STATE OF FLORIDA DIVISION OF ADMINISTRATIVE HEARINGS

AGENCY FOR HEALTH CARE )

ADMINISTRATION, )

)

Petitioner, )

)

vs. ) CASE NO. 94-6352

)

PHILIP F. WATERMAN, II, )

)

Respondent. )

)

RECOMMENDED ORDER

Robert E. Meale, Hearing Officer of the Division of Administrative Hearings, conducted the final hearing in Ft. Myers, Florida, on April 25, 1996.

APPEARANCES

For Petitioner: Steven Rothenburg, Senior Attorney

Agency for Health Care Administration 9325 Bay Plaza Boulevard, Suite 210

Tampa, Florida 33619

For Respondent: Bruce D. Lamb

Shear Newman

201 East Kennedy Boulevard, Suite 1000 Tampa, Florida 33602

STATEMENT OF THE ISSUES

The issues are whether Respondent is guilty of violations of Section 458.331(1)(k), (m), and (t) in the practice of medicine and, if so, what penalty the Board of Medicine should impose.

PRELIMINARY STATEMENT

The Administrative Complaint dated May 31, 1995, alleges that Respondent is guilty of making deceptive, untrue, or fraudulent representations in the practice of medicine by altering a patient's records, in violation of Section 458.331(1)(k); failing to keep written medical records justifying the course of treatment of a patient by not adequately outlining the examination of Patient D. W., in violation of Section 458.331(1)(m); and committing gross or repeated malpractice or failing to practice medicine with that level of care, skill, and treatment that is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances by failing to keep adequate medical records on Patient D. W., altering Patient D. W.'s medical records, and failing to recommend follow-up examinations and treatments for Patient D. W.'s complaint of a lump in her breast, in violation of section 458.331(1)(t).

By Election of Rights dated June 14, 1995, Respondent requested the opportunity to discuss a settlement. By Petition for Formal Hearing dated July 11, 199[5], Petitioner disputed the material allegations and demanded a formal hearing.

At the hearing, Petitioner called two witnesses and offered into evidence four exhibits. Respondent called ten witnesses and offered into evidence nine exhibits. The parties jointly sponsored two exhibits. All exhibits were admitted.

The court reporter filed the transcript May 20, 1996. Rulings on timely filed proposed findings of fact are in the appendix.

FINDINGS OF FACT

1. Respondent is a licensed physician, holding license number ME 0033129. His license was originally issued on August 2, 1978, and remains current. There is no prior discipline against Respondent.

   
   

2. Respondent has been certified for over 15 years by the American Board of Obstetrics and Gynecology. His practice has been devoted to obstetrics and gynecology.

   
   

3. In 1990, Respondent was a member of a large group practicing obstetrics and gynecology in Cape Coral. Respondent was performing about 100 breast examinations a week.

   
   

4. On the evening of April 10, 1990, D.W., who was 30 years old at the time, discovered a mass that felt like a marble in her right breast during a breast self-examination. She was upset and cried most of the night, fearful that she had breast cancer. Early the next morning, she made an appointment with Respondent's group for a breast examination later that day.

   
   

5. A regular patient of another member of Respondent's group, who was unavailable on April 11, D. W. had last been seen by a member of Respondent's group on February 6, 1990, when her regular physician gave her an annual examination. Her breast examination at the time was normal. During the visit, the physician or nurse reviewed breast self-examination techniques with her. The physician started D. W. on birth control pills and directed her to return for a follow-up visit in two months.

   
   

6. The April 11 office visit was devoted exclusively to addressing D. W.'s complaint of a lump in her breast. Respondent examined D. W.'s breasts with D.

   W. lying down and then sitting up. He felt nothing. While sitting up, D.W. guided Respondent's hand to the mass in the right breast. Still feeling nothing, Respondent remarked that the breast was somewhat fibrous.

