STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

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

)

Petitioner, )

)

vs. ) CASE NO. 94-3214

)

RICHARD L. PLAGENHOEF, M.D., )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to Notice, this cause was heard by Linda M. Rigot, the assigned Hearing Officer of the Division of Administrative Hearings, on October 2, 1995, in Tallahassee, Florida.

APPEARANCES

For Petitioner: Joseph P. Garwood, Esquire

Agency for Health Care Administration Board of Medicine

1940 North Monroe Street Tallahassee, Florida 32399-0792

For Respondent: Did not appear and was not represented.

STATEMENT OF THE ISSUE

The issue presented is whether Respondent is guilty of the allegations contained in the Administrative Complaint filed against him, and, if so, what disciplinary action should be taken against him, if any.

PRELIMINARY STATEMENT

On November 17, 1992, Petitioner filed an Administrative Complaint against Respondent alleging that he had violated several of the statutes regulating his conduct as a physician, and Respondent timely requested a formal hearing regarding the allegations contained in that Administrative Complaint. On June 8, 1994, this cause was transferred to the Division of Administrative Hearings to conduct the formal proceeding.

Petitioner presented the testimony of Bonnie M. Phipps; Tillinghast G. Lybass, M. D.; and Lee A. Fischer, M. D. Further, Petitioner's Exhibits numbered 1-3, 5-8, 10, and 11 were admitted in evidence.

Only Petitioner submitted post-hearing proposed findings of fact in the form of a proposed recommended order. A specific ruling on each proposed finding of fact can be found in the Appendix to this Recommended Order.

FINDINGS OF FACT

1. At all times material hereto, Respondent has been a physician licensed in the State of Florida, having been issued license number ME 0055126.

   
   

2. On December 4, 1989, D.W. presented herself as a patient at Unity Health Center, where Respondent was employed as a physician. She complained of headaches, insomnia, and jerking of her muscles. She advised that she had had her roof repaired and other repairs done to her home and feared she was reacting to some of the chemicals involved with those repairs. She further advised that the health department had evaluated her home for the presence of formaldehyde, carbon monoxide, and other toxins but none had been detected.

   
   

3. Respondent took a minimal, at best, history but performed no physical examination. Yet, Respondent diagnosed the patient as suffering from chemical toxicity. He recommended a holistic diet and prescribed a number of homeopathic or holistic substances. He recommended that the patient return in three weeks to be re-checked.

   
   

4. The patient returned to Unity Health Center on December 28, 1989. Respondent recommended an Interro test to check her chemical toxicity levels. The patient submitted to that test, and Respondent used the results of the Interro testing to confirm his diagnosis of chemical toxicity related to chemicals in the patient's environment from the repair of her roof.

   
   

5. The Interro machine indicated that the patient had elevated levels of formaldehyde; toxic levels of arsenic, lead, and mercury; and a sensitivity to mold and yeast. Respondent prescribed additional homeopathic or holistic substances including "de-tox drops", prescribed a tranquillizer, and recommended that the patient return in three weeks to be re-checked.

   
   

6. Respondent used the Interro machine as a diagnostic instrument. His medical records contain no notation that the patient gave informed consent for the use of the Interro machine for that purpose, and no written informed consent is contained in Respondent's records.

   
   

7. The Interro machine is a device with certain dials and switches on it and an electrode 3-4 inches long and approximately 1/2 inch in diameter, cylinder-shaped, which is held in the patient's hand. The other cord attached to the machine has two electrodes that go around the patient's index and ring fingers of the left hand, much like a polygraph machine. The third component is a wand which is held by the tester. When the patient is hooked up to the Interro machine with the two electrodes on the left hand and holding the other electrode in the right hand, the wand is pressed into certain "acu-pressure points" by the tester. A needle on the machine indicates the patient's sensitivity to whatever substance the tester has the machine "tuned to".

   
   

8. The Interro machine is a device purported by its manufacturer to be a computerized question and answer device which measures changes in the patient's skin conductivity in response to computer-generated questions. The Interro's training manual specifically represents that it is not a medical device; rather, it is a communication device. The Interro machine is not approved by the federal Food and Drug Administration as a medical diagnostic device.

   
   

9. Rather than returning to Respondent or Unity Health Center, the patient went to Dr. Tillinghast Lybass, a specialist in allergies and immunology, for a second opinion on January 9, 1990. She complained of allergies and chemical

   toxicity and advised Lybass of Respondent's diagnosis. She advised Lybass of the inspection of her home by the health department and of the repairs done on her roof. She discussed her previous exterminating service.

   
   

10. D.W.'s complaints to Lybass were headaches, itching, body jerking, blurred vision, redness of her eyes, and insomnia. Lybass took a complete history of her symptoms, the course of her illness, her past medical history, her family medical history, and her environmental history. He did an allergy work-up on D. W. and tested her for sensitivity to mold and mildew, to a natural pesticide found in a plant, to formaldehyde, and to some of the materials that were listed in the safety information sheets the patient obtained from the contractor that had done the repair work in her home. He obtained a copy of Respondent's medical records on the patient.

