The Issue The issue in this case is whether Respondent, Shelly O. Wolland, D.O., committed the violations alleged in an Administrative Complaint dated April 12, 2002, issued by Petitioner, the Department of Health, in DOH Case No. 2001- 16871, and, if so, what disciplinary action should be taken against her.
Findings Of Fact The Parties. Petitioner, the Department of Health (hereinafter referred to as the "Department"), is the agency of the State of Florida charged with the responsibility for the investigation and prosecution of complaints involving physicians licensed to practice osteopathic medicine in Florida. Respondent, Shelly O. Wolland, D.O., is, and was at the times material to this matter, an osteopathic physician licensed to practice osteopathic medicine in Florida, having been issued, on September 30, 1987, license number OS 5378. On November 29, 2001, and at all times relevant to this proceeding, Dr. Wolland worked as an osteopathic physician at Sunshine Medical, Inc. (hereinafter referred to as "Sunshine"), located at 1498 Northwest 54th Street, Miami, Florida 33142. Dr. Wolland's Practice. For approximately ten years prior to 2001, Dr. Wolland had worked as a physician at Florida Park Health Center, the predecessor of Sunshine. She purchased the assets of Florida Park Health Center in January 2001. Dr. Wolland's practice at the times relevant consisted of "an intercity family practice with a very large pediatric practice, also a very large HIV, AIDS practice." Transcript, page 604, lines 20-23. Dr. Wolland was involved in the treatment of "over 200 AIDS patients," who "came in once a week to once a month." Id. Dr. Wolland dealt primarily with the adult patients who presented to Sunshine, including those with HIV and AIDS, while her brother, Steve Ozapoff, a physician's assistant, was responsible for the initial treatment of pediatric patients. Dr. Wolland employed a staff of between nine and 12 employees. C Operation Clean Clinic. During the Fall of 2001, the Medicaid Fraud Control Unit, Office of the Attorney General (hereinafter referred to as the "MFCU"), was engaged in an investigative operation dubbed "Operation Clean Clinic." The "mission" of Operation Clean Clinic was to inspect medical clinics or offices involved in the provision of Medicaid services in Florida to ensure that each clinic or office inspected and all personnel employed by an inspected clinic or office were properly licensed, and that Medicaid recipients and others were being provided quality care by the inspected clinic or facility. Operation Clean Clinic inspections were performed by "teams," made up of a commander and several investigators, all of whom had specific assigned tasks to carry out during an inspection. The Miami Bureau of the MFCU performed its first Operation Clean Clinic inspection in November 2001. That inspection was performed at Sunshine on November 29, 2001. The November 29, 2001, Inspection Team. The inspection team that conducted the Operation Clean Clinic inspection of Sunshine on November 29, 2001, was commanded by Lieutenant Tom Vicente. Because this was the first inspection conducted by the Miami Bureau MFCU, Lieutenant Luis Albuerne assisted. While Lieutenant Albuerne testified, Lieutenant Vicente did not. The inspection team that day also included the following Investigators:6 Sandra Lozowicki; John D. Eller; Raymond Alamo; Richard Baudin; and David B. Schue. With the exception of Investigator Baudin, all testified at the final hearing. The duties of the Investigators included the following: Inspector Lozowicki was the Senior Investigator. She was responsible for coordinating and supervising the efforts of the other investigators. Inspector Lozowicki ultimately assisted in the inventorying of medications found at Sunshine and in questioning and obtaining a statement from Dr. Wolland; Inspector Eller was assigned the responsibility of assisting in making copies of documents and assisting Investigator Schue. Ultimately he also assisted in the inventorying of medications found at Sunshine; Inspector Alamo was assigned the responsibility for taking photographs; and Inspector Schue was responsible for making a to-scale drawing of Sunshine's offices. His drawing and a blow-up thereof, were accepted as Petitioner's Exhibits 1 and 1A. (All references to rooms in this Recommended Order will be to the names used by Inspector Schue on those exhibits to identify rooms).7 Inspector Baudin did not testify and, therefore, his overall duties were not described. He did, however, participate in questioning Dr. Wolland. The General Conduct of the Inspection. The Operation Clean Clinic inspection of Sunshine was initiated between 10:00 to 10:30 a.m., November 29, 2001. Lieutenants Vicente and Albuerne entered the facility, leaving the rest of the inspection team outside. They introduced themselves to Dr. Wolland and explained the purpose of their inspection. Dr. Wolland, who had been informed by letter from the MFCU that an inspection would be made at some unspecified time in the future,8 was cooperative and provided all assistance requested by the inspection team. Lieutenant Albuerne described his initial conduct upon entering Sunshine, in part, as follows: . . . . Like I said, when I first went in, the first thing I did is, I spoke with Dr. Wolland. Q. Right. And then after you did that, did you call the other investigators in right away, or had you looked over the premises before --- A. No. When I first met with Dr. Wolland, it took a little while, because I wanted to make sure that she understood what I needed and the personnel that I was going to need from her, in order to facilitate getting their records that we were going to need. Once that was accomplished, you know, and she told me that she would provide somebody, that's then when I brought the team in. Transcript, page 44, lines 11-22. After meeting with Dr. Wolland, which "took a little while" according to Lieutenant Albuerne, the rest of the team was brought into the facility. According to the Investigative Note written by Inspector Lozowicki on or about December 17, 2001, "Lieutenants Thomas Vicente and Luis Albuerne identified themselves and about 30 minutes later, the team entered the premises." Upon entering the premises, in addition to the members of the team independently making their way throughout the facility to carryout their assigned duties, Lieutenant Albuerne, as he described it, made an initial "cursory walk- through of the facility." During his walk-through, Lieutenant Albuerne observed a refrigerator located in the Medication Storage Laboratory which contained plastic trays in which unlabeled syringes filled with a clear liquid were stored. He also observed numerous other medications in the Medication Storage Laboratory and the Infusion Preparation Room, including a number of expired medications and medications which had been dispensed to particular patients. Lieutenant Albuerne saw enough of what he believed were improperly labeled and/or stored medications to cause him to decide that the Department's Bureau of Pharmacy Services should be contacted. Lieutenant Albuerne explained his reason for contacting the Department: I wanted to make sure that if those products were going to be dispensed, that they were, you know, properly labeled, and that they were, you know, in such a state that they could be used by, or be given to an individual or person. Transcript, page 49, lines 13-17. What Lieutenant Vicente did between the initial meeting with Dr. Wolland and when the rest of the inspection team came into Sunshine to carry out their assigned duties, was not accounted for during the hearing of this matter. Inspector Lozowicki described her initial actions upon being called into Sunshine by the Lieutenants, in part, as follows: I believe we met with Dr. Wolland and then met with some of the staff to provide them the list of the Medicaid recipients whose files we needed pulled so we could start copying. Q. At what point did you walk around the medical facility? A. It might have been shortly after that. Subsequently, Inspector Lozowicki was informed "either by one of the lieutenants or one of the investigators" that there was a room full of medication bottles. That room was the Infusion Preparation Room. Obviously, Inspector Lozowicki