The Issue The issue to be resolved in this proceeding concerns whether the Respondent's medical licensure should be subjected to discipline for the reasons asserted in the Administrative Complaint, involving his alleged malpractice concerning patient, E.L.
Findings Of Fact The Respondent at all times material hereto has been a licensed physician in the State of Florida, having been issued License No. ME0030859. The Respondent practices at 1800 N.E. Street, Suite 521, Pensacola, Florida 32501. The Petitioner is an agency of the State of Florida. It is charged by the Legislature, as pertinent hereto, with enforcing the provisions of Chapter 458, Florida Statutes, and related rules, pertaining to the regulation of licensure and the quality of practice of medical doctors within the State of Florida. The Respondent is a board-certified dermatologist, practicing that specialty in the State of Florida in excess of 15 years. There is no evidence of any prior disciplinary action against the Respondent's licensure nor of any prior instance when his practice failed to conform to appropriate professional standards. In the course of his practice, the Respondent sometimes does his own microscopic pathological examination of tissue samples taken from patients (biopsies) on occasions when he deems it appropriate and that a consulting opinion is not required. It is undisputed by the parties that a dermatologist such as the Respondent, who had extensive training in dermatopathology during his medical education, can appropriately do such biopsy work within the standard of care of a reasonable physician practicing under similar conditions and circumstances. If he does so, however, he is held to the standard of a dermatopathologist in the course of his professional practice. The Respondent treated E.L. (an 80-year-old male patient at times pertinent hereto) since approximately 1982 for various problems involving pathology of the skin, including skin carcinoma. On November 21, 1991, E.L. presented as a patient of the Respondent showing a crusty area measuring approximately 1 x 2 centimeters on the vertex of his scalp or the back of his head. The lesion in question appeared on the skin with a hard crust, whitish or yellowish in color, and the Respondent diagnosed it as hypertrophic actinic keratosis. This is sometimes a pre-cancerous condition of the skin. Upon making his diagnosis, which he did clinically, without biopsy, the Respondent performed a curettage, or scraping of the tissue, to remove and destroy it. He did this by injecting the area with lidocaine as an anesthetic before performing the curettage. The Respondent had previously treated the same sort of condition on E.L. with liquid nitrogen but chose, this time, to treat the lesion with extension cautery and curettage. He did this because he was attempting to lessen the discomfort in his 80-year-old patient, who had already undergone a number of procedures to remove pre-cancerous or cancerous lesions of the skin on his head. The use of liquid nitrogen and the associated burning of the tissues involved would cause more difficult healing and discomfort for the patient. The treatment which the Respondent accorded the actinic keratosis condition, by curettage, is an acceptable, appropriate treatment for such a condition. It is undisputed by either the Petitioner's or the Respondent's expert witnesses, as well as the Respondent in his testimony, that such a clinical diagnosis and the following treatment by curettage is within the professional standard of care and practice by dermatologists practicing under similar conditions and circumstances. A biopsy is not a necessary prerequisite to such treatment. After the November 21, 1991 destruction of the skin lesion, the patient did not return for approximately one month. On December 19, 1991, he returned to the Respondent concerned about possible infection at the removal site. The Respondent, however, detected only granulation tissue, which are normal granular projections on the surface of a normally-healing wound. Consequently, there was no reason within the bounds of reasonable medical treatment standards for the Respondent to have biopsied the lesion area on that office visit occasion, either. Patient E.L. returned on January 3, 1992, at which point the Respondent noted a minor area of "dermatitis" or a non-cancerous inflammation of the skin, for which he prescribed a cortisone ointment. The Respondent did no biopsy at that time, either, and the clear and convincing evidence does not demonstrate that a biopsy was required under those conditions and circumstances within acceptable, reasonable bounds of the Respondent's professional practice. Patient E.L. returned to the Respondent on January 23, 1992 complaining of unsatisfactory progress with the healing of the lesion. The lesion by that time had become a rounded, raised growth with central cratering, characteristic of a keratoacanthoma. The Respondent examined the lesion or tumor clinically and determined that it appeared to be a keratoacanthoma. A keratoacanthoma is a rapidly-growing nodule with a central "crater", which then fills with a crusty material. It usually remains localized and most often resolves itself spontaneously, even if untreated. On very rare occasions does it become an aggressively-growing tumor. The Respondent biopsied the suspected keratoacanthoma by performing an excision of the area. He excised the nodule, taking a narrow margin of several millimeters around it and then performed a suture closure of the wound. He performed a biopsy of the tissue thus taken himself and interpreted the biopsy results approximately one week later as confirming his clinical diagnosis of a keratoacanthoma. Keratoacanthoma is regarded as a "low-grade" form of squamous cell carcinoma. The diagnosis is based upon a clinical observation with the naked eye, based upon history, as well as by pathological diagnosis. Conservative treatment is appropriate for a keratoacanthoma since they often resolve themselves spontaneously. Simple observation, surgical excision, curettage with or without electro-desiccation, radiation therapy, intra-lesional injection, and topical application of 5-fluorouracil and methotrexate are all acceptable forms of treatment for keratoacanthoma and can be reasonably expected to cure the condition. On rare occasions, keratoacanthoma can recur, even with such treatment. The diagnosis and treatment of keratoacanthoma is a matter of good- faith differences of opinion among reasonable dermatologists and pathologists, based upon their clinical judgment and experience. Some diagnose it as keratoacanthoma, which is a low-grade form of squamous cell carcinoma; and some diagnose it as squamous cell carcinoma with varying degrees of "differentiation". The photograph of the lesion as it was seen by the Respondent prior to the January 23, 1992 surgery shows a lesion consistent with the clinical appearance of a keratoacanthoma. The Respondent has been properly trained as a dermatologist in dermatopathology, and he commonly reviews biopsy and pathology slides. He is not required, under pertinent practice standards, to seek consultation when he believes that he has made a proper diagnosis. It was proper for him to read and review the pathology slide of the biopsy specimen, even though he himself acknowledges, as do the two expert witnesses, that he would be held to a dermatopathologist's professional practice standard by doing so. The Respondent opined that actinic keratosis developed into the keratoacanthoma. Dr. Breza, the Petitioner's expert witness, opined that actinic keratosis does not develop into keratoacanthoma but, rather, into squamous cell carcinoma. Even he acknowledged, however, that good pathologists have trouble making the diagnosis of keratoacanthoma and prefer generally to diagnosis such conditions as simply "low-grade" squamous cell carcinoma. Dr. Hanke, in his testimony, established that keratoacanthoma and squamous cell carcinoma are different gradients of diagnosis on the same continuum or range describing squamous cell carcinoma. That is, in lay terms, a keratoacanthoma is a "low-grade" squamous cell carcinoma. They are not precisely the same diagnosis, but both diagnoses describe the same general type of cells. As shown by Dr. Breza, squamous cell carcinoma tumors or lesions generally tend to appear somewhat flatter than that characteristic of a keratoacanthoma. Squamous cell carcinomas tend to be more indurated or firm on the outer edges and to have more inflammation on the outer edges, including occasional ulceration. The Respondent's description in E.L.'s medical record seems more consistent with squamous cell carcinoma, but the photographic images of the growth or lesion at issue, made at the time the biopsy and excision was performed, appear also consistent with keratoacanthoma. Based upon the information, including clinical appearance, that the Respondent had to consider in making his diagnosis and given that reasonable pathologists can differ concerning the gradients of diagnosis of squamous cell carcinoma (which includes keratoacanthoma), as shown by the expert testimony, the Respondent's diagnosis does not constitute a departure from appropriate, professional standards. The deficiency in the Respondent's practice in this instance began with the excision made on January 23, 1992. The Respondent took the tissue material from the excision for biopsy and, after pathological examination of the sample, diagnosed the nodule as keratoacanthoma. The Respondent, however, did not establish a "negative margin" for the excision. That is, the tissue removed had positive margins, especially the deep margin, which means that carcinoma cells could be observed on the surface of the piece of tissue removed. This means that the Respondent could not be assured that carcinoma cells did not remain in the tissue area surrounding the walls of the excision site because the margin of the excision around the nodule to be removed was not wide enough. The same slide and tissue sample which the Respondent used for biopsy in January 1992 was examined by a dermatopathologist, but not until some six months later, in July 1992. The dermatopathologist reported his opinion that the biopsy showed an "infiltrating squamous cell carcinoma with involvement of the lateral and deep margins." An infiltrating carcinoma implies that it is a more aggressive tumor than would be the case with a normal keratoacanthoma. The Respondent did not report those positive margins from the results of his excision and biopsy in January 1992. His testimony indicates that he may have seen them or been aware of them but did not make a larger incision in order to achieve a negative margin because of his concern about the complicated closure techniques that would be necessary. He was concerned with attendant additional discomfort to this elderly patient, as might be entailed with the possible use of grafting in order to make closure of the wound. He also seemed to discount the need to excise a larger margin because of his belief that he was dealing with a non-aggressive keratoacanthoma. In fact, however, the clear and convincing evidence shows that a larger margin wound could have been excised without the necessity for more elaborate techniques of closure and attendant discomfort to the patient. Moreover, it was established that even this elderly patient, with his attendant heart problems, could have tolerated a more elaborate excision of the tumor in question, since the procedure could still be done under low-risk local anesthesia in the Respondent's office. An infiltrating carcinoma is one which is more aggressive. It can move from its original location and infiltrate the skin and blood vessels, which can, in some cases, result in the tumor spreading via the blood stream or by infiltrating the lymphatic system, with migration to regional lymph nodes. The squamous cell carcinoma is not known for being a readily metastasizing form of cancer. It is known on some occasions to metastasize, however. The finding of positive margins on the pathological examination in July 1992 means that the tumor extended to the cut surface of the excision at the time of the January excision procedure from which that biopsy sample was taken. Thus, tumor cells remained in the patient's scalp after the January 1992 excision procedure. The finding of a positive margin requires that another margin be established, meaning that the physician must cut another level of tissue until normal skin (a negative margin) is revealed. This can be done by conventional surgery, by just a larger excision area being removed, or by "MOHS" surgery, which involves freezing sections of the excision area, with small portions of the suspicious area removed at a time and with attendant pathology examinations so that each "thread" of cancer cells can be removed with minimal damage to surrounding tissues and less attendant discomfort and healing problems associated with the resulting surgical wound. The patient could have tolerated either type of procedure in January 1992. The Respondent did not establish a negative margin, however. He only excised the carcinoma once. He stated that he was really seeking only a biopsy sample and that he considered the treatment by excision of the nodule itself and attendant scraping of the wound to be adequate as conservative treatment, to take care of what he believed to be a non-aggressive keratoacanthoma. This may be a correct assessment if the physician is certain that he is confronted with a non-aggressive, non-infiltrating keratoacanthoma. However, if positive margins to the excisional wound result, the patient is better served, and a successful treatment result much more likely, if all suspected carcinoma cells are removed at that time. If the Respondent knew of the positive margins to the excision and had made an additional excision to remove all positive margins, the provision of additional, more elaborate treatment techniques would not have been delayed for nearly six months and likely would have been unnecessary. The determination of the existence of positive margins, after the January 1992 excision procedure, should have caused him to remove additional tissue to obtain a safe, negative margin. That failure of care, in his capacity as a dermatopathologist, resulted in a six-month delay before the dermatopathologist, at Sacred Heart Hospital, identified the positive margins. He identified them on the Respondent's same January 1992 pathological slide, when he examined it in July 1992, after which radiation and further more radical treatment was attempted. Thus, the delay in treatment action, resulting from the delay in acting on the existence of positive margins by the Respondent, resulted in a six-month delay in appropriate treatment being provided the patient, which is a deviation from the accepted standard of care, as established by the testimony of Dr. Breza, which is accepted in this regard. Earlier determination (or acting on a determination) of the positive margins, after the January 1992 excision procedure would have alerted the Respondent that the excision procedure was unsuccessful and that further treatment was necessary. The patient's lesion occurred on a sun-damaged scalp. The Respondent had treated the patient repeatedly for sun-damaged skin problems, including carcinomas, in the past. Squamous cell carcinomas can be susceptible to mestastases, either regional or systemic when they are located on the scalp, although they are much less susceptible to such mestastases than if they are located on the lip or possibly the dorsal surface of the hand. The Respondent, as a board-certified dermatologist, knew or should have known that the scalp is an area of the body that can be susceptible to metastatic disease such as squamous cell carcinoma. The patient, as even acknowledged by the Respondent's expert, Dr. Hanke, was one with a high risk for developing skin cancer. In any event, after the excision procedure on January 23, 1992, the patient was seen on February 10, 1992 for removal of sutures and examination of the wound. It appeared to be healing nicely at the time, and the patient was advised to return to the Respondent in three months, unless a problem developed. The Respondent next saw the patient on April 6, 1992, when he complained of persistent pain at the excision and tumor site. This was treated by the Respondent by drainage, antibiotics, narcotic pain medications, and sleep- inducers. Later during the treatment regimen, in approximately May 1992, the Respondent felt that chemotherapy was indicated because apparently, the lesion had not been completely excised. Consequently, he prescribed injections of intralesional cortisone methotrexate and 5-fluorouracil. These, however, did not produce satisfactory healing or control of the pain. During April and May 1992, the Respondent saw the patient for complaints of persistent pain, poor healing, and drainage of the wound. On May 18, 1992, the Respondent performed a drainage of the lesion which had begun to show an abscess formation. An abscess formation is an indicator of squamous cell carcinoma, which should have been recognized by the Respondent. This should have alerted him that his diagnosis of simply keratoacanthoma was not correct, at least by that time. With the presence of these continuing and exacerbated problems with the wound site, the Respondent did not seek or perform further biopsy of the tumor site, despite continued complaints of persistent pain and further growth of the lesion between April and July 1992. The patient made 16 visits to the Respondent between April 1992 and July 14, 1992 for treatment and pain relief. During this time, little improvement occurred in the patient's condition, but no additional biopsy or consultation was requested or performed by the Respondent. The lack of improvement in E.L.'s condition during the period of April through July 1992 should have alerted the Respondent that something was incorrect about the patient's condition and that more extensive radical treatment would be necessary. In fact, the Respondent did respond to the continued complaints by, in addition to prescribing antibiotics and pain medication, prescribing the above- referenced intralesional injections of cortisone, methotrexate, and 5- fluorouracil. On July 9, 1992, another curettage procedure was performed and the pathology of the scrapings was sent for evaluation by a pathologist. The Respondent's interpretation of this tissue at the time apparently was a keratoacanthoma; well-differentiated squamous cell carcinoma. This was ultimately described by the pathologist to whom it was referred as a moderately- differentiated squamous cell carcinoma. Subsequently, after the C&D procedure, the patient was referred to Baptist Hospital in Pensacola, Florida, for radiation therapy. He received a full-course of radiation therapy with some booster therapy afterward and then, on his own volition, went for a second opinion to the University of South Alabama Medical Center in Mobile, Alabama. Five physicians at that facility recommended more extensive surgery, which ultimately the patient refused. There is no clear and convincing evidence that, at least at that point in the patient's progress, the persistent tumor had actually mestastized, although it was apparently growing locally. The fact that the lesion at issue was failing to heal and producing persistent pain by the visit of April 6, 1992 should have been interpreted so as to set in motion further investigative procedures, including an additional biopsy, to find out the reason for that condition and its persistence. Although a proper procedure involving excision and biopsy was done in January of 1992, the frozen sections of the lesion could have been interpreted to show that the tumor was an infiltrating carcinoma extending to the lateral and deep margins of the excision and something more aggressive could have been done to treat it at that time. It could have either been re-excised with frozen section control of the margins, referred to a "MOHS'" surgeon for a similar type of surgery or referred to a general surgeon. Radiation therapy could have been tried, at least by the time the persistence of the problem was determinable in April of 1992. The resultant reduction of delay in securing more extensive treatment of the lesion would have certainly benefited the patient. The persistence of the pain in the six-month period of time after the January 1992 excision of the tumor, until just before the time the patient was referred for radiation therapy indicates there was probably perineural invasion by the tumor (infiltration of the nerves), which produced pain. This should have alerted the Respondent that something more than a non-aggressive keratoacanthoma was involved, as well. In summary, it has been demonstrated that the Respondent failed to practice medicine within that level of care, skill and treatment recognized by reasonably prudent, similarly-situated physicians as acceptable under the circumstances, by failing to make an additional biopsy after the patient re- presented with problems associated with persistent pain and improper healing in April 1992; by failing to recognize and act on the presence of positive margins to the excision material taken in January 1992, to effect an additional excision at that time, so as to secure a safe, negative margin to the tumor. The failure to obtain consultation on the biopsy taken from a dermatopathologist was not in itself evidence of falling below appropriate professional levels of care, skill and treatment, but the Respondent, by doing his own interpretation of the biopsies was, as he agrees, creating a situation in which he would be held to the same standard as a dermatopathologist. The failure to correctly interpret the biopsy he took in January 1992, by failing to recognize the positive margins to the excised material and failing to act to remove those indicia of the continued presence of the tumor, at a time when it was thus easily excised, likely prevented an easily-effected cure.
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence of record, the candor and demeanor of the witnesses, and the pleadings and arguments of the parties, it is RECOMMENDED that the Respondent be found guilty of a violation of Section 458.331(1)(t), Florida Statutes, in the manner concluded above, and that the Respondent receive a private reprimand, a $2,000.00 fine, and that he be required to attend 20 additional hours of Category I continuing medical education in the area of diagnosis and treatment of skin cancer. DONE AND ENTERED this 30th day of October, 1995, in Tallahassee, Florida. P. MICHAEL RUFF, 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 30th day of October, 1995. APPENDIX TO RECOMMENDED ORDER, CASE NO. 94-3531 Petitioner's Proposed Findings of Fact 1-8. Accepted. 9-10. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. Accepted, but not itself materially dispositive. Rejected, as contrary to the clear and convincing evidence. The evidence does not reflect that one biopsy sample only showed one part of the lesion at issue but, rather, several parts were represented. Accepted. Accepted, but not itself materially dispositive. 15-21. Accepted. 22-24. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 25-26. Accepted. 27. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 28-36. Accepted. 37-41. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 42-44. Accepted. 45. Rejected, as contrary to the clear and convincing evidence and subordinate to the Hearing Officer's findings of fact on this subject matter. 46-53. Accepted, but not in their entirety materially dispositive. 54. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 55-56. Accepted. Rejected, as not in its entirety supported by clear and convincing evidence of record. Accepted. Accepted, to the extent of failing to practice medicine within the appropriate standard of care by not making earlier and more frequent biopsies only. Respondent's Proposed Findings of Fact 1-17. Accepted. 18. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 19-20. Accepted. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter, and as not entirely in accord with the clear and convincing evidence of record. Accepted. Accepted, but not necessarily as to its material import and subordinate to the Hearing Officer's findings of fact on this subject matter, which contain additional findings of fact not contained in Proposed Finding of Fact No. 23 and which are material, relevant, and necessary to a clear picture of the patient's progress and treatment rendered during the period of April 6, 1992 through July 14, 1992. Accepted, but not as to its purported material import. Rejected, as contrary to the clear and convincing evidence of record, and as subordinate to the Hearing Officer's findings of fact on this subject matter. Accepted, but not as to its purported material import. 27-31. Accepted. COPIES FURNISHED: Britt Thomas, Senior Attorney Mary Anne Davies, Certified Legal Extern Agency for Health Care Administration 1940 North Monroe St., Ste. 60 Tallahassee, FL 32399-0792 Donald Partington, Esq. CLARK, PARTINGTON, ET AL. Post Office Box 13010 Pensacola, FL 32591-3010 Dr. Marm Harris Executive Director Board of Medicine Agency for Health Care Administration 1940 North Monroe Street Tallahassee, FL 32399-0770 Jerome W. Hoffman, Esq. General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, FL 32309
The Issue The issue in this case is whether the license of Allen B. Erde, M.D., should be disciplined by the Florida Board of Medicine based upon actions he is alleged to have taken, or failed to have taken, between August and November, 1986, in the care and treatment of his patient, C.W.
