# Decision and Order: Clair L. Pettinger, M.D.

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/fr%3A2013-24052

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** October 3, 2013
- **Citation:** 78 FR 61592

## Text

DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 13-12]
Decision and Order: Clair L. Pettinger, M.D.

On June 5, 2013, Administrative Law Judge Christopher B. McNeil (hereinafter, ALJ) issued the attached Recommended Decision
1

(hereinafter, cited as R.D.).Therein, the ALJ found that the Government had proved that the Respondent issued nine prescriptions for controlled substances “that were not for a legitimate medical need and were not issued in the ordinary course of a professional medical practice,” as well as a prescription for hydrocodone after his DEA registration had been suspended, and that this evidence establishes that “the Respondent's continued [registration] is inconsistent with the public interest. R.D. at 57. The ALJ further found that the Government “has made a prima facie case in support of the proposed order revoking the Respondent's registration” and that “Respondent . . . failed to affirmatively acknowledge specific acts of improper prescribing of controlled substances and failed to establish by credible and substantial evidence effected steps taken in remediation.”
Id.
at 58. Accordingly, the ALJ found that “the Government has established cause to revoke the Respondent's DEA” registration,
id.,
and recommended that his registration be revoked and that any pending applications to renew or modify his registration be denied.
Id.
at 59.

1
All citations to the Recommended Decision are to the slip opinion as issued by the ALJ.

Both parties filed exceptions to the Recommended Decision. Thereafter, the record was forwarded to me for Final Agency Action.

Having considered the record in its entirety, including each party's exceptions, I have decided to adopt the ALJ's findings of fact and conclusions of law, except as discussed below. While I reject some aspects of the ALJ's discussion, I agree with the ALJ's legal conclusions that Respondent violated federal law in prescribing to each of the undercover officers, and that the Government has established a prima facie case to revoke Respondent's registration on the ground that he has committed acts which render his registration “inconsistent with the public interest.” 21 U.S.C. 824(a)(4). I further agree with the ALJ's conclusion that Respondent has failed to produce sufficient evidence to rebut the Government's
prima facie
case, as notwithstanding the unrefuted evidence that he knowingly and intentionally diverted drugs by issuing unlawful prescriptions, he failed to acknowledge his misconduct. A discussion of each party's exceptions follows.

Respondent's Exceptions

Respondent first takes exception to the ALJ's finding that he authorized a new prescription for 180 dosage units of Norco, a combination drug containing hydrocodone, a schedule III controlled substance, and acetaminophen, for his patient B.D., on December 21, 2012, ten days after he had been served with the Order to Show Cause and Immediate Suspension of Registration. Resp. Exceptions, at 1-4. In support of the allegation, the Government introduced several documents from the Safeway Pharmacy which filled the prescription. These included: (1) A copy of a prescription issued to B.D. by Respondent on October 22, 2012 for 180 dosage units of Norco, which authorized two refills; and (2) a printout from the pharmacy showing B.D.'s medical expenses between August 13 and December 21, 2012. GX 24, at 2, 4. Of note, the latter shows that the prescription, which was assigned the number 4362259, was filled on October 22, 2012, and refilled on November 12 and December 3, 2012.
Id.
at 4. Of further note, this document shows that on December 21, 2012, the pharmacy dispensed an additional 180 tablets of Norco to B.D., under a new prescription number and attributed the prescription to Respondent.
Id.

The Government also introduced into evidence a copy of a prescription refill request form, which was dated December 20, 2012, and which was faxed by the pharmacy to Respondent and then faxed backed to the pharmacy.
Id.
at 3; Tr. 91. Under the heading “PRESCRIPTION REQUEST,” the form indicated that the prescription was for B.D. and was 180 tablets of Norco; the form also stated that the prescription was “First Filled” on “Oct 22, 2012,” and “Last Filled” on “Dec 3, 2012.”
Id.
In the space for the doctor's signature, the form bore the following notation: “N Pettinger MD Can fill current refill No New Refill.”
Id.
On the upper right side of the form, were the words “MD and “OK x 1,” each of which was circled; in addition, an arrow was drawn from the latter to the words “No New Refill.”
Id.

At the hearing, the Special Agent, who was the Case Agent, testified that upon serving the Order to Show Cause and Immediate Suspension of Registration on Respondent, he told Respondent “that he was unable to dispense, prescribe or otherwise issue controlled substances from that point on” and that Respondent “stated to me that he understood that.” Tr. 87. The Case Agent further explained that while it was illegal for Respondent to authorize a new prescription after his registration was suspended, any refills that had been authorized prior to the suspension could be filled.
Id.
at 112.

In his testimony, the Case Agent explained that when the Refill Request fax was sent, “the patient had already refilled all the refills that were on the previous prescription”; the Agent also answered “no,” when asked if it would have been necessary to contact Respondent if there had been additional refills remaining on the prescription.
Id.
at 92. The Case Agent further testified that as far as he knew, pharmacists call a physician only to verify a new prescription and would not call to verify a refill.
Id.
at 112-13.

The Case Agent also testified (erroneously) that there was no information on the Refill Request form that showed that all of the previously authorized refills had been dispensed by the pharmacy.
Id.
at 115. Finally, the Case Agent testified that he could not state that Respondent had “knowingly” issued a new prescription in violation of the suspension order.
Id.
at 116.

Reviewing the Refill Request form, the ALJ concluded that the circled words “MD” and “No New Refill,” along with the arrow drawn to the words “No New Refill,” “indicat[e] that the pharmacist contacted [Respondent] and was told it was okay to dispense 180 generic Norco tablets, despite the fact that the pharmacy had already dispensed all of the medication authorized by the prescription written by [Respondent] on October 22, 2012.” R.D. at 9. The ALJ thus reasoned that “[w]hile this evidence does not establish that the pharmacist told [Respondent] that B.D. filled this prescription three times already, it does establish that [Respondent] knowingly authorized another 180 unit dispensation after being called by the pharmacist, a condition that would not have existed had there been a refill available under the original prescription.”
Id.
at 10.

Taking exception to this finding, Respondent asserts that “Exhibit 24 does not establish that Respondent was aware of the prior refills.” Resp. Exceptions, at 3. However, notwithstanding the testimony of the Case Agent and the ALJ's finding, the Refill Request form actually did contain evidence that the previously authorized refills had been dispensed. Specifically, the form indicates that the prescription had last been filled on December 3, 2012

and been filled in the full amount of 180 tablets. RX 24, at 3. Moreover, the bottom of the form includes the notations: “Remaining Qty: O” and “Rx Expires On: 04/23/2013.” RX 24, at 3. These, of course, are references to the previous prescription which had been issued on October 22, 2012, and which, in accordance with DEA regulations, was good for six months.
See
21 CFR 1306.22(a). Beyond this, as the ALJ pointed out, had there been any refills remaining on the original (October 22nd) prescription, the pharmacy would have had no reason to send the refill request form.

Respondent nonetheless asserts that his notation on the Refill Request Form used the word “refill” and not “prescription” and further states: “can fill current refill no new refill.” Resp. Exceptions, at 4. He argues that “[t]his contemporaneous handwritten note can only be interpreted as documenting Respondent's belief that he was confirming the “current” (i.e., existing) refill authorization and specifically declining to authorize a `new refill' (current prescription), just as instructed by” the Case Agent.
Id.

However, in his exceptions, Respondent entirely ignores that the Refill Request form also contains the circled notations of “MD” and “OK x 1,” along with the arrow that was drawn towards the words “No New Refill.” As noted above, based on these notations, the ALJ concluded that Respondent “knowingly authorized another 180 unit dispensation after being called by the pharmacist.” R.D. at 10.

The ALJ's conclusion that Respondent was called by the pharmacist and approved an additional dispensation of Norco is a permissible inference from the evidence.
2

While this may not be the only permissible inference which can be drawn from the notation, it nonetheless constitutes probative evidence of the allegation. Significantly, when called to testify, Respondent invoked his Fifth Amendment privilege. However, as the Supreme Court has explained, “the 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). As the Tenth Circuit has noted, “[t]his rule applies with equal force to administrative proceedings.”
MacKay
v.
DEA,
664 F.3d 808, 820 (10th Cir. 2011) (citing
Hoxie
v.
DEA,
419 F.3d 477, 483 (6th Cir. 2005)).
See also Keating
v.
Office of Thrift Supervision,
45 F.3d 322, 326 (9th Cir. 1995). Because Respondent refused to testify in response to the evidence suggesting that he had spoken with a pharmacist and authorized an additional dispensing (notwithstanding his having written “No New Refill” on the Refill Request form), I draw an adverse inference and conclude that he did authorize the December 21, 2012 dispensing, at which time his registration had been suspended. And because there was no reason for the pharmacy to contact him regarding a refill request unless there were no refills remaining, I conclude that Respondent knowingly authorized the dispensing in violation of the Immediate Suspension Order.

2
The Case Agent testified that the documents, which are identified as pages 2-4 of Government Exhibit 24, were obtained from the pharmacist at the Safeway Pharmacy and are “true and accurate cop[ies] of the documentation [he] obtained from the” pharmacy. Tr. 89.

Next, Respondent argues that the nine prescriptions which he issued to the undercover officers “cannot possibly be probative of whether [his] continued [r]egistration
is
inconsistent with the public interest.” Resp. Exceptions, at 5. According to Respondent, “[i]n addressing the public interest question, the key word is obviously the word `is[,]' not `was.' ”
Id.

Respondent thus maintains that because the undercover officers “never intended to consume the medication” and “were never at risk from this medication,” his issuance of the prescriptions is not probative of the public interest.
Id.
He further asserts that because he issued the prescriptions “over a year before the hearing,” his conduct in issuing them “cannot possibly be probative of whether [his] continued Registration [is] inconsistent with the public interest
unless
the Government shows either that this conduct “typif[ies] his conduct with actual patients who did consume the medications” or that his “prescribing practices did not improve to the point that he was in compliance with DEA requirements and the applicable standard of care.”
Id.
Respondent thus concludes by arguing that “[t]his analysis goes to the heart of the public interest question under 21 U.S.C. § [§ ] 823(f)(4) and 824,” and that “[a]ll of these provisions require an assessment of [his] current conduct and compliance.”
Id.
at 6.

As for his contention that “the key word is . . . `is' [and] not `was,' ” Respondent ignores, that in section 824(a), Congress granted the Agency authority to suspend or revoke a registration “upon a finding that the registrant . . .
has committed
such acts as would render his registration under section 823 of this title inconsistent with the public interest.” 21 U.S.C. 824(a)(4) (emphasis added). Thus, while a decision to continue or grant a new registration is prospective in nature, the Agency properly bases the public interest determination on instances of past misconduct, of which, here, there is no shortage.
3

As the Seventh Circuit has explained, and as the Agency has noted in numerous cases, “past performance is the best predictor of future performance.”
ALRA Labs, Inc.,
v.
DEA,
54 F.3d 450, 452 (7th Cir. 1995);
see also, e.g.,
Medicine Shoppe-Jonesborough,
73 FR 364, 387 (2008),
pet. for rev. denied, Medicine Shoppe-Jonesborough
v.
DEA,
300 Fed. Appx. 409 (6th Cir. 2008).

3
Notwithstanding that section 823(f) authorizes the Attorney General to “deny an application for [a practitioner's] registration . . . if the Attorney General determines that the issuance of such registration . . . would be inconsistent with the public interest,” here again, the provision explicitly recognizes the probative nature of an applicant's past conduct in making this determination as demonstrated by factor two, which directs the Attorney General to consider “[t]he applicant's experience in dispensing . . . controlled substances,” and factor three, which directs the Attorney General to consider “[t]he applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.” 21 U.S.C. 823(f)(2) & (3).

While the text of factor four, which directs the Attorney General to consider “[c]ompliance with applicable State, Federal or local laws relating to controlled substances” is not similarly limited to an applicant's past conduct, (nor limited to the specific applicant,
see David A. Ruben
78 FR 38363, 38385 n.47 (2013)), the Agency has long considered an applicant's record of compliance with laws related to controlled substances under this factor.
See Albert Lepis, M.D.,
51 FR 17555, 17555-56 (1986) (discussing physician's dispensings in violation of state law limiting quantity of controlled substances that could be prescribed under factor four (as well as factor two));
Carriage Apothecary, Inc.,
52 FR 27599, 27600 (1987).