was not the first member of the inspection team to enter the Infusion Preparation Room and, consequently could not clearly and convincingly describe the unspoiled state of the medications stored there: Q. Was there anybody else in this are you identified, the infusion preparation room, with all the medications out? Was there anybody else in that room when you walked by it? A. I can't remember. I think so. I know I wasn't the first one to see it. Transcript, page 177, lines 8-14. The Department has suggested that it was only about ten minutes after entering Sunshine that Inspector Lozowicki entered the Infusion Preparation Room. Even if this estimate of time were accurate, which it is not, that means Inspector Lozowicki did not enter the Infusion Preparation Room until a minimum of 40 minutes after the two Lieutenants first entered Sunshine. Eventually, Inspector Lozowicki spent the rest of the day assisting in an inventory conducted by the Department's Bureau of Pharmacy Services of medications found in the Infusion Preparation Room and participated in questioning and obtaining a statement from Dr. Wolland Inspector Eller, shortly after entering Sunshine, was directed by one of the Lieutenants to wait at the front of the facility for the arrival of someone from the Department's Bureau of Pharmacy Services. That individual, pharmacist Mary Ghabrial, arrived at Sunshine at approximately 11:00 a.m. After escorting Ms. Ghabrial into the facility, Inspector Eller then observed the Infusion Preparation Room and the Medication Storage Laboratory. Obviously, he was not the first one to enter these rooms. At least 30 minutes to an hour passed before Inspector Eller saw either room. Inspector Eller spent the majority of the day assisting Ms. Ghabrial in inventorying medications found in the Infusion Preparation Room and the Medication Storage Laboratory. Inspector Schue, who was responsible for measuring the facilities rooms, was primarily occupied with his responsibilities. Finally, Inspector Alamo took photographs within the facility. He arrived in the Infusion Inspection Room and the Medication Storage Laboratory after other members of the inspection team. In fact, the inventory described, infra, had already commenced when he began taking the photographs accepted into evidence as Petitioner's Exhibits 2 and 3. The Department's Inventory. After arriving at Sunshine and being shown the medications that had been found in the Infusion Preparation Room and the Medication Storage Laboratory, Ms. Ghabrial, assisted by Inspectors Lozowicki and Eller, inventoried all of the medications found in both rooms. The medications inventoried included unlabeled pre- filled syringes which contained a clear liquid. The content of those syringes was ultimately identified by Dr. Wolland during the inspection and, but for the contents of 200 syringes allegedly filled with Serostim, at hearing. Also inventoried were medications described by Ms. Ghabrial as follows: . . . . There were medications that had prescriptions -- I mean that had labels from pharmacies, dispensing pharmacies to patients, to specific patients, and there were others in amber vials that had not labels, as well as there were two bags, as I recall, two red bags, the bags said Procrit on it [sic], and they had -- they were filled with syringes with clear liquid. . . . Transcript, page 352, line 25, and page 353, lines 1-9. Ms. Ghabrial further described the "amber vials": They're amber vials, usually used by pharmacies to dispense medication in them, but they had no labels, and they just had some pills that we couldn't identify, and some had like a handwritten white paper that said, that had the name of the drug on it, and the dosage, but no expiration date, no lot number, nothing else to identify it. Transcript, page 354, lines 9-15. The medications that appeared to have been dispensed by a pharmacy to a particular patient, included pharmacies, in addition to a pharmacy located in the same building as Sunshine, located in: Tampa, Florida; Chicago, Illinois; and Broward County, Florida. There was one that had been dispensed by the Miami-Dade County Health Department. Many of the medications inventoried were expired medications. The inventories completed by Ms. Ghabrial, Inspector Lozowicki, and Inspector Eller were properly identified and admitted into evidence as Petitioner's Exhibits 4 and 8. Other than the inventory taken by Inspector Lozowicki, who only took inventory in the Infusion Preparation Room, which room and the location within a room the medications listed on the inventories were actually found was neither identified on the inventories nor through testimony or other evidence. As to Inspector Lozowicki's inventory, the evidence only proved the room in which the medications were found, but not their location within the room. Dr. Wolland's Statement. Late in the afternoon or early evening of November 29, 2001, Dr. Wolland was questioned by Inspectors Baudin and Lozowicki. She answered questions posed to her freely, without any coercion, threat, or promise. She also gave a written statement, which she wrote herself after being administered an oath. Again, she gave this statement freely, without any coercion, threat, or promise. While Dr. Wolland was asked to address certain issues in her written statement and the exact number of pre-filled syringes found by investigators, she was not told specifically what to write about those issues. For example, she was asked to explain why she had pre-filled syringes found in the Infusion Preparation Room and the Medication Storage Laboratory. She was also asked to explain why she had medications which had been dispensed to patients from various sources. The Department's Failure to Prove Precisely Where Many Medications Were Stored. There were two rooms at Sunshine where pharmaceuticals were found to be stored: the Infusion Preparation Room and the Medication Storage Laboratory. Other than boxes of Novolin, which is insulin, and the pre-filled syringes found at Sunshine, both of which are discussed, infra, the Department failed to prove precisely where "adulterated and expired" medications inventoried by the Department were located before the arrival of the inspection team (hereinafter, all medications found at Sunshine other than Novolin and the pre-filled syringes will be referred to as "Adulterated and Expired Drugs"). The precise location of the Adulterated and Expired Medications is crucial because some of the charges of the Administrative Complaint are based upon allegations of improper medication storage techniques utilized at Sunshine by Dr. Wolland. As to most of the medications found in the Infusion Preparation Room and in the Medication Storage Laboratory, their precise location was not proved clearly and convincingly and, therefore, the Department has failed to prove clearly and convincingly that the Adulterated and Expired Medications were improperly stored. First, and most importantly, the Department has not proved clearly and convincingly that Adulterated and Expired Medications found in the Infusion Preparation Room were simply improperly stored as opposed to being retained for destruction. Dr. Wolland testified convincingly and credibly that, due to the condition of many of her patients, she often took medications from patients which had expired or for whatever reason, were no longer being taken by the patient, in order to prevent confusion as to what medications the patient should be taking and to prevent their use by others.9 Dr. Wolland described at hearing why she accepted unused bottles of medications from her patients: I'm talking about AIDS patients, with full-blown AIDS, who are on maybe three, four, five anti-viral medications, plus meds for yeast, plus meds for toxins in the brain, plus meds for asthma, plus meds for blood pressure, plus meds to build their blood, plus there could be medication for their liver problems, and medication because of -- to prevent PFP, pneumonia, and they get hospitalized, and with the 12 bottles that they already have, there is [sic] now 20 bottles, and they don't know what is what. They come in and say, Doc, I've got all these new meds, I don't know what they're for. They bring me their medications. I say, yes, yes, take this, take this, this is for your flush, this