Findings Of Fact At all times pertinent to the allegations herein, the Petitioner, Board of Medicine, was the state agency in Florida charged with the licensing and regulation of physicians in this state. Respondent, Dr. Lewis Sidney Wolf, was at all times pertinent licensed as a physician in Florida. Dr. Wolf took his medical degree at the university of Bologna, in Italy, and thereafter did his internship and residency training at hospitals in New York. He has been in the private practice of obstetrics and gynecology since 1977 and though not Board certified, has limited Board eligibility. Upon completion of the required continuing medical education courses he will be eligible to sit for the Board examination. He was employed as a physician at the Aware Woman's Medical Center, (Center), an abortion clinic in Port St. Lucie, Florida, from May, 1987 to October 8, 1990. During that time he had no responsibility for administration or the business affairs of the Center. On January 5, 1990, he saw L. S., (Patient 1), a 19 year old rather tall woman on whom he had done a previous abortion, who had come in for termination of another pregnancy. He recalls her as being normal both mentally and physically. His physical examination of the patient consisted of listening to her heart and lungs and doing a bi-manular pelvic examination. This includes placing one hand in the patient's vagina to feel the cervix and the other hand on the patient's abdomen at the top of the uterus. By doing this, the physician can see how big the uterus is and feel for any abnormality caused by pregnancy or fibroids. Respondent's examination of this patient showed she had a regular, smooth and symmetrical, if large, uterus. Since other tests had shown she was pregnant, he decided to terminate it at her request. Respondent's initial examination caused him to estimate the fetus size was larger than 9 weeks. He therefore suggested the patient be given a sonogram to determine with some accuracy how big it was. However, since the patient was so tall, and this can be deceiving as to uterus size, and because his assistant, Candace Dye, the clinic administrator who, incidentally, had no medical training, disagreed with him, and because the procedure was already scheduled and a sonogram, which had to be done outside the office, would be costly to the patient and would interfere with the scheduled procedure, he checked the patient again and concluded the fetus size was only 9 weeks. Since he felt that maybe the untrained layman was correct and since the termination procedure was the same up to 14 weeks as it was at 9 weeks, he assumed responsibility and decided to go ahead with the termination using a dilation and curettage. In this procedure, metal rods of increasing size are inserted into the cervical opening to dilate it after which a plastic tube with a hole on the side, (a cannula) is inserted into the uterus to remove the fetus by means of a vacuum aspirator, (suction). This procedure is not generally used to terminate a pregnancy of longer than 14 weeks. Page 10 of Petitioner's Exhibit 2, the patient records from the Center, reflect that Respondent's initial estimate of fetal size, as recorded by the nurse, was greater than 12 weeks and the Respondent at first ordered a size 12 cannula. However, after the cervix was dilated, Respondent ordered a 14 cannula because during dilation he felt the fetus was larger than anticipated. After the first aspiration, Respondent felt there was still some tissue left in the uterus and inserted the cannula again to get it. At this point, Respondent noticed some yellow fatty material in the aspirator which he believed came from the omentum, the outside of the uterus, and he believed that the cannula head had gone through the side of the uterus at the site of a scar from a previous caesarian section, (the patient had had two previous caesarian sections). This is the place where, according to Respondent, most perforations occur due to the weakening of the uterus as a result of those procedures. In the interim period between the removal of the cannula after the first insertion and the second insertion, because he could not get all the tissue out during that first insertion, Respondent used a placenta forceps to get the bony part of the fetus, (an arm), which would not go through the cannula. He then used the cannula the second time and cannot be sure if it was the forceps or the second application of the cannula that caused the perforation. In any case, when he realized that a perforation had occurred, he packed the uterus with gauze and called 911 to have the patient taken to the hospital. She subsequently recovered but lost one tube. Patient 2, a 41 year old female, reporting two prior deliveries, came to the Respondent for a pregnancy termination on October 28, 1989. At the time, she seemed quite nonchalant about the whole process. She reported having a fibroid uterus and claimed to have had a recent sonogram which showed a "VBD" of 5.1. The term "VBD" is incorrect for use in connection with a sonogram. The appropriate initials are "BPD", bi-parietal diameter, and a BPD of 5.1 correlates to a fetus age of in excess of 21.5 weeks. The patient also indicated that she had only had sexual relations twice in several years, the last of which was consistent with a pregnancy of far less duration that 20 weeks. Respondent did a bi-manular examination and estimated from that a gestational age of the fetus of 20 weeks. However, the patient's forms showed a sonogram had been done on October 21, 1989 and the uterus size given as a result thereof was 9. Respondent claims his estimate of 20 was for the uterus size, not the fetus size, and this is not inconsistent with the diagnosis of fibroid uterus which could, of itself, considerably increase the size of the uterus. In addition, Respondent claims his examination showed the uterus to be firm and in pregnancy, the uterus generally gets soft. Based on all the above, and given the fact that the Patient could not recall where the sonogram had been done, and the fact that she seemed reliable to him, Respondent concluded that the pregnancy was of only 9 weeks duration and agreed to terminate it by dilation and curettage. His description of the patient as reliable is not consistent with his other comments regarding her at the hearing wherein he described her as inconsistent and mixed up. In retrospect, at the hearing, he admitted he now realizes she was lying to him. As Respondent was preparing the patient for the procedure, he noted on her chart that the sonogram showed 5.1. This figure represents the diameter through the head of the fetus. He did not have a chart handy from which to extrapolate the sonogram figure to a fetal age. He asked his assistant, Michelle Trent Wimble to check it. She left the room and when she came back reportedly stated, "It's OK - it's only 11 weeks." In reality, Ms. Wimble did not look at the correct chart and the information she gave to the Respondent was incorrect. He did not verify it. In the termination, Respondent started with a size 12 cannula. Once the vacuum was initiated with that cannula, he shifted to a 14 and then requested a placenta forceps. He changed the size because, he asserts that once the patient was dilated, he realized the fetus was larger than he had anticipated and needed the larger size. Also, when he saw the amniotic sac he knew the pregnancy was further along than 11 weeks but because he was committed and could not let the patient go home like that, he had to continue. He broke the sac and tried to vacuum with a 16 mm cannula, the largest made, but was still unsuccessful. He then tried the forceps. When he saw the umbilical cord had prolapsed, and had removed a hand from the fetus, he knew it was much older than anticipated. Since it was obviously beyond the 14 weeks menstrual limit the Center set for abortions there, he called 911 to have the patient taken to the hospital for completion. Respondent has specialized in abortions not only for his 3 years at the Center, but at other clinics in New York, Tampa and Ft. Myers, where he filled in for another physician whose license was under attack. He has done over 5,000 abortions and claims to have experienced complications in only 4 of them. Each of these involved perforations of the uterus. According to Ms. Dye, who worked with Respondent for the three years he was at the Center, his problem rate was low. A perforation may occur as the result several different factors such as a tilting of the uterus or frequent prior pregnancies which weaken or soften the wall of the uterus. A perforation is also more likely in a woman who has had one or more caesarian sections. It is not necessarily due to negligence on the part of the physician though it may be. According to Respondent, most often it is not negligence but more a complication which occurs because of the anatomical arrangement of the pelvic organs. With regard to Patient 1, Respondent feels he did nothing wrong. Her records show that from her last menstrual period she would be 11 weeks pregnant based on her last period date of November 1, 1989. Also, from her history sheet he notes 2 reasons for her being a higher risk patient. She had had two caesareans sections and one prior abortion. She was 19 years old and had had 5 pregnancies. Therefore, he claims, her uterus had not had time to rest and could easily be perforated. In addition, as a result of his examination, he was quite comfortable with a 9 weeks fetal determination. Though she might have been slightly over that she was still within the limits for a suction abortion. He is also comfortable having done the bi-manual examination which he feels is generally reliable. Factors such as a tall patient can throw it off, however, he claims. With regard to Patient 1, Respondent claims there was nothing about her to alert him to danger. It is not usual to change cannulas in mid- procedure. It is done from time to time, especially in the first pregnancies of young women whose cervix are hard to dilate. He also claims it is not unusual to over or under estimate a pregnancy by 2 weeks. It is impossible to tell exactly how many weeks a patient is pregnant. Respondent admits a patient history sheet is important and it is important that the patient give honest information for it. Erroneous information from any source, if relied on by the physician, can result in injury to the patient. Patient 2 was a 41 year old woman at the time he saw her. This fact makes her a high risk patient for carrying the fetus to term. From the last menstrual period she reported, she would be 12 weeks pregnant. The sonogram results as passed to the Respondent was consistent with 11 weeks of pregnancy and with the menstrual history. Assuming her sexual history were correct, she could be no more than 16 weeks pregnant. Because the patient referred to a "VBD", similar in sound to "BPD", the correct term, Respondent considers it was reasonable for him to believe she had had a sonogram. Here, however, the Respondent stated at one point that at that time he did not believe her and if that is the case, it was improper for him to do the procedure on a patient who he did not believe had given him a correct history. Further, when a patient shows a history of prior pregnancies or caesarian sections, admittedly that patient is at a higher risk of perforation and the doctor should be more cautions and more prepared than otherwise. Respondent's performance in the two cases at issue here was reviewed by Dr. Edward J. Zelnick, himself an expert in the field of obstetrics and gynecology, who has done numerous pregnancy terminations in the past. His review consisted of an examination of the clinic and hospital records of both patients. In order to safely and properly terminate a pregnancy, it is necessary for the physician to know the size of the fetus. This can be determined by the history taken from the patient, by physical examination of the patient, including both palpation and bi-manual manipulation, and by sonogram. In the case of patient 1, Respondent performed a suction curettage. Before doing so, he accomplished a bi-manular examination and determined the fetus was 9 weeks of age. The records reflect that initially an ultrasound, (sonogram), was requested, but that order was rescinded. In the suction curettage the cervix is dilated with metal rods of increasing diameter and the cannula is then inserted to remove the fetus by suction. The size of the fetus determines the size of the suction tube to be used. Here, Respondent selected an 11 cannula which can be used generally with fetuses from 9 to 11 weeks of age. The records reflect that little tissue was obtained through the use of the cannula, so Respondent asked for and used a larger one. After the size of the cannula was increased, a placental forceps was used to remove a fetal extremity and a portion of the oventum, (a portion of fact attached to the intestine not generally found in the uterus). The presence of the oventum indicates that the wall of the uterus was perforated. Dr. Zelnick feels this perforation could have been avoided if more care had been utilized in the determination of the fetal size. There appeared to be a discrepancy between the appearance and the actual size and duration of the fetus. If the size was, as here, underestimated, the larger actual fetus prevented the doctor from getting the amount of tissue he expected. This could lead him to go deeper or in a different direction that she should go to get tissue. In light of this, Dr. Zelnick opined that the level of care rendered to Patient 1 by the Respondent was below standard because the final outcome and the manner of performance is not properly reflected in the records. Also, the wrong size instruments were used. Most important, however, is the failure to properly determine the size of the fetus. If the doctor is unsure of the fetal size, he should take further steps, through ultrasound or otherwise, to be more specific. Here, in Zelnick's opinion, the perforation occurred when the Respondent went into the uterus with the placental forceps. Once the perforation was noted, Respondent properly had the patient taken to the hospital where her abdomen was opened and her right fallopian tube and ovary were removed. In addition, her uterus was repaired. All this resulted in her being exposed to risk due to anesthesia, infection and hemorrhage. In addition, she unnecessarily lost her tube and ovary due to the bleeding caused by the perforation. Since she now has only one tube and ovary, there is a possible diminishment in future fertility, but there is some doubt as to that happening. As to Patient 2, according to Dr. Zelnick, the Respondent established she was 9 weeks pregnant. The records show the result of the bi-manual examination showed 9 weeks, but they also reflect the patient had a sonogram and to Dr. Zelnick, it is unclear because the record of the sonogram showed a 5.1 BPD which is consistent with a 20 - 22 week pregnancy. In addition, the patient gave a history of only 2 sexual relations prior to the visit which is inconsistent with the other findings since the last intercourse would have been to 15 weeks prior to the visit which would not fit with a 9 week fetus finding. The nurse's note on the patient records indicate the only information the patient could give was that the sonogram showed a 5.1 LMP [sic]. In this case, Respondent also did a suction curettage initially using an 11 cannula. He then requested a 12 cannula and almost immediately went to a 14 which he then increased to a 16 which would be used for a 14 - 16 week fetus. When he failed to get an adequate tissue return, he used a placental forceps and saw a fetal extremity and umbilical cord. When he saw this, he realized the pregnancy was further advanced than expected and stopped the procedure and called for emergency services. This patient was also given an injection of Petosin, a drug used to contract the uterus, and an intravenous was attempted. She was taken to the hospital and treated for hemorrhage, hypertension and shock, and failure of her blood to coagulate. Hypertension is consistent with blood loss and it was subsequently noted in surgery that the patient had a uterine perforation. The patient was given an exploratory laparotomy and a total abdominal hysterectomy. The danger of anesthesia, infection, hemorrhage, and the loss of fertility as a result of the