Health Care Complaints Commission v Petros [2019] NSWCATOD 83
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Civil and Administrative Tribunal
New South Wales
Medium Neutral Citation: Health Care Complaints Commission v Petros [2019] NSWCATOD 83
Hearing dates: 1, 2, 3, 4, 5 April 2019; 6 May 2019
Date of orders: 28 May 2019
Decision date: 28 May 2019
Jurisdiction: Occupational Division
Before: D Cowdroy OAM QC ADCJ, Principal Member
Dr M Nicholl, Senior Member
Dr J King, Senior Member
S Lovrovich, Community Member
Decision: 1. Order that if the respondent were still registered: -
i. Pursuant to section 149C (4) (a) of the National Law if the respondent were still registered his registration would have been cancelled;
ii. Pursuant to section 149C (4) (b) the respondent be disqualified from being registered as a medical practitioner for two years;
iii. Pursuant to 149C (4) (c) of the National Law the National Board record that the Tribunal would have cancelled the respondent's registration in the National Register kept by the Board;
iv. Pursuant to section 149C (7) of the National Law order that the respondent cannot seek a review of the orders made by the Tribunal for a period of two years
v. Pursuant to section 163 of the National Law the Tribunal is the appropriate review body for any review of these orders;
2. The respondent is to pay the costs of the applicant and incidental to these proceedings.
3. The publication of the name of any patient referred to in this decision be prohibited.
Catchwords: PROFESSIONS AND TRADES – health care professionals – medical practitioners – disciplinary proceedings – intellectual property in device used in pelvic floor surgery – practitioner having financial interest through family trust and company structures in the device - device used in operative procedures – patients not informed by the practitioner that he was and that he had a financial interest in such device – practitioner failing to inform Medical Advisory Council (MAC) of private hospital where he was granted operating rights of his financial interest in the device - registration of device cancelled by the Australian Therapeutic Goods Authority – practitioner continuing to use device in operative procedures without informing patients of financial interest and of the fact of cancellation on the Australian Therapeutic Goods Registrar of the registration of the device –
Medical Malpractice – practitioner supervising surgery – complications in surgery resulting in urgent transfer of patient to a public hospital – practitioner failing to provide information to the receiving medical staff at the hospital that the patient had undergone surgery involving the use of the device
Legislation Cited: Health Care Complaints Act 1993 (NSW)
Health Practitioner Regulation National Law (NSW)
Cases Cited: Briginshaw v Briginshaw [1938] HCA 34; (1938) 60 CLR 336
Commissioner of Taxation v Bamford [2010] HCA 10
FTZK v Minister for Immigration and Border Protection [2014] HCA 26
Health Care Complaints Commission v Liu [2016] NSWCATOD 133
Health Care Complaints Commission v Philipiah [2013] NSWCA 342
Health Care Complaints Commission v Sare [2018] NSWCATOD 190
O'Connell v Palmer (1994) 53 FCR 429
R v Byrnes and Hopwood [1995] HCA 1; 183 CLR 501
Category: Principal judgment
Parties: Health Care Complaints Commission (Applicant)
Peter Petros (Respondent)
Representation: Counsel:
K Richardson SC, C Mitchell (Applicant)
P Griffin SC, T Fishburn (Respondent)
Solicitors:
Health Care Complaints Commission (Applicant)
Meridian Lawyers (Respondent)
File Number(s): 2018/00117097
Publication restriction: The publication of the name of any patient referred to in this decision be prohibited.
REASONS FOR DECISION
1. By Application disciplinary findings and orders filed on 13 April 2018 the applicant (referred to hereunder as the "applicant" or "HCCC") seeks various orders under the Health Practitioner Regulation National Law (NSW), hereafter referred to as "the National Law", in relation to the respondent (referred to as the "respondent" or "the practitioner" or "Dr Petros"). The applicant seeks orders under section 149A, namely power to caution, reprimand, impose conditions on registration; section 149B (imposition of a fine); and/or section 149C (suspension or cancellation of registration).
2. Three specific complaints are made against the respondent, who was formerly registered as a medical practitioner under the provisions of the National Law.
3. Because of the complexity of the complaints, a summary is provided hereunder.
Executive Summary of Complaint One
1. Complaint Number One alleges that the practitioner who is a gynaecologist specialising in pelvic floor reconstruction, failed to disclose to patients his financial interest in a medical device known as the Tissue Fixation System (TFS) medical device ("the device"). The applicant, through a family company, had applied, and obtained registration for the patent and also obtained approval from the Australian Therapeutic Goods Registration Authority (ARTG). This Complaint also alleges that the practitioner attempted to mislead the HCCC on more than one occasion in relation to the disclosure of such interest.
2. The respondent commenced practice in New South Wales as an obstetrician and gynaecologist from 1969. Dr Petros travelled frequently to Sweden, but maintained his practice in Perth during this time. The applicant practised as a specialist gynaecologist in Western Australian from 1986, before recommencing practice in New South Wales in approximately 2005. He obtained rights from the Medical Advisory Committee (MAC) of Sydney Private Hospital to conduct his practice in Sydney, at the Sydney Private Hospital (TSPH). Dr Richard Reid was also a specialist gynaecologist having right to practice at that hospital. As a result of certain events, the respondent was requested by TSPH to supervise Dr Reid.
3. In addition to Dr Reid, the practitioner became closely associated with Dr Darren Gold. They performed surgery together, as is set out in more detail hereunder.
4. Kvinno Pty Ltd was the practitioner's family company which was the owner of 100% of the intellectual property in the device. The practitioner was a director of the company until 2005. In that year his wife and son were directors of Kvinno. Sappho Pty Ltd, as trustee of the Petros Family Trust, and held 100% of the shareholding in Kvinno.
5. The directors of Sappho Pty Ltd were, until 7 July 2014, the practitioner and his wife. On 7 July 2014 the practitioner transferred his shareholding to his son. On that date his son was substituted as a director.
6. By an Intellectual Property Licence Deed dated 1 November 2008 Kvinno granted the rights to manufacture the device to another company known as TFS Manufacturing Pty Ltd (referred to hereunder as "financial interest 1"). However all ownership of the intellectual property remained with Kvinno.
7. Upon the sale of the device, 75 to 100% of the sale proceeds would pass to Kvinno (referred to hereunder as "TFS Manufacturing").
8. Sappho Pty Ltd lent substantial sums to TFS Manufacturing by way of unsecured loans. By 2016, the loans amounted to $1.6 million (referred to hereunder as "financial interest 3").
Failure to disclose financial interest
1. Between 4 June 2013 and 24 October 2014 the respondent performed surgery on 108 patients involving the TFS device. The practitioner did not disclose to any patient concerning his, or his family members financial interest in the TFS device ("the disclosure") nor ensured that the lead surgeon was aware of his and his family members financial interest in the device.
2. In respect of two patients whose surgeries were performed on 28 March 2014 and 24 October 2014 using the TFS device the practitioner failed to disclose to the patient or to the lead surgeon of practitioners and his family's interest in the device.
3. During the course of the hearing the practitioner admitted that such disclosures were not made. The practitioner also admitted the factual evidence relating to the Petros family Trust, the company structures and the changes made to the Trust and company structures on 7 July 2014.
4. The practitioner acknowledged that it was improper not to have done so. However the practitioner maintained that he did not consider that the Trust and company structures had the effect of giving him a direct interest in the TFS device. He states that it was for this reason that he was not required to disclose such interest. The practitioner denied such conduct in failing to disclose such financial interests constituted unethical conduct as alleged.
5. The practitioner states that he received advice only after the hearing commenced that he was obliged to make such disclosures to his patients.
6. On 5 November 2014 the ARTG cancelled the registration of the device. The practitioner was aware of such cancellation but failed to disclose that fact to 9 patients who underwent surgery using the TFS device between 15 November 2014 and 13 February 2015. In respect of their surgery, Dr Darren Gold was the surgeon and the practitioner was the surgical assistant, but due to complications, the practitioner took control of the surgery in two of these cases.
7. Again, during the hearing the practitioner acknowledged that he made no disclosure, and acknowledged that such conduct was improper, but not unethical.
Supply of misleading information to HCCC
1. Following a complaint by a patient concerning the lack of disclosure by the practitioner, the applicant, by letter dated 18 June 2014, sought details from the practitioner concerning his alleged financial interest. In response dated 11 July 2014 the practitioner stated that he no longer had a financial interest in the TFS device but failed to disclose that he removed himself as a residuary beneficiary under the Petros Future Trust and resigned as a director of Sappho only four days before his response was written to the applicant. Further, he failed to disclose that his family members continued to hold financial interests 1, 2, and 3.
2. On 20 October 2015 the practitioner was interviewed by the applicant. At such interview the practitioner told the applicant that he had divested himself of any commercial interest in the TFS device but did not mention his family's continuing financial interest in the device, nor of his interest through his family trust, which he held until July 2014.
3. When further detail was sought by the applicant, the intellectual Property Licence Deed ("the deed") was provided. It omitted the page which stated that Kvinno was the sole and beneficial owner of the intellectual property in the device. The practitioner thereafter informed the HCCC that he did not have a copy of the deed. However, subsequently it was implied that all relevant times, a copy of the deed was in his possession, and the page was provided.
4. Despite further questions between July 2014 and August 2017 the practitioner did not disclose the unsecured, interest accruing loans from the Petros Future Trust to TFS Manufacturing. The practitioner disclosed a loan made by the trust of $62,000 to TFS Manufacturing. No mention was made of approximately $750,000 in loans made by the family trust to TFS manufacturing. Such loans comprised the principal asset of the family trust.
5. The applicant claims that it was deliberately misled by the above matters. The practitioner denies any intention to mislead.
Executive Summary of Complaint Two
1. The second complaint related to the alleged failure by the practitioner to properly handover a patient after the practitioner, as supervising surgeon and Dr Richard Reid as surgeon, had performed surgery including the insertion of a TFS device in the patient. Dr Petros was the supervising surgeon, as Dr Reid was subject to the MAC condition preventing him conducting surgery without Dr Petros present as supervisor. The patient suffered severe bleeding to the point where her condition became critical and she was transferred to St George Public Hospital.
2. The practitioner accompanied the patient in the ambulance, together with the anaesthetist. Initially the patient was to be transferred, at the request of the practitioner to St George Private Hospital, even though Royal Prince Alfred Hospital which had an Emergency Department, was closer to the Sydney Private Hospital. During the ambulance journey, a practitioner at the St George Private Hospital directed that the ambulance should go to St George Public Hospital Emergency Department.
3. The ambulance arrived at St George Public Hospital Emergency Department with the patient who was in a critical condition. The patient was handed over and the practitioner described surgery that had been undertaken. The applicant claims that no mention was made of the fact that a TFS device was used in the surgery, with the consequence that the receiving registrar had no knowledge of the specific type of procedure performed. The practitioner denies that his handover explanation was inadequate.
Executive Summary Complaint Three
Complaint 3
This complaint relies upon the conduct referred to in Complaints 1 and 2 above.
Applicant's Specific Complaint
1. Complaint One
COMPLAINT ONE
is guilty of unsatisfactory professional conduct under section 139B(1)(I) of the National Law in that the practitioner has:
i. engaged in improper or unethical conduct relating to the practice or purported practice of medicine.
Each particular in itself justifies a finding of unsatisfactory professional conduct. In the alternative, when two or more of the particulars are taken together, a finding of unsatisfactory professional conduct is justified concerning the practitioner's failure adequately to disclose his or his family members' financial interests in the Tissue Fixation System (TFS) medical device.
BACKGROUND TO COMPLAINT ONE
The practitioner
A. The practitioner was first registered to practise as a medical practitioner in NSW in 1964.
B. The practitioner was a Reconstructive Pelvic Floor Surgeon and a certified Urogynaecologist at all times relevant to this complaint.
C. The practitioner invented the TFS device.
D. The practitioner commenced working at The Sydney Private Hospital in Ashfield, New South Wales (the hospital) in May 2013.
E. The practitioner retired from practice in about November 2016.
The TFS Device
F. In 2002, the practitioner applied to the Therapeutic Goods Administration's (TGA) Australian Register of Therapeutic Goods (ARTG) for the registration of the "Petros Pelvic Ligament Anchor" (PPLA). The PPLA was included on the ARTG in around 2003 or 2004 and given ARTG No. 1326567.
G. The sponsor of the PPLA was a company named Kvinno Centre Pty Ltd (Kvinno). Kvinno was originally registered in 1972. The practitioner was a director of Kvinno from 1972 to 2005. At all material times since 2005, the practitioner's wife (Patricia Petros) and son (Emanuel Petros) have been the directors of Kvinno.
H. In 2004, TFS Manufacturing Pty Ltd (TFS Manufacturing) was registered. The practitioner was the sole director of TFS Manufacturing from 2005 to July 2009. In July 2009, Mr Paul Zadow also become a director and has remained so to date. The practitioner resigned as a director on 19 July 2011.
I. In October 2006, TFS Manufacturing wrote to the TGA regarding its application for inclusion of a medical device on the ARTG known as the TFS. The ARTG number quoted was the same ARTG number given to the application made by the practitioner (and sponsored by Kvinno) in 2002 for the PPLA. By letter dated 31 October 2006, the TGA notified TFS Manufacturing that the TFS had been included on the ARTG.
J. At all times since 2006, TFS Manufacturing has been the sole manufacturer of the TFS device worldwide.
Ownership of the TFS device technology and intellectual property
K. On or about 1 November 2008, an "Intellectual Property Licence Deed" (IPLD) was signed by Kvinno (the "licensor"), TFS Manufacturing (the "licensee") and Mr Paul Zadow and Mrs Robyn Zadow as Trustees for the Zadow Family Trust.
