The Issue The issues are whether Respondent is guilty of recordkeeping violations of Section 466.028(1)(m), Florida Statutes, and standard-of-care violations of Section 466.028(1)(x), Florida Statutes, in connection with bridgework, implants, and root canals that he performed on a single dental patient.
Findings Of Fact Background At all material times, Respondent has been a licensed dentist, holding license number DN 11262. He is not Board- certified in any areas recognized by the American Dental Association, but he is a fellow, associate fellow, or diplomate with four associations, not recognized by the American Dental Association, devoted to dental implants. Respondent has been licensed to practice dentistry for over 20 years. At all material times, Respondent practiced in Port Charlotte. At one time, his practice grew to six offices employing 13 dentists and 80 employees. During that timeframe, Respondent performed about 100 crowns and bridges per month, endodontics (which includes root canals) on 7-10 teeth per month, and limited periodontics, including 20-30 implants and 2-3 sinus lifts per month. Respondent has been disciplined previously. In Nebraska, where he was licensed to practice dentistry, Respondent's license was suspended in 1989 upon his conviction for a felony for obtaining a controlled substance by fraud in writing one or more prescriptions, ostensibly for his father, so that Respondent could satisfy his chemical dependency. The Board of Dentistry consequently imposed discipline the following year for this offense (or the suspension arising from it), suspended Respondent's Florida license for one year, and required him to attend the PRN program for impaired practitioners. In February 1995, the Board of Dentistry imposed discipline against Respondent for his violation of the applicable standard of care by failing to diagnose periodontitis prior to seating crowns. The Board imposed a $3000 administrative fine and required Respondent to attend the PRN program and complete 35 remedial continuing education hours. Two years later, the Board of Dentistry imposed discipline against Respondent for his failure to pay the fine. The Board imposed a $500 administrative fine and issued a reprimand. In February 2002, the Board of Dentistry imposed discipline against Respondent for his violation of the applicable standard-of-care and recordkeeping requirements by failing to diagnose and treat periodontitis or recording required exams prior to seating a bridge and crowns and failing to document examinations and test results. The Board imposed a $6000 administrative fine and required Respondent to attend 60 hours of continuing education. In December 1993, evidently in connection with the acquisition of an existing practice, Respondent acquired W. C. as a patient. W. C. was a cost-conscious, aging man who wanted to preserve his natural teeth. Respondent treated him for about ten years and often acceded to W. C.'s requests for reduced pricing for specific procedures. The relationship ended only when Respondent insisted that W. C. pay off a balance that he had agreed to pay. Over the course of their professional relationship, which included about 120 visits, Respondent wrote off $10,000 in charges in an effort to help W. C. control costs. Likely due to pricing sensitivity, W. C. was an episodic patient, rather than a regular patient. This means that W. C. visited Respondent only for relief from particular problems, rather than appearing regularly for cleaning, x-rays, and maintenance. Sometimes W. C.'s refusal to visit the dentist except when he had a problem and his desire to control costs conflicted with his dental needs, which at times became fairly extensive. All of the issues in this case involve, directly or indirectly, Respondent's treatment of two bridges: one in the upper right quadrant and one in the lower left quadrant. The issues require findings addressing the endodontic (root canal) and implant issues, but these issues arose in the larger context of the bridgework issues that W. C. presented. When Respondent acquired W. C., he found bridges already in place in these two locations. A bridge is a fixed prosthesis that supports missing teeth between crowns. Abutment teeth are the retainers; missing teeth are the pontics (or false teeth). The bridge permits the patient to replace missing teeth without having to take them out overnight. Bridges are intended to remain in place for at least five years, although some may remain in place for 20 years. Bridges may be placed temporarily or "permanently." Although some dentists use plastic bridges for temporary placements, Respondent did not do so with W. C. References below to temporary bridges mean that Respondent used temporary cement with no intent, for various reasons, of "permanently" seating the bridge at that time. At the start of the operative timeframe, W. C.'s lower left bridge supplied a pontic for missing tooth number 19, tooth number 17 was missing, and tooth number 18 was a blade implant. On the other side of the pontic were teeth numbers 20 and 21. The presence of a blade implant confirms the age of the lower left bridge, as this type of implant was not typically in use after the 1980s. At the start of the operative timeframe, the upper right bridge supplied pontics for missing teeth numbers 3, 4, and 5. Prior to 1996, a predecessor to this bridge used natural teeth numbers 2 and 6 as abutments. However, in early 1996, Respondent extracted tooth number 2, replaced it with an implant, and installed a new bridge that used the implant at the site of tooth number 2 and teeth 6 and 7 as abutments. In May 1997, when W. C. returned with a loose upper right bridge, Respondent's notes state that he advised W. C. that he needed an implant and performed only palliative treatment. In June 1997, Respondent performed a root canal on tooth number 6, installed a temporary bridge, and later installed a new permanent bridge in the upper right quadrant. Petitioner's expert witness, Dr. Harold Haering, testified that, by July 24, 1997, Respondent extended this bridge to abutment tooth number 8. This is borne out by the note for that date, as well as the notes for October 27, 1997, and July 23, 1998. Some more remote history is available for both these bridges. The record contains dental records for W. C. as far back as September 1974, at which time he had periodontal surgery for teeth numbers 3 through 8. In November 1974, W. C. received a bridge for teeth numbers 4 through 7--a precursor of the upper right bridge at issue in this case. Five years later, the dentist treating W. C. recommended that the upper right bridge be remade after periodontal surgery to tooth number 5. He placed a new upper right bridge in August 1979 and performed a root canal on tooth number 4 in May 1980. In April and May 1981, the dentist placed another bridge, although his notes prevent identifying where. In June 1982, after performing the root canal on tooth number 21, as noted above, the dentist removed the lower left bridge due to decay in tooth number 18. The dentist continued to treat the teeth at the lower left bridge through 1982, removing and recementing the bridge as needed. In January 1983, the dentist discovered a cracked root in tooth number 4. He removed the upper right bridge and then extracted tooth number 4. Likely, dental records are missing from the record for the next five years because, in mid-1988, the records restart with the removal of sutures at teeth numbers 2-5. The records note that this bridge still suffers from mobility. A few months later, the dentist had to remove the upper right bridge again and take new impressions. In mid-1989, the lower left bridge failed, as pontics at sites 18 and 19 separated. At this time, the dentist replaced the lower left bridge. Respondent began to see W. C. in December 1993. Still prior to the operative timeframe, on February 15, 1995, after noting that the prognosis for tooth number 2 was guarded to hopeless, Respondent performed a root canal on this tooth. One year later, Respondent sectioned the upper right bridge and, as noted above, placed an implant at site number 2. In September 1996, Respondent prepared a bridge from teeth sites or numbers 2-7, using 2, 6, and 7 as abutments. After a couple of trials, Respondent cemented the permanent upper right bridge on November 5, 1996. The upper right bridge was rechecked for looseness in May and June 1997, at which time Respondent removed the bridge to perform a root canal on tooth number 6 and prepared a temporary upper right bridge. On July 24, 1997, Respondent prepared tooth number 8 for inclusion in the upper right bridge, which had previously stopped at tooth number 7. The temporary upper right bridge broke on August 6, 1997, at tooth number 6. A week later, Respondent tried in the permanent upper right bridge, but found it needed additional porcelain to the pontic area and took new bite impressions. His notes reflect that he would deliver the bridge after August 28, 1997. On September 3, 1997, Respondent had to send the upper right bridge back to the lab for more porcelain to the occlusal surface and recemented the temporary bridge, which had broken and presumably was repaired again. On October 10, 1997, Respondent cemented the permanent upper right bridge and adjusted it two weeks later. On October 27, 1997, Respondent again recemented the upper right bridge, noting that he was going to submit to W. C.'s insurer a request for pre-approval of a sinus lift in the upper right quadrant. This note states that Respondent was not going to permanently cement the upper right bridge (presumably, again) until he received a response from the insurer. On January 6, 1998, W. C.'s temporary upper right bridge was loose, and Respondent recemented it. For the first time in nearly nine years, based on the notes in the record, attention was also focused on the area of the lower left bridge. Respondent noted pockets of 4-5 mm at tooth number 20. Scaling removed a large seed hull from the vicinity of teeth numbers 20 and 21. On June 10, 1998, W. C. visited Respondent with complaints of sensitivity in the area of the lower left bridge. Respondent took periapical and bitewing x-rays of tooth number These x-rays, which are part of the dental records, justify the root canal for tooth number 20 that Respondent proposed, if the tooth were to be saved for use in the bridge, which was W. C.'s desire. Respondent's notes reflect that he scheduled a root canal for tooth number 20 on the next office visit. A root canal may be called for due to irritation or infection in the tooth's pulp. To perform a root canal, a dentist drills a hole through the crown to access the tooth's pulp and nerves, removes the pulp and nerves for disinfection, fills the resulting cavity, and reseals the tooth. The intent is to clean out the area to the far end of the root, which is called the apex. Overinstrumentation of the cavity or overfilling of the cleaned-out cavity may result in fill escaping beyond the tooth's apex. Underinstrumentation of the cavity results in fill failing to reach to the tooth's apex. On July 1, 1998, Respondent performed a root canal on tooth number 20. Respondent cut a hole in the crown that had already been placed on the tooth and proceeded to clean out and disinfect the interior of the tooth. After he was finished, he placed composite fill to reseal the tooth. Respondent completed the root canal in this single visit. His records adequately record the procedure. Although Respondent had taken intraoperative x-rays that revealed the location of the endodontic cleaning instrument--a file--relative to the apex of tooth number 20, the post-operative x-ray revealed that the fill extended beyond the apex of the tooth almost 3 mm. This means that the fill extended beyond the tooth and into the bony area surrounding the tooth. Dr. Haering testified with evident conviction that the standard of care requires fill to the apex, but not beyond. Dr. Haering testified that the standard of care permits the fill to end 0.5 mm short of the apex. He noted that the standard of care is not violated by an apical puff, in which cement may spiral out during application beyond these limits, but added that this case is not an example of an apical puff. Dr. Haering explained that fill past the apex much more often than not will create sensitivity and will require correction. He testified that "every clinical exam" administered to dental students requires zero extrusion of fill past the apex. The dental records do not reveal any post-operative instructions. Dr. Haering stressed the importance of such instructions after this procedure, more than any other in this case, because of the likelihood of pain from the extrusion of the fill past the apex. Dr. Haering did not find fault with Respondent's practice of performing a root canal and "permanently" sealing it in a single visit. One week later, W. C. returned to the office, complaining of pain at the site of tooth number 20. Respondent reopened the root canal and recleaned the area, although nothing suggests that he found it necessary to readdress the extent of the fill. Respondent applied xylocaine in the cavity and temporarily resealed it until W. C. could return on July 15 for further treatment. He also prescribed an antibiotic and a painkiller. During this visit on July 8, Respondent noted that the upper right bridge was loose. On July 15, W. C. returned to the office and presented again with complaints of pain. However, the notes reveal a loosened lower left bridge, so it is unclear whether the recently treated tooth or the lower left bridge was causing the pain. Unable to remove the bridge, Respondent had to cut it out. He then removed the temporary fill for tooth number 20, rechecked the tooth, and completed the endodontic treatment of this tooth by placing permanent fill in the cavity. During the same visit, while the bridge was off, Respondent also retreated a root canal previously done on tooth number 21, which appears not to have been retreated since it was originally done in 1982. Respondent temporarily sealed the cavity in tooth number 21 and permanently resealed it during an office visit two weeks later. Respondent prescribed an antibiotic and Motrin. The Administrative Complaint alleges that Respondent inadequately shaped and improperly filled the cavity left after the root canal of tooth number 21. During the operative timeframe, Respondent did nothing more than clean out the existing cavity left by the previous root canal, and nothing suggests that Respondent extended the cavity in tooth number 21 beyond the tooth's apex or that he overfilled or underfilled this cavity. Dr. Haering testified that a postoperative x-ray of tooth number 21 revealed that the fill in that cavity did not extend to the apex, although he fails to specify by how much the fill was short. He testified that the applicable standard of care requires filling to the apex. However, as noted above, when testifying about the root canal of tooth number 20, Dr. Haering conceded that 0.5 mm short is acceptable, and a dentist would always want to be short rather than long with the fill. From an endodontic perspective, Petitioner has failed to make a standard-of-care case against Respondent for his retreatment of tooth number 21. Nothing suggests that he did any more than re-clean the preexisting cavity left after a root canal performed many years prior to the operative timeframe. Nothing suggests that Respondent underfilled the cavity, such as by leaving a gap, nor does clear and convincing evidence establish that leaving the fill short--by whatever amount it was short in tooth number 21--would violate the applicable standard of care. From an endodontic perspective, the standard-of-care case as to tooth number 20 is closer. Respondent probably overinstrumented the cavity and clearly overfilled the area past the apex. However, post-operatively, Respondent treated the pain at the site during the July 8 visit when he removed the permanent fill, injected a painkiller, and placed temporary fill in the cavity, as well as prescribing an antibiotic and painkiller. Although Respondent still complained of pain at the follow-up visit on July 15, it is at least as likely that the cause was the loosening of the lower left bridge, given the fact that Respondent did not retreat the endodontics and the records reveal no more complaints of pain in this area in the ensuing months. It appears that Respondent successfully treated tooth number 20, whose failure, years later, is more likely due to the failure of the blade implant at site 18 than to this root canal. In light of these developments, as well as Dr. Haering's inconsistency as to whether a short fill necessarily violates the standard of care, the testimony of Respondent's expert witness, Dr. Robert Fish, as to overfills is entitled to greater weight, at least as to whether an overfill or underfill is, in itself, a violation of the applicable standard of care. Dr. Fish properly stressed that teeth numbers 20 and 21 lasted for the duration of treatment and their ultimate failure was due to the loss of support of the aged blade implant at site number 18, not due to endodontic failure. This failure occurred two years and nine months after Respondent's endodontic work in July 1998. Dr. Fish's testimony is more persuasive as to the endodontics, although his testimony that tooth number 20 was not overfilled and that intentional overinstrumentation is sometimes required to ensure the removal of all infected material is not credited. For these reasons set forth above, Petitioner failed to prove that Respondent violated the applicable standard of care in the root canal that he performed on tooth number 20. Additionally, Petitioner has failed to prove a dental records violation with respect to these root canals. As Dr. Fish testified, the pre-operative x-rays themselves justify the course of treatment. Contrary to the allegations, Respondent recorded symptoms of pain with respect to both teeth. Contrary to Petitioner's contention, nothing in the record explains why Respondent would have to perform a periodontal exam before doing a root canal on tooth number 20 or revising a root canal on tooth number 21, especially when neither tooth failed until the old blade implant at site number 18--not, as alleged, placed by Respondent--failed nearly three years later. The preoperative x-rays showed adequate bone and no periodontal pathology to suggest any periodontal issues with these teeth prior to the endodontic work that Respondent did. The mobility that later developed in teeth numbers 20 and 21 was due to the ultimate failure of the blade implant at site number 18, which took place long after the endodontic work of Respondent on teeth numbers 20 and 21. The only remaining issue concerning the Root Canal Counts is tooth number 6. As noted above, the allegations pertain to root canal procedures performed on tooth number 6 from 1998 through 2001 or 2002. Respondent performed no such procedures on tooth number 6 during these timeframes. For these reasons, Petitioner has failed to prove the recordkeeping and standard-of-care Root Canal Counts. On July 23, 1998, W. C. presented for a repair of the porcelain on tooth site number 3 in the temporary upper right bridge. Respondent also scheduled W. C. for preparation of a new bridge to replace the lower left bridge that he had had to cut off. On the next office visit, which was July 29, Respondent took a final impression for a new lower left bridge. During this visit, he recemented the temporary bridge into place and, according to the notes, discussed shade and coping options with W. C. On August 4, Respondent recemented the temporary lower left bridge, but, on August 17, he had to return it to the lab after another try-in. Ten days later, Respondent had to recement the temporary lower left bridge. Three days later, on August 30, W. C. returned with the temporary bridge broken, and Respondent