removal of her uterus are all negative results of the procedure. Dr. Zelnick is of the opinion that Respondent's treatment of patient 2 was below acceptable standards because the Respondent had an obligation to be certain of the age of the fetus before initiating action and did not do so. His omissions led to an unfortunate series of events which injured his patient. In fact, Dr. Zelnick goes so far as to classify Respondent's actions as gross negligence. The relative sizes of a 9 week and a 22 week fetus is so disparate that such a mistake as here is not reasonable. While a 9 week fetus is about the size of an orange, a 22 week fetus is about the size of a volley ball. While the existence of a uterine fibroid cyst can make the determination of fetal size more difficult, a doctor can make the determination. A fibroid cyst is hard and solid while a fetus is soft. In any case, if there is a question, a sonogram should be done. If the physician cannot be absolutely sure of the length of gestation by examination or history, he should take all necessary other steps to find out. If he does not, his failure constitutes negligence. Here, especially, the inconsistent BPD value, a figure with which any doctor routinely doing abortions should be familiar, should have tipped Respondent off to the need for more information. In addition, according to Dr. Zelnick, the Respondent's record keeping was poor. They do not accurately reflect or justify the procedures done on this patient. Dr. Zelnick admits that a uterine perforation is a complication which can occur without negligence on the part of the physician. Certain conditions, including an abnormality of the uterus can increase the risk, and by itself, a perforation is not necessarily bad care. If a patient has had 2 prior caesarian sections and 3 pregnancies, an attending physician could easily be slightly off in the age of the fetus. However, a doctor, as here, who does many abortions should be better at estimating the length of a pregnancy than one who does fewer. Respondent's expert, Dr. Dresden, also a Board certified obstetrician and gynecologist, who has performed over 10,000 abortions during his medical career, appeared on Respondent's behalf because, inter alia, he believes there is a grey area in the practice of medicine to which, in his opinion, the Department is not sensitive. It does not recognize differing methods of practice. He also contends that the mere fact a complication occurs which must be reported does not justify an indictment of the practitioner. Disciplinary action, in his opinion, should be reserved for cases of misconduct. As to Patient 1, Dr. Dresden feels that bi-manual examinations are quite difficult to do and are quite often inaccurate as to the length of gestation. The mistake made by Respondent here, as to the size of the fetus, is common. As to Patient 2, Dr. Dresden could see no reason for another ultrasound being taken. The government does not normally reimburse for it, and if, as here, he had found the incorrect estimate had been made and the instrument he was employing was too small, he'd go on with the procedure with a larger instrument. The is no relationship between the mis-diagnosis of size of the uterus and the risk of perforation except that there would be a greater weakness in the uterine wall in the case of a 20 week pregnancy. However, even a prudent doctor could end up perforating the wall of a uterus for a myriad of reasons. The position of the uterine cavity may be out of line, and if the instrument is not properly lined up, there is a greater risk of perforation. Also, a pregnant woman has softer uterine walls that are more easily perforated than a non- pregnant woman. Dr. Dresden could see nothing that Respondent could have done to avoid the perforations here nor does he believe Dr. Zelnick could accurately determine, from looking at the records, what instrument caused the perforation. If Patient 2 said she had had an ultrasound, he probably would have believed her. Most patients do not know enough to make up a story like that, he believes, and if he saw a record that the BPD was 5.1, he would ask a nurse or an assistant to look up the meaning of that reading and would rely on it. Here, based on what information he had about Patient 2, the 4 factors he took into consideration being better than the usual 2, he believes Respondent could have reasonably relied on the stated size of the fetus. He cannot say that Respondent used poor judgement in these cases notwithstanding his comment to the contrary in a prior letter to the Department regarding this case. By the same token, he cannot see any errors in Respondent's performance other than the mis-diagnosis of fetal size. The witness' prior professional record and his obvious antipathy toward the enforcement activities of the Department, cast some doubt on the value of his testimony, however. No evidence was presented with regard to the medical records of either patient in issue here to bear on the issue of their adequacy or inadequacy. Dr. Zelnick commented on his opinion that the records were poor, but no specific evidence of inappropriate recordation of the patients' conditions or other relevant matters was submitted to show them to be inadequate.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that Respondent's license to practice medicine in Florida be suspended for a period of six months and until such time as he has satisfactorily completed the special purpose examination of clinical skills; that upon reinstatement of his license, he be placed on probation for a period of two years under such terms and conditions as is considered appropriate by the Board of Medicine; and that he pay a fine of $1,500.00 within six months of the reinstatement of his license. DONE and ENTERED in Tallahassee, Florida this 17th day of December, 1991. ARNOLD H. POLLOCK Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 17th day of December, 1991. APPENDIX TO RECOMMENDED ORDER IN CASE NO. 91-2969 The following constituted my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all the Proposed Findings of Facts submitted by the Petitioner herein. Respondent failed to submit Proposed Findings of Fact. FOR THE PETITIONER: 1. & 2. Accepted and incorporated herein. 3. - 10. Accepted and incorporated herein. 11. & 12. Accepted. Rejected. - 27. Accepted and incorporated herein. Rejected in that the Respondent's failure to ascertain the results of the sonogram is not evidence of poor record keeping. Rejected in that Respondent's failure to ascertain the gestational age of the fetus when facing conflicting information is not evidence of poor record keeping. & 31. Accepted and incorporated herein. COPIES FURNISHED: Larry McPherson, Esquire Department of Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792 Dr. Harold J. Ticktin 2106 Drew Street, Suite 102 Clearwater, Florida 34625 Jack McRay General Counsel DPR 1940 North Monroe Street Tallahassee, Florida 32399-0792 Dorothy Faircloth Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue Whether Respondent, a medical doctor, violated Section 458.331(1)(m), Florida Statutes, as alleged in Count I of the Administrative Complaint and, if so, the penalty or penalties that should be imposed. Whether Respondent violated Section 458.331(1)(t), Florida Statutes, as alleged in Count II of the Administrative Complaint, and, if so, the penalty or penalties that should be imposed.
Findings Of Fact Effective July 1, 1997, Petitioner is the agency of the State of Florida charged with regulating the practice of medicine pursuant to Section 20.34, Florida Statutes, and Chapters 455 and 458, Florida Statutes. Pursuant to the provisions of Section 20.43(3), Florida Statutes, Petitioner has contracted with the Agency for Health Care Administration to provide investigative and prosecutorial services required by the Division of Medical Assurance, councils, or boards, as appropriate. Respondent is and has been at all times material hereto a licensed physician in the State of Florida, having been issued license number ME 0053773. Respondent has been board-certified in radiology since 1989. In 1995, at the time of the screening mammogram at issue in this proceeding, Respondent was a radiologist at Fisherman's Hospital in the Florida Keys. At the times pertinent to this proceeding, Respondent and Fisherman's Hospital used a classification system to describe the results of mammograms. That classification, developed by the American College of Radiology in 1992, is referred to as BI-RADS, which is an acronym for Breast Imaging Reporting and Data System. The following six categories are used: Category 0: Need Additional Imaging Evaluation: Finding for which additional imaging evaluation is needed. This is almost always used in a screening situation and should rarely be used after a full imaging work up. A recommendation for additional imaging evaluation includes the use of spot compression, magnification, special mammography views, ultrasound, etc. Category 1: Negative: There is nothing to comment on. The breasts are symmetrical and no masses, architectural disturbances or suspicious calcifications are present. Category 2: Benign Finding: This is also a negative mammogram but the interpreter may wish to describe a finding. The interpreter might wish to describe findings while still concluding that there is no mammography evidence of malignancy. Category 3: Probably Benign Finding - Short Interval Follow-Up Suggested: A finding placed in this category should have a very high probability of being benign. It is not expected to change over the follow-up interval, but the radiologist would prefer to establish its stability. Data are becoming available that shed light on the efficacy of short interval follow-up. Category 4: Suspicious Abnormality - Biopsy Should Be Considered: There are lesions that do not have the characteristic morphologies of breast cancer, but have a definite probability of being malignant. The radiologist has sufficient concern to urge a biopsy. Category 5: Highly Suggestive of Malignancy - Appropriate Action Should Be taken: These lesions have a high probability of being cancer. On August 10, 1994, Dr. Sheldon Kushner referred his patient, P. D., to Fisherman's Hospital for a routine screening mammogram. The mammogram was interpreted by Dr. Wayne Moccia, a radiologist. Dr. Moccia's report reflected a dense fibroglandular pattern and scattered microcalcifications in both breasts. No masses or densities were identified. Dr. Moccia recommended a follow-up mammogram in six months for comparison if no prior mammogram was available. On July 21, 1995, Dr. Kushner referred P. D. to Fisherman's Hospital for a follow-up screening mammogram. Respondent was the radiologist who directed the taking of the mammogram views and subsequently interpreted them. Respondent performed two standard screening mammogram views for each breast - the cranial caudial view and the medial lateral oblique view. There is no allegation that these views were inappropriate. Respondent compared the results of the July 1995 mammogram to the results of the August 1994 mammogram and thereafter prepared a report, dated July 21, 1995. 2/ Respondent's report reflects that routine bilateral mammogram views were taken of the patient. The following reflects Respondent's findings: Comparison is from 8-10-94. There are several small clusters of calcifications, particularly in the left breast. The overall breast parenchymal density is increased, as before. No discrete mass. No change in the morphology of the calcifications. Under the part of the report marked "Conclusion", the following appears: Stable calcifications. As some of these are indeterminate in morphology, I would recommend a bilateral follow-up in one additional year to ensure continued stability. (Category 3). The reference to Category 3 is to the BI-RADS classification. According to Dr. Kushner's records, which were admitted into evidence without objection, P. D. was examined by Dr. Kushner on July 27, 1995. Dr. Kushner found P. D.'s breast examination to be within normal limits. P. D. returned to Fisherman's Hospital for a screening mammogram on August 14, 1996. At that time, Dr. Moccia compared the mammogram view taken on that date with the mammogram views taken August 1994 and July 1995. Dr. Moccia detected abnormalities which led him to conclude that there was a strong suspicion for malignancy of P. D.'s left breast. Dr. Moccia classified the 1996 mammogram as a Category 5 and recommended a biopsy. It was subsequently determined that P. D. had cancer in her left breast. There was a conflict in the evidence as to whether Respondent's interpretation of P. D.'s 1995 mammogram fell below the standard of care. Dr. Fueredi, Petitioner's expert, testified that Respondent's interpretation was below the standard of care and explained his reasons for his opinions. Dr. Foley, Respondent's expert, testified that Respondent's interpretation did not fall below the standard of care and explained his reasons for his opinions. Both of these experts are found to be highly qualified, and the testimony of each expert on this issue is found to be credible. There is no basis to credit Dr. Fueredi's testimony over that of Dr. Foley, or vice-versa. Petitioner failed to prove by clear and convincing evidence that Respondent failed to meet the standard of care in classifying P. D.'s July 1995 mammograms as BI-RADS Category 3. Petitioner also failed to establish by clear and convincing evidence that Respondent should have ordered immediate further testing for P. D. BI-RADS Category 3 suggests a short interval follow- up, without defining what constitutes a short interval. Again there was a conflict in the evidence as to whether Respondent's recommendation that P. D. be re-examined in a year fell below the standard of care. Dr. Fueredi testified that the interval for recommended follow-up should have been four to six months, and that Respondent's recommendation for a one-year follow-up fell below the standard of care. Dr. Foley testified that it was acceptable for Respondent to recommend the one-year follow- up. Both of these experts gave lengthy explanations for their opinions. Respondent's testimony as to this issue was conflicting. In his deposition testimony, Respondent testified that he intended to classify the mammogram as Category 3 BI- RADS, which meant to him that there should be a six-month follow-up. In his deposition, Respondent also testified that a recommendation for a one-year follow-up was inconsistent with a Category 3 classification. At the final hearing, Respondent testified that he was confused in his deposition, and that he intended to recommend a one-year follow-up because he knew that Dr. Kushner usually ordered mammograms for patients in P. D.'s age group every two years. This self-serving testimony given by Respondent at the final hearing lacks credibility and is rejected. Dr. Foley and Respondent (at the final hearing) did not convincingly explain how a normal follow-up interval for P. D. could also be appropriately considered to be an appropriate short interval follow-up within the meaning of BI- RADS Category 3. Respondent's deposition testimony that a recommendation for a one-year follow-up is inconsistent with a Category 3 classification is much more persuasive than his testimony on that issue at the final hearing. In resolving the conflicting testimony on this issue, the undersigned has concluded that Respondent's report contains an inconsistency which creates confusion as to the appropriate follow-up interval. The report fails to clearly reflect Respondent's examination results and recommendations for P. D.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a final order adopting the findings and conclusions contained in this Recommended Order. For the violation of Section 458.331(1)(m), Florida Statutes, it is recommended that Respondent be assessed an administrative fine in the amount of $500.00. DONE AND ENTERED this 14th day of November, 2000, in Tallahassee, Leon County, Florida. CLAUDE B. ARRINGTON 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 14th day of November, 2000.
The Issue The issue in this case is whether the license of Allen B. Erde, M.D., should be disciplined by the Florida Board of Medicine based upon actions he is alleged to have taken, or failed to have taken, between August and November, 1986, in the care and treatment of his patient, C.W.
