01-004889N Mario Balandra And Rosemary Balandra, On Behalf Of And As Parents And Natural Guardians Of Sophia Balandra, A Minor vs. Florida Birth-Related Neurological Injury Compensation Association Status: Closed DOAH Final Order on Thursday, October 3, 2002.

Summary: Proof demonstrated that, more likely that not, infant`s injury occurred prior to cesarean delivery. Consequently, since mother was never in labor, claim was not compensable.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

MARIO BALANDRA and ROSEMARY )

BALANDRA, as parents and )

natural guardians of SOPHIA )

BALANDRA, a minor, )

)

Petitioners, )

)

vs. ) Case No. 01 - 4889N

)

FLORIDA BIRTH - RELATED )

NEUROLOGICAL INJURY )

COMPENSATION ASSOCIATION, )

)

Respo ndent. )

)

FINAL ORDER

Pursuant to notice, the Division of Administrative Hearings,

by Administrative Law Judge William J. Kendrick, held a final

hearing in the abov e - styled case on August 26, 2002, by video

teleconference, with sites in Tallahassee and Fort Myers,

Florida.

APPEARANCES

For Petitioner: Mario Balandra

and Rosemary Balandra, pro se

3929 Groveland Avenue

Sarasota, Florida 34231

For Respondent: Lynn Walker Wright, Esquire

Wright, Railey & Harding, P.A.

2716 Rew Circle, Suite 102

Ocoee, Florida 34761

STATEMENT OF THE ISSUE

At issue in this proceeding is whether Sophia Balandra, a

minor, qualifies for coverage under the Florida Birth - Related

Neurological Injury Compensation Plan.

PRELIMINARY STATEMENT

On December 24, 2001, Mario Balandra and Rosemary Balandra,

as parents and natural guardians of Sophia Balandra (Sophia), a

minor, filed a petition (claim) with the Division of

Administrative Hearings (DOAH) for compensation under the Florida

Birth - Related Neurological Injury Compensation Plan (Plan).

DOAH served t he Florida Birth - Related Neurological Injury

Compensation Association (NICA) with a copy of the claim on

December 24, 2001. NICA reviewed the claim, and on April 1,

2002, gave notice that it had "determined that such claim is not

a 'birth - related neurolog ical injury' within the meaning of

Section 766.302(2), Florida Statutes," and requested that "an

order [be entered] setting a hearing in this cause on the issue

of . . . compensability." Such a hearing was duly - noticed for,

and held on, August 26, 2002.

At hearing, the parties stipulated to the factual matters

set forth in paragraphs 1, 2, and 4 of the Findings of Fact.

Rosemary Balandra testified on behalf of Petitioners, and

Petitioners' Exhibits 1A and 1B (the medical records, two

volumes, filed with DOAH on December 24, 2001), as well as

Petitioners' Exhibit 2 (a report of neurological evaluation by

Michael Duchowny, M.D., dated March 19, 2002), were received into

evidence. Respondent called no witnesses; however, Respondent's

Exhibit 1 (the deposit ion of Donald Willis, M.D., filed with DOAH

on July 31, 2002) was received into evidence.

The transcript of hearing was filed on September 9, 2002,

and the parties were accorded 10 days from that date to file

proposed final orders. Respondent elected to f ile such a

proposal, and it has been duly - considered.

FINDINGS OF FACT

Preliminary findings

1. Petitioners, Mario Balandra and Rosemary Balandra, are

the parents and natural guardians of Sophia Balandra. Sophia was

born a live infant on January 2, 199 7, at Sarasota Memorial

Hospital, a hospital located in Sarasota, Florida, and her birth

weight exceeded 2,500 grams.

2. The physician providing obstetrical services at Sophia's

birth was Michael S. Finazzo, 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

3. 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 . . . occurring in the course of labor, delivery, or

resuscitation in the immediate post - delivery period in a

hospital, which renders the infant per manently and substantially

mentally and physically impaired." Sections 766.302(2) and

766.309(1)(a), Florida Statutes.

4. Here, it is undisputed, and the parties have so

stipulated, that Sophia suffered an injury to the brain, caused

by oxygen deprivatio n, which rendered her permanently and

substantially mentally and physically impaired. Consequently,

with regard to the issue of compensability, the only issue that

remains for resolution is whether the proof supports the

conclusion that, more likely than not, Sophia's brain injury

occurred in the course of labor, delivery, or resuscitation in

the immediate post - delivery period, as required for coverage

under the Plan.

