The Issue The issue in this case is whether the Board of Medicine should discipline Respondent, Zannos Grekos, M.D., on charges arising out of a stem cell treatment performed on a patient on March 24, 2010, and the subsequent death of the patient.
Findings Of Fact Respondent is licensed as a medical doctor in Florida, holding license ME 61912. His medical practice is in Bonita Springs, Florida. Respondent is board-certified in cardiovascular disease and board-eligible in internal medicine. Respondent also performs stem cell treatments. D.F. was born February 10, 1941. She first began to see Respondent in October 2007 for numerous medical complaints. She had peripheral neuropathy, secondary to chemotherapy for cancer, and complained of a loss of feeling in her hands and especially in her feet. She also complained of poor balance, inability to walk with an appropriate gait, and diplopia. In addition to Respondent, D.F. saw several other physicians, including a neurologist, but saw little or no improvements. In February 2010, D.F. consulted with Respondent to determine whether stem cell therapy, which he advertised, could help her. Respondent proposed an injection of stem cells from her bone marrow, through a catheter, into the arterial circulation of her brain. Respondent told the patient that the treatment possibly could improve her neurological deficits and that she would be no worse off if it did not achieve the desired results. Although D.F. had medical conditions that possibly could respond to appropriate stem cell treatment, the evidence was clear and convincing that her peripheral neuropathy would not respond to an injection of stem cells into the brain or central nervous system. D.F. signed three "informed consent" forms in early 2010. DOH attempted to prove that there were serious irregularities in some of the consent forms--namely, that patient and witness signatures were forged. DOH did not prove this charge by clear and convincing evidence. The greater weight of the evidence indicated that the signatures on the forms were authentic and valid. On February 17, 2010, the patient signed a Consent and Acknowledgement Form for PRP and/or BMAC [bone marrow aspirate concentrate] Procedure. It confirmed the patient's election to undergo "a state of the art treatment that involves using my own adult stem cells . . . with full knowledge of the possible risks and complications that may exist with the procedure." She acknowledged "that though rare, serious risks may be associated with this procedure and may include infection, stroke, heart attack, kidney failure and death." On February 20, 2010, the patient signed a Cell Therapy Product Supply Agreement with Regenocyte Worldwide, Inc., a corporation owned and controlled by Respondent and registered in Panama. This agreement informed the patient that she was paying Regenocyte for the cells to be used in her stem cell treatment, as well as Respondent's "facility fees," which would be paid to Respondent by Regenocyte. It also informed the patient that her stem cell treatment "has shown statistically significant efficacy and safety in the clinical trial sponsored by the cell producer and in patients treated outside the clinical trial." Regenocyte declined to warrant or guarantee the effect of the therapy on the patient. The agreement informed the patient that she was paying for a "product . . . made from your own cells." The agreement defines "Cell Therapy Product" as "a biological product containing Patient's own cells." The patient was cautioned that although the stem cell product would be made from her own cells, it was possible that she could have adverse effects from the procedure or the cells themselves, even though "no adverse effects from the cells have been shown in any patient treated so far with Regenocyte's cells, in or out of our clinical trial . . . ." The form had the patient acknowledge that her treatment was "innovative and novel" and that Regenocyte was making no guarantee or warranty as to its effect or that it would cure the patient. Finally, the form had the patient acknowledge her understanding "that though rare, serious risks may be associated with this procedure and may include, but certainly not limited to infection, stroke, heart attack, kidney failure and death." The agreement also had the patient alone assume all risk after careful review of her medical condition. It stated: "Although adverse effects have not been shown in clinical trial with these cells[,] adverse effects and danger exists in all surgical procedures and unknown consequences related to a new therapy, even autologous (your own cells) therapy." The form had the patient waive all liability, except for negligence or willful misconduct. The procedure was scheduled for March 24, 2010, at Respondent's facility. The patient arrived at Respondent's facility before 9 a.m., accompanied by her husband and her friend, Effie Grekos, who is Respondent's mother. There, she signed another form, this one consenting to a procedure described as "bone marrow aspirate [BMA] and delivery of cells" and an angiogram of the carotid arteries "[w]ith full knowledge of the possible risks and complications of the procedure." The form had her also agree: "My doctor has discussed with me the nature and purpose of this procedure, the risks involved, and the possibility of complications with no guarantees or assurance." Respondent was delayed and did not arrive at the facility until after noon. At approximately 1 p.m., the patient was taken to the cath lab, sedated, and anesthetized. When the procedure began, Respondent used four syringes to aspirate a total of approximately 240 cubic centimeters (cc's) of bone marrow from the iliac crest of D.F.'s hip bone. The bone marrow was aspirated through a 170 to 260 micron-sized blood filter and stored in a standard blood collection bag for later use. Respondent then inserted a catheter into a blood vessel in the patient's groin and advanced it up through her circulatory system and, ultimately, to her carotid and vertebral arteries. Via the catheter, he performed a cerebral angiogram with contrast to visualize the carotid and vertebral arteries prior to infusion of the patient's autologous BMA. The angiogram confirmed that there was no blockage, but it revealed that the patient's right vertebral artery was dominant, meaning it was larger and supplied more blood to the brain than the left vertebral artery, which was narrowed by plaque burden. For that reason, the left carotid and left vertebral arteries were not aggressively pursued and were not cannulated for injection of contrast during the angiogram. A cerebral angiogram itself is an inherently risky procedure. Even if performed flawlessly, there is a one percent chance that a stroke will ensue. This is because the vasculature in the brain and brain stem is the most delicate and dangerous vasculature in the body. The carotid artery is about seven millimeters (mm) in diameter, the vertebral arteries narrow from about three mm in the neck to about 2.0 to 2.5 mm in the brain, where they become the basilar arteries that supply blood to the cerebellum and medulla via smaller and smaller branches culminating in capillaries that are just 8 to 10 microns (thousandths of a mm) in diameter. Blood cells are about the same size, meaning they must pass through the capillaries single-file. Anything larger will clog the capillaries and result in a stroke. Due to the risks involved, great care must be taken in performing a cerebral angiogram. The contrast used is not thicker than blood and is clear so that it can be determined before injection via syringe that it does not contain any particulate matter, bubbles, blood clots, or anything that could cause a stroke. In addition, the minimum amount of contrast is used--usually not more than eight cc's. After the cerebral angiogram, Respondent proceeded to insert the patient's autologous BMA into the catheter in the patient's groin and infused it into the patient's carotid and vertebral arteries, where the BMA entered the cerebral circulation of the patient's brain. The patient's autologous BMA was not filtered again, concentrated, or processed in any manner before infusion. BMA is very different from the contrast used in a cerebral angiogram. It is thick, aggregates, and contains not only stem cells but also blood cells and other particulate matter, including fat cells and bone spicules. In the treatment attempted by Respondent, particulate matter naturally occurring