The Issue The ultimate issues to be resolved in this proceeding are whether the Respondent has committed violations of provisions of law relating to the practice of medicine and, if so, what disciplinary measures are appropriate. Petitioner contends that the Respondent committed acts of gross malpractice and failed to practice medicine with the level of care, skill, and treatment which is recognized as being acceptable under similar conditions in violation of the provisions of Section 458.331(1)(t), Florida Statutes, in connection with his treatment of a patient, Dawn Rae Johannsen. Respondent contends that his treatment of the patient was proper under the circumstances.
Findings Of Fact The Respondent is a licensed medical doctor, having been issued License No. 0038405 by the Petitioner. At all times material to this proceeding, the Respondent has been licensed as a physician in Florida and has maintained a private medical practice in Miami, Florida. The Respondent specializes in the fields of obstetrics and gynecology. After graduating from medical school and completing an internship program, the Respondent completed a four-year residency program at Brookdale Medical Center, New York City, in June, 1981. The Respondent has completed the first part of examinations that could lead to his being classified as "board certified" in his specialty. When he has adequate experience, he will be eligible to take the remaining portion of the examination. While at Brookdale, the Respondent was specifically trained in termination of pregnancy, or abortion, procedures. A significant portion of the Respondent's practice is the performance of abortions. He is in good standing on the active staff of seven hospitals. He performs abortion procedures at a facility known as the Dadeland Family Planning Center. During his residency program and in private practice, the Respondent has performed approximately 3,000 abortion procedures. These procedures involved patients who were in the first and second trimesters of pregnancy. During March, 1982, Dawn Rae Johannsen was a fifteen-year-old tenth grade student. On March 11, 1982, she visited the "Women's Referral Center" in Miami to be tested for pregnancy. The results of the test were positive. On March 17, 1982, she visited the Dadeland Family Planning Center to arrange for an abortion. On Saturday, March 20, she went to the center at approximately 10 a.m. to have the abortion procedure performed. In her visits to the Women's Referral Center and to the Dadeland Family Planning Center, Johannsen used a fictitious name, Terri Marks. She also gave a fictitious telephone number and a fictitious address. It was Johannsen's desire to handle her situation on her own and to keep it secret from her parents. The Respondent was working at the Dadeland Family Planning Center on March 20, 1982; and he performed the abortion procedure on Johannsen. He identified himself to Johannsen and checked her file to see that the consent forms had been signed. He talked with Johannsen to assure himself that she understood the nature of the procedure. The Respondent then examined Johannsen. He checked the size of her uterus and estimated that she was approximately thirteen weeks' pregnant. This would place her in the second trimester of pregnancy. This conflicted somewhat with Johannsen's patient history, which reflected that she had had her last period on approximately December 31, 1981. In performing abortions, the Respondent utilizes a technique known as a "suction termination." He first inserts a speculum into the vaginal canal. A speculum is a gynecological instrument that is used to visualize the vaginal area and contents. He then cleanses the area, using Betadine on a sponge. He then places a tenaculum on the anterior cervical lip. A tenaculum is a sharp- toothed instrument which provides traction. He then utilizes a local anesthesia. Once the anesthesia takes effect, Respondent utilizes "Pratt dilators" to dilate the cervix. Once the cervix is dilated, Respondent performs a "suction curettage" which serves to evacuate most, if not all, of the contents of the pregnant uterus. At that point, the Respondent utilizes a "sharp curettage." This is a sharp surgical instrument approximately 10 inches long. It serves as an extension of Respondent's hand and is used to remove any possible products of conception which were not removed by the suction technique. With this technique, the Respondent is able to determine if any debris remains in the uterus and if the side walls are firm, smooth, and clean. At that point, the Respondent reinserts the "cannula tube" that was used to do the suction curettage. This technique is used to rid the uterus of any possible cellular debris. It is an extra step that is not performed by all physicians, but which Respondent was taught in his residency program helps assure that all debris have been removed. In performing an abortion upon Dawn Johannsen, Respondent followed his usual techniques. The suction curettage and sharp curettage procedures proceeded normally. It appeared to Respondent that eight to ten weeks of fetal material were removed by the suction curettage. The sharp curettage did not reveal additional debris. Johannsen's uterine wall was smooth and clean. When the Respondent reinserted the cannula tube, he noticed that it entered a bit farther than he had remembered it entering initially. At that time, he stopped the procedure because of the possibility of a perforation in the posterior midline uterine wall. He removed the instrument. At this point, he examined the tissue that had been removed by the first suction curettage. He examined the material in a sink in the room where abortions are performed at the center. He estimated that there were eight to ten weeks' worth of tissue. He observed the tissue and saw no evidence of any bone formation or anything other than pregnancy tissue. Respondent advised Johannsen of the possibility of a perforation. He told her that he wanted to have her wait in the recovery room for a period of at least an hour and to monitor her vital signs to make sure that she was stable. He administered Pitosin to help shrink the uterus and control bleeding. Based upon the date of the patient's last period and the amount and nature of material that had been removed, Respondent concluded that she was ten weeks' pregnant rather than the thirteen weeks that he had originally estimated based upon the size of her uterus. This was a logical conclusion, since the size of a uterus provides only a guess as to the length of a pregnancy. A two-weeks' margin of error is commonly accepted, and errors in excess of that are possible. If a patient is nervous, for example, muscle contraction is likely to cause a uterus to appear larger than its actual size. The Respondent also concluded that all material had been removed from the uterus based upon his examination of the material, the sharp curettage technique, the probable length of the pregnancy, and