STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

CHERYL and RICHARD LUTEN, )

individually, and as parents and ) natural guardians of KALLIE )

MORGAN LUTEN, a minor. )

)

Petitioners, )

)

vs. ) CASE NO. 95-3708N

) FLORIDA BIRTH-RELATED NEUROLOGICAL ) INJURY COMPENSATION ASSOCIATION, )

)

Respondent. )

)

FINAL ORDER

Pursuant to notice, the Division of Administrative Hearings, by its duly designated Hearing Officer, William J. Kendrick, held a formal hearing in the above-styled case on May 14, 1996, in Tallahassee, Florida.

APPEARANCES

For Petitioner: Kristin Adamson, Esquire

Novey, Mendelson and Adamson 851 East Park Avenue Tallahassee, Florida 32301

For Respondent: W. Douglas Moody, Jr., Esquire

BATEMAN GRAHAM, P.A.

300 East Park Avenue Tallahassee, Florida 32301

STATEMENT OF THE ISSUE

At issue in this proceeding is whether Kallie Morgan Luten, a minor, suffered an injury for which compensation should be awarded under the Florida Birth-Related Neurological Injury Compensation Plan.

PRELIMINARY STATEMENT

On July 25, 1995, Cheryl and Richard Luten, individually, and as parents and natural guardians of Kallie Morgan Luten, a minor, filed a petition (claim) with the Division of Administrative Hearings (hereinafter referred to as "DOAH") for compensation under the Florida Birth-Related Neurological Injury Compensation Plan (hereinafter referred to as the "Plan").

DOAH served the Florida Birth-Related Neurological Injury Compensation Association (hereinafter referred to as "NICA") with a copy of the claim on July 26, 1995. NICA reviewed the claim and, following an extension of time to respond to the claim, gave notice that it had "determined that such claim is not a 'birth related neurological injury' within the meaning of Section 766.302(2), Florida Statutes" and requested that the Hearing Officer "enter an order setting a hearing in this cause on the issue of the compensability of this claim." Such a hearing was held on May 14, 1996.

At hearing, petitioners called, as witnesses, Jana Bures- Forsthoefel, M.D., Ricardo Ayala, M.D., Gary Wayne Carter, M.D., Cheryl Luten, and Richard Luten. Petitioners' exhibit 1 was received into evidence. Respondent called Lance Edward Wyele, M.D., as a witness, and its exhibit 1 (the deposition of Dr.

Charles Kalstone) was received into evidence. The medical records that were filed with the claim, and tabbed 1 through 12, were received into evidence as joint exhibit 1.

The transcript of the hearing was filed June 25, 1996 and the parties were accorded thirty days from that date to file proposed final orders. Consequently, the parties waived the requirement that a final order be rendered within thirty days after the transcript is filed. Rule 60Q-2.031, Florida Administrative Code. Petitioners elected to file such a proposal, and the proposed findings of fact contained therein are addressed in the appendix of this final order.

FINDINGS OF FACT

Fundamental Findings

1. Cheryl and Richard Luten are the parents and natural guardians of Kallie Morgan Luten (Kallie), a minor. Kallie was born a live infant on June 15, 1993, at Tallahassee Memorial Regional Medical Center (Tallahassee Memorial), a hospital located in Tallahassee, Leon County, Florida, and her birth weight was in excess of 2,500 grams.

   
   

2. The physician providing obstetrical services during the birth of Kallie was Jana M. Bures-Forsthoefel, 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.

   
   

3. Here, the proof is uncontroverted that Kallie suffered an injury to her brain caused by oxygen deprivation, secondary to a fetomaternal transfusion, also referred to as a fetal-maternal transfusion or hemorrhage in these proceedings (a transplacental passage (loss) of fetal blood into the circulation of the mother), which rendered her permanently and substantially mentally and physically impaired. What is at issue is the timing of such event or, stated differently, whether such event and Kallie's ensuing injury occurred during "the course of labor, delivery, or resuscitation in the immediate post-delivery period in a hospital," as advocated by petitioners, or whether the fetomaternal transfusion and injury predated such events, as advocated by respondent. 1/

   Mrs. Luten's Antepartum Course and Kallie's Delivery

   
   

4. At the time of Kallie's conception, Mrs. Luten was 23 years of age, and without prior pregnancy. Her estimated date of confinement was established as July 10, 1993, and the progress of her pregnancy was essentially normal until June 14, 1993.

