Disciplinary Action against
Steven J. Harris, M.D.
Stephen Barrett, M.D.
In 2013, the Medical Board of California charged Steven J. Harris, M.D, with gross negligence, repeated negligent acts, and incompetence in connection with his management of three patients that he had diagnosed with Lyme disease. The accusation (shown below) stated that Harris prescribed unnecessary courses of treatment with antibiotics and various other products. Ross operates Pacific Frontier Medical, Inc. in Redwood City, California. His clinic Web suites states that since 2001, he has focused his practice on the diagnosis and treatment of Lyme disease and other tick-borne co-infections and that "approach to Lyme disease he incorporates strategies found in conventional, functional and complimentary medicine." The case was settled with a stipulated settlement under which Harris was reprimanded and required to take 40 hours of approved continuing education aimed at "areas of deficient practice as identified in the Accusation and shall include, but not be limited to, evidence-based treatment techniques for Holistic/Integrative Medicine as offered by the Scripps Holistic/Integrative Medicine Program, or an equivalent, as well as courses pertaining to informed consent." In 2014, in response to the California actiion, the Illinois Department of Financial and Professional Regulation placed Harris's license into "refuse to renew" status.
MEDICAL BOARD OF CALIFORNIA
DEPARTMENT OF CONSUMER AFFAIRS
STATE OF CALIFORNIA
In the Matter of the First Amended Accusation Against:
STEVEN JEFFREY HARRIS, M.D.
Physician's and Surgeon's Certificate
Case No. 03-2011-215765
FIRST AMENDED ACCUSATION
1. Kimberly Kirchmeyer (Complainant) brings this First Amended Accusation solely in her official capacity as the Interim Executive Director of the Medical Board of California, Department of Consumer Affairs.
2. On or about June 22, 2000, the Medical Board of California issued Physician's and Surgeon's Certificate Number A 72195 to Steven Jeffrey Harris, M.D. (Respondent). The Physician's and Surgeon's Certificate was in full force and effect at all times relevant to the charges brought herein and will expire on May 31, 2014, unless renewed.
3. This Accusation is brought before the Medical Board of California (Board)1 under the authority of the following laws. All section references are to the Business and Professions Code unless otherwise indicated.
1The term "Board" means the Medical Board of California; "Division of Medical Quality" shall also be deemed to refer to the Board.
4. Section 2004 of the Code states in relevant part:
"The board shall have the responsibility for the following:
"(a) The enforcement of the disciplinary and criminal provisions of the Medical Practice Act.
"(b) The administration and hearing of disciplinary actions.
"(c) Carrying out disciplinary actions appropriate to findings made by a panel or an administrative law judge.
"(d) Suspending, revoking, or otherwise limiting certificates after the conclusion of disciplinary actions.
"(e) Reviewing the quality of medical practice carried out by physician and surgeon certificate holders under the jurisdiction of the board."
5. Section 2227 of the Code provides that a licensee who is found guilty under the Medical Practice Act may have his or her license revoked, suspended for a period not to exceed one year, placed on probation and required to pay the costs of probation monitoring, or such other action taken in relation to discipline as the Division deems proper.
6. Section 2234 of the Code states in pertinent part:
"The board shall take action against any licensee who is charged with unprofessional conduct. In addition to other provisions of this article, unprofessional conduct includes, but is not limited to, the following:
"(a) Violating or attempting to violate, directly or indirectly, assisting in or abetting the violation of, or conspiring to violate any provision of this chapter.
"(b) Gross negligence.
"(c) Repeated negligent acts. To be repeated, there must be two or more negligent acts or omissions. An initial negligent act or omission followed by a separate and distinct departure from the applicable standard of care shall constitute repeated negligent acts.
"(1) An initial negligent diagnosis followed by an act or omission medically appropriate for that negligent diagnosis of the patient shall constitute a single negligent act.
"(2) When the standard of care requires a change in the diagnosis, act, or omission that constitutes the negligent act described in paragraph (1), including, but not limited to, a reevaluation of the diagnosis or a change in treatment, and the licensee's conduct departs from the applicable standard of care, each departure constitutes a separate and distinct breach of the standard of care.
