STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD ) OF MEDICINE, )

)

Petitioner, )

)

vs. ) Case No. 03-0421PL

)

PAUL M. MURRY, M.D., )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, a formal hearing was held in the above styled cause before the Division of Administrative Hearings by its duly designated Administrative Law Judge, Florence Snyder Rivas, on April 21 and 22, 2003, in Fort Lauderdale, Florida.

APPEARANCES

For Petitioner: Irving Levine, Esquire

Department of Health 4052 Bald Cypress Way Bin C-65

Tallahassee, Florida 32399-3265

For Respondent: Jon M. Pellett, Esquire

Barr, Murman, Tonelli, Slother and Sleet, P.A.

201 East Kennedy Boulevard Suite 1700

Tampa, Florida 33602

STATEMENT OF THE ISSUE

At issue is whether the Respondent committed the offenses set forth in the Corrected Administrative Complaint and, if so, what penalty should be imposed.

PRELIMINARY STATEMENT

By Corrected Administrative Complaint dated February 5, 2003, Petitioner, Department of Health, (Petitioner or Department of Health) charged that Respondent, Paul M. Murry, M.D., (Respondent or Murry), violated Sections 458.331(1)(t), 458.331(1)(m), and 458.331(1)(q), Florida Statutes, in that he:

1. fell below the appropriate standard of care by failing to ascertain whether Patient C.R. (C.R.) was pregnant prior to ordering an MMR (measles, mumps and rubella) vaccination;

2. failed to keep written medical records justifying the course of treatment by failing to take a proper medical history and failed to record whether C.R. was pregnant before prescribing the MMR vaccination; and/or (c) prescribed, dispensed, administered, mixed, or otherwise prepared a legend drug by inappropriately prescribing an MMR vaccine to C.R. who was, in fact, pregnant.

Respondent timely exercised his right to an administrative hearing.

At the hearing, Petitioner presented the testimony of C.R. and medical expert, David A. Libert, M.D., and offered into

evidence Exhibits 1 through 5. Exhibits 1, 2, 3, and 5 were admitted.

Respondent testified in his own behalf and presented the testimony of Josette Lewis-Harris, his medical technician; medical expert Harry Curtis Benson, M.D.; and his partner Ben Reiter, M.D. Respondent also offered Exhibits 1 through 9, which were admitted into evidence.

A transcript of the proceedings was filed on May 5, 2003.

The parties requested and were granted 15 business days from the filing of the transcript to submit Proposed Recommended Orders, which have been carefully considered in the preparation of this Recommended Order.

FINDINGS OF FACT

1. Petitioner is the state agency responsible for regulating the practice of medicine in Florida.

2. Respondent is, at all times material to this case, a licensed physician in the state of Florida and employed by Bennett Family Practice in Boca Raton, Florida. He has no prior disciplinary history, and had been uneventfully licensed to practice medicine in Florida since 1994.

3. C.R. became a patient of Bennett Family Practice on April 21, 2000. She saw medical professionals other than Respondent for a couple of minor matters prior to the office visit which gives rise to this case.

4. On July 9, 2001, C.R. went to Bennett Family Practice in order to seek an MMR vaccination in furtherance of her application to do graduate work at Florida Atlantic University (FAU). FAU required that prospective students obtain this vaccination, as part of the application process, or obtain documentation of a medical excuse to forego the vaccination.

5. The portion of the application package dealing with medical issues, including vaccinations, contains a warning that pregnant women, or women who are attempting to conceive, should not be vaccinated.

6. On July 9, 2001, C.R. was over 34 years old, and newly pregnant.

7. Pregnancy is one of several contraindications to the administration of an MMR vaccine. Other contraindications include certain allergies, and HIV positive status.

8. Murry made no effort to determine what, if any, of these contraindications might be present. No factual circumstances existed at the time which would have justified the administration of the vaccine to C.R. while she was pregnant.

9. C.R. brought to her appointment an FAU immunization form. The form contained four pages with six parts and directed the student or parent to fill in the first three parts on the first two pages and the health care provider to fill in the remainder. C.R. filled in the parts for the student or parent;

   however, she had not read nor filled out any other portion of the four page form.

10. Murry testified to his expectation that a well educated patient, which C.R. undisputedly is, “should” have read the form she came in with. However, Murry did not communicate that expectation to C.R.

11. It is the responsibility of the physician to take reasonable measures to ascertain the existence of contraindications to administering a vaccination, including the pregnancy status of a woman of childbearing age who seeks an MMR vaccination, yet Murry failed to take any measure directed at obtaining this basic information.

12. More specifically, the Center for Disease Control (CDC) advises that “. . . women of childbearing age should receive rubella-containing vaccines . . . only if they state that they are not pregnant and only if they are counseled not to become pregnant for 3 months after vaccination.” C.R. made no such statement and did not receive the counseling recommended by the CDC.

