[Federal Register Volume 63, Number 187 (Monday, September 28, 1998)]
[Notices]
[Pages 51592-51602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25827]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration
[Docket No. 95-54]


Paul J. Caragine, Jr., Grant of Restricted Registration

    On July 10, 1995, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration (DEA), issued an 
Order to Show Cause to Paul Caragine, M.D., (Respondent) of Denville, 
New Jersey, 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), as being inconsistent with the public interest.
    By letter dated September 6, 1995, Respondent, through counsel, 
filed a request for a hearing, and following prehearing procedures, a 
hearing was held in Newark, New Jersey on June 25, 26 and 27 and 
November 19, 20 and 21, 1996, before Administrative Law Judge Mary 
Ellen Bittner. At the hearing, both parties called witnesses to testify 
and introduced documentary evidence. After the hearing, counsel for 
both parties submitted proposed findings of fact, conclusions of law 
and argument. On March 31, 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 be denied. On April 17, 1998, Respondent filed exceptions 
and objections to Judge Bittner's opinion and on May 4, 1998, the 
Government filed its response to Respondent's exceptions. Thereafter, 
May 8, 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 
ordered based upon findings of fact and conclusions of law as 
hereinafter set forth. The Acting Deputy Administrator adopts, the 
findings of fact and conclusions of law set forth in the Opinion and 
Recommended Ruling, Findings of Fact, Conclusions of Law and Decision 
of the Administrative Law Judge, except as specifically noted below, 
but does not adopt the Administrative Law Judge's recommended ruling. 
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 received his 
medical degree in 1971 from what is now the University of Medicine and 
Dentistry of New Jersey, and first become licensed to practice medicine 
in New Jersey in 1973. He has practiced orthopedic medicine in various 
locations throughout the State of New Jersey. According to Respondent 
he has treated approximately 15,000 patients over a 20-year period.
    In 1988, a New Jersey state agency initiated an investigation of 
Respondent based upon information from a pharmacist about prescriptions 
Respondent had issued to two individuals. Thereafter, a state 
investigator collected and reviewed controlled substance prescriptions 
issued by Respondent to 11 patients.
    Based upon the investigator's review, the New Jersey Medical Board 
(Medical Board) held an informal hearing on November 27, 1991, 
regarding Respondent's prescribing practices. Respondent testified at 
that hearing that he believed in using pain killing drugs for patients 
who needed them to function. However, Respondent also stated that, 
``I'm a lot stricter and tougher about this than I was. I mean, as I 
look back I realize that I was really too lenient with all these 
people. * * * I must appear to be a fool and I'm setting myself up here 
by going along with all these people, going along with all these 
stories. * * * No more. In the last three years I've had a really 
exemplary record. I'm very careful. I'm not so easy to get drugs out of 
like I use[d] to be.'' Respondent emphasized that only two of the 
patients at issue were still under his care and that he had told them 
that he would stop prescribing controlled substances to them on April 
1, 1992. Respondent further asserted that ``there are no new people out 
there who represent future problems for this board or for me,'' and 
that ``I want the board to know that I really made an effort to clean 
up my act and not be permissive. My only past sin was being too 
gullible and too charitable.'' When asked what had prompted the change, 
Respondent stated that, ``It just occurred to me after a period of time 
that this couldn't be right.''
    During this same time period, a local police department received 
information in August 1991 that two individuals were suspected of 
distributing narcotics. A subsequent survey of area pharmacies revealed 
that Respondent had issued most of the controlled substance 
prescriptions for these individuals. A review of the prescriptions 
showed, among other things, that one of the individuals obtained 480 
dosage units of Vicodin, a Schedule III controlled substance, between 
August 22 and September 23, 1992, pursuant to prescriptions and refills 
authorized by Respondent. On October 2, 1992, a search warrant was 
executed at the individuals' apartment, during which investigators 
discovered marijuana, marijuana paraphernalia, 88 prescription vials 
(86 of which were empty), a prescription for Percocet written by 
Respondent and postdated October 7, 1992, and notes indicating drug 
distributions. Approximately 85-90% of the prescription vials indicated 
that they were authorized by Respondent.
    The individuals were interviewed following their arrest for among 
other things, possession of marijuana and drug paraphernalia. One of 
the individuals admitted that she had filled

[[Page 51593]]

prescriptions from Respondent at one pharmacy and had then called him, 
said that she had lost a prescription, and had him authorize another 
prescription by telephone at a different pharmacy. The other individual 
admitted that he was addicted to controlled substances and stated that 
he sold controlled substances prescribed to him by Respondent.
    On October 14, 1992, Respondent was interviewed by state and DEA 
investigators. According to the investigators, Respondent told them 
that he knew from the beginning of his treatment of the one individual 
that the patient was addicted to prescription drugs. At the hearing in 
this matter, Respondent disputed that he told this to the 
investigators, however Judge Bittner found the investigators to be more 
credible than Respondent. Respondent also admitted to the investigators 
that he issued the postdated prescription, but that he did so to save 
the individual the expense of another office visit and to better 
control his intake of controlled substances.
    On July 12, 1993, a complaint was filed with the Medical Board 
seeking the temporary suspension and permanent revocation of 
Respondent's medical license on grounds that he had excessively 
prescribed controlled substances, issued prescriptions for controlled 
substances before the supply previously dispensed to the patient should 
have been exhausted, failed to maintain medical records on patients to 
whom he prescribed controlled substances, continued to prescribe 
narcotic analgesics to a patient after she was hospitalized for 
treatment of an overdose of these medications, and issued postdated 
prescriptions. Following a hearing, the Medical Board issued an order 
temporarily suspending Respondent's license to practice medicine 
effective August 25, 1993, and suspending his authority to handle 
controlled substances as of August 11, 1993, on grounds that Respondent 
had inappropriately prescribed controlled substances to 14 patients. As 
a result of the Medical Board's action, Respondent surrendered his 
previous DEA Certificate of Registration on August 16, 1993.
    Subsequently, the Medical Board issued a supplemental complaint 
alleging that Respondent inappropriately prescribed controlled 
substances to two more individuals. Following a hearing, a state 
administrative law judge issued an initial decision dated June 29, 
1994, finding that the patients at issue had serious problems which may 
have resulted in legitimate complaints of pain, but that Respondent 
ignored warning signs which should have alerted him to the dangers of 
dependency, that Respondent did not control the dispensing of 
controlled substances, and that the record supported a conclusion that 
each of the patients was drug dependent. The Judge concluded that 
Respondent's treatment of these patients constituted gross malpractice, 
gross negligence and gross incompetence, professional incompetence, and 
professional misconduct, and that revocation of Respondent's medical 
license was therefore justified.
    On August 11, 1994, the Medical Board issued a Final Order adopting 
the administrative law judge's findings of fact (with minor exceptions) 
and conclusions of law. However, the Medical Board found that there was 
no evidence that Respondent's conduct was ``infected by improper 
motive, such as desire for profit, or complete disregard for patient 
well-being.'' Accordingly, the Medical Board concluded that instead of 
revocation of his medical license, the appropriate sanction was a two 
year suspension, retroactive to August 11, 1993, but with the second 
year stayed and served as a period of probation. The Medical Board also 
prohibited Respondent from prescribing controlled substances until it 
approved a plan for his resumption of such prescribing.
    On August 11, 1994, Respondent executed the application for 
registration with DEA that is the subject of these proceedings. On 
October 28, 1994, the Medical Board modified its order, permitting 
Respondent to handle controlled substances if and when he gets his DEA 
privileges restored provided that for at least one year, he must 
maintain a log of his prescribing and dispensing; he may not prescribe 
or dispense more than a 14-day supply at one time to a patient; and he 
must refer a patient to a pain management specialist for a second 
opinion prior to completion of 90 days of prescribing or dispensing to 
the patient.
    On February 24, 1994, a civil complaint was filed against 
Respondent in the United States District Court for the District of New 
Jersey alleging violations of 21 U.S.C. 842. On March 11, 1996, the 
parties filed a Stipulation for Compromise Settlement, pursuant to 
which Respondent agreed to pay $22,500 plus interest. The stipulation 
provided, among other things, that Respondent did not admit liability 
or fault and that the complaint would be dismissed with prejudice.
    Since Respondent's patients that are at issue in this proceeding 
were supposedly being treated by Respondent for chronic pain, there was 
evidence presented by both the Government and Respondent regarding the 
treatment of chronic pain patients. An expert in pain management 
testified on behalf of the Government and his report regarding 
Respondent's patients was admitted into evidence. Respondent offered 
the report and the testimony before the Medial Board of his expert in 
pain management. The Government's expert testified that chronic pain is 
pain from the same etiology that lasts longer than six months. 
Respondent's expert opined that chronic pain patients are the most 
difficult patient population to treat, that many of these patients are 
angry and depressed, and that psychological complications make managing 
them more difficult.
    Regarding the treatment of pain, the Government's expert testified 
that narcotics do not relive pain, but block the perception of pain in 
the brain, while non-steroidal anti-inflammatory drugs (NSAIDs) may 
operate on the source of the pain. According to the Government's 
expert, narcotic analgesics may be used in conjunction with NSAIDs 
where the pain is severe; preferably starting the patient on the 
narcotic first, then prescribing NSAIDs, and then gradually taking the 
patient off the narcotic and increasing the NSAIDs. Respondent's expert 
testified in the Medical Board proceeding that narcotics may be an 
appropriate permanent solution to a patient's pain problem but that 
``[i]t's certainly not the first one we consider. Usually it's a choice 
of last resort, not first.''
    Respondent also introduced into evidence at the hearing pages of 
the Handbook of Pain Management, G. John DiGregorio, M.D., Ph.D., et 
al. (3rd ed. 1991), which recommends initial treatment of chronic 
benign pain with NSAIDs. The Handbook further advises that ``[t]he 
regular use of opioid analgesics in benign pain syndromes is 
controversial,'' and that