As for Respondent's contention that the nine unlawful prescriptions are not probative of the public interest determination, because the undercover agents “never intended to consume the medication” and thus were “never at risk,” Resp. Exceptions at 5, the evidence clearly showed that Respondent intentionally and knowingly diverted controlled substances. Indeed, as catalogued by the ALJ, the Government's Expert testified to some twenty-two areas of concern regarding Respondent's prescribing practices.
See
R.D. at 30-32. These included his failure to resolve numerous red flags such as statements by the undercover officers that they were either diverting controlled substances or seeking them for recreational use; his falsification of medical records by indicating that he had performed an extensive physical exam when he had not; his failure to even examine the area of the body which was the source of an

undercover officer's purported pain; his—in the words of the Government's Expert—“[t]rolling for symptomology”; his suggesting to a patient that she claim to have pain radiating from her back into her leg to justify obtaining an MRI, as this was needed to justify his prescribing of oxycodone to her; and his typically rapid fire review with the patients of their medical history.
See id.
at 30-33. That each of the patients was an undercover agent does not make any of Respondent's acts of prescribing to them any less a violation of federal law. I thus reject Respondent's fatuous contention that his prescribing to the undercover officers is not probative of whether his registration is inconsistent with the public interest unless the Government can show that his conduct “can somehow be translated to typify his conduct with actual patients who did consume the medications.” Resp. Exceptions, at 5.

Respondent did allow that his prescribings to the undercover agents would be probative of the public interest determination if the Government could show that his “prescribing practice did not improve to the point that he was in compliance with DEA requirements and the applicable community standard of care.”
Id.
Here again, Respondent is confused, but not because the Agency's precedent is unclear. Under Agency precedent, DEA can revoke based on proof of a single act of intentional or knowing diversion.
See Dewey C. MacKay,
75 FR 49956, 49977 (2010);
see also Daniel Olefsky,
57 FR 928, 928-29 (1992). Moreover, where, as here, the Government makes out a
prima facie
case by showing that a registrant has committed acts which render his registration inconsistent with the public interest and which support the revocation of his registration, the registrant bears the burden of producing evidence to show that he accepts responsibility for his misconduct and has taken sufficient remedial measures to assure the Administrator that he will not engage in future misconduct.
MacKay,
75 FR at 49977. (collecting cases). Having established its
prima facie
case by showing that Respondent diverted controlled substances on multiple occasions, the Government was not required to show that his “prescribing practices [have] not improve[d] to the point that he [is] in compliance with DEA requirements and the applicable . . . standard of care.” Resp. Exceptions, at 5.

Next, Respondent argues that “[i]t is significant that the Government failed to introduce any evidence or testimony concerning Respondent's care of a single current patient, even a `drug seeking' one.”
Id.
at 6. He also asserts that “[t]he Government seized hundreds of medical charts” when it served the Immediate Suspension Order and yet “failed to introduce a single one of these charts, although presumably they were aware that Respondent had drug seeking patients in his practice.”
Id.

Because of the extent and egregious nature of his misconduct, Respondent's registration was Immediately Suspended simultaneously with the commencement of this proceeding. Thus, Respondent is without authority to lawfully dispense controlled substances to any current patient. Respondent does not explain why his care of a single current patient would be probative of his ability to responsibly and lawfully dispense controlled substances.

As for the Government's failure “to introduce a single one of” the patient charts it seized, the Government was not required to provide any such evidence to prove its case. Having conducted the nine undercover visits, the Government could reasonably conclude, based on its review of the evidence obtained during those visits, that Respondent was engaged in the diversion of controlled substances and that it had sufficient evidence to bring this proceeding.
See T.J. McNichol,
77 FR 57133, 57146 (2012) (rejecting ALJ's reasoning that the Government was required to review patients charts it had seized “to develop evidence that might enlighten the administrative record of [physician's] positive prescribing practices”; “[h]aving garnered evidence of what it believed to be unlawful prescriptions issued to . . . four undercover officers, the Government was entitled to go to hearing with that evidence”).

In a variation on a previous theme, Respondent further argues that his prescribing to the undercover officers “is useless in determining the public interest question” because “all” of the agents engaged in “diverting behavior” by “discussing extraneous matters” with him. Resp. Exceptions, at 7. Respondent asserts that this behavior is atypical of drug seeking patients and that “it tended to divert [his] attention from the symptoms he was asking about so that the recording would contain less evidence of a legitimate examination and history taking” and also diverted his “attention from his note taking which distorted the medical record itself.”
Id.

However, as explained above, Respondent did not testify, and thus, there is no evidence to support his assertion that the putatively extraneous conversations diverted his attention from his responsibilities in either questioning his patients regarding their conditions and medical history or his note taking. Moreover, as the ALJ found (
see
R.D. at 15), while the Agents may have initiated the extraneous conversations, such as when Agent Breeden noted that Respondent had gone to Nebraska and that “they play Penn State . . . this week,” Respondent perpetuated the conversation by noting “that Joe Paterno thing is so stupid,” that “these politically correct people just piss me off to no end” and continuing to discuss the Penn State/Jerry Sandusky scandal for several minutes thereafter.
4

See
GX 5, at 8-12. Furthermore, the extraneous conversation had long ended by the time Agent Breeden and Respondent proceeded to discuss what drugs the former (in his undercover capacity) was using and why he was using them, and during which the following exchange occurred:

4
Respondent asserts that the ALJ's Recommended Decision “recognized [that]
all
Agents engaged in this diverting behavior,” by trying to distract him during his evaluation of the patients. Resp. Exceptions, at 7. However, following a review of the recordings, I agree with the ALJ's finding:

That the conversations engaged in by these agents were [not] designed to divert [Respondent's] attention or keep him from performing a proper, adequate, physical examination. To the contrary, most of the extraneous dialogue recorded here was occasioned by Respondent himself. The record does, however, make clear that each of the undercover agents tried to act like drug-seeking patients. . . .

R.D. at 15.

Dr: So you use the norcos and?

Agent: Uh yes I use pretty much whatever I (unintelligible) whatever I have available.

Dr: Ok the opanas are so damned expensive do you notice any high out of the opanas at all they make you dopy for (unintelligible)?

Agent: (unintelligible) well compare to the old the old oxy's um . . . you know I got some friends who've used the um who don't like ‘em um I personally I like ‘em I mean I (unintelligible).

Dr: which ones?

Agent: the opanas . . . but they're harder to get for than the . . . roxicodones are . . . and they're way more expensive though.

Dr: yea.

Agent: the opanas are . . . ya know twice as much as the Roxicodone are.

Dr: and then you you get the norcos as well?

Agent: some sometimes mostly the Roxicodone and the opanas.

GX 5, at 27-28.

Moreover, a further review of the transcript and recording shows that Respondent was not distracted when he informed the Agent that “for pain medication I would charge you $200 dollars . . . and then I charge you $80 dollars a month for your prescriptions,”

but that he was “gonna do [the Agent] better than that because . . . I'm gonna give you the cannabis card” for which, “when I do the pain medication prescriptions with the cannabis then you know I charge $180 for the cannabis recommendation,” but that “on the initial evaluation I charge people half on their prescriptions so instead of charging you $80 bucks I charge you $40.” GX 5, at 38. Nor was Respondent distracted by the Agent when the latter explained that he had $200 on him and Respondent agreed that “for $200 we'll just go ahead and do your prescriptions for your norcos and your and stuff” and “do the [cannabis] card for you too.”
Id.

Later, after a discussion of various cannabis related issues, Respondent and the Agent proceeded to discuss what prescriptions the latter wanted, with the following exchange occurring:

Dr: . . . what are we gonna do as far as prescriptions for what are you using you say you are using norcos?

Agent: ah mostly the uh opana or the uh roxies um and then if uh I'm not sure if it'd be the same prescription or not (unintelligible) the cough syrup too.

Dr: ok so basically you want to end up getting the oxycodone you want the IR's the 30 IR's?

Agent: Ah, yea.

Dr: ok and how many of those . . . are you taking?

Agent: what is it (unintelligible) for a month what is it 120?

Dr: Ok.

Id.
at 41-42. Here again, Respondent was not distracted. Nor was he distracted when the Agent also asked for the cough syrup, and Respondent replied: “I'll give you the promethazine.”
Id.
at

42.
5

5
It is noted that Respondent did ask the Agent various questions regarding his medical history. However, he did not ask any questions about the Agent's purported pain level and how it affected his ability to function.
See
Tr. 343 (testimony of Government's Expert: “he's a tile man, and nowhere in the information that I listened to or read was there any conversation about how his pain conditions [sic] was interfering with his ability to be a tile man. It seems to me it would be very hard to be a tile man if you had knee pain or back pain.”);
id.
at 344-45 (testimony of Government's Expert; “nor did I get any impression from the transcript or the recording of the degree of pain that was being suffered on a scale of one to [ten], or even using such words as mild, moderate or severe. None of that language was employed”);
id.
at 325-26 (Expert's testimony discussing scope of questioning by a physician in assessing a patient's pain complaint).

Nor does Respondent explain why these distractions prevented him from examining the Agent's knee, which was the purported area of the Agent's pain.
See
Tr. 133 (Agent's testimony that Respondent did not at any point look at his knee);
see id.
at 345-46 (testimony of Government's Expert: Noting that upon review of Agent Breeden's medical record, there was “a very nondetailed examination of the musculoskeletal system, although that was quite relevant to the pain complaint, the pain complaint being knee pain. One would customarily expect to see a highly detailed knee examination and an examination of the joints on either side of the knee, that being the ankle and the hip”).

I also reject Respondent's contention that the Government's Expert's testimony should be “given very little weight” because she “had never qualified as an expert witness” by testifying in a medical board case on “the “treatment of non-cancer pain.” Resp. Exceptions, at 8. There is, of course, a first time for everything, and the Expert testified that she has reviewed other cases for the state medical board which involved the long-term use of opiates in managing chronic, non-cancer pain. Tr. 320. In addition, the Expert testified that she has been a clinical professor of medicine at the U.C. Davis School of Medicine for nearly thirty years; she also testified that in her prior position, she had evaluated one to five patients each week to determine whether to initiate long term opioid therapy for non-cancer pain and had prescribed oxycodone for one to two patients a week.
Id.
at 322-23.

Finally, Respondent argues that the ALJ failed to give proper weight to his evidence of remediation. Resp. Exceptions, at 8-9. First, he argues that the ALJ failed to recognize that he expressed remorse when he admitted to the Case Agent “that he had been over prescribing in the past.”
Id.
at 8. Second, he argues that while the ALJ acknowledged “the testimony of two patients (of Respondent) who received appropriate examinations and treatment,” the ALJ “made no finding impugning the veracity of [the clinic employee who testified] about improvements in the practice with respect to controlled substance prescribing.”
Id.
at 8-9.

As for the testimony of Respondent's patients that they received appropriate examinations and treatment and were helped by his treatment, neither patient testified that they possess medical expertise. Moreover, because under the CSA, “registration is limited 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 [his] professional career.”
Jayam Krishna-Iyer,
74 FR 459, 463 (2009). Thus, while Respondent may have treated these two legitimate patients appropriately, this says nothing about his management of persons who seek controlled substances to either abuse or divert them.
See MacKay
v.
DEA,
664 F.3d at 819 (“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.”).

It is acknowledged that the Practice Manager at the urgent care clinic, where Respondent is now employed, testified regarding the new procedures he instituted to screen out non-complying patients. However, to rebut the Government's
prima facie
case, Respondent was required to produce evidence not only as to his corrective measures, he was also required to acknowledge his misconduct in prescribing to the undercover officers.
Medicine Shoppe-Jonesborough,
73 FR at 387 (quoting
Samuel S. Jackson,
72 FR 23848, 23853 (2007));
John H. Kennedy,
71 FR 35705, 35709 (2006). As the Tenth Circuit has explained:

. . . The DEA may properly consider whether a physician admits fault in determining if the physician's registration should be revoked. When faced with evidence that a doctor has a history of distributing controlled substances unlawfully, it is reasonable for the . . . 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. McKay recognized the extent of his misconduct and was prepared to remedy his prescribing practices.

MacKay,
664 F.3d at 820 (citing
Hoxie
v.
DEA,
419 F.3d 477, 483 (2005)).

Here, the only evidence regarding whether Respondent admits fault with respect to anything, was his admission during an interview (on the date the ISO was served) with the Case Agent “that some of his patients were not legitimate” and that “a number of them were receiving too many pills.” Tr. 104. Indeed, as noted above, at the hearing, Respondent invoked his Fifth Amendment privilege. Thus, Respondent has entirely failed to address the multiple acts of intentional diversion which he committed when he prescribed to the undercover officers. Respondent has therefore failed to produce sufficient evidence to rebut the conclusion that his continued registration would be consistent with the public interest.
See MacKay,
664 F.3d at 820;
Medicine Shoppe-Jonesborough,
73 FR at 387.