repaired it and recemented it. On September 15, 1998, the coping failed, and Respondent returned the lower left bridge with a new occlusal mounting. On October 9, 1998, Respondent cemented the permanent lower left bridge, which remained in place until its removal on February 19, 2001. Dr. Fish testified persuasively that there were no violations of the standard of care during this period. He testified that the notes were sufficient for what was essentially revisionary treatment of pre-existing dentistry in the form of the placement of both bridges. The sectioning of the lower left bridge at the time of the endodontics was merely reflective of the age of the bridge, according to Dr. Fish, and the sensitivity that required the root canal of 20 and retreatment of a pre-existing root canal in 21. For the upper right quadrant, where Respondent had placed a permanent bridge in October 1997, he had to recement the bridge in January and again in July and then repair it later in July when a pontic broke. But there were no more problems with this bridge in 1998. It is true that in 1997, prior to the operative timeframe, this bridge suffered more failures, but the first two loosenings--in May and June 1997--appear to be related to problems with tooth number 6, prior to its root canal. Later problems with loosening and breakage involved the temporary, except for one recementing of the new permanent on October 27, 1997. Significantly, Respondent attached to the notes for this visit the need to obtain pre-approval from W. C.'s insurer for a sinus lift, which, as described below, is necessary to permit the placement of implants in an area where the bony area was insufficient for implants. For the lower left quadrant, where Respondent had performed the root canal and root canal retreatment described above, there were two or three recementings of the temporary lower left bridge that Respondent placed after he had to remove the pre-existing lower left bridge to deal with teeth numbers 20 and 21. The additional work consisted of taking impressions for a new bridge, trying it on for size, and fixing breaks in the temporary lower left bridge--all ending with the placement of the permanent lower left bridge on October 9, 1998. After delivering the permanent lower left bridge, the next time that W. C. visited Respondent's office was on February 19, 1999, for full-mouth x-rays and, three days later, for a periodontal screening. The x-rays revealed some caries under the upper right bridge. During the cleaning that took place on February 22, W. C. declined Perioguard, a medicated rinse for gum health. This is a relatively inexpensive way to facilitate healthy gums and suggests that W. C. may have been reluctant to assume his share of the responsibility for maintaining good dental health. A note on March 23, 1999, states that W. C.'s physician recommends postponing treatment due to a heart problem. The postponed dental treatment is not specified, but it is the sinus lift, for which Respondent had sought pre- approval from the insurer. The sinus lift would require intravenous sedation, which, due to W. C.'s health problems, required clearance from his physician. Thus, this note implies that Respondent continued to recognize that the status quo was not sustainable for the upper right quadrant and that a more- lasting solution required a bone augmentation in order to permit the placement of implants to better secure a fixture in the upper right area. Almost as important as Respondent's recognition of the need for a sinus lift is the timing of it: it does not accompany any failure of the permanent upper right bridge that Respondent had seated in October 1997. Instead, the note confirms that Respondent was aware that the upper right bridge was precarious and needed to be readdressed. Consistent with Respondent's recognition of the need to proceed with a bone augmentation and implants in the upper right quadrant, on June 9, 1999, W. C. returned to the office because the upper right bridge had fallen out of his mouth while brushing his teeth. The dental note for this visit states that W. C.'s physician advises that the patient cannot undergo intravenous sedation until early September at the earliest. The note concludes with the tentative scheduling of a pre-operative sinus lift followed by an implant. During the operative timeframe, the instability of the upper right bridge was not due, as Petitioner contends, to Respondent's placement of an excessively long and wide post when doing the root canal in tooth number 6 prior to the operative timeframe; the upper right bridge had had problems before that root canal was performed, and the evidence is mixed as to whether this tooth even had an excessively long post--an issue outside of the scope of this case due to the pre-1998 date of service for this procedure. Nor does there seem to have been a problem with the implant at site number 2 that Respondent had placed prior to the operative timeframe. Respondent's expert, Dr. Carl Misch, testified persuasively that the implant served as an acceptable abutment. (Misch deposition, p. 35.) Also, Respondent's placement of an implant at site number 2 is an issue outside the scope of this case due to the pre-1998 date of service for this procedure. During the operative timeframe, the immediate need-- given W. C.'s rejection of removable dentures--was the placement of multiple implants in the upper right area, as Respondent recognized at the time. This is a fact agreed to by Petitioner's expert, Dr. David Clary, (Clary deposition, p. 19.), and Dr. Misch, who succinctly explained: between tooth number two and tooth number six there are no teeth. [B]etween those two teeth, which is basically the last molar on the upper right and the eye tooth on the upper right, this patient is missing three teeth. And as a consequence of that span a good option . . . is to put some implants in that span. However, if you don't have any bone you can't place implants. (Misch deposition, pp. 32-33.) On August 30, 1999, Respondent took another x-ray of W. C.'s mouth. This is the x-ray that Dr. Haering testified was necessary, before undertaking a sinus lift, to determine the thickness of the bone at the intended site of the implant. During this visit, Respondent scheduled W. C. for intravenous sedation and a sinus lift between September 9 and October 19. A sinus lift is a not-uncommon procedure that may be performed by a general dentist to augment bone in preparation for implant surgery. If the patient's sinus drops down too far, it leaves insufficient bony structure to secure the implant, so the dentist moves the membrane of the maxillary sinus and applies a paste derived from freeze-dried bone. The new material is then sutured into place. Eventually, the new material integrates into the adjacent bone, essentially augmenting the available bone to allow, in this case, the successful placement of implants. On October 4, 1999, Respondent removed the upper right bridge and performed a sinus lift in the area of the upper right quadrant. As conceded by Petitioner's expert, Dr. Gerald Laboda, an oral and maxillofacial surgeon, Respondent's notes adequately detail the sinus lift procedure and materials used, although they omit mention of the fact that W. C. bled heavily and had to go to the emergency room for treatment. However, a note one week later states that W. C. was doing well and not in any pain. Obviously, the bleeding that necessitated a visit to the emergency room is a serious matter. Dr. Laboda testified that the medial wall of the sinus is the lateral wall of the nasal cavity, and Respondent "may" have penetrated this wall accidentally during the procedure. Dr. Laboda was ambivalent in opining whether the applicable standard of care requires a general practitioner to conduct a CT scan prior to a sinus lift in order to identify the anatomy of the patient and reduce the chances of an incident during surgery. On direct examination, Dr. Laboda was unable to say unequivocally that the incident would have been avoided with the anatomical information that a CT scan would have yielded. At one point, Dr. Laboda testified that a general dentist must always obtain a CT scan, in addition to x-rays, prior to performing a sinus lift, but then he quickly characterized this statement merely as a recommendation. Some of Dr. Laboda's ambivalence may be explained by the testimony of Dr. Misch on this point. He testified that x-rays alone met the standard of care and a CT scan exceeded the standard of care, (Misch deposition, p. 66.), but he stated that he has used a CT scan prior to sinus lifts since 2005, even though this practice is still not the standard of care. (Misch deposition, p. 289.) Considering the testimony of both dentists, it appears that the standard of care may be evolving toward the requirement of a CT scan prior to a sinus lift, but did not so require when Respondent performed the sinus lift in 1999. Additionally, Petitioner's proof on this issue was not helped by the refusal of Dr. Laboda to accept Respondent as his peer in implants, suggesting that Dr. Laboda may not be an especially good source of generally prevailing peer performance, and the refusal of Dr. Haering, Petitioner's lone witness who was a general dentist, to opine as to the sinus lift. Likewise, the records justify the course of the treatment in terms of the sinus lift. The need for this procedure is reflected in the records, including the x-rays, which revealed that implants could not be placed unless the bone was augmented. The other notes justifying this course of treatment have already been detailed above. On February 7, 2000, after giving the bone augmentation time to stabilize, Respondent placed an implant in site 3 and an implant in site 4, according to Dr. Clary's interpretation of the record, which is credited. There does not appear to be any real issue with the placement of these implants, which, surprisingly, works somewhat to the disadvantage of Respondent as to recordkeeping, for the reasons set forth below. Dr. Misch testified that, judging from the x-rays, the placement of the implants was acceptable. (Misch deposition, p. 294.) Dr. Laboda testified that the placement of the implants did not violate the applicable standard of care, and he could not opine as to why any implants failed (if, in fact, they did), although he attributed his inability partly due to Respondent's records, which he deemed inadequate. Respondent also replaced the temporary upper right bridge at this time, but his main focus was, of course, on the two new implants. An x-ray on February 29 disclosed that "everything [was] healing well." However, on March 23, a note written by someone other than Respondent states that x-rays were taken and tissue was growing around the bridge, but W. C. needed to return to the office to see Respondent "to have removed"-- apparently, referring to the implants, but possibly the bridge. Four days later, the same person wrote that the bridge was removed, revealing 6 mm pockets around the "implant," although the pockets were around both implants. Without further analysis in the records, Respondent removed the implants. Based on the dental records, the removal of the implants seems to have simply happened. The finding of 6 mm pockets, without more, explains nothing. The placement of the implants was, as noted above, unremarkable. Dr. Laboda explained that 6 mm pockets are not necessarily pathological, and the sole reason for removing the implants is mobility, about which Respondent's notes state nothing. Dr. Laboda added that six-week implants are still integrating into the bone, so concern with these pockets should dictate nothing more than a trimming of the gum around the implants, a procedure known as a gingivalplasty. When asked why a dentist would remove implants with 6 mm pockets, Dr. Misch, acknowledging that some dentists would repair them, never addressed why this condition would justify removal; he merely addressed what other dentists would do. (Misch deposition, p. 296.) Dr. Fish's testimony is unpersuasive on this point. He testified that diagnosis was ongoing--evidently confusing findings of pockets with the diagnosis of a problem requiring the removal of the implants and, more importantly, with careful analysis of the course that the patient was taking with the implants. Dr. Fish also tried to justify the scant records concerning the removal of the implants based on the "fact" that the treatment plan was based on the presentation of an episodic problem. This clearly misses the mark: Respondent had been trying to initiate a treatment plan for the upper right bridge for two years and finally, with the clearance obtained from W. C.'s physician, was able to execute the plan. The best that Dr. Fish could offer, after looking at an x-ray, was that one implant "might" start to travel--hardly justification for the removal of the two implants after only six weeks. Dr. Fish's testimony that Respondent was diagnosing W. C. continuously following the implants, implying some insight on Respondent's part as to why he thought that the implants had failed or were failing, contradicts the more persuasive testimony of Dr. Misch, who stated that, typically, a dentist does not know why an implant fails. (Misch deposition, p. 68.) Respondent testified that he removed the implants due to the presence of the 6 mm pockets. He testified that the problem was not so much periodontal as that the surgical site needed more time to heal. (Respondent deposition, pp. 40-41.) This testimony suggests that the implants may have been placed prematurely, or at least that Respondent thought so. Either way, Petitioner has proved a standard-of-care violation as to the removal of the implants. If Dr. Laboda's testimony were credited over Respondent's testimony on the status of the implants at the time of their removal, and it is, Respondent violated the standard of care by removing these implants prematurely and subjecting an elderly patient unnecessarily to the trauma of the removal and, as noted below, replacement of these implants a short time later. If Respondent's testimony were credited on the status of the implants at the time of their removal, and it is not, Respondent violated the standard of care by placing the implants prematurely. In this instance, the records are silent as to the reason for the removal of these two implants because there was no good reason to do so at that time. Thus, Petitioner has proved the standard-of-care Implant Count. Petitioner has also proved the recordkeeping Implant Count in the removal of the implants. As Dr. Laboda testified, when admitting that he could not explain the failure of the implants, the problem lies in the scant information contained in Respondent's records. Records justifying the course of treatment would detail the case sufficiently so it would be clear whether the implants were placed prematurely or, as is found, they were removed prematurely. If the pockets alone warranted the removal of the implants, Respondent needed to document this fact to justify their removal, rather than treatment of the gums, and to guide his or another dentist's attempt to place implants in the upper right quadrant of W. C.'s mouth in the future. If the implants were mobile, Respondent needed to state this fact, again for the same purposes. On May 8, 2000, using local anaesthetic, Respondent added bone to the area where he had performed the sinus lift and had placed and later removed the two implants described above. Checking them for the first month at two-week intervals and then one month later, on July 5, 2000, Respondent noted that the tissue was healing fine. Later in July, as well as in August, September, and October, Respondent had to repair the temporary bridge, as the permanent bridge still awaited the successful seating of two implants at sites 3 and 4. On November 13, 2000, Respondent again placed implants at sites 3 and 4. He noted the procedure as he had the previous procedure. These implants performed fine and integrated into the surrounding bone as intended. After a series of fittings, Respondent delivered the permanent fixtures for the upper right quadrant on May 22, 2001. Acknowledging the stability problems with the upper right bridge in its past configuration--although failing to mention this analysis anywhere in his notes--Respondent chose not to try to use a single bridge. Toward the back, he splinted together implants at sites 2, 3, and 4. Toward the front, he cantilevered a pontic at site 5 off natural teeth 6, 7, and 8. Petitioner's expert, Dr. Clary testified that he was "very fine" with the design for 2, 3, and 4. (Clary deposition, p. 123.) Dr. Clary expressed concerns about the cantilever bridge that extended from abutment teeth numbers 6, 7, and 8 to the pontic at site number 5. (Clary deposition, p. 124.) In particular, Dr. Clary questioned the length of the post in tooth number 6, for which, as noted above, Respondent had performed a root canal prior to the operative timeframe. (Clary deposition, p. 125.) Ultimately, Dr. Clary's concerns about the cantilever bridge are unpersuasive. The contemporary reader of Respondent's notes probably would not have known that Respondent delivered two fixtures on May 22. Prior to May 22, the lone indication of two fixtures is a brief note, dated May 2, that states that Respondent repaired the broken upper right bridge by cementing 6-8 with one bond and 2-4 with a different bond. More significantly is the omission of any findings or analysis supporting the choice to divide the upper right bridge into two fixtures. The notes continue to refer to a single "1-8" structure on May 14 during a try-in, May 16 concerning a production process, and May 22 at the time delivery. After the hint contained in the May 2 note, the next mention of a shorter fixture is a note on June 4 referring to a "6-7" bridge, evidently for delivery by the next visit, at the end of a note describing a porcelain failure of the crown for tooth number 6. Also, on June 26, the notes state that a metal fracture--not the fault of Respondent--occurred on the "bridge" "2-4." Even after these references, a note on August 6 refers to the delivery of "2-8." The notes are consistent with one of two situations, both of which lead to a recordkeeping violation in terms of the bridgework. Perhaps Respondent delivered another iteration of the 2-8 bridge on May 22 and, after encountering one more failure of this design only a few days later, abruptly decided to go with two fixtures. More likely, Respondent actually delivered two fixtures on May 22, and the recordkeeping was slow to reflect this fact. Either way, the records are devoid of analysis supporting the treatment choice of two fixtures. After W. C. switched dentists, he visited Dr. William McKenzie, a periodontist, for a consultation in January 2003 after presenting for x-rays in December 2002. Called by Petitioner as a fact witness, Dr. McKenzie testified that he found that the upper right bridge was "hopeless," (McKenzie deposition, p. 8.), at least partly due to the fracturing of tooth number 6. (In subsequent questioning, Dr. McKenzie clarified that he was referring to the cantilever bridge on teeth numbers 6-8. (McKenzie deposition, p. 13.)) He added that he could recall no other problems in W. C.'s mouth, except for tooth number 16, which lacked bone around it. (McKenzie deposition, pp. 13 and 30.) In particular, Dr. McKenzie saw no problem with the implants. (McKenzie deposition, p. 34.) Dr. McKenzie testified that these problems could have arisen "very, very quickly." (McKenzie deposition, p. 15.) Dr. Misch testified that about ten percent of teeth that undergo root canals suffer problems within eight years (Misch deposition, p. 39), commonly in the form of fractures (Misch deposition, p. 40). When the tooth that has undergone a root canal is used as an abutment for a bridge, the fracture risk may increase four-fold. (Misch deposition, p. 40.) The performance of