L. By Clause 2.1 of the IPLD, Kvinno granted to TFS Manufacturing "a fee-free, royalty-free, sole and exclusive license to use, exploit and commercialise the Technology and Intellectual Property..."
M. The IPLD defines "Technology" and "Intellectual Property" to mean, in effect, the TFS device and its implementation (including any improvements or modifications).
N. Clause 8 of the IPLD provides that if Kvinno sells the Intellectual Property, it is entitled to at least 75% of those proceeds, and 100% of the proceeds if Mr Zadow is not a shareholder of TFS Manufacturing at the time of the sale.
O. By Clause 10.2 of the IPLD, Kvinno warranted to TFS Manufacturing that Kvinno "has all necessary right and title to grant the License; and (b) it is the sole and beneficial owner of the Technology and the Intellectual Property."
The Petros Future Trust
P. The shares in Kvinno are 100% owned by Sappho Pty Ltd (Sappho).
Q. Sappho was registered in 1976. The practitioner was a director of Sappho from 1976 until 7 July 2014. At all times since 7 July 2014, the practitioner's wife (Patricia Petros) and son (Emanuel Petros) have been the directors of Sappho.
R. Sappho holds the shares in Kvinno on trust for the Petros Future Trust.
S. The Petros Future Trust was established on 1 April 2005. Relevantly:
a. from 2005 until 7 July 2014, the practitioner was a "residuary beneficiary" of the Petros Future Trust;
b. the practitioner's wife (Patricia Petros) is, and at all material times has been, a
"residuary beneficiary" of the Petros Future Trust;
c. three of the practitioner's children and grandchildren are, and at all material times have been, "primary beneficiaries" of the Petros Future Trust; and
d. on 7 July 2014, the practitioner retired as guardian and appointer of the Petros Future Trust and was replaced by his wife (Patricia Petros) and son (Emanuel
Petros).
Loans from the Petros Future Trust to TFS Manufacturing
T. In or about September 2009, the Petros Future Trust made a loan of $62,000 to TFS Manufacturing. The loan was repaid on 21 September 2014. The total interest earned in that period was $12,078.40.
T1. For the financial year ending 30 June 2012, the Petros Future Trust had on its balance sheet an unsecured loan in the amount of $656,623 to TFS Manufacturing and accrued interest on that loan in the amount of $68,377.
T2. For the financial year ending 30 June 2013, the Petros Future Trust had on its balance sheet an unsecured loan in the amount of $644,223 to TFS Manufacturing and accrued interest on that loan in the amount of $100,071.
U. For the financial year ending 30 June 2014, the Petros Future Trust had on its balance sheet an unsecured loan in the amount of $732,282 to TFS Manufacturing and accrued interest on that loan in the amount of $129,633.
V. For the financial year ending 30 June 2015, the Petros Future Trust had on its balance sheet an unsecured loan in the amount of $728,623 to TFS Manufacturing and accrued interest on that loan in the amount of $157,354.
W. For the financial year ending 30 June 2016, the Petros Future Trust had on its balance sheet an unsecured loan in the amount of $1,488,623 to TFS Manufacturing and accrued interest on that loan in the amount of $183,281.
PARTICULARS OF COMPLAINT ONE
1. From about September 2009 to 7 July 2014, the practitioner, as a residuary beneficiary of the Petros Family Trust, had the following financial interests in the TFS device:
a. the Petros Future Trust was the beneficial owner of 100% of the shares in
Kvinno, which in turn owned the technology and intellectual property in the
TFS device;
b. the Petros Future Trust, through its 100% beneficial ownership of the
shares in Kvinno, was entitled to at least 75%, and up to 100%, of the
proceeds of any sale by Kvinno of the intellectual property in the TFS
device;
c. the Petros Future Trust had a financial interest in the TFS device through the loans it made to TFS Manufacturing (see background paragraphs T and U above), the interest it charged to TFS Manufacturing in respect of
those loans, and the interest it had in recovering that principal and
interest; and
d. by reason of sub-particulars (a) to (c) above, the practitioner had financial
interests in the ongoing manufacture, sale, use and success of the TFS
device.
2. From about September 2009 to the present date, the practitioner's wife (Patricia Petros), son (Emanuel Petros) and grandchildren, as residuary or primary beneficiaries of the Petros Family Trust, have had the following financial interests in the TFS device:
a. the Petros Future Trust was the beneficial owner, through its 100%
beneficial ownership of the shares in Kvinno, of the technology and
intellectual property in the TFS device;
b. the Petros Future Trust, through its 100% beneficial ownership of the
shares in Kvinno, was entitled to at least 75%, and up to 100%, of the
proceeds of any sale by Kvinno of the intellectual property in the TFS
device;
c. the Petros Future Trust had a financial interest in the TFS device through the loans it made to TFS Manufacturing (see background paragraphs T to W above), the interest it charged to TFS Manufacturing in respect of those
loans, and the interest it had in recovering that principal and interest; and
3. The practitioner failed to disclose any, or alternatively sufficient, information about his or his family members' financial interests in the TFS device to The Sydney Private Hospital (the hospital) when seeking accreditation to the hospital on or about 11 March 2013 to work there as a surgeon, in circumstances where:
a. the practitioner knew or ought to have known that the TFS device was
going to be used at the hospital in surgeries in which he would be
operating;
b. the practitioner knew that the hospital could only purchase the TFS device from TFS Manufacturing Pty Ltd (TFS Manufacturing);
c. the practitioner knew, or ought to have known, that he and members of his family had financial interests in the TFS device;
d. the financial interests in the TFS device held by the practitioner and
members of his family were relevant and material financial interests for the
purpose of sections 8.11 and 8.12.5 of the Code of Conduct;
e. the circumstances described in particulars (1) and (2) above are referred to and repeated.
4. The practitioner failed to disclose any, or alternatively sufficient, information about his or his family members' financial interests in the TFS device, to the hospital's Medical Advisory Committee and/or credentialing committee when agreeing in May 2013 to supervise, mentor and/or assess (collectively "supervise") Dr Richard Reid in adopting a new style of surgical procedure in circumstances where:
a. the practitioner knew that the new style of procedure to be adopted by Dr Reid would largely involve the use of the TFS device:
b. the practitioner knew that Dr Reid was interested in, and intended to, use the TFS device for his surgeries in the future;
c. the period in which the practitioner would supervise Dr Reid would be
three months and possible longer depending on the practitioner's review
of Dr Reid's performance including his use of the TFS device in surgeries;
and
d. the circumstances described in particulars (1) and (2) above are referred to and repeated;
e. the circumstances described at sub-particulars 3(b) to (d) above are
referred to and repeated.
5. For each of the patients and surgeries listed in Annexure A, prior to the patient undergoing surgery involving the TFS device, the practitioner failed to disclose to the patient any, or alternatively sufficient, information about his or his family members' financial interests in the TFS device or ensure that the lead surgeon was aware of his and his family members' financial interests and had disclosed, or would disclose, these interests to the patient, in the following circumstances:
a. the circumstances described in particulars (1) and (2) above are referred to and repeated;
b. the circumstances described at sub-particulars 3(b) to (d) above are
referred to and repeated.
6. For each of the patients and surgeries listed in Annexure B, prior to the patient undergoing surgery involving the TFS device, the practitioner failed to disclose to the patient sufficient information about his or his family members' financial interests in the TFS device or ensure that the lead surgeon was made aware of his and his family members' financial interests and had disclosed, or would disclose, this to patients in circumstances where:
a. the practitioner knew there was a possibility that he would be the lead surgeon during the surgery;
b. the practitioner consulted with the lead surgeon and the patient prior to the surgery;
c. the circumstances described in particulars (1) and (2) above are referred to and repeated;
d. the circumstances described at sub-particulars 3(b) to (d) above are
referred to and repeated.
7. By letter dated 1 October 2014, TGA wrote to Mr Paul Zadow of TFS
Manufacturing notifying TFS Manufacturing of the cancellation of the TFS device from the ARTG effective 5 November 2014. On or around 5 November 2014 the practitioner knew of the cancellation of the TFS device from the ARTG including from his direct communication with Mr Zadow. After the practitioner became so aware he failed to personally inform patients who had agreed to undergo surgery involving the TFS device as set out in Annexure C, or ensure that the lead surgeon had informed, or would inform, patients of the following:
a. the TGA had authority to license surgical devices in Australia as listed in the ARTG;
b. the TFS device had been cancelled from the ARTG;
c. the reason or reasons for the removal of the TFS device from the ARTG and whether the practitioner or lead surgeon disagreed with or agreed with the cancellation and their reasons;
d. alternative approaches to surgery or why the practitioner or the lead
surgeon considered the use of the TFS device was still appropriate,
despite its cancellation from the ARTG;
e. the circumstances described in particulars (1) and (2) above are referred to and repeated;
f. the circumstances described at sub-particulars 3(b) to (d) above are
referred to and repeated.
8. The practitioner gave misleading information to the Health Care Complaints Commission (Commission) and/or made material omissions in his communications with the Commission about his and his family members' financial interest in the TFS device in each of the following circumstances:
a. in a letter to the Commission sent on 11 July 2014, in which the
practitioner was responding to Patient A's concern that the practitioner
had a conflict of interest in being involved in Patient A's surgery given his
commercial association with the TFS device, the practitioner informed the
Commission that he was no longer the beneficial patent owner of the TFS
device but failed to disclose that:
i. he only removed himself as a residuary beneficiary under the Petros Future Trust and resigned as a director of Sappho on 7 July 2014, that is:
almost three weeks after he received the letter outlining Patient A's concern on 18 June 2014; and only four days before his 11 July 2014 letter to the Commission; and
ii. his family members in any event continued to hold financial interests in the TFS device;
b. on 9 October 2015 the practitioner was issued with a Notice to Appear
under s34 of the Health Care Complaints Act 1993 (NSW) by the
Commission to appear before it in an interview. On 20 October 2015 the
practitioner was interviewed by the Commission. At the interview, the
practitioner told the Commission that he had divested himself of any
commercial interest in the TFS device but concealed or omitted to mention
his family members' ongoing financial interests in the TFS device;
c. the practitioner, through his lawyers, provided the Commission with a copy of the IPLD which was missing the page containing clause 10.2, which
clause provides that Kvinno is the sole and beneficial owner of the
Technology and the Intellectual Property in the TFS device. When asked
about the missing page, in a response dated 20 April 2016 the practitioner
stated that he could not conclude that the IPLD was missing a page;
d. at all times from about 11 July 2014 until August 2017 the practitioner failed to disclose in response to questions from the Commission the existence of the unsecured, interest accruing loan from the Petros Future Trust to TFS Manufacturing, which at all relevant times exceeded $700,000.
In the circumstances of particulars 8.a, 8.b, 8.c, and/or 8.d the practitioner furnished the Commission with information knowing that it was false and/or misleading.
In a letter sent to the Commission on 11 July 2014, the practitioner knowingly provided false and/or misleading information to the Commission in that he stated that he was "merely the assistant" in Patient A's surgery in circumstances where:
a. the practitioner knew that he was required by the hospital to supervise Dr Reid in the operation;
b. the operation involved the use of the TFS device;
c. the practitioner was responding to Patient A's complaint about the
practitioner's involvement in her surgery;
SUMMARY OF UNDISPUTED FACTS REGARDING THE TFS DEVICE
The practitioner
The practitioner was first registered to practise as a medical practitioner in NSW in 1964.
The practitioner was a Reconstructive Pelvic Floor Surgeon and a certified Urogynaecologist at all times relevant to this complaint.
The practitioner invented the TFS device.
The practitioner commenced working at The Sydney Private Hospital in Ashfield, New South Wales (the hospital) in May 2013.
The practitioner retired from practice in about November 2016.
The TFS Device
In 2002, the practitioner applied to the Therapeutic Goods Administration's (TGA) Australian Register of Therapeutic Goods (ARTG) for the registration of the "Petros Pelvic Ligament Anchor" (PPLA). The PPLA was included on the ARTG in around 2003 or 2004 and given ARTG No. 1326567
The sponsor of the PPLA was a company named Kvinno Centre Pty Ltd (Kvinno). Kvinno was originally registered in 1972. The practitioner was a director of Kvinno from 1972 to 2005. At all material times since 2005, the practitioner's wife (Patricia Petros) and son (Emanuel Petros) have been the directors of Kvinno.
In 2004, TFS Manufacturing Pty Ltd (TFS Manufacturing) was registered. The practitioner was the sole director of TFS Manufacturing from 2005 to July 2009. In July 2009, Mr Paul Zadow also become a director and has remained so to date. The practitioner resigned as a director on 19 July 2011.
In October 2006, TFS Manufacturing wrote to the TGA regarding its application for inclusion of a medical device on the ARTG known as the TFS. The ARTG number quoted was the same ARTG number given to the application made by the practitioner (and sponsored by Kvinno) in 2002 for the PPLA. By letter dated 31 October 2006, the TGA notified TFS Manufacturing that the TFS had been included on the ARTG.
At all times since 2006, TFS Manufacturing has been the sole manufacturer of the TFS device worldwide.
Ownership of the TFS device technology and intellectual property
On or about 1 November 2008, an "Intellectual Property Licence Deed" (IPLD) was signed by Kvinno (the "licensor"), TFS Manufacturing (the "licensee") and Mr Paul Zadow and Mrs Robyn Zadow as Trustees for the Zadow Family Trust.
By Clause 2.1 of the IPLD, Kvinno granted to TFS Manufacturing "a fee-free, royalty-free, sole and exclusive license to use, exploit and commercialise the Technology and Intellectual Property…"
The IPLD defines "Technology" and "Intellectual Property" to mean, in effect, the TFS device and its implementation (including any improvements or modifications).
Clause 8 of the IPLD provides that if Kvinno sells the Intellectual Property, it is entitled to at least 75% of those proceeds, and 100% of the proceeds if Mr Zadow is not a shareholder of TFS Manufacturing at the time of the sale.
