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FLOR CARRERAS, F/K/A MARIA THEODORA CARRERAS vs FLORIDA BIRTH-RELATED NEUROLOGICAL INJURY COMPENSATION ASSOCIATION, 93-003015N (1993)
Division of Administrative Hearings, Florida Filed:Miami, Florida Feb. 16, 1996 Number: 93-003015N Latest Update: Oct. 14, 1996

The Issue At issue in this proceeding is whether certain palatal pharyngeal muscle electrostimulation treatments the infant, Maria Carreras, received at the Pediatric Institute Szabadsaghey, Budapest, Hungary, in June 1993, were medically necessary and reasonable medical or habilitative and training expenses, as required by Section 766.31(1)(a), Florida Statutes, such that the expenses for treatment and related travel are recoverable under the Florida Birth- Related Injury Compensation Plan (the Plan). 1/

Findings Of Fact Background Maria Theodora Carreras (Maria) is the natural daughter of Flor Carreras (Flor), and was born February 5, 1989, at Mt. Sinai Hospital in Miami Beach, Florida. At birth, Maria suffered a "birth-related neurological injury," as that term is defined by Section 766.302(2), Florida Statutes, and she was accepted by respondent, Florida Birth-Related Neurological Injury Compensation Association (NICA) for coverage under the Florida Birth-Related Injury Compensation Plan (the Plan). Section 766.301, et seq., Florida Statutes. Consistent with Section 766.305(6), Florida Statutes, NICA's acceptance of the claim was approved by order of April 24, 1991, and NICA was directed to pay, inter alia, all future expenses as incurred in accordance with Section 766.31, Florida Statutes. The nature of Maria's injury Maria's injury at birth has rendered her permanently and substantially mentally and physically impaired. The significance of her impairment is evidenced by the medical examination of Dr. Michael Duchowny, a pediatric neurologist, who found, on January 17, 1992, at almost three years of age, that Maria evidenced spastic tetraparesis, cortical blindness, microcephaly and virtually no psychomotor development past the newborn period. Effectively, Maria functions at a precognitive level. Pertinent to the issue raised in this proceeding, one of the impairments from which Maria suffers is a swallowing disorder known as dysphagia. In Maria's case, that disorder is due to a spastic palatal pharyngeal muscle resulting, more likely than not, from the severe brain injury she suffered at birth. Such injury adversely affected the normal coordination between the nerves and the palatal pharyngeal muscle so as to prevent a normal swallowing reflex. Consequently, Maria is unable to ingest nutrition in a normal manner because of the threat of aspiration of the nutrients into the lungs, and the resultant danger of pneumonia, sepsis and potentially death. 3/ In infants suffering from swallowing disorders, tube feeding or a gastrostomy are medically indicated to avoid the aspiration of food during feeding. Fed in such manner, the threat of aspiration during feeding is eliminated; however, such techniques offer no protection against the threat of saliva aspiration, absent the swallowing reflex. 4/ In Maria's case, a gastrostomy was recommended within thirteen days of birth, but Flor, on the advice of Maria's pediatrician, Dr. Alberto Saenz Pacheco (Dr. Saenz), declined. 5/ Consequently, Maria was, and continues to be, tube fed. 6/ The early years At thirteen days of age, Maria, accompanied by her mother and Dr. Saenz, was flown to San Jose, Costa Rica, her mother's country of residence, and admitted to the National Costa Rican Children's Hospital. Following three days of observation, it was Dr. Saenz' opinion that Maria's condition was stable, and she was discharged to her mother's care. Since discharge, Maria has been attended by her mother, as well as by twenty-four-hour nursing care. At five weeks of age, Maria's pediatrician, Dr. Saenz, referred her to Moises Melendez for physical therapy. Mr. Melendez evaluated Maria's cerebral palsy, which he described as very severe or spastic, and established a regimen of physical therapy to avoid contractures and deformations, and to improve her physical condition. With regard to Maria's oral motor feeding and swallowing disorder, the therapy involved exercises to the oral musculature, such as the cheeks, lips and tongue, as well as exercise to address the pharyngeal musculature, by employing therapeutic strategies or exercises to other areas of the body which might be spastic, such as the shoulder girdle or the trunk, that would facilitate relaxation of that musculature. The goal of oral motor feeding or swallowing therapy is to ensure safe oral feeding, to habilitate swallowing or oral motor functions, and to inhibit abnormal movement and muscular patterns. 7/ Such goals are, however, often problematic because dysfunctional infants may or may not be receptive to habilitation, and, if receptive to habilitation the degree of improvement is variable. Maria has received the foregoing regimen of physical therapy, which has included the conventional oral therapies for her swallowing disorder, since she was approximately five weeks of age. Mr. Melendez has provided those services six days a week for one to one and one half hours a day, and he has trained Maria's nurses to provide similar services to relax her spasticity during the remaining hours of the day. On November 19, 1991, Maria's pediatrician, Dr. Saenz, prepared an update on her medical condition. That update provided, in pertinent part, as follows: This is an update on the present medical condition of Maria Theodora Carreras who has severe Cerebral Palsy secondary to perinatal birth asphyxia. General Condition: Maria continues to gain weight slowly. Her growth in length has been better. She