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Randi M. Germaine, M.D.; Revocation of Registration
FR Doc E7-17757 [Federal Register: September 10, 2007 (Volume 72,
Number 174)] [Notices] [Page 51665-51668] From the Federal Register
Online via GPO Access [wais.access.gpo.gov] [DOCID:fr10se07-79]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Randi M. Germaine, M.D.; Revocation of Registration
On December 14, 2006, the Deputy Assistant Administrator, Office of
Diversion Control, issued an Order to Show Cause to Randi M. Germaine,
M.D. (Respondent), of Casa Grande, Arizona. The Show Cause Order
proposed the revocation of Respondent's DEA Certificate of Registration,
BG3717278, as a practitioner, as well as the denial of any pending
applications for renewal or modification of the registration, on the
ground that his continued registration is inconsistent with the public
interest. Show Cause Order at 1.
The Show Cause Order specifically alleged that during the execution
of a search warrant at the Morenci Healthcare Center (Respondent's
former employer), copies of patient charts were obtained which were then
sent to a medical expert for review. Id. at 2. The Show Cause Order
alleged that the expert had concluded that Respondent's
"prescribing practices concerning controlled substances did not
meet the usual standard of care.'' Id. Relatedly, the Show Cause Order
alleged that background checks on some of Respondent's patients
indicated that they "were receiving excessive and unnecessary
amounts of controlled substances,'' that they were known to law
enforcement to be "drug abusers,'' and that some of them had
committed controlled- substance offenses. Id. Relatedly, the Show Cause
Order alleged that some of Respondent's patients "were known to
area pharmacists as `doctor shoppers' and `chronic early refillers.' ''
Id. Moreover, "a number of [Respondent's] patients were family
members receiving the same prescriptions for controlled substances.''
Id.
The Show Cause Order further alleged that the "autopsy reports
for two of [Respondent's] patients * * * showed [that] the cause of
death [was] drug overdoses resulting from controlled substances
prescribed by'' Respondent. Id. The Show Cause Order also alleged that
another of Respondent's patients had "died after obtaining invalid
prescriptions from [him] for controlled substances.'' Id.
On January 8, 2007, the Show Cause Order, which also notified
Respondent of his right to a hearing, was served on him as evidenced by
the signed return-receipt card. Because (1) More than thirty days have
passed since service of the Show Cause Order, and (2) Respondent did not
timely request a hearing, I conclude that Respondent has waived his
right to a hearing. See 21 CFR 1309.53(c). I therefore enter this Final
Order without a hearing based on relevant material found in the
investigative file and make the following findings.
Findings
Respondent is the holder of DEA Certificate of Registration,
BG3717278, which authorizes him to handle controlled substances as a
practitioner at the registered location of Harvest Medical Clinic, Inc.,
1856 E. Florence Blvd., Casa Grande, Arizona. Respondent's registration
does not expire until September 30, 2008.
On August 25, 2003, the Greenlee County Sheriff's Office contacted
the DEA Tucson Diversion Group regarding Respondent's termination from
the Morenci Healthcare Center based on the allegation that he over-
prescribed narcotic controlled substances. The Sheriff's Office also
informed DEA Investigators that R.S., a thirty-one year old male inmate
at the county jail and patient of Respondent, had died and that the
autopsy report had found both methadone and benzodiazepines in his
blood. While the autopsy report noted that the cause of death could not
be determined and that the "[t]oxicology findings may be equivocal
due to decomposition,'' R.S. was known to local law enforcement as a
drug abuser. The Sheriff's Office further related that Respondent had
prescribed methadone (10 mg. tablets) for R.S. for back pain.
Subsequently, R.S.'s medical records were sent to Ted Parran, M.D., a
board-certified internist and Associate Clinical Professor of Medicine
and Family Medicine at the Case Western Reserve University School of
Medicine and Director of its Addiction Fellowship Programs.\1\ According
to Dr. Parran's report (hereinafter, Expert Report), R.S. died four days
after Respondent started him on methadone and "had demonstrated
much drug seeking behavior over the past two years.'' Expert Report at
2. Dr. Parran noted that R.S. "had [a]n MRI scanning demonstrating
little pathology, had longstanding complaints and office behavior out of
proportion to evidence of illness, and [a history] of non-compliance
with [physical therapy] referrals.'' Id. Dr. Parran further noted that
R.S. "had been pretty much off of opioid analgesics (except for a
few Vicodin or Percocet) and in [j]ail for a while when for some reason
he was started on [m]ethadone * * * on 5/30/ 02.'' Id. Dr. Parran
concluded that "[t]his prescribing is difficult to imagine, fails
to meet usual standards of care and concern when prescribing controlled
drugs, appears to be for other than [a] legitimate medical purpose, and
appears to have played a direct role in the patient's death.'' Id.