Findings Of Fact At all times material hereto, Respondent has been licensed as a physician in the State Of Florida, having been issued license number ME-0008625. Respondent was C.W.'s obstetrician during her pregnancy in 1986, and initially examined her on August 26, 1986, when she was six weeks pregnant. During this initial visit, C.W. was informed by Respondent that her pregnancy was progressing normally. At her second visit, on September 23, 1986, Respondent detected no fetal heartbeat. However, he informed C.W. that this was not a problem. He requested that she bring her husband with her for her third visit so that they both could hear the heartbeat. Prior to her third visit, C.W. saw Respondent in his office on October 6, 1986, complaining of urinary problems, and a stiff neck and back. Respondent treated her for a urinary tract infection. Later that same day she began to bleed vaginally, passed clots and experienced cramping pains. She then saw Respondent at the Winter Haven Hospital emergency room, but was told that nothing seemed wrong. Respondent advised her simply to go home, put her feet up, and rest. There were several other occasions during October, 1986, when C.W. experienced cramping and vaginal bleeding. She called Respondent each time to express her concerns, but was told simply to lie down, and keep her feet up. On October 22, 1986, C.W. and her husband visited Respondent for her third scheduled visit. No heartbeat was heard. Respondent again told C.W. that there was no cause for concern, the baby was just small and probably behind her pelvic bone. C.W. was presumably 14 weeks pregnant at this time, but Respondent's office records indicate that the fetus was decreasing in size, there was no weight gain, and no heartone. C.W. continued to experience pain and bleeding, sometimes accompanied by clots. She was not gaining weight, and had none of the other indications of pregnancy which she had experienced in her prior pregnancies. C.W. continued to express concern to Respondent, but his advice remained simply to lie down, and keep her feet up. In response to a five day episode of bleeding, C.W. saw Respondent in his office on November 12, 1986. Although she was 17 weeks pregnant at that time, Respondent's office records indicate a fetus 14 weeks in size. Respondent did not order any fetal viability tests, and there is no evidence in his office record that he considered any testing of the fetus. C.W. saw Respondent for her fourth scheduled visit on November 19, 1986, and, again, no fetal heartbeat was detected. She was still experiencing vaginal bleeding. Her uterus was only 10-12 weeks in size, although she was presumably 19 weeks pregnant at this time. C.W. was distraught, and expressed great concern to Respondent that she was presumably almost five months pregnant and no fetal heartbeat had ever been detected. C.W. demanded that Respondent do something. He then ordered a quantitative Beta-subunit Human Chorionic Gonadotropin blood test to determine her hormone level. On November 2l, 1986, Respondent called C.W. at her place of employment, and informed her that her hormone levels were extremely low, and that she might not have a viable pregnancy. He told her she should keep her next regularly scheduled appointment with him, but if she experienced any severe bleeding or cramping to call him. C.W. left work and became increasingly upset. She contacted him later on that same day for a more complete explanation of what she should expect. Respondent told her that the fetus was "reversing itself and was losing weight instead of gaining." C.W. was not informed by Respondent that the fetus was not viable, and she took his advice to mean that if she was extremely careful there was still a chance of carrying the pregnancy to term. Respondent admitted to the Petitioner's investigator, Jim Bates, that he knew the fetus was dead at this time, but he was trying to let nature take its course, and if she did not abort in two or three months, he would take the fetus. Because she was extremely upset and her friends were concerned about the advice she was receiving from the Respondent, an appointment with another obstetrician, Dr. Vincent Gatto, was made for C.W. by one of her friends. Dr. Gatto saw C.W. on or about November 21, 1986, and after examining her he immediately diagnosed her as having had a missed abortion. A sonogram confirmed this diagnosis. A dilation and curettage was performed on C.W., and subsequent pathological reports revealed remnants of an 8-week fetus. The medical records which Respondent maintained of his care and treatment of C.W. are incomplete and contain discrepancies concerning his evaluation of the patient. They do not reflect C.W.'s numerous telephone calls, or that she was increasingly upset over the course of her pregnancy. There is no delineation of a plan of treatment in these records, or any explanation of the type of treatment he was pursuing for her. There is no explanation or justification in these records of Respondent's failure to order a sonogram or test, other than the one Beta-subunit Human Chorionic Gonadotropin, for C.W., although she repeatedly reported vaginal bleeding and cramping, and there was a continuing inability to detect a fetal heartbeat. Respondent failed to carry out the correct tests on C.W., and therefore, he failed to make a correct diagnosis of missed abortion, or to treat her correctly. He allowed her to carry a dead fetus for almost two months. Retention of the products of a non-viable pregnancy can lead to several complications, including infection, blood clotting and psychological trauma. In fact, this experience caused C.W. severe emotional anguish. In his care and treatment of C.W., Respondent failed to meet the standard of care that is required of a physician practicing under similar conditions and circumstances.
Recommendation Based upon the foregoing, it is recommended that Florida Board of Medicine enter a Final Order suspending Respondent's license to practice medicine for a period of five years, and imposing an administrative fine of $3,000. DONE AND ENTERED this 21st day of August, 1989 in Tallahassee, Florida. DONALD D. CONN Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 Filed with the Clerk of the Division of Administrative Hearings this 21st day of August, 1989. APPENDIX (DOAH CASE NO. 88-4785) Rulings on the Petitioner's Proposed Findings of Fact: Adopted in Finding l. Adopted in Finding 2. Adopted in Finding 3. Adopted in Finding 4. Adopted in Finding 5. 6-7. Adopted in Finding 6. Adopted in Finding 7. Adopted in Finding 8. Adopted in Finding 9. Adopted in Finding 10. Adopted in Finding 11. Rejected as irrelevant. 14-17. Adopted in Finding 13. 18-21. Adopted in Finding 12. 22. Adopted in Finding 14. The Respondent did not file Proposed Findings of Fact. COPIES FURNISHED: Mary B. Radkins, Esquire Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, FL 32399-0792 Allen B. Erde, M.D. P. O. Box 1817 Winter Haven, FL 33883-1817 Allen B. Erde, M.D. 198 First Street, South Winter Haven, FL 33880 Dorothy Faircloth Executive Director Northwood Centre 1940 North Monroe Street Tallahassee, FL 32399-0792 Kenneth Easley, General Counsel Northwood Centre 1940 North Monroe Street Suite 60 Tallahassee, FL 32399-0729
The Issue The issues to be determined in this proceeding are whether Respondent, John L. Lentz, Jr., M.D., committed the disciplinary violations charged with respect to seven patients in three Administrative Complaints that have been consolidated for the purpose of hearing. If the facts demonstrate that any of the charged violations have been committed, then the appropriate penalty to be imposed for such violations must be recommended.
Findings Of Fact Based upon the testimony and documentary evidence presented at hearing, the demeanor and credibility of the witnesses, and on the entire record of this proceeding, the following findings of fact are made: Petitioner is the state agency charged with the licensing and regulation of the practice of medicine pursuant to section 20.43 and chapters 456 and 458, Florida Statutes. At all times material to these proceedings, Respondent was a licensed physician in the State of Florida, having been issued license number ME 82437. Respondent’s address of record is 15200 Emerald Coast Parkway, St. Marten Unit 506, Destin, Florida 32541. Respondent was board-certified by the Academy of Family Physicians until 2009. He currently holds no board certification in any specialty area, and did not complete any residency other than his residency in family medicine. Respondent went to medical school at the University of South Carolina and initially practiced in that state. He moved to Florida in 2001 and since that time, has worked in a variety of practice settings, including working as an emergency room physician in several hospitals in areas such as Phenix City, Alabama; Panama City, Florida; and Defuniak Springs, Florida. At some point, Respondent became interested in the diagnosis and treatment of Lyme disease, and in approximately 2007, he opened a clinic in Destin named the Lentz Lyme Clinic. Respondent attended four continuing medical education courses that focused on the diagnosis and treatment of Lyme disease. Each of the courses he attended was three to four days long. Diagnosis and Treatment of Lyme Disease Lyme disease is an infectious disease caused by the bacteria Borrelia burgdorferi. Lyme disease is typically transmitted by a tick bite from what is often referred to as a deer tick, more formally known as the Ixodes scapularis tick. The tick is usually very small, and must remain on the person’s skin for approximately 36 hours or more in order for the disease to be transmitted. Lyme disease is generally considered to be endemic to the Northeastern United States, in states such as the New England states, Pennsylvania, upstate New York, Delaware, and northern Virginia. While it is not impossible to contract Lyme disease in Florida, the more persuasive evidence established that it is not prevalent in this state. The most credible, compelling evidence presented established that most people who are diagnosed in Florida with Lyme disease were most likely infected while traveling in a part of the country that is endemic for the disease, and that states in the Southeastern United States are in a low-risk area for Lyme disease. There was some conflict in the testimony concerning the stages and symptoms of Lyme disease, and what factors should be considered in diagnosing the disease at the various stages. The more credible and persuasive descriptions of Lyme disease and its stages describe the disease as having three stages: early localized Lyme disease; early disseminated Lyme disease; and late Lyme disease. The probable stage of the disease at the time a patient presents for diagnosis and treatment determines what is necessary for a diagnosis. Early localized Lyme disease is the disease as it typically presents within the first four weeks of the tick bite. The patient often, but not always, presents with a rash called an erythema migrans, which is generally over five centimeters wide (and can be as large as 19 centimeters) and is sometimes clear in the center, leading to the term “bull’s-eye rash” to describe it. In addition to the erythema migrans, a patient may present with virus-like symptoms, such as fatigue, malaise, fever, chills, myalgia (muscle aches), and/or headache. Often the symptoms at this stage, or any stage, for that matter, are non-specific symptoms that are common to a variety of conditions, including ALS and MS. According to Respondent’s expert, Dr. Cichon, these are conditions that a physician should also consider when diagnosing Lyme disease, Babesiosis, or Bartonellosis. In other words, when a patient presents with symptoms that do not include the erythema migrans, but are vague and non-specific, Lyme disease and co-infections related to Lyme disease should not be the only diagnoses considered. In order to diagnose Lyme disease a thorough history is required, including information on a patient’s travel locations, whether travel included states that are typically endemic for Lyme disease; the time of year the travel occurred; whether the patient engaged in the type of activity (such as hunting, fishing, hiking, or other outdoor activities) that would expose him or her to the possibility of a tick bite; any history of rashes; and whether the patient remembers a tick bite. The history should also include any symptoms the patient is experiencing and when the symptoms began. If the patient reports travel to an endemic area, and presents with an erythema migrans that the physician can examine, a diagnosis of early Lyme disease can be made without confirmatory laboratory tests. At that early stage, laboratory tests would not be particularly useful because they detect antibodies to the Borrelia burgdorferi, as opposed to detecting the bacteria itself. At that early stage of the disease, there is not sufficient time for the body to develop the antibodies necessary for detection through laboratory testing. The second stage of Lyme disease is called early disseminated Lyme disease, which may be characterized by multiple erythema migrans lesions; cardiac symptoms, such as atrioventricular block; arthralgia (joint pain); myalgia; or neurologic involvement, such as lymphocytic meningitis, facial nerve Palsy (Bell’s palsy), or encephalitis. If a patient presents with some combination of these symptoms, along with a history indicating travel to an endemic area and activities in that area consistent with tick exposure, a reasonable prudent physician would seek confirmatory laboratory tests to reach a diagnosis of Lyme disease, assuming the patient presents four weeks or more after possible exposure to a tick bite. The type of test to use is discussed below. Late Lyme disease is characterized by neurological symptoms, such as encephalomyelitis, peripheral neuropathy; and arthritis and arthralgia, usually in a single joint, such as a knee. As with early disseminated Lyme disease, a thorough history and physical is required for a diagnosis, as well as a confirmatory laboratory test. There was a great deal of testimony presented regarding the type of testing that is appropriate for the diagnosis of Lyme disease. Petitioner advocated the use of the ELISA test, followed by the Western blot test, commonly referred to as the two-tiered approach. ELISA and Western blot will be discussed in more detail below. Respondent contends that this two-tiered approach is inaccurate and that other tests are more definitive. His argument regarding the testing to use is consistent with his claim that there are two “standards of care,” one recognized by the Infectious Disease Society of America (IDSA), and one recognized by the International Lyme and Associated Diseases Society (ILADS). The tests recognized as standard for diagnosis of Lyme disease by Drs. Robbins, Anastasio, Robertson, Rosenstock, and Powers, are the two-tiered approach ELISA and Western blot tests. The ELISA is an enzyme-linked immunosorbent assay screening test. If the screening test is positive or equivocal for enzymes indicative of Lyme disease, a Lyme Western blot test is performed to confirm the presence of antibodies to Borrelia burgdorferi. For patients with early Lyme disease, the two-tier testing process may produce false negatives because the patient has not had sufficient time to develop antibodies in response to the bacteria. For those with late Lyme disease, the test is highly sensitive and specific because late Lyme disease patients have ample time to develop antibodies. The two-step approach is recommended by the Centers for Disease Control (CDC) because it provides for both sensitivity and specificity. Usually lab tests are either sensitive or specific, but not both. For a test to be considered “sensitive,” there are no false negatives. ELISA is considered a sensitive test. Specificity refers to the specific antibody bands being evaluated. With Western blot, there is an examination of different specific antibody bands. A Western blot IgM test looks for antibodies that are created initially from white blood cells that specifically attach to the infectious organism. A Western blot IgG looks for a different set of antibodies that continue to persist long after the infection is gone. A Western blot IgG is considered positive if five of the ten antibody bands are positive, while an IgM is considered positive if two of three bands are positive. The ILADS guidelines criticize use of the ELISA and Western blot tests because in the organization’s view, the two- tiered testing lacks sensitivity. The guidelines state that several studies “showed that sensitivity and specificity for both the IgM and IgG western blot range from 92 to 96% when only two [as opposed to five] specific bands are positive.”2/ While the ILADS guidelines criticize the two-tiered approach represented by ELISA and Western blot and indicate that other testing has been evaluated, “each has advantages and disadvantages in terms of convenience, cost, assay standardization, availability and reliability.” The ILADS guidelines do not expressly advocate not using the ELISA and Western blot, and note that while other tests remain an option to identify people “at high risk for persistent, recurrent, and refractory Lyme disease,” the tests have not been standardized. Dr. Michael Cichon, testifying for Respondent, opined that the ELISA and Western blot tests had little value and that Respondent’s failure to use them was not a departure from the standard of care. However, while at hearing he denied that he would order either test, in his deposition he indicated that he would order both tests, as a guide to diagnosis. His testimony that the ELISA and Western blot tests are not useful in the diagnosis of Lyme disease is rejected as not credible. Clear and convincing evidence at hearing established that a reasonable, prudent physician who is presented with a patient having possible exposure to Lyme disease occurring four weeks or more before seeing the physician would order the two- tier testing of ELISA and Western blot if it was appropriate to test for Lyme disease. While performing other tests in conjunction with the two-tier tests is not per se a departure, the standard of care requires either ordering the ELISA and where necessary, the Western blot, or reviewing any test results for these tests previously obtained by the patient. Treatment of Lyme disease also depends on the stage at which the condition is diagnosed. If a patient is diagnosed with early localized Lyme disease, a single course of doxycycline for 14 to 28 days is generally appropriate. Early disseminated Lyme disease and late Lyme disease may be treated with IV antibiotics, for a similar period of time. In summary, the standard of care in the diagnosis and treatment of Lyme disease requires a physician to take an appropriate medical history, perform a physical examination, obtain objective laboratory test results in the absence of an erythema migrans rash, and refer patients who do not improve after an initial course of antibiotic treatment to an infectious disease specialist for further evaluation. An appropriate history must include the information described in paragraph nine, and the testing to be ordered should include an ELISA and, where positive or equivocal, a Western blot test. Diagnosis and Treatment of Babesiosis Babesiosis is a parasitic disease of the blood caused by infection with Babesia. Babesiosis, like Lyme disease, is typically transmitted by a tick bite, and can be transmitted by the same tick that carries Lyme disease. There are occasions when a patient properly diagnosed with Lyme disease also will have Babesiosis as a co-infection. It is, however, not a common diagnosis, and even infectious disease specialists may go an entire career without diagnosing it. If a family practice physician suspects Babesiosis, the better approach would be to refer the patient to an infectious disease specialist. However, failure to refer a patient to a specialist, assuming that the family physician performs the appropriate testing and treatment, is not necessarily a departure from the standard of care. At all times material to the allegations in the Administrative Complaints, the standard of care for the diagnosis and treatment of Babesiosis included the physician taking an appropriate medical history, performing a physical examination of the patient, and obtaining objective laboratory test results in order to make an evidence-based diagnosis. As with Lyme disease, the patient’s medical history should contain information regarding the patient’s travel; whether they had exposure to a tick bite; whether they recall being bitten by a tick; as well as what symptoms the patient is experiencing. Babesiosis typically presents with virus-like symptoms, fever, sweats, and the identification of Babesia parasites in the patient’s blood. The tests that a reasonably prudent similar physician would order to determine whether a patient had Babesiosis are either a blood smear to identify Babesial parasites or a polymerase chain reaction (PCR) amplification of Babesial DNA. Should a patient be diagnosed with Babesiosis, the normal and customary treatment is a ten-day course of clindamycin and atovaquone. Diagnosis and Treatment of Bartonellosis Bartonellosis is an infectious disease caused by bacteria of the genus Bartonella. It is generally transmitted by lice or fleas on a person’s body, coming off of other animals, such as rats. It also can be transmitted through a cat scratch, as the cat gets fleas under its claws by scratching itself. As is the case with Babesiosis, a family practice physician is unlikely to diagnose Bartonellosis. It is not a common diagnosis, and even infectious disease specialists may go an entire career without diagnosing it. If a family practice physician suspects Bartonellosis, the better approach would be to refer the patient to an infectious disease specialist. However, failure to refer a patient to a specialist, assuming that the family physician performs the appropriate testing and treatment, is not necessarily a departure from the standard of care. In order to make a diagnosis, a thorough history and physical is required, along with objective laboratory test results. A physician should inquire about exposure to animals that could carry fleas, ticks, or lice, and whether there had been any recent instances where the patient has been scratched by a cat. The symptoms of Bartonellosis are nonspecific and include fever, headaches, myalgia, and arthralgia. The generally accepted test used to confirm a diagnosis of Bartonellosis would be a PCR amplification of Bartonella DNA, or paired blood serologies. DOAH Case No. 15-2888PL; DOH Case No. 2011-15106 (Patient C.C.) From approximately September 28, 2010, through approximately February 28, 2012, Respondent provided medical care and treatment to patient C.C. At the time of her original presentation to Respondent, C.C. was 27 years old. Prior to seeing Dr. Lentz, C.C. had a series of orthopedic injuries. For example, in 1998, C.C. was involved in a serious car accident, resulting in multiple broken bones and internal injuries requiring a two-week stay in the hospital. C.C. joined the Air Force in 2006, where she served as an aircraft mechanic. During basic training she suffered an injury to her shoulder, which caused problems with her neck, back, and shoulder. While in the military, C.C. was involved in two additional accidents: she broke her wrist in a motorcycle accident at some point, and on March 31, 2009, she had a second accident where the car she was driving was struck by another vehicle. While C.C. denied any injuries as a result of this second accident, shortly thereafter in July 2009, she had neck surgery because of discs impinging on the nerves in her neck. C.C.’s work as an aircraft mechanic required her to work in the fuel tanks of an airplane, which is a very confined space. C.C. is approximately 5’10” tall, and the work she performed required her to become contorted in a very small space for approximately 13 hours at a time. After her neck surgery, she started having increasing amounts of pain in her back and hips, to the point where she could no longer perform her job duties and in August of 2010, resorted to a wheelchair because of her inability to walk. Although she consulted multiple doctors both in the military and through referrals to outside physicians, she did not discover the cause of her pain. On or about September 28, 2010, Respondent evaluated C.C. for complaints of severe back, buttock, and right leg pain. When she presented for her first office visit, Dr. Lentz’s review of symptoms indicated that C.C. had a frontal headache with pain at a level of 10 out of 10; sensitivity to light and sound; loss of hearing and buzzing; nausea but no vomiting; withdrawal symptoms described as sweats when she did not take Ultram or Lortab; and feelings of hopelessness and emotional lability. His physical examination reported that C.C. was in a wheelchair, and documented “soles of feet painful, SKIN: rashes, soles of feet red, NEURO: paresthesia, pain, tender extremity.” At that time, Respondent diagnosed C.C. as having chronic fatigue syndrome and chronic pain syndrome. In C.C.’s history, Respondent noted that she “grew up in Texas/Arkansas-hunting, forests, etc. There is no notation of recent travel on this first visit. Dr. Lentz asked her about any flu-like symptoms, which she denied having. Many of the symptoms listed by C.C. are general symptoms that are common to a variety of ailments. Respondent, however, focused only on chronic fatigue, chronic pain, Lyme disease, Babesiosis, and lupus. On this first office visit, Respondent prescribed CD57, C3a, C4a, and eosinophilic cationic protein (ECP) laboratory tests of C.C.’s blood. With respect to the order for CD57, Respondent listed Lyme disease as a diagnosis. For the C4a and C3a, he listed Lyme disease and Lupus as the diagnoses, and for the ECP he listed a diagnosis of Babesia infection. Respondent did not prescribe an immunoassay (ELISA) test or Western blot test for Borrelia burgdorferi for C.C. The ECP test result for C.C. collected on October 6, 2010, was 20.8. The reference range for a normal test result is 1-10. The notation for the test on the lab result states: This test uses a kit/reagent designated by the manufacturer as for research use, not for clinical use. The performance characteristics of this test have been validated by Advanced Diagnostic Laboratories at National Jewish Health. It has not been cleared or approved by the US Food and Drug Administration. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. On or about October 15, 2010, Respondent diagnosed C.C. with Lyme disease. He based his diagnosis of Lyme disease on the results of the CD57 blood test. The CD57 test is a cluster designation test that measures a marker found on lymphocytes, which are a type of white blood cell that are sometimes referred to as natural killer cells. Although Respondent claimed at hearing that he did not consider the test to be definitive, in his deposition he indicated that he believed that it was in fact definitive. Dr. Cichon, on the other hand, testified that the CD57 test used by Dr. Lentz is not a definitive test for Lyme disease, but is useful for measuring the progress of treatment. At least one test result for C.C. reflecting the results for a CD57 panel has the following notation from the laboratory: This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Results of this test are for investigational purposes only. The result should not be used as a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic product or procedure. On or about October 15, 2010, Respondent also diagnosed C.C. with Babesiosis. Respondent did not prescribe a blood smear examination for Babesial parasites or PCR amplification for Babesial DNA for C.C. He based his diagnosis on the ECP test. On October 15, 2010, Dr. Lentz received an e-mail from C.C.’s roommate, M.B., informing him that C.C. had visited the emergency room over the weekend because of the level of her pain. The e-mail asked whether C.C. could begin with her treatment before her next appointment. In response, Dr. Lentz called in prescriptions for doxycycline and Cleocin, both of which are oral antibiotics. On or about October 18, 2010, Respondent described C.C. as being in no acute distress, with a gait that is within normal limits. He also noted some wheezing, pain all over, tears, and cramps in her muscles. Respondent prescribed long-term IV antibiotic therapy and referred C.C. to a specialist for venous port placement for the administration of intravenous (IV) antibiotic therapy. The specific medications prescribed at this visit are acetaminophen-oxycodone 300 mg - 7.5 mg oral tablets to be taken three times daily; Cymbalta 30 mg oral, once a day; Flagyl 500 mg oral tablets, to be taken three weeks on, one week off; heparin 5000 units/ml injectable solution, once a day; Omnicef 300 mg oral capsules, once a day; Interfase Plus Prothera, a supplement; and boluoke lumbrokinase, also a supplement. At the October 18, 2010, visit, he also ordered a Fry test for Bartonellosis and prescribed intravenous vancomycin, with weekly vancomycin trough levels. Dr. Lentz testified at hearing that the prescription for vancomycin was to treat Bartonellosis.3/ However, at this juncture, no diagnosis for Bartonellosis had been made. Heparin is an anticoagulant that is used for a variety of issues, such as blood clots, pulmonary emboli, and Berko emboli. It is also used in coronary heart disease if a patient has a myocardial infarction. The more persuasive and credible testimony established that it was below the standard of care to use heparin in the treatment of Lyme disease, Babesiosis, or Bartonellosis. Not only did heparin have no efficacy, it had the potential to be very dangerous for C.C., or any other patient. On October 28, 2010, Respondent noted that the vancomycin was at 1.5 grams and still not therapeutic, and ordered that the medication be changed to Primaxin and that the Omnicef and vancomycin troughs be stopped. On November 10, 2010, Respondent noted that C.C. was experiencing flu-like symptoms, but was now resting fewer hours each day. For the first time, he noted “past 4 years in military=Virginia, Canada, Honduras, as sites for exposure to Lyme.” He also noted “no wheelchair, but slow to move, pain to rt LS-hip-leg.” He continued to list her diagnoses as Lyme disease, Babesiosis, chronic pain syndrome, and chronic fatigue syndrome. Respondent also saw C.C. in the office on December 8, 2010, and January 10, 2011. At the December 8, 2010, visit, he discontinued the use of Flagyl because of her nausea and switched to Tindamax (one tablet daily for three weeks, then off one week) instead. On January 19, 2011, Dr. Lentz received an e-mail from C.C.’s roommate regarding a fall C.C. had over the weekend. As a result, he wrote an e-mail to C.C. and told her to stop the Tindamax and “add the neurotoxins to remove the neurologic toxins that are being created by the antibiotics.” He also directed her to stop the heparin injections, as she needed to be off of heparin before having some hand surgery to remove a cyst. C.C. returned for an office visit on February 9, 2011. At that time, Respondent’s notes indicate that she was ambulatory but still significantly fatigued and still falling. He noted, “rt hip. sciatic nerve still #1 symptom, can not stand or walk for long periods of time, not sure if neurologic/Lyme or degenerative nerve dis.” In his assessment, he stated she “needs CT lumbar sacrum to r/o orthopedic issue with back pain.” During the course of treatment, Respondent was consistently prescribing OxyContin at 10 mg, three times daily. On March 16, 2011, he referred C.C. to Dr. Beach at Andrews Institute to detox off the OxyContin. He also noted that she had been given 100 percent disability through the military, and would take approximately four months to process out of the military. He also noted “electrical ablation at T9, T10 for chronic back pain per Dr. Nyguen.” Dr. Lentz continued to see C.C. on April 12, 2011; May 4, 2011; and May 13, 2011. Throughout her treatment with IV antibiotics, C.C. experienced problems with nausea, rashes, and diarrhea, but claims that over time, her symptoms began to improve so that she could walk and eventually was able to hold down part-time employment. Toward the end of her military tenure, C.C. needed a referral in order to continue to see Dr. Lentz. To that end, on June 8, 2011, she saw Dr. Janelle Robertson, M.D., a board certified infectious disease specialist at Eglin Air Force Base. Dr. Robertson evaluated C.C. for Lyme disease, and documented her history, including travel history and history of tick bites. She reviewed prior records from Eglin Air Force base that indicated C.C. had an ELISA screening on June 10, 2010 (approximately two and a half months before seeing Dr. Lentz), that was negative. The ELISA test was not only performed before C.C. saw Dr. Lentz, but well after C.C. began suffering the symptoms that led her to seek out Dr. Lentz. Accordingly, the ELISA test was administered at a time at which C.C. would have developed sufficient antibodies for the test to be useful. Dr. Robertson also noted that while C.C. had a history of tick bites in Florida, Texas, and Alabama, she did not report any rashes or illness at or near the time of the tick bites. She also had no history of migratory arthralgia or Bell’s palsy. Dr. Robertson testified credibly that C.C. was having no night sweats, weight loss, changes in vision, palpitations, difficulty breathing, or gastrointestinal problems, and that her primary complaint was back and hip pain. C.C.’s pain remained in the same locations and persisted without resolution since 2009. Dr. Robertson concluded that C.C. did not have Lyme disease, and that her prior negative ELISA test conclusively established that she did not have the disease. She opined that, given that C.C.’s symptoms had persisted since 2009, if she had actually had Lyme disease, she would have developed antibodies that would have been detected with the ELISA test. She also determined that Respondent did not have Babesiosis and recommended to C.C. that she immediately stop the therapy prescribed by Dr. Lentz, because in Dr. Robertson’s view, the therapy was unsafe. C.C. has since transitioned out of the military into civilian life. Although she believes that the treatment by Dr. Lentz was effective in treating her condition, the events since she stopped treatment for Lyme disease suggest otherwise. For example, C.C. testified in her deposition that her treatment ended in mid-May 2011 because Dr. Lentz determined that she did not need more treatment, yet it appears that the military would no longer authorize treatment by Dr. Lentz once C.C. saw Dr. Robertson. Moreover, she continues to have some of the same pain that led her to treatment with Dr. Lentz. In approximately October 2014, she had hip surgery because her “hips are pretty much shot.” She has had three surgeries for kidney stones, steroid injections for temporary relief from her back pain, and acupuncture treatments for her back pain. At least one physician attributed her problem to the kind of work she performed as an aircraft mechanic, and at deposition she indicated that a recent MRI indicated that she has some lumbar narrowing. In short, it appears that the months-long IV antibiotic therapy she endured has provided no lasting solution to her pain. Respondent’s care and treatment of C.C. was a departure from the standard of care in that he diagnosed Lyme disease based upon an inadequate history and no objective laboratory test results from an ELISA test and Western blot. Specifically, Respondent failed to obtain C.C.’s travel history or any history of rashes, possible tick bites, including the size of the tick, and in fact obtained a history devoid of any flu-like symptoms characteristic of Lyme disease. C.C.’s primary symptoms were related to her back pain. Respondent’s own expert, Dr. Cichon, testified that the key to a diagnosis of Lyme disease is the patient’s history.4/ With this inadequate history in mind, Respondent did not obtain an ELISA test or Western blot, but instead relied on a test that, on its face, indicates that it is for investigational use only and should not be used as a diagnostic procedure without confirmation of the diagnosis by another medically-established diagnostic product or procedure. The more persuasive and compelling testimony established that the failure to obtain objective laboratory confirmation of Lyme disease through the use of the ELISA and Western blot tests is a departure from the standard of care recognized by a reasonably prudent similar physician. The more persuasive and compelling evidence also established that C.C. did not actually have Lyme disease, despite Respondent’s diagnosis of the disease. Respondent also departed from the appropriate standard of care by his failure to use the appropriate tests for the diagnoses of Babesiosis and Bartonellosis. His test of preference, the ECP test, is by its own terms, not intended to be used as the sole means for clinical diagnosis or patient management decisions. As stated by Dr. Robbins, it has no clinical relevance and is diagnostic of nothing. Likewise, his credible testimony indicated that use of the Fry test was not appropriate, as it is a proprietary test of the laboratory and not FDA approved.5/ Respondent’s care and treatment of C.C. also departed from the applicable standard of care by prescribing surgery for placement of a venous port for administration of intravenous medication, and by prescribing both intravenous and oral antibiotic therapy in inappropriate and excessive amounts. The more credible and persuasive testimony demonstrated that C.C. did not have Lyme disease, Babesiosis, or Bartonellosis, and therefore did not need any of the antibiotic therapy prescribed. Even had C.C. received a correct diagnosis, the more persuasive evidence demonstrated that the amounts and duration of the antibiotics prescribed were not only unwarranted, but potentially dangerous for the patient. C.C. had the possibility of negative reactions from the many antibiotics prescribed, but also the very real possibility that she has built up a resistance to the antibiotics such that they will be ineffective should she actually need them in the future. Finally, Respondent’s care and treatment of C.C. departed from the applicable standard of care by the prescription of heparin. There was no medical justification for the prescription of an anticoagulant for the treatment of Lyme disease, even if appropriately diagnosed (which did not happen here), and as with the prescription of multiple long-term antibiotics, was potentially dangerous and harmful to the patient. DOAH Case No. 15-2889PL; DOH Case No. 2011-18613 (Patients D.H., S.L., J.L., W.L., and D.D.) Patient D.H. Respondent provided care and treatment to patient D.H. from approximately November 24, 2010, to approximately October 14, 2011. D.H. was previously seen by a physician’s assistant, Thomas Gregory Roberts, who at various times worked under Respondent’s supervision, including the period from April 29, 2009, to May 26, 2010, and again from September 21, 2010, through December 18, 2010.6/ Mr. Roberts had ordered a previous CD57 test for D.H., and had prescribed doxycycline for him on a long-term basis. Mr. Roberts’ office was closing and his records were no longer available, so on November 24, 2010, D.H.’s wife, J.H., e-mailed Dr. Lentz to request laboratory tests and to schedule an appointment for D.H. She stated in part: Dear Dr. Lentz: Both my husband and I have been to you before, but not at your current office. [D.H.] went to Tom Roberts at Village Health Assoc. and was sent for blood work. His CD57 counts were off, so he put him on Doxycycline [sic] and was on it for several months. His last blood work was done in July and by the sound of it showed some improvement, but he told him to stay on the antibiotics. Tom Roberts gave him an order for follow up bloodwork which reads CD57 + NK Cells Dx2793. Since he is currently not practicing that we know of, we are requesting that you please write an order so that [D.H.] can have blood work done and come to you for the results. Based upon this e-mail, Respondent ordered a CD57 test, using the diagnostic code for and reference to Lyme infection, and an ECP test using the diagnostic code for and reference to Babesia infection. He did so without actually seeing D.H., taking a history, or performing a physical examination. Respondent diagnosed D.H. as having Lyme disease and Babesiosis. He communicated the diagnoses to D.H. on December 25, 2010, via e-mail, stating, “CD57 is positive for Lyme and ECP positive for Babesia. Call Amy at 424-6841 for an appointment. Dr. Lentz.” It does not appear from the record that he considered or ruled out any other condition for D.H.’s complaints. Respondent did not prescribe or order for D.H. an ELISA or Western blot test, PCR amplification of Bartonella or Babesial DNA, or blood smear tests at any time during D.H.’s care and treatment. Respondent did not refer D.H. to a specialist in the diagnosis and treatment of infectious diseases, such as Lyme disease, Bartonellosis, and Babesiosis at any time during Respondent’s treatment and care of D.H. D.H.’s first office visit was January 17, 2011. At that time, J.H., D.H.’s wife, who attended the majority of his doctor’s visits with him, testified that his only complaint at that point was fatigue, and ongoing diarrhea she attributed to the lengthy time he had already been on antibiotics. She acknowledged that he checked off those items on a form at the doctor’s office, but was not going to see Dr. Lentz complaining about those: he went simply because of his fatigue. He had no rash at that point, and never complained of a tick bite. Dr. Lentz’s records, however, indicate that he complained about exhaustion; face-neck, jaw, and orbital pain; diarrhea; cramping; stiff and painful joints; mood swings; irritability; explosive [sic]; and poor concentration. From what J.H. could remember, the physical examination Respondent performed on D.H. was very brief. Respondent took D.H.’s blood pressure, possibly looked in his mouth, palpated his abdomen, and did a knee reflex test. She did not remember him doing anything else, except having D.H. fill out a long form. Dr. Lentz’s medical records for this visit contain no prior medical history, no pulse, and no respiration rate. Respondent diagnosed D.H. with Lyme disease. When J.H. asked him if he was sure, Respondent said, absolutely. J.H. had done some research and knew that Respondent had only ordered a CD57 for D.H. She asked him about ordering the Western blot, but he did not order it. She could not remember Respondent’s exact response, but was led to believe that he did not think that the Western blot test was as accurate in diagnosing Lyme disease. At this first visit, Respondent also ordered the Fry test. Results from the Fry test are dated January 25, 2011, and indicate: Based on the accompanying test results for the sample for listed patient and accession number is suggested for follow up confirmation of the putative organism(s). Protozoan: The Special Stains (100x magnification) or the Advanced Stains (magnification listed) for this sample is suggestive of a protozoan. PCR testing for putative FL1953 is suggested for follow-up confirmation. EPierythrozoan/Hemorbartonella: The Special Stains (100x magnification) or the Advanced Stains (magnification listed) for this sample is suggestive of epierythrozoan/ hemobartonella. PCR or serology testing for the putative epierythrozoan/hemobartonella (Bartonella spp.) is suggested for follow up confirmation and speciation. (emphasis added). The records do not indicate that Respondent ordered any of the follow-up testing recommended by the Fry laboratory which, ironically, is the very testing for Bartonellosis that a reasonably prudent similar physician should order for this condition. His records also do not indicate that he ever added Bartonellosis as a diagnosis for D.H. During the course of his treatment, Respondent prescribed for D.H. the antibiotics Omnicef, azithromycin, and Cleocin, as well as Interface Plus Prothera (an enzyme supplement formulation), boluoke lumbrokinase (a fibrinolytic supplement), atenolol (a beta blocker used primarily in cardiovascular disease, added March 7, 2011), heparin injections (an anticoagulant, also added March 7), artemisinin (an antimalarial, added June 14), Mepron (an antiparasitic, added June 14), Tindamax (added June 14), Plaquenil (an antimalarial), and Vermox (an anthelmintic)(both added August 21). J.H. understood that, based upon Respondent’s explanations, the heparin was prescribed to help other medicines be absorbed into the cells, or something along those lines. She was concerned about D.H. being on the heparin, in part because as a result of him injecting the heparin in his abdomen, D.H. had a lot of bruising and knots all over his belly. She was also concerned because D.H. worked as a boat captain on the Mississippi River, which required him to be away from home for weeks at a time. She was concerned about the ramifications should he have an accident at work when he had no access to medical care. Her concerns were warranted. The couple also had concerns about the number of medications D.H. was taking while under Respondent’s care. He developed blurred vision, did not sleep well, and had chronic diarrhea. When D.H. came home from his last visit, which J.H. apparently did not attend, he reported that Dr. Lentz had said something about having a port placed for the administration of more antibiotics. That shocked her, so before he would go through with port placement, they sought a second opinion. Dr. Patrick Anastasio is an osteopathic physician who is a board-certified infectious disease specialist. During all times relevant to these proceedings, he was a solo practitioner in private practice at Emerald Coast Infectious Diseases in Fort Walton Beach, Florida. He has worked in the area for approximately 12 years. D.H. sought a second opinion from Dr. Anastasio regarding his Lyme disease and Babesiosis diagnoses. To that end, he saw Dr. Anastasio for the first time on September 29, 2011. Dr. Anastasio did not believe that D.H. had the symptoms initially to place him in a high risk group for Lyme disease. During his examination, he looked for signs that would be consistent with Lyme disease, such as arthritis, cognitive problems, or neurological problems, but did not discover any. Dr. Anastasio did not believe that D.H. had either Lyme disease or Babesiosis, but ordered a blood smear, and a Western blot and a Babesia PCR test to rule out the conditions. All tests came back negative.7/ Dr. Anastasio recommended to D.H. that he stop taking all of the medications prescribed by Dr. Lentz, and D.H. did so. It still took months for the diarrhea, most likely caused by the long-term antibiotic therapy, to subside. However, D.H. began to feel better once he stopped taking the antibiotics. Dr. Charles Powers, M.D., testified that Dr. Lentz’s medical records for D.H. were not adequate for the evaluation of whether D.H. had Lyme disease. He also believed that it was below the standard of care to use the CD57 for the diagnosis of Lyme disease as opposed to the ELISA and Western blot tests, and that it was below the standard of care not to order the ELISA and Western blot tests in the absence of an