in BMA, up to the diameter of the filter used in obtaining the BMA, was allowed to enter into the patient's cerebral circulation. It was not possible to determine exactly what particulate matter was in the BMA being infused. However, it is clear from the evidence that due to the size of the filter, the size of the blood vessels in the brain where the BMA was infused, and the very large amount of BMA infused in this fashion (at least 180 cc's and perhaps up to 240 cc's), it was virtually inevitable that the procedure would clog blood vessels in the brain and cause a major and very possibly fatal stroke. Respondent should have known the grave risk of the procedure he performed on the patient. Instead, he denies the gravity of the risk. He testified that he did not know what would happen as a result of the procedure. The procedure ended at 5:15 p.m. Respondent left the facility and had his CVT and medical office staff assist the patient and her husband. About half an hour later, the patient's husband joined his wife in recovery. At the time, the patient still was under the influence of her sedation and anesthesia. She was sleepy, groggy, uncommunicative, and unable to walk. The patient remained in recovery until about 6:45 p.m., when it was decided that the sedation and anesthesia had worn off enough for Respondent's staff to help the patient's husband and Effie Grekos get the patient into her husband's car to be driven home. The patient still could not walk without considerable assistance, was still somewhat sleepy and groggy, and was not speaking normally although she was able to communicate somewhat. They left the office about half an hour later. When they arrived home, it was close to 8 p.m. The patient's husband and Respondent's mother helped get the patient into the house. Once there, against the instructions of Respondent's staff, the patient's husband allowed his wife to sit up in a reclining chair, instead of confining her to bed rest. For the next hour or two, the patient remained in the chair. She was able to communicate, but still was not speaking normally. Respondent's mother left and returned to her home at approximately 9 p.m. The patient's husband went to sleep in his bedroom, leaving his wife in the reclining chair. A few hours later, the patient fell onto the floor, hit her face and mouth on the couch, and began to vomit uncontrollably. When the patient's husband found her on the floor, he tried to help her up, cleaned up the vomit, and called 911. The North Naples Fire Department arrived at the scene first, followed some time later by the EMS technicians. The EMS technicians had no present recollection of the patient and relied on their written report, which was ambiguous in some respects. It states the patient was found on the floor in the bedroom but does not clearly state who found her or how she got there. It states the patient's skin color was pale, meaning abnormal, and that she was lethargic but that she responded to verbal contact. However, a computer-generated entry on the report form states the patient was "alert." That entry was triggered by a score of 14 out of 15 on the Glasgow Coma scale, which meant she was not "unresponsive" or "lethargic" but "responded to verbal contact," although she did not speak spontaneously and did not look at anyone until they spoke to her. It reports that the patient said she got up to go to the bathroom and fell forward to the carpeted floor, striking her head on the couch. The patient was not considered to be incoherent or immobile, but her husband had to sign her name for her on the report form. The report states that the patient had a cervical injury and pain, but also states that the fall was mild in severity. The patient was taken by ambulance to North Collier Community Hospital at approximately 2 a.m. Although the patient's husband had been unable to contact Respondent by calling his office telephone, Respondent was contacted by the hospital staff and, at approximately 5:30 a.m., had the patient transferred and admitted to Naples Community Hospital. There, she was diagnosed as having had a stroke that caused debilitating and irreparable damage to the cerebellum and medulla of her brain. The patient never recovered or improved, and she died on April 4, 2010. There was conflicting testimony and evidence as to the cause of the stroke and how quickly the stroke progressed after the procedure. The patient's husband testified that his wife showed symptoms that, if factual, would have signified an immediate, massive stroke early in the evening, soon after the procedure ended. The testimony of Respondent's mother, and to a lesser extent, Respondent's staff and the EMS technicians, contradict the husband. However, the expert testimony was that the symptoms of a cerebellar infarct, which is the kind of stroke suffered by the patient, can vary depending on a number of factors. Respondent's medical staff, his mother, and the EMS technicians could have confused the patient's stroke symptoms with the symptoms of her pre-existing medical conditions, which included poor balance and an unnatural gait, as well as the effects of anesthesia--especially since they did not have knowledge of the details of the procedure performed by Respondent or the medical significance of those details. Based on all the evidence, it appears that the patient suffered a cerebellar infarct early in the evening, during or shortly after the procedure, and that the stroke progressed in waves over time. In this scenario, a blockage in small blood vessels of the brain initially deprives the tissues directly served by those vessels of oxygen. In no more than six hours of being deprived of oxygen, the brain tissue dies. As tissues die from oxygen deprivation, they swell, which compresses and closes off nearby blood vessels, depriving additional tissue of oxygen, and the process continues in waves. As the stroke progresses, it becomes more and more debilitating. Respondent argues that the evidence is consistent with either a stroke caused by the cerebral angiogram, with no contribution from the infusion of BMA, or an immediate, massive stroke caused by the patient's fall at her house. As to the latter argument by Respondent, there was a contusion on the patient's face as a result of her fall, but it was minor, and it is unlikely to have caused an immediate, massive stroke. It is much more likely that the patient's stroke was caused by the procedure. As to the former argument, there is a one percent chance that a cerebral angiogram will produce a stroke, even if performed flawlessly. However, in this case, the chances are much greater that the patient's stroke was caused by the infusion of BMA. (The absence of evidence of BMA in the brain on autopsy is explained by the action of naturally-occurring macrophages that clean up the dead tissue and other foreign matter, which would have decomposed and eliminated evidence of the BMA.) Count I - Standard of Care The evidence was clear and convincing that Respondent's stem cell treatment provided to D.F. on March 24, 2010, fell below that level of care, skill, and treatment which, in light of all relevant surrounding circumstances, is recognized as acceptable and appropriate by reasonably prudent similar health care providers. No such health care provider would have provided the treatment, which almost certainly would result in a serious stroke. The evidence was clear and convincing that Respondent's care after the stem cell treatment provided to D.F., on March 24, 2010, fell below that level of care, skill, and treatment which, in light of all relevant surrounding circumstances, is recognized as acceptable and appropriate by reasonably prudent similar health care providers. Any such health care provider would have recognized the likelihood of a serious stroke and, if the procedure was attempted contrary to the standard of care, would not have then left the patient with his CVT and medical staff; rather, emergency transfer to an appropriate hospital setting would have been required. Count II - Adequate Medical Records DOH attempted to prove that Respondent's medical records were inadequate because they did not substantiate that he was attempting to treat conditions capable of responding to intra-cranial infusion of stem cells. That allegation was not proven by clear and convincing evidence. Respondent's medical records indicated that he also was attempting to treat neurological deficits other than peripheral neuropathy that could be