Findings Of Fact Dr. Gans is a chiropractor licensed in Florida on the basis of examination. Dr. Gans prepared and filed an application for examination and licensure with the Florida State Board of Chiropractic Examiners. Dr. Gans answered the question on the application, "Do you have a chiropractic license in any state?" by stating: "Ohio - Mechanotherapy." The Ohio authorities recognized several professions whose functions would be included under the practice of chiropractic in Florida. Mechanotherapy generally would be limited to the practice of manipulation only. Dr. Gans was licensed in Ohio as a mechanotherapist. Dr. Gans answered the question on the application, "Have you ever been refused licensure in any state?" by stating, "No." Dr. Gans had applied for, taken, and failed the Ohio chiropractic examination whereupon he was not issued a license as a chiropractor by the State of Ohio. Dr. Gans was eligible to reapply to take the Ohio examination. At the time of his application to Florida, Dr. Gans had appealed the determination by the Ohio authorities that he had failed the Ohio examination.
Recommendation Based upon the foregoing findings of fact and conclusions of law, the Hearing Officer recommends that the Florida State Board of Chiropractic Examiners revoke the license of Ray E. Gans. DONE AND ORDERED this 2nd day of October, 1978 in Tallahassee, Florida. STEPHEN F. DEAN Hearing Officer Division of Administrative Hearings 530 Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: John R. Sutton, Esquire 250 Bird Road, Suite 310 Coral Gables, Florida 33146 Paul Lambert, Esquire 1311 Executive Center Drive Tallahassee, Florida 32301 C. A. Hartley, Director Florida State Board of Chiropractic Examiners Suite 202, Building B 6501 Arlington Expressway Jacksonville, Florida 32211
The Issue Whether Respondent violated Section 458.331(1)(t), Florida Statutes, and, if so, what discipline should be imposed.
Findings Of Fact At all times material to this proceeding, Dr. Ford was a licensed physician in the State of Florida. His license, numbered ME 0051042, was issued on July 8, 1987. Patient R.A.L, presented to the Emergency Department of Winter Haven Hospital (Hospital) at approximately 1:35 p.m. on October 9, 1997. R.A.L.'s initial chief complaint was right flank pain since 9:00 a.m. that day. He reported a history of vomiting and diarrhea and stated that it felt like a kidney stone, of which R.A.L. had a history. Right flank pain is common with a patient having a kidney stone or kidney problem. R.A.L. was initially examined by Dr. David Siegel about 30 minutes after R.A.L. came to the emergency room. On physical examination palpation, there was no flank pain, but R.A.L. did have moderate pain diffusely throughout all areas of his abdomen. His abdomen was not acutely distended, and there were normal bowel sounds. On Dr. Siegel's order R.A.L. was given Toradol intravenously at 2:22 p.m. to relieve the pain. Toradol is a non-steroidal anti-inflammatory drug. R.A.L. was also given fluids intravenously. R.A.L.'s symptoms did not provide Dr. Siegel with a definitive diagnosis. Dr. Siegel ordered the following tests to be performed: a complete blood count, an amylase, a urinalysis, a PTPDT, and X-rays of the abdomen. The complete blood count was done to make sure that the patient was not anemic and to see if there was an elevated white blood count, which would be indicative of some type of infection or acute abdominal process. The complete blood count showed a significantly elevated white blood cell count of 24.3. The test also revealed that there was a left shift of a differential, which means that there was a high differential percentage-wise of segmented and banded white blood cells. The combination of the significantly elevated white blood cell count and the left shift indicated that there was an acute infectious process or an acute illness. The amalyse test measures a serum enzyme that is secreted from the pancreas. If the serum enzyme is elevated, it could be indicative of pancreatitis. The amalyse test was normal. The urinalysis would show whether there was an infection and would show some abnormalities if there were a kidney stone. R.A.L.'s urine checked out normal. At 3:00 p.m. R.A.L. voided. His urine was strained, but there were no kidney stones present. R.A.L. did not have an adequate response to the Toradol. He was given Demerol intravenously at 3:10 p.m. Based on the test results, Dr. Siegel was unable to make a definitive diagnosis. Because of R.A.L.'s clinical condition and his continued pain, Dr. Siegel ordered an abdominal Computed Tomography (CT) scan to see if he could further define what was going on in R.A.L.'s abdomen. Because of the absence of flank pain, the elevated white blood cell count, and the normal urinalysis report, Dr. Siegel did not rule out the possibility of kidney stones, but did feel that some abdominal process of significance was higher on the list of possible diagnoses than kidney stones. Dr. Siegel went off duty at 5:30 p.m. and turned the care of R.A.L. over to Dr. Ronald Barbour. Dr. Siegel gave Dr. Barbour an oral report of his findings and indicated that he was primarily concerned about a serious intra-abdominal process. Before finishing his shift, Dr. Siegel dictated a written report, which was immediately transcribed and placed in R.A.L.'s chart. Dr. Siegel expected Dr. Barbour to get the