Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices 19401 

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 had been 

reformatted. 

the Government, through its expert, has 

alleged that the Respondent’s charts do 

not reflect genuine analysis, but rather 

(at least in its view and the opinion of 

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

form designed specifically to present a 

false impression of a compliant 

registrant, it is precisely the type of 

allegation that would naturally all but 

oblige a registrant to spring to offer a 

contradictory account. The 

Respondent’s choice to remain silent in 

the face of such allegations, where he 

could have related his version of his 

practice as a registrant, adds at least 

some additional credence to the factual 

and analytical views of the 

Government’s expert in this regard. 

In the Social Security context, where 

an Administrative Law Judge has 

received expert medical opinions on the 

issue of the claimant’s ability to work 

and they are not repudiated in any 

respect by substantial evidence, an 

adverse decision should be set aside as 

based on ‘‘suspicion and speculation.’’ 

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

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

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

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

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

to reject uncontroverted evidence 

supporting complaints of pain simply 

because of claimant’s demeanor at 

hearing). When an administrative 

tribunal elects to disregard the 

uncontradicted opinion of an expert, it 

runs the risk of improperly declaring 

itself as an interpreter of medical 

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

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

it is ironically true, much like in the 

Social Security context, that the opinion 

of a treating physician should be 

afforded greater weight than the opinion 

of an expert whose opinion is limited to 

a review of the patient file, see 

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

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

Respondent in this case offered no 

evidence, not even his own opinion, 

regarding the treatment rendered. Thus, 

in this adjudication, the record contains 

no dispute between experts to be 

resolved; instead, there is but one, 

unrefuted, uncontroverted, credible 

expert opinion. To ignore that expert 

opinion on this record and replace it 

with the opinion of this tribunal, 

Respondent’s counsel, or any other lay 

source would be a dangerous course and 

more importantly, a plainly erroneous 

one. 

Accordingly, after carefully balancing 

the admitted evidence, the evidence 

establishes, by a preponderance, that the 

prescriptions the Respondent issued in 

Florida were not issued within ‘‘the 

usual course of [the Respondent’s] 

professional practice.’’ 21 CFR 

1306.04(a). Consideration of the 

evidence under the second and fourth 

factors support the COR revocation 

sought by the Government in this case. 

To the extent that the Respondent’s 

prescribing practices fell below the 

requisite standard in Florida, that 

conduct also impacts upon the Fifth 

statutory factor. Under Factor 5, the 

Deputy Administrator is authorized to 

consider ‘‘other conduct which may 

threaten the public health and safety.’’ 

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

authorizes consideration of a somewhat 

broader range of conduct reaching 

beyond those activities typically 

associated with a registrant’s practice, 

an adverse finding under this factor 

requires some showing that the relevant 

conduct actually constituted a threat to 

public safety. See Holloway Distrib., 72 

FR 42118, 42126 (2007). 

The evidence establishes that the 

Respondent engaged in a course of 

practice wherein he prescribed 

controlled substances to patients 

irrespective of the patients’ need for 

such medication and ignoring any and 

all red flags that could or did indicate 

likely paths of diversion. The testimony 

of Dr. Kennedy, the DEA regulations, 

and the Florida Standards make clear 

that physicians prescribing controlled 

substances do so under an obligation to 

monitor the process to minimize the risk 

of diversion. The patient charts reflect 

that the Respondent, contrary to his 

obligations as a DEA registrant, did not 

follow up in the face of multiple red 

flags. The Respondent’s disregard of his 

obligations as a DEA registrant and 

Federal and state laws related to 

controlled substances militate in favor 

of revocation. 

By ignoring his responsibilities to 

monitor the controlled substance 

prescriptions he was authorizing to 

minimize diversion, and by 

participating in an insufficiently 

documented and thoughtful process for 

the issuance of potentially dangerous 

controlled substances, the Respondent 

created a significant potential conduit 

for the unchecked diversion of 

controlled substances. See Holloway 

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

no evil, hear no evil’’ is fundamentally 

inconsistent with the obligations of a 

DEA registrant). Agency precedent has 

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

absolutely no difference between the 

sale of an illicit drug on the street and 

the illicit dispensing of a licit drug by 

means of a physician’s prescription.’’ 

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

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

(1988). 

Agency precedent has consistently 

held that where, as here, the 

Government has met its burden to 

establish a prima facie case that a 

registrant has committed acts 

demonstrating that continued 

registration is inconsistent with the 

public interest, acceptance of 

responsibility is a condition precedent 

to continued registration. Jeri Hassman, 

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

Shoppe, 73 FR at 387. The record 

contains no evidence that the 

Respondent has either acknowledged or 

accepted responsibility for the 

misconduct at issue in these 

proceedings. 

Recommendation 

Based on the foregoing, the evidence 

supports a finding that the Government 

has established that the Respondent has 

committed acts that are inconsistent 

with the public interest. A balancing of 

the statutory public interest factors 

supports the revocation of the 

Respondent’s Certificate of Registration 

and a denial of his application to renew. 

The Respondent has not accepted 

responsibility for his actions, expressed 

remorse for his conduct at any level, or 

presented evidence that could 

reasonably support a finding that the 

Deputy Administrator should continue 

to entrust him with a Certificate of 

Registration. 

Accordingly, the Respondent’s 

Certificate of Registration should be 

revoked and any pending applications 

for renewal should be denied. 

Dated: August 10, 2010. 

John J. Mulrooney, II, 

U.S. Administrative Law Judge. 

[FR Doc. 2011–8340 Filed 4–6–11; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 10–35] 

Beau Boshers, 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 record in its 

entirety including Respondent’s 

exceptions, I have decided to adopt, 

except as explained below, the ALJ’s 

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2As I also explained in Krishna-Iyer, while 

Congress directed the Agency to consider all of the 

section 823(f) factors, I am entitled to give each 

factor the weight I deem appropriate and the courts 

of appeals have recognized that findings under a 

single factor are sufficient to support the revocation 

of a registration. 74 FR at 462 (citing Hoxie v. DEA, 

419 F.3d 477, 482 (6th Cir. 2005); Morall v. DEA, 

412 F.3d 165, 173–174 (DC Cir. 2005). As I further 

explained, ‘‘this 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; what matters is the seriousness 

of the registrant’s misconduct.’’ Id. at 462. 

3 In Krishna-Iyer, I noted that the practitioner had 

discharged several patients. 74 FR at 462. However, 

I held that this evidence was not probative of the 

practitioner’s intent in prescribing to the other 

patients who were focus of the proceeding. Id. & 

n.6. 

4 I do not adopt the ALJ’s discussion of the 

standards applied by the Agency in assessing a 

practitioner’s experience in dispensing controlled 

substances, which cites primarily to cases involving 

list chemical I distributors, a different category of 

registrant. See ALJ Dec. at 25–26. As one example 

as to why, DEA routinely issues registrations to 

newly-licensed practitioners even though they 

cannot point to any experience in dispensing 

controlled substances (provided they have not 

previously violated controlled substance laws.). 

Conversely, DEA has never held that a practitioner’s 

lengthy experience in dispensing controlled 

substances without diverting precludes a finding 

(where supported by substantial evidence showing 

that he did divert) that a practitioner has committed 

acts which render his registration ‘‘inconsistent 

with the public interest.’’ 21 U.S.C. 824(a)(4). 

In any event, as discussed above, Respondent 

offered no evidence on the issue of his experience 

in dispensing controlled substances and the ALJ’s 

ultimate conclusion that Respondent violated the 

CSA’s prescription requirement because he 

dispensed controlled substance prescriptions that 

were not ‘‘within’’ ‘usual course of [his] professional 

practice,’’ ALJ at 41 (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 actuallys constituted a 

threat to public safety.’’ ALJ at 41 (emphasis added 

and citation omitted.) 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 

rulings, findings of fact, conclusions of 

law, and recommended Order. 

Respondent raises two exceptions to 

the ALJ’s recommended decision. First, 

he argues that ‘‘he was denied the ability 

to present his positive experience in 

dispensing controlled substances.’’ Resp. 

Exc. at 1. More specifically, he argues 

that he was denied ‘‘access to files 

seized’’ by the Government which show 

that he discharged patients, and that 

‘‘[w]ithout access to those files,’’ he was 

left ‘‘with his hands tied behind his back 

and [was] unable to demonstrate his 

successful treatment of patients with 

controlled substances.’’ Id. at 1–2. 

Respondent contends that this 

‘‘effectively crippl[ed] his ability to 

present any evidence of his positive, or 

successful, experience in dispensing 

and treating patients with controlled 

substances.’’ Id. at 1. 

As support for his contention that he 

is entitled to present evidence of his 

‘‘positive experience,’’ Respondent cites 

the Agency’s decision on remand in 

Jayam Krishna-Iyer, 74 FR 459 (2009). 

That decision addressed an unpublished 

decision of the United States Court of 

Appeals for the Eleventh Circuit, which 

vacated the Agency’s Order revoking a 

practitioner’s registration on the ground 

that it failed to consider the 

practitioner’s ‘‘experience with twelve 

patients whose medical charts were 

seized by the DEA, or with thousands of 

other patients. In short, the DEA did not 

consider any of the Petitioner’s positive 

experience in dispensing controlled 

substances.’’ Id. (quoting Krishna-Iyer v. 

DEA, 249 Fed. Appx. 159, 160 (11th Cir. 

2007)). 

While this Agency complied with the 

Eleventh Circuit’s order, unpublished 

decisions are ‘‘not precedential.’’ United 

States v. Shaw, 560 F.3d 1230, 1241 

(11th Cir. 2009). Moreover, as I noted in 

Krishna-Iyer, ‘‘[t]he Court of Appeals did 

not cite to any decision of either this 

Agency or another court defining the 

term ‘positive experience.’ Nor did the 

Court offer any guidance as to the 

meaning of this term, which is not to be 

found in the’’ Controlled Substances 

Act. 74 FR at 460. 

I thus assumed—even though there 

was no evidence (except for twelve 

patient files) in the record regarding the 

legitimacy of the practitioner’s 

prescribing of controlled substances to 

the ‘‘thousands of other patients’’ she 

had treated—that her prescribings to 

these patients constituted ‘‘positive 

experience.’’ Id. at 460–61. However, the 

practitioner’s ‘‘prescribings to thousands 

of other patients [did] not * * * render 

her prescribings to the undercover 

officers any less unlawful, or any less 

acts which ‘are inconsistent with the 

public interest.’’’ Id. at 463 (quoting 21 

U.S.C. 823(f)).2

As Krishna-Iyer explained, because 

the CSA limits registration as a 

practitioner ‘‘to those who have 

authority to dispense controlled 

substances in the course of professional 

practice, and patients with legitimate 

medical conditions routinely seek 

treatment from licensed medical 

professionals, every registrant can 

undoubtedly point to an extensive body 

of legitimate prescribing over the course 

of her professional career.’’ Id.; see also 

21 U.S.C. 823(f) (registration limited to 

a practitioner ‘‘authorized to dispense 

* * * controlled substances under the 

laws of the State in which he 

practices’’). I further noted that ‘‘in past 

cases, [DEA] has given no more than 

nominal weight to a practitioner’s 

evidence that he has dispensed 

controlled substances to thousands of 

patients in circumstances which did not 

involve diversion.’’ Id. (quoting Paul J. 

Caragine, Jr., 63 FR 51592, 51599 (1998) 

(‘‘[T]he Government does not dispute 

that during Respondent’s 20 years in 

practice he has seen over 15,000 

patients. At issue in this proceeding is 

Respondent’s controlled substance 

prescribing to 18 patients.’’); id. at 51600 

(‘‘[E]ven though the patients at issue are 

only a small portion of Respondent’s 

patient population, his prescribing of 

controlled substances to these 

individuals raises serious concerns 

regarding [his] ability to responsibly 

handle controlled substances in the 

future.’’); Medicine ShoppeJonesborough, 73 FR 364, 386 & n.56 

(2008) (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)). 