Findings Of Fact At all times material hereto, Respondent has been licensed as a physician in the State Of Florida, having been issued license number ME-0008625. Respondent was C.W.'s obstetrician during her pregnancy in 1986, and initially examined her on August 26, 1986, when she was six weeks pregnant. During this initial visit, C.W. was informed by Respondent that her pregnancy was progressing normally. At her second visit, on September 23, 1986, Respondent detected no fetal heartbeat. However, he informed C.W. that this was not a problem. He requested that she bring her husband with her for her third visit so that they both could hear the heartbeat. Prior to her third visit, C.W. saw Respondent in his office on October 6, 1986, complaining of urinary problems, and a stiff neck and back. Respondent treated her for a urinary tract infection. Later that same day she began to bleed vaginally, passed clots and experienced cramping pains. She then saw Respondent at the Winter Haven Hospital emergency room, but was told that nothing seemed wrong. Respondent advised her simply to go home, put her feet up, and rest. There were several other occasions during October, 1986, when C.W. experienced cramping and vaginal bleeding. She called Respondent each time to express her concerns, but was told simply to lie down, and keep her feet up. On October 22, 1986, C.W. and her husband visited Respondent for her third scheduled visit. No heartbeat was heard. Respondent again told C.W. that there was no cause for concern, the baby was just small and probably behind her pelvic bone. C.W. was presumably 14 weeks pregnant at this time, but Respondent's office records indicate that the fetus was decreasing in size, there was no weight gain, and no heartone. C.W. continued to experience pain and bleeding, sometimes accompanied by clots. She was not gaining weight, and had none of the other indications of pregnancy which she had experienced in her prior pregnancies. C.W. continued to express concern to Respondent, but his advice remained simply to lie down, and keep her feet up. In response to a five day episode of bleeding, C.W. saw Respondent in his office on November 12, 1986. Although she was 17 weeks pregnant at that time, Respondent's office records indicate a fetus 14 weeks in size. Respondent did not order any fetal viability tests, and there is no evidence in his office record that he considered any testing of the fetus. C.W. saw Respondent for her fourth scheduled visit on November 19, 1986, and, again, no fetal heartbeat was detected. She was still experiencing vaginal bleeding. Her uterus was only 10-12 weeks in size, although she was presumably 19 weeks pregnant at this time. C.W. was distraught, and expressed great concern to Respondent that she was presumably almost five months pregnant and no fetal heartbeat had ever been detected. C.W. demanded that Respondent do something. He then ordered a quantitative Beta-subunit Human Chorionic Gonadotropin blood test to determine her hormone level. On November 2l, 1986, Respondent called C.W. at her place of employment, and informed her that her hormone levels were extremely low, and that she might not have a viable pregnancy. He told her she should keep her next regularly scheduled appointment with him, but if she experienced any severe bleeding or cramping to call him. C.W. left work and became increasingly upset. She contacted him later on that same day for a more complete explanation of what she should expect. Respondent told her that the fetus was "reversing itself and was losing weight instead of gaining." C.W. was not informed by Respondent that the fetus was not viable, and she took his advice to mean that if she was extremely careful there was still a chance of carrying the pregnancy to term. Respondent admitted to the Petitioner's investigator, Jim Bates, that he knew the fetus was dead at this time, but he was trying to let nature take its course, and if she did not abort in two or three months, he would take the fetus. Because she was extremely upset and her friends were concerned about the advice she was receiving from the Respondent, an appointment with another obstetrician, Dr. Vincent Gatto, was made for C.W. by one of her friends. Dr. Gatto saw C.W. on or about November 21, 1986, and after examining her he immediately diagnosed her as having had a missed abortion. A sonogram confirmed this diagnosis. A dilation and curettage was performed on C.W., and subsequent pathological reports revealed remnants of an 8-week fetus. The medical records which Respondent maintained of his care and treatment of C.W. are incomplete and contain discrepancies concerning his evaluation of the patient. They do not reflect C.W.'s numerous telephone calls, or that she was increasingly upset over the course of her pregnancy. There is no delineation of a plan of treatment in these records, or any explanation of the type of treatment he was pursuing for her. There is no explanation or justification in these records of Respondent's failure to order a sonogram or test, other than the one Beta-subunit Human Chorionic Gonadotropin, for C.W., although she repeatedly reported vaginal bleeding and cramping, and there was a continuing inability to detect a fetal heartbeat. Respondent failed to carry out the correct tests on C.W., and therefore, he failed to make a correct diagnosis of missed abortion, or to treat her correctly. He allowed her to carry a dead fetus for almost two months. Retention of the products of a non-viable pregnancy can lead to several complications, including infection, blood clotting and psychological trauma. In fact, this experience caused C.W. severe emotional anguish. In his care and treatment of C.W., Respondent failed to meet the standard of care that is required of a physician practicing under similar conditions and circumstances.
Recommendation Based upon the foregoing, it is recommended that Florida Board of Medicine enter a Final Order suspending Respondent's license to practice medicine for a period of five years, and imposing an administrative fine of $3,000. DONE AND ENTERED this 21st day of August, 1989 in Tallahassee, Florida. DONALD D. CONN Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 Filed with the Clerk of the Division of Administrative Hearings this 21st day of August, 1989. APPENDIX (DOAH CASE NO. 88-4785) Rulings on the Petitioner's Proposed Findings of Fact: Adopted in Finding l. Adopted in Finding 2. Adopted in Finding 3. Adopted in Finding 4. Adopted in Finding 5. 6-7. Adopted in Finding 6. Adopted in Finding 7. Adopted in Finding 8. Adopted in Finding 9. Adopted in Finding 10. Adopted in Finding 11. Rejected as irrelevant. 14-17. Adopted in Finding 13. 18-21. Adopted in Finding 12. 22. Adopted in Finding 14. The Respondent did not file Proposed Findings of Fact. COPIES FURNISHED: Mary B. Radkins, Esquire Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, FL 32399-0792 Allen B. Erde, M.D. P. O. Box 1817 Winter Haven, FL 33883-1817 Allen B. Erde, M.D. 198 First Street, South Winter Haven, FL 33880 Dorothy Faircloth Executive Director Northwood Centre 1940 North Monroe Street Tallahassee, FL 32399-0792 Kenneth Easley, General Counsel Northwood Centre 1940 North Monroe Street Suite 60 Tallahassee, FL 32399-0729
The Issue Whether the Respondent committed the violations alleged in the Administrative Complaint December 19, 2005, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: The Department is the state agency responsible for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. See § 455.225, Fla. Stat. (2009). The Board is the entity responsible for regulating the practice of medicine in Florida and for imposing penalties on physicians found to have violated the provisions of Section 458.331(1), Florida Statutes. See § 458.331(2), Fla. Stat. (2009). At the times pertinent to this proceeding, Dr. Achong was a physician licensed by the State of Florida, having been issued license number ME38304, and his medical office was located at 690 East 49th Street, Hialeah, Florida. Dr. Achong specialized in obstetrics and gynecology, although he was not board-certified in these areas of practice. Dr. Achong has not previously been the subject of disciplinary action by the Board of Medicine, and he is not currently practicing medicine, having retired with a disability in 2006. At the times pertinent to this proceeding, Dr. Achong had hospital privileges at Hialeah Hospital and at North Shore Medical Center ("Medical Center"). Both facilities had his home telephone number and his beeper number. It was his practice to keep his beeper close to him at all times. When he was in the delivery room, it was his practice to give his beeper to the circulating nurse, who would be responsible for alerting him whenever someone tried to reach him on his beeper. The beeper he used in 2004 gave only the telephone number of the person trying to reach him, but he was able to recognize the number of Hialeah Hospital and the Medical Center. On February 12, 2004, Patient L.H. went to her gynecologist, Ramon Hechavarria, M.D., for a routine examination. Patient L.H. was, at the time, a 27-year-old who was 32 weeks' pregnant, and she had previously had one live birth. Dr. Hechavarria's examination revealed that Patient L.H.'s blood pressure was elevated, and Dr. Hechavarria admitted her to Medical Center for 24 hours for observation. On February 12, 2004, Dr. Hechavarria ordered blood and laboratory tests done in the Medical Center. The blood tests included a Disseminated Intravascular Coagulopathy ("DIC") profile and a Fibrinogen Degradation Profile ("FDP"); the results of these blood tests were normal. Patient L.H.'s hemoglobin and her platelet count were normal, and, although there was a slight trace of protein in her urine, that is considered normal. On February 13, 2004, Dr. Hechavarria discharged Patient L.H. with a diagnosis of chronic hypertension and a prescription for 250 milligram tablets of Aldomet, to be taken three times per day. Aldomet is a medication that treats hypertension by lowering the blood pressure. Patient L.H. was in good, stable condition when she was discharged on February 13, 2004. Readings from a fetal heart monitor taken during the time Patient L.H. was in the Medical Center indicated that the fetus was alive. Dr. Hechavarria considered Patient L.H.'s to be a high risk pregnancy in part because of her hypertension but also because she came in late for prenatal care, missed two appointments, and was overweight. Dr. Hechavarria left town for a vacation on February 13, 2004, and Dr. Achong was to cover his patients during his absence under an arrangement whereby Dr. Hechavarria and Dr. Achong provided coverage for each other when one or the other was out of town or otherwise unavailable to see patients. Under the arrangement, Dr. Achong was expected to go to the hospital if one of Dr. Hechavarria's patients were in labor or if a patient were to go to the emergency room complaining of vaginal bleeding or any other obstetrical or gynecological condition. Whenever coverage of patients was passing from one physician to the other, Dr. Hechavarria and Dr. Achong advised each other of any patient that was in the hospital for gynecological, obstetrical, or any other medical reason. They did not advise each other of patients that had recently been discharged from the hospital, and, therefore, Dr. Hechavarria did not discuss Patient L.H. with Dr. Achong because she had been discharged from the Medical Center before Dr. Achong began covering Dr. Hechavarria's patients. Patient L.H. presented at the Medical Center at approximately 2:00 a.m. on February 15, 2004, complaining of abdominal pains. She was seen by labor and delivery nurse Jennifer Williams, a registered nurse with 20 years' nursing experience, with 13 years' experience in the Medical Center's labor room, and with training as a mid-wife. Nurse Williams had worked with Dr. Achong at the Medical Center since 1991. Subsequent to Patient L.H.'s arrival at the Medical Center, Nurse Williams interviewed her, took her medical history, examined her, and entered the pertinent information on the Medical Center's Admission Assessment. The Admission Assessment form was dated February 15, 2004, and the time was noted as 2:45 a.m. The time written by Nurse Williams' signature on the Admission Assessment form was 3:00 a.m., and it appears that the information was obtained and entered on the form between 2:00 a.m. and 3:00 a.m. Pertinent to this matter, Nurse Williams maintained several other documents recording Patient L.H.'s condition and observations and actions taken by Nurse Williams relating to Patient L.H. Nurse Williams began maintaining a Labor Flow Record at 2:07 a.m. and she made periodic entries on the Labor Flow Record related to, among other things, Patient L.H.'s vital signs, the results of vaginal examinations and fetal monitoring, uterine activity, and pain intensity at different times during the night and morning. In addition, Nurse Williams entered on the Labor Flow Record the time and content of her communications with Dr. Achong; the first recorded contact between Dr. Achong and Nurse Williams was recorded on the Labor Flow Record as 2:30 a.m. Nurse Williams also maintained Progress Notes in which she recorded her observations of Patient L.H. and her conversations with Patient L.H. The first entry in the Progress Notes was at 2:35 a.m.2 Nurse Williams' Progress Notes reflect that, at 2:35 a.m., Patient L.H. advised Nurse Williams that she had contractions and believed she had been in labor since 6:00 p.m. the previous evening but had waited to come to the Medical Center until she was certain she was in labor. Patient L.H. also reported abdominal pain in her upper abdomen that did "not go away," and Nurse Williams observed that Patient L.H. was distressed by the pain in her abdomen. Patient L.H. also told Nurse Williams that she had no ruptured membranes or vaginal bleeding. Nurse Williams noted that she examined Patient L.H. and felt contractions but was unable to detect a fetal heart tone. Nurse Williams reported in the Admission Assessment form that Patient L.H. was having uterine contractions of moderate intensity and 60 seconds' duration, that her cervix was dilated 1-to-2 centimeters, that she had vaginal bleeding that was bright red, that her blood pressure was 159/118, which she described as "elevated," and that Patient L.H.'s abdominal pain was the "worse" pain on a pain scale ranging from 1 to 10; there is, however, no indication on the Admission Assessment form that the pain was constant. Nurse Williams also noted on the Admission Assessment form that she heard no fetal heart rate. Although the time noted on the Admission Assessment form was 2:45 a.m., it is apparent from a review of the relevant records that the information included on the Admission Assessment form was obtained by Nurse Williams over a period of time extending from the time Patient L.H. presented to her until 3:00 a.m., the time on the Admission Assessment form beside Nurse Williams' signature. Nurse Williams reported in the "Physician /CNM in/Called Report" section of the Labor Flow Record that she contacted Dr. Achong at 2:30 a.m. and conveyed to him the following information: "[P]atient arrived in ER c/o contractions since 6 pm last night & observation that no FHT [fetal heart tone] and contractions palpated." Nurse Williams telephoned Dr. Achong using his home telephone, even though his beeper number was also on file at the Medical Center. There is nothing in the report Nurse Williams gave to Dr. Achong at 2:30 a.m. that would require that he proceed to the Medical Center and examine Patient L.H., and he did not violate the standard of care by failing to do so. Because Dr. Achong did not know Patient L.H., Nurse Williams' normal procedure would have been to advise Dr. Achong of Patient L.H.'s history, including the medications she was taking, and her vital signs, including her blood pressure. No notation appears in the Labor Flow Record to confirm that she gave Dr. Achong this information during her conversation with him at 2:30 a.m., nor is there a notation in the 2:30 a.m. entry in the Labor Flow Record that Nurse Williams told Dr. Achong about the results of her examination of Patient L.H.'s cervix, Patient L.H.'s complaint of abdominal pain, or the presence of vaginal bleeding of bright red blood.3 Nurse Williams indicated in her entry in the "Physician/CNM in/Called Report" section of the Labor Flow Record that Dr. Achong ordered a "stat," or expedited, obstetrical sonogram during the 2:30 a.m. contact with Nurse Williams. The purpose of the obstetrical sonogram was to determine if the fetus was alive. Although not