19420 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 

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. 

4Pursuant to an order issued on April 15, 2010, 

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. 

5A schedule II controlled substance. 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 10–40] 

Michael J. Aruta, 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 record in its 

entirety 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. 

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, 

BA6733578, issued to Michael J. Aruta, 

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

further order that any pending 

application of Michael J. Aruta, 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. 

Bernard M. Cassidy., 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 

BA6733578, of Michael J. Aruta, 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 seeks 

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 24, 2010, the Respondent timely 

requested a hearing, which was 

conducted in Miami, Florida, on July 7, 

2010 through July 9, 2010.4 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, 2012. 

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 had been conducting at 

American Pain, LLC (American Pain), 

has prescribed and dispensed inordinate 

amounts of controlled substances, 

primarily oxycodone,5 under 

circumstances wherein he knew, or 

should have known, that the controlled 

substances were not prescribed and/or 

dispensed for a legitimate medical 

purpose. ALJ Ex. 1. The OSC/ISO 

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6The majority of which are supported by no 

evidence introduced by the Government during the 

course of these proceedings. 7Although 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. 

8 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. 

9Although 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. 

10 GS Langston explained that through the 

ARCOS system, ‘‘[d]rug manufacturers and 

distributors are required to report the sale of certain 

controlled substances to DEA,’’ and the system 

‘‘shows the history of a drug from the point of 

manufacture through the distribution chain to the 

retail dispensing level.’’ Tr. at 685–86. 

11For reasons that were never made clear, the 

ARCOS report begins with a 2006 entry. Govt. Ex. 

2 at 1. 

further charges that these prescriptions 

were issued outside the usual course of 

professional practice based on a variety 

of circumstances 6 surrounding the 

manner in which American Pain has 

been operated and the manner in which 

its physicians, to include the 

Respondent, has engaged in the practice 

of medicine. Id. The OSC/ISO also sets 

forth the Government’s allegation 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 

little or no medical examination.’’ Id. 

At the hearing, the Government 

presented the testimony of three 

witnesses, DEA Miami Field Division 

(MFD) Group Supervisor (GS) Susan 

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.7 Id. at 721. Under 

Langston’s supervision, DEA diversion 

investigators catalogued the 

prescriptions seized at Boca Drugs (Boca 

Drugs Prescription Log). Govt. Ex. 118. 

A review of the data relative to the 

Respondent on the Boca Drug 

Prescription Log reveals that from 

November 2, 2009 through November 

25, 2009, 175 controlled substance 

prescriptions issued over the 

Respondent’s signature, to eighty-nine 

patients, only five of whom resided in 

Florida. The remainder of the patients 

had listed addresses in Kentucky, 

Tennessee, Ohio, Georgia, 

Massachusetts, West Virginia, North 

Carolina, Virginia, and South Carolina. 

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. Tr. 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 8 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.9 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) 10 and 

testified that she generated an ARCOS 

report relative to the Respondent’s 

ordering of controlled substances from 

January 2009 through February 2010.11

Govt. Ex. 2. 

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 and 

Kentucky. Govt. Exs. 3, 4. Review of the 

PMP report data reflects that during the 

time period of February 1, 2006 through 

February 11, 2010, pharmacies filled 

210 controlled substance prescriptions 

issued over the Respondent’s signature 

to fifty-five patients located in West 

Virginia, and 182 similar prescriptions 

provided to seventy-eight Kentuckybased patients were filled between 

January 1, 2009 and April 4, 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 

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12SA 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. 

13Tr. at 910. 

14SA 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. 

15Later on cross-examination, SA Burt admitted 

that the clinic also accepted payment via credit 

card. Tr. at 916. 

16 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. 

17Burt 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. To proceed 

otherwise would deny the Respondent the ability 

guaranteed by the APA ‘‘to conduct such crossexamination 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). 

18Tr. at 1002–05. 

19The 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. 

20On cross-examination, SA Burt stated that he 

did not know whether it was true that the 

Respondent began working at the clinic in 2009 (a 

representation made by Respondent’s counsel, but 

not in evidence), which (at least according to the 

question posed) would have been after Sollie’s 

employment at the clinic had already ended. Tr. at 

898. 

of the data set forth in any of these 

databases to any issue that must or 

should be considered in deciding the 

present case. 