DEA has thus revoked a practitioner’s 

registration based on a single act of 

presenting two fraudulent prescriptions 

to a pharmacy for filling; see Alan H. 

Olefsky, 57 FR 928, 928–29 (1992), and 

DEA can revoke based on a single act of 

diversion. Dewey C. MacKay, 75 FR 

49956, 49977 (2010). See also Sokoloff 

v. Saxbe, 501 F.2d 571, 576 (2d Cir. 

1974) (upholding revocation of 

practitioner’s registration based on nolo 

contendre plea to three counts of 

unlawful distribution). Undoubtedly, 

each of these practitioners could have 

pointed to evidence of having treated a 

large number of patients in 

circumstances in which he did not 

divert controlled substances to drug 

abusers or drug dealers. 

Consistent with these precedents, I 

held in Krishna-Iyer that ‘‘evidence that 

a practitioner has treated thousands of 

patients in circumstances which do not 

constitute diversion,’’ and has even 

refused to prescribe to certain patients,3

‘‘does not negate a prima facie showing 

that the practitioner has committed acts 

inconsistent with the public 

interest.’’ 4 74 FR at 463. I further held 

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Respondent repeatedly ignored ‘‘red flags’’ 

indicative of likely diversion and thus ‘‘created a 

significant potential conduit for the unchecked 

diversion of controlled substances’’ is clearly 

support by substantial evidence and warrants an 

adverse finding under factor five. ALJ at 42. 

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 37 (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 

is necessarily dependent 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. 

5Nor is it clear what Respondent means by 

‘‘positive experience.’’ Resp. Exc. at 1. While at 

various points Respondent refers to files which he 

asserts show that he discharged patients, he then 

maintains that his lack of access to the files prevent 

him from presenting ‘‘any evidence of his positive, 

or successful, experience in dispensing and treating 

patients with controlled substances.’’ Id. (emphasis 

added). He likewise contends that he was ‘‘unable 

to demonstrate his successful treatment of patients 

with controlled substances.’’ Id. at 2 (emphasis 

added). However, it is not DEA’s role to assess 

whether a practitioner has successfully treated 

patients, but rather, to determine whether a 

practitioner is either diverting drugs or engaging in 

practices (whether intentional or not) that create a 

substantial risk of diversion. See Caragine, 63 FR 

at 51601 (‘‘Careless or negligent handling of 

controlled substances creates the opportunity for 

diversion and [can] justify revocation [or a 

registration] or denial’’ of an application). 

6 Indeed, it appears that the patient files (which 

the expert reviewed) were provided to Respondent 

nearly two months before the hearing. 

7The Government also attempted to introduce 

evidence that Respondent prescribed to a member 

of a Boston-based drug trafficking organization, who 

had been arrested with 3,000 oxycodone tablets in 

his possession, and who stated that he did not have 

a legitimate medical need for the drugs he obtained 

from Respondent. Tr. 829–32. For the reasons stated 

in his decision, the ALJ properly gave this 

testimony no weight. See ALJ Dec. at 10 n.23. 

that while such evidence may be 

entitled to some weight in assessing 

‘‘whether a practitioner has credibly 

shown that she has reformed her 

practices, where a practitioner commits 

intentional acts of diversion and insists 

she did nothing wrong, such evidence is 

entitled to no weight.’’ Id. 

Respondent’s exception is neither 

factually nor legally well taken. 

Contrary to his assertion that his hands 

were ‘‘tie[d] behind his back’’ and that 

he was ‘‘effectively cripple[ed]’’ from 

‘‘present[ing] any evidence of’’ what he 

terms ‘‘his positive * * * experience,’’ 5

Respondent could have testified about 

his dispensing practices and addressed 

those instances in which he refused to 

prescribe controlled substances; his 

decision to not put on evidence on this 

issue was not a matter ‘‘of 

impossibility,’’ but of ‘‘choice.’’ Resp. 

Exc. at 1. 

Most significantly, Respondent could 

have testified regarding his prescribing 

practices with respect to the patients 

whose files were reviewed by the 

Government’s Expert and which formed 

the basis for the latter’s (and the ALJ’s) 

conclusion that Respondent acted 

outside of the usual course of 

professional practice and lacked a 

legitimate medical purpose in 

prescribing controlled substances to 

them. See ALJ Dec. at 41 (citing 21 CFR 

1306.04(a)). Alternatively, he could 

have retained his own expert to review 

the files and called the expert to testify. 

Notably, Respondent makes no claim 

that the files, which were reviewed by 

the Government’s Expert, were not 

timely provided to him.6

Respondent also takes exception to 

the ALJ’s finding that he was not 

prejudiced by the Government’s failure 

to turn over ‘‘the discharged patient 

files,’’ as well as evidence pertaining to 

a second undercover officer to whom he 

refused to prescribe. Resp. Exc. at 2. 

Respondent asserts that his right to Due 

Process was violated because this 

evidence ‘‘could have exonerated’’ him, 

‘‘or at the very least, given him an 

opportunity to meaningfully defend 

against the Government’s allegations,’’ 

and that prejudice ‘‘must [be] assume[d] 

* * * because neither he nor the Court 

were ever given access to it.’’ Id. 

As an initial matter, while there is 

evidence that Respondent refused to 

prescribe to a second undercover officer, 

there is no evidence establishing that 

there were, in fact, ‘‘discharged patient 

files.’’ Respondent neither testified, nor 

offered any other evidence such as an 

affidavit establishing, that such files 

exist. Most significantly, in his 

Exceptions, Respondent does not cite 

any authority for the proposition that 

the Agency is required to provide broad 

discovery in a proceeding under 

sections 303 and 304 of the CSA. See 

generally Resp. Exc. Indeed, 

Respondent’s contention far exceeds 

what the Supreme Court has held that 

an agency must do to comply with the 

Due Process Clause. See, e.g., Goldberg 

v. Kelly, 397 U.S. 254, 270 (1970). 

In Goldberg, the Supreme Court held 

that ‘‘ ‘where governmental action 

seriously injures an individual, and the 

reasonableness of the action depends on 

fact findings, the evidence used to prove 

the Government’s case must be 

disclosed to the individual so that he 

has an opportunity to show that it is 

untrue.’ ’’ 397 U.S. at 270 (quoting 

Greene v. McElroy, 360 U.S. 474, 496 

(1959) (emphasis added)). The Court has 

further explained that ‘‘[a] party is 

entitled * * * to know the issues on 

which [the] decision will turn and to be 

apprised of the factual material on 

which the agency relies for decision so 

that he may rebut it. Indeed, the Due 

Process Clause forbids an agency to use 

evidence in a way that forecloses an 

opportunity to offer a contrary 

presentation.’’ Bowman Transp., Inc., v. 

Arkansas-Best Freight System, Inc., 419 

U.S. 281, 288 n.4 (1974). 

It is well settled, however, that 

neither the Due Process Clause, nor the 

Administrative Procedure Act (nor 

DEA’s rules of procedure) require the 

Agency to provide a general right of 

discovery in administrative 

proceedings. See Echostar Comm. Corp. 

v. FCC, 292 F.3d 749, 756 (DC Cir. 

2002); Mister Discount Stockbrokers, 

Inc., v. SEC, 768 F.2d 875, 878 (7th Cir. 

1985); Nicholas A. Sychak, d/b/a/ 

Medicap Pharmacy, 65 FR 75959, 75961 

(2000). While ‘‘discovery must be 

granted if in the particular situation a 

refusal to do so would so prejudice a 

party as to deny him due process,’’ 

McClelland v. Andrus, 606 F.2d 1278, 

1285–86 (DC Cir. 1979), the party 

seeking discovery must rely on more 

than speculation and must show that 

the evidence is relevant, material, and 

that the denial of access to the 

documents is prejudicial. See Echostar, 

292 F.3d at 756; Silverman v. CFTC, 549 

F.2d 28, 34 (7th Cir. 1977). 

In this case, the ALJ based his 

conclusion that Respondent issued 

numerous prescriptions outside of the 

usual course of professional practice in 

violation of both Federal and State laws 

and thus had committed acts which 

render his registration inconsistent with 

the public interest, see ALJ Dec. at 39– 

42, on the Expert’s testimony and report 

regarding the various patients files the 

latter reviewed, each of which was 

provided to Respondent. Accordingly, 

the evidence which was the basis of the 

decision was disclosed to him, and 

contrary to his contention, see Resp. 

Exc. at 2, Respondent had a meaningful 

‘‘opportunity to show that it is 

untrue.’’ 7 Goldberg, 397 U.S. at 270. 

Respondent offers no explanation as to 

why other patient files would have 

‘‘exonerated’’ him from the allegations 

that his prescriptions to the patients, 

whose files were reviewed by the 

Expert, were issued outside of the usual 

course of professional practice and 

lacked a legitimate medical purpose. 

Nor does Respondent offer any legal 

authority for his contention that 

prejudice—which he cannot show— 

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8The ALJ explained that drawing an adverse 

inference was ‘‘appropriate under the circumstances 

of this case where the evidence of the unsuccessful 

US was clearly within the Government’s control 

and should, to maintain the integrity of the 

proceedings, have been disclosed if not produced.’’ 

ALJ at 32. It is unclear whether the ALJ believed 

that disclosure of this evidence was required as a 

matter of Due Process as the ALJ did not cite any 

authority for his reasoning and numerous courts (as 

well as this Agency) have held that Brady v. 

Maryland, 373 U.S. 83 (1963), does not apply to 

administrative proceedings. See Mister Discount 

Stockbrokers, 768 F.2d at 878; NLRB v. Nueva 

Engineering, Inc., 761 F.2d 961, 969 (4th Cir. 1985); 

Nicholas A. Sychak, 65 FR 75,959, 75960–61 (2000). 

Even if this evidence is of the type which a refusal 

to disclose ‘‘would so prejudice a party as to deny 

him due process,’’ McClelland v. Andrus, 606 F.2d 

at 1286, the evidence was disclosed through the 

testimony of the Special Agent. Respondent thus 

cannot show prejudice. 

9A registrant’s obligation to accept responsibility 

and demonstrate that he will not engage in future 

misconduct applies even where the Government’s 

evidence does not establish that a registrant has 

committed intentional acts. See Krishna-Iyer, 74 FR 

at 464 n.9; Caragine, 63 FR at 51601 (granting 

restricted registration where physician showed that 

he underwent remedial ‘‘training to become better 

educated in controlled substances and how to deal 

with drug-seeking patients’’). Thus, even if I had 

concluded that the evidence did not establish that 

Respondent knowingly diverted controlled 

substances, I would still revoke his registration 

because he failed to rebut the Government’s prima 

facie case. 

10Although the Respondent’s COR expired on 

July 31, 2010, the parties stipulated that a timely 

renewal application has been submitted by the 

Respondent. ALJ Ex. 40. 

11Pursuant 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. 

12A schedule II controlled substance. 

13The majority of which are supported by no 

evidence introduced by the Government during the 

course of these proceedings. 

must be assumed. See Mister Discount 

Stockbrokers, 768 F.2d at 878 (rejecting 

challenge to discovery procedures in 

administrative proceeding noting that 

party failed ‘‘to demonstrate any 

prejudice * * * let alone prejudice to a 

significant degree so as to result in a 

denial of due process’’). 