treated with appropriate intra-cranial infusion of stem cell (assuming informed consent). No medical records could justify the procedure Respondent attempted on D.F. on March 24, 2010. Count III - Informed Consent DOH contends that the patient did not give informed consent, in part, because Respondent did not test to ensure that the autologous BMA to be infused actually contained stem cells. However, Respondent has conducted a trial to confirm the efficacy of BMA as a source of stem cells. There is medical and scientific literature documenting this, and Respondent's non-physician stem cell expert testified that BMA is an efficacious source of stem cells. DOH did not prove that the autologous BMA infused in the patient was devoid of stem cells, or that it did not contain enough to be efficacious. DOH also contends that the patient did not give informed consent, in part, because Respondent infused BMA, not a processed BMAC product. The signed consent forms themselves proved this allegation clearly and convincingly. The evidence also was clear and convincing that, taken together, the written consents did not adequately inform the patient of the true risk of the treatment Respondent proposed. They informed the patient regarding the risks of aspiration of bone marrow from the iliac crest, a cerebral angiogram using contrast, and the infusion of a processed BMAC product; they implied that the procedure Respondent proposed would not entail any greater risks. The evidence was clear and convincing that Respondent did not give the patient unwritten information regarding the proposed treatment or its risks. To the contrary, in defending against the allegations in this case, Respondent has denied that there was any additional risk. Count V - "Wrong Procedure" DOH attempted to prove that the procedure performed by Respondent had no basis in medicine or science and was a wrong procedure, in part, because he performed it to treat peripheral neuropathy, which would not respond to intra-cranial infusion of stem cells. However, taken together, the evidence was that Respondent proposed the procedure to treat neurological deficits, other than peripheral neuropathy, that could be treated with appropriate intra-cranial infusion of stem cells (assuming informed consent). Respondent presented the testimony of its non- physician stem cell therapy expert, evidence concerning medical and scientific literature about stem cell treatment, and evidence of a trial conducted by Respondent on the efficacy of BMA as a source of stem cells. This evidence proved that intra- cranial infusion of stem cells to treat neurological deficits in the brain and central nervous system, while innovative and perhaps investigational, has a medical and scientific basis and can be appropriate under certain circumstances, including informed consent. Respondent's evidence also proved that BMA is an efficacious source of stem cells and sometimes achieves results as good or better than processed BMAC products. However, Respondent's evidence did not address or refute DOH's clear and convincing evidence that there is no medical and scientific basis for the treatment Respondent attempted to perform on D.F. on March 24, 2010, which clearly was a "wrong" procedure.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order adopting the Findings of Fact and Conclusions of Law, revoking Respondent's license, and imposing a $20,000 fine. DONE AND ENTERED this 11th day of March, 2013, 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 11th day of March, 2013.
The Issue The issues are whether, during 2015, Respondent held himself out as a “doctor of medicine,” even though he did not hold a license to practice medicine in Florida, in violation of section 456.072(1)(m), Florida Statutes (2014); whether, during 2015, Respondent exceeded the scope of his advanced practice registered nursing (APRN)1 license modifier by removing adipose tissue from a patient’s abdomen, performing intravitreous injections of the processed tissue into both eyes of a patient, and failing to have a protocol in place for the removal of abdominal adipose tissue and the intravitreous injection of any material into a living person, in violation of section 456.072(1)(o); and, if so, the penalty that should be imposed.
Findings Of Fact The Parties Petitioner is the state agency charged with regulating the practice of nursing pursuant to section 20.43, and chapters 456 and 464, Florida Statutes. Respondent was born and raised in Cuba, where he obtained a licensed practical nurse degree and, in 1995, Respondent earned a Doctor of Medicine degree and moved to Florida. On two occasions, Respondent failed to pass the examinations in Florida for licensure as a medical doctor. Respondent obtained a Florida license as a registered nurse in 2005 and, in March 2015, a license modifier as an APRN. Respondent’s highest relevant education in the United States is a Master of Science degree in nursing awarded in December 2014 from the south Florida campus of the University of Turabo. A couple of months later, the American Academy of Nurse Practitioners certified Respondent as a Family Nurse Practitioner. The transfer of processed fat tissue into the eye is thought, by some, to treat conditions of the eye, such as dry macular degeneration, to be part of regenerative medicine. This so-called “stem cell injection procedure” (“procedure”) comprises three steps: (1) removing the fat tissue, usually from the abdomen; (2) processing the fat tissue to prepare it for injection; and (3) injecting the processed fat tissue into the vitreous cavity at the back of the eye. Following the completion of his medical education in Cuba, Respondent obtained varying degrees of training and experience in the each of the three steps of the procedure. Respondent testified that he trained with a “specialist,” possibly an ophthalmologist, in intravitreal injections. This covered such topics as the choice of syringe, the preparation of the patient, maintaining an open eye, the choice of a substance to stabilize the inside and outside eye, and the angle of the needle to the surface of the eye at the point of injection. Respondent also obtained training in intranasal and intraarterial injections, the latter of which is the more complicated. Respondent obtained a certificate in Mexico for completing the training in the removal of tissue from bone marrow. Respondent did not detail his training or experience in processing removed fat tissue. Through much of Latin America, Respondent has injected processed fat tissue, at the rate of about ten patients over one week, and has trained other healthcare providers to perform these procedures. Respondent also testified that he had performed a dozen intravitreal injections of processed fat tissue in Mexico and Chile prior to the three injections at issue in this case, so it seems that most of his experience did not involve intravitreal injections. Respondent’s only evidence of purported “stem cell” experience was assisting in bone marrow aspiration, not surgical adipose tissue removal or intravitreal injections. Respondent admitted that he had never performed intravitreal injections under the supervision of an ophthalmologist, a medical doctor of any type, or in a supervised training program prior to performing intravitreal injections on Patients E.K., E.N., and P.B. in May and June of 2015. Respondent failed to provide any evidence that he was educated or supervised by a licensed physician in the performance of these procedures prior to performing them on Patients E.K., E.N., and P.B. Performance of the Procedure by Respondent at the Clinic Respondent’s first intravitreal injection of fat tissue at the Clinic took place in April 2015, about one month after he had completed the educational requirement for this APRN license modifier. Having retained Respondent as an independent contractor, the Clinic called him a few days before an upcoming intravitreal stem cell injection to confirm his availability. The Clinic paid Respondent $500 per procedure, for which it charged each patient $5000. Although the Clinic operated this program as an FDA- registered clinical trial, all procedures were “patient funded treatment,” and the Clinic was not affiliated with any educational or research institution investigating stem-cell treatment of eye diseases or disorders. The three patients involved in this case are, or were, E.K., P.B., and E.N. E.K.’s procedure took place on May 15, 2015, and P.B. and E.N.’s procedures