Geoffrey S. Ames
In 2004, the Washington Department of Health Medical Quality Assurance Commission concluded that Geoffrey S. Ames, M.D., who practices in Richland, Washington, had committed unprofessional conduct by using a LISTEN device to (incorrectly) diagnose a patient as having an "egg allergy." Such devices which provide readings based on the patient's skin resistance to a tiny electric current, are not FDA-approved for diagnosis and have no diagnostic value. The Commission issued a 5-year license suspension that would be stayed provided that Ames (a) stopped using the device, (b) undergoes quarterly practice reviews, and (c) pays a $5,000 fine. In 2007, the [appeal.shtml Washington Court of Appeals] upheld the Health Department's decision, ruling that use of the device had created an "unreasonable risk of harm." In 2009, the [/board/med/ames/supreme_court.pdf Washington Supreme Court agreed], stating that Ames had "led patients to believe that LISTEN could diagnose and treat allergies, when in fact it could do neither."
STATE OF WASHINGTON DEPARTMENT OF HEALTH
MEDICAL QUALITY ASSURANCE COMMISSION
In the Matter of the License to Practice
FINDINGS OF FACT,
Respondent, Geoffrey S. Ames, M.D.
William Bishin, Attorney at Law
Department of Health, by
The Office of Attorney General, per
Keith D. Armstrong, Assistant Attorney General
Cabell Tennis, J.D., Public Member, Panel Chair
Jan Paxton, PA-C, Pro Tem
Sunanda Uberoi, M.D.
PRESIDING OFFICER: Arthur E. DeBusschere, Health Law Judge
The Medical Quality Assurance Commission (the Commission) convened a hearing on January 13-16, 2004 and February 10, 2004. The Department's post-hearing brief was submitted to the Commission on February 25, 2004. The Commission deliberated on March 10, 2004.
The Department of Health issued First Amended Statement of Charges alleging that the Respondent had violated the Uniform Disciplinary Act. License Suspended. Stayed.
Whether the Respondent engaged in unprofessional conduct within the meaning of RCW 18.130.180(1), (4), (7) and (16).
If the Department proves unprofessional conduct, what are the appropriate 'sanctions under RCW 18.130.160?
SUMMARY OF EVIDENCE
In consideration of this matter, the Commission heard over thirty-three hours of testimony and oral argument. The Department presented testimony of the following witnesses: Geoffrey Ames, M.D. (the Respondent); Patient One; Richard Sherman, Ph.D.; and Neil Odgen. The Respondent testified on his behalf and presented testimony of the following witnesses: Donald Volkman; Joan McVey; James Clark; and David Martin, M.D. The Department's had two exhibits admitted, which were numbered as Department's Exhibit No. 2 and Department's Exhibit No. 3. The Respondent had eight exhibits admitted, Respondent's Exhibits Nos. 1-8.
The Uniform Disciplinary Act (the UDA) defines what conduct, acts, or conditions constitute unprofessional conduct. RCW 18.130.180. In this case, the Department alleged that the Respondent committed four violations under the UDA, specifically RCW 18.130.180(1), (4), (7) and (16).
First, the Department alleged the Respondent's conduct was unprofessional under RCW 18.130.180(1), unprofessional conduct is defined in part as:
The commission of any act involving moral turpitude, dishonesty, or corruption relating to the practice of the person's profession, whether the act constitutes a crime or not.
RCW 18.130.180(1). During the hearing, the Commission granted the Respondent's motion to dismiss the alleged violation under RCW 18.130.180(1).
Second, the Department alleged the Respondent's conduct was unprofessional under RCW 18.130.180(4), which is defined as:
Incompetence, negligence, or malpractice which results in injury to a patient or which creates an unreasonable risk that a patient may be harmed. The use of a nontraditional treatment by itself shall not constitute unprofessional conduct, provided that it does not result in injury to a patient or create an unreasonable risk that a patient may be harmed;
Expert testimony is helpful, but not essential to the Department's case, nor would the lack of such testimony either support or require dismissal of the charges against Respondent. Johnston v. Washington State Medical Disciplinary Board, 99 Wn.2d 466, 663 P.2d 457 (1983); Brown v. State Department of Health, Dental Disciplinary Board, 94 Wn. App. 7, 972 P.2d 101 (1998). Based on the Johnston and Brown cases, the Commission can use its own expertise to evaluate the standard of care regarding the Respondent's actions with Patient One. No additional expert is necessary to resolve this case. RCW 34.05.461(5).
