Findings Of Fact The Respondent is a licensed physician in the state of Florida, and holds license number ME 0034710. Respondent's last known address is 1430 Mason Avenue, Daytona Beach, Florida, 32117-4551. At all times material to these proceedings, Respondent, who is both a neurologist and a psychiatrist, specialized in the diagnosis and treatment of headaches in his medical practice with Daytona Neurological Associates in Daytona Beach, Florida. At various times from approximately May 18, 1984, through December 23, 1988, Respondent rendered neurological care to Patient C.R., a female born on November 14, 1963. On May 18, 1984, when C.R. initially came to Respondent's office complaining of severe headaches, Respondent noted in his medical records that the patient had been on birth control pills for three years and had ceased taking them two months prior to this visit. C.R. was also a cigarette smoker. From approximately May 18, 1984, until September 12, 1986, C.R. was prescribed a variety of medications at various times by Respondent for the patient's headaches. The medications included Asendin, Phrenilin Forte, Norpramin, and Tylenol #3. Medrol, Prednisone, and Decadron are legend drugs as defined in Section 465.003, Florida Statutes, and contain both natural and synthetic adrenocortical steroids (glucocorticoids). On September l2, 1986, Respondent prescribed a Medrol Dosepak unit to C.R. A Medrol Dosepak is a corticosteroid specific package that is tapered over six days from the first dose down to the last dose and contains a total of 84 mg of methylprednisolone (105 mg Prednisone equivalent). The medication was concluded on or about September 17, 1986. On October 30, 1986, Respondent prescribed another Medrol Dosepak unit to C.R. The patient took the Medrol tablets beginning on this date, in decreasing dosages, starting at 24 mg and ending at 4 mg six days later, for a total of another 84 mg of methylprednisolone (105 mg Prednisone equivalent). Both prescriptions of Medrol (September 12, 1986 and October 30, 1986) were short courses and treatment was not inappropriate. On November 7, 1986, C.R. went to a hospital emergency room where she was prescribed Prednisone 40 mg for three days and 20 mg for four days and referred back to the Respondent for follow-up care. During this hospitalization, C.R. received approximately 200 mg of Prednisone. On November 14, 1986, Respondent saw C.R. in his office and indicated in his records that the patient seemed to be doing better on Prednisone and "[w]e will keep her on this medication and re-evaluate her in one month. She is to . . . decrease the Prednisone and come off this in about a week or two." On November 25, 1986, Respondent saw C.R. in his office. Respondent indicated in his records that he would keep C.R. on Prednisone l0 mg daily for "another week or so." From November 7, 1986 until November 30, 1986, C.R. received a total of 465 mg of Prednisone. Appropriateness of corticosteroid use varies with both amount and duration. The amount initiated in the Emergency Room on November 7, 1986, was not excessive, but Respondent's rationale for continuation of the drug, or whether the November 14, 1986 dosage was tapered or less than that previously prescribed for C.R. in the emergency room, is not documented in Respondent's patient records. On January 20, 1987, Respondent saw C.R. in his office and documented that he was going to give the patient another "short course" of Prednisone. Respondent saw C.R. again in his office on January 30, 1987, and documented further prescription of Prednisone. The documentation for the above two visits does not indicate the dosage details nor suggest what circumstances of the patient's condition justify again prescribing prednisone other than the remark dated January 20, 1987, that "[p]atient is having some headaches again." For the period of January 20, 1987 through February 9, 1987, C.R. was prescribed a total of 510 mg of Prednisone. Petitioner's Exhibit 5 is a calendar prepared by C.R. which allegedly documents the patient's receipts for prescriptions which she purchased upon Respondent's authorization. C.R. has no independent recollection of amounts or times when she took the medications. On the basis of information reflected on the calendar, Petitioner seeks to establish that Respondent prescribed corticosteroids for C.R. in excess of that otherwise established by the evidence in this case. In view of the lack of C.R.'s independent recollection of when she took the medications, the lack of corroborating original receipts, C.R.'s lack of detail recall concerning her treatment by Respondent, her inability to remember when she prepared the calendar other than in preparation for civil litigation against Respondent following her treatment, and lack of other direct evidence corroborating the document's veracity, the calendar standing alone is not credited for the purpose of establishing amounts and times of medication prescribed for C.R. by Respondent. C.R. had an office visit on March 18, 1988 but there is no reference to any Prednisone prescription in the medical record. A handwritten note for the date of April 6, 1988 in the Respondent's medical record states that the patient was "told to stay on Prednisone." Respondent conceded in testimony that he apparently failed to document prescribing 60 mg Prednisone in April of 1988. From April 27, 1988 through May 8, 1988, Respondent had C.R. admitted to Halifax Medical Center in Daytona Beach, Florida. During that period, she received 909 mg. Prednisone equivalent (Decadron). Respondent discharged the patient with a diagnosis of severe vascular migraine headaches under control with a combination of Mellaril and Procardia. At the time of the April, 1988 admission, C.R. was suffering from crescendo migraine with numbness, blurring, and an episode of loss of consciousness. As established by testimony of Thomas M. Zizic, M.D., Respondent's expert in avascular necrosis, corticosteroid use, and treatment of headache, patients with the symptoms displayed by C.R., when she was hospitalized in April of 1988, are at risk for transient ischemic attacks and strokes. As opined by Dr. Zizic, and corroborated by testimony of Victor B. Robert, M.D., the short course of less than two weeks of high dose steroids in the course of the April, 1988 hospitalization was not inappropriate. Zizic also opined that the other courses of steroids prescribed previously for C.R. were not inappropriate. As established by Zizic, steroid medications in the amounts and duration prescribed for C.R. are not causative of avascular or aseptic necrosis. Dosage amounts of these drugs have to be much greater and for longer periods of time to occasion such side effects. Even assuming C.R.'s calendar of medications and the resultant supposition that she ingested more steroid medication than is established by the credible evidence, Zizic opined that the likelihood that such medication amounts and duration resulted in C.R.'s development of aseptic necrosis is less than five percent. Zizic also testified that he would not have felt it necessary to warn C.R. of the potential for avascular or aseptic necrosis in view of the remoteness of such a possibility at dosages prescribed for her. Dr. Jacob Green, an expert witness presented by Respondent, is a neurologist who provided insight into the clinical management of the difficult headache patient, noting that there is no standard treatment for such patients, "[y]ou just have to use what works . . . Its a matter of trial and error in a lot of cases." Green also noted that once a patient is treated with corticosteroids, the dosages must be tapered gradually, not stopped suddenly. Green concluded C.R.`s dosages were decreased appropriately, that duration of Medrol and Prednisone prescribed for the patient was appropriate, and that use and duration of Decadron during C.R.`s hospitalization in April, 1988, was also appropriate. While Green acknowledged that avascular necrosis of the hips is a known complication of steroid use, he testified that in 1986 or 1987 he would not have felt that failure to warn a patient about the potential for such a remote side effect constituted a breach of the standard of care and would not have warned the patient. In Green's opinion, Respondent did not prescribe Medrol, Prednisone or Decadron contrary to the best interests of C.R. In 1989, C.R. was diagnosed with aseptic necrosis of the femoral head of both her hips and underwent surgery in 1989 and 1990 resulting in total hip replacements. She has undergone surgery for "a revision on the left side" and continues to have problems. While differing expert testimony presented in this proceeding fails to clearly and convincingly establish a causal connection between the steroid medications given to C.R. and her resultant physical problems, the common consensus of those experts is that avascular necrosis is a complication that can arise from the use of steroids, given sufficient dosages and duration of such medication. Although Respondent did not inform C.R. of the potential of avascular necrosis from corticosteroid dosing by the prescribed medications and did not at any time during the course of his treatment discuss with CR the potential for such harmful side effects, the evidence fails to establish that the patient should have been informed in 1986 regarding the remote potential for harmful side effects of such medications. However, Respondent's medical records on the patient C.R. were inadequate. The records did not serve as an effective basis for planning patient care and providing for continuity in the evaluation of the patient's condition and treatment. The records did not furnish documentary evidence of the course of the patient's medical evaluation, treatment, and change in condition. Detail of the records was not sufficient to clearly demonstrate why one course of treatment was undertaken in preference to another course and would not have communicated sufficient information for any other practitioner who would have assumed the patient's care.
Recommendation ACCORDINGLY, it is recommended that a final order be entered finding the Respondent guilty of count two of the Administrative Complaint, violation of Section 458.331(l)(m), Florida Statutes; requiring as a penalty that Respondent's license to practice as a physician in the State of Florida be placed on probation for a period of one year upon conditions prescribed by the Board of Medicine; and further requiring that Respondent pay a fine in the amount of $5,000. DONE and ENTERED this 26th day of February, 1996, in Tallahassee, Leon County, Florida. DON W. DAVIS, 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 26th day of February, 1996. APPENDIX CASE NO. 94-2116 In accordance with requirements of Section 120.59, Florida Statutes, the following constitute my rulings with regard to proposed findings of fact submitted by the parties. Respondent's Proposed Findings. 1.-2. Accepted. Rejected, unnecessary. Rejected, subordinate to HO findings. Accepted, but not verbatim. While the calendar was admitted, it may only be used to corroborate direct testimony. C.R. had no independent recollections which could be corroborated by the calendar. Respondent took issue with the calendar, consequently the calendar is not credited as a basis for fact finding with the exception of Dr. Zizic's opinion regarding dosage levels. Incorporated by reference. 7.-10. Rejected, subordinate to HO findings. 11. Accepted, not verbatim. 12.-15. Incorporated by reference. 16.-18. Accepted. 19.-22. Rejected, subordinate to HO findings. Petitioner's Proposed Findings. 1-4. Accepted. 5. Rejected, unnecessary. 6.-9. Accepted, not verbatim. 10. Accepted in part, remainder rejected as subordinate. 11.-12. Accepted. 13.-19. Rejected, subordinate to HO findings. 20.-22. Accepted. 23.-25. Rejected, subordinate to HO findings. COPIES FURNISHED: Albert Peacock, Esquire Department of Business and Professional Regulation 1940 North Monroe Street Suite 60 Tallahassee, Florida 32399-0792 Donna J. Torsney, Esquire Donald W. Weidner, P.A. 10161 Centurion Parkway North Suite 190 Jacksonville, Florida 32256 Jerome W. Hoffman, General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308-5403 Dr. Marm Harris, Executive Director Agency for Health Care Administration Division of Medical Quality Assurance 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue The issues are: 1) whether Respondent committed medical malpractice, in violation of section 458.331(1)(t)1.; 2) whether Respondent failed to keep or maintain medical records, in violation of section 458.331(1)(m); 3) whether Respondent performed a wrong procedure or wrong-site procedure, in violation of section 456.072(1)(bb); and 4) if so, the determination of the penalty, pursuant to Florida Administrative Code Rule 64B8-8.001. (All references to statutes and rules are to the Florida Statutes and rules in effect in 2012, as cited in the Amended Administrative Complaint.)
