Roger A. Pellmann, M.D.; Revocation of Registration, 17704-17710 [2011-7411]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 76, Number 61 (Wednesday, March 30, 2011)]
[Notices]
[Pages 17704-17710]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7411]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Roger A. Pellmann, M.D.; Revocation of Registration

    On January 29, 2010, I, the Deputy Administrator of the Drug 
Enforcement Administration, issued an Order to Show Cause and Immediate 
Suspension of Registration (Order) to Roger A. Pellmann, M.D. 
(Respondent), of Germantown, Wisconsin. The Order proposed the 
revocation of Respondent's registration, AP1892822, on the ground that 
his ``continued registration is inconsistent with the public interest, 
as that term is defined in 21 U.S.C. 823(f) and (g)(2)(E)(i).'' Order, 
at 1.
    The Order alleged that Respondent ``possessed and dispensed 
controlled substances at 3129 S. Ridge Crest, New Berlin, Wisconsin,'' 
an unregistered location, in violation of 21 U.S.C. 841(a)(1). Order, 
at 1. The Order further alleged that beginning ``in approximately June 
2009,'' Respondent ``prescribed controlled substances to an employee 
for other than legitimate medical purposes,'' in violation of 21 U.S.C. 
841(a)(1) and 21 CFR 1306.04. Id. at 2. The Order also alleged that at 
Respondent's ``request,'' a local pharmacy dispensed controlled 
substances which were ``returned'' to Respondent for his ``personal 
use,'' in violation of 21 U.S.C. 843(a)(3). Id.
    Next, the Order alleged that an ``accountability audit performed at 
[Respondent's] office in November 2009'' found ``an unexplained 
shortage of approximately 10,470 fentanyl citrate 0.05 mg/ml (2 ml 
ampule) during the first audit and an unexplained shortage o[f] 
approximately 9,556 fentanyl citrate 0.05 mg/ml (2 ml ampule) during 
the second audit.'' Id. The Order also alleged that ``accountability 
audits for morphine sulfate indicated a shortage of approximately 780 
units of morphine sulfate injection 15 mg/ml (20 ml vial); 1825 units 
of morphine sulfate injection 10 mg/ml (1 ml vial); 550 units of 
morphine sulfate injection 8 mg/ml (1 ml vial); and 200 units of 
morphine sulfate injection 5 mg/ml (1 ml vial).'' Id. Finally, the 
Order alleged that ``[n]o initial inventory was taken upon the 
establishment of the registered location, nor was a biennial inventory 
taken of the controlled substances on the premises of the registered 
location every two years'' and that ``records were not properly 
maintained for the dispensed controlled substances.'' Id. (citing 21 
CFR 1304.11, 1304.11(b) & (c), and 1304.22(c)). Based on the above, I 
concluded that Respondent's continued registration during these 
proceedings ``constitutes an imminent danger to the public health and 
safety'' and immediately suspended his registration. Id. (citing 21 
U.S.C. 824(d)).
    On February 24, 2010, Respondent timely filed a request for a 
hearing on the allegations. The matter was placed on the docket of the 
DEA Administrative Law Judges (ALJ) and was set for hearing on June 22, 
2010. Order Terminating Proceeding, at 1. However, on June 7, 2010, 
counsel for Respondent notified the ALJ that following Respondent's 
criminal conviction after trial ``on facts related to the allegations 
set forth'' in the Order, he ``no longer wished to pursue a hearing.'' 
Id. The same day, Respondent's Counsel also wrote a letter to the ALJ 
stating that he was ``waiving his opportunity to participate in the 
hearing'' and submitting his statement of facts and his position. 
Letter from Adam C. Essling (June 7, 2010), at 1 (citing 21 CFR 
1301.43(c)).
    Mr. Essling's letter additionally stated that Respondent 
``maintains that his registration is not inconsistent with [the] public 
interest under 21 U.S.C. 823(f).'' Id. More specifically, the letter 
related that Respondent ``maintains that [J.E.] has been a patient of 
his since 2005'' and that ``[a]ll of the controlled substances provided 
to [J.E.] were for a legitimate purpose.'' Id. However, the letter 
conceded that Respondent ``did not maintain a proper inventory or 
records for the controlled substances dispensed within the scope of his 
practice.'' Id.
    By order of June 8, 2010, the ALJ terminated the proceeding. Order 
Terminating Proceeding, at 2. Thereafter, the Investigative Record was 
forwarded to me for Final Agency Action.
    Based on relevant evidence contained in the Investigative Record, I 
conclude that Respondent has committed acts which render his 
registration ``inconsistent with the public interest.'' 21 U.S.C. 
824(a)(4). I will therefore, order that Respondent's registration be 
revoked and that any pending applications to renew or modify his 
registration be denied. I make the following findings of fact.

Findings

    Respondent is a physician licensed by the State of Wisconsin who 
practices radiology. Respondent also holds DEA Certificate of 
Registration, AP1892822; the registration, which does not expire until 
March 31, 2011, authorizes him to dispense controlled substances as a 
practitioner at the registered location of CMI--Center for Medical 
Imaging, W178 N9912 Rivercrest Drive, Suite 102, Germantown, Wisconsin 
(``CMI,'' or ``Germantown clinic''). Certificate of Registration Status 
(March 11, 2010). However, on January 29, pursuant to my authority 
under 21 U.S.C. 824(d), I ordered that Respondent's registration be 
immediately suspended; Respondent was served with the Order on February 
2, 2010.
    On September 4, 2009, a confidential source (CI) informed a DEA 
Diversion Investigator (DI) that Respondent had ``been providing [J.E.] 
with large quantities of liquid Fentanyl and morphine sulfate, both of 
which are Schedule II controlled substances,\1\ for

