The Issue Whether Respondent, a licensed physician, violated the applicable standard of care by diagnosing prostate cancer in four patients, and recommending and participating in a course of treatment for these patients, without confirming prostate cancer through tissue biopsy results; and, if so, what is the appropriate penalty?
Findings Of Fact Petitioner is responsible for the investigation and prosecution of complaints against medical doctors licensed in the state of Florida, who are accused of violating chapters 456 and 458 of the Florida Statutes. Respondent is licensed as a medical doctor in Florida, having been issued license number ME 46625. Respondent is not board-certified in any specialty recognized by the Florida Board of Medicine. Respondent has never had disciplinary action against his license to practice medicine. Respondent's Practice Since his residency concluded in 1985, Respondent has practiced urology. For more than 20 years, the focus of his practice has been prostate disease, its diagnosis, and treatment. In 2006, Respondent became the lead investigator for a General Electric study regarding its 3-Tesla magnetic resonance spectroscopy imaging machine (3T MRI-s) as part of an Institutional Review Board measuring the heat generated by the machine to ensure the safety of patients. Between 2006 and 2010, 1,600 prostates were scanned with a 3T MRI-s as part of the study. Respondent reviewed the results of each radiology report associated with these scans and compared them to the clinical data he had for each patient. Respondent also completed a double-blind study of 200 of these patients who had prostate biopsies during 2008 and 2009, as well as the 3T MRI-s, correlated the results of the biopsies and the scans, and became convinced that the 3T MRI-s technology alone is a positive predictor of prostate cancer 95 percent of the time. According to both parties' experts, as well as Respondent, the standard of care in Florida and throughout the United States is to use a needle tissue biopsy to identify prostate cancer. As admitted by Respondent, medical schools teach that needle biopsy is "the way" to diagnose prostate cancer. Absent a biopsy showing malignant tissue, it is not possible for a reasonably prudent physician to diagnose or treat prostate cancer. Biopsies are usually performed to diagnose prostate cancer if a man has a combination of risk factors, such as family history, an abnormal digital rectal exam, and/or increasing levels of Prostate Specific Antigen (PSA). However, needle biopsies for prostate cancer carry a false negative rate of 20 to 50 percent, which means that a standard 12-point needle biopsy (where 12 samples of tissue from different locations in the prostate are sampled) often misses cancerous tissue. Prostate needle biopsies are sometimes painful and carry a risk of complications, including common complications such as bleeding and infection, and the unlikely complications of septic shock and death. Respondent is convinced that there is a significant risk from a prostate needle biopsy to spread prostate cancer cells outside the prostate capsule, which is referred to as "seeding" or "needle tracking." Respondent's belief is founded upon a one-page 2002 article published in the American Urological Association, Inc.'s Journal of Urology (Journal), which refers to two cases in which a tumor was discovered in the rectal wall after prostate biopsies and cryoblation.1/ The tumors were suspected of being the result of needle tracking from prostate cancer biopsies. Significantly, this article makes clear that needle tracking resulting from prostate biopsies are rare and "exceedingly uncommon." Respondent's concern, regarding prostate biopsies spreading prostate cancer, is also in part founded upon a one-paragraph 1991 Journal abstract reporting a Johns Hopkins University School of Medicine study of 350 patients in which needle tracking was suspected in seven patients (two percent).2/ According to Respondent, his belief that prostate biopsies spread prostate cancer is "intuitive," although he acknowledges this is not the prevailing view in Florida. Respondent argues that doctors do not want to believe needle tracking takes place with prostate biopsies and suggests there is a financial motivation for doctors to require a positive biopsy before definitively diagnosing prostate cancer. Respondent is so convinced of the dangers of needle biopsies for prostate cancer that he published a book, Men at Risk: the Dirty Little Secret – Prostate Biopsies Really Do Spread Prostate Cancer Cells, in 2012, which he provides to all his patients. In his book, Respondent states: For me, a 3T MRI scan is the best objective marker to a diagnosis of prostate cancer. To summarize, patients must answer one question. Should I agree to a prostate biopsy procedure where it has been proven to spread prostate cancer cells or do I keep my fingers and toes crossed, hoping for the best? In two words, . . . "absolutely not." To me, the decision is easy – the literature validates avoiding random biopsies and supports imaging with a 3 T magnet. There is no other organ in the human body where diagnosis is dependent on sticking needles randomly and blindly into a delicate organ in an attempt to find cancer. This practice is archaic, patently barbaric, unacceptable and preferentially favored by virtually all urologists. Beyond the obvious benefit to being able to see a cancer and its pattern of invasion with the 3.0 Tesla MRI scan, there is no other exam or scan that competes in terms of diagnostic accuracy or predictability. The discerning patient will soon recognize that guessing where cancer is located, through random biopsies, is for the less informed.[3] Respondent refers to the use of 3T MRI-s as the "truth serum" of prostate cancer diagnosis. During all times material hereto, Respondent held himself out as a urologist who could diagnose and treat prostate cancer without a needle biopsy. In fact, the four patients at issue in this case found Respondent through an Internet search. Respondent defines his office, the Diagnostic Center for Disease (DCD) as, "A comprehensive prostate cancer diagnostic center in Sarasota, Florida specializing in non-invasive diagnostics (MRI/MRIS) without biopsy as an integral part of the diagnostic evaluation of prostate cancer."4/ Respondent also advertised himself as "a world expert in High Intensity Focused Ultrasound (HIFU), having diagnosed and treated more patients for prostate cancer from more countries than any other treating doctor in the world."5/ HIFU is a treatment alternative to brachytherapy (the insertion of radioactive seeds into the prostate), radiation, and prostatectomy (the surgical removal of the prostate gland) for prostate cancer and uses highly focused ultrasound waves in a small area to create intense heat, which destroys prostate cancer tissue. HIFU was not an approved treatment for prostate cancer in the United States until October 9, 2015, at which time the Food and Drug Administration (FDA) approved the use of the Sonablate machine for prostate tissue ablation. Prior to that time, Respondent referred his patients to treatment facilities in Mexico and the Caribbean where he performed HIFU treatments. The standard of care in Florida precludes treating prostate cancer with HIFU in the absence of a tissue biopsy confirming the presence of cancer. In order to be eligible for HIFU treatment, in addition to a positive diagnosis, the patient's prostate gland must be less than 40 grams. HIFU is not appropriate on patients with multiple calcifications in their prostate because they interfere with the treatment. Because a smaller prostate gland is easier to work with, prior to undergoing HIFU treatment, patients are often prescribed Bicalutamide (also known by its brand name, Casodex) and Trelstar. Bicalutamide suppresses the uptake of testosterone and Trelstar suppresses the production of testosterone, with both drugs having the effect of shrinking the prostate gland. Side effects of these drugs include hot flashes, weakness, and a sense of a loss of well-being. Facts Related to Patient G.P. Patient G.P., a 69 year-old retiree, had a prostate biopsy performed in December 2005 after a rise in his PSA level. This biopsy was negative for prostate cancer, but Patient G.P. was diagnosed with an enlarged prostate and benign prostate hyperplasty (BPH). In May 2008, Patient G.P. learned through a physical exam for a life insurance policy that his PSA level was elevated. After another check of his PSA level in November 2008, Patient G.P. was advised to undergo another prostate biopsy. Because his first prostate biopsy was painful, Patient G.P. searched the Internet for alternatives to biopsy and learned of Respondent and his use of the 3T MRI-s at the DCD in Sarasota for diagnosing prostate cancer. Patient G.P. traveled to Florida from Michigan to meet with Respondent on January 5, 2009. Patient G.P. underwent a 3T MRI-s scan at Respondent's office. Respondent told Patient G.P. that he was unsure of the results because they were consistent with BPH and not prostate cancer. However, Respondent advised Patient G.P. was considered "high risk" because his father died from prostate cancer in 2002. Rather than undergoing any treatment at that time, Patient G.P. was prescribed Avodart for his BPH and agreed to active surveillance (A.S.) whereby he would receive regular PSA screening. When Patient G.P.'s December 2009 PSA level went up after being on Avodart for most of the year, he was concerned and telephoned Respondent's office. Respondent prescribed Casodex based upon his telephone call with Patient G.P. on January 15, 2010. By February 2010, G.P.'s PSA level decreased significantly, but not as much as he believed it should have after taking Casodex for several weeks. Patient G.P. also experienced urinary frequency problems and pain. He returned to Respondent's office where Respondent performed an ultrasound and digital rectal exam. Respondent told Patient G.P. it was likely he had prostate cancer, but that he could not be sure without a biopsy. However, Respondent's medical records reflect that Respondent diagnosed Patient G.P. as having prostate cancer without a tissue biopsy.6/ Respondent offered to do a targeted biopsy based on an MRI scan. Respondent also discussed his concerns regarding needle tracking from biopsies with Patient G.P. Patient G.P. made it clear he did not want a biopsy, and he wanted to proceed to HIFU. Respondent advised Patient G.P. of the risk of erectile dysfunction following HIFU, but did not discuss the possibility of urinary stricture problems. In April 2010, Patient G.P. traveled to Mexico where the HIFU procedure was performed by Respondent. In March 2011, Patient G.P. saw a urologist in Michigan about his diminished urinary stream and pain. The urologist used a reamer to open Patient G.P's urethra, but on April 15, 2011, he went to the emergency room because he was completely unable to urinate. Patient G.P. was catheterized and subsequently underwent electro-vaporization on April 25, 2011, to relieve the urinary stricture. In August 2011, Patient G.P. also underwent hydro- dilating in an attempt to relieve the symptoms of his urinary stricture. In September 2011, Patient G.P. saw board-certified urologist Dr. Joel Gelman, who specializes in urethral reconstruction. At that time, Patient G.P. was advised that his urinary stricture, caused by the HIFU treatment, was a significant problem because his urethra was closed off almost to the bladder neck. Dr. Gelman performed a transurethral resection of the prostate (TURP). As part of the TURP procedure, Dr. Gelman took samples of Patient G.P.'s prostate tissue and no evidence was found of prostate cancer. Although Patient G.P. had no complaints regarding his course of treatment from Respondent, Dr. Gelman filed a complaint against Respondent because he was concerned that Respondent prescribed medications and performed HIFU on Patient G.P. for prostate cancer without a tissue biopsy. Facts Related to Patient J.W. Patient J.W., a 74 year-old retired dentist, had two biopsies performed in 2005 and 2007 ordered by his urologist in Alabama in response to elevated PSA levels. No evidence of malignancy was found. Patient J.W.'s PSA level was again elevated when tested in March 2012. He was reluctant to have another biopsy because the first two were painful. Patient J.W. was told about Respondent by a friend, and he viewed Respondent's website. Patient J.W. was interested in consulting with Respondent because Respondent advertised he had an MRI machine that could detect cancer cells, and Respondent believed prostate biopsies spread cancer. Patient J.W. traveled from Alabama to meet with Respondent at the DCD on May 14 and 15, 2012. After a sonogram and MRI, Respondent diagnosed Patient J.W. with prostate cancer. Respondent discussed a treatment plan which included what Respondent called "chemical