[Federal Register Volume 63, Number 223 (Thursday, November 19, 1998)]
[Notices]
[Pages 64280-64284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30884]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration
[Docket No. 96-4]


Cuong Trong Tran, M.D.; Denial of Application

    On October 13, 1995, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration (DEA), issued an 
Order to Show Cause to Cuong Trong Tran, M.D. (Respondent), of 
Alexandria, Virginia, notifying him of an opportunity to show cause as 
to why DEA should not deny his application for registration as a 
practitioner under 21 U.S.C. 823(f), for reason that such registration 
would be inconsistent with the public interest.
    By letter dated November 13, 1995, Respondent filed a request for a 
hearing, and following prehearing procedures, a hearing was held in 
Arlington, Virginia on June 3, 4 and 17, 1996, before Administrative 
Law Judge Mary Ellen Bittner. At the hearing both parties called 
witnesses to testify and introduced documentary evidence. After the 
hearing, the Government submitted proposed findings of fact, 
conclusions of law and argument, and Respondent filed a letter in reply 
to the Government's submission. On January 13, 1998, Judge Bittner 
issued her Opinion and Recommended Ruling, Findings of Fact, 
Conclusions of Law and Decision, recommending that Respondent's 
application for a DEA Certificate of Registration should be denied. On 
April 24, 1998, Respondent filed exceptions to Judge Bittner's Opinion 
and Recommended Ruling, and subsequently, Government counsel filed a 
response to Respondent's exceptions. Thereafter, on May 14 and 21, 
1998, Judge Bittner transmitted the record of these proceedings to the 
Acting Deputy Administrator.
    The Acting 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 Acting Deputy Administrator adopts, in full, the Opinion and 
Recommended Ruling of the Administrative Law Judge. His adoption is in 
no manner diminished by any recitation of facts, issues and conclusions 
herein, or of any failure to mention a matter of fact or law.
    The Acting Deputy Administrator finds that Respondent graduated 
from medical school in 1965. He has been practicing as a general 
practitioner in Alexandria, Virginia since 1974. In 1979, a state 
inspector advised Respondent that a number of his patients were known 
drug abusers; that it appeared that the patients were seeing Respondent 
only to obtain drugs; and that Respondent should be more careful in 
prescribing to his patients. According to the inspector, Respondent 
indicated that he would be more careful.
    Sometime prior to December 1990, DEA and a local police department 
received reports from local pharmacies and from the Virginia Board of 
Medicine that Respondent was excessively prescribing controlled 
substances over extended periods of time. As a result of

[[Page 64281]]