continues to be fed exclusively by orogastric [sic] tube because she has very poor swallowing coordination and aspiration if fed by mouth . . . Neurological condition: she Her progress continues to be very poor although seems to have more awareness and some communication (verbal and non verbal) with her mother. She receives This antibiotic thorough fever daily physical therapy and occupational therapy. has prevented muscle contractures and has produced some improvement in head control . . . Prolonged febrile episodes: During the last five months Maria has had fever (between 38 oC and 39.5 oC) almost continuously. She has had cultures done which have been negative (urine, blood) and has had group A Beta Strep- tococcus in throat cultures. She has not had pneumonia by chest x rays as she did in the past. Most of the time I have found evidence of chronic upper air way infection, specially otitis media and sinusitis related to poor management of upper respiratory secretions. She has been on prophylaxis with amoxicillin and Badtrim with some improvement. Acute episodes have responded well to oral cephalosporins. She has been evaluated by an inmunologist [sic] who feels that she has not an immune deficiency and that her fever is caused by chronic aspiration. An E.N.T. consultation decided against any surgical procedure to improve local airway conditions, such as adenoidectomy and timpanic ventilation tubes. Because all of these problems I've recommended to Mrs. Carreras that Maria should have a very evaluation at a Center such as the John F. Kennedy Institute in Baltimore Maryland to define: Auditory and visual abilities and the need for any devices to improve sensorineural input. Evaluation by physical and occupational therapist to define further programs to improve what has been obtained so far. The questions of oral feedings, tube feeding or gastrostosmy should be addressed. Definition of the need for anticonvulsive medication. Definition of the cause or causes of the of unknown origin. I think the multidisciplinary team of the Kennedy Institute can be of great help to this child and her very supportive family. Whether Maria was ever evaluated by a multidisciplinary team at the John F. Kennedy Institute or other facility does not appear of record; however, the record does demonstrate that "chronic upper airway infection, specifically otitis media [ear infection] and sinusitis [infection of the sinus cavity]" noted by Dr. Saenz is not uncommon in infants of Maria's age, and was likely the cause, at that time, of her chronic fever. As to any serious lower respiratory tract infections, such as pneumonia, there is no medical documentation that would evidence that Maria suffered any such problems immediately preceding or at the time of the November 19, 1991 update; however, according to Dr. Saenz, Maria did suffer two mild episodes of lower respiratory tracheal infection which were treated at home and not noted in the medical records. The last such episode occurred at some unknown date in 1992, and Maria has suffered no lower respiratory infections since that time. While Maria was not shown to have suffered any serious lower respiratory tract infections after November 1991, and no minor cases after 1992, that is not to suggest that the threat of such an episode did not continue. Indeed, because of Maria's swallowing disorder, the threat of aspiration of saliva persisted with the consequent threat of infection. After 1992, Maria continued to experience periodic bouts of fever, which were, more likely than not, related to upper respiratory tract or bronchial infections caused by aspiration. The "Katona treatment" In or about early 1993, Flor was "faxed," by a friend in England, a magazine article that reported "a new treatment for dysphagia and sucking disorders," and identified Ferenc Katona, M.D., Ph.D. (Dr. Katona), of a facility known as the Pediatric Institute Szabadsaghey, Budapest, Hungary, as the originator of this "new treatment." Flor then inquired of personnel at the Costa Rican Embassy in Budapest, and was provided a copy of a publication entitled "Early Age," which is published, apparently, by ISM Ltd., a firm of marketing consultants in the United Kingdom, on behalf of the Pediatric Institute and Dr. Katona. Included within the publication were a number of short articles extolling the virtues of various habilitation techniques developed by the Institute, the availability of courses at the Institute for a fee, and, pertinent to this case, a one-page article on "Combating Sucking Disorders and Dysphagia." The article on "Combating Sucking Disorders and Dysphagia" stated, in pertinent part, the following: Cerebral palsy is often accompanied by severe impairment of feeding. The reason of this deficiency is a disturbed co-ordination of the cranial nerves innervating the muscles involved in the feeding process. The impairment may be intranuclear of extranuclear in the brainstem [sic]. nuclear In some diseases dysphagia is a result of a lesion, but in CP the main problem is the failing coordination of the nerves. In many such unfortunate infants, aspiration and regurgitation inhibits oral feeding and these babies are kept on tube feeding because of the risk of aspiration. In some cases even gastrostomy is indicated. These measures prohibit repeated pneumonias [sic], but stabilize the situation and certainly inhibit the development of normal feeding habits. The Department has introduced two new methods to perfect early diagnosis of dysphagia, and its causes, and a new method to activate coordinated control of the cranial nerves innervating the muscles operating in the sucking, swallowing, breathing process. One new method is the investigation of the rheobase of the palatopharyngeal muscles, with direct