STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF PROFESSIONAL ) REGULATION, BOARD OF OSTEOPATHIC ) MEDICAL EXAMINERS, )

)

Petitioner, )

)

vs. ) CASE NO. 83-2749

)

M. J. WARHOLA, D.O., )

)

Respondent. )

)

RECOMMENDED ORDER

After notice to the parties, a hearing was held in this case before Arnold

1. Pollock, a Hearing Officer with the Division of Administrative Hearings, in Tampa, Florida, on January 24, 1984. The issue for consideration was whether Respondent's license to practice osteopathic medicine in this state should be disciplined because of the alleged misconduct contained in the Administrative Complaint filed herein by Petitioner.

   
   

   APPEARANCES

   
   

   For Petitioner: James H. Gillis, Esquire

   Department of Professional Regulation

   130 North Monroe Street Tallahassee, Florida 32301

   
   

   For Respondent: Gerald W. Nelson, Esquire

   4950 West Kennedy Boulevard, Suite 603

   Tampa, Florida 33609 BACKGROUND INFORMATION

   Petitioner, Board of Osteopathic Medical Examiners, filed an Administrative Complaint in this case against Respondent, Dr. M. J. Warhola, on August 9, 1983, in which it was alleged that, in summary, as to two separate patients, during the years 1979 and 1980, Respondent was guilty of malpractice, or the failure to practice his profession with that degree of care and skill recognized by a reasonably prudent similar professional as being acceptable under similar conditions and circumstances in violation of Section 459.015(1)(t), Florida Statutes (1981). Respondent, by Election of Rights filed shortly thereafter, disputed the allegations in the Administrative Complaint and requested a formal hearing under Section 120.57(1), Florida Statutes (1981).

   
   

   At the hearing, Petitioner voluntarily moved to amend the Administrative Complaint by:

   
   

   1. at paragraph 8 - striking the word "metabolic."

   2. at paragraph 9 - striking the word "benzathiazine."

   3. striking in its entirety paragraph 22, and

   4. striking all of paragraph 23, after the word "justification."

These amendments were approved by the Hearing Officer.

Thereafter, Petitioner called Dr. Jeffrey L. Miller, Pearl Knowles, Dr. Mark Stern, Deborah A. Brown, Morton Cohen, Dr. Gordon Rafool, and Clifton M. Wood and introduced Petitioner's Exhibits 1-11. Respondent testified in his own behalf, called Joan E. Zacchini, and introduced Respondent's Exhibit A.

At the close of Petitioner's case, Respondent moved to dismiss certain portions of both counts of the Administrative Complaint. The Hearing Officer declined to rule on the motion at the time, indicating the ruling as appropriate on the state of the evidence would be in the form of Findings of Fact contained in the Recommended Order.

FINDINGS OF FACT

1. At all times pertinent to this hearing, Respondent, M. J. Warhola, was a doctor of osteopathic medicine and properly licensed as such by the State of Florida by license number OS 0001256, issued in 1957. He has been practicing osteopathic medicine at his present location in Tampa, Florida, for the past 17 or 18 years.

   
   

2. Respondent first started treating Pearl O. Knowles in 1965. Generally, she was suffering from severe diabetes and was overweight. He also, over the years, treated her for arteriosclerosis. Among the drugs he was prescribing for her during the 1979-1989 time period were Placidyl (sleeping pill), Verstran (tranquilizer), Triavil (antidepressant), Dilantin (anticonvulsant) Teldrin (antiallergenic), Donnatal (sedative), Synalgos (painkiller), Talwin (painkiller), various antibiotics, and such other substances as insulin, stool hardeners, vitamins, diuretics, antihistamines, and antiemetics. During the period from January, 1979, through December, 1981, prescriptions written by Respondent for these varying medications for Mrs. Knowles or her husband were filled by area pharmacies in accordance with the following chart:

   
   

