Findings Of Fact At all times pertinent to the allegations herein, the Petitioner, Board of Medicine, was the state agency in Florida charged with the licensing and regulation of physicians in this state. Respondent, Dr. Lewis Sidney Wolf, was at all times pertinent licensed as a physician in Florida. Dr. Wolf took his medical degree at the university of Bologna, in Italy, and thereafter did his internship and residency training at hospitals in New York. He has been in the private practice of obstetrics and gynecology since 1977 and though not Board certified, has limited Board eligibility. Upon completion of the required continuing medical education courses he will be eligible to sit for the Board examination. He was employed as a physician at the Aware Woman's Medical Center, (Center), an abortion clinic in Port St. Lucie, Florida, from May, 1987 to October 8, 1990. During that time he had no responsibility for administration or the business affairs of the Center. On January 5, 1990, he saw L. S., (Patient 1), a 19 year old rather tall woman on whom he had done a previous abortion, who had come in for termination of another pregnancy. He recalls her as being normal both mentally and physically. His physical examination of the patient consisted of listening to her heart and lungs and doing a bi-manular pelvic examination. This includes placing one hand in the patient's vagina to feel the cervix and the other hand on the patient's abdomen at the top of the uterus. By doing this, the physician can see how big the uterus is and feel for any abnormality caused by pregnancy or fibroids. Respondent's examination of this patient showed she had a regular, smooth and symmetrical, if large, uterus. Since other tests had shown she was pregnant, he decided to terminate it at her request. Respondent's initial examination caused him to estimate the fetus size was larger than 9 weeks. He therefore suggested the patient be given a sonogram to determine with some accuracy how big it was. However, since the patient was so tall, and this can be deceiving as to uterus size, and because his assistant, Candace Dye, the clinic administrator who, incidentally, had no medical training, disagreed with him, and because the procedure was already scheduled and a sonogram, which had to be done outside the office, would be costly to the patient and would interfere with the scheduled procedure, he checked the patient again and concluded the fetus size was only 9 weeks. Since he felt that maybe the untrained layman was correct and since the termination procedure was the same up to 14 weeks as it was at 9 weeks, he assumed responsibility and decided to go ahead with the termination using a dilation and curettage. In this procedure, metal rods of increasing size are inserted into the cervical opening to dilate it after which a plastic tube with a hole on the side, (a cannula) is inserted into the uterus to remove the fetus by means of a vacuum aspirator, (suction). This procedure is not generally used to terminate a pregnancy of longer than 14 weeks. Page 10 of Petitioner's Exhibit 2, the patient records from the Center, reflect that Respondent's initial estimate of fetal size, as recorded by the nurse, was greater than 12 weeks and the Respondent at first ordered a size 12 cannula. However, after the cervix was dilated, Respondent ordered a 14 cannula because during dilation he felt the fetus was larger than anticipated. After the first aspiration, Respondent felt there was still some tissue left in the uterus and inserted the cannula again to get it. At this point, Respondent noticed some yellow fatty material in the aspirator which he believed came from the omentum, the outside of the uterus, and he believed that the cannula head had gone through the side of the uterus at the site of a scar from a previous caesarian section, (the patient had had two previous caesarian sections). This is the place where, according to Respondent, most perforations occur due to the weakening of the uterus as a result of those procedures. In the interim period between the removal of the cannula after the first insertion and the second insertion, because he could not get all the tissue out during that first insertion, Respondent used a placenta forceps to get the bony part of the fetus, (an arm), which would not go through the cannula. He then used the cannula the second time and cannot be sure if it was the forceps or the second application of the cannula that caused the perforation. In any case, when he realized that a perforation had occurred, he packed the uterus with gauze and called 911 to have the patient taken to the hospital. She subsequently recovered but lost one tube. Patient 2, a 41 year old female, reporting two prior deliveries, came to the Respondent for a pregnancy termination on October 28, 1989. At the time, she seemed quite nonchalant about the whole process. She reported having a fibroid uterus and claimed to have had a recent sonogram which showed a "VBD" of 5.1. The term "VBD" is incorrect for use in connection with a sonogram. The appropriate initials are "BPD", bi-parietal diameter, and a BPD of 5.1 correlates to a fetus age of in excess of 21.5 weeks. The patient also indicated that she had only had sexual relations twice in several years, the last of which was consistent with a pregnancy of far less duration that 20 weeks. Respondent did a bi-manular examination and estimated from that a gestational age of the fetus of 20 weeks. However, the patient's forms showed a sonogram had been done on October 21, 1989 and the uterus size given as a result thereof was 9. Respondent claims his estimate of 20 was for the uterus size, not the fetus size, and this is not inconsistent with the diagnosis of fibroid uterus which could, of itself, considerably increase the size of the uterus. In addition, Respondent claims his examination showed the uterus to be firm and in pregnancy, the uterus generally gets soft. Based on all the above, and given the fact that the Patient could not recall where the sonogram had been done, and the fact that she seemed reliable to him, Respondent concluded that the pregnancy was of only 9 weeks duration and agreed to terminate it by dilation and curettage. His description of the patient as reliable is not consistent with his other comments regarding her at the hearing wherein he described her as inconsistent and mixed up. In retrospect, at the hearing, he admitted he now realizes she was lying to him. As Respondent was preparing the patient for the procedure, he noted on her chart that the sonogram showed 5.1. This figure represents the diameter through the head of the fetus. He did not have a chart handy from which to extrapolate the sonogram figure to a fetal age. He asked his assistant, Michelle Trent Wimble to check it. She left the room and when she came back reportedly stated, "It's OK - it's only 11 weeks." In reality, Ms. Wimble did not look at the correct chart and the information she gave to the Respondent was incorrect. He did not verify it. In the termination, Respondent started with a size 12 cannula. Once the vacuum was initiated with that cannula, he shifted to a 14 and then requested a placenta forceps. He changed the size because, he asserts that once the patient was dilated, he realized the fetus was larger than he had anticipated and needed the larger size. Also, when he saw the amniotic sac he knew the pregnancy was further along than 11 weeks but because he was committed and could not let the patient go home like that, he had to continue. He broke the sac and tried to vacuum with a 16 mm cannula, the largest made, but was still unsuccessful. He then tried the forceps. When he saw the umbilical cord had prolapsed, and had removed a hand from the fetus, he knew it was much older than anticipated. Since it was obviously beyond the 14 weeks menstrual limit the Center set for abortions there, he called 911 to have the patient taken to the hospital for completion. Respondent has specialized in abortions not only for his 3 years at the Center, but at other clinics in New York, Tampa and Ft. Myers, where he filled in for another physician whose license was under attack. He has done over 5,000 abortions and claims to have experienced complications in only 4 of them. Each of these involved perforations of the uterus. According to Ms. Dye, who worked with Respondent for the three years he was at the Center, his problem rate was low. A perforation may occur as the result several different factors such as a tilting of the uterus or frequent prior pregnancies which weaken or soften the wall of the uterus. A perforation is also more likely in a woman who has had one or more caesarian sections. It is not necessarily due to negligence on the part of the physician though it may be. According to Respondent, most often it is not negligence but more a complication which occurs because of the anatomical arrangement of the pelvic organs. With regard to Patient 1, Respondent feels he did nothing wrong. Her records show that from her last menstrual period she would be 11 weeks pregnant based on her last period date of November 1, 1989. Also, from her history sheet he notes 2 reasons for her being a higher risk patient. She had had two caesareans sections and one prior abortion. She was 19 years old and had had 5 pregnancies. Therefore, he claims, her uterus had not had time to rest and could easily be perforated. In addition, as a result of his examination, he was quite comfortable with a 9 weeks fetal determination. Though she might have been slightly over that she was still within the limits for a suction abortion. He is also comfortable having done the bi-manual examination which he feels is generally reliable. Factors such as a tall patient can throw it off, however, he claims. With regard to Patient 1, Respondent claims there was nothing about her to alert him to danger. It is not usual to change cannulas in mid- procedure. It is done from time to time, especially in the first pregnancies of young women whose cervix are hard to dilate. He also claims it is not unusual to over or under estimate a pregnancy by 2 weeks. It is impossible to tell exactly how many weeks a patient is pregnant. Respondent admits a patient history sheet is important and it is important that the patient give honest information for it. Erroneous information from any source, if relied on by the physician, can result in injury to the patient. Patient 2 was a 41 year old woman at the time he saw her. This fact makes her a high risk patient for carrying the fetus to term. From the last menstrual period she reported, she would be 12 weeks pregnant. The sonogram results as passed to the Respondent was consistent with 11 weeks of pregnancy and with the menstrual history. Assuming her sexual history were correct, she could be no more than 16 weeks pregnant. Because the patient referred to a "VBD", similar in sound to "BPD", the correct term, Respondent considers it was reasonable for him to believe she had had a sonogram. Here, however, the Respondent stated at one point that at that time he did not believe her and if that is the case, it was improper for him to do the procedure on a patient who he did not believe had given him a correct history. Further, when a patient shows a history of prior pregnancies or caesarian sections, admittedly that patient is at a higher risk of perforation and the doctor should be more cautions and more prepared than otherwise. Respondent's performance in the two cases at issue here was reviewed by Dr. Edward J. Zelnick, himself an expert in the field of obstetrics and gynecology, who has done numerous pregnancy terminations in the past. His review consisted of an examination of the clinic and hospital records of both patients. In order to safely and properly terminate a pregnancy, it is necessary for the physician to know the size of the fetus. This can be determined by the history taken from the patient, by physical examination of the patient, including both palpation and bi-manual manipulation, and by sonogram. In the case of patient 1, Respondent performed a suction curettage. Before doing so, he accomplished a bi-manular examination and determined the fetus was 9 weeks of age. The records reflect that initially an ultrasound, (sonogram), was requested, but that order was rescinded. In the suction curettage the cervix is dilated with metal rods of increasing diameter and the cannula is then inserted to remove the fetus by suction. The size of the fetus determines the size of the suction tube to be used. Here, Respondent selected an 11 cannula which can be used generally with fetuses from 9 to 11 weeks of age. The records reflect that little tissue was obtained through the use of the cannula, so Respondent asked for and used a larger one. After the size of the cannula was increased, a placental forceps was used to remove a fetal extremity and a portion of the oventum, (a portion of fact attached to the intestine not generally found in the uterus). The presence of the oventum indicates that the wall of the uterus was perforated. Dr. Zelnick feels this perforation could have been avoided if more care had been utilized in the determination of the fetal size. There appeared to be a discrepancy between the appearance and the actual size and duration of the fetus. If the size was, as here, underestimated, the larger actual fetus prevented the doctor from getting the amount of tissue he expected. This could lead him to go deeper or in a different direction that she should go to get tissue. In light of this, Dr. Zelnick opined that the level of care rendered to Patient 1 by the Respondent was below standard because the final outcome and the manner of performance is not properly reflected in the records. Also, the wrong size instruments were used. Most important, however, is the failure to properly determine the size of the fetus. If the doctor is unsure of the fetal size, he should take further steps, through ultrasound or otherwise, to be more specific. Here, in Zelnick's opinion, the perforation occurred when the Respondent went into the uterus with the placental forceps. Once the perforation was noted, Respondent properly had the patient taken to the hospital where her abdomen was opened and her right fallopian tube and ovary were removed. In addition, her uterus was repaired. All this resulted in her being exposed to risk due to anesthesia, infection and hemorrhage. In addition, she unnecessarily lost her tube and ovary due to the bleeding caused by the perforation. Since she now has only one tube and ovary, there is a possible diminishment in future fertility, but there is some doubt as to that happening. As to Patient 2, according to Dr. Zelnick, the Respondent established she was 9 weeks pregnant. The records show the result of the bi-manual examination showed 9 weeks, but they also reflect the patient had a sonogram and to Dr. Zelnick, it is unclear because the record of the sonogram showed a 5.1 BPD which is consistent with a 20 - 22 week pregnancy. In addition, the patient gave a history of only 2 sexual relations prior to the visit which is inconsistent with the other findings since the last intercourse would have been to 15 weeks prior to the visit which would not fit with a 9 week fetus finding. The nurse's note on the patient records indicate the only information the patient could give was that the sonogram showed a 5.1 LMP [sic]. In this case, Respondent also did a suction curettage initially using an 11 cannula. He then requested a 12 cannula and almost immediately went to a 14 which he then increased to a 16 which would be used for a 14 - 16 week fetus. When he failed to get an adequate tissue return, he used a placental forceps and saw a fetal extremity and umbilical cord. When he saw this, he realized the pregnancy was further advanced than expected and stopped the procedure