[p]hysicians who choose to use these types of opioids should be 
aware of the potential escalation by the patient to stronger types 
of medication during their treatment program. It is for these 
reasons that all efforts should be made not to utilize opioid 
treatment in these types of syndromes. the administration of strong 
opioids in chronic benign pain syndromes is to be avoided if at all 
possible, since the resulting problems of tolerance, physical 
dependence, and drug-seeking behavior are usually more life-
disrupting than the pain process itself.

    Judge Bittner found that New Jersey law requires that physicians 
prescribe controlled substances only for legitimate medical purposes in 
the course of professional treatment and that physicians must take 
complete histories

[[Page 51594]]

and perform physical examinations of patients. In addition, physicians 
in New Jersey are required to maintain a chart on patients for whom 
they prescribe controlled substances for pain.
    The Government's expert testified that in treating a chronic pain 
patient, the physician should include both positive and negative 
findings in a patient's chart, including information for each visit as 
to whether the pain is better or worse, and whether it is in the same 
place. Respondent's expert asserted that pain is highly subjective and 
the physician must rely on the patient's description of pain, family 
members' reports of it, and how well the patient is able to function.
    Because the Government alleged that a number of Respondent's 
patients were drug dependent, the Government's expert listed some ``red 
flags'' which should alert a physician to possible drug-seeking 
behavior. Specifically, the Government's expert testified that drug-
seeking patients may complain of symptoms that would normally lead a 
doctor to consider prescribing controlled substances, express symptoms 
that are incompatible with the purported injury, try to avoid 
diagnostic procedures which may show that their conditions do not 
warrant treatment with narcotics, ask for a controlled substance by 
name on a first visit, visit physicians some distance from the 
patient's residence, have a history of problems but no medical records, 
often have multiple accidents, multiple fractures, or complain of 
injuring themselves at home or at work, insist on a drug of choice, 
lose prescriptions or medication, take more medication than directed, 
request more medication before the previously dispensed supply should 
have been exhausted, use controlled substances prescribed for others, 
use controlled substances in combination or with alcohol, or obtain 
controlled substance prescriptions from multiple physicians or have 
prescriptions filled at multiple pharmacies. The expert acknowledged 
however, that many doctors ignore these ``red flags.''
    At the hearing in this matter, there was extensive testimony and 
documentary evidence presented regarding Respondent's treatment of 18 
patients, including the prescribing of controlled substances. While the 
patient charts were not offered into evidence, various witnesses, 
including Respondent and the Government's expert, used the charts while 
testifying. In addition, Respondent prepared summaries of his patient 
records which were admitted into evidence. Further, two affidavits by 
Respondent in 1990, Respondent's 1991 testimony in the Medical Board's 
Preliminary Evaluation Committee hearing, the state investigator's 1991 
report, and the state administrative law judge's opinion were admitted 
into evidence without objection. Respondent argues that the Government 
expert's reports should not be relied upon because the underlying 
patient records were missing. Judge Bittner rejected this argument 
noting ``that hearsay is admissible, that [the expert's] reports were 
referenced in a Government prehearing statement filed in January 1996, 
and that Respondent had had a substantial opportunity to raise any 
questions he had about the records on which the report was based.'' The 
Acting Deputy Administrator agrees with Judge Bittner and also notes 
that the reports were properly admitted into evidence at the hearing 
because Respondent's objections to the reports being received into 
evidence were not based upon the lace of underlying patient records.
    In her Opinion and Recommended Ruling, Findings of Fact, 
Conclusions of Law and Decision, Judge Bittner went into great detail 
regarding the medical problems and treatment, including the prescribing 
of controlled substances, of the patients at issue in these 
proceedings. 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 treatment of the 
patients at issue.
    Respondent treat R.C. over a period of approximately eight years. 
Respondent initially saw R.C. for shoulder and elbow pain following a 
motorcycle accident. On a number of occasions, Respondent performed 
surgery on R.C.'s shoulder and ring finger where he removed a benign 
tumor. Throughout the years, R.C. continued to complain of shoulder and 
finger pain. At various times, Respondent prescribed R.C. Percocet, 
Talwin, Darvon and Tylenol with codeine #3. For example, between 
January 2 and January 30, 1985, Respondent prescribed R.C. 335 dosage 
units of Talwin, and during February 1986, he prescribed 290 dosage 
units.
    A note in the patient file dated August 30, 1982, stated, ``give no 
more Darvon.'' Another note in R.C.'s patient file dated May 21, 1985, 
said, ``This is the very last Rx--make it last. Follow exactly as 
written. If he abuses this one--he's finished with us. complaints from 
drug store that entire family does narcotic drug [sic].'' However, 
Respondent continued to prescribe Talwin to R.C., because according to 
Respondent, R.C. re-injured himself. In September 1986, R.C. sought 
another prescription from Respondent claiming that his wife washed his 
pants with the 60 Talwin in them that had been prescribed the day 
before. In a letter to R.C. dated October 9, 1986, Respondent advised 
R.C. that ``I am aware of your desire to have more Talwin tablets. It 
has been brought to my attention by many people, including my 
secretary, pharmacist and the emergency staff at St. Clare's Hospital 
that you have grossly abused this drug.'' Respondent further stated 
that ``to protect my own medical license and to maintain good relations 
with other doctors and nurses, I have to stop giving you this drug and 
any other drugs of comparable strength. You certainly have no reason to 
need this drug anymore anyway. It would be reasonable for you to take 
lesser medications from time to time, such as Darvocet or Tylenol with 
codeine: if you wish, I can give you a prescription for those. You will 
have to obtain Talwin elsewhere.'' Nonetheless, Respondent continued to 
prescribe R.C. Talwin throughout 1987 following continuing complaints 
of shoulder pain. In September 1988, Respondent issued R.C. a duplicate 
prescription after R.C. claimed that he had lost a prescription.
    Before Judge Bittner, Respondent testified that although he did not 
recognize at the time that he was issuing prescriptions that R.C. had a 
drug problem, he would recognize it now. Respondent further testified 
that he believed R.C.'s pain warranted the prescribed medications, but 
that ``I shouldn't have done it. I should have been tougher.''
    Respondent treated M.C. from September 1986 to June 1989. 
Initially, Respondent treated M.C. for back pain and headache resulting 
from a myelogram. Throughout the years, Respondent treated M.C. 
following several falls and car accidents for pain down her leg, 
cervical radiculopathy, and back and shoulder pain. He regularly 
prescribed M.C. Demerol for pain, Halcion for sleep, and Restoril as a 
muscle relaxer and for pain. According to Respondent, only Demerol 
helped M.C.'s pain. Respondent also gave M.C. anti-inflammatories, had 
her undergo physical therapy and traction, and recommended exercise to 
strengthen her muscles. Notes in M.C.'s patient file indicated that 
M.C. sometimes telephoned Respondent requesting prescriptions for pain 
medication and that pharmacies had called Respondent advising that M.C. 
was not following the directions on prescriptions and she was 
attempting to obtain refills of the prescriptions early.

