19434 Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices 

1All citations to the ALJ’s Decision (ALJ) are to 

the slip opinion as issued on August 10, 2010, and 

not to the attached decision which has been 

reformatted. 

2The ALJ found that there is ‘‘no evidence that 

the Respondent ‘prescribe[d] and dispense[d] 

inordinate amounts of controlled substances.’’ ALJ 

at 26. While there is no evidence as to the amounts 

that Respondent directly dispensed, there is 

evidence, which is unrefuted, that Respondent 

prescribed inordinate amounts of controlled 

substances. In his report, an Expert witness 

explained that the usual starting dose of Xanax is 

.25 to .5 mg. once to twice per day and yet 

Respondent prescribed Xanax 2 mg. twice per day 

to patients ‘‘who had not had Xanax before or 

recently,’’ and that he did so without documenting 

that he had considered any of the possible 

underlying causes of his patients’ complaint that 

they had anxiety; moreover, Respondent did not 

refer the patients to a mental health professional. 

GX 5, at 9–10. As the Expert explained, ‘‘[t]he 

treatment was with a very high dose of the 

controlled substance Xanax. This was clearly not 

within the boundaries of professional practice.’’ Id. 

at 10. There is also unrefuted evidence that 

Respondent’s prescribing of drug cocktails of 

oxycodone and Xanax lacked a legitimate medical 

purpose. Id. at 13. In this manner, Respondent did 

prescribe inordinate amounts. 

3 I do not, however, adopt the ALJ’s discussion of 

the standards applied by the Agency in assessing 

a practitioner’s experience in dispensing controlled 

substances, which cites cases involving list 

chemical I distributors, a different category of 

registrant. See ALJ at 25–26. As the Agency has 

previously made clear, DEA can revoke based on a 

single act of intentional diversion and ‘‘evidence 

that a practitioner has treated thousands of patients’’ 

in circumstances that do not constitute diversion 

‘‘does not negate a prima facie showing that the 

practitioner has committed acts inconsistent with 

the public interest.’’ Jayam Krishna-Iyer, 74 FR 459, 

463 (2009). See also Dewey C. MacKay, 75 FR 

49956, 49977 (2010); Medicine ShoppeJonesborough, 73 FR 364, 386 & n.56 (noting that 

pharmacy ‘‘had 17,000 patients,’’ but that ‘‘[n]o 

amount of legitimate dispensings can render * * * 

flagrant violations [acts which are] ‘consistent with 

the public interest’’’), aff’d, Medicine ShoppeJonesborough v. DEA, 300 Fed. Appx. 409 (6th Cir. 

2008). As I further explained, ‘‘[w]hile such 

evidence may be [entitled to] some weight in 

assessing whether a practitioner has credibly shown 

that [he] has reformed his practices,’’ it is entitled 

to no weight where a practitioner fails to 

acknowledge his wrongdoing. Krishna-Iyer, 74 FR at 

463. 

In any event, Respondent offered no evidence on 

the issue of his experience in dispensing controlled 

substances and the ALJ’s ultimate conclusions that 

Respondent violated the CSA’s prescription 

requirement because he dispensed controlled 

substance prescriptions that were not ‘‘within ‘the 

usual course of [his] professional practice,’’’ ALJ at 

39 (quoting 21 CFR 1306.04(a)), and that ‘‘the 

evidence under the [experience] * * * factor[] 

support[s]’’ the revocation of his registration, is 

consistent with Agency precedent. Id. 

With respect to factor five, ‘‘[s]uch other conduct 

which may threaten public health and safety,’’ 21 

U.S.C. 823(f)(5), the ALJ opined that ‘‘an adverse 

finding under this factor requires some showing 

that the relevant conduct actually constituted a 

Respondent’s counsel, or any other lay 

source would be a dangerous course and 

more importantly, a plainly erroneous 

one. 

Accordingly, after carefully balancing 

the admitted evidence, the evidence 

establishes, by a preponderance of the 

evidence, that the prescriptions the 

Respondent issued in Florida were not 

issued within ‘‘the usual course of [the 

Respondent’s] professional practice.’’ 21 

CFR 1306.04(a). Consideration of the 

evidence under the second and fourth 

factors support the COR revocation 

sought by the Government in this case. 

To the extent that the Respondent’s 

prescribing practices fell below the 

requisite standard in Florida, that 

conduct also impacts upon the Fifth 

statutory factor. Under Factor 5, the 

Deputy Administrator is authorized to 

consider ‘‘other conduct which may 

threaten the public health and safety.’’ 

21 U.S.C. 823(f)(5). Although this factor 

authorizes consideration of a somewhat 

broader range of conduct reaching 

beyond those activities typically 

associated with a registrant’s practice, 

an adverse finding under this factor 

requires some showing that the relevant 

conduct actually constituted a threat to 

public safety. See Holloway Distrib., 72 

FR 42118, 42126 (2007). 

The evidence establishes that the 

Respondent engaged in a course of 

practice wherein he prescribed unsafely 

high doses of controlled substances to 

patients irrespective of the patients’ 

need for such medication and ignoring 

any and red flags that could or did 

indicate likely paths of diversion. The 

testimony of Dr. Kennedy, the DEA 

regulations, and the Florida Standards 

make clear that physicians prescribing 

controlled substances do so under an 

obligation to monitor the process to 

minimize the risk of diversion. The 

patient charts reflect that the 

Respondent, contrary to his obligations 

as a DEA registrant, did not follow up 

in the face of multiple red flags. The 

Respondent’s disregard of his 

obligations as a DEA registrant and 

Federal and State laws related to 

controlled substances militate in favor 

of revocation. 

By routinely prescribing unsafely high 

doses of controlled substances to 

opioid-naı ̈ve patients and ignoring his 

responsibilities to monitor the 

controlled substance prescriptions he 

was authorizing to minimize diversion, 

and by participating in an insufficiently 

documented and thoughtful process for 

the issuance of potentially dangerous 

controlled substances, the Respondent 

created a significant potential conduit 

for the unchecked diversion of 

controlled substances. See Holloway 

Distrib., 72 FR at 42124 (a policy of ‘‘see 

no evil, hear no evil’’ is fundamentally 

inconsistent with the obligations of a 

DEA registrant). Agency precedent has 

long recognized that ‘‘[l]egally, there is 

absolutely no difference between the 

sale of an illicit drug on the street and 

the illicit dispensing of a licit drug by 

means of a physician’s prescription.’’ 

EZRX, LLC, 69 FR 63178, 63181 (1988); 

Floyd A. Santner, M.D., 55 FR 37581 

(1988). 

Agency precedent has consistently 

held that where, as here, the 

Government has met its burden to 

establish a prima facie case that a 

registrant has committed acts 

demonstrating that continued 

registration is inconsistent with the 

public interest, acceptance of 

responsibility is a condition precedent 

to continued registration. Jeri Hassman, 

M.D., 75 FR 8194, 8236 (2010); Medicine 

Shoppe, 73 FR at 387. The record 

contains no evidence that the 

Respondent has either acknowledged or 

accepted responsibility for the 

misconduct at issue in these 

proceedings. 

Recommendation 

Based on the foregoing, the evidence 

supports a finding that the Government 

has established that the Respondent has 

committed acts that are inconsistent 

with the public interest. A balancing of 

the statutory public interest factors 

supports the revocation of the 

Respondent’s Certificate of Registration 

and a denial of his application to renew. 

The Respondent has not accepted 

responsibility for his actions, expressed 

remorse for his conduct at any level, or 

presented evidence that could 

reasonably support a finding that the 

Deputy Administrator should continue 

to entrust him with a Certificate of 

Registration. 

Accordingly, the Respondent’s 

Certificate of Registration should be 

revoked and any pending applications 

for renewal should be denied. 

Dated: August 10, 2010. 

John J. Mulrooney, II, 

U.S. Administrative Law Judge. 

[FR Doc. 2011–8348 Filed 4–6–11; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 10–37] 

Roni Dreszer, M.D.; Decision and Order 

On August 10, 2010, Administrative 

Law Judge (ALJ) John J. Mulrooney, II, 

issued the attached recommended 

decision.1 Thereafter, Respondent filed 

exceptions to the decision. 

Having reviewed the entire record 

including the ALJ’s recommended 

decision and Respondent’s exceptions, I 

have decided to adopt the ALJ’s rulings, 

findings of fact,2 conclusions of law,3

and recommended Order. 

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Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices 19435 

threat to public safety.’’ ALJ at 39 (emphasis added). 

Contrary to the ALJ’s reasoning, Congress, by 

inserting the word ‘‘may’’ in factor five, clearly 

manifested its intent to grant the Agency authority 

to consider conduct which creates a probable or 

possible threat (and not only an actual) threat to 

public health and safety. See Webster’s Third New 

Int’l Dictionary 1396 (1976) (defining ‘‘may’’ in 

relevant part as to ‘‘be in some degree likely to’’); 

see also The Random House Dictionary of the 

English Language 1189 (1987) (defining ‘‘may’’ in 

relevant part as ‘‘used to express possibility’’). While 

the ALJ misstated the applicable standard, his 

conclusion that Respondent repeatedly ignored ‘‘red 

flags’’ indicative of likely diversion and thus 

‘‘created a significant potential conduit for the 

unchecked diversion of controlled substances,’’ ALJ 

at 39, is clearly supported by substantial evidence 

and warrants an adverse finding under factor five. 

The ALJ also opined that ‘‘[i]t is clear that in 

assessing whether the controlled substance 

prescribing practices of a Florida practitioner fall 

within the acceptable range of what constitutes 

being within the bounds of being ‘issued for a 

legitimate medical purpose by an individual 

practitioner acting in the usual course of his 

professional practice,’ resort must be had to an 

expert.’’ ALJ at 34 (quoting 21 CFR 1306.04(a)). 

While the ALJ properly noted the importance of 

expert testimony in this case, in which the 

Government primarily relied on a review of the 

medical charts, whether expert testimony is needed 

in any case necessarily depends on the nature of the 

allegations and the other evidence in the case. 

Where, for example, the Government produces 

evidence of undercover visits showing that a 

physician knowingly engaged in outright drug 

deals, expert testimony adds little to the proof 

necessary to establish a violation of Federal law. 

4He also co-edited and contributed to the State 

of Kentucky’s Guidelines for Prescribing Controlled 

Substances, 2nd Edition. GX 117, at 9. 

5Consistent with DEA’s longstanding precedent, 

see ALJ at 19, a respondent is also entitled to put 

on evidence as to his acceptance of responsibility 

and any remedial measures he has undertaken to 

prevent the re-occurrence of similar acts. 

Respondent first takes exception to 

the ALJ’s acceptance of L. Douglas 

Kennedy, M.D., as an expert on the 

proper prescribing of controlled 

substances. Respondent contends that 

Dr. Kennedy should not have been 

permitted to opine on his prescribing 

practices because he does not hold a 

DEA registration in Florida, has not 

prescribed a controlled substance since 

2004, does not currently have either a 

medical office or hospital privileges in 

Florida, and ‘‘has never practiced 

medicine regularly in Florida and has 

not practiced medicine in Florida at all 

in over 10 years.’’ Resp. Exc. at 1. 

Respondent’s contention is unavailing 

as Dr. Kennedy was clearly qualified to 

render an expert opinion on the proper 

practice for prescribing controlled 

substances to treat pain and whether 

Respondent’s controlled substance 

prescriptions were issued in the usual 

course of professional practice and for a 

legitimate medical purpose. See 21 CFR 

1306.04(a). Dr. Kennedy currently holds 

a Florida medical license, is a diplomate 

of both the American Board of Pain 

Medicine and the American Board of 

Anesthesiology, and is currently on the 

faculty of the University of Miami’s 

Miller School of Medicine. GX 117, at 

1, 10. Previously, Dr. Kennedy was a 

Fellow with the Pain Therapy Unit of 

the Cleveland Clinic, served as the 

Director of Chronic Pain Management at 

the University of Kentucky Medical 

Center, and, for fourteen years, was the 

Medical Director of a multidisciplinary 

pain medicine and rehabilitation 

practice. Id. at 1–2. 

Dr. Kennedy has published several 

articles and book chapters on pain 

management issues and has made 

several dozen presentations on pain 

management issues at professional 

meetings.4 Id. at 3–7. In addition, he is 

a member of several professional 

organizations including the American 

Academy of Pain Medicine, the 

American Board of Pain Medicine, the 

American Pain Society, the 

International Association for the Study 

of Pain, the American Society of 

Addiction Medicine, the American 

Board of Anesthesiology, and the 

American Society of Anesthesiology. Id. 

at 10; Tr. 22. Finally, Dr. Kennedy 

explained that he was familiar with the 

Florida Board of Medicine’s standards 

for prescribing controlled substances to 

treat pain and that he had reviewed 

them prior to preparing his report. Tr. 

24–26; GX 101, at 6–7. 

Thus, Dr. Kennedy was clearly 

qualified to provide expert testimony. I 

therefore agree with the ALJ that Dr. 

Kennedy’s testimony was sufficiently 

reliable to constitute substantial 

evidence on the issue of whether 

Respondent acted within the usual 

course of professional practice and had 

a legitimate medical purpose in 

prescribing controlled substances to the 

patients whose files he reviewed and 

reject this exception. ALJ at 17. 

Next, Respondent contends that Dr. 

Kennedy’s opinion testimony is entitled 

to no weight because it was based on 

only sixteen patient charts, which 

Respondent maintains were not 

randomly selected and is too small a 

sample to draw sufficient conclusions 

about the validity of his prescribing 

practices. Resp. Exc. at 2. In support of 

this contention, Respondent relies on 

Dr. Kennedy’s testimony that ‘‘ ‘[i]t 

might not be fair’ ’’ to ‘‘ ‘cherry-pick[]’ ’’ 

sixteen charts out of a physician’s 

patients because those might be the ‘‘the 

only people out of 2,000’’ and that the 

problems found would ‘‘be ‘an 

administrative issue for education with 

the Board of Medical License and not’ ’’ 

necessarily justify the revocation of 

Respondent’s medical license (or DEA 

registration). Id. (quoting Tr. 612–13). 

However, even acknowledging that 

one of the sixteen files reviewed by Dr. 

Kennedy with respect to Respondent 

was not randomly selected because it 

was that of an undercover officer, the 

ALJ found credible the Diversion 

Investigator’s testimony that the files 

were not specially selected to enhance 

the strength of the Government’s case. 

ALJ at 5 (citing Tr. 768). More 

importantly, the requirement of Federal 

law that a prescription ‘‘must be issued 

for a legitimate medical purpose by an 

individual practitioner acting in the 

usual course of his professional 

practice,’’ 21 CFR 1306.04(a), applies to 

each and every prescription issued by a 

practitioner. Thus, contrary to the 

Expert’s understanding, in determining 

whether a practitioner has committed 

acts which render his ‘‘registration 

inconsistent with the public interest,’’ 

21 U.S.C. 824(a)(4), DEA is not required 

to randomly select the files which it will 

base its case on. 

For example, where the Government 

has developed information that 

particular patients are drug dealers or 

engaged in self-abuse, it is not required 

to ignore the files pertaining to these 

patients and base its case on a random 

sample of files. Rather, it can lawfully 

select the files pertaining to those 

patients and base its case entirely on 

them. Moreover, where the Government 

has seized files, it can review them and 

choose to present at the hearing only 

those files which evidence a 

practitioner’s most egregious acts. Of 

course, where, as here, the 

Government’s case relies so heavily on 

a chart review, the practitioner can put 

on his own evidence and argue that the 

Government’s evidence does not 

establish that he violated the 

prescription requirement or that his 

conduct was not so egregious as to 

warrant revocation. See Paul Caragine, 

63 FR 51592 (1998). See also Dewey C. 

MacKay, 75 FR at 49977; Krishna-Iyer, 

74 FR at 463 (holding that DEA can 

revoke based on a single act of 

diversion); Medicine ShoppeJonesborough, 73 FR at 386 & n.56.5

Accordingly, there is no merit to 

Respondent’s contention. 