the upper right bridge and, later, the cantilever bridge, was probably undermined by several factors. First, W. C. would not accept a removable denture, and he may not have been willing to undertake the growing responsibilities that he would have to shoulder to maintain his remaining natural teeth in this area, as the incidence of certain dental problems, like caries, would suggest. Second, teeth numbers 6-8 may have had anomalies of crown height and root length, which combined with the next factor to cause problems. Third, W. C., a tooth grinder, likely placed large loads on the teeth at night, which would be especially problematic during the period, after work on the teeth, that they were to remain unloaded. On this record, though, any problems in the performance of the upper right bridge and, later, the cantilever bridge cannot be attributed to Respondent, so Petitioner has failed to prove the standard-of-care Bridgework Count, at least as to the upper right quadrant. However, Respondent's recordkeeping concerning the upper right bridge failed to justify the course of treatment in one respect: the decision to separate the single fixture into two. When considered from the perspective of Respondent's records, this action has the same deus-ex-machina quality to it as the removal of the implants from sites 3 and 4 in March 2000: without warning, a seemingly outside force implements surprise treatment choices. As was the case with the implant-removal decision, the decision to place an implant splint and a cantilever bridge cannot be inferred or justified from x-rays or other dental records. There are two distinctions between the abrupt decision to place two fixtures and the abrupt decision to remove the implants. First, the treatment regarding the design of the new fixtures for the upper right quadrant does not represent a standard-of-care violation, but actually reinforces the impression that Respondent had a treatment plan in mind--not on paper--from the start of the operative timeframe, if not before. Second, the notes, apart from x-rays, fail adequately to describe the implant splint and cantilever bridge and rely excessively on inference to establish even the existence of these fixtures. The remaining factual issues concern the lower left bridge. As noted above, Respondent delivered the permanent lower left bridge on October 9, 1998. According to the notes, the next time it was addressed was when it was removed on February 19, 2001, which coincides with the end of the most intensive treatment, described above, of the upper right quadrant and precedes the delivery of the two upper right fixtures, also described above, by three months. Although the handwritten dental records do not indicate why Respondent removed the lower left bridge, a note on January 29, 2001, states that W. C. presented with a tooth ache in the lower left quadrant, and an x-ray taken on the same date revealed an infection around the blade implant at site number (Respondent deposition, pp. 56 and 58.) (Respondent's response on page 58 that the blade implant was placed in 1998 was either inaccurate or inaccurately transcribed given the era in which blade implants were used and Respondent's interrupted testimony, on the next page, suggesting that another dentist placed this implant, which, if 1998, would have been when Respondent was treating W. C. and routinely doing implants.) On February 19, Respondent placed a temporary lower left bridge and prepared for the production of a new permanent bridge. He also prepared a post and core for tooth number 20. On March 20, Respondent cleaned up the area around the blade implant at site number 18 and placed some bone material in the area to build it up to better secure the blade implant. After doing this work, on the same day, Respondent cemented the temporary lower left bridge. Respondent recemented the temporary lower left bridge the day after W. C. was hospitalized for "lethargy," according to a note on March 27, 2001. On April 9, the records note that the tissue looked good. On April 23, Respondent again recemented the temporary lower left bridge. Initially misreading his own notes, Respondent testified that he did the final impression for the lower left bridge on April 23 when he actually did the final impression for the upper right bridge/fixtures on that date. (Respondent deposition, pp. 61- 62.) When advised of this error, Respondent testified that he did eventually replace the lower left bridge with a permanent fixture, but it is not reflected in the notes. (Respondent deposition, p. 62.) This is an odd answer because the notes actually document the delivery of the permanent lower left bridge on July 8, 2002. After April 23, the next reference to the lower left quadrant in the notes is June 26, 2001, when Respondent had to recement the temporary lower left bridge. On August 20, 2001, the notes indicate that Respondent "attempted to restore 20, 21 guarded." Evidently, the attempt was short-lived and the deterioration from guarded to hopeless was quick because the same note--confirmed by Respondent as accurate (Respondent deposition, p. 63)--is that he extracted teeth numbers 20 and 21. On August 27, 2001, W. C. returned to the office. Respondent recommended a treatment plan to include the placement of four implants in the lower left quadrant. Due to cost considerations expressed by W. C., Respondent only placed three implants, which took place on October 31, 2001. The October 31 note adequately describes the procedure. The implants integrated into the surrounding bone after a brief infection shortly after their placement. On April 17, 2002, Respondent restored the implants and placed a temporary lower left bridge. On May 8, 2002, Respondent took a final impression for a bridge from site number 18 to site number On July 8, 2002, Respondent delivered the permanent lower left bridge. The professional relationship ended with a note on July 31 that W. C. agreed to pay the balance in three weeks; he later failed to appear for an appointment on January 30, 2003. Of course, by this time, he had presented for x-rays and been seen by Dr. McKenzie on a consultation in connection with dental work that W. C. was undertaking with another general dentist. The recordkeeping fails to justify the course of treatment as to the removal of teeth numbers 20 and 21. Respondent could explain orally that these two teeth became mobile when they lost the support they required from the blade implant at site 18, but nothing in the records mentions this fact, and, from the perspective of the records, these two extractions just seem to happen. However, Petitioner already proved the recordkeeping Bridgework Count in connection with the treatment decision to divide the single upper right bridge into two fixtures, so this additional violations may only have a bearing on the penalty. The lone count not yet proved, but still at issue in connection with the lower left bridge, is the standard-of-care Bridgework Count because Petitioner failed to prove this count in connection with the upper right bridge. Dr. Clary testified that he had no problem with the decision to place implants at site numbers 20 and 21; his lone criticism of this treatment is that it did not take place in 1998. (Clary deposition, p. 99.) Nor did he disagree with the placement of the third implant at site number 18. (Clary deposition, p. 100.) Questioning whether the standard of care permits the connection of implants to natural teeth (Clary deposition, p. 100), Dr. Clary conceded that this is a point of controversy within the dentistry profession (Clary deposition, p. 101), implicitly admitting that the standard of care does not prohibit this practice. Dr. Clary conceded that controversy also existed as to the type of connector--ridged or unridged-- that should be used for these implants and natural tooth. (Clary deposition, p. 102-03.) In sum, Dr. Clary did not try to make much of a case as to the standard of care concerning the lower left bridge, especially if one accepts the fact that patient resistance precluded the use of a removable denture in this area and that extensive work on the lower left bridge probably had to await completion of the extensive work on the upper right bridge, given W. C.'s financial constraints and the practical problem of ensuring that he could chew on at least one side of his mouth for weeks at a time. Likewise, Dr. Laboda did not fault the placement of any implants; his focus was on the sinus lift and recordkeeping. Thus, Petitioner has failed to prove a standard-of-care violation with respect to the bridgework in the lower left quadrant. Based on the foregoing, Petitioner has proved only the following violations. First, Petitioner proved the recordkeeping Bridgework Count (Count I) concerning Respondent's decision to replace the single upper right bridge with two fixtures in May 2001. This was a good treatment choice. However, Respondent not only failed to document the reasons for this choice or findings that would support this choice; he even failed to identify adequately the treatment choice. Second, Petitioner again proved the recordkeeping Bridgework Count (again, Count I) concerning Respondent's decision to extract teeth numbers 20 and 21 in August 2001. Relying on Dr. Clary's testimony, this was probably a good treatment choice, although Dr. Clary's testimony that this action should have been taken in 1998 is not credited, at least as to the implication that it violated the standard of care for Respondent not to have taken this action earlier. Third, Petitioner proved the recordkeeping Implant Count concerning the sudden removal of the recently placed implants at site numbers 3 and 4 in March 2000. Fourth, Petitioner proved the standard-of-care Implant Count concerning the premature removal in March 2000 of the recently placed implants at site numbers 3 and 4, although the consequences of this departure from the applicable standard of care are slight due to Respondent's immediate addition of more bone, using only local anaesthetic, and successful replacement of implants at these two locations. Aggravating factors are the number of times that the Board of Dentistry has disciplined Respondent, including one case involving a recordkeeping violation; and the presence of three separate recordkeeping violations in this case (although two of them are alleged in the same Bridgework count). Mitigating factors are the lack of danger to the lone patient from, and the lack of severity of, the proved violations; the reversibility of the limited damage that resulted from the lone standard-of-care violation (i.e., the premature removal of the two implants followed by the addition of more bone and successful replacement of two new implants); the number of years that Respondent has practiced; and the time that has elapsed-- eight years--since the last violation, during the last seven and one-half years of which Respondent has not been disciplined.
Recommendation Based on the foregoing, it is RECOMMENDED that the Board of Dentistry enter a final order finding Respondent guilty of Counts I, III, and IV of the Administrative Complaint and imposing the following discipline: $20,000 administrative fine; license suspension until the greatest of 30 days, full payment of fine, or posting of security adequate to the Board for the full payment of fine; passage of the Florida Rules and Laws exam within one year of the Final Order; probation for the greater of five years or until Respondent successfully completes the two-year remedial course described above; and audits every two years to ensure that Respondent is current on his continuing education. As noted above, a suitable restriction on practice would be an effective substitute for the minimum 30-day suspension described above, although the restriction on practice would need to extend longer than 30 days. DONE AND ENTERED this 17th day of June, 2009, in Tallahassee, Leon County, Florida. ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 17th day of June, 2009. COPIES FURNISHED: H. Wayne Mitchell, Esquire Assistant General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Max R. Price, Esquire Law Offices of Max R. Price, P.A. 6701 Sunset Drive, Suite 104 Miami, Florida 33143 Susan Foster, Executive Director Board of Dentistry Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Dr. Ana M. Viamonte, Secretary State Surgeon General Department of Health 4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701
The Issue The issue in this case is whether Florida Administrative Code Rule 64B-3.004(2) constitutes an invalid exercise of delegated legislative authority.
Findings Of Fact In 1971, Personal Injury Protection (PIP) coverage was required to be included in automobile insurance policies and was required to be obtained by anyone operating a motor vehicle in Florida. In general, PIP coverage provides payment for medically necessary treatment, lost wages and funeral expenses incurred by persons involved in motor vehicle accidents. The reasons PIP insurance coverage was made mandatory were to provide for the speedy payment of medical expenses, lost wages and burial expenses that an individual might incur as a result of being injured in a motor vehicle accident and to reduce the amount of litigation involved in recovering such expenses. Responsibility for such speedy payment rested with the various insurance companies involved in writing motor vehicle insurance. Until 1980, the PIP system operated in a reasonably cost-efficient manner. However, fraud and paying for medically unnecessary medical tests or treatment were problems under the PIP system. In the past, at the option of a given insurance company, such unnecessary testing or treatment resulted in payment, denial of the claim, and perhaps litigation for the denied claim. By the mid-1980s, for a variety of reasons, the PIP system became less cost efficient. The average Florida PIP claim rose by 33 percent and the amount of premium per insured vehicle needed to cover PIP claims rose by 35 percent. Such increases led to higher premiums for the driving public, as well as larger numbers of motorists not carrying PIP coverage, estimated to be around 22 percent of Florida drivers. Indeed since 1999, State Farm Insurance Company, one of the largest insurers of motor vehicles, has experienced an average $100,000,000.00 loss per year. In 2001, the Legislature enacted a fee schedule for certain medical services and tests, including a fee for SEMG. The legislature did not limit the number of times a particular service or test could be used. The 2001 legislation did not solve the problems of continued claims and payment for tests or services that were not medically necessary or overutilized. The 2001 legislation also did not solve the problem of the cost ineffectiveness of companies litigating the issue of whether a particular test was medically necessary or overused. Consequently, during the 2003 legislative session, the Florida Legislature enacted Section 627.736(5)(b)6., Florida Statutes, which provides: The Department of Health, in consultation with the appropriate professional licensing boards, shall adopt, by rule, a list of diagnostic tests deemed not to be medically necessary for use in the treatment of persons sustaining bodily injury covered by personal injury protection benefits under this section. The initial list shall be adopted by January 1, 2004, and shall be revised from time to time as determined by the Department of Health, in consultation with the respective professional licensing boards. Inclusion of a test on the list of invalid diagnostic tests shall be based on lack of demonstrated medical value and a level of general acceptance by the relevant provider community and shall not be dependent for results entirely upon subjective patient response. Notwithstanding its inclusion on a fee schedule in this subsection, an insurer or insured is not required to pay any charges or reimburse claims for any invalid diagnostic test as determined by the Department of Health. The statute was intended to relieve an insurance company of the burden of paying for or litigating the medical necessity of diagnostic tests that the Department listed in a to-be- developed rule. There was no evidence suggesting that the Legislature intended the words used in the statute to have any meaning other than their ordinary meanings. In order to implement the statute, the Department commenced rulemaking pursuant to the legislative directive in Section 727.736(5)(b)6. Florida Statutes. As a starting point, the Department asked the insurance industry to provide a list of diagnostic tests that the insurance industry believed should be in the rule. The list contained four tests--Spinal Ultrasound, Nerve Conduction Velocity (NCV) Studies, Somatosensory Evoked Potential, and Dermatomal Evoked Potential. SEMG was not included on the insurance industry’s list. SEMG is a method of measuring the electrical output of muscles through the placement of electrical sensors on the skin. In general, a muscle at rest has a lower amount of electrical activity than a muscle that is being worked or contracted. Similarly, muscle spasms have more electrical activity associated with them than a muscle at rest. On the other hand, muscle contracture, which is the condition of a muscle at rest that has been permanently shortened and generally hardened through some process, has a different level of electrical activity associated with it than with muscle spasms. There are two types of SEMG, used for different purposes. Neither type of SEMG relies on subjective patient input. Static EMG uses a hand-held device with probes as an assessment (or muscle scanning) procedure to take a quick measure of muscle tension. Although in most cases hand palpation of a muscle gives a practitioner all the necessary information needed to diagnose a patient, SEMG can augment hand palpation when palpation is not determinative and help differentiate contraction from contracture. SEMG, also can assist in determining the need for the more comprehensive application of dynamic SEMG and generates a graphic, recorded reading of muscle tension. Dynamic SEMG is used to document and verify injury, to determine if the patient is injured, and, in concert with other diagnostic procedures, establish the level or the extent of injury. Once a treatment plan is developed and implemented, SEMG testing is used to monitor a patient's response to treatment. Dynamic SEMG provides an objective tool to evaluate the function of paraspinal muscles of injured persons, including those involved in motor vehicle accidents. On July 25, 2003, the Department published a notice for a workshop for proposed Rule 64B-3.004 in volume 29, no. 30 of the Florida Administrative Weekly. On August 29, 2003, the Department re-noticed the workshop in Volume 9, no. 35 of the Florida Administrative Weekly. The workshop was held on September 9, 2003. The draft rule presented at the workshop listed the four tests submitted by the insurance industry. The draft rule did not include SEMG. However, based on comments made during the workshop, some of which came from a chiropractic representative of the Florida Chiropractic Association, SEMG was included in the next iteration of the draft Rule. The next public iteration of the rule appeared in a Notice of Proposed Rule published on Friday, November 14, 2003, in Volume 29, No. 46 of the Florida Administrative Weekly. SEMG appeared for the first time in the November 14, 2003 notice. The proposed rule was, according to the Notice, based “[u]pon review of the testimony provided at the workshop, input received from the Boards, written opinions by members of the health care and insurance communities, and literature in support thereof.” The Notice also announced a public hearing for 9:00 a.m. on Tuesday, November 18, 2003. Additionally, the record for submitting information regarding the proposed rule was held open for 21 days after the November 14, 2003, publication date to