There is likewise no merit to 

Respondent’s contention that he was 

prejudiced by the Government’s failure 

to turn over the patient file of the 

undercover officer to whom he refused 

to prescribe. A Special Agent testified 

that Respondent had refused to 

prescribe to a second undercover officer 

and the Government failed to put 

forward any evidence regarding the 

circumstances of this visit (such as what 

the officer said to Respondent). For this 

reason alone, it was proper for the ALJ 

to draw an inference adverse to the 

Government and conclude that 

Respondent properly complied with the 

rules of the Florida Board of Medicine 

in evaluating the undercover officer. See 

ALJ at 32 (citing UAW v. NLRB, 459 

F.2d 1329, 1335–39 (D.C. Cir. 1972)).8

However, as the ALJ held, that 

Respondent refused to prescribe 

controlled substances in this single 

instance does not refute the 

Government’s prima facie showing that 

Respondent repeatedly violated the 

prescription requirement of Federal law 

as established by the Expert’s review of 

eighteen patient files. See id. at 41 

(quoting 21 CFR 1306.04(a)) (‘‘after 

carefully balancing the admitted 

evidence, [and] even applying an 

adverse inference that permits the 

assumption that the Respondent was 

approached by an undercover agent and 

acted appropriately, the evidence 

establishes, by a preponderance, that the 

prescriptions the Respondent issued 

* * * were not issued within ‘the usual 

course of [the Respondent’s] 

professional practice’ ’’). 

As noted above, Respondent did not 

testify. Nor did he offer the testimony of 

an expert. Thus, Respondent did not 

refute the opinion testimony of the 

Government’s Expert that he repeatedly 

violated the prescription requirement of 

Federal law. Because Respondent failed 

‘‘to testify in response to [the] probative 

evidence offered against’’ him, I 

conclude (as did the ALJ) that it is 

appropriate to draw an adverse 

inference against him and hold that he 

knowingly issued prescriptions in 

violation of 21 CFR 1306.04(a). Baxter v. 

Palmigiano, 425 U.S. 308, 316 (1976); 

see also The Lawsons, Inc., 72 FR 74334, 

74339 (2007). Because Respondent 

failed to testify, I also conclude that he 

has not accepted responsibility for his 

misconduct nor demonstrated that he 

will not engage in future misconduct, 

and therefore, he has not rebutted the 

Government’s prima facie showing that 

his continued registration is 

inconsistent with the public 

interest.9See Medicine ShoppeJonesborough, 73 FR at 387; Samuel S. 

Jackson, 72 FR 23848, 23853 (2007). I 

thus reject Respondent’s Exceptions and 

adopt the ALJ’s 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, 

FB0254918, issued to Beau Boshers, 

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

further order that any pending 

application of Beau Boshers, 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 

Jose M. Quinon, 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 FB02549187, 

of Beau Boshers, M.D. (Respondent), as a 

practitioner, pursuant to 21 U.S.C. 824(d), 

alleging that such registration constitutes an 

imminent danger to the public health and 

safety. The OSC/ISO also sought revocation 

of the Respondent’s registration, pursuant to 

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

pending applications for renewal 10 or 

modification of such registration, pursuant to 

21 U.S.C. 823(f), alleging that the 

Respondent’s continued registration is 

inconsistent with the public interest, as that 

term is used in 21 U.S.C. 823(f). On March 

22, 2010, the Respondent timely requested a 

hearing, which, pursuant to a change of 

venue granted at his request, was conducted 

in Miami, Florida, on July 7, 2010 through 

July 9, 2010.11 The immediate suspension of 

the Respondent’s COR has remained in effect 

throughout these proceedings. 

The issue ultimately to be adjudicated by 

the Deputy Administrator, with the 

assistance of this recommended decision, is 

whether the record as a whole establishes by 

substantial evidence that Respondent’s 

registration with the DEA should be revoked 

as inconsistent with the public interest as 

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

824(a)(4). 

After carefully considering the testimony 

elicited at the hearing, the admitted exhibits, 

the arguments of counsel, and the record as 

a whole, I have set forth my recommended 

findings of fact and conclusions below. 

The Evidence 

The OSC/ISO issued by the Government 

alleges that the Respondent, through the 

medical practice he participated in at 

American Pain, LLC (American Pain), 

prescribed and dispensed inordinate 

amounts of controlled substances, primarily 

oxycodone,12 under circumstances where he 

knew, or should have known, that the 

prescriptions were not dispensed for a 

legitimate medical purpose. ALJ Ex. 1. The 

OSC/ISO further charges that these 

prescriptions were issued outside the usual 

course of professional practice based on a 

variety of circumstances 13 surrounding the 

manner in which American Pain is operated 

and the manner in which its physicians, 

including the Respondent, engaged in the 

practice of medicine. Id. The Respondent is 

also alleged, on several occasions, to have 

provided undercover law enforcement 

personnel with controlled substances, 

including, inter alia, oxycodone and 

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14A schedule IC controlled substance. 

15Although GS Langston testified that DEA 

immediately suspended the COR that had been 

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

voluntary surrender by that registrant followed a 

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

presented that would lend that fact any particular 

significance related to any issue that must or should 

be found regarding the disposition of the present 

case. 

16 GS Langston testified that she was unaware of 

the location of the closest Walgreens to American 

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

presented that would tend to establish that any 

Walgreens or any other pharmacy has taken a 

position regarding its willingness to fill 

prescriptions authorized by American Pain. 

17Although GS Langston testified that she did not 

actually take the photographs 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. 

18 In his Discussion and Proposed Findings of 

Fact and Conclusions of Law (Respondent’s Brief), 

the Respondent argues that the selection criteria 

employed by Langston deprived him of due process 

and somehow created an inaccurate portrayal of his 

practice. Respt’s Br. at 4. However, the Respondent 

never explains the casual connection between the 

manner in which the files were selected, which was 

not based on any manner of targeting derogatory 

information regarding his patient care and why any 

due process right was compromised. 

19Langston 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. 

alprazolam,14 after cursory or no medical 

examinations, and therefore without a 

legitimate medical purpose. Id. The 

Government’s OSC/ISO also alleges that the 

Respondent’s former patients 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. Lastly, 

as an additional ground for the OSC/ISO, the 

Government cites the death of one of the 

Respondent’s patients from an overdose of 

controlled substances one day after obtaining 

prescriptions for some of those same 

controlled substances during a visit to the 

Respondent at American Pain, and that the 

investigation determined the deceased 

patient and two companions obtained those 

substances ‘‘for other than a legitimate 

medical purpose with the intention of selling 

the controlled substances in Kentucky.’’ 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.15 Id. at 721. Under Langston’s 

supervision, DEA diversion investigators 

catalogued the prescriptions seized at Boca 

Drugs (Boca Drugs Prescription Log). Govt. 

Ex. 118. 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, 166 controlled 

substance prescriptions issued over the 

Respondent’s signature, to seventy-five 

patients, only six of whom resided in Florida. 

The remainder of the patients had listed 

addresses in Kentucky, Tennessee, Ohio, 

Georgia, Indiana, Alabama and West Virginia. 

The data in the log further reflected that the 

Respondent issued three prescriptions for 

non-controlled substances during that time 

period. 

GS Langston also testified that, on March 

3, 2010, a criminal search warrant was 

executed on the American Pain Clinic 

simultaneously with the OSC/ISO that 

initiated the present case. Tr. at 735. 

According to Langston, the items seized from 

American Pain included a sign that had been 

posted in what she believes to have served 

as the urinalysis waiting room. Id. at 735–37. 

The seized sign set forth the following 

guidance: 

ATTENTION PATIENTS 

Due to increased fraudulent prescriptions, 

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

Florida or your regular pharmacy. Don’t go to 

a pharmacy in Ohio when you live in 

Kentucky and had the scripts written in 

Florida. The police will confiscate your 

scripts and hold them while they investigate. 

This will take up to 6 months. So only fill 

your meds in Florida or a pharmacy that you 

have been using for at least 3 months or 

more. 

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

apparently by some sort of tape, to the 

top portion of two other signs, posted 

at the same location, the first of which 

reads: 

ATTENTION 

Patients 

Please do NOT fill your prescriptions at 

any WALGREENS PHARMACY 16 or 

OUTSIDE the STATE OF FLORIDA. 

Id. The final attachment to the 

composite sign bears the words ‘‘24 

Hour Camera Surveillance.’’ 

Id. A photograph of the composite 

sign was admitted into evidence. 

Langston also testified that while she 

was present in the American Pain 

offices, she noticed that each 

physician’s desk was equipped with a 

group of stamps, each of which depicted 

a controlled substance medication with 

a corresponding medication usage 

instruction (sig). Tr. at 738–39. A 

photograph of one set of prescription 

script stamps was admitted as an 

exhibit.17 Govt. Ex. 119 at 2. 

GS Langston also testified that a great 

number of medical charts were seized 

from the American Pain offices, and that 

she and her staff selected a number of 

these files to be analyzed by an 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.18 Id. at 768. 

Langston also explained DEA’s 

Automated Record Consolidated 

Ordering System (ARCOS) 19 and 

testified that she generated an ARCOS 

report relative to the Respondent’s 

ordering of controlled substances from 

January 2009 through February 2010. 

Govt. Ex. 23. 

In the same fashion, Langston 

explained the purposes of and 

circumstances behind the generation of 

state prescription monitoring reports 

(PMPs) relative to the Respondent 

maintained by West Virginia, Kentucky 

and Ohio. Govt. Exs. 24–26. Review of 

the PMP report data reflects that during 

the time period of February 1, 2006 

through February 11, 2010, pharmacies 

filled 259 controlled substance 

prescriptions issued over the 

Respondent’s signature to sixty-eight 

patients located in West Virginia, 173 

similar prescriptions provided to 

seventy-nine Kentucky-based patients 

were filled between January 1, 2009 and 

April 4, 2010, and ninety such 

prescriptions pertaining to sixty-one 

patients located in Ohio were filled 

between April 1, 2008 and April 19, 

2010. Id. 

No evidence was introduced at the 

hearing that would provide any reliable 

level of context regarding the raw data 

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20SA Burt described the pole cameras as ‘‘covert 

cameras that are installed to observe the activity in 

the clinic.’’ Tr. 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 recirded to 

DVR. Id. at 821. 

21Tr. at 910. 

22SA 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. 

23Later on cross-examination, SA Burt admitted 

that the clinic also accepted payment via credit 

card. Tr. at 916. The parameters of what the witness 

meant by ‘‘predominantly’’ was not the subject of 

further explanation. 

24 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. 

25Burt further testified that the doctors were paid 

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

indicated that he could not disclose his basis of 

knowledge for this information, this portion of his 

testimony can be afforded no weight. See 

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

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

(11th Cir. 2000); Kelly v. Sullivan, 928 F.2d 227, 230 

(7th Cir. 1991); Calhoun v. Bailar, 626 F.2d 145, 149 

(9th Cir. 1980). 

26Tr. at 1002–05. 

27The 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. 

set forth in the databases received into 

evidence at the Government’s request. 

Other than the observations noted 

above, no witness who testified at the 

hearing ever explained the significance 

of the data set forth in any of these 

databases to any issue that must or 

should be considered in deciding the 

present case. 

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 20 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 21 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) 22 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’’ 23 for these office visits, and the 

six doctors at the clinic saw ‘‘anywhere 

from 200 upward to 375 patients a 

day’’ 24 in this manner.25 Id. at 882–83 

(emphasis supplied). 

SA Burt also testified regarding his 

review of some 26 of the video and audio 

recordings made by an undercover agent 

(UC) who assumed the name Luis Lopez 

capturing activity inside of American 

Pain.27 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 

Bart’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. 

Although noticed in SA Burt’s 

proposed testimony identified in the 

Government’s prehearing statement, 

testimony regarding the specifics of the 

UC’s visits to see the Respondent at 

American Pain was not elicited by the 

Government during its direct 

examination, but was brought out on 

cross-examination to meet the 

Government’s admitted evidence 

consisting of a patient file kept by the 

Respondent relative to the UC and the 

accompanying expert report and 

testimony concerning that file provided 

by Dr. Kennedy. Id. at 985–86; Govt. 

