Findings Of Fact Miracle Termidor was born on September 6, 2012, at Northwest Medical Center located in Margate, Florida. Miracle weighed 3,550 grams at birth. Donald Willis, M.D. (Dr. Willis), was requested by NICA to review the medical records for Miracle, to determine whether an injury occurred to the brain or spinal cord caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate post-delivery period. In a medical report dated July 7, 2016, Dr. Willis described his findings in part as follows: Vaginal delivery was complicated by a shoulder dystocia. There was only a 20 second delay from delivery of the head until delivery was completed. Birth weight was 7 pounds 13 oz’s or 3,550 grams. The baby was not depressed at birth. Apgar scores were 9/9. The baby’s left arm had decreased movement. Erb’s palsy was diagnosed. X-Rays showed no bone fractures. The newborn course was complicated only by the Erb’s palsy. Discharge was on DOL 2. No EEG’s or head imaging studies were done. In summary, delivery was complicated by a mild shoulder dystocia with only a 20 second delay in delivery. The baby was not depressed, but did suffer an Erb’s palsy. The newborn hospital course was otherwise uncomplicated. There was no apparent obstetrical event that resulted in loss of oxygen or mechanical trauma to the baby’s brain or spinal cord during labor, delivery or the immediate post delivery period. Dr. Willis reaffirmed his opinion in an affidavit dated August 5, 2016. NICA retained Michael S. Duchowny, M.D. (Dr. Duchowny), a pediatric neurologist, to examine Miracle and to review his medical records. Dr. Duchowny examined Miracle on June 15, 2016. In an affidavit dated August 8, 2016, Dr. Duchowny opined as follows: It is my opinion that Miracle’s neurological examination is significant for findings consistent with a left Erb’s palsy affecting the 5th and 6th cervical dermatomes. There is, however, no evidence of central nervous system involvement of the brain or spinal cord as the remainder of her neurological examination is within normal limits. Based on these findings, I am not recommending Miracle for compensation within the NICA program. A review of the file in this case reveals that there have been no expert opinions filed that are contrary to the opinion of Dr. Willis that there was no apparent obstetrical event that resulted in loss of oxygen or mechanical trauma to the baby's brain or spinal cord during labor, delivery or the immediate post-delivery period. Dr. Willis’ opinion is credited. There are no expert opinions filed that are contrary to Dr. Duchowny’s opinion that while Miracle’s examination is consistent with a left Erb’s palsy, there is no evidence of central nervous system involvement of the brain or spinal cord, and that the remainder of Miracle’s neurological exam is within normal limits. Dr. Duchowny’s opinion is credited.
The Issue At issue in this proceeding is whether Adam Joseph Balash, a minor, suffered an injury for which compensation should be awarded under the Florida Birth-Related Neurological Injury Compensation Plan.
Findings Of Fact Preliminary matters Evan Balash and Terry Balash are the parents and natural guardians of Adam Joseph Balash (Adam), a minor. Adam was born a live infant on November 5, 1991, at Palms West Hospital, a hospital located in Palm Beach County, Florida, and his birth weight was in excess of 2500 grams. The physicians providing obstetrical services during the birth of Adam were Robert Chaitin, M.D., and Ronald Ackerman, M.D., who were, at all times material hereto, participating physicians in the Florida Birth-Related Neurological Injury Compensation Plan (the Plan), as defined by Section 766.302(7), Florida Statutes. Mrs. Balash's antepartum course and Adam's birth Mrs. Balash's antepartum course was without apparent complication until November 5, 1991, when, with the fetus at 37 weeks gestation (estimated date of confinement November 20, 1991), she presented to her obstetrician/gynecologist. At the time, examination was reassuring with fetal movement and a fetal heart rate of 136 beats per minute; however, Mrs. Balash reported decreased fetal movement over the last few days. Consequently, she was referred to Palms West Hospital for a non- stress test (NST). Mrs. Balash presented to Palms West Hospital at or about 2:00 p.m. (1400 hours), November 5, 1991, and was placed on a fetal monitor for the NST at or about 2:04 p.m.3 Fetal heart rate (FHR) baseline was noted at 150 beats per minute and continued at that rate until about 2:25 p.m. when a period of bradycardia was shown to develop, down to approximately 90 beats per minute, and persist for approximately 5 minutes, with a return to baseline.4 Reassuringly, beat-to-beat variability and reactivity to Doppler were present, and no further episodes of bradycardia were noted during the course of Mrs. Balash's labor and delivery.5 Given the prolonged deceleration noted on the NST, Mrs. Balash was admitted to labor and delivery at 2:30 p.m. Vaginal examination revealed the cervix to be at 2-3 centimeters, effacement at 80 percent, and the fetus at station -2,6 with contractions at 1 to 2 minutes. Mrs. Balash complained of abdominal tenderness, and the abdomen palpated firm. No vaginal bleeding was noted. Dr. Chaitin was advised of Mrs. Balash's status, and intravenous (IV) fluids and lab work were ordered. At 3:00 p.m. the FHRs were noted as 140s, without accelerations, and at 3:20 p.m. vaginal examination revealed no change or progress. Dr. Chaitin was updated. At 3:34 p.m. Mrs. Balash was attended by Dr. Chaitin. His examination noted the fetus at station -3; however, dilation remained at 2 centimeters. The uterus was noted to be "rock hard without any relaxation," a presentation consistent with placental abruption. Consequently, Dr. Chaitin ruptured the membranes, yielding bright red amniotic fluid (further evidence of placental abruption).7 Internal fetal monitor was placed, revealing FHRs of 140s, with good variability and no decelerations.8 The fetus was noted to be in frank breech presentation. Given the evidence of fetal stress and probable placental abruption, Dr. Chaitin opted for a stat (immediate) cesarean section. Between 3:40 p.m. and 3:54 p.m., Mrs. Balash was prepared for surgery, anesthesia was started, and she was moved to the operating room. According to the labor and delivery summary, she was in the operating room at 3:55 p.m., the incision was made at 3:56 p.m., and Adam was delivered at 3:57 p.m., November 5, 1991. Pertinent to this case, the operative report reads