Findings Of Fact Respondent is a medical physician, holding license number ME 0062034. He is certified as a pain management specialist by the American Board of Anaesthesia and American Academy of Pain Management. Licensed for nearly 40 years, Respondent practiced in 2012 in Lake Worth at the Palm Beach Pain Management Center, where he was the chief executive officer. Respondent has performed the specific procedures involved in this case at least 500 times and many thousands of epidural injections. Respondent's expert witness was Dr. Brett Schlifka, who is an osteopathic physician licensed in Florida and practicing in Wellington. Dr. Schlifka is certified by the Board of Neurosurgeons of the American College of Osteopathic Surgeons. As a neurosurgeon, Dr. Schlifka performs epidural injections, but never of hypertonic saline, so he was unable to address in any detail the epidural injection of hypertonic saline, nor does he use a catheter in performing epidural steroid injections (ESIs), so he was unable to address in any detail the specifics of the processes of threading a catheter through epidural space and inadvertently into intrathecal space and administering injectates through a catheter. Dr. Schlifka and Respondent are friends and refer patients to each other. Petitioner's expert witness was Dr. Harold Cordner, who is a medical physician licensed in Florida and practicing in Sebastian. Dr. Corner is certified by the American Board of Anesthesiology with an added qualification in Pain Management. For ten years, he has served as a clinical assistant professor at the Florida State University School of Medicine, where he teaches procedures such as those involved in this case--procedures that he himself has performed many times. This case involves procedures performed by Respondent on M.S.'s back on September 28, 2012. From bottom to top, relevant vertebra are sacral 1 (S1), lumbar 5 (L5), L4, L3, L2, and L1. Above the lumbar vertebra are thoracic vertebra, which are not directly pertinent to this case. The spinal cord extends no lower than L1/L2; the tapered end of the spinal cord is known as the conus. Relevant anatomical features in the area of the lumbar vertebrae, from the exterior to the interior, are ligaments, the epidural space, the dura, the subdural space, the arachnoid, the subarachnoid space, and the spinal cord. The subdural space is potential, presumably responding to changes in posture or movement, or even theoretical, because the epidural and subarachnoid spaces may be separated by less than one mm. Cerebral spinal fluid (CSF) is present in the subarachnoid space, but not the epidural space. The subarachnoid space is also known as the intrathecal space, so an intrathecal injection is an injection into the subarachnoid space. Intrathecal injections may be intentional or inadvertent, although this case does not involve any intentional intrathecal injections. "Bilateral" refers to the left and right sides of the vertebrae on the left and right sides of a patient's body. "Transforaminal" is across the space, within the epidural space, occupied by the foramen, which is a bony structure at each vertebral level through which spinal nerves pass. This case involves epidural injections of various injectates, including steroids--i.e., ESIs--although an ESI routinely includes the epidural injection of contrast and an anaesthetic in addition to a steroid. The ESIs in this case all involve lumbar transforaminal ESIs, so any reference to an "ESI" is to a lumbar transforaminal ESI. The alternative to a transforaminal ESI is an interlaminar ESI, which is an ESI within the space between vertebrae. At the time in question, at least, an interlaminar ESI was a safer procedure than a transforaminal ESI, if, for no other reason, than the proximity of an artery to the nerve passing through a foramen and the possibility of causing an infarction of the spinal cord by an inadvertent injection into the artery. M.S. was a patient of Respondent at the Palm Beach Pain Management Center from 2006 through September 28, 2012. On the latter date, Respondent performed procedures on M.S., immediately after which she has been left paralyzed in her lower extremities and incontinent of bladder and bowel. Born in 1951, M.S. presented to Respondent in 2006 with complaints of low back pain for many years. She had undergone failed back surgeries in 1989, 1993, and 2003. In the course of these surgeries, surgeons had performed spinal fusions of L3/L4 and L4/L5 and implanted hardware at L3/L4. M.S. was five feet, two inches tall and weighed 160 pounds. At the time of M.S.'s initial office visit on February 7, 2006, M.S. described the pain in her low back as ranging from 5 to 10 on a scale of 0-10 and stated that she had not had "injection therapy" recently. Respondent's impressions included lumbar failed back surgery syndrome and lumbar radiculopathy, which is a condition in which a compressed spinal nerve causes pain along the nerve. Respondent recommended a bilateral ESI. Imaging conducted shortly after the initial office visit revealed the above-mentioned hardware, postoperative changes in the disc at L4/L5, a mild disc bulge at L1/L2, a "very minimal" posterior disc bulge at the postoperative site of L3/L4, and a small central protrusion at L2/L3 causing a mild compression along the central aspect of the thecal sac, which is within the subarachnoid space. Besides the initial office visit and some imaging reports from late 2010, the evidentiary record contains Respondent's medical records only from December 2011 through September 28, 2012. In late 2010, imaging disclosed disc degeneration at L1/L2 and L2/L3 with mild thecal sac impingement, the surgical fusion of L3/L4 and L4/L5, and disc desiccation at L5/S1. There was also thickening or clumping of nerve roots through the surgical levels that could be regarded as arachnoiditis, which is inflammation of the arachnoid membrane. However, the evidentiary record contains billing records from late 2006 through September 28, 2012. These records indicate that Respondent performed 21 epidural injection procedures on M.S. from December 6, 2006, through September 28, 2012. The last ten such procedures, from April 19, 2010, were billed as ESIs using Code of Procedural Terminology (CPT) code 64483, although one procedure was billed as CPT code 64473. Respondent also billed ESIs under CPT code 64483 or 62311 on February 6, 2008, May 15, 2009, May 29, 2009, and February 22, 2010. The remaining procedures were billed on December 6, 2006, March 20, 2007, June 13, 2007, November 8, 2007, February 21, 2008, September 5, 2008, January 9, 2009, and October 30, 2009, under CPT code 62264 as "Racz" procedures, which are described below. Among other things, these records establish that Respondent performed ESIs on M.S. on 90-day intervals from late 2010 until September 28, 2012. Obviously, the billing records also establish that the lumbar region of M.S. was the site of numerous procedures over the six years leading up to September 28, 2012. Although the experts agree that M.S.'s lumbar epidural space was challenging due to myriad deformities following years of disease and multiple surgeries, Respondent had navigated this space over 20 times, so Respondent at least knew that he would encounter, if not where he would encounter, lesions, narrowed openings, and other pathological changes. For many years, Respondent had prescribed Percocet to control pain. The medical records for the nine months preceding the September 28 procedures indicate that Respondent consistently administered drug screens, which appropriately revealed only oxycodone. However, on at least a half dozen office visits during 2012, M.S. admitted that she was not abiding by the Narcotic Treatment Agreement, but, each time, Respondent's notes misstate that she was in compliance, so as to indicate no inquiry into the details of the noncompliance or its significance, if any, and recordkeeping by rote. Respondent likewise displayed inattention to detail as to the informed consents that he obtained from M.S. during this nine month timeframe. Each informed consent contains a handwritten description of the procedure to which M.S. was consenting by signing the form. For each procedure, the procedure is "lumbar transforaminal epidural steroid injections with fluoroscopy and catheter"; the June 25 informed consent rephrases the last four words as "with catheter with fluoroscopy," and the September 28 informed consent adds "left" to the typical description of the procedure. Respondent never obtained M.S.'s informed consent for the injection of hypertonic saline, even though Respondent injected hypertonic saline, with the amounts shown parenthetically, during the procedures of December 23 (5 cc), June 25 (5 cc), and September 28 (8 cc). For the December 23 procedures, Respondent took 12 minutes from "start" to "end" for the actual procedures and 18 minutes from "in" to "out" of the operating room. Coincidentally, the December 23 procedures' start and end and in and out times are identical to these times for the September 28 procedures. The start to end times of other two procedures were 11 minutes. This brisk pace betrays Respondent's experience as a pain specialist, but belies M.S.'s challenge as a patient. During each set of procedures from December 2011 through September 28, 2012, Respondent injected the same injectates, except for the March 23 procedure that omits hypertonic saline, but at different dosages, which is discussed below. Respondent used a form that allowed him to document his surgical plan by circling levels--L1/L2, L2/L3, L3/L4, and L5/S1--and sides--left, right, and bilateral. For December 2011, Respondent circled nothing; for March and June 2012, Respondent circled levels L3/L4, L4/L5, and L5/S1 and the right side; and for September 28, 2012, Respondent circled the same levels, but the left side. The efficacy of the epidural procedures is revealed in the notes from postsurgical office visits during which M.S. described her pain. On January 2, 2012, M.S. reported that her pain ranged from 6-10 all day and all night, the pain ranged from her back down her legs, everything made her pain worse, and the injections helped, although, after several injections, she reported that she had experienced "floppiness" in one leg--side unspecified. M.S. concluded that the pain relief from the injections made a difference in her life and restored functionality. On January 10, 2012, M.S. returned to Respondent's office complaining of pain ranging from 8-10 without medications and 6-10 with medications. The pain was radiating from her low back down her legs, mostly her right leg. The pain was continuous and "sharp, burning, shooting, achy, knife-like, stabbing, deep, heavy, and gnawing." On February 7, 2012, M.S. returned to Respondent's office with the same complaints. Interestingly, on March 6, 2012, M.S. returned to Respondent's office describing her pain as improved--5-10 without medications and 3-6 with medications. This time the note specifies that "transforaminal epidurals" gave her the greatest relief. The note for this office visit mentions a treatment plan of another ESI of a steroid and anaesthetic, but does not specify the side. On April 3, 2012, M.S. returned to Respondent's office for her first visit after the March 23 ESI. Again, the pain was worse immediately after the procedure--9-10 without medications and 5-8 with medications, although the note adds, "the transforaminal epidural with catheter has also helped her tremendously." The notes contain no analysis of the worsened pain 11 days after the ESI compared to 17 days before the ESI, but leg floppiness does not recur in this or any subsequent note. On May 5, 2012, M.S. returned to Respondent's office describing her pain as 8-10 without medications and 5-9 with medications. M.S. stated that the medications and "transforaminal epidurals with catheter" were the only treatments that helped with the pain. On May 15, 2012, M.S. returned to Respondent's office describing her pain as 6-10 without medications and 4-6 with medications. On June 22, 2012, M.S. returned to Respondent's office following a trip to North Carolina, where she had been unable to obtain her oxycodone and had been in considerable pain. On the day of the visit, though, M.S. reported her pain to be an 8 without medications and 6 with medications. The treatment plan contained in the note includes a right ESI, which Respondent described to M.S. as the injection of Cortisone and Marcaine or lidocaine with no mention of hypertonic saline. On July 20, 2012, M.S. returned to Respondent's office for her first visit after the June 25 ESI. M.S. described the pain as 8-10 without medications and 5-8 with medications. The recent "right lumbar transforaminal with catheter [helped] about 50% to 60%." On August 17, 2012, M.S. returned to Respondent's office describing her pain as 7-10 without medications and 1-7 with medications. The note adds, "She states no real change in her status, just looking forward to another injection." The treatment plan was for a left ESI with Cortisone and Marcaine or lidocaine, but, again, with no mention of hypertonic saline. On September 28, 2012, Respondent performed three procedures-- first, a caudal lumbar epidurogram with interpretation; second, an ESI; and, third, a distinct procedure involving the injection of hypertonic saline. In all three procedures, Respondent relied on live or real-time fluoroscopy to guide the spinal needle and catheter, which are described below. M.S. was positioned on a table, which, as relevant to these procedures, accommodates the 90-degree rotation of a