the fact that Johannsen's uterus immediately shrunk to a size compatible with an eight-to ten-week pregnancy. There are two dangers that follow from the perforation of a uterus during an abortion. The first of these is the danger of hemorrhaging. The second is the possibility of infection. The Respondent administered the Pitosin and observed the patient for an hour after the proceeding because of the danger of hemorrhaging. Her vital signs were monitored. After the hour passed, it appeared that she was not hemorrhaging. This is usually the case with perforations that occur in the location of the possible perforation that Respondent observed. The Respondent properly concluded that she was not hemorrhaging. He also reexamined her and found her uterus to be firm. This was consistent with his conclusion that there was no bleeding and that all of the material had been removed from her uterus. To guard against infection, he prescribed an antibiotic and told the patient to take her temperature twice a day. He also told her to observe herself for any signs or symptoms of any kind of bleeding, pain, signs of infection, nausea, vomiting, or anything out of the ordinary in terms of her daily routine. He specifically instructed her to return to the center within a week for examination. He told her that he would be there on Monday and that she should return on that date. He also said that if anything out of the ordinary occurred, she should immediately contact the center and that a doctor was on call on a 24-hour basis. The danger of infection resulting from a perforation is increased if any debris remain in the uterus. The Respondent had good medical reasons to believe that there was no such debris and that the possibility of infection with the patient Johannsen was minimal. He correctly felt that by reexamining the patient within a week and by having her monitor for signs of infection, danger from infection was minimal and remote. On the afternoon of Monday, March 22, 1982, Dawn Johannsen called the Dadeland Family Planning Center. She reported that her temperature was above 100 degrees and that she was experiencing abdominal pain. She was instructed to come to the clinic at 5:30 that afternoon, when the Respondent would be available to examine her. Johannsen did not appear at the clinic that afternoon. The Respondent was concerned that the symptoms she had reported over the telephone indicated the possibility of infection. He instructed his staff to contact her. An attempt was made by the center staff to contact Johannsen. That was impossible, however, because of the fact that Johannsen had used a fictitious name and given a fictitious phone number and address. Johannsen did not return to the clinic. Johannsen apparently continued to experience abdominal pain during ensuing days. Eventually, she told her parents what had occurred, and she was taken to her family physician. She first visited her family physician on approximately March 31. Her family physician referred her to a gynecologist. She was admitted to Baptist Hospital of Miami, Inc., on April 1, 1982. By that time, the infection was severe. The gynecologist observed fetal material, including some bone, in the patient's uterus and two perforations. He was not able to control the infection through antibiotic techniques, and a complete hysterectomy was performed on April 4, 1982. Her gynecologist felt that the bone had "quickened" and estimated that she was sixteen weeks' pregnant at the time that the abortion was performed. As a result of the hysterectomy, Dawn Johannsen will not be able to bear children. If the patient had been reexamined by the Respondent during the week subsequent to the abortion, it is very likely that material could have been removed from her uterus and the infection controlled with less dramatic techniques. The hysterectomy would in all probability have been unnecessary. There is a difference in medical opinion as to what steps the Respondent should have taken when he suspected a perforation of the patient's uterus following the abortion. Two physicians testified at the hearing that they would have immediately hospitalized the patient based upon the possibility of a perforation, alone. They would have employed observational techniques to determine the existence and the extent of any perforation. These techniques are known as a "laparoscopy" and a "laparotomy." The laparoscopy is the less severe of these procedures. It carries with it the same basic possible complications as an abortion procedure. The laparotomy is more dramatic and carries with it more severe possible complications. The doctors who testified that they would have immediately hospitalized the patient, while highly qualified in the fields of obstetrics and gynecology, had limited experience in performing abortions. Neither had performed more than 200 abortions, neither had performed any second trimester abortions, and neither had performed any abortion in which a perforation resulted. They agreed that a perforation is a risk that attends abortion procedures and that the fact that one occurs does not call into question the physician's skill. Three physicians testified that they would not have hospitalized the patient based upon the mere suspicion of a perforation. These physicians testified that most perforations are self-healing and that subjecting patients to the additional risk of the observational techniques would not be justifiable. They testified that they would have hospitalized the patient only if they were persuaded that there was a perforation and that all material had not been removed from the uterus. In those cases, the witnesses concluded that the dangers were such that steps to remove additional materials should be undertaken. Both of these lines of medical opinion are viable. It does not appear that following one or the other line of opinion would constitute gross malpractice or would depart from the level of care recognized within the medical community. When the Respondent released the patient Dawn Johannsen, he had good reason to believe that the risk of a possible perforation was minimal. She was not hemorrhaging. He properly examined her, and his observations were compatible with a conclusion that all materials had been removed from her uterus. The patient was properly instructed to observe herself for signs of infection. If she had done that and returned to the center, the sad ending of this case would likely have been different. It does not appear that the Respondent's treatment of Dawn Johannsen constituted gross malpractice or that it departed from the level of care, skill, and treatment which is recognized by reasonably prudent similar physicians as being acceptable under similar conditions and circumstances.
The Issue Whether Respondent, Doctor's Office for Women, Inc., d/b/a Today's Women Medical Center (Respondent), failed to maintain medical records as alleged in the Administrative Complaint filed with DOAH on March 28, 2012.
