Medical Board of Australia v Dr FA (No 2)
[2012] QCAT 288
•6 July 2012
| CITATION: | Medical Board of Australia v Dr FA (No 2) [2012] QCAT 288 |
| PARTIES: | Medical Board of Australia (Applicant) |
| v | |
| Dr FA (Respondent) |
APPLICATION NUMBER: OCR120-11
| MATTER TYPE: | Occupational regulation matters |
HEARING DATE: Oral hearings: 1 February and 19 March
2012
On the papers: 20 April 2012
HEARD AT: Brisbane
| DECISION OF: | Judge Fleur Kingham, Deputy President Assisted by Dr Reza Adib Ms Bronwyn Herbertson Dr Ross Taylor |
DELIVERED ON: 6 July 2012
DELIVERED AT: Brisbane
ORDERS MADE: | 1. The Tribunal finds Dr FA has engaged in unprofessional conduct. 2. The matter will be listed for an oral hearing on sanction on a date to be advised by the Registrar after consultation with the parties. 3. If a party seeks directions from the Tribunal about filing material before that hearing, they must consult the other party about the proposed directions before applying to the Tribunal for directions. |
| CATCHWORDS: | OCCUPATIONAL REGULATION – HEALTH PRACTITIONER – MEDICAL PRACTITIONER – DISCIPLINARY – Where the registrant composed and published a website providing instructions for conducting medication termination of pregnancy without medical supervision – where the registrant promoted the website in the media – where the registrant provided advice on how to procure Misoprostal without lawful prescription – whether the website provided generic medical information – whether the information provided complied with the relevant professional guidelines – whether the registrant provided instructions for medically unsupervised terminations where she knew or ought to have known that the procedure was unsafe – whether the material appropriately warned users of the risks associated with unsupervised medical terminations – whether the registrant’s actions constitute a grounds for disciplinary action Health (Drugs and Poisons) Regulation 1996, rr 190, 193 |
APPEARANCES and REPRESENTATION (if any):
| APPLICANT: | Ms Kathryn MacMillan, instructed by Minter Ellison for the Board |
| RESPONDENT: | Dr FA appeared in person |
REASONS FOR DECISION
Dr FA, an experienced specialist in obstetrics and gynaecology, established a website safehomeabortion.com.au which provided instruction on how a woman might terminate her pregnancy using a drug regime and without medical supervision. Shortly afterwards, Dr White, the Chief Executive Officer of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, brought the Board’s attention to a newspaper article quoting Dr FA, which referred to the website, and which was published on the day the website was launched.
The Board alleged Dr FA’s conduct in establishing and promoting the website constitutes a ground for the Tribunal to take disciplinary action against her.[1] Although Dr FA accepted responsibility for creating the website, she denied she engaged in unprofessional conduct.
[1]The proceedings were commenced pursuant to Health Practitioner Regulation National Law Act 2009, Schedule, s 193.
What is the Board’s case against Dr FA?
Because, at times, Dr FA appeared to misunderstand the nature of these proceedings, the Board took some trouble at the oral hearings and in its written submissions to dispel possible misconceptions about its case.
The Board did not assert that Dr FA breached conditions imposed on her registration following earlier and unrelated disciplinary proceedings. Rather it alleged Dr FA had engaged in professional misconduct or unsatisfactory professional conduct because:
(a) she presented material on the website as expert medical advice;
(b) she provided generic medical information without complying with relevant professional guidelines requiring the assessment of patients, arrangements for urgent medical care (if it became necessary), and follow up care and support;
(c) she provided instructions for medically unsupervised terminations which are unsafe in circumstances where Dr FA knew or ought to have know that the procedure was unsafe;
(d) she failed to appropriately warn users of the risks of medically unsupervised terminations of pregnancy;
(e) she provided advice to users as to how to obtain the drug Misoprostol without a lawful prescription, including over the internet; and
(f) she advocated and promoted the website in the media.