[[Page 17705]]

no legitimate medical purpose and that [J.E.] is addicted to these 
drugs.'' Affidavit of G. Connor, at 2-3. The CI further stated that 
J.E. and Respondent had been involved in a sexual relationship for the 
past two years, and that J.E. worked at Respondent's Germantown clinic, 
but ``since approximately June 2009,'' had ``been doing most of her 
work at home because she [was] too addicted to narcotic drugs to go to 
the office.'' Id. at 3.
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    \1\ See 21 CFR 1308.12(b)(1)(ix) & (c)(9). According to the FDA-
approved package insert for fentanyl citrate injection, a dosage of 
0.1 mg in 2 ml. solution is ``approximately equivalent in analgesic 
activity to 10 mg of morphine''; fentanyl is thus approximately 100 
times more powerful than morphine. Its approved uses are primarily 
for analgesic action ``during anesthetic periods, premedication, 
induction and maintenance, and in the immediate postoperative 
period'' as needed, and also as ``a narcotic analgesic supplement in 
general or regional anesthesia.'' Other uses include 
``administration with a neuroleptic such as droperidol injection as 
an anesthetic premedication, for the induction of anesthesia, and as 
an adjunct in the maintenance of general and regional anesthesia,'' 
and ``as [an] anesthetic agent with oxygen in selected high risk 
patients, such as those undergoing open heart surgery or certain 
complicated neurological or orthopedic procedures.''
    The package insert furthers that the drug ``SHOULD BE 
ADMINISTERED ONLY BY PERSONS SPECIFICALLY TRAINED IN THE USE OF 
INTRAVENOUS ANESTHETICS AND MANAGEMENT OF THE RESPIRATORY EFFECTS OF 
POTENT OPIODS. AN OPIOD ANTAGONIST, RESCUCITATIVE AND INTUBATION 
EQUIPMENT, AND OXYGEN SHOULD BE READILY AVAILABLE.''
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    According to the CI, approximately two years earlier, the CI was at 
J.E.'s residence when J.E. complained of a migraine headache; J.E. 
called Respondent and asked him to bring something for her headache. 
Id. Respondent later arrived ``with an IV bag * * * an IV bag holder, 
several vials and syringes.'' Id. at 3. At that point, the CI left the 
premises. Id.
    The CI further stated that several months earlier the company 
underwriting Respondent's employees' health insurance had informed 
Respondent that the plan might not ``be renewed because of the high 
number of prescriptions [Respondent] was writing for Schedule II 
controlled substances for one of the employees at the clinic.'' Id. at 
4. The CI further stated that clinic employees filled their 
prescriptions at Walgreen's pharmacies. Id.
    A DI obtained records of all the prescriptions written by 
Respondent and filled at ``Walgreens pharmacies located in southeastern 
Wisconsin during the two-year period from September 1, 2007 through 
August 31, 2009.'' Id. at 6. The records showed that Walgreen's had 
filled 409 prescriptions issued by Respondent for narcotic controlled 
substances in this period, of which ``138 (approximately 35%) had 
been'' issued for J.E. Id.
    The prescriptions for J.E. included six for morphine sulfate, ten 
for oxycodone, and two for fentanyl patches (or its generic 
equivalent), all of which are Schedule II controlled substances. Id.; 
see 21 CFR 1308.12(b)(1)(xiii). The prescriptions filled for J.E. also 
included approximately 109 prescriptions for hydrocodone and seven 
prescriptions for Hydromet, a hydrocodone-based cough syrup, both of 
which are Schedule III controlled substances. Affidavit of G. Connors, 
at 6; see 21 CFR 1308.13(e)(1).
    J.E.'s prescriptions also fell into a pattern, with the number of 
dosage units of oxycodone or hydrocodone increasing from 90 to 170 
dosage units per month in 2007 to as much as 380 dosage units by 
January 2009; in addition, during 2008 and 2009, Respondent added 
morphine sulfate and fentanyl patches to J.E.'s prescriptions. 
Affidavit of G. Connors, at 7. However, in July 2009, Respondent's 
prescriptions for J.E. ``decreased dramatically''; a Special Agent (SA) 
attributed this to Respondent's insurance company having told him that 
it might cancel his clinic's employee-health insurance. Id.
    A DI obtained data from ARCOS, DEA's Automated Reports and 
Consolidated Order Systems database. The data showed that while in 