Findings Of Fact At all times relevant to this proceeding, Respondent has been licensed as an abortion clinic authorized to perform first and second trimester abortions. The facility at issue in this proceeding is located in Miami-Dade County, Florida. Respondent is required to comply with the following provisions of Florida Administrative Code Rule 59A-9.031: A permanent individual clinical record shall be kept on each clinic patient. Clinical records shall be complete, accurately documented, and systematically organized to facilitate storage and retrieval. Clinical records shall be complete, accurately documented, and systematically organized to facilitate storage and retrieval. Clinical records involving second trimester abortion procedures shall be kept confidential and secure. Operative reports signed by the physician performing the second trimester abortion shall be recorded in the clinical record immediately following the procedure or that an operative progress note is entered in the clinical record to provide pertinent information. Clinical records shall be kept on file for a minimum of five years from the date of the last entry. At the times relevant to this proceeding, Respondent used a consent form which, preceding the line for the patient to date and sign the form, states as follows: I, , voluntarily authorize Doctor's Office for Women, [Dr. Rosenthal], who is an independent provider and will have complete control over this procedure, follow up and any and all treatments and whomoever he may designate as his assistants, to perform upon me an elective abortion. I fully understand that the purpose of the procedure is to terminate my pregnancy, and I affirm this is to be my personal choice in the light of the alternative of continuing the pregnancy to full term. I further request and authorize him to do whatever he deems advisable if any unforeseen conditions arise in the course of the abortion that call, in his judgment, for procedures in addition to or different from those contemplated. I will fully and completely disclose my medical history, including allergies, blood conditions, prior medications or drugs taken, and reactions I had to anesthesia, medicines of [sic] drugs, I consume to my physician relying on my disclosure to be complete. I consent to the administration of anesthesia as may be deemed necessary or advisable by my physician. I understand that local anesthesia do not eliminate all pain completely and IV sedation anesthesia (Versed, Valium, Demerol) will not put me to sleep and no guarantee to the contrary have been made to me. The nature and purpose of an abortion, the procedures, the risks involved, the emotional distress, and the possibility of complications have been fully explained to me. I realize there are inherent risks of minor and major complications which may occur in this and all surgical procedures without the fault of the physician. No guarantee has been made to me. The complications include, but are not limited to: allergic reaction to the sedative or anesthesia; infection; excessive bleeding; the need for a second D&C to complete the abortion; perforation of the uterus; laceration of the cervix; hysterectomy - surgically removing the pregnancy through the abdomen; removal of the uterus as treatment of a complication (hysterectomy), also, one study indicates the possibility of breast cancer due to abortions even though these studies are not conclusive, we still recommend annual breast examinations, etc. [sic]. I release the doctors and Doctor's Office for Women and any corporation which operates this facility from any liability resulting from the above mentioned [sic] or any other complications. I further realize that I may need to be hospitalized at my own expense for treatment of such complications. I realize that such conditions can be caused by my own condition or conduct. I will accept hospitalization, if required by the doctors for any complications arising from this procedure. I understand that my complication requiring hospitalization, as a result of the termination will not be covered financially by the Doctor's Office for Women, or corporation which may operate this facility or the doctors. I understand that any questions I have will be answered before leaving the facility. If I have any questions or complications after leaving, I agree to call the Doctor's Office at this number: [xxx- xxx-xxxx]. I understand that I must return to the office for a two-week post-termination evaluation (free). I also acknowledge that if I do not return for this evaluation, I have not completed my medical care and release the Doctor's Office for Women and physicians from any liability resulting from my termination. The undersigned hereby expressly waives and releases for themselves, heirs or representatives any claims or demand which they may have of any nature, kind or description against [Dr. Rosenthal] and/or his/her assistant/s and Doctor's Office for Women, and any corporation which operates this facility and the undersigned do [sic] specifically assume any and all responsibility for the operation, acknowledging that the same is done at their [sic] request for their benefits [sic]. I certify that (if married) I have notified my husband of my intention to obtain a termination of pregnancy and I have given him the opportunity to consult with me concerning this decision. I CERTIFY THAT I HAVE READ AND FULLY UNDERSTAND THE ABOVE CONSENT TO AN ABORTION THAT THE EXPLANTAIONS THEREIN REFERRED TO WERE MADE [sic]. I GIVE THIS PERMISSION VOLUNTARILY AND OF MY OWN FREE WILL, I FURTHER REPRESENT AND WARRANT THAT I HAVE FULL LEGAL AUTHORITY TO GIVE THIS PERMISSION. On July 18, 2011, the Patient executed the foregoing consent form, and Dr. Rosenthal performed an abortion on the Patient. On September 20, 2011, Ms. Render inspected the Patient's medical records as maintained by Respondent as part of a survey of the facility. Respondent's records for the Patient reflect the events of July 18, 2011. The Patient's records reflected that the Patient was seen at an emergency room on a date between July 18 and September 13, 2011. The Patient's records did not reflect the date of that visit to the emergency room. The Patient's records reflect that the Patient had gone to the emergency room due to excessive bleeding for a sustained period of time following the abortion on July 18, 2011. The Patient's records reflect that all findings at the emergency room were "WNL" (within normal limits), but the records have no further information as to the emergency room visit. On September 13, 2011, the Patient returned to Respondent's facility, at which time Dr. Rosenthal performed on the Patient a procedure generally referred to as a D&C (dilation and curettage). The Patient did not sign a separate consent form for the second procedure. Ms. Randolph's testimony, and the consent form itself, established that the consent form authorized emergency follow-up care for the abortion, but it was insufficient to authorize the D&C some eight weeks after the abortion. Petitioner established that Respondent should have obtained written consent for the second procedure and should have maintained that consent as part of the Patient's records.1/
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that the Agency for Health Care Administration enter a final order finding Respondent guilty of failing to maintain a consent form for the second procedure, but dismissing all other charges against A Doctor's Office for Women, Incorporated, d/b/a Today's Women Medical Center. It is further recommended that the final order impose an administrative fine in the amount of $1,000.00 against A Doctor's Office for Women, Incorporated, d/b/a Today's Women Medical Center. DONE AND ENTERED this 31st day of July, 2012, in Tallahassee, Leon County, Florida. S CLAUDE B. ARRINGTON 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 31st day of July, 2012.