erythema migrans rash that Dr. Lentz could physically observe. Dr. Powers believed that there was no basis upon which to diagnose D.H. with Lyme disease, and therefore any treatment based on this faulty diagnosis would be below the standard of care. Even assuming the diagnosis was correct, Dr. Powers opined that the treatment ordered also was below the standard of care. According to Dr. Powers, a reasonably prudent family practitioner would usually prescribe doxycycline for the majority of cases, as opposed to the regimen of medications used by Dr. Lentz. Prescribing antibiotics the way they were prescribed would include adverse side effects, such as nausea and/or diarrhea with resistance to bacteria; development of C. difficile infection, which can be difficult to treat; and potential for allergic reactions, which can be fatal. Dr. Powers testified that when a combination of antibiotics is being used, with each additional antibiotic prescribed, the risk for complications increases exponentially. His testimony is credited. Dr. Powers also opined that the use of heparin in the treatment of Lyme disease, Babesiosis, or Bartonellosis was a departure from the standard of care, and was a dangerous choice for this or any other patient who did not have a need for a blood thinner. Dr. Robbins also believed that Respondent’s care and treatment of D.H. was below the standard of care. He testified that Respondent breached the standard of care by diagnosing D.H. with Babesiosis using the ECP test and the Fry testing for the purpose of diagnosing Bartonellosis. He also testified, consistent with Dr. Powers, that using heparin in the treatment of any of these three diseases was an egregious departure from the standard of care. The testimony of Drs. Robbins and Powers is credited. Dr. Cichon expressed concerns about the amount of medications prescribed by Dr. Lentz to D.H., specifically singling out the prescriptions for Plaquenil and Vermox. While his testimony fell far short of declaring that prescribing these medications represented a departure from the standard of care, his testimony was certainly not a ringing endorsement. It seemed as if he was trying to convince himself that Respondent’s care and treatment of this patient fell within the standard of care. His testimony to that effect is rejected as not credible. D.H. did not have a medical condition that justified the prescription of any of the medications and supplements that Dr. Lentz prescribed, much less for the duration taken. The prescription of any of these medications without a valid diagnosis was a departure from the standard of care attributed to a reasonably prudent similar physician. Patient S.L. Respondent provided care and treatment to patient S.L. from on or about August 17, 2010, to on or about January 7, 2011. On or about August 17, 2010, at her first office visit with Dr. Lentz, S.L. presented with and reported to Respondent a history of heavy rectal bleeding, which occurred every four to five days. At that visit, S.L. informed Respondent that in June, she had been advised to get a colonoscopy. Because of economic constraints, S.L. did not obtain the requested colonoscopy. There is no indication in the patient records for S.L.’s first office visit (or any later visit) that the reason for S.L.’s bleeding prior to his treatment of her had been determined or that it had resolved. S.L. first went to see Dr. Lentz at Hope Medical Clinic8/ because she believed that she had a urinary tract infection. She also had severe back pain, with pins and needles down both legs. Her back pain had started in 2005, following a car accident. S.L. does not recall Respondent ever performing a physical examination, although the patient records indicate that at least a minimal examination was performed. She does recall him talking to her about being from Pennsylvania, but does not recall him asking her about any travel history, whether she had been exposed to ticks, or had ever been bitten by a tick. Dr. Lentz’s medical records for this first visit make no mention of a travel history; no mention of tick exposure; and no mention of any type of rash. Much of the history related to other issues, such as S.L.’s history of bleeding, as opposed to any symptoms that could be said to be indicative of Lyme disease. The symptoms documented are “paresthesis to both legs due to lumbar path. Recent hematochezia. No melena. No upper abd. Pain. No diarrhea. Mostly awake sxs, not hs.” Yet in his assessment/plan notes, he lists diagnoses of lumbago, displacement of lumbar intervertebral disc without myelopathy, and chronic pain syndrome. He prescribed Lyrica, Elavil, Lortab, and ordered a CD57, listing the Lyme disease diagnostic code. There was no medical basis, based on the history presented, to suspect or test for Lyme disease. On September 21, 2010, S.L. presented to Dr. Lentz for a follow-up appointment. At this appointment, Respondent diagnosed S.L. as having Lyme disease. He ordered a Fry Bartonella test as well as an ECP test, and prescribed doxycycline, Omnicef, and Flagyl. On September 30, 2010, S.L. called Respondent and reported throwing up all of her antibiotics, and asked about medication for her nausea. Dr. Lentz added the diagnosis of Bartonellosis without seeing S.L. or performing any further physical examination. The results of the Fry test in the patient records state: “rare (1-4 organisms per total fields observed) coccobacilli adherent to erythrocytes – indicated by yellow arrow(s). This is suggestive of Hemobartonella(1) or Hemoplasma(2).” The notes also state, “[t]his stain is not FDA approved and is for research only.” At S.L.’s next appointment on October 5, 2010, Dr. Lentz prescribed rifampin and Cleocin, as well as Lovenox injections. Lovenox is a low molecular weight heparin that can be given subcutaneously. At the time Dr. Lentz prescribed it, there was no determination regarding the cause of her heavy rectal bleeding just a few months before. On October 19, 2010, just two weeks after starting the Lovenox injections, S.L. presented to the emergency room at Sacred Heart Hospital with complaints of blood in her urine.9/ Physicians in the emergency room attributed the blood in her urine to the Lovenox injections, and discharged her with a diagnosis of hematuria. That same day, she presented to Dr. Lentz and told him about her emergency room visit. Dr. Lentz lowered the dose for Lovenox, but did not discontinue its use. His notes for this visit indicate that she had left flank pain, slight liver tenderness, no masses, and a “light liver test elevated, <2X normal.”10/ He added a diagnosis for Babesiosis, but did not appear to explore what was causing the liver tenderness and elevated tests. Under his assessment and plan, it states: “1. Cut Lovenox BID to QAM. 2. Add Culturelle/probiotics to GI tract due to antibiotics being used, if urine lightens up and less blood on dipstick, then improvement.” Respondent did not prescribe S.L. a PCR amplification or Bartonella or Babesial DNA, or Western blot immunoassay tests at any time during Respondent’s care and treatment of S.L. Respondent did not refer patient S.L. to a specialist in the diagnosis and treatment of infectious diseases, such as Lyme disease, Bartonellosis, and Babesiosis, at any time during Respondent’s care and treatment of S.L. S.L. testified that the physicians at Sacred Heart Hospital informed her that there was no reason for her to be on the antibiotics or blood thinner prescribed by Dr. Lentz, and based upon their advice, she stopped the medication regimen he prescribed. The medical records from Sacred Heart do not mention this advice, and she saw Dr. Lentz at least twice after her emergency room visit: October 19 and November 2, 2010. After that, the only communications in Dr. Lentz’s medical records for S.L. appear to be requests for medication related to urinary tract infections as opposed to treatment for Lyme disease, Babesiosis, or Bartonellosis. In any event, she quit seeing Dr. Lentz for Lyme disease, Babesiosis, and Bartonellosis at least as of November 2, and testified credibly that she feels fine. Based on the credible testimony of Drs. Powers and Robbins, Dr. Lentz’s diagnosis and treatment of S.L. violated the applicable standard of care in that he failed to obtain an appropriate history to diagnose Lyme disease, Babesiosis or Bartonellosis in the first place. He failed to obtain a travel history, any information regarding possible tick bites, and if there was such a bite, the size of the tick and duration of the bite. He also failed to document symptoms that would suggest the possibility of Lyme disease to justify any objective laboratory testing. S.L.’s symptoms were related to back pain and a history of heavy bleeding. Her symptoms simply did not justify testing for Lyme disease. The evidence was not clear and convincing that Respondent failed to perform an adequate examination. As noted above, while S.L. does not remember one, the medical records reflect notations indicating that one was in fact performed. The problem is that the history and physical examination do not support further investigation for Lyme disease. Respondent also departed from the applicable standard of care by relying on tests that were not appropriate for the diagnosis of Lyme disease, Babesiosis, or Bartonellosis. As stated above, there was no basis to test for these conditions at all, but if testing was going to be performed, then the appropriate tests were not the CD57, ECP, and Fry tests, but rather the ELISA, Western blot, PCR, and serologies discussed above. Respondent’s prescription of multiple antibiotics of lengthy duration also violated the standard of care, for reasons discussed above at paragraphs 60 and 79. Likewise, Respondent’s prescription of Lovenox fell below the standard of care. The use of Lovenox for Lyme disease, Babesiosis, and Bartonellosis is not warranted at all, but is especially egregious here, where S.L. had excessive bleeding problems of which Respondent was aware just months before Lovenox was prescribed, with no documentation that the cause of the bleeding had been identified and addressed, and no indication that Respondent did anything to investigate the cause of the bleeding. That he continued to prescribe the Lovenox, albeit at a lower dose, after her visit to the emergency room with hematuria, just compounds the problem. Dr. Cichon testified that Respondent met the standard of care in diagnosing and treating S.L., saying that she had unexplained pain that could be due to Lyme disease. He struggled to identify any symptoms that are commonly associated with Lyme disease. His testimony seemed to indicate anytime there is unexplained pain, Lyme disease is a possibility. His testimony on this issue is not credible. The same can be said for his support of the diagnosis of Babesiosis. Dr. Cichon identified the primary symptoms of Babesiosis as headaches, sweating, and air hunger. S.L. did not have these symptoms, leaving only the ECP test as a basis for diagnosis. Relying on the ECP (which is only slightly elevated) is contrary to Dr. Cichon’s own testimony regarding the primary importance of a thorough history to support such a diagnosis. Similarly, Dr. Cichon acknowledged in his testimony that he could not tell from Respondent’s medical records whether S.L. had any symptoms to support a diagnosis for Bartonellosis, and stated that her symptoms could be due to her lumbar pathology. Given these inconsistencies, his opinion that Dr. Lentz did not depart from the applicable standard of care in the diagnosis of each of these diseases is not credible and is rejected. Medical records must justify the course of treatment for a patient. Dr. Lentz’s medical records for S.L. do not justify the diagnosis or treatment of Lyme disease, Babesiosis, or Bartonellosis. The medical records do not document symptoms that are consistent with the diagnoses of any of these diseases, and fail to provide a complete medical history. Patients J.L., W.L., and D.D. J.L. is the mother of S.L. W.L. is J.L.’s husband and S.L.’s father, and D.D. is S.L.’s son and J.L. and W.L.’s grandson. On September 22, 2010, approximately one month after S.L. began treatment with Dr. Lentz, J.L. wrote him the following e-mail: Dr. Lentz: Thank you for talking with me on the phone today. We are really concerned about S.L. and we can not [sic] express to you how much you are appreciated for all you have done for her. You are a true blessing to our family. My husband was bitten by a tick over the July 4th weekend in MO. He developed the bulleye [sic] rash and went to our family doctor. Dr. Calvin Blount. He was give [sic] 10 days of antibiotics, but no follow up or blood test were ever ordered. We would like to be tested for Lyme. We believe that S.L. might have contracted Lyme before she became pregnant with D.D. and would like him tested also. Here is our information. Please let me know if you need any additional information. Thank you again for all you have done. As noted above, there was an insufficient basis to justify the ordering of any tests related to Lyme disease for S.L. The only basis for ordering tests for D.D. is the suspicion that S.L. may have been infected prior to giving birth to D.D. If there is no basis for suspecting S.L. has Lyme disease, there is no basis for suspecting D.D. has Lyme disease. Respondent did not make an appointment for, take a history from, or perform a physical examination of J.L., W.L., or D.D. Based upon this e-mail alone, he ordered CD57 and ECP tests for all three of them, as well as C4a and C3a tests for J.L. and W.L. To justify ordering the tests, he listed “Lyme Disease (088.81)” under his assessment/plan for each patient. Although he never saw any of these patients, he coded each encounter as “high complexity.” On October 14, 2010, Dr. Lentz sent an e-mail to J.L. stating that “D.D. is positive for Lyme and negative for Babesia.” On October 24, 2010, Dr. Lentz sent an e-mail to J.L. stating, “W.L. C4A is back=20,000+ indicative of active Lyme.” On October 25, 2010, Dr. Lentz sent an e-mail to J.L. which stated, “[t]he CD57 is 50=positive, and the ECP is 11.5=positive for Babesia. My initial charge is $400 and $200 for return visits. Since I will be seeing both you and [W.L.], I will drop that to $300 initial visits. Call Amy for the schedule.” Dr. Lentz testified that he did not diagnose J.L., W.L., or D.D. with any condition, and did not really consider them to be patients. In his view, he was simply doing a favor for the family members of a patient. However, he created records that referred to each patient as being new patients needing tests for Lyme disease, and included diagnostic codes for the lab tests. With respect to each of them, he made an interpretation of the tests that he ordered. At least with respect to D.D., he admitted in his deposition that he diagnosed D.D. with Lyme disease based on the laboratory tests. Both S.L. and W.L. testified credibly that, based on the communications received from Dr. Lentz, they each believed that he had diagnosed them with Lyme disease, and that he had diagnosed J.L. with Babesia. It is found that he did, in fact, provide diagnoses to J.L., W.L., and D.D., without the benefit of a personal history, or a physical examination. Respondent did not refer J.L., W.L., or D.D. to a specialist in the diagnosis and treatment of infectious diseases such as Lyme disease, Bartonellosis, or Babesiosis. Respondent did not order for J.L., W.L., or D.D. an ELISA or Western blot test, PCR amplification of Bartonella or Babesial DNA, or blood smear tests. J.L. and W.L. decided to get a second opinion regarding the Lyme disease and Babesiosis diagnoses, and went to see Dr. Anastasio. Dr. Anastasio testified that J.L. did not have the required exposure to or symptoms for Lyme disease. Because she came to him with a Lyme disease diagnosis, he ordered a Lyme Western blot, a PCR for Babesiosis, and a PCR for Bartonellosis. J.L.’s Western blot IgM was negative, with two of the three antibody bands tested returning as absent. The Western blot IgG was negative, with all ten antibody bands returning as absent. J.L.’s PCRs for both Babesiosis and Bartonellosis were negative. Dr. Anastasio testified that he did not believe that J.L. had either Lyme disease or Babesia. His testimony was persuasive, and is credited. Dr. Anastasio testified that, given W.L.’s history of a tick bite followed by a rash, there was at least a basis to believe his symptoms could be an indication of Lyme disease. The tick bite and rash were approximately six months prior to W.L. presenting to Dr. Anastasio, and almost three months prior to Dr. Lentz ordering tests for him. Given these time frames, there was plenty of time for W.L. to develop antibodies to Lyme disease if he was in fact infected with the disease. Dr. Anastasio testified that at the time he saw W.L., W.L.’s symptoms were not consistent with late Lyme disease. Dr. Anastasio ordered several tests for W.L., including a Lyme Western blot, a PCR for Babesiosis, a blood smear for Babesiosis, and a PCR for Bartonellosis. The Western blot test was negative, with zero out of ten antibodies present. Both PCR tests and the blood smear were also negative. Dr. Anastasio concluded that W.L. did not have Lyme disease, Babesiosis, or Bartonellosis, and his testimony to that effect is credited.11/ Respondent failed to meet the applicable standard of care with respect to the care and treatment of patients W.L., J.L., and D.D. Based on the credible testimony of Drs. Powers and Robbins, Dr. Lentz departed from the standard of care in ordering tests for all three patients when he did so without seeing them, taking a history with respect to any of them, or conducting a physical examination of any of them to determine whether any of the requested tests were warranted or even justified. Respondent also departed from the applicable standard of care when he ordered tests that would not even assist in diagnosing Lyme disease, Babesiosis, or Bartonellosis had testing for those conditions been appropriate. Moreover, Dr. Powers testified credibly that the appropriate way to order tests for a suspected condition is to use the symptoms that are being investigated by the physician ordering the test, as opposed to the suspected disease being considered. For example, one ordering a mammogram would list “screening” or “diagnostic,” not “breast cancer,” because at that point, breast cancer has not been, and might never be, diagnosed. Documenting the symptom as opposed to the disease is important in terms of continuing care, so that there is no confusion by a subsequent health care provider reading the records about a premature diagnosis. Dr. Powers’ testimony is credited. Dr. Lentz also claimed that because J.L., W.L., and D.D. were not his patients, he did not need to have medical records for them that complied with section 458.331(1)(n). However, Dr. Lentz created patient records for all three in order to order the laboratory tests for them. He coded the action taken as having high complexity. The definition of medicine includes “diagnosis, treatment, operation, or prescription for any human disease, pain, injury, deformity, or other physical or mental condition.” § 458.305(3), Fla. Stat. Respondent clearly engaged in the practice of medicine when he wrote prescriptions for tests for the purpose of diagnosing disease. By ordering these tests, creating medical charts for them (however limited they may be), interpreting the test results and communicating those results, he established a physician-patient relationship with J.L., W.L., and D.D. Accordingly, he was required to have patient records that justified the course of treatment (here, the diagnosis of Lyme disease, Babesiosis, and Bartonella). The records presented do not meet that requirement. DOAH Case No. 15-2890PL; DOH Case No. 2012-01987 (Patient C.H.) At the time of the events giving rise to this case, C.H. was a 23-year-old woman. She was married and attending her final year of chiropractic school in Kennesaw, Georgia. C.H. testified that in December 2010, she had experienced a bout with the flu, including an episode where she passed out in the shower, for which she was prescribed a Z-pack, and recovered. She then had gum surgery during the Christmas break, requiring anesthesia, after which she visited her husband’s family in Missouri over the Christmas holiday. After C.H. returned to Georgia, she returned to class for the spring semester. In early February of 2011, she had an episode in class where her heart started beating very rapidly, and upon a physician’s advice, went to the emergency room. Tests given there were normal. Follow-up tests also did not reveal the basis for her symptoms, and in March 2011, her mother contacted Dr. Lentz based upon the suggestion of a family friend who had treated with him. On or about March 20, S.H. contacted Respondent by e-mail regarding her 23-year-old daughter, C.H. S.H. had been referred to Respondent by a family friend. S.H. reported that she had found a checklist for Lyme disease symptoms online, which included some of the symptoms her daughter was experiencing, such as fatigue, rapid heartbeat, chest pain, headaches, blurry vision, and difficulty concentrating. She also related that C.H. was in her final year of chiropractic school and had recently completed her national boards, and thought that some of the symptoms might be related to stress and anxiety from her studies. In that e-mail, S.H. reported to Respondent that C.H. had tested negative for Lyme disease the previous week. Respondent received a copy of C.H.’s negative Lyme disease test report from blood collected on or about March 16, 2011. On or about March 22, 2011, Respondent documented his assessment of C.H. as Lyme disease and chronic fatigue syndrome. He ordered CD57, C3a, C4a, and ECP laboratory tests of C.H.’s blood. At the time these tests were ordered, Respondent had not seen or talked to C.H., taken her history, or performed a physical examination. Respondent did not at any time prescribe an ELISA test or Western blot test for C.H. On April 14, 2011, S.H. e-mailed Dr. Lentz to see if any test results had been received for C.H. Dr. Lentz replied, “CD57 51+ positive for Lyme. Babesia is negative at this time.” When asked how to proceed, he told her she needed to start treatment until the CD57 is over 120.12/ S.H. asked via e-mail whether C.H. should get treatment from Dr. Lentz or her family doctor, saying they would prefer to work through him, as this is his specialty. Dr. Lentz responded, “This is more than a good family physician can handle. I have 35 years of family practice and know first hand. Lyme is a multi-faceted problem and requires extra time and effort to educate and direct this complex problem.” On or about April 18, 2011, Respondent prescribed the antibiotics Omnicef (cefdinir) and azithromycin to C.H. At the time he prescribed these medications, Respondent had not seen C.H., and there is no documentation in the patient records that Respondent made any inquiry regarding potential allergies before prescribing these antibiotics. On or about April 25, 2011, C.H. presented to Respondent for the first, and only, office visit. The medical records for that date contain symptoms that C.H. credibly denies having reported to him, such as double vision, twitching, tremors and shakes, explosive (behavior), and shortness of breath. C.H. does not recall being weighed at that visit, although the record contains a weight for her. It does not however, indicate her temperature, pulse, or respiration rate. She recalls a minimum examination for which she remained clothed in shorts and a t- shirt. During the examination, Respondent asked if she had ever been bitten by a tick or had a rash, and checked some areas of her body for a tick bite/rash, which she denied ever