   
   

5. On June 14, 1993, with Kallie at 36 weeks gestation, Mrs. Luten reported for work, as usual, by 8:30 A.M. At or about 10:00 A.M. Mrs. Luten experienced a sharp pain in her left side, and approximately thirty minutes later began to experience irregular contractions. Around 1:00 P.M., Mrs. Luten began to notice decreased fetal movement.

   
   

6. Although "uncomfortable throughout the day," Mrs. Luten remained at her place of employment until 4:30 P.M., when she returned to her home. Following her husband's arrival, at a time not apparent from the record, the Lutens telephoned the offices of her obstetrician, Dr. Jana Bures-Forsthoefel (Dr. Forsthoefel). 2/ Dr. Forsthoefel returned the call in the early evening, at which time she was advised of the pain Mrs. Luten had been experiencing in the "left upper quadrant," the decreased fetal movement, and the contractions she had experienced during the course of the day. As a consequence, Dr. Forsthoefel asked Mrs. Luten to come to the hospital for further monitoring.

   
   

7. Mrs. Luten was admitted to the antenatal testing unit at Tallahassee Memorial Regional Medical Center at approximately 7:30 P.M. Physical examination revealed the cervix to be long, closed, and thick and the fetus out of the pelvis with vertex presentation. In sum, a non-labor cervix. The membranes were intact, and there was no evidence of amniotic fluid.

8. At approximately 7:45 P.M., Mrs. Luten was placed on an external fetal monitor. 3/ At the time, fetal heart tone was noted to be between 130 and 145 beats per minute, a normal range; however, the heart rate pattern was nonreactive (without accelerations), an abnormal circumstance. Notably, such nonreactive pattern was not reassuring for fetal well-being, could reflect fetal compromise, and persisted throughout the evening.

   
   

9. At approximately 8:30 P.M., Mrs. Luten evidenced a large contraction, with a late deceleration of the fetal heart rate to

   110 beats per minute for 80 seconds. Mrs. Luten was repositioned to her side, with the recovery of fetal heart rate to base line. Further uterine irritability was noted, but without further decelerations. An IV was started for dehydration, and Mrs. Luten's pain in the left upper quadrant was noted to resolve within an hour of her admission.

   
   

10. Because of the late deceleration and nonreactive pattern, Mrs. Luten was ordered to remain at the hospital overnight for observation and long term monitoring. At the time, the physician's plan was to discharge Mrs. Luten in the morning if the baby did well during the night and, if not, to proceed with further studies. Among the possibilities was an amniocentesis to assess the maturity of the infant's lungs, with delivery if stable.

    
    

11. At approximately 9:40 P.M., Mrs. Luten had another spontaneous contraction with a late deceleration to 100 beats per minute lasting 140 seconds. Mrs. Luten was again repositioned. At approximately 10:00 P.M. a deceleration unassociated with a contraction was noted to 95 beats per minute and lasting 120 seconds. Thereafter, monitoring evidenced continued uterine irritability and small contractions without deceleration. There were, however, no regular contractions or other objective evidence of labor, and there was not such evidence at any time during the course of monitoring.

    
    

12. Mrs. Luten was transferred from the antenatal testing unit to the labor and delivery suite later in the evening, and at approximately 1:00 A.M., June 15, 1993, she was given Nembutal for sleep. Approximately 30 minutes later the fetal heart tones were noted to have diminished to 110 to 120 beats per minute, a normal reaction following the Nembutal, and no unusual activity was noted until approximately 2:40 A.M. At that time, a spontaneous contraction was noted, with a late deceleration which recovered. A few minutes later the fetal heart rate began to slowly drop, unassociated with any uterine activity, and by approximately 2:55 A.M. the fetal heart rate was at 80 to 90 beats per minute. The drop in fetal heart rate was unresolved by

    positioning, hydration and oxygenation, and at approximately 3:10

    A.M. Dr. Forsthoefel was called.

    
    

13. Dr. Forsthoefel arrived at the hospital at approximately 3:20 A.M., and a fetal heart rate of 80 to 90 beats per minute was confirmed. Fetal activity was noted, and Dr. Forsthoefel elected to do an emergency cesarean section for prolonged bradycardia.

