The Issue The issues to be determined are whether Respondent violated the applicable standard of care in the practice of dentistry in violation of section 466.028(1), Florida Statutes, as alleged in the Administrative Complaints filed in each of the consolidated cases; and, if so, the appropriate penalty.
Findings Of Fact The Department of Health, Board of Dentistry, is the state agency charged with regulating the practice of dentistry in the state of Florida, pursuant to section 20.43, and chapters 456 and 466, Florida Statutes. Stipulated Facts Respondent is a licensed dentist in the state of Florida, having been issued license number DN14223 on or about December 1, 1995. Respondent’s address of record is 530 East Howard Street, Live Oak, Florida 32064. Respondent was licensed to practice dentistry in the state of Florida during all times relevant to the administrative complaints underlying this case. Patient T.C. was a patient of Respondent. Patient S.S. was a patient of Respondent. Patient G.H. was a patient of Respondent. Patient J.D. was a patient of Respondent. Patient J.A.D. was a patient of Respondent. Other Findings of Fact On July 23, 2004, Respondent entered into a Stipulation in Department Case No. 2002-25421 to resolve an Administrative Complaint which alleged violations of section 466.028(1)(m), (x), and (z). The Stipulation was adopted by a Final Order, dated January 31, 2005, which constitutes a first offense in these cases as to each of the sections cited. On September 21, 2007, the Department issued a Uniform Non-disciplinary Citation for an alleged violation of section 466.028(1)(n), related to the release of patient dental records. The Department offered no evidence of its disposition and, in any event, since these cases do not involve alleged violations of section 466.028(1)(n), the citation is of no consequence in establishing a penalty in these cases under Florida Administrative Code Rule 64B5-13.005(1). On January 19, 2017, the Department issued an Administrative Complaint in Case No. 2015-10804 for alleged violations of section 466.028(1)(m), (x), and (mm). The Department offered no evidence of its disposition of the Administrative Complaint and, as a result, the Administrative Complaint is of no consequence in establishing a penalty in these cases under rule 64B5-13.005(1). On January 19, 2017, the Department issued an Administrative Complaint in Case No. 2015-23828 for alleged violations of section 466.028(1)(m), (x), and (z). The Department offered no evidence of its disposition of the Administrative Complaint and, as a result, the Administrative Complaint is of no consequence in establishing a penalty in these cases under rule 64B5-13.005(1). Case No. 19-2898PL - The T.C. Administrative Complaint Patient T.C. was a patient of Respondent from June 14, 2011, to on or about August 12, 2013. During the period in question, Respondent owned Smile Designs, a dental practice with offices in Jacksonville, Lake City, and Live Oak, Florida. The Department, in the T.C. Administrative Complaint, recognized that “Respondent, along with an associate, [Dr. Morris], are . . . licensed dentists known to work at Respondent’s practice.” The Department’s expert witness, Dr. Brotman, was also aware that Dr. Morris practiced with Respondent. Patient T.C. suffered a stroke in 2009. During the period that she was seen by Respondent, she was in “decent health,” though she was on medication for her post-stroke symptoms, which included a slight problem with aphasia, though she was able to communicate. The stroke and the aphasia are neurological issues, not mental health issues. Patient T.C. was accompanied by her husband, L.C. during her visits to Respondent’s practice. He generally waited in the waiting area during Patient T.C.’s procedures though, as will be discussed herein, he was occasionally brought back to the treatment area. L.C. testified that he had never been advised that Patient T.C. experienced a seizure while under Respondent’s care, and had no recollection of having been told that Patient T.C. ever became unresponsive. Patient T.C. died in 2015. Count I Case No. 19-2898PL, Count I, charges Respondent with failing to immediately refer Patient T.C. to a medical professional or advise Patient T.C. to seek follow-up care for the management of what were believed to be seizures while Patient T.C. was in the dental chair. From Patient T.C.’s initial visit on June 14, 2011, through her visit on September 23, 2011, Patient T.C. was seen at Respondent’s practice on five occasions. Respondent testified that the office was aware of Patient T.C.’s history of seizures because the medical history taken at her first visit listed Diazapam, Levetiracetam, Diovan, and Lyrica as medications being taken by Patient T.C., all of which are seizure medications. Nonetheless, the dental records for the four visits prior to September 23, 2011, provide no indication that Patient T.C. suffered any seizure or period of non- responsiveness during those visits. On September 23, 2011, Patient T.C. presented at Smile Designs for final impressions for crowns on teeth 20, 21, 28, and 29. Respondent testified that she was not the treating dentist on that date. Patient T.C. was given topical anesthetics, and her pulse and blood pressure were checked. The treatment notes then provide, in pertinent part, the following: Patient had seizures on the dental chair - may be due to anxiety. Seizures last 2-3 minutes. No longer. After 30 minutes, patient was calm. Able to proceed with dental procedure . . . . During seizures pt. was responsive; she was able to respond to our commands. The medical records substantiate Respondent’s unrebutted testimony that she was not the treating dentist at the September 23, 2011, appointment. The June 14, July 19, and October 7, 2011, treatment notes made by Respondent all start with “Dr. Gerry,” and are in a notably different style and format from the September 23, 2011, treatment notes. The preponderance of the evidence establishes that Dr. Morris, and not Respondent, was the treating dentist when Patient T.C. experienced seizures on September 23, 2011. Much of Dr. Brotman’s testimony as to Respondent’s violation of a standard of care was based on his interpretation that, since the September 23, 2011, notes did not specifically identify the treating dentist (as did the other treatment notes described above), the notes must be presumed to be those of the business owner. Neither Dr. Brotman nor the Department established a statutory or regulatory basis for such a presumption and, in any event, the evidence adduced at hearing clearly rebutted any such presumption. Dr. Brotman testified that if another dentist had been identified in the records as having performed the treatment on September 23, 2011, that may have changed his opinion. The evidence established that Dr. Morris performed the treatment on September 23, 2011. Thus, Dr. Brotman’s opinion that Respondent violated the applicable standard of care was effectively countered. The T.C. Administrative Complaint charged Respondent with failing to comply with the applicable standard of care on September 23, 2011. The Department failed to establish that Respondent was the treating dentist on September 23, 2011, and, in fact, a preponderance of the evidence demonstrated that she was not. Thus, the Department failed to establish that Respondent violated the standard of care for failing to refer Patient T.C. to an appropriate medical professional for her seizures as alleged in Count I of the T.C. Administrative Complaint. Count II Case No. 19-2898PL, Count II, charges Respondent with delegating the task of intraoral repair of Patient T.C.’s partial denture to a person not qualified by training, experience, or licensure to perform such intraoral repair. July 17, 2012 Repair On July 17, 2012, Patient T.C. presented to Respondent because her lower partial denture was broken and the O-ring was out. The device included a female end within Patient T.C.’s jaw, and a male end with a plastic “gasket” on the denture. Respondent testified that the repair of the partial denture was performed outside of Patient T.C.’s mouth. Then, at the next scheduled visit, the treatment plan was for Respondent to “eval/repair partial denture on lower arch.” Respondent offered unrebutted testimony that “Tia of precision attachments” performed no work in Patient T.C.’s mouth. Dr. Brotman testified that, in his opinion, any repair of a precision attachment must be done by placing the attachment in the patient’s mouth to align with the teeth. However, Dr. Brotman did not know what kind of repair was done on July 17, 2012. He indicated that if a gasket or housing is missing, it can be repaired with an acrylic. Dr. Brotman testified that if acrylic was placed in the denture outside of the patient’s mouth, it would not be a violation of Florida law. The Department failed to prove, by clear and convincing evidence, that Respondent delegated the task of adjusting or performing an intraoral repair of Patient T.C.’s partial denture to “Tia” or any other unlicensed person on July 17, 2012, as alleged in Count II of the T.C. Administrative Complaint. June 11, 2013 Repair On June 11, 2013, Patient T.C. presented to Respondent for an evaluation of her lower precision partial denture. Patient T.C. complained that the partial denture did not have the metal housing to connect it with the bridges to its sides. Patient T.C. was a “bruxer,” i.e. she ground her teeth, and had worn out the denture’s metal attachment. Respondent evaluated the situation, and decided to attempt a chairside repair or replacement of the denture’s male attachments. If the chairside repair was unsuccessful, a complete new partial denture would have to be prepared by a dental laboratory. Respondent attempted the chairside repair. Respondent testified that she instructed her dental assistant to add acrylic into the slot where the male attachment was to be placed in the denture. There was no evidence of any kind to suggest that the dental assistant then placed the denture into Patient T.C’s mouth. Because too much acrylic was placed in the denture, it became stuck in Patient T.C.’s mouth. Patient T.C. became understandably upset. Her husband, L.C., was brought into the room, Patient T.C. was administered local anesthesia, and the precision partial denture was removed. Respondent’s testimony regarding the incident was generally consistent with her prior written statement offered in evidence. Dr. Brotman testified that making repairs to a precision denture must be performed by a licensed dentist, except for placing acrylic into the denture outside of the patient’s mouth, which may be done by a non-dentist. The evidence was insufficient to demonstrate that Respondent’s dental assistant did anything more than place acrylic into the denture outside of Patient T.C.’s mouth. The Department failed to prove, by clear and convincing evidence, that Respondent delegated the task of adjusting or performing an intraoral repair of Patient T.C.’s partial denture to her dental assistant on June 11, 2013, as alleged in Count II of the T.C. Administrative Complaint. Case No. 19-2899PL - The S.S. Administrative Complaint Count I Case No. 19-2899PL, Count I, charges Respondent with violating section 466.028(1)(m) by: Failing to keep a written record of Patient S.S.’s medical history; and/or Failing to keep an accurate written record of any consent forms signed by Patient S.S. Count II Case No. 19-2899PL, Count II, charges Respondent with violating section 466.028(1)(x) by: Failing to adequately diagnose decay in tooth 30; Failing to adequately diagnose the condition of the roots of tooth 30; Failing to adequately obturate the canals of tooth 30 during root canal treatment; Failing to adequately obturate the canals of tooth 31 during root canal treatment; Failing to take a new crown impression of tooth 31 following changes to the tooth’s margins; and/or Failing to adequately assess and correct the crown on tooth 31 when the fit was compromised. On May 15, 2014, Patient S.S. presented to Respondent for a root canal and crown on tooth 30. Upon examination, Respondent advised Patient S.S. that she also needed a root canal and a crown on tooth 31. Patient S.S. denied that she was required to provide her medical history at the May 15, 2014, office visit, or that she was provided with an informed consent form prior to the root canal on tooth 30. Respondent’s records do not include either a medical history or an informed consent form. However, the records, which were offered as a joint exhibit, were not accompanied by a Certificate of Completeness of Patient Records, including the number of pages provided pursuant to Respondent’s investigatory subpoena, as is routine in cases of this sort, and which was provided with the records of the subsequent dentists involved in Patient S.S.’s care. Many of the records offered in these consolidated cases, including Respondent’s licensure file, include the certification attesting to their completeness. The records for Patient S.S. do not. Petitioner elicited no testimony from Respondent establishing the completeness of the records. The records offered were, by appearance, not complete. Respondent indicated that medical history and consent forms were obtained. Entries in the records introduced in evidence indicate “[m]edical history reviewed with patient” or the like. Entries for May 16, 2014, provide that “[c]rown consent explained and signed by patient” and “root canal consent explained and signed by patient.” The record for June 4, 2014, indicates that “[r]oot canal consent form explained to and signed by patient.” Patient S.S. testified that she had no recollection of having filled out a medical history, or of having signed consent forms after having Respondent’s recommended course of treatment explained to her. However, Patient S.S.’s memory was not clear regarding various aspects of her experience with Respondent and with subsequent providers. Much of her testimony was taken from notes she brought to the hearing, and some was even based on what she read in the Administrative Complaint. Her testimony failed to clearly and convincingly establish that Respondent failed to collect her medical history or consent to treatment. Respondent testified that, at the time Patient S.S. was being seen, her office was in the midst of switching its recordkeeping software and converting records to digital format. The new company botched the transition, and by the time the issue was discovered, many of the records being converted to digital format were lost, in whole or in part. Respondent surmised that, to the extent the records were not in her files provided to the