The Issue The issues for determination are whether Respondent Bernard Zaragoza, M.D., violated Section 456.072(1)(bb), Florida Statutes (2007), as alleged in an Administrative Complaint filed by the Department of Health before the Board of Medicine on June 30, 2008; and, if so, what disciplinary action should be taken against his license to practice medicine in the State of Florida.
Findings Of Fact The Parties. Petitioner, the Department of Health (hereinafter referred to as the "Department"), is the agency of the State of Florida charged with the responsibility for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. § 20.43 and Chs. 456 and 458, Fla. Stat. Respondent, Bernard J. Zaragoza, M.D., is, and was at the times material to this matter, a physician licensed to practice medicine in Florida, having been issued license number ME 67920. Dr. Zaragoza’s address of record is 3100 Coral Hills Drive, Suite 207, Coral Springs, Florida 33065. Dr. Zaragoza is certified in general surgery by the American Board of Surgery. Dr. Zaragoza has not been the subject of any investigation, claim, or complaint relating to his professional career other than this matter. Dr. Zaragoza graduated, Summa Cum Laude, from the University of Miami with a bachelors degree. He earned his medical degree from Harvard Medical School. Dr. Zaragoza performed a five-year surgical residency program at New York Medical College’s Westchester County Medical Center. During his residency, Dr. Zaragoza performed hundreds of laparoscopic procedures, including laparoscopic cholechstectomies (removal of the gallbladder). A laparoscopic surgery is a technique in which the abdomen is entered through small incisions rather than “opening up” the abdomen. Normally, for abdominal laparoscopic surgery, incisions are made at the belly button. This is the point which is usually closest to the peritoneal cavity, thus reducing the distance from the skin the surgeon must work through and the surgeon has a broader view of the abdomen. By October 2007, Dr. Zaragoza had performed in excess of 2,000 laparoscopic cholecystectomy procedures. Patient J.C. On October 1, 2007, Patient J.C., a male, 83 years of age, presented at Northwest Medical Center, located in Margate, Florida, for treatment of abdominal pain and vomiting. Patient J.C. had reported with the same symptoms a month earlier and had been diagnosed with chronic cholecystitis, a chronic inflammation of the gallbladder due to the blockage of the bile ducts by gall stones. It is a life-threatening condition. Patient J.C. was admitted by Rafael Rodriguez, M.D., who requested a consultation by Mark Shachner, M.D., Dr. Zaragoza’s partner. Dr. Shachner confirmed a diagnosis of acute cholecystitis and, in light of the failed conservative therapy which Patient J.C. had undergone since his first visit and the potential threat to his life, Dr. Shachner recommended surgery. It was concluded that Patient J.C. would undergo an attempted laparoscopic cholecystectomy. Dr. Zaragoza was to perform the procedure. It was concluded that a laparoscopic procedure was the appropriate procedure for Patient J.C. due to his medical history: atrial fibrillation, Alzheimer’s disease, hypertension, and diabetes. He had also undergone prior abdominal procedures. The parties did not dispute that a laparoscopic procedure, because it was likely to reduce post- operative complications, was the best type of surgical procedure for Patient J.C. Patient J.C., as a result of a prior gastrectomy, had a long midline incision extending from the Xiphoid upper abdomen to below the belly button. As a result of this surgery, Patient J.C. had extensive adhesions of tissue up to the midline. Patient J.C. had also undergone an appendectomy. It was concluded that, due to Patient J.C.’s condition and abdominal surgical history, rather than entering at the belly button and risking injury to any structures that were adhesed to the midline, a “right-sided” incision point would be used. The Department does not dispute the appropriateness of this decision. Unfortunately, by using a right-sided incision point, Dr. Zaragoza’s visualization of Patient J.C.’s abdominal cavity was reduced. Patient J.C. and his family were fully informed of the nature of the proposed surgical procedure and the risks, after which Patient J.C. signed a written consent for surgery. The written consent included an authorization to “take whatever action(s) and to perform whatever procedures(s) they deem necessary and advisable, which may be in addition to or different from those now planned” and an acknowledgement that the surgery to be performed “may result in perforation or injury to adjacent organs or structures.” None of the witnesses convincingly testified that the authorization included the authority to remove healthy organs or that the acknowledgement included any suggestion that a healthy organ might be completely removed. Surgery was scheduled for October 2, 2007. Dr. Zaragoza began the surgery with a right-sided approach, freeing up the area and attempting to identify important structures in the right upper quadrant of the abdomen. In particular, the important structures Dr. Zaragoza attempted to locate were the liver, colon, and the gallbladder. Dr. Zaragoza encountered extremely heavy adhesions (8 on a scale of 1 to 10) in Patient J.C.’s abdomen. Dr. Zaragoza considered the risks of continuing or switching to an open abdomen procedure and correctly concluded it was best to proceed. Dr. Zaragoza freed up extensive adhesions and was able to correctly identify the liver. Unable to identify the gallbladder and due to the extensive adhesions in the area of the intestine, Dr. Zaragoza stopped the procedure in order to retrieve a CT scan of the area and personally evaluate the images. In order to expedite receipt of the CT study, Dr. Zaragoza scrubbed out and personally walked to the radiology suite. After returning, Dr. Zaragoza read the CT scan and the radiologist’s interpretation, which indicated that the gallbladder was posterior to the transverse colon. Dr. Zaragoza returned to Patient J.C., mobilized the colon to free it from the liver and attempted to locate the gallbladder behind the colon where he expected it to be. What Dr. Zaragoza found behind the transverse colon was a dark, thickened, and solid structure in the anatomical position which the CT scan and radiologist report suggested the gallbladder would be located. While the gallbladder, which consists of a water sac, is normally soft, pink, and pliable, this is not the case with an inflamed and infected one. Given Patient J.C.’s history of chronic cholecystitis with an acute cholecystitis secondary to the blockage of bile ducts by gallstones, Dr. Zaragoza was expecting to find a dark, thickened, and solid gallbladder in Patient J.C. Concluding that the structure he had located was the gallbladder, Dr. Zaragoza freed the organ of surrounding tissue, freeing away without incision adhesions to the organ, bringing the organ into position for removal. As Dr. Zaragoza began to free up the fat tissue around what he believed were the bile duct and blood vessels of the gallbladder, the organ ruptured, revealing a solid mass. Dr. Zaragoza believed that the mass was a tumor, which Dr. Zaragoza had encountered in other gallbladder surgeries. Dr. Zaragoza continued the procedure, separating the gallbladder for removal. While dividing what he believed was a cystic duct, Dr. Zaragoza encountered a bifurcation that did not correspond to the anatomy of the gallbladder. At this point, Dr. Zaragoza decided that surgery needed to be converted from laparoscopic to an open procedure. After doing so, a frozen section of the organ was sent to pathology for evaluation, in order to obtain a rapid evaluation of the tissue. The pathology report revealed that the organ that Dr. Zaragoza had removed from Patient J.C. was a healthy kidney. Dr. Zaragoza thereupon located the gallbladder by examining the dense adhesions around the colon, a risky procedure. Ultimately Dr. Zaragoza was required to cut into the transverse colon where he located the gallbladder, which had eroded into the transverse colon. Dr. Zaragoza then completed the surgical procedure, removing the gallbladder. Patient J.C.’s family was immediately advised of what had taken place; that Dr. Zaragoza had removed a kidney, in addition to successfully removing the gallbladder. The removal of a healthy kidney involves a medical procedure totally unrelated to removal of an unhealthy gallbladder. Removal of a healthy kidney is not a known or expected complication of gallbladder removal. Dr. Zaragoza’s removal of Patient J.C.’s kidney during gallbladder surgery constituted a “a wrong-site procedure, wrong procedure, or an unauthorized procedure, or a procedure that is medically unnecessary or otherwise unrelated to the patient’s diagnosis or medical condition.” The Department’s proposed findings of fact 12 through 20 contained in the Department’s Proposed Recommended Order, are accurate, support the ultimate findings of fact made in this paragraph and are subordinate thereto. Proposed findings of fact 36 through 38 of Respondent’s Proposed Order in large part accurately reflect the difficulty of the surgery performed on Patient J.C. Even the Department’s own expert noted that he thanked God Patient J.C. had not been his patient. The suggestion in paragraph 26 that the removal of the kidney was “simply an unwanted complication associated with this cholecystectomy procedure” is, however, not supported by the weight of the evidence.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered by the Board of Medicine finding that Bernard J. Zaragoza, M.D., has violated Section 456.072(1)(bb), Florida Statutes, as alleged in the Administrative Complaint; imposing a fine of $5,000.00; issuing a letter of concern; requiring the completion of five hours of risk management education; and requiring that he perform 50 hours of community service. DONE AND ENTERED this 6th day of April, 2010, in Tallahassee, Leon County, Florida. LARRY J. SARTIN 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 6th day of April, 2010. COPIES FURNISHED: Rolando A. Diaz, Esquire Kubicki & Draper 25 West Flagler Street, Penthouse Miami, Florida 33130 Robert A. Milne, Esquire Department of Health Prosecution Services Unit 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399 Diane K. Kiesling, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-3265 Dr. Ana M. Viamonte Ros, Secretary Department of Health 4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
The Issue Whether Respondent medical physician violated Subsection 458.331(1)(t), Florida Statutes, by failing 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; Subsection 458.331(1)(m), Florida Statutes, by failing to keep medical records to justify the course of treatment of a patient; and/or Subsection 458.33(1)(p), Florida Statutes, by performing surgery at the spinal level of C6-7 without patient consent and without statutory exception.