castration" for a period of six months, to be followed with a trip to Mexico for HIFU treatment at the cost of $32,000.00. Respondent did not suggest any other treatment options to Patient J.W. or recommend a tissue biopsy. The idea of "chemical castration" scared Patient J.W., who sought a second opinion in June 2012 from another urologist, Dr. M. Eric Brewer. Dr. Brewer told J.W. that HIFU was not an accepted treatment in the United States for prostate cancer. Patient J.W. declined to go forward with treatment by Respondent. Dr. Brewer recommended A.S. and, as recommended by Dr. Brewer, Patient J.W. has his PSA level checked every six months. Patient J.W.'s PSA levels have decreased without any treatment. Dr. Brewer discussed Patient J.W.'s case with his partners, the tumor board, the president of the Southeastern Urological Association, and the president of the American Board of Urology, who unanimously advised Dr. Brewer to file a complaint with Petitioner against Respondent for cancer diagnosis and recommending treatment in the absence of a pathologic specimen. Facts Related to Patient K.S. Patient K.S. is a 62-year-old video producer and editor from Tennessee. He has no family history of prostate cancer. Patient K.S. had his PSA level tested in 2005 and 2009, at which time it was considered elevated. Patient K.S. was referred to a urologist by his primary care physician. After again showing elevated PSA levels, Patient K.S. underwent a prostate biopsy in 2011 and 2012. Neither biopsy was positive for prostate cancer. However, Patient K.S. and his wife were concerned about his rising PSA level and sought a second opinion. Patient K.S.' wife was concerned that if her husband had prostate cancer, his local urologist would recommend removal of the prostate. She researched alternative treatments on the Internet and found Respondent's website. On October 15, 2012, Patient K.S. and his wife traveled to the DCD in Sarasota to meet with Respondent. Respondent initially performed an ultrasound on Patient K.S. and then told Patient K.S. he was "concerned" Patient K.S. had prostate cancer. He recommended HIFU treatment to Patient K.S. Respondent made it clear to Patient K.S. that Respondent would not perform a needle biopsy because it pushes cancer further into the prostate. Respondent told Patient K.S. that the MRI would make it clear whether Patient K.S. had prostate cancer. Later that same day, Patient K.S. had an MRI performed at the DCD. Approximately a week later, Patient K.S. received a telephone call from Respondent with the MRI results who told Patient K.S. that based on the MRI, he had Gleason 7 prostate cancer, a fairly aggressive form of prostate cancer that could be treated with HIFU in Mexico the following month. This was followed up with an e-mail from the DCD to Patient K.S. demanding a payment of $32,000.00 within three days to schedule the HIFU procedure in Mexico. Patient K.S.' wife immediately secured a bank loan for the $32,000.00 Due to the seriousness of the diagnosis and the rush for payment for HIFU, Patient K.S. visited his primary care doctor for another opinion. Patient K.S' primary care doctor, Dr. Jeffrey Jump, told him that no one can diagnose prostate cancer as a Gleason 7 without a tissue biopsy. Further, it was a "red flag" to Dr. Jump that a cash payment of $32,000.00 was expected in such a short time frame to schedule treatment. After speaking to Dr. Jump, Patient K.S. decided not to have HIFU and instead opted for A.S. Subsequent PSA level tests for Patient K.S. have shown a decrease in his PSA level. Patient K.S.' wife filed a complaint with the Petitioner against Respondent. Facts Related to Patient V.P. Patient V.P. is a 63-year-old construction worker and guide from Alaska. He has no family history of prostate cancer. In August 2013, at age 60, Patient V.P. had his first physical examination. As part of the exam, he took a PSA test, which showed an elevated PSA level of 6.3. As a result, Patient V.P. was referred to a urologist who recommended a biopsy. Patient V.P. heard from friends that prostate biopsies are painful, so he looked on the Internet for alternatives. Patient V.P. found Respondent's website, which claimed Respondent could diagnose prostate cancer without a biopsy by using new MRI technology. Patient V.P. traveled to Sarasota to meet Respondent on September 11, 2013. Respondent performed a digital rectal exam and told Patient V.P. that his prostate was much enlarged. Respondent next performed a prostate ultrasound on Patient V.P. Immediately after the ultrasound, Respondent told Patient V.P., "I'm telling you right now you have prostate cancer." Respondent provided Patient V.P. with a prescription for Bicalutamide and Trelstar, which Respondent said would wipe out Patient V.P.'s testosterone and slow the growth of the cancer. Respondent told Patient V.P. that prostate biopsies are dangerous and metastasize cancer cells. Respondent said that even though he knew Patient V.P. had cancer, he wanted an MRI to see the amount of cancer. Respondent also offered Patient V.P. the opportunity to participate in a private placement offering for a HIFU company he was forming for a minimum investment of $50,000.00. The following day, Patient V.P. had an MRI and then met with Respondent to review the results. Respondent showed Patient V.P. his MRI images and pointed to areas of concern. Respondent told Patient V.P. he had extensive prostate cancer and that Patient V.P. did not have much time to decide whether to have HIFU because the cancer was about to metastasize. Respondent told Patient V.P. to take the Bicalutamide for ten days and then return for an injection of Trelstar to atrophy his prostate and make him ready for HIFU in 90 days. At Respondent's direction, Patient V.P. began the Bicalutamide and then returned to the DCD on September 20, 2013, for a three-month injection of Trelstar. During this visit, Patient V.P. questioned the cost if the HIFU was not successful in getting all the cancer and he needed further treatment. Respondent told Patient V.P. that he "doesn't miss," but an additional treatment of HIFU would cost another $10,000.00 to $12,000.00, in addition to the $32,000.00 for the initial treatment. Concerned about these costs, Patient V.P. asked about going to Loma Linda, California, for proton therapy as an alternative. Respondent told Patient V.P. that proton therapy would cause bladder cancer and any alternative to HIFU would require a needle biopsy first. Respondent actively discouraged Patient V.P. from any non-HIFU treatment for prostate cancer. As soon as Patient V.P. questioned Respondent about alternatives to HIFU, he was suddenly fast-tracked for HIFU scheduled October 24 through 26, 2013. He was told he needed to make a $10,000.00 deposit to hold the date and the total cost was $32,000.00. Despite his concerns regarding the expedited scheduling of his procedure and the cost of the HIFU treatment, Patient V.P. returned to the office with a check for $10,000.00 to cover the cost of the deposit to hold the October treatment date. While waiting to hand the check to Respondent's receptionist, Patient V.P. overheard Respondent on a speakerphone arguing with a radiologist concerning an MRI report. Respondent was insisting the radiologist include the word "cancer" on MRI reports and the radiologist insisted it was not possible for him to make such a diagnosis. After hearing this conversation, Patient V.P. immediately left Respondent's office with his check. Patient V.P. subsequently discussed his experience with a trusted friend who practiced as a nurse in a cancer clinic. She, too, expressed concerns about diagnosing and treating prostate cancer without a biopsy. Patient V.P. was referred by this friend to Dr. Vipul Patel, a physician specializing in urologic cancer in Orlando. Patient V.P. met with Dr. Patel on October 18, 2013. Dr. Patel advised Patient V.P. that it was not possible to diagnose prostate cancer without a biopsy. Dr. Patel also disputed that prostate biopsies can spread prostate cancer. Dr. Patel performed a digital rectal exam and found Patient V.P.'s prostate to be slightly enlarged (which is not abnormal for a man of Patient V.P.'s age), normal, and smooth. Dr. Patel told Patient V.P. that he doubted he had prostate cancer. Patient V.P. then underwent a prostate biopsy by Dr. Patel, which was negative for prostate cancer. This was surprising to Patient V.P. because Respondent led him to believe, based on the MRI, that his prostate was full of cancer. Patient V.P. experienced significant side effects as a result of taking the medications ordered by Respondent. The Bicalutamide caused Patient V.P. to experience overwhelming depression, shakes, hot flashes, tunnel vision, and headaches. The Trelstar caused erectile dysfunction, increased frequency of hot flashes, night sweats, and made Patient V.P. so weak he was unable to work for eight months. Standard of Care As discussed above, the experts who provided depositions or live testimony in this case were unanimous in their conclusions that the standard of care in Florida from 2008 through 2013 precluded diagnosis or treatment of prostate cancer in the absence of a tissue biopsy. A reasonably prudent physician would not tell a patient he had prostate cancer based upon an ultrasound and/or MRI. A reasonably prudent physician would not prescribe medication, suggest treatment, or participate in treating a patient for prostate cancer, based upon an ultrasound or MRI. Respondent claims that in each of these cases, he advised the patient that a needle biopsy was the definitive test for prostate cancer, but it was a method he did not favor due to the possibility of needle tracking. Respondent's testimony in this regard is not credible in light of the credible testimony of the three patients that Respondent made clear he would not perform a needle biopsy and actively discouraged them from anything other than diagnosis by MRI and subsequent HIFU treatment. Respondent's suggestion, that he offered needle biopsy as an option, is wholly inconsistent with the title, theme, and contents of his own book, and the manner in which he defined his method of diagnosing prostate cancer at the DCD in his book and on his website. It is self-evident that a patient's perceptions regarding the safety and efficacy of needle biopsies for prostate cancer detection are at least, in part, influenced by the discussion with the physician. Respondent's active efforts to dissuade these patients from having the one definitive test for prostate cancer, by dramatically over-inflating the infinitesimally small possibility of needle tracking, were wholly inconsistent with the standard of care. Respondent claims that these four patients insisted they did not want a needle biopsy, therefore, it was appropriate to diagnose them on the basis of "a preponderance of the evidence and concordance of data" and move forward with a treatment plan, including medications and HIFU. The standard of care in Florida during 2008 through 2013, for a situation in which a patient suspected of having prostate cancer refused a needle biopsy, was to prescribe a course of A.S., including regular and frequent PSA testing, and to offer no other treatment.7/ Ultimate Factual Determinations Petitioner established by clear and convincing evidence that Respondent committed medical malpractice in his treatment of Patients G.P., J.W., K.S., and V.P. by the following violations of the standard of care: failing to obtain and review prostate biopsy results before confirming the patient had, or diagnosing the patient with, prostate cancer (Patients G.P., J.W., K.S., and V.P.); prescribing Bicalutamide/Casodex to a patient without first confirming through a prostate tissue biopsy that the patient has prostate cancer (Patients G.P. and V.P); prescribing, injecting, or authorizing the injection of Trelstar to a patient without first confirming through biopsy results that the patient has prostate cancer (Patient V.P); recommending and/or attempting to facilitate HIFU treatment without first confirming through biopsy results that the patient has prostate cancer (Patients G.P., J.W., K.S., and V.P.); and participating in, and/or assisting with the performance of HIFU treatment for a patient without first confirming through biopsy results that the patient has prostate cancer (Patient G.P.). Accordingly, Respondent is guilty of the offense defined in section 458.331(1)(t), Florida Statutes.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding that Respondent violated section 458.331(1)(t), Florida Statutes, as charged in Amended Administrative Complaints; imposing a fine of $30,000.00; revoking Respondent's medical license; and imposing costs of the investigation and prosecution of this case. DONE AND ENTERED this 24th day of February, 2017, in Tallahassee, Leon County, Florida. S MARY LI CREASY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 24th day of February, 2017.
