Zannos G. Grekos, M.D.
Facing Disciplinary Action

Stephen Barrett, M.D.


Zannos G. Grekos, M.D., is facing disciplinary action by the Florida Department of Health. Grekos practices at the Regence Heart and Vascular Institute in Bonita Springs, Florida and directs the Regenocyte Therapeutic Stem Cell Clinical Center in Naples, Florida. The administrative complaint (shown below) indicates that the Health Department began investigating Grekos in 2010 after one of his patients died following an injection bone marrow material into an artery in her neck. In February 2011, it issued an emergency order prohibiting him from continuing to provide stem cell therapy. The order stated that injection of bone marrow material directly into the carotid artery had "no substantiated medical and scientific value to treat the patient's peripheral neuropathy" and could be "extremely dangerous." A few weeks later, according to a report by CNN Health, the agency summarily suspended Grekos's license, stating that he had violated his restriction by administering stem cell treatments to another patient who had died.

The Regenocyte Web site, which has been online for more than five years, describes the company as "leading the world in regenerative cell therapy." The site also states that patients are evaluated at the Florida clinic and the treatment, which costs from $15,000 to $54,000, is administered at a hospital in the Dominican Republic. However, the Health Department says that in both cases related to the charges, Grekos performed the injections in his Bonita Springs office. Grekos has asked the Florida Court of Appeal to reinstate his license. [Freeman L. Attorney asks court to review Grekos case, reinstate medical license. naplesnews.com. April 30, 2012]


STATE OF FLORIDA
DEPARTMENT OF HEALTH

DEPARTMENT OF HEALTH,

Petitioner,

v.

ZANNOS G. GREKOS, M.D.,

Respondent.

_________________________________________________/


DOH CASE NO.: 2010-14317

AMENDED ADMINISTRATIVE COMPLAINT

Petitioner, Department of Health, by and through its undersigned counsel, files this Amended Administrative Complaint before the Board of Medicine against Respondent, Zannos G. Grekosl M.D., and in support thereof alleges:

1.  Petitioner is the state department charged with regulating the practice of medicine pursuant to Section 20,43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 458, Florida Statutes.

2.  At all times material to this order Respondent was board certified in Cardiovascular Disease and Internal Medicine.

3.  At all times material to this complaint. Respondent was a licensed physician within the State of Florida, having been issued license number ME 61912.

4.  At all times material to this Complaint Respondent's address of record was 9500 Bonita Beach Road, Suite 310, Bonita Springs, Florida 34153.

5.  The Department conducted an investigation of Respondent from September 3, 2010, through November 11, 2010.

6.  The investigation arose from the complaints from patient DF's husband (DF) and the Medical Examiner's Office.

7.  The investigation arose as a result of an experimental stem cell treatment Respondent performed on patient DF and her subsequent death.

8.  Patient DF was a 69 year-old female with a history of infiltrating ductal carcinoma of the breast which was first diagnosed in 2006; since then she had completed six cycles of chemotherapy and then radiation followed by Arimidex (an adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer).

9.  On February 17, 2010, patient DF consulted Respondent about stem cell treatment for her chemotherapy-induced peripheral neuropathy (damage to the peripheral nervous system including tingling, numbness, weakness and loss of sensation of the extremities) resulting from her cancer treatment.

10. Respondent's medical records show that on February 25, 2010, patient DF underwent carotid imaging with findings of approximately 0-29% bilateral stenosis (narrowing) of the carotid arteries.

11. On March 24, 20101 at the Regence Heart and Medical Center, Respondent performed a cerebral angiogram and then performed the experimental stem procedure when he injected unconcentrated autologous bone marrow aspirate into patient DF's cerebral circulation. Respondent then obtained selective cerebral angiograms after infusion of the bone marrow aspirate.

12. . Respondent performed this procedure on patient DF as an outpatient in the late afternoon of March 24, 2010;

13. Respondent did not attend patient DF post operatively and was not seen again till the following day in the North Collier Hospital emergency room.

14. Respondent failed to ensure that patient DF had recovered sufficiently post operatively to be safely discharged in light of the fact that at the point of being discharged from Regence Heart and Medical Center, patient DF appeared sedated and incoherent and was unable to walk.

15. Respondent failed to transfer patient DF to a hospital for continued post-operative care in light of the fact that at the point of discharge from Regence Heart and Medical Center patient DF appeared sedated, was incoherent and unable to walk.

16. Respondent abandoned patient DF post operatively to the care and attention of the two catheterization technicians who had assisted him in performing of the infusion of the unconcentrated autologous bone marrow aspirate into patient DF's cerebral circulation.

