q. In your opinion, based upon your evaluation, did Angel have hypotonia?
A. I did not find any hypotonia.
Q. What is hypotonia?
A. Low tone.
Q. In your opinion, based upon your evaluation, did Angel suffer any ataxia?
* * *
A. . . . I didn't write it down, and I don't recall. . . . I can tell you that his gait was wide based and [sic] in a toddler.
Q. What's the significance of that finding?
A. That he's walking and that he's a toddler gait. All children when they start to walk walk somewhat wide based.
Q. So that's essentially normal?
A. That's essentially normal at that point in time, correct.
Q. Other than the finding that he was two years old and just starting to walk, were there any other motor deficits that you found on your evaluation?
* * *
A. The fine motor, the rudimentary pincer grasp.
Q. Explain that, the rudimentary pincer grasp.
A. You ask a child to pick up a Cheerio. They usually start with their whole hand and then they progress to the thumb and forefinger so they can pick up an individual Cheerio. His was rudimentary.
Q. What do you mean by rudimentary?
A. Development -- it was delayed. It was not developed as well as it should have been.
Q. What other impression, if any, did you have based upon your evaluation on
January 20, 2003?
A. That was basically what I had. I knew he was going to see Dr. Duchowny the next day, and then Dr. Duchowny's exam basically confirms mine. It reveals normal tone, normal strength, no tremor or abnormal movements. His gait is somewhat wobbly, and he falls frequently if not assisted.
(Petitioners' Exhibit 3, pages 24-26, and 51-54)
As for the implications of Ms. Donado's cardiopulmonary arrest, Dr. Abern offered the following additional observations:
Q. In your opinion, how long and how severe was the hypoxic insult experienced by Angel in this case?
A. Angel's mother arrested around 6:45 in the morning. He was born at 6:59 in the morning. So there was approximately a 15- minute, 20-minute period of time he was compromised.
* * *
Q. If Angel had experienced an insult for
15 to 20 minutes during labor and delivery,
would you have expected his transition from the intrauterine [environment] to the . . .
. Extrauterine environment to be more difficult than what was reported in the medical records?
A. No, because the child has a reserve.
Q. Meaning what?
A. Meaning that the placenta is still providing some of the nutrition, some of the oxygenation for him. It's not a total abrupt. He's still getting some blood flow, still getting some oxygen, and the child has their own reserve.
* * *
Q. So even though there may have been an infarct in the placenta as you described earlier, the affect on the child may not have been as significant given those reserves and the continual nourishment of the placenta?
* * *
A. It may or may not have been. I don't know what the child's reserves were.
(Petitioners' Exhibit 3, pages 38, 47, and 48)
Dr. Duchowny, who had examined Angel at the request of his pediatrician on January 21, 2003, conducted a follow up examination on July 16, 2003, at the request of NICA.
Dr. Duchowny reported the results of his follow-up visit as follows:
I reevaluated Angel Balbuena on July 16, 2003. Angel is now 2 1/2 years old . . . .
As you know, Angel was previously evaluated by me on January 21, 2003. At that time he
was almost two years old and presented with developmental delay and nocturnal episodes .
. . . The major concern at that time focused on periodic nocturnal awakenings in which he would cry and appear to be fearful. He has also had one episode of unresponsiveness without motor accompaniments.
An EEG on July 17th had revealed multifocal epileptic abnormalities. He was on no intercurrent medications.
Angel's DEVELOPMENTAL MILESTONES were
consistently delayed. He was not speaking at his first evaluation and had only recently begun taking steps at age 19 months. His examination confirmed his delayed speech and development. The etiology of his nocturnal motor events was not specified.
Over the past six months Angel has made some limited progress. He is now speaking six or seven words and his father feels his motor abilities have improved across the board.
He is still quite unstable, however, and will fall intermittently. He cannot run on his own . . . . Angel is receiving physical and speech therapy on a twice weekly basis and his caretaker supplements these exercises at home . . . .