The Issue 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 The issue for determination is whether respondent committed the offenses set forth in the administrative complaint and, if so, what action should be taken.
Findings Of Fact Craig William Herman, M.D. (Respondent) is, and has been at all times material hereto, a licensed physician in the State of Florida, having been issued license number ME0043959. Respondent has been licensed in Florida since 1984. Respondent is Board certified in urology. On March 27, 1992, Patient E. G., a forty-five year old male, presented to Respondent for a male fertility evaluation. When a patient presents for an infertility evaluation, it is appropriate for a urologist to obtain a urologic history and to evaluate urologic problems. Patient E.G.'s history was consistent with his chief complaint of infertility. His history includes that, during his seven years of marriage to his first wife no children were conceived even though no contraceptives were used and that, after remarrying, Patient E.G.'s second wife was not able to conceive even though she had a child from her previous marriage. Respondent's further evaluation of Patient E.G. on March 27, 1992, revealed that Patient E.G. suffered from urinary hesitancy and nocturia two to four times per night. The nocturia and urinary hesitancy are symptoms of an outlet obstruction. Additionally, on March 27, 1992, Respondent performed a physical examination including a digital rectal examination. The examination revealed, among other things, that Patient E.G. had a firm 2+ prostate and bilateral varicoceles. A firm 2+ prostate indicates an enlarged and suspicious prostate. Respondent also performed various tests on this first visit. He took a urine culture and performed a urinalysis, a bladder ultrasound scan (echography) and a prostate ultrasound scan (transrectal ultrasound). Respondent had a concern for possible prostate infection and outlet obstruction. The bladder ultrasound, which is a non-invasive procedure, was performed to address this concern and was medically indicated. Because of the abnormality of the prostate, the prostate ultrasound was performed to evaluate the prostate and was medically indicated. The prostate ultrasound or transrectal ultrasound of the prostate revealed a hypoechoic region of the prostate. Such a result was positive and Respondent interpreted it as suggestive of a lesion or carcinoma of the prostate. Patient E.G.'s urine culture, urinalysis, and bladder ultrasound scan produced normal results. Included as a procedure on this first visit was a semen analysis. Respondent sent Patient E.G. to Holy Cross Hospital for the analysis. The results of the analysis, which were received on March 30, 1992, reported a low sperm count and low motility. On April 3, 1992, Patient E.G. returned to Respondent for a follow-up appointment. On this second visit, Respondent performed or ordered several tests on Patient E.G.: repeat urinalysis, repeat urine culture, repeat prostate ultrasound, a prostate biopsy, renal and scrotal ultrasound, SMAC-25, free testosterone, prolactin, prostate specific antigen (PSA) blood test, and uroflometry. The prostate biopsy was medically indicated due to Patient E.G.'s firm prostate discovered during the digital rectal examination and due to the observation of the hypoechoic region. Respondent performed the biopsy, using the transrectal prostate ultrasound as guidance. The biopsy revealed an abnormal, benign growth known as hyperplasia. As Patient E.G.'s transrectal biopsy procedure was performed in Respondent's office, Respondent was not required to prepare a biopsy operative report. A copy of the pathology report for the biopsy procedure was in Respondent's medical records for Patient E.G. The scrotal ultrasound, as an evaluative procedure for a fertility patient, was medically indicated. The ultrasound was used as an objective procedure to review Patient E.G.'s bilateral varicoceles. The hormonal tests, consisting of testosterone and prolactin, were medically indicated as part of the fertility evaluation. An evaluation of Patient E.G.'s hesitancy was medically indicated, using the uroflometry as the evaluative procedure. The results were abnormal which suggested obstructive uropathy or bladder outlet syndrome. Because of Patient E.G.'s abnormal uroflow results and enlarged prostate, Respondent determined that Patient E.G.'s upper and lower urologic tract should be examined. The renal ultrasound was medically indicated to assist in determining whether an obstruction existed within the upper urologic tract. The results from the renal ultrasound revealed a suspicious cyst or mass in Patient E.G.'s left kidney. A follow-up ultrasound on the left kidney was medically indicated. The second ultrasound was performed on April 13, 1992. The results of all the remaining tests were within normal limits. Subsequently, on April 13, 1992, Patient E.G. returned to Respondent for another follow-up appointment. On this third visit, Respondent performed the following procedures: repeat urinalysis, repeat urine culture, and repeat ultrasound scan of the left renal unit (kidney). Bilateral renal ultrasounds are more common than an ultrasound of only the left kidney. However, no cost evidence was presented regarding the cost of a bilateral ultrasound versus a unilateral renal ultrasound. Patient E.G.'s ultrasound scans and tests performed on April 13, 1992, all produced normal results. All of the ultrasound examinations, except for one renal examination, conducted during Patient E.G.'s three visits were performed in Respondent's office. On all three visits, Respondent ordered Patient E.G.'s urine to be tested. The tests consisted of a urinalysis, culture, and sensitivity which are diagnostics procedures used to detect infection. If there is a concern about an infection, it is medically indicated to order these tests during each visit. Respondent had a concern regarding infection on each office visit. Patient E.G.'s infertility, his exhibited urologic symptomatology and his low semen volume are indicators of infection. Furthermore, after the biopsy, which is an invasive procedure, testing is appropriate to determine the presence of an infection. The urinalysis, culture and sensitivity were all medically indicated tests for each of Patient E.G.'s visits. Respondent's medical records included the specific laboratory results of each test which was performed on Patient E.G. As to the ultrasounds, Respondent is not required to prepare an independent written evaluation of an ultrasound film when the films are present in the chart unless a formal reading is requested. The ultrasound films were present in the chart, and no formal reading of the films was requested. Respondent practiced medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar Board certified urologist as being acceptable under similar conditions and circumstances. Respondent's medical records justify the course of treatment of Patient E.G. Respondent did not exploit Patient E.G. for financial gain.
Recommendation Based on the foregoing Findings of Fact and Conclusions of law, it is RECOMMENDED that the Board of Medicine dismiss Counts One, Two and Three of the administrative complaint. DONE AND ENTERED this 5th day of April, 1996, in Tallahassee, Leon County, Florida. ERROL H. POWELL, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 5th day of April, 1996. APPENDIX The following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact Partially accepted in finding of fact 1. Partially accepted in finding of fact 2. Partially accepted in finding of fact 3. Partially accepted in finding of fact 3. Partially accepted in finding of fact 5. Partially accepted in finding of fact 9. Partially accepted in finding of fact 13. Partially accepted in finding of fact 12. Partially accepted in finding of fact 14. Partially accepted in finding of fact 14. Partially accepted in finding of fact 15. Partially accepted in finding of fact 15. Partially accepted in finding of fact 17. Partially accepted in finding of fact 25. Partially accepted in finding of fact 25. Partially accepted in finding of fact 27. Rejected as being argument, or a conclusion of law. Partially accepted in finding of fact 3. Rejected as being contrary to the greater weight of the evidence. Partially accepted in finding of fact 7. Partially accepted in findings of fact 7, 13, and 24. Partially accepted in findings of fact 15 and 24. Partially accepted in findings of fact 7 and 8. Rejected as being contrary to the greater weight of the evidence. Rejected as being contrary to the greater weight of the evidence. Rejected as being contrary to the greater weight of the evidence. Partially accepted in finding of fact 28. Rejected as being contrary to the greater weight of the evidence. Rejected as being contrary to the greater weight of the evidence. Rejected as being contrary to the greater weight of the evidence. Respondent's Proposed Findings of Fact Partially accepted in finding of fact 1. Partially accepted in finding of fact 2. Rejected as being unnecessary, argument, or conclusion of law. Rejected as being unnecessary, argument, or conclusion of law. Rejected as being unnecessary, argument, or a conclusion of law. Rejected as being unnecessary, argument, or a conclusion of law. Rejected as being unnecessary, argument, or a conclusion of law. Partially accepted in finding of fact 3. Partially accepted in finding of fact 4. Partially accepted in finding of fact 5. Partially accepted in finding of fact 7. Partially accepted in finding of fact 8. Partially accepted in findings of fact 6, 8, 10 and 11. Partially accepted in finding of fact 6. Partially accepted in findings of fact 6, 9 and 10. Partially accepted in finding of fact 10. Partially accepted in findings of fact 9 and 11. Rejected as being unnecessary, argument, or a conclusion of law. Rejected as being unnecessary, argument, or a conclusion of law. Partially accepted in finding of fact 12. Rejected as being unnecessary, argument, or a conclusion of law. Partially accepted in findings of fact 15 and 16. Rejected as being unnecessary, argument, or a conclusion of law. Partially accepted in finding of fact 16. Partially accepted in finding of facts 12 and 17. Partially accepted in finding of facts 15 and 19. Partially accepted in finding of fact 19. Partially accepted in findings of fact 15 and 20. Partially accepted in findings of fact 15 and 21. Partially accepted in finding of fact 22. Rejected as being unnecessary, argument, or a conclusion of law. Partially accepted in findings of fact 15 and 22. Partially accepted in finding of fact 23. Partially accepted in finding of fact 26. Partially accepted in finding of fact 29. Partially accepted in finding of fact 29. Partially accepted in finding of fact 30. Partially accepted in finding of fact 30. Rejected as being unnecessary, argument, or a conclusion of law. Partially accepted in finding of fact 34. Partially accepted in finding of fact 34. Partially accepted in findings of fact 10, 11, 16, 20, 21, 22, 23, 29, 30, and 34. Rejected as being unnecessary, argument, or a conclusion of law. Partially accepted in finding of fact 32. Partially accepted in finding of fact 33. Partially accepted in finding of fact 31. Partially accepted in finding of fact 18. Partially accepted in finding of fact 33. NOTE: Where a proposed finding has been partially accepted, the remainder has been rejected as being irrelevant, unnecessary, cumulative, contrary to the greater weight of the evidence, argument, or a conclusion of law. COPIES FURNISHED: Hugh R. Brown Staff Attorney Agency for Health Care Administration, Board of Medicine 1940 N. Monroe Street, Suite 60 Tallahassee, Florida 32399-0792 Mark A. Dresnick, Esquire Grand Bay Plaza, Suite 201 2665 South Bayshore Drive Miami, Florida 33130 Jerome W. Hoffman, General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32309 Sam Power, Agency Clerk Agency for Health Care Administration Fort Knox Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308
