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MacKay v. Dea, 10-9556 (2011)

Court: Court of Appeals for the Tenth Circuit Number: 10-9556 Visitors: 57
Filed: Dec. 23, 2011
Latest Update: Feb. 22, 2020
Summary: FILED United States Court of Appeals Tenth Circuit December 23, 2011 Elisabeth A. Shumaker Clerk of Court PUBLISH UNITED STATES COURT OF APPEALS TENTH CIRCUIT DEWEY C. MACKAY, M.D., Petitioner, v. No. 10-9556 DRUG ENFORCEMENT ADMINISTRATION, Respondent. ON PETITION FOR REVIEW OF A DECISION BY THE DRUG ENFORCEMENT ADMINISTRATION (DEA No. 09-28) Peter Stirba (Nathan A. Crane and Miles W. Millard with him on the briefs) of Stirba & Associates, Salt Lake City, Utah, for Petitioner. Anita J. Gay, Att
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                                                                     FILED
                                                         United States Court of Appeals
                                                                 Tenth Circuit

                                                             December 23, 2011
                                                             Elisabeth A. Shumaker
                                                                 Clerk of Court
                                  PUBLISH

              UNITED STATES COURT OF APPEALS

                             TENTH CIRCUIT



 DEWEY C. MACKAY, M.D.,

       Petitioner,

 v.
                                                       No. 10-9556
 DRUG ENFORCEMENT
 ADMINISTRATION,

       Respondent.


                      ON PETITION FOR REVIEW
                       OF A DECISION BY THE
                DRUG ENFORCEMENT ADMINISTRATION
                           (DEA No. 09-28)


Peter Stirba (Nathan A. Crane and Miles W. Millard with him on the briefs) of
Stirba & Associates, Salt Lake City, Utah, for Petitioner.

Anita J. Gay, Attorney, United States Department of Justice, Criminal Division,
Narcotic and Dangerous Drug Section, Washington, D.C., for Respondent.


Before BRISCOE, Chief Judge, and SEYMOUR, and LUCERO, Circuit Judges.


SEYMOUR, Circuit Judge.
      Dewey C. MacKay, M.D., petitions for review of a decision of the Deputy

Administrator of the Drug Enforcement Administration (“DEA”) revoking his

registration to dispense controlled substances and denying all pending requests for

renewal or modification. 1 Dewey C. MacKay, M.D., 75 Fed. Reg. 49,956 (DEA

Aug. 16, 2010). Because the DEA’s decision is supported by substantial evidence

and is not arbitrary or capricious, we deny the petition.



                                         I.

      Dr. MacKay is a medical doctor who, at the time of the underlying

proceedings, held a DEA certificate of registration that authorized him to

dispense controlled substances in schedules II through V. 2 He also held a

physician’s license issued by the State of Utah and has been a board-certified

orthopedic surgeon for over thirty years.

      Around 2001, Dr. MacKay underwent cardiac bypass surgery. Thereafter,

      1
       The Controlled Substances Act requires persons who dispense controlled
substances to obtain proper registration from the Attorney General. See 21 U.S.C.
§ 822(a)(2). The authority to deny, revoke, or suspend administrations has been
delegated to the Administrator of the DEA, see 21 U.S.C. § 824; 28 C.F.R.
§ 0.100(b), and redelegated to the Deputy Administrator, see 28 C.F.R. § 0.104 &
App. § 12.
      2
        The Controlled Substances Act classifies controlled substances in five
schedules. Substances in schedules II through V have accepted medical uses in
the United States and may be dispensed (prescribed) by physicians registered with
the DEA. See 21 U.S.C. § 812. Drugs in lower numbered schedules have a
higher abuse potential. See 
id. Updated schedules
of controlled substances are
published in the Code of Federal Regulations. See 21 C.F.R. §§ 1308.11-.15.

                                         -2-
he gradually reduced the number of surgeries he performed, until he stopped

performing surgeries altogether around 2006. As Dr. MacKay decreased his

orthopedic surgical practice, he began treating chronic pain patients. By 2007,

approximately eighty-five percent of his practice involved pain patients. This

case concerns his prescribing behavior from 2005 to early 2009, when his practice

focused primarily on chronic pain management.

                                         A.

      The DEA began investigating Dr. MacKay after receiving information from

local authorities that he was issuing unlawful prescriptions for controlled

substances. As part of this investigation, the DEA interviewed several of Dr.

MacKay’s former patients and executed search warrants on his office in June

2008 and January 2009, seizing patient records and related documents. In

addition, the DEA gained cooperation of patients M.R. and K.D., both of whom

agreed to record undercover visits with Dr. MacKay. They recorded a total of

eight in-person visits and one phone call with Dr. MacKay, from October 2007 to

December 2008. 3

      On February 26, 2009, the Deputy Administrator of the DEA issued an

order to show cause why the DEA should not revoke Dr. MacKay’s registration


      3
        In particular, M.R. recorded visits on October 9, November 27, December
24, 2007, and January 29, 2008. K.D. recorded visits on November 3, November
24, December 1, and December 22, 2008, and a phone call on November 20,
2008.

                                        -3-
on the ground that his continued registration is inconsistent with the public

interest. See 21 U.S.C. §§ 823(f); 824(a)(4). The order stated that Dr. MacKay’s

registration would be immediately suspended, pending the show cause

proceedings. 4

      The order to show cause alleged that from “June 2005 to the present,” Dr.