PHYSICAL EXAMINATION reveals him to be alert and cooperative. His head circumference measures 46.7 cm, which is within standard percentiles for age. His fontanels are closed. The hair is dark brown and of normal texture. He weighs 26 pounds. The neck is supple without masses, thyromegaly or adenopathy, and the cardiovascular, respiratory and abdominal examinations are unremarkable.
Angel's NEUROLOGIC EXAMINATION reveals him to be sitting up and attentive. He plays with toys and uses both hands. He is quite sociable. He did not talk in words during
the evaluation but he clearly communicated his needs and responded to simple commands. His cranial nerve examination reveals full visual fields to confrontation testing and normal ocular fundi. The pupils are 3 mm and are briskly reactive to direct and consensually presented light. There are no facial asymmetries. His tongue movements are poorly coordinated. There is minimal drooling. Motor examination reveals mild generalized hypotonia in a symmetric distribution. There is no focal weakness, atrophy, or fasciculations. He has good bimanual skills and individual finger movements. His deep tendon reflexes are slightly exaggerated at 3+. He can stand and bear weight and is able to walk across the room. However, his gait is somewhat unstable and there is head titubation and a wide-based stance. He has a tendency to fall in either direction. There are no specific focal or lateralizing findings.
In SUMMARY, Angel's neurologic examination reveals evidence of speech delay and generalized hypotonia with ataxia. He has progressed since his previous evaluation in January.
(Respondent's Exhibits D and E)
Based on his neurologic evaluations and review of the medical records, Dr. Duchowny was of the opinion that:
Although Angel clearly had a difficult delivery, significantly impaired cord blood gases, and an immediate need for intubation and ventalitory support, I do not believe that Angel's neurologic impairments were acquired in the course of labor and delivery. My opinion is based on the neurologic findings of generalized hypotonia and ataxia, which are more consistent with prenatally acquired cerebral palsy. His MRI performed on November 9, 2001 is consistent with this formulation as it demonstrates
biparietal white matter hypomyelination, findings that are not indicative of a hypoxic ischemic insult acquired during labor or delivery.
(Respondent's Exhibit E) Dr. Duchowny was also of the opinion that Angel was neither substantially mentally nor physically impaired.
In his deposition testimony, offered on behalf of NICA, Dr. Duchowny elaborated on his opinions as follows:
Q. What happens to an infant when the mother is having cardiopulmonary arrest?
A. It depends on the severity of the arrest. Anywhere from nothing to catastrophic circumstances to the infant.
Q. What was the severity of Angel's mother's cardiopulmonary arrest?
A. Well, I think that -- it's not clear . .
. .
Q. So is it then unclear what effect the cardiopulmonary arrest of Angel's mother had on Angel?
A. No, I think that was clear. I don't think it had an effect on Angel.
Q. Well, why is it clear as to Angel and not clear as to his mother?
A. Because Angel didn't suffer brain damage as a result of his mother's cardiopulmonary arrest.
Q. And what about the hypoxic ischemic damage?
A. His neurologic examination is not consistent with the effects of hypoxic
ischemic damage and his MRI scan is not consistent with hypoxic ischemic damage, and there is also a maternal history of developmental delay, which predates the pregnancy, but that's less important.
* * *
Q. What is the extent of Angel's developmental delay?
A. He has a speech delay. He's got delayed coordination and he has delay in mature muscle tone, low muscle tone.
* * *
Q. Was Angel delayed in any of his developmental milestones?
A. Yes, he was delayed in his motor and speech milestones.
* * *
Q. Do you agree that Angel Balbuena is substantially mentally and physically impaired?
A. No.
Q. Do you agree that Angel's mental and physical impairments such as described are permanent?
A. No.
Q. Do you agree that Angel Balbuena suffered from oxygen deprivation in the course of labor and delivery?
A. No.
Q. So it is your testimony today, Doctor, that even though Angel Balbuena's mother suffered a cardiac arrest and was resuscitated, was being resuscitated for
almost 20 minutes, that had no effect on Angel's oxygen supply to his brain?
A. It may have had an effect on the oxygen supply to Angel's brain, but Angel doesn't have hypoxic ischemic damage.
Q. Well, what effects did the oxygen deprivation to Angel's brain during his mother's cardiopulmonary arrest before his delivery have on him? What were the effects?