Dr FA told the Tribunal she posted the website in response to the prosecution of a young couple in North Queensland for a criminal offence of attempting to procure an abortion. She said this case reinforced her strongly held concerns about the circumstances in which a woman may lawfully terminate a pregnancy in Queensland.
The Board submitted that it made no comment about the morality of termination of pregnancy, the appropriateness of the current level of access to these services in Australia or whether law reform in the area is warranted. It argued such matters are not relevant to these proceedings.
What is not in dispute?
There are a number of matters about which Dr FA and the Board agreed. Dr FA conceded she posted on the website the material tendered by the Board. She also agreed that the material provided advice and instruction about how to achieve a medically unsupervised termination of pregnancy. She admitted it was presented as expert medical advice, and submitted that the fact that it was offered by a medical expert makes it far more reliable and reassuring to patients and their carers.
What is in dispute?
Dr FA did not concede:
(a) that the information failed to comply with relevant professional guidelines;
(b) that medically unsupervised terminations are unsafe;
(c) that she failed to appropriately warn users of the risks of medically unsupervised terminations of pregnancy;
(d) that providing some information about how to obtain the drug Misoprostol without prescription, constituted unsatisfactory professional conduct; and
(e) that she advocated and promoted the website.
(a)Did the website provide generic medical information without complying with relevant professional guidelines?
The Board alleged the website provided generic medical information without reference to relevant professional guidelines. Dr FA conceded this, in the sense that the material was not directed to a specific patient, instead providing a broad comprehensive umbrella of information to individuals and the general public, including health care providers.
However, she denied there was no reference to relevant professional guidelines. In her submissions, she asserted the website displayed professional guidelines along with other evidence regarding misoprostol, mifepristone, methotrexate, ergotamine, oxycontin, together with analgesics and many other pharmacological preparations relevant to female health care provision.
Dr FA said the Board did not appreciate or acknowledge the full extent of information provided, and accused the Board of having cherry-picked aspects which it believed would be useful in its harassment of her.
It is troubling that Dr FA made this assertion at such a late stage of the proceedings. Although Dr FA is self represented, she has past experience of Tribunal procedures and was given many opportunities, during this matter, to produce material she considered to be relevant. For reasons set out towards the end of this decision at [104] to [110], the Tribunal rejected Dr FA’s suggestion that the Board has misrepresented the material accessible through the website.
The evidence from the Board about the website is contained in the affidavit of Catherine Miedecke. Attached to her affidavit (CM-2) are printouts from the website dated 3 August 2012, a CD of videos presentations by Dr FA accessible on the website and transcripts of those presentations. On one page of the printouts, the following statement appears:
The following are guidelines and suggestions provided by various prestigious institutions regard (sic) abortion and other associated health issues.
There followed links to the RANZCOG guideline on termination of pregnancy; the Royal College of Obstetricians and Gynaecologists guideline on Abortion Care; and documents from the World Health Organisation relating to medical abortion and the Millenium Development Goals. The Tribunal has assumed those links were active and did take the website user to those documents.
Although it is by no means clear, Dr FA’s case seems to be that those links disproved the Board’s allegation that the website provided generic medical information without complying with relevant professional guidelines. This misconceives the objection the Board has to the material posted by Dr FA.
The Board obtained an expert opinion from Dr Daniel Challis, Medical Co-Director of the Maternity Division at the Royal Hospital for Women in Randwick, NSW. Dr Challis is a practicing obstetrician with over 15 years experience in both high risk and general obstetrics. He is a certified sub-specialist in maternal foetal medicine and is on the Register of Expert Witnesses maintained by the RANZCOG for both general obstetrics and maternal foetal medicine. He has been involved in medical and surgical termination procedures for more than 20 years.
Dr FA conceded Dr Challis’ expertise, although she contested aspects of his opinion. She did not call any contrary expert evidence, instead relying, in an un-particularised way, on the large volume of documentary material she tendered.