The Government's Exceptions

While the Government apparently agrees with the ALJ's ultimate conclusion of law and recommended order (
i.e.,
that Respondent's registration is inconsistent with the public interest and should be revoked), it takes exception to two features of his recommended decision. First, it takes

exception to the ALJ's conclusion that even in a proceeding brought pursuant to section 824(a)(4), it must identify in the Show Cause Order each of the public interest factors it is relying on. Govt. Exceptions, at 1-4. Second, it takes exception to the ALJ's legal conclusion that factor two (the experience factor) should not be considered “[w]here evidence of the Respondent's experience, as expressed through his patients and employees, is silent with respect to the quantitative volume of the Respondent's experience,” R.D. at 56, thus impliedly suggesting that the Government has an obligation to put forward evidence as to the volume of a registrant's prescribing activities in order to rely on this factor. Gov. Exceptions, at 4-9. Both of the Government's exceptions are well taken.

As for his conclusion that the Government cannot rely on factor two because it did not cite the factor in either the Show Cause Order or its Pre-Hearing Statements, the ALJ cites no authority for this hyper-technical view of the Agency's notice obligation. Contrary to the ALJ's understanding, that the Government did not refer to factor two until its opening statement violated neither federal law nor the Due Process Clause.

Here, the Government set forth that it was proposing the revocation of Respondent's registration “pursuant to 21 U.S.C. 824(a)(4) . . . because [his] continued registration is inconsistent with the public interest, as that term is defined in 21 U.S.C. 823(f).” ALJ Ex, 1, at 1. In addition, the Government set forth specific factual allegations regarding each of the nine undercover visits which it alleged resulted in Respondent issuing prescriptions “outside the usual course of professional practice or for other than a legitimate medical purpose.”
Id.
at 2-3. The Government further alleged that Respondent violated 21 U.S.C. 841(a)(1), which makes it unlawful to intentionally or knowingly distribute a controlled substance except as authorized by the Controlled Substances Act, as well as 21 CFR 1306.04(a), which requires that a controlled substance prescription “be issued for a legitimate medical purpose by [a] practitioner acting in the usual course of his professional practice.”

“ `Pleadings in administrative proceedings are not judged by the standards applied to an indictment at common law.' ”
Aloha Airlines
v.
Civil Aeronautics Bd.,
598 F.2d 250, 262 (D.C. Cir. 1979) (quoted in
CBS Wholesale Distributors,
74 FR 36746, 36749 (2009));
accord Citizens State Bank of Marshfield
v.
FDIC,
751 F.2d 209, 213 (8th Cir. 1984). Thus, “the failure of the Government to disclose an allegation in the Order to Show Cause is not dispositive and an issue can be litigated if the Government otherwise timely notifies a [r]espondent of its intent to litigate the issue.”
CBS Wholesale,
74 FR at 36570. And while the Agency has held that “the parameters of the hearing are determined by the prehearing statements,” consistent with numerous court decisions, it has also recognized that even where an allegation was not raised in either the Show Cause Order or pre-hearing statements, the parties may nonetheless litigate an issue by consent.
Pergament United Sales, Inc.,
v.
NLRB,
920 F.2d 130, 135-37 (2d Cir. 1990);
see also Duane
v.
Department of Defense,
275 F.3d 988, 995 (10th Cir. 2002) (discussing
Facet Enterprises, Inc.,
v.
NLRB,
907 F.2d 963, 974 (10th Cir. 1990); “we held that defendant had constructive notice of an alternate theory of liability not described in the formal charge when the agency detailed that theory during its opening argument and at other points during the hearing and when the defendant's conduct revealed that it understood and attempted to defend against that theory”);
Grider Drug #1 & Grider Drug #2,
77 FR 44070, 44077 (2012) n.23 (holding that notwithstanding that the Government did not provide adequate notice of its intent to litigate an allegation in either the Show Case Order or its pre-hearing statements, where respondents “did not object that the allegation was beyond the scope of the proceeding and that they were denied adequate notice of it” and “fully litigated the issue,” the allegation was litigated by consent) (citing
Citizens State Bank,
751 F.2d at 213;
Kuhn
v.
Civil Aeronautics Bd.,
183 F.2d 839, 841-42 (D.C. Cir. 1950); and
Yellow Freight System, Inc.,
v.
Martin,
954 F.2d 353, 358 (6th Cir. 1992)).

“The primary function of notice is to afford [a] respondent an opportunity to prepare a defense by investigating the basis of the complaint and fashioning an explanation that refutes the charge of unlawful behavior.”
Pergament United Sales,
920 F.2d at 135 (citation omitted). The Government adequately fulfilled this function when it disclosed the legal authority for the Agency's proposed revocation of Respondent's registration,
see
ALJ Ex. 1, at 1 (citing 21 U.S.C. 824(a)(4), 823(f)); the factual allegations that Respondent had issued prescriptions for oxycodone to undercover agents on nine different occasions,
see id.
at 2-3; and the legal basis for its contention that the prescriptions were unlawful.
See id.
at 2 (alleging that Respondent “issued these prescriptions outside the usual course of professional practice or for other than a legitimate medical purpose, in violation of 21 U.S.C. 823(f)(4),
6

841(a)(1), and 21 CFR 1306.04(a)”).

6
While the Government alleged that Respondent's prescribings to the undercover agents violated section 823(f)(4), this provision cannot be violated because it does not create a substantive rule of conduct. Rather, it is simply a factor which Congress directed the Agency to consider in making the public interest determination under section 823(f).
Cf. Bio Diagnostic International,
78 FR 39327, 39330 (2013) (quoting
Penick Corp., Inc.
v.
DEA,
491 F.3d 483, 490 (D.C. Cir. 2007) (other citations omitted) (“the `enumerated factors represent components of the public interest rather than independent requirements for registration' ”)).

That the Government did not specifically reference it was seeking an analysis of this evidence under factor two (as well as factor four) until its opening statement did not in any way prejudice Respondent.
7

Respondent neither objected to the Government's argument, nor argued in its post-hearing brief that he was prejudiced by the Government's assertion that his various violations “are grounds for revocation of [his] registration based on” both factors two and factor four. Tr. 70. Indeed, in a section of his post-hearing brief entitled “undisputed matters,” Respondent noted that “[t]he Government, in its opening statement set forth its intention to prove, in its case and [sic] chief, that Respondent's DEA registration should be revoked based on the public interest factors set forth in 21 U.S.C. 823(f) factors 2 and 4 only.” Resp. Post-Hrng. Br. 4 (citing Tr. 69-70). Thus, even if the public interest factors created substantive rules of conduct, which they do not, this case stands four square with
Facet Enterprises.
See 907 F.2d at 972.

7
See Tr. 70 (“These violations of the Controlled Substances Act and DEA regulations are grounds for revocation of the Respondent's DEA registration based on the public interest pursuant to 21 U.S.C. 824(a)(4) as determined by 21 U.S.C. 823(f), Factor 2, the registrant's experience at dispensing controlled substances, and Factor 4, compliance with applicable state, federal or local laws relating to controlled substances.”).

Even if Respondent had claimed prejudice, I would not find the argument persuasive. This is so because whether the Government's evidence regarding the prescriptions was considered under factor two (the experience factor), factor four (the compliance factor), or both factors together, Respondent knew “ `what conduct was being alleged and ha[d] a fair opportunity to present [his] defense.' ”
Duane
v.
Department of Defense,
275 F.3d at 995 (quoting
Facet Enterprises.,
907 F.2d at 972). The allegations that Respondent violated the CSA's prescription requirement and

unlawfully distributed controlled substances to the undercover agents, as well as the potential defenses to the allegations, are the same whether the conduct is considered under factor two or factor four. Accordingly, while I agree with the ALJ's conclusion that Respondent waived any objection to the Agency's consideration of the prescription evidence under factor two, I reject the ALJ's conclusion that the Government did not provide adequate notice of “its intention to rely on Factor Two in this hearing.” R.D. at 46.

The Government also took exception to the ALJ's legal conclusion that factor two “should not be used to determine whether Respondent's continued registration is inconsistent with the public interest.” Gov. Exceptions, at 4-9. In support of this conclusion, the ALJ offered the following reasoning:

In order to establish a basis for revoking a Certificate of Registration based on the provisions of 21 U.S.C. § 823(f)(2) (Factor Two), and assuming Factor Two applies to both applicants and registrants, the Government must present evidence establishing, by at least a preponderance, that the experience of the Respondent in dispensing controlled substances is of such character and quality that his continued registration is inconsistent with the public interest. This requires evidence of both the qualitative and quantitative volume of the Respondent's experience. Where evidence of the Respondent's experience, as expressed through his patients and employees, is silent with respect to the quantitative volume of the Respondent's experience, and requires speculation to support an adverse finding under Factor Two, this Factor should not be used to determine whether the Respondent's continued registration is inconsistent with the public interest.

R.D. at 56. I reject the ALJ's analysis as it entirely ignores relevant precedent and is illogical.

Earlier in his Recommended Decision, the ALJ explained that “in analyzing a registrant's experience under Factor Two [that] the Administrator should consider the context of a registrant's entire dispensing practices, notwithstanding that isolated acts against the public interest can outweigh substantial positive experience.” R.D. at 43. As support for this reasoning, the ALJ cited four cases: The Eleventh Circuit's unpublished decision in
Jayam Krishna-Iyer;
as well as the Agency's decisions in
Jeffery J. Becker,
77 FR 72387 (2012);
T.J. McNichol,
77 FR 57133 (2012); and
Rene Casanova,
77 FR 58150 (2012). Notably, the ALJ did not discuss either the Agency's decision on remand in
Krishna-Iyer,
74 FR 459 (2009), or its decision in
Dewey C. MacKay,
75 FR 49956 (2010). Nor did the ALJ discuss the Tenth Circuit's decision in
MacKay. See MacKay
v.
DEA,
664 F.3d 808 (10th Cir. 2011).

On remand in
Krishna-Iyer,
I discussed at length the role of so-called “positive experience” evidence in Agency proceedings where, as here, the Government has proved that a registrant has committed intentional diversion. Therein, in response to the court's instruction that I re-consider my findings under the experience factor, giving “particular attention to the entire corpus of [the physician's] record in dispensing controlled substances [notwithstanding that there was no such evidence in the record], not only the experience [with the] undercover officer[s],” I assumed, without deciding, that the physician's “prescribings of controlled substances to every other person she has treated constitute `positive experience.' ” 74 FR at 462-63. However, I explained that the physician's “prescribings to thousands of other patients do 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 (21 U.S.C. 823(f)).

Moreover, I then explained that under the CSA, only those persons who are authorized to dispense controlled substances under the laws of the State in which they practice are entitled to be registered.
Id.
Continuing, I explained that “[b]ecause under law, registration is limited 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.

I then discussed several cases in which the practitioners had argued that the Agency should ignore their acts of intentional or reckless diversion because they had dispensed controlled substances to thousands of patients legitimately.
Id.
(discussing
Paul J. Caragine, Jr.,
63 FR 51592, 51599-600 (1998);
Medicine Shoppe-Jonesborough,
73 FR at 386 & n.56). For example, in
Caragine,
the Agency noted in its discussion of factor two that the physician had practiced medicine for 20 years and had “seen over 15,000 patients.” 63 FR at 51599. While the Agency did not dispute this, it explained that what was “[a]t issue in this proceeding is Respondent's controlled substance prescribing to 18 patients.”
Id.
After a lengthy discussion of the physician's prescribing practices with respect to the patients (some of which rejected the ALJ's findings of improper prescribing), which was conducted under the auspices of factor two,
see id.
at 51599-600, the Agency explained “that even though the patients at issue are only a small portion of Respondent's patient populations, his prescribing of controlled substances to these individuals raises serious concerns regarding [his] ability to responsibly handle controlled substances in the future.”
Id.
at 51600.
8

8
Moreover, in contrast to this case, the Agency acknowledged that the patients at issue all “had legitimate medical problems that warranted some form of treatment.” 63 FR at 51601. It should also be noted there was no evidence that the physician had knowingly or intentionally diverted controlled substances and the physician put on evidence of his rehabilitation.

