The Issue Whether disciplinary action should be taken against the license to practice medicine of Respondent, Carl Fromhagen, M.D., based on allegations that he violated Subsections 458.331(l)(k),(m) and (t), Florida Statutes, as alleged in the Administrative Complaint in this proceeding.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing, the following findings of facts are made: Petitioner is the state agency charged with regulating the practice of medicine in the State of Florida pursuant to Section 20.43, Florida Statutes, and Chapters 455 and 458, Florida Statutes. At all times material to this proceeding, Respondent was a licensed physician in the State of Florida, having been licensed in 1956 and issued License No. ME 0007027. Respondent is board-certified in Obstetrics and Gynecology (1967). He is 74 years old and now has an office- based practice treating only gynecological patients. Patient K. B., a 46-year-old female, first presented to Respondent on September 6, 1990, with menopausal complaints. Her patient's history reflects that she reported a family history of breast cancer. On February 12, 1992, Patient K. B. presented to Respondent with complaints of a mass in her left breast. Respondent palpated a mass in K. B.'s left breast and, although he did not note the size of the mass in his office records, the records contain a diagram showing the location of the mass. Petitioner testified that it was his practice that when he discovered a mass of less than 2.5 centimeters, he did not describe the size because its too hard to identify the exact dimensions smaller than an inch. Respondent ordered a mammogram for Patient K. B. which was performed on February 19, 1992, and was interpreted as revealing no evident neoplasm (cancer). Respondent saw Patient K. B. in his office on the following dates (after the mammogram): March 30, 1992; May 21, 1992; August 31, 1992; April 19, 1993; April 27, 1993; May 4, 1993; May 11, 1993; May 18, 1993; September 21, 1993; and November 16, 1993. In addition, Patient K. B. had telephone contact with Respondent's office staff to have prescriptions refilled and was mailed examination reminder notes. Patient K. B. testified that she and Dr. Fromhagen discussed the breast mass "every checkup, every time I was there." She inquired about a follow-up mammogram and Dr. Fromhagen indicated that she could wait two years. He did not mention a biopsy, excision, or referral to another physician at anytime. Patient K. B. and Respondent agree that Respondent examined and palpated the breast mass during her physical examinations which took place approximately every six months. During civil litigation that preceded the instant administrative hearing, it became apparent that there were two different sets of office records for Patient K. B. Patient K. B. testified that during the civil action she brought against Respondent in 1996, Respondent had produced medical records, purported to be hers that did not accurately reflect her treatment. She recalled that upon comparing the medical records Respondent had produced in the civil action with the records she had obtained from Respondent's office in December 1994, she discovered that Respondent had "augmented" her records, which she reported to her attorney. In May 1994, the offices of Dr. Paul Straub, who became Patient K. B.'s new treating physician as a result of a change in her group health insurance, requested her medical records from Dr. Fromhagen's office. Dr. Fromhagen testified in the instant hearing that "at the time . . . I compared the chart [Patient K. B.'s records] with . . . 'day sheets' and because I felt the records did not reveal everything that Dr. Straub should be aware of, I rewrote certain portions of them to reflect things that were on the day sheets that I hadn't already written down and then [in May 1994] sent the records to Dr. Straub." Patient K. B. testified that, "the night before my surgery" [December 1994] she received a call from Dr. Fromhagen's office asking if they could send her records to Dr. Straub. In the course of that discussion, Patient K. B. advised that she had been diagnosed with breast cancer and was scheduled for surgery. That same evening, shortly after the phone discussion with Dr. Fromhagen's office, Patient K. B. went to Dr. Fromhagen's office and obtained a copy of her medical records. These records did not contain the "rewritten portions" Dr. Fromhagen reported as having been done in May 1994. Dr. Fromhagen testified that he started keeping "day sheets" when he first started practicing in 1960. The "day sheets" (Respondent's Exhibit 2) are essentially a daily calendar organized by time which lists the name of patients to be seen that day and then notes such as "ovarin cyst," "vaginitis," "preg?" These "day sheets" were not mentioned in either of Dr. Fromhagen's depositions taken in 1996 in the civil action. In Petitioner's Exhibit 10, a July 3, 1997, letter to M. S. Sutton, an Agency for Health Care Administration investigator, Dr. Fromhagen attempts to explain his record- keeping practice for patients, Dr. Fromhagen acknowledges rewriting his charts and states, "I would carefully review the chart and address any portions that I felt were not completely explanatory, or that I thought need information to assist the subsequent physician. I now understand that I should have noted the changes as late entries and dated them the date written." No mention was made of "day sheets" in this letter. Dr. Fromhagen testified during a deposition taken in the civil action that his standard practice was "to make entries in the chart right away," that he never put it off, and that he had not done anything different in Patient K. B.'s case. Dr. Fromhagen acknowledged that during a deposition taken in the civil action he had incorrectly testified that he had not made changes in Patient K. B.'s medical record. The following is a comparison of the significant difference between Petitioner's Exhibit 9, Patient K. B.'s original medical record, and Respondent's Exhibit 3, Patient K. B.'s "augmented" medical record. Please note: Patient K. B. became Dr. Fromhagen's patient on September 6, 1990. No changes were made in the "Gynecologic History and Physical Examination" (Patient K. B.'s medical record) on any entry until March 30, 1992. Changes