as follows: . . . The uterus was noted to be rock hard in all quadrants. A low transverse incision was made with a scalpel. The uterine incision was extended bilaterally. The fetal breech was noted to be in frank breech position and with care, the butt was delivered and both arms were reduced appropriately. The fetal head was then removed, the baby was well bulb suctioned, and started crying extremely vigorously. [Infant dried and provided whiffs of oxygen, but no resuscitation required.] Cord was clamped, and neonatology present and baby evaluation was normal. A 6 pound, 12 ounce, baby boy was born with Apgar's 8/9. The cord ph was obtained which was 7.322 [normal]. The placenta was actively delivering, and was found to be 40% abrupted and was sent to pathology for evaluation. . . . The Apgar scores assigned to Adam 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, gag reflex, 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 Adam's Apgar score totalled 8, with heart rate, respiratory effort, muscle tone, and gag reflex being graded at 2 each, and color being graded at 0. At five minutes, his Apgar score totalled 9, with heart rate, respiratory effort, muscle tone, and gag reflex being graded at 2 each, and color being graded at 1. Such scores are grossly normal, as were Adam's newborn assessments, and he was admitted to the newborn nursery for routine care. (Petitioners' Exhibit 5, tabs 4 and 8). At approximately one hour of life (5:00 p.m.), Adam was observed to have turned dusky. One hundred percent oxygen via mask was applied, and Adam's color improved. Heart rate and respiratory rate were noted as stable. Adam was subsequently attended by Dr. Lerma Te, who noted nasal flaring, grunting, and retraction. Dr. Te's impression was "respiratory distress" and "rule out sepsis." Blood cultures were ordered, and intravenous Ampicillin and Claforan were started. Adam developed increasing oxygen requirements and at or about 6:40 p.m. he was intubated and assisted ventilation was begun. X-rays revealed "homogenous bilateral extensive ground glass appearance of the air bronchograms." Impression was that "[t]his either represents transient respiratory distress syndrome in the newborn or hyaline membrane disease."9 Given Adam's needs, he was transported to Good Samaritan Hospital, where he was admitted to the neonatal intensive care unit (NICU) at or about 10:25 p.m. Notably, notwithstanding his respiratory problems, Adam's neurological status remained essentially normal throughout his hospital stay. On November 20, 1991, Adam was discharged, in apparent good health, to his mother's care. His course at Good Samaritan Hospital noted no neurological problems, and is summarized on his discharge summary as follows: HISTORY: Mother is a 27 year old gravida 2, para 1, blood type 0 negative. Admitted at 37 weeks gestational age with abruptia placenta. Stat cesarean section was done and the baby was in breech position with Apgar score of eight and nine at one and five minutes respectively. Weight 2920 grams. The baby developed respiratory distress with increasing FI02 requirement. He was intubated and assisted ventilation started. Blood cultures were done. Intravenous Ampicillin and Claforan were started and the baby was transferred to Good Samaritan Hospital from Palm West. PHYSICAL EXAMINATION: Baby's weight 2920 grams, heart rate 156, respiratory rate 60, blood pressure 65/38. Premature 37 week male infant in respiratory distress. Head and Face: Anterior fontanelle flat. Oral cavity: No cleft plate noted. Chest: The baby is on assisted ventilation. Air entry heard both sides. Cardia: Heart sounds normal. Abdomen is soft. Umbilical cord has two vessels. Genitalia: Male. Extremities: No click at the hips. Central nervous system: Tone and reflexes equal on both sides. ASSESSMENT: Premature 37 weeks. Respiratory distress. Maternal complications, abruptia placenta. Cesarean section delivery. Suspected sepsis. Maternal history of herpes. HOSPITAL COURSE: Complete blood count, blood cultures x 7 were done. The baby continued on intravenous Ampicillin, endotracheal tube and cultures were sent for herpes. Umbilical catheter was inserted through the umbilicus about nine centimeters. He was started on Exosurf. The baby remained on assisted ventilation from 11/5 through 11/10/91 and was extubated on 11/10 and placed on Oxy-Hood. The baby was weaned from oxygen to room air by 11/18/91. The baby was also noted to be jaundiced and was started on photo therapy on 11/9/91 and was discontinued on 11/11/91 when the bilirubin declined. Echocardiogram done on 11/7/91 revealed moderate size patent ductus arteriosus and the baby was given Indocin and the patent ductus closed after the Indocin. The baby was on Ampicillin and Claforan for suspected sepsis and this was discontinued after a course of antibiotics of seven days. The baby was started on feedings on 11/18/91 and was advanced and IV's decreased. The baby tolerated adequate amounts of feedings and tolerated feeds well. The baby was discharged home at fifteen days of age when the baby weighed 6 lbs. 7.6 oz., was clinically stable and tolerating feedings well. DISCHARGE DIAGNOSIS: Premature 37 weeks male. Respiratory distress syndrome. Patent ductus arteriosus. Hyperbilirubinemia. Suspected sepsis. DISCHARGE PLAN: To be followed by Dr. Marineau in one week and Dr. Friedman for eye examination on 12/11/91. Brain stem auditory evoke potential examination to be done on 12/5/91 at Good Samaritan Hospital. Cranial ultrasound on 11/6 showed no evidence of [hydrocephalus or] intracranial bleeding. Adam's development Adam's early infancy was apparently unremarkable, and no problems were observed until approximately eight to ten months of age. At that time, developmental delay became evident and the parents reported their concerns to Adam's pediatrician, who referred him for neurologic consult at the Palm Beach Neurological Group.10 Adam was examined by a Dr. Mate, at the Palm Beach Neurological Group, in 1992; however, those observations are not of record. What is of record are the observations of Luis Bello-Espinosa, M.D. (Dr. Bello), another neurologist associated with the Palm Beach Neurological Group, who first examined Adam in April 1994. Dr. Bello describes Adam's presentation as consistent with severe cerebral palsy (profound brain dysfunction), that is characterized by spastic quadriparesis (an abnormal motor development affecting all four extremities) and mental retardation. Here, there is no dispute that Adam's impairments, mental and physical, are