Findings Of Fact Marshall was born on June 9, 2016, at Holmes Regional. Marshall was a child born of a single gestation, weighing 2,736 grams. NICA retained Donald Willis, M.D., an obstetrician specializing in maternal-fetal medicine, to review the medical records of Marshall and his mother, April Reynolds. Dr. Willis was asked to provide an opinion as to whether there was a brain or spinal cord injury to Marshall due to either oxygen deprivation or mechanical injury that occurred in the course of labor, delivery, or resuscitation in the immediate postdelivery period in the hospital. Dr. Willis authored a report to NICA on or about September 24, 2018, which is incorporated into his affidavit dated October 12, 2018. In his report, Dr. Willis stated in part: The mother, April Reynolds . . . presented at 38 weeks with a complaint of decreased fetal movement for several days. Blood pressure was elevated at 151/105 and a diagnosis of pregnancy induced hypertension was made. Pregnancy was felt to be uncomplicated prior to this complaint. Fetal heart rate (FHR) monitor tracing was reviewed. The tracing begins about 2 hours prior to delivery. Baseline FHR was 145 bpm with decreased heart rate variability. The mother was not in labor. . . . A prolonged FHR deceleration to 60 bpm was described at about 20 minutes prior to delivery. Emergency Cesarean section delivery was done for fetal bradycardia. Birth weight was 2,736 grams. The baby was severely depressed at birth. Apgar scores were 0/0/0. Resuscitation required intubation and chest compressions. A heart rate was obtained at 11 minutes after birth. * * * Complete newborn hospital records were not available. However, available records indicate the baby died about 6 hours after birth. Death certificate listed the cause of death as cardiorespiratory arrest and severe perinatal depression. In summary, the mother presented with a several day history of decreased fetal movements. FHR tracing on admission showed decrease variability with terminal bradycardia. The mother was not in labor. Medical records are consistent with oxygen deprivation that occurred prior to delivery. The parties have not submitted any evidence contrary to Dr. Willis’s opinion, and his opinion is credited.
Findings Of Fact Andy was born on November 2, 2015, at Tampa General located in Tampa, Florida. Based on the available evidence, Alyssa J. Brown, M.D., was the delivering physician for Andy’s birth. Dr. Brown was a “participating physician” under the Plan at the time Andy was born. See § 766.302(7), Fla. Stat. Upon receiving the Petition, NICA retained Donald Willis, M.D., a board-certified obstetrician/gynecologist specializing in maternal-fetal medicine, as well as Laufey Y. Sigurdardottir, M.D., a pediatric neurologist, to review Andy’s medical condition. NICA sought to determine whether Andy suffered a “birth-related neurological injury” as defined in section 766.302(2). Specifically, NICA requested its medical experts opine whether Andy experienced an injury to the brain or spinal cord caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate post-delivery period; and, if so, whether this injury rendered Andy permanently and substantially mentally and physically impaired. Dr. Willis reviewed Andy’s medical records and described Andy’s birth as follows: [V]acuum assisted vaginal delivery at term resulted in a newborn with normal Apgar scores and a normal umbilical cord blood gas. [Andy] did not require resuscitation. Dr. Willis then opined: There was no apparent obstetrical event that would have resulted in loss of oxygen or mechanical trauma to the baby’s brain during labor, delivery or the immediate post delivery period. Dr. Sigurdardottir also reviewed Andy’s medical records, as well as conducted an independent medical exam of Andy on May 2, 2018. Dr. Sigurdardottir commented that “Andy is found to have substantial delays in motor and mental abilities. . . . [T]here is no evidence of impairment consistent with a neurologic injury to the brain or spinal cord acquired due to oxygen deprivation or mechanical injury.” Dr. Sigurdardottir further opined: In light of evidence presented, I believe Andy does fulfill criteria of a substantial mental and physical impairment at this time, but it is likely due to a genetic condition and not to be from birth related injury. I do not feel that Andy should be included in the NICA program. A review of the file reveals no contrary evidence to dispute the findings and opinions of Dr. Willis and Dr. Sigurdardottir. Their opinions are credible and persuasive. Based on the opinions and conclusions of Dr. Willis and Dr. Sigurdardottir, NICA determined that Petitioner’s claim was not compensable. NICA subsequently filed the Unopposed Motion for Summary Final Order asserting that Andy has not suffered a “birth-related neurological injury” as defined by section 766.302(2). Petitioners do not oppose NICA’s motion.
The Issue Whether Jackson White (Jackson) suffered a birth-related neurological injury, as defined by section 766.302(2), Florida Statutes; and, if so, how much compensation, if any, is awardable pursuant to section 766.31.