   
   

7. Respondent explained to D. W. that fibrocystic disease is something that women sometimes get in their breasts and it is nothing to worry about. In fact, at least 80 percent of all women in their 30s undergo fibrocystic changes in the breast.

   
   

8. Respondent did not reach a specific diagnosis as a result of the April

   11 office visit. The handwritten entries in Respondent's medical records--the complaint and blood pressure appearing to have been written by a nurse--read in their entirety:

   4-11-90 Pt. c/o lump in R breast.

   BP--100/60

   no mass found somewhat fibrous

   [Respondent's initials]

   
   

9. Respondent did not advise D. W. to return to the office for a follow-up visit at a prescribed interval or if she detected the same mass or any changes in the mass.

   
   

10. D. W. next visited Respondent's group on April 11, 1991, for her annual visit. She was seen by another physician in the group. D. W. told the physician of the lump in her breast and said that it was getting larger. The physician conducted a breast examination and felt a mass about two centimeters in diameter.

    
    

11. Concerned about the mass, the physician scheduled an aspiration for diagnostic purposes. The results of the procedure disclosed severely atypical cells that were suspicious for carcinoma.

    
    

12. The physician referred her to a surgeon, who first saw D.W. on May 2, 1991. The surgeon performed a breast biopsy on May 9. The biopsy revealed an infiltrating ductal carcinoma of the breast. Based on the biopsy findings, the surgeon conducted on May 17 a right modified radical mastectomy. The excised tumor measured 2.1 centimeters along its longest diameter. D. W. underwent chemotherapy and has had no recurrence of the cancer in the five years since the surgery.

    
    

13. There are two sets of allegations concerning D.W.'s medical records. The first set of allegations is that Respondent fraudulently altered D. W.'s medical records.

    
    

14. Someone in Respondent's office later typed the following addition to the records of D. W. immediately beneath the handwritten entry quoted above:

    
    

    D[.] came to the office today having felt a lump in her right breast. I could not feel anything, although her breast was somewhat fibrous. I told her to continue to check

    her breast and come back if she felt it again.

    
    

    [Respondent's initials/typist's initials--

    {both typed}]

    
    

15. Petitioner failed to prove that Respondent dictated or typed the note in the preceding paragraph or that he authorized the addition of this note to D.W.'s medical records. The intent in adding the note was fraudulent as to the third sentence, which is the only sentence in the note that is untrue. But Petitioner failed to prove that Respondent was in any way involved in the fraud.

    
    

16. The second set of allegations concerning the medical records involves the adequacy of the records. Specifically, Petitioner alleges that Respondent failed to keep medical records justifying the course of treatment and violated the applicable standard of care by failing to keep adequate medical records. These allegations are best considered together with the remaining allegation,

    which is that Respondent violated the applicable standard of care by failing to recommend follow-up examinations and treatments for D. W.'s complaint of a lump in her breast.

    
    

17. A violation of the applicable standard of care is 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 standard of care in this case pertains to the practice in early 1990.

    
    

18. Petitioner nowhere alleges that Respondent violated the applicable standard of care by failing to detect the mass of which D.W. complained. Petitioner's expert witness, Dr. Harvey Gardy, conceded that such a failure would not necessarily violate the standard of care. Nor is it clear that the mass of which D.W. complained in April 1990 developed into the tumor removed from her breast a year later.

    
    

19. The mass of which D. W. complained in April 1990 was in the three o'clock position, and the excised tumor was in the 12 o'clock position. Breast tumors do not change location, except to the extent that they grow, although patients conducting self- examinations may have difficulty locating the tumor with precision. Also, the excised tumor could have grown from an impalpable size in April 1990 to its size at the time of the mastectomy a year later.

    
    

20. The second set of medical records allegations and the lone remaining standard of care allegation focus not on Respondent's alleged failure to detect and diagnose the mass of which D. W. complained, but on Respondent's alleged failure to respond adequately to D. W.'s complaint, even after he could not independently verify the mass.

