Richie Shoemaker, M.D., Reprimanded

Stephen Barrett, M.D.


In March 2013, the Maryland State Board of Physicians reprimanded Ritchie Shoemaker, M.D. Shoemaker's Web site states that he retired from clinical practice on January 31, 2013. The consent order (shown below) states:

Shoemaker's Web site still offers online testing and consultations and solicits donations for his Center for Research on Biotoxin-Associated Illness, which it says has "a track record unequalled in the field of mold, Lyme and CFS." In 2006, the FDA ordered Shoemaker to stop using an unapproved drug in a research study.

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IN THE MATTER OF

RITCHIE C. SHOEMAKER, M.D.

Respondent.

License No. D24924

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BEFORE THE MARYLAND

STATE BOARD OF

PHYSICIANS

Case Numbers: 2010-0765 & 2010-0912

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CONSENT ORDER

On November 26, 2012, the Maryland State Board of Physicians (the "Board") charged Ritchie C. Shoemaker, M.D. (the "Respondent") (D.O.B. 06/13/1951), License Number 024924, under the Maryland Medical Practice Act (the "Act"), Md. Health Occ, Code Ann. ("H.O.") §§ 14-401 et seq. (2009 Repl.Vol.)

The pertinent provisions of the Act under H.O. § 14-404(a) provide as follows:

§ 14-404. Denials, reprimands, probations, suspensions, and revocations—Grounds.

(a) In general. Subject to the hearing provisions of § 14-405 of this subtitle, the Board, on the affirmative vote of a majority of the quorum, may reprimand any licensee, place any licensee on probation, or suspend or revoke a license if the licensee:

(22) Fails to meet appropriate standards as determined by appropriate peer review for the delivery of quality medical and surgical care performed in an outpatient surgical facility, office, hospital, or any other location in this State [.]

On February 6, 2013, a conference with regard to this matter was held before the Board's Case Resolution Conference ("CRC"). As a result of the CRC, the Respondent agreed to enter into this Consent Order, consisting of Findings of Fact, Conclusions of Law and Order.

FINDINGS OF FACT

1. At all times relevant hereto, the Respondent was and is licensed to practice medicine in the State of Maryland. The Respondent was originally licensed to practice medicine in Maryland on June 19, 1980. The Respondent also holds inactive medical licenses in North Carolina, Pennsylvania and Virginia.

2. The Respondent was board-certified in Family Medicine; however, his board-certification expired in 2006.

3. The Respondent maintains an office for the practice of medicine, the Chronic Fatigue Center, in Pocomoke City, Maryland.

Procedural History

4. By letter dated February 22, 2006, the Board notified the Respondent that it had received a complaint regarding the Respondent's medical practice. The Board further notified the Respondent that the complaint had been closed, but advised him that, "the Board has mandated protocols for alternative medicine practitioners to ensure that prospective patients are fully informed of the nature of your practice regarding alternative medical diagnoses and treatments."

5. On August 26, 2009, the Board issued to the Respondent an Advisory Letter. The Board notified the Respondent that an anonymous complaint received by the Board alleged that the Respondent was treating and prescribing for Lyme Disease over the internet. The Board voted to close the case but "strongly advised" the Respondent to comply with the Board's mandated protocols for alternative medicine practitioners to ensure that prospective patients are fully informed of the nature of his practice regarding alternative medical diagnoses and treatments.

Current Complaints

6. On or about April 16, 2010, the Board received a written complaint from an individual who was not a patient of the Respondent. The complainant alleged that the Respondent was soliciting prospective patients on a website that encourages the viewer to take an on-line diagnostic test. The complainant reported that he took the test which included very broad symptom responses. The complainant provided positive responses to a few of the items. Based on the responses, the website suggested that the complainant may be suffering from a biotoxin illness and further suggested that the complainant visit the Respondent's office. The complainant alleged that the Respondent cited "his own non-profit [organization] research to convince people to visit his private practice and purchase unnecessary tests."