Mrs. Balandra's antepartum course and Sophia's birth

5. Mrs. Balandra's antepartum cour se was without

significant complication until January 2, 1997, when, with the

fetus at approximately 38 weeks gestation (estimated date of

delivery January 17, 1997), she presented to her obstetrician's

office complaining of decreased fetal movement. 1 At the time,

auscultation revealed a low fetal heart rate (in the 90 - beat per

minute range), and it was thought that Mrs. Balandra may have "a

fetus with a heart block or . . . [that] deceleration was

occurring." Given the circumstances, Mrs. Balandra was re ferred

to Sarasota Memorial Hospital for further monitoring and

assessment.

6. Mrs. Balandra was admitted to Sarasota Memorial Hospital

at or about 4:56 p.m., January 2, 1997. At the time, external

fetal monitoring revealed a fetal heart tone of 140 - 144 beats -

per - minute, with minimum variability. Biophysical profile,

completed at or about 5:24 p.m., was nonreassuring, at 4/8, with

2 points deducted for lack of fetal movement and 2 points

deducted for lack of fetal tone.

7. At 5:40 p.m., fetal heart ton e was noted as 150 - 160

beats per minute (a mild fetal tachycardia). Shortly thereafter,

Dr. Finazzo was apprised of Mrs. Balandra's status, and he

ordered that she be prepared for cesarean section. At the time,

Mrs. Balandra was not in labor, and she wou ld not thereafter be

in labor at anytime prior to Sophia's delivery. Dr. Finazzo's

assessment and plan were, as follows:

ON REVIEW THE ASSESS MENT WAS THAT THE PA TIENT

HAD AN INTRAUTERINE PREGNANCY AT 38 WEEK S

GESTATION WITH A PRE VIOUS CESAREAN SECTI ON

AND THE PATIENT DESIRED A REPEAT CESAREAN

SECTION. SHE HAS EX PRESSED DESIRE IN TH E

PAST TO HAVE A BILAT ERAL TUBAL LIGATION BUT

GIVEN THE FACT THAT THERE IS POTENTIAL F ETAL

HARM, THE PATIENT HA S OPTED TO GIVE ME T HE

AUTHORITY TO DECIDE WHETHER OR NOT TO PR OCE ED

WITH TUBAL LIGATION OR NOT AS SHE CLAIMS THAT

IF I THOUGHT THE BAB Y WOULD NOT SUBSEQUE NTLY

DO WELL, DO NOT DO T HE TUBAL LIGATION. THIS

WAS DISCUSSED WITH T HE PATIENT, BOTH

PREOPERATIVELY AND I NTRAOPERATIVELY. SH E HAD

BEEN EXPLAINED THE O NE IN THREE HU NDRED

FAILURE RATE OF THIS OPERATION, ITS

IRREVERSIBLE NATURE AND THAT REVERSIBLE

METHODS OF BIRTH CON TROL ARE AVAILABLE. SHE

ACCEPTED ALL OF THIS AND LEFT THIS AUTHO RITY

UP TO ME BASED UPON HOW THE FETUS IS TO DO.

PLAN:

WILL PROCEED WITH CE SAREAN SECTI ON AND

POSSIBLE BILATERAL T UBAL LIGATION UNDER

SPINAL ANESTHESIA. WILL GO AS SOON AS

POSSIBLE WHEN ANESTH ESIA HAS PREPARED AN D

WILL CONTINUE CLOSE MONITORING IN IMMEDI ATE

PREOPERATIVE PERIOD. IN ADDITION, THE

PATIENT HAD A CULTUR E THAT WAS POSITIVE FOR

G ROUP B STREPTOCOCCUS ONE WEEK AGO AND SH E

WILL BE GIVEN PROPHY LACTIC ANTIBIOTIC

AMPICILLIN OR UNASYN BEFORE THIS PROCEDU RE.

8. At 5:45 p.m., fetal heart tone was noted to decrease to

70 beats per minute for 20 seconds, then increase to 90 - 110 beats

per m inute for 70 seconds, and then increase to 90 - 120 beats per

minute for 30 seconds, followed by a return to baseline.

