STATE OF FLORIDA BOARD OF OSTEOPATHIC MEDICINE. vs. Case No.: License No.: OS 5165 FINAL ORDER

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1 Final Order No. DOH S -MQA FILED DATE ArilL2018 Department of Health STATE OF FLORIDA BOARD OF OSTEOPATHIC MEDICINE uty Agency Clerk DEPARTMENT OF HEALTH, Petitioner, vs. Case No.: License No.: OS 5165 MARK G. KANTZLER, D.O., Respondent, FINAL ORDER This matter came before the Board of Osteopathic Medicine (Board) at a dulynoticed public meeting on November 17, 2017, in Jacksonville, Florida, to consider the Respondent's offer to voluntarily relinquish his license to practice osteopathic medicine in the State of Florida. A copy of the Respondent's Voluntary Relinquishment of License is attached hereto as Exhibit "A." Said written offer of relinquishment specifically provides that Respondent understands that acceptance of the Voluntary Relinquishment shall be construed as disciplinary action against Respondent's license and Respondent agrees never again to apply for licensure as an osteopathic physician in the State of Florida. Upon consideration of the written offer of voluntary relinquishment, the charges set forth in the Amended Administrative Complaint filed in this matter on July 13, 2015, attached hereto as Exhibit "B," and the other documents of record, and being otherwise advised in the premises,

2 IT IS HEREBY ORDERED that the voluntary relinquishment of the license of Mark G. Kantzler, D.O. to practice osteopathic medicine in the State of Florida is accepted and shall constitute discipline upon his record. This Final Order shall become effective upon filing with the Clerk for the Department of Health. DONE AND ORDERED this (14 day of Watt&, 2013?.' BOARD OF OSTEOPATHIC MEDICINE Kama Monroe, J.D., Executive Director on behalf of Michelle Mendez, D.O., Chair CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of the foregoing has been furnished by U.S. Mail to Mark G. Kantzler, D.O., P.O. Box 1619, Largo, FL ; and by to Donna C. McNulty, Senior Assistant Attorney General, at Donna.McNulty@myfloridalegal.com; and Matthew Witters, Assistant General Counsel, at Matthew.Witters@flhealth.gov; this I Li day of, 201? Deputy Agency Clerk 2

3 Mission: To protect, promote & improve the health of all people in Florida through integrated state, county & community efforts. HEALTH Vision: To be the Healthiest State in the Nation Rick Scott Governor Celeste Philip, MD, MPH Surgeon General and Secretary INTEROFFICE MEMORANDUM DATE: January 9, 2018 TO: FROM: SUBJECT: Adrienne Rodgers, J.D., Bureau Chief Bureau of Health Care Practitioner Regulation Kama Monroe, J.D., Executive Director Boards of Acupuncture, Massage Therapy, Osteopathic Medicine, Speech- Language Pathology & Audiology and the Council of Licensed Midwifery Delegation of Authority This is to advise that while I am out of the office January 9, 2017, William Spooner has delegated authority to serve as Acting Executive Director for the Boards of Acupuncture, Massage Therapy, Osteopathic Medicine, Speech-Language Pathology & Audiology and the Council of Licensed Midwifery. Mr. Spooner can be reached at KM/dg Florida Department of Health Division of Medical Quality Assurance 4052 Bald Cypress Way, Bin C-00 Tallahassee, FL PHONE: (850) FAX (850) Accredited Health Department blic Health Accreditation Board