    
    

14. Mrs. Luten was taken to the operating room, and a low transverse cesarean section was performed. On entry into the uterus, there was no cord problem identified and the amniotic fluid was clear. Kallie was delivered at 3:36 A.M. and handed off to the attending neonatologist (Dr. Gary Cater) after cord clamping. Cord blood was obtained which appeared thin and watery. There was no blood in the uterine cavity, and examination of the placenta showed it to be posterior and intact, with no evidence of abruption. The placenta was manually removed, with no blood clot noted posteriorly. There was no abnormal bleeding noted at the time of delivery, and no obvious cause of fetal distress could be identified. The cervix was noted to be long, closed and thick, as it had been on Mrs. Luten's admission to the hospital.

    
    

15. At delivery, Kallie was pale, flaccid and without spontaneous movement, and her heart rate was around 30 or 40 beats per minute. Demonstrated Apgars were 1 at one minute, 2 at five minutes, 2 at ten minutes, and 3 at fifteen minutes.

    
    

16. Kallie was promptly intubated and bagged with 100 percent oxygen. Because of her pallor and lack of perfusion, an umbilical venous catheter was placed and epinephrine and Plasmanate (a volume expander to increase the blood volume of the infant so there is adequate volume to circulate through the body to transport oxygen) was administered. By about 5 minutes of age, Kallie's heart rate was greater than 100, and she was taking an occasional gasp.

    
    

17. At 15 to 20 minutes of life, Kallie was transported to the neonatal intensive care unit (NICU) where she was placed on a ventilator, IVs were placed, and a transfusion started. Upon transfusion, she started to improve, both by appearance and by activity; however, a few hours later her condition suddenly deteriorated and required substantially increased ventilator settings. Over the next couple of days, Kallie's respiratory status gradually improved, and she was ultimately weaned off the ventilator and extubated on June 18, 1993.

    
    

18. Kallie had two crainal ultrasounds, one on June 15, 1993, and the other on June 21, 1993, which were normal. An EEG

    of November 5, 1993, evidenced "[n]o significant abnormalities for age"; however, an MRI brain scan of the same date revealed:

    
    

    There are prominent CSF spaces bilaterally including the region of the inner hemispheric fissures. White matter maturation appears normal for age. The lateral ventricles are slightly prominent. No evidence of mass effect or intracranial hemorrhage. The

    brain stem appears normal.

    
    

    IMPRESSION: Prominent CSF spaces bilate- rally. Mild prominence to the lateral ventricles.

    
    

    At approximately 6 months of age, Kallie developed infantile spasms/seizures, which were confirmed by EEG of January 6, 1994.

    
    

19. The proof is uncontroverted, as evidenced by the consensus of opinion of the physicians who testified and the objective evidence accorded by testing of the maternal blood following Kallie's delivery, that the injury to Kallie's brain, evidenced by the MRI brain scan of November 5, 1993, was occasioned by an acute anoxic event, secondary to a significant fetal to maternal bleed (a fetomaternal transfusion). 4/ The proof is likewise uncontroverted that the injury to Kallie's brain has rendered her permanently and substantially mentally and physically impaired. 5/ Consequently, resolution of this claim resolves itself to whether the proof supports the conclusion that the fetomaternal transfusion, and Kallie's consequent injury, occurred in the course of labor, delivery, or resuscitation in the immediate post-delivery period, as advocated by petitioners, or prior to such events, as advocated by respondent. 6/

    The Timing of Kallie's Insult

    
    

20. In resolving the issue relating to the timing of Kallie's insult, it is first observed that the proof is compelling that upon admission to Tallahassee Memorial on June 14, 1993, Mrs. Luten was not in labor, and did not at any time thereafter go into labor, as that term is commonly understood and as that term is used in the Plan. Notably, when Mrs. Luten was physically examined on admission the cervix was long, closed and thick (a non-labor cervix) and the fetus was out of the pelvis. Moreover, following admission Mrs. Luten was continuously monitored until the cesarian section, without evidence of regular contractions. Finally, upon delivery the cervix was examined and noted as still long, closed and thick. Such objective findings are inconsistent with labor, and the absence of labor was clearly noted by Mrs. Luten's attending physician. 7/

21. While not in labor, such observation does not compel the conclusion that Kallie's injury is not covered by the Plan. Indeed, apart from injuries "occurring in the course of labor," the Plan also covers injuries "occuring in the course of . . . delivery or resuscitation in the immediate post-delivery period." Consequently, if it can be shown that the fetomaternal transfusion occurred during the later period, Kallie's injury would be covered by the Plan. 8/