By Clause 10.2 of the IPLD, Kvinno warranted to TFS Manufacturing that Kvinno "has all necessary right and title to grant the License; and (b) it is the sole and beneficial owner of the Technology and the Intellectual Property."
The Petros Future Trust
The shares in Kvinno are 100% owned by Sappho Pty Ltd (Sappho).
Sappho was registered in 1976. The practitioner was a director of Sappho from 1976 until 7 July 2014. At all times since 7 July 2014, the practitioner's wife (Patricia Petros) and son (Emanuel Petros) have been the directors of Sappho.
Sappho holds the shares in Kvinno on trust for the Petros Future Trust.
The Petros Future Trust was established on 1 April 2005. Relevantly:
from 2005 until 7 July 2014, the practitioner was a "residuary beneficiary" of the Petros Future Trust;
the practitioner's wife (Patricia Petros) is, and at all material times has been, a "residuary beneficiary" of the Petros Future Trust;
three of the practitioner's children and grandchildren are, and at all material times have been, "primary beneficiaries" of the Petros Future Trust; and
on 7 July 2014, the practitioner retired as guardian and appointer of the Petros Future Trust and was replaced by his wife (Patricia Petros) and son (Emanuel Petros).
Loans from the Petros Future Trust to TFS Manufacturing
In or about September 2009, the Petros Future Trust made a loan of $62,000 to TFS Manufacturing. The loan was repaid on 21 September 2014. The total interest earned in that period was $12,078.40.
For the financial year ending 30 June 2014, the Petros Future Trust had on its balance sheet an unsecured loan in the amount of $732,282 to TFS Manufacturing and accrued interest on that loan in the amount of $129,633.
For the financial year ending 30 June 2015, the Petros Future Trust had on its balance sheet an unsecured loan in the amount of $728,623 to TFS Manufacturing and accrued interest on that loan in the amount of $157,354.
For the financial year ending 30 June 2016, the Petros Future Trust had on its balance sheet an unsecured loan in the amount of $1,488,623 to TFS Manufacturing and accrued interest on that loan in the amount of $183,281.
DR PETROS' REPLY
Interests of Dr Petros – the period September 2009 to 7 July 2014
Dr Petros admits that he, as a residuary beneficiary of the Petros Future Trust, had the following financial interests in the TFS device:
the Petros Future Trust was the beneficial owner of 100% of the shares in Kvinno, which in turn owned the technology and intellectual property in the TFS device (Financial Interest 1); and
the Petros Future Trust, through its 100% beneficial ownership of the shares in Kvinno, was entitled to at least 75%, and up to 100%, of the proceeds of any sale by Kvinno of the intellectual property in the TFS device (Financial Interest 2).
Dr Petros: admits the existence of the loans, and accrued interest owing, from the Petros Future Trust to TFS Manufacturing (described above at paragraphs T to W);
denies that the loans and accrued interest constituted a financial interest for the Trust or himself in the TFS device (Financial Interest 3).
Interests of Dr Petros' family members – the period September 2009 to date
Dr Petros admits that his wife, son and grandchildren were beneficiaries of the Petros Family Trust but denies that his wife, son or grandchildren have had any of the following financial interests in the TFS device:
the Petros Future Trust was the beneficial owner, through its 100% beneficial ownership of the shares in Kvinno, of the technology and intellectual property in the TFS device (Financial Interest 1);
the Petros Future Trust, through its 100% beneficial ownership of the shares in Kvinno, was entitled to at least 75%, and up to 100%, of the proceeds of any sale by Kvinno of the intellectual property in the TFS device (Financial Interest 2);
the Petros Future Trust had a financial interest in the TFS device through the loans it made and the interest it charged to TFS Manufacturing (Financial Interest 3).
Evidence relating to Complaint One
1. The respondent came to notice following a complaint made by a patient which was received by the applicant on or about 2 June 2014. The patient, Patient A, complained to the applicant about her surgery conducted by Dr Reid at which Dr Petros was present. The patient complained that Dr Petros failed to indicate to her that he had a financial interest in the device which was inserted into her during the operation.
2. By letter dated 18 June 2014 the applicant wrote to Dr Petros informing him of the complaint. A copy of the complaint was attached to the letter. The letter stated:
"The Commission is required to assess this complaint within 60 days and invites you to provide your written response and records by Thursday, 10 July 2014."
1. Simultaneously, a letter in the same terms was sent to Dr Reid. Dr Reid was the surgeon performing the surgeries which several patients referred to in the Complaint at the Sydney Private Hospital.
2. An email chain has been tendered. On 20 June 2014 the respondent sent an email to Dr Reid stating relevantly:
"Some problems but we-should be able to mollify many of them will stop when did you go to Europe? Let's discuss specific points in a.m."
1. On 19 June 2014 a diary note records that the respondent telephoned the Medical Council to enquire about the complaint. Relevantly the respondent stated that he was only an assistant in surgery.
2. The respondent replied by email on 11 July concerning the allegations made against him. In such email he relevantly stated:
"Although I am a medical researcher, I am a Current Fellow of the British and Australian Colleges of Gynaecology and a practising surgeon. My presence in an operating theatre should not in any way be considered unusual…
With regard to my alleged conflict of interest I was not the decision maker in any of Patient A's operations. I was merely the assistant. As such, there could not possibly be a direct conflict of interest in being involved in Patient A's operations. However, I am happy to answer the questions posed.
a. I am the registered inventor of the TFS.
b. I am no longer the beneficial patent owner of the TFS device and therefore I do not receive a royalty from its implantation
c. I am gratified by the success of this procedure worldwide, especially as it stems from my initial theories.
d. As the inventor of TFS, it goes without saying that I would have been the original owner of the TFS.
e. I am a public speaker at many conferences, some of which will be sponsored by the TFS company in conjunction with many other device and pharmaceutical companies. At no time have I ever received any form of financial remuneration from any company from speaking at meetings about TFS or any other product.
f. I am pleased to be considered as a leading medical researcher in TFS.
6. As a surgeon, with significant experience with this procedure, who is accredited at The Sydney Private Hospital, it would not be considered unusual to be asked to assist in these cases at that hospital.
As far as I am aware, Patient A has not been entered into a clinical study for medical research purposes.
In particular,
a. I cannot comment on any changes that may have been made to the operating note in my absence.
b. Patient A was booked for surgery by Professor Reid and I was asked to provide assistance. Any machinations regarding changes of date are beyond my knowledge.
Further investigation
1. The applicant wrote to the respondent on 17 June 2015 relevantly stating:
On 11 June 2015 the Commission consulted with the Medical Council of NSW regarding new allegations to be added to the investigation.
Under s20A of the Act, the Commission has added the following specific allegations to the investigation of the complaint:
That you have breached section 99 of the Act by providing false and misleading information to the Commission. In your response to the Commission on 11 July 2014 you stated that you were no longer the beneficial patent owner of the Tissue Fixation System (TFS) device. However research carried out by the Commission in November 2014 found that you are a 50% shareholder in Sappho Pty Ltd, which holds 100% of the A class shares in KVINNO CENTRE PTY LTD. The registration of TFS and ownership of the patent is attributed to KVINNO CENTRE PTY LTD. This makes you a beneficial patent owner of the TFS device.
That you have an ethical obligation to disclose your pecuniary interest in the TFS device, and failed to do so, to 113 patients whose surgeries you were involved in at The Sydney Private Hospital as the Surgical Assistant. The attached Excel spreadsheets A and B list these patients.
That in the two surgeries where you were the Surgeon at The Sydney Private Hospital, you acted in contravention of section 139B(i) of the Health Practitioner National Regulation Law (NSW) 2009 (the National Law (NSW)) as you did not disclose the nature of your interest in the TFS device to these patients before or at the time of surgery. The attached Excel spreadsheet C lists these patients.
That in one consultation with a patient on 30 October 2013 where you were the consulting doctor, you acted in contravention of section 139B(i) of the National Law (NSW) as you did not disclose the nature of your interest in the TFS device to her.
That from 5 November 2014, you had knowledge that the TFS device and its implementation was removed from the Australian Register of Therapeutic Goods, and you failed to disclose this information to those patients whose surgeries involved the TFS device, and that you were involved in, following this date. The attached Excel spreadsheet D lists these patients.
That you were present as a Surgeon or Surgical Assistant to Dr Reid, Dr Gold and Dr Ende, for the purposes of either:
training these doctors in the implementation and use of the TFS device, in which you have a pecuniary interest; and/or
for the purpose of obtaining clinical data.
1. By letter dated 3 August 2015 the lawyers for the respondent replied stating relevantly:
3. Dr Petros denies that he provided any false or misleading information to the
Commission. In his response of 11 July 2014, Dr Petros specifically stated:
(a) I am the registered inventor of the TFS.
(b) I am no longer the beneficial patent owner of the TFS device and therefore I do not receive a royalty from its implantation.
(c) I am no longer the beneficial patient owner of the TFS device and therefore I do not receive a royalty from its implantation.
(d) I am gratified by the success of this procedure worldwide, especially j as it stems from my Initial theories.
(e) As inventor of the TFS, it goes without saying that I would have been the original owner of the TFS. I am a public speaker at many conferences, some of which will be sponsored by the TFS company in conjunction with many other device and pharmaceutical companies. At no time have I ever received any form of financial remuneration from any company from speaking at meetings about TFS or any other product.
(f) I am pleased to be considered a leading medical researcher in TFS.
4. It is our understanding that the Commission considers point (b) above both false and misleading. In order to respond to this allegation we have conducted a number of ASIC searches, obtained information from Mr Paul Zadow, the Managing Director of TFS Surgical as well as the accountant for Dr Petros.
1. With regard to the Intellectual Property Licence Deed, the letter stated:
Kvinno and TFS entered into an Intellectual Property Licence Deed (the Deed) which commenced 1 November 2008. Please find attached an email from Mr Paul Zadow of TFS Manufacturing dated 23 July 2015 providing a summary of the Deed. Importantly, Kvinno granted TFS, royalty-free, sole and exclusive licence to use, exploit and commercialise the Technology and Intellectual Property". The Deed remains current. Dr Petros has been unable to locate a copy of the Deed. If the Commission requires a copy, we suggest that the request be directed to Mr Zadow.
1. As to the ownership of the patent, such letter stated:
"Further, we are instructed that any benefit flowing from ownership of the Patent (by Kvinno) was passed by Kvinno to TFS Manufacturing under the Deed which commenced 1 November 2008. It is our understanding that in November 2008 IVS transferred the shares in TFS Manufacturing to Sappho and in July 2011 Sappho transferred the shares to TFS Manufacturing. So the last shareholding in TFS Manufacturing associated with Dr Petros (Sappho) was in July 2011."
Expert Evidence
Professor Paul Komesaroff
1. Professor Komesaroff provided two reports to the HCCC. In his report of 30 August 2016 he made comment upon the question whether the respondent should have disclosed his financial interest in the device to the patient.
2. Professor Komesaroff stated that such information should have been disclosed to the patient. He wrote:
The patients were entitled to know of Dr Petros' interests because this information was potentially relevant to the decisions which they were being called upon to make. Dr Petros should have taken steps to assure himself that the appropriate disclosures had been made known to them. He was not himself obliged to tell them personally. In other words, Dr Petros was ethically obliged to have taken reasonable steps to ensure that the patients were adequately and appropriately informed about his interests.
1. Another question was asked of Professor Komesaroff as follows:
Assuming that Dr Petros and/or his family had not divested their financial interest in the TFS device at the relevant time, please provide your opinion of Dr Petros performing the TFS surgery for a patient on 4 June 2013, and the two known surgeries on 28 March 2014 and 28 October 2014, in circumstances where these patients were not aware prior to surgery that Dr Petros would be the principal surgeon.
1. Professor Komesaroff relevantly responded:
"As has been stated, Dr Petros was ethically obliged to ensure that the patients in whose care he was participating, were informed of the interests of his which may have affected their decisions about surgery."
1. The role of the respondent in surgery, as supervisor was then considered by Professor Komesaroff. He stated:
Even if Dr Petros did have a relevant relationship with Dr Reid's patients, his primary relationship in this context was with Dr Reid. If he was acting as the "director, supervisor and trainer" of Dr Reid he was reasonably obliged to assure himself that Dr Reid was following his advice. However, it would not be assumed that in this case Dr Petros would be involved in, or take responsibility for, all the decisions taken by Dr Reid.
Accordingly, I do not think that Dr Petros' and Dr Reid's responsibility for patient selection and suitability should be regarded as either "equivalent" or "equal".
1. With respect to the surgeries on 28 March 2014 and 28 October 2014 during which Dr Gold decided he was insufficiently experienced to deal with the issues arising during the surgery and requested Dr Petros, the assistant surgeon, to take over. Professor Komesaroff said:
If Dr Petros had in fact returned to the patients under these circumstances as the principal surgeon he would have incurred a direct responsibility to ensure that the consent process was conducted appropriately, including that all relevant disclosures were made. In such cases, Dr Petros should have conducted the discussions with the patients himself. In rare circumstances, consent for surgery may be obtained by another practitioner, although here responsibility for the consent and the disclosures under these circumstances still remains with the principal surgeon.
1. Professor Komesaroff was asked:
Please provide your opinion of Dr Petros' conduct in receiving payment as Dr Reid's surgical assistant in operations in which the TFS device was implanted or removed in circumstances where:
He did not disclose that he was required by Sydney Private to 'direct, supervise and train' Dr Reid in the use of this new style of surgical procedure; and he did not disclose his or his family's interests in the TFS device.
1. Professor Komesaroff responded:
As mentioned, it was Dr Petros' responsibility to assure himself that all proper and relevant disclosures had been made to the patient and that consent had been properly obtained. It was appropriate for conversations in relation to consent to have been conducted by the principal surgeon, who should have disclosed to the patient the dual roles of Dr Petros as an assistant and as the inventor and benefactor of the device.