Findings Of Fact Jackson was born on August 1, 2014, at Bayfront, in St. Petersburg, Florida. Jackson was a single gestation, weighing over 2,500 grams at birth. Jose Prieto, M.D., was the physician who provided obstetric services at Jackson’s birth. Jackson’s mother, Megan White (Mrs. White), was admitted to Bayfront and her labor was thereafter induced with Pitocin. Her membranes were artificially ruptured 15 hours prior to delivery, with clear fluid present. Delivery was initially attempted vaginally; however, delivery was altered to Cesarean section due to late decelerations and failure to descend and dilate. The records reflect that fetal heart rate decelerations may also have been present. Jackson was delivered in a vertex presentation. Upon delivery, out of a possible score of 10, his Apgar scores were 5, 7, and 8 at one, five, and ten minutes, respectively. Of concern was that his score for “color” was 0 for the first five minutes of life. He was not pink, but rather blue or pale. Additionally, he was not actively responding, but merely grimacing, at the first minute of life. The medical records document that Jackson was experiencing respiratory distress with desaturation. Accordingly, he initially received bulb suctioning, drying, stimulation, and whiffs of oxygen. As he continued to have poor color and perfusion, with grunting and retractions, continuous positive airway pressure by mask was applied. While there was improvement in the oxygen saturation after doing so, Jackson continued to have respiratory distress. Within two hours of birth, Jackson was transferred and admitted to the Neonatal Intensive Care Unit at All Children’s Hospital (All Children’s) for further management. Upon admission to All Children’s, it was documented that his oxygen saturations ranged from 96 percent to 100 percent while utilizing a Continuous Positive Airway Pressure (CPAP) system. His physical examination revealed that he was alert, active, responsive and pink in color. Jackson’s neurologic evaluation upon admission to All Children’s revealed that he was alert, active and responsive with good tone for age; there was symmetrical movement of all four extremities; his reflexes were intact; and that his “[n]eurological examination is appropriate for the baby’s gestational age.” At All Children’s, several chest X-rays were obtained from August 1 through August 3, 2014. Ultimately, the scans revealed that Jackson had a left pneumothorax. Accordingly, the CPAP was discontinued and an “oxyhood was initiated for nitrogen wash out which was discontinued after 22 hours.” Concerned with possible sepsis, Jackson also received seven days of antibiotics. Jackson was discharged home on August 8, 2014. Jackson failed his newborn hearing screen and subsequently underwent repeated testing where he was found to have mild-to-moderate sensorineural hearing loss bilaterally. Jackson has been wearing hearing aids since six months of age. Respondent retained Donald Willis, M.D., who is board- certified in obstetrics, gynecology, and maternal-fetal medicine, to review the available medical records of Jackson and his mother, and opine as to whether there was an injury to Jackson’s brain or spinal cord that occurred in the course of labor, delivery, or resuscitation in the immediate postdelivery period due to oxygen deprivation or mechanical injury. In his report, dated July 26, 2018, Dr. Willis set forth the following, in pertinent part: The mother was admitted for induction of labor at term. Amniotic membranes were ruptured with clear fluid. Fetal heart rate (FHR) monitor tracing was not available for review. Cesarean section delivery was apparently done for failure to decent [sic], but NICU notes suggest fetal heart decelerations were also present. Birth weight was 3,630 grams. Apgar scores were 5/7/8. Respiratory distress was present after birth with poor color, grunting and retractions. Bag and Mask ventilation was required and the baby transferred to All Children’s Hospital for respiratory distress. Grunting and retractions continued at All Children’s Hospital. Chest X-Ray identified a left pneumothorax. 100% hood oxygen was started. Intubation was not required. Cultures were obtained to r/o sepsis and antibiotics given for 7 days. Bacterial and viral (HSV) cultures were negative. The newborn hearing screen was failed. No seizures occurred during the hospital stay. Head imaging studies were not done during the newborn hospital course. The baby was discharged home on DOL 8. Hearing evaluation subsequently diagnosed a sensorineural hearing loss. Genetic testing was negative for familial deafness genes. Developmental delay became a concern at about 10 months of age. Genetic evaluation, including microarray, Fragile-X and metabolic work/up was negative. MRI showed delayed myelination. Etiology was uncertain, but a statement indicated “a very subtle degree of remote insult could be considered.” Follow up MRI at 2 1/2 years of age found similar findings. Neurology evaluation gave a diagnosis of chronic static encephalopathy. MRI of the lumbar spine was normal. In summary, the baby had respiratory distress after Cesarean section delivery. Chest X-Ray identified a pneumothorax. Oxygen was given for respiratory distress, but the baby did not require intubation. No head imaging studies were done during the newborn hospital stay. There were no seizures. Sensorineural hearing loss was diagnosed. MRI for developmental delay showed only some delay in myelination. There was no apparent obstetrical event that resulted in oxygen deprivation or mechanical trauma to the brain or spinal cord during labor, delivery and the immediate post- delivery period. After authoring the initial report, Dr. Willis received a copy of the fetal heart rate monitoring strips. After reviewing the same, on August 30, 2018, he authored an addendum to his report, which provides, in full, as follows: The fetal heart rate (FHR) monitor tracing during labor was reviewed. The tracing begins at about 05:17 on 08/01/2014. The baseline FHR was normal at 130 bpm. Uterine contractions were about every 5 minutes. The FHR tracing at about one hour prior to delivery is somewhat difficult to interpret due to attempt to place a fetal scalp electrode (FSE). FHR tracing ends at about 21:18 with delivery about 30 minutes after monitor is discontinued. The FHR tracing just prior to removal of the monitor does not suggest fetal distress. Review of the