4 STATE OF FLORIDA DEPARTMENT OF HEALTH FILED DEPARTMENT OF HEALTH DEPUTY CLERK CLERK Amber Greene DATE SEP DEPARTMENT OF HEALTH, Petitioner, DOH Case No.: V. MARK G. KANTZLER, D.O. Respondent I VOLUNTARY RELINQUISHMENT OF LICENSE Respondent, MARK G. KANTZLER, D.O. license no. 5165, hereby voluntarily relinquishes Respondent's license to practice osteopathic medicine In the State of Florida and states as follows: 1. Respondent's purpose In executing this Voluntary Relinquishment is to avoid further administrative action with respect to this cause. Respondent understands that acceptance by the Board of Osteopathic Medicine (hereinafter the Board) of this Voluntary Relinquishment shall be construed as disciplinary action against Respondent's license pursuant to Section (1)(t), Florida Statutes. 2. Respondent agrees not to reapply for licensure pursuant to Chapter 459 in the State of Florida. z'd V-LZI. Jelueo isolams sseiewm dzz:rol 1, des Exhibit A

5 3. Respondent agrees to voluntarily cease practicing osteopathic medicine in Florida immediately upon executing this Voluntary Relinquishment Respondent further agrees to refrain from the practice of osteopathic medicine In Florida until such time as this Voluntary Relinquishment is presented to the Board and the Board issues a written final order in this matter. 4. In order to expedite the consideration and resolution of this action by the Board in a public meeting, Respondent, being fully advised of the consequences of so doing, hereby waives the statutory privilege of confidentiality of Section (10), Florida Statutes, and waives a determination of probable cause by the Probable Cause Panel, or the Department when appropriate, pursuant to Section (4), Florida Statutes, regarding the complaint, the investigative report of the Department of Health, and all other information obtained pursuant to the Department's investigation of the above-styled action. By signing this waiver, Respondent understands that the record and the complaint become public record and remain public record and that information is immediately accessible to the public. Section (10), Florida Statutes LZL Awe 1E0164ne EsEle11111 d61:80 L i des

6 5. Upon the Board's acceptance of this Voluntary Relinquishment, Respondent agrees to waive all rights to seek judicial review of, or to otherwise challenge orcontest the validity of, this Voluntary Relinquishment and of the Final Order of the Board incorporating this Voluntary Relinquishment. 6. Petitioner and Respondent hereby agree that upon the Board's acceptance of this Voluntary Relinquishment, each party shall bear its own attorney's fees and costs related to the prosecution or defense of this matter. 7. Respondent authorizes the Board to review and examine all Investigative file materials concerning Respondent in connection with the Board's consideration of this Voluntary Relinquishment Respondent agrees that consideration of this Voluntary Relinquishment and other related materials by the Board shall not prejudice or preclude the Board or any of its members, from further participation, consideration, or resolution of these proceedings if the terms of this Voluntary Relinquishment are not accepted by the Board. DATED this 21 I, vd P-LU _value leomins eseieuu 1,4 des

7 STATE OF Florida COUNTY OF: - 1 Nato.% Before me, personally appeared 016.*,_ 1.4 arkele whose identity is known to me by krserck type of identification) and who, under oath, ad4ovvledges that his signature appears above. Sworn to and subscribed before me this day of $ye eke, NOTARY PUBLIC My Commission Expires:. ERICA CALIONS Nary Rails - Statist Hama Comotsiisa 41 I* 141'047 My imm. Espizaw ilar itegy Asa l E=rit 4 s'd VIZL Jews dear ns see' dm: 1, 4Z des

8 STATE OF FLORIDA DEPARTMENT OF HEALTH FILED DEPARTMENT OF HEALTH DEPUTY CLERK CLERK anget Sandeee DATE JUL DEPARTMENT OF HEALTH, PETITIONER, V. CASE NO.: MARK G. KANTZLER, D.O., RESPONDENT. AMENDED ADMINISTRATIVE COMPLAINT COMES NOW, Petitioner, Department of Health, by and through its undersigned counsel, and files this Amended Administrative Complaint before the Board of Osteopathic Medicine against the Respondent, Mark G. Kantzler, D.O., and in support thereof alleges: 1. Petitioner is the state agency charged with regulating the practice of osteopathic medicine pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 459, Florida Statutes. 2. At all times material to this Amended Administrative Complaint, Respondent was a licensed osteopathic physician within the State of Florida, having been issued license number OS Exhibit B