for your AIDS, this is for your AIDS, this is for your AIDS. I write on there, this for your heart, this is for -- you don't need this one, this one is making you sick, this one is contraindicated with that one. I do take them, I put them in a cabinet, lock them up, because if they took all of them together it cold kill them. And there is [sic] way too many bottles for me to say to them, dump that one in the garbage. They can't tell, don't know Asythromane (Phonetic) from Clarthomane (Phonectic) from Calextra (Phonetic) from Averiad (Phonetic), et cetera. Transcript, page 630, lines 22-25, and page 631, lines 1-20. In her sworn written statement of November 29, 2001, Dr. Wolland gave the same reason for having such medications: The AIDS patients have frequent oral medication changes, and are on multiple medications when I change a patients [sic] meds. I ask them to return to me their remaining unused bottles so they do not get confused and take the wrong meds when [they] have so many bottles. That is why I have a cabinet full of unused bottles so they do not get confused and take the wrong meds when [they] have so many bottle. That is why I have a cabinet full of expired, opened meds with patients names on most of them. . . . While Dr. Wolland readily admitted accepting and storing medications given to her from her patients, she also testified that she maintained those medications in a separate area of the cabinets located in the Infusion Preparation Room and that those medications were properly identified as being held for destruction and kept locked. While her testimony in this regard is not credited totally,10 her testimony as to keeping the medications in locked cabinets is.11 Dr. Wolland's testimony that the cabinets and the refrigerator in the Infusion Preparation Room were locked was consistent and convincing. That testimony was also supported by Petitioner's Exhibit 3k, in which the latches for the locks on the cabinet doors can be seen; Petitioner's Exhibit 3m and 3ii, in which the latch for the refrigerator is visible; and Petitioner's Exhibit 3ii in which the latch and the opened lock can be seen on top of the refrigerator. Even if Dr. Wolland's testimony was not credited as to the locked cabinets and the locked refrigerator located in the Infusion Preparation Room, it was the Department's burden to prove clearly and convincingly that they were not locked. This the Department failed to do, for no member of the inspection team who entered the Infusion Preparation Room was able to testify that there were no locks.12 In fact, all of the members of the inspection team who testified were unable to recall whether there were locks. More importantly, the question of whether any medications were being held for destruction and were properly stored, was not one that Dr. Wolland was required to answer. It was not her burden to prove that any medications were properly stored for destruction; it was the Department's burden to prove clearly and convincingly that they were not. Testimony to the effect that "I don't recall seeing any medications identified as being held for destruction" does not meet that burden. Given the fact that the evidence proved that Dr. Wolland had a legitimate reason for accepting medications from her patients which they no longer needed and the fact that she maintained them in a locked cabinet, even though Dr. Wolland's testimony as to where precisely those medications were maintained by her was not convincing, the Department had the burden of proving that the Adulterated and Expired Medications it discovered in the Infusion Preparation Room were not those which were being held by Dr. Wolland for destruction. This the Department did not do. Turning to the Medication Storage Laboratory, given the fact that it has not been proved that there were no improperly stored medications in the Infusion Preparation Room, the Department needed to prove in particular which Adulterated and Expired Medications were found in the Medication Storage Laboratory, where there was no suggestion that drugs were being held for destruction. This the Department failed to do: the inventory accepted in evidence in this case and the testimony concerning that inventory did not establish what Adulterated and Expired Medications were found there as opposed to the Infusion Preparation Room. Ms. Ghabrial and Investigator Eller, the two individuals who conducted the inventory of the medications found in the Medication Storage Laboratory, were also involved in the inventory of the Infusion Preparation Room. While they both indicated that they found Adulterated and Expired Medications and identified the pages of the inventory they completed which listed those medications, they failed to indicate which of those pages relate to which room. There general testimony about what they witnessed at Sunshine also did not explain what Adulterated and Expired Medications were found in which rooms. Therefore, given the fact that, by failing to distinguish between Adulterated and Expired Medications stored in the Medication Storage Laboratory and the Infusion Preparation Room, the Department has failed to prove clearly and convincingly what medications were not being properly stored for destruction. The failure of the Department to meet its burden of proof stems from the fact that it failed to present testimony from the first member of the inspection team to have entered the Infusion Preparation Room and, more importantly, testimony as to the very first person to look into the locked cabinets of the Infusion Preparation Room. That person was in all likelihood, Lieutenant Vicente. According to Dr. Wolland's unrebutted and credited testimony, Lieutenant Vicente went through the clinic with her and requested that she unlock cabinets and the refrigerator located in the Infusion Preparation Room. This testimony has been credited. Having likely been the individual who first witnessed what was in the cabinets in the Infusion Preparation Room, Lieutenant Vicente was the only person who could precisely describe where medications were stored in those cabinets immediately before the inspection began. Every member of the inspection team who did testify, entered that room after others had been in there. They were not able, therefore, to testify clearly and convincingly that nothing they saw had been moved, rearranged, or otherwise modified. It is not even clear who entered the room second or, more importantly, what had transpired in the room before they did. The photographs taken by Inspector Alamo on November 29, 2001, also do little to establish the state in which the Adulterated and Expired Medications were stored. Only a few of those photographs have been clearly and convincingly shown to depict Adulterated and Expired Medications before they were moved from their original location, i.e., Petitioner's Exhibit 3d. The rest, while depicting medications found in the facility, do not depict the original state they were found in, as Inspector Alamo admitted: Q. Okay. Well, do you remember the time you were in the clinic taking photographs? A. No, sir. Q. Approximately? A. No, sir, I don't remember. Q. Was it early morning until at night? A. I don't recall the time. . . . . Q. Did you assemble and pose these containers, or whatever they are, before you took pictures? A. On some of the pictures, not all of them. Q. Who posed the products on the other pictures? A. It may have been myself or other members on our team. Q. Okay. And did you take those things out of the locked cabinets, or did somebody else do that? A. I don't recall. Transcript, page 91, lines 22-25; page 92, lines 1-25; and page 93, line 1. Even a cursory examination of the photographs shows why they are not helpful in solving this issue. The following are only a few examples: Petitioner's Exhibit 3a shows syringes which had been taken out of the refrigerator; Petitioner's Exhibit 3b and 3c show a tray of syringes with a hand pulling it out. These photos also show that medications which were located on the top shelf of the refrigerator as evidenced by Petitioner's Exhibit 3d have been removed; Petitioner's Exhibits 3e and 3v depict syringes which had been removed from the refrigerator; Petitioner's Exhibit 3f depicts insulin which Ms. Ghrabrial testified was found in a