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
Findings Of Fact The Respondent is a state agency which initiated a proceeding with the filing of an Administrative Complaint against Marc Richman, D.O. The said complaint was assigned to the Division of Administrative Hearings pursuant to a request for Administrative Hearing pursuant to Chapter 120 and was assigned Division of Administrative Hearing Case Number 88-5258. On June 24, 1989, the Department of Professional Regulations issued a notice of voluntary dismissal in the above captioned proceeding and dismissed all charges against Marc Richman, D.O., in that case. Marc Richman, D.O. is a prevailing small business party within the meaning of Section 57.111(3)(c) and (d). The amount of attorney's fees and cost sought by the Petitioner in the Petition for Attorney's Fees is reasonable for the Representation of Marc Richman, D.O., in the defense of the Administrative Complaint through the date of issuance of the Notice of Dismissal. The Department of Professional Regulation maintains that the proceeds (sic) above-captioned were substantially justified at the time the Administrative Complaint was initiated by the state agency in that it maintains that there existed a reasonable basis in law and fact at the time of the filing of the Administrative Complaint. This position is disputed by the Petitioner, Marc Richman, D.O. The request for attorney's fees in the amount of $8,572.00 and costs of $563.96 for a total of $9,225.96 is reasonable for the representation of Petitioner throughout the instant proceeding. These proceedings were initiated by the filing of a complaint on September 16, 1986 with the Department of Professional Regulation (DPR), Petitioner in Case 88-5258, by the parents of G.H. who died October 18, 1984. G.H. was a long time patient of Dr. Jaffee, D.O. who called in Dr. Richman, an orthopedic surgeon to consult and perform an arthodesis on the left ankle of G.H. to relieve constant pain. G.H. was a 34 year old male accountant who had suffered from juvenile rheumatoid arthritis since the age of 4. Although badly crippled he was able to lead a relatively independent life. As a result of his malady G.H. had for years taken steroid and corticosteroid medications. These medications depress the body's immune system and the ability to fight off infections. Accordingly, G.H. was at more than normal risk anytime he was exposed to infectious diseases. After Petitioner explained the procedure and the risks to G.H., the latter elected to have Petitioner perform the arthodesis. This operation consists of grafting bone into the ankle to stabilize that joint. The donor site chosen for the bone to graft to the ankle was the crest of the left ilium of the patient. This operation was successfully performed on August 2, 1984 at Metropolitan General Hospital, Pinellas Park, Florida. In the hospital on August 9, 1984, while G.H. was being adjusted in his bed, he felt a pop in his left hip and a large hematoma developed over the wound at the donor site. It is not unusual for hematomas to develop over surgical wounds but it is important that such conditions be closely watched because hematomas are a fertile field for an infection. The hematoma on G.H.'s hip showed no evidence of infection and G.H. was discharged from the hospital August 12, 1984 and sent home. Arrangements were made by Petitioner for Robert's Home Health Services, Inc. of Pinellas Park to send a nurse 3 times per week to check on G.H., take his vital signs, dress his wounds and attend to any other medical needs he may have. Verbal reports were made by the nurse to Richman reporting the condition of G.H. While being helped from his wheel chair into bed by his parents on or about August 15, 1984, G.H. apparently fell and caused additional bleeding of the wound on the left hip. On August 16, 1984 the nurse reported to Richman the additional bleeding and she was directed to have G.H. taken to the hospital to be seen by Richman. On August 16, 1984, Petitioner examined the wound, noted the reports that the hematoma was neither inflamed nor more tender, and that G.H.'s temperature had remained normal since the hematoma developed. He sent G.H. back home without further tests. The classic signs and symptoms of infection are redness, swelling, heat and pain. Redness of the skin due to intense hyperemia, is seen only in infections of the skin itself. Swelling accompanies infection unless the infection is confined to the bone which cannot swell. Heat results from hyperemia and may be detected even in the absence of redness. Pain is the most universal sign of infection. Along with pain goes tenderness, or pain to the touch, which is greatest over the area of maximal involvement. (Exhibit 12, Principals of Surgery, Fourth Edition). The hematoma on G.H.'s left hip between its inception and September 13, 1984 never exhibited any sign of infection. On September 6, 1984, G.H. reported to the visiting nurse that he had a pain in his stomach and didn't feel well. The nurse described this as having flu-like symptoms. This was reported to Petitioner and the nurse received no additional orders. On the nurse's next visit on September 10, 1984, G.H. reported his abdomen was still hurting and he didn't feel good. At this time his temperature was elevated at 101. The nurse called Dr. Jaffee's office and was told to have the patient admitted to Metropolitan Hospital. Upon admission to the hospital on September 10, 1984, G.H. was nauseous, vomiting, and had a high fever (103). He had no complaints regarding his ankle or iliac crest and the hematoma had decreased greatly. On September 13, 1984, while G.H. continued showing signs of infection (high fever) Petitioner operated on G.H. to remove the hematoma. At this time aerobic and anaerobic cultures were obtained. Forty-eight and seventy-two hours later these cultures had grown no infectious substance. Further studies and tests revealed that G.H. had bleeding ulcers and surgery was required to patch the ulcers. At this time the spleen was also removed. Following this surgery G.H. was more debilitated and with the precarious condition of his immune system he continued to go down hill until he expired on September 18, 1984. Cause of death was cardiac pulmonary arrest caused by candida septicemia. During the initial stage of the investigation, which was initiated some two years after the death of G.H., the investigator interviewed the parents of G.H., who had filed the complaint, and assembled the medical records including those kept by the home health agency. The parents contended that when the hematoma was removed by Dr. Richman he told the parents that he had found infection at that site. Dr. Richman denies making any such statement to the parents of G.H. and the medical records support the conclusion that there was no infection in the hematoma on September 13, when the hematoma was excised. The parents complained of the treatment that G.H. received from Drs. Jaffee and Richman as well as Roberts Home Health Services. Accordingly the investigation started with both Jaffee and Richman charged with malpractice by the parents of G.H. The investigator selected an orthopedic surgeon, Dr. Richard M. Couch, D.O., from DPR's consulting list and forwarded to him on January 7, 1987, the patient records of G.H. and requested he review those records and give his opinion on whether Drs. Jaffee and Richman diagnoses and treatment of G.H. was appropriate. In this letter (Exhibit 1) the investigator advised Dr. Couch that following surgery a hematoma developed, that after G.H.'s discharge from the hospital the hematoma ruptured and that G.H. was taken back to the emergency room where Dr. Richman saw the patient but found nothing significant about the hematoma. He also told Dr. Couch that when Richman cleaned out the hematoma he advised the family (of G.H.) that infection was found, and that, after this G.H. started internal bleeding which ultimately resulted in the patient's death. Dr. Couch responded to this request with two