and called for emergency services. This patient was also given an injection of Petosin, a drug used to contract the uterus, and an intravenous was attempted. She was taken to the hospital and treated for hemorrhage, hypertension and shock, and failure of her blood to coagulate. Hypertension is consistent with blood loss and it was subsequently noted in surgery that the patient had a uterine perforation. The patient was given an exploratory laparotomy and a total abdominal hysterectomy. The danger of anesthesia, infection, hemorrhage, and the loss of fertility as a result of the removal of her uterus are all negative results of the procedure. Dr. Zelnick is of the opinion that Respondent's treatment of patient 2 was below acceptable standards because the Respondent had an obligation to be certain of the age of the fetus before initiating action and did not do so. His omissions led to an unfortunate series of events which injured his patient. In fact, Dr. Zelnick goes so far as to classify Respondent's actions as gross negligence. The relative sizes of a 9 week and a 22 week fetus is so disparate that such a mistake as here is not reasonable. While a 9 week fetus is about the size of an orange, a 22 week fetus is about the size of a volley ball. While the existence of a uterine fibroid cyst can make the determination of fetal size more difficult, a doctor can make the determination. A fibroid cyst is hard and solid while a fetus is soft. In any case, if there is a question, a sonogram should be done. If the physician cannot be absolutely sure of the length of gestation by examination or history, he should take all necessary other steps to find out. If he does not, his failure constitutes negligence. Here, especially, the inconsistent BPD value, a figure with which any doctor routinely doing abortions should be familiar, should have tipped Respondent off to the need for more information. In addition, according to Dr. Zelnick, the Respondent's record keeping was poor. They do not accurately reflect or justify the procedures done on this patient. Dr. Zelnick admits that a uterine perforation is a complication which can occur without negligence on the part of the physician. Certain conditions, including an abnormality of the uterus can increase the risk, and by itself, a perforation is not necessarily bad care. If a patient has had 2 prior caesarian sections and 3 pregnancies, an attending physician could easily be slightly off in the age of the fetus. However, a doctor, as here, who does many abortions should be better at estimating the length of a pregnancy than one who does fewer. Respondent's expert, Dr. Dresden, also a Board certified obstetrician and gynecologist, who has performed over 10,000 abortions during his medical career, appeared on Respondent's behalf because, inter alia, he believes there is a grey area in the practice of medicine to which, in his opinion, the Department is not sensitive. It does not recognize differing methods of practice. He also contends that the mere fact a complication occurs which must be reported does not justify an indictment of the practitioner. Disciplinary action, in his opinion, should be reserved for cases of misconduct. As to Patient 1, Dr. Dresden feels that bi-manual examinations are quite difficult to do and are quite often inaccurate as to the length of gestation. The mistake made by Respondent here, as to the size of the fetus, is common. As to Patient 2, Dr. Dresden could see no reason for another ultrasound being taken. The government does not normally reimburse for it, and if, as here, he had found the incorrect estimate had been made and the instrument he was employing was too small, he'd go on with the procedure with a larger instrument. The is no relationship between the mis-diagnosis of size of the uterus and the risk of perforation except that there would be a greater weakness in the uterine wall in the case of a 20 week pregnancy. However, even a prudent doctor could end up perforating the wall of a uterus for a myriad of reasons. The position of the uterine cavity may be out of line, and if the instrument is not properly lined up, there is a greater risk of perforation. Also, a pregnant woman has softer uterine walls that are more easily perforated than a non- pregnant woman. Dr. Dresden could see nothing that Respondent could have done to avoid the perforations here nor does he believe Dr. Zelnick could accurately determine, from looking at the records, what instrument caused the perforation. If Patient 2 said she had had an ultrasound, he probably would have believed her. Most patients do not know enough to make up a story like that, he believes, and if he saw a record that the BPD was 5.1, he would ask a nurse or an assistant to look up the meaning of that reading and would rely on it. Here, based on what information he had about Patient 2, the 4 factors he took into consideration being better than the usual 2, he believes Respondent could have reasonably relied on the stated size of the fetus. He cannot say that Respondent used poor judgement in these cases notwithstanding his comment to the contrary in a prior letter to the Department regarding this case. By the same token, he cannot see any errors in Respondent's performance other than the mis-diagnosis of fetal size. The witness' prior professional record and his obvious antipathy toward the enforcement activities of the Department, cast some doubt on the value of his testimony, however. No evidence was presented with regard to the medical records of either patient in issue here to bear on the issue of their adequacy or inadequacy. Dr. Zelnick commented on his opinion that the records were poor, but no specific evidence of inappropriate recordation of the patients' conditions or other relevant matters was submitted to show them to be inadequate.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that Respondent's license to practice medicine in Florida be suspended for a period of six months and until such time as he has satisfactorily completed the special purpose examination of clinical skills; that upon reinstatement of his license, he be placed on probation for a period of two years under such terms and conditions as is considered appropriate by the Board of Medicine; and that he pay a fine of $1,500.00 within six months of the reinstatement of his license. DONE and ENTERED in Tallahassee, Florida this 17th day of December, 1991. ARNOLD H. POLLOCK 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 17th day of December, 1991. APPENDIX TO RECOMMENDED ORDER IN CASE NO. 91-2969 The following constituted my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all the Proposed Findings of Facts submitted by the Petitioner herein. Respondent failed to submit Proposed Findings of Fact. FOR THE PETITIONER: 1. & 2. Accepted and incorporated herein. 3. - 10. Accepted and incorporated herein. 11. & 12. Accepted. Rejected. - 27. Accepted and incorporated herein. Rejected in that the Respondent's failure to ascertain the results of the sonogram is not evidence of poor record keeping. Rejected in that Respondent's failure to ascertain the gestational age of the fetus when facing conflicting information is not evidence of poor record keeping. & 31. Accepted and incorporated herein. COPIES FURNISHED: Larry McPherson, Esquire Department of Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792 Dr. Harold J. Ticktin 2106 Drew Street, Suite 102 Clearwater, Florida 34625 Jack McRay General Counsel DPR 1940 North Monroe Street Tallahassee, Florida 32399-0792 Dorothy Faircloth Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue Whether an award authorized in Section 766.31(1)(b)1., Florida Statutes, to the parents of a child found to have sustained a birth-related neurological injury may exceed $100,000. (Stipulated Issue.)1
Findings Of Fact On March 15, 2006, Rosalin Troupe, as parent and natural guardian of Kayla Grayson, a minor, petitioned for benefits pursuant to Florida Statutes Section 766.301, et seq. The case was docketed as DOAH Case No. 06-0923N. (Stipulated Fact No. 1.) Once NICA ascertains that a claim is covered, NICA frequently offers a lump sum payment of a parental award totaling $100,000, regardless of whether there are one or two parents involved in the claim. Such offer is subject to the subsequent approval of the ALJ. (Stipulated Fact No. 2.) Pursuant to Section 766.309, Florida Statutes, the ALJ must make all NICA awards, which includes [sic] the parental award pursuant to Section 766.31(1)(b)1., Florida Statutes. An ALJ has never ordered NICA to pay a parental award in excess of $100,000, regardless of whether there was one parent or two parents involved in the claim. (Stipulated Fact No. 3.) In a typical covered claim, NICA does not customarily argue that the parental award should be less than the full $100,000 authorized. (Stipulated Fact No. 4.) Once the ALJ has ordered payment of a parental award in the amount of $100,000, unless otherwise ordered by the ALJ, NICA pays the $100,000 parental award by check made payable to the petitioning parent (if there is only one parent petitioning) or jointly to both parents (if both the parents are petitioning).5 (Stipulated Fact No. 5.) In the past, when there was a dispute between the parents with respect to the amount of the parental award to go to each parent, the ALJ has specified in the Final Order how much of the parental award would be paid to the mother and how much would be paid to the father. In those instances, the combined parental award was typically for the full $100,000. (Stipulated Fact No. 6.)6 Ms. Troupe’s March 15, 2006 Petition reflects that she was the sole petitioner in DOAH Case No. 06-0923N. (Stipulated Fact No. 7.) NICA, Ms. Troupe, and other parties participating in the proceeding [DOAH Case No. 06-0923N] eventually agreed that Ms. Troupe’s claim was compensable and executed a Stipulation, which was approved by Final Order dated September 21, 2007. (Stipulated Fact No. 8. Bracketed material provided for clarity.) NICA issued its check number 60804 in the amount of $100,000, to Kayla M. Grayson, Minor, and Rosalin Troupe as Natural Guardian, on October 9, 2007. Ms. Troupe endorsed and cashed the check, and accepted the proceeds. (Stipulated Fact No. 9.) Brian Grayson is the natural father of Kayla Grayson and her older brother, Bryan Grayson, Sr. [sic]. He was not a petitioner in DOAH Case No. 06-0923N, did not enter an appearance therein, and did not execute the Stipulation in that case. (Stipulated Fact No. 10.) The undersigned interprets this stipulation to mean that Brian Grayson, Petitioner herein, is the natural father of Kayla Grayson and Kayla’s older brother, Bryan Grayson, Jr., and that Petitioner-parent, Brian Grayson, Sr., the Petitioner herein, was not a Petitioner in DOAH Case No. 06-0923N, did not enter an appearance therein, and did not execute the Stipulation in that case. Mr. Grayson was living with Ms. Troupe at the time of Kayla’s birth, and was present when she [Kayla] was born. He and Ms. Troupe met with a NICA representative in their home while Ms. Troupe’s petition was pending. (Stipulated Fact No. Bracketed material provided for clarity.) Mr. Grayson accompanied Ms. Troupe and Kayla on medical visits, including Kayla’s initial neurological examination arranged by NICA on June 8, 2006, by Dr. Paul Carney at the Shand’s [sic] Children’s Hospital at the University of Florida in Gainesville, Florida. NICA paid for mileage, hotel and meals for this trip. Mr. Grayson also accompanied Ms. Troupe and Kayla on a visit to Orlando Regional Healthcare to obtain an EEG for Kayla. Both visits were arranged and paid for by NICA for the purpose of determining whether Kayla’s injury was compensable. (Stipulated Fact No. 12.) Mr. Grayson was aware that Ms. Troupe applied for and received NICA benefits for Kayla. (Stipulated Fact No. 13.) Ms. Troupe does not claim that NICA denied or refused to pay for any family residential or custodial care expenses before September 21, 2007. (Stipulated Fact No. 14.) Mr. Grayson, Petitioner herein, has now filed the instant case, requesting that NICA pay an additional parental award of $100,000 to him, on behalf of Kayla, but NICA has declined, based on its legal interpretation of Section 766.31(1)(b)1., Florida Statutes, which sub-section NICA contends, in this instance, limits the parental award to $100,000 for both parents, combined. Section 766.31(1), Florida Statutes, provides that upon determining a claim is compensable, the Administrative Law Judge must make an award providing compensation for a number of items, as prescribed by subparagraphs (a)-(c). Pertinent to this case, Subsection 766.31(1)(b)1., Florida Statutes, provides that such an award shall include: 1. Periodic payments of an award to the parents or legal guardians of the infant found to have sustained a birth-related neurological injury, which award shall not exceed $100,000. However, at the discretion of the administrative law judge, such award may be made in a lump sum. (Emphasis added.) Petitioner Grayson contended that Subsection 766.31(1)(b)1. entitles him to a parental award of $100,000. because he is Kayla Grayson’s natural father and because an Administrative Law Judge determined in 2007, that Kayla suffered a compensable birth-related neurological injury. He contends that the statute should be interpreted as authorizing an award of up to $100,000 for each claimant, or potential claimant, independent of the other(s); and that if the statute only authorizes an award of $100,000 for both parents in the aggregate, whether or not both parents join in the claim, it raises constitutional concerns related to due process, equal protection, and access to the courts.7 Conversely, NICA contends that Subsection 766.31(1)(b)1. is part of a cohesive statutory scheme established by Sections 766.301-766.316, Florida Statutes, designed to promote a specifically stated legislative goal, and is neither ambiguous nor subject to Petitioner’s interpretation.8 NICA interprets the subsection as authorizing an award (one award) to the parents or guardians of an eligible infant in a total amount not to exceed $100,000, regardless of whether there are one or two parents filing the claim. Thus, NICA argues that if there are two parents involved in the NICA claim, or even if they file sequentially, then a maximum award of $100,000, is authorized to be awarded to both parents, combined. However, both parties concede that the Administrative Law Judge is without authority to address the constitutionality of Subsection 766.31(1)(b)1., Florida Statutes. The statutory provision at issue was first enacted during a special session in 1988, as part of Chapter 88-1, Laws of Florida. At that time, Section 766.31(1)(b), Florida Statutes (1988 Supp.), provided: Periodic payments of an award to the parent or legal guardian of the infant found to have sustained a birth-related neurological injury, which award shall not exceed $100,000. However, at the discretion of the deputy commissioner, such award may be made in a lump sum. During the 1989 regular session, Section 766.31(1)(b), Florida Statutes,9 was amended, as follows: Periodic payments of an award to the parents parent or legal guardians guardian of the infant found to have sustained a birth-related neurological injury, which award shall not exceed $100,000. However, at the discretion of the deputy commissioner,[10] such award may be made in a lump sum. Ch. 89-186, § 5, at 768, Laws of Fla. The stated reason for the amendment was "to clarify the fact that the maximum award of $100,000 is for both parents or legal guardians and is not intended to award up to $100,000 for each parent or legal guardian." Florida House of Representatives, Insurance Committee, Final Staff Analysis & Economic Impact Statement (June 30, 1989), Section 5, page 3. (NICA Exhibit 4.)
