STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

AGENCY FOR HEALTH CARE ) ADMINISTRATION, BOARD OF ) MEDICINE, )

)

Petitioner, )

)

vs. ) CASE NO. 94-5411

)

SAMIR NAJJAR, M.D., )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, this cause came on for formal hearing before P. Michael Ruff, duly-designated Administrative Law Judge of the Division of Administrative Hearings, on September 26, 1996, in Jacksonville, Florida.

APPEARANCES

For Petitioner: Albert Peacock, Esquire

Agency for Health Care Administration Post Office Box 14229

Tallahassee, Florida 32317-4229

For Respondent: Bruce C. Lamb, Esquire

SHEAR, NEWMAN, ET AL.

Post Office Box 2378 Tampa, Florida 33601

STATEMENT OF THE ISSUES

The issue to be resolved in this proceeding concerns whether the Respondent is guilty of certain alleged violations of Section 458.331(1)(m), (q), and (t), Florida Statutes, concerning his

treatment of one patient during 1984 and 1985 and, if so, what penalty is warranted.

PRELIMINARY STATEMENT

This cause arose upon the filing of an Administrative Complaint on November 4, 1993 by the above-named Petitioner agency through its predecessor, the Department of Business and Professional Regulation. The Petitioner later filed a “notice of scrivener’s error”, without objection, to that complaint on April 29, 1996.

The Petitioner filed a Motion to Take Official Recognition of portions of Chapter 88-1, Laws of Florida, on September 24, 1996; and at the outset of the hearing on September 26, 1996, that motion was taken up and granted. The parties also had Joint Exhibit 1 admitted into evidence, and the Petitioner offered Petitioner’s Exhibit 1, a composite exhibit of licensure, registration documentation, and the Respondent’s application file from the Board of Medicine. The Respondent objected to that portion of the file which constitutes the Respondent’s application to become a licensed physician in Florida as to relevance, and that portion of the tendered exhibit was excluded. The parties stipulated to the admission of the licensure registration portion of that exhibit, and it was admitted as Petitioner’s Exhibit 1.

The Petitioner offered the deposition of Stephen M. Kreitzer, M.D., as its standard-of-care expert. The Respondent

stipulated to the admission of the deposition but objected to an exhibit to the deposition constituting a purported list of prescription information compiled by counsel for the plaintiff in the related civil action. The deposition was admitted as Petitioner’s Exhibit 2, except for that attachment, which was rejected as constituting hearsay and incompetent evidence.

The Petitioner offered Petitioner’s Exhibit 3, being a deposition of Brenda Church, custodian of records for Orange Park Hospital, with attached hospital records from that facility.

That exhibit was received without objection. The Petitioner offered Petitioner’s Exhibit 4, which was admitted by stipulation, being records of St. Vincent’s Hospital. A late- filed exhibit was offered by the Petitioner, consisting of the deposition of Robert E. Groble, M.D. That deposition was admitted, except for an attachment to that deposition consisting of a computer printout of prescription information, which was objected to and excluded.

The Respondent offered late-filed Exhibit 1, consisting of a deposition of Jeffrey Miller, M.D., which was admitted without objection. The Respondent also offered Respondent’s Exhibit 2, the curriculum vitae of the Respondent, as well as Respondent’s Exhibit 3, the curriculum vitae of Isabelle K. Sharpe, M.D., both of which were admitted without objection.

At the conclusion of the hearing, the Petitioner ordered a transcript of the proceeding; and the parties were given an

extended briefing schedule in which to file Proposed Recommended Orders. That schedule, as extended, resulted in Proposed Recommended Orders being timely filed by both parties.

FINDINGS OF FACT

1. The Respondent, Samir Najjar, M.D., is a licensed physician in the State of Florida, having been issued License No. ME0041782. He has been licensed as such at all times pertinent hereto. He received his medical degree from the University of Mexico in 1978. He performed an internship and residency in internal medicine at the Greater Baltimore Medical Center, completing that in 1981. He then completed a fellowship in pulmonary medicine at Wayne State University in Detroit, Michigan, in 1983. He is board certified in internal medicine and holds a Ph.D. in pharmacology and toxicology from Howard University in Washington, D.C.

2. Pharmacology is a specialized field of study in drug pharmacology. It includes the study of chemistry, the effects and uses of drugs, including their toxicology, the origin and nature of drugs, and the pharmacodynamics of drugs. A pharmacologist also studies the effects of drug combinations and their effects on various illnesses and on the body generally.

