HEARING CONDUCTED BY THE TEXAS STATE OFFICE OF ADMINISTRATIVE HEARINGS SOAH DOCKET NO. 7 .MD TEXAS MEDICAL LICENSE NO. N-9666 IN THE MATTER OF THE BEFORE THE COMPLAINT AGAINST ZANHUA YI, MD. TEXAS MEDICAL BOARD 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 ?les 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 ?ling 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 7 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. I i 3. No agreement to settle this matter has been reached by the parties. 4. All jurisdictional requirements have been satis?ed. Page 1 of8 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 Patienti at the Clinic for Patient?s metastatic renal carcinoma on or about September 7, 2011 through on or about September 15, 2011. 2. Patient underwent nephrectomy and adjuvant therapy for a chromophobe type renal cancer in 1994. Beginning with the ?rst disease recurrence in 1997 and over the subsequent years, Patient underwent a sequence of therapies. Patient also had pre-cxisting renal disease. Respondent ordered laboratory studies that had no impact on treatment of Patient. At Patient?s ?rst 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 pro?le for evaluation of nutritional status. Reapondent also ordered other laboratory studies, including molecular diagnostics, nucleic acid probes, and 02 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 pro?les with the potential for unacceptable toxicities. Speci?cally, Respondent prescribed both a tyrosine kinase inhibitor (Sunitinib) and a motor inhibitor (Everolirnus), 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 preexisting renal disease. Identi?cation of the Patient will be provided by separate document submitted under seal. Page 2 of 8 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 justi?cation and without documenting any medical rationale in Patient?s medical record. IV. STATUTORY VIOLATIONS The actions of Respondent speci?ed above violate one or more of the following provisions of the Act: 1. Section 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 of the Act authorizes the Board to take disciplinary action against Respondent based on Respondent?s violation of a Board Rule, speci?cally, Board Ruie 165.1, requiring maintenance of adequate medical records. 3. Section 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: failure to treat a patient according to the generally accepted standard of care; negligence in performing medical services; failure to use proper diligence in one?s professional practice; failure to safeguard against potential complications; failure to disclose reasonably foreseeable side effects of a procedure or treatment; failure to disclose reasonable alternative treatments to a proposed procedure or treatment; 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 prescribing or administering a drug in a manner that Page 3 of 8 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 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 de?ned by Board Rule providing medically unnecessary services to a patient. 5. Section 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 related to prescribing controlled substances Without a valid medical purpose. 7 6. Section 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 of the Act authorizes the Board to take disciplinary aetion against Respondent based upon Respondent prescribing, administering, or dispensing in a manner inconsistent with public health and welfare, (A) dangerous drugs as de?ned 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 Of?ce of Administrative Hearings. Page 4 of8 2. 22 TEX. ADMIN. CODE, Chapter 187 sets forth the procedures adepted 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. I 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 (PF D) containing Findings of act and C(mclusions of Law. 6. Section 164.007(a) of the Act, Board Rule 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. PRAYER WHEREFORE, PREMISES CONSIDERED, Board staff requests that an administrative law judge employed by the State Of?ce 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. Page 5 of8 Respectfully submitted, TEXAS MEDICAL BOARD CHRISTOPHER PALAZOLA Litigation Manager SUSAN RODRIGUEZ Lead Attorney ?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 THE STATE OF TEXAS COUNTY OF TRAVIS AND SWORN to before me by the said Rodney Montes, .D., on UUNE I7 2014. Notary Public, State of Texas 1 cusmecm LESHAE CADDELL . of; Notary Public. State of Texas My Commission Expires ?3,353,? May 12. 2018 - Page 6 of 8 Filed with the Texas Medical Board on mm 0, 2014. Texas Medical Board Page 7 of 8 CERTIFICATE OF SERVICE On this 2 /day of June, 2014, I certify that a true and correct copy of this Complaint has been served on the following individuals at the locations and the manner indicated below. Via Email to: docketing??soah.state.tx.us Docket Clerk State Of?ce of Administrative Hearings 300 West 15?h #504 . Austin, Texas 78701 Via Via Certi?ed Mail and First Class Mail Zanhua Yi, MD. 9432 Katy Freeway Houston, TX 77055 Via Certified Mail and Fax Transmission to: (916) 492-6039 Richard A. Jaffe 1825 Glenn Place Davis, CA 95616 By Hand Delivery: Sonja Aurelius Hearings Coordinator Texas Medical Board 333 Guadalupe, Tower 3, Suite 610 Austin, Texas 78701 ney Montest. Page 8 of 8