13. In some practices, including Murry’s, office protocol requires that patients be provided with an information form concerning the risks, benefits, and contraindications for the vaccination. Where this procedure is employed, it remains the

    physician’s responsibility to take the steps necessary to assure that the patient has in fact read the form, and understands it.

14. Once the doctor affirmatively determines that a female patient of childbearing age is not pregnant, and has been appropriately counseled not to become pregnant for three months, the standard of care further requires that this information be documented in her medical record.

15. Because neither Murry nor an appropriately trained staff member discussed with C.R. the issue of pregnancy as it relates to a woman of childbearing age seeking the MMR vaccination, it follows that her patient chart does not reflect any information on the date she received the vaccine relating to her pregnancy status.

16. Murry's office protocol does not call for either the doctor or the medical technician who prepares and gives the vaccination to document that the patient read the information sheet and understood it. Thus, there is no way to be sure that, on a busy day, the protocol was followed. In this case, the greater weight of evidence suggests that it was not.

17. The vaccination was given to C.R. by certified medical assistant Josette Lewis-Harris (Lewis-Harris). On an average day, Lewis-Harris sees as many as 40 patients.

18. Lewis-Harris claims to have given C.R. an MMR information form. C.R. denies that. In weighing the

    conflicting evidence on this point, the undersigned had the opportunity to closely observe the demeanor of C.R. and Lewis- Harris and to consider their demeanor while testifying in light of their opportunity and motivation to fully and completely recall the details of C.R.'s July 9 visit.

19. Also taken into account is the testimony of Murry and one of his partners, whose testimony concerning office protocols for vaccinations left room for doubt that medical technicians at Bennett Family Practice are appropriately trained to be the safety net to ensure that vaccinations are not administered where contraindicated.

20. Lewis-Harris does not recall many details about her brief encounter with C.R., while C.R. states unequivocally that no Bennett employee provided her with a form to read.

21. The form which Murry contends was provided to C.R. in accordance with office protocol does state that pregnant women should not have the vaccination; however, the form is dominated by sketches of a little boy and a baby, and is, by its own title, directed to parents of young children. The form is titled M M AND R Vaccine (MMR) and subtitled, "What you need to know before you or your child gets the vaccine." Nothing about the form would attract the attention of a woman who thought herself to be pregnant, or who was attempting to become pregnant.

22. Because C.R. was one of as many of 40 patients encountered that day by Lewis-Harris, the tribunal credits the memory of C.R. as being more accurate on the matter of whether Lewis-Harris provided C.R. with the form.

23. However, even if C.R. had been furnished the form, it would not absolve Murry of liability for violating the standard of care, where, as here, Lewis-Harris admits that she never asked C.R. if she might be pregnant. C.R. was not counseled not to become pregnant, and no contemporaneous documentation exists to establish that C.R. was given the form which explains the dangers of the MMR vaccine, and that she was cognizant of the section of the form which discussed pregnancy.

24. More fundamentally, the evidence failed to establish that the responsibility for averting a possibly life threatening consequence can be shifted onto a patient in the manner suggested by Respondent, no matter how well educated the patient might be.

25. Lewis-Harris testified somewhat ambiguously about C.R. having expressed reluctance to get the shot. Yet, Lewis-Harris did not alert Murry to that reluctance. If in fact Lewis- Harris’ memory on this point is accurate, it further underscores the inadequacy of Murry’s supervision of the potentially dangerous process of administering vaccinations. A patient who

    expresses reluctance to receive a vaccine warrants scrutiny and evaluation which is beyond the training of a medical technician.

26. In failing to make any effort to ascertain C.R.’s pregnancy status, and to counsel her that, as a woman of childbearing age, she should take care not to become pregnant for three months following administration of the MMR vaccine, Respondent failed 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.

27. In reaching the factual determination that Murry violated the standard of care under the unique facts of this case, careful consideration was given to the testimony of the expert witnesses for both sides.

28. Dr. Libert, Petitioner's expert witness, testified that Murry's conduct did not meet the required standard of care. His testimony was credible.

29. The testimony of Respondent's expert was discredited by his imprecise grasp of the facts of this case and his unwillingness to render unqualified testimony. For example, Respondent’s expert, under direct examination by Murry’s attorney, was asked if he was “familiar with what the standard of care requires for the administration of MMR vaccine.” He attempted an answer, but qualified it by saying "again this is

    out of my field of course.” This qualification did nothing to bolster confidence in his opinion that ordering the MMR vaccination for CR was within the standard of care.

30. Murry's expert further discredited himself when he stated that “since the patient had received printed literature for her and her husband to review, that there was no breach of the standard of care.” There is no record evidence that C.R.’s husband was present on July 9, 2001, and, in any event, the evidence established that C.R. is a competent adult, thus, the duty of care was owed to her, and not her husband.