    
    

11. Dr. Lybass was unable to document any significant degree of allergy antibodies in the patient's blood. Although he performed specific skin tests for the major molds, the patient did not demonstrate any sensitivity. Further, the patient's blood chemistries were normal except for an elevated cholesterol level. Lybass did not do any specific tests for heavy metals since there was no reason to indicate or expect that the patient had any kind of heavy metal poisoning from the patient's history. He had the patient expose a culture plate at her home and learned there was no significant amount of mold there.

    
    

12. Dr. Lybass diagnosed the patient's condition, based on her history and his physical examination and the tests he performed, as stress, anxiety, and fear or phobia of her environment.

    
    

13. Respondent was engaged in the practice of medicine when he diagnosed and treated patient D. W. His diagnosis was a medical diagnosis. He undertook to treat her complaints, recommending certain holistic or homeopathic remedies and even prescribing a tranquillizer which is a prescription drug.

    
    

14. Respondent failed to keep an adequate medical record of his examination and treatment of the patient. He took only a minimal history and documented no physical examination, not even vital signs. His medical record includes no plan for any recognized medical tests to support his diagnosis, and his records contain no justification for the use of the Interro machine on that patient. Although the patient presented with complaints that could have serious medical implications, Respondent did not perform or document any recognized medical tests to rule out any potential causes for the patient's symptoms.

    
    

15. The Interro device is not an accepted medical device in the medical community. The Interro device cannot be used to make a diagnosis of chemical toxicity since it does not test the patient's bloodstream. The Interro report contained in Respondent's medical record for patient D. W. does not purport to measure the chemicals in a patient's body; rather, it simply lists body systems in a graph.

    
    

16. Since the Interro device is not a diagnostic medical device, the use of that device to make a medical diagnosis, without first obtaining the full and informed consent of the patient, constitutes experimentation on a human subject.

    
    

17. Respondent made deceptive or untrue representations to patient D. W. Based on the results of the Interro testing, Respondent diagnosed the patient's symptoms as chemical sensitivity and mold sensitivity and recommended treatments and remedies. Respondent's representation of the Interro machine as a medical diagnostic device was untrue as was Respondent's representation that the patient

    was suffering from chemical and mold sensitivity. Those misrepresentations constituted a trick or scheme in the practice of medicine. D. W. was tricked into believing that Respondent had made an accurate diagnosis with the Interro device when the device in fact had no medical value.

    
    

18. Respondent practiced medicine below the acceptable standard of care of a reasonably prudent physician under similar conditions and circumstances in his diagnosis and treatment of patient D. W. On the basis of just a few questions and without a physical examination or the use of any medically recognized tests, Respondent made the diagnosis of chemical toxicity and prescribed various holistic medicine drops. He then used the Interro machine as a medical testing instrument and relied on the results of that testing in prescribing various holistic or homeopathic substances and diets.

    
    

    CONCLUSIONS OF LAW

    
    

19. The Division of Administrative Hearings has jurisdiction over the parties hereto and the subject matter hereof. Section 120.57(1), Florida Statutes.

    
    

20. The Administrative Complaint filed in this cause contains eight Counts with Counts One through Six relating to Respondent's treatment and diagnosis of

    D. W. (referred to as patient Number 1 in the Administrative Complaint) and Counts Seven and Eight relating to a different patient (referred to as patient Number 2). Prior to the final hearing in this cause, Petitioner moved to bifurcate the allegations as to patient Number 2, AHCA Case No. 89-06731, and that motion was granted. Accordingly, Petitioner presented no evidence as to that patient during the final hearing. On December 14, 1995, Petitioner filed a Status Report advising that all counts relating to patient Number 2 in this Administrative Complaint should be dismissed.

    
    

21. Count One charges Respondent with violating Section 458.331(1)(m), Florida Statutes, by failing to keep written medical records justifying the course of treatment of the patient, including examination results. Petitioner has proven its allegation that Respondent violated Subsection (m) since Respondent failed to document any physical examination of patient D. W. and failed to document in his medical records any justification for using the Interro machine, a non-diagnostic device, to make a medical diagnosis.

    
    

22. Count Two alleges that Respondent violated Section 458.331(1)(u), Florida Statutes, by performing any procedure or prescribing any therapy which, by prevailing medical community standards, would constitute experimentation on a human subject, without first obtaining the patient's full, informed, and written consent. Respondent violated Subsection (u) by using the Interro device on patient D. W. without first obtaining her informed, written consent to utilize the non-diagnostic Interro machine to make a medical diagnosis and prescribing remedies based on the Interro test results. Further, there is no documentation in Respondent's medical records reflecting that he advised the patient that his use of the Interro machine was experimental.