fluoroscope, which is also called a C-arm due to the ability of the device to project onto a monitor anterior-posterior (AP), lateral, and oblique views of the spine and related structures. The AP view is a head-on (or back-on) view, and the lateral view is a side view at 90 degrees from the AP view. At the direction of Respondent, a technician not only rotated the C-arm, but also captured a still image from the radiographic output, which otherwise ran live or in real time or was switched off entirely when unneeded, to avoid over-exposing the patient to radiation. The caudal lumbar epidurogram is a relatively simple diagnostic procedure. Respondent passed a spinal needle through the sacral hiatus, which is a hole in the bony structure at the base of the spine below S1, and into the caudal epidural space. By lightly pushing the syringe plunger, Respondent employed the loss-of-resistance technique to sense the lack of resistance characteristic of the epidural space; by lightly pulling the syringe plunger, Respondent aspirated the needle and line to rule out the presence of any CSF, which would reveal an intrathecal penetration, or blood, which would reveal a vascular penetration. M.S., who remained conscious during the procedures, also did not indicate any paresthesia, which is numbness or tingling. Respondent withdrew the hollow core of the spinal needle in preparation for threading the catheter through the now-hollow needle and up through the epidural space. Respondent has maintained five AP views and one lateral view from the fluoroscopic imagery that he conducted on September 28. The lone lateral view, which is of the sacrum, was taken and preserved as part of the epidurogram. During the entirety of the September 28 procedures, including the epidurogram, Respondent injected 6 cc of contrast in the form of Omnipaque 300. As with all injectates, Respondent's records refer only to divided doses, so it is impossible to know how much of any injectate, including the contrast, that he administered at what level. The ESIs in March and June 2012 may have involved fewer levels than the ESIs in December 2011 and September 2012, because the former involved 3 cc each of Omnipaque and the latter involved 5 cc each of Omnipaque. Returning to the epidurogram, as the contrast flowed up the epidural space, the radiography revealed lesions at S1 on the right and L5 on the left. The dispersal pattern of the contrast indicated that the contrast was within the epidural space. Without incident, Respondent completed the epidurogram about two minutes after starting the procedure. For the ESI and hypertonic saline procedures, Respondent passed the catheter up through the epidural space to the level or levels that he was targeting for treatment. At each level, Respondent injected, in order, the above-described contrast, an anaesthetic, a steroid known as Depo Medrol, and hypertonic saline solution. For all four procedures from December 2011 through September 28, 2012, Respondent used Marcaine 0.25% and lidocaine 1%, but his records did not indicate the location at which he administered each anaesthetic. It appears that the anaesthetic used in the greater dose was used in the epidural space, and the other anaesthetic was used elsewhere, likely at the site of the initial injection. If so, for the September 28 procedures, Respondent used 5 cc of lidocaine in the epidural space--or what he intended to be the epidural space--and 1 cc of Marcaine elsewhere. In March 2012, Respondent used 3 cc of Marcaine and no lidocaine; in December 2011, Respondent used 5 cc of each anaesthetic; and, in June 2012, Respondent used 2 cc of Marcaine and 3 cc of lidocaine. Respondent's use of Depo Medrol was more consistent. He administered 80 mg during the September 28 ESI, but had used 120 mg during each of the three preceding ESIs. The greatest variability occurred with the hypertonic saline, which, as already noted, was omitted from the March 2012 ESI. Respondent administered 8 cc of hypertonic saline during the September 28 procedures and only 5 cc--nearly 40% less--during the December 11 and June 2012 procedures. The record contains no indication of why he failed to inject hypertonic saline during the March 12 procedure, but the sole reference to leg floppiness, as noted above, was after the preceding procedures in December 2011. There is some dispute in this case as to what may be injected as part of an ESI. Obviously, the ESI contemplates the injection of a steroid, as well as contrast and an anaesthetic, which support the injection of the steroid by heightening the safety of the ESI and the comfort of the patient during the ESI. Also, these injectates are amenable to grouping because this record does not suggest that an inadvertent intrathecal injection of these injectates, even at the doses intended for the epidural space, affects patient safety nearly as much as an inadvertent intrathecal injection of hypertonic saline. An intrathecal injection of a very high dose of anaesthetic could proceed up the spinal canal and cause respiratory and cardiovascular collapse, but the record does not indicate that such dangers exist for the dosages involved in the September 28 procedures. For the same reason, an ESI may include an injection of normal saline, which is harmless in the subarachnoid space. The epidural injection of hypertonic saline is the distinguishing feature of a Racz procedure, which also involves an epidural injection. Named after its physician-developer, Gabor Racz, the Racz procedure is intended to break up, or lyse, epidural lesions or adhesions that may be the source of part or all of a patient's pain when a nerve is trapped by an adhesion. In the Racz procedure, a physician injects hypertonic saline near the lesion. The salinity of hypertonic saline solution is ten times greater than the salinity of ambient conditions in the body, so the hypertonic saline solution, by osmosis, causes the body to compensate for the sudden appearance of hypersaline conditions by delivering fluid that expands the space and may thus lyse any nearby adhesions. Although the catheter is typically not stiff enough to break up lesions mechanically, such mechanical lysis may also occur incidentally while performing a Racz procedure. Other distinguishing features of an ESI and Racz procedure involve the sources of pain and the term of pain relief. The lysis of an adhesion permanently eliminates one potential source of pain--a nerve trapped by an adhesion. An ESI reduces inflammation wherever it may be present, so it treats a wider range of conditions, but offers only temporary relief. The pain relief from the steroid may extend weeks or months. The pain relief from the anesthetics--one hour for lidocaine and four hours for Marcaine--is not intended to persist past the intra-operative and recovery stages of the procedures. There may also be a locational difference between the ESI and Racz procedures. As noted above, in the ESI, the catheter traverses the foramen within the epidural space, and, in the Racz procedure, the catheter is threaded to lesions anywhere within the epidural space. Dr. Cordner opined that Respondent failed to perform an ESI due to the lack of proximity of the injection sites to the various foramina. Labels notwithstanding, the procedures performed by Respondent on September 28 substantially conformed to an ESI and, because an ESI does not include the epidural injection of hypertonic saline, a Racz procedure. Determining that Respondent performed two distinct procedures in addition to the epidurogram does not answer several relevant questions. First, which injectate, once introduced into the subarachnoid space, injured M.S.? If introduced to the subarachnoid space, the hypertonic saline is a known cause of the paralysis and incontinence that M.S. suffered, such as myopathic injury resulting in paralysis. Because safe practices, as described by Dr. Cordner below, include the provisional injections of contrast and anaesthetic to confirm that a catheter tip is safely in the epidural space, the only other injectate that might injure the patient is the steroid, but, again, the record is silent on the consequence of the introduction of the Depo Medrol, at the dosages used by Respondent, into the subarachnoid space. Second, when did Respondent decide to inject the hypertonic saline? The record provides no basis to answer this question. As noted above, Respondent did not administer hypertonic saline in the March 2012 procedure, but administered hypertonic saline in the December 2011 and June 2012 procedures, as well as the September 28 procedure, in which he increased the dose by 60%. For none of the three procedures in which Respondent injected hypertonic saline did his treatment plans or informed consents mention hypertonic saline. Respondent may have decided, prior to the day of surgery, to use hypertonic saline and merely failed to document this decision in advance, or he may have decided, during surgery, to use hypertonic saline and documented the use of hypertonic saline as noted above. Third, why did Respondent inject hypertonic saline and why did he administer the dosages that he used? The record provides no basis to answer these questions, although, as noted above, the omission of hypertonic saline from the March 2012 procedure corresponds to leg floppiness after the December 2011 procedure and the increased dose of hypertonic saline in the September 28 procedures corresponds to a lower dose of the Depo Medrol. The medical records indicate that M.S. believed that the ESIs relieved her pain, but she could not have had a preference about hypertonic saline because she evidently never knew that Respondent was using this injectate. On the other hand, M.S.'s rating of her pain after the March 2012 procedure, without hypertonic saline, was not much different from her rating of her pain after the December 2011 and June 2012 procedures. The likely inference is, if Respondent's use of hypertonic saline were not arbitrary or capricious, he injected hypertonic saline, at least when M.S. had not mentioned leg floppiness after the last injection of hypertonic saline, because he believed it worked and used considerably more of it on September 28 because he believed that more would work better. Returning to the remaining September 28 procedures, Respondent injected the four injectates described above on M.S.'s left side at three levels: S1/L5, L4/L5, and L3/L4. At each level, Respondent waited three or four seconds after injecting the contrast, while he watched the radiographic output, before injecting the anaesthetic, after which he waited 30 to 40 seconds to allow the anaesthetic to numb the area. Then, Respondent injected the steroid, waited five seconds, and lastly he injected the hypertonic saline. Assisted directly by the epidurogram, Respondent properly located the catheter tip in the epidural space at S1/L5. The evidence is mixed as to the location of the catheter tip at L4/L5, but the catheter tip was in the subarachnoid space at L3/L4. As Dr. Cordner testified, an inadvertent penetration of the subarachnoid space by a catheter tip is not evidence of negligence; the negligence arises in what a physician does or fails to do after such an intrathecal penetration. Here, the reasons why Respondent failed to realize that the catheter tip was in the subarachnoid space at L3/L4 relate to the reasonable precautions that Respondent failed to take--and thus establish Respondent's negligence. Respondent failed to realize that the catheter tip had entered the subarachnoid space at L3/L4 because, after injecting the contrast, he misread the AP real time view from the fluoroscope that showed a dispersal pattern suggesting that the contrast was not within the epidural space; because, after injecting the contrast, he did not direct the technician to obtain a lateral real time view, which would have provided another dimension, so as to confirm that the contrast was not in the epidural space; because he did not perform the loss-of-reduction technique, which would have confirmed that the catheter tip was not in the epidural space; because he did not aspirate the catheter and line, which would have revealed CSF; and because, after injecting the anaesthetic, he did not wait at least 15 minutes to rule out a gross motor block of the lower extremities, which would have indicated that the catheter tip was in the subarachnoid space. Unreasonably unaware that the catheter tip was in the subarachnoid space, Respondent injected the steroid and hypertonic saline, withdrew the catheter, and completed the ESI and Racz procedures within ten minutes from the end of the epidurogram procedure and turned over responsibility for M.S. to Respondent's nurse. One minute after the completion of the procedure, at 9:38 a.m., M.S. complained of pain in her hips and legs, and Respondent administered 60 mg of Toradol. Ten minutes later, M.S. stated that both of her legs were numb, although by 10:15 a.m. she was moving both legs. By 11:30 a.m., she could move both legs, but had no feeling from the top of her thighs down. By 1:00 p.m., M.S. reported feeling to her mid-calf, but, three hours later, she could not move her legs. Although Respondent justifiably had not been concerned about transient numbness, the deterioration in the ability to move the legs concerned him, and Respondent insisted that M.S. be admitted to a nearby hospital. Respondent thus discharged M.S. at 5:25 p.m. for transfer by ambulance to Bethesda Memorial Hospital (Bethesda), where other physicians assumed responsibility for her care. Imaging conducted at Bethesda upon the admission of M.S. revealed no epidural