9 3. Respondent's address of record is P.O. Box 1619, Largo, Florida At all times material to this Amended Administrative Complaint, Respondent was the registered medical director of the "Advanced Wellness Center", located at 2033 Wood Street, Number 210, Sarasota, Florida At all times material to this Amended Administrative Complaint, the "Advanced Wellness Center" was a "clinic" as licensed in Chapter , Florida Statutes (2012). 6. Patient M.M. was a 69 year old female with oxygen dependent Chronic Obstructive Pulmonary Disease (COPD) emphysema and lung cancer in remission. 7. On or about June 11, 2013, patient M.M. consulted Advanced Wellness Center regarding stem cell treatment for her COPD. 8. Respondent failed to adequately explain that the intravenous administration of adipose derived stem cells has no medical or scientific value to treat COPD. DOH V. Mark G. Kantzler, D.O. 2

10 9. Respondent failed to adequately explain that the intravenous administration of adipose derived stem cells had no proper medical foundation for success. 10. Respondent failed to adequately explain that the procedure was not accepted as a proven treatment in the State of Florida. 11. On or about June 17, 2013, Respondent performed a stem cell procedure by removing fatty adipose tissue from patient M.M. through liposuction, spinning the tissue to ostensibly isolate stem cells, and reinjecting the solution into patient M.M. intravenously (IV). 12. During the administration of the IV Respondent and a Chiropractor, J.L., noticed and attempted to manually separate a red clump with their hands. 13. During the administration of the IV, patient.'s head began to sway back and forth and she lost consciousness. 14. Patient M.M. continued to exhibit an abnormal physical response to the treatment. 15. Respondent failed to call 911, 16. Patient M.M.'s husband called 911 paramedics, requesting an ambulance to transport patient M.M to the hospital. DOH v. Mark G. Kantzler, D,O. Case No,

11 17. Patient M.M.'s husband gave the phone to the Respondent. The Respondent stated that he told patient M.M.'s husband to not call 911. Respondent walked away from the scene, 18. Chiropractor J.L. got on the phone with the 911 operator. 19. J.L. stated, "We've got things under control though... we're in the middle of a procedure here." 20. J.L. stated to the 911 operator, "we've just requested that he [patient M.M.'s husband] not call you guys... the patient's actually looking a lot better. It was just a... she hasn't slept all week... and... she got vasovagal... so we... feel that we have it under control here." 21. The 911 operator asked, "And you don't need an ambulance?" J.L. stated, "No." 22. Patient M.M.'s heart stopped. 23. Paramedics attempted to provide life-saving procedures. Patient M.M. was declared dead at approximately 6:16 p.m. on June 17, Respondent was the certifying physician for patient M.M.'s death certificate. 25. Respondent did not send patient M.M. to be autopsied. DOH V. Mark G. Kantzler, D.O. Case No

12 26. Respondent listed causes of death to include "cardiopulmonary arrest" and "COPD/ Emphysema." 27. Respondent did not submit a 15 day Adverse Incident Report to the Agency for Health Care Administration (AHCA). 28. Respondent's medical records did not contain medical justification for the intravenous administration of adipose derived stem cells as a treatment for patient M.K's COPD. 29. Respondent did not explain to patient M.M. the risks associated with the procedure. 30. Respondent did not obtain informed consent from patient M.M. 31. Respondent's treatment of patient M.M.'s COPD by the intravenous administration of adipose derived stem cells as a treatment for COPD had no substantial medical and / or scientific value. 32. Respondent fell below the standard of care by performing an unproven experimental procedure, by having inadequate training to perform the procedure, by failing to call 911 and/or by failing to properly aid the assistance and arrival of paramedics, and by failing to send the deceased patient M.M. to the medical examiner. DOH v. Mark G. Kantzler, 0.0.