[[Page 51595]]

At the hearing before Judge Bittner, Respondent indicated that his 
prescribing to M.C. helped her, but it also subjected her to possible 
danger.
    Respondent treated patient S.D. from March 28, 1985 through June 
30, 1988. Initially, Respondent treated S.D. for chronic low back pain 
from an old surgery and he and his partner aspirated the site. In 1985, 
S.D. fractured her ankle and she had surgery to remove scar tissue. 
S.D. was hospitalized in 1986 for low back pain and in November 1986, 
she had surgery to remove bone chips. Between July 11, 1985 and June 6, 
1988, Respondent prescribed S.D. 240 Demerol, 430 Percodan, 50 Seconal, 
475 Percocet, 1,387 Tylenol No. 4, 177 Nembutal, and 260 Tylenol No. 3. 
Respondent indicated that S.D. had a threshold for pain and that only 
the drugs prescribed ever helped her. A note in S.D.'s patient file 
dated August 27, 1987, indicated that S.D. was hospitalized for a drug 
overdose and that a pharmacy reported that it would no longer serve 
S.D. since she had seen every doctor in the area in an effort to obtain 
drugs. Four days after this note was written, Respondent issued S.D. a 
prescription for Tylenol No. 4
    The Government's expert testified that he considered Respondent's 
prescribing to S.D. ``egregious'' and that it ``jeopardized certainly 
the welfare and the health and the safety, and even the life of this 
patient.'' The expert further testified that ``this is not gullibility, 
this is total irresponsibility in the prescribing of controlled 
dangerous substances.'' Respondent stated that he ``tried to act in as 
responsible a way as possible,'' that in the last months he saw her, 
S.D. asked for less medication, and that he had given her ``a hard 
time'' with respect to Demerol. Respondent further testified that he 
was concerned about S.D.'s use of controlled substances because the 
first time he met her she told him that she needed more medication than 
most people to achieve the same effect, but that he thought she was 
being honest. Respondent testified that this incident ``goes to show 
how oblivious I was to red flags in front of me.''
    According to T.K., he was Respondent's patient from 1979 until 
January 1993. Respondent diagnosed T.K. in 1981 with a complicated form 
of Osgood-Schlatter's disease which causes inflammation and pain. In 
addition, T.K. had knee operations in 1983 and 1985, and was treated by 
Respondent at various times for tennis elbow, gout and tendonitis in 
the left forearm. Respondent regularly prescribed T.K. both Tylenol 
with codeine and Doriden without always noting it in the patient chart, 
and sometimes without seeing the patient. The Government's expert 
testified that there is no medical justification for prescribing 
Tylenol with codeine and glutethimide (the generic name for Doriden) in 
combination. The combination of these drugs is commonly abused because 
it creates a heroin-like effect. In fact, in 1984, the Medical Board 
sent a newsletter to all physicians which indicated that barring 
unusual circumstances there was no legitimate medical indication for 
prescribing a combination of glutethimide and codeine. Respondent 
testified that he did not recall receiving this newsletter. After the 
1991 hearing before the Preliminary Evaluation Committee of the Medical 
Board, Respondent continued to prescribe both of these drugs to T.K. 
T.K. told the state investigator that ``I never felt that the doctor 
acted in anything but good faith.''
    The Government's expert stated that Respondent issued T.K. new 
prescriptions for Tylenol with codeine before the supply dispensed 
pursuant to previous prescriptions should have been exhausted. The 
expert opined that Respondent's prescribing of controlled substances to 
T.K. was not for a legitimate medical purpose because the prescribed 
medications were not compatible with the diagnosis of what was wrong 
with the patient.
    Respondent testified that he prescribed Doriden to T.K. because he 
had a chronic sleep disorder, and that other physicians had prescribed 
T.K. the drug. He further stated that he never told T.K. to take the 
Tylenol No. 3 and Doriden together.
    G.K. first saw Respondent's partner in January 1990 suffering from 
back spasms and was prescribed Dilaudid. Respondent than began treating 
him approximately one year later for chronic back pain. Respondent 
regularly prescribed G.K. Dilaudid, often issuing a new prescription 
before the previous one should have run out, and often not noting the 
prescription in the patient chart. On one occasion, Respondent issued 
G.K. a new prescription after G.K. represented that he had lost a 
prescription. The pharmacy reviews revealed that Respondent postdated 
Dilaudid prescriptions for G.K. on several occasions. There were notes 
in the file stating that Respondent would not issue any more Dilaudid 
prescriptions to G.K., yet Respondent continued to do so.
    The Government's expert concluded that Respondent prescribed one of 
the most potent narcotics to G.K. notwithstanding G.K.'s obvious drug-
seeking behavior. Respondent testified that G.K. needed Dilaudid for 
pain and especially to sleep, or else he could not go to work. He 
further testified that G.K. would improve for a period of time but then 
would have setbacks. In retrospect, Respondent through that he was 
lenient with G.K. and that G.K. was a drug-seeking patient.
    D.K. initially saw Respondent in August 1982, for injuries that he 
had sustained in a car accident that had occurred several months 
earlier. D.K. was a patient of Respondent's for over ten years. He was 
treated for injuries sustained in five car accidents and other types of 
accidents. During the course of his treatment, D.K. had two low back 
surgeries and ultimately used a cane to walk because his knees 
frequently buckled. According to Respondent, D.K. was the sole support 
for his three children, so he needed pain medication to be able to keep 
working. After anti-inflammatory medications did not work, Respondent 
prescribed D.K. Percodan. Throughout D.K.'s treatment, Respondent 
regularly prescribed, Tylenol No. 3, Vicodin and/or Percodan for pain, 
and sometimes prescribed Restoril for sleep and Valium for muscle 
spasms.
    On several occasions, Respondent's records indicated that he 
intended to either diminish or cease prescribing Vicodin and Percodan 
to D.K. In a November 1990 affidavit, Respondent stated that ``each 
time [D.K.] was just about ready to get off habit-forming medicine, 
that another accident would occur.'' Respondent further stated that he 
wanted D.K. to go to another physician who might be better at getting 
him off of all medicine, but that ``I have no evidence of [D.K.] ever 
abusing medications that I gave him; it was my belief they were so that 
he could go to work.'' However, Respondent nonetheless continued to 
prescribe controlled substances after this affidavit.
    The Government's expert testified that prescribing two narcotics 
simultaneously should be intermittent, and not done on a regular basis 
like Respondent did. The expert further testified that it was his 
opinion that there was no valid medical purpose for Respondent's 
prescribing to D.K. in the types and quantities of controlled 
substances that he did. He emphasized that a physician loses control 
when he prescribes a large quantity of controlled substances with 
refills.
    Respondent testified that it never occurred to him that D.K.'s 
accidents may have been related to his use of controlled substances. 
Respondent further testified that D.K. was one of the