More recently, in
Medicine Shoppe-Jonesborough,
I concluded that notwithstanding the pharmacy's argument that it had 17,000 patients, the evidence that it had diverted controlled substances to twelve patients established that its “experience in dispensing controlled substances warrants a finding that its continued registration is inconsistent with the public interest.” 73 FR at 386. Noting that “[t]he fundamental question under the CSA is whether Respondent `has committed such acts as would render [its] registration inconsistent with the public interest,' ” I concluded that “[n]o amount of legitimate dispensings can render Respondent's flagrant violations [acts which are] `consistent with the public interest.' ”
Id.
n. 56.

In
Krishna-Iyer,
I also noted that DEA had revoked a practitioner's registration based on a physician's presentation, at the same time, of two fraudulent prescriptions to a pharmacy, noting that the physician had “ `refuse[d] to accept responsibility for his actions and does not even acknowledge the criminality of his behavior.' ”
Id.
at 463 (discussing and quoting
Alan H. Olefsky,
57 FR 928, 928-29 (1992)). I therefore held that “evidence that a practitioner has treated thousands of patients does not negate a
prima facie
showing that the practitioner has committed acts inconsistent with the public interest.”
Id.
And I further explained that “[w]hile such evidence may be of 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.

Thus, in
Krishna-Iyer,
I adhered to my previous conclusion that the “Respondent's dispensings to the undercover officers and her pre-signing of prescriptions and unlawful delegation of her prescribing authority

to her nurse, establish a
prima facie
case that her continued registration is `inconsistent with the public interest.' ”
Id.
(quoting 21 U.S.C. 824(a)(4)). I also made clear that had Respondent not acknowledged her misconduct, I would have revoked her registration again.

Subsequently, in
MacKay,
I found that the evidence that the physician had intentionally diverted controlled substances to two patients and did so on multiple occasions was “sufficient to hold that the government had made a
prima facie
showing that [the physician] had committed acts which render his registration inconsistent with the public interest.” 75 FR at 49977. Citing the Eleventh Circuit's unpublished decision in
Krishna-Iyer,
the physician argued that “ `[a] better assessment of [his] medical practice and habits can be ascertained from [his] numerous positive experiences in prescribing controlled substances, some of which were recounted by the patients themselves . . . at the hearing.' ”
Id.
(quoting Resp. Summation Br. at 3).

Based on my decision on remand in
Krishna-Iyer,
I rejected Respondent's argument.
See id.
As I explained: “even assuming, without deciding, that Respondent's prescribing practices to all of his other patients (including those whose medical records were reviewed by the Government's expert) fully complied with the CSA and Utah law, these prescribings do not refute the evidence showing that he intentionally diverted to [the two patients] in violation of both the CSA and Utah law.”
Id.
I therefore rejected the physician's “arguments and conclude[d] that the Government ha[d] established a
prima facie
case that his continued registration is `inconsistent with the public interest.' ”
Id.
(citing 21 U.S.C. 823(f)).
9

9
The physician also put on the testimony of three fellow physicians and introduced affidavits from sixteen other physicians. 75 FR at 49977. I placed no weight on this evidence because none of the physicians had personal knowledge of the physician's prescribing with respect to the two patients.
Id.
at n.37.

On review of the Agency's decision, the Tenth Circuit held “that substantial evidence supports the [Agency's] findings under factors two and four” that the physician had “knowingly diverted controlled substances in violation of state and federal law.”
MacKay
v.
DEA,
664 F.3d at 818. Addressing the physician's contention that the Agency had failed to consider his “positive experience” evidence, the Tenth Circuit explained:

None of the evidence presented by Dr. MacKay undermines the evidence relating to [the two patients]. Although numerous patients and colleagues of Dr. MacKay related their positive experiences with him, none had any personal knowledge regarding his treatment of [them]. Notably, Dr. MacKay's medical expert . . . failed to specifically discuss and justify Dr. MacKay's treatment of [the two patients]. 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 prima facie showing that Dr. MacKay's continued registration is inconsistent with the public interest.
See MacKay,
75 FR 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 [the two patients] is sufficient to support her determination that his continued registration is inconsistent with the public interest.

Id.
at 819. The Tenth Circuit thus denied the physician's petition for review.

As noted above, in his discussion of the experience factor, the ALJ entirely failed to discuss the Agency's decision on remand in
Krishna-Iyer,
as well both the Agency's and Tenth Circuit's decision in
MacKay.
However, as these precedents make clear, allegations that a practitioner has violated the prescription requirement (21 CFR 1306.04(a)) are properly considered—for obvious reason—under the experience factor. Moreover, while the respondent- practitioner in a proceeding brought under sections 823(f) and 824(a)(4) may put on evidence as to his experience as a compliant registrant, the Government has no obligation to put forward such evidence.

Thus, as the Tenth Circuit's decision in
MacKay
demonstrates, where the Government proves that a registrant has violated the prescription requirement, its evidence is still sufficient to make out a
prima facie
case under 21 U.S.C. 824(a)(4) even where the registrant has produced evidence of his experience as a compliant registrant. That being the case, it is absolutely clear that, where, as here, the Government has proved that a registrant has violated the prescription requirement, the Government is entitled to a finding that the evidence with respect to the registrant's experience in dispensing controlled substances establishes that he “has committed such acts as would render his registration . . . inconsistent with the public interest.” 21 U.S.C. 824(a)(4);
MacKay,
664 F.3d at 819.

This is so, even where there is no evidence “with respect to [the practitioner's] overall practice history,” and “we do not know the number of patients he has served.” R.D. at 45.
10

Indeed, notwithstanding various cases which have discussed the volume of a practitioner's dispensing activity as a relevant consideration under the experience factor, no case has ever placed the burden of producing evidence as to the volume of a practitioner's legitimate dispensings on the Agency. This is for good reason, as one of the fundamental principles of the law of evidence is that the burden of production on an issue is typically allocated to the party which is “most likely to have access to the proof.” Christopher B. Mueller & Laird C. Kirkpatrick, 1
Federal Evidence
§ 3:3, at 432 (3d ed. 2007).
11

10
The ALJ further explained that “we do not know . . . the value of [the Respondent's] service to the community, or other similar demographic factors relevant to the issue.” R.D. 45. Contrary to the ALJ's understanding, there is no need to know any of this, because the Agency has held that so-called “community impact” evidence is irrelevant to the public interest determination.
See Linda Sue Cheek,
76 FR 66972, 66972-73 (2011);
Gregory D. Owens,
74 FR 36571, 36757 (2009).

11
Nor is the Agency required to calculate a ratio of a practitioner's lawful to unlawful dispensings.

I therefore reject the ALJ's conclusion of law that “[w]here evidence of the Respondent's experience, as expressed through his patients and employees, is silent with respect to the quantitative volume of the Respondent's experience, . . . this Factor should not be used to determine whether the Respondent's continued registration is inconsistent with the public interest.” R.D. at 56. Consistent with Agency precedent which has long considered violations of the CSA's prescription requirement under factor two (as well as factor four), I hold that the evidence relevant to factor two establishes that Respondent violated 21 CFR 1306.04(a) when he dispensed controlled substances to the various undercover officers, and that this establishes a
prima facie
case that he has committed acts which “render his registration inconsistent with the public interest.” 21 U.S.C. 824(a)(4).
See also Carriage Apothecary,
52 FR 27599, 27600 (1987) (holding that evidence that pharmacy failed to maintain proper records and could not account for significant quantities of controlled substances was relevant under both factors two and four);
Eugene H. Tapia,
52 FR 30458, 30459 (1987) (considering evidence that physician did not perform physical exams and issued medically unnecessary prescriptions under factor two; no evidence regarding quantity of physician's legitimate dispensings);
Thomas Parker Elliott,
52 FR 36312, 36313 (1987) (adopting ALJ's conclusion

that physician's “experience in the handling [of] controlled substances clearly warrants finding that his continued registration is inconsistent with the public interest,” based on physician's having “prescribed enormous quantities of highly addictive drugs to [ten] individuals” without adequate medical justification);
Fairbanks T. Chua,
51 FR 41676, 41676-77 (1986) (revoking registration under section 824(a)(4) and citing factor two, based, in part, on findings that physician wrote prescriptions which lacked a legitimate medical purpose; physician's “improper prescribing habits clearly constitute grounds for the revocation of his . . . [r]egistration and the denial of any pending applications for renewal”).

In his discussion of factor two, the ALJ also explained that:

[o]n its face, Factor Two does not appear to be directly related to registrants like Dr. Pettinger. By its express terms, Factor Two applies to applicants, and calls for an inquiry into the applicant's “experience in dispensing, or conducting research with respect to controlled substances.” Thus, it is not clear that the inquiry into Dr. Pettinger's experience in dispensing controlled substances is warranted, given the limited scope of this factor.

R.D. at 42. The ALJ nonetheless “assum[ed] [that] Factor Two does indeed pertain to both registrants and applicants.”
Id.
at 42;
see also
R.D. 56 (“assuming Factor Two applies to both applicants and registrants”).

Contrary to the ALJ's understanding, there was no need to assume that Factor Two applies to registrants. As demonstrated by the several hundred agency decisions which have considered all five of the public interest factors in revocation proceedings brought against practitioners, it

does.
12

See, e.g., Thomas H. McCarthy,
54 FR 20936, 20938 (1989) (revoking registration and holding that “[a]n applicant's ‘experience in dispensing' (which includes prescribing and administering), made applicable to registrants by 21 U.S.C. 824(a)(4), is a statutory factor which ‘shall' be considered as set out in 21 U.S.C. 823(f)(2)”).

12
In addition to the cases involving practitioners, there are numerous published decisions of revocation proceedings brought against other categories of registrants (such as list I chemical distributors) in which the Agency considered all of the public interest factors applicable to the particular category of registrant.

In section 824(a)(4), Congress provided the Agency with authority to suspend or revoke a registration “upon a finding that the registrant . . . has committed such acts as would render his registration under section 823 of this title inconsistent with the public interest
as determined under such section.
” 21 U.S.C. 824(a)(4) (emphasis added). In section 823, Congress set for the registration requirements for each category of registrant under the CSA, including practitioners.
See
21 U.S.C. 823(f). With respect to practitioners, the Agency has long and consistently held that all five of the factors set forth in section 823(f) are to be considered in making the public interest determination.
See, e.g., McCarthy,
54 FR at 20938.

To be sure, factors two and three refer to “[t]he applicant's experience” and “[t]he applicant's conviction record,” rather than “the registrant's.”
Id.
As for why they do, the answer is obvious: The purpose of section 823 is to set forth the registration requirements,
i.e.,
the criteria for determining whether the granting of an application for registration is consistent with the public interest. Given that the initial determination of whether “issuance of [a] registration . . . would be inconsistent with the public interest,”
id.,
is made before an applicant is ever registered, it would make little sense to refer to “[t]he registrant's experience.” Indeed, none of the factors applicable to any of the seven categories of registrant set forth in section 823 refers to “the registrant.”

Implicit in the ALJ's reasoning is the notion that only those public interest factors which do not explicitly reference “the applicant” should be considered in a proceeding brought under section 824(a)(4). Not only does the ALJ's proposed construction place undue reliance on literalism while ignoring both the statute's context and Congress's purposes in enacting section 824(a)(4), it adoption would lead to strange results.

For example, in the case of a list I chemical distributor, four of the five factors used in making the public interest determination refer to the “the applicant.”
See
21 U.S.C. 823(h)(1)-(4). Accordingly, were I to adopt the ALJ's interpretation, in a revocation proceeding, these four factors would be rendered null and the only factor to be considered would be “
such other factors
as are relevant to and consistent with the public health and safety.”
Id.
§ 823(h)(5) (emphasis added). This begs the question of how the Agency would determine whether the factors asserted to be within this factor were truly “other” without having considered the other four factors.

Moreover, under the ALJ's interpretation, the factors to be considered in a revocation proceeding brought against a practitioner would vary from case to case, depending upon whether the practitioner had filed any pending applications. Thus, where the practitioner has not filed a renewal application (or an application to modify his registration), only factors one, four, and five could be considered in determining whether the acts he committed render his registration inconsistent with the public interest. However, upon the practitioner's filing of a renewal application (or application to modify), he would once again be an applicant and the Agency would then have authority (and be required) to consider all five factors in determining whether he had committed acts which “render his registration . . . inconsistent with the public interest.” 21 U.S.C. 824(a)(4). This is simply a prescription for inconsistent decisionmaking.

