Burzynski Associate Zanhua Yi Facing Disciplinary Action

Stephen Barrett, M.D.


The Texas Medical Board has accused Zanhua Yi, M.D. (a/k/a/Zan Yi, M.D.) of violating the Medical Practice Act in connection with managing a patient who had metastatic kidney cancer. The board's complaint (shown below) alleges that Yi (a) ordered unnecessary laboratory tests, (b) exposed the patient to unacceptable toxicity by prescribing multiple drugs with overlapping toxicity profiles, (c) prescribed an off-label drug without medical justification, (d) failed to document any rationale for these actions., and (e) failed to obtain informed consent for simultaneous administration of two drugs. Yi works is a "senior oncologist" at the Burzynski Clinic, whose proprietor, Stanislaw Burzynski, M.D., is also facing disciplinary action.


HEARING CONDUCTED BY THE
TEXAS STATE OFFICE OF ADMINISTRATIVE HEARINGS
SOAH DOCKET NO. 503-14-4119. MD

LICENSE NO. N-9666

IN THE MATTER OF THE

COMPLAINT AGAINST:

ZANHUA YI, M.D.

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BEFORE THE

TEXAS MEDICAL BOARD

Filed .

COMPLAINT

TO THE HONORABLE TEXAS MEDICAL BOARD AND THE HONORABLE ADMINISTRATIVE LAW JUDGE TO BE ASSIGNED:

COMES NOW, the staff of the Texas Medical Board (Board), and files this Complaint against Zanhua Yi, M.D. (Respondent), based on Respondent's alleged violations of the Medical Practice Act (Act), Title 3, Subtitle B, Texas Occupations Code, and would show the following:

I. INTRODUCTION

The filing of this Complaint and the relief requested are necessary to protect the health and public interest of the citizens of the State of Texas, as provided in Section 151.003 of the Act.

II. PROCEDURAL BACKGROUND

1. Respondent is a Texas Physician and holds Texas Medical License No. N-9666, originally issued by the Board on May 2, 2011. Respondent's license was in full force and effect at all times material and relevant to this Complaint.

2. Respondent received appropriate notice of an Informal Settlement Conference. The Board complied with all procedural rules, including but not limited to, Board Rules 182 and 187, as applicable.

3. No agreement to settle this matter has been reached by the patties.

4. All jurisdictional requirements have been satisfied.

III. FACTUAL ALLEGATIONS

Board staff has received information and, based on that information, believes that Respondent has violated the Act. Based on such information and belief, Board Staff alleges:

1. Respondent treated Patient1 at the Burzynski Clinic for Patient's metastatic renal carcinoma on or about September 7, 2011 through on or about September 15, 2011.

1Identification of the Patient will be provided by separate document submitted under seal.

2. Patient underwent nephrectomy and adjuvant therapy for a chromophobe type renal cancer in 1994. Beginning with the first disease recurrence in 1997 and over the subsequent years, Patient underwent a sequence of therapies. Patient also had pre-existing renal disease.

3. Respondent ordered laboratory studies that had no impact on treatment of Patient. At Patient's first encounter with Respondent on or about September 7, 2011, Respondent ordered multiple studies, including an ECHO cardiogram, PET scan, requisitions for serum or plasma analysis and testing, and an amino acid profile for evaluation of nutritional status. Respondent also ordered other laboratory studies, including molecular diagnostics, nucleic acid probes, and O2 saturation tests. Respondent failed to document any medical rationale in Patient's medical record to medically justify the administration of the laboratory studies.

4. Respondent prescribed multiple targeted agents to Patient with similar, overlapping toxicity profiles with the potential for unacceptable toxicities. Specifically, Respondent prescribed both a tyrosine kinase inhibitor (Sunitinib) and a motor inhibitor (Everolimus), and directed Patient to take the drugs simultaneously.

5. Sunitinib and Everolimus are cancer treating agents that have a high propensity to cause diarrhea and painful inflammation and ulceration of the mucous membranes lining the digestive tract. Further, patients taking Everolimus are at risk of renal failure.

6. Respondent non-therapeutically prescribed a combination of two targeting agents in toxic doses, leading to an unacceptable risk of complications faced by Patient, including renal failure, as the patient had pre-existing renal disease.

7. Respondent failed to document any medical rationale in Patient's medical record for prescribing multiple targeted agents for a chromophobe type renal cancer.

8. Respondent failed to obtain informed consent from Patient for simultaneous intake of Sunitinib and Everolimus.

9. Respondent non-therapeutically prescribed phenylbutyrate, an off-label pharmaceutical, to treat Patient's renal cell cancer, without medical justification and without documenting any medical rationale in Patient's medical record.

IV. STATUTORY VIOLATIONS

The actions of Respondent specified above violate one or more of the following provisions of the Act:

1. Section 164.051(a)(1) of the Act authorizes the Board to take disciplinary action against Respondent based on Respondent's commission of an act prohibited under Section 164.052 of the Act.

2. Section 164.051 (a)(3) of the Act authorizes the Board to take disciplinary action against Respondent based on Respondent's violation of a Board Rule, specifically, Board Rule 165.1, requiring maintenance of adequate medical records.