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\1\ Dr. Parran has also performed research and
issued written educational materials on addiction and
controlled-substance prescribing. He has also developed a remedial
education course on controlled-substance prescribing.
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On or about May 31, 2003, D.K., a twenty-five year old female and
another of Respondent's patients, died of a drug overdose. According to
the toxicology report, hydrocodone, oxycodone, diazepam, and nordiazepam
were present in D.K.'s blood. Furthermore, the examining pathologist
found that
[[Page 51666]]
D.K.'s death "is due to an acute intoxication due to the
combined effects of multiple prescription medications including
hydrocodone and oxycodone.''
Upon review of D.K.'s chart, Dr. Parran found "much evidence of
out of control behavior.'' Expert Report at 5. More specifically, Dr.
Parran noted that D.K. had lied about her "drug use''; that there
was "[c]lear evidence'' that on three occasions D.K. was "Dr.
shopping'' and that on four other occasions she engaged in "scams''
to obtain additional drugs; that her medical complaints bore "no
resemblance to the physical exam''; that there were "multiple
multiple early refill attempts''; and that approximately five months
before her death, another physician had diagnosed her with bipolar
disorder and determined that she "need[ed] to be tapered off of all
controlled drugs.'' Id. at 5-6.
Dr. Parran also noted another visit in which Respondent had noted
that D.K. was "worried about Hep[atitis] C and HIV * * * needle
stick exposure--sharing needles,'' and that she needed a urine drug
screen. Id. at 5. Dr. Parran observed that Respondent nonetheless issued
D.K. a prescription for Vicodin for "acute pain and cough.'' Id.
Dr. Parran also found that D.K. had not been prescribed controlled
substances between January and May 9, 2003, the latter being the date
when Respondent "began the prescribing that ultimately contributed
to [D.K.'s] death.'' Id. at 6. Dr. Parran noted that Respondent issued
prescriptions to D.K. on May 9, 2003 for 90 hydrocodone; on May 20,
2003, for another 90 hydrocodone; and on May 27, 2003, for 40 Percocet (oxycodone).\2\
Id. On May 28, 2003, D.K. overdosed and died three days later. Id. Based
on his review, Dr. Parran concluded that Respondent's prescribing of
controlled substances "fails to meet usual standards of care,
appears to be for other than legitimate medical purpose and appears to
have contributed directly to the patient's death.'' Id.
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\2\ According to the investigative file, D.K.'s
chart contained a notation indicating that only her OB/GYN, who was
treating her for pain related to a minor surgical procedure, could
prescribe controlled substances to her. D.K.'s OB/GYN further told
investigators that there was no medical reason why D.K. should have
been prescribed controlled substances after April 30, 2003.
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On July 31, 2003, S.B., a fifty-six year old female patient of
Respondent, also died of a drug overdose. The toxicology report noted
that propoxyphene, norproxyphene, and nordiazaepam were present in her
blood; the pathologist concluded that S.B.'s death was "due to an
acute multidrug intoxication including * * * Propoxyphene.''
DEA investigators subsequently determined that between August 5,
2002, and July 21, 2003, Respondent prescribed for S.B. numerous
controlled substances. More specifically, he prescribed 5520
propoxyphene capsules, 1200 hydrocodone (7.5/500 mg.) tablets, 729
Oxycontin tablets in various strengths, 21 flurazepam (both 15 mg. and
30 mg. strength) tablets, 150 lorazepam (1 mg.) tablets, 90 oxycodone (5
mg.) tablets, and 10 Duragesic (75 mcg.) patches.
Dr. Parran's review noted that S.B. "was a longstanding patient
of the Health Center, with many medical problems including arthritis and
headaches, and with a warning note on the front of the chart * * * to
`avoid all narcotics.' '' Expert Report at 3. Dr. Parran further found
that "from the first time [Respondent] saw this patient [he] began
adding controlled drugs'' including Vicodin, Darvocet, Fiorinal,
Tussionex, Oxycontin, Darvon, Ativan (lorazepam), and flurazepam. Id.