Finally, Respondent takes exception 

to the ALJ’s findings that he violated 

Florida’s standards for prescribing 

controlled substances. Resp. Exceptions 

at 4–5. More specifically, Respondent 

contends that he complied with the 

standards set forth under Florida 

regulations and that he ‘‘took a complete 

medical history and conducted a 

physical evaluation that was 

documented,’’ that he maintained 

‘‘medical records documenting the 

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6Even after Gonzales v. Oregon, 546 U.S. 243 

(2006), multiple courts of appeals, including the 

Eleventh Circuit, ‘‘have applied a general-practice 

standard when determining whether the 

practitioner acted in the ‘usual course of 

professional practice.’ ’’ United States v. Smith, 573 

F.3d 639, 647–48 (8th Cir. 2009); see also id. at 648 

(discussing United States v. Moore, 423 U.S. 122 

(1975); ‘‘Thus informed by the Supreme Court and 

other controlling and persuasive precedent, we 

believe that it was not improper to measure the 

‘usual course of professional practice’ under 

§ 841(a)(1) and [21 CFR] 1306.04 with reference to 

generally recognized and accepted medical 

practices * * *.’’). Likewise, the Eleventh Circuit 

has held that ‘‘[t]he appropriate focus * * * rests 

upon whether the physician prescribes medicine ‘in 

accordance with a standard of medical practice 

generally recognized and accepted in the United 

States.’ ’’ United States v. Merrill, 513 F.3d 1293, 

1306 (11th Cir. 2008) (quoting Moore, 423 U.S. at 

139). 

7Of the sixteen patients, only five were from 

Florida. Of the remaining patients, five were from 

Kentucky, two were from Tennessee, and one was 

from each of the following States: North Carolina, 

Ohio, Massachusetts, and Georgia. GX 101, at 9. 

8 Dr. Kennedy explained that referring a patient 

to obtain an MRI prior to having some contact is 

unusual and medically inappropriate. Tr. 71–72. 

9While Respondent referred one patient to his 

primary care physician for jaundice, and another to 

the Emergency Room to be evaluated for cellulitis, 

according to their respective medical records, both 

of these patients went to Respondent because of 

lower back pain. See GX 108, at 9; GX 109, at 1. 

10 Dr. Kennedy explained that the urine drug 

screens did not indicate the temperature and 

specific gravity of the specimen, whether the giving 

of the sample had been observed, or the type of 

drug screen used. GX 101, at 4; Tr. 100–03. 

patient’s intensity of pain, current and 

past treatments for pain, and the effect 

of pain on physical and psychological 

function.’’ Id. at 4. He further argues that 

‘‘[h]e set out a written treatment plan, 

discussed the risks and benefits of 

controlled substances and conducted 

periodic reviews’’ as also required by 

Florida’s regulations. Id. at 4–5. 

While it is true that Dr. Kennedy 

acknowledged that he was not familiar 

with the specific standard imposed by 

the State of Florida for excessive 

prescribing and that he had not 

reviewed any Florida Medical Board 

decisions addressing the issue of what 

is an adequate medical history, see ALJ 

at 17; as noted above, in his report Dr. 

Kennedy discussed at length the Florida 

Board of Medicine’s Standards for the 

Use of Controlled Substances for the 

Treatment of Pain, Fla. Admin. Code 

64B8–9.013. See GX 101, at 6–7.6 Nor 

did Respondent produce any evidence 

that his recordkeeping and prescribing 

complied with the standards of the 

Florida Medical Board. Moreover, there 

is substantial evidence to support the 

conclusion that Respondent was not 

engaged in legitimate medical practice 

and was diverting drugs. 

As Dr. Kennedy explained, most of 

the patients were from out-of-state, with 

some travelling up to 1200 miles,7 even 

though Respondent had no specialized 

training in pain management, and yet, 

Respondent did not obtain reports from 

the prescription monitoring programs 

run by the States where his patients 

lived. Id. at 16–17. Moreover, 

Respondent did not obtain adequate 

medical histories and perform adequate 

physical examinations; he also never 

obtained medical records from other 

treating physicians (or even contacted 

them) for any of the patients whose files 

are in evidence. Id. at 14–17. 

As Dr. Kennedy explained, while 

‘‘[t]he chart was set up to give the 

appearance of a legitimate medical 

practice in an attempt to justify the 

initial and continued prescription and 

dispensing of high dose multiple 

controlled substances (‘drug cocktails’),’’ 

and that while ‘‘on the surface [the 

charts] were adequate for evaluating and 

treating a patient,’’ on closer review, 

‘‘the actual contents in the charts, 

clearly evidence[] just the opposite’’ as 

the charts ‘‘were very difficult * * * to 

read [with] many sections left blank or 

incompletely filled in.’’ Id. at 17. 

Continuing, Dr. Kennedy explained that 

‘‘[t]he notes were not within the 

standard of care; all were outside the 

boundaries of professional practice, 

lacking significant information and 

ignoring significant history that was 

present.’’ Id. Moreover, Respondent’s 

failure to obtain patients’ medical 

records ‘‘was well outside the 

boundaries of medical practice and 

below the standard of medical care,’’ 

especially for patients receiving ‘‘very 

high dose[s]’’ of controlled substances. 

Id. 

The evidence further shows that this 

case is not simply a matter of 

inadequate record keeping. While 

Respondent apparently required his 

patients to obtain an MRI, in multiple 

instances the MRI was obtained before 

the patient was even evaluated by 

Respondent, and generally, no other 

imaging studies such as x-rays or CT 

scans were done.8 Id. at 16. Moreover, 

Respondent rarely referred a patient to 

another physician or health care 

professional for a consultation.9 As Dr. 

Kennedy explained, ‘‘alternative 

opinions should have been sought in 

order to better diagnose and treat; not to 

do so was outside the boundaries of 

professional practice and not within the 

standard of care.’’ Id. Dr. Kennedy thus 

concluded that Respondent’s ‘‘diagnoses 

were usually very vague and/or without 

medical merit’’ and were done in an 

‘‘attempt[] to justify what controlled 

substances he prescribed.’’ Id. at 17. 

Dr. Kennedy further observed that 

while Respondent performed urine drug 

screens, he ignored the results even 

when they were inconsistent with other 

information provided by the patients 

such as when a patient tested positive 

for controlled substances which he had 

previously indicated that he was not 

currently taking. Id. at 14–15; ALJ at 15– 

16. Moreover, the drug screens were 

rarely performed other than at the 

patient’s initial visit and lacked quality 

controls.10 GX 101, at 15. 

Also, although the charts indicate that 

Respondent discussed doing yoga and 

stretching, using an anti-inflammatory 

diet, and taking several over-the-counter 

supplements (fish oil and glucosamine 

chondroitin), Respondent’s treatment 

plan primarily involved prescribing 

‘‘drug cocktails’’ of high doses of 

controlled substances with the same 

regimen of drugs (typically two 

strengths of oxycodone immediate 

release and Xanax) prescribed in nearly 

every case. Id. at 5, 13, 15. Most 

significantly, Respondent never referred 

any of the sixteen patients for 

consultations with specialists related to 

their pain complaints, or for physical, 

occupational or mental health therapy. 

GX 101, at 13. 

Dr. Kennedy further observed that 

while the typical starting dose of Xanax 

is 0.25 to 0.5 mg., once to twice per day, 

Respondent prescribed Xanax 2 mg., 

once or twice per day to fourteen of the 

sixteen patients, and he did so even 

with patients who had not been on the 

drug either ‘‘before or recently’’ and ‘‘no 

matter the age or clinical situation.’’ Id. 

While Xanax is used as an anti-anxiety 

agent, Respondent’s medical records did 

not support the prescribings because 

‘‘[h]e did not list important factors that 

could cause anxiety * * * such as 

depression, life stressors, psychosocial 

situation, caffeine intake, sleep 

disturbance [and a] previous medical 

evaluation’’; he also did not refer these 

patients for evaluation by a mental 

health professional. Id. And with 

respect to J.S., Dr. Kennedy concluded 

that Respondent’s prescribing of this 

very high dose of Xanax ‘‘was clearly not 

within the boundaries of professional 

practice.’’ Id. 

Finally, Dr. Kennedy noted that 

beginning with a patient’s first visit, 

Respondent prescribed very high initial 

doses of oxycodone. Dr. Kennedy 

explained that the usual starting dose 

for an opioid naı ̈ve patient in moderate 

to severe pain was five milligrams of 

oxycodone taken every four hours as 

needed for a total of thirty milligrams 

per day. Id. at 9. Yet at J.S.’s first visit, 

Respondent prescribed (in addition to 

60 Xanax), 180 Roxicodone 30 mg. (with 

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11Pursuant to an order issued on April 15, 2010, 

with the consent of the Respondent, the hearing in 

this matter was consolidated with the cases of four 

other registrants who were working at the same 

clinic as the Respondent and who were also issued 

OSC/ISOs on February 25, 2010, alleging similar 

and related conduct. 

12A schedule II controlled substance. 

13The majority of which are supported by no 

evidence introduced by the Government during the 

course of these proceedings. 

14A schedule IV controlled substance. 

one tablet to be taken every four hours), 

as well as sixty Roxicodone 15 mg. (one 

tablet, twice a day, as needed for pain), 

an amount that is seven times the usual 

starting dose. Id. at 19. While J.S. had 

noted on his medication contract that 

three months earlier, he had been 

prescribed 210 oxycodone 30 mg., 90 

oxycodone 15 mg., and 90 Xanax 2mg., 

which was ‘‘almost exactly what 

[Respondent] prescribed[,]’’ Respondent 

did not identify the name of the 

physician who had issued the 

prescriptions and did not attempt to 

confirm them. Id. at 11. 

At each of J.S.’s subsequent visits, 

Respondent prescribed an additional 

thirty tablets of oxycodone 30 mg. (for 

a total of 210), along with sixty tablets 

of oxycodone 15 mg. and 60 tablets of 

Xanax 2 mg. Id. at 19. While Dr. 

Kennedy acknowledged that prescribing 

an additional strength of oxycodone 

could be legitimate if it was done to 

treat breakthrough or episodic pain on 

an as-needed basis, with respect to J.S., 

who received prescriptions for 

oxycodone 30 mg. and 15 mg., ‘‘there 

was no specific reason stated in the 

medical record’’ for prescribing both 

drugs. Id. at 12. And with respect to all 

of the patients whose files he reviewed, 

Dr. Kennedy explained that 

Respondent’s prescribing of drug 

cocktails of ‘‘a very high dose opioid’’ 

(including two forms of oxycodone) and 

a ‘‘high dose * * * benzodiazepine’’ 

(Xanax) lacked ‘‘any legitimate medical 

purpose.’’ Id. at 15. 

As Dr. Kennedy concluded, 

Respondent ‘‘was not engaged in the 

practice of medicine,’’ and ‘‘[t]he vast 

majority of [his] prescriptions for 

controlled substances was not for a 

legitimate medical purpose and w[as] 

beyond the boundaries of professional 

practice.’’ Id. at 18. His ‘‘routine and 

excessive prescription of multiple 

controlled substances * * * and lack of 

arriving at a valid medical diagnosis and 

treatment most likely caused harm to 

the patients he saw as well as * * * to 

other people in their communities.’’ Id. 

I thus reject this exception as well. 

Finally, I also reject Respondent’s 

exception to the ALJ’s ultimate finding 

that Respondent has committed acts 

which render his registration 

inconsistent with the public interest. 

Resp. Exc. 5. Because the record 

establishes that Respondent has 

repeatedly violated Federal law by 

issuing controlled substance 

prescriptions which lacked a legitimate 

medical purpose and were issued 

outside of the usual course of 

professional practice, 21 CFR 1306.04, 

and Respondent has offered no evidence 

establishing that he has accepted 

responsibility for his misconduct and 

that he has reformed his practice, see 

Steven M. Abbadessa, 74 FR 10077, 

10081 (2009), I adopt the ALJ’s 

recommendation that Respondent’s 

registration be revoked. 

Order 

Pursuant to the authority vested in me 

by 21 U.S.C. 823(f) and 824(a), as well 

as 21 CFR 0.100(b) and 0.104, I order 

that DEA Certificate of Registration, 

FD1201196, issued to Roni Dreszer, 

M.D., be, and it hereby is, revoked. I 

further order that any pending 

application of Roni Dreszer, M.D., to 

renew or modify his registration, be, and 

it hereby is, denied. This Order is 

effective immediately. 

Dated: March 31, 2011. 

Michele M. Leonhart, 

Administrator. 

Larry P. Cote., Esq., for the Government 

Sean M. Ellsworth., Esq., for the 

Respondent 

Recommended Rulings, Findings of 

Fact, Conclusions of Law, and Decision 

of the Administrative Law Judge 

John J. Mulrooney, II, Administrative 

Law Judge. On February 25, 2010, the 

Deputy Administrator, Drug 

Enforcement Administration (DEA or 

Government), issued an Order to Show 

Cause and Immediate Suspension of 

Registration (OSC/ISO), immediately 

suspending the DEA Certificate of 

Registration (COR), Number FD1201196, 

of Roni Dreszer, M.D. (Respondent), as 

a practitioner, pursuant to 21 U.S.C. 

824(d), alleging that such registration 

constitutes an imminent danger to the 

public health and safety. The OSC/ISO 

also sought revocation of the 

Respondent’s registration, pursuant to 

21 U.S.C. 824(a)(4), and denial of any 

pending applications for renewal or 

modification of such registration, 

pursuant to 21 U.S.C. 823(f), alleging 

that the Respondent’s continued 

registration is inconsistent with the 

public interest, as that term is used in 

21 U.S.C. 823(f). On March 22, 2010, the 

Respondent timely requested a hearing, 

which, pursuant to a change of venue 

granted at his request was conducted in 

Miami, Florida, on July 7, 2010 through 

July 9, 2010.11 The immediate 

suspension of the Respondent’s COR 

has remained in effect throughout these 

proceedings. 

The issue ultimately to be adjudicated 

by the Deputy Administrator, with the 

assistance of this recommended 

decision, is whether the record as a 

whole establishes by substantial 

evidence that Respondent’s registration 

with the DEA should be revoked as 

inconsistent with the public interest as 

that term is used in 21 U.S.C. 823(f) and 

824(a)(4). The Respondent’s DEA 

practitioner registration expires by its 

terms on June 30, 2011. 

After carefully considering the 

testimony elicited at the hearing, the 

admitted exhibits, the arguments of 

counsel, and the record as a whole, I 

have set forth my recommended 

findings of fact and conclusions below. 

The Evidence 

The OSC/ISO issued by the 

Government alleges that the 

Respondent, through the medical 

practice he participated in at American 

Pain, LLC (American Pain), prescribed 

and dispensed inordinate amounts of 

controlled substances, primarily 

oxycodone,12 under circumstances 

where he knew, or should have known, 

that the prescriptions were not 

dispensed for a legitimate medical 

purpose. ALJ Ex. 1. The OSC/ISO 

further charges that these prescriptions 

were issued outside the usual course of 

professional practice based on a variety 

of circumstances 13 surrounding the 

manner in which American Pain is 

operated and the manner in which its 

physicians, including Respondent, 

engaged in the practice of medicine. Id. 

Respondent is also alleged to have 

provided undercover law enforcement 

personnel with controlled substances, 

including, inter alia, oxycodone and 

alprazolam,14 after cursory or no 

medical examinations, and therefore 

without a legitimate medical purpose. 

Id. The Government also alleges that 

Respondent’s former patients have 

apprised law enforcement personnel 

that ‘‘they were able to obtain 

prescriptions for controlled substances 

from [the Respondent] for other than a 

legitimate medical purpose and with the 

intention of selling the controlled 

substances and/or personally abusing 

the drugs.’’ Id. 

At the hearing, the Government 

presented the testimony of three 

witnesses, DEA Miami Field Division 

(MFD) Group Supervisor (GS) Susan 

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15Although GS Langston testified that DEA 

immediately suspended the COR that had been 

issued to Boca Drugs, Tr. at 715, and that a 

voluntary surrender by that registrant followed a 

day later, id. at 776, no evidence has been presented 

that would lend that fact any particular significance 

related to any issue that must or should be found 

regarding the disposition of the present case. 

16 GS Langston testified that she was unaware of 

the location of the closest Walgreens to American 

Pain’s offices. Tr. at 779. No evidence was 

presented that would tend to establish that any 

Walgreens or any other pharmacy has taken a 

position regarding its willingness to fill 

prescriptions authorized by American Pain. 

17Although GS Langston testified that she did not 

actually take the photographs taken during the 

search warrant execution at American Pain, she did 

provide sufficient, competent evidence to support 

the admission of the photographs that were 

ultimately received into evidence. Tr. at 737, 739– 

41. 