permanent and substantial. In an effort to identify the etiology of Adam's dysfunction, he was referred to Paul J. Benke, M.D., for genetic consultation. The results of Dr. Benke's first consultation were reported on November 2, 1993, as follows: DIAGNOSTIC IMPRESSION: Chromosome Anomaly. GENETIC COUNSELING: The developmental delay, now performing at 11-12 months, is probably related to the chromosome anomaly. It could not be determined today whether the neonatal problems played a role. One cell strain, the 20 deletion with 2 normal 7 chromosomes, is probably derivative from the dominant strain with the apparently balanced translocation. This would mean that the translocated #7 broke and lost most of the translocated #20, or far more likely, the whole chromosome was lost, the normal #7 was duplicated, and the 2 #7 chromosomes are derived from 1 parent. Blood was taken today to see if 1 parent is a translocation carrier. A skin biopsy, with a presumably higher proportion of 20 p- cells, would be required to determined (sic) why the translocated 7 was lost. Dr. Benke recommended follow-up studies. The results of Dr. Benke's follow-up studies were reported on October 1, 1994, as follows: This boy . . . [has] a mosaic chromosome abnormality . . . We did a skin biopsy months ago to determine the proportion of cells with a derivative chromosome 20, partial trisomy 7 and deletion 20. Most of the sample (29/30) cells had the balanced 7:20 translocation, with the deriviative (sic) 20 in just 3 percent. This suggests also that the balanced translocation was probably the first genetic lesion. Compounding conclusions of etiology for slow development is that a new balanced translocation leads to slow development and birth defects 7-10 per cent of the time. Also, the derivative 20 chromosome could be responsible since the neurons with this anomaly may function poorly. Also, he had a delay in his C-section of more than one hour when there was a demonstrable disruption of the placenta, associated with attendant neonatal problems. It is tough to say which of the factors is most responsible, but I think that the balanced translocation is the least important. Interestingly, children with chromosome 20 deletion are not particularly dysmorphic, but are delayed, and have some findings similar to those found in Adam. . . . In sum, Dr. Benke's conclusion was that Adam suffered a chromosonal abnormality known as a balanced translocation affecting approximately 3 percent of his cells. This genetic abnormality generally does not lead to any clinical problems; however, in 7 to 10 percent of the cases involving this type of translocation there may be genetic predisposition to decreased neurological development or birth (genetic) defect. The dispute regarding compensability Here, it is not subject to serious debate that the cause of Adam's neurologic impairment is associated with brain dysfunction or anomaly.11 What is at issue is the cause and timing (genesis) of that anomaly (encephalopathy)12 or, more pertinent to these proceedings, whether the proof demonstrates, more likely than not, that Adam's neurologic impairment resulted from an "injury to the brain . . . caused by oxygen deprivation13 . . . occurring in the course of labor, delivery, or resuscitation in the immediate post-delivery period," as opposed to some other genesis. Section 766.302(2), Florida Statutes. With regard to such issue, Petitioners contend that Adam suffered an hypoxic event, consequent to the stresses of labor (placental abruption and uterine hypertonicity), which caused a microscopic brain injury, and that such injury was the cause of Adam's neurologic impairment. In contrast, Respondent contends the proof is not consistent with hypoxic ischemic injury occurring during the course of childbirth, and, therefore, Adam's disorder must be attributable to some other etiology. Respondent's view of the proof has merit. The genesis of Adam's brain anomaly To address the genesis of Adam's brain anomaly, the parties offered selected medical records relating to Mrs. Balash's antepartum and intrapartum course, as well as for Adam's birth and subsequent development. Portions of those records have been addressed supra, and further salient portions will be addressed infra. The parties also offered the opinions of five physicians as to the likely cause of Adam's birth disorder. The physicians selected by Petitioners were Paul J. Benke, M.D., a board certified clinical and biochemical geneticist; Luis J. Bello, M.D., a board certified neurologist; and, Barry D. Chandler, M.D., a board certified neonatologist. The physicians offered by Respondent were Charles Kalstone, M.D., a board certified obstetrician and gynecologist; and Lance E. Wyble, M.D., a board certified neonatologist. The medical records and other documentary proof, as well as the testimony of the physicians offered by the parties, have been scrutinized. So considered, it must be concluded that the proof does not allow a conclusion to be drawn with any sense of confidence, that, more likely than not, Adam's brain anomaly was associated with an injury caused by oxygen deprivation during labor, delivery, or resuscitation in the immediate post- delivery period, as opposed to some other etiology.14 In reaching the foregoing conclusion, neither the evidence of placental abruption nor fetal stress during labor has been overlooked. However, while the presence of such factors could lead one to assume a connection and attribute Adam's anomaly to hypoxic ischemic encephalopathy, secondary to perinatal asphyxia, an examination of the clinical data and observations suggests that such would be a speculative and unlikely explanation for Adam's presentation. In so concluding, it is observed that Adam's course pre-delivery and post-delivery was inconsistent with hypoxic or ischemic injury having occurred during the course of birth. First, the evidence documenting fetal heart rate during the course of labor and delivery, particularly when compared with Adam's post-delivery presentation, does not support the conclusion that Adam suffered an acute intrapartum event that led to an hypoxic or ischemic injury. Notably, there was only one event of fetal heart rate deceleration and overall the monitoring tape was reassuring. Under such circumstances, it is unlikely that the partial abruption Mrs. Balash suffered adversely affected fetal oxygenation during labor and delivery. Further militating against the conclusion that Adam's anomaly was caused by oxygen deprivation during the course of labor