having. Dr. Lentz did not inquire about her travel history. Despite the fact that one of her symptoms was the inability to take a deep breath and had suffered from heart palpitations, his patients do not reflect a temperature, pulse, or respiration rate. At that visit, Respondent added the antibiotic Flagyl (metronidazole) and Interfase Plus Prothera, an enzyme formulation, to C.H.’s medications. C.H. testified that at that visit, Dr. Lentz told her that he was a specialist with numerous years of experience, and that he was the only one certified to be able to treat this, and she would have to be under his constant care. C.H. also testified that he told her she would need to be medicated for the rest of her life, because Lyme disease lives forever in your body, and that she would probably never be able to get pregnant or have children. C.H. was devastated by this information. The entire visit with Dr. Lentz, including both the taking of her history and the physical examination, lasted approximately ten minutes. C.H.’s testimony is credited. On or about June 10, 2011, Respondent prescribed CD57, C3a, C4a, and ECP tests for C.H. On or about July 2, 2011, Respondent prescribed C.H. with Babesiosis. He made this diagnosis completely on the basis of test results, as C.H. had not returned to his office after her first and only visit. On or about July 9, 2011, Respondent added artemisinin (an antimalarial), Hepapro (a nutritional supplement); Mepron (atovaquone, an antiparasitic), heparin injections (an anticoagulant), magnesium oxide (antacid, laxative, dietary supplement), and omega-3 fatty acids to C.H.’s treatment. Respondent did not prescribe a blood smear examination for Babesial parasites or PCR amplification for Babesial DNA for C.H. At no time during her treatment did Dr. Lentz refer C.H. to a specialist. Indeed, he represented to her and to her mother that he was a specialist in Lyme disease and that he was better equipped to treat these conditions than a normal family practitioner would be. C.H.’s condition worsened rather than improved under the medication regimen Dr. Lentz prescribed. She suffered diarrhea and blurred vision and her other symptoms did not improve. Dr. Joel Rosenstock is a medical doctor licensed to practice medicine in the State of Georgia. He is board certified in internal medicine with a subspecialty in infectious disease, and has practiced infectious disease medicine for over 30 years. During the time related to this proceeding, Dr. Rosenstock was practicing in Atlanta, Georgia, at the AbsoluteCARE Medical Center and Pharmacy. C.H. first presented to Dr. Rosenstock on July 12, 2011, at which time she reported Dr. Lentz’s diagnoses of Lyme disease and Babesiosis. In contrast to her brief visit with Dr. Lentz, her consultation with Dr. Rosenstock lasted two to three hours. Dr. Rosenstock immediately ordered a Western blot test for C.H., which was negative. He conducted a thorough history and physical for her, and asked C.H. questions about her travel history, her dogs and where they slept, her hobbies, etc. He advised her that he did not believe that she had Lyme disease or Babesiosis, and recommended that she stop all of the antibiotics and other medications that Dr. Lentz had prescribed. He warned her that it could take several months before the drugs were out of her system, so relief from the side effects would not be immediate. Within a few weeks of stopping the medications, C.H. was feeling much better and was on her way to feeling back to her old self. Dr. Rosenstock did not believe that any of the tests that Dr. Lentz ordered for C.H. were useful in diagnosing Lyme disease or Babesiosis, and did not believe that heparin served any purpose in treating C.H. Based on the credible opinions of Drs. Powers and Robbins, and the testimony of Dr. Rosenstock as a subsequent treating provider, it is found that Dr. Lentz departed from the applicable standard of care in the care and treatment of C.H. in several respects. First, Respondent departed from the applicable standard of care by ordering blood tests and prescribing antibiotic treatment for C.H. (as well as other medications) when he had never actually seen her. At the time he ordered the blood tests, and at the time he first ordered medications for C.H., he had not obtained a history for her, much less a history that was suggestive of Lyme disease, and had not conducted a physical examination of any kind. All he had as a basis for ordering tests was the e-mail from her mother. This e-mail was an insufficient basis upon which to determine that testing for Lyme disease was warranted. When he did actually see C.H., he failed to perform an adequate physical examination and failed to take an adequate history that included travel history, possible exposure to ticks, how long any tick bite may have lasted, and the size and appearance of the tick. Respondent failed to use the generally accepted tests for the diagnosis of Lyme disease and Babesiosis, instead relying on tests that are meant for investigational purposes and indicate on their face that they are not meant for diagnostic purposes. Moreover, as noted above, at the time he ordered the tests, he had no basis upon which to believe C.H. had Lyme disease. Although even his own expert witness consistently stated that a diagnosis of Lyme disease is based in large part upon a thorough history, here, Dr. Lentz had no history. Dr. Cichon’s testimony that it was appropriate to rely on the information in S.H.’s e-mail about her daughter’s symptoms (keeping in mind that her daughter is an adult, not a child) is rejected as not credible. Respondent also departed from the applicable standard of care by prescribing Omnicef, azithromycin, artemisinin, Hepapro, Mepron, heparin injections, magnesium oxide, and omega-3 fatty acids for a condition that she did not have. Given that C.H. had no condition justifying the prescription of these drugs, the prescriptions were both inappropriate and excessive. They also were prescribed for a duration that was not justified, and exposed C.H. to complications that were unnecessary. Respondent was required to keep medical records that justified the course of treatment. His medical records for C.H. fell well short of this requirement. He failed to document a complete history, an adequate physical examination, or why he did not refer her case to a specialist. He also departed from the applicable standards when he used a diagnosis of Lyme disease as the basis for blood tests at a time when he had never seen the patient. Failure to Timely Report Diagnoses or Suspicion of Lyme Disease to the Department of Health (DOAH Case Nos. 15-2889 and 15-2890) Finally, in DOAH Case Nos. 15-2889 and 15-2890, the Department alleged that Respondent failed to report his diagnoses of Lyme disease or suspicions of Lyme disease for patients D.H., J.L., W.L., S.L., D.D., and C.H. to the Department of Health. Section 381.0031, Florida Statutes (2010-2011), requires certain licensed health care practitioners and facilities in Florida to report the diagnosis or suspicion of the existence of diseases of public health significance to the Department of Health. Lyme disease is one of the diseases identified by rule that meets the definition of a disease that is “a threat of public health and therefore of significance to public health.” § 381.0031(2), Fla. Stat.; Fla. Admin. Code R. 64D-3.029. There are forms that are identified by rule for use in reporting these cases. Fla. Admin. Code R. 64D-3.030(3). Ashley Rendon is a biological scientist for the Department of Health in Okaloosa County. Ms. Rendon is an epidemiologist whose duties include investigating reportable disease conditions and outbreaks of public health significance in Okaloosa County. According to Ms. Rendon, whose testimony is consistent with the Department’s rules on this subject, all diagnosed or suspected cases of Lyme disease must be reported to the Department. Once reported, the county health office will conduct an analysis of the reported diagnosis or suspicion, based on a “guidance to surveillance” document, to determine whether the reported case meets the definition for Lyme disease such that the case needs to be reported to the statewide system and to the CDC. Ms. Rendon testified that whether a suspected case or a diagnosis meets the case definition is not for the practitioner to decide. Ms. Rendon’s testimony is credited. According to Ms. Rendon, the Department maintains records both for those reported cases that met the case definition and those reported cases that did not. For 2010, there was one case of Lyme disease that was confirmed, probable, or suspect. None were reported for 2011. There were seven to eight additional cases that were reviewed, but not reported as probable, confirmed, or suspect. Not all reported results are confirmed by ELISA or Western blot. Ms. Rendon reviewed the records of the Department to determine whether Dr. Lentz had reported any cases of Lyme disease, whether suspected or diagnosed, to the Department. There was one instance where a patient of Dr. Lentz’s apparently called in and asked questions, but there was no record of Dr. Lentz or anyone in his office reporting Lyme disease. Dr. Lentz claimed that he had at least on one occasion attempted to report in the past, but that he could not say if he had reported any of the patients named in the Administrative Complaints. He claimed that the Department would not accept reports that are not supported by two-tier testing results, so he stopped trying to report. His claim is rejected as not credible. There is clear and convincing evidence to establish that Respondent failed to report his diagnoses of Lyme disease for patients D.H., J.L., W.L., D.D., S.L., and C.H. General Observations Of the seven patients presented in this proceeding, Dr. Lentz saw only two before ordering tests for Lyme disease and in some cases, Babesiosis or Bartonellosis. With respect to C.H., not only did he fail to see her before ordering testing, but he ordered medications for her without ever obtaining a medical history or performing a physical examination. Some of the patients specifically requested testing for Lyme disease. However, it is the physician’s responsibility to determine whether there is any realistic reason to believe that a patient has a need for such tests. Moreover, in several instances, the general, non-specific symptoms related by the patients suggest several other alternative conditions that could cause the patients’ problems. Even Respondent’s expert opined that Lyme disease, Bartonellosis and Babesiosis share a lot of general, non-specific symptoms with other illnesses, including serious diagnoses such as ALS, MS, and rheumatoid diseases. These are all, according to Dr. Cichon, differential diagnoses that a physician should sometimes consider when trying to find a diagnosis. Yet with all of these patients, Dr. Lentz went straight to Lyme disease every time. He did not consider much of anything else when even to a lay person, the records cry out for a more thoughtful and measured approach. In short, it seems that Dr. Lentz wanted to find Lyme disease regardless of the symptoms presented, and so he did. By doing so, he cost these patients not only the money used for testing and, with respect to C.C., W.L., S.L., and C.H., subjecting them to treatments they did not need and, in at least with respect to S.L., could not afford, but he subjected them to a treatment regimen that made them miserable, was of questionable benefit, and exposed them to unnecessary risks. Petitioner presented the expert testimony of Dr. Charles Powers, a general family practitioner, and Dr. William Robbins, an infectious disease specialist. It also presented the testimony of subsequent treating physicians: Dr. Janelle Robertson, Dr. Patrick Anastasio, and Dr. Joel Rosenstock. Each subsequent treating physician testified credibly that the symptoms presented simply did not justify a diagnosis of Lyme disease, and the testing they either conducted or reviewed did not indicate a basis for such a diagnosis. Their testimony was consistent with that of both expert witnesses presented by the Department, and the testimony of these subsequent treating physicians and expert witnesses have been accorded great weight. Respondent presented the testimony of Dr. Michael Cichon, a retired infectious disease specialist. Dr. Cichon’s testimony was in many respects inconsistent, and at times he seemed to be struggling to actually support the care and treatment that Respondent performed in these cases. While he championed Respondent’s use of the CD57, the ECP, and the Fry test, he also admitted that he seldom, if ever, used some of these tests, and that there were problems with standardization of the tests. Moreover, the tests themselves indicated on their face that they were for investigational, as opposed to diagnostic, use, and should not be used as the sole basis for diagnosis of patients. Because of the significant inconsistencies with his testimony and the contrasts between what he advocated and what Dr. Lentz sometimes did, his testimony is given little weight.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding that Respondent has violated section 458.331(1)(g), (m), and (t), as alleged in the three Administrative Complaints at issue in this proceeding; and by the findings that Respondent violated section 458.331(1)(t) with respect to all seven patients, Respondent is guilty of repeated malpractice. It is further recommended that the Board of Medicine revoke his license to practice medicine in the State of Florida, impose an administrative fine in the amount of $30,000, and impose costs pursuant to section 456.072. DONE AND ENTERED this 8th day of July, 2016, in Tallahassee, Leon County, Florida. S LISA SHEARER NELSON 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 8th day of July, 2016.
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 for determination at formal hearing was whether Respondent committed the offenses set forth in the administrative complaint, and, if so, what action should be taken.
Findings Of Fact The Department of Professional Regulation (now, the Agency for Health Care Administration), Board of Medicine (Petitioner), is the state agency charged with regulating the practice of medicine pursuant to Section 20.30, Florida Statutes, and Chapters 455 and 458, Florida Statutes. At all times material hereto, Arthur J. Schatz, M.D. (Respondent), has been a licensed physician in the State of Florida, having been issued license number ME 0024745. On or about September 7, 1988, Patient A. H., a 61-year-old female, presented to her internist with complaints of left pelvic pain. The internist ordered a pelvic sonogram and an MRI. Both procedures revealed a five centimeter mass on the left side of Patient A. H.'s pelvis. The internist referred Patient A. H. to Respondent. On or about September 16, 1988, she presented to Respondent who performed an examination by palpation, which revealed a mass on the left side of her pelvis. Respondent diagnosed Patient A. H. as having a left ovarian tumor. Respondent scheduled Patient A. H. for exploratory laparotomy and probable total abdominal hysterectomy and bilateral salpingo-oophorectomy. Exploratory laparotomy is a surgical procedure in which a patient's abdomen is opened to explore the abdominal cavity in order to determine whether there is any pathology present. Exploratory laparotomy was indicated, and Respondent was qualified and credentialed to perform the surgical procedure. Because of the location of the mass and because of Patient A. H.'s history, especially her age, pre-operatively, Respondent believed that the mass was highly suggestive of a malignancy. Respondent did not perform or order any other diagnostic test or seek any consultation with any other physician or any specialist. Such conduct by Respondent was within the acceptable standard of care, skill, and treatment in the practice of medicine. On or about September 25, 1988, Respondent admitted Patient A. H. to Parkway Regional Medical Center for the surgical procedure to be performed. On or about September 26, 1988, Respondent performed the exploratory laparotomy. Upon entering Patient A. H.'s abdomen, Respondent took washings. Respondent then proceeded to examine her female organs and discovered that they were normal. Continuing, Respondent palpated the mass on the left side of Patient A. H.'s pelvis in the retroperitoneal area, behind a very thin layer of tissue called the peritoneum. Pre-operatively, Respondent could not have known that the mass was retroperitoneal. The overwhelming majority, ninety-eight percent, of gynecologic surgery is performed on the intra-peritoneal structures, while only two percent is performed retroperitoneally. General gynecologists are trained to and do perform surgical procedures retroperitoneally. Respondent appropriately elected to open the peritoneum and entered the retroperitoneal space to identify and surgically address the area of suspected pathology. He found a somewhat soft mass, approximately five centimeters in diameter, on the pelvic side wall with a white structure running through the middle of the mass. The mass, a tumor, which was encapsulated was round in shape and yellowish in color. Encapsulation is more commonly associated with benign tumors than malignant tumors. Unsuccessfully, Respondent attempted several times to dissect the mass off the white structure. Respondent recognized the white structure as the obturator nerve which was later identified as such. Respondent observed that the mass had the general appearance of a lymphoma which is a benign, fatty, slow-growing tumor. However, he was unable to precisely identify the nature of the mass which could also have been lymphosarcoma, malignant, since no analysis had been performed on the mass. Respondent believed that the tumor was more likely benign than malignant. Confronted with a most unusual situation in that the tumor was in a very unusual location and the obturator nerve was within the mass itself, Respondent requested that the entire hospital be paged for a gynecologic oncologist. He was informed that neither of the two gynecologic oncologists on the hospital staff were in the hospital or scheduled to be in the hospital. Respondent's act of not having a gynecologic oncologist present or on call during the scheduled surgery was not practicing medicine below the acceptable standard of care, skill, and treatment. Respondent then requested the paging of a general surgeon. A board certified general surgeon responded and entered the operating suite where Respondent was operating on Patient A. H. The general surgeon did not scrub to assist Respondent but came into Respondent's operating suite and viewed the operating field. He advised Respondent that he had never seen a condition like that of Patient A. H. and could offer no suggestions. Getting no assistance from the general surgeon, Respondent requested that a neurosurgeon or orthopedist be called. A board certified orthopedist was in surgery in an adjacent operating suite. Respondent broke scrub, left his operating suite and entered the orthopedist's operating suite. He questioned the orthopedist regarding the function of the obturator nerve and the anticipated effect of sacrificing the nerve, if that were necessary, in order to remove the tumor in its entirety. The orthopedist advised Respondent that the obturator nerve was a major nerve which governs the muscles involved in the adduction of the thigh and affects the ability to walk. He further advised Respondent that sacrificing the nerve should result in only a minimal disability which could be adequately addressed with physical therapy. Generally, a general gynecologist, including Respondent, has a cursory understanding of the function of the obturator nerve. Arising from the lumbar section of the spinal column, the obturator nerve is a major nerve and is extremely important in allowing a person's legs to move to the midline for the purpose of walking. After being advised by the orthopedist, Respondent re-scrubbed and returned to his operating suite. He again attempted, without success, to dissect the tumor from the obturator nerve. Thereupon, Respondent decided that Patient A. H. would benefit from a complete resection of the tumor even though it would mean sacrificing the obturator nerve in order to remove the tumor in its entirety. He had no experience in the removal of lymphomas from nerves. Respondent appropriately decided against performing a frozen section on the tumor, prior to removal, because such a procedure might expose Patient A. H. to the risk of cancer cells being spread through the retroperitoneal space if the tumor was malignant. His action was within the acceptable standard of care, skill, and treatment in the practice of medicine. A frozen section is a procedure in the intraoperative period 2/ in which a surgeon attempts to remove a piece of a tumor or mass to send to a pathologist to determine whether the mass is malignant or benign. The procedure is important because it provides the surgeon with direction as to how to proceed in terms of treatment and care of a patient while the patient is under anesthesia and in the operating room. Furthermore, Respondent appropriately decided against removing only portions of the tumor, thereby leaving some of it behind, because such a procedure could result in the tumor re-growing, and possibly as a malignancy. His action was within the acceptable standard of care, skill, and treatment in the practice of medicine. Respondent removed the tumor in its entirety which included removing the portion of the obturator nerve to which the tumor was attached to and incorporated within the tumor. Respondent sent the specimen to the pathology lab for analysis which revealed that the tumor was a fatty, benign lymphoma and that the white structure incorporated within the tumor was nerve tissue. Prior to removing the tumor in its entirety, there was no acceptable method available to Respondent for him to definitively know that the tumor was benign. Respondent failed to record his contacts with the general surgeon and the orthopedic surgeon in his operative notes for the surgery but recorded the contacts in his discharge summary. It is customary and appropriate to record intra-operative consultations in an operative report. Neither the general surgeon nor the orthopedist considered their contact with Respondent as a consultation. Patient A. H.'s postoperative recovery was not as anticipated in that she suffered severe, instead of minimal, disability which has affected her ability to walk. She is unable to walk without the assistance of either a cane or a leg brace. No literature or authority exists which supports the sacrifice of the obturator nerve for a benign tumor or a tumor which appears to be benign. Patient A. H.'s condition was a rare case because of the location of the tumor and because the tumor was attached to the obturator nerve which was incorporated within the tumor. Neither the expert for Petitioner nor for Respondent had ever experienced, or heard or read of such a situation. Furthermore, because of Respondent's experience with Patient A. H. and her resulting condition, both experts have greater knowledge of the obturator nerve. Respondent's removal of the tumor in its entirety, including removing a portion of the obturator nerve, was within the acceptable standard of care, skill, and treatment in the practice of medicine.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency For Health Care Administration, Board of Medicine, enter a final order dismissing the administrative complaint. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 2nd day of December 1994. ERROL H. POWELL Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 2nd day of December 1994.
