vs. ) Case No. 00-1007N
Intervenors. )
Pursuant to notice, the Division of Administrative Hearings, by Administrative Law Judge William J. Kendrick, held a final hearing in the above-styled case on September 27, 2000, by video teleconference, with sites in Tallahassee and Fort Lauderdale, Florida.
For Petitioner: Jesse S. Faerber, Esquire
Stacie L. Cohen, Esquire Fenster and Faerber, P.A
Graham, Moody & Sox, P.A.
George E. Bunnell, Esquire
Bunnell, Woulfe, Kirschbaum, Keller, Cohen & McIntyre, P.A.
Ronald A. FitzGerald, Esquire Conrad & Scherer
At issue in the proceeding is whether Ava Katherine Nagy, a minor, suffered an injury for which compensation should be awarded under the Florida Birth-Related Neurological Injury Compensation Plan.
On March 3, 2000, Thomas Nagy and Dawn Nagy, as parents and natural guardians of Ava Katherine Nagy (Ava), a deceased minor, filed a petition with the Division of Administrative Hearings (hereinafter referred to as "DOAH") for a determination as to whether Ava suffered an injury that is compensable under the Florida Birth-Related Neurological Injury Compensation Plan (hereinafter referred to as the "Plan"). According to the petition, Petitioners were of the view that Ava's injury was not
compensable under the Plan; however, during a pre-suit exchange of information, counsel for the physician who provided obstetrical services at birth claimed that the injury was compensable under the Plan. Consequently, consistent with the provisions of Section 766.304, Florida Statutes"; Petitioners filed their petition to resolve the issue.
DOAH served the Florida Birth-Related Neurological Injury Compensation Association (hereinafter referred to as "NICA") with a copy of the claim on March 6, 2000. NICA reviewed the claim, and on March 23, 2000, gave notice that it had "determined that such claim is a 'birth-related neurological injury' within the meaning of Section 766.302(2), Florida Statutes"; however, since Petitioners harbored a contrary opinion, NICA requested that "an order [be entered] setting a hearing in this cause on the issue of the compensability of this claim." Such a hearing was ultimately scheduled for September 27, 2000. In the interim, Susan Davila, M.D., and South Broward Hospital District were accorded leave to intervene.
At hearing, the parties stipulated to the factual matters set forth in paragraphs 1 and 2 of the Findings of Fact.
Petitioners (Thomas Nagy and Dawn Nagy) testified on their own behalf and Petitioners' Exhibits 1-5 were received into evidence. No further witnesses were called; however, Respondent's Exhibits
1 and 2 were received into evidence.
The transcript of the hearing was filed October 10, 2000, and the parties were accorded 10 days from that date to file proposed final orders or memorandum of law. The parties' post- hearing submittals have been duly considered.
Thomas Nagy and Dawn Nagy are the parents and natural guardians of Ava Katherine Nagy, a deceased minor. Ava was born a live infant on November 20, 1998, at South Broward Hospital District, d/b/a Memorial Regional Hospital, a hospital located in Broward County, Florida, and her birth weight was in excess of 2,500 grams.
The physician providing obstetrical services during the birth of Ava was Susan Davila, M.D., who was at all times material hereto a "participating physician" in the Florida Birth- Related Neurological Injury Compensation Plan, as defined by Section 766.302(2), Florida Statutes.
Coverage under the Plan
Pertinent to this case, coverage is afforded under the Plan, when the proof demonstrates, more likely than not, that the infant suffered an "injury to the brain . . . caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate post-delivery period in a hospital, which renders the infant permanently and
substantially mentally and physically impaired."1 Here, NICA and the Intervenors are of the view that Ava suffered a "birth- related neurological injury," as defined by the Plan, and request that the claim be accepted as compensable. Petitioners, however, are of the view that Ava did not suffer a "birth-related neurological injury" and request that the claim be rejected so they may pursue their civil remedies.
Ava's birth and subsequent development
Mrs. Nagy presented at Memorial Regional Hospital at approximately 6:00 a.m., November 20, 1998, for induction of labor. Apart from being slightly post-date (with an EDC of November 16, 1998), Mrs. Nagy's prenatal course had been uncomplicated, and on admission fetal heart rate was noted within normal limits (at 140-150 beats per minute) and positive fetal movements were reported.
Mrs. Nagy's labor progress was slow, but steady, and external fetal monitoring reflected a normal fetal heart rate throughout the course of labor. At about 5:30 p.m., Mrs. Nagy began to push and at 8:00 p.m., with arrest of descent noted, Dr. Davila attempted a vacuum assisted delivery. According to the records, two pulls were made without success, and Mrs. Nagy was transferred to the operating room for delivery by cesarean section.