3. The patient involved in this proceeding is an adult male, who was born on March 4, 1950. He had a long history of reactive, obstructive airway disease, beginning at the age of 17 months to approximately 14 years of age. Between the ages of 14

   and 30, the condition alleviated substantially so that he only had very occasional shortness of breath, which could be treated with bronchodilator inhalers. In April of 1980, however, the patient suffered an acute onset of shortness of breath, which condition worsened. He was treated by physicians with a course of Prednisone, an oral steroid medication, for some two to three weeks. This was prior to his being treated by the Respondent.

4. The patient’s condition improved with the Prednisone therapy, but he experienced increasing shortness of breath one to two weeks after terminating that therapy. His shortness of breath become acute, resulting in a respiratory arrest and coma in May of 1980. The patient experienced a hypoxic seizure (lack of oxygen) and was hospitalized at St. Vincent’s Hospital in Jacksonville, Florida, for approximately seven days.

5. Between April of 1980 and July of 1984, he was hospitalized 12 to 15 times for exacerbations of the asthma condition. During this time, he required intubation, or the placing of a breathing tube in the trachea, due to respiratory arrest on three or four occasions, the last one being in December of 1983.

6. The patient has clearly been steroid dependent, with outpatient doses ranging from 5 milligrams four times per day of Prednisone to 35 milligrams twice per day of Medrol through September of 1984. Between July and September of 1984, the patient was receiving 35 milligrams twice per day of Medrol, also

   an oral steroid.

   
   

7. The patient was primarily treated by Edward A. Mizrahi, M.D., between June of 1984 and June of 1985. Dr. Mizrahi is an allergist in Jacksonville, Florida. Prior to that time, he was treated by Irwin Schneider, M.D., a pulmonologist in Jacksonville, Florida.

8. Upon initial presentation to Dr. Mizrahi, the doctor felt that the patient had severe steroid-dependent bronchial asthma with corticosteroid side effects. Patients who have life- threatening asthma are typically treated with anti-inflammatory medications, such as corticosteroids. Severe asthmatics can have life-threatening risks from their condition and will die, on many occasions, without the administration of steroid medications. Thus, such patients must take these medications to survive. Steroids have significant adverse side effects, including “cushinoid features”, development of cataracts and the development of osteoporosis. Despite such adverse side effects, the use of corticosteroids may be necessary in order to simply allow the patient to survive. The subject patient was in such a category.

9. The patient suffered from many of the side effects from long-term steroid use. Dr. Mizrahi noted compression fractures of the spine, cataracts, peptic ulcer disease, and weight gain during his initial evaluation of the patient on June 11, 1984; and on October 10, 1984, noted cushinoid appearance or features.

   This was before the patient was ever seen or treated by the Respondent.

10. On August 20, 1984, Dr. Mizrahi arranged for the patient to be evaluated at the National Asthma Center (Center) of the National Jewish Hospital and Research Center in Denver, Colorado. This is a specialty facility for the treatment of asthma and is commonly referred to as a “court of last resort”, where pulmonologists refer patients with difficult asthmatic conditions which have not as yet responded satisfactorily to treatment regimens.

11. Between September 12, 1984 and September 16, 1984, the patient was evaluated and treated at the Center. The Center noted the patient’s long history of severe asthma and resultant steroid dependency. Upon initial evaluation, the physicians at the Center felt that the patient would probably require continuing steroid therapy, but they did attempt to reduce the steroid dosage. The attempt to reduce the steroid dosage in the patient was unsuccessful, and the Center ultimately had to increase the steroid dosage.

12. The patient was discharged from the Center on an oral steroid medication, Medrol, 20 milligrams, alternating with 40 milligrams, four times per day. This is considered a high dose of steroid medication and was reluctantly arrived at and prescribed by the physicians at the Center after they made bona fide attempts to wean the patient from steroids to the extent

    possible.

    
    

13. During his hospitalization, the physicians at the Center noted that the patient gave a “convincing history for ischemic heart disease”. They suggested an investigation to determine the presence of this condition. Upon the patient’s return to Jacksonville, Florida, he continued to be treated by Dr. Mizrahi and continued to receive oral steroid medication in high doses. Additionally, he was receiving Halcion, Adivan, Fiorinal, and Fastin.

14. The Respondent first saw the patient on June 13, 1985 upon a referral from Dr. Samara, a urologist in Jacksonville, Florida, who had some contact with the patient. The Respondent took an extensive history from the patient, including a list of the current medications he was receiving from Dr. Mizrahi, which then included Medrol, 24 milligrams, four times per day, with a bolus of Medrol as needed of 60 milligrams four times per day for

    48 hours, followed by 30 milligrams four times per day for two weeks. The patient was also receiving Halcion at 0.25 milligrams at bedtime and Adivan at 2 milligrams.