18Remarkably, although this unfortunate aspect 

of this document was brought to light during the 

course of the hearing, Tr. at 732, no effort on the 

part of the Government was made to provide 

additional details or explanation that might tend to 

differentiate between the respondents. 

Langston, DEA Special Agent (SA) 

Michael Burt, and L. Douglas Kennedy, 

M.D., D.A.B.P.M., Affiliate Clinical 

Assistant Professor at the University of 

Miami, Miller School of Medicine. 

GS Langston testified that the 

investigation of the American Pain 

Clinic had its origins on November 30, 

2009, during a routine inspection that 

she and a subordinate diversion 

investigator conducted at Appurtenance 

Biotechnology, LLC, a pharmacy doing 

business under the name Boca Drugs 

(Boca Drugs), and located a few blocks 

away from one of the former locations 

of American Pain. Tr. at 713, 717–20. 

According to Langston, an examination 

of the prescriptions seized from Boca 

Drugs revealed that the majority of those 

prescriptions were for oxycodone and 

alprazolam authorized over the 

signature of physicians associated with 

American Pain.15 Id. at 721. Under 

Langston’s supervision, DEA diversion 

investigators catalogued the 

prescriptions seized at Boca Drugs (Boca 

Drugs Prescription Log). Govt. Ex. 118. 

However, inasmuch as the Boca Drugs 

Prescription Log fails to distinguish 

between the Respondent, and another 

registrant with the same last name, the 

document is of no utility in reaching a 

disposition of the present case. 

GS Langston also testified that, on 

March 3, 2010, a criminal search 

warrant was executed on the American 

Pain Clinic simultaneously with the 

OSC/ISO that initiated the present case. 

Tr. at 735. According to Langston, the 

items seized from American Pain 

included a sign that had been posted in 

what she believes to have served as the 

urinalysis waiting room. Id. at 735–37. 

The seized sign set forth the following 

guidance: 

ATTENTION PATIENTS 

Due to increased fraudulent prescriptions, 

[i]t’s best if you fill your medication in 

Florida or your regular pharmacy. Don’t go to 

a pharmacy in Ohio when you live in 

Kentucky and had the scripts written in 

Florida. The police will confiscate your 

scripts and hold them while they investigate. 

This will take up to 6 months. So only fill 

your meds in Florida or a pharmacy that you 

have been using for at least 3 months or 

more. 

Govt. Ex. 119 at 1. This sign is attached, 

apparently by some sort of tape, to the 

top portion of two other signs, posted at 

the same location, the first of which 

reads: 

ATTENTION: 

Patients 

Please do NOT fill your prescriptions at 

any WALGREENS PHARMACY 16 or 

OUTSIDE the STATE OF FLORIDA. 

Id. The final attachment to the 

composite sign bears the words ‘‘24 

Hour Camera Surveillance.’’ 

Id. A photograph of the composite sign 

was admitted into evidence. 

Langston also testified that while she 

was present in the American Pain 

offices, she noticed that each 

physician’s desk was equipped with a 

group of stamps, each of which depicted 

a controlled substance medication with 

a corresponding medication usage 

instruction (sig). Tr. at 738–39. A 

photograph of one set of prescription 

script stamps was admitted as an 

exhibit.17 Govt. Ex. 119 at 2. 

GS Langston also testified that a great 

number of medical charts were seized 

from the American Pain offices, and that 

she and her staff selected a number of 

these files to be analyzed by a medical 

expert procured by the Government. Tr. 

at 762. According to GS Langston, after 

the execution of the warrant, the charts 

from the entire office were placed into 

piles in alphabetical order, and not 

separated by physician. Langston 

testified that she and three of her 

diversion investigators reviewed the 

seized files with a view towards 

choosing approximately fifteen files for 

each doctor with the aspirational 

criteria that each would reflect at least 

three to four visits by that doctor with 

a patient. Each investigator was 

empowered to place a chart on the 

selected pile, and when the target 

number (or about that number) was 

reached for each physician, the 

selection effort relative to that physician 

was deemed accomplished. Id. at 765. 

Langston credibly testified that there 

was no effort to specially select files 

under some prosecution-enhancement 

or ‘‘cherry picking’’ purpose. Id. at 768. 

Langston also explained DEA’s 

Automated Record Consolidated 

Ordering System (ARCOS) and testified 

that she generated an ARCOS report 

relative to the Respondent’s ordering of 

controlled substances from January 2009 

through February 2010. Govt. Ex. 97. 

In the same fashion, Langston 

explained the purposes of and 

circumstances behind the generation of 

state prescription monitoring reports 

(PMPs) relative to the Respondent 

maintained by West Virginia, Kentucky, 

and Ohio. Govt. Exs. 98–100. Review of 

the PMP report data reflects that during 

the time period of February 1, 2006 

through February 11, 2010, pharmacies 

filled 167 controlled substance 

prescriptions issued over the 

Respondent’s signature to fifty-four 

patients located in West Virginia, 110 

similar prescriptions provided to fiftyseven Kentucky-based patients were 

filled between January 1, 2009 and April 

4, 2010, and sixty-six such prescriptions 

pertaining to twenty-eight patients 

located in Ohio were filled between 

April 1, 2008 and April 19, 2010. Id. 

No evidence was introduced at the 

hearing that would provide any reliable 

level of context regarding the raw data 

set forth in the databases received into 

evidence at the Government’s request. 

Other than the observations noted 

above, no witness who testified at the 

hearing ever explained the significance 

of the data set forth in any of these 

databases to any issue that must or 

should be considered in deciding the 

present case. As discussed above, the 

fact that the Boca Drugs Prescription 

Log prepared by the agents does not 

distinguish between prescriptions 

authorized by the Respondent and 

another registrant of the same name 

deprives the document of virtually any 

relevance regarding the enforcement 

action against this Respondent.18

GS Langston provided evidence that 

was sufficiently detailed, consistent and 

plausible to be deemed credible in this 

recommended decision. 

SA Michael Burt testified that he has 

been employed by DEA since March 

2004 and has been stationed with the 

Miami Field Division (MFD) since 

September 2004. Tr. at 813–14. Burt 

testified that he is the lead case agent for 

DEA in the investigation of American 

Pain Clinic and has participated in the 

investigation since the latter part of 

2008. According to Burt, American Pain, 

which was previously known by the 

name South Florida Pain, has conducted 

business at four different locations, and 

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19SA Burt described the pole cameras as ‘‘covert 

cameras that are installed to observe the activity in 

the clinic.’’ Tr. at 816. Burt testified that he was able 

to use a laptop to access the live video feed from 

the cameras after inputting a username and 

password. The camera video was also recorded to 

DVR. Id. at 821. 

20Tr. at 910. 

21SA Burt conceded that although he is the 

designated lead case agent for DEA, he did not 

review all the audio and video tapes made in the 

case or even review the transcripts. Tr. at 1002–05. 

22Later on cross-examination, SA Burt admitted 

that the clinic also accepted payment via credit 

card. Tr. at 916. 23 Inasmuch as the Government provided no 

information from which any specific number of 

patients seen by any given clinic doctor on any day 

could be derived, or any expert testimony regarding 

a reasonable number of pain patients that could or 

should be seen per day, the value of providing the 

raw number of patients walking through the door 

at the clinic is negligible. 

24Burt further testified that the doctors were paid 

$75.00 per patient visit, id. at 884, but because he 

indicated that he could not disclose his basis of 

knowledge for this information, this portion of his 

testimony can be afforded no weight. See 

Richardson v. Perales, 402 U.S. 389, 402 (1971); 

J.A.M. Builders v. Herman, 233 F.3d 1350, 1354 

(11th Cir. 2000); Keller v. Sullivan, 928 F.2d 227, 

230 (7th Cir. 1991); Calhoun v. Bailar, 626 F.2d 145, 

149 (9th Cir. 1980). 

25Tr. at 1002–05. 

26The fact that these recordings were made 

during the course of seven different office visits by 

an undercover agent to both the Boca Raton and 

Lake Worth locations was established on crossexamination. Tr. at 900, 985. 

he surveilled the Boca Raton and Lake 

Worth locations both in person and by 

periodic live review of video captured 

via pole cameras 19 set up outside the 

clinic. Id. at 815–17. These pole 

cameras, which were in operation 

during a three week period from January 

to February 2010, were initially in 

operation on a 24-hour basis, but Burt 

testified that they were later activated 

only between the hours of 7 a.m. 

through 6 p.m. due to an observed lack 

of activity at the clinic outside of that 

time period. Id. at 820–21. The pole 

camera recordings were not offered into 

evidence at the hearing or made 

available to opposing counsel. 

Based on these surveillance efforts, 

SA Burt testified concerning various 

activities he observed occurring outside 

the Boca and Lake Worth clinic 

locations, which were open to the 

public from 8 a.m. to 5 p.m. At the Boca 

location, Burt stated that on any given 

day, beginning at 7 a.m. in the morning, 

automobiles could be seen pulling into 

the parking lot and approximately 

twenty to thirty people were routinely 

lined up outside of the clinic waiting to 

gain admittance. Additionally, there 

was a steady stream of automobile and 

foot traffic in and out of the clinic 

throughout the day. Id. at 817, 821. Burt 

testified that in his estimation, 

approximately 80–90 percent of the 

automobiles had out-of-state tags, 

predominantly from Kentucky, Ohio, 

West Virginia and Tennessee. Id. at 

817–18. Burt also observed security 

personnel with ‘‘staff’’ written on their 

shirts 20 riding around the exterior of the 

building in golf carts and who, in Burt’s 

assessment, appeared to be directing 

patients into the American Pain facility. 

Burt indicated his surveillance of the 

Lake Worth location yielded similar 

observations. Id. at 818. 

Based on his review of some (but not 

all) 21 of the audio and video tapes made 

by agents and informers sent into the 

clinic by the Government at various 

times, SA Burt also testified about his 

understanding of the process by which 

patients obtained controlled substance 

prescriptions at American Pain. 

According to Burt, after entering the 

clinic, a patient would meet with the 

receptionist, who would determine if 

the patient had an MRI. If not, the 

receptionist would issue that individual 

an MRI prescription in exchange for a 

$50 cash payment, and the patient 

‘‘would be directed to a place to obtain 

an MRI.’’ Id. at 822. Burt testified that 

one such MRI location was Faye 

Imaging, which was a mobile MRI trailer 

located behind a gentlemen’s club 

several miles away from American Pain. 

Id. at 822–23. The cost for the MRI was 

$250, and the patient could pay an 

additional fee ‘‘to have the MRI 

expedited and faxed over to American 

Pain.’’ Id. at 823–24. Once the MRI was 

procured and faxed to American Pain, 

the patient would return to the clinic 

and be seen by a doctor. According to 

Burt, the clinic accepted what he 

referred to as ‘‘predominantly cash 

only’’ 22 for these office visits, and the 

six doctors at the clinic saw ‘‘anywhere 

from 200 upward to 375 patients a 

day’’ 23 in this manner.24 Id. at 882–83 

(emphasis supplied). 

SA Burt also testified regarding his 

review of some 25 of the video and audio 

recordings made by an undercover agent 

(UC) named Luis Lopez capturing 

activity inside of American Pain.26 In 

those recordings, Burt observed who he 

believed to be an American Pain 

employee inside the facility standing up 

in a waiting room full of patients and 

directing them ‘‘not to have their 

prescriptions filled out of state, not to go 

out into the parking lot and snort their 

pills,’’ and directing the patients to have 

their prescriptions filled ‘‘in house’’ 

(meaning at American Pain), at ‘‘a 

pharmacy they have in Orlando, 

Florida,’’ or at ‘‘a pharmacy they have 

down the street,’’ which, in Burt’s view, 

was a reference to Boca Drugs. Id. at 

825–26. Burt further testified that the 

purported employee on the recording 

told the patients to ‘‘obey all the traffic 

laws; do not give the police a reason to 

pull you over.’’ Id. Although Burt 

testified as to the contents of these 

recordings, the physical recordings were 

not offered into evidence by the 

Government or made available to 

opposing counsel. 

SA Burt also testified that he received 

information from Dr. Eddie Sollie, a 

former physician employed during the 

time period American Pain was doing 

business as South Florida Pain, who 

terminated his employment at the 

Oakland Park clinic location in 

November or December 2008 after 

working there for approximately two 

and a half to three months. Id. at 827, 

898. During the course of an interview 

where Burt was present, Dr. Sollie 

related various ‘‘concerns about how the 

practice was being handled or 

managed.’’ Id. at 827–28. These concerns 

included medical records being, in his 

opinion, annotated inadequately by the 

doctors, and what he perceived as a lack 

of supervision during patient urinalysis 

testing, where patients would ‘‘go[] to 

the bathrooms together, bringing items 

with them to the bathrooms that could 

possibly disguise the urinalysis.’’ 

According to Burt, Sollie explained that 

he perceived that patients were 

substituting urine produced by other 

persons that contained the metabolites 

for controlled substances that the 

patients claimed to be legitimately 

taking, with a view towards falsely 

providing evidence to the American 

Pain doctors showing that they were 

actually taking prescribed medications 

and not diverting them. Id. at 828–29. 

During cross-examination, Burt 

explained that Dr. Sollie told him he 

had raised these concerns with 

Christopher George, the owner of 

American Pain, and that Burt had no 

evidence that the deficient practices that 

Sollie had objected to continued 

through 2010. Id. at 900, 906. Burt also 

acknowledged that he was aware Dr. 

Sollie had been involved in litigation 

with Mr. George and that their 

relationship was strained. Id. at 1009. 

Dr. Sollie was not called as a witness by 

either party. 

SA Burt also provided testimony 

concerning three confidential sources 

(only one of whom was seen by the 

Respondent) and their contacts with 

doctors at American Pain. Relative to 

the Respondent, based on the 

investigative assistance he provided to 

the Palm Beach County, FL, Sheriff’s 

Office (PBSO), Burt testified regarding 

the circumstances surrounding a 

confidential source’s (CS3) visit to 

obtain controlled substances from 

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27Tr. at 1046. 

28Astonishingly, although SA Burt was offered by 

the Government as the proponent of all of the 

information relative to CS3, he conceded that he 

never listened to the audio tape created as a result 

of the wire worn by the informant. Tr. at 1051. 

According to Burt, the sum total of his awareness 

about the details regarding CS3 was gleaned from 

his presence at the post-encounter debriefing. Id. 

29 5 U.S.C. 556(d). 

30Although similar testimony concerning the 

overdose death of a third individual, OB, was 

noticed in the Government’s prehearing statement, 

it was not offered by the Government at the hearing. 

ALJ Ex. 6 at 8. 

31According to SA Burt, a ‘‘task force officer’’ is 

a local police officer or sheriff’s deputy that is 

assigned to work on a DEA task force, rather than 

a sworn DEA criminal investigator. Tr. at 1031. 

32See Tr. at 836–53 (addressing exclusion of 

Govt. Ex. 27 and associated testimony). 

33ALJ Ex. 6. 

34 Dr. Kennedy’s CV was admitted into evidence. 

Govt. Ex. 117. 

35Tr. at 17. 

American Pain in October 2009.27 Burt 

stated that he was approached by an 

unnamed PBSO officer who advised that 

he had a confidential source ‘‘that could 

go into American Pain and purchase 

oxycodone from one of the doctors.’’ Id. 

at 870. Burt met CS3 at a predesignated 

location, at which time the source was 

searched for contraband and provided 

with a recording device prior to entering 

American Pain to visit the Respondent, 

whom he had a scheduled appointment 

with and had previously been seen by 

at the clinic. Id. at 871, 877, 1050. At a 

subsequent debriefing, Burt testified 

that ‘‘the source told [him] that he went 

into the office with [the Respondent], 

put on the blood pressure cuff himself, 

took his own blood pressure, was given 

no physical exam by the doctor, and left 

with a prescription of oxycodone.’’ Id. at 

878. Burt testified that he was not able 

to simultaneously listen to the audio 

capturing the details of this office visit, 

and further admitted that has not 

reviewed the associated audio 

recording; instead, Burt’s testimony was 

based on his review of a PBSO 

detective’s written report and Burt’s 

participation in the debriefing of CS3. 