Findings Of Fact Based upon the evidence adduced at hearing, and the record as a whole, the following Findings of Fact are made: The Agency is a state government licensing and regulatory agency. Respondent is now, and has been since 1969, a physician licensed to practice medicine in the State of Florida. He holds license number ME 0014277. This is the first time that Respondent has faced formal charges of professional misconduct in the 25 years he has been licensed to practice medicine in the State of Florida. On or about April 14, 1992, patient E.L., a 62-year old female, presented to Respondent at Respondent's office in Coral Gables, Florida, with complaints of swelling and pain in her right leg that she had been experiencing since a cardiac catherization performed a few months previous. E.L. walked with a noticeable limp. An examination of her right leg revealed redness and severe swelling. E.L. reported pain upon palpation of the Hunter's canal, tibial posterior vein and popliteal cord of the leg. These findings, however, were not documented by Respondent. Based upon his observations, and without the benefit of any objective diagnostic studies, Respondent diagnosed Respondent's condition as thrombophlebitis, 3/ which is the inflammation of either a superficial or deep vein associated with blood clot formation. Thrombophlebitis involving the deep venous system is referred to as deep vein thrombosis or DVT. DVT is a potentially life threatening condition which requires immediate medical attention. Appropriate treatment for thrombophlebitis includes the use of anticoagulants, including the legend drugs Coumadin and Heparin. A patient treated with anticoagulants is exposed to the risk of internal bleeding, which could lead to the patient's death. Given what Respondent had observed during E.L.'s visit to his office that day, his clinical diagnosis of thrombophlebitis was not an unreasonable one, notwithstanding that Respondent's written record of the visit, because it is inaccurate in part as well as incomplete, does not contain information sufficient to support such a clinical diagnosis. A diagnosis of thrombophlebitis based solely upon clinical findings, however, is more likely than not to be inaccurate because of the various other conditions that mimic thrombophlebitis in terms of symptomatology. Confirmatory testing is therefore necessary to supplement these clinical findings. The most reliable test available in April of 1992, for diagnosing thrombophlebitis was the venogram, an invasive diagnostic procedure in which the patient's veins are injected with an iodine dye and then x-rayed. The next most reliable test was the venous duplex imaging scan, a non- invasive test involving ultrasonography, which, studies have shown, is 94 percent accurate with 3 percent false positives and 3 percent false negatives. Other non-invasive confirmatory tests that were available at the time included the continuous doppler and plethysmography. After having clinically evaluated E.L., Respondent made the necessary arrangements to have her admitted to Coral Gables Hospital (hereinafter referred to as "CGH"), located across the street from his office, where he had privileges. 4/ Before doing so, he did not have E.L. undergo any tests to confirm his clinical diagnosis of thrombophlebitis. E.L. was admitted to CGH at around 8:30 p.m. on April 14, 1994, with an "admission diagnosis" of "thrombophlebitis of the right lower extremity." The typewritten "admission note" which Respondent signed as the admitting physician inaccurately reflects that the results of E.L.'s physical examination were essentially normal. This "admission note" was dictated and prepared by someone other than Respondent. Respondent signed the note on or about May 6, 1992, without carefully reading it. E.L. remained hospitalized for a week. Throughout E.L.'s hospitalization Respondent was her treating physician. During E.L.'s stay in the hospital, Respondent consulted with a pulmonologist, neurologist and cardiologist to obtain assistance in the care and treatment of E.L. Neither the pulmonologist, neurologist nor cardiologist agreed with Respondent's assessment of E.L.'s condition. The pulmonologist was the first of these specialists to be consulted. He was called in because of the rales and wheezes Respondent heard when he examined E.L. In his consultation report, the pulmonologist described the results of his examination of E.L.'s extremities as follows: Obese, but symmetric. There is no increase in warmth or discoloration of the skin on either lower extremity. Homans' sign is negative bilaterally. We cannot find any palpable venous cords in either leg. The peripheral pulses are 2 Plus in the dorsalis pedis and tibialis posterior distribution. The range of motion is preserved in both lower extremities. There are no hematomas over either groin. Small puncture sites are seen at the site of prior cardiac catherization. In a subsequent portion of his report, the pulmonologist gave the following assessment of E.L.'s "problem," an opinion that was essentially shared by the other two consulting specialists: This is a patient with an unclear cardiac history, but apparently is severe enough to require cardiac catherization in the past, 5/ who now comes in with right leg pain. Our clinical impression is that this pain is probably neuropathic in origin and related to an attempted cardiac catherization on the right femoral artery with damage to the femoral nerve bundle on the right leg. 6/ At the present time, we find no historical or clinical evidence to suggest deep venous thrombosis in this patient who is usually active. Accordingly, the pulmonologist made the following recommendations: At the present time, we would hold anticoagulants on this patient until a definite diagnosis can be made of her regarding the patency of the venous system in the right lower extremity. The goal standard at this time would appear to be a right leg venogram, which would clear all doubts regarding this problem. Respondent declined to follow the pulmonologist's recommendation that a venogram be performed because it appeared from Respondent's review of E.L.'s medical records that she was allergic to the iodine dye used in the venogram. The pulmonologist therefore ordered a venous duplex imaging scan for E.L. The scan was performed on April 16, 1992. Alan Fishman, M.D. issued the following written report on the scan and its results: DATE 4-16-92 VENOUS DUPLEX IMAGING OF RIGHT LOWER EXTREMITY: ULTRASOUND IMAGING OF THE COMMON FEMORAL, SUPERFICIAL FEMORAL, POPLITEAL, AND SAPHENOUS VEINS WERE PERFORMED. THESE VEINS REVEALED NO EVIDENCE OF ABNORMAL INTERNAL ECHOGENICITY. ALL SAMPLED VESSELS DEMONSTRATED NORMAL COMPRESSIBILITY. NO ABNORMALITIES WERE DEMON- STRATED ON THE DOPPLER SIGNAL ANALYSIS PERFORMED. IMPRESSION: VENOUS DUPLEX IMAGING OF THE RIGHT LOWER EXTREMITY FAILED TO REVEAL EVIDENCE OF DEEP VENOUS THROMBOSIS WITHIN THE SAMPLED VESSELS. Notwithstanding the foregoing, Respondent treated E.L. with the anticoagulants Coumadin and Heparin because, in his mind, the possibility still existed that E.L. had DVT. E.L. was discharged from the hospital on April 21, 1992. The typewritten "discharge summary" which Respondent signed as E.L.'s treating physician, like the "admission note" he also signed, was dictated and prepared by someone other than Respondent. Respondent signed the "discharge summary" on or about May 6, 1992. He did not read the summary carefully before signing it. The "discharge summary" refers the reader to the "admission note" for information regarding E.L.'s "physical examination." E.L.'s "hospital course" is described as follows in the "discharge summary:" The patient was admitted to my care, admitted to my service, placed on rest. Consultations were called. Venous studies were ordered. She was placed at complete bed rest. The foot of the bed elevated on two blocks. She was started on a 1500 calorie diet. Platelet count times three days was obtained. She started on heparin lock and IV heparin and started on heparin 3,500 units q.4h. a.m., 12 noon, 4 p.m., 8 p.m., 12 midnight, 4 a.m., etc. Daily prothrombin time and partial thromboplastin time were drawn one- half hour before 8 a.m. dose of heparin. She was given Ventolin, Restoril, Tylenol Extra-Strength. Consultations were called. The patient was started on respiratory treatments, Coumadin and was doing well. She started improving slowly but surely and finally on 4/21/92 in a stable condition, the patient will be discharged. The "discharge summary" indicates that "[d]ischarge medications were provided to the patient," but does not specify what medications were provided. Although neither the "discharge summary" nor any other record maintained by the hospital or Respondent so indicates, Respondent prescribed Coumadin for E.L. to use following her discharge from the hospital. In conjunction therewith, he provided E.L. with instructions regarding the proper use of Coumadin, but did not document in his records that such instructions were given. In treating E.L. with the anticoagulants Coumadin and Heparin, Respondent failed to practice medicine with that level of care, skill and treatment that, in light of the surrounding circumstances, a reasonably prudent medical doctor would have recognized as being acceptable and appropriate at the time. Because of the dangers involved in the use of anticoagulants, a reasonably prudent medical doctor would have carefully monitored E.L.'s condition and had her undergo further testing to confirm that she did indeed have thrombophlebitis before starting her on anticoagulant therapy.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby recommended that the Board enter a final order finding Respondent guilty of the violations of subsection (1) of Section 458.331, Florida Statutes, noted above, and disciplining him for having committed these violations by issuing him a reprimand, fining him $5,000.00 and placing him on probation for two years, subject to the condition that he complete 15 hours of continuing medical education in the area anticoagulant therapy and with the provision that when he completes the required continuing medical education the remainder of his probationary period shall be suspended. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 15th day of December, 1994. 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 15th day of December, 1994.
The Issue The issue to be resolved in this proceeding concerns whether the Respondent's medical licensure should be subjected to discipline for the reasons asserted in the Administrative Complaint, involving his alleged malpractice concerning patient, E.L.