Thereafter, at 5:55 p.m., fetal heart tone was noted at 155 - 160

beats per minute, with minimum to average variability, and

Mrs. Balandra's abdomen was prepared for surgery.

9. At 6:05 p.m., when Dr. Finazzo arrived at labor and

delivery, fetal heart tone was noted as 158 - 164 beats per minute,

with no further decelerations. Thereafter, at 6:10 p.m.,

Mrs. Balandra was transported, via bed, t o the operating room.

10. According to the records, Mrs. Balandra was in the

operating room at 6:15 p.m., anesthesia started at 6:15 p.m.,

surgery started at 6:42 p.m., and Sophia was delivered at

6:50 p.m. Pertinent to this case, Dr. Finazzo's operativ e notes

describe Sophia's delivery, as follows:

. . . A LOW - TRANSVER SE INCISION WAS MADE INTO

THE UTERUS. THIS WA S EXTENDED BILATERAL LY IN

ELLIPTICAL FASHION U SING THE TWO INDEX

FINGERS. A MODERATE AMOUNT OF MECONIUM FLUID

WAS NOTED. A HAND W AS THEN PLA CED INTO THE

UTERINE CAVITY AND T HE FETAL HEAD WAS FL EXED,

ELEVATED AND BROUGHT OUT THROUGH THE UTE RINE

INCISION. THE NARES AND OROPHARYNX WERE

SUCTIONED USING THE DELEE TO RETRIEVE AN Y

POTENTIAL MECONIUM, AND THE REST OF THE

BABY'S BODY WAS DELI VERED ATR AUMATICALLY.

AFTER IT WAS DELIVER ED, THE CORD WAS CLA MPED

TIMES TWO AND CUT, A ND THE BABY WAS HAND ED TO

THE WAITING NEONATOL OGIST.

THE CORD WAS CLAMPED CLOSE TO THE FETAL

UMBILICUS AS THERE W AS A SEGMENT OF CORD THAT

APPEARED TO BE ABNOR MAL, A THROMBOSIS OR

ANEURYSM OR BLEEDING INTO THE CORD AT TH IS

SITE. AT THIS TIME, THIS EXTRA SEGMENT OF

CORD WAS ISOLATED, C LAMPED AND SENT TO T HE

PATHOLOGIST. THE RE ST OF THE CORD WAS U SED

TO COLLECT CORD BLOO D AND COLLECT CORD A BG.

* * *

AFTER A SINGLE FIGUR E - OF - EIGHT OF 0 MONOC RYL

WAS USED TO OBTAIN C OMPLETE HEMOSTASIS, A

DECISION WAS MADE NO T TO PROCEED WITH

BILATERAL TUBAL LIGA TION. THIS WAS DONE IN

CONSULTATION WITH TH E PATIENT AS BEFORE

SURGERY, THE PATIENT HAD TOLD ME SHE ONL Y

WANTED TUBAL LIGATIO N DONE IF I COULD BE SURE

THAT THE NEWBORN WAS DOING WELL AND WOUL D NOT

HAVE ANY LONG - TERM P ROBLEMS OR POTENTIAL FOR

NEONATAL DEATH. THE APGARS AT THAT TIME WERE

5 [AT ONE MINUTE] AN D 6 AT FIVE MINUTES.

THEREFORE, A DECISIO N WAS MADE NOT TO PR OCEED

WITH TUBAL LIGATION. THE PATIE NT AGREED WITH

THIS AT THE TIME OF SURGERY . . . .

11. Sophia's course after she was handed to the waiting

neonatologist, John S. Gallagher, M.D., and until 7:10 p.m., when

she was transferred to the neonatal intensive care unit (NICU )

for further observation and therapy, was detailed in

Dr. Gallagher's History and Physical, as follows:

APGARS WERE 5, 6 AND 8 AT ONE, FIVE AND TEN

MINUTES RESPECTIVELY .[ 2 ] AT DELIVERY, THER E

WAS SOME MODERATE ME CONIUM NOTED AND THE BABY

WAS WELL DELEE S UCTIONED AFTER DELIV ERY OF

THE HEAD BY DR. FINA ZZO . . . .