Exs. 46 (Patient File for Luis Lopez), 131 

(Supplemental Expert Report Regarding 

Undercover Patient Luis Lopez). Burt 

testified that he did not have the UC 

examined by a physician to determine 

his physical condition prior to going to 

the clinic, he did not ask him whether 

he had any prior back problems, and he 

did not ask him whether he had any 

past problems that caused a doctor to 

prescribe him controlled substances; 

instead, Burt relied solely on the UC’s 

representations he was not currently in 

any pain before sending him into the 

clinic. Tr. at 987–89. According to Burt, 

the only instructions he provided to the 

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28 In fact, as addressed infra, SA Burt did not 

review the recordings or read the history and 

physical examination form contained in the UC’s 

patient file with an eye towards determining if the 

audio corroborated the information on the forms. 

Furthermore, Burt admitted these recordings were 

not provided to Dr. Kennedy for his use in 

formulating his expert testimony and reports. Tr. at 

1007. 

29As discussed in more detail anon, this 

development was particularly troubling in light of 

the Respondent’s prehearing motion practice where 

he sought the disclosure of precisely this variety of 

evidence. 

30Tr. at 1012. 

31SA Burt testified that he has never actually 

seen the described pill bottle. Tr. at 830. Burt also 

revealed on cross-examination that he has never 

reviewed a patient file relative to CS1, and that said 

patient file was not reviewed by a doctor to 

determine the propriety of the controlled substance 

prescriptions purportedly issued by the 

Respondent. Id. at 1015. 

32 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 him, no weight can 

be assigned to SA Burt’s testimony concerning 

information provided by CS1, other than the fact 

that it may have informed 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). 

33Although 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. 

34According 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. 

35See Tr. at 836–53 (addressing exclusion of 

Govt. Ex. 27 and associated testimony). 

UC were to be ‘‘very vague regarding the 

pain,’’ to ‘‘point to a general area’’ when 

asked about it, and to provide a urine 

sample if so requested by clinic staff. Id. 

at 989–90, 1001. It was further 

established that an MRI was taken of the 

UC at Faye Imaging prior to his seeing 

the Respondent. Id. at 990–91. Burt 

related that the UC’s first visit to the 

clinic was approximately an hour and 

fifteen minutes, and his visit with the 

Respondent was ten to thirteen minutes 

long. Id. at 998–99. Although these 

encounters between the UC and the 

Respondent were recorded either via 

audio or video, the Government did not 

offer the recordings as evidentiary 

exhibits at the hearing, and opposing 

counsel did not have access to them.28

More troubling by far is the revelation 

during SA Burt’s cross examination that 

in addition to UC Luis Lopez, a second 

UC went into American Pain during July 

2009 and recorded his encounters with 

the Respondent. Those encounters by 

the second UC did not culminate with 

the Respondent prescribing controlled 

substances.29 Id. at 1027, 1029. 

SA Burt also testified that he received 

information from Dr. Eddie Sollie, a 

former physician employed during the 

time period American Pain was doing 

business as South Florida Pain, who 

terminated his employment at the 

Oakland Park clinic location in 

November or December 2008 after 

working there for approximately two 

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

898. During the course of an interview 

where Burt was present, Dr. Sollie 

related various ‘‘concerns about how the 

practice was being handled or 

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

included medical records being, in his 

opinion, annotated inadequately by the 

doctors, and what he perceived as a lack 

of supervision during patient urinalysis 

testing, where patients would ‘‘go[] to 

the bathrooms together, bringing items 

with them to the bathrooms that could 

possibly disguise the urinalysis.’’ 

According to Burt, Sollie explained that 

he perceived that patients were 

substituting urine produced by other 

persons that contained the metabolites 

for controlled substances that the 

patients claimed to be legitimately 

taking, with a view towards falsely 

providing evidence to the American 

Pain doctors showing that they were 

actually taking prescribed medications 

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

During cross-examination, Burt 

explained that Dr. Sollie told him he 

had raised these concerns with 

Christopher George, the owner of 

American Pain, and that Burt had no 

evidence that the deficient practices that 

Sollie had objected to continued 

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

acknowledged that he was aware Dr. 

Sollie had been involved in litigation 

with Mr. George and that their 

relationship was strained. Id. at 1009. 

Dr. Sollie was not called as a witness by 

either party. 

SA Burt also provided testimony 

concerning three confidential sources 

(only one of whom was seen by the 

Respondent) and their contacts with 

doctors at American Pain. Relative to 

the Respondent, the first confidential 

source (CS1) discussed by Burt was 

arrested in Washington, DC after 

transporting upwards of 3,000 

oxycodone pills from south Florida to 

Massachusetts, and at the time of his 

arrest, Burt testified that an empty 

prescription pill bottle from American 

Pain with the Respondent’s name on it 

was found on his person. Id. at 829. Burt 

relayed that at the time CS1 was 

searched, he had the 3,000 pills secreted 

in a jock strap strapped to the inside of 

his leg, and they were not in any type 

of bottle with the Respondent’s name on 

it. The individual told Burt during a 

July 2009 interview 30 that he was a 

member of a Boston-based drug 

trafficking organization that would 

obtain oxycodone in southern Florida 

and transport it back to Boston for 

resale. Id. at 831. CS1 told Burt that he 

did not have a legitimate medical need 

for drugs when he saw the Respondent 

at American Pain, and that during his 

office visit, the doctor did not 

physically touch him, but did tell him 

to bend over and touch his toes. Id. at 

832–33. The Government did not submit 

evidence of, or provide opposing 

counsel access to, a patient file 

reflecting CS1’s visit to the Respondent, 

a copy of the prescription allegedly 

issued, or the empty pill bottle 

described.31 Burt’s testimony divulged 

the fact that CS1’s cooperation with 

authorities was being provided in 

relation to his July 2009 arrest and that 

a record check revealed CS1 had arrests 

prior to that incident, though Burt was 

unable to recall information of any 

detail concerning the nature and 

disposition of those arrests. Id. at 1018– 

20. Burt declined to disclose the name 

of CS1 when queried on crossexamination.32 Id. at 1017. 

SA Burt also testified regarding the 

drug overdose deaths of TY and SM 

after obtaining controlled substances 

from American Pain.33 Burt’s record 

testimony indicates that DEA Task 

Force Officer 34 (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.35 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 

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36ALJ Ex. 6. 

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

Govt. Ex. 117. 38Tr. at 74. 

39At the consolidated hearing in this matter, the 

Government elicited testimony from Dr. Kennedy 

regarding additional aspects of practice that he 

found deficient regarding the prescribing practices 

of other respondents. For example, Dr. Kennedy 

opined that the prescribing of 30 mg of oxycodone 

to an opioid naı ̈ve patient would, in his opinion, 

be dangerous and improper. Similarly, Dr. Kennedy 

provided his opinion that the practice of ordering 

of an MRI prior to a physician meeting with a 

patient would be improper. However, regarding the 

charts that Dr. Kennedy reviewed relative to this 

Respondent, the government adduced no 

testimonial evidence regarding issues such as 

opioid naı ̈vete ́ or the timing of MRI scripts, and it 

would be unfair, improper and illogical for an 

Administrative Law Judge to extrapolate the 

testimony as noticed in the 

Government’s prehearing statement.36

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.37 Dr. Kennedy was offered by 

the Government and accepted as an 

expert in the field of pain medicine. Id. 

at 39. 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. Id. at 176–77, 

365. Dr. Kennedy stated that 

there was no true doctor/patient 

relationship established for the 

prescription of controlled substances at 

the first or any visit, and [] it was grossly 

deficient and medically dangerous to 

prescribe in the fashion it was 

prescribed for the same reasons. 

Id. Furthermore, Dr. Kennedy testified 

that after reviewing the charts, he 

concluded that the prescribing of 

controlled substances by the 

Respondent to the patients named in the 

charts was not for a legitimate medical 

purpose. Id. at 182. 

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 files 

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, during his testimony, Dr. 

Kennedy acknowledged that some level 

of standardization and utilization of 

forms is not, standing alone, 

improper,38 Dr. Kennedy took issue 

with what he perceived as flaws in the 

forms utilized by the Respondent to 

document patient care. Dr. Kennedy 

even acknowledged that the 

Respondent’s possession and use of 

stamps to affix prescription descriptions 

and doses on scripts, was not, standing 

alone, improper. Id. at 178. However, 

according to Dr. Kennedy, the forms 

employed by the Respondent were 

‘‘grossly deficient in that [they] didn’t 

really justify why the individual was 

given the high doses of narcotics or 

controlled substances that they were.’’ 

Id. at 177. 

Dr. Kennedy explained that there are 

basic elements to practicing pain 

medicine. The acquisition of a thorough 

history and physical examination is 

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

the vital importance of obtaining past 

medical records to evaluate what 

treatments, therapies, medications, and 

dosages have been utilized in the past 

so that correct current treatment 

decisions can be made. Id. at 45–46. 

Reliance upon the patient’s memory of 

these elements without the prior 

medical records, in Dr. Kennedy’s view 

is not reliable or acceptable. Id. at 46– 

47. Dr. Kennedy acknowledged that 

physicians customarily accept patients 

at their word, but on the subject of 

verifying a patient’s subjective 

complaint and medication history, Dr. 

Kennedy explained that 

[s]ometimes you have to help people 

understand why they’re suffering or 

what their problems are. A person with 

an addiction or drug abuse problem is 

no worse a human being than me. I’m 

not any better than them. But it’s your 

job as a doctor to sit down and find out 

what the truth is as well as you 

reasonably can under the circumstances. 

That wasn’t done here, in my opinion. 

Id. at 357. 

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 49. 

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 49–50. In other words, 

the diagnostic plan allows the treating 

doctor to eliminate or confirm items on 

the differential diagnosis. Id. at 50–52. 

Dr. Kennedy testified that in his 

expert opinion, the Respondent’s 

histories and physical examinations 

were ‘‘grossly deficient in that [the 

documentation] didn’t really justify why 

the [patient] was given the high doses of 

narcotics or controlled substance that 

they were.’’ Id. at 177. Kennedy stated 

that, in his view, the treatment plans 

evident in the charts were also defective 

because there was no individualized 

consideration apparent, that 

‘‘[e]verybody got essentially the same 

thing,’’ and that the treatment plans for 

all patients were invariably limited to a 

single option, i.e., ‘‘the treatment plan 

was to give controlled substances, and 

that was essentially it.’’ 39 Id. at 78. 

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testimony elicited relative to the patients of other 

physician(s) to this Respondent. See Gregg & Son 

Distribs., 74 FR 17517 n.1 (2009) (data should be 

provided while record is open, and ‘‘[t]o make clear, 

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’’) citing Southwood Pharms., Inc., 72 FR 

36487, 36503 n.25 (2007). The absence of 

testimonial support by Dr. Kennedy on these issues 

relative to this Respondent does not adversely affect 

the weight to be attached to the conclusions set 

forth in the reports he prepared in connection with 

this Respondent which were received into 

evidence. Govt. Exs. 28, 131. 

40Tr. at 63. 

41 During the prehearing proceedings, the 

Respondent moved for an order compelling 

production of, inter alia, all patient files seized 

from his office by the Government. The request 

(which was opposed by the Government) was 

denied in a separate order as ultra vires. ALJ Ex. 

20; see Nicholas A. Sychak, d/b/a Medicap 

Pharmacy, 65 FR 75959, 75961 (2000); Roy E. 

Berkowitz, M.D., 74 FR 3678, 36760 (2009). 

42At 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. 17. 

43 Govt. Ex. 28 at 4. 44 In Dr. Kennedy’s opinion, the Respondent 

‘‘prescribed, at the first visit, very high initial doses 

of controlled substance combinations despite not 

being within the standard of care for histories, 

physical examinations and/or absent past medical 

records [with] no apparent consideration given to 

patient safety with initial or subsequent 

prescription of controlled substance[s].’’ Govt. Ex. 

28 at 7. 

45 Govt. Ex. 28 at 4. 

46As 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. Govt. Ex. 28 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. 

47 Govt. Ex. 28 at 7. In Dr. Kennedy’s opinion, 

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

to receive appropriate medical evaluation and 

treatment. In other words, the very potent, high 

doses of opioids (oxycodone) and benzodiazepine 

(Xanax) may have masked or cover[ed] up [RZ’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. 