Findings Of Fact Petitioner, through the Board of Medicine, is the state agency which licenses and has regulatory jurisdiction of medical physicians. At all times material, Respondent has been a licensed medical physician in the state of Florida, having been issued license No. ME 0017399. He is board-certified in orthopedic surgery, is a member of many spine-specialized medical societies, and is highly published in the field of spinal surgery. He has devoted 100 percent of his practice to spinal surgery since 1989. On or about August 16, 1991, Patient R.L., then a thirty-two-year-old woman, was referred to Respondent with complaints of neck and shoulder pain due to a work-related accident. On August 16, 1991, Respondent diagnosed R.L. as having cervical spondylosis with radiculopathy, and thoracolumbar scoliosis. He recommended she undergo magnetic resonance imaging (MRI) of her cervical spine at North Florida Regional Medical Center (NFRMC). R.L. underwent MRI of her cervical spine at NFRMC on September 20, 1991. The radiologist's report of R.L.'s September 20, 1991, MRI indicated no disc herniation, central stenosis, or foraminal impingement at the C3-4 and C4-5 disc levels or at the C6-7 and C7-T1 levels. The radiologist's report did indicate that at the C5-6 level there was a small abnormal posterior protrusion of disc material, centrally and slightly eccentric towards the right side and that axial images demonstrated a small, right-sided central/right paracentral herniation. The report added that a very mild and early uncontrovertral spurring was noted at this level but was not resulting in impingement for exiting nerve roots. R.L. next saw Respondent on September 24, 1991. On that date, Respondent reviewed R.L.'s cervical spine MRI with her and diagnosed a probable small central and right paracentral herniation at the C5-6 level. Respondent was then of the opinion that the cervical spine MRI did not clearly delineate a disc herniation at R.L.'s C5-6 level. Respondent accordingly recommended that R.L. undergo a myelogram-CT scan. Respondent did not indicate to R.L. that he detected any pathology at C6-7. On October 29, 1991, R.L. underwent a cervical myelogram and CT scan at NFRMC. The radiologist's report indicated an extradural defect at C5-6, which was moderate in size and touched the cord but which did not cause any cord compression. The report also stated that the nerve sleeved well and that there was a very slight posterior subluxaton of C5 on C6 associated with this. The report did not indicate any pathology at C6-7. R.L. next saw Respondent on November 14, 1991. On that date, Respondent reviewed R.L.'s cervical myelogram and CT scan with her, diagnosed a herniated nucleus pulposus at C5-6, and recommended C5-6 anterior cervical fusion with plates. Respondent did not, on that date, indicate to R.L. that he had identified any pathology at C6-7. R.L. testified that before surgery, Respondent did not tell her that he would be removing any disc other than the one at C5-6; that he did not indicate he thought R.L. would need more surgery than the surgery planned at C5-6; or that he might discover something during the planned surgery which would require the removal of any disc different than C5-6. Respondent testified that he did not recall whether he did or did not tell R.L. that C6-7 might some day require an operation or that C6-7 might need work while he was operating on C5-6. His office notes for January 21, 1992, only state She returns today for her preoperative visit. The nature and extent of her surgery has been explained to her and she voices understanding. R.L.'s and Respondent's testimony agree that before surgery, Respondent intended to remove and fuse only at C5-6; that R.L. understood and agreed that Respondent would remove only the disc at level C5-6 and fuse it; and that before surgery, neither of them expected Respondent to operate at a level of R.L.'s cervical spine different than C5-6. Experts for Petitioner and Respondent, (Drs. Gonzalez- Perez and Smith respectively), concurred that if Respondent discussed the proposed procedure, most common and potential risks and complications, and the potential course of rehabilitation with R.L., and if Respondent and R.L. then reached a mutual decision to operate, full disclosure and informed consent had occurred, regardless of whether a written consent form had been filled out and signed. On January 29, 1992, R.L. signed an NFRMC "Authorization for Surgical Treatment and/or Special Procedure" which provided: I, the undersigned, a patient in the below named hospital, hereby authorize Dr. Lowery (and whomever he may designate as his assistants) to administer such treatment as is necessary, and to perform the following operation: anterior cervical fusion and instruments with autolugus and/or bone bank bone and such additional operations or procedures as are considered therapeutic on the basis of findings during the course of said operation. I also consent to the administration of such anesthetics as are necessary with the exception of none. Any tissues or parts surgically removed may be disposed of by the hospital in accordance with accustomed practice. I hereby certify that I have read and fully understand the above AUTHORIZATION FOR SURGICAL TREATMENT, the reasons why the above-named surgery is considered necessary, its advantage and the possible complications, if any, as well as possible alternative modes of treatment, which were explained to me by Dr. Lowery. I also certify that no guarantee or assurance has been made as to the results that may be obtained (Underlined portions were written in; the remainder was pre-printed). The foregoing hospital authorization did not identify the level of the cervical spine where the procedure would be performed. It merely indicated that an anterior cervical fusion would be performed, without stating which of the seven vertebrae were intended to be fused. Dr. Gonzalez-Perez, Petitioner's expert witness, testified that this is not the type of release a reasonable and prudent physician would use for informed consent. Petitioner contends that Respondent's use of the authorization form deviated from the level of care, skill, and treatment recognized by a reasonable and prudent physician as being acceptable under similar facts and circumstances, but even Petitioner's expert, Dr. Gonzalez-Perez, testified that such a form is usually filled-out by a nurse employed by the hospital, and that if Respondent and R.L. went through an informed consent conversation prior to surgery, that would be sufficient, without a written acknowledgement or authorization, for Respondent to have met the standard of care for informed consent and patient pre-authorization for surgery at the mutually understood level of C5-6. On February 3, 1992, Respondent performed an anterior cervical fusion with plates on R.L. at NFRMC, with the intention of operating at the C5-6 level of R.L.'s cervical spine. In doing so, he utilized a portable fluoroscopy unit, intraoperatively, to ascertain the correct level of R.L.'s cervical spine for the anterior cervical fusion with plates. The success of such a procedure depends upon properly identifying the pathological discs. It is critical to correctly ascertain the site where the surgery is to be performed. Failure to correctly identify the location for surgery can result in a failure to perform the intended surgery, a failure to resolve the problem which required the surgery, and/or performing surgery in a location not requiring surgery. The method Respondent used was to palpate the boney structures, make an incision to the vertebral bodies, insert a single needle, take an X-ray, and see if the needle had correctly located where surgery should take place. Respondent's expert, Dr. Smith, and Respondent testified that they prefer the one-needle method utilized by Respondent. Dr. Gonzalez-Perez admitted that use of X-rays, including fluoroscopy in the operating room in order to locate the level of the operation is the "gold standard" of care in this type of orthopedic surgery. He would have used a two- needle technique for locating and checking the location of the surgical site, but even he considered the one-needle method to constitute acceptable medical practice. In R.L.'s case, Respondent placed the single needle at the C7-T1 level, and the fluoroscopic lateral spot films of R.L.'s cervical spine obtained in the operating room showed the needle at the C7-T1 level. Respondent, however, concluded incorrectly that the fluoroscopic lateral spot films showed a needle at the C6-7 level. Respondent miscounted from the vertebra landmark of what he thought was C-2, and removed and fused the wrong disc. On February 3, 1992, after drawing the conclusion that the intraoperative fluoroscopic lateral spot films showed a needle at the C6-7 level of R.L.'s cervical spine, Respondent proceeded with an anterior cervical fusion with plates at what he assumed was the C5-6 level of R.L.'s cervical spine, which, in fact, was the C6-7 level. Respondent, in fact, performed an anterior cervical fusion with plates at the C6-7 level of R.L.'s cervical spine. Respondent surmised in his testimony that he had been confused because on R.L., the C-2 and C-3 structures were very similar. Dr. Gonzalez-Perez maintained that Respondent should have been able to locate the correct level based on the jaw bone