In the mid-1990s, the Michigan Board of Medicine charged Joseph Natole, Jr. with improperly treating 37 patients for Lyme disease. Following an administrative hearing, the Board concluded that Natole had violated the public health code with respect to all of the patients. Natole appealed to a state court, which upheld the Board’s findings except in the case of patient C.W., where the judge felt that the board had not sufficiently documented its reasoning. When the case was returned to the board, it withdrew the charges related to that patient. In 1998, Natole signed a consent agreement under which he did not contest the other charges and agreed to (a) have his license suspended for three months, (b) pay a $50,000 fine, (c) take a 3-month educational program, and (d) serve two years on probation after the program was completed.
STATE OF MICHIGAN
DEPARTMENT OF COMMERCE
BUREAU OF OCCUPATIONAL AND PROFESSIONAL REGULATION
B OARD OF MEDICINE
|In the Matter of
JOSEPH NATOLE, JR., M.D.
Docket No. 94-0121
SUPERSEDING ADMINISTRATIVE COMPLAINT
The People of the State of Michigan, by Attorney General Frank J. Kelley, by Assistant Attorney General Phillip I. Frame, file this complaint against Joseph Natole, Jr,, M,D, (ResponÂdent), alleging upon information and belief as follows:
1. The Board of Medicine (Board), an administrative agency established by the Public Health Code, 1978 PA 368, as amended; MCL 333.1101 et seq; MSA 14,15(1101) et seq, is empowered to discipline licensees thereunder.
2. Respondent is currently licensed to practice mediÂcine pursuant to the Public Health code, supra.
3. Section 16221(a) of the Public Health Code, supra, provides the Board with authority to take disciplinary action against Respondent for a violation of general duty, consisting of negligence or failure to exercise due care, whether or not injury results, and/or a conduct, practice, or condition which impairs, or may impair, the ability to safely and skillfully practice the health profession.
4, Section 1622l(b)(i) of the Public Health Code, supra, provides the Board with authority “to take disciplinary action against Respondent for incompetence, defined at section 16106(1) of the Public Health Code as “a departure from, or failÂure to conform to, minimal standards of acceptable and prevailing practice for the health profession, whether or not actual injury to an individual occurs.”
5. At all times pertinent hereto, Respondent was board certified in family practice only, and did not possess board cerÂtification in either internal medicine or neurology, or any subÂspecialty training or certification in infectious diseases or rheumatology.
6. At all times pertinent hereto, Respondent held himÂself out to the public and the conununity at large as a specialist in the treatment and diagnosis of Lyme disease. Respondent widely advertised his practice as the Midwest Lyme Disease Clinic.”
7, Dorlan’s lllustrated Medical Dictionary, 27th ediÂtion, defines Lyme disease as a recurrent multi-systemic disorder first reported in Old Lyme, Connecticut, beginning with lesions of erythema chronicum migrans and followed by arthritis of the large joints, myalgia, malaise and neurologic and cardiac manifestations. It is caused by the spirochete Borrulla burgdorferi, with the vector being the tick ixodes dammini. Called also Lyme arthritis.
8. As a result of five complaints registered with the Department of Commerce, Bureau of Occupational and Professional Regulation, five separate investigation interviews were conducted with Respondent. During those interviews, medical records were obtained of 31 of Respondent’s patients who had previously been diagnosed as having Lyme disease.
9, According to said patient records, Respondent has diagnosed Lyme disease in the following patients (initials will be used to protect privacy):
|L.R.||Congenital Lyme disease||2/28/90|
|M.R., Sr.||Lyme disease||2/26/90|
|M.R., Jr.||Lyme disease||2/28/90|
|J.S.||Possible congenital Lyme disease
|J.V.||Probable Lyme disease,
|N.W.||Probable Lyme disease||3/10/91|
|K.W.||Possible Lyme disease||3/27/90|
|M.P.||Possible to probable Lyme disease||4/14/92|
10. Respondent’s clinical techniques, methodology and judgment in respect to the diagnosis or Lyme disease in the aforesaid patients were negligent, incompetent, and below minimal standards of acceptable medical practice in the diagnosis of Lyme disease for the following reasons:
A. Respondent’s use of a Lyme disease questionnaire at the initial interview and examination conferÂence, prior to examination of the patient, is inaccurate and misleading, tending to lead to overdiagnosis of Lyme disease due to the nature of the questions asked in said questionnaire;
B. Respondent’s Lyme disease questionnaire itself is deficient, inaccurate and misleading in that said questionnaire includes a multiplicity of subjective comÂplaints which may be descriptive of several disease proÂcesses, tending to lead to overdiagnosis of Lyme disease if full validity is given to the subjective complaints described in said questionnaire;
C. Respondent’s use of a point scale established by the National Lyme Borreliosis Foundation (NLBF), is itself misleading and inaccurate due to Respondent’s tendency to interpret vague, non-specific, subjective symptomatology described in the Lyme disease questionÂnaire as positive or confirmatory of Lyme disease;
o. Respondent’s diagnosis of Lyme disease in multiple patients despite no historical avidence of traÂvel or residence in an endemic area of Lyme disease or geographic area where tick infestation is known to exist;
E. Respondent’s diagnosis of Lyme disease despite physical examination findings not suggestive, supportive or diagnostic of Lyme disease;
F. Respondent’s diagnosis of Lyme disease despite having direct knowledge of the patient having previously been diagnosed with another disease process which might explain clinic symptomatology, that diagnosis being made prior to the patient’s first clinical treatment with Respondent;Â·
G. Respondent’s diagnosis of Lyme disease in nuÂmerous patients despite completely negative Lyme disease laboratory studies, i.e., ELISA, Western Blot, ISA (seronegative patient);
H. Respondent’s diagnosis of Lyme disease using Lyme disease laboratory studies which are from an outÂside laboratory performed prior to Respondent’s first contact with the Lyme patient without verification of the reliability of said laboratory testing;
I. Respondent’s diagnosis of Lyme disease using a single borderline and/or equivocal Lyme disease laboraÂtory study which was interpreted by Respondent in numerÂous patients to have been positive;
J. Respondent’s diagnosis of Lyme disease using a single positive laboratory study and/or result not supÂported by clinical examination, history and/or other laboratory results.