48 Govt. Ex. 28 at 7. 

49 Govt. Ex. 28 at 8. 

50 Govt. Ex. 28 at 7. 

51 Govt. Ex. 28 at 15. RZ’s chart did not contain 

a request for past medical records. Id. at 8. 

52 Govt. Ex. 28 at 14. 

53However, when pressed on the issue, Dr. 

Kennedy declined to identify any specific instance 

Continued 

Although Dr. Kennedy had earlier 

conceded that it is the judgment of the 

examining physician that is generally 

relied upon in determining the necessity 

and appropriateness of diagnostic 

testing,40 he also testified that, at least 

in his view, exclusive reliance on MRI 

procedures as the sole diagnostic tool is 

suboptimal, because they are not always 

required and not always appropriate. Id. 

at 75–77, 165–66. Kennedy 

characterized MRIs as the Respondent’s 

principal diagnostic tool. Id. at 177. 

Dr. Kennedy prepared two reports in 

connection with the Government’s case 

against the Respondent, both of which 

are dated April 30, 2010, and both of 

which were admitted into evidence 

during his testimony. Govt. Exs. 28, 131; 

Tr. at 174, 194. One of the reports 

describes a general analysis of seventeen 

charts that the Respondent maintained 

on as many patients, that were (selected 

by and) provided to Dr. Kennedy by the 

Government from among patient files 

seized pursuant to a criminal search 

warrant executed at the Respondent’s 

practice on March 3, 2010 (Patient 

Charts Analysis).41 Govt. Ex. 28. 

Although this report purports to 

describe practices common to all 

seventeen files reviewed by Dr. 

Kennedy, much of the analysis is 

directed toward a chart prepared in 

connection with RZ,42 one of the 

Respondent’s patients. A second report 

(Supplemental Chart Analysis) prepared 

by Dr. Kennedy focuses on the chart 

maintained under the name Luis Lopez, 

which was the assumed name of a law 

enforcement officer who visited the 

Respondent’s practice in an undercover 

capacity. Govt. Ex. 131; Tr. at 188, 335. 

Many of the observations and 

conclusions contained within the two 

reports are remarkably similar. Dr. 

Kennedy’s report makes it 

unambiguously clear that, at least in his 

opinion, all eighteen of the 

Respondent’s charts that he reviewed 

suffered from the same shortcomings. 

The Patient Charts Analysis states that 

the Respondent’s patient charts that Dr. 

Kennedy reviewed ‘‘are essentially the 

same with regard to review issues; as 

stated in the report of [RZ] referenced 

and discussed in this report in detail, 

[and that] there were no significant 

differences that affected [his] 

conclusions and summary.’’ Govt. Ex. 28 

at 2. A like-worded proviso 

accompanies Dr. Kennedy’s analysis of 

the chart prepared in connection with 

the undercover officer’s (Luis Lopez’s) 

interaction in the Supplemental Chart 

Analysis. Govt. Ex. 131 at 1. 

In Dr. Kennedy’s opinion, the patient 

charts he reviewed that were prepared 

by the Respondent reflected care that 

fell below the applicable standard on 

multiple levels. In his report, Dr. 

Kennedy noted that the treatment notes 

in the charts: (1) contained no 

typewritten clinical notes and were 

‘‘very brief, difficult to read (often 

impossible) and not within the standard 

of care due to their brevity and 

quality’’; 43 (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; 44 (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;’’ 45

(4) contained medication contracts that 

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

criteria that was not followed by the 

doctors at American Pain; 46 (5) failed to 

document the efficacy of the prescribed 

medication; (6) did not set forth a 

‘‘diagnostic plan, except to obtain an 

occasional MRI, the results of which 

made no difference in the 

‘treatment’’’; 47 (7) reflected ‘‘no 

therapeutic plan, except to use 

controlled substances to ‘treat’ the 

subjective complaint of ‘pain’ which 

was inadequately described; 48 (8) did 

not reflect ‘‘real therapeutic goals * * * 

for improvement of quality of life 

(activities of daily living, work, sleep, 

mood)’’; 49 (9) did not reflect 

‘‘consultations with other physicians or 

specialists outside the American Pain 

group [which] could have and in some 

cases should have included orthopedics, 

neurology, neurosurgery, psychiatry, 

addiction medicine and psychology’’; 50

(10) reflected ‘‘a gross lack of past 

medical records in all charts reviewed 

and in some cases none at all’’; 51 and, 

(11) demonstrated controlled substance 

patient monitoring practices that were 

‘‘not within the standard of care and 

outside the boundaries of professional 

practice.’’ 52

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.53 Govt. Ex. 28 at 14; Tr. at 

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regarding any of Respondent’s charts where he 

would have ordered an additional drug screen. Tr. 

at 180. 54 Govt. Ex. 28 at 15. 55 Govt. Ex. 28 at 13. 56 Govt. Ex. 28 at 8, 15. 57 Govt. Ex. 28 at 16. 

58 Given the testimony of SA Burt regarding the 

level of activity outside American Pain parking area 

as observed through the pole cam, it is remarkable 

that one patient actually indicated that one of the 

reasons she left the previous pain clinic she 

frequented was because of ‘‘people hanging outside 

place approaching patients for their medications.’’ 

Govt. Ex. 45 at 20. 

59Although a mathematically conceivable 

explanation for this discrepancy could be that the 

patient exhausted her prescribed clonazepam stock 

sufficiently in advance of the 11/12/09 testing so as 

to not register a positive reading, the chart should 

have reflected that the physician recognized, 

addressed, and documented this red flag regarding 

a potential abuse or diversion issue. 60 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. 

179–80. 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 outof-office toxicology tests, or obtain outof-state prescription monitoring 

program or outside pharmacy drug 

profiles. Furthermore, the charts 

contained only rare evidence of contact 

with primary care physicians, treating 

physicians, pharmacists, or other health 

care providers. Id. 

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. In 

addition to providing incomplete 

information on his patient 

questionnaires, the undercover officer 

(a/k/a Luis Lopez) admitted to the 

Respondent that he had previously 

purchased oxycodone on the street. 

Govt. Exs. 46 at 9, 131 at 3. Other red 

flags noted by Dr. Kennedy in the 

reviewed charts included the relatively 

young age (in Kennedy’s view) of the 

Respondent’s chronic pain patients,54

incomplete history information 

provided by the patients, periodically 

significant gaps between office visits,55

referrals from friends, relatives, or 

advertising, but not other physicians,56

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.57

At the hearing, Dr. Kennedy testified 

that the entries in some of the charts 

that reflected that the patients were 

acquiring controlled substances ‘‘off the 

street,’’ and urine drug screen results 

that were inconsistent with patient 

disclosures, were red flags that should 

have motivated a prudent physician to 

perform additional due-diligence steps, 

that, in addition to discussing the matter 

with the patient, could include reaching 

out to family members, previous treating 

physicians and pharmacists, obtaining 

past medical records, and additional 

testing. Tr. at 359–60, 362. Dr. Kennedy 

testified that his evaluation revealed 

that these red flags were present in the 

charts and precipitated no due-diligence 

actions on the Respondent’s part. Id. at 

360–64, 368–69. 

On the issue of red flags, WA’s patient 

file contains the Respondent’s 

handwritten notation indicating the 

patient acquired oxycodone and Xanax 

‘‘off [the] streets,’’ yet the Respondent 

authorized prescriptions for 

Roxicodone, Xanax, and Percocet to WA 

during his initial and subsequent visits. 

Govt. Ex. 29 at 11, 23–33. Like scenarios 

were also apparent in the charts of 

numerous other patients who had 

informed the Respondent that they had 

previously acquired such substances in 

this illegal manner, including the 

undercover law enforcement officer 

(Luis Lopez). See Govt. Exs. 30 at 7; 33 

at 4; 34 at 5; 37 at 1; 39 at 4; 40 at 1; 

46 at 9 (notations indicating patients 

acquiring controlled substances ‘‘off the 

street’’). Another patient file contained a 

similar note that the patient had 

received oxycodone ‘‘from [a] friend.’’ 

Govt. Ex. 44 at 13. 

KA’s patient file contains a form 

indicating a positive UDS for opiates 

and oxycodone from 7/9/09, yet on the 

same date, the patient comfort 

assessment guide and medication 

contract signed by KA are both blank in 

the section where a patient is supposed 

to list any medications he or she is 

currently taking. Govt. Ex. 30 at 14–15, 

33; see also Govt. Exs. 33 at 8–9, 23; 43 

at 10–11, 27 (similar issues). Patient JR’s 

5/27/[09] UDS indicates a negative test 

for all listed substances, yet on her 

signed medication contract from the 

same date, she indicates she is currently 

taking three substances which, though 

misspelled, appear to refer to 

oxycodone, Percocet, and Xanax, a 

discrepancy which raises questions 

about the validity of the testing 

procedures and/or the patient’s candor. 

Govt. Ex. 35 at 12, 26. Patient AZ’s 58

UDS form, on the other hand, lists 

positive test results for oxycodone and 

opiates only on 11/12/09, yet the patient 

claims on two different documents from 

the same date that, in addition to two 

different strengths of Roxicodone, she is 

also currently taking clonazepam, a 

benzodiazepine that should have 

triggered a positive reading for that 

substance on her drug screen.59 Govt. 

Ex. 45 at 9–10, 24. A prescribed 

controlled substance that is not reflected 

in a drug screen should have raised a 

sufficient suspicion of diversion to 

merit further inquiry by the registrant 

reflected in the patient file. At a 

minimum, these observations support 

the conclusion there was a general lack 

of vigilance on the part of the 

Respondent regarding his obligations as 

a registrant to minimize the risk of 

controlled substance diversion. 

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. 28 at 

3–4, 16. Dr. Kennedy’s report set forth 

his opinion that this practice was 

designed to ‘‘effectively keep [the 

physicians at American Pain] ‘off the 

radar’ from monitoring by any private 

health care insurance company as well 

as all state and federal agencies 

(Medicaid and Medicare respectively). 

Govt. Ex. 28 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. 

Notwithstanding the discomfiture that 

Dr. Kennedy expressed regarding nonphysician referrals in his report, during 

his testimony at the hearing he clarified 

that it was not unusual for a physician 

to treat patients that have been referred 

by relatives and friends. 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 recordevidence way to measure the relative 

percentage of physician referrals in the 

Respondent’s practice based on this 

limited sample of charts, the 

observations regarding referral sources 

are of limited value here.60

A review of the 18 patient files that 

informed the analysis, findings and 

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61The 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. 62Tr. at 628. 

63The Respondent did not testify on his own 

behalf. 

64This authority has been delegated pursuant to 

28 CFR 0.100(b) and 0.104. 

conclusions offered in Dr. Kennedy’s 

written report and testimony does 

reflect the presence of at least some of 

the red flag issues he identified therein, 

but there was not the unanimity among 

the files that he repeatedly urges. A 

review of the files reveals other 

treatment modalities beyond the 

exclusive regimen of controlled 

substances reflected in the selected 

patient charts urged by Kennedy in his 

report.61 Govt. Exs. 30 at 1; 34 at 1; 35 

at 1; 36 at 7; 38 at 3; 43 at 2; 44 at 2; 

36 at 6, 27. 

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. 28 at 16. 

On cross examination at the hearing, 

Dr. Kennedy’s attention was directed to 

what would seem, at least to a lay 

person, to present as including a 

significant level of detail set forth in the 

charts he reviewed relative to the 

Respondent’s patient documentation, 

including both subjective complaints of 

discomfort and objective signs of 

medical anomalies. Tr. at 214–27, 230, 

233–38, 243–44, 246–56, 262–66, 269– 

70, 273–87, 289–98, 305–08, 311–18, 

320–29, 332–47, 366. Even the file 

prepared in connection with the 

undercover officer’s interaction with the 

Respondent reflects recorded subjective 

complaints coupled with a remarkable 

MRI and other objective signs indicating 

some medical pathology. Id. at 335–47. 