15. The Respondent had the impression that the patient suffered from asthma and possibly from coronary artery disease. Due to the possibility of coronary artery disease, which had been raised during the admission at the Center, the Respondent hospitalized the patient from June 17, 1985 to June 22, 1985 at St. Vincent’s Medical Center in Jacksonville, Florida, to

    investigate the coronary situation.

    
    

16. During this hospitalization, an extensive history and physical were performed, including a neurological examination of the patient. A cardiac workup was performed by consulting cardiologist, Joel Ferree, M.D. This included a cardiac catheterization performed by Dr. Ferree, which indicated that the patient had normal right ventricular function, no significant arteriosclerotic lesions, and no significant artery response to adrenergic agonist agents. The cardiac catheterization reported normal left ventricular function. The cardiac catheterization report ruled out any cardiomyopathy.

17. During this hospitalization, the Respondent also ordered x-rays of the cervical and thoracic spine. The x-rays revealed “mild, old compression deformities of the eighth and ninth thoracic vertebral bodies, with no change since a previous examination on November 30, 1983”.

18. This x-ray report was consistent with the previously- reported compression deformities, or compression fractures, which are the result of osteoporosis. Osteoporosis leaves the bones weak, with loss of trabeculation. The patient’s vertebra were already being crushed as of June of 1985, when the Respondent undertook his care. At the time of discharge from this hospitalization, the Respondent recorded that he would like to wean the patient off steroids over several months.

19. The Respondent continued to treat the patient through

    April of 1989. During this period of time, the asthma was reasonably controlled with the use of steroid medications and bronchodilaters. Unlike the previous few years, the patient only required hospitalization for treatment of exacerbation of asthma symptoms on one occasion, on November 7, 1985. During this period of treatment, he never had a respiratory arrest and intubation was never required.

20. The Respondent would wean the patient from the use of steroids during this period of treatment when the symptoms allowed. When the symptoms were exacerbated, he would provide prescriptions for corticosteroids so as to address the patient’s condition. The Respondent made numerous attempts to wean the patient off high-dose steroid medication, but the patient’s condition would not permit a cessation of it.

21. The fact that the Respondent was unable to wean the patient from steroids is not surprising to physicians who treat such a condition. It is not a deviation from the accepted standard of care. The patient had a very significant case of asthma, which was life threatening, as demonstrated by the records of not only the Respondent, but the prior treating physicians. His asthma was so significant that he had to receive steroid medication, despite the significant side effects caused by such medication, in order to insure survival.

22. During the course of treatment, the Respondent also treated the patient for cervical strain and low-back pain. His

    compression fractures were a source of great pain, justifying the prescription of narcotic analgesics. The Respondent’s treatment for these conditions included physical therapy, paralumbar trigger point injections, biofeedback, TENS Unit, ice packs, as well as drugs, including muscle relaxants and analgesics. The Respondent also referred the patient for examination by orthopedic physicians and neurologists. These efforts were appropriate and within the standard of care. The prescriptions for Flexeril, Fiorinal, Lortab and Tylox and other medications for the control of back pain and muscle spasms were appropriate and under the circumstances of this severely-distressed patient, were within the standard of care.

23. The Respondent, on occasion, prescribed medications for control of insomnia, including Halcion. These same medications had previously been prescribed for the patient by Dr. Mizrahi for the same condition and were appropriate prescriptions. The corticosteroids and other medications used to control asthma can produce a side effect of insomnia. This manifestation must be treated for the benefit of the patient. The prescriptions for Halcion were appropriate and within the standard of care.

24. An additional side effect of steroid medication is weight gain. The Respondent advised the patient regarding dietary control for his weight to alleviate such a problem. The patient, however, exhibited substantial weight gain. Therefore, the Respondent prescribed a limited amount of Fastin, an appetite

    suppressant. Physicians must use medications such as Fastin with caution on patients with significant hypertension. The patient’s blood pressure, however, was not significantly elevated; and his blood pressure was being monitored during his use of Fastin. The use of Fastin by this patient did not cause a significant increase in his blood pressure.