FHR tracing does not change the opinions stated in the letter above, dated 7/26/2014. There was no apparent obstetrical event that would have resulted in oxygen deprivation sufficient to cause brain injury. Dr. Willis was deposed on May 20, 2019. At his deposition, Dr. Willis affirmed the factual findings and medical opinions in the above noted report. In support of his opinion that Jackson did not sustain an injury to his brain or spinal cord in the course of labor, delivery, or resuscitation in the immediate postdelivery period due to oxygen deprivation or mechanical injury, Dr. Willis credibly testified that: 1) Mrs. White’s amniotic membranes were ruptured with clear fluid; 2) the fetal heart rate tracing did not suggest fetal distress; 3) the Apgar scores, although initially low, quickly improved and were inconsistent with an infant that sustained oxygen deprivation or acidosis; 4) Jackson did not exhibit any seizure activity; 5) aside from failing his hearing screen, Jackson did not experience any other organ system failures; and 6) the available MRI reports are inconsistent with Jackson suffering a brain injury at the time of labor and delivery. On May 12, 2017, Jackson presented to Himali Renuka Jayakody, M.D., for a neurological examination. Dr. Jayakody’s office note documents that, “[d]evelopmentally, he had initial normal development but starting around 10 months when he started standing, he appeared very clumsy and was falling over a lot.” After conducting the examination, Dr. Jayakody’s assessment was that Jackson had developmental delay, sensorineural hearing loss, and chronic static encephalopathy. His note further documented that, “[a]part from signal abnormality suggestive of hypomyelination mostly affecting the posterior white matter on MRI, we have not identified any other abnormalities. Clinically, he does not seem to have a progressive disease and has always made improvement over time suggestive of static encephalopathy/cerebral palsy.” NICA also retained Laufey Y. Sigurdardottir, M.D., a pediatric neurologist, to review Jackson’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 Mrs. White, and conducted and IME on Jackson on August 24, 2018. In her IME report, Dr. Sigurdardottir set forth her factual findings and opinions, which have to be admitted in this matter as part of the stipulated evidentiary record. Her summary findings and opinions are as follows: Summary: Patient is a 4 year old with history of being born via stat C-section due to fetal distress. No clear evidence was present of a neonatal hypoxic ischemic encephalopathy but he has since been diagnosed with cerebral palsy with corresponding MRI findings. His delays are mild in nature. Result as to question 1: Jackson is not found to have substantial delays in motor and mental abilities. Result as to question 2: In review of available documents, there is evidence of fetal distress but no neonatal encephalopathy consistent with a neurologic injury to the brain or spinal cord acquired due to oxygen deprivation or mechanical injury is reported in neonatal period apart from failing newborn hearing screen. Result as to question 3: The prognosis for full motor and mental recovery is good and the life expectancy is full. In light of evidence presented, I believe Jackson does not fulfill criteria of a substantial mental and physical impairment at this time. Petitioner neither testified nor presented any testimony to refute the findings and opinions of Drs. Willis and Sigurdardottir. Their findings and opinions are credited.
Conclusions This cause came before the undersigned upon the parties’ Joint Motion to Submit Stipulated Factual Record in Lieu of a Contested Hearing (Joint Motion), which was granted on May 22, 2019, and the parties’ proposed final orders.
Other Judicial Opinions Review of a final order of an administrative law judge shall be by appeal to the District Court of Appeal pursuant to section 766.311(1), Florida Statutes. Review proceedings are governed by the Florida Rules of Appellate Procedure. Such proceedings are commenced by filing the original notice of administrative appeal with the agency clerk of the Division of Administrative Hearings within 30 days of rendition of the order to be reviewed, and a copy, accompanied by filing fees prescribed by law, with the clerk of the appropriate District Court of Appeal. See § 766.311(1), Fla. Stat., and Fla. Birth-Related Neurological Injury Comp. Ass'n v. Carreras, 598 So. 2d 299 (Fla. 1st DCA 1992).
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.
Findings Of Fact Aydrian Portuondo was born on October 16, 2014, at South Miami Hospital in Coral Gables, Florida. Donald Willis, M.D. (Dr. Willis), was requested by NICA to review the medical records for Aydrian. In a report dated November 7, 2016, Dr. Willis described his findings in pertinent part as follows: Delivery was by spontaneous vaginal birth. Birth weight was 3,000 grams. Apgar scores were 4/8. The newborn was pale and Jaundice. After intubation for suctioning meconium, bag and mask ventilation was required for poor respiratory effort. Initial oxygen saturation was low at 70% and the baby was re-intubated and taken to the NICU. Generalized petechiae were noted on NICU evaluation. The liver and spleen were felt to be enlarged. Platelet count was only 14,000. TORCH infection was suspected. Urine culture for CMV was positive and CMV IgM antibody was also positive. Liver function studies were elevated. The newborn hearing test was failed. MRI on DOL 3 had findings consistent with congenital CMV infection with dilated lateral ventricles and multiple periventricular calcifications. Follow-up MRI’s continued to show similar findings with diffuse volume loss and findings consistent with congenital CMV. The baby was followed on an out-patient basis by Infectious Disease for congenital CMV infection. In summary, the pregnancy was complicated by fetal congenital CMV infection. Physical exam of the baby, laboratory testing and head imaging studies were consistent with this diagnosis. 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. The child’s brain injury would be consistent with congenital CMV infection and not a birth related hypoxic event. Dr. Willis reaffirmed his opinion in an affidavit dated November 17, 2016. A review of the file reveals that no contrary evidence was presented to dispute Dr. Willis’ finding 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.