The Issue This is a license discipline case in which a medical doctor is charged by administrative complaint with five counts of violations of paragraphs (h), (k), (m), and (t) of Section 458.331(1), Florida Statutes (1988 Supp.).
Findings Of Fact Findings based on parties' stipulations The Respondent, Vladimir Rosenthal, M.D., (hereinafter "Respondent" or "Dr. Rosenthal") is, and at all material times was, a medical doctor, license number ME 0045574, who practiced at 1320 South Dixie Highway, Coral Gables, Florida. Dr. Rosenthal at all material times owned the business operating as Today's Women Medical Center located at 1320 South Dixie Highway, Suite 1070, Coral Gables, Florida. On or about November 3, 1988, Dr. Rosenthal performed an elective abortion on patient B.F. under general anesthesia. On or about November 3, 1988, Dr. Rosenthal ordered a pathology report of the products of the procedure performed on patient B.F. The pathology report regarding patient B.F. bears the date November 8, 1988. The pathology report revealed no chorionic villi and recommended a "close follow-up" of the patient. Missed abortion and continued pregnancy is a recognized risk of early (first trimester) abortions. Patient B.F. suffered no harm as a result of the November 3, 1988, procedure. On or about December 7, 1988, patient B.F. presented to Dr. Rosenthal. On or about December 7, 1988, patient B.F.'s uterus was examined and found to be enlarged. Subsequently, a repeat pregnancy test was performed on patient B.F., which revealed she was still pregnant. On or about December 10, 1988, Dr. Rosenthal performed a second abortion on patient B.F. with positive results. Patient B.F. suffered no harm as a result of the December 10, 1988, procedure. Findings based on evidence at hearing The Respondent specializes in the area of gynecology, but does not practice obstetrics. In the course of his medical practice he regularly performs first trimester abortions. The Respondent is very experienced in the performance of first trimester abortions. In recent years he has averaged five thousand (5,000) such procedures per year. Patient B.F. normally goes to Dr. Nahid Mansoori for routine treatment of gynecological matters. Patient B.F. was seen by Dr. Mansoori on October 28, 1988, with a history of a missed menstrual period. Dr. Mansoori examined the patient and observed that the patient had an enlarged uterus and appeared to be 5 or 6 weeks pregnant. The patient expressed an interest in having an abortion. Because Dr. Mansoori does not perform abortions, she referred patient B.F. to the Respondent. Dr. Mansoori also referred patient B.F. to Dr. Martin S. Goldstein for an ultrasound examination. Dr. Mansoori referred patients to the Respondent on a regular basis. She did so for several reasons, including the facts that (a) patients she referred to the Respondent uniformly reported back to her that they were pleased or satisfied with the services they received from the Respondent, (b) none of her patients had complained about their treatment by the Respondent, and (c) none of the patients she had referred to the Respondent had experienced any infection or problems. On October 31, 1988, Dr. Martin S. Goldstein performed an ultrasound examination of patient B.F. On the basis of that ultrasound examination, Dr. Goldstein concluded and reported that the "gestational age" of patient B.F.'s pregnancy was 6 weeks, 0 days. Dr. Goldstein also concluded and reported that patient B.F. had an intrauterine pregnancy, thus ruling out an ectopic pregnancy. On November 3, 1988, patient B.F. went to the Respondent's clinic at 1320 South Dixie Highway for the purpose of having an abortion. The Respondent remembers this particular patient because she was a medical professional and her husband was an attorney. Because of their respective professions, the Respondent was extra careful to explain everything involved in the process to both B.F. and her husband. He especially explained to both of them the importance of a post-abortion follow up examination at either the Respondent's clinic or at the office of the patient's regular gynecologist. Patient B.F. said that she would return to Dr. Mansoori, her regular gynecologist, for the follow up examination. When patient B.F. went to the Respondent's clinic on November 3, 1988, she told the Respondent that she had had an ultrasound examination. The Respondent called Dr. Mansoori and Dr. Mansoori told him that the results of the ultrasound examination indicated a "gestational age" 1/ of six weeks and that the ultrasound examination confirmed an intrauterine pregnancy. Dr. Mansoori also mentioned that her clinical examination of patient B.F. indicated a "gestational age" of five or six weeks. Upon manual examination of the patient, the Respondent concluded, and noted in the patient's medical record, that patient B.F.'s uterus was enlarged to a size consistent with a "gestational age" of five weeks. Later that same day, the Respondent performed an abortion procedure on patient B.F. Following the abortion procedure, patient B.F. took antibiotic medication for several days, which medication had been prescribed and/or dispensed by the Respondent. The Respondent ordered a pathology report of the products of the abortion procedure performed on patient B.F. on November 3, 1988. The Respondent does not order pathology reports on all of his patients, but he did so in this case because it was an early pregnancy, and also because he wanted to take extra care in view of the professions of B.F. and her husband. The pathology laboratory is supposed to call Dr. Rosenthal on all "abnormal" reports. Sometimes the laboratory fails to call and sometimes the laboratory fails to send a written report. The Respondent has established office procedures for handling laboratory reports to try to prevent any reports from going astray and to identify those that do go astray so that follow up activity may be taken. Pursuant to the Respondent's established office procedures, all laboratory reports received at the clinic must be seen and signed by the Respondent before being placed in a patient chart. When a patient returns for her follow up visit, the laboratory report is reviewed during the course of that visit. If a laboratory examination has been ordered, but there is no laboratory report in the chart at the time of the follow up visit, the laboratory is called by telephone. The Respondent usually makes these calls himself. Pursuant to the Respondent's established office procedures, missing laboratory reports for patients who do not return for follow up visits or who return to their regular physicians for follow up visits are picked up when monthly reports to the Department of Health and Rehabilitative Services are compiled and submitted. In order to complete these monthly reports, a log is kept of every patient who has an abortion procedure performed at the Respondent's clinic. The information kept in the log and reported to DHRS includes: the date of surgery, the estimated "gestational age" of the patient, whether a pathology report was ordered, the results of the pathology report, and the date the pathology report was received by the clinic. Such forms were in use at the time B.F. was a patient at the Respondent's clinic. If any pathology reports "fell through the cracks," they were picked up each month when the reports were prepared. The reports are usually prepared on the ninth or tenth of each month. The implementation of these office procedures for the purpose of following up on laboratory reports is sufficient to comply with applicable standards of medical care. The pathology laboratory prepared a report regarding the material removed from patient B.F. during the November 3, 1988, abortion procedure. The written laboratory report was dated November 8, 1988. The most significant finding noted on the laboratory report was "no chorionic villi." Because of this finding, the laboratory report also stated: "close follow up of patient is recommended." The significance of the notation of "no chorionic villi" is that it indicates that the pathology laboratory examination did not reveal evidence of any fetal tissue or other "products of conception." The need for close follow up in this instance is because the absence of chorionic villi can be due to a number of different things. 2/ On November 18, 1988, patient B.F. went to Dr. Mansoori's office for a post-abortion follow up visit. At that time the patient was complaining of a vaginal "yeast" infection, a not uncommon occurrence following a course of antibiotic medication. Dr. Mansoori treated the patient's "yeast" infection with a prescription for Monistat Vaginal Cream. Dr. Mansoori's medical records for that day also include the following notations regarding the patient B.F.: "Had abortion by Today's Woman. Post AB check up O.K." 3/ Dr. Mansoori told patient B.F. to get back in touch with her if the patient missed her next menstrual period. On December 6, 1988, patient B.F. called Dr. Mansoori to report that she had missed her menstrual period. Dr. Mansoori advised her to return to the Respondent and patient B.F. agreed to do so. Dr. Mansoori called the Respondent to advise him that patient B.F. would be returning because she had missed her menstrual period. Dr. Mansoori also arranged for another ultrasound examination to be performed on patient B.F. by Dr. Goldstein. On December 7, 1988, patient B.F. returned to the Respondent's clinic where she was seen and examined by the Respondent. Examination revealed that the patient's uterus was mildly enlarged. A pregnancy test administered that day indicated that the patient was still pregnant. On December 7, 1988, the Respondent realized that he did not have a report from the pathology laboratory, so he called the laboratory and was advised that the most significant finding of the pathology report was "no chorionic villi." The substance of the telephone conversation with the pathology laboratory was noted in the patient's medical record. When he made the telephone call to the pathology laboratory on December 7, 1988, the Respondent had not received the laboratory's written report dated November 8, 1988, 4/ nor had he been otherwise advised of the results of the pathology study of the materials removed during the November 3, 1988, abortion procedure. On December 8, 1988, Dr. Martin S. Goldstein performed a second ultrasound examination of patient B.F. On the basis of the second ultrasound examination, Dr. Goldstein concluded and reported that the "gestational age" of patient B.F.'s pregnancy was 11 weeks, 6 days. This second gestational age was three days older than one would have predicted based on the October 31, 1988, ultrasound examination. In both of the ultrasound examinations of patient B.F., Dr. Goldstein relied upon the "crown rump" measurement as the basis for his estimate of "gestational age." On December 10, 1988, when patient B.F. returned to the Respondent's office for the second abortion procedure, the Respondent conducted a clinical examination of the patient before commencing the procedure. On the basis of his own clinical examination of the patient, the Respondent was of the opinion that patient B.F.'s "gestational age" was 8 or 9 weeks. He reported this on the "Physical Exam" portion of the patient's chart by writing "8-9" beside the entry for uterus. After the patient was anesthetized and the Respondent could examine her while she was more relaxed, the Respondent further examined the patient's uterus and was of the opinion that its size corresponded to a "gestational age" of 8 weeks. He noted this opinion in the "Operative Notes" portion of the patient's chart. It was, and continues to be, the Respondent's opinion that his December 10, 1988, estimates of the patient's "gestational age" were correct. Although he was aware of Dr. Goldstein's ultrasound examination which reported a somewhat older "gestational age," the Respondent had confidence in his own clinical findings and relied on his own clinical findings, which he duly recorded in the patient's medical chart. Relying on his own estimate of "gestational age," the Respondent performed the abortion procedure on December 10, 1988, on patient B.F. with a number eight suction tip. The abortion procedure was accomplished successfully and without any difficulty or complication. A report from a pathology laboratory confirmed that the December 10, 1988, abortion procedure was successful. 5/ The prevailing standards of acceptable care do not require a physician to order a pathology examination of the material removed during the course of a routine first trimester abortion procedure. In an abortion procedure involving a very early pregnancy, a physician may wish to order such a pathology examination in order to be more certain as to the results of the procedure, but it is a matter of physician preference, rather than a requirement. A physician who orders a pathology examination of the material removed during a first trimester abortion procedure has an affirmative duty to follow up on the examination and find out the results of the examination within a reasonable period of time. 6/ The Respondent's follow up on December 7, 1988, on the results of the pathology examination of the material removed from patient B.F. during the November 3, 1988, procedure was reasonable under the circumstances. 7/ The Respondent's delay until December 7, 1988, before following up on that pathology examination was not a departure from applicable standards of medical care. 8/ The Respondent's medical records for patient B.F. justify the course of treatment of the patient. The use of ultrasound examination as a method of estimating "gestational age" is not an exact science and cannot be relied upon to determine an exact "gestational age." As a general rule, "gestational age" estimates derived by means of ultrasound examination are accurate within a margin of error of plus or minus two weeks. 9/ Clinical or manual examination of a patient as a method of estimating "gestational age" is also not an exact science and cannot be relied upon to determine an exact "gestational age." As a general rule, "gestational age" estimates derived by means of clinical or manual examination of a patient are accurate within a margin of error of plus or minus two weeks, if done by an experienced physician. It is not a departure from applicable standards of medical care for an estimate of "gestational age" to vary from the actual "gestational age" by as much as plus or minus two weeks when the estimate is based on the physician's clinical or manual examination of the patient. A reasonably prudent physician who is experienced in clinical or manual examination of patients for the purpose of estimating "gestational age" should rely on his own findings, even if those findings appear to conflict with findings based on ultrasound examination. Such a physician should also note his own findings on the patient's medical records, regardless of what is reported by the ultrasound. There is no great discrepancy between the estimate of "gestational age" reported in Dr. Goldstein's ultrasound report of December 8, 1988, and the Respondent's estimate of "gestational age" on December 10, 1988. The Respondent's notations in patient B.F.'s medical records on December 10, 1988, to the effect that her pregnancy was of a "gestational age" of eight weeks was an honest notation of the Respondent's clinical judgment and was not a statement the Respondent knew to be false. 10/ Similarly, those notations were not deceptive, untrue, or fraudulent representations. On or about August 3, 1989, the Respondent's clinic, known as Today's Woman Medical Center, located at Suite 1070, 1320 South Dixie Highway, Coral Gables, Florida, was inspected by an employee of the Office of Licensure and Certification of the Department of Health and Rehabilitative Services. 11/ At the time of that inspection the Respondent was not present at the clinic, there were no procedures being performed at the clinic, and there were no patients at the clinic.