Undaunted, Dr. Kennedy (the sole 

expert to testify at the hearing), 

remained committed to his position that 

the manner in which the documentation 

was completed was fundamentally 

insufficient for a physician to 

adequately proceed to treat the patients 

with controlled substances. Id. at 226– 

29, 231–32, 238–41, 258, 262, 264, 267– 

68, 286, 290, 299–301, 309–11, 342–43, 

366–67. Dr. Kennedy, more than once, 

succinctly stated that ‘‘[i]t’s not even 

close.’’ Id. at 268, 310. 

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,62 he was unable to identify the 

documentation standard in the Florida 

Administrative code with any degree of 

particularity, and he also acknowledged 

that he was not aware of what the 

standard is in Florida Medical Board 

administrative decisions regarding the 

overprescribing of medication or what 

constitutes an adequate medical history. 

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

Kennedy presented testimony that 

appeared candid and knowledgeable, 

there were areas in his written report 

that rang of hyperbole and overembellishment. The reasoning behind 

some of the seemingly critical 

observations in the written report, such 

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

practice and the absence of doctor 

referrals among the reviewed patient 

files, did not well survive the crucible 

of cross examination at the hearing. 

However, overall, Dr. Kennedy’s 

testimony was sufficiently detailed, 

plausible, and internally consistent to 

be considered credible, and, consistent 

with his qualifications, he spoke 

persuasively and with authority on 

some relevant issues within his 

expertise, and notwithstanding the 

Respondent’s objections relative to his 

Florida-related experience, he is 

currently an assistant professor teaching 

at a Florida Medical School. It may well 

be that the greatest and most significant 

aspect of Dr. Kennedy’s opinion is that 

on the current record, it stands 

unrefuted. Thus, his opinion is the only 

expert opinion available for reliance in 

this action.63 Consistent with his 

written report, Dr. Kennedy testified 

that from what he could glean in the 

charts he examined, the physical 

examinations were ‘‘grossly deficient in 

that [the physical examination] didn’t 

really justify why the individual was 

given the high doses of narcotics or 

controlled substances that they were,’’ 

that MRIs were the primary diagnostic 

tools and they should not have been, 

that the treatment plans were 

improperly ‘‘rubber stamped’’ with few 

modifications, and ‘‘there was no true 

doctor/patient relationship established 

for the prescription of controlled 

substances at the first of any visit, and 

that it was grossly deficient and 

medically dangerous to prescribe in the 

fashion it was prescribed for the same 

reasons.’’ Id. at 177–79. 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 64 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. 

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

‘‘[T]hese factors are considered in the 

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

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

combination of factors may be relied 

upon, and when exercising authority as 

an impartial adjudicator, the Deputy 

Administrator may properly give each 

factor whatever weight she deems 

appropriate in determining whether an 

application for a registration should be 

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

FR 43945 (1988); England Pharmacy, 52 

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

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

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

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

(1989). Moreover, the Deputy 

Administrator is ‘‘not required to make 

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

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

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

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

Deputy Administrator is not required to 

discuss consideration of each factor in 

equal detail, or even every factor in any 

given level of detail. Trawick v. DEA, 

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

Administrator’s obligation to explain 

the decision rationale may be satisfied 

even if only minimal consideration is 

given to the relevant factors and remand 

is required only when it is unclear 

whether the relevant factors were 

considered at all). The balancing of the 

public interest factors ‘‘is not a contest 

in which score is kept; the Agency is not 

required to mechanically count up the 

factors and determine how many favor 

the Government and how many favor 

the registrant. Rather, it is an inquiry 

which focuses on protecting the public 

interest * * * ’’ Jayam Krishna-Iyer, 

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

In an action to revoke a registrant’s 

DEA COR, the DEA has the burden of 

proving that the requirements for 

revocation are satisfied. 21 CFR 

1301.44(e). Once DEA has made its 

prima facie case for revocation of the 

registrant’s DEA Certificate of 

Registration, the burden of production 

then shifts to the Respondent to show 

that, given the totality of the facts and 

circumstances in the record, revoking 

the registrant’s registration would not be 

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

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

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

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

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

311 (1980). Further, ‘‘to rebut the 

Government’s prima facie case, [the 

Respondent] is required not only to 

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 can be 

entrusted with the responsibility 

commensurate with such a registration. 

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

(2009); Medicine Shoppe-Jonesborough, 

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

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

(2007). Normal hardships to the 

practitioner, and even the surrounding 

community, that are attendant upon the 

lack of registration are not a relevant 

consideration. Abbadessa, 74 FR at 

10078; see also Gregory D. Owens, 

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

The Agency’s conclusion that past 

performance is the best predictor of 

future performance has been sustained 

on review in the courts, Alra Labs. v. 

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

as has the Agency’s consistent policy of 

strongly weighing whether a registrant 

who has committed acts inconsistent 

with the public interest has accepted 

responsibility and demonstrated that he 

or she will not engage in future 

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

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

17543 (2009); Abbadessa, 74 FR at 

10078; Krishna-Iyer, 74 FR at 463; 

Medicine Shoppe, 73 FR at 387. 

While the burden of proof at this 

administrative hearing is a 

preponderance-of-the-evidence 

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

91, 100–01 (1981), the Deputy 

Administrator’s factual findings will be 

sustained on review to the extent they 

are supported by ‘‘substantial evidence.’’ 

Hoxie, 419 F.3d at 481. While ‘‘the 

possibility of drawing two inconsistent 

conclusions from the evidence’’ does not 

limit the Deputy Administrator’s ability 

to find facts on either side of the 

contested issues in the case, Shatz, 873 

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

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

such as a respondent’s defense or 

explanation that runs counter to the 

Government’s evidence, must be 

considered. Wedgewood Vill. Pharmacy 

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

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

ultimate disposition of the case must be 

in accordance with the weight of the 

evidence, not simply supported by 

enough evidence to justify, if the trial 

were to a jury, a refusal to direct a 

verdict when the conclusion sought to 

be drawn from it is one of fact for the 

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

quotation marks omitted). 

Regarding the exercise of 

discretionary authority, the courts have 

recognized that gross deviations from 

past agency precedent must be 

adequately supported, Morall, 412 F.3d 

at 183, but mere unevenness in 

application does not, standing alone, 

render a particular discretionary action 

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

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

Glover Livestock Comm. Co., Inc., 411 

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

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

Law Judge has had the opportunity to 

observe the demeanor and conduct of 

hearing witnesses, the factual findings 

set forth in this recommended decision 

are entitled to significant deference, 

Universal Camera Corp. v. NLRB, 340 

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

recommended decision constitutes an 

important part of the record that must 

be considered in the Deputy 

Administrator’s decision, Morall, 412 

F.3d at 179. However, any 

recommendations set forth herein 

regarding the exercise of discretion are 

by no means binding on the Deputy 

Administrator and do not limit the 

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

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

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

1974); Attorney General’s Manual on the 

Administrative Procedure Act 8 (1947). 

Factors 1 and 3: The Recommendation 

of the Appropriate State Licensing 

Board or Professional Disciplinary 

Authority and Conviction Record Under 

Federal or State Laws Relating to the 

Manufacture, Distribution, or 

Dispensing of Controlled Substances 

In this case, it is undisputed that the 

Respondent holds a valid and current 

state license to practice medicine. The 

record contains no evidence of a 

recommendation regarding the 

Respondent’s medical privileges by any 

cognizant state licensing board or 

professional disciplinary authority. 

However, that a state has not acted 

against a registrant’s medical license is 

not dispositive in this administrative 

determination as to whether 

continuation of a registration is 

consistent with the public interest. 

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

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

at 461. It is well-established Agency 

precedent that a ‘‘state license is a 

necessary, but not a sufficient condition 

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

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

35708 (2006). Even the reinstatement of 

a state medical license does not affect 

the DEA’s independent responsibility to 

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65The Respondent cites the Agency’s decision in 

Krishna-Iyer, 74 FR at 459–01 and the unpublished 

11th Circuit remand related to that case. KrishnaIyer v. DEA, No. 06–15034 (11th Cir. 2007), Slip Op. 

at 3. 

66Respt’s Br. at 3. 

determine whether a registration is in 

the public interest. Mortimer B. Levin, 

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

ultimate responsibility to determine 

whether a registration is consistent with 

the public interest has been delegated 

exclusively to the DEA, not to entities 

within state government. Edmund 

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

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

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

S.Ct. 1033 (2009). Congress vested 

authority to enforce the CSA in the 

Attorney General and not state officials. 

Stodola, 74 FR at 20375. Thus, on these 

facts, the fact that the record contains no 

evidence of a recommendation by a state 

licensing board does not weigh for or 

against a determination as to whether 

continuation of the Respondent’s DEA 

certification is consistent with the 

public interest. 

Similarly, regarding Factor 3, while 

testimony was received at the hearing 

that indicated that a criminal search 

warrant was executed regarding the 

Respondent and American Pain, the 

record contains no evidence that the 

Respondent has ever been convicted of 

any crime or even arrested in 

connection with any open criminal 

investigation. Thus, consideration of the 

record evidence under the first and 

third factors does not militate in favor 

of revocation. 

Factors 2, 4 and 5: The Respondent’s 

Experience in Dispensing Controlled 

Substances, Compliance with 

Applicable State, Federal or Local Laws 

Relating to Controlled Substances, and 

Such Other Conduct Which May 

Threaten the Public Health and Safety 

In this case, the gravamen of the 

allegations in the OSC, 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, notwithstanding the 

Respondent’s Krishna-Iyer-based 65

protestation in his brief that he has been 

somehow denied the ability to present 

‘‘positive experience in dispensing 

controlled substances,’’66 the 

Respondent introduced no evidence 

regarding his level of knowledge and 

experience, or even the quality or length 

of his experience as a physicianregistrant. The Government, on the 

other hand did elect to present evidence 

on the subject. 

Regarding the Government’s 

presentation, Agency precedent has long 

held that in DEA administrative 

proceedings that ‘‘the parameters of the 

hearing are determined by the 

prehearing statements.’’ CBS Wholesale 

Distribs., 74 FR 36746, 36750 (2009) 

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

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

M.D., 74 FR 36758, 36759–60 (2009) 

(‘‘pleadings in administrative 

proceedings are not judged by the 

standards applied to an indictment at 

common law’’ and ‘‘the rules governing 

DEA hearings do not require the 

formality of amending a show cause 

order to comply with the evidence’’). 

That being said, however, the marked 

difference between the amount of 

evidence that the Government noticed 

in its OSC/ISO and the amount that it 

ultimately 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,’’ 

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; 

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67The statutory definition of the term ‘‘dispense’’ 

includes the prescribing and administering of 

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

68ALJ Ex. 6 at 11–12. 

69Tr. at 825. 

70Tr. at 826. 

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] 

[t]here are signs within American Pain 

warning individuals not to have their 

prescriptions filed at Walgreens 

pharmacies [is] because Walgreens 

refuses to dispense the prescriptions; 

Walgreens has flagged all American 

Pain doctors and will not fill any of 

their prescriptions; 

[Physical exams at American Pain are] 

usually no more than a blood pressure 

check and some bending and stretching; 

Dismissed patients would be routed to 

other doctors within the clinic; 

[There was] co-mingling of [American 

Pain] physician’s drugs; 

[American Pain maintained] no 

inventories of drugs dispensed; 

[Details surrounding] the death of 

[American Pain] patient OB [where] 

[t]he cause of death was determined to 

be drug intoxication—opiate and 

benzodiazepine; 

[Information] from a confidential 

source [who indicated] that she traveled 

to American Pain in order to obtain 

controlled substances that were later 

sold in Kentucky for $25 per pill[,] [that] 

[the American Pain physician she 

encountered] did not spend any 

significant time conducting a physical 

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

simply ask questions regarding [her] 

well being and would then ‘‘stamp’’ a 

prescription for [controlled 

substances][,] * * * that on one visit 

[during a power failure a] security guard 

working for the clinic instructed 

everyone to be patient and that the 

doctors would be with them shortly to 

‘‘get your fix.’’ 