The Issue At issue in this proceeding is whether Blane Earl Pearson, Jr., a minor, suffered an injury for which compensation should be awarded under the Florida Birth-Related Neurological Injury Compensation Plan.
Findings Of Fact Fundamental findings Petitioners, Blane Earl Pearson and Janet Pearson, are the parents and natural guardians of Blane Earl Pearson, Jr., a minor. Blane was born a live infant on October 5, 1998, at Shands at AHG (Alachua General Hospital), a hospital located in Gainesville, Florida, and his birth weight exceeded 2,500 grams. The physician providing obstetrical services at Blane's birth was Bradley Williams, M.D., who, at all times material hereto, was a "participating physician" in the Florida Birth- Related Neurological Injury Compensation Plan, as defined by Section 766.302(7), Florida Statutes. Coverage under the Plan Pertinent to this case, coverage is afforded under the Plan for infants who suffer a "birth-related neurological injury," defined as an "injury to the brain . . . caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate post- delivery period in a hospital, which renders the infant permanently and substantially mentally and physically impaired." Sections 766.302(2) and 766.301(1)(a), Florida Statutes. Here, the parties have stipulated, and the proof otherwise demonstrates, that Blane is permanently and substantially mentally and physically impaired. What remains to resolve is whether Blane's impairment is related to an injury to the brain caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the hospital. Blane's birth At or about 6:30 a.m., October 5, 1998, Mrs. Pearson (with an estimated date of delivery of October 10, 1998, and the fetus at 39+ weeks gestation) presented to Alachua General Hospital for induction of labor. At the time, Mrs. Pearson's membranes were noted as intact, and no contractions or vaginal bleeding were observed. External fetal monitoring, which began at 6:41 a.m., revealed a reassuring fetal heart rate. Pitocin drip was started at 7:59 a.m., and by 9:19 a.m., Mrs. Pearson was experiencing irregular contractions. In the interim, external fetal monitoring revealed a reassuring fetal heart rate (in the 130 beat per minute range), with good reactivity and variability.3 Mrs. Pearson's labor progressed steadily, and at or about 11:50 a.m., vaginal examination revealed the cervix at 3 centimeters dilation, effacement at 80 percent, and the fetus at station -1. At that time, the membranes were artificially ruptured, with clear fluid noted, and Dr. Williams authorized an epidural anesthesia.4 Mrs. Pearson's labor continued to progress steadily, and at 1:04 p.m., with the cervix at 10 centimeters dilation, effacement at 100 percent, and the fetus at station +1, Dr. Williams was called and advised that Mrs. Pearson was "complete and wanting to push." Dr. Williams announced he was "on his way," arrived in the labor and delivery room at 1:18 p.m., and at 1:20 p.m., Blane was delivered spontaneously, without incident. On delivery, Blane was bulb-suctioned, accorded blowby oxygen, dried, and moved to a radiant warmer. Initial newborn assessment noted no apparent abnormalities. Apgar scores were recorded as 8 at one minute and 9 at five minutes. The Apgar scores assigned to Blane are a numeric expression of the condition of a newborn infant, and reflect the sum points gained on assessment of heart rate, respiratory effort, muscle tone, reflex irritability, and color, with each category being assigned a score ranging from the lowest score of 0 through a maximum score of 2. As noted, at one minute, Blane's Apgar score totaled 8, with heart rate, respiratory effort, muscle tone, and reflex irritability being graded at 2 each, and color being graded at 0. At five minutes, Blane's Apgar score totaled 9, with heart rate, respiratory effort, muscle tone, and reflex irritability again being graded at 2 each, and color now being graded at 1. Such score is considered good, and inconsistent with recent hypoxic insult or trauma. Following the initial newborn assessment, Blane was examined by Karen Dees, an advanced registered nurse practitioner (ARNP). On examination, Ms. Dees noted Blane as "active," and her physical examination as "unremarkable" or stated otherwise, within normal limits (WNL). Ms. Dees completed her examination at or about 1:45 p.m., and executed the standard orders for Blane's admission to the newborn nursery. Blane transitioned for a brief period with his mother in the labor and delivery room and was then transferred to the newborn nursery, where he apparently did well until 5:20 p.m., when he was noted with tachypnea (at a respiratory rate of 68), slight nasal flaring, and respirations that appeared irregular. Questionable circumoral cyanosis was noted, with quick return to pink. Blane was transported to the neonatal intensive care unit (NICU) for evaluation by NICU staff. At the time, he again evidenced circumoral cyanosis, as well as an apneic episode, and was provided blowby oxygen and stimulation, with quick return to pink. Blane was admitted to NICU (for further management and observation), and placed on monitors and under an oxyhood. Labs were ordered (BC, ABG, and CBC with differential), and antibiotics (ampicillen and gentamicin) were prescribed for suspected sepsis. During the late afternoon and early evening, Blane was noted with several more apneic episodes, followed by tachypnea. And, at 8:00 p.m., Blane was noted to exhibit extensioned extremities, hypotonia, weak grasp, and deep to shallow irregular non-labored respirations. At 9:00 p.m., Blane experienced a long apneic spell requiring stimulation. No obvious seizure activity was noted, but his eyes deviated to the left. The impression was apnea of unknown etiology, respiratory distress of unknown etiology, and possibly intraventricular hemorrhage (IVH), seizures, and hypocalcemia. The Plan was to continue antibiotics and to perform a cranial ultrasound (to rule out a bleed). The cranial ultrasound was done at 11:00 p.m., and read as follows: HISTORY: Apneic spells and possible seizure activity. Evaluation for intracranial hemorrhage in a full term, newborn infant. FINDINGS: The