Findings Of Fact Braylon Roberts was born on February 3, 2009, at St. Joseph’s Women’s Hospital located in Tampa, Florida. Braylon’s birth weight exceeded 2,500 grams. Donald Willis, M.D. (Dr. Willis), was requested by NICA to review the medical records for Braylon. On July 1, July 9, and August 18, 2014, Dr. Willis performed a medical records review and wrote medical reports. In an affidavit dated December 29, 2014, he summarized his records review and opined as follows: In summary, labor was induced at term with an uncomplicated spontaneous vaginal delivery. The newborn was not depressed and required no resuscitation after birth. Hospital course was uneventful until DOL 2 when seizure activity was noted. MRI was consistent with cerebral stroke. The baby suffered a cerebral stroke at some time on DOL 2. Medical history of a normal spontaneous vaginal birth with no newborn depression and a normal initial newborn hospital course, suggests the stroke was not due to oxygen deprivation or mechanical trauma during labor, delivery or in the immediate post-delivery period. 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 post-delivery period. The additional records do not change any of the opinions expressed in the letter of 07/01/2014. The FHR monitor tracing does not suggest fetal distress during labor. This would be in agreement with the previous opinion that the newborn stroke did not result from oxygen deprivation during labor. NICA retained Raymond J. Fernandez, M.D. (Dr. Fernandez), a pediatric neurologist, to examine Braylon and to review his medical records. Dr. Fernandez examined Braylon on October 6, 2014. In a medical report regarding his independent medical examination of Braylon, Dr. Fernandez opined as follows: Braylon has a subtle (very mild) right hemiparesis that is not causing substantial motor impairment at this time and it is not predicted not [sic] to cause substantial motor impairment in the future. Speech is mildly to moderately delayed, but improving and he is improving with regard to basic learning skills in his regular kindergarten classroom setting. The ultimate outcome with regard to more complicated learning is indeterminate at this time, but he should continue to improve with appropriate input from teachers and family members. Braylon’s neurological injury was due to an ischemic stroke in the distribution of a branch of the left middle cerebral artery. His neurological injury was not caused by oxygen deprivation or mechanical injury due to an obstetrical event during labor, delivery, or in the immediate post delivery of [sic] resuscitation. Dr. Fernandez confirmed his opinion in an affidavit dated January 7, 2015.1/ 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 apparent obstetrical event that resulted in loss of oxygen or mechanical trauma to the baby's brain during labor, delivery, or the immediate post- delivery period. Dr. Willis’ opinion is credited. There are no contrary expert opinions filed that are contrary to Dr. Fernandez’s opinion that although Braylon has a subtle (very mild) right hemiparesis, it is not causing, and is not predicted to cause, substantial motor impairment. Further, Dr. Fernandez also opined that Braylon’s neurological injury was not caused by oxygen deprivation or mechanical injury due to an obstetrical event during labor, delivery, or in the immediate post-delivery or resuscitation. Dr. Fernandez’s 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).
The Issue At issue is whether Nathan William Keeler a/k/a Nathan William Christian, a deceased minor, suffered an injury for which compensation should be awarded under the Florida Birth- Related Neurological Injury Compensation Plan.
Findings Of Fact Fundamental findings Nathan William Keeler a/k/a Nathan William Christian (Nathan) was the natural son of Mary L. Christian and Scott L. Keeler. He was born a live infant on July 22, 1994, at University Medical Center, a teaching hospital located in Jacksonville, Duval County, Florida, and his birth weight was in excess of 2,500 grams. Nathan died September 1, 1994, while still a resident at University Medical Center. The physicians providing obstetrical services during the birth of Nathan were Doctors Anita Chen and Maria Gregory, resident physicians in an approved training program, who were supervised by Edward H. Illions, M.D., a "participating physician" in the Florida Birth-Related Neurological Injury Compensation Plan. Consequently, each physician who provided obstetrical services during the birth of Nathan was a "participating physician" in the Plan. Sections 766.302(7) and 766.314(4)(c), Florida Statutes. Ms. Christian's antepartum course Ms. Christian's antepartum course was followed through the clinic at University Medical Center, with her first visit on April 22, 1994. At that time, Ms. Christian's history reflected that she was 22 years of age, having been born October 10, 1971, and was the mother of two sons. The first son was delivered vaginally in September 1990 at 40 weeks gestation, and the second son was delivered by cesarean section, with a breach presentation, in August 1993, three months premature. Although the nature of the incision used during the birth of her second child was not apparently known during her antepartum period, Ms. Christian's pregnancy was rated high risk and delivery of Nathan was proposed to be a repeat cesarean section. Subsequently, at the time of Nathan's delivery, it was disclosed that the prior cesarean section was accomplished with a vertical or classical incision. Ms. Christian failed to keep her next scheduled appointment at the clinic for April 29, 1994, but was seen on May 6, 1994. At the time, fetal gestational age was estimated at 26 weeks, fetal heart tone and movement were noted, and cervical examination revealed the cervix to be closed and effacement thick. No anomalies were noted. Ms. Christian's next scheduled appointments at the clinic for May 19 and June 14, 1994, were not kept, and she was next seen at or about 11:50 a.m., July 14, 1994, with complaints of "cramps in groin area which come and go," but not contractions, and no vaginal bleeding or rupture of the membranes was noted. Examination revealed a fetal heart tone in the 130 beat per minute range, with the cervix at 3 centimeters and effacement at 70 percent, and the fetus at station 0. Erroneously calculating the gestational age of the fetus at 31 weeks, the clinic, based on the impression of "advanced cervical dilation [with] probable contractions by history," referred Ms. Christian to labor and delivery for "monitoring and tocolysis if [she was positive for] contractions." Ms. Christian was admitted to labor and delivery at or about 12:10 a.m., July 14, 1994. At the time, the estimated gestational age of the fetus was correctly identified as 35.5 weeks, examination noted the cervix at 3 centimeters, effacement at 75 percent and the fetus at station 0, and external fetal monitoring revealed a fetal heart tone of 120-150 beats per minute, but no contractions. Concluding that Ms. Christian was not in labor, she was discharged to her home. Ms. Christian next presented at the clinic the morning of July 21, 1994, for a routine checkup. At the time, estimated gestational age was 36+ weeks, and the fetal heart tone was noted in the 130 beat per minute range. No complaints of contractions were voiced or noted; however, a vaginal examination was not given to assess the cervix, and Ms. Christian, after routine blood and urine workups, was sent home. At approximately 7:00 p.m. that evening, July 21, 1994, Ms. Christian suffered what she described as contractions at seven minutes apart. According to Ms. Christian, she telephoned the hospital when the contractions began, and was told not to come in until her contractions were "down to two to three minutes apart." In considering the advice accorded Ms. Christian by the hospital, it is worthy of note that labor is generally described as the process by which the fetus is expelled from the uterus through the vagina, and labor begins with the onset of regular uterine contractions, with resulting progressive effacement and dilation of the cervix, culminating with the expulsion or delivery of the infant and placenta. 2/ Frequently, during the last half of pregnancy and especially the last trimester, a women experiences contractions unassociated with labor, know as Braxton Hicks or false labor contractions. False labor contractions, contrasted with true labor (regular contractions, i.e., persistent, of increasing severity and frequency) typically cease when the woman lies down. Ms. Christian's contractions continued for 45 minutes to an hour, but after she lay down they stopped. At approximately 11:00 p.m., Ms. Christian was awakened with a sharp pain in the abdomen, and was taken by ambulance to University Medical Center where she was admitted at 11:40 p.m. with severe abdominal pain. Nathan's birth Following admission, Ms. Christian was "triaged" to the labor room. History revealed a previous cesarean section for preterm breach, cervical examination revealed the cervix at 3-4 centimeters, effacement at 50 percent and no presenting part, and physical examination revealed an extremely tender abdomen. 3/ Fetal heart rate was noted to be 60-70 beats per minute, and at or about 11:56 p.m., Ms. Christian was transferred to the operating room for an emergency caesarian birth due to fetal distress, with probable placental abruption. 4/ The obstetrical delivery record reveals that Ms. Christian was in the operating room at 11:57 p.m., and the incision was started at 12:04 a.m., July 22, 1994. The operative record reveals the following: OPERATIVE FINDINGS: The patient had a complete uterine rupture with rupture all of the way to the top of the fundus. There was noted to be a complete 100 [percent] abruption and an intact amniotic sac with the fetus floating in the abdomen. . . . DESCRIPTION OF PROCEDURE: The patient was taken emergently back to operating room [no.] 5 where she was placed in the supine position. Once again the ultrasound was laid on the abdomen which was tense and there was noted to be fetal heart tones in the 60s. The patient was quickly prepped and she was placed under general anesthesia with endotracheal tube intubation. A Foley catheter had been placed prior to her being taken to the operating room. A Pfannenstiel skin incision was made and this was carried down sharply to the fascia which was then incised in the midline. The incision was then extended with Mayo scissors and the rectus sheath was dissected off of the rectus muscles. The rectus muscles were then separated in the midline and there was noted to be blood directly under the peritoneum. Once the peritoneum was entered there was noted to be a minimal amount of blood in the abdomen and the amniotic sac was seen and contained clear fluid. The amniotic sac was then ruptured with hemostats and a hand was placed into the abdomen and the fetal head was gently delivered. There was noted to be nuchal cord times one which was released. The infant was then atraumatically delivered and the cord was clamped and cut and the infant was passed to the pediatricians in attendance. The infant had Apgars of 1, 3 and 5 and was taken to the neonatal intensive care unit intubated. The cord pH was noted to be 6.62 with a base excess of -26.7. The placenta was noted to be 100 [percent] abrupted. The uterus was then taken out of the abdominal cavity and placed onto the abdomen and it was noted to be totally ruptured from the lower uterine segment all of the way to the top of the fundus along what was assumed to be a previous, and confirmed later to be a previous classical cesarean incision. At that point there was noted to be excessive bleeding and the uterus was beyond repair. The decision was made at that point to perform a cesarean hysterectomy. . . . Postoperative diagnosis was fetal distress with uterine rupture and complete abruption of the placenta. Nathan was delivered at 12:06 a.m., July 22, 1994, at 36 weeks gestation, with a weight of 2600 grams. Upon delivery to the pediatrician team, Nathan was floppy and blue without any respiratory effort and was immediately intubated and chest compressions were initiated. Subsequently, UVC was inserted and plamanate, followed by sodium bicarb, was given. Color improved and Nathan, sill ambu bagged, was transferred by Cavitron to the neonatal intensive care unit at or about 12:25 a.m. As heretofore noted, his Apgar rating was 1 at one minute, 3 at five minutes, and 5 upon his transfer to the neonatal intensive care unit. Initial cord pH was noted to be 6.62, with a base excess of -26.7, reflective of severe acidosis. In sum, Nathan, upon delivery, evidenced classic symptoms of severe oxygen deprivation. Subsequent pathology of the uterus reported "transmural trophoblastic penetration, compatible with placenta percreta." Such assessment reflects the absence of a cleavage plane (decidua) between the placenta and the uterine wall, and the presence of a placenta that has grown through the muscle wall of the uterus to the outer surface of the uterus. Where, as here, a scar exists from a prior uterine incision, such condition can substantially weaken the scar, with resultant uterine rupture and placental abruption. Such rupture may occur with or without uterine contractions and, consequently, before or during labor. As of September 1, 1994, Nathan weighed 3720 grams and his vital signs were stable; however, he was unresponsive to his environment, had no purposeful movements, had bilateral clonus, tight extremities and scattered roles, required frequent suctioning for secretions, and continued to require positive ventilator support. Consequently, there apparently being no reasonable alternative, Nathan "was withdrawn from medical support . . . and was sedated with morphine prior to extubating from positive pressure ventilation," and expired at 12:53 p.m., September 1, 1994. Given the proof, it is apparent that Nathan suffered perinatal asphyxia, secondary to placental abruption, with resulting hypoxic ischemic encephalopathy and permanent and substantial mental and physical impairment. Consequently, consistent with the parties' stipulation at hearing, the proof demonstrates that Nathan suffered an injury to his brain caused by oxygen deprivation that rendered him permanently and substantially mentally and physically impaired. Compensability of the claim In this case, NICA does not dispute and the record demonstrates, that Nathan suffered an injury to his brain caused by oxygen deprivation, secondary to placental abruption, which rendered him permanently and substantially mentally and physically impaired. Rather, NICA opposes coverage based on its contention that Nathan's injury resulted from uterine rupture, with placental abruption, that occurred when Ms. Christian was not in labor or, stated differently, before labor, delivery or resuscitation in the hospital. Where, as here, the proof demonstrates that the infant suffered an injury to the brain caused by oxygen deprivation that rendered him permanently and substantially mentally and physically impaired, the petitioners/claimants are entitled to the benefit of a rebuttable presumption that the injury is a "birth-related neurological injury," as defined by the Plan. Section 766.309(1)(a), Florida Statutes. Under the circumstances of this case, the presumption is that Nathan's injury occurred "in the course of labor, delivery or resuscitation in the immediate post-delivery period in a hospital." Consequently, resolution of this case resolves itself to whether NICA has produced sufficient evidence to contradict or rebut the presumption and, if so, whether absent the aid of such presumption the record demonstrates, more likely than not, that Nathan's injury arose during that period. 5/ Regarding the timing and cause of Nathan's injury, the operative report, as heretofore noted, revealed an intact amniotic sac, containing the fetus, floating outside the uterus in the abdominal cavity, and a rupture of the uterus, at the site of the previous caesarian section, with complete abruption (separation) of the placenta. Given the proof, the rupture of the uterus and abruption of the placenta most likely occurred at or about 11:00 p.m., when Ms. Christian was awakened with the sharp pain in her abdomen. Upon abruption, Nathan's source of oxygen was terminated, leading over time to severe oxygen deprivation, with resultant brain damage and neurologic impairment. 6/ In the opinion of Charles Kalstone, M.D., a board certified obstetrician, the injury Nathan received to his brain, incident to oxygen deprivation, occurred prior to Ms. Christian's admission to the hospital and Nathan's delivery. Supportive of such opinion is the substantial time lapse from placental abruption until admission to the hospital, the fixed low heart rate of the infant upon admission, the infant's delivery with an Apgar of one, which is consistent with a premorbid or almost dead state, and the severe acidosis found to be present at birth. Given the proof, Dr. Kalstone's opinion is credited. 7/ It was further Dr. Kalstone's opinion that Ms. Christian was never in labor. Supportive of such opinion are Ms. Christian's antepartum course and the delivery records. Regarding Ms. Christian's antepartum course, it is first observed that Ms. Christian's examination on July 14, 1994, is consistent with cervical dilation prior to labor. In this regard, it is noted that Ms. Christian, at 35.5 weeks, complained of cramps and not contractions. Moreover, while the cervix was described as three centimeters dilated and 70- 75 percent effaced, external fetal monitoring reflected no contractions and she was noted as not being in labor. When Ms. Christian next appeared for a routine visit on the morning of July 21, 1994, she again did not complain of any contractions, and following routine blood and urine work she was sent home. Apparently, nothing unusual occurred thereafter until approximately 7:00 p.m., when Ms. Christian experienced contractions at seven minute intervals for approximately 45 minutes to one hour. Those contractions ceased, however, when Ms. Christian lay down, consistent with Braxton Hicks or "false labor" contractions, as opposed to contractions associated with labor. No contractions were noted thereafter and the evening was apparently uneventful until approximately 11:00 p.m., when Ms. Christian was awakened with a sharp pain in the abdomen which, as heretofore noted, was occasioned by the rupture of her uterus. Following admission to the hospital at 11:40 p.m., examination revealed the cervix at 3-4 centimeters and 50 percent effaced, essentially the same and certainly no greater than the examination of July 14, 1994; an observation inconsistent with the presence of labor. Considering the proof, Dr. Kalstone's opinion is credited, and it must be found that the proof fails to support the conclusion that the injury Nathan suffered occurred in the course of labor. To the contrary, the proof demonstrates, more likely than not, that Ms. Christian was not in labor. 8/
The Issue Should discipline be imposed against Respondent's license to practice medicine for violation of Section 458.331(1)(t), Florida Statutes (2003)?