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 

he surveilled the Boca Raton and Lake 

Worth locations both in person and by 

periodic live review of video captured 

via pole cameras 12 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 13 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) 14 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’’ 15 for these office visits, and the 

six doctors at the clinic saw ‘‘anywhere 

from 200 upward to 375 patients a 

day’’ 16 in this manner.17 Id. at 882–83 

(emphasis supplied). 

SA Burt also testified regarding his 

review of some 18 of the video and audio 

recordings made by an undercover agent 

(UC) who assumed the name Luis Lopez 

capturing activity inside of American 

Pain.19 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.20 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 

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21On cross-examination, SA Burt responded in 

the negative when asked if he had ‘‘anywhere’’ in 

his possession a copy of the prescription at issue 

and whether he had supplied Government counsel 

with a copy of this individual’s patient file. Tr. at 

894. 

22 In light of the inability to identify the name of 

this source of information to opposing counsel, and 

the lack of detail and corroborating evidence related 

to the information derived from her, no weight can 

be assigned to SA Burt’s testimony concerning 

information provided by CS2, beyond the fact that 

this interaction may have informed the course of 

DEA’s investigation. 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). 

23Although 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. 

24According 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. 

25See Tr. at 836–53 (addressing exclusion of 

Govt. Ex. 27 and associated testimony). 

26ALJ Ex. 6. 

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

Govt. Ex. 117. 

28Tr. at 17. 

29 Dr. Kennedy testified that he asked that the 

charts be selected randomly and not be ‘‘cherry 

picked’’ or selected with a view towards influencing 

his conclusions. Tr. at 214. As discussed, above, GS 

Langston testified that the reviewed charts were not 

selected with a view toward influencing Dr. 

Kennedy’s opinion. Tr. at 768. 

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, Burt testified 

concerning his April 2009 debriefing of 

a confidential source of information 

(CS2) based in Kentucky who came to 

Burt’s attention through his Kentucky 

law enforcement contacts. Id.at 866–67. 

Burt assisted the source’s Kentucky 

handlers with arranging for CS2 to visit 

American Pain, at which time she was 

able to obtain a prescription for 

oxycodone from the Respondent. Burt 

testified that during the debriefing, CS2 

told him the Respondent instructed her 

‘‘not to go out of the State of Florida and 

try to get this pain medication 

[prescription] filled,’’ and that it should 

instead be filled within Florida. Id. at 

869. According to Burt, CS2 also 

indicated that she did not have a 

legitimate medical need for the 

controlled substances when they were 

acquired from the Respondent. The 

Government did not submit evidence of, 

or provide opposing counsel access to, 

a patient file reflecting CS2’s visit with 

the Respondent, or a copy of the 

prescription allegedly issued.21 Burt 

indicated CS2’s cooperation in this 

investigation was as a result of ‘‘working 

off’’ criminal charges she was subject to. 

Id. at 895. Burt also declined to disclose 

the name of CS2 when queried on crossexamination. Id. at 893.22

SA Burt also testified regarding the 

drug overdose deaths of TY and SM 

after obtaining controlled substances 

from American Pain.23 Burt’s record 

testimony indicates that DEA Task 

Force Officer 24 (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.25 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.26

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.27 Dr. Kennedy, who testified 

that he is board certified by the 

American Board of Pain Medicine and 

the American Board of 

Anesthesiology,28 was offered and 

accepted as an expert in the field of pain 

medicine. Tr. at 39. 

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 during his testimony. Govt. Ex. 

5. The report describes a general 

analysis of fifteen charts that the 

Respondent maintained on as many 

patients, that were (selected by and) 

provided to Dr. Kennedy by the 

Government 29 from among an 

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30Tr. at 74. 

31Tr. at 96. 32Tr. at 59. 33 Dr. Kennedy testified that the recommended 

starting dosages are found in the medication 

product insert and divined through clinical 

knowledge. Tr. at 100. 

unspecified number of patient files 

seized pursuant to a criminal search 

warrant executed at the Respondent’s 

practice on March 3, 2010 (Patient 

Charts Analysis). 

