[Federal Register: November 29, 2002 (Volume 67, Number 230)]
[Notices]
[Page 71198-71202]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29no02-124]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Joseph H. Talley, M.D.; Revocation of Registration
On January 28, 2002, the Administrator of the Drug Enforcement
Administration (DEA), issued an Order to Show Cause and Notice of
Immediate suspension of Registration to Joseph H. Talley, M.D.
(Respondent) of Grover, North Carolina. The Respondent was notified of
an opportunity to show cause as to why DEA should not revoke his DEA
Certificate of Registration AT2853706, as a practitioner, and deny any
pending applications for renewal of such registration pursuant to 21
U.S.C. 823(f) and 824(a) for reason that his continued registration
would be inconsistent with the public interest. The order further
notified the Respondent that his DEA registration was immediately
suspended as an imminent danger to the public health and safety
pursuant to 21 U.S.C. 824(d).
The order to Show Cause and Notice of Immediate Suspension alleged
the following:
1. (The Respondent) is registered with DEA as a practitioner under
DEA Registration No. AT2853706 for Schedules II, II-N, III, III-N, IV
and V. The DEA registration was last renewed
[[Page 71199]]
on November 13, 2000. The registered location is PO Box 45, 318 Laurel
Avenue, Grover, NC 28073.
2. (The Respondent) regularly engaged in the practice of
prescribing excessive amounts of controlled substances, including
combinations of Schedule II and III controlled substances such as
OxyContin (II), Methodone (II) and Hydrocodone (III), along with a
benzodiazepine such as Alprazolam (IV), to patients for no legitimate
medical reason. (The Respondent's) patients have been associated with
drug trafficking and drug abuse, and numerous patients have died due to
drug overdose. The North Carolina Medical Board has filed charges
alleging, in part, that (the Respondent's) practice of dispensing
controlled substances falls below acceptable standards of care.
Finally, (the Respondent has) circumvented DEA regulations by, in
effect, post-dating Schedule II controlled substance prescriptions and
maintaining at (his) registered location controlled substances that
allegedly were returned to (the Respondent) by (his) patients.
3. During an interview with North Carolina investigators on March
13, 2001, (the Respondent) stated that (his) normal prescribing
practice is to use at least two (2) opiates along with antidepressants,
and that (he uses) Xanax and Klonopin because Xanax is short acting and
Klonopin lasts longer. (The Respondent) also said that modern pain
management calls for maintaining a level of drugs in the patient's
system all the time, and at least 50 percent pain-related patients also
suffer from anxiety and depression.
4. (The Respondent's) patients routinely received minimal or no
medical examinations prior to receiving controlled substance
prescriptions. Some of these patients were out-of-state patients who
were treated after telephone consultations. (The Respondent has)
numerous patients who are out-of-state patients from states including
Tennessee, South Carolina, Georgia, Oklahoma, California, Wisconsin,
Missouri, Rhode Island, New Jersey, New York, Louisiana, Florida and
Alabama. Most of these patients were interviewed over the telephone
rather than seen in person. The patients describe their symptoms during
a telephone call every three months and receive prescriptions for
controlled substances.
5. DEA obtained the prescription profiles of mail order customers
of Medi Fare Drug Center, 100 Laurel Avenue, PO Box 309, Grover, NC
28073. The profiles revealed that approximately 60 customers were (the
Respondent's) patients who lived in north central South Carolina, an
hour or so distance from Grover, NC. Many of these patients received
excessive amounts, in combination, of the following controlled
substances: Morphine Sulfate (Schedule II), Methadone (Schedule II),
Oxycodone (Schedule II), Hydromorphone (Schedule II), Hydrocodone
(Schedule (III), Hydromorphone (Schedule II), Hydrocodone (Schedule
III), Alprazolam (Schedule IV), Diazepam (Schedule IV), and/or Ambien
(Schedule IV).