this information, investigators conducted a survey of 35 area 
pharmacies and determined that approximately 30 individuals were 
receiving a large number of controlled substance prescriptions from 
Respondent.
    Between December 19, 1990 and February 21, 1991, two undercover 
officers and a cooperating individual went to Respondent's office in an 
attempt to obtain controlled substance prescriptions for no legitimate 
medical purpose. The cooperating individual went to Respondent's office 
on December 19, 1990 and January 10 and 16, 1991, wearing a concealed 
body wire which was monitored. During these visits, the cooperating 
individual had visible needle marks on his hands and arms from 
intravenous heroin use. At the first visit, the cooperating individual 
told Respondent that he had knee surgery in the past and that he had 
been taking pain killers for a long time. He indicated to Respondent 
that he needed to see him once a month, and asked for a specific 
controlled substance. After further conversation, Respondent asked 
``Where is the pain now?'' and the cooperating individual reminded 
Respondent that it was an old knee injury and it was better. However, 
Respondent later asked whether the cooperating individual had knee pain 
and the individual answered, ``Yes.'' Respondent issued the cooperating 
individual a prescription for Vicodin following a very cursory 
examination.
    During the second visit, the individual indicated that he had run 
out of his medicine and referred to ``that old knee injury from '85.'' 
Respondent told the cooperating individual that Vicodin ``is 
addicting,'' to which the individual responded, ``I know it's 
addicting, I've been taking it for five years and it's hard to get 
through without it, you know.'' Respondent nonetheless issued the 
individual a prescription for Vicodin. During the final visit, 
Respondent warned the individual of the addictive properties of Vicodin 
and advised him to take as little of the drug as possible and only when 
needed. Respondent did not examine the individual's knee.
    An undercover police officer went to Respondent's office on eight 
occasions between December 19, 1990 and February 21, 1991. At first, 
the undercover officer indicated that he liked to feel a ``little 
mellowed out.'' Respondent asked if the officer was nervous, to which 
he replied, ``okay.'' The officer received a prescription for Valium. 
While Respondent's patient chart for the officer indicates that a 
physical examination was performed, the officer testified that there 
was no examination. During the second visit on December 27, 1990, 
Respondent asked if the undercover officer was nervous. The officer 
said, ``Yeah * * * that Valium just didn't make me feel any better. * * 
*'' Respondent refused the undercover officer's request for Percodan, 
but gave him a prescription for Xanax instead. According to the 
officer, Respondent listened to his breathing, but did not perform any 
other physical examination. At the next visit, the undercover officer 
indicated that he was not nervous, but that he wanted something 
stronger than Xanax. Respondent issued him a prescription for Ativan. 
For the next two visits, the undercover officer did not discuss any 
health problems whatsoever with Respondent and just asked for a 
prescription. Respondent warned the officer of the addictive nature of 
the prescribed drugs, but nonetheless issued prescriptions for Ativan. 
On the sixth visit, Respondent asked the officer if he felt ``like 
[you're] a little nervous and everything,'' to which the officer 
responded, ``yeah.'' Respondent gave the officer a prescription for 
Ativan. Finally, on the last two visits, the undercover officer 
indicated that he was feeling good. On one occasion, Respondent stated 
that the officer had come back too soon for another prescription. 
Respondent issued the officer Ativan prescriptions on both occasions.
    A second undercover officer went to Respondent's office on four 
occasions between January 23 and February 21, 1991. During the first 
visit, the officer repeatedly asked for a prescription for Percodan. He 
offered to pay Respondent $100.00 instead of the $35.00 office visit 
charge. The officer told Respondent that he had obtained Percodan from 
another physician who told him that he had to have severe pain, but 
``between you and me I really don't have severe pain. * * *'' He also 
told Respondent that he had sold Percodan in the past. Respondent asked 
the undercover officer if he had back pain, and the officer replied, 
``I guess if I have to, I'll have back pain.'' After further 
conversation, Respondent said ``if you have pain come in here. I don't 
want to see you if you don't have pain.'' Respondent gave the officer a 
prescription for 30 Vicodin, telling him to take it only for pain. At 
the second visit, the undercover officer asked for Percocet and 
repeatedly said that he was not in any pain. Respondent issued the 
officer a prescription for 30 Vicodin, but told him not to take it if 
he was not in pain. During the next visit, the undercover officer 
indicated that he had run out of medicine. Respondent stated that the 
officer was back too soon for another prescription and should only take 
the drugs if he was in pain. The officer than stated, ``So, if I don't 
have any pain, I don't get any, right?'' The officer then stated that 
he had pain and asked Respondent to check his back. Respondent gave the 
officer a prescription for 20 Vicodin. On Respondent's final visit, 
Respondent again stated that the officer had returned too soon and 
repeatedly told the officer that he should only take the pills when he 
had pain and that they were addictive. The undercover officer said 
that, ``if I have to come back, I'll make sure I have pain.'' 
Respondent issued the officer a prescription for 20 Vicodin.
    After the pharmacy surveys and the undercover visits, search 
warrants were executed at Respondent's office in October 1991 and April 
1992, during which various patient records were seized. Subsequently, a 
number of Respondent's patients were interviewed.
    In her Opinion and Recommendation Ruling, Findings of Fact, 
Conclusions of Law and Decision, Judge Bittner went into great detail 
regarding the prescriptions discovered during the pharmacy surveys, the 
information contained in the patient charts, what was learned during 
the patient interviews and the testimony of some of these individuals 
in subsequent criminal trials. Since the Acting Deputy Administrator is 
adopting Judge Bittner's findings of fact in their entirety, there is 
no need for him to reiterate them. However, the Acting Deputy 
Administrator makes the following general findings regarding 
Respondent's prescribing to the individuals at issue.
    In general, the individuals complained of headaches, backaches, 
pain in various other parts of the body, nervousness and anxiety. They 
usually saw Respondent two to five times a month for several years. At 
virtually every visit, they were prescribed controlled substances with 
little or no other treatment. Respondent performed little or no 
physical examinations and there were very few, if any, referrals to 
specialists. There was no apparent attempt by Respondent to determine 
the cause of the alleged problems. A number of the individuals were 
admitted drug abusers and exhibited some of the classic signs of drug 
abuse. Most of the individuals were required by Respondent to sign 
documents which essentially stated that they had been advised of the 
habit forming nature of the prescribed controlled substances; that they 
have tried other medications in the past, but the prescribed