Department, that they were affected by the transition. The greater weight of the evidence suggests that medical history and signed consent forms were provided. Given the issues regarding the records as described by Respondent, and given the Department’s failure to produce a certification or other evidence that the records it was relying on to prove the violation were complete, the Department failed to meet its burden to prove, by clear and convincing evidence, that Respondent failed to keep a written record of Patient S.S.’s medical history and signed consent forms. Respondent also testified that the office notes were supplemented with handwritten notations made when a patient returned for a subsequent appointment. Several of Patient S.S.’s printed records carried handwritten notes. Respondent testified that those notes were made at some time in 2014 after Patient S.S.’s first office visit up to the time of her last visit, and were based on further discussion with Patient S.S. However, those records, Joint Exhibit 2, pages 1 through 17, bear either a date or a “print” date of March 12, 2015. Dr. Brotman testified that he knew of no software on the market that would allow contemporaneous handwriting on electronic records. Thus, the evidence is compelling that the handwritten notes were made on or after the March 12, 2015, date on which the records were printed, well after Patient S.S.’s last office visit. A root canal involves removing a tooth’s pulp chamber and nerves from the root canals. The root canals are smoothed out and scraped with a file to help find and remove debris. The canals are widened using sequentially larger files to ensure that bacteria and debris is removed. Once the debris is removed, an inert material (such as gutta percha) is placed into the canals. A “core” is placed on top of the gutta percha, and a crown is placed on top of the core. The risk of reinfection from bacteria entering from the bottom of an underfilled tooth is significantly greater than if the tooth is filled to the apex of the root. Patient S.S. returned to Respondent’s office on May 16, 2014, for the root canal on tooth 30 and crown preparations for teeth 30 and 31, which included bite impressions. Temporary crowns were placed. Respondent’s printed clinical notes for May 16, 2014, gave no indication of any obstruction of the canals, providing only the lengths of the two mesial and two distal root canals. Respondent’s hand-written notes for May 16, 2014 (which, as previously explained, could have been made no earlier than March 12, 2015), stated that the canals were “[s]ealed to as far as the canal is open. The roots are calcification.” Dr. Brotman indicated that the x-rays taken on May 15, 2014, showed evidence of calcification of the roots. However, Dr. Brotman convincingly testified that the x-rays taken during the root canal show working-length files extending to near the apices of the roots. Thus, in his opinion, the canals were sufficiently open to allow for the use of liquid materials to soften the tooth, and larger files to create space to allow for the canals to be filled and sealed to their full lengths. His testimony in that regard is credited. Patient S.S. began having pain after the root canal on tooth 30 and communicated this to Respondent. On June 5, 2014, Patient S.S. presented to Respondent to have the crowns seated for teeth 30 and 31. Patient S.S. complained of sensitivity in tooth 31. The temporary crowns were removed, and tooth 31 was seen to have exhibited a change in color. The area was probed, which caused a reaction from Patient S.S. Respondent examined the tooth, and noted the presence of soft dentin. A root canal of tooth 31 was recommended and performed, which included removal of the decay in the tooth’s dentin at the exterior of the tooth. Respondent’s removal of decay changed the shape of tooth 31, and would have changed the fit of the crown, which was made based on the May 16, 2014, impressions. There were no new impressions for a permanent crown taken for tooth 31 after removal of the decayed dentin. Respondent testified that she could simply retrofill the affected area with a flowable composite, which she believed would be sufficient to allow for an acceptable fit without making new bite impressions and ordering a new crown. There was no persuasive evidence that such would meet the relevant standard of performance. Temporary crowns were placed on teeth 30 and 31, and placement of the permanent crowns was postponed until the next appointment. Upon completion of the tooth 31 root canal on June 5, 2014, x-rays were taken of the work completed on teeth 30 and 31. Dr. Brotman testified that the accepted standard of care for root canal therapy is to have the root canal fillings come as close to the apex of the tooth as possible without extending past the apex, generally to within one millimeter, and no more than two millimeters of the apex. His examination of the x-rays taken in conjunction with Respondent’s treatment of Patient S.S. revealed a void in the filling of the middle of the distal canal of tooth 31, an underfill of approximately five millimeters in the mesial canal of tooth 31, an underfill of approximately four millimeters in the distal canal of tooth 30, and an underfill of approximately six millimeters in the two mesial root canals of tooth 30. The x-ray images also revealed remaining decay along the mesiobuccal aspect of the temporary crown placed on tooth 31. His testimony that the x-ray images were sufficiently clear to provide support for his opinions was persuasive, and was supported by the images themselves. A day after the placement of the temporary crowns, they came off while Patient S.S. was having dinner in Gainesville. She was seen by Dr. Abolverdi, a dentist in Gainesville. Dr. Abolverdi cleaned the teeth, took an x-ray, and re-cemented the temporary crowns in place. Patient S.S. next presented to Respondent on June 10, 2014. Both of Patient S.S.’s permanent crowns were seated. The permanent crown for tooth 31 was seated without a new impression or new crown being made. Patient S.S. was subsequently referred by her dentist, Dr. James Powell, to be seen by an endodontist to address the issues she was having with her teeth. She was then seen and treated by Dr. John Sullivan on July 25, 2014, and by Dr. Thomas Currie on July 29, 2014, both of whom were endodontists practicing with St. Johns Endodontics. As to the pain being experienced by Patient S.S., Dr. Sullivan concluded that it was from her masseter muscle, which is consistent with Respondent’s testimony that Patient S.S. was a “bruxer,” meaning that she ground her teeth. Dr. Sullivan also identified an open margin with the tooth 31 crown. His clinical assessment was consistent with the testimony of Dr. Brotman. The evidence was clear and convincing that the defect in the tooth 31 permanent crown was an open margin, and not a “ledge” as stated by Respondent. The evidence was equally clear and convincing that the open margin was the result of performing a “retrofill” of the altered tooth, rather than taking new bite impressions to ensure a correct fit. As a result of the foregoing, Respondent violated the accepted standard of performance by failing to take a new crown impression of tooth 31 following the removal of dentin on June 4, 2014, and by failing to assess and correct the open margin on the tooth 31 crown. Radiographs taken on July 25, 2014, confirmed that canals in teeth 30 and 31 were underfilled, as discussed above, and that there was a canal in tooth 31 that had been missed altogether. On July 29, 2014, Dr. Currie re-treated the root canal for tooth 31, refilled the two previously treated canals, and treated and filled the previously untreated canal in tooth 31. The evidence, though disputed, was nonetheless clear and convincing that Respondent failed to meet the standard of performance in the root canal procedures for Patient S.S.’s teeth 30 and 31, by failing to adequately diagnose and respond to the condition of the roots of tooth 30; failing to adequately fill the canals of tooth 30 despite being able to insert working-length files beyond the area of calcification to near the apices of the roots; and failing to adequately fill the canals of tooth 31 during root canal treatment. The Administrative Complaint also alleged that Respondent failed to adequately diagnose decay in tooth 30. The evidence was not clear and convincing that Respondent failed to adequately diagnose decay in tooth 30. Case No. 19-2900PL - The G.H. Administrative Complaint Case No. 19-2900PL charges Respondent with violating section 466.028(1)(x) by failing to adequately diagnose issues with the crown on tooth 13 and provide appropriate corrective treatment. On May 15, 2014, Patient G.H. presented to Respondent with a complaint that she had been feeling discomfort on the upper left of her teeth that was increasingly noticeable. Respondent diagnosed the need for a root canal of tooth 13. Patient G.H. agreed to the treatment, and Respondent performed the root canal at this same visit. Patient G.H. also had work done on other teeth to address “minor areas of decay.” On July 7, 2014, Patient G.H.’s permanent crowns were seated onto teeth 8, 9, and 13, and onlay/inlays placed on teeth 12 and 14. On July 29, 2014, Patient G.H. presented to Respondent. Respondent’s records indicate that Patient G.H. complained that when she flossed around tooth 13, she was getting “a funny taste” in her mouth. Patient G.H.’s written complaint and her testimony indicate that she also advised Respondent that her floss was “tearing,” and that she continued to experience “pressure and discomfort” or “some pain.” Respondent denied having been advised of either of those complaints. Respondent flossed the area of concern, and smelled the floss to see if it had a bad smell. Respondent denied smelling anything more than typical mouth odor, with which Patient G.H. vigorously disagreed. Respondent took a radiograph of teeth 11 through 15, which included tooth 13 and the crown. The evidence is persuasive that the radiograph image revealed that the margin between tooth 13 and the crown was open. An open margin can act as a trap for food particles, and significantly increases the risk for recurrent decay in the tooth. Respondent adjusted the crown on tooth 9, but advised Patient G.H. that there was nothing wrong with the crown on tooth 13. She offered to prescribe a rinse for the smell, but generally told Patient G.H. that there were no complications. Patient G.H. began to cry and, when Respondent left the room, got up from the chair and left the office. Respondent indicated in her testimony that she would have performed additional investigation had Patient G.H. not left. The contemporaneous records do not substantiate that testimony. Furthermore, Respondent did not contact Patient G.H. to discuss further treatment after having had a full opportunity to review the radiograph image. On March 10, 2015, after her newly-active dental insurance allowed her to see a different in-network provider, Patient G.H. sought a second opinion from Dr. Ada Y. Parra, a dentist at Premier Dental in Gainesville, Florida. Dr. Parra identified an open distal margin at tooth 13 with an overhang. Dr. Parra recommended that Patient G.H. return to Respondent’s practice before further work by Premier Dental. Patient G.H. called Respondent’s office for an appointment, and was scheduled to see Dr. Lindsay Kulczynski, who was practicing as a dentist in Respondent’s Lake City, Florida, office. Patient G.H. was seen by Dr. Kulczynski on March 19, 2015. Upon examination, Dr. Kulczynski agreed that the crown for tooth 13 “must be redone” due to, among other defects, “[d]istal lingual over hang [and] open margin.” The open margin was consistent with Patient G.H.’s earlier complaints of discomfort, floss tearing, and bad odor coming from that tooth. The evidence was persuasive that further treatment of Patient G.H. was not authorized by Respondent after the appointment with Dr. Kulczynski. Dr. Brotman credibly testified that the standard of care in crown placement allows for a space between the tooth and the crown of between 30 and 60 microns. Dr. Brotman was able to clearly identify the open margin on the radiograph taken during Patient G.H.’s July 29, 2014, appointment, and credibly testified that the space was closer to 3,000 microns than the 30 to 60 microns range acceptable under the standard of performance. His testimony is accepted. An open margin of this size is below the minimum standard of performance. The evidence was clear and convincing that Respondent fell below the applicable standard of performance in her treatment of Patient G.H., by seating a crown containing an open margin and by failing to perform appropriate corrective treatment after having sufficient evidence of the deficiencies. Case No. 19-2901PL - The J.D. Amended Administrative Complaint Case No. 19-2901PL charges Respondent with violating section 466.028(1)(x) by: Failing to obtain sufficient radiographic imaging showing Patient J.D.’s sinus anatomy, extent of available bone support, and/or root locations; Failing to lift, or refer for lifting of, Patient J.D.’s sinus before placing an implant in the area of tooth 14; Failing to appropriately place the implant by attempting to place it into a curved root, which could not accommodate the implant; Failing to react appropriately to the sinking implant by trying to twist off the carrier instead of following the technique outlined in the implant’s manual; and/or Paying, or having paid on her behalf, an indemnity in the amount of $75,000 as a result of negligent conduct in her treatment of Patient J.D. Patient J.D. first presented to Respondent on June 28, 2014. At the time, Respondent was practicing with Dr. Jacobs, who owned the practice. Patient J.D. had been a patient of Dr. Jacobs for some time. Respondent examined Patient J.D. and discovered problems with tooth 14. Tooth 14 and tooth 15 appeared to have slid into the space occupied by a previously extracted tooth. As a result, tooth 14 was tipped and the root curved from moving into the space. Tooth 14 had been filled by Dr. Jacobs. However, by the time Respondent examined it, the tooth was not restorable, and exhibited 60 percent bone loss and class II (two millimeters of movement) mobility. Respondent discussed the issue with Patient J.D., and recommended extraction of the two teeth and replacement with a dental implant. Patient J.D. consented to the procedure and executed consent forms supplied and maintained by Dr. Jacobs. The teeth at issue were in the upper jaw. The upper jaw consists of softer bone than the lower jaw, is more vascular, and includes the