Findings Of Fact Based upon the oral and documentary evidence adduced at the final hearing and the entire record in this proceeding, the following findings of fact are made: At all time pertinent to this proceeding, Respondent, Jules G. Minkes, was licensed as an osteopathic physician in the State of Florida having been issued license No. OS 001516. There is no evidence that Respondent has ever been the subject of prior disciplinary action by the Petitioner, Department of Professional Regulation, and/or the Board of Osteopathic Medical Examiners. Respondent is certified by the American College of Osteopathic Internists, the American College of Osteopathic Board of Cardiology, the American Osteopathic Board of Nuclear Medicine and the American Board of Nuclear Medicine. Respondent has no advanced or specialized training in dermatology, however, he did complete courses in dermatology as a student and, as part of his primary care practice, he does provide some minor dermatological treatments. At all pertinent times, Respondent was the medical director of South Dade Osteopathic Medical Center d/b/a Suburban Medical Center ("Suburban"). Suburban was a primary care provider facility with International Medical Center ("IMC"), a health maintenance organization ("HMO"). Suburban contracted to become part of the IMC HMO system beginning in June of 1981. Under the IMC system, a patient's primary care physician was the "gatekeeper" four medical services. In the absence of an emergency, a patient was required to first see his primary care physician in order to be referred to other specialized medical care. Conflicting evidence was presented regarding the operation of the IMC program and the procedures for referring patients to specialized medical care and/or physicians who were not part of the HMO network. The IMC referral procedures and the manner of allocating the costs of specialized treatment were not the same at all IMC facilities and were changed several times during the early and mid 1980's. (Certain pertinent aspects of the referral process are explored in more detail in Findings of Fact 37 below.) IMC developed a network of physicians to whom primary care physicians could refer patients for specialized medical treatment. In accordance with its IMC contract, Suburban was expected to provide all primary medical care for all IMC patients assigned to the center. Respondent and Suburban agreed to refer IMC patients to specialists, hospitals, etc. within the IMC network "unless approval for a nonparticipating facility or a professional is specifically approved by the medical director or executive director of IMC." At all times pertinent to this proceeding, Respondent referred his HMO patients to the IMC specialist network with the expectation that those specialists would either treat the patient or further refer them as necessary. Some IMC affiliated providers entered into "risk" contracts with IMC and were responsible for paying specialists and/or directly negotiating arrangements for those specialists to be compensated. The evidence established that, during the time that the Patient was treated at Suburban, Suburban did not have a "risk" contract with IMC. As set forth on page 4 paragraph 23 of the contract between Suburban and IMC (Respondent's Exhibit 3) IMC paid the specialists attending to Suburban's HMO Medicare patients. In accordance with Suburban's contract, IMC allocated a specific amount per member per month to be deposited into an account and applied towards payments of the specialists. At the end of each quarter of the calendar year, IMC was supposed to distribute any sums remaining in the specialists' account to Respondent. However, during the time the contract was in effect, there were never any funds remaining in the specialists' account at the end of any calendar quarter. Therefore, no funds from this account were ever distributed to Respondent. IMC developed a plan for treating Medicare eligible patients. This program was known as the Gold Plus Plan and required the patient to essentially assign their Medicare benefits to the HMO. All patients who enrolled in the Gold Plus Plan executed an agreement acknowledging that all non-emergency medical treatment had to be provided or arranged for by IMC and that they would be limited to seeing doctors within the IMC network. All patients were advised that they could see a specialist at their own expense or could disenroll from the HMO at any time and return to their prior Medicare status. The Patient, T.G., enrolled in the IMC Gold Plus Plan in July of 1982 and executed the standard agreement. At the time she was first seen at Suburban, T.G. was approximately 68 years old. She was a somewhat difficult patient who frequently complained of numerous minor ailments. In approximately 1978, while she was living in New York, T.G. had a basal cell carcinoma removed from her forehead by a dermatologist. T.G. and her husband, C.G., moved to Florida in approximately 1978. Shortly thereafter, additional lesions appeared on her forehead. The Patient's family physician at the time, Dr. Kenneth Hertz, referred T.G. to a dermatologist, Dr. Darrell Blinski, who biopsied the lesions in August of 1981. The pathology report from the biopsy contained a diagnosis of "basal cell carcinoma; both side margins are involved. The deep margin is clear." Involvement of the surgical margins of a biopsy indicates the basal cell carcinoma has spread to the limits of the biopsy and perhaps beyond. On August 22, 1981, T.G. was admitted to coral Reef General Hospital where Dr. Blinski attempted to excise the basal cell carcinoma and performed a Limberg flap procedure to cover the skin defect on her forehead. As a result of the procedure, the Patient had a noticeable scar in the middle of her forehead. Dr. Blinski's admission notes in connection with this August 22, 1981 procedure indicate T.G. had: ... a history of multiple recurrences of basal cell carcinoma of the forehead under treatment in New Jersey and down here... incisional biopsy of a central forehead lesion was done and returned as a basal cell carcinoma, margins involved. The area in question wad in the central forehead. The physical examination revealed an ulcerated lesion measuring 2 mm x 5 mm in the central forehead with a scarred area to the left of that measuring 4 mm in diameter. Involved skin is within 1 cm. Examination of the rest of the facial skin was negative for lesions. A pathology report dated August 27, 1981 on tissue removed during the procedure performed by Dr. Blinski revealed basal cell carcinoma with the "left lateral margin free of tumor, all others surgical margins involved with tumor." In other words, not all of the tumor was removed during the surgery by Dr. Blinski. Dr. Blinski referred the Patient to Dr. Henry Menn for consultation. Dr. Menn was a professor of dermatology and head of the Mohs chemosurgery unit at the University of Miami. In a letter dated September 21, 1981, Dr. Menn advised Dr. Blinski that he thought: It would be best to initiate Mohs Chemosurgery excision of the residual basal cell carcinoma discovered by you in the surgical margins of your excised specimen performed on 27th of August, 1981, from tissue removed from the forehead. In approximately four weeks inflammation and irritation normally present after a surgical flap procedure will be reduced and the chemosurgical excision will be more easily accomplished. Dr. Menn apparently changed his treatment plan for the Patient because, instead of undertaking chemosurgery, he simply followed the patient clinically until the summer of 1982. During that time period, there were no clinical signs of regrowth of the basal cell carcinoma. While primary basal cell carcinoma typically grows in little mounds of cells, recurrent basal cell carcinoma can grow in a different, infiltrative fashion. This type of growth tends to be more subtle and the skin can appear normal for extensive periods of time. T.G. returned to Dr. Menn on December 17, 1981 and, in a letter dated December 21, 1981, Dr. Menn advised Dr. Blinski that: ... about four months have now passed since you excised the large basal cell carcinoma on her forehead. There is no clinical evidence of regrowth of tumor even though the surgical excision margins were involved by tumor after your treatment. Close clinical inspection and palpation do not reveal the evidence of basal cell carcinoma at this time... I will continue to follow the patient at periodic intervals. If there is any evidence of malignancy, I will do an excisional biopsy and initiate chemosurgical treatment as indicated. On March 15, 1982, Dr. Blinski examined the patient and advised Dr. Menn by letter that "there is no recurrence as of this time. She will be followed in four months." By letter dated May 19, 1982, Dr. Menn advised Dr. Blinski "I re- examined our patient [T.G.] on the 18th of May, 1982. I am pleased to report that there is no evidence of regrowth of the skin cancer were [sic] you performed plastic surgery on her forehead... I will continue to follow the patient." On July 22, 1982, T.G. and her husband joined the IMC Gold Plus Plan. Because the Gold Plus Plan required the enrollees to assign their Medicare benefits, T.G. stopped seeing Dr. Menn at this time. T.G. had an appointment with Dr. Menn on October 7, 1982. Dr. Menn's notes indicate that the patient did not appear for her appointment and there is a notation that the "patient wishes to continue care in her HMO." Suburban was the HMO affiliate center to which T.G. was assigned. T.G.'s first visit to Suburban took place on September 3, 1982. During that visit, T.G. advised the Respondent that she had a history of skin cancer. During the physical examination of the Patient, the Respondent noted the scar on her mid-forehead. At the time of the Patient's initial visit to Suburban, the medical records of her prior treatment by Dr. Blinski and Dr. Menn were not available. At some point, those records were obtained by the Respondent. However, it is not clear when the records were received. T.G.'s second visit to Suburban was on September 17, 1982. There is no indication in the medical records of that visit that her forehead was examined. On October 4, 1982, T.G. returned to Suburban and complained to Respondent that her "forehead always feels hot." The Respondent noted a "small left papular swelling 4mm at lower portion of scar-subcut." Under the "assessment" portion of his medical form, Respondent wrote "(1) follow possible recurrence basal cell carcinoma-left lower forehead (2) 1-2mm lesion on right forehead (3) keratotic lesion-right arm." During the October 4, 1982 visit, Respondent hyfercated the lesions on the Patient's right forehead and right arm. Hyfercation is an electrocauterization that burns or desiccates skin lesions by removing the water content of skin cells. Hyfercation destroys tissues and, as a result, the tissue cannot be pathologically diagnosed unless a biopsy is first taken. No biopsy was taken prior to the hyfercation of either of the lesions. Although Respondent has no specialized training in dermatology, he regularly hyfercates skin lesions as part of his office practice. Respondent believes that he has the ability to differentiate between minor, obviously benign skin lesions and those that are more questionable and should be referred to a dermatologist. Respondent noted on the medical records from this visit to "follow for excisional biopsy." That comment was made with respect to the lesion on the Patient's lower left forehead. That lesion was not hyfercated. Instead, the Respondent decided to refer the Patient to a dermatologist in the IMC system for the treatment of that lesion. On October 14, 1982, the Respondent signed the referral form for T.G. to go to the IMC Dermatology Center at a facility known as the Westchester Clinic. An appointment with the IMC dermatologist was scheduled for October 21, 1982. On that day, the Patient was seen by Dr. Seymour Munzer, a dermatologist affiliated with IMC. The exact nature of Dr. Munzer's business relationship with IMC was not established, but he apparently traveled to various IMC Centers to treat patients. During the October 21, 1982 visit, Dr. Munzer noted the Patient's history of surgery for basal cell carcinoma with Dr. Blinski. He noted some nodular firmness above the left brow. His diagnostic impression was "(1) prob. [sic] scar tissue (2) r/o [rule out] recurrent basal cell carcinoma." Patient stated on several occasions that she did not like Dr. Munzer and wanted to see Dr. Menn, her options under the Gold Plus Plan were fully explained to her and she was advised that, under that plan, her treatment would have to be coordinated through the IMC dermatologist. She was also advised that she could see Dr. Menn at her own expense or disenroll from the program and continue her care under traditional Medicare procedures. The Respondent never completed any additional dermatological referral forms for the Patient. While Dr. Munzer claims that a written referral from the primary care physician was necessary every time a patient returned to see him, this testimony is rejected. The more creditable evidence established that Respondent was not required under the IMC system to issue a referral for each visit by a Patient to an IMC specialist. Dr. Munzer biopsied the lesion over the Patient's left brow and submitted it for pathological diagnosis. The pathology report was returned on October 26, 1982 and indicated "basal cell carcinoma, infiltrating. Surgical margins involved by the lesions." T.G. returned to Suburban on November 3, 1982. The records of that visit indicate that the Respondent was waiting for the pathology report. For his assessment, Respondent noted "r/o [rule out] basal cell carcinoma forehead." Respondent's plan was to "follow path report Westchester Center." During the November 3 visit, Respondent removed a 1mm keratotic lesion from the Patient's lower right chin. The Patient returned to Suburban on November 23, 1982. By that time, Respondent had received a copy of Dr. Munzer's report and the pathology report on the biopsy performed by Dr. Munzer. The Respondent discussed the results of the biopsy with the Patient and her husband and explained that she needed to follow up with the dermatologist. While the Patient and her husband have testified that the Respondent advised them that he could treat her basal cell carcinoma, this testimony is rejected. The more creditable evidence established that the Respondent advised the Patient of her need for follow-up by a dermatologist. The Respondent discussed the results of the biopsy with Dr. Munzer by phone and it was his understanding that Dr. Munzer would continue to follow the Patient and provide whatever additional treatment was necessary. The Respondent never received any additional reports or correspondence from Dr. Munzer regarding the Patient. Because the IMC specialists rotated between several hospitals, there was often alot of confusion regarding the paperwork for those patients referred to specialists. It was not unusual for there to be significant delays between the time an IMC specialist saw a patient and the time the specialist's report was sent to the primary care physician. In fact, in many instances such reports were never received. Thus, while Respondent did not receive any further reports from Dr. Munzer, Respondent thought Dr. Munzer and/or IMC was providing treatment for the Patient's basal cell carcinoma as diagnosed in the October 26, 1982 pathology report. No records of the treatment rendered by Dr. Munzer could be obtained from either Dr. Munzer or the Westchester Clinic where Dr. Munzer treated the Patient. It is not clear whether the Patient ever returned to Dr. Munzer for further evaluation or treatment. 1/ However, it is clear that Respondent and his office staff advised the Patient on several occasions that she needed to follow-up with the dermatologist. While the There is no evidence that Dr. Munzer ever developed a plan for treating T.G. Dr. Munzer could not specifically recall his treatment of this Patient except to review his report and the pathology report in Respondent's records. Dr. Munzer testified that he would not have attempted to treat a patient with recurrent basal cell carcinoma on the face, particularly in the area of scar tissue. Instead, he states that he would have recommended either Mohs chemosurgery, referral to a plastic surgeon or possibly radiation therapy. However, it does not appear that Dr. Munzer ever communicated his reluctance to treat such a condition to the Respondent. As far as the Respondent knew, Dr. Munzer and/or the IMC Dermatology Center were capable of treating this Patient. While Dr. Munzer claimed that he did not have authority to refer a patient from an affiliate center for further follow-up, at the very least his input and recommendation would have been essential to determine how to treat a patient with unique dermatological problems. In this case, it does not appear that he ever provided such a recommendation or opinion. Moreover, while Dr. Munzer contends that the Medical Director of an affiliate center was the only person who could make referrals outside the IMC network, Suburban's contract with IMC required such determinations to be made by the Medical Director of IMC. The evidence established that, under Suburban's contract, once a patient was referred to an IMC specialist for treatment, that specialist and IMC were responsible for determining whether to send the patient for additional consultation to a physician outside the IMC network. At no point during the treatment of this Patient did the Respondent attempt to treat the Patient's known basal cell carcinoma. The Patient was next seen by the Respondent on December 7, 1982. The Respondent noted "basal cell carcinoma left-forehead." There is no indication that the Respondent was attempting any treatment for this problem. The Patient was instructed to return in three months. The Patient was treated by the Respondent on February 1, 16, and March 7, 1983 for various ailments and complaints. There is no mention of the Patient's basal cell carcinoma in the medical records of these visits. On April 1, 1983, the Respondent excised a skin lesion on T.G.'s left shoulder. The Respondent submitted the excised lesion for biopsy and the pathology report stated that there was no evidence of malignancy. There is no evidence in the medical records of the April 1, 1983 report that Respondent treated or discussed the basal cell carcinoma on the Patient's forehead. The Patient returned to Suburban on April 4, 6, and May 2, 1983. She was seen by the Respondent during the April 4 and May 2, 1983 visits. The records of those three visits do not reflect any treatment or discussion of the Patient's forehead. The Patient's next visit to Suburban was on May 24, 1983. During that visit, Respondent noted a "2mm keratotic skin lesion, mid forehead." That lesion was high on the forehead near the hairline. It was not in the scar area or adjacent to the previously diagnosed basal cell carcinoma. The Patient wanted the lesion removed for cosmetic reasons and it was the Respondent's opinion that the lesion was not clinically related to the Patient's previous problems. The Respondent felt that the appropriate treatment was to obliterate the lesion and watch for any recurrence rather than to biopsy such a small lesion which appeared benign. His assessment was "keratosis, possible basal cell carcinoma." He hyfercated the lesion and noted to follow it for healing. Because no biopsy was done on this lesion, there is no pathology report available to establish whether or not this lesion was a basal cell carcinoma. Some of the expert witnesses in this proceeding have testified that the Respondent's failure to biopsy this lesion falls below the standard of care expected of a reasonably prudent physician under similar circumstances. However, that testimony presupposes that the lesions was contiguous or adjacent to the prior problem areas. Moreover, even Petitioner's experts admit that a primary care physician such as Respondent should be able to recognize and distinguish cosmetic skin problems from more questionable problems that need closer scrutiny. There is insufficient evidence to disregard Respondent's clinical diagnosis. Even though the Patient had a history of basal cell carcinoma, it was possible, indeed it is likely, that a patient with her history would develop unrelated cosmetic lesions. At the time that the lesion was hyfercated, the Respondent once again advised the Patient that she needed to continue seeing the dermatologist regarding the previously diagnosed basal cell carcinoma. Sometime during the Patient's visits in April or May of 1983, Respondent became aware that the Patient had not been returning to Dr. Munzer for follow-up care of the basal cell carcinoma of her forehead. Until this time, the Respondent had assumed that the Patient was being treated by Dr. Munzer. The Patient reiterated her dislike for Dr. Munzer and also indicated that she did not like the Westchester facility. The Respondent once again explained her options under the HMO plan and advised her of the need to seek specialized care for her basal cell carcinoma. The Patient did not exercise any of the options explained to her and continued to be treated at Suburban through at least March of 1984. During that time, she was treated for various ailments, but no attempt was made to treat the basal cell carcinoma. The Patient's next visit to Suburban took place on June 1, 1983. In addition to treating other unrelated complaints, the Respondent noted that the wound from the hyfercated forehead lesion was healing. The Patient was also treated at Suburban on June 16 and 21, July 7 and 25, August 1 and 9 and October 17, 1983. The Respondent saw the Patient on all of those visits except for the June 16, July 25, and October 17 visits when she was treated by other Suburban employees. There is no indication in the medical records of these visits that the Patient's forehead and/or basal cell carcinoma were treated. The Patient did not appear for scheduled appointments on June 6, July 18, and August 12, 1983. During a visit on November 1, 1983, the Respondent noted a lesion on the Patient's right forehead. This lesion was not contiguous to the Patient's scar nor was it adjacent to the area biopsied by Dr. Munzer. The Respondent hyfercated this lesion. As with the other lesions that Respondent hyfercated, the hyfercation was performed for cosmetic reasons and not because of any medical necessity. Each of the lesions that were hyfercated healed quickly and completely without any sign of regrowth. Because the lesions were hyfercated, biopsies were not possible. The absence of a pathology report precludes a conclusion that none of the hyfercated lesions were malignant. However, the Respondent's testimony that he only hyfercated lesions in areas where no previous problems had occurred and that appeared clinically benign is accepted. Therefore, there was no deviation from the standard of care expected of a reasonably prudent physician. The Patient returned to Suburban on November 8, and 28, and December 14, 1983 and January 13 and 30, 1984. There is no indication that the Respondent saw the Patient on those visits. The Patient was seen by other physicians employed by Suburban. None of those physicians attempted to treat any skin problems and/or the forehead area of this Patient. There is no indication that any of these physicians noted any abnormality on the Patient's forehead. During those visits when the Respondent saw the Patient, the Respondent would typically check her forehead to determine if there were any changes in the scar or the area that Dr. Munzer had biopsied. No changes were evident until the Patient's visit on February 6, 1984. During the February 6, 1984 visit, the Respondent noticed a slight nodularity on the Patient's forehead. Respondent did not attempt to treat that bump. He again recommended to the Patient that she see the dermatologist. The only notation in the medical records was "follow slight nodularity-forehead-hx [history] basal cell CA." The Patient was instructed to return in two weeks. The Patient returned to Suburban on February 7, 13, 27, and March 14, 1984. The Respondent only saw the patient on the February 13 visit. During these visits, she was treated for various unrelated matters and there is no notation regarding her basal cell carcinoma or the nodularity noted on February 6. On March 7, 1984, T.G. transferred to Dr. C.N. House's IMC affiliated provider center. On her first visit to Dr. House on April 6, 1984, T.G. was referred to a dermatologist, Dr. Kenneth Rosen, for a biopsy of her forehead. At the time of this visit, Dr. House did not have any of the Patient's prior records. Dr. Rosen took biopsies from three areas of the Patient's forehead: one from the "right forehead", one from the "mid-forehead", and one from the "mid-forehead above left side." The pathology reports on all three sections indicated basal cell carcinoma that had been incompletely excised. The multiple sites of carcinoma indicate that the tumor was infiltrating. Dr. Rosen advised Dr. House that he was not qualified to treat the Patient. He advised Dr. House that the Patient needed to be referred for Mohs chemosurgery. At the time, the only physician in Miami that Dr. House knew could perform that surgery was Dr. Menn. Mohs chemosurgery, now known as Mohs micrographic surgery, is the treatment of choice for recurrent basal cell carcinomas because of its high cure rate and conservation of healthy skin. Dr. House's contract with IMC was a "risk" contract. Under that contract, the fees for treatment by specialists were directly deducted from his payment from IMC. Dr. House arranged his own network of specialists to whom he would refer patients. As indicated above, the Respondent's contractual arrangement with IMC was different and, at least during the time this Patient was being treated, Respondent only referred patients to the network developed by IMC. Dr. House arranged for the Patient to be seen by Dr. Menn on May 15, 1984. In making this arrangement, Dr. House agreed to personally assume responsibility for Dr. Menn's fees. T.G. was treated by Dr. Menn at the University of Miami with the Mohs Chemotherapy technique in four stages over a period of three days, May 29, 30, and June 1, 1984. The Mohs Surgery revealed an extensive basal cell carcinoma that covered most of the Patient's forehead area. Extensive skin was removed during the surgery and, in some areas, the surgery penetrated to the underlying bone. The surgery reports indicate that all of the area was one continuous basal cell carcinoma of the forehead, the eyelids and the nasal dorsum. Dr. Garland believes that the basal cell carcinoma treated by Mohs Chemosurgery in May of 1984 was the same tumor present and growing at the time that Dr. Menn was seeing this Patient in 1981 and 1982. After the Mohs Surgery, the Patient was referred by Dr. House to Dr. Gary Zahler, an IMC Plastic Surgeon, for repair by skin grafting of the extensive wound to her forehead. After the surgery, the Patient was followed by Dr. Menn until his death in 1985. Dr. Larry Garland, a colleague of Dr. Menn at the University of Miami and a dermatologist specializing in Mohs Chemosurgery and cutaneous oncology, continued following the Patient after Dr. Menn's death. T.G. died from other causes in 1989. She had no recurrence of basal cell carcinoma following the Mohs surgery. The evidence established that the Respondent is a capable and dedicated physician. There is no evidence that the Respondent manipulated the Patient for his own financial gain. It is clear that at the time this case was initiated, there were some erroneous factual assumptions made by at least one expert retained by the Petitioner. Petitioner sent the Patient's medical records for review by Dr. Joseph Rosen. His opinion served as one of the grounds for the initial finding of probable cause in this case and the subsequent issuance of the Administrative Complaint. That opinion was premised on the erroneous assumption that the Respondent never referred the Patient to a dermatologist for treatment. At the hearing in this cause, Dr. Rosen amended his opinion and acknowledged that a referral did take place. However, he felt that the Respondent had still failed to meet the applicable standard of care because he failed to take adequate steps to ensure that the Patient's basal cell carcinoma was treated. This issue is addressed in the conclusions of law below.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Osteopathic Medical Examiners enter a Final Order finding the Respondent, Jules G. Minkes not guilty of the allegations contained in Count I of the Administrative Complaint and dismissing that Count, but finding Respondent guilty of Count II and III, issuing a letter of concern and imposing a fine of $500.00. DONE AND ORDERED in Tallahassee, Leon County, Florida, this 13th day of December, 1990. J. STEPHEN MENTON 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 13th day of December, 1990.
The Issue Whether Respondent, a licensed physician, violated the applicable standard of care by diagnosing prostate cancer in four patients, and recommending and participating in a course of treatment for these patients, without confirming prostate cancer through tissue biopsy results; and, if so, what is the appropriate penalty?