hematomas, but evidence of arachnoiditis, which is inflammation of the arachnoid membrane. Most significantly, a lumbar CT scan revealed a small amount of air in the subarachnoid space, which was consistent with Respondent's recent intrathecal injections. Also, M.S.'s thecal sac displayed enhancement of disc disease at S1 through L4 suggestive of a recent subarachnoid injury. About six weeks after the procedures, an MRI at the JFK Medical Center (JFK) revealed conus medullaris syndrome posteriorly within the thecal sac at L1/L2 through L3/L4. This syndrome results from injury to the conus, such as from trauma, and is consistent with Respondent's intrathecal injection of hypertonic saline. This hospitalization followed a finding from an outpatient MRI of a large hematoma in the lumbar spine. Respondent and Dr. Schlifka contend that the Bethesda physicians missed the hematoma, but it is as likely that the hematoma formed after M.S.'s discharge from Bethesda. M.S. underwent a resection of a mass, which was found to be an arachnoid cyst. Post-operatively, M.S. still was unable to move her lower extremities, but started to regain sensation in her great toes. Respondent relies on a succinct affidavit from Dr. Racz himself, which, as noted in the Conclusions of Law, is available only to impeach Dr. Cordner's testimony. Dr. Racz's affidavit states that he has examined Respondent's medical records, including the six fluoroscopic images retained by Respondent; all of the images available in connection with the Bethesda and JFK hospitalizations; and some earlier images. From these materials, without more, Dr. Racz's affidavit concludes that Respondent's care was "appropriate and that he met or exceeded the standard of care throughout the lumbar transforaminal epidural steroid injection with catheter and fluoroscopy on September 28, 2012. Further, the complications suffered by [M.S.] are known risks and complications of the procedure that are not indicative of negligence." The most obvious difference between the opinions of Dr. Cordner and Dr. Racz is not the amount of work; each physician has examined all of the available medical records. But Dr. Cordner has painstakingly analyzed the September 28 procedures and Respondent's negligent actions and omissions, and Dr. Racz has declared by fiat that Respondent was not negligent. Undoubtedly, Dr. Racz learned from his examination of the medical records that Respondent injected hypertonic saline on September 28, yet Dr. Racz describes the procedure as an ESI and makes no mention of hypertonic saline. Perhaps Dr. Racz is sensitive to the greater potential for injury introduced by hypertonic saline, which is the prominent injectate of his procedure. Perhaps, the procedure followed by Respondent on September 28 failed to follow strictly the requirements of the Racz procedure. Dr. Cordner, who co-teaches the Racz procedure with Dr. Racz, testified that the procedure requires a physician to wait 15 to 30 minutes after injecting anaesthetic to confirm the injection is in the epidural space. Regardless, an informed opinion as to Respondent's negligence must take into account the injectate that, on this record, bears the clear potential for patient injury, and Dr. Racz's opinion fails to do so. Perhaps, Dr. Racz's affidavit is an expression of agreement with Dr. Cordner's concession that, in itself, an inadvertent intrathecal penetration is not evidence of negligence. But Dr. Racz's affidavit needs to account for the acts and omissions, set forth above, that simultaneously explain why Respondent failed to realize that the catheter tip was in the subarachnoid space at L3/L4 and constitute his failure to take these simple precautions against patient injury. The last sentence of Dr. Racz's affidavit dismisses M.S.'s "complications"--a veiled reference verging on a euphemism when describing permanent paralysis and incontinence--as known risks of the ESI and not indicative of negligence. Obviously, a bad result does not prove medical malpractice, although, as explained in the Conclusions of Law, the risk of a bad result and the impact on a patient of a bad result drive the precautions that a physician must take to avoid a finding of medical malpractice. On the other hand, the known risk of permanent paralysis and incontinence from a Racz procedure or an ESI with the injection of hypertonic saline does not obviate the necessity of analysis of the adequacy of the precautions taken by Respondent to avoid such a result; to the contrary, these grave consequences underscore the importance of such analysis. Notwithstanding Dr. Racz's status in the field of pain management, his affidavit is entitled to no weight whatsoever and fails to impeach the testimony of Dr. Cordner. Dr. Schlifka's testimony is better than Dr. Racz's affidavit in one respect: he clearly acknowledged that injectate had entered the subarachnoid space. It is impossible to dispute this fact based on M.S.'s dramatic response, the dispersal pattern of contrast depicted in one saved AP view, air found in the subarachnoid space shortly after the September 28 procedures, the injury to the thecal sac, and the conus injury. On the other hand, Dr. Schlifka's testimony shared the failure of Dr. Racz's affidavit in addressing the particulars of the September 28 procedures performed by Respondent. As Dr. Racz failed to focus on anything but a theoretical ESI, Dr. Schlifka failed to focus on anything but the fragile anatomy of the dura--never addressing, for instance, the likelihood that a catheter during an ESI could tear the dura--something that the experienced Dr. Cordner has never encountered; whether a tear would introduce air into the subarachnoid space; or whether the injectate entering through a tear could possibly injure the thecal sac and conus. Obviously, Dr. Schlifka lacks the experience to opine as to whether a catheter may tear the dura and, if so, the probability of this complication. On the other hand, Dr. Schlifka failed to explain why a dural tear would admit injectates into the subarachnoid space, but not allow injectates and CSF to escape from the subarachnoid space into the epidural space. Nor did he address the behavior of injectates--the most important one of which he has never worked with--if injected through the dura and into the subarachnoid space or if entering the subarachnoid space through a tear in the dura. Although qualified to advise that the dura may tear, and, as he testified, the dura may be more prone to tearing after numerous surgeries and procedures in the affected area, Dr. Schlifka clearly lacked the means to address, on these facts, the probability that M. S.'s injuries were caused by a dural tear or an intrathecal injection. Compared to Dr. Cordner's detailed analysis and superior relevant experience, Dr. Schlifka's opinions are speculative and perhaps reflective of an understandable desire to help a beleaguered friend. However, Dr. Schlifka's explanation for the intrathecal penetration of the injectate by a dural tear is rejected as unsupported by the evidence. For Count I, Petitioner proved that, based on the standard of care in effect in 2012, Respondent committed medical malpractice by failing to recognize that he was performing intrathecal injections of steroid and hypertonic saline at L3/L4. Petitioner failed to prove that any injections at L4/L5 and L5/S1 were intrathecal. The evidence of intrathecal injections at L3/L4 is set forth in paragraph 48, and Respondent's negligent acts and omissions are set forth in paragraph 37. The intrathecal injections of the contrast and anaesthetic at L3/L4 were wrongful solely because Respondent failed to use the information obtainable from these injections to discover that the catheter tip was in the subarachnoid space. In other words, Respondent would not have committed medical malpractice (or a wrong-site procedure or wrong procedure) if he had injected intrathecally contrast and an anaesthetic as part of what is intended to be epidural injections, as long as he learned from these injections that the catheter tip was in the subarachnoid space and moved the tip into the epidural space or terminated the procedure: the epidural injection of these injectates performs both a therapeutic and diagnostic function. For Count II, Petitioner failed to prove that, in 2012, Respondent was required to obtain and retain a permanent image of any lateral view of L3/L4 or any other location as part of the procedures after the epidurogram or that Respondent's failure to realize that the catheter tip was in the subarachnoid space violated his recordkeeping obligation. The latter point finds no support in the record. As for the images, Dr. Cordner's testimony on this "requirement" of medical recordkeeping was vague, conditional, and never tethered to the requirements in effect in 2012. Although his practice is different, Dr. Schlifka does not keep permanent views from his epidural steroid injections by needles. Petitioner itself seems to have missed the point that a permanent image of an AP view helped prove that the catheter tip was in the subarachnoid space at L3/L4. It is one thing to hold Respondent responsible for failing to interpret a real time AP view of L3/L4 and failing to obtain a real time lateral view of L3/L4, as discussed in connection with Count I, but it is another thing to hold Respondent responsible for failing to maintain permanent images of any views for the procedures following the epidurogram. Among myriad shortcomings in Petitioner's case for Count II is the failure to address whether, for reasons of cost or radiation exposure, a physician in 2012 could still perform a blind ESI and, if so, the ramifications of more elaborate and expensive recordkeeping requirements imposed on the physician who performed image-guided ESIs--or otherwise would do so, but for this expensive recordkeeping requirement. For Count III, Petitioner proved that Respondent performed a wrong procedure or a wrong-site procedure by injecting "injectate," but not contrast, into the intrathecal space when he intended to inject injectates into the epidural space. As noted above, an inadvertent intrathecal administration is not evidence of carelessness, and the timely detection of such a mishap--before the intrathecal injections of a steroid or hypertonic saline--may involve interpreting the dispersal of contrast or the effect of the anaesthetic and determining that either or both injectates have been accidentally injected into the subarachnoid space. For this reason, the inadvertent intrathecal injections of contrast or anaesthetic into the subarachnoid space is not a wrong procedure or wrong-site procedure because of the secondary diagnostic value of this otherwise-therapeutic procedure. The wrong procedure or wrong-site procedure occurred when Respondent then injected the steroid and hypertonic saline into the subarachnoid space at L3/L4; the intrathecal injections of these injectates lacked any diagnostic purpose and were thus wrong procedures or wrong-site procedures. In its proposed recommended order, Petitioner has proposed a reprimand, probation for two years, and a $30,000 fine. Despite the passage of seven years from the September 28 procedures and the transmittal of the file to DOAH, Petitioner failed to identify important features of this complicated case. Although not charged with these matters, Respondent was guilty of serious failures to obtain informed consent for the use of injectate that caused M.S.'s catastrophic injuries--hypertonic saline--and to keep medical records documenting his plans for an ESI or an ESI with hypertonic saline and the locations and dosages of each injectate during the procedures, as well as analysis of the efficacy of each set of procedures. These aggravating factors necessitate the imposition of a suspension. On the other hand, past discipline is not an aggravating factor. By final order entered April 20, 2006, the Board of Medicine fined Respondent for a failure to keep adequate medical records 20 years ago, but the failure was in performing adequate physical examinations, which is not an issue here. Given the age and nature of the offense, past discipline is irrelevant in this case.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order finding Respondent not guilty of the alleged violation of section 458.331(1)(n) in Count II, but guilty of the alleged violations of sections 458.331(1)(t)1. and 456.072(1)(bb) in Counts I and III, respectively, and imposing a reprimand, six months' suspension, two years' probation following the end of the suspension, and a fine of $20,000. DONE AND ENTERED this 18th day of November, 2020, in Tallahassee, Leon County, Florida. S ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 18th day of November, 2020. COPIES FURNISHED: Sharon Bidka Urbanek, Esquire Forman Law Offices, P.A. 238 Northeast 1st Avenue Delray Beach, Florida 33444-3715 (eServed) Michael J. Williams, Esquire Geoffrey M. Christian, Esquire Department of Health Prosecution Services Unit 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3565 (eServed) Louise St. Laurent, General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3565 (eServed) Claudia Kemp, J.D., Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin C-03 Tallahassee, Florida 32399-3253 (eServed)
The Issue The issues in this case are those promoted through an Administrative Complaint brought by the Petitioner against the Respondent charging the Respondent with possession of controlled substances and the sale and distribution of those substances. This alleged conduct on the part of the Respondent is said to have violated Section 401.411(2), Florida Statutes.