[[Page 51596]]

patients he felt he had not handled properly and that he should have 
been more reluctant to prescribe controlled substances to him.
    Respondent began treating D.K.M. following a car accident in 1982. 
He diagnosed her as having a cervical sprain with radiculopathy and 
prescribed Talwin and exercises. When the Talwin did not appear to be 
working, Respondent prescribed D.K.M. Percodan. Over the next ten 
years, D.K.M. was involved in approximately five more car accidents 
with some requiring emergency room treatment. She was assaulted by 
patients during her work as a nurse and by her spouse on several 
occasions. In addition, she was injured lifting a heavy patient at 
work, her knees buckled several times causing her to fall, and she 
broke her ankle following a fall off a truck and later sprained the 
same ankle. During his treatment of D.K.M., Respondent regularly 
prescribed large quantities of various controlled substances. For 
example, between May 4, 1987 and January 20, 1988, Respondent 
prescribed D.K.M. 415 Percodan, 780 Tylenol No. 3 and 760 Vicodin. In 
April 1992, Respondent stated that his goal was to get D.K.M. off all 
medication by July 1992, yet he subsequently issued her a prescription 
for 100 hydrocodone with APAP with five refills.
    Respondent testified that it did not occur to him that D.K.M.'s 
accidents may have been related to her abuse of controlled substances, 
but that in retrospect, her multiple injuries were ``red flags.'' The 
Government's expert testified that none of D.K.M.'s accidents justified 
prescribing her the quantity of controlled substances that Respondent 
did and that people who are abusing medication frequently develop falls 
and injuries in an attempt to obtain more drugs. In addition, D.K.M. 
allegedly lost prescriptions, which according to the expert is further 
evidence of drug-seeking behavior. The expert opined that Respondent 
did not prescribe for D.K.M. for a legitimate medical purpose.
    Respondent began testing S.K. in April 1990. S.K. had significant 
motor weakness of both legs as a result of brain surgery, had severe 
scoliosis for which she had had a spinal fusion, and needed crutches in 
order to walk. She first saw Respondent complaining of neck pains and 
headaches. Respondent diagnosed S.K. as suffering from a cervical 
sprain. S.K. saw Respondent periodically until February 1993, suffering 
from continuing pain in the back, hip and groin, headaches and muscle 
spasms. Respondent prescribe S.K. various controlled substances and 
anti-inflammatories, and referred her for physical therapy. On two 
occasions, Respondent prescribed S.K. 100 Vicodin with 5 refills. 
Respondent testified that he prescribed S.K. such large quantities of 
Vicodin because he did not expect her condition to change quickly, that 
orthopedic conditions generally change slowly, and that pharmacists 
frequently encouraged him to prescribe in quantities of 100 because it 
is less expensive.
    Between June 5, 1989 and May 21, 1990, Respondent issued N.R. 29 
prescriptions (6 original prescriptions plus refills) for a total of 
1,690 Tylenol No. 3. N.R. was K.D.M's elderly mother and she suffered 
from advanced arthritis of multiple joints. N.R. was never officially a 
patient of Respondent's and he did not maintain a patient record for 
her. Respondent stated that he prescribed for N.R. as a favor and did 
not charge her. However, Respondent informed D.K.M. that if N.R. wanted 
prescriptions or treatment in the future she would ``have to become an 
official patient and be worked up thoroughly with x-rays and other 
tests, become `favors' cannot go on forever.'' The Government's expert 
testified that patent records are not only legally required but are 
necessary to establish a doctor-patient relationship, to determine the 
patient's progress or lack thereof, to determine how the patient will 
respond to treatment, and to protect the physician. It was the 
Government expert's opinion that the prescriptions issued to N.R. were 
not for a legitimate medical purpose.
    Respondent issued prescriptions to A.R. and C.R., the couple whose 
house was searched and were later arrested that was discussed above. 
Respondent did not offer any explanation for the controlled substance 
prescriptions issued to A.R. Regarding C.R., Respondent first treated 
him in June 1991 for lumbosacral sprain with radiculopathy stemming 
from various accidents in 1990 and 1991. Initially, Respondent ordered 
an MRI, and prescribed 60 Percocet, 100 Xanax with 5 refills, and 60 
Valium with 5 refills. In addition, C.R., dislocated his shoulder three 
times and fell causing more pain. During his treatment of C.R., 
Respondent prescribed large quantities of Percocet, Xanax and Valium, 
and prescribed Dalaudid for a period of time. For example, over a 117-
day period in 1991. Respondent prescribed C.R. 950 Valium or about 8.1 
pills per day. Between February 28 and March 25, 1992, Respondent 
prescribed C.R. 310 Percocet or about 11.5 pills per day. Respondent 
almost always issued new prescriptions before the supply from the 
previous prescription should have run out. On one occasion, Respondent 
issued C.R. a new prescription after C.R. indicated that he had spilled 
water on his Percocet causing the pills to dissolve. In addition, 
Respondent often postdated prescriptions for C.R.
    Notes in the patient file dated July 15, 1991, indicated that a 
pharmacist had called because C.R. was taking more Percocet that 
directed; that Respondent's partner refused to give C.R. more 
medication; and that the patient had two herniated discs, a dislocated 
shoulder and a bad knee and was in great pain and wanted Percocet 
before his next scheduled visit. Respondent testified that he ended his 
doctor-patient relationship with C.R. after the local police told him 
that they suspected that C.R. was a drug dealer and that he cooperated 
in the investigation. Respondent also testified that the local 
prosecutor wrote to him thanking him for his help in the investigation 
of A.R. and C.R.
    The Government's expert stated that in his opinion to a reasonable 
degree of medical certainty, C.R. was addicted to drugs, that 
Respondent maintained C.R. on controlled substances knowing that he was 
addicted to them, and that Respondent unlawfully attempted to detoxify 
a narcotic addict with narcotic medications by telling C.R. to cut down 
gradually on his use of these medications. The expert further stated 
that in his opinion, Respondent grossly deviated from the standard of 
care and the normal doctor-patient relationship by his prescribing to 
C.R. Respondent testified that he was ``lenient'' with C.R. and that 
C.R. was ``almost a waking red flag.''
    Respondent also treated C.R.'s brother, J.R. for a little over two 
years beginning in March 1991. J.R. was a garbage man with chronic 
lumbosacral sprain and a fracture in the lower back that could by 
itself require surgery and that resulted in other low back ailments to 
take longer to heal. During the course of his treatment, J.R. also 
suffered a number of accidents at work which further injured his back. 
J.R. needed to work to support his family. Respondent regularly 
prescribed J.R. Percocet and at various times also prescribed him 
Valium, Xanax and Darvocet. Respondent also referred J.R. for physical 
therapy. At one point, J.R. was seen by Respondent's partner who also 
prescribed J.R. Percocet.
    At some point during his treatment, J.R. told Respondent that he 
was a former addict, but felt that he needed the medication for his 
pain and not because he was addicted. The Government's expert stated 
that an x-ray report in J.R.'s file did not indicate any

[[Page 51597]]