7. Section 2234.1 of the Code provides in pertinent part:
"(a) A physician and surgeon shall not be subject to discipline pursuant to subdivision (b), (c), or (d) of Section 2234 solely on the basis that the treatment or advice he or she rendered to a patient is alternative or complementary medicine, including the treatment of persistent Lyme disease, if that treatment or advice meets all of the following requirements:
"(1) It is provided after informed consent and a good-faith prior examination of the patient, and medical indication exists for the treatment or advice, or it is provided for health 01 well-being.
"(2) It is provided after the physician and surgeon has given the patient information concerning conventional treatment and describing the education, experience, and credentials of the physician and surgeon related to the alternative or complementary medicine that he or she practices.
"(3) In the case of alternative or complementary medicine, it does not cause a delay in, or discourage traditional diagnosis of, a condition of the patient.
"(4) It does not cause death or serious bodily injury to the patient."
8. Section 2078 of the Code provides in pertinent part:
"(a) As used in this section "DMSO" means dimethyl sulfoxide.
"(b) A licensed physician and surgeon shall, prior to treating a patient with a DMSO preparation, inform the patient in writing if DMSO has not been approved as a treatment or cure by the Food and Drug Administration for the disorder for which it is being prescribed.
"(c) If DMSO is prescribed for any purpose other than for those purposes approved pursuant to Section 111550 of the Health and Safety Code, informed consent shall first be obtained from the patient. As used in this subdivision, "informed consent" means the authorization given by the patient for treatment with DMSO after each of the following conditions have been satisfied:
"(l) The patient is informed verbally, in nontechnical terms, about all of the following:
"(A) A description of treatment procedures to be used in administering DMSO. "(B) A description of any attendant discomfort and risks to the patient that can be reasonably expected from treatment with DMSO.
"(C) An explanation of any benefits to the patient that can be reasonably expected. "(D) An explanation of any appropriate alternative procedures, drugs, or devices that might be advantageous to the patient, and their relative risks and benefits.
"(E) An offer to answer any inquiries concerning the treatment of the procedures involved.
"(2) The patient signs and dates a written consent form acknowledging that disclosure has been given pursuant to paragraph (1), and acknowledging consent to treatment with DMSO pursuant to this section. The patient shall be provided with a copy of the signed and dated form."
FIRST CAUSE FOR DISCIPLINE
(Gross Negligence/Repeated Negligent Acts/Incompetence re Patient A.P.)
9. Respondent is subject to disciplinary action for unprofessional conduct under Code section 2234, including subsections (b) and/or (c) and/or (d), in that Respondent was grossly negligent and/or repeatedly negligent and/or incompetent in his care and treatment of Patient A.P. The circumstances are as follows:
10. Respondent operates Pacific Frontier Medical, Inc. in Redwood City, California. He is board-certified in Family Medicine. According to Respondent's website, his practice focuses on diagnosing and treating Lyme disease and other tick-borne co-infections.
11. On or about January 14, 2009, A.P., a then 26-year old female patient, was seen at Respondent's office for evaluation of possible Lyme disease. An initial history and examination was conducted by Y.L., a physician assistant. A.P. reported a tick bite in December 2008 as well as prior tick bites in 2005 or 2006. She did not recall developing any rash or lesions. She reported numerous complaints, including memory problems, fevers, headaches, mood swings, poor sleep, muscle and joint pain, slurred speech, and numbness and tingling in her extremities and face. She reported having been diagnosed with attention deficit disorder as a child. She reported seeing a psychiatrist for depression and questionable borderline personality. She was taking Adderall and Ambien. Y.L. did not find any significant abnormalities on physical examination. Y.L.'s assessment was "multisystemic complaints with recent tick bite." Zithromax, an antibiotic, was prescribed and laboratory tests were ordered. There is no evidence that Respondent examined A.P. during this initial visit; however, Respondent initialed the patient's chart.
