Daily Rules, Proposed Rules, and Notices of the Federal Government
On June 17, 2011, Administrative Law Judge (ALJ) Gail A. Randall issued the attached recommended decision.
Having considered the entire record and the Government's exceptions, I have decided to adopt the ALJ's decision except for her legal conclusions with respect to whether the Respondent issued prescriptions for controlled substances to several undercover officers and several of her findings under factor five. However, because I otherwise agree with the ALJ's findings as to the public interest factors, I adopt her ultimate conclusion that the Government has shown that "Respondent's continued registration would not be in the public's interest" and that the Respondent "has not accepted responsibility for all of her wrongdoing, nor has she adequately assured this tribunal of future compliance." ALJ at 64. I will therefore order that Respondent's registration be revoked and that any pending application be denied.
The ALJ concluded that the Government failed to establish that Respondent's prescriptions to three undercover officers (UC) lacked a legitimate medical purpose. ALJ at 42-51; see
The ALJ also noted that "expert testimony may not be required" where the evidence shows that a registrant "has acted in a manner that clearly contravened state law governing what constitutes a legitimate medical practice," such as where a physician
I agree with the ALJ that where the Government fails to provide expert testimony to support a finding that a practitioner acted outside of the usual course of professional practice and lacked a legitimate medical purpose, it can nonetheless prove a violation by: (1) Providing evidence that a practitioner committed a violation of a state medical practice standard which is sufficiently tied to a state law finding of illegitimacy to support a similar finding under Federal law," or (2) providing evidence showing that Respondent knowingly diverted drugs. However, I also conclude that a violation of a state medical practice standard which has a substantial relationship to the CSA's purpose of preventing substance abuse and diversion is also sufficient to support a violation of 21 CFR 1306.04(a). Moreover, I disagree with the ALJ's conclusion that the Government has not proved a violation of the CSA's prescription requirement.
In its exceptions, the Government argues that it proved that Respondent did not perform a physical examination of either UC1 or UC2. Gov. Exc. at 3. The ALJ found otherwise, noting that Florida law does not define the term "physical examination," and that at the time of the events at issue here, the meaning of the term under the State's law was "nebulous." ALJ at 47 & n.25. The ALJ further explained that Respondent's "interpretation, in light of the Government's failure to provide a contrary one, must be given considerable weight" and that Respondent had explained that "[a] physical examination does not necessarily entail touching the body" as "in the case of chronic injury 'you can't see--whether you're putting your hands on the patient or not, you can't see that evidence of chronic inflammation and disease by visual inspection or palpation."
It is far from clear why Respondent's explanation should be entitled to "considerable weight" given the ALJ's acknowledgment that it "has the potential for being self-serving," ALJ at 43 n.23; and appears to be patently disingenuous.
However, I need not decide whether Respondent performed a legitimate physical exam of any of the undercover officers, or whether, as the Government argues, "the plain meaning of the term 'physical examination' is that a physician [must do] something more than watch the patient walk into her office." Gov. Exc. at 5. Here, the record contains sufficient other evidence to conclude that Respondent both: 1) knowingly diverted drugs, and 2) violated State medical practice standards that have a substantial relationship to the CSA's purpose of preventing drug abuse and diversion so as to support a finding that she acted outside of the usual course of professional practice and lacked a legitimate medical purpose in issuing the prescriptions. 21 CFR 1306.04(a).
As the ALJ recognized, the Florida Board of Osteopathic Medicine has, by regulation, promulgated "Standards for the Use of Controlled Substances for Treatment of Pain." ALJ at 47 (citing Fla. Admin. Code Ann. r.64B15-14.005). The Board has explained that the standards "communicate what the Board considers to be within the boundaries of professional practice." Fla. Admin. Code Ann.r.64B15-14.005(1)(g).
The first of these standards is the Board's standard for "Evaluation of the Patient." This provision states:
Of note here, even if the Government has not proved that Respondent's physical examination was medically inadequate to support her diagnoses of UCs 1 and 2, the evidence shows that Respondent's evaluations of them failed to comply with the Board's standards in several other ways. Moreover, because these violations have a substantial relationship to the CSA's purpose of preventing drug abuse and diversion they support the conclusion that the prescriptions violated 21 CFR 1306.04(a).
At her first visit, UC1 (Tanya Hall), who indicated that she was from Illinois, obtained a prescription for 180 oxycodone 15 mg, as well as 30 Xanax 2mg.
Notably, during an encounter with UC3 (which occurred the same day), Respondent explained that under her pain scale, pain between 1 and 3 was "mild pain," that pain at level 4 was "comfortable pain," and that at this level, "I can do whatever I want to do because the pain is just not that bad." GX 13B, at 12 & 14. Respondent then asked rhetorically: "Is that the time to take a break with narcotic, an opiate, a dangerous heroin related drug? No, it's not."