THE BABY MADE A FEW GASPING EFFORTS AT T HAT

POINT BUT WAS FLOPPY AND SO THE CORDS WE RE

VISUALIZED AND I PAS SED A SUCTION CATHET ER

PAST THE CORD. [I] OBTAIN[ED] A SMALL A MOUNT

OF WATERY MECONIUM F LUID WHICH QUICKLY

CLEARED. [AT 6:51 P .M., THE BABY WAS GI VEN

BLOWBY OXYGEN.] I T HEN STIMULATED THE B ABY

AND HAD GOOD HEART R ATE BUT VIRTUALLY NO

RESPIRATORY EFFORT. FOR THAT REASON, SH E WAS

INTUBATED WITH A 3.5 ENDOTRACHEAL TUBE. A

MECONIUM ASPIRATOR WAS USED AND NO MECO NIUM

WAS OBTAINED AT THAT POINT. [AT 2 1/2

MINUTES(6:52.5 P.M.) ] WE AGAIN EXTUBATE D THE

BABY, SUCTIONING AS WE WITHDREW THE TUBE . WE

THEN CONTINUED DRYIN G AND STIMULATING TH E

BABY BUT AGAIN SAW P OOR RESPIRATORY EFFO RT

AND COLOR AND [ AT 6:53 P.M., AND CO NTINUING

UNTIL 6:54 P.M.] GAV E BAG AND MASK

VENTILATION WHICH KE PT THE HEART RATE AB OVE

100 BUT FAILED TO RE INSTITUTE RESPIRATIO NS.

AT THIS POINT, IT SE EMED THAT THE BABY H AD

SOME SECONDARY APNEA AND SO [AT 6:54 P.M .] WE

AGAIN INTUBATE D HER, THIS TIME WIT H A 3.0

ENDOTRACHEAL TUBE AN D RESUMED SUCTIONING AND

BAGGING. SOME MECON IUM WAS OBTAINED WIT H

DEEP SUCTIONING THRO UGH THE TUBE AT THIS

POINT, AND IT DID CL EAR. WE USED A SMAL L

AMOUNT OF SALINE TO HELP ENSURE THAT THE

PROXIMAL AIRWAY W AS CLEAR AS WELL AND THIS

DID CLEAR READILY. BREATH SOUNDS WERE E QUAL

AND GENERALLY CLEAR WITH GOOD CHEST MOVE MENT

WITH THE BAGGING ON LOW PRESSURE, WHICH WAS

ALWAYS KEPT IN THE T EENS TO LOW 20'S,

SUFFICIENT TO KEEP T HE HEART RATE UP AND

IMPROVE THE COLOR . THE ENDOTRACHEAL TUBE WAS

KEPT AT ABOUT 8 CM. AND AGAIN AS NOTED,

BREATH SOUNDS WERE E QUAL.

WE CONTINUED THE BAG GING AND PULMONARY

SUCTIONING AND LAVAG E FOR THE NEXT SEVER AL

MINUTES AND THE BABY 'S RESPIRATORY EFFOR TS

GRADUALLY BECAME MOR E CONSISTENT. BY AROUND

THE SEVEN MINUTE MAR K [6:57 P.M.], THE B ABY

WAS MAKING FAIRLY CO NSISTENT RESPIRATORY

EFFORTS. BY AROUND 15 MINUTES OR SO [7: 05

P.M.], WE HAD EXTUBA TED AGAIN [AND CEASE D

BAGGING], AS THE LUN GS SOUNDED CLEAR AND

THERE WAS NO FURTHER MECONIUM.

* * *

THE BABY WAS BROUGHT TO THE SPECIAL CARE

NURSERY FOR FURTHER OBSERVATION AND THER APY

INCLUDING ANTIBIOTIC S GIVEN THE GROUP - B STREP

HISTORY.

PHYSICAL EXAMINATION:

GENERAL DESCRIPTION: THE BABY IS AN

APPROXIMATELY TERM FEMALE WITH IMPROVED

RESPIRA TORY EFFORT AND GOOD PERFUSION BUT

SATURATION DIPPING IN THE LOW 80'S ON ROOM

AIR, AND SO BABY WAS PLACED INTO HOOD OXYGEN

WITH IMPROVEMENT IN SATURATION TO THE UPPER

90'S.

HEAD, EYES, EARS, NOSE AND THROAT:

FONTANELLE IS SOFT.

CHEST: SYMMETRICAL WITH EQUAL AND RATHER

CLEAR BREATH SOUNDS WITH FAIR GOOD EXCHANGE.

CARDIOVASCULAR: THERE IS NO MURMUR. THE

PULSES AND PERFUSION ARE GOOD.