noted in the Labor Flow Record, the Labor and Delivery Orders form completed by Nurse Williams indicates that, at 2:30 a.m., Dr. Achong ordered a complete blood count, which is routine with a patient in labor; a DIC profile; and a Comprehensive Metabolic Panel ("CMP"). The Labor and Delivery Orders form contains standard orders for a woman in labor, but the DIC profile and the CMP tests were not included on the form but were ordered specifically by Dr. Achong. A DIC profile is used to determine if a patient has a problem with blood clotting. The DIC includes an assessment of prothrombin time and partial thromboplastin time, both of which indicate different levels at which a patient's blood is able to clot. It is important to know whether a woman in labor and delivery has a clotting problem, or coagulopathy, because of the danger of bleeding, and the classic situation in which DIC profiles are ordered is when there is fetal demise. Because Patient L.H. had the high risk factors of overweight and hypertension and because Nurse Williams could detect no fetal heart tone, Dr. Achong's order for the DIC profile was appropriate and met the standard of care. It is also appropriate to order a DIC profile when there is a concern about placental abruption, which is the separation of the placenta from the walls of the vagina. A placental abruption causes a great deal of bleeding, and can cause death when not treated, because the fetus is still in the womb and the uterus is not able to contract and constrict the large blood vessels that attach to the placenta. Although hypertension is one risk factor for placental abruption, the symptoms of placental abruption also include fetal demise, bleeding, constant pain, a decrease in hematocrit, and a number of other conditions. There is no indication in Patient L.H.'s medical records that Dr. Achong had sufficient information at 2:30 a.m. that would indicate that Patient L.H. had a possible placental abruption, and he ordered the DIC profile because of the lack of fetal heart tones.4 The CMP includes tests for kidney and liver function and for uric acid. It is used to determine if a woman has pre-eclampsia, or pregnancy-induced hypertension. Given Patient L.H.'s history of hypertension and the level of her blood pressure as reflected in the Admission Assessment form, Dr. Achong's order for the CMP was appropriate and met the standard of care in ordering the CMP. All orders for blood tests for women in labor and delivery are treated as "stat" orders and are processed ahead of all other test orders except those from the emergency room. When the situation warrants, a physician may order that the tests be performed more quickly than the usual "stat" order would require, and it would be possible to obtain blood-test results within 45 minutes. There is, however, no indication in Patient L.H.'s medical records that Dr. Achong had any information at 2:30 a.m. that might indicate that he should further expedite Patient L.H.'s blood tests. Nurse Williams reported in her Progress Notes that, at 2:40 a.m., Patient L.H. reported a "gush of something down there," and Nurse Williams noted that she observed a large amount of blood; there is, however, no notation in the Progress Notes regarding the color of the blood. Nurse Williams also included a notation in the Progress Notes that Patient L.H.'s cervix was "3cm dilated, 50% effaced, -3 station" to describe the progress of Patient L.H.'s labor. Nurse Williams reported in the Labor Flow Record that she contacted Dr. Achong at 2:45 a.m. and conveyed to him the following information: "Dr. Achong notified of gush of vaginal bleeding. VE [vaginal examination] 2-3, 50% effaced, -3 station and that we are awaiting sonogram." The results of Nurse Williams' vaginal examination of Patient L.H. showed that Patient L.H. was in active labor. The information that Patient L.H. experienced a "gush of vaginal bleeding" did not indicate to Dr. Achong that there was anything more than one episode of bleeding, which he attributed to an especially heavy "bloody show," which is the bleeding that occurs when the cervix is dilating. The notation indicates that Dr. Achong told Nurse Williams to call him if Patient L.H. went to delivery. The information conveyed to Dr. Achong at 2:45 a.m., as reflected in the notation in the Labor Flow Record, was not sufficient to indicate that Patient L.H. was not proceeding through labor normally to a vaginal delivery of the dead fetus, which is preferred over delivery by a Cesarean Section. Nurse Williams did not include in her records a notation that she advised Dr. Achong that the "gush of vaginal bleeding" consisted of a large amount of bright red blood, which would have been an indication of a possible placental abruption. Some bleeding is normal during labor, but it is usually a dark color from having been in the uterus and in a small amount or tickle, although there could be a "gush of blood" during normal labor. When Dr. Achong was advised by Nurse Williams that Patient L.H. had a "gush of blood," however, it was his responsibility to inquire into the amount of blood, the color of the blood, and the persistency of the bleeding to determine if Patient L.H. was proceeding with normal labor or if she was experiencing a hemorrhage or other abnormal condition. Nurse Williams made no entries in the Progress Notes for Patient L.H. between 2:40 a.m. and 3:40 a.m., when she reported that the ultrasound had been completed. She further noted in her Progress Notes: "Report of no fetal heart tones to Dr. Achong. Orders given." Nurse Williams additionally made a notation in the Labor Flow Record that, at 3:40 a.m., she contacted Dr. Achong and reported to him the following: "Ultrasound report No FHT's given to Dr. Achong. Orders received." Nurse Williams did not, however, indicate in her notations what orders were given. Nurse Williams contacted Dr. Achong through his home telephone number, which was normal procedure during the nighttime hours. When the sonographer, that is, the person performing the sonogram, entered Patient L.H.'s room to perform the sonogram, he noted that Patient L.H. was sitting upright in bed, was combative, and was in a lot of pain. He also noted that there was a fair amount of blood on the bed sheets. The sonographer was able to get Patient L.H. to lie on the bed, and he performed "a very short ultrasound,"5 and pulled the machine out of the room and into the hall. He powered the machine back up and read the numbers off the worksheet on the machine. He confirmed that the fetus was dead and that the placenta appeared to be balled up rather than lying smoothly against the uterine wall, as is normal. While he was writing down the information from the worksheet on the machine, Nurse Williams approached him and told him that she had Dr. Achong on the telephone. He told her that he had "a placental abruption and fetal demise."6 He then wrote up his report, left a copy for Nurse Williams, and went downstairs to process the sonogram images.7 The results of the sonogram were reported on a form headed "Obstetrical Preliminary Report," which was completed by the sonographer. A radiologist is usually present at the Medical Center during daytime hours to read sonograms, but on the off-hours, it is the practice of the sonographer to present a sonographer's impression of what was seen during the sonogram. The sonographer who performed the sonogram on Patient L.H. noted on the report that her history included obesity, hypertension, heavy vaginal bleeding, and contractions. He included the following comments in the report: "Ant/Rt [unintelligible] placenta appears to be 'balled up[.]' Suggestion of placental abruption," and, on a separate line, "NO FETAL HEART MOTION SEEN PT IS COMBATIVE." Finally, at the bottom of the report, the sonographer noted that a copy of the report was given to Nurse Williams. There was no notation as to the time the sonographer gave the report to Nurse Williams, but, even if she had the report, she did not read it to Dr. Achong; rather, she put the copy of the report in Patient L.H.'s chart for Dr. Achong to review when he came to the hospital and gave him only a verbal report. Nurse Williams did not tell Dr. Achong during the 3:40 a.m. telephone conversation that the sonographer had reported a possible placental abruption.8 Dr. Achong was familiar with and had treated placental abruptions prior to February 15, 2004, and he always treated patients with placental abruptions on an emergency basis because both the mother and the baby could die if treatment was not received as soon as possible. Had Nurse Williams advised Dr. Achong that the sonographer had told her that he found a placental abruption or that the sonogram report included a reference to a possible placental abruption, he would have gone to the Medical Center immediately. At 3:45 a.m., Nurse Williams noted in her Progress Notes that she gave Patient L.H. Nubain and Phenergan for her painful contractions. There is no mention of continued vaginal bleeding in this entry in the Progress Notes. At 4:15 a.m., Nurse Williams noted in her progress notes that Patient L.H. was sleeping quietly and was relaxed and that Pitocin had been administered in accordance with Dr. Achong's orders. Pitocin is used to induce labor, augment labor, or to stop bleeding. In this case, Dr. Achong ordered the Pitocin to regulate Patient L.H.'s contractions. There is no mention in the 4:15 a.m. entry in the Progress Notes of continued vaginal bleeding. The next entry in Nurse Williams' Progress Notes was made at 5:15 a.m., when Nurse Williams reported that she had observed vaginal bleeding, that a vaginal examination showed dilation of four centimeters, and that Patient L.H. was very restless and moving around the bed. Nurse Williams received the laboratory report showing the results of the blood tests ordered by Dr. Achong at or around 5:00 a.m. According to the laboratory report, the blood for these tests was drawn at or about 3:20 a.m.; the report did not show any critical values in the blood sample. Nurse Williams attempted to contact Dr. Achong to convey these results to him. She noted on the Labor Flow Record that, at 5:15 a.m. "Dr. Achong beeped re lab results. Phone message left on home phone to call LR [Labor Room]." Nurse Williams made another entry on the Labor Flow Record that, at 6:55 a.m., she left a "message to Dr. Achong answering machine at home re labor progress update and labs." Dr. Achong was not, however, at home to receive the telephone calls or the messages. At or about 5:00 a.m. on February 15, 2004, Dr. Achong received a telephone call on his home telephone from Hialeah Hospital advising him that one of his patients or one of Dr. Hechavarria's patients was in active labor and about to deliver. Shortly after receiving the telephone call, Dr. Achong left his home to travel to Hialeah Hospital. He carried his beeper with him, but he did not receive any calls on the beeper. When he arrived at Hialeah Hospital and prepared to go into the delivery room, he gave it to the circulating nurse in case he should receive a beeper call while he was in the delivery room. Nurse Hayes, who had replaced Nurse Williams when Nurse Williams' shift had ended at 7:00 a.m., made a notation on the Labor Flow Record that, at 7:15 a.m., she called Dr. Achong and left a message. At 7:25 a.m., while he was in the delivery room, Nurse Hayes called his beeper. The circulating nurse had his beeper, and she notified him that he had received a call and told him the number. He recognized the number of the Medical Center, and he told the nurse to call the Medical Center and let them know that he was in the delivery room at Hialeah Hospital. Nurse Hayes asked that he call back as soon as possible. Blood for additional blood tests was drawn at or about 7:30 a.m., and the results, which were available within 15 minutes, showed several critical values that indicated that Patient L.H. was entering coagulopathy. At 7:38 a.m., as soon as he finished the delivery, he called the Medical Center and spoke with Nurse Hayes, who gave him a report on the status of Patient L.H. She told him that Patient L.H. had heavy bleeding and that the vaginal examination showed no change in the cervix. Dr. Achong ordered the Pitocin turned off. When Dr. Achong arrived at the Medical Center at 7:56 a.m., he found Patient L.H. very combative, bleeding, and with very bad vital signs. He ordered a "stat" Cesarean Section and ordered a blood transfusion. Patient L.H. died at 8:38 a.m., before any of the measures ordered by Dr. Achong could be implemented. The cause of death was recorded as placental abruption. Summary In summary, the evidence presented by the Department is not of sufficient weight to establish that Nurse Williams conveyed to Dr. Achong the information necessary for him to conclude that he should personally conduct a clinical evaluation of Patient L.H.; that he should consider the possibility that Patient L.H. had placental abruption; or that he should have provided medical assistance to Patient L.H. prior to his contact with Nurse Hayes at 7:38 a.m. Nurse Williams' Progress Notes report only two remarkable items: There were no fetal heart tones detected by physical examination or by sonogram; and, at 2:40 a.m., Patient L.H. reported a "gush of something" and Nurse Williams observed a large amount of blood. Neither Nurse Williams' entries in the Labor Flow Record regarding her contacts with Dr. Achong nor her testimony, to the extent that it has been found persuasive, is sufficient to establish that she advised Dr. Achong that she had observed a large amount of red blood at 2:40 a.m. or that the sonographer detected a possible placental abruption in the sonogram. Finally, Nurse Williams did not follow the protocol that required her to contact Dr. Achong through his beeper when she did not get an answer on his home telephone; she tried his beeper only once, at 5:15 a.m., and when she failed to reach him, left three messages on his home telephone. The Department presented no evidence to establish that Nurse Williams attempted to reach Dr. Achong by beeper between 5:15 a.m. and 7:55 a.m., the time of her last call to Dr. Achong's home telephone. Furthermore, the Department did not present evidence of sufficient weight to establish that Dr. Achong failed to initiate the appropriate procedures after he arrived at the Medical Center and examined Patient L.H. at or around 8:00 a.m. The evidence presented by the Department is, however, of sufficient weight to establish that Dr. Achong should have questioned Nurse Williams further when she advised him at 2:45 a.m. that she had observed a "gush" of vaginal bleeding. Even though vaginal bleeding may not be not unusual during labor, a report of a "gush" of blood should have alerted Dr. Achong to a potential problem. Although a physician practicing obstetrics is meeting the standard of care when relying on labor room nurses to advise him or her of the clinical status of labor and delivery patients and of any unusual symptoms exhibited by the patients, it is also incumbent on the physician to inquire further if a patient is presenting unusual symptoms. The persuasive evidence establishes that Dr. Achong violated the standard of care when he failed to ask Nurse Williams for additional information on Patient L.H.'s status during their 2:45 a.m. telephone conversation. Had he inquired further, Dr. Achong would have been alerted to the possibility that Patient L.H. had a placental abruption and would have gone to the hospital to provide appropriate care for Patient L.H.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health, Board of Medicine, enter a final order finding that Dr. Achong violated Section 458.331(1)(t), Florida Statutes, by failing to elicit further information from Nurse Williams regarding the gush of blood she observed in Patient L.H and imposing the following penalties: Issuance of a letter of reprimand; Imposition of administrative fine in the amount of $2,500.00; and Six months' probation under such conditions as the Board of Medicine determines appropriate, should Dr. Achong ever resume the practice of medicine. DONE AND ENTERED this 4th day of January, 2010, in Tallahassee, Leon County, Florida. PATRICIA M. HART 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 4th day of January, 2010.
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 Whether Respondent engaged in medical malpractice, failed to keep legible medical records, exploited a patient for financial gain, or accepted or performed the professional responsibilities of an oncologist that he knew, or had reason to know, he was not competent to perform; and if so, what is the appropriate sanction.