Moreover, when Respondent asked UC1 "what kind of medicine have you been on?," UC1 reported that she had been taking Vicodin and Tylenol III (a drug with codeine). GX 14B, at 10. However, Respondent did not ask her whether she had previously been (or was currently being) treated by another physician, and if so, what treatments had been tried.
At UC1's second visit (Mar. 22, 2010), Respondent indicated on the progress note that UC1 had pain levels of 6-7/10 and 2-3/10.
On April 20, 2010, UC1 and UC2 returned to Respondent. Once again, they saw Respondent together. While at this visit, UC1 indicated that 2 was her "acceptable level of pain," she left blank the entries on the pain assessment form for indicating the "[p]resent" intensity, the "[w]orst pain gets," and "[b]est pain gets." RX1, at 21. Moreover, during the visit, Respondent did not ask her any questions regarding her pain levels and asked her only if she was getting in the pool and the frequency of her doing so, and whether the dosing of the Xanax was working well for her. GX 17C, at 7; 17D, at 6. Respondent, however, issued UC1 more prescriptions, including one for 180 Oxycodone 15 mg and 30 Xanax 2mg. RX1, at 22.
As for UC2, who also represented that he was from Illinois, at his first visit he listed "stiffness in neck" as the reason for his visit; however, he left the form for indicating his general health history entirely blank. RX 2, at 5, 12. Moreover, on his pain assessment form, UC2 rated his pain intensity as a 2 on a scale of 1 to 10 and left the rest of the form blank including the entries for describing the "quality," "onset", "manner of expressing," "what relieves your pain," and "what causes or increases your pain."
When Respondent asked UC2 what medicine he had been on, UC2 stated that he had not "gotten anything from a doctor" and he "was just getting some Oxys from a friend * * * because that was the only thing that was helping my neck." GX 15B, at 34. Respondent noted that UC2 had "one * * * mild bulging disc * * * which is basically what Tanya has."
Subsequently, Respondent noted that UC2 had one bulging disc, which was neither torn nor herniated, and was "not even pressing" on a nerve; Respondent advised that this condition did not warrant oxycodone 30 mg and required only 10/325.
Respondent noted that if UC2 used his pool program and stayed on the Ibuprofen, UC2 would not need to spend $200 on oxycodone "which you don't need."
Finally, Respondent got around to asking UC2 how he got hurt.
Here again, notwithstanding that UC2 never represented at this visit that he had pain higher than level 2, Respondent issued him prescriptions for 180 oxycodone 15 mg and 30 Xanax 2mg (as well as Ibuprofen and Soma). Moreover, on the progress note documenting the visit, Respondent wrote that UC2 had a neck injury and that his "pain comes & goes," but did not document any pain level. RX 2, at 1.
As noted above, on March 22, UC2 and UC1 saw Respondent together. This time Respondent indicated in the progress note that UC2 had "Chronic left shoulder pain" and wrote pain levels of 6-7/10 and 2-3/10. RX 2, at 17. UC2 testified, however, that during the second visit, there was no discussion of whether he had pain. Tr. 297. UC2 further stated that he complained of having only stiffness in his neck, and not chronic pain in his left shoulder.
Likewise, at the third visit, UC2 noted a pain level of three on a form, but again complained only of a stiff neck. RX2, at 16; Tr. 300-01. On the progress note, however, Respondent noted that UC2 had pain levels of 6-7/10 and 2-3/10 and had "chronic left shoulder pain." RX 2, at 20. While Respondent asked UC2 how he was doing on "the 180 program," a reference to his oxycodone prescribing, to which UC2 answered "awesome," at no point during the visit did Respondent ask UC2 what his pain levels were.
UC2 testified that Respondent did not perform a physical examination of him at any of the three visits. Notwithstanding Respondent's testimony that she silently observed UC2, unexplained is the basis for her diagnosis that UC2 had "chronic left shoulder pain" when he never complained of anything other than a stiff neck.
As the forgoing demonstrates, even assuming that Respondent's silent observation of UC1 and UC2 constitutes a valid physical exam,
The ALJ did not address whether these requirements, which Respondent clearly violated, have a substantial relationship to the CSA's core purpose of preventing drug abuse and diversion so as to support a finding that Respondent lacked a legitimate purpose and acted outside of the usual course of professional practice in prescribing controlled substances to UCs 1 & 2. I conclude that they do.
For example, inquiry into whether a patient is currently being treated, or has previously been treated for pain, might reveal that the patient is engaged in, or has a history of, doctor shopping or other non-compliant behaviors consistent with self-abuse or diversion; such inquiry might also show that controlled substances were previously tried and not effective. Fla. Admin. Code r.64B15-14.005(3)(d)(noting important of reevaluating "the appropriateness of continued treatment"). Inquiry into the effect of pain on a patient's physical and psychological functioning would seem to be an essential step in determining whether the patient's report of pain is consistent with his level of function, and whether prescribing controlled substances is even medically indicated to treat a patient's pain, as well as the appropriate drug and dosage level, another critical step in preventing diversion and self-abuse. Likewise, inquiry into whether a patient has a history of substance abuse has an obvious relationship to the CSA's purpose. Finally, the failure to adjust drug therapy based on a re-evaluation of the patient could lead to a patient's becoming addicted or overdosing.