MacKay “issued numerous purported prescriptions for controlled substances

without a legitimate medical purpose and outside the usual course of professional

practice.” MacKay, 75 Fed. Reg. at 49,956 (quoting Order to Show Cause at 1-2)

(internal quotation marks omitted). As factual support, the order asserted, among

other things, that Dr. MacKay had issued prescriptions for controlled substances

to a patient even after she told him she shared her prescription drugs with another

person, had exchanged prescription drugs for sexual favors, had issued

prescriptions for controlled substances without a legitimate medical purpose and

without conducting appropriate diagnostic evaluations, and had been prescribing

extraordinarily large amounts of highly addictive opioids.

      Dr. MacKay filed a motion for a temporary restraining order in federal

district court, seeking reinstatement of his registration. After holding a hearing,

the district court stayed the immediate suspension of Dr. MacKay’s registration


      4
        The Controlled Substances Act authorizes immediate suspension of a
physician’s registration at the commencement of show cause proceedings if the
DEA finds “there is an imminent danger to the public health or safety.” 21
U.S.C. § 824(d).

                                         -4-
pending a final administrative decision on the underlying order to show cause.

Based on the limited evidence then in the record, the court held the DEA had not

demonstrated that Dr. MacKay’s continued registration would result in “imminent

danger to public health or safety,” as required for immediate suspension. See 21

U.S.C. § 824(d).

                                        B.

      After the district court issued its order, an administrative law judge (“ALJ”)

held a hearing at which both sides presented evidence. The DEA’s evidence

included testimony of cooperating patients M.R. and K.D., audio-recordings and

transcripts of their undercover conversations with Dr. MacKay, medical records

of several patients, and testimony of Dr. Bradford Hare, a medical expert.

      M.R. was Dr. MacKay’s patient from May 2004 through January 2008.

When she began seeing Dr. MacKay, it was for “wrist pain.” Later her

complaints shifted to “back pain.” However, she testified that her pain

complaints were fabricated. Instead, she went to see Dr. MacKay to obtain

prescriptions for Lortab to use for recreational purposes. According to M.R., Dr.

MacKay conducted no examination on her first visit, except for feeling her wrist

for about ten seconds. Similarly, when she feigned back pain, the extent of Dr.

MacKay’s examination was to ask her to bend over and stand up again. He never

ordered any tests or X-rays to diagnose or verify her claimed ailments. M.R.

explained that during her appointments, she was not asked to discuss her pain at

                                        -5-
all before Dr. MacKay gave her prescriptions for controlled substances. She

mentioned her pain to him only two or three times over several years. Yet she

consistently received prescriptions for controlled substances including Lortab,

Valium, and Xanax.

      M.R.’s recorded undercover appointments corroborate her testimony.

During her first such appointment, M.R. was accompanied by an undercover DEA

agent posing as her friend, “Rebecca.” Rebecca and M.R. attempted to obtain a

Lortab or OxyContin prescription for Rebecca. Dr. MacKay refused to write a

prescription for her without a referral from her doctor and an appointment. The

entire appointment focused on whether Dr. MacKay would write a prescription for

Rebecca; there was no discussion of M.R.’s pain or medical condition.

Nevertheless, M.R. emerged from the appointment with a prescription for ninety

Lortab with a refill.

      During M.R.’s second undercover visit, Dr. MacKay asked her, “How are

you today?” She replied, “Good. How are you?” Dr. MacKay did not ask any

questions about her pain, but said, “You want a refill again?” She replied,

“Yeah.” MacKay, 75 Fed. Reg. at 49,965. 5 During this appointment, M.R. told

      5
        The administrative record was submitted to this court with a motion to
seal the documents and exhibits contained therein because the documents reveal
medical records and private personal information about Dr. MacKay’s patients.
The unopposed motion was provisionally granted. We now permanently grant the
motion and allow the administrative record to remain under seal. Because the
administrative record is sealed, we instead quote from the Deputy Administrator’s
                                                                       (continued...)

                                        -6-
Dr. MacKay that she had shared some of her drugs with Rebecca. She asked him

whether that was “okay to do.” Dr. MacKay told her that was “against the

law. . . . Just don’t, uh, don’t tell me about it.” 
Id. Despite knowing
that she was

diverting drugs, Dr. MacKay gave her another prescription for ninety Lortab with

one refill.

       At M.R.’s third undercover appointment, Dr. MacKay told her that although

he had been seeing her about once a month, she needn’t come back for two

months because he was going to give her a prescription and a refill. He then

asked her, “Lortab ten?” M.R. replied, “Yeah.” 
Id. After the
sound of paper

tearing from a pad, Dr. MacKay asked her, “You been doing okay?” M.R. said,

“Yeah. I’m doing good.” 
Id. There was
no discussion of M.R.’s pain or the

efficacy of her medication and no physical examination. She left the appointment

with a prescription for ninety Lortab and a refill.

       M.R.’s fourth undercover visit was about a month later. Dr. MacKay began

the appointment by asking how she was doing. She replied, “Good. How are

you?” He said, “Good,” then asked her, “Lortab ten #90?” 
Id. After she
said

yes, he also asked her if she wanted a refill, to which she again replied, “Yes.”

Dr. MacKay asked M.R. whether she was “getting pills from any other doctor,”

and whether she was “abusing them, selling them, buying them” or “doing


       5
           (...continued)
decision, which is not sealed. In so doing, we omit all internal quotation marks.

                                          -7-
anything illegal?” 
Id. (alteration omitted).
She said she was not. He did not

mention that she had come back a month earlier than she was supposed to. He did

not inquire about her pain, nor does the transcript suggest a physical exam was

performed. Nevertheless, M.R. again emerged from the appointment with a

Lortab prescription and a refill.