6. For instance, the prescription profiles of the following mail
order customers revealed that:
A. Patient Sally B. received prescriptions for, among other things:
Date and Medication
3/13/00
248 Hydrocodone/APAP 10-650
93 Alprazolam 2 mg
90 Methylphenidate 20 mg [Ritalin]
3/28/00
250 OxyContin 80 mg
360 Percocet 10/650
4/14/00
248 Hydrocodone/APAP 10-500
93 Alprazolam 2 mg
4/26/00
248 OxyContin 80 mg
93 Alprazolam 2 mg
5/24/00
279 OxyContin 80 mg
93 Alprazolam 2 mg
90 Methylphenidate 20 mg
6/20/00
279 OxyContin 80 mg
93 Alprazolam 2 mg
360 Percocet 10-650
93 Lipitor 40 mg
7/19/00
279 OxyContin 80 mg
93 Alprazolam 2 mg
7/21/00
90 Prozac 20 mg
31 Furosemide 40 mg
B. Patient Debra M. received prescriptions for, among other things:
Date and Medication
5/1/00
155 OxyContin 80 mg
100 Oxycodone 5-500
93 Alprazolam 2 mg
30 Diazepam 10 mg
6/1/00
155 OxyContin 80 mg
100 Ocycodone 5-500
93 Alprazolam 2 mg
30 Diazepam 10 mg
C. Patient George N. received prescriptions for, among other
things:
Date and Medication
5/10/00
186 Hydrocodone/APAP 10-500
136 Alprazolam 2 mg
120 carisoprodol 350 mg
62 Prozac 20 mg
6/5/00
186 Hydrocodone/APAP 10-500
136 Alprazolam 2 mg
120 carisoprodol 350 mg
62 Prozac 20 mg
47 Remeron 30 mg
7/5/00
186 Hydrocodone/APAP 10-500
136 Alprazolam 2 mg
120 carisoprodol 350 mg
D. Patient James W. received prescriptions for, among other things:
Date and Medication
4/18/00
186 OxyContin 80 mg
124 Hydromorphone 4 mg
60 Promethazine 50 mg
5/17/00
186 OxyContin 80 mg
124 Hydromorphone 4 mg
60 Promethazine 50 mg
E. Patient Debra C. received prescriptions for, among other things:
Date and Medication
6/7/00
124 Hydrocodone/APAP 10-500
124 Alprazolam 2 mg
31 Trazodone 100 mg
124 Carisoprodol 350 mg
6/8/00
36 Dilaudid 3 mg
124 MS CP 60 mg
7/7/00
124 Hydrocodone/APAP 10-500
124 Alprazolam 2 mg
31 Trazodone 100 mg
124 Carisoprodol 350 mg
36 Dilaudid 3 mg
124 MS S.R. CP 60 mg
F. Patient Charles K. received prescriptions for, among other
things:
Date and Medication
4/3/00
248 Hydrocodone/APAP 10-500
93 Methadose 40 mg
62 Alprazolam 2 mg
5/3/00
248 Hydrocodone/APAP 10-500
93 Metadose 40 mg
62 Alprazolam 2 mg
6/2/00
248 Hydrocodone/APAP 10-500
93 Methadone 40 mg
62 Alprazolam 2 mg
6/30/00
248 Hydrocodone/APAP 10-500
93 Methadone 40 mg
62 Alprazolam 2 mg (RX 313579)
62 Alprazolam 2 mg (RX 313574)
7. (The Respondent's) patients have been observed in (his) office
discussing what prescriptions they would obtain from (him) and what
they planned to do with the medication after obtaining it.
[[Page 71200]]
Patients also have been observed selling controlled substances in the
parking lot outside of (the Respondent's) medical office.
