Registrant Actions - 2011
[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]
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
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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