    
    

21. The applicable standard of care did not require Respondent to order further testing at the time to rule out a cancerous growth when he could not feel the mass. D. W. was not in a high-risk category for breast cancer based on her young age, three past pregnancies, and relevant family history. She displayed no physical signs of breast cancer.

    
    

22. The physician conducting a breast examination is looking for a dominant or distinct mass--an isolated lump distinct from surrounding breast tissue. Respondent felt only fibrous changes. The applicable standard of care did not require that a physician order further diagnostic testing each time the physician detected a fibrous mass in a breast. Fibrous changes are not indicative of breast cancer. Petitioner has failed to prove that the applicable standard of care was any different when the patient claimed to have felt a distinct mass that the physician is unable to verify.

    
    

23. It is more practical to direct a patient to return for a follow-up examination than to order potentially expensive tests. However, Petitioner failed to prove that the applicable standard of care required that a physician, failing to detect a mass in a patient not in a high-risk category for breast cancer, direct her to return to the office at a specified interval, such as two or three months later.

    
    

24. Even less onerous than diagnostic testing or return office visits is the physician's direction that the patient return to the office if she feels the mass again or any changes in the mass. However, Petitioner failed to prove that the applicable standard of care required even this sensible precautionary direction from a physician.

25. Testifying unpersuasively that the standard of care required the setting of a follow-up appointment, Dr. Gardy failed to testify at all whether the standard of care required Respondent to tell D. W. to return if she detected the mass again in a self-examination.

    
    

26. One of Respondent's expert witnesses, Dr. Pierre Bouis, testified clearly on direct that the applicable standard of care did not require Respondent to direct D. W. to return if she felt the mass again (Tr. p. 125). On cross-examination, Dr. Bouis returned to the same issue and answered affirmatively the following, poorly worded question:

    
    

    Now, isn't it true that you also believe that it's an appropriate standard of care to tell a patient who presents under the same set of fact that she should keep checking herself and return if she feels it again or continue to feel it?

    
    

27. Although there are many levels of care, there is a single applicable standard of care, which, if violated, justifies the imposition of discipline. By using "an," Petitioner's counsel suggested multiple standards of care and left open the possibility that the standard to which Dr. Bouis referred in his answer was aspirational, rather than mandatory.

    
    

28. Respondent's other expert witness, Dr. J. Kell Williams, testified clearly that Respondent's failure to direct D. W. to return if she felt the lump again did not violate the applicable standard of care (Tr. pp. 43 and 52). Dr. Williams conceded that the better practice would have been to direct the patient to return (TR. pp. 43, 46, and 47), but he did not equate this practice with the applicable standard of care.

    
    

29. In the absence of evidence establishing this sensible precaution as the applicable standard of care, Petitioner has failed to prove by clear and convincing evidence that the applicable standard of care required Respondent to advise D. W. that she should return to the office if she felt the mass again or any changes in the mass.

    
    

30. The medical records are adequate for the limited purpose of the April

    11 visit. They describe the findings and adequately outline Respondent's examination of D. W. They justify the course of treatment--which was effectively no treatment--for the reasons set forth in the preceding paragraphs.

    
    

31. For the reasons set forth above, Petitioner has failed to prove by clear and convincing evidence the material allegations of the Administrative Complaint.

    
    

    CONCLUSIONS OF LAW

    
    

32. The Division of Administrative Hearings has jurisdiction over the subject matter. Section 120.57(1), Florida Statutes. (All references to Sections are to Florida Statutes.)

    
    

33. Section 458.331(2) authorizes the Board of Medicine to enter a final order imposing discipline for any violation of Section 458.331(1).

34. Section 458.331(1) provides in relevant part that the Board may impose discipline for:

    
    

    * * *

    (k) Making deceptive, untrue, or fraudulent representations in or related to the practice of medicine or employing a trick or scheme in the practice of medicine.