Findings Of Fact The Respondent at all times material hereto has been a licensed physician in the State of Florida, having been issued License No. ME0030859. The Respondent practices at 1800 N.E. Street, Suite 521, Pensacola, Florida 32501. The Petitioner is an agency of the State of Florida. It is charged by the Legislature, as pertinent hereto, with enforcing the provisions of Chapter 458, Florida Statutes, and related rules, pertaining to the regulation of licensure and the quality of practice of medical doctors within the State of Florida. The Respondent is a board-certified dermatologist, practicing that specialty in the State of Florida in excess of 15 years. There is no evidence of any prior disciplinary action against the Respondent's licensure nor of any prior instance when his practice failed to conform to appropriate professional standards. In the course of his practice, the Respondent sometimes does his own microscopic pathological examination of tissue samples taken from patients (biopsies) on occasions when he deems it appropriate and that a consulting opinion is not required. It is undisputed by the parties that a dermatologist such as the Respondent, who had extensive training in dermatopathology during his medical education, can appropriately do such biopsy work within the standard of care of a reasonable physician practicing under similar conditions and circumstances. If he does so, however, he is held to the standard of a dermatopathologist in the course of his professional practice. The Respondent treated E.L. (an 80-year-old male patient at times pertinent hereto) since approximately 1982 for various problems involving pathology of the skin, including skin carcinoma. On November 21, 1991, E.L. presented as a patient of the Respondent showing a crusty area measuring approximately 1 x 2 centimeters on the vertex of his scalp or the back of his head. The lesion in question appeared on the skin with a hard crust, whitish or yellowish in color, and the Respondent diagnosed it as hypertrophic actinic keratosis. This is sometimes a pre-cancerous condition of the skin. Upon making his diagnosis, which he did clinically, without biopsy, the Respondent performed a curettage, or scraping of the tissue, to remove and destroy it. He did this by injecting the area with lidocaine as an anesthetic before performing the curettage. The Respondent had previously treated the same sort of condition on E.L. with liquid nitrogen but chose, this time, to treat the lesion with extension cautery and curettage. He did this because he was attempting to lessen the discomfort in his 80-year-old patient, who had already undergone a number of procedures to remove pre-cancerous or cancerous lesions of the skin on his head. The use of liquid nitrogen and the associated burning of the tissues involved would cause more difficult healing and discomfort for the patient. The treatment which the Respondent accorded the actinic keratosis condition, by curettage, is an acceptable, appropriate treatment for such a condition. It is undisputed by either the Petitioner's or the Respondent's expert witnesses, as well as the Respondent in his testimony, that such a clinical diagnosis and the following treatment by curettage is within the professional standard of care and practice by dermatologists practicing under similar conditions and circumstances. A biopsy is not a necessary prerequisite to such treatment. After the November 21, 1991 destruction of the skin lesion, the patient did not return for approximately one month. On December 19, 1991, he returned to the Respondent concerned about possible infection at the removal site. The Respondent, however, detected only granulation tissue, which are normal granular projections on the surface of a normally-healing wound. Consequently, there was no reason within the bounds of reasonable medical treatment standards for the Respondent to have biopsied the lesion area on that office visit occasion, either. Patient E.L. returned on January 3, 1992, at which point the Respondent noted a minor area of "dermatitis" or a non-cancerous inflammation of the skin, for which he prescribed a cortisone ointment. The Respondent did no biopsy at that time, either, and the clear and convincing evidence does not demonstrate that a biopsy was required under those conditions and circumstances within acceptable, reasonable bounds of the Respondent's professional practice. Patient E.L. returned to the Respondent on January 23, 1992 complaining of unsatisfactory progress with the healing of the lesion. The lesion by that time had become a rounded, raised growth with central cratering, characteristic of a keratoacanthoma. The Respondent examined the lesion or tumor clinically and determined that it appeared to be a keratoacanthoma. A keratoacanthoma is a rapidly-growing nodule with a central "crater", which then fills with a crusty material. It usually remains localized and most often resolves itself spontaneously, even if untreated. On very rare occasions does it become an aggressively-growing tumor. The Respondent biopsied the suspected keratoacanthoma by performing an excision of the area. He excised the nodule, taking a narrow margin of several millimeters around it and then performed a suture closure of the wound. He performed a biopsy of the tissue thus taken himself and interpreted the biopsy results approximately one week later as confirming his clinical diagnosis of a keratoacanthoma. Keratoacanthoma is regarded as a "low-grade" form of squamous cell carcinoma. The diagnosis is based upon a clinical observation with the naked eye, based upon history, as well as by pathological diagnosis. Conservative treatment is appropriate for a keratoacanthoma since they often resolve themselves spontaneously. Simple observation, surgical excision, curettage with or without electro-desiccation, radiation therapy, intra-lesional injection, and topical application of 5-fluorouracil and methotrexate are all acceptable forms of treatment for keratoacanthoma and can be reasonably expected to cure the condition. On rare occasions, keratoacanthoma can recur, even with such treatment. The diagnosis and treatment of keratoacanthoma is a matter of good- faith differences of opinion among reasonable dermatologists and pathologists, based upon their clinical judgment and experience. Some diagnose it as keratoacanthoma, which is a low-grade form of squamous cell carcinoma; and some diagnose it as squamous cell carcinoma with varying degrees of "differentiation". The photograph of the lesion as it was seen by the Respondent prior to the January 23, 1992 surgery shows a lesion consistent with the clinical appearance of a keratoacanthoma. The Respondent has been properly trained as a dermatologist in dermatopathology, and he commonly reviews biopsy and pathology slides. He is not required, under pertinent practice standards, to seek consultation when he believes that he has made a proper diagnosis. It was proper for him to read and review the pathology slide of the biopsy specimen, even though he himself acknowledges, as do the two expert witnesses, that he would be held to a dermatopathologist's professional practice standard by doing so. The Respondent opined that actinic keratosis developed into the keratoacanthoma. Dr. Breza, the Petitioner's expert witness, opined that actinic keratosis does not develop into keratoacanthoma but, rather, into squamous cell carcinoma. Even he acknowledged, however, that good pathologists have trouble making the diagnosis of keratoacanthoma and prefer generally to diagnosis such conditions as simply "low-grade" squamous cell carcinoma. Dr. Hanke, in his testimony, established that keratoacanthoma and squamous cell carcinoma are different gradients of diagnosis on the same continuum or range describing squamous cell carcinoma. That is, in lay terms, a keratoacanthoma is a "low-grade" squamous cell carcinoma. They are not precisely the same diagnosis, but both diagnoses describe the same general type of cells. As shown by Dr. Breza, squamous cell carcinoma tumors or lesions generally tend to appear somewhat flatter than that characteristic of a keratoacanthoma. Squamous cell carcinomas tend to be more indurated or firm on the outer edges and to have more inflammation on the outer edges, including occasional ulceration. The Respondent's description in E.L.'s medical record seems more consistent with squamous cell carcinoma, but the photographic images of the growth or lesion at issue, made at the time the biopsy and excision was performed, appear also consistent with keratoacanthoma. Based upon the information, including clinical appearance, that the Respondent had to consider in making his diagnosis and given that reasonable pathologists can differ concerning the gradients of diagnosis of squamous cell carcinoma (which includes keratoacanthoma), as shown by the expert testimony, the Respondent's diagnosis does not constitute a departure from appropriate, professional standards. The deficiency in the Respondent's practice in this instance began with the excision made on January 23, 1992. The Respondent took the tissue material from the excision for biopsy and, after pathological examination of the sample, diagnosed the nodule as keratoacanthoma. The Respondent, however, did not establish a "negative margin" for the excision. That is, the tissue removed had positive margins, especially the deep margin, which means that carcinoma cells could be observed on the surface of the piece of tissue removed. This means that the Respondent could not be assured that carcinoma cells did not remain in the tissue area surrounding the walls of the excision site because the margin of the excision around the nodule to be removed was not wide enough. The same slide and tissue sample which the Respondent used for biopsy in January 1992 was examined by a dermatopathologist, but not until some six months later, in July 1992. The dermatopathologist reported his opinion that the biopsy showed an "infiltrating squamous cell carcinoma with involvement of the lateral and deep margins." An infiltrating carcinoma implies that it is a more aggressive tumor than would be the case with a normal keratoacanthoma. The Respondent did not report those positive margins from the results of his excision and biopsy in January 1992. His testimony indicates that he may have seen them or been aware of them but did not make a larger incision in order to achieve a negative margin because of his concern about the complicated closure techniques that would be necessary. He was concerned with attendant additional discomfort to this elderly patient, as might be entailed with the possible use of grafting in order to make closure of the wound. He also seemed to discount the need to excise a larger margin because of his belief that he was dealing with a non-aggressive keratoacanthoma. In fact, however, the clear and convincing evidence shows that a larger margin wound could have been excised without the necessity for more elaborate techniques of closure and attendant discomfort to the patient. Moreover, it was established that even this elderly patient, with his attendant heart problems, could have tolerated a more elaborate excision of the tumor in question, since the procedure could still be done under low-risk local anesthesia in the Respondent's office. An infiltrating carcinoma is one which is more aggressive. It can move from its original location and infiltrate the skin and blood vessels, which can, in some cases, result in the tumor spreading via the blood stream or by infiltrating the lymphatic system, with migration to regional lymph nodes. The squamous cell carcinoma is not known for being a readily metastasizing form of cancer. It is known on some occasions to metastasize, however. The finding of positive margins on the pathological examination in July 1992 means that the tumor extended to the cut surface of the excision at the time of the January excision procedure from which that biopsy sample was taken. Thus, tumor cells remained in the patient's scalp after the January 1992 excision procedure. The finding of a positive margin requires that another margin be established, meaning that the physician must cut another level of tissue until normal skin (a negative margin) is revealed. This can be done by conventional surgery, by just a larger excision area being removed, or by "MOHS" surgery, which involves freezing sections of the excision area, with small portions of the suspicious area removed at a time and with attendant pathology examinations so that each "thread" of cancer cells can be removed with minimal damage to surrounding tissues and less attendant discomfort and healing problems associated with the resulting surgical wound. The patient could have tolerated either type of procedure in January 1992. The Respondent did not establish a negative margin, however. He only excised the carcinoma once. He stated that he was really seeking only a biopsy sample and that he considered the treatment by excision of the nodule itself and attendant scraping of the wound to be adequate as conservative treatment, to take care of what he believed to be a non-aggressive keratoacanthoma. This may be a correct assessment if the physician is certain that he is confronted with a non-aggressive, non-infiltrating keratoacanthoma. However, if positive margins to the excisional wound result, the patient is better served, and a successful treatment result much more likely, if all suspected carcinoma cells are removed at that time. If the Respondent knew of the positive margins to the excision and had made an additional excision to remove all positive margins, the provision of additional, more elaborate treatment techniques would not have been delayed for nearly six months and likely would have been unnecessary. The determination of the existence of positive margins, after the January 1992 excision procedure, should have caused him to remove additional tissue to obtain a safe, negative margin. That failure of care, in his capacity as a dermatopathologist, resulted in a six-month delay before the dermatopathologist, at Sacred Heart Hospital, identified the positive margins. He identified them on the Respondent's same January 1992 pathological slide, when he examined it in July 1992, after which radiation and further more radical treatment was attempted. Thus, the delay in treatment action, resulting from the delay in acting on the existence of positive margins by the Respondent, resulted in a six-month delay in appropriate treatment being provided the patient, which is a deviation from the accepted standard of care, as established by the testimony of Dr. Breza, which is accepted in this regard. Earlier determination (or acting on a determination) of the positive margins, after the January 1992 excision procedure would have alerted the Respondent that the excision procedure was unsuccessful and that further treatment was necessary. The patient's lesion occurred on a sun-damaged scalp. The Respondent had treated the patient repeatedly for sun-damaged skin problems, including carcinomas, in the past. Squamous cell carcinomas can be susceptible to mestastases, either regional or systemic when they are located on the scalp, although they are much less susceptible to such mestastases than if they are located on the lip or possibly the dorsal surface of the hand. The Respondent, as a board-certified dermatologist, knew or should have known that the scalp is an area of the body that can be susceptible to metastatic disease such as squamous cell carcinoma. The patient, as even acknowledged by the Respondent's