Findings Of Fact Stipulated Facts Petitioner is the state department charged with the regulation of the practice of medicine pursuant to Chapter 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 458, Florida Statutes. Respondent is Michael D. Fox, M.D. Respondent is board certified in obstetrics and gynecology. Respondent is a licensed medical doctor in the State of Florida having been issued license ME 66312. Respondent's address is 3627 University Boulevard, South, Suite 200, Jacksonville, Florida 32216-4211. At all times material to this complaint, Respondent provided professional services as an employee of North Florida Gynecologic Specialists in Jacksonville, Florida. On or about September 26, 2003, Patient T.D. presented to Respondent with a history of worsening pelvic pain and abnormal menstrual bleeding. On or about October 6, 2003, Respondent and Patient T.D. agreed that Patient T.D. would undergo a hysterectomy. On or about October 22, 2003, during a pre-operative examination, Respondent ordered pre-operative lab studies, including a urine pregnancy test, for Patient T.D. On or about October 27, 2003, Respondent performed a total abdominal hysterectomy on Patient T.D. During Patient T.D.'s hysterectomy, Respondent took a specimen from Patient T.D., which was sent to pathology for evaluation. On or about October 29, 2003, a microscopic examination of the surgical specimen was performed that revealed Patient T.D. was pregnant at the time Respondent performed the hysterectomy on Patient T.D. Respondent did not ascertain the correct results of Patient T.D.'s pre-operative pregnancy test prior to performing the October 27, 2003, hysterectomy on Patient T.D. Respondent's Care of Patient T.D. Respondent attended medical school at the University of Alabama, Birmingham, Alabama. He did a four-year residency in obstetrics and gynecology (ob/gyn) in Jackson, Mississippi, and a two-year sub-specialty fellowship in reproductive endochrinology in Lexington, Kentucky. He is board-certified in reproductive endochrinology and ob/gyn. At present his specialty is reproductive endochrinology. Respondent has experience in performing hysterectomies and the pre-operative evaluations associated with those surgeries. Respondent does 30 to 40 hysterectomies a year. That number represented his experience in 2003. The principal reason for performing hysterectomies in his practice, is associated with sub-specialty interests, surgery for endometriosis and adenomyosis, a co-disease with endometriosis. Respondent has privileges to practice in hospitals in the Jacksonville, Florida area. In particular, he has privileges at St. Vincent's, St. Luke's, Baptist, Baptist Beaches, Memorial and Shands hospitals. He performs surgeries in all those hospitals. The hospitals where Respondent practices have computer systems that allow access to laboratory records and other forms of information associated with patient care. Although he has access to the computer systems in the facilities, his routine is to obtain laboratory information in the hospital setting from other persons involved in the patient care. He asks those persons to find out the information for him and report the finding(s). Respondent would have access to the patient hospital record, as well as a source for obtaining laboratory information. Respondent routinely looks at the patient hospital record in preparing for surgery. Concerning Patient T.D., the subject of this proceeding, when seen by Respondent she was described as a young female, of child-bearing age who presented with chronic pain. She had pain with periods which Respondent found to be characteristic of adenomyosis. She had pre-cycle pain approximately a week prior to her menses, another characteristic of adenomyosis. The patient had irregular bleeding that is an indication of adenomyosis. The patient was found to have an enlarged uterus, the primary source of her pain on the examination. This visit with Respondent, that formed the basis for his impression, took place on September 26, 2003. On the initial visit Respondent also obtained a history consistent with endochrine disorder causing irregular cycles. In the patient's case, the cycles extended as much as 60 days in relation to her periods. Based upon his initial impression, Respondent did not find evidence that Patient T.D. was pregnant. The patient told Respondent that she had no desire for fertility. At that time, she did not report having a partner, nor did she indicate that she was sexually active. To further evaluate the Patient T.D.'s condition and complaints, Respondent ordered an ultrasound test. That study was performed on October 2, 2003, and a gynecological ultrasound report rendered. Based upon the report, Respondent held to the view that the report showed evidence of adenomyosis. There was a mild and moderate enlargement of the uterus, which Respondent found to be consistent with adenomyosis. The patient had had a prior pregnancy and delivery and Respondent found the depiction on the ultrasound of a mild enlargement of the uterus consistent with the prior pregnancy and delivery. On their next visit, Respondent discussed the choice of a hysterectomy or some other form of surgery that did not involve a hysterectomy, to treat the endometriosis and relieve her symptoms. That visit took place on October 6, 2003. On October 22, 2003, Respondent met the patient again. He reviewed the details of what he believed was the underlying disease and potential treatments in discussion with the patient. The patient indicated that she wanted to proceed with the hysterectomy. That choice having been made, the surgery was discussed between the patient and Respondent and the necessary paperwork was started to arrange for the surgery in the hospital. When preparing for surgery Respondent ordered a pregnancy test to verify whether the patient was pregnant or not. The nature of the test was a urine pregnancy test under Respondent's preoperative orders given October 22, 2003. The specimen was collected on October 22, 2003, and received by Memorial Hospital (Memorial), Jacksonville, Florida, where the hysterectomy was to be performed. The test result was positive for pregnancy. The point in time that the result was revealed to Respondent will be discussed beyond this reference to the result. On October 27, 2003, Respondent began his surgery cases at Memorial at 7:30 a.m. On that date there was no indication in the patient record or chart maintained in his office practice that reflected information concerning the pregnancy test result, nor was that information found in the hospital chart related to Patient T.D. Absent the information, Respondent testified that he asked the circulating nurse at Memorial about the result of the pregnancy test. That was Tracy Lloyd, R.N. According to Respondent, the nurse went away to check the result and as Respondent describes "subsequently told me it was negative." No further effort was made by Respondent to confirm the oral report that Respondent says was made by the nurse. Respondent did not document the results of Patient T.D.'s pre-operative pregnancy test in the medical record. It was not his habit to write that type of a pre-operative note. Respondent testified that Ms. Lloyd told him about the pregnancy test results while in the holding area in the presence of the patient. Respondent commented that his question to the nurse would have been "What are the results of the pregnancy test?"1/ Aside from the results of the pregnancy test, nothing in the patient's condition, known to Respondent, led him to believe that the patient was pregnant. When the laparoscopic surgery commenced, Respondent did not perform an examination of the patient under anesthesia, given his recent examination of the patient in his office and the results of the ultrasound. Moreover, Respondent does not believe that such an examination under anesthesia would reveal anything other than the adenomyosis and the endometriosis which conformed to his preoperative diagnosis. On that subject, the later examination of the specimen on October 29, 2003, revealed that Patient T.D. had an early pregnancy, estimated as 4 to 5 weeks. In Respondent's opinion, in a 4-to 5-week pregnancy, the uterus would not normally achieve the size of a uterus that was reported on the ultrasound as mildly enlarged, not pregnant. Mildly enlarged refers to a 6 to 8 weeks' pregnancy. Respondent expected to see an enlarged uterus because of the adenomyosis which could be anticipated to cause an inflammatory response in the wall of the uterus, softening the uterus and giving it an appearance that would be similar to an early pregnancy. The rounded globular description of the findings during surgery were consistent with the expectations in addressing cases involving adenomyosis, according to Respondent. Returning to the surgical specimen obtained in Patient T.D.'s case, it was examined through surgical pathology conducted by Robert E. Barnes, M.D. A report was rendered. The report explains that in the examination of the specimen, the endometrium, "gestational endometrium with products of conception" were present. This was the finding related to Patient T.D.'s pregnancy. Dr. Barnes, is a board-certified pathologist in anatomic and clinical pathology. He describes his findings pertaining to Patient T.D., the gestational endometrium with products of conception, as referring to an early embryo, the endometrium showing changes associated with pregnancy. In his opinion the pregnancy was between 10 and 16 days following conception. When Dr. Barnes contacted Respondent on October 29, 2003, to advise of his findings in the pathology. It was a brief conversation and he does not recall the details. After the revelation concerning the pathology, Respondent's office staff found the information concerning the results of the urine pregnancy test in the hospital chart retained in the computer at Memorial. This finding was made around November 4, 2003. In a section within the report on the pregnancy test it refers to the "Result" and underneath that, the word "POSITIVE" is entered referring to pregnancy. When it was discovered that the hysterectomy had been performed while the Patient T.D. was pregnant, at her post- surgery scheduled office visit, a discussion was held with the patient concerning the "checks and balances" in place to avoid the problem. That refers to the surgery at a time the patient was pregnant. Respondent talked to the patient about counseling, or something similar, given the outcome in the case. As a result of the error, steps were taken within Memorial to address this circumstance. The Respondent and the Memorial Department of OB/GYN made changes, by requiring a pre- operative pregnancy test as protocol, that established a urine pregnancy test within 72 hours of surgery. That test would be performed by the nurses in the holding area. Respondent now orders a blood pregnancy test which is a more sensitive test to determine pregnancy. Expert Opinion Jose Cortes, M.D., is board-certified in ob/gyn, licensed to practice in Florida. He was recognized as a expert in ob/gyn for purposes of expressing his opinion about the care Respondent provided Patient T.D. Dr. Cortes has done hysterectomies in his practice, as recent as June 2006. He was called upon to render an opinion concerning the care Respondent provided Patient T.D. involving her hysterectomy. He had access to material concerning her care involved with this case. Dr. Cortes' impression of Respondent's medical treatment of the patient in the beginning, was that it was adequate and correct, with the proper evaluation performed and an appropriate decision made for surgery. Dr. Cortes expressed the opinion that in performing a hysterectomy on a woman who is of child-bearing age, which Patient T.D. was, a physician should order a pre-operative pregnancy test. In reviewing Patient T.D.'s records Dr. Cortes did not find a record documenting that the pregnancy test was ascertained by Respondent, referring to the test results. In his experience the results of the preoperative tests would be reflected in the patient's medical records as a matter of custom. Respondent, according to Dr. Cortes, could have obtained the results of the pre-operative pregnancy test for Patient T.D. by a fax to his office, a copy obtained through a computer, laboratory printouts sent to Respondent's office, and a copy of the pre-operative laboratory results obtained by the hospital placed in its medical record. Dr. Cortes stated the position that an experienced ob/gyn, and Respondent fits that category, could reasonably be expected to rely upon an oral report from a nurse as to the results of the pregnancy test, before entering the operating room, in the area of the pre-operative alcove as the patient is being interviewed by the physician. Dr. Cortes goes on to explain that if the conversation with the nurse in the presence of the patient was in the operating room holding area, then the pregnancy test results would have to have been documented in the patient chart to find the oral report acceptable. Those test results as reported would have had to be entered by the physician in the patient chart to meet the standard of care upon the oral report.2/ Later on, Dr. Cortes in his testimony seems to subscribe to the view that an oral report by the nurse as to the pregnancy test results would meet the standard of care, assuming that the Respondent in this case was provided an oral report. In the testimony at hearing, Dr. Cortes also said that obtaining an oral report or verbal report on test results, in an emergency situation, would meet the standard of care. By contrast, in elective surgery, such as that being performed on Patient T.D., it would be such that there was ample time to review a chart and laboratory studies before the patient was brought into the surgical suite. Generally stated, Dr. Cortes accepts that physicians frequently rely upon oral information imparted by nurses in performing surgeries, be they elective or emergent, but without an oral report this concession is not important. Regardless of the pre-conditions for Respondent to receive and rely on an oral report of the results of the pregnancy test, without an oral report, there being no other basis for Respondent's knowledge of the pregnancy test results, it was below standards to proceed with the hysterectomy. This view is taken from Dr. Cortes' testimony. Dr. Cortes expressed the opinion that it was below the standard of care to not ascertain the results of the patient's pre-operative pregnancy test prior to performing a non-emergent hysterectomy, that is an elective hysterectomy. Dr. Cortes expressed the opinion that it was below the standard of care for Respondent to perform a hysterectomy on Patient T.D. while she was pregnant in an elective setting. In addition to the results of the pregnancy test, Dr. Cortes believes that Respondent had other opportunities to detect the pregnancy, including an examination of the patient while she was under anesthesia during the surgery, and would have allowed a comparison of the results at the time of surgery against previous examinations that Respondent had performed on the patient. In referring to the previous examinations compared to an examination under anesthesia, this included the results of the ultrasound performed on October 2, 2003. Dr. Cortes does agree that the underlying condition visualized under anesthesia could be associated with prior pregnancy or the pre-operative diagnosis of adenomyosis. Dr. Cortes believes that Respondent's medical records, in the context of what could have been found upon an examination under anesthesia during the surgery, could be consistent with a possible pregnancy. A change seen in the pelvic examination at surgery would create an opportunity to evaluate and raise in the Respondent's mind any doubt concerning pregnancy. A slight increase in the size of the uterus between September 26, 2003, and October 27, 2003, is what is being referred to, promoting clinical judgment about possible pregnancy. Bryan Cowen, M.D. specializes in ob/gyn and reproductive endochrinology. He practices at the University of Mississippi in Jackson, Mississippi. He is a professor and chair in the Department of OB/GYN and has been for five years. He has been affiliated with the University of Mississippi for 24 years. He did his undergraduate work at the University of Colorado in Boulder, Colorado, and attended medical school in Denver, Colorado. Dr. Cowen is licensed to practice medicine in Mississippi and is board-certified. Dr. Cowen has performed a number of hysterectomies during his career. Dr. Cowen is familiar with the standard of care applicable for physicians such as Respondent, in the evaluation of patients suspected of endometriosis and adenomyosis and the considerations for treatment by hysterectomy. He is also familiar with the standard of care in relation to pre-operative testing and the associated duties of physicians when ordering such tests. In preparing to testify in this case, Dr. Cowen examined the Memorial medical records, Respondent's office