On August 10, 2020, on the basis of an Statement of Uncontested Facts and Plea of No Contest (Liability), the Discipline Committee found that Dr. George Douglas Gale (“Dr. Gale”) committed an act of professional misconduct in that he has failed to maintain the standard of practice of the profession, under paragraph 1(1)2 of Ontario Regulation 856/93 made under the Medicine Act, 1991.
FACTS
Background
Dr. Gale is an 85-year-old anesthesiologist. He graduated from the University of Durham in the United Kingdom in 1958 and received his certificate of registration authorizing independent practice from the College of Physicians and Surgeons of Ontario (the “College”) in 1971.
In his annual renewals filed with the College between 2013 and 2018, Dr. Gale described that he spends 90% of his clinical practice in the area of chronic pain management without general/spinal anesthesia. At the relevant times, a large portion of Dr. Gale’s practice was devoted to injection therapies for chronic pain, including but not limited to nerve block and trigger point injections.
Registrar’s Investigation
In October 2014, the College received information from an Associate Medical Health Officer with Toronto Public Health regarding an adverse event experienced by a 91-year- old patient following a shoulder joint pain injection performed by Dr. Gale. In November 2014, the Inquiries, Complaints and Reports Committee of the College (the “ICRC”) approved an appointment of investigators under section 75(1)(a) of the Health Professions Procedural Code (the “Code”) to investigate whether Dr. Gale engaged in professional misconduct or is incompetent in his pain management practice.
As part of its investigation, the College retained a medical inspector to provide an opinion regarding Dr. Gale’s pain management practice. In a report dated August 5, 2015, the medical inspector raised significant concerns regarding Dr. Gale’s standard of practice and opined that in 19 out of 25 charts that he reviewed, Dr. Gale’s care exposed his patients to harm or injury.
Undertaking and Clinical Supervision
As a result of the Registrar’s Investigation, on December 21, 2015, Dr. Gale signed an Undertaking with the College that required him to practice under the guidance of a clinical supervisor for nine months, engage in professional education, and submit to a reassessment of his practice approximately six months following his clinical supervision. In January 2016, the ICRC accepted Dr. Gale’s December 21, 2015 Undertaking and also required Dr. Gale to attend before the ICRC to be cautioned in person on the prevention, diagnosis and treatment of infection.
Pursuant to his December 21, 2015 Undertaking, Dr. Gale practiced under the guidance of a Clinical Supervisor from February 2016 to November 2016.
Failure to Maintain the Standard of Practice
Following Dr. Gale’s clinical supervision, the College retained Dr. George Evans, MD, FRCPC Anesthesiology and Chronic Pain, to conduct the reassessment of Dr. Gale’s practice pursuant to Dr. Gale’s December 21, 2015 Undertaking with the College. Dr. Evans is an Anesthesiologist and Chronic Pain Physician at the Ottawa Hospital and has served as the Ottawa Hospital’s Pain Fellowship Director and Pain Residency Director.
Dr. Evans prepared a report dated April 19, 2018, based on a review of 15 medical charts and an interview with Dr. Gale. Subsequently, Dr. Evans provided an addendum report to respond to the questions of whether the care provided by Dr. Gale met the standard of practice of the profession and whether a risk of harm or potential risk of harm was identified. Dr. Evans’ initial report and his addendum report were provided in one report, dated July 26, 2018.
Dr. Evans opined that in seven out of the 15 charts he reviewed, the care provided to the patient by Dr. Gale did not meet the standard of practice. Dr. Evans further opined that eight out of the 15 charts displayed a lack of knowledge; three out of the 15 charts displayed a lack of judgment; three out of the 15 charts displayed a lack of skill; and seven out of the 15 charts indicated clinical practice, behaviour or conduct which exposes or is likely to expose Dr. Gale’s patients to harm. In his report, Dr. Evans expressed the following concerns, among others:
- Dr. Gale’s knowledge and appropriate use of nerve blocks appeared to be inadequate.
- With respect to two patients, Dr. Gale provided an excessively vague diagnosis and/or lack of appropriate diagnosis:
- In Chart #4, Dr. Gale provided an excessively vague diagnosis of “biomechanical disorder of the spine” with no reference to any level, i.e., cervical, thoracic, lumbar or sacral.
- In Chart #10, Dr. Gale continued providing frequent nerve blocks despite minimal effect and minimal changes in the patient’s function. The patient was eventually assessed by an orthopedic spine surgeon, who did not recommend injections other than a possible trial of facet injections and who believed that the patient’s leg pain may be vascular in nature and not radicular pain. The patient eventually underwent successful vascular surgery.