Findings Of Fact Petitioner is responsible for the investigation and prosecution of complaints against medical doctors licensed in the state of Florida who are accused of violating chapters 456 and 458, Florida Statutes. Respondent is licensed as a medical doctor in the state of Florida, having been issued license number ME 80412. At all times material to this proceeding, Respondent was the sole owner and sole physician at Holistic Family Medicine (HFM), a medical practice located at 9325 Glades Road, Suite 104, Boca Raton, Florida 33434. The charges against Respondent arise from Respondent's treatment of patient S.S. (S.S.) from March 17, 2011, until her death on February 10, 2013. M.S., S.S.'s mother, was present during all of S.S.'s medical appointments and was involved in all of S.S.'s medical decisions. Facts Related to S.S.'s Medical History In the spring of 2011, S.S., a 23-year-old female archeology student from Loxahatchee, Florida, suffered from a multitude of medical issues. At that time, S.S. was frustrated with her current primary care physician (PCP), Robert Federman, M.D., and treating sub-specialists because she felt that they were ignoring what she identified as her most pressing symptom, an excruciating pain in her side. Due to her frustration, S.S. sought a second opinion from Respondent at HFM on March 17, 2011. M.S. learned about Respondent from an employee at Whole Foods grocery store.2/ During her first appointment at HFM, S.S. told Respondent she was recently diagnosed with peripheral t-cell lymphoma (PTCL) by the University of Miami (UM), but that she was waiting on a second opinion from the H. Lee Moffitt Cancer Center & Research Institute (Moffitt). S.S. expressed skepticism at the PTCL diagnosis. Approximately nine months before S.S. first presented to Respondent, she suffered from unrelenting diarrhea, nausea, and vomiting. In September 2010, Dr. Federman referred S.S. to a gastroenterologist to diagnose these complaints. The gastroenterologist's attempt to diagnose S.S.'s persistent diarrhea, nausea, and vomiting eventually led to the discovery of several abnormal masses in S.S.'s abdomen. This discovery initiated a flurry of radiographic studies and biopsies that ultimately revealed cancerous cells in S.S.'s lymph nodes, consistent with PTCL. S.S. was provisionally diagnosed with PTCL by Deborah Glick, M.D., a UM hematologist during a consultation appointment on February 3, 2011. During the appointment, Dr. Glick indicated to S.S. that PTCL is a very aggressive cancer and that S.S. would likely die in a matter of months. S.S. did not agree with Dr. Glick's prognosis, so she decided to see another oncologist/hematologist. S.S. presented to Abraham Schwarzberg, M.D., a new oncologist/hematologist on February 8, 2011, to continue her ongoing work-up and management of her PTCL.3/ On February 16, 2011, after discussing S.S.'s biopsy results with UM pathology specialists, Dr. Schwarzberg recommended S.S.'s slides be reviewed at Moffitt because her case "ha[d] been a very complicated and tough case to make a diagnosis on." On February 25, 2011, S.S. traveled across the state for an oncology consultation at Moffitt, located in Tampa, Florida. Dr. Lubomir Sokol, M.D., an oncologist/hematologist employed by Moffitt advised S.S. that the long-term prognosis of PTCL patients treated with standard chemotherapy is not satisfactory. However, Dr. Sokol suggested that S.S. did not have PTCL, given the aggressive nature of the disease and her lack of symptoms at that time. Dr. Sokol requested S.S. submit her biopsy slides for review by Moffitt's pathologists, as well as by a world-renowned hemapathology expert specializing in lymphoma at the National Institutes of Health/National Cancer Institute (NCI), Dr. Elaine Jaffe. Dr. Sokol also requested S.S. undergo extensive staging exams. These exams, including a bone marrow biopsy, were negative--indicating that S.S.'s disease had not yet progressed to her bone marrow. Initial Meeting with Respondent – March 17, 2011 Of the foregoing information provided to Respondent by M.S. and S.S. during the March 17, 2011, initial appointment, Respondent only documented that S.S.'s bone marrow biopsy was negative; a seemingly insignificant detail compared to S.S.'s pending diagnosis of cancer and dire prognosis.4/ By the time S.S. spoke to Respondent on March 17, 2011, she had been told by various physicians that her biopsies were inconclusive, negative for cancer, and positive for cancer. S.S. was also told that she had PTCL and that she may not have PTCL. Finally, S.S. was told that she may die as a result of her malignancy in a matter of months. Any skepticism or doubt harbored by S.S. was completely understandable. Respondent encouraged S.S.'s skepticism by indicating to her that cancer was "low on his list" of S.S.'s possible concerns. Respondent shared a story regarding his uncle, a medical doctor who was successfully sued for $8.1 million for erroneously providing chemotherapy to a patient who did not have cancer. Respondent recommended S.S. undergo additional blood work ordered by him, so that he could have a better understanding of what was going on. Before her next appointment with Respondent, S.S.'s abdominal pain intensified, such that she presented to the Emergency Room and was admitted to Palms West Hospital (PWH) on March 28, 2011. S.S. underwent a CT scan that revealed a distended gallbladder, as well as masses in her abdomen near her liver and pancreas.5/ Ultimately, S.S.'s excruciating abdominal pain was attributed to a diseased gallbladder that needed to be immediately surgically removed. When Respondent learned of S.S.'s upcoming surgery, he told M.S. that he would get S.S.'s operative report and see S.S. in follow-up after her surgery. S.S.'s gallbladder was removed on April 1, 2011, and she was discharged with instructions to follow up with her PCP. After the surgery, S.S.'s frustration with Dr. Federman peaked, which prompted her to terminate her doctor-patient relationship with him. Although no formal notice was sent to Dr. Federman from S.S., Dr. Federman was informed by M.S. that she and S.S. were "going a different way" for her treatment. S.S. never made another appointment with Dr. Federman. Conversely, S.S. fortified her trust in Respondent and relied nearly exclusively on him for all of her future medical advice, recommendations, referrals, guidance, and treatment. Post-Surgery Follow Up with Respondent - April 7, 2011 Accordingly, on April 7, 2011, S.S. presented to Respondent for a "post-op" follow-up visit, at which Respondent discussed S.S.'s recent blood work results with her. Notably, Respondent failed to document anything concerning her post-op follow-up, aside from the paltry comment "gallbladder surgery." That same day, after S.S. left HFM, Dr. Sokol, from Moffitt, called M.S. and indicated that S.S.'s diagnosis was changed from PTCL to Hodgkin's lymphoma (HL). HL is a much less aggressive form of cancer and has a very high potential to be cured when treated. M.S. immediately updated Respondent about S.S.'s new diagnosis. Respondent indicated that he was "underwhelmed at the possibility of HL," but Respondent nevertheless assumed his role as S.S.'s PCP and attempted to coordinate care with Dr. Sokol. Request for Referral to Mayo – May 16, 2011 Because S.S. had now been presented with two conflicting diagnoses (PTCL and HL), S.S. researched cancer centers in Florida and decided to obtain a third opinion6/ from the Mayo Clinic (Mayo) in Jacksonville, Florida. On May 16, 2011, M.S. informed Respondent that S.S. made an appointment herself for a consultation at Mayo on June 1, 2011. M.S. requested that Respondent send a letter to Mayo, so he could be listed as a doctor that Mayo could contact regarding S.S.'s progress. Respondent wrote "refer to Mayo" on a prescription pad and mailed it the same day. Request for PET Scan – June 2011 On June 1, 2011, S.S. presented to Vivek Roy, M.D., an oncologist/hematologist at Mayo for consultation. Dr. Roy told S.S. that the Mayo pathologists would review her biopsy slides since there was a debate about the exact diagnosis. Dr. Roy asked S.S. to obtain an updated PET scan.7/ On June 14, 2011, Respondent again assumed his role as S.S.'s PCP by attempting to facilitate an updated PET scan for Dr. Roy. On June 20, 2011, Respondent received the PET scan report indicating that S.S.'s malignancy progressed to her pelvic region. As of this date, Respondent clearly knew S.S. was suffering from some form of lymphoma. On June 22, 2011, Dr. Roy confirmed the HL diagnosis and recommended S.S. receive ABVD chemotherapy.8/ S.S. elected to receive treatment locally and scheduled an appointment with Neal Rothschild, M.D., an oncologist/hematologist located in Palm Beach Gardens, Florida. S.S. presented to Dr. Rothschild on June 27, 2011, to discuss chemotherapy and the ongoing management of her HL. Respondent's Attribution of S.S.'s symptoms to Mold – June 2011 A few days before S.S.'s appointment with Dr. Rothschild, M.S. asked Respondent if it were possible that a "toxic something" was causing all of S.S.'s symptoms, including her swollen lymph nodes. Instead of telling M.S. that S.S.'s symptoms, including her swollen lymph nodes, were more likely caused by her untreated cancer, Respondent suggested that S.S.'s house be tested for mold. On July 5, 2011, S.S. presented to Respondent for a "check-up" and to discuss the little bit of mold that was found in her home. During the appointment, S.S. mentioned to Respondent that she met with Dr. Rothschild to discuss chemotherapy for her HL. Respondent reiterated to S.S. that cancer was "low on his list" of possible medical concerns. Respondent indicated that S.S.'s tests showing she had increased lymphocytes9/ were not indicative of cancer, especially since he did not see any "Reed- Sternberg" cells.10/ Respondent insinuated that oncologists often overreact to the presence of lymphocytes and recommend chemotherapy before making an actual diagnosis. Respondent further insinuated that Dr. Rothschild may not be a competent oncologist. Respondent recommended S.S. pursue her "mold allergy" issues and referred her to Daniel Tucker, M.D., a local allergist. Respondent also provided S.S. with a letter addressed to Dr. Rothschild wherein he emphasized that "mold could be causing all of [S.S.'s] symptoms and exam findings." As instructed, S.S. presented to Dr. Tucker on July 12, 2011, and continued to follow-up with him until November 2011. Dr. Tucker diagnosed S.S. with mold allergies and recommended a series of life-style modifications to reduce her mold allergy symptoms. Discontinuation of Oncologist/Hematologist Care – July 2011 S.S. believed Respondent's assessment that her symptoms were actually caused by allergies. Accordingly, S.S. only pursued treatment for her allergies, with the understanding that Respondent would refer her to a new oncologist/hematologist of his choosing if he thought she needed to pursue cancer treatment. On July 28, 2011, S.S. cancelled her follow-up appointment with Dr. Rothschild. M.S. indicated to Dr. Rothschild that S.S. wanted to resolve her "mold issues" before pursuing chemotherapy treatment. S.S. never returned to Dr. Rothschild or any other oncologist/hematologist for treatment. Instead, S.S. stayed under the care of Respondent, who spent the next year and a-half attempting to find the "cause" of S.S.'s symptomatic complaints. In contrast to Respondent's previous concern over S.S.'s "scary" HL diagnosis and his alleged multiple attempts to interact and coordinate care with S.S.'s oncologists, after July 5, 2011, Respondent never discussed HL, lymphoma, cancer, oncologists, or chemotherapy with S.S. again.11/ While addressing her symptomatic complaints, Respondent never told S.S. that her symptoms could be caused by untreated HL, even when many of her symptoms were reasonably attributed to her progressive HL. Complaints of Back Pain – August 2011 On August 30, 2011, S.S. complained to Respondent about "back pain." Respondent diagnosed S.S. with lumbosacral neuritis12/ and prescribed Flector patches to treat the pain. Respondent assumed S.S.'s back pain was caused by mold without ever conducting an appropriate evaluation, including physical examination, or test to determine its cause. S.S. was charged $200.00 for the August 30, 2011, office visit. Complaints of Lymph Node Swelling – December 2011 On December 15, 2011, S.S. complained to Respondent about her lymph nodes and swelling. Respondent did not address S.S.'s lymph node or swelling concerns. Respondent failed to conduct and document a complete and appropriate physical exam of S.S.'s lymph nodes. S.S. was charged $425.00 for the December 15, 2011, visit. Concern Regarding Lymph Nodes, Pain, and Dysuria – March 2012 On March 5, 2012, S.S. complained to Respondent about pain in her side, pain in her lymph nodes resulting in sleeping trouble, urgency, and dysuria.13/ Respondent treated S.S.'s painful lymph nodes with low-dose naltrexone. Respondent assumed S.S.'s symptoms of urgency and dysuria were caused by a urinary tract infection (UTI) and prescribed antibiotics to treat the "UTI." UTIs are diagnosed with a urine culture or urinalysis. These tests are also useful in determining the strain of bacteria, which would dictate the most appropriate type of antibiotic to use. Respondent did not perform a urine culture or urinalysis before prescribing an antibiotic to treat S.S.'s UTI-like symptoms. Respondent did not perform and document a complete and accurate physical exam of S.S.'s lymph node swelling, noting where the swollen lymph nodes were located or any other appropriate documentation of the exam. S.S. was charged $205.00 for the March 5, 2012, appointment. Complaints of UTI-like Symptoms – May 2012 through January 2013 S.S. repeatedly complained to Respondent about UTI-like symptoms, including on May 3, 2012, May 10, 2012, May 16, 2012, June 27, 2012, and January 3, 2013. Each time, Respondent assumed S.S.'s symptoms were caused by a UTI and prescribed her antibiotics without ever performing a urine culture or urinalysis to confirm the diagnosis or determine which antibiotic would be most appropriate to prescribe. Respondent also considered that S.S.'s UTI-like symptoms may be caused by an uncommon antibiotic-resistant infection called interstitial cystitis. Continued Concerns Regarding Lymph Nodes – May 16, 2012 On May 16, 2012, S.S. presented to Respondent with complaints of enlarged lymph nodes. Respondent did not examine, document an examination of, or otherwise address S.S.'s enlarged lymph nodes. However, S.S. was charged $200.00 for the May 16, 2012, appointment. Swollen Legs – January 3, 2013 On January 3, 2013, S.S. complained to Respondent about swelling in her legs. Respondent assumed S.S.'s swollen legs were caused by an allergic reaction, without performing any diagnostic examination or tests to confirm his assumption. S.S. was charged $200.00 for the January 3, 2013, appointment. Abdominal Pain and Swelling – January 2013 On January 11, 2013, S.S. complained of abdominal pain and swelling. Respondent assumed S.S.'s pain and swelling were caused by an allergic reaction and prescribed an allergy medication to treat her pain and swelling. On January 12, 2013, S.S. again complained of swelling in her legs. Respondent assumed S.S.'s swollen legs were caused by an allergic reaction and prescribed her an allergy medication. On January 14, 2013, S.S. underwent blood work at Respondent's request. The blood work cost S.S. $575.00. When Respondent received S.S.'s blood work results, Respondent called S.S. in for an urgent appointment because he thought her blood work results were "striking" and really "weird."14/ Urgent Appointment – January 24, 2013 The blood work did not test S.S.'s iron levels. Regardless, Respondent felt S.S. was iron deficient and instructed his medical assistant (MA) to administer 100 mg of iron to her on January 24, 2013. S.S.'s blood work revealed that she had high calcium levels. Respondent considered that S.S.'s potential issue with her parathyroid hormone (PTH) was her "dominant concern" at that time. Respondent recommended S.S. receive more testing and suggested that she may need PTH surgery in Tampa. Respondent also determined that S.S. had issues with her DHEA, Vitamin D, and T3 levels and spent considerable time discussing these concerns. During the urgent appointment, S.S. complained of swelling in her legs accompanied by weakness. S.S.'s pain and swelling was so severe that she used a cane to assist her in walking and requested Respondent to assist