The Issue Compensability, to wit: Whether the injury claimed is a birth-related neurological injury and whether obstetrical services were delivered by a participating physician in the course of labor, delivery, or resuscitation in the immediate post-delivery period in the hospital. Whether notice was accorded the patient, as contemplated by Section 766.316, Florida Statutes, or whether the failure to give notice was excused because the patient had an emergency medical condition, as defined in Section 395.002 (8)(b), Florida Statutes, or the giving of notice was not practicable.
Findings Of Fact Latasha Williams Russell is the natural mother of Perry Russell, Jr. (Perry, Jr.). Perry Russell, Sr., is the natural father of Perry, Jr. Perry, Jr., was born a live infant on May 7, 2008. Perry, Jr., was born at Bay Medical Center, a licensed hospital located in Panama City, Florida. Perry, Jr.'s, birth weight was in excess of 2,500 grams. The physician providing obstetrical services at the time of Perry, Jr.'s, birth was Bryce Vincent Jackson. M.D. At all times material, Dr. Jackson was a participating physician in the Florida Birth-Related Neurological Injury Compensation Plan. Latasha Williams signed a Notice to Obstetric Patient (NICA notice form) stating that Bryce Vincent Jackson, M.D., is a "participating physician in the program" on November 20, 2007. Bay Medical Center acknowledged at hearing that it had never given pre-delivery notice of NICA participation/limitation to Ms. Williams. On May 7, 2008, Perry, Jr., suffered a brain injury caused by oxygen deprivation. As a result of the oxygen deprivation, Perry, Jr., was permanently and substantially mentally and physically impaired. Perry, Jr., subsequently died on October 8, 2008. Perry Jr.'s, death was caused by the brain injury resulting from the oxygen deprivation. The term, "resuscitation in the immediate postdelivery period" is not defined in the NICA Statute. §§ 766.301-766.316, Fla. Stat. Other Facts Found The term, "resuscitation in the immediate postdelivery period" is not uniformly defined in the medical community. Latasha Williams Russell was an obstetrical patient of Dr. Jackson at North Florida Obstetric and Gynecologic Center, beginning on November 20, 2007. Her expected delivery date was May 11, 2008. Labor began for Ms. Williams at approximately 0200 [2:00 a.m.] on May 7, 2008.5 At 0840 [8:40 a.m.], she was admitted to Bay Medical Center, experiencing active contractions every 2-3 minutes for 60-80 seconds, four centimeters dilated, with the baby 100 percent effaced and fetal heart rate of 135 with variability present. Accompanied by female family and friends, Ms. Williams was placed in a Labor/Delivery/Recovery/Post-Partum Room (LDRP), and prepped for delivery. Although her female support team varied a little in composition in the beginning of her hospitalization, at all times material, Ms. Williams' mother and sister and at least one other woman were present in the LDRP room with her. Ms. Williams' complete cervical dilation was reported at 1145 [11:45 a.m.]. At 1215 [12:15 p.m.], Dr. Jackson ruptured the membranes and found 3+ meconium-stained amniotic fluid. Meconium at 3+ would be of a putty-like consistency. 20. From 1220 [12:20 p.m.] to 1250 [12:50 p.m.], Ms. Williams pushed through her uterine contractions, and Perry, Jr.'s, fetal heart rate was sustained between 120 and 130 beats per minute through this period. At 12:50 p.m., Ms. Williams delivered Perry Russell, Jr., a live, 2605-gram boy, via normal spontaneous vaginal delivery, assisted by a right medial and lateral episiotomy performed by Dr. Jackson. Despite the episiotomy, Ms. Williams suffered a fourth-degree laceration, requiring repair. Dr. Jackson's narrative record reads: PROCEDURE PERFORMED: Normal spontaneous vaginal delivery on May 7, 2008. Right Medial and Lateral episiotomy. Fourth-degree laceration repair. PROCEDURE DESCRIPTION: The patient underwent a NSVD[6] at 1250 on May 7, 2008, over a right medial lateral episiotomy. She delivered a male infant that had Apgars[7] of 6 and 9, and weight equals 5 pounds plus 11.8 ounces (2606 g.) The amniotic fluid was 3+ meconium stained. The baby's airway was suctioned with a bulb syringe as well a [sic] #10 French pediatric suction cannula connected to the wall suction by intermittent suction technique prior to delivery of the thorax. The placenta delivered spontaneously and was found to be intact. There were three umbilical cord vessels. The placenta mass was also small. The uterine cavity was then manually explored and found to be intact with no retained products of conception. Post- delivery examination of the episiotomy site revealed an approximately 12mm inlet vertically oriented laceration into the rectal mucosa. The anal sphincter was intact. One carefully identified the proximal and distal end of the laceration and closed the defect with a 4-0 chromic suture in a continuous fashion. The second layer of closure was then done over the first layer, again using a 4-0 chromic suture in a continuous fashion. The remainder of the laceration was sutured in normal episiotomy repair fashion using 3-0 and 2-0 chromic sutures. Estimated blood loss was estimated at 250 mL. Anesthesia equaled epidural. The mother and baby were left in LDRP in good stable condition. (emphasis added). There is no further written evaluation of the child by Dr. Jackson, and he did not testify. Upon the foregoing obstetrician's record and the testimony of the mother, the grandmother, and an aunt who were present, it is found that Dr. Jackson suctioned Perry, Jr's, mouth by bulb and wall cannula while Perry, Jr.'s, head was out of the birth canal and his thorax remained inside, and then delivered the remainder of Perry, Jr.'s, body. Perry, Jr.'s, time of birth was recorded as 12:50 p.m. After delivering the whole of the baby,8 Dr. Jackson again suctioned him and "handed off" Perry, Jr., to one of two nurses, who took the baby to the LDRP crib/warmer and who examined and worked to stimulate him. The mother heard the baby cry when passed to the nurse. (Ex. K-522). Meanwhile, Dr. Jackson directed his primary attention to the repair of Ms. Williams' episiotomy tear. By all accounts, one or two nurses were present in the LDRP room at least until shortly before Dr. Jackson finished the episiotomy repair. At the LDRP's crib, a nurse bulb-suctioned Perry, Jr.'s, mouth and nose again (Ex. L-596, TR-74), but he would not suck her finger and was not very responsive to her vigorous stimulation by rubbing. She wiped him off and wrapped him in a swaddling blanket, but he still had meconium staining on his face and ears. Perry, Jr.'s, Apgar scores at one and five minutes were documented by one of the nurses as 6 and 9 as follows: Heart Rate Respiratory Rate Muscle Tone Reflex Irritability Skin Color Total 1 Min. 1 1 1 2 1 6 5 Min. 2 2 2 2 1 9 Out of a possible "10," or perfect Apgar score, Perry, Jr., improved from 6 to 9, in a four-minute period. The testifying medical experts, Dr. Berto Lopez (live and by deposition) and Dr. Donald C. Willis (by deposition only), agreed that these Apgar scores are inconsistent with a baby who has previous thereto suffered an injury to the brain. Entries by a nurse on a form entitled, "Possible Problems Typical of Age-Weight Categories," at 10 minutes post- birth and at 25 minutes post-birth, respectively, read as follows: [1:00 p.m.] [1:15 p.m.] (1300) (1315) Temperature 98.9R[9] 97.5AX[10] Pulse 140 140 Respiration Rate 60 52 Respiratory Pattern Unlabored Unlabored Nasal Flaring None None Expiratory Grunt None None Retractions None None Color Pink Pink Abdomen Normal Normal Cry Normal Normal Activity Normal Normal The foregoing nurse assessments did not include oxygen saturation of the blood, blood pressure, or assessment of acidosis in the arterial blood gases. If such assessments had been made at that point and if acidosis had been found, it would have been an indicator of an hypoxic event. The foregoing assessment form required that the nurses watch for asphyxia and meconium aspiration. None of the nurses' recorded assessments denote asphyxia, mechonium aspiration, hypoxia, or ischemia. "Hypoxia" denotes a low oxygen level in the blood. "Ischemia" occurs when there is not enough blood circulating in the body.11 If meconium gets below the baby's vocal cords and is aspirated into his lungs, there can be oxygen deprivation, possibly followed by meconium aspiration syndrome. Dr. Lopez testified that 10 percent of all babies are born with meconium, and of those 10 percent, perhaps five percent develop meconium aspiration syndrome. The foregoing nurse assessments required by the form are among the conditions that medical personnel look for, in an effort to determine whether or not a newborn is experiencing asphyxia, oxygen deprivation, or meconium aspiration syndrome. All of the foregoing recorded signs or symptoms existing at 10 minutes of life and 25 minutes of life suggest that Perry, Jr., had experienced no hypoxia, asphyxia, or meconium aspiration syndrome up to those points in time and that his transition from the uterus to the outside world had been successful. No party presented testimony by any medical personnel present at the labor or delivery, or present during the initial obstetrician and nurse resuscitations, already described, which occurred immediately after delivery. Dr. Berto Lopez faulted the sufficiency of the foregoing nurse assessments, maintained that they fall below recognized medical record-keeping standards, and are not the equivalent of a physician's evaluation of the child. The "Possible Problems Typical of Age-Weight Categories" form, itself, provided space for the nurses to periodically make, and record, new assessments at intervals at least four more times, but no further nurse assessments were recorded on this form after 1315 [1:15 p.m.], on May 7, 2008, and no further medical records of any kind were generated until 1412 [2:12 p.m.]. Nonetheless, Apgar scores and the 10-minute and 25-minute post- delivery nurse observations/assessments (see Finding of Fact 31) have not been shown to be other than the actual observations of the medical personnel at the times stated on them, and the medical experts testifying herein have considered those assessments, as well as the Apgar scores, in rendering their respective opinions. After Dr. Jackson completed the episiotomy repair, the family was left alone with the newborn in the LDRP. The baby was passed from woman to woman, each of whom examined and admired him. Hospital records next show that at 2:12 p.m., Perry, Jr., suffered a cardiopulmonary event, became apneic (ceased breathing), and required intubation, chest compressions, and administration of epinephrine. There is no documentation by any medical personnel of Perry, Jr.'s, condition between 1:15 p.m. and 2:12 p.m. Also, no party presented testimony by any medical personnel present during the resuscitative efforts hereafter described, which occurred at 2:12 p.m. Based on the time of Perry, Jr.'s, delivery recorded by Dr. Jackson (12:50 p.m.) Perry, Jr.'s, cardiopulmonary event at 2:12 p.m., occurred one hour and 22 minutes after his delivery at 12:50 p.m. Based on the time of the last nurse assessment as recorded on the "Possible Problems Typical of Age- Weight Categories" form (1:15 p.m.), Perry, Jr.'s, cardiopulmonary event at 2:12 p.m., occurred 57 minutes after the obstetrician and attending nurses had left him in the LDRP in what Dr. Jackson believed to be "good, stable" condition. Based on the testimony of the female relatives, the cardiopulmonary event at 2:12 p.m., occurred within 20-25 minutes of the time Dr. Jackson exited the LDRP room. The timing of precisely when Perry, Jr., became apneic is in dispute. Despite the foregoing health care professionals' records stating the cardiopulmonary event occurred at 2:12 p.m., Perry, Jr.'s, mother, grandmother, and aunt maintain that Perry, Jr., was continually struggling for breath while they were alone with him in the LDRP and that he ceased breathing within 20-25 minutes of Dr. Jackson's exiting the LDRP room. While these witnesses' testimony as to chronology of events and time elapsed is consistent with each other's testimony, they all base their time calculations on the recollection of the four women sequentially holding the baby for an estimated 4-5 minutes apiece as they passed him around, and they all concur that they were not sufficiently alarmed by his breathing on the day in question to immediately call for medical assistance. In challenging the medical personnel's recordation that the cardiopulmonary event occurred at 2:12 p.m., Petitioners put forth the premise that all notations in the medical records are misleading, because they had to have been written down subsequent to the events or conditions recorded. For instance, the family believes that 2:12 p.m., is when the cardiopulmonary event was recorded/charted, not when it occurred. This premise, that the medical notations were written down after the event recorded, is accepted, for what it is worth, because clearly, medical personnel cannot record events which have not yet taken place and cannot record them simultaneously with performing the medical procedures. However, the premise, by itself, does not establish either that the events recorded in the medical records did not ever occur or that those events occurred so far in advance of their being recorded as to prevent the records' content (including timing) from being credible. The accuracy of the family's testimony as to timing is also diminished by their not being medically trained and their testifying in retrospect, without any notes made contemporaneously with the events. Also, as might be expected, in the joy and excitement of holding a new family member, none of Petitioners' witnesses looked at a watch or clock to time events, and if the 2:12 p.m., cardiopulmonary event and subsequent events occurred somewhat before the times written down, then all the events recorded as occurring prior to Dr. Jackson exiting the LDRP room also must have occurred somewhat prior to the time stated in the records, so that the span of time from delivery until Perry, Jr., suffered the hypoxic event would still be about an hour and 22 minutes post- delivery and about 57 minutes after the delivery team exited the LDRP room, believing that Perry, Jr., had been stabilized. On the other hand, the consistent testimony of the mother, grandmother, and aunt that after they were alone with Perry, Jr., he opened his eyes as they admired him; that he later closed his eyes, stopped breathing, and went limp as the mother held him the second time; that the grandmother ran, carrying him, to the nurse's station for help; and that it was a nurse who returned him to the LDRP's crib/warming unit where resuscitation occurred, is accepted over the small amount of contrary hearsay contained in Dr. Mohamed's discharge summary quoted infra at Finding of Fact 54. Concerning Perry, Jr.'s, cardiopulmonary event at 2:12 p.m., a nurse recorded in the "Health Care Professionals' Progress Notes," in pertinent part, as follows: 5/7/08 1412: arrived to labor room 302. Observed infant on open warmer apneic and intubation performed per B. Miller with 3.0 ET tube PPV with 100% FI02. See Dr. Maniscalco progress notes. To newborn nursery via warmer with PPB en route with chest compression 2.6 cc epinephrine via ET tube. CPR continues ETC 11.5 cm @ lip HR54 . . . (Ex. C-103). It is also accepted that because of the run out/run in period, the note at 2:12 p.m., may actually show the hypoxic event as occurring a minute or two later than it actually occurred, but such a small delay is immaterial, given the rest of the evidence. Dr. Maniscalco's (surgeon's) progress note at 1455 [2:55 p.m.], reads, in pertinent part: 5/7/08 1455: Called stat to postpartum newborn in full arrest. CPR in progress. Intubated B. Miller . . . No IV access. Epinephrine/Atropin per ETT. HR 80's [to] 122+ palpable pulse. Dr. Azam in. IV established. Fluid bolus given. Pet. Color improved but . . . Dr. Azam to place UVC and assuming patient care. (Ex. C-81). After resuscitating Perry, Jr., at approximately 2:55 p.m., and moving him to the newborn nursery on mechanical ventilation, a chest X-ray was taken. Radiologist Billingsley's report, printed at 1604 [4:04 p.m.], on May 7, 2008, reads: INDICATION: Intubated, decreased breath sounds COMPARISON: None FINDINGS: The endotracheal tube tip is in the left mainstream bronchus. There is complete opacification of the right hemithorax likely due to inefficient aeration of the right lung. In the left lung there is patchy parenchymal opacification which may be due to . . . meconium aspiration in a term infant. (emphasis added). (Ex. C-97; see also Ex. C-99-100). Repeated X-rays thereafter also diagnosed "meconium aspiration syndrome." Arterial blood gas printouts showed severe acidosis as follows: Time pH pCO2 pO2 1520[3:20 p.m.] 6.549 65.4 152.3 1623[4.23 p.m.] 6.894 30.4 133.9 1755[5:55 p.m.] 7.096 32.5 76.5 At 1754 [5:54 p.m.], Perry, Jr., was noted as having tremors of the lips and facial tremors. Ahmed Baker Mohamed, M.D., was notified of the infant's seizure(s) and phenobarbital was administered at 6:12 p.m. At 1813 [6:13 p.m.], Perry, Jr., was air-lifted to Sacred Heart Hospital's Neonatal Intensive Care Unit (NICU). A discharge summary by Dr. Mohamed reads, in pertinent part: REASON FOR TRANSFER: Respiratory failure HISTORY OF PRESENT ILLNESS: This is a newborn, 1 day old, born in Bay Medical Hospital on May 7, 2008, as per report normal vaginal delivery