ABDOMEN: SOFT. THE BABY'S TONE IMPROVED,

ALTHOUGH REFLEX IRRITABILITY STILL SOMEWHAT

DIMINISHED.

WE WILL OBTAIN A CBC AND BLOOD CULTURE AND

START ANTIBIOTICS AS NOTED. ALSO WILL OBTAIN

A CHEST RADIOGRAPH TO MONITOR FOR ANY

ASPIRATION EFFECT. CHEM - STRIP IS ALSO

PENDING.

* * *

ADMISSION IMPRESSIONS:

1) TERM FEMALE.

2) STATUS POST PERINATAL STRESS, PERHAPS

R ELATED TO GESTATIONAL DIABETES AND UMBILICAL

CORD HEMATOMA WITH LOW BIOPHYSICAL PROFILE

AND CORD PH.

3) APPARENT MECONIUM, AT LEAST IN THE

PROXIMAL AIRWAYS, RULE OUT ASPIRATION.

4) RULE OUT SEPSIS.

12. At or about 7:50 p.m., following her admission t o the

special care nursery, Sophia's oxygen saturation levels began to

fall and she was re - intubated. Dr. Gallagher's progress note

regarding the event read, as follows:

THE BABY, DESPITE HAVING RELATIVELY CLEAR

LUNGS STARTED DROPPING HER OXYGEN SATURATIO N

AND HAD LOW BLOOD PRESSURES AND IS STARTED

NOW ON DOPAMINE AND HAD NEGATIVE

TRANSILLUMINATION OF THE CHEST WITH STAT

CHEST X - RAY. WE HAVE RE - INTUBATED THE BABY

AND THERE ARE SOME COURSE BREATH SOUNDS BUT

WE HAVE NOT OBTAINED ANY MORE MECONIUM, AS

YET. OBVIOUSLY, THE BABY IS AT SOME RISK FOR

ASPIRATION PNEUMONITIS AND PERHAPS, PULMONARY

HYPERTENSION AND WILL TRY TO MAINTAIN THE

OXYGEN SATURATIONS AS BEST WE CAN AND SEE

WHAT MIGHT BE CONTRIBUTING LOW BLOOD PRESSURE

AT THIS POINT. WE HAVE ALREADY STARTED

DOPAMINE AND WILL GIVE VOLUME BOLUS AS NEEDED

AS WELL.

13. On January 3, 1997, the first postnatal day, Sophia

remained in serious condition. Dr. Gallagher's progress note

regarding her presentation that day read, as follows:

THE PATIENT HAS CONTINUED T O HAVE SEVERE

METABOLIC ACIDOSIS OVERNIGHT. [S]HE HAS THUS

FAR HAD NO URINE OUTPUT. WE HAVE KEPT THE

FLUID SOMEWHAT RESTRICTED IN TERMS OF THE

INTRAVENOUS BECAUSE OF THE INITIAL FETAL

STRESS AND THE NEED FOR RESUSCITATIVE

MEASURES, BUT, OF COURSE, WE HAV E GIVEN SOME

BOLUSES OVERNIGHT OF BICARB AND HAVE GIVEN A

SALINE BOLUS EARLIER.

THE PULSE PRESSURES AND MEAN BLOOD PRESSURES

HAVE BEEN GOOD OVERNIGHT ON ABOUT EIGHT

MICROGRAMS OF DOPAMINE. THE PERFUSION IS

IMPROVED FROM EARLIER THIS MORNING, BUT IT IS

ST ILL AROUND THREE TO FOUR SECONDS.

* * *

THE INITIAL CBC HAD SHOWN MARKED ELEVATION OF

THE WHITE COUNT AROUND 50,000 WITH REPEAT

PENDING TODAY. I HAVE BEEN TOLD THAT

OVERNIGHT MOTHER HAD DEVELOPED FEVER AS WELL.

* * *

THE BABY IS SOMEWHAT MORE ACTIVE AND ALERT

THIS MORNING DESPITE THE ONGOING ACIDOSIS,

AND THE PUPILS APPEAR TO BE SOMEWHAT DILATED

AND DO REACT. FONTANELLE IS SOFT, AND THE

BABY MOVES ALL EXTREMITIES WHEN STIMULATED.