- With respect to Charts #6 and 10, Dr. Gale performed multiple sciatic nerve blocks on the patient with no indication for the blocks. With respect to Chart #6, there was no diagnosis to justify the blocks and Dr. Gale continued performing the blocks with minimal relief and a lack of notes justifying the practice.
- With respect to Charts #3, 8, 9, 10, 11 and 13, Dr. Gale performed sciatic nerve blocks with low volume and no image guidance or nerve stimulation. Sciatic nerve blocks performed with low volumes and no image guidance or stimulation are unlikely to block the sciatic nerve and puts the patient at increased risk of injection into other deep structures, vessels, and nerves, and other complications.
- Dr. Gale appeared to have a lack of knowledge in that a small volume, i.e. 3 cc, would be able to block the sciatic nerve or pudendal nerve without ultrasound guidance, fluoroscopic guidance or with the use of a nerve stimulator. Normal volume for this type of block even under image guidance or nerve stimulation is 15 - 20 cc for therapeutic procedures. Using a volume of less than 5 cc is not likely to block the sciatic nerve without image guidance.
- In Charts #1, 3, 6, 8, 9, 10, 11 and 13, Dr. Gale’s chart notes were inadequate in relation to the procedures provided, technique of blocks provided, which sterile prep solution was used, needle(s) size and gauge, which nerve was injected or how it was localized, and/or local anesthetic amounts used. Patient chart notes should adequately describe the technique used and needle size and length, so that if there are any complications, it would be easier for Dr. Gale or another physician to differentiate and work up potential complications with greater accuracy.
- With respect to multiple patients, Dr. Gale performed multiple weekly injections on the patient with minimal relief and a lack of notes justifying the practice. For example:
-With respect to Chart #6, the patient underwent multiple weekly injections despite that various progress notes describe the patient’s pain relief from the blocks at only 10% or 20% for hours. There is no note justifying the continued use of frequent blocks with such a small amount of relief.
-With respect to Chart #8, Dr. Gale continued multiple level weekly nerve blocks despite that the progress notes describe minimal to no pain relief and, according to the patient, no effect on life. Dr. Gale’s notes describe improvements in all functional areas of functional status, despite the patient’s reports that the blocks only help minimally and for minimal duration and did not make any significant life change.
-With respect to Chart #10, Dr. Gale continued weekly injections despite that the patient was only getting 20% to 30% pain relief for 1-2 days or less. Dr. Gale’s notes described improved areas of function but no actual description of any improvements.
According to Dr. Evans, if a patient fails to have adequate relief after nerve blocks on two occasions, no further blocks in the same area should be offered. The physician caring for the patient should re-examine and re-assess the diagnosis and re-evaluate if nerve blocks are indicated. Failing to stop doing procedures when there is inadequate response puts patients at unnecessary risks of complications and pain from the injections themselves.
-Dr. Gale failed to appropriately refer patients to other specialists. For example:
-With respect to Chart #1, Dr. Gale referred the patient for epidural steroids, which was not appropriate or indicated. A referral for other interventions such as SI joint injection/ablation, facet injection or ablation would have been more appropriate. Dr. Gale did not appear to know that axial pain or spondylosis is not a reason for referral to neurosurgery or for epidural injections. In the referral, there is no noted radicular pain/disc
herniation, which would be a diagnosis where epidural steroids are appropriate. Furthermore, the patient was referred to a neurosurgery/surgical consultation service that does not do epidural steroids.
-With respect to Chart #6, Dr. Gale continued to perform multiple weekly injections with minimal relief and no consideration or referral for a possible more lasting treatment such as facets blocks or ablation, SI injection with steroids under imaging guidance or possible ablation.
-Dr. Gale appeared to over rely on EMG testing to diagnose radicular pain or radiculopathy that could benefit from epidural steroids or surgical evaluation.
Dr. Gale’s Interim Undertaking Restricting his Practice
On November 14, 2019, Dr. Gale entered into an Undertaking with the College in lieu of the ICRC making an interim order under section 25.4 of the Code. Dr. Gale’s November 14, 2019 Undertaking restricts him from performing interventional pain procedures.