with no reported complications during pregnancy or labor. After one hour from delivery, the baby was in the mother's room who asked for help because the baby stopped breathing and moving. The nurse rushed to the mother's room and found the baby pale, not moving and not breathing. The Ambu bag was started and called anesthesia who intubated the baby. Dr. Azam was called to evaluate the patient. She ordered epinephrine, IV fluid bolus and the patient was put on mechanical ventilation. It was reported that during the suction, meconium came out in a moderate amount. The patient was moved to the nursery on mechanical ventilation. Sacred Heart neonatal intensive care was called and arrangements were made to transport the patient to the neonatal intensive care. Prenatal labs were unremarkable. *** IMPRESSION: A one day newborn with respiratory failure, rule out sepsis, rule out aspiration, rule out pneumonia. (emphasis added). (Ex. C-73). Perry, Jr., stayed at Sacred Heart Hospital in Pensacola from May 7, 2008, to October 1, 2008, and was subsequently seen in other facilities. On July 2, 2008, and September 10, 2008, Perry, Jr., was seen by C. Anthony Hughes, M.D. (pediatric otolaryngologist). Dr. Hughes diagnosed Perry, Jr., as having hepatic encephalopathy, bilateral cortical injury secondary to hypoxic ischemic encephalopathy. On September 24, 2008, Perry, Jr., was seen by Kristin Van Hook, M.D., a pediatric pulmonologist, who diagnosed him at four months of age, with static encephalopathy and seizure disorder secondary to arrest shortly after birth from having suffered a severe anoxic injury at one hour of age. Coverage under the plan and the statutory presumption. Coverage is afforded under the Plan for infants who suffer a "birth-related neurological injury," which for our purposes here, is defined as: . . . injury to the brain . . . of a live infant . . . caused by oxygen deprivation . . . occurring in the course of labor, delivery, or resuscitation in the immediate postdelivery period in a hospital, which renders the infant permanently and substantially mentally and physically impaired." See § 766.302(2), Fla. Stat. Normally, Petitioners, as the proponents of the issue, would have the burden to demonstrate that Perry, Jr., suffered a "birth-related neurological injury." See Balino v. Dep't of Health and Rehab. Servs., 348 So. 2d 349, 350 (Fla. 1st DCA 1977)("[T]he burden of proof, apart from statute, is on the party asserting the affirmative of an issue before an administrative tribunal."); Galen of Fla., Inc. v. Braniff, 696 So. 2d 308, 311 (Fla. 1997)("[T]he assertion of NICA exclusivity is an affirmative defense."); Tabb v. Fla. Birth-Related Neurological Injury Compensation Ass'n, 880 So. 2d 1253, 1260 (Fla. 1st DCA 2004)("As the proponent of the issue, the burden rested on the health care providers to demonstrate, more likely than not, that the notice provisions of the Plan were satisfied."). However, herein, Petitioners have the benefit of a stipulation regarding notice issues and also that the statutory presumption contained in Section 766.309(1)(a) applies in this case. For our purposes here, the presumption reads: If the claimant has demonstrated, to the satisfaction of the administrative law judge, that the infant has sustained a brain . . . injury caused by oxygen deprivation . . . and that the infant was thereby rendered permanently and substantially mentally and physically impaired, a rebuttable presumption shall arise that the injury is a birth-related neurological injury as defined in s. 766.302 (2). The parties have stipulated that, as a matter of law, Petitioners are entitled to a rebuttable presumption that Perry, Jr., suffered a birth-related neurological injury, and it is undisputed herein, that Perry, Jr., suffered an injury to his brain caused by oxygen deprivation which rendered him permanently and substantially mentally and physically impaired and which ultimately resulted in his death. What remains for determination is whether or not the oxygen deprivation and the brain injury together occurred "in the course of labor, delivery, or resuscitation in the immediate postdelivery period." NICA suggests that the statutory presumption has been rebutted, asserting that the evidence demonstrates that the oxygen deprivation and injury to Perry, Jr.'s, brain and his subsequent neurologic impairment did not occur during "labor, delivery, or resuscitation in the immediate postdelivery period in a hospital" (the statutory period), because both the hypoxic insult which created the brain injury and the resultant brain injury itself did not occur until more than an hour after Perry, Jr., had been stabilized in the LDRP. NICA claims that both Perry, Jr.'s, oxygen deprivation and brain injury occurred when Perry, Jr., became apneic and was intubated, with chest compressions, and administration of epinephrine at 2:12 p.m. The likely timing of Perry, Jr.'s, brain injury. The statutory period is not defined under the Plan. Similarly, the medical experts herein acknowledged that this period is not defined within the medical community, but they agreed that this period would last until the infant was stabilized. Dr. Willis testified that although the term "resuscitation in the immediate post-delivery period" is not defined under the NICA Plan, the statute, or within the medical community, it was his opinion that it should be defined as follows: [W]hen the baby's born, once the baby is stabilized and no longer requires medical attention, care to maintain adequate oxygenation, to maintain adequate blood pressure, when the baby is surviving on its own without intervention, then, as far as I'm concerned, the immediate resuscitative period is over. (Ex. N-779). Dr. Lopez's definition was not very different. He testified: I would imagine the immediate postdelivery period would be what some doctors and many (TR-129). organizations call the fourth stage of labor, which is the period of time after the complete delivery of the baby until the baby has been stabilized and is no longer under observation. Orlando Regional Health Care System, Inc. v. Florida Birth-Related Neurological Injury Plan, 997 So. 2d 426 (Fla. 5th DCA 2008), instructs that the determination of what is "immediate" is a factual determination upon which medical testimony should guide the Administrative Law Judge. The medical experts, Dr. Willis and Dr. Lopez, are agreed that meconium only becomes an issue once the membranes are ruptured (during labor and delivery); the progress of meconium aspiration syndrome, if it occurs, is that the meconium is inhaled into the baby's lungs, creating an inability to take in enough oxygen to permit normal brain function, and eventually not enough oxygen is let in to sustain life. Dr. Lopez credibly testified that the alveoli of the lungs swell, cutting off the oxygen and causing cardiac arrest and oxygen deprivation. Dr. Willis is a Florida-licensed, board-certified obstetrician-gynecologist and a maternal-fetal medicine specialist. In this capacity, he focuses on providing consultative care to women with high risk pregnancies. He has not delivered a baby within the last ten years. Because meconium becomes an issue only after a patient's membranes are ruptured and the meconium becomes evident, Dr. Willis has not personally dealt with a meconium aspiration event in at least 10 years, and he was unable to give an opinion within reasonable medical probability as to whether meconium aspiration syndrome caused Perry, Jr.'s, hypoxic event and brain injury. However, he did opine that Perry, Jr.'s, brain injury did not occur within the statutory period so as to make it compensable under the NICA Plan. Dr. Berto Lopez has been a Florida-licensed, board- certified obstetrician for 23 years. He currently has privileges at four hospitals, delivers 30 babies per month, and is part of a high-risk perinatal transfer team at St. Mary's Hospital, Palm Beach, Florida. As such, it is found that Dr. Lopez was more qualified than Dr. Willis to address the issues of this particular case. Dr. Lopez faulted Dr. Jackson's records and failure to "evaluate" the child and further faulted the hospital's failure to monitor the child. He opined summarily that Perry, Jr.'s, loss of oxygen was an undiagnosed continuing insult that began at birth with aspiration of a moderate amount of thick meconium, and with loss of oxygen continuing through incomplete immediate resuscitative efforts in the LDRP, and that the remaining meconium, some of which was pumped out when Perry, Jr., was resuscitated at 2:12 p.m., had created a sequela of events, including loss of oxygen, brain damage, and full cardiopulmonary arrest at that time, approximately an hour after birth. Therefore, he concluded that the postdelivery resuscitative period extended through the 2:12 p.m., episode. However, upon closer questioning relevant to the issue of whether Perry, Jr.'s, oxygen deprivation and/or brain injury occurred within the statutory period of "labor, delivery, or resuscitation in the immediate postdelivery period in a hospital," Dr. Lopez testified as follows: [Questions by Mr. Bajalia] Q: And based on your review of the fetal monitor strips, you agree that there was no hypoxic insult or injury to Perry Russell, Jr.'s brain during labor? A: That's correct. (TR-145). *** Q: . . . Regardless of what you think of what Dr. Jackson did or didn't do, his assessment and his determination was that the baby was in good and stable condition; you agree with that? A: That's correct. (TR-148). *** Q: So it's your testimony that he [Perry, Jr.] was never in good and stable condition at any point in time? A: I'm not saying that he wasn't stable for a period of time. Q: There was a point in time, you're testifying here today, that he was in fact stabilized? A: He was stable, yes. (TR-149). *** Q: The one-minute Apgar score is inconsistent with a baby who has suffered an injury to the brain at that particular point in time? A: That's correct. Q: That one-minute Apgar score is not indicative of hypoxia or brain injury? A: Correct. Q: Now Perry's five-minute score was recorded as what? A: Nine. Q: And is that normal? A: Yes. But, it's normal, but the resuscitation not only included bulb and suction catheter. That also under oxygen, this baby has a nine when it's given 80 percent oxygen by -- with something called blow-by. Blow-by is an open tube of oxygen that's usually attached to a wall oxygen dispenser. . . . *** Q Is the fact that Perry Russell as part of the initial resuscitative efforts received blow-by oxygen, is that in and of itself indicative of him sustaining a brain injury at that particular point in time? A: No. Q: Now back to the Apgar score. You testified his Apgar score at five minutes was nine? A: Yes. Q: And that's normal? A: Yes. Q: And Perry's five minute Apgar score is, in your opinion, inconsistent with hypoxic [sic]? A: Correct. Q: It's inconsistent with him having suffered an injury to the brain at that particular point in time? A: Correct. Q: Now, I'm going to show you what's been marked and identified as Joint Exhibit C, and it's part of the records you have in front of you, page 107 of the stipulated record. Are you familiar with that document? A: Yes. Q: What is it? A: It is the nurse evaluation form for part of the postpartum period. Q: And in fact it's titled possible problems typical of age/weight categories? A: That's what it's labeled, yes. Q: And this appears to be an assessment of Perry's condition by the nurses charged with his care with respect to possible problems he may be experiencing; do you agree with that? A: Yes. Q: And one of these problems that is identified on this record is asphyxia and/or meconium aspiration? A: Correct. Q: Okay. So those are the things that they're specifically looking for in an effort to determine whether or not Perry Russell, at these particular points in time, was experiencing asphyxia, oxygen deprivation, or meconium aspiration, or meconium aspiration syndrome; you would agree with that? A: Yes. (TR-150-153). *** Q: Okay. And so despite the fact that Perry received some initial resuscitative efforts, which you described as suctioning and some blow-by oxygen, at 13:00, ten minutes after birth, based on what we've been through thus far, he seems to be looking pretty good? A: Yes. (TR-155). *** Q: Okay. Based on this assessment, at ten minutes after birth you described I think Perry Russell in your deposition as a rock star; do you remember that? A: Yeah, he's a rock star, looks good. Q: Appears to be stabilized? A: Yeah. Q: On this assessment Perry didn't appear to be experiencing or suffering from asphyxia from meconium aspiration; you agree with that? A: Correct. Q: And he doesn't appear to have any difficulty breathing? A: Correct. Q: He's apparently breathing on his own? A: Correct. Q: He is not in respiratory failure? A: Correct. Q: Okay. This assessment is inconsistent with hypoxia at that particular point in time? A: That's -- if we accept this as accurate, this photograph says at this moment things are looking great. (TR-155-156). *** Q: Based on what's documented here, Perry apparently had no injury to his brain at this particular point in time? A: Correct. Q: At 13:00, based on what's documented there, Perry Russell is in good and stable condition? A: Yes. Q: He didn't appear to have any life- threatening condition at that point in time? A: Correct. Q: He appeared -- it appeared that he had made a safe transition from utero life to life outside the uterus? A: Yes. Q: Based on what's documented at 13:00, there were no active resuscitative measures being administered to Perry Russell? A: Correct. (TR-157). *** Q: Now let's talk about the assessment that was done at 13:15. Perry was born at 12:50. At 13:15, that's 25 minutes postdelivery? A: Correct. (TR-158). *** Q: At 25 minutes of life Perry Russell doesn't appear to be having any difficulty breathing? A: Correct. Q: At 25 minutes of life he's breathing on his own? A: Correct. Q: At 25 minutes of life he doesn't appear to be in respiratory distress? A: Correct. Q: At 25 minutes of life, based on what's documented there, this assessment would be inconsistent with a baby who has experienced hypoxia? A: Correct. Q: It would be inconsistent with a baby that's acidotic? A: Correct. Q: It would be inconsistent with a baby suffering from asphyxia? A: Correct. Q: It's inconsistent with a baby that has sustained an injury to the brain? A: Correct. Q: At 13:15, 25 minutes after he was born, it would appear that Perry was in good and stable condition? A: Yes. Q: It would appear that he had no life- threatening conditions? A: Correct. Q: It would appear that there were no active resuscitative measures being administered to Perry Russell at that time? A: Correct. Q: And it would appear none were needed? A: Correct. (TR-160-161). *** Q: Okay. And you told me at the beginning of this -- of my examination that just because a baby is experiencing an ongoing spectrum of oxygen deprivation, that doesn't mean that he has sustained an injury to the brain? A: Not - at certain points in time. It's a spectrum that may start as okay and then go - progress to hypoxia and brain damage. Q: Exactly, but the mere fact - my point is, the mere fact that Perry may have been experiencing a spectrum of oxygen deprivation, it doesn't mean he has a brain injury at 13:00? A: Correct. Q: It doesn't mean he had a brain injury at 13:15? A: That's right. Q: In fact, based on what's documented in the records and what we know with respect to what occurred at 14:12 an hour and 20 minutes after birth, that is when he probably and most likely incurred an injury to the brain? A: No. *** A: It was my opinion it occurred before that. Q: Before 14:12 [2:12 p.m.]? A: Right. Q: Okay. But you have no idea when? A: I could not pinpoint it to the exact minute or time. What we see at 14:12 [2:12 p.m.] is in fact that the baby is in full cardiopulmonary arrest, requiring extensive resuscitation. (TR-162-163). *** Q: All right. And regardless of whether you think the nurses could have, should have done more with respect to their assessments of Perry Russell at 13:00 and 13:15 [1:00 p.m. and 1:15 p.m.], it is, in your opinion, what they documented at 13:00 and 13:15 you would agree would indicate he was not in respiratory distress? A: Yes. Q: Was not having any problems breathing? A: That's right. Q: And that he had not suffered an injury to his brain at that particular point in time? A: Correct. (TR-165). Overall, it is most probable that the oxygen deprivation that caused Perry, Jr.'s, brain injury did not happen until the code was called at 2:12 p.m., well beyond the time he was stabilized in the LDRP. Given the proof, it is resolved that, more likely than not, Perry, Jr., did not suffer brain injury due to oxygen deprivation that occurred during labor, delivery, or resuscitation immediately following delivery. Rather, it is more likely than not that Perry, Jr., suffered hypoxic ischemic brain damage sometime after the statutory period had ended, that is, after the obstetrician and nurses left him in stable condition in the LDRP. It is most likely that the damage was done when he became apneic and had to be resuscitated about an hour later. (See Findings of Fact 31 and 38). Alternatively, it is conceivable, but not proven, that Perry, Jr., suffered oxygen deprivation from some unspecified point after being stabilized at 1:15 p.m., and the oxygen deprivation continued undetected until he went into cardiac arrest at 2:12 p.m., but either way, he did not suffer brain damage during the statutory period.