intracranial, supratentorial structures are well delineated and exhibit no apparent hemorrhage or mass effect. The ventricles are not enlarged. The posterior fossa structures are seen best sagittally and appear unremarkable. IMPRESSION: NO HEMORRHAGE IDENTIFIED During the ultrasound, Blane had another apneic episode, requiring ambu bagging. At 1:00 a.m., October 6, 1998, Blane was given phenobarbital for suspected seizure activity, and at 1:30 a.m., he was intubated and placed on a ventilator because of multiple apneic episodes. Later that morning, at or about 9:00 a.m., Blane was transferred to Shands Hospital at the University of Florida (Shands Hospital), a level 3 neonatal intensive care facility, where he remained until October 17, 1998, when he was discharged to his mother's care. While admitted to Shands Hospital, Blane underwent a number of studies to identify the cause of his difficulties (seizures/apnea). Among those studies was an EEG, as well as CT of the head, done on October 6, 1998. The EEG was read, as follows: IMPRESSION: This is an abnormal EEG because of the presence of sharp waves seen over the frontocentral and temporal regions. This is consistent with but not diagnostic of a seizure disorder. In addition, positive sharp waves are also noted over both temporal regions. This is consistent with a diagnosis of intraventricular hemorrhage or periventricular leukomalacia. The CT of the head was reported, as follows: The peripheral cortical areas in the ACA and MCA distributions bilaterally have markedly decreased attenuation and loss of cortical sulci. These changes are most pronounced on the right. There is no evidence for intracranial hemorrhage. There is no evidence of herniation at this time. The basal ganglia, thalamus, and cerebellum are intact. IMPRESSION: The peripheral cortical territories in the ACA and MCA artery distributions bilaterally have decreased attenuation and loss of cortical sulci. These changes are most pronounced on the right and are compatible with an anoxic brain injury. A head UMR study was obtained on October 7, 1998, and compared with the CT exam of October 6, 1998. The results were reported, as follows: FINDINGS: Cerebral M.R. study was obtained 10/7/98 and compared to the 10/6/98 CT exam. There is diffuse cytogenic edema which is comparable on the two studies and is not evolved. The edema corresponds to lateral cortical areas on the right side in the middle cerebral artery zone and involves the anterior suprasylvian, the anterior infrasylvian and basal ganglion region on the left side. This also appears to be involving much of the middle cerebral artery zone on the left side. The remainder of the brain has less edema or no edema. The T1-weighted images are hyperintense in the basal ganglion region on the right side, indicative of coagulative necrosis in blood products, but not distinct hematoma. The findings are compatible with perfusion defects in the middle cerebral artery zones bilaterally. They do not appear to correspond to areas of cortex to suggest trauma since the patient is recently delivered. The remainder of the examination is unremarkable. There is no midline shift or downward herniation. IMPRESSION: Evidence of diffuse cytogenic edema in the middle cerebral artery zones bilaterally as described above. Etiology is not apparent. Regarding the results of the scan, the attending neonatologist noted "CT scan . . . grossly abnormal -- [consistent with] . . . diffuse hypoxic/ischemic insult, of recent timing, although it is not possible to pin down the exact timing." Finally, at 7:57 a.m., October 15, 1998, Blane had a final CT of the head to reassess his cerebral edema. That exam was reported, as follows: COMPARISON: Continuous axial CT images were obtained of the brain. Those dated 10/15/98 are directly compared to prior dated 10/6/98. FINDINGS: Again seen is ischemic encephalopathy. Multiple vascular territories show areas of ischemia/infarct. The ischemic core now contains blood products and radiographic appearance consistent with coagulative necrosis. No hematoma is seen. When compared to prior images there is decreased edema with now visualization of the lateral ventricles. Decreased mass effect when compared to prior images is seen. IMPRESSION: Known ischemic encephalopathy with blood products now seen in the ischemic core. Decreased edema. Less mass effect. The cause and timing of Blane's brain injury To address the issue of whether Blane's brain injury was "caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate post-delivery period in a hospital," as required for coverage under the Plan, Petitioners offered medical records relating to Mrs. Pearson's antepartum and intrapartum course, as well as Blane's birth and subsequent development. (Petitioners' Exhibits 1 and 2). Portions of those records have been addressed supra, and other salient portions of those records will be addressed infra. Additionally, Petitioner Janet Pearson testified on her own behalf, and offered the testimony of Janet Luna (Mrs. Pearson's mother) and the deposition testimony of Laura Law (Mrs. Pearson's sister). Respondent offered the deposition testimony of Dr. Michael Duchowny, a physician board- certified in pediatric neurology, and Dr. Charles Kalstone, a physician board-certified in obstetrics and gynecology. As for the cause and timing of Blane's brain injury, it was Dr. Duchowny's opinion that the injury Blane suffered was, more likely than not, intrauterine acquired, and attributable to events which occurred prior to labor and delivery. In so concluding, Dr. Duchowny observed that contrary to what one would expect if Blane had suffered a recent neurological injury, his Apgar scores were good, his arterial blood gases were normal, and he required no assistance other than blowby oxygen. It was also Dr. Duchowny's opinion that Blane's brain injury was not caused by oxygen deprivation or mechanical injury. (Respondent's Exhibit 1, pages 25 and 26). As for the cause of Blane's injury, it was Dr. Duchowny's opinion that it was most likely associated with a stroke or series of strokes suffered late in term. (Respondent's Exhibit 1, pages 23 and 24). For similar reasons, Dr. Kalstone, like