and delivery are the numerous inconsistencies between Adam's presentation and the clinical findings one would expect had he suffered hypoxic ischemic encephalopathy, secondary to perinatal asphyxia, during that period. Notably, had such an event occurred, one would reasonably expect a severely depressed infant on delivery, with an absence of respiratory effort; a depressed cord pH; and the onset of seizure activity during the neonatal period. Here, Adam was alert and active on delivery, with good respiratory effort; his Apgars were normal, as were his newborn assessments; his cord pH was normal; and no seizure activity was noted in the neonatal period. Also of note, within approximately 24 hours of birth, Adam was administered a cranial ultrasound, which proved negative for hemorrhage and edema. Edema is a clinically anticipated consequence of neurological injury, and is anticipated within 6 to 12 hours of the event. Subsequent brain studies (MRIs), at or about 11 and 18 months of age, were also read as normal or, stated differently, failed to reveal global or bilateral injury generally associated with hypoxic ischemic encephalopathy. Finally, had Adam suffered an hypoxic ischemic event during birth, one would reasonably expect damage to multiple organ systems. Included would be the kidneys, bone marrow, the liver, and the heart. Here, Adam's creatine levels and urine output remained normal throughout the neonatal period, indicating that his kidneys were not subjected to an acute hypoxic event. Additionally, Adam evidenced no myocardial injury, and his bone marrow reflected no evidence of lymphocrytosis, which one would anticipate had there been an acute hypoxic event.15 Finally, Adam's first CBC (complete blood count) at Palms West Hospital indicated an extremely elevated level of nucleated red blood cells, which would be consistent with the presence of a chronic injury, as opposed to an acute insult. Given the proof, it cannot be concluded that, more likely than not, Adam's brain disorder and resulting neurologic impairment was associated with a brain injury caused by oxygen deprivation occurring in the course of labor, delivery, or resuscitation in the immediate post-delivery period. Notably, Adam's presentation at birth and his neonatal course were not consistent with an acutely acquired neurological injury, and it is improbable that he could have experienced an acute injury during labor and delivery without evidencing a single clinical symptom of such damage. Conversely, the existence of a prenatally acquired (predating labor and delivery) brain disorder (whether genetically or otherwise based) would be consistent with Adam's presentation at birth and during the neonatal period.
Findings Of Fact Zackary K. Farnum was born on August 11, 2008, at North Florida Regional Medical Center in Gainesville, Florida. Zackary weighed 3,620 grams at birth. Donald Willis, M.D. (Dr. Willis), was requested by NICA to review the medical records for Zackary to determine whether an injury occurred in the course of labor, delivery, or resuscitation in the immediate post-delivery period in the hospital due to oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate post-delivery period. Dr. Willis described his findings as follows in his medical report: In summary, labor was induced at term due to rupture of the membranes. A prolonged FHR deceleration, lasting about 4 minutes occurred at about five hours prior to birth. However, the baby was not depressed after birth with a normal Apgar score of 8 by five minutes and a normal cord blood pH of 7.29. The newborn hospital course was not complicated by multisystem organ failure, which is commonly seen with birth asphyxia. The baby had some initial difficult feeding and one episode of arching of the back was noted. Clinical findings were no [sic] substantial enough to require further evaluation, such as EEG or MRI. Overall, review of the medical records does not clearly identify a hypoxic event during labor or delivery that would have resulted in substantial brain injury. There was no apparent obstetrical event that resulted in loss of oxygen or mechanical trauma to the baby's brain during labor, delivery or the immediate post delivery period. NICA retained Michael S. Duchowny, M.D. (Dr. Duchowny), a pediatric neurologist, to examine Zackary and to review his medical records. Dr. Duchowny examined Zackary on May 21, 2014, and opined as follows in his medical report: In summary, Zackary's neurological examination reveals evidence of left-sided motor findings including left hemihypotrophy, left mild spastic weakness, and left hyperreflexia with a left Babinski sign. Despite these findings, he is able to accomplish most tasks reasonably well and is well-adjusted to his motor deficits. His cognitive functioning is appropriate for age, although he is behaviorally overactive and impulsive. His speech dysarthria is likely developmentally based. Medical records confirm the parental history of a difficult delivery. Zack's Apgar scores were 2 and 8 at 1 and 5 minutes and there was evidence of thick meconium. A tight nuchal cord was removed at birth. The neonatal course was subsequently benign. I am familiar with the Florida Birth-Related Neurological Injury Compensation Plan (the "Plan") and the standards imposed by the Plan for compensability of potential claims. Based upon my review of the medical records as described herein and in my report, and further based upon my evaluation of ZACKARY FARNUM, I have formed an opinion as to whether ZACKARY FARNUM qualifies for compensation under the plan. I regard Zack's motor difficulties as mild to moderate and his evaluation today does not provide evidence for a substantial mental impairment. I suspect that his right hemisphere stroke was acquired in utero but I have not had an opportunity to personally review the MR images. However, Zackary does not have a substantial mental impairment. I therefore believe that he should not be considered for inclusion within the NICA program. A review of the file in this case reveals that there have been no expert opinions filed that are contrary to the opinion of Dr. Willis that there was no apparent obstetrical event that resulted in loss of oxygen or mechanical trauma to the baby’s brain during labor, delivery or the immediate post delivery period. Dr. Willis’ opinion is credited. There are no contrary expert opinions filed that are contrary to Dr. Duchowny’s opinion that Zackary does not have a substantial mental or physical impairment. Dr. Duchowny’s opinion is credited.