THIS MOST LIKELY REPRESENTS OVERWHELMING

SEPSIS, AND THE OVERAL L PROGNOSIS IS

UNCERTAIN AT THIS POINT . . . .

14. Sophia remained hospitalized until January 30, 1997,

when she was discharged to her parent's care. Apart from matters

previously discussed, Sophia's history was described in

Dr. Gallagher's discharge summary, as follows:

THERE WAS QUESTION OF SEIZURE ACTIVITY

OBSERVED AND BABY WAS STARTED ON

PHENOBARBITAL BY THE FIRST POSTNATAL DAY.

THERE WAS IMPROVING METABOLIC ACIDOSIS BY DAY

TWO BUT STILL SOME LABILE OXYGENATION.

BY DAY THREE, THE BABY WAS WEANING SOMEWHAT

ON HIGH FREQUENCY VENTILATOR, HAD BILATERAL

AIR BRONCHOGRAMS THOUGHT TO BE CONSISTENT

WITH EITHER PNEUMONITIS OR RESPIRATORY

DISTRESS SYNDROME.

THE BABY ALSO DEVELOPED SOME THROMBOCYTOPENIA

DURING THIS TIME AND ELEVATION OF THE WHITE

COUNT BUT T HE CLINICAL COURSE WAS CONSISTENT

WITH SOME SORT OF AN INFECTIOUS PROCESS,

PERHAPS A VIRAL PNEUMONITIS, ALTHOUGH THERE

WAS NO CONFIRMATION OF THAT AT DISCHARGE.

OVER THE NEXT SEVERAL DAYS, THE BABY

CONTINUED ON HIGH FREQUENCY VENTILATION UP TO

100 PERCENT OXYGEN WITH PRESUMED PULMONARY

HYPERTENSION DURING THIS TIME AS WELL. AIR

FLUID INTAKE WAS SUGGESTED AS POSSIBLE TO

IMPROVE THE OUTPUT AND SHE REQUIRED SOME

ONGOING SEDATION AS WELL.

THE EEG WAS DEFERRED INITIALLY BECAUSE OF THE

HIGH FREQUENCY VENTILATO R.

THE BABY WAS TREATED PRESUMPTIVELY WITH

ACYCLOVIR COURSE AS WELL ALTHOUGH THERE WAS

NO GROWTH OF HFC ON THE CULTURES.

SHE GRADUALLY WEANED FROM FENTANYL DRIP.

INITIAL ORGANIC ACID STUDIES WERE ALL

ELEVATED, PRESUMABLY SECONDARY TO THE SEVERE

METABOLI C ACIDOSIS AND THERE WAS NO ONGOING

METABOLIC ACIDOSIS AT THAT POINT.

AROUND DAY 13, THE BABY WAS EXTUBATED AND

SUBSEQUENTLY STARTED ON FEEDINGS. EEG AROUND

THIS TIME WAS ABNORMAL WITH ATTENUATED

BACKGROUND RHYTHM AND EXCESSIVE

DISCONTINUITY. WAS THOUGH T TO BE CONSISTENT

WITH DIFFUSE CEREBRAL DYSFUNCTION WITH NO

SUBCLINICAL SEIZURE ACTIVITY NOTED ON IT.

THE BABY HAD SOME DIFFICULTY ADVANCING ON

FEEDINGS, WAS JITTERY AT TIMES WITH WEAK CRY

AND SUCK AND HAD MRI PERFORMED SUBSEQUENTLY

WHICH SHOWED SIGNS OF MULTICYSTIC

ENCEPHALOMACIA.

THE BABY DEVELOPED SOME COLD STASIS RELATED

TO THE PROLONGED HYPERALIMENTATION.

THE BABY WAS DISCHARGED TO FOLLOW - UP WITH

NEUROLOGIST AT ALL CHILDREN'S AND ALSO DR.

PETRUSKY FOR THE FOLLOWING WEEK.

ARRANGEMENTS WERE MADE WIT H THE EIP PROGRAM

AS WELL.

DISCHARGE MEDICATIONS: PHENOBARBITAL 6 MG

Q.12.

FINAL DIAGNOSES:

1. TERM FEMALE.

2. STATUS POST PERINATAL STRESS WITH

APPARENT HYPOXIC ISCHEMIC ENCEPHALOPATHY AND

EVIDENCE OF ENCEPHALOMACIA ON MRI. THERE WAS

ALSO INITIAL SEVERE METABOLIC ACIDOSIS AND

CLINICAL SEIZURES ASSOCIATED WITH THIS.