her in obtaining a temporary parking permit. Respondent now assumed S.S.'s swollen legs were caused by water retention and prescribed a diuretic to treat S.S.'s swollen legs. At no time during this appointment did Respondent inquire about, or suggest, that S.S.'s symptoms were attributable to HL or its treatment. S.S. was charged $680.00 for the January 24, 2013, urgent appointment. On the same day, S.S. underwent more blood work at Respondent's request. The additional blood work cost S.S. another $355.00. Review of Blood work – February 2013 On February 5, 2013, when Respondent reviewed S.S.'s second set of blood work results, Respondent was confused by her results and indicated that he was going to review S.S.'s chart to "come up with a better idea of what is going on." Despite knowing of S.S.’s significant cancer diagnosis since June 2011, Respondent did not consider, or discuss with S.S., the possibility that S.S. had unusual results because she had cancer, or in the alternative, was undergoing chemotherapy treatment. S.S.'s blood work revealed that she had normal iron levels. Nevertheless, Respondent felt S.S. was iron deficient and instructed his MA to administer 100 mg of iron to her on February 7, 2013. S.S. was charged $150.00 for the iron shot. Patient's Death – February 10, 2013 When S.S. went to HFM for her shot, she was in significant distress related to pain and severe swelling in her legs. S.S. rapidly decompensated and died in the hospital three days later, on February 10, 2013. Respondent initially thought S.S. may have died either from an adverse reaction to the iron shot or a combination of pneumonia and sepsis causing respiratory failure. When the medical examiner who performed S.S.'s autopsy notified Respondent that S.S. died from complications of untreated HL, Respondent responded by saying that S.S. had never been definitively diagnosed with HL. Despite having reviewed S.S.'s radiographic, pathology, and oncology consultation reports indicating that S.S. had HL,15/ and having treated her symptoms indicative of progressed HL for nearly two years, Respondent refused to believe that S.S. had HL, choosing instead to believe that she presented "more like a [chronic fatigue] patient allergic to mold than a lymphoma patient." It was not until Respondent received the final autopsy report, several months after S.S. died, that Respondent was finally "satisfied" that S.S. had HL all along. Facts Related to the Standard of Care Violation Charles Powers, M.D., an expert in family medicine, offered testimony on the standard of care that a doctor providing primary care services to a patient in a family medicine practice setting is required to follow when a young patient is diagnosed with HL, a highly curable malignancy. Dr. Powers opined that the role of the PCP is to use his or her established relationship with the patient to facilitate and ensure that the patient receives appropriate treatment. In this case, Respondent's role as S.S.'s PCP was to ensure that S.S. received chemotherapy, or in the alternative, be fully informed of the consequences of foregoing chemotherapy. Stephen Silver, M.D., testified on behalf of Respondent and opined that Respondent's role in S.S.'s care was as an out-of-network, adjunct holistic doctor, more comparable to an acupuncturist or Reiki specialist than a medical doctor. Dr. Silver suggested that Respondent should not be held to the same standard as other family medicine doctors providing primary care services. Dr. Silver opined that because of Respondent's limited "adjunctive holistic" role, the standard of care in Florida did not require Respondent to be engaged in S.S.'s care and treatment with relation to her cancer. Dr. Silver based his opinion on the incorrect assumption that from March 2011 to February 2013, S.S. was under the care of her former PCP, Dr. Federman, and that Respondent provided strictly adjunctive holistic treatment to S.S.16/ Dr. Silver defined "holistic therapies" to include acupuncture, massage, nutritional therapies, vitamin therapies, and energetic medicine, such as Reiki. Dr. Silver specified that surgery and pharmaceuticals are not "holistic therapies," but instead fall in the realm of "traditional medical services." Respondent did not provide "strictly holistic" treatment to S.S. From March 2011 to February 2013, Respondent prescribed and recommended 27 substances to S.S. Of those substances, 15 of them were drugs (including legend drugs, compounded medications, and over-the-counter medications) and 12 were nutritional supplements/vitamins. Respondent also recommended that S.S. undergo surgery, was actively involved in S.S.'s post-operative care, and ordered two PET CT scans for S.S. Respondent never recommended S.S. receive massage therapy, acupuncture, or Reiki. Furthermore, it is clear that by May 2011, S.S. severed all ties from her former PCP and relied on Respondent to fulfill the role of her PCP. Therefore, Respondent was not providing strictly "adjunctive" care to S.S. Dr. Silver contends that Respondent could not have been S.S.'s PCP because he was "out-of-network" with S.S.'s insurance, did not advertise as a PCP, and had a very "holistically- oriented" medical intake form. However, a PCP is not simply defined as the doctor whose name appears on a patient's insurance card. Instead, the definition of a PCP is a fluid concept that includes the doctor whom the patient trusts to provide appropriate medical advice, guidance, recommendations, referrals, and treatment.17/ Under this definition, it is possible for even a sub-specialist to operate as a patient's PCP. Those involved in S.S.'s medical treatment, including M.S., Dr. Tucker, and Dr. Juste, believed that Respondent was S.S.'s PCP. Additionally, Respondent advertised that he offered concierge-level primary care services to his patients on his website. Respondent operated as S.S.'s PCP, regardless of whether he was out-of-network with her insurance provider, advertised as a PCP, or had a "holistic" intake form. Based on the foregoing, Dr. Silver's opinion, that Respondent is not required to adhere to the same standard of care as family medicine doctors in Florida, is rejected. Timely Referral When a PCP learns that a young patient is diagnosed with a highly curable malignancy, the standard of care in Florida requires the PCP to timely refer the patient to an oncologist/hematologist for chemotherapy treatment. This standard is applicable as long as the patient is not under the current care of an oncologist/hematologist. From July 2011 to February 2013, Respondent knew, or should have known, that S.S. was not under the care of a treating oncologist/hematologist and should have timely referred her to one, or ensured that she present to an oncologist/hematologist. Although Respondent suggested that he did refer S.S. to an oncologist, he eventually attempted to justify his failure to do so by alternatively asserting: 1) it was not his duty to refer S.S. to an oncologist; 2) it was unnecessary to refer S.S. to an oncologist because she was already under the care of an oncology "team"; and 3) it was unnecessary to refer S.S. to an oncologist because she adamantly refused to be treated for HL. At the final hearing, Respondent testified that he did not refer S.S. to an oncologist because he assumed she was under the care of Dr. Rothschild, receiving treatment as appropriate, from June 2011 until her death in February 2013. If it were true, why then would Respondent prescribe countless medications to S.S. without ever consulting her treating oncologist? Respondent himself testified that the treating oncologist needed every piece of information about the patient's concurrent treatment. Respondent's testimony in this regard simply is not credible. Respondent's testimony was also directly contradicted by his previous statements where he indicated that S.S. adamantly refused to undergo chemotherapy and that she rebuffed and resisted his attempts to encourage her to follow up with an oncologist. Respondent further contends that he went above-and- beyond his duty as a "holistic doctor" by "ensuring" S.S. went to Mayo for her consultation by writing "refer to Mayo Clinic" on a prescription pad (after S.S. already scheduled her appointment). However, Respondent never provided a definitive explanation for the purpose of this "refer to Mayo Clinic" document, and even at one point described it as a "back to school note" for S.S. to take to class. Based on these inconsistencies, Respondent's testimony regarding an oncology referral was not credible. M.S. testified that Respondent did not refer S.S. to an oncologist/hematologist, even though Respondent knew that S.S. was not under the care of one. M.S. also testified that S.S. was waiting on Respondent to refer her to an oncologist/hematologist if and when he decided that S.S. had lymphoma. M.S. testified that had Respondent referred S.S. to an oncologist/hematologist that he trusted, S.S. would have gone to that doctor for treatment. M.S.'s testimony was clear, concise, consistent, and credited. Respondent failed to timely refer S.S. to an oncologist/hematologist for appropriate treatment as soon as he knew or had reason to know that S.S. was not under the care of an oncologist/hematologist. Duty to Educate or Counsel After timely referring the patient to an oncologist/hematologist for treatment, if the doctor learns that the patient does not want to receive treatment, either because the patient is in denial of the diagnosis or simply does not want the treatment, the standard of care in Florida requires the PCP to educate or counsel the patient on the risks, including death, of foregoing potentially life-saving treatment, so that the patient can make a fully-informed decision. As the doctor counsels the patient, he or she must refrain from facilitating or encouraging the patient's denial of their diagnosis. Respondent stated that S.S. was in denial of her diagnosis of lymphoma long before she first came to see him and remained in denial of the diagnosis despite his multiple attempts to educate and counsel her. Specifically, Respondent claims he educated or counseled S.S. on May 12, 2011, May 16, 2011, March 5, 2012, May 16, 2012, and January 3, 2013. Any reference to these alleged discussions are absent from Respondent's notes. Respondent claims his advice was rebuffed, met with "stiff resistance," and that S.S. and her mother ultimately refused to believe that she had lymphoma. Respondent's statements were not credible because again, in direct contradiction to himself, Respondent testified at the final hearing that after July 5, 2011, he never spoke to S.S. about her lymphoma because he assumed S.S. was under the care of Dr. Rothschild and was receiving treatment as appropriate. In contrast, M.S. credibly testified that not only did Respondent never educate or counsel S.S. on the risks of not treating her lymphoma, he continuously undermined the recommendations and advice of the oncologists and facilitated S.S.'s skepticism toward her diagnosis. Indeed, instead of using his relationship with S.S. to assuage her fears related to her possibly life-threatening disease, Respondent expressed that he was "underwhelmed" with the possibility that she had lymphoma and repeatedly told S.S. that cancer was low on his list of possible medical concerns. Respondent further undermined the oncologists by indicating to S.S. that it would be potentially deadly to undergo chemotherapy if she did not actually have HL, despite knowing that S.S.'s confidence in her diagnosis was already very tenuous. Respondent failed to educate and counsel S.S. on the risks, including death, of failing to receive treatment for her HL. Symptoms When a patient makes a fully-informed decision to forego treatment of an otherwise terminal illness, such as HL, the standard of care in Florida requires the PCP to attribute the patient's symptoms that are reasonably caused by the malignancy to the malignancy. Additionally, the standard of care in Florida prohibits the PCP from attempting to find an alternate diagnosis for these symptoms, when the PCP knows that treatment for the alternate/secondary diagnosis would not change the patient's life expectancy. A June 20, 2011, Skull to Thigh PET CT scan of S.S. showed hypermetabolic masses and enlarged lymph nodes throughout S.S.'s body. These PET CT scan findings can only be attributed to a malignancy and are most consistent with HL. By June 2011, Respondent knew that S.S.'s HL had significantly progressed and included the involvement of her chest, abdomen, and pelvis. Respondent attributed these exam findings to S.S.'s allergies to mold, food, and drugs. As HL progresses throughout the body, it can cause the lymph nodes to enlarge. S.S. suffered from enlarged lymph nodes, a symptom reasonably attributed to HL. Respondent attributed S.S.'s enlarged lymph nodes to S.S.'s mold allergy. The enlarged lymph nodes can apply pressure on adjacent organs and structures, causing irritation and pain. S.S. suffered from back pain, a symptom that is reasonably attributed to HL. Respondent attributed S.S.'s back pain to S.S.'s mold allergy. S.S. suffered from abdominal pain, a symptom that is reasonably attributed to HL. Respondent attributed S.S.'s abdominal pain and swelling to an allergic reaction to an antibiotic, even though he had never seen this type of an allergic reaction to an antibiotic before. HL can suppress the immune system, making patients more susceptible to infections, like UTIs. HL can also mimic UTI symptoms if the lymph nodes in the patient's pelvic region are enlarged and pushing on the organs in the urinary tract. S.S. regularly experienced UTI-like symptoms like urgency and dysuria. These symptoms, whether they were caused by a UTI or from the pelvic lymph node involvement, are reasonably attributed to HL. Respondent attributed S.S.'s UTI-like symptoms to an infection without ever obtaining a urine culture or urinalysis to confirm his assumption. HL often causes swelling in patient's extremities by affecting the lymphatic system, which is used to transport fluids throughout the body. S.S. experienced extreme painful swelling in her legs, a symptom that was caused by her HL. Respondent attributed S.S.'s swollen legs to an allergic reaction. Respondent claims that he was "keenly" aware that S.S.'s symptoms could have been caused by HL and that he repeatedly informed S.S. of the same. However, Respondent claims that S.S. may have had concurrent illnesses that were causing similar symptoms and that it was not inappropriate for him to treat those symptoms. Interestingly, Respondent's notes do not reflect that he discussed with S.S. that her symptoms could be attributed to her untreated lymphoma. Despite being "keenly" aware that S.S. was suffering from untreated Stage III HL, Respondent often expressed bewilderment as to the cause of S.S.'s symptoms and repeatedly remarked that he wanted to "find out what was going on" and ordered blood work purportedly for that purpose. Due to the inconsistencies, Respondent's testimony is not credible. M.S. credibly testified that Respondent never indicated that any of these symptoms were likely caused by HL and that he spent time with S.S. trying to find the real cause of her symptoms. Respondent completely ignored S.S.'s existing HL diagnosis and instead believed that S.S. presented "more like a CFIDS[18/] patient allergic to mold than a lymphoma patient." Respondent failed to appropriately attribute S.S.’s symptoms to HL. Facts Related to Medical Records Violation During each office visit, Respondent should have created a progress note that included the subjective complaints of the patient, the objective observations of the patient (including a physical exam), an assessment of the patient's medical concerns, and a treatment plan (commonly referred to as "SOAP notes"). Included in these notes should be adequate justification for each diagnosis given and prescription given to the patient. Respondent failed to create or keep documentation of an adequate medical justification for the diagnoses he made and the treatment he provided to S.S. 134. On April 7, 2011, July 5, 2011, August 30, 2011, December 15, 2011, March 5, 2012, January 3, 2013, and January 24, 2013, Respondent failed completely to document the objective portion of the exam. Respondent also routinely failed to document adequate medical justification for the diagnoses or treatments rendered to S.S. Respondent failed to create or keep documentation in which he purportedly referred S.S. to an oncologist. Similarly, Respondent failed to create or keep