electrostimulation through thin and small electrodes. The normal threshold of the nerve points is 3-4 mAs, but this can be increased up to 10 in dysphagias. Another diagnostic method includes the pressure of the pharynx and the upper part of the oesophagus, sucking simultaneously with the registration of the bursts and the electrical activities of the oro- facial muscles. All these events are recorded on a polygraph. The comparison of the results of both examination processes produces information about the exact nature of the dysphagia, and the level of the impairment in the brain. If a proper indication is found direct electo- therapy of the palatopharyngeal muscles is introduced in the Department 2 - 3 times daily. This then is successively accompanied by special bottle feeding training. Usually this training is added to the end of each electrotherapy in about 1 - 2 weeks. Simultaneously tube feeding is diminished. The ultimate result of the treatment is the establishment of normal oral feeding and the complete omission of the tube feeding . . . . Essentially, the article describes two diagnostic procedures and a treatment modality for dysphagia which employ electricity as a means of stimulating the palatopharyngeal muscles "to activate coordinated control of the cranial nerves innervating the muscles operating in the sucking, swallowing, breathing process," and, ultimately, "the establishment of normal oral feeding." Flor shared the article with Mr. Melendez and Dr. Saenz, neither of whom had, despite their years of experience, ever heard of the Institute, Dr. Katona, or electro-stimulation of the palatopharyngeal muscles as a treatment for dysphagia. Electro-stimulation does, however, apparently have some utility in the field of physical therapy, although its specifics or relationship to the subject treatment was not reasonably explicated at hearing. Consequently, Flor sent Mr. Melendez to Budapest to further investigate the technique. Mr. Melendez spent approximately ten days in March of 1993 in Budapest, observing various treatment modalities at the Institute, including the electrostimulation of the palatopharyngeal muscles, as administered by Dr. Katona. Upon his return to Costa Rica, Mr. Melendez recommended to Flor that Maria be taken to Budapest for the Katona treatment. The predicate for such recommendation was Mr. Melendez's observation, as memorialized in a report of March 22, 1993, that while they had been working on Maria's swallowing disorder using conventional methods and "she had improve sucking and swallowing function, she [continued to] have problems with aspiration." Accordingly, based on his observation at the Institute and Dr. Katona's assurances that he could help Maria, Mr. Melendez recommended that Maria be sent to the Institute. 8/ Under date of April 26, 1993, Dr. Saenz prepared correspondence to Flor regarding her "intention" to take Maria to the Institute. That correspondence provided: I'm writing you in relation with your question regarding your intention to take your daughter Maria Theodora to be evaluated and treated by Dr. Katona in Budapest, Hungary. I've read the information that you sent me about Dr. Katona's time feeding aspiration work and the letter that was sent to you by Moises Melendez, your daughter's physical and accupational [sic] therapist. As you know I'm of the opinion that your daughter Maria Theodora should receive all the possible benefits of therapy directed to improve her neuromuscular status as well to build on any occupational achievements that she slowly obtains. One of Maria's biggest problems at the present is her inability to swallow which makes her difficult and predisposes her to repeated episodes and respiratory tract infections and if these can be further evaluated and treated by Dr. Katona I think it is very important to do so. Notably, it was not Dr. Saenz' idea to send Maria to the Institute, and his correspondence is devoid of any comment upon the efficacy of the Katona treatment. 9/ In June 1993, Flor Carreras and her daughter Maria, together with two nurses and Mr. Melendez, flew to Budapest, Hungary, to seek treatment for Maria from Dr. Katona at the Institute. Specifically, petitioners aver that the purpose of that trip was to secure electrotherapy treatment of Maria's palatal pharyngeal muscles to improve her sucking and swallowing function. The proof demonstrates, however, that in addition to electrotherapy, time was also spent by Dr. Katona on evaluations and therapies unrelated, or not shown to be related, to Maria's dysphagia and by Mr. Melendez and Flor learning a variety of therapies also unrelated, or not shown to be related, to Maria's swallowing disorder. Regarding the evaluations and treatments Maria received, as well as the training Mr. Melendez and Flor received, Dr. Katona's report observes: Summary: Maria TeodoraCarreras [sic] suffers from the consequences of a brain injury. Only tube feeding was administered owing to dysphagia. The frequent opistotonic [sic] fits inhibited the development of active sensorimotor behavior. Spastic diplegia [sic] is present in a very serious form. While the extremities are in a spastic state the axial muscle are severely hypotonic. This combination absolutely prohibited all forms motor Activity. Even the slightest change of body position was limited. The child comfort caretaking activate has no positive motivation to contact her environ- ment and is motivated merely by the voice of the mother and by her tactile contact. Therapeutic possibilities: Dysphagia: The present state of alimentation through tube feeding may be altered. This may give more to the mother and better possibilities for activities. The limit of these possibilities is restricted. Dysphagia may be diminished by daily