letters, the first of February 16, 1987 and a second on March 6, 1987. In his first letter Dr. Couch concluded that the iliac wound began draining on or about August 14, 1984 and cultures of this wound were not secured until after G.H.'s hospitalization on September 10, 1984. Since the hematoma was a post-operative complication he opined that Richman failed to adhere to certain tenets regarding wound care in this situation. However, Dr. Couch suggested the records be referred to an internist who reviewed the treatment provided by Dr. Jaffee. In his second letter Dr. Couch opined that Richman was at fault for not incising, debriding and draining the hematoma when it developed and for not taking cultures when Richman saw G.H. in the emergency room on later dates. He also found Richman at fault for not referring G.H. to a consultant in infectious diseases. A letter similar to the letter sent to Dr. Couch was sent by the investigator to Neal B. Tytler, Jr., D.O., an internist. Although the investigator contends he submitted the records maintained by Roberts Home Health Services in this case to Dr. Tytler it is obvious that before he submitted his report on June 5, 1987, Dr. Tytler had not read those records and was concerned regarding the absence of medical records during the period between G.H.'s discharge from the hospital on August 12, 1984, and his readmission on September 10, 1984. In his report Dr. Tytler carefully noted G.H.'s long term medication for juvenile rheumatoid arthritis and the serious side effects, viz depression of the immune system, which results from long-term steroid therapy. Recognizing the risk to G.H. from any surgery Dr. Tytler questioned the wisdom of the arthodesis but recognized that this was more of an orthopedic problem than an internal medicine problem. From the records received, Dr. Tytler concluded that G.H. developed a hematoma after his departure from the hospital and before September 6, 1984. Significantly, Dr. Tytler reported "Of concern to me is the apparent lack of records to document the events which transpired between August 12, 1984 and September 10, 1984. In this one month period an abscess formed at the surgical site and led to disastrous consequences. Unfortunately it can only be inferred that the first recognition of any problem occurred on September 6, 1984, when the patient developed `flu-like symptoms'. He was not examined and no one perceived that his problems were serious." When the probable cause panel met on June 25, 1988 to consider the charges against Drs. Jaffee and Richman, no probable cause was found as to Jaffee. One of the two members of the probable cause panel disclosed at the opening of the panel meeting that he knew Dr. Richman socially and that Richman had been his treating physician for a finger injury. He was excused from further participation and the hearing was tabled regarding Dr. Richman. At a subsequent panel meeting by telephone conference call, after a substitute lay panel member was selected and had been furnished the medical records, a vote was taken to find probable cause. The excerpt from those proceedings (Exhibit 8) shows that the DPR attorney opened the conference call by stating that Richman was charged with medical conduct falling below acceptable minimal standards and "at the last probable cause panel meeting you voted to find probable cause, and asked that administrative complaint be issued. At this time the Department recommends that you do find probable cause to believe that this violation exists." Following receipt of this erroneous information regarding the previous probable cause panel meeting, the Chairman, Mr. Wheeler, stated that after reviewing the entire file he believes probable cause exists to file an Administrative Complaint. Dr. Barker concurred. The case against Dr. Richman began to unravel when the deposition of Dr. Tytler was taken on February 24, 1989. Prior to taking this deposition Dr. Tytler had been provided records from Metropolitan General Hospital, records from Roberts Home Health Services and a copy of the Administrative Complaint. In response to questions regarding the treatment of G.H. as afforded by Dr. Richman, Dr. Tytler stated that a review of all medical records clearly demonstrated that after the hematoma developed at the donor site for the transplant no indication of infection ever appeared; that considering the medical history of G.H. and his high susceptibility to infection it would be more dangerous to the patient to evacuate the hematoma and risk additional infection than it would to continue to observe the hematoma and let it cure itself; that the cultures taken on September 13, 1984, when the hematoma was evacuated clearly and unequivocally demonstrated that the hip wound was not the source of the infection that ultimately led to the demise of G.H.; and that the treatment rendered by Petitioner was in all respects in conformance with required medical standards and procedures. Dr. Tytler further opined that treating an immune compromised patient with antibiotics without a specific infection in mind "could lead to the very scenario that caused his (G.H.) death", namely secondary infection. Further, with respect to the contention of Dr. Couch regarding the failure of Petitioner to take cultures at the hematoma site before September 10, 1984, Dr. Tytler opined that indiscriminate taking of cultures when no evidence of infection is present could result in a positive culture unrelated to the wound but which the doctor would be called upon to treat. This could invite a major change in therapy and an inappropriate prescribing of an antibiotic. Following the deposition of Dr. Tytler, DPR referred the medical records to another orthopedic physician and this doctor concurred with the opinion of Dr. Tytler that Dr. Richman's treatment of G.H. was not below minimally acceptable standards, that no malpractice was involved and that the treatment was in accordance with acceptable medical standards. The Department then dismissed the Administrative Complaint. In his deposition the physician member of the probable cause panel, James H. Barker, D.O., emphasized that his conclusion that probable cause existed to go forward with the Administrative Complaint was significantly influenced by the fact that no culture was done at the hematoma site. From his subsequent testimony it is clear that Dr. Barker was unaware, when he voted to find probable cause, that the culture taken from the hematoma site on September 13, 1984 was negative. The record clearly shows this to be a fact. As stated by Dr. Tytler in his testimony "hematoma yes; infection no." Dr. Barker was also concerned, and perhaps rightly so, that any time that someone goes in for an elective procedure and he dies "that alone makes you think there may be probable cause here." However, there must be factual evidence to support a finding of probable cause and here there was no such evidence.
The Issue Whether Respondent performed a wrong-site procedure in violation of section 456.072(1)(bb), Florida Statutes; if so, whether (and what) disciplinary measures should be taken against Respondent's license to practice medicine.