[[Page 64282]]

controlled substances are the only medications that help; and that they 
assume all responsibility for the misuse of the medication prescribed 
by Respondent. Respondent told some of the individuals to avoid taking 
the prescriptions to certain pharmacies, particularly ones with 
computers; to take the prescriptions to various pharmacies; or to take 
the prescriptions to Maryland or Washington, D.C. to be filled.
    One patient indicated that Respondent had a reputation in the 
community as a physician from whom it was easy to obtain drugs. A 
pharmacist called Respondent and told him that Respondent was issuing 
controlled substance prescriptions to an individual who was also 
getting such prescriptions from other physicians. Respondent told the 
pharmacist to go ahead and fill the presented prescription. Respondent 
refused to issue an individual another controlled substance 
prescription, indicating that some of his other patients had gotten him 
in trouble with DEA, and he stopped prescribing to another individual, 
telling her that he was having some troubles.
    A pharmacist sent letters to Respondent regarding two patients 
asking Respondent for a diagnosis for the prescriptions issued since 
they were receiving a large number of prescriptions from Respondent. An 
insurance company wrote to Respondent regarding one of his patients 
seeking a diagnosis in light of an overabundance of prescriptions. 
There is no indication that Respondent replied to any of these letters.
    One patient told Respondent that he had abused drugs in the past. 
Respondent routinely issued him controlled substance prescriptions for 
an alleged back problem. At some point, Respondent indicated that he 
could no longer issue the individual prescriptions for his back problem 
and the individual would have to have some other problem. The 
individual said that a tooth was bothering him when in fact he did not 
have a toothache. Respondent issued the individual controlled substance 
prescriptions regularly for five months for his alleged toothache. 
Thereafter, the patient chart indicates that Respondent prescribed the 
individual controlled substances supposedly for knee pain following 
surgery even though the individual was being treated by an orthopedist 
and he did not have any pain after the first week following surgery.
    Experts for both the Government and Respondent reviewed 
Respondent's controlled substance prescribing. The Government experts 
essentially concluded that there was no legitimate medical purpose for 
Respondent's continued prescribing of controlled substances to the 
individuals at issue, or at the very least it was not good medicine. 
One expert found Respondent's prescribing to be clear abuse, gross 
misuse of addicting substances, inappropriate and indiscriminate. The 
other expert stated that with no tests to determine the cause, ``the 
continued use of narcotics for headaches is reprehensible.'' He further 
testified that,

    I am not saying he is a bad doctor. I'm simply saying that he 
was duped many times over, and I think that's the reprehensible 
problem. He needed to think more clearly about why he was giving 
narcotics. There was one person here who had 500 prescriptions for a 
narcotic. I mean, * * * that's just never going to happen in real 
life with primary care physicians. It's just not going to happen. 
And yet it happened in his case, and it happened many times over * * 
*.