give interested persons an opportunity to submit information. During the time the record was held open, the Department received some evidence and studies indicating that SEMG was not useful, or at a minimum, unnecessarily redundant in the diagnosis of the type of injuries often incurred in an automobile accident. However, the Department also received some evidence and studies that SEMG was useful in the treatment of such injuries, particularly when bio- feedback is being employed in treatment. Oddly, on December 2, 2003, prior to the official closure of the record, the final rule was transmitted to the Secretary of the Department for signature and approval for filing with the Secretary of State. In due course, the rule was filed with the Secretary of State and became effective on January 7, 2004. Rule 64B-3.004, as adopted by the Department states, in relevant part, as follows: 64B-3.004 Diagnostic Testing. For the purposes of Section 627.736(5)(b)6., F.S. (2003), the Department of Health, in consultation with the appropriate licensing boards, hereby adopts the following list of diagnostic tests based on their demonstrated medical value and level of general acceptance by the provider community: * * * (2) Surface EMG is deemed not to be medically necessary for use in the diagnosis of persons sustaining bodily injury covered by personal injury protection benefits. * * * Specific Authority 627.736(5) FS. Law Implemented 627.736(5) FS. History - New 1-7- 04. The rule only applies to SEMG when used for diagnostic purposes. The rule does not apply to SEMG when used in the treatment of PIP-covered automobile accident victims. Petitioner, Richard Merritt, is a Doctor of Chiropractic, licensed in Florida, Texas, and Alabama. Prior to the adoption of Rule 64B-3.004, Dr. Merritt billed $130,000 to $160,000 per year for SEMG tests. Dr. Merritt has used SEMG in his practice since the 1980s. Thirty-five percent of Dr. Merritt’s patients have been involved in motor-vehicle accidents. Curiously, Dr. Merritt performs SEMG on all of those patients for which PIP insurance generally pays. Again, curiously, only ten percent of his remaining patients have SEMG that may or may not be covered by other insurance. However, the evidence was not clear as to the differences between patients sustaining injuries in motor-vehicle accidents and other non-accident patients. Dr. Merritt suggested that motor-vehicle accident patients generally have more complicated or layered medical histories than patients who have not been involved in motor-vehicle accidents. No evidence was presented on this alleged difference which seems to be a very dubious distinction between patients. The Florida Insurance Council, Inc.; the Property Casualty Insurers Association of America; The American Insurance Association; The National Association of Mutual Insurance Companies; The Florida Automobile Joint Underwriting Association; State Farm Mutual Automobile Insurance Company; Allstate Insurance Company; Government Employees Insurance Company; The Florida Farm Bureau Insurance Companies; Liberty Mutual Insurance Group; First Floridian Auto and Home Insurance Company; and United Service Automobile Association have standing to intervene in this proceeding. Florida Insurance Council, Property and Casualty Insurance Association of America, and the American Insurance Association, all have a substantial number of members affected by the rule. These associations exist, in part, to protect their member's interests in legislative and regulatory matters involving insurance. The subject matter of this rule is within the associations' scope of interest and activity and they are often involved in these types of rule challenges. Intervenor, Florida Automobile Joint Underwriters Association (JUA), is the automobile residual market in Florida. The JUA makes PIP available to high-risk customers and operates as a standard insurance company under its governing statutes and rules. All the individual companies that sought to intervene in this proceeding pay claims under PIP provisions. Both the JUA and the individual companies are directly affected by the rule. The rule affects rates and premiums which are calculated based in part on loss experience. Loss costs are affected by the rule because the rule regulates what must be paid under PIP coverage. Additionally, the rule affects the profits and losses of individual companies. The issue in this case is limited to a consideration of whether the inclusion of SEMG on the “list of diagnostic tests deemed not to be medically necessary for use in the treatment of persons sustaining bodily injury covered by personal injury protection benefits” is an invalid exercise of delegated legislative authority. Accordingly, the place to start is with the language of the statute being implemented. § 627.736(5)(b)6., Fla. Stat. As indicated earlier, there was no evidence that the Legislature intended the words used in the statute to have any meanings other than their ordinary meanings. Thus, by reading the statute, it is clear that the tests to be included in any proposed rule must be “diagnostic tests.” It is undisputed that “diagnosis” and “treatment” in the medical area are different procedures and refer to different aspects of providing medical care to a patient. When used in a medical context, the term “diagnosis” means the art of distinguishing one disease from another or the determination of the nature of or cause of disease or injury, whereas the term “treatment” means the management and care of a patient for the purpose of combating disease or disorder. See Dortland’s Illustrated Medical Dictionary, 27th Ed. (1988) and Stedman’s Medical Dictionary, 26th Ed. (1995). In short, there is a diagnosis phase of medical care wherein a practitioner uses various tests, procedures and historical information to determine the nature, i.e. what the patient’s condition is and/or how severe the condition is, and the cause, i.e. automobile accident or fall, of a given disease or condition. Distinct from the diagnostic phase there is a treatment phase of medical care wherein a practitioner, through tests, therapies, procedures and medicines manages or cares for a patient’s condition. However, in their ordinary usage, the terms “diagnosis” and “treatment” can overlap. In ordinary usage, the term “diagnosis” does not differ significantly from the medical term and means the art or act of identifying a disease from its signs and symptoms. Webster’s New Collegiate Dictionary (1984). The term “treatment” means “the act or manner or an instance of treating someone or something: HANDLING, USAGE.” Id. The term “treat” means to “deal with.” Id. In its ordinary sense, “treatment” has a broader meaning than it does in its medical sense and can include diagnosis. Thus, in this case, the tests referred to in the statute are diagnostic tests used in handling or dealing with a person who has been physically hurt in a motor vehicle accident. Also, by giving the term “treatment” its ordinary meaning the Department has the authority to differentiate between the appropriateness of a diagnostic test used in the medical diagnostic phase and the same test used in the medical treatment phase. In this case, SEMG, especially static SEMG, is used as a test in both the medical diagnosis and treatment phases in dealing with persons injured in a motor vehicle accident. Therefore, it is a diagnostic test that may be considered under the other criteria of the statute. For a test to be included in the rule it must be medically unnecessary, based on a lack of demonstrated medical value and a lack of general acceptance by the relevant provider community and not be dependant for results entirely from subjective patient response. As can be seen, the statute does not deal with the overuse of a given test, but only defines medical necessity by the three criteria listed above. In reality, some types of test overuse may only be determined on a case-by-case basis, since whether a generally or occasionally, medically beneficial test is useful or redundant at a particular time in treatment or diagnosis depends greatly on the reasons the test is being employed. Thus, if a test has a degree of medical value, it cannot be on the list; if a test has a level of general acceptance by the relevant provider community which includes the Doctors of Chiropractic, it cannot be on the list; and if a test is not dependent for results entirely on subjective patient response, it cannot be on the list. The medical value of any test is not related in any way to the manner in which payment for that procedure is made. In that regard, the medical validity of a procedure does not vary as to whether the patient is covered by Workers' Compensation, Medicare, private insurance, or PIP. PIP patients typically have injuries to the connecting soft tissues of their spine as well as injuries to organs and broken bones. Muscles, ligaments, and tendons can be stretched or injured, which can lead to a breakdown in spinal-joint motion or a spinal-joint misalignment. Spinal-joint misalignment may cause interference in the patient's nervous system. Soft tissue and misalignment injuries are routinely the subject of chiropractic care. SEMG is effective in recording changes in the electrical activity of muscles associated with spinal injuries known as vertebral subluxations. Vertebral subluxations are commonly associated with automobile accidents, and are diagnosed and treated by chiropractic physicians. In spinal injuries, there is a depolarization that occurs at the cellular level. Electrical activity is generated at the cellular level and runs down the muscle fiber. SEMG measures the surface manifestation of the amount of electrical activity generated and the depolarizations in the area. The purpose is to measure muscle tension. SEMG is objective and quantitative. It eliminates subjective impressions or input and provides an objective and unbiased assessment of the electrical activity of the patient's paraspinal muscles. It allows a medical professional to distinguish objectively between observed muscle tension that is electrically active, which is associated with spasm, from observed muscle tension that is not electrically active, which is associated with contracture. It is debatable whether SEMG provides no more useful information to a practitioner than information gleaned by hand palpation of the injured area. The problem is that hand palpation can sometimes be inconclusive, especially in regard to determining if a muscle is hard from spasm or contracture. The question is one of over or redundant use of a test. Again that question is not part of the criteria for inclusion of a test in the rule. The criteria only include whether a test can be used by the practitioner to make a valid diagnosis or conclusion. In regard to SEMG, published documentary evidence demonstrates that spasm and contracture share a similar physical manifestation, i.e. the muscle is hard to the touch, and may not be distinguished through palpation and that, in the occasional instances where had palpation is inconclusive, SEMG can differentiate the conditions, and “provide[] an important element of diagnostic information.” Specific to automobile-related injuries, when hand palpation is inconclusive, SEMG has medical value to chiropractic physicians in that it allows the treating chiropractic physician to determine if a patient has an injury or does not have an injury, to quantify the extent of the injury, to monitor the patient's response to treatment, and to assess the point of maximum clinical improvement or maximum therapeutic benefit. While its diagnostic usefulness may be limited to certain situations when hand palpation is inconclusive, the evidence demonstrated that SEMG had some utility in the diagnostic phase of medical care. Therefore, SEMG should not be included in the proposed rule. Dynamic SEMG is also utilized on motor vehicle accident victims. Its primary use is to provide the level of documentation for services rendered a person involved in a motor- vehicle accident required to demonstrate injury, permanency of injury, the need for treatment, and the response to treatment before payment will be made under a PIP plan. Overall, SEMG has advanced as a clinical tool from its earliest, more experimental uses in which no computer support was available, through the time in which the best technology available was the Commodore 64 (or earlier) computer, to today, when advances in technology and understanding have resulted in the elimination of problems of electrical interference, bandwidth filtering and electrode placement, and have resulted in a higher threshold of sensitivity. The evidence in this case demonstrates that SEMG has medical value for use in the treatment of persons sustaining bodily injury covered by personal injury protection benefits. The Department admitted and the evidence showed that some surface EMG techniques may be useful in the treatment of persons sustaining bodily injury in motor vehicle accidents in appropriate circumstances. Based on the admissions of the Department, it is clear that SEMG has a degree of demonstrated medical value. Therefore, its inclusion on the list of medically unnecessary tests is arbitrary and capricious; has exceeded the Department’s grant of rulemaking authority; and has enlarged, modified, or contravened the specific provisions of law implemented. The Department also admitted and the evidence showed that SEMG is not dependent for results entirely upon subjective patient response. Therefore, under the terms of the statute, the inclusion of SEMG on the list of medically unnecessary tests has exceeded the Department’s grant of rulemaking authority and has enlarged, modified, or contravened the specific provisions of law implemented. The evidence also demonstrated that SEMG is generally accepted in the relevant provider community. In 1996, the two primary organizations that represent chiropractic physicians in Florida, the Florida Chiropractic Association and the Florida Chiropractic Society, were asked to develop a set of guidelines to apply to the chiropractic profession. Their work resulted in a report and the publication of the Chiropractic Practice Guidelines and Parameters for the State of Florida (CPG). The CPG was unanimously accepted and endorsed by the Florida Board of Chiropractic on August 22, 1996. The CPG was copyrighted and published by the Florida Chiropractic Association, Inc. and the Florida Chiropractic Society, Inc. in 1997. The CPG is a set of rules or guidelines that a practicing chiropractic physician can follow regarding the treatment of chiropractic problems. The CPG constitutes the consensus agreement of the chiropractic profession on many of the procedures that a chiropractor might provide. The CPG references SEMG both in comparison with needle EMG and as to its own merits. As a comparative matter, the CPG provides that “needle techniques are appropriate for the evaluation of specific muscles, while surface electrodes are appropriate for kinesiological studies of the “global” function of groups of muscles.” In terms of test-retest reliability and longitudinal muscle studies, SEMG was found to be superior to needle EMG. The CPG also states that SEMG provides an objective and quantifiable measure of muscular activity in areas of vertebral subluxation. Although the section discussing SEMG concludes with language indicating a degree of qualification, the CMG rates SEMG as “established.” An “established” rating means that SEMG is accepted as appropriate by the practicing chiropractic community for the given indication in the specified patient population. The rating of “established” was made with a Consensus Level of 1, which is the highest level of consensus available. In addition, the rating was supported by various categories of evidence used to analyze a given test, including expert opinion, clinical experience or effectiveness studies (Evidence E), refereed literature or published monographs, legal decisions and/or authority (Evidence L) and available controlled studies (Evidence C). The rating of “established” also requires one or more controlled trials. Therefore, read as a whole, the CMG demonstrates the medical value of SEMG as a clinical and diagnostic tool for evaluating paraspinal muscle activity, quantifying palpation findings, performing longitudinal studies, and detecting muscle spasm. Dr. Jenkins’ testimony regarding the lack of reliability of the CPG and attempt to disown the CPG as an authoritative statement by the Board of Chiropractors cannot be given weight since he was on neither the Florida Committee for Adoption of Guidelines nor the Board of Chiropractic when the CPG was accepted and endorsed. Additionally, during his tenure on the Board stretching back to 1997, the Board has not rescinded or amended the CPG. Finally, the evidence did not demonstrate that the CPG was superceded by the 1999 Universe of Florida Patients with Neck Pain or Injury Medical Practice Guidelines. These Universe Guidelines appear to relate only to medial doctors and not to Chiropractic Physicians. The Guidelines state they are not applicable to Chiropractic Physicians licensed under Chapter 460, Florida Statutes. The fact that the CPG describes SEMG as “[a]ccepted as appropriate by the practicing chiropractic community” provides a strong demonstration of the medical value of the test, and strong evidence of the high level of general acceptance of the test by the relevant provider community. Additionally, the American Medical Association Current Procedural Terminology (CPT) 2004 Manual is a proprietary system of the AMA for reporting medical services and procedures. CPT Codes are the uniform, established system for reporting medical services for reimbursement under government and private insurance programs. CPT coding is mandatory to describe the services a physician renders when submitting that service for payment to an automobile insurance carrier. In order to be assigned a five-digit CPT Code, the procedure must be “consistent with contemporary medical practice and be . . . performed by many practitioners in clinical practice in multiple locations. Code assignment is performed by a CPT Editorial Panel, consisting of 17 physician members, and a larger CPT Advisory Committee of medical and allied health professionals. Among the objectives of the CPT Advisory Committee is to “provide documentation to staff and the CPT Editorial Board regarding the medical appropriateness of various medical and surgical procedures. . . .” (emphasis supplied) Among the considerations for Code assignment are the requirements “that the service/procedure is a distinct service performed by many physicians/practitioners across the United States,” and “that the clinical efficacy of the service/procedure is well established and documented in peer review literature.” Dynamic SEMG has been assigned a five-digit CPT Code 96002. Similarly, The review and interpretation of dynamic SEMG has been assigned a five-digit CPT Code 96004. The fact that SEMG has been found to meet the requirements of the AMA for assignment of five-digit CPT Codes provides evidence of the medical value of the test, and strong evidence of the high level of general acceptance of the test by the relevant provider community. Finally, the rulemaking record for Rule 64B-3.004 contains information regarding SEMG. The literature submitted as part of the rulemaking record reveals, by a preponderance of competent, substantial evidence, that SEMG does not lack demonstrated medical value, and that it has a level of general acceptance by the relevant provider community. The primary documents submitted in the course of rulemaking included the 1993 Guidelines for Chiropractic Quality Assurance and Practice Parameters (Mercy Conference), the National Guideline Clearinghouse summary of the 1998 Council on Chiropractic Practice Guideline entitled Vertebral subluxation in chiropractic practice, a pair of AAEM Literature