electrotherapy. The levator muscle and the palatopharyngeal muscles are to be stimulated 3 times a day for 10-15 min. If the stimuli complex deglutative [sic] movements in the muscles then drops of tee [sic] can be given simultaneously with the contraction of the muscles in response to the electric stimuli. If this state can be reached bottle amount long- relative environmen body than each stimulation series (10-15 min) may be immediately followed by a cautious attempt of feeding. Naturally care should be taken to avoid any aspiration. If bottle feeding is successful (5-10 gs at the beginning!) the amount of post stimulational [sic] alimentation can be decreased gradually! In this case the oraly [sic] given of nutriments should be deducted from the amount given through the tube. (At the initial state of the therapy it must [be] kept in mind that the time previous experience with tube feeding a life saving procedure in this case - has inhibited the development of oral contact with the [sic] and has produced indirectly a refusal of everything coming transoraly [sic], including nutriments and fluids). Sensorimotor therapy: The first trial to improve body position and mobility may be phocused [sic] to the activation of the axial muscles. Without the stabilization of the head on the top of the activated receptor position can training. may muscles. maternal- no achievement can be expected in body posture, mobilisation [sic] of the arm, or better visual and auditive contact with the environment. The therapeutical training of the muscles affecting the function of the vertebrobasilar articulation may be possible since head arisal [sic] was several times by acting on the semicircular system and the vestibular system through special body postures. The systematic training of these stimulus positions may be recommended for 5 weeks to see wether [sic] an improvement of head can be reached. Also the erection of the trunk be trained by the appropriate therapeutical All these therapeutical trainings simultaneously serve to diminish the frequency and vigor of the opistotonic [sic] reactions. Rotatory activity be initiated by acting upon the semicircular and vestibular system. The therapeutical training positions and activities that serve to accomplish these effects and the training procedures as well have been shown to the mother, and to the physiotherapist of the child. They have had a training in our department and were introduced in the theoretical aspects as well. The mother has had occasion to make video movies from all the clinical procedures including the electrostimulation of the palatopharyngeal * * * In summary all the suggested treatments are only to achieve eventualy [sic] better comfort to family care and to give a somewhat better possibility to mobilise [sic] the child. On the other hand if alimentation can be changed into regular oral feeding, be for and sitting position can also be achieved this may a possible advantage to Maria and may be a basis further minuscule improvement. For the services rendered at the Institute, Dr. Katona billed $900.00 for the following functions: Diagnostic examination of Maria Teodora [sic] Carreras (from 1-11. 06. 1993.) Developmental neurologic examination of the vestibular functions extrapyra-idal motor control sensory system postural activities locomotor functions EEG Evoked brainstem [sic] responses Developmental psychology assessment Palatopharymgeal [sic] electric stimulations (6 times) Sensorimotor investiatin (12 times) For the eleven days the Carreras' party spent in Budapest, petitioners seek to recover the $900.00 billed by Dr. Katona; an air fare bill of $4,659.61 for Flor, Maria and the two nurses; and, a hotel bill of $5,600.00 for the accommodations of Flor, Maria and the two nurses. No reimbursement is sought for the expenses incurred, if any, as a consequence of Mr. Melendez' presence on the trip. 10/ [See, Tr. page 204, and petitioners' proposed final order paragraph 87]. Since the Katona treatment After the Carreras' return home from the Institute, Mr. Melendez integrated the electrical stimulation of Maria's palatopharyngeal muscle, according to the Katona method, into his physical therapy program for Maria. As before, Mr. Melendez worked with Maria six days a week, dedicating one hour a day to conventional physical therapy, and an additional one half hour of palatopharyngeal and facial stimulation, consisting of the continued use of conventional physical therapies and the addition of electrical stimulation. Approximately one to one and one half months after their return from the Institute, Maria's condition started to show slow improvement in that she was showing some sucking reflex and was making some movements toward, although not complete, a lip seal. She also began evidencing less aspiration and fewer recurrent fevers, a stronger cough reflex, less drooling, and less wheezing. Approximately one and one half to two months later she was encouraged to swallow small pieces of ice, of the approximate size of a small bean, and about a month to a month and a half later progressed to swallowing a few pieces of small soft fruit, such as peaches, banana and mango. Finally, in March 1994, Maria was able to start taking water from a bottle, and has progressed to being able to take approximately one ounce at any given time; however, she still needs assistance to help her complete a lip seal, and continues to receive all her nourishment through tube feeding. Concerning the improvements Maria has made, Flor and Mr. Melendez attribute such improvement to the electrical stimulation therapy she has received to her palatopharyngeal muscle. Considering the lack of any compelling proof regarding the medical value of the Katona treatment, discussed infra, any such