This expert also testified that when treating individuals with severe 
prolonged pain, he generally maintains them on narcotics for no more 
than one to two weeks and invariably refers them to a specialist if the 
narcotics are not successful. This expert further testified that while 
it is appropriate to warn patients of the addictive potential of 
controlled substances, he had never seen in his 35 years of practice a 
consent for, or a waiver for narcotics like the one that was used by 
Respondent.
    Respondent's experts essentially felt that Respondent's prescribing 
was appropriate. However, neither of Respondent's experts were family 
practitioners. One of the experts felt that Respondent's patients 
described the normal signs of people suffering from migraine headaches 
and that prescribing of controlled substances is common for an acute 
migraine. But according to the expert, long-term use of controlled 
substances causes addiction which results in a vicious cycle because 
abrupt cessation of the medication will cause the patient to develop a 
headache. The expert testified that in such a situation, the patient 
needs to be hospitalized to manage the withdrawal from the controlled 
substances. Respondent's other expert indicated that if a patient with 
chronic pain made four or five visits to him and the pain was only 
alleviated by a narcotic, he would refer the patient to a specialist.
    In 1992, Respondent was indicted in the United States District 
Court for the Eastern District of Virginia on 136 counts of prescribing 
controlled substances outside the usual curse of medical practice and 
for other than legitimate medical purposes in violation of 21 U.S.C. 
841(a)(1). Following a jury trial, Respondent was found guilty of 127 
counts of unlawful distribution of controlled substances.
    As a result of his conviction, on April 26, 1993, the Virginia 
Board of Medicine (Medical Board) revoked Respondent's license to 
practice medicine in Virginia. Thereafter, DEA revoked Respondent's 
previous DEA Certificate of Registration by order published on July 12, 
1993. See 58 Fed Reg. 37,506 (1993).
    On February 28, 1994, the United States Court of Appeals for the 
Fourth Circuit reversed Respondent's conviction on 80 counts based upon 
insufficient evidence to convict, and reversed and remanded for a new 
trial the convictions on 47 counts because reputation evidence and a 
medical expert's hearsay opinion were improperly admitted into 
evidence. Subsequently Respondent was charged in a superseding 
indictment with 45 counts of unlawful distribution of controlled 
substances in violation of 21 U.S.C. 841(a)(1). Respondent was tried on 
these counts in July 1994 and was acquitted on all charges. Following 
his acquittal, the Medical Board issued an order on August 15, 1994, 
vacating its earlier revocation of Respondent's medical license.
    At the hearing in this matter, Respondent testified that he is ``a 
changed man,'' and that he is now aware and more careful about giving 
narcotics to patients. However, he did not acknowledge that he had in 
any way improperly prescribed controlled substances. Respondent 
admitted that he told patients to go to different pharmacies, but said 
that he did so to encourage his patients to find the best price for 
their prescriptions. He denied that he ever told his patients to avoid 
having their prescriptions filled at pharmacies with computers or to 
spread their prescriptions among various pharmacies. Respondent further 
testified that pain is subjective, that he gives the patient the 
benefit of the doubt, and that ``[m]y conscience say I have to trust 
people and now, after I go through that, I know you have to be careful 
not to trust people so much. * * *''
    Respondent also testified that if he is issued a DEA registration, 
``I swear that I will not give controlled substances anymore, because 
this does not do any good to me.'' He stated that he needs a DEA 
registration in order to obtain hospital privileges, to be accepted by 
insurance companies as a provider, and to have his prescriptions for 
non-

[[Page 64283]]