Dr. Duchowny, was of the opinion, based on his review of the medical records, including the fetal monitor strips, that Blane's presentation (during labor and delivery) was not consistent with a brain injury caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation. As for the cause, as well as the timing of Blane's injury, Dr. Kalstone deferred to others, such as a pediatric neurologist, who were more suited to address that issue. (Respondent's Exhibit 2, page 14). Petitioners did not offer any expert testimony to support their view that Blane's brain injury was occasioned by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate post- delivery period in the hospital. Petitioners did, however, offer the testimony of Petitioner Janet Pearson, Janet Luna and Laura Law on two matters: the actions of the nursing staff, which they perceived to be an effort to forestall Blane's delivery; and their opinions regarding Blane's condition on delivery. These matters, Petitioners believe, were not considered by Respondent's experts (because they were not contained within the medical records), and they contend such matters compel the conclusion that Blane's injury was occasioned by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate post-delivery period. With regard to the first matter, Petitioner Janet Pearson and her witnesses testified that a nurse gloved-up, placed her hand inside Mrs. Pearson's vagina, and placed her hand on Blane's head to forestall delivery until the doctor could arrive. Petitioners suggest the nurse's act was improper and may have resulted in injury to Blane; however, they offered no competent proof to support such contention. Indeed, the only testimony on the matter was given by Doctors Kalstone and Duchowny who observed that, under the circumstances of this case, the nurse's action was unlikely to have caused any injury to Blane. In this regard, Dr. Kalstone, responding to questions by counsel for Petitioners observed: Q. Let me ask you, Doctor, hypothetically, assuming that at sometime during the labor that Blane was manipulated by one or more nurses in such a fashion as to push his head back into or farther up the birth canal, assuming that type of manipulation, is that the type of motor force that could cause an injury? * * * If the nurses were trying to hold the baby in, so to speak, then I wouldn't expect it would cause significant damage like this baby has. The kinds of damage that that thing, that that kind of action can cause, although I've never seen it, would be if there was like intracranial hemorrhage that caused the problem, that is actual trauma, and its hard to traumatize a baby's head by pushing it back up, but that would be one mechanism, that if you caused an intracranial hemorrhage, so to speak, and I didn't see any evidence of that in the record, in the CT scan. There was nothing suspicious in the baby's records that I could tell that that was a brain hemorrhage, but that would be one possible mechanism that one at least would look for. And the other would be if that in some way can cause an oxygen deprivation, which I've never seen it . . . [do] that, again, I haven't seen this done that often, sometimes we intentionally push a baby's head up when the cord prolapses to keep them off the cord. There's a decrease in the fetal heart sometimes by reflex when you push on the baby's head, but it usually wouldn't cause brain damage or significant problem, and if it did, I would expect it, that the baby would come out in poor condition if this occurred right before the doctor arrived, but this baby was born with an APGAR of 8 and 9 at one and five minutes, which were normal, so I would think that if there was anything that the nurses did that caused the oxygen deprivation, that, first of all, I would think that would be unlikely that it would cause that, just what they could be able to do with their hands. And second of all, I would think it wouldn't have been the kind of thing that would have damaged the baby and then the baby came out without showing signs of being asphyxiated. [Respondent's Exhibit 2, pages 15-17]. Dr. Duchowny's opinions on the matter were strikingly similar to those of Dr. Kalstone. (Respondent's Exhibit 1, pages 20-22, 24, and 32). With regard to the second matter, Mrs. Pearson and her witnesses testified as to their observations regarding Blane's condition on delivery, which they contend supports an Apgar score substantially lower than the score recorded at birth.5 Petitioners also suggest that the Apgar scores recorded by the nurse were most likely inflated because of a "certain self- interest motive . . . , if, and in the event, that they indeed were pushing him back in, holding him, . . . to wait for the doctor to get there." (Petitioners' proposed final order, paragraph 28). Consequently, since Respondent's experts relied on the Apgar scores of record in rendering their opinions, Petitioners suggest their opinions should be rejected, and a conclusion drawn that Blane's injury was caused by oxygen deprivation that occurred during the course of labor, delivery, or resuscitation. Petitioners' contention is rejected. In rejecting Petitioners' contention, it is initially observed that, where, as here, there was no showing that the nursing staff acted improperly, or that their actions could reasonably cause injury to the infant, there was no compelling reason for fabrication. Moreover, following delivery, Blane was also examined by Ms. Dees, who discerned no apparent abnormality, and Blane's course in the newborn nursery did not raise any concern until approximately 4 hours of age. Under such circumstances, it is doubtful that Blane's initial Apgar scores were inflated by the nursing staff at delivery. Additionally, it is observed that, while Petitioners offered testimony which, if credited, might warrant a reassessment of Blane's Apgar scores, they failed to offer any expert testimony or other competent proof as to what that score would be. Consequently, any reassessment of Blane's Apgar scores would be founded on speculation. Finally, it is observed that the opinions of Doctors Duchowny and Kalstone were not predicted simply on Blane's Apgar scores. Rather, their opinion that Blane's injury was not caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation, was also premised on evidence which demonstrated that Blane's arterial blood gases were normal, he required no assistance at birth other than blowby oxygen, and the fetal monitor strips failed to reveal any event consistent with fetal compromise. Accordingly, it must be concluded that the proof failed to demonstrate that Blane suffered a "birth-related neurological injury" since the proof failed to demonstrate that, more likely than not, his impairments were associated with a brain or spinal cord injury caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate post-delivery period in the hospital.