12. A.P. returned to Respondent's office on or about February 3, 2009, to review laboratory results. Immunoglobulin M (IgM) and Immunoglobulin G (IgG) Western Blots were negative for Lyme disease under the Center for Disease Control (CDC) criteria. Additionally, laboratory results were negative for Babesia; negative for Bartonella; negative for Human Menocytic Ehrlichiosis (HME); and Lyme Polymerase Chain Reaction (PCR) was negative. However, Y.L. noted that lgM Western Blot was positive (apparently under a lower criteria) and that Human Granulocytic Ehrlichiosis (HGE) was positive. Her assessment was "lyme," "HGE," and "possible co-infections despite neg tests." A.P. was continued on Zithromax, and was also prescribed Doxycycline, another antibiotic. She was also started on BLT (Bartonella-Lyme Tincture) and Enula—both herbal remedies. Respondent initialed the patient's chart.
13. A.P. was next seen by Y.L. for a follow-up examination on March 9, 2009. A.P. continued to have multiple complaints, but no significant objective findings were noted. No vital signs were recorded. A.P. was continued on Zithromax, discontinued on Doxycycline, prescribed Bicillin, another antibiotic, and prescribed Plaquenil and Malarone, both anti-malaria drugs. A.P. was continued on BLT, and started on a "stress buster kit," "detox and drainage" kit, and "pinella" - all homeopathic and/or herbal remedies. Respondent initialed the patient's chart.
14. A.P. was next seen by Y.L. on April 6, 2009. Examination revealed "slight inflammation of cuticles on forefingers." No vital signs were recorded. A.P.'s dosage of Bicillin was increased and she was continued on Malarone, Zithromax, and Plaquenil. Alinia, an antiprotozoal drug, and Singulair, a drug used to treat asthma, were also added to her treatment regimen. Respondent initialed the patient's chart.
15. A.P. was next seen by Y.L. on May 11, 2009. No vital signs were recorded. A.P. was continued on Bicillin, Zithromax, Plaquenil, and Alinia. Mepron, another antiprozoal drug, was added. Respondent was also started on "200 mg of zen." Respondent initialed the patient's chart.
16. On June 10, 2009, A.P. was seen by Respondent. Respondent noted that A.P. was "doing poorly with significant fatigue, malaise, weakness, headaches, irritability, and tremors." No vital signs were recorded. Respondent's assessment was "Neurologic Lyme and likely Babesia." Respondent's treatment plan included: "continue Bicillin for now;" "use Cat cream and fish oil," "stop Plaquenil," "follow-up with Dr. Felch" (a chiropractor); "obtain thyroid, PTH [parathyorid hormone], vitamin D, and neurotransmitters," and "consider colon hydrotherapy and vitamin D as well as Adrena Calm cream."
17. A.P. continued to see Respondent and/or Y.L. on approximately a monthly basis through at least March 2011. A.P.'s vital signs were not recorded during these visits. Respondent's last office visit notes for A.P., dated March 30, 2011, show an assessment of Lyme, Bartonella, and Babesia. During this time, Respondent prescribed numerous additional medications, supplements, and herbal remedies, including intravenous (IV) Rocephin, IV Glutathione, L-Drain, K-Drain, UltralnflamX, Biaxin, Minocycline, Darvocet, Chlorella, enzymes, HCL betaine, Actigall, Bactroban, Burbur,; Notatum/Quentens nasal spray; Bronchi Pertu; Lyrica, Trental, IV amino acids; Zenpep; IV Zithromax; IV Invanz; bee venom injections; IV Doxycycline; IV Silver; Cortef; Nuvigil; IV Ketamine; Tindamax; Cipro, Amoxicillin; Artemisinin; Ketek, and IV garlic.
18. At Respondent's recommendation, A.P. also consulted with and received treatment from Dr. C.R., a naturopath.
19. There is no evidence that Respondent received informed consent from A.P. regarding treatment with IV glutathione, IV amino acids, IV silver, or IV garlic.