took place on June 16, 2015. Each patient suffered from dry macular degeneration. Each patient was sighted at the time of the procedure, at the end of which, each patient was substantially blind. At the time of each patient’s procedure, E.K., who died five years after her procedure, was 89 years old and resided in Oklahoma. P.B. was 77 years old and resided in southwest Florida, and E.N. was 72 years old and resided in Missouri, where she had taught research methods to graduate students at the University of Missouri. At the time of the subject procedures, the Clinic was affiliated with Bioheart, Inc., a publicly traded corporation. Key employees of the Clinic included Kristin Comella, who served as the chief scientist of the Clinic and chief scientific officer of Bioheart and holds bachelor’s and master’s degrees in chemical engineering, and Dr. Antonio Blanco, who is an internist in Hollywood, Florida, with 26 years of practice and the medical director of the Clinic and holds a medical degree from Georgetown University. The Clinic’s website adds that Ms. Comella is in the top 50 of global stem-cell influencers. E.K. and E.N. testified that they learned about or confirmed their interest in the Clinic by an online search of clinical trials of stem-cell treatment for dry macular degeneration. Neither patient differentiated between patient-funded clinical trials, such as these, and clinical trials whose treatment costs were subsidized by research centers, universities, hospitals, and pharmaceutical manufacturers. E.K.’s medical records do not include any representations as to Respondent’s status as a healthcare provider. E.K. and her niece, who accompanied her, arrived in Fort Lauderdale in sufficient time for E.K.’s pre-operative appointment with Dr. Greenbaum, an ophthalmologist employed with the Hollywood Eye Clinic. Until she spoke with Dr. Greenbaum, E.K. believed that Dr. Greenbaum would perform the procedure, based on what she had been told by Clinic staff. At the pre-operative exam conducted by Dr. Greenbaum, E.K. and her niece learned that Dr. Greenbaum would not be performing the procedure on the following day. Dr. Greenbaum mentioned Respondent’s name, so the niece had her husband research Respondent that night, but his research revealed nothing. The next day, E.K. and her niece were introduced to Respondent by a Clinic employee, likely Ms. Comella. The niece does not recall if the employee referred to Respondent as a physician, but she assumed that he was. She recalled only that the clinic employee introduced him by saying that he was very experienced and had performed lots of stem cell injections of this type. The niece recalled distinctly that Respondent introduced himself as a “medical doctor.” Respondent denies doing so. The niece’s testimony is credited based on the totality of the evidence. P.B.’s medical records do not include any representations as to Respondent’s status as a healthcare provider except for the operative report, which bears Respondent’s signature above “Physician Signature.” Well prior to the date of the procedure, P.B. called the Clinic, spoke with Dr. Greenbaum and Ms. Comella, who informed her that Dr. Greenbaum would perform the procedure. P.B. later arrived in Fort Lauderdale in time for her pre-operative exam by Dr. Greenbaum, whose office told P.B. that Dr. Greenbaum was no longer performing the procedure. P.B. assumed that another ophthalmologist would perform the procedure. The next day, P.B. and a friend or family member, who had accompanied her on the trip, met Ms. Comella and Respondent, whom Ms. Comella introduced as “Doctor Perez,” and he did not correct her. P.B. asked him if he was an ophthalmologist, and Respondent replied, “no, but I’m well-trained in this procedure.” He never mentioned that, in terms of Florida licensing, he was only a registered nurse or APRN and was not a physician. E.N.’s medical records include the most references to Respondent’s status as a healthcare provider. These records include a page from the Clinic’s website that was initialed and dated by E.N., and prominently identifies Respondent as a “DM, NP-C,” meaning “doctor of medicine” and “nurse practitioner--certified.” The accompanying text discloses that “Dr. Alejandro Perez” graduated from the University of Havana Medical School in 1993 as a “Doctor in Medicine”; since 2007, he has conducted innovative research on regenerative medicine with a focus on adult stem cells from bone marrow and adipose tissue; “Dr. Perez” has worked on adult stem cells to treat multiple chronic diseases; “Dr. Perez” trains national and foreign “Medical Doctors” on the use of adult stem cells; and that “[h]e currently holds a National Board Certification as a Family Nurse Practitioner.” In three out of five references, the document refers to Respondent as a “doctor,” never disclosing that he was not a licensed physician in Florida. This website page may have come into existence after Respondent’s first patient encounter in this case in May 2015. Ms. Comella introduced Respondent to E.N. and her sister, who had accompanied her on the trip, as “Dr. Alex Perez.” Without stating his specialization, Respondent told E.N. that he was a “medical doctor” and was proud of his “profession,” which, in context, meant the practice of medicine, not nursing. Respondent wore a white jacket with a printed name tag, “Alex Perez, M.D.” At no time did Respondent reveal that his Florida licensure was as a registered nurse or APRN and not a physician. Lack of a Written Protocol As a licensed APRN, Respondent was required by section 464.012 and Florida Administrative Code Rule 64B9-4.002 to practice under an APRN protocol filed with the Board of Nursing. At all times material, the scope of practice of a certified family nurse practitioner licensed in Florida as an APRN did not include performing any invasive procedures, including surgical removal of adipose tissue or intravitreal injections, without an APRN Protocol on file that ensured physician supervision. By letter dated March 12, 2015, the Board of Nursing notified Respondent that he was required to have an approved APRN protocol on file with the Department “within 30 days of employment.” Respondent was employed in March 2015 at the time of receipt of the above-referenced letter. In May and June 2015, Respondent was aware of the protocol requirement and the scope of practice as an APRN. He admitted that he received the March 12, 2015, letter and failed to provide a protocol as instructed. At no time did Respondent ever obtain or file with the Board of Nursing a written protocol between him and a supervising licensed physician authorizing Respondent to perform the subject procedure. Respondent claimed, alternatively, that Drs. Greenbaum and Blanco served as his supervising physicians, but admitted that they served remotely and without a signed written protocol. Harm to the Patients The impact on the three patients of this unauthorized procedure performed by Respondent was blindness and its incumbent, incalculable damages, including, but not limited to, loss of independence, loss of mobility, and loss of enjoyment of life. Respondent admitted that, if not for the procedure, the three patients would likely not have been blind.2
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Nursing enter a final order finding that Respondent has violated sections 456.072(1)(o) and 456.072(1)(m) and revoking Respondent’s license to practice as an advanced practice registered nurse. DONE AND ENTERED this 3rd day of May, 2021, in Tallahassee, Leon County, Florida. S MARY LI CREASY Administrative Law Judge 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 3rd day of May, 2021. COPIES FURNISHED: Dirlie Anna McDonald, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399 Nicole M. DiBartolomeo, Esquire Department of Health Office of the General Counsel 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399 Louise St. Laurent, General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399 Dwight Oneal Slater, Esquire Cohn Slater, P.A. 3689 Coolidge Court, Unit 3 Tallahassee, Florida 32311 Joe Baker, Jr., Executive Director Board of Nursing Department of Health 4052 Bald Cypress Way, Bin C-02 Tallahassee, Florida 32399 Deborah McKeen, BS, CD-LPN Board of Nursing Department of Health 4052 Bald Cypress Way, Bin D-02 Tallahassee, Florida 32399