Recommendation On the basis of all of the foregoing, it is RECOMMENDED that a Final Order be entered in this case DISMISSING all charges against the Respondent, Vladimir Rosenthal, M.D. DONE AND ENTERED this 2nd day of October, 1992, at Tallahassee, Leon County, Florida. MICHAEL M. PARRISH, 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 2nd day of October, 1992.
The Issue The issues in these cases are whether Respondent violated Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes (2002), in DOAH Case No. 09-4678PL; Subsections 456.072(1)(l), 458.331(1)(m), and 458.331(1)(t), Florida Statutes (2003), in DOAH Case No. 09-4679PL; and Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes (2005), in DOAH Case No. 09-4680PL, and, if so, what discipline should be imposed.
Findings Of Fact At all times relating to the three Administrative Complaints at issue, Dr. Kachinas was a licensed medical doctor within the State of Florida, having been issued license number ME 65595. He is board-certified by the American Board of Obstetrics and Gynecology. DOAH CASE NO. 09-4678PL In 2002, Dr. Kachinas was working at several clinics that were owned by the same individual. He received payment from Sarasota Women’s Health Center and Tampa Women’s Health Center. His primary office was located in Sarasota, but he rotated through the offices located in Clearwater and Tampa. He was advised that he would be attending a patient in the Tampa office. One of the medications that he used in his method of sedating patients, Propofol, was not available in the Tampa office. He took a vial of the Propofol and took it to the Tampa office, holding the vial in his hand. While at the Tampa office, Dr. Kachinas drew the Propofol into a syringe. He did not have to use the Propofol for the patient. He placed the syringe filled with Propofol inside the sock that he was wearing. Dr. Kachinas transported the syringe back to the Tampa office. He used this method of transport so that the office manager in the Tampa office would not know that he was transporting the drug. When he got back to the Tampa office, he placed the filled syringe in a secure place. Propofol must be used within 24 hours after being drawn into a syringe. The next day it was decided that the drug would not be used on another patient, and Dr. Kachinas wasted the syringe filled with Propofol. At the clinics where Dr. Kachinas worked, there were no logs to keep track of the drugs, except for the drug Fentanyl. Dr. Kachinas acknowledged in a letter dated January 30, 2007, to the Department of Health that his method of transporting Propofol was “unorthodox.” In the same letter, Dr. Kachinas acknowledged that “a reasonable and prudent doctor would not generally transport medication in that manner, but foolishness seemed reasonable in that aberrant environment.” DOAH CASE NO. 09-4679PL On March 26, 2004, B.S. presented to Premier Institute for Women’s Health (Premier) for an elective termination of pregnancy. Dr. Kachinas was the physician who handled the procedure. Dr. Kachinas maintained records relating to B.S. at Premier. In 2004, Petitioner subpoenaed B.S.’s records from Dr. Kachinas’ office. Petitioner received a packet of documents, which purported to be B.S.’s medical records. In July 2006, Lori Jacobs, an employee of Premier, sent Petitioner another copy of the documents sent in 2004. Neither the records provided in 2004 nor the records provided in 2006 contain progress notes for B.S.’s treatment on March 26, 2004, and March 27, 2004. For the first time on November 5, 2009, Dr. Kachinas produced a three-page document, which he claimed was part of B.S.’s medical records that had been misplaced in B.S.’s insurance file. Two of the pages purported to be progress notes for March 26 and 27, 2004. The third page, which is also labeled as a progress note, is dated June 29, 2004, and appears to relate to insurance claims. The two pages relating to March 26 and 27 are on paper which is a different color from the progress note relating to insurance claims and the progress notes which were previously furnished in 2004 and 2006.1 Additionally, the progress notes for March 26 and 27, 2004, contain a break in each of the ruled lines on the sheets on both the right and left sides of the sheets. The insurance progress note and the progress notes furnished in 2004 and 2006 do not have such breaks in the ruled lines. Dr. Kachinas completed a Laminaria Insertion report documenting procedures done on March 26, 2004, and March 27, 2004. The March 26, 2004, report documents the insertion of Laminaria and administration of medications. The comment section of the report documents the removal of the Laminaria and administration of medications on March 27, 2004. The comment section continues to document the administration of medications and the taking of vital signs after the removal of the Laminaria and also the transfer of the patient to Doctors Hospital. The detail on the comment sections suggests that Dr. Kachinas was making his progress notes in the Laminaria Insertion report. The failure to produce the purported progress notes for March 26 and 27, 2004, until November 5, 2009; the difference in the color of the paper of the March 26 and 27, 2004, purported progress notes and the other progress notes in Dr. Kachinas’ records; the presence of breaks in the ruled lines on the March 26 and 27, 2004, purported progress reports, which do not appear on the other progress notes; and the detail of the comments on the Laminaria Insertion report support the conclusion that the progress notes submitted as Respondent’s Exhibit 1 were not done contemporaneously with the treatment given to B.S. on March 26 and 27, 2004, but were prepared for this proceeding. Thus, the progress notes for March 26 and 27, 2004, are not credited. Dr. Kachinas determined B.S.’s pregnancy to be at approximately 23½-to-24 weeks’ gestation, the last week of the second trimester. He confirmed by sonogram that the gestation period was 24 weeks. On March 26, 2004, Dr. Kachinas began the induction of labor ordering the insertion of ten Laminaria, which are osomotic cervical dilators which cause the cervix to open and allow easier emptying of the uterus. Dr. Kachinas’ records do not show that B.S.’s medical history was taken prior to the insertion of the Laminaria. However, Dr. Kachinas did take a medical history of B.S. at the time of her admission to Doctors Hospital, and the history is recorded in the medical records. Prior to the insertion of the Laminaria, Dr. Kachinas’ records do show that a limited physical examination of B.S. was done. The Laminaria Insertion report shows that B.S.’s baseline blood pressure, temperature, and pulse were taken and recorded. There was no expert testimony of what other physical examination should have been done. Dr. Kachinas injected the fetus with Digoxin, which is injected directly into the fetus to stop the fetal heartbeat, causing an Intrauterine Fetal Demise (IUFD). The injection of the Digoxin was not documented in B.S.’s medical records. B.S. was then released from Premier. On March 27, 2004, B.S. returned to Premier. Prior to removing the Laminaria, Dr. Kachinas did an ultrasound and determined that there was still fetal heart activity and fetal movements. Dr. Kachinas continued the labor induction procedure by removing the Laminaria and administering Cytotec and high dosages of Pitocin. When the Laminaria were removed, there was a rupture of membranes with a loss of essentially all the amniotic fluid. Sometime during the afternoon of March 27, 2004, Dr. Kachinas did another ultrasound and determined that there was no fetal heart activity. Based on the length of time from the Digoxin injection to the ultrasound showing no fetal heart activity, the loss of amniotic fluid, and the administering of medication to cause contractions, Dr. Kachinas determined that the Digoxin injection was not the cause of death. On March 27, 2004, at approximately 6:30 p.m., Dr. Kachinas transferred B.S. to Doctors Hospital and had her admitted to the hospital for failure to progress with the induction of labor procedure. While at the hospital, B.S. continued to experience pain. On March 28, 2004, Dr. Kachinas performed the following procedures on B.S.: mini-laparotomy, hysterotomy, removal of products of conception, and a modified Pomeroy bilateral tubal ligation. In his description of the procedures, he stated that the fetal demise was at least of 48 hours duration. However, Dr. Kachinas’ records do not reflect the time of the fetal demise. Jorge Gomez, M.D., Petitioner’s expert witness, credibly testified that a physician is required to document the time of the fetal demise. In the hospital records following B.S.’s surgery, Dr. Kachinas listed the post-operative diagnosis as a failure to induce labor, an intrauterine fetal demise, a thin umbilical cord, and asymmetric intrauterine growth retardation, a condition in which the fetus is smaller than expected for the number of weeks of pregnancy. An autopsy was performed on the fetus. A surgical pathology report was also issued. The pathology report showed mild infarcts on the maternal side. On the fetal death certificate, Dr. Kachinas listed the immediate causes for the IUFD as a possible cord incident and multiple placental infarctions. Dr. Kachinas did not document the elective termination or the Digoxin injection on the fetal death certificate. Dr. Gomez disagrees with the reasons for IUFD given on the death certificate. His credible reading of the pathology report does not indicate that the infarcts were severe enough to have contributed to the fetal demise. His credible reading of the pathology report does not indicate that there was any evidence of a cord incident. Dr. Gomez is of the opinion that the cause of death should have been listed as elective termination. Dr. Gomez’ opinion is credited. However, Dr. Gomez did not give an opinion on whether the fetal demise was caused by the injection of Digoxin. DOAH CASE NO. 09-4680PL On December 13, 2005, K.M. was seen by Walter J. Morales, M.D., at Florida Perinatal Associates, which specializes in internal fetal medicine. Dr. Morales performed an ultrasound on K.M., who was pregnant with twins as a result of in vitro fertilization. The ultrasound revealed that the twins were fraternal, meaning that each twin had a separate placenta and a separate sac. One of the twins, Twin A, had an anomaly called a cystic hygroma, which results from an obstruction, causing the lymphatic fluid, which normally drains into the juglar vein, to accumulate in the neck area. Approximately 50 percent of the fetuses which have this anomaly in the first trimester also have a chromosomal anomaly, such as Down syndrome. The decision was made to have K.M. return to Florida Perinatal Associates in three weeks for further evaluation. On January 3, 2006, Edgard Ramos-Santos, M.D., a partner of Dr. Morales, performed another ultrasound on K.M. Dr. Ramos-Santos found that Twin A, a male, had a cystic hydroma, a thickening of the nuchal fold2, and shortened femur and humerus. These findings are soft markers for abnormal chromosomes. The ultrasound also revealed a possible heart defect. At the time of the ultrasound, Twin A was cephalic bottom, meaning that Twin A was positioned lowest in the uterus. Dr. Ramos-Santos also performed an amniocentesis on Twin A on the same date as the ultrasound. The amniocentesis showed that Twin A had an abnormal chromosome pattern compatible with trisomy 21 or Down syndrome. Both ultrasounds showed that Twin B, a female, appeared to be normal. At the request of K.M., no amniocentesis was performed on Twin B on January 3, 2006. At the time of the ultrasound performed on January 3, 2006, the presentation of Twin B was cephalic right. The findings of the January 3, 2006, ultrasound were discussed with K.M. and her husband. On January 9, 2006, Dr. Ramos-Santos discussed the results of the amniocentesis with K.M.’s husband. It was decided that a selective feticide would be performed on Twin A. Selective feticide is a procedure in which a solution of potassium hydroxide is injected into the fetus’ heart to make the heart stop beating. K.M. was referred to Dr. Kachinas at Premier for the selective feticide. On January 10, 2006, Roberta Bruce, a nurse at Florida Perinatal Associates, sent to Premier by facsimile transmission the January 3, 2006, ultrasound report for K.M. and K.M.’s insurance information. The cover page for the facsimile transmission included a note from Ms. Bruce, which stated: “* FYI Fetus have different gender. The male is the affected one.” The standard of care as specified in Section 766.102, Florida Statutes (2005), requires a physician performing a selective feticide to correctly identify the affected fetus. Dr. Kachinas did not correctly identify Twin A prior to performing the selective feticide and performed the procedure on Twin B, the normal fetus. Dr. Kachinas performed an ultrasound on K.M., but failed to identify the correct position of Twin A in relation to K.M. The ultrasound done on January 3, 2006, by Dr. Ramos-Santos showed that Twin A was located at the bottom and Twin B was located to the right of K.M. In his progress notes, Dr. Kachinas placed Twin A on the right and Twin B on the left. Although it is possible for twins to shift positions, it is not probable that the twins shifted from left to right. Dr. Kachinas performed an ultrasound, but failed to identify that Twin A was the fetus with multiple anomalies. Although the standard of care required Dr. Kachinas to do a Level 2 ultrasound evaluation, a Level 1 ultrasound evaluation would have identified the cystic hygroma, the shortened long bones, and the sex of Twin A. Dr. Kachinas failed to perform an adequate ultrasound evaluation by failing to identify the anomalies and the gender of Twin A. Dr. Kachinas’ notes do not show whether Twin A or Twin B had anomalies. His notes did not identify the sex of each of the twins. His notes did not document the attempts that Dr. Kachinas made to identify the anomalies such as a recording of the length of the long bones or any examination made to identify the sex of each of the twins. On January 24, 2006, K.M. returned to Florida Perinatal Associates for another consultation. Dr. Morales performed another ultrasound, which revealed that Twin A, who had the anomalies, was still viable. The ultrasound revealed the continued presence of a cystic hygroma, the thickening of the nuchal fold, shortened extremities, and a congenital heart defect. The ultrasound also showed that the viable twin was male. The presentation of Twin A was shown by the ultrasound as cephalic bottom.