20. On or about May 3, 2011, A.P. developed acute and severe symptoms, including abdominal pain, nausea and vomiting, after self-administering IV garlic received from Respondent's office. On May 4, 2011, A.P.'s parents took her to the Good Samaritan emergency room where she was admitted to ICU. She was found to be hypotensive secondary to bacterial sepsis. She was diagnosed as having catheter-related polymicrobial septicemia; candida fungemia; mild renal impairment; mild hepatitis; cavitary lesions/microabcesses; and herpetic cold sores. She was hospitalized for 8 days, and discharged on May 11, 2011.
21. Respondent's overall conduct, acts and/or omissions with regard to patient A.P. constitutes unprofessional conduct through gross negligence and/or repeated acts of negligence and/or incompetence. More specifically, Respondent is guilty of unprofessional conduct with regard to A.P. as follows:
A. Respondent subjected A.P. to unnecessary and unconventional therapeutic regime, including IV garlic, which resulted in serious harm.
B. Respondent prescribed IV Ketamine without medical indication.
C. Respondent did not obtain informed consent regarding treatment with IV glutathione, IV amino acids, or IV garlic.
D. Respondent failed to routinely assess and/or document A.P.'s vital signs.
SECOND CAUSE FOR DISCIPLINE
(Gross Negligence/Repeated Negligent Acts/Incompetence re Patient T.L.)
22. Respondent is subject to disciplinary action for unprofessional conduct under Code section 2234, including subsections (b) and/or (c) and/or (d), in that Respondent was grossly negligent and/or repeatedly negligent and/or incompetent in his care and treatment of Patient T.L. The circumstances are as follows:
23. On or about March 25, 2010, T.L., a then 54-year old male patient, was seen at Respondent's office for evaluation of Lyme disease. T.L. did not recall having a tick bite or developing any rash or lesions. T.L. reported numerous complaints, including fatigue, flu-like symptoms, loss of appetite, hair loss, sore throat, sore glands, night sweats, chills, chest pain tightness, musculoskeletal pain and swelling, anxiety attacks, decreased concentration, headaches, memory problems, mood swing, nightmares, panic attacks, poor balance and difficulty walking, seizures, difficulty sleeping, tremors, and weakness of limbs, abdominal pain, constipation, nausea, vomiting, and weight loss. T.L. reported that he had never been diagnosed with Lyme disease.
24. Laboratory tests conducted in April 2010 were negative for Lyme disease.
25. Respondent's notes dated May 11, 2010 also state that laboratory tests were negative for Lyme disease, and Respondent's assessment was "myalgias with hyperesthes." Despite the negative laboratory results, Respondent noted that "Bartonella/Lyme is still a possibility," and T.L. was started on the "Cowden protocol," a homeopathic protocol for treating Lyme disease, and also started on "BSP 201," a supplement.
26. On or about June 10, 2010, Respondent prescribed Doxycycline, an antibiotic.
27. On or about September 13, 2010, T.L. was examined by physician assistant Y.L., who noted that T.L was doing poorly overall. Y.L.'s assessment was "probably lyme." No vital signs were recorded.
28. T.L. continued to complain of worsening symptoms and saw Respondent and/or Y.L. on approximately a bi-monthly basis through at least March 2012. T.L.'s vital signs were not recorded during these visits.
29. Respondent's notes dated November 2, 2010 state that T.L. has "remarkable pain, fatigue, weakness, malaise, and significant reactivity. He is unable to control the pain with the current regimen." Respondent's assessment was "Lyme with severe full body symptoms, quite ill." Respondent's plan included starting "ketamine IV," "obtain a KPU and copper," "Continue the current regimen with Dr. R," and "Consider remediating the house for mold."
30. Respondent's notes dated February 2, 2011 state that T.L. had complaints of "profound fatigue and weakness" and that "Overall, the patient continues to do poorly." Respondent also noted that T.L. was "still addressing mold and would like to begin a more aggressive treatment for Lyme." Respondent's assessment was "Lyme," "Mold," and "Neurologic decline." Respondent's treatment plan included: "consider ketamine;" "consider a port;" "recommend IV Garlic."