Notwithstanding these obligations, Dr Petros was entitled to receive payment for his work as an assistant if he actually performed the work of an assistant.
Cancellation of Registration
1. Following the cancellation of the registration of the TFS device by the ARTG, the respondent continued to use the device when he knew it was cancelled and further that the patients were not informed of its cancellation. Professor Komesaroff was asked to provide his opinion of such conduct.
2. Professor Komesaroff said:
In view of the fact that Dr Petros himself had both direct (pecuniary) and indirect (non-pecuniary) interests in the supply of the device he should have been especially punctilious about his obligations in this regard. In particular, he was under an ethical obligation to ensure that full disclosure of the circumstances had been made to the relevant parties, including the patient, his colleagues and the hospital. The disclosure to the patient—which Dr Petros had a responsibility to assure himself had been made—should have included: (i) a statement that the product had been discontinued from the ARTG, including the ARTG's reasons; (ii) a statement about his reasons for disagreeing with or contesting the ARTG's decisions and an explanation of why he felt that it was still appropriate to continue using the product; and (iii) a statement about his own direct and indirect interests in the device.
In summary, it was not inherently inappropriate from an ethical point of view for Dr Petros to have continued to participate in TFS surgery after the device had been cancelled from the ARTG. However, under such circumstances he was under a strong obligation to ensure that the patients who received the device were properly advised of the circumstances and had given explicit consent for the operation to proceed.
Professor Komesaroff was asked about the fact that he travelled with another patient in an ambulance to hand over that her care to doctors at St George Hospital and failed to properly advises doctors of the nature of the surgery she underwent namely TFS; the fact that this was the first time that the principal surgeon had carried out the surgery and that he had been present in his capacity as "director, supervisor and trainer" of the surgery.
Divesting of Interest
1. Professor Komesaroff was also asked questions relating to the financial transactions involving the respondent wherein he divested himself of a directorship of Sappho and excluded himself as beneficiary of the Petros Future Trust; transferred his directorship of Sappho to his wife and son; nominated his wife and son as guardian and appointor of the Petros Future Trust and retained his wife as a residuary beneficiary of the Petros Future Trust.
2. Professor Komesaroff stated:
The ethical concept of "interest" refers to a commitment, goal, value or duty associated with a particular social relationship or practice. Formal legal obligations may be taken into account but they are only one aspect of the concept. Assuming that Dr Petros maintained a cordial relationship with his wife and son, the transfer of roles and responsibilities to them would not obviously diminish either his pecuniary or non-pecuniary interests in the affairs of the companies referred to.
If the assumptions of the question are valid, there would seem to be a justifiable inference that Dr Petros undertook the actions described in order to be able to claim that his association with the companies did not entail an interest that needed to be disclosed. However, as just mentioned, such a claim would not have been justified because the interests would have perdured in spite of the formal adjustments in the relationships.
If it were in fact the case that Dr Petros had undertaken actions that were intended to avoid his obligation to disclose his interests, or other responsibilities, that would have been ethically unconscionable.
1. In his second report Professor Komesaroff provided further opinions concerning the necessity to inform his patients of the financial interest (as well as non-financial interest) that could have affected the decisions which they made concerning the proposed surgery. In particular, he stated that the respondent had an obligation to inform patients directly of the cancellation of the TFS device by the ARTG or to satisfy himself that the primary surgeon had done so.
2. As to the claimed concealing from the applicant of the arrangements concerning ownership of the TFS device, Professor Komesaroff drew attention to the requirements of the Code of Conduct for medical practitioners on disclosure of interests to patients. The Code relevantly provides:
Doctors must be honest and transparent in financial arrangements with patients. Good medical practice involves:
8.12.1 Not exploiting patients' vulnerability or lack of medical knowledge when providing or recommending treatment or services.
8.12.2. Not encouraging patients to give, lend or bequeath money or gifts that will benefit you directly or indirectly.
8.12.3 Avoiding financial involvement, such as loans and investment schemes, with patients.
8.12.4 Not pressuring patients or their families to make donations to other people or organisations.
8.12.5 Being transparent in financial/and commercial matters relating to work:
8.12.6 including your dealings with, employers, insurers and other organisations or individuals. In particular:
8.12.7 declaring any relevant and material financial or commercial interest that you or your family might have in any aspect of the patient's care
8.12.8 declaring to your patients your professional and financial interest in any product you might endorse or sell from your practice, and not making an unjustifiable profit from the sale or endorsement.
1. Professor Komesaroff also referred to the Guidelines of the Royal Australian College of Surgeons which relevantly states:
3.3 Conflict of Interest/perceptions of bias
Individuals should declare to the hospital/health service decision-making body any involvement in prior assessment of the procedure and any financial involvement that could result in a conflict of interest.
Doctor Geraghty
1. Dr Geraghty, a specialist gynaecologist of almost 40 years' experience and former head of the Department of the Maternity Services at Dubbo base hospital, provided a report. In his report he stated as follows:
Disclosure
2. In respect of the financial interest of the respondent Dr Geraghty stated that as the inventor, promoter and having a financial interest in TFS, the respondent was obliged to inform any patient and his director indirect care of such facts prior to a procedure being informed. Further, he was obliged to inform patients of his Association with the TFS device even if he was directing, supervising and assisting the primary surgeon in such surgery. Such instruction should have been given through the other surgeons Dr Petros was under an obligation to inform the primary surgeon of such interests.
3. Dr Geraghty opined that failure to disclose would constitute a breach of the Medical Boards Code of Conduct, clauses 8.11 8.12) or the RACS code of conduct at 8.1 (4).
4. The obligation to disclose the use of the TFS device to the patient continued if further surgery was to be carried out and the TFS device was to be used. Such duty of disclosure arose because of the financial interest in the respondent's family interest in the TFS device. That is, he should have made it clear to both the primary surgeons and to the patients of his direct and indirect interest in the device. Failure to disclose would be unethical conduct in view of the requirements of the Code and of the RACS code. In particular, he should have ensure that Dr Gold was well aware of the direct and indirect interest which the respondent had in the device.
5. The duty of disclosure extended to the respondent being obliged to make the disclosure to the owner of the Sydney Private Hospital and failure to do so constituted unethical conduct. Further, when the respondent agreed with the Sydney Private Hospital to supervise Dr Reid in 2013, the respondent was obliged to disclose his, or that of his family's interest in the TFS device, to the hospital. Failure to do so would be unethical.
6. Following the cancellation of the TFS device from the ATGR register shortly after 5 November 2014 (the date such cancellation took effect) and on the basis that the respondent was continuing to use such device, he was obliged to inform patients directly or through the primary surgeon of the removal of the device from such register before it was used in procedures. Patients should have been made aware of such removal. The pecuniary interest which is held by the respondent in continuing to use such device, without such disclosure, would constitute unethical conduct.
Dr Anthony Eyers
1. Dr Eyers is a colorectal surgeon who provided a report dated 24 March 2019 for the respondent concerning ethical conduct and principles.
2. Dr Eyers stated that on his understanding, the respondent had no direct financial interest in the TFS device in March 2013 and had no direct financial benefit from it since 2008; he did however have a potential indirect financial interest by virtue of his family standing to benefit from the future favourable sale of his IP rights.
3. Dr Eyers stated that having an interest does not, per se, result in conflict; in the present situation, the most obvious conflict would be a concern that the respondent's financial or reputational interest in the TFS device would influence his selection of patients to have the TFS device used in their surgery. However, Dr Eyers notes that the case selection in these instances was left entirely to Dr Reid and Dr Gold and that therefore it was impossible for any financial interest that the respondent might have had to influence the patient selection process.
4. From the materials provided to him, Dr Eyers stated that the respondent did not believe he was in a conflicted position as he had no influence on the patient selection process.
5. As to the issue of supervision, Dr Eyers stated that to have the respondent, an experienced surgeon, assisting in a procedure would have been helpful. The MAC of the hospital was clearly seeking to provide assistance to Dr Reid and the presence of Dr Petros was appropriate.
6. Generally, Dr Eyers agreed with the observations of Professor Komesaroff but he did not necessarily accept some of the assumptions made in his report. He maintains that the patients who were being treated by Dr Reid should be regarded as those of Dr Reid and that they were not those of the respondent.
7. As to the reasonable expectations of disclosure, Dr Eyers said that he would find it difficult to accept "that surgeons who invent surgical prostheses should reasonably be expected to entirely divest themselves of any potential long-term financial benefit deriving from the future sale of their IP." He observed that in the present circumstances all the practitioner's financial interest has been divested, accepting his potential interest in the future favourable sale of the IP.
8. In cross examination Dr Eyers agreed that a patient could not give informed consent in respect of the use of the TFS unless Dr Reid had discussed with him that the respondent had a financial interest in the TFS device; if Dr Reid was uninformed about such matter, there was no informed consent from the patient. Further, Dr Eyers considered that once the registration on the ATGR had been cancelled, this fact should have been disclosed to the patients. If the assistant surgeon had a financial interest in the TFS, this was required to be disclosed to the patient. The patient needs to know that the assistant is the inventor and may have a financial interest in the product.
Dr Darren Gold
1. Dr Darren Gold is a specialist colorectal surgeon who has an interest in proctology and pelvic floor disorders.
2. Dr Gold said that he was aware that the respondent was the inventor of TFS and had been provided with a copy of the respondent's book entitled "The Female Pelvic Floor" which he had read. Subsequently, Dr Gold performed in consultation, many surgical operations involving the use of the TFS device with the practitioner. On two occasions, during surgeries, Dr Gold asked Dr Petros to take over as he found that they were particularly complicated cases.
3. Dr Gold said he had a professional relationship with the respondent, and spent hundreds of hours with him learning about anatomy, the mechanics and other detail aspects relating to female prolapse, the 'Integral Theory', and the utilisation of the TFS.
4. Dr Gold conducted operations at the Sydney Private Hospital from 2014 using the TFS. He stated that he provided each patient with thorough details in relation to the manner of the surgery, the use of the TFS and material risks. During this period the respondent acted as a consultant to Dr Gold, and Dr Gold would discuss certain aspects of the patient's symptoms with the respondent and seek his explanation. At all times Dr Gold was the lead surgeon and it was his decision, with the consent of the patient, to use the TFS.
5. Dr Gold recalled that the respondent was specifically arranged to participate in consultations prior to surgery in respect of certain patients. One patient, Ms JR specifically requested that the respondent operate upon her view of the very successful outcome for her friend, the second patient, NS in a particularly complicated medical presentation including multiple failed operations and almost constant incontinence. The respondent was engaged by Dr Gold to consult on these particular cases.
6. In late 2014 Dr Gold was informed that the TFS was no longer registered on the ARTG. He considered that the product was an excellent one, and decided to conduct his own investigations. He spoke to Paul Zadow who was the CEO of TFS Manufacturing and also spoke to that company's solicitors. Dr Gold states:
7. "I was informed that Professor Petros was not receiving any financial benefit from the TFS and that he had no financial interest in the company."
8. Dr Gold also stated that he did not discuss with the respondent his family interests in the TFS and there was no discussion on the subject. He was unaware of any financial interest of the respondent in the TFS.
9. Dr Gold states that the respondent was simply an advisor or consultant to him in relation to the general application of the TFS device based upon the Integral Theory and was not consulting directly with patients.
10. In his supplementary statement dated 3 April 2019 Dr Gold states, that following the removal of the TFS registration, he informed all his patients for whom he intended to use the TFS device that it was no longer registered on the ARTG, even though a supply of such devices were held by the hospital.
11. Annexed to the statement of Dr Gold are notes of a telephone conversation held between Dr Gold and the solicitors for TFS. It disclosed that Dr Gold told was told:
1. TFS Manufacturing Pty Limited was owned by two shareholders.
2. The first shareholder was Paul Zadow and Robyn Zadow (jointly) for 25%.
3. The second shareholder was TFS Manufacturing Holdings Pty Limited ACN 152 234 056 for 75%.
4. TFS Manufacturing Holdings Pty Limited has one shareholder. That shareholder is Paul Zadow
The Respondent's Statements
1. The respondent has provided a statement dated 19 February 2019 and also during the hearing provided an additional statement. The respondent provides the following information concerning his status:
Experience as a Surgeon:
I am a retired Urogynecologist. I no longer hold a registration as a medical practitioner with the Australian Health Practitioner Regulation Agency.
Prior to retirement, I worked as a reconstructive pelvic floor surgeon. I was registered in New South Wales in 1964. I was registered with the Australian Health Practitioner Regulation Agency in the specialist category of Obstetrics and Gynaecology and the specialty field of Urogynaecology. I am a certified as Urogynecologist and Reconstructive Pelvic Floor Surgeon with The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.
Between 1977 and 1983, I trained at the Royal Hospital for Women in Sydney and practiced in Sydney. I then relocated to Perth where I practiced [sic] as in Obstetrics and Gynaecology with a subspecialty of Urogynaecology and Reconstructive Pelvic Floor Surgery.
In addition to my clinical practice, I have also worked on the following:
a. further education: PhD (University of Uppsala), DS (University of WA),MD (University of Sydney) and DSc (University of WA);
b. teaching (medical students, registrars, JRMOs in O+G);
c. academic appointments;
d. research and publishing articles for peer review journals;
e. reviewing articles for peer review journals; and
f. research and inventions;
g. supervision of Honours, Masters and PhD students
TFS Device
1. The respondent provided the following information in his statement concerning the device:
When I moved to Perth, I began research into the cause of female stress incontinence. By the late 1990's I co-developed the Midurethral Sling with the late Professor Ulmsten from the University of Uppsala. I also developed what is commonly referred to as the 'Integral Theory System'. This led to the development of the TFS device.