8. (The Respondent's) patients have been implicated in drug dealing
activities. For instance, (the Respondent) prescribed OxyContin for
(his) patient, Debra M, who was known to trade her OxyContin for
Methadone tablets. She also sold OxyContin for the following prices:
OxyContin 160 mg--$40/tab OxyContin 40 mg--$10/tab
OxyContin 80 mg--$20/tab OxyContin 20 mg--$5/tab
9. (The Respondent has) two patients who are husband and wife,
Jerry C. and Carol C., both of whom are engaged in the abuse of
Methadone. (The Respondent) continued to prescribe Methadone to them
even though (he) knew or had reason to know that Jerry C. and Carol C.
were abusing Methadone. When she rolled up her sleeves, Carol C.'s arms
were covered with sores and her veins displayed huge knots consistent
with drug abuse. Despite being informed that Jerry C. and Carol C. both
admitted to drug abuse, (The Respondent) continued to write controlled
substance prescriptions for them.
10. (The Respondent has) written controlled substance prescriptions
for pregnant women and told them that taking narcotics would not harm
their newborn babies. The newborn baby of one of (the Respondent's)
former patients, Alice P., was born addicted to Methadone.
11. On May 14, 1999, (the Respondent) contacted the Spartanburg
County, SC, Coroner's Office and spoke to (a representative from that
office) regarding the death of Darrell S. During that conversation,
(the Respondent) stated that the Spartanburg Co. Coroner's Office would
be seeing (the Respondent's) name and the name of (his) clinic more
often because doctors in Spartanburg would not give ``these people''
the medications that they needed, and sometimes (the Respondent)
lose(s) some.
12. At least 23 of (the Respondent's) former patients have died, in
part, due to drug overdoses.
13. On June 6, 2001, patient Teresa B., died of a drug overdose.
(The Respondent) saw her as a patient on or about the day of her death
and (he) issued her a prescription for controlled substances, including
but not limited to Methadone. Teresa B. was known to receive a
prescription for more than 100 Methadone tablets per month. During the
evening hours of the date in which Teresa B. died, another one of (the
Respondent's) patients, Debra M., visited the residence of Teresa B.,
for the purpose of exchanging Debra M.'s OxyContin for Teresa B.'s
Methadone.
14. Debra M. traded her OxyContin that she received, based upon
(the Respondent's) prescriptions, with Teresa B. as well as other drug
abusers. Debra M. would exchange one (1) OxyContin 80 mg tablets for
two (2) Methadone 40 mg tablets and had, over a period of time,
exchanged hundreds of OxyContin tablets with Teresa B. Debra M. also
engaged in sales of large quantities of OxyContin tablets.
15. On March 17, 2001, Kimberly (P.), age 24, died. She and her
husband were (Respondent's) patients and both were drug abusers. A
prescription profile from Fallston Pharmacy, Fallston, NC, indicated
that Kimberly (P.) received prescriptions from the Respondent for the
following:
Date and Medication
11/28/00
124 Alprazolam 2 mg
50 OxycodoneAPAP 5-325
12/27/00
124 Alprazolam 2 mg
1/19/01
3 Stadol 10 mg/ml
1/25/01
124 Alprazolam 2 mg
2/26/01
124 Alprazolam 2 mg
16. During the months of February and March 2001, Kimberly (P.'s)
husband, Timothy (P.) received prescriptions from (the Respondent) that
were filled at Fallston Pharmacy for the following medications:
Date and Medication
2/14/01
75 Alprazolam 2 mg
93 Hydrocodone 10-600
3/14/01
120 Hydrocone 10-600
140 Methadone 10 mg
31 Clonazepam 2 mg
17. A prescription profile for Kimberly (P.) for the same time
period from Medi Fare Drug Center, Grove, NC, indicated that she
received prescriptions from (the Respondent) for the following:
Date and Medication
2/26/01
120 Roxicet TA, 5-325
20 Dilaudid 3 mg
30 Prozac 20 mg
3/14/01
14 Prozac 20 mg
30 Prozac 20 mg
18. During the months of February and March 2001, Kimberly (P.'s)
husband, Timothy (P.), received prescriptions from (the Respondent)
that were filled at Medi Fare Drug Center, Grover, NC, for the
following:
Date and Medication
1/12/01
90 Hydrocodone 10-650
75 Alprazolam 2 mg
124 Oramorph 15 mg
2/9/01
9 Hydrocodone 10-650
4 Clonazepam 1 mg
3/14/01
78 Alprazolam 2 mg
19. On or about April 12, 2001, Roger H., 50 years old, died at his
home. Numerous pills were found on and around his body. The decedent
was (the Respondent's) former patient and had completed rehabilitation
for opiate abuse during December 2000. (The Respondent's) office was
advised in January 2001 that Roger H. had recently undergone drug
rehabilitation treatment. The cause of death was overdose of Oxycodone.