Findings Of Fact Kathaileen F. Arbulu was born on April 27, 2013, at Osceola Regional Medical Center in Kissimmee, Florida. Donald Willis, M.D. (Dr. Willis), was requested by NICA to review the medical records for Kathaileen. In a report dated March 9, 2016, Dr. Willis described his findings in pertinent part as follows: The mother was admitted to the hospital at 38 weeks for induction of labor due to preeclampsia and a history of Gestational Diabetes. Fetal heart rate (FHR) monitor tracing during labor did not suggest fetal distress. Seizure activity occurred during the induction. Eclampsia was diagnosed and intravenous MgSO4 started for management. Cesarean section was done due to Eclampsia. The delivery was stated to be uncomplicated. Amniotic fluid was clear. There was a loose nucal cord. Birth weight was 4,210 grams or 9 lbs 4 oz’s. The baby was not depressed. Apgar scores were 8/8. The infant cried spontaneously at delivery. No resuscitation was required. The baby was given blow-by oxygen for two- minutes and then transferred to the nursery. 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. A review of the file reveals that no contrary evidence was presented to dispute Dr. Willis’ finding that Kathaileen’s injuries were not the result of oxygen deprivation or mechanical injury during labor, delivery, or the immediate post-delivery period. Dr. Willis’ opinion is credited.
Findings Of Fact Gianna was born on August 20, 2017, at Traditions Hospital, located in St. Lucie County, Florida. Donald Willis, M.D. (Dr. Willis), was requested by NICA to review the medical records for Gianna. In a medical report dated February 29, 2020, Dr. Willis summarized his findings and opined, in pertinent part, as follows: In summary, labor at term was complicated by an abnormal FHR tracing that required Cesarean section delivery. Umbilical cord blood gas pH of 7.04 would seem consistent [with] the FHR pattern prior to delivery. Although there was some acidosis at birth, cord pH and base excess were not substantial enough to likely result in significant brain injury. This would be consistent with Apgar scores of 9/9, suggesting no significant birth related depression or hypoxia. Head enlargement was noted at birth and head ultrasound within two hours of birth showed dilated ventricles, consistent with hydrocephaly. These findings were confirmed by subsequent MRI. It is most likely the brain injury occurred at some time in the prenatal period and not birth related. As stated above, the baby’s brain injury does not appear to be the result of oxygen deprivation or trauma during the birth process or immediate post delivery period. NICA retained Luis E. Bello-Espinosa, M.D. (Dr. Bello), a medical expert specializing in pediatric neurology, to examine Gianna and to review her medical records. Dr. Bello examined Gianna on February 25, 2020. In a medical report dated February 25, 2020, Dr. Bello summarized his examination of Gianna and opined, in pertinent part, as follows: Gianna is a 2 1/2 year old girl born at term via C- section noticed at immediately after birth to have severe megalencephaly, and clinical signs of severe increased intracranial pressure. An urgent head ultrasound demonstrated bilateral ventriculomegaly, right intraventricular hemorrhage, and suspicion of agenesis of the corpus callosum. MRI of brain at Miami Children’s hospital done on day 1 of life showed severe enlargement of the third and lateral ventricles. Transependymal flow of cerebrospinal fluid was seen around the lateral ventricles being worse in the left cerebral hemisphere and extending to a greater degree in the left occipital and parietal lobes. Extensive intraventicular hemorrhage is seen with large clot identified in the right later ventricle. Her subsequent course required 7-VP shunt related surgeries at Miami Children’s hospital but since she was discharged at 7-month of age she had not had any seizures [or] other neurological related events. Gianna’s neurological examination today revealed she still has enlarged head, as well as left sided hemiparesis with upper motor neuron signs, in addition to cognitive dysfunction and stereotypic behavior as seen in children with autism. She has a VP shunt in place, but no longer evidence of decompensated intracranial pressure. * * * In reviewing all the available documents, the evolution of her symptoms, the birth findings, the acute brain ultrasound and acute brain MRI changes, it is evident that Gianna clinical findings are the result of a prenatal condition, are not due to a birth injury, and not due to oxygen deprivation of the brain at birth. * * * Considering the clinical presentation, I do feel that there is no evidence to recommend Gianna is included in 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 it is unlikely that any significant oxygen deprivation occurred prior to the birth of Gianna. Dr. Willis’s opinion is credited. There are no expert opinions filed that are contrary to Dr. Bello’s opinion that Gianna should not be considered for inclusion in the NICA program. Dr. Bello’s opinion is credited. Petitioner, despite attending the April 23, 2020, telephonic status conference, and agreeing to the April 29, 2020, Joint Response to Scheduling Order, which states, in part, that “NICA is of the opinion that the issues can be resolved by Motion for Summary Final Order, which it intends to file in the near future[,]” has failed to respond to the Motion or the undersigned’s Order to Show Cause.