   MONTH/YR	TOTAL	MRS. K	MONTH/YR	TOTAL	MRS.	K
   Jan. 79	11	4	July 80	22	15
   Feb. 79	15	7	Aug. 80	15	10
   Mar. 79	10	5	Sept.80	26	19
   Apr. 79	14	11	Oct. 80	20	10
   May 79	13	10	Nov. 80	21	16
   June 79	10	8	Dec. 80	22	17
   July 79	11	6	Jan. 81	16	11
   Aug. 79	15	10	Feb. 81	15	12
   Sept.79	13	10	Mar. 81	25	17
   Oct. 79	15	6	Apr. 81	26	17
   Nov. 79	7	5	May 81	21	10
   Dec. 79	17	12	June 81	11	4
   Jan. 80	12	8	July 81	23	8
   Feb. 80	17	12	Aug. 81	25	23
   Mar. 80	21	17	Sept.81	5	5
   Apr. 80	17	14	Oct. 81	20	14
   May 80	24	22	Nov. 81	4	2
   June 80	27	21	Dec. 81	2	2
   TOTAL:				588	400

3. Many of the above instances are refills of the same prescription. According to Respondent, some prescriptions were authorized five refills without contact with him. Some, such as Prescription #27162 for 100 Triavil, initially filled on December 1, 1979, was subsequently refilled at least 11 times, and three other separate prescriptions for the same drug were filled multiple times.

   
   

4. From January, 1979, through September, 1980, a period of 20 months, 30 tablets each prescriptions for Placidyl tablets, written by Respondent for Mrs. Knowles, were filled 46 times for a total of 1,380 tablets. During the same period, Triavil prescriptions for 100 capsules each written by Respondent for Mrs. Knowles were filled 22 times for 3,200 tablets, Talwin at 100 tablets 13 times for 1,300 tablets, at least 10 prescriptions for either Tylenol #3 or Fiorinol #3, both with codeine, at 50 tablets each for the Fiorinol at least totalling more than 509 tablets, as well as all the others stated in paragraph 2 above.

   
   

5. Mrs. Knowles admits taking too much medication, but claims it is not the fault of Respondent. Whenever Respondent saw her and gave her a prescription for any medicine, he would tell her what dosage to take. She would see the Respondent every two or three weeks and get a new prescription each time and would also give her prescriptions at her request without her going to the office personally. Regardless of what instructions Respondent would give her concerning the dosage of the various painkillers and "nerve medicines" he would give her, she often exceeded the directed dose either by accident or in an effort to relieve the extreme pain she was experiencing in her hands and feet. Not only did she get drug prescriptions from Respondent, but by her own admission, she also saw other doctors during the period from whom she got "pain pills," as well as taking those given to her on her release from the hospitals to which she was admitted. She recognized that she was taking too many drugs at the time, but the pain was severe and she felt it was required.

   
   

6. During this same period of time, from mid-1979 on through early 1982, while Mrs. Knowles was seeing Respondent for her diabetes and other chronic ailments, she was admitted to several hospitals in the area. On June 11, 1979, she was admitted to the Brandon Community Hospital (BCH) in Brandon, Florida (Brandon is a small community east of Tampa), in a confused and disoriented state. The admission diagnosis was diabetes with electrolyte imbalance. The attending physician noted at the time that the patient "is somewhat dependent on drugs."

   
   

7. Approximately two months later, on August 15, 1979, Mrs. Knowles was again admitted to BCH, this time for uncontrolled diabetes and overdosing her drugs including Placidyl and Fiorinol. Again, the attending physician noted the failure of the patient to take care of her diabetes, her drinking, and her drug dependency.

   
   

8. Mrs. Knowles thereafter stayed out of the hospital for about a year until, on September 1, 1981, she was again admitted to BCH, again for her diabetes. Secondary diagnoses on this occasion were hypertension and taxciencephalopathy, a disorder of brain function. At this time, she was seen in the hospital by Dr. Mark Stern. Based on the lab work performed and examination by Dr. Stern and other specialists to whom she was referred, it was concluded that her condition, aside from the diabetes and hypertension, was related to her overuse of drugs such as Talwin, Valium, Triavil, and the like.