The Issue The issues in this case are whether the allegations of the Administrative Complaint are correct, and, if so, what penalty should be imposed.
Findings Of Fact At all times material to this case, the Respondent was an osteopathic physician, holding Florida license number OS 4478, with an address of record of 480 North Orlando Avenue, Suite 118, Winter Park, Florida 32789. On August 10, 2005, Patient B.C. met with the Respondent in his office. Patient B.C. went to the Respondent's office with a friend who was present during the consultation between the Respondent and Patient B.C. At the time of the meeting, Patient B.C., a 42-year-old female and the mother of three children, was seeking a breast lift to correct her "drooping" breasts. Prior to meeting with the Respondent, Patient B.C. completed an information questionnaire. The form directed a patient to "check off" various topics about which the patient wanted information. The form listed two topics specifically related to breasts: "breast augmentation" and "breast reduction." Patient B.C. checked the box for augmentation. At the hearing, Patient B.C. testified that she was familiar with breast lift procedures because a family member had undergone a similar procedure. Patient B.C. testified that during her consultation with the Respondent, she specifically told the Respondent that she was not seeking to have her breasts enlarged, but was unhappy with the drooping appearance and wanted her breasts lifted to correct the droop. According to Patient B.C., the Respondent told her that she was not an appropriate candidate for a breast lift and that he could achieve the result she sought with an implant, with the possibility of a subsequent "crescent lift" after healing from the augmentation. The medical term for breast droop is "ptosis." Breast ptosis is graded according to the "Regnault" scale into one of three categories based upon the location of the nipple areolar complex relative to the inframmary fold. Although there was some disagreement among testifying experts about the grade assigned to Patient B.C.'s ptosis, the greater weight of the evidence establishes that Patient B.C.'s ptosis was severe and was classified as Grade III. According to the testimony of Dr. Anthony Dardano, a grade one ptosis can be treated with augmentation to increase breast volume. A grade two ptosis should generally be treated with a breast lift. A grade three ptosis should be treated with a mastopexy, of either a full-scar or a vertical type. Augmentation of a grade three ptosis essentially results in a larger drooping breast. Dr. Dardano testified that Patient B.C.'s ptosis was of such severity that a full mastopexy procedure was required to correct it and that an augmentation and crescent lift would not have corrected the ptosis. Dr. Dardano's testimony was persuasive and is accepted. During the initial consultation, the Respondent described the augmentation procedure to Patient B.C., and she ultimately became convinced that the augmentation and possibly a subsequent crescent lift would correct the ptosis. The Respondent disputes the patient's recollection of the initial consultation. The Respondent testified that he advised Patient B.C., whom he described as a "borderline" patient, to seek the opinion of a plastic surgeon. He testified that he did not tell her that she was not a candidate for a breast lift and that she chose to undergo the augmentation after being fully informed as to the entire range of surgical procedures because she wanted to avoid scars from a mastopexy. Patient B.C. had no recollection that the Respondent had suggested that she seek the opinion of a plastic surgeon. There was no documentation in the Respondent's medical records that he advised her to do so. On cross examination, the Respondent was asked a number of questions related to the specific discussion he had at the initial consultation with Patient B.C., particularly regarding whether procedures other than augmentation were addressed. The Respondent testified that he makes the same presentation at initial consultations between six and ten times daily and that he covers the full range of options at each presentation. He testified that he does not document the specific discussion that occurs during the initial consultation as he does not believe that the person is his "patient" at that time. He does not create a medical record documenting his interaction with a patient until the patient decides to allow him to perform surgery. On redirect, he was invited by his legal counsel to present the presentation he makes to potential patients during initial consultations. The Respondent's response to the question was almost wholly a discussion of the augmentation procedure and the post-augmentation recovery period. Other than stating that he determines whether someone is a candidate for breast augmentation, no part of his response to the question indicated that there was any discussion of the entire range of mastopexy, which could address the patient's concern or that the Respondent routinely made referrals outside his area of expertise. The greater weight of the evidence establishes that the Respondent discusses with potential patients the procedures that he performs. There is no credible evidence that the Respondent advised Patient B.C. to consult a plastic surgeon about her ptosis. His testimony that he specifically recalled referring Patient B.C. to a plastic surgeon was not persuasive or credible and is rejected. Several months after the initial consultation, Patient B.C. executed consent forms for the breast augmentation. She paid a total of $4,000 in at least two installments in advance of the surgery. At the hearing, Patient B.C. acknowledged having received and read extensive materials provided by the Respondent as part of the informed consent process. She also researched augmentation after