      Dr. Hare, the DEA’s expert witness, reviewed the transcripts of M.R.’s

recorded appointments. As he testified, M.R.’s appointments were more social

than medical with little, if any, discussion of her medical condition. Dr. Hare

compared the transcripts of M.R.’s undercover visits with her patient records for

those appointments. He explained that although the medical records indicated

physical examinations were conducted during her appointments, it appeared from

the transcripts that no such exams occurred.

      According to Dr. Hare, although the usual course of professional practice

requires a physician to document the justification for switching between

controlled substances, Dr. MacKay failed to provide such justification when

changing M.R.’s prescriptions. Dr. Hare testified that Dr. MacKay’s records were

superficial, with little useful information beyond the nature of her complaint.

They did not even indicate whether his treatment improved her condition. Dr.

Hare also noted that documents in M.R.’s file show Dr. MacKay was aware she

was receiving duplicate prescriptions for controlled substances from another

doctor, suggesting M.R. was overusing or abusing her medication. Despite these

                                         -8-
indications of diversion, Dr. Hare saw no changes in Dr. MacKay’s prescribing

practices to address the problem. In Dr. Hare’s view, M.R.’s medical records did

not “support the long-term prescribing of controlled substances” to M.R. 
Id. at 49,966.
      K.D. was Dr. MacKay’s patient beginning in November 2004. K.D.

testified that she had a legitimate pain condition when she began seeing Dr.

MacKay for a neck injury, but she said Dr. MacKay performed no tests or X-rays

to diagnose her neck pain. 6 Other than a brief examination during her first

appointment, he never performed another physical exam on her. According to her

testimony, after the first appointment if her pain was discussed at all, it was

because she raised the subject. She testified that she was addicted to pain

medication and that ninety percent of the medication she received from Dr.

MacKay was for recreational use.

      K.D. also testified that Dr. MacKay engaged in sexual activities with her on

multiple occasions. For their first encounter, he asked her to meet him at a motel

room, where he gave her a topless massage and then wrote her a prescription for a

controlled substance. The government presented a receipt showing Dr. MacKay’s

payment for the motel room to corroborate K.D.’s account. K.D. testified that she



      6
         This statement was contradicted by evidence in her medical record
indicating that Dr. MacKay took an X-ray of K.D.’s neck in 2004 to evaluate her
initial complaint of neck pain.

                                         -9-
and Dr. MacKay met four or five other times at her friend’s house. During these

encounters, he gave her topless massages and once digitally penetrated her; he

also gave her prescriptions for controlled substances and, on some occasions,

money for filling the prescriptions.

      The recordings of K.D.’s appointments with Dr. MacKay reflect a lack of

evaluation of her medical needs. At the first undercover visit, K.D. told Dr.

MacKay that she had “been in a lot of pain.” Dr. MacKay responded only by

commenting, “I’ll bet you have,” 
id. at 49,968,
and by asking her what drugs she

wanted. She recited the drugs and quantities she wanted. No further inquiries

were made into how well her medication was working, whether the source or

severity of her pain had changed since her last appointment, or any side effects

she might be experiencing. Instead, Dr. MacKay expressed concern that he was

under investigation by the DEA and asked her if she was a plant from the police

or the DEA. He told her the DEA had “actually sent people in with wires.” 
Id. at 49,969.
Despite knowing the DEA was investigating his office, Dr. MacKay gave

K.D. prescriptions for 90 tablets of OxyContin 40 mg., 120 tablets of oxycodone

30 mg., 30 tablets of Ambien, and 60 tablets of Fioricet.

      Three weeks later, on November 24, 2008, K.D. returned for another

appointment, which was also recorded. After she discussed problems she had

encountered filling a prescription, which she ultimately received in its entirety,

Dr. MacKay explained that he could not write a refill for her “less than four

                                        -10-
weeks” after her last visit, or before December 1. 
Id. He told
her he would give

her sixty oxycodone to carry her through Thanksgiving, and she could come back

December 1 for the rest. He promised not to bill her for the next appointment.

He then asked her “And you’re not working with the DEA, or wearing a wire,

right?” 
Id. She said
she was not. During the rest of the appointment, they

discussed the DEA investigation and Dr. MacKay’s dispute with his former

business partner. There is no indication he performed an exam or asked any

questions about K.D.’s pain.

      K.D. returned on December 1, 2008. Dr. MacKay asked what she needed,

and she replied, “Everything. My OxyContin, my Roxicet, my Fioricet, my

Ambien, and I have been so stressed out, so I was going to see if I could get some

Xanax, too.” 
Id. Dr. MacKay
asked her how many Xanax she wanted. They

decided thirty would be good. He warned her that with Xanax, Soma, Klonopin,

and Ambien she would run the risk of over sedating.

      The rest of the appointment was spent discussing personal issues. They

both complained about their money troubles, and Dr. MacKay talked about the

DEA’s investigation. Dr. MacKay asked K.D. whether he had her newest phone

number and promised her that “if anything goes better for me I’ll . . . give you a

call.” 
Id. K.D. complained
about how swollen her neck was and said “I need a

massage.” Dr. MacKay replied, “Right through there, yeah.” K.D. then asked,

“That means no more massages? No more help – at all?” Dr. MacKay laughed

                                        -11-
and later told her, “Well, let’s see if things get any better for us here.” 
Id. K.D. then
asked Dr. MacKay if one of his employees “get[s] mad that I

close the door?” 
Id. (alteration in
original). He told her, “She does. She thinks

your [sic] doing nasty things in here.” K.D. replied, “[N]o, I would never do that.