results of the CT scan and determine whether the results would allow a diagnosis. When Dr. Barbour came on duty, he went to see R.A.L., who told Dr. Barbour that he was still having some pain. R.A.L. asked for something to relieve the pain, and Dr. Barbour ordered Demerol for him. Dr. Barbour received a call from the radiologist, who said that the CT scan was consistent with a small bowel obstruction. Dr. Barbour told R.A.L. that it appeared he had a bowel obstruction and that he would be admitted to the Hospital. It is the Hospital's policy to contact a patient's primary care physician when a patient is being admitted to the Hospital from the Emergency Department. Dr. Ford was R.A.L.'s primary care physician. Dr. Ford was called by an Emergency Department nurse. Dr. Barbour spoke with Dr. Ford and advised him that the CT scan showed a small bowel obstruction. Dr. Ford stated that he would admit R.A.L. No mention was made of a surgical consult during the conversation. Dr. Barbour did not call a surgeon for a consult because normally if the patient has a primary care physician, the primary care physician would choose the surgeon should a surgical consult be necessary. R.A.L. was admitted to the Hospital at approximately 8:45 p.m. At that point, the responsibility for the care and treatment of the patient shifted from Dr. Barbour to Dr. Ford. Dr. Ford gave admission orders to Lorina Duncan, a nurse in the Emergency Department. The orders included administering Demerol and Phenergan as needed and giving the patient a saline solution intravenously. Dr. Ford also ordered tests to be done the following morning. The nurse's notes do not indicate that Dr. Ford told her to order a surgical consult for the next morning. R.A.L. was given Demerol and Phenergan in the Emergency Department at 9:55 p.m. At 10:10 p.m. R.A.L. was signed out of the Emergency Department to the medical/surgical floor of the Street Building, which is known as Street One. When R.A.L. was admitted to the Hospital, his abdomen was not distended. By the time he was admitted to Street One, his abdomen was distended and firm, and he was complaining of abdominal pain and nausea. When he was placed in his bed, he positioned himself in a fetal position, which is indicative of being in pain. He had no bowel sounds. While the nurse was getting a medical history, R.A.L. was lethargic and would drift off in the middle of the admission questions. His breathing was shallow and rapid. It took the nurse over an hour to complete the admission assessment on R.A.L. after he had come to Street One. At 11:50 p.m., R.A.L. was complaining that his pain had increased throughout his stomach. He indicated that his nausea was better. R.A.L. requested a patient-control anesthetic (PCA), which allows the patient to administer a metered dose of pain medication to himself by pushing a button. Around midnight the nurse had the hospital operator page Dr. Ford. He returned the nurse's call. She told Dr. Ford that R.A.L.'s abdomen was distended and that he was lethargic. R.A.L. had had no pain medication administered since being admitted to Street One, and his next dose of pain medication was to be given at 1:00 a.m. The nurse told Dr. Ford that R.A.L. was complaining of pain and wanted to have a PCA. Dr. Ford gave an order for a Demerol PCA, which would allow a five-milligram dose every five minutes with a maximum of 150 milligrams in four hours. The nurse told Dr. Ford that R.A.L. had been complaining of nausea. Dr. Ford asked whether R.A.L. had vomited, and she advised the doctor that R.A.L. had not. They discussed the possible use of a naso-gastric (NG) tube, which extends from the nose down to the stomach. It is used to aspirate the contents of the stomach, which decreases nausea and distention. Dr. Ford did not order a NG tube. At 12:30 a.m., October 10, 1997, the Demerol PCA was started. At 4:30 a.m., R.A.L. was complaining of shortness of breath. His abdomen was more distended and firm. Dr. Ford was paged, and he gave orders for lab work to be done. At 4:45 a.m. R.A.L. went into distress and died. Dr. Ford arrived at the Hospital about 5:05 a.m. A small bowel obstruction is a condition characterized by the inability of gastrointestinal fluid and material to pass through the small bowel due to some sort of blockage. Symptoms include pain, nausea, vomiting and a change in or cessation of bowel sounds. Small bowel obstructions generally cause the bowels to become inflamed and swollen, which can lead to a cut off of the blood supply to the bowel and result in the rupture of the bowel. If the bowel ruptures, it is a very acute, life-threatening situation which must be treated rapidly. Small bowel obstructions are generally classified as a partial or simple obstruction, and a complete or strangulated obstruction. A strangulated small bowel obstruction means the vascular system has been compromised and the blood supply to a part of the bowel has been cut off. If the blood supply has been cut off, the bowel tissue will become gangrenous, then necrotic, and finally die. Surgery can alleviate the strangulation. Strangulated small bowel obstructions represent 20 to 40 percent of all small bowel obstructions. Post-operative adhesions, bands of scar tissue which form inside the abdomen, are the predominate cause of strangulated bowel obstructions. Severe and constant pain, as opposed to cramping, intermittent