17. Neither catheterization technician was medically licensed in the State of Florida.

18. Despite the fact that post operatively, patient DF still appeared sedated, was incoherent and unable to walk, she was discharged home from the Regence Heart and Medical Center at approximately 6:15 p.m. by being physically carried from the Regence Heart and Medical Center to her car, this was accomplished with the assistance of patient DF's husband, DF, the receptionist, and the two catheterization technicians. subsequently, she was carried into her home from the car, by DF assisted by Respondent’s mother EG.

19. Patient DF remained Incoherent and unable to walk during the evening of March 24, 2010; she had also started to vomit profusely and uncontrollably; prompting DF to call Respondent on his mobile telephone.

20. Respondent failed to respond to three voice mail messages left by DF describing patient DF's worsening condition and his increasing concerns.

21. The paramedics were called and patient DF was then transported to the North Naples Hospital Emergency Room at approximately 2:00 a.m. on March 25, 2010, with altered mental status.

22. A CT scan of patient DF's head showed significant swelling in the brain with effacement of the fourth ventricle and possible stroke and hemorrhage. Patient DF was noted to have slurred speech, appeared very sleepy and was difficult to arouse.

23. Later in the morning of March 25, 2010, Respondent appeared at North Naples Hospital Emergency Room and made arrangements for patient DF to be admitted to Naples Community Hospital.

24. Patient DF was transported to Naples Community Hospital for neurosurgical intervention where a ventriculostomy to relieve some of the pressure on patient DF's brain was successfully performed.

25. Although Respondent admitted patient DF to Naples Community Hospital on March 25, 2010 he did not respond to any calls concerning patient DF and he did not return to attend to patient DF until March 28, 2010.

26. A further CT scan and MRls were done which confirmed the presence of a severe brain stem injury and infarct of the cerebellum. patient DF remained on mechanical ventilation until April 2, 2010, when life support and all therapeutic intervention other than palliative measures were withdrawn.

27. Patient DF's death on April 4, 2010, resulted from the infarcts of her left cerebella and left medulla.

28. Respondent's medical records. did not contain medical justification for the injection of unconcentrated autologous bone marrow aspirate into patient DF's cerebral circulation as a treatment for patient DF's neuropathy.

29. Respondent's treatment of patient DF's neuropathy by the injection of autologous bone marrow aspirate into the cerebellar circulation had no substantiated medical and/or scientific value.

COUNT ONE

30. Paragraphs 1 through 29 are adopted and realleged as though fully set forth.

31. Section  458.331(1)(t),  Florida Statutes (2010), provides that committing medical malpractice constitutes grounds for disciplinary action by the Board of Medicine. Medical malpractice is defined in Section 456.50(1)(g), Florida Statutes (2010), 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. For purposes of Section 458.331(1)(t), Florida Statutes (2010), the Board shall give great weight to the provisions of Section 766.102, Florida Statutes (2010), which provide that 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.

32. Respondent failed to practice medicine with that level of care, skill and treatment in violation of Section 458.331(1)(t), Florida Statutes (2010), which is recognized by a reasonably prudent Similar physician as being acceptable under similar conditions and circumstances in the treatment of patient DF in one or more of the following ways:

a.  By failing to show in the medical records the justification for injecting unconcentrated autologous bone marrow aspirate into patient DF's cerebral circulation for the treatment of patient DF's neuropathy;

b.  by performing a procedure that had no substantial medical and scientific value for the treatment of patient DF's peripheral neuropathy;

c.  by performing a procedure that had no proper medical foundation for success;

d.  by performing a procedure that was entirely experimental and not an accepted or proven treatment in the State of Florida;

e.  by performing a procedure that was dangerous and unwarranted; and by performing a procedure that was medically unnecessary and very dangerous;

f.  by performing a procedure that placed the patient at an inordinate risk of death and/or serious injury.

g.  by failing to provide or provide for adequate post operative care to patient DF in the afternoon of March 23, 2010;

h.  by failing post operatively to admit OF to Naples Community Hospital in the afternoon of March 23, 2010;

i.  by performing a cerebral angiogram at his Bonita Beach Road medical practice instead of at a hospital, where a neurosurgeon would have been on call;

j.  by abandoning and not providing care to patient DF for 3 days after admitting her to Naples Community Hospital. 33. Based on the foregoing, Respondent has violated Section 458.331(1)(t), Florida Statutes (2010).