Findings Of Fact Elian O. Morales Galindo was born on October 27, 2012, at Winnie Palmer Hospital for Women and Babies located in Orlando, Florida. Elian weighed 3,849 grams at birth. Donald Willis, M.D. (Dr. Willis), was requested by NICA to review the medical records for Elian 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. Dr. Willis described his findings as follows in an affidavit dated January 14, 2015: It is my opinion, in summary, spontaneous vaginal delivery was complicated by nuchal cord x2 and avulsion of the cord during reduction for delivery. Despite a normal cord blood pH, the baby was depressed at birth and required bag and mask ventilation for six minutes. The baby recovered quickly and was on room air within 24-hours after delivery. The initial blood gas after birth had a base excess of -12, which is consistent with some degree of acidosis. Head ultrasound was normal. EEG, CT scan and MRI were not done during newborn hospital course. Avulsion of the umbilical cord can occur when a tight nuchal cord is being reduced to allow delivery. The only risk related to cord rupture is neonatal blood loss and resulting hypotension. The baby’s blood counts were normal with a Hematocrit of 47% which would suggest the baby did not have a significant blood loss at time [sic] or cord rupture. This does not appear to be a factor in the outcome. There was an apparent obstetrical event that resulted in some degree of oxygen loss during delivery and continuing into the immediate post-delivery period. This is based primarily on the low Apgar scores and an initial blood gas with a based excess of -12. I am unable to comment about oxygen deprivation during labor without review [sic] the FHR monitor tracing. No imaging studies were done during the newborn hospital course to determine if this oxygen deprivation caused any brain injury. Thereafter, I reviewed the additional medical records, which include the mother’s hospital course during labor and delivery, the fetal heart rate (FHR) tracing during labor and an emergency room visit for the mother at 7 weeks gestational age for nausea. The FHR tracing during labor was reviewed. The baseline FHR on admission was normal at 130 bpm with normal heart rate variability. The FHR monitor tracing does not suggest fetal distress during labor. Accordingly, it is my opinion that there was no obstetrical event that resulted in oxygen deprivation or brain injury to the baby during labor. NICA retained Raymond J. Fernandez, M.D. (Dr. Fernandez), a pediatric neurologist, to examine Elian and to review his medical records. Dr. Fernandez examined Elian on February 11, 2015. In the medical report attached to Respondent’s Supplemental Motion for Summary Final Order, Dr. Fernandez opined as follows: CONCLUSION: There is no evidence for substantial motor or physical impairment. Elian walked on time and gross and fine motor skills are improving at a steady pace based on history and this trend should continue. Expressive speech and receptive language development is delayed, but improving and this trend should continue. While speech and language delay is a predictor of later learning difficulty, he is improving and we do not have convincing evidence, at this time, for substantial mental impairment that will be permanent. There was transient physical depression immediately after birth and there was transient respiratory distress, but he improved within a reasonable period of time. There was no clear evidence for neonatal encephalopathy or multi-organ involvement. Therefore, there is no clear evidence in the record for brain or spinal cord injury during labor, delivery, or the immediate post delivery period of resuscitation. While Dr. Willis and Dr. Fernandez are of the same opinion that an obstetrical event causing oxygen deprivation did not occur during labor, Dr. Willis’ opinion is somewhat at odds with Dr. Fernandez’s opinion regarding whether an obstetrical event occurred that resulted in some degree of oxygen loss during delivery and continuing into the immediate post-delivery period. However, there are no opinions filed contrary to Dr. Fernandez's opinion that there is no evidence of substantial motor or physical impairment or convincing evidence at this time of substantial mental impairment that will be permanent. Dr. Fernandez’s opinion is 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.