are highlighted. Date: March 30, 1992 Original record: "Mammogram was neg. palpation indicates mass much smaller. Will follow" Augmented record: "Mammogram reported as no evidence of neoplasm. Palpation indicates to me that mass is smaller. Discussed removing it" Date: May 21, 1992 Original record: "Dysuria General Malaise. Pelvic unremarkable. Urine - pus. Rx Macrodantin" Augmented record: "Dysuria. Mailaise. Pelvic unremarkable. Urine - pus. Rx Macrodantin" Date: August 31, 1992 Original record: "Introital lesions. Pelvic area feels congestion and cramping sensation. Pelvic- ulcers-blisters at introitus but very small. Herpes? Rx Zoirax" Augmented record: "Introital lesions. Lower abd cramping. Pelvic - herpetic ulcers at introitus. Rx Ziorax" Date: April 19, 1993 Original record: "Last mammogram revealed no concern. Dysuria. Frequent UTI. Had a cysto before. Rhinorrhea. Vulvar irritation. GenPE. Breasts unchanged. Pelvic - fungus. Rx She has Monistat. Urine - pus Macrodantin. RV Cysto" Augmented record: "Last mammogram revealed no neoplasm but mass still present and I suggested another x-ray now or removal of mass if she wishes. Dysuria. Has frequent UTIs. Had a Cysto before. Rhinorrhea. Vulvar irritation. Gen PE - nasal turbinates swollen. Breasts unchanged. Pelvic-fungus. Rx she has Monistat for fungus. Macrodantin RV Cysto" Date: April 27, 1993 Original record: "Cysto: stricutre. Proximal urethra & trizone inflamed and granules. Bladder capacity - first desire to void at 200 c.c. RV dilations" Augmented record: "Cysto-urethral stricture. Proximal urethra & trizone inflamed & granular. Urethra L46. Bladder capacity - first desire to void at 200 cc. Rx RV dilations" Date: May 18, 1993 Original record: "No urinary complaints now. Sounded #32 irrigated AgNO3. This concludes dilations" Augmented record: "No urinary complaints now. Sounded #32, irrigated AgNO3. This concludes diations. She has not gotten this years mammogram yet" Date: October 11, 1993 Original record: "Rem sent" [entry made by office staff]" Augmented record: "Reminder note sent - Exam due." [entry made by office staff]" Date: November 16, 1993 Original record: "On Premarin.625. Starting to awaken in the middle of the night again Nervous. No flashes. Bladder OK. New glasses. Trouble adjusting to fidders bifocals. GenPE, breasts & pelvic unchanged. Pap change to Premarin 1.25" Augmented record: "On Premarian.625. Starting to awaken in the middle of the night again. Very nervous. No flashes. Bladder OK. Finds it hard to adjust to her new bifocals. Gen PE unchanged. Breasts - mass still present. Again suggested she get a yearly mammogram or have mass excised. She has not arranged for a mammogram as she said she would. Pelvic unchanged. Rx Increased dose of Premarian to 1.25" The entries made in patient K. B.'s "augmented" record (Respondent's Exhibit 3) were not noted to be "late entries" nor were they dated. Both expert witness opined that this fell below the standard of care. Most of the "late entries" made by Respondent in the "augmented" record (Respondent's Exhibit 3) are a self-serving attempt by Respondent to create the impression that he had encouraged Patient K. B. to have follow-up mammograms or to have the breast mass excised. If the "augmented" record (Respondent's Exhibit 3) was a true reflection of the treatment rendered Patient K. B. by Respondent, his treatment could possibly have met the "standard of care." I find that the "augmented" record does not reflect the treatment Patient K. B. received, but that the original record (Petitioner's Exhibit 9) is the more credible document and accurately reflects Respondent's treatment of Patient K. B. Dr. Nelson, who testified as an expert witness, testified that Dr. Fromhagen fell below the standard of care in that (relying on both the original record and "augmented" record) between March 30, 1992, and April 13, 1993, he did not "deal with the breast mass, did not report discussion of treatment options with the patient, did not order a follow-up mammogram within 12 months." Again relying on both records, Dr. Nelson testified that Dr. Fromhagen fell below the standard of care for maintaining medical records when he failed to record his examination of Patient K. B.'s breasts and palpation of the mass which he reported as having been done "every visit she made." Both Dr. Von Thron, who also testified as an expert witness, and Dr. Nelson agreed that the standard of care requires that for any revision of medical records, if a change is made, a line is made through the original so it can be read and then the correction is made and the change is dated and initialed. If an additional statement is entered into the medical record, it should be dated and initialed. Dr. Fromhagen did not date or initial the changes or additions to Patient K. B.'s medical record when he created the "augmented" record. Both expert witnesses testified that this fell below the standard of care for medical record-keeping. Dr. Von Thron, referring to the original record, opined that Dr. Fromhagen did not comply with the standard of care for essentially the same reasons as expressed by Dr. Nelson. He opined that the "augmented" record indicates that Dr. Fromhagen complied with the standard of care.
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 Respondent guilty of violating Subsections 458.331(1)(k), (m), and (t), Florida Statutes (1993), and imposing the following: A $1,000.00 fine for each violation, for a total of $3,000.00; and A one-year suspension followed by two years' probation; Ten hours of continuing medical education in ethics; An appropriate medical education course in medical record-keeping. DONE AND ENTERED this 5th day of March, 2001, in Tallahassee, Leon County, Florida. JEFF B. CLARK 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 5th day of March, 2001. COPIES FURNISHED: George Thomas Bowen, II, Esquire Law Offices of Donald Weidner, P.A. 11265 Alumni Way, Suite 201 Jacksonville, Florida 32246 John E. Terrel, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Theodore M. Henderson, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
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 the Respondent committed the violations alleged in the administrative complaints; and, if so, what penalty should be imposed.