Notably, the Agency has never interpreted the CSA in the manner suggested by the ALJ. Thus, while some of the earlier decisions in cases brought under section 824(a)(4) did not explicitly cite factor two (or the other factors for that matter), the Agency has long considered factor two in revocation proceedings brought under section 824(a)(4).
See Tapia,
52 FR at 30459;
Elliott,
52 FR at 36312;
Chua,
51 FR at 41676-77. And in
McCarthy,
the Agency made explicit what was previously implicit (but was nonetheless the Agency's practice), when it held that “[a]n applicant's ‘experience in dispensing' . . . [is] made applicable to registrants by 21 U.S.C. 824(a)(4), [and] is a statutory factor which ‘shall' be considered” in a revocation proceeding. 54 FR at 20938.

The Agency's interpretation is fully supported by the legislative history of the Drug Enforcement Amendments to the Comprehensive Crime Control Act of 1984.
See
Public Law 98-473, § 512, 98 Stat. 2068, 2073 (1984). As the House Report explained, the “[i]mproper diversion of controlled substances by practitioners is one of the most serious aspects of the drug abuse problem. However, effective Federal action against practitioners has been severely inhibited by the limited authority in current law to deny or revoke practitioner registrations.” H.R. Rep. No. 98-1030, at 266 (1984),
reprinted in
1984 U.S.C.C.A.N. 3182, 3448. Continuing, the House Report explained that:

because of a variety of legal, organizational, and resource problems, many States are unable to take effective or prompt action against violating registrants. Since State revocation of a practitioner's license or registration is a primary basis on which

Federal registration may be revoked or denied, problems at the State regulatory level have had a severe adverse impact on Federal anti-diversion efforts. The criteria of prior felony drug conviction for denial or revocation of registration has proven too limited in certain cases as well, for many violations involving controlled substances which are prescription drugs are not punishable as felonies under State law. Moreover, delays in obtaining conviction allow practitioners to continue to dispense drugs with a high abuse potential even where there is strong evidence that they have significantly abused their authority to dispense controlled substances.

Clearly, the overly limited bases in current law for denial or revocation of a practitioner's registration do not operate in the public interest.

Id.

Congress thus amended section 823(f) “to expand the authority of the Attorney General to deny a practitioner's registration application” based upon a finding “that registration would be `inconsistent with the public interest,' ” by considering the five factors, which the House Report then set forth.
Id.
And Congress also amended section 824(a) “to add to the current bases for denial, revocation[] or suspension of registration a finding that registration would be inconsistent with the public interest
on the grounds specified in 21 U.S.C. § 823, which will include consideration of the new factors added by section 509, as discussed supra.
”
Id.
at 3449 (emphasis added). Notably, nowhere did the report suggest that the Agency should consider only those factors that do not use the words “the applicant.”

Accordingly, consistent with the Agency's longstanding interpretation,
13

in future cases brought against practitioners under section 824(a)(4), the ALJ should rest assured that factor two (as well as factor three) applies in making the public interest determination. So too, in any proceeding brought under section 824(a)(4), the ALJ shall, in making the public interest determination, consider all of the public interest factors set forth in the relevant provision of section 823. To the extent the evidence submitted by either party is relevant under a particular factor, the ALJ shall make the appropriate findings.

13
At the close of the hearing, the ALJ explained that while he had “seen court and DEA construction that assumes that factor 2 applies to registrants as well as applicants,” he was “in a learning curve here.” Tr. 500. The ALJ then explained that “I don't see how factor 2 applies here at all,” even though “I have seen cases that tell me that I should be construing factor 2 as though it's written for both the applicant and the registration [sic].”
Id.
at 500-01. The ALJ thus asked the parties to address “what your take is on that.”
Id.
The Government complied, yet even after the Government provided applicable precedent,
see
Gov't's Post-Hearing Br. 22-23 (citing
Thomas H. McCarthy,
54 FR 20936, 20938 (1989)), the ALJ was apparently still unconvinced.
See
R.D. at 42.

As stated above, there are several hundred Agency decisions which have applied factor two (as well as factor three) in section 824(a)(4) proceedings brought against practitioners. Moreover, having seen court decisions, none of which questioned the Agency's longstanding construction of the statute, there was no reason to require the parties to brief the issue or to ruminate as to whether factor two even applies. It does.
See Iran Air
v.
Kugelman,
996 F.2d 1253, 1260 (D.C. Cir. 1993) (quoting Joseph Zwerdling
, Reflections on the Role of an Administrative Law Judge,
25 Admin. L. Rev. 9, 12-13 (1973) (an ALJ “ `is governed, as is the case of any trial court, by the applicable and controlling precedents. These precedents include . . . the agency's policies as laid down in its published decisions . . . Once the agency has ruled on a given matter . . . it is not open to reargument by the administrative law judge' ”)).

However, the ALJ's failure to make findings under factor two does not alter the outcome of this matter. Because I agree with the ALJ's conclusions of law that there is substantial evidence that Respondent issued nine prescriptions to the undercover agents in violation of 21 CFR 1306.04(a), because he lacked a legitimate medical purpose and acted outside of the usual course of professional practice, and this conduct is also properly considered under factor four (compliance with applicable laws related to controlled substances), I adopt the ALJ's conclusion of law that “Respondent's continued [registration] is inconsistent with the public interest” and “warrant[s] the revocation of” his registration and the “the denial of any pending application.” R.D. 57. And for reasons explained earlier, I also adopt the ALJ's legal conclusion that Respondent authorized a prescription for hydrocodone after his registration had been suspended, and this conduct is also inconsistent with the public interest.
14

Id.
Finally, because Respondent has entirely failed to address the multiple acts of intentional diversion which he committed when he prescribed controlled substances to the undercover officers, I agree with the ALJ's conclusion of law that “Respondent has failed to affirmatively acknowledge specific acts of improper prescribing,”
id.
at 58, and that he has not put forward sufficient evidence to show why he can be entrusted with a registration.
See MacKay,
664 F.3d at 820. Accordingly, I will adopt the ALJ's recommendation that I revoke Respondent's registration and deny any pending applications to renew or modify his registration.
15

14
While I also adopt this conclusion, Respondent's violations in prescribing controlled substances to the undercover agents provides more than sufficient evidence to support the revocation of his registration.

15
For the same reasons that I ordered that Respondent's registration be immediately suspended, I conclude that the public interest necessitates that this Order be effective immediately. 21 CFR 1316.67.

Order

Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 824(a)(4), as well as 28 CFR 0.100(b), I order that DEA Certificate of Registration Number AP6572716, issued to Clair L. Pettinger, M.D., be, and it hereby is, revoked. I further order that any pending application of Clair L. Pettinger, M.D., to renew or modify the aforesaid Certificate of Registration, be, and it hereby is, denied. This Order is effective immediately.

Dated: September 18, 2013.
Michele M. Leonhart,
Administrator.

Paul Soeffing, Esq.,
for the Government

Alan Kaplan, Esq.,
for the Respondent

Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision of the Administrative Law Judge

Nature of the Case

Administrative Law Judge Christopher B. McNeil. Respondent Clair L. Pettinger, M.D., is registered with the Drug Enforcement Administration as an individual practitioner authorized to prescribe Schedule II-V controlled substances under DEA Certificate of Registration Number AP6572716, with an office at 4707 Greenleaf Court, Suite A, Modesto, California, 95356. His DEA Certificate of Registration expires by its own terms on March 31, 2015.
16

He also is licensed to practice medicine as a physician and surgeon in the State of California under license number G29874, which will expire by its own terms on March 31, 2015.
17

He has been licensed to practice medicine in the State of California since July 1, 1975 and has, heretofore, never been the subject of disciplinary actions by the DEA or by the State of California.
18

16
Per stipulation of the parties, see Order of February 5, 2013, ALJ Exhibit 13, at 1.

17
Tr. at 481.

18
Per stipulation of the parties, see Order of February 5, 2013, ALJ Exhibit 13, at 1.

On December 11, 2012, the DEA served Dr. Pettinger with an Order to Show Cause and Immediate Suspension of his DEA Registration dated December 10, 2012, whereby his DEA Certificate was suspended pursuant to 21 U.S.C. 824(d).
19

The Government alleged Dr. Pettinger distributed controlled

substances to five undercover law enforcement officers outside the usual course of professional practice or for other than a legitimate medical purpose, in violation of 21 U.S.C. 823(f)(4) and 841(a)(1), and 21 CFR 1306.04(a). Further, the Government alleged that Dr. Pettinger prescribed a high volume of controlled substances, particularly oxycodone through September 2012.
20

Based on this set of conditions, the Administrator suspended Dr. Pettinger's Certificate effective immediately and provided Dr. Pettinger with the opportunity to show cause why this immediate suspension should end and why the Administrator should not permanently revoke Dr. Pettinger's DEA Certificate.

19

Id.

20
At the hearing, the Government did not present evidence to support allegations in the Order to Show Cause that referred to Dr. Pettinger's prescription history. Order to Show Cause and Immediate Suspension of Registration, at paragraphs 4(a) through 4(e), pages 3-4. These allegations therefore are not currently before me.

While this matter was pending before me, the Government alleged further that after the Immediate Suspension Order was issued and a served upon Dr. Pettinger, Dr. Pettinger issued a new prescription dispensing hydrocodone to a patient on December 21, 2012.
21

21
Government Prehearing Statement at 4.

Statement of the Issue

The general issue to be adjudicated by the Administrator, with the assistance of this recommended decision, is whether the record as a whole establishes, by substantial evidence, that Dr. Pettinger's continued DEA registration is inconsistent with the public interest, as that term is used in Sections 303 and 304 of the Controlled Substances Act, Title 21, United States Code, Sections 823 and 824. Under this Act, the DEA may revoke the Certificate of Registration of a Registrant upon sufficient evidence establishing that the Registrant's continued registration is inconsistent with the public interest. Continued registration is inconsistent with the public interest if (among other bases) a Registrant who is otherwise authorized to prescribe controlled substances does so outside the usual course of his or her professional practice, or does so for other than a legitimate medical purpose. The specific issue is thus whether by at least a preponderance of the evidence the Government has established that Dr. Pettinger prescribed controlled substances to any of the five undercover agents outside the usual course of his professional practice or for other than a legitimate medical purpose.

Summary of the Evidence

The evidence in this record consists of recorded proceedings conducted during a brief hearing held in Arlington, Virginia on February 5, 2013 and a two-day hearing in Sacramento, California held on April 2-3, 2013, along with the documents admitted into evidence during those hearings. Included in the admitted exhibits are five audio recordings and six audio-visual recordings. By agreement of the parties, I listened to and, where appropriate, viewed the recordings after the evidentiary hearing was concluded. The contents of those recordings thus are part of the evidence now before me.

The Government's case is based in part on the testimony of five investigators who presented to Dr. Pettinger under assumed identities. Dr. Pettinger, who goes by Nate Pettinger, M.D., maintained a medical office under the name of Medical Cannabis of Northern California, or MCNC, at 2222 Watt Avenue Suite B1, Sacramento, California.
22

Each of the five government investigators worked for federal agencies, including the DEA, the United States Department of Health and Human Services, and the FBI.

22
Government Exhibit 25 at 1.

DEA Special Agent Robert Kittrell testified regarding the overall scope of this investigation. Each of the participating undercover agents testified regarding what they heard and saw during their interactions with Dr. Pettinger, describing the discussion and examinations that preceded Dr. Pettinger's issuance of a total of nine prescriptions for controlled substances. The Government then presented testimony from an expert medical witness regarding the nature of the examinations that led to Dr. Pettinger prescribing controlled substances to these undercover agents. The Government also called Dr. Pettinger as a witness, but after being sworn in and acknowledging his identity, Dr. Pettinger refused to answer further questions and invoked his Fifth Amendment right to avoid self-incrimination.

Although he did not testify on his own behalf, Dr. Pettinger presented testimony from an employee and two patients, with the intention of demonstrating that it would be improper to make generalizations adverse to Dr. Pettinger's regular practice based on the undercover activity. Without directly admitting to any violation of DEA diversion control regulations, Dr. Pettinger argues that the visits with the undercover agents are not indicative of his ordinary practice, urging that the Government's evidence does not establish that he has in any way endangered the public. Further, Dr. Pettinger urges that I find that he has taken remedial steps appropriate under the circumstances, such that further action by the DEA is not warranted.

After carefully considering the testimony elicited at the hearing, examining the admitted exhibits, evaluating the arguments of counsel, and weighing the record as a whole, I have set forth my recommended findings of fact, conclusions of law, and analysis below. Because I find that a preponderance of the evidence establishes that the Respondent's continued registration would be inconsistent with the public interest, I recommend the Administrator revoke Dr. Pettinger's DEA Certificate and deny any pending application for the same.