2008, Respondent had not obtained any schedule II or III controlled 
substance, in June 2009; he ordered and received 1,000 dosage units of 
fentanyl and 250 dosage units of morphine sulfate. Id. at 8. Also, in 
July 2009, Respondent ordered and received 1,280 dosage units of 
fentanyl and 280 dosage units of morphine sulfate; in August 2009, he 
ordered and received 1,660 dosage units of fentanyl and 280 dosage 
units of morphine sulfate; and in September 2009, he ordered and 
received 3,100 dosage units of fentanyl and 280 dosage units of 
morphine sulfate. Id. As the SA noted, ``[t]his substantial increase in 
[Respondent's] ordering of controlled substances generally coincided 
with the substantial reduction in the number of prescriptions for 
controlled substances, which were written by [Respondent], and filled 
by [J.E.] at Walgreens pharmacies.'' Id.
    On November 3, 2009, a DI, with assistance from the Waukesha Metro 
Drug Enforcement Unit, conducted a search of the garbage at J.E.'s 
residence. Id.; Declaration of K. Federico, at 1. The officers found 
421 empty 2-ml. ampules labeled ``Fentanyl Citrate 100mcg./1ml.,'' 
thirteen (13) empty 1-ml ampules labeled ``Morphine Sulfate 8mg./
1ml.,'' one (1) empty 20-ml. bottle labeled ``Morphine Sulfate 15mg./
1ml.,'' and numerous syringes and used alcohol pads. Affidavit of G. 
Connors, at 8; Declaration of K. Federico, at 1.
    On November 10, 2009, DEA SAs obtained warrants to search both 
Respondent's Germantown clinic and J.E.'s residence. Affidavit of E. 
Roy, at 2. On November 12, 2009, during the execution of the search 
warrant at the Germantown clinic, the SAs interviewed Respondent. Id. 
at 3. Respondent stated that J.E. was one of two registered nurses 
employed by his practice and that she was also the vice president of 
CMI. Id. Respondent further stated that he had been treating J.E. since 
approximately March 2009 for pain ``resulting from a fractured tooth.'' 
Id. Respondent maintained that the tooth subsequently became infected 
and that he then started treating J.E. with liquid fentanyl. Id.
    Respondent further stated that he initially injected J.E. with 
three to five 2-ml. ampules of fentanyl three times per day, but by the 
time of the interview, he was injecting her with approximately fifty 
ampules per day. Id. He also stated that he had prescribed Vicodin for 
J.E.'s lower back pain and that J.E. was intermittently taking 
hydrocodone along with the fentanyl for her pain. Id.
    Respondent stated that J.E. had not been billed for any of the 
fentanyl which he had provided to her. Id. at 4. He further admitted 
that he did not have a medical file or chart documenting his treatment 
of J.E. and a search of the clinic failed to yield a medical record for 
J.E. Id. at 4, 6.
    Respondent also stated that he had had several conversations with 
J.E. in which he told her that she needed a longer-acting narcotic than 
fentanyl. Id. at 4. However, J.E. did not want to change medications. 
Id. Nevertheless, Respondent tried J.E. on morphine sulfate, which left 
her with a ``drug hangover'' the next morning. Id. Respondent also 
admitted that J.E. had developed a tolerance to fentanyl and was 
addicted to it. Id. Respondent further admitted that he did not think 
his dispensing of fentanyl and morphine sulfate to J.E. was ``in the 
usual course of practice,'' and that ``the situation going on between 
himself and [J.E.] [was] not in the usual course of practice.'' Id. He 
also admitted that he never conducted an inventory of the controlled 
substances kept at his clinic. Declaration of S. Osborne, at 4.
    Respondent further admitted that he self-administered morphine 
sulfate for a neck injury and that sometimes J.E. assisted him with the 
injections. Affidavit of E. Roy, at 8; Declaration of K. Federico, at 
1. Based on this information, DEA contacted his attorney regarding 
``his possession and personal use of morphine.'' Affidavit of E. Roy, 
at 8. On November 19, 2009, the attorney turned over to DEA a box 
intended to hold ten smaller boxes, each of which holds twenty-five 1-
ml. ampules of morphine. Id. at 8-9. However, the box contained only 
nine of the smaller boxes of morphine ampules. Id. at 9.
    DEA audited the records of the Germantown clinic and found 
significant discrepancies in the amount of fentanyl received and used 
by Respondent. In the period from