In 2002, I applied to register the "Petros Pelvic Ligament Anchor" on the Australian Register of Therapeutic Goods. The sponsor was Kvinno. It was included around 2003 or 2004.
By 2003, I had developed the Tissue Fixation System ("TFS") device, The TFS device was the first 'mini-sling'.
At about this time, a Federal Government Grant for this research was sought. I was advised that a corporate entity should apply for the grant.
History of the Financial Interest of the Respondent in TFS
1. The respondent provided the following information concerning the creation of the financial arrangements concerning the ongoing use of the TFS:
In May 2004, TFS Manufacturing was set up to manufacture and supply the TFS device. I received a director's salary with TFS Manufacturing for the financial years 2010 to 2012. I received no salary after financial years 2011/2012. Sappho previously held ordinary shares (not beneficially held) in TFS Manufacturing. IVS held ordinary shares (beneficially held) in TFS Manufacturing. In November 2008, IVS divested itself of the shares in TFS Manufacturing to Sappho. In July 2011, Sappho divested the shares.
Disclosure of Financial Interest
1. The respondent provided the following evidence:
I was and am aware of disclosure obligations on medical practitioners relating to relevant interests arising from medical devices. The disclosure also extends to publications in scientific journals. In relation to the TFS device, I attach a schedule of articles marked with the letter "A", setting out the terms of the disclosure.
I advised the surgeons who used the TFS device, such as Dr Richard Reid ("Dr Reid") and Dr Darren Gold ("Dr Gold"), that I invented the device and I gave them copies of my publication "The Female Pelvic Floor" (Springer-Verlag, 3rd ed 2010). Furthermore, all my surgical papers, which include conflict of interest disclosures, are required reading for any surgeon learning to use the TFS device.
After November 2008, I believed that neither l nor my family or any related entities held a financial interest in the TFS device and did not receive any financial benefit from it.
From July 2011, I was no longer a director of TFS Manufacturing. Paul Zadow was the sole director. I understand that Paul Zadow advised relevant surgeons who used the TFS device that from 2011, he (as director of TFS Manufacturing) had control of the device.
In or around November 2014, I was notified that the TFS device was no longer registered with the ARTG. I recall receiving this information from Paul Zadow of TFS Manufacturing. I discussed that development with Dr Gold and Dr Ende at the time. I was under the understanding that TFS Manufacturing conveyed the relevant information to surgeons using the device and this would have included Dr Gold.
At this time, I was not the lead surgeon on any procedures involving the TFS device. I was aware that Dr Gold, who was the lead surgeon of procedures in which I assisted, knew of the registration issue at the time of these surgeries and I am aware that he had communicated all relevant information about the TFS device to each of his patients. I did not consider it necessary for me to also notify these patients that I was its inventor
Disclosure to Applicant
1. On 3 November 2016 the respondent prepared an extensive response under section 40 the Health Care Complaints Act 1993. The response was compiled with the assistance of his solicitor. In such statement the applicant relevantly stated:
"Having considered the matter further (and having asked my accountant to consider the financial interest point more broadly), I can see the argument that I did have a "financial interest" in the TFS device as at March 2013."
1. Later in the same statement the respondent stated:
When I was answering questions about TFS Manufacturing at the interview my focus was on the accusation that I had a financial interest in that I was in receipt of royalties. I accept my narrow focus resulted in narrow answers and as explained above, I do have an ongoing interest in TFS Manufacturing. My "interest" can be summarised as follows:
a. I invented the device that it manufactures. I consider this to bethe only device that effectively repairs all 5 pelvic ligaments.This could change in the near future as I am aware of othermanufacturers on the cusp of marketing comparable productsand I welcome all forms of improvement to any device(irrespective of the manufacturer) that delivers better healthoutcomes for women who suffer incontinence.
b. I invested money into TFS Manufacturing in the early period(seed capital). There was also the loan from the Petros FutureTrust to TFS Manufacturing in 2009 which has been repaid infull.
c. I remain good friends with Paul Zadow.
…
Having considered the matter further (and having asked my accountant to consider the financial interest point more broadly), I can see the argument that I did have a "financial interest'" in the TFS device as at March 2013. I have sought advice from my accountant to answer questions put to me by the Commission over the past few years. I have attached a letter from my accountant. Alex Hew of Blyth Partners, dated 19 February 2016 summarising the information that had been provided to me (Attachment H). I have also attached an email exchange between my lawyer and Mr Hew seeking clarification around the financial interest point (Attachment I). You will note the most recent email explains that the Petros Future Trust loaned $62,000 to TFS Manufacturing in September 2009. This capital sum was repaid on 21 September 2014. The total interest earned was $ 12,078.40.
Understanding of 'interest now'
The Commission's investigation has focused my mind on real and perceived conflict and I have benefitted greatly from reading the expert opinion. The expert is clearly comfortable characterising different forms of conflict and the steps that should be taken to disclose that conflict and to whom (which will vary based on the circumstances). I accept my level of knowledge in this area as not as deep and wide as that of the expert (who is clearly an expert in medical ethics).
Respondent's Accountant
1. Mr Alex Hew has been the respondent's accountant for more than 15 years. Mr Hew practises from Perth. He provided a statement and also provided oral evidence by telephone. He stated that in 2012, his firm, Blyth Partners commenced the process of ascertaining the implication of a taxation decision in respect of their client's needs. On 4 March 2014 he wrote to the Petros Future Trust advising it of the need to change its Trust Deed.
2. On 7 July 2014, it was proposed that the following changes be made to the Trust, by way of Deed of Variation:
1. effecting the resignation of Peter Emanuel Petros as guardian and appointor;
2. effecting the appointment of Patricia Margaret Petros and Emanuel Petros as guardians and appointors, acting jointly;
3. removing Peter Emanuel Petros as a beneficiary of the Trust;
4. replacing outdated or deficient provisions (or parts of provisions); and
5. inserting additional provisions which are essential for tax law, trust law and administrative purposes.
1. Mr Hew stated that none of the changes referred to above resulted from any complaint from the HCCC and that the changes were made entirely independently. He was unaware that any complaint had been made by the HCCC. The Tribunal notes however, as set out in its findings, that Mr Hew acknowledged that the practitioner's cessation of directorship in Sappho and removal of himself as beneficiary were unrelated to the taxation decision of the High Court.
Complaint One Findings
1. In making its findings in respect of each complaint, the Tribunal notes that it will take into consideration the gravity of the allegations contained in the complaints in assessing its determination whether the allegations are established. Generally, it will apply the evidentiary burden referred to in Briginshaw v Briginshaw [1938] HCA 34; (1938) 60 CLR 336 at 362-363. However, the Tribunal notes the observations of Hayne J in FTZK and Minister for Immigration and Border Protection [2014] HCA 26 (27 June 2014) that it is a misnomer to speak of a "standard of proof" outside the adversarial processes of a court: see [34]. This Tribunal sees no conflict where it is acknowledged that generally, the principles in Briginshaw are the most appropriate guide to the determination of the issues before it.
Particulars 1 and 2
1. The Respondent acknowledges the particulars concerning the establishment of the Petros Future Trust and of its financial interest in the TFS device as alleged in Particular 1. Secondly the respondent acknowledges that the Petros Future Trust was the beneficial owner, because of its 100% beneficial ownership of the shares in Kvinno of the technology and intellectual property in the TFS device; and that the Trust had a financial interest in the TFS device through the loans it made to TFS manufacturing.
Particular 3
1. The respondent admits that he knew or ought to have known that the TFS device was going to be used in hospitals and surgeries in which he would be operating; that the hospital could only purchase TFS device from TFS manufacturing; that he knew or ought to have known that he and members of his family had a financial interest in the TFS device. Further, he admits that the financial interest in the TFS device held by the practitioner and members of his family were relevant and material financial interest for the purpose of section 8.11 and 8.12.5 of the Code of Conduct.
2. The practitioner acknowledged that he failed to disclose any, or alternatively sufficient information concerning his family member's financial interest in the TFS device to the hospitals' MAC when agreeing, in May 2013, to supervise, mentor and assist Dr Richard Reid in the circumstances where the practitioner knew that the procedure to be adopted by Dr Reid would largely use TFS device; that Dr Reid was interested in the TFS to device and intended to use it in his surgeries in the future; that he would be supervising Dr Reid for three months and possibly longer depending upon Dr Reid's performance including the use of the TFS device.
3. The Tribunal finds particulars 1, 2 and 3 are proved.
Particular 4
1. The Tribunal finds that the practitioner did not disclose his interest in the TFS device to the MAC of the TSPH when the practitioner applied for accreditation in May 2013.
Particular 5
1. The respondent acknowledges that in respect of the 108 patients and surgeries listed in Annexure A to the complaint prior to the undergoing of surgery involving the TFS device, he failed to disclose to the patient any, or alternatively sufficient information about his or his family members financial interest in the TFS device or to ensure that the lead surgeon was aware of his and his family's financial interests in the device.
Particular 6
1. In respect of the two patients listed in Annexure B to the Complaint, the Tribunal finds that the respondent failed to disclose to the patient information about his family's members financial interests in the TFS device or ensure that the lead surgeon was made aware of his and his family's financial interests in circumstances where he was aware there is a possibility that he would lead the surgeon during the surgery; the respondent consulted with the lead surgeon and the patient prior to the surgery.
Particular 7
1. The respondent denied that he was under any obligation to inform patient in the terms set out in the particular.
2. The Tribunal finds that the practitioner was under an obligation to disclose the fact of the cancellation of the TFS device on the ARTG register or ensure that the lead surgeon had informed the patients that the TFS device registration had been cancelled from the ATRG register; the reasons for such removal of the device; and alternative approaches to surgery. Further the respondent was obliged to disclose the financial interest of the practitioner referred to and further to disclose the fact that the device could only be purchased from TFS manufacturing. The financial interest in TFS Manufacturing through loans made by the Petros Future Trust through the trustee Sappho, of which the respondent was a director and 50% shareholder until 7 July 2014 should have been disclosed.
Particular 8
1. The respondent denies that he gave misleading information to the applicant and/or made material omissions in his communications with the HCCC concerning his and his family's financial interest in the TFS device. The respondent further claims that he was removed as a beneficiary of the Petros Future Trust in response to financial planning advice; that at the interview which is held with the applicant he was not asked about his family members ongoing financial interest in the TFS device; that the page containing clause 10.2 which provided that Kvinno was a sole and beneficial owner of the technology and intellectual property in the TFS device was missing as a result of a clerical error. Lastly, the respondent says that at no time that he intended mislead the commission concerning his financial interests.
2. The Tribunal notes the evidence that on 11 July 2014 the practitioner stated that he was "no longer" the beneficial owner or the Patent on the TFS device. In answer to a further query of the applicant contained in a letter dated 17 June 2015, the practitioner's lawyers wrote to the applicant by letter date 3 August 2015. Such letter referred to the Intellectual Property Licensing Deed. The letter stated that the practitioner did not have a copy and no copy was enclosed. The letter stated:
"…we are instructed that any benefit flowing from ownership of the Patent (by Kvinno) was passed by Kvinno to TFS Manufacturing under the Deed which commenced on 1 November 2008."
1. This was the first disclosure of the existence of such a Deed. The summary of the effect of the Deed, as provided by the practitioner to his lawyers, was untruthful: the practitioner well knew that ownership of the intellectual property remained with Kvinno, and that the intellectual property in the Patent was held by the Petros Trust.
2. On 3 August 2015 the practitioner's lawyers wrote to the applicant informing it that "Dr Petros did not have a pecuniary interest in the TFS device in any event".
3. On 9 October 2015 a section 34A notice (Health Care Complaints Act 1993) was issued to investigate the financial interest of the practitioner in the device. Thereafter on 20 October 2015, during his section 34A interview with the applicant, the practitioner stated that he had divested himself of any commercial interest in the TFS device; and that Mr Paul Zadow owned the Patent.
4. On 11 November 2015 the practitioners lawyers provided to the HCCC a copy of the IPLD to satisfy the applicant that the property interest in the TFS device was no longer with the practitioner, however, the vital page recording such ownership was missing.
5. The missing page was provided on 13 May 2016. The Tribunal is satisfied that the practitioner deliberately set out to mislead the HCCC and to hamper it in its investigation.
6. Three days before the respondent's letter dated 11 July 2014 in reply to the HCCC's enquiries, he undertook a series of significant financial transaction involving his financial interest in the TFS device, as follows.
1. He resigned as a director of Sappho and surrendered his 50% shareholding in that company in in favour of his eldest son Emanuel Petros. The respondent had been a director and shareholder since 2005. The practitioner had acknowledged that he always considers "anything the family owned as mine" and as such understood that his family interests were equivalent to his own in respect to disclosure obligations.
2. In respect of the Petros Family Trust, the respondent ceased to be a residual beneficiary of the trust as from 7 July 2014. He had been a residual beneficiary since 2005.
3. On 7 July 2014, the respondent retired as guardian and appointer of the Petros Future Trust and was replaced by his wife, Patricia Petros and son, Emanuel Petros. His wife, Patricia, has at all material times been a residuary beneficiary of such trust. Three of the practitioner's children and grandchildren are, and have been at all material times, "primary beneficiaries" of such Trust.
4. The respondent caused alterations to be made to the Intellectual Property Licence Deed (which was entered into on 1 November 2008 between Kvinno and TFS Manufacturing) so as to divest himself of any interest in the intellectual property rights in the TFS device. Prior to this date Kvinno retained ownership of all intellectual property interests in the TFS device. The Deed was executed by the respondent.
1. The respondent asserted in evidence that the changes to his family trust structure and the resignations of his directorships resulted from estate planning advice. He referred to a court decision which he believed resulted in the necessity to make such changes to his family arrangements.