expert, Dr. Hanke, was one with a high risk for developing skin cancer. In any event, after the excision procedure on January 23, 1992, the patient was seen on February 10, 1992 for removal of sutures and examination of the wound. It appeared to be healing nicely at the time, and the patient was advised to return to the Respondent in three months, unless a problem developed. The Respondent next saw the patient on April 6, 1992, when he complained of persistent pain at the excision and tumor site. This was treated by the Respondent by drainage, antibiotics, narcotic pain medications, and sleep- inducers. Later during the treatment regimen, in approximately May 1992, the Respondent felt that chemotherapy was indicated because apparently, the lesion had not been completely excised. Consequently, he prescribed injections of intralesional cortisone methotrexate and 5-fluorouracil. These, however, did not produce satisfactory healing or control of the pain. During April and May 1992, the Respondent saw the patient for complaints of persistent pain, poor healing, and drainage of the wound. On May 18, 1992, the Respondent performed a drainage of the lesion which had begun to show an abscess formation. An abscess formation is an indicator of squamous cell carcinoma, which should have been recognized by the Respondent. This should have alerted him that his diagnosis of simply keratoacanthoma was not correct, at least by that time. With the presence of these continuing and exacerbated problems with the wound site, the Respondent did not seek or perform further biopsy of the tumor site, despite continued complaints of persistent pain and further growth of the lesion between April and July 1992. The patient made 16 visits to the Respondent between April 1992 and July 14, 1992 for treatment and pain relief. During this time, little improvement occurred in the patient's condition, but no additional biopsy or consultation was requested or performed by the Respondent. The lack of improvement in E.L.'s condition during the period of April through July 1992 should have alerted the Respondent that something was incorrect about the patient's condition and that more extensive radical treatment would be necessary. In fact, the Respondent did respond to the continued complaints by, in addition to prescribing antibiotics and pain medication, prescribing the above- referenced intralesional injections of cortisone, methotrexate, and 5- fluorouracil. On July 9, 1992, another curettage procedure was performed and the pathology of the scrapings was sent for evaluation by a pathologist. The Respondent's interpretation of this tissue at the time apparently was a keratoacanthoma; well-differentiated squamous cell carcinoma. This was ultimately described by the pathologist to whom it was referred as a moderately- differentiated squamous cell carcinoma. Subsequently, after the C&D procedure, the patient was referred to Baptist Hospital in Pensacola, Florida, for radiation therapy. He received a full-course of radiation therapy with some booster therapy afterward and then, on his own volition, went for a second opinion to the University of South Alabama Medical Center in Mobile, Alabama. Five physicians at that facility recommended more extensive surgery, which ultimately the patient refused. There is no clear and convincing evidence that, at least at that point in the patient's progress, the persistent tumor had actually mestastized, although it was apparently growing locally. The fact that the lesion at issue was failing to heal and producing persistent pain by the visit of April 6, 1992 should have been interpreted so as to set in motion further investigative procedures, including an additional biopsy, to find out the reason for that condition and its persistence. Although a proper procedure involving excision and biopsy was done in January of 1992, the frozen sections of the lesion could have been interpreted to show that the tumor was an infiltrating carcinoma extending to the lateral and deep margins of the excision and something more aggressive could have been done to treat it at that time. It could have either been re-excised with frozen section control of the margins, referred to a "MOHS'" surgeon for a similar type of surgery or referred to a general surgeon. Radiation therapy could have been tried, at least by the time the persistence of the problem was determinable in April of 1992. The resultant reduction of delay in securing more extensive treatment of the lesion would have certainly benefited the patient. The persistence of the pain in the six-month period of time after the January 1992 excision of the tumor, until just before the time the patient was referred for radiation therapy indicates there was probably perineural invasion by the tumor (infiltration of the nerves), which produced pain. This should have alerted the Respondent that something more than a non-aggressive keratoacanthoma was involved, as well. In summary, it has been demonstrated that the Respondent failed to practice medicine within that level of care, skill and treatment recognized by reasonably prudent, similarly-situated physicians as acceptable under the circumstances, by failing to make an additional biopsy after the patient re- presented with problems associated with persistent pain and improper healing in April 1992; by failing to recognize and act on the presence of positive margins to the excision material taken in January 1992, to effect an additional excision at that time, so as to secure a safe, negative margin to the tumor. The failure to obtain consultation on the biopsy taken from a dermatopathologist was not in itself evidence of falling below appropriate professional levels of care, skill and treatment, but the Respondent, by doing his own interpretation of the biopsies was, as he agrees, creating a situation in which he would be held to the same standard as a dermatopathologist. The failure to correctly interpret the biopsy he took in January 1992, by failing to recognize the positive margins to the excised material and failing to act to remove those indicia of the continued presence of the tumor, at a time when it was thus easily excised, likely prevented an easily-effected cure.
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence of record, the candor and demeanor of the witnesses, and the pleadings and arguments of the parties, it is RECOMMENDED that the Respondent be found guilty of a violation of Section 458.331(1)(t), Florida Statutes, in the manner concluded above, and that the Respondent receive a private reprimand, a $2,000.00 fine, and that he be required to attend 20 additional hours of Category I continuing medical education in the area of diagnosis and treatment of skin cancer. DONE AND ENTERED this 30th day of October, 1995, in Tallahassee, Florida. P. MICHAEL RUFF, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 30th day of October, 1995. APPENDIX TO RECOMMENDED ORDER, CASE NO. 94-3531 Petitioner's Proposed Findings of Fact 1-8. Accepted. 9-10. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. Accepted, but not itself materially dispositive. Rejected, as contrary to the clear and convincing evidence. The evidence does not reflect that one biopsy sample only showed one part of the lesion at issue but, rather, several parts were represented. Accepted. Accepted, but not itself materially dispositive. 15-21. Accepted. 22-24. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 25-26. Accepted. 27. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 28-36. Accepted. 37-41. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 42-44. Accepted. 45. Rejected, as contrary to the clear and convincing evidence and subordinate to the Hearing Officer's findings of fact on this subject matter. 46-53. Accepted, but not in their entirety materially dispositive. 54. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 55-56. Accepted. Rejected, as not in its entirety supported by clear and convincing evidence of record. Accepted. Accepted, to the extent of failing to practice medicine within the appropriate standard of care by not making earlier and more frequent biopsies only. Respondent's Proposed Findings of Fact 1-17. Accepted. 18. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 19-20. Accepted. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter, and as not entirely in accord with the clear and convincing evidence of record. Accepted. Accepted, but not necessarily as to its material import and subordinate to the Hearing Officer's findings of fact on this subject matter, which contain additional findings of fact not contained in Proposed Finding of Fact No. 23 and which are material, relevant, and necessary to a clear picture of the patient's progress and treatment rendered during the period of April 6, 1992 through July 14, 1992. Accepted, but not as to its purported material import. Rejected, as contrary to the clear and convincing evidence of record, and as subordinate to the Hearing Officer's findings of fact on this subject matter. Accepted, but not as to its purported material import. 27-31. Accepted. COPIES FURNISHED: Britt Thomas, Senior Attorney Mary Anne Davies, Certified Legal Extern Agency for Health Care Administration 1940 North Monroe St., Ste. 60 Tallahassee, FL 32399-0792 Donald Partington, Esq. CLARK, PARTINGTON, ET AL. Post Office Box 13010 Pensacola, FL 32591-3010 Dr. Marm Harris Executive Director Board of Medicine Agency for Health Care Administration 1940 North Monroe Street Tallahassee, FL 32399-0770 Jerome W. Hoffman, Esq. General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, FL 32309
The Issue The issue is whether Respondent is guilty of performing wrong-site surgery or performing a procedure without the patient's consent and, if so, what penalty should be imposed.
Findings Of Fact At all material times, Respondent has been licensed as a physician in the state of Florida. His license number is ME 85786. Respondent is Board-certified in anesthesiology and pain management by the American Board of Anesthesiology. Respondent has not previously been disciplined by the Board of Medicine. Patient K. D. suffered a back injury in November 1998. Following a laminectomy, Patient K. D. continued to suffer from chronic low-back pain. She visited Respondent's pain management clinic for pain relief and has been quite satisfied with the treatment that she has received from Respondent. On February 14, 2003, one of Respondent's partners performed a right-side lumbar rhizotomy by pulsed radiofrequency. The purpose of this procedure is to relieve or eliminate pain in the lower back. When performed by pulsed radiofrequency, the rhizotomy would probably not have been successful if the patient still experiences pain two weeks after the procedure. Two weeks later, on February 28, Patient K. D. presented for a left-side lumbar rhizotomy, which Respondent was to perform. Immediately prior to the surgery on February 28, while Patient K. D. was in pre-op, Respondent performed a physical examination and observed that Patient K. D. indicated pain on the right side. In response to questioning, Patient K. D. confirmed that her right side was more painful than her left side. Respondent said that he would therefore perform a right-side lumbar rhizotomy. Patient K. D. did not disagree or object, but consented to the procedure--in the presence of two nurses, as well as Respondent. Immediately after their pre-op discussion, Patient K. D. was administered Versed, which produces an effect of amnesia. To some extent, this drug may cause some retrograde amnesia, so that Patient K. D. might not recall events immediately preceding the administration of the drug, such as her physical examination and conversation with Respondent in pre-op. Respondent performed a right-side lumbar rhizotomy without incident. However, immediately after the procedure, Patient K. D. said that she also suffered left-side pain and questioned why Respondent had performed the procedure on her right side. When Patient K. D. complained that transportation problems would make it hard for her to re-schedule a left-side procedure, Respondent performed a left-side procedure, on the same day, and he completed this procedure also without incident. Prior to the February 14 and 28 procedures, Patient K. D. signed consent forms. The consent form for the February 14 procedure identifies a right-side procedure, and the consent form (actually, there are two identical forms) for the February 28 procedure identifies a left-side procedure. The forms state: It has been explained to me that during the course of an operation, unforeseen conditions may be revealed that necessitate an extensive exchange or change of the original procedure or different procedures, and I therefore authorize and require my physician or surgeon . . . to perform such surgical procedures as are necessary and desirable in the exercise of his and/or their professional judgement. . . . Petitioner's expert witness opined that a change in location, even under the above-described circumstances, "should" have been documented on a consent form, but later conceded that this is not strictly necessary. On cross-examination, Petitioner's expert witness admitted that a patient may give informed consent verbally or by conduct. Petitioner's expert witness properly discredited Respondent's theory that he had some form of ongoing consent because the forms bore no expiration date. However, to the limited extent that Petitioner's expert witness implied a requirement for written informed consent, his opinion is unsupported by Florida law, as set forth below. In contrast to Petitioner's expert witness, Respondent's expert witness did not equivocate on the issue of the required form of informed consent. Relying largely on the testimony of Patient K. D., Respondent's expert witness testified that Respondent had obtained the informed consent of Patient K. D. to perform a second right-side procedure. Aside from the obvious advantages of a written informed consent, Respondent's expert witness convincingly testified that informed consent is a state of mind, not a signature on a piece of paper, and, by this standard, which is consistent with Florida law, as set forth below, Respondent had Patient K. D.'s informed consent to perform a second right-side procedure on February 28 and thus had been duly authorized to do so.
Recommendation It is RECOMMENDED that Petitioner dismiss the Administrative Complaint, as amended, against Respondent. DONE AND ENTERED this 21st day of November, 2005, in Tallahassee, Leon County, Florida. S _ ROBERT E. MEALE 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 21st day of November, 2005. COPIES FURNISHED: Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Timothy M. Cerio, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Irving Levine Assistant General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Dennis A. Vandenberg Peterson Bernard 1550 Southern Boulevard West Palm Beach, Florida 33406
The Issue Through the several administrative complaints to which these cases pertain, Petitioner seeks to take disciplinary action against the medical license held by the Respondent. The alleged misconduct is more fully described in the discussion that follows.
Findings Of Fact Findings of fact set forth in the Recommended Order as modified by the Board's rulings on the Supplemental Exceptions, are approved and adopted and incorporated herein. Specifically, Paragraphs of the Findings of Fact 15, 24, 34, 43, 46, 60, 79, 98, and 108 were modified. There is competent substantial evidence to support the findings of fact of the Board.