documentation of his alleged educating or counseling of S.S. on the risks of foregoing chemotherapy treatment. Facts Related to Scope of Practice Respondent testified that he did not practice outside of the scope of his profession or perform or offer to perform professional responsibilities that he knows he is not competent to practice because he did not treat S.S. for cancer and did not offer to treat her for cancer. Petitioner offered the testimony of Roy Ambinder, M.D., an expert in oncology and hematology. Dr. Ambinder testified regarding the scope of practice for an oncologist and the standard of care for oncologists treating HL. Dr. Ambinder's testimony was clear, concise, consistent, and credited. It is not within the scope of practice for a family medicine physician to modify or reject an existing diagnosis of HL. Oncology is the study of cancer. A physician needs oncology training, experience, and a background in oncology to modify or reject an existing diagnosis of HL. Before modifying or rejecting an existing diagnosis of HL, a physician with the appropriate training, experience, and background would have to perform a physical exam, obtain blood work and additional radiographic studies, review past reports from the pathologists/oncologists, and review and interpret tissue biopsies. Respondent knew that five oncologists/hematologists, including specialists from Moffitt, NIH, and Mayo diagnosed S.S. with lymphoma. Respondent knew that he did not have the necessary qualifications, skill, training, education, or experience to modify or reject a diagnosis of HL. Yet, after harboring significant skepticism towards the diagnosis, Respondent reviewed S.S.'s pathology reports and radiographic studies and rejected S.S.'s HL diagnosis. Therefore, Respondent acted in the role of an oncologist, regardless of whether he actually treated, offered to treat, or advertised that he could treat S.S. for cancer. Respondent acted beyond the scope of his practice by law and performed professional responsibilities that he knew he was not competent to perform by rejecting S.S.'s existing diagnosis of HL. Facts Related to Financial Exploitation Violation Respondent knew, or should have known, that S.S. had lymphoma. Respondent knew that the only approved effective treatment for HL is chemotherapy and that if left untreated, HL will cause a patient's untimely death. Despite knowing that S.S. had HL, Respondent tried to find an alternate diagnosis to explain S.S.'s symptoms. M.S. and S.S. trusted Respondent to make medical decisions in S.S.'s best interest, such that Respondent was able to convince M.S. and S.S. that S.S.'s symptoms were caused by something other than HL, thus necessitating additional appointments and blood work. Between August 30, 2011, and February 7, 2013, Respondent addressed S.S.'s symptoms, which were reasonably caused by HL, with a variety of symptomatic treatments that Respondent knew, or should have known, would not have affected S.S.'s HL or extended her life expectancy. Respondent's MA administered S.S. $300.00 worth of InFed injections when he knew, or should have known, that S.S. was not iron-deficient and that iron would not have addressed S.S.'s fatal illness. Even if S.S. was iron-deficient, iron supplements would not have extended S.S.'s life expectancy. Respondent ordered $930.00 worth of blood work testing for S.S. when he knew or should have known that additional blood work would not have affected the established diagnosis of HL and that any diagnosis derived from the lab results would not have extended S.S.'s life expectancy. Respondent charged S.S. $1,760.00 in appointment fees over a one and a-half year period. During these appointments, Respondent treated S.S.'s symptomatic complaints with treatments that Respondent knew, or should have known, would not have addressed S.S.'s HL. Moreover, even if the treatments appropriately addressed a secondary diagnosis, Respondent knew, or should have known, that these consultations and recommended treatments would not have extended S.S.'s life expectancy. Accordingly, S.S. and her family paid Respondent and HFM approximately $2,990.00, in pursuit of treatment that Respondent influenced them to believe was necessary, appropriate, and would lead to or improve S.S.'s health. Respondent benefitted financially from the payments remitted to him and HFM by S.S. Facts Related to Aggravating Factors Respondent's conduct resulted in significant harm, including the extended suffering and ultimate death, of patient S.S. Petitioner entered a Final Order against Respondent's license in DOH Case No. 2008-00890 for violations of Sections 458.331(1)(t), and 458.331(1)(m), Florida Statutes (2003-2004). The Final Order constitutes discipline against Respondent's license.19/
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding that Respondent violated sections 458.331(1)(t), 458.331(1)(m), 458.331(1)(n), and 456.072(1)(o), Florida Statutes, as charged in Petitioner's Second Amended Administrative Complaint; imposing a fine of $16,000.00; requiring repayment of $2,990.00 to the estate of S.S.; revoking Respondent's license to practice medicine; and imposing costs of the investigation and prosecution of this case. The undersigned reserves jurisdiction to rule on Daniel Tucker’s Application and Motion for Award of Expert Witness Fees. DONE AND ENTERED this 29th day of April, 2016, in Tallahassee, Leon County, Florida. S MARY LI CREASY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 29th day of April, 2016.
The Issue Whether disciplinary action should be taken against Respondent's license to practice as a physician, license number ME 0060427, based on violations of Sections 458.331(1)(j) Florida Statutes, by exercising influence within a patient-physician relationship for purposes of engaging a patient in sexual activity and Section 458.331(1)(x), Florida Statutes, by violating any provision of this Chapter, in that he violated Section 458.329, Florida Statutes, and Rule 59R-9.008, Florida Administrative Code, by committing sexual misconduct in the practice of medicine.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that Respondent be found guilty of violating Sections 458.331(1)(j) and (x), Florida Statutes as to Patients T.S. and A.A. As discipline therefore, it is FURTHER RECOMMENDED: Respondent's license be suspended for a period of one year, commencing December 12, 1994, with his reinstatement upon demonstration that he can practice with skill and safety and upon such conditions as the Board of Medicine shall deem just and proper. Respondent pay an Administrative fine in the amount of $6,000.00. Respondent be placed on probation for a period of three years. DONE and ENTERED this 9th day of May, 1995, in Tallahassee, Florida. DANIEL M. KILBRIDE 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 9th day of May, 1995. APPENDIX The following constitutes my specific rulings, in accordance with section 120.59, Florida Statutes, on proposed findings of fact submitted by the parties. Proposed findings of fact submitted by Petitioner. Accepted in substance: paragraphs 1, 2, 3, 4, 5, 6, 8, 9 (in part), 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 29 (in part), 30, 3, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 49, 50, 51, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88. Rejected as subsumed or irrelevant and immaterial: paragraphs 7, 9 (in part), 17 (in part), 28, 29 (in part), 59, 61, 65. Rejected as not proven by clear and convincing evidence: paragraphs 52, 53, 54, 55, 56, 57, 58, 60, 62, 63, 64, 66, 67. Proposed findings of fact submitted by Respondent. Accepted in substance: paragraphs 1, 2, 3, 4, 5, 6, (in part), 7, 8, (in part), 9, 10 (in part), 12, 18 (in part), 19 (in part), 20 (in part), 21 (in part), 22 (in part) 27 (in part), 31, 44 (in part), 46 (in part), 47 (in part), 48 (in part), 49 (in part), 53 (in part), 57 (in part), 58 (in part). Rejected as subsumed or irrelevant and immaterial: paragraphs 6 (in part), 8 (in part), 10 (in part), 13, 15, 16, 18 (in part), 20 (in part), 21 (in part), 23, 24, 25, 26, 28, 29, 30 (in part), 34, 35, 36, 38, 39, 43, 44 (in part), 50, 55, 57 (in part), 58 (in part). Rejected as a restatement or commentary on the evidence: paragraphs 11, 14, 17, 22 (in part), 23, 27 (in part), 29, 30, 34, 35, 36, 37, 48, 40, 41, 42, 44 (in part), 45, 46 (in part), 47 (in part), 48 (in part), 49 (in part), 50, 51, 52, 53 (in part), 54, 55, 56. Rejected as not supported by the evidence: 19 (in part), 20 (in part), 32 and 33. COPIES FURNISHED: William Frederick Whitson, Esquire Senior Attorney Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0792 Lee Sims Kniskern, Esquire 2121 Ponce de Leon Blvd. Suite 630 Coral Gables, Florida 33134 Dr. Marm Harris Executive Director Department of Business and Professional Regulation 1940 North Monore Street Tallahassee, Florida 32399-0792 Tom Wallace Assistant Director Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303
The Issue The issues are whether Respondent deviated from the applicable standard of care, failed to keep medical records justifying the course of treatment, improperly delegated professional responsibilities, or prescribed, dispensed or administered controlled substances other than in the course of his professional practice; and, if so, what penalty should be imposed.
Findings Of Fact Respondent is a licensed physician in Florida, holding license number 59702. He has been licensed in Florida since 1991. Respondent is Board-certified in obstetrics and gynecology. His last certification was in November 2009. Respondent received his bachelor of science degree from the University of North Carolina at Chapel Hill in 1978. He received his doctor of medicine degree from Meharry Medical College in Nashville in 1982. He performed a surgical internship from 1982-83 with the Madigan Army Medical Center in Tacoma, an obstetrics and gynecology residency from 1987-91 at the Harbor Hospital Center in Baltimore, and a maternal fetal medicine fellowship from 1991-93 at the University of South Florida. During the residency, Respondent completed a six-week rotation in the mental evaluation, diagnosis, and treatment of transgendered patients. The training took place on the campus of Johns Hopkins University, which was one of the first medical schools to offer training in the diagnosis and treatment of transgendered patients. During this rotation, Respondent assumed responsibility for the care of about 30 patients, a little over half transitioning from female to male. From 1991-93, Respondent performed obstetrics and gynecology at several medical facilities in Florida, Maine, and Missouri. From 1993-96, Respondent was the Chief of Perinatology, Healthy Start Program, at the D.C. General Hospital/Howard University in Washington. In 1996, Respondent started the Orlando Women's Center (OWC) in Orlando, which he still owns and operates. He opened a second women's clinic in Orlando the following year. Respondent also participated in the starting of women's clinics in Ocala in 1998, Fort Lauderdale in April 1999, and Tampa in October 1999. In October 1996, about six months after opening, OWC hired M. W. as a medical assistant. She had nearly completed the coursework to become a licensed practical nurse, but at no time material to this case was she ever a licensed health care provider. M. W. was employed by OWC until 1999. M. W. was a diligent employee. Her initial duties were answering the telephone and working in the lab. However, her enthusiasm, intelligence, dedication, and discretion earned M. W. a promotion. In January 1997, Respondent promoted M. W. to a trusted position in which she would care for patients undergoing abortions during the second trimester of pregnancy. Working conditions required M. W. to be on-call nearly all of the time, as certain patients demanded to be admitted during nights or weekends to preserve confidentiality. The work was stressful because some patients bore fetuses with abnormalities, and protestors regularly demonstrated outside the clinic. M. W.'s new duties allowed Respondent himself to observe her work and determine that M. W. had the psychological stability to perform her job well. M. W. demonstrated her trustworthiness by dealing with patients' valuables, opening and closing the clinic, ordering supplies and stocking five surgical rooms, and drawing controlled substances for administration by Respondent. At the end of 1997, Respondent promoted M. W. to ordering and stocking the clinic's medical supplies, which include controlled substances. For Schedule II drugs, which includes narcotics, and Schedule III drugs, which includes steroids, M. W. had to fill out a DEA Form 222, using Respondent's DEA number to place the order. When OWC received Schedule III drugs, M. W. matched the order with the shipment. She then recorded the information in the OWC drug log. M. W. would place the drugs in a locked cabinet, if they were not needed for immediate use in the clinic. After nearly one year of ordering supplies, toward the end of 1998, M. W. approached Respondent to discuss a personal matter. At this point, the material disputes between the parties emerge. Respondent testified that M. W. discussed with him the possibility of undergoing transgender therapy, as well as treatment for an injured shoulder. According to Petitioner, M. W. discussed with Respondent the possibility of using anabolic steroids to improve her bodybuilding and weightlifting. The parties do not dispute that M. W. had participated in bodybuilding and weightlifting for several years prior to her employment with OWC. The Administrative Law Judge credits Petitioner's version of the purpose of treatment. Respondent testified that M. W. told him that she had thought about changing genders for several years. She did not like or want her breasts. She did not like the shape of her hips and thighs. She had decided that she did not want children and did not want to undergo menstruation. Although M. W. may have told Respondent that she did not like her body shape, she did not tell him that she wanted to change into a man. As discussed below, M. W. is not available to confirm or deny Respondent's version of events, and Respondent does not have any medical records documenting his care and treatment of M. W. Assigning a secondary reason for the treatment--healing a long-injured shoulder--is an awkward fit with Respondent's version of events, given the unlikelihood that someone considering a decision as major as changing genders would bother assigning a secondary reason for the decision. This secondary reason for the treatment is a better fit with Petitioner's version of events, although treatment of an injured shoulder was, at most, a very minor factor in the steroid treatment because the reconstructed medical records, discussed below, mention strength and bodybuilding, not recovery from a shoulder injury. The most important reason to credit Petitioner's version of the purpose of the steroid treatment over Respondent's version is that Petitioner's version conforms to Respondent's initial description of the purpose of the treatment. In other words, this is not a case of Respondent's word against contrary inferences drawn by Petitioner; this is a case of Respondent's later word against Respondent's earlier word. The parties do not dispute that, after the initial meeting to discuss the personal matter, Respondent agreed to allow M. W. to order anabolic steroids using his DEA number and at the discounted price charged to OWC. The drugs that Respondent expressly allowed M. W. to order--and which he prescribed for her--were Winstrol and, a short while later, depo-testosterone. Respondent prescribed for M. W. Winstrol orally at the rate of 2 mg per day, increasing to 10 mg per day at the end of six weeks, and depo-testosterone by intramuscular injection, which Respondent administered initially at the rate of 50 mg every two weeks, increasing to 200 mg every two weeks. The parties do not contest that, in early summer 2009, M. W. ordered through OWC sufficient Winstrol and Deca-Durabolin for her weightlifting father and brother, with whom she lived, to complete one six-week bodybuilding cycle each with these two anabolic steroids. For her brother, the evidence establishes that M. W. ordered through OWC additional Winstrol and sufficient depo-testosterone for him to complete a second six- week cycle. The evidence is undisputed that M. W. administered the injections of Deca-Durabolin and depo-testosterone to her brother, Deca-Durabolin to her father, and Deca-Durabolin to herself. M. W. probably took additional