31. Progress notes from February 28, 2011 indicate that T.L. was seen by Y.L., who noted that "patient continues to do poorly. Profound fatigue and weakness." IV Garlic was started. In addition, oral Septra, an antibiotic, was started, and T.L. was continued on Sporanox and Nystatin—both antifungal drugs. He was also continued on Lymphomosot and Itires—both homeopathic remedies.
32. A list of T.L. medications from February 2011 indicates that he was being treated with over 50 medications, supplements and herbal/homoeopathic remedies.
33. Respondent's notes dated April 14, 2011 state that T.L. had "severe tendinosis and full body pain." Respondent noted that Dr. R's priorities were "Borrelia and heavy metals." T.L. reported feeling much worse for several days after IV Garlic treatment. T.L. reported having to increase his pain medications, having severe nausea and severe weakness, and needing to walk with a cane. Respondent's treatment plan was to "ramp up Rocephin," "start Actigall," "decrease Garlic," and "use ketamine intranasal every few hours."
34. On or about May 5, 2011, T.L. was admitted to Good Samaritan Hospital with complaints of fever, chills and adnominal pain. T.L. reported having received IV garlic and IV DMSO (Dimethyl sulfoxide) infusions through a Mediport. T.L. was diagnosed as having Klebsiella oxytoca bacteremia and Gallbladder dyskinesia. T.L.'s Medi port was removed, and he was discharged on May 9, 2011, with the advisement not to take any IV materials and substances that are not FDA approved and manufactured under strict FDA regulations to ensure standards of care.
35. Following his discharge from the Good Samaritan Hospital, T.L. continued to receive treatment under Respondent's care, including treatment with IV Levaquin, IM lnvanz, Takuna, Transfer Factor, increased dosage of Nystatin, Yeast Ease, Olive Leaf Extract Secure; Enhansa Lee Silsby Pharmacy, Aloe 225, Magnesium Malate, vitamin C, GI revive, Aloe vera juice, Chamomile Tea, DGL, Cromolyn sodium, Reglan, Cryptolepis, and Malarone. Respondent also noted that "removing metals from mouth" should be considered.
36. T.L.'s medication list dated November 28, 2011, identifies over 15 prescribed medications (including IV glutathione and IV Ketamine), 4 herbal/homeopathic remedies, and 29 supplements.
37. There is no evidence that Respondent obtained informed consent to treat T.L. with IV garlic, IV glutathione, IV DMSO, or IV Ketamine.
38. Respondent's overall conduct, acts and/or omissions with regard to patient T.L. constitutes unprofessional conduct through gross negligence and/or repeated acts of negligence and/or incompetence. More specifically, Respondent is guilty of unprofessional conduct with regard to T.L. as follows:
A. Respondent continued to prescribe multiple courses of antibiotics (IV, oral and intramuscular) for over a year even though there were no signs of improvement. Prolonged courses of antibiotics can result in adverse reactions and select resistance to the common bacterial infections he could acquire later on in life.
B. Respondent prescribed IV Ketamine without medical indication.
C. Respondent subjected T.L. to other unnecessary therapeutic regime, including IV garlic, which resulted in serious harm.
D. Respondent failed to obtain informed consent regarding treatment with IV garlic, IV glutathione, IV DMSO, or IV Ketamine.
E. Respondent failed to review his treatment plan for T.L., including failing to repeat laboratory tests to confirm whether T.L. had Lyme Disease.
F. Respondent failed to routinely assess and/or document T.L.'s vital signs.
THIRD CAUSE FOR DISCIPLINE
(Treating with DMSO without Informed Consent)
39. Respondent is subject to disciplinary action for unprofessional conduct under Code section 2234(a) in that Respondent treated T.L. with DMSO without obtaining informed consent, in violation of Code section 2078.
FOURTH CAUSE FOR DISCIPLINE
(Gross Negligence/Repeated Negligent Acts/Incompetence re Patient L.H.)