    * * *

    (m) Failing to keep medical records justifying 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.

    * * *

    (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. . . .

    
    

35. Petitioner must prove the material allegations by clear and convincing evidence. Ferris v. Turlington, 510 So. 2d 292 (Fla. 1987).

    
    

36. There is no evidence of gross or repeated malpractice. For the reasons set forth above, Petitioner failed to prove by clear and convincing evidence that Respondent fraudulently altered D. W.'s medical records or was in any way involved in such fraud, failed to keep medical records justifying the course of

D. W.'s treatment by inadequately outlining the patient examination, or violated the applicable standard of care with respect to the adequacy or alteration of the medical records or the failure to recommend follow-up examinations or treatments for D. W.

RECOMMENDATION

It is

RECOMMENDED that the Board of Medicine enter a final order dismissing the Administrative Complaint against Respondent.

ENTERED on May 31, 1996, in Tallahassee, Florida.

ROBERT E. MEALE, Hearing Officer Division of Administrative Hearings The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-1550

(904) 488-9675

Filed with the Clerk of the Division of Administrative Hearings on May 31, 1996.

APPENDIX

Rulings on Petitioner's Proposed Findings

1-3: adopted or adopted in substance, except she told him about the lump.

Respondent never saw a lump.

4: adopted or adopted in substance, except that Respondent did not feel the marble-like mass that D. W. felt. Respondent felt only fibrocystic changes in the breast.

5-9 (second sentence): adopted or adopted in substance.

9 (remainder): rejected as irrelevant and recitation of testimony. 10-11 (second sentence): adopted or adopted in substance.

11 (remainder): rejected as irrelevant and recitation of testimony. 12-13 (first sentence): adopted or adopted in substance.

13 (remainder)-15: rejected as subordinate.

16 (first sentence): adopted or adopted in substance.

16 (second sentence)-17: rejected as recitation of evidence.

18: adopted or adopted in substance, as distinguished from the 2 cm tumor within the larger excised mass.

19: rejected as subordinate.

20: rejected as unsupported by the appropriate weight of the evidence. 21: rejected as irrelevant with respect to applicable standard of care. 22: rejected as unsupported by the appropriate weight of the evidence.

The questions posed Dr. Bouis were ambiguous as to whether he was describing the better practice or the applicable standard of care.

23-24: rejected as irrelevant with respect to applicable standard of care. 25: rejected as subordinate and irrelevant.

26: rejected as subordinate.

27: rejected as unsupported by the appropriate weight of the evidence. 28: rejected as subordinate.

29-32: adopted or adopted in substance. 33: rejected as subordinate.

34: rejected as unsupported by the appropriate weight of the evidence. 35: rejected as subordinate.

36-38: rejected as subordinate and recitation of testimony.

39: rejected as unsupported by the appropriate weight of the evidence. 40: rejected as recitation of testimony.

41-43: rejected as unsupported by the appropriate weight of the evidence. 44-45: rejected as irrelevant.

46: adopted or adopted in substance.

COPIES FURNISHED:

Dr. Marm Harris, Executive Director Board of Medicine

1940 North Monroe Street Tallahassee, Florida 32399-0792

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

Tallahassee, Florida 32308-54034

Steven Rothenburg, Senior Attorney Agency for Health Care Administration 9325 Bay Plaza Boulevard, Suite 210

Tampa, Florida 33619

Bruce D. Lamb Shear Newman

201 East Kennedy Boulevard, Suite 1000 Tampa, Florida 33602

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions to this Recommended Order. All agencies allow each party at least 10 days in which to submit written exceptions. Some agencies allow a longer period within which to submit written exceptions. You should contact the agency that will issue the final order concerning agency rules on the deadline for filing exceptions to this Recommended Order. Any exceptions to this Recommended Order should be filed with the agency that will issue the final order.

Docket for Case No: 94-006352

Orders for Case No: 94-006352