In Dr. Kennedy’s expert opinion, 

based on a documentary review of the 

patient charts from the Respondent’s 

practice that he reviewed, the 

Respondent’s prescribing practices fell 

below the standards set forth by the 

Florida Medical Board. Tr. at 118. 

Furthermore, Dr. Kennedy testified that 

after reviewing the charts, he was 

unable to identify any legitimate basis 

for prescribing any of the controlled 

substance medications prescribed to the 

patients named in the charts. Id. 

During the course of his testimony, 

Dr. Kennedy explained that he 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 

testimony. That being said, Dr. Kennedy 

highlighted numerous features in the 

Respondent’s chart documentation that 

he found wanting, or at least 

remarkable. 

While acknowledging that some 

standardization and utilization of forms 

is not, standing alone, improper,30 Dr. 

Kennedy took issue with what he 

perceived as flaws in the forms utilized 

by the Respondent to document patient 

care. According to Dr. Kennedy, the 

forms inadequately distinguished 

between the history and physical 

examinations, and failed to sufficiently 

document an adequate pain assessment. 

Id. at 79–80, 128–31. According to Dr. 

Kennedy, the charts also did not 

document activities that improved or 

exacerbated pain symptoms, and did not 

document self-described patient limits, 

neurological signs and objective 

observations, such as gait and station. 

Id. at 81. Dr. Kennedy testified that the 

chart entries 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. Id. 

at 160–61. 

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 44. 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 47–48. 

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 49– 

51. Although the Respondent’s charts 

routinely contained a form which 

purports to require patients to see their 

primary care physicians, Dr. Kennedy 

testified that none of the files contained 

any record of any communication with 

any primary care physician from any 

patient. Id. at 114–16. 

Kennedy also explained the 

importance of establishing a differential 

or working diagnosis on the first visit 

and modifying and reviewing that 

diagnosis as more information and 

results become available. Id. at 52. 

Similarly, a diagnostic plan is a 

systematic methodology of eliminating 

possible causes of symptoms to allow 

the treating physician to accurately 

determine what is causing them so that 

a successful treatment plan can be 

developed. Id. at 52–53. In other words, 

the diagnostic plan allows the treating 

doctor to eliminate or confirm items on 

the differential diagnosis. Id. at 54. 

Dr. Kennedy testified that, in his 

expert opinion, the medical histories 

taken by the Respondent in the 

reviewed files were insufficiently 

detailed to meet the standards set by the 

Florida Board of Medicine to justify the 

prescribing of controlled substances. Id. 

at 81–82. The histories and pain 

assessment evaluations, as documented 

in the charts, were also ‘‘not adequate on 

the initial or ongoing basis,’’ because the 

forms used and the manner in which 

they were completed did not 

sufficiently catalogue key aspects, such 

as 

[the] particular pain level, where the pain 

was located, what it felt like, when was it 

worse, what made it better, what it made it 

worse, what have you done to alleviate or 

past treatments, and what can you not do 

with the pain? Observations on physical 

examination about how the person walks, 

gait and station. Consistency of neurologic 

and inadequacy of pathologic reflexes 

particularly, presence or absence, and 

adequate sensory examination. 

Musculoskeletal examination. And height 

and weight many times were not present. 

Id. at 80–81, see also id. at 128–32. 

Similarly, Dr. Kennedy opined that 

Respondent’s treatment plans, as they 

were reflected in the reviewed records, 

were ‘‘grossly inadequate’’ in that the use 

of controlled substances was the single 

option considered and employed, ‘‘[s]o 

everybody got essentially the same 

treatment regardless of their complaint, 

severity, physical examination [and] 

history.’’ Id. at 82–83. In Kennedy’s 

view, combining controlled substance 

medications that were utilized in the 

charts was not ‘‘bad by itself, but it was 

done across the board with everybody. 

* * * [with] essentially the same drugs 

at the same doses for all the individuals’’ 

Id. at 98. In Dr. Kennedy’s view, there 

were a panoply of other treatment 

options that could and should have 

been documented and discussed with 

the Respondent’s pain patients. Id. 162– 

64. 