13 COUNT I 33. Petitioner realleges and incorporates paragraphs one (1) through thirty-two (32), as if fully set forth herein. 34. Section (1)(x), Florida Statutes (2012), allows the Board of Osteopathic Medicine to impose discipline for committing medical malpractice as defined in Section , Florida Statutes. 35. "Medical malpractice" is defined in Section (1)(e), Florida Statutes (2012), as the "failure to practice medicine in accordance with the level of care, skill, and treatment recognized in general law related to health care licensure." 36. For purposes of Section (1)(x), Florida Statutes (2012), the Board shall give great weight to the provisions of Section , Florida Statutes (2012), which provides: The prevailing professional standard of care for a given health care provider shall be that level of care, skill, and treatment which, in light of all relevant surrounding circumstances, is recognized as acceptable and appropriate by reasonably prudent similar health care providers. DOH V. Mark G. KantrJer, D.O. 6

14 37. Respondent committed medical malpractice in his care of Patient M.M. in one or more of the following manners: a. by performing a procedure that had no substantial medical and scientific value for the treatment of patient M.M.'s COPD; b. by performing a procedure that had no proper medical foundation for success; c. by performing a procedure that was entirely experimental and not an accepted or proven treatment in the State of Florida; cl1 by performing a procedure that was dangerous and unwarranted; e. by performing a procedure that was medically unnecessary and dangerous; f. by performing a procedure that placed the patient at an inappropriate risk of death and/or serious injury; g. by injecting or causing the injection of an unknown material into M.M.'s circulation without any prior objective knowledge of the material's properties or the risks to the patient; h. by failing to perform an adequate medical examination; DOH v. Mark G. Kantzier, 7

15 I. by failing to call 911 at the onset of signs of cardiac arrest; and/or j. by failing to send the deceased patient M.M. to the medical examiner. 38. Based on the foregoing, Respondent violated Section (1)(x), Florida Statutes (2012), by committing medical malpractice. COUNT II 39. Petitioner realleges and Incorporates paragraphs one (1) through thirty-two (32), as if fully set forth herein, 40. Section (1)(s), Florida Statutes (2012), subjects a licensee to discipline for performing professional services which have not been duly authorized by the patient or client or his or her legal representative except as provided in s , s , or s Prior to administering the adipose derived stem cells intravenously into patient M.M., Respondent failed to adequately explain to patient M.M. one or more of the following: a. That the intravenous administration of adipose derived stem cells has no medical or scientific value to treat COPD; DOH v. Mark G. Kantzler, 0.0.

16 b. That the intravenous administration of adipose derived stern cells had no proper medical foundation for success; and/or C. That the procedure was not accepted as a proven treatment in. the State of Florida. 42. Respondent failed to obtain proper informed consent from patient M.M., by failing to make proper disclosures, indicating that patient M.M. was sufficiently educated on the risks, benefits, and alternatives to the proposed treatment of intravenous administration of adipose derived stem cells for the treatment of COPD. 43. Based on the foregoing Respondent violated Section (1)(s), Florida Statutes (2012). COU NT III 44. Petitioner realleges and incorporates paragraphs one (1) through thirty-two (32), as if fully set forth herein. 45. Section (1)(bb), Florida Statutes (2012), provides that performing or attempting to perform health care services on the wrong patient, a wrong-site procedure, a. wrong procedure, or an unauthorized procedure or a procedure that is medically unnecessary or otherwise DOH v. Mark G. Kantzler,

17 unrelated to the patient's diagnosis or medical condition is grounds for disciplinary action. 46. Respondent performed a wrong procedure, an unauthorized procedure, a medically unnecessary procedure or a procedure unrelated to patient's diagnosis or medical condition by intravenously administering adipose derived stems cells into patient M.M. to treat COPD. 47. Based on the foregoing, Respondent violated Section (1)(bb), Florida Statutes (2012). COUNT IV 48. Petitioner realleges and incorporates paragraphs one (1) through thirty-two (32), as if fully set forth herein. 49. Section (1)(g), Florida Statutes (2012), provides that failing to perform any statutory or legal obligation placed upon a licensed osteopathic physician is grounds for discipline. 50. Section (1), Florida Statutes (2012), states that each clinic shall appoint a medical director or clinic director who shall agree In writing to accept legal responsibility for certain activities. 51. Section (1)(f), Florida Statutes (2012), lists that one such responsibility is to ensure compliance with the recordkeeping, office DON v. Mark G. Kantzler, D.O. 10