Findings Of Fact The Department is the state agency charged with the responsibility of regulating the practice of medicine pursuant to Florida law. The Respondent is a licensed physician in the State of Florida having been issued license number ME 0043628. In September, 1987, J.B., a patient at Hialeah Hospital, underwent exploratory surgery and was diagnosed with terminal pancreatic cancer. At the time of the surgery, it was estimated that J.B. had six months to live. Dr. Roberto Cruz, J.B.'s doctor at Hialeah Hospital, recommended that the patient undergo chemotherapy; however, J.B.'s wife rejected that proposal. She did not want J.B. to know of the diagnosis. J.B. had told his family that if he had cancer, he would commit suicide. J.B.'s father and brother had had cancer, and the latter had committed suicide. J.B.'s wife and sister believed his threat to be sincere. Based upon the foregoing, J.B.'s wife implored J.B.'s doctors not to disclose his true condition. The families of J.B. and Respondent had been friends for many years going back to their common home in Central America. Respondent knew of J.B.'s diagnosis, and agreed to become his treating physician in November, 1987. Respondent did not tell J.B. of his true medical condition. Instead, Respondent let J.B. presume discomfort and other symptoms were the result of years of heavy drinking. In November, 1987, Respondent had been in private practice only a short time and was unfamiliar with office practices and billing procedures. Respondent did nothing to become familiar with billing practices, and relied on an employee who he mistakenly believed was competent to complete billing from the patient charts. When J.B. first presented at Respondent's office, he complained of abdominal pain. Further J.B. had discovered lumps which concerned him. To pacify J.B., Respondent suggested that a lymph node be removed and biopsied. J.B. and his wife discussed the removal of the lump and agreed that such removal would be appropriate. J.B. wanted to know that the lump was not cancer, and his wife wanted to know that the cancer had not spread or metastasized beyond the original sites. Respondent performed the lump removal in November, 1987, and billed J.B.'s medical insurance for same. At the time of this surgery Respondent was fully aware of J.B.'s medical condition, and knew that the procedure would not affect the medical condition, treatment, or life expectancy of the patient. The only medical result of the procedure was the uplifting of J.B.'s mental attitude since the lump was not cancer. In March, 1988, Respondent performed a colonoscopy with biopsy on J.B. This procedure was suggested as Respondent had presented with rectal bleeding, a symptom common in terminal cancer patients, and was desirous of some diagnosis as to the medical origin of the bleeding. Instead of advising J.B. that the bleeding could be consistent with the known medical condition, Respondent went ahead with the colonoscopy after less intrusive examinations did not establish the origin of the blood. At the time of the colonoscopy, Respondent knew that the procedure would not affect the medical condition, treatment, or life expectancy of the patient. Again, the only beneficial effect from the colonoscopy was an uplifting of J.B.'s mental attitude since the colonoscopy results, which were medically inconclusive, did not disclose cancer to J.B. Even if the colonoscopy had revealed some medical condition which could be treated, it would not have been medically necessary given J.B.'s other, overriding, condition. Anemia, a condition resulting from the loss of blood which is common in terminal cancer patients, could be treated without the colonoscopy procedure. Respondent did not refer J.B. to a psychiatrist for mental evaluation or confirmation as to the suicidal ideation but accepted J.B.'s wife's representations regarding his mental state. Respondent did not allege J.B. had expressed suicidal thoughts to him and did not report same in his medical notes. At all times material to the treatment of J.B., Respondent performed medical services through a company owned by his wife. This company, Sigma Medical Center, submitted bills for the services afforded J.B. on the standard billing forms known as "HCFA 1500." Respondent, as the treating physician, was required to sign all HCFA 1500 forms submitted regarding services for J.B. By executing the HCFA 1500 form Respondent certified that the information was correct and the procedures billed for were medically necessary and appropriate. In this case, Respondent has admitted that numerous billing errors occurred, that the HCFA 1500 forms were incorrect, and that an over-billing regarding services provided to J.B. resulted. For example, consultation visits are billed at a higher rate than regular office visits. Respondent routinely billed J.B.'s visits at the consultation rate even though there was no consultation to be given. Second, Respondent billed post-operative visits which should have been included in the surgical charges separately. Third, J.B. returned for office visits more frequently than would be expected because of the pain management Respondent employed. Because J.B.'s wife would not allow Respondent to prescribe any pain medications which J.B. might associate with cancer, he ended up taking quantities of other prescriptions to manage the pain and to return to Respondent frequently due to the unexplained (to him) reoccurrence of pain. Despite an admission that he reviewed the HCFA 1500 forms before signing them, Respondent maintains he did not, at the time, know that the billing was inaccurate. This assertion has not been deemed credible As to various tests ordered by Respondent for J.B., it is concluded that the following tests were medically unnecessary: the RPR test designed to detect syphilis infection (a STD was the least of this patient's worries), the FTA (a follow-up test to the RPR), and thyroid studies. Given the totality of the circumstances, Respondent's care and treatment of the patient, J.B., fell below the standard of care and skill which a reasonably prudent physician under similar circumstances and conditions would recognize as acceptable. As to DOAH case no. 94-0778 L.G. was an employee in Respondent's office. Unbeknown to Respondent, L.G. took samples of aerobid and proventil without a prescription for the drugs. An aerobid inhaler is used to control the symptoms of bronchial asthma. Proventil is also used to control bronchospasm which may be associated with asthma. L.G. took the samples with the intent that she would forward them to a relative in Cuba who suffers from asthma. L.G. had access to the samples. Respondent had never treated L.G. and there would have been no medical justification to dispense the samples to her. Although somewhat incredulous, Respondent's admission that he had dispensed the samples to L.G. was given, to his understanding, to end the investigation of the matter. He mistakenly believed that if he made the admission the matter would be closed. L.G.'s account as to the events of her removing the samples without Respondent's knowledge has been accepted. Nevertheless, the statement Respondent gave to the Department in connection with this incident was false.