COUNT TWO

34. Paragraphs 1 through 29 are adopted and realleged as though fully set forth.

35.  Section 458.331(1)(m), Florida Statutes (2010), subjects a licensee to discipline for failing to keep legible, as defined by department rule in consultation with the board, medical records that identify the licensed physician or the physician extender and supervising physician 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.

36. On or about March 24, 2010, Respondent violated Section 458.331(1)(m), Florida Statutes (2010), by failing to keep medical records that justified patient DF's course of treatment.

37. Based on the foregoing, Respondent has violated Section 458.331(1)(m), Florida Statutes (2010).

COUNT THREE

38. Paragraphs 1 through 29 are adopted and realleged as though fully set forth.

39. Section 458.331(1)(n), Florida Statutes (2010), subjects a licensee to discipline for exercising influence on the patient or client in such a manner as to exploit the patient or client for financial gain of the licensee or of a third party, which shall include, but not be limited to, the promoting or selling of services, goods, appliances, or drugs.

40. On or about March 24, 2010, Respondent violated Section 458.331(1)(n), Florida Statutes (2010), by exercising influence on the patient or client in such a manner as to exploit the patient or client for financial gain when he induced patient DF to submit to this procedure.

41. Based on the foregoing, Respondent has violated Section 458.331(1)(n)1 Florida Statutes (2010).

COUNT FOUR

42. Paragraphs 1 through 29 are adopted and realleged as though fully set forth.

43. Section 458.331(1)(p), Florida Statutes (2010), subjects a licensee to discipline for performing professional services which have not been duly authorized by the patient or client.

44. Informed consent requires that a physician sufficiently educate a patient as to the risks, benefits, and alternatives to a proposed treatment to allow a patient to consider the information prior to signing an "informed consent" form.

45. Prior to injecting unconcentrated autologous bone marrow aspirate into patient DF's cerebral circulation for the treatment of patient DF's peripheral neuropathy, Respondent failed to adequately explain to patient DF:

a.  That the injection of a matrix of unconcentrated bone marrow material directly into the carotid artery of the patient has no substantiated medical and scientific value to treat the patient's peripheral neuropathy;

b.  that the use of unorthodox stem cell transfusions for diseases that have shown no benefit can be extremely dangerous;

c.  that the treatment provided to the patient had no proper medical foundation for success; and/or

d.  that this procedure was entirely experimental and certainly not an accepted or proven treatment in the state of Florida.

47.  By failing to make this disclosure and explain the consequences of injecting unconcentrated autologous bone marrow aspirate into patient DF's cerebral Circulation, Respondent failed to obtain patient DF's knowing and informed consent to the injecting of unconcentrated autologous bone marrow aspirate into patient DF's cerebral circulation for the treatment of her peripheral neuropathy.

48.  Based on the foregoing Respondent violated Section 458.331(1)(p) Florida Statutes (2010).

COUNT FIVE

46. Petitioner realleges and incorporates paragraphs 1 through 29 as if fully set forth herein.

47. Section 456.072(1)(bb), Florida Statutes (2010), 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 unrelated to the patient's diagnosis or medical condition is grounds for disciplinary action by the Board of Medicine.

48. Respondent performed a wrong procedure, or an unauthorized procedure or a procedure that was medically, unnecessary or otherwise unrelated to the patient's diagnosis or medical condition by injecting unconcentrated autologous bone marrow aspirate into patient DF's cerebral circulation for the treatment of patient DF's peripheral neuropathy when patient DF's diagnosis or medical condition did not warrant such procedure.

49. Based on the foregoing, Respondent has violated Section 456.072(1)(bb), Florida Statutes (2010), by performing a procedure that was medically unnecessary or otherwise unrelated to Patient DF's diagnosis or medical condition.

WHEREFORE, the Petitioner respectfully requests that the Board of 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 25TH day of April, 2012.

STEVEN L. HARRIS, M.D., M.Sc.
Interim State Surgeon General
Florida Department of Health

NICHOLAS W. ROMANELLO
General Counsel
Florida Department of Health

VERONICA E. DONNELLY
Attorney Supervisor
Prosecution Services Unit

Robert A. Milne
Assistant General Counsel
Florida Bar # 622338

Ian Brown
Assistant general Counsel
Florida Bar # 499048
DOH Prosecution Services Unit
4052 Bald Cypress Way-Bin C-65
Tallahassee, Florida 32399-3265
(850) 245-4640 Office
(850) 245-4681 Facsimile

NOTICE OF RIGHTS

Respondent has the right to request a hearing to be conducted in accordance with Section 120.569 and 120.57, Florida Statutes, to be represented by counselor 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 456.072(4), 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 to any other discipline imposed.

This page was posted on May 21, 2012.

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