18 surgery, and adverse incident reporting requirements of chapter 456, the respective practice acts, and rules adopted under this part and part 11 of chapter Section (1), Florida Statutes (2012), provides that any adverse incident that occurs on or.after January 1, 2000, in any office maintained by an osteopathic physician for the practice of osteopathic medicine which is not licensed under chapter 395 must be reported to the department in accordance with the provisions of this section. 53. Section (3), Florida Statutes (2012), provides that the required notification to the department must be submitted in writing by certified mail and postmarked within 15 days after the occurrence of the adverse incident. 54. Section (4)(a), Florida Statutes (2012), provides that "adverse incident" includes "the death of a patient." 55. As the acting medical director of Advanced Wellness Center, Respondent was required to submit an adverse incident report within fifteen days of the death of patient M.M. 56. Respondent failed to submit an adverse incident report within fifteen days of the death of patient M.M. DOH v. Mark G. Kantzler, D.O. 11

19 57. Based on the foregoing, Respondent violated Section (1)(g), Florida Statutes (2012), by violating Section (1), Florida Statutes (2012). COUNT V 58. Petitioner realleges and incorporates paragraphs one (1) through thirty-two (32), as if fully set forth herein. 59. Section (1)(o), Florida Statutes (2012), provides that failing to keep legible, as defined by department rule in consultation with the board, medical records that identify the licensed osteopathic physician or the osteopathic physician extender and supervising osteopathic physidan by name and professional title who is or are responsible for rendering, ordering, supervising, or billing for each diagnostic or treatment procedure and that justify the course of treatment of the patient, including, but not limited to, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; and reports of consultations and hospitalizations is grounds for discipline. 60. Respondent failed to keep legible records that justified the course of treatment of patient M.M. DOH v. Mark G. Kantzler, D.O. 12

20 61. Based on the foregoing, Respondent violated Section (1)(o), Florida Statutes (2012). WHEREFORE, the Petitioner respectfully requests that the Board of Osteopathic Medicine enter an order imposing one or more of the following penalties: permanent revocation or suspension of Respondent's license, restriction of practice, imposition of an administrative fine, issuance of a reprimand, placement of the Respondent on probation, corrective action, refund of fees billed or collected, remedial education and/or any other relief that the Board deems appropriate. SIGNED this day of John H. Armstrong, MD, FACS State Surge, General and Secretary of Health Lucas L. May Assistant General Counsel DOH Prosecution Services Unit 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida Florida Bar No.: (850) (850) Facsimile Lucas.May@flhealth.gov /LLM PCP: Tu-t PCP Members: /arylec 41,16060ki O.c o,. /4/14.G he a rick 2., DOH v. Mark G. Kantzier, D.O. 13

21 NOTICE OF RIGHTS Respondent has the right to request a hearing to be conducted in accordance with Section and , Florida Statutes, to be represented by counsel or other qualified representative, to present evidence and argument, to call and cross-examine witnesses and to have subpoena and subpoena duces tecum issued on his or her behalf if a hearing is requested. NOTICE REGARDING ASSESSMENT OF COSTS Respondent is placed on notice that Petitioner has incurred costs related to the investigation and prosecution of this matter. Pursuant to Section (4)1 Florida Statutes, the Board shall assess costs related to the investigation and prosecution of a disciplinary matter, which may include attorney hours and costs, on the Respondent in addition any other discipline imposed. Do1-1 v. Mark G. Kantzler, D.O. 14