Recommendation Based on the foregoing, it is, hereby, RECOMMENDED: That the Agency for Health Care Administration, Board of Medicine, enter a final order determining the Respondent violated Sections 458.331(1), (n) and (t), Florida Statutes, in the care provided to patient, J.B., suspending his license for a period of one year, placing him on probation for a period of two years thereafter, and imposing an administrative fine in the amount $10,000. DONE AND ORDERED in Tallahassee, Leon County, Florida, this 24th day of December, 1996. JOYOUS D. PARRISH Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 24th day of December, 1996. APPENDIX Rulings on the proposed findings of fact submitted by the Petitioner: Paragraphs 1 through 17, 19 through 39, 42 through 46, 48 through 52, 54 through 65, 69, 70, and 74 are accepted. Paragraph 18 would be rejected as contrary to the weight of the credible evidence IF J.B. had been sincerely suicidal; however, in this case Respondent did not refer J.B. to a psychiatrist, did not make an independent confirmation of J.B.'s mental state, and did nothing to which J.B.'s wife did not agree--therefore, it is impossible under the facts of this case to know whether or not J.B. should have been told. Under most circumstances, J.B. should have been told, and it is accepted that the care afforded to J.B. fell below the standard of care a reasonably prudent similar physician would have provided. Respondent's whole theory of this matter fails because Respondent never independently confirmed and had J.B. properly assessed, by a physician competent to make such assessment, as to whether this major hoax was appropriate. With all due respect to Dr. Blaustein, he merely relied on factual conclusions which are unsupported by medical records in this case. Paragraphs 40 and 41 are rejected as irrelevant because the examination was medically unnecessary regardless of how performed. Paragraph 47 is rejected as contrary to the weight of the credible evidence; this procedure, like others, was medically unnecessary and below the standard of care but its primary purpose was to pacify the patient and his wife regarding the rectal bleeding. Had Respondent been forthright this procedure would not have been performed. The overbilling for the procedure was for financial exploitation of the patient's insurance. Paragraph 53 is rejected as irrelevant because the studies were medically unnecessary anyway. Paragraphs 66 through 68 are rejected as irrelevant since the diagnosis would have always been subservient to the primary diagnosis and Respondent's services in this regard were medically unnecessary. Paragraph 71 is rejected as contrary to the weight of the evidence. L.G. was not Respondent's patient. L.G. stole the drugs and Respondent covered for her with the misguided idea that it would solve the problem and the investigation would be over. Paragraphs 72, 73, 75, 77, and 78 are all rejected since L.G. was not a patient they are irrelevant or contrary to the weight of the credible evidence. Rulings on the proposed findings of fact submitted by the Respondent: 1. Paragraphs 1 through 6, 8, 10, 11, 12, 18, 19, 22, 23, 24, 31, 32, 38 through 48, 51, 55 through 64, 68 through 74, 77, 81, 82, 84, 85, 86, 89 through 92, 100, 107 through 120, 122, and 123 are accepted. Paragraph 7 is rejected as speculation or irrelevant given the overriding issues of this case; further rejected as not credible. Paragraph 9 is rejected in part as contrary to the weight of the credible evidence as to the issue of money; otherwise, as to the families' long- standing friendship accepted. The credible evidence in this case supports the conclusion that Respondent was overpaid for unnecessary services until J.B.'s insurance ran out; that he did not require payment thereafter is irrelevant. It may also have been Respondent's motive for overcharging the insurance before it ran out. Paragraphs 13 through 17 are rejected as irrelevant or contrary to the weight of credible evidence. Respondent was not authorized to delegate the medical decisions regarding J.B.'s care to his wife or family. As the physician he was responsible, regardless of how difficult the situation, to either practice within the standard the care or refer the patient to a physician able to do so. Obviously, any physician would want to keep J.B. comfortable, that is why unpleasant procedures such as the colonoscopic examination were, in part, medically unnecessary. Respondent's highest obligation was to the patient not that person's family or their perceived (and uncorroborated by Respondent) notions as to the patient's mental state. Paragraph 20 is rejected as irrelevant. Paragraph 21 is rejected as contrary to the weight of credible evidence. Paragraphs 25 through 30 are rejected as irrelevant or contrary to the weight of the credible evidence. Paragraph 33 is rejected as contrary to the weight of credible evidence. Paragraphs 34 through 37 are rejected as irrelevant or contrary to the weight of the credible evidence. Paragraphs 49, 50, 52, 53, and 54 are rejected as irrelevant or contrary to the weight of the credible evidence. The fact that J.B. was encouraged by the false or meaningless services performed by Respondent does not justify the performance or billing for same. Respondent could have listed a textbook full of conditions which J.B. did not have to encourage him but it would not have been based on medical reality any more than the colonoscopy was. Lying to a patient to make him fell better and for financial gain is not acceptable practice. Paragraphs 65, 66, and 67 are rejected as irrelevant or contrary to the weight of the credible evidence. Paragraphs 75, 76, 78, 79, and 80 are rejected as irrelevant or contrary to the weight of the credible evidence. 