In his report dated 27 October 2010, Dr Challis identified the relevant guideline is that published by the RANZCOG in 2005. He summarised the requirements of the guideline for a termination of pregnancy using a drug regime without surgical intervention (known as a medical termination). In his view, it was quite clear that none of the following safety mechanisms could be put in place in an unsupervised home termination of pregnancy:
(a) the provision of clear information to women about what to expect;
(b) the necessary follow up;
(c) information on how to recognise complications;
(d) access to urgent care;
(e) provision of 24 hour telephone advice;
(f) arrangements for uterine evacuation when needed;
(g) arrangements for emergency care if required; and
(h) arrangements for ensuring appropriate follow up.
The provision of links to various professional guidelines does not answer the Board’s allegation that the information provided on the website was generic and did not comply with the guidelines.
The instructions given by Dr FA do not satisfy the requirements imposed on obstetricians and gynaecologists by the RANZCOG guideline in relation to access to information and advice and access to emergency and follow up care. Dr FA purported to provide women with detailed step by step instructions about the process of undertaking medical terminations, without reference to any of the safety mechanisms identified by Dr Challis.
To explain how the Tribunal reached that conclusion, it is necessary to descend to some detail about the statements made by Dr FA in her instructions. The Tribunal has not extracted the instructions in full. The sections reproduced in these reasons are representative of the nature and tone of the instructions given by Dr FA and serve to illustrate the basis for the Tribunal’s conclusion.
The subtitle of the website was the rather incongruously whimsical title:
The Planet Guide for Lonely Females
Do it Yourself Termination of Pregnancy
The website assured users that
plain and simple instructions are given and scientific evidence and personal practice experience are detailed for reassurance to patients and their health care attendants (when fortunate to have such)... It provides step by step instructions regarding the termination of pregnancies.
Each page of the website print out contained the following disclaimer:
This web site is provided for educational purposes only. All medical concerns should be addressed in person with your doctor or pharmacist.
The disclaimer had less prominence than other statements on the website. It appeared in smaller font than the rest of the text and was located at the bottom of each page. It was inadequate to counter the strong impression, arising from the detailed instructions, that a woman could safely perform a medical termination on her own, without medical supervision.
Dr FA acknowledged the possibility that a woman might not have any health care attendant by the statement that the instructions and other information were given for reassurance to patients and their health care attendants (when fortunate to have such). Although that might convey the impression that a health care attendant might be desirable (but not what qualifications they might have), it implies such assistance is unnecessary.
That implication was expressly reinforced in the detailed instructions given by Dr FA in her video presentations (transcripts were also available on the website). A person listening to (or reading) Dr FA’s instructions could not reasonably think that she was providing information for educational purposes only or that the procedures she detailed should only be undertaken under medical supervision.
To the contrary, the listener (or reader) would have good cause to feel reassured by Dr FA’s evident expertise. In relation to early first trimester terminations Dr FA stated:
Up until 10 weeks of pregnancy (that is 2 missed periods) this is a proven, safe and efficient method which does not require hospitalisation or even medical or nursing care other than what may be needed in the community for spontaneous miscarriages.
Dr FA also sought to equate medically inducted terminations with spontaneous miscarriages during her cross examination of Dr Challis, a proposition that he did not accept.[2]
[2] Transcript of Proceedings, Page 54, Line 14.
At no time during the presentations did Dr FA suggest a woman should undergo any screening procedures before embarking on a termination. Nor did she recommend the assistance or attendance of any other person, medically qualified or not.
The following opening statements from three of the sections of Dr FA’s instructions convey their tenor:
1.Understanding Medical/Pharmacological Termination of Pregnancy
I’d like to explain to you how you can undertake abortion quite safely in your own home using tablets that are freely available around the world…
2.Early first trimester termination
I will now explain to you the method of administering the Misoprostol and assume you do not have access to the Mifepristone or the Methotrexate…
3.Late first trimester termination
I will now explain to you the method of administering Misoprostol and assume you do not have access to the Mifepristone or the Methotrexate…
Dr FA submitted that she did provide information about what to expect, but it could not be said her information was sufficiently clear to a person without medical training.