floor of the nose and sinuses. The periapical radiographs taken of Patient J.D. showed that he had a “draped sinus,” described by Respondent as being where “the tooth is basically draped around the sinuses. It’s almost like they’re kind of one.” Prior to Patient J.D., Respondent had never placed an implant in a patient with a draped sinus. The x-rays also indicated that, as a result of the previous extraction of teeth and the subsequent movement of the remaining teeth, the roots of tooth 14 were tipped and curved. The evidence was persuasive that Respondent did not fail to obtain sufficient radiographic imaging showing Patient J.D.’s sinus anatomy, the extent of available bone support, and the configuration of the roots. Dr. Kinzler testified credibly that the pneumatized/draped sinus, the 60 percent bone loss around tooth 14, and the tipped and curved roots each constituted pre- operative red flags. Respondent extracted teeth 14 and 15. When she extracted the teeth, she observed four walls. She was also able to directly observe the floor of the sinus. She estimated the depth of the socket to be 12 millimeters. Sinus penetration is a potential complication of implant placement. Being able to see the sinus floor was an additional complicating factor for implant placement. Dr. Kinzler credibly testified that if Respondent was going to place an implant of the size she chose (see below), then the standard of care required her to first do a sinus lift before placing the implant. A sinus lift involves physically lifting the floor of a patient’s sinus. Once the sinus has been lifted, material typically consisting of granulated cortical bone is placed into the space created. Eventually, the bone forms a platform for new bone to form, into which an implant can be inserted. The evidence established that the standard of care for bone replacement materials is to place the material into the space, close the incision, and allow natural bone to form and ultimately provide a stable structure to affix an implant. The implant may then be mechanically affixed to the bone, and then biologically osseointegrate with the bone. In order to seal off Patient J.D.’s sinus, Respondent used Bond Bone, which she described as a fast-setting putty-like material that is designed to protect the floor of the sinus and provide a scaffold for bone to grow into. She did not use cortical bone, described as “silly sand,” to fill the space and provide separation from the sinus because she indicated that it can displace and get lost. Respondent’s goal was to place the implant so that it would extend just short of the Bond Bone and Patient J.D.’s sinus. She also intended to angle the implant towards the palate, where there was more available bone. Bond Bone and similar materials are relatively recent innovations. Dr. Fish was encouraged by the possibilities of the use of such materials, though he was not familiar with the Bond Bone brand. The evidence was clear and convincing that, although Bond Bone can set in a short period, and shows promise as an effective medium, it does not currently meet minimum standards of performance for bone replacement necessary for placement and immediate support of an implant. Bond Bone only decreases the depth of the socket. It does not raise the floor of the sinus. As such, the standard practice would be to use a shorter implant, or perform a sinus lift. Respondent was provided with an implant supplied by Dr. Jacobs. She had not previously used the type of implant provided. The implant was a tapered screw vent, 4.7 millimeters in diameter, tapering to 4.1 millimeters at the tip with a length of 11.5 millimeters. Respondent met with and received information from the manufacturer’s representative. She used a 3.2 millimeter drill to shape the hole, as the socket was already large enough for the implant. The 3.2 millimeter drill was not evidence that the receiving socket was 3.2 millimeters in diameter. Respondent then inserted the implant and its carrier apparatus into the hole. The implant did not follow the root, and had little bone on which to affix. The initial post-placement periapical radiograph showed “placement was not correct.” Despite Respondent’s intent, the implant was not angled, but was nearly vertical, in contrast with the angulation of the socket which was tipped at least 30 degrees. Given the amount of bone loss, and the other risk factors described herein, the risk of a sinus perforation, either by having the implant extend through the root opening or by a lateral perforation through one of the sides of the socket, was substantial. After adjusting the implant, Respondent went to remove the carrier. The carrier would not release, and the pressure exerted caused the implant to loosen and begin to sink through the Bond Bone. Dr. Kinzler testified credibly that, because of the mechanics of the implant used, had it been surrounded by bone, it would not have been possible for the implant to become loose. In his opinion, which is credited, the loosening of the implant was the result of the lack of bone to hold it in place. Respondent was so intent on removing the carrier that she was not paying attention to the implant. As a result, she screwed the implant through the Bond Bone and into Patient J.D.’s sinus. By the time she realized her error, the implant had sunk in to the point it was not readily retrievable. She was hesitant to reaffix the carrier “because [she] knew [she] had no support from the bone, that it was just a matter of air.” Nonetheless, she “stuck the carrier back in, but it would not go back in.” She then turned to get forceps or a hemostat but, by that time, the implant was irretrievably into Patient J.D.’s sinus. At the hearing, Respondent testified that she could have retrieved the implant but for Patient J.D. doing a “negative pressure sneeze” when the implant was already into the sinus. At that point, she stated that the implant disappeared into Patient J.D.’s sinus, where it can be seen in Petitioner’s Exhibit 9, page 35. There is nothing in Respondent’s dental records about Patient J.D. having sneezed. Respondent further testified that Patient J.D. “was very jovial about it,” and that everyone in the office laughed about the situation, and joked about “the sneeze implant.” That the patient would be “jovial” about an implant having been screwed into his sinus, resulting in a referral to an oral surgeon, and that there was office-wide joking about the incident is simply not credible, particularly in light of the complete absence of any contemporaneous records of such a seemingly critical element of the incident. Respondent believed that the implant must have been defective for her to have experienced the problem with removing the carrier, though her testimony in that regard was entirely speculative. There is no competent, substantial, or persuasive evidence to support a finding that the implant was defective. After determining that the implant was in Patient J.D.’s sinus, Respondent informed Patient J.D. of the issue, gave him a referral to an oral surgeon, prescribed antibiotics, and gave Patient J.D. her cell phone number. Each of those acts was appropriate. On July 29, 2014, an oral surgeon surgically removed the implant from Patient J.D.’s sinus. Patient J.D. sued Respondent for medical malpractice. The suit was settled, with the outcome including a $75,000.00 indemnity paid by Respondent’s insurer on her behalf. The Office of Insurance Regulation’s Medical Malpractice Closed Claims Report provides that the suit’s allegations were based on “improper dental care and treatment.” The evidence was not clear and convincing that Respondent failed to meet the minimum standards of performance prior to the procedure at issue by failing to obtain sufficient radiographic imaging showing Patient J.D.’s sinus anatomy, extent of available bone support, and/or root locations prior to the procedure. The evidence was clear and convincing that Respondent failed to meet the minimum standards of performance by failing to lift, or refer for lifting of, Patient J.D.’s sinus before placing the implant in the area of tooth 14, and by placing the implant into a curved root which could not accommodate the implant. The placement of Bond Bone was not adequate to address these issues. The evidence was clear and convincing that Respondent failed to meet the standard of care by failing to pay attention while trying to twist off the carrier and by failing to appropriately react to the sinking implant. The evidence was clear and convincing that Respondent paid, or had paid on her behalf, an indemnity of $75,000 for negligent conduct during treatment of Patient J.D. The perforation of Patient J.D.’s sinus was not, in itself, a violation of the standard of care. In that regard, Dr. Kinzler indicated that he had perforated a sinus while placing an implant. It was, however, the totality of the circumstances regarding the process of placing Patient J.D.’s implant that constituted a failure to meet the minimum standards of performance as described herein. Case No. 19-2902PL - The J.A.D. Amended Administrative Complaint Count I Case No. 19-2902PL, Count I, charges Respondent with violating section 466.028(1)(x) by: Failing to take adequate diagnostic imaging prior to placing an implant in the area of Patient J.A.D.’s tooth 8; Failing to pick an appropriately-sized implant and placing an implant that was too large; and/or Failing to diagnose and/or respond appropriately to the oral fistula that developed in the area of Patient J.A.D.’s tooth 8. Count II Case No. 19-2902PL, Count II, charges Respondent with violating section 466.028(1)(m) by: Failing to document examination results showing Patient J.A.D. had an infection; Failing to document the model or serial number of the implant she placed; and/or Failing to document the results of Respondent’s bone examination. Patient J.A.D. first presented to Respondent on March 3, 2016. His first appointment included a health history, full x-rays, and an examination. Patient J.A.D.’s complaint on March 3, 2016, involved a front tooth, tooth 8, which had broken off. He was embarrassed by its appearance, and desired immediate care and attention. Respondent performed an examination of Patient J.A.D., which included exposing a series of radiographs. Based on her examination, Respondent made the following relevant diagnoses in the clinical portion of her records: caries (decay) affecting tooth 7, gross caries affecting fractured tooth 8, and caries affecting tooth 9. Patient J.A.D. was missing quite a few of his back teeth. The consent form noted periodontal disease. The evidence is of Patient J.A.D.’s grossly deficient oral hygiene extending over a prolonged period. A consent form signed by Patient J.A.D. indicates that Patient J.A.D. had an “infection.” Respondent indicated that the term indicated both the extensive decay of Patient J.A.D.’s teeth, and a sac of pus that was discovered when tooth 8 was extracted. “Infection” is a broad term in the context of dentistry, and means any bacterial invasion of a tooth or system. The consent form was executed prior to the extraction. Therefore, the term “infection,” which may have accurately described the general condition of Patient J.A.D.’s mouth, could not have included the sac of pus, which was not discovered until the extraction. The sac of pus was not otherwise described with specificity in Respondent’s dental records. A pre-operative radiograph exposed by Respondent showed that tooth 8 had a long, tapering root. Respondent proposed extraction of tooth 8, to be replaced by an immediate implant. The two adjacent teeth were to be treated and crowned, and a temporary bridge placed across the three. Patient J.A.D. consented to this treatment plan. The treatment plan of extracting tooth 8 and preparing the adjacent teeth for crowns was appropriate. Respondent cleanly extracted tooth 8 without fracturing any surrounding bone, and without bone adhering to the tooth. When the tooth came out, it had a small unruptured sac of pus at its tip. Respondent irrigated and curretted the socket, and prescribed antibiotics. Her records indicated that she cleaned to 5 millimeters, although a radiograph made it appear to be a 7 millimeter pocket. She explained that inflammation caused the pocket to appear larger than its actual 5 millimeter size, which she characterized as a “pseudo pocket.” She recorded her activities. The response to the sac of pus was appropriate. Respondent reviewed the earlier radiographs, and performed a physical examination of the dimensions of the extracted tooth 8 to determine the size of the implant to be placed into the socket. Dr. Kinsler and Dr. Fish disagreed as to whether the radiographic images were sufficient to provide adequate information as to the implant to be used. Both relied on their professional background, both applied a reasonable minimum standard of performance, and both were credible. The evidence was not clear and convincing that Respondent failed to take adequate diagnostic imaging prior to placing an implant to replace Patient J.A.D.’s tooth 8. Respondent placed an implant into the socket left from tooth 8. The implant was in the buckle cortex, a “notoriously thin” bone feature at the anterior maxilla. The fact that it is thin does not make it pathological, and placement of an implant near a thin layer of bone is not a violation of the standard of performance as long as the implant is, in fact, in the bone. The implant used by Respondent was shorter than the length of tooth 8 and the tooth 8 socket, and did not have a full taper, being more truncated. The evidence of record, including the testimony of Dr. Kinzler, indicates that the length of the implant, though shorter than the tooth it was to replace, was not inappropriate. The evidence of record, including pre-extraction and post-implantation scaled radiographs offered as a demonstrative exhibit, was insufficient to support a finding that the implant diameter was too great for the available socket. Patient J.A.D. felt like the implant was too close to the front of his maxillary bone because it felt like a little bump on the front of his gums. That perception is insufficient to support a finding that the placement of the implant violated a standard of performance. Subsequent x-rays indicated that there was bone surrounding the implant. Clinical observations by Respondent after placement of the implant noted bone on all four walls of the implant. Her testimony is credited. The evidence that the tooth 8 implant was not placed in bone, i.e., that at the time the implant was placed, the implant penetrated the buccal plate and was not supported by bone on all four sides, was not clear and