25. Fastin is a sympathomimetic amine. It is not a true amphetamine. It is appropriately prescribed for weight control and this patient had exhibited an increase in weight, doubtless due to a side effect of the steroid medications. Increased weight in the patient was medically significant because he already had compression fractures of his vertebrae caused, no doubt, by osteoporosis, also attributable to side effects of steroid medications. Increased weight could exacerbate his skeletal problem and cause additional pain. Increased weight is also dangerous for patients with asthma, in any event, because it severely taxes the respiratory system and can make intubation, if necessary, more difficult. The Respondent’s prescriptions for Fastin were shown to be appropriate and within the standard of care, as demonstrated by the expert testimony of Dr. Miller and the other testimony in evidence offered by the Respondent.

26. During treatment of the patient, the Respondent prescribed Adivan also. Adivan is a muscle relaxing drug, and it was shown to be appropriately within the standard of care for physicians confronted with a patient with the multiple problems

    exhibited by this one. Although there can be some concern about mood alteration under certain circumstances with the use of Adivan and perhaps to some extent with Halcion, the Respondent did perform mental status examinations and referred the patient for evaluation when indicated. During his treatment of the patient, there was never any symptom of suicidal ideation expressed by the patient. There was no reason demonstrated which would justify the referral of the patient to a psychiatrist at an earlier date in the subject situation. The testimony of Dr.

    Miller and the other experts adduced by the Respondent shows that under the peculiar circumstances of this patient, the use of Adivan, as well as Halcion, in conjunction with the other medications the patient was taking, was medically justified and within the appropriate standard of care.

27. It has been demonstrated that the medical records maintained by the Respondent justify the course of treatment of the patient, as shown by testimony of record at pages 105 and 106 of the transcript of the proceedings and Respondent’s Exhibit 1 at pages 52-54. The Respondent practiced with that level of care, skill and treatment recognized as appropriate to meet the standard of care for similar physicians.

28. Upon weighing the expert testimony adduced by the parties, it is determined that the expert testimony presented by the Respondent was more persuasive and creditable than that presented by the Petitioner. The Petitioner’s expert, Dr.

    Kreitzer, relied upon some flawed information in developing his expert opinions, including, but not limited to, his reliance upon compilations of prescription information which was not established as accurate in the course of this proceeding, being merely computer printouts from records of pharmacists. Those records do not, for instance, even show that the Respondent prescribed all of those medications represented thereon. Dr.

    Kreitzer’s opinion was also flawed because his belief was based, in part, on his understanding that the patient was suffering from cardiomyopathy, when that condition had already been ruled out by cardiac tests performed upon the Respondent’s order during the June of 1985 hospitalization. Dr. Kreitzer’s mistaken belief that Fastin is an amphetamine, which it is not, also detracts from the weight which can be ascribed to his opinion. Further, Dr. Groble, the other expert presented by the Petitioner, cannot be relied upon because in his testimony he admits that he cannot render an opinion that the Respondent departed from appropriate standards of care in his practice with regard to the subject patient in the instances alleged in the Administrative Complaint because he had not seen all of the Respondent’s pertinent medical records. Consequently, he could not render a definitive opinion, one way or the other.

29. The Respondent’s expert witnesses, Dr. Miller and Dr. Sharpe, are accepted as more credible than the Petitioner’s expert testimony. Both Drs. Miller and Sharpe indicated that

    they had reviewed, in some depth, the medical records which the Respondent maintained concerning the patient and those records and the history pertaining to treatment rendered by other physicians and the Center. Their testimony revealed an in-depth study, reflection and consideration of the concededly large doses of multiple medications, some of which have significant side effects. They regrettably agree, that confronted with a complex, life-threatened patient, such as this, the Respondent could have done little else than follow the course of treatment and medication pattern and practice which he followed. While these experts and the Respondent, in the course of treatment, recognized the risks attendant to the engendering of dependency on the steroids and the use of the other medications, they acknowledged that under the circumstances there was little else that could be done in order to keep the patient stable, accord him some quality of life, and even to save his life.

30. In summary, it has not been established that the Respondent failed to adequately keep written medical records which justify the course of treatment of the patient. It has not been established that the Respondent prescribed legend drugs, including controlled substances, other than in the course of his professional practice, nor has it been established that he prescribed legend drugs in excessive quantities and in excessive combinations or, otherwise, inappropriately in relation to generally-accepted medical practice. It has not been established

    that the Respondent failed to practice medicine with that level of care, skill and treatment recognized by reasonably prudent similar physicians as being acceptable under similar conditions and circumstances.

    CONCLUSIONS OF LAW

    
    

31. The Division of Administrative Hearings has jurisdiction of the subject matter of and the parties to this proceeding. Section 120.57(1), Florida Statutes.