Reviews, entitled The Use of Surface EMG in the Diagnosis and Treatment of Nerve and Muscle Disorders and Dynamic Electromyography in Gait and Motion Analysis; the American Academy of Neurology study on Clinical utility of surface EMG; a report from Connie Coleman; two submissions from Dr. Jerome True, and a 2003 literature review, Surface EMG in Chronic Paraspinal Pain. Neither the Mercy Conference Guidelines nor the AAEM Surface EMG Literature Reviews contained any information or analysis more recent than 1993. Those documents did not reflect the current state of technology or understanding of SEMG, and could not form the sole bases for a rule based on SEMG’s demonstrated medical value and level of general acceptance in 2003. The National Guideline Clearinghouse summary of the 1998 Council on Chiropractic Practice Guidelines, and the American Academy of Neurology study on Clinical Utility of Surface EMG both provide support of the medical value for SEMG. As indicated, the 1998 Council on Chiropractic Practice Guidelines, which was subject to external peer review, and which even critics of SEMG recognize as being authoritative, determined that SEMG earned a rating of “established” “for recording changes in the electrical activity of muscles associated with vertebral subluxations” based on expert opinion, literature support, and controlled studies. The American Academy of Neurology study drew three conclusions, one of which was that Surface EMG “is an acceptable tool for kinesiologic (movement) analysis of movement disorders because it is a method for recording and quantifying clinically important muscle-related activity with the least interference on the clinical picture,” and confirmed its usefulness for several maladies, some of which result from automobile accidents. A report from Connie Coleman concluded that SEMG should not be in the rule, based on the American Academy of Neurology study, the AAEM Surface EMG Technology Literature Review, and a position paper authored by Aetna Insurance. Ms. Coleman’s report cannot be given any weight since she cited only the negative recommendations of the American Academy of Neurology study regarding SEMG, but omitted the third, positive recommendation from the study referenced above. Furthermore, as support for her recommendation to include spinal ultrasound in the rule, Ms. Coleman relied on the National Guidelines Clearinghouse document referenced above, which she stated was: a comprehensive database of evidence-based clinical practice guidelines and related documents produced by the Agency for Healthcare Research and Quality (AHRQ), U.S. Department of Health and Human Services, in partnership with the American Medical Association (AMA) and the American Association of Health Plans (AAHP). However, Ms. Coleman failed to note that the same National Guidelines Clearinghouse document gave SEMG a rating of established “for recording changes in the electrical activity of muscles associated with vertebral subluxations.” Of the two reports submitted by Dr. True, only one recommended that SEMG should have been on the list, with that recommendation based on a single journal article. Dr. True’s other submission mentioned SEMG, but made no specific recommendation regarding the test. However, Dr. True’s second submission did note that allegations of over utilization and abuse have “nothing to do with determining whether a test is medically valid.” Dr. True also relied on the Chiropractic Practice Guidelines and Parameters for the State of Florida, which recognize the medical validity of SEMG. Finally, David Marcarian, the developer and manufacturer of SEMG equipment, submitted several documents, including a literature review of journal articles ranging in dates from 1982 to 2002. The review discussed each of the journal articles, and concluded that “SEMG is a useful diagnostic tool in the evaluation of spine pain patients, and suggests that it be done routinely in cases where there is a need for disability and impairment determination.” The evidence did not demonstrate that Mr. Marcarian’s materials should be given less weight than older material containing dated information. The evidence submitted in this proceeding demonstrates a definite trend in both the understanding of the medical validity of SEMG and its acceptance by the chiropractic and medical community. Each of the 21 journal articles comprising Petitioner’s Exhibit 8, ranging in dates from 1988 to 2004, used SEMG as a tool to provide an objective measurement of muscle activity. Although many of the articles were focused on the muscular conditions leading to such conditions as low back pain, fibromyalgia, and whiplash disorders, rather than the clinical efficacy of SEMG itself, the fact that SEMG was so widely used as a measure of muscle activity is evidence of its medical value. Additionally, several of the articles focused on SEMG as a diagnostic tool in and of itself. Going back as far as 1988, researchers reported that “clear and consistent surface paraspinal EMG patterns can be discerned between differing groups of lower back pain patients and non-pain controls if the methodological limitations inherent in previous studies are corrected,” and concluded that “[t]he findings of the present study clearly point to the utility of differential diagnosis in lower back pain surface EMG studies,” and that “[r]esults strongly indicate that when careful attention is given to both diagnosis and position, surface EMG recordings can differentiate among the various types of lower back pain, as well as between those with and without lower back pain.” Electromyographic recordings of 5 types of low back pain subjects and non-pain controls in different positions, Arena, et al., "Pain", 37 (1989) pp. 63, 64. Through the early 1990s, researchers began noting the effect that technological advances were having on the medical efficacy of Surface EMG. Researchers during that period were recognizing that advances in surface electromyography (EMG) have prompted a renewed interest in examining the fatigue properties of back muscles. See Fatigue, recovery and low back pain in varsity rowers, Roy, et al., Medicine and Science in Sports and Exercise, vol. 22, no. 4, p. 463. As a result of those advances, those researchers concluded that “the EMG technique is able to correctly identify persons with LBP from two very different populations” [Id. at p. 467] and that “the results of this study have verified the usefulness of a surface EMG measurement technique to identify changes in back muscles that are characteristic of LBP in rowers . . . The technique may be useful to athletic trainers and other health professionals for evaluating the muscular component of LBP in their patients.” (Id. at 468). During that same period, researchers were beginning to conclude that, though not without limitations, "[e]lectromyo- graphic spectral analysis was shown again to be a highly sensitive and highly specific diagnostic test.” Comparison of Spinal Mobility and Isometric Trunk Extensor Forces with Electromyographic Spectral Analysis in Identifying Low Back Pain, Klein, et al., Physical Therapy, vol. 71, no. 6, p. 41 (1991). Other groups noted that contemporaneous research studies “have also shown the reliability of dynamic EMG measurements of paraspinal low back muscles,” and concluded that “[w]e believe that [EMG] is an invaluable aid in detecting and objectifying disturbed function in paraspinal muscles in back pain patients and in general disability. This agrees with recent research which indicates that kinetic EMG patterns (in contrast to static levels) may best show the complex biomechanical events in the lumbar region.” Electric Behavior of Low Back Muscles During Lumbar Pelvic Rhythm in Low Back Pain Patients and Healthy Controls, Sihvonen, et al., Arch. Phys. Med. Rehabil., vol. 72, pp. 1080, 1086 (1991). By the mid to late 1990s, the continuing research, though still recognizing that there were things left to learn, was becoming more conclusive as to the value of SEMG. In 1997, researchers funded by the Department of Veterans’ Affairs stated that “[w]e predict that in the future the concept of surface EMG- based imbalance or load sharing parameters may provide the clinician with important person-specific information already in the acute stage of the injury, to help prevent the development of a chronic disability. Surface EMG provides us with a powerful, noninvasive tool to investigate the status and function of muscles.” Development of new protocols and analysis procedures for the assessment of LBP by surface EMG techniques, Oddsson, et al., Journal of Rehabilitation Research and Development, vol. 34, no. 4, p. 425 (1997). During that same year, researchers in California studying muscular electrical signals, noted the technological advances that were serving to make SEMG more effective. In their study, they found that “[s]uccessful myoelectric recording with surface electrodes during dynamic exercise of the low back is relatively recent. This is largely due to the recent development of small high-competence preamplifiers located close to the muscle which reduces the electronic artifact during dynamic activity to allow analysis of the myoelectric signal.” Relationships Between Myoelectric Activity, Strength, and MRI of Lumbar Extensor Muscles in Back Pain Patients and Normal Subjects, Mooney, et al., Journal of Spinal Disorders, vol. 10, no. 4, p. 354 (1997). By the early 2000s, SEMG was becoming established as a reliable and valuable tool in the assessment and diagnosis of automobile related injury. In a peer-reviewed study regarding whiplash-associated disorders (WAD), the authors concluded that: Patients with whiplash associated disorder Grade II can be distinguished from healthy control subjects according to the presence of cervical muscle dysfunction, as assessed by surface electromyography of the upper trapezius muscles. Particulary the decreased ability to relax the trapezius muscles seems to be a promising feature to identify patients with whiplash associated disorder Grade II. Assessment of the muscle (dys)function by surface electromyography offers a refinement of the whiplash associated disorder classification and provides an indication to a suitable therapeutic approach. Cervical Muscle Dysfunction in the chronic Whiplash Associated Disorder Grade II (WAD II), Nederhand, et al., Spine, vol. 25 (15), p. 8 of 10 (2000). The authors noted that “the use of palpation to assess either muscle point tenderness or muscle spasm is questionable because manually tested musculoskeletal signs have shown poor interexaminer reliability, and very little is known about its diagnostic validity.” Id. The authors found that “SEMG as a measure of the inability to relax the upper trapezius muscles may be useful in diagnostic testing. In the literature this feature was shown to be related to cervical pain and muscle fatigue and therefore supports the clinical importance of this study’s findings.” Id. at p. 8 of 10. Also in 2000, researchers, while still recognizing the lack of absolute precision with all manner of electro-diagnostic testing (including X-rays, MRIs, CT scans, myelograms), stated that “surface electromyography (SEMG) is a non-invasive method of analysis of the degree of muscular activity and function.” Chronic Low Back Pain Assessment Using Surface Electromyography, Ambroz et al., JOEM, vol. 42, no. 6, p. 661 (2000). In recognition of the advances in technology, the authors noted that “[r]ecent technological advancement has overcome the previous limitations of data acquisition and processing.” Id. at 661. That study, while noting the need for accounting for physical conditions including body fat, and recognizing the advantages of further testing and study, made the following findings: More recent investigations have found a significant relationship between pain and SEMG-measured muscle activity in the upper and lower back and have suggested that SEMG can be a valid tool for objectively assessing LBP. Also, although Biederman questioned the reliability of SEMG reading in biofeedback research, two subsequent studies addressing the validity of this technique reported good reliability for the static and dynamic SEMG activities in the assessment of CLBP. By using a rigorous matching protocol that included BMI [body mass index], our study demonstrated a statistically significant difference between CLBP patients and pain free controls. Thus, the results of this study support the previous investigations suggesting that SEMG is a useful diagnostic tool in the assessment of CLBP. Furthermore, in this study the use of one of the latest and more technologically advanced semi devices available has contributed to a more reliable collection and processing of this data, giving more strength to this analysis. Finally, in 2004, the evidence regarding the medical value of SEMG demonstrates that it has achieved a full level of general acceptance. In a study released in June 2004, the authors concluded that “[s]urface electromyography has been shown to be useful in the evaluation of spine pain in much the same way that EKGs have become indispensable for chest pain evaluation. SEMG testing is easy to do, inexpensive, has no morbidity, and provides important information for the pain practitioner.” Objective Documentation of Spine Pain, Ambroz, et al., Practical Pain Management, May/June 2004, p. 36 Thus, it is clear that the evidence in this case demonstrates that there was no “lack” of demonstrated medical value to SEMG, but, that SEMG has a level of general acceptance for use in the treatment of patients by the relevant provider community. The real dispute in this case is how often SEMG is used in the relevant provider community. Therefore, the inclusion of SEMG in Florida Administrative Code Rule 64B-3.004 exceeds the Department’s grant of rulemaking authority, enlarges, modifies, or contravenes the specific provisions of Section 627.736(5)(b)6., Florida Statutes, and is arbitrary and capricious.
The Issue The issue presented for decision in this case is whether Respondent should be subjected to discipline for the violations of Chapter 458, Florida Statutes, alleged in the Administrative Complaint issued by Petitioner on April 24, 1997.
Findings Of Fact Based on the oral and documentary evidence adduced at the final hearing, and the entire record in this proceeding, the following findings of fact are made: Petitioner is the state agency charged with regulating the practice of medicine in the State of Florida, pursuant to Section 20.43, Florida Statutes, and Chapters 455 and 458, Florida Statutes. Pursuant to Section 20.43(3), Florida Statutes, Petitioner has contracted with the Agency for Health Care Administration to provide consumer complaint, investigative, and prosecutorial services required by the Division of Medical Quality Assurance, councils, or boards. At all times relevant to this proceeding, Respondent was a licensed physician in the State of Florida, having been issued license no. ME 00276678. At the time of Patient R.M.’s treatment, Respondent practiced orthopedic medicine. Respondent voluntarily ceased his orthopedic surgery practice in December 1994. He is currently employed as an assistant professor in the Department of Occupational Medicine at the University of South Florida College of Public Health. On July 28, 1993, Patient R.M., a 41-year-old female, presented to Respondent for an evaluation of right knee pain. Patient R.M. told Respondent that on November 1, 1992, she twisted her knee at home and heard a pop. Prior to this event, she had no knee problems. She told Respondent that she went to the emergency room at Brandon Hospital and was evaluated by the emergency room physician. The emergency room physician prescribed pain medication and placed her in a knee brace, gave her crutches, and advised her to see an orthopedic physician. Patient R.M. told Respondent that she had continued to experience swelling, occasional locking and giving-way of her knee over the intervening months. Respondent examined Patient R.M.'s right knee. He noted no obvious effusion or swelling, but did note tenderness over the medial joint line. Respondent noted that the right knee had a "full ROM" (range of motion), but his records did not quantify the patient's range of motion. Respondent noted a "markedly positive" McMurray's test. McMurray's test evaluates the stability of the knee meniscus. A positive McMurray's test is consistent with injury to meniscal structures. Respondent's records indicated that X-rays of the knee revealed no abnormalities. Respondent did not record the details of the X-rays, such as which planes were pictured or whether the X-rays were of the patella femoral joint or a standing lateral view of the knee. Respondent's records indicated to no examination or testing of the patella femoral joint. Dr. Harry Steinman, a board-certified orthopedic surgeon, opined that patella femoral problems can masquerade as meniscal problems in some situations, and that it is thus "mandatory" for the orthopedist to examine the patella femoral joint to rule it out as the locus of pathology. On the basis of his examination and Patient R.M.'s subjective complaints, Respondent's diagnostic impression was a tear of the medial meniscus, and his recommendation was an arthroscopic examination to evaluate and repair the tear. Respondent discussed his examination findings and treatment recommendation with Patient R.M. and explained the surgical procedure, including possible risks, complications, and alternatives. Patient R.M. subsequently signed a surgical consent form acknowledging that Respondent explained the necessity of the surgery, its advantages and disadvantages, its possible complications, and possible alternative modes of treatment. On August 6, 1993, Respondent performed an arthroscopic repair of the meniscus of Patient R.M.'s right knee. Respondent placed two sutures within the body of the meniscus, attaching it to the posterior medial capsule. Respondent made a second incision in the posterior medial aspect of the right knee. The posterior incision allowed Respondent to expose the capsule of the knee joint so that he could directly view the sutures as he passed them from the inside to the outside of the knee capsule, where he tied down the sutures and repaired the torn meniscus. This direct visualization was designed to ensure that any neurovascular structures were not impinged by the sutures. On August 11, 1993, Patient R.M. returned to Respondent for her first post-surgery examination. Respondent noted that the patient seemed to be doing well and her wounds were healing without difficulty. Respondent prescribed a Bledsoe brace, an articulated brace that allows for various ranges of motion, and advised Patient R.M. that she could begin partial weight-bearing with the use of crutches. Respondent advised Patient R.M. to return in three weeks for re-evaluation. Less than two weeks later, on August 23, 1993, Patient R.M. returned, complaining of numbness on the medial side of her right calf. On this visit, Patient R.M. was examined by Respondent's partner, Dr. Stuart Goldsmith, not Respondent. Dr. Goldsmith noted no effusion, redness, inflammation, or signs of infection. Dr. Goldsmith noted that Patient R.M. was wearing the Bledsoe brace "significantly tight," which could explain the numbness in the medial side of her calf. He advised the patient to loosen the straps on the brace, continue with range of motion exercises, and return to see Respondent in one week. Patient R.M. understood and agreed with Dr. Goldsmith's advice, and indicated she would return in one week. On September 1, 1993, Patient R.M. returned to Respondent for evaluation. She complained of decreased sensation along the medial side of her calf. Respondent noted that his evaluation revealed "what I determine to be almost normal sensation." Respondent also noted that he wondered whether Patient R.M. had a little irritation of the infrapatellar branch of the