Findings Of Fact Jill D. Mitchell, Respondent, at all times relevant to this case, was the holder of an Emergency Medical Technician certificate and Paramedic certificate. This certification or licensure allows the Respondent to engage in activities related to those licenses within Florida. Briefly stated, an Emergency Medical Technician has the authority to perform basic life support functions. As an example, to stop bleeding, to apply splints, and to perform other non-invasive techniques related to patient treatment. By contrast, the Paramedic is empowered to do invasive techniques to include injecting drugs, performing I.V. therapy, opening oral airways, monitoring the patient's heartbeat and as need be, defibrillation. Prior to the present actions, Respondent has never been charged with any administrative violations pertaining to her licensure in the aforementioned fields. The Administrative Complaint which underlies this action dates from June 14, 1984. In particular, the complaint against the Respondent arose as an adjunct to a police investigation being conducted by the Brevard County, Florida Sheriff's Office and detectives from Baltimore, Maryland. On November 2, 1983, Officer Walter Kight, Jr., and another officer from the Brevard County Sheriff's Office, accompanied two detectives from Baltimore, Maryland to Grant, Florida, to question individuals on the subject of a homicide investigation in Maryland. When the officers arrived at the residence where they were to conduct the investigation, they discovered 400 pounds of suspected marijuana. As a consequence, a number of arrests were made related to this substance believed to be marijuana. After securing the residence, the officers began to receive calls concerning narcotics. There were fifteen to twenty of those calls and several callers were identified as being women. One of the persons who called said that her name was Jill. According to officer Kight, this person whose name was Jill asked if David was there. In response to the inquiry Kight states that he told the woman that David was not there, but David would be back later. Kight said the woman then asked if the "stuff" was there. Kight indicates that he said yes and that "he left it here for you". The officer recounts that the woman indicated that she gave David valium pills and placidyl, for his headaches, in exchange for a "hit". Again Kight indicates that he told the woman that "its here", that he left it "for us". The woman is then said to have quoted a price, "... that it was normally twenty-four dollars and something and she'd be right over driving a black Corvette to pick it up." Respondent arrived at the residence in question shortly thereafter, driving a black and silver Corvette. Kight met her out at the car. Kight reports that she asked if he were the person whom she had talked to in the telephone conversation. Kight said that he indicated that he was and then she asked that he get in the car. Kight said that she then indicated they would go for a ride and he told her that this would not be possible because there was "too much stuff" in the residence and that it could not be left. Kight states that Respondent then said that she needed a "fix" bad, because she had had a bad day and could they go into the bathroom. Per Kight's testimony they then went into the residence and into the bathroom within that residence. Once in the bathroom, per Kight's testimony, two bottles were taken from her purse which were identified as being valium and placidyl. Those bottles were placed on the counter. Kight states that there were several items in her purse such as a syringe, a spoon, things that would normally be used for narcotics. Kight says that the Respondent then asked him if he had "the stuff", and further stated that she needed a "hit". He says that he answered in the affirmative and that she gave him sixteen dollars in cash and stated that there were five other dollars in the car. Kight indicates that he said they would get that money later. Kight indicates that Respondent was then arrested for possession of a controlled substance and intent to sell a controlled substance. This arrest pertained to the valium and placidyl. Valium and placidyl are controlled substances. Kight testified that alleged reference to shooting-up on the part of the Respondent meant use of "heroin, coke or whatever is available." Kight says that the money mentioned before was given to him and that she had washed up in the sink and rolled up her sleeves. Kight indicates in his testimony, that the two bottles of pills, namely the bottle of valium and placidyl, were not handed to him but left on the counter. In that connection, Kight testifies that the Respondent indicated that the pills were ones which Dave needed for his headaches. Kight indicates that no request was made by the Respondent for payment for the valium and placidyl. Instead, at that moment, according to Kight, Respondent said, "This is what I have and I've got twenty-four dollars." Kight denies asking the Respondent if he could purchase the valium and placidyl from the Respondent. Later in his testimony Kight indicates that the transaction was one involving a trade where she would give him two bottles of pills and some money for some heroin. This was, according to Kight, a surmise on his part that heroin was being exchanged for, in that he felt that "stuff" referred to coke or heroin or whatever she might want. He acknowledges that the reference to "stuff", as he understood it, might have meant any substance. In a further point in his testimony, Kight indicates that Rospondent indicated that she normally deals with David and that David has bad migraine headaches and that she would give him valium pills for that and then he would fix her up with some drugs. Finally, in the course of the testimony at hearing, Kight indicated that the arrest for possession with intent to sell a controlled substance pertained to the valium and placidyl, and that the sale was a sale to the officer. On the other hand, that testimony is followed shortly thereafter by his testimony to the effect that no money was requested from the officer and that she was trading her drugs for heroin. Bits of heroin and cocaine were found in the residence. However, charges related to persons involved in this episode, other than the Respondent, were for possession of marijuana, from the point of view of Officer Kight's understanding of the circumstance. Respondent in her testimony indicated that she telephoned the premises where Officer Kight was involved in the investigation. In actuality, per the Respondent, two calls were made and they were in response to a telephone call that someone had made to her from the residence. On the first call she was told that the individual she was looking for was not there and on the second call she was told to come down to the premises. In that second call she talked to someone who identified himself as being Troy, the name that Officer Kight was using in his undercover capacity. Respondent was familiar with a person named Troy who frequents that residence. Respondent had been to the residence before, per her testimony. The person she was looking for at the residence was an individual identified as Dave or David. Dave or David is the son of the woman who owns the house where the suspected marijuana had been found. Respondent said that she had borrowed twenty dollars from David and that in addition David had property of hers, namely a pink opal ring. It was her intention to go to the residence and return the money she had borrowed from David and retrieve her ring. When she arrived at the scene she was approached by Officer Kight, who identified himself as Troy. According to her testimony, Kight did not get into her car. She was then invited into the house where she entered the bathroom. While in the bathroom, Kight, per her testimony, was standing in the doorway while she was using makeup and combing her hair. As she recalls, she removed her wallet and two legal prescriptions which had been filled for valium and placidyl. The prescriptions were in the name of the Respondent. Those are the items which the Respondent is accused of possessing and selling through the present Administrative Complaint. Respondent testified that the two prescriptions were still in the bag that they were placed in at the pharmacy. She further relates that those prescriptions had been filled between the first and second phone calls which she made to the residence on the night in question. According to Respondent, she placed those two prescriptions on a counter in the bathroom. Respondent states that Officer Kight then looked at those prescriptions and asked her if she wanted to get rid of them and she replied that they were hers. He asked her specifically, per her testimony, what she wanted for the valium. He then put the drugs down and asked her how much money she had, according to Respondent. Respondent states that she took her wallet out and started to count it and in turn told the officer to count it. She says that she figured he was a friend of Dave's and if he wanted to borrow a couple dollars that it would be okay. When the officer counted out seventeen dollars, she says she figured that she had left some money in the car, because she had gone to the bank, and remembered that she had more than seventeen dollars. The officer, as testified to by the Respondent, then took the two pill bottles and started to walk out of the bathroom and as she turned around to ask him where he was going with those prescriptions, she was placed under arrest. Respondent denies having any narcotics paraphernalia in her purse, such as a spoon or syringe. Likewise, she denies offering to trade or sell drugs, namely the valium and placidyl. Having considered the demeanor of the witness Night and the Respondent, and in view of the testimony given by those witnesses, the testimony of Officer Kight is not accepted. This refers to the testimony reported in this recommended order. The testimony of the Respondent is accepted, as reported in these findings of fact. Other findings of fact made in the recommended order, not attributed directly to the witnesses Kight and Mitchell are not affected by this choice.
The Issue Whether the Respondent committed the violations alleged in the Amended Administrative Complaint issued September 29, 2006, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: The Department is the state agency responsible for investigating and prosecuting complaints against persons holding licenses in the health professions and occupations, including chiropractic physicians. See § 456.073, Fla. Stat. The Board of Chiropractic Medicine ("Board") is the entity responsible for imposing penalties against chiropractic physicians for violations of Section 460.413(1), Florida Statutes. See § 460.413(2), Fla. Stat. At the times material to this proceeding, Dr. Falowski was a chiropractic physician licensed to practice chiropractic medicine in Florida, having been issued license number CH 5108. Dr. Falowski was first certified in Florida to practice chiropractic medicine in 1986. Dr. Falowski also is certified to administer propriety, or non-prescription, drugs. At the times material to this proceeding, Dr. Falowski did business as Rainbow Rehabilitation, and his address of record was 4201 North State Road 7, Lauderdale Lakes, Florida 33319. On August 17, 2003, Dr. Falowski sent to the office of John Campos, D.C., via facsimile transmittal, a document which stated FINALLY DOCTORS OF CHIROPRACTIC CAN INJECT Refresh your skills with "THE ESSENCE OF INTERVENOUS [sic]AND INJECTABLE THERAPIES" Hands-on experience covering TO INCLUDE CHELATION THERAPY OXIDATIVE THERAPY PROLOTHERAPY NEUROTHERAPY FOR THE FIRST TIME NUTRIENTS FORMULARY FOR CHIROPRACTIC (Emphasis in original.) Dr. Falowski was among the five instructors for the course listed on the document, and the cost, date, time and location of the course was also included. Finally, the document stated that the course was "Presented by the FLORIDA ASSOCIATION OF CHIROPRACTIC MEDICINE." (Emphasis in original.) On August 19, 2003, Dr. Falowski sent to the office of John Campos, D.C., via facsimile transmittal, a document in which he offered injections "available to the shoulders, elbows, knees and spine" and offered to perform all your injectable needs including Prolotherapy-neurotherapy-chelation therapy and oxidative therapy (Our office or yours) Well [sic] see your patients, treat your patients and return them to you to continue treatment in your office (Emphasis in original). Dr. Falowski included his name, identified himself as a chiropractic physician, and gave his location as Rainforest Rehabilitation, Inc., at 4201 North State Road 7, Lauderdale Lakes, Florida 33319. Chelation therapy involves the injection of a chemical into the body. Prolotherapy involves the injection of a glucose-based substance to the joints of the body. The documents sent by Dr. Falowski to Dr. Campos were sent from one chiropractic physician to another and were not disseminated to the public. The first document sent to Dr. Campos solicited his attendance at a seminar clearly intended for chiropractic physicians. The second document solicited Dr. Campos to utilize Dr. Falowski's services by referring patients to him injections and for the various therapies listed in the document.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Chiropractic Medicine enter a final order dismissing both counts of the Amended Administrative Complaint against Francis J. Falowski, D.C. DONE AND ENTERED this 20th day of March, 2008, in Tallahassee, Leon County, Florida. PATRICIA M. HART 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 20th day of March, 2008.
The Issue The issues in these cases are whether Respondent violated Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes (2002), in DOAH Case No. 09-4678PL; Subsections 456.072(1)(l), 458.331(1)(m), and 458.331(1)(t), Florida Statutes (2003), in DOAH Case No. 09-4679PL; and Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes (2005), in DOAH Case No. 09-4680PL, and, if so, what discipline should be imposed.