The blood level of Oxycodone was .55 mg/L, which was well above the
therapeutic level of .05 mg/L, and even above the potentially lethal
level of .4 mg/L. The Respondent prescribed to the decendent
120 OxyContin, 63 Percocet and an unknown quantity of
Roxicodone per month.
20. On March 26, 2001, DEA became aware of five (5) recent deaths
of individuals residing in Union County, SC. Each of these individuals
were former patients of (the Respondent). These individuals included:
Terry J., Marshall S., George N., Debra G., and Tracey C. The cause of
death for each of the patients, with the exception of Tracey C., was
drug overdose. Although Tracey C's death was ruled to be due to cardiac
arrhythmia, he had a history of drug abuse and his blood contained
metabolites of controlled substances. Tracey C. and Terry J. were known
to have obtained OxyContin from Debra M., and Debra M. was one of (the
Respondent's) patients.
a. Terry J. died of respiratory insufficiency secondary to
synergistic drug overdose.
b. Marshall S. died of respiratory arrest secondary to drug
overdose.
c. George N died of respiratory insufficiency secondary to
synergistic drug overdose.
d. Debra G. died of respiratory arrest from cardiomyopathy, but
multiple drug ingestion was a contributing factor.
21. On December 4, 2001, DEA received from the North Carolina
Office of the Chief Medical Examiner, among other things, copies of six
(6) autopsy reports of former patients of (the
[[Page 71201]]
Respondent) who died of causes related to Oxycodone ingestion. The
decedents lived in Gaston, Cleveland and Rutherford Counties in North
Carolina and included the above mentioned Roger H., as well as the
following individuals (approximate date of death listed after the
name):
a. David M., 3/27/01.
b. Pamela Jean B., 1/5/00.
c. Clifford Ray G., 4.13/00.
d. David B., 8/16/00.
e. Adenna S., 12/3/00.
22. On October 10, 2001, the North Carolina Medical Board (Medical
Board) issued a Notice of Charges and Allegations against (the
Respondent). The complaint alleged that (the Respondent) self-
prescribed, diverted and stockpiled the weight-loss drug Pondimin
(Fenfluramine) for personal consumption without conferring with or
receiving a prescription from (his) personal physician. In addition,
the Medical Board alleged that (the Respondent) deviated from
acceptable standards of medical care in a manner directly related to
(his) dispensation and prescription of controlled substances.
Specifically, the Medical Board alleged, with regard to (his) treatment
of patients, (the Respondent):
a. Failed to perform adequate physical or objective examinations in
order to properly evaluate or diagnose the etiology of patients'
complaints;
b. Failed to perform follow-up physician examinations of patients
including appropriate laboratory studies to rule out or confirm the
causes of pain prior to instituting opioid therapy;
c. Failed to inquire during each patient visit as to whether
patients received medications from other physicians or sources even
though (the Respondent) knew or had reason to believe that many
patients had a history of inappropriately obtaining drugs or engaging
in substance abuse;
d. Failed to monitor patient compliance with (the Respondent's)
prescribed therapeutic regime through appropriate laboratory studies
and fluid screens even though (he) knew or had reason to believe that
many patients had a history of inappropriately obtaining drugs or
engaging in substance abuse.
e. Failed to insist that all prescriptions for each patient be
filled at a single pharmacy in order to adequately monitor patient care
even though (the Respondent) knew or had reason to know that many
patients had a history of inappropriately obtaining drugs or engaging
in substance abuse;
f. Failed to measure the degree and variations of pain symptoms in
order to properly evaluate the effectiveness of therapy; and
g. Failed to vary treatment or attempt non-opioid therapy, even
though (the Respondent) knew or had reason to believe that many
patients had a history of inappropriately obtaining drugs or engaging
in substance abuse.