3. APPARENT PNEUMONITIS, RESOLVED WITH

NEGATIVE CULTURES.

The timing of Sophia's neurologic injury

15. To address the issue of whether Sophia's brain injury

occurred "in the course of labor, delivery, or resuscitation in

the immediate post - delivery period," as required for coverage

under the Plan, Petitioners offered selected medical records

relating to Mrs. Balandra's antepartum course, as well as those

associated with Sophia's birt h and subsequent development.

Additionally, Mrs. Balandra testified on her own behalf, and

Respondent offered the testimony of Dr. Donald Willis, a

physician board - certified in obstetrics and gynecology, as well

as maternal - fetal medicine.

16. As for the timing of Sophia's injury, it was

Dr. Willis' opinion, based on his review of the medical records,

that Sophia's brain injury, and her ensuing neurological

impairment, occurred prior to delivery. 3 In so concluding,

Dr. Willis noted that when Mrs. Balandr a presented to her doctor

on the day of delivery, she complained of decreased fetal

movement, that during auscultation of the fetal heart rate in the

doctor's office the fetal heart rate was low (into the 90 - beat

per minute range), and that when she presen ted at the hospital,

her biophysical profile was abnormal, with a score of four out of

eight. Dr. Willis further observed, that following admission,

the fetal monitor strip revealed mild fetal tachycardia, with

poor heart rate variability, and a spontaneo us deceleration to 70

beats per minute. Moreover, Dr. Willis noted that on delivery,

Sophia's Apgar scores were depressed (at five, six, and eight, at

1, 5, and 10 - minutes respectively), and the umbilical cord artery

Ph was low, at 6.97 (acidotic). Final ly, Dr. Willis noted "an

umbilical artery Doppler [was done] which showed absent in -

diastolic flow . . . a sign of placental problems which . . .

[are] associated with fetal distress."

17. In contrast to the proof offered by Respondent

regarding the t iming of Sophia's injury, Petitioners offered no

medical testimony regarding the timing of Sophia's injury.

Consequently, given that Dr. Willis' opinion is logical and

consistent with the other evidence, it must be resolved that

Sophia's injury occurred p rior to delivery and that, since

Mrs. Balandra was not in labor at the time, Sophia's injury does

not qualify for coverage under the Plan. See , e.g. , Vero Beach

Care Center v. Ricks , 476 So. 2d 262, 264 (Fla. 1st DCA

1985)("[L]ay testimony is legally insu fficient to support a

finding of causation where the medical condition involved is not

readily observable."), and Thomas v. Salvation Army , 562 So. 2d

746, 749 (Fla. 1st DCA 1990)("In evaluating medical evidence, a

judge of compensation claims may not reje ct uncontroverted

medical testimony without a reasonable explanation.")

CONCLUSIONS OF LAW

18. The Division of Administrative Hearings has

jurisdiction over the parties to, and the subject matter of,

these proceedings. Section 766.301, et seq. , Florida S tatutes.

19. 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 o n or after January 1, 1989. Section 766.303(1),

Florida Statutes.

20. 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 Ad ministrative 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 cla im . . . 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.

21. If NICA determines that the inj ury 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 Stat utes. If, however,

NICA disputes the claim, as it has 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 7 66.31,

Florida Statutes.

22. In discharging this responsibility, the administrative

law judge must make the following determination based upon the

available evidence:

(a) Whether the injury claimed is a birth -

related neurological injury. If the claima nt

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

m entally and physically impaired, a

rebuttable presumption shall arise that the

injury is a birth - related neurological injury

as defined in s. 766.303(2).

(b) Whether obstetrical services were

delivered by a participating physician in the

course of labo r, 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 - deliv ery 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.

23. 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 infa nt 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

substanti ally 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.

24. As the claimants, the burden rested on Petitioners to

demonstrate entitleme nt to compensation. 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 affirmat ive issue before an administrative

tribunal").

25. Here, given that Mrs. Balandra was never in labor, and

Sophia's brain injury occurred prior to delivery, the proof

failed to support the conclusion that, more likely than not,

Sophia 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 the hospital that rendered her permanently and

substantially mentally and physically impaired . Consequently,

the record developed in this case failed to demonstrate that

Sophia suffered a "birth - related neurological injury," within the

meaning of Section 766.302(2), Florida Statutes, and the subject

claim is not compensable under the Plan. Secti ons 766.302(2),

766.309(1), and 766.31(1), Florida Statutes. See also Florida

Birth - Related Neurological Injury Compensation Association v.