The Issue At issue is whether Elizabeth Ann Adams, a minor, qualifies for coverage under the Florida Birth-Related Neurological Injury Compensation Plan (Plan).
Findings Of Fact April D. Adams and Jeffrey Floyd Adams are the natural parents of Elizabeth Ann Adams, a minor. Elizabeth was born a live infant on September 17, 2004, at St. Luke's Hospital, a licensed hospital located in Jacksonville, Florida, and her birth weight exceeded 2,500 grams. Obstetrical services were delivered at Elizabeth's birth by Michelle McLanahan, 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. Sufficient notice of participation in the Florida Birth-Related Neurological Injury Compensation Plan on the part of Michelle McLanahan, M.D., and St. Luke's Hospital was provided to April D. Adams. Coverage under the Plan Pertinent to this case, coverage is afforded by the Plan for infants who suffer a "birth-related neurological injury," defined as an "injury to the brain . . . caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate postdelivery period in a hospital, which renders the infant permanently and substantially mentally and physically impaired."3 § 766.302(2), Fla. Stat. See also §§ 766.309 and 766.31, Fla. Stat. Here, Petitioners were of the view that Elizabeth suffered a subgaleal hemorrhage4 (a bleed) and resulting subgaleal hematoma5 (a collection of blood within the tissue) between the skull and scalp (outside the brain) resulting from the use of the vacuum extractor during delivery, and that the hemorrhage was substantial enough to result in hypovolemia, and ultimately hypoxic-ischemic brain injury.6 (Petitioners' Memorandum Regarding Final Order, pp. 5-7). In contrast, NICA was of the view that the record failed to support the conclusion that Elizabeth's brain injury was caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate postdelivery period and that, regardless of the etiology of her brain injury, Elizabeth was not permanently and substantially mentally and physically impaired. Intervenor expressed no position on the issue. Elizabeth's birth and immediate newborn course At or about 11:24 a.m., September 16, 2004, Mrs. Adams, with an estimated delivery date of September 20, 2004, the fetus at 39 3/7 weeks' gestation, and a history of mild pregnancy induced hypertension (PIH), was admitted to St. Luke's Hospital for induction of labor. There, initial physical examination revealed her membranes were intact, no vaginal bleeding, and external fetal monitoring revealed a reassuring fetal heart rate baseline of 150-160 beats per minute, average long term variability and no decelerations. At or about 12:40 p.m., an IV was started for hydration, and at 3:14 p.m., Mrs. Adams' membranes spontaneous ruptured, with clear fluid noted. At the time, vaginal examination revealed the cervix at 2 centimeters dilation, effacement at 70 percent, and the fetus at -3 station. In the interim, external fetal monitoring was reassuring for fetal well-being. Thereafter, Cytotec ("miso[prostol]") was placed vaginally to soften the cervix (for induction of labor). Mrs. Adams' progress continued to be monitored, and at 6:10 p.m., vaginal examination revealed the cervix unchanged. However, at 6:58 p.m., vaginal examination revealed some change, with the cervix at 3-4 centimeters, effacement at 70 percent, and the fetus at -3 station, and an intrauterine pressure catheter (IUPC) was placed to measure the force of contractions during labor. Fetal monitoring continued to be reassuring for fetal well-being, with a fetal heart rate baseline of 145-160 beats per minute, average long term variability, and no decelerations. At 8:16 p.m., Pitocin infusion (for labor induction) was started, and at 8:37 p.m., contractions were noted at 1-2 minutes, and vaginal examination revealed the cervix at 5 centimeters dilation, effacement at 70 percent, and the fetus at -1 station. Fetal monitoring continued to be reassuring, with a baseline in the 150s. Mrs. Adams' progress continued, albeit slowly, with a prolonged second stage of labor (the expulsion/pushing stage) lasting more than two and a half hours,7 and at 5:03 a.m., September 17, 2004, Elizabeth was delivered vaginally, with vacuum assistance (three attempts). Of note, approximately three hours before delivery, recurrent variable decelerations and a mild baseline tachycardia developed, and approximately eight minutes before delivery severe, repetitive variable decelerations developed which prompted the vacuum-assisted delivery. At delivery, Elizabeth was dried, stimulated, and bulb-suctioned, otherwise no resuscitation measures were required. Apgar scores were good (8 and 9, at one and five minutes).8 Physical examination at 5:10 a.m., revealed no abnormalities, with the exception of an elevated temperature (102.7, rectal) and skin color (acrocyanosis was noted).9 By 5:40 a.m., skin color was noted as pink. Elizabeth roomed-in at her mother's bedside, and was routinely monitored by hospital staff. Of note, Elizabeth's temperature remained elevated until 1:30 p.m., when it was documented at 98.1 (auxiliary). In the interim, at 11:58 a.m., with temperatures of 100.0 (auxiliary) and 100.7 (rectal), complete blood count (CBC) and blood cultures were drawn. The CBC results revealed an elevated white blood count. Under the circumstances, the attending physician (Dr. Schwartz) noted, at 4:34 p.m., "[w]ill repeat CBC in a.m. . . . [w]ill not st[art] ABX unless temps elevated again." Blood culture was subsequently reported as negative. It also may be noted, although not shown to be clinically significant, that Elizabeth's behavior was, starting at 6:10 a.m., periodically described as "irritable" and "fussy." (Exhibit 18, pp. 22-24). Otherwise, Elizabeth's newborn stay was without incident, with normal newborn examinations, breastfeeding well, and voiding and stooling appropriately, until 8:35 p.m., when the attending nurse made the following entry in the records: Assumed care of infant. Infant/Mom ID # checked/verified. Physical assessment done and noted. Infant noted to be jittery and irritable. Mom states that infant has not breastfed since 1700-1730. Temp stable now at 98.8. Infant noted to settle after wrapping. Placed in mother's arms. Mom will breastfeed infant shortly. Will eval infant's next feeding. Thereafter, at 8:42 p.m., the attending nurse made the following entry: Called into room by parents. States that infant shreiked then arched her back and turned purple. Upon enter room infant's color noted to be dusky with purple lips. Left eye noted to be turned in and rt eye gazed. Unwrapped and body noted to be modled but no shaking present at this time. Infant taken to nicu for immediate evaluation. Elizabeth's subsequent care was summarized in her Discharge Summary, as follows: . . . Nursing brought the infant to this Special Care Nursery and it was felt that the infant was having seizure activity. At this point a complete septic workup was performed. The infant was placed on IV antibiotics and further cultures including spinal fluid were sent. The workup was initially benign; however, a CT scan [on September 18, 2004] was within normal limits except that J. Norman Patton, M.D., Division of Cardiovascular Diseases, Internal Medicine, could not completely rule out some mild evidence of inflammatory response in the brain . . . . The CT scan of September 18, 2004, was done to rule out a bleed as the cause of Elizabeth's seizures, and was read as follows: CT head without and with contrast. Iodinated contrast was given per protocol. Nonionic contrast was utilized. Small subgaleal hematoma in the biparietal locations. The intracranial contents appear unremarkable. Specifically, there is no evidence for parenchymal/extra-axial hemorrhage, nor pathologic enhancement. The ventricle volume is within normal limits, and without midline shift. A subgaleal hematoma or hemorrhage is a bleeding between the skull and the skin on the outside of the skull (scalp), and not within the brain. (Exhibit 18, pp. 15, 16, and 18). The Discharge Summary continued, and documented Elizabeth's care as follows: At this point acyclovir was also added to the antibiotic regimen. The CSF PCR was negative, but surface cultures revealed positive HSV [herpes simplex virus] in the rectal swab, although negative in the oropharynx. For this reason the infant was continued on acyclovir for a total of 21 days. After negative cultures the ampicillin and gentamicin were discontinued. The infant also required mild oxygen in this period and was placed on 1.5 liters 30-40%. Over the next several days this was able to be discontinued. Dr. Gamma, Pediatric Neurology, was involved in the patient's case and consulted on a regular basis. EEG was consistent with seizure activity. The infant was on phenobarbital and later secondary to continued occasional seizures, was started on Cerebyx. The goal was to get this infant's phenobarbital level to between 20 and 30; however, the infant metabolized the phenobarbital very well and despite increasing the dose, the phenobarbital level remained in the 19-20 range. Eventually the Cerebyx was discontinued and the infant is discharged home only on phenobarbital. The infant initially was fed fairly slowly, but by the end of admission was eating well and gaining weight steadily. The infant was ready for discharge on 10/09/04 following 21 days of acyclovir and at this point the infant had a phenobarbital level of 19.3 and a weight of 3940 grams or 8 pounds 11 ounces. The parents have been very involved with the infant, visited often, and have demonstrated good care for this baby. The infant's workup also includes urine for amino acids, which was within normal limits. Liver function tests were within normal limits. Screening CBCs were within normal limits. Ammonia was normal at 36. Urine organic acids were within normal limits . . . . An MRI performed on September 22, 2004, revealed: . . . restricted diffusion in the left occipital lobe, both parietal and frontal lobes, worse on the left, consistent with cytotoxic edema as seen in infarction, secondary to ischemic and or sequelae of severe meningoencephalitis The ventricle volume is within normal limits, and without midline shift. A head ultrasound performed on September 30, 2004, was normal and reported, as follows: Using the anterior fontanelle as an acoustic window, routine coronal and sagittal images were obtained. No evidence for intracranial or germinal matrix hemorrhage. Ventricles are not dilated and appear normal in shape and position. No obvious parenchymal abnormality. Elizabeth was discharged on October 9, 2004. Physical examination on discharge was noted in her Discharge Summary, as follows: Physical exam on discharge revealed a discharge weight of 3940 grams, length of 53 cm, and head circumference of 35.5 cm. The infant was well-developed, well- nourished, alert, pink non-jaundiced female in no acute distress. HEENT was negative. Anterior fontanelle was soft and flat. Lungs were clear to auscultation in no distress. Heart - Regular rhythm without murmur. Abdomen - Soft, benign and nontender. GU - Normal female. Back - Normal extremities, negative Ortolani, negative bilaterally. Neurologic exam intact. Discharge medication was phenobarbital. Follow-up was recommended with pediatrics, neurology, Early Intervention Program at Shands, and Occupational Therapy and Physical Therapy at Nemours. Discharge Diagnoses were: HSV ENCEPHALITIS - SEPSIS. NEONATAL SEIZURES. TERM FEMALE NEWBORN. Of note, subsequent testing revealed that Elizabeth had not been exposed to the herpes simplex virus (HSV), and the positive HSV result was a false positive. Elizabeth's subsequent development Following Elizabeth's discharge from St. Luke's, she was evaluated by the Early Intervention Program (in October 2004) to resolve whether she qualified for services. At the time, it was felt Elizabeth did not qualify for the program, as her development was within normal limits (WNL) for her age. However, in March 2005, at age 6 months, Elizabeth was reevaluated and found eligible for occupational, speech, and physical therapy services due to motor and language delay. Those services were discontinued by October 2005, since Elizabeth's developmental growth appeared age appropriate. (Exhibit 7). Elizabeth was weaned off phenobarbital at age 15 months (about December 2005) and remained seizure-free until October 13, 2006, when a seizure was noted and she was ultimately transported (after treatment in a local emergency room) to Wolfson's Childrens Hospital (Wolfson's) in Jacksonville. There she was loaded with phenobarbital and Dilantin, the seizures stopped, and on October 15, 2006, she was discharged on maintenance dosage of phenobarbital. However, on October 16th, she had a second seizure and was readmitted to Wolfson's, and then on October 18, 2006, discharged on an increased dosage of phenobarbital. Thereafter, in December 2006, her medication was changed from phenobarbital to Trileptal. (Exhibit 9). Since that time, Elizabeth has experienced seizures on four occasions, three of which she was treated at Wolfson's (April 17-19, 2007; March 19-20, 2008; and July 10, 2008) and the last of which (March 1, 2009) she apparently was treated at home in North Carolina. (Exhibits 9 and 27). Apart from her seizure disorder, Elizabeth's health has been good, and developmentally she continued to make good progress, without the need for any therapies since they were discontinued in October 2005. Currently, Elizabeth attends a regular school program, and was shown to evidence very mild physical impairment and no mental impairment. (See, e.g., Exhibits 16, 17, and 19). Whether Elizabeth suffered a "birth-related Neurological injury" To address whether Elizabeth suffered a "birth-related neurological injury," the parties offered a Stipulated Record (Exhibits 1-28), that included the medical records associated with Mrs. Adam's antepartal course, the medical records associated with Elizabeth's birth and subsequent development, the deposition testimony of the delivering obstetrician (Dr. McLanahan), and the deposition testimony of Mr. and Mrs. Adams. The parties also offered the deposition testimony of Donald Willis, M.D., a physician board-certified in obstetrics and gynecology, and maternal-fetal medicine, and Michael Duchowny, M.D., a physician board-certified in pediatrics, neurology with special competence in child neurology, electroencephalography, and neurophysiology. Based on his evaluation of the medical records, it was Dr. Willis' opinion that Elizabeth did not suffer a brain injury caused by oxygen deprivation or mechanical injury during labor, delivery, or resuscitation in the immediate postdelivery period.10 In so concluding, Dr. Willis observed Elizabeth was not depressed at birth; her Agpar scores were normal (8 at one minute, and 9 at five minutes); she did not require any significant resuscitation (only stimulation and bulb- suctioning); and her newborn course was without incident until seizures were noted at 16 hours after birth. As for the subgaleal hemorrhage (the bleed between the skull and the scalp) Elizabeth was shown to have suffered (on the CT scan of September 18, 2004), Dr. Willis agreed it was likely related to the vacuum-assisted delivery. As for the cause of the periventricular hemorrhage (brain injury/stroke) Elizabeth was shown to have suffered (on the MRI of September 22, 2004), Dr. Willis voiced no opinion, and deferred to the expertise of a pediatric neurologist. As for Petitioners' theory of the case, that a subgaleal hemorrhage can progress to cause bleeding within the brain as a result of hypovolemia, Dr. Willis agreed. However, he did not see evidence in this case to suggest such a causative connection. Dr. Willis expressed his opinion, as follows: Q. Tell me why you don't think, if you don't think, that her brain injury is related to the vacuum extraction? A. Well, subgaleal hemorrhage is between the skull and the skin on the outside of the skull, and that's very common with vacuum extractions. But the only way that that can cause a brain injury that I'm aware of is that if so much hemorrhage occurs into that hematoma that the baby becomes hypovolemic and has a stroke due to hypovolemia and low blood pressure related to blood loss. I am not aware that this child had a subgaleal hematoma that was to that extent. (Exhibit 18, pp. 17 and 18). See also Exhibit 18, p. 35. Dr. Duchowny evaluated Elizabeth on September 10, 2008. Based on his evaluation, as well as his review of the medical records, Dr. Duchowny was of the opinion that Elizabeth's impairments were likely the result of a meningoencephalitis (an "inflammation of the brain and meninges"11), resulting from a viral infection, albeit not HSV, as opposed to a brain injury caused by oxygen deprivation