Findings Of Fact At all times relevant to this case, Dr. Lior, M.D., was licensed to practice medicine in the State of Florida, having been issued license number ME 74061, and was board-certified by the American Board of Dermatology. The Department has regulatory jurisdiction over licensed physicians such as Dr. Lior. In particular, the Department is authorized to file and prosecute an administrative complaint against a physician, as it has done in this instance, when a panel of the Board of Medicine has found that probable cause exists to suspect that the physician has committed a disciplinable offense. Here, the Department alleges that Dr. Lior committed one such offense. In the one-count Complaint, the Department charges that Dr. Lior violated section 456.072(1)(bb), "by performing or attempting to perform health care services on the wrong patient, a wrong-site procedure, a wrong procedure, or an unauthorized procedure or a procedure that is medically unnecessary or otherwise unrelated to the patient's diagnosis or medical condition." Dr. Akhtar's Examination On January 11, 2010, Patient S.L., a 74-year-old gentleman, presented to Asfa Akhtar, D.O., a general dermatologist employed by the Cleveland Clinic Florida, for an evaluation of a lesion inside his left ear. It was noted on that date that S.L. had a positive history for skin cancer. Dr. Akhtar performed a physical examination of S.L., and his contemporaneous note provides, in pertinent part, as follows: "Exam of the face, ears and hands reveal a pearly papule with rolled borders on the right helix."1/ On that date Dr. Akhtar's assessment included "R/O BCC-right helix." In other words, Dr. Akhtar wanted to rule out basal cell carcinoma on S.L.'s right helix. Dr. Akhtar's plan was to conduct a "shave biopsy." Prior to performing the biopsy, the location was marked with a pen and photographed. Dr. Akhtar then performed the biopsy by scraping skin cells of the surface skin of the suspicious area. The subsequent surgical pathology report provides, in pertinent part, as follows: Final Pathologic Diagnosis SKIN BIOPSY, RIGHT HELIX: NODULAR BASAL CELL CARCINOMA WITH SURFACE ULCERATION. TUMOR EXTENDS TO THE DEEP AND PERIPHERAL MARGINS OF BIOPSY. In correspondence dated January 20, 2010, Dr. Akhtar advised S.L. that the pathologic findings from the biopsy specimen of S.L.'s right helix confirmed a basal cell carcinoma. Dr. Akhtar recommended that it "be treated by a technique called Mohs Surgery to be certain as possible that it is completely removed." January 26, 2010 Consultation On January 26, 2010, S.L. presented to Dr. Lior for a Mohs surgical consultation. In addition to being board-certified in dermatology, Dr. Lior is qualified as a Mohs surgeon. On that date, Dr. Lior, who is also employed at the Cleveland Clinic, had access to the records of Dr. Aktar's office visit, the biopsy photograph, and the pathology report. Additionally, Dr. Lior's nurse, Diane Donner, LPN, obtained additional history from the patient. Specifically, Ms. Donner noted that, "[p]atient states he has surgery in the area approximately 3 years ago. It has been present for 3 YEAR(S)." Dr. Lior then performed an examination of S.L.'s right helix; however, her examination did not include the entire right helix. Specifically, Dr. Lior did not examine the top of the helix of S.L.'s ear. Instead, Dr. Lior conducted a "focused examination" on an observed scarred pearly papule on the helix of the right ear just superior to (above) the mid-line of the ear. Dr. Lior explained the methodology utilized in limiting her examination to a specific location on the helix, as follows: Q. . . . What information from those records would indicate where on that right helix that you just described that either the biopsy was taken or that there was biopsy- proven carcinoma? A. Right. So when we get that information, patient participation is expected. We ask the patient. We get a history. Then we also need to look at the area and see what looks consistent with the biopsy site as well. And so all of these things, when you actually see a cancer and you see a scar and you see the skin graft area, and the patient tells you that that's the site, you put it together with your biopsy pathology report, as well as your office notes. It's what we use all together. Based on Dr. Lior's experience, the observed papule was consistent with the clinical appearance of basal cell carcinoma. Dr. Lior credibly testified that S.L. pointed to the same area she was palpating and advised her that he had previously undergone Mohs surgery and that the cancer had returned. Dr. Lior discussed treatment options with S.L. and advised that Mohs surgery would be appropriate, to which S.L. agreed. Dr. Lior's record of the consultation provides in pertinent part, as follows: Physical Exam: Right superior helix: There is a 1 cm scarred, crusted, pearly papule. Impression: Biopsy-proven basal cell carcinoma. Patient notes this is recurrent. Plan: Therefore indicated for Mohs surgery. February 11, 2010 Mohs Surgery S.L. returned to Dr. Lior for the scheduled Mohs surgery on February 11, 2010. Upon entering the surgical room, S.L. was engaged in a conversation with Ms. Donner concerning the location of the site. Dr. Lior greeted and approached S.L., obtained the prior photograph, approached S.L.'s ear, and stated, "let's take a look." As she was attempting to match the photograph with the area of the ear, S.L. stated to Dr. Lior, "Don't you see the scar?" while simultaneously pointing to the location of the scar tissue. Dr. Lior indeed observed the scar tissue from the prior skin graft and again, like the January 26, 2010, consultation, noted the area was consistent with recurrent basal cell carcinoma. The location was noted to be just above the scar. Dr. Lior proceeded to palpate or touch the suspicious area. Thereafter, Dr. Lior proceeded to mark the intended surgical location on S.L.'s ear with a marker pen. Subsequently, a photograph of the marked location was obtained, the patient's informed consent was obtained, and an informed consent document was executed by S.L. A time-out was then performed where Dr. Lior and her assistant agreed upon the procedure and location. The surgical site was then sterilized and injected with lidocaine. At no time prior to the surgery did S.L. voice any concerns or objections related to the proposed surgical site. S.L. was not, however, provided a mirror to examine the proposed marked location. Additionally, there was no evidence that S.L. was shown a copy of the photograph obtained by Dr. Lior prior to surgery. Dr. Lior then proceeded to perform the Mohs surgery without incident. After completing the procedure, S.L.'s ear was bandaged and S.L. waited in a separate room while the excised portion of the ear was examined to determine whether there were "clear margins"--the absence of basal cell carcinoma. After completing the examination, Dr. Lior requested that S.L. return to the operating area to discuss the findings. When S.L. returned, Dr. Lior stated, "Good news, it's all clear, the margins are clear, there's no cancer, we're going to repair the area." In response, S.L. replied that, "[t]he site was not here, it was here." S.L. then bent the top of his ear down, and Dr. Lior observed--for the first time--a papule consistent with basal cell carcinoma.2/ It is undisputed that this newly-observed papule was the site of biopsy-proven basal cell carcinoma. Dr. Lior conceded that it was her plan, at the conclusion of the January 26, 2010, consultation, to perform a Mohs surgery on the site of the biopsy-proven basal cell carcinoma. She further conceded that, on February 11, 2010, she performed the Mohs surgery on a location of S.L.'s right helix different from the location that was the subject of the biopsy performed by Dr. Akhtar.3/ Dr. Lior offered to perform a Mohs surgery on the newly-observed/previously-biopsied location; however, S.L. elected to defer the procedure for a later date. Accordingly, Dr. Lior closed the existing excision site and performed a skin graft in the area. Dr. Lior provided S.L. with her contact information and informed S.L. that she would attempt to arrange for the Cleveland Clinic to withhold the charges for the surgical procedure performed. The Cleveland Clinic reversed the charges, as requested. S.L. declined to return to the Cleveland Clinic for suture removal or for any additional procedures.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding Respondent guilty of performing a wrong-site procedure and, therefore, violating section 456.072(1)(bb); and imposing the following penalties: a $1,000.00 fine, a letter of concern, five hours of risk management education, and a one-hour lecture on wrong-site surgery. DONE AND ENTERED this 20th day of May, 2013, in Tallahassee, Leon County, Florida. S TODD P. RESAVAGE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 20th day of May, 2013.