and part of the skull being visible in the first and pre-removal X-ray (lower image of P-7). Respondent disagreed that skull and jaw are the best landmarks. Dr. Smith testified that C-2 and C-3 look similar due to their scalloped edges, but either would be an appropriate point from which to begin counting. He, personally, would normally begin counting with C-2, which is a very distinctive- looking vertebra. He opined that even reasonable and prudent physicians can make mistakes in counting and removing the wrong disc. Dr. Gonzalez-Perez felt that Respondent could have and should have involved others in the operating room in counting vertebrae and selecting the surgical location. Respondent disagreed, maintaining that only the surgeon should make such a decision. Dr. Smith testified that he, personally, asks someone else in the operating room to check him after he has counted. Petitioner contends that by failing to correctly identify the level of the spine and to make certain of the operative level before proceeding, Respondent failed to practice with the level of care, skill and treatment which is recognized by a reasonable and prudent medical physician under similar facts and circumstances as being acceptable and that Respondent had the information and should have been able to properly and correctly count the levels of the cervical spine and find the appropriate disc. However, even Petitioner's expert, Dr. Gonzalez-Perez, testified that Respondent met the standard of care up to the point at which Respondent performed the actual operation, and that operating at an unintended level is a known complication of such surgery, as stated in the textbooks. Respondent testified that during the surgery, he found a disc fragment and a tear in the posterior longitudinal ligament (PLL) at the wrong level (C6-7) where he removed the wrong disc, and that during the surgery, he relied upon this discovery as indicative that he was operating at the correct location/level (C5-6). Respondent testified that he removed the piece of disc at C6-7 in one piece, found a rent in the PLL behind it, and believed the pathology he had found corresponded to what he had expected to find at the C5-6 level, based on his preoperative evaluation. Dr. Gonzalez-Perez testified that a rent in the PLL cannot be seen until the disc is removed, so viewing it does not verify the location at which a discectomy should occur. He also stated that although a surgeon tries not to push down, occasionally s/he must dig in and push tissue to the back so as to remove the desired tissue and that portions of the disc may remain in the disc space until they are scooped out. Therefore, the procedure itself can result in a tear of the PLL. In light of the pre-operative tests not showing disc material or a PLL tear, Petitioner urges that the conclusion be drawn that Respondent's surgery itself caused the tear and protrusion at R.L.'s C6-7 level, but Dr. Gonzalez-Perez did not clearly state such a conclusion. Dr. Smith testified that finding such pathology after beginning the disc removal would have been a comforting (re- enforcing) sign to any surgeon that s/he had operated at the correct level, but Dr. Smith acknowledged that such a sign would not identify the correct disc for removal before removal actually began. Due to the superiority of Respondent's and Dr. Smith's cervical spine surgical experience over that of Dr. Gonzalez- Perez, who does only an average of two cervical spine operations per year, and due to Respondent's explanation of how the PLL/annulus structures differ in the cervical spine from the lumbar spine, it is found that even if the Respondent did not see the disc fragment and PLL rent until after he began removal of the C6-7 disc, the pathology at C6-7 reasonably reinforced Respondent's belief that he was operating in the correct location of C5-6 for the duration of the operation. No one clearly testified that the C6-7 removal and fusion was necessary on February 3, 1992, or that it would become necessary at some later date. Likewise, no one clearly testified that the removal and fusion at C6-7 was not necessary on February 3, 1992, or would not have become necessary later. Dr. Smith testified that in his pre-operative discussions with his own patients, they usually tell him to fix any additional unexpected pathology he finds once he begins an operation. The evidence falls short of being clear and convincing that the wrong disc removal and fusion on February 3, 1992, resulted in any subsequent damage to R.L.'s spine. While still in the operating room, Respondent checked his work with a second fluoroscopic image (upper image of P-7). Respondent and both experts agreed that this second image would cause a surgeon who thought he had counted correctly to assume he had removed the correct disc and created a good fusion at the correct level. However, the two experts concurred that there were no clear landmarks whatsoever on this view to show that the operation had occurred at either the correct or the incorrect level. Respondent's operative report for the February 3, 1992, procedure incorrectly described removal of the C5-6 disc space. On February 4, 1992, postoperative X-rays taken at NFRMC showed that the anterior cervical fusion with plates had, in fact, been performed at the wrong level, C6-7, of R.L.'s cervical spine. Copies of the report concerning the X-rays were supplied to Respondent at about that time. About a week later, the radiologist's narrative to the same effect was provided to Respondent. Nonetheless, Respondent did not discover his error for nearly six months. After the surgery, R.L. continued to experience pain, presumably because she still had the same uncorrected, pre- operative problem at C5-6. R.L. returned to Respondent on an outpatient basis on February 11, 1992. On that date, Respondent performed a radiographic examination of R.L.'s cervical spine but made no mention to her that the anterior cervical fusion with plates had been performed at the wrong level. He made no such notation in her chart. Respondent told R.L. that he had looked at the X- rays and everything had gone well and everything looked good. R.L. next saw Respondent on March 12, 1992, when he again performed a radiographic examination of R.L.'s cervical spine. At that time, Respondent made no mention of the C6-7 level of the anterior cervical fusion with plates in her chart and again did not tell R.L. that he had removed the wrong disc and fused the wrong location. R.L. next saw Respondent on April 23, 1992, and again Respondent did not reveal his error to R.L., but he did make a narrative note to her chart which stated that R.L. "is now approximately eleven weeks from having an ACF, C6-7." Even so, Respondent did not discover he had operated on the incorrect level until R.L.'s July 23, 1992 visit, at which time, he informed R.L. what had occurred. Respondent's July 23, 1992, narrative note for R.L.'s chart makes the statement that I have explained that there is a discrepancy in her clinical exam and also the intraoperative findings and postoperative x- rays, both to the patient and her rehabilitation counselor, Ms. Terry L. Smith, R.N. Respondent clearly remembered the presence of the nurse on July 23, 1992.1 Dr. Gonzalez-Perez opined that Respondent's performance was acceptable up to the operation itself, but was not up to the acceptable level of care thereafter, because from the first (lower image P-7) fluoroscopy image, Respondent should have been able to tell the needle was on the wrong level by counting vertebrae; because Respondent should have involved others in the operating room in analyzing the X-ray; because Respondent should not have removed the C6-7 disc, based on his own preoperative work-up; and because Respondent should not have relied on the rent and fragmentation at C6-7 to confirm his conclusion that he was operating at the correct level/location. Dr. Gonzalez-Perez faulted Respondent's record-keeping for failing to write in a recommendation; because his records did not justify the removal and fusion at C6-7; and because Respondent did not follow his own initial surgical plan. Ultimately, however, Dr. Gonzalez-Perez testified that it is not "malpractice" to operate at the wrong level, provided the error is discovered at the end of the operation, because one may decide to re-operate correctly. Dr. Smith's opinion was that an acceptable level of care had been met if Respondent informed the patient of his error once he discovered it. There is no dispute that at the July 1992 office visit, Respondent offered to do the C5-6 surgery for R.L. immediately. Respondent has had no prior or subsequent disciplinary actions against him. This event occurred three years after he began to devote himself exclusively to spinal surgery. Eight years have passed since this event. There is no evidence of any other level of practice problem of any kind.
Recommendation Based upon the Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Board of Medicine enter a final order finding Respondent guilty of violating Subsections 458.331(1)(m),(p), and (t), Florida Statutes, with mitigating circumstances, reprimanding him for same, and imposing a $750.00 fine. DONE AND ENTERED this 28th day of December, 2000, in Tallahassee, Leon County, Florida. ELLA JANE P. DAVIS 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 28th day of December, 2000.