[[Page 17706]]

February 26, 2009, when records indicated Respondent had ninety-four 
ampules of fentanyl in stock, through November 12, 2009, he received 
11,490 such ampules.\2\ Id. at 5. At the time of the search, he had 
seven ampules on hand, plus DEA found another 600 ampules in his car, 
which Respondent claimed he was taking to his home because of a theft 
at the clinic. Id. No dispensing logs for September or October 2009 
were found, and the remaining dispensing logs accounted for the 
disposition of only 507 ampules, less than ten percent of what had been 
received in this period. Id.
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    \2\ Pharmacy records from Ye Olde Pharmacy, where Respondent 
filled his ``general use'' prescriptions for controlled substances 
for ``office use,'' indicate that between February 1, 2009 and July 
14, 2009, Respondent obtained 4,100 ampules of fentanyl. See 
Declaration of S. Osborne, at 2-3. ARCOS data from June through 
September 2009 indicate that he obtained a further 7,040 ampules 
from distributors for a total of 11,140 ampules. It is not clear 
what accounts for the difference between the 11,490 figure and the 
total of 11,140.
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    The Germantown clinic had a record of all patients who had received 
fentanyl as part of a medical procedure for the period June 1, 2009 
through November 12, 2009. Id. at 6. While during this period 
Respondent purchased 10,590 ampules of fentanyl, the clinic records 
showed that only 427 ampules were used during medical procedures at the 
clinic. Id. These ampules, combined with the 600 found in the car, 
likewise account for less than ten percent of the fentanyl Respondent 
received. Id.
    The Investigators also performed an audit of Respondent's handling 
of morphine sulfate for the period February 26, 2009 through November 
12, 2009. The audit showed that Respondent could not account for 3,155 
vials of the drug, which was ``the majority of the morphine sulfate he 
received'' in that period.\3\ Declaration of S. Osborne, at 2. 
According to several clinic employees, morphine ``was not used in 
CMI['s] procedures.'' Id. Moreover, the search of the clinic revealed 
that Respondent ``failed to take an initial inventory [and] maintained 
no biennial inventory'' for any of the controlled substances Respondent 
had obtained; nor did it have proper records documenting the 
disposition of the morphine that Respondent obtained. Id. at 3.
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    \3\ Dispensing records from Ye Olde Pharmacy indicate that 
Respondent received 2,025 dosage units of morphine sulfate between 
February 2009 and July 14, 2009. ARCOS data for the months of July 
2009 through September 2009 indicate that in this period, Respondent 
obtained a further 1,010 vials of morphine sulfate, making for a 
total of 3,035 vials. Respondent, however, could account for only 
100 vials.
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    On November 12, 2009, DEA Investigators also conducted a consensual 
search of Respondent's residence. Declaration of K. Federico, at 1. 
While Respondent's residence is not a registered location, the 
Investigators found ``large amounts of empty and full fentanyl citrate 
ampules, morphine sulfate vials, drug packaging, and intravenous drug 
use paraphernalia.'' Id.
    On November 19, 2009, DEA received information from a second 
confidential source (CI2) that on November 16, 2009, Respondent had 
received a box of morphine; according to CI2, morphine was not used in 
the clinic's procedures. Affidavit of E. Roy, at 8. CI2 later observed 
Respondent placing one of the containers of morphine in his pocket. Id.
    On November 23, 2009, pursuant to an immunity agreement with the 
U.S. Attorney's Office, J.E. was interviewed by DEA investigators. Id. 
at 6. J.E. stated that Respondent gave her Vicodin for back pain in 
2007. Id. He also prescribed oxycodone, morphine sulfate, and fentanyl 
patches on several occasions for pain management. Id.
    J.E. stated that around the summer of 2009, Respondent provided 
J.E. with fentanyl for a dental problem. Id. Respondent began 
administering the fentanyl to J.E. via an intravenous (IV) line on a 
regular basis. Id. J.E. stated that she consumed two to three vials per 
week this way. Id. She also indicated that morphine made her sleepy and 
that sometimes Respondent would give her morphine to help her sleep. 
Id. at 7.
    As J.E.'s dental problem worsened, her use of fentanyl increased. 
Id. Rather than receive the drug via IV administration, she began 
injecting herself with a solution of fentanyl and saline. Id. By 
November 12, 2009 (when the search warrant was executed at her 
residence), J.E. was self-administering approximately forty to fifty 
vials of fentanyl per day. Id. She was also receiving morphine from 
Respondent to help with her sleep several times each week. Id. While 
typically Respondent brought the drugs to her residence, on a few 
occasions another clinic employee brought them. Id.
    In addition, at times J.E. would go to Respondent's house to use 
fentanyl or morphine that Respondent kept there. Id. J.E. stated that 
she never paid for medication or treatment provided by Respondent. Id. 
She further stated that every few weeks she and Respondent would have 
conversations about her growing tolerance to fentanyl. Id.
    On November 11, 2009, J.E. checked herself into a treatment center, 
where she stayed until November 18, 2009. Id. at 8. She further told 
Investigators that she was receiving treatment from a physician for her 
fentanyl addiction and was taking Suboxone as part of that treatment. 
Id.
    On January 11, 2010, DEA received further information from CI2. CI2 
told the Investigators that in the last week, Respondent had noted on 
CMI's dispensing log that he had dispensed 250 ampules of fentanyl to 
J.E. Id. at 9. CI2 also stated that he had noticed that fifty ampules 
of fentanyl were missing and were not accounted for in the dispensing 
log. Id. He also reported discovering three plastic zip-lock bags in 
the Germantown clinic's trash containing empty fentanyl ampules, 
syringes, dirty cotton pads, and other items; CI2 provided the bags to 
DEA. Id. According to CI2, CMI disposes of needles in a ```sharps' bio-
hazard container,'' and not via the trash. Id.
    DEA Investigators examined the three plastic bags. They found 
thirty-eight empty fentanyl ampules, four empty plastic trays (each 
capable of holding ten (10) fentanyl ampules), syringes, needles, 
alcohol swabs, gauze dirtied with blood, ``Y'' adapters for an IV line, 
and packaging for needles. Id. at 10.
    On January 12, 2010, CI2 further reported that Respondent had added 
notes to CMI's fentanyl dispensing log. Id. The note indicated that 
Respondent had used two ampules of fentanyl on January 8, 2010. Id.
    On January 13, 2010, a criminal complaint was filed against 
Respondent, and on February 2, 2010, a grand jury indicted him on ten 
counts of intentionally and knowingly possessing with intent to 
distribute and unlawfully distributing fentanyl without a legitimate 
medical purpose on various dates in October and November 2009, in 
violation of 21 U.S.C. 841(a)(1), as well as six counts of obtaining 
morphine sulfate by misrepresentation, fraud, and deception in 
violation of 21 U.S.C. 843(a)(3). Declaration of S. Osborne, at 6; 
Indictment, United States v. Pellmann, No. 10-CR-014 (E.D. Wis., filed 
Feb. 2, 2010).
    Respondent was arrested after the filing of the criminal complaint. 
Following his release from custody, he travelled with J.E. to a 
Brookfield, Wisconsin hotel where he administered approximately two 
ampules of fentanyl to her during their stay. Declaration of S. 
Osborne, at 5. Thereafter, on the weekend of January 15-17, 2010, the 
two traveled to a Kohler, Wisconsin hotel, where Respondent 
administered midazolam, a schedule IV controlled substance,\4\ to J.E. 
several times so that she could ``detox'' from the Fentanyl. Id.

[[Page 17707]]