9. She was again seen by Dr. Stern at BCH on October 24, 1981, when she was admitted for an unintentional drug overdose. A drug screen done at the time of admission revealed a Placidyl level of 69.4 (normal level is 0.5 to 10, with toxic levels being greater than 20). A repeat test six and a half hours later showed the level of Placidyl at 62.4. Other lab tests showed opiates, benzodiazepan (tranquilizers such as Valium and Librium), and salecylates. When she was admitted on this occasion, she had with her a box containing several medicine bottles. Notwithstanding Petitioner's allegation that "Said labels were not labeled by Respondent," the testimony of Deborah Ann Brown, Director of Pharmacy at BCH, to whom the box of bottles was given for identification, shows that only one of all the bottles did not have the appropriate markings on it.

   It also appears that some of the medicines in the box had been prescribed for Mrs. Knowles' husband, Ira.

   
   

10. Dr. Stern again saw Mrs. Knowles when she was brought to BCH on January 6, 1982, complaining of weakness and difficulty in walking. Again, her history showed she was taking antidepressants and Placidyl for chronic insomnia. Dr. Stern recalls that Mrs. Knowles telephoned him on October 9, 1981, and requested prescriptions for Placidyl, Triavil, and Talwin, but he refused to prescribe them for her. He terminated his relationship with her in August, 1982. During the period she was his patient, however, he did prescribe for her such substances as painkillers, sleeping pills, and antianxiety drugs, the same generic types of drugs as prescribed by Respondent, by written prescriptions, some of which called for multiple refills. Though Mrs. Knowles advised Dr. Stern that she was being treated by Dr. Warhola, Dr. Stern did not discuss her with Dr. Warhola or even contact him. Even when Mrs. Knowles threatened to get drugs from Respondent when Dr. Stern refused to give her prescription over the phone in October, 1981, Dr. Stern still did not contact Dr. Warhola.

    
    

11. Between the fourth and fifth BCH hospitalizations, on December 21, 1981, Mrs. Knowles was admitted to Tampa General Hospital (TGH) and was examined by Dr. Jeffrey L. Miller, a rheumatologist internist, at the request of her regular physician, Dr. Sugarman. When Dr. Miller first saw her, Mrs. Knowles was overmedicated. She was confused, and her speech was slurred. She indicated to Dr. Miller that she was taking Triavil and other drugs as well, such as Zomax and Placidyl, but refused to tell him all the drugs she was taking. Those she mentioned are addictive, and it appeared that she was addicted because she had been hospitalized for nonaccidental overmedication and because her condition was consistent with addiction. Mrs. Knowles denied having a drug problem.

    
    

12. In Dr. Miller's opinion, however, Mrs. Knowles was not receiving the proper therapy. Her diabetes did not require the drugs she was getting. Her other symptoms, in his opinion, did not justify the apparent liberal prescriptions she was getting and should have been treated with psychotherapy rather than drugs. In his opinion, therapy should be tailored for an individual like Mrs. Knowles so that the medication is limited and regulated to prevent addiction and the buildup of tolerance to a drug, which results in larger and larger doses.

    
    

13. The evidence also shows, however, that Mrs. Knowles was a difficult patient. Dr. Sugarman was having difficulty with her and requested the consult by Miller. What must also be considered is that Mrs. Knowles' leg, about which she constantly complained of the pain, was subsequently surgically removed in 1982 as a result of her diabetes. The pain associated with this condition leading up to the amputation was real and required relief to some degree. In any case, Dr. Miller did not ever discuss Mrs. Knowles with Respondent or advise him of her addiction.