refrigerator; Petitioner's Exhibit 3m depicts medications on top of the refrigerator located in the Infusion Preparation Room which are not depicted in Petitioner's Exhibit 3ii; and Petitioner's Exhibit 3y depicts two plastic baskets of syringes on a shelf which in Petitioner's Exhibit 3z and 3aa are located on a counter top. In summary, the Department has failed to prove clearly and convincingly that Adulterated and Expired Medications found and inventoried in the Infusion Preparation Room and the Medication Storage Laboratory on November 29, 2001, were not being held for destruction. The Infusion Preparation Room. Medications found in the Infusion Preparation Room which the Department proved were not being held for destruction included, in relevant part, the following: Approximately 20 unmarked pre-filled syringes containing Procrit stored in a plastic tray, approximately eight inches long, four inches wide, and two-thirds-inch high. Procrit was, and still is, designated as a legend drug in Section 456.003(7), Florida Statutes (2001). Procrit is indicated for very severe anemia, end-stage AIDS, hemorrhage, liver disease, or anti-viral medications that cause destruction of blood cells. Procrit needs to be stored refrigerated. According to the manufacture's specifications, Procrit should be administered as soon as possible after it is drawn up to avoid issues of contamination. If properly stored, pre-filled syringes can be stored for up to two weeks; Approximately the same number of unmarked pre-filled syringes containing Neupogen stored in another plastic tray identical to one in which the Procrit was found. Neupogen was, and still is, designated as a legend drug in Section 456.003(7), Florida Statutes (2001). Neupogen is indicated for patients undergoing chemotherapy or AIDS patients that have depressed immune systems. Neupogen needs to be stored refrigerated; Two paper shopping-type bags labeled "Procrit" were stored on a shelf in the upper right cabinet in the room. These bags contained 200, unmarked pre-filled syringes. The syringes were filled with Serostim. Serostim was, and still is, designated as a legend drug in Section 456.003(7), Florida Statutes (2001). It is indicated for the treatment of AIDS wasting. In order to use it, it must be mixed with a dilutant and it should be stored in a refrigerator. Before dilution, Serostim may be stored at room temperature. Once diluted it should be used immediately; and Novolin (insulin), stored in the manufacturer's box in the refrigerator. There was no lot number, expiration date, or other identifying information on or with any of the pre-filled syringes found in the Infusion Preparation Room. The only identifying information concerning the pre-filled syringes consisted the name of the drug written on a piece of paper taped to the two trays in which the Procrit and Neupogen were stored. The pre-filled syringes of Serostim were not labeled in any way and, in fact, were stored in a bag with "Procrit" printed on it. Dr. Wolland identified the pre-filled syringes of Procrit, Neupogen, and Serostim in her sworn written statement on November 29, 2001, and indicated that she pre-filled syringes with Procrit, Neupogen, and Serostim: To prevent patients from selling injectable meds that they need, in particular, Serostim, Procrit, Neupogen, Decadurbolin, Depotestostorone & Rocaphin, I keep the injectables locked up in my cabinets and administer them to the patients as ordered, usually in pre-drawn syringes to prevent theft and resale. . . . I predraw these meds to avoid delay in administration time for pts who now must come in 5 days/week. This ensures quick visits and guarantees the patients get their medicine administered correctly. The syringes are pre-filled and placed in trays in locked cabinets for quick and easy administration by staff to patients. These meds are stable to predraw syringes and retain potency. All pts on Serostim get the same does, 6mg/day. I have about 12 patients currently on Serostim, 30 does per pt per month. . . . Procrit has a tremendous street resale value, but only if it is in unopened vials - - can be sold on the street. By pre-drawing this and refrigerating it -- locked -- we prevent patients from [?] to take vials home & sell them. Instead they reliably get their weekly injection until they are no longer anemic & then it is stopped. On 11-29-01 I have about 20 pre-filled Procrit syringes. I have about 200 Serostim pre-filled syringes today. Neupogen . . . has a street resale value of over $1000 box for 10- unopened vials. Patients are tempted to sell the Neupogen vials when I receive them. I have 20- pre-filled now. . . . Dr. Wolland admitted that there were pre-filled syringes of Procrit and Neupogen found during the November 29, 2001, investigation during her testimony at hearing. She denied, however, that she knew about the pre-filled syringes of Serostim. In rejecting the admission in her sworn written statement that "I have about 200 Serostim pre-filled syringes today," Dr. Wolland testified that she was told to include that statement. Dr. Wolland's explanation is rejected. It is rejected because, not only did she make the statement under oath, she also told two different individuals, Inspector Lozowicki, and Ms. Ghabrial, that the pre-filled syringes in the Procrit bags contained Serostim. Dr. Wolland has also asserted at hearing and in her post-hearing argument that the 200 pre-filled syringes of Serostim were proved, subsequent to November 29, 2001, to have been filled by two then employees of Sunshine, Myra Williams- Wright and Sherry Farmer, who she testified intended to steal the medication. Dr. Wolland's testimony on this matter has not been credited. Her testimony in this regard was not based upon personal knowledge, but instead was based upon a Plea Agreement in the case of State of Florida v. Myra T. Williams-Wright, Case No. F02-3243, in the Circuit Court of the Eleventh Judicial Circuit in and for Miami-Dade County, Florida. That Plea Agreement does not support Dr. Wolland's speculation. First, although official recognition was taken of the Plea Agreement, which contains no reference to the 200 pre-filled syringes, and a transcript of an "Audiotaped Interview of Myra Williams-Wright Taken on February 1, 2002 by Investigators Thomas Vicente, Richard Bowden & Raymond Alamo," these pleadings are not part of the evidence of this proceeding. Having only taken official recognition of these documents, the only findings that can be made are that Ms. Williams-Wright entered a plea and that she gave a statement in a criminal proceeding which did not directly involve this matter. These are facts which are not relevant to this proceeding. Secondly, even if the contents of the pleadings are considered, they do not support Dr. Wolland's theory. The Plea Agreement makes no reference to Sunshine or the events of November 29, 2001. As to the transcript of Ms. Williams-Wright's statement, while she does indicate that she was involved in the theft of medications from Sunshine, including pre-filled syringes, no where in her statement does she make any reference to the pre-filled syringes found at Sunshine on November 29, 2001, and, in particular, the 200 pre- filled syringes which Dr. Wolland admitted knowledge of in her sworn statement and to two different people involved in the inspection contained Serostim. While the Department proved the general manner in which the Procrit and Neupogen syringes were stored, it failed to prove clearly and convincingly where they were stored: on the shelf of the cabinets, as depicted in Petitioner's Exhibit 3y; the counter-top under the cabinets as depicted in Petitioner's Exhibit 3z and 3aa; or in the refrigerator, as testified to by Dr. Wolland.13 As to the Serostim, they were stored on the top shelf of one of the cabinets in the Infusion Preparation Room and were not refrigerated. Dr. Wolland's testimony to the contrary is rejected as lacking credibility. As to the Novolin, although it was stored in the refrigerator, unexpired and expired boxes were stored together. The Department failed to prove that Dr. Wolland's improper storage of Procrit, Neupogen, Serostim or Novolin constituted "[p]rescribing, dispensing, administering, supplying, selling, giving, mixing, or otherwise preparing a legend