condition that would cause sufficient pain to warrant treatment with 
Schedule II narcotics in the quantities and over the period of time 
that Respondent prescribed them.
    A review of the prescriptions issued by Respondent to J.R. also 
revealed a number of postdated prescriptions. Respondent testified that 
he postdated prescriptions for this patient when his office would be 
closed on the day the prescription would normally be issued, and that 
he understood at the time he issued these prescriptions that a 
pharmacist would not dispense them until the date written on them.
    The Government's expert stated that in his opinion, J.R. was 
addicted to drugs and that Respondent prescribed these drugs to him 
even though he knows or should have known that J.R. had no medical need 
for them. The expert further stated that Respondent did not take 
adequate histories or perform adequate physical examinations of this 
patient, that Respondent prescribed controlled substances to J.R. 
without seeing him, that the patient showed obvious drug-seeking 
behavior and that Respondent knowingly perpetuated J.R.'s addiction. 
Respondent testified that he did not think that he was lenient with 
J.R. and did not think that J.R. was a drug-seeking patient.
    B.S. was a nurse who first was Respondent's partner in August 1986 
after being injured at work. She became Respondent's patient in January 
1987 and was hospitalized that month. Over the next six and half years 
B.S. underwent surgery several times. In October 1992, an MRI revealed 
a large lesion destroying bone in her back which was probably caused by 
a bone infection. She subsequently underwent a nine hour surgery. In 
addition, she was involved in a car accident, fell down some stairs and 
had a severe asthma attack, all of which exacerbated her neck and back 
pain.
    Respondent prescribed B.S. various controlled substances over the 
years. On six occasions between January 7 and August 4, 1991, 
Respondent issued B.S. prescriptions for both Percocet and Demerol for 
a total of 260 Demerol and 390 Percocet. Following her last surgery, 
Respondent prescribed B.S. Dilaudid for approximately three and a half 
months. Over the years, Respondent referred B.S. to a spine specialist, 
a neurosurgeon, a neurologist and an infectious disease specialist.
    Respondent's records revealed that Respondent reissued 
prescriptions for Percocet to B.S. after her house was burglarized two 
times, the locker room at her work was robbed, her motel room was 
robbed while she was on vacation, she spilled some Percocet at a ball 
game, and her daughter threw some of the drugs away.
    The Government's expert opined that three and a half months is a 
long time for any patient to be routinely taking Dilaudid. The expert 
reported that Respondent issued prescriptions for Dilaudid to B.S. 
before her previous supply should have been exhausted, that Percocet 
and Dilaudid are not normally prescribed in combination, and that they 
both attach to the same receptor sites in the brain. He concluded that 
Respondent's prescribing to B.S. was irresponsible and a ``gross 
deviation from the standard of care in the practice of medicine in New 
Jersey, or in the United States.'' Respondent testified that he knew 
B.S. before he began treating her and that he thought she had personal 
integrity and would not be likely to divert controlled substances.
    Respondent began treating C.T. Sr. in 1978 for a knee injury. 
Respondent treated C.T. Sr. until 1990 for various problems including 
chronic should pain, cervical and lumbosacral sprain suffered as a 
result of a car accident, impingement in the shoulder, and pain 
following surgery on his shoulder and arthroscopic surgery on his knee. 
C.T. Sr. had a number of work-related accidents and injuries and was 
hit by a car. During his treatment of C.T. Sr., Respondent prescribed 
him various controlled substances for pain. Between 1984 and 1990, 
Respondent issued C.T. Sr. 208 Percocet prescriptions, even issuing two 
on the same day, one for 21 dosage units and the other for 20. 
Respondent admitted that after a while, he became suspicious of C.T. 
Sr.
    Respondent often issued C.T. Sr. controlled substance prescriptions 
before the supply from the previous prescription should have run out. 
Respondent admitted to this, but testified that he did so because 
patients' conditions change daily and the directions on the 
prescription represent the physician's ``best guess and estimate'' as 
to how often the patient should take the medication.
    Respondent began treating C.T. Sr's wife, D.T. in 1979 for pulled 
muscles and tendonitis of the knee and possible phlebitis. At one 
point, she was hospitalized and a neurologist diagnosed her as 
suffering from neuromuscular derangement syndrome. At a later point, 
D.T. had surgery for scar tissue and thereafter, surgery for a ganglion 
cyst and inflamed tendons of the left wrist. Over the years, Respondent 
prescribed large amounts of Percocet to D.T. On one occasion, C.T. Sr. 
called Respondent and told him that D.T. was suffering from severe back 
and knee pain, and Respondent issued her a Percocet prescription. 
Respondent testified that now he would recognize this as ``a rather 
blatant attempt to try and get some Percodan out of me.''
    Respondent issued D.T. prescriptions for Percocet before the supply 
from the previous prescription should have been exhausted, and would 
often issue new prescriptions after D.T. represented that she had lost 
a prescription. While Respondent believed that D.T. clearly had 
problems with her arm, he ultimately told her to go elsewhere because 
he was not able to cure her wrist and would not give her any more 
medication.
    According to the Government's expert, Respondent's prescribing to 
D.T. was not for a legitimate medical purpose. The expert stated that 
``[i]t is incomprehensible to think that this physician was not aware 
of the substance abuse by these patients.'' He further testified that, 
``If you don't see a patient and you get asked to fill prescriptions 
for a patient you haven't seen, and the wife is getting the same 
medicine and she's fabricating and exaggerating symptoms as he is, 
that's pretty obvious. I mean, that's not something that you would call 
gullibility.''
    Respondent also issued Percocet prescriptions to C.T. Sr.'s son, 
C.T. Jr., who was 12 years old when Respondent first began treating 
him. According to Respondent C.T. Jr. had had major injuries to his 
right hand five years before, and Respondent issued him prescriptions 
for flare-ups of severe pain. Respondent did not have any patient 
record for C.T. Jr., and Respondent indicated that C.T. Jr. was not 
really a patient of his, but that he issued him the prescriptions as an 
act of charity because the family could not afford to send C.T. Jr. to 
see his family physician. Respondent admitted that between July 6, 1985 
and February 3, 1990, he issued C.T. Jr. 11 prescriptions for a total 
of 370 dosage units of Percocet. Respondent testified that although 
C.T. Jr. was an adolescent, he was physically large so there was no 
physiological difference between him and an adult with respect to 
prescribing pain medication.
    Respondent stated that in retrospect, many of C.T. Jr.'s complaints 
were fabricated in order to please his parents who were addicted to 
Percocet. In one month Respondent prescribed to the father, mother and 
son a total of 369 dosage units of Percocet.
    Respondent first saw E.T. in 1981 when she was hospitalized with 
diabetes-associated problems. He did not see her again until 1985 when 
her

[[Page 51598]]