conclusion is, at best, speculative. Indeed, given the circumstances, it is as likely that Maria's improvement is a consequence of the conventional physical therapy she has received since shortly after birth and the natural maturation process she has undergone. The efficacy of the Katona treatment Having assessed the proof concerning the efficacy or medical value of the Katona treatment or, more pointedly, the lack of such proof, it must be concluded that the record fails to demonstrate by competent and credible proof that the Katona treatment is of any medical value and, therefore, fails to demonstrate that Maria's receipt of such treatment was "medically necessary and reasonable" within the meaning of Section 766.31, Florida Statutes. As to Dr. Katona himself, the only competent proof of record demonstrates that he is a medical doctor and holds a Ph.D. The record is devoid of any competent proof regarding the field in which his Ph.D. is held, his training or experience, and his special competence, if any, in the field of electrostimulation. 11/ Indeed, Dr. Katona was unknown to the medical experts who testified in these proceedings, as was the Institute, and, obviously, no opinions regarding his reputation were offered. As with the lack of any compelling proof regarding Dr. Katona's background or experience, the record is likewise devoid of any competent or compelling proof regarding the efficacy or medical value of the Katona treatment for combating sucking disorders and dysphagia through electrotherapy of the palatopharyngeal muscles. In this regard, the record failings include an absence of competent proof regarding the protocols of the two diagnostic procedures described in the "Early Age" article, and no proof regarding their effectiveness as diagnostic procedures. Most importantly, the record further evidences a lack of competent proof regarding the protocol for Katona's treatment modality, which employs electrostimulation, and absolutely no proof regarding Katona's success or failure experience with the treatment, and therefore no proof that use of the treatment modality has been significant enough to generate any meaningful insight into its value or that its use is reasonably associated with a positive outcome. In sum, there is no persuasive or competent proof of record from which it could be reasonably concluded that the Katona treatment is of any medical value in the treatment of sucking disorders and dysphagia, or that Maria, under the Katona diagnostic procedures (which were not explicated), was an appropriate candidate for treatment. In reaching the foregoing conclusion, the proof offered regarding Maria's progressive improvement since she began electrostimulation therapy and the testimony of petitioners' experts suggesting that there is a theoretical basis to support such treatment, has not been overlooked. However, for the reasons that follow, such proof is not compelling. First, as regards the improvements Maria has exhibited since starting the treatment, it is as likely, considering the proof in this case, if not more likely, considering the absence of any direct or substantial proof regarding the efficacy of the Katona treatment, that such improvements were occasioned through the traditional therapies that were employed to address her swallowing disorder, as opposed to the Katona treatment. Indeed, traditional massage stimulation and sensory stimulation is specifically administered to restore, habilitate and rehabilitate swallowing and oral motor functions that have been disordered because of neurological damage. It is also designed to inhabit abnormal movement patterns and to encourage normal and functional movement patterns in the oral and pharyngeal muscles with the goal of encouraging swallowing and the prevention of aspiration. Notably, Maria experienced improvement in these areas prior to the Katona treatment, and there is no competent proof of record that the Katona treatment has even improved the swallowing disorder of a single infant. Under the circumstances, Maria's improvement, standing alone, does not offer compelling proof that the Katona treatment is of any value. 12/ Finally, the proof offered by petitioners, through their experts, was likewise not compelling support for the efficacy of the Katona treatment. In this regard, it is observed that Dr. Noble David reviewed the Katona treatment, as described in "Early Age," as well as a few other articles on other subjects attributed to Dr. Katona, and particularly reference to a treatment modality referred to as "Transurethral electrical bladder stimulation," the origination of which was attributed to Dr. Katona. Based on that review, it was his "understanding" that Katona's rationale was the use of electrical sensory input to "teach, in a sense or habituate the brain cells up in the brain that are remaining there, that are capable of doing this chore, to do it more efficiently and to obey that stimulation." Dr. David then concluded that the Katona theory is a reasonable way to approach the problem. Admittedly, however, Dr. David had not previously known of Dr. Katona, the Institute, or the treatment, had never used or followed a patient that had used the treatment, and had no information, apart from the Early Age article, bearing on the efficacy or effectiveness of the treatment. Moreover, with regard to the treatment modality known as "transurethral electrical bladder stimulation," it is observed that its effectiveness is subject to serious question, based on the only authoritative work petitioners offered. [Petitioners' exhibit 3]. According to that article, the authors' initial evaluation of the modality failed to substantiate Katona's claim that its use would allow patients to void voluntarily. Indeed, as observed