drug, including all controlled substances, other than in the course of the osteopathic physician's professional practice." (Emphasis added). The evidence proved that all of the medicines were maintained in the course of Dr. Wolland's practice. While Dr. Wolland testified at hearing that she only pre-filled enough syringes to meet the needs of the patients she saw in a day, the number of syringes pre-filled with Procrit, Neupogen, and Serostim found in the Infusion Preparation Room exceeded the number of patients which could reasonably be expected to need those drugs on November 29, 2001. The Medication Storage Laboratory. The Medication Storage Laboratory was locked when the inspection began and was opened to allow the inspection team to enter. A refrigerator, approximately 12 to 15 cubic feet, was used to store medications, in large part vaccinations used primarily for children, in the Medication Storage Laboratory. Insulin was also stored in this refrigerator. There was no locking mechanism on the refrigerator. On November 29, 2001, the refrigerator was found to contain, among other things, several plastic trays containing pre-filled, unlabeled syringes. Petitioner's Exhibit 3d is an accurate depiction of the contents of the refrigerator at the time it was first opened on November 29, 2001. In addition to the medications found in the refrigerator, there was a large plastic bottle of Zephyrhills water. The trays themselves containing the pre-filled syringes which were found in the refrigerator had paper labels attached to them. The type of medication the syringes contained had been written on those labels. There was no other identifying information on the paper labels or the syringes, such as when the syringes were drawn, the expiration date of the medication, the medication "lot number," or who the syringes were intended for. The syringes themselves were, to the extent visible in Petitioner's Exhibit 3b, identical and indistinguishable. Therefore, if one syringe meant for one tray was incorrectly placed in another tray, which in a practice as large as Dr. Wolland's was highly probable, there would be no way of knowing. One tray, labeled as "DTAP," contained a clear liquid in which some of the syringes were sitting. This tray was located below the spout of the Zephyrhills water bottle. While there was a blueish-green substance floating in the liquid and one of the syringes appeared to have a foreign substance of a green/gray color inside it, the evidence failed to prove what these substances were. The evidence also failed to prove what the liquid was.14 It could not be accurately determined from any information kept with the syringes or the trays when the pre- filled syringes found in the refrigerator were filled. Even Dr. Wolland admitted that they could have been filled the day before or even two days before November 29, 2001. Dr. Wolland's testimony concerning the pre-filled syringes, in particular, how they could be identified by her or anyone else who used those syringes, has not been credited. While she gave testimony as to how a pre-filled syringe might be identified, she was unable to explain how the pre-filled syringes found in the refrigerator were actually identifiable. Even her explanation of how pre-filled syringes might be identified was inconsistent. At one point, she gave the following explanation of how the contents of the trays of pre- filled syringes found in the refrigerator might have been identified: Q. Let me ask you this. Commonly, before November 29, 2001, those baskets that are in this refrigerator, are the contents labeled at all, the contents themselves? A. Yes. Q. How? A. They're labeled, should have a sticker, each syringe, saying the type of medication in it. And within the basket should be the vial they're drawn from, to ascertain the lot number, because every vaccine that is administered has a lot number in both the patient's chart and the vaccine log, it's a must, every shot has to have a lot number, it must and it does. [Emphasis added]. Transcript, page 696, lines 10-21. On further inquiry, she testified as follows: Q. The vaccines that were in the refrigerator, you're saying that each vaccine that was in a syringe should have a label on it. Is that correct? A. It should have a label on it, or it should -- it should -- for example, like the DPT tray should have, that DPT tray should not be just syringes containing probably the DPT, they should have the box of DPT with the vial, and should fill up a syringe, give it to the patient, or there could be three or four syringes in there for the morning, which in that case, as long as it's with the log and the vial it came from, because the lot number must be identified, that should be sufficient. . . . . . . . Q. According to you, the individual syringes that are located in the refrigerator should be labeled. Is that correct? A. They could be labeled. If they are with the bottle that it's drawn from taken from the bottle, with its bottle, I don't know that is necessary. I don't think there is a law that says that is necessary. Transcript, page 698, lines 15-25, and page 699, lines 1-3 and 9-15. More importantly, the evidence proved that Dr. Wolland had failed to use any appropriate method of identifying the individual pre-filled syringes found on November 29, 2001, in the refrigerator in the Medication Storage Laboratory. The refrigerator also contained expired and unexpired manufactures boxes of Novolin (insulin). Why Dr. Wolland maintained expired insulin was not explained. There were also cabinets in the Medication Storage Laboratory. Unlike the Infusion Preparation Room, these cabinets were not locked. There was also no area of the cabinets designating the contents as being held for destruction. What was contained in the cabinets was not proved by the Department. The Department failed to prove that Dr. Wolland's improper storage of the pre-filled syringes and the Novolin in the Medication Storage Laboratory constituted "[p]rescribing, dispensing, administering, supplying, selling, giving, mixing, or otherwise preparing a legend drug, including all controlled substances, other than in the course of the osteopathic physician's professional practice." (Emphasis added). The evidence proved that all of the medicines were maintained in the course of Dr. Wolland's practice. Dr. Wolland's Use of Pre-filled Syringes and Adulterated and Expired Medications Dispensed to Other Patients. In her sworn, written statement, in statements to investigators, and at hearing Dr. Wolland admitted that she administered or had her staff administer pre-filled syringes to patients. Her written statement on this matter is quoted in paragraph 59. Dr. Wolland also admitted to Investigator Lozowicki that Adulterated and Expired medications, which she admitted her patients had given to her for destruction, were sometimes given to other patients "who may have run out or need a few for a few days." Although Dr. Wolland denied at hearing that she ever used medications in this manner and denied making such an admission to Investigator Lozowicki, her testimony has not been credited. Inspector Lozowicki's testimony has been accepted as credible, in large part because she memorialized Dr. Wolland's admission in a Memorandum to the MFCU Bureau Chief the day after the inspection: She said that she requested from her patients that they bring to her the medications that the patient is no longer taking so they won't get confused with the other medications they are currently taking. She uses these drugs to give to other patients who may have run out or need a few for a few days. The Standard of Care. Joel Rose, D.O., was accepted as an expert in the field of osteopathic medicine. Dr. Rose, who is board certified by the American Osteopathic Board of Family Physicians, has been a licensed osteopathic family physician in Florida since July 1984. Dr. Rose described his current practice as follows: I have a solo private practice in Tampa, Florida. I treat patients, mostly adolescent through senior years, with all varieties of conditions within the scope of family medicine. Transcript, page 443, lines 16-19. As for his treatment of HIV positive patients, Dr. Rose indicated the following in response to a question as to whether HIV positive patients were the primary scope of