Dr. Parran further noted that Respondent had engaged in "an
additional flurry of prescribing'' during the period of March and April
2003. Id. Specifically, he noted that Respondent prescribed Oxycontin
(40 mg.) on March 20th, Darvocet on April 1st, Vicodin on April 11th,
multiple strengths of Oxycontin on April 14th, Vicodin and Oxycontin
again on April 21st, and both flurazepam with two refills and a
Duragesic (fentanyl) patch on April 28th. Id. Dr. Parran further found
that "in a six month period [Respondent] prescribed 3700 tablets of
opioids and additional benzodiazepines and barbiturates.'' Id. Dr.
Parran concluded that "[t]his escalating prescribing of controlled
drugs to a drug seeking patient who was clearly out of control with her
use fails to meet usual standards of care, appears to be for other than
[a] legitimate medical purpose and appears to have contributed to the
patient's death.''\3\ Id.
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\3\ Following the death of S.B., Respondent's former
employer reported Respondent to the Arizona Medical Board. The Board
subsequently concluded that Respondent had committed unprofessional
conduct under Ariz. Rev. Stat. Sec. 32-1401(27)(q). The Board ordered
that Respondent be issued a letter of reprimand for excessive
prescribing and be placed on probation. The Board's decision focused
entirely on Respondent's treatment of S.B. and did not discuss his
prescribing practices with respect to any other patient. See In re
Randi M. Germaine, M.D. (Ariz. Med. Bd. Aug. 12, 2005) (Case
MD-03-0897A).
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Dr. Parran also reviewed Respondent's prescribing with respect to a
fourth patient, N.G. Between October 31, 2002, and April 10, 2003,
Respondent prescribed for N.G., 1418 methadone (10 mg.) tablets, 605
oxycodone (5 mg.) tablets, and 120 hydrocodone (7.5/750 mg.) tablets.
According to Dr. Parran, this "patient demonstrated Dr. shopping
behavior over a long period of time.'' Expert Report at 4. Moreover,
based on a December 12, 2002 toxicology screening, another physician at
the clinic had indicated that N.G. had violated her controlled-
substance contract. Id. Respondent nonetheless continued to prescribe
controlled substances to her. Id.
Dr. Parran further noted that N.G.'s chart indicated that she had
engaged in several scams to obtain additional controlled substances
including going to the emergency room, and claiming either that she had
run out early or that her drugs had been stolen. Id. Moreover,
notwithstanding that her chart included: (1) A pharmacy use printout
showing that N.G. was engaged in the "tremendous over-use of
controlled drugs,'' (2) "an extensive note'' from another physician
"indicating that she should get no more controlled drugs from the
practice,'' and (3) a March 2003 note from another clinic (that N.G. had
been referred to) which diagnosed her as a drug abuser and recommended
that she be "wean[ed] off of narcotics,'' Respondent continued to
prescribe controlled substances to her. Id. Indeed, three days after N.G.
had again gone to the emergency room trying to get early medications,
Respondent again prescribed controlled substances to her.\4\ Id.
According to Dr. Parran, "[t]his continued prescribing of
controlled drugs to a patient who was non-compliant with the treatment
plan and clearly out of control with her use fails to meet usual
standards of care and appears to be for other than [a] legitimate
medical purpose.'' Id.
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\4\ Eventually another physician terminated N.G.
from the clinic's practice.
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According to Dr. Parran, another of Respondent's patients (D.J.), had
"demonstrated multiple behaviors that alerted the practice to her
problems with controlled drugs including early calls, early visits,
claiming [she was going] `out of town' for early scripts'' but
"then keeping the original appointments.'' Id. at 7. Moreover,
notwithstanding that: (1) D.J. had broken her controlled substance
contract; (2) that another physician had recently indicated that D.J.
should no longer be prescribed controlled substances; and (3) that
Respondent had himself indicated that D.J.'s toxicology test results
were abnormal, that she was engaged in doctor shopping, and that
[[Page 51667]]
controlled drugs should be discontinued; two months later, Respondent
gave D.J. a prescription for Vicodin. Id. at 7-8. Respondent then
proceeded to issue D.J. numerous other prescriptions including several
early prescriptions and one based on her representation that she was
going out of town. Id. at 8. According to Dr. Parran, Respondent's
"continued prescribing of controlled drugs to a patient who was
non- compliant and clearly out of control with her use fails to meet
usual standards of care and appears to be for other than [a] legitimate
medical purpose.''' Id.
Discussion
Section 304(a) of the Controlled Substances Act provides that a
registration 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 under section 823 of this title inconsistent with the
public interest as determined under such section.'' 21
U.S.C. 824(a)(4). With respect to a practitioner, the Act requires
the consideration of the following factors in making the public interest
determination:
(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 the manufacture, distribution, or dispensing of controlled
substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
Id.