Third, the Department alleged the Respondent's conduct was unprofessional under RCW 18.130.180(7), which is defined as:
Violation of any state or federal statute or administrative rule regulating the profession in question, including any statute or rule defining or establishing standards of patient care or professional conduct or practice;
RCW 18.130.180(7). Specifically, the Department charged the Respondent for violating a federal code, 21 U.S.C. § 331 (c), which provides as follows:
Sec. 331. - Prohibited acts
The following acts and the causing thereof are hereby prohibited:
. . . .
(c) The receipt in intrastate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.
The Department also charged the Respondent for violating a state statute, RCW 69.04.040(1) and (3), which provides as follows:
The following acts and the causing thereof are hereby prohibited:
(1) The sale in intrastate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded.
. . . .
(3) The receipt in intrastate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the sale thereof in such commerce for pay or otherwise.
This statute is similar to the above federal code, 21 U.S.C. § 331(c). The facts that would apply to the federal code would apply as well to the allegations under RCW 69.04.040, regarding the LISTEN device being adulterated or misbranded.
In this case, Mr. Ogden did not know about the LISTEN device that was purchased by the Respondent. Likewise, Dr. Sherman not only did not know about the LISTEN device, but also had not seen or evaluated it. In addition, there was no evidence that the manufacturer or the Respondent made significant changes to the LISTEN device that it thereby became adulterated. There was no evidence that the Respondent mislabeled the LISTEN device; thus, there was no evidence that it was misbranded. Finally, the Department failed to offer evidence that the Respondent delivered or offered it for delivery to someone else for pay. During the hearing, the Commission granted the Respondent's motion to dismiss the allegation of unprofessional conduct under RCW 18.130.180(7)
Fourth, the Department alleged the Respondent's conduct was unprofessional under RCW 18.130.180(16), which is defined as:
Promotion for personal gain of any unnecessary or inefficacious drug, device, treatment, procedure, or service;
During the hearing, the Commission heard and observed the testimony of Patient One and the Respondent. The Commission finds Patient One credible when he testified about his visits with and treatment by the Respondent on June 6, 2001 and July 11, 2001. The Commission did not find the Respondent credible when he testified about his treatment of Patient One on these dates. RCW 34.05.461.
I. FINDINGS OF FACT
1.1 Geoffrey S. Ames, M.D., the Respondent, was issued by the state of Washington in December 1989, a license to practice as a physician and surgeon. The Respondent completed a pathology residency. He completed a year of internal medicine training. He started a family practice in Gardnerville, Nevada. The Respondent is board-certified in holistic medicine. The Respondent took an acupuncture course at UCLA, San Francisco. Since 1995, he has been practicing as a physician in Richland, Washington. The Respondent's practice includes the following specialties: NAET1 allergy therapy, JMT allergy therapy, neuromodulation technique allergy therapy, acupuncture, acupressure and dermatology.
1NAET stands for Nambudripad Allergy Elimination Technique. Devi S. Nambudripad developed the NAET, which is a technique that treats allergies using acupressure.
1.2 The Life Information System Tens device (the LISTEN device) is a galvanic skin response machine. The LISTEN device consists of a keyboard, monitor, a computer with hardware, foot mouse, black box used to create the circuit so an ohmmeter will work. The black box has a wire to a metal probe that is held by the patient in his/her hand. The LISTEN device is an electronic skin response device and it measures changes in resistance, which is the impediment of a flow of electrical current. The LISTEN device uses low voltage, a current of five ohms, to measure galvanic skin resistance.
1.3 James Clark developed the LISTEN device. On January 7, 1992, he submitted information on a LISTEN device to the United States Food and Drug Administration (FDA). The LISTEN system was described as having electrodermal screening techniques, alternative medicine techniques and bioenergetic techniques. The device was not cleared with that labeling. It did not receive pre-market approval since it was not substantially equivalent to predicate devices studied by the FDA.