the initial consultation and was aware of the procedure prior to the surgery. Informed consent is not at issue in this proceeding. Patient B.C. went to the Respondent seeking a breast lift to correct the ptosis, and it is reasonable to presume that part of the consent process was the fact that the Respondent dissuaded her from the full breast lift procedure (which he does not perform) and advised her that he could achieve the results with the augmentation, perhaps followed at a time uncertain by a crescent lift. On November 25, 2005, the Respondent performed a bilateral breast augmentation on Patient B.C. On the day of the surgery, Patient B.C. was taken to the Respondent's office by the same friend who had accompanied her on the initial consultation. Patient B.C. was given medication to "relax" during the procedure, and the surgical site was numbed, but Patient B.C. was awake throughout the procedure. The Respondent's surgical note says he placed the implants under the patient's pectoral muscle. According to the deposition testimony of Dr. James L. Baker, M.D., a plastic surgeon, Dr. Baker believes that the implants were placed above the pectoral muscle. The evidence establishes that in an appropriate candidate for augmentation, either location would have been an acceptable placement. The Respondent used Mentor High Profile 380cc saline implants, which he filled to the maximum of 450cc with saline. After inflating the implants, but before completing the procedure, the Respondent sat Patient B.C. up and allowed her to view the result. He also allowed Patient B.C.'s friend to come into the room and observe the result, at which time the friend commented on how large the implants appeared to be. After the procedure, Patient B.C. returned for several follow-up visits to the Respondent's office, and, during the visits, she expressed her concern that her augmented breasts were larger than she wanted. She testified that the Respondent told her it would take time for the implants "to drop" and for swelling to subside. During the follow-up period, Patient B.C. had a routine annual gynecological examination and discussed her augmentation with her gynecologist, who referred her to a plastic surgeon, Dr. Baker. Patient B.C. went to consult with Dr. Baker in January 2006, by which time Patient B.C. had decided she wanted the implants removed. She was provided three referrals by Dr. Baker, and she chose to make an appointment to see Dr. Orlando Cicilioni. Patient B.C. met with Dr. Cicilioni in February 2006 and discussed removal of the implants, but Patient B.C. lacked the funds to follow through with the removal. At the time of the hearing, Patient B.C. had not yet had the implants removed. Patient B.C. described her unhappiness with the implant procedure performed by the Respondent. She testified that the implants remained "up higher" with the breast hanging off of the implants. Patient B.C.'s testimony is consistent with photographs taken post-augmentation. Patient B.C. testified that she wanted the implants removed but lacked the funds to do so, and eventually to have the breast lift she sought when she first approached the Respondent. Comparison between pre-operative photos and those taken at various dates following the procedure demonstrate that ptosis is still clearly present. Although the implants have somewhat settled into a lower position, the patient's chest area is essentially thrust forward, the unnatural outline of the implants visible (especially in the side view), with the patient's breasts sitting over the implant. Portions of the breast skin are shiny and appear to be stretched. In reviewing the photographs, the Respondent asserted that the breasts had been lifted by the augmentation. However, the nipple-areola complex is in essentially the same position on the breast as prior to the surgery. Very little, if any, breast lift was achieved through the augmentation process. The Respondent also testified that although Patient B.C. could possibly benefit from a post-augmentation crescent lift, "in all honesty, the left side might need a little bit of a vertical component," which would require surgery by a plastic surgeon. Dr. Kaplan testified that a crescent lift may achieve a lift of 2 to 3 centimeters, although he testified "I'm usually happy if I get 1 to 2." Dr. Dardano identified the surgical result as a "Snoopy dog defect," in reference to the nose of the cartoon character, and described it as a deformity.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health, Board of Osteopathic Medicine, enter a final order finding Barry J. Kaplan, D.O., in violation of Subsection 459.015(1)(x), Florida Statutes (2005), and imposing a fine of $6,500; a probationary period of three years, with such conditions as determined appropriate by the Department of Health, including additional educational requirements; and requiring that the Respondent refund to Patient B.C. the $4,000 fee she paid to him. DONE AND ENTERED this 7th day of September, 2007, in Tallahassee, Leon County, Florida. S WILLIAM F. QUATTLEBAUM 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 7th day of September, 2007. COPIES FURNISHED: J. Blake Hunter, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Thomas E. Dukes, III, Esquire McEwan, Martinez & Dukes, P.A. Post Office Box 753 Orlando, Florida 32802-0753 Pamela King, Executive Director Board of Osteopathic Medicine Department of Health 4052 Bald Cypress Way, Bin C-06 Tallahassee, Florida 32399-1701 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 Dr. Ana M. Viamonte Ros, Secretary Department of Health 4052 Bald Cypress Way, Bin A-00 Tallahassee, Florida 32399-1701
The Issue The issue presented is whether Respondent is guilty of the allegations contained in the Administrative Complaint filed against him, and, if so, what disciplinary action should be taken against him, if any.