Findings Of Fact At all times relating to the three Administrative Complaints at issue, Dr. Kachinas was a licensed medical doctor within the State of Florida, having been issued license number ME 65595. He is board-certified by the American Board of Obstetrics and Gynecology. DOAH CASE NO. 09-4678PL In 2002, Dr. Kachinas was working at several clinics that were owned by the same individual. He received payment from Sarasota Women’s Health Center and Tampa Women’s Health Center. His primary office was located in Sarasota, but he rotated through the offices located in Clearwater and Tampa. He was advised that he would be attending a patient in the Tampa office. One of the medications that he used in his method of sedating patients, Propofol, was not available in the Tampa office. He took a vial of the Propofol and took it to the Tampa office, holding the vial in his hand. While at the Tampa office, Dr. Kachinas drew the Propofol into a syringe. He did not have to use the Propofol for the patient. He placed the syringe filled with Propofol inside the sock that he was wearing. Dr. Kachinas transported the syringe back to the Tampa office. He used this method of transport so that the office manager in the Tampa office would not know that he was transporting the drug. When he got back to the Tampa office, he placed the filled syringe in a secure place. Propofol must be used within 24 hours after being drawn into a syringe. The next day it was decided that the drug would not be used on another patient, and Dr. Kachinas wasted the syringe filled with Propofol. At the clinics where Dr. Kachinas worked, there were no logs to keep track of the drugs, except for the drug Fentanyl. Dr. Kachinas acknowledged in a letter dated January 30, 2007, to the Department of Health that his method of transporting Propofol was “unorthodox.” In the same letter, Dr. Kachinas acknowledged that “a reasonable and prudent doctor would not generally transport medication in that manner, but foolishness seemed reasonable in that aberrant environment.” DOAH CASE NO. 09-4679PL On March 26, 2004, B.S. presented to Premier Institute for Women’s Health (Premier) for an elective termination of pregnancy. Dr. Kachinas was the physician who handled the procedure. Dr. Kachinas maintained records relating to B.S. at Premier. In 2004, Petitioner subpoenaed B.S.’s records from Dr. Kachinas’ office. Petitioner received a packet of documents, which purported to be B.S.’s medical records. In July 2006, Lori Jacobs, an employee of Premier, sent Petitioner another copy of the documents sent in 2004. Neither the records provided in 2004 nor the records provided in 2006 contain progress notes for B.S.’s treatment on March 26, 2004, and March 27, 2004. For the first time on November 5, 2009, Dr. Kachinas produced a three-page document, which he claimed was part of B.S.’s medical records that had been misplaced in B.S.’s insurance file. Two of the pages purported to be progress notes for March 26 and 27, 2004. The third page, which is also labeled as a progress note, is dated June 29, 2004, and appears to relate to insurance claims. The two pages relating to March 26 and 27 are on paper which is a different color from the progress note relating to insurance claims and the progress notes which were previously furnished in 2004 and 2006.1 Additionally, the progress notes for March 26 and 27, 2004, contain a break in each of the ruled lines on the sheets on both the right and left sides of the sheets. The insurance progress note and the progress notes furnished in 2004 and 2006 do not have such breaks in the ruled lines. Dr. Kachinas completed a Laminaria Insertion report documenting procedures done on March 26, 2004, and March 27, 2004. The March 26, 2004, report documents the insertion of Laminaria and administration of medications. The comment section of the report documents the removal of the Laminaria and administration of medications on March 27, 2004. The comment section continues to document the administration of medications and the taking of vital signs after the removal of the Laminaria and also the transfer of the patient to Doctors Hospital. The detail on the comment sections suggests that Dr. Kachinas was making his progress notes in the Laminaria Insertion report. The failure to produce the purported progress notes for March 26 and 27, 2004, until November 5, 2009; the difference in the color of the paper of the March 26 and 27, 2004, purported progress notes and the other progress notes in Dr. Kachinas’ records; the presence of breaks in the ruled lines on the March 26 and 27, 2004, purported progress reports, which do not appear on the other progress notes; and the detail of the comments on the Laminaria Insertion report support the conclusion that the progress notes submitted as Respondent’s Exhibit 1 were not done contemporaneously with the treatment given to B.S. on March 26 and 27, 2004, but were prepared for this proceeding. Thus, the progress notes for March 26 and 27, 2004, are not credited. Dr. Kachinas determined B.S.’s pregnancy to be at approximately 23½-to-24 weeks’ gestation, the last week of the second trimester. He confirmed by sonogram that the gestation period was 24 weeks. On March 26, 2004, Dr. Kachinas began the induction of labor ordering the insertion of ten Laminaria, which are osomotic cervical dilators which cause the cervix to open and allow easier emptying of the uterus. Dr. Kachinas’ records do not show that B.S.’s medical history was taken prior to the insertion of the Laminaria. However, Dr. Kachinas did take a medical history of B.S. at the time of her admission to Doctors Hospital, and the history is recorded in the medical records. Prior to the insertion of the Laminaria, Dr. Kachinas’ records do show that a limited physical examination of B.S. was done. The Laminaria Insertion report shows that B.S.’s baseline blood pressure, temperature, and pulse were taken and recorded. There was no expert testimony of what other physical examination should have been done. Dr. Kachinas injected the fetus with Digoxin, which is injected directly into the fetus to stop the fetal heartbeat, causing an Intrauterine Fetal Demise (IUFD). The injection of the Digoxin was not documented in B.S.’s medical records. B.S. was then released from Premier. On March 27, 2004, B.S. returned to Premier. Prior to removing the Laminaria, Dr. Kachinas did an ultrasound and determined that there was still fetal heart activity and fetal movements. Dr. Kachinas continued the labor induction procedure by removing the Laminaria and administering Cytotec and high dosages of Pitocin. When the Laminaria were removed, there was a rupture of membranes with a loss of essentially all the amniotic fluid. Sometime during the afternoon of March 27, 2004, Dr. Kachinas did another ultrasound and determined that there was no fetal heart activity. Based on the length of time from the Digoxin injection to the ultrasound showing no fetal heart activity, the loss of amniotic fluid, and the administering of medication to cause contractions, Dr. Kachinas determined that the Digoxin injection was not the cause of death. On March 27, 2004, at approximately 6:30 p.m., Dr. Kachinas transferred B.S. to Doctors Hospital and had her admitted to the hospital for failure to progress with the induction of labor procedure. While at the hospital, B.S. continued to experience pain. On March 28, 2004, Dr. Kachinas performed the following procedures on B.S.: mini-laparotomy, hysterotomy, removal of products of conception, and a modified Pomeroy bilateral tubal ligation. In his description of the procedures, he stated that the fetal demise was at least of 48 hours duration. However, Dr. Kachinas’ records do not reflect the time of the fetal demise. Jorge Gomez, M.D., Petitioner’s expert witness, credibly testified that a physician is required to document the time of the fetal demise. In the hospital records following B.S.’s surgery, Dr. Kachinas listed the post-operative diagnosis as a failure to induce labor, an intrauterine fetal demise, a thin umbilical cord, and asymmetric intrauterine growth retardation, a condition in which the fetus is smaller than expected for the number of weeks of pregnancy. An autopsy was performed on the fetus. A surgical pathology report was also issued. The pathology report showed mild infarcts on the maternal side. On the fetal death certificate, Dr. Kachinas listed the immediate causes for the IUFD as a possible cord incident and multiple placental infarctions. Dr. Kachinas did not document the elective termination or the Digoxin injection on the fetal death certificate. Dr. Gomez disagrees with the reasons for IUFD given on the death certificate. His credible reading of the pathology report does not indicate that the infarcts were severe enough to have contributed to the fetal demise. His credible reading of the pathology report does not indicate that there was any evidence of a cord incident. Dr. Gomez is of the opinion that the cause of death should have been listed as elective termination. Dr. Gomez’ opinion is credited. However, Dr. Gomez did not give an opinion on whether the fetal demise was caused by the injection of Digoxin. DOAH CASE NO. 09-4680PL On December 13, 2005, K.M. was seen by Walter J. Morales, M.D., at Florida Perinatal Associates, which specializes in internal fetal medicine. Dr. Morales performed an ultrasound on K.M., who was pregnant with twins as a result of in vitro fertilization. The ultrasound revealed that the twins were fraternal, meaning that each twin had a separate placenta and a separate sac. One of the twins, Twin A, had an anomaly called a cystic hygroma, which results from an obstruction, causing the lymphatic fluid, which normally drains into the juglar vein, to accumulate in the neck area. Approximately 50 percent of the fetuses which have this anomaly in the first trimester also have a chromosomal anomaly, such as Down syndrome. The decision was made to have K.M. return to Florida Perinatal Associates in three weeks for further evaluation. On January 3, 2006, Edgard Ramos-Santos, M.D., a partner of Dr. Morales, performed another ultrasound on K.M. Dr. Ramos-Santos found that Twin A, a male, had a cystic hydroma, a thickening of the nuchal fold2, and shortened femur and humerus. These findings are soft markers for abnormal chromosomes. The ultrasound also revealed a possible heart defect. At the time of the ultrasound, Twin A was cephalic bottom, meaning that Twin A was positioned lowest in the uterus. Dr. Ramos-Santos also performed an amniocentesis on Twin A on the same date as the ultrasound. The amniocentesis showed that Twin A had an abnormal chromosome pattern compatible with trisomy 21 or Down syndrome. Both ultrasounds showed that Twin B, a female, appeared to be normal. At the request of K.M., no amniocentesis was performed on Twin B on January 3, 2006. At the time of the ultrasound performed on January 3, 2006, the presentation of Twin B was cephalic right. The findings of the January 3, 2006, ultrasound were discussed with K.M. and her husband. On January 9, 2006, Dr. Ramos-Santos discussed the results of the amniocentesis with K.M.’s husband. It was decided that a selective feticide would be performed on Twin A. Selective feticide is a procedure in which a solution of potassium hydroxide is injected into the fetus’ heart to make the heart stop beating. K.M. was referred to Dr. Kachinas at Premier for the selective feticide. On January 10, 2006, Roberta Bruce, a nurse at Florida Perinatal Associates, sent to Premier by facsimile transmission the January 3, 2006, ultrasound report for K.M. and K.M.’s insurance information. The cover page for the facsimile transmission included a note from Ms. Bruce, which stated: “* FYI Fetus have different gender. The male is the affected one.” The standard of care as specified in Section 766.102, Florida Statutes (2005), requires a physician performing a selective feticide to correctly identify the affected fetus. Dr. Kachinas did not correctly identify Twin A prior to performing the selective feticide and performed the procedure on Twin B, the normal fetus. Dr. Kachinas performed an ultrasound on K.M., but failed to identify the correct position of Twin A in relation to K.M. The ultrasound done on January 3, 2006, by Dr. Ramos-Santos showed that Twin A was located at the bottom and Twin B was located to the right of K.M. In his progress notes, Dr. Kachinas placed Twin A on the right and Twin B on the left. Although it is possible for twins to shift positions, it is not probable that the twins shifted from left to right. Dr. Kachinas performed an ultrasound, but failed to identify that Twin A was the fetus with multiple anomalies. Although the standard of care required Dr. Kachinas to do a Level 2 ultrasound evaluation, a Level 1 ultrasound evaluation would have identified the cystic hygroma, the shortened long bones, and the sex of Twin A. Dr. Kachinas failed to perform an adequate ultrasound evaluation by failing to identify the anomalies and the gender of Twin A. Dr. Kachinas’ notes do not show whether Twin A or Twin B had anomalies. His notes did not identify the sex of each of the twins. His notes did not document the attempts that Dr. Kachinas made to identify the anomalies such as a recording of the length of the long bones or any examination made to identify the sex of each of the twins. On January 24, 2006, K.M. returned to Florida Perinatal Associates for another consultation. Dr. Morales performed another ultrasound, which revealed that Twin A, who had the anomalies, was still viable. The ultrasound revealed the continued presence of a cystic hygroma, the thickening of the nuchal fold, shortened extremities, and a congenital heart defect. The ultrasound also showed that the viable twin was male. The presentation of Twin A was shown by the ultrasound as cephalic bottom.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED as to DOAH Case No. 09-4678PL that a final order be entered finding that Dr. Kachinas violated Subsection 458.331(1)(t), Florida Statutes (2002), by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent physician as being acceptable under similar conditions and circumstances; finding that Dr. Kachinas did not violate Subsection 458.331(1)(m), Florida Statutes (2002); imposing an administrative fine of $2,500; and placing Dr. Kachinas on probation for one year. Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED as to DOAH Case No. 09-4679PL that a final order be entered finding that Dr. Kachinas did not violate Subsections 456.072(1)(l) and 458.331(1)(t), Florida Statutes (2003); finding that Dr. Kachinas violated Subsection 458.331(1)(m), Florida Statutes (2003); imposing an administrative fine of $1,000; and placing Dr. Kachinas on probation for one year. Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED as to DOAH Case No. 09-4680PL that a final order be entered finding that Dr. Kachinas violated Subsection 458.331(1)(t), Florida Statutes (2005), by committing gross medical malpractice; finding that Dr. Kachinas violated Subsection 458.331(1)(m), Florida Statutes (2005); imposing an administrative fine of $2,000 and placing him on probation for one year for the violation of Subsection 458.331(1)(m), Florida Statutes (2005); and revoking his license for the violation of Subsection 458.331(1)(t), Florida Statutes (2005). DONE AND ENTERED this 26th day of January, 2010, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 26th day of January, 2010.
The Issue Should Respondent be disciplined for practicing beyond the scope of his license or by accepting and performing professional responsibilities which he knows or has reason to know that he is not competent to perform? See Section 460.413(1)(t), Florida Statutes, formerly Section 460.413(1)(u), Florida Statutes.