controlled substances filled at pharmacies.
    Pursuant to 21 U.S.C. 823(f), the Deputy Administrator may revoke a 
DEA Certificate of Registration and deny any application for such 
registration, if he determines that the continued registration would be 
inconsistent with the public interest. Section 823(f) requires that the 
following factors be considered:
    (1) The recommendation of the appropriate state licensing board or 
professional disciplinary authority.
    (2) The applicant's experience in dispensing, or conducting 
research with respect to 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 pubic heath or 
safety. These factors are to be considered in the disjunctive; the 
Deputy Administrator may rely on any one or a combination of factors 
and may give each factor the weight he deems appropriate in determining 
whether a registration should be revoked or an application for 
registration denied. See Henry J. Schwarz, Jr., M.D., 54 Fed. Reg. 
16,422 (1989).
    Regarding factor one, it is undisputed that the Medical Board 
revoked Respondent's medical license following his conviction, but then 
reinstated it after his acquittal on all charges. Therefore, Respondent 
currently possesses an unrestricted state license to practice medicine 
and handle controlled substances. But, the Acting Deputy Administrator 
agrees with Judge Bittner that ``inasmuch as state licensure is a 
necessary but not sufficient condition for DEA registration, * * * this 
factor is not dispositive.''
    As to factors two and four, Respondent's experience in dispensing 
controlled substances and his compliance with applicable laws relating 
to controlled substances, the Acting Deputy Administrator agrees with 
Judge Bittner that ``[t]he record is replete with examples of 
Respondent's prescribing of controlled substances in a manner which is 
most charitably described as totally irresponsible.'' Pursuant to 21 
CFR 1306.04, controlled substances may only be prescribed for 
legitimate medical purpose. There are many instances that suggest that 
Respondent was indiscriminately prescribing controlled substances. 
Respondent prescribed controlled substances to individuals on a regular 
basis over an extended period of time based solely on the subjective 
complaints of the individuals with little or no effort to determine the 
cause of the individual's problems or to refer them to specialists. 
Judge Bittner found the Government's expert who testified at the 
hearing to be ``a knowledgeable, credible expert who thoroughly 
considered the information available to him.'' The expert found that 
there was no legitimate medical reason for Respondent's continued 
prescribing of controlled substances to almost all of the individuals.
    The undercover visits raise serious concerns regarding Respondent's 
dispensing of controlled substances. One undercover officer repeatedly 
requested Percodan by name, told Respondent that he sold Percodan, and 
offered to pay Respondent $100.00 rather than the standard $35.00 
office visit charge. In response to Respondent's question about whether 
he had any pain, the undercover officer stated that, ``I guess if I 
have to, I'll have back pain.'' While Respondent refused to prescribe 
the undercover officer Percodan he did issue him prescriptions for 
Vicodin. The other undercover officer's patient chart indicates that 
Respondent performed a physical examination on the initial visit before 
issuing the officer a controlled substance prescription. However, the 
officer testified that Respondent did not perform any sort of an 
examination. As to the cooperating individual, Respondent issued him 
prescriptions for a narcotic even though the individual had visible 
needle marks on his hands and arms.
    There are other indications in the record that Respondent himself 
was not completely comfortable with his prescribing of controlled 
substances to the individuals at issue. First, Respondent had his 
patients sign documents wherein the patients indicated that they would 
``take all the responsibility of the misuse of the medicine prescribed 
for my health by Tran-Cuong MD.'' As a DEA registrant, a physician must 
ensure that the controlled substances that he/she prescribes are only 
used for a legitimate medical purpose. These waivers are an attempt by 
Respondent to abrogate this responsibility. Second, according to a 
number of the individuals, Respondent told them to take their 
prescriptions to various pharmacies, to avoid pharmacies with computers 
and to take them to be filled at pharmacies in Maryland and Washington, 
D.C. Respondent contends that he never told the individuals to take 
their prescriptions to different pharmacies or to avoid pharmacies with 
computers, but that he only encouraged the individuals to find the best 
price for their medication. Since a number of the individuals related 
the same information, the Acting Deputy Administrator does not find 
Respondent's explanation credible. Finally, Respondent stopped 
prescribing controlled substances to at least two of the individuals 
stating that he was having trouble with DEA. This seems to suggest that 
Respondent himself doubted the legitimacy of the prescriptions that he 
had been issuing to these individuals.
    The Acting Deputy Administrator concurs with Judge Bittner's 
finding ``that Respondent prescribed controlled substances to numerous 
patients, over long periods of time, in contravention of his 
responsibility to establish that there was a medical need for these 
prescriptions.''
    Regarding factor three, while Respondent was initially convicted of 
127 counts of unlawful distribution, these charges were ultimately 
disposed of by reversal, dismissal or acquittal. Therefore, there is no 
evidence that Respondent has been convicted of any charges relating to 
controlled substances.
    As to factor five, Judge Bittner stated that ``Respondent's 
continuing attempts to justify his prescribing practices warrant the 
inferences * * * that although Respondent clearly regrets the legal 
financial and personal difficulties that arose from his prescribing 
practices, he still does not fully acknowledge his wrongdoing.* * *''
    Judge Bittner concluded that ``Respondent is unwilling and/or 
unable to accept the responsibilities inherent in holding a DEA 
registration.'' Therefore, Judge Bittner found that Respondent's 
registration would be inconsistent with the public interest and 
recommended that his application be denied.
    Respondent filed exceptions to Judge Bittner's recommendation 
stating that denial is too harsh a penalty since this is his first 
offense and he ``was acquitted of criminal charges which were based on 
the same factual situation presented here.'' The Acting Deputy 
Administrator notes that these proceedings are not punitive in nature, 
but instead look to protect the public health and safety. See Richard 
J. Lanham, M.D., 57 Fed. Reg. 40,475 (1992); Richard A. Cole, M.D., 57 
Fed. Reg. 8677 (1992). In evaluating this case, the Acting Deputy 
Administrator finds it noteworthy that Respondent was warned in 1979 
that he was being conned by known drug abusers to issue them controlled 
substance prescriptions. Respondent