    
    

22. In further resolving the issues relating to the timing of Kallie's insult, the records in this case have been painstakingly reviewed on numerous occasions, including the observations and opinions of the physician experts offered on behalf of petitioners and those offered on behalf of respondent. Having closely evaluated the physicians' observations and opinions, it is concluded that the opinions of the physicians offered by respondent, that Kallie's insult most likely predated her mother's admission to the hospital, are most consistent with the objective proof of record, and therefore most credible. The opinions offered on behalf of petitioners are less than persuasive given such considerations, and are therefore rejected in large measure. 9/

    
    

23. In concluding that the proof demonstrates, more likely than not, that Kallie's injury predated her mother's admission on June 14, 1993, it is first observed that upon admission Kallie's presentation was consistent with fetal compromise. In this regard, the proof demonstrates that decreased fetal movement had been observed prior to admission, and that upon admission Kallie's heart rate pattern was nonreactive, without accelerations, and that pattern continued until delivery. An absence of accelerations, especially over an extended period as experienced in the instant case, is an ominous sign for fetal well being, and when viewed with the decreased fetal movement and decelerations evidenced during the course of admission is consistent with prior hypoxic insult. 10/

    
    

24. The absence of accelerations of fetal heart rate during the term of Mrs. Luten's admission is also objective evidence that the fetal maternal transfusion/hemorrhage occurred prior to admission. In this regard, it is noted that the initial reaction of the fetus to hemorrhage or acute blood loss is an acceleration in fetal heart rate, which was totally absent during the course of admission in this case. 11/

    
    

25. Further objective evidence of fetal insult prior to admission is the absence of any apparent cause, at delivery, to explain the ominous character of Kallie's presentation upon her mother's admission except acute fetomaternal hemorrhage. In this

    regard, it is noted that upon delivery the amniotic fluid was clear, no blood was observed in the uterine cavity, the placenta was intact and without blood clot and, despite scrutiny, the physician could not identify any obvious sign to account for Kallie's fetal distress. Subsequently, Kallie was noted to have suffered a fetomaternal transfusion, which unquestionably accounted for her hypoxic brain injury. Such is the only identified event that could reasonably account for the character of Kallie's presentation upon her mother's admission to the hospital.

    
    

26. Finally, proof was offered, through the opinions of Lance Wyele, M.D. neonatologist, that Kallie's clinical course was consistent with that of an infant beyond an acute injury phase. 12/ In that regard, Dr. Wyele observed that following delivery, the damaged organs were not demonstrating physiologic and pathophysiologic findings that one would see in the acute post-injury period, but were showing a much later pattern. Moreover, he observed that certain patterns one would expect to note following an acute insult were absent. Among the sequelae absent were hyper-alertness with weakness, as well as seizures in the initial 12 to 24 hours following delivery, and the absence of any evidence of cerebral edema within 24 to 72 hours of delivery. Consequently, Dr. Wyele opined that the fetomaternal transfusion, and Kallie's substantial brain injury, occurred at least 48 hours prior to delivery, and did not coincide with the fetal bradycardia which precipitated her delivery. Dr. Wyele's observations and opinions are consistent with the objective proof of record, are credible, and are accepted.

    CONCLUSIONS OF LAW

    
    

27. 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.

    
    

28. The Florida Birth-Related Neurological Injury Compensation Plan (the "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.

    
    

29. 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 within five years of the infant's birth. Sections 766.302(3), 766.303(2), 766.305(1) and 766.313, Florida Statutes. The Florida Birth-Related Neurological Injury Compensation Association (NICA), 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.

    
    

30. 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 Hearing Officer to whom the claim has been assigned. Section 766.305(6), Florida Statutes. If, on the other hand, NICA disputes the claim, as it has in the instant case, the dispute must be resolved by the assigned Hearing Officer in accordance with the provisions of Chapter 120, Florida Statutes. Sections 766.304, 766.307, 766.309 and 766.31, Florida Statutes.

    
    

31. In discharging this responsibility, the Hearing Officer must make the following determination based upon the available evidence:

    
    

    1. Whether the injury claimed is a birth- related neurological injury. If the claimant has demonstrated, to the satis- faction of the hearing officer, 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 substanti- ally 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).