1.4 In August 1992, James Clark made a submission for the Digital Conductance Meter (DCM) to clear the ohmmeter and the capability for the Listen System without the acupuncture claims and to market the LISTEN device. The FDA cleared the DCM as a biofeedback device for relaxation training. The DCM had been submitted for other uses, but those were removed from the FDA file.
1.5 James Clark has a number of upgraded models that are galvanic skin response devices. They are called the Orion, the Pegasus and the Mira. These upgraded devices have the same hardware as the LISTEN device; they both have the ohmmeter, computer software and the signal generator. The only difference between the LISTEN device and the later devices was that the LISTEN device was a DOS-operated system while these upgraded devices were a WINDOWS based system.
1.6 In 1996, James Clark obtained clearance from the FDA for the Orion, the Pegasus and the Mira. In 1996, the FDA notified him that his devices (the Orion, the Pegasus and the Mira) were substantially equivalent to a predicate device, which permitted him to proceed to market the devices. James Clark received a pre-market "clearance," not a pre-market "approval." Nevertheless, he could not market the devices as being cleared, because the public might think that the FDA had approved them.
1.7 The Respondent does not know the physics behind the LISTEN device, nor did he know the voltage or amperage that the LISTEN device produces. The Respondent understands the LISTEN device functions like a biofeedback machine, but it is used in different ways. He used it in combination with kinesiology. Kinesiology is based on the theory that an imbalance in acupuncture meridians will make muscles weak. The Respondent learned kinesiology from a NAET course.
1.8 The Respondent heard about the LISTEN device from colleagues, from vendors and from attending conferences of the American Academy of Environmental Medicine. The Respondent has owned the LISTEN device since 1997, when he bought it from the company owned by James Clark. The LISTEN device was made in Utah.
1.9 The Respondent learned to operate the LISTEN device from his colleagues and from the manual, which told him how to operate it. The manual did not make any claims on its use and provided basic instructions on how to turn it on and off. The LISTEN device had no labeling on it.
1.10 He also sent his office nurse to a course to learn about the LJSTEN device. The nurse learned how to use it for Electrodermal Screening (EDS). On one hand, this was not helpful because he does not do EDS. On the other hand, it was helpful because it increased his understanding and knowledge about the device. The Respondent obtained information about the LISTEN device from others colleagues, including Dr. Nambudripad, who uses a machine similar to it, but who purchased it from a different manufacturer.
1.11 Before the Respondent purchased the LISTEN device, he talked with James Clark who informed him that it was registered with the FDA. The Respondent purchased a device that could be sold to him by the manufacturer. The Respondent purchased the LISTEN device in good faith.
1.12 Although the Respondent does not charge his patients specifically for its use, the Respondent bills his patients for visits that include the LISTEN device's use. The device helps in his assessment and speeds up his patient visits. When he sees a patient, the LISTEN device is part of the whole picture of assessment and treatment.
1.13 The Respondent saw Patient One on tWo occasions: June 6, 2001 and July 10. 2001. At the initial visit, Patient One informed the Respondent that he had been tired. Just before the initial visit, Patient One filled out a health history provided by the Respondent. Patient One described the symptoms that he felt the day of the initial visit. Patient One felt fatigue and experienced sluggishness and that these symptoms were severe. Patient One frequently tired easily and felt weak. He experienced apathy and lethargy and the symptoms were severe.
1.14 At the initial visit, the Respondent discussed metal toxicity and metal poisoning with Patient One. The Respondent talked about his alternative medicine practice and informed Patient One that he would send him to the Tn-Cities laboratory for blood and urine testing. The Respondent took a hair sample. The first visit lasted about 30 to 45 minutes.
1.15 During the second visit on July 10, 2001, the Respondent reviewed Patient One's laboratory tests results. The Respondent reported to Patient One that he had a mineral imbalance, mineral deficiencies, and that his testosterone level should be higher. He reported that Patient One might have some metal poisoning which would contribute to the tiredness. He informed Patient One that he should undergo treatment for the metal poisoning. The Respondent also informed Patient One that foods like eggs and mustard could be weakening his body.