. . . Well, not in the office.” 
Id. (second alteration
in original). After discussing

personal issues a bit more, the appointment ended. K.D. left with prescriptions

for 90 tablets of OxyContin 40 mg., 120 tablets of oxycodone 30 mg., 30 tablets

of Xanax, and 60 tablets of Fioricet.

      During the four years K.D. was Dr. MacKay’s patient, the number of

controlled substances he prescribed for her escalated, along with their dosages.

Dr. Hare testified there was nothing in Dr. MacKay’s file on K.D. to justify the

changes in drugs that he was prescribing for her. Similarly, when Dr. MacKay

changed his recorded diagnosis of K.D.’s ailment from cervical spine pain to low

back pain, Dr. Hare found no indication that Dr. MacKay conducted any

evaluation to warrant the change in diagnosis. Dr. Hare testified Dr. MacKay’s

notes were “quite superficial on the initial evaluation, [and had] very little in the

way of history or physical exam . . . .” 
Id. at 49,972.
According to Dr. Hare,

K.D.’s medical records were inadequate to justify the prescribing of controlled

substances.

      Dr. Hare also found in Dr. MacKay’s files numerous common indicators

that K.D. was abusing drugs. Her file contained reports from the State of Utah

                                          -12-
showing she was receiving controlled substances from multiple physicians and

multiple pharmacies at the same time. A 2008 fax from the local narcotics task

force stated that K.D. had obtained controlled substances from five prescribers

and twelve pharmacies between December 2006 and December 2007. A 2005

police report in her file indicated that she and her husband had an altercation over

her ongoing drug abuse problem. She repeatedly sought replacement

prescriptions after claiming her medications were stolen. Dr. Hare noted several

points in K.D.’s file in which Dr. MacKay seemed to be concerned about K.D’s

behavior and wrote that he was going to place her on probation and limit her to

one prescriber and one pharmacy. But, Dr. Hare explained, whatever limitations

Dr. MacKay imposed were brief, and then K.D. would return to her old habits. In

Dr. Hare’s view, “the records indicate an ongoing problem of drug misuse,

abuse,” 
id., meaning that
Dr. MacKay should have addressed these issues more

appropriately. He concluded that “the evaluation . . . and the record don’t support

the long-term prescribing of controlled substances [to K.D.]” 
Id. Dr. MacKay
introduced testimony by a different medical expert, Dr. Perry

Fine, along with affidavits and testimony by patients and medical professionals

from the community in which he practiced, all in support of his continued

registration. Dr. MacKay’s numerous patients and colleagues relayed their

positive experiences with him, his well-regarded reputation in the community, and

their impressions that he provided excellent care to his patients. Several of Dr.

                                        -13-
MacKay’s patients testified that he had given them beneficial treatment for

legitimate pain problems.

      Dr. Fine reviewed some of Dr. MacKay’s patient files, including the

medical records of K.D. and M.R. Based on the files he reviewed, he testified

that the medical care given by Dr. MacKay to these patients was justified, and

that Dr. MacKay treated these patients in a professional medical environment. He

did not specifically discuss K.D. and M.R.’s patient files. Instead, he said his

general conclusion that Dr. MacKay’s treatment of his patients was medically

appropriate also applied to M.R. and K.D. When he was asked to discuss the

transcripts of M.R. and K.D.’s recorded appointments, Dr. Fine testified that he

was unable to “make sense out of” the transcripts. 
Id. at 49,966.
Without access

to a “full audiovisual recording” of the appointments, he said he could not draw

conclusions about what had transpired during those appointments. 
Id. Dr. MacKay
did not testify. 7



                                         II.

      On July 31, 2009, the ALJ issued his recommended decision, finding the

DEA presented sufficient evidence to establish that Dr. MacKay had “committed



      7
       Both sides presented other evidence which we do not recount here. For a
more thorough description of the evidence presented during the hearing, see
MacKay, 75 Fed. Reg. at 49,959-72.

                                        -14-
acts that are inconsistent with the public interest.” 
Id. at 49,958
(citing ALJ

Recommendation at 114). The described acts included exchanging prescription

drugs with K.D. for sexual favors, dispensing prescription drugs to patients

without first conducting appropriate diagnostic evaluations, providing

prescription drugs to K.D. despite being aware she was drug-dependent, and

maintaining inaccurate, incomplete, and misleading patient records – all in

violation of Utah law. The ALJ recommended that the Deputy Administrator

revoke Dr. MacKay’s registration and deny any pending application to renew it

because Dr. MacKay “‘ha[d] 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 [DEA] should continue to entrust him with a

registration.’” 
Id. (quoting ALJ
Recommendation at 114). Dr. MacKay filed

exceptions to the ALJ’s recommendation, contending it was based on insufficient

evidence.

      The Deputy Administrator adopted the ALJ’s recommendation. After

reviewing all of the evidence and Dr. MacKay’s objections, she agreed with the

ALJ that Dr. MacKay “has committed acts which render his continued registration

inconsistent with the public interest.” 
Id. She endorsed
the ALJ’s analysis and

found that evidence of Dr. MacKay’s conduct with respect to M.R. and K.D.

constituted a prima facie showing that his continued registration would be

inconsistent with the public interest. See 
id. at 49,977.
Even assuming Dr.