2. The Tribunal observes that on 7 July 2014 the respondent signed a Deed of Variation of the Petros Future Trust. Pursuant to such deed, the trustee, Sappho, declared that as from the date of the deed, the respondent be added to the Excluded Class as defined in clause 6 of the Trust Deed creating the Petros Future Trust dated 1 April 2005. As a result of such variation the practitioner was excluded from any benefit in the Trust.
3. The evidence of the practitioner's accountant established that, since March 2014, the accountant had been in correspondence with the practitioner concerning amendments to his family trust and family financial arrangements, including his directorships and ownership of shares in the family companies. The Tribunal observes that during the section 34A (Health Care Complaints Act 1993) interview in 2016, the practitioner denied he had any interest in the TFS device.
4. The Tribunal found that the evidence of the accountant was not entirely helpful in that he produced only one document in answer to a summons, and did not produce any file or other notes which might have shed some further light on the discussion he held with the practitioner. Further, the Tribunal observes that irrespective of any estate planning issues that might be necessary as a result of a High Court decision in Commissioner of Taxation v Bamford [2010] HCA 10 any amendments to the existing family trust arrangements did not necessitate the removal of the practitioner as a shareholder of the trustee, nor of his removal from the trust as a beneficiary. The facts were acknowledged by Mr Hew. The Tribunal finds that the practitioner attempted to mislead the HCCC by failing to disclose that, up to 14 July 2014, the Respondent held financial interests 1, 2 and 3.
5. The HCCC letter seeking information from the practitioner was written on 18 June 2014. At that date, the three financial interests held by the practitioner existed. In his reply, some three weeks later on 11 July 2014, he failed to mention that only 4 days before, he divested himself of his interests. His statement that he "no longer held" any interest was correct, as at 14 July 2014; it would not have been correct as at the date of the enquiry. The Tribunal finds that the information provided was misleading because of its incompleteness and that the practitioner intended to withhold such information from the HCCC.
6. By virtue of the practitioner's use of the words "no longer held" any interest, it is implicit that he recognised that up to 14 July 2014 he was the holder of the interest in the family companies, trust and the TFS device.
7. Even if the respondent genuinely believed that his financial interests were "indirect" because of his family structures, he must have been aware of the loans which were outstanding from TFS Manufacturing, totalling $1.6 million, and which were owing to the benefit of his family. He was bound to disclose such interest, and his failure to do so was misleading. The disclosure, in his reply to the HCCC, of a debt owing of $62,000 by TFS Manufacturing, yet his failure to disclose the several hundred thousand dollars was also loaned, was clearly misleading.
8. The failure to disclose interest 1, 2 and 3 as referred to above constituted a breach of the Code of Conduct, section 18.12.5, which provides that good medical practice involves:
"Being transparent in financial and commercial matters relating to your work, including your dealing with employers, insurers and other organisations or individuals. In particular:
Declaring any relevant and material financial or commercial interest that you or your family might have in any aspect of a patient's care"
Particular 10
1. The Tribunal refers to the letter dated 11 July 2014 in which the practitioner describes himself as "merely the assistant" in Patient A's surgery. At that time the applicant was unaware that Dr Reid was subjected to a surgical condition that required him to be supervised by the practitioner. The applicant only learned of the conditions imposed by the MAC on Dr Reid's practising on 20 November 2014 when it was informed orally by the TSPH, and thereafter, when it received an RCA on 13 December 2014.
2. The Tribunal is satisfied that the practitioner is not, as he stated in his letter to the applicant on 11 July 2014, "merely the assistant in that surgery". Whilst he may have been listed as the "surgical assistant", the practitioner was present in the surgery for Patient A on 16 July 2013 in his capacity as Dr Reid's supervisor.
3. Dr Gold or the practitioner arranged for patients to be admitted to the TSPH for surgery involving the use of the TFS. The practitioner was recorded as being the lead surgeon in the clinical records. During the surgery in respect of the relevant patients, the practitioner took over when the surgery became complex. The practitioner acknowledges that he performed a substantial part of the operation, and signed his name on the operating theatre record. Whilst Doctor Gold's evidence is somewhat unclear, his final position was that he was not informed of the financial interest which the practitioner held in the TFS device.
4. The Tribunal finds that the practitioner had sought to minimise his involvement in his role as the supervising surgeon and in this respect he misled the applicant.
Improper/unethical conduct
1. The respondent states that, during the hearing of the matter, he accepted professional advice provided to him during the hearing of these proceedings to the effect that the interests held by him through his family trust did in fact amount to financial interests which should have been disclosed. The respondent asserts that he had an erroneous belief; that the belief was false but that he did not act unethically.
2. Such submission having been raised, the Tribunal must determine whether the conduct of the respondent constitutes improper or unethical conduct.
3. The respondent claims that in retrospect, while he acknowledges that his conduct in failing to disclose the financial interest in the family trust was improper, his conduct was not unethical.
4. Section 139B of the National Law sets out the meaning of "unsatisfactory professional conduct" as including (1)(l) "Any other improper or unethical conduct relating to the practice or purported practice of the practitioner's profession". This is to be contrasted with the meaning of "professional misconduct" in s. 139E of the National Law. The Tribunal accepts the expert opinion of Professor Komesaroff and of Dr Geraghty. The Tribunal does not accept the evidence of Dr Eyers because it seeks to address only the issue of "direct" financial interest and not indirect financial interest. Further, it does not address the circumstance where the practitioner at all times was aware of such interest, albeit indirect.
5. Acting District Court Judge Boland in Health Care Complaints Commission v Liu [2016] NSWCATOD 133 considers the terms in the following paragraphs:
51. "The words "improper" and "unethical" are not defined in the National Law. The Macquarie Dictionary defines improper as follows:
1. not proper; not strictly belonging, applicable, or right: an improper use for a thing.
2. not in accordance with propriety of behaviour, manners, etc.: improper conduct.
3. unsuitable or inappropriate, as for the purpose or occasion: improper tools.
4. abnormal or irregular.
52. Unethical is defined as follows
1. contrary to moral precept; immoral.
2. in contravention of some code of professional conduct.
The word improper was the subject of discussion by. French CJ in Parker v Comptroller of Customs (2009) 83 ALJR 494, [2009] HCA 7. The Chief Justice said:
… [t]he relevant ordinary meanings of improper include "not in accordance with truth, fact reason or rule; abnormal, irregular; incorrect, inaccurate, erroneous, wrong".
Decisions involving professional disciplinary proceedings have adopted as relevant the discussion of the term "impropriety" in R v Byrnes and Hopwood(1995) 183 CLR 501; [1995] HCA 1 as being a breach of the standards of conduct that would be expected of a person in the position of the alleged offender (see HCCC v Phung (No 1) [2012] NSWDT 1, Health Care Complaints Commission v Fisher [2016] NSWCATOD 62). The test of whether the conduct is improper is an objective one.
The words improper and unethical were considered by this Tribunal (Dr J Renwick SC presiding) in Office of Local Government v Toma [2015] NSWCATOD 21. Dr Renwick, after quoting from R v Byrnes & Hopwood, noted:
Applying these authorities, I do not need to state an exhaustive definition of improper or unethical conduct. Rather it is enough to here note that the expression encompasses conduct which, viewed objectively, would be regarded by reasonable persons as falling below the standards of conduct to be expected of Councillors, in that it has a tendency to bring into disrepute the civic office held by Councillors, or the Council, or both. In Dallas Buyers Club LLC v iiNet Limited (No 3) [2015] FCA 422 at [5], Perram J said, aptly for present purposes:
The difficulty in locating where a line is to be drawn is a well-known problem in legal discourse. But here, as in other contexts, it is best answered not by seeking to find where the line is but instead by asking which side of the line one happens to be on.
In my opinion the conduct I have found and which the Respondent has not contested clearly falls on the wrong side of the line. It reduces public confidence in the institution of local government. It amounts to improper and unethical.
We adopt the discussion of the principles set out Office of Local Government v Toma".
1. Acting District Court Judge Boland in Health Care Complaints Commission v Sare [2018] NSWCATOD 190 makes the following comments about the meaning of improper or unethical conduct at [30]-[31]:
30 The words "improper" and "unethical" are not defined in the National Law but have been considered in a number of Tribunal decisions.
31 The Macquarie Dictionary defines "improper" as "not in accordance with propriety of behaviour, manners etc or abnormal or irregular" (see also R v Byrnes and Hopwood [1995] HCA 1; 183 CLR 501 at 514-515). Unethical is defined as "contrary to moral precept; immoral; in contravention of some code of conduct". As in Health Care Complaints Commission v Little [2016] NSWCATOD 146, we consider it appropriate to adopt the dictionary definition in construing these words as they appear in the National Law. We note that the words are to be read in the context of s 139B(1)(l), namely that the offending conduct is conduct relating to "the practice or the purported practice of the practitioner's profession".
1. In R v Byrnes and Hopwood [1995] HCA 1; 183 CLR 501 at 514-515 the High Court considered the meaning of the word "improper" in the context of directors duties under corporations law. Specifically their Honours, considered the meaning of this word in s. 229(4) of the Companies (South Australia) Code. Justices Brennan, Deane, Toohey and Gaudron made the following remarks:
"Improper use of position
"Improper" is an indefinite term, not commonly used in the criminal law. Counsel for Hopwood submitted that "improper use" should be understood to mean a deliberate use of position for a proscribed purpose "without giving any consideration at all to the interests of the company". No doubt such a use of position by a director would be improper: it would be an abuse of the power or authority conferred by the position. But, contrary to counsel's submission, that case does not exhaust the categories of impropriety."
1. The Federal Court in O'Connell v Palmer (1994) 53 FCR 429 (see also as reported as R v O'Connell (1994) 76 A Crim R 140) examined the meaning to be attributed to "improper conduct" within the Australian Federal Police (Disciplinary) Regulations 1989 (Cth). Justice von Doussa noted, in part:
The interpretation of the expression "disgraceful or improper conduct" appearing in reg18(1)(d) of the Discipline Regulations was considered by a Full Court of this Court in Hardcastle v Commissioner of Police (1984) 53 ALR 593 at 597. Their Honours said:-
"The expression "disgraceful or improper conduct" is of wide import .... We see no warrant for construing the words of para 18(1)(d) otherwise than according to their ordinary and natural meaning, a construction which is consonant with the evident purpose of the paragraph when considered in the context of the Discipline Regulations as a whole."
1. The National Law does not define "improper" or "unethical". The Tribunal has adopted the dictionary meanings of both terms. The High Court and Federal Court have considered similar terms in a variety of contexts and have on some occasions also adopted dictionary meanings. It appears that the term must be understood in the relevant statutory context.
2. The test of whether conduct is improper is an objective one. However, the individual's state of mind in relation to the allegedly improper conduct is a relevant consideration. In this instance, the Tribunal does not accept the practitioners claim that his failure to disclose his financial interest resulted from a misunderstanding of what constituted a "financial interest". The practitioner had been a long standing director of Sappho (since 1970), the trustee of the Petros Trust, and a beneficiary of a Petros Trust. The practitioner was well aware of the debt owing to the Trust in the order of $1.5 million by TFS Manufacturing. The practitioner was aware that he had received offers to buy the intellectual property from Untied States Corporation. Further, he was aware that the device had been re-engineered from time to time.
3. The practitioner failed to inform the patients referred to in the Schedules and the Sydney Private Hospital (TSPH) of his financial interest in particulars 1 and 2 of Complaint One at the time that he agreed to supervise Doctor Reid. Further, Dr Reid was unaware of the financial interest. The Tribunal finds that such conduct constituted both unethical and improper conduct within the meaning of section 139B of the National Law.
Complaint Two
BACKGROUND TO COMPLAINT TWO
On 11 June 2013, the practitioner operated with two other surgeons on Patient B at the hospital. The surgery involved the use of the TFS device. Patient B suffered significant bleeding after surgery and so was returned to theatre in an attempt to stop the bleeding. It was then decided between the practitioner and the two other surgeons to transfer Patient B to another hospital.
PARTICULARS OF COMPLAINT TWO
1. On 11 June 2013 Patient B was taken by ambulance to St George Public Hospital (SGPH) together with the practitioner. The practitioner gave a handover to a urology registrar on arrival to the SGPH about Patient B's case. The practitioner gave an inadequate and inappropriate handover to the urology registrar in that each of the following respects:
a. he failed to give a comprehensive description of the operations Patient Bhad undergone that day at the hospital;
b. he failed to identify the TFS device used by name or to provide anyaccurate description of the TFS device used;
c. he failed to identify what the known complications of the procedureinvolving the TFS device were;
d. he failed to give a correct sequence of events during and after Patient B'sfirst operation on 11 June 2013 and what steps had been taken to addressthe bleeding and complications;
e. he failed to give adequate information about the stage of the operation atwhich excessive bleeding was noted and the vascular structures whichmay have been the source of the bleeding;
2. The practitioner provided a written report to the hospital's Medical Advisory Committee dated 10 July 2013 (MAC report) about Patient B's surgery and care. The practitioner acted improperly or unethically by the provision of the MAC report which he knew or ought to have known was inaccurate and inadequate and which he did not verify the accuracy of, in that each of the following respects:
a. he wrongly listed the date of Patient B' surgery as 25 June 2013;
b. he failed to describe, or refer to, the use of the TFS device in Patient B'soperation;
c. he failed to describe, or refer to the fact, that Patient B was in recovery forabout four hours at the hospital, that her condition deteriorated and shewas then returned to theatre;
d. he failed to provide adequate information about the choice of hospital forPatient B's transfer including the basis of the decision-making processconcerning which hospital she would be taken to;
e. he inappropriately singled out Patient B's methotrexate as the likely causefor her bleeding event when this was unlikely to have contributedsignificantly to her bleeding;
f. he failed to identify the role the TFS device or its insertion had in thearterial damage and the frequency of this complication during TFSplacement;
g. he inappropriately singled out infection from the cannula line insertion as the source of Patient B's septicemia without noting that the site of infectionhad not been identified and that there were multiple potential sites ofbacterial infection;
h. he advised that Patient B had recovered well and should be discharged soon when this was not an accurate description of her progress and clinical course.