by Dr. Michael Duchowny, and agreed to by Dr. David, the whole history of peripheral stimulation to counteract the effect of brain damage as recounted in the neurological literature has been one of disappointment. [Tr. pages 31-32, and 138- 139]. Petitioners also called Pamela Clarke, a special language pathologist who serves as coordinator for the feeding and swallowing disorder team at Miami Children's Hospital, and who treats profoundly impaired infants. Ms. Clarke's knowledge concerning the Katona treatment was also limited to the article that appeared in Early Age. Based on that article, Ms. Clarke observed that the philosophy behind the Katona treatment, the stimulation of the palatopharyngeal musculature, appeared to be similar to the philosophy or goal her team seeks to achieve through traditional or manual stimulation of the muscle. Notably, Ms. Clarke, as with Dr. David, had not previously known of Dr. Katona, the Institute, or the treatment, had never used electrical stimulation of the pharyngeal muscles in her practice, and had no information, apart from the Early Age article, bearing on the treatment or its efficacy. In sum, Ms. Clarke was unable to render any opinion regarding the effectiveness of the Katona treatment. Finally, there is of record the observations and opinions rendered by Dr. Saenz and Mr. Melendez which were offered in support of the Katona treatment. In this regard, Dr. Saenz observed that the Katona method made sense in a theoretical way for two reasons. First, that stimulation of muscles that had not been used might help them recover some of their function and, second, that electrical input or stimulation to the brain may help to develop associations with other areas of the brain to compensate for the areas of the brain that have been lost, which ordinarily controlled the function. As for Mr. Melendez, he observed that the Katona treatment made theoretical sense to him also, because physical therapists use electrical stimulation in other areas of physical medicine and, therefore, he was interested in Dr. Katona's new approach to addressing swallowing disorders Again, while Dr. Saenz observed that the Dr. Katona's treatment made sense in a theoretical way, neither his testimony nor the testimony of Mr. Melendez is persuasive proof of the actual efficacy of the Katona treatment. Simply because electrostimulation may enjoy success, although its frequency, scope or duration is not of record, in other areas of physical therapy, is not persuasive proof that the Katona treatment offers similar benefits. Again, there is no compelling proof of record which demonstrates any experience with the Katona method, apart from Maria, no proof of its acceptance by practitioners as being associated with a positive outcome, and therefore no persuasive proof that it is of any medical value. 13/

Florida Laws (6) 120.68766.301766.302766.305766.31766.311
# 3
CHRISTINE LOWREY AND JESSE LOWREY AS PARENTS AND NATURAL GUARDIANS OF OLIVIA LOWREY, A MINOR vs FLORIDA BIRTH-RELATED NEUROLOGICAL INJURY COMPENSATION ASSOCIATION, 18-004150N (2018)
Division of Administrative Hearings, Florida Filed:St. Petersburg, Florida Aug. 06, 2018 Number: 18-004150N Latest Update: Apr. 12, 2019

The Issue Whether Petitioners’ claim for compensation is time- barred pursuant to section 766.313, Florida Statutes. Whether Olivia Lowrey (Olivia), the minor child, has suffered a birth-related neurological injury as defined in section 766.302(2), compensable by the Florida Birth-Related Neurological Injury Compensation Plan (Plan).

Findings Of Fact Olivia was born at St. Joseph’s on November 23, 2010. The attending physician was Lorraine Bevilacqua, M.D., who was, at the time, a participating physician with the NICA Plan. Olivia weighed 2,820 grams at birth, or 6 pounds, 3.5 ounces. The medical records indicate that Ms. Lowrey was scheduled for a Cesarean section when she presented to the hospital in early labor. Medical staff prepped her for the Cesarean section upon arrival. According to the operative note, the Cesarean section delivery was complicated by existing adhesions, and discovery of an asymptomatic uterine rupture. The infant, which was noted to be a “viable female with Apgars of 4 and 9,” was delivered with the assistance of vacuum suction, and “suctioned. The cord was doubly clamped and cut, and the infant was taken to the awaiting nursing staff where the infant was easily resuscitated and responded well.” The Nurses Delivery Record indicates that at one minute, Olivia’s Apgar score2/ indicated she had an appropriate heart rate (2); slow, irregular respiratory effort (1); was limp (0); displayed a grimace (1); and was blue or pale in color (0), with a total score of four. At five minutes, her heart rate was fine (2); she exhibited a good cry in terms of respiration (2); had active motion (2); was crying (2), but still had blue extremities (1), for a total Apgar score of 9. Dr. Willis reviewed all of the medical records, both those that were supplied as exhibits to the Motion and those that were not. He indicated in his report that prior to delivery, the fetal heart rate monitor did not suggest fetal distress. The newborn evaluation noted hemorrhage in the left eye and icterus (jaundice). Routine care was initiated, and the records indicate no neonatal complications. There was no seizure activity during the newborn hospital stay, and no EEG or head imaging studies were performed at that time. Olivia’s parents assert that during delivery, the umbilical cord was wrapped around Olivia’s neck twice, despite the fact that the records do not mention this. They have attempted to get the hospital to correct the medical record with respect to this issue, but to no avail. Olivia’s parents are understandably