Respondent's failure to comply with these requirements with respect to UC1 and UC2 is fundamentally different than the situation at issue in
Moreover, Respondent's testimony makes clear that she does not accept responsibility for her misconduct in prescribing to the UCs. When asked by her own counsel whether her oxycodone prescriptions were medically appropriate, she asserted that they were because "the PDR allows up to 30-milligrams, which is twice the 15 that I recommended for these patients," Tr. 484, ignoring that UC1 and UC2 never complained of pain warranting prescriptions at this level of drug. Likewise, in addressing why she gave UC3 an extra twenty oxycodone pills after he requested them so that he could repay a friend, Respondent offered the disingenuous testimony that she did so so that UC3 would "have those twenty extra pills as a parachute" and she "didn't want him to worry."
It is true that at UC3's third visit, Respondent refused to give UC3 additional pills. However, here again Respondent gave false testimony, stating that she had told UC3 that "[i]f you know you're going to be short, you break and take half pills so you won't go into withdrawal." Tr. 513. However, as the transcript of the undercover visit makes clear, there was no discussion of withdrawal. Instead, she advised UC3 that if he owed people, he could break the pills and "take a fifteen instead of a thirty and that way" he could save the extras and "give the money back." GX 16B, at 22.
Respondent's advice to UC3 is fundamentally inconsistent with a registrant's obligation to prevent drug abuse; her giving of false testimony on this and other issues, as well as the numerous violations of the CSA which have been proved on this record make clear that she cannot be entrusted with a registration. Accordingly, I will adopt the ALJ's ultimate conclusion that Respondent's continued registration would be inconsistent with the public interest and her recommendation that I revoke her registration and deny any pending applications to renew or modify her registration.
Pursuant to the authority vested in me by 21 U.S.C. 823(f) & 824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of Registration FD1749057, issued to Jack A. Danton, D.O., a/k/a/Jacalyn A. Danton, D.O., be, and it hereby is, revoked. I further order that any pending application of Jack A. Danton, D.O., a/k/a Jacalyn A. Danton, D.O., to renew or modify her registration, be, and it hereby is denied. This Order is effective October 31, 2011.
Gail A. Randall, Administrative Law Judge. The then Deputy Administrator, Drug Enforcement Administration ("DEA" or "Government"), issued an Order to Show Cause and Immediate Suspension of Registration ("Order") dated November 19, 2010, proposing to revoke the DEA Certificate of Registration, Number FD1749057, of Jack A. Danton, D.O., ("Respondent" or "Dr. Danton "), as a practitioner, pursuant to 21 U.S.C. 824(a)(4) (2006), and deny any pending applications for renewal or modification of such
The Order asserted that the Respondent dispensed "inordinate amounts" of controlled substances, primarily oxycodone and alprazolam, under circumstances where the Respondent knew or should have known "that such prescribing and dispensing are for other than legitimate medical purposes and are outside the usual course of professional practice." [ALJ Exh. 1 at 2].
Next the Order asserted that many of the patients are from out of state, and that they have indicated that the Respondent failed to perform physical examinations and only accepted payment in cash. [
Next, the Order asserted that between February and April of 2010, the Respondent treated three law enforcement personnel, operating in an undercover capacity. At each of at least eight visits the Respondent issued prescriptions for other than legitimate medical purposes and outside the usual course of professional practice. The Respondent's prescribing of controlled substances to these individuals violated both State and Federal law, per the Order. [
By letter dated December 14, 2010, the Respondent, through counsel, timely filed a request for a hearing in the above-captioned matter. [ALJ Exh. 3].
At the Respondent's request, the hearing was held in Fort Lauderdale, Florida, on April 5-7, 2011. [ALJ Exh. 5-8; Transcript ("Tr.") Volume I-III]. At the hearing, Counsel for the DEA and Counsel for the Respondent called witnesses to testify and introduced documentary evidence. After the hearing, the Government
The issue in this proceeding is whether or not the record as a whole establishes by a preponderance of the evidence that the Drug Enforcement Administration should revoke the DEA Certificate of Registration Number FD1749057of Jack A. Danton, D.O., as a practitioner pursuant to 21 U.S.C. 824(a), and deny any pending applications to renew or modify this registration under 21 U.S.C. 823(f), because to continue Respondent's registration would be inconsistent with the public interest as that term is used in 21 U.S.C. 823(f). [Transcript ("Tr.") at 6].
I find, by a preponderance of the evidence, the following facts:
1. Respondent is registered with DEA as a practitioner in Schedules II-V under DEA registration number FD1749057.
2. Respondent's DEA registration expires by its terms on June 30, 2012.
3. The Respondent is a doctor of osteopathic medicine who practices in cosmetic dermatology, cosmetic surgery, and some family practice. [Tr. 378]. She has practiced in those areas for thirty-five years. [Tr. 379]. A greater percentage of her practice was "dealing with musculoskeletal injury." [Tr. 384]. In 2009, after the demand for cosmetic surgery declined, the Respondent added pain management to her area of practice. [Tr. 385-87].