Dr. Kennedy also made the ironic 

observation that although to the 

‘‘extremely rare’’ 31 extent controlled 

substance medication adjustments were 

ever effected by the Respondent, they 

went up, and the forms utilized by the 

Respondent (and the practice in general) 

only provided a checkbox for reduction, 

or weaning. Id. at 95–96. This is 

essentially inconsistent with the normal 

practice of starting controlled substance 

treatment at the lowest dose possible to 

attain the desired result and adjusting 

upwards. Id. The form used by the 

Respondent seems to presume that the 

controlled substance doses would 

generally progress downward. Dr. 

Kennedy testified that he saw no 

evidence of medication adjustment to 

accommodate treatment, or ‘‘titration,’’ 

in any of the charts he examined. Id. at 

174. 

Although Dr. Kennedy conceded that 

it is the judgment of the examining 

physician that is generally relied upon 

in determining the necessity and 

appropriateness of diagnostic testing,32

he also testified that the Respondent’s 

practice of routinely ordering magnetic 

resonance imaging (MRI) procedures 

before he met with the patients was 

inappropriate because an MRI is not 

always required and not always 

appropriate. Id. at 71–73, 153–54. In 

Kennedy’s opinion, a physician has an 

obligation to meet with the patient 

before including this procedure as part 

of the utilized diagnostic tools. Id. 

Dr. Kennedy opined that the 

Respondent’s prescribing of opioids 

lacked a legitimate medical purpose in 

that he routinely prescribed oxycodone 

in initial 30 milligram (mg) doses that 

significantly exceeded the 

recommended 0.5 to 2.5 mg starting 

dosage.33 Id. at 86–87. Kennedy 

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34At 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. 

35 Govt. Ex. 5 at 4. 

36 Govt. Ex. 5 at 4. In Dr. Kennedy’s opinion, the 

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

initial doses of controlled substance combinations 

despite being outside the bounds of professional 

practice for histories and physical examinations 

and absent past medical records.’’ Id. at 7. 

37 Govt. Ex. 5 at 4. 

38 Govt. Ex. 5 at 3. 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. 

39 Govt. Ex. 5 at 7. In Dr. Kennedy’s opinion, 

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

to receive appropriate medical evaluation and 

treatment. In other words, the very potent, high 

doses of opioids (oxycodone) and benzodiazepine 

(Xanax) could mask or cover up [GA’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 10. 

40 Govt. Ex. 5 at 7. 

explained that a patient who has never 

had opioids, or has been off them for 

two to four weeks is classified as 

‘‘opioid naı ̈ve’’ and would feel the affects 

of the medication with smaller doses 

that can be increased as needed. Id. at 

83–86. The dosage levels prescribed by 

the Respondent, in Dr. Kennedy’s view, 

would always require significant 

monitoring of the medication’s effect on 

the patient, generally done in an office 

or hospital, and not an outpatient 

setting. Id. at 86–88. 

In this regard, Dr. Kennedy 

highlighted the chart of patient JR.34

Govt. Ex. 7. JR’s patient chart reflects his 

disclosures that he had not been 

prescribed pain medication within the 

twenty-eight days preceding his first 

appointment with the Respondent. Id. at 

20. A notation on JR’s pain contract 

indicates that he was not currently 

taking any medications at the time of his 

appointment. Id. at 23. Notwithstanding 

the fact that JR, at least by his 

representations, presented as an opioid 

naı ̈ve patient, the Respondent issued 

prescription scripts for 30 mg of 

Roxicodone and 2 mg of Xanax. Id. at 

17. Kennedy characterized prescribing 

these controlled substances as 

‘‘absolutely dangerous if [the patient] 

took that as prescribed. There would be 

a significant incident of respiratory 

depression, drug overdose and 

potentially death.’’ Tr. at 90. When 

pressed on the relative likelihood of 

adverse effects, Dr. Kennedy responded 

this way: 

If the records that the patient filled out 

themselves [sic] are correct, then that 

especially given with the Xanax, which is a 

benzodiazepine like Valium[,] [i]ts generic 

name is alprazolam[,] [a]nd that’s a high dose 

of Xanax as well. [] [T]he typical starting 

dose of Xanax is .25 to 0.5 [mg]. So, that’s 

four to eight times higher than the usual dose 

on that, and that’s given twice daily. Given 

that they work different areas in the nervous 

system and they both can cause sedation and 

potentially respiratory depression, there’s at 

least an additive if not a synergistic effect 

between when you mix different components 

of an opioid like oxycodone, a narcotic pain 

reliever, with a benzodiazepine like Xanax, 

alprazolam, especially at those doses in a 

naı ̈ve person for both drugs, that makes it 

even more dangerous. 