The Issue Petitioner Department of Professional Regulation seeks to suspend, revoke, or otherwise discipline respondent's license to practice medicine on charges of professional misconduct violative of Chapter 458 Florida Statutes (1979). The issues for determination are: Whether respondent is guilty of gross or repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances, in his treatment of Verdi Hammond Burroughs ("Burroughs") and Charles Kirk ("Kirk") in violation of Section 458.331(1)(t), Florida Statutes (1979); Whether respondent's treatment of Burroughs and Kirk was fraudulent and constituted misrepresentation, and whether the treatment was medically beneficial to the exclusion of other forms of proper medical treatment and was, therefore, harmful to the patient in violation of Section 458.331(1)(1), Florida Statutes (1979); Whether respondent violated Sections 458.331(1)(1), 458.331(1)(h), Florida Statutes (1979) by failing to fully inform Burroughs and Kirk (in his prescribing and administering Amygdalin [Laetrile]) of alternative methods of treatment for their cancer, and the potential of these methods for cure; whether each patient failed to sign a written release releasing respondent from liability; and whether respondent informed each patient, in writing, that Laetrile has not been approved as a treatment or cure by the Food and Drug Administration of the United States Department of Health and Human Services; Whether respondent's treatment of Burroughs and Kirk, when measured by the prevailing standards of medical practice in the community, would constitute experimentation on a human subject without first obtaining full, informed, and written consent, in violation of Section 458.331(1)(u), Florida Statutes (1979); Whether respondent failed to comply with Sections 458.333 and 458.335, Florida Statutes (1979); Whether metabolic therapy is recognized by a respectable minority of the medical profession as a treatment for cancer. Background By an eight-count administrative complaint dated March 31, 1982, petitioner Department of Professional Regulation, Board of Medical Examiners (Department), charged respondent Daniel J. Clark with multiple violations of Chapter 458, Florida Statutes (1979), the "Medical Practice Act." Respondent disputed the charges and requested a Section 120.57(1) hearing. On April 29, 1982, the Department forwarded this case to the Division of Administrative Hearings for assignment of a hearing officer. Hearing was then set for September 22 and 23, 1982. At hearing, the Department presented the testimony of Evelyn Kuhn, Daniel Clark, Alvin Edward Smith, Tammy Thompson, Brenda Kempton, and Lois Ann White. Petitioner's Exhibit Nos. 1/ 1-5 were received into evidence. The respondent testified in his own behalf and presented the testimony of Rodrigo Rodriquez, Rebecca Scholz, and Allen Bernsten. Respondent's Exhibit Nos. 1-5 were proffered but not received into evidence. The parties filed proposed findings of fact and post- hearing briefs by December 1, 1982. Those proposed findings which are incorporated herein are adopted; otherwise they are rejected as unsupported by the evidence or unnecessary to resolution of the issues. Based on the evidence presented at hearing, the following findings of fact are determined:
Findings Of Fact I. Respondent Since 1976, respondent has been licensed to practice medicine in the State of Florida, holding license number ME0026861. (Tr. 269; Prehearing Stipulation) He received a bachelor of science degree from Georgia Southwestern College and a medical degree from Medical College of Georgia. In 1975, he trained for five months with a gynecological oncologist in Americus, Georgia. In 1978, he completed a three year residency program at University Hospital in Jacksonville, Florida. (Tr. 266-268). Since 1979, he has practiced medicine in Ormond Beach, Florida. Initially, his practice included gynecology, family practice, and general nutrition. He then began to treat cancer patients with metabolic (nutritional) therapy. The purpose of such therapy is to enhance the immunological and biological capacities of a patient--nutritionally, immunologically, and physiologically--in order to improve the patients performance in combating cancer. This cancer treatment includes the administration of Amygadalin (Laetrile), vitamins, herbal teas and detoxifiers, and the application of salves and packs to cause localized hyperthermia. It is not a conventional, orthodox, or widely practiced form of cancer treatment. No other physician in Volusia County uses it. Most accredited medical schools in the United States do not teach it. The American Medical Association (AMA) considers it to be experimental. Eventually, respondent's metabolic treatment of cancer patients began to account for 15 percent to 20 percent of his practice. (Testimony of Clark, Rodriquez; P-3) II. Respondent's Treatment of Verdi Hammond Burroughs In October or November 1979, Nelson Murray, a chiropractor, asked respondent to examine Verdi Hammond Burroughs, a patient who had complained to Dr. Murray about a lump in her right breast. (The offices of Dr. Murray and respondent were close together in the same building. And, in the past, Dr. Murray had referred patients to respondent for medical treatment.) (Testimony of Clark, P-3). Respondent, who considered it an "across-the-hall consult," agreed. He went to Dr. Murray's office, examined Ms. Burroughs' right breast, and noted a small lump. He recommended that she have a biopsy or that she see a surgeon for a second opinion, to make sure that the lump was not malignant. (Subsequently, she failed to follow this recommendation.) Although he did not refer her to a particular surgeon, he looked up the names of several who might be willing to operate on her, as she was a Jehovah's Witness. (Since Jehovah's Witnesses object to blood transfusions, many surgeons refuse to operate on them.) (Testimony of Clark, P-3) During this brief examination, respondent did not perform any diagnostic tests other than to manually examine the breast. Although he kept meticulous patient medical records, he did not open a patient record on Ms. Burroughs or have her complete a patient history form. He took no progress notes during the examination. He did not consider her his patient, did not assume responsibility for her treatment, and did not charge her a fee. (Testimony of Clark; P-1, P-3). Respondent had no contact with Ms. Burroughs until Dr. Murray asked him to reexamine her in February, 1980. The circumstances were similar. Respondent examined her in Dr. Murray's office, noted the breast lump was unchanged, made no medical reports, and charged no fee. He recommended that she undergo a laboratory test, including complete blood chemistry, SMAC 22, CBC, and sedimentation rate. For this purpose, he specifically referred her to Dr. Nelson A. Murray, a medical doctor and pathologist in Jacksonville, Florida. (At that time, she lived in Jacksonville, Florida.) He also recommended, again, that she have a biopsy performed--a recommendation which she, again, failed to follow. (Testimony of Clark; P-3). On September 22, 1980, almost eight months later, chiropractor Murray again asked respondent to come to his office and examine Ms. Burroughs right breast. Respondent's subsequent examination revealed that the entire breast was severely inflamed and the nipple was inverted or sloping downward. The breast had the appearance of an inflamed carcinoma. Respondent strongly suggested that she have laboratory tests (the same tests which he had recommended earlier) done as soon as possible and that she arrange to see him immediately thereafter. He, again, told her that she needed a biopsy and gave a preliminary diagnosis of breast cancer. This time, she followed his recommendation. Two days later, she had the complete lab tests done by Dr. Murray, the Jacksonville pathologist. (Testimony of Clark; P-3). Respondent still did not consider Ms. Burroughs his patient or assume any responsibility for her treatment. During this September 22, 1980, examination, he did not open a patient file, take notes, or charge a fee. There is no evidence that Ms. Burroughs-- at that time--believed that she was his patient--or he, her doctor. Nor is there evidence that either party misunderstood or was confused about their relationship or their respective responsibilities. (Testimony of Clark; P-3). Between the February, ,1980 and September 22, 1980, examinations, respondent did not contact Ms. Burroughs and did not discuss her condition with chiropractor Murray. Between the November, 1979 and the September, 1980, examinations, respondent did not order or perform any further diagnostic tests on Ms. Burroughs and did not attempt to check with her to see if she had followed his recommendations. Neither did he expressly inform her that he was not her doctor. The Department contends that his failure to take these actions violates a generally accepted standard of medical care. (Testimony of Clark; P- 3) This contention, however, is unsubstantiated. The evidence does not demonstrate that the generally accepted standard of medical care required respondent to take such actions. Conversely, it has not been specifically shown how, and in what ways, respondent's treatment of Ms. Burroughs between November, 1979 and September, 1980, fell below an acceptable standard of medical care. 2/ Ms. Burroughs became respondent's patient on October 7, 1980, when she came to his office for medical treatment. He performed a complete work up, physical examination, and medical history, and reviewed the results of the lab blood tests. He concluded that her condition was essentially normal except for her right breast, which was severely inflamed and the nipple retracted. In addition, the lymph nodes under her right armpit' were palpable and enlarged. His initial impression was that she had inflammatory carcinoma (cancer) of the right breast with lymph gland involvement. He then scheduled her for a biopsy, which was necessary