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED as to DOAH Case No. 09-4678PL that a final order be entered finding that Dr. Kachinas violated Subsection 458.331(1)(t), Florida Statutes (2002), by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent physician as being acceptable under similar conditions and circumstances; finding that Dr. Kachinas did not violate Subsection 458.331(1)(m), Florida Statutes (2002); imposing an administrative fine of $2,500; and placing Dr. Kachinas on probation for one year. Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED as to DOAH Case No. 09-4679PL that a final order be entered finding that Dr. Kachinas did not violate Subsections 456.072(1)(l) and 458.331(1)(t), Florida Statutes (2003); finding that Dr. Kachinas violated Subsection 458.331(1)(m), Florida Statutes (2003); imposing an administrative fine of $1,000; and placing Dr. Kachinas on probation for one year. Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED as to DOAH Case No. 09-4680PL that a final order be entered finding that Dr. Kachinas violated Subsection 458.331(1)(t), Florida Statutes (2005), by committing gross medical malpractice; finding that Dr. Kachinas violated Subsection 458.331(1)(m), Florida Statutes (2005); imposing an administrative fine of $2,000 and placing him on probation for one year for the violation of Subsection 458.331(1)(m), Florida Statutes (2005); and revoking his license for the violation of Subsection 458.331(1)(t), Florida Statutes (2005). DONE AND ENTERED this 26th day of January, 2010, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 26th day of January, 2010.
The Issue The issue presented is whether Respondent is guilty of the allegations contained in the Administrative Complaint filed against him, and, if so, what disciplinary action should be taken against him, if any.
Findings Of Fact At all times material hereto, Respondent has been licensed as a physician in the State of Florida, having been issued license number ME 0017602. He graduated from St. Louis University School of Medicine in 1966. He taught obstetrics and gynecology at the Portsmouth Naval Hospital in 1970-1972. He was board-certified in obstetrics and gynecology in 1972 and retired from the active practice of medicine in 1996. Licensed in Missouri, Virginia, and Florida, Respondent has never been disciplined by Petitioner or any other licensing authority. During his active practice of obstetrics and gynecology, Respondent specialized in high-risk obstetrics, i.e., the treatment of patients whose lives and pregnancies are at risk during the course of their pregnancy. He treated patients with diabetes, with heart disease, with blood disease, and with abnormal pregnancies such as ectopic pregnancies. He is well respected in the medical community, including by others who practice high-risk obstetrics. He enjoys a reputation for being a caring, concerned, intelligent, and capable physician. On November 30, 1993, R. C. was a 35-year-old patient who had been seen previously by Respondent's associate but not by Respondent. She had a long history of infertility and had been treated with fertility drugs. She had had one ruptured ectopic pregnancy that resulted in the removal of her right ovary. She had three failed attempts at in vitro fertilization. She reported to Respondent that she felt pregnant. She had taken three home pregnancy tests, which were positive. Her HMO primary care physician, following laboratory confirmation of her pregnancy, had referred her to Respondent. She advised Respondent that her last menstrual period was October 16, 1993. Respondent conducted a physical examination and agreed that she was pregnant. Her breasts were tender, and her uterus may have been a little soft but it was not enlarged. The presence of a normal-sized uterus at six weeks gestation, while not unusual, is one possible indication that a woman might have an abnormal pregnancy or be in the process of having a miscarriage. It raised the suspicion that the nature of her pregnancy, intra-uterine versus abnormal, must be considered by Respondent. However, enlargement of the uterus during pregnancy is different for each patient. Significantly, R. C. did not have any bleeding. She had no abdominal pain, and no adnexal masses were palpated. Essentially, she was asymptomatic for an abnormal pregnancy. Because of her history, Respondent considered R. C. to be at a higher risk for an abnormal or ectopic pregnancy than that expected for a normal female from the general population. It is generally understood that the risk of a repeat ectopic pregnancy is between 10 and 15 percent. Respondent was aware that even with an ectopic pregnancy, the uterus undergoes many of the changes associated with an early normal intra-uterine pregnancy, including an increase in uterine size and softening of the cervix. These changes occur as a result of the hormones circulating through the body during the early stages of pregnancy. Concerned since R. C. was at risk although asymptomatic, Respondent decided that the prudent course would be to evaluate R. C.'s pregnancy to rule out an ectopic or other abnormal pregnancy. Consequently, he took steps different from those that would be taken during a normal routine pregnancy. Respondent obtained an immediate quantitative human chorionic gonadotropin (hCG) value that day. The quantitative hCG is a diagnostic test available to physicians to evaluate the progress of a pregnancy when there is concern as to its nature. It is not a test that is ordered when there is no concern as to the nature of the pregnancy. The test measures the secretions of the placenta. It confirmed R. C.'s pregnant state and was an indicator of the presence of a placenta somewhere in her body. The hCG value was reported as 7,371. By itself, the hCG value told Respondent little about R. C.'s pregnancy. It did, however, provide some comfort that R. C. might have an intra-uterine pregnancy, particularly given her lack of symptoms for an ectopic pregnancy. It is generally understood that less than 25 percent of ectopic pregnancies have hCG values greater than 6,000. With an hCG value greater than 7,000, R. C. was in the group more likely to have an intra-uterine pregnancy. Her lack of symptoms also indicated that she had an intra-uterine pregnancy. It is generally understood that bleeding is present in over 85 percent of cases where there is an ectopic pregnancy. Pain is present in over 90 percent of the cases where there is an ectopic pregnancy, and over half of such women have palpable adnexal masses or lumps. R. C. was not experiencing any of what are known as the classic triad of symptoms for an ectopic pregnancy. Respondent obtained the hCG to be used as a baseline. The quantitative hCG is best used serially, and a single value has no real meaning in evaluating the nature of a pregnancy. By repeating the test at certain intervals, a physician can observe where the pregnancy might be going from a hormonal point of view. The initial value is a starting point from which other tests can be used to determine if the pregnancy is likely normal or abnormal. In an early normal intra-uterine pregnancy, the hCG values generally double approximately every 48 hours. Then, the rise begins to plateau, and the doubling time lengthens. To determine the course of a pregnancy, repeat tests of the hCG at set intervals can be an aid in the diagnosis of ectopic pregnancies. The possibility of an ectopic or other pathologic pregnancy exists when the hCG value fails to rise in accordance with the expectations of a normal intra-uterine pregnancy or does not rise at all. Although R. C. was asymptomatic, given her history, Respondent determined that he should obtain a repeat hCG and an ultrasound examination to confirm the presence of an intra- uterine pregnancy. He scheduled the repeat hCG and the ultrasound to be performed 7 to 10 days from that visit, or December 9, 1993. Respondent's plan of treatment was reasonable under the circumstances. If R. C. had had any of the classic symptoms consistent with an ectopic pregnancy, the standard of care would have required an immediate ultrasound. However, R. C. did not have any symptoms. It is a matter of physician judgment as to when an ultrasound examination and repeat hCG should be obtained for an asymptomatic patient. When there is no urgent need for the tests, the standard of care does not define the time frame in which the tests should be performed. Respondent wanted to wait another 7 to 10 days to allow for better visualization of the fetus on the ultrasound and to avoid a misinterpretation of the result of the repeat hCG test. By waiting, Respondent would likely obtain more useful information from the ultrasound than if the ultrasound were performed that day or during the next few days. He wanted to combine the findings of the ultrasound with the results of the repeat hCG test. Reasonably-prudent, similarly-trained physicians support Respondent's conclusions. The possibility of a misinterpretation of the hCG results is lessened by the passage of a reasonable period of time between tests. Before she left the office on November 30, 1993, R. C. was asked to contact Respondent in two days to obtain the results of her initial hCG test and to follow-up on her condition. On December 2, 1993, R. C. contacted Respondent. During their telephone conversation, R. C. expressed concern that her pregnancy might be in the fallopian tube rather than the uterus. Respondent wanted to calm her fears. He inquired as to how she was doing, and she reported that she was doing fine, no bleeding or pain. Generally, an ultrasound is not performed until at least the fifteenth or sixteenth week. After speaking with R. C. on December 2, 1993, Respondent continued with his plan to obtain an ultrasound evaluation of R. C. in her 7th or 8th week of gestation. Her history indicated that Respondent should confirm the nature of her pregnancy, and Respondent took those steps necessary to monitor and confirm R. C.'s condition. At approximately 6:00 p.m. on December 6, 1993, R. C. contacted Respondent's office and spoke with his midwife. R. C. complained that she was having some cramping that began after she had eaten a very heavy meal. This is not an unusual complaint during a pregnancy. R. C. reported that the cramping was resolving, but she just wanted to touch base with someone. The midwife advised her to go to the emergency room if the cramping worsened during that evening or if she was concerned. The midwife also advised R. C. that if she felt better by morning but not completely better, she should come in to the office. If she felt fine, she should keep her scheduled appointment for the ultrasound. The advice given to R. C. by the midwife was appropriate and consistent with the standard of care. R. C. began to experience severe lower abdominal pain on the morning of December 7, 1993, and was taken to the emergency room of Bethesda Memorial Hospital. She did not have any vaginal bleeding. Respondent was present in the hospital when R. C. arrived at the emergency room, and he came immediately upon being called. An ultrasound was performed and confirmed that the uterus was empty except for a pseudo-gestational sac. A viable ectopic pregnancy was seen in the left adnexal area with an estimated gestational age of 6 weeks. Respondent assessed R. C. as having a leaking tubal pregnancy, and he had her taken to surgery immediately following the ultrasound. Respondent removed her left tube and ovary and provided blood transfusions due to free blood found in the abdomen. R. C. experienced a fever following the surgery, but she recovered and was discharged from the hospital. Respondent's plan and action in evaluating R. C. on her November 30, 1993, visit to his office were in accordance with the standard of care, and were reasonable and appropriate. The patient's telephone report of doing well on December 2, 1993, strengthened Respondent's judgment that there was no immediate need to obtain an ultrasound and repeat hCG and that he could wait until those tests were likely to be reliable.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding Respondent not guilty and dismissing the Administrative Complaint filed against him in this cause. DONE AND ENTERED this 23rd day of February, 2000, in Tallahassee, Leon County, Florida. LINDA M. RIGOT 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 23rd day of February, 2000. COPIES FURNISHED: Tanya Williams, Executive Director Board of Medicine Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0750 Angela T. Hall, Agency Clerk Department of Health 2020 Capital Circle, Southeast Bin A02 Tallahassee, Florida 32399-1703 Britt Thomas, Esquire M. Rosena Hitson, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Grover C. Freeman, Esquire Jon M. Pellett, Esquire Freeman, Hunter & Malloy 201 East Kennedy Boulevard, Suite 1950 Tampa, Florida 33602
The Issue The issue in this case is whether the license of Allen B. Erde, M.D., should be disciplined by the Florida Board of Medicine based upon actions he is alleged to have taken, or failed to have taken, between August and November, 1986, in the care and treatment of his patient, C.W.