his work: No, it's probably the minority scope, because the practice is not dedicated to that exclusively, but there in our area there's very few primary care physicians who will handle an immunocompromised patient, and less of them every day. Transcript, page 443, lines 22-25, and page 444, line 1. Dr. Rose, "at different points in [his] practice" has prescribed "Procrit, Neupogen, Deca-Durabolin, Serostim, [and] Novolin." Dr. Rose's practice is very dissimilar from Dr. Wolland's practice on November 29, 2001. Depending on the issue, it might even be concluded that he is not "a reasonably prudent similar osteopathic physician." As to the issues in this case, however, which involve only the proper storage and use of medications, Dr. Rose qualified to opine on "the level of care, skill, and treatment which is recognized by a reasonably prudent similar osteopathic physician as being acceptable under similar conditions and circumstances" and his opinions, which were unrebutted, have been credited. Dr. Wolland improperly stored pre-filled syringes and expired Novolin, as found, supra. While her improper storage of may by itself constitute a violation of the standard of care imposed on osteopathic physicians, no such charge has been made in the Administrative Complaint. Instead, the Administrative Complaint charges that she violated the standard of care by injecting "improperly stored medications into patients." Dr. Wolland admitted that, while she had not yet done so, she intended to use the improperly labeled and stored pre-filled syringes on her patients and that she had used such pre-filled syringes stored in such manner as pre-filled syringes were found on November 29, 2001, on her patients. She has, therefore, violated the standard of care by injecting unlabeled and improperly stored medications into patients. Dr. Wolland also violated the standard of care by administering "medications to patients from other patient's open pharmacy purchased bottles." Finally, the evidence failed to prove that Dr. Wolland violated the standard of care by keeping "large quantities of expired medications in her office stored with medication that had not expired." While she commingled expired and unexpired Novolin, Dr. Rose did not offer an opinion as to the inappropriateness of Dr. Wolland's storage of Novolin.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the a final order be entered by the Board of Osteopathic Medicine: dismissing Count One of the Administrative Complaint; finding that Shelly O. Wolland, D. O., has violated Section 456.072(1)(x), Florida Statutes, as described in this Recommended Order; requiring that she pay a fine in the amount of $10,000.00; suspending her license for a period of two years followed by three years of probation; and requiring that she complete continuing education in medication storage as directed by the Board of Osteopathic Medicine. DONE AND ENTERED this 12th day of October, 2005, in Tallahassee, Leon County, Florida. S LARRY J. SARTIN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 12th day of October, 2005.
The Issue Whether Respondent violated Subsection 456.072(1)(aa), Florida Statutes (2003),1 and, if so, what discipline should be imposed.
Findings Of Fact The Department is the state agency charged with the regulation of medicine pursuant to Chapters 20, 456, and 458, Florida Statutes. Dr. Weiner, is and was at all times material to this proceeding, a licensed physician in the State of Florida, having been issued license number ME76902. He has been practicing medicine for 23 years and has not previously been the subject of a disciplinary proceeding. Dr. Weiner is board-certified in anesthesiology. S.M. has been a patient of Dr. Weiner since 1999. S.M. sought treatment from Dr. Weiner for his lower back pain that he suffered as a result of a golf cart injury. Over the course of his care under Dr. Weiner up until the date of the incident, S.M. received numerous treatments for his back pain, including radiofrequency ablation and epidural steroids. Radiofrequency ablation uses a specific frequency of radio waves to help put specific pain nerves that go to the joints of the spine to sleep for a period of time. In this procedure a steroid is deposited inside the epidural space outside the spine. The procedure can help to treat back pain as well as pain extending down the legs of the patient. On January 29, 2005, S.M. presented to Dr. Weiner with complaints of lower back pain. After examining S.M., Dr. Weiner recommended that S.M. undergo a radiofrequency ablation procedure. Dr. Weiner ordered the radiofrequency ablation procedure and instructed his office to coordinate with the Center for Digestive Health and Pain Management (Center), to have the procedure scheduled. The Center, which is a separate facility from Dr. Weiner's office, scheduled S.M.'s treatment for February 19, 2004. The Center scheduled S.M. for a Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach, rather than the radiofrequency ablation procedure. A Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach, involves placing a needle down near the tailbone. A catheter is inserted through the needle into the space around the spine. A steroid medication is injected through the catheter. The purpose of the procedure is to decrease irritation and inflammation of the nerves as well as the discs. S.M. could have derived some benefit from the Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach. Patient charts at the Center are separate from the patient charts at Dr. Weiner's office. The Center's charts are made up by the Center staff and consist of forms for the specific procedure, a template of the procedure for the specific procedure, the nursing notes, billing sheets, and other administrative paperwork. When the Center erroneously scheduled S.M. for a Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach, the Center prepared paperwork necessary for the provision of that technique, including consent forms. On February 19, 2004, S.M. went to the Center with the belief that he was going to receive the radiofrequency ablation procedure. During this visit, S.M. was in a lot of pain and was eager to receive treatment for his back. Upon arrival to the Center, S.M. signed a consent form that referenced a Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach procedure. The nurse then confirmed with S.M., the technician, and Dr. Weiner that S.M. understood this procedure. Dr. Weiner also explained the Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach, to S.M before administering the treatment and also told S.M. that this was the first time he had undergone this procedure while under Dr. Weiner's care. Subsequent to signing the consent form, S.M. got undressed and was hooked up to an IV. He was then moved to another bed, and Dr. Weiner started to perform the Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach, on S.M. Dr. Weiner administered a local anesthesia and began to insert the tip of a needle into S.M.'s back. After partially inserting the needle in S.M.'s back, Dr. Weiner stopped the procedure and reviewed S.M.'s chart. He requested that S.M.'s chart that was in Dr. Weiner's office be brought to the Center. The chart revealed that the Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach, was not the procedure that was originally ordered at S.M.'s appointment on January 29, 2004. Once he realized the discrepancy, Dr. Weiner apologized to S.M. and explained that he began to do the wrong procedure. S.M. was then taken to the recovery room, and Dr. Weiner ordered the radiofrequency ablation procedure for a later date. S.M. did not receive the complete Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach, procedure on February 19, 2005. In or about March 2004, S.M. returned to the Center and had the radiofrequency ablation procedure completed.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that James P. Weiner, M.D., violated Subsection 456.072(1)(aa), Florida Statutes; issuing a reprimand; imposing a $1,000 fine; requiring 25 hours of community service; and requiring five hours of risk management education. DONE AND ENTERED this 31st day of March, 2006, 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 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 31st day of March, 2006.