Respondent told J.E. not to mention the hotel visits to anyone. Id.
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    \4\ See 21 CFR 1308.14(c)(35).
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    The Investigative Record contains copies of prescriptions which 
Respondent issued for morphine sulfate and for fentanyl citrate ``for 
office use.'' The morphine sulfate prescriptions are dated April 23; 
May 6, 13, 14, 23, and 28; June 6, 16, 23, and 30; and July 6 and 14, 
2009. The fentanyl citrate prescriptions date back to August 2007 and 
extend through July 2009. Typically those prescriptions were for 
between 50 and 100 vials. However, the prescriptions of May 23 and June 
8, 2009 were for 200 vials each.
    Respondent went to trial; on June 4, 2010, a federal jury found him 
guilty of all sixteen counts alleged in the indictment. U.S. v. 
Pellmann, Verdict (June 4, 2010). After the return of the verdicts, the 
District Court allowed Respondent to remain free on bond on several 
conditions, including that he ``have `no contact whatsoever' '' with 
J.E. and that he ``not . . . `administer even to himself or anyone else 
any drugs whatsoever.' '' Aff. of E. Roy in Supp. of Mot. to Revoke 
Order of Release, U.S. v. Pellmann, at 1 (filed July 30, 2010).
    However, on July 29, 2010, an Assistant U.S. Attorney received a 
phone call from another confidential source who reported that a nurse 
at CMI had confronted Respondent after observing him near the narcotics 
box and that the nurse thereafter found missing five vials of 
midazolam. Id. Respondent told the nurse he was taking the midazolam to 
his other clinic in New Berlin. Id. This CS further stated that 
Respondent was continuing to treat J.E., that she was coming to the 
clinic, and also that Respondent was treating her at his house. Id.
    Shortly thereafter, a DI interviewed a CMI employee, who stated 
that the employee who performs CT scans at the clinic was called in on 
a Saturday by Respondent to do a CT scan of J.E. Aff. of E. Roy in 
Supp. of Mot. to Revoke Order of Release, at 2. The employee also 
stated that Respondent talked regularly about his contacts with J.E and 
stated that he was treating her for her pain and that the two had been 
staying together. Id.
    On July 29, 2010, the DI and other Investigators went to CMI. Id. 
at 2. Clinic employees stated that on July 23, 2010, the clinic had 
received ten boxes of midazolam, with each box containing ten vials for 
a total of 100 vials. Id. CMI's records showed that five vials had been 
administered to patients and that ten of the vials had been taken to 
Respondent's New Berlin office, supposedly at the request of a 
physician (Dr. Z.) who sublets space at that office and who is 
registered with DEA at both the Germantown clinic and the New Berlin 
office. Id. The DI counted the vials; the count matched the records at 
eighty-five vials. Id.
    Respondent was present during the July 29 visit. Id. Dr. Z. was not 
present, and, according to clinic staff, had not been there at all that 
day. Id. According to a clinic employee, Respondent had done at least 
one patient procedure prior to the Investigators' arrival during which 
he administered midazolam to the patient. Id. After noticing that the 
computerized office records did not reflect that Respondent had done 
so, the DI confronted Respondent. Id. at 2-3. Respondent admitted that 
he had, in fact, administered the midazolam, but claimed to have done 
so under Dr. Z.'s supervision. Id. at 3.
    That evening, the DI and other investigators went to the New Berlin 
office and met with Dr. Z. Id. at 3. Dr. Z. stated that the New Berlin 
office did not have any midazolam, that he had never requested 
Respondent to bring the drug to that office, and that he does not 
typically use midazolam there. Id. Moreover, he stated that he had not 
authorized Respondent to administer controlled substances during 
procedures. Id.
    The following morning, the CMI employee called the DIs and reported 
that after the DIs left the clinic, she had inspected the supposedly 
sealed boxes of midazolam. Id. She reported that the boxes appeared to 
have been tampered with and that some of the vials appeared to have 
been refilled and their tops re-glued. Id. Investigators then contacted 
Dr. Z. and gained his consent to seize all of the controlled substances 
at the Germantown clinic which had been procured using his DEA 
registration. Id. As the Investigators traveled to the clinic, the 
employee called again and stated that Respondent had just left the 
clinic with a bag containing drug vials. Id. Upon the Investigators' 
arrival, the employee told them that Respondent's sister had come to 
the clinic that morning and delivered ten vials of midazolam. Id. 
Respondent's sister claimed to have obtained the vials from the New 
Berlin office. Id.
    Clinic employees opened the controlled substances cabinet, and the 
Investigators counted the drugs. Id. at 4. The Investigators observed 
signs of tampering on five boxes of midazolam. They also found only 
fifty-five vials of the drug and concluded that forty vials were 
missing. Id.
    Thereafter, Respondent entered the clinic carrying a plastic 
shopping bag which contained thirty-six empty vials of midazolam. Id. 
Respondent claimed that he had gotten the vials out of the trash and 
that Dr. Z. had ``told him to `bring back the trash.' '' \5\ Id. The 
bag also contained Respondent's personal medication, a seven-day pill 
container, and some pharmacy pamphlets. Id.
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    \5\ To make clear, I do not find either statement credible.
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    Based on Respondent's having violated the conditions of release, on 
July 30, 2010, a United States District Judge issued an arrest warrant 
for Respondent. U.S. v. Pellmann, Arrest Warrant (July 30, 2010). 
Respondent was then arrested.
    As noted above, on June 7, 2010, Respondent's Counsel submitted 
Respondent's Statement of Facts and Position. Therein, Respondent 
maintained that ``all of the controlled substances he administered or 
dispensed to J.E. were for treatment of her pain related to Trigeminal 
Neuralgia'' and that treating J.E. ``required house calls given the 
nature of the pain and the time of her pain attacks.'' He further 
asserted that he discussed with J.E. ``her condition on a daily basis 
and he monitored her condition through daily interactions,'' and that 
``[h]e used several different pain medications, anti-inflammatory 
medication, and antibiotics in association with her pain caused by her 
Trigeminal Neuralgia and dental problems.'' He then asserted that all 
of the controlled substances he provided to J.E. ``were for a 
legitimate medical purpose.'' However, Respondent admitted that ``he 
did not maintain a proper inventory or records for the controlled 
substances dispensed within the scope of his practice.''