ALJ Ex. 6 at 3–9. 

To be clear, it is not that the evidence 

was introduced and discredited; no 

evidence to support these (and other) 

allegations was introduced at all. To the 

extent the Government had this 

evidence, it left it home. While the 

stunning disparity between the 

allegations proffered and those that 

were supported with any evidence does 

not raise due process concerns, it is 

worthy of noting, without deciding the 

issue, that Agency precedent has 

acknowledged the Supreme Court’s 

recognition of the applicability of the 

res judicata doctrine in DEA 

administrative proceedings. Christopher 

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

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

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

administrative agency is acting in a 

judicial capacity and resolves disputed 

issues of fact properly before it which 

the parties have had an adequate 

opportunity to litigate, the courts have 

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

The evidence the Government did 

present raises issues regarding not only 

Factor 2 (experience dispensing 67

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 5th 

largest practitioner purchaser of 

oxycodone in the United States.’’ 68 No 

evidence to support that allegation (or 

its relevance) was ever brought forth at 

the hearing. To the extent that fact may 

have been true or relevant, it was never 

developed. What’s more, the Florida 

Administrative Code specifically 

eschews pain medication prescribing 

analysis rooted only in evaluation of 

medication quantity. Fla. Admin. Code 

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

indication that despite Langston’s 

obvious qualifications to do so, that she 

or anyone else ever conducted an audit 

of the controlled-substance-inventoryrelated recordkeeping practices at 

American Pain. 

SA Burt testified that, during a 

temporally limited period of time, he 

observed some of the images captured 

by a pole camera positioned outside 

American Pain, and that he observed 

what in his view was a high percentage 

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

arguably provides some support for the 

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

dropped off by cars with out-of-state 

tags) were being seen at the clinic, but 

his testimony did not provide much else 

in terms of relevant information. In any 

event, recent Agency precedent holds 

that details such as ‘‘where [a 

registrant’s] patients were coming from,’’ 

without additional factual development, 

can support a ‘‘strong suspicion that [a] 

respondent was not engaged in a 

legitimate medical practice’’ but that 

‘‘under the substantial evidence test, the 

evidence must ‘do more than create a 

suspicion of the existence of the fact to 

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

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

NLRB v. Columbian Enameling & 

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

Likewise, without additional details 

or at least some context, Burt’s 

testimony that individuals with ‘‘staff’’ 

written on their shirts appeared to be 

directing patients into the clinic reveals 

virtually nothing about the 

Respondent’s prescribing practices. Tr. 

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,69 or advising them to 

comply with vehicle and traffic laws,70

does not shed illumination on the 

Respondent’s prescribing practices. 

There was neither evidence that the 

Respondent knew that these isolated 

incidents occurred, nor was there 

contextual evidence from which the 

relevance to these proceedings could be 

gleaned. Even if this tribunal was 

inclined to engage in the unsupported 

assignment of motives to the actions of 

these employees, under these 

circumstances, such an exercise could 

not constitute substantial evidence that 

could be sustained at any level of 

appeal. 

Burt’s testimony regarding his 

conversations with Dr. Sollie, who was 

formerly employed by American Pain, 

was also not received in a manner that 

could meaningfully assist in the 

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71Tr. at 898. 

72 In fact, the Government actually interposed an 

objection that exploration of this issue was beyond 

the scope of the direct examination. Tr. at 986. 

73ALJ Ex. 19 at 6. 

74ALJ Ex. 20. 

75 459 F.2d 1329, 1336 (D.C. Cir. 1972). 

76The applicability of the adverse inference rule 

is not dependent upon the issuance of a subpoena 

seeking to compel production. Int’l Union v. NLRB, 

459 F.2d at 1338. 

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,71

and that some patients were 

intentionally evading the American Pain 

urinalysis process. Sollie 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 evidence connected 

with Burt’s testimony concerning the 

undercover operations focused on the 

Respondent unfolded in a somewhat 

disquieting manner when viewed in 

context with the prior motion practice 

in this case. As a preliminary matter, it 

must be acknowledged that Burt’s 

testimony regarding the details of the 

Luis Lopez evolution, because it lacked 

detail, was of negligible import. Burt 

related that the UC told him that 

American Pain employees made 

statements and Burt viewed some 

statements on videotape, but there is no 

indication as to who the employees 

were, why Burt or the UC believed them 

to be employees, or what the basis for 

the directions to the patients were. For 

example, American Pain employees 

advising patients to avoid a particular 

pharmacy would doubtless have more 

relevance to these proceedings if the 

Government had presented any 

evidence that the pharmacy to be 

avoided (Walgreens) had some aversion 

to filling American Pain prescriptions. 

There was no such evidence. To the 

extent the Government was seeking to 

introduce the UC interaction evidence 

with a view toward reflecting on the 

Respondent’s prescribing practices, 

evidence regarding the details of the 

interaction between the Respondent and 

the UC would seem to have been 

imperative.72 This is particularly true 

here, where an MRI actually showed 

that the UC had a back impairment that 

could be treated by the use of the 

controlled substances prescribed by the 

Respondent. Thus, other than to provide 

contextual evidence concerning one of 

the patient charts reviewed by Dr. 

Kennedy, Burt’s testimony regarding the 

UC interaction does not advance the 

Government’s case for revocation. 

Of somewhat more concern is the 

procedural context of the UC-related 

portions of the Government’s case. 

During pre-hearing procedures, the 

Respondent sought discovery in the 

form of, inter alia, ‘‘[a]ll audio and video 

recordings pertaining to visits to 

American Pain during which the 

undercover officer was seen by [the 

Respondent].’’ ALJ Ex. 18 at 1. The 

Government correctly pointed out that, 

under the Administrative Procedure Act 

(APA) and Agency precedent, a 

discovery order is beyond the authority 

of this tribunal, but went on to argue 

that under Agency precedent ‘‘the only 

formal discovery required in DEA 

hearings is the exchange of documents 

and summarized testimony,’’ 73 and that 

the 

‘‘Respondent in this matter will be 

provided the documents and testimony 

to be used against him, and will be 

permitted to confront and cross examine 

witnesses and evidence presented by 

the Government at hearing.’’ 

Id. at 3. In a separate order (Discovery 

Denial Order),74 the discovery request 

was denied as ultra vires, and the 

Respondent’s attention was invited to 

explore other available procedural 

mechanisms, such as specific subpoena 

requests (none were submitted), 

applications to the United States District 

Court under Fed. R. Crim. P. 41(g), and, 

if warranted, the pursuit of the 

application of an evidentiary adverse 

inference before this tribunal. The 

Discovery Denial Order contained the 

following language: 

‘‘While discovery beyond the 

regulations is not a viable option 

available to the parties in this action, 

the position taken by the Government, 

if taken to its natural analytical 

conclusion, would allow it to 

intentionally seize exculpatory 

evidence, render it unavailable, and 

prevail in an administrative 

enforcement action that requires a due 

process hearing [with a footnote that 

added that] [t]here is no indication that 

such a scenario has taken place or 

would take place here. [The Order went 

on to state that] [w]hile the analytical 

simplicity of the Government’s position 

is facially appealing, it is unlikely that 

Congress, in enacting the APA and the 

Controlled Substances Act, intended 

such a result.’’ 

ALJ Ex. 20 at 7. Ironically, the precise 

scenario that this tribunal expressed 

confidence would not likely occur, is 

exactly the scenario that unfolded at the 

hearing. The Government seized the 

Respondent’s patient charts and 

proceeded under a theory that the 

Respondent inexorably prescribed 

controlled substances to essentially 

anyone posing as a patient who made a 

request. Through an agent who was illequipped to provide interaction details, 

the Government presented testimony 

that a UC who (at least by its theory) 

was not a legitimate candidate for a 

controlled substance prescription, 

received one from the registrant. It was 

only through the cross-examination 

performed by a co-Respondent’s counsel 

present at the consolidated hearing that 

it was revealed that another UC who 

attempted to procure controlled 

substances from this Respondent was 

refused. The Respondent (and this 

tribunal) have never been apprised of 

the details of the interaction or been 

given access to the patient chart 

regarding the rebuffed UC. 

In International Union (UAW) v. 

NLRB,75 the United States Court of 

Appeals for the District of Columbia 

Circuit held that the National Labor 

Relations Board committed reversible 

error by declining to apply the ‘‘adverse 

inference rule’’ where one of the parties 

had ‘‘relevant evidence within his 

control which he fail[ed] to produce.’’ 76

This precedent was embraced by the 

Eleventh Circuit in Callahan v. Schultz, 

783 F.2d 1543, 1545 (11th Cir. 1986). 

The judicious utilization of the adverse 

inference rule allows an administrative 

tribunal to use the tools available to it 

and ‘‘permits vindication of the 

tribunal’s authority in situations where 

vindication might, as a practical matter, 

be impossible otherwise.’’ Int’l Union, 

459 F.2d at 1339. Such an inference is 

appropriate under the circumstances of 

this case where the evidence of the 

unsuccessful UC was clearly within the 

Government’s control and should, to 

maintain the integrity of the 

proceedings, have been disclosed if not 

produced. Accordingly, an adverse 

interference will be applied here to the 

extent that is will be assumed in this 

recommended decision that, regarding 

the unsuccessful UC, his encounter with 

the Respondent reflected a correct and 

professional interaction memorialized 

by documentation that met with the 

standards set by the Florida Medical 

Board. Thus, the evidence regarding this 

unsuccessful UC, even if it had been 

provided to the Respondent, could have 

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77As evidenced by the ultimate disposition of 

this recommended decision, other evidence of 

record relating to the chart analysis by Dr. Kennedy 

was more successful in this regard. 

78 21 U.S.C. 823(f). 

79 ‘‘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). 

logically established no greater benefit 

to his litigation position. 

Furthermore, in this case, because SA 

Burt’s testimony regarding the UC’s 

interaction with the Respondent has 

been afforded no weight, the nonavailability of the details regarding the 

unsuccessful UC has resulted in no 

adverse impact regarding the 

Respondent’s case. This is ever so much 

more true where an adverse inference 

has resulted in the assumption that the 

only such credited interaction in the 

record was in all ways appropriate. Put 

another way, the Government’s attempt 

to show that the Respondent’s 

interaction with the successful UC 

demonstrated his proclivity to dole out 

controlled substances for insufficient 

reasons was not persuasive.77 However, 

if the testimonial vessel had delivered 

the testimony in a more effective 

fashion and the testimony regarding the 

successful UC had been credited, it 

seems that there was at least the 

potential for a significant compromise to 

the fairness of the adjudication. To the 

extent that a strained interpretation of 

the APA and existing DEA regulations 

have empowered the Government in 

espousing the position that it should 

rightfully be permitted to seize all 

potential evidence and dole back only 

those portions that adversely implicate 

the Respondent, that course is likely to 

result in precedent on judicial review 

that could impose unintended appellate 

consequences that could (and perhaps 

should) severely curtail its options in 

future enforcement actions. The point 

raised in the Respondent’s brief that 

‘‘[t]he Due Process Clause forbids an 

agency from using evidence in a way 

that forecloses an opportunity for a 

party to offer a contrary presentation,’’ 

Respt’s Br. at 3 (citing Volkman v. DEA, 

567 F.3d 215, 220 (6th Cir. 2009), is well 

taken. The APA guarantees that ‘‘[a] 

party is entitled to present his case or 

defense.’’ 5 U.S.C. 556(d). Irrespective of 

the number of assurances provided by 

the Government that a respondent will 

be afforded all the rights to which he is 

entitled, the practice of seizing all 

evidence from a Respondent, presenting 

a selective compilation of that which 

tends to disparage his case, while 

denying access to information from 

which he could meaningfully defend 

against the allegations, does not have a 

strong likelihood of ratification on 

appeal. More importantly, when brought 

to its logical end, it could tend to 

undermine the integrity of the 

adjudication in the eyes of the public. 