22. On or about June 11, 2001, (the Respondent was) informed by DEA
investigative personnel that (he was) not permitted to possess
controlled substances that had been dispensed to (his) patients by
virtue of prescriptions written by (the Respondent). (The Respondent)
told DEA investigative personnel that (he) had been collecting and
storing patients' controlled substances. These patients reportedly
could no longer take their medications, sometimes due to allergic
reactions. (The Respondent) said that (he) would write the patient a
new prescription for a different medication and take possession of the
old, discontinued controlled substance. DEA personnel informed (the
Respondent) that the patients' controlled substances belonged to them
and that (the Respondent) could not possess them.
23. On October 3, 2001, DEA and state investigative personnel
conducted an audit of the controlled substances at (the Respondent's)
registered location. In a closet, they located a cabinet full of
controlled substances that (the Respondent) took from (his) patients
when (he) changed their medications. Investigators told (the
Respondent), as they had on June 11, 2001, that once the controlled
substance has been dispensed to the patient, (the Respondent) could not
possess it. DEA completed its audit of (the Respondent's) registered
premises on October 4, 2001, and then destroyed hundreds of dosage
units of controlled substances, including, but not limited to
Methadone, OxyContin, Oramorph, Methylphenidate and Hydromorphone.
24. (The Respondent) circumvented DEA regulations by issuing
multiple prescriptions for a 30-day supply of controlled substances,
including those in Schedule II, to patients including but not limited
to patient Teresa B. The prescriptions included the phrase ``do not
fill until (insert date, either 30 or 60 days from the date on the
prescription).'' The patients would then return to the Medi Fare Drug
Center on a monthly basis, either 30 or 60 days after their visit to
(the Respondent's) office, to fill their prescription(s). This had the
effect of circumventing DEA regulations by, in effect, permitting (the
Respondent's) patients to obtain refills of Schedule II prescriptions.
Under DEA regulations, prescriptions are to be dated as of the date of
issue. See 21 CFR 1306.05(a)(``All prescriptions for controlled
substances shall be dated as of, and signed on, the day when issued * *
*'') Prescriptions for Schedule II controlled substances are not
refillable. See 21 CFR 1306.12 (``The refilling of a prescription for a
Schedule II controlled substances listed in Schedule II is
prohibited'').
By letter dated February 26, 2002, the Respondent requested a
hearing in this matter. After the parties filed respective prehearing
submissions, on June 26, 2002, the Government filed a Request for Stay
of Proceedings and Motion for Summary Disposition. In support of its
motion, the Government asserted that on June 20, 2002, the Medical
Board issued Findings of Fact, Conclusions of Law and Order of
Discipline in a disciplinary proceeding against the Respondent. The
Medical Board's action resulted in the indefinite suspension of the
Respondent's medical license, effective April 18, 2002.
On March 28, 2002, Administrative Law Judge Gail A. Randall (Judge
Randall) issued her opinion, Order, and Recommended Ruling of the
Administrative Law Judge (Opinion and Recommended Ruling). In her
Opinion and Recommended Ruling, Judge Randall granted the Government's
motion for summary disposition, and found that the Respondent lacks
authorization to handle controlled substances in the State of North
Carolina, and that the Respondent's medical license is unlikely to be
reinstated in the near future.
In granting the Government's motion, Judge Randall also recommended
that the Respondent's DEA registration be revoked and any pending
applications for modification or renewal be denied. Neither party filed
exceptions to her Opinion and Recommended Ruling, and on August 21,
2002, Judge Randall transmitted the record of these proceedings to the
Office of the Deputy Administrator.
The Deputy Administrator has considered the record in its entirety,
and pursuant to 21 CFR 1316.67, hereby issues his final order based
upon findings of fact and conclusions of law as hereinafter set forth.