Findings Of Fact Petitioner is responsible for the investigation and prosecution of complaints against medical doctors licensed in the state of Florida, who are accused of violating chapters 456 and 458 of the Florida Statutes. Respondent is licensed as a medical doctor in Florida, having been issued license number ME 46625. Respondent is not board-certified in any specialty recognized by the Florida Board of Medicine. Respondent has never had disciplinary action against his license to practice medicine. Respondent's Practice Since his residency concluded in 1985, Respondent has practiced urology. For more than 20 years, the focus of his practice has been prostate disease, its diagnosis, and treatment. In 2006, Respondent became the lead investigator for a General Electric study regarding its 3-Tesla magnetic resonance spectroscopy imaging machine (3T MRI-s) as part of an Institutional Review Board measuring the heat generated by the machine to ensure the safety of patients. Between 2006 and 2010, 1,600 prostates were scanned with a 3T MRI-s as part of the study. Respondent reviewed the results of each radiology report associated with these scans and compared them to the clinical data he had for each patient. Respondent also completed a double-blind study of 200 of these patients who had prostate biopsies during 2008 and 2009, as well as the 3T MRI-s, correlated the results of the biopsies and the scans, and became convinced that the 3T MRI-s technology alone is a positive predictor of prostate cancer 95 percent of the time. According to both parties' experts, as well as Respondent, the standard of care in Florida and throughout the United States is to use a needle tissue biopsy to identify prostate cancer. As admitted by Respondent, medical schools teach that needle biopsy is "the way" to diagnose prostate cancer. Absent a biopsy showing malignant tissue, it is not possible for a reasonably prudent physician to diagnose or treat prostate cancer. Biopsies are usually performed to diagnose prostate cancer if a man has a combination of risk factors, such as family history, an abnormal digital rectal exam, and/or increasing levels of Prostate Specific Antigen (PSA). However, needle biopsies for prostate cancer carry a false negative rate of 20 to 50 percent, which means that a standard 12-point needle biopsy (where 12 samples of tissue from different locations in the prostate are sampled) often misses cancerous tissue. Prostate needle biopsies are sometimes painful and carry a risk of complications, including common complications such as bleeding and infection, and the unlikely complications of septic shock and death. Respondent is convinced that there is a significant risk from a prostate needle biopsy to spread prostate cancer cells outside the prostate capsule, which is referred to as "seeding" or "needle tracking." Respondent's belief is founded upon a one-page 2002 article published in the American Urological Association, Inc.'s Journal of Urology (Journal), which refers to two cases in which a tumor was discovered in the rectal wall after prostate biopsies and cryoblation.1/ The tumors were suspected of being the result of needle tracking from prostate cancer biopsies. Significantly, this article makes clear that needle tracking resulting from prostate biopsies are rare and "exceedingly uncommon." Respondent's concern, regarding prostate biopsies spreading prostate cancer, is also in part founded upon a one-paragraph 1991 Journal abstract reporting a Johns Hopkins University School of Medicine study of 350 patients in which needle tracking was suspected in seven patients (two percent).2/ According to Respondent, his belief that prostate biopsies spread prostate cancer is "intuitive," although he acknowledges this is not the prevailing view in Florida. Respondent argues that doctors do not want to believe needle tracking takes place with prostate biopsies and suggests there is a financial motivation for doctors to require a positive biopsy before definitively diagnosing prostate cancer. Respondent is so convinced of the dangers of needle biopsies for prostate cancer that he published a book, Men at Risk: the Dirty Little Secret – Prostate Biopsies Really Do Spread Prostate Cancer Cells, in 2012, which he provides to all his patients. In his book, Respondent states: For me, a 3T MRI scan is the best objective marker to a diagnosis of prostate cancer. To summarize, patients must answer one question. Should I agree to a prostate biopsy procedure where it has been proven to spread prostate cancer cells or do I keep my fingers and toes crossed, hoping for the best? In two words, . . . "absolutely not." To me, the decision is easy – the literature validates avoiding random biopsies and supports imaging with a 3 T magnet. There is no other organ in the human body where diagnosis is dependent on sticking needles randomly and blindly into a delicate organ in an attempt to find cancer. This practice is archaic, patently barbaric, unacceptable and preferentially favored by virtually all urologists. Beyond the obvious benefit to being able to see a cancer and its pattern of invasion with the 3.0 Tesla MRI scan, there is no other exam or scan that competes in terms of diagnostic accuracy or predictability. The discerning patient will soon recognize that guessing where cancer is located, through random biopsies, is for the less informed.[3] Respondent refers to the use of 3T MRI-s as the "truth serum" of prostate cancer diagnosis. During all times material hereto, Respondent held himself out as a urologist who could diagnose and treat prostate cancer without a needle biopsy. In fact, the four patients at issue in this case found Respondent through an Internet search. Respondent defines his office, the Diagnostic Center for Disease (DCD) as, "A comprehensive prostate cancer diagnostic center in Sarasota, Florida specializing in non-invasive diagnostics (MRI/MRIS) without biopsy as an integral part of the diagnostic evaluation of prostate cancer."4/ Respondent also advertised himself as "a world expert in High Intensity Focused Ultrasound (HIFU), having diagnosed and treated more patients for prostate cancer from more countries than any other treating doctor in the world."5/ HIFU is a treatment alternative to brachytherapy (the insertion of radioactive seeds into the prostate), radiation, and prostatectomy (the surgical removal of the prostate gland) for prostate cancer and uses highly focused ultrasound waves in a small area to create intense heat, which destroys prostate cancer tissue. HIFU was not an approved treatment for prostate cancer in the United States until October 9, 2015, at which time the Food and Drug Administration (FDA) approved the use of the Sonablate machine for prostate tissue ablation. Prior to that time, Respondent referred his patients to treatment facilities in Mexico and the Caribbean where he performed HIFU treatments. The standard of care in Florida precludes treating prostate cancer with HIFU in the absence of a tissue biopsy confirming the presence of cancer. In order to be eligible for HIFU treatment, in addition to a positive diagnosis, the patient's prostate gland must be less than 40 grams. HIFU is not appropriate on patients with multiple calcifications in their prostate because they interfere with the treatment. Because a smaller prostate gland is easier to work with, prior to undergoing HIFU treatment, patients are often prescribed Bicalutamide (also known by its brand name, Casodex) and Trelstar. Bicalutamide suppresses the uptake of testosterone and Trelstar suppresses the production of testosterone, with both drugs having the effect of shrinking the prostate gland. Side effects of these drugs include hot flashes, weakness, and a sense of a loss of well-being. Facts Related to Patient G.P. Patient G.P., a 69 year-old retiree, had a prostate biopsy performed in December 2005 after a rise in his PSA level. This biopsy was negative for prostate cancer, but Patient G.P. was diagnosed with an enlarged prostate and benign prostate hyperplasty (BPH). In May 2008, Patient G.P. learned through a physical exam for a life insurance policy that his PSA level was elevated. After another check of his PSA level in November 2008, Patient G.P. was advised to undergo another prostate biopsy. Because his first prostate biopsy was painful, Patient G.P. searched the Internet for alternatives to biopsy and learned of Respondent and his use of the 3T MRI-s at the DCD in Sarasota for diagnosing prostate cancer. Patient G.P. traveled to Florida from Michigan to meet with Respondent on January 5, 2009. Patient G.P. underwent a 3T MRI-s scan at Respondent's office. Respondent told Patient G.P. that he was unsure of the results because they were consistent with BPH and not prostate cancer. However, Respondent advised Patient G.P. was considered "high risk" because his father died from prostate cancer in 2002. Rather than undergoing any treatment at that time, Patient G.P. was prescribed Avodart for his BPH and agreed to active surveillance (A.S.) whereby he would receive regular PSA screening. When Patient G.P.'s December 2009 PSA level went up after being on Avodart for most of the year, he was concerned and telephoned Respondent's office. Respondent prescribed Casodex based upon his telephone call with Patient G.P. on January 15, 2010. By February 2010, G.P.'s PSA level decreased significantly, but not as much as he believed it should have after taking Casodex for several weeks. Patient G.P. also experienced urinary frequency problems and pain. He returned to Respondent's office where Respondent performed an ultrasound and digital rectal exam. Respondent told Patient G.P. it was likely he had prostate cancer, but that he could not be sure without a biopsy. However, Respondent's medical records reflect that Respondent diagnosed Patient G.P. as having prostate cancer without a tissue biopsy.6/ Respondent offered to do a targeted biopsy based on an MRI scan. Respondent also discussed his concerns regarding needle tracking from biopsies with Patient G.P. Patient G.P. made it clear he did not want a biopsy, and he wanted to proceed to HIFU. Respondent advised Patient G.P. of the risk of erectile dysfunction following HIFU, but did not discuss the possibility of urinary stricture problems. In April 2010, Patient G.P. traveled to Mexico where the HIFU procedure was performed by Respondent. In March 2011, Patient G.P. saw a urologist in Michigan about his diminished urinary stream and pain. The urologist used a reamer to open Patient G.P's urethra, but on April 15, 2011, he went to the emergency room because he was completely unable to urinate. Patient G.P. was catheterized and subsequently underwent electro-vaporization on April 25, 2011, to relieve the urinary stricture. In August 2011, Patient G.P. also underwent hydro- dilating in an attempt to relieve the symptoms of his urinary stricture. In September 2011, Patient G.P. saw board-certified urologist Dr. Joel Gelman, who specializes in urethral reconstruction. At that time, Patient G.P. was advised that his urinary stricture, caused by the HIFU treatment, was a significant problem because his urethra was closed off almost to the bladder neck. Dr. Gelman performed a transurethral resection of the prostate (TURP). As part of the TURP procedure, Dr. Gelman took samples of Patient G.P.'s prostate tissue and no evidence was found of prostate cancer. Although Patient G.P. had no complaints regarding his course of treatment from Respondent, Dr. Gelman filed a complaint against Respondent because he was concerned that Respondent prescribed medications and performed HIFU on Patient G.P. for prostate cancer without a tissue biopsy. Facts Related to Patient J.W. Patient J.W., a 74 year-old retired dentist, had two biopsies performed in 2005 and 2007 ordered by his urologist in Alabama in response to elevated PSA levels. No evidence of malignancy was found. Patient J.W.'s PSA level was again elevated when tested in March 2012. He was reluctant to have another biopsy because the first two were painful. Patient J.W. was told about Respondent by a friend, and he viewed Respondent's website. Patient J.W. was interested in consulting with Respondent because Respondent advertised he had an MRI machine that could detect cancer cells, and Respondent believed prostate biopsies spread cancer. Patient J.W. traveled from Alabama to meet with Respondent at the DCD on May 14 and 15, 2012. After a sonogram and MRI, Respondent diagnosed Patient J.W. with prostate cancer. Respondent discussed a treatment plan which included what Respondent called "chemical castration" for a period of six months, to be followed with a trip to Mexico for HIFU treatment at the cost of $32,000.00. Respondent did not suggest any other treatment options to Patient J.W. or recommend a tissue biopsy. The idea of "chemical castration" scared Patient J.W., who sought a second opinion in June 2012 from another urologist, Dr. M. Eric Brewer. Dr. Brewer told J.W. that HIFU was not an accepted treatment in the United States for prostate cancer. Patient J.W. declined to go forward with treatment by Respondent. Dr. Brewer recommended A.S. and, as recommended by Dr. Brewer, Patient J.W. has his PSA level checked every six months. Patient J.W.'s PSA levels have decreased without any treatment. Dr. Brewer discussed Patient J.W.'s case with his partners, the tumor board, the president of the Southeastern Urological Association, and the president of the American Board of Urology, who unanimously advised Dr. Brewer to file a complaint with Petitioner against Respondent for cancer diagnosis and recommending treatment in the absence of a pathologic specimen. Facts Related to Patient K.S. Patient K.S. is a 62-year-old video producer and editor from Tennessee. He has no family history of prostate cancer. Patient K.S. had his PSA level tested in 2005 and 2009, at which time it was considered elevated. Patient K.S. was referred to a urologist by his primary care physician. After again showing elevated PSA levels, Patient K.S. underwent a prostate biopsy in 2011 and 2012. Neither biopsy was positive for prostate cancer. However, Patient K.S. and his wife were concerned about his rising PSA level and sought a second opinion. Patient K.S.' wife was concerned that if her husband had prostate cancer, his local urologist would recommend removal of the prostate. She researched alternative treatments on the Internet and found Respondent's website. On October 15, 2012, Patient K.S. and his wife traveled to the DCD in Sarasota to meet with Respondent. Respondent initially performed an ultrasound on Patient K.S. and then told Patient K.S. he was "concerned" Patient K.S. had prostate cancer. He recommended HIFU treatment to Patient K.S. Respondent made it clear to Patient K.S. that Respondent would not perform a needle biopsy because it pushes cancer further into the prostate. Respondent told Patient K.S. that the MRI would make it clear whether Patient K.S. had prostate cancer. Later that same day, Patient K.S. had an MRI performed at the DCD. Approximately a week later, Patient K.S. received a telephone call from Respondent with the MRI results who told Patient K.S. that based on the MRI, he had Gleason 7 prostate cancer, a fairly aggressive form of prostate cancer that could be treated with HIFU in Mexico the following month. This was followed up with an e-mail from the DCD to Patient K.S. demanding a payment of $32,000.00 within three days to schedule the HIFU procedure in Mexico. Patient K.S.' wife immediately secured a bank loan for the $32,000.00 Due to the seriousness of the diagnosis and the rush for payment for HIFU, Patient K.S. visited his primary care doctor for another opinion. Patient K.S' primary care doctor, Dr. Jeffrey Jump, told him that no one can diagnose prostate cancer as a Gleason 7 without a tissue biopsy. Further, it was a "red flag" to Dr. Jump that a cash payment of $32,000.00 was expected in such a short time frame to schedule treatment. After speaking to Dr. Jump, Patient K.S. decided not to have HIFU and instead opted for A.S. Subsequent PSA level tests for Patient K.S. have shown a decrease in his PSA level. Patient K.S.' wife filed a complaint with the Petitioner against Respondent. Facts Related to Patient V.P. Patient V.P. is a 63-year-old construction worker and guide from Alaska. He has no family history of prostate cancer. In August 2013, at age 60, Patient V.P. had his first physical examination. As part of the exam, he took a PSA test, which showed an elevated PSA level of 6.3. As a result, Patient V.P. was referred to a urologist who recommended a biopsy. Patient V.P. heard from friends that prostate biopsies are painful, so he looked on the Internet for alternatives. Patient V.P. found Respondent's website, which claimed Respondent could diagnose prostate cancer without a biopsy by using new MRI technology. Patient V.P. traveled to Sarasota to meet Respondent on September 11, 2013. Respondent performed a digital rectal exam and told Patient V.P. that his prostate was much enlarged. Respondent next performed a prostate ultrasound on Patient V.P. Immediately after the ultrasound, Respondent told Patient V.P., "I'm telling you right now you have prostate cancer." Respondent provided Patient V.P. with a prescription for Bicalutamide and Trelstar, which Respondent said would wipe out Patient V.P.'s testosterone and slow the growth of the cancer. Respondent told Patient V.P. that prostate biopsies are dangerous and metastasize cancer cells. Respondent said that even though he knew Patient V.P. had cancer, he wanted an MRI to see the amount of cancer. Respondent also offered Patient V.P. the opportunity to participate in a private placement offering for a HIFU company he was forming for a minimum investment of $50,000.00. The following day, Patient V.P. had an MRI and then met with Respondent to review the results. Respondent showed Patient V.P. his MRI images and pointed to areas of concern. Respondent told Patient V.P. he had extensive prostate cancer and that Patient V.P. did not have much time to decide whether to have HIFU because the cancer was about to metastasize. Respondent told Patient V.P. to take the Bicalutamide for ten days and then return for an injection of Trelstar to atrophy his prostate and make him ready for HIFU in 90 days. At Respondent's direction, Patient V.P. began the Bicalutamide and then returned to the DCD on September 20, 2013, for a three-month injection of Trelstar. During this visit, Patient V.P. questioned the cost if the HIFU was not successful in getting all the cancer and he needed further treatment. Respondent told Patient V.P. that he "doesn't miss," but an additional treatment of HIFU would cost another $10,000.00 to $12,000.00, in addition to the $32,000.00 for the initial treatment. Concerned about these costs, Patient V.P. asked about going to Loma Linda, California, for proton therapy as an alternative. Respondent told Patient V.P. that proton therapy would cause bladder cancer and any alternative to HIFU would require a needle biopsy first. Respondent actively discouraged Patient V.P. from any non-HIFU treatment for prostate cancer. As soon as Patient V.P. questioned Respondent about alternatives to HIFU, he was suddenly fast-tracked for HIFU scheduled October 24 through 26, 2013. He was told he needed to make a $10,000.00 deposit to hold the date and the total cost was $32,000.00. Despite his concerns regarding the expedited scheduling of his procedure and the cost of the HIFU treatment, Patient V.P. returned to the office with a check for $10,000.00 to cover the cost of the deposit to hold the October treatment date. While waiting to hand the check to Respondent's receptionist, Patient V.P. overheard Respondent on a speakerphone arguing with a radiologist concerning an MRI report. Respondent was insisting the radiologist include the word "cancer" on MRI reports and the radiologist insisted it was not possible for him to make such a diagnosis. After hearing this conversation, Patient V.P. immediately left Respondent's office with his check. Patient V.P. subsequently discussed his experience with a trusted friend who practiced as a nurse in a cancer clinic. She, too, expressed concerns about diagnosing and treating prostate cancer without a biopsy. Patient V.P. was referred by this friend to Dr. Vipul Patel, a physician specializing in urologic cancer in Orlando. Patient V.P. met with Dr. Patel on October 18, 2013. Dr. Patel advised Patient V.P. that it was not possible to diagnose prostate cancer without a biopsy. Dr. Patel also disputed that prostate biopsies can spread prostate cancer. Dr. Patel performed a digital rectal exam and found Patient V.P.'s prostate to be slightly enlarged (which is not abnormal for a man of Patient V.P.'s age), normal, and smooth. Dr. Patel told Patient V.P. that he doubted he had prostate cancer. Patient V.P. then underwent a prostate biopsy by Dr. Patel, which was negative for prostate cancer. This was surprising to Patient V.P. because Respondent led him to believe, based on the MRI, that his prostate was full of cancer. Patient V.P. experienced significant side effects as a result of taking the medications ordered by Respondent. The Bicalutamide caused Patient V.P. to experience overwhelming depression, shakes, hot flashes, tunnel vision, and headaches. The Trelstar caused erectile dysfunction, increased frequency of hot flashes, night sweats, and made Patient V.P. so weak he was unable to work for eight months. Standard of Care As discussed above, the experts who provided depositions or live testimony in this case were unanimous in their conclusions that the standard of care in Florida from 2008 through 2013 precluded diagnosis or treatment of prostate cancer in the absence of a tissue biopsy. A reasonably prudent physician would not tell a patient he had prostate cancer based upon an ultrasound and/or MRI. A reasonably prudent physician would not prescribe medication, suggest treatment, or participate in treating a patient for prostate cancer, based upon an ultrasound or MRI. Respondent claims that in each of these cases, he advised the patient that a needle biopsy was the definitive test for prostate cancer, but it was a method he did not favor due to the possibility of needle tracking. Respondent's testimony in this regard is not credible in light of the credible testimony of the three patients that Respondent made clear he would not perform a needle biopsy and actively discouraged them from anything other than diagnosis by MRI and subsequent HIFU treatment. Respondent's suggestion, that he offered needle biopsy as an option, is wholly inconsistent with the title, theme, and contents of his own book, and the manner in which he defined his method of diagnosing prostate cancer at the DCD in his book and on his website. It is self-evident that a patient's perceptions regarding the safety and efficacy of needle biopsies for prostate cancer detection are at least, in part, influenced by the discussion with the physician. Respondent's active efforts to dissuade these patients from having the one definitive test for prostate cancer, by dramatically over-inflating the infinitesimally small possibility of needle tracking, were wholly inconsistent with the standard of care. Respondent claims that these four patients insisted they did not want a needle biopsy, therefore, it was appropriate to diagnose them on the basis of "a preponderance of the evidence and concordance of data" and move forward with a treatment plan, including medications and HIFU. The standard of care in Florida during 2008 through 2013, for a situation in which a patient suspected of having prostate cancer refused a needle biopsy, was to prescribe a course of A.S., including regular and frequent PSA testing, and to offer no other treatment.7/ Ultimate Factual Determinations Petitioner established by clear and convincing evidence that Respondent committed medical malpractice in his treatment of Patients G.P., J.W., K.S., and V.P. by the following violations of the standard of care: failing to obtain and review prostate biopsy results before confirming the patient had, or diagnosing the patient with, prostate cancer (Patients G.P., J.W., K.S., and V.P.); prescribing Bicalutamide/Casodex to a patient without first confirming through a prostate tissue biopsy that the patient has prostate cancer (Patients G.P. and V.P); prescribing, injecting, or authorizing the injection of Trelstar to a patient without first confirming through biopsy results that the patient has prostate cancer (Patient V.P); recommending and/or attempting to facilitate HIFU treatment without first confirming through biopsy results that the patient has prostate cancer (Patients G.P., J.W., K.S., and V.P.); and participating in, and/or assisting with the performance of HIFU treatment for a patient without first confirming through biopsy results that the patient has prostate cancer (Patient G.P.). Accordingly, Respondent is guilty of the offense defined in section 458.331(1)(t), Florida Statutes.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding that Respondent violated section 458.331(1)(t), Florida Statutes, as charged in Amended Administrative Complaints; imposing a fine of $30,000.00; revoking Respondent's medical license; and imposing costs of the investigation and prosecution of this case. DONE AND ENTERED this 24th day of February, 2017, in Tallahassee, Leon County, Florida. S MARY LI CREASY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 24th day of February, 2017.
The Issue The issues in this case are whether Respondent violated Subsection 458.331(1)(t), Florida Statutes (2004),2 and, if so, what discipline should be imposed.