PENALTY
FACTS
The facts on penalty were as follows:
Dr. Gale’s History with the College
Discipline History with the College
On December 3, 2001, following a hearing, the Discipline Committee of the College found that Dr. Gale failed to meet the standard of practice of the profession. Dr. Gale appealed the findings and penalty to the Divisional Court. In a judgment dated October 10, 2003, the Divisional Court set aside a portion of the Discipline Committee’s findings. The Divisional Court upheld the Discipline Committee’s finding that Dr. Gale failed to maintain the standard of practice of the profession based on his care and treatment of one patient and his use of heavy sedation/general anesthesia with nerve blocks. The Divisional Court remitted the issues of liability it had set aside, as well as penalty, for consideration before a differently constituted panel of the Discipline Committee. The Discipline Committee reconsidered the matter on May 10, 2004. The College did not conduct a new hearing into the liability issues set aside by the Divisional Court. Based on a joint submissions to penalty, the Discipline Committee ordered that Dr. Gale undertake an assessment of his competence through a Specialty Assessment Program by the Quality Assurance Committee (“QAC”) of the College, that Dr. Gale comply with the QAC’s recommendations, and that Dr. Gale comply with any terms, conditions and limitations which the QAC may direct the Registrar to impose on his certificate of Registration.
Past Inquiries, Complaints and Reports Committee and Complaints Committee Decisions
In September 2001, the Complaints Committee of the College considered the investigation of a complaint made by another member of the College. That member complained about comments that Dr. Gale had made in a medical publication. The Complaints Committee cautioned Dr. Gale in writing to refrain from referring to his colleagues in an unprofessional manner.
In June 2009, the Inquiries, Complaints and Reports Committee of the College (the “ICRC”) considered an investigation of Dr. Gale’s practice after information was received from the College’s Quality Assurance Committee that Dr. Gale may be incompetent regarding his chronic pain management practice. The ICRC determined that no action would be taken with respect to the matter.
In September 2010, the ICRC considered the investigation of a complaint by one of Dr Gale’s patients. The patient complained, among other things, that Dr. Gale failed to provide adequate treatment in the management of her care in that he failed to wipe her arm with alcohol prior to administering nerve block injections and failed to take her blood pressure after the nerve block injections were given. The ICRC cautioned Dr. Gale in writing to ensure that he undertakes appropriate post-procedure monitoring of patients and that he documents same.
On April 8, 2020, the ICRC considered the investigation of a complaint by a member of the public. The complainant was concerned about Dr. Gale’s role at a clinic at which an unlicensed individual was holding himself out to be a physician and prescribing medical marijuana. In response to the complaint, Dr. Gale signed an Undertaking with the College in which he agreed to restrict his practice by ceasing all practice relating to cannabis. A copy of the April 8, 2020 ICRC Decision and Reasons is attached at Tab 8 to the Agreed Statement of Facts (Penalty).
Reports of Dr. Partridge and Dr. Evans
Dr. Michael Partridge was asked for his opinion on Dr. Gale’s non-interventional pain practice. Dr. Partridge reviewed the 15 cases from Dr. Gale’s practice that were reviewed by Dr. George Evans as well as Dr. Evans’ expert opinion report dated July 26, 2018. Based on Dr. Partridge’s review of the 15 cases reviewed by Dr. Evans, Dr. Partridge opined that Dr. Gale’s non-interventional pain practice is within the standard of care.
Dr. Evans was provided with a copy of Dr. Partridge’s May 20, 2020 opinion report. In response to Dr. Partridge’s May 20, 2020 opinion report, Dr. Evans provided an Addendum Report dated June 9, 2020, that included the following comments:
- In this report Dr. Micheal [sic] Partridge does not review any of the interventional pain procedural care that was provided. This review of cases misses on significant amounts of the practice and care provided by Dr Gale at that time. I don’t believe it is appropriate to only asses a portion of the care provided at that time, in order to determine if Dr Gale’s practice met the standard of care at that time. Therefor this review does not change my opinion as previously stated (Reports dated July 26, 2018 and November 4, 2018).
- …
- In summary, the report by Dr. Micheal Partridge does not change my opinion in relation to the care provided by Dr Gale at the time of the review. I would suggest after such a significant change in his pain practice, that a new chart review would be needed in order to determine if his current practice meets standard of care and does not expose patients to undo [sic] risk.
Dr. Gale’s Undertaking
Dr. Gale has entered into an undertaking to the College, dated August 6, 2020. Dr. Gale has undertaken not to perform any interventional pain procedures as set out in Appendix “A” to the Undertaking, effective immediately.
The Committee ordered:
-Dr. Gale is to be reprimanded;
-The Registrar is to impose terms and conditions and limitations on Dr. Gale’s certificate of registration, including Clinical Supervision to be followed by a reassessment
Dr. Gale is pay costs to the College of $6,000.00 within 90 days of the date of the Order.
Terms and conditions imposed on certificate by: Member