convincing. Respondent’s records document the dimensions and manufacturer of the implant. Implants are delivered with a sticker containing all of the relevant information, including model and serial number, that are routinely affixed to a patient’s dental records. It is important to document the model and serial number of implants. Every implant is different, and having that information can be vital in the case of a recall. Patient J.A.D.’s printed dental records received by the Department from Respondent have the implant size (5.1 x 13 mm) and manufacturer (Implant Direct) noted. The records introduced in evidence by the Department include a page with a sticker affixed, identified by a handwritten notation as being for a “5.1 x 13mm - Implant Direct.” (Pet. Ex. 11, pg. 43 of 83). The accompanying sticker includes information consistent with that required. Dr. Fish testified to seeing a sticker that appears to be the same sticker (“The implant label of 141, it just has the handwritten on there that it should be added.”), though it is described with a deposition exhibit number (page 141 of a CD) that is different from the hearing exhibit number. Dr. Fish indicated the sticker adequately documented the implant information. The evidence was not clear and convincing that the sticker was not in Patient J.A.D.’s records, or that Respondent failed to document the model or serial number of the implant she placed. Later in the day on March 3, 2016, Patient J.A.D. was fitted for a temporary crown, which was placed on the implant and the adjacent two teeth, and Patient J.A.D. was scheduled for a post-operative check. Patient J.A.D. appeared for his post-operative visit on March 10, 2016. He testified that he was having difficulty keeping the temporaries on, and was getting “cut up” because the two outer teeth were sharp and rubbed against his lip and tongue. Respondent noticed that Patient J.A.D. was already wearing a hole in the temporary. Since Patient J.A.D. was missing quite a few of his back teeth, much of his chewing was being done using his front teeth. His temporaries were adjusted and reseated. On March 17, 2016, Patient J.A.D. was seen by Respondent for a post-operative check of the tooth 8 extraction and implant placement. The notes indicated that Patient J.A.D. had broken his arm several days earlier, though the significance of that fact was not explained. He was charted as doing well, and using Fixodent to maintain the temporary in place. The records again noted that Patient J.A.D. had worn a hole in the back of the tooth 9 temporary crown. A follow up was scheduled for final impressions for the permanent crowns. On March 10 and March 17, 2016, Patient J.A.D. complained of a large blister or “zit” that formed over the area above the end of the implant. Patient J.A.D. had no recollection of whether Respondent told him he had an infection. He was prescribed antibiotics. The evidence was not clear and convincing that the “zit” was causally related to the placement of the implant. Patient J.A.D. also testified that the skin above tooth 9 was discolored, and he thought he could almost see metal through the skin above his front teeth. Patient J.A.D. next appeared at Respondent’s office on June 2, 2016, for final impressions. Respondent concluded that the site had not healed enough for the final impression. She made and cemented a new temporary, and set an appointment for the following month for the final impression. Patient J.A.D. did not return to Respondent. On September 28, 2016, Patient J.A.D. presented to the office of Dr. Harold R. Arthur for further treatment. The records for that date indicate that he appeared without his temporary restoration for teeth 7 through 9, stating that he had several at home, but they would not stay on. Dr. Arthur probed a “[s]mall (1.0 x 1.0 mm) red spot in facial keratinized gingiva communicating with implant.” After probing the opening in the gingiva and the “shadow” in the gingiva, he believed it was at the center of the implant body and healing screw. Dr. Arthur’s dental records for Patient J.A.D. over the course of the following year indicate that Dr. Arthur made, remade, and re-cemented temporary crowns for teeth 7, 8, and 9 on a number of occasions, noting at least once that Patient J.A.D. “broke temps” that had been prepared and seated by Dr. Arthur. On December 1, 2016, Patient J.A.D. was reevaluated by Dr. Arthur. He noted the facial soft tissue at the implant was red, with an apparent fistula. A periapical radiograph was “unremarkable.” The temporary crowns, which were loose, were removed, air abraded to remove the cement, and re-cemented in place. Patient J.A.D. was prescribed an antibiotic. He was again seen by Dr. Arthur on December 13, 2016. The temporary on tooth 9 was broken, which was then remade and re-cemented. The fistula was smaller but still present. Patient J.A.D. was seen by Dr. Arthur on February 2, 2017, with the tooth 9 temporary crown fractured again. The fistula was still present. Patient J.A.D. advised that “the bone feels like it’s caving in around where she put that implant.” That statement is accepted not for the truth of the matter asserted, but as evidence that the complaint was first voiced in February 2017. On April 4, 2017, more than a year after the placement of the implant, Patient J.A.D was seen by Dr. Arthur. Dr. Arthur determined that the implant for tooth 8 was “stable and restorable in current position.” The fistula was still present and, after anesthesia, a probe was placed in the fistula where it contacted the implant cover screw. Although Dr. Arthur replaced the implant abutment, he ultimately placed the final crown on the implant placed by Respondent, where it remained at the time of the final hearing. The fact that incidents of Patient J.A.D. breaking and loosening the temporary crowns that occurred with Respondent continued with Dr. Arthur supports a finding that the problems were, more likely than not, the result of stress and overuse of Patient J.A.D.’s front teeth. On October 24, 2016, a series of CBCT radiographs was taken of the implant and its proximity to tooth 7. Dr. Kinzler testified that, in his opinion, the implant was of an appropriate length, but was too large for the socket. Much of his testimony was based on the October 24 radiograph and his examination of the resulting October 29, 2016, report. Although the report indicated that there was minimal bone between the implant and the root of tooth 7, and that the buccal cortex appeared thinned or eroded, those observations are of limited persuasive value as to whether the standard of performance was met almost eight months prior. Patient J.A.D. obviously worked, and overworked, his dental appliances. Without more, the evidence is not clear and convincing that his subsequent and repeated problems, including “thinned or eroded” bone in the buccal cortex, were the result of a violation of the standard of performance in the sizing and placement of the tooth 8 implant by Respondent.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health, Board of Dentistry, enter a Final Order: Dismissing the Administrative Complaint in Case No. 19-2898PL and the Amended Administrative Complaint in Case No. 19-2902PL; With regard to Case No. 19-2899PL: 1) dismissing Count I of the Administrative Complaint; 2) determining that Respondent failed to comply with the applicable standard of performance in the care and treatment of Patient S.S. by: failing to adequately diagnose the condition of the roots of tooth 30; failing to adequately obturate the canals of tooth 30 during root canal treatment; failing to adequately obturate the canals of tooth 31 during root canal treatment; failing to take a new crown impression of tooth 31 following changes to the tooth’s margins; and failing to adequately assess and correct the crown on tooth 31 when the fit was compromised, as alleged in Count II of the Administrative Complaint; and 3) determining that Respondent did not fail to comply with the applicable standard of performance in the care and treatment of Patient S.S. by failing to adequately diagnose decay in tooth 30, as alleged in Count II of the Administrative Complaint; With regard to Case No. 19-2900PL, determining that Respondent failed to comply with the applicable standard of performance in the care and treatment of Patient G.H. by seating a crown containing an open margin on tooth 13 and failing to adequately diagnose issues with the crown on tooth 13, and by failing to perform appropriate corrective treatment after having sufficient evidence of the deficiencies, as alleged in the Administrative Complaint; With regard to Case No. 19-2901PL: 1) determining that Respondent failed to comply with the applicable standard of performance in the care and treatment of Patient J.D. by: failing to lift, or refer for lifting of, Patient J.D.’s sinus before placing an implant in the area of tooth 14; failing to appropriately place the implant by attempting to place it into a curved root which could not accommodate the implant; failing to react appropriately to the sinking implant by trying to twist off the carrier instead of following the technique outlined in the implant’s manual; and paying, or having paid on her behalf, an indemnity in the amount of $75,000 as a result of negligent conduct in her treatment of Patient J.D., as alleged in the Amended Administrative Complaint; and 2) determining that Respondent did not fail to comply with the applicable standard of performance in the care and treatment of Patient J.D. by failing to obtain sufficient radiographic imaging showing Patient J.D.’s sinus anatomy, extent of available bone support, and/or root locations; Suspending Respondent’s license in accordance with rule 64B5-13.005(1)(x) and rule 64B5-13.005(3)(e), to be followed by a period of probation, with appropriate terms of probation to include remedial education in addition to such other terms that the Board believes necessary to ensure Respondent’s practical ability to perform dentistry as authorized by rule 64B5- 13.005(3)(d)2.; Imposing an administrative fine of $10,000; and Requiring reimbursement of costs. DONE AND ENTERED this 31st day of January, 2020, in Tallahassee, Leon County, Florida. S E. GARY EARLY 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 31st day of January, 2020. COPIES FURNISHED: George Kellen Brew, Esquire Law Office of George K. Brew Suite 1804 6817 Southpoint Parkway Jacksonville, Florida 32216 (eServed) Kelly Fox, Esquire Department of Health 2585 Merchant’s Row Tallahassee, Florida 32311 (eServed) Octavio Simoes-Ponce, Esquire Prosecution Services Unit Department of Health Bin C-65 4052 Bald Cypress Way Tallahassee, Florida 32399 (eServed) Chad Wayne Dunn, Esquire Prosecution Services Unit Department of Health Bin C-65 4052 Bald Cypress Way Tallahassee, Florida 32399 (eServed) Jennifer Wenhold, Interim Executive Director Board of Dentistry Department of Health Bin C-08 4052 Bald Cypress Way Tallahassee, Florida 32399-3258 (eServed) Louise Wilhite-St. Laurent, General Counsel Department of Health Bin C-65 4052 Bald Cypress Way Tallahassee, Florida 32399 (eServed)
The Issue The issues in this case, as set forth in the Amended Administrative Complaints in each respective case, are as follows: DOH Case No. 2010-01128/DOAH Case No. 11-5692 Count One. Whether Respondent, Jacinta Irene Gillis, M.D. (hereinafter referred to herein as "Dr. Gillis"), violated sections 458.331(1)(nn) and 458.326, Florida Statutes (2008 and 2009), by: Failing to diagnose patient M.G. with intractable pain prior to prescribing a controlled substance under Schedules II-V, as provided in section 893.03, from on or about December 19, 2008 through December 30, 2009; By inappropriately or excessively prescribing potentially lethal, highly abused, controlled substances, to wit: oxycodone, oxycontin, Percocet, and Valium, to M.G. without justification during the same time period; By inappropriately or excessively prescribing controlled substances to M.G. prior to exploring other treatment modalities or rehabilitation; and By failing to order a urine drug screen on M.G. at any time during her course of treatment. Count Two. Whether Dr. Gillis failed to keep legible medical records justifying the course of treatment for M.G. in one or more of the following ways: By failing to document justification for inappropriately or excessively prescribing controlled substances during her course of treatment; and By failing to document justification for not ordering a urine drug screen during the course of treatment. Count Three. Whether Dr. Gillis failed to meet the required standard of care in regards to her treatment of M.G. in one or more of the following ways: By inappropriately or excessively prescribing controlled substances without justification; By failing to confirm whether M.G. presented to a psychiatrist or psychologist after the initial referral by Dr. Gillis; By failing to order a urine drug screening of M.G. during her course of treatment; and By inappropriately or excessively prescribing controlled substances prior to exploring other modalities or rehabilitation. Count Four. Whether Dr. Gillis prescribed controlled substances, other than in the course of her professional practice, by prescribing controlled substances inappropriately or excessively in one or more of the following ways: By inappropriately or excessively prescribing controlled substances prior to exploring other treatment modalities or rehabilitation for M.G.; By inappropriately or excessively prescribing controlled substances without ordering a urine drug screening for M.G.; and By inappropriately or excessively prescribing controlled substances to M.G. without justification. DOH Case No. 2008-20661/DOAH Case No. 11-5961 Count One. Whether Dr. Gillis violated section 458.331(1)(nn), Florida Statutes (2008),1/ and Florida Administrative Code Rule 64B8-9.013(3) in one or more of the following ways: By failing to perform or document performing a complete physical exam of R.S.; By failing to explore or document exploring other treatment modalities or rehabilitation for R.S.; By failing to obtain or document obtaining a complete medical history of R.S.; By failing to document the nature or intensity of R.S.'s pain; By failing to document the current or past treatments of R.S.'s pain; By failing to document information on the effect of pain on R.S.'s physical or psychological function; By failing to develop or document developing a treatment plan for R.S.; and By failing to determine or document determining if there were any underlying or coexisting diseases or conditions for R.S. Count Two. Whether Dr. Gillis violated sections 458.331(1)(nn) and 458.326 in one or more