Testimony From DEA Special Agent Kittrell

Robert Kittrell is a DEA Special Agent with the Tactical Diversion Squad in the Sacramento District Office.
23

Agent Kittrell has been a criminal investigator with the DEA since 1991. He attended a 14-week training academy at Quantico, Virginia, studying subjects that included a review of drug laws, tactical training, training in the use of firearms, training in investigations, training in the use of undercover agents, and training in financial investigations.
24

He has furthered his studies through continuing education, including recent attendance at an 80-hour course in the investigation of controlled substance diversions involving pharmacies and doctors.
25

23
Transcript at 75.

24

Id.
at 75-6.

25

Id.
at 76.

Agent Kittrell described two kinds of controlled substance diversion: One involving drug gangs that send people to doctors' offices with the intent to get prescriptions for controlled substances; and the other involving what Agent Kittrell described as “rogue doctors” who “will prescribe controlled substances to people without medical necessity.”
26

He said that characteristics of such rogue doctors include prescribing the controlled substances that patients ask for, with little or no medical evaluation. He explained that these doctors “will not ask for a lot of medical records” and are “just getting the patients in, writing them the script and getting them out.”
27

26

Id.
at 76-7.

27

Id.
at 77.

Agent Kittrell said that he served as the Case Agent—the agent in charge of the DEA's investigation of Dr. Pettinger. He explained that an undercover investigator for the Department of Health and Human Services, Rob Breeden, approached him after Agent Breeden was able to obtain controlled substances without medical necessity.
28

In response, the team supervised by Agent Kittrell began investigating Dr. Pettinger.

28

Id.
at 77-8.

According to Agent Kittrell, agents in these cases are trained to approach the Certificate holder equipped with recording devices. The agents will sometimes simply ask for pills and may speak vaguely about medical problems. “They'll try to avoid answering questions. They won't provide any medical records or, if they do, they'll be falsified. . . . They won't complain of any immediate pain. They won't complain of any pain at all sometimes. They'll basically give every indication they can that the drugs are going to be diverted or that they're going to be abused or that there's no medical need for it.”
29

29

Id.
at 78-79.

On cross examination, Agent Kittrell elaborated on this approach, stating that undercover agents can be “vague” about whether they have any actual pain.
30

When asked whether the agents were instructed to attempt to divert the doctor's attention during these examinations, Agent Kittrell stated that “[w]e leave a lot of those things up to the undercovers themselves in each individual case because a lot of it has to do with what's going on at the time. You know, is it possible for an undercover agent to try to be friendly with the doctor when it happens? Absolutely. Does that include extraneous conversations? Absolutely.”
31

He agreed with the premise that during their preparation for undercover assignments, agents are “instructed to not act like a legitimate patient,” but instead are to act the way a drug-seeking patient would act.
32

30

Id.
at 95.

31

Id.

32

Id.
at 96.

Supporting the actions of the undercover agents were medical records and patient questionnaires prepared by the undercover officers and identified as Exhibits 25, 26, and 27.
33

According to Agent Kittrell, Agent Breeden completed Exhibit 25, which encompasses the patient questionnaire for a fictional patient named Danny Daly, when he visited Dr. Pettinger.
34

Similarly, FBI Special Agent Neeki Bianchi completed the patient questionnaire for a fictional patient named Nichole Hancock, shown as Exhibit 26.
35

DEA Special Agent Bob Ghazanfari completed the patient questionnaire for a fictional patient named Reza Soltani, shown as Exhibit 27.
36

Each of these records was submitted to Dr. Pettinger by the undercover agents, and was then recovered after Agent Kittrell obtained a search warrant to seize evidence from the doctor's office and residence.
37

According to Agent Kittrell, similar false medical files compiled for use by the other two undercover agents had been delivered to Dr. Pettinger in the course of the agents' visits, but were not located during subsequent searches of Dr. Pettinger's office or home.
38

They were, however, provided by Dr. Pettinger after Agent Kittrell requested them.
39

33

Id.
at 80.

34

Id.
at 81.

35

Id.

36

Id.
at 82.

37

Id.

38

Id.

39

Id.
at 103, and Respondent's Exhibits C and D.

Upon execution of the search and arrest warrants Agent Kittrell participated in questioning Dr. Pettinger. According to Agent Kittrell, Dr. Pettinger said that when presented with a pain management patient, “he does a complete physical workup and that includes blood pressure, heart rate, respiration, height, weight, and a complete physical exam.”
40

Dr. Pettinger told Agent Kittrell that in these cases he would request the patient's medical records, including any MRIs or x-rays, to evaluate the basis for the prescription being requested by the patient.
41

Dr. Pettinger told Agent Kittrell he would perform a complete physical exam again on follow-up visits.
42

According to Agent Kittrell, Dr. Pettinger stated “that he knew that he had a soft heart and that he was probably prescribing too much. He stated that about 20 percent of his patients were pill seekers and that 50 percent were probably receiving too many meds. He stated to me that he had received a lot of complaints from pharmacies, but if he was guilty of anything, he was guilty of not calling the pharmacies back, but he had been taking steps to correct that and trying to work with pharmacies so that they would accept his prescriptions.”
43

40
Tr.

at 85-6.

41

Id.
at 86.

42

Id.

43

Id.

According to Agent Kittrell, during this questioning Dr. Pettinger stated that if a patient came to him for pain medication and did not have any medical records, “he would only prescribe Norcos [hydrocodone] to begin with, which is a Schedule III narcotic.”
44

Further, he told Agent Kittrell that he was “taking steps to try to wean out or weed out problem patients . . . [and] if a patient came to him and stated that they were selling the pills, that he wouldn't write a prescription.”
45

Agent Kittrell stated that, in addition to these efforts, Dr. Pettinger told him he was trying to identify patients who were “double dipping,” in that they were obtaining controlled substances from more than one doctor at the same time.
46

According to Agent Kittrell, Dr. Pettinger reported that he was “really clamping down” on patients who appeared to be misusing medication and that as of July 2011 he had stopped accepting new patients.
47

Asked on cross examination whether that is exactly what the DEA expects doctors to do, Agent Kittrell agreed that if there is abuse of prescription medication, double-dipping, or the use of fraudulent medical records, a doctor should discharge the patient.
48

When asked whether this constitutes “remediation” by the doctor, Agent Kittrell stated, “Yes, it's like that,”—but clarified that this was “kind of like shutting the barn door after the cow got out[.]”
49

44

Id.
at 86.

45

Id.
at 87.

46

Id.
at 104.

47

Id.
at 105.

48

Id.
at 106-7.

49

Id.
at 108.

On cross examination Agent Kittrell agreed with the proposition that one way to verify whether Dr. Pettinger had engaged in remediation and reduced his prescribing would be to obtain patient activity reports from the California Substance Utilization Review and Evaluation (CURES) tracking system.
50

Agent Kittrell said he obtained “some” reports on Dr. Pettinger's patients from the CURES system, but he acknowledged that these reports were “not part of the evidence packages here.”
51

50

Id.
at 109.

51

Id.
at 110-1.

Agent Kittrell stated that he served an order of immediate suspension on Dr. Pettinger, telling him that “he was unable to dispense, prescribe, or otherwise issue controlled substances from that point on.” In response, Dr. Pettinger “stated that he understood that.”
52

Despite acknowledging this bar

to further prescribing, Dr. Pettinger did not stop writing prescriptions, according to Agent Kittrell.

52

Id.
at 87.

According to Agent Kittrell, the order of immediate suspension was delivered to Dr. Pettinger on December 11, 2012.
53

Exhibit 24 is a photocopy of a prescription for patient B.D., directing dispensation of 180 units of Norco 10/325 (indicating 10 mg of hydrocodone and 325 mg of acetaminophen). This prescription predates the December 11, 2012 order, and it allows for two refills. Also in Exhibit 24 is a photocopy of records from Safeway Pharmacy #2242, located in Sacramento, California. The Medical Expenses record (page 4 of Exhibit 24) reflects that the prescription was first filled on October 22, 2012, and then again on November 12, 2012, and on December 3, 2012. Thus, by December 3, 2012, all of the authorized dispensations under this prescription had been filled. According to Agent Kittrell, at this point if a pharmacy were to dispense any additional narcotics, the patient would need to produce a new prescription.
54

53

Id.
at 80.

54

Id.
at 92.

According to Agent Kittrell, despite being prohibited from prescribing controlled substances as of December 11, 2012, Dr. Pettinger authorized B.D. to receive an additional 180 units of Norco on December 21, 2012. Agent Kittrell identified a faxed Prescription Refill Request, shown at page 3 of Exhibit 24, and stated that this was a prescription issued by Dr. Pettinger after the effective date of the suspension order he received on December 11, 2012.
55

Agent Kittrell stated that while doing routine follow-up work regarding Dr. Pettinger, he contacted the pharmacist responsible for dispensing the Norco equivalent to B.D. He testified that the pharmacist told B.D. that there were no remaining refills on the initial prescription, so the pharmacist sent a fax to Dr. Pettinger's office. In response, the pharmacist received what has been marked as page 3 of Exhibit 24, through which Dr. Pettinger authorized the pharmacy to dispense 180 units of Norco to this patient.
56

To support his contention that this dispensation was the result of a new prescription and not simply the refilling of the earlier one, Agent Kittrell stated that a pharmacist would have no obligation to contact the prescribing source if the prescription had valid refills that had not yet been dispensed. Given that the pharmacist here did see the need to contact Dr. Pettinger, it follows that the earlier prescription could no longer serve as a basis for dispensing another 180 units of Norco—and that the faxed sheet constitutes a new prescription.
57

55

Id.
at 89.

56

Id.
at 91.

57

Id.
at 92.

Agent Kittrell added that, about four days after he spoke with the Safeway pharmacist, he got a call from Dr. Pettinger, who asked if he could authorize a new prescription for a patient to whom he had previously prescribed narcotics. Agent Kittrell said he told Dr. Pettinger no, that only prescriptions that were written prior to December 11, 2012 could be filled or refilled, but that Dr. Pettinger could not authorize any new prescriptions.
58

58

Id.
at 93.

On cross examination, Agent Kittrell agreed with the premise that there is nothing in Exhibit 24 that establishes that Dr. Pettinger knew D.B. had already filled and refilled the earlier prescription to its limit.
59

There is handwriting on page three of Exhibit 24 that uses the word “refill,” which Agent Kittrell agreed appears to have been written by Dr. Pettinger.
60

This page, captioned “Prescription Refill Request,” appears to have been faxed from Dr. Pettinger's office on December 21, 2012 (as it bears that designation on the bottom of the page). At the signature block, we see “N Pettinger MD—Can fill current refill No New Refill.” Above that, with an arrow pointing to the “No New Refill” language, there are two circles, one with “MD” and the other with “OK x 1”, indicating that the pharmacist contacted Dr. Pettinger and was told it was okay to dispense 180 generic Norco tablets, despite the fact that the pharmacy had already dispensed all of the medication authorized by the prescription written by Dr. Pettinger on October 22, 2012.
61

Despite the fact that the pharmacists would not have contacted Dr. Pettinger if refills remained on this prescription as of December 21, 2012, and despite the fact that the December 21, 2012 fax shows the pharmacist did contact Dr. Pettinger and was told it was okay to issue another 180 units of generic Norco, when Agent Kittrell was asked “You can't state sitting here today that Dr. Pettinger knowingly issued a new prescription on December 21, 2012, in violation of the suspension order?” he responded “Knowingly? No.”
62

While this evidence does not establish that the pharmacist told Dr. Pettinger that B.D. filled this prescription three times already, it does establish that Dr. Pettinger knowingly authorized another 180 unit dispensation after being called by the pharmacist, a condition that would not have existed had there been a refill available under the original prescription.

59

Id.
at 115.

60

Id.
at 116.

61
Government Exhibit 24 at 3.

62
Tr. at 116.

Agent Kittrell also agreed with the proposition that persons who lie to doctors in order to get prescription medications are committing crimes and that in such cases the doctors are, to a certain degree, victims of those crimes.
63

He agreed also that the five undercover agents who presented to Dr. Pettinger were engaged in acts that would be crimes if committed by private citizens.
64

Consistent with this theory, but after the close of the hearing and after the time set for offering evidence had passed, counsel for the Respondent submitted a copy of a letter sent to GreenLeaf Urgent Care dated April 2, 2013, from the U.S. Department of Justice. The letter is addressed to Dr. Pettinger and contains information provided pursuant to the Department's Victim Notification System. The letter states that Dr. Pettinger had been identified as a victim during an investigation involving twelve defendants, all of whom were named in the letter. The letter itself is silent with respect to the nature of the charges against these defendants, and does not indicate why or how Dr. Pettinger is regarded as a victim. The nexus between the letter and this administrative hearing is uncertain, but Respondent's counsel in his cover letter states that “[w]e believe that the individuals listed in the letter received or obtained controlled substances in Dr. Pettinger's name by means of criminal conduct for which they are now being prosecuted and which may also be relevant to the current DEA proceeding.” While not properly before me, this letter will be maintained as a proffer, identified in the record as ALJ Exhibit 22.