Burt’s testimony revealed that the 

investigative assistance of CS3 was 

secured as part of his cooperation with 

PBSO in relation to a pending criminal 

charge. Id. at 1047. Burt declined to 

disclose the name of CS3 when queried 

on cross-examination. Id. at 1045. The 

audio recording made by CS3 was not 

introduced by the Government into 

evidence or provided to opposing 

counsel.28 SA Burt was extremely vague 

and sketchy regarding the details of his 

encounter with CS3 relative to the 

Respondent. Id. at 870–82. In fact, 

without a refreshment of his 

recollection, Burt was not even sure that 

CS3 met with the Respondent, and not 

another American Pain physician with 

the same last name. Id. at 871–77. This 

portion of his testimony was received 

over the vociferous objections of 

Respondent, based on lack of relevance, 

unfair prejudice, and the inability for 

meaningful cross-examination based on 

a lack of access to either the recorded 

audio or even a witness who has heard 

the audio (or even knew the details of 

the visit), in conjunction with the 

absence of evidence of the name that 

would be on the patient chart reflecting 

the office visit. Tr. at 877–82. Under the 

circumstances present here, including 

the tentative nature of his testimony as 

well as the manner in which it was 

produced, which, categorically denied 

the Respondent of any meaningful 

opportunity for the cross-examination 

required by the A.P.A.,29 this aspect of 

Burt’s testimony may be accorded no 

weight. To proceed otherwise would 

deny the Respondent the ability 

guaranteed by the APA ‘‘to conduct such 

cross-examination as may be required 

for a full and true disclosure of the 

facts.’’ 5 U.S.C. 556(d); see Richardson v. 

Perales, 402 U.S. 389, 402 (1971); J.A.M. 

Builders v. Herman, 233 F.3d 1350, 

1354 (11th Cir. 2000); Keller v. Sullivan, 

928 F.2d 227, 230 (7th Cir. 1991); 

Calhoun v. Bailar, 626 F.2d 145, 149 

(9th Cir. 1980); see Tr. at 882. 

SA Burt also testified regarding the 

drug overdose deaths of TY and SM 

after obtaining controlled substances 

from American Pain.30 Burt’s record 

testimony indicates that DEA Task 

Force Officer 31 (TFO) Barry Adams 

informed him that a Kentucky resident 

named TY overdosed in Kentucky from 

oxycodone intoxication induced by 

medication procured at American Pain. 

Burt testified that this information was 

furnished pursuant to a working law 

enforcement relationship between the 

Kentucky State Police, Kentucky FBI, 

Kentucky DEA and Miami DEA aimed at 

addressing ‘‘the brunt of the pill 

problem’’ centered within the state of 

Kentucky relative to illegal use and 

resale of prescription pain medications. 

Id. at 833–35. However, in his 

testimony, Burt was unable to recall the 

name of the doctor from whom TY 

obtained his pills, and, thus, no 

admissible evidence was presented by 

the Government with respect to TY’s 

death.32 Likewise, the record evidence 

concerning SM did not implicate 

prescribing activity by the Respondent. 

Perhaps among the more striking 

aspects of SA Burt’s performance on the 

witness stand is the anticipated 

testimony which he did not provide. 

When viewed in its entirety, SA Burt’s 

record testimony was stunningly sparse 

when compared with his proposed 

testimony as noticed in the 

Government’s prehearing statement.33

That certain information may be 

unavailable for reasons related to other 

litigation forums or other equally valid 

reasons are of no moment with respect 

to the evaluation that must be made at 

this administrative forum. Equally 

important, such considerations do not 

alter the burdens imposed upon the 

respective parties. Simply put, the 

admitted evidence must succeed or fail 

on its own merits, irrespective of 

extraneous considerations. 

Even apart from the marked contrast 

between the Burt testimony as proffered 

and as realized, his testimony was 

marred by periodic memory failures on 

significant issues and an inability to 

supply details to an extent that it could 

arguably have diminished the weight 

that could be fairly attached to those 

aspects of his own investigation that he 

did manage to recollect. During his 

testimony, SA Burt acknowledged his 

own marked lack of preparation and 

unfamiliarity with the investigation and 

confessed simply that ‘‘[t]here’s no 

excuse . * * *’’ Id. at 1003–05. 

Even acknowledging its obvious 

suboptimal aspects, SA Burt’s testimony 

had no apparent nefarious motivation or 

indicia of intentional deceit. Burt came 

across as an earnest and believable 

witness, who, regarding the aspects of 

the case that he did recall, was able to 

impart substantial information about the 

investigation and activities involving 

American Pain and its doctors. While 

frequently lacking in detail, his 

testimony was not internally 

inconsistent or facially implausible, and 

although the legal weight I have 

assigned to certain portions of Burt’s 

testimony varies given the issues 

described, I find his testimony to be 

credible overall. 

The Government presented the bulk 

of its case through the report and 

testimony of its expert, L. Douglas 

Kennedy, M.D., D.A.B.P.M., Affiliate 

Clinical Assistant Professor at the 

University of Miami, Miller School of 

Medicine.34 Dr. Kennedy, who testified 

that he is board certified by the 

American Board of Pain Medicine and 

the American Board of 

Anesthesiology,35 was offered and 

accepted as an expert in the field of pain 

medicine. Id. at 39. 

Dr. Kennedy testified that after a 

review of a group of selected patient 

files from those seized at the 

Respondent’s practice that were to him 

provided by the Government, he 

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36At the request of the Government, a protective 

order was issued that is designed to minimize the 

risk of the dissemination of identifying information 

related to patients and their relatives associated 

with this case. Accordingly, initials have been 

substituted for the names of individuals within the 

protection of the protective order throughout the 

body of this decision. ALJ Ex. 15. 

37The Government’s tactical decision to 

essentially unload a pile of charts that are explained 

only by the representations and generalizations in 

a report, with no attempt whatsoever to have its 

expert witness explain the applicable aspects of 

most charts to this tribunal or any future reviewing 

body is clearly at odds with the directive provided 

by the Deputy Administrator in Gregg & Son 

Distributors that ‘‘it is the Government’s obligation 

as part of its burden of proof and not the ALJ’s 

responsibility to sift through the records and 

highlight that information which is probative of the 

issues in the proceeding.’’ 74 FR 17517 n.1. 

38 Govt. Ex. 101 at 5. 

39 Govt. Ex. 101 at 5. In Dr. Kennedy’s opinion, 

the Respondent ‘‘prescribed, at the first visit, very 

high initial doses of controlled substance 

combinations despite not being within standard of 

care for histories, physical examinations and/or 

absent past medical records.’’ Id. at 8. 

40 Govt. Ex. 101 at 5. 

41 Govt. Ex. 101 at 4. As an example of the failure 

to adhere to the terms of the medication contract, 

Dr. Kennedy cites a contract term that provides 

notice that the physician may stop prescribing 

opioids or change treatment if pain or activity 

improvement is not demonstrated, and points out 

that pain and activity levels are routinely not 

documented in treatment notes. Id. at 4. Similarly, 

Dr. Kennedy references a medication contract 

warning that termination of services may result 

from failure to make regular follow-up 

appointments with primary care physicians, and 

notes that the American Pain charts contain no 

notes from primary care physicians or medical 

records generated by them. Id. at 4–5. 

42 Govt. Ex. 101 at 8. In Dr. Kennedy’s opinion, 

Respondent ‘‘in effect, acted as a ‘barrier’ for [JS] to 

receive appropriate medical evaluation and 

treatment. In other words, the very potent, high 

doses of opioids (oxycodone) and benzodiazepine 

(Xanax) may have masked [JS’s] underlying disease 

process(s), making them more difficult to diagnose, 

and allowing the disease(s) to unnecessarily 

worsen. Without an accurate diagnosis, all [the 

Respondent] was doing was, again, masking or 

covering up the symptoms. Id. at 13. 

43 Govt. Ex. 101 at 8. 

44 Govt. Ex. 101 at 8. 

45 Govt. Ex. 101 at 8. 

46 Govt. Ex. 101 at 17. JS’s chart did not contain 

any past medical records, save for a Lumbar report 

from an MRI performed the day before JS’s first 

clinic visit to see the Respondent. Id. at 11. 

47 Govt. Ex. 101 at 15. 

concluded that the Respondent’s 

physical examinations, treatment plans, 

and patient histories were below the 

standard fixed by the Florida Medical 

Board and that that controlled 

substances was not for a legitimate 

medical purpose. Id. at 585–88. 

Dr. Kennedy took professional issue 

with several aspects of the Respondent’s 

patient care as reflected in the charts 

regarding the prescribing of controlled 

substances. It is apparent from his 

testimony that Dr. Kennedy’s analysis is 

restricted to those matters which can be 

gleaned from an examination of the 

written word in that subset of the 

Respondent’s patient charts provided by 

the Government for his review, and that 

limitation perforce circumscribes the 

breadth of his input. That being said, Dr. 

Kennedy highlighted numerous features 

in the Respondent’s chart 

documentation that he found wanting, 

or at least remarkable. 

Dr. Kennedy explained that there are 

basic elements to practicing pain 

medicine. The acquisition of a thorough 

history and physical examination is 

important. Id. at 41–42. He also stressed 

the vital importance of obtaining past 

medical records to evaluate what 

treatments, therapies, medications, and 

dosages have been utilized in the past 

so that correct current treatment 

decisions can be made. Id. at 45–46. 

Reliance upon the patient’s memory of 

these elements without the prior 

medical records, in Dr. Kennedy’s view 

is not reliable or acceptable. Id. at 46– 

47. Dr. Kennedy acknowledged that 

physicians customarily accept patients 

at their word, but on the subject of 

verifying a patient’s subjective 

complaint and medication history, Dr. 

Kennedy explained that 

[s]ometimes you have to help people 

understand why they’re suffering or what 

their problems are. A person with an 

addiction or drug abuse problem is no worse 

a human being than me. I’m not any better 

than them. But it’s your job as a doctor to sit 

down and find out what the truth is as well 

as you reasonably can under the 

circumstances. 

Id. at 357. 

Dr. Kennedy prepared a report in 

connection with the Government’s case 

against the Respondent, which is dated 

April 30, 2010, and was admitted into 

evidence. Govt. Ex. 101; Tr. at 585. The 

report describes a general analysis of 

sixteen charts that the Respondent 

maintained on as many patients, that 

were (selected by and) provided to Dr. 

Kennedy by the Government from 

among patient files seized pursuant to a 

criminal search warrant executed at the 

Respondent’s practice on March 3, 2010 

(Patient Charts Analysis). Although this 

report purports to describe practices 

common to all sixteen files reviewed by 

Dr. Kennedy, much of the analysis is 

directed toward a chart prepared in 

connection with JS,36 one of the 

Respondent’s patients. 

Dr. Kennedy’s report makes it 

unambiguously clear that, in his 

opinion, all sixteen of the Respondent’s 

charts that he reviewed suffered from 

the same shortcomings.37 The Patient 

Charts Analysis states that the 

Respondent’s patient charts that Dr. 

Kennedy reviewed ‘‘are essentially the 

same with regard to review issues; as 

stated in the report of [JS] referenced 

and discussed in this report in detail, 

[and that] there were no significant 

differences that affected [his] 

conclusions and summary.’’ Govt. Ex. 

101 at 2. 

In Dr. Kennedy’s opinion, the patient 

charts he reviewed that were prepared 

by the Respondent reflected care that 

fell below the applicable standard on 

multiple levels. In his report, Dr. 

Kennedy noted that the treatment notes 

in the charts: (1) Contained no 

typewritten clinical notes and were 

‘‘very brief, difficult to read (often 

impossible) and not within the standard 

of care due to their brevity and 

quality’’; 38 (2) reflected prescriptions, 

right from the initial patient visit, that 

‘‘were almost entirely for controlled 

substances, most often one or two 

immediate release oxycodone pills 

* * * with Xanax,’’ and which were, in 

Dr. Kennedy’s view, inappropriate and 

more powerful than justified by the 

objective signs documented in the 

written notes; 39 (3) showed that ‘‘the 

same or very similar ‘drug cocktails’ 

were prescribed [among all patients in 

the reviewed files] in the same or very 

similar doses, [directions] * * * with a 

30-day supply,’’ and were affixed to the 

prescription scripts with a few prepared 

stamps utilized by all American Pain 

physicians that reflected ‘‘drug, dose, sig 

(directions) and quantity dispensed’’; 40

(4) contained medication contracts that 

were ‘‘not always signed’’ and ‘‘listed 

criteria that was not followed by the 

doctors at American Pain;’’ 41 (5) failed 

to document the efficacy of the 

prescribed medication; (6) did not set 

forth a ‘‘diagnostic plan except to obtain 

an occasional MRI, the results of which 

made no difference in the 

‘treatment’ ’’; 42 (7) reflected ‘‘no 

therapeutic plan, except to use 

controlled substances to ‘treat’ the 

subjective complaint of ‘pain’ which 

was inadequately described’’; 43 (8) 

reflected ‘‘no real therapeutic goals 

* * * for improvement of quality of life 

(activities of daily living, work, sleep, 

mood)’’; 44 (9) did not reflect 

‘‘consultations with other physicians or 

specialists outside the American Pain 

group [which] could have and in some 

cases should have included orthopedics, 

neurology, neurosurgery, psychiatry, 

addiction medicine and psychology’’; 45

(10) reflected ‘‘a gross lack of past 

medical records in all charts reviewed 

and in some cases none at all’’; 46 and, 

(11) demonstrated controlled substance 

patient monitoring practices that were 

‘‘not within the standard of care and was 

outside the boundaries of professional 

practice.’’ 47

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48 Govt. Ex. 101 at 17. 

49 Govt. Ex. 101 at 15. 

50 Govt. Ex. 101 at 10, 17. 

51 Govt. Ex. 101 at 17. 

52 Dr. Kennedy did not testify that a referral that 

emanated from a source other than a physician 

could or should be a basis for a diversion red flag 

on a given case. His opinion was limited to culling 

some manner of a trend or pattern. In view of the 

fact that the record contains no development of the 

numbers of files with non-physician referrals versus 

the total number of files, or even an acceptable 

metric upon which the issue could be evaluated, 

there is very little useful analysis that can come 

from Dr. Kennedy’s observation regarding the files 

he reviewed. 

53Although the disclosed date the medications 

were last prescribed could provide a plausible 

explanation for the discrepancy, this misses the 

point. These types of inconsistencies raise potential 

red flags that require a prudent registrant to make 

additional inquiry and document, at a minimum, 

how the issue has been resolved to the satisfaction 

of the registrant before controlled substance 

prescriptions are issued. 

54 It is notable that patient ‘‘CA’’ is referred to 

using three different last names in the patient file 

records covering the period of time from 11/3/09 to 

2/4/10, only one of which is present on her driver’s 

license. See Govt. Ex. 103 at 1–2, 4, 8. This 

discrepancy is not addressed in any manner in the 

documentation. 

Dr. Kennedy found the Respondent’s 

controlled substance patient monitoring 

to be deficient in numerous respects. 

From the reviewed patient charts, Dr. 

Kennedy gleaned that an initial, inoffice urine drug screen was frequently 

executed during the patients’ initial 

visit to the office but repeated only 

occasionally. Govt. Ex. 101 at 15. It was 

Dr. Kennedy’s observation that even a 

drug screen anomaly did not alter the 

seemingly inexorable continuation of 

controlled substance prescribing from 

the Respondent. Id. Dr. Kennedy also 

noted that the Respondent did not 

utilize out-of-office toxicology tests, or 

obtain out-of-state prescription 

monitoring program or outside 

pharmacy drug profiles. Furthermore, 

the charts contained only rare evidence 

of contact with primary care physicians, 

treating physicians, pharmacists, or 

other health care providers. Id. at 15–16. 

The identified shortcomings of 

controlled substance patient monitoring 

systems was of particular significance 

where Dr. Kennedy identified specific 

evidence that he identified as ‘‘red flags’’ 

of possible or likely diversion. Red flags 

noted by Dr. Kennedy in the reviewed 

charts included the relatively young age 

of the Respondent’s chronic pain 

patients,48 incomplete history 

information provided by the patients, 

periodically significant gaps between 

office visits,49 referrals from friends, 

relatives, or advertising, but not other 

physicians,50 and the fact that a 

relatively high number of patients were 

traveling significant distances to 

American Pain for pain treatment, 

although no physician employed at that 

facility had any specialized training in 

pain management.51

Dr. Kennedy also found it remarkable 

that each American Pain patient file 

provided notice to its patients that 

American Pain did not accept any form 

of health care insurance. Govt. Ex. 101 

at 3, 17. Dr. Kennedy’s report set forth 

his opinion that this practice was 

designed to ‘‘effectively keep [the 

physicians at American Pain] ‘off the 

radar’ from monitoring by any private 

health care insurance company as well 

as all state and federal agencies 

(Medicaid and Medicare respectively). 