                                         -15-
MacKay complied with the law in treating all of his other patients, the Deputy

Administrator concluded that fact would not refute the evidence of intentional

diversion of controlled substances to K.D. and M.R. 
Id. Based on
Dr. MacKay’s

failure to testify, she concluded that he “does not accept responsibility for his

misconduct, and therefore, he has not rebutted the Government’s prima facie

showing that his continued registration is inconsistent with the public interest.”

Id. She held
that Dr. MacKay’s “egregious misconduct,” coupled with his failure

to acknowledge wrongdoing or show remorse, warranted revoking his registration

and denying any pending requests to renew or modify the registration. 
Id. at 49,978.
      Dr. MacKay asks us to reverse the Deputy Administrator’s decision and to

reinstate his registration. See 21 U.S.C. § 877.



                                         III.

      The Controlled Substances Act requires practitioners who dispense

controlled substances to obtain a valid registration. 21 U.S.C. § 822(a)(2). The

Deputy Administrator may revoke a practitioner’s registration if she determines

the practitioner “has committed such acts as would render his registration . . .

inconsistent with the public interest.” 
Id. § 824(a)(4);
see also 28 C.F.R.

§§ 0.100(b), 0.104. The agency is required to consider five factors “[i]n

determining the public interest”:

                                         -16-
      (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 public health and safety.

21 U.S.C. § 823(f). Although the Deputy Administrator must consider each of

these factors, she “need not make explicit findings as to each one and can ‘give

each factor the weight [she] determines is appropriate.’” Volkman v. DEA, 
567 F.3d 215
, 222 (6th Cir. 2009) (quoting 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) (similar).

      “Registrants dispensing controlled substances must comply with a number

of statutory and regulatory requirements.” 
Morall, 412 F.3d at 174
. As relevant

here, DEA regulations provide that a prescription is lawful only if “issued for a

legitimate medical purpose by an individual practitioner acting in the usual course

of his professional practice.” 21 C.F.R. § 1306.04(a). “The responsibility for the

proper prescribing and dispensing of controlled substances is upon the prescribing

practitioner . . . .” 
Id. Similarly, with
the exception of circumstances irrelevant

to this case, in Utah it constitutes “unprofessional conduct” for a physician to


                                         -17-
issue a prescription for a drug “without first obtaining information in the usual

course of professional practice, that is sufficient to establish a diagnosis, to

identify conditions, and to identify contraindications to the proposed treatment.”

Utah Code Ann. § 58-1-501(2)(m)(i). Not surprisingly, it is “unprofessional

conduct” for a licensed physician to “sexually abus[e] or exploit[] any person

through conduct connected with the licensee’s practice.” 
Id. § 58-1-501(2)(k).
Under Utah administrative rules, unprofessional conduct also includes:

      (4) failing to maintain controls over controlled substances which
      would be considered by a prudent practitioner to be effective against
      diversion, theft, or shortage of controlled substances;
      ...
      (6) knowingly prescribing, selling, giving away, or administering,
      directly or indirectly, or offering to prescribe, sell, furnish, give
      away, or administer any controlled substance to a drug dependent
      person, as defined in Subsection 58-37-2(s), except for legitimate
      medical purposes as permitted by law . . . .

Utah Admin. Code r. 156-37-502.

      The DEA has the ultimate burden of proving that revocation is warranted.

21 C.F.R. § 1301.44(e). Cognizant of this, the Deputy Administrator has

consistently held that once the government establishes a prima facie case showing

a practitioner has committed acts which render his registration inconsistent with

the public interest, the burden shifts to the practitioner to show why his continued

registration would be consistent with the public interest. See, e.g., Medicine

Shoppe-Jonesborough, 73 Fed. Reg. 364, 387 (DEA Jan. 2, 2008) (citing cases).

      If the Deputy Administrator’s findings of fact are supported by substantial

                                          -18-
evidence, they are conclusive. See 21 U.S.C. § 877. We have recognized that

substantial evidence is “more than a scintilla, but less than a preponderance.” Lax

v. Astrue, 
489 F.3d 1080
, 1084 (10th Cir. 2007). It “is such relevant evidence as

a reasonable mind might accept as adequate to support a conclusion.” 
Id. (internal quotation
marks omitted); see also Rapp v. Office of Thrift Supervision,

52 F.3d 1510
, 1516 (10th Cir. 1995).

      Under the Administrative Procedure Act, we may set aside the Deputy

Administrator’s decision only if it is “arbitrary, capricious, an abuse of discretion,

or otherwise not in accordance with law . . . [or] unsupported by substantial

evidence . . . .” 5 U.S.C. § 706(2). An agency decision is arbitrary and

capricious if the agency “relied on factors which Congress has not intended it to

consider, entirely failed to consider an important aspect of the problem, offered

an explanation for its decision that runs counter to the evidence before the

agency, or is so implausible that it could not be ascribed to a difference in view or

the product of agency expertise.” Motor Vehicle Mfrs. Ass’n of the U.S., Inc. v.

State Farm Mut. Auto. Ins. Co., 
463 U.S. 29
, 43 (1983).

      “The scope of our review under the ‘arbitrary or capricious’ standard is

narrow and we are not to substitute our judgment for that of the agency.” Colo.

Wild, Heartwood v. U.S. Forest Serv., 
435 F.3d 1204
, 1213 (10th Cir. 2006)

(citing Motor Vehicle Mfrs. 
Ass’n, 463 U.S. at 43
). To uphold the Deputy

Administrator’s decision under this standard, we must satisfy ourselves that she

                                         -19-
“examined the relevant data and articulated a satisfactory explanation for [her]

decision, including a rational connection between the facts and the decision

made.” See 
id. (citing Motor
Vehicle Mfrs. 
Ass’n, 463 U.S. at 43
). If we are so

convinced, her decision must stand.