13. Paragraphs 83, 87, 88, 93, 94, 95, 96, 97, 98, 99, 101, 102, 103, 104, and 105 are rejected as irrelevant or contrary to the weight of the credible evidence. Respondent was responsible for all insurance billing for Sigma Medical Center. Paragraph 106 is rejected as contrary to the weight of the evidence as to whether or not L.G. was a patient at the time of the incident complained of, or irrelevant if stating such relationship was at a prior time. Paragraph 121 is rejected as irrelevant. Paragraph 124 is rejected as contrary to the weight of credible evidence. COPIES FURNISHED: Hugh R. Brown Senior Attorney Agency for Health Care Administration Office of the General Counsel Post Office Box 14229 Tallahassee, Florida 32317-4229 Harold M. Braxton, Esquire Suite 400, One Datran Center 9100 South Dadeland Boulevard Miami, Florida 33156-7815 Dr. Marm Harris Executive Director Board of Medicine Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue The issue is whether, in his treatment of patient H.M., Dr. Sewell failed to practice medicine with the level of care, skill and treatment which is recognized by reasonably prudent, similar physicians as acceptable under similar conditions and circumstances.
Findings Of Fact Jesse Q. Sewell, III, M.D., is a licensed physician in the State of Florida, holding license ME0028694. He has been licensed for eleven years. On or about February 11, 1986, Dr. Sewell was the treating physician for H.M. When H.M. visited his office, Respondent performed a pelvic examination and concluded that the patient was not pregnant, and prescribed a legend drug for birth control, Ortho- Novum. No test was done to determine if H.M. was pregnant because Dr. Sewell regarded those tests as an unnecessary expense to the patient. Dr. Sewell did not instruct the patient to wait until her next menstrual period to begin to take the birth control pills. Rather, he told H.M. to discontinue the pills if she did not have a period by the time she finished the first packet of pills. At the time of the examination, the patient was already six to eight weeks pregnant. By failing to perform a urine or blood pregnancy test on February 11, 1986, the care rendered by Dr. Sewell fell below that level of care, skill and treatment recognized as appropriate by reasonably prudent physicians. Under proper care, a urine or blood pregnancy test would have been ordered and Dr. Sewell would have instructed the patient not to use the birth control pills until she had had a period. It is generally recognized that birth control pills should not be prescribed for anyone who is pregnant or suspected of being pregnant. Dr. Sewell relies on six articles from medical journals to demonstrate that there is no discernible risk to a woman or fetus when taking birth control pills prior to, during or after conception. These articles include: Smithells, R.W. (1981) "Oral Contraceptives and Birth Defects," 23 Journal of Developmental Medical Childhood Neurology at 369; Rothman, K.J., and Louik, C. (1978), "Oral Contraceptives and Birth Defects," 299 The New England Journal of Medicine, at 522; Harlap, S. and Eldor, J. (1980), "Births Following Oral Contraceptive Failures," 55 Journal of Obstetrics and Gynecology at 447; Savolainen, E., Saksela, E. and Saxen, L. (1981) "Teratogenic Hazards of Oral Contraceptives Analyzed in a National Malformation Register," 140 American Journal of Obstetrics and Gynecology at 521; Cuckle, H.S. and Wald, N.J. (1982), "Evidence against Oral Contraceptives as a Cause of Neural-Tube Defects," 89 British Journal of Obstetrics and Gynecology, at 547; Harlap, S., Shiono, P.H., and Ramcharan, S. (1985), "Congenital Abnormalities in the Offspring of Women Who Used Oral and Other Contraceptives Around the Time of Conception," 30 International Journal of Fertility at 39. Dr. Sewell's contention that the current medical literature indicates no statistically significant risk to a woman taking birth control pills prior to, during or after conception, is accepted. The deposition testimony of Dr. Edward J. Zelnick was entered by the Board of Medicine. Dr. Zelnick indicated that the failure to perform a blood or urine pregnancy test and starting the patient on birth control pills without testing to determine whether or not the patient was pregnant was imprudent practice, and fell below community standards. He went on to testify that Dr. Sewell's action did not constitute malpractice because it resulted in no injury. In determining whether or not the care rendered failed to meet community standards, it is not relevant that the patient was not harmed. A patient may be fortunate enough to suffer no ill effects even though the care provided was substandard. The issue is quality of the care, not the severity of any injury which may or may not result from inadequate care. Whether the patient suffered an injury, and if so, whether that injury was severe is an appropriate consideration in assessing any penalty for failure to practice medicine with that level of care and skill recognized as appropriate by similar physicians. The testimony of Dr. Zelnick that a pelvic examination was insufficient, that urine or blood pregnancy test should have been performed, and the patient should have been informed not to use the birth control pills until after a period, is persuasive. Even if no injury was caused, it is obviously useless for a physician to prescribe oral contraceptives for a patient who, already being pregnant, requires no protection against conception. Accordingly, a physician ought to determine whether the patient is pregnant before prescribing oral contraceptives.