That no cognizable prejudice was 

realized to this Respondent’s ability to 

present his case here does not enhance 

the wisdom of the procedural course 

embarked upon. That being said, no 

prejudice resulted to the Respondent 

here. 

The Government’s evidence at the 

hearing targeted not only the 

Respondent’s experience practicing 

under Factor 2, but also his compliance 

with applicable state and federal laws 

relating to controlled substances under 

Factor 4. To effectuate the dual goals of 

conquering drug abuse and controlling 

both legitimate and illegitimate traffic in 

controlled substances, ‘‘Congress 

devised a closed regulatory system 

making it unlawful to manufacture, 

distribute, dispense, or possess any 

controlled substance except in a manner 

authorized by the CSA.’’ Gonzales v. 

Raich, 545 U.S. 1, 13 (2005). Consistent 

with the maintenance of that closed 

regulatory system, subject to limited 

exceptions not relevant here, a 

controlled substance may only be 

dispensed upon a prescription issued by 

a practitioner, and such a prescription is 

unlawful unless it is ‘‘issued for a 

legitimate medical purpose by an 

individual practitioner acting in the 

usual course of his professional 

practice.’’ 21 U.S.C. 829; 21 CFR 

1306.04(a). Furthermore, ‘‘an order 

purporting to be a prescription issued 

not in the usual course of professional 

treatment * * * is not a prescription 

within the meaning and intent of [21 

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

* * * issuing it, shall be subject to the 

penalties provided for violations of the 

provisions of law related to controlled 

substances.’’ Id. 

A registered practitioner is authorized 

to dispense,78 which the CSA defines as 

‘‘to deliver a controlled substance to an 

ultimate user 79 * * * 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, 567 F.3d at 223 

(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 

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80Rulemaking 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). 

81Florida 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). 

82Pursuant 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). 83 21 CFR 306.04(a). 

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,80 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,81

provided the physician does so in 

accordance with that level of care, skill, 

and treatment recognized by a 

reasonably prudent physician under 

similar conditions and circumstances. 

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

the Florida Board has adopted,82 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,’’ 83 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 

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84The 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. 

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 84 medical history and 

physical examination must be 

conducted and documented in the 

medical record. The medical record 

should document the nature and 

intensity of the pain, current and past 

treatments for pain, underlying or 

coexisting diseases or conditions, the 

effect of the pain on physical and 

psychological function, and history of 

substance abuse. The medical record 

also should document the presence of 

one or more recognized medical 

indications for the use of a controlled 

substance. 

Id. at 9.013(3)(a). 

Furthermore, the Florida Standards 

require a written treatment plan that 

‘‘should state objectives that will be 

used to determine treatment success, 

such as pain relief and improved 

physical and psychosocial function, and 

should indicate if any further diagnostic 

evaluations or other treatments are 

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

to the initiation of treatment, ‘‘the 

physician should adjust drug therapy to 

the individual medical needs of each 

patient. Other treatment modalities or a 

rehabilitation program may be necessary 

depending on the etiology of the pain 

and the extent to which the pain is 

associated with physical and 

psychosocial impairment.’’ (emphasis 

supplied). Id. 

Another standard adopted by the 

Florida Board, under the subheading 

‘‘Informed Consent and Agreement for 

Treatment,’’ is the directive that 

[t]he physician should discuss the risks and 

benefits of the use of controlled substances 

with the patient, persons designated by the 

patient, or with the patient’s surrogate or 

guardian if the patient is incompetent. The 

patient should receive prescriptions from one 

physician and one pharmacy where possible. 

If the patient is determined to be at high risk 

for medication abuse or have a history of 

substance abuse, the physician should 

employ the use of a written agreement 

between the physician and patient outlining 

patient responsibilities, including, but not 

limited to: 

1. Urine/serum medication levels screening 

when requested; 

2. Number and frequency of all 

prescription refills; and 

3. Reasons for which drug therapy may be 

discontinued (i.e., violation of agreement. 

Id. at 9.003(3)(c). 

The Florida Standards contain a 

further requirement to periodically 

review ‘‘the course of pain treatment and 

any new information about the etiology 

of the pain or the patient’s state of 

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

Standards explain the importance of 

periodic review in the following 

manner: 

Continuation or modification of 

therapy depends on the physician’s 

evaluation of the patient’s progress. If 

treatment goals are not being achieved, 

despite medication adjustments, the 

physician should reevaluate the 

appropriateness of continued treatment. 

The physician should monitor patient 

compliance in medication usage and 

related treatment plans. 

Id. 

Under the subheading ‘‘Consultation,’’ 

the Florida Board promulgated the 

instruction that 

[t]he physician should be willing to 

refer the patient as necessary for 

additional evaluation and treatment in 

order to achieve treatment objectives. 

Special attention should be given to 

those pain patients who are at risk for 

misusing their medications and those 

whose living arrangements pose a risk 

for medication misuse or diversion. The 

management of pain in patients with a 

history of substance abuse or with a 

comorbid psychiatric disorder requires 

extra care, monitoring, and 

documentation, and may require 

consultation with or referral to an expert 

in the management of such patients. 

Id. at 9.003(3)(e). 

It is abundantly clear from the plain 

language of the Florida Standards that 

the Florida Board places critical 

emphasis on physician implementation 

of adequate safeguards in their practice 

to minimize diversion and the need to 

document the objective signs and 

rationale employed in the course of pain 

treatment utilizing the prescription of 

controlled substances. Conscientious 

documentation is repeatedly 

emphasized as not just a ministerial act, 

but a key treatment tool and a vital 

indicator to evaluate whether the 

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). 

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 

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(1975) (‘‘silence gains more probative 

weight where it persists in the face of 

accusation, since it is assumed in such 

circumstances that the accused would 

be more likely than not to dispute an 

untrue accusation.’’)); Joseph 

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

n.3 (2009) (citing Ohio Adult Parole 

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

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

the allegations are of a nature that a 

registrant would be more likely than not 

to dispute them if untrue, an adverse 

inference based on the Respondent’s 

silence is appropriate. Where, as here, 

the Government, through its expert, has 

alleged that the Respondent’s charts do 

not reflect genuine analysis, but rather 

(at least in its view and the opinion of 

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

form designed specifically to present a 

false impression of a compliant 

registrant, it is precisely the type of 

allegation that would naturally all but 

oblige a registrant to spring to offer a 

contradictory account. The 

Respondent’s choice to remain silent in 

the face of such allegations, where he 

could have related his version of his 

practice as a registrant, adds at least 

some additional credence to the factual 

and analytical views of the 

Government’s expert in this regard. 

In the Social Security context, where 

an Administrative Law Judge has 

received expert medical opinions on the 

issue of the claimant’s ability to work 

and they are not repudiated in any 

respect by substantial evidence, an 

adverse decision should be set aside as 

based on ‘‘suspicion and speculation.’’ 

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

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

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

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

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

to reject uncontroverted evidence 

supporting complaints of pain simply 

because of claimant’s demeanor at 

hearing). When an administrative 

tribunal elects to disregard the 

uncontradicted opinion of an expert, it 

runs the risk of improperly declaring 

itself as an interpreter of medical 

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

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

it is ironically true, much like in the 

Social Security context, that the opinion 

of a treating physician should be 

afforded greater weight than the opinion 

of an expert whose opinion is limited to 

a review of the patient file, see 

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

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

Respondent in this case offered no 

evidence, not even his own opinion, 

regarding the treatment rendered. Thus, 

in this adjudication, the record contains 

no dispute between experts to be 

resolved; instead, there is but one, 

unrefuted, uncontroverted, credible 

expert opinion. To ignore that expert 

opinion on this record and replace it 

with the opinion of this tribunal, 

Respondent’s counsel, or any other lay 

source would be a dangerous course and 

more importantly, a plainly erroneous 

one. 

Accordingly, after carefully balancing 

the admitted evidence, even applying an 

adverse inference that permits the 

assumption that the Respondent was 

approached by an undercover agent and 

acted appropriately, the evidence 

establishes, by a preponderance, that the 

prescriptions the Respondent issued in 

Florida were not issued within ‘‘the 

usual course of [the Respondent’s] 

professional practice.’’ 21 CFR 

1306.04(a). Consideration of the 

evidence under the second and fourth 

factors support the COR revocation 

sought by the Government in this case. 

To the extent that the Respondent’s 

prescribing practices fell below the 

requisite standard in Florida, that 

conduct also impacts upon the Fifth 

statutory factor. Under Factor 5, the 

Deputy Administrator is authorized to 

consider ‘‘other conduct which may 

threaten the public health and safety.’’ 

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

authorizes consideration of a somewhat 

broader range of conduct reaching 

beyond those activities typically 

associated with a registrant’s practice, 

an adverse finding under this factor 

requires some showing that the relevant 

conduct actually constituted a threat to 

public safety. See Holloway Distrib., 72 

FR 42118, 42126 (2007). 

The evidence establishes that the 

Respondent engaged in a course of 

practice wherein he prescribed 

controlled substances to patients 

irrespective of the patients’ need for 

such medication and ignoring any and 

all red flags that could or did indicate 

likely paths of diversion. The testimony 

of Dr. Kennedy, the DEA regulations, 

and the Florida Standards make clear 

that physicians prescribing controlled 

substances do so under an obligation to 

monitor the process to minimize the risk 

of diversion. The patient charts reflect 

that the Respondent, contrary to his 

obligations as a DEA registrant, did not 

follow up in the face of multiple red 

flags. The Respondent’s disregard of his 

obligations as a DEA registrant and 

Federal and State laws related to 

controlled substances militate in favor 

of revocation. 

By ignoring his responsibilities to 

monitor the controlled substance 

prescriptions he was authorizing to 

minimize diversion, and by 

participating in an insufficiently 

documented and thoughtful process for 

the issuance of potentially dangerous 

controlled substances, the Respondent 

created a significant potential conduit 

for the unchecked diversion of 

controlled substances. See Holloway 

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

no evil, hear no evil’’ is fundamentally 

inconsistent with the obligations of a 

DEA registrant). Agency precedent has 

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

absolutely no difference between the 

sale of an illicit drug on the street and 

the illicit dispensing of a licit drug by 

means of a physician’s prescription.’’ 

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

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

(1988). 

Agency precedent has consistently 

held that where, as here, the 

Government has met its burden to 

establish a prima facie case that a 

registrant has committed acts 

demonstrating that continued 

registration is inconsistent with the 

public interest, acceptance of 

responsibility is a condition precedent 

to continued registration. Jeri Hassman, 

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

Shoppe, 73 FR at 387. The record 

contains no evidence that the 

Respondent has either acknowledged or 

accepted responsibility for the 

misconduct at issue in these 

proceedings. 

Recommendation 

Based on the foregoing, the evidence 

supports a finding that the Government 

has established that the Respondent has 

committed acts that are inconsistent 

with the public interest. A balancing of 

the statutory public interest factors 

supports the revocation of the 

Respondent’s Certificate of Registration 

and a denial of his application to renew. 

The Respondent has not accepted 

responsibility for his actions, expressed 

remorse for his conduct at any level, or 

presented evidence that could 

reasonably support a finding that the 

Deputy Administrator should continue 

to entrust him with a Certificate of 

Registration. Accordingly, the 

Respondent’s Certificate of Registration 

should be revoked and any pending 

applications for renewal should be 

denied. 

Dated: August 10, 2010. 

John J. Mulrooney II, 

U.S. Administrative Law Judge. 

[FR Doc. 2011–8344 Filed 4–6–11; 8:45 am] 

BILLING CODE 4410–09–P 

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