"[T]hese factors are * * * considered in the disjunctive.''
Robert A. Leslie, M.D., 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 a registration should be
revoked.'' Id. Moreover, case law establishes that 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 (D.C. Cir. 2005).
In this matter, I acknowledge that the Arizona Medical Board has not
revoked Respondent's state license. The Board's inquiry was, however,
limited to Respondent's prescribing to a single patient. Therefore, I
decline to defer to the Board's decision and conclude that Respondent's
experience in dispensing controlled substances and his record of
non-compliance with Federal law and regulations demonstrate that his
continued registration is "inconsistent with the public interest.''
21 U.S.C. 823(f).
Factors Two and Four--Respondent's Experience in Dispensing
Controlled Substances and Record of Compliance With Applicable Laws
Relating to Controlled Substances
Under DEA regulations, 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 related to
controlled substances.'' Id. 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, 126 S.Ct. 904, 925 (2006) (citing Moore, 423 U.S.
122, 135 (1975)).
As found above, Dr. Parran, an expert on the prescribing of
controlled substances, reviewed the medical records of patients treated
by Respondent including several who had overdosed on controlled
substances. Dr. Parran specifically noted that Respondent prescribed
controlled substances to patients notwithstanding that they were engaged
in drug-seeking behaviors including doctor shopping and various scams
used to obtain additional prescriptions.
Moreover, Dr. Parran found in multiple instances that Respondent's
prescriptions were not issued for a legitimate medical purpose. With
respect to R.S., Dr. Parran found that Respondent's "prescribing is
difficult to imagine, * * * appears to be for other than [a] legitimate
medical purpose, and appears to have played a direct role in the
patient's death.'' Expert Report at 2.
In regards to D.K., Dr. Parran noted that she too was engaged in
doctor shopping and other scams such as early refill attempts and
medical complaints that were not confirmed by a physical exam. Moreover,
her chart included a notation that only her OB/GYN could prescribe
controlled substances for her; her OB/GYN told investigators that after
April 30, 2003, there was no medical reason why she should have been
prescribed controlled substances. Nonetheless, on May 9 and 20, 2003,
Respondent prescribed for D.K. drugs containing hydrocodone, and on May
27, 2003, Respondent prescribed Percocet (oxycodone). D.K. overdosed the
next day. Based on his review, Dr. Parran concluded that Respondent's
prescribing of controlled substances for D.K. "appears to be for
other than [a] legitimate medical purpose and appears to have
contributed directly to [her] death.'' Id. at 6.
S.B. was another patient of Respondent who died of an overdose. With
respect to her, Dr. Parran found that notwithstanding that her chart
included a warning note to "avoid all narcotics,'' Respondent
prescribed controlled drugs including various opiates including Vicodin,
Darvocet, Tussionex, Oxycontin, and Darvon. In addition, Respondent
prescribed other controlled substances including benzodiazepines and
barbiturates. Dr. Parran further found that in a six month period,
Respondent prescribed 3,700 tablets of opioids (as well as drugs in
other categories of controlled substances). Dr. Parran concluded that
"[t]his escalating prescribing of controlled drugs to a drug
seeking patient who was clearly out of control with her use * * *
appears to be for other than [a] legitimate medical purpose and appears
to have contributed to the patient's death.'' Id. at 3.
In sum, Dr. Parran's findings provide ample support for the
conclusion that Respondent was not issuing prescriptions for "a
legitimate medical purpose,'' 21 CFR 1306.04(a), but rather, was
"peddling to patients who crave the drugs for * * * prohibited
uses.'' Gonzales v. Oregon, 126 S.Ct. 904, 925 (2006) (citing Moore, 423
U.S. 122, 135 (1975)). Accordingly, I find that Respondent's experience
in dispensing controlled substances is characterized by repeated
violations of the CSA. I therefore conclude that Respondent's continued
registration is "inconsistent with the public interest.'' 21
U.S.C. 823(f). Moreover, I further find that the public safety
requires that this Order be effective immediately. 21
CFR 1316.67.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) & 824(a),
as well as 28 CFR 0.100(b) & 0.104, I hereby order that DEA
Certificate Registration, BG3717278, issued to Randi M.
[[Page 51668]]
Germaine, M.D., be, and it hereby is, revoked. I further order that
any pending applications for renewal or modification of his registration
be, and they hereby are, denied. This order is effective immediately.
Dated: August 30, 2007.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E7-17757 Filed 9-7-07; 8:45 am]
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