A lay person would be reassured by Dr FA’s expertise, might not delve further into the detailed material linked to the site, and, if so, could not be expected to be able to interpret how that information might qualify Dr FA’s instructions.
The users of the website could well include teenage girls faced with an unwanted pregnancy and women whose first language is not English. The information makes no accommodation of the particular needs and vulnerabilities of those girls and women.
Dr FA gave specific doses for the drug Misoprostol, including the number of repeat doses that might be required, but did not explain how a woman might determine whether a repeat dose was required. Nor did she advise that the dosage should be determined and supervised medically. For example, in relation to second trimester termination Dr FA stated:
If employing the regime after 16 weeks, then it will consist of 5 doses. It is quite frequent after 16 weeks that it takes more than one administration of the Misoprostol. It may take 3 consecutive days of the tablets before the full effect is achieved. This does not happen if you are fortunate to be able to utilise Mifepristone in advance.
At an earlier point in her instructions, Dr FA advised that the highest success rates occurred when there was access to both Misoprostol and Mifepristone (also known as RU486 or the abortion pill). She advised the latter should be taken 24 to 48 hours before taking Misoprostol. She also advised Methotrexate was an alternative to Mifepristone, with very mild side effects, although it takes longer than Mifepristone to work. She did not suggest any medical advice was necessary in determining in what circumstances or in what doses to take those additional drugs.
Dr FA purported to educate the user to self assess whether a termination has been successful. For example, in relation to an early first trimester termination, she stated:
If there hasn’t be (sic) pain or bleeding as significant as a normal period, then that would be classified as a failure and the process would be repeated 4 to 7 days later.
The instructions contained very little information about how to recognise complications. For example, in relation to a late first trimester termination Dr FA stated:
After 10 weeks there is a lot more growth and tissue to deal with. There will be more tissue to pass and it will be accompanied by more blood, often with clots. The pain may be worse…
After 10 weeks and up to 16 weeks is the timeframe for abortion that probably has the highest chance of complication, because it has the highest chance of tissue being left behind in the uterus which then can become infected or cause haemorrhage.
She gave no useful guidance about what a lot more tissue or more blood meant. Dr FA did not advise what symptoms might indicate that tissue had been left in the uterus or what to do or where to seek assistance if a woman thought that some tissue did remain.
Dr FA gave no advice about arranging access to urgent care; 24 hour telephone advice; or arrangements for uterine evacuation, emergency care or appropriate follow up.
At no stage in her instructions did Dr FA recommend any sort of prior assessment of the woman’s health or the state or stage of her pregnancy, any consultation with a medical practitioner, or any medical supervision of the procedures she described.
She explained that a doctor’s prescription is required for Misoprostol but also that it might be purchased from pharmacies overseas, on the black market or through the internet.
The only post termination recommendation she made was to give immediate thought to contraception.
The detailed instructions given by Dr FA for self administered medical termination did not comply with the RANZCOG guideline. Providing links to that guideline, and others, without any attempt to translate their requirements, was not sufficient to fulfil her professional obligations.
(b)Did Dr FA provide instructions for medically unsupervised terminations which are unsafe in circumstances where she knew or ought to have known the procedure was unsafe?
Given the statements extracted above, it is beyond dispute that Dr FA provided instructions for medically unsupervised terminations. The remaining questions are whether medically unsupervised terminations are unsafe and whether Dr FA knew or ought to have known that.
In these proceedings, the Board did not argue that it was unprofessional conduct to supervise a medical termination on an outpatient basis.[3] Rather, its case was that it was unprofessional conduct for Dr FA to provide information about how to undertake a medical termination, at any stage of the pregnancy, without medical supervision.