or mechanical injury occurring during labor or delivery. Dr. Duchowny was also of the opinion that Elizabeth was neither substantially mentally nor substantially physically impaired. (Exhibits 15 and 19). Dr. Duchowny described the results of his evaluation, and the bases for his opinions, as follows: Q. . . . During that examination did you obtain any medical history from Elizabeth's family? A. Yes. Q. What was the history that you obtained? A. I was able to speak to Elizabeth's mother, who was the person, the caretaker, bringing Elizabeth to my office; and she first talked about Elizabeth's seizures, which began shortly after birth, at age sixteen hours; and continued with a total of five seizures during her life. The seizures, although infrequent, were prolonged, and her mother indicated that they lasted between three and five hours, all of which, obviously, resulted in hospitalizations. They were terminated with rescue Diastat in order to stop the status epilepticus. All of Elizabeth's seizures began on the right side of her body but then would generalize to involve both arms and both legs, and most recently Elizabeth has been treated which Trileptal, which apparently has brought the seizures under control. Her mother then went on to describe mild weakness on the right side of Elizabeth's body. She commented that Elizabeth had trouble with fine motor coordination, particularly a pincer grasp, and as a result was a left hander. However, Elizabeth's overall motoric ability was good. She didn't have any specific limitations to her motor abilities, and she was fully functional for her age, which at that time was three years. On a positive note, her mother indicated that her mental development was going well, that there were no delays in her acquisition of speech and language, and that she was in the New Dimensions Preschool Program where she was attending a regular classroom. There has never been any regression of Elizabeth's abilities, and at the time that I evaluated Elizabeth in September, she did not have an ongoing need for either physical or occupational therapy. Otherwise, things were good; she was healthy. She was under the care of Dr. Harry Abrams at Nemours Children's Hospital. She continued to have abnormal EEGs, and her mother commented that her MRI scan of the brain revealed damage, primarily on the left side of her brain. Q. What information, if any, did you obtain regarding her birth? A. Well, again, this was information from Elizabeth's mother, and she told me that Elizabeth was born after a term gestation at St. Luke's Hospital. It was a natural delivery, but with the assistance of a vacuum for the extraction. Elizabeth weighed seven pounds, eleven ounces. She breathed well. She was not a jaundice baby, but that she remained in the NICU at St. Luke's Hospital for a treatment of suspected infection with the herpes simplex virus; so essentially, a herpes simplex encephalitis concern. Q. Thank you. Did you obtain any information with respect to Elizabeth's growth and development? A. Yes. Elizabeth rolled over and sat at six months and then was able to stand at age ten months. She was walking on her own by age thirteen months and began talking in single words between a year and age eighteen months. At the time I saw her she had not yet been toilet trained, but she received all of her immunizations and had no known allergies to medications. She had undergone surgery on two occasions for the ear tubes and, of course, there were the multiple hospitalizations for the recurrent bouts of status epilepticus. Q. Did you perform a physical examination of Elizabeth? A. Yes. Q. What were your findings upon that examination? A. When I saw her, she was actually quite cooperative so, socially, she was very appropriate for her age. She seemed appropriately nourished and developed. Her weight was recorded at thirty-five pounds. There was no abnormalities of her skin, neck and she had no abnormal aspects of her body which suggested a malformation. I noted that her spine was normal. Her head growth was good. She had a head circumference of 49.1 centimeters, which for age three years is within standard percentiles. There were no abnormalities of her heart, her lungs, her abdomen, and her extremities or her peripheral pulses. Q. Did you also perform a neurological examination of Elizabeth? A. Yes. And once again, in terms of her social abilities, she actually was quite good for her age and she was appropriately verbal at her age level. She answered questions, she provided decent verbal content. I thought her speech sounds had a very mild disarticulation, but she knew her colors. She was able to identify parts of her body, and she was able to draw with a pencil using her left hand. No drooling was noted. Examination of her cranial nerves was essentially normal, and her motor examination revealed a well developed, age appropriate amount of muscle strength, bulk of her muscle and muscle tone. I was unable to detect any specific focal weakness, although, again, there was a difference in terms of her fine motor coordination. Even though she used both hands cooperatively, she clearly preferred her left hand, although I was able to demonstrate a pincer grasp bilaterally and reasonably good manual dexterity. Where I did think there was asymmetry had to do with her walking where her left arm would swing in a more prominent fashion on the left compared to the right. Also, there was a tendency actually for both feet to turn in, but this was more prominent, again, on the right side. I thought that Elizabeth's sensory examination was normal and that her gait was appropriate in terms of coordination, despite the asymmetric arm swing. Her deep tendon reflexes were normal and symmetric on both sides of the body, in other words, both arms and legs; and her plantar response, which is a reflex response to stroking the bottom of the feet, was normal. There were no abnormalities of her neurovascular examination, meaning that there were no asymmetries when a stethoscope was placed on her neck, head or over her eyes. The bones of her skull were closed, which was appropriate. Q. Okay. Thank you. Based upon your review of the medical records and documents which you identified earlier, and based upon your examination of Elizabeth and the findings from that examination, were you able to form an opinion as to the nature and extent of Elizabeth's neurological delays or developmental delays, if any, and the etiology of those delays? A. Well, there were some findings on the neurological exam with respect to Elizabeth's motor coordination, and my impression was that these findings were, at best, mild. I would characterize them really as very mild. Q. Specifically, what are those findings? A. The asymmetric arm swing, the establishment of handedness on the left and slightly decreased -- well, really, minimal, minimal change in dexterity. Really, the arm swing and the handedness. Q. And those delays that you've identified and, as I understand it, it's your opinion that you would characterize those as mild? A. Yes. Q. What functional impact, if any, do those mild delays have on Elizabeth based upon your examination of her when you saw her? A. Well, at present I would have predicted that there would be no compromise to her functionality, and that appeared to be the case. Q. With respect to her cognitive development, what were you able to conclude based upon your review of the medical records and your examination of her? A. My examination revealed normal cognitive development; in other words, a level of mental function, which was at age level. So I was, again, not surprised that she was in a regular class at the New Dimensions Preschool. Based upon your review of the medical records, were you able to form an opinion as to the etiology of any of those neurological problems that were identified? A. Well, from a review of the records, I think that there was a strong indication that Elizabeth had had some kind of meningoencephalitis in the first week of life, and I believe that her findings on neurological examination today are related to the previous bout of meningoencephalitis. Q. Do you have an opinion as to whether or not Elizabeth suffers from a substantial mental impairment? A. I do, and that is that I do not believe that Elizabeth has a substantial mental impairment. Q. Do you have an opinion as to whether or not Elizabeth suffers from a substantial physical impairment? A. I do not believe that Elizabeth has a substantial physical impairment either. * * * Q. . . . You mentioned the motor findings that you described as, at best, mild, or very mild, and you listed the asymmetrical arm swing, and the handedness on the left and the minimal loss of dexterity. I think your findings also included abnormalities in the gait, is that correct? A. Yes, that's true. There was a toe-in position bilaterally, but I didn't see that as a functional problem. She did that, but it didn't seem to contribute to any disability at all . . . . (Exhibit 19, pp. 7-16). When, as here, the medical condition is not readily observable, issues of causation are essentially medical questions, requiring expert medical evidence. See, e.g., Vero Beach Care Center v. Ricks, 476 So. 2d 262, 264 (Fla. 1st DCA 1985)("[L]ay testimony is legally insufficient to support a finding of causation where the medical condition involved is not readily observable."); Ackley v. General Parcel Service, 646 So. 2d 242, 245 (Fla. 1st DCA 1994)("The determination of the cause of a non-observable medical condition, such as a psychiatric illness, is essentially a medical question."); Wausau Insurance Company v. Tillman, 765 So. 2d 123, 124 (Fla. 1st DCA 2000)("Because the medical conditions which the claimant alleged had resulted from the workplace incident were not readily observable, he was obligated to present expert medical evidence establishing that causal connection."). Here, the opinions of Doctors Willis and Duchowny were logical, consistent with the record, not controverted, and not shown to lack credibility. Consequently, it must be resolved that the cause of Elizabeth's impairments was most likely a meningoencephalitis, as opposed to a "birth-related neurological injury," and, regardless of the etiology of her impairments, she is not permanently and substantially mentally and physically impaired. See Thomas v. Salvation Army, 562 So. 2d 746, 749 (Fla. 1st DCA 1990)("In evaluating medical evidence, a judge of compensation claims may not reject uncontroverted medical testimony without a reasonable explanation.").
Findings Of Fact Daisy Posada was born on December 1, 2014, at Tampa General Hospital in Tampa, Florida. Donald Willis, M.D., an obstetrician specializing in maternal-fetal medicine, was requested by NICA to review the medical records of Daisy Posada and to opine whether an injury occurred in the course of labor, delivery or resuscitation in the immediate post-delivery period at Tampa General due to oxygen deprivation or mechanical injury. In a report dated December 29, 2017, Dr. Willis described his findings in pertinent part as follows: In summary, delivery was complicated by a significant shoulder dystocia, requiring multiple maneuvers to complete the delivery. The newborn was depressed with Apgar of 0/0. Full resuscitation was required. The newborn hospital course was complicated by multi- system organ failures. The initial ABG, which was done after resuscitation, had a pH of only 692. EEG was abnormal, but MRI was reported as normal. * * * There was an obstetrical event (shoulder dystocia) that resulted in loss of oxygen to the baby’s brain during delivery and continuing into the immediate post delivery period. The oxygen deprivation resulted in at least some degree of brain injury initially, based on the abnormal EEG. However, the brain MRI was normal. There was no mechanical trauma or injury to the spinal cord. Attached to Respondent’s Motion for Summary Final Order is the affidavit of Dr. Willis, dated April 2, 2018. In his affidavit, Dr. Willis affirms the findings in his above-quoted report and maintains that his opinions are within a reasonable degree of medical probability. NICA also retained Michael S. Duchowny, M.D., a pediatric neurologist, to review Daisy Posada’s medical records and to conduct an Independent Medical Evaluation of her and to opine as to whether she suffers from a permanent and substantial mental and physical impairment as a result of a birth-related neurological injury. Dr. Duchowny reviewed the medical records, obtained historical information from Ms. Arellano Benitez, and performed an evaluation on January 31, 2018. In a report authored after the neurological evaluation, Dr. Duchowny summarized his findings, in pertinent part, as follows: In SUMMMARY, Daisy’s neurological examination today reveals no specific findings apart from very slight decreased supination of the left hand. She does not otherwise display left upper extremity weakness and has full range of motion. The examination reveals no functional compromise of the left upper extremity, and the remainder of the neurological examination is unremarkable. * * * Despite a complicated perinatal course, Daisy has developed well-therapeutic hyperthermia may have contributed to her favorable outcome responsible [sic]. As there is no evidence of a substantial mental or motor impairment, I do not believe that Daisy should be considered for inclusion within the NICA program. Respondent’s Motion for Summary Final Order also relies upon the attached affidavit from Dr. Duchowny, dated March 27, 2018. In his affidavit, he affirms the findings contained in his report and opines, based upon his education, training and experience, within a reasonable degree of medical probability, that Daisy Posada has not suffered a substantial mental or physical impairment. A review of the file reveals that no contrary evidence was presented to dispute the findings and opinions of Dr. Willis and Dr. Duchowny. Their opinions are credited.
The Issue At issue in this proceeding is whether Halle Cohen Martinez, III, a minor, qualifies for coverage under the Florida Birth- Related Neurological Injury Compensation Plan.
Findings Of Fact Petitioners, Barbara Mary Martinez and Halle Martinez, Jr., are the natural parents and guardians of Halle Cohen Martinez, III, a minor. Halle was born a live infant on November 12, 2001, at Leesburg Regional Medical Center, a hospital located in Leesburg, Florida, and his birth weight exceeded 2,500 grams. The physician providing obstetrical services at Halle's birth was Wendell Courtney, 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 by the Plan for infants who suffer a "birth-related neurological injury" defined as 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 postdelivery period in a hospital, which renders the infant permanently and substantially mentally and physically impaired." § 766.302(2), Fla. Stat. See also, §§ 766.309 and 766.31, Fla. Stat. To address the cause, timing, and significance of Halle's impairment, Petitioners offered selected medical records relating to Halle's birth and subsequent development, as well as the testimony of Mr. and Mrs. Martinez. In turn, Respondent offered the affidavits and the reports of Doctors Donald C. Willis and Paul R. Carney. The cause and significance of Halle's neurologic impairment At birth, Halle suffered a left brachial plexus injury, with resultant left arm brachial plexus palsy, and a left posterior dislocated shoulder, secondary to the birth brachial plexus palsy. Thereafter, at age 5 months, Halle underwent corrective surgery of the brachial plexus using sural nerve grafts, and at 8 months he underwent corrective surgery to improve the function of his left shoulder. The operations resulted in functional improvements; however, as of the date of hearing, Halle continued to suffer impairments of his left arm and hand, which are likely to be permanent, with notable atrophy within the left upper extremity. Apart from the physical impairment Halle exhibits in his left upper extremity, he is otherwise neurologically sound, without evidence of impairment in his right upper extremity or lower extremities; without evidence of cognitive delay; and without evidence of vision or hearing impairment. Accordingly, although Halle evidences a significant birth-related left brachial plexus injury, he is not, on balance, substantially physically impaired, and evidences no mental impairment. Therefore, for reasons appearing fully in the Conclusions of Law, the claim is not compensable, and it is unnecessary to address whether Halle's brachial plexus injury is, anatomically, an injury to the spinal cord.
The Issue Whether Jael Sutton, a minor, qualifies for benefits under Florida's Birth-Related Neurological Injury Compensation Plan (Plan).