records, and the depositions of Respondent, Dr. Freeman, Dr. Widrich, Dr. Barnes, and Dr. Cortes. With this information in mind, Dr. Cowen was able to provide an opinion concerning the standard of care in relation to the treatment provided by Respondent to Patient T.D. That opinion was that Respondent did not breach the standard of care in that he met due diligence in the process by the pre-operative laboratory-ordered, and pre- operative evaluation and assessment. Speaking to the September 26, 2003, office visit, Dr. Cowen saw nothing on the physical examination to indicate to him that Patient T.D. was pregnant. Concerning the ultrasound that was conducted on October 2, 2003, Dr. Cowen's opinion is that Respondent's assessment that Patient T.D. had adenomyosis based upon presentation, was confirmed by the ultrasound, the overall impression being that the Patient T.D. was not pregnant at that time. The further visit by the patient prior to the hysterectomy did not reveal anything in the history or physical examination that would suggest that Patient T.D. was pregnant, according to Dr. Cowen. On October 22, 2003, the pregnancy test was ordered by Respondent. The arrangement of ordering the test, sending the patient for pre-operative evaluation and laboratory tests is a common practice in Dr. Cowen's experience. In the instance where Respondent did not get a call from the pre-admission testing as to any abnormal results in the pregnancy test, and no report reflecting in the patient chart that the results were normal, Dr. Cowen commented on the need to check the laboratory results before taking the patient into the operating room. Based on Dr. Cowen's experience, there was no necessity to personally lay eyes on the test results to ascertain those results. He recognizes that his hospital may be different from Memorial in its expectations but he believes that Respondent followed Memorial's policy in accepting the report of a nurse as to the results of the pregnancy test. Dr. Cowen's opinion relies upon the factual predicate that Respondent was told by a nurse that the pregnancy test was negative, to the extent that is not true, and it has not been found as a fact, his opinion is without foundation. Further, Dr. Cowen believes that in the setting where surgery is being performed in other than an emergency, it is a sufficient practice to rely upon an oral report of a nurse concerning laboratory results, such as the outcome in the pregnancy test for Patient T.D. In his experience he has relied upon nurses to report both in an emergent and non-emergent settings. He goes on to describe how those reports come back to the medical records and the physician signs off, which did not occur in this case. Dr. Cowen was asked to express his opinion about the value of an examination under anesthesia as an assist to understanding the underlying condition of the Patient T.D. Dr. Cowen does not believe that this would provide additional information. In his experience most physicians have abandoned examinations under anesthesia. If a better insight is needed an ultrasound is the best choice. To Dr. Cowen, an examination under anesthesia does not relate to standard of care, it is in relation to an individual practitioner's protocol. An ultrasound used in this case, a transvaginal ultrasound, may have shown the gestational sack at the time of the hysterectomy but proceeding on the basis that a negative pregnancy test had been established and other findings during the course of the operation, as well as the preoperative record, would not indicate the necessity for an ultrasound in this case, at that time, the place in time where the hysterectomy was being performed. Dr. Cowen did not find anything in the intra-operative findings that would suggest to Respondent that the Patient T.D. was pregnant. Overall Dr. Cowen believes that Respondent met the standard of care in addressing the case of Patient T.D., who probably had polycystic ovarian disease, irregular cycles, was without a sexual partner by history, used condoms for contraception, had an ultrasound that confirmed a slightly enlarged uterus and had symptoms compatible with adenomyosis or endometriosis. Respondent discussed the treatment options, made an appropriate pre-operative evaluation, learned that the lab results for pregnancy were negative (an erroneous assumption), and therefore, he met the standard of care, according to Dr. Cowen. Ultimately, Dr. Cowen believes that it is essential to determine whether a patient is pregnant prior to performing a non-emergent/elective hysterectomy, which was not done here. Wyatt McNeill, M.D., testified. He is an ob/gyn practicing in Jacksonville, Florida, who in the past has had privileges at Memorial. He has performed hysterectomies at that facility. Dr. McNeill graduated from Florida State University. He graduated from the University of Miami Medical School. He is licensed in the state of Florida and is board-certified in ob/gyn. Dr. McNeill is familiar with the standard of care in relation to preoperative laboratory work done before a hysterectomy. Dr. McNeill is familiar with the standard of care applicable to Respondent in the evaluation of Patient T.D. for hysterectomy, knowing after the fact that the patient was found to be pregnant. To familiarize himself with the facts of this case, Dr. McNeill examined the hospital records of Memorial, Respondent's office records, various depositions, to include that of Dr. Cortes and the anesthesiologist and pathologist, before providing testimony. He also examined the testimony of the nurses involved in the care before offering his opinions. Concerning the patient history, objective and subjective evidence available, Dr. McNeill did not believe that there was anything to suggest that Patient T.D. was pregnant. In particular, Dr. McNeill comments on the history and physical done by Respondent, counseling, laboratory evaluation, and the decision beyond that to proceed with the surgery. Dr. McNeill found the ultrasound results consistent with a patient, who by history had a previous child and had the complaints expressed in the report concerning the September 26, 2003, visit with Respondent. Nothing in the ultrasound results compared to the findings in the operative report indicated to Dr. McNeill that the patient needed to be examined under anesthesia. The use of the examination under anesthesia is a training regimne for residents and students, in his experience. It has no utility beyond that application, in Dr. McNeill's opinion. Dr. McNeill believes that an oral report of the results of the pregnancy test meets the standard of care. As with others, Dr. McNeill assumes that Respondent was told the test results, which is not found. There was no further duty by Respondent to investigate those results having been told. In Dr. McNeill's opinion, the test results are either positive or negative, they are highly accurate. A negative test result means that the patient is not pregnant. No further duty is established beyond that realization, according to Dr. McNeill. In summary, there is no disagreement among the experts that Respondent is expected to ascertain the results of the preoperative pregnancy test before performing the hysterectomy and it would be inappropriate to perform the hysterectomy without those results. Respondent does not disagree with that perception. Conceptually, having considered the testimony of Respondent and the experts, it would be acceptable to proceed on an oral report, if one had been made, a report that the pregnancy test was negative.3/ Otherwise, the physical examination of the patient prior to surgery, the results of the ultrasound, and the observations intra-operatively made by Respondent did not indicate that the patient was pregnant. There was no necessity to make an examination under anesthesia. Even if made, it would not necessarily lead to the conclusion that the patient was pregnant, taking into account other information known by Respondent. Mitigation/Aggravation The outcome here was that the patient underwent a hysterectomy when she was pregnant, an adverse result. There is no indication that Respondent has ever been disciplined in Florida or other jurisdictions while practicing medicine.
Recommendation Based upon the findings of facts found and the conclusions, it is RECOMMENDED: That a final order be entered finding Respondent in violation of Section 458.331(1)(t), Florida Statutes (2003), and imposing an administrative fine of $10,000.00, requiring Respondent to take a course on Risk Management for physicians, and issuing a letter of reprimand. DONE AND ENTERED this 22nd day of June, 2007, in Tallahassee, Leon County, Florida. S CHARLES C. ADAMS 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 22nd day of June, 2007.
The Issue The issue in this case is whether Jeffrey D’Angelo, Jr. (Jeffrey), suffered a birth-related neurological injury as defined by section 766.302(2), Florida Statutes (2014), for which compensation should be awarded under the Florida Birth- Related Neurological Injury Compensation Plan (Plan).
Findings Of Fact On February 22, 2014, in her 37th week of pregnancy, Petitioner, Katis D’Angelo, had a spontaneous rupture of her membranes. She presented to Bayfront and, at approximately 11:00 p.m., was evaluated in the labor suite. Upon initial examination, her cervix was noted to be “1 cm dilated, 50 percent effaced with the vertex at a -2 station.” The fetus’s heart tones were normal; however, Mrs. D’Angelo was not having an active labor pattern. Accordingly, Mrs. D’Angelo was admitted to the hospital. Dr. Dieffenbach had been Mrs. D’Angelo’s obstetrician throughout her pregnancy and, upon admission to Bayfront, was the primary and attending obstetrician. To assist in the progression of her labor, Dr. Dieffenbach ordered a low dose of Pitocin. Mrs. D’Angelo’s labor progressed and her cervix dilated to about five centimeters; however, it “got hung up for about 5 hours.” She was reexamined about an hour later with no changes noted. Due to her failure to progress, Dr. Dieffenbach recommended a Cesarean section delivery. Dr. Dieffenbach’s Clinical and Operative Notes provide, in pertinent part, as follows: CLINICAL NOTE: . . . At this point, cesarean delivery was recommended. Risks were explained and accepted. The labor was dysfunctional. Pitocin was up to about 14 milliunits. The fetal heart tones were in the normal range, but failed to show a great deal of variability. No decelerations were noted. Fluids were changed to D5 and Ringers to see if that would help stimulate the baby. OPERATIVE NOTE: . . . Uterine incision was extended laterally by stretching. The baby was noted to be in a ROT position. The infant was LGA, weighing 7 pounds 14 ounces at 37 weeks. The extraction was difficult. This was a male weighing 7 pounds 14 ounces, 3575 grams. Apgars were 2, 6, and 8. The infant was noted to have cord wrapped around the legs with several loops and also around the abdomen, possibly accounting for the fetal heart rate changes. The nares and orpharynx were suctioned with bulb syringe. Cord was clamped and severed. The infant was given to the nurse for further care at the isolette . . . . Both mother and baby did well. The baby is currently in the NICU, stable. Jeffrey was born at 1:52 p.m., on February 23, 2014. At delivery, he was noted to be “depressed.” At one minute of life, Jeffrey’s Apgar score was a 2.1/ A Neonatal Intensive Care Unit (NICU) Registered Nurse (RN) was requested to provide assistance in the operating room and the RN arrived within four minutes. Due to his depressed state, resuscitative efforts were required in the first several minutes of life. These efforts included positive pressure ventilation (for five minutes), oxygen, and chest compressions for 30 seconds. It appears the resuscitative efforts were administered by the respiratory therapist and operating room nurse prior to the NICU RN’s arrival.2/ The NICU RN documented that, upon arrival, Jeffrey had poor color and tone. By his tenth minute of life, Jeffrey had responded well to the oxygen, his color had improved, and he had spontaneously cried. At 2:10 p.m., Jeffrey was transitioned and admitted to the Bayfront NICU. At the NICU, Jeffrey was noted to have decreased tone, facial bruising, petechiae, and a low blood glucose level. He was noted to have a strong suck (for feeding), however, he had desaturations during feeding attempts, with a recorded apnea. At 3:45 p.m., Jeffrey was noted to have a significant apneic episode (ceased breathing for more than 15 seconds), he became cyanotic, and “very aggressive stimulation was needed,” in addition to mask oxygen. At that time, his oxygen saturation level was low at 58. At approximately 7:00 p.m., Jeffrey was placed on a nasal cannula for oxygen (vapotherm 2 LPM 23%). Jeffrey had several additional apneic episodes during his first day of life. On three occasions, the apnea lasted for more than 15 seconds, he became cyanotic, and required gentle or vigorous stimulation. Due to these incidents, on February 24, 2014, an echoencephalograph (EEG) was performed. The EEG finding and impression were as follows: FINDING: Transcranial head ultrasound was performed with gray scale imaging via anterior fontanelle. This demonstrates normal brain parenchymal echogenicity. There is a normal germinal matrix and cord plexus. There is no hydrocephalus or intraparenchymal hemorrhage. Impression: Normal transcranial head ultrasound as above. Jeffrey remained at the Bayfront NICU until March 5, 2014. During his NICU stay, he had a cranial ultrasound which was interpreted as normal; he was noted as having frequent arching and possible posturing; and continued to have poor feeding coordination. On March 5, 2014, he was transferred to All Children’s Hospital to obtain a brain MRI, neurology consultation, and a speech therapy consultation. On March 6, 2014, the brain MRI was conducted. The MRI was interpreted as showing a brain with normal signal intensity, including gray and white matter on multiple sequences. Ultimately, Jeffrey was discharged from All Children’s Hospital after approximately three days.3/ Following his discharge, Jeffrey exhibited developmental delays. When Jeffrey was approximately nine months old, he was evaluated by Elizabeth Barkoudah, M.D., the attending physician for the Neurodevelopmental Disabilities Department at Children’s Hospital in Boston, Massachusetts. Her report documents his post discharge history as follows: Concerns with Jeffrey were first noted in the neonatal period given low tone. This has prompted him to be seen by various specialties in Florida including Neurology, Neurosurgery, Physiatry, Genetics, Ophthalmology and Neuro-opthalmology. He has had a head ultrasound at 5 months of age which showed increased frontal lobe fluid. A brain MRI was repeated at 7 months of age including a cervical MRI. Again this showed the increased fluid. He was seen by Neurosurgery who did not feel that shunting was needed. His cervical MRI showed some narrowing with persistent SCF flow around the spinal cord. This MRI was obtained after papillodema was found on his examination. This examination was recommended due to “choppy visual tracking.” Over time it was felt that this was not truly papilledema and is simply elevated optic nerves. Visual assessment at the time showed weaknesses left more than right. In regards to evaluations, he has also been seen by Genetics who has obtained a chromosomal microarray which was unremarkable. He had thyroid testing and CPK levels which were normal. He has been seen by Physiatry who recommended ongoing therapy. They have provided him with a Benik trunk brace which now he only uses with exercises. He has been receiving Early Interventions services including PT two times per week, OT one time per week and speech therapy one time per week. Dr. Barkoudah’s impression was that Jeffrey’s low muscle tone was “likely central in origin and related to his gross motor delays.” She did not recommend any further assessments. Dr. Barkoudah opined in her report that the average age for diagnosis of cerebral palsy is two years of age, and, therefore, Jeffrey did not currently meet the diagnostic requirement. At approximately 13 months of age, Jeffrey was referred to Radhakrishna K. Rao, M.D., D.C.H., M.S., at Bay Regional & International Institute of Neurology, for a neurological evaluation. After conducting an examination of Jeffrey, Dr. Rao’s report documented his clinical impression as follows: Patient has a complex medico-neurological condition of severe complexity. Patient had difficult neonatal period as described above. Developmentally child is making progress at a slower pace without any regression. In my opinion, the loose umbilical cord wrapped around his legs and abdomen may have contributed to initially for persistent transverse lie and later descent for normal vaginal birth. This also might have contributed for respiratory depression and low Apgar score resulting in intermittent hypoxia. This appears to be the reason for his development of generalized hypotonia, gross motor and fine motor developmental