31. On balance, the testimony of Petitioner’s expert is the more credible and persuasive and is given greater weight. That testimony, and the record as a whole, amply supports the conclusion that it is not within the standard of care to rely exclusively upon a form document when the answer to one direct question might avoid possible catastrophic consequences.

32. Additionally, the evidence established that an MMR vaccine is a legend drug, which was inappropriately prescribed under the facts and circumstances of this case.

33. After she received the vaccination, C.R. learned of the contraindication and telephoned Murry’s office. Murry arranged for her to be seen by an obstetrician, but C.R. chose not to continue care with Murry and his partners.

34. Murry argues that C.R.’s fetus likely did not suffer any actual injury by reason of the vaccination. Be that as it may, the standard of care was violated when the vaccination was given. What happened after is irrelevant. Neither can any inference in Murry's favor be drawn from C.R.'s refusal to follow his suggestion as to whom to consult for follow-up care.

    CONCLUSIONS OF LAW

    
    

35. The Division of Administrative Hearings has jurisdiction over the parties to and subject matter of this proceeding, pursuant to Sections 120.569, and 120.57, Florida Statutes, and Section 456.073, Florida Statutes.

36. In this case, Petitioner bears the burden of proof by clear and convincing evidence. Department of Banking and Finance, Division of Securities and Investor Protection v.

    Osborne Stern Company, 670 So. 2d 932 (Fla. 1996); Ferris v. Turlington, 510 So. 2d 292 (Fla. 1st DCA 1987); and Florida Department of Transportation v. J.W.C. Company, Inc., 396 So. 2d 778 (Fla. 1st DCA 1981).

37. Sections 458.331(1)(m), (q), and (t), Florida Statutes, provide in pertinent part:

    Grounds for disciplinary action; action by the board and department.-

    1. The following acts shall constitute grounds for which the disciplinary actions specified in subsection (2) may be taken:

       
       

       * * *

       
       

       (m) Failing to keep legible, as defined by department rule in consultation with the board, medical records that identify the licensed physician or the physician extender and supervising physician by name and professional title who is or are responsible for rendering, ordering, supervising, or billing for each diagnostic or treatment procedure and that justify the course of treatment of the patient, including, but not limited to, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; and reports of consultations and hospitalizations.

       
       

       * * *

       
       

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

       s.766.102 when enforcing this

       paragraph. . . . As used in this paragraph,

       . . . “the failure to practice medicine with

       that level of care, skill, and treatment which is recognized by a reasonable prudent similar physician as being acceptable under similar conditions and circumstances,” shall not be construed so as to require more than one instance, event, or act. Nothing in this paragraph shall be construed to require that a physician be incompetent to practice medicine in order to be disciplined pursuant to this paragraph.

       
       

38. Rule 64B8-9.003, Florida Administrative Code, promulgated by the Board of Medicine, states in pertinent part:

    64B8-9.003 Standards for Adequacy of Medical Records.

    
    

    1. Medical records are maintained for the following purposes:

       1. To serve as a basis for planning patient care and for continuity in the evaluation of the patient’s condition and treatment.

       2. To furnish documentary evidence of the course of the patient’s medical evaluation, treatment, and change in condition.

       3. To document communication between the practitioner responsible for the patient and any other health care professional who contributes to the patient care. To assist in protecting the legal interest of the patient, the hospital, and the practitioner responsible for the patient.

       4. To assist in protecting the legal interest of the patient, the hospital, and the practitioner responsible for the patient.

    2. A licensed physician shall maintain patient medical records in a legible manner and with sufficient detail to clearly demonstrate why the course of treatment was undertaken or why an apparently indicated course of treatment was not undertaken.

    3. The medical record shall contain sufficient information to identify the

       patient, support the diagnosis, justify the treatment and document the course and results of treatment accurately, by including, at a minimum, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; reports of consultations and hospitalizations; and copies of records or reports or other documentation obtained from other health care practitioners at the request of the physician and relied upon by the physician in determining the appropriate treatment of the patient.

    4. All entries made into the medical records shall be accurately dated and timed. Late entries are permitted, but must be clearly and accurately noted as late entries and dated and timed accurately when they are entered into the record. However, office records do not need to be timed, just dated.

       
       

39. Chapter 465, Florida Statutes, relating to Pharmacy, Sections 465.003(7) and (8), Florida Statutes, provide in pertinent part:

    1. Definitions.-As used in this chapter the term:

       
       

       * * *

       
       

       1. “Institutional formulary system" means a method whereby the medical staff evaluates, appraises, and selects those medicinal drugs or proprietary preparations which in the medical staff's clinical judgment are most useful in patient care, and which are available for dispensing by a practicing pharmacist in a Class II institutional pharmacy.