A. None, as far as I can tell. I mean, there may have been some transient physiologic disruption, but no permanent effects.
* * *
Q. You mention in your letter of July 23rd, 2003 that it is your opinion that Angel's neurologic findings are more consistent with prenatally acquired cerebral palsy. What is cerebral palsy?
A. Developmental disorder of motor functioning.
Q. What causes cerebral palsy?
A. Most of the cases are due to unknown intrauterine circumstances.
Q. What is the cause in Angel's case?
A. Intrauterine factors. I don't know the precise cause, but I believe they were acquired in utero.
Q. What is the factual basis for your belief that these occurred in utero?
A. His neurologic examination, the MRI findings.
Q. What in the neurologic examination factually supports your opinion that Angel's neurological deficits occurred prenatally or intra-utero?
A. The findings of hypotonia, ataxia and speech delay are all developmentally based and likely to be related to intrauterine factors.
* * *
Q. What is the factual basis for your opinion that Angel doesn't have global developmental delay from a cognitive standpoint?
A. He's very socially aware; he's interactive. He can gesture for his needs. He can understand commands, and that suggests that he does have communication skills. He just lacks speech.
(Respondent's Exhibit F, pages 25, 26, 29, 31, 33, 34, 41,
and 42)
Here, the opinions of the experts offered by the parties, as well as the other proof of record, have been carefully considered. So considered, it must be resolved that, while Ms. Donado suffered cardiopulmonary arrest during labor and delivery, and there is evidence to suggest Angel may have suffered oxygen deprivation during that time, the proof fails to support the conclusion that, more likely than not, any oxygen deprivation Angel may have suffered resulted in brain injury, or that he is permanently and substantially mentally and physically impaired. In so concluding, it is noted that, given the record, there is no reason to accept the views on causation expressed by
Dr. Abern, over those expressed by Dr. Duchowny, and that regardless of the cause, Angel is not permanently and substantially mentally and physically impaired.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the parties to, and the subject matter of, these proceedings. § 766.301, et seq, Fla. Stat.
The Florida Birth-Related Neurological Injury Compensation 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. § 766.303(1), Fla. Stat.
The injured "infant, her or 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. §§ 766.302(3), 766.303(2), 766.305(1), and 766.313, Fla. Stat. The Florida Birth-Related Neurological Injury Compensation Association, 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." § 766.305(3), Fla. Stat.
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. § 766.305(6), Fla. Stat. 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. §§ 766.304, 766.309, and 766.31, Fla. Stat.
In discharging this responsibility, the administrative law judge must make the following determination based upon the available evidence:
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).
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.
§ 766.309(1), Fla. Stat. 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." § 766.31(1), Fla. Stat.
Pertinent to this case, "birth-related neurological injury" is defined by Section 766.302(2), 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 postdelivery 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.
As the proponents of the issue, the burden rested on Petitioners to demonstrate that Angel suffered a "birth-related neurological injury." § 766.309(1)(a), Fla. Stat. See also
Balino v. Department of Health and Rehabilitative Services, 348 So. 2d 349, 350 (Fla. 1st DCA 1997)("[T]he burden of proof, apart from statute, is on the party asserting the affirmative issue before an administrative tribunal.")
Here, the proof failed to support the conclusion that, more likely than not, Angel suffered an "injury to the brain
. . . caused by oxygen deprivation . . . occurring in the course of labor, delivery, or resuscitation . . . which render[ed] . .
. [him] permanently and substantially mentally and physically impaired." Consequently, the record developed in this case failed to demonstrate that Angel suffered a "birth-related neurological injury," within the meaning of Section 766.302(2), and the claim is not compensable. §§ 766.302(2), 766.309(1), and 766.31(1), Fla. Stat. See also Florida Birth-Related Neurological Injury Compensation Association v. Florida Division of Administrative Hearings, 686 So. 2d 1349 (Fla. 1997)(The Plan is written in the conjunctive and can only be interpreted to require both substantial mental and substantial physical impairment.); Humana of Florida, Inc. v. McKaughan, 652 So. 2d 852, 859 (Fla. 5th DCA 1995)("[B]ecause the Plan . . . is a statutory substitute for common law rights and liabilities, it should be strictly constructed to include only those subjects clearly embraced within its terms."), approved, Florida Birth- Related Neurological Injury Compensation Association v.