Findings Of Fact B. G. Gross, M.D. is licensed by the Florida State Board of Medical Examiners and the Hearing Officer had jurisdiction over the Respondent and the offenses alleged. Gross is certified by the American Board of Dermatology. Amending Title 21 U.S. Code in 1962 led to the Food and Drug Administration (FDA) curtailing the interstate transportation of liquid silicone by declaring the use of liquid silicone by injection for soft tissue augmentation to be an experimental procedure. This made liquid silicone, intended for this use, a "new drug" as defined in 21 U.S.C. 321(p). Thereafter shipment of such drug could be made only to the seven named clinical investigators (later augmented to eight) approved by FDA for experimenting, under controlled and regulated procedures, on the use of injectable silicone in humans. Injections for mammary augmentation was not included in the approved use. Between 1967 and 1969 Gross engaged in correspondence with Dow to obtain liquid silicone from Dow suitable for injecting. Specifically Gross attempted to obtain Dow-Corning 360 Medical Fluid and be denominated a clinical investigator authorized to experiment with injectable silicone by injecting into humans. In 1967 following the commencement of this correspondence Gross executed an affidavit that he would not inject any Dow-Corning 360 Medical Fluid "hereafter received by me from Dow" into humans but would use same only for experimenting on animals, and Dow forwarded to him one pint of such silicone. Having no further success obtaining silicone shipped to him in Miami from Dow, Gross investigated the possibility of obtaining Dow 360 in Bermuda but here too he was unsuccessful. A subsequent attempt to be designated as a clinical investigator authorized to experiment with injectable silicone designated MDX-4-4011 fluid was also unsuccessful. This latter fluid differs from Dow 360 principally in being shipped in sterile ampules of 1cc and 5cc capacity and being subject to stricter manufacturing controls. Breast augmentation has been performed by some practitioners for many years. The process was greatly discredited in the 1920's when the medical profession became aware of the disastrous results associated with the use of paraffin for breast augmentation. The most experienced practitioner in this discipline today is probably Dr. Sakurai of Tokyo, Japan, who started such work in the mid-1940's. Subsequent to the discovery of silicone Sakurai used silicone to which he added some undisclosed organic oil to create an irritative reaction which would wall off the injected silicone to keep it immobile. The Sakurai Corporation was incorporated in California in 1962 to market this product and in March, 1963 was granted an investigative exemption to permit the use of this product for breast tissue augmentation. This investigational exemption was terminated on May 17, 1963 because the sponsor failed to submit requested data on manufacturing controls, animal toxicity and labeling. Prior to liquid silicone being classified as a "new drug" in 1963 Dow- Corning 360 Medical Fluid was available from drug supply houses and had been used by practitioners in this country as well as in Europe and Japan for breast augmentation. Although silicone is inert, non-toxic, water repellent and does not stimulate immunologic reaction as do many other materials implanted in the body, prior to the time the FDA classified liquid silicone as a "new drug" many scientists had concluded that its use was contraindicated for breast augmentation. Literature forwarded to Gross by Dow (Exhibit 11) when he inquired about the use of liquid silicone contained the following quotations: "Dow Corning does not feel that this material can be recommended for human injection." "... The FDA called a halt to the use of injectable silicone by classifying silicone for injection into humans as 'new drugs'. The agency prohibited the use of silicone on humans until specific research had been undertaken to determine its safety and effectiveness under a claimed investigational exemption." "Recent and preliminary experimental evidence has indicated that silicone fluids may be transported to far removed tissues and organs, but much more work must be completed before definite conclusions are reached." "Cautions Warranted. The present suggested clinical misuses of silicone fluids are as follows: 1. Mammary augmentation.* *Although the results in a selected group of cases injected properly and conservatively (not over 5 to 10 cc at any one time) have been encouraging, the continued use in this respect, since the filing of the IND with the FDA, has been postponed until a long-term follow-up has been established and these earlier results have been completely evaluated." "The contention that a causal relationship may exist between breast implantation and the subsequent development of mammary cancer cannot be answered definitely at this time." "The Federal Food and Drug Administration has stated that the injection of silicone fluids either in the pure form or as mixtures with other materials, con- stitutes a 'drug use'. Therefore the fluid used in this manner is a 'new drug' and specific investigative procedures must be followed to establish its safety and effectiveness." "Furthermore, it is well to note that the use of silicone fluid for breast augmentation has for many years been considered unwise by those clinical investi- gators most experienced with this material, because the volumes required are far in excess of those which were found safe for local administration. More importantly, examination of breasts for natural diseases is made difficult or impossible after injection with silicone fluid because of the distortion of the normal breast architecture which occurs." Dr. Gross has been interested in silicone injections since he was taking his residency in California in 1962. His testimony that he purchased some 5 or 10 gallons of Dow 360 Medical Fluid from a medical supply house in California in 1962 (before Dow took it off the market) in 500 cc (one pint) bottles (the standard size in which this material was packaged) subsequently poured these pint bottles into one gallon Chlorox bottles he had washed out, and transported this material to Florida where he kept these jars in his garage for several years before using it for injection, is simply not credible. Although denied by Gross, more than one of the witnesses testified that Gross told them the silicone he injected contained linseed oil. This would indicate that the silicone used by Gross possibly came from the Sakurai Corporation and was acquired by Gross on the "bootleg" market. Gross' interest in injectable silicone led him, according to his own testimony, to read all medical literature on the subject he could locate. In Exhibits 12, 13, and 18 with which Gross claimed familiarity the following appears: "Abuse of the material must be prevented because most problems and complications from improper use of liquid silicone are difficult to treat since the fluid cannot be retrieved from the tissues once injected." "During the past ten years, a high proportion of women who live here have had some type of 'liquid silicone' injection, despite intensive educational campaigns by physicians, hospitals, and the Medical Society. One estimate is that at least 12,000 women have had 'bootleg silicone injections' mostly in the breast area, and that at least one percent of them developed some type of problem each year." "...the more common localized problems, such as: infection, migration, cyst formation, deep tissue silicoma formation, and degrees of skin involvement from pigmentation to gangrene." "Although the problems we see in clinical practice in Las Vegas are said by Dow Corning representatives to be a result of injections of some type of 'liquid silicone' other than their 'medical grade 360', we have seen a number of the problems definitely from cases originally injected with 'medical grade 360' legitimately released for research several years ago." "The dream of a safe and simple method of correction of contour defects with injection of liquid silicone has not materialized despite ten years of intensive research by qualified investigators." "Examples of migration of silicone from the breasts into the axilla and chest wall are illustrated. At present, injection of silicone for purposes of breast augmentation is prohibited by the Food and Drug Administration. Precise information regarding the purity, type, and quantity of silicone injected is therefore difficult to obtain." "Since the injected silicone is relatively dense