Findings Of Fact At all times material hereto, Respondent has been licensed as a physician in the State Of Florida, having been issued license number ME-0008625. Respondent was C.W.'s obstetrician during her pregnancy in 1986, and initially examined her on August 26, 1986, when she was six weeks pregnant. During this initial visit, C.W. was informed by Respondent that her pregnancy was progressing normally. At her second visit, on September 23, 1986, Respondent detected no fetal heartbeat. However, he informed C.W. that this was not a problem. He requested that she bring her husband with her for her third visit so that they both could hear the heartbeat. Prior to her third visit, C.W. saw Respondent in his office on October 6, 1986, complaining of urinary problems, and a stiff neck and back. Respondent treated her for a urinary tract infection. Later that same day she began to bleed vaginally, passed clots and experienced cramping pains. She then saw Respondent at the Winter Haven Hospital emergency room, but was told that nothing seemed wrong. Respondent advised her simply to go home, put her feet up, and rest. There were several other occasions during October, 1986, when C.W. experienced cramping and vaginal bleeding. She called Respondent each time to express her concerns, but was told simply to lie down, and keep her feet up. On October 22, 1986, C.W. and her husband visited Respondent for her third scheduled visit. No heartbeat was heard. Respondent again told C.W. that there was no cause for concern, the baby was just small and probably behind her pelvic bone. C.W. was presumably 14 weeks pregnant at this time, but Respondent's office records indicate that the fetus was decreasing in size, there was no weight gain, and no heartone. C.W. continued to experience pain and bleeding, sometimes accompanied by clots. She was not gaining weight, and had none of the other indications of pregnancy which she had experienced in her prior pregnancies. C.W. continued to express concern to Respondent, but his advice remained simply to lie down, and keep her feet up. In response to a five day episode of bleeding, C.W. saw Respondent in his office on November 12, 1986. Although she was 17 weeks pregnant at that time, Respondent's office records indicate a fetus 14 weeks in size. Respondent did not order any fetal viability tests, and there is no evidence in his office record that he considered any testing of the fetus. C.W. saw Respondent for her fourth scheduled visit on November 19, 1986, and, again, no fetal heartbeat was detected. She was still experiencing vaginal bleeding. Her uterus was only 10-12 weeks in size, although she was presumably 19 weeks pregnant at this time. C.W. was distraught, and expressed great concern to Respondent that she was presumably almost five months pregnant and no fetal heartbeat had ever been detected. C.W. demanded that Respondent do something. He then ordered a quantitative Beta-subunit Human Chorionic Gonadotropin blood test to determine her hormone level. On November 2l, 1986, Respondent called C.W. at her place of employment, and informed her that her hormone levels were extremely low, and that she might not have a viable pregnancy. He told her she should keep her next regularly scheduled appointment with him, but if she experienced any severe bleeding or cramping to call him. C.W. left work and became increasingly upset. She contacted him later on that same day for a more complete explanation of what she should expect. Respondent told her that the fetus was "reversing itself and was losing weight instead of gaining." C.W. was not informed by Respondent that the fetus was not viable, and she took his advice to mean that if she was extremely careful there was still a chance of carrying the pregnancy to term. Respondent admitted to the Petitioner's investigator, Jim Bates, that he knew the fetus was dead at this time, but he was trying to let nature take its course, and if she did not abort in two or three months, he would take the fetus. Because she was extremely upset and her friends were concerned about the advice she was receiving from the Respondent, an appointment with another obstetrician, Dr. Vincent Gatto, was made for C.W. by one of her friends. Dr. Gatto saw C.W. on or about November 21, 1986, and after examining her he immediately diagnosed her as having had a missed abortion. A sonogram confirmed this diagnosis. A dilation and curettage was performed on C.W., and subsequent pathological reports revealed remnants of an 8-week fetus. The medical records which Respondent maintained of his care and treatment of C.W. are incomplete and contain discrepancies concerning his evaluation of the patient. They do not reflect C.W.'s numerous telephone calls, or that she was increasingly upset over the course of her pregnancy. There is no delineation of a plan of treatment in these records, or any explanation of the type of treatment he was pursuing for her. There is no explanation or justification in these records of Respondent's failure to order a sonogram or test, other than the one Beta-subunit Human Chorionic Gonadotropin, for C.W., although she repeatedly reported vaginal bleeding and cramping, and there was a continuing inability to detect a fetal heartbeat. Respondent failed to carry out the correct tests on C.W., and therefore, he failed to make a correct diagnosis of missed abortion, or to treat her correctly. He allowed her to carry a dead fetus for almost two months. Retention of the products of a non-viable pregnancy can lead to several complications, including infection, blood clotting and psychological trauma. In fact, this experience caused C.W. severe emotional anguish. In his care and treatment of C.W., Respondent failed to meet the standard of care that is required of a physician practicing under similar conditions and circumstances.
Recommendation Based upon the foregoing, it is recommended that Florida Board of Medicine enter a Final Order suspending Respondent's license to practice medicine for a period of five years, and imposing an administrative fine of $3,000. DONE AND ENTERED this 21st day of August, 1989 in Tallahassee, Florida. DONALD D. CONN Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 Filed with the Clerk of the Division of Administrative Hearings this 21st day of August, 1989. APPENDIX (DOAH CASE NO. 88-4785) Rulings on the Petitioner's Proposed Findings of Fact: Adopted in Finding l. Adopted in Finding 2. Adopted in Finding 3. Adopted in Finding 4. Adopted in Finding 5. 6-7. Adopted in Finding 6. Adopted in Finding 7. Adopted in Finding 8. Adopted in Finding 9. Adopted in Finding 10. Adopted in Finding 11. Rejected as irrelevant. 14-17. Adopted in Finding 13. 18-21. Adopted in Finding 12. 22. Adopted in Finding 14. The Respondent did not file Proposed Findings of Fact. COPIES FURNISHED: Mary B. Radkins, Esquire Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, FL 32399-0792 Allen B. Erde, M.D. P. O. Box 1817 Winter Haven, FL 33883-1817 Allen B. Erde, M.D. 198 First Street, South Winter Haven, FL 33880 Dorothy Faircloth Executive Director Northwood Centre 1940 North Monroe Street Tallahassee, FL 32399-0792 Kenneth Easley, General Counsel Northwood Centre 1940 North Monroe Street Suite 60 Tallahassee, FL 32399-0729
The Issue At issue in this proceeding is whether Austin Tyler Durand, a minor, suffered an injury for which compensation should be awarded under the Florida Birth-Related Neurological Injury Compensation Plan.