    2. Whether obstetrical services were delivered by a participating physician in the course of labor, delivery, or resus- citation 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 resus- citation in the immediate post-delivery period in a hospital.

       Section 766.309(1), Florida Statutes. An award may be sustained only if the Hearing Officer 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.

32. 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.

    
    

33. As the claimants, the burden rests on petitioners to demonstrate entitlement to compensation. Section 766.309, 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.") That burden may be aided under certain circumstances, such as those presented by the instant case, by the rebuttable presumption afforded by Section 766.309(1), Florida Statutes. Consequently, before addressing the ultimate resolution of this case, it is appropriate to resolve the nature of that rebuttal presumption or, stated differently, whether the presumption is one affecting the burden of producing evidence or one affecting the burden of proof. Sections 90.302-304, Florida Statutes.

    
    

34. Where, as here, a presumption is "established primarily to facilitate the determination of a particular action in which the presumption is applied, rather than to implement public policy, [it] is a presumption affecting the burden of producing evidence." Section 90.303, Florida Statutes. The nature and effect or usefulness of such a presumption in assessing the quality of the proof was addressed in Berwick v. Prudential and Casualty Insurance Company, 436 So.2d 239, 240 (Fla. 3d DCA 1983), as follows:

    
    

    Unless otherwise provided by statute, a presumption established primarily to facilitate the determination of an action, as here, rather than to implement public policy is a rebuttable "presumption affecting the burden of producing evidence, " see Section 90.303, Fla. Stat. (1981), a

    "bursting bubble" presumption, see C. Ehrhardt, supra, at Sections 302.1, 303.1. Such a presumption requires the trier of fact to assume the existence of the presumed fact unless credible evidence sufficient to sustain a finding of the non-existence of the presumed fact is introduced, in which event the bubble bursts and the existence of the fact is determined without regard to the presumption. See [Section] 90.302(1), Fla.

    Stat. (1981); C. Ehrhardt, supra, at [Section] 302.1; see generally Ladd, Presump- tions in Civil Actions, 1977 Ariz.St.L.J. 275 (1977).

    Accord, Public Health Trust of Dade County v. Valcin, 507 So.2d

    596 (Fla. 1987), and Insurance Company of the State of Pennsylvania v. Estate of Guzman, 421 So.2d 597 (Fla. 4th DCA 1982). See also, Gulle v. Boggs, 174 So.2d 26, 29 (Fla. 1965), citing with approval Tyrrell v. Prudential Insurance Co., 109 Vt. 6, 192 A. 184, 115 A.L.R. 392, where in it was stated:

    
    

    Presumptions disappear when facts appear; and facts are deemed to appear when evidence is introduced from which they may be found.

    
    

35. Given the nature of the presumption afforded by subsection 766.309(1)(a) and the presence of credible evidence sufficient to contradict or rebut the presumption that Kallie's injury occurred "in the course of labor, delivery or resuscitation in the immediate post-delivery period in a hospital," the issue of whether Kallie's injury occurred during such period must be "determined on the evidence just as though no presumption ever existed." Caldwell v. Division of Retirement, 372 So.2d 438, 440 (Fla. 1979). 13/

    
    

36. Here, the proof demonstrated that the attending physician who provided obstetric services during the delivery of Kallie was a "participating physician" as that term is defined by Section 766.302(7), Florida Statutes, and as that term is used in Sections 766.301 through 766.316, Florida Statutes. The proof further demonstrated that Kallie suffered an injury to the brain caused by oxygen deprivation which rendered her permanently and substantially mentally and physically impaired; however, the record likewise established, more likely than not, that the insult which resulted in Kallie's injury occurred without the onset of labor and prior to delivery or, stated differently, that the injury did not occur "in the course of labor, delivery, or resuscitation in the immediate post-delivery period in a hospital." Consequently, Kallie's injury was not shown to be a

    "birth-related neurological injury," as defined by law and the subject claim is not compensable under the Plan. Sections 766.302(2) and 766.309(1) Florida Statutes.

    
    

37. Where, as here, the Hearing Officer determines that ".

. . the injury alleged is not a birth-related neurological injury

. . . he [is required to] enter an order [to such effect] and . .

. cause a copy of such order to be sent immediately to the parties by registered or certified mail." Section 766.309(2), Florida Statutes. Such an order constitutes final agency action subject to appellate court review. Section 766.311(1), Florida Statutes.