before he could determine the type of cancer involved. (Testimony of Clark; P-3) The biopsy was performed on October 9, 1980 by Dr. Kluger, a St. Augustine physician. It indicated an inflamatory intraductal adenocarcinoma of the breast, primary. Dr. Kluger, who felt that surgery was inadvisable because of the lymph node involvement, subsequently recommended to respondent that Ms. Burroughs undergo radiation and chemotherapy. (Testimony of Clark; P-1, P-3). During the October 7, 1980, office visit, respondent explained to Ms. Burroughs the alternative methods of cancer treatment, including their potential for cure. The methods discussed included surgery, radiation, chemotherapy, and metabolic therapy. She refused to undergo radiation or surgical treatment, explaining that her husband died of lung cancer after receiving surgery, radiation, and chemotherapy. She agreed however, to consider chemotherapy in conjunction with metabolic therapy. He explained to her that metabolic therapy was not a treatment against the cancer, per se, but that it would help "build up her body to where her own immune system would help her fight the cancer." (P-1). She agreed to accept this treatment--chemotherapy with metabolic therapy--then signed four separate affidavits on forms provided by respondent. The affidavits acknowledged her consent to the ordering and administration of Laetrile. Respondent, however, did not inform Ms. Burroughs in writing (by these affidavits or any other documents), that Laetrile has not been approved as a treatment or cure by the Food and Drug Administration of the United States Department of Health and Human Services. She also did not sign a written release, releasing him from any liability from the administration of Laetrile. (Testimony of Clark; P-1, P-3) During the October 7, 1980, visitation--after the affidavits were signed--respondent began treating her with metabolic therapy, consisting of Laetrile I.V., Vitamin C, B Vitamins, B-15, B-12, and crude liver injections. Metabolic therapy was commenced without obtaining her prior written consent. (Testimony of Clark; P-1). Several days later, on October 13, 1980, respondent began treating her with small doses of chemotherapy in conjunction with the metabolic therapy. The chemotherapy treatment plan was based on a phone call to Dr. Donald Cole, a New York oncologist. Respondent described the type and extent of Ms. Burroughs cancer and Dr. Cole recommended small 100 milligram doses of 5-FU twice weekly, two to five milligrams of Laetrile twice weekly, and 50 milligrams of Cytoxin PO orally. Respondent administered this regimen until he discontinued chemotherapy at the end of November, 1980. (Testimony of Clark; P-3). These doses and intervals of chemotherapy did not conform to the manufacturers' recommended doses contained in the Physicians Desk Reference, a standard reference used by practicing physicians. The doses administered by respondent were lower than those normally used in chemotherapy and are considered to be in the research or experimental stage. (Testimony of Clark, Smith). Chemotherapy and metabolic therapy are incompatible-- they work at cross-purposes. Chemotherapy drugs are strong immunosuppressants. They are toxic and intended to poison cancer cells; 3/ their effect is to suppress the body's immunological system. In contrast, the purpose of metabolic therapy is to enhance that same immunological system. (Tr. 215-216). For this reason, the use of chemotherapy is not included within the protocols for metabolic therapy found in International Protocols in Cancer Management. 4/ Respondent concedes that this publication is authoritative and contains the standard protocols for metabolic therapy. (Testimony of Rodriquez, Clark). Ms. Burroughs chemotherapy stopped at the end of November, 1980, but her metabolic therapy continued. By March, 1981, her right arm was beginning to swell because of enlarging lymph nodes. On the March 2, 1981, office visit, respondent told her that Laetrile was not stopping the cancer, and discussed restarting chemotherapy. He increased her Vitamin C, and began administering herbal cleaners and botanical medicines containing red clover, chapparral, myrr, goldenseal, yellow dot, juniper berries, yuva, ursaberries, conch grass, and dandelion. Respondent categorizes these medicines as blood purifiers, lymph purifiers, liver cleaners, and kidney cleaners. (P-3). By June, 1981, respondent believed the cancer had metastasized to Ms. Burroughs' right lung. During office visits in early June, he rubbed herbal ointment or liniment, Vitamins E and F, into her rib cage area. He also prescribed herbal packs and poultices to cause localized hyperthermia (heat increase). He prescribed dark and yellow herbal salves and instructed her to apply them to her right breast and underarm area, explaining that they would draw out and break down the cancer tumor. (Testimony of Clark, Kuhn; P-3). These salves--strong and painful--caused pieces of gray tissue to fall off her breast and underarm area. Respondent reacted by encouraging her, telling her that the salves were breaking down the cancerous tumor. (He now admits, however, that the herbal ointments and salves would have been ineffective in treating the cancer which had metastasized to her lungs.) He also prescribed a tea which tasted like black pepper. She forced herself to swallow it because he had told her that it would break up the cancer in her body. This representation was also untrue. (Testimony of Clark, Kuhn, Smith.) In administering metabolic therapy to Ms. Burroughs, respondent also prescribed whole-body hyperthermia for the purpose of stimulating her immune system. This required her to totally submerge herself in bath water which was as hot as she could tolerate. According to the standardized protocols for metabolic therapy, as stated in International Protocols in Cancer Management, such "whole-body hyperthermia, while successful in some cases, is dangerous and considered experimental." (Tr. 320, Testimony of Clark). Respondent's metabolic and chemotherapeutic treatment of Ms. Burroughs failed to conform to the standard of care recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. It fell below the prevailing and generally accepted standard of care recognized by his peers in the medical community: a.) After the diagnosis, respondent made an improper and incomplete staging 5/ of the disease by failing to take a liver scan, which would have revealed the existence (or nonexistence) of liver lesion. Cancer of the liver is deadly and must be dealt with immediately. (Tr. 89-92). b.) After he diagnosed Ms. Burroughs breast cancer, he failed to prescribe surgery or a combination of surgery and radiation therapy, treatment methods which likely would have been beneficial and controlled the disease. (Surgery, such as a radical mastectomy, does not cause a significant loss of blood, so blood transfusions--something Ms. Burroughs opposed--could have been avoided.) If necessary, chemotherapy--using conventional doses--could also have been administered. The chemotherapy and metabolic therapy which respondent provided Ms. Burroughs was probably worthless. The herbal salves and teas which he prescribed were incapable of drawing out or breaking up the cancerous tumor. c.) When Ms. Burroughs' cancer was diagnosed, it was in an advanced and complicated stage. Under such circumstances, a general practitioner (such as respondent) should have referred her to or obtained a consult from an oncologist, a specialist in the treatment of cancer. Respondent did neither. (Testimony of Smith). Metabolic therapy is not approved or recognized as acceptable for cancer treatment by a respectable minority of the medical profession. This finding is based on the opinion of Alvin Edward Smith, MD., board certified in oncology and internal medicine, and a Fellow of the American College of Physicians. He has treated cancer patients since 1978. His opinion on this issue is considered more credible than the contrary opinion of Rodrigo Rodriquez, M.D., who practices medicine in Tijuana, Mexico, who is not licensed to practice medicine in the United States, and who--other than acting as a guest resident at Kings County Hospital in Brooklyn, New York--has never practiced medicine in the United States. (Testimony of Smith, Rodriquez). III. Respondent's Treatment of Charles Kirk Charles Kirk became respondent's patient on August 13, 1980, and died shortly thereafter on September 9, 1980. Mr. Kirk, a 77-year-old male, was having great difficulty swallowing food and had a history of recurring choriocarcinoma of the larynx or throat. Surgery had been performed on him several times, and his larynx (voice-box) had been removed. Respondent explained to him the alternative methods of treatment, including surgery, chemotherapy, radiation, and metabolic therapy. Mr. Kirk opposed further surgery and objected to chemotherapy and radiation. He requested Laetrile. After he signed an affidavit provided by respondent (the same form which had been provided Ms. Burroughs), respondent ordered Laetrile. (Testimony of Clark; P-2). Respondent then referred him to a general surgeon for the placing of a gastrostomy feeding tube, a device which would enable him to swallow food and liquids. The tube was successfully placed surgically, after which respondent began administering Laetrile to him as part of metabolic therapy. The treatment was brief, only nine or ten days. On September 26, 1980, Mr. Kirk died. (Testimony of Clark; P-2). Mr. Kirk's condition, when he first became respondent's patient, was essentially irreversible; he was in the final stages of a fatal cancer. (Testimony of Clark, Smith; P-2). Respondent administered Laetrile to Mr. Kirk without first obtaining from him a release of liability and without informing him, in writing, that Laetrile has not been approved as a treatment or cure by the Food and Drug Administration of the United States Department of Health and Human Services. (Testimony of Clark.)