14. Mrs. Knowles still receives painkillers and "nerve medicine" from her current physician, Dr. Sugarman, whom she sees every two weeks. She stopped seeing Dr. Warhola when she started seeing Dr. Sugarman, who, she felt, was more current in some of her problem areas than Respondent. She did not leave Respondent because she was dissatisfied with him. In fact, he was the only one who helped her blood clots. According to Respondent, he gave Mrs. Knowles the Placidyl for sleep because she had a lot of pain as a result of her diabetes and needed it to help her sleep. At this same time, Mrs. Knowles' husband was a severe alcoholic and, since she was under a lot of strain because of that, he gave her the drug to help her sleep. The call he got from Dr. Stern on October 26, 1981, when she was in BCH, indicating she was mixing drugs, was the first indication he had that she was abusing drugs. He told Stern she was not to get any more, and he, Respondent, has not prescribed any for her or seen her since. In fact, he was not informed of her hospitalizations in June or August, 1979, or in September, 1981. It is, even by the testimony of Petitioner's expert, Dr. Gladding, not uncommon in Florida for M.D.s to admit a D.O.'s patient to a hospital and not ever notify the D.O. of that fact.

    
    

15. Mrs. Clifton M. Wood of Winter Haven, Florida, was first taken to see Respondent for a diet regimen in 1980. On the first visit on February 7, 1980, he gave her a physical examination which included a complete laboratory workup, cardiogram, and weight and pressure check. He gave her some pills which had instructions for use on the bottle, but did not tell her what they were. Each time she came to his office for a visit thereafter, on a monthly basis, either Respondent or his nurse would weigh her and take her blood pressure and adjust her medication as required. During the course of treating Mrs. Wood, Respondent gave her phedymetrazine, an appetite suppressant, methahydrine for high blood pressure, Donnatal, and vitamins and minerals. He gave Mrs. Wood only the drugs he felt she needed in the amount she needed.

    
    

16. Mrs. Wood was admitted to Winter Haven Hospital on October 26, 1980, because a neighbor who was concerned about her brought her in. At the time, Mrs. Wood had trouble with dizziness, her balance, and falling. Before this incident, however, Respondent on one or more of his visits, had given her pills for her blood pressure and potassium pills for her to take in water.

    
    

17. According to Dr. Gordon Rafool, who had also treated Mrs. Wood since 1979 and who admitted her to the hospital in October, 1989, at the time of admission, she was, among other things, dehydrated and had an electrolyte imbalance (lack of body salt, specifically potassium), the latter possibly being caused by the intemperate use of a diuretic. A diuretic is often used in cases of heart failure, high blood pressure, and, though not recommended, weight reduction, to get rid of body water. Since it was important to know what medicines Mrs. Wood was taking to help determine the reason for her condition, Dr. Rafool and other hospital personnel tried to get an identification of the drugs in Mrs. Wood's possession when she was brought in. The hospital pharmacy could not identify them, and no drug screen was done, but Dr. Rafool obtained a written authorization of Respondent to permit Respondent to release any information regarding drugs dispensed or prescribed to the patient by him. This authorization was forwarded to Respondent's office with a request for Mrs. Wood's medical records, but they were never released.

    
    

18. Dr. Warhola's office manager, Mrs. Zacchini, states the request and authorization on Mrs. Wood were received, but were apparently inadvertently filed in the office record without the requested records being sent out. Though Dr. Rafool says that numerous follow-up calls were made to Respondent's office,

    Mrs. Zacchini denies any were received from either the hospital or Dr. Rafool. In any case, there is no evidence to indicate any calls were made to or received by Respondent directly, and he denies every having received any.

    
    

19. Mrs. Wood still considers Respondent to be a good doctor, but she has not gone back to see him since her release from the hospital because Dr. Rafool told her to stay away from him. She has been seeing Dr. Rafool, who has been treating her with pills for her arthritis and high blood pressure.