                                          A.

      Dr. MacKay contends the Deputy Administrator’s decision is arbitrary and

capricious and not supported by substantial evidence. He argues the Deputy

Administrator failed properly to consider and weigh the five statutory

public-interest factors as required by 21 U.S.C § 823(f) and ignored evidence in

his favor. For these reasons, he submits, we must reverse the Deputy

Administrator’s revocation decision.

      In her discussion of the five statutory public interest factors, the Deputy

Administrator first examined factors one and three. She acknowledged that Dr.

MacKay held a valid medical license in Utah and that there was “no

‘recommendation’ one way or the other from the State Board as to whether [Dr.

MacKay] should retain his registration (factor one).” MacKay, 75 Fed. Reg. at

49,973. She also observed that Dr. MacKay “had not been convicted of an

offense related to controlled substances . . . (factor three).” 8 
Id. Nevertheless, as
      8
       After oral argument in this appeal, Dr. MacKay was found guilty of
committing forty violations of the Controlled Substances Act. These convictions
included illegally dispensing and distributing controlled substances to K.D. and
M.R. on the days of their recorded appointments. See Indictment at 10-11, United
                                                                         (continued...)

                                         -20-
she explained, “[A] State’s failure to take action against a registrant’s medical

license is not dispositive in determining whether the continuation of a registration

is in the public interest,” because the DEA has separate oversight responsibility

with respect to controlled substances. 
Id. (internal quotation
marks omitted).

Similarly, she noted that “while a history of criminal convictions for offenses

involving the distribution or dispensing of controlled substances is a highly

relevant consideration, . . . the absence of such a conviction is of considerably

less consequence in the public interest inquiry.” 
Id. Regarding factors
two and four, the Deputy Administrator found clear and

convincing evidence that Dr. MacKay knowingly diverted controlled substances

in violation of state and federal law through various acts including: giving

inadequate examinations to support prescriptions for controlled substances,

prescribing drugs to M.R. despite knowing she was not a legitimate pain patient,

prescribing drugs to K.D. despite obvious indications that she was overusing and

abusing drugs, and providing prescriptions for controlled substances to K.D. in

exchange for sexual favors. 
Id. at 49,973-77.
The Deputy Administrator found it

unnecessary to make findings under factor five in light of her findings under

      8
          (...continued)
States v. MacKay, 1:10-cr-00094 (D. Utah Aug. 5, 2010) (counts 4-7 and 11-14);
Jury Verdict at 2, MacKay, 1:10-cr-00094 (D. Utah Sept. 26, 2011). He was also
found guilty of illegally dispensing and distributing a controlled substance to
K.D. on September 23, 2006 – the day the Deputy Administrator found Dr.
MacKay met K.D. in the motel room. See Indictment at 10-11, MacKay, 1:10-cr-
00094 (count 8); Jury Verdict at 2, MacKay, 1:10-cr-00094.

                                         -21-
factors two and four. See 
id. at 49,977
n.38.

      Our review of the record persuades us that substantial evidence supports the

Deputy Administrator’s findings under factors two and four. As we have detailed

above, testimony and patient records reflect that Dr. MacKay failed to determine

a medical need for prescribing controlled substances to K.D. and M.R., either

initially or over the course of seeing these patients. K.D. and M.R. both testified

that their appointments with Dr. MacKay rarely involved either a physical

examination or a discussion of their pain. The recorded undercover appointments

confirm that Dr. MacKay discussed little – if anything – about M.R. or K.D.’s

medical conditions before issuing prescriptions for controlled substances to them.

Dr. MacKay even continued to prescribe controlled substances to M.R. after she

told him she had shared her drugs with a friend. The DEA’s expert, Dr. Hare,

testified that the medical records were totally inadequate to support the

prescriptions Dr. MacKay wrote for these patients.

      Similarly, substantial evidence supports the Deputy Administrator’s

determination that Dr. MacKay prescribed escalating amounts of controlled

substances to K.D. despite obvious indicators that she was misusing or abusing

the medication. According to documents in the medical file, she repeatedly

claimed she lost her drugs or that someone had stolen them. She requested refills

early. She received prescriptions from multiple doctors and pharmacies at the

same time, a fact known to Dr. MacKay. Substantial evidence also supports the

                                        -22-
Deputy Administrator’s determination that on multiple occasions while K.D. was

Dr. MacKay’s patient, Dr. MacKay engaged in sexual activities with her in

exchange for giving her prescriptions for controlled substances.

      Despite Dr. MacKay’s claim to the contrary, the Deputy Administrator

considered the entire record, including the evidence in Dr. MacKay’s favor. She

determined, however, that none of Dr. MacKay’s evidence negated the DEA’s

prima facie showing that Dr. MacKay had intentionally diverted drugs to K.D.

and M.R. 
Id. at 49,977.
Indeed, she found that even if Dr. MacKay had provided

proper medical care to all of his other patients, that fact would not overcome the

government’s evidence with regard to M.R. and K.D.

      None of the evidence presented by Dr. MacKay undermines the evidence

relating to M.R. and K.D. Although numerous patients and colleagues of Dr.

MacKay related their positive experiences with him, none had any personal

knowledge regarding his treatment of M.R. and K.D. Notably, Dr. MacKay’s

medical expert, Dr. Fine, failed to specifically discuss and justify Dr. MacKay’s

treatment of M.R. and K.D. As a result, none of Dr. MacKay’s evidence

contradicts the testimony and evidence presented by the DEA relating to the

knowing diversion of drugs to these two patients.