The Issue Whether respondent, a medical doctor, should have his license to practice medicine revoked or otherwise disciplined for alleged malpractice, unethical medical practices', and performance of services which he knew or should have known he was not competent to perform.
Findings Of Fact Respondent, George A. Chakmakis, M.D., is licensed by the Department to practice medicine in Florida. At all times material to this proceeding, he was engaged in the general practice of medicine at 123 Tampa Street, Auburndale, Florida., (P-6.) I. As to Count I Failure to Detect Clear Abnormality in Patient's Chest X-ray From 1974 to 1977, Mary Louise Wahl was respondent's patient. At various times, he treated her for rheumatoid arthritis, chronic bronchitis, and the flu. (P-8.) On .February 16, 1977, respondent had a chest x-ray taken of Ms. Wahl. In reading the x-ray film, he failed to detect or identify any abnormality in her lung. In a letter he subsequently wrote to another physician, respondent contended that, in February, 1977, her chest x-ray "was clear." (Testimony of Spanogle; P-5, P-8.) During the next eight months, Ms. Wahl suffered from chronic breathing problems. Respondent treated her for bronchitis and prescribed various antibiotics--none of which caused any noticeable improvement in her condition. Her last visit to respondent's office was on November 11, 1977. (P-8.) On December 15, 1977, Ms. Wahl was admitted to the emergency room of Winter Haven Hospital. She complained of progressive shortness of breath and coughing to Dr. Alan G. Gasner, the physician on duty. (P-8.) Dr. Gasner did a complete history, performed a physical examination and had a chest x-ray taken of Ms. Wahl. The x-ray revealed a massive left pleural effusion. He removed the fluid from the left side of her chest and conducted tests to determine the cause of the effusion. He concluded that she had a carcinoma of the lung, with metastic tumor as the cause of the left pleural effusion. She received chemotherapy and was discharged from the hospital 13 days later. (P-8.) On May 5, 1978, Ms. Wahl was readmitted to Winter Haven Hospital. Twelve days later, she died. The cause of death: metastatic carcinoma (or cancer) of the lung. (P-8.) The chest x-ray of Ms. Wahl, taken by respondent on February 16, 1977 clearly showed an abnormality in the upper left lobe of her lung. The abnormality, indicated by a white hazy area between the ribs, was obvious, not subtle: a physician who had completed medical training should have been able to recognize it. The white hazy area was present only on the left lobe, not the right. In examining lung x-rays, physicians are trained to compare the left side with the right side. Additional factors were present: Ms. Wahl was 63 years old and respondent was aware that she smoked cigarettes. Respondent's failure to detect such an obvious abnormality in the February 16, 1977, chest x- ray deviates from the standard of care, skill, and treatment recognized by reasonably prudent similar physicians as acceptable under similar circumstances. This standard of care, and respondent's deviation therefrom, was established at hearing by the expert testimony of five licensed physicians who practice medicine in the Auburndale-Winter Haven area. Respondent admitted, at hearing, that the February 16, 1977, chest x-ray shows an increased density in the left upper lobe of the lung. (Testimony of Chakmakis, Gasner, Libinski, Cottrell, Koon, Morgan; P-5.) The abnormality shown in the February 16, 1977, chest x-ray of Ms. Wahl, if detected, would have warranted further action by the treating physician, such as additional x-rays, including a lateral view, and tests. In light of Ms. Wahl's age and smoking habit, the February 16, 1977, x-ray would lead a prudent physician to suspect a malignancy or carcinoma. If it was a carcinoma, immediate action would have been necessary; it is possible that surgical intervention to remove the carcinoma could have been performed. (Testimony of Cottrell, Gasner, Lipinski, Koon, Morgan.) It cannot, however, be concluded that respondent's failure to detect the clear abnormality in Ms. Wahl's lung caused or contributed to her eventual death from carcinoma of the lung. No definite link has been established. There is no way of now knowing whether Ms. Wahl had a carcinoma or cancer in February, 1977. The abnormality shown in the x-ray could be consistent with these different primary diagnoses: cancer, tuberculosis, and pneumonia. (Tr. 50.) Failure to Provide Chest X-ray to Ms. Wahl's Subsequently Treating Physician When Ms. Wahl was admitted to Winter Haven Hospital in December, 1977, she explained to Dr. Gasner that she had been under the care and treatment of respondent. Dr. Gasner immediately asked respondent to forward her medical records so that he could determine the nature of her treatment. Respondent replied by letter dated December 21, 1977: he indicated that her last chest x- ray, taken February, 1977, was clear; that her last office visit was on November 11, 1977, when she was treated for bronchitis; and he enclosed copies of lab test results. On December 28, 1977, Dr. Gasner wrote respondent, explaining that he needed to have her prior chest x-ray films in order to plan a course of therapy for her. Dr. Gasner received no response from respondent. (P-8.) Respondent's failure to provide Dr. Gasner with the requested chest x- rays of Ms. Wahl is insufficient, in itself, to support a conclusion that respondent refused to supply such records. Respondent testified that he believed that the requested x-rays had been sent to Dr. Gasner; such testimony, although self-serving, was not refuted by the Department. It is concluded that respondent's failure to supply the x-rays requested by Dr. Gasner's December 28, 1977, letter was due to inadvertence, not willful refusal. (Testimony of Chakmakis.) Refusal to supply patient medical records requested by a subsequent treating physician constitutes a deviation from the accepted standard of care in the Auburndale-Winter Haven area. But, it has not been shown that the inadvertent failure to supply such records constitutes a deviation. (Testimony of Koon, Cottrell.) II. As to Count II Argola O'Neal was respondent's patient from November 8, 1978, through December 20, 1978. She went to him for treatment of kidney problems and recalls receiving two drug prescriptions from him. He also dispensed drugs to her in his office. (Testimony of O'Neal.) She has no complaints about the quality of the treatment she received. The medications respondent prescribed made her feel better. She stopped seeing respondent because her husband felt that respondent's prices were too high. (Testimony of O'Neal.) After leaving the care of respondent, Ms. O'Neal became a patient of Dr. William Cottrell. At Dr. Cottrell's request, she showed him the medications which had been prescribed by respondent. They included: Inderal, 40 milligram and 20 milligram tablets; Digoxin, .25 milligrams; Tofranil; Synthroid; Isomil; Dyazide; Serapes, 10 milligrams; Nitrostat; Lasix, 20 milligrams; Mylicon; Darvocet-N 100; Thyroid, 2-grain tablets; and Gaviscon. The Inderal prescriptions were duplicative, as were the drugs Synthroid and throid extract. If used improperly, they were potentially dangerous to the patient. (Testimony of Cottrell.) Ms. O'Neal, age 76, is a frail woman suffering from senility and hardening of the arteries. Her ability to accurately recall respondent's brief treatment of her--occurring three years prior to hearing--has been affected. For example, she did not recognize respondent until he introduced himself to her immediately before hearing. Her testimony conflicts with that of her husband, Fred O'Neal. He testified that she stopped seeing respondent because she was dissatisfied with his treatment. (Testimony of O'Neal, Cottrell.) Because Ms. O'Neal had medications prescribed by an earlier doctor, respondent was concerned about prescribing duplicate medications. He instructed her to stop taking duplicative diuretics, thyroid, and heart medications. Although Ms. O'Neal does not recall such instructions, respondent's recollection is persuasive. (Testimony of Chakmakis.) When Ms. O'Neal became Dr. Cottrell's patient, she expressed some confusion concerning the medications which she had received from respondent. Although Dr. Cottrell testified that, in his opinion, there was some redundancy in the medications prescribed by respondent, he consistently avoided concluding that the prescriptions were sufficiently excessive or inappropriate to constitute a deviation from the prevailing standard of medical care in the Auburndale-Winter Haven area. 2/ (Tr. 235-236.) In his treatment of Ms. O'Neal, Dr. Cottrell tried to simplify the medication instructions and make sure that her husband was fully aware of them. (Testimony of Cottrell.) III. As to Count III Ronald Sequino was respondent's patient from November 30, 1978, through December 11, 1978. On Friday, November 30, 1978, respondent surgically removed two cysts from Sequino's back. The agreed-upon price was $30. (Testimony of Sequino; P-2, P-6.) That evening, the cyst wounds began to open. Sequino, concerned about infection, telephoned respondent's office number Friday evening, Saturday, and Sunday. He obtained respondent's answering service which informed him that respondent was unavailable; he left a message for respondent to contact him. Respondent did not return Sequino's call. (Testimony of Sequino.) The next week, Sequino returned to respondent's office for treatment of the wound which, by then, was discharging pus. Sequino, disturbed by his inability to reach respondent during the weekend, asked respondent whether the answering service had contacted him; respondent replied that he had gotten the message from the answering