of the following ways: By failing to diagnose R.S. with intractable pain prior to prescribing controlled substances, i.e., Percocet; By prescribing 90 tablets of Percocet 10/325 to R.S. without justification; By prescribing Percocet to R.S. without exploring other treatment modalities or rehabilitation; and By inappropriately prescribing Percocet to R.S. after R.S. reported that he was not currently being treated for pain. Count Three. Whether Dr. Gillis failed to keep legible medical records justifying the course of treatment for R.S. in one or more of the following ways: By failing to document justification for prescribing Percocet to R.S.; By failing to document a complete physical examination of R.S. prior to prescribing Percocet; By failing to document a complete medical history of R.S. prior to prescribing a controlled substance; By failing to document a urine screen on R.S.; and By failing to document a diagnosis of intractable pain for R.S. Count Four. Whether Dr. Gillis violated sections 458.331(1)(nn) and 458.326 in one or more of the following ways: By failing to perform or document performing a complete physical examination of D.H. on either of two visits; By failing to obtain or document obtaining a complete medical history on D.H.; By failing to explore or document exploring other treatment modalities or rehabilitation for D.H.; By failing to document the nature or intensity of D.H.'s pain; By failing to document the current or past treatments of D.H.'s pain; By failing to document information on the effect of pain on D.H.'s physical or psychological function; By failing to develop or document a treatment plan for D.H.; and By failing to determine or document determining if there were any underlying or coexisting diseases or conditions for D.H. Count Five. Whether Dr. Gillis violated sections 458.331(1)(nn) and 458.326 in one or more of the following ways: By failing to diagnose D.H. with intractable pain prior to prescribing a controlled substance, i.e., oxycodone; By prescribing 120 tablets of 30 mg oxycodone without justification; By prescribing 120 tablets of 30 mg oxycodone prior to exploring other treatment modalities or rehabilitation for D.H.; and By prescribing oxycodone to D.H. after D.H. reported that he was not experiencing any pain. Count Six. Whether Dr. Gillis failed to keep legible medical records justifying the course of treatment for D.H. in one or more of the following ways: By failing to document justification for prescribing 120 tablets of 30 mg oxycodone; By failing to document a complete physical examination of D.H. prior to prescribing a controlled substance; By failing to document a complete medical history of D.H.; By failing to document urine drug screening of D.H. prior to prescribing a controlled substance; and By failing to document a diagnosis of intractable pain for D.H. prior to prescribing a controlled substance.
Findings Of Fact The Department is the state agency having responsibility for monitoring health care professionals, including medical doctors. Dr. Gillis is a medical doctor licensed in Florida, North Carolina, and Iowa. She is not board-certified in any area of medicine, but claims to be "eligible" for board-certification in the field of internal medicine. Dr. Gillis received her medical degree from Meharry Medical College in Nashville, Tennessee, in 1997. She completed her internal medicine residency in 2003. Her medical career includes the following places of employment: Medical director/staff physician at Tennessee prison for women: March-August 2003; Hospitalist at Hilton Head Regional Medical Center: August 2003-February 2004; Pain management "specialist" in Atlanta, Georgia: March-September 2004; Staff physician for Illinois Correctional Facilities: September 2004-January 2005; Pain specialist/physician in Rock Island, Illinois: March-September 2005; Hospitalist at Brommen Medical Center in Bloomington, Illinois: May-August 2005; Hospitalist at Horizon Medical Center in Dixon, Tennessee: September 2005-January 2006; Pain specialist for National Health Services Clinic in Nashville, Tennessee: June-August 2006; Hospitalist at Kedlic Medical Center in Richland, Washington: September 2006-January 2007; Hospitalist at Auburn Regional Medical Center in Auburn, Washington: January-June 2007; Hospitalist at Mercy Medical Center in Sioux City, Iowa: July-August 2007; Hospitalist at Albermarle Medical Center in Elizabeth City, North Carolina: September-December 2007; Hospitalist at National Medical Affiliates in Punta Gorda, Florida: January-July 2008; Pain management specialist at UR Medical Clinic in St. Petersburg, Florida: July-November, 2008; and Pain management specialist at Dollar Medical Clinic in St. Petersburg, Florida: January 2009-October 2010. The Department is pursuing sanctions against Dr. Gillis based on her provision of medical care to three patients: D.H., and M.G. Both D.H. and R.S. are pseudonyms used by Deputies Negersmith and Johnson, respectively, as part of an undercover investigation of the clinic where Dr. Gillis was working in 2008. Their initials are used throughout this order for continuity, because all of the patient records and other evidence used those initials, rather than patient names. M.G. was a bona fide patient of Dr. Gillis's while she was operating another clinic in 2009-2010. In 2008, Dr. Gillis worked at a clinic operated by UR Medical Group, Inc., located in Pinellas Park, Florida. The clinic (referred to herein as the "UR Clinic") was owned by Renee Demasso, a non-physician. Dr. Gillis was the only medical doctor on staff at the clinic when she worked there. Another employee at the clinic was Quinton Knight, a large African- American male, who served as the office receptionist. The clinic had a "recruiter" named Jason Norris.2/ A recruiter is a person hired by the clinic to find new patients for the clinic's medical staff, i.e., for Dr. Gillis. On August 4, 2008, Negersmith, posing as D.H., was escorted to the UR Clinic by Norris. Upon arrival, he was given a patient information sheet to fill out. Norris directed him to write "severe lower back pain" on the sheet as the purpose of the visit. D.H. filled out the sheet, providing the following information: His pseudonym, address and contact information; His gender, marital status, height and weight; A fake social security number and date of birth; A fake driver's license number; His supposed occupation, i.e., a lineman for a private employer; A purported ailment, i.e., "severe lower back pain, weakness in knees" as the purpose for his visit; No insurance information; Neck/back pain and headaches as his medical history; A signature and date. All of the information provided was, of course, false. That is, D.H. was a fictitious name for a person pretending to be a patient. After filling out the form, D.H. discussed with Norris the cost of seeing the doctor. Norris said it would be a $350 charge. After approximately 45 minutes, D.H. was escorted to another waiting area, a vestibule separate from the main waiting area. After a short wait of five to ten minutes, D.H. was shown into an examination room where he met Dr. Gillis. D.H. was told to weigh himself on a floor scale and told Dr. Gillis his weight, 264 pounds. She then took his blood pressure which was 140/80. Dr. Gillis told D.H. that he might want to take some medication to lower his blood pressure. Dr. Gillis inquired as to the history of his present illness. According to the History and Physical Form (referred to herein as the patient chart) filled out by Dr. Gillis as she talked with the patient, D.H. said he had no pain (zero on a one-to-ten scale). Dr. Gillis wrote that D.H. "has difficulty explaining what he is really feeling" and that D.H. said muscle relaxers do not work for him. D.H. then told Dr. Gillis that oxycodone helps him to relax. Dr. Gillis then had D.H. perform three simple tasks: walking a short distance on his toes, walking on his heels, and raising his arms above his head. D.H. walked as directed, but he could not raise his arms higher than shoulder height because he was concealing a firearm in his waistband and raising his arms any higher would have revealed the weapon.3/ So he raised his arms up to shoulder height and then lowered them. D.H. cannot remember whether Dr. Gillis asked him why he could not raise his arms higher. Her notations on the patient chart indicate only that D.H. has less strength in his right foot (leg) and less range of motion in his left arm. At the conclusion of the examination, Dr. Gillis listed "chronic back and neck problems, chronic pain symptoms, non-specific" as the assessment and treatment plan for D.H. The lower left corner of the patient chart has an indication saying "needs records." D.H. purposefully avoided using the word "pain" throughout his examination. The only mention of pain was on the intake sheet he filled out, where he checked a box entitled neck/back pain. D.H. told Dr. Gillis that oxycodone helped him relax. She did not inquire as to whether he was taking any other medications or suggest any other modalities or treatment with D.H. After the examination, D.H. went back to the front office where he received a prescription for 120 tablets of 30 mg oxycodone and for 90 tablets of 600 mg Motrin. He handed Norris $350 in cash, which Norris then gave to Knight. No receipt was provided for the payment. D.H. then went to a local pharmacy and had the prescription filled. Pursuant to prior arrangements, he gave 60 of the oxycodone tablets to Norris for sale on the street.4/ The remaining tablets were placed into locked storage. Norris did not know D.H. was a police officer, of course. On August 27, 2008 (23 days later), D.H. appeared at the UR Clinic again. This time he was accompanied by Deputy Johnson who was posing as patient R.S. The deputies arrived at the clinic and looked for Norris, who was usually hanging around the parking lot. However, Norris was not there, and the deputies could not reach him via telephone, so they decided to go into the clinic anyway and see if they could obtain additional drugs. When D.H. and R.S. came into the clinic without Norris accompanying them, Knight became very upset and agitated. D.H. told Knight that Norris had recently changed his cell phone number, and it was not possible to contact him right then. R.S. started to walk out of the office, but Knight called him back and asked him for $350 and a copy of his identification. Knight then gave R.S. a patient information sheet to fill out. D.H. was not asked to fill out any paperwork at that time. D.H. was then escorted to the examination room where he saw Dr. Gillis again. No tests or physical examination were conducted. The only thing Dr. Gillis asked D.H. was whether he had brought his medical records with him. D.H. told her he had not had time to get them from his prior doctor yet. Dr. Gillis instructed D.H. not to come back to the clinic without his medical records. At the foot of the chart, Dr. Gillis wrote "Dr. Rew, family doctor; 2 weeks records; brought in personally." The note was not explained by Dr. Gillis. The patient chart filled out by Dr. Gillis on the second visit was extremely abbreviated in content. Under chief complaint, Dr. Gillis wrote, "patient states treatment plan is working; no complaints." The chart contains his vital signs: pulse of 142/80 and weight of 268 pounds. The history of present illness section of the form says only that D.H has a zero out of ten level of pain with treatment. She noted that has "no changes from prior testing" and added a note to "refill meds." The assessment and treatment plan section says "chronic back and neck problem." According to D.H., he never mentioned any problem to Dr. Gillis. Dr. Gillis did not inquire as to whether D.H. was currently taking any medications, but wrote, "oxycodone #120" and "Motrin 600 #90" on the current medications section of the chart. There was no physical examination of any kind performed on this visit. D.H. then went out to the office and got his prescription for 120 tablets of 30 mg oxycodone. Dr. Gillis never asked him whether he had taken all of the prior prescription, nor did she discuss pain with him. As part of his cover, D.H. intentionally avoided the use of the word "pain" when talking to Dr. Gillis. Meanwhile, R.S. completed his patient information sheet, providing the following information: His pseudonym, address and contact information; His gender, marital status, height and weight; A fake social security number and date of birth; A fake driver's license number; His occupation (carpenter work) and employer (unemployed); Purpose of visit, which D.H. listed as "stiffness in both shoulders"; No auto accident involved and no insurance available; Medical history options of high blood pressure and neck/back pain were checked in the list of various diseases and conditions listed on the sheet; An allergy to Keflex; Referred to clinic by a friend. R.S. was then taken back to an examination room where he met Dr. Gillis. He, too, contrived not to mention the word pain in his conversations with Dr. Gillis. He simply said he had a stiff shoulder. Dr. Gillis took his vital signs and had R.S. do the same physical tests that D.H. had performed in his first visit. remembers Dr. Gillis listening to his chest with a stethoscope and then examining his shoulder. The patient chart filled out by Dr. Gillis during R.S.'s visit contained the following information: "Chief complaint--Self employed; carpentry; history of surgery on back, shoulder problems one year ago; surgery and thus pain; no history of pain management." She correctly noted that R.S. was not currently on any medications. Dr. Gillis's assessment and treatment plan for R.S. was listed on the chart as chronic shoulder pain. There is no explanation for that notation. At the bottom corner of the chart, Dr. Gillis wrote "MRI of neck/shoulder; Dr. Wood, Pinellas County Orthopedic." That notation was not explained further by Dr. Gillis. R.S. went back to the front office where he was handed a prescription for Percocet 10/325, even though he never asked for medication. The Percocet was at the maximum strength (10 mg) for oxycodone content for that medication. R.S. then left the office, identified photographs of Dr. Gillis and Knight for his superiors and had no further involvement with the investigation. The testimony of Negersmith and Johnson as to their undercover actions was credible. Each of them had a clear and unambiguous memory of the events and did not appear to have any prejudices or ill intent that might negatively affect their testimony. The truth and veracity of their statements is accepted. At some point in time after the August 27, 2008, visit, the PCSO