Findings Of Fact Petitioner, Senboya Sutton, is the natural parent of Jael Sutton (Jael). At all times material, Senboya Sutton was an obstetric patient of Intervenor, Mark Davis, M.D., who was a "participating physician" in the Florida Birth-Related Neurological Injury Compensation Plan, as defined by section 766.302(7). Dr. Davis provided obstetrical services "in the course of labor, delivery and resuscitation in the immediate postdelivery period in a hospital," as related to this case. Jael was born on November 28, 2006. At birth, Jael weighed in excess of 2,500 grams. Jael was a single gestation. Jael was born live at St. Joseph's. St. Joseph's is a licensed hospital located in Tampa, Florida. The parties stipulated that all notice requirements of the statute have been met and that the notice requirement of section 766.316, is not at issue herein.2 Coverage is afforded by the plan for infants who suffer a "birth-related neurological injury," defined as an "injury to the brain . . . caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate postdelivery period in a hospital, which renders the infant permanently and substantially mentally and physically impaired." § 766.302(2), Fla. Stat. See also §§ 766.309 and 766.31, Fla. Stat.3 Herein, it is undisputed that Jael is "permanently and substantially mentally and physically impaired." Also, as described more fully hereafter, all the testifying experts concur that Jael's underlying brain damage did not result from a mechanical injury, but did result from sepsis and/or meningitis. However, it remains for determination whether or not Jael's brain injury and permanent and substantial mental and physical impairment occurred in the course of "labor, delivery, or resuscitation in the immediate postdelivery period," hereafter referred to as "the statutory period."4 The following terms were defined within this record: "Hypoxia" means "not enough oxygen." "Cerebral ischemia" means "not enough blood is getting to the brain." "Perfusion," for purposes of the instant case, means "to pass blood through the brain to ensure adequate oxygen." For her pregnancy with Jael, Ms. Sutton was first seen by Dr. Davis on August 17, 2006. Her delivery date was estimated as January 25, 2007. On November 17, 2006, a vaginal culture was taken of Ms. Sutton. On November 25, 2006, it was reported as "positive" for Group B streptococcus (Group B-strep), a genus of bacteria that causes life-threatening infections in newborn infants.5 Dr. Chalhub testified that intrauterine infections are the leading cause of cerebral palsy in term infants. Jael was not a term infant, but cerebral palsy is one of the conditions with which he has been diagnosed. On November 27, 2006, at approximately noon,6 Ms. Sutton presented to St. Joseph's. She complained of a single episode of leaking fluid at 1:02 p.m. Hospital records characterized this as the onset of labor, despite Ms. Sutton's denial of contractions. The plan of treatment was to rule out spontaneous rupture of the membranes. A nitrazine test was performed to identify amniotic fluid outside the amniotic sac, and was negative. Dr. Davis was present and ordered a non- stress test. At 1:34 p.m., Ms. Sutton again complained of leaking fluid and mucus discharge was noted. At 1:58 p.m., Dr. Davis reviewed the fetal monitor strip and discharged Ms. Sutton. At approximately 5:50 p.m., on November 27, 2006, Ms. Sutton presented to UCH. Her membranes were noted as possibly ruptured, and she complained of small gushes of fluid since noon. Again, a nitrazine test was performed and was negative. A speculum vaginal examination was performed; fetal heart rate was monitored; and a non-stress test was performed. She was discharged home upon phone orders of the "on-call" physician and advised to follow up with her obstetrician. The next morning, before 10:00 a.m., Dr. Davis did an ultrasound in his office. The ultrasound showed what was believed to be decreased amniotic fluid; a 34-week, four day gestation; and ruptured membranes. Due to the Group B strep and the gestation in excess of 34 weeks, Dr. Davis initiated a plan of care to induce labor and perform a vaginal delivery. Later on November 28, 2006, Ms. Sutton was admitted to St. Joseph's. Examination by speculum showed positive nitrazine and a copious amount of fluid in the vaginal vault, which, in hindsight after Jael's birth, Dr. Davis recorded as "probably a high leak to begin with." A fern test for nitrazine was positive. The cervix was 2-3 centimeters dilated. Labor steadily progressed. At 11:32 a.m., a nurse noted a non- reassuring fetal heart rate. At 11:47 a.m., Dr. Davis reviewed fetal heart rate tracings from his office. These were better, without decelerations. Ms. Sutton was placed in a left lateral position and continuous face mask oxygen was maintained. At 11:49 a.m., another sterile vaginal exam was performed. The amniotic fluid was noted to be clear and of normal quantity. At 11:54 a.m., due to a non-reassuring fetal heartbeat, Dr. Davis called for an immediate Caesarean section. Jael's fetal heart rate was 160, just prior to the C-section. A low transverse uterine incision was performed at 12:16 p.m., and Jael was delivered. Throughout the C-section, under general anesthesia, Ms. Sutton's oxygen saturation levels remained at 100. There is no record of trauma or of mechanical injury to Jael during labor or delivery. Indeed, the parties agree that there was no mechanical injury to Jael during labor or delivery. See infra. The delivery record does not show checks or fill-ins for the following, but the following is printed or typed in on the delivery room record form: "suction bulb, suction catheter, tactile stimulation, oxygen/PPV[7], intubated, neonatologist present." Apgar scores were taken at one and five minutes after Jael's birth.8 Jael's one minute Apgar score showed: Heart rate 2 > 100 Respiratory effort 0 none Muscle tone 1 some flexion Activity 0 none Color 0 blue/pale Total 3 Jael's five minute Apgar score showed: Heart rate 2 > 100 Respiratory effort 2 good cry Muscle tone 1 some flexion Activity 1 grimace Color 1 extremities blue Total 7 It is a point of contention among the parties as to whether Jael was intubated in the delivery room or in the Neonatal Intensive Care Unit (NICU). It is more likely that intubation and administration of nitrous oxide began after he was stabilized, as evidenced by the good Apgar score at five minutes after birth. The "good cry" recorded at five minutes of life (12:21 p.m.) suggests that Jael was breathing on his own at that point, had stabilized, and was not intubated before his admission to the NICU at 12:40 p.m. Jael's cord blood gas was collected at ten minutes after birth at 12:26 p.m. Its pH measured 7.206. A cord blood of 7.2 or higher suggests absence of metabolic acidosis. Metabolic acidosis is a sign of a pathological condition, not of a mechanical injury or of oxygen deprivation.9 At 12:32 p.m., Jael was transferred by isolette from the delivery/operating room to NICU due to "post C-section respiratory status." It would be fair to say that, at this point, if not sooner, Jael's care passed from the NICA participating physician, who provided obstetrical services to the mother, to other health care professionals in the NICU. At 12:40 p.m., on November 28, 2006, Jael was admitted to the NICU. The records show that ventilation support was given, and Jael was intubated. No physician associated with Jael's delivery or NICU care testified. However, Dr. Katz, a pediatric neurologist, opined without refutation that intubation at that stage might have been for ventilation, but could as easily have been to keep Jael's airway open because he was born prematurely. The reasons that were contemporaneously documented for Jael's admission to NICU were "premi, 34 weeks, R/O sepsis." This notation most probably means, "34 week gestational, premature infant; rule out sepsis." "'Sepsis' refers to the presence in the blood or other tissues of pathogenic microorganisms or their toxins; the condition associated with such presence."10 As described more fully hereafter, all testifying medical experts, regardless of specialty, agreed that in the NICU, Jael suffered from vascular inflammation, decreased blood pressure, and diminished perfusion caused by infection. Where they disagree is whether it was sepsis or meningitis which was ultimately responsible for Jael's diminished blood supply to the brain. "'Meningitis' is an inflammation of the meninges, usually by either a bacterium (bacterial meningitis) or a virus (viral meningitis)."11 Upon admission to the NICU at 12:40 p.m., Jael's oxygen saturation levels were at 93 per cent, and despite continuing very low blood pressures, his oxygen saturation levels remained in the 80's and 90's until 6:40 p.m., that evening. Jael was not assessed again after NICU admission until 1:20 p.m. At that time, a nurse noted that she was unable to obtain his blood pressure in either leg, although no reason was given. Dr. Katz testified that this could mean anything, up to and including an ill-fitting blood pressure cuff. Jael's bedside glucose (BSG) was recorded as 10, and 50cc of D10 bolus were ordered. At 1:44 p.m., on November 28, 2006, the BSG was recorded as 43 and another bolus was administered. At 1:58 p.m., November 28, 2006, a blood culture was drawn which was not reported back until the next day, but when it was reported back, the blood culture was read as positive for Group B strep. 37. At 2:00 p.m. and 2:05 p.m., on November 28, 2006, boluses and antibiotics were ordered, but one or more antibiotics were not administered to Jael for the first time until considerably later. At 2:05 p.m., on November 28, 2006, orders were written for survanta and dopamine. Dr. Katz opined that Jael was in septic shock at this time. At 2:16 p.m. on November 28, 2006, Neonatologist Dr. Amaizu entered an NICU admission note that Jael was lethargic with decreased reactions to stimuli. Capillary reflex was > 2 sec. Jael had decreased tone and activity. Although perfusion was decreased, his skin was pink. The active diagnosis at that point was "hypoglycemia, prematurity, respiratory distress syndrome, R/O sepsis newborn." At 2:25 p.m., an NICU nursing assessment was done. Jael was described as withdrawn, flaccid, lethargic with absent reflexes (suck, rooting, moro, and grasp). Central cyanosis (blueness in the torso) was observed. At 3:07 p.m., dopamine was administered. On the following day, November 29, 2006, Terry Declue, M.D., performed an endocrinology consult on Jael, who was on nitrous oxide via an oscillatory ventilator. He noted hypoglycemia. Perfusion was noted as good with capillary refill one second. The chest appeared clear, and Jael moved spontaneously. Dr. Declue's diagnosis was: Severe metabolic acidosis Lactic acidosis Respiratory failure Gram positive cocci sepsis Pulmonary hypertension On December 1, 2006, three days post-birth, a cranial neuro-sonogram was performed. At that time, hospital Radiologists Steen Mandel, M.D., and John Rasmussen, M.D., read the sonogram as normal. On December 4, 2006, four days post-birth, Jael underwent a lumbar puncture. His cerebrospinal fluid showed a white blood count of 185, reference 0-5. The consulting neurologist diagnosed Strep Group B sepsis and meningitis. On December 10, 2006, a second cranial ultrasound was done. This second sonogram was read by Michael Shaw, M.D. He recorded that ventricular size and configuration was normal, with no evidence of germinal matrix or inter-ventricular bleed, but the ventricles appeared slightly (not significantly) more prominent than the prior December 1, 2006, study. On December 15, 2006, an MRI was performed and interpreted by radiologist Elaine Engleman, M.D. Her impression was: Extensive cystic encephalomalacia[12] involving both cerebral hemispheres throughout all vascular territories. There is slightly less extensive involvement in the posterior cerebral artery territories. There is preservation of parenchyma involving the basal ganglia, thalami and brainstem. Jael was discharged from St. Joseph's on January 5, 2007, with a diagnosis of: Prematurity at 34 weeks gestational age Respiratory distress syndrome Neonatal depression Severe metabolic acidosis Patent ductus arteriosis Cholestasis Lactic acidosis Respiratory failure Meningitis that was treated for three weeks and supraventricular tachycardia On August 1, 2007, another MRI was performed on Jael's brain and interpreted by Radiologist, James Hanner, M.D. His report opined: FINDINGS: There is extensive cystic encephalomalacia seen throughout in the frontal, temporal, and parieto-occipital lobes associated with significant ex vacuo enlargement of the occipital horns, bilaterally, left greater than right. There is some sparing of the medial frontal accident, hemorrhage, or extra-axial fluid collection is identified. The hindbrain structures are normal without developmental anomaly. There is wallerian degeneration of the cerebral peduncles bilaterally. IMPRESSION: Extensive supratentorial systic encephalomalacia associated with ex vacuo enlargement of the lateral ventricles and occipital horns, left greater than right. The volume loss has progressed when compared to the earlier examination. Despite some variant medical testimony, across all experts, to the effect that Jael was probably infected with Group B-strep from his mother before labor, during labor, or during delivery, Intervenors collectively submit that, ". . . Jael Sutton did not suffer from oxygen deprivation during labor or delivery . . ." (proposed finding of fact 54 of Intervenors' proposed final order). Due to this admission and the other parties' similar positions, it is not necessary for the undersigned to resolve when labor began; when "active" labor began; when the amniotic fluid began to leak; or even whether Jael's delivery by C-section undermines any medical opinions rendered herein in terms of acquisition of bacterial infection during Jael's passage through the birth canal. Therefore, the issue is further narrowed to whether or not Jael suffered from oxygen deprivation "occurring in the course of . . . resuscitation in the immediate postdelivery period . . . which render[ed] the infant permanently and substantially mentally and physically impaired." The parties presented medical experts in a variety of fields who offered their opinions, within reasonable medical probability, as to what happened to Jael and within which periods of time. All experts testified by deposition, but the undersigned has had the benefit of viewing DVDs of the depositions of Dr. Robert Zimmerman and Dr. Mary K. Edwards- Brown. Michael Duchowny, M.D., a Florida-licensed physician, is a professor of neurology at the University of Miami Leonard Miller School of Medicine; a clinical professor of neurology at Florida International University College of Medicine; and senior attending physician at Miami Children's Hospital. He is board- certified in pediatric neurology, with special competence in child neurology, clinical neurology, and clinical neuro- physiology. He performed a medical examination of Jael on February 17, 2010, and reviewed the mother's and the child's medical records, including the ultrasound study of December 1, 2006, and the MRI scans of December 15, 2006, and August 1, 2007. He did not read the December 10, 2006, ultrasound. Dr. Duchowny's testimony confirmed, without equivocation, that Jael is tragically and profoundly permanently and substantially mentally and physically impaired. It was his ultimate opinion that Jael did not suffer a birth-related neurological injury due either to mechanical injury or deprivation of oxygen supply or blood flow to the brain within the statutory period. He reached this conclusion because, in his expert opinion, no impairment occurred during the statutory period. Dr. Duchowny did not see, on the films he reviewed, any sign of damage during the statutory period. He diagnosed the cause of Jael's multiple problems as meningitis, and opined, in pertinent part, as follows: Q: . . . Do you have an opinion, within a reasonable degree of medical probability, whether or not he had an impairment that was acquired during labor, delivery or post- delivery? . . . A: If we're going to define it as impairment, I would say, no. Q: So what you're saying is that no damage was done, even if he had the infection, right? A: I am saying that, because I don't see any indication of damage at that time. Q: . . . You don't find him -- you don't find that he had a mechanical