delay and hypotonic cerebral palsy. Dr. Rao recommended an additional EEG to document any underlying neuronal dysfunction and seizure activity. An EEG was conducted several days later and was interpreted as within normal limits for Jeffrey’s age, and there was no definite seizure activity seen. Jeffrey presented to Dr. Rao again on April 21, 2015. On this occasion, among other medical concerns, Dr. Rao diagnosed Jeffrey with hypotonic cerebral palsy. Jeffrey continued to treat with Dr. Rao through August 2015. On June 21, 2017, Jeffrey (at age three years, four months) presented to the neurology clinic at All Children’s Hospital for follow-up of his history of hypotonia and global development delay. According to the clinical note, he had been diagnosed previously with congenital hypotonia, and had developmental delays including expressive speech delays. It was further documented that Jeffrey has a history of abnormal signal intensities on brain MRI. The clinical note described Jeffrey’s developmental delays as follows: Parents relate today that he is making steady for developmental progress, although slowly. Parents are very involved with a home regimen of multiple therapies which they engage in with him on a daily basis. Presently, he is able to walk independently. He continues to be unsteady and falls frequently. He is not able to stoop to pick up an object and then stand back up alone without holding onto something. He is not yet running. He can pick up a Cheerio or small object with a pincer grasp: not able to yet hold onto a crayon and scribble. Expressive language reveals approximately 15-20 independent words, although these are inconsistent. He knows (approximately) 8 signs and uses these appropriately. He is not able to identify pictures in books; does not know body parts. He waves “bye bye” and initiates some activities. He is not potty trained. He wears glasses and does vision therapy. Developmental level at this time by Denver Developmental Assessment is gross motor: (approximately) 15 mo.; fine motor/adaptive: (approximately) 10 mo.; language: (approximately) 15 mo.; personal/social: (approximately) 15 mo. The All Children’s clinical note again documented Jeffrey as having congenital hypotonia and concluded that he is globally delayed, but making slow gains with “a lot of intervention/therapy.” As indicated in the preceding paragraphs, Petitioners have commendably sought advice, treatment, and evaluations from multiple health care providers and specialists in an effort to care for Jeffrey. At the time of Mrs. D’Angelo’s deposition on September 17, 2018, Jeffrey was four years, seven months old. Mrs. D’Angelo credibly testified about a “day in the life” of Jeffrey, his development, and his limitations. Jeffrey is currently receiving multiple therapies on a daily basis at Petitioners’ home. Mrs. D’Angelo credibly testified that Jeffrey receives physical therapy once per week, occupational therapy twice per week, speech therapy three times per week, music therapy twice per week, and Applied Behavioral Analysis therapy for 40 hours per week. His various therapies essentially begin at 8:00 a.m., and continue throughout the day until 5:00 p.m. Mrs. D’Angelo explained that, in physical therapy, the primary goal at this time is for Jeffrey to be able to transition stairs. Over the last 4.5 years of physical therapy, there has been some slight improvement in that 1) he no longer has to wear a medical helmet; 2) he no longer has a walker; 3) his leg braces were previously from the knee down and now they are only ankle braces; 4) and he can walk independently indoors with adult supervision with mats on the floor to protect him from falls. At this time, he does not walk independently without the mats due to the potential fall risk. Concerning his occupational therapy goals, Mrs. D’Angelo credibly testified that they are working on his prewriting skills. The team is working on his ability to draw a line. At present, he does not have the ability to independently hold a pencil or a crayon correctly. Mrs. D’Angelo explained that he continues to require speech therapy, as he is functioning at a one-year-old level. Although Jeffrey may be able to say 20-25 words, they are approximations. Essentially, he can say “mom,” “dad,” and “hi” clearly. Mrs. D’Angelo further credibly testified concerning other limitations. Jeffrey wears diapers and is not potty- trained. He can follow very limited one-task directions, but rarely two-step directions. Jeffrey cannot and does not play with other children. While he can use a “sippy cup,” he cannot use an open cup to drink and cannot use utensils to feed himself. In April 2018, Jeffrey was diagnosed with an undisputedly rare genetic disorder referred to as CHAMP 1. The undersigned finds that there was insufficient evidence presented by the parties concerning this disorder to make any findings as to whether Jeffrey’s impairments are caused by genetic or congenital abnormality. NICA retained Donald C. Willis, M.D., an obstetrician specializing in maternal-fetal medicine, to review the medical records of Jeffrey and Mrs. D’Angelo, and opine as to whether there was an injury to his brain or spinal cord that occurred in the course of labor, delivery, or resuscitation in the immediate postdelivery period due to oxygen deprivation or mechanical injury. Dr. Willis made the following findings and expressed the following opinions in a report, dated March 27, 2017: I have reviewed [the] medical records for the above individual. The mother, Katis D’Angelo was a 25 year old G1 with a history of successful treatment for preterm labor at 32 weeks. Prenatal course was otherwise without complications. The Mother was admitted at 37 weeks gestational age with spontaneous rupture of the membranes. Her cervix was dilated 1 cm. She was not in labor. Pitocin induction of labor was initiated for rupture of membranes. The fetal heart rate (FHR) monitor tracing was reviewed. There was no fetal distress. Cesarean section was done for failure to progress. Birth weight was 3,575 grams (7 lbs 14 oz’s). Extraction of the fetal head during Cesarean section was described as difficult. Several loops of umbilical cord were around the body of the fetus. Apgar scores were 2/6/8. Positive pressure ventilation was given for 5 minutes and chest compressions for 30 seconds. The baby was taken to the NICU for evaluation and management. NICU evaluation noted overall reduced motor activity and a rapid respiratory rate. X-ray showed bilateral vascular markings, compatible with transient tachypnea vs pneumonia. Several episodes of apnea occurred. Capillary blood gas at 5 hours of age was normal with a pH of 7.36. Antibiotics were started and continued for 7 days. Blood cultures were negative. Initial platelet count was low at 84,000. A short tongue frenulum, Ankyloglossia was present. This birth defect was later surgical[ly] corrected. Orogastric tube feedings were required for poor feeding coordination. Frequent body arching and posturing episodes developed. EEG on DOL 2 was normal. Head ultrasound was also normal. The baby was transferred to All Children’s Hospital due to possible seizure activity and poor feeding. Genetic testing, including microarray studies were negative. The child continue[d] to have hypotonia after hospital discharge. Neurology evaluation for hypotonia and motor developmental delay was done with the impression of a “complex medico-neurological condition of severe complexity.” EEG at about one year of age was normal. Sleep studies suggested upper airway obstruction. MRI found mild cervical spine narrowing, but no brain injury. There was no apparent obstetrical event that resulted in loss of oxygen or mechanical trauma to the baby’s brain or spinal cord that resulted in injury during labor, delivery and the immediate post delivery period. Dr. Willis’s findings and opinions were confirmed and verified in an affidavit dated September 1, 2017. At his deposition, Dr. Willis testified, in pertinent part, as follows: Q. Okay. What is your opinion as to whether or not Jeffrey D’Angelo suffered a birth-related neurological injury? A. I do not believe that there was any apparent obstetrical event that resulted in loss of oxygen or mechanical trauma to the baby’s brain during labor, delivery, or the immediate post-delivery period. * * * Q. Would you briefly summarize your findings and basis for your opinion? A. Yes. Q. And refer to the report if necessary. A. Yeah. The mother was admitted to the hospital at 37 weeks gestational age with spontaneous rupture of the membranes. Labor was induced. She progressed to about 5 centimeters dilation and then had failure to dilate after that point. Cesarean section was then done for failure to dilate. And the – let me back up a moment. I did see the fetal heart rate tracings. And there was a nice set of fetal heart rate tracings during labor. I reviewed those. The fetal heart rate tracing did not show anything to me that suggested fetal distress during labor. It appeared to be a reassuring fetal heart rate pattern. Delivery was done by Cesarean section. Delivery was stated to be complicated or difficult because the umbilical cord was around the baby’s body. And the – and the delivery was stated to be difficult. When the baby was born, it was depressed. Apgar scores were 2 at 1 minute, 6 at 5 minutes, and 8 at 10 minutes. The baby did require positive-pressure ventilation for approximately 5 minutes. And chest compressions were approximately 30 seconds. The baby was taken to the neonatal intensive care unit. Chest x-ray showed – had some bilateral vascular markings which were compatible with transient tachypnea of the newborn. Shortly after birth the baby had some episodes of apnea. A capillary blood gas was done about 5 hours after birth, and it was normal. The pH was 7.36. EEG was done on day of life two, which was normal. Head ultrasound was also normal. The baby was transferred to All Children’s Hospital because – from what I gather from the records because they wanted to do an MRI. The MRI was done about two weeks after birth and was – and was normal. With respect to Jeffrey’s Apgar scores, Dr. Willis testified, in relevant part, as follows: Q. What did those Apgar scores mean or indicate to you in the context of your review of this case? A. Right. Well, usually we say that the one Apgar – the 1-minute Apgar score tells you what resuscitation is required. So Apgar score of 2 would be a low Apgar score. And that would mean that some resuscitation would be required after birth. The 5-minute Apgar score tells you a little bit more about what the baby’s acid base status, oxygen deprivation status would be. And that was 6. We consider the Apgar to be low if it is below 7. So the 5-minute Apgar was slightly lower than expected. By 10 minutes it was 8. So that would be within normal limits’ score for an Apgar. With respect to the diagnostic studies performed during the newborn period, Dr. Willis testified, in relevant part, as follows: Q. What is the purpose of an EEG? A. Purpose of the EEG is to determine if there’s any electrical brain injury. Q. Okay, and that’s a diagnostic study to determine if the brain is functioning properly? A. Correct. Q. And in this case on the second day of life an EEG was done and it was read as normal? A. Correct. Q. If J.D. in this case had suffered oxygen deprivation significant enough to cause brain damage in the course of labor and delivery, would you expect an EEG on day of life two to be normal? A. No. You would expect some abnormalities in that EEG. Q. So this EEG, correct me if I am wrong, would be inconsistent with . . . J.D. having suffered oxygen deprivation significant enough to cause brain injury at the time of labor and delivery in this case? A. Correct. * * * Q. And then you mentioned that an MRI was done at approximately 2 weeks of age? A. Correct. Q. And are you referring to the MRI that was dated March 6, 2014? A. Correct. Q. And what did that MRI reflect? A. That MRI was read as normal. So nothing on that MRI that suggested hypoxic or ischemic brain injury. And I felt that was very important in my – in my final disposition of this case because the delivery was somewhat difficult. And the baby was depressed at birth and required resuscitation. So that made me somewhat concerned about oxygen deprivation at birth. However, if the baby has oxygen deprivation at birth enough to cause brain injury, then the EEG will be abnormal and for sure the MRI at two weeks is going to show abnormalities. With a normal MRI at two weeks after birth, it really confirms that there was no oxygen deprivation during labor or delivery or the immediate post delivery period that was substantial enough to cause identifiable brain injury. Q. Okay. Is it fair to say, just to follow up on that MRI at two weeks, that the findings on that MRI are inconsistent with J.D. in this case having suffered oxygen deprivation significant enough to cause brain injury at the time of labor and delivery? Q. Correct. Dr. Willis’s findings and opinion that there was not a brain injury caused by oxygen deprivation or mechanical injury in the course of labor, delivery, or resuscitation in the immediate postdelivery period in a hospital are credited. NICA also retained Laufey Y. Sigurdardottir, M.D., a pediatric neurologist, to review Jeffrey’s medical records, conduct an independent medical examination (IME), and opine as to whether he suffers from a permanent and substantial mental and physical impairment as a result of a birth-related neurological injury. Dr. Sigurdardottir reviewed Jeffrey’s medical records and performed an IME on March 29, 2017. Dr. Sigurdardottir made the following findings and summarized her evaluation as follows: Pregnancy and Birth Summary: Jeffrey was born at 37 weeks 3 days to a 25-year-old G1, P0 serology negative mother after normal, noncomplicated, pregnancy. She did have premature labor at 32 weeks that resolved and then spontaneous rupture of membranes at 11 p.m. on 02/22/2014. Jeffrey’s mother presented shortly before midnight to Bayfront Health Labor and Delivery Ward, was found to have 1 cm cervical dilation and was admitted. She was not felt to be in active labor at that time. Labor was augmented with Pitocin but an emergent C-section was performed at 1 p.m. on 02/23/2014 due to failure to progress and arrested of fetal head. Fetal heart rate strips are available for our review and no fetal heart decelerations are noted. During the Cesarean section, the infant was found to be in a ROT position and large for gestational age. The extraction was difficult. The umbilical cord was noted to be wrapped around the legs with several loops and also around the abdomen. The infant was depressed at birth with Apgars of 2, 6 and 8 at 1,5 and 10 minutes. The infant was delivered at 1352 on 02/23/2014 weighing 3570g, length 51 cm and head circumference of 33cm. The infant did receive chest compressions for 30 seconds and positive pressure ventilation. Infant was noted to have respiratory distress and was admitted to Bayfront NICU for further evaluation. Infant had initial exam on admission suggestive of perinatal depression. His neurologic examination on admission revealed decreased muscle tone, decreased motor activity, symmetric Moro reflex, response to stimuli and no tremor. The infant had recovery of neurologic status apart from continued hypotonia and difficulty feeding. Infant was worked up with labs including a capillary blood gas at 5 hours of life showing a pH of 7.36 and a base excess of - 0.6. PCo2 was 48. Initial creatinine measurement was 1 and had a steady decline after that. AST and ALT were found to be normal. Initial platelets were found to be 84,000 with recovery to 165,000 by 6 a.m. on 02/24/201[4]. EEG performed on day of life 2 was found to be normal with no indication of a lowered seizure threshold and no abnormality on background activity. Head ultrasound was also performed and found to be normal. Infant had transient tachypnea, tongue ankyloglossia, possible sepsis and was treated with antibiotics. Nutritional status was found to include initial low blood glucose and episodes of arching with feeding. The patient did require partial gavage feeding prior to discharge. Discharge was on 03/05/201[4]. Developmental and Medical History: Jeffrey continued to exhibit delays in neurologic development. Per parents’ report, he had poor feeding abilities, was found to have low muscle tone and required therapies, occupational, physical, and speech therapy, from a very early age. He sat around 14 months, crawled at 15 months and walked unassisted at 22 months. He has had significant language delays, although at this time he has 20-25 words. He has been found to have apraxia of speech. The patient has had ophthalmologic abnormality including a downward eye deviation that the parents report and was seen at Boston Children’s Hospital at the age of 9 months for a second opinion of the underlying etiology for his delays. He has had genetic workup including microarray and Prader-Willi has also been ruled out. Patient has had multiple neuro radiologic evaluations of