[3]In earlier disciplinary proceedings against Dr FA, the former Health Practitioner Tribunal determined that a mid-trimester termination of pregnancy should be performed only on an inpatient basis in a hospital.
This is an important distinction, given evidence led by Dr FA about trials of outpatient medical terminations conducted in a number of countries. Those trials involved clinical supervision, including the selection of women who could participate in the trial and the availability of emergency care and follow up checks.
Dr Challis prepared a report and gave oral evidence about the procedures described on Dr FA’s website. He concluded that the practices advocated on the website were highly likely to result in a serious adverse outcome if put into practice.[4] In his view, all terminations need some level of medical supervision.[5]
[4]Report of Dr Challis (DEC-3 of the affidavit of Dr Challis).
[5]Transcript of Proceedings, Page 35, Line 20.
Dr Challis raised risk factors relevant for any termination of a pregnancy; as well as factors arising from the use of the drug regimes advocated by Dr FA: Misoprostol alone; a combination of Mifepristone and Misoprostol; and a combination of Methetrexate and Misoprostol.
Risk factors relevant to any termination
Dr Challis considered consultation and assessment was necessary prior to any termination, so the practitioner could assess and advise about a number of matters.
He said a practitioner should assess the patient’s psychological status and explore the reasons for termination.[6] They should screen for sexually transmitted diseases and counsel the patient about future contraceptive options.[7]
[6]Ibid, Line 21.
[7]Transcript of Proceedings, Page 35, Lines 23-25; Exhibit 36, RCOG, ‘The Care of Women Requesting Induced Abortion’ (2011) Recommendations 6.17, Page 55 and 6.20, Page 56.
He considers an ultrasound should be performed prior to all surgical terminations, and most medical terminations.[8] This can confirm and determine gestation[9], and will identify other underlying medical issues such as a bicornuate uterus (although this is rare), which may affect what termination procedure is used.[10]
[8]Transcript of Proceedings, Page 40, Lines 14-36.
[9]Ibid, Page 35, Lines 25-29 and Page 40, Line 16.
[10]Ibid, Page 40, Lines 27-30.
It is important to establish gestation, as patients frequently estimate this incorrectly. Gestation also has a bearing on whether a particular method of termination is appropriate.[11]
[11]Ibid, Page 40, Lines 18-21.
The patient’s blood group should be tested to ensure it is not rhesus negative. If it is, a rhesus prophylaxis must be administered within 72 hours of termination to avoid possible complications with future pregnancies, if the father is rhesus positive.[12] The risks to foetuses in such cases range from anaemia (at best) to foetal death (at worst).[13]
[12]Transcript of Proceedings, Page 35, Lines 35-37, Page 36 Lines 1-12.
[13]Ibid, Page 36, Lines 6-12.
Dr Challis described the importance of ruling out an ectopic pregnancy, one of the leading causes of maternal death in the developed world.[14]
[14]Ibid, Page 35, Lines 37-43.
Dr Challis also referred to complications that could occur during or after any termination. A retained placenta is a common complication of medical termination in the second trimester, and may occur in about 20% of women.[15] If the placenta is stuck in the cervix, the patient might require resuscitation, urgent transfer to an operating theatre and, sometimes.[16] He estimated a need for transfusion in about 10% of second trimester cases.[17] Because the risk of a retained placenta is so high in terminations, the hospital in which he works asks patients to sign a consent form for the surgical removal of the placenta or retained products of conception.[18]
[15]Ibid, Page 37, Lines 5-7.
[16]Ibid, Page 37, Line 19.
[17]Ibid, Page 37, Line 19.
[18]Ibid, Page 37, Lines 15-18.
A retained placenta can also cause problems in first trimester terminations. If tissue remains in the cervix of the uterus, this could result in cervical shock. Low blood pressure might lead a woman to collapse and require resuscitation.[19]
[19]Ibid, Page 43, Lines 15-18.