    
    

20. Petitioner presented the deposition of Dr. Lloyd D. Gladding, D.O., over the partial objection of Respondent, whose objection was not to the use of the deposition, but to specific parts thereof based on particular grounds. For example, Respondent objected to Dr. Gladding's testifying as an expert because, he contended, there had been no showing by Petitioner that the witness's experience compares to that of Dr. Warhola. He contends the witness does not practice in the same geographical area nor is there a showing he is a similar health care provider with a similar specialty or a similar type practice. However, Dr. Gladding's curriculum vitae, admitted without objection, shows he is currently co-chairman of a family practice seminar in his area and a clinical preceptor (teacher) at an osteopathic medical school and has been engaged in a family practice in the Fort Myers area since 1978. This area is geographically not far removed from the Tampa Bay area (the distance is not significant) and there is no showing that the patient conditions involved in the two cases at issue would or could be affected significantly by the geographical location of the patient or that treatment of these conditions varies greatly from location to location. In fact, according to this witness, he finds patients from widely differing areas (Pennsylvania, where he was trained, as opposed to Florida, where he practices) to be the same.

    
    

21. Accepting the witness as an expert, then, with reference to Mrs. Knowles and her condition, he has had patients with a similar series of health problems where the patient was placed on multiple drug regimens. Sometimes, these patients developed drug dependencies for the different medications he prescribed. In the case of Mrs. Knowles, based on the number of Placidyl prescribed by the Respondent over about a year, she received enough to take two per day, which would constitute 1,500 mg. of the drug per day (two tablets of 759 mg. each). The drug company's recommended daily dose is between 590 and 750 mg. given at bedtime, with an additional 109 to 200 mg. later on, if needed.

    The fact that Mrs. Knowles was also getting other drugs, including a different type of sleeping pill, makes Dr. Gladding feel the prescriptions by Respondent were excessive.

    
    

22. He admits, however, he does not know how much pain the patient was in and this makes it difficult to render an opinion. Because of this, he cannot unequivocally say that the dosage prescribed was excessive. Good practice is to prescribe as few Schedule II drugs as is possible. However, without knowing the patient, her attitude, and her actual condition, an opinion as to the appropriateness of the drugs prescribed, unless clearly inappropriate, would be merely guesswork.

    
    

23. As to the patient Mrs. Wood, Dr. Gladding could not read Dr. Warhola's notes of what drugs he gave her. Therefore, in analyzing Respondent's prescriptions, he relied on and referred to a federal drug analysis of the unmarked drugs she got from Respondent as including barbiturates or their derivatives. This analysis was not introduced into evidence, and Dr. Gladding's reference to it is hearsay which cannot, by itself and without other independent evidence of the identity of the drugs, support a finding of fact even though it

    would appear some were drugs that would not be used in weight control. However, there were drugs identified independently, such as the potassium replacement and the weight reduction drug, which were appropriate and, in addition, the tranquilizer could also be appropriate. In any case, Dr. Gladding does not know what Mrs. Wood told Respondent about the problems she was having sleeping. If she did tell him this, even the barbiturates could be appropriate.

    
    

24. Dr. Gladding has also been confronted with a situation where a patient of his has been hospitalized and the hospital calls him for information on the patient on an emergency basis. He knows, he says, everyone in the local hospitals and generally provides the requested information on the spot without a formal release. He is more concerned with the patient's welfare than with technicalities. However, in the case of Mrs. Wood, there was not an emergency situation and there was no showing Respondent was ever personally contacted. In addition, there was evidence of only one written release, not three, as reflected by the witness.

    
    

    CONCLUSIONS OF LAW

    
    

25. The Division of Administrative Hearings has jurisdiction over the parties and the subject matter of the proceedings.

    
    

26. In both Count I and Count II, Respondent is alleged to be guilty of gross or repeated malpractice, in violation of Section 459.015(1)(t), Florida Statutes (1981), which provides for disciplinary action to be taken for:

    
    

    (t) Gross or repeated malpractice or the failure to practice osteopathic medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar osteopathic physician as being acceptable under similar conditions and circumstances. The board shall give great weight to the provisions of s. 768.45 when enforcing this paragraph.