brain and spinal cord. The initial MRI was performed on 03/06/2014 and found to have a brain that seems normal in signal intensity including gray and white matter on multiple sequences. Vascular structures appear grossly normal. The second evaluation is a brain ultrasound on 07/29/2014 which shows mild increased CSF fluid spaces. A second MRI was performed in September 2014 and showed increased bifrontal temporal extraaxial convexity, effusion and mild ventricular dilation as compared to study from 03/06/2014. This was considered to be suggestive of a communicating hydrocephaly with impaired drainage at the level of the arachnoid granulations. An MRI of the cervical spine was also performed and showed mild C3-C5 spinal canal stenosis. A follow up MRI was then performed on 01/26/2015 with no interval change in the spinal stenosis at C3-C5 and no significant change in appearance of the extraaxial fluid or ventricular size. A 3rd follow up MRI then performed in May 2015 which showed possible increased in kyphosis of cervical region but no clear change in ventricular size and possible decrease in amount of extraaxial CSF spaces. Final MRI was then performed on July 2016 which continues to show mild bilateral and lateral ventricular dilation and bifrontal temporal convexity, extraaxial fluid. This was deemed to be stable. In the final MRI there are noted small foci of bifrontal white matter increased FLAIR signal without associated mass effect. Jeffrey has been treated with vigorous therapy, both with therapy providers as well as with his parents and has undergone hyperbaric oxygen therapy. Parents feel that he continues to be significantly delayed as compared to his peers. But now he is more responsive to them. He has been evaluated for possible autism and found to be negative for such symptoms on 3 occasions, as per parents’ report. * * * Physical Examination: Jeffrey is 17.7 kg, 91.4 cm and his head circumference is 51 cm. This places his growth parameters to be at the 95th percentile for weight, at the 13th percentile for length and his head circumference to be at the 59th percentile. His general exam is as follows: Head and Neck: There are no obvious dysmorphic features, although mouth tends to be open. He does have conjugate eye movement. Lungs: Clear to auscultation. Cardiovascular exam reveals first and second heart tones, no noted heart murmurs, no rhythm abnormalities. Abdomen is soft, no hepatosplenomegaly. GU normal. Musculoskeletal: He does have some increased joint laxity. Skin is without abnormal markings. Neurologic Examination: Mental status: The patient is interactive with his parents often needing multiple requests to comply with their requests for him. He does wave bye-bye. He does clap and does have occasional words that are difficult for this examiner to understand. His eye contact seems at times to be poor. No repetitive behavior is noted. Cranial nerves: His pupils are equal, reactive to light. He has full visual fields. Extraocular movements are conjugate. His facial expression is somewhat diminished. His hearing seems intact to voice. Motor exam reveals generalized hypotonia with some increased joint laxity, but full strength. Reflexes are difficult to elicit but present. Balance and coordination is delayed for age, although fine motor skills assessment is not performed. Summary: Jeffrey is a 3-year 1-month-old boy with motor and speech delays from birth. There is documented fetal depression but no clear documented fetal heart rate disturbance after the onset of active labor. His current status is improved from early in life and he is now able to ambulate without support and has started speaking in single words. There are no signs of autistic features. Result as to question 1: Jeffrey is not found to have a substantial physical impairment at this time. He is found to have a substantial language impairment at this time. Result as to question 2: In review of available documents, although having neurologic depression requiring some resuscitation at birth, there is no clear acute hypoxic event, and fetal heart rate strips were relatively benign. MRI performed in the neonatal period, EEG performed in the neonatal period did not support an acute encephalopathy. No laboratory evidence of multisystem hypoxic changes were noted in postnatal period. Result as to question 3: The prognosis for full motor and mental recovery is guarded but his life expectancy is full. Due to absence of evidence of hypoxic event during active labor, absence of secondary findings supportive of a hypoxic encephalopathy (MRI, laboratory or EEG) and his ongoing motor and cognitive progress, I do not feel that he should be included in the NICA program. (JE I, P. 1-3). Dr. Sigurdardottir confirmed and verified her opinions in an affidavit dated August 31, 2017. Dr. Sigurdardottir also testified, in relevant part, during her deposition on February 14, 2018, as follows: Q. And what were your conclusions to those questions (asked by NICA)? A. The conclusions are the following: Jeffrey is not found to have a substantial physical impairment at this time. He is found to have a substantial language impairment at this time. That is question one. So question one, he does not fulfill the criteria having both a substantial physical impairment and mental impairment. Result of the question two, that although having neurologic depression requiring some resuscitation at birth there is no clear precipitating acute hypoxic event that we can establish with the available records that we have, including fetal heart restrict, as well as in the neonatal post natal period there was no evidence of multi- system organ failure that often goes along with hypoxic ischemic events. So there was an MRI performed within the first two weeks, an EEG that was performed in a neonatal period, and then no laboratory evidence of multisystem hypoxic injury. On cross examination by Mr. D’Angelo, Dr. Sigurdardottir further explained her opinions and analysis as follows: Q. So what do you personally think was just the resuscitation he needed at birth likely? And I understand we’re not dealing in terms of absolutes, but was the likely cause of my son’s injury due to low amounts of oxygen at birth? A. Well, I would say it’s clear he had neurologic depression at birth. Then, we start looking for signs that would indicate that that would happen, such as the fetal heart rate [t]racing, that was benign. There was nothing in that that indicated there was lack of oxygen. And then after birth, even though he had neurologic depression, we did not have any of the hard evidence that he had significant hypoxic ischemic encephalopathy, is what we call it, and that’s when you have other systems involved, like the liver test becomes abnormal, the creatine continues to rise, his active base balance at the age of five hours looked fairly good, did not show a metabolic acidosis. And then an MRI that was performed, I believe, on day of life 10 or 11, that did not show any abnormality at that point that indicated an acute ischemic injury. So we have little that supports it from all of the laboratory results that we have and the fetal heart rate [tracing]. Dr. Sigurdardottir’s findings and opinion that Jeffrey has a substantial language impairment is undisputed and credited. Her opinion that Jeffrey does not have a substantial physical impairment is not credited for the reasons discussed below in the Conclusions of Law. Dr. Sigurdardottir’s opinion that there is evidence of fetal depression, but insignificant evidence (at birth) to establish significant hypoxic ischemic encephalopathy is supported by the evidence and is credited. Petitioners submitted a notarized statement from Jeffrey Huber in support of their position that Jeffrey sustained a birth-related neurological injury. It appears that Mr. Huber was the respiratory therapist in the operating room at the time of delivery. Mr. Huber’s statement provides, inter alia, that Jeffrey had a “lack of ventilation for longer than 2 minutes.” Although Mr. Huber’s statement has been considered, it constitutes hearsay and cannot support independently any finding of fact. Additionally, Dr. Willis and Dr. Sigurdardottir, the only qualified medical experts who have testified in this matter, both represented that Mr. Huber’s statement was duly considered by them and did not change any of their opinions and ultimate conclusions. Specifically, Dr. Willis testified, in relevant part, as follows: Q. Did that report [and] statement from Mr. [H]uber have any impact on your ultimate opinions and conclusions? A. No. No, it did not. Most of the things that he – that he talked about in there were part of the medical records. The fact that the baby required resuscitation, required chest compressions was all in the medical records. So nothing new there. He does not state exactly what his position is, but I assume from what I’ve read he must be somehow involved with respiratory therapy. So nothing new as far as what was in the medical records in his report.
The Issue The issue presented is whether Respondent is guilty of the allegations set forth in the Administrative Complaint, and, if so, what disciplinary action should be taken against him, if any.
Findings Of Fact At all times material hereto, Respondent has been a physician licensed to practice in the State of Florida, having been issued license number ME 0020248. Respondent is a board- certified pathologist who completed a residency in obstetrics and gynecology in Venezuela and practiced in the field of obstetrics and gynecology in South America for almost five years before coming to the United States. On April 20, 1991, patient J. B., a 27-year-old female, came to A Woman's Care, where Respondent was then employed, for the purpose of terminating her pregnancy. She indicated on a patient history form that the date of her last menstrual period was January 30, 199l. According to the medical records from A Woman's Care, she did not express any uncertainty or equivocation with respect to that date. One method of determining gestational age is based on calculating from the last menstrual period, assuming that the patient's history is reasonably reliable. With a history of a last menstrual period on January 30, 1991, the gestational age of the fetus on April 20, 1991, based upon a calculation by dates, was seven weeks. After obtaining a history from the patient with respect to the date of the last menstrual period, the physician needs to perform a bi-manual examination of the patient in order to assess the size of the uterus and to confirm the history given by the patient. Although the bi-manual examination is a reasonably reliable method of assessing the stage of pregnancy, it is a subjective examination and can sometimes be difficult. There is an acknowledged inaccuracy with respect to that clinical evaluation. The most accurate method of determining the gestational age of a fetus is through ultrasound examination. An ultrasound is performed when there is uncertainty as to the gestational age, such as when the patient does not know the date of her last menstrual period or when there is inconsistency between the patient's disclosed date and the physician's bi-manual examination. There is a general correlation between the size of the uterus in centimeters on bi-manual examination and gestational age in weeks. It is important to determine the gestational age of the fetus before performing a termination of pregnancy because the gestational age is the determining factor in deciding the size of the instruments to be used in the procedure and the amount of tissue to be removed. Respondent performed a bi-manual examination of the patient and recorded that his examination revealed a uterus consistent with an approximately seven-week gestation. Because the gestational age by dates and the results of the bi-manual examination both indicated a seven-week pregnancy and were consistent, Respondent did not order an ultrasound examination for the purpose of determining gestational age. On April 20, 1991, Respondent performed a termination of pregnancy on patient J. B. after the patient was informed of the possible risks of the procedure and after the patient signed a Patient Informed Consent Form. That Form detailed the possible risks, including infection and incomplete termination. Based upon the patient's history and the bi-manual examination and his conclusion that the patient was approximately seven-weeks pregnant, Respondent used an 8 mm Vacurette to terminate patient J. B.'s pregnancy. An 8 mm Vacurette is an appropriately-sized device to terminate a seven-week pregnancy. After completing the procedure, Respondent submitted the tissue obtained to a pathologist who determined that three grams of tissue had been submitted, consisting of products of conception and chorionic villi. The pathology report revealed what would reasonably be expected as a result of the termination of a seven-week pregnancy. After the procedure, the patient was given written instructions for her care and was discharged from A Woman's Care at 10:35 a.m. On April 21, 1991, at approximately 6:30 a.m., the patient's grandmother telephoned A Woman's Care to advise that the patient was complaining of dizziness and pain. The patient was advised to take Tylenol and call back if she continued to feel sick. At approximately 7:30 a.m., the patient's grandmother called again to advise that the patient was going to go to the hospital. On April 21, 1991, at 1:25 p.m., patient J. B. arrived at the Emergency Room at North Shore Medical Center with a temperature of 104.3 degrees, an elevated white blood cell count, chills, lower abdominal pain, and spotting. The patient was seen during her North Shore admission by Dr. Ramon Hechavarria, a physician certified in obstetrics and gynecology, and by Dr. Tomas Lopez, a general surgeon. Dr. Lopez noted in his consultation report that a pelvic bi-manual examination that he performed on April 21 showed an enlarged uterus corresponding to approximately 11-12 weeks' gestation. An ultrasound examination done on April 21 revealed a uterus measuring 11.0 x 7.8 x 7.8 centimeters and a viable intra- uterine pregnancy which was estimated by the radiologist to be 13-14 weeks' gestational age. On April 22, the patient underwent termination of her pregnancy by Dr. Hechavarria who noted in his operative report that both the pelvic ultrasound and a bi-manual examination revealed an intra-uterine pregnancy of about 11 weeks with a live fetus. An ultrasound performed intra-operatively confirmed that all fetal tissue had been removed and that there were no perforations. Infection and an incomplete termination are two of the recognized complications resulting from terminations of pregnancy. The fact that a patient suffers an infection or an incomplete termination does not, per se, indicate any negligence on the part of the physician. Respondent did not fall below the recognized standard of care by failing to perform an ultrasound on patient J. B. His examination revealed a gestational age consistent with the date identified by the patient as the date of her last menstrual period. Accordingly, there was no need to perform an ultrasound. Respondent did not fall below the recognized standard of care by misjudging the gestational age of the fetus. It is not uncommon for a physician to misjudge the length of gestation by several weeks. For example, Drs. Lopez and Hechavarria concluded the fetus had a gestational age of 11 weeks; yet, the ultrasound reported 13-14 weeks. Respondent did not fall below the recognized standard of care by using the wrong size of equipment to perform the termination of pregnancy. He used the proper equipment consistent with his judgment as to the length of gestation.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED THAT a Final Order be entered finding Respondent not guilty of the allegations and dismissing the Administrative Complaint filed against him in this cause. DONE AND ENTERED this 25th day of July, 1997, at Tallahassee, Leon County, Florida. LINDA M. RIGOT Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 25th day of July, 1997. COPIES FURNISHED: Hugh R. Brown, Esquire Agency for Health Care Administration Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792 Jonathon P. Lynn, Esquire Stephens, Lynn, Klein & McNicholas, P.A. Two Datran Center, Penthouse II 9130 South Dadeland Boulevard Miami, Florida 33156 Dr. Marm Harris, Executive Director Board of Medicine Agency for Health Care Administration Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0770 Jerome W. Hoffman, General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32309