Respondent's Statement
1. In regards to the transfer of the patient the respondent stated:
A bleeding problem occurred during the surgery. First, Dr Reid controlled it and the operation was completed. Later, in the post-op room, pulse and blood pressure observations indicated that the patient was actively bleeding. TSPH did not have the requisite facilities or specialists for the necessary investigations, a decision was made by Dr Reid, Dr Haverfield and me along with Dr Isert (the anaesthetist) to transfer the patient to the closest large hospital. We determined St George Public Hospital was the closest. We also considered that it would be in the patient's best interest for someone familiar with the TFS surgery (such as Dr William Lynch ("Dr Lynch") at St George Public Hospital) to look after her.
On Dr Reid's instruction, I telephoned Dr Lynch of St George Private Hospital. I told him that Dr Reid had operated on the patient at TSPH, being a vaginal sacrocolpopexy and enterocoele repair. She had bleeding issues but these had resolved. Her condition then deteriorated. She had to be transferred. I asked if he would accept her under his care. He agreed.
As Dr Reid indicated that he was not going to accompany the patient but would write up the notes. I volunteered to go with the patient, along with Dr Isert in the ambulance while she was transferred to the ICU at St George Public Hospital.
On arrival at St George Public Hospital, Dr Isert and I met with the ICU doctor and I told him that she had a vaginal operation. She had bled from the dissection on the posterior vaginal wall, that the bleeding had continued, that she had developed a
coagulopathy and that she needed intensive care and that an admission had been arranged under Dr Lynch.
I told him that the repair involved her uterosacral ligaments with scissors dissection in the ligament and the insertion of an anchor and tape into the ligaments to attach them to the sacrum. Her condition deteriorated in recovery so she was brought back to the operating theatre, where haemoperitoneum was noted and she received multiple bottles of blood.
Due to the adverse outcome, the MAC of ISPH investigated the incident. I knew that a Root -and Branch inquiry was initiated.
In about July 2013, I had verbal discussions with the chairperson of the MAC about it. As part of this investigation, I was asked to provide details in writing. At this time, I also provided a written report based on what I could recall from memory as I did not have access to the hospital clinical notes. I also provided a further undated report that only dealt with the patients' surgery and not Dr Reid's supervision in general.
I attach an email to Michelle Sloane then of MAC of ISPH of 10 July 2013, which attached the report that I sent to Dr Swinburn, chairperson, of MAC, marked with the letter "B". The email states that I had spoken to Dr Swinburn already about the incident for two hours.
The fact that I wrote the incorrect date of the incident was primarily due to the fact I was reliant on my memory. It was an error. I only provided details that involved me to the best of my ability, as I was aware that the MAC had sought information from Dr Reid-as the lead surgeon and reviewed the clinical notes. I therefore believed that most of the details that were required were already known to the MAC.
I did not include details that I was not directly responsible for, such as the choice of hospital for the transfer. I also qualified my responses such as stating that / believed that she had recovered well and should be discharged soon. As the patient was not my patient, at all times I relied on Dr Reid for information about her progress, about which he stated he rang 2-3 times per week.
At no stage did I intend to mislead the MAC with my reports, particularly as I was of the firm understanding that the MAC would have been well aware that Dr Reid's surgery involved the use of the TFS device and the events leading up to the transfer.
Expert Evidence
Dr William Lynch
1. Dr Lynch is a urological surgeon and was practising at St George Private Hospital at all relevant times. He had previously performed several surgical procedures with the practitioner involving the TFS device.
2. Dr Lynch provided a statement concerning the events of a handover. He states that on the afternoon of 11 June 2013, he received a telephone call from Professor Petros. Dr Lynch states that the respondent informed him that he had been operating with Dr Reid at the Sydney Private Hospital and the patient had undergone vaginal sacrocolpopexy and enterocoele repair. Dr Lynch was informed by Dr Petros that problems had been experienced with bleeding but that the bleeding had stopped and that the patient would be discharged, as planned, on the following day. However, as a precautionary measure, the anesthetist had suggested that she be monitored overnight in a hospital that had in-house resident cover, which was not available at the Sydney Private Hospital.
3. Dr Lynch informed the respondent that Dr Petros only had assistant rights at St George Private Hospital. The respondent asked whether the patient could be admitted under the name of Dr Lynch. Dr Lynch agreed.
4. Later that afternoon a second call was received from Dr Petros who advised that the patient's condition had deteriorated as she was bleeding and unstable. Dr Lynch recommended that she be taken to Royal Prince Alfred Hospital as it was closer to the Sydney Private Hospital and there was an emergency department at that hospital. He was then informed that they were already in the ambulance and that they were on their way to St George Private Hospital. Dr Lynch told Dr Isert, the anesthetist that the ambulance should go to the St George Public Hospital. Dr Lynch then telephoned the emergency department of St George Public Hospital to inform them that the patient would be arriving and that emergency assistance would be required because of uncontrolled bleeding resulting from "some sort of injury to the pelvic blood vessels". Dr Lynch suggested that the patient would need vascular intervention.
5. Dr Lynch states that he was named as the admitting officer of record and was informed that the patient's situation was critical and that emergency surgery was required to stop the bleeding.
6. Dr Lynch went to St George Public Hospital and met Dr McMullen, a vascular surgeon, for the purpose of managing the patient.
Dr Kieran Hart
1. Dr Kieran Hart, urologist, was the urology registrar at St George Hospital on 11 June 2013 when the ambulance containing the patient, the anaesthetist, Dr Isert, and the respondent arrived at St George Hospital.
2. Dr Hart had obtained his bachelor of medicine/bachelor of surgery from the University of Queensland in 2006 and was registered as a medical practitioner on 15 December 2006. He is now a fellow of the Royal Australian College of surgeons specialising in urology. At the time he was four years into his accreditation training as a urologist.
3. At about 7 PM on 11 June 2013 Dr Hart was contacted by Dr Bill Lynch, urologist and advises that the patient was being transported from Sydney Private Hospital. He was informed that the patient was bleeding heavily after trans-vaginal surgery.
4. Dr Hart recalls the respondent saying that the patient had a sacrocolpopexy and had a bleed. He recalled Dr Petros informing him that he had put transvaginal sutures in but she kept bleeding. He understood that while she was in recovery, she had hypotension and was taken to theatre.
5. Dr Hart remembered the patient's arrival and stated:
"Dr Petros didn't go into too much information about the type of surgery she underwent and I presumed it was just a standard sacrocolpopexy procedure. Afterwards Dr Lynch gave me a rundown on sacrocolpopexy surgery as I was not too familiar with this type of surgery. In general not many urologist would do this procedure, as it is mainly urogynaecologists who perform it."
1. Dr Hart recalled that Dr Petros told him that he (Dr Petros) was doing the surgery with the surgeon, Dr Richard Reid. Dr Hart was not sure who performed the first surgery but he believed that Dr Petros placed the oversewing sutures.
2. Dr Hart stated that it quickly became apparent that the patient did not have a urological injury but had a vascular injury. As such a vascular surgeon was called in to take the care of the patient.
3. During his cross examination, Dr Hart said that he could not be certain whether other information had been provided to him, as he was not required to provide a statement until September 2017, some years after the event. However, the clinical notes made by Dr Hart, at the time of the handover, are instructive. The notes record:
"Had transvaginal utero sacral colpopexy; haemorrhage during OT; vessels over sewn; post op hypotension; return to OT; further over sewn. Transfused –? Discussed with Dr Lynch and arranged transferred to St George".
1. The respondent made no written notes of the handover. However, in his responses to the HCCC the following is recorded:
"At the transfer, the anaesthetist handed over the observations taken in the ambulance and I told the doctor who took over that the patient had vaginal operation which had bled from the posterior wall, that the bleeding had continued, that she needed intensive care and that an admission had been arranged under Dr Lynch. Whether he passed this on to Dr McMullen I do not know. I quote from Dr Isert: "Professor Petros provided a detailed assessment to the ICU fellow upon arrival to the ICU."
Michelle Sloane
1. Ms Michelle Sloane was the corporate manager for the Macquarie Health Corporation and the hospital Director for the Sydney Private Hospital ("the hospital"). At the relevant time she was also a member of the Medical Advisory Committee (MAC) of the hospital. She held no medical qualifications but had been trained as a nurse.
2. Ms Sloane recalls that in September 2012 the respondent applied for clinical privileges as an accredited visiting medical practitioner at the hospital. Ms Sloane reviewed the respondent's application and observed that the scientific achievements referred to in his curriculum vitae included the development of the TFS. Ms Sloane also recalled that the respondent attended an MAC meeting in about mid 2013 where he presented his credentials and medical experience.
3. Ms Sloane said that she recalled Dr Petros stating to her, and to the MAC that he had "absolutely no financial interest in the system" she also recalled him stating that he had "received no monetary gain" from the TFS system. She drew the inference from such statements that the respondent would have no future gain resulting from the use of the TFS. Ms Sloane said that Dr Petros voluntarily informed her of such information. She had not asked any further questions about the non-monetary benefit and did not occur to her to do so
4. Ms Sloane recalled that Dr Petros came to the hospital as a supervisor, particularly to supervise Dr Reid who had been suspended from the hospital in May 2013 as a result of an incident that occurred in relation to a patient.
5. Ms Sloane recalled that there was discussion about the creation of a "centre of excellence" at the hospital, but said that the respondent did not promote such concept.
6. Ms Sloane stated that it was agreed by the hospital that the respondent would supervise Dr Reid only if, in his operative procedures, Dr Reid adopted the TFS. The respondent was to report every six weeks to the MAC. Ms Sloan considered that it was an unusual circumstance to have supervision of a gynaecologist. To her knowledge the respondent never took a lead role in any surgery but he was acting as supervisor and assistant of Dr Reid.
Professor Komesaroff
1. Professor Komesaroff was asked about the fact that the practitioner travelled with the patient in the ambulance to hand over her care to doctors at St George Hospital and failed to properly advise doctors of the nature of the surgery she underwent namely TFS; the fact that this was the first time that the principal surgeon had carried out the surgery and that he had been present in his capacity as "director, supervisor and trainer" of the surgery.
2. Professor Komesaroff stated:
Dr Petros' actions in travelling with the patient in the ambulance were appropriate and consistent with a commitment to her continuing care. However, to discharge his responsibilities in this capacity adequately Dr Petros was obliged to provide the doctors to whom he was handing over care with all relevant information about her medical condition. This would undoubtedly have included a sufficient or "proper" account of the nature of the surgery she had undergone. If Dr Petros had omitted details about the surgery of which he was aware and as a result of such omission the patients' care or welfare had been adversely affected this would have constituted a serious misconduct on his part.
1. Professor Komesaroff continued:
Dr Petros and Dr Reid were under an obligation to ensure the transfer of the patient to the most appropriate hospital, having regard to the patients' medical condition and her need for care. It may well be the case that a doctor asks a trusted colleague for assistance and advice; however, it is the needs of the patient that should always take precedence over any other consideration. If the Royal Prince Alfred Hospital was in fact the most suitable hospital to care for the patient she should have been transferred there.
Dr Petros was obliged to seek the best and most appropriate care for the patient. If it was not appropriate for Dr Lynch to take over her care Dr Petros should not have sought this, or else he should have sought an alternative when it was pointed out to him that this was the case. The fact that Dr Lynch had had no previous role in her care was not relevant. The geographical distance of a hospital may be a consideration in the choice of hospital but is not necessarily a decisive factor.
The provision of a "misleading report" itself would be ethically inappropriate conduct.
1. Professor Komesaroff also stated:
Nonetheless, as previously mentioned, Patient B was entitled to know all the facts that could have been relevant to her decision regarding surgery, and these would certainly have included the knowledge about Dr Petros' personal experience and interests. It was Dr Petros' obligation to assure himself that the information had been conveyed to the patient, although it was not essential that he communicate it directly himself.
Dr McCarthy
1. Dr Sally McCarthy is a specialist emergency physician and has been in practice for 30 years. She provided a report concerning the transfer of patient B.
2. Dr McCarthy noted that the medical officer who received the patient at the St George public hospital was Dr Oh. There was a pre-arrival note which resulted from an exchange of information by telephone. The report indicated that the patient was bleeding, and was unstable. The note recorded that the patient had undergone trans-vaginal surgery.
3. Dr McCarthy stated that the more detail which is provided, the better. She noted that the respondent arrived in the ambulance with the patient.
4. Dr McCarthy considered that detail should have been provided concerning the use of a device in the surgery, namely the TFS. She considered it was essential to disclose that fact. Details of the blood transfusion already provided to the patient would have been helpful. Further, details concerning where the device was planted and of any known complications with the device was required.
5. Dr McCarthy states that whilst the patient had been in recovery, she received 12 units of blood and that significant resuscitation was required. Dr McCarthy considers that the receiving surgeon should have been informed of these matters, together with what measures was undertaken to stop the bleeding.
6. Dr McCarthy explained that in most cases of haemorrhage after vaginal surgery, it is known which are the most likely blood vessels involved. Hence a detailed description of the operative procedure is not always essential. However she acknowledged that as this was not a standard vaginal repair, the source of the bleeding was less predictable. In the circumstances of this handover, precise surgical details would have been important as this could have impacted management.
7. For these reasons, Dr McCarthy considered that it was essential that the use of the device and its location was essential information. Further, she commented that if the receiving medical staff was not informed that a device was used, they would not consider this possibility and accordingly would not be asking questions about it.