4. Dr. Danton is a veteran of the United States Army and the Viet Nam war. [Tr. 379-80].
5. "Palliative care" means that "once the acute injury heals, that there's still something going on from either pinched nerves or some kind of pressure or spinal problems that cause the pain nerve to remain in active pain, even though the initial injury might heal." [Tr. 386]. Up to the time of the hearing, the Respondent treated from five to ten-thousand pain management patients seeking treatment for acute injuries all the way to chronic palliative care. [Tr. 390]. However, the Respondent is not Board certified in pain management. [Tr. 391].
6. At the hearing, Dr. Danton was recognized as an expert in the field of osteopathic medicine with extensive experience in pain management assessment and treatment. [Tr. 392].
7. Dr. Danton described how the human body becomes dependent on pain medications and how the body grows to tolerate pain medication. [Tr. 395-399]. The Respondent testified that she restricted her patients to taking four 15 mg oxycodone tablets a day. [Tr. 400].
8. In diagnosing muscular-skeletal injuries, the more important part of the diagnostic tools would be the MRI, for it is objective evidence of such an injury. [Tr. 558].
9. Prior to opening her own practice, the Respondent worked at a pain clinic called the Pain Center of Broward. [Tr. 554]. She also supervised a physician assistant, signing all the controlled substance prescriptions herself. The role of the physician assistant is to examine patients and to either continue or follow the physician's treatment plan, or if the physician assistant sees any noted change in the patient's condition based on the examination, to inform the physician of the change. The physician would write the prescription appropriately. [Tr. 570].
10. The Respondent testified that, although over 400,000 dosage units of oxycodone were attributable to her per the ARCOS reports, she in fact did not see all of the patients represented by this dosage number. The physician assistant saw multiple patients per day as well. [Tr. 526, 554]. Another physician was hired, and the Respondent does not know whether controlled substances purchased using the Respondent's DEA registration were actually dispensed by this physician as well. [Tr. 555]. The Respondent left that practice when her "180 program" was not being followed. [Tr. 526]. She left her DEA Form 222s at the Pain Center of Broward when she left the practice. [Tr. 556].
11. When asked if "any time an order was placed using your DEA number, was that an order done appropriately and legitimately or for other purposes," the Respondent replied that she was not sure. Specifically, she stated that the DEA Form 222s she signed "were done appropriately and legitimately, but if my former employer went and ordered stuff and signed my name to it, I had no knowledge or concept that it was being done." [Tr. 574-75]. It's possible that some of the over 400,000 dosage units were ordered without the Respondent's knowledge. [Tr. 575].
12. The Respondent primarily wrote prescriptions using a computer. However, she did have prescription pads, and it was possible that such a pad was outside her control on the day the search and seizure warrant was executed, although she did not intentionally leave such a pad outside her control. [Tr. 557]. The Respondent was a dispensing physician. [Tr. 210, 237, 341, 346-47, 362].
13. A pain management clinic would dispense a large number of oxycodone
14. Dr. Danton developed a treatment program she described as the "180 program." [Tr. 402]. The essential point of the 180 program was to help patients control their pain without developing tolerance to the pain medication and to keep the patient safe from a drug overdose. [Tr. 402]. To her knowledge, Dr. Danton is the only physician who limits oxycodone prescriptions to 180 dosage units of 15 mg oxycodone. [Tr. 403]. However, depending on the patient's pain level and the diagnosis, the Respondent would sometimes prescribe 30 mg oxycodone. [Tr. 403].
15. Dr. Danton described a bulging disc as a disc between vertebrae in the back that acts as a gel-filled shock absorber. After a high velocity injury, the gel begins to thin out and form a bulge of the disc material outward, pressing on the nerve roots, causing pain. [Tr. 406-09].
16. Dr. Danton described a herniated disc as a disc where the gel actually cracked out of the disc and escapes into a very small space in the spine, causing more pressure on the nerve roots, thus causing more pain. [Tr. 410]. The added pressure can also cause inflammation, which causes swelling around the nerve roots, making the pain worse as well. [Tr. 410-11].
17. Scoliosis is an abnormal curvature of the spine and can cause pain. [Tr. 417-19]. The nerve roots in the back become impinged and inflammation around the nerve roots results which causes the pain. [Tr. 419]. Scoliosis comes in degrees, and the severity of the scoliosis impacts upon the severity of the pain. [Tr. 419-20]. If a patient elects not to have surgery, then the appropriate treatment is pain management with analgesics. [Tr. 420].
18. To diagnose and treat scoliosis, Dr. Danton would ask about the patient's history, to determine whether the scoliosis was developmental and to find out what kind of past treatment the patient has experienced. [Tr. 421]. A prior physician would have prescribed an MRI, and the patient would bring that MRI report for Dr. Danton to review. [Tr. 421-23]. Unlike an X-ray, an MRI shows soft tissue changes such as impingement of nerves caused by a herniation of a disc. [Tr. 423-24].