Findings Of Fact Stipulated facts 2/ The Respondent is a licensed physician in the State of Florida and has been licensed in Florida at all times material herein. The Respondent is Board Certified in family practice. The patient B. M., a female born on May 18, 1934, with a history of hypertension, diabetes, and obesity, presented to the Respondent on multiple occasions between August of 1979 and November of 1990. On September 29, 1979, when she was forty-five years old, patient B. M. notified the Respondent that her periods were spreading out and that she was getting hot flashes. On February 18, 1982, patient B. M. indicated that she was having irregular periods every couple of months. The Respondent's medical records indicate that he did not see or treat the patient B. M. between October 1, 1984, and July 3, 1987. On July 3, 1987, patient B. M. presented to the Respondent with complaints of excessive vaginal bleeding for the past three (3) months. The patient indicated the bleeding had stopped approximately three weeks earlier. The Respondent diagnosed patient B. M. with vaginitis, and prescribed her medication for vaginitis, based on the patient's complaints of vaginal discharge. Respondent did not perform a pelvic examination on that day to make that diagnosis. Patient B. M. returned the following week for a pelvic examination. The Respondent did not document the medical history of the patient B. M. during the preceding three years, although she had a history of high blood pressure and diabetes, both conditions that require periodic monitoring and prescription medication. The Respondent also did not document any pertinent information relating to the patient's gynecological history, including, but not limited to, the dates of the patient's last period, how often her periods were occurring, and how much she was bleeding, despite her complaints of excessive bleeding. On August 7, 1987, after several other visits, the patient B. M. returned for an examination. A pelvic examination revealed a vaginal laceration that was bleeding. On January 18, 1988, patient B. M. presented to the Respondent with complaints of irregular bleeding for the prior month. The Respondent suggested a dilation and curettage (scraping of the uterine walls) if patient B. M.'s bleeding continued. On December 21, 1989, patient B. M. presented to the Respondent with complaints of excessive vaginal bleeding with clots since the previous night. The Respondent indicated that the patient had her regular period the previous week, and was using condoms. The Respondent performed a pelvic examination which revealed blood clots, and diagnosed patient B. M. with dysfunctional uterine bleeding and administered progesterone to patient B. M. The Respondent did not document any additional information concerning the patient's menstrual activity, such as how often she had periods, what was meant by uncontrollable vaginal bleeding, where the bleeding was coming from, or why she was using condoms. The patient B. M. continued to complain of occasional bleeding after December 21, 1989, and on January 15, 1990, the Respondent referred the patient B. M. to a gynecologist. On February 5, 1990, the patient B. M. presented to a gynecologist, who took cervical biopsies and subsequently performed a dilation and curettage on the patient B. M. on or about February 23, 1990. The patient was subsequently initially diagnosed with grade two endometrial cancer, and after biopsy was diagnosed with grade three endometrial cancer and was referred to another gynecologist at the University of Miami. 3/ On April 5, 1990, the patient B. M. underwent a total hysterectomy. The patient B. M. was then diagnosed with Stage III-C endometrial carcinoma and underwent intravenous Adriamycin chemotherapy. On December 25, 1990, the patient B. M. expired. Facts based on evidence at hearing At all times material to this case, the subject patient 4/ weighed approximately three hundred pounds. Periods spreading out and hot flashes are signs that a woman may be beginning menopause. The average length of time between the beginning of menopausal symptoms and a cessation of menstruation is six months to one year. Endometrial cancer is cancer of the uterus. It is the most common gynecological cancer in women. Endometrial cancer occurs most often in women who are post-menopausal. About 20 to 25 percent of women are diagnosed with endometrial cancer before menopause. Most patients are diagnosed with endometrial cancer after the age of 50. When diagnosed early, patients with endometrial cancer have a very high survival rate. When diagnosed late, patients with endometrial cancer have a very low survival rate. The subject patient had several of the risk factors associated with endometrial cancer. The first symptom in most cases of endometrial cancer is abnormal bleeding. Any woman with post-menopausal abnormal bleeding should be checked for endometrial cancer. The subject patient was hospitalized in 1982. During that hospitalization she was evaluated by a gynecologist who determined that there was no evidence of abnormal or irregular gynecological problems at that time. After February 18, 1982, through October 1, 1984, there are no references in the Respondent's medical records to the subject patient's menstrual history, and no indication as to whether the patient had regular or irregular menstrual periods during that period of time. The subject patient was not seen by the Respondent on any occasion between October 1, 1984, and July 3, 1987. 5/ The subject patient returned to the Respondent's office on July 3, 1987. On the occasion of that visit she gave a history to the Respondent's office staff which is recorded in the Respondent's medical records as "excessive bleeding vaginal for 3 mos. Stopped 6/13." The Respondent's records for July 3, 1987, do not contain any additional details regarding the nature of the excessive bleeding. The Respondent's medical records for the July 3, 1987, office visit also indicate that at that time the patient had a vaginal infection with a discharge. This information was obtained from the patient. On that day the Respondent did not examine the patient to confirm the condition described by the patient. The Respondent diagnosed the patient as having vaginitis and prescribed Sultrin cream and Betadine douche for the vaginitis. The medical records for the July 3, 1987, office visit note that the patient had high blood pressure. Although the records, standing alone, do not clearly show that any treatment was undertaken on that day for the patient's high blood pressure, during the course of the July 3, 1987, visit, the Respondent prescribed medication for the patient's high blood pressure, as well as syringes for her diabetes. Those prescriptions were recorded in the patient's chart on the front cover. Because the subject patient had returned for a single office visit on July 3, 1987, after an absence of almost three years, the Respondent determined at that time that he needed to do a full physical examination on her, as well as a pelvic exam. Although the Respondent did not perform either examination at the July 3, 1987, office visit, he made plans to do both shortly thereafter. The subject patient returned ten days later, on July 13, 1987, at which time the Respondent performed a complete physical examination of the patient. No pelvic examination was performed that day, because the Respondent was having her period. The Respondent asked the patient to return one week later for a pelvic examination. The subject patient returned on July 20, 1987, at which time a pelvic examination was performed. On that day there was no evidence of any irregular or unusual bleeding. The patient did have a vaginal infection that day. The vaginal infection was treated appropriately by the Respondent. In view of the vaginal infection, the patient was advised to return to the office one week later, at which time she would be examined again. The subject patient returned to the Respondent's office on August 7, 1987, for a follow-up pelvic examination, at which time the Respondent identified a small superficial laceration in the patient's vagina. The laceration was causing some slight bleeding. The Respondent noted that there was no bleeding from the cervical os, which indicated that the small laceration was the sole source of the patient's bleeding that day. As an additional follow-up, the Respondent ordered a sonogram. The sonogram was ordered in part because, due to the patient's obesity, the Respondent was unable to palpate her internal organs. The Respondent did not document any details concerning the vaginal laceration, such as the size of the laceration, the amount the laceration was bleeding, or the precise location of the laceration, because it was a very small laceration with very slight bleeding which was of very little medical significance. The Respondent did not refer the patient to a gynecologist after learning the results of the sonogram he ordered on August 7, 1987. The Respondent concluded that the 1987 sonogram results were not significantly different from the 1982 sonogram results. Such conclusion was reasonable under the circumstances. Accordingly, the 1987 sonogram results did not suggest any need for further investigation. The subject patient returned to the Respondent's office on August 24, 1987, at which time she had no complaints of any type of vaginal bleeding. She was being seen in order to follow up on her other complaints, notably her diabetes and her high blood pressure. The Respondent assumed that the vaginal laceration had healed and did not conduct a pelvic examination of the patient during that visit. After August 24, 1987, and before January 18, 1988, the Respondent saw and treated the subject patient once a month on four more occasions. The medical records for those four office visits do not mention the patient's menstrual history or whether she was bleeding on any of those occasions. During the four monthly visits between August of 1987 and January of 1988, the subject patient did not complain of any episodes of irregular vaginal bleeding. On January 18, 1988, the subject patient returned to the Respondent's office with complaints of irregular vaginal bleeding since having been the victim of a mugging during the previous month. The Respondent did not record any detailed information about the bleeding, such as her current menstrual condition, how much she was bleeding, or how often she was bleeding. The Respondent concluded that the bleeding was probably due to the patient's anxiety about the recent mugging incident. Nevertheless, he wanted to follow up on the irregular bleeding if it did not resolve on its own. To that end he discussed the matter with the patient and told her that if the irregular bleeding did not get better, she should come back and he would do a D & C. The Respondent noted in his record for that visit: "May need D & C if bleeding continues." In view of the patient's intelligence, the Respondent fully (and reasonably) expected she would tell him if she had any further irregular bleeding. The procedure known as D & C, or dilation and curretage, is a procedure wherein a physician obtains a sample of the lining of the uterus to evaluate it for possible abnormalities. The D & C procedure is commonly used to diagnose, or to rule out, endometrial cancer. Following the office visit on January 18, 1988, the subject patient presented to the Respondent's office on three other visits during each of which she did not have any complaints of irregular bleeding. The subject patient did not have any further gynecological complaints until December 21, 1989. On that day she returned to the Respondent's office with complaints of uncontrollable vaginal bleeding since 7:30 p. m. of the previous evening. During the course of the December 21, 1989, office visit, the subject patient told the Respondent that she had had her last regular menstrual period the week before. She also told him she was using condoms. During the course of the December 21, 1989, office visit the Respondent performed a pelvic examination of the patient and made a provisional or working diagnosis of dysfunctional uterine bleeding. He administered an injection of progesterone and instructed the patient to return in three days. He also instructed the patient to have another pelvic sonogram performed. Dysfunctional uterine bleeding is abnormal uterine bleeding not related to or caused by an organic problem such as cancer, polyps, fibroids, or infections. It is usually caused by an hormonal imbalance. In the case of a woman who is not post- menopausal and who presents with complaints of irregular vaginal bleeding, one of the differential diagnoses can be dysfunctional uterine bleeding. In such a case it is appropriate to administer progesterone prior to embarking on additional studies. In such a case the administration of progesterone is useful for two reasons: (1) if the progesterone is successful in stopping the irregular bleeding its success tends to confirm the differential diagnosis of dysfunctional uterine bleeding, and (2) if the progesterone is unsuccessful in stopping the irregular bleeding it tends to rule out the diagnosis of dysfunctional uterine bleeding and confirm the need for further investigation. Under the circumstances that existed on December 21, 1989, it was reasonable and appropriate for the Respondent to administer progesterone on the basis of a provisional or working diagnosis of dysfunctional uterine bleeding, because if the treatment was successful it would tend to confirm the provisional or working diagnosis and it the treatment was not successful it would rule out the provisional or working diagnosis. 6/ The fact that dysfunctional uterine bleeding was only a provisional or working diagnosis is illustrated by the fact that the Respondent at the same time ordered a sonogram in order to investigate other possible causes of the abnormal bleeding. A verbal report of the results of the sonogram ordered on December 21, 1989, was given to the Respondent's office by telephone on December 26, 1989. 7/ A written report of the results was provided shortly thereafter. The report of the sonogram ordered on December 21, 1989, indicated that the subject patient had an enlarged uterus measuring 18.8 x 9.3 x 10.8 centimeters. The 1989 sonogram report revealed that the patient's uterus was substantially larger than it had been at the time of the 1987 sonogram. The report of the December 21, 1989, sonogram included a recommendation for follow up examination of the uterus and the endometrial canal. The subject patient returned to the Respondent's office on December 26, 1989, at which time she told the Respondent that the bleeding had stopped. He asked her to return again in two weeks. When she returned twenty days later on January 15, 1990, she had started to again have occasional episodes of bleeding and spotting. The Respondent thereupon referred the patient for a gynecological consult. The subject patient was seen by a gynecologist, Dr. William Shure, on February 5, 1990. The patient provided Dr. Shure with a history that her last menstrual period had been on December 19, 1989. This last menstrual period history is the same history that was recorded by the Respondent on December 21, 1989. On February 5, 1990, Dr. Shure took cervical biopsies from the subject patient, and subsequently performed a D & C on the patient on February 23, 1990. The patient was then diagnosed with Stage II-B endometrial cancer. Following a total hysterectomy on April 5, 1990, the patient was diagnosed with Stage III-C endometrial cancer. Stage II-B endometrial cancer is cancer of the uterus with extension into the cervix. Stage III-C endometrial cancer is an advanced stage of cancer of the uterus which extends into the cervix and has metastasis to pelvic lymph nodes. The patient underwent chemotherapy for the cancer. The chemotherapy was unsuccessful and the patient expired on December 25, 1990. At all times material to this case the Respondent used a record- keeping methodology in his medical practice known as the SOAP method. This is an appropriate methodology for record- keeping in a medical practice. The Respondent's records regarding the subject patient demonstrate that he kept a running list of all medications prescribed for the patient. The Respondent's records regarding his care and treatment of the subject patient were sufficient to justify his course of treatment of the patient. 8/ The care, skill, and treatment applied by the Respondent in the treatment of the subject patient from July of 1987 through January of 1990 (the only time period at issue here) was reasonable under the circumstances and did not depart from the level of care, skill, and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. The Respondent's treatment of the subject patient did not constitute gross or repeated malpractice. 9/ The Respondent has not been the subject of any prior disciplinary proceedings.
Recommendation On the basis of all of the foregoing, it is RECOMMENDED that the Board of Medicine enter a Final Order in this case dismissing all charges in all three counts of the Amended Administrative Complaint. DONE AND ENTERED this 17th day of May 1996 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 17th day of May 1996.
The Issue The issues in this case are whether Respondent violated Subsections 456.072(1)(k), 458.331(1)(g), 458.331(1)(m), and 458.331(1)(t), Florida Statutes (2005),1 and Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes (2004), and, if so, what discipline should be imposed.