Findings Of Fact Petitioner is charged with regulating the practice of chiropractic pursuant to Sections 20.165, 20.42, Florida Statutes and Chapters 455 and 460, Florida Statutes. Respondent is a Florida licensed chiropratic physician. His license number is No. CH-0001538. He was issued that license on September 21, 1968. Respondent practices chiropratic at the McCall Chiropractic Clinic located at 811 Grace Avenue in Panama City, Florida. Respondent is not licensed as an osteopathic or allopathic physician as recognized by the Florida Board of Osteopathic Physicians or the Board of Medicine respectively. In 1992 Respondent sent Micheal Smith, D.C., a chiropractic physician practicing in Panama City, Florida, information described as an invitation for Dr. Smith to join Respondent in clinical research "designed to test the effectiveness of Scalar E.M. Technology upon AIDS-CANCER opportunistic organisms falling within the meaning of chapter 460.403(3)(a)(b)(c)(e), and Rule 21D-1702, Florida Statutes." The correspondence went on to describe some details about the research. In particular, Respondent stated that "preliminary field data suggest that Scalar E.M. TENS Technology is effective in 47 pathological conditions including AIDS-Cancer disease." The correspondence also set forth information concerning patients who wished to contribute to the research by making financial contributions to the "Allaganey Occupational Development Foundation, 22 Floor Pacific First Center, 1425th Avenue, Seattle, Washington 98101-2333". Respondent provided Dr. Smith a sheet on the McCall Chiropractic Clinic letterhead related to purported medical research at Stanford University in 1988 studying "the Biological Interactions with the Scalar Energy Cellular Mechanisms of Action" in response to weak ELF ectromagnetic (EM) radiation and the claimed results. That sheet describes how the McCall Chiropractic Clinic would be "conducting private research into the effectiveness of Scalar E.M. Technology upon the following conditions, for a two-year period of time." Arthritis Arm Pains Angina Pectoras Arethemia Asthma Allergies Bacterial Infection of the Lung Carple Tunnel Syndrome Cancer of the: Bone, Brain, Bladder, Bowell, Lungs, Liver, AIDS Colon Polyps Cholitis Candidia Albicans Deafness Diabetes Neuropathy Emphysemia Eckcemia Ear Infection Epstine Barr Infection Exothalmic Goider Feavers Fungus of the skin Fibrosis of the Lung Gout High Blood Pressure Herniated disc Herpes B infection Hemrroids Hardening of the arteries Herpes of the Genitals Hypertrophy of the Prostate Inflimation of the joints Nectniuria Kendidia Albicans Leg Pains Multipleschlerosis Musculardistrohy Neuropathy Nose bleads Premenstral Syndrome Paracititis of digestive track Phlebitis Sinus Infection Tumors of the Eye Varicose Veines Warts Leupus Erethematosis Parkinsons Disease Dr. Smith was also provided with a copy of an advertisement which stated: ATTENTION: Aids - Cancer Patients Dr. Curtis J. McCall, Jr. Chiropractor Research program utilizing scalar tens antineoplastic technology is available through the provisions of Chapter 460.403(3)(a)(b)(c)(e) Rule 21D-1702 Florida Statutes. Patients suffering with Aids - Cancer disease who would like to participate in the research program should call 769-1708 for an appointment or come by the office: 811 Grace Ave., P.C., Fla. 32401 In the 1993 yellow pages for the Panama City, Florida, telephone book, Respondent placed an advertisement to this effect: MCCALL CHIROPRACTIC CLINIC PEOPLE HAVE TRUSTED THE HANDS OF DR. McCALL SINCE 1968 -- TENS AIDS -- CANCER THERAPY -- 811 Grace Av Panama Cy 769-1708 In the July 8, 1993 advertising service in the "Thrifty Nickel" circulated in Panama City, Florida, Respondent placed the following advertisement: NOTICE: The McCall Chiropractic Clinic has on display a 1953 classified federal document that discloses successful treatment for cancer. Patient response indicates this technology is effective in the treatment of 47 conditions. This technology is available through the provisions or Chapter 460- 1403(3), (a), (b), (c), (e). Rule 210-1702 Florida Statutes. Phone 769-1708 for appointment, 811 Grace Avenue, Panama City, Florida 32401. F24 On July 19, 1993, Respondent, on stationary from McCall Chiropractic Clinic, wrote to TCRS, Inc., in Tallahassee, Florida, asking that company to place McCall Chiropractic Clinic on its list of AIDS/Cancer Therapeutic Center listings for national referrals. That correspondence gave a brief description of the service that Respondent intended to provide. It indicated that the therapy to be provided would cost the patient $18.00 per 20 minutes. Through Respondent's activities that have been described, Respondent directly held himself out to the public as having the ability to treat persons with AIDS. In furtherance of his intentions, Respondent developed a treatment protocol consisting of approximately 55 weeks of treatment to be monitored initially by Respondent at his chiropractic facility. That protocol required the patient to receive TENS therapy for two hours each day. The TENS device is designed to deliver transcutaneous electrical nerve stimulation. Its principal chiropractic use is for pain control. However, Respondent, in his intended care, contemplated that the device would stimulate "T-Cells" in combatting AIDS. In the protocol, Respondent also required monthly blood tests to monitor the patient's "T-Cell" counts. The protocol required the patient to be free from all other drugs, in particular, the AIDS treatment medication "AZT". Under the protocol, the patient was required to receive a weekly injection of a compound identified as "chondriana", in amounts determined by Respondent. Finally, the patient was to ingest a compound identified by Respondent as "life crystals". On or about February 4, 1994, Respondent began to care for the patient C.L. That care ended on September 29, 1994. In this arrangement Respondent and C.L. had a chiropractic physician-patient relationship. Patient C.L. died on August 18, 1995. Respondent made a diagnosis, proposed a course of treatment and directly treated C.L. for AIDS. In this treatment Respondent maintained a patient record for C.L. In an effort to secure reimbursement for the services provided to C.L., Respondent prepared insurance claim forms, affixing a diagnosis of AIDS to the claim forms and had C.L. assign benefits to the Respondent from the insurance policy. In this connection Respondent had C.L. execute a sworn statement describing the services received from Respondent. It was Respondent's expectation that the claim forms would be honored by the insurance carrier and that Respondent would be paid for the services rendered to C.L. With one exception, Respondent's billings to the insurance carrier for C.L.'s visits to Respondent's office were all for the treatment of AIDS. An investigation was instituted by the State of Florida, Department of Business and Professional Regulation/ Agency for Health Care Administration to ascertain whether Respondent was offering patient treatment for AIDS. James Cooksey, an investigator with the regulator, performed that investigation in conjunction with Tom Willoughby, investigator for the Bay County, Florida, Sheriff's Office. James Cooksey is an insurance fraud/medical malpractice investigator. To conduct the investigation Mr. Cooksey assumed the fictitious name James Stark. The reason for assuming the name was to present James Stark as a patient suffering from AIDS. In furtherance of the investigation Mr. Cooksey went to the Tallahassee Memorial Regional Medical Center and obtained a fictitious positive AIDS test in the name James Stark. On May 16, 1994, Mr. Cooksey initiated contact with Respondent. The investigator traveled from Tallahassee to Panama City. When he reached Panama City he called Respondent and told Respondent that he needed to come and talk to him. Respondent invited Mr. Cooksey to come by that afternoon. On May 16, 1994, Mr. Cooksey met with Respondent at Respondent's office. At that meeting Mr. Cooksey told Respondent that the investigator understood that Respondent could possibly cure AIDS. Mr. Cooksey further stated that he had seen something in a newspaper article that Respondent was treating AIDS patients and explained to Respondent that Mr. Cooksey had contracted AIDS and was interested in being cured. Mr. Cooksey provided Respondent with the results of the fictitious blood test. When Mr. Cooksey presented to Respondent he did not complain of any condition other than AIDS. Respondent did not physically examine Mr. Cooksey. Respondent explained to Mr. Cooksey about the nature of Respondent's treatment in which the TENS unit, also known as a Rife machine, chondriana and life crystals would be used. To demonstrate the treatment Respondent took Mr. Cooksey into a room in the back of his office, a treatment room, and had Mr. Cooksey take his shoes and socks off and place his feet on a metal pad associated with the TENS unit. When the unit as turned on Mr. Cooksey could feel tingling inside his feet. On this occasion Respondent told Mr. Cooksey that, he, Mr. Cooksey could get injections of chondriana and then the machine would be turned on and Cooksey would receive stimulation to fight the infection associated with AIDS. Respondent told Mr. Cooksey that the initial treatments for AIDS would have to be done at his office where Respondent would monitor the investigator. Respondent indicated that a nurse would come to the office and give the injections of chondriana and that Mr. Cooksey would be monitored concerning those injections until Mr. Cooksey's "system built up a little". Mr. Cooksey understood that he was to receive those injections and use the TENS unit and was not to take other forms of medication during the treatment. Respondent gave Mr. Cooksey a card with the name of a blood test that would need to be obtained and the results reported to Respondent. Mr. Cooksey was responsible for paying for the blood test. Respondent told Mr. Cooksey that the life crystals were to be taken in orally as a drink and they were described as being part of the AIDS treatment. On this date Respondent gave the investigator an estimate of the costs of this treatment, constituted of $2,000 for the TENS unit and $2,925 for chondriana and life crystals. Subsequent to that date Respondent called Mr. Cooksey and left a message on Cooksey's telephone. Respondent also wrote the investigator on May 23, 1994, providing the investigator more information concerning Respondent's treatment for AIDS. The investigator then went to the state attorney's office in Panama City and informed the state attorney of the nature of the administrative investigation and the belief that the activities by Respondent might constitute a criminal law violation. The state attorney represented to the investigator that he concurred. The state attorney then had Mr. Cooksey contact the Bay County Sheriff's office. Following that contact Mr. Cooksey took up a joint investigation between Mr. Cooksey and Bay County Sheriff's investigator Tom Willoughby. On October 18, 1994, Mr. Cooksey placed a call to Respondent and told the Respondent that he was in Panama City and would like to come by and meet with the Respondent and that he would be accompanied by a friend who might be able to "come up" with the money that was required to purchase the chondriana and life crystals and TENS unit. The part of the friend was to be played by Officer Willoughby. Mr. Cooksey and Officer Willoughby then went to Respondent's office where Respondent again explained the nature of the AIDS treatment. Officer Willoughby asked the Respondent questions concerning the nature of the treatment and how much the treatment would cost. Respondent explained that the treatment involved injections of the chondriana, drinking the life crystals and using the TENS machine for two hours a day to treat James Stark for AIDS. At the October 18, 1994 meeting between the investigators and Respondent, Respondent stated that a nurse practitioner with whom he was friends would administer the chondriana and that activity would be monitored by Respondent in Respondent's office. Officer Willoughby asked Respondent if there would be side affects to the injections. Respondent indicated that there would be sweating and that Respondent would monitor Mr. Cooksey for whatever period of time would be necessary for the side affects to subside. The investigators watched a video tape explaining the treatment for AIDS which Respondent intended to employ. The injections of chondriana would be given monthly. Respondent indicated to the investigators that he would instruct Mr. Cooksey on how many of the life crystals to take. Respondent told the investigators that the cost of the TENS unit was $2,000.00 and that the unit would be used to spread the impulses through out the body. Respondent indicated to the investigators that the nature of the treatment would form new T-cells to replace T-cells containing the AIDS virus or which were cancerous. Respondent had stated in Officer Willoughby's presence that the TENS unit cost $500.00 to produce. Respondent and the two investigators then went to a local health food store, known as the Olive Leaf, to ascertain the amount of money needed to pay for chondriana which the health food store would provide. There, the attendant at the store indicated that he could arrange to provide the chondriana and life crystals for a price approximating $2,800.00. After leaving the health food store the investigators told the Respondent that they would come back with the necessary money on October 21, 1994. The investigators returned to Respondent's office on October 21, 1994, after obtaining warrants to search the office and arrest the Respondent. Before Respondent was arrested and the search made, the investigators asked Respondent to again explain the nature of the treatment that would be provided to Mr. Cooksey and paid Respondent $1,700.00 for the TENS unit from funds belonging to the Bay County Sheriff's Office. Respondent gave the investigators a receipt for the $1,700.00 payment. Respondent was then arrested for practicing medicine without a license. On one occasion Respondent explained to the investigators that the procedures that were used to treat Mr. Cooksey for AIDS were not condoned by the FDA, but that it was working in other places where it had been tried and that three patients treated in another location had gained remission from the AIDS. Based on the proof, it is found that Respondent diagnosed Mr. Cooksey as having AIDS and developed a course of treatment for that condition. Paul Doering, M.S., is a registered pharmacist in the State of Florida. He is also licensed as a consultant pharmacist in the State of Florida. He is a Distinguished Service Professor of Pharmacy Practice at the University of Florida. He is accepted as an expert pharmacist. Mr. Doering established that the drug AZT is an antiviral drug designed to address the HIV virus associated with AIDS. Mr. Doering established that AIDS is an acronym for acquired immuno- deficiency syndrome, "a disease that affects the immune system caused by a virus or different types of viruses which attack the immune system in the body rendering the body unable to effectively mount an immune response when it comes into contact with certain types of infectious organisms." Mr. Doering established that drugs are divided into two basic groups, one group which is sold without prescription and the other group requiring a doctor's prescription. The latter category of drugs are known as Federal Legend Drugs. Mr. Doering established that there is no reference to a medication known as "chondriana" in any directory of medications which he was familiar with. As he established, chondriana does not constitute a food because foods are not generally injected into the human body. Mr. Doering established that chondriana has not been approved to be used as a drug in the United States, nor is it an experimental drug, based upon his research of sources that list drugs or experimental drugs. Marianne Gengenbach, D.C., is licensed to practice chiropractic in Florida and is an expert in chiropractic practice. She established that chiropractors are limited to using proprietary drugs, and then only where the chiropractor has passed a specific exam and obtains a proprietary drug license. Proprietary drugs are "over the counter drugs" not prescription drugs. Absent such as a license to prescribe proprietary drugs chiropractors may only make recommendations, educate patients and prescribe nutritional supplements. Dr. Gengenbach established that Respondent had diagnosed C.L. for AIDS and had treated C.L. for that condition. The treatment was directly related to the condition AIDS, and Dr. Gengenbach established that the treatment was outside the accepted standard of care for chiropractic and exceeded the scope of authorized practice from the view point of a practitioner. As Dr. Gengenbach established, Respondent also exceeded the proper scope of practice in caring for C.L. by recommending that C.L. discontinue the AZT therapy. Those same perceptions were held for treatment of Mr. Cooksey and are accepted. Dr. Gengenbach established that Respondent proposed a course of treatment for Mr. Cooksey related to the condition AIDS, without reference to any other complaints by the patient. As a consequence the course of treatment which Respondent planned for Mr. Cooksey was directed solely to the HIV infection as established by Dr. Gengenbach. Dr. Gengenbach established that the use of the chondriana and life crystals was intended to treat Mr. Cooksey for AIDS. Dr. Gengenbach established that even should the substances chondriana and life crystals be considered food or nutritional supplements, there proposed use for Mr. Cooksey would not meet the prevailing standard of care for chiropractic, in that they would be employed for the treatment of AIDS. Respondent intended that the chondriana and life crystals be used in the cure, treatment, therapy and prevention of AIDS in C.L. and Mr. Cooksey. Respondent intended that those substances affect the structure and function of the bodies of those patients. In proposing and carrying out the treatment that has been described directed to AIDS, Respondent did so mindful that chiropractic physicians in Florida are prohibited from directly treating the AIDS condition. Respondent's treatment of C.L. and proposed treatment of Mr. Cooksey violated the standards of practice acceptable to a reasonably prudent chiropractic physician under similar conditions and circumstances and exceeded the scope of his chiropractic license. In the past Respondent has been disciplined by the Board of Chiropractic on three separate occasions. Two of those cases involve the receipt of a reprimand and in the third case Respondent's license was suspended and he was required to pay an administrative fine. Respondent was also required to cease and desist the activities described in these facts based upon action taken by the Board of Medicine, which was persuaded that Respondent was engaging in the treatment of AIDS without benefit of a medical license.