32. Section 458.331, Florida Statutes (1983) and (1985), provided, in pertinent part, as follows:

    The following acts shall constitute grounds for which the disciplinary action specified in (2) may be taken:

    * * *

    1. Soliciting patients, either personally or through an agent, through the use of fraud, intimidation, undue influence, or a form of overreaching or vexatious conduct. A solicitation is any communication which directly or implicitly requests an immediate oral response from the recipient.

       * * *

    2. Failing to keep written medical records justifying the course of treatment of the patient, including, but not limited to, patient histories, examination results and test results.

       * * *

       (q) Prescribing . . . a legend drug, including any controlled substance, other than in the course of the physician’s professional practice. For purposes of this paragraph, it shall be legally presumed that prescribing . . . legend drugs, including all controlled substances, inappropriately or in excessive or inappropriate quantities is not in the best interest of the patient and is not in the course of the physician’s professional practice, without regard to his

       intent.

       
       

       * * *

       (t) Gross or repeated malpractice or the failure to practice medicine with that level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances . . . .

       * * *

       2. When the Board finds any person guilty of any of the grounds set forth in (1), it may enter an order imposing one or more of the following penalties:

       1. Refusal to certify to the Department, an applicant for licensure.

       2. Revocation or suspension of a license.

       3. Restriction of practice.

       4. Imposition of an administrative fine not to exceed $1,000 for each count.

       5. Issuance of a reprimand.

       6. Placement of the physician on probation for a period of time and subject to such conditions as the Board may specify, including, but not limited to, requiring the physician to submit to treatment, to attend continuing education courses, to submit to re-examination, or to work under the supervision of another physician.

33. The Respondent has been charged with a violation of Section 458.331(m), Florida Statutes. It is clear, however, that the Petitioner intended to charge the Respondent with a violation of Section 458.331(1)(n), Florida Statutes (1983) or (1985), which has since been re-numbered as Section 458.331(1)(m), Florida Statutes.

34. The case of Ferris v. Turlington, 510 So.2d 292, 294 (Fla. 1987), and Robertson v. Department of Professional Regulation, Board of Medicine, 574 So.2d 153, 154 (Fla. 1st DCA 1990), stand for the principle that the prosecuting agency must

    establish the factual allegations made against a physician by clear and convincing evidence.

35. The admissible evidence in this proceeding, which supports the above Findings of Fact, shows that the Petitioner failed to prove clearly and convincingly that the Respondent violated any of the provisions of Section 458.331(1), Florida Statutes, charged in the Administrative Complaint. In fact, the Petitioner has failed not only to show clear and convincing evidence but to show preponderant evidence of any of the charged violations. That is, in none of the particulars charged in the allegations of the Administrative Complaint was it shown that the Respondent failed to practice medicine with the level of care, skill and treatment ability recognized as required of reasonably prudent, similar physicians when confronted with similar conditions and circumstances to those confronting the Respondent with this severely ill, chronic patient.

36. It was not established that the Respondent failed to keep medical records which justify the course of treatment accorded to that patient. In fact, the evidence adduced by the Respondent is the most substantial in this case, in establishing that the course of treatment and care followed, and the medical records kept justifying that course of treatment, was appropriate. Thus, it has not been established by clear and convincing or even preponderant evidence that the Respondent failed to comply with the statutory provisions he is charged with

violating.

RECOMMENDATION

Based upon the foregoing Findings of Fact and Conclusions of Law, it is

RECOMMENDED that a Final Order be entered by the Board of Medicine dismissing the Administrative Complaint in its entirety.

DONE AND ENTERED this 5th day of February, 1997, in Tallahassee, Florida.

P. MICHAEL RUFF

Administrative Law Judge

Division of Administrative Hearings The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-3060

(904) 488-9675 SUNCOM 278-9675

Fax Filing (904) 921-6847

Filed with the Clerk of the Division of Administrative Hearings this 5th day of February, 1997.

COPIES FURNISHED:

Albert Peacock, Esquire

Agency for Health Care Administration Post Office Box 14229

Tallahassee, Florida 32317-4229

Bruce D. Lamb, Esquire SHEAR, NEWMAN, ET AL.

Post Office Box 2378 Tampa, Florida 33602

Dr. Marm Harris, Executive Director Board of Medicine

Agency for Health Care Administration 1940 North Monroe Street

Tallahassee, Florida 32399-0770

Jerome W. Hoffman, General Counsel Agency for Health Care Administration 2727 Mahan Drive

Tallahassee, Florida 32308-5403

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions within 15 days from the date of this Recommended Order. Any exceptions to this Recommended Order should be filed with the agency that will issue the Final Order in this case.

Docket for Case No: 94-005411

Orders for Case No: 94-005411