McKaughan, 668 So. 2d 974, 979 (Fla. 1996).
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."
§ 766.309(2), Fla. Stat. Such an order constitutes final agency action subject to appellate court review. § 766.311(1), Fla.
Stat.
CONCLUSION
Based on the foregoing Findings of Fact and Conclusions of Law, it is
ORDERED that the claim for compensation filed by Juan Carlos Donado and Antonio Balbuena, as co-guardians of Rosa Donado, on behalf of Angel Balbuena, a minor, is dismissed with prejudice.
DONE AND ORDERED this 20th day of May, 2004, in Tallahassee, Leon County, Florida.
S
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 20th day of May, 2004.
ENDNOTES
1/ All citations are to Florida Statutes (2000) unless otherwise indicated.
2/ Respondents also offered an unsigned letter by Dr. Stuart Brown, dated February 18, 2002, that facially purported to be a report of independent medical examination. Little information was offered regarding who Dr. Brown rendered the report for, but it would appear the examination was done presuit under Section 766.106(6), Florida Statutes, on behalf of the health care providers. Petitioners objected to the exhibit based on the provisions of Sections 766.106(5) and (6)3, Florida Statutes.
Petitioners' objection based on the provisions of Section 766.106(6)3, Florida Statutes, is sustained, and Respondent's Exhibit G is not received into evidence.
3/ The Apgar scores assigned to Angel 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 of 0 through a maximum score of
As noted, at one minute, Angel's Apgar score totaled 4, with heart rate and color being graded at 2 each, and respiratory effort, muscle tone, and reflex irritability being graded at 0. At five and ten minutes, Angel's Apgar score totaled 5, with heart rate and color being graded at 2 each, respiratory effort being graded at 1, and muscle tone and reflex irritability being graded at 0.
4/ Angel's Neurologic Discharge Summary is dated February 17, 2001; however, he was not discharged until February 19, 2001.
5/ Dr. Abern was employed by Petitioners in late December 2002 or early January 2003, during the pendancy of the civil action, discussed supra.
COPIES FURNISHED:
(By certified mail)
Mary Margaret Schneider, Esquire Aronovitz Trial Lawyers
Museum Tower, Suite 2700
150 West Flagler Street Miami, Florida 33130
Steven R. Simon, Esquire Simon & Dondero, P.A.
Suntrust International Center, Suite 2110 One Southeast Third Avenue
Miami, Florida 33131
M. Mark Bajalia, Esquire
Volpe, Bajalia, Wickes, Rogerson & Galloway
1301 Riverplace Boulevard, Suite 1700
Jacksonville, Florida 32207
Kenney Shipley, Executive Director Florida Birth Related Neurological
Injury Compensation Association 1435 Piedmont Drive, East, Suite 101
Tallahassee, Florida 32308
Richard S. Friefeld, M.D. 16601 Northeast 19th Avenue
North Miami Beach, Florida 33162
Jose Abreu, M.D.
7150 West 20th Avenue, Suite 202
Hialeah, Florida 33016
Palmetto General Hospital 2001 West 68th Street Hialeah, Florida 33016
Ms. Charlene Willoughby Department of Health
4052 Bald Cypress Way, Bin C-75 Tallahassee, Florida 32399-3275
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 the original of a notice of appeal with the Agency Clerk of the Division of Administrative Hearings and a copy, accompanied by filing fees prescribed by law, with the appropriate District Court of Appeal. See Section 766.311, 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.
| Issue Date | Document | Summary |
|---|---|---|
| May 20, 2004 | DOAH Final Order | Proof failed to demonstrate that cause of infant`s impairment was brain injury caused by oxygen deprivation or that infant was permanently and substantially mentally and physically impaired. Claim denied. |