service but "made light of it" by telling Sequino that he worried too much. (Testimony of Sequino.) During the weekend that Sequino tried unsuccessfully to reach him, respondent did not have another physician covering for him. Respondent's testimony to the contrary is rejected as selfserving and uncorroborated. Neither did respondent have hospital privileges. (Testimony of Davis, Sequino; P-6.) Sequino returned to respondent two more times for post-operative care. The healing of his cysts was aggravated because Sequino frequently got his back wet, contrary to respondent's instruction. Because of this, respondent charged Sequino an additional $12 for each follow-up visit. (Testimony of Davis.) Sequino was disturbed by what he perceived as respondent's lack of concern; he was also upset about being separately charged for each follow-up visit. He became angry, used threatening language toward respondent, and mumbled profanities on leaving the office. (Testimony of McGuire.) Respondent denies that he was unavailable or received an answering service message from Sequino during the weekend following the cyst removals. He denies that he made "light" of Sequino's concern about not being able to reach him. He asserts that if he was unavailable, he had another physician covering for him. These contentions are rejected as selfserving and lacking corroboration. Diane Davis, his former receptionist and clerk-secretary, testified that--to her knowledge--respondent had no physician cover for him when he was out of town; that, during the weekends when he was unavailable, he never referred a patient to another physician. (Testimony of Chakmakis, Davis.) By failing to provide continuing care to Sequino over the weekend, or making arrangements so that another physician would be available to provide such care, respondent deviated from the prevailing standard of medical care and treatment recognized by a reasonably prudent similar physician as acceptable under the circumstances. That standard of care requires that a physician be available to his patients or have a physician cover for him at all times. Similarly, contrary to the Principles of Medical Ethics, he neglected his patient after having undertaken to provide him medical care. Such a breach of medical ethics constitutes a deviation from the standard of medical care recognized by a prudent similar physician as acceptable under the circumstances. (Testimony of Morgan; P-7.) IV. As to Count IV Respondent admits having used the Bellew Vaccine Method for Treating Arthritis ("the Bellew Method"). He used it to treat the arthritis of Mary Wahl. The Bellew Method was developed by Bernard A. Bellew, M.D. Generally, it consists of regimen of intradermal and subcutaneous injections of commonly available influenza viral vaccines and respiratory bacterial vaccines. It purports to provide therapeutic or curative relief to arthritis. (Testimony of Chakmakis; P-1, P-8, P-16.) The Bellew Method is not widely known or used by the medical profession. Respondent does not know of another physician in the United States who uses it. (Testimony of Chakmakis; The Bellew Method is considered, at best, as an "unusual treatment" by other physicians the Auburndale-Winter Haven area. It is not accepted in that area, or elsewhere in the country, as an acceptable method for treating arthritis. It is so far removed from the accepted practice and method of treating arthritis that it cannot be considered to have even achieved experimental status. (Testimony of Cottrell; P-8.) Respondent's use of the Bellew Method to treat Ms. Wahl's arthritis deviated from the standard of care, skill, and treatment recognized by a reasonably prudent similar physician as acceptable under similar circumstances. (P-8.) No evidence was presented to show either that the Bellew Method has been proven effective or that it was harmful to Ms. Wahl. Neither was evidence presented to show that, before utilizing this method, respondent disclosed to Ms. Wahl that the Bellew Method had not been proven effective; that it was held in disfavor or not used by the mainstream of the medical community. No evidence was presented to show that Ms. Wahl gave her informed consent to such treatment after having been advised that, at best, it was considered to be unusual or unorthodox treatment by the medical community. V. Costs Incurred by Department in Obtaining Orders Compelling Discovery Respondent's failure to respond to discovery resulted in the Department filing numerous motions to compel. By orders dated July 15 and August 11, 1981, two such motions were granted and orders compelling discovery were issued. Respondent gave no excuse, or justification for his failure to respond to the Department's discovery. Accordingly, pursuant to Rules 1.380, Florida Rules of Civil Procedure, the Department was awarded reasonable expenses which it incurred in obtaining these orders. By stipulation, the Department's reasonable expenses were to be determined by affidavit of the Department's counsel submittal at final hearing. The affidavit indicates the Department incurred expenses in the amount of $419.16. (Affidavit of Expenses, dated August 13, 1981.)
Recommendation Based on the foregoing, it is RECOMMENDED: That the Board of Medical Examiners enter a final order suspending respondent's medical license for six (6) months, after which the suspension should be vacated upon: (1) a showing by respondent that he has satisfactorily completed an approved continuing education course on the proper administration, interpretation, and use of x-rays; and (2) respondent demonstrating, to the Board's satisfaction, that he recognizes the serious statutory, professional, and ethical obligations placed on a physician who administers experimental or unorthodox treatment to a patient. That the Board, as part of its final order, require respondent to pay $419.16 to the Department as reasonable expenses incurred in obtaining the orders compelling discovery dated July 15 and August 11, 19,81. DONE AND RECOMMENDED this 12th day of March, 1982, 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 12th day of March, 1982.
The Issue This is a license discipline case in which the Petitioner seeks to take disciplinary action against the Respondent on the basis of charges set forth in a three-count Administrative Complaint. The Administrative Complaint charges the Respondent with two violations of Section 458.331(1)(t), Florida Statutes, and one violation of Section 458.331(1)(m), Florida Statutes.
Findings Of Fact Background facts At all times material to this case, the Respondent, Rene A. Munecas, M.D., has been licensed to practice medicine in the State of Florida. Dr. Munecas is board-certified in Obstetrics. As of the date of the events from which the charges in this case arise, Dr. Munecas had practiced obstetrics for approximately 45 years. Dr. Munecas has practiced obstetrics in the State of Florida since 1970. Dr. Munecas was born in Cuba, and he attended medical school in that country. He graduated from the Havana University, School of Medicine, in 1950. He then did a two-year internship in obstetrics at the University Hospital, Havana, Cuba, followed by a two-year residency in obstetrics at the same hospital. Dr. Munecas practiced obstetrics in Cuba until 1961, at which time he moved to the United States. In this country he did a one-year rotating internship at the Highland Park General Hospital, Highland Park, Michigan, followed by a two-residency in obstetrics/gynecology (OB/GYN) at Jackson Memorial Hospital in Miami, Florida. He completed his OB/GYN residency training at Orange Memorial Hospital in Orlando, Florida. Upon completion of his residency training in this country, he practiced in Michigan until 1970, when he moved to Florida. During the many years Dr. Munecas has practiced in Florida, there has been only one prior instance of disciplinary action concerning his practice of medicine. 1/ The prior disciplinary proceeding did not arise from any misconduct by Dr. Munecas, but from concerns as to whether he was "unable to practice medicine with reasonable skill and safety to patients by reason of illness . . . or as a result of any mental or physical condition." 2/ By the time of the final hearing in the prior disciplinary proceeding, all of the medical experts were of the view that Dr. Munecas was able to practice with reasonable skill and safety so long as he continued to be monitored by his treating psychiatrist. The final order in that case (dated August 27, 1984) concluded as follows: ORDERED AND ADJUDGED that Respondent be placed on probation for a period of two (2) years during which time Respondent shall appear semi-annually before the Board and shall continue to be monitored by his treating psychiatrist, Dr. DeJesus who shall submit quarterly reports concerning Respondent to the Board during the two year probation period. No appearances by the treating psychiatrist, Dr. DeJesus, before the Board are required. Facts regarding patient A. B. There is very little evidence in the record of this proceeding concerning the quality or sufficiency of the written medical records kept by Dr. Munecas regarding his treatment of Patient A. B. 3/ There is no clear and convincing evidence that Dr. Munecas failed to keep written medical records justifying the course of treatment of patient A. B. Patient A. B., born July 4, 1965, was seen by Dr. Munecas on August 11, 1994, in the outpatient obstetrical clinic of Baptist Hospital of Miami. She was pregnant with twins. The hospital record indicates periodic visits to the clinic from August 11 through November 17, 1994. Her weight at the initial visit of August 11 was 210 pounds. She was 5 feet, 2 inches, tall. An outpatient ultrasound performed on November 3, 1994, indicated that both twins were in breech position. The results of that ultrasound were reported on November 4, 1994, and were known to Dr. Munecas prior to November 18, 1994, when another outpatient ultrasound was performed on patient A. B. At approximately 6:30 a.m. on November 19, 1994, patient A. B.'s membranes ruptured, and she was taken to the hospital. Dr. Munecas ordered an x-ray of the patient's abdomen for the purpose of ascertaining fetal position. An x-ray of A. B.'s abdomen was taken at about 8:15 a.m. For reasons not clear in the evidence in this case, a second x-ray of A. B.'s abdomen was taken about 10 minutes later. The two x-ray films did not provide any useful information about the position of either of the twins. A few minutes later, Dr. Munecas performed a pelvic examination of patient A. B., for the purpose of trying to determine the positions of the twins. On the basis of that examination Dr. Munecas was of the opinion that twin "A" was in a vertex position, and twin "B" was in a breech position. Later in the day, this opinion was shown to be incorrect. 