19. To determine if a patient has either a bulging disc or a herniated disc, the Respondent listens to the level of the patient's complaint, looks at the medical history forms, and evaluates how the patient moves into the treatment room, watching how the patient walks and sits as part of the physical examination. [Tr. 412-13]. Next, Dr. Danton would look at a purely objective evaluation, such as an MRI. [Tr. 414]. She is also evaluating the consistencies of the MRI with the patient's complaint, and looking to see if the patient is honest and truthful. [Tr. 414]. Patients who are not honest and truthful tend to exaggerate their pain levels, so that their complaints do not match up with their MRI results. [Tr. 415-16]. The Respondent also testified that when patients subjectively rated their pain level, she interpreted that rating to mean their pain level with medication. Therefore, if a patient rated his pain at 2, then she interpreted the patient's pain to be at a level 7 without pain medication. [Tr. 469-70].
20. According to Dr. Danton, a physical examination does not necessarily "entail touching the body." [Tr. 425]. For example, in the chronic injury "you can't see--whether you're putting your hands on the patient or not, you can't see that evidence of chronic inflammation and disease by visual inspection or palpation." [Tr. 428]. But the physician can inspect the painful area, can get an idea of the pain by watching the patient move the body, which is also a part of the physical examination. [Tr. 428-29]. Although different now, in early 2010, the physician also needed to get a urinalysis test within the first four to six months of treatment with oxycodone. [Tr. 429].
21. The Respondent prescribed 2 mg tablets of Xanax or alprazolam. She described this as a moderate dose, and she instructed her patients to take .5 mg during the day, .5 mg in the evening, and 1 mg at night. If the patient stops taking Xanax in these quantities, there would be no adverse side effects. [Tr. 535].
22. The Respondent was aware that a complete medical history and physical examination must be conducted and noted in a patient's medical file. [Tr. 557].
23. The Respondent has been convicted of four counts of mail fraud, but the record contains no information that this conviction entailed the handling of controlled substances. [Tr. 560].
24. The Respondent is neither a DATA-waived physician nor registered as a Narcotics Treatment Program. [Tr. at 533]. The Respondent denied providing her patients with detoxification services. [Tr. 533]. However, she did see her role as "to educate patients how to take medicine safely and how to safely get off, away from the narcotics. That was my goal." [Tr. 581]. She also stated her goal was to have patients functioning at "100%." [Tr. 500]. The Respondent is also not registered as a pain management clinic with the Florida Department of Health. [Tr. 185].
25. Mr. Gordon Berman worked with the Respondent as the primary administrator of her practice. He owned the building. [Tr. 163].
26. Mr. Berman told DEA personnel that he was aware of the State law which had come into effect on October 1, 2010, providing that only a 72 hour supply of medication could be dispensed. [Tr. 185]. However, in November of 2010, he had dispensed 180 oxycodone 30 mg., a one-month supply. [Govt. Exh. 2 at 4-6; Tr. 185]. He stated that he knew of the limitations, but that he had just dispensed the entire amount. [Tr. 185].
27. Mr. Berman had told DEA personnel that every patient basically received the same thing; 180 oxycodone 30 mg., Xanax, Ibuprofen, and Soma. [Tr. 185-86;
28. The Respondent accepted cash as a form of payment. It is unclear whether this was the sole form of payment accepted. The Respondent stated to DI McRae that to accept insurance would require a billing department, and that would cost a lot. [Tr. 165-66]. Further, a Diversion Investigator overheard the receptionist tell a patient that the clinic only accepted cash. [Tr. 226-7]. However, Mr. Berman stated that the practice also accepted Medicaid and Medicare. [Tr. 184]. The office visit cost $200.00,
29. Mr. Berman had a nine-year-old daughter who would sometimes come to the office after school. When Ms. Hall saw Mr. Berman and his daughter walking in the hallway, Mr. Berman said that his daughter was a good little helper, and that he had her counting pills.
30. The Respondent's job was patient care, making sure the patients were appropriately treated. The Respondent also managed the front office. [Tr. 505]. The Respondent told DI McRae that she saw between 25 and 50 patients a day. [Tr. 166]. She had told DI McRae that she did not dispense controlled substances on the first visit of a patient. [Tr. 167].
31. Another physician in the practice, Dr. Jacobs, is also practicing the Respondent's "180 program." [Tr. 592].
32. The Respondent acknowledged that the medications were ordered under her DEA registration number and that she took full responsibility for them. [Tr. 506, 516]. Yet she acknowledged that she gave people authority to take certain actions using her registration. [Tr. 507]. She stated that to the best of her knowledge "we were doing everything that we thought" was within the law. [Tr. 507]. There was no power of attorney on file affording Mr. Berman with the authority to sign the order forms for the controlled substances. [Tr. 163].