[[Page 64284]]

acknowledged this information, yet failed to exercise proper care in 
his future prescribing. In addition, while it is true that Respondent 
was acquitted of all criminal charges, a conviction is not a necessary 
prerequisite for denial. Careless or negligent handling of controlled 
substances creates the opportunity for diversion and could justify 
revocation or denial. As Respondent's counsel noted in his closing 
argument at Respondent's second criminal trial:

    * * * because if Dr. Tran didn't notice what he should have 
noticed, that is not a crime. That may be bad doctoring. That may be 
carelessness. That may be a reason perhaps why someone shouldn't be 
a doctor * * *.''

The Acting Deputy Administrator concludes that Respondent's careless 
and indiscriminate prescribing of controlled substances warrant the 
denial of his application for registration.
    Also in his exceptions, Respondent contends that ``this procedure 
has been a learning experience. I now realize the importance of 
maintaining detailed medical records on each patient * * * [and] I am a 
more enlightened man when it comes to prescribing controlled substances 
for a legitimate medical purpose only.'' Respondent says that he will 
only prescribe for a legitimate medical purpose and that he is a 
``changed man,'' but he does not acknowledge that he prescribed 
improperly. Therefore, the Acting Deputy Administrator is not confident 
that Respondent recognizes what needs changing in his handling of 
controlled substances. There is no evidence in the record how 
Respondent has changed or that he has attempted to better educate 
himself in the proper handling of controlled substances. As a result, 
the Acting Deputy Administrator does not believe that it is in the 
public interest for Respondent to be issued a registration at this 
time.
    Finally, in his exceptions and during the hearing in this matter, 
Respondent indicated that if he is issued a DEA registration, he will 
refrain from dispensing controlled substances ``because it not only get 
me in trouble, it doesn't do anything to me.'' According to Respondent 
without a DEA registration he cannot get hospital privileges, he is not 
accepted as a provider by insurance companies, pharmacies will not fill 
his non-controlled prescriptions, and pharmaceutical representatives 
refuse to give him samples of non-controlled substances. While 
Respondent's predicament is unfortunate, it does not justify granting 
him a DEA registration. Practitioners are issued DEA registrations so 
that they can responsibly handle controlled substances, not so that 
they can obtain hospital privileges. In light of Respondent's failure 
to acknowledge any wrongdoing, the lack of any details as to how he has 
changed, and the absence of any recent training in the proper handling 
of controlled substances, the Acting Deputy Administrator concludes 
that it would be inconsistent with the public interest to grant 
Respondent's application for a DEA Certificate of Registration at this 
time.
    Accordingly, the Acting Deputy Administrator of the Drug 
Enforcement Administration, pursuant to the authority vested in him by 
21 U.S.C. 823 and 28 CFR 0.100(b) and 0.104, hereby orders that the 
application for registration, executed by Cuong Trong Tran, M.D., be, 
and it hereby is, denied. This order is effective December 21, 1998.

    Dated: November 13, 1998.
Donnie R. Marshall,
Acting Deputy Administrator.
[FR Doc. 98-30884 Filed 11-18-98; 8:45 am]
BILLING CODE 4410-09-M