Ava was delivered by cesarean section at 8:43 p.m. On delivery, Ava was noted to be pale, with poor perfusion, and her heart sounds were noted as distant. Ava was warmed, dried, and stimulated; suctioned by catheter; and offered free-flowing oxygen by mask. Apgar scores were noted as 6 at one minute and 7 at five minutes.
The Apgar scores assigned to Ava are a numerical expression of the condition of a newborn infant, and reflect the sum points gained on assessment of heart rate, respiratory effort, muscle tone, reflex irritability, and color, with each category being assigned a score ranging from the lowest score of
0 through a maximum score of 2. As noted, at one minute, Ava's Apgar score totaled 6, with heart rate being graded at 2, and respiratory effort, muscle tone, reflex irritability, and color being graded at 1 each. At five minutes, Ava's Apgar score totaled 7, with heart rate and respiratory effort being graded at
2 each, and muscle tone, reflex irritability, and color being graded at 1 each.
Ava was transferred to the neonatal intensive care unit (NICU), where she was admitted at 8:52 p.m., and placed in a preheated isolate. Assessment on admission evidenced a temperature of 975, pulse of 140, respiratory rate of 64, and blood pressure of 43/23/33. Abnormalities noted included a bruised scalp; boggy occipital area, with possible
cephalohematoma ("a subperiosteal hemorrhage limited to the surface of one cranial bone, a usually benign condition seen frequently in the newborn as a result of bone trauma");2 pink, cyanotic skin color, as well as pale mouth and lips; and distant heart sounds. Preliminary diagnosis was hypovolemia ("abnormally decreased volume of circulating fluid (plasma) in the body").3 "UVC were placed by Dr. [Mesfin] Afework, the [neonatalogist],
. . . admission labs obtained, [and] x-ray called."
Over the next half-hour, Ava's blood pressure dropped and she was started on saline bolus and sodium bicarbonate. When she failed to improve, Ava was started on albumin and dopamine drip. Notwithstanding, at 10:45 p.m., Ava was in respiratory failure, and she was intubated and placed on a respiratory.
Dr. Afework's physical examination at approximately 10:30 p.m., noted a temperature of 925, pulse rate of 110, respiratory rate of 64, and blood pressure of 43/23/33. Abnormalities noted were a pale infant, with poor perfusion; a boggy occipital area, with suspected bleed; distant heart sounds; and poor peripheral pulses. Neurological assessment revealed a limp infant, with reduced movement. Dr. Afework's diagnosis included hypotension/shock, hypovolemia, and subgaleal bleed (bleeding between the skull and the scalp). His plan of treatment included volume expansion, correction of her acidotic state, and transfusion with packed red blood cells. Subsequent
laboratory results revealed a low hematocrit, consistent with internal bleeding.
Ava was not responsive to volume replacement, sodium bicarbonate for acidosis, or dopamine to maintain her blood pressure; she continued to deteriorate and bleed internally; and by 3:00 a.m., November 21, 1998, she was in cardiogenic shock. At the time, Dr. Afework noted a diagnosis of "persistent acidosis/cardiogenic shock" and that trial of ECMO
(Extracorporeal Membrane Oxygenation) was the only chance, albeit a slim chance, she had for survival.
Ava was placed on ECMO at approximately 4:50 a.m.
Unfortunately, due to an anticoagulant used to prevent clotting during the procedure, she began to bleed from her mouth, and bleeding increased under her scalp and into her neck.
Due to the active bleeding and persistent acidosis dispute sodium bicarbonate drip, discontinuation of ECMO was recommended. Moreover, due to Ava's poor chance of recovery, her physician also recommended that conventional therapy (such as mechanical ventilation) not be resumed.
When the parents were informed that Ava had not responded to ECMO treatment, and that she had a terminal condition ("caused by injury, disease, or illness from which, to a reasonable degree of medical certainty, there is no reasonable probability of recovery and which may be expected to cause
death") they consented to withdrawing and withholding life prolonging procedures. Parental consents were signed at 10:05 a.m., ECMO was clamped at 10:07 a.m., and Ava was pronounced dead at 10:45 a.m., November 21, 1998.4
The cause and timing of the injury which led to Ava's neurologic insult and death
Here, it is not subject to serious debate that, at delivery, Ava received an injury, a subgaleal hemorrhage, caused by the traumatic application of the vacuum extractor and that the hemorrhage continued, and became more critical, resulting in the pathophysiology of events (including hypovolemia, hypoprofusion, hypotension, and the clinical appearance of cardiogenic shock) which followed. Dr. Robert F. Cullen, Jr., a pediatric neurologist, whose opinions were offered on behalf of Petitioners, described the pathophysiology of events which ensued, including brain injury, as follows:
Q. So it was the initial trauma which caused the bleeding, which then caused the other sequela . . . [as well as] oxygen deprivation to the brain, correct?