Findings Of Fact The Department is the state agency charged with the regulation of the practice of medicine pursuant to Chapters 20, 456, and 458, Florida Statutes. Dr. Roush is a licensed medical doctor in the State of Florida, having been issued license No. ME 83992. He is board- certified in general surgery by the American Board of Surgery. On February 8, 2005, V.R. presented to the emergency department at Winter Haven Hospital, Inc. Her chief complaint was “near syncope,” which means near fainting. She had fallen and hit her left ribs. She denied hitting her head and stated that she never “went completely out.” She complained of feeling dizzy when she stood. While in the emergency department, V.R. had a CT which indicated an abnormality. She was admitted to the hospital by Ernesto J. Perez, M.D., who was the attending physician. V.R.’s medical history included hypertension, osteoarthritis, osteoporosis, and gastroesophageal reflux disease. A brain magnetic resonance imaging (MRI) and a carotid magnetic resonance angiography (MRA) were ordered for V.R. After the MRI and MRA were completed, V.R. was seen by Juan L. Joy, M.D., who reviewed the test results. Dr. Joy found that both studies were “unremarkable.” Specifically, Dr. Joy found that the MRI showed no posterior fossa lesions. The radiographic report of the MRA showed that there was “approximately 70 to 80 percent luminal narrowing of the proximal left ICA." Because of the abnormal MRA, Dr. Perez consulted with Dr. Roush. Dr. Roush examined the patient and felt that V.R.’s symptoms were consistent with inner ear cochlear malfunction. However, he determined that V.R. had left-sided 70 to 80 percent carotid stenosis. His assessment of V.R. was that she was “a 66-year-old female with probable asymptomatic high-grade stenosis in the left carotid internal artery." He recommended a carotid endarterectomy, which is a procedure that removes plaque from the lining of the carotid artery. An MRA is used to diagnose blockages or stenosis in the carotid arteries. An MRA can overestimate the degree of blockage. Other studies such as ultrasound, carotid Doppler studies, and standard arteriography are used to diagnose carotid stenosis. Roush did not order or perform any additional diagnostic studies to confirm the results of V.R.’s MRA prior to making the surgical recommendation. Dr. Roush performed the carotid endarterectomy on V.R., but no carotid stenosis was found. An ultrasound of the right carotid artery was ordered to determine if the original MRA had been of the right carotid rather then the left. The ultrasound showed that there was “no hemodynamically significant stenosis” and “no plaque” in the right carotid. The Department presented Dr. Michael J. Cohen as its expert witness. Dr. Cohen is board-certified in vascular surgery. It was Dr. Cohen’s opinion that an MRA, alone, was not sufficient to diagnose carotid stenosis and that Dr. Roush fell below the standard of care by not ordering additional diagnostic tests prior to recommending surgical intervention. Dr. Cohen's opinion is credited. The MRA showed a blockage of 70 to 80 percent. Dr. Cohen credibly opined that most vascular surgeons would not have operated on an asymptomatic patient such as V.R. with that level of stenosis without additional testing. It was Dr. Cohen’s credible opinion that the carotid endarterectomy which Dr. Roush performed on V.R. was an unnecessary surgical procedure; thus, Dr. Roush fell below the standard of care when he performed the surgery.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Dr. Roush violated Subsection 458.331(1)(t), Florida Statutes; imposing an administrative fine of $10,000; requiring 25 hours of community service; requiring Dr. Roush to take no less than five hours of Risk Management Continuing Medical Education coursework; and issuing a reprimand. DONE AND ORDERED this 16th day of November, 2007, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 16th day of November, 2007.
The Issue The issue in this case is whether the Board of Medicine (Board) should revoke or otherwise discipline the Respondent’s medical license for violating section 458.331(1)(t) and (u), Florida Statutes (2011), by using experimental stem cell therapy that did not meet the standard of care and by not getting the patient’s informed consent.
Findings Of Fact The Respondent is licensed to practice medicine in Florida. He holds license ME 45186. He is a board-certified anesthesiologist. In mid-2011, the Respondent began working at Jouvence Medical in Sarasota and was offered the opportunity to take over the stem cell medicine practice of Dr. Feinerman, who was treating patients with lung disease using an intravenous autologous stem cell procedure. The Respondent had no formal training in stem cell medicine, which is not normally practiced by anesthesiologists, but the Respondent observed Dr. Feinerman perform his stem cell procedure and correctly concluded that he was fully capable of performing it himself. In addition, the Respondent had strong interest in stem cell medicine and gained some knowledge of it from studying literature while seeking stem cell therapy for his elderly father, who has chronic obstructive pulmonary disease. On September 14, 2011, patient J.F. presented to the Respondent at Jouvence with a number of medical issues, including post-polio syndrome and end-stage idiopathic pulmonary fibrosis (IPF). The standard of care for end-stage IPF is supportive management, including oxygen, which was offered and being provided by the patient’s primary physician and pulmonologist, who referred the patient to Jouvence for a stem cell treatment that might provide additional health benefits and possibly extend the patient’s life, or even cure him. On seeing the patient on September 14, 2011, the Respondent appropriately took his history, reviewed his medical records and various test results, and offered the autologous stem cell procedure he learned from Dr. Feinerman. The Respondent adequately explained to the patient how the procedure would be performed and how much it would cost. He told the patient that results were not guaranteed, but that some patients reported receiving benefits from the treatment. The patient signed a consent form acknowledging and documenting what the Respondent told him. It certainly was true that the procedure’s hoped-for results were not guaranteed, but just saying that was inadequate to inform the patient. The procedure proposed by the Respondent essentially consisted of: a 60 cubic centimeter (cc) blood draw, and intravenous infusion of 150 micrograms (mcg) of Neupogen; concentration of the drawn blood in a centrifuge; and, the next day, peripheral intravenous infusion of 10 cc’s of the patient’s concentrated blood, together with 100 cc’s of saline solution. According to the Respondent, the treatment would confer maximum benefits by delivering mesenchymal stem cells directly into the patient’s fibrotic lungs and also by stimulating the patient’s bone marrow to produce additional mesenchymal stem cells that would migrate to and concentrate in the lungs. Once in the lungs, the mesenchymal stem cells theoretically would differentiate and regenerate healthy, non-fibrotic lung tissue to replace fibrotic tissue. Mesenchymal stem cell treatments to regenerate heart tissue have been successful, and it is hoped that these treatments increasingly will replace heart transplants and surgeries. The similar use of mesenchymal stem cells for lung disease is being studied in vigorously regulated and controlled FDA-approved trials, which are experiments on human subjects. Safety trials were held in 2015 and 2016. So far, the trials have not progressed beyond safety trials; trials to determine efficacy have not begun. The FDA-approved trials of stem cell treatments for lung disease are much different from the procedure performed by the Respondent. They involve the extraction, concentration, and characterization of tens or hundreds of millions of mesenchymal stem cells from human donors and the use of those stem cells to treat human subjects. The Respondent’s treatment was so different from these trials that it did not even require FDA approval. It was unrealistic for the Respondent to think it likely that the procedure he performed on J.F. would result in regeneration of lung tissue. Blood contains a minimal number of mesenchymal stem cells. Neupogen is a granulocyte colony- stimulating factor that is administered (usually in multiple doses over a relatively long period of time, especially when administered through the peripheral veins, as done in the Respondent’s procedure) to chemotherapy patients to amplify the development of white blood cells called neutrophils. Neutrophils are hematopoietic stem cells, which do not differentiate as mesenchymal stem cells do. The two injections of Neupogen administered in the Respondent’s procedure would not be expected to increase the production of mesenchymal stem cells significantly. There was no reasonable expectation that the procedure performed by the Respondent would introduce a significant amount of mesenchymal stem cells into the patient’s lungs so as to achieve the maximum hoped-for benefit of regenerating lung tissue. There had been anecdotal reports that patients have benefited from the treatment offered to J.F. by the Respondent. Since the functioning of stem cells in the body was not well known at the time, it was possible that some of the reported benefits are real. It is possible that the introduction of even a small number of stem cells, either mesenchymal or hematopoetic, could reduce inflammation in the lungs and stimulate the production of additional stem cells in the bone marrow. (There also could have been benefits from a placebo effect, even if not intended by the Respondent.) The procedure performed by the Respondent was fairly benign. Since the patient’s own blood was being used, there was little or no risk of rejection. There is a risk of infection from any blood draw and infusion. While the risk of infection was relatively small, the harm to a patient in J.F.’s condition from any infection would be significant and could result in the loss of lung tissue. Loss of consciousness was another risk from the procedure that was small but serious for a patient in J.F.’s condition. There also was some risk of pulmonary emboli, albeit small. The patient survived the procedure performed on September 14 and 15, 2011. The evidence was not clear, but it suggested that the patient was neither harmed nor benefited. About a month later, the patient’s condition worsened and he died, which was not unexpected given his dire medical condition. After J.F. died, his life partner R.C. asked the Respondent to return the $5,000 he had paid for J.F.’s procedure. The Respondent referred him to Jouvence, which declined to return the money. R.C. filed a complaint with the Department of Health, which investigated and filed the pending Administrative Complaint. Shortly after J.F. died, the Respondent decided to discontinue offering the procedure to similar patients because the small chance of benefits did not outweigh the risk of infection. As to the charge that the Respondent practiced below the standard of care, the standard of care for the patient J.F. was supportive management, which the patient’s other doctors already were providing. The Respondent offered the patient the possibility of a health benefit beyond the standard of care. Although the chances of complete success were extremely small to nonexistent, there was a chance of some health benefits, and the concomitant risks were not clearly unreasonable. The procedure was performed in an appropriate manner in all other respects. As to the charge of experimentation without giving informed consent, the Respondent should have been more forthright in disclosing to the patient that his chances of receiving a medical benefit were very small and that the chances of a cure or an appreciable lengthening of his life were extremely small. It was not enough to say “results are not guaranteed.”
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 the Respondent guilty of a violation of section 458.331(1)(u); placing him on probation for one year; and fining him $1,000. DONE AND ENTERED this 20th day of December, 2016, in Tallahassee, Leon County, Florida. S J. LAWRENCE JOHNSTON 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 20th day of December, 2016. COPIES FURNISHED: Chad Wayne Dunn, Esquire Department of Health Prosecution Services Unit Bin C-65 4052 Bald Cypress Way Tallahassee, Florida 32399 (eServed) Augustine Smythe Weekley, Esquire Weekley Schulte Valdes, LLC Suite 100 1635 North Tampa Street Tampa, Florida 33602 (eServed) Sarah E. Corrigan, Esquire Department of Health Prosecution Services Unit, Bin C-65 4052 Bald Cypress Way Tallahassee, Florida 23299 (eServed) Claudia Kemp, JD, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin C-03 Tallahassee, Florida 32399-3253 (eServed) Nichole C. Geary, General Counsel Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 (eServed)
The Issue Whether Respondent committed the offenses described in the Administrative Complaint? If so, what disciplinary action should be taken against him?
Findings Of Fact Based upon the record evidence, the following Findings of Fact are made: Respondent is now, and has been since October 18, 1977, a physician authorized to practice medicine in the State of Florida under license number ME 0013979. He is a board certified dermatologist and dermapathologist. Respondent's practice is located in St. Lucie County. He is the only dermapatholgist in the county. E.M. is a former patient of Respondent. He is a fair complected retiree with red hair who has lived his entire life in areas that have warm and sunny climates. Fair complected individuals are more prone to develop skin cancers as a result of exposure to the sun than are their darker complected counterparts. E.M. had been treated for skin cancer on several occasions, dating back to some time between 1954 and 1960, before becoming Respondent's patient. In June of 1988, E.M. became concerned about two lesions that he had in a dime-sized area on his left forearm below the elbow. The lesions were scaly and crusted in texture, pea-sized in diameter, irregularly shaped, reddish in color and sensitive to the touch. E.M.'s concern led him to make an appointment to see Respondent. His initial visit to Respondent's office was on June 29, 1988. Because he was a new patient, E.M. filled out a medical history form before going into the examining room. Respondent did not give E.M. a complete physical examination. He examined only E.M.'s left forearm. His examination revealed the lesions about which E.M. was concerned. These were not the only lesions Respondent discovered on E.M.'s left forearm, however. By all appearances, the lesions on E.M.'s left forearm were pre- cancerous growths. There was no evidence of any ulceration, discharge, bleeding or other indication that these lesions were malignant. Having no reason to suspect that these lesions were cancerous, Respondent determined that they were solar keratoses, which are pre-malignant growths that appear on the superficial layers of sun damaged skin. E.M. had told Respondent before the examination that he had previously used Efudex, which is a chemotherapeutic drug used in the treatment of solar keratoses. Accordingly, at the time he made his diagnosis, Respondent knew that E.M. had a history of pre-cancerous growths. As a general rule, Respondent treats growths of the type he found on E.M.'s left forearm with cryosurgery1 and cauterization.2 If, after two or three such treatments, sufficient progress has not been made, he will then perform a biopsy to determine if there are cancerous cells in the deeper layers of the skin. In accordance with his usual practice, Respondent, during E.M.'s first visit on June 29, 1988, treated the lesions on E.M.'s left forearm, which Respondent reasonably believed to be pre-cancerous growths, with cryosurgery and cauterization. He then gave E.M. a cortisone cream to apply to the treated areas to aid the healing process. An appointment for a follow-up visit was made for July 13, 1988. Respondent next saw E.M. on July 13, 1988. His examination of E.M.'s left forearm on July 13, 1988, did not reveal any evidence of a malignancy, however, he did determine that there was a need to, and therefore he did, perform additional cryosurgery. Respondent sent E.M. home with a cream that contained not only cortisone to aid in healing, but an antibiotic as well to prevent against infection. An appointment for a second follow-up visit was made for July 27, 1988. E.M.'s next visit to Respondent was on July 27, 1988. Respondent's examination of E.M.'s left forearm on July 27, 1988, revealed that the treated areas were slowly healing. Based upon his examination, he had no reason to suspect a malignancy. Nor was there any indication that further cryosurgery was necessary. Respondent noted a flat, pigmented lesion in close proximity to the areas on E.M.'s left forearm that had been treated during his two previous visits. Respondent was not particularly concerned about this lesion,3 but he nonetheless mentioned to E.M. that it might be a good idea to have it biopsied to be on the safe side. E.M. responded that he preferred that such a biopsy not be performed. Respondent did not pursue the matter any further during the visit. Once again, Respondent gave E.M. a different cream to apply to the areas that had been treated. This time it was a pure antibiotic ointment. An appointment for a third follow-up visit was made for the morning of Wednesday, August 10, 1988. Respondent typically schedules biopsies and excisions on Wednesday mornings. E.M. cancelled his August 10, 1988, appointment with Respondent. He did not make another appointment. Accordingly, Respondent did not see E.M. as a patient again. In failing to biopsy the lesions on E.M.'s left forearm, which he had no reason to suspect were cancerous, Respondent did not act in a manner that was inconsistent with what a reasonably prudent physician with his training and experience would have done under like circumstances. More than a year later, in September, 1989, E.M. noticed that a lesion on his left forearm had opened and was draining. E.M. went to see Dr. Gary Marder, an osteopathic physician who specializes in dermatology. Marder suspected a malignancy. Accordingly, he performed a biopsy and scheduled E.M. for surgery. The initial biopsy report indicated an "invasive moderately differentiated squamous cell carcinoma." After Marder surgically excised the area, the pathologist revisited the matter and changed his diagnosis to an amelanotic melanoma, which is a rare type of melanoma4 that is characterized by an absence of pigmented cells. Pigmented lesions, like the one Respondent noticed on E.M.'s left forearm during E.M.'s July 27, 1988, visit, are not precursors of amelonotic melanomas. It was subsequently determined that the cancer had spread. Cancerous lymph nodes were removed from E.M.'s axilla in April, 1990, and from his elbow in November, 1990.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that the Board of Medicine enter a final order dismissing the instant Administrative Complaint against Respondent in its entirety. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 23rd day of January, 1992. STUART M. LERNER 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 23rd day of January, 1992. 1/ Respondent uses liquid nitrogen to freeze and destroy the unwanted tissue. 2/ The cautery device that Respondent uses is battery-operated and produces a low current. It is particularly effective in removing rough, hard-crusted areas of skin. 3/ It did not even appear to be a pre-cancerous condition. 4/ Melanomas are one of the three types of skin cancers. Basal cell carcinomas and squamous cell carcinomas, which together account for 98% of all cancers, are the two other types. Of these three types of cancers, melanomas are the most destructive and the most likely to metastasize. 5/ Respondent has not been charged with failing to keep adequate medical records. 6/ Precisely what information E.M. provided on this form is unclear. 7/ The issue is not whether the practice described in this proposed finding is common, but whether it is acceptable. 8/ As noted above, the adequacy of Respondent's medical records are not at issue in the instant case. 9/ The Department did not advance this theory in the Administrative Complaint. APPENDIX TO RECOMMENDED ORDER IN CASE NO. 91-3696 The following are the Hearing Officer's specific rulings on the findings of fact proposed by the Department: Accepted and incorporated in substance, although not necessarily repeated verbatim, in this Recommended Order First sentence: Accepted and incorporated in substance; Second and fourth sentences: Rejected because they are more in the nature of summaries of testimony than findings of fact; Third sentence: To the extent that this proposed finding suggests that there was also a "pigmented lesion" on E.M.'s left forearm that Respondent observed during E.M.'s first visit to his office, it has been rejected because it is not supported by persuasive competent substantial evidence. Rejected because it would add only unnecessary detail to the factual findings made by the Hearing Officer.5 First sentence: Accepted and incorporated in substance;6 Second sentence: Rejected because, even if true, it would have no bearing on the outcome of the instant case. Rejected because, even if true, it would have no bearing on the outcome of the instant case. First sentence: Accepted and incorporated in substance; Second sentence: Rejected because it would add only unnecessary detail to the factual findings made by the Hearing Officer. Rejected because, even if true, it would have no bearing on the outcome of the instant case. Rejected because it would add only unnecessary detail to the factual findings made by the Hearing Officer. Rejected because, even if true, it would have no bearing on the outcome of the instant case. First sentence: Accepted and incorporated in substance; Second sentence, fragment before comma: Accepted and incorporated in substance; Second sentence, fragment after comma: Rejected because, even if true, it would have no bearing on the outcome of the instant case. 11-12. Accepted and incorporated in substance. 13. Rejected because, even if true, it would have no bearing on the outcome of the instant case. 14-17. Accepted and incorporated in substance. Rejected because, even if true, it would have no bearing on the outcome of the instant case.7 First sentence: Rejected because it would add only unnecessary detail to the factual findings made by the Hearing Officer; Second sentence: Accepted and incorporated in substance. First sentence: Accepted and incorporated in substance; Second sentence: Rejected because it is more in the nature of a summary of testimony than a finding of fact; Third sentence: To the extent that this proposed finding suggests that Respondent believed that the pigmented lesion was a squamous cell carcinoma, it is rejected because it is not supported by persuasive competent substantial evidence. First sentence: Rejected because it is more in the nature of a summary of testimony than a finding of fact; Second sentence: Accepted and incorporated in substance; Third sentence: Rejected because it constitutes argument regarding the credibility of testimony rather than a finding of fact. Rejected because it would add only unnecessary detail to the factual findings made by the Hearing Officer.8 First sentence: Rejected because it is more in the nature of a summary of testimony than a finding of fact; Second sentence: To the extent that this proposed finding states that "E.M. had had several prior biopsies . . . [and therefore] was aware of the reasons for a biopsy," it has been accepted and incorporated in substance. To the extent that it suggests that Respondent never recommended to E.M. that a biopsy be performed on the pigmented lesion that Respondent observed on E.M.'s left forearm during the July 27, 1988, visit and that, if such a recommendation had been made, E.M. "would have willingly submitted," it has been rejected because it is contrary to the greater weight of the evidence. Rejected because, even if true, it would have no bearing on the outcome of the instant case. Accepted and incorporated in substance. First sentence: Rejected because it is not supported by persuasive competent substantial evidence; Second and third sentences: Rejected because they would add only unnecessary detail to the factual findings made by the Hearing Officer. First sentence: Rejected because it is more in the nature of a recitation of testimony than a finding of fact; Second sentence: Rejected because it would add only unnecessary detail to the factual findings made by the Hearing Officer. 28-29. Rejected because they would add only unnecessary detail to the factual findings made by the Hearing Officer. 30-34. Accepted and incorporated in substance. Rejected because it would add only unnecessary detail to the factual findings made by the Hearing Officer. Third sentence: Accepted and incorporated in subst ance; Remaining sentences: Rejected because they would add only unnecessary detail to the factual findings made by the Hearing Officer. Rejected because it would add only unnecessary detail to the factual findings made by the Hearing Officer. Rejected because, even if true, it would have no bearing on the outcome of the instant case. Rejected because it is contrary to the greater weight of the evidence. Rejected because, even if true, it would have no bearing on the outcome of the instant case.9 COPIES FURNISHED: Mary B. Radkins, Esquire Department of Professional Regulation 1940 North Monroe Street, Suite 60 Tallahassee, Florida 32399-0792 Shamsher Singh, M.D. 1701 Hillmoor Drive, #A-3 Port St. Lucie, Florida 34952 Dorothy Faircloth, Executive Director Board of Medicine Department of Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792 Jack McRay, General Counsel Department of Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792