Recommendation Based upon the facts found and the conclusions of law reached, given the severity of the offense and the danger posed to the public, it is, RECOMMENDED: That a final order be entered which revokes Respondent's license to practice chiropractic medicine in Florida. DONE and ENTERED this 21st day of November, 1995, in Tallahassee, Florida. CHARLES C. ADAMS, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 21st day of November, 1995. APPENDIX CASE NO. 95-2881 The following discussion is given concerning the proposed findings of fact of the parties: Petitioner's Facts: Paragraphs 1 through 4 are subordinate to facts found. Paragraphs 5 and 6 constitute conclusions of law. Paragraphs 7 through 13 are subordinate to facts found. Paragraph 14 is not necessary to the resolution of the dispute. Paragraphs 15 through 35 are subordinate to facts found. Paragraphs 36 through 40 are conclusions of law. Paragraph 41 is subordinate to facts found. Paragraphs 42 and 43 are conclusions of law. Paragraphs 44 through 51 are subordinate to facts found. Respondent's Facts: Paragraphs 1 through 5 constitute legal argument as reported at pages 2 through 5. The proposed facts 1-3 found at pages 15 and 16, Paragraph 1 is contrary to facts found. Paragraph 2 is rejected as a discussion of activities of the Probable Cause Panel, not a proper subject for consideration. Paragraph 3 constitutes a conclusion of law. COPIES FURNISHED: Jon M. Pellett, Esquire Medical Quality Assurance-Allied Health Agency For Health Care Administration 1940 North Monroe Street, Suite 60 Tallahassee, FL 32399-0792 Curtis J. McCall, D.C. 514 North Bonita Avenue Panama City, FL 32401 Diane Orcutt, Executive Director Agency For Health Care Administration Board of Chiropractors 1940 North Monroe Street Tallahassee, FL 32399-0792 Jerome W. Hoffman, General Counsel Agency For Health Care Administration 2727 Mahan Drive Tallahassee, FL 32308
The Issue The issues are whether Respondent obtained Oxycontin by using a forged prescription, in violation of Section 464.018(1)(h), Florida Statutes, and Rule 64B9-8.005, Florida Administrative Code, which prohibit unprofessional conduct, and in violation of Section 464.018(1)(i), Florida Statutes, which prohibit the unauthorized possession, sale, or distribution of controlled substances; and whether Respondent's use of Oxycontin affects her ability to practice nursing with reasonable skill and safety, in violation of Section 464.018(1)(j), Florida Statutes, which prohibits the inability to practice nursing with reasonable skill and safety by reason of illness or use of alcohol, drugs, narcotics, or chemicals or as a result of any mental or physical condition. If so, an additional issue is what penalty should be imposed.
Findings Of Fact Respondent is a licensed registered nurse, holding license number RN 521142. She has been so licensed for 31 years. Respondent's long career in nursing has featured dedication, hard work, commitment, and competence. The record does not reveal any past discipline. For most of Respondent's professional career, starting in 1971, she has worked at Indian River Memorial Hospital in Vero Beach. Respondent has worked in various capacities at the hospital, including the emergency room and operating room. Respondent later helped develop a neurological unit at the hospital. Starting in 1980, she worked for a couple of years at Vero Orthopedics. Since 1997, Respondent has worked on a contract basis at the Indian River Memorial Hospital, although her present physical infirmities, partly described below, prevent her from working at present. In May 2000, Respondent injured her back while moving a heavy patient in the hospital. A couple of months later, Respondent underwent a laminectomy to relieve the pain from two herniated disks. Six weeks after the surgery, Respondent reinjured her back and had to undergo additional surgery. Six weeks after the second surgery, Respondent, who was not doing well, left her job at the orthopedic clinic and took a less strenuous job. One month after doing so, Respondent was still experiencing pain when she got into and out of cars. In June 2001, Respondent underwent a third operation, in which the surgeon fused two injured vertebrae. The surgery obtained access to the vertebrae by a posterior incision running from the breast to the pubis. The surgery also required a hip bone graft, thus necessitating an incision to the hip. The recovery from this excruciatingly painful surgery was difficult, and Respondent has not yet returned to work, although she is nearing the point at which she can perform some nursing-related work, such as teaching. At present, she still has difficulty walking or standing. When discharging Respondent from the hospital in late June 2001, Dr. Gomez prescribed her Oxycontin for pain. Dr. Gomez was covering for Respondent's neurosurgeon, Dr. Magana. Later, Dr. Cunningham, a pain management specialist and Respondent's family physician, resumed the care of Respondent. Dr. Cunningham continues to monitor Respondent and treat her pain. On direct examination, Respondent testified that she has not taken Oxycontin since December 2001. (However, on August 9, 2002, Respondent told her certified addictions professional that she had not taken any Oxycontin since March 2001.) Respondent testified that, after Oxycontin, she took no pain medication besides nonsteroidal anti-inflammatory medications and steroids. However, on cross-examination, Respondent admitted that she takes Methadose as needed, pursuant to a prescription from Dr. Cunningham. Respondent testified that he switched her from Oxycontin in July 2002. Respondent filled the Methadose prescription at a different drug store than the one that she has used for her other prescriptions. On October 5, 2001, Respondent presented a forged prescription to a different drug store than the one she has used for her other prescriptions. The prescription was for fifty 20- mg. Oxycontin tablets, which Respondent picked up two days later. Respondent fraudulently obtained the Oxycontin for her own use. Oxycontin is an analgesic opioid and a schedule II controlled substance. It is highly addictive and presently among the most commonly abused controlled substances. Oxycontin can produce a feeling of short-lived euphoria, as well as impaired cognitive functioning and impaired judgment. Methadose, a form of methadone, is a synthetic analgesic. It is also used in the detoxification process undergone by heroin addicts. Petitioner has proved by clear and convincing evidence that Respondent engaged in unprofessional conduct in her acquisition of the Oxycontin by using a forged prescription and that Respondent unlawfully possessed a controlled substance. Petitioner has not proved by clear and convincing evidence that Respondent's use of Oxycontin affects her ability to practice nursing with reasonable skill and safety. First, Petitioner did not prove by clear and convincing evidence that Respondent still uses Oxycontin. It appears likely that she may have substituted Methadose for Oxycontin to manage her pain. It is unclear from the present record whether Respondent's use of Methadose is also to assist her in overcoming an addiction to Oxycontin. But even if Petitioner had pleaded Methadose rather than Oxycontin, the record does not reveal the extent to which Respondent presently uses Methadose. For the reasons stated in the preceding paragraph, the relevance of the Methadose is not to prove the third count of the Administrative Complaint, but to underscore the risk that Respondent may pose if she practices nursing at present. Respondent was not candid at the hearing. She was not candid about the October 2001 incident. She was not candid about the recent use of Methadose and was evasive about the drug's properties. The two-hour evaluation that Respondent underwent by a certified addictions professional was cursory and curiously deferential to Respondent. This remarkable evaluation is entitled to absolutely no weight whatsoever. The opinion of the certified addictions professional that Respondent does not suffer from a drug abuse or dependency may or may not be true, but, if true, the result is a chance occurrence, rather than a professional conclusion following the comprehensive collection of relevant, reliable data and the careful, informed analysis of such data. The safeguards provided by the pretrial intervention program, into which Respondent entered after her arrest for the fraudulent acquisition of the Oxycontin, are inadequate. The random drug tests always occur on Tuesdays, just not every Tuesday. The assurances that ensue from Respondent's apparent compliance with the conditions of her probation, which include negative urinalyses, are meaningful, but not sufficiently rigorous to provide the necessary protection to a nurse's patients. On December 26, 2001, Petitioner entered an emergency suspension order in this case. The record amply demonstrates that Respondent will suffer considerable financial distress if denied the opportunity to practice her profession. However, Respondent's lack of candor precludes a detailed analysis of the safeguards in her current monitoring program and a detailed prescription of what, if any, additional safeguards would be required to permit any discipline short of a suspension. In its proposed recommended order, Petitioner seeks a suspension until lifted pursuant to, and subject to the conditions set by, an evaluation coordinated by the Intervention Project for Nurses (IPN); treatment as recommended by the IPN; probation for three years if no treatment is recommended by the IPN; an administrative fine of $750; a reprimand; and the assessment of costs of the investigation and prosecution.
Recommendation It is RECOMMENDED that the Board of Nursing enter a final order finding Respondent guilty of violating Section 464.018(1)(i), Florida Statutes, and imposing a penalty of a $250 administrative fine, a suspension until lifted pursuant to, and subject to the conditions set by, an evaluation coordinated by the IPN; treatment as recommended by the Intervention Project for Nurses; probation for three years if no treatment is recommended by the Intervention Project for Nurses; and the assessment of costs of the investigation and prosecution, upon remand, if necessary. DONE AND ENTERED this 20th day of December, 2002, 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 20th day of December, 2002. COPIES FURNISHED: Dan Coble, RN PhD CNAA C, BC Executive Director Board of Nursing Department of Health 4052 Bald Cypress Way, Bin C02 Tallahassee, Florida 32399-3252 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Amy M. Pietrodangelo Assistant General Counsel Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Suzanne H. Suarez Suzanne Hope Suarez, P.A. The Legal Building 447 3rd Avenue North, Suite 404 St. Petersburg, Florida 33701-3255