    
    

27. In a matter as grave as license revocation proceedings, the duty allegedly breached by the licensee must appear clearly from applicable statutes or rules or have a "substantial basis," Bowling v. Department of Insurance, 394 So.2d 165, 173 (Fla. 1st DCA 1981), in the evidence. Disciplinary license proceedings like the present case are potentially license revocation proceedings, even in the absence of a recommendation of revocation, since the penalty for the infraction lies within the discretion of the disciplinary authority, within the parameters of Section 459.015(2), Florida Statutes (1981), if allegations of misconduct are established at the hearing. Florida Real Estate Commission v. Webb, 367 So.2d 201 (Fla. 1979).

    
    

28. At the hearing, Petitioner had the burden to show by clear and convincing evidence that Respondent committed the acts alleged in the Administrative Complaint. Walker v. State, 322 So.2d 612 (Fla.3d DCA 1975); Reid v. Florida Real Estate Commission, 188 So.2d 846 (Fla. 2d DCA 1966). See The Florida Bar v. Ragman, 238 So.2d 594 (Fla. 1970).

    
    

29. There can be little doubt from the evidence that the Respondent did in fact do what is alleged in the factual allegations of the Administrative Complaint, as amended. However, the issue in both counts is whether those actions in either case constitute gross or repeated malpractice or the failure

    to practice osteopathic medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar osteopathic physician as being acceptable under similar conditions and circumstances. Here, it cannot fairly be said that it did.

    
    

30. Petitioner's own expert, Dr. Gladding, stated that while the amount and diversity of drugs provided for Mrs. Knowles by Respondent might have seemed excessive, based on the fact that he did not know the patient or how difficult she was, that he did not know her level of pain, and other like facts, he could not state that Respondent's prescribed regimen was inappropriate. Further, he admitted that in Florida, it is not at all uncommon for M.D.s to fail to give

    D.O.s the courtesy of information about their own patients.

    
    

31. As to Mrs. Wood, again, Dr. Gladding could not conclusively state that Respondent's course of treatment was malpractice. Add to that that both patients were satisfied with Respondent's treatment of them, and one can only conclude that the state of the evidence introduced here is not so strong, so conclusive, or so persuasive as to constitute a showing of misconduct sufficient to support disciplinary action.

    
    

32. It may well be that Respondent has been less than totally correct in his practice of dispensing drugs and that his attention needs to be drawn to that. However, conclusively, disciplinary action is not appropriate here.

    
    

33. The Petitioner has submitted a Proposed Recommended Order which includes proposed findings of fact and conclusions of law. The proposed findings and conclusions have been adopted only to the extent that they are expressly set out in the Findings of Fact and Conclusions of Law above. They have been otherwise rejected as contrary to the better weight of the evidence, not supported by the evidence, irrelevant to the issues, or legally erroneous.

RECOMMENDATION

Based on the foregoing, it is, therefore, RECOMMENDED:

That the Administrative Complaint filed herein against Dr. Warhola be dismissed, but that he be officially reminded of the necessity to conservatively prescribe controlled substances in the course of his practice.

RECOMMENDED this 6th day of March, 1984, in Tallahassee, Florida.

ARNOLD H. POLLOCK

Hearing Officer

Division of Administrative Hearings The Oakland Building

2009 Apalachee Parkway

Tallahassee, Florida 32301

(904) 488-9675

Filed with the Clerk of the Division of Administrative Hearings this 6th day of March, 1984.

COPIES FURNISHED:

James H. Gillis, Esquire Department of Professional

Regulation

130 North Monroe Street Tallahassee, Florida 32391

Gerald Nelson, Esquire

4950 West Kennedy Boulevard Suite 693

Tampa, Florida 33609

Mr. Fred Roche Secretary

Department of Professional Regulation

130 North Monroe Street Tallahassee. Florida 32301

Ms. Dorothy Faircloth Executive Director

Board of Osteopathic Medical Examiners

Department of Professional Regulation

130 North Monroe Street Tallahassee, Florida 32301

Docket for Case No: 83-002749

Orders for Case No: 83-002749