Findings Of Fact The Department is the state agency in Florida charged with regulating the practice of medicine pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes. At all times material to the Amended Administrative Complaint, Dr. Pendergraft has been a licensed physician in the State of Florida, having been issued license No. ME 59702. Dr. Pendergraft is board-certified in Obstetrics and Gynecology. He does not have hospital privileges in Florida. At all times material to the Amended Administrative Complaint, Dr. Pendergraft, alone or with one or more partners, owned and operated Orlando Women’s Center, Inc. (OWC), a clinic located in Orlando specializing in abortions. OWC is not a hospital. At all times relevant to the Amended Administrative Complaint, Dr. Pendergraft did not have a current, valid Drug Enforcement Administration (DEA) number. On June 3, 2005, R.W. presented to her primary care physician symptoms of weight gain, fatigue, and lack of a menstrual period for several months. R.W. was a marathon runner and had experienced a delay in her menstrual cycle before because of her strenuous training. She had been taking oral contraceptives. At that time, her primary care physician did not diagnose R.W. as being pregnant. A couple of weeks after her visit with her primary care physician, R.W. still had not regained her menstrual cycle and took a home pregnancy test. The results of the home pregnancy test were positive. R.W. contacted her primary care physician, who ordered laboratory tests for R.W. Laboratory tests were conducted on June 14, 2005, and June 21, 2005. Both tests confirmed the pregnancy. R.W. was referred to Bert Fish Medical Center for an ultrasound on June 21, 2005. The ultrasound showed that R.W. was pregnant. The physician who prepared the diagnostic imaging report based on the ultrasound stated in the report: There is a single intrauterine fetus with an estimated gestational age of 24.5 weeks. Positive fetal heartbeat is present at 142 beats per minute. However, there is severe oligohydiamnios with no positive fetal movement. Gestational age is usually calculated from the first day of the last menstrual period (LMP) of the pregnant woman. On average, the last menstrual cycle occurs two weeks prior to conception. Thus, the gestational age that is determined by the LMP is actually two weeks more than the date of conception.2 When the LMP is unknown, fetal measurements are used to calculate the gestational age. Oligohydramnios means a lack of amniotic fluid. Amniotic fluid is basically the fetus’ urine. A lack of amniotic fluid can be caused by the lack of kidneys or obstructed kidneys, rupture of the membranes, or a malfunction of the placenta. The lack of amniotic fluid makes it difficult to assess the fetal measurements using ultrasound. R.W. was referred to an obstetrician, Dr. P.C., who admitted R.W. to Halifax Medical Center for routine laboratory work and an obstetrical ultrasound. The ultrasound was performed on June 22, 2005, and showed that the fetus was in a breech presentation, there was markedly decreased amniotic fluid, the bowel was abnormal, and the ventral wall was suspicious. Based on the ultrasound, it appeared there was gastroschisis or omphalocele. Gastroschisis occurs when the abdominal wall of the fetus does not close properly and the intestines are outside the body. Omphalocele is a herniation of the intestines, and a sac-like structure covers the intestines outside the abdominal wall. The assigned gestational age estimated by the physician reviewing the ultrasound was 25 weeks and five days.3 R.W. was referred to a perinatologist in Jacksonville. Another ultrasound was performed on June 23, 2005. The assigned gestational age was 25 weeks and six days, which would mean that the age of the fetus was 23 weeks and six days from conception.4 The lack of amniotic fluid and the position of the fetus made it difficult to determine the actual gestational age of the fetus. The perinatologist reported the following to Dr. P.C.: At this time, an ultrasound examination was performed which showed a single living fetus in breech presentation. There is no amniotic fluid which precluded an adequate examination of fetal anatomy. The right kidney and bladder were visualized essentially excluding diagnosis of renal agenesis. A normal appearing 4 chamber structure was seen which visually appears to occupy more than 50% of the chest cavity. This is also very difficult to evaluate due to the position of the baby. There appears to be an anterior abdominal wall defect most likely a gastroschisis, however, again this is impossible to evaluate in great detail. Of importance and further complicating the problems in this case, is the biometry. Measurements of head circumference and cerebellum are consistent with 30 weeks, however, the femur length is consistent with 25 weeks. The fact that this patient has been amenorrheic since October when she could be up to 34 weeks gestation is significant. We don’t know the exact gestation but it is of concern that there is a dramatic difference between the extremities, abdomen, and head circumference as well as the cerebellum. This points to a growth retardation process. Doppler studies of the umbilical circulation were slightly elevated but if there had been placental disfunction I would have expected an absent diastolic component which was not the case. * * * [M]y biggest concern has to do with the anhydramnios and the fact that we don’t know for how long this process has been active. Pulmonary hypoplasia is a strong consideration given the size of the chest and the virtual absence of fluid. Nevertheless, not knowing for how long she has not had fluid is difficult to quote her a risk. The second area of concern is that of the appearance of a structural abnormality. Typically gastroschisis is not associated with a chromosomal anomaly, however, given the discrepancies in biometries and the absence of amniotic fluid, I wonder if this is not a gastroschisis or if it is, part of a more complex situation. The perinatologist conveyed his findings to Dr. P.C., who discussed the situation with R.W. R.W. decided to terminate the pregnancy. The office notes of Dr. P.C. stated, “It was felt by me and my partners that facilitating delivery of this non-viable child was appropriate.” Dr. P.C. called Dr. Pendergraft to discuss the case. Dr. Pendergraft agreed to help, and Dr. P.C. gathered R.W.’s medical records to send to Dr. Pendergraft. On July 7, 2005, R.W. presented to Dr. Pendergraft at OWC. R.W. filled out an information sheet and listed the first day of her last normal period as January 5, 2005.5 R.W. filled out the appropriate consent forms, which a counselor reviewed with her. R.W.’s vital signs were taken and laboratory tests were performed by staff at OWC. Dr. Pendergraft’s notes stated that the sonogram showed severe growth restriction of the fetus. He further indicated that there was a possibility of severe pulmonary hypoplasia and risk of life-threatening sudden health issues or probable fetal, prenatal demise. Dr. Pendergraft wrote in his notes that R.W.’s PMD OB/GYN physician concurred with the maternal health reasons for the termination of the pregnancy. On July 7, 2005,6 at approximately 4:27 p.m., Dr. Pendergraft administered Digoxin into the heart of the fetus to stop the fetal heart beat. Dr. Pendergraft and his medical assistant, S.M., monitored the fetal heart beat using a sonogram until the fetal heart stopped. The procedure was documented on a form used by the OWC entitled “Second Trimester Medical Procedure.” On the form, it is noted that the patient was evaluated on July 7, 2005, and found to be 27 to 28 weeks pregnant, which is 25 to 26 weeks from conception. According to T.S., a medical assistant employed by Dr. Pendergraft, the handwriting which indicates the estimated length of the pregnancy belongs to Dr. Perper, a colleague of Dr. Pendergraft. Both Dr. Perper and Dr. Pendergraft signed the form. After the Digoxin procedure was completed, R.W. was taken to a private room and given Cytotec to induce labor. S.M. continued to administer Cytotec and monitor R.W. until 8:30 p.m., when T.S. relieved S.M. At approximately 12:30 a.m., on July 8, 2005, R.W. developed a fever and the administration of Cytotec was discontinued. T.S. administered Ibuprofen to R.W. to lower the fever. At 1:30 a.m., T.S. noted that R.W. was having some cramping. T.S. wrote the following in the progress notes: “I have a standing order from Dr. Pendergraft for 2 cc Demerol [with] 1 cc Phenergran.” This order was to alleviate the pain from the cramping. At the final hearing, T.S. stated that the note was not totally accurate, because the standing order was from Dr. Perper and not Dr. Pendergraft because Dr. Pendergraft did not have DEA authorization. She attributes the error in her notes to her 20-year working relationship with Dr. Pendergraft and her automatically thinking of Dr. Pendergraft in terms of standing orders. The standing order itself was not submitted into evidence. The evidence is not clear and convincing that Dr. Pendergraft gave the standing order for the Demerol and Phenergran. At 4:30 a.m., the cramping had increased. T.S. gave R.W. an injection of 2 cc of Demerol with 1 cc of Phenergran. At 6:30 a.m., R.W. delivered the fetus and placenta at the same time inside an empty water sack. The products of conception, which included the fetus, membranes, and placenta weighed 800 grams. The weight of the products of conception was recorded on a form used by the OWC, entitled “Clinic Examination of Products of Conception.” The form listed the preoperative estimate of gestational age to be 28 weeks, which would be 26 weeks from conception. Dr. Pendergraft was one of the signatories on the form. Dr. Pendergraft charged R.W. $12,000 for the procedure. Although, both Dr. Pendergraft and his associate Dr. Perper, felt that, preoperatively, the gestational age of the fetus was between 27 and 28 weeks, Dr. Pendergraft did not transfer R.W. to a hospital. Jorge Gomez, M.D., testified as an expert witness on behalf of the Department. Dr. Gomez is board-certified in obstetrics and gynecology and in maternal-fetal medicine. Dr. Gomez opined that on July 7, 2005, the age of the fetus from conception was 27 weeks. His opinion was based on biparietal diameter (BPD), the head circumference, the size of the cerebellum, and the femur length. He discounted the abdominal circumference because the abdominal wall defect would result in a less reliable measurement of the age of the fetus. The abdominal wall defect would cause the measurement to be smaller than would be expected for the age of the fetus. Jay Neil Plotkin, M.D., testified as an expert witness for Dr. Pendergraft. Dr. Plotkin has been a licensed physician for 37 years and is board-certified in obstetrics and gynecology. Dr. Plotkin has not treated patients for four years and has not performed an abortion in six or seven years. It was Dr. Plotkin’s opinion that the abortion occurred during the second trimester rather than the third trimester. His opinion is based on the combined fetal and placental weight at time of delivery. He concluded that the gestational age at the time of delivery was 24 weeks, which would translate to 22 weeks of pregnancy from conception. He used a chart to determine the age based on the weight of the fetus, but he did not know if the chart was based on normal fetuses or included fetuses with abnormalities such as the one at issue. Dr. Pendergraft also called Steven Warsof, M.D., as an expert witness. Dr. Warsof is an obstetrician/gynecologist with a subspecialty in maternal-fetal medicine. He has spent most of his professional career pursuing academic issues in obstetrical ultrasonography. It was his opinion that R.W.’s pregnancy was in the second trimester. He also based his opinion on the weight of the products of conception after delivery. Based on the evidence presented, it is clear and convincing that R.W. was in her third trimester of pregnancy when she had the abortion. The only two doctors who placed the pregnancy in the second trimester based their opinions on the weight of the fetus and placenta at the time of delivery. Because of the complications of R.W.’s pregnancy, it is clear that the fetus had not developed normally and was underweight for its age. There had been a lack of amniotic fluid which is essential to development of the fetus. Based on his office records, it is also clear and convincing that Dr. Pendergraft was under the impression that R.W. was in her third trimester of pregnancy when he performed the abortion. The medical records of Dr. Pendergraft do not contain a written certification from two physicians that within a reasonable degree of medical probability the termination of R.W.’s pregnancy was necessary to save the life or preserve the health of R.W. The evidence established that Dr. Pendergraft wrote in his notes that there was a risk of life-threatening, sudden health issues. Assuming he was referring to the health issues of the pregnant woman, this note could be considered a certification that to a degree of medical probability that the abortion was necessary to preserve the health of R.W. However, there is no written certification from another physician that that was the case, and the note of Dr. Pendergraft that R.W.'s primary care physician concurred with the maternal health reasons for termination of the pregnancy is not a written certification from another physician. The medical records kept by Dr. Pendergraft do not contain a written certification that there is a medical necessity for emergency medical procedures to terminate the pregnancy and that no other physician is available for consultation. No evidence was presented concerning the allegations in Counts IV, V, and VI of the Amended Administrative Complaint.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding Dr. Pendergraft guilty of violations of Subsection 456.072(1)(k), 458.331(1)(g), 458.331(1)(m), and 458.331(1)(t)1., Florida Statutes; dismissing Counts IV, V, and VI of the Amended Administrative Complaint; suspending his license for one year followed by three years of probation with indirect monitoring; imposing an administrative fine of $10,000.00; and denying his motion for attorney's fees pursuant to Subsection 120.595(1)(b), Florida Statutes. DONE AND ENTERED this 26th day of October, 2007, 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 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 26th day of October, 2007.
Findings Of Fact Introduction At all times relevant hereto, respondent, Albert Sneij, was a licensed physician having been issued license number ME0034499 by petitioner, Department of professional Regulation, Board of Medicine (Department or Board). Most recently, respondent maintained a practice of family medicine at 460 Washington Avenue, Miami Beach, Florida. Respondent, who is 42 years old, is a native of Syria where he received his medical degree from a Syrian university in 1971. His medical training consisted of a seven year curriculum taken immediately after high school. After graduation from medical school, Dr. Sneij worked a short time in Syria and Lebanon and then immigrated to the United States in June 1972. He worked first as an intern at a hospital in St. Louis, Missouri. After performing a residency in surgery at an Albany, New York hospital and working for a time in an emergency room, Dr. Sneij secured his Florida license in 1979. In 1980, he permanently relocated to the Miami area where he began a family practice. Besides having a Florida license, respondent also holds licenses to practice in New York and California. He has hospital privileges at South Shore Hospital in Miami Beach, but that institution has no obstetrical wing. This case centers around the actions of respondent while delivering the baby of Marlene Alonso in November 1987 and whether such actions conformed to the level of skill, care and treatment expected of a physician in the Miami area. The delivery, which took place after a lengthy period of labor, occurred in a tub of hot water. This procedure is known as underwater birthing. After the baby died, Alonso filed a complaint with the Department. This led to the issuance of an administrative complaint on February 1, 1988. The complaint charged Dr. Sneij with gross malpractice or with failing to treat the mother and baby with that level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances (Count I), accepting and performing a responsibility for which he was not competent (Count II), inappropriately administering a legend drug (pitocin) not in the course of his professional practice (Count III), failing to obtain Alonso's full, informed written consent to the underwater birthing procedure even though this procedure was experimental (Count IV), and failing to keep written medical records justifying the course of treatment (Count V). The complaint prompted respondent to request a hearing. Underwater Birthing At issue in this proceeding is the so-called underwater birthing procedure used by respondent. It is sometimes referred to as the "Leboyer approach to delivery." Under this procedure, the expectant mother is placed in a tub of hot water at the onset of labor. The baby is eventually delivered underwater in the hot tub. The intended beneficial effect of this procedure is to cause less tension or trauma for the baby since, according to proponents, the baby lives in a "water" environment in the mother's womb, and a delivery into the hot water will be a continuation of the uterine existence. Since the baby still breathes from the umbilical cord, there is supposedly no danger in the baby being underwater for the first few moments of birth. The method is intended to be more relaxful to a mother since the water has a calming effect on the patient and obviates the need for analgesics. There is no recognized, published medical literature on the subject of underwater birthing. However, respondent introduced into evidence three textbooks on the subject for the purpose of showing that such literature existed. None were written by medical doctors from the United States. Underwater birthing originated in Russia in the late 1970's and has been performed in France and perhaps a few other European countries. In this country, several successful underwater births have been performed recently in the State of California. One Board expert characterized the procedure as experimental sinxe there is no scientific evidence to support the claim that the procedure can be safely used. A second Board expert said it was not experimental since it had "been around" for awhile and is now being used "in some (birthing) centers" and in Europe. However, it is not a generally accepted procedure by the medical community in South Florida since, with the exception of respondent, no other area physician uses this form of delivery. Required Procedures During Childbirth In at least 85% of all deliveries, the baby is delivered head first. However, if the legs and buttocks come out first, the birthing is considered a breech delivery. Whether a delivery is normal or breech is a matter of extreme importance since a breech delivery poses more risks to the baby and mother and is more prone to complications. For this reason, the prudent physician always determines the position of the baby prior to delivery. To do this, a physician typically conducts an abdominal and pelvic examination of the patient. If the physician still has any doubt as to the baby's position, an ultrasound may be used. This is a noninvasive sound wave sonar picture which can determine the baby's position with absolute accuracy. If the physician has no ultrasound in his office, the patient should be taken to a facility where such a machine is available. Once the physician determines that a baby is in a breech position, he should recognize immediately the possibility that the mother will have a problem with the descent of the baby and that certain steps should be taken to minimize any risk to the baby and mother. At the same time, the patient should be informed that the baby is in a breech position and certain risks are present and she should have explained the options that are available to her. Most importantly, the patient should be transferred to a hospital setting where surgery can be performed, if necessary, to remove the baby. If a mother is experiencing her first delivery, the baby is at greater risk because the pelvis has not been tested and the pelvic tissues are more resistant to the passage of the baby through the pelvis. Therefore, if a breech delivery is recognized and the patient is in her first pregnancy, the prudent physician should recognize the greater degree of risk and place the mother in a facility where surgical capabilities are available. In some deliveries, the drug pitocin is used to increase the mother's contractions and bring on delivery. Good medical practice dictates that it should never be administered intramuscularly before delivery since the doctor loses control over the effects of the drug once the drug is injected. Indeed, such a practice is considered "a dangerous approach" to the use of the drug since it can cause the uterus to remain contracted in tetanic form thereby cutting off circulation to the placenta. Instead, the drug should be given intravenously to allow the doctor to control the amount given to the patient and to monitor her reactions. Generally, the drug is given in very small increments