Id. at 17. Significantly, however, when 

asked, Dr. Kennedy acknowledged that 

he conducts his own current medical 

practice on a cash-only basis. Tr. at 151. 

Regarding the discomfiture that Dr. 

Kennedy expressed regarding nonphysician referrals in his report, during 

his testimony at the hearing, he clarified 

that it was not unusual for a physician 

to treat patients that have been referred 

by relatives and friends. Tr. at 154. 

Further, Kennedy conceded while in the 

course of his own medical practice he 

has treated patients referred by family 

and friends, and that in his report he 

was focusing on what he perceived as a 

lack of any referrals by physicians in the 

files he reviewed, or what he perceived 

as ‘‘trends’’ or ‘‘patterns.’’ Tr. at 154–55. 

Given Dr. Kennedy’s acknowledgement 

that such referrals are not unusual, 

coupled with the absence of any recordevidence way to measure the relative 

percentage of physician referrals in the 

Respondent’s practice, the observations 

regarding referral sources are of limited 

value here.52

A review of the sixteen patient files 

that informed the analysis, findings and 

conclusions offered in Dr. Kennedy’s 

written report and testimony does 

reflect the presence of at least some of 

the red flag issues he identified therein, 

but there was not the unanimity among 

the files that he repeatedly urges. For 

instance, in terms of evidence related to 

therapeutic plans, it is notable that 

Respondent’s patient files contain at 

least some indications of recommended 

treatment modalities in addition to the 

Respondent’s exclusive use of 

controlled substances for pain 

management. There are notations in the 

charts reflecting a patient was to see a 

‘‘PCP,’’ or primary care physician, 

regarding jaundice, Govt. Ex. 108 at 9; 

in another patient file, a note listed 

under referrals reads ‘‘ER for eval of 

Cellulite + Possible IV ATBx.’’ Govt. Ex. 

109 at 1. 

An examination of the reviewed 

patient charts does reveal the presence 

of other red flags that should have 

inspired additional diligence or inquiry 

on the part of the Respondent. RR’s 

patient file, for example, contains a form 

indicating a positive UDS for oxycodone 

and benzodiazepine from 11/20/08, yet 

on the same date, the medication 

contract signed by RR is blank in that 

portion of the form designated for the 

patient to reveal any medications he or 

she is currently taking. Govt. Ex. 105 at 

15, 31; see also Govt. Exs. 107 at 8–9, 

21; 109 at 46, 54–55; 114 at 8–9, 20 

(similar issues). Patient RS’s file 

indicates a positive test for oxycodone 

on 9/10/09, yet on her medication 

contract sharing the same date, she 

crosses out her handwritten listings of 

Percocet and Xanax, and notes ‘‘*Sorry 

am not currently taking*.’’ Govt. Ex. 110 

at 10, 26. DS’s patient file indicates a 

positive UDS for oxycodone and 

benzodiazepine only on January 14, 

2010; however, the patient indicates 

elsewhere on a medical form filled out 

on the same date, in response to a 

question concerning whether she has 

taken any illegal or illicit drugs in the 

last 30 days, that she ‘‘smoked some 

marijuana because of [her] cancer.’’ This 

disclosure notwithstanding, the lack of 

an indication of a positive ‘‘THC’’ result 

on the aforementioned UDS form is not 

addressed by the Respondent anywhere 

in the patient file. Govt. Ex. 112 at 10, 

19. Patient JR’s 7/17/09 UDS indicates a 

negative test for all listed substances, 

yet on two different forms dated 7/13/ 

09 she indicates she is currently taking 

hydrocodone or Lortab, a discrepancy 

which raises questions about the 

validity of the testing procedures and/or 

the patient’s candor. Govt. Exs. 106 at 

12–13, 30; see also Govt. Ex. 113 at 11– 

12, 29 53 (similar issue). Patient CA’s 54

UDS form, on the other hand, lists a 

positive test result for oxycodone only 

on 11/3/09, yet the patient states she is 

also currently taking Xanax elsewhere 

on the medical forms from the same 

date. Govt. Ex. 103 at 10–11, 24; see also 

Govt. Ex. 116 at 17–18, 42 (same issue). 

A prescribed controlled substance that 

is not reflected in a drug screen should 

have raised a sufficient suspicion of 

diversion to merit further inquiry by the 

registrant reflected in the patient file. At 

a minimum, these observations support 

the conclusion there was a general lack 

of vigilance on the part of the 

Respondent regarding his obligations as 

a registrant to minimize the risk of 

controlled substance diversion. 

In addition to the lack of adequately 

completed forms in some patient files 

noted by Dr. Kennedy, other patient 

files appear to be missing key 

documentation altogether. For instance, 

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55Tr. at 628. 

56The Respondent did not testify on her own 

behalf. 

57This authority has been delegated pursuant to 

28 CFR 0.100(b) and 0.104. 

patient RR’s file contains a South 

Florida Pain Management Clinic 

physical examination form that was not 

filled out, and no physical examination 

form is present in the file reflecting such 

an exam was conducted by the 

Respondent. See Govt. Ex. 105 at 9–10. 

Dr. Kennedy concluded his report 

regarding the Respondent’s prescribing 

practices with the following summary: 

[The Respondent] was not engaged in the 

practice of medicine, rather he was engaged 

in an efficient, ‘‘[a]ssembly [l]ine’’ business. 

His ‘‘patients’’ were revenue streams, not true 

patients. This business allowed him to 

collect cas[h] for office visits as well as being 

a ‘‘[d]ispensing [p]hysician’’ for controlled 

substances. He prescribed controlled 

substances so that ‘‘patients’’ would return to 

his office on a regular basis, allowing him to 

generate further revenue. [The Respondent’s] 

routine and excessive prescription of 

multiple controlled substances (oxycodone 

and Xanax) and lack of arriving at a valid 

medical diagnosis and treatment most likely 

caused harm to the ‘‘patients’’ he saw. Drug 

diversion most likely caused a ‘‘mushroom’’ 

effect of increased drug abuse, drug 

addiction, drug overdoses, serious bodily 

injury and death in those communities 

spread over several different states. [The 

Respondent’s] continued ability to prescribe 

controlled substances will only perpetuate 

the suffering and be a threat to the public. 

Govt. Ex. 101 at 18. 

On cross examination, Dr. Kennedy 

agreed that he assumed, for the 

purposes of his analysis, that where the 

Respondent’s charts reflected an entry 

or a procedure, that the event actually 

occurred. Tr. at 654. Kennedy also 

acknowledged that every one of the 

patient files he reviewed contained at 

least a complaint of chronic pain 

symptoms by the patient and MRI 

results that could support such a 

diagnosis. Id. at 655–57. 

The Government’s presentation of Dr. 

Kennedy’s testimony at the hearing was 

substantially consistent with the 

conclusions included in the Patient 

Charts Analysis, but Dr. Kennedy’s 

presentation was clearly not without its 

blemishes. Although he testified that he 

was familiar with prescribing practices 

in Florida, and that he utilized the 

medical standards applicable to Florida 

practice,55 he was unable to identify the 

documentation standard in the Florida 

Administrative code with any degree of 

particularity, and he also acknowledged 

that he was not aware of what the 

standard is in Florida Medical Board 

administrative decisions regarding the 

overprescribing of medication or what 

constitutes an adequate medical history. 

Id. at 149–51, 233, 304. While, overall, 

Kennedy presented testimony that 

appeared candid and knowledgeable, 

there were areas in his written report 

that rang of hyperbole and overembellishment. The reasoning behind 

some of the seemingly critical 

observations in the written report, such 

as the ‘‘cash basis’’ of the Respondent’s 

practice and the absence of doctor 

referrals among the reviewed patient 

files, did not well survive the crucible 

of cross examination at the hearing. 

However, overall, Dr. Kennedy’s 

testimony was sufficiently detailed, 

plausible, and internally consistent to 

be considered credible, and, consistent 

with his qualifications, he spoke 

persuasively and with authority on 

some relevant issues within his 

expertise, and notwithstanding the 

Respondent’s objections relative to his 

Florida-related experience, he is 

currently an assistant professor teaching 

at a Florida Medical School. It may well 

be that the greatest and most significant 

aspect of Dr. Kennedy’s opinion is that 

on the current record, it stands 

unrefuted. Thus, his opinion is the only 

expert opinion available for reliance in 

this action.56 Accordingly, Dr. 

Kennedy’s expert opinion that the 

Respondent’s controlled substance 

prescribing practices, at least as 

evidenced through his examination of 

the patient charts he reviewed, fell 

below the standards applicable in 

Florida, and that the controlled 

substance prescriptions contained in 

those files were not issued for a 

legitimate medical purpose is unrefuted 

on this record and (although by no 

means overwhelming) is sufficiently 

reliable to be accepted and relied upon 

in this recommended decision. 

The Analysis 

Pursuant to 21 U.S.C. 824(a)(4), the 

Deputy Administrator 57 may revoke a 

registrant’s DEA Certificate of 

Registration if persuaded that the 

registrant ‘‘has committed such acts that 

would render * * * registration under 

section 823 * * * inconsistent with the 

public interest * * *.’’ The following 

factors have been provided by Congress 

in determining ‘‘the public interest’’: 

(1) The recommendation of the appropriate 

State licensing board or professional 

disciplinary authority. 

(2) The applicant’s experience in 

dispensing, or conducting research with 

respect to controlled substances. 

(3) The applicant’s conviction record under 

Federal or State laws relating to the 

manufacture, distribution, or dispensing of 

controlled substances. 

(4) Compliance with applicable State, 

Federal or local laws relating to controlled 

substances. 

(5) Such other conduct which may threaten 

the public health and safety. 

21 U.S.C. 823(f). 

‘‘[T]hese factors are considered in the 

disjunctive.’’ Robert A. Leslie, M.D., 68 

FR 15227, 15230 (2003). Any one or a 

combination of factors may be relied 

upon, and when exercising authority as 

an impartial adjudicator, the Deputy 

Administrator may properly give each 

factor whatever weight she deems 

appropriate in determining whether an 

application for a registration should be 

denied. JLB, Inc., d/b/a Boyd Drugs, 53 

FR 43945 (1988); England Pharmacy, 52 

FR 1674 (1987); see also David H. Gillis, 

M.D., 58 FR 37507, 37508 (1993); Joy’s 

Ideas, 70 FR 33195, 33197 (2005); Henry 

J. Schwarz, Jr., M.D., 54 FR 16422 

(1989). Moreover, the Deputy 

Administrator is ‘‘not required to make 

findings as to all of the factors * * *.’’ 

Hoxie v. DEA, 419 F.3d 477, 482 (6th 

Cir. 2005); see also Morall v. DEA, 412 

F.3d 165, 173–74 (D.C. Cir. 2005). The 

Deputy Administrator is not required to 

discuss consideration of each factor in 

equal detail, or even every factor in any 

given level of detail. Trawick v. DEA, 

861 F.2d 72, 76 (4th Cir. 1988) (the 

Administrator’s obligation to explain 

the decision rationale may be satisfied 

even if only minimal consideration is 

given to the relevant factors and remand 

is required only when it is unclear 

whether the relevant factors were 

considered at all). The balancing of the 

public interest factors ‘‘is not a contest 

in which score is kept; the Agency is not 

required to mechanically count up the 

factors and determine how many favor 

the Government and how many favor 

the registrant. Rather, it is an inquiry 

which focuses on protecting the public 

interest * * *.’’ Jayam Krishna-Iyer, 

M.D., 74 FR 459, 462 (2009). 

In an action to revoke a registrant’s 

DEA COR, the DEA has the burden of 

proving that the requirements for 

revocation are satisfied. 21 CFR 

1301.44(e). Once DEA has made its 

prima facie case for revocation of the 

registrant’s DEA Certificate of 

Registration, the burden of production 

then shifts to the Respondent to show 

that, given the totality of the facts and 

circumstances in the record, revoking 

the registrant’s registration would not be 

appropriate. Morall, 412 F.3d at 174; 

Humphreys v. DEA, 96 F.3d 658, 661 

(3d Cir. 1996); Shatz v. U.S. Dept. of 

Justice, 873 F.2d 1089, 1091 (8th Cir. 

1989); Thomas E. Johnston, 45 FR 72, 

311 (1980). Further, ‘‘to rebut the 

Government’s prima facie case, [the 

Respondent] is required not only to 

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accept responsibility for [the 

established] misconduct, but also to 

demonstrate what corrective measures 

[have been] undertaken to prevent the 

reoccurrence of similar acts.’’ Jeri 

Hassman, M.D., 75 FR 8194, 8236 

(2010). 

Where the Government has sustained 

its burden and established that a 

registrant has committed acts 

inconsistent with the public interest, 

that registrant must present sufficient 

mitigating evidence to assure the 

Deputy Administrator that he or she can 

be entrusted with the responsibility 

commensurate with such a registration. 

Steven M. Abbadessa, D.O., 74 FR 10077 

(2009); Medicine Shoppe-Jonesborough, 

73 FR 364, 387 (2008); Samuel S. 

Jackson, D.D.S., 72 FR 23848, 23853 

(2007). Normal hardships to the 

practitioner, and even the surrounding 

community, that are attendant upon the 

lack of registration are not a relevant 

consideration. Abbadessa, 74 FR at 

10078; see also Gregory D. Owens, 

D.D.S., 74 FR 36751, 36757 (2009). 

The Agency’s conclusion that past 

performance is the best predictor of 

future performance has been sustained 

on review in the courts, Alra Labs. v. 

DEA, 54 F.3d 450, 452 (7th Cir. 1995), 

as has the Agency’s consistent policy of 

strongly weighing whether a registrant 

who has committed acts inconsistent 

with the public interest has accepted 

responsibility and demonstrated that he 

or she will not engage in future 

misconduct. Hoxie, 419 F.3d at 483; 

George C. Aycock, M.D., 74 FR 17529, 

17543 (2009); Abbadessa, 74 FR at 

10078; Krishna-Iyer, 74 FR at 463; 

Medicine Shoppe, 73 FR at 387. 

While the burden of proof at this 

administrative hearing is a 

preponderance-of-the-evidence 

standard, see Steadman v. SEC, 450 U.S. 

91, 100–01 (1981), the Deputy 

Administrator’s factual findings will be 

sustained on review to the extent they 

are supported by ‘‘substantial evidence.’’ 

Hoxie, 419 F.3d at 481. While ‘‘the 

possibility of drawing two inconsistent 

conclusions from the evidence’’ does not 

limit the Deputy Administrator’s ability 

to find facts on either side of the 

contested issues in the case, Shatz, 873 

F.2d at 1092; Trawick, 861 F.2d at 77, 

all ‘‘important aspect[s] of the problem,’’ 

such as a respondent’s defense or 

explanation that runs counter to the 

Government’s evidence, must be 

considered. Wedgewood Vill. Pharmacy 

v. DEA, 509 F.3d 541, 549 (D.C. Cir. 

2007); Humphreys, 96 F.3d at 663. The 

ultimate disposition of the case must be 

in accordance with the weight of the 

evidence, not simply supported by 

enough evidence to justify, if the trial 

were to a jury, a refusal to direct a 

verdict when the conclusion sought to 

be drawn from it is one of fact for the 

jury. Steadman, 450 U.S. at 99 (internal 

quotation marks omitted). 

Regarding the exercise of 

discretionary authority, the courts have 

recognized that gross deviations from 

past agency precedent must be 

adequately supported, Morall, 412 F.3d 

at 183, but mere unevenness in 

application does not, standing alone, 

render a particular discretionary action 

unwarranted. Chein v. DEA, 533 F.3d 

828, 835 (D.C. Cir. 2008) (citing Butz v. 

Glover Livestock Comm. Co., Inc., 411 

U.S. 182, 188 (1973)), cert. denied, l 

U.S. l, 129 S.Ct. 1033 (2009). It is wellsettled that since the Administrative 

Law Judge has had the opportunity to 

observe the demeanor and conduct of 

hearing witnesses, the factual findings 

set forth in this recommended decision 

are entitled to significant deference, 

Universal Camera Corp. v. NLRB, 340 

U.S. 474, 496 (1951), and that this 

recommended decision constitutes an 

important part of the record that must 

be considered in the Deputy 

Administrator’s decision, Morall, 412 

F.3d at 179. However, any 

recommendations set forth herein 

regarding the exercise of discretion are 

by no means binding on the Deputy 

Administrator and do not limit the 

exercise of that discretion. 5 U.S.C. 