decided they had enough evidence to prosecute the UR Clinic as a "pill mill." As part of that prosecution, Dr. Gillis was pulled over in a traffic stop one day as she was leaving the clinic. After detaining her and explaining the charges that were being filed, the deputies advised Dr. Gillis to retain all patient records for patients she had been treating at the clinic. Later, Dr. Gillis cooperated with the sheriff's office and provided sets of original patient records to them. Dr. Gillis thereafter left her employment with the UR clinic and opened her own clinic. Patient M.G. presented to Dr. Gillis at her new place of employment, Dollar Medical Clinic, on December 19, 2008. Dr. Gillis was the owner and operator of this new clinic. M.G. filled out a patient information sheet which garnered the following information about him: Name, address and contact information; Marital status (married), and emergency contact information; Height, weight, and date of birth; Purpose of visit, listed as "refill on meds, follow-up on surgery." Auto accident on November 17, 2007; Insurance company information; and Medical history of neck/back pain, headaches, and arthritis. M.G. was then examined by Dr. Gillis. She filled out a patient chart for him that listed a history of surgery and treatments for pain. The patient chart lists Dr. Spuza and Dr. Nucci as physicians from whom M.G. had received care in the past. The patient chart noted that M.G. needed to be referred to a psychiatrist or psychologist as soon as possible. There was also a note indicating that M.G.'s MRI needed to be confirmed. Then there was a note written by Dr. Gillis saying "[p]atient is not going to be patient." There was no explanation as to what that note meant. The assessment and plan of treatment was then listed as "pain dependent" (although the writing on the patient chart is not very clear, and no testimony was elicited from Dr. Gillis to confirm what was written) and that the patient was advised about decreasing his pain medications. M.G. complained of pain at an eight on the one to ten scale with "treatment with oxycodone times four," presumably meaning four times per day. Upon completion of her examination of M.G., Dr. Gillis wrote him a prescription for 240 tablets of 30 mg oxycodone, 120 tablets of 40 mg oxycontin, 30 tablets of 10 mg valium, and 60 tablets of 500 mg naprosyn. According to the prescription, M.G. was supposed to take one of the oxycodone tablets every three hours, 24 hours per day, i.e., eight times per day. That was in addition to the oxycontin, which was to be taken every six hours. According to Dr. Gerber, "no pain doctor in the country would write a prescription like that." It would also be almost impossible for a patient to take all of those medications as prescribed. Approximately one month later, on January 16, 2009, M.G. returned to Dr. Gillis for the first of several follow-up visits. The patient chart filled out by Dr. Gillis that day indicates the chief complaint by M.G. to be "pain, top of buttocks radiating down leg to foot on left side." M.G. said his pain level was an eight out of ten with his medications. Dr. Gillis wrote a note to refill the medications and that there were "no acute changes" to M.G.'s condition. This time, the assessment and treatment plan was abbreviated as "A/P." This was the beginning of very cursory notes in the patient charts for M.G. The notes on the chart became shorter and less detailed as time went on. The "A/P" was listed as chronic neck pain and dental issues. Dr. Gillis then wrote prescriptions for 240 more oxycodone tablets, 120 more oxycontin tablets, 30 valium and 30 amoxicillin tablets. There is no record in the chart as to why the amoxicillin was added to M.G.'s medication regimen. There is no justification for providing essentially the same regimen of treatment when the patient was complaining of pain at a level of eight out of ten. M.G. came back for another follow-up on February 13, 2009. At that visit, Dr. Gillis charted the chief complaint as "thorac lumbar surgery [indecipherable] months ago." Again M.G. complained of a level of pain at eight out of ten when using his medications. Dr. Gillis noted her intent to refill the medications and that there were no acute changes in M.G.'s condition. His "A/P" was listed as chronic back pain. A prescription for the same medications, same doses, and same amounts as the previous visit was issued. M.G. returned on March 12, 2009, for a follow-up visit. The chief complaint at that time was "patient has difficulty [indecipherable]." Under history of present illness, Dr. Gillis wrote that M.G. has no history of pain prior to surgery and that he gets no relief from valium or Soma. There is no prescription for Soma in the records, so M.G. must have been getting that drug from some other source. There is no indication Dr. Gillis inquired as to where he got the medication, whether he was on any other medications, or how often he was taking the medication. Dr. Gillis again wrote that there were no acute changes in M.G.'s condition although he did not present with the same chief complaint. The "A/P" appears to be chronic back pain, although the writing is not clear. Prescriptions for oxycodone and oxycontin were renewed as before, and a prescription for Ambien was added. The valium prescription was not refilled. No explanation for the change in the drug regimen was provided by Dr. Gillis. On April 4, 2009, M.G. returned for another visit. This time his chief complaint was that he ran out of medications and had a seizure. There is no indication that Dr. Gillis inquired as to the type of seizure or whether M.G. had received any treatment for it. There is no evidence as to when M.G. ran out of his medications or how many pills he had taken since the prior visit. M.G. still complained of pain at a level of eight out of ten with his treatment. There is no indication of his pain level after he ran out of his medications. The "A/P" was listed as chronic back pain. The prescriptions written by Dr. Gillis for this visit were the same as the previous visit. For his next visit, May 12, 2009, there is no chief complaint listed on the patient chart. Dr. Gillis again wrote that there was no acute change in the patient's condition, that M.G.'s pain level was 6.5 out of ten with his treatment, and that the prescriptions should be refilled. The same oxycodone and oxycontin prescriptions (240 and 120 tablets, respectively) were written, along with the Ambien prescription. M.G. visited Dr. Gillis again on June 12, 2009. The chief complaint for that visit was low back pain caused by tripping over a toy car at his home. M.G.'s pulse and weight were measured, and there was a note on the chart that M.G. had "CBP" (which is presumably chronic back pain) and a toothache. A notation at the bottom of the chart said "25$," but is not explained. Dr. Gillis prescribed the same regimen of 240 pills of oxycodone and 120 pills of oxycontin. In the current medications section of the chart, Dr. Gillis wrote "Meds." That notation was not explained. As in each of the previous visits, Dr. Gillis did not perform a urine screen to determine whether M.G. had been taking the medications or not. M.G. came back to see Dr. Gillis on July 6, 2009. The chart for that visit says the chief complaint by M.G. was a surgical procedure called percantaneous distectomy and that M.G. "had care since the procedure." There is also a note that indicates "5 procedures," but the note is not explained. M.G. reported his pain level as five out of ten, with medications, and ten out of ten, without. Dr. Gillis prescribed the same, oxycodone and oxycontin medications as in the previous visits. There is no explanation as to why the medication levels were the same, even though M.G. was reporting less pain than in prior visits and had undergone surgery during the interim. M.G.'s next visit to Dr. Gillis was on August 5, 2009. His chief complaint on that day is essentially unreadable, and Dr. Gerber could not decipher it at all. There is a mention of Xanax in the chart, but its purpose is not explained. M.G.'s pain level is listed as six out of ten, with medications, ten out of ten, without. That is close to the pain levels described in the prior visit. However, without some sort of physical or functional exam or a psychological assessment, it was impossible to determine whether M.G. was functioning, no matter what his pain level. Dr. Gillis refilled the oxycodone and oxycontin prescriptions and added a prescription for ten tablets of Percocet 1/650, a minimal and almost useless dose. The "A/P" listed chronic lower back pain and seizure activities, but there was no discussion as to what seizures occurred or when. On September 9, 2009, M.G. presented with a complaint of a stiff neck. The chart mentioned an MRI, but did not explain or elaborate on it. The assessment of the patient was listed as "Ch LBP" (presumably chronic lower back pain), but there was no explanation of the relationship between the assessment and the presenting problem. There was no documentation of care in treatment on the patient chart. Dr. Gillis refilled the oxycodone and oxycontin and also added a prescription for Mobic, an anti-inflammatory medication. M.G. came back to visit Dr. Gillis on October 7, 2009. The chief complaint said M.G. had good and bad days and that the last surgery did not have good results. His pain level was down to six out of ten, with medications, and ten out of ten, without. Chronic lower back pain continues to be the assessment and treatment plan notation. Nonetheless, he was prescribed the exact same levels of oxycodone and oxycontin as all of the other visits. On November 4, 2009, M.G. returned to see Dr. Gillis. A different patient chart form was utilized by Dr. Gillis at that visit. The form includes a question, "Hello, how are you doing?" to which M.G. responded, "Terrible." M.G. said the ongoing treatment was working, but that he was not sleeping better. His pain level on that day was back up to seven out of ten, with medications. In her notes, Dr. Gillis said to "refill with adjustment with valium." There is no explanation as to why valium would be added to M.G.'s medication regimen. M.G. then visited Dr. Gillis on December 2, 2009. In response to the question about how he was feeling, M.G. said he was "planning for surgery; not doing good." He said the treatment was working and he was sleeping better. The assessment update on the chart said chronic lower back pain with exacerbations. The exacerbations were not explained. M.G. was prescribed the same medications as the previous visit. M.G.'s thirteenth and last monthly visit to Dr. Gillis occurred on December 20, 2009. When asked how he felt, M.G. answered "Alright." He said the treatment was working, but that some of his medications had been stolen. He reported not having oxycodone for nine days and oxycontin for seven days (or, possibly, not having nine oxycodone tablets or seven oxycontin tablets, the record is not clear.) He also said he had taken his medications that very day, but there was no indication in the record as to which medications he was talking about. He said his lower back pain was at a level of seven to eight on that day. Dr. Gillis did not inquire about the inconsistent statements and refilled his prescriptions anyway. The patient records for M.G. do not discuss whether he was paying for the cost of the prescriptions out-of-pocket or whether insurance was covering some of the cost. The cost of the medications would have been approximately $600.00 per month. It is clear that M.G. presented as a complex patient and was obviously receiving medical care elsewhere at the same time he was being treated by Dr. Gillis. He was apparently receiving medications from other sources at the same time Dr. Gillis was treating him. Dr. Gillis was at least somewhat aware of M.G.'s other medical care, but she never did monitoring or screening of M.G. that would have given her insight into how her treatment plan was interacting with M.G.'s other treatment. And, once Dr. Gillis saw that her treatment was not alleviating M.G.'s pain, she should have referred him to a board-certified pain management specialist. Dr. Marc Gerber was accepted at final hearing as an expert witness for the Department. Dr. Gerber is a board- certified pain management specialist who currently treats patients with pain management issues. Dr. Gerber's testimony was clear, concise, and credible. He did not appear to have any prejudice against Dr. Gillis as a person, but was very concerned about how she was practicing medicine. His testimony forms the basis for the following findings of fact. Relying upon the patient charts and patient information sheets provided by Dr. Gillis, there does not appear to have been a diagnosis of intractable pain for M.G. Intractable pain is pain for which, in the generally accepted course of medical practice, the cause cannot be removed and otherwise treated. There does not appear to have been an appropriate and complete physical examination of M.G. performed by Dr. Gillis. The oxycodone and oxycontin prescriptions for M.G. over a 13-month period are excessive. Despite her initial note wherein she advised M.G. that his medication levels must be decreased, Dr. Gillis continued the same regimen of oxycodone and oxycontin throughout M.G.'s treatment. There is no indication the medications were working, as M.G. continued to complain about pain for the entire 13 months he was under Dr. Gillis' care. Other than adding other medications, Valium, Mobic, Percocet, and Ambien for very brief periods, there was no change to M.G.'s prescription regimen. The patient charts for the visits to Dr. Gillis do not contain any justification for why the medications were prescribed in those quantities. The amount of oxycodone and oxycontin prescribed was, in itself, excessive. According to the prescriptions, M.G. was supposed to take one oxycontin every six hours. Oxycontin is a time-release medication that should only be taken once every 12 hours at most. M.G. was prescribed eight tablets of 30 mg oxycodone per day, i.e., one every four hours or two every eight hours--in addition to the oxycontin. The totality of those medications could be lethal. There are no indications in the patient charts that Dr. Gillis was taking vital signs and doing a physical evaluation of M.G. at every visit. Nonetheless, she continued to prescribe the high dosages of potentially lethal medications. Most importantly, Dr. Gillis never had a urine drug screen done on M.G. Such a test would have revealed whether M.G. was actually taking the drugs he was prescribed. It would have provided a determination of the level of drugs or other substances in M.G.'s body and then how the drugs were affecting him. A urine drug screen done at the time of M.G.'s earliest visit would have established a baseline for measuring the effectiveness and utility of future prescriptions. For a patient such as M.G., with a history of surgeries, a need for psychiatric evaluation, and a propensity to take large amounts of drugs, a urine drug screen would have been an essential element of the periodic review required for all such patients. Dr. Gillis erroneously stated that she had rejected and R.S. as patients after their first and second visits, respectively. The evidence shows that both "patients" voluntarily stopped visiting the clinic after completing their undercover work. Neither of the patients was told by Dr. Gillis not to return (although D.H. was told not to come back without bringing his medical records). Dr. Gillis did not testify at final hearing and did not provide any credible rebuttal to the facts asserted by the Department's witnesses. Dr. Gillis did demonstrate an understanding of the practice of medicine through her questioning of the Department's medical expert, but her treatment of patients R.S., D.H. and M.G. was deficient. The Department did not specifically allege, nor was there any evidence to support that Dr. Gillis intentionally practiced medicine in an inappropriate manner. However, her treatment of the patients in question indicates serious shortcomings in her ability to effectively and appropriately manage pain for her patients. Furthermore, Dr. Gillis represented herself at final hearing and, without assistance of counsel, was not able to effectively present a strong defense to the Department's allegations. Although she was given ample opportunity to testify concerning her care and treatment of the patients at issue, she declined to do so. Although the Department's perception of Dr. Gillis' treatment of D.H., R.S. and M.G. was based on its expert's review of medical records only, Dr. Gillis's refusal to testify left Dr. Gerber's perception as the only reliable source of information.