7. The Board designated this complaint as Board Case Number 2010-0765.

8. On or about June 2, 2010, the Board received a complaint from a former patient of the Respondent regarding the Respondent's practice.

9. The Board designated this complaint as Case Number 2010-0912.

10. In furtherance of its investigation, the Board subpoenaed from the Respondent patient records and directed him to produce a summary of his care of each patient.

11 . The patient records and the Respondent's response were then referred to a peer review entity for review of the Respondent's practice. The results of the peer review are summarized below.

The Respondent's Practice

12. The Respondent's patients are generally self-selected; that is, they have identified themselves as suffering from health problems as a consequence of having been exposed to mold and have sought treatment from the Respondent after reading his website or other literature.

13. The Respondent has developed a treatment protocol for a diagnosis he calls Chronic Inflammatory Response Syndrome. The protocol includes the administration of cholestyramine1 as an initial step if removal from the suspected environmental trigger is not possible or ineffective.

1Cholestyramine is a bile acid sequestrant which binds acid in the gastrointestinal tract to prevent its reabsorption.

14. The Respondent enrolled several of the patients whose care was reviewed in an experimental protocol under the auspices of a legitimate Institutional Review Board.

Summary of Peer Review

15. The peer reviewers noted the following deficiencies in all of the cases they reviewed:

a. Off-label use of potentially toxic drugs (e.g., Actos2 and Rifampin,3). The drugs prescribed by the Respondent are potentially toxic when used for inappropriate purposes;

2Actos is a Type 2 diabetes medication that regulates blood sugar.
3Rifampin is used with other medications to treat tuberculosis and Neisseria meningitides (a type of bacteria that can cause meningitis.

b. The Respondent's documentation is not consistently legible;

c. The Respondent used diagnostic codes for conditions not evident in the patient's record to justify the laboratory studies. The Respondent justified many of the laboratory tests he ordered for each patient using the diagnostic code for "toxic encephalopathy, yet other than the patients' complaint of not thinking clearly, there is no evidence that the patients displayed any clinical signs of encephalopathy. Similarly, for all of the patients whose care was reviewed, the Respondent noted the IDC code for bronchitis (466.0) to justify spirometry; however, there was no evidence in the patients' record of bronchitis. The Respondent noted that IDC code for premature heart beats (427.61) to justify EKGs for each patient, however, there is no evidence of premature beats in the records;

d. The Respondent failed to document his treatment rationale for starting, adjusting or changing medications or dosages;

e. The Respondent failed to document complete problem lists and medication lists.

16. In addition to the above deficiencies, the Respondent prescribed Procrit (erythropoietin), a glycoprotein that stimulates red blood production, to a patient in a manner that was potentially dangerous to the patient. Procrit is typically prescribed to treat anemia. The patient signed an informed consent form that included the Food and Drug Administration "black box warning" that advised of "increased mortality, serious cardiovascular and thromboembolic events and tumor progression." The black box warning further advises the physician to individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 gm/dL.

17. According to the informed consent form, the Respondent was administering Procrit to "lower C4a and correct chemical disturbances in central nervous system."

18. The patient was not anemic; his hemoglobin was 14.6 grldL when the Respondent began administering Procrit.

19. The Respondent administered Procrit on five occasions, two to three days apart. The Respondent monitored the patient's hemoglobin after each Procrit injection; after the fifth injection, the patient's hemoglobin was 15.6 gr/dL. The Respondent failed to document in the patient's record that he discontinued the patient's Procrit after the fifth injection and his reason for doing so.

20. The practice deficiencies set forth in ¶¶16 - 19 are examples of the Respondent's failure to meet the standard of quality care.

CONCLUSIONS OF LAW

Based on the foregoing Findings of Fact, the Board concludes as a matter of law that the Respondent failed to meet the standard of quality care, in violation of H.O. § 14-404(a)(22). The Board dismisses the charge that the Respondent engaged in unprofessional conduct in the practice of medicine (H.O. § 14-404(a)(3)(ii).