A. It was trauma to the skull that produced anemia . . . [a consequence of hypovolema], hypotension, hypoprofusion, ischemia, cardiogenic shock, ultimately deprivation of oxygen to the brain and death. That's the sequence of events that continues to occur over the 14 hours after the child's birth.
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Q. The metabolic acidosis in this case . . . would be evidence of an injury to the brain, correct, sir?
* * *
A. I think that the acidosis and the progressively developing base excess would be indicative of brain injury and systemic injury to multiple tissues.
Q. Including the brain, sir?
A. Including the brain but that was progressive throughout the rest of the night and the following morning.
Q. You can't tell at what time that occurred, can you, sir?
A. I can tell you at midnight it [pH] was
6.83 so by that time there was certainly injury.
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[Q.] Do you have an opinion as to whether this baby at any time suffered brain damage and, if so, when?
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A. I think that this baby was suffering brain damage during this 14-hour spectrum. I think it became more apparent after a few hours when the baby's blood pressure -- and we're in a picture of cardiogenic shock, but I can't give you the minute at which it occurred, no. It's a sequence of events that continue to compound themselves.
Q. So when I asked you when, that's generally the best you can do with the information that you have? You can't actually pinpoint it?
A. I can't give you a time, no.
Q. It was an ongoing process in your opinion.
A. It was an ongoing process that became progressively worse, yes.
* * *
[With regard to the significance of Ava's neurologic insult], this child did not have permanent and substantial mental impairment within the hour of delivery, and that permanent and substantial mental and physical impairment developed over the ensuing hours as a result of the hemorrhage in the subgaleal space and the other pathophysiological events that occurred.
Q. You agree that there was permanent physical and mental impairment but it wasn't within the first hour post-delivery; is that what your testimony is?
* * *
A. I've said yes because the baby died as a result of this injury so that's as permanent as you can get.
What I'm saying is that there's an ongoing sequence of events that produces a point of no return. That is not within the first hour, even though there may be some cellular injury occurring at that time, and it really doesn't become manifest for a number of hours. Can I give you a fixed time during that 14 hours? No.
Dr. Michael Duchowny, also a pediatric neurologist, whose opinions were offered on behalf of NICA, agreed with
Dr. Cullen's observations as to the cause, timing, and nature of Ava's injury, as well as the pathophysiology of the events that ensued. As Dr. Duchowny observed:
. . . this baby's demise was a direct result of a sequence that began intrapartum and that was related to the vacuum extraction.
Specifically that was related to [a subgaleal] hemorrhage and then the subsequent complications of hemorrhage [hypovolemia, hypotension, and hypoprofusion] which led to brain damage [most likely hypoxic or ischemic in nature], systemic collapse, and death.
Dr. Cullen's and Dr. Duchowny's opinions concerning the cause, timing, and nature of Ava's injury, as well as their opinions regarding the nature of the rapidly progressive catastrophe that ensued, are grossly consistent with the record, are founded on a logical premise, and are accepted as credible and persuasive.
Given the record, it may be resolved that Ava received a mechanical injury (a subgaleal hemorrhage, resulting from the traumatic application of the vacuum extractor) during the course of delivery. The record further reveals that the hemorrhage continued unabated, resulting in hypovolemia, hypotension, hypoprofusion, ischemia, cardiogenic shock, deprivation of oxygen to the brain, systemic collapse, and death. Finally, the record reveals that, while the effects of the hemorrhage may not have produced a significant brain injury during labor or resuscitation in the immediate post-delivery period, brain damage was progressive and became evident at least by midnight, if not by 10:30 p.m., and progressively worsened until a point in time
(described by Dr. Cullen as "a point of no return"), prior to Ava's death or her removal from life support, when the injury was so profound that the resulting impairment (mental and physical) could reasonably be described as permanent and substantial.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the parties to, and the subject matter of, these proceedings. Section 766.301, et seq., Florida Statutes.