Recommendation It is RECOMMENDED that Dr. Sewell be found to have violated Section 458.331(1)(t), Florida Statutes, that he be fined $250, placed on probation for three months, and required to complete three hours of continuing medical education in the prescription of legend drugs, including birth control drugs. DONE AND ORDERED this 20th day of October, 1987, in Tallahassee, Leon County, Florida. WILLIAM R. DORSEY Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 20th day of October, 1987. APPENDIX TO RECOMMENDED ORDER, CASE NO. 87-2567 The following are my rulings on the proposed findings of fact submitted by the parties pursuant to Section 120.59(2), Florida Statutes (1985). Rulings on Petitioner's Proposed Findings: Adopted in finding of fact 1. Adopted in finding of fact 2. Adopted in finding of fact 3. Adopted in findings of fact 5 and 7. Adopted in findings of fact 5 and 7. The gist of this finding is adopted in finding of fact 4 by stating the period of pregnancy as of the time of Dr. Sewell's examination and prescription of Ortho-Novum for the patient. Rulings on Respondent's Proposed Findings: The argument contained in Dr. Sewell's letter of September 28, 1987 is dealt with in finding of fact 6, adopting Dr. Sewell's argument that there is no statistically significant risk to a woman or her fetus in taking birth control pills prior to, during or after conception. Nonetheless, his actions constitute malpractice for the reasons stated in findings of fact 7 through 10. See also the Conclusions of Law. COPIES FURNISHED: Peter Fleitman, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Jesse Quimby Sewell, 111, M.D. 2855 Overseas Highway Marathon, Florida 33050 Ms. Dorothy Faircloth Executive Director Board of Medicine 130 North Monroe Street Tallahassee, Florida 32399-0750 Tom Gallagher, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 William O'Neil, Esquire General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
The Issue The issues in this case are whether Respondent violated Subsections 458.331(1)(m), 458.331(1)(t), and 458.331(1)(bb), Florida Statutes (2005),1 and, if so, what discipline should be imposed.
Findings Of Fact The Department is the State of Florida agency charged with regulating the practice of medicine in Florida pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes. At all times material to the Administrative Complaint, Dr. Labs was a licensed medical doctor within the State of Florida, having been issued license number ME 61579. Dr. Labs is certified by the American Board of Surgery and the American Board of Plastic Surgery. In April 2006, W.S. went to see Dr. Labs for a consultation. In the late 1980’s, W.S. had had breast implants placed by a physician in Texas. In 1995, another physician did a mastopexy to lift her breasts. W.S. wanted Dr. Labs to replace the breast implants that had been in place since the late 1980’s with smaller implants, to reduce the size of her breasts by excising tissue, and to lift the breasts with a mastopexy. She was under the impression that the implants which she currently had had been placed underneath the pectoral muscle, and she told Dr. Labs that she wanted to have the new, smaller implants also placed underneath the muscle, meaning subpectoral placement. Dr. Labs agreed to place the implants subpectorally. There are two ways that implants can be placed subpectorally. The first method involves placing the implant entirely under the muscle and then suturing the implant in place. There is very little migration of the implant with this method because the implant is tightly held by the muscle. The second method is called a dual-plane technique. In this method, a portion of the implant is placed under the pectoral muscle and a portion of the implant is covered by the glandular or lower part of the breast. Dr. Labs performed a bilateral reduction, mastopexy, and implant exchange on W.S. on April 25, 2006. His operative report described the procedure as follows: The patient was taken to the operating room after being marked in the standing position. She was placed in the supine position for smooth induction of anesthesia. Sequential compression boots were placed for DVT prophylaxis. The procedure began with de- epithelization of skin above each nipple for reinset. Scars were then excised around the nipple and from the vertical incision beneath the nipple to inframammary fold. Skin flaps were elevated and, then the central nipple pedicle preserved. Implants were removed, and breast tissue was excised laterally. The implants were then replaced with silicone implants after Betadine irrigation and surgical glove change. The removed implants were 220cc. The replaced implants were 175cc, and each breast was subjected to a 75 gram reduction. Towel clips were placed, and the patient was placed in the sitting position. Symmetry was excellent at the conclusion of the procedure. Multiplayer inset was then performed. The patient was placed in a sterile bulky dressing and Ace wrap. She returned to the recovery room in satisfactory condition, having tolerated the procedure well. Final sponge, needle and instrument counts were correct at the conclusion of the procedure. The patient was given explicit postoperative instructions for the care and maintenance of her wound and will be seen again in followup at the plastic surgery office. Dr. Labs took out the 220cc implants and placed 175cc implants in the same pocket where the 220cc implants had been placed. The 220cc implants which Dr. Labs removed had a small rim of the superior portion of the implants placed underneath the muscle. The remaining portion of the implants were subglandular. Dr. Labs placed the superior medial portion of the 175cc implants between .5 and 2.5 centimeters under the muscle, meaning that about ten percent of the implants were placed under the muscle. The remainder of the implants was subglandular. The method used by Dr. Labs was the dual-plane method and is considered to be a subpectoral placement. W.S. signed a consent form, which included an explanation of risks associated with open capsulectomy with breast implant exchange surgery. The risk of implant displacement was explained as follows: Displacement or migration of a breast implant may occur from its initial placement and can be accompanied by discomfort and/or distortion in breast shape. Difficult techniques of implant placement may increase the risk of displacement or migration. Additional surgery may be necessary to correct this problem. Subsequent to the surgery by Dr. Labs, W.S. began to experience problems with her breasts. The breasts were distorted, became an odd shape and stuck out more than her breasts had done with the implants placed by the Texas physician. Her breasts were bulging in the front and middle. W.S.’s breasts became uncomfortable, and W.S. was unable to lie on her stomach. The breasts did not look or feel natural; they were stiff, hard, and tight. The problems began to occur not long after the surgery; however, the distortion was not present until a month after the surgery. On December 6, 2006, W.S. visited Alexia Marciano, M.D., a board-certified plastic surgeon, for a consultation concerning the problems she was having with her breasts. On examination, Dr. Marciano noted that W.S. had pseudoptosis, which means there was some loose skin, but the nipple was still above the inframammary fold. Dr. Marciano observed that W.S.’s breasts were distorted, irregular in shape and position. There were capsular contractures, which are scar tissue that forms around the implants. The capsular contractures were a grade IV,2 which means that one could look at the breast and visually see the tightening. To Dr. Marciano, the implants appeared to be on top of the muscle, based on “the superficiality and the position of the implants in relation to the skin above and to the pectoralis muscle on the upper portion of the chest and on palpation.”3 W.S. advised Dr. Marciano that she wanted to have surgery to correct the problems she was having with her breasts and that she wanted to have smaller implants placed under the muscle. On January 19, 2007, Dr. Marciano performed a capsulectomy, which is moving the capsule or shell of the scar around the implant; an explantation of the silicone implants, which is removing the current implants; and an augmentation, which is putting in new implants. When Dr. Marciano made incisions in each breast to find the capsules, she found the capsules right beneath the subcutaneous tissue, which is basically right beneath the skin and above the pectoralis major muscle. Although Dr. Marciano found the implants which had been placed by Dr. Labs, above the major pectoralis muscle, she could not determine where the implants were actually placed by Dr. Labs at the time he performed the implant exchange on W.S. Dr. Marciano removed the silicone implants, identified the pectoralis muscle, incised the inferior edge of the pectoralis muscle, and dissected the plane underneath the muscle. Dr. Marciano placed new implants, which were 150cc’s, on both breasts. The new implants were placed entirely underneath the muscle, and the small opening that was made in muscle fascia was closed with sutures so that the implants were in a closed pocket. Capsular contraction, such as W.S. experienced, can cause the implants to move. Additionally, during the early stages after an implant has been placed, there is more potential for the implant to move before the capsule forms. Based on the evidence presented, the logical inference is that the capsular contraction caused the implants placed by Dr. Labs to move from underneath the pectoralis muscle so that the implants came to rest in a subglandular position as Dr. Marciano found them. There were no medical records admitted in evidence from the Texas physician who placed the original implants in the 1980’s. Based on what Dr. Labs found when he exchanged the implants, it is probable that the Texas physician used the dual- plane method to insert the implants, meaning that a portion of the implants were subglandular. This scenario comports with one of the hypotheses set forth by the Department’s expert, who surmised that, based on the preoperative photographs taken by Dr. Labs, it appeared that the Texas physician may have placed the original implants in a subglandular position rather than in a subpectoral position. If the Texas physician had used a dual- plane method and placed a small portion of the implants under the rim of the pectoralis muscle, then a large portion of the implants would appear to be placed in a subglandular position as surmised by the Department’s expert; when, in fact, the implants had been placed subpectorally as that term is commonly understood by plastic surgeons. Dual-plane placement also comports with W.S.’s distinct impression that the original implants had been placed under the muscle.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Dr. Labs did not violate Subsections 458.331(1)(m), 458.331(1)(t), or 456.072(1)(bb), Florida Statutes, and dismissing the Administrative Complaint. DONE AND ENTERED this 14th day of October, 2009, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 14th day of October, 2009.
The Issue The issues in these cases are whether Respondent violated Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes (2002), in DOAH Case No. 09-4678PL; Subsections 456.072(1)(l), 458.331(1)(m), and 458.331(1)(t), Florida Statutes (2003), in DOAH Case No. 09-4679PL; and Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes (2005), in DOAH Case No. 09-4680PL, and, if so, what discipline should be imposed.