pain, can characterize a strangulated small bowel. A strangulated small bowel is a very serious condition. Diagnosis requires obtaining a careful history, recognition of previous operations, a "hands on" physical examination and diagnostic testing. With a small bowel obstruction, a patient’s condition can change rapidly, sometimes in a matter of hours. Because any change in the condition of the patient can indicate a significant problem, serial abdominal examinations are important. Early detection and evaluation of complications from small bowel obstructions are also important. In the case of R.A.L., the level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances would have been for Dr. Ford to come to the Hospital and physically examine R.A.L. when the patient was admitted to the Hospital under his care and after Dr. Ford was called by the nurse around midnight, apprising him of R.A.L.’s condition. Dr. Ford did not come to the Hospital to examine from the time R.A.L. was admitted to the Hospital under his care to the time R.A.L. died. A strangulated bowel is a surgical emergency. If a physician fails to diagnose and treat a strangulated small bowel, the patient will likely die. The physician will normally consult a surgeon when the patient presents with a small bowel obstruction. In performing a surgical consult, the surgeon will make the determination of whether and when to perform surgery. The sooner the surgeon is involved, the less the chances of compromising the patient’s bowel or general physical condition. Calling a surgeon early in the course of treating a patient with a small bowel obstruction is the prudent thing to do. In the case of R.A.L., the level of care, skill, and treatment, which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances, would have been for Dr. Ford to call for a surgical consult when R.A.L. was admitted to the Hospital under his care. Dr. Ford did not call for a surgical consult from the time R.A.L. was admitted to the Hospital under his care to the time R.A.L. died.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding that Ronald A. Ford, M.D. violated Section 458.331(1)(t), Florida Statutes, placing him on two years' probation, imposing an administrative fine of $5,000, and requiring him to take five hours of continuing medical education in the area of risk management and 16 hours of continuing medical education in the area of diagnosing and treating abdominal and gastrointestinal disorders. DONE AND ENTERED this 5th day of February, 2002, in Tallahassee, Leon County, Florida. ___________________________________ SUSAN B. KIRKLAND Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 5th day of February, 2002. COPIES FURNISHED: Robert C. Byerts, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 William B. Taylor, IV, Esquire McFarland, Ferguson & McMullen 400 North Tampa Street Suite 2300 Tampa, Florida 33620 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Theodore M. Henderson, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
The Issue Whether Respondent committed the offenses described in the Administrative Complaint? If so, what disciplinary action should be taken against him?
Findings Of Fact Based upon the record evidence, the following Findings of Fact are made: Respondent is now, and has been since October 18, 1977, a physician authorized to practice medicine in the State of Florida under license number ME 0013979. He is a board certified dermatologist and dermapathologist. Respondent's practice is located in St. Lucie County. He is the only dermapatholgist in the county. E.M. is a former patient of Respondent. He is a fair complected retiree with red hair who has lived his entire life in areas that have warm and sunny climates. Fair complected individuals are more prone to develop skin cancers as a result of exposure to the sun than are their darker complected counterparts. E.M. had been treated for skin cancer on several occasions, dating back to some time between 1954 and 1960, before becoming Respondent's patient. In June of 1988, E.M. became concerned about two lesions that he had in a dime-sized area on his left forearm below the elbow. The lesions were scaly and crusted in texture, pea-sized in diameter, irregularly shaped, reddish in color and sensitive to the touch. E.M.'s concern led him to make an appointment to see Respondent. His initial visit to Respondent's office was on June 29, 1988. Because he was a new patient, E.M. filled out a medical history form before going into the examining room. Respondent did not give E.M. a complete physical examination. He examined only E.M.'s left forearm. His examination revealed the lesions about which E.M. was concerned. These were not the only lesions Respondent discovered on E.M.'s left forearm, however. By all appearances, the lesions on E.M.'s left forearm were pre- cancerous growths. There was no evidence of any ulceration, discharge, bleeding or other indication that these lesions were malignant. Having no reason to suspect that these lesions were cancerous, Respondent determined that they were solar keratoses, which are pre-malignant growths that appear on the superficial layers of sun damaged skin. E.M. had told Respondent before the examination that he had previously used Efudex, which is a chemotherapeutic drug used in the treatment of solar keratoses. Accordingly, at the time he made his diagnosis, Respondent