distressed that the medical records do not reflect what they remember happening at Olivia’s birth, but what gave rise to the apparent discrepancies in the records is beyond the scope of this proceeding. Even if it is assumed, for the sake of this Order, that Mr. Lowrey witnessed the cord’s presence around Olivia’s neck, that event, without more, does not establish that the event led to a birth-related neurologic injury as that term is defined in section 766.302(2). Dr. Willis also noted that a CT scan of the brain was performed when Olivia was approximately six months old, and was “essential [sic] normal, describing only benign macronania.” He also noted that there was no documented fetal distress prior to delivery, and the baby did not suffer multi-system organ failure, which, according to Dr. Willis, is a common finding with birth-related oxygen deprivation. He opined, and his opinion is credited, that there was no apparent obstetrical event that resulted in oxygen deprivation or mechanical trauma to the brain or spinal cord during labor, delivery, or the immediate postdelivery period. Petitioners did not provide the expert opinion of a medical professional to rebut Dr. Willis’s opinion. Olivia is now approximately eight and a half years old. She has been diagnosed with ADHD, OCD, anxiety disorder, sleep disorder, and autism, and suffers from some sensory issues. The medical records indicate that she suffered mild developmental delays, and she has received therapy for a variety of concerns. However, the evidence does not demonstrate that as a result of a birth-related event, Olivia has suffered permanent and substantial physical and mental impairment. The Petition simply alleged that Olivia Lowrey “suffered brain damage as a result of a difficult birth.” There is no mention of what type of impairment resulted. NICA served Petitioners with interrogatories in response to their claim. Interrogatory number 7 asks: “Do you contend that OLIVIA LOWREY suffered mechanical injury during the course of labor, delivery or in the immediate post-delivery period? If so, please state whether you contend that such mechanical injury was suffered during labor, delivery, or in the immediate post-delivery period.” Petitioners answered, “My opinion is YES. We were never informed of mechanical vacuum assist during labor.” While the answer identifies a possible injury as occurring during labor, there is no indication provided (nor other evidence presented) to establish just what injury, if any, was caused by the use of the vacuum assist. Interrogatory number 9 asks, “Do you contend that OLIVIA LOWREY suffers from a permanent and substantial mental impairment?” Petitioners answer states that as a baby, Olivia was diagnosed as developmentally delayed, and that after multiple tests, she “has the following mental impairments: Autism, ADHD, sleep disorder, developmentally delayed, macrocephaly, encephalopathy.” Interrogatory number 11 asks, “Do you contend that OLIVIA LOWREY suffers from a permanent and substantial physical impairment? Petitioners’ response states, “[n]o, not physical - - mental, social, emotional, permanent and substantial deficits!” Petitioners provided a letter from a psychiatrist who cares for Olivia. Jeffrey Alvaro, M.D., a board-certified child, adolescent, and adult psychiatrist at Johns Hopkins All Children’s Hospital, authored the letter dated November 2, 2018, apparently for the purpose of establishing an IEP (individual education plan) for Olivia. Dr. Alvaro states: Olivia is a patient under my care at the Pediatric Psychiatry Clinic at Johns Hopkins All Children’s Hospital. She has been diagnosed with Autism Spectrum Disorder, ADHD, and Unspecified Anxiety Disorder. She has significant problems with inattention, impulsivity, hyperactivity, social skills, and anxiety that directly impair her learning process. Her diagnosis of Autism has been confirmed by ADOS testing. Though she is gifted, her other symptoms still cause significant issues in the classroom. She would benefit from extra time with testing, preferential seating, extra time at lunch, and extra breaks from class— especially when she is anxious. Please consider any other accommodations that are appropriate to help her manage the above symptoms. While Dr. Alvaro’s letter describes a litany of mental or cognitive impairments from which Olivia suffers, it does not describe any physical impairments, much less any physical impairments that rise to the level of being permanent and substantial. Petitioners also supplied a psychological evaluation from the University of South Florida, based upon testing dates of February 27, May 29, and June 12, 2018. The psychological evaluation notes that Olivia is in good health with no major medical concerns. It would have been helpful to have an opinion from either party as to whether Olivia’s issues rise to the level of a permanent and substantial mental and physical impairment. However, it appears from NICA’s pleadings that Olivia was scheduled for an evaluation, but did not appear for her appointment. The discovery responses received from Petitioners indicate that there is no physical impairment claimed. Petitioners have not provided an opinion from a physician (although they have provided records indicating a variety of medical appointments she has had) as to her current physical condition, or an opinion as to whether she suffers from permanent and substantial physical and mental impairments. In sum, NICA’s Motion and the attached exhibits demonstrate that there is no birth-related neurological injury resulting in permanent and substantial mental and physical impairments. The information provided by Petitioners in response to the motion does not create a dispute of material fact with respect to this issue.