Findings Of Fact At all times relating to the three Administrative Complaints at issue, Dr. Kachinas was a licensed medical doctor within the State of Florida, having been issued license number ME 65595. He is board-certified by the American Board of Obstetrics and Gynecology. DOAH CASE NO. 09-4678PL In 2002, Dr. Kachinas was working at several clinics that were owned by the same individual. He received payment from Sarasota Women’s Health Center and Tampa Women’s Health Center. His primary office was located in Sarasota, but he rotated through the offices located in Clearwater and Tampa. He was advised that he would be attending a patient in the Tampa office. One of the medications that he used in his method of sedating patients, Propofol, was not available in the Tampa office. He took a vial of the Propofol and took it to the Tampa office, holding the vial in his hand. While at the Tampa office, Dr. Kachinas drew the Propofol into a syringe. He did not have to use the Propofol for the patient. He placed the syringe filled with Propofol inside the sock that he was wearing. Dr. Kachinas transported the syringe back to the Tampa office. He used this method of transport so that the office manager in the Tampa office would not know that he was transporting the drug. When he got back to the Tampa office, he placed the filled syringe in a secure place. Propofol must be used within 24 hours after being drawn into a syringe. The next day it was decided that the drug would not be used on another patient, and Dr. Kachinas wasted the syringe filled with Propofol. At the clinics where Dr. Kachinas worked, there were no logs to keep track of the drugs, except for the drug Fentanyl. Dr. Kachinas acknowledged in a letter dated January 30, 2007, to the Department of Health that his method of transporting Propofol was “unorthodox.” In the same letter, Dr. Kachinas acknowledged that “a reasonable and prudent doctor would not generally transport medication in that manner, but foolishness seemed reasonable in that aberrant environment.” DOAH CASE NO. 09-4679PL On March 26, 2004, B.S. presented to Premier Institute for Women’s Health (Premier) for an elective termination of pregnancy. Dr. Kachinas was the physician who handled the procedure. Dr. Kachinas maintained records relating to B.S. at Premier. In 2004, Petitioner subpoenaed B.S.’s records from Dr. Kachinas’ office. Petitioner received a packet of documents, which purported to be B.S.’s medical records. In July 2006, Lori Jacobs, an employee of Premier, sent Petitioner another copy of the documents sent in 2004. Neither the records provided in 2004 nor the records provided in 2006 contain progress notes for B.S.’s treatment on March 26, 2004, and March 27, 2004. For the first time on November 5, 2009, Dr. Kachinas produced a three-page document, which he claimed was part of B.S.’s medical records that had been misplaced in B.S.’s insurance file. Two of the pages purported to be progress notes for March 26 and 27, 2004. The third page, which is also labeled as a progress note, is dated June 29, 2004, and appears to relate to insurance claims. The two pages relating to March 26 and 27 are on paper which is a different color from the progress note relating to insurance claims and the progress notes which were previously furnished in 2004 and 2006.1 Additionally, the progress notes for March 26 and 27, 2004, contain a break in each of the ruled lines on the sheets on both the right and left sides of the sheets. The insurance progress note and the progress notes furnished in 2004 and 2006 do not have such breaks in the ruled lines. Dr. Kachinas completed a Laminaria Insertion report documenting procedures done on March 26, 2004, and March 27, 2004. The March 26, 2004, report documents the insertion of Laminaria and administration of medications. The comment section of the report documents the removal of the Laminaria and administration of medications on March 27, 2004. The comment section continues to document the administration of medications and the taking of vital signs after the removal of the Laminaria and also the transfer of the patient to Doctors Hospital. The detail on the comment sections suggests that Dr. Kachinas was making his progress notes in the Laminaria Insertion report. The failure to produce the purported progress notes for March 26 and 27, 2004, until November 5, 2009; the difference in the color of the paper of the March 26 and 27, 2004, purported progress notes and the other progress notes in Dr. Kachinas’ records; the presence of breaks in the ruled lines on the March 26 and 27, 2004, purported progress reports, which do not appear on the other progress notes; and the detail of the comments on the Laminaria Insertion report support the conclusion that the progress notes submitted as Respondent’s Exhibit 1 were not done contemporaneously with the treatment given to B.S. on March 26 and 27, 2004, but were prepared for this proceeding. Thus, the progress notes for March 26 and 27, 2004, are not credited. Dr. Kachinas determined B.S.’s pregnancy to be at approximately 23½-to-24 weeks’ gestation, the last week of the second trimester. He confirmed by sonogram that the gestation period was 24 weeks. On March 26, 2004, Dr. Kachinas began the induction of labor ordering the insertion of ten Laminaria, which are osomotic cervical dilators which cause the cervix to open and allow easier emptying of the uterus. Dr. Kachinas’ records do not show that B.S.’s medical history was taken prior to the insertion of the Laminaria. However, Dr. Kachinas did take a medical history of B.S. at the time of her admission to Doctors Hospital, and the history is recorded in the medical records. Prior to the insertion of the Laminaria, Dr. Kachinas’ records do show that a limited physical examination of B.S. was done. The Laminaria Insertion report shows that B.S.’s baseline blood pressure, temperature, and pulse were taken and recorded. There was no expert testimony of what other physical examination should have been done. Dr. Kachinas injected the fetus with Digoxin, which is injected directly into the fetus to stop the fetal heartbeat, causing an Intrauterine Fetal Demise (IUFD). The injection of the Digoxin was not documented in B.S.’s medical records. B.S. was then released from Premier. On March 27, 2004, B.S. returned to Premier. Prior to removing the Laminaria, Dr. Kachinas did an ultrasound and determined that there was still fetal heart activity and fetal movements. Dr. Kachinas continued the labor induction procedure by removing the Laminaria and administering Cytotec and high dosages of Pitocin. When the Laminaria were removed, there was a rupture of membranes with a loss of essentially all the amniotic fluid. Sometime during the afternoon of March 27, 2004, Dr. Kachinas did another ultrasound and determined that there was no fetal heart activity. Based on the length of time from the Digoxin injection to the ultrasound showing no fetal heart activity, the loss of amniotic fluid, and the administering of medication to cause contractions, Dr. Kachinas determined that the Digoxin injection was not the cause of death. On March 27, 2004, at approximately 6:30 p.m., Dr. Kachinas transferred B.S. to Doctors Hospital and had her admitted to the hospital for failure to progress with the induction of labor procedure. While at the hospital, B.S. continued to experience pain. On March 28, 2004, Dr. Kachinas performed the following procedures on B.S.: mini-laparotomy, hysterotomy, removal of products of conception, and a modified Pomeroy bilateral tubal ligation. In his description of the procedures, he stated that the fetal demise was at least of 48 hours duration. However, Dr. Kachinas’ records do not reflect the time of the fetal