557(b); River Forest Pharmacy, Inc. v. 

DEA, 501 F.2d 1202, 1206 (7th Cir. 

1974); Attorney General’s Manual on the 

Administrative Procedure Act 8 (1947). 

Factors 1 and 3: The Recommendation 

of the Appropriate State Licensing 

Board or Professional Disciplinary 

Authority and Conviction Record 

Under Federal or State Laws Relating 

to the Manufacture, Distribution, or 

Dispensing of Controlled Substances 

In this case, it is undisputed that the 

Respondent holds a valid and current 

state license to practice medicine. The 

record contains no evidence of a 

recommendation regarding the 

Respondent’s medical privileges by any 

cognizant state licensing board or 

professional disciplinary authority. 

However, that a state has not acted 

against a registrant’s medical license is 

not dispositive in this administrative 

determination as to whether 

continuation of a registration is 

consistent with the public interest. 

Patrick W. Stodola, M.D., 74 FR 20727, 

20730 (2009); Jayam Krishna-Iyer, 74 FR 

at 461. It is well-established Agency 

precedent that a ‘‘state license is a 

necessary, but not a sufficient condition 

for registration.’’ Leslie, 68 FR at 15230; 

John H. Kennedy, M.D., 71 FR 35705, 

35708 (2006). Even the reinstatement of 

a state medical license does not affect 

the DEA’s independent responsibility to 

determine whether a registration is in 

the public interest. Mortimer B. Levin, 

D.O., 55 FR 9209, 8210 (1990). The 

ultimate responsibility to determine 

whether a registration is consistent with 

the public interest has been delegated 

exclusively to the DEA, not to entities 

within state government. Edmund 

Chein, M.D., 72 FR 6580, 6590 (2007), 

aff’d, Chein v. DEA, 533 F.3d 828 (D.C. 

Cir. 2008), cert. denied, l U.S. l, 129 

S.Ct. 1033 (2009). Congress vested 

authority to enforce the CSA in the 

Attorney General and not state officials. 

Stodola, 74 FR at 20375. Thus, on these 

facts, the fact that the record contains no 

evidence of a recommendation by a state 

licensing board does not weigh for or 

against a determination as to whether 

continuation of the Respondent’s DEA 

certification is consistent with the 

public interest. 

Similarly, regarding Factor 3, while 

testimony was received at the hearing 

that indicated that a criminal search 

warrant was executed regarding the 

Respondent and American Pain, the 

record contains no evidence that the 

Respondent has ever been convicted of 

any crime or even arrested in 

connection with any open criminal 

investigation. Thus, consideration of the 

record evidence under the first and 

third factors does not militate in favor 

of revocation. 

Factors 2, 4 and 5: The Respondent’s 

Experience in Dispensing Controlled 

Substances, Compliance With 

Applicable State, Federal or Local Laws 

Relating to Controlled Substances, and 

Such Other Conduct Which May 

Threaten the Public Health and Safety 

In this case, the gravamen of the 

allegations in the OSC/ISO, as well as 

the factual concentration of much of the 

evidence presented, share as a principal 

focus the manner in which the 

Respondent has managed that part of his 

practice relative to prescribing and 

dispensing controlled substances and 

acts allegedly committed in connection 

with his practice at American Pain. 

Thus, it is analytically logical to 

consider public interest factors two, four 

and five together. That being said, 

factors two, four and five involve 

analysis of common and distinct 

considerations. 

Regarding Factor 2, the qualitative 

manner and the quantitative volume in 

which a registrant has engaged in the 

dispensing of controlled substances, and 

how long he has been in the business of 

doing so are factors to be evaluated in 

reaching a determination as to whether 

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58The statutory definition of the term ‘‘dispense’’ 

includes the prescribing and administering of 

controlled substances. 21 U.S.C. 802(10). 

he should be entrusted with a DEA 

certificate. In some cases, viewing a 

registrant’s actions against a backdrop of 

how he has performed activity within 

the scope of the certificate can provide 

a contextual lens to assist in a fair 

adjudication of whether continued 

registration is in the public interest. 

There are two principal 

considerations embedded within a 

consideration of this public interest 

factor. In considering a similar factor 

under the List I chemical context, the 

Agency has recognized that the level of 

experience held by those who will be 

charged with recognizing and taking 

steps to minimize diversion factors 

greatly in determining whether 

entrusting a COR will be in the public 

interest. See Volusia Wholesale, 69 FR 

69409, 69410 (2004); Xtreme Enters., 

Inc., 67 FR 76195, 76197–98 (2004); 

Prachi Enters., 69 FR 69407, 69409 

(2004); J&S Distribs., 69 FR 62089, 

62090 (2004); K.V.M. Enters., 67 FR 

70968, 70969 (2002). The Agency has 

also recognized that evidence that a 

registrant may have conducted a 

significant level of sustained activity 

within the scope of the registration for 

a sustained period is a relevant and 

correct consideration, which must be 

accorded due weight. However, this 

factor can be outweighed by acts held to 

be inconsistent with the public interest. 

Experience which occurred prior and 

subsequent to proven allegations of 

malfeasance may be relevant. Evidence 

that precedes proven misconduct may 

add support to the contention that, even 

acknowledging the gravity of a 

particular registrant’s transgressions, 

they are sufficiently isolated and/or 

attenuated that adverse action against its 

registration is not compelled by public 

interest concerns. Likewise, evidence 

presented by the Government that the 

proven allegations are consistent with a 

consistent past pattern of poor behavior 

can enhance the Government’s case. 

In this case, the Respondent 

introduced no evidence regarding his 

level of knowledge and experience, or 

even the quality or length of his 

experience as a physician-registrant, but 

the Government has elected to do so. 

Regarding the Government’s 

presentation, Agency precedent has long 

held that in DEA administrative 

proceedings that ‘‘the parameters of the 

hearing are determined by the 

prehearing statements.’’ CBS Wholesale 

Distribs., 74 FR 36746, 36750 (2009) 

(citing Darrel Risner, D.M.D., 61 FR 728, 

730 (1996); see also Roy E. Berkowitz, 

M.D., 74 FR 36758, 36759–60 (2009) 

(‘‘pleadings in administrative 

proceedings are not judged by the 

standards applied to an indictment at 

common law’’ and ‘‘the rules governing 

DEA hearings do not require the 

formality of amending a show cause 

order to comply with the evidence’’). 

That being said, however, the marked 

difference between the amount of 

evidence that the Government noticed 

in its OSC/ISO and the amount that it 

introduced at the hearing is striking. For 

example, contrary to its allegations, 

there was no evidence that the 

Respondent ‘‘prescribe[d] and 

dispense[d] inordinate amounts of 

controlled substances,’’ that the 

‘‘majority’’ of the Respondent’s patients 

were ‘‘from states other than Florida,’’ 

and there was no evidence that 

American Pain patients were issued 

‘‘pre-signed prescriptions to obtain 

MRI[s],’’ nor was there evidence that 

individuals positioned outside the 

American Pain building were there to 

‘‘monitor the activity of patients in the 

parking lot to prevent patients from 

selling their recently obtained controlled 

substances.’’ Likewise, no evidence was 

introduced at the hearing that could 

support the allegations that ‘‘employees 

of American Pain [] frequently ma[d]e 

announcements to patients in the clinic 

advising them on how to avoid being 

stopped by law enforcement upon 

departing the pain clinic’’ and 

‘‘frequently ma[d]e announcements [] 

advising [patients], among other things, 

not to attempt to fill their prescriptions 

at out-of state pharmacies and warning 

them against trying to fill their 

prescriptions at particular local retail 

pharmacies.’’ ALJ Ex. 1 (emphasis 

supplied). 

In like fashion, the Government’s 

prehearing statement proffered that SA 

Burt would testify to several of the items 

described but not established in the 

OSC/ISO. Among the list of allegations 

that were not supported by any 

evidence introduced at the hearing, 

were representations that SA Burt 

would testify concerning the following: 

Law enforcement in Florida and [other 

states that correspond to license plates seen 

in the American Pain parking lot] frequently 

arrest people for illegal possession and/or 

illegal distribution of controlled substances 

who have obtained the controlled substances 

from American Pain; 

American Pain hired individuals to ‘‘roam’’ 

the parking lot of the clinic to dissuade 

people from selling their recently obtained 

controlled substances on the property; 

[The reason American Pain placed] signs 

within American Pain warning individuals 

not to have their prescriptions filled at 

Walgreens pharmacies [is] because Walgreens 

refuses to dispense the prescriptions; 

Walgreens has flagged all American Pain 

doctors and will not fill any of their 

prescriptions; 

[Physical exams at American Pain are] 

usually no more than a blood pressure check 

and some bending and stretching; 

Dismissed patients would be routed to 

other doctors within the clinic; 

[There was] co-mingling of [American 

Pain] physician’s drugs; 

[American Pain maintained] no inventories 

of drugs dispensed; 

[Details surrounding] the death of 

[American Pain] patient OB [where] [t]he 

cause of death was determined to be drug 

intoxication—opiate and benzodiazepine; 

[Information] from a confidential source 

[who indicated] that she traveled to 

American Pain in order to obtain controlled 

substances that were later sold in Kentucky 

for $25 per pill[,] [that] [the American Pain 

physician she encountered] did not spend 

any significant time conducting a physical 

examination of [her] [,] [that she would 

simply ask questions regarding [her] well 

being and would then ‘‘stamp’’ a prescription 

for [controlled substances][,] * * * that on 

one visit [during a power failure a] security 

guard working for the clinic instructed 

everyone to be patient and that the doctors 

would be with them shortly to ‘‘get your fix.’’ 

ALJ Ex. 6 at 3–9. 

To be clear, it is not that the evidence 

was introduced and discredited; no 

evidence to support these (and other) 

allegations was introduced at all. To the 

extent the Government had this 

evidence, it left it home. While the 

stunning disparity between the 

allegations proffered and those that 

were supported with any evidence does 

not raise due process concerns, it is 

worthy of noting, without deciding the 

issue, that Agency precedent has 

acknowledged the Supreme Court’s 

recognition of the applicability of the 

res judicata doctrine in DEA 

administrative proceedings. Christopher 

Henry Lister, P.A., 75 FR 28068, 28069 

(2010) (citing Univ. of Tenn. v. Elliot, 

478 U.S. 788, 797–98 (1986) (‘‘When an 

administrative agency is acting in a 

judicial capacity and resolves disputed 

issues of fact properly before it which 

the parties have had an adequate 

opportunity to litigate, the courts have 

not hesitated to apply res judicata[.]’’) 

The evidence the Government did 

present raises issues regarding not only 

Factor 2 (experience dispensing 58

controlled substances), but also Factors 

4 (compliance with federal and state law 

relating to controlled substances) and 5 

(other conduct which may threaten 

public health and safety). Succinctly 

put, the Government’s evidence related 

to the manner in which the Respondent 

practiced, and whether his practice 

complied with the law and/or was a 

threat to the public. 

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59ALJ Ex. 6 at 11–12. 

60Tr. at 825. 

61Tr. at 826. 

62Tr. at 898. 

63 21 U.S.C. 823(f). 

64 ‘‘Ultimate user’’ is defined as ‘‘a person who has 

lawfully obtained, and who possesses, a controlled 

substance for his own use or for the use of a 

member of his household or for an animal owned 

by him or by a member of his household.’’ 21 U.S.C. 

802(27). 

While true that GS Langston 

convincingly testified about the course 

of her investigation and laid an 

adequate foundation for numerous 

database results, the Government 

provided no foundational context for 

any relevant uses for those database 

results. Even apart from the unfortunate 

reality that one of the databases 

contained data that could not be directly 

tied to this Respondent as opposed to 

another with the same last name, 

without some insight into what types of 

results from these databases should be 

expected when compared to similarlysituated registrants engaged in 

acceptable prescribing practices, the raw 

data is without use. In short, there was 

no evidence elicited wherein the 

percentage of the Respondent’s in-state 

to out-of state patients could be 

assessed, and no reasonable measuring 

stick based on sound principles upon 

which to evaluate such data. Likewise, 

there was no reliable yardstick upon 

which to measure the amount of 

controlled substances reflected in the 

databases compared to what a 

reasonable regulator would expect to see 

regarding a compliant registrant. To the 

extent Langston possessed this 

information (and she well may have) it 

was not elicited from her. The same 

could be said of the allegation set forth 

in the Government’s Prehearing 

Statement that alleges that from a given 

period the Respondent ‘‘was the 20th 

largest practitioner purchaser of 

oxycodone in the United States.’’ 59 No 

evidence to support that allegation (or 

its relevance) was ever brought forth at 

the hearing. To the extent that fact may 

have been true or relevant, it was never 

developed. What’s more, the Florida 

Administrative Code specifically 

eschews pain medication prescribing 

analysis rooted only in evaluation of 

medication quantity. Fla. Admin. Code 

r. 64B8–9.013(g). Lastly, there was no 

indication that despite Langston’s 

obvious qualifications to do so, that she 

or anyone else ever conducted an audit 

of the controlled-substance-inventoryrelated recordkeeping practices at 

American Pain. 

SA Burt testified that, during a 

temporally limited period of time, he 

observed some of the images captured 

by a pole camera positioned outside 

American Pain, and that he observed 

what in his view was a high percentage 

of vehicles in the parking lot with outof-state license tags. This testimony 

arguably provides some support for the 

Government’s contention that out-ofstate patients (or at least patients being 

dropped off by cars with out-of-state 

tags) were being seen at the clinic, but 

his testimony did not provide much else 

in terms of relevant information. In any 

event, recent Agency precedent holds 

that details such as ‘‘where [a 

registrant’s] patients were coming from,’’ 

without additional factual development, 

can support a ‘‘strong suspicion that [a] 

respondent was not engaged in a 

legitimate medical practice’’ but that 

‘‘under the substantial evidence test, the 

evidence must ‘do more than create a 

suspicion of the existence of the fact to 

be established.’ ’’ Alvin Darby, M.D., 75 

FR 26993, 26999, n.31 (2010) (citing 

NLRB v. Columbian Enameling & 

Stamping Co., 306 U.S. 292, 300 (1939). 

Likewise, without additional details 

or at least some context, Burt’s 

testimony that individuals with ‘‘staff’’ 

written on their shirts appeared to be 

directing patients into the clinic reveals 

virtually nothing about the 

Respondent’s prescribing practices. Tr. 

at 818, 910. Furthermore, that Burt 

observed an individual on a videotape, 

who he believed to be an American Pain 

employee, on a single occasion, instruct 

patients not to ‘‘snort [their] pills’’ in the 

parking lot,60 or advising them to 

comply with vehicle and traffic laws,61

does not shed illumination on the 

Respondent’s prescribing practices. 

There was no evidence that the 

Respondent knew that these isolated 

incidents occurred, nor was there 

contextual evidence from which the 

relevance to these proceedings could be 

gleaned. Even if this tribunal was 

inclined to engage in the unsupported 

assignment of motives to the actions of 

these employees, under these 

circumstances, such an exercise could 

not constitute substantial evidence that 

could be sustained at any level of 

appeal. 

Burt’s testimony regarding his 

conversations with Dr. Sollie, who was 

formerly employed by American Pain, 

was also not received in a manner that 

could meaningfully assist in the 

decision process. According to Burt, 

Sollie told him that some (unnamed) 

physicians at American Pain were 

inadequately documenting their patient 

charts in some manner that was 

apparently never explained to Burt,62

and that some patients were 

intentionally evading the American Pain 

urinalysis process. Sollie did not 

specifically name the Respondent or any 

physician as being connected with his 

allegations of misconduct. Tr. at 853. 

Thus, this tribunal is at something of a 

loss as to how the information, as 

presented, would tend to establish a fact 

relevant to whether the continuation of 

the Respondent’s authorization to 

handle controlled substances is in the 

public interest. 

The Government’s evidence targeted 

not only the Respondent’s experience 

practicing under Factor 2, but also his 

compliance with applicable state and 

federal laws relating to controlled 

substances under Factor 4. To effectuate 

the dual goals of conquering drug abuse 

and controlling both legitimate and 

illegitimate traffic in controlled 

substances, ‘‘Congress devised a closed 

regulatory system making it unlawful to 

manufacture, distribute, dispense, or 

possess any controlled substance except 

in a manner authorized by the CSA.’’ 