63

Id.
at 118.

64

Id.

Evidence From the Undercover Operatives

Robb Breeden works as a Special Agent for the United States Department of Health and Human Services in its Office of the Inspector General, out of the Sacramento, California field office.
65

He has worked there since 2007, and his training includes attendance at a fifteen week training course at the Federal Law Enforcement Training Center in Glencoe, Georgia, which included 120 hours of specialized tactical training and 120 hours of undercover training

that included the identification of pills and drug diversion.
66

65

Id.
at 122.

66

Id.
at 123.

According to Agent Breeden, after receiving an initial complaint regarding Dr. Pettinger, he made the first of four visits to the doctor's office using the fictitious name of Daniel Joseph Daly on November 10, 2011, using an audio recorder. The recording from that visit appears in the record as Government Exhibit 5, and is accompanied by a transcript of the conversations recorded during that visit.
67

67

Id.
at 123-4.

Acting as Mr. Daly, Agent Breeden appeared for an appointment at Dr. Pettinger's medical office on Watt Avenue in Sacramento.
68

He stated that upon his arrival at the office, he found the office was locked and that Dr. Pettinger was not present.
69

He stated that he then called Dr. Pettinger's cell phone and reached the doctor, who told him he would be at the office in a moment. Upon Dr. Pettinger's arrival, Agent Breeden greeted him while holding in one hand a small, travel-sized bottle of scotch whiskey.
70

Agent Breeden accompanied Dr. Pettinger into the doctor's office, where Agent Breeden gave the doctor some medical records, some paperwork, and an MRI report.
71

According to Agent Breeden, Dr. Pettinger noticed the bottle of scotch, commenting that it was easier to buy alcohol than cannabis.
72

68

Id.
at 124.

69

Id.
at 126.

70

Id.
and Government Exhibit 5, transcript at 1 (“let me get rid of my lunch here”).

71
Tr. at 126.

72

Id.
and Government Exhibit 5, transcript at 2 (Agent Breeden: “But I can't buy marijuana. It's stupid.” Dr. Pettinger: “Right. Well, I mean, that that's [unintelligible] you know, take the scotch and you can do that, but you can't end up getting marijuana. It seems crazy, doesn't it? The thing about it is you can't even kill a baby with marijuana unless you stuff their mouth so full they can't breathe; I mean you can't get enough into ’em to kill ’em.”)

Agent Breeden identified Government Exhibit 25 as a copy of the patient questionnaire form filled out at Dr. Pettinger's request. The first five pages of this form appear to be designed for a patient to provide identifying data and a medical history. As Agent Breeden noted in his testimony, the first page of Government Exhibit 25 (captioned “The California Compassionate Use Act of 1996, Eligibility Questionnaire”) includes a statement requiring the applicant to state whether he or she is a “law enforcement officer, undercover officer or investigator for the Federal Government, State of California, county, city, or any other organization therein here today with the intent of investigating Medical Cannabis of Northern California or Nate Pettinger, M.D.”

Pages 6 through 9 of Government Exhibit 25 are labeled “For Physician's Use Only,” and consist of a single-page form apparently filled out by Dr. Pettinger on each of the four visits referred to by Agent Breeden: November 10, 2011, December 6, 2011, January 13, 2012, and May 9, 2012. Page 10 of this exhibit is a copy of a Physician Statement and Recommendation dated November 10, 2011 on which is also a copy of a California Driver License issued to Daniel Joseph Daly, identifying Mr. Daly as “a patient whose possession and/or cultivation of medical cannabis is permissible” under California law, signed by Dr. Pettinger and Agent Breeden as Daniel Daly. Accompanying this Physician's Statement is a form captioned “Consent to Assume Risk for Medical Marijuana,” dated November 10, 2011, and signed by both Agent Breeden as Daniel Daly and Dr. Pettinger.

Also included in Government Exhibit 25 are photocopies of four prescriptions, whose dates match the dates of Agent Breeden's four office visits. In each instance, the prescriptions are signed by Dr. Pettinger under his office letterhead, and are for Oxycodone 30 mg IR [Instant Release]. In the prescription issued on the initial visit (November 10, 2011), Dr. Pettinger prescribed 120 units of this controlled substance. He prescribed 200 units in the prescription dated December 6, 2011, and 220 units for those dated January 13, 2012 and May 9, 2012.

After Agent Breeden completed the requested paperwork, he met with Dr. Pettinger in the doctor's office. He described the office as lacking things he would normally associate with a doctor's office: there was no examination table, no eye chart, no scale—only a cuff for taking blood pressure and a stethoscope.
73

Subsequent records, notably the video recordings at Exhibits 15, 17, 20 and 22, established further that the office that served for these examinations consisted of the doctor's office desk and two upholstered office chairs.

73
Tr. at 127.

Agent Breeden explained that during this initial visit, he and Dr. Pettinger spoke for quite a while about the use of cannabis.
74

He said at one point in the meeting, Dr. Pettinger did conduct a very brief physical examination, one that lasted “a couple of minutes” and consisted of Dr. Pettinger asking “a dozen or two health history questions very quickly” and then feeling along his spine, and took a reading of his blood pressure.
75

Although Agent Breeden complained of knee pain on his patient questionnaire,
76

Agent Breeden expressly denied that Dr. Pettinger ever actually saw either of his knees—as he never removed his pants during this office visit.
77

He said the only other physical contact with Dr. Pettinger came in the form of frisking the agent: “he patted me down. I think in my report at the time I thought he was patting me down for a weapon. He didn't focus on the knee. It was basically like a frisk like a law enforcement officer would do.”
78

74

Id.

75

Id.
at 127-8.

76
Government Exhibit 25 at 3.

77
Tr. at 162-3.

78

Id.
at 163.

The recording of this office visit confirms the substance of Agent Breeden's testimony: Dr. Pettinger spent a substantial percentage of this visit discussing how cannabis can be used medicinally. Although Agent Breeden told Dr. Pettinger he was experiencing knee pain, this subject did not come up in the conversation until 59 minutes had passed, and even then the topic was only briefly addressed by Dr. Pettinger. There is no evidence suggesting that Dr. Pettinger palpated the knee, checked for range of motion, or in any other way examined either of Agent Breeden's knees during this visit. Agent Breeden testified that at no time did Dr. Pettinger actually look at his knees.
79

79

Id.
at 133.

Further, although the initial prescription written by Dr. Pettinger based on this visit including both oxycodone and cough syrup with promethazine and codeine, there is nothing in this record indicating the patient was experiencing a cough or needed cough syrup. In addition, the “For Physician's Use Only” notes for the initial visit reflect clear respiration and full range of motion in the musculoskeletal system, indicating no medical basis for prescribing either pain medication or a cough suppressant.
80

The record does show that in the medical records he presented to Dr. Pettinger, Mr. Daly reportedly had told a Dr. Fazeri that he was experiencing esophageal problems, as a basis for obtaining cough syrup.
81

There is, however, no evidence indicating there were any complaints of cough presented during this initial meeting with Dr. Pettinger.

80
Government Exhibit 25 at 6.

81
Tr. at 155.

Further, the record shows Agent Breeden mentioned having been treated for a possible plantar wart, which Dr.

Pettinger agreed could result in back or knee problems.
82

There is, however, no evidence in the Daly records or in the patient interview by Dr. Pettinger establishing the patient actually had back problems—whether caused by plantar warts or by any other condition.

82

Id.

Agent Breeden was asked about the use of an MRI report in support of his request for pain medication. He said the MRI report is genuine and was based on an MRI he had taken at the Open Advantage MRI company, although instead of having his own name on the original report he altered it so that it appeared to refer to the fictitious Dan Daly.
83

He said he did not actually have anything wrong with his knees, but that the results indicated he had a medial meniscus tear—something he was not aware of, but later learned that “if you take anybody over the age of 30 almost all of them are going to have a torn meniscus.”
84

He testified that during the initial visit he presented this altered report to Dr. Pettinger, who received it and noted its receipt in the physician's note page (Government Exhibit 25, page 6).
85

Agent Breeden stated that at the start of each of the three subsequent visits to Dr. Pettinger's office, he was asked to produce the MRI, suggesting that the office had lost or misplaced the report.
86

Notwithstanding the fact that the MRI was not found in these records, Dr. Pettinger proceeded to prescribe oxycodone to Agent Breeden after each office visit.

83

Id.
at 164.

84

Id.
at 166.

85
Tr. at 133.

86

Id.

During cross examination, Agent Breeden was asked whether he had deliberately attempted to divert attention during the initial office visit with Dr. Pettinger, out of a concern that “the record was starting to show that Dr. Pettinger was genuinely trying to give you medical treatment[.]”
87

That does not, however, appear to be the case. In my review of the record and after listening to all of the audio recordings and watching all of the video recordings, I found the more persistent pattern was that Dr. Pettinger paused for significant periods of time during all of his patient visits, that he tended to speak slowly, quietly, and with deliberation; that the pauses were sometimes prompted by his need to write down observations or other notes in the patient medical files; and that the patients (not just Agent Breeden, but all of the undercover investigators) filled in these gaps by chatting with the doctor, typically discussing extraneous matters to which Dr. Pettinger had earlier referred. Examples of these include Dr. Pettinger's repeated references to notable football coaches Sandusky and Paterno; his description of using tinctures as a way of ingesting concentrated forms of cannabis; and the negative and hostile feelings he was experiencing after finding that someone had stolen the catalytic converter off of his car.

87

Id.
at 156.

I cannot conclude that the conversations engaged in by these agents were designed to divert Dr. Pettinger's attention or keep him from performing a proper, adequate physical examination. To the contrary, most of the extraneous dialogue recorded here was occasioned by Dr. Pettinger himself. The record does, however, make it clear that each of the undercover agents tried to act like drug-seeking patients—a point Agent Breeden acknowledged in cross examination.
88

88

Id.
at 157.

The record reflects that Agent Breeden's second visit to Dr. Pettinger's Watt Avenue office on December 6, 2011 was substantially the same as the first visit.
89

Notable in this context is the absence of evidence demonstrating that Dr. Pettinger performed any kind of physical examination of Agent Breeden's knee prior to Dr. Pettinger writing a prescription for oxycodone, and that most of the examination was spent discussing the medicinal use of cannabis. Agent Breeden stated that Dr. Pettinger asked no questions about his pain level, made no attempt to palpate Agent Breeden's knee, “did a quick palpation of my abdomen,” measured his blood pressure, and then ended the exam.
90

Also notable was that at this meeting, after discussing the versatility of cannabis for medicinal purposes, Dr. Pettinger issued a prescription for Marinol as a means for justifying the presence of the active ingredients in cannabis in Agent Breeden's bloodstream, should he ever have to submit to urinalysis or other drug screening after consuming products containing cannabis.
91

89

Id.
at 134-6 and Government Exhibit 7.

90

Id.
at 138.

91

Id.
at 137.

HHS Special Agent David Kvach accompanied Agent Breeden on his second visit to Dr. Pettinger's office. Agent Kvach has been a Special Agent for HHS since 2006. He has been trained at the Federal Law Enforcement Center and completed the Inspector General's investigative training course.
92

In 2008 he also completed the internal special agent course provided by HHS; he completed electronics and technical surveillance training in 2009; he completed advanced undercover and survival techniques training in 2010; he completed undercover school in 2012; and he completed training in the narcotics, vice, and street crimes supervisor course in 2013.

92

Id.
at 178.

In many respects, his initial visit to Dr. Pettinger's office resembled that of Agent Breeden. Using audio recording equipment and under the assumed name of Alex Gonza, Agent Kvach presented as a patient seeking medication for back pain.
93

Agent Kvach identified Respondent's Exhibit C, pages 3 through 7, as forms he filled out at this first visit.
94

The recording revealed a meeting that lasted more than an hour, although here again, as was the case with the initial meeting between Agent Breeden and Dr. Pettinger, most of the time was spent discussing medicinal uses of cannabis.
95

Agent Kvach described meeting with Dr. Pettinger after filling out some parts of these forms, and stated parts of the forms he left blank had later been filled in, although he could not say by whom.
96

In both Agents Breeden's and Kvach's reports, they noted that although they left unanswered those questions regarding cannabis use, the forms now show someone (presumably Dr. Pettinger) filled in answers to these questions, presumably based on what was discussed during these initial visits—although I find this was not always the case, and find substantial evidence that Dr. Pettinger included complaints and diagnoses (including insomnia and back pain) that were never raised by the undercover agents or that were flatly denied by the agents.