1.16 The Respondent informed Patient One that he had a machine that could be used to find out what was going on with his body. The machine that the Respondent was referring to was the LISTEN device. The Respondent informed Patient One that he would place a probe in his hand and the probe was connected to the LISTEN device. The Respondent informed Patient One that the LISTEN device helped him make a diagnosis. The Respondent informed Patient One that he could cure the egg allergy and that eggs would not bother him again.
1.17 Before using the LISTEN device, the Respondent assessed the strength of Patient One's deltoid muscle to obtain a baseline. The Respondent had Patient One lie on his back. The Respondent put the probe in Patient One's right hand and raised Patient One's right arm to a 90 degree point from his body. Patient One had a ring on his left-hand and on his right wrist he wore a watch. The Respondent asked Patient One to resist as hard as he could while the Respondent tried to pull his arm down next to Patient One's body. During this test, Patient One resisted pretty well and Patient One's resistance was strong.
1.18 The Respondent used the LISTEN device when he conducted the next muscle assessment. While Patient One was still lying on his back, the Respondent put the probe in Patient One's right hand and raised Patient One's right arm to a 90 degree point from his body. This time the Respondent had the LISTEN device operating and, using the keyboard, he typed in the word "eggs." The Respondent again asked Patient One to resist as hard as he could while the Respondent tried to pull Patient One's arm down. This time the Respondent was then able to easily pull Patient One's arm down. When this occurred, the Respondent informed Patient One that he could pull his arm down, because his body had been compromised due to the egg allergy.
1.19 Next, for the treatment, the Respondent had Patient One roll over on his stomach and the Respondent thumped Patient One on his back with an acupressure device. The device had rubber tips on it like a plunger. While the Respondent thumped Patient One on his back, he mentioned acupressure.
1.20 After the acupressure treatment, the Respondent assessed whether it affected the muscles. The Respondent had Patient One roll over on his back again and the Respondent gave Patient One the probe that was connected to the LISTEN device. The Respondent had Patient One raised his arm to a 90 degree position and the procedure was repeated. The Respondent could not pull Patient One's arm down. The Respondent then said "See, it's gone."
1.21 After the Respondent used the LISTEN device, the Respondent performed an final assessment. The Respondent wrapped the probe in tissue paper and then had Patient One hold the probe with the tissue paper wrapped around it. Patient One asked him why he did this. The Respondent answered that he has done this so long, that he could do what the machine could do, and that he did not need the machine anymore.
1.22 After this series of assessments and treatment, the Respondent advised Patient One that he should not eat any eggs for 24 hours or perhaps 48 hours or the treatment would not take. Patient One understood that the Respondent had diagnosed that he was allergic to eggs, that the Respondent provided treatment, and that the Respondent cured him of his egg allergy. Patient One understood that he would be able to eat eggs and would have no allergic reaction.
1.23 In 1976-80, Patient One had been diagnosed by another health care practitioner that he was allergic to blowing dust and pollens for which Patient One took shots to help relieve the symptoms. He had also been diagnosed with hay fever, with resulting symptoms of respiratory difficulties, feeling plugged-up, sinus drainage, and itching of eyes.
1.24 At the end of the second visit, the Respondent informed Patient One that he could only treat one allergy at a time and that he would need to come in for additional visits to treat each allergy. The Respondent wrote out some prescriptions and suggested that the Respondent sign up for additional treatments. The Respondent prescribed testosterone, DHEA. multi-mineral vitamins and a low glycemic index diet to be followed by a Metabolic typing diet.
1.25 As a physician, the Respondent used the LISTEN device to treat Patient One for an egg allergy. The LISTEN device was inefficacious and did not cure an egg allergy. The LISTEN device did not provide any manner of treatment or assessment. Before the Respondent's assessment and treatment for an egg allergy, Patient One had not been diagnosed to be allergic to eggs or mustard or any food allergies. There was no clinical evidence to support the Respondent's assessment and treatment that Patient One had an egg allergy. Before his visit with the Respondent, Patient One had not been advised that he was allergic to eggs and had no reaction to eating eggs, except that he does not like to eat them.