       2. “Medicinal drugs" or “drugs" means those substances or preparations commonly known as “prescription" or “legend" drugs which are required by federal or state law to be dispensed only on a prescription, but

    shall not include patents or proprietary preparations as hereafter defined.

    
    

40. The Petitioner has proven, by clear and convincing evidence, that Murry failed 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, in that he prescribed an MMR vaccine for C.R. without making any effort to determine her pregnancy status, or to counsel her, as a female of childbearing age, that pregnancy was contraindicated for three months following administration of the vaccine.

41. Additionally, Petitioner has established by clear and convincing evidence that C.R.'s medical file was not adequately maintained because Respondent failed to document any inquiry about the pregnancy status of C.R.

42. Finally, Petitioner has established by clear and convincing evidence that an MMR vaccine, a prescription or legend drug as defined in Sections 465.003 (7) and (8), Florida Statutes, was inappropriately ordered because the medical record and underlying factual circumstances did not justify the prescribing of an MMR vaccine to a female of childbearing age when no inquiry had been made concerning pregnancy or other contraindications for receiving the vaccine.

43. Upon a finding of guilt of any of the grounds set forth in Section 458.331(1), Florida Statutes, the Board of Medicine may enter an order imposing one or more of the following penalties:

    1. Refusal to certify, or certification with restrictions, to the department an application for licensure, certification, or registration.

    2. Revocation or suspension of a license.

    3. Restriction of practice.

    4. Imposition of an administrative fine not to exceed $10,000 for each count or separate offense.

    5. Issuance of a reprimand.

    6. Placement of the physician on probation for such 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.

    7. Issuance of a letter of concern.

    8. Corrective action.

    9. Refund of fees billed to and collected from the patient.

    
    

44. The disciplinary guidelines of the Board of Medicine, found at Rule 64B8-8.001, Florida Administrative Code (FAC), provide a range of penalties for violations of the provisions of Section 458.331, Florida Statutes. A violation of Section 458.331(1)(m), Section 458.331(1)(q), and Section 458.331(1)(t) each has a range of years of probation to revocation, and

    administrative fines for each count of from $1,000.00 to

    
    

    $10,000.00.

    
    

45. Rule 64B8-8.001(3), Florida Administrative Code, also authorizes the Board of Medicine to deviate from the penalties recommended in the disciplinary guidelines based upon consideration of aggravating and mitigating factors. The Rule further requires the Board to consider certain aggravating factors, including the following:

(a) Exposure of patient or public to injury or potential injury, physical or otherwise: none, slight, severe, or death;

* * *

(h) Any other relevant mitigating factors.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of Law and upon consideration of the Recommended Range of Penalty under Rule 64B8-8.001(2), Florida Administrative Code, and Aggravating and Mitigating Circumstances under Rule 64B8- 8.001(3), Florida Administrative Code, it is RECOMMENDED that the Board enter a final order finding Respondent guilty of the charges outlined in the Administrative Complaint and imposing the following penalties:

1. A reprimand;

2. An administrative fine of $20,000 (consisting of $10,000 for the standard of care (t) violation and $5,000 each for the medical records (m) and legend drug (q) violations);

3. Continuing medical education classes specified by the Board;

4. Corrective action with respect to office protocols for determining if vaccinations are appropriate to the particular patient;

5. A refund of all fees paid by C.R. and/or her insurer for services rendered on July 9, 2001.

6. One year of probation, with terms set by the Board.

It is further RECOMMENDED that the Board should also impose costs associated with the investigation and prosecution of this case in compliance with Section 456.072(4), Florida Statutes.

DONE AND ENTERED this 10th day of June, 2003, in Tallahassee, Leon County, Florida.

FLORENCE SNYDER RIVAS

Administrative Law Judge

Division of Administrative Hearings The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-3060

(850) 488-9675 SUNCOM 278-9675

Fax Filing (850) 921-6847 www.doah.state.fl.us

Filed with the Clerk of the Division of Administrative Hearings this 10th day of June, 2003.

COPIES FURNISHED:

Irving Levine, Esquire Department of Health 4052 Bald Cypress Way Bin C-65

Tallahassee, Florida 32399-3265

Jon M. Pellett, Esquire

Barr, Murman, Tonelli, Slother and Sleet, P.A.

201 East Kennedy Boulevard Suite 1700

Tampa, Florida 33602

Larry McPherson, Executive Director Board of Medicine

Department of Health 4052 Bald Cypress Way

Tallahassee, Florida 32399-1701

R. S. Power, Agency Clerk Department of Health

4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701

William W. Large, General Counsel Department of Health

4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701

Dr. John O. Agwunobi, Secretary Department of Health

4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701

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: 03-000421PL

Orders for Case No: 03-000421PL