33. When the Respondent became aware of discrepancies, she made corrections. She learned that her pain patients could be manipulative, and she "became a little harder and a little more careful in how" she responded to her pain patients. [Tr. 508-09].
34. The Respondent's office was burglarized four times, and her computer systems with all the backups were stolen. [Tr. 515]. The computers the Respondent had on November 23, "were basically only a month old, and the information on them was basically information from a month or two." [Tr. 515]. Three of the four break-ins occurred when the Respondent had no oxycodone on the premises. But in the instances that drugs were stolen, the Respondent did not handle informing the DEA. The thefts were reported to the Sheriff's Department but not to the DEA. [Tr. 122-23, 125, 549]. The Sherrif's Department made no mention of the Respondent's obligation to inform the DEA. [Tr. 514]. The Respondent credibly testified that she believed the Sherrif's Department would handle that responsibility. [Tr. 550]. No DEA theft and loss reports were found. [Tr. 125].
35. For security measures, the Respondent had an alarm system, video camera system, and security doors as required between the treatment area and the medication room. [Tr. 518]. The oxycodone was stored in the medication room. [Tr. 518]. Mr. Berman told the Respondent that the facility had been inspected and found to be in compliance. However, the Respondent did not know who had inspected the facility, and the record does not contain any inspection reports indicating such compliance. [Tr. 550].
36. Ms. Danielle Demers, an employee of the Respondent's, would bring her Rottweiler to the office wearing a police service dog vest. The dog was a deterrent and stayed in the administrative area of the office. [Tr. 516-17]. Ms. Demers wore a police belt with a tazer and a baton, but she did not carry a firearm in the clinic. [Tr. 517-18]. Ms. Demers was subsequently terminated from her employment. She worked for the Respondent approximately five months. [Tr. 520].
37. Ms. Demers had access to all the records in the practice, to include inventory records, DEA Form 222s, and invoices. She also had access to the computer systems. [Tr. 520-21]. She knew what security measures were in place. [Tr. 521].
38. The Respondent used two large safes behind the secured medicine room doors. One safe was for the Respondent's medications, and the other safe held the medications of Dr. Jacob.
39. The physician would prepare a charge sheet, noting the prescriptions authorized for the patient. The charge sheet would go to the pharmacy technician for filling. [Tr. 590]. [
40. The Respondent has interpreted approximately four or five thousand MRI written reports in the course of her medical practice. [Tr. 561]. In reviewing the MRI reports pertaining to the undercover individuals, the Respondent saw nothing that led her to believe the reports were fraudulent, modified or illegitimate. [Tr. 561].
41. The Respondent tried to "correspond the patient's history and their presentation with the MRI report, and in those three (undercover) cases they seem to match." [Tr. 561]. Later in her practice, the Respondent instructed her front office personnel to call and verify the MRI report. If the office staff was unable to do so, they were instructed to require the patient to take another MRI locally. [Tr. 586]. "We didn't do that in the first three months because at that point in time I was, and I accept responsibility for it, I was naive. And I believed if somebody brought in an MRI that had their name on it and the doctor's signature, that it was a real MRI. I found information to the contrary. I changed." [Tr. 586].
42. On November 23, 2010, the DEA served a Federal search warrant at the Respondent's office, as well as the Immediate Suspension Order. [Tr. 19]. The clinic had the name posted as J.A. Danton. [Tr. 47]. During the search, Group Supervisor Susan Langston discovered a closet containing video equipment and several bottles of oxycodone 30 mg, 100 count each. [Tr. 21, 112-13;
43. Also during the search, GS Langston located an empty prescription bottle with a label showing that the bottle had contained 360 Oxycodone 30 mg tablets. The bottle was found in the Respondent's office on the first floor of the facility, and the label indicated that the medication was prescribed by Dr. Jack Danton to patient Jacqueline Danton, a name the Respondent also used. [Tr. 23, 377].
44. During an interview with a local reporter, the Respondent asserted that she was not providing her patients with large quantities of oxycodone, she was weaning them off the drug. [Govt. Exh. 19].
45. GS Langston identified "red flags" from the Respondent's practice. First, she received telephone calls from pharmacists inquiring as to whether prescriptions written by the Respondent were legitimate. [Tr. 36-37, 45]. GS Langston also thought it significant that the Respondent saw a large number of people from out of state. [Tr. 45-46;
46. DI Marjorie Milan also participated in the serving of the Immediate Suspension Order. [Tr. 68]. Her assignment was to collect any controlled substances that were on the premises. [Tr. 69]. DI Milan found bottles of oxycodone 30 mg. She found a total of 4,000 pills. [Tr. 69-70].
47. DI Milan ran an ARCOS
48. DI Milan used the ARCOS information to identify the suppliers of oxycodone to the Respondent. [Tr. 73]. She then contacted the suppliers and received copies of the DEA Form 222 and invoices for the purchases made to the Respondent from Paragon Enterprises, Inc., Dispensing Solutions, Sunrise Wholesale, Inc., and Anda, Inc.. [Tr. 74-80; Govt. Exh. 6]. The DEA Form 222 indicates the drug shipped, the date shipped, and the quantities shipped. [Tr. 77]. The DEA Form 222s were those issued to the Respondent. [Tr. 108].