knew that E.M. had a history of pre-cancerous growths. As a general rule, Respondent treats growths of the type he found on E.M.'s left forearm with cryosurgery1 and cauterization.2 If, after two or three such treatments, sufficient progress has not been made, he will then perform a biopsy to determine if there are cancerous cells in the deeper layers of the skin. In accordance with his usual practice, Respondent, during E.M.'s first visit on June 29, 1988, treated the lesions on E.M.'s left forearm, which Respondent reasonably believed to be pre-cancerous growths, with cryosurgery and cauterization. He then gave E.M. a cortisone cream to apply to the treated areas to aid the healing process. An appointment for a follow-up visit was made for July 13, 1988. Respondent next saw E.M. on July 13, 1988. His examination of E.M.'s left forearm on July 13, 1988, did not reveal any evidence of a malignancy, however, he did determine that there was a need to, and therefore he did, perform additional cryosurgery. Respondent sent E.M. home with a cream that contained not only cortisone to aid in healing, but an antibiotic as well to prevent against infection. An appointment for a second follow-up visit was made for July 27, 1988. E.M.'s next visit to Respondent was on July 27, 1988. Respondent's examination of E.M.'s left forearm on July 27, 1988, revealed that the treated areas were slowly healing. Based upon his examination, he had no reason to suspect a malignancy. Nor was there any indication that further cryosurgery was necessary. Respondent noted a flat, pigmented lesion in close proximity to the areas on E.M.'s left forearm that had been treated during his two previous visits. Respondent was not particularly concerned about this lesion,3 but he nonetheless mentioned to E.M. that it might be a good idea to have it biopsied to be on the safe side. E.M. responded that he preferred that such a biopsy not be performed. Respondent did not pursue the matter any further during the visit. Once again, Respondent gave E.M. a different cream to apply to the areas that had been treated. This time it was a pure antibiotic ointment. An appointment for a third follow-up visit was made for the morning of Wednesday, August 10, 1988. Respondent typically schedules biopsies and excisions on Wednesday mornings. E.M. cancelled his August 10, 1988, appointment with Respondent. He did not make another appointment. Accordingly, Respondent did not see E.M. as a patient again. In failing to biopsy the lesions on E.M.'s left forearm, which he had no reason to suspect were cancerous, Respondent did not act in a manner that was inconsistent with what a reasonably prudent physician with his training and experience would have done under like circumstances. More than a year later, in September, 1989, E.M. noticed that a lesion on his left forearm had opened and was draining. E.M. went to see Dr. Gary Marder, an osteopathic physician who specializes in dermatology. Marder suspected a malignancy. Accordingly, he performed a biopsy and scheduled E.M. for surgery. The initial biopsy report indicated an "invasive moderately differentiated squamous cell carcinoma." After Marder surgically excised the area, the pathologist revisited the matter and changed his diagnosis to an amelanotic melanoma, which is a rare type of melanoma4 that is characterized by an absence of pigmented cells. Pigmented lesions, like the one Respondent noticed on E.M.'s left forearm during E.M.'s July 27, 1988, visit, are not precursors of amelonotic melanomas. It was subsequently determined that the cancer had spread. Cancerous lymph nodes were removed from E.M.'s axilla in April, 1990, and from his elbow in November, 1990.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that the Board of Medicine enter a final order dismissing the instant Administrative Complaint against Respondent in its entirety. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 23rd day of January, 1992. STUART M. LERNER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 23rd day of January, 1992. 1/ Respondent uses liquid nitrogen to freeze and destroy the unwanted tissue. 2/ The cautery device that Respondent uses is battery-operated and produces a low current. It is particularly effective in removing rough, hard-crusted areas of skin. 3/ It did not even appear to be a pre-cancerous condition. 4/ Melanomas are one of the three types of skin cancers. Basal cell carcinomas and squamous cell carcinomas, which together account for 98% of all cancers, are the two other types. Of these three types of cancers, melanomas are the most destructive and the most likely to metastasize. 5/ Respondent has not been charged with failing to keep adequate medical records. 6/ Precisely what information E.M. provided on this form is unclear. 7/ The issue is not whether the practice described in this proposed finding is common, but whether it is acceptable. 