Findings Of Fact Fundamental findings Camilla Durand is the mother and natural guardian of Austin Tyler Durand (Tyler), a minor. Tyler was born a live infant on September 5, 1992, at Memorial Hospital West, a hospital located in Pembroke Pines, Florida, and his birth weight was in excess of 2500 grams. Among the physicians providing obstetrical services during the birth of Tyler was Michael F. Augustino, M.D., who was, at all times material hereto, a participating physician in the Florida Birth-Related Neurological Injury Compensation Plan (the Plan), as defined by Section 766.302(7), Florida Statutes. Ms. Durand's antepartum course and Tyler's birth At or about 7:30 p.m., September 5, 1992, Ms. Durand presented to Memorial Hospital West complaining of contractions. At the time, her estimated due date was noted as September 7, 1992 (by ultrasound), and her antenatal course was without apparent complication. On presentation, contractions were noted as moderate, with a frequency of 3 to 5 minutes and a duration of 60 to 70 seconds. Examination revealed the membranes to be intact, with no apparent bleeding, and the cervix to be at 3 centimeters, effacement at 100 percent, and the fetus at station -1. External fetal monitor revealed a fetal heart tone (FHT) baseline of 140 to 150 beats per minute, with accelerations. Ms. Durand's obstetrician was advised of her progress, and she was admitted to labor and delivery. At about 9:45 a.m., Dr. Augustino evaluated Ms. Durand and noted no change on vaginal examination. He performed an AROM (artificial rupture of the membranes), noting clear fluid. FHT was stable and reactive. At about 10:00 a.m., at Ms. Durand's request, an epidural was placed. At about 10:12 a.m., Ms. Durand was started on Pitocin drip at 1 mu/min., to augment labor. At the time, her contractions were moderate, at 3 to 4 minutes apart and lasting for 60 to 70 seconds. FHT remained stable in the 140 beat per minute range, with good variability. The Pitocin was increased to 2 mu/min. at 10:35 a.m. At 11:30 a.m., vaginal examination revealed the cervix to be at 4 centimeters, effacement at 100 percent, and the fetus still at station -1. Pitocin was increased to 4 mu/min. At 11:30 a.m. Pitocin was increased to 5 mu/min; at 11:45 a.m. Pitocin was increased to 6 mu/min.; at 12:00 (noon) Pitocin was increased to 7 mu/min.; and at 12:15 p.m. Pitocin was increased to 8 mu/min. Vaginal examination at 12:30 p.m. revealed the cervix to be at 5 centimeters, effacement at 100 percent, and the fetus still at station -1. Contractions were noted as moderate to strong, at 3 to 4 minutes apart, and lasting for 60 seconds. FHT continued in the 140 beat per minute range, with good variability. At 1:15 p.m., Ms. Durand was noted to have moderate contractions every 2 to 3 minutes, lasting 40 to 50 seconds. Vaginal examination evidenced no progress. Pitocin was increased to 9, 10, and then 11 mu/min. Vaginal examination at 2:45 p.m. showed slight edema of the cervix, and no progress. FHT tone remained stable in the 150 beat per minute range, with good variability. At about 3:15 p.m., Ms. Durand was noted to have a temperature of 100.1, and she was accorded Tylenol. Vaginal examination at 3:45 p.m. noted no progress, but evidence of head molding. Vaginal culture was done, and antibiotics ordered. FHT remained stable in the 150 beat per minute range, with good variability. At 4:00 p.m., it was resolved to deliver by cesarean section for failure to progress and maternal temperature, and Pitocin was discontinued. FHT remained stable in the 150 beat per minute range, but with decreased variability. At about 4:30 p.m., Ms. Durand was noted to have a temperature of 101.2, and there continued to be no progress in cervical dilatation. The infant's head was described as molded and still poorly applied to the cervix. FHT remained stable in the 150 beat per minute range, but with decreased variability. Between 4:30 p.m. and 4:40 p.m., the fetal monitor was discontinued, and Ms. Durand was transported to the obstetrical operating room (OB/OR). Ms. Durand was noted on the table in the OB/OR at 4:45 p.m., the operation started at 5:00 p.m., and Tyler was delivered at 5:10 p.m. Nuchal cord x 3 was noted. Following delivery Tyler was accorded free flowing facial oxygen for two minutes. Apgars of 8 and 9 were assigned at one and five minutes by the neonatologist. The Apgar scores assigned to Tyler are a numerical expression of the condition of a newborn infant, and reflect the sum points gained on assessment of heart rate, respiratory effort, muscle tone, reflex irritation, and skin color, with each category being assigned a score ranging from the lowest score of 0 through a maximum score of 2. As noted, at one minute Tyler's Apgar score totalled 8, with heart rate, respiratory effort, muscle tone, and reflex irritation being graded at 2 each, and color being graded at 0. At five minutes, Tyler's Apgar score totalled 9, with heart rate, respiratory effort, muscle tone, and reflex irritation being graded at 2 each, and color being graded at 1. Tyler's Apgar scores were essentially normal, suggesting a vigorous infant, and he was transferred to the newborn nursery at 5:30 p.m. On admission to the nursery, Tyler's color was noted as pink, and his breathing as unlabored. Subsequent physical assessment was grossly normal, with the exception of a noted hypospandias (a developmental anomaly in the male in which the urethra opens on the underside of the penis or on the perineum3). However, given the maternal fever at delivery, blood cultures were ordered and Tyler was accorded a regimen of antibiotics to address the risk of sepsis. Tyler's newborn course was otherwise uneventful and he was discharged with his mother on September 8, 1992. Tyler's subsequent development Tyler received routine pediatric care following his discharge from the hospital, and his early infancy was essentially unremarkable, until about two years of age when the mother first became concerned about his development. Tyler was, however, a healthy child, except for pneumonia on two occasions, until on or shortly before February 5, 1995, when he was admitted to Memorial Hospital, Hollywood, Florida. The cause for Tyler's admission to Memorial Hospital, as well as the initial impression regarding his presentation, is stated in the admission summary, as follows: This is the first admission to any hospital in this two year four month old white male who had a temperature since the 3rd, he was seen by Dr. Budowski in the office and i[n] Dr. Samuels office as well and a screening strep test was shown to be positive. Medicine was given but mom did not give it, she took the child home. The patient apparently slept somewhat, mom gave Tylenol and the temperature went down. Apparently the child woke up about 10 o'clock in the evening time and low and behold, we are not sure if there was a spike in the fever but mom said she took the temperature and it was not elevated. Regardless there was a sweating episode, no cyanosis. He became stiff, turned to the right, did not become incontinent and his eyes were staring, this lasted for 10 seconds two episodes within a matter of a few minutes of each other and he was screaming as well before this started. This complex type of possible seizure. He did not turn cyanotic, however, she brought him to the hospital where he was then cared for and admitted. The patient did not have any seizure since that time. There has been no fever, no coughing, no distress, no rash, etc. He had no painful urination, no bowel problems. His appetite was fairly good up until that point. He was exposed from his cousins who had respiratory infections. PAST MEDICAL HISTORY: He was born at Memorial West 7 lbs, breast-fed for three months. He was born hypospadias, was in the hospital seven days because of a questionable sepsis, was delivered by cesarean section. Mom was treated with antibiotic and the baby was treated with antibiotics but apparently did well and there has been no trouble since. There is a history of infection, states that he has had several colds in the past and never a urinary tract infection. A month ago he had probable viral pneumonia treated as an outpatient proven by x-ray. No chicken pox. IMMUNIZATIONS: Up to date. No known allergies. His development history is somewhat delayed, his weight and height his mother says since six months of age has fallen off. He walked after a year of age, his speech is down, his receptive qualities are better than his expressive. He has very poor language skills. He runs stiff, clumsy- like, toes in and falls. He has had no tremors but his hand occasionally shakes when he is sucking his thumb, and his mom thinks that his milestones are delayed based on the children in the family. He is not a toe walker and has never had any other seizures. The patient is a poor eater and a picky eater. * * * PHYSICAL EXAMINATION: * * * NEUROLOGICAL: He walked with a little clumsiness again, this may be due to the chloral hydrate [administered for his CT scan], slight toeing in, no spasticity, no toe walking. 2+ reflexes, no tremors are present, no athetoid movements whatsoever. He did hold his balance pretty well, no clonus whatsoever. He is aware of his surroundings and place. There is an abnormal speech with poor communication skills. Gross hearing and vision seem to be normal. IMPRESSION: Seizure disorder. Seizures could be febrile. Definite positive strep test. Mild development delay ? the CT scan showed borderline lateral ventricle enlargement, could be upper limits of normal. Also speech/language delay, hypospadias, hyponutritution according to weight. As noted, Tyler's CT brain scan showed borderline lateral ventricle enlargement of uncertain significance. More specifically, the CT scan was reported to read, as follows: LATERAL VENTRICLES ARE SOMEWHAT PROMINENT FOR THIS AGE GROUP. THE REMAINDER OF THE VENTRICULAR SYSTEM AND BRAIN SUBSTANCE IS NORMAL. NO MASS NOR MIDLINE SHIFT. NO EXTRA-AXIAL COLLECTION. IMPRESSION: PROMINENT LATERAL VENTRICLES OF UNCERTAIN SIGNIFICANCE. SIGNIFICANCE SHOULD BE CORRELATED WITH THE PATIENT'S CLINICAL STATUS. A chest x-ray, also taken the day of admission (February 5, 1995), was read, as follows; THERE IS EXTENSIVE BILATERAL PERIHILAR INTERSTITIAL INFILTRATE AND BRONCHIAL WALL THICKENING. THERE IS ALSO EXTENSION OF PATCHY INFILTRATE INTO THE RIGHT LOWER LOBE SUGGESTING PNEUMONIA. THERE IS NO PLEURAL EFFUSION. THE MEDIASTINAL CONTOUR IS WITHIN NORMAL LIMITS. IMPRESSION: BILATERAL PERIHILAR DISEASE WITH EXTENSION OF PATCHY INFILTRATE INTO THE RIGHT LOWER LOBE SUGGESTING PNEUMONIA. An electroencephalogram (EEG) taken on February 9, 1995, was noted as "within normal limits for the age." Following his discharge from the hospital, Tyler was referred to Dr. Stuart B. Brown, a pediatric neurologist, to assess the cause of the incident which resulted in Tyler's hospitalization. Dr. Brown's impressions, based on his examination on February 10, 1995, are noted in his report (of February 15, 1995), as follows: The neurological examination revealed this child to be very, very apprehensive and shy. His gait was mildly wide based and unsteady and this was particularly true when he attempted to turn about. Sitting was normal as was crawling and he was able to stand from a sitting position without difficulty. Hand usage appeared to be normal and there was no evidence of striking intention tremor. Muscle tone was normal to decreased in the lower extremities and deep tendon reflexes were only plus one but obtainable and equal in all joint areas. Plantar reflexes were flexor bilaterally. Involuntary movements were not seen. Cranial nerve examination revealed full extraocular movements without nystagmus. The pupils were equal and reactive to light. Optokinetic nystagmus was symmetrical. Fundi were normal with regard to optic discs. Facial musculature appeared normal. He often seemed to have his mouth open but was noted to close it. Tongue appeared normal. Cry was lusty. Hearing appeared intact to tuning fork. The neck was supple and head control was normal. IMPRESSION: I think that this child had a breath holding-like vasovagal episode following being awakened suddenly from sleep causing a persistent screaming and then tonic posturing. We do not have any evidence clinically, by history, or electrically to suggest a seizure problem here. I am concerned however because the child is developmentally delayed from a speech standpoint where he still has basically a jargon speech and from a motor standpoint where he is ataxic. I am not sure as to the basis for this. He also seems to me to be excessively small in stature. I am going to review the MR scans of the brain In the meantime I would suggest getting a wrist x-ray for bone age along with a specific DNA test for fragile x and a chromosome analysis to see if there is any translocation. I would obtain a urine organic acid assay and a plasma amino acid assay and some thyroid studies. I am particularly concerned by the motor and speech problems and less concerned by these episodes which occurred recently. . . . The requested testing was done, and failed to reveal any abnormality. Pertinent to this case, Tyler was seen in neurology consultation on November 17, 1995, by Dr. Roberto F. Tuchman. After considering the perinatal and past medical history, family history, and the results of his neurologic examination, Dr. Tuchman summarized his impressions as follows: . . . we have a 3-year-old boy with developmental delays in language and motor function with ataxia and a tremor without any clear history of regression at this present time. His workup today has only been significant for an MRI showing some mild delay in myelination and we do not have the specific diagnosis to explain his present finding. I do think that we may want to do at least an alpha-fetoprotein for now and I would like to review the rest of his workup and see if I could come up with any further ideas. In addition I am referring him to Dr. Jean A. Cardi who is widely known pediatrist neurologist who is visiting us for the next three months. Once we get this information I will reassess and see if there is anything more that we need to do. . . . After reviewing the history and neurologic examination with Dr. Cardi, it was felt that Tyler "fit the group of children that have been termed cerebral palsy-ataxic type." Also pertinent to this case, Tyler was seen in neurologic consultation on December 28, 1995, by Dr. Robert F. Cullen, Jr. Dr. Cullen's impressions were, as follows: . . . Tyler is a 3-3 1/2 year-old lad with indeed a picture of ataxia, hyperreflexia and up-going toes. While indeed the terminology of an ataxic cerebral palsy might be appropriate I am concerned that he may indeed have the Angelman syndrome or Happy Puppet syndrome. He indeed has a very stiff and jerky gait. He has an abnormality of speech and has had seizures. What we are going to do now is try to get blood for the fish technique and look and see if he has abnormalities in the region of Q11-13 on chromosome 15. I think he should continue with physical, occupational, and speech therapy. I will have the MRI reviewed by Dr. Nolan Altman to see how delayed the myelin is . . . . Tyler's development and the efforts expended to identify the nature of his anomaly, are aptly summarized by Dr. Harvey S. Singer, who documented the results of his September 5, 1996, evaluation, as follows: REASON FOR VISIT: This was the first Pediatric Neurology Clinic visit for this 4-year-old white male referred for further evaluation of developmental delay. The patient is accompanied by his mother. HISTORY OF