Gonzales v. Raich, 545 U.S. 1, 13 (2005). 

Consistent with the maintenance of that 

closed regulatory system, subject to 

limited exceptions not relevant here, a 

controlled substance may only be 

dispensed upon a prescription issued by 

a practitioner, and such a prescription is 

unlawful unless it is ‘‘issued for a 

legitimate medical purpose by an 

individual practitioner acting in the 

usual course of his professional 

practice.’’ 21 U.S.C. 829; 21 CFR 

1306.04(a). Furthermore, ‘‘an order 

purporting to be a prescription issued 

not in the usual course of professional 

treatment * * * is not a prescription 

within the meaning and intent of [21 

U.S.C. 829] and the person knowingly 

* * * issuing it, shall be subject to the 

penalties provided for violations of the 

provisions of law related to controlled 

substances.’’ Id. 

A registered practitioner is authorized 

to dispense,63 which the CSA defines as 

‘‘to deliver a controlled substance to an 

ultimate user 64 * * * by, or pursuant to 

the lawful order of a practitioner.’’ 21 

U.S.C. 802(10); see also Rose Mary 

Jacinta Lewis, 72 FR 4035, 4040 (2007). 

The prescription requirement is 

designed to ensure that controlled 

substances are used under the 

supervision of a doctor, as a bulwark 

against the risk of addiction and 

recreational abuse. Aycock, 74 FR at 

17541 (citing Gonzales v. Oregon, 546 

U.S. 243, 274 (2006); United States v. 

Moore, 423 U.S. 122, 135, 142–43 (1975) 

(noting that evidence established that a 

physician exceeded the bounds of 

professional practice when he gave 

inadequate examinations or none at all, 

ignored the results of the tests he did 

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65Rulemaking authority regarding the practice of 

medicine within the State of Florida has been 

delegated to the Florida Board of Medicine (Florida 

Board). Fla. Stat. § 458.309(1) (2009). 

66Florida defines ‘‘intractable pain’’ to mean ‘‘pain 

for which, in the generally accepted course of 

medical practice, the cause cannot be removed and 

otherwise treated.’’ Fla. Stat. § 458.326 (2009). 

67Pursuant to authority vested in the Florida 

Board by the Florida legislature to promulgate rules 

regarding State standards for pain management 

clinical practice specifically. Fla. Stat. § 458.309(5) 

(2009). 

make, and took no precautions against 

misuse and diversion)). The 

prescription requirement likewise 

stands as a proscription against doctors 

‘‘peddling to patients who crave the 

drugs for those prohibited uses.’’ Id. The 

courts have sustained criminal 

convictions based on the issuing of 

illegitimate prescriptions where 

physicians conducted no physical 

examinations or sham physical 

examinations. United States v. Alerre, 

430 F.3d 681, 690–91 (4th Cir. 2005), 

cert. denied, 574 U.S. 1113 (2006); 

United States v. Norris, 780 F.2d 1207, 

1209 (5th Cir. 1986). 

While true that the CSA authorizes 

the ‘‘regulat[ion] of medical practice so 

far as it bars doctors from using their 

prescription-writing powers as a means 

to engage in illicit drug dealing and 

trafficking as conventionally 

understood,’’ Gonzales, 546 U.S. at 266– 

67, an evaluation of cognizant state 

standards is essential. Joseph Gaudio, 

M.D., 74 FR 10083, 10090 (2009); Kamir 

Garces-Mejias, M.D., 72 FR 54931, 

54935 (2007); United Prescription 

Servs., Inc., 72 FR 50397, 50407 (2007). 

In this adjudication, the evaluation of 

the Respondent’s prescribing practices 

must be consistent with the CSA’s 

recognition of state regulation of the 

medical profession and its bar on 

physicians from peddling to patients 

who crave drugs for prohibited uses. 

The analysis must be ‘‘tethered securely’’ 

to state law and federal regulations in 

application of the public interest factors, 

and may not be based on a mere 

disagreement between experts as to the 

most efficacious way to prescribe 

controlled substances to treat chronic 

pain sufferers. Volkman v. DEA, 567 

F.3d 215, 223 (6th Cir. 2009) (citing 

Gonzales, 546 U.S. at 272, 274). 

Under the CSA, it is fundamental that 

a practitioner must establish a bonafide 

doctor-patient relationship in order to 

act ‘‘in the usual course of * * * 

professional practice’’ and to issue a 

prescription for a legitimate medical 

purpose.’’ Stodola, 74 FR at 20731; 

Shyngle, 74 FR at 6057–58 (citing 

Moore, 423 U.S. at 141–43). The CSA 

looks to state law to determine whether 

a bonafide doctor-patient relationship 

existed. Stodola, 74 FR at 20731; 

Shyngle, 74 FR at 6058; Garces-Mejias, 

72 FR at 54935; United Prescription 

Servs., 72 FR at 50407. It was Dr. 

Kennedy’s uncontroverted opinion that 

his evaluation of chart entries 

convinced him that they were so 

defective that the Respondent did not 

establish a sufficient doctor-patient 

relationship to justify the prescribing of 

controlled substances, and that ‘‘this 

was not the practice of medicine in [his] 

opinion.’’ Tr. at 160–61. 

Under Florida law, grounds for 

disciplinary action or denial of state 

licensure include ‘‘prescribing * * * 

any controlled substance, other than in 

the course of the physician’s 

professional practice,’’ and prescribing 

such substances ‘‘inappropriately or in 

excessive or inappropriate quantities is 

not in the best interest of the patient and 

is not in the course of the physician’s 

professional practice, without regard to 

his or her intent.’’ Fla. Stat. § 458.331(q) 

(2009). Florida law further provides that 

grounds for such disciplinary action 

also include: 

Failing to keep legible, as defined by 

department rule in consultation with the 

board, medical records that identify the 

licensed physician * * * and that justify the 

course of treatment of the patient, including, 

but not limited to, patient histories; 

examination results; test results; records of 

drugs prescribed, dispensed, or administered; 

and reports of consultations and 

hospitalizations. 

Id. § 458.331(m). 

In exercising its rulemaking 

function,65 the Florida Board of 

Medicine (Florida Board) promulgated a 

regulation addressing ‘‘Standards for 

Adequacy of Medical Records’’ 

applicable to all physicians. Fla. Admin. 

Code r. 64B8–9.003 (2009). That 

regulation provides, in pertinent part: 

(2) A licensed physician shall maintain 

patient medical records in English, in a 

legible manner and with sufficient detail to 

clearly demonstrate why the course of 

treatment was undertaken. 

(3) The medical record shall contain 

sufficient information to identify the patient, 

support the diagnosis, justify the treatment 

and document the course and results of 

treatment accurately, by including, at a 

minimum, patient histories; examination 

results; test results; records of drugs 

prescribed, dispensed or administered; 

reports of consultations and hospitalizations; 

and copies of records or reports or other 

documentation obtained from other health 

care practitioners at the request of the 

physician and relied upon by the physician 

in determining the appropriate treatment of 

the patient. 

(4) All entries made into the medical 

records shall be accurately dated and timed. 

Late entries are permitted, but must be 

clearly and accurately noted as late entries 

and dated and timed accurately when they 

are entered in to the record * * *. 

Fla. Admin. Code r. 64B8–9.003 (2009). 

With respect to defining the 

parameters of what constitutes 

‘‘professional practice’’ in the context of 

pain management prescribing, Florida 

state law provides: 

Notwithstanding any other provision of 

law, a physician may prescribe or administer 

any controlled substance under Schedules II– 

V * * * to a person for the treatment of 

intractable pain,66 provided the physician 

does so in accordance with that level of care, 

skill, and treatment recognized by a 

reasonably prudent physician under similar 

conditions and circumstances. 

Fla. Stat. § 458.326 (2009). Moreover, 

the Florida Board has adopted,67 albeit 

in modified version, the Model Policy 

for the Use of Controlled Substances for 

the Treatment of Pain (Model Policy), a 

document drafted by the Federation of 

State Medical Boards (FSMB) to provide 

professional guidelines for the treatment 

of pain with controlled substances. The 

standards adopted by Florida share the 

key tenants of the Model Policy’s 

standards for pain management 

prescribing, including the emphasis on 

diligent efforts by physicians to prevent 

drug diversion, prescribing based on 

clear documentation of unrelieved pain 

and thorough medical records, and 

compliance with applicable Federal and 

State law. 

Like the Model Policy, which was 

promulgated ‘‘to encourage the 

legitimate medical uses of controlled 

substances for the treatment of pain 

while stressing the need to safeguard 

against abuse and diversion,’’ Florida’s 

regulation providing ‘‘Standards for the 

Use of Controlled Substances for 

Treatment of Pain,’’ Fla. Admin. Code r. 

64B8–9.013 (2009) (Florida Standards), 

recognizes that ‘‘inappropriate 

prescribing of controlled substances 

* * * may lead to drug diversion and 

abuse by individuals who seek them for 

other than legitimate medical use.’’ The 

language employed by the regulation 

under the preamble section titled ‘‘Pain 

Management Principles’’ makes clear 

that the standards ‘‘are not intended to 

define complete or best practice, but 

rather to communicate what the [Florida 

Board] considers to be within the 

boundaries of professional practice’’ 

(emphasis supplied), id. at 9.013(1)(g); 

thus, the plain text supports an 

inference that the standards provide the 

minimum requirements for establishing 

conduct that comports with the 

professional practice of controlled 

substance-based pain management 

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68 21 CFR 1306.04(a). 

69The original Model Policy version of the 

guidelines does not contain a reference to the need 

for a complete medical history, instead only 

requiring a medical history generally. Thus, the 

Florida Board has adopted a higher standard than 

the measure that has been set in the Model Policy 

by the FSMB. 

within the state. Likewise, the level of 

integral range of acceptable practice that 

is built into the regulation underscores 

the importance of seeking an expert 

professional opinion in reaching a 

correct adjudication of whether a 

registrant has met the applicable Florida 

standard. It is clear that in assessing 

whether the controlled substance 

prescribing practices of a Florida 

practitioner fall within the acceptable 

range of what constitutes being within 

the bounds of being ‘‘issued for a 

legitimate medical purpose by an 

individual practitioner acting in the 

usual course of his professional 

practice,’’ 68 resort must be had to an 

expert. 

The Florida Standards direct that 

‘‘[p]hysicians should be diligent in 

preventing the diversion of drugs for 

illegitimate purposes,’’ id. at 9.013(1)(d), 

and provide that the prescribing of 

controlled substances for pain will be 

considered 

to be for a legitimate medical purpose if 

based on accepted scientific knowledge of 

the treatment of pain or if based on sound 

clinical grounds. All such prescribing must 

be based on clear documentation of 

unrelieved pain and in compliance with 

applicable state or federal law. 

Id. at 9.013(1)(e) (emphasis supplied). 

The Florida Standards further provide 

that the validity of prescribing will be 

judged ‘‘based on the physician’s 

treatment of the patient and on available 

documentation, rather than on the 

quantity and chronicity of prescribing’’ 

(emphasis supplied). Id. at 9.013(1)(g). 

Furthermore, the Standards advise that 

physicians should not fear disciplinary 

action for ‘‘prescribing controlled 

substances * * * for a legitimate 

medical purpose and that is supported 

by appropriate documentation 

establishing a valid medical need and 

treatment plan’’ (emphasis supplied), or 

‘‘for failing to adhere strictly to the 

provisions of these standards, if good 

cause is shown for such deviation’’ 

(emphasis supplied). Id. at 

9.013(1)(b),(f). 

Although, as discussed above, the 

Florida Board instituted general 

guidance applicable to all physicians 

regarding medical records, it also 

promulgated a separate set of 

documentation requirements in the 

Florida Standards applicable 

specifically to those physicians who 

prescribe controlled substances in the 

pain-management context. The Florida 

Standards, under the subheading 

‘‘Medical Records,’’ state that ‘‘[t]he 

physician is required to keep accurate 

and complete records’’ (emphasis 

supplied) including, though not limited 

to: 

1. The medical history and physical 

examination, including history of drug 

abuse or dependence, as appropriate; 

2. Diagnostic, therapeutic, and 

laboratory results; 

3. Evaluations and consultations; 

4. Treatment objectives; 

5. Discussion of risks and benefits; 

6. Treatments; 

7. Medications (including date, type, 

dosage, and quantity prescribed); 

8. Instructions and agreements; and 

9. Periodic reviews. 

Id. at 9.013(3)(f). The same section 

directs that ‘‘[r]ecords must remain 

current and be maintained in an 

acceptable manner and readily available 

for review. Id. 

The Florida Standards similarly 

emphasize the need for proper 

documentation in the patient evaluation 

context by specifying: 

A complete 69 medical history and physical 

examination must be conducted and 

documented in the medical record. The 

medical record should document the nature 

and intensity of the pain, current and past 

treatments for pain, underlying or coexisting 

diseases or conditions, the effect of the pain 

on physical and psychological function, and 

history of substance abuse. The medical 

record also should document the presence of 

one or more recognized medical indications 

for the use of a controlled substance. 

Id. at 9.013(3)(a). 

Furthermore, the Florida Standards 

require a written treatment plan that 

‘‘should state objectives that will be 

used to determine treatment success, 

such as pain relief and improved 

physical and psychosocial function, and 

should indicate if any further diagnostic 

evaluations or other treatments are 

planned.’’ Id. at 9.013(3)(b). Subsequent 

to the initiation of treatment, ‘‘the 

physician should adjust drug therapy to 

the individual medical needs of each 

patient. Other treatment modalities or a 

rehabilitation program may be necessary 

depending on the etiology of the pain 

and the extent to which the pain is 

associated with physical and 

psychosocial impairment.’’ (emphasis 

supplied). Id. 

Another standard adopted by the 

Florida Board, under the subheading 

‘‘Informed Consent and Agreement for 

Treatment,’’ is the directive that 

[t]he physician should discuss the risks and 

benefits of the use of controlled substances 

with the patient, persons designated by the 

patient, or with the patient’s surrogate or 

guardian if the patient is incompetent. The 

patient should receive prescriptions from one 

physician and one pharmacy where possible. 

If the patient is determined to be at high risk 

for medication abuse or have a history of 

substance abuse, the physician should 

employ the use of a written agreement 

between the physician and patient outlining 

patient responsibilities, including, but not 

limited to: 

1. Urine/serum medication levels screening 

when requested; 

2. Number and frequency of all 

prescription refills; and 

3. Reasons for which drug therapy may be 

discontinued (i.e., violation of agreement). 

Id. at 9.003(3)(c). 

The Florida Standards contain a 

further requirement to periodically 

review ‘‘the course of pain treatment and 

any new information about the etiology 

of the pain or the patient’s state of 

health.’’ Id. at 9.013(3)(d). The Florida 

Standards explain the importance of 

periodic review in the following 

manner: 

Continuation or modification of therapy 

depends on the physician’s evaluation of the 

patient’s progress. If treatment goals are not 

being achieved, despite medication 

adjustments, the physician should reevaluate 

the appropriateness of continued treatment. 

The physician should monitor patient 

compliance in medication usage and related 

treatment plans. 

Id. 

Under the subheading ‘‘Consultation,’’ 

the Florida Board promulgated the 

instruction that 

[t]he physician should be willing to refer 

the patient as necessary for additional 

evaluation and treatment in order to achieve 

treatment objectives. Special attention should 

be given to those pain patients who are at 

risk for misusing their medications and those 

whose living arrangements pose a risk for 

medication misuse or diversion. The 

management of pain in patients with a 

history of substance abuse or with a 

comorbid psychiatric disorder requires extra 

care, monitoring, and documentation, and 

may require consultation with or referral to 

an expert in the management of such 

patients. 

Id. at 9.003(3)(e). 

It is abundantly clear from the plain 

language of the Florida Standards that 

the Florida Board places critical 

emphasis on physician implementation 

of adequate safeguards in their practice 

to minimize diversion and the need to 

document the objective signs and 

rationale employed in the course of pain 

treatment utilizing the prescription of 

controlled substances. Conscientious 

documentation is repeatedly 

emphasized as not just a ministerial act, 

but a key treatment tool and a vital 

indicator to evaluate whether the 

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Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices 19449 

70Respondent, in his brief, correctly points out 

that (for reasons not readily apparent) the 

Government elicited no testimony from Dr. 

Kennedy regarding any patient treated by the 

Respondent. Respt’s Br. at 10–11. 