Findings Of Fact Landon Pillow was born on November 29, 2010, at North Florida Regional Medical Center in Gainesville, Florida. Landon weighed 3,500 grams at birth. Donald Willis, M.D. (Dr. Willis), was requested by NICA to review the medical records for Landon, to determine whether an injury occurred in the course of labor, delivery, or resuscitation in the immediate post-delivery period in the hospital due to oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate post-delivery period. Dr. Willis described his findings as follows: In summary, there was a non-reassuring FHR pattern during labor. It is unlikely this resulted in any significant oxygen deprivation to the fetus, based on a cord blood gas pH > 7.0 and a normal newborn hospital course. Babies with birth related hypoxic brain injury will generally have multi-organ failures during the newborn period. There was no apparent obstetrical event that resulted in loss of oxygen or mechanical trauma to the baby’s brain during labor, delivery or the immediate post delivery period. Dr. Willis reviewed additional medical records on January 16, 2014, and, based on his review of those records, opined as follows: The additional records do not change any of my opinions concerning this case. The child suffered a brain injury, but the etiology is still undetermined. Based on the cord blood gas pH > 7 and a normal newborn hospital course after delivery, it does not seem reasonable to time the brain insult as birth related. NICA retained Michael S. Duchowny, M.D., to examine Landon and to review his medical records. Dr. Duchowny examined Landon on April 30, 2014, and gave the following opinion: In summary, Landon’s neurological examination today was extremely limited because of his postictal state. However, there were no specific focal or lateralizing findings despite the history of a left hemisphere infarct and porencephalic cavity. A review of medical records sent on February 26, 2014 confirms the history obtained today which revealed no evidence of a neurological injury to the brain or spinal cord due to oxygen deprivation or mechanical injury in the course of labor, delivery, or the immediate postnatal period. Landon’s cord blood pH was 7.25 and the base excess was -4. Both values are near-normal. Although the neurological examination was suboptimal, the history obtained today from the family and from medical records indicate that Landon’s neurological impairment was acquired prenatally. I therefore believe that he should not be considered for compensation within the NICA program. A review of the file in this case reveals that there have been no expert opinions filed that are contrary to the opinions of Dr. Willis and Dr. Duchowny that there was no obstetrical event that resulted in injury to the brain or spinal cord due to oxygen deprivation or mechanical injury during labor, delivery or the immediate post-delivery period. Their opinions are credited.
Findings Of Fact Ryan was born on September 4, 2015, at Central Florida Regional Hospital, in Sanford, Florida. The physician providing obstetric services and who was present at Ryan’s birth was Dr. David Teitelbaum. At the time of Ryan’s birth, Dr. Teitelbaum was a NICA participating physician. Respondent retained Donald Willis, M.D., an obstetrician specializing in maternal-fetal medicine, to review Ryan’s medical records and opine as to whether there was an injury to his brain or spinal cord that occurred in the course of labor, delivery, or resuscitation in the immediate post-delivery period due to oxygen deprivation or mechanical injury. In a report dated April 5, 2018, Dr. Willis concluded the following: In summary, labor was complicated by a non- reassuring FHR pattern requiring emergency Cesarean section delivery. The baby was depressed at birth with Apgar scores of 2/2/4. Resuscitation included chest compressions for 2 minutes, intubation and intravenous fluid bolus. Cooling protocol was initiated. The newborn hospital course was complicated by multi-system organ failures, including respiratory distress, hypotension, coagulopathy and elevated liver function studies. Despite the clinical findings of birth related hypoxia, only the initial EEG showed mild encephalopathy, which normalized. No abnormalities were reported on brain MRI’s after birth and at 6 months of age. There was a clinically apparent obstetrical event that resulted in oxygen deprivation during labor, delivery and continuing into the immediate post-delivery period. The oxygen deprivation would have been expected to result in some degree of brain injury. Attached to Respondent’s Unopposed Motion for Summary Final Order is the affidavit of Dr. Willis, dated June 27, 2018. In his affidavit, Dr. Willis opines, based on his education, training, and experience, and within a reasonable degree of medical probability, that there was a clinically apparent obstetrical event that resulted in oxygen deprivation during labor, delivery, and continuing into the post-delivery period. Respondent also retained Laufey Y. Sigurdardottir, M.D., a pediatric neurologist, to review Ryan’s medical records, conduct an Independent Medical Examination (IME), and opine as to whether he suffers from a permanent and substantial mental and physical impairment as a result of a birth-related neurological injury. Dr. Sigurdardottir reviewed the available medical records, obtained a full historical account from Ryan’s father and family members, and conducted an IME of Ryan on November 22, 2017. Dr. Sigurdardottir’s IME report provides, in part, as follows: Summary: Patient is a 2-year-old male with history of being born via an emergency C- section after normal uncomplicated pregnancy. Apgar scores were low: 2 whole body cooling was performed at Florida Hospital at 1 minute, 2 at 5 minutes, 4 at 10 minutes and 6 at 15 minutes. And patient had neurologic sequelae including a cognitive impairment autistic features. Despite having early motor delays, he is currently ambulatory. Result as to question 1: Ryan is found to have substantial delays in mental abilities but mild delays in motor abilities at this time. Result as to question 2: In review of available documents there is evidence of impairment consistent with a neurologic injury to the brain or spinal cord acquired due to oxygen deprivation. Result as to question 3: The prognosis for full motor recovery is good but mental recovery is unlikely and need for vast therapies to improve his language development and decrease autistic features is needed. His life expectancy is excellent. In light of evidence presented, I believe Ryan does not fulfill criteria of both substantial and mental and physical impairments at this time. I do not feel that Ryan should be included in the NICA program for that reason. Respondent’s Unopposed Motion for Summary Final Order also relies upon the attached affidavit of Dr. Sigurdardottir, dated June 25, 2018. In her affidavit, she opines, based upon her education, training and experience, and to a reasonable degree of medical probability, that Ryan “has substantial delays in mental abilities,” however, “he has only mild delays in motor abilities.” A review of the file reveals no contrary evidence was presented to refute the findings and opinions of Dr. Willis and Dr. Sigurdardottir. Their unrefuted opinions are credited.