Discussion

    Section 304(a) of the Controlled Substances Act (CSA) provides that 
a ``registration pursuant to section 823 of this title to * * * 
dispense a controlled substance * * * may be suspended or revoked by 
the Attorney General upon a finding that the registrant * * * has 
committed such acts as would render his registration * * * inconsistent 
with the public interest as determined under such section.'' 21 U.S.C. 
824(a)(4). With respect to a practitioner's registration, the CSA 
directs that the following factors be considered in determining the 
public interest:
    (1) The recommendation of the appropriate State licensing board or 
professional disciplinary authority.
    (2) The applicant's experience in dispensing * * * controlled 
substances.
    (3) The applicant's conviction record under Federal or State laws 
relating to

[[Page 17708]]

the manufacture, distribution, or dispensing of controlled substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conducts which may threaten the public health and 
safety. 21 U.S.C. 823(f).\6\
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    \6\ Section 304(a)(2) further provides that a registration may 
be revoked ``upon a finding that the registrant * * * has been 
convicted of a felony under this subchapter [the CSA] * * * or any 
other law of the United States, or of any State, relating to any 
substance defined in this subchapter as a controlled substance.'' 21 
U.S.C. 824(a)(2).
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    ``[T]hese factors are * * * considered in the disjunctive.'' Robert 
A. Leslie, 68 FR 15227, 15230 (2003). I may rely on any one or a 
combination of factors and may give each factor the weight I deem 
appropriate in determining whether to revoke an existing registration 
or to deny an application. Id. Moreover, I am ``not required to make 
findings as to all of the factors.'' Hoxie v. DEA, 419 F.3d 477, 482 
(6th Cir. 2005); see also Morall v. DEA, 412 F.3d 165, 173-74 (DC Cir. 
2005).
    Having reviewed the Investigative Record, I conclude that the 
evidence relevant to factors two, four, and five establishes that 
Respondent has committed acts which render his registration 
inconsistent with the public interest. 21 U.S.C. 824(a)(4). 
Accordingly, Respondent's registration will be revoked and any pending 
application will be denied.

Factor One: The Recommendation of the Appropriate State Licensing 
Authority

    The record contains no evidence that the Wisconsin Medical 
Examining Board has made any recommendation to DEA regarding 
Respondent's registration. Therefore, I find that this factor neither 
weighs in favor of, or against, a finding that Respondent's continued 
registration is inconsistent with the public interest.

Factors Two and Four: Registrant's Experience in Dispensing Controlled 
Substances and Record of Compliance With Applicable Controlled 
Substance Laws

    Under a longstanding DEA regulation, a prescription for a 
controlled substance is not effective unless it is issued for a 
legitimate medical purpose by an individual practitioner acting in the 
usual course of his professional practice. 21 CFR 1306.04(a). This 
regulation further provides that an ``order purporting to be a 
prescription issued not in the usual course of professional treatment * 
* * is not a prescription within the meaning and intent of * * * 21 
U.S.C. 829 * * * and * * * the person issuing it, shall be subject to 
the penalties provided for violations of the provisions of law relating 
to controlled substances.'' Id. See also 21 U.S.C. 802(10) (Defining 
the term ``dispense'' as meaning ``to deliver a controlled substance to 
an ultimate user * * * by, or pursuant to the lawful order of, a 
practitioner, including the prescribing and administering of a 
controlled substance.'')
    As the Supreme Court recently explained, ``the prescription 
requirement * * * ensures patients use controlled substances under the 
supervision of a doctor so as to prevent addiction and recreational 
abuse. As a corollary, [it] also bars doctors from peddling to patients 
who crave the drugs for those prohibited uses.'' Gonzales v. Oregon, 
546 U.S. 243, 274 (2006) (citing United States v. Moore, 423 U.S. 122, 
135, 143 (1975)).
    Under Agency precedent, ``[i]t is fundamental that a practitioner 
must establish and maintain a bona-fide doctor-patient relationship in 
order to be acting `in the usual course of * * * professional practice' 
and to issue a prescription for a `legitimate medical purpose.' '' Paul 
H. Volkman, 73 FR 30630, 30642 (2008), aff'd sub nom. Volkman v. DEA, 
567 F.3d 215 (6th Cir. 2009) (citing United States v. Moore, 423 U.S. 
122, 142-43 (1975) (``noting that the evidence established that 
physician `exceeded the bounds of ``professional practice,' '' when `he 
gave inadequate physical examinations or none at all,' `ignored the 
results of the tests he did make,' and `took no precautions against * * 
* misuse and diversion.' '')).
    Wisconsin law likewise states that ``[a] practitioner may dispense 
or deliver a controlled substance to or for an individual * * * only 
for medical treatment * * * in the ordinary course of that 
practitioner's profession.'' Wis. Stat. Ann. Sec.  961.38. Wisconsin 
law also provides that ``[a]dministering, dispensing, prescribing, 
supplying, or obtaining controlled substances * * * otherwise than in 
the course of legitimate professional practice, or as otherwise 
prohibited by law'' is ``unprofessional conduct'' by a physician. Wis. 
Admin. Code [Med.] Sec.  10.02(2)(p).
    Respondent's experience in dispensing controlled substances and 
record of compliance with applicable laws is characterized by his 
numerous and brazen violations of multiple laws related to controlled 
substances. As found above, Respondent admitted that he administered 
and/or distributed to J.E. large quantities of fentanyl, a schedule II 
controlled substance; he also prescribed to J.E. other schedule II 
drugs such as oxycodone and morphine, as well as large quantities of 
Vicodin, a schedule III controlled substance containing hydrocodone. 
Moreover, Respondent frequently personally brought the drugs to J.E.'s 
residence.
    While in his Statement of Facts and Position, Respondent now 
asserts that he had a legitimate medical purpose in dispensing the 
controlled substances to J.E.; Respondent previously admitted in his 
November 10, 2009 interview that he did not have a medical chart 
documenting his treatment and medical purpose for administering and 
distributing controlled substances to her. Respondent's failure to 
maintain a medical chart on J.E. provides substantial evidence that he 
did not establish a legitimate doctor-patient relationship with her, a 
fact which is confirmed by his admission during the interview that his 
distribution of fentanyl and morphine to J.E. was not in the usual 
course of professional practice and that the situation between himself 
and J.E., with whom he likely had a sexual relationship, was not within 
the usual course of professional practice.\7\
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    \7\ Respondent admitted this in his interview during the 
execution of the search warrant at the Germantown clinic. While his 
counsel's letter of June 7, 2010 now maintains that J.E. had been 
his patient since 2005 and had been diagnosed as having Trigeminal 
Neuralgia, Respondent made no such contention in the November 2009 
interview and there is no medical record for J.E. documenting this. 
The absence of any patient file for J.E. confirms Respondent's 
admission in the interview that he did not distribute drugs to her 
in the course of professional practice.
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    During their respective November 2009 interviews, both Respondent 
and J.E. asserted that he provided the fentanyl to her to treat pain 
caused by a tooth which fractured in March 2009 and subsequently became 
infected. Notably, neither Respondent nor J.E. claimed that at any time 
after he determined the cause of her pain did he refer her to a 
dentist, who could have properly diagnosed her problem and treated it. 
Instead, he supplied her with an ever-increasing amount of fentanyl, a 
highly potent and abused narcotic.\8\ Such a gross departure from 
accepted standards of medical practice manifests that Respondent lacked 
a legitimate