The Florida Birth-Related Neurological Injury Compensation Plan was established by the Legislature "for the purpose of providing compensation, irrespective of fault, for birth-related neurological injury claims" relating to births occurring on or after January 1, 1989. Section 766.303(1), Florida Statutes.
The injured "infant, his personal representative, parents, dependents, and next of kin," may seek compensation under the Plan by filing a claim for compensation with the Division of Administrative Hearings. Sections 766.302(3), 766.303(2), 766.305(1), and 766.313, Florida Statutes. The Florida Birth-Related Neurological Injury Compensation Association, which administers the Plan, has "45 days from the date of service of a complete claim . . . in which to file a response to the petition and to submit relevant written information relating to the issue of whether the injury is a
birth-related neurological injury." Section 766.305(3), Florida Statutes.
If NICA determines that the injury alleged in a claim is a compensable birth-related neurological injury, it may award compensation to the claimant, provided that the award is approved by the administrative law judge to whom the claim has been assigned. Section 766.305(6), Florida Statutes. If, however, the parents dispute the issue of coverage, as they have in the instant case, the dispute must be resolved by the assigned administrative law judge in accordance with the provisions of Chapter 120, Florida Statutes. Sections 766.304, 766.307, 766.309, and 766.31, Florida Statutes.
In discharging this responsibility, the administrative law judge must make the following determination based upon the available evidence:
Whether the injury claimed is a birth- related neurological injury. If the claimant has demonstrated, to the satisfaction of the administrative law judge, that the infant has sustained a brain or spinal cord injury caused by oxygen deprivation or mechanical injury and that the infant was thereby rendered permanently and substantially mentally and physically impaired, a rebuttable presumption shall arise that the injury is a birth-related neurological injury as defined in s. 766.303(2).
Whether obstetrical services were delivered by a participating physician in the course of labor, delivery, or resuscitation in the immediate post-delivery period in a
hospital; or by a certified nurse midwife in a teaching hospital supervised by a participating physician in the course of labor, delivery, or resuscitation in the immediate post-delivery period in a hospital.
Section 766.309(1), Florida Statutes. An award may be sustained only if the administrative law judge concludes that the "infant has sustained a birth-related neurological injury and that obstetrical services were delivered by a participating physician at birth." Section 766.31(1), Florida Statutes.
Pertinent to this case, "birth-related neurological injury" is defined by Section 766.302(2), Florida Statutes, to mean:
. . . injury to the brain or spinal cord of a live infant weighing at least 2,500 grams at birth caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate post-delivery period in a hospital, which renders the infant permanently and substantially mentally and physically impaired. This definition shall apply to live births only and shall not include disability or death caused by genetic or congenital abnormality.
As the proponents, the burden rested on NICA and the Intervenors to demonstrate that the claim was compensable under the Plan. Section 766.309(1)(a), Florida Statutes. See also
Balino v. Department of Health and Rehabilitative Services,
348 So. 2d 349, 350 (Fla. 1st DCA 1977), ("[T]he burden of proof,
apart from statute, is on the party asserting the affirmative issue before an administrative tribunal").
Here, there is no serious debate as to nature, cause, or timing of Ava's injury or the events which ensued. Rather, what is disputed is the appropriate reading that should be accorded the Plan definition of "birth-related neurological injury."
With regard to that definition, Petitioners suggest
that:
[a] proper statutory construction in the present case mandates the conclusion that the NICA provisions do not apply to the death of Ava . . . . The statute plainly requires an injury to the brain or a spinal cord of an infant occurring during labor, delivery or resuscitation in the immediate post delivery period. The injury sustained at birth was not an injury to the brain.
(Petitioners' proposed final order, at page 10). Essentially, Petitioners argue that since Ava's brain injury did not occur until later in the post-delivery course, as opposed to during delivery or resuscitation, her injury was not a "birth-related neurological injury" as defined by the Plan.
In comparison, NICA is of the view that:
. . . The substance of section 766.302(2) does not mandate that the brain, as an organ, suffer a direct injury during labor, delivery or resuscitation in the immediate post- delivery period. Rather, the pivotal requirement is that the injury which causes the brain damage occurs during labor,
delivery, or resuscitation in the immediate post-delivery period. It is appreciated, that an actual injury to the brain may not manifest itself until hours or even days after labor. With this in mind, the statute must be applied to remedy those injuries which clearly occur during labor and directly, without interruption, lead to brain damage. Such injuries must be deemed compensable if the statute is to fulfill its legislative purpose.