    
    

23. Respondent's medical records contain no written consent to the use of the Interro machine on patient D. W. and contain no notation that she gave verbal consent. Accordingly, Respondent violated Section 458.331(1)(p), Florida Statutes, as alleged in Count Three of the Administrative Complaint.

    
    

24. Count Four charges Respondent with violating Section 458.331(1)(n), Florida Statutes, by exercising influence on the patient so as to exploit the

    patient for financial gain. Petitioner alleges that Respondent charged D. W. for the Interro test although the test has no medical value. Petitioner presented no evidence that patient D. W. paid for her visit to Respondent, for the Interro test, or for the "de-tox" drops she was prescribed. Although it could be assumed that D. W. was charged for those services, Petitioner is required to prove its allegations, and Petitioner has failed to do so as to Count Four.

    
    

25. Section 458.331(1)(k), Florida Statutes, prohibits making deceptive, untrue, or fraudulent representations or employing a trick or scheme in the practice of medicine. Respondent violated that Subsection by failing to inform

    D. W. that the Interro test results had no medical value, as alleged in Count Five of the Administrative Complaint.

    
    

26. Count Six charges Respondent with violating Section 458.331(1)(t), Florida Statutes, by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician under similar conditions and circumstances. By failing to perform a physical examination, by basing his diagnosis of chemical toxicity on a device and test with no diagnostic value, and by treating patient D. W. with holistic herbs and diets, Respondent fell below the standard of care recognized by similar physicians.

    
    

27. Section 458.331(2), Florida Statutes, authorizes the Board of Medicine to take disciplinary action against a licensee who has violated Section 458.331(1), and Section 458.331(5) requires the Board to establish disciplinary guidelines. The Board has done so, and those guidelines are found in Rule 59R- 8.001, Florida Administrative Code. Aggravating and mitigating factors to be considered in establishing a penalty are also set forth in that Rule.

    
    

28. Patient D. W. had serious symptoms when she presented herself to Unity Health Center and to Respondent for diagnosis and treatment. Respondent's diagnosis of chemical toxicity based on no medical tests and on no physical examination, Respondent's use of the Interro machine to confirm that "diagnosis", and Respondent's treatment of D. W. with "de-tox drops" exposed the patient to potential harm since she was diverted from obtaining a medical diagnosis and medical treatment without knowing the cause of her symptoms. Although Respondent failed to attend the final hearing in this cause, he has directed correspondence to Petitioner and to the Division of Administrative Hearings which demonstrates his lack of remorse for his actions, his disdain of the "traditional" practice of medicine, his belief in the appropriateness of his actions, and his intent to continue to practice in a manner similar to his treatment of D. W.

    
    

29. Respondent's continued licensure constitutes a serious threat of harm to any patients. Respondent's license to practice medicine should be suspended until such time as he can demonstrate to the Board that he can practice medicine with skill and safety.

RECOMMENDATION

Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered:

1. Finding Respondent guilty of the allegations contained in Counts One, Two, Three, Five and Six of the Administrative Complaint filed in this cause;

2. Finding Respondent not guilty of the allegations contained in Count Four;

   
   

3. Dismissing Counts Seven and Eight of the Administrative Complaint filed in this cause; and

   
   

4. Suspending Respondent's license to practice medicine in the State of Florida until such time as Respondent can demonstrate to the Board of Medicine that Respondent can practice with skill and safety.

DONE and ENTERED this 5th day of February, 1996, at Tallahassee, Leon County, Florida.

LINDA M. RIGOT, 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 this 5th day of February, 1996.

APPENDIX TO RECOMMENDED ORDER DOAH CASE NO. 94-3214

1. Petitioner's proposed findings of fact numbered 2, 4-24, 26 and 27 have been adopted either verbatim or in substance.

2. Petitioner's proposed finding of fact numbered 1 has been rejected as not constituting a finding of fact.

3. Petitioner's proposed finding of fact numbered 3 has been rejected as being irrelevant to the issues involved herein.

4. Petitioner's proposed finding of fact numbered 25 has been rejected as not being supported by competent evidence.

COPIES FURNISHED:

Dr. Marm Harris Executive Director Board of Medicine

Agency for Health Care Administration 1940 North Monroe Street

Tallahassee, Florida 32399-0792

Joseph S. Garwood, Esquire

Agency for Health Care Administration 1940 North Monroe Street

Tallahassee, Florida 32399-0792

Richard Plagenhoef, M.D. Post Office Box 12131 Dallas, Texas 75225

Richard Plagenhoef, M.D. Post Office Box 2129

Cherokee, North Carolina 28789

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 larger period within which to submit written exceptions. You should contact the agency that will issue the final order in this case 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 in this case.

Docket for Case No: 94-003214

Orders for Case No: 94-003214