ORDER

Based on foregoing Findings of Fact and Conclusions of Law, it is this 20th day of March, 2013, by a majority of the quorum of the Board considering this case:

ORDERED that the Respondent is REPRIMANDED; and it is further ORDERED that because the Respondent's medical practice is now closed, should the Respondent resume the practice of medicine in Maryland, he shall be placed on PROBATION for a minimum of two (2) years and until he fully and satisfactorily complies with all of following terms and conditions:

i. the Respondent shall notify the Board in writing prior to re­opening his office;

ii. prior to the resumption of practice, the Respondent shall obtain at his own expense a Board-approved practice monitor;

iii. for the first year of probation, the practice monitor will review on a monthly basis aspects of the Respondent's care including diagnosis, treatment and medications prescribed and appropriate referral to other medical practitioners;

iv. the Respondent shall ensure that the practice monitor submits to the Board a detailed report of hislher findings on a quarterly basis;

v. at the end of the first year of probation, the Board will determine whether the condition that the Respondent's practice be monitored on a monthly basis should be modified or terminated;

vi. The Respondent shall not require or solicit patients to make a contribution to his non-profit research fund.

ORDERED that the Respondent shall be subject to chart or peer review at the discretion of the Board during the probationary period; and it is further ORDERED that the Respondent shall comply with the Maryland Medical Practice Act and all laws, statutes and regulations pertaining to the practice of medicine; and it is further

ORDERED that the Respondent's failure to comply with any of the conditions of probation or this Consent Order shall be considered a violation of probation; and it further

ORDERED that if the Respondent violates any of the terms and conditions of probation or of this Consent Order, the Board, in its discretion, after notice and an opportunity for an evidentiary hearing before an Administrative Law Judge at the Office of Administrative Hearings if there is a genuine dispute as to the underlying material facts, or an opportunity for a show cause hearing before the Board, may impose any other disciplinary sanction for with the Board may have imposed, including a reprimand, probation, suspension, revocation andlor monetary fine, said violation being proven by a preponderance of the evidence; and it is further

ORDERED that two (2) years after the his probationary period begins, the Respondent may submit a written petition to the Board requesting termination of probation. After consideration of the petition, the probation may be terminated, through an order of the Board or designated Board committee. The Board, or designated Board committee, will grant the termination if the Respondent has fully and satisfactorily complied with all of the probationary terms and conditions and there are no pending complaints related to the charges; and it is further

ORDERED that the Respondent shall not petition the Board for early termination of the terms and conditions of this Consent Order; and it is further

ORDERED that the Respondent shall be responsible for all costs under this Consent Order; and it is further

ORDERED that this Consent Order shall be a public document pursuant to Md. State Gov't Code Ann. § 10-611 (2009 RepL Vol.).

Date: 3/21/13

_______________________
Carole J. Catalfo
Executive Director
Maryland State Board of Physicians

CONSENT

I, Ritchie C. Shoemaker, M.D., acknowledge that I am represented by counsel and have consulted with counsel before entering this Consent Order. By this Consent and for the purpose of resolving the issues raised by the Board, I agree and accept to be bound by the foregoing Consent Order and its conditions.

I acknowledge the validity of this Consent Order as if entered into after the conclusion of a formal evidentiary hearing in which I would have had the right to counsel, to confront witnesses, to give testimony, to call witnesses on my own behalf, and to all other substantive and procedural protections provided by the law. I agree to forego my opportunity to challenge these allegations. I acknowledge the legal authority and jurisdiction of the Board to initiate these proceedings and to issue and enforce this Consent Order. I affirm that I am waiving my right to appeal any adverse ruling of the Board that I might have filed after any such hearing.

I sign this Consent Order after having an opportunity to consult with counsel, voluntarily and without reservation, and I fully understand and comprehend the language, meaning and terms of the Consent Order.

Date: 2/11/13

__________________________
Richie C. Shoemaker, M.D.
Respondent

This page was posted on October 17, 2013.

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