The Deputy Administrator adopts, in full, the Opinion and Recommended
Ruling of the Administrative Law Judge.
The Deputy Administrator finds that in its June 20, 2002 Order, the
Medical Board reached findings that were alleged in its October 10,
2001 Notice of Charges. Those findings included inter alia, that the
Respondent routinely failed to inquire as to whether a patient received
medications from other physicians or sources when he knew or had reason
to believe the patient was
[[Page 71202]]
abusing drugs. The Medical Board also found that the Respondent
diverted and stockpiled the weight-loss drug Pondimin (Fenfluramine) (a
Schedule IV controlled substance) for his personal use by asking the
patients to return their supplies of the drug to him. Consistent with
its findings and conclusions, the Medical Board ordered the indefinite
suspension of the Respondent's North Carolina medical license. In
addition, the Medical Board ordered that the Respondent may petition
for reinstatement of his medical license ``no sooner than April 18,
2003.''
There is no evidence before the Deputy Administrator to rebut
findings that effective April 18, 2002, the Respondent's license to
practice medicine in the State of North Carolina was indefinitely
suspended and that he is not eligible to petition for reinstatement of
that license until April 18, 2003. Therefore, the Deputy Administrator
finds that since the Respondent is not currently authorized to practice
medicine in North Carolina, it is reasonable to infer that he is not
authorized to handle controlled substances in that state.
DEA does not have statutory authority under the Controlled
Substances Act to issue or maintain a registration if the applicant or
registrant is without state authority to handled controlled substances
in the state in which he conducts business. See 21 U.S.C. 802(21),
823(f) and 824(a)(3). This prerequisite has been consistently upheld.
See Joseph Thomas Allevi, M.D., 67 FR 35581 (2002); Dominick A. Ricci,
M.D., 58 FR 51104 (1993); Bobby Watts, M.D., 53 FR 11919 (1988).
The parties do not dispute the fact that Respondent is currently
without authorization to handle controlled substances in North
Carolina. Therefore, it is well settled that when no question of
material fact is involved, a plenary, adversary administrative
proceeding involving evidence and cross-examination of witnesses is not
obligatory. See Gilbert Ross, M.D., FR 8664 (1996); Philip E. Kirk,
M.D., 48 FR 32,887 (1983), aff'd sub nom Kirk v. Mullen, 749 F.2d 297
(6th Cir. 1984); NLRB v. International Association of Bridge,
Structural and Ornamental Ironworkers, AFL-CIO, 549 F.2d 634 (9th Cir.
1977). This standard also applies in matters involving the immediate
suspension of a DEA Certificate of Registration under 21 U.S.C. 824(d).
Chemical Dependence Associates of Houston, 58 FR 3705 (July 12, 1993).
Here, it is clear that the Respondent is not licensed to handle
controlled substances in North Carolina. Since Respondent lacks such
authority, he is not entitled to a DEA registration in that state. In
light of the above, Judge Randall properly granted the Government's
Motion for Summary Disposition.
Because the Respondent is not entitled to a DEA registration in
North Carolina Due to his lack of state authorization to handle
controlled substances, the Deputy Administrator concludes that it is
unnecessary to address whether the Respondent's registration should be
revoked based upon the other grounds asserted in the Order to Show
Cause and Notice of Immediate Suspension of Registration. See
Nathaniel-Aikens-Afful, M.D., 62 FR 16871 (1997).
Accordingly, the Deputy Administrator of the Drug Enforcement
Administration, pursuant to the authority vested in him by 21 U.S.C.
823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that DEA
Certificate of Registration, AT2853706, issued to Joseph H. Talley,
M.D., be, and it hereby is, revoked. The Deputy Administrator further
orders that any pending applications for renewal of such registration
be, and they hereby are, denied. This order is effective December 20,
2002.
Dated: November 20, 2002.
John B. Brown, III,
Deputy Administrator.
[FR Doc. 02-30256 Filed 11-27-02; 8:45 am]
BILLING CODE 4410-09-M