Winstrol at home. The evidence is also clear that, in addition to ordering the Winstrol and depo-testosterone in quantities in excess of the amount that she was authorized to order and Deca-Durabolin without any authority whatsoever, M. W. also ordered--without authorization--Xanax, an anti-anxiety drug, and Soma, a muscle relaxant, possibly for her own use. Petitioner contends that Respondent knew or reasonably should have known of these unauthorized orders, but the evidence that Respondent knew is nonexistent, and the evidence that he should have known is insubstantial. There is little, if any, dispute that, unknown to Respondent, M. W. was using cocaine and heroin--by her own admission since early 1998. In late July 1999, Respondent was informed that M. W. had passed out at work. When Respondent spoke with her about this incident, M. W. admitted to the use of cocaine and heroin, most recently a couple of weeks earlier. Respondent immediately withdrew his authorization of M. W. to order supplies and medications for OWC and immediately discontinued further steroid treatment. Acting as M. W.'s employer, not physician, Respondent ordered M. W. to submit to a drug screen for Demerol, which had been missing from OWC,2 Valium, and cocaine. Three weeks later, he received the results, which were positive for cocaine. After giving M. W. an opportunity to discontinue illegal drug use, Respondent ordered M. W. to submit to another drug screen for Demerol, Valium, fentanyl, cocaine, and heroin, and the report, received in late August, was positive for cocaine and Valium. On September 22, 1999, M. W. was found dead in her home by her father. The first law enforcement officers responding to the 911 call reported that they had found a lifeless male dressed in woman's panties; this mistaken observation was based on M. W.'s muscularization and shadowy presence of facial hair. A homicide detective conducting an initial investigation found large quantities of syringes and prescription drugs, mostly steroids, in M. W.'s bedroom. He also found shipping labels and receipts with the names of OWC and Respondent. The parties have stipulated that the death was unrelated to steroid use. M. W.'s death was classified as a natural death. She was 30 years old. In resolving the major factual dispute--i.e., the purpose of the treatment--the Administrative Law Judge has assigned considerable weight to Respondent's earlier responses to law enforcement and regulatory inquiries. In these responses, Respondent never mentioned transgender treatment or gender identity disorder, but instead admitted that the treatment was to enhance athletic performance and to facilitate bodybuilding. In a written reconstruction of the medical records done prior to the commencement of this case, Respondent stated that he was "unable to locate [M. W.'s] chart so I will reconstruct her chart from memory. Last time chart was seen was June [19]99 which was given to [her]." The reconstructed chart shows three office visits: November 7, 1998, March 20, 1999, and June 26, 1999. None of the reconstructed notes mentions anything about lab work being ordered, the results of any lab work, or anything about an injured shoulder and whether it was healing. The entry for November 7 starts: "[Patient] request being placed on testosterone for body building. States she . . . is considering Pro-Wrestling." The notes indicate blood pressure of 118 over 64, pulse of 72, and nothing remarkable from a basic physical examination. The notes state: "Wants to body build; requests steroids." The notes report that Respondent prescribed Winstrol in 2 mg doses and explained the side effects, and Respondent was going to allow M. W. to order her steroid medication from the clinic's vendors. This entry concludes with a note for a followup visit in three months. The entry for March 20, 1999, states that M. W. had no complaints, reported getting stronger, and was happy with "bench," meaning bench-pressing, a form of weightlifting. This note states that M. W. denied experiencing any side-effects and wanted to add a second steroid: "Request to add Depo- Testosterone." The entry for June 26, 1999, notes that M. W. "feels good about herself and her outlook on life is much improved" and is "continuing to [increase] strength [with] weights." This note contains findings of a physical exam, including blood pressure of 124 over 78 and pulse of 72, and the note concludes that M. W. was doing well and Respondent planned to continue the same steroid regime. The other time that Respondent discussed the purpose of the treatment was when he was interviewed by a law enforcement officer on March 10, 2000, in the presence of Respondent's attorney. Respondent did not say anything about transgender treatment or gender identity disorder, and he was evasive when asked if he were M. W.'s physician. When asked if M. W. were ever a patient or just an employee, Respondent responded by referring to the incident when she passed out at work: "She now when you say she would ah the only time when she and I were upstairs that day. . . . And when she had the overdose." The law enforcement officer asked, "And that's like in August [1999]?" Respondent replied, "Yeah. The question was and I and I still haven't been able to define that because she asked me not to tell anybody about her problem with her drug habits and this type of scenario. So the question is whether or not she was a, whether or not honestly she was a patient of mine at that particular point in time."3 Shortly after this exchange, the law enforcement officer asked Respondent if the steroids that Respondent allowed M. W. to order through the OWC were for competitive purposes, such as weightlifting. Respondent replied, "we had a discussion about her wanting to . . . make it so that her, that she could work out harder because she was having some problems with her shoulders and these type of things "4 These reconstructed records and statements to a law enforcement officer were not casual statements uttered in an informal setting. This was information that Respondent provided to assist in the investigation of the circumstances surrounding the death of this 30-year-old woman. Except for mention of a shoulder injury in the last-cited statement--an effort by Respondent to convert the treatment objective from pure enhancement of athletic performance to a mix of enhancement of athletic performance and therapy for some undiagnosed shoulder injury--the information consistently implies that the treatment objective was to improve M. W.'s efforts in bodybuilding and weightlifting. And the mention of the shoulder injury suggests only that its healing was subordinate to the weightlifting and bodybuilding. The failure of the reconstructed records to contain any diagnostic information or progress reports on the injured shoulder precludes a finding that the treatment objective was to heal a shoulder injury. Respondent testified about the importance of confidentiality for his patients, especially M. W., as she was undergoing "gender transformation." But patient confidentiality is not an end in itself; it is a means to assuring that the patient will trust the physician with all relevant information necessary for diagnosis and treatment. Respondent implied that the requirement of patient confidentiality somehow trumped the duty not to affirmatively frustrate investigations into the death of his employee and patient. This makes no sense. Respondent's strained "explanation" for creating a misleading set of medical records yields to the simpler explanation that Respondent told the truth in these reconstructed records and in the police interview: Respondent was treating M. W. with steroids for bodybuilding and wrestling, not for gender transformation and not for an injured shoulder. These findings are supported by the fact that the first drug that Respondent prescribed M. W. was Winstrol. The anabolic effect of a steroid promotes muscularization, and the androgenic effect of a steroid promotes masculinization. Because Winstrol produces more anabolic than androgenic effect, it was long favored by females who wanted to produce muscle mass, such as for bodybuilding, without masculinization. Initiating treatment with Winstrol and following with depo- testosterone is a conventional example of the cyclical use of steroids for muscularization, not masculinization. One of Respondent's expert witnesses made an interesting observation based on the misidentification of the gender of the body of M. W. by the first responders. He testified that, if Respondent had been ordering the anabolic steroids for weightlifting and bodybuilding, M. W. must have been seriously dissatisfied with the masculinization that she had undergone. However, this observation overlooks the fact that M. W., without Respondent's knowledge, had administered to herself unknown quantities of the prescribed anabolic steroids and Deca-Durabolin. Like Winstrol, Deca-Durabolin is more anabolic, or muscle-making, than androgenic, or masculinizing-- which is consistent with M. W.'s intent to enhance her athletic performance and bodybuilding, not change her gender. Although the first responders observed some facial hair, in addition to muscularization, nothing in the record suggests that M. W. could take all of these anabolic steroids in unknown quantities without experiencing some masculinization, or that she expected no such masculinization side effects. Under these circumstances, M. W. could not legitimately have confronted Respondent over the incidental masculinization that she had experienced, while self-administered steroids whose main effect was muscularization, without running the risk that he would detect her unauthorized ordering of steroids. As noted above, there are no available medical records. Respondent testified that he gave M. W.'s medical chart and drug log "VIP" treatment to preserve confidentiality: Respondent allowed M. W. to keep her medical records and the drug log pertaining to her medications. Each time M. W. presented to Respondent, such as for an injection, she brought with her these files, according to Respondent. Petitioner contends that these records never existed, and, therefore, Respondent failed to document that he monitored the effects of the anabolic steroids that he ordered for M. W. The Administrative Law Judge credits Petitioner's version of the situation regarding medical records. At the hearing, Respondent characterized as a mere "sampling" the medical records that he had initially called a reconstruction. He implied that the reconstructed medical records were illustrative of what the records originally contained. This probably explains how he could reconstruct blood pressure readings of 118 over 64 and 126 over 78 taken six and nearly twelve months prior to the reconstruction of the records. Likely, he recalled that the values were normal and inserted these readings merely to illustrate his recollection. However, as noted above, these reconstructed records are significant for their omission of any similar illustrative reconstructions of an SBC for blood chemistry, SMAC 18 for electrolytes and kidney and liver function, and lipids for cholesterol and triglycerides. This lab work is essential, at the start of a course of treatment with anabolic steroids and periodically during treatment, to ensure the safety of any patient, especially when orally ingested anabolics--here, Winstrol--are administered, due to the possibility of liver damage. Respondent testified at the hearing that the lab results were normal, but, unlike his addition of illustrative, normal values for blood pressure and pulse, Respondent never added illustrative, normal values for this lab work. This is because he never ordered such lab work. These lab tests are common in a variety of circumstances, so they did not require the "VIP treatment" that Respondent claimed was required for the transgender treatment plan. However, Respondent never produced medical records or even lab paperwork, such as test results or invoices, documenting that these tests had been done. Also, if such records had existed and Respondent had allowed M. W. to keep them, one obvious place for them would have been in M. W.'s room at her home, but Respondent never sent anyone there to look for them after her death. As to the Standard of Care allegations, Petitioner has thus proved first, that Respondent prescribed steroids for M. W. both for muscle building (not to treat an injured muscle) and for enhancement of athletic performance; and, second, that Respondent did not order lab work to monitor the effects of the steroids that he prescribed for M. W. The evidence fails to establish that Respondent ever undertook the treatment of M. W.'s drug addiction (despite his statement to the contrary, which has been discredited). The evidence fails to establish the circumstances out of which a duty to treat could have arisen, especially within the brief time frame between Respondent's discovery of her drug problems and her death. Any evidence relevant to the remaining allegations within Count One involves the employer-employee relationship, not the physician-patient relationship, between Respondent and M. W. As to the medical records violation, Petitioner has proved that Respondent's medical records failed to adequately document the monitoring of the effects of anabolic steroids that Respondent prescribed for M. W. The evidence establishes the necessity of lab work, at the start and during steroid treatment, to ensure the safety of the patient. Without this lab work, documented in the medical records, the course of steroid treatment is not justified. The evidence fails to establish that Respondent delegated responsibilities to a person whom Respondent knew or reasonably should have known was not qualified by training, experience, or licensure to administered controlled substances to patients. Drug addiction is not a deficit in training, experience, or licensure. Even if drug addiction fell within one of these statutory categories, the evidence fails to establish any improprieties in M. W.'s administration of controlled substances to patients, and, even if the evidence proved such improprieties, the evidence fails to establish that Respondent knew of M. W.'s drug addiction at a point to have timely relieved her of her duties, or that Respondent reasonably should have known of M. W.'s drug addiction in time to do anything about it. To the contrary, Respondent's termination of these responsibilities of M. W. appears to have been timely. Petitioner has proved that Respondent prescribed and administered controlled substances--i.e., anabolic steroids--for muscle building, not the treatment of an injured muscle, and for enhanced athletic performance. Respondent has previously been disciplined. By Final Order entered on December 18, 2007, in DOAH Case No. 06-4288PL, the Board of Medicine imposed one year's suspension, a $10,000 fine, and three years' probation for failing to perform a third- trimester abortion in a hospital and failing to obtain the written certifications of two physicians of the necessity for the procedure; committing an associated medical-records violation; and committing a Standard of Care violation for failing to perform a third-trimester abortion in a hospital. Respondent's acts and omissions occurred in 2005. The Fifth District Court of Appeal affirmed the Final Order in Pendergraft v. Department of Health, Board of Medicine, 19 So. 3d 392 (Fla. 5th DCA 2009). By Final Order entered on January 28, 2010, in DOAH Case No. 08-4197PL, the Board of Medicine imposed two years' suspension, a $20,000 fine, and three years' probation for committing a Standard of Care violation for failing to a advise subsequent treating physicians that he had removed a portion of a patient's fetus and an associated medical-records violation. Respondent's acts and omissions occurred in 2006. Although Respondent has been disciplined prior to this recommended order, the acts and omissions in this case took place several years prior to the acts and omissions in the two cases described immediately above.
Recommendation It is RECOMMENDED that the Board of Medicine enter a Final Order finding Respondent guilty of violations of Section 458.331(1)(m), (t), and (q), Florida Statutes (1998), and suspending his license for one year followed by three years' probation, imposing a fine of $10,000, and assessing costs as provided by law. DONE AND ENTERED this 8th day of June, 2010, in Tallahassee, Leon County, Florida. ROBERT E. MEALE 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 8th day of June, 2010.