Recommendation Upon the consideration of the facts found and the conclusions of law reached, it is, RECOMMENDED: That a Final Order be entered which revokes Respondent's license to practice medicine in Florida. DONE and ENTERED this 30th day of December, 1992, in Tallahassee, Florida. CHARLES C. ADAMS Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 30th day of December, 1992. APPENDIX The following discussion is given concerning the proposed facts of the parties: Petitioner's Facts: Facts on Expert Witnesses: Paragraphs 1 through 31 are not necessary to the resolution of the dispute. Paragraphs 32 through 38 constitute legal argument. Patient Kelly John: Paragraphs 1 through 4 are subordinate to facts found. Paragraphs 5 and 6 are not relevant in that the D&C was not performed. Paragraphs 7 through 19 are subordinate to facts found. Paragraph 20 is not necessary to the resolution of the dispute. Paragraphs 21 through 28 are subordinate to facts found. Patient Dottie Akers: Paragraphs 1 and 2 are subordinate to facts found. Concerning Paragraph 3, the surgery by Dr. Becker and its findings standing alone do not form the basis for determining the appropriateness of Respondent's efforts to reestablish fertility. Paragraphs 4 through 18 are subordinate to facts found. Paragraphs 19 through 22 constitute legal argument. Paragraphs 23 through 54 are subordinate to facts found. Paragraphs 55 and 56 are not necessary to the resolution of the dispute. Paragraphs 57 and 58 are subordinate to facts found. Patient Lillian Andrews: Paragraphs 1 through 18 are subordinate to facts found. Patient Emily Rivera: Paragraphs 1 through 23 are subordinate to facts found. Paragraph 24 is contrary to facts found in that the patient had taken birth control pills for thirteen years not ten years. Paragraphs 25 through 27 are subordinate to facts found. Paragraph 28 is not accepted. Paragraph 29 is subordinate to facts found. Patient Balenda Fulton: Paragraphs 1 through 6 are subordinate to facts found. Paragraphs 7 is not necessary to the resolution of the dispute. Paragraph 8 is subordinate to facts found. Paragraphs 9 and 10 are not necessary to the resolution of the dispute nor is paragraph 11. Facts were found found concerning the patient's two children. Paragraphs 12 through 15 are subordinate to facts found. Paragraph 16 is not accepted. Paragraphs 17 and 18 are subordinate to facts found. Paragraph 19 is not necessary to the resolution of the dispute. Paragraphs 20 through 34 are subordinate to facts found. Respondent's Facts Paragraph 1 is subordinate to facts found. Paragraphs 2 through 4 are not necessary to the resolution of the dispute. Paragraphs 5 through 7 are subordinate to facts found. Paragraphs 7 through 9 are not necessary to the resolution of the dispute. It is noted that notwithstanding Dr. Rudolph's reservations concerning his objectivity, on balance his testimony was deemed an appropriate subject for consideration together with the observations of the other experts. Paragraph 10 is spoken to in the preliminary matters to the Recommended Order. Paragraph 11 is subordinate to facts found. Paragraphs 12 and 13 are not necessary to the resolution of the dispute. Paragraph 14 is subordinate to facts found. Paragraph 15 is subordinate to facts found with the exception of the reported advice to the patient to have a tubal reanastomosis that is not accepted. Paragraph 16 through 25 are subordinate to facts found. Paragraph 26 is is not necessary to the resolution of the dispute. Paragraphs 27 through 30 are subordinate to facts found. Paragraph 31 is rejected in that it suggests that there were existing fimbriated ends of the fallopian tubes. Paragraphs 32 through 39 are subordinate to facts found. Paragraphs 40 through 42 constitute legal argument. Paragraph 43 is subordinate to facts found. Paragraphs 44 through 47 are contrary to facts found. Paragraphs 48 and 49 are subordinate to facts found. Paragraph 50 is contrary to facts found. Paragraph 51 is subordinate to facts found. Paragraph 52 is contrary to facts found. Concerning Paragraph 53 while it is not necessary to record instructions about the use of Danazol, Respondent did not perform the needed task of oral instruction. Paragraph 54 is subordinate to facts found with the exception of references to pain two to three days prior to menses. That suggested fact finding is rejected as is Paragraph 55 to the extent that it is dependent upon that fact. Paragraph 56 is rejected in its suggestion that extensive endometriosis was present. The same response is made to the fact finding suggested in Paragraph 57. Paragraphs 58 through 63 are subordinate to facts found. Paragraph 64 is not necessary to the resolution of the dispute. Paragraph 65 is not accepted as to the extent that the proposed finding suggests performing a laparoscopic examination on that limited information. Reference in Paragraph 66 to the civil suit is not necessary to the resolution of the dispute. The balance of Paragraphs 66 through 71 are subordinate to facts found. Paragraphs 72 through 77 constitutes legal argument. Paragraph 78 is contrary to facts found in its suggestion that there was any pelvic exam performed. Paragraph 79 is rejected in its indication that there were any reports of pelvic pain prior to menses. Paragraph 80 is subordinate to facts found. Paragraph 81 is contrary to facts found in its suggestion that an adequate basis was being present to justify the laparoscopy. Paragraph 82 is subordinate to facts found. Paragraphs 83 is rejected as to purported findings on laparoscopy and laparotomy. Paragraph 84 is subordinate to facts found. Paragraph 85 is contrary to facts found. Paragraph 86 is not necessary to the resolution of the dispute. Paragraphs 87 through 94 constitute legal argument. Paragraph 95 is subordinate to facts found. Paragraph 96 is not accepted in its depiction of a complaint of menometrorrhagia, same for paragraph 97. Paragraphs 98 through 101 are contrary to facts found in their suggestion that the D&C and hysterocopy were performed. Paragraphs 102 and 103 are subordinate to facts found. As to Paragraphs 104 and 105 and their suggestion that Respondent instructed the patient concerning ectopic pregnancy those Paragraphs are contrary to facts found as are Paragraphs 106 through 108. Paragraphs 109 and 110 are subordinate to facts found. Paragraphs 111 through 117 constitute legal argument found. Paragraphs 118 through 121 are accepted but are not necessary to be reflected in the fact finding. COPIES FURNISHED: Susan E. Lindgard, Esquire Michael Blazicek, Esquire Department of Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792 Julie Gallagher, Esquire Sandra Stockwell, Esquire Post Office Box 11059 Tallahassee, FL 32302 Dorothy Faircloth, Executive Director Department of Professional Regulation Board of Medicine 1940 North Monroe Street Tallahassee, FL 32399-0792 Jack McRay, General Counsel Department of Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant facts are found: At all times relevant to this proceeding, respondent, Manihi G. Mukherjee, has been a licensed physician in Florida, holding license number ME 0027749. She received her medical degree in New Delhi, India, in 1965. Respondent is Board certified in obstetrics and gynecology and is a Fellow of the American College of OB/GYN. She attends conferences regularly and has attended more than 150 hours of continuing medical education courses between 1979 and 1987. Since 1976, she has been in private practice in St. Petersburg, Florida, specializing in obstetrics and gynecology. Respondent first saw patient J.B. on November 30, 1979, for a routine gynecological examination and renewal of birth control pills. While obtaining an initial history on the patient, respondent learned that J.B. had a previous appendectomy performed in 1973, and noted the surgical incision located in the right lower quadrant. During a visit to respondent on or about September 9, 1980, J.B. told respondent that she wanted more information' about methods of contraception other than birth control pills. Respondent advised J.B. about the various alternative methods of contraception, including tubal ligation, as well as their effectiveness and complications. With regard to tubal ligation, respondent explained to J.B. that a bilateral partial salpingectomy using a mini-laparotomy could be performed for sterilization purposes and that the failure rate of such a procedure was 4 to 6 persons per 1,000. A laparotomy procedure involves the creation of an incision of about 8 to 10 inches in the anterior abdominal wall. A mini-laparotomy involves a smaller incision of between one and three inches. A salpingectomy is the removal of the fallopian tube. A partial salpingectomy is the removal of a portion of the fallopian tube. A bilateral partial salpingectomy is the partial removal of both fallopian tubes. On or about April 1, 1981, J.B. returned to respondent for a six-month check up, and advised respondent that she wanted to have a tubal ligation. Respondent again advised J.B. about the method of tubal ligation which would be used (the mini-laparotomy with bilateral partial salpingectomy) as well as the complications and failure rates of the procedure. Thereafter, on April 14, 1981, J.B. was admitted to what is now known as Humana Hospital Northside in St. Petersburg Florida, for elective tubal ligation. On that date, she signed a form entitled "Consent to Operation, Administration of Anesthetics, and the Rendering of Other Medical Services," authorizing respondent to perform a mini-laparotomy and a bilateral partial salpingectomy. While obtaining a further medical history from J.B. at the hospital prior to the scheduled surgery, respondent was informed that the patient had previously had an exploratory laparotomy in 1973, at the same time that the appendectomy was performed. On or about April 15, 1981, respondent performed a mini-laparotomy and what was described in respondent's records as a "bilateral partial salpingectomy" with a modified Pomeroy procedure on patient J.B. A Pomeroy procedure is a method of sterilization accomplished by picking up a loop of the fallopian tube, clamping across the loop, cutting and removing that portion of the loop above the clamp and ligating, or tying off, the tissue beneath the clamp with catgut sutures. Respondent modified the procedure by using chromic O sutures. In performing the surgery, respondent identified the left tube and ovary and ligated the loop of the tube. She then attempted to locate the right tube and ovary. Respondent visualized a distorted right tube, but did not see a right fimbria or a right ovary. The fimbria is the fringe-like outer end of the fallopian tube. Respondent testified that she assumed that the patient's right ovary and tube had been removed during the patient's previous exploratory laparotomy and/or appendectomy. Respondent sent specimens from what purported to be the right and left fallopian tubes to the pathology department for pathological evaluation. Her dictated operative report describes the following: "Operative Findings: On opening the abdominal cavity, her right tube was blocked, fibrial (sic) end was absent. Right ovary was absent. Left tube and ovary looked normal. Ovaries looked normal. Operative Procedure: . . . Both tubes were identified. They were held in their mid portion with the Bab- cock and transfixed with chromic O catgut suture... The loop of the right and left fallopian tube were transected and sent separately to the lab..." The pathological evaluation was performed on or about April 16, 1981. It revealed that the specimen identified as "Specimen A," which purported to be a portion of the right fallopian tube, contained sections of veins and fibrofatty tissue. Specimen A did not contain tubal matter. Specimen B contained, as expected, a portion of the left fallopian tube. The respondent was advised of the pathology evaluation report, though the time of such advice was not established. Patient J.B. remained hospitalized until April 7, 1981. Shortly after performing surgery on J.B., respondent advised J.B. that during the course of the operative procedure, respondent could not find a right ovary. However, she advised J.B. that there was nothing to worry about and that everything went well. After leaving the hospital, J.B. saw respondent on three more occasions. On April 20, 1981, respondent removed the staples from J.B.'s abdomen. She advised J.B. to remain on birth control pills for healing purposes. On May 15, 1981, and on June 8, 1981, respondent saw J.B. for postoperative visits. At the latter visit, J.B. advised respondent that she would be moving to Louisiana because of her husband's job. At no time did respondent advise J.B. that the pathological evaluation of the specimens submitted from the April 15, 1981, surgery revealed that the specimen purporting to contain a portion of tubal matter from the right fallopian tube did not in fact contain such material. At no time did respondent advise J.B. that respondent believed that the right tube was removed during the previous surgery performed in 1973. Respondent