Florida Division of Administrative Hearings , 686 So. 2d 1349

(Fla. 1997), and Nagy v. Florida Birth - Related Neurolo gical

Injury Compensation Association , 813 So. 2d 155 (Fla. 4th DCA

2002).

26. Where, as here, the administrative law judge 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

76 6.311(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

Mario Balandra and Rosemary Balandra, as parents and natural

guardians of Sophia Balandra, a minor, be and the same is hereby

denied with prejudice.

DONE AND ORDERED this 3rd day of October, 2002, in

Tallahassee, Leon County, Florida.

___________________________________

WILLIAM J. KENDRICK

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399 - 3060

( 850) 488 - 9675 SUNCOM 278 - 9675

Fax Filing (850) 921 - 6847

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 3rd day of October, 20 02.

ENDNOTES

1/ While Mrs. Balandra's antepartum course was without

significant complication until January 2, 1997, she did present

with a number of risk factors, including advanced maternal age,

and a history of previous cesarean section and gestati onal

diabetes (with the birth of her first child). Under such

circumstances, Mrs. Balandra underwent antepartum testing

(nonstress test, with amniotic fluid assessment) twice weekly

from December 17, 1996, through December 31, 1996. All tests

were reassu ring, with reactive nonstress test and normal amniotic

fluid index. Additionally, on December 18, 1996, following an

automobile accident, Mrs. Balandra had a biophysical profile done

at Sarasota Memorial Hospital, which was likewise reassuring with

a maxi mum score of 8 out of 8 ("8/8") for fetal tone (2 points),

fetal breathing (2 points), fetal movement (2 points), and

amniotic fluid volume (2 points).

2/ The Apgar scores assigned to Sophia are a numeric expression

of the condition of a newborn infant, and reflect the sum points

gained on assessment of heart rate, respiratory effort, color,

muscle tone, and reflex irritability, with each category being

assigned a score ranging from the lowest score of 0 through a

maximum score of 2. As noted, at one min ute, Sophia's Apgar

score totaled 5, with heart rate being graded at 2; respiratory

effort, muscle tone, and reflex irritability being graded at 1

each; and color being graded at 0. At five minutes, Sophia's

Apgar score totaled 6, with heart rate being gr aded at 2, and

respiratory effort, color, muscle tone, and reflex irritability

being graded at 1 each. At ten minutes, Sophia's Apgar score

totaled 8, with heart rate, respiratory effort, and reflex

irritability being graded at 2 each, and color and muscl e tone

being graded at 1 each. Such scores are low, and evidence of

significant depression at birth.

3/ Here, since Sophia was delivered by cesarean section, it may

be stated that delivery began at 6:42 p.m., when the cesarean

section began and ended at 6:50 p.m., when Sophia was removed

from the uterus. As for resuscitation in the immediate post -

delivery period, "The Delivery Resuscitation Sheet" reflects that

such period ran from Sophia's delivery at 6:50 p.m., until

approximately 7:05 p.m.

COPIES F URNISHED:

(By certified mail)

Mario Balandra

Rosemary Balandra

3929 Groveland Avenue

Sarasota, Florida 34231

Lynn Walker Wright, Esquire

Wright, Railey & Harding, P.A.

2716 Rew Circle, Suite 102

Ocoee, Florida 34761

Kenney Shipley, Executive Director

Florida Birth - Related Neurological

Injury Compensation Association

1435 Piedmont Drive, East, Suite 101

Post Office Box 14567

Tallahassee, Florida 32312

Michael S. Finazzo, M.D.

1921 Waldemere Street, No. 307

Sarasota, Florida 34239

Sarasota Memorial Hospital

1700 South Tamiami Trail

Sarasota, Florida 34239

Ms. Charlene Willoughby

Agency for Health Care Administration

Consumer Services Unit

Post Office Box 14000

Tallahassee, Florida 32308

Mark Casteel, General Counsel

Department of Insurance

The C apitol, Lower Level 26

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 proceeding s 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 b y 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 with in 30 days of rendition of the order to

be reviewed.