family physician referred her to Respondent because she was suffering 
from intractable diabetic neuropathy and she was taking large 
quantities of Percodan. Respondent continued to prescribe Percodan to 
E.T., authorizing 227 dosage units during a five week period in 1985. 
Ultimately, Respondent referred E.T. back to her family physician 
stating in a letter that, ``Since I have an [enormous] number of 
Percodan patient[s] myself, I request that you take this patient 
back.''
    A notation in E.T.'s patient file dated January 22, 1986, indicated 
that this was the last prescription and the patient was so advised. 
However Respondent issued her several more prescriptions for Percodan. 
On one occasion, E.T's husband called and indicated that his wife was 
in a lot of pain and requested that Respondent issue her a prescription 
for 25 Percocet to hold her until her next appointment.
    The Government's expert testified that E.T. and her husband were 
exhibiting drug seeking behavior, and that even if E.T. had painful 
diabetic neuropathy, she could have been treated with non-habit forming 
medications. The expert did not believe that there was a legitimate 
medical purpose for the drugs Respondent prescribed for E.T. because 
Respondent was treating this patient for a condition out of his area of 
expertise and he was ``simply prescribing controlled drugs for another 
doctor's patient.''
    Respondent began treating E.T.'s husband, J.T. in 1980 for multiple 
injuries sustained in a car accident in 1977 and for which J.T. had 
undergone three surgeries. When Respondent first saw J.T. he had an 
unhealed and draining fracture of his left leg and it was crooked so 
that he had been unable to walk for three and a half years. Respondent 
performed several operations on J.T.'s leg and prescribed J.T. mainly 
Percodan. As an example, Respondent prescribed J.T. 735 dosage units of 
Percodan between April 1 and August 26, 1982.
    Subsequently, J.T. fell, rupturing his Achilles tendon, and later 
sprained his left ankle and had surgery in New York. By 1986, J.T.'s 
left leg was worse and it was ultimately amputated in 1987 in New York. 
The doctors in New York prescribed J.T. MS Contin, so Respondent began 
prescribing him the drug. Thereafter, Respondent performed a procedure 
on J.T.'s leg since the wound was still draining. In addition, J.T. 
experienced severe phantom limb pain. Respondent continued to prescribe 
J.T. large quantities of MS Contin, even after J.T. appeared to be 
improving. Respondent referred J.T. to a detoxification center, but 
J.T. would not go for fear of losing his job. At some point later, J.T. 
was in a car accident where he injured both knees, his ribs, neck and 
lower back. Respondent referred J.T. to a neurosurgeon.
    Notes in J.T.'s patient file indicated that a neurologist 
recommended that J.T. be detoxified from MS Contin and a pharmacist had 
reported that J.T. was using Valium twice as fast as he should. 
Respondent nonetheless continued to prescribe J.T. MS Contin, Restoril, 
Percocet and Valium.
    The Government's expert noted that J.T. called Respondent's office 
to obtain prescriptions, sometimes stating that he had lost a 
prescription or requesting postdated prescriptions. The expert state 
that ``[t]hese tactics are such an obvious attempt of getting and using 
more pills than prescribed and it clearly points to the situation where 
the patient now is in control of the doctor rather than vice versa. * * 
* I do not believe, in this day and age, that any physician would be 
that blindfolded to the obvious drugs-seeking behavior.'' The expert 
noted that J.T. displayed the classic signs of a drug abuser, and 
concluded that Respondent's prescribing of the types and quantities of 
controlled substances to J.T. was not for a legitimate medical purpose.
    Respondent's expert did not testify in the proceedings before Judge 
Bittner, but his testimony before the Medical Board was admitted into 
evidence. The expert emphasized that there has ``never been promulgated 
clear-cut standards of care in the management of patients with chronic 
pain who require long-term narcotic medication,'' and that there is no 
law or regulation specifying how much narcotic medication a chronic 
pain patient may be prescribed. The expert testified that he was 
impressed by the ``medical and surgical complexity,'' of the patients 
at issue in that proceeding and that he concluded that Respondent's 
prescribing ``mostly does not deviate from the accepted [medical] 
standards,'' noting that Respondent documented reasons for his 
prescriptions, he followed the patients carefully over a long period of 
time and knew the cases well, there was no information of progressive 
deterioration related to the prescriptions during the time of the 
prescriptions, and that in all but a few cases, Respondent kept 
``fairly decent records.'' The expert testified that the only patient 
for whom Respondent's prescribing deviated from standard medical care 
was T.K.
    Although not required by the Medical Board, following the 
suspension of his medical license, Respondent underwent rehabilitative 
training in late 1993 or 1994 with a physician who is part of the 
Academy of Medicine of New Jersey, the educational arm of the New 
Jersey Medical Society. This physician is board certified in 
psychiatry, psychotherapy, and preventive medicine, and certified in 
addiction medicine.
    The training consisted of six or seven two-hour sessions over a 
four to six month period during which Respondent and the physician 
engaged in role playing exercises designed to help with the handling of 
drug seeking patients. They also reviewed the potency of medications, 
pain management techniques, how to obtain assistance in dealing with 
problem patients, and how to recognize ``red flags'' to warn of drug 
seeking patients. Respondent was given homework assignments and also 
read material outside of his sessions with the physician. Respondent 
passed an examination given at the conclusion of the training.
    Respondent testified that the course made him better able to handle 
controlled substances and to handle drug-seeking patients. He further 
testified that as a result of the course. ``I came to believe that I 
was an easy mark for patients. I was too believing in everything they 
said. I didn't try hard enough to decrease potentially habit-forming 
drugs in a number of cases. * * * Although, at the time I felt I was 
doing the right thing.''
    In retrospect and after his training, Respondent felt that in three 
or four cases, ``I over-prescribed, with good intentions, but I didn't 
act prudently in retrospect.'' He testified that he had become more 
suspicious than he used to be and that he believed that it is not 
necessarily incorrect to use controlled substances to treat chronic 
pain but that physicians have more alternatives to controlled 
substances in treating these patients now.
    At the hearing, Respondent acknowledged that he sometimes 
prescribed additional controlled substances to patients before their 
previous supply should have been exhausted, but testified that if a 
patient used up a supply of medication before it should have been 
exhausted if the directions for use were followed, then he would 
conclude that the patient had more pain than he thought. Respondent 
also testified that prescribing two narcotics simultaneously is 
justified when a physician thinks that the patient can be managed on 
the weaker drug but prescribes some of the stronger one in case the 
weaker one does not work. Prescribing the drugs at the same time saves 
the patient another trip to the physician's office if the weaker

[[Page 51599]]

medication does not provide relief. Respondent further testified that 
the issue of prescribing more than one controlled substance at a time 
``comes down to do you trust your patient. And I trusted my patient * * 
* I was too gullible in certain situations.''
    In this proceeding, Respondent was asked about his 1991 testimony 
before the Preliminary Evaluation Committee that, ``I'm a lot stricter 
and tougher about this than I was. I mean, as I look back I realize 
that I was really too lenient with all these people.'' Respondent 
testified at the hearing before Judge Bittner that he ``was more aware 
of red flags,'' that ``it was an evolving process,'' and that ``I am 
more aware today than I was last year.''
    Respondent offered into evidence affidavits from colleagues who 
stated that Respondent's medical treatment of his patients was 
professional, that he has demonstrated concern and compassion for his 
patients, that he is highly regarded, that he conducts himself in the 
best interests of his patients, and one stated that he had never 
observed Respondent engaging in any unethical conduct. An affidavit 
from a patient indicated that Respondent was dedicated to treating and 
improving her condition.
    In addition, Respondent offered into evidence the testimony of a 
colleague at the 1993 Medical Board hearing. The colleague testified 
that Respondent had an excellent reputation within the orthopedic and 
general medical communities and that Respondent's standard of care was 
above reproach. The colleague testified that in his opinion, Respondent 
``has exercised appropriate care and concern and appropriate management 
of [the patients at issue] prior to prescribing any given medication.'' 
He further stated that there could be reasonable differences of opinion 
among orthopedists as to the type and amount of medication to prescribe 
to a given patient. The colleague did testify however that he would not 
prescribe more than a four-week supply of Schedule II or III medication 
at one time and that he would ``definitely'' not prescribe narcotics 
for a patient without maintaining a patient record.
    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 public health 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 FR 16, 422 (1989).
    As to factor one, it is undisputed that Respondent's New Jersey 
medical license has been in effect since August 1994, and in October 
1994, the Medical Board permitted Respondent to resume prescribing 
controlled substances, if and when he is issued a DEA registration, 
subject to various restrictions for at least one year. The restrictions 
imposed by the Medical Board include that Respondent must maintain a 
log of his prescribing and dispensing; he may not prescribe or dispense 
more than a 14-day supply at one time to a patient; and he must refer a 
patient to a pain management specialist for a second opinion prior to 
completion of 90 days of prescribing or dispensing to the patient.
    Respondent argues that DEA is bound by the Medical Board's 
findings. The Acting Deputy Administrator rejects this argument since 
the recommendation of the state licensing authority is only one of the 
factors to be considered in determining whether Respondent's 
registration would be in the public interest. Like Judge Bittner 
states, ``[i]nasmuch as state authority to handle controlled substances 
is a necessary but not sufficient condition for DEA registration * * * 
this factor is not dispositive.'' However, the Acting Deputy 
Administrator does find it significant that after reviewing 
Respondent's treatment of the patients at issue, the Medical Board 
reinstated Respondent's license to practice medicine and his ability to 
handle controlled substances, albeit with restrictions.
    Regarding Respondent's experience in dispensing controlled 
substances, the Government does not dispute that during Respondent's 20 
years in practice he has seen over 15,000 patients. At issue in this 
proceeding is Respondent's controlled substance prescribing to 18 
patients.
    Judge Bittner concluded that Respondent issued controlled substance 
prescriptions to two individuals for no legitimate medical purpose. She 
found that Respondent did not offer any explanation for the fact that 
between August 22 and September 23, 1992, he prescribed 480 Vicodin to 
A.R. Judge Bittner stated that ``[w]hen a physician prescribes such an 
unusually large quantity of a controlled substance, it is reasonable to 
require him to show that the prescribing was for a legitimate medical 
purpose.'' Since Respondent did not provide any justification for these 
prescriptions, Judge Bittner inferred that they were not issued for a 
legitimate medical purpose. The Acting Deputy Administrator disagrees 
with Judge Bittner's conclusion. The burden of proof in these 
proceedings is on the Government, and the mere fact that Respondent 
prescribed A.R. a large quantity of a controlled substance in and of 
itself does not warrant the conclusion that there was no legitimate 
medical purpose for the drugs.
    Judge Bittner also found that there was no legitimate medical 
purpose for the Tylenol with codeine and gluethimide prescriptions 
Respondent issued to T.K. for approximately nine years. The Acting 
Deputy Administrator agrees with Judge Bittner's conclusion. In 1984, 
all New Jersey physicians were warned by a newsletter that ``[b]arring 
unusual circumstances, there would be no legitimate medical indication 
for the prescribing of the combination of Glutethimide and Codeine.'' 
In addition, the Government's expert noted in his report that ``there 
is no medical rationale for the use of this combination.''
    Regarding Respondent's prescribing to the other patients at issue, 
Judge Bittner found numerous examples of questionable conduct. 
Respondent prescribed various patients other combinations of controlled 
substances either simultaneously or within a short period of time. He 
issued prescriptions to individuals before the quantity obtained 
pursuant to previous prescriptions should have been exhausted. 
Respondent postdated prescriptions, and issued prescriptions despite 
expressions of concern by physicians, pharmacists or others about the 
quantity of medication the patients were obtaining. Respondent 
continued to prescribe controlled substances to patients even after he 
had indicated that he would stop issuing them