Doctor Geraghty
1. Dr Geraghty commented that, based upon the information provided to Dr Kieran Hart, urology registrar, who accepted the patient on 11 June 2013, the information provided by the respondent on the handover was inadequate.
2. Dr Hart assumed that the procedure was a sacrocolpopexy, being an open abdominal procedure or laparoscopic procedure. Dr Geraghty considers that Dr Hart should have been provided with a comprehensive description of the operation, including what known complications of the procedure were in the correct sequence of events during and after the operation together with the steps taken to address the problem. If such description was not provided, Dr Geraghty considers the respondent's hand over was significantly below the standard expected.
3. Dr Geraghty was asked to review the report made by the respondent dated 10 July 2, 2013 to the MAC concerning the patients' surgery and care. Dr Geraghty noted that the report was completed approximately a month after the events. He observed that the respondent provided the wrong date of the surgery namely 25 June 2013 instead of 11 June 2013. Further, he made no reference in the report to the MAC that the TFS device had been used in the surgery.
4. The respondent attributed the patient's complication to methotrexate that she was taking for her arthritis and claimed that it had caused her platelets not to clot adequately. He also stated that the patient had a haematoma surgically evacuated but that her recovery was complicated by the development of septicaemia which traced to an infected intravenous line.
5. Dr Geraghty considered that the seriousness of the situation required a detailed report which was accurate. Further he states:
"Dr Petros would have known by the time of making his statement to the MAC see that the patients' surgical complication involve damage to a branch of the internal iliac artery which occurred during her surgery. As it was an arterial bleed, her taking methotrexate is unlikely to have contributed to her problem in any substantial way, since lack of platelets was not because of bleeding."
1. Dr Geraghty states that:
"it is clear from the clinic reports that the patient had a significant vascular injury and that as time went on is becoming more difficult to keep up with her blood loss. As a result it was decided ultimately to transfer her to St George Private Hospital but then a decision was made to proceed to St George public hospital. Dr Petros telephoned Dr Lynch at St George Private Hospital and asked whether he would accept her care. He declined to do so and suggested Royal Prince Alfred Hospital. Dr Lynch recommended that the patient be transferred to Royal Prince Alfred Hospital which was a well-equipped hospital. However it was claimed that as the ambulance was already on its way to St George public hospital, it should continue."
1. Dr Geraghty considers that if it was the intention of the respondent to mislead the MAC concerning his knowledge of and role in the patient's case, the supply of inaccurate and inadequate information in the report constituted unethical conduct and a breach of the code, clause 8.8.
Complaint Two Observations
The handover of the patient
1. The electronic record of St George Public Hospital, Emergency Documentation relating to the admission of the patient records:
Phone call from Bill Lynch (urologist) - patient to be transferred from Sydney Private Hospital (Ashfield) after becoming unstable post op. Had vaginal sacrocolpopexy and enterocele repair. On extubation became HD unstable and dropped Hb. Given 6units packed cells and about to get FFR HR 96, BP 99 then 110 sys post resus, sats 99% on 10L. Has art line, IDC and IVC. Please call urology registrar on arrival. Admit Lynch (+any other team that needs to be involved)
1. The above note was apparently prepared by Dr Oh, the Emergency Department consultant. Her information resulted from a telephone call received from Dr Lynch, who had been telephoned by the respondent at approximately 3:30 PM on the afternoon of 11 June 2013. The respondent informed Dr Lynch, the visiting medical officer of St George Private Hospital, that he had a patient who may require admission to George Private Hospital for overnight observation, as she had been bleeding. Both practitioners knew one another from prior surgical procedures.
2. A second telephone call was made by the made by the respondent, or by the anaesthetist, Dr Isert, to Dr Lynch, sometime later, during which he was informed that the patient's condition had deteriorated, that she was bleeding and unstable. Dr Lynch suggested that the patient be taken directly to Royal Prince Alfred Hospital Emergency Department.
3. Following that conversation, the anaesthetist telephoned Dr Lynch. Dr Lynch was informed that the anaesthetist, the respondent, and a patient were in an ambulance en route to St George Private Hospital. The anaesthetist informed Dr Lynch that the patient was very unstable. The journey to St George Private Hospital had already commenced.
4. Dr Lynch responded that the ambulance should go to the St George Public Hospital, and that he would telephone that hospital's Emergency Department to advise him of the patient's impending arrival and that she was unstable and bleeding. Dr Lynch advised the senior medical officer by telephone at St George Public Hospital that the patient had become unstable post operatively, had been given six units of packed cells and other details concerning her condition.
5. On arrival at the hospital, there was a conversation between the respondent and Dr Hart. According to the statement of Dr Hart, the respondent "didn't go into too much information about the type of surgery she underwent and I presumed it was just a standard sacrocolpopexy procedure."
6. The version of events provided by the respondent in his statement dated 3 November 2016 provided under section 40 of the Health Care Complaints Act does not materially differ from the version provided by Dr Hart. At paragraph [93], the respondent stated:
At the transfer, the anesthetist handed over the observations taken in the ambulance and I told the doctor who took over that the patient had had a vaginal operation which had bled from the posterior wall, that the bleeding had continued, that she needed intensive care and that an admission had been arranged under Dr Lynch. Whether he passed this on to Dr McMullen I do not know. I quote from Dr Isert. "Professor Petros provided a detailed assessment to the ICU fellow upon arrival to the lCU…"
1. No mention was made of the use of a TFS device. Dr Isert has provided a statement. In respect of the critical events surrounding the handover of the patient he states:
Involvement in patient care at StGP.
Upon arrival to StGP Emergency Dept I personally handed over to the
Duty Consultant who received us. She knew about our transfer & she organised our prompt transfer to the ICU whilst still on our ambulance bed. ICU were expecting us and the ICU Fellow attended us immediately. I gave a complete handover to this Fellow whilst staying for about 15 mins to complete the administration of more PCs, FFP & platelets that I had attained & commenced in the ambulance. I was also required to help with transfer of the patient onto both the ICU bed & the ICU ventilator
1. The transcript of the section 34A interview records the respondent statements concerning the handover. After discussion that it was Dr Lynch who arranged the admission, and the acknowledgement that the removal of the patient to the hospital was "about damage control" the respondent stated:
"But he would have transmitted to a responsible person the information that a patient was coming in that was bleeding after pelvic floor surgery at the Sydney Private Hospital".
1. In the statement which the respondent provided to the Tribunal dated 19 February 2019, the respondent provided a far more detailed description, than was provided by him previously. At [57] of such statement the respondent states:
"I told him that the repair involved her utero sacral ligaments with scissors the section in the ligament and the insertion of an anchor and take into the ligaments to attach them to the sacrum. Her condition deteriorated in recovery so she was brought back to the operating theatre, where haemoperitoneum was noted and she received multiple bottles of blood."
1. The progress/clinical notes prepared by Dr Hart record amongst other details: "had transvaginal uterosacral colpopexy."
2. There is no record of the precise surgery, nor the fact that a TFS device was used in the surgery.
Complaint Two Tribunal Finding
Particular 1(a)
1. Two people were critical in providing the handover information to the receiving registrar, namely the respondent and Dr Isert.
2. Dr Isert is a specialist anaesthetist and would be expected to handover with regard to the patient's airway, breathing, circulation and any drugs and fluid that had been administered, in addition to any physical observations he had observed during the transportation of the patient.
3. The respondent, a specialist surgeon, would be expected to handover details of the surgery performed and the most likely source of bleeding so that the receiving team could combine these two streams of information to plan and direct further management of the patient. It should be observed that the anaesthetist will not be fully apprised of the surgery which has been conducted on the patient.
4. All the information recorded in writing, including the notes of Dr Hart, establishes that the receiving doctors were not informed of the precise nature and extent and associated risk of the surgery that was performed by the respondent.
Particular 2(b)
1. This particular asserts that the respondent wrongly identified the date of Patient B's surgery. The respondent acknowledges that this was a mistake.
2. Particular 2(b) also alleges that the respondent failed to identify the TFS device used by name or to provide any accurate description of the TFS device used. The Tribunal finds that the opinion of Dr McCarthy is correct, namely that the respondent should have identified the TFS device by name or provided an accurate description of the device that was used in the surgery. This lack of information had the potential to impact upon patient management.
3. Despite the lack of detail provided by the practitioner in his report to the MAC, the respondent notably failed to mention the use of the TFS device. Yet in his statement made on 19 February 2019, namely six years after the event, the practitioner gave a very detailed account of his instructions to Dr Hart which included a reference to the TFS device.
4. The Tribunal finds that the account provided by the respondent in his 19 February 2019 is reconstruction and cannot be treated as a true account of the actual details which occurred in June 2013. The Tribunal notes that no such detail was provided to the MAC and no detail of the kind now put forward by the respondent, was referred to in the information he provided to the HCCC as set out above.
5. The Tribunal accepts the expert opinion of Professor Komesaroff concerning the necessity to provide a full description of the surgical procedure undergone by the patient when she was handed over to St George Public Hospital. The Tribunal also accepts the expert opinion of Dr Geraghty that the description provided by the practitioner of the patient's surgery was inaccurate. He considered that a comprehensive description was described, what the known complications were and what steps had been taken both before and after the operation to address the problem.
6. The Tribunal gives little weight to the evidence of Associate Professor McCarthy because of its generalised nature.
7. The Tribunal concludes that the particulars a – e inclusive to paragraph 1 of Complaint Two have been established.
Complaint Two: Report to the MAC
1. This complaint alleges that the respondent acted improperly or unethically in the provision of a report which he made on 10 July 2013 to the MAC of the hospital in respect of the surgery performed upon the patient.
2. The report, which is surprisingly brief, seeks to minimise the course of the surgery and the nature of the complications suffered by the patient. The date of the surgery provided in the report is inaccurate. However, accepting the respondent's statement that this was a mistake, the fact is that the report is deficient in that:
1. There is no mention that a TFS device was used; accordingly the MAC could not have been aware that there could have been a variety of potential vascular sources of the bleeding;
2. The severity of the complications is not described: in particular, there is no record that the patient was undergoing recovery for approximately four hours at the hospital; that her condition deteriorated; and that she was then returned to theatre;
3. The respondent did not describe how he and Dr Reid decided to transport the patient to St George Hospital, at twice the distance from Royal Prince Alfred Hospital, which is most concerning;
4. The respondent claimed that the patient's methotrexate was the likely cause of her bleeding. In view of the fact that the patient had acute arterial bleeding, a surgical cause, and the fact that there been no haematological evidence of any bone marrow dysfunction prior to the operation, the reason provided was not a sufficient explanation. Further, the patient had had specialist physician review only a week prior to the surgery and had been cleared fit for surgery;
5. The respondent downplayed any potential role of the primary surgery as a potential source of infection in the patient; and
6. The respondent apparently made no direct enquiry upon which to base the assertion contained in his report that the patient had recovered well and should be discharged soon. In fact the patient was not discharged for a further period of four weeks.
1. The Tribunal accordingly finds that paragraph 2 of Complaint Two is established.
Complaint Three
1. This Complaint relies upon the Complaints referred to in Complaint One and Two, as justifying a finding that the conduct of the practitioner constitutes unsatisfactory professional conduct or professional misconduct.
2. The Tribunal finds that all Complaints, subject to the Complaint that the practitioner deliberately effected the transactions to divest himself of his financial interests, to mislead the HCCC, established. Further, the Tribunal finds that the conduct of the practitioner in relation to the handover as referred to in Complaint Two constituted unsatisfactory professional conduct to such a serious degree as to constitute professional misconduct. Accordingly, the Tribunal finds that the practitioner is guilty of professional misconduct as alleged in Complaint Three.
Disciplinary Sanction
1. The practitioner stated that he is now 78 years of age, has ceased practice and has no intention of practising again.
2. The Tribunal's primary function under section 3A of the National Law, is the protection of the public. If the practitioner had continued to practice, the Tribunal would, pursuant to section 149C(4) (a) of the National Law have ordered a cancellation of registration and would have ordered that the practitioner be disqualified from applying for registration for a period of two years from the date of cancellation. Since the practitioner will no longer be practising, no disciplinary sanction can be directed by the Tribunal. Nevertheless, it is in the public interest that the practitioner's conduct be recorded.
Costs
1. Under Schedule 5D, cl 13 of the National Law, the Tribunal has the power to require a party to pay the costs of another: Health Care Complaints Commission v Philipiah [2013] NSWCA 342. This decision confirmed that costs should be borne by an unsuccessful party.
2. Since the findings by the Tribunal support the allegations of the Complainant, the Tribunal finds the respondent should bear the costs of these proceedings.
Orders
1. Order that if the respondent were still registered:
1. pursuant to section 149C (4) (a) of the National Law his registration would have been cancelled;
2. pursuant to section 149C (4) (b) the respondent be disqualified from being registered as a medical practitioner for two years;
3. pursuant to 149C (4) (c) of the National Law the National Board record that the Tribunal would have cancelled the respondent's registration in the National Register kept by the Board;
4. pursuant to section 149C (7) of the National Law order that the respondent cannot seek a review of the orders made by the Tribunal for a period of two years;
5. pursuant to section 163 of the National Law the Tribunal is the appropriate review body for any review of these orders
1. the respondent is to pay the costs of the applicant of and incidental to these proceedings.
2. the publication of the name of any patient referred to in this decision be prohibited.
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I hereby certify that this is a true and accurate record of the reasons for decision of the Civil and Administrative Tribunal of New South Wales.
Registrar
Amendments
05 June 2019 - solicitors for the parties names corrected in coversheet
DISCLAIMER - Every effort has been made to comply with suppression orders or statutory provisions prohibiting publication that may apply to this judgment or decision. The onus remains on any person using material in the judgment or decision to ensure that the intended use of that material does not breach any such order or provision. Further enquiries may be directed to the Registry of the Court or Tribunal in which it was generated.
Decision last updated: 05 June 2019