Recommendation Based on the foregoing, it is RECOMMENDED: That respondent's license to practice medicine be suspended for one year, for violating Section 458.331(1)(h), (1), (t), (u), Florida Statutes (1979). DONE AND RECOMMENDED this 9th day of March, 1983, in Tallahassee, Florida. R. L. CALEEN, JR. Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 9th day of March, 1983.
The Issue In an administrative complaint dated July 3, 1990, the Department of Professional Regulation (DPR) alleges that Respondent violated Section 458.331(l)(m) and (t), F.S., by failing to keep written medical records justifying a course of treatment, and by gross or repeated malpractice or the failure to practice medicine with that level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. More specifically, the complaint alleges that in his treatment of "Patient #1", Nabil Hilwa, M.D. failed to document in his patient's records the patient's difficulty urinating and the need for a transurethral resection of the prostate (TURP), and that he mislabeled patient #1's adenocarcinoma. The complaint also specifically alleges that Dr. Hilwa inappropriately diagnosed patient #1's condition because the emphasis in March 1985 should have been on the patient's nodule and a diagnosis of prostate cancer, either by transrectal or transperineal biopsy, and not on the TURP, and that Respondent should have performed an acid phosphatase and a prostatic specific antigen on patient #1. The issues for disposition are whether those violations occurred and, if so, what discipline is appropriate.
Findings Of Fact Except for two conclusory paragraphs, Respondent has admitted all factual allegations of the amended administrative complaint. These facts are thus established: Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.30, Florida Statutes, Chapter 455, Florida Statutes, and Chapter 458, Florida Statutes. Respondent is and has been at all times material hereto a licensed physician in the State of Florida, having been issued license number ME 0032104. Respondent's last known address is 6388 Silver Star Road, Orlando, Florida 32818-3235. From on or about March 5, 1985, to on or about April 22, 1985, and from on or about February 8, 1988, to on or about April 10, 1989, Respondent provided medical care and treatment to patient #1. On or about March 6, 1985, patient #1 was admitted to the hospital, with a complaint of difficulty urinating, for evaluation of prostatism, and Respondent subsequently performed a cystoscopy and found a one hundred percent obstruction of the prostatic urethra. On or about March 7, 1985, Respondent performed a Transurethral Resection of the Prostate (TURP). The pathology report revealed nodular hypoplasia without any evidence of malignancy. Respondent did not perform a prostate biopsy, an acid phosphatase, or a prostatic specific antigen. On or about April 22, 1985, patient #1 made his last postoperative visit after the TURP. On or about February 8, 1988, patient #1 presented to Respondent for evaluation of a prostatic nodule on the left prostatic lobe. Respondent advised patient #1 to have a prostatic sonogram with biopsy. On or about March 7, 1988, Respondent performed a transrectal sonography, which revealed a hypoechoic area, and a transrectal biopsy, which revealed a small focus of moderately differentiated adenocarcinoma of the prostate, on patient #1. Respondent did not perform an acid phosphatase or a prostatic specific antigen. On or about July 25, 1988, patient #1 was admitted to the hospital and Respondent performed a repeat prostatic biopsy, which revealed that adenocarcinoma of the prostate was present on all needle biopsy segments taken, in contrast to the biopsy performed on or about March 7, 1988. A sonogram was not repeated. On or about August 3, 1988, patient #1 was admitted to the hospital and Respondent performed a bilateral pelvic lymphadenectomy and a retropubic radical prostatectomy, which revealed the prostate had cancer up to the margin of resection. Respondent referred patient #1 to a radiation oncologist for a consultation. On or about August 3, 1988, Respondent's records indicate Respondent discussed the postoperative complications of impotence and urinary incontinence with patient #1. On or about March 23, 1989, patient #1 presented to Respondent with a complaint of gross hematuria. Respondent performed a cystoscopy which revealed hemorrhagic cystitis secondary to radiation. On or about April 10, 1989, patient #1 was doing well with no gross hematuria, and a repeat urinalysis was negative. 1985 -- First Referral of Patient to Dr. Hilwa for Evaluation and Treatment Don Buswell-Charkow (Dr. "B-C") is a physician who has practiced in the Orlando, Florida area since 1981. His field of practice is internal medicine. He is not and does not consider himself an expert in urology. A.C. (described as "patient #1" in DPR's Administrative Complaint and Amended Administrative Complaint) was a patient of Dr. B-C from March 10, 1983 to August 25, 1989. During the time period of 1983 to 1985, A.C. complained to Dr. B-C of urinary difficulty. On February 14, 1985, Mr. C. saw Dr. B-C for a sore throat and coughing. In the course of discussions, he mentioned that he was having difficulty with his bowels. Dr. B-C performed a rectal exam and felt an area which he described in his records as follows: "the left lobe of the prostate has a nodule." (Pet. Ex. 2) On March 1, 1985, Dr. B-C, by letter, referred Mr. C. to Dr. Hilwa for evaluation of his prostate. The letter stated: Would you please evaluate Mr. [C.'s] prostate. I felt the left lobe of his prostate had a nodule. A sigmoidoscopy was negative, a barium enema was negative, and an IVP showed enlargement of the prostate, though was otherwise normal. (Pet. Ex. #2) Including his training, Dr. Hilwa has specialized in the fields of urology and urological surgery for over 19 years. His specialty training includes post-graduate work in urology and urological surgery at Washington Hospital Center in Washington, D.C., a teaching facility affiliated with George Washington University; the University of Cincinnati Medical Center, a teaching facility; and Wayne State University, a teaching institution. Dr. Hilwa began his private practice in Orlando, Florida in 1978. The majority of his patients come from referring physicians. Approximately 25-30 physicians refer patients to Dr. Hilwa for speciality evaluation and treatment. Dr. Hilwa serves on the active medical staffs of AMI Hospital and West Orange Hospital. At AMI he is Chief of the Urology Department which consists of nine urologists. At West Orange Hospital, he is the Chief of Surgery (made up of approximately 15-20 physicians) and Chairman of the Surgical Practice Committee which addresses cases related to quality assurance matters. Dr. Hilwa has worked with the American Cancer Society as a Clinical Fellow at the University of Cincinnati where he performed research on cancer of the prostate and the significance of their serum acid phosphatase. He has also lectured for the American Cancer Society concerning cancer of the prostate. In addition, he has appeared on T.V. to discuss cancer of the prostate. In his practice, Dr. Hilwa sees approximately 1,000 patients a year for urological problems. Approximately 10% or 100 patients a year fall within the category of males with potential cancer of the prostate. He performs approximately 600 surgical procedures a year, of which approximately 60% fall within the category of major cases and 40% fall within the category of minor cases. To Dr. Hilwa's knowledge, he has never been (a) investigated by DPR (other than this case); (b) investigated or complained against by Medicare; (c) disciplined by any licensing agencies dealing with the practice of medicine; or (d) disciplined by any hospital with respect to hospital privileges. Dr. Hilwa has never had a patient with a diagnosis or suspected diagnosis of prostate cancer, other than A.C., complain to him with respect to his care and treatment. Neither has he had a referring physician tell him that