49. DI Milan also reviewed the purchase orders that were seized from the Respondent during the execution of the search warrant. [Tr. 81-82; Govt. Exh. 7].
50. DI Milan conducted an audit of oxycodone products from the beginning of business on December 1, 2009, through the close of business on November 23, 2010. [Tr. 87-88; Govt. Exh. 1]. DI Milan did not find an initial inventory in the records that were seized, so the beginning inventory amounts were recorded as "0". The computation chart is as follows:
[Tr. 87-90; Govt. Exh. 1]. The Respondent was unable to account for a shortage of 99,723 dosage units of oxycodone 30 mg, and a shortage of 9,460 dosage units of oxycodone 15 mg tablets. [Govt. Exh. 1]. Only the Respondent's DEA registration was used to compute the audit figures. It is unclear in the record whether Dr. Jacobs' DEA number was ever used to order controlled substances. [Tr. 190-91].
51. In looking at the prescriptions, DI Milan discovered that a number of the prescriptions did not have the required dispensing labels on the back of the prescriptions. [Tr. 97]. Further, a number of the paper copies of DEA Form 222s failed to have the received column and the date column properly completed. [Tr. 121-23; Govt. Exh. 7]. A power of attorney from the Respondent authorizing another to act on her behalf in filling out the DEA Form 222 was not found during the search of the Respondent's premises. [Tr. 122].
52. DI McRae interviewed a patient from Kentucky. He had heard about the
53. GS Langston interviewed some of the Respondent's patients. She interviewed a lady, D. L., who admitted that day to having taken 5 oxycodone 30 mg tablets. GS Langston observed that this woman was "highly under the influence" of the medication. [Tr. 25, 44]. The woman was one of three people from Kentucky, and she had seen the Respondent the day before. The lady had received 180 oxycodone 30 mg. tablets. GS Langston saw the pill bottle, and credibly testified that there were at least twenty pills missing. [Tr. 26]. The lady's husband was to see the Respondent that day, and the third person, the lady could not remember her name, was waiting to join them for the return trip to Kentucky. [Tr. 25].
54. Also during the March 2010 visit, Ms. Hall talked with two individuals from Kentucky. One of the individuals explained that the doctor would not give him 180 30 mg. pills, but he would give the man 360 15 milligram pills. [Tr. 218].
55. Task Force Officer ("TFO") Thomas interviewed patients of the Respondent in August of 2010. [Tr. 128]. The patients were from Ohio, and they stated that they could not get the quantity of oxycodone in Ohio that they could get in Florida. They had heard of the Respondent's practice through word of mouth in Ohio. [Tr. 128-29]. They first started seeing the Respondent in June of 2010, when they received 180 dosage units of 30 mg oxycodone, some Soma, Xanax, and Ibuprofen. [Tr. 129]. The doctor and the patients talked about pain levels and locations of pain, but no physical examination or range of motion testing was conducted. [Tr. 129]. The encounter lasted probably less than ten minutes. [Tr. 129]. The same procedures were used on the second and third visits. During the first two visits, the patients were dispensed medication from the clinic, but on the third visit, the patients received prescriptions because the clinic had just moved to a new location, and the dispensary had not been set up yet. [Tr. 129-30].
56. At the time Dr. Danton treated the undercover personnel, it was not a requirement to conduct a urinalysis or a blood test prior to treating a pain patient. [Tr. 429-30]. Effective November 8, 2010, the law changed and required the physician to order a urinalysis before being allowed to prescribe controlled substances. [Tr. 430-31, 577-79; Fla. Admin. Code r. 64B15-14.0051(2)(f) (2010)]. The urinalysis will determine whether or not the patient is taking the prescribed controlled substances, and whether or not the patient ingested illicit drugs. [Tr. 596]. If a patient is found to have taken illicit drugs, the physician is to discharge that patient from the doctor's practice. [Tr. 431]. On the day of the search warrant, November 23, 2010, DI McRae noted that she was told that the Respondent had run out of urinalysis kits, and no such tests had been taken for the past three days. [Tr. 168].
57. Sometimes the Respondent saw patients in a group. She would explain her "180 program," and if the patients did not object, she would review each person's MRI and fill out the drug order form for that patient in the group setting. Sometimes she would have as many as a dozen people sitting through this process. [Tr. 168-69]. If a patient wanted to be seen one-on-one, the Respondent would accommodate that request. [Tr. 186, 169].
58. The Respondent did not refer any of her patients out to other doctors. [Tr. 169].
59. During follow-up visits, the Respondent did not ask any of the undercover individuals how many oxycodone, Xanax, or Soma they had left from their previous prescriptions. [Tr. 537]. However, if the patient did not have to take any medication for break-through pain, the Respondent would lower the quantity of medication prescribed to that patient. [Tr. 579]. However, none of the medical charts in this record demonstrate such action. [Resp. Exh. 1-3].