saphenous nerve at the site of the anterior medial stab wound. Respondent recommended that Patient R.M. begin range of motion exercises without the Bledsoe brace and commence physical therapy. He advised her to return in three to four weeks for re-evaluation. Patient R.M. returned two weeks later, on August 15, 1993, complaining that she heard a pop in the knee the night before. She told Respondent that she had not commenced physical therapy, but had been doing quite well prior to hearing the pop. Respondent noted that "sensation has apparently returned to normal." Respondent noted some tenderness along the medial aspect of the knee joint. He noted no effusion and a full range of motion, though again his records did not quantify the range of motion with numeric values. Respondent concluded that Patient R.M. had pulled apart some mild scar tissue, and again recommended commencement of physical therapy. He advised her to return in about one month for re-evaluation. On October 11, 1993, Patient R.M. returned to Respondent for evaluation. She continued to complain of decreased sensation along the anterior medial aspect of her right calf. She told Respondent that she had sensation, but that it was "different." Respondent noted that he wondered if the cause of this complaint might be that a portion of the infrapatellar branch of the saphenous nerve was nicked during surgery. Patient R.M. complained of pain extending from the inferior pole of her patella distally. Respondent noted that this pain was alleviated by bringing the patella medially, and that he had ordered a brace that he hoped would offer relief. Respondent advised Patient R.M. to continue therapy at home and to return in a couple of months. Patient R.M. never returned to Respondent's office. On November 16, 1993, Patient R.M. presented to Dr. John Okun, an orthopedic surgeon, for a second opinion. Dr. Okun took her history and performed an examination, including pinprick and light touch tests, and Tinel's sign, which indicates irritability of a nerve. Respondent testified that he had also performed these tests, but did not note them in his records. Dr. Okun suspected that a branch of the saphenous nerve had either been transected or caught in a suture during Respondent's operation, and believed that Patient R.M. would be best served by an exploration of the posterior aspect of the knee to see if anything could be done to restore nerve function. Dr. Okun noted that he discussed the situation at length with Patient R.M., advised her of the options, and received her assurance that she would consider the options and call him with any problems or changes. On December 3, 1993, Dr. Okun performed a surgical exploration of the nerve. He identified a loop of suture wrapped around the saphenous nerve. He removed the suture and freed the tissues surrounding the nerve. Dr. Okun followed Patient R.M.'s progress until March 1995. She generally reported improvement, but continued to complain of paresthesia and showed positive Tinel's signs in her lower leg. On March 8, 1994, Dr. Okun noted persistent nerve symptoms, and further noted that this was not surprising considering the degree of nerve compression. On May 5, 1994, Dr. Okun noted probable permanent damage to the nerve, but advised waiting another six months to one year before concluding that she had reached maximum improvement. Dr. Okun testified that, during his course of treatment, he never identified a significant patella tracking problem with Patient R.M. Dr. Okun also testified that Patient R.M. had a definite medial meniscus tear, and that "it looks like it was repaired fine" by Respondent's arthroscopic procedure. Dr. Steinman agreed at the hearing that there was a tear of the medial meniscus, and noted that Patient R.M. no longer complained of swelling, giving-way, or locking after the arthroscopic procedure. The evidence at hearing established that the surgical procedure performed by Respondent was within the standard of care. Respondent repaired a tear of the medial meniscus. The experts agreed that impingement of the saphenous nerve by a suture is a known and relatively common complication of the procedure performed by Respondent, despite the precaution of making an incision in the posterior aspect of the knee to visualize the posterior capsule. The experts further agreed that such impingement of the nerve during this procedure does not, of itself, establish that Respondent failed to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. Petitioner's allegations thus relate to Respondent's actions prior to and after the surgical procedure itself. The Complaint alleges that, prior to surgery, Respondent failed to perform an appropriate initial examination, failed to appropriately diagnose Patient R.M.'s condition, and failed to attempt conservative therapy prior to performing surgery. Dr. Steinman testified that Respondent should have examined the patella femoral joint in order to rule that out as a cause of the patient's symptoms. While conceding that Patient R.M.'s symptoms were all consistent with meniscal pathology, and that Respondent arrived at the correct diagnosis, Dr. Steinman opined that the patient was entitled to a full examination irrespective of the final outcome, and that the standard of care required an examination of the patella femoral joint. Dr. Steinman's testimony is credited on this point. However, the impact of his critique is lessened by that fact that Respondent's diagnosis was correct, the fact that Dr. Richard Goldberger examined the records and concluded that the patient was not suffering from a patella femoral joint problem, and the fact that Dr. Okun, who actually treated Patient R.M. for more than a year, also found no reason to believe that Patient R.M. had a patella tracking problem. Dr. Goldberger further observed that Patient R.M.'s only complaint regarding patellar pain was made after the surgery, not before. Under the circumstances, the worst that can be said of Respondent is that he went directly to the true cause of Patient R.M.'s complaint without affirmatively ruling out another possible cause. The evidence established that Respondent discussed a conservative course of therapy with Patient R.M. The evidence also established that a conservative course of therapy would have accomplished no tangible improvement in the tear of the medial meniscus. Dr. Richard Goldberger testified that physical therapy was not indicated for this patient. Dr. Goldberger testified that the only reason he would recommend physical therapy in this situation would be for the peace of mind of the patient, to assure a reluctant candidate for surgery that all conservative avenues had been exhausted. Even Petitioner's expert, Dr. Steinman, agreed that he would have discussed arthroscopy with the patient after the first visit, given her stated history and examination results. Dr. Steinman testified that after the initial examination, he would not have been convinced the patient had a meniscal tear, and would have recommended other treatments to confirm the diagnosis. However, he also stated that if Respondent was firm in his diagnosis of a meniscal tear, then diagnostic arthroscopy is what orthopedic surgeons generally would recommend. Respondent noted that Patient R.M.'s right knee showed a normal range of motion, though he did not note numeric values for the range of motion. This was not a deviation from the standard of care because loss of range of motion was not related to Patient R.M.'s pathology. Under the circumstances, it was sufficient for Respondent to note that range of motion was observed and found to be normal. Respondent failed to describe the X-rays he examined in reaching his diagnosis. Again, this was not a deviation from the standard of care because the information to be found in an X-ray was unrelated to the soft tissue injury that Respondent diagnosed in Patient R.M. Under the circumstances, it was sufficient for Respondent to note that X-rays were taken, examined, and found to be normal. In summary, Petitioner failed to establish by clear and convincing evidence that Respondent failed to meet the standard of care as regards his pre-operative treatment of Patient R.M. As to post-operative care, Petitioner alleges that Respondent failed to perform testing on the saphenous nerve when Patient R.M. complained of medial side numbness in the lower right leg, and failed to refer Patient R.M. to a neurologist for evaluation of a possible saphenous nerve injury. As noted above, Respondent employed a surgical technique by which he made a posterior incision in the knee, exposed the knee capsule, passed the suture from the inside to the outside of the knee, tying the suture under direct visualiztion. Respondent contended that use of this technique allowed him reasonably to assume that no injury to the saphenous nerve had occurred due to a suture being tied directly on it. This assumption explains why Respondent's post-surgery notes record his suspicions of a problem with the infrapatellar branch of the saphenous nerve. Respondent's technique would not have allowed him to observe an injury to the infrapatellar branch, because that injury would have occurred during placement of the surgical port on the medial aspect of the knee. Dr. Steinman testified that Respondent's observations were inconsistent with Patient R.M.'s complaints. He stated that the infrapatellar branch comes off the medial kneecap and travels in a medial to lateral direction. If the infrapatellar branch was interrupted, the area of numbness or abnormal sensation would have been on the lateral aspect of the patella, whereas the patient's complaints were along the anterior or medial aspect of the calf and ankle, outside the autonomous area of this nerve. Dr. Steinman testified that Patient R.M.'s complaints could lead only to the conclusion that the sartorial branch of the saphenous nerve had been jeopardized in some way. Dr. Steinman observed that Respondent appeared aware that there was a nerve problem, but that he was in error as to which nerve. Dr. Steinman testified that Respondent should have commenced some form of testing for a saphenous nerve problem no later than the October 11, 1993, visit, when she reiterated her complaints of decreased sensation along the medial aspect of her right calf and Respondent noted for the second time his suspicions regarding a saphenous nerve problem. Dr. Okun testified that if he had performed a meniscus repair and the patient presented these symptoms, he would probably have gone back into the knee and tried to snip the suture or at least explore the incision. However, he also testified that if he were comfortable that he had done everything properly and there was not a very high chance that he had trapped a nerve, he would wait for a period of three to six months to see if the problem would resolve on its own. Dr. Okun was unsure whether a definite standard of care could be stated for this situation. Dr. Okun also testified that whatever damage the nerve sustained was probably done at the time of the initial surgery, and would not get worse from having the constriction of the suture around it. He stated this was another reason why he might wait to perform a second procedure. Dr. Steinman strongly disagreed that the surgeon's degree of confidence in his work should play any role in his post-surgical treatment. The fact that the patient has complained of symptoms in a problematic area is evidence enough that there may be a problem, particularly where the complication is as common as this one, regardless of the surgeon's conviction that his suture missed the nerve. Dr. Goldberger testified that Respondent met the standard of care. Respondent was aware of the complaints of numbness and mentioned them and their severity in his notes. Dr. Goldberger stated that the saphenous is a sensory nerve and is not considered vital. Because the nerve has no motor function, the physician must rely on the subjective complaints of the patient regarding the symptoms. Some patients accept the symptoms and do not feel they are impaired by them. Dr. Goldberger testified that it was reasonable for Respondent to observe the patient's clinical course and pay attention to her complaints, without taking aggressive action. The weight of the evidence leads to a finding that Respondent might have been more aggressive in treating what he suspected was a saphenous nerve problem, and might have referred Patient R.M. to a neurologist to rule out a systemic problem, but that Respondent did not clearly deviate from the standard of care in choosing a more conservative course or failing to make a referral. Dr. Steinman severely criticized Respondent's post- surgical records in their failure to thoroughly document the sensory tests that Respondent testified he performed on Patient R.M. Respondent was not charged with failure to maintain adequate medical records. Thus, it is not necessary to address the merits of Dr. Steinman's critique of Respondent's medical records.
Recommendation Upon 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 April 24, 1997, Administrative Complaint against the Respondent, Steven A. Field, M.D. DONE AND ENTERED this 6th day of July, 2000, in Tallahassee, Leon County, Florida. LAWRENCE P. STEVENSON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 6th day of July, 2000. COPIES FURNISHED: John E. Terrel, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Christopher J. Schulte, Esquire Shear, Newman, Hahn, Rosenkranz, P.A. 201 East Kennedy Boulevard, Suite 1000 Post Office Box 2378 Tampa, Florida 33601-2378 Angela T. Hall, Agency Clerk Department of Health 4052 Bald Cypress Way Bin A02 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way Bin A02 Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
The Issue Whether Respondent violated Subsections 466.028(1)(m) and 466.028(1)(x), Florida Statutes (2001), and, if so, what discipline should be imposed.
Findings Of Fact The Department is charged with regulating the practice of dentistry pursuant to Section 20.43 and Chapters 456, 466, and 120, Florida Statutes (2003). At all material times to this proceeding, Dr. Nguyen was a licensed dentist in the State of Florida, having been issued license number DN0014768. On April 17, 2002, Patient J.N. presented to Dr. Nguyen complaining with pain from a broken tooth. She brought a full set of x-rays taken by another dentist approximately a year before her visit to Dr. Nguyen. J.N. filled out a form entitled "Health Questions." J.N. indicated on the form that her teeth were sensitive to cold. He examined J.N.'s teeth and saw that tooth 30 was fractured to the gum line. J.N. complained that the broken area of the tooth was sharp and was rubbing against her tongue causing irritation. His examination further revealed that she had some slight gum disease in the upper right side. J.N. was not experiencing a throbbing pain from tooth 30, and tooth 31 was not giving her any discomfort. Her discomfort was due to the inflammation of her gums and her tongue. Dr. Nguyen did a percussion test, i.e. tapping on the tooth, and probed in her mouth, measuring the tooth. Dr. Nguyen did not do any vitality testing and did not perform any periodontal charting of the teeth. J.N. did not want Dr. Nguyen to take any additional x-rays since she had brought a full set of x-rays with her. Dr. Nguyen felt that the set of x-rays that J.N. provided was sufficient for him to be able to treat J.N. for her fractured tooth. The x-rays did not show the fracture, but fractures may not necessarily show up on an x-ray. Dr. Nguyen told J.N. that she may or may not need a root canal. Dr. Nguyen discussed treatment options with J.N., and she decided to have a three-quarter crown on one tooth and an overlay on the other tooth. He removed all of the fracture of tooth 30 and made impressions for the three-quarter crown and inlay, which were sent to the laboratory for the fabrication of the crown and inlay. She left the office with temporary teeth on teeth 30 and 31. Dr. Nguyen made the following progress note concerning his treatment of J.N. on April 17, 2002: pt came in w/ fmx from another DDS. Dr. Richardt in Bonita. Both 30 & 31 have very large old fractured decay amalgam. Both lingual cusps #30 fractured to gingival line. Complaint of "uncomfortable." #30 prep for crown / 3/4 crown. #31 prep for MOB onlay. Composite provisional. A few days later, J.N. called Dr. Nguyen's office complaining of a lot of pain. J.N. was given a prescription for penicillin and Tylenol No. 3. On April 26, 2002, J.N. returned to Dr. Nguyen's office complaining of pain. She had taken the prescribed pain medication prior to her visit so that it was difficult for Dr. Nguyen to assess the pain. Dr. Nguyen made an adjustment to her bite and told her that if the pain continued that he would refer her to an endodontist. Dr. Nguyen asked J.N. to stop taking the pain medication and return to his office after 5 p.m. that day so that he could accurately assess her pain without having the pain medication masking the pain. She did not return to his office. On May 1, 2002, J.N. went to see another dentist, who referred J.N. to Juan Pablo Rodriguez, D.D.S. (Dr. Rodriquez), who specializes in root canals. J.N. complained to Dr. Rodriguez that she was having pain in tooth 30 and it was waking her up at night. Tooth 31 did not respond to cold. Dr. Rodriguez diagnosed J.N. with irreversible pulpitis for tooth 30, which means that the nerve of the tooth had inflammation, and that the nerve would not get better, but would die. He determined that tooth 31 was non- vital or necrotic. On May 8, 2002, J.N. called Dr. Nguyen's office and stated that she wanted to have her tooth extracted rather than have to pay for a root canal. She indicated she wanted her money back. The next day, J.N. came to Dr. Nguyen's office demanding her money back and wanting her x-rays. Dr. Nguyen kept the original x-rays and provided J.N. a copy of the x-rays which she had furnished him on her initial visit. J.N. had paid Dr. Nguyen a portion of his fees by credit card, and a portion of his fees had been paid by J.N.'s dental insurance plan. Dr. Nguyen refunded all fees paid to him. Melvin A. Platt, D.D.S., testified as an expert witness for the Department. It is Dr. Platt's opinion that Dr. Nguyen, in relation to his treatment of J.N., did not practice dentistry within the minimum standards of performance in diagnosis and treatment when measured against generally prevailing peer performance. His opinion is based on Dr. Nguyen's failure to determine the need for a root canal prior to preparing the teeth for restoration. According to Dr. Platt, Dr. Nguyen should haven taken an x-ray of teeth 30 and 31, performed vitality testing, and done periodontal charting. Dr. Platt was also of the opinion that the dental records maintained by Dr. Nguyen regarding his care of J.N. failed to justify his course of treatment. According to Dr. Platt there was nothing in the progress notes to justify going ahead with the restorations without any prior testing of any kind. Dr. Nguyen's license has previously been disciplined by the Department for failing to include in an advertisement the statement required by Section 456.062, Florida Statutes (1999). Department of Health v. Luyen Nguyen, D.D.S., Case No. 2000- 01848 (Dept. of Health 2002).
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding that Luyen Nguyen, D.D.S., did not violate Subsection 466.028(1)(m), Florida Statutes, but did violate Subsection 466.028(1)(x), Florida Statutes; imposing a $1,000 administrative fine; and issuing a reprimand. DONE AND ENTERED this 4th day of March, 2004, in Tallahassee, Leon County, Florida. S SUSAN B. KIRKLAND Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 4th day of March, 2004.
The Issue At issue in this proceeding is whether Katelyn Foley, a minor, suffered an injury for which compensation should be awarded under the Florida Birth-Related Neurological Injury Compensation Plan.