[[Page 51600]]

prescriptions. He ignored signs that patients were abusing the 
controlled substances prescribed or were at serious risk of doing so. 
For example, he continued prescribing to one individual even after 
learning that the individual had been altering earlier prescriptions. 
He also ignored the possibility that the multiple accidents and 
injuries reported by the patients could be drug-seeking behavior.
    Judge Bittner also found that ``Respondent failed to appropriately 
document his treatment and prescribing to a number of patients.'' 
Significantly, Respondent did not maintain any patient file whatsoever 
on two of the patients.
    Judge Bittner further found that ``Respondent's treatment of 
various patients also shows a regrettable lack of responsibility * * 
*.'' As examples, she notes that Respondent prescribed large quantities 
of certain drugs despite recommendations in the Physician's Desk 
Reference that they were not to be used for more than a few days; he 
continued to prescribe controlled substances to an individual after she 
overdosed; and he prescribed narcotics to an individual after learning 
that the individual had unsuccessfully attempted detoxification and was 
severely depressed.
    The Acting Deputy Administrator agrees that Respondent's 
prescribing to these patients appears to be highly questionable. 
However, the Acting Deputy Administrator is uncomfortable saying that 
Respondent's prescribing of large quantities of controlled substances 
or issuing new prescriptions before the previous supply should have 
been exhausted or prescribing combinations of controlled substances was 
improper given that these patients apparently had medical problems that 
caused chronic pain and warranted treatment.
    But, Respondent himself admits that he was too lenient regarding 
the treatment of some of the patients. In addition, the Medical Board, 
through its adoption of the state administrative law judge's findings, 
found serious problems with Respondent's prescribing of controlled 
substances. As the administrative law judge noted, ``* * * the patients 
in question had, to varying degrees, serious problems which no doubt 
may have resulted in legitimate pain complaints. The question, however, 
is one of degree. Respondent ignored obvious dangers of dependency, as 
evidenced in many instances by what were referred to by petitioner's 
witnesses as clear ``red flags'' which should have made him suspect. In 
addition, it is apparent * * * that [R]espondent did not have control 
of the dispensing of [controlled substances], but prescribed largely in 
response to communications and complaints from the patients in 
question, who frequently requested specific medications and dosages of 
medications, as well as specific dates for prescriptions.'' Further, 
the Medical Board noted in its 1994 order, ``while we do not condone 
the manner in which Dr. Caragine prescribed controlled dangerous 
substances to the patients who were the subject of this action, we do 
note that the vast majority of those patients were individuals with 
significant medical problems or illnesses requiring pain management.''
    The Acting Deputy Administrator also notes that the Government's 
expert, in his 1993 report, stated that

    At one point a doctor may be naive or even gullible but when 
patients continuously call the office for refills, lose their 
prescriptions, receive pharmacist's reports about refilling 
prescriptions frequently and knowledge of an individual's addiction 
by virtue of the fact that the doctor decided to wean them from the 
medication followed by continuous prescriptions, even after overdose 
situations, with more [controlled substances], can no longer be 
brushed aside as gullibility.

    Therefore, the Acting Deputy Administrator concludes that even 
though the patients at issue are only a small portion of Respondent's 
patient population, his prescribing of controlled substances to these 
individuals raises serious concerns regarding ability to responsibly 
handle controlled substances in the future.
    As to factor three, there is no evidence that Respondent has ever 
been convicted of charges under state or Federal laws relating to the 
manufacture, distribution or dispensing of controlled substances.
    Regarding factor four, pursuant to 21 CFR 1306.04, prescriptions 
for controlled substances may be issued only ``for a legitimate medical 
purpose by an individual practitioner acting in the usual course of his 
professional practice.'' As discussed above, the Acting Deputy 
Administrator finds that the prescriptions to T.K. for Tylenol with 
codeine and glutethimide were not issued for a legitimate medical 
purpose. Additionally, New Jersey law requires that physicians maintain 
patient charts for individuals that are prescribed controlled 
substances. It is undisputed that Respondent failed to maintain such 
charts for N.R. and C.T. Jr. Also, it is undisputed that Respondent 
postdated controlled substances prescriptions for various patients in 
violation of 21 CFR 1306.05, which requires that``[a]ll prescriptions 
for controlled substances shall be dated as of, and signed on, the day 
when issued. * * *''
    The Government alleged that Respondent detoxified patients without 
being registered to do so. However, the Acting Deputy Administrator 
agrees with Judge Bittner that the record does not support a finding 
that Respondent violated DEA regulations by conducting detoxification 
treatment without being registered to do so.
    As to factor five, Judge Bittner found ``Respondent's current 
assertions that he will be more responsible in the future are entitled 
to little weight.'' She noted that Respondent continued his 
questionable prescribing even after being interviewed in 1990 by a 
state investigator and after telling the Medical Board's Preliminary 
Evaluation Committee in 1991 that ``I'm very careful. I'm not so easy 
to get drugs out of like I use[d] to be,'' and that ``I want the board 
to know that I really made an effort to clean up my act and not be 
permissive.'' The Acting Deputy Administrator disagrees with Judge 
Bittner. In 1994, on his own initiative, Respondent underwent training 
to better equip himself to handle drug-seeking patients and to more 
responsibly handle controlled substances. Additionally at the hearing 
in this matter, when asked about his assurances at the 1991 hearing, 
Respondent testified that ``I'm a lot stricter and tougher about this 
than I was. I mean, as I look back I realize that I was really too 
lenient with all these people.'' He further testified that he ``was 
more aware of red flags,'' that ``it was an evolving process,'' and 
that ``I am more aware today than I was last year.''
    Judge Bittner concluded that even though ``the patients at issue 
here are a small fraction of the total number he treated over a twenty-
year period[,] * * * that most of these patients suffered chronic pain 
and that it was difficult to find appropriate treatment for many of 
them'' Respondent's prescribing ``is most charitably described as 
irresponsible.'' She further concluded that ``[n]otwithstanding 
Respondent's testimony that he will be more responsible in the future 
and that he is rehabilitated by his training * * *, it is clear that 
Respondent does not yet acknowledge his misprescribing.'' Therefore, 
Judge Bittner found ``that a preponderance of the credible evidence in 
this record establishes that Respondent's registration would not be in 
the public interest'' and she recommended that his application be 
denied.
    Respondent filed exceptions to Judge Bittner's Opinion and 
Recommended Ruling, and the Government filed a