93

Id.
at 181.

94

Id.
at 182.

95
Government Exhibit 9, audio recording and transcript.

96
Tr. at 183-4.

Agent Kvach confirmed Agent Breeden's description of Dr. Pettinger's office, noting the absence of an examination table and the very limited amount of examination equipment, which included a blood pressure cuff and a stethoscope, and little else.
97

Unlike Agent Breeden, Agent Kvach brought no medical records with him for this first visit.
98

Agent Kvach noted that Dr. Pettinger wrote on the patient history form that the patient “will be bringing MRI,” but that never actually happened.
99

He explained further, on cross examination, that while Dr. Pettinger did not seek any x-rays, he did

ask Agent Kvach to obtain an MRI report: “He informed me that even if the MRI read out normal, he needed my MRI.”
100

97

Id.
at 185.

98

Id.
at 187.

99

Id.

100

Id.
at 201.

Agent Kvach described Dr. Pettinger's examination as “a cursory check” that included taking his blood pressure and putting a stethoscope under the agent's jacket, possibly to listen to his heart and lungs.
101

After this examination, Dr. Pettinger recommended medical marijuana and issued Agent Kvach a prescription for 120 units of oxycodone 30 mg IR, dated December 6, 2011.
102

101

Id.
at 185-6.

102

Id.
and Government Exhibit 8.

Agent Breeden returned for a third visit to Dr. Pettinger's office on January 13, 2012, the substance of which was recorded by audio recording and is transcribed at Government Exhibit 11. I would note that the first 38 minutes of this recording have not been transcribed. From my review of the audio recording, I understand that this part of the recording was not transcribed because it represents the time Agent Breeden was in Dr. Pettinger's waiting room, waiting for his appointment with Dr. Pettinger. The discussion recorded on the audio disc but not transcribed appears to be between Agent Breeden and Sean Ledford, the receptionist working in Dr. Pettinger's office. As Agent Breeden correctly stated, all interactions between himself and Dr. Pettinger have been transcribed.
103

Having listened to the discussion between Agent Breeden and Mr. Ledford, I note only that while the exchanges between Agent Breeden and Mr. Ledford have not been included in the written transcript, their absence is not legally significant.

103

Id.
at 141.

During this third visit, Agent Breeden introduced Dr. Pettinger to DEA Special Agent Daniel Patrick Moriarty, who was using the fictional name of Jason Kelly.
104

Agent Moriarty has worked as a DEA Special Agent since 2004. He completed basic and advanced training at Quantico, Virginia, on subjects including firearms and enforcing narcotics laws.
105

He testified about the one visit he made to Dr. Pettinger's office on January 13, 2012, and identified the video recording and transcript of that visit.
106

104

Id.
at 146, 241.

105

Id.
at 241.

106

Id.
at 242 and Government Exhibit 13.

Agent Moriarty testified that he presented to Dr. Pettinger as a patient seeking medication for pain relating to “knee issues.”
107

Agent Moriarty said he presented the same MRI report that Agent Breeden had presented at his initial visit with Dr. Pettinger (save for the fact that when Agent Moriarty presented it, the document had been altered using Photoshop to show the name of Jason Kelly instead of Dan Daly).
108

Agent Moriarty identified pages 2 through 6 of Respondent's Exhibit D as the questionnaire he filled out at his visit to Dr. Pettinger's office.
109

As was the case with Agents Breeden and Kvach, Agent Moriarty described filling out parts of these forms, and later finding answers that he himself did not provide—including a claim of insomnia, which he stated he did not make either when filling out the form or during the patient interview that followed.
110

107
Tr. at 247.

108

Id.
at 248, 276.

109

Id.
at 269.

110

Id.
at 270.

Agent Moriarty described his initial visit with Dr. Pettinger in terms similar to those presented by Agents Breeden and Kvach. He said Dr. Pettinger's exam included taking his blood pressure and pulse, and that he then “walked around his desk to where I was seated and kind of I guess pushed my shoulders or touched my shoulders. He had a reflex tool and tapped each knee. That's kind of it. I think he looked in my ears.”
111

He said the entire exam was performed while he was seated in the office chair next to the doctor's desk, and that the doctor never required the agent to remove his jeans in the course of this exam.
112

Based on this examination, Agent Moriarty was able to obtain a prescription for 180 units of oxycodone 30 mg IR.
113

111

Id.
at 271.

112

Id.
at 272.

113

Id.
at 273 and Government Exhibit 12.

Agent Kvach returned to Dr. Pettinger's office on January 24, 2012, for a second visit, this time accompanied by FBI Special Agent Neeki Bianchi.
114

Agent Bianchi has been a Special Agent with the FBI for nine years.
115

She stated that during this service, she trained for four months in Quantico, Virginia, and has subsequently been trained in counterterrorism, healthcare fraud, and undercover operations.
116

She said she made one undercover visit to Dr. Pettinger's office using the name Nicole Hancock, and identified Government Exhibit 17 as a video recording and transcript of that visit.
117

114
Tr. at 189.

115

Id.
at 221.

116

Id.

117

Id.
at 222, 224.

According to Agent Bianchi, she and HHS Special Agent Kvach represented to be boyfriend and girlfriend for this visit and met jointly with Dr. Pettinger, with Agent Kvach returning in his role as Alex Gonza.
118

Both Agent Bianchi and Agent Kvach recorded this meeting, although for approximately ten minutes Agent Kvach absented himself from the office visit so that he could use the men's restroom and smoke a cigarette. Regrettably, both of those events are part of the video recording offered by the Government as Exhibit 15, although they lend no substance to this report. On the other hand, the recording created by Agent Bianchi (found at Government Exhibit 17) captured without interruption the entire office visit she and Agent Kvach had with Dr. Pettinger on January 24, 2012.

118

Id.
at 224.

In her testimony, Agent Bianchi summarized her meeting with Dr. Pettinger. She recalled telling Dr. Pettinger she used cannabis recreationally, but that she was meeting with him in order to get a prescription for pain medication.
119

During the joint interview, Agent Kvach in his role as Alex Gonza told Dr. Pettinger that Ms. Hancock had been using his oxycodone, and Agent Bianchi did not dispute this, but instead stated she was there to obtain an oxycodone prescription for her own use.
120

When Dr. Pettinger asked whether she was experiencing pain, she said no; and she gave the same answer when he asked whether she was having difficulty sleeping.
121

When he asked why she needed pain medication, Agent Bianchi responded by saying the medication makes her talkative and happy.
122

In response, Dr. Pettinger told Agent Bianchi that in order to obtain a prescription for oxycodone, she would need to arrange to have an MRI taken and have the results filed with his office.
123

When Agent Bianchi asked Dr. Pettinger how to go about getting an MRI, specifically asking him what kind of pain she needed to report in order to justify getting an MRI that would serve this purpose, Dr. Pettinger told her to report pain in her back that radiates down to her leg.
124

Before ending this office visit, Dr. Pettinger checked Agent Bianchi's blood pressure and “ran his hand from [her] lower back to [her] upper back[.]”
125

At that point, Dr. Pettinger wrote a prescription authorizing an MRI, recommended her for medical marijuana, and issued a

prescription for 90 units of oxycodone 30 mg IR.
126

119

Id.
at 225 and Government Exhibit 17.

120
Tr. at 225.

121

Id.
at 226-7 and Government Exhibit 17.

122
Tr. at 226 and Government Exhibit 17.

123
Tr. at 226.

124

Id.

125

Id.

126

Id.
at 227 and Government Exhibit 16 at 1-2, Government Exhibit 26 at 8-9.

As was the case when Agents Breeden and Kvach first met with Dr. Pettinger, Agent Bianchi testified that although she left many of the questions unanswered in the initial patient questionnaire, Dr. Pettinger appears to have filled in answers that had been left blank—in any event, the agent stated she herself did not answer these questions, and assumed the answers were written in by Dr. Pettinger. She expressly denied any complaint of insomnia or back pain, although these ailments were listed as medical complaints in her patient questionnaire.
127

127
Tr. at 230 and Government Exhibit 17.

DEA Special Agent Babak Ghazanfari testified about his visit to Dr. Pettinger's office. Agent Ghazanfari has worked for the DEA for approximately five years, and is currently assigned to the Tactical Diversion Squad in the Sacramento District Office.
128

His training includes completion of approximately nineteen weeks of training at the Justice Training Center in Quantico, Virginia on all aspects of drug enforcement, including surveillance techniques, defensive tactics, and arrest procedures.
129

128
Tr. at 279.

129

Id.

Agent Ghazanfari said he went to Dr. Pettinger's Modesto, California office on March 20, 2012, and identified Government Exhibit 20 as the audiovisual recording of that visit. Using the fictional name of Reza Babak Soltani, Agent Ghazanfari completed the patient questionnaire shown in Government Exhibit 27, and met with Dr. Pettinger shortly thereafter.
130

Agent Ghazanfari testified that although Dr. Pettinger's physician notes indicate a complaint of left knee pain, the agent never made any such complaint to Dr. Pettinger—a point that is confirmed by the recording made during this office visit. To the contrary, when Dr. Pettinger asked “so the knee is what's bothering you?” Agent Ghazanfari responded “well, used to, used to” and when the doctor followed that with “so the weather gets to you a little bit with it?” the agent responded “nah, it's not really bothering me all that much.”
131

130

Id.
at 284.

131
Government Exhibit 20, audio-video recording and transcript at 7.

The record establishes that Nikki, who was Dr. Pettinger's assistant at the Modesto office, took Agent Ghazanfari's blood pressure,
132

and Dr. Pettinger himself used an otoscope to examine the agent's ears, and used a stethoscope to examine heart and lung sounds.
133

According to Agent Ghazanfari, Dr. Pettinger conducted “a patdown, touched certain parts of my body, rubbed my neck, kind of felt around me, tapped on my knees a little bit, and then he put his stethoscope up to my heart or the area of my heart and began to tell me that I had some irregular heart beat or something to that effect,” all while the agent remained seated.
134

Dr. Pettinger also had the MRI Agent Breeden referred to, this time altered to reflect that it referred to Reza Soltani.
135

When Dr. Pettinger inquired about the medication Agent Ghazanfari was currently taking, he responded by saying he was taking Percocets, Norcos, and oxys, and that “oxys are the ones that do it for me,” but that he was obtaining them from the street, not through any valid prescriptions.
136

At the conclusion of this meeting, Dr. Pettinger presented the agent with a prescription for 150 units of oxycodone 30 mg IR.
137

132
Tr. at 286.

133
Government Exhibit 20, audio-video recording and transcript at 17.

134
Tr. at 288.

135
Tr. at 285.

136

Id.
at 292 and Government Exhibit 20, audio-video recording and transcript at 12.

137
Tr. at 289 and Government Exhibit 19.

Agent Breeden made one final visit to Dr. Pettinger's office, on May 9, 2012.
138

During this visit, much of the time the doctor spent with Agent Breeden was dedicated to discussing problems Dr. Pettinger was having with pharmacists, who were starting to reject his prescriptions.
139

Dr. Pettinger made the point that he “wrote more prescriptions [for oxycodone] than 50 doctors combined,” and was irritated by questions presented to him by pharmacists, some of which arose because his first name is Clair, which leads on occasion to uncertainty about whether the prescribing doctor is male or female, resulting in a lot of unnecessary questions.
140

138
Tr
.
at 147.

139

Id.
at 149 and Government Exhibit 22.

140

Id.

Agent Breeden described Dr. Pettinger performing a medical exam that was similar to previous exams, in that it was short and involved only a blood pressure check and stethoscope monitoring of the chest area.
141

At one point in this meeting, Agent Breeden told Dr. Pettinger that he had used some of the prior oxycodone prescription to “pay back” a third person, at which point Dr. Pettinger told him that he would not continue to issue prescriptions for oxycodone if the patient was selling or giving pills away.
142

When Agent Breeden assured Dr. Pettinger he would no longer give away or sell his pills, Dr. Pettinger wrote a prescription for 220 units of oxycodone 30 mg IR.
143

141

Id.

142

Id.

143
Tr. at 150 and Government Exhibit 21.

When asked on cross-examination whether h

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2013-24052. Public record. Not legal advice.