Another prominent risk of any medical termination is infection. One guideline recommends services should offer antibiotic prophylaxis for both surgical and medical termination.[20]
[20]Transcript of Proceedings, Page 43, Lines 20-26; Exhibit 36, RCOG, ‘The Care of Women Requesting Induced Abortion’ (2011) Recommendation 6.5, pg 53.
Other general side effects and complications of medical terminations include prolonged uterine bleeding when combined drug regimes are used (methotrexate/misoprostol and mifepristone/misoprostol)[21] and incomplete termination (all drug regimes).[22] Other side effects such as pain and cramping are generally tolerable.[23]
[21]Exhibit 33 Ibis Reproductive Health, ‘Medication Abortion-A Guide for Health Professionals’, Pages 10 (Paragraph 1), 14 (Paragraph 3).
[22]Ibid, Pages 10 (Paragraph 1), 14 (Paragraph 3) and 20 (2nd Significant Paragraph).
[23]Ibid, Page 27, Paragraph 1.
Risk factors arising from the use of the drug regimes advocated by Dr FA
If only Misoprostol is used, Dr Challis estimated the chance a termination would not occur is somewhere between 7% and 39%.[24] A layperson would find it difficult to determine whether the termination had been successful, because the presence of bleeding and passing blood clots might be misleading.[25]
[24]Affidavit of Catherine Miedeke, Exhibit CM 8, Page 40, Paragraph 2.
[25]Transcript of Proceedings, Page 38, Lines 27-32.
He did not agree with Dr FA’s dosage recommendations for Misoprostol. Dr FA instructed that 4 doses of Misoprostol should be used for first trimester terminations[26], and 5 doses of Misoprostol for second term terminations.[27] Dr Challis said, in his experience, some women required up to 15 doses of Misoprostol to achieve termination.[28] He estimated around 25% of women would fail to miscarry after taking the doses recommended by Dr FA in their first trimester[29] and around 15%-20% of women who took the doses recommended by Dr FA in their second trimester would fail to miscarry.[30]
[26]Affidavit of Catherine Miedeke, Exhibit CM 2, Pages 11-12.
[27]Affidavit of Catherine Miedeke, Exhibit CM 2, Page 14.
[28]Transcript of Proceedings, Page 37, Lines 40-41.
[29]Ibid, Page 38, Line 20.
[30]Ibid, Page 38, Lines 20-21.
If a termination is not completed, there is a risk that a foetus carried to term would suffer from Moebius syndrome (ie, severe foetal abnormalities).[31] Dr Challis said this has been observed in South American countries where the technique recommended by Dr FA is commonly used.[32]
[31]Affidavit of Catherine Miedeke, Exhibit CM 8, Page 40, Paragraph 3.
[32]Ibid.
Dr Challis expressed reservation about Dr FA’s recommendation of Methotrexate. Although it is a drug that is widely used, this occurs under close supervision.[33] He considers it is a very dangerous drug.[34] If the wrong dosage is taken, it could be fatal.[35]
[33]Transcript of Proceedings, Page 44, Lines 8-9.
[34]Ibid, Page 44, Line 12.
[35]Transcript of Proceedings, Page 44, Lines 12-15.
Evidence relevant to safety of outpatient medical termination led by Dr FA
Dr FA also led evidence that illustrated the risks of undertaking a medical termination as an outpatient without medical supervision.
Precluding conditions for taking Misoprostol alone include:
· an ectopic pregnancy;
· allergy to Misoprostol;
· presence of an intrauterine device;
· uterine infection;
· severe anaemia;
· cardiovascular and cerebrovascular disease;
· coagulopathy or current therapy with anticoagulants;
· hypertension;[36] and
· inflammatory bowel disease.[37]
[36]Exhibit 33, Ibis Reproductive Health, ‘Medication Abortion-A Guide for Health Professionals’ Page 20.