[[Page 17709]]

medical purpose and acted outside of the usual course of professional 
practice when he dispensed fentanyl to J.E. 21 CFR 1306.04(a).
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    \8\ Even assuming that Respondent, a radiologist, has been 
trained in the proper use of the drug and the management of its 
respiratory effects, given that the injections took place at J.E.'s 
residence, it seems implausible that any of items which the package 
inserts warns should be readily available to counter fentanyl's 
respiratory depression effects such as an opioid agonist, 
resuscitative and intubation equipment, and oxygen were available. 
Finally, given the potency of this drug and the serious adverse 
reactions which it can cause, it does not seem that this is the type 
of drug that patients should be self-administering.
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    Finally, having been found guilty by a jury of all ten counts of 
unlawfully distributing fentanyl without a legitimate medical purpose 
in violation of 21 U.S.C. 841(a)(1), Respondent is collaterally 
estopped from re-litigating the issue of whether he had a legitimate 
medical purpose when he distributed fentanyl to J.E. Taylor v. 
Sturgell, 553 U.S. 880, 892 (2008) (citing New Hampshire v. Maine, 532 
U.S. 742, 748-49 (2001)). I therefore reject Respondent's contention 
that he had a legitimate medical purpose for providing fentanyl to J.E.
    While Respondent admitted in the November 2009 interview that he 
knew J.E. was addicted to fentanyl, he continued to provide fentanyl to 
her even after she began receiving treatment for her addiction. Indeed, 
he continued to administer controlled substances to J.E. even after he 
had been criminally charged and arrested. More specifically, in January 
2010, he administered fentanyl to her at a Brookfield, Wisconsin hotel 
room; several days later, the two checked in to a Kohler, Wisconsin 
hotel room where he gave J.E. midazolam to detox her from the fentanyl. 
The evidence therefore shows that Respondent repeatedly violated the 
CSA by unlawfully distributing controlled substances to J.E. See 21 
U.S.C. 841(a)(1) (``[e]xcept as authorized by this subchapter, it shall 
be unlawful for any person knowingly or intentionally * * * to 
manufacture, distribute, or dispense, or possess with intent to 
manufacture, distribute, or dispense, a controlled substance''); see 
Michael F. Myers, 72 FR 36484, 36486 (2007) (revoking physician's 
registration where physician, inter alia, continued to prescribe 
OxyContin to a ``patient'' notwithstanding the ``patient's'' informing 
physician that he was addicted to the drug).
    Respondent further violated Federal law when he obtained controlled 
substances by fraud. See 21 U.S.C. 843(a)(3) (``It shall be unlawful 
for any person knowingly or intentionally * * * to acquire or obtain 
possession of a controlled substance by misrepresentation, fraud, 
forgery, deception, or subterfuge [.]''). As found above, Respondent 
wrote numerous prescriptions for fentanyl and morphine sulfate to 
obtain these drugs from local pharmacies; while Respondent noted on the 
prescriptions that the controlled substances were ``for office use,'' 
the evidence shows that only a miniscule portion of the fentanyl (427 
ampules out of more than 4,100 ampules obtained in this manner) was 
used for medical procedures at the clinic and that the vast majority of 
the fentanyl was being provided to J.E.
    As for the morphine, the evidence showed that Respondent obtained 
more than 2,000 dosage units from a local pharmacy. However, 
Respondent's clinic did not use this drug in any procedures. Rather, 
Respondent both self-administered the morphine and distributed it to 
J.E. It is thus clear that by representing that the fentanyl and 
morphine were ``for office use,'' Respondent obtained the drugs by 
fraud and deception.\9\ 21 U.S.C. 843(a)(3). See Randall Relyea, 73 FR 
40378, 40380 (2008) (revoking physician's registration based on 
violations of section 843(a)(3) and physician's personal abuse of 
controlled substances thus obtained); Alan H. Olefsky, 72 FR 42127, 
42128 (2007) (denying application based on physician's violations of 
section 843(a)(3) and personal abuse of controlled substances thus 
obtained). Relatedly, DEA regulations prohibit the use of a 
prescription by ``an individual practitioner to obtain controlled 
substances for supplying the * * * practitioner for the purpose of 
general dispensing to patients.'' 21 CFR 1306.04(b).
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    \9\ Under Federal law, to obtain schedule II controlled 
substances, a DEA Form 222 must be completed and sent to the 
distributor. See 21 U.S.C. 828(c)(2). This applies even where a 
practitioner obtains a schedule II controlled substance from a 
pharmacy. 21 CFR 1307.11(a)(1)(iii). It is unclear whether 
Respondent ever submitted DEA Form 222s to the pharmacies he 
obtained schedule II drugs from. However, the Government has the 
burden of proof on the issue.
     As for the morphine and fentanyl he obtained from distributors, 
Federal law makes it ``unlawful for any person to obtain by means of 
order forms * * * controlled substances for any purpose other than 
their use, distribution, dispensing, or administration in the 
conduct of a lawful business in such substances or in the course of 
his professional practice.'' 21 U.S.C. 828(e) (emphasis added). 
Thus, Respondent's obtaining of fentanyl and morphine from various 
distributors was also illegal.
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    Wisconsin law prohibits a practitioner from ``tak[ing] without a 
prescription a controlled substance * * * for the practitioner's own 
use.'' Wis. Stat. Ann. Sec.  961.38(5). Because Respondent did not 
obtain the morphine pursuant to a prescription from a physician, he 
violated Wisconsin law when he used the morphine. He likewise violated 
the CSA, which renders it ``unlawful for any person knowingly or 
intentionally to possess a controlled substance unless such substance 
was obtained directly, or pursuant to a valid prescription or order, 
from a practitioner, while acting in the course of his professional 
practice.'' 21 U.S.C. 844(a).
    Respondent further violated both the CSA and DEA regulations by 
failing to maintain proper records. As found above, during the search 
of the clinic, there were neither initial inventories nor biennial 
inventories, dispensing logs were missing for several months, and the 
dispensing logs that were available were clearly not being properly 
maintained as demonstrated by the audits which could not account for 
more than 10,000 dosage units of fentanyl and more than 3,000 dosage 
units of morphine. See 21 U.S.C. 827(a); 21 CFR 1304.03(a), 1304.11, 
and 1304.22(c). Respondent also admitted that he had failed to maintain 
the lawfully required records. Even were there no other evidence of 
Respondent's unlawful conduct, his failure to comply with his 
recordkeeping obligations is so egregious that it alone would support 
the revocation of his registration.
    As the foregoing demonstrates, Respondent's experience in 
dispensing controlled substances and his record of compliance with 
applicable laws related to the distribution and dispensing of 
controlled substance are characterized by his repeated and flagrant 
disregard for Federal and State laws. This evidence clearly supports 
the conclusion that Respondent has committed acts which render his 
registration inconsistent with the public interest.\10\
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    \10\ As found above, on June 4, 2010, a jury found Respondent 
guilty of ten counts of violating 21 U.S.C. 841(a)(1) and six counts 
of violating 21 U.S.C. 843(a)(3), both of which are felony offenses. 
The record does not, however, include a copy of the judgment of 
conviction entered by the District Court.
     Factor three authorizes the Agency to consider a registrant's 
conviction record under Federal or State laws related to the 
distribution or dispensing of controlled substances. See 21 U.S.C. 
823(f)(3); see also 21 U.S.C. 824(a)(2) (authorizing revocation 
where registrant ``has been convicted of felony under this 
subchapter''). However, in light of the substantial misconduct 
proved on this record, it is unnecessary to determine whether the 
term ``conviction'' as used in factor 3 and section 304(a)(2) means 
a judgment of conviction or simply a finding of guilty which 
precedes the entry of a final judgment of conviction. See Deal v. 
United States, 508 U.S. 129, 131 (1993). I therefore make no 
findings on this factor.
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Factor Five--Such Other Conduct Which May Threaten Public Health and 
Safety Offenses