4/ Dr. Munecas decided it was appropriate to deliver the twins vaginally, and began to take steps to implement that plan of treatment. Among other things, Dr. Munecas attempted to induce labor by administration of Pitocin, which induces labor by increasing uterine contractions. At approximately 5:00 p.m. on November 19, 1994, Dr. Munecas ordered a portable ultrasound examination of patient A. B.'s abdomen. 5/ The ultrasound examination was promptly performed, and by approximately 6:00 p.m. Dr. Munecas received the examination report. The report revealed that both twins were in a breech position. At some point after receiving the report of the ultrasound examination, Dr. Munecas changed his plan of treatment and decided that patient A. B. should be delivered by cesarean section. For reasons not clear from the record in this case, the cesarean section was not done until approximately 10:00 p.m. Twin "A" was delivered at 10:16 p.m., and twin "B" was delivered at 10:19 p.m. Both twins were healthy. Facts regarding current practice of obstetrics Ultrasound imaging is the procedure of choice for obtaining images to show fetal status. Ultrasound is superior to x-ray for such purposes for a number of reasons. Ultrasound produces fetal images that show more details than can be obtained by x-ray. The use of ultrasound also avoids certain potential fetal health risks that are associated with x-rays. Accordingly, except in the most unusual of circumstances, x-rays should not be used to obtain images of fetal status. Under the circumstances presented by patient A. B. on November 19, 1994, a reasonably prudent similar physician would have ordered an ultrasound. If for some reason an ultrasound was not available on the morning of November 19, 1994, a reasonably prudent similar physician would have relied on the results of the ultrasound that was performed on November 3, 1994. Pitocin is a drug that is commonly used by obstetricians to induce and enforce labor. The effect of Pitocin is to increase uterine contractions. Pitocin should only be used when it is desirable to induce labor. The obvious corollary is that Pitocin should never be administered to a patient in which vaginal delivery is contraindicated. Vaginal delivery was contraindicated for patient A. B. because of risks to fetal safety inherent in a situation when twins are both in a breech position. Those risks can be avoided by cesarean section delivery. In circumstances like those presented by patient A. B., with both twins in a breech position, a reasonably prudent similar physician would find it unacceptable to attempt a vaginal delivery. The only acceptable course of treatment under such circumstances would be a cesarean section. 6/ Therefore, it was a departure from standards of care, skill, and treatment acceptable to a reasonably prudent similar physician for Dr. Munecas to attempt to induce labor by patient A. B. Facts regarding patient M. E. Patient M. E., born November 28, 1963, was seen by Dr. Munecas on May 2, 1995, in the outpatient obstetrical clinic of Baptist Hospital of Miami. The hospital record indicates periodic visits to the clinic from May 2 through June 21, 1995. The record also indicates that lab tests had been performed prior to May 2. Dr. Munecas' note for the visit of June 2 indicates his belief that the fetus may have had intrauterine growth retardation. The visits of June 14 and June 21 indicate increases in patient M. E.'s systolic and diastolic blood pressure, and increased protein in her urinalysis. Pre-eclampsia is a term used to describe a form of pregnancy-induced hypertension. Symptoms of pre-eclampsia include elevated blood pressure, presence of protein in the urine and/or the presence of swelling or edema of the hands and feet. A patient exhibiting symptoms of severe pre-eclampsia is at risk for three circumstances of extreme urgency. One is the possibility of a brain hemorrhage, which can be fatal. Second is the possibility of heart failure and pulmonary edema. Third is the possibility of liver hemorrhage, which can cause the liver to swell and burst. This third possibility manifests itself by right upper quadrant abdominal pain. In the early morning hours of June 22, 1995, patient M. E. awoke with severe right upper quadrant abdominal pain. When the pain continued, she called Dr. Munecas at home and described her pain to him. Dr. Munecas instructed her to go to the hospital. At approximately 4:50 a.m. on June 22, 1995, patient M. E. arrived at the hospital. Her blood pressure was taken in the supine position and read 196/111. Patient M. E. complained of continuous severe right upper quadrant abdominal pain. Dr. Munecas was called at home and advised of the patient's status. At that time, Dr. Munecas gave no orders, but indicated his desire for a perinatal consultation. At about 5:00 a.m., the hospital nursing staff called Dr. Lai. Dr. Lai gave no orders, but said that Dr. Munecas should call him at home. Hospital nursing staff called Dr. Munecas a second time at approximately 5:15 a.m. They requested his presence at the hospital to evaluate the patient. At about 6:00 a.m. on June 22, 1995, the hospital nursing staff again called Dr. Munecas and again requested his presence at the hospital. At this time the nursing staff also requested that Dr. Munecas prescribe medication to lower the patient's blood pressure. Dr. Munecas did not prescribe any medications for the patient. Instead, he ordered that an abdominal ultrasound be performed on the patient immediately to see if the patient had gallbladder problems. The ultrasound was promptly performed. It did not reveal any gallbladder problems. At approximately 6:05 a.m., a nurse manager called Dr. Munecas at home, and again requested his presence at the hospital. Dr. Munecas thereupon embarked for the hospital. He arrived at approximately 7:00 a.m. He promptly examined the patient and found her cervix to be dilated up to 2 centimeters. Dr. Munecas' impressions following the examination included "severe pre-eclampsia." Following the examination of patient M. E., Dr. Munecas performed an amniotomy on the patient. Amniotomy is a technique for the induction of labor. It is accomplished by manual rupture of the patient's membranes. An amniotomy should only be performed when it is desirable to induce labor. The obvious corollary is that an amniotomy should never be performed on a patient in which vaginal delivery is contraindicated. Vaginal delivery was contraindicated for patient M. E. for two main reasons. First, following examination of patient M. E., it should have been obvious to any obstetrician that the patient was suffering from severe pre-eclampsia and that prompt action was necessary to minimize the risk of severe harm to the patient's health. Under the circumstances presented by patient M. E., on June 22, 1995, urgent delivery of the baby was the only acceptable course of patient treatment. Under the circumstances presented that day by patient M. E., there was no prospect for her to have an urgent vaginal delivery. A cesarean section was the only prospect for an urgent delivery of patient M. E. The second reason for which vaginal delivery was contraindicated for patient M. E., was the fact that the fetus appeared to have intrauterine growth retardation. Such a fetus is less able than a normal fetus to withstand the rigors of labor. Therefore, such a fetus is at greater risk for possible brain damage or death during vaginal delivery. Such risks are avoided by a cesarean section delivery. By inducing labor in patient M. E., Dr. Munecas exposed both patient M. E. and her fetus to unreasonable dangers which could be avoided by cesarean section delivery. A reasonably prudent similar physician faced with the circumstances presented by patient M. E. on June 22, 1995, would have gone to the hospital as quickly as possible following the first call from the hospital nursing staff describing the patient's status. Dr. Munecas' failure to do so was a departure from acceptable standards of treatment recognized by a reasonably prudent similar physician. A reasonably prudent similar physician faced with the circumstances presented by patient M. E. on June 22, 1995, in view of the obvious need for urgent relief of the severe pre- eclampsia, would have promptly made arrangements for a cesarean section delivery at the earliest possible time. Dr. Munecas' failure to do so was a departure from acceptable standards of treatment recognized by a reasonably prudent similar physician. Dr. Munecas appears to have voluntarily limited the scope of his medical practice since the incidents which gave rise to this proceeding. He limits his medical practice to gynecology and obstetrics in the office. He no longer performs major surgery or vaginal deliveries.