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered by the Department of Health suspending the license of Respondent, Jacinta Irene Gillis, M.D., until such time as Dr. Gillis can demonstrate competency in the practice of medicine, especially as it relates to pain management, to the satisfaction of the Board of Medicine. It is further RECOMMENDED that the final order assess the cost of investigating and prosecuting this case and that payment of such costs be a condition precedent to ending the suspension of Dr. Gillis's license to practice. DONE AND ENTERED this 3rd day of February, 2012, in Tallahassee, Leon County, Florida. S R. BRUCE MCKIBBEN 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 3rd day of February, 2012.
Findings Of Fact The Respondent, Charles P. Shook, M.D., is a medical doctor having been issued license number 0020414, pursuant to Chapter 458, Florida Statutes. He is board certified in the areas of general and peripheral vascular surgery and practices in those specialty areas in Fort Myers, Lee County, Florida. He has been practicing in Lee County since 1973. The Petitioner is an agency of the State of Florida, charged with enforcing the licensure and practice standards embodied in Chapter 458, Florida Statutes and related statutes and rules and imposing disciplinary measures for departure from those standards by physicians licensed in Florida when such are proven. Mrs. Betty A. Fiore, at times pertinent hereto, was an obese, 47-year old female, with a history of thrombo-phlebitis and progressively enlarging and painful bilaterial varicosities of the veins in her right and left legs. She was admitted to Fort Myers Community Hospital on January 28, 1979, by the Respondent, for performance of a bilateral "vein-stripping" surgical procedure. Her medical history reflected that she had had a similar vein-stripping procedure performed over 20 years previously. The patient was operated on by the Respondent on January 29, 1979, beginning at approximately 9:25 a.m. The procedure was quite lengthy due to certain complications and lasted until 1:25 p.m. that day. After normal preparations, under general anesthesia, the Respondent began the operation by performing an oblique groin incision on the left leg just below the inquinal liagment, approximately ten centimeters in length. The incision penetrated the subcutaneous tissue and, as the "fossa-ovalis" was approached, the Respondent noted a significant amount of scar tissue, apparently related to the earlier surgical procedure, which obliterated and concealed much of the normal anatomy and structure in the area of surgery. It was of such a dense nature that only a faintly palpable pulse could be felt in the vessel. The Respondent dissected out the various venous branches in the area and individually ligated them. During his dissection process, the distal common femoral artery was injured by being slightly nicked with the surgical instrument. Repair procedures for the injury to the artery were carried out as will be described below. In any event, the "codman stripper" was employed in carrying out the stripping operation on the vein in question and additionally, several incisions were made around the calf of the leg to alleviate smaller varicosities. One large perforating vein in the malleolar area had to be ligated after the superficial portion had been stripped away. The Respondent then began to perform a similar procedure on the right leg, in spite of the initial difficulties he had had on the left leg, because he did not expect such severe scar tissue involvement with the anatomical structures in the area of incision on both legs. When he carried out the incision on the right leg however, he found that the anatomy of the right leg was essentially the same as that of the left and that substantial scar tissue reaction had occurred, related to prior surgery, with obliteration of much of the normal anatomy, including concealment of the femoral artery. Due in large part to these anatomical changes and complications involved in dissecting out the various venous branches involved in the stripping procedure, the right femoral artery was also slightly nicked by the scalpel. The Respondent attempted to suture the femoral arteries nicked in both legs at the time these injuries occurred, but the sutures would not hold in the arteries due to some then unknown, medical condition. After the same failure to hold sutures was encountered with regard to both femoral arteries, the Respondent sent samples of the arteries to the pathologist for evaluation. The pathologist report indicated that the arteries were "normal." Parenthetically it should he noted that the "complaining witness," Mrs. Fiore, has been found to exhibit symptoms of diabetes mellitus. Her testimony was somewhat evasive concerning the degree to which she may suffer from this malady, which can have a detrimental effect on the vascular system. In any event, when working first on the left leg, the Respondent elected to resect back along the artery for approximately a half-inch on each side of the wound and after that resection, to repair the femoral artery with the insertion of a 6 millimeter gortex graft. Likewise, with regard to the right leg, the Respondent found the sutures would not hold in the damaged artery (which was of a "cheese-like" consistency). He therefore performed a similar resection and insertion of a 6 millimeter gortex graft to repair the injury. The surgical procedure was then successfully concluded. Post-operatively the patient encountered some complications involving infection in the groin area, requiring two additional admissions to Fort Myers Community Hospital. Subsequently, she was transferred to Methodist Hospital in Houston, Texas, where she underwent two additional surgical procedures. The Petitioner presented the opinions of two expert witnesses, Dr. Alexander Braze and Dr. E. William Reiber. Dr. Braze's expert opinion is predicated on the review of Mrs. Fiore's office records from the Respondent's office, the hospital charts for her three admissions to Fort Myers Community Hospital, and summaries of her two admissions to the Methodist Hospital in Houston, Texas. His opinion is not based on any examination of the patient involved. Dr. Braze thus opined that because of the previous surgery on the greater saphenous vein, bilaterally, there would be obvious and considerable scarring and scar tissue in the subcutaneous area which would distort and conceal the individual anatomical structures. He himself has never nicked a femoral artery while doing a vein-stripping operation but, although he acknowledges it is an "uncommon complication, he has heard of it occurring. He was unable to render an opinion concerning whether or not the operation was performed properly because this was not a typical vein ligation and stripping procedure, due to the presence of extensive scar tissue, and resulting difficulty involved. The dense scar tissue precluded identification of the structures in the area of the surgical incision and meant that the Respondent had to proceed slowly and very meticulously with a careful dissection, deviation from which careful procedure could cause difficulty. The doctor's procedure was slow and meticulous. The procedure (for both legs) took approximately four hours. Although the Respondent proceeded with care, he nicked the arteries anyway. Dr. Braze could not state that such a complication, albeit uncommon, constituted a departure from standards normally recognized in the medical community. With regard to the doctor's judgmental decision to proceed to the right leg after nicking and repairing the artery in the left leg and completing the vein stripping procedure in the left leg. Dr. Braze opined that he was acting as a reasonable physician in proceeding to the other leg since he had already corrected the initial injury, especially since it was the leg in which she was having her chief complaints. In any event, Dr. Braze was unable to render an opinion as to whether or not the procedure up to the point of nicking the artery was properly or improperly done, although he acknowledged that the lengthy time taken to perform the total procedure indicates that the doctor was proceeding slowly and with greater than normal difficulties. In any event, after the arteries were nicked, the procedure followed by the Respondent was excellent and the repair work was competently and efficiently performed. Dr. Reiber, Petitioner's other expert witness, testified by deposition, which was stipulated into evidence. His expert opinion was based on a review of the deposition of the Respondent, the Fort Myers Community Hospital records of the patient, and the depositions of the patient, Betty Fiore, Arnold Flare and Quillen Jones. Additionally, he reviewed the records dealing with Mrs. Flare's treatment in Houston, Texas. He thus opined that the Respondent made two technical errors when he injured the arteries in each leg and he felt that it was an error in judgment to have performed the procedure on the right leg after having encountered difficulty in the initial procedure on the left leg. He was unable to opine however, that the treatment rendered the patient by Respondent fell below the appropriate standard of care accepted by similar physicians in the community. Moreover, he also opined that the Respondent's treatment after nicking the arteries affirmatively met the standard of care for reasonably prudent physicians in such circumstances. The expert witnesses presented on behalf of the Respondent were Drs. Peter M. Sidell and Luis A. Ruilova. Both witnesses opined, in effect, that, given the obesity of the patient and the difficult surgical process that alone entailed, coupled with the significant involvement of scar tissue in the area of the incision, that the complications associated with this procedure could occur in the hands of even the most renowned surgeon. The fact that the Respondent experienced these complications does not render his practice in this regard to be below the standard of care for vascular surgeons in that community or area of practice. They further opined that it is a matter of personal judgment on whether to proceed to the other leg after encountering these difficulties. A reasonable judgment would have been to explore the groin area on the other side, after accomplishing repair of the first injured artery, which was done. The initial arterial injury having been repaired in a successful manner, both of the Respondent's experts opined that, the patient then being stabilized, the Respondent was justified in proceeding to the other leg and performing the procedure on that side. The main purpose of the operation was to remove the veins of the patient since the patient was symptomatic with varicosities. It therefore would be poor judgment to simply repair the nicked artery and proceed no further, since the symptomatic vein would remain uncorrected. In short, both experts for Respondent opined that neither the vein-stripping procedure, the repair of the damaged arteries nor post-operative management for which Respondent was responsible were performed in a manner below the appropriate standard of care of reasonably prudent physicians in the community. Thus, although the patient unfortunately experienced difficulties during a procedure involving the accidental nicking of her femoral arteries and, after the grafts repairing those injured arteries were performed, later suffered an infection at the operative site necessitating further hospitalization, no expert witness could describe the treatment and care afforded this patient as being below the appropriate standard of care exercised by a reasonably prudent physician performing such vascular surgical practice in the Fort Myers community or area. The Respondent has never encountered this difficulty either before or since this occasion in his practice, which is characterized by frequent vascular surgical procedures. Additionally, Dr. Ruilova established that the nicking of the femoral arteries during such a procedure, although not a common occurrence, is well documented in the literature and not at all unheard of. Indeed, Dr. Ruilova, when assisting a distinguished surgeon who was chief of surgery at the Mayo Clinic at the time, observed that expert surgeon nick a femoral artery in a vein- stripping procedure on two occasions. Finally, it is noted that the Respondent's practice has been characterized by a high level of professional expertise, competence and compassion in caring for his patients, both before and since the occasion in question. He has never before been subjected to disciplinary action.