    On January 29, 2010, Respondent's registration was immediately 
suspended because his misconduct created an imminent danger to public 
health and safety. As a consequence of the Order, which was served on 
him on February 2, Respondent was prohibited from possessing controlled 
substances (other than those he obtained through a legal prescription) 
and dispensing them.

[[Page 17710]]

Notwithstanding the Order (as well as that of the District Court 
following the jury verdicts which allowed him to remain free on bond on 
the condition that he not administer any drugs either to himself or 
others), in July 2010, Respondent proceeded to possess midazolam, a 
schedule IV controlled substance, and he admitted to administering the 
drug to a patient. While Respondent claimed that he had administered 
the midazolam under the supervision of another physician, the latter 
physician stated that he had not authorized Respondent to administer 
any controlled substances.
    The next day, Investigators received a report from a clinic 
employee that boxes containing midazolam had been tampered with. Later 
that day, Investigators went to the clinic and determined that forty 
vials of midazolam were missing; thereafter, Respondent entered the 
clinic and had in his possession thirty-six vials which had contained 
the drug.\11\ This evidence supports the conclusion that Respondent 
possessed these additional amounts of midazolam in violation of the 
Immediate Suspension Order.
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    \11\ To make clear, Respondent did not have a prescription for 
midazolam.
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    Respondent's violation of the Order (as well as the conditions 
imposed by the District Court) is egregious and demonstrates that he 
has no respect for the laws governing the distribution and dispensing 
of controlled substances and the authority of this Agency and the 
Courts. This factor buttresses the conclusion that Respondent has 
committed acts which render his registration inconsistent with the 
public interest and that his registration should be revoked. For the 
same reason which led me to order the immediate suspension of his 
registration, I conclude that this Order should be effective 
immediately.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) & 
824(a)(4), as well as 28 CFR 0.100(b) & 0.104, I order that DEA 
Certificate of Registration, AP1892822, issued to Roger A. Pellmann, 
M.D., be, and it hereby is, revoked. I further order that any 
application of Roger A. Pellmann, M.D., to renew or modify his 
registration be, and it hereby is, denied. This order is effective 
immediately.

    Dated: March 22, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-7411 Filed 3-29-11; 8:45 am]
BILLING CODE 4410-09-P