[[Page 51601]]

response to Respondent's exceptions. The Deputy Administrator has 
carefully considered both of these filings in rendering his decision in 
this matter. First, several of Respondent's exceptions have already 
been addressed in this final order such as his argument that the 
Medical Board's ruling is binding on DEA, that the Government did not 
provide the records relied upon by its expert in rendering his opinion, 
and that Judge Bittner improperly found that Respondent prescribed 
controlled substances to A.R. for no legitimate medical purpose.
    Respondent also argued that Judge Bittner failed to consider 
Respondent's innocent unawareness of errors in judgment; the Medical 
Board's finding that Respondent had no improper motive in prescribing 
for his patients; the lack of evidence that Respondent knowingly and 
intentionally prescribed controlled substances to addicted persons or 
persons involved in illicit activity; the lack of evidence of any 
complaints about Respondent's prescriptive practices to any government 
agency by physicians, patients or staff; and the lack of evidence 
demonstrating that Respondent sold any drugs or prescriptions to 
anyone. The Acting Deputy Administrator concludes it is not necessary 
to prove that any of the above circumstances exist before a 
registration can be revoked or an application denied. Just because 
misconduct is unintentional, innocent or devoid of improper motivation, 
does not preclude revocation or denial. Careless or negligent handling 
of controlled substances creates the opportunity for diversion and 
could justify revocation or denial.
    Respondent argued that Judge Bittner failed to give proper weight 
to his previous treatment of patients other than those at issue in this 
proceeding, to the medical problems of the patients at issue, and to 
the fact that he voluntarily underwent training. Like Judge Bittner, 
the Acting Deputy Administrator has considered these facts and has 
given them the weight he deems appropriate in rendering his decision in 
this matter. Respondent further argued that Judge Bittner failed to 
even consider that he cooperated with state officials in their 
investigation of his patients. The Acting Deputy Administrator has 
considered Respondent's cooperation, however he does not deem it 
significant in determining whether Respondent can be trusted to 
responsibly handle controlled substances.
    Respondent also argued that the Government expert did not speak 
with or examine the patients at issue, nor did he speak with 
Respondent, his partner or office staff before submitting his report. 
The Acting Deputy Administrator finds that the expert could render an 
opinion without taking the steps outlined above, however in rendering 
his decision in this matter, the Acting Deputy Administrator has taken 
into consideration what was relied upon by the expert.
    Respondent further argues that Judge Bittner failed to find in 
Respondent's favor regarding specific points when ``DEA presented no 
evidence and the Respondent presented detailed, uncontradicted 
evidence.'' The Acting Deputy Administrator is unable to address this 
exception since Respondent did not provide any specific examples where 
this may have occurred.
    Respondent also contends that the Government did not establish that 
he knew or should have known that the combination of Tylenol with 
codeine and glutethimide is highly abused and that Judge Bittner was in 
error in finding that Respondent prescribed these drugs to be taken in 
combination. Respondent asserts that he prescribed these drugs 
separately and never told the patients to take them in combination. The 
Acting Deputy Administrator finds that it is incumbent upon a DEA 
registrant to keep abreast of the illicit uses of controlled 
substances. Here, as early as 1984, physicians in New Jersey were 
notified that barring unusual circumstances, there was no legitimate 
medical purpose for these drugs in combination. In addition, the Acting 
Deputy Administrator finds that it is of little significance that 
Respondent never actually told the patients to take the drugs together. 
By prescribing these drugs at the same time, he created the opportunity 
for abuse once the patient left his office.
    Respondent argues that Judge Bittner failed to consider a New 
Jersey regulation that was in place at the time of the prescribing at 
issue which addresses the prescribing of narcotic drugs for persons 
suffering from intractable pain. This regulation suggested that 
narcotics should be used after no other relief or cure can be found, 
that practitioners should be alert to new or alternative forms of 
treatment that may be less addictive, and that the practitioner should 
periodically either cease the medication, taper the dosage or try other 
medications in an effort to reduce the propensity for addiction. The 
Acting Deputy Administrator finds that Respondent's reliance on this 
regulation to justify his prescribing seems to be misplaced since 
Respondent did not appear to follow the suggestions set forth.
    Finally, Respondent argues that Judge Bittner failed to consider 
that the issuance of a registration limited to hospital patients only 
would be in the public interest and whether the Medical Board's 
restrictions would reduce or eliminate any potentially abusive 
prescriptive practices. These exceptions have been considered by the 
Acting Deputy Administrator and will be discussed below.
    The Acting Deputy Administrator is extremely concerned by 
Respondent's prescribing to the 18 patients at issue up until his 
medical license was suspended in 1993. While there may have been no 
improper motivation, Respondent ignored many ``red flags'' that should 
have alerted him to the possible abuse of controlled substances.
    But, the Acting Deputy Administrator notes that the patients at 
issue make up a very small percentage of Respondent's total patient 
population and that these patients had legitimate medical problems that 
warranted some form of treatment. In addition, the Acting Deputy 
Administrator recognizes that the events at issue occurred a number of 
years ago, and while passage of time alone is not dispositive, it is a 
consideration in assessing whether Respondent's registration would be 
inconsistent with the public interest. See Norman Alpert, M.D., 58 FR 
67,420 (1993). The Acting Deputy Administrator notes that following his 
state suspension, Respondent on his own initiative, underwent 
rehabilitative training to become better educated in controlled 
substances and how to deal with drug-seeking patients, and the 
restrictions imposed by the Medical Board on Respondent's handling of 
controlled substances will limit the chance for improper prescribing. 
Therefore, the Acting Deputy Administrator concludes that it is not in 
the public interest to deny Respondent's application for resignation.
    However, given the Acting Deputy Administrator's concerns about 
Respondent's past prescribing to the patients at issue, a restricted 
registration is warranted. This will allow Respondent to demonstrate 
that he can responsibly handle controlled substances in his medical 
practice, yet simultaneously protect the public by providing a 
mechanism for rapid detection of any improper activity related to 
controlled substances. See Steven M. Gardner, M.D., Docket No. 85-26, 
51 FR 12,576 (1986). For at least one year following the issuance of 
the DEA Certificate of Registration, Respondent shall be limited to 
handling

[[Page 51602]]

controlled substances for hospital in-patients only. This does not 
include emergency room handling of controlled substances since some of 
the prescriptions for the patients at issue in this proceeding were 
issued when they were seen by Respondent in a hospital emergency room. 
During that year, Respondent shall take a course in the proper handling 
of controlled substances. The Acting Deputy Administrator finds this 
necessary since Respondent received the training discussed in this 
proceeding approximately four years ago. At the conclusion of one year, 
or upon the submission to the Special Agent in Charge of the DEA Newark 
Field Division, or his designee, of evidence of completion of the 
course, whichever is later, Respondent can then handle controlled 
substances outside of the hospital in-patient setting with the 
restrictions ordered by the Medical Board. However, since the Medical 
Board's restrictions on Respondent's prescribing of controlled 
substances are to be in place for at least one year after he received 
his DEA registration, they are really of no consequence because 
Respondent is limited by DEA to only handling controlled substances for 
hospital in-patients. Therefore, for two years after Respondent is 
allowed to handle controlled substances outside of the hospital his 
registration shall be subject to the following conditions:
    (1) Respondent shall maintain a log of his prescribing, 
administering and dispensing of controlled substances and shall make 
this log available to DEA personnel upon request. At a minimum, the log 
shall include the name of the patient, the date the controlled 
substance is prescribed, administered or dispensed, and the name, 
dosage and quantity of the controlled substance prescribed, 
administered or dispensed.
    (2) Respondent may not prescribe or dispense more than a 14-day 
supply of a controlled substance at one time to a patient.
    (3) Respondent must refer a patient to a pain management specialist 
for a second opinion prior to completion of 90 days of prescribing or 
dispensing to the patient.
    According, the Acting 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 the 
application for registration submitted by Paul J. Caragine, Jr., M.D., 
be, and it hereby is granted subject to the above described 
restrictions. This order is effective no later than October 28, 1998.

    Dated: September 21, 1998.
Donnie R. Marshall,
Acting Deputy Administrator.
[FR Doc. 98-25827 Filed 9-28-98; 8:45 am]
BILLING CODE 4410-09-M