injury; is that right? A: That's correct. Q: And you don't find that there was deprivation of blood flow or oxygen, correct? A: That's correct. (Depo. 33-34). Dr. Duchowny testified concerning the meningitis diagnosis as follows: A. . . . Meningitis means -- it specifically refers to a bacterial infection of the membranes covering the brain. These are anatomically called the meninges, so that in its strictest sense, a meningitis is an infection and an inflammation of the membranes covering the brain, but, in point of fact, it spreads from the membranes usually directly to the brain itself, and that's where the problems come in. . . . * * * I don't believe that Jael's brain damage was due to either a mechanical injury or oxygen- -deprivation of oxygen supply or blood flow to the brain. I think that Jael's brain damage is primarily due to the effects of meningitis. * * * . . . the MRI findings are consistent with severe bacterial meningitis, in this case, Group B strep meningitis. The findings, also, to me, are supported by the fact that if one looks at the clinical course of Jael, there really is no specific hypoxic or ischemic event that would be in the records to explain the findings on neuroimaging and the neurologic outcome. . . . So although one can see findings on MRI that are consistent with hypoxic and ischemic damage, for example, cystic encephalomalacia, if one looks at the totality of the picture, meaning, put the clinical events together with the neuroimaging findings and the neurologic examination, I think that this pattern of evidence all supports the fact that Jael's neurologic damage is primarily due to bacterial meningitis. (Depo. 20-26). Michael Katz, M.D., is a pediatric neurologist, and board-certified in pediatrics, pediatric neurology, and neuro- developmental disabilities. He is based at Hackensack University Medical Center, New Jersey. He examined Jael on September 14, 2009, and testified on behalf of Petitioners by a November 19, 2010, deposition. He considered the "resuscitative period" in Jael's case to be "until the Apgar is normalized at five minutes when the Apgar was seven," and opined that the injury to Jael's brain did not take place in that period. He concluded that the cause of Jael's permanent and substantial mental and physical impairment was a "strep B meningitis." More specifically, Dr. Katz testified: Q: In your opinion within a reasonable degree of medical probability, was there any injury to Jael Sutton's brain caused by oxygen deprivation occurring during labor or delivery or resuscitation in the immediate postdelivery period? A: No. * * * Q: What significant history did you elicit that leads you to reach that diagnosis and opinion of causation? * * * A: . . . First is that Mom was group B strep positive. The second was that mom had premature ruptured membranes. . . . Jael had a clinical deterioration, essentially went into shock and required pressors and resuscitation. And the ultimate, and probably most important fact, is when he was finally clinically stable, we were able to do a lumbar puncture, and we drew out group B strep spinal bacteria in his spinal fluid, along with a diagnosis of group B strep meningitis. (Depo. 11-12). Robert Zimmerman, M.D., is a professor of radiology of the division of neurosurgery at Children's Hospital of Pennsylvania. He has been chief of pediatric neurology there since 1989. He is licensed to practice medicine in Pennsylvania, New Jersey, and Israel, and has been board- certified in diagnostic radiology and neuroradiology. In Dr. Zimmerman's opinion, after having read the two ultrasounds (December 1, 2006 and December 10, 2006) and the two MRIs (December 15, 2006 and August 1, 2007) performed on Jael, the first ultrasound was abnormal and clearly showed decreased oxygen (hypoxia) and decreased blood flow (ischemia), and the remaining studies showed advancing stages of brain injury (the brain turning to "swiss cheese") due to lack of oxygen and lack of blood flow. This was cystic encephalomalacia. He acknowledged that a hypoglycemic event could possibly have contributed to the situation, but he perceived no traumatic event and no mechanical injury. As to timing, Dr. Zimmerman indicated that the progression of the ischemia possibly started intrauterine, even before delivery, but the best he could place a point of injury was, "in and around the time that the kid was being delivered, the day of birth or a little earlier, or perhaps right after birth, but somewhere in that vicinity . . . . Sometime around the 28th." He believed that hypoxic ischemia caused the holes in Jael's brain, and that the condition first began to develop more than 1-6 days before the first ultrasound of December 1, 2006. He indicated that sepsis was probably the cause of the oxygen insufficiency and ruled out bacterial meningitis, but he ultimately conceded he would defer those decisions to a clinician, such as a pediatric neurologist. Dr. Zimmerman's opinion is diminished by his vascillations on placing the time of injury and his disclaimers, and by there being no indication he reviewed any medical information on Jael other than the four films. Mary K. Edwards-Brown M.D., is a neuro-radiologist with a subspecialty interest in pediatric neuroradiology. She is board-certified in radiology and in neuroradiology. She is also a full professor of radiology at Indiana University and practices at Riley Children's Hospital, Riley, Indiana. She also teaches medical professionals at many levels, including preparation for specialty boards. Dr. Edwards-Brown also reviewed the history and all four of Jael's films (December 1, 2006; December 10, 2006; December 15, 2006, and August 1, 2007). She, unlike Dr. Zimmerman, considered the first ultrasound to be normal. In the December 10, 2006, MRI, she found non-specific brain damage by tissue destruction. In the December 15, 2006, MRI, she, like Dr. Zimmerman, found massive brain damage and diffused cystic encephalomalacia, which she also considered non-specific. According to Dr. Edwards-Brown, the most common cause for this condition is that insufficient oxygen was getting to the brain, which can occur by not enough oxygen being present, by infection, or by trauma. Dr. Edwards-Brown ultimately opined that: . . . [Jael] was suffering from a profound meningitis, which caused the pattern of hypoxic-ischemic encephalitis -- encephalomalacia. And it was a mechanism of meningitis that induced hypoglycemia and brain injury that happened after this child was born. * * * Given that Jael was born with Apgars of 3 and 7, and a pH of 7.2, those are signs that -- most children who have those Apgars and that non-acidotic pH at birth generally do very well, and certainly don't have a pattern of injury as we've seen here. And given the fact that the ultrasound of December 1st looks normal to me it is my opinion that this injury occurred after the time of birth [November 28, 2006]. And most likely, the bulk of the injury occurred after December 1st, that first ultrasound that looks so very normal. Doctors Duchowny, Katz, and Edwards-Brown concurred, in varying terminology, that Jael's situation was a slow- evolving brain injury not consistent with a sentinel hypoxic insult occurring during resuscitation in the immediate postdelivery period. Dr. Zimmerman also could not point to any specific sentinel event. Elias Chalhub, M.D., testified by a deposition taken November 26, 2010. Dr. Chalhub is board-certified in pediatrics, psychiatry, and neurology, but he has not done research or published in over 20 years. Based on a records review, and without examining Jael, he testified that Jael's Group B strep sepsis occurred within an hour and a half of birth when the child was in the NICU in septic shock. He noted the records of Jael's pale, blue color (cyanosis) but also agreed that the baby had reasonably good Apgars and normal cord gas before transfer to the NICU. He stated Jael deteriorated rapidly after the good Apgars, which, in his opinion, is consistent with septic shock. However, Dr. Chalhub conceded that the baby was stable at five minutes after birth; that there was nothing in the nursing notes at 1:00 p.m., on December 28, 2006, that alerted to a problem; that there was no indication about an inability to get blood pressures before 1:20 p.m.; that thereafter, the baby became hypotensive, and that the first abnormal blood pressure reading was at 1:52 p.m., an hour and 36 minutes after birth. Dr. Chalhub opined that between birth at 12:16 p.m. and 2:00 p.m., on November 28, 2006, there was sepsis and decreased perfusion that resulted in Jael's injury. He was satisfied that the Group B-strep, which may have been acquired before labor or during birth, resulted in sepsis and that the brain injury occurred before the sepsis became meningitis, but conceded the meningitis, which came later, could have contributed to Jael's brain damage. He stated he did not believe that hypoglycemia, detected at 1:20 p.m., contributed to the brain damage. That said, Dr. Chalhub, in asserting compensability, also set the "immediate postdelivery period in a hospital" at an arbitrary "six hours from birth," without even relating the six hour period to acts of "resuscitation" or to the facts of this case. He claimed "six hours" would be what neonatologists would say constituted the "immediate post-resuscitative period," but he quoted no neonatal authority for the proposition. Clearly, his arbitrary concept is not the understanding of the greater medical community as evidenced by the other testifying physicians, nor is it the status of Florida law.13 Accordingly, I have discounted his opinion that the oxygen deprivation occurred during the statutory period. It might have been helpful to have heard testimony from a perfusionist or neonatologist, but herein radiologists' opinions have been compared with each other and neurologists' opinions have been compared with those of other neurologists. Dr. Chalhub's opinion is less persuasive than some other witnesses for the reasons related supra. The opinions of the physicians who actually examined Jael are more persuasive than those of physicians who only did a records review. Finally, the logic and reasoning of all experts have been compared and weighed and one common theme appears: whether characterized as "sepsis" or "meningitis," the Group B-strep resulted in a plethora of diagnoses, culminating in ultimate brain cell death. Within these parameters, and upon the credible evidence as a whole, it is found that more likely than not, Jael did not suffer brain injury due to oxygen deprivation that occurred during labor, delivery or resuscitation in the immediate postdelivery period in a hospital. Rather, it is more likely than not that Jael suffered brain damage after he was initially stabilized and after he was removed to the NICU due to his premature birth status. Based on the credible evidence as a whole, it appears that wherever and whenever Jael was intubated, he probably was not intubated until after the Apgars and after the immediate resuscitative period ended. Due to Jael's "good cry" immediately after delivery, the increasingly good Apgars, the good cord blood report, and the fact that there was no indication of oxygen deprivation to the brain at least until the first ultrasound of December 1, 2006, three days after delivery, the more compelling evidence supports a finding that Jael did not suffer from oxygen deprivation during labor or delivery and did not suffer injury to the brain during that period, either. As to his intubation in NICU, it is as likely that his airway was being protected by intubation as it is that he suffered any problem breathing or any oxygen deprivation before 2:00 p.m., on November 28, 2006, when he went into shock. Accordingly, the record fails to support a finding that there was an hypoxic or ischemic event during the statutory period (labor, delivery, or resuscitation in the immediate postdelivery period in a hospital). Alternatively, it is conceivable, but not proven, that Jael suffered oxygen deprivation at some unspecified point in time which occurred after 2:00 p.m., on December 28, 2006, and after he had arrived in NICU, which still is not within the statutory period. Since both the oxygen deprivation and the injury cannot be placed in the statutory period, Petitioners cannot prevail.
Findings Of Fact Alexander was born on August 28, 2015, at South Miami Hospital. Alexander was a single gestation, weighing over 2,500 grams at birth. NICA retained Donald Willis, M.D., an obstetrician specializing in maternal-fetal medicine, to review the medical records of Alexander and his mother, Petitioner Evelyn Machado Valdes, 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 his report, dated February 19, 2018, Dr. Willis set forth the following: In summary, umbilical cord prolapse occurred during labor. Emergency Cesarean section was done with delivery of a healthy newborn. The baby was not depressed at birth. Apgar scores were 9/9. No resuscitation was required. The baby left the delivery room stable and well. Episodes of cyanosis occurred several hours after birth. Cerebral infarction was diagnosed by MRI. The baby suffered a stroke at some time around the episodes of cyanosis that occurred several hours after birth. This would be well after the post-delivery resuscitation period. The baby was born active and required no resuscitation at birth, indicating there was no oxygen deprivation during labor, delivery of [sic] the post- delivery period. * * * 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. The baby did suffer a stroke during the perinatal period, but this was not related to oxygen deprivation or mechanical trauma during labor, delivery or the immediate post-delivery period. Dr. Willis affirms in his amended affidavit, dated September 24, 2018, the above-quoted opinions from his report and further opines that: [I]n that there was no oxygen deprivation or mechanical injury occurring in the course of labor, delivery or resuscitation in the immediate post-delivery period in this Hospital, then accordingly, there was no causal event which would have rendered Alexander Pinera permanently and substantially mentally and physically impaired as a result of the same. NICA also retained Michael S. Duchowny, M.D., a pediatric neurologist, to review the pertinent medical records, conduct an Independent Medical Examination (IME) of Alexander, and opine as to whether Alexander suffers from a permanent and substantial mental and physical impairment as a result of a birth-related neurological injury. Dr. Duchowny reviewed the medical records, obtained historical information from Alexander’s mother, Evelyn Machado, and performed an IME on June 13, 2018. In a report authored after the IME, Dr. Duchowny summarized his findings, in pertinent part, as follows: In SUMMARY, Alex’s neurological examination reveals subtle right upper extremity weakness characterized by left hand preference and posturing of his right upper extremity while walking. There is no objective weakness and his fine motor coordination is preserved. His speech is age-appropriate. * * * Although Alex had a major cerebral vascular accident that affected his left cerebral hemisphere, he has made a remarkable recovery and now evidences only minimal deficits on his neurological examination. In view of his stable general physical and neurological status at birth, it is most likely that the cerebral vascular accident occurred prior to the onset of labor. * * * Based on the medical record review and today’s evaluation, I am not recommending Alexander for inclusion in the NICA program. NICA’s Motion for Partial Summary Final Order also relies upon the attached affidavit from Dr. Duchowny, dated September 4, 2018. In his affidavit, he affirms his findings and opinions contained in his report to a reasonable degree of medical probability. A review of the file reveals that no contrary evidence was presented to dispute the findings and opinions of Dr. Willis and Dr. Duchowny. Their opinions are credited.
The Issue Whether Eman Mustafa, a minor, qualifies for coverage under the Florida Birth-Related Neurological Injury Compensation Plan (Plan). If so, whether the hospital and the participating physician gave the patient notice, as contemplated by Section 766.316, Florida Statutes, or whether any failure to give notice was excused because the patient had an "emergency medical condition," as defined by Section 395.002(9)(b), Florida Statutes, or the giving of notice was not practicable.