[37]Exhibit 34, Ibis Reproductive Health, ‘Medication Abortion-A Training Module for Health Professionals’, power point presentation, Page 6.
Precluding conditions for taking Mifepristone with Misoprostol include:
· confirmed or suspected ectopic pregnancy;
· allergy to either Mifepristone or Misoprostol;
· presence of an intrauterine device;
· chronic systemic use of corticosteroids;
· chronic adrenal failure;
· coagulopathy or current therapy with anticoagulants;
· inherited porphyria;[38] and
· women with chronic medical conditions including hypertension, severe hepatic or renal disease and severe anaemia should be evaluated separately.[39]
[38]Exhibit 34, Page 3.
[39]Exhibit 33, Page 8, Paragraph 4.
A regime of Methotrexate and Misoprostol is recommended for certain ectopic pregnancies.[40] However, precluding conditions for taking that regime include:
· allergy to either methotrexate or misoprostol;
· presence of an intrauterine device;
· coagulopathy;
· current severe anaemia;
· acute or chronic renal or hepatic disease;
· acute inflammatory bowel disease; and
· uncontrolled seizure disorders.[41]
[40]Ibid, Page 12, Paragraph 1.
[41]Ibid, Page 15, Paragraph 2.
Dr FA tendered reports of two studies that conclude that medical termination as an outpatient can be safe and effective. Both of these studies involved some level of medical supervision. Neither report advocated outpatient termination without any supervision at all.
One trial was reported in an article in ‘Contraception Online’. The author, Gonzalez, concluded that self administered vaginal Misoprostol at home in the second trimester is safe, effective and limits the time that a patient has to spend at hospital.[42] In this study, Misoprostol was issued to the subjects in hospital. Women with current maternal infection, pulmonary, hepatic, renal or cardiovascular disease were excluded, as were women with bleeding disorders.[43] Women who lived more than 30 minutes drive from the relevant hospital were also excluded.[44]
[42]Exhibit 30, Gonzalez, “Outpatient second trimester pregnancy termination”, Contraception Online, Page 7, Paragraph 2.
[43]Ibid, Page 2, Paragraph 1.
[44]Ibid.
In this group there were no severe haemorrhages (with severe being defined as being a loss of over 500ml). The author observed this might be because Misoprostol is an effective uterotonic agent that decreases the risk of post partum haemorrhage.[45] This study also suggested the risks of infection post termination may be lower at home than in a hospital ward.[46]
[45]Ibid, Page 6, Paragraph 1.
[46]Ibid, Page 6, Paragraph 5.
Similar conclusions were drawn by Fiala et al in their study “Acceptability of home-use of misoprostol in medical abortion”.[47] In this study, the subjects were given the option of having Mifepristone at hospital and then administering Misoprostol at home.[48] There were a number of checks of women who chose home use. Their gestational age was established.[49]
[47]Exhibit 49, Fiala et al “Acceptability of home-use of misoprostol in medical abortion” 70 Contraception 387.
[48]Ibid, Page 388, Column 2, 1st Significant Paragraph.
[49]Ibid.
In order to be accepted for the trial, the women could not have any contraindication for medical termination, such as abnormal pregnancy, a contraindication to Mifepristone or Misoprostol, or signs of genital infection.[50]
[50]Ibid.
They had to be above the age of 18, had to live within one hour’s drive from the hospital and had to be willing to co-operate with the requirements of the study.[51]
[51]Ibid.
The patients received the Mifepristone in the hospital, but were issued with Misoprostol, and analgesics to take home.[52] In this study, two of the women required a vacuum aspiration due to an incomplete abortion.[53] None of the women required a blood transfusion for a serious haemorrhage.[54] There was one adverse effect in a woman with a deep venous thrombosis. This was found to be related to the pregnancy rather than the treatment.[55] The authors considered the risk of acute haemorrhage was rare, occurring in less than 1 in 500 subjects.[56] Ultimately, the authors considered the study confirmed the safety, efficacy and acceptability of Misoprostol use at home.[57] Although the study supported greater autonomy for woman in the decision about where the termination should take place, it did not advocate there need be no medical supervision of the procedure.