60. If the Respondent's medical files had no notations regarding her observations of a patient's movements, that indicated to the Respondent that she had not observed anything inappropriate or inconsistent with the patient's complaint and diagnosis. [Tr. 543]. If the Respondent did witness suspicious conduct,
61. Per the Respondent, the majority of the patients received a prescription for oxycodone. [Tr. 548]. Previous doctors may have prescribed hydrocodone, felt uncomfortable prescribing oxycodone, and would refer the patients to a pain management clinic for further treatment. [Tr. 548-49].
62. The patient files in this record contain no medical reports or documents from prior physicians as related to the three undercover personnel. When asked if she had ordered such information, the Respondent stated that she could not recall. [Tr. 576-77; Resp. Exh. 1-3].
63. On February 15, 2010, Ms. Hall visited with the Respondent, and the visit was audio-recorded. [Tr. 203; Govt. Exh. 14A
64. Ms. Hall was given paperwork to fill out, including a pain assessment form. Pain was to be rated from one to ten, and Ms. Hall rated her pain at a level 3. [Tr. 207; Resp. Exh. 1]. Ms. Hall signed a document stating "there will be no exception to [the rule that the maximum amount of 2.0 mg Xanax should be no more than 60 tablets in a 28 day cycle], so please do not ask the doctor to make an exception for you." [Resp. Exh. 1 at 8]. In addition, Ms. Hall signed documents consenting to be drug screened and acknowledging that a positive test result "disclosing the prescence of an illegal substances no prescribed my [sic] any physician associated with Boca Pain and Wellness, will result in immediate termination as a patient * * *." [Respt. Exh. 1 at 9, 10]. Further, Ms. Hall signed a document stating that "lost, stolen or misplaced narcotics will not be replaced" and another form documenting that it is a third degree felony under Florida law to possess or attempt to possess a controlled substance by fraud." [Respt. Exh. 1 at 11, 12].
65. Ms. Hall was directed to sit in a chair across the desk from the Respondent. [Tr. 208]. She was not required to provide a urine sample during the visit. [Tr. 208]. Ms. Hall stated that she did not receive a physical examination. [Tr. 208]. Ms. Hall told the Respondent that she had used Vicodin before. However, she did not tell the Respondent that she was currently using Vicodin or any other controlled substances. [Tr. 209]. The
66. Ms. Hall complained of neck and shoulder pain. [Resp. Exh. 1 at 6]. Her MRI report stated that the bottom of her spine had evidence of thinning of the disc. [Tr. 444; Resp. Exh. 1]. Under impressions, the MRI reported mild spondylosis, which means that there was some slippage of one vertebra onto another, which can cause pressure on the spine. [Tr. 444; Resp. Exh. 1]. Such spondylosis may cause "a chronic impingement of that nerve" which would cause chronic pain. [Tr. 445]. Such an MRI impression was "more significant than the patient's description of their pain levels because * * * patients tend to under-exaggerate or over-exaggerate their symptoms." [Tr. 445].
67. Ms. Hall told the Respondent that she had had an automobile accident in 1999 and in 2003, and she had slipped and fallen on the ice in December of 2009, [Govt. Exh. 14B at 9], which could have aggravated her spinal condition. [Tr. 446-47; 245; 612]. She also had an accident where a box of chicken tenders had fallen on her while she worked in a cafeteria. [Tr. 245; Govt. Exh. 14B]. The Respondent noted that the injury in 1999 could have resulted in osteophytes and slippage, and the slip and fall on the ice could have aggravated the situation, as well as the accident resulting in the box of chicken tenders falling on the patient. [Tr. 246, 447].
68. The MRI also noted disc osteophytes, which are bony protrusions on the discs that develop over time. [Tr. 446, 452]. The osteophytes were consistent with Ms. Hall's history of having been in accidents in 1999 and 2003. [Tr. at 446-447]. Osteophytes indicate that the injuries were chronic. [Tr. 451]. Ms. Hall's MRI showed more damage to her spine than the MRIs for Mr. Castillo and Mr. Swanson. [Tr. 542-43]. The Respondent further found that "[i]t had more extensive damage, but the extent of the extensive damage I didn't consider warranted increasing the medication beyond the starting dose of 15 milligrams." [Tr. 563].
69. The Respondent did not find that the MRI was suspicious, in that it did not look fraudulent, modified or illegitimate. [Tr. 561]. Specifically, the Respondent was able to correspond the patient's history and her presentation with her MRI report. [Tr. 561]. The MRI report stated that it was conducted at Ingalls Memorial Hospital in Harvey, Illinois. [Respt. Exh. 4 at 5]. The Respondent asked Ms. Hall whether she always "drove this way" from Harvey Illinois, to which the patient responded, "Well, I'm kind of back and forth; I'm thinking about moving here `cause I recently lost my jobs and I got so