Id. at 91. Dr. Kennedy was asked to 

clarify whether this was an area where 

reasonable medical professionals could 

differ and provided this emphatic 

clarification: 

No sir, this isn’t even close. There’s no 

room, wiggle room on this. This is absolutely 

beyond the pale. 

Id. at 92. 

Notwithstanding his expressed 

concerns over the potency of some of 

the controlled substances prescribed by 

the Respondent, Dr. Kennedy was struck 

by the fact the charts of several of the 

Respondent’s patients reflected no 

indication that any acceptable measure 

of mental status, cognitive ability and 

response time was undertaken. Id. at 

102–07. 

On cross-examination, Dr. Kennedy 

agreed that the reviewed charts reflected 

objective signs that arguably supported 

medically determinable impairments 

that could cause chronic pain 

conditions, and that the controlled 

substance medications that were 

prescribed by the Respondent were 

among those that could be correctly 

employed to treat chronic pain. Id. at 

132–33, 135–37, 140–42, 144–45, 148– 

51. However, Dr. Kennedy remained 

steadfast in his dual views that the 

Respondent’s medical records simply 

did not contain enough information for 

a physician to reach the conclusion that 

the prescribing was appropriate and that 

the medication doses were simply too 

high. Id. at 123, 126–27, 166. Kennedy 

was also consistent in his position that 

MRI results, standing alone, are not a 

reliable indicator of an impairment 

indicating the utilization of controlled 

substance medications. Id. at 55–63, 

130–31, 164–66. 

In his Patient Charts Analysis, Dr. 

Kennedy focuses on a patient chart 

related to GA, one of the Respondent’s 

patients, and opines that the flaws 

identified in GA’s chart are common to 

all fifteen of the Respondent’s files that 

he reviewed. Specifically, the Patient 

Charts Analysis states that the charts he 

reviewed ‘‘are essentially the same with 

regard to review issues; as stated in the 

report of [GA] referenced and discussed 

in this report in detail, [and that] there 

were no significant differences that 

affected [his] conclusions and 

summary.’’ Govt. Ex. 5 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 bounds 

of professional practice due to their 

brevity and quality’’; 35 (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; 36 (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’’; 37 (4) contained medication 

contracts that were ‘‘not always signed’’ 

and ‘‘listed criteria that was not 

followed by the doctors at American 

Pain; 38 (5) failed to adequately 

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’ ’’; 39 (7) reflected ‘‘no 

therapeutic plan, except to use 

controlled substances to ‘treat’ the 

subjective complaint of ‘pain’ which 

was inadequately described; 40 (8) 

reflected ‘‘inadequate therapeutic goals 

* * * for improvement of quality of life 

(activities of daily living, work, sleep, 

mood) with the prescription of 

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41 Govt. Ex. 5 at 7. 

42 Govt. Ex. 5 at 7. 

43 Govt. Ex. 5 at 15. The only past medical record 

contained in GA’s chart was a report from an MRI 

conducted one day prior to the patient’s initial 

office visit at American Pain. Id. at 8. 

44 Govt. Ex. 5 at 14. 

45 Govt. Ex. 5 at 15. 

46 Govt. Ex. 5 at 13. 

47 Govt. Ex. 5 at 7, 15. 

48 Govt. Ex. 5 at 15; Tr. at 67–68. 

49Although the Government elicited testimony 

from Dr. Kennedy concerning his perceived 

significance to a ‘‘majority’’ of patients coming from 

out of State, Tr. at 116–17, since there was no 

evidence regarding what percentage of the 

Respondent’s patients were from outside Florida, 

this inquiry and its responses have been given no 

weight. 

50 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. 

51 Dr. Kennedy testified that although Florida 

does not have a PMP, several of the States where 

some of the Respondent’s patients resided did have 

such programs, and that the Respondent would 

have had access to obtain information about his 

patients in this manner. Tr. at 113. 