and gradually increased to achieve the desired uterus contractions. At the same time, the baby's fetal heart rate should be monitored continually by the doctor to verify that the heart rate is not being affected by the strength of the contractions. This can be done by stethoscope or fetal heart machine, either of which is appropriate. It was agreed that the attending physician is the best person to determine when to use the drug. In a normal, uncomplicated breech delivery, the head is usually delivered within five minutes after the actual delivery begins and "almost immediately" after the trunk delivers. If the head does not deliver promptly, steps should be taken by the physician to aid in the delivery of the head by using one's hands or forceps. If a greater than normal time elapses between the delivery of the head and trunk in a breech delivery, the baby runs the risk of being deprived of oxygen, thereby causing brain damage or even death. This is because the umbilical cord may become compressed against the pelvic inlet as the head is coming through the pelvis. Indeed, one expert opined that such compression would occur "in all cases". To determine if compression is occurring, a doctor should monitor the pulsation of the cord and the fetal heart rate. A pulsating cord means the baby is receiving oxygenated blood. In a breech delivery, the patient's head must be kept flexed in a certain direction to facilitate delivery. Further, a physician has more difficulty in performing the manipulations required if complications arise. These difficulties are exacerbated if the delivery occurs in water. If a baby is "limp" after breech delivery and has a low Apgar score, it is standard procedure for the physician to immediately institute resuscitative measures. This is done by first clearing the airway, administering oxygen and then supporting the baby by artificial ventilation. This latter step is accomplished generally by clearing the airway and giving oxygen under pressure. The standard practice in the Miami area is to deliver large babies by Cesarean section if a breech position is noted. However, not all breech babies are delivered surgically. The Actual Incident Marlene Alonso, then twenty-three years of age, became aware of respondent in early 1987 after reading respondent's advertisement concerning the water birthing procedure. The advertisement appeared in a magazine sold at a local health food store. She was then two months into her first pregnancy. After making an appointment, Alonso met with Dr. Sneij, viewed several tapes of water birthing deliveries and had a "consultation". At the first meeting, respondent told Alonso that the procedure was developed in Eastern Europe and was "common" over there, that this method of delivery was "less stressful" for both mother and baby, and that it was less risky than other forms of childbirth. He did not require Alonso to sign a consent form. Alonso chose respondent as her physician because she had no insurance and insufficient funds to have a hospital birth. Also, she was satisfied the procedure was safe even though she knew respondent was the only doctor in Florida using this procedure. Her satisfaction was based upon respondent's representations and reinforced by her husband's cursory research on the subject which included reading a newspaper article at a local library concerning such deliveries being performed by midwives in California. The Alonsos did not consult any other physicians about the procedure. Alonso visited respondent once a month for the first few months, then biweekly and finally once a week in the final stages of her pregnancy. During her visits, Alonso sometimes asked if the baby was positioned head first and Dr. Sneij always responded that everything was "fine." Indeed, after several visits, Dr. Sneij noted in his medical records that the baby was "head down." Respondent has a small office on South Beach in Miami Beach consisting of several rooms. The largest room measured around 12' x 16' and had a hot tub used for underwater birthing. Doctor Sneij used this room for his deliveries. Although the room had shelves on which medicine was stored, no medical equipment, such as oxygen or operable monitoring equipment, was maintained on the premises. When the events herein occurred, two secretaries worked at the office. Alonso's onset of labor began on the evening of Sunday, November 1, 1987. She arrived at respondent's office around 11:00 p.m. that evening with her husband. After respondent gave her an enema, she was placed in a hot tub where she remained for most of the night. As was customary with respondent's office birthings, he taped a part of the birthing with a video camera placed near the tub. A copy of the video tape has been received in evidence as petitioner's exhibit 1. Present during all or part of the delivery were Alonso's husband, her parents, sister-in-law, Dr. Sneij, his wife (who he said acted as his assistant) and two young children, a secretary and a friend who taped part of the delivery. During the first twenty-four hours, Alonso received one injection of demoral for pain and was given occasional sips of honey water. She and the fetus were periodically checked by respondent with a stethoscope during this time. At around the twenty-hour point, Dr. Sneij advised Alonso the baby "might be" in a breech position. However, he confirmed this in a conversation with Alonso's mother-in-law, and his medical notes recorded earlier that day reflected that the "fetus was in breach (sic) presentation." Respondent then advised Alonso that she should be transported to a hospital for a "C-Section". Although respondent had no hospital privileges, and Alonso no insurance, he nonetheless attempted to get Alonso placed in a local hospital. When he met with no success, respondent returned and told everyone he was waiting for a doctor at Jackson Memorial Hospital to return a call. After examining Alonso's abdomen with a stethoscope, Dr. Sneij remarked that the baby had a "strong heartbeat," that by a "miracle" its head was "down" and not in a breech position, and that hospitalization would not be required. He then "guaranteed" Alonso would have no problems. This occurred around the twenty-four hour mark. At one point, Alonso requested that respondent hook up his fetal heart rate monitor to her but respondent said he was out of paper. Alonso desired the paper printout as a souvenir for her baby. To hasten the delivery, and in response to Alonso's pleas to do something, respondent injected pitocin intramuscularly into Alonso on three occasions, the first time around 10:00 p.m. on November 2. According to respondent's medical notes, the first dosage contained "3 units". At midnight, respondent gave a second injection containing "3.5 mg." of pitocin. Two hours later, Alonso received a third injection containing 3.5 units of the drug. Alonso's delivery began around ninety minutes later. When the actual delivery began around 3:30 a.m. on November 3, or after thirty-three hours of labor, Alonso was half standing and leaning over in the tub of water. Dr. Sneij remarked that "the head is out." However, the legs and buttocks of the baby delivered first. From a kneeling position in the tub beneath Alonso, Dr. Sneij continued to manipulate the baby with his fingers in an effort to complete the delivery but the head did not pass out of the vaginal canal until some twenty-two minutes later. The baby, which weighed eight pounds twelve ounces and was considered "large", was held under water for a few moments and then placed on the mother's abdomen for a few seconds. All the time Dr. Sneij kept feeling the cord. After observing that the baby was purple and not moving, he took her back, wiped "stuff" out of the baby's mouth and began adminis-tering mouth-to-mouth resuscitation. At that point, Alonso called out for someone to telephone 911 for an emergency vehicle but respondent said "no." Even so, Alonso's father telephoned for an ambulance. When the 911 team arrived, one of the technicians immediately cut the umbilical cord. After respondent inserted an endotracheal tube in the baby's throat, and while he continued mouth-to-mouth resuscitation, the baby and mother were transported to Mount Sinai Hospital. The baby remained on a life support system for seventeen days until the system was turned off. It was brain dead during this entire period of time. The actual cause of death, as determined by autopsy, was dystocia, which, according to the medical examiner, meant a difficult childbirth caused by the head not getting out of the vaginal canal in a prompt, normal fashion. In his medical records, Dr. Sneij characterized the complication as "respiratory dysfunction, in otherwise normal baby" and that this complication "could be caused by an adverse drug action, or reaction most probably due to pitocin." However, he did not rule out "other factors that were not known to (him)." Adequacy of Medical Records Respondent's medical records relating to the incident have been received in evidence as petitioner's exhibit 2. Since there was no expert testimony concerning their adequacy in terms of justifying Dr. Sneij's course of treatment of the patient, the contents of the exhibit need not be repeated herein. E. Competency or Disaster? Testifying on behalf of the Board were three physicians. They included Dr. Nathan B. Hirsch, a Coral Gables obstetrician and gynecologist since 1971 and one-time professor at the University of Miami Medical school, Dr. Allan G. W. McCleod, an obstetrician and gynecologist who has taught that subject at the same medical school since 1960, and Dr. Roger Mittleman, an associate medical examiner for Dade County and board certified in forensic pathology and anatomical and clinical pathology. Respondent, who is a licensel medical doctor, testified on his own behalf. As might be expected, petitioner's witnesses and respondent reached sharply conflicting conclusions regarding respondent's skill and competency while treating Alonso. However, no expert ventured an opinion as to respondent's competency outside the area of obstetrics or whether respondent was incompetent to initially accept Alonso as a patient to provide prenatal care and assist in the delivery. Appropriate findings regarding this testimony will be made below. As a starting point, Dr. Hirsch viewed petitioner's exhibit 1 in its entirety. That exhibit is a video tape of part of Alonso's delivery. Characterizing the tape as an "outrageous, horror movie," Dr. Hirsch concluded that Dr. Sneij's conduct constituted a "dramatic deviation from the standard of care in (not only the Miami) community," but "any community in the world." Doctor Hirsch noted first that Alonso's labor lasted around thirty-three hours which was "excessive" by any standards. The expert pointed out that Dr. Sneij deviated from generally accepted practice by injecting pitocin intramuscularly into Alonso on three occasions in amounts of one hundred and one hundred and fifty milligrams. This was contrary to the accepted practice of administering the drug intravenously in small increments so that the doctor can control the amount being given to the Also, Dr. Hirsch did not observe respondent monitor the baby's heart rate after the injections. Doctor Hirsch noted also that even though respondent recognized the baby in a breech position some six to eight hours after the onset of labor, and knew this was Alonso's first pregnancy, he continued the delivery process in an office setting. According to the expert, a prudent physician would have recognized the risks of this setting and transferred the patient to a high-risk obstetrical center with the capability of performing surgery if needed. By respondent failing to do so, Dr. Hirsch concluded Dr. Sneij's actions constituted a deviation from the standard of care. Doctor Hirsch did not observe any visible evidence of "sterile technique" in respondent's office. Further, Dr. Hirsch opined that respondent should have had, at a minimum, electronic monitoring equipment and the necessary equipment to perform emergency surgery if the need arose. At the time of delivery, as depicted on the tape, the expert observed the delivery of the legs and buttocks to the baby's umbilicus. He saw then the bottom portion of the baby hanging from the vagina with respondent's hands on the buttocks and legs for some twenty-two minutes until the upper half delivered. According to Dr. Hirsch, this time frame was of dramatic medical significance since, in a breech delivery where the baby is delivered to the umbilicus, the baby must be out of the canal within one minute or suffocate. The witness concluded the baby was dead within five to eight minutes after the lower half delivered. Doctor Hirsch opined also that during the lengthy delivery, respondent did not appear to understand or use proper delivery techniques that would have hastened the delivery. However, he did not elaborate on what specific techniques should have been used. After the baby was delivered, Dr. Hirsch concluded that respondent erred by holding the baby underwater for about two minutes. According to the expert, respondent should have taken the baby to a nearby delivery table and attempted to resuscitate the baby. Also testifying for the Board was Dr. Allan Gordon Walker McCleod, an obstetrician/gynecologist and a member of the faculty at the University of Miami Medical School since 1960. As did Dr. Hirsch, the expert viewed petitioner's exhibit 1, which is the tape of the delivery. Doctor McCleod concluded that respondent did not meet the community standards of care when he failed to accurately determine the presentation of the baby at the outset of labor. He pointed out further that, during the delivery itself, he saw no evidence of Dr. Sneij monitoring the baby's fetal heart rate or the pulsation of the cord. According to Dr. McCleod, both steps should have been taken here, particularly in light of the lengthy time (22 minutes) between the delivery of the trunk and the head. The expert also criticized respondent's efforts to perform a breech delivery in a hot tub. This was because the patient was in a sitting position on the slide of the tub making it difficult for the doctor to perform the required manipulations. Further, the tub made it difficult for respondent to adequately monitor the baby during the delivery. Doctor McCleod criticized next the administering of pitocin to Alonso prior to delivery as being contrary to the standard of care. He noted that such a practice is not used in "present-day obstetrics", is "dangerous" to the patient and baby, and that such risks should be "common knowledge" to all physicians. He observed finally that after administering the pitocin, respondent did not record the length of contractions or fetal heart rate to determine the patient's response to the drug. The expert concluded that Dr. Sneij acted improperly by keeping the baby underwater "for a long period of time" once it delivered even though it was "very limp", "hypoxic" and had very little muscle tone. Even after it was removed from the water and placed on the mother's abdomen, Dr. McCleod noted that respondent still made no effort to resuscitate the baby. When respondent finally instituted resuscitative measures, Dr. McCleod observed no effort by respondent to clear the airway or to use mechanical ventilation. In summary, Dr. McCleod concluded respondent was negligent by giving a lack of prenatal care, by failing to timely recognize an abnormal presentation, by failing to properly handle labor, by inappropriately administering a legend drug, and by failing to make proper efforts to resuscitate the infant. He recommended that respondent not be allowed to practice obstetrics until Dr. Sneij received further training in that area. The final Board expert was Dr. Roger Mittleman, an associate medical examiner for Dade County who has performed over 3,300 autopsies in his career. Doctor Mittleman performed an autopsy on the Alonso baby and concluded that the cause of death was dystocia brought about by the head not getting out of the vaginal canal in a timely manner. According to Dr. Mittleman, the baby was born brain dead due to a lack of oxygen to the brain during the twenty-two minute delivery. Although the heart was still beating when the baby delivered, Dr. Mittleman said the baby was dead for all practical purposes. Respondent testified on his own behalf and generally denied all allegations. He had no opinion as to the cause of the baby's death and denied his actions contributed in any way. Respondent acknowledged he knew from the outset of labor that the baby was in an abnormal presentation but said this gave him no concern since the patient was young and healthy, and breech deliveries were not always complicated. Also, he had no concern over the length of labor (33 hours) since he had performed several other water births where labor consumed around ninty hours. As to the administering of pitocin intramuscularly, Dr. Sneij contended he recognized the risks of the drug but that he minimized any risk by injecting it in small doses. In addition, he denied that there was an inordinate length of time between the delivery of the trunk and the delivery of the head. In that vein, he opined that because Alonso had been in labor for a long time and had dilated well, the possibility of cord compression was "zero or near zero." Also, he pointed out that he repeatedly felt between the baby and the vagina and could not feel "severe pressure." According to respondent, the cord was of "good size" and was continually pulsating throughout the entire delivery. Respondent assumed the baby was merely "tired of birth" after it fully delivered, and for this reason, left her in the water "for about a minute." When he realized resuscitative measures were needed, which he says were due to "birth trauma," Dr. Sneij claims he did all he could for the baby and, by turning the baby upside down, he cleared the baby's airwave by force of gravity. Finally, if he were presented with the same case again, respondent said he would not do anything differently. Although respondent is not board certified in any specialty, he characterizes his experience as being "very wide." When he first came to the United States, his primary interest was in orthopedic surgery. He subsequently developed an interest in obstetrics, but stated he had no opportunity to engage in that type of practice until he delivered his own first child. In all, Dr. Sneij represented he has delivered some twenty-four babies during his career, including the last eight by underwater birthing. One of those eight was his own. After considering all of the testimony herein, the testimony of experts Hirsch, McCleod and Mittleman is accepted as being more credible and persuasive than that of respondent. Accordingly, it is found that respondent failed to conform with the statutory standard of care by failing to timely recognize the baby's presentation, by failing to timely send Alonso to a hospital setting, by improperly managing the labor, by inappropriately administering pitocin to the patient, by having inadequate equipment at his office, and by failing to promptly take steps to resuscitate the baby after delivery.
Recommendation Based on the foregoing finding of fact and conclusions of law, it is RECOMMENDED that respondent be found guilty as charged in Counts I, II, and III and that all other charges be DISMISSED. It is further recommended that the penalty set forth in paragraph 49 of the conclusions of law be imposed. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 4th day of November, 1988. DONALD R. ALEXANDER Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 Filed with the Clerk of the Division of Administrative Hearings this 4th day of November, 1988. APPENDIX RESPONDENT: 1-3. Covered in finding of fact 14. 4-5. Covered in finding of fact 15. Covered in finding of fact 4. Covered in finding of fact 15. Covered in finding of fact 17. Covered in findings of fact 18 and 26. 10 Covered in finding of fact 36. Partially covered in finding of fact 7. The remainder is rejected as being contrary to the more credible and persuasive evidence. Partially covered in findings of fact 7 and 20. The last sentence is rejected since it is contrary to the more persuasive evidence that pitocin be given in small increments intravenously. Rejected as being irrelevant since the statute does not require that an actual injury to the patient occur by virtue of a physician's inappropriate conduct. Covered in finding of fact 9. Covered in findings of fact 18 and 21. Covered in finding of fact 9. Covered in finding of fact 21. Covered in finding of fact 10. Rejected as contrary to the more persuasive evidence that this was an abnormal delivery. Covered in finding of fact 21. Covered in finding of fact 36. Covered in findings of fact 21 and 36. Covered in finding of fact 22 except that while the heart was still beating, the baby was brain dead at delivery. Covered in finding of fact 38. Covered in finding of fact 34. Covered in finding of fact 24. COPIES FURNISHED: William O'Neil, Esquire 151 Crandon Boulevard, No. 125 Key Biscayne, Florida 33149 Harold M. Braxton, Esquire Suite 406 9100 South Dadeland Boulevard Miami, Florida 33156 Dorothy Faircloth, Executive Director Board of Medicine 130 North Monroe Street Tallahassee, Florida 32399-0750 Bruce D. Lamb, Esquire General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 =================================================================