did not advise J.B. that she could become pregnant if the right tube were note properly blocked, and, therefore, that she needed to remain on birth control pills until the matter could be appropriately investigated. Respondent did not advise J.B. of the necessity to "follow-up" on the results of the pathology report by either obtaining records from the 1973 surgery to confirm respondent's belief that the patient's right fallopian tube was previously removed or by performing appropriate testing on J.B. to confirm blockage of the right ovary. On or about June 20, 1981, well after being apprised of the results of the pathological evaluation, respondent dictated a Discharge Summary for the hospitalization of J.B. from April 14-17, 1981. The Discharge Summary provided in pertinent part: Hospital Course: On April 15, 1981, a mini-laparotomy and partial bilateral salpingectomy was performed without any complications under general anesthesia. Postoperatively, the patient did fairly well. She was discharged on the second postoperative day with the advice to be seen in the office in one week. The Discharge Summary contained no reference to the results of the pathological evaluation. It also contains no documentation that respondent believed that the patient's right fallopian tube was removed during the 1973 surgery. On or about September 29, 1981, patient J.B. telephoned respondent's office because her period was two weeks late and a home pregnancy test had given a positive result. J.B. was informed that it was unlikely, but not impossible, that she was pregnant, and that with a tubal ligation procedure, a part of each tube is removed. On or about October 2, 1981, J.B. went to a physician in Louisiana and was determined to be pregnant. On October 7, 1981, she had an elective abortion. Following the termination of pregnancy, a diagnostic laparoscopy and a D & C (a scraping of the uterus) was performed on October 20, 1981. The laparoscopy revealed that the right ovary was present and a cyst was on the ovary. The right fallopian tube was present in its entirety (including the fimbria), was surgically untouched and was otherwise normal. The injection of methylen blue dye revealed that the fallopian tube was open and not blocked. A failed tubal ligation is not in and of itself malpractice or substandard care. However, a reasonably prudent physician, under the circumstances present in this case, should have immediately advised the patient that the possibility existed that one of the tubes had not been properly ligated, and, therefore, the possibility existed that the patient might become pregnant. The patient should have been advised to continue utilizing birth control methods until appropriate investigation could be undertaken to determine the condition of the right fallopian tube. A reasonably prudent physician would have then undertaken appropriate investigation. This could have included either the obtaining of previous medical records to confirm or deny that the right fallopian tube had been removed during the earlier surgical procedures performed in 1973, or the performance of a hysterosalpingogram. This latter procedure is a test which involves the injection of radiographic dye into the uterus and through the tubes. The dye is examined under x-ray to determine whether it flows freely through the fallopian tube or is stopped by blockage or ligation. The respondent admits that the term used in J.B.'s medical records to describe the procedure performed on the patient during her April, 1981, hospitalization was incorrect. Respondent did not perform a bilateral salpingectomy as noted in the Discharge Summary, but instead performed a left partial salpingectomy and excision of the tissue from the right tube. On September 5, 1981, patient R.L., an 18 year old female, was admitted to the emergency room complaining of abdominal pains. After examining the patient, the emergency room physician determined that R.L. was suffering from bilateral lower quadrant tenderness in the abdomen. A pelvic examination revealed bilateral tenderness in the adnexa and tenderness in the cervix. The impression of the emergency room physician was that R.L. had pelvic inflammatory disease (PID). PID is a progress of infection in the reproductive organs which can start in the vagina and spread to the cervix and progress upward to the uterine cavity, continue on outward to the fallopian tubes and involve the pelvis, either by direct continuous spread or through the blood supply and the lymphatics. It may be associated with either a bacterial or a viral type of infection. The emergency room physician ordered several tests to be conducted for the patient, including a complete blood count test. This test revealed that the patient's white blood cell count was 17,500. A normal count is approximately 7,800. R.L.'s white blood cell count was significantly elevated, indicating the presence of an infective process. The emergency room physician contacted the respondent, who agreed to assume the care of patient R.L. Respondent ordered the admission of the patient to the hospital, with a diagnosis of PID with peritonitis. Peritonitis is an inflammation of the peritoneum or lining of the abdomen. Upon admission, the respondent obtained an initial medical history and performed an initial physical examination on R.L. The medical history revealed that the patient had never had children, had been on birth control pills for one and one-half years, and she denied having had sexual intercourse for the past four months R.L. informed respondent that she had started having abdominal pain and a low-grade fever on the morning of the day before and that the pain had become increasingly worse and generalized, associated with some nausea and vomiting. The respondent's examination of the patient's abdomen and a pelvic examination revealed vague distention or bulging of the abdomen, muscle guarding and rigidity. Sluggish bowel sounds were audible, and there was marked tenderness and rebound tenderness in the patient's lower abdomen. The respondent's impression was acute PID with peritonitis. She ordered that R.L. be placed on intravenous fluids, that her vital signs be taken four times a day, that a chest x-ray be given, and that pain medication, aspirin, and antibiotics be administered. The respondent's main objective was to try to resolve the patient's PID conservatively, without performing surgery. R.L.'s daily progression varied with respect to her white blood cell count, her temperature, abdominal tenderness and rigidity, bowel sounds and daily activity between September 5 and 14, 1981. The patient's white blood cell count fell to 13,100 on September 7, and rose to 16,700 on September 9th. Her temperature would rise and fall on any given day. Her abdomen remained distended and rigid until September 12, when she began having less tenderness and better bowel sounds. She showed some improvement in her diet intake and in ambulation. The respondent ordered that various tests and changes of medication be performed between September 6 and 14, 1981. These included a urinalysis, a flat plate x-ray of the abdomen, an ultra sound of the abdomen and changes in antibiotics. On September 10, respondent performed a culdescentesis (the insertion of a needle into the cul-de-sac under general anesthesia), and withdrew ten cubic centimeters of frank pus. On September 11, respondent performed a colpotomy (a procedure in which an incision is made into the cul-de- sac through the upper wall of the vagina, into the peritoneal cavity) in order to drain the cul-de-sac. The patient appeared to improve somewhat after this procedure. On September 14, 1981, respondent requested Dr. Benjamin Abinales to perform a surgical consultation. Dr. Abinales' examination of R.L. on September 14 revealed that R.L.'s abdomen was slightly distended, with marked tenderness. He noted muscle guarding and rebound tenderness, and the presence of peristalsis. Dr. Abinales felt that the patient was suffering from pelvic peritonitis, and recommended that respondent continue the present plan of treatment for several days. If no improvement was evident, Dr. Abinales suggested that exploratory surgery be considered. The patient's condition did not improve after September 14th. Her white blood count value rose to 27,800 and her temperature was as high as 101 degrees on September 15, 1981. E-coli bacteria, usually found in the gastrointestinal system, were revealed from cultures performed on the pus drained during the culdescentesis. On September 16, the responded performed a second colpotomy, again draining frank pus. On September 17, R.L. was administered a new type of antibiotic, and this was changed again on September On September 18, a chest x-ray revealed that there was a possibility of a subphrenic abscess on the left side of the lungs with pleural effusion present. Thereafter, specialists in infectious diseases and pulmonary medicine were consulted. The infectious disease specialist recommended a CT Scan of the abdomen and surgical intervention after the CT Scan results were evaluated. On September 21, 1981, respondent and Dr. Abinales performed an exploratory laparotomy, lysis of extensive intestinal lesions, what was described as "removal of tubovarian abscess from the right side," an appendectomy, drainage of subphrenic abscess on the left side, and peritoneal lavage. The operative description of the exploratory laparotomy demonstrates that there was significant inflammation of the fallopian tube and the ovary on the right side and also significant inflammation of the appendix on the right side. Thus, the etiology of the infection could have been either an appendicitis with perforation or a tubo-ovarian abscess. Patient R.L. recuperated uneventfully after the surgery and was discharged from the hospital on October 4, 1981. Where possible, conservative treatment (non-surgical treatment) is the treatment of choice for PID. This is particularly true for young female patients of child bearing years. The accepted standard of practice for gynecologists is to initially pursue conservative treatment of PID with antibiotic therapy, especially in the presence of peritonitis, for a period of about 72 hours. Generally, if the proper antibiotics are administered, PID responds dramatically within 72 hours. If clinically significant improvement does not occur in that period, other complications, such as appendicitis or abscess formation, should be suspected and exploration of the abdomen surgically is necessary. The extent of surgical intervention required depends, in large part, on the condition of the abdomen as revealed on exploratory laparotomy. While a physician should be concerned about making every effort to preserve the reproductive organs in a young female, the need to preserve the reproductive system must be balanced against the need to preserve the patient's life, particularly where peritonitis exists.
Recommendation Based upon the findings of fact and conclusions of law recited herein, it is RECOMMENDED that respondent Manihi G. Mukherjee, M.D. be found guilty of violating Section 458.331(1) (m) and (t) , Florida Statutes, that she pay a fine o $2,500.00 and that she be placed on probation for a period of three years, with conditions and restrictions to be established by the Board of Medicine relating to her surgical assessment and care of patients and her record keeping. Respectfully submitted and entered this 28th day of September, 1988, in Tallahassee, Florida. Diane D. Tremor, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1500 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 28th day of September, 1988. APPENDIX TO RECOMMENDED ORDER CASE NO. 87-2283 The parties' proposed findings of fact have been fully considered and are accepted and/or incorporated in this Recommended Order, with the following exceptions: Petitioner 7. Rejected as irrelevant and immaterial to the issues in dispute. 13. Rejected as irrelevant and immaterial to the issues in dispute. 40. First sentence rejected as irrelevant. 49. Second sentence rejected as irrelevant. 61(b). Second sentence rejected as unsupported by competent, substantial evidence. 63. Rejected as unrelated to the charges in the Administrative Complaint. Respondent (as to J.B.) 11. Rejected as contrary to and inconsistent with the greater weight of the evidence. 13, 14, 15 and 17. Rejected as contrary to and inconsistent witch the greater weight of the evidence. (as to R.L.) 4. Rejected as unsupported by competent, substantial evidence. First sentence rejected as unsupported by the evidence. Rejected as contrary to the evidence. 9, 10 and 11. Accepted, except with regard to timeliness. 12. Rejected, as contrary to the greater weight of the evidence. COPIES FURNISHED: Stephanie A. Daniel Senior Attorney Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Donald V. Bulleit and Nelly Ehouzam Fowler, White, Gillen, Boggs, Villareal & Banker, P.A. P. O. Box 210 St. Petersburg, Florida 33731 Dorothy Faircloth Executive Director Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Bruce D. Lamb, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