Findings Of Fact Melina Antunes was born on August 27, 2015, at Florida Hospital, located in Orlando, Florida. Melina weighed in excess of 2,500 grams at birth. Donald Willis, M.D. (Dr. Willis), was requested by NICA to review the medical records for Melina. In a medical report dated December 12, 2016, Dr. Willis summarized his findings and opined in pertinent part as follows: In summary, induction of labor was complicated by a spontaneous uterine rupture. The baby and placenta were expelled into the maternal abdomen. The baby was depressed at birth with low Apgar scores and a cord blood gas consistent with acidosis (pH 6.65). MRI was consistent with HIE. There was an apparent obstetrical event (uterine rupture) that resulted in loss of oxygen to the baby’s brain during labor, delivery, and continuing into the immediate post delivery period. The oxygen deprivation resulted in brain injury. NICA retained Laufey Y. Sigurdardottir, M.D. (Dr. Sigurdardottir), a pediatric neurologist, to examine Melina and to review her medical records. Dr. Sigurdardottir examined Melina on February 15, 2017. In a medical report dated February 15, 2017, Dr. Sigurdardottir summarized her examination of Melina and opined in pertinent part as follows: Summary: Here we have a 17-month-old born after a sudden uterine rupture during active labor. The patient had neurologic depression at birth, significant acidosis with a pH of 6.6 and required active cooling as well as supportive medication for seizures in the neonatal period. She did have well documented injury on MRI but has made a remarkable recovery. Neurologic exam today, has mild abnormalities, but no standardized developmental testing is available for our review. Result as to question 1: Melina is not found to have substantial physical or mental impairment at this time. Results as to question 2: In review of available documents, Melina does have the clinical picture of an acute birth related hypoxic injury with both the clinical features of hypoxic encephalopathy and electrographic and MRI evidence to suggest hypoxic injury. Result as to question 3: The prognosis for full motor and mental recovery currently is excellent and her life expectancy is full. In light of her normal cognitive abilities and near normal neurologic exam, I do not feel that Melina should be included in the NICA program. If needed, I will be happy to answer additional questions or review further documentation of her developmental status. A review of the file in this case reveals that there have been no expert opinions filed that are contrary to the opinion of Dr. Willis that there was an apparent obstetrical event that resulted in loss of oxygen to the baby's brain during labor, delivery and the post-delivery period which resulted in brain injury. Dr. Willis’ opinion is credited. There are no expert opinions filed that are contrary to Dr. Sigurdardottir’s opinion that Melina does not have a substantial physical or mental impairment. Dr. Sigurdardottir’s opinion is credited.
The Issue Whether Jaxon Donald suffered a “birth-related neurological injury” as defined by section 766.302(2), Florida Statutes, for which compensation should be awarded under the Florida Birth-Related Neurological Injury Compensation Plan (“Plan”).
Findings Of Fact Linette Donald and Jeffrey L. Donald, Jr., are the parents and legal guardians of Jaxon. On September 30, 2017, Ms. Donald gave birth to Jaxon, a single gestation of 38 weeks, at Winnie Palmer Hospital a/k/a Orlando Health, Inc. (“Hospital”). Natalie Munoz-Sievert, M.D., provided obstetrical services and delivered Jaxon. It is undisputed that Dr. Munoz-Sievert was a participating physician in the Plan at the time of the delivery. Jaxon’s delivery, a spontaneous vaginal birth at 38 weeks gestational labor, was not complicated. Jaxon weighed 3,288 grams, was vigorous, and needed no resuscitation. His APGAR scores, which are used to determine if a baby needs resuscitation and if there is a risk of oxygen deprivation, were normal—eight at one minute and nine at five minutes. Scores above seven are considered normal. Jaxon needed no resuscitation after birth. Upon being transferred to the newborn nursery, Jaxon was clinically stable with no particular problems. The Hospital discharged Jaxon home in good condition with an uneventful newborn course at the Hospital. In support of their claim, Petitioners presented the testimony of Ms. Donald and two of her sisters. Petitioners also introduced medical records, including letters from two of Jaxon’s treating physicians. Ms. Donald testified about the labor, delivery, and Jaxon’s medical conditions. Although her prenatal records showed no particular signs of problems during her pregnancy, she explained why she believed Jaxon may have suffered a compensable birth-related neurological injury. Ms. Donald went into labor the evening of September 29, 2017. She went to the Hospital the next morning around 5:00 a.m. She waited in the lobby and an adjacent restroom for almost seven hours because there were no rooms available. During that period of time, she was not hooked up to a fetal monitor. Around 11:58 p.m., the Hospital admitted her and hooked her up to a fetal monitor, which indicated no fetal distress or abnormality. Ms. Donald felt the need to push immediately and, according to her, the nurse held the baby in until the doctor arrived. Ms. Donald delivered Jaxon at 12:42 p.m. Ms. Donald testified that Jaxon was blue after the delivery and that the Hospital placed him under a warmer. She said that the records indicated nasal flaring, which she believed showed respiratory distress. She testified that Jaxon was lethargic, sleepy, and had trouble feeding. Although she did not believe Jaxon was acting normal, the Hospital staff reassured her that he was fine. About 10 days after the delivery, she had to bring Jaxon back to the Hospital because he was not eating. Ultimately, Jaxon had a feeding tube inserted in August 2019. Ms. Donald testified that Jaxon is currently behind developmentally, both physically and emotionally. At about 18 months old, Jaxon underwent an MRI that showed he suffered a hypoxic ischemic event or low oxygen event that affected his brain. She believes the event could have occurred while she labored in the emergency room prior to being admitted and that the Hospital missed it due to a lack of fetal monitoring during that time. Jaxon is in occupational and speech therapy, as he currently only says five words. He also does not regulate his emotions like a normal child. Ms. Donald’s sisters, Ms. Perez and Ms. Rosado, also testified. Both were present at the Hospital and have spent time with Jaxon since his birth. They testified that Jaxon was lethargic at the Hospital, did not move much, and acted abnormally. Ms. Perez noted that Jaxon felt limp when she held him. Both stated that Jaxon is not where he should be developmentally. He has temper tantrums that last hours, cannot differentiate between yes and no, and says few words that only the family can understand. Neither sister believes Jaxon is where he should be developmentally at three years old. Samer Khaznadar, M.D., Jaxon’s pediatrician, prepared a letter indicating that, based on the medical records, Jaxon qualified for NICA benefits because he was diagnosed with Erb’s Paralysis due to a birth injury, has used a feeding tube, was diagnosed with mild cerebral palsy, wears an AFO,2 and is delayed. Dr. Khaznadar did not testify at the hearing, however, so he never expounded upon the medical bases for his statements, whether an oxygen deprivation event may have occurred during labor, delivery, or the 2 The record is silent as to the definition of an AFO. However, it appears to be an “ankle-foot orthosis” or brace “used to control instabilities in the lower limb by maintaining proper alignment and controlling motion. It is most often used with patients suffering from neurological or orthopedic conditions such as stroke, multiple sclerosis, cerebral palsy, fractures, sprains and arthritis.” Scheck & Siress, Plastic Ankle Foot Orthosis (AFO), available at https://www.scheckandsiress.com/patient-information/care-and-use-of-your- device/plastic-afo-ankle-foot-orthosis/ (last visited Sep. 4, 2020). immediate period thereafter, or whether Jaxon’s injuries constitute permanent and substantial mental and physical impairment. Murtuza Kothawala, M.D., Jaxon’s neurologist, also prepared a letter. He initially evaluated Jaxon for left upper extremity weakness in May 2018. When Jaxon was 18 months old in March 2020, he underwent an MRI that showed significant abnormality in his brain. Jaxon was diagnosed with left hemiplegic cerebral palsy, decreased muscle tone, and developmental delay, which are suggestive of a hypoxic low oxygen ischemic injury that might have happened around the perinatal period. However, Dr. Kothawala noted that determining the exact timing of the injury was impossible based only on the MRI report. He also confirmed that the Hospital’s medical records indicated a normal delivery with normal APGAR scores. Dr. Kothawala noted that Jaxon’s diagnoses impact him physically and interfere with his intellectual stamina as well as his ability to stay on task. He confirmed that accommodations would be needed so Jaxon could succeed academically. However, Dr. Kothawala did not opine that Jaxon suffers from permanent and substantial mental and physical impairment. He also did not testify at the hearing so as to explain the issues concerning the timing of the event that caused Jaxon’s injuries or whether they constitute permanent and substantial mental and physical impairment. NICA presented the testimony of two medical experts—Dr. Willis, a board-certified obstetrician, and Dr. Luis-Espinosa, a children’s neurologist who conducted an independent medical examination (“IME”) of Jaxon. After reviewing all of the medical records, Dr. Willis opined to a reasonable degree of medical certainty that Jaxon did not suffer an injury to the spinal cord or brain caused by oxygen deprivation during labor, delivery, or resuscitation in the immediate post-delivery period. Dr. Willis explained that the medical records indicated a normal, uncomplicated delivery and an uneventful newborn course at the Hospital. Jaxon’s fetal heart rate tracings were normal before and during the delivery, there was no indication of fetal distress during labor and delivery, his APGAR scores were normal, and he needed no resuscitation. Dr. Willis acknowledged that the medical records showed that Jaxon had problems with decreased muscle strength in the left arm and that the MRI showed findings that could be related to an oxygen deprivation event and brain injury. He also recognized that the medical records indicated Jaxon suffered from Erb’s Palsy, i.e., an injury to the brachial plexus that commonly occurs when a baby’s neck is stretched during a difficult delivery, but stated both that such an injury is not an injury to the brain or spinal cord itself and that the medical records confirmed an uncomplicated delivery. On cross examination, Petitioners asked whether the records could have missed an oxygen deprivation event while Ms. Donald was not hooked up to a fetal monitor before admission to the Hospital. Dr. Willis did not think so. He explained that, had such an oxygen deprivation event occurred that was sufficient to cause brain or spinal cord injury, the fetal distress would have been evident once the monitor was hooked up. Further, Jaxon’s other organ systems would likely have failed within a day or two of the delivery had such an event occurred, including seizures, respiratory distress requiring use of a ventilator, or renal failure. But, none of that occurred. Petitioners also asked whether Jaxon’s symptoms at birth—i.e., appearing blue and pale, nasal flaring, sleepiness, being floppy or low muscle tone, and difficulty feeding—were signs of an oxygen deprivation event. Dr. Willis explained that being blue and pale at one minute is normal. However, he acknowledged that some of the other symptoms could be evidence of a minor degree of brain injury due to a lesser degree of oxygen deprivation. In that scenario, the baby would not have all of the multi-organ failures he previously described. Dr. Willis testified, however, that such an event, even if it happened, would be outside the realm of NICA because the injury is not significant enough. Dr. Luis-Espinosa conducted an IME on Jaxon in December 2019. Based on his review of the medical records, the MRI report, and the IME, Dr. Luis-Espinosa opined to a reasonable degree of medical certainty that Jaxon most likely suffered a stroke in utero during the second or third trimester. Dr. Luis-Espinosa confirmed that the stroke caused Jaxon to suffer from cerebral palsy or spastic weakness in his left leg and arm. Dr. Luis- Espinosa did not believe that the stroke occurred during labor, delivery, or the immediate period thereafter because there were no clinical signs of stress during the delivery and Jaxon’s evolution post-birth was consistent with a normal, event-free birth. Dr. Luis-Espinosa confirmed that the cerebral palsy from which Jaxon suffers constitutes a permanent and substantial physical impairment. However, Dr. Luis-Espinosa does not believe that the impairment was caused by oxygen deprivation or a mechanical injury to the brain or spinal cord. Dr. Luis-Espinosa also opined to a reasonable degree of medical certainty that Jaxon does not suffer from a permanent and substantial mental impairment. During the IME, Dr. Luis-Espinosa found Jaxon to be cognitively behaving appropriately for his age. On cross examination, Petitioners asked whether Jaxon could have suffered from oxygen deprivation based on his appearing blue at birth and nasal flaring. Dr. Luis-Espinosa testified that Jaxon would have suffered from multi-organ failures had an oxygen deprivation event occurred. And, because oxygen deprivation affects both sides of the brain, Dr. Luis-Espinosa explained that such an event would not typically cause an injury to only one side of the body, such as Jaxon’s left-sided weakness. Dr. Luis-Espinosa acknowledged that his opinion as to mental impairment was only based on Jaxon’s state at the time of the IME. Based on the weight of the credible evidence, the evidence did not establish that Jaxon more likely than not suffered an injury to his brain or spinal cord due to oxygen deprivation or a mechanical injury during labor, delivery, or resuscitation in the immediate post-delivery period, which rendered him permanently and substantially physically and mentally impaired. The medical records indicated an uncomplicated delivery, normal APGAR scores, and no need for resuscitation. Dr. Willis and Dr. Luis- Espinosa opined to a reasonable degree of medical certainty that Jaxon did not suffer an oxygen deprivation event or one that occurred during labor, delivery, or the immediate period thereafter, but instead most likely suffered from a stroke in utero earlier in the pregnancy. They both offered specific, credible reasons to support those opinions. The letters from Jaxon’s treating physicians and Dr. Willis’s testimony on cross examination at best showed that a minor oxygen deprivation event could have occurred during the pre- admission period in the Hospital. However, that is insufficient to prove that such an event more likely than not occurred, particularly given the credible and unrebutted testimony of NICA’s two medical experts. Although it is undisputed that Jaxon suffers from a permanent and substantial physical impairment, the weight of the credible evidence did not establish that he suffers from a permanent and substantial mental impairment or that any impairment was caused by oxygen deprivation or a mechanical injury occurring during the course of labor, delivery, or resuscitation in the immediate post-delivery period. Petitioners’ witnesses offered credible testimony that Jaxon appears to be delayed mentally, does not speak enough for a child who is almost three years old, and does not act accordingly for his age. However, that lay testimony is insufficient to rebut the credible and unrebutted testimony of Dr. Luis-Espinosa that Jaxon showed no signs of mental impairment during the IME and that his physical impairment did not appear to be caused by an oxygen deprivation event.