3. Section 164.051(a)(6) of the Act authorizes the Board to take disciplinary action against Respondent based upon Respondent's failure to practice medicine in an acceptable professional manner consistent with public health and welfare, as defined by Board Rules: 190.8(1)(A), failure to treat a patient according to the generally accepted standard of care; 190.8(1)(B), negligence in performing medical services; 190.8(1)(C), failure to use proper diligence in one's professional practice; 190.8(1)(D), failure to safeguard against potential complications; 190.8(1)(G), failure to disclose reasonably foreseeable side effects of a procedure or treatment; 190.8(1)(H), failure to disclose reasonable alternative treatments to a proposed procedure or treatment; 190.8(1)(1), failure to obtain informed consent from the patient or other person authorized by law to consent to treatment on the patient's behalf before performing tests, treatments, or procedures; and 190.8(1)(K), prescribing or administering a drug in a manner that is not approved by the FDA for use in human beings or does not meet standards for off-label use, unless an exemption has otherwise been obtained from the FDA.

4. Section 164.052(a)(5) of the Act authorizes the Board to take disciplinary action against Respondent based upon Respondent's unprofessional or dishonorable conduct that is likely to deceive or defraud the public or injure the public, as provided by Section 164.053, or injure the public, as further defined by Board Rule 190.8(2)(J), providing medically unnecessary services to a patient.

5. Section 164.053(a)(1) Authorizes the Board to take disciplinary action against Respondent based on Respondent's commission of an act that violates state or federal law if the act is connected to the practice of medicine, specifically, Texas Health and Safety Code ยง481.129(c), related to prescribing controlled substances without a valid medical purpose.

6. Section 164.053(a)(5) of the Act authorizes the Board to take disciplinary action against Respondent based upon Respondent prescribing or administering a drug or treatment that is nontherapeutic.

7. Section 164.053(a)(6) of the Act authorizes the Board to take disciplinary action against Respondent based upon Respondent prescribing, administering, or dispensing in a manner inconsistent with public health and welfare, (A) dangerous drugs as defined by THSC Chapter 483; or (B) controlled substances scheduled in THSC Chapter 481.

V. AGGRAVATING FACTORS

Board Rule 190.15 provides that the Board may consider aggravating factors in reaching a determination of sanctions. In this case, the facts warrant more severe or restrictive disciplinary action. This case includes the following aggravating factor: harm to one or more patients.

VI. APPLICABLE STATUTES, RULES, AND AGENCY POLICY

The following statutes, rules, and agency policy are applicable to the procedures for this matter:

1. Section 164.007(a) of the Act requires that the Board adopt procedures governing formal disposition of a contested case before the State Office of Administrative Hearings.

2. 22 TEX. ADMIN. CODE, Chapter 187 sets forth the procedures adopted by the Board under the requirement of Section 164.007( a) of the Act.

3. 22 TEX. ADMIN. CODE, Chapter 190 sets forth aggravating factors that warrant more severe or restrictive action by the board.

4. 1 TEX. ADMIN. CODE, Chapter 155 sets forth the rules of procedure adopted by SOAH for contested case proceedings.

5. 1 TEX. ADMIN. CODE, Chapter 155.507, requires the issuance of a Proposal for Decision (PFD) containing Findings of Fact and Conclusions of Law.

6. Section 164.007(a) of the Act, Board Rule 187.37(d)(2) and Board Rule 190 et. seq., provides the Board with the sole and exclusive authority to determine the charges on the merits, to impose sanctions for violation of the Act or a Board rule, and to issue a Final Order.

VII. NOTICE TO RESPONDENT

IF YOU DO NOT FILE A WRITTEN ANSWER TO THIS COMPLAINT WITH THE STATE OFFICE OF ADMINISTRATIVE HEARINGS WITHIN 20 DAYS AFTER THE DATE OF RECEIPT, A DEFAULT ORDER MAY BE ENTERED AGAINST YOU, WHICH MAY INCLUDE THE DENIAL OF LICENSURE OR ANY OR ALL OF THE REQUESTED SANCTIONS, INCLUDING THE REVOCATION OF YOUR LICENSE. A COPY OF ANY ANSWER YOU FILE WITH THE STATE OFFICE OF ADMINISTRATIVE HEARINGS SHALL ALSO BE PROVIDED TO THE HEARINGS COORDINATOR OF THE TEXAS MEDICAL BOARD.

VIII. PRAYER

WHEREFORE, PREMISES CONSIDERED, Board staff requests that an administrative law judge employed by the State Office of Administrative Hearings conduct a contested case hearing on the merits of the Complaint, and issue a PFD containing Findings of Fact and Conclusions of Law necessary to support a determination that Respondent violated the Act as set forth in this Complaint.

Respectfully submitted,

TEXAS MEDICAL BOARD

CHRISTOPHER PALAZOLA
Litigation Manager

SUSAN RODRIGUEZ
Lead Attorney

BY: _________________________________
Rodney Montes, J.D., Staff
Attorney Texas State Bar No. 24042223
Telephone: (512) 305-7071
FAX # (512) 305-7007
333 Guadalupe, Tower 3, Suite 610
Austin, Texas 78701

Filed with the Texas Medical Board on June 14, 2014.

____________________
Mari Robinson, J.D.
Executive Director
Texas Medical Board

This page was posted on July 16, 2014.

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