PRESENT ILLNESS: The patient was the product of a relatively normal pregnancy to a 29-year-old gravida-2, AB-1 mother who gained only 11 pounds during the pregnancy. She had a single exposure to x-ray but was wearing protective garb. Utrasound during the pregnancy showed normal fetal activity. The patient was delivered at 39 weeks by a cesarean section after prolonged labor. Birth weight was 7.5 pounds. Apgars were 8 and 9. Color was described as being slightly dusky and Austin was given oxygen via mask. Since Ms Durand developed a fever prior to delivery and was started on antibiotics, blood cultures were obtained, an LP was unsuccessful, and the patient was treated with antibiotics for 1 week. After discharge, he was breast-fed and was always described as being a poor feeder; in fact, he received breast feedings until the age of 2. The patient appeared to be doing reasonably well until approximately 6 months at which time decreased growth was noted. Subsequently, delays in motor and language areas became more apparent. He sat around 8 months, stood about 12 months, walked at 14 months, and talked at 18 months. Parents first became concerned at about 2 years; especially about delayed language development. There is no history of a loss of an ability once acquired. At present his vocabulary is approximately 75 words though most are not understandable. He conveys his desires pointing and using garbled speech. His receptive abilities exceed his expressive skills. He is able to follow commands and obtain objects. He has had prior formal evaluations: psychometric testing has shown him to be educably handicapped whereas speech and language evaluation showed him to have a level of 22 months and a motor development of 16-18 months. Two months ago he started a special education program but Ms Durand notes no definite improvements. Other described neurologic problems include episodes of breathholding beginning at the age of 2 months and resolving at approximately age 3 years. In addition, in 02/95, he had several seizures. In 01/95 he was hospitalized with pneumonia. One week later he had a temperature to 104 degrees and was continued on antibiotics. At the time of his seizures, he was reportedly afebrile both at home and when evaluated in the emergency ward, although later he did develop a fever. His episodes consisted of crying out, stiffening of all extremities and turning his head to the right, lasting for approximately 10 seconds. This then resolved but later recurred again though for a slightly shorter duration. The patient has had numerous neurologic evaluations by at least 5 pediatric neurologists. He was initially evaluated in 02/95 following the aforementioned seizure- like activity. He has had extensive testing which has included a normal EEG, a CT said to show possibly enlarged ventricles, and an MRI with decreased myelinization. Bone age was normal. A renal ultrasound was normal (obtained to further evaluate the patient's hypospadias). He has had a normal karyotype (46XY), negative DNA testing for fragile X, and negative FISH probes for Angelman's syndrome. He has also had negative urine organic acids, serum amino acids, thyroid screens, normal long chain fatty acids, normal alpha fetoprotein, normal vitamin E, and a serum lactate of 2.6 Thyroid stimulating hormone was slightly increased at 4.76 (normal 0.26 to 4.4), a slightly increased T3 of 2.2 (normal 0.8 to 2.0) and a normal T4. Previous diagnoses have included ataxia cerebral palsy as well as "etiology unknown." Review of systems: Shows short stature, hypospadias, esotropia, an episode of prolonged emesis (etiology undermined with normal laboratory evaluations), and pneumonia X2. Family history: Mother is age 33 in good health. Father is age 42, described as being an alcoholic. Mother's grandmother has hypertension. A maternal cousin is retarded with hearing deficits of unknown etiology. Mother has migraines and sinus problems and an uncle has learning problems. MAJOR FINDINGS: On physical examination, this is a small, thin, youngster in no acute distress. He prefers sitting in his stroller or else in his mother's lap. He follows commands. Vocabulary appears limited and many of his spoken words are indistinct, although some are appropriate and correct. Skin: No neurocutaneous phenomenon. Head: Head circumference was 50.5 cm (approximately the 60th percentile). At times he keeps his head held back. HEENT: The patient has a slightly dysmorphic appearance. He has squared off teeth that are widely spaced. Heart: Regular sinus rhythm. Lungs: Clear. Abdomen: No organomegaly. Extremities: No cyanosis or clubbing. Cranial nerves: The patient has an "A-pattern" esotropia. He tracks by using horizontal saccadic movements and prefers to follow an object by moving his head. To doll's maneuver, one is able to obtain full horizontal extraocular movements. The patient does have slight limitation of upgaze with greater downgaze capabilities. He is able to converge, has normal quick phases, and adequate gaze holding. He has slight ptosis bilaterally. There was no alteration of facial sensation. Corneal reflexes were present. The patient does have slightly decreased spontaneous facial movements. Hearing is grossly intact. Palate is midline. Gag is present. Tongue shows no fasciculations or atrophy. Sensation: grossly intact to touch and pin. Motor: Thin extremities, good strength. The patient has a wide based gait and walks with arms held in an extended upward fashion. In addition to being wide based, he also has some slight circumduction of the right lower extremity as well as a steppage-like component. He is flat footed. Genu recurvatum is present in the standing position. Passive movement shows hypotonia in both upper and lower extremities though there is variability during the exam, especially in the lower extremities. He has dysmetria bilaterally. He sits fairly steadily though with occasional periods of slight titubation. Reflexes were 2-3 in the lower extremities, 2+ in the upper extremities; no crossed adductors. Toes were equivocal though tending to be extensor. There were no frontal release signs. The patient's MRI scan was reviewed with neuroradiology and shows definite evidence of vermal aplasia, a thin corpus callosum and delayed myelination. ASSESSMENTS: This is a 4-year-old with a static encephalopathy [any degenerative disease of the brain] associated with cognitive and motor delays. Examination shows evidence for cerebellar, cranial nerve pathway, and long tract findings. Based upon his history, examination and MRI, I strongly favor a developmental brain disorder as the etiology of this patient's difficulties. As described, his MRI shows partial agenesis of the cerebellar vermis and posterior lobe, a thin corpus callosum, and delayed myelination. A partial or complete defect of the cerebellar vermis may occur sporatically or as a component of the Dandy Walker syndrome, the Dandy Walker varient, or Joubert syndrome. Joubert syndrome is an autosomal recessive inherited condition characterized by retinal dystrophy, oculomotor abnormalities, episodic hyperpnea, ataxia and mental retardation (Lewis et al Am J Med Gen 52: 419, 1994). Austin has a history of breath holding but lacks periods of hyperpnea which alternate with episodes of apnea. Most infants with this syndrome are hypotonic, reflexes can be exaggerated and virtually all are retarded. Adamsbaum et al have described vermal agenesis without a posterior fossa cyst or hemispheric abnormalities with clinical signs of oculomotor dysfunction and developmental delay (Ped Radiol 24: 543, 1994). No specific treatment is available for developmental disorders and ongoing rehabilitative services should be vigorously pursued. I have arranged for Austin to be evaluated in pediatric genetics by Dr. Michael Garrity. . . . Tyler was seen in consultation on September 6, 1996, by Dr. Garrity, who reported the results of his analysis as follows: . . . Of note, Austin has been seen in Miami Children's Hospital by neurology, ophthalmology, genetics, and has had an extensive work-up in the past. His work-up has not found a cause for his problems. His work-up included a chromosome analysis which was normal, a FISH analysis for the Angelman/Prader-Willi locus. This was also negative. He has had normal very long chain fatty acids, normal alpha-fetoprotein, normal plasma amino acids, normal urine organic acids, the latter showed some minor abnormalities, increased pyruvate acid, glutonic acid, and sebacic acid, this does not suggest any diagnostic patterns to me. He has had DNA analysis for Fragile X which was also normal. * * * My overall impression was that Austin had developmental delay, an abnormal neurological examination. By report an MRI of the brain showed a decreased cerebellum, however there was nothing in my examination to suggest a cause for this problem. In view of the minor abnormalities found previously in his urine organic acids, I repeated urine organic acids which were normal. Repeat plasma amino acids were also normal. Blood was taken for analysis of possible carbohydrate deficient glycoprotein syndrome. I am unable to find a record of this sample, and advise it be repeated. At the present time I do not have a specific diagnosis to explain Austin's problems. Ms. Durand had many questions about the cause of Austin's problems, and I indicated to her that there were many causes of cerebellar hypoplasia [incomplete development] including chromosome abnormalities, environmental and infectious exposures during pregnancy, some biochemical disorders, and also some specific genetic developmental syndromes. I indicated that Austin did not really fit any of these at present, and that without a specific diagnosis, it was difficult to give an exact recurrence risk. The dispute regarding compensability Pertinent to this case, coverage is afforded under the Plan when the claimant demonstrates, more likely than not, that the infant suffered an "injury to the brain . . . caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate post- delivery period in a hospital, which renders the infant permanently and substantially mentally and physically impaired." Sections 766.302(2) and 766.309(1)(a), Florida Statutes. Here, there is no dispute that Tyler suffered an anomaly in brain development that has resulted in permanent and substantial mental and physical impairment. What is subject to dispute or, stated differently, at issue, is the cause and timing (genesis) of Tyler's brain anomaly or, pertinent to these proceedings, whether the proof demonstrates, more likely than not, that his neurologic impairment resulted from 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," as opposed to some other genesis. With regard to such issue, Petitioner is of the view that Tyler's neurologic impairment is related to some event which occurred during the birth process. In contrast, Respondent is of the view that the proof is not consistent with brain injury having occurred during or immediately following birth and must, therefore, be attributable to another etiology (i.e., prenatal injury or a developmentally-based disorder). Respondent's view of the proof has merit. The genesis of Tyler's impairment To address the genesis of Tyler's neurologic impairment, the parties offered selected medical records and other documents relating to Ms. Durand's antepartum and intrapartum course, as well as Tyler's birth and subsequent development. Portions of those records have been addressed supra, and further portions will be discussed infra. Apart from such documents, Ms. Durand offered her lay observations, and Respondent offered the deposition testimony of Charles Kalstone, M.D., a physician board-certified in obstetrics. The medical records and other competent proof have been carefully considered. So considered, it must be concluded that the proof fails to demonstrate, more likely than not, that Tyler's neurologic impairment resulted from 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 so concluding, it is observed that not one of Tyler's treating physicians attributed the genesis of his impairment to any event which may have occurred during the course of labor, delivery, or resuscitation. Rather, to the extent any of his physicians expressed an opinion as to etiology, they favored a developmentally-based brain disorder as the cause of Tyler's presentation. The clinical evidence also fails to support the conclusion that Tyler's neurologic impairment resulted from an injury to the brain which occurred during the course of birth.4 In this regard, it is observed that the fetal heart rate was monitored by internal heart monitor until approximately 30 minutes before delivery, and detected no evidence of fetal hypoxia or trauma (whether by umbilical cord compression or otherwise), and Tyler's presentation at birth (with normal Apgar scores, suggesting a vigorous infant) and neonatal course (without evidence of injury or neurologic abnormality) were not consistent with an acutely acquired neurologic injury, and it is improbable that he could have experienced an acute injury during labor and delivery, or immediately thereafter, without evidencing any clinical symptoms of such damage. Conversely, the existence of a prenatally acquired, developmentally-based brain disorder would be consistent with Tyler's presentation at birth and subsequent development.
Findings Of Fact Khaleya Elle Bailey Jones was born on October 18, 2007, at Tallahassee Memorial Hospital in Tallahassee, Florida. Khaleya weighed 3,585 grams at birth. Donald Willis, M.D. (Dr. Willis), was requested by NICA to review the medical records for Khaleya, to determine whether an injury occurred in the course of labor, delivery, or resuscitation in the immediate post-delivery period in the hospital due to oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate post-delivery period. Dr. Willis described his findings as follows: Delivery was by spontaneous vaginal birth. Birth weight was 3,585 grams. The newborn was not depressed. Apgar scores were 9/9. No resuscitation was required at birth. The baby went to the normal nursery. Nursery admission exam gives a diagnosis of “Term Newborn.” Management recommendations were for routine care. The baby had an uneventful hospital course and was discharged home on DOL2. In an affidavit dated June 26, 2014, Dr. Willis opined as follows: In summary, pregnancy, labor and delivery were uncomplicated. The baby was not depressed at birth and had an uneventful newborn hospital course. Medical records do not suggest the baby suffered a birth related brain injury. There was no apparent obstetrical event that resulted in loss of oxygen or mechanical trauma to the baby’s brain during labor, delivery or the immediate postdelivery period. As such, it is my opinion that there was no oxygen deprivation or mechanical injury occurring in the course of labor, delivery or resuscitation in the immediate postdelivery period that resulted in loss of oxygen or mechanical injury to the baby’s brain or spinal cord. Accordingly, there was no causal event which would have rendered the baby permanently and substantially mentally and physically impaired as a result of same. A review of the file in this case reveals that there have been no expert opinions filed that are contrary to the opinion of Dr. Willis that there was no obstetrical event that resulted in loss of oxygen or mechanical injury to Khaleya’s brain or spinal cord. His opinion is credited.
The Issue At issue is whether Natalie Taylor (Natalie), a minor, qualifies for coverage under the Florida Birth-Related Neurological Injury Compensation Plan (Plan).