      Nor did the Deputy Administrator misweigh the five statutory factors for

determining the propriety of revocation, see 21 U.S.C. § 823(f). In light of Dr.

MacKay’s misconduct relating to factors two and four, the government made a

                                        -23-
prima facie showing that Dr. MacKay’s continued registration is inconsistent with

the public interest. See MacKay, 75 Fed. Reg. at 49,977. Although Dr. MacKay

may have engaged in the legitimate practice of pain medicine for many of his

patients, the conduct found by the Deputy Administrator with respect to K.D. and

M.R. is sufficient to support her determination that his continued registration is

inconsistent with the public interest. 9

                                           B.

      Dr. MacKay contends the Deputy Administrator violated the statutory

mandate by considering an additional factor not prescribed by statute: failure to

admit fault. Dr. MacKay argues that the Deputy Administrator should not have



      9
         Dr. MacKay raises several challenges to the ALJ and Deputy
Administrator’s credibility determinations. The Deputy Administrator deferred to
the ALJ’s findings that M.R. and K.D. were credible with regard to testimony of
their interactions with Dr. MacKay and his treatment of them. See MacKay, 75
Fed. Reg. at 49,964, 49,968 n.29. She also deferred to the ALJ’s judgment that
“Dr. Fine ‘intentionally avoid[ed] direct answers that did not favor the
Respondent’s position’” and that his testimony “was ‘evasive’ and ‘bias[ed] in
favor of assuming the correctness of the actions of any doctor.’” 
Id. at 49,963
(quoting ALJ Recommendation at 88, 90) (alterations in original). We are not
persuaded that these credibility findings were erroneous. “Credibility
determinations are peculiarly the province of the finder of fact, and we will not
upset such determinations when supported by substantial evidence.” Diaz v.
Sec’y of Health & Human Servs., 
898 F.2d 774
, 777 (10th Cir. 1990). Substantial
evidence supports the findings that K.D. and M.R. were credible. The recorded
appointments substantiated their testimony. The DEA also offered Dr. MacKay’s
motel receipt to corroborate K.D.’s claims that she engaged in sexual contact with
Dr. MacKay in a motel room. Finally, a review of Dr. Fine’s testimony supports
the Deputy Administrator’s determination that his testimony was evasive and
should be given less weight than the testimony of Dr. Hare.

                                           -24-
reached an adverse conclusion from his decision not to testify.

      Dr. MacKay’s argument lacks merit. The DEA may properly consider

whether a physician admits fault in determining if the physician’s registration

should be revoked. 
Hoxie, 419 F.3d at 483
. When faced with evidence that a

doctor has a history of distributing controlled substances unlawfully, it is

reasonable for the Deputy Administrator to consider whether that doctor will

change his or her behavior in the future. And that consideration is vital to

whether continued registration is in the public interest. Without Dr. MacKay’s

testimony, the Deputy Administrator had no evidence that Dr. MacKay recognized

the extent of his misconduct and was prepared to remedy his prescribing

practices.

      Nor was it improper for the Deputy Administrator to draw an adverse

inference from Dr. MacKay’s failure to testify. “[T]he Fifth Amendment does not

forbid adverse inferences against parties to civil actions when they refuse to

testify in response to probative evidence offered against them . . . .” Baxter v.

Palmigiano, 
425 U.S. 308
, 318 (1976). This rule applies with equal force to

administrative proceedings. See, e.g., 
Hoxie, 419 F.3d at 483
(holding DEA could

draw adverse inference from physician’s failure to testify during proceedings

involving revocation of his controlled substances registration); Keating v. Office

of Thrift Supervision, 
45 F.3d 322
, 326 (9th Cir. 1995) (“Not only is it

permissible to conduct a civil [administrative] proceeding at the same time as a

                                         -25-
related criminal proceeding, even if that necessitates invocation of the Fifth

Amendment privilege, but it is even permissible for the trier of fact to draw

adverse inferences from the invocation of the Fifth Amendment in a civil

[administrative] proceeding.”).

      Despite his claims to the contrary, Dr. MacKay did not lose “his livelihood

because he did not testify.” Reply Br. at 12. Instead, he lost his livelihood

because the DEA presented sufficient evidence that he distributed controlled

substances illegally and he failed to offer evidence that he would alter his conduct

in the future. Substantial evidence supports the Deputy Administrator’s

conclusion that Dr. MacKay’s continued registration is inconsistent with the

public interest.

                                         C.

      Dr. MacKay alternatively argues that it would have been more appropriate

under DEA precedent to restrict his DEA registration rather than revoke it

entirely. We disagree.

      Under the Administrative Procedure Act, 5 U.S.C. § 706(2)(A), the Deputy

Administrator’s choice of sanction “is entitled to substantial deference,” Chein v.

DEA, 
533 F.3d 828
, 835 (D.C. Cir. 2008), and we will set it aside only if her

decision is “arbitrary, capricious, an abuse of discretion, or otherwise not in

accordance with law.” 5 U.S.C. § 706(2)(A).

      Ordinarily, the mere unevenness in the application of a sanction will

                                        -26-
      not render its application in a particular case “unwarranted in law.”
      If the revocation represents a flagrant departure from DEA policy
      and practice, however, and if the departure is not only unexplained,
      but entirely unrecognized in the [Deputy Administrator’s] decision,
      the agency’s sanction cannot withstand abuse of discretion review.