CONCLUSION

Based on the foregoing Findings of Fact and Conclusions of Law, it is ORDERED that the petition for compensation filed by Cheryl and Richard Luten, individually, and as parents and natural guardians of Kallie Morgan Luten, a minor, be and the same is hereby denied with prejudice.

DONE AND ORDERED this 23rd day of September, 1996 in Tallahassee, Leon County, Florida.

WILLIAM J. KENDRICK, Hearing Officer Division of Administrative Hearings The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-1550

(904) 488-9675

Filed with the Clerk of the Division of Administrative Hearings this 23rd day of September, 1996.

ENDNOTES

1/ Respondent also offered proof at hearing through which it sought to demonstrate that the cause of Kallie's injury, the fetomaternal transfusion, resulted from a congenital abnormality of the placenta, and was therefore not covered under the Plan.

Section 766.302(2), Florida Statutes. Such suggestion, as well as the proof offered to support it, is rejected as unpersuasive and contrary to the more compelling proof that such anomaly is not a congenital abnormality, as that term is used in the Plan.

2/ The Lutens apparently called the office after hours, and reached the answering service. Initially, they asked to speak to the midwife but when the service was unable to reach her they requested to speak with a physician. Dr. Forsthoefel was on call that evening, and returned the Lutens' telephone call.

3/ An external monitor can reliably reflect reactivity and external changes in heart rate, but not variability. [Transcript, page 47.]

4/ The proof demonstrates that the fetomaternal transfusion was not a consequence of a genetic defect or, as heretofore noted, a congenital abnormality.

5/ Kallie is currently microcephalic, epileptic, and suffering from dysphagia, infantile spasms and seizure disorder. She requires a G tube to feed, and cannot hold her head up, roll over, or sit unattended. She has no expressive language and, at age 3, is operating intellectually at the level of a 4 to 5 month old infant.

6/ For compensation to attach under the Florida Birth-Related Neurological Injury Compensation Plan, the injury to the infant's brain, which rendered her neurologically impaired, must have occurred during the course of labor, delivery, or resuscitation in the immediate post-delivery period. Sections 766.302(2) and 766.309(1), Florida Statutes. Consequently, if the proof fails to support such conclusion, the claim is not compensable and Kallie is not subject to the limitations of the Plan, but may pursue her common law remedies. Humana of Florida, Inc. v.

McKaughan, 652 So.2d 852, 859 (Fla. 2d DCA 1995).

7/ In reaching the foregoing conclusion, the testimony of Mrs. Luten that about 10:30 A.M., June 14, 1993, she started having contractions, about 15 to 20 minutes apart, lasting 30 to 60 seconds, and that she continued to have contractions into the early morning of June 15, 1993, has not been overlooked. [Transcript, pages 158 and 159.] However, such testimony was not understood to reflect regular contractions from June 14, 1993 and into the early morning of June 15, 1993, and to the extent it is susceptible of such understanding, as suggested by petitioners at paragraph 26 of their proposed final order, it is rejected as contrary to the more credible proof, supplied by monitoring and her physician's observations, reflecting irregular or sporadic contractions/uterine irritability inconsistent with labor.

8/ Considering that provision, it is observed that when the decision was made at 3:20 A.M. to deliver Kallie by cesarian section, her heart rate was severely depressed and her continued existence in jeopardy. It is further observed that the condition

which precipitated the decision to deliver, sustained bradycardia, commenced at or about 2:55 A.M. and continued until her delivery at 3:36 A.M., as well as for some time thereafter until she was successfully intubated and resuscitated. That time period, at least from the point at which the decision was made to deliver Kallie, including the preparations that then ensued for delivery, would appear facially to be included within "the course of . . . delivery or resuscitation in the immediate post-delivery period." Consequently, timing the fetomaternal hemorrhage proximate to the delivery or decision to deliver, as opposed to a date preceding Mrs. Luten's admission to the hospital, is significant to the resolution of the claim.

9/ Notably, Doctors Forsthoefel, the attending obstetrician, and Cater, the attending neonatologist who resuscitated Kallie, in ascribing the timing of the fetomaternal hemorrhage and Kallie's insult to the time of, or shortly before, Kallie's bradycardia, ignored or largely failed to address the objective evidence of fetal compromise upon Mrs. Luten's admission and over the course of monitoring. See, Martuccio v. Department of Professional Regulation, 622 So.2d 607 (Fla. 1st DCA 1993).