1.26 The Respondent promoted the use of the LISTEN device in his practice and for his own personal gain. He informed Patient One that he uses it for treatment. He billed Patient One for his treatment, which included using the LISTEN device. The Respondent was able to speed up his assessment and treatment by using it. He suggested to Patient One to return for additional treatments so he can treat each individual allergy.
1.27 As a physician, the Respondent failed to take the necessary safety measures to ensure that the LISTEN device would not be harmful to his patients. The Respondent obtained no literature or had no labeling on the LISTEN device, and he did not receive any personal training on its use. The Respondent only listened to his colleagues and to a salesperson. The Respondent did not know the voltage or amperage that the LISTEN device produces.
1.28 The Respondent's use of the LISTEN device, an inefficacious device, precluded him from making as a physician an appropriate diagnosis and treatment. By using his credentials as physician, the Respondent took advantage of Patient One to use an inefficacious device to allegedly assess, treat and cure an egg allergy. By using the LISTEN device in his assessment and treatment of Patient One on July 10, 2001 for an egg allergy, the Respondent was negligent in his practice as a physician. The Respondent's use of the LISTEN device was not nontraditional treatment.
1.29 Making a false medical diagnosis through the use of an inefficacious device, providing an ineffective treatment, and misinforming Patient One that he had been cured, the Respondent subjected him to unreasonable risk of harm. The Respondent's reliance on the LISTEN device, an inefficacious device, created an unreasonable risk of harm to Patient One.
II. CONCLUSIONS OF LAW
2.1 The Commission has jurisdiction over the Respondent's license and over the subject matter of this proceeding. RCW 18.71; RCW 18.130.
2.2 The Washington Supreme Court has held that the standard of proof in disciplinary proceedings against physicians before the Washington State Medical Quality Assurance Commission is proof by clear and convincing evidence. Nguyen v. Department of Health, 144 Wn.2d 516,534, cert. denied, 535 U.S. 904 (2002).
2.3 Based upon Findings of Fact, Paragraphs 1.1, 1.2 and Paragraphs 1.7 through 1.30 above, along with the above Analysis, the Commission concludes that the Department proved by clear and convincing evidence that Respondent violated RCW 18.130.180(4) and (16).
2.4 Based upon Findings of Fact, Paragraphs 1.1 through 1.6 above, along with the above Analysis, the Commission concludes that the Department failed to prove by clear and convincing evidence that Respondent violated RCW 18.130.180(7). This charge under RCW 18.130.180(7) shall be dismissed.
2.5 Based upon Findings of Fact, along with the above Analysis, the Commission concludes that the Department failed to prove by clear and convincing evidence that Respondent violated RCW 18.130.180(1). The Respondent purchased the LISTEN device in good faith. The decision to use an inefficacious device, even though its use resulted in unprofessional conduct, did not constitute an act of moral turpitude, dishonesty, or corruption. This charge under RCW 18.130.180(1) should be dismissed.
2.6 As a result of the unprofessional conduct found under RCW 18.130.180(4) and (16), the Commission may impose sanctions. The first consideration is the protection of the public. RCW 18.130.160.
2.7 Based upon the above Findings of Fact, Analysis and Conclusions of Law, the Commission concludes that the Respondent's license should be suspended, but the suspension should be stayed provided that he complies with the conditions ordered below. The Respondent should not be permitted to use the LISTEN device with patients. The Respondent should pay a fine for his conduct and he should be monitored during this period of stayed suspension, including a regular review of his patient records. The Commission concludes that these conditions are necessary to ensure that sufficient safeguards are in place to protect the public.
Based on the foregoing, the Commission hereby issues in this case the following ORDERS:
3.1 Stayed Suspension. The license to practice as a physician and surgeon in the state of Washington held by the Respondent, Geoffrey S. Ames, M.D., is SUSPENDED for a period of at least five (5) years from the date of service of this Order. The suspension of the Respondent's license is hereby STAYED, PROVIDED that the Respondent complies with the following terms and conditions in this Order.
3.2. Limitation on Practice. The Respondent shall not use the LISTEN device to assess for or to treat allergies. Further, the Respondent shall not have the LISTEN device in his medical office(s) where he sees and/or treats patients.