52The 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. 

controlled substance ‘cocktails’’’; 41 (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/or psychology’’; 42 (10) 

reflected ‘‘a gross lack of past medical 

records in all charts reviewed and in 

some cases none at all’’; 43 and, (11) 

demonstrated controlled substance 

patient monitoring practices that were 

‘‘not within the standard of care and 

outside the boundaries of professional 

practice.’’ 44

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. 5 at 14. 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, and expressed 

concern that the in-house urinalysis 

documentation that was maintained did 

not provide sufficient detail regarding 

the procuring and maintaining of the 

sample to meaningfully gauge its 

reliability. Id.; Tr. at 107–111. Kennedy 

expressed his view that the whole drug 

testing process at the Respondent’s 

office was inadequate. Furthermore, the 

charts contained only rare evidence of 

contact with primary care physicians, 

treating physicians, pharmacists, or 

other health care providers. Id. 

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,45 incomplete history 

information provided by the patients, 

periodically significant gaps between 

office visits,46 referrals from friends, 

relatives, or advertising, but not other 

physicians,47 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.48 During his 

testimony, Dr. Kennedy conceded that, 

standing alone, the Respondent’s 

treating out-of-State patients has no 

particular significance, and that when 

he was engaged in the practice of 

medicine in Kentucky he had patients 

who traveled to his office from 

Florida.49 Tr. at 116. Regarding the 

Respondent’s Kentucky patients, Dr. 

Kennedy observed that there were 

numerous medical and osteopathic 

schools that were much closer to the 

homes of these patients that could have 

provided pain management. Id. at 116– 

17. 

Although Dr. Kennedy’s report and 

testimony appear to attach some 

significance to referrals that originated 

in family and friends, he later clarified 

that it was not unusual for a physician 

to treat patients that have been referred 

by relatives and friends. Id. 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.’’ Id. at 154–55. 

Given Dr. Kennedy’s acknowledgement 

that such referrals are not unusual, 

coupled with the absence of any way to 

measure the relative percentage of 

physician referrals in the Respondent’s 

practice based on the record evidence, 

the observations regarding referral 

sources are of limited value here.50

During his testimony as well as his 

report, Dr. Kennedy highlighted several 

features of particular charts that, at least 

in his view, bore the indicia of some red 

flags that should have signaled an 

increased risk of controlled substance 

diversion. Kennedy detailed several 

controls that should have been, but were 

apparently not utilized by the 

Respondent to monitor diversion risks 

in a pain management practice. Id. at 

111. Some examples of expected 

diversion controls that were available 

to, yet absent from the Respondent’s 

practice included random pill counts, 

communication with family members, 

blood tests to supplement urinalysis 

drug screens, communication with 

patient pharmacists and the acquisition 

of pharmacy readout sheets to evaluate 

the prescriptions filled and sources of 

those prescriptions, and the acquisition 

of printouts from prescription 

monitoring programs (PMPs) in some of 

the States 51 where his patients resided. 

Id. at 111–13. 

Although not touched upon by Dr. 

Kennedy in his testimony or report,52

there were other indications of potential 

red flags and related anomalies among 

the charts admitted into evidence. For 

example, patient JR’s chart contains a 

form indicating a positive UDS for 

oxycodone and opiates from 12/30/09, 

yet on the same date, the medication 

contract signed by JR reflects a 

handwritten ‘‘N/A’’ notation in the 

section where a patient is supposed to 

list any medications they are currently 

taking. Govt. Ex. 7 at 10, 23; see also 

Govt. Ex. 19 at 10–11, 23 (similar issue). 

Patient MR’s file, on the other hand, 

indicates a positive UDS for oxycodone 

only, yet the patient indicates he is 

currently taking Xanax (a 

benzodiazepine that should have 

triggered a positive UDS reading) on two 

different documents, a discrepancy 

which raises questions about the 

validity of the testing procedures and/or 

the patient’s candor. Govt. Ex. 8 at 13– 

14, 28; see also Govt. Exs. 10 at 9, 22; 

12 at 12, 26; 17 at 12–13 (similar 

discrepancies present in other patient 

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53Tr. at 628. 