Florida Laws (12) 766.301766.302766.303766.304766.305766.306766.309766.31766.311766.313766.31695.11 Florida Administrative Code (1) 28-106.204 DOAH Case (1) 18-4150N
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SHEENA PUGH, ON BEHALF OF AND AS PARENT AND NATURAL GUARDIAN OF REGINA SINGLETON, A MINOR vs FLORIDA BIRTH-RELATED NEUROLOGICAL INJURY COMPENSATION ASSOCIATION, 21-000786N (2021)
Division of Administrative Hearings, Florida Filed:Apopka, Florida Feb. 22, 2021 Number: 21-000786N Latest Update: Sep. 29, 2024

The Issue The issues to be determined are whether the infant, Regina Singleton (Regina), suffered a birth-related neurological injury as that term is defined by section 766.302, Florida Statutes (2014), and whether Petitioner’s claim for compensation is barred by the application of section 766.313.

Findings Of Fact Regina was born on October 18, 2014, at Winnie Palmer Hospital. The Motion for Summary Final Order indicates that Regina’s medical records are attached to the Motion for Entry of Protective Order Regarding Confidential Documents Related to Petitioner’s Medical Records. There are no medical records attached to the Motion for Entry of Protective Order. Similarly, the Motion for Entry of Protective Order speaks in terms of confidential documents attached to the Motion for Summary Final Order. The only document attached is the Birth Certificate for Regina, which is also attached to the Petition. Notwithstanding that no medical records referenced in the Motion for Summary Final Order are actually attached, there is sufficient information in the birth certificate, which is provided and is already of record, to support the Motion for Summary Final Order. The birth certificate indicates that the infant’s weight at birth was five pounds, seven ounces, which is less than 2,500 grams. Petitioner has not disputed that Regina’s birth weight was below the 2,500-gram threshold established in section 766.302(2) for eligibility for NICA benefits.

Florida Laws (13) 120.569766.301766.302766.303766.304766.305766.306766.309766.31766.311766.313766.31695.11 DOAH Case (1) 21-0786N
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AIZA P. VELAZQUEZ AND ENEMIAS VELAZQUEZ, INDIVIDUALLY AND ON BEHALF OF BENTLEY X. VELAZQUEZ, A MINOR vs FLORIDA BIRTH-RELATED NEUROLOGICAL INJURY COMPENSATION ASSOCIATION, 15-000420N (2015)
Division of Administrative Hearings, Florida Filed:Winter Garden, Florida Jan. 22, 2015 Number: 15-000420N Latest Update: Apr. 30, 2015

Findings Of Fact Bentley X. Velazquez was born on September 19, 2009, at Health Central in Ocoee, Florida. Donald Willis, M.D. (Dr. Willis), was requested by NICA to review the medical records for Bentley. In a report dated March 9, 2015, Dr. Willis described his findings in pertinent part as follows: Fetal heart rate (FHR) monitor tracing during labor was reviewed. The FHR pattern was reactive and did not suggest fetal distress. Delivery was by spontaneous vaginal birth. Birth weight was 3,327 grams (7 lbs 5 oz’s). There was a loose nuchal cord. The newborn was not depressed. Apgar scores were 9/10. No resuscitation was required. Newborn exam noted “ear shape tilt down.” Otherwise, newborn exam was normal. The baby was not in distress. Newborn hospital course was benign. Discharge home was on DOL 2. Right-sided weakness was noted at 6 months of age. MRI showed an old cerebral infarct. Coagulation evaluation was negative. The child was subsequently diagnosed with spastic hemiplegia and developmental delay. Follow up MRI’s showed remote insult of left middle cerebral artery and resulting encephalomalacia. In summary, labor and delivery were apparently without complications. Delivery was by spontaneous vaginal birth. The baby was not depressed. Apgar scores were 9/10. The newborn hospital course was benign with discharge home on DOL 2. The child was found to have a cerebral infarct at 6 months of age. The infarct does not appear to be related to a hypoxic event or trauma during labor, delivery or the immediate post-delivery period. A review of the file reveals that no contrary evidence was presented to dispute Dr. Willis’ finding that while Bentley was found to have a cerebral infarct at 6 months of age, Bentley’s injuries were not related to a hypoxic event or trauma during labor, delivery or the immediate post-delivery period. Dr. Willis’ opinion is credited. The Petition was filed on January 20, 2015, which is more than five years after Bentley’s birth.

Florida Laws (8) 766.301766.302766.303766.305766.309766.311766.313766.316
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