(NICA's proposed final order, at page 6). Intervenors' perspective is similarly stated, at pages 9 and 10 of their proposed final order.
Given the plain and ordinary meaning of the language chosen by the legislature to define "birth-related neurological injury," it must be resolved that, as advocated by NICA and the Intervenors, it is the mechanical injury and not the ultimate consequences of that injury (i.e.: "an injury to the brain . . . which renders the infant permanently and substantially mentally and physically impaired"), which must occur during labor, delivery, or resuscitation for the claim to be compensable. Consequently, Petitioners' reading of the statute must be rejected. See Southeastern Fisheries Association, Inc. v.
Department of Natural Resources, 453 So. 2d 1351 (Fla. 1984)(Where the legislature has not defined the words used in a phrase, the language should usually be given its plain and ordinary meaning).
Consequently, since Ava suffered an "injury to the brain . . . caused by . . . mechanical injury occurring in the course of . . . delivery . . . which render[ed] [her] permanently and substantially mentally and physically impaired," it necessarily follows that Ava suffered a "birth-related neurological injury," within the meaning of Section 766.302(2), Florida Statutes. Moreover, since the record also demonstrates that the physician who provided obstetrical services at birth was a "participating physician," as that term is defined by Section 766.302(7), Florida Statutes, the claim is compensable under the Plan. Sections 766.302(2), 766.309(1), and 766.31(1), Florida Statutes.5
Where, as here, the administrative law judge determines that "the infant has sustained a birth-related neurological injury and that obstetrical services were delivered by a participating physician at birth," the administrative law judge is required to make a determination as to how much compensation, if any, is to be awarded. Section 766.31(1), Florida Statutes. In this case, the issues of compensability and the amount of compensation to be awarded were bifurcated. Accordingly, absent agreement by the parties, a further hearing will be necessary to resolve any existing dispute regarding "actual expenses," the amount and manner of payment of "an award to the parents," and
the "reasonable expenses incurred in connection with the filing of the claim." Section 766.31(1), Florida Statutes.
Where, as here, the administrative law judge determines that a claim qualifies for coverage under the Plan, he is required to enter an order to such effect and cause a copy of such order to "be sent immediately by registered or certified mail to each person served with a copy of the petition under
Tallahassee, Leon County, Florida.
WILLIAM J. KENDRICK
1/ Coverage is also afforded by the Plan when the infant suffered an "injury to the . . . spinal cord . . . caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate post-delivery period in a hospital, which renders the infant permanently and substantially mentally and physically impaired." Here, there was no spinal cord injury, and that alternative need not be further addressed.
4/ An autopsy was not performed and no CT scans or MRI scans were performed before Ava's death because she was too ill to have them. A cranial ultrasound performed at 2:38 a.m., November 21, 1998 (approximately 6 hours after birth) was normal, with no evidence of intra or extra ventricular hemorrhage; however, that study is not particularly useful in resolving any issue of brain injury in this case since it takes 12 to 18 hours for brain edema to develop, and the infant died within 14 hours of her birth.
5/ That such birth-related neurological injury resulted in post- delivery death does not alter the conclusion that the subject
claim is compensable under the Plan. University of Miami v. Klein, 603 So. 2d 651 (Fla. 3d DCA 1992).
Jesse S. Faerber, Esquire Fenster and Faerber, P.A. Suite 307
Richard Sox, Esquire Graham, Moody & Sox, P.A.
George E. Bunnell, Esquire
Bunnell, Woulfe, Kirschbaum, Keller, Cohen & McIntyre, P.A.
Ronald A. FitzGerald, Esquire Conrad & Scherer
Injury Compensation Association Post Office Box 14567 Tallahassee, Florida 32317-4567
Susan Davila, M.D. 1150 North 35th Avenue
Ms. Charlene Willoughby
Daniel Y. Sumner, General Counsel Department of Insurance
A party who is adversely affected by this final order is entitled to judicial review pursuant to Sections 120.68 and 766.311, Florida Statutes. Review proceedings are governed by the Florida Rules of Appellate Procedure. Such proceedings are commenced by filing one copy of a Notice of Appeal with the Agency Clerk of the Division of Administrative Hearings and a second copy, accompanied by filing fees prescribed by law, with the appropriate District Court of Appeal. See Section 120.68(2), Florida Statutes, and Florida Birth-Related Neurological Injury Compensation Association v. Carreras, 598 So. 2d 299 (Fla. 1st DCA 1992). The Notice of Appeal must be filed within 30 days of rendition of the order to be reviewed.