Findings Of Fact Jinger-Anne Nobles was born on February 14, 2011, at Leesburg Regional Medical Center located in Leesburg, Florida. Jinger-Anne weighed in excess of 2,500 grams at birth. Donald Willis, M.D. (Dr. Willis), was requested by NICA to review the medical records for Jinger-Anne. In a medical report dated July 14, 2014, Dr. Willis opined as follows: I have reviewed the medical records for the above individual. The mother, Katherine Johnson, was a 26 year old G4 P2 with no significant prenatal problems. The mother presented to the hospital in early labor at 38 weeks gestational age. Antibiotics were given during labor for a positive vaginal culture for Group B Streptococcus. Amniotic membranes were ruptured with clear fluid. Fetal heart rate (FHR) monitor tracing during labor was reviewed. Baseline heart rate was 135 bpm with normal variability. There was no fetal distress during labor. Spontaneous vaginal delivery was uncomplicated. Birth weight was 2,890 grams. Apgar scores were 8/9. The newborn was not depressed. No resuscitation was required. The baby was taken to the nursery and stated to be in stable condition. Newborn hospital course was uncomplicated. The baby was re-admitted to the hospital twice during the first two weeks after birth. The first was two days after newborn hospital discharge. This admission was for elevated bilirubin level. The second was for choking and vomiting with possible cyanosis. No etiology was discovered and the baby was discharged home. In summary, the baby was delivered at term by spontaneous and uncomplicated vaginal birth. There was no fetal distress during labor. The newborn was not depressed and had a normal hospital course. There was no apparent obstetrical event that resulted in loss of oxygen or mechanical trauma to the baby’s brain during labor, delivery, or the immediate post delivery period. Dr. Willis reaffirmed his opinion in an affidavit dated December 29, 2014. NICA retained Michael S. Duchowny, M.D. (Dr. Duchowny), a pediatric neurologist, to examine Jinger-Anne and to review her medical records. Dr. Duchowny examined Jinger-Anne on October 1, 2014. In an affidavit dated December 22, 2014, regarding his independent medical examination of Jinger-Anne, Dr. Duchowny opined as follows: In summary, Jinger-Anne’s examination reveals findings consistent with a substantial mental and motor impairment. She evidences spastic quadriparesis, microcephaly, cortical visual impairment, optic nerve atrophy, no evidence of receptive or expressive language development, and generalized hyperreflexia. I have had an opportunity to review medical records sent on May 21, 2014. They document the pre and perinatal history and provide evidence of hyperbilirubinemia, but only to a level of 15. Jinger-Anne’s mother had presented to the hospital in early labor and had artificial rupture of membranes. Her mother had a postpartum tubal ligation. Jinger-Anne’s Apgar scores were 8 and 9 at 1 and 5 minutes and her birth weight was 6 pounds 6 ounces. Cord blood gases were not drawn and apart from hyperbilirubinemia, her postnatal course was uncomplicated. Her readmission on February 18 documented a rapid rise in bilirubin, reaching a peak level of 15.4. She was also diagnosed with an acute life-threatening event which after evaluation was believed to be caused by gastro esophageal reflux. I have not yet received either of the MRI scans. Although Jinger-Anne’s course would be extremely atypical of kernicterus as most affected individuals have normal cognitive status and present with findings consistent with athetotic cerebral palsy, I believe it is prudent to review the MR images in this case before making a final recommendation with regard to consideration for acceptance into the NICA program. ADDENDUM: I have reviewed the brain MR images obtained on July 8, 2011. The study reveals no significant abnormalities. Of note, the basal ganglia and thalami are normal. The study findings support my initial impression that Jinger-Anne’s neurological problems did not result from hyperbilirubinemia, mechanical injury or oxygen deprivation acquired in the course of labor, delivery or the immediate post- delivery period. A review of the file in this case reveals that there have been no expert opinions filed that are contrary to the opinion of Dr. Willis that there was no apparent obstetrical event that resulted in loss of oxygen or mechanical trauma to the baby's brain during labor, delivery, or the immediate post- delivery period. Dr. Willis’ opinion is credited. There are no expert opinions filed that are contrary to Dr. Duchowny’s opinion that although Jinger-Anne’s examination reveals findings consistent with a substantial mental and motor impairment, her neurological problems did not result from hyperbilirubinemia, mechanical injury or oxygen deprivation acquired in the course of labor, delivery or the immediate post-delivery period. Dr. Duchowny’s opinion is credited.