Findings Of Fact At all times material hereto, Respondent has been licensed as a physician in the State of Florida, having been issued license number ME 0017602. He graduated from St. Louis University School of Medicine in 1966. He taught obstetrics and gynecology at the Portsmouth Naval Hospital in 1970-1972. He was board-certified in obstetrics and gynecology in 1972 and retired from the active practice of medicine in 1996. Licensed in Missouri, Virginia, and Florida, Respondent has never been disciplined by Petitioner or any other licensing authority. During his active practice of obstetrics and gynecology, Respondent specialized in high-risk obstetrics, i.e., the treatment of patients whose lives and pregnancies are at risk during the course of their pregnancy. He treated patients with diabetes, with heart disease, with blood disease, and with abnormal pregnancies such as ectopic pregnancies. He is well respected in the medical community, including by others who practice high-risk obstetrics. He enjoys a reputation for being a caring, concerned, intelligent, and capable physician. On November 30, 1993, R. C. was a 35-year-old patient who had been seen previously by Respondent's associate but not by Respondent. She had a long history of infertility and had been treated with fertility drugs. She had had one ruptured ectopic pregnancy that resulted in the removal of her right ovary. She had three failed attempts at in vitro fertilization. She reported to Respondent that she felt pregnant. She had taken three home pregnancy tests, which were positive. Her HMO primary care physician, following laboratory confirmation of her pregnancy, had referred her to Respondent. She advised Respondent that her last menstrual period was October 16, 1993. Respondent conducted a physical examination and agreed that she was pregnant. Her breasts were tender, and her uterus may have been a little soft but it was not enlarged. The presence of a normal-sized uterus at six weeks gestation, while not unusual, is one possible indication that a woman might have an abnormal pregnancy or be in the process of having a miscarriage. It raised the suspicion that the nature of her pregnancy, intra-uterine versus abnormal, must be considered by Respondent. However, enlargement of the uterus during pregnancy is different for each patient. Significantly, R. C. did not have any bleeding. She had no abdominal pain, and no adnexal masses were palpated. Essentially, she was asymptomatic for an abnormal pregnancy. Because of her history, Respondent considered R. C. to be at a higher risk for an abnormal or ectopic pregnancy than that expected for a normal female from the general population. It is generally understood that the risk of a repeat ectopic pregnancy is between 10 and 15 percent. Respondent was aware that even with an ectopic pregnancy, the uterus undergoes many of the changes associated with an early normal intra-uterine pregnancy, including an increase in uterine size and softening of the cervix. These changes occur as a result of the hormones circulating through the body during the early stages of pregnancy. Concerned since R. C. was at risk although asymptomatic, Respondent decided that the prudent course would be to evaluate R. C.'s pregnancy to rule out an ectopic or other abnormal pregnancy. Consequently, he took steps different from those that would be taken during a normal routine pregnancy. Respondent obtained an immediate quantitative human chorionic gonadotropin (hCG) value that day. The quantitative hCG is a diagnostic test available to physicians to evaluate the progress of a pregnancy when there is concern as to its nature. It is not a test that is ordered when there is no concern as to the nature of the pregnancy. The test measures the secretions of the placenta. It confirmed R. C.'s pregnant state and was an indicator of the presence of a placenta somewhere in her body. The hCG value was reported as 7,371. By itself, the hCG value told Respondent little about R. C.'s pregnancy. It did, however, provide some comfort that R. C. might have an intra-uterine pregnancy, particularly given her lack of symptoms for an ectopic pregnancy. It is generally understood that less than 25 percent of ectopic pregnancies have hCG values greater than 6,000. With an hCG value greater than 7,000, R. C. was in the group more likely to have an intra-uterine pregnancy. Her lack of symptoms also indicated that she had an intra-uterine pregnancy. It is generally understood that bleeding is present in over 85 percent of cases where there is an ectopic pregnancy. Pain is present in over 90 percent of the cases where there is an ectopic pregnancy, and over half of such women have palpable adnexal masses or lumps. R. C. was not experiencing any of what are known as the classic triad of symptoms for an ectopic pregnancy. Respondent obtained the hCG to be used as a baseline. The quantitative hCG is best used serially, and a single value has no real meaning in evaluating the nature of a pregnancy. By repeating the test at certain intervals, a physician can observe where the pregnancy might be going from a hormonal point of view. The initial value is a starting point from which other tests can be used to determine if the pregnancy is likely normal or abnormal. In an early normal intra-uterine pregnancy, the hCG values generally double approximately every 48 hours. Then, the rise begins to plateau, and the doubling time lengthens. To determine the course of a pregnancy, repeat tests of the hCG at set intervals can be an aid in the diagnosis of ectopic pregnancies. The possibility of an ectopic or other pathologic pregnancy exists when the hCG value fails to rise in accordance with the expectations of a normal intra-uterine pregnancy or does not rise at all. Although R. C. was asymptomatic, given her history, Respondent determined that he should obtain a repeat hCG and an ultrasound examination to confirm the presence of an intra- uterine pregnancy. He scheduled the repeat hCG and the ultrasound to be performed 7 to 10 days from that visit, or December 9, 1993. Respondent's plan of treatment was reasonable under the circumstances. If R. C. had had any of the classic symptoms consistent with an ectopic pregnancy, the standard of care would have required an immediate ultrasound. However, R. C. did not have any symptoms. It is a matter of physician judgment as to when an ultrasound examination and repeat hCG should be obtained for an asymptomatic patient. When there is no urgent need for the tests, the standard of care does not define the time frame in which the tests should be performed. Respondent wanted to wait another 7 to 10 days to allow for better visualization of the fetus on the ultrasound and to avoid a misinterpretation of the result of the repeat hCG test. By waiting, Respondent would likely obtain more useful information from the ultrasound than if the ultrasound were performed that day or during the next few days. He wanted to combine the findings of the ultrasound