3.3 Record Reviews. Within thirty (30) days from the effective date of this Order, or as soon thereafter as deemed by the Commission or its designee, the Department shall conduct a review of 10 to 15 patient records, randomly selected, on a quarterly basis. After a compliance hearing in review of this condition, the Commission at its discretion may order the record reviews to continue this quarterly review of the Respondent's records for an additional period as long as the Commission deems it necessary.
3.4 Quarterly Declaration. The Respondent shall submit a quarterly declaration under penalty of perjury stating whether there has been compliance with all conditions of the Order. The quarterly declarations shall be submitted to the Commission on the first day of the following months: September, December, March and June, unless ordered otherwise by the Commission.
3.5 Compliance with Laws and Rules. The Respondent shall obey all federal, state, and local laws and all rules governing the practice of medicine and surgery in the state of Washington.
3.6 Fine. The Respondent shall pay an administrative fine to the Commission in the amount of $5,000 (five thousand dollars) within 180 days of the entry of the effective date of this Order. The payment shall be made payable to the Washington State Treasurer and sent to the following address:
Medical Quality Assurance Commission
P.O. Box 1099
Olympia, WA 98507-1099
3.7 Appearance at Compliance Hearings. The Respondent shall appear before the Commission six months from the effective date of this Order, or as soon thereafter as the Commission's schedule permits, and shall present proof that he is complying with this Order. He shall continue to make such compliance appearances every six months. or as frequently as the Commission otherwise requires, until the period of stayed suspension, is terminated by the Commission. The Respondent shall be given notice of the compliance hearing, and if he fails to comply with this Order, the Commission may impose other sanctions as appropriate under RCW 18.130.160 to protect the public. Further, after a compliance hearing, the Commission may determine that the Respondent is in compliance and that he need not personally appear for a six-month compliance hearing.
3.8 Costs. The Respondent shall be responsible and shall pay for any and all costs involved in his compliance with any and all conditions in this Order.
3.9 Responsibility for Providing Current Address. The Respondent shall ensure that the Commission has his current practice and residence addresses and telephone numbers. The Respondent shall notify the Commission in writing of any address change within twenty (20) days after the change.
3.10 Placed on Notice. The Respondent is hereby placed on notice that it is his responsibility to ensure that all required reports are submitted to the Commission on time and in the manner specified in this Order.
3.11 Periods of Out of State Practice. In the event the Respondent should leave Washington State to practice or reside outside the state, the Respondent shall notify the Commission, in writing, of the date of departure and return. Periods of residency or practice outside Washington State will not apply to the reduction of this five (5) year period of suspension.
3.12 Modification of Order. Except as provided above, the Respondent may petition the Commission for modification of this Order no sooner than five (5) years from the date this Order is signed. Upon notice duly given by the Commission, the Respondent shall appear personally before the Commission to present evidence in support of the petition. Evidence in opposition to the petition may also be presented for the Commission's consideration. The Commission has sole discretion to grant or deny the Respondent's petition for modification and has the authority to impose restrictions and/or conditions on the Respondent's license to practice as long as the Commission's jurisdiction over the Respondent, pursuant to this Order, continues.
3.13 Termination of this Order. After the Respondent completes the conditions of the stayed suspension and after five (5) years from the effective date of this Order, the Respondent may file a petition for termination of the stayed suspension and for a license to practice medicine and surgery in the state of Washington without restrictions and conditions. At a hearing on the petition, the Department may present evidence in opposition to be considered by the Commission. After considering the petition and the evidence presented, the Commission has the sale discretion to grant or deny the Respondent's petition and has the authority to remove or to impose restrictions and/or conditions on the Respondent's license to practice as long as the jurisdiction remains over the Respondent, pursuant to this Order.
3.14 Violation of Order. If the Respondent violates any provision of this order, the Commission, after giving the Respondent notice and the opportunity to be heard, may set aside the stay order and impose the suspension, or may impose any sanction as it finds appropriate under RCW 18.130.160, or may take emergency action ordering summary suspension restriction or limitation of the Respondent's practice as authorized by RCW 18.130.150.
3.15 The charges in this matter that the Respondent's conduct violated RCW 18.130.180(1) and (7) are DISMISSED.
Dated this 30th day of May, 2004.
Medical Quality Assurance Commission
CABELL TENNIS, J.D.