[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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\4\ Eventually another physician terminated N.G. from the
clinic's practice.
---------------------------------------------------------------------------
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]
BILLING CODE 4410-09-P