Chein, 533 F.3d at 835
(quoting 
Morall, 412 F.3d at 183
) (internal quotation

marks, citations, and alterations omitted).

      Here, the sanction of revocation is neither a flagrant departure from DEA

policy and practice nor unexplained in the Deputy Administrator’s decision. The

Deputy Administrator has previously explained that “this Agency has long held

. . . that findings under a single factor [of 21 U.S.C. § 824(a)] are sufficient to

support the revocation of a registration.” Jayam Krishna-Iyer, M.D., 74 Fed. Reg.

459, 462 (DEA Jan. 6, 2006). In this same decision, the Deputy Administrator

noted that if “some isolated decisions of this Agency may suggest that a

practitioner who committed only a few acts of diversion was entitled to regain his

registration even without having to accept responsibility for his misconduct, the

great weight of the Agency’s decisions are to the contrary.” 
Id. at 464
(citation

omitted). Because the diversion of controlled substances poses a “grave and

increasing harm to public health and safety,” the Deputy Administrator made

clear that even where only a few acts of diversion have been committed, “this

Agency will not grant or continue the practitioner’s registration unless he accepts

responsibility for his misconduct.” 
Id. Accordingly, the
Deputy Administrator

overruled prior DEA decisions suggesting that a practitioner may regain his

                                          -27-
registration without accepting responsibility for his conduct. 
Id. at 464
n.9.

Because Dr. MacKay has not accepted responsibility for his conduct, revocation

of his registration is entirely consistent with DEA policy.

      Dr. MacKay relies on several DEA decisions in which physicians were

given restricted registrations in arguing that the revocation of his registration is

inconsistent with DEA precedent. We agree with the Deputy Administrator that

each of these decisions is distinguishable, see MacKay, 75 Fed. Reg. at

49,977-78, and none of them suggests the revocation of Dr. MacKay’s registration

was an abuse of discretion.

      Paul J. Caragine, Jr., 63 Fed. Reg. 51,592 (DEA Sept. 28, 1998), provides

the best support for Dr. MacKay’s argument, but does not undermine the Deputy

Administrator’s choice of sanction. The physician in Caragine engaged in many

actions similar to Dr. MacKay, including prescribing drugs in high quantities to

patients exhibiting drug-seeking behavior and maintaining incomplete or

inaccurate medical records. See 
id. at 51,594-98.
Unlike Dr. MacKay, however,

the physician in Caragine acknowledged that he should have recognized some of

his patients were addicted, admitted he should have treated some of his patients

differently, and voluntarily underwent training to help him better identify and

treat drug-seeking patients. 
Id. at 51,594-98,
51,601. More importantly, the

Deputy Administrator explained in proceedings below that in light of Krishna-

Iyer, 74 Fed. Reg. at 464 & n.9, if a case like Caragine were to arise today she

                                         -28-
“would likely deny the petitioner’s application.” MacKay, 75 Fed. Reg. at 49,978

n.39. Thus, the precedential value of Caragine is questionable in light of the

DEA’s worry that in recent years the “diversion of controlled substances has

become an increasingly grave threat to this nation’s public health and safety.”

Krishna-Iyer, 74 Fed. Reg. at 463.

      The physician in William P. Jerome, M.D., 61 Fed. Reg. 11,867, 11,867-68

(DEA Mar. 22, 1996), exchanged controlled substances for sexual favors, money,

and cocaine. Dr. Jerome voluntarily surrendered his registration when he pled

guilty to conspiracy to distribute controlled substances. 
Id. at 11,868.
Six years

later, after serving his prison term and undergoing rehabilitation, he was granted a

restricted registration to dispense controlled substances. 
Id. at 11,869-70.
Unlike

Dr. MacKay, however, Dr. Jerome admitted he had violated federal law and

“testified as to his remorse for his past misconduct and his determination that he

[would] not engage in such conduct in the future.” 
Id. at 11,870.
      Larry L. Kompus, M.D., 55 Fed. Reg. 30,990 (DEA July 30, 1990), is

similarly distinguishable. In that proceeding, the physician had been convicted of

crimes relating to exchanging controlled substances for sexual favors. But the

misconduct occurred more than ten years before the physician was granted a

restricted registration and the evidence showed no misconduct by the physician

after his release from prison. 
Id. at 30,992.
Moreover, the physician

“acknowledged the wrongfulness of his actions and [had] shown remorse for

                                       -29-
them.” 
Id. In Karen
A. Kruger, M.D., 69 Fed. Reg. 7016, 7018 (DEA Feb. 12, 2004),

the physician was diverting drugs to herself, admitted fault, and had undergone

treatment for her drug dependency. Furthermore, nearly five years had passed

without any evidence of misuse of controlled substances. 
Id. Finally, in
Wesley G. Harline, M.D., 65 Fed. Reg. 5665 (DEA Feb. 4,

2000), the physician admitted to having violated state law, 
id. at 5669,
showed

remorse, 
id. at 5671,
and testified that he was now complying with all state,

federal, and local laws, 
id. at 5669.
      Unlike the physicians in those cases, Dr. MacKay has never admitted any

fault or taken responsibility for his misconduct. Nor can he point to any evidence

that he reformed his habits. Instead, he continued to illegitimately dispense

controlled substances even when he knew the DEA was investigating him. The

Deputy Administrator’s revocation of Dr. MacKay’s registration is consistent

with the DEA’s policy and practice of revoking registration under such

circumstances.



                                        IV.

      For these reasons, we DENY Dr. MacKay’s petition for review.




                                        -30-

Source:  CourtListener

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