demise. Jorge Gomez, M.D., Petitioner’s expert witness, credibly testified that a physician is required to document the time of the fetal demise. In the hospital records following B.S.’s surgery, Dr. Kachinas listed the post-operative diagnosis as a failure to induce labor, an intrauterine fetal demise, a thin umbilical cord, and asymmetric intrauterine growth retardation, a condition in which the fetus is smaller than expected for the number of weeks of pregnancy. An autopsy was performed on the fetus. A surgical pathology report was also issued. The pathology report showed mild infarcts on the maternal side. On the fetal death certificate, Dr. Kachinas listed the immediate causes for the IUFD as a possible cord incident and multiple placental infarctions. Dr. Kachinas did not document the elective termination or the Digoxin injection on the fetal death certificate. Dr. Gomez disagrees with the reasons for IUFD given on the death certificate. His credible reading of the pathology report does not indicate that the infarcts were severe enough to have contributed to the fetal demise. His credible reading of the pathology report does not indicate that there was any evidence of a cord incident. Dr. Gomez is of the opinion that the cause of death should have been listed as elective termination. Dr. Gomez’ opinion is credited. However, Dr. Gomez did not give an opinion on whether the fetal demise was caused by the injection of Digoxin. DOAH CASE NO. 09-4680PL On December 13, 2005, K.M. was seen by Walter J. Morales, M.D., at Florida Perinatal Associates, which specializes in internal fetal medicine. Dr. Morales performed an ultrasound on K.M., who was pregnant with twins as a result of in vitro fertilization. The ultrasound revealed that the twins were fraternal, meaning that each twin had a separate placenta and a separate sac. One of the twins, Twin A, had an anomaly called a cystic hygroma, which results from an obstruction, causing the lymphatic fluid, which normally drains into the juglar vein, to accumulate in the neck area. Approximately 50 percent of the fetuses which have this anomaly in the first trimester also have a chromosomal anomaly, such as Down syndrome. The decision was made to have K.M. return to Florida Perinatal Associates in three weeks for further evaluation. On January 3, 2006, Edgard Ramos-Santos, M.D., a partner of Dr. Morales, performed another ultrasound on K.M. Dr. Ramos-Santos found that Twin A, a male, had a cystic hydroma, a thickening of the nuchal fold2, and shortened femur and humerus. These findings are soft markers for abnormal chromosomes. The ultrasound also revealed a possible heart defect. At the time of the ultrasound, Twin A was cephalic bottom, meaning that Twin A was positioned lowest in the uterus. Dr. Ramos-Santos also performed an amniocentesis on Twin A on the same date as the ultrasound. The amniocentesis showed that Twin A had an abnormal chromosome pattern compatible with trisomy 21 or Down syndrome. Both ultrasounds showed that Twin B, a female, appeared to be normal. At the request of K.M., no amniocentesis was performed on Twin B on January 3, 2006. At the time of the ultrasound performed on January 3, 2006, the presentation of Twin B was cephalic right. The findings of the January 3, 2006, ultrasound were discussed with K.M. and her husband. On January 9, 2006, Dr. Ramos-Santos discussed the results of the amniocentesis with K.M.’s husband. It was decided that a selective feticide would be performed on Twin A. Selective feticide is a procedure in which a solution of potassium hydroxide is injected into the fetus’ heart to make the heart stop beating. K.M. was referred to Dr. Kachinas at Premier for the selective feticide. On January 10, 2006, Roberta Bruce, a nurse at Florida Perinatal Associates, sent to Premier by facsimile transmission the January 3, 2006, ultrasound report for K.M. and K.M.’s insurance information. The cover page for the facsimile transmission included a note from Ms. Bruce, which stated: “* FYI Fetus have different gender. The male is the affected one.” The standard of care as specified in Section 766.102, Florida Statutes (2005), requires a physician performing a selective feticide to correctly identify the affected fetus. Dr. Kachinas did not correctly identify Twin A prior to performing the selective feticide and performed the procedure on Twin B, the normal fetus. Dr. Kachinas performed an ultrasound on K.M., but failed to identify the correct position of Twin A in relation to K.M. The ultrasound done on January 3, 2006, by Dr. Ramos-Santos showed that Twin A was located at the bottom and Twin B was located to the right of K.M. In his progress notes, Dr. Kachinas placed Twin A on the right and Twin B on the left. Although it is possible for twins to shift positions, it is not probable that the twins shifted from left to right. Dr. Kachinas performed an ultrasound, but failed to identify that Twin A was the fetus with multiple anomalies. Although the standard of care required Dr. Kachinas to do a Level 2 ultrasound evaluation, a Level 1 ultrasound evaluation would have identified the cystic hygroma, the shortened long bones, and the sex of Twin A. Dr. Kachinas failed to perform an adequate ultrasound evaluation by failing to identify the anomalies and the gender of Twin A. Dr. Kachinas’ notes do not show whether Twin A or Twin B had anomalies. His notes did not identify the sex of each of the twins. His notes did not document the attempts that Dr. Kachinas made to identify the anomalies such as a recording of the length of the long bones or any examination made to identify the sex of each of the twins. On January 24, 2006, K.M. returned to Florida Perinatal Associates for another consultation. Dr. Morales performed another ultrasound, which revealed that Twin A, who had the anomalies, was still viable. The ultrasound revealed the continued presence of a cystic hygroma, the thickening of the nuchal fold, shortened extremities, and a congenital heart defect. The ultrasound also showed that the viable twin was male. The presentation of Twin A was shown by the ultrasound as cephalic bottom.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED as to DOAH Case No. 09-4678PL that a final order be entered finding that Dr. Kachinas violated Subsection 458.331(1)(t), Florida Statutes (2002), by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent physician as being acceptable under similar conditions and circumstances; finding that Dr. Kachinas did not violate Subsection 458.331(1)(m), Florida Statutes (2002); imposing an administrative fine of $2,500; and placing Dr. Kachinas on probation for one year. Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED as to DOAH Case No. 09-4679PL that a final order be entered finding that Dr. Kachinas did not violate Subsections 456.072(1)(l) and 458.331(1)(t), Florida Statutes (2003); finding that Dr. Kachinas violated Subsection 458.331(1)(m), Florida Statutes (2003); imposing an administrative fine of $1,000; and placing Dr. Kachinas on probation for one year. Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED as to DOAH Case No. 09-4680PL that a final order be entered finding that Dr. Kachinas violated Subsection 458.331(1)(t), Florida Statutes (2005), by committing gross medical malpractice; finding that Dr. Kachinas violated Subsection 458.331(1)(m), Florida Statutes (2005); imposing an administrative fine of $2,000 and placing him on probation for one year for the violation of Subsection 458.331(1)(m), Florida Statutes (2005); and revoking his license for the violation of Subsection 458.331(1)(t), Florida Statutes (2005). DONE AND ENTERED this 26th day of January, 2010, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 26th day of January, 2010.