Findings Of Fact Stipulated facts Shiren Mustafa and Nehad Mustafa are the natural parents and guardians of Eman Mustafa, a minor. Eman was born a live infant on February 22, 2002, at University Community Hospital, a hospital located in Tampa, Florida, and her birth weight exceeded 2,500 grams. The physician providing obstetrical services at Eman's birth was Caryn L. Bray, 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. Eman's birth and immediate postnatal course At or about 8:00 p.m., February 21, 2002, Mrs. Mustafa, with an estimated delivery date of February 15, 2002, and the fetus at 40 6/7 weeks' gestation, was admitted to University Community Hospital, for induction of labor, and proposed vaginal birth, after prior cesarean section (VBAC). At the time, Mrs. Mustafa's membranes were intact; irregular contractions were noted; vaginal examination revealed the cervix closed, effacement at 60-70 percent, and the fetus at station -2; and fetal monitoring revealed a reassuring fetal heart rate, with a baseline in the 130-beat per minute range. At 9:00 p.m., Cervidil was placed to soften the cervix overnight, and by 7:15 a.m., February 22, 2002, vaginal examination revealed the cervix at 1-2 centimeters dilation, effacement at 90 percent, and the fetus at station -1. Cervidil was removed; at 7:40 a.m., the membranes spontaneously ruptured, with clear fluid noted; and Pitocin was started to augment labor. Fetal monitoring contained to reveal a reassuring fetal heart rate. Mrs. Mustafa's labor rapidly progressed and by 8:30 a.m., vaginal examination revealed the cervix at 5 centimeters,3 effacement complete and the fetus at station 0, and by 9:30 a.m., vaginal examination revealed complete dilation and effacement, and the fetus at station +2. Late decelerations were also noted at 9:30 a.m., but fetal heart rate was otherwise reassuring. Dr. Bray was paged at 9:32 a.m., and returned the page at 9:39 a.m. At the time, Dr. Bray was notified of Mrs. Mustafa's status and requested that the patient start pushing. However, due to the low station of the fetus, staff requested Dr. Bray's presence for pushing, and Dr. Bray stated she would be bedside in approximately 10 minutes. Thereafter, at 9:58 a.m., further decels were noted, and Pitocin was stopped. At 9:59 a.m., Dr. Bray was noted at bedside, oxygen was applied, fluid bolus started, and fetal heart rate decels to 60 beats per minute were documented. Thereafter, at 10:03 a.m., Mrs. Mustafa was pushing, complaining of pain when abdomen palpated, and fetal heart rate in the 50-beat per minute range was noted. Then, at 10:07 a.m., fetal heart rate in the 50s was noted, with brief accelerations to the 110-beat per minute range, and Dr. Bray requested a Kiwi vacuum. At 10:09 a.m., Kiwi vacuum-assisted delivery, with patient pushing, proved unsuccessful, and fetal heart rate was noted in the 110-beat per minute range, with deceleration back to the 60-beat per minute range. At 10:11 a.m., Dr. Bray requested fundal pressure, with patient pushing, but again Kiwi vacuum-assisted delivery was unsuccessful, despite three attempts. Medela vacuum was called for and at 10:17 a.m., two attempts at delivery with the Medela vacuum and fundal pressure proved unsuccessful. Then, at 10:19 a.m., with fetal heart rate remaining in the 60-beat per minute range, a stat cesarean section was called for non-reassuring fetal heart rate and suspected uterine rupture. At 10:22 a.m., Mrs. Mustafa was taken to the operating room, where she was admitted at 10:25 a.m.; surgery started at 10:30 a.m., at which time uterine rupture was confirmed; and Eman was delivered at 10:32 a.m., with Apgar scores of 1, 3, and 6, at one, five, and ten minutes respectively.4 According to the medical records, Eman required resuscitation at birth, with tracheal intubation, IPPV, and cardiac massage, and was then transferred to the neonatal intensive care unit (NICA), where she developed spontaneous respirations, and within two to three hours was weaned from the ventilator. Eman's subsequent newborn course was without incident or evidence of residual effects of birth trauma, and she was discharged with her mother on February 25, 2002. Eman's Discharge Summary included the following observations: PHYSICAL EXAMINATION: A term female infant, weight 3329 grams, length 51 cm, and hip circumference 32 cm. Temperature 97.3, heart rate 158, respiratory rate 62, blood pressure 51/48. HEENT: Normocephalic. Eyes examined at discharge: Pupils were reactive and the red reflex seen. No nasal flaring. Neck supple. Lungs: No retractions. Good air entry. Heart regular rate and rhythm. No murmur. Abdomen soft, no masses, three-vessel cord. Genitalia: Female. Extremities: Moving all limbs, hips stable. No rashes. Neurological: Good tone. INITIAL IMPRESSION: Term female infant. Perinatal depression. Maternal uterine rupture. Respiratory distress. At once (STAT) cesarean section. INITIAL TREATMENT: NICU admission. Pulse oximetry monitoring. Conventional mechanical ventilation. Nothing by mouth. Intravenous fluids. Sepsis workup. Antibiotics. Chest x-ray. PROGRESS: Respiratory: The infant was extubated and weaned to room air within approximately two to three hours of admission. Initial chest x-ray was not significant. Rule out sepsis: The infant was treated with antibiotics; namely, ampicillin and gentamicin for 48 hours. These were discontinued when the cultures remained negative. Fluids and electrolytes: On admission, the infant was given early intravenous fluids, approximately 24 to 48 hours enteral feeds were begun and increased progressively. At the present time the infant is breastfeeding only. She is voiding well, passing stools. Neurological: The infant has good tone and good reflexes, no clonus, and appears to be neurologically normal. SUMMARY: This is a term female infant who was delivered after having maternal uterine rupture. The infant did require neonatal resuscitation but recovered very quickly. At the present time the infant is doing well and feeding well. FINAL DIAGNOSIS: Term female infant. Cesarean section. Perinatal depression. Rule out sepsis. Respiratory distress. Eman's subsequent development Eman's early development was apparently without significant concern until approximately 19 months of age, when she was referred by her pediatrician (Issaam Albanna, M.D.) to Jose Ferreira, M.D., a physician board-certified in neurophysiology and neurology with special qualification in child neurology, for evaluation concerning "some gait disturbance with falling and some coordination problems." Pertinent to this case, Dr. Ferreira reported the results of his initial evaluation of October 6, 2003, as follows: I had the pleasure of seeing Eman for initial evaluation today accompanied by her mother and aunt. The main concern is some gait disturbance with falling and some coordination problems. They report that she started walking somewhat late at 14-15 months and was doing better initially and then seems to be falling more frequently recently and will walk on her toes at times. There is also some deficits with the coordination where she seems to be "clumsy" at times, hands "clinched" frequently and her muscles "give out" on her apparently more frequently then expected for age. She has been developing speech with about 5 words at this point. She tends to drool frequently She is potty training currently as she starts to talk with 5-6 words vocabulary . . . . PAST MEDICAL HISTORY: She was born at full term pregnancy. Birth weight was 7 lb 8 ounces. There was some traumatic delivery as she describes it with uterine rupture and labor requiring a stat cesarean section. She went home with her mother. There was no other problems noted initially. * * * GENERAL PHYSICAL EXAMINATION: HC: 45 cm (5th percentile) WT: 23 lb HR: 90 and regular. HEENT: Unremarkable. Normocephalic. . . . The extremities have full range of motion with no edema, deformities or joint tenderness. The midline back shows no midline defects and no point tenderness to percussion. The skin shows no neurocutaneous findings of significance and there was no dysmorphic features. NEUROLOGICAL EXAMINATION: Shows she was alert. She was initially showing significant stranger anxiety and then was more comfortable with the examiner as the interview took place. She was able to follow some simple commands from her mother. She did not say any words during the examination. The cranial nerve examination revealed full extraocular movements and visual fields full to confrontation. The pupils were equal and reactive. The funduscopic exam showed bilateral red reflex. The face is symmetric and the tongue midline with no fasciculations. There was some degree of drooling noted. Her motor exam shows she had no focal weakness. There is no significant increased resistance to pass of motion other than possibly the right upper extremities. She tended to maintain her hands fisted with some cortical thumbs at times specially when she walked. The gait shows she was somewhat stooped forward to a mild degree but otherwise wide based appropriate for age. She tended to fall occasionally. There was no asymmetry of the use of her extremities otherwise except that she tended to hold the right arm more flexed and the right hand more frequently closed and pronated. The deep tendon reflexes showed 2+. There is no sustained ankle clonus. The plantar responses were extensor bilaterally. Gait and coordination showed there was no tremors and no ataxia [failure of musculature coordination]5 of significance other than the tendency to fall which was somewhat limited coordination. The plantar responses were extensor bilaterally. IMPRESSION: 1. Gait disturbance associated with a mild degree of incoordination with her age with some mild upper motor neuron dysfunction signs as described above in the neurological examination. * * * RECOMMENDATIONS: She will have an MRI of the brain without contrast. She will have a metabolic screening including serum amino acids, ammonia levels, thyroid functions studies, total carnitine levels, ammonia and lactate and CPK levels. She will be seen for follow up here in approximately one and a half to two months or earlier if there is any acute changes. Physical and occupational therapy may be recommended at this point . . . . (Petitioners' Exhibit 2). Eman was reevaluated by Dr. Ferreira on December 15, 2003, and he reported the results of that visit, as follows: I had the pleasure of seeing Eman for follow up today accompanied by her parents. As you know, she has a history of difficulties with her gait and some developmental delay and coordination difficulties. She had an MRI of the brain, which was normal with the exception of some sinusitis. She also had a metabolic screen and had elevated T4[,] and T3 and TSH was normal. She continues having difficulties with her gait and coordination. She has had some drooling at times. Her speech has been somewhat delayed and she has approximately 10-15 word vocabulary but difficult to understand and does not show any signs to suggest regression. She has been sleeping and eating well. * * * HEENT: Unremarkable. . . . The extremities had full range of motion and no edema. NEUROLOGICAL EXAMINATION: She was alert and friendly. She was cooperative. Cranial nerve exam revealed full extraocular movements and visual fields grossly full to confrontation. The pupils are equal and reactive. The funduscopic exam shows bilateral red reflex. The face is symmetric and the tongue was midline with no fasciculations. The motor exams shows she had some difficulties with fine motor coordination. She did not have a good pincer grasp and she tended to keep her hands mostly in a pronated position and somewhat flexed at the elbow and especially when she walked. Her muscle tone was minimally increased in all extremities. Deep tendon reflexes were 2+/2+. The plantar responses were extensor bilaterally. Her gait was minimally spastic with a slightly wide base. She tended to walk somewhat stood forward to a mild degree. When she was sitting she also had some mild degree of truncal ataxia. IMPRESSION: History of developmental disorder with mild speech and language delay as well as some drooling. Mild degree of spasticity with gait disturbance. There is history of sinusitis. RECOMMENDATIONS: As her MRI did not show any intracranial pathology an EEG will be done to evaluate for any encephalopathic changes. She was referred to occupational, speech and physical therapy. The thyroid function (T4 was mildly elevated) will be repeated. She will be seen for follow up here in three to four months or earlier if there is any acute changes . . . . (Petitioners' Exhibit 2). Eman was last evaluated by Dr. Ferreira on February 11, 2004, and he reported the results of that visit, as follows: I had the pleasure of seeing Eman for follow up today accompanied by her parents for a history of gait disturbance with some developmental delay and coordination difficulties. She had an EEG done today which showed a mild abnormality with the right occipital rhythm being slightly lower voltage than the left. The EEG was otherwise normal. She is now in physical, occupational and speech therapy. This just started so it is difficult to say whether or not improvement has been noted. Her parents feel however that she has improved. She is learning new words and her parents feel that she is steadily showing improvement. She is falling still but is moving around better than she has previously. They also feel her drooling has improved. She is eating and sleeping well and they have no new concerns today. * * * HEENT: Unremarkable. . . . Extremities had full range of motion. NEUROLOGICAL EXAMINATION: She is awake and alert. She is very cooperative and friendly. She was speaking at times and was smiling. Cranial nerve and motor exams were unchanged from the last evaluation. Her pincer grasp was still not as good as expected for her age and she tended to keep her hands pronated when walking. Her muscle tone was still mildly increased. Deep tendon reflexes were 2+ and she was walking with a slightly wide based gait for age. She was sitting without assistance for short periods of time today but continued with a mild degree of truncal ataxia. RECOMMENDATIONS: The thyroid panel will be repeated as it was requested at the last visit but unable to be completed.[6] She will continue in the therapies . . . . (Petitioners' Exhibit 2). According to Dr. Ferreira, as of the last time he saw Eman (February 11, 2004) she was still showing some neurologic deficits, which he described as a mild degree of spasticity (increased muscle tone), with gait disturbance; mild upper motor dysfunction, with a less than age-appropriate pincer grasp and tendency to pronate her hands when walking; and a mild speech and language delay. (See Dr. Ferreira's reports of December 15, 2003, and February 11, 2004, supra, and Petitioners' Exhibit 2, pages 15-21, 28-32, and 42). As for permanency, Dr. Ferreira declined (given the limited contact he had with Eman) to offer an opinion regarding the significance of any dysfunction that might persist. Moreover, Dr. Ferreira, who was not familiar with Eman's birth records or those medical records that predated his evaluation of October 6, 2003, offered no opinion, within a reasonable degree of medical certainty, as to the likely etiology of Eman's neurologic defects (i.e., whether they resulted from brain injury caused by oxygen deprivation or mechanical injury occurring during labor delivery or resuscitation, or another etiology) or whether Eman suffered any mental impairment. Subsequent neurologic evaluations On February 23, 2005, Eman was, at NICA's request, evaluated by Michael Duchowny, M.D., a pediatric neurologist associated with Miami Children's Hospital. Dr. Duchowny reported the results of his evaluation, as follows: PRE-AND PERINATAL HISTORY: Eman was born in Tampa at University Hospital after a full term gestation. Her birth weight was 7 pounds 9 ounces, and she remained in the nursery for three days. Eman walked at eighteen months and said single words at two years. She is just beginning toilet training. She is fully immunized and has no known allergies. She has never undergone surgery and has not been hospitalized after birth. PHYSICAL EXAMINATION reveals an alert, well- developed and well-nourished, cooperative 3- year-old girl. Eman weighs 36 pounds and is 45 inches tall. The skin is warm and moist. There are no neurocutaneous stigmata . . . The spine is straight. The head circumference measures 45.8 centimeters, which is below the 3rd percentile for age. There are no cranial or facial anomalies or asymmetries. The neck is supple without masses, thyromegaly or adenopathy. The cardiovascular examination is unremarkable, and the lung fields are clear. There is no palpable abdominal organomegaly. Peripheral pulses are 2+ and symmetric. Eman's NEUROLOGIC EXAMINATION reveals her to be socially interactive and cooperative. She has a good attention span and is quite inquisitive. She smiles frequently. She is able to understand commands and completes them very clearly. She is quite interactive playing games. She knows body parts. She is behaviorally intact. Cranial nerve examinations reveal full visual fields to confrontation testing. The pupils are 3mm and briskly reactive to direct and consensually presented light. There are full and conjugate extraocular movements. Funduscopic examination is unremarkable with well-defined optic disc margins. There are no significant facial asymmetries. The tongue movements are poorly coordinated. Drooling is noted intermittently. Motor examination reveals static hypotonia with a mild increase in tone in all extremities. There are no contractures and there is full range of motion in all joints. The gait is complex with the left heel being slightly elevated with a mild degree of circumduction at the hips and internal rotation at the ankles. Deep tendon reflexes are 1+ in the upper extremities, 3+ at the knees, and 1+ at the ankles. Plantar responses are downgoing. Sensory examination is intact to withdrawal of all extremities to stimulation. Neurovascular examination reveals no cervical, cranial or ocular bruits and no temperature or pulse asymmetries. (Petitioners' Exhibit 3). Based on his neurologic evaluation and review of the medical records, Dr. Duchowny was of the opinion that Eman's impairments were most likely developmentally based (the product of atypical brain development), as opposed to birth trauma (brain injury caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery or resuscitation). In so concluding, Dr. Duchowny noted that following delivery, Eman's hospital course was inconsistent with traumatic brain damage (there being an absence of significant prolonged respiratory depression, an absence of systemic organ involvement, and an absence of seizure activity), and her MRI scan of November 13, 2003, was normal. Dr. Duchowny also noted that Eman's presentation on February 23, 2005, with a pattern of immature muscle control and expressive language delay, was typical of children with developmental disabilities, as opposed to disabilities associated with birth trauma. Finally, Dr. Duchowny was of the opinion that Eman's expressive language delay was mild to moderate, and her motor disability was moderate, as opposed to substantial, and that her condition was likely