someone had complained against him with respect to his care and treatment. On March 5, 1985, Dr. Hilwa first saw Mr. C. He personally took a history from him and documented in his records: "FREQUENCY 3X", "NYCTURIA [sic] 1-2X", decreased potency, "DRIBBLING YES", decreased stream force and caliber, and "HESITANCY YES". Upon physical examination of Mr. C.'s prostate, he found, according to his notes, that the prostate is 1+ enlarged; asymmetrical; and left prostatic nodule semi-firm. (Pet. Ex. #6, p. 70) Dr. Hilwa's use of the term "semi-firm" was not descriptive of "a cancerous feeling". "Semi-firm" is not a term he normally uses to refer to something that he would be suspicious of as cancer. His definition of a prostatic nodule that is cancerous is usually "firm or stoney-hard" -- not "semi-firm". The term "nodule" is a very broad term which signifies an aggregation of cells that may be anatomical or may be pathological. This definition is consistent with medical dictionary definitions of "nodule", e.g., Taber's Medical Dictionary. Dr. Hilwa's use of the term "nodule" in A.C.'s records referred to the left lobe of his prostate which was semi-firm and larger than the right. This is what he perceived as a "nodule". He did not feel an isolated, discrete, or raised surface on Mr. C.'s prostate gland. The term "induration" is a different feeling in the substance of the prostate than the surrounding tissue felt. Dr. Hilwa did not feel any induration on the surface of Mr. C.'s prostate in 1985. In Dr. Hilwa's practice, if he does find an induration he customarily draws a picture of it so that he will have a reference for himself. No such picture was drawn in 1985 in the case of Mr. C.'s prostate. The significance of finding an induration is that it provides a specific target towards which a biopsy needle may be directed. According to Dr. Hilwa, there was no discrete, isolated induration on the surface of A.C.'s prostate in 1985 to which he could have guided a biopsy needle. If he had performed such a procedure, it would have been a "blind biopsy". Following examination of A.C., Dr. Hilwa's initial clinical impression was "benign prostatic hypertrophy" which refers to a nonmalignant enlargement of cells of the prostate. His plan was to do a cystoscopy examination and a TURP if obstruction is present. Cystoscopy means looking inside the bladder through the urethra to determine whether or not there is obstruction. A TURP or transurethral resection of the prostate is a surgical procedure which involves cutting the interior tissue of the prostate gland. Prostatic stones are a hard, stoney substance. They can mimic a cancer or prostatic nodule. The finding of 100% obstruction upon cystoscopy examination of Mr. C. was consistent with documented symptoms in the medical records. In performing the TURP on Mr. Carty on March 7, 1985, Dr. Hilwa removed tissue and stones weighing a total of 13 grams. Following the cystoscopy and TURP, a pathology report was presented to Dr. Hilwa. It confirmed: (1) that he had dissected 13 grams by weight; (2) that the tissue removed was benign, and (3) that stones were present in Mr. C.'s prostate. On the basis of these findings, Dr. Hilwa's final diagnosis was benign prostatic hypertrophy. His hospital discharge summary, included in his office records for A.C., includes this statement: "...In view of the obstruction present and the patient's symptoms, it was felt that a TURP of the prostate is indicated rather than doing a biopsy of the prostate...". (Pet. Ex. #6, p. 115) Dr. Hilwa did not order a prostatic specific antigen test on Mr. C. because such was not available to him in 1985. The reason he did not do a serum acid phosphatase is that his diagnosis was benign prostatic hypertrophy. He had no reason to add this test, which often reveals false positives and false negatives. The TURP eliminated the obstruction found, as well as the multiple prostatic stones. Potential complications, if the prostatic obstruction and stones had not been removed by the TURP procedure, include worsening of the obstruction, irritation, recurring infection and surgery. A TURP is an accepted procedure in the field of urology for the elimination of prostatic stones and the elimination of an obstruction in the prostate. Dr. Hilwa saw Mr. C. on two occasions post-operatively in 1985: March 27, 1985 and April 22, 1985. He advised Mr. C. to come see him whenever he had any problems or needs. Otherwise he referred him back to his family physician, Dr. B-C. Dr. Hilwa had no further contact with Mr. C. from April 22, 1985 until February, 1988 -- approximately three years later. 1986 Re-evaluation of Patient By Dr. B-C On June 26, 1986, Dr. B-C examined Mr. C. and made the following notation in his records: "The rectal has a firm left lobe and normal right." (Petitioner's Exhibit #2) Dr. B-C was specifically looking for a prostatic nodule in Mr. C. in June of 1986. However, he did not palpate a nodule. He did not feel the same thing that he felt in 1985. On February 2, 1988, in his annual physical check up of Mr. C., Dr. B-C found the patient's prostate enlarged on the left and quite firm without a definite nodule. The right side was normal. 1988 -- Second Referral of Patient to Dr. Hilwa For Evaluation & Treatment Mr. C. was again referred by Dr. B-C to Dr. Hilwa for prostatic evaluation on February 8, 1988. Upon physical examination, Dr. Hilwa felt a one by one centimeter firm, left prostatic nodule. A picture was drawn on his medical records. It was not the same nodule that he felt in 1985 in Mr. C.'s prostate. It was a discrete, raised, distinct nodule surrounding prostatic tissue on the surface of the left lobe that he could measure with his finger. Dr. Hilwa's plan was to proceed with prostatic sonogram and biopsy. Mr. C. was scheduled for a sonogram on February 22, 1988, but did not show up. Two weeks later, the procedure was conducted. It revealed a hypoechoic area, which is an area that is usually characteristic of cancer of the prostate. The pathology report came back on March 9, 1988. It indicated that the vast majority of tissue was benign, except for a very small microscopic focus of moderately differentiated adenocarcinoma. Dr. Hilwa had Mr. C. come to his office where he explained his findings. Because Mr. C. asked a lot of questions and had a history of emotional illness, Dr. Hilwa pulled one of his textbooks, sat with him, went through all phases of cancer of the prostate, and described what he felt his situation was. Dr. Hilwa next commenced a metastatic workup involving x-rays of the abdomen and pelvis to determine whether the prostatic cancer was contained in the prostate or had spread outside. It was contained and had not spread. Next, Dr. Hilwa explained to Mr. C. the plan to repeat sonogram of the prostate with biopsy in two to three months. Another biopsy of Mr. C.'s prostate was performed on July 25, 1988. At that time, Dr. Hilwa felt clinically that Mr. C.'s cancer was stage B. The decision was made to proceed with a radical prostatectomy. On August 3, 1988, a radical prostatectomy was performed. The cancer was removed from A.C.'s prostate. According to the pathology report there was no indication that the cancer had spread beyond the surgical capsule of the prostate. With respect to the "labeling" of Mr. C.'s adenocarcinoma, the description "stage B" appears throughout Dr. Hilwa's notes and transcriptions in the hospital records. (See, for example Pet. Ex. #8, pages 195, 204, 210 & 260). DPR's Expert Testimony Dr. Richard H. Lewis is a physician practicing in Jacksonville who specializes in urology. He is Board certified. At DPR's request, Dr. Lewis examined medical records concerning Dr. Hilwa's case and predicated his opinions on portions of Dr. Hilwa's records. Dr. Lewis opined that a transurethral resection of the prostate ("TURP") is not an adequate method of evaluating a patient for prostate cancer; that a biopsy of the prostate, either through a transrectal or transperineal approach is the appropriate standard of care for evaluating or ruling out this