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

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