Recommendation On the basis of the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be issued in this case to the following effect: Dismissing Count Two of the Administrative Complaint; Concluding that the Respondent is guilty of having violated Section 458.331(1)(t), Florida Statutes, as charged in Count One of the Administrative Complaint and as charged in two of the three paragraphs of Count Three of the Administrative Complaint; and Imposing a penalty consisting of a permanent restriction on the scope of the Respondent's medical practice to the following extent: the Respondent is restricted from all hospital-based obstetrical practice and is barred from performing or assisting in the labor or delivery of any hospital obstetrical patient. DONE AND ENTERED this 10th day of February, 2000, in Tallahassee, Leon County, Florida. MICHAEL M. PARRISH 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 10th day of February, 2000.
Conclusions Sovereign immunity extends to “corporations primarily acting as instrumentalities . . . of the state, county, or municipalities.” See § 68.28(2), F.S.; Pagan v. Sarasota County Public Hospital Board, 884 So.2d 257 (Fla. 2d DCA 2004). MRHS was deemed to be an instrumentality of the hospital district by the Attorney General in an opinion dated December 8, 2006 and the circuit court in Marion County has reached the same conclusion in several cases. As a result, MRHS is entitled to sovereign immunity under § 768.28, F.S. The public policy basis for extending sovereign immunity to private entities such as MRHS has recently been questioned by two appellate courts. See University of Florida Board of Trustees v. Morris, 32 Fla. L. Weekly D1803 (Fla 2d DCA July 27, 2007) (Altenbernd, J., concurring), rev. denied, 2008 Fla LEXIS (Fla. Jan. 7, 2008); Andrews v. Shands at Lakeshore, Inc., 33 Fla. L. Weekly D30 (Fla 1st DCA Dec. 20, 2007). The nurses are employees of MRHS and they were acting within the scope of their employment when providing services to Tyler. As a result, the nurses’ negligence is attributable to MRHS. The nurses had a duty to provide competent medical care to Tyler. They breached this duty and violated the standards of care for nursing personnel by failing to report the cyanotic episodes to Dr. Pierre and by failing to properly perform the four-extremity blood pressure test. The nurses’ actions and inactions contributed to the delayed diagnosis of Tyler’s heart condition. However, Dr. Pierre’s failure to order an immediate cardiology consultation when she detected a heart murmur shortly after Tyler’s birth also contributed to the delayed diagnosis of Tyler’s heart condition. The delayed diagnosis of Tyler’s heart condition led to his “crash” on December 16 because it is more likely than not that Tyler would have been transferred to Shands or another tertiary facility had his condition been diagnosed sooner. Tyler was not a candidate for the second and third stages of the Norwood procedure because of the damage caused by the “crash,” and he also suffered brain damage during the “crash” that caused his developmental delay. The amount of damages agreed to by MRHS is reasonable, even though Dr. Pierre likely shares some of the responsibility for Tyler’s condition. Indeed, the life care plan prepared for Tyler reflects that the cost of a transplant is between $650,000 and $700,000 and Tyler is expected to require multiple transplants over the course of his life. Moreover, the non-economic damages (e.g., pain and suffering) of Tyler and his parents could very well have exceeded the settlement amount had the case gone to jury trial. LEGISLATIVE HISTORY: This is the first year that this claim has been presented to the Legislature. ATTORNEYS’ FEES AND LOBBYIST’S FEES: The claimants’ attorney provided an affidavit stating that that attorney’s fees will be capped at 25 percent of the amount awarded by the claim bill in accordance with §768.28(8), F.S. Lobbyist’s fees are not included in the 25 percent attorney’s fees. Lobbyist’s fees will be an additional 4 percent of the amount awarded by the claim bill, which would be $28,000 based upon the $700,000 claim. The Legislature is free to limit the fees and costs paid in connection with a claim bill as it sees fit. See Gamble v. Wells, 450 So. 2d 850 (Fla. 1984). The bill does so by stating that “[t]he total amount paid for attorney’s fees, lobbying fees, costs and other similar expenses relating to this claim may not exceed 25 percent of the amount awarded [by the bill].” If this language remains in the bill (and the bill is amended as recommended below to reflect the allocation approved by the circuit court), the claimants will receive a total of $525,000, with $393,750 going into Tyler’s special needs trust and $131,250 going to his parents. The remaining $175,000 will go to attorney’s fees, costs, and lobbyist’s fees. If this language was not in the bill (and the bill is amended as recommended below to reflect the allocation approved by the circuit court), the claimants would receive approximately $362,000, with approximately $271,500 going into Tyler’s special needs trust and approximately $90,500 going to his parents. The claimants’ attorney would receive a total of approximately $310,000 ($175,000 for attorney’s fees and approximately $135,000 for costs), and the lobbyist would receive $28,000. OTHER ISSUES: The bill identifies the Marion County Hospital District as the entity responsible for payment of the claim. The parties agree, and I recommend that the bill be amended to reflect MRHS as the entity responsible for payment because it is responsible for operating the hospital pursuant to a lease from the hospital district. The bill requires the entire claim to be paid into Tyler’s special needs trust. The parties agree, and I recommend that the bill be amended to require payment of the claim in accordance with the allocation approved by the circuit court, i.e., 75 percent into Tyler’s special needs trust and 25 percent to his parents. The bill requires any funds remaining in Tyler’s special needs trust upon his death to revert to the General Revenue Fund. The parties agree, and I recommend that the bill be amended to remove this language because the bill is being paid from the hospital’s funds, not State funds. The bill should be also amended to include the standard language requiring payment of Medicaid liens prior to disbursing any funds to the claimants. See § 409.910, F.S. RECOMMENDATIONS: For the reasons set forth above, I recommend that Senate Bill 68 (2008) be reported FAVORABLY, as amended. Respectfully submitted, cc: Senator Charlie Dean Representative Marcelo Llorente Faye Blanton, Secretary of the Senate T. Kent Wetherell Senate Special Master House Committee on Constitution and Civil Law Tony DePalma, House Special Master Counsel of Record
The Issue The issues are whether Respondent is guilty of violations of Section 458.331(1)(k), (m), and (t) in the practice of medicine and, if so, what penalty the Board of Medicine should impose.