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant facts are found: At all times relevant to this proceeding, respondent, Manihi G. Mukherjee, has been a licensed physician in Florida, holding license number ME 0027749. She received her medical degree in New Delhi, India, in 1965. Respondent is Board certified in obstetrics and gynecology and is a Fellow of the American College of OB/GYN. She attends conferences regularly and has attended more than 150 hours of continuing medical education courses between 1979 and 1987. Since 1976, she has been in private practice in St. Petersburg, Florida, specializing in obstetrics and gynecology. Respondent first saw patient J.B. on November 30, 1979, for a routine gynecological examination and renewal of birth control pills. While obtaining an initial history on the patient, respondent learned that J.B. had a previous appendectomy performed in 1973, and noted the surgical incision located in the right lower quadrant. During a visit to respondent on or about September 9, 1980, J.B. told respondent that she wanted more information' about methods of contraception other than birth control pills. Respondent advised J.B. about the various alternative methods of contraception, including tubal ligation, as well as their effectiveness and complications. With regard to tubal ligation, respondent explained to J.B. that a bilateral partial salpingectomy using a mini-laparotomy could be performed for sterilization purposes and that the failure rate of such a procedure was 4 to 6 persons per 1,000. A laparotomy procedure involves the creation of an incision of about 8 to 10 inches in the anterior abdominal wall. A mini-laparotomy involves a smaller incision of between one and three inches. A salpingectomy is the removal of the fallopian tube. A partial salpingectomy is the removal of a portion of the fallopian tube. A bilateral partial salpingectomy is the partial removal of both fallopian tubes. On or about April 1, 1981, J.B. returned to respondent for a six-month check up, and advised respondent that she wanted to have a tubal ligation. Respondent again advised J.B. about the method of tubal ligation which would be used (the mini-laparotomy with bilateral partial salpingectomy) as well as the complications and failure rates of the procedure. Thereafter, on April 14, 1981, J.B. was admitted to what is now known as Humana Hospital Northside in St. Petersburg Florida, for elective tubal ligation. On that date, she signed a form entitled "Consent to Operation, Administration of Anesthetics, and the Rendering of Other Medical Services," authorizing respondent to perform a mini-laparotomy and a bilateral partial salpingectomy. While obtaining a further medical history from J.B. at the hospital prior to the scheduled surgery, respondent was informed that the patient had previously had an exploratory laparotomy in 1973, at the same time that the appendectomy was performed. On or about April 15, 1981, respondent performed a mini-laparotomy and what was described in respondent's records as a "bilateral partial salpingectomy" with a modified Pomeroy procedure on patient J.B. A Pomeroy procedure is a method of sterilization accomplished by picking up a loop of the fallopian tube, clamping across the loop, cutting and removing that portion of the loop above the clamp and ligating, or tying off, the tissue beneath the clamp with catgut sutures. Respondent modified the procedure by using chromic O sutures. In performing the surgery, respondent identified the left tube and ovary and ligated the loop of the tube. She then attempted to locate the right tube and ovary. Respondent visualized a distorted right tube, but did not see a right fimbria or a right ovary. The fimbria is the fringe-like outer end of the fallopian tube. Respondent testified that she assumed that the patient's right ovary and tube had been removed during the patient's previous exploratory laparotomy and/or appendectomy. Respondent sent specimens from what purported to be the right and left fallopian tubes to the pathology department for pathological evaluation. Her dictated operative report describes the following: "Operative Findings: On opening the abdominal cavity, her right tube was blocked, fibrial (sic) end was absent. Right ovary was absent. Left tube and ovary looked normal. Ovaries looked normal. Operative Procedure: . . . Both tubes were identified. They were held in their mid portion with the Bab- cock and transfixed with chromic O catgut suture... The loop of the right and left fallopian tube were transected and sent separately to the lab..." The pathological evaluation was performed on or about April 16, 1981. It revealed that the specimen identified as "Specimen A," which purported to be a portion of the right fallopian tube, contained sections of veins and fibrofatty tissue. Specimen A did not contain tubal matter. Specimen B contained, as expected, a portion of the left fallopian tube. The respondent was advised of the pathology evaluation report, though the time of such advice was not established. Patient J.B. remained hospitalized until April 7, 1981. Shortly after performing surgery on J.B., respondent advised J.B. that during the course of the operative procedure, respondent could not find a right ovary. However, she advised J.B. that there was nothing to worry about and that everything went well. After leaving the hospital, J.B. saw respondent on three more occasions. On April 20, 1981, respondent removed the staples from J.B.'s abdomen. She advised J.B. to remain on birth control pills for healing purposes. On May 15, 1981, and on June 8, 1981, respondent saw J.B. for postoperative visits. At the latter visit, J.B. advised respondent that she would be moving to Louisiana because of her husband's job. At no time did respondent advise J.B. that the pathological evaluation of the specimens submitted from the April 15, 1981, surgery revealed that the specimen purporting to contain a portion of tubal matter from the right fallopian tube did not in fact contain such material. At no time did respondent advise J.B. that respondent believed that the right tube was removed during the previous surgery performed in 1973. Respondent did not advise J.B. that she could become pregnant if the right tube were note properly blocked, and, therefore, that she needed to remain on birth control pills until the matter could be appropriately investigated. Respondent did not advise J.B. of the necessity to "follow-up" on the results of the pathology report by either obtaining records from the 1973 surgery to confirm respondent's belief that the patient's right fallopian tube was previously removed or by performing appropriate testing on J.B. to confirm blockage of the right ovary. On or about June 20, 1981, well after being apprised of the results of the pathological evaluation, respondent dictated a Discharge Summary for the hospitalization of J.B. from April 14-17, 1981. The Discharge Summary provided in pertinent part: Hospital Course: On April 15, 1981, a mini-laparotomy and partial bilateral salpingectomy was performed without any complications under general anesthesia. Postoperatively, the patient did fairly well. She was discharged on the second postoperative day with the advice to be seen in the office in one week. The Discharge Summary contained no reference to the results of the pathological evaluation. It also contains no documentation that respondent believed that the patient's right fallopian tube was removed during the 1973 surgery. On or about September 29, 1981, patient J.B. telephoned respondent's office because her period was two weeks late and a home pregnancy test had given a positive result. J.B. was informed that it was unlikely, but not impossible, that she was pregnant, and that with a tubal ligation procedure, a part of each tube is removed. On or about October 2, 1981, J.B. went to a physician in Louisiana and was determined to be pregnant. On October 7, 1981, she had an elective abortion. Following the termination of pregnancy, a diagnostic laparoscopy and a D & C (a scraping of the uterus) was performed on October 20, 1981. The laparoscopy revealed that the right ovary was present and a cyst was on the ovary. The right fallopian tube was present in its entirety (including the fimbria), was surgically untouched and was otherwise normal. The injection of methylen blue dye revealed that the fallopian tube was open and not blocked. A failed tubal ligation is not in and of itself malpractice or substandard care. However, a reasonably prudent physician, under the circumstances present in this case, should have