to improve with time. (Petitioners' Exhibit 4; Respondent's Exhibit 1). Subsequently, on March 11, 2005, Eman was, at University Community Hospital's request, evaluated by S. Parrish Winesett, M.D. a physician board-certified in pediatrics and neurology with special qualification in child neurology. Dr. Winesett reported the results of his evaluation, as follows: PHYSICAL EXAMINATION: General: Shows a young lady who is alert, who is quite interactive. She smiles easily. She has no obvious dysmorphic features. She has normally placed eyes, ears, nose, philtrum and mouth. Her mental status is that she said single words during my exam. I did not really hear her say sentences. She was rather quiet for the most part. She seemed to follow directions well. Cranial nerve exam showed her pupils were equal and responsive to light. She seemed to have full visual fields. Her extraocular eye movements were intact. Range of motion in all directions was full. Face was symmetrical with good facial movements in both the upper and lower face. Tongue was midline without any fasiculations. Palate raised symmetrically. She shrugged her shoulders will. Motor exam seemed to show that she was strong in all four extremities. I could not get her to fully resist me and give her full effort in trying to resist me, but she did seem to be fairly strong in what resistance I could elicit. She does not seem to have any obvious atrophy of the muscles. She seemed to have normal tone and bulk. In particular, I did not detect any asymmetry of tone nor did I detect any hypertonia. Reflexes in the upper extremities were normal in the biceps, brachial radialis and triceps. In the lower extremities, she did not have any pathologic increase in reflexes, but her patella and ankle reflexes were brisk. Her motor coordination showed that in reaching with both hands, she seemed to be somewhat jerky and has a very slow approach in reaching for my tape measure. She did not seem to be particularly adept at pushing the buttons and pulling the tape as I would expect a child of three to be. She seemed to be very slow. Finger tapping also seemed to be slow and somewhat labored. She did not diminish her amplitude as she tapped. Sensation was not extensively tested, but she did seem to acknowledge being touched in all four extremities in a normal fashion. Her gait was clearly abnormal. Her hands while sitting never showed any adduction of the thumbs within the palms. When she walked, she immediately assumed a posture in which she pulled her arms close to her side, bent her elbows and brought her thumbs within her palm. This was seen each time she started to walk. She did not circumduct her legs but instead seemed to drag her lower extremities and have an almost slapping motion of her feet as she pulled her legs forward. She did not particularly scissor while she was walking. She did not space out her gait while she was walking. * * * Review of the medical records provided to me of both the child, as well as the mother . . . showed the following. The child was born on February 22, 2002 as the product of a 41 week pregnancy. There was an attempted vaginal birth after previous C-section. At approximately 10:02, the fetal heart rate was noticed to be decelerating. The obstetrician was called at that time. The child had heart deceleration during this period that was noted in the nurses notes to be down in the 50's and noted in the physician's notes to be in the 70's. The child was then taken to the operating room where the child was born at approximately 10:32. The child, at that time, was handed over to the neonatal resuscitation team who started resuscitation effort and gave the child Apgar scores of 1, 3 and 6 at 1, 5 and 10 minutes. The patient had been intubated by the 3rd Apgar score. The child was taken back to the NICU where at 10:45, a blood gas was performed which showed a pH of 7.31, a PC02 of 22 and a base excess of -18. The child recovered quite quickly and was extubated in approximately two hours. Review of the operating notes showed that there was reported 200 to 300 cc of blood in the uterus and that there was a uterine rupture noted by the physicians at the operation. The child was discharged from the NICU on February 25, 2002 with the neurological exam reported to be normal. The child has subsequently been seen by Dr. Jose Ferriera for the same complaints that they presented to me with. He has done an MRI which was read as normal by the Tampa Children's Hospital radiologist. Thyroid function tests were ordered and showed a mild elevation of T4. . . . A speech therapy evaluation including the Rossetti Infant Toddler Language Scale showed that she scored at the 15 month range at the age of 23 months for her speech skills. There was apparently some splintering of the scoring but mostly within the 15 to 18 month range. An auditory comprehension subtest, she scores at 23 months which is normal. She is also noted to have some oral motor speech difficulties. Physical and occupational therapy evaluations were reviewed but not as significantly to the data. IMPRESSION: Eman is a young lady who is presenting with predominantly problems in gait disturbance, as well as speech problems. Many of her speech problems could be related to problems in the coordination of her speech. There is a mild increase in reflexes in the lower extremities; however, it does not appear to be a significant degree of hypertonia. Overall, this child appears to have predominant problems with dyscoordination. This is not a typical presentation for a neonatal hypoxic ischemic encephalopathy syndrome. In addition, the fact that the child recovered so quickly and was extubated within two hours and was discharged within two days makes it highly unlikely that the hypoxia suffered at birth is the cause of the neurologic syndrome. (Petitioners' Exhibit 3). Based on his neurologic evaluation and review of the medical records, Dr. Winesett was of the opinion that, while of unknown etiology, it was unlikely Eman's neurologic problems were related to birth trauma. Dr. Winesett also described Eman's motor difficulties as moderate, as opposed to substantial, and offered no opinion regarding her cognitive function. (Petitioner's Exhibit 3, pages 18, 19, 22-26, and 36). Coverage under the Plan Pertinent to this case, coverage is afforded by the Plan for infants who suffer a "birth-related neurological injury," defined as an "injury to the brain . . . caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate postdelivery period in a hospital, which renders the infant permanently and substantially mentally and physically impaired."7 § 766.302(2), Fla. Stat. See also §§ 766.309(1) and 766.31(1), Fla. Stat. The etiology and significance of Eman's impairments Here, among the physicians who have examined Eman, and who were particularly qualified to address the etiology and significance of her impairments, none concluded that Eman's impairments most likely resulted from brain injury caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitating in the immediate postdelivery period in the hospital, or that Eman was permanently and substantially mentally and physically impaired. See, e.g., Wausau Insurance Company v. Tillman, 765 So. 2d 123, 124 (Fla. 1st DCA 2000)("Because of the medical conditions which the claimant alleged had resulted from the workplace incident were not readily observable, he was obliged to present expert medical evidence establishing that causal connection."); Ackley v. General Parcel Service, 646 So. 2d 242 (Fla. 1st DCA 1995)(determining cause of psychiatric illness is essentially a medical question, requiring expert medical evidence); Thomas v. Salvation Army, 562 So. 2d 746, 749 (Fla. 1st DCA 1990)("In evaluating medical evidence, a judge of compensation claims may not reject uncontroverted medical testimony without a reasonable explanation."). Therefore, the proof fails to support the conclusion that Eman suffered a "birth-related neurological injury," as required for coverage under the Plan. The notice provisions of the Plan Given that Eman did not suffer an injury compensable under the Plan, it is unnecessary to address whether the healthcare providers complied with the notice provisions of the Plan. See, e.g., Galen of Florida, Inc. v. Braniff, 696 So. 2d 308, 309 (Fla. 1997)("[A]s a condition precedent to invoking the Florida Birth-Related Neurological Injury Compensation Plan as a patient's exclusive remedy, healthcare providers must, when practicable, give their obstetrical patients notice of their participation in the plan a reasonable time prior to delivery."); O'Leary v. Florida Birth-Related Neurological Injury Compensation Association, 757 So. 2d 624, 627 (Fla. 5th DCA 2000)("We recognize that lack of proper notice does not affect a claimant's ability to obtain compensation from the Plan. However, a healthprovider who disputes a plaintiff's assertion of inadequate notice is raising the issue of whether a claim can only be compensated under the plan.").
The Issue At issue in this proceeding is whether Shalyn L. Hayman, 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 Shalyn L. Hayman (Shalyn) is the natural daughter of Rosalee Hayman and Basil Hayman. She was born a live infant on January 6, 1993, at St. Mary's Hospital, a hospital located in West Palm Beach, Palm Beach County, Florida, and her birth weight was in excess of 2,500 grams. The physician providing obstetrical services during the birth of Shalyn was John Pauly, M.D., who was, at all time material hereto, a participating physician in the Florida Birth- Related Neurological Injury Compensation Plan, as defined by Section 766.302(7), Florida Statutes. The parties have stipulated and the proof demonstrates, that Shalyn is permanently and substantially mentally and physically impaired. What is at issue is the cause and timing of the event or events giving rise to such impairment or, stated differently and pertinent to these proceedings, whether Shalyn's impairment resulted from an "injury to the brain or spinal cord . . . caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery or resuscitation in the immediate post-delivery period in the hospital." Section 766.302(2), Florida Statutes. Mrs. Hayman's antepartum course and Shalyn's delivery Mrs. Hayman's pregnancy was essentially uncomplicated, except for being post-term. In this regard, it is noted that Mrs. Hayman's due date was established as December 25, 1992, at forty weeks gestation, and that when delivered on January 6, 1993, Shalyn was almost two weeks overdue, a high risk situation. At or about 5:30 a.m., January 6, 1993, Mrs. Hayman presented to St. Mary's Hospital. At the time, Mrs. Hayman was experiencing mild, irregular contractions, and vaginal examination revealed the cervix to be at 1 to 2 centimeters, effacement at 50 percent, and the fetus at station -1. The membrane was noted to be intact, and monitoring revealed a fetal heart tone in the 130's, with poor variability and no observed reactivity. Given the circumstances, Mrs. Hayman was admitted to the labor and delivery area at or about 6:00 a.m. At or about 7:50 a.m., Mrs. Hayman's contractions were still noted as irregular; however, vaginal examination revealed her cervix was changing, and it was recorded at 2 centimeters, effacement at 80 percent, and the fetus at station -3. Fetal monitoring reflected a fetal heart tone in the 140's, but an abnormal pattern, with decreased variability, lack of acceleration, and persistent late decelerations. That heart rate and pattern persisted through delivery. Mrs. Hayman's labor continued to progress slowly, and at 9:20 a.m. vaginal examination revealed the cervix to be 3 centimeters, with effacement at 80 percent, and at 10:44 a.m. the cervix was noted to be 4 to 5 centimeters. At 10:55 a.m., labor was augmented with Pitocin, and thereafter progressed fairly normally. At 1:55 p.m., January 6, 1993, Shalyn was delivered vaginally. Upon delivery thick meconium stained fluid was noted, but none was present below the cords. Shalyn initially required intubation and bagging with 100 percent oxygen for a low heart rate and poor respiratory effort, but was extubated at approximately 10 to 15 minutes of age in the delivery room. Her Apgar scores were 4, 7 and 8 at one, five and ten minutes. 3/ Shalyn was noted to have the physical stigmata of Down's syndrome, which was later substantiated by chromosomal analysis, and was ultimately transferred to the neonatal intensive care unit (NICU) for further care and management. Following admission to the NICU, Shalyn failed to maintain appropriate respirations or oxygenation, and she was re- intubated and placed on ventilator support. Her hospital course was consistent with severe persistent pulmonary hypertension of the newborn, and she required extensive ventilator support. Cardiac disease was ruled out by echocardiogram. Shalyn's initial hematocrit was 57 with a platelet count of 43,000. The reason for this thrombocytopenia was unknown, although Down's syndrome or perinatal depression were considered as possibilities. On January 7, 1993, Shalyn developed symptomatic polycythemia and a partial exchange transfusion was done. The same day, Shalyn suffered cardiac arrest, which responded to epinephrine and Bicarb. On January 8, 1993, Shalyn was noted to have developed seizure activity, which was treated with Phenobarbital, Dilantin and intermittent lorazepam before the seizures were under control. An electroencephalogram demonstrated bilateral spiked discharges. In response to the seizure activity, a neonatal head ultrasound was taken on January 8, 1993, to rule out intraventricular hemorrhage. The ultrasound was entirely normal, with no evidence of hemorrhage into the ventricular system or the tissue immediately surrounding the ventricle. Shalyn was slowly weaned from ventilatory support and by January 11, 1993, was on an oxygen hood, and by January 14, 1993, was on room air. Physical examination on January 12, 1993, revealed Shalyn to be alert and active under the oxygen hood, her anterior and posterior fontanelle open and flat, not bulging, and neurologically to demonstrate good activity, but decreased tone. On January 15, 1993, Shalyn underwent a CT brain scan to rule out congenital malformation. That scan revealed the following: There is a large right sided intracerebral hematoma involving the occipital area with mild mass effect on the right lateral ventricle. There is a much smaller area of intracerebral hematoma anterior to the larger one in the high frontal parietal area and there is a tiny intracerebral hematoma in the high left frontal parietal region. There is also some hemorrhage in the body of the left lateral ventricle and the ventricular system shows mild dilatation but no midline shift. There is no extra-axial fluid collections. IMPRESSION: There are bilateral intracerebral hematomas but the primary and largest one is located in the right parietal occipital region and causing mild mass effect on the ventricular system. There is minimal hydrocephalus with no midline shift. There is some extension into the ventricular system with blood in the left lateral ventricle. A follow-up head ultrasound was administered on January 23, 1993. In contrast to the head ultrasound conducted on January 8, 1993, the January 23rd ultrasound clearly demonstrated "a dilated ventricle system with bilateral intraventricular hemorrhage with large right occipital parenchymal bleed, essentially unchanged from the previous CT scan" of January 15, 1993. On January 25, 1993, Shalyn underwent a second brain CT scan. The January 25th scan indicated the hemorrhage was now resolving and had decreased in size. In place of the resolving hemorrhage, a resultant encephalomalacia was diagnosed. Subsequent CT scans have confirmed bilateral damage in the form of porencephalic cystic areas in the right temporal parietal and occipital lobes. These areas are consistent with the resolution of an infarct and hemorrhage. The focal damage to Shalyn's brain, evident from the CT scans, is consistent with an injury caused by an intraventricular hemorrhage, but is not consistent with the global changes to the structures of the brain associated with asphyxia. Shalyn was discharged from St. Mary's on January 30, 1993, with evident neurologic impairment. Currently, Shalyn is microcephalic, cortically blind, and has increased tone and spasticity of all four limbs, with very limited motor development. In sum, neurological examination reveals a severe degree of both mental and motor impairment, that is permanent in nature. The cause and timing of Shalyn's injury In addressing the cause and timing of Shalyn's injury, it is first observed that Shalyn has been diagnosed with Trisomy 21, also known as Down's Syndrome. Down's Syndrome is a genetic condition, which often results in mental and physical impairment. In Shalyn's case, however, her neurological impairments are significantly different and more severe than one would normally expect in a child suffering only from Down's Syndrome. Consequently, it must be concluded that Down's Syndrome is not the cause of Shalyn's current impairments. Having rejected Down's Syndrome as the cause of Shalyn's injury, the only logical conclusion to be drawn from the proof is that the injury Shalyn suffered to her brain was occasioned by a large intracerebral hemorrhage, and not asphyxia. In so concluding, it is observed that the pattern of her brain damage is focal, as opposed to the global damage one would attribute to asphyxia. Moreover, the medical records do not evidence associated organ damage, which would normally be present if Shalyn had suffered acute hypoxia. Finally, while the delivery records clearly reflect an abnormal fetal heart rate from the onset of labor, no pattern developed that would reflect acute hypoxia or an asphyxial state during labor or delivery and, as heretofore noted, there was no objective evidence of brain damage consistent with asphyxia. Consequently, it is unlikely that Shalyn suffered a hypoxic episode during labor or delivery. Having resolved that the cause of Shalyn's brain injury, and the resultant permanent and substantial mental and physical impairment, was the intracerebral hemorrhage she suffered, it becomes necessary to address the timing and origin of that hemorrhage. As for the timing, the proof demonstrates that Shalyn's ultrasound of January 8, 1993, demonstrated a normal ventricular system and no evidence of hemorrhage; however, the CT brain scan of January 15, 1993, did reveal the presence of such hemorrhage. Therefore, based on the medical evidence of record, it is reasonable to conclude that Shalyn experienced the disabling intracerebral hemorrhage sometime between January 8, 1993, and January 15, 1993, or, stated differently, after labor, delivery and resuscitation in the immediate post-delivery period. As for the cause of the hemorrhage, the proof demonstrates that, shortly after birth, Shalyn developed polycythemia, and that polycythemia is associated with hemorrhages, including hemorrhagic stroke. 4/ Given the proof, the opinion of Michael Duchowny, M.D., a board certified pediatric neurologist associated with Miami Children's Hospital, that Shalyn's hemorrhage most likely was associated with her polycythemia and was not related to any event during the birth process, is credited.