40. Respondent is subject to disciplinary action for unprofessional conduct under Code section 2234, including subsections (b) and/or (c) and/or (d), in that Respondent was grossly negligent and/or repeatedly negligent and/or incompetent in his care and treatment of Patient L.H. The circumstances are as follows:
41. Respondent's medical records indicate that he began treating L.H. in 2006, when L.H. was 13-years of age. In February 2006, L.H.'s mother filled out a Lyme Disease Questionnaire in which she stated that L.H. had tested positive for Babesia and Bartonella in November 2005. Respondent's medical records do not include any positive laboratory results for Babesia or Bartone Ila.
42. Respondent's notes from January 17, 2007 show an assessment of Lyme and Bartonella. However, there is no evidence that Respondent conducted any laboratory tests prior to making such diagnoses. IgG and IgM Western Blots, conducted on May 31, 2007, were both negative for Lyme disease. Subsequent IgG and IgM Western blots conducted in January 2008, February 2009, and July 2010 were again all negative for Lyme disease. A Bartonella FISH test, conducted in October 2010, was also negative.
43. L.H. continued to see Respondent on approximately a monthly basis through at least March 2012. During this time, Respondent prescribed numerous IV and oral antibiotics, in various combinations, including IV Doxycycline, IV Invanz, IV Rocephin, IV Zithromax, IV Cefuroxime, Rifampin, Minocycline, A velox, Septra, Moxatag, Nystatin, Tindamax, Penicillin, and Zyvox. L.H. was also treated with numerous homeopathic remedies, including IV glutathione, IV Freamine, and numerous supplements, anti-microbials, and detoxification remedies.
44. There is no evidence that Respondent obtained informed consent to treat L.H. with IV glutathione or IV Freamine.
45. On or about February 9, 2012, L.H. was admitted to El Camino Hospital with fevers and chills. She was diagnosed as having sepsis due to a Hickman catheter infection, which had been in place for 4. 5 years. According to the emergency room physician, L. H.' s mother presented a medication list that identified over 70 medications and homeopathic remedies, including IV Cefuroxime, IV glutathione, and IV Freamine, as well as oral Penicillin and Zyvox. The Hickman catheter was removed, and L.H. was discharged from El Camino Hospital on February 12, 2012.
46. Respondent's overall conduct, acts and/or omissions, with regard to patient L.H., constitutes unprofessional conduct through gross negligence and/or repeated acts of negligence and/or incompetence. More specifically, Respondent is guilty of unprofessional conduct with regard to L.H. as follows:
A. Respondent continued to prescribe multiple courses of antibiotics (IV and oral) for over a five-year period even though there were little, if any, signs of improvement. Prolonged courses of antibiotics can result in adverse reactions and select resistance to the common bacterial infections she could acquire later on in life.
B. Respondent failed to obtain informed consent regarding treatment with IV glutathione and IV Freamine.
C. Respondent failed to routinely assess and/or document L.H.'s vital signs.
FIFTH CAUSE FOR DISCIPLINE
(Repeated Negligent Acts)
47. Respondent is subject to disciplinary action for unprofessional conduct under Code section 2234(c) for repeated negligent acts with regard to his acts and/or omissions as alleged in paragraphs 9 through 46 which are incorporated herein by reference as if fully set forth.
WHEREFORE, Complainant requests that a hearing be held on the matters herein alleged, and that following the hearing, the Medical Board of California issue a decision:
1. Revoking or suspending Physician's and Surgeon's Certificate Number A 72195, issued to Steven Jeffrey Harris, M.D.;
2. Revoking, suspending or denying approval of Steven Jeffrey Harris, M.D.'s authority to supervise physician assistants, pursuant to section 3527 of the Code;
3. Ordering Steven Jeffrey Harris, M.D., if placed on probation, to pay the Medical Board of California the costs of probation monitoring; and
4. Taking such other and further action as deemed necessary and proper.
August 27, 2013
Interim Executive Director
Medical Board of California
Consumer Affairs State of California
This article was posted on October 30, 2018.