immediately advised the patient that the possibility existed that one of the tubes had not been properly ligated, and, therefore, the possibility existed that the patient might become pregnant. The patient should have been advised to continue utilizing birth control methods until appropriate investigation could be undertaken to determine the condition of the right fallopian tube. A reasonably prudent physician would have then undertaken appropriate investigation. This could have included either the obtaining of previous medical records to confirm or deny that the right fallopian tube had been removed during the earlier surgical procedures performed in 1973, or the performance of a hysterosalpingogram. This latter procedure is a test which involves the injection of radiographic dye into the uterus and through the tubes. The dye is examined under x-ray to determine whether it flows freely through the fallopian tube or is stopped by blockage or ligation. The respondent admits that the term used in J.B.'s medical records to describe the procedure performed on the patient during her April, 1981, hospitalization was incorrect. Respondent did not perform a bilateral salpingectomy as noted in the Discharge Summary, but instead performed a left partial salpingectomy and excision of the tissue from the right tube. On September 5, 1981, patient R.L., an 18 year old female, was admitted to the emergency room complaining of abdominal pains. After examining the patient, the emergency room physician determined that R.L. was suffering from bilateral lower quadrant tenderness in the abdomen. A pelvic examination revealed bilateral tenderness in the adnexa and tenderness in the cervix. The impression of the emergency room physician was that R.L. had pelvic inflammatory disease (PID). PID is a progress of infection in the reproductive organs which can start in the vagina and spread to the cervix and progress upward to the uterine cavity, continue on outward to the fallopian tubes and involve the pelvis, either by direct continuous spread or through the blood supply and the lymphatics. It may be associated with either a bacterial or a viral type of infection. The emergency room physician ordered several tests to be conducted for the patient, including a complete blood count test. This test revealed that the patient's white blood cell count was 17,500. A normal count is approximately 7,800. R.L.'s white blood cell count was significantly elevated, indicating the presence of an infective process. The emergency room physician contacted the respondent, who agreed to assume the care of patient R.L. Respondent ordered the admission of the patient to the hospital, with a diagnosis of PID with peritonitis. Peritonitis is an inflammation of the peritoneum or lining of the abdomen. Upon admission, the respondent obtained an initial medical history and performed an initial physical examination on R.L. The medical history revealed that the patient had never had children, had been on birth control pills for one and one-half years, and she denied having had sexual intercourse for the past four months R.L. informed respondent that she had started having abdominal pain and a low-grade fever on the morning of the day before and that the pain had become increasingly worse and generalized, associated with some nausea and vomiting. The respondent's examination of the patient's abdomen and a pelvic examination revealed vague distention or bulging of the abdomen, muscle guarding and rigidity. Sluggish bowel sounds were audible, and there was marked tenderness and rebound tenderness in the patient's lower abdomen. The respondent's impression was acute PID with peritonitis. She ordered that R.L. be placed on intravenous fluids, that her vital signs be taken four times a day, that a chest x-ray be given, and that pain medication, aspirin, and antibiotics be administered. The respondent's main objective was to try to resolve the patient's PID conservatively, without performing surgery. R.L.'s daily progression varied with respect to her white blood cell count, her temperature, abdominal tenderness and rigidity, bowel sounds and daily activity between September 5 and 14, 1981. The patient's white blood cell count fell to 13,100 on September 7, and rose to 16,700 on September 9th. Her temperature would rise and fall on any given day. Her abdomen remained distended and rigid until September 12, when she began having less tenderness and better bowel sounds. She showed some improvement in her diet intake and in ambulation. The respondent ordered that various tests and changes of medication be performed between September 6 and 14, 1981. These included a urinalysis, a flat plate x-ray of the abdomen, an ultra sound of the abdomen and changes in antibiotics. On September 10, respondent performed a culdescentesis (the insertion of a needle into the cul-de-sac under general anesthesia), and withdrew ten cubic centimeters of frank pus. On September 11, respondent performed a colpotomy (a procedure in which an incision is made into the cul-de- sac through the upper wall of the vagina, into the peritoneal cavity) in order to drain the cul-de-sac. The patient appeared to improve somewhat after this procedure. On September 14, 1981, respondent requested Dr. Benjamin Abinales to perform a surgical consultation. Dr. Abinales' examination of R.L. on September 14 revealed that R.L.'s abdomen was slightly distended, with marked tenderness. He noted muscle guarding and rebound tenderness, and the presence of peristalsis. Dr. Abinales felt that the patient was suffering from pelvic peritonitis, and recommended that respondent continue the present plan of treatment for several days. If no improvement was evident, Dr. Abinales suggested that exploratory surgery be considered. The patient's condition did not improve after September 14th. Her white blood count value rose to 27,800 and her temperature was as high as 101 degrees on September 15, 1981. E-coli bacteria, usually found in the gastrointestinal system, were revealed from cultures performed on the pus drained during the culdescentesis. On September 16, the responded performed a second colpotomy, again draining frank pus. On September 17, R.L. was administered a new type of antibiotic, and this was changed again on September On September 18, a chest x-ray revealed that there was a possibility of a subphrenic abscess on the left side of the lungs with pleural effusion present. Thereafter, specialists in infectious diseases and pulmonary medicine were consulted. The infectious disease specialist recommended a CT Scan of the abdomen and surgical intervention after the CT Scan results were evaluated. On September 21, 1981, respondent and Dr. Abinales performed an exploratory laparotomy, lysis of extensive intestinal lesions, what was described as "removal of tubovarian abscess from the right side," an appendectomy, drainage of subphrenic abscess on the left side, and peritoneal lavage. The operative description of the exploratory laparotomy demonstrates that there was significant inflammation of the fallopian tube and the ovary on the right side and also significant inflammation of the appendix on the right side. Thus, the etiology of the infection could have been either an appendicitis with perforation or a tubo-ovarian abscess. Patient R.L. recuperated uneventfully after the surgery and was discharged from the hospital on October 4, 1981. Where possible, conservative treatment (non-surgical treatment) is the treatment of choice for PID. This is particularly true for young female patients of child bearing years. The accepted standard of practice for gynecologists is to initially pursue conservative treatment of PID with antibiotic therapy, especially in the presence of peritonitis, for a period of about 72 hours. Generally, if the proper antibiotics are administered, PID responds dramatically within 72 hours. If clinically significant improvement does not occur in that period, other complications, such as appendicitis or abscess formation, should be suspected and exploration of the abdomen surgically is necessary. The extent of surgical intervention required depends, in large part, on the condition of the abdomen as revealed on exploratory laparotomy. While a physician should be concerned about making every effort to preserve the reproductive organs in a young female, the need to preserve the reproductive system must be balanced against the need to preserve the patient's life, particularly where peritonitis exists.
