[Federal Register Volume 67, Number 230 (Friday, November 29, 2002)]
[Notices]
[Pages 71198-71202]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-30256]


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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