with the results of the repeat hCG test. Reasonably-prudent, similarly-trained physicians support Respondent's conclusions. The possibility of a misinterpretation of the hCG results is lessened by the passage of a reasonable period of time between tests. Before she left the office on November 30, 1993, R. C. was asked to contact Respondent in two days to obtain the results of her initial hCG test and to follow-up on her condition. On December 2, 1993, R. C. contacted Respondent. During their telephone conversation, R. C. expressed concern that her pregnancy might be in the fallopian tube rather than the uterus. Respondent wanted to calm her fears. He inquired as to how she was doing, and she reported that she was doing fine, no bleeding or pain. Generally, an ultrasound is not performed until at least the fifteenth or sixteenth week. After speaking with R. C. on December 2, 1993, Respondent continued with his plan to obtain an ultrasound evaluation of R. C. in her 7th or 8th week of gestation. Her history indicated that Respondent should confirm the nature of her pregnancy, and Respondent took those steps necessary to monitor and confirm R. C.'s condition. At approximately 6:00 p.m. on December 6, 1993, R. C. contacted Respondent's office and spoke with his midwife. R. C. complained that she was having some cramping that began after she had eaten a very heavy meal. This is not an unusual complaint during a pregnancy. R. C. reported that the cramping was resolving, but she just wanted to touch base with someone. The midwife advised her to go to the emergency room if the cramping worsened during that evening or if she was concerned. The midwife also advised R. C. that if she felt better by morning but not completely better, she should come in to the office. If she felt fine, she should keep her scheduled appointment for the ultrasound. The advice given to R. C. by the midwife was appropriate and consistent with the standard of care. R. C. began to experience severe lower abdominal pain on the morning of December 7, 1993, and was taken to the emergency room of Bethesda Memorial Hospital. She did not have any vaginal bleeding. Respondent was present in the hospital when R. C. arrived at the emergency room, and he came immediately upon being called. An ultrasound was performed and confirmed that the uterus was empty except for a pseudo-gestational sac. A viable ectopic pregnancy was seen in the left adnexal area with an estimated gestational age of 6 weeks. Respondent assessed R. C. as having a leaking tubal pregnancy, and he had her taken to surgery immediately following the ultrasound. Respondent removed her left tube and ovary and provided blood transfusions due to free blood found in the abdomen. R. C. experienced a fever following the surgery, but she recovered and was discharged from the hospital. Respondent's plan and action in evaluating R. C. on her November 30, 1993, visit to his office were in accordance with the standard of care, and were reasonable and appropriate. The patient's telephone report of doing well on December 2, 1993, strengthened Respondent's judgment that there was no immediate need to obtain an ultrasound and repeat hCG and that he could wait until those tests were likely to be reliable.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding Respondent not guilty and dismissing the Administrative Complaint filed against him in this cause. DONE AND ENTERED this 23rd day of February, 2000, in Tallahassee, Leon County, Florida. LINDA M. RIGOT Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 23rd day of February, 2000. COPIES FURNISHED: Tanya Williams, Executive Director Board of Medicine Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0750 Angela T. Hall, Agency Clerk Department of Health 2020 Capital Circle, Southeast Bin A02 Tallahassee, Florida 32399-1703 Britt Thomas, Esquire M. Rosena Hitson, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Grover C. Freeman, Esquire Jon M. Pellett, Esquire Freeman, Hunter & Malloy 201 East Kennedy Boulevard, Suite 1950 Tampa, Florida 33602
The Issue 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
Findings Of Fact The Petitioner is the state agency charged by statute with regulating the practice of medicine in Florida. At all times material to this case, John Isaac Delgado (Respondent) has been a physician in the state, holding Florida license number ME 0054871. The Respondent's last address of record is 7820 North Armenia Avenue, Tampa, Florida, 33629. The Respondent has been licensed to practice in Florida since 1989. At about 8:30 p.m. on February 9, 1992, Patient W. S. (Patient) presented to the Emergency Room at St. Joseph's Hospital, Tampa, apparently complaining of right lower quadrant pain. Immediately prior to being seen at the emergency room, the Patient had been playing cards with friends and had apparently fainted. The Patient, a 74 year old obese white male, had a history of diabetes, coronary artery disease and had a previous myocardial infarction. At the emergency room, the Patient was initially examined by John C. Siano, M.D. Dr. Siano ordered chest and abdominal x-rays. The Respondent was the internist on call at the time the Patient was examined in the emergency room. Dr. Siano contacted the Respondent and notified him of the situation. The Respondent examined the Patient at about 10 p.m. The examination was extensively documented. At the time the Respondent initially examined the Patient, the Patient provided an incomplete summary of his symptoms. The Patient had apparently informed emergency room personnel of severe pain; however, this information was not provided to the Respondent. The Respondent was aware only of intermittent abdominal pain. The Patient's emergency room records were missing at the time of the Respondent's examination. The Respondent unsuccessfully attempted to locate the Patient's records during his examination of the patient. Upon examination, the Respondent determined that the Patient's blood pressure was within normal range and was stable. The Patient was alert and oriented. Vital signs were normal. The patient appeared to be in stable condition. While in the emergency room, the Patient had a bowel movement which tested positive for the presence of blood. A nasogastric tube exiting from the Patient indicated "coffee grounds" material. These factors are indicative of a gastrointestinal problem. The presence of blood in the intestinal tract and abdominal pain is indicative of a gastrointestinal disorder. The evidence fails to establish that the patient presented an emergency condition at the time of the Respondent's examination. Back pain is a symptom of an expanding abdominal aortic aneurysm. An expanding aneurysm presses against nerves and muscle in the back and sides of a patient. In this case, the aneurysm was of considerable size; nonetheless, the evidence fails to establish that the Patient informed the Respondent of severe back pain. Severe continuing abdominal pain may be a symptom of a ruptured