Recommendation Based upon the findings of fact and conclusions of law recited herein, it is RECOMMENDED that respondent Manihi G. Mukherjee, M.D. be found guilty of violating Section 458.331(1) (m) and (t) , Florida Statutes, that she pay a fine o $2,500.00 and that she be placed on probation for a period of three years, with conditions and restrictions to be established by the Board of Medicine relating to her surgical assessment and care of patients and her record keeping. Respectfully submitted and entered this 28th day of September, 1988, in Tallahassee, Florida. Diane D. Tremor, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1500 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 28th day of September, 1988. APPENDIX TO RECOMMENDED ORDER CASE NO. 87-2283 The parties' proposed findings of fact have been fully considered and are accepted and/or incorporated in this Recommended Order, with the following exceptions: Petitioner 7. Rejected as irrelevant and immaterial to the issues in dispute. 13. Rejected as irrelevant and immaterial to the issues in dispute. 40. First sentence rejected as irrelevant. 49. Second sentence rejected as irrelevant. 61(b). Second sentence rejected as unsupported by competent, substantial evidence. 63. Rejected as unrelated to the charges in the Administrative Complaint. Respondent (as to J.B.) 11. Rejected as contrary to and inconsistent with the greater weight of the evidence. 13, 14, 15 and 17. Rejected as contrary to and inconsistent witch the greater weight of the evidence. (as to R.L.) 4. Rejected as unsupported by competent, substantial evidence. First sentence rejected as unsupported by the evidence. Rejected as contrary to the evidence. 9, 10 and 11. Accepted, except with regard to timeliness. 12. Rejected, as contrary to the greater weight of the evidence. COPIES FURNISHED: Stephanie A. Daniel Senior Attorney Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Donald V. Bulleit and Nelly Ehouzam Fowler, White, Gillen, Boggs, Villareal & Banker, P.A. P. O. Box 210 St. Petersburg, Florida 33731 Dorothy Faircloth Executive Director Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Bruce D. Lamb, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
The Issue The issue in this case is whether Petitioner is entitled to an award of attorneys' fees and costs pursuant to Section 57.111, Florida Statutes, and Rule 60Q-2.035, Florida Administrative Code.
Findings Of Fact Based upon the record in this proceeding, the following findings of fact are made: At all times pertinent to this proceeding, Petitioner, Jules G. Minkes, was licensed as an osteopathic physician in the State of Florida having been issued license number 0S001516. For purposes of this proceeding, there is no dispute that Dr. Minkes qualifies as a small business party as defined in the FEAJA. In approximately May of 1988, the Department of Insurance notified the Department of Professional Regulation of a closed claim regarding Dr. Minkes. 2/ Specifically, the notice advised that an indemnity had been paid on behalf of Dr. Minkes to a patient T. G. (the "Patient") in the amount of $150,000 in settlement of a claim that Dr. Minkes had allegedly failed to diagnose and treat the Patient's basal cell carcinoma. The Department assigned an investigator to the case who notified Dr. Minkes of the investigation by letter dated June 26, 1988. The investigator interviewed Dr. Minkes and Dr. Munzer, a dermatologist who treated the Patient upon Dr. Minkes' referral. The Investigator also obtained the Patient's medical records from Dr. Minkes and several other physicians who treated her. From the outset of the Investigation, Dr. Minkes' maintained that the Patient had lied in connection with her claim. The investigator did not interview the Patient nor her husband, nor did the Investigator contact any of the individuals identified by Dr. Minkes as having knowledge of the case. The notes of the Investigator's interview with Dr. Minkes and the Patient's medical records were sent to an osteopathic physician with similar credentials to Dr. Minkes, a specialist in internal medicine. Joseph H. Rosin, D. O., was the expert retained by the Department to review Dr. Minkes' treatment of the Patient. In a report dated January 18, 1989, Dr. Rosin opined that Dr. Minkes' care of the Patient did not meet community standards. In particular, the Report noted that the Patient had a clear history of invasive basal cell carcinoma and Dr. Minkes failed to provide adequate treatment when it was known to have reoccurred. Dr. Rosin stated that it was not the standard of care in the community for an internist such as Dr. Minkes to treat extensive basal cell carcinoma, that surgical intervention and proper follow-up care by a dermatologist was necessary and the Patient's locally invasive carcinoma, which had been confirmed by a biopsy performed by Petitioner, should have been treated in a more timely and appropriate manner. After the consultant's report was obtained, the investigative file was completed and sent to Tallahassee for review by the investigator's supervisors in Tallahassee. The complete investigative report was reviewed and approved by the investigator's supervisor on January 31, 1989. On June 7, 1989, the Department's investigative file was forwarded to members of the Probable Cause Panel (the "Panel") of the Board along with a copy of the Department's recommendation to find probable cause and a copy of a proposed Administrative Complaint. The Panel, consisting of one lay member from the Board who was serving as chairman of the Panel and a licensed osteopathic physician, met on June 16, 1989. Both members acknowledged that they had received the materials sent to them and had reviewed the materials prior to the meeting. An assistant attorney general was present to answer any questions concerning the Panel's duties and/or the proper interpretation of the applicable laws or rules. A prosecuting attorney for the Board was also present to discuss the Department's recommendation to file an Administrative Complaint. The transcript of the June 16, 1989 Panel meeting reflects little discussion of the case. The Panel members concurred with the Department's recommendation and authorized the filing of the Administrative Complaint against Dr. Minkes. The Department filed the Administrative Complaint against Dr. Minkes' license to practice osteopathic medicine on or about June 20, 1989. That Administrative Complaint included three charges. Count I charged Dr. Minkes with violating Section 459.015(1)(r), Florida Statutes, as a result of his alleged failure to refer the Patient to a specialist for adequate treatment of her basal cell carcinoma, thus exploiting her for his own financial gain. Count II charged Dr. Minkes with violating Section 459.015(1)(p), Florida Statutes, by failing to keep medical records justifying his course of treatment of the Patient. Count III charged Dr. Minkes with violating Section 459.015(1)(y), Florida Statutes, by failing to practice osteopathic medicine with that level of care, skill and treatment which is recognized by a reasonably prudent similar osteopathic physician as being acceptable under similar conditions and circumstances. Although the allegations in the Administrative Complaint are somewhat vague and ambiguous, it arguably charges Dr. Minkes with malpractice because he failed to refer the Patient for proper treatment of her basal cell carcinoma, he attempted to treat the Patient's growing recurring basal cell carcinoma himself even though it was a condition which the Administrative Complaint alleges should have been treated by a specialist in that area of medicine, and he ignored the Patient's basal cell carcinoma. Most of the allegations contained in the Administrative Complaint were consistent with and apparently based upon the allegations made in the civil complaint filed by the Patient and her husband against Dr. Minkes. A copy of the civil complaint was contained in the Department's Investigative File. (It was the settlement of that civil law suit which prompted the investigation by the Department.) The charge that Dr. Minkes had not referred the Patient to a specialist for treatment was also supported by the Department investigator's conversation with Dr. Munzer, whom Dr. Minkes had identified as the specialist to whom he had referred the Patient. A formal administrative hearing was held before the undersigned Hearing Officer pursuant to Section 120.57(1), Florida Statutes. Following the conclusion of that hearing, a Recommended Order was issued on December 