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, therefore RECOMMENDED that a Final Order be entered by the Board of Medical Examiners dismissing the complaint in its entirety. DONE and ENTERED this 11th day of October, 1984, in Tallahassee, Florida. P. MICHAEL RUFF 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 11th day of October, 1984. COPIES FURNISHED: Barbara K. Hobbs, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301 Patrick Geraghty, Esquire HENDERSON, FRANKLIN, STARNES & HOLT Post Office Box 280 Fort Myers, Florida 33902 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
Recommendation Based on the foregoing findings of fact and conclusions of law, it is recommended that the Board of Medical Examiners enter a final order dismissing the charges against Dr. Santos on the merits and with prejudice. DONE and ENTERED this 30th day of March 1984, in Tallahassee, Leon County, Florida. J. LAWRENCE JOHNSTON Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 FILED with the Clerk of the Division of Administrative Hearings this 30th day of March 1984.
The Issue The issues in this case are whether Respondents performed a wrong procedure on patient C.C., as set forth in the second amended administrative complaints, and if so, what is the appropriate sanction.
Findings Of Fact The Department of Health, Board of Medicine, is the state agency charged with regulating the practice of medicine in the state of Florida, pursuant to section 20.43 and chapters 456 and 458, Florida Statutes. At all times material to this proceeding, Respondents were licensed physicians within the state, with Dr. Kenneth D. Stahl having been issued license number ME79521 and Dr. Eddie Ward Manning having been issued license number ME110105. Dr. Stahl has been licensed to practice medicine in Florida since 1999 and in California since 1987. He has never had disciplinary action taken against either license. Dr. Stahl is board certified by the American College of Surgeons in general surgery, cardiac and thoracic surgery, and trauma and critical care surgery. Dr. Stahl's address of record is 3040 Paddock Road, Fort Lauderdale, Florida 33141. Dr. Manning has been licensed to practice medicine in Florida since May 31, 2011. He has never had disciplinary action taken against his license. On June 23, 2011, Dr. Manning was a resident in general surgery. Dr. Manning's address of record is 1900 South Treasure Drive, Apartment 6R, North Bay Village, Florida 33141. In February 2011, patient C.C., a 52-year-old female, was admitted to Jackson Memorial Hospital (JMH) with a diagnosis of perforated appendicitis. She also had a perirectal abscess. Her records indicate that she was treated with percutaneous drainage and a course of intravenous (IV) antibiotics. She was discharged on March 4, 2011. On June 22, 2011, patient C.C. presented to the JMH Emergency Department complaining of 12 hours of abdominal pain in her right lower quadrant with associated nausea and vomiting. Shortly after her arrival she described her pain to a nurse as "10" on a scale of one to ten. A computed tomography (CT) scan of patient C.C.'s abdomen was conducted. The CT report noted that the "the uterus is surgically absent," and "the ovaries are not identified." It noted that "the perirectal abscess that was drained previously is no longer visualized" and that the "appendix appears inflamed and dilated." No other inflamed organs were noted. The radiologist's impression was that the findings of the CT scan were consistent with non-perforated appendicitis. Patient C.C.'s pre-operative history listed a "total abdominal hysterectomy" on May 4, 2005. Patient C.C.'s prior surgeries and earlier infections had resulted in extensive scar tissue in her abdomen. Dr. Stahl later described her anatomy as "very distorted." Patient C.C. was scheduled for an emergency appendectomy, and patient C.C. signed a "Consent to Operations or Procedures" form for performance of a laparoscopic appendectomy, possible open appendectomy, and other indicated procedures. Patient C.C. was taken to surgery at approximately 1:00 a.m. on June 23, 2011. Dr. Stahl was the attending physician, Dr. Manning was the chief or senior resident, and Dr. Castillo was the junior resident. Notes indicate that Dr. Stahl was present throughout the critical steps of the procedure. Dr. Stahl had little recollection of the procedure, but did testify that he recalled: looking at the video image and seeing a tremendous amount of infection and inflammation and I pulled-–I recall that I myself went into the computer program and pulled up the CT scan and put that on the screen right next to the video screen that's being transmitted from the laparoscope and put them side-to-side and compared what the radiologists were pointing to as the cause of this acute infection and seeing on the laparoscopic video image that that indeed matched what I saw in the CT scan and I said, well, let's dissect this out and get it out of her so we can fix the problem. Dr. Stahl further testified that the infected, hollow organ that was dissected and removed was adherent laterally in the abdomen and was located where the appendix would normally be. He recalled that an abscess cavity was broken into and the infected, "pus-containing" organ that was removed was right in the middle of this abscess cavity. Dr. Stahl also recalled the residents stapling across the base of the infected organ and above the terminal ileum and the cecum and removing it. The Operative Report was dictated by Dr. Manning after the surgery and electronically signed by Dr. Stahl on June 23, 2011. The report documents the postoperative diagnosis as "acute on chronic appendicitis" and describes the dissected and removed organ as the appendix. Progress notes completed by the nursing staff record that on June 23, 2011, at 8:00 a.m., patient C.C. "denies pain," and that the laparoscopic incision is intact. Similar notes indicate that at 5:00 p.m. on June 23, 2011, patient C.C. "tolerated well reg diet" and was waiting for approval for discharge. Patient C.C. was discharged on June 24, 2011, a little after noon, in stable condition. On June 24, 2011, the Surgical Pathology Report indicated that the specimen removed from patient C.C. was not an appendix, but instead was an ovary and a portion of a fallopian tube. The report noted that inflammatory cells were seen. Surgery to remove an ovary is an oophorectomy and surgery to remove a fallopian tube is a salpingectomy. On Friday, June 24, 2011, Dr. Namias, chief of the Division of Acute Care Surgery, Trauma, and Critical Care, was notified by the pathologist of the results of the pathology report, because Dr. Stahl had left on vacation. Dr. Namias arranged a meeting with patient C.C. in the clinic the following Monday. At the meeting, patient C.C. made statements to Dr. Namias regarding her then-existing physical condition, including that she was not in pain, was tolerating her diet, and had no complaints. Dr. Namias explained to patient C.C. that her pain may have been caused by the inflamed ovary and fallopian tube or may have been caused by appendicitis that resolved medically, and she might have appendicitis again. He explained that her options were to undergo a second operation at that time and search for the appendix or wait and see if appendicitis recurred. He advised against the immediate surgery option because she was "asymptomatic." The second amended administrative complaints allege that Dr. Stahl and Dr. Manning performed a wrong procedure when they performed an appendectomy which resulted in the removal of her ovary and a portion of her fallopian tube. It is clear that Dr. Stahl and Dr. Manning did not perform an appendectomy on patient C.C. on June 23, 2011. Dr. Stahl and Dr. Manning instead performed an oophorectomy and salpingectomy. It was not clearly shown that an appendectomy was the right procedure to treat patient C.C. on June 23, 2011. The Department did convincingly show that patient C.C. had a history of medical problems and that she had earlier been diagnosed with appendicitis, had been suffering severe pain for 12 hours with associated nausea and vomiting, that she suffered from an infection in her right lower quadrant, that the initial diagnosis was acute appendicitis, and that the treatment that was recommended was an appendectomy. However, substantial evidence after the operation suggests that an appendectomy was not the right procedure. The infected and inflamed organ that was removed from the site of a prior abscess was not an appendix. After the procedure, patient C.C. no longer felt severe pain in her lower right quadrant, with associated nausea and vomiting. She was discharged the following day and was asymptomatic. It is, in short, likely that the original diagnosis on June 22, 2011, was incorrect to the extent that it identified the infected organ as the appendix. The pre-operative diagnosis that patient C.C.'s severe pain and vomiting were caused by a severe infection in an organ in her lower right quadrant was correct. Surgical removal of that infected organ was the right procedure for patient C.C. If that inflamed organ was misidentified as the appendix before and during the operation, that would not fundamentally change the correctness of the surgical procedure that was performed. The evidence did not clearly show that the wrong procedure was performed. It is more likely that exactly the right procedure was performed on patient C.C. That is, it is likely that an oophorectomy and salpingectomy were the right procedures to address the abdominal pain that caused patient C.C. to present at the JMH emergency room, but that the right procedure was incorrectly initially denominated as an "appendectomy," as a result of patient history and interpretation of the CT scan.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health, Board of Medicine, enter a final order dismissing the second amended administrative complaints against the professional licenses of Dr. Kenneth D. Stahl and Dr. Eddie Ward Manning. DONE AND ENTERED this 15th day of July, 2015, in Tallahassee, Leon County, Florida. S F. SCOTT BOYD 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 15th day of July, 2015.