abdominal aortic aneurysm. The evidence fails to establish that the Patient informed the Respondent of severe continuing abdominal pain. There was no palpable pulsatile mass in the Patient's abdomen which would have been indicative of an aneurysm. There was no "bruit" sound emanating from the patient's abdomen. Such sounds are indicative of an aneurysm. There was no asymmetry of pulses in the Patient's legs which would have been indicative of the aneurysm. Hypotension, such as may result in fainting, can be indicative of an aneurysm. The patient was hypotensive when he arrived at the emergency room; however, treatment with intravenous fluids brought the Patient's pressure back to a normal range within a few minutes, indicating that internal bleeding was not significant. Based on the symptoms described by the patient and on review of the patient's condition, the Respondent's tentative diagnosis was upper gastrointestinal bleeding, likely peptic ulcer disease with bleeding secondary to chronic aspirin usage and colonic polyps. There was also a suggestion of acute diverticulitis with associated bleeding. The Respondent ordered a series of abdominal x-rays be taken. The Respondent ordered appropriate diagnostic studies based on his tentative diagnosis. The tests were scheduled for the morning. The Respondent also requested a surgical consultation, which was also scheduled for the morning. Based on the examination and discussion with Dr. Siano, the Respondent admitted the Patient to a regular floor for further observation. At the time the Patient was admitted, the Respondent had not reviewed the results of the abdominal x-rays. The Respondent did not review the x-rays prior to leaving the hospital that night. The evidence is insufficient to establish that the Respondent's failure to review the x-rays prior to admission or prior to leaving the hospital for the night violated the acceptable standard of care. Based on the patient's condition as expressed to the Respondent and on the results of the examination, the evidence fails to establish that the Respondent should have diagnosed the situation as an aneurysm. The mere existence of an aneurysm is not a surgical emergency. Whether to surgically treat an aneurysm depends on a number of other factors. A ruptured aneurysm is an emergency life threatening condition. Time is critical when responding to a ruptured aneurysm. The evidence is insufficient to establish that the Respondent knew or should have known that the Patient was suffering from a ruptured aneurysm. In the morning of February 10, 1992, a general surgical consultation was done by Frederick Reddy, M.D. Dr. Reddy examined the patient and reviewed the abdominal x-rays which had been taken on the Respondent's orders. According to Dr. Reddy, at the time of his exam the patient complained of intermittent abdominal pain, and said that he had a history of back pain, but did not complain of back pain at that time. Dr. Reddy's review of the x-rays indicated the presence of calcification. While calcification is indicative of an possible aneurysm, the evidence fails to establish that the Patient's aneurysm is clearly indicated by the x-rays. Dr. Reddy saw no indication of rupture, but referred the case to a radiologist and ordered a CT scan on the radiologist's recommendation. The CT scan indicated that an aneurysm had ruptured. The Patient was taken to surgery where G. K. James, M.D. repaired the ruptured aneurysm and performed an aortobifemoral bypass graft. The Patient's condition deteriorated and he expired on February 10, 1992. The evidence fails to establish that the outcome of the case would have been different had the Respondent diagnosed the problem as a ruptured abdominal aortic aneurysm or had the surgical procedure been performed at an earlier time after the Patient's arrival at the hospital emergency room.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Agency for Health Care Administration enter a Final Order dismissing the Administrative Complaint filed in this case. DONE and ENTERED this 27th day of February, 1996, in Tallahassee, Florida. WILLIAM F. QUATTLEBAUM, Hearing Officer Division of Administrative Hearing The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 27th day of February, 1996. APPENDIX TO RECOMMENDED ORDER, CASE NO. 95-1981 To comply with the requirements of Section 120.59(2), Florida Statutes (1993), the following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact. The Petitioner's proposed findings of fact are accepted as modified and incorporated in the Recommended Order except as follows: 1. Rejected, not supported by cited evidence. Petitioner's exhibit Number 1 identifies the Respondent's address as set forth herein. Rejected. The greater weight of evidence fails to establish that the x-rays revealed the presence of a ruptured aneurysm. The ruptured aneurysm was diagnosed after a CT scan and review by a radiologist. Rejected, subordinate. While the statement that the cited physician always reads his ordered x-rays is correct, the evidence fails to establish that failure to do so is a violation of the acceptable standard of care. Rejected. The cited evidence does not establish that the x-ray "very clearly" suggests the aneurysm. Rejected. The greater weight of the evidence fails to establish that the Patient described pain indicative of an aneurysm to the Respondent. Rejected. No evidence that the Respondent was aware of the statement made by the Patient. Rejected. The greater weight of the evidence fails to establish that the Patient described pain indicative of an aneurysm to the Respondent. Rejected. The greater weight of the evidence fails to establish that the Patient's condition as determined by the Respondent required an immediate consultation. Rejected. The greater weight of the evidence fails to establish that the Patient's condition as determined by the Respondent indicated a course of treatment other than as set by the Respondent. Rejected, subordinate. Rejected. Not supported by the greater weight of credible and persuasive evidence. Respondent's Proposed Findings of Fact. The Respondent's proposed findings of fact are set forth in unnumbered paragraphs, many of which fail to contain citation to the record as required by Rule 60Q-2.031(3), Florida Administrative Code. Proposed findings which cite to the record are accepted as modified and incorporated in the Recommended Order, or are otherwise rejected as subordinate or as recitation of testimony. COPIES FURNISHED: Douglas M. Cook, Director Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Jerome W. Hoffman General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Dr. Marm Harris, Executive Director Board of Medicine Agency for Health Care Administration Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792 Steve Rothenburg Senior Attorney Agency for Health Care Administration 9325 Bay Plaza Boulevard, Suite 210 Tampa, Florida 33619 Clifford L. Somers, Esquire 3242 Henderson Boulevard, Suite 301 Tampa, Florida 33609