10/ In so concluding, it has not been overlooked that Kallie's heart rate was within a normal range. Such does not, however, detract from the conclusion reached since her heart rate pattern or its characteristics was not normal.

11/ Even petitioners' expert, Dr. Ricardo Ayala, testified that the initial fetal reaction to an acute hemorrhage is fetal tachycardia. [Transcript, page 69.] Yet he opines that the blood loss occurred within an hour of delivery, without explanation as to the absence of acceleration in fetal heart rate.

12/ Dr. Wyele agrees that Kallie suffered a severe fetomaternal transfusion, wherein she dramatically dropped her own body's total blood which, because of its oxygen-carrying material, injured many of her organs, including her brain. However, because of the resiliencies of the fetus she was able to survive the insult. [Transcript, pages 137 and 150.] As for the volume of blood dropped, the record is unclear. Dr. Kalstone testified that of the approximately 250 cc's of blood associated with a fetus at 36 weeks gestation, Kallie dropped "over 50 cc's estimated," which is taken to mean more that 50 cc's but less than 60 cc's. [Respondent's exhibit 1, pages 20 and 31]. Dr.

Cater seemed to likewise speak in terms of 20 percent loss of blood volume [Transcript, pages 106 and 107], but when asked directly about blood volume loss referred to a calculation that could be performed to derive it, but didn't have the pathologist's note. [Transcript, page 107 and 108]. He then

appeared to suggest that volume could be derived based on a normal hemoglobin of 14 or 15 and, considering Kallie's hemoglobin of 2 at delivery, a percentage calculation could be derived. [Transcript, page 108]. If such calculation were an accurate methodology, it would reflect a blood loss of approximately 85 percent of her blood. Given Dr. Cater's uncertainty, his opinion is not persuasive. It is apparent, however, that Kallie did drop a significant amount of blood; however, it was not so great as to threaten for a period of days the survival of the fetus. As for the significance of the bradycardia Kallie suffered immediately prior to her delivery, since it was not related to a concurrent fetomaternal transfusion, it was most likely reflective of the infant's loss of resilience and impending death. [Respondent's exhibit 1, page 13.]

13/ Here, given the proof, the same result would prevail even were the presumption considered a subsection 90.302(2) presumption.

APPENDIX

Petitioners' proposed findings of fact are addressed as follows:

1. Addressed in paragraph 1.

2. Addressed in paragraph 2.

3. Addressed in paragraph 3.

4 and 5. Addressed in paragraphs 5 and 6. Last sentence of paragraph 5 rejected as a mischaracterization of the proof.

1. Addressed in paragraphs 8 and 9.

2. Addressed in paragraph 10.

3. Addressed in paragraphs 9 and 11.

4. Addressed in paragraphs 7 and 9.

10 and 11. Addressed in paragraphs 12 and 13.

1. Addressed in paragraphs 13 and 14.

2. Addressed in paragraphs 14 and 15.

14 and 15. Addressed in paragraphs 16 and 17.

1. Addressed in paragraph 19.

2. To the extent supported by the proof, addressed in endnotes 1 and 4.

3. Addressed in paragraphs 3 and 19, and endnote 5.

4. Addressed in paragraph 19.

20 and 21. Rejected as recitation of testimony, not a finding of fact, and therefore subordinate. It is observed, however, that such summary of testimony is an over simplification and not representative of the doctor's observations and opinions.

1. Rejected as recitation of testimony, not a finding of fact, and therefore subordinate. It is observed, however, that although Dr. Forsthoefel did testify that the baby's heart rate

   was within normal range, she did not so opine as to variability, since the monitor could not measure it. See, paragraph 23 and endnote 3 and 10.

2. Rejected as recitation of testimony, not a finding of fact, and therefore subordinate. It is observed, however, that Dr. Ayala did not testify that if the anoxic event had occurred

   48 hours prior to delivery Kallie would have been born hydropic (water swollen). See transcript, page 68, where Dr. Ayala explains that when the bleed "occurs on a chronic basis, that is

   . . . it's been occurring for several weeks or months, we tend to notice that these babies typically will come out hydropic. "

   Had he testified, as represented by petitioner, it would have been contrary to his own observations. See Transcript, pages 68 and 69. Counsel apparently misperceives or chooses to ignore the dichotomy between a chronic and acute bleed and the respective presentations of the infant.