K. Respondent’s diagnosis of Lyme disease using investigational urine antigen test results which were below laboratory cutoff for positive result or, in at least one case, contradicted by a simultaneous elevated total urine protein level indicative of a false positive test.
L. Respondent’s failure to perform a lumbar puncÂture spinal tap to determine cerebral-spinal abnormaliÂties indicative of late neurologic Lyme disease.
11. Respondent’s clinical techniques, methodology and judgment in respect to his treatment modalities of Lyme disease in the aforesaid patients were negligent, incompetent and below minimal standards of acceptable medical practice in.the following respects:
A. Respondent’s treatment regime of prescribing oral antibiotics as a method of confirming a diagnosis of Lyme disease;
B, Respondent’s treatment regime of prescribing oral antibiotics beyond two to three weeks departs from generally accepted medical practice and treatment of Lyme disease;
C. Respondent’s prescribing I.V., catheter and home I,V. infusion treatment modalities beyond two to four weeks departs from generally accepted medical pracÂtice and treatment of Lyme disease;
D. Respondent’s use of a “Jarisch-Herxheimer” reÂactiou as a method of gauging response to antibiotic therapy is inconsistent with the known pathophysiology of “Jarisch-Herxheimer” reaction process, and departs from generally accepted medical practice and treatment Â of Lyme disease;
E, Respondent’s use of a methodology of symptom improvement after initiation of antibiotic therapy as a justification for continuation of oral therapy after a standard course of r.v. therapy, or after prolonged courses of I.V. antibiotic therapy, is inconsistent with generally accepted medical practice in the treatment of Lyme disease since it is generally known that in most Lyme patients the disease process itself will continue to improve after initiation of a standard course of antibiotic therapy, i.e., three to four weeks oral, and two to four weeks I.V., and that persistent nonspecific symptomatology is unlikely to respond to further courses of antibiotic therapy;
F, Respondent’s practice of switching from one I.V. antibiotic (Rocephin) to another (Claforan) due to lack of symptom response is contrary to generally accepted medical treatment of Lyme disease since both Rocephin and Claforan contain substantially similar cheÂmical properties;
G, Respondent’s practice of combining oral and I.V. antibiotic therapy concurrently in some patients departs from generally accepted medical treatment of Lyme disease;
H. Respondent’s prescribing of Claforan in one patient resulted in a pruritic rash and his subsequent prescribing of Rocephin to the same patient resulted in a severe allergic reaction. Respondent’s failure to comprehend the potential for allergic reaction in this patient following the initial reaction to Claforan deÂparts from generally accepted medical treatment;
I. Respondent’s practice of prescribing antibiotic therapy, oral and I.V., for patients wrongly diagnosed with Lyme disease in the first place was unnecessary treatment and departed from generally accepted medical treatment of Lyme disease;
J. Respondent’s practice of using response to antibiotic therapy as a method of confirming an original diagnosis of Lyme disease in patients with atypical subÂjective complaints is contrary to generally accepted medical treatment of Lyme disease;
K, Respondent’s practice of ruling out the diagnoÂsis of Lyme disease in certain patients where there is a lack of complete resolution of symptoms following iniÂtiation of antibiotic therapy is contrary to generally accepted medical treatment of Lyme disease since it is generally known that some patients will automatically and gradually improve on their own even after the disÂcene inuance of antibiotic therapy.
Respondent’s diagnosis and treatment of Lyme disease as set forth above constitutes violation of section 1622l(a) of the Public Health Code, supra.
Respondent’s diagnosis and treatment of Lyme disease as set forth above constitutes violation of section l622l(b)(.i) of the Public Health Code, supra.
FURTHER, the administrative complaint previously filed against Respondent by the Attorney General’s office on November l, 1993, is hereby WITHDRAWN and replaced in full by this superseding complaint.
FRANK J. KELLEY
Phillip I. Frame
Assistant Attorney General
Healtrh Professionals Division
P.O. Box 30212
Lansing, Michigan 48909
Telephone: (517) 373-1146
DATED: Â Â May 10, 1994