Findings Of Fact Respondent is a licensed physician, holding license number ME 0033129. His license was originally issued on August 2, 1978, and remains current. There is no prior discipline against Respondent. Respondent has been certified for over 15 years by the American Board of Obstetrics and Gynecology. His practice has been devoted to obstetrics and gynecology. In 1990, Respondent was a member of a large group practicing obstetrics and gynecology in Cape Coral. Respondent was performing about 100 breast examinations a week. On the evening of April 10, 1990, D.W., who was 30 years old at the time, discovered a mass that felt like a marble in her right breast during a breast self-examination. She was upset and cried most of the night, fearful that she had breast cancer. Early the next morning, she made an appointment with Respondent's group for a breast examination later that day. A regular patient of another member of Respondent's group, who was unavailable on April 11, D. W. had last been seen by a member of Respondent's group on February 6, 1990, when her regular physician gave her an annual examination. Her breast examination at the time was normal. During the visit, the physician or nurse reviewed breast self-examination techniques with her. The physician started D. W. on birth control pills and directed her to return for a follow-up visit in two months. The April 11 office visit was devoted exclusively to addressing D. W.'s complaint of a lump in her breast. Respondent examined D. W.'s breasts with D. W. lying down and then sitting up. He felt nothing. While sitting up, D.W. guided Respondent's hand to the mass in the right breast. Still feeling nothing, Respondent remarked that the breast was somewhat fibrous. Respondent explained to D. W. that fibrocystic disease is something that women sometimes get in their breasts and it is nothing to worry about. In fact, at least 80 percent of all women in their 30s undergo fibrocystic changes in the breast. Respondent did not reach a specific diagnosis as a result of the April 11 office visit. The handwritten entries in Respondent's medical records--the complaint and blood pressure appearing to have been written by a nurse--read in their entirety: 4-11-90 Pt. c/o lump in R breast. BP--100/60 no mass found somewhat fibrous [Respondent's initials] Respondent did not advise D. W. to return to the office for a follow-up visit at a prescribed interval or if she detected the same mass or any changes in the mass. D. W. next visited Respondent's group on April 11, 1991, for her annual visit. She was seen by another physician in the group. D. W. told the physician of the lump in her breast and said that it was getting larger. The physician conducted a breast examination and felt a mass about two centimeters in diameter. Concerned about the mass, the physician scheduled an aspiration for diagnostic purposes. The results of the procedure disclosed severely atypical cells that were suspicious for carcinoma. The physician referred her to a surgeon, who first saw D.W. on May 2, 1991. The surgeon performed a breast biopsy on May 9. The biopsy revealed an infiltrating ductal carcinoma of the breast. Based on the biopsy findings, the surgeon conducted on May 17 a right modified radical mastectomy. The excised tumor measured 2.1 centimeters along its longest diameter. D. W. underwent chemotherapy and has had no recurrence of the cancer in the five years since the surgery. There are two sets of allegations concerning D.W.'s medical records. The first set of allegations is that Respondent fraudulently altered D. W.'s medical records. Someone in Respondent's office later typed the following addition to the records of D. W. immediately beneath the handwritten entry quoted above: D[.] came to the office today having felt a lump in her right breast. I could not feel anything, although her breast was somewhat fibrous. I told her to continue to check her breast and come back if she felt it again. [Respondent's initials/typist's initials-- {both typed}] Petitioner failed to prove that Respondent dictated or typed the note in the preceding paragraph or that he authorized the addition of this note to D.W.'s medical records. The intent in adding the note was fraudulent as to the third sentence, which is the only sentence in the note that is untrue. But Petitioner failed to prove that Respondent was in any way involved in the fraud. The second set of allegations concerning the medical records involves the adequacy of the records. Specifically, Petitioner alleges that Respondent failed to keep medical records justifying the course of treatment and violated the applicable standard of care by failing to keep adequate medical records. These allegations are best considered together with the remaining allegation, which is that Respondent violated the applicable standard of care by failing to recommend follow-up examinations and treatments for D. W.'s complaint of a lump in her breast. A violation of the applicable standard of care is the failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. The standard of care in this case pertains to the practice in early 1990. Petitioner nowhere alleges that Respondent violated the applicable standard of care by failing to detect the mass of which D.W. complained. Petitioner's expert witness, Dr. Harvey Gardy, conceded that such a failure would not necessarily violate the standard of care. Nor is it clear that the mass of which D.W. complained in April 1990 developed into the tumor removed from her breast a year later. The mass of which D. W. complained in April 1990 was in the three o'clock position, and the excised tumor was in the 12 o'clock position. Breast tumors do not change location, except to the extent that they grow, although patients conducting self- examinations may have difficulty locating the tumor with precision. Also, the excised tumor could have grown from an impalpable size in April 1990 to its size at the time of the mastectomy a year later. The second set of medical records allegations and the lone remaining standard of care allegation focus not on Respondent's alleged failure to detect and diagnose the mass of which D. W. complained, but on Respondent's alleged failure to respond adequately to D. W.'s complaint, even after he could not independently verify the mass. The applicable standard of care did not require Respondent to order further testing at the time to rule out a cancerous growth when he could not feel the mass. D. W. was not in a high-risk category for breast cancer based on her young age, three past pregnancies, and relevant family history. She displayed no physical signs of breast cancer. The physician conducting a breast examination is looking for a dominant or distinct mass--an isolated lump distinct from surrounding breast tissue. Respondent felt only fibrous changes. The applicable standard of care did not require that a physician order further diagnostic testing each time the physician detected a fibrous mass in a breast. Fibrous changes are not indicative of breast cancer. Petitioner has failed to prove that the applicable standard of care was any different when the patient claimed to have felt a distinct mass that the physician is unable to verify. It is more practical to direct a patient to return for a follow-up examination than to order potentially expensive tests. However, Petitioner failed to prove that the applicable standard of care required that a physician, failing to detect a mass in a patient not in a high-risk category for breast cancer, direct her to return to the office at a specified interval, such as two or three months later. Even less onerous than diagnostic testing or return office visits is the physician's direction that the patient return to the office if she feels the mass again or any changes in the mass. However, Petitioner failed to prove that the applicable standard of care required even this sensible precautionary direction from a physician. Testifying unpersuasively that the standard of care required the setting of a follow-up appointment, Dr. Gardy failed to testify at all whether the standard of care required Respondent to tell D. W. to return if she detected the mass again in a self-examination. One of Respondent's expert witnesses, Dr. Pierre Bouis, testified clearly on direct that the applicable standard of care did not require Respondent to direct D. W. to return if she felt the mass again (Tr. p. 125). On cross-examination, Dr. Bouis returned to the same issue and answered affirmatively the following, poorly worded question: Now, isn't it true that you also believe that it's an appropriate standard of care to tell a patient who presents under the same set of fact that she should keep checking herself and return if she feels it again or continue to feel it? Although there are many levels of care, there is a single applicable standard of care, which, if violated, justifies the imposition of discipline. By using "an," Petitioner's counsel suggested multiple standards of care and left open the possibility that the standard to which Dr. Bouis referred in his answer was aspirational, rather than mandatory. Respondent's other expert witness, Dr. J. Kell Williams, testified clearly that Respondent's failure to direct D. W. to return if she felt the lump again did not violate the applicable standard of care (Tr. pp. 43 and 52). Dr. Williams conceded that the better practice would have been to direct the patient to return (TR. pp. 43, 46, and 47), but he did not equate this practice with the applicable standard of care. In the absence of evidence establishing this sensible precaution as the applicable standard of care, Petitioner has failed to prove by clear and convincing evidence that the applicable standard of care required Respondent to advise D. W. that she should return to the office if she felt the mass again or any changes in the mass. The medical records are adequate for the limited purpose of the April 11 visit. They describe the findings and adequately outline Respondent's examination of D. W. They justify the course of treatment--which was effectively no treatment--for the reasons set forth in the preceding paragraphs. For the reasons set forth above, Petitioner has failed to prove by clear and convincing evidence the material allegations of the Administrative Complaint.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order dismissing the Administrative Complaint against Respondent. ENTERED on May 31, 1996, in Tallahassee, Florida. ROBERT E. MEALE, 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 on May 31, 1996. APPENDIX Rulings on Petitioner's Proposed Findings 1-3: adopted or adopted in substance, except she told him about the lump. Respondent never saw a lump. 4: adopted or adopted in substance, except that Respondent did not feel the marble-like mass that D. W. felt. Respondent felt only fibrocystic changes in the breast. 5-9 (second sentence): adopted or adopted in substance. 9 (remainder): rejected as irrelevant and recitation of testimony. 10-11 (second sentence): adopted or adopted in substance. 11 (remainder): rejected as irrelevant and recitation of testimony. 12-13 (first sentence): adopted or adopted in substance. 13 (remainder)-15: rejected as subordinate. 16 (first sentence): adopted or adopted in substance. 16 (second sentence)-17: rejected as recitation of evidence. 18: adopted or adopted in substance, as distinguished from the 2 cm tumor within the larger excised mass. 19: rejected as subordinate. 20: rejected as unsupported by the appropriate weight of the evidence. 21: rejected as irrelevant with respect to applicable standard of care. 22: rejected as unsupported by the appropriate weight of the evidence. The questions posed Dr. Bouis were ambiguous as to whether he was describing the better practice or the applicable standard of care. 23-24: rejected as irrelevant with respect to applicable standard of care. 25: rejected as subordinate and irrelevant. 26: rejected as subordinate. 27: rejected as unsupported by the appropriate weight of the evidence. 28: rejected as subordinate. 29-32: adopted or adopted in substance. 33: rejected as subordinate. 34: rejected as unsupported by the appropriate weight of the evidence. 35: rejected as subordinate. 36-38: rejected as subordinate and recitation of testimony. 39: rejected as unsupported by the appropriate weight of the evidence. 40: rejected as recitation of testimony. 41-43: rejected as unsupported by the appropriate weight of the evidence. 44-45: rejected as irrelevant. 46: adopted or adopted in substance. COPIES FURNISHED: Dr. Marm Harris, Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792 Jerome W. Hoffman, General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308-54034 Steven Rothenburg, Senior Attorney Agency for Health Care Administration 9325 Bay Plaza Boulevard, Suite 210 Tampa, Florida 33619 Bruce D. Lamb Shear Newman 201 East Kennedy Boulevard, Suite 1000 Tampa, Florida 33602