3. Rejected as recitation of testimony, not a finding of fact, and therefore subordinate. It is observed, however, that Dr. Cater did not testify that if the blood loss had occurred more than 12 hours prior to delivery Kallie would have been edemous and swollen. See, transcript, pages 106 and 107. See also, response to paragraph 23.

4. Addressed in paragraph 22 and endnote 9, otherwise unnecessary detail.

5. First sentence addressed in endnote 7. Second and third sentence subordinate, and addressed in paragraph 20. Last sentence rejected as contrary to the proof, and addressed in paragraph 10.

27 and 28. Rejected as argument, but addressed in paragraphs 20 and 21.

1. Rejected as subordinate or argument, but addressed in endnotes 1 and 4.

2. First sentence, rejected as argument and contrary to the facts as found. Second sentence rejected as comment on the evidence or argument. Further, see endnote 3.

3. First sentence accepted as their testimony, but subordinate. Second sentence accepted as his testimony, but subordinate. Last sentence accepted, but subordinate and of little import considering Dr. Wyele's testimony considered in toto. Moreover, Kallie did not suffer seizures immediately following birth, but almost 6 months later.

4. First sentence accepted, but subordinate. Second and third sentence rejected as argument, and contrary to the proof. See response to paragraphs 23 and 24. Last sentence accepted in part, but rejected that Dr. Wyele relies solely on the ultrasounds to support his opinion that the incident occurred earlier. See paragraphs 24 through 26.

5. First sentence accepted as their testimony, but subordinate and relevance to a fetus not demonstrated. Second sentence rejected as not supported by competent or persuasive

   proof, and contrary to the more credible proof. See endnote 12. Last sentence, accepted as their testimony, but subordinate.

6. Rejected as argument, not a finding of fact, and in large measure misleading. Dr. Wyele's observation was that the injury to Kallie's brain, as distinguished from the onset of the fetomaternal hemorrhage, had to be more than 24 hours before delivery because her first three days of life were inconsistent with a later insult. As to the timing, the absence of cerebral edema (by cranial ultrasound) at approximately 25 hours of life is consistent with such observation. That cerebral edema could occur and resolve between ultrasounds does not support the conclusion that Kallie's insult occurred at birth and does not detract from Dr. Wyele's analysis and conclusion that her presentation was not consistent with an insult within 24 hours of delivery. Indeed, Dr. Wyele's rationale was largely unaddressed by petitioners.

7. First sentence accepted as her testimony, but

   subordinate. Second sentence addressed in paragraphs 15 and 19.

8. Rejected as contrary to the more credible and persuasive proof, and the facts as found. See paragraphs 4 through 26.

COPIES FURNISHED:

(By certified mail)

Lynn Dickinson, Executive Director Florida Birth-Related Neurological

Injury Compensation Association Post Office Box 14567 Tallahassee, Florida 32317-4567

Kristin Adamson, Esquire Novey, Mendelson and Adamson 851 East Park Avenue Tallahassee, Florida 32301

W. Douglas Moody, Jr., Esquire BATEMAN GRAHAM, P.A.

300 East Park Avenue Tallahassee, Florida 32301

Jana M. Bures-Forsthoefel, M.D. 1405 Centerville Road

Tallahassee, Florida 32308

Tallahassee Memorial Regional Medical Center

Legal Department

Magnolia Drive and Miccosukee Road

Tallahassee, Florida 32308

Ms. Tanya Williams

Agency for Health Care Administration Division of Health Quality Assurance 2727 Mahan Drive, Hospital Section Tallahassee, Florida 32308

Ms. Charlene Willoughby Department of Business and

Professional Regulation Consumer Services

1940 North Monroe Street Tallahassee, Florida 32399-0784

Dan Sumner, General Counsel Department of Insurance

The Capitol, Plaza Level 11 Tallahassee, Florida 32399-0300

NOTICE OF RIGHT TO JUDICIAL REVIEW

A party who is adversely affected by this final order is entitled to judicial review pursuant to Sections 120.68 and 766.311, Florida Statutes. Review proceedings are governed by the Florida Rules of Appellate Procedure. Such proceedings are commenced by filing 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.

Docket for Case No: 95-003708N

Orders for Case No: 95-003708N