particular diagnosis. Such biopsies are performed " . . . by guiding the needle to the area that you are concerned about so that you can actually feel the nodule and the needle and so you can be sure the needle is entering the area that you are concerned about." (Pet. Ex. #13, pages 10-11). Dr. Lewis stated that the key issue is that Dr. Hilwa did not "aggressively seek" to prove whether the patient did or did not have prostate cancer. (Pet. Ex. #13, page 16). Dr. Lewis further testified that about 50% of the time when you are biopsying a nodule you are going to miss it. He further conceded that a stone in the prostate is relatively common and if the physician is comfortable that he felt a stone he would be justified in not doing a biopsy. Dr. Lewis agreed that it was reasonable for Dr. Hilwa to not order the acid phosphatase and prostatic specific antigen tests in 1985. It would not be appropriate to draw those tests until a diagnosis of prostate cancer had been made. Dr. Lewis agreed that in this case the available evidence suggests that the patient had no spread of the prostate cancer outside the prostate and that a radical prostatectomy was an appropriate treatment option. Dr. Lewis believes Dr. Hilwa's records are logical and appropriate in terms of his thought patterns once the diagnosis of cancer was made. He conceded that records is an area where he may be "a little confused." "The medical record is there to document what was done so that you can look back at it in retrospect." His criticism of Dr. Hilwa's records was: So to me where he fell below the standard of care is that he didn't do what needed to be done. His records did not explain why he did that. (Pet. Ex. #13, pages 40-41) This conflicts with his opinion in his earlier written report of May 9, 1990, which stated: The physician does state the reasons for his treatment and course of actions in the records. (Attached Exhibit 2 to Pet. Ex. #13, page 4). Dr. Lewis believed that there was a "discrete nodule" in 1985. It was his further assumption that the "nodule" palpated in 1988 was the same "nodule" palpated in 1985. Such assumptions are inconsistent with the facts proven in this case. Dr. Lewis did not hear the final testimony of Dr. B-C wherein he stated that he did not palpate a nodule in or on Mr. C.'s prostate in 1986. He also did not hear the final hearing testimony of Dr. Hilwa describing what he, the clinician actually performing the evaluation, perceived. Dr. Lewis conceded that the practice of medicine is not a precise science; that there is room for clinical judgment based upon a physician's experience in his field; and that how a physician documents matters in a medical record may vary from physician to physician. Dr. Wajsman's Expert Testimony Dr. Zev Wajsman is a Professor of Surgery in the Division of Urology, and Chief of Urologic Oncology, at the University of Florida, College of Medicine, University of Florida, Gainesville, Florida. Dr. Wajsman is Board certified in urology and licensed in Florida and New York. He has published more than 112 articles in his field and gives presentations and lectures on an ongoing basis. In preparation for giving testimony for Dr. Hilwa in this case, Dr. Wajsman reviewed all medical records of Mr. C. pertaining to Dr. Hilwa's treatment of him in 1985 and 1988. In addition, he reviewed the depositions taken in this case, the transcript of the final hearing, and Dr. B-C's office records. Dr. Wajsman opined that Dr. Hilwa did not fall below the accepted standard of care in his care and treatment of Mr. C. in 1985 and 1988. He further testified that no acts or failures to act by Dr. Hilwa in treating Mr. C. caused any injury to him. Dr. Wajsman testified that on the basis of all the information he reviewed, there is no evidence that the patient had clinical evidence of prostate cancer in 1985. He found no evidence in the charts to suggest that Dr. Hilwa should have done a biopsy at the time. Many patients are referred to urologists as experts because of abnormal prostatic findings. A biopsy will not be done just because someone else believed that he felt an abnormal prostate. Quite often, in Dr. Wajsman's experience, his response to the referring physician will be that he didn't find or feel any abnormality. He consequently does not feel that he "has to do" a biopsy. It is Dr. Wajsman's understanding that the reason Dr. Hilwa did not do a biopsy was because in his clinical judgment there was no suspicious finding to perform a biopsy upon. So based on this finding and the fact that on the subsequent transurethral resection the specimen did not contain any cancer, Dr. Wajsman believed that there was no evidence of cancer at that time and therefore there was no substandard care by Dr. Hilwa. Dr. Wajsman believes the testimony of Dr. B-C describing an examination that he performed one year later on Mr. C. (1986) was significant in that he did not palpate a nodule at that time. In '85 this Dr. B-C referred this patient to Dr. Hilwa because of abnormal rectal findings. Then a year later, after TUR was done the same physician did not find any abnormality. So the question is what happened during this year, and the only explanation I can find out is that at the time of surgery, I mean transurethral resection, stones were removed from the prostate during the section, and it is possible that what the Dr. B-C felt the year prior to is that he felt a stone or hardened tissue around the stone which disappeared after transurethral resection. That enforced the reason Dr. Hilwa didn't do a biopsy because what he felt probably at the time, the referring physician felt was an abnormality not cause by cancer but by a stone or inflammatory reaction or whatever. (Resp. Ex. #1, page 12). Dr. Wajsman further opined that the records do not reveal that Dr. Hilwa in any fashion acted in bad faith or without due regard for the prevailing standard of care in treating Mr. C. Dr. Wajsman is unaware in the context of 1985 or even today of any requirement in the field of urology for a clinician in documenting a medical record to record a "degree of difficulty urinating," for example, 10 degrees or 50 percent or some fixed number, in order to conform to the standard of care. The notes described in paragraph 9, above, adequately document the difficulty. With respect to DPR's allegations that Dr. Hilwa should have performed prostatic specific antigen and acid phosphatase tests in 1985, Dr. Wajsman confirmed that the prostatic specific antigen test was not available on the market in a majority of places in 1985. The acid phosphatase test was available, but is done for patients who actually have prostate cancer. It was not necessary in 1985 or 1988. 1/ By not performing the two tests, no damage was done to the patient and such did not affect the ultimate treatment for this patient. With respect to the radical prostatectomy performed by Dr. Hilwa, it was done properly, and it successfully removed the cancer. The patient became incontinent, a very unfortunate, but accepted and known risk of complication with this type of surgery. With respect to DPR's allegations concerning the adequacy of Dr. Hilwa's records, Dr. Wajsman testified that while the records could be better, he believes that anyone's records can be better. He does not believe that Dr. Hilwa's records fall below the standard of care. The records do properly document why a biopsy was not done in 1985, and they do properly refer to the cancer as level B, which according to Dr. Wajsman, is a nodule or abnormality, confined to one lobe, usually less than 1 1/2 centimeters.
Recommendation Based on the foregoing, it is hereby, RECOMMENDED That the Department of Professional Regulation, Board of Medicine, enter its Final Order dismissing the Amended Administrative Complaint against the Respondent. DONE AND RECOMMENDED this 2nd day of May, 1991, in Tallahassee, Leon County, Florida. MARY CLARK Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904)488-9675 Filed with the Clerk of the Division of Administrative Hearings this 2nd day of May, 1991.