and often produces palpable masses, routine mammograms are suggested in patients with a history of silicone injections in the breasts. This examination could serve as a base line for comparison with subsequent studies, should malignant tumor be suspected at a later date." Dr. Gross injected liquid silicone into the breasts of Diane A. Carter, Dorothy Belcher, Ann Kern and Vicki Diaz, in addition to other patients not named in the Complaint. His normal practice was to inject 80 cc of silicone into each breast on the first visit. Many of his patients for breast augmentation returned for three treatments. The complaining witnesses all learned of Gross through friends and most of them first visited Dr. Gross' office in company with a friend. In response to inquiries about the process Gross assured the patients that following the injection of silicone their breasts would be beautiful. Although Gross later commenced using a release form which he had his patients for mammary augmentation sign, "because my lawyer thought it a good idea," even then he did not fully explain the potential hazards of silicone injection to these patients. The patients receiving treatment before the advent of the release (Exhibit 9) likewise were not fully advised of the hazards involved with silicone injections. Gross advised his patients that if lumps formed they could be broken up by finger pressure or squeezing which would break up the silicone into small globules. Initially all complaining witnesses were pleased with the result of the silicone injection. However they developed tenderness, inflammation and lumps in their breasts some months after their injections. None of them returned to Gross for treatment but instead went to family doctors (or plastic surgeons) who referred them to plastic surgeons for consultation. All of these witnesses were advised that the silicone could be removed only by mastectomy and that such drastic procedure was not recommended at the present time with the present discomfort they are suffering. No other method of removing injected silicone is presently available. Dr. Gross testified that he used only Dow Corning Medical Grade 360 silicone, although, since he told at least two of the witnesses in his office that the silicone used contained linseed oil, it is likely that he used both Dow 360 and other silicone. At the hearing Dr. Gross produced a nearly full bottle of Dow Medical Grade 360 silicone which was the bottle he received from Dow after executing the affidavit that he would not use that material for injection into humans. The missing silicone, according to Gross, was given to one of the dermatologists in his office. The amount removed from the 500 cc bottle, approximately 100cc, was not enough for Gross to have done a breast augmentation on one patient. No evidence was adduced that Gross used the Dow Medical Grade 360 received as a result of his affidavit for injection into humans. The Food and Drug Administration has no power to control a doctor engaged in the practice of medicine. Those authors quoted above are technically incorrect when they say the FDA has made the use of liquid silicone unlawful for mammary augmentation. By declaring injectable silicone a new drug the FDC has made it illegal to ship or transport this material in interstate commerce except to those licensed investigators approved to conduct clinical investigations. As stipulated by the parties, Gross was not a licensed investigator authorized to inject liquid silicone into humans. If Gross' testimony is true that he acquired the silicone injected into the breasts of the four complaining witnesses in 1962 while he was a resident in California, this material was moved from California after the effective date of 12 U.S.C. 355, viz Oct. 10, 1962. Exhibit 17, Curriculum Vitae of Bernard G. Gross, shows that Gross was resident in dermatology, Veterans Administration Hospital, Los Angeles, California 1962-1963; Chief Resident in dermatology, Boston City Hospital, Boston, Mass. 1963-1964; and Instructor, Department of Dermatology, University of Miami School of Medicine, Miami, Florida 1964-1965.
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 Respondent's alleged violation of subsections 460.13(3)(f) and (g)(1), Florida Statutes. At the commencement of the hearing, petitioner withdrew Count I of the complaint that alleged a violation of Rule 21D-2.01, F.A.C. and subsection 460.13(3)(g)(1), Florida Statutes.
Findings Of Fact Respondent was a licensed chiropractor in the state of Florida on December 26, 1976, and is so licensed at the present time. His office is located in North Miami Beach, Florida. (Stipulation, Exhibit 2) Respondent received his professional education at the Palmer College of Chiropractic in Davenport, Iowa. After graduation, he interned for a period of approximately six months until October, 1976. While at the Palmer College, he studied the Grostek method of diagnosis and treatment that is part of the school curriculum. This method teaches that all of the nerves connected to the spinal cord are affected by bone misalignment in the upper cervical area. This can have adverse affects upon the spine and a person's general health. Diagnosis of this condition is made by the use of x-rays. Once a bone misalignment is determined to exist, the chiropractor uses light pressure or force adjustment to reposition the bone. Finally, x-rays are again taken to see if the desired change has been effected by the treatment. This method is restricted to the cervical area below the base of the skull. Respondent also is a member of the National Upper Cervical Chiropractic Association (NUCCA) that espouses a more refined Grostek method involving only a different stance of the chiropractor in making the bone adjustment. That organization conducts continuing education courses, performs research and issues regular monthly bulletins. Although there are several hundred chiropractors in the United States who practice the NUCCA method, at present there are only three in Florida. The Grostek method originated approximately twenty-five years ago. Although the Grostek technique is not used extensively in Florida, it is an accepted method of diagnosis and treatment in the profession. The primary difference in the Grostek and NUCCA techniques and that used by other chiropractors is the manner in which x-rays are utilized. Respondent specializes in the NUCCA method and if he does not discover a bone misalignment in the cervical area, he refers the patient to another chiropractor. (Testimony of Respondent, Dr. Carroll, Exhibits 2, 3) While at Palmer College, respondent also received lectures on the subject of iridology. This topic deals with the matter of toxic areas in the body and involves the examination of the iris of the eye to determine what area of the body is affected. The chiropractor may recommend a change in diet as a means of removing a particular problem. Iridology is an accepted adjunct to chiropractic treatment and is employed by respondent in his practice on occasion. However, it is entirely separate and apart from the NUCCA method. (Testimony of respondent) A reporter for the North Dade-South Howard Journal asked the respondent for an interview to explain the NUCCA method. He had been referred to respondent by one of the latter's patients. Respondent granted the interview and the subsequent conversation included matters concerning both NUCCA and iridology. The article was not submitted to respondent for approval prior to publication, and was published in the newspaper on December 26, 1976. It contained misquotes, inaccurate summations of the interview and implied that iridology was a part of the NUCCA method. Although the article referred to a claim of respondent that by detecting toxicity in the body with a small flashlight and a magnifying glass, the need for exploratory surgery in patients could largely be eliminated, respondent denied making such a statement. A witness testified at the hearing that the same reporter grossly misquoted her in an article concerning the benefits of a vegetarian diet. (Testimony of respondent, Galton, Exhibit 1)
Recommendation That the Administrative Complaint against respondent be dismissed. Done and Entered this day of August, 1977, in Tallahassee, Florida. THOMAS C. OLDHAM Hearing Officer Division of Administrative Hearings 530 Carlton Building Tallahassee, Florida 32304 COPIES FURNISHED: Ronald LaFace, Esquire Post Office Box 1572 Tallahassee, Florida 32304 Herbert L. Fehner, Esquire 300 Marine Plaza on the Intracoastal 3100 E. Oakland Park Boulevard Ft. Lauderdale, Florida 33308