13, 1990, recommending the dismissal of Count I, but recommending that a Final Order be entered finding Petitioner guilty of Counts II and III. As noted above, the Department's investigative file does not include any interviews with the Patient or her husband to confirm the allegations that were made in the civil law suit. However, the Department presented the testimony of the Patient's husband during the hearing in the Underlying Proceeding and, in addition, the previously transcribed testimony of the Patient was also accepted into evidence. (The Patient had died of unrelated causes prior to the hearing in the Underlying Proceeding.) As noted in Finding of Fact 35 of the Recommended Order, both the Patient and her husband testified that Dr. Minkes advised them that he could treat the Patient's basal cell carcinoma and that he in fact attempted to do so. If this testimony had been accepted as credible, it would have been sufficient when considered with the other evidence presented, to establish that Dr. Minkes was guilty of all of the allegations contained in the Administrative Complaint. However, after considering all of the evidence, that testimony was specifically rejected. Notwithstanding the conclusion that Dr. Minkes did not attempt to treat the Patient's basal cell carcinoma himself as alleged in the Administrative Complaint, the Recommended Order concluded that certain violations had been established. As set forth in paragraphs 8 through 13 of the Conclusions of Law, the undersigned Hearing Officer concluded that Dr. Minkes' records regarding the Patient were deficient and that his treatment fell below the standard of care expected of a reasonably prudent physician under similar conditions and circumstances. Dr. Minkes filed exceptions to the Recommended Order arguing that the factual grounds for the violations found in the Recommended Order were not specifically alleged in the Administrative Complaint. The Board apparently agreed with this contention since, in its Final Order, the Board adopted all of the Findings of Fact in the Recommended Order, but dismissed the charges in the Administrative Complaint. Some of the charges in the Administrative Complaint presume that Dr. Minkes attempted to treat the Patient's basal cell carcinoma. In particular, the Administrative Complaint refers to several instances when Dr. Minkes hyfercated lesions on the Patient's forehead. The Administrative Complaint suggests that these instances were improper attempts to treat the Patient's basal cell carcinoma. The evidence presented at the hearing was insufficient to overcome Dr. Minkes contention that his clinical observations justified his conclusions that these lesions were keratotic and not related to the Patient's basal cell carcinoma. This testimony by Dr. Minkes and the rejection of the testimony of the Patient and her husband on this matter undermined some of the fundamental presumptions in the Administrative Complaint. Nonetheless, the undersigned Hearing Officer concluded that the evidence was still sufficient to establish violations of the statutory provisions cited in Counts II and III of the Administrative Complaint. The Board's apparent determination that the violations found in the Recommended Order were not adequately alleged in the Administrative Complaint does not obviate the conclusion that violations of the charged statutes were found to have in fact occurred. Dr. Minkes complains that the consultant's opinion which led to the Panel's finding of probable cause indicates that Dr. Minkes did not refer the Patient to a specialist for treatment when, in fact, such a referral was made to Dr. Munzer. This matter was recognized in Findings of Fact 67 of the Recommended Order. As noted in that Finding, the consultant subsequently acknowledged the referral to Dr. Munzer and amended his opinion. The consultant still felt that Dr. Minkes failed to meet the applicable standard of care because he failed to take adequate steps to insure that the Patient's basal cell carcinoma was treated. It should be noted that there are many unresolved questions regarding the scope of Dr. Minkes' referral to Dr. Munzer. Dr. Munzer's statement to the Department's investigator and his deposition testimony offered into evidence during the Underlying Proceeding regarding his treatment of the Patient differed greatly from Dr. Minkes' version of the referral. Dr. Munzer claimed that he did nothing more than evaluate the Patient's biopsy. He claimed that he told Dr. Minkes that the Patient needed chemosurgery, but Dr. Minkes continued to treat her. Dr. Munzer disclaimed any responsibility for treating the Patient's basal cell carcinoma and states that he would not have agreed to treat her condition because he was not qualified to do so. In determining whether probable cause existed to file the Administrative Complaint, the Panel was not required to, and did not attempt to, reconcile this discrepancy between Dr. Minkes and Dr. Munzer. Dr. Minkes also points out that Dr. Tytler, whose opinion was not available at the time the Administrative Complaint was filed but whose subsequent deposition was accepted into evidence at the final hearing, testified that there was no indication in the Patient's medical records that Dr. Minkes ever treated or attempted to treat the Patient's basal cell carcinoma as alleged in the Administrative Complaint. However, Dr. Tytler did testify that Dr. Minkes' treatment of the Patient did not meet community standards in certain respects. Without question, there were some gaps and/or oversights in the Department's investigation. In retrospect, the Department perhaps should have recognized the possibility that the Patient's version of events might not be accepted in its entirety in which case the Administrative Complaint could have been drafted in a manner that would have minimized the impact of such a conclusion. Notwithstanding these deficiencies, there was sufficient evidence for the Panel to conclude that the Patient had received substandard care. Even if the Patient's own decisions contributed to the delay in treating her basal cell carcinoma, there was clearly a lack of understanding and/or miscommunication between Dr. Minkes and Dr. Munzer as to how the Patient was to be treated. While there were conflicting versions as to who was responsible for this breakdown in communication, there was some evidence considered by the Panel which would reasonably indicate that the violations alleged had indeed occurred. After considering all of the circumstances, it is concluded that the Department was substantially justified in filing the Administrative Complaint.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is ORDERED that Dr. Minkes' Petition for Attorney's Fees and Costs is DENIED. DONE AND ENTERED this 27th day of February 1995 in Tallahassee, Leon County, Florida. 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 27th day of February 1995.
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.
Findings Of Fact Petitioner took the examination for licensure as a laboratory supervisor in 1981, 1982, 1984 and 1985. In the fall of 1984 he passed that portion of the examination covering Immunohistology but failed the portion covering Supervision and Administration. His score on the Immunohemotology portion was 32 with 31 required for a passing grade. On the Supervision and Administration portion his score was 47 with 48 required to pass. On June 6, 1985, the rules affecting laboratory personnel licensing was changed to require candidates for the examination for which Petitioner applied to hold a bachelor's degree. Petitioner does not hold a bachelor's degree and acknowledged that he does not meet the current academic requirements to sit for the examination. Although the required procedures for making rule changes were followed by Respondent, Petitioner contends that he was not advised of the proposed changes, and, had he been so advised, he would have applied to retake the examination in Supervision and Administration before the rule changes became effective and would have qualified to sit for the examination. Respondent's witness presented Petitioner's record. This record shows that Petitioner, in October 1984 passed the Immunohistology portion of the examination and failed the Supervision and Administration portion by one point. This record also revealed that Petitioner applied to retake the examination in Supervision and Administration in January 1985 and sat for this examination in April 1985. On the examination his test score was 39 with 48 required to pass.