54The Respondent did not testify on his own 

behalf. 

55This authority has been delegated pursuant to 

28 CFR 0.100(b) and 0.104. 

files with respect to those drugs present 

on UDS in comparison to current 

medications listed in medication 

contract and other forms). Patient BS’s 

UDS indicates a negative test for all 

listed substances, yet on two different 

forms she indicates she is currently 

taking two strengths of Roxycodone 

along with Xanax. Govt. Ex. 16 at 6–7, 

18. 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. The UDS form in patient 

TS’s file reflects circled positive results 

for benzodiazepines, opiates, and 

oxycodone on ‘‘2/12,’’ yet the words 

‘‘Neg Test’’ is handwritten and circled in 

the margin. Govt. Ex. 13 at 9. Numerous 

patient files also reflected notations that 

patients ‘‘requested’’ specific types and/ 

or strengths of controlled substances. 

Govt. Exs. 6 at 6; 7 at 2; 8 at 4; 17 at 

2; 20 at 3; 21 at 3. 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. 

Interestingly, in his report, 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. 5 at 

3, 16. The report reflected Kennedy’s 

view 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 16. 

Significantly, however, when asked, Dr. 

Kennedy acknowledged that he 

conducts his own current medical 

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

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. 5 at 16. 

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,53 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. 

Tr. 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.54 Dr. Kennedy testified that 

based on his review of the selected 

patient charts from the Respondent’s 

medical practice, in his expert opinion, 

he ‘‘couldn’t find any legitimate basis for 

[the Respondent] prescribing 

medications to any of the [patients] and 

that the Respondent’s prescribing 

practices ‘‘were not in compliance at all 

from the very first visit on’’ with the 

standards set forth by the Florida 

Medical Board. Id. at 118. 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 55 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 (DC Cir. 2005). The 

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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 

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 (DC 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 (DC Cir. 2008) (citing Butz v. 

Glover Livestock Comm. Co., Inc., 411 

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

U.S. __, 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 (DC 

Cir. 2008), cert. denied, __ U.S. __, 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 

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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, 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 both 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 

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 ‘‘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. 

The Government’s Prehearing 

Statement also represented that it would 

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56The statutory definition of the term ‘‘dispense’’ 

includes the prescribing and administering of 

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

57ALJ Ex. 6 at 11–12. 

58Respt’s Br. at 20. 

59The Respondent’s brief incorrectly sites 

subsection (f). 

60Tr. at 825. 

61Tr. at 826. 

62Tr. at 898. 

be presenting the testimony of 

Intelligence Analyst (IA) Janet Hines, 

who would relate her encounter with a 

confidential source who allegedly 

obtained controlled substances from the 

Respondent with minimal or no 

physical examinations and intentionally 

diverted them. ALJ Ex. 6. The 

Government never called IA Hines and 

never offered an explanation for the 

differences between the expansive 

proffers and the less-expansive ultimate 

presentation. 

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 University of Tennessee 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 56

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. 

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. Without some insight into what 

types of results from these databases 

should be expected when compared to 

similarly-situated 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 16th 

largest practitioner purchaser of 

oxycodone in the United States.’’ 57 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, as ably pointed 

out by Respondent’s counsel,58 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).59 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 controlledsubstance-inventory-related 

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. 

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, 

were 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 work 

at American Pain at the same time the 

Respondent did, and did not 

specifically name any physician as 

being connected with his allegations of 

misconduct. 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 

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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). 

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). 

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 

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 

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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). 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. 

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 

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; 

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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 

physician’s prescribing practices are 

‘‘within the usual course of professional 

practice.’’ Here, the uncontroverted 

expert opinion of Dr. Kennedy, the only 

expert witness to testify at 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 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 Argument, Proposed Findings 

of Fact and Proposed Conclusions of 

Law (Respondent’s Brief), the 

Respondent’s counsel has prepared and 

submitted a thoughtful and detailed 

analysis of the counsel’s application of 

the relevant standards in Florida to the 

charts analyzed by Dr. Kennedy. Respt’s 

Br. at 3–17. Unfortunately, counsel’s 

analysis 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, 

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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. 

mstockstill on DSKH9S0YB1PROD with NOTICES