71Likewise, contrary to the position taken by the 

Respondent in his brief (Respt’s Br. at 7), Dr. 

Kennedy’s opinions are not invalidated by the size 

of the representative sample of files he reviewed or 

the manner in which they were selected. Firstly, SA 

Langston provided credible testimony regarding the 

selection process, which although admittedly not a 

paradigm of scientific sampling methodology, was 

likewise not designed to achieve a particular result. 

Secondly, contrary to the assertion in the 

Respondent’s brief (Respt’s Br. at 15), there is no 

baseline magic number of files or registrant actions 

that must be examined to support an expert opinion 

and ultimately an Agency determination as to 

whether a registrant has committed acts 

inconsistent with the public interest sufficient to 

merit adverse action relative to a DEA COR. See 

Krishna-Iyer, 74 FR at 464. 

physician’s prescribing practices are 

‘‘within the usual course of professional 

practice.’’ Here, the uncontroverted 

expert opinion of Dr. Kennedy, the only 

expert opinion presented 70 in these 

proceedings, reflects that the 

documentation he reviewed in the 

Respondent’s patient charts reflected 

care that was markedly below the 

standard of care set by the Florida 

Medical Board. Dr. Kennedy’s expert 

assessment was consistent with the state 

statutory and regulatory guidance. In 

Kennedy’s view, the Respondent’s 

charts demonstrated minimalistic, 

incomplete, and otherwise medically 

inadequate documentation of his 

contacts with his patients, and the 

prescribing rationale for his issuance of 

controlled substance prescriptions to 

those patients for alleged pain 

management purposes. The boilerplatestyle, ‘‘one high-dosage controlled 

substances treatment plan fits all’’ 

nature of nearly all of the patient 

medical records at issue, at least in the 

view of the uncontroverted expert, 

evidences a failure on the part of the 

Respondent to conduct his practice of 

medicine in a manner to minimize the 

potential of controlled substance abuse 

and diversion, and supports a 

conclusion that he failed to even 

substantially comply with the minimum 

obligations for professional practice 

imposed under the Florida Standards, 

and without ‘‘good cause [] shown for 

such deviation.’’ Id. at 9.013(1)(f). 

In his Post-Hearing Brief 

(Respondent’s Brief), the Respondent’s 

counsel has prepared and submitted a 

thoughtful and detailed review of one of 

the patient charts that was analyzed by 

Dr. Kennedy in his report. Respt’s Br. at 

22–26. While counsel argues that the 

patient chart entries were, at least by his 

interpretation of his client’s obligations, 

satisfactory, the expert’s opinion at the 

hearing remained unchanged. Even 

acknowledging, as this recommended 

decision does, that Dr. Kennedy’s 

presentation was not without its 

deficiencies, its shortcomings do render 

it so fundamentally defective as to 

completely undermine his credibility 

and viability as within the scope of 

what a litigant may depend upon.71 As 

recognized in the Respondent’s Brief, 

‘‘the [G]overnment, like any party in a 

contested hearing, is free to hire an 

expert to advocate its position.’’ Respt’s 

Br. at 12. Unfortunately, counsel’s 

analysis of the patient chart prepared by 

the Respondent is the product of a lay 

evaluation of standards applicable to the 

nuanced and sophisticated science that 

is the practice of medicine. Where his 

opinion and that of the only accepted 

medical expert to provide an expert 

opinion conflict, his opinion cannot and 

will not be afforded controlling 

deference. Argument supplied by 

counsel (albeit a diligent and persuasive 

counsel) that the relevant standards 

were satisfactorily applied as evidenced 

by the protocols and procedures 

documented in the patient charts cannot 

supplant the unrefuted view of an 

accepted expert witness. 

The Respondent, who was in a unique 

position to conclusively refute Dr. 

Kennedy’s views and explain the format 

and nuances of the reviewed 

documentation, elected not to testify in 

this matter. At a DEA administrative 

hearing, it is permissible to draw an 

adverse inference from the silence of the 

Respondent, even in the face of a Fifth 

Amendment invocation. Hoxie v. DEA, 

419 F.3d 477, 483 (6th Cir. 2005) (citing 

United States v. Hale, 422 U.S. 171, 176 

(1975) (‘‘silence gains more probative 

weight where it persists in the face of 

accusation, since it is assumed in such 

circumstances that the accused would 

be more likely than not to dispute an 

untrue accusation.’’)); Joseph 

Baumstarck, M.D., 74 FR 17525, 17528, 

n.3 (2009) (citing Ohio Adult Parole 

Auth. v. Woodward, 523 U.S. 272, 286 

(1998)). On the facts of this case, where 

the allegations are of a nature that a 

registrant would be more likely than not 

to dispute them if untrue, an adverse 

inference based on the Respondent’s 

silence is appropriate. Where, as here, 

the Government, through its expert, has 

alleged that the Respondent’s charts do 

not reflect genuine analysis, but rather 

(at least in its view and the opinion of 

its expert), a sort of sham-by-check-box 

form designed specifically to present a 

false impression of a compliant 

registrant, it is precisely the type of 

allegation that would naturally all but 

oblige a registrant to spring to offer a 

contradictory account. The 

Respondent’s choice to remain silent in 

the face of such allegations, where he 

could have related his version of his 

practice as a registrant, adds at least 

some additional credence to the factual 

and analytical views of the 

Government’s expert in this regard. 

In the Social Security context, where 

an Administrative Law Judge has 

received Expert medical opinions on the 

issue of the claimant’s ability to work 

and they are not repudiated in any 

respect by substantial evidence, an 

adverse decision should be set aside as 

based on ‘‘suspicion and speculation.’’ 

Miracle v. Celebrezze, 351 F.2d 361, 378 

(6th Cir. 1965); see also Hall v. 

Celebrezze, 314 F.2d 686, 689–90 (6th 

Cir. 1963); cf. Harris v. Heckler, 756 

F.2d 431, 436 (6th Cir. 1985) (improper 

to reject uncontroverted evidence 

supporting complaints of pain simply 

because of claimant’s demeanor at 

hearing). When an administrative 

tribunal elects to disregard the 

uncontradicted opinion of an expert, it 

runs the risk of improperly declaring 

itself as an interpreter of medical 

knowledge. Ross v. Gardner, 365 F.2d 

554 (6th Cir. 1966). While in this case 

it is ironically true, much like in the 

Social Security context, that the opinion 

of a treating physician should be 

afforded greater weight than the opinion 

of an expert whose opinion is limited to 

a review of the patient file, see 

Magallenes v. Bowen, 881 F.2d 747, 751 

(9th Cir. 1989), the treating-source 

Respondent in this case offered no 

evidence, not even his own opinion, 

regarding the treatment rendered. Thus, 

in this adjudication, the record contains 

no dispute between experts to be 

resolved; instead, there is but one, 

unrefuted, uncontroverted, credible 

expert opinion. To ignore that expert 

opinion on this record and replace it 

with the opinion of this tribunal, 

Respondent’s counsel, or any other lay 

source would be a dangerous course and 

more importantly, a plainly erroneous 

one. 

Accordingly, after carefully balancing 

the admitted evidence, the evidence 

establishes, by a preponderance, that the 

prescriptions the Respondent issued in 

Florida were not issued within ‘‘the 

usual course of [the Respondent’s] 

professional practice.’’ 21 CFR 

1306.04(a). Consideration of the 

evidence under the second and fourth 

factors support the COR revocation 

sought by the Government in this case. 

To the extent that the Respondent’s 

prescribing practices fell below the 

requisite standard in Florida, that 

conduct also impacts upon the Fifth 

statutory factor. Under Factor 5, the 

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19450 Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices 

1All citations to the ALJ’s Decision (ALJ) are to 

the slip opinion as issued on August 10, 2010, and 

not to the attached decision which has been 

reformatted. 

2The ALJ found that there is ‘‘no evidence that 

the Respondent ‘prescribe[d] and dispense[d] 

inordinate amounts of controlled substances.’’ ALJ 

at 27. While there is no evidence as to the amounts 

Respondent may have dispensed directly, there is 

such evidence, which is unrefuted, with respect to 

her prescriptions. The Government’s Expert 

specifically found that Respondent ‘‘prescribed very 

high initial and subsequent doses of oxycodone and 

Xanax to [R.A.] excessively and inappropriately 

without adequate medical justification.’’ GX 55, at 

9 (emphasis added). The Government’s Expert 

further noted that ‘‘[t]he typical Xanax (alprazolam) 

starting dose is 0.25 to 0.5 mg. once to twice per 

day,’’ yet Respondent prescribed ‘‘high dose[s] of 

Xanax’’ 2 mg. ‘‘once to three times per day to 12 of 

the 13 ‘patients’ whose files [he] reviewed’’ without 

‘‘consider[ing] many important factors that cause 

anxiety’’ and any ‘‘previous medical evaluation’’; she 

also not refer these patients ‘‘to a mental health 

professional for evaluation.’’ Id. at 10. The Expert 

thus concluded that ‘‘[t]he treatment was with a 

very high dose of the controlled substance Xanax’’ 

and ‘‘was clearly not within the boundaries of 

professional practice.’’ Id. Finally, the Expert 

provided unrefuted evidence that Respondent 

prescribed ‘‘drug cocktails’’ of oxycodone and 

Xanax, which ‘‘were clearly not for any legitimate 

medical purpose.’’ Id. at 13. I thus reject the ALJ’s 

finding to the extent that it states that there was no 

evidence that Respondent prescribed inordinate 

amounts. 

3 I do not, however, adopt the ALJ’s discussion of 

the standards applied by the Agency in assessing 

a practitioner’s experience in dispensing controlled 

substances, which cites cases involving list 

chemical I distributors, a different category of 

registrant. See ALJ Dec. at 26–27. As the Agency has 

previously made clear, DEA can revoke based on a 

single act of intentional diversion and ‘‘evidence 

that a practitioner has treated thousands of patients’’ 

in circumstances that do not constitute diversion 

‘‘does not negate a prima facie showing that the 

practitioner has committed acts inconsistent with 

the public interest.’’ Jayam Krishna-Iyer, 74 FR 459, 

463 (2009). See also Dewey C. MacKay, 75 FR49956, 

49977 (2010); Medicine Shoppe-Jonesborough, 73 

FR 364, 386 & n.56 (noting that pharmacy ‘‘had 

17,000 patients,’’ but that ‘‘[n]o amount of legitimate 

dispensings can render * * * flagrant violations 

[acts which are] ‘consistent with the public 

interest’ ’’), aff’d, Medicine Shoppe-Jonesborough v. 

DEA, 300 Fed. Appx. 409 (6th Cir. 2008). As I 

further explained, ‘‘[w]hile such evidence may be 

[entitled to] some weight in assessing whether a 

practitioner has credibly shown that [he] has 

reformed his practices,’’ it is entitled to no weight 

where a practitioner fails to acknowledge her 

wrongdoing. Krishna-Iyer, 74 FR at 463. 

In any event, Respondent offered no evidence on 

the issue of his experience in dispensing controlled 

substances and the ALJ’s ultimate conclusion that 

Respondent violated the CSA’s prescription 

requirement because she dispensed controlled 

substance prescriptions that were not ‘‘within ‘the 

usual course of [her] professional practice,’ ’’ ALJ at 

39 (quoting 21 CFR 1306.04(a)), and that ‘‘the 

evidence under the [experience] * * * factor[] 

support[s]’’ the revocation of her registration, is 

consistent with Agency precedent. Id. at 40. 

With respect to factor five, ‘‘[s]uch other conduct 

which may threaten public health and safety,’’ 21 

U.S.C. 823(f)(5), the ALJ opined that ‘‘an adverse 

finding under this factor requires some showing 

that the relevant conduct actually constituted a 

threat to public safety.’’ ALJ at 40 (emphasis added). 

Contrary to the ALJ’s reasoning, Congress, by 

inserting the word ‘‘may’’ in factor five, clearly 

manifested its intent to grant the Agency authority 

to consider conduct which creates a probable or 

possible threat (and not only an actual) threat to 

public health and safety. See Webster’s Third New 

Int’l Dictionary 1396 (1976) (defining ‘‘may’’ in 

relevant part as to ‘‘be in some degree likely to’’); 

see also The Random House Dictionary of the 

English Language 1189 (1987) (defining ‘‘may’’ in 

relevant part as ‘‘used to express possibility’’). While 

the ALJ misstated the applicable standard, his 

conclusion that Respondent repeatedly ignored ‘‘red 

flags’’ indicative of likely diversion and thus 

‘‘created a significant potential conduit for the 

unchecked diversion of controlled substances’’ is 

clearly supported by substantial evidence and 

warrants an adverse finding under factor five. Id. at 

41. 

Deputy Administrator is authorized to 

consider ‘‘other conduct which may 

threaten the public health and safety.’’ 

21 U.S.C. 823(f)(5). Although this factor 

authorizes consideration of a somewhat 

broader range of conduct reaching 

beyond those activities typically 

associated with a registrant’s practice, 

an adverse finding under this factor 

requires some showing that the relevant 

conduct actually constituted a threat to 

public safety. See Holloway Distrib., 72 

FR 42118, 42126 (2007). 

The evidence establishes that the 

Respondent engaged in a course of 

practice wherein he prescribed 

controlled substances to patients 

irrespective of the patients’ need for 

such medication and ignoring any and 

red flags that could or did indicate 

likely paths of diversion. The testimony 

of Dr. Kennedy, the DEA regulations, 

and the Florida Standards make clear 

that physicians prescribing controlled 

substances do so under an obligation to 

monitor the process to minimize the risk 

of diversion. The patient charts reflect 

that the Respondent, contrary to his 

obligations as a DEA registrant, did not 

follow up in the face of multiple red 

flags. The Respondent’s disregard of his 

obligations as a DEA registrant and 

Federal and state laws related to 

controlled substances militate in favor 

of revocation. 

By ignoring his responsibilities to 

monitor the controlled substance 

prescriptions he was authorizing to 

minimize diversion, and by 

participating in an insufficiently 

documented and thoughtful process for 

the issuance of potentially dangerous 

controlled substances, the Respondent 

created a significant potential conduit 

for the unchecked diversion of 

controlled substances. See Holloway 

Distrib., 72 FR at 42124 (a policy of ‘‘see 

no evil, hear no evil’’ is fundamentally 

inconsistent with the obligations of a 

DEA registrant). Agency precedent has 

long recognized that ‘‘[l]egally, there is 

absolutely no difference between the 

sale of an illicit drug on the street and 

the illicit dispensing of a licit drug by 

means of a physician’s prescription.’’ 

EZRX, LLC, 69 FR 63178, 63181 (1988); 

Floyd A. Santner, M.D., 55 FR 37581 

(1988). 

Agency precedent has consistently 

held that where, as here, the 

Government has met its burden to 

establish a prima facie case that a 

registrant has committed acts 

demonstrating that continued 

registration is inconsistent with the 

public interest, acceptance of 

responsibility is a condition precedent 

to continued registration. Jeri Hassman, 

M.D., 75 FR 8194, 8236 (2010); Medicine 

Shoppe, 73 FR at 387. The record 

contains no evidence that the 

Respondent has either acknowledged or 

accepted responsibility for the 

misconduct at issue in these 

proceedings. 

Recommendation 

Based on the foregoing, the evidence 

supports a finding that the Government 

has established that the Respondent has 

committed acts that are inconsistent 

with the public interest. A balancing of 

the statutory public interest factors 

supports the revocation of the 

Respondent’s Certificate of Registration 

and a denial of his application to renew. 

The Respondent has not accepted 

responsibility for his actions, expressed 

remorse for his conduct at any level, or 

presented evidence that could 

reasonably support a finding that the 

Deputy Administrator should continue 

to entrust him with a Certificate of 

Registration. Accordingly, the 

Respondent’s Certificate of Registration 

should be revoked and any pending 

applications for renewal should be 

denied. 

Dated: August 10, 2010. 

John J. Mulrooney, II, 

U.S. Administrative Law Judge. 

[FR Doc. 2011–8345 Filed 4–6–11; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 10–34] 

Cynthia M. Cadet, M.D.; Decision and 

Order 

On August 10, 2010, Administrative 

Law Judge (ALJ) John J. Mulrooney, II, 

issued the attached recommended 

decision.1 The Respondent did not file 

exceptions to the decision. 

Having reviewed the entire record 

including the ALJ’s recommended 

decision, I have decided to adopt the 

ALJ’s rulings, findings of fact,2

conclusions of law,3 and recommended 

Order. 

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