Findings Of Fact Preliminary matters Terry Gerstein-Foley (Mrs. Foley) and Myles Foley are the parents and natural guardians of Katelyn Foley (Katelyn), a minor. Katelyn was born a live infant on April 28, 1995, at Memorial Hospital, a hospital located in Hollywood, Florida, and her birth weight exceeded 2500 grams. The physician providing obstetrical services during the birth of Katelyn was Eric N. Freling, M.D., who was, at all times material hereto, a "participating physician" in the Florida Birth-Related Neurological Injury Compensation Plan (the Plan), as defined by Section 766.302(7), Florida Statutes. Given the parties' agreement to the foregoing facts, what remains to resolve is whether the proof persuasively demonstrates that the anomalies with which Katelyn presents were occasioned by an "injury to the brain . . . caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate post-delivery period" and, if so, whether such injury rendered her "permanently and substantially, mentally and physically impaired." Katelyn's birth At or about 5:15 p.m., April 27, 1995, Mrs. Foley presented to Memorial Hospital in labor. At the time, Mrs. Foley was post-term at 41 plus weeks, but her pregnancy was otherwise unremarkable. The obstetrical assessment on presentation reflects that contractions began at 12:30 p.m., April 27, 1995, and the membranes spontaneously ruptured at 3:30 p.m., with clear fluid noted. Vaginal examination revealed dilation at 2 to 3 centimeters, effacement at 50 percent, and the fetus at station -2. Fetal heart rate was recorded at 120 to 125 beats per minute. Mrs. Foley was admitted to the labor and delivery room at approximately 6:00 p.m., and an external fetal monitor was applied. Fetal heart rate was recorded as 120 to 130 beats per minute. Mrs. Foley labored through the evening, and at 10:45 p.m. vaginal examination revealed dilation at 4 centimeters, effacement at 70 percent, and the fetus at station -1. Fetal heart rate continued in the 120 to 130 or 130 to 140 beat per minute range, with accelerations. At 11:40 p.m., the monitor was disconnected and Mrs. Foley went to the bathroom. At 11:46 p.m., Mrs. Foley called the nurse, and heavy vaginal bleeding was observed. In response, Mrs. Foley was immediately put in bed on her right side and oxygen was administered. Internal fetal electrode was applied, and fetal heart rate was recorded at 116 to 126 beats per minute. Vaginal examination revealed dilation at 6 centimeters, effacement at 90 percent, and the fetus at station -1. Labor continued without any significant observations noted until 12:15 a.m., April 28, 1995, when variable decelerations were noted and decreased variability. Monitoring revealed the fetal heart rate at 118 to 128 beats per minute. Mrs. Foley was repositioned and administered oxygen. At 12:30 a.m., the fetal heart rate was noted at 120 to 130 beats per minute, with occasional late decelerations and decreased variability; however, the fetal heart rate was noted as difficult to track, as the internal electrode was not working well. Mrs. Foley was repositioned to her side and administered oxygen. At or about 12:57 a.m., vaginal examination revealed dilation complete, effacement complete, and the fetus at station +2 to +3. Consequently, although audibly the fetal heart rate was reassuring, Dr. Freling elected to promptly effect delivery because of the continuing difficulty in recording the fetal heart and uncertainty about its pattern. At 1:10 a.m., April 28, 1995, a vaginal delivery, with vacuum assistance, was effected. Placenta was delivered at 1:22 a.m., with no abruption noted. Consequently, Dr. Freling concluded the vaginal bleeding was heavy secondary to fast cervical dilation. Cord pH at delivery was 7.15, and Katelyn presented with an Apgar score of 4 at one minute, with heart rate being graded at 2, respiratory effort and reflex being graded at 1 each, and tone and color being graded at 0 each. At five minutes, Katelyn's Apgar score totaled 7, with heart rate and reflex being graded at 2 each, and respiratory effort, tone, and color being graded at 1 each. By ten minutes grunting and retractions were apparent, and Katelyn was transported to the new baby intensive care unit for monitoring incident to respiratory distress. Katelyn developed hyperbilirubinemia and remained hospitalized until May 5, 1995, when she was discharged to her mother's care. The findings regarding Katelyn's condition on admission to the neonatal intensive care unit and her course of treatment are described in the discharge summary as follows: HISTORY AND PHYSICAL: . . . Infant had few abrasions on buttocks, blood noted on scalp from an electrode site, ? craniotabes1/cephalohematoma2, decreased perfusion, weak pulses, poor aeration with rales and tachypnea3, soft, thin cord, slightly decreased activity of right arm, bilateral hip clicks (Left dislocatable) noted on admission. The rest of the physical examination was essentially normal for gestational age. ADMITTING DIAGNOSES: Vacuum extraction Respiratory distress R/O acidosis Probable craniotabes HOSPITAL COURSE: Respiratory distress: Infant initially presented with decreased aeration, with rales, & tachypnea which quickly resolved without intervention. . . . Neuro: Infant initially presented with ? craniotabes & decreased activity of right arm. Also with asymmetric crying facies with decreased motion of left angle of mouth. Dr. Mollestan consulted on 4-28 with CT showing ? bending of skull bones, negative bleeding. No follow-up needed. * * * Ortho: Presented with bilateral hip clicks with the left hip dislocatable. Consult with Dr. Reich on 4-29 showed bilateral CDH treated with a pavlik harness. Infant to be followed-up 1 month after discharge. . . . * * * DISCHARGE: Discharge was on 5-5-95 with weight 2870 gms and head circumference 35 cm. Physical examination showed craniotabes, bilateral cephalohematomas, dry scalp probe site, holds neck to left side - improving, hips dislocatable - pavlik harness in place, icteric, otherwise was within normal limits. Feedings are Enfamil with Iron ad lib q 4h. Medications include Bacitracin to scalp probe site. Last Hct on 5-3 was 38.5%. Dr. Budowsky will be the Pediatrician following the infant after discharge.4 Other follow up appointments include outpatient PEIP, Ortho Dr. Reich on 5-8 also with ultrasound, Neuro Dr. Brown 1 month. DISCHARGE DIAGNOSES: 41 week newborn Transient tachypnea of the newborn Vacuum extraction Sepsis ruled out Congenital dysplasia5 of hips Hyperbilirubinemia Craniotabes Katelyn's subsequent development and medical care Consistent with the discharge summary, Katelyn was followed orthopedically by Dr. Reich for dysplasia of the hips, and progressed well with the harness. At seven weeks the harness was removed, and Dr. Reich observed that range of motion and ultrasound were normal. Katelyn was last seen by Dr. Reich on October 2, 1995, for a follow-up visit. At that time, Dr. Reich noted she had a normal exam of her hips, and she was essentially normal on x-ray. Also consistent with the discharge summary, Katelyn was examined by Dr. Stuart Brown, a pediatric neurologist, on June 9, 1995. That examination revealed: Physical examination revealed a lovely five-week old baby, who weighed 11 pounds. Her head circumference was 38 cm. I did not measure her length, which appeared appropriate for her weight. Facial features were normal. The fontanel was depressed and the sutures were normal. A small, 1 cm., linear, reddish area was noted in the right parietal region, without any evidence of edema, and with the underlying skull feeling normal to palpation. There was no evidence of hematoma. The neck was supple with a full range of movement. The child was noted to be in harness to alleviate a hip dislocation. The heart was normal to auscultation and the abdomen was soft without any organ enlargement. The spine was straight and the skin did not show any pigmentary abnormalities. The neurological assessment revealed full extraocular movements with equal and reactive pupils, and a normal right optic disc. The facial musculature was normal and the tongue was normal, and cry was lusty. Midline face and palate were normal. Muscle tone was normal in the extremities and the deep tendon reflexes were equal and active. Plantar responses were bilaterally flexor. Moro response was active and symmetrical, and tonic neck reflexes were fragmentary. Vestibular responses were normal. Suck was normal. Seizures and involuntary movements were not seen. IMPRESSION This child is neurologically normal, without showing any evidence, at this time, of any residual impairment from the birth trauma and linear skull fracture. She is not in need of any neurological follow-up, but I will be pleased to see her if the need arises. On August 30, 1995, on the referral of her pediatrician, Katelyn was seen by Dr. Michael Jofe, a board certified orthopedic surgeon, for a consultation. Dr. Jofe's observations and conclusions are set forth in his report of August 30, 1995, as follows: I saw your patient, Katelyn Foley, in my office on August 30, 1995. Katelyn is a 4- month old baby girl who you referred for evaluation of her neck. Katelyn was born with subluxed hips and was treated with a Pavlik harness. Through an early intervention program she has been receiving physical therapy and Mary Flanders, her physical therapist, noticed that her head wasn't right. She is sent today for evaluation. She was a difficult pregnancy and delivery and developed what sounds like a cephalhematoma. She was hospitalized in the Newborn Intensive Care Unit for eight days after birth. Otherwise, her family and past medical history is unremarkable. On exam she tends to hold her head with her left ear towards her left shoulder and her chin towards her right shoulder consistent with a left torticollis.6 I can correct her to neutral but not much beyond. The remaining surface exam of her spine is unremarkable. She has a full range of motion of her upper and lower extremities. She has a negative Ortolani, Barlow and Galeazzi's sign to her hips. The neurologic exam was normal including motor, sensation, and reflexes. There was no evidence of clonus and both toes are downgoing. Straight leg raising is negative bilaterally and the abdominal reflexes are normal. She has a thickening of the sternocleidomastoid of her neck but not severely so. I x-rayed Katelyn's neck today and the x-rays are basically unremarkable. Katelyn therefore has a history and physical exam consistent although not diagnostic of torticollis. In general, there is a pseudotumor caused by thickening of the sternocleidomastoid that occurs within the first few weeks to few months of life and then gradually resolves. However, the deformity remains. I don't feel a definite pseudotumor and therefore I am going to check an MRI to make sure there is no other underlying lesion. However, I suspect that this is torticollis and we will need to direct physical therapy towards that. Following further examination, Dr. Jofe concluded Katelyn's presentation was most consistent with mild torticollis, and instructed her parents on physical therapy and also recommended formal physical therapy. Dr. Jofe continued to monitor Katelyn's progress, as related to mild torticollis and, following Dr. Reich, as related to her hip development. Katelyn progressed well with therapy, and according to the last observations of Dr. Jofe in a report to Katelyn's pediatrician on May 22, 1996, her condition was as follows: . . . she is continuing to do well. Her neck is essentially straight. When she is tired her parents relate that she tends to tilt a little to the left but nothing severe. She has full range of motion of her head and neck and moves it completely normal in the office. Her hip exam is normal also . . . [and] [h]er hip x-rays show her hips to be developing well. . . . In addition to the foregoing consultations, Katelyn was also referred to Children's Diagnostic and Treatment Center of South Florida (Children's Diagnostic Center) for developmental evaluation. The first evaluation, July 26, 1995, revealed appropriate mental and psychomotor development for her age; however, extreme weakness of the neck with significant head lag was reported. Katelyn was also noted to have weak upper and lower extremities, and it was felt she would benefit from physical therapy. Katelyn's next developmental screening at Children's Diagnostic Center was October 30, 1995. That evaluation concluded: Katelyn's performance on the Bayley Scales of Infant Development II was within normal limits on the Mental Scale and mildly delayed on the Psychomotor Scale. At this time, it appears she has some difficulties in the area of gross motor functioning. According to mother, an orthopedic physician and a physical therapist are currently providing services to address these concerns.7 Mother was encouraged to have Katelyn practice picking up small items at home to enhance her fine motor skills. According to the proof of record, the last developmental screening at Children's Diagnostic Center occurred on April 1, 1996. The results of that screening were similar to the previous screening and revealed: Katelyn's performance on The Bayley Scales of Infant Development II was within normal limits on the Mental Scale and mildly delayed on the Motor Scale. She currently sees an orthopedist and receives physical therapy once a week. Katelyn's gross motor difficulties were shared with the clinic staff to address further. Finally, in May 1996, having diagnosed Katelyn with developmental delay, her pediatrician referred her to Dr. Robert Cullen, a pediatric neurologist, for consultation. That consultation apparently occurred in July 19968; however, if it was ever reduced to writing, its results are not of record. But, Katelyn's follow-up consultations with Dr. Cullen on March 26, 1997, and September 8, 1997, are of record. (Petitioner's Exhibits 3 and 4). Dr. Cullen's report for his neurologic consultation of March 26, 1997, contained the following pertinent observations: This 23-month-old young lady was last seen by me back in July. She does indeed have a picture of an atonic diplegia.9 She also had a hypoplasia10 or absence of the left depressor anguli oris muscle. Her general health since her last visit has been good. . . . She started to walk independently at 18- months. She now has a 12 word vocabulary. She tries to dress herself. Her motor skills are still behind and tone is behind . . . She presents now for a neurological evaluation. PHYSICAL EXAMINATION now showed her to be a fairly adequately nourished and developed 23- month-old young lady who was in no acute distress. . . . She still had loose heel cords and some loose hip abduction . . . NEUROLOGICALLY, she was alert. She used an occasional word. She cried loud and lustily to noxious stimuli, but could be quieted quite readily when held by her father. Cranial nerves II-XII did show the pupils to be equal and regular and they did react to light. The extraocular eye movements were full. The right disc was flat. I did not get a good look at the left disc. She had full visual fields. There was no facial weakness. She still did not depress the left corner of the mouth fully, but this had improved from in the past. She had adequate auditory responses, a good gag, good palatal and pharyngeal movements and the tongue did remain midline. MOTOR EXAMINATION showed adequate muscle bulk. Tone was still a bit decreased. Grasp and traction were fairly good. She was able to walk and run. I did not see any asymetry of her arm movement when running. There was still a minimal degree of genu recurvatum.11 SENSORY EXAMINATION was intact to pin. . . . The plantars were indeed flexor. CEREBELLAR EXAMINATION showed no real dysfunction with finger-to-nose type movements. IN SUMMATION, Katelyn is a 23 month-old-young lady with a picture of an atonic diplegia and a development language delay. She does indeed have a hypoplasia or absence of the left depressor anguli oris muscle. I think she is improving in terms of her motor skills. Her language still remains behind. She has some minimal genu recurvatum. I do not think we need to be in a formal program of therapy at this time. I would like to see her here in December to see how she is doing. . . . Katelyn's next visit to Dr. Cullen was on September 8, 1997. The report of that consultation contained the following pertinent observations: This 28 1/2-month-old young lady was last seen by me back in March. She does indeed have a picture of an atonic diplegia. She also had a developmental language delay. She had a hypoplasia or absence of the left depressor anguli oris muscle. Her general health since her last visit has been good. . . . Her mother said she started three-word phrases at about 27-months. She does not really dress herself yet. She goes to a gym class, but is not in school. She is not toilet-trained. . . . Her muscles are a little bit stronger. Her mother feels that she is a little less agile than other children in the gym class. Her behavior is good. She is no longer in therapy. There is litigation and they are represented by Mr. Schlessinger's firm. She does present now for a neurological re-evaluation. PHYSICAL EXAMINATION now showed her to be a fairly adequately nourished 28 1/2-month-old young lady who was in no acute distress. . . . There were no heel cord contractures. She had somewhat loose ankles and loose knees and adequate hip abduction. NEUROLOGICALLY, she was alert and apprehensive initially. She pointed to a number of pictures in a small coloring book and could identify most of them. I could not really get her to count at this point. When she was upset, she was indeed quite stubborn. Cranial nerves II-XII did show the pupils to be equal and regular and they did react to light. The extraocular eye movements were full. The left disc was flat. I did not get a good look at the right disc. She had full visual fields. There was no facial weakness or asymmetry. She had adequate auditory responses, a good gag, good palatal and pharyngeal movements and the tongue did remain midline. MOTOR EXAMINATION showed adequate muscle bulk. Tone was still a bit decreased. When walking, her gait was still a little bit unsteady and she had some tremulousness of her upper extremities. SENSORY EXAMINATION was intact to pin. . . . The plantars were indeed flexor. CEREBELLAR EXAMINATION showed no real dysfunction with hand movements. It should be mentioned that we did still have a failure to fully depress the left side of the mouth. IN SUMMATION, Katelyn is a 28 1/2-month-old young lady. She has a picture of an atonic diplegia which is clearly improving. She also has hypoplasia or absence of the left depressor anguli oris muscle. She does have a developmental language delay. I have suggested to her mother now some things that she could do to improve language at home. I do think she should be in a Mommy and Me program at least 1/2 a day a week which would improve language and improve behavior. We will try and see her in a 6-month time period and see how she is doing. The cause and significance of Katelyn's condition At hearing, neither Petitioners nor Respondent elected to call or present testimony from any of Katelyn's health care providers, including the physician who provided obstetrical services at birth, Katelyn's pediatricians, Katelyn's pediatric neurologists, Katelyn's orthopedic surgeons, or any of the other myriad of health care providers associated with her care, diagnosis and treatment. The parties did, however, introduce into evidence medical records dealing with Katelyn's birth and subsequent development and, presumably, those records adequately address the circumstances surrounding her birth and development, as well as the findings and opinions of her health care providers. Those circumstances, findings, and opinions are addressed supra. Notably, among the observations and opinions of those who treated Katelyn, there is no suggestion or finding that she suffered a debilitating neurologic injury at birth, whether by oxygen deprivation or otherwise. To the contrary, when called upon to address Katelyn's neurologic condition, it was noted as normal. Moreover, Katelyn's more pronounced anomalies are congenital or developmental in origin. Finally, there is no suggestion or finding by Katelyn's treating physician's that she is "permanently and substantially mentally and physically impaired." Rather, where observations are made, her mental condition is noted as age appropriate, and her physical condition as mildly delayed and improving. Apart from the circumstances, observations, and opinions reflected in the medical records, the parties offered the testimony of three physicians to address whether Katelyn "sustained an injury to the brain caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate post-delivery period," which rendered her "permanently and substantially mentally and physically impaired." Section 766.302(2), Florida Statutes. The physicians selected by Petitioners were Doctors Paul Gatewood and Houchang Modanlou, and the physician selected by Respondent was Dr. Lance Wyble. None of these physicians could be characterized as treating physicians, and none had examined Katelyn.12 Dr. Gatewood is a board certified obstetrician, and Dr. Modanlou is a board certified neonatologist. Each of these physicians, based on their review of the medical records, opined, without elaboration or explanation, that Katelyn suffered an injury to the brain caused by oxygen deprivation and trauma during the course of labor, delivery, or resuscitation in the immediate post-delivery period, which rendered her permanently and substantially mentally and physically impaired. Dr. Wyble, like Dr. Modanlou, is a board certified neonatologist. It was Dr. Wyble's opinion, based on his review of the medical records, that Katelyn's presentation at birth was not consistent with a brain injury, whether caused by oxygen deprivation or mechanical injury, suffered during the course of labor, delivery, or resuscitation in the immediate post-delivery period, and therefore her current condition must be attributable to some other cause or etiology. In so concluding, Dr. Wyble, contrasted with Doctors Gatewood and Modanlou, offered an explanation, based on the medical evidence, as to why he had reached such a conclusion. That explanation was credible, and was not addressed or rebutted by Petitioners. The explanation offered by Dr. Wyble was that, based on Katelyn's clinical course, there was no evidence of organic brain damage within the 24-hour period preceding delivery and the 5 or 6 day period thereafter. Such conclusion was predicated on numerous inconsistencies between Katelyn's presentation and the clinical findings one would expect had she suffered an injury to the brain, whether by oxygen deprivation or trauma. First, had Katelyn suffered such an injury during that period, one would reasonably expect evidence of damage to multiple organ systems, including the kidneys, heart, and lungs. Here, no such damage was evident. Additionally, evidence in the blood work mitigates against a finding of brain injury during this period. In this regard, it is observed that Katelyn's lymphocyte count at one hour of life was 10,442, but by the eleventh hour of life it was 7,667. Had an injury occurred during labor or delivery, the lymphocyte count should have remained above 10,000 beyond the eleventh hour of life. Additionally, the blood work related to renal function showed the serum sodium to be normal. Had an injury been suffered, the injury would have affected kidney function and the serum sodium would be low. Moreover, mitigating against injury to the kidney, the infant's urine output was excellent. Finally, Katelyn's clinical presentation following birth did not evidence any neurologic changes suggestive of injury to the nervous system. Specifically, had she suffered a neurologic injury at birth, or even shortly before birth, one would expect her neurologic status to be diminished, with poor responsiveness, for about 12 hours. Here, the infant was neurologically active and normal by one to two hours after birth. Moreover, had she suffered such a neurologic injury, beginning around 12 hours of birth and extending up to 24 hours, one would expect the infant to become hyperresponsive, with irritability, and she would most likely exhibit seizure activity. Here, Katelyn was neurologically normal during such periods. Given the proof, it cannot be concluded that, more likely than not, Katelyn's anomalies are associated with a brain injury caused by oxygen deprivation or mechanical injury occurring during labor, delivery, or resuscitation in the immediate post-delivery period, as opposed to some other etiology.13 Indeed, the more credible and persuasive proof is to the contrary. Similarly, the proof is not compelling that Katelyn is permanently and substantially mentally and physically impaired. In so concluding, the contrary opinions of Doctors Gatewood and Modanlou, have not been overlooked. However, the records on which they based their opinions do not reasonably support their conclusions. Consequently, the opinions of Doctors Gatewood and Modanlou are rejected as lacking in credibility and persuasiveness.