8/ As noted above, the adequacy of Respondent's medical records are not at issue in the instant case. 9/ The Department did not advance this theory in the Administrative Complaint. APPENDIX TO RECOMMENDED ORDER IN CASE NO. 91-3696 The following are the Hearing Officer's specific rulings on the findings of fact proposed by the Department: Accepted and incorporated in substance, although not necessarily repeated verbatim, in this Recommended Order First sentence: Accepted and incorporated in substance; Second and fourth sentences: Rejected because they are more in the nature of summaries of testimony than findings of fact; Third sentence: To the extent that this proposed finding suggests that there was also a "pigmented lesion" on E.M.'s left forearm that Respondent observed during E.M.'s first visit to his office, it has been rejected because it is not supported by persuasive competent substantial evidence. Rejected because it would add only unnecessary detail to the factual findings made by the Hearing Officer.5 First sentence: Accepted and incorporated in substance;6 Second sentence: Rejected because, even if true, it would have no bearing on the outcome of the instant case. Rejected because, even if true, it would have no bearing on the outcome of the instant case. First sentence: Accepted and incorporated in substance; Second sentence: Rejected because it would add only unnecessary detail to the factual findings made by the Hearing Officer. Rejected because, even if true, it would have no bearing on the outcome of the instant case. Rejected because it would add only unnecessary detail to the factual findings made by the Hearing Officer. Rejected because, even if true, it would have no bearing on the outcome of the instant case. First sentence: Accepted and incorporated in substance; Second sentence, fragment before comma: Accepted and incorporated in substance; Second sentence, fragment after comma: Rejected because, even if true, it would have no bearing on the outcome of the instant case. 11-12. Accepted and incorporated in substance. 13. Rejected because, even if true, it would have no bearing on the outcome of the instant case. 14-17. Accepted and incorporated in substance. Rejected because, even if true, it would have no bearing on the outcome of the instant case.7 First sentence: Rejected because it would add only unnecessary detail to the factual findings made by the Hearing Officer; Second sentence: Accepted and incorporated in substance. First sentence: Accepted and incorporated in substance; Second sentence: Rejected because it is more in the nature of a summary of testimony than a finding of fact; Third sentence: To the extent that this proposed finding suggests that Respondent believed that the pigmented lesion was a squamous cell carcinoma, it is rejected because it is not supported by persuasive competent substantial evidence. First sentence: Rejected because it is more in the nature of a summary of testimony than a finding of fact; Second sentence: Accepted and incorporated in substance; Third sentence: Rejected because it constitutes argument regarding the credibility of testimony rather than a finding of fact. Rejected because it would add only unnecessary detail to the factual findings made by the Hearing Officer.8 First sentence: Rejected because it is more in the nature of a summary of testimony than a finding of fact; Second sentence: To the extent that this proposed finding states that "E.M. had had several prior biopsies . . . [and therefore] was aware of the reasons for a biopsy," it has been accepted and incorporated in substance. To the extent that it suggests that Respondent never recommended to E.M. that a biopsy be performed on the pigmented lesion that Respondent observed on E.M.'s left forearm during the July 27, 1988, visit and that, if such a recommendation had been made, E.M. "would have willingly submitted," it has been rejected because it is contrary to the greater weight of the evidence. Rejected because, even if true, it would have no bearing on the outcome of the instant case. Accepted and incorporated in substance. First sentence: Rejected because it is not supported by persuasive competent substantial evidence; Second and third sentences: Rejected because they would add only unnecessary detail to the factual findings made by the Hearing Officer. First sentence: Rejected because it is more in the nature of a recitation of testimony than a finding of fact; Second sentence: Rejected because it would add only unnecessary detail to the factual findings made by the Hearing Officer. 28-29. Rejected because they would add only unnecessary detail to the factual findings made by the Hearing Officer. 30-34. Accepted and incorporated in substance. Rejected because it would add only unnecessary detail to the factual findings made by the Hearing Officer. Third sentence: Accepted and incorporated in subst ance; Remaining sentences: Rejected because they would add only unnecessary detail to the factual findings made by the Hearing Officer. Rejected because it would add only unnecessary detail to the factual findings made by the Hearing Officer. Rejected because, even if true, it would have no bearing on the outcome of the instant case. Rejected because it is contrary to the greater weight of the evidence. Rejected because, even if true, it would have no bearing on the outcome of the instant case.9 COPIES FURNISHED: Mary B. Radkins, Esquire Department of Professional Regulation 1940 North Monroe Street, Suite 60 Tallahassee, Florida 32399-0792 Shamsher Singh, M.D. 1701 Hillmoor Drive, #A-3 Port St. Lucie, Florida 34952 Dorothy Faircloth, Executive Director Board of Medicine Department of Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792 Jack McRay, General Counsel Department of Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792
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.