The Issue Whether petitioner should take disciplinary action against respondent for the reasons alleged in the administrative complaints?
Findings Of Fact Respondent Patrick J. McCarthy has practiced obstetrics and gynecology in Tallahassee, Florida, since 1976. He "qualified as a doctor in 1958" (T.215) at the University of Wales, did residencies in Canada, including three years in obstetrics and gynecology at McGill University, and practiced in New Hampshire, before coming to Florida, where he is duly licensed to practice. Board certified here and abroad, Dr. McCarthy now delivers 200 to 250 babies a year. Over his career, he estimates, he has delivered 7,000 to 8,000 infants. T.225. In 1981, he "recertified in obstetrics and gynecology in the American boards." T.236. C.H. On November 1, 1984, Dr. McCarthy admitted C.H., a 23-year old mother of one whom he had been seeing in his office during her second pregnancy. Labor had begun shortly after midnight, about five hours before C.H. arrived at the hospital. At quarter past six that morning, when C.H.'s cervix had dilated to a diameter of seven or eight centimeters, respondent did not accede to C.H.'s request for epidural anesthesia. At 6:36 a.m., however, C.H. received Demerol and Phenergen, medicines Dr. McCarthy ordered, and later got local anesthesia, a "pudendal block" designed to numb the area in which an episiotomy was eventually performed. Four minutes later C.H. was taken to the delivery room. C.H.'s cervix was fully dilated by ten of seven. At 6:58 a.m., Dr. McCarthy applied a vacuum extractor, but he did not succeed in delivering the baby's head until 7:20, after he had resorted to low forceps. His head out, the baby's shoulder lodged behind his mother's pubic symphysis. All ten pounds and seven ounces were stuck. Once the head is delivered, the rest of the baby should be delivered within five or six minutes to avoid the risk of damaging or losing the child. The umbilical cord's function can be compromised if it is pinched between the baby and strictures in the birth canal. At this point, Dr. McCarthy performed what he called a Wood's maneuver. Wood's maneuver, also known as the corkscrew maneuver, was unquestionably acceptable practice at the time, if properly performed "by applying pressure on the back of the [baby's] shoulders." T.134. Currently the preferred initial response to shoulder dystocia is to bend and raise (if she is supine) the mother's legs to reposition the pubes. Named after a Dr. McRoberts, this approach was used in Tampa in 1984, but was apparently unknown to Dr. McCarthy at that time. In describing C.H.'s baby's birth, which took place at 7:23 on the morning of November 1, Dr. McCarthy wrote in the chart: "Marked shoulder dystocia -- shoulders rotated through 180o." Joint Exhibit No. 1. Later, asked about these events while under oath, he answered: I rotated the head and shoulders. Q. How did you do that? A. Thats called -- it's a thing called Wood's maneuver, where you are using -- you rotate the head so that the shoulders will follow it. The posterior shoulder then comes under the symphysis of the pubic. It's lower than the anterior. When you have that, then you have the baby up. Q. And in that process do you place a downward pull on the baby's head? A. No, you rotate. . . . Q. From the process of this delivery was there any injury to this baby? A. Yes, the baby had a brachial plexus palsy. Q. How did the brachial plexus palsy occur? A. Presumably when I turned the head, it stretched the nerves in the brachial plexus at the base of the neck. Q. That would have been when you turned the head in the last maneuver that you attempted or would that have been in the first maneuver when you are pulling down on the head? A. Usually when you turn the head. Q. In this case do you know when the injury occurred? A. Usually it happens when you turn the head. It's a twisting motion, because this is the greatest stretch motion. Petitioner's Exhibit No. 2, pp. 51-3. Dr. McCarthy's testimony at hearing that he did not turn the baby's head (except by turning the baby's shoulders) in performing what he called a Wood's maneuver has not been credited. Whether or not (as Dr. McCarthy assumed) the twisting caused the brachial plexus palsy with which the child is afflicted, rotating the baby's head "so that the shoulders w[ould] follow it" was a departure from minimally acceptable practice. On this point, every expert who testified was in agreement. The records do not indicate whether C.H. was catheterized before her delivery. Presumably she was not, but petitioner did not allege and the evidence did not show that she needed a urinary catheter. Petitioner did not establish any dereliction on respondent's part in his keeping of records on C.H. or her delivery, aside from the elliptic description he gave of his rotary manipulation. M.B. Before the day she was delivered, M.B. had been under the care of M. J. Moreton, M.D., who was apparently unavailable at twenty past eleven o'clock on the morning of October 9, 1984, when M.B., then the 28-year-old mother of one child, arrived at Tallahassee Memorial Regional Medical Center. Irregular contractions had begun earlier that morning, and persisted until that afternoon, when Dr. McCarthy, who had undertaken M.B.'s care, directed that she be given a drug "to get her into good labor." Joint Exhibit No. 2. The drug to induce regular contractions was administered at four o'clock. She received epidural anesthesia at intervals. Vomiting, begun at ten o'clock that night, a half hour before her cervix was fully dilated, interfered with M.B.'s ability to push. Sporadically, the fetal monitor indicated pulse rates as low as 70. Dr. McCarthy used a vacuum extractor to deliver the baby's head, and encountered shoulder dystocia. At hearing, Dr. McCarthy recounted his use of a procedure called Hibbald's maneuver, one of a number of accepted techniques for dealing with shoulder dystocia: . . . I told the nurse to apply fundal and suprapubic pressure and I grasp[ed] the head and pulled it down approximately a forty-five degree angle . . . I was applying moderate traction to the head and the baby delivered. T.258-9. Two or three minutes after the delivery of the head, M.B.'s baby was born at 10:47 p.m. on October 9, 1984. "The only unusual thing about the baby, apart from the brachial plexus palsy, was that there was a cord around the shoulder," (T.259) presumably the cause of the intermittently depressed fetal pulse rate. Dr. McCarthy acknowledged that he "could have used many maneuvers," (T.260) other than Hibbald's. He ascribed his exclusive use of Hibbald's maneuver to the shortness of the time it took to deliver the baby. At some point, reliance on a technique that is not succeeding, to the exclusion of others that might dislodge a baby without causing brachial plexus palsy, a known complication of shoulder dystocia, falls below minimally acceptable standards of practice. During the two- or three-minute interval between delivery of the baby's head and extrication of his shoulder, Dr. McCarthy "checked the baby to see if there was a cord around the neck," (T.261) and suctioned fluid from the baby's nostrils. The evidence did not clearly show how long he applied traction before the baby was delivered. An expert testifying for petitioner said that a patient with epidural anesthesia "in general is unable to void . . . and . . . the bladder can enlarge . . . and can interfere . . . [so that] it's good obstetrics, before performing a forceps or vacuum delivery to catheterize. . . ." T.55. But there was no testimony that failure to catheterize fell below minimally acceptable standards, nor any testimony to establish M.B.'s particular circumstances. The evidence established no deficiencies in respondent's recordkeeping with regard to M.B. or her delivery.
Recommendation Although later adopted and, therefore, not determinative, see Willner v. Department of Professional Regulation, 563 So.2d 805 (Fla. 1st DCA 1990), Rule 21M-20.001(2)(t), Florida Administrative Code, specifies penalties for violating Section 458.331(1)(t), Florida Statutes (1991), ranging from two years' probation to license revocation, together with a fine of $250 to $5000, depending on aggravating and mitigating circumstances set out in Rule 21M- 20.001(3), Florida Administrative Code. Upon consideration of the foregoing findings and conclusions, and the length of time that has elapsed since the birth of C.H.'s baby, it is RECOMMENDED: That the Board of Medicine place respondent on probation for a period of five (5) years, on condition that he attend a minimum of thirty (30) hours per year of category I continuing medical education courses, including, within the first ninety (90) days of probation, ten (10) hours of courses on how to manage shoulder dystocia; and on further condition that he perform 250 hours of community service under the auspices of the county health department, if needed, during each year he is on probation; provided, however, that the question of penalty be reopened, in the event respondent fails to abide by the conditions of probation or to make reports to the Board on or before the tenth day of each month, reflecting compliance with the conditions of probation. DONE and ENTERED this 4th day of February, 1993, at Tallahassee, Florida. ROBERT T. BENTON, II, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 4th day of February, 1993. APPENDIX Petitioner's proposed findings of fact Nos. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, both 17s, the first 18 and 19 regarding C.H. and Nos. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 13, 14, 15, and 16 regarding M.B. have been adopted, in substance, insofar as material. With respect to petitioner's proposed findings of fact Nos. 16 and the second 18 regarding C.H., respondent unquestionably exposed the baby to the risk of serious injury, and more than likely caused the brachial plexus palsy. With respect to petitioner's proposed findings of fact Nos. 12, 18, 19, 20, 25 and 27 regarding M.B., Dr. Brauner's testimony that persisting with Hibbald's maneuver for longer than 60 seconds would fall below minimally acceptable standards has been credited, but the evidence was not clear and convincing as to the exact length of time Dr. McCarthy applied traction. Petitioner's proposed findings of fact Nos. 17, 22, 26, and 28 and 29 regarding M.B. pertain to subordinate matters. With respect to petitioner's proposed findings of fact Nos. 21 and 23 regarding M.B., the evidence did not clearly and convincingly establish that respondent's use of the Hibbald maneuver caused the brachial plexus palsy, although it is entirely possible that it did. With respect to petitioner's proposed finding of fact No. 24 regarding M.B., the evidence showed that Dr. McCarthy intervened to accelerate delivery of the head, but his deployment of the vacuum extractor was not alleged to have been below standards, and may well have been justified by the intermittently depressed pulse the baby exhibited and the mother's difficulty pushing. Respondent's proposed findings of fact Nos. 1, 2, 3, 4, 10, 12, 14, 15, 20, 27, 28, 29, 30, 31, 32, 37 and 40 have been adopted, in substance, insofar as material. With respect to respondent's proposed finding of fact No. 5, C.H. arrived at the hospital before 5:45. Respondent's proposed findings of fact Nos. 6, 7, 8, 9, 11, 17, 18, 22, 33 and 34 pertain to matters that are subordinate or immaterial altogether. With respect to respondent's proposed finding of fact No. 13, Wood's maneuver requires pressure on the shoulders, not the head. With respect to respondent's proposed finding of fact No. 16, use of the vacuum extractor preceded knowledge of the shoulder dystocia. With respect to respondent's proposed findings of fact Nos. 19 and 21, he did not perform the maneuver properly. With respect to respondent's proposed finding of fact No. 23, the "clarification" has not been credited. With respect to respondent's proposed findings of fact Nos. 24 and 25, the obstetrician does not have discretion to fail to meet minimum standards. With respect to respondent's proposed finding of fact No. 26, the precise etiology of the brachial plexus palsy was not established. With respect to respondent's proposed findings of fact Nos. 35, 36, 38, 39, and 41, petitioner failed to prove clearly and convincingly that respondent's management of the shoulder dystocia in M.B.'s case fell below standards, but neither did the evidence establish that it met standards. COPIES FURNISHED: Gerald B. Sternstein, Esquire 600 First Florida Bank Building Post Office Box 2174 Tallahassee, FL 32316-2174 Richard A. Grumberg, Esquire Department of Professional Regulation 1940 N. Monroe Street Tallahassee, FL 32399-0750 Jack McRay General Counsel 1940 North Monroe Street Tallahassee, FL 32399-0792 Dorothy Faircloth Executive Director Department of Professional Regulation Medicine Board 1940 North Monroe Street Tallahassee, FL 32399-0792