[52]Ibid, Column 2, Paragraph 2.
[53]Ibid, Column 1, Paragraph 5.
[54]Ibid, Column 1, Paragraph 6.
[55]Ibid.
[56]Ibid, Column 1, Paragraph 2.
[57]Ibid, Page 391, Column 2, Paragraph 2.
Dr Challis expressed the view that outpatient terminations were not necessary in a country which provides the level of access and care available in Australia.[58] That is a matter of opinion on which reasonable minds might differ. In the Fiala article, the authors say the practice of giving women the Misoprostol to take at home had been adopted as a clinical routine in the US.[59]
[58]Transcript of Proceedings (Medical Board and Dr FA), Pages 33, Line 46-47 and Pg 34, Lines 1-7.
[59]Exhibit 49, Page 388, Column 2, Paragraph 2.
However, the studies relied on by Dr FA screened patients for factors or conditions that might present particular risks and they were required to be within easy reach of the hospital for emergency care. Even after screening for risk factors, in the second of the two studies referred to, a few women required further medical attention.
While the studies suggest that outpatient medical termination with some level of medical supervision may be safe for patients selected to exclude common risk factors, they do not establish that medical termination without any medical supervision is safe. As these studies were tendered by Dr FA, and were published well before Dr FA established her website, it is reasonable to assume that she was aware of them when did so.
(c)Did the material fail to appropriately warn users of the risks of medically unsupervised terminations of pregnancy?
This question can be dealt with briefly. Dr FA may well have provided links from her website to documents that contained information about the risks of a medical termination. One page of the website referred to case study results. Another referred to professional guidelines and World Health Organisation information sheets. Because Dr FA did not specify what documents were accessible through these links it is not possible to assess what risks might have been covered.
In any case, providing links to documents, without identifying how they might assist the reader or what protocols or risks are discussed in them, is not adequate to counter the strong impression that Dr FA created in her detailed instructions that the procedures are safe. Dr FA had no control over the audience for her website. It is reasonable to assume the domain name safehomeabortion could attract the attention of teenage girls facing unplanned pregnancies. The potential audience would also include women with limited access to medical advice and support, whether because they are isolated, physically or socially, lack means to secure medical treatment or are reluctant to seek advice for cultural or other reasons.
Dr FA did not recommend any of the prior screening procedures referred to in Dr Challis’ evidence or undertaken in the trials relied upon by Dr FA. She did not identify any of the contraindications for medical terminations or the use of any of the drugs she recommended. She did not identify the potential complications of a termination, other than a retained placenta or a haemorrhage. She did not explain how to assess whether those or other risks had materialised or what to do about them. She did not recommend any follow up health checks. She did not recommend arrangements for emergency advice or treatment.
In short, Dr FA failed to adequately warn of the risks of medical terminations or what steps a woman might take to avoid, ameliorate or respond to those risks.
(d)Did the website provide advice to users as to how to obtain Misoprostal without a lawful prescription, including over the internet?
Misoprostol is listed as a Schedule 4 drug on the Poisons Standard 2010 (Cth).[60] As a result, in Queensland it is a restricted drug which must only be dispensed under prescription.[61]
[60] Promulgated under the Therapeutic Goods Act 1989 (Cth), s 52D.
[61] Health (Drugs and Poisons) Regulation 1996, regulations 190 and 193.
On the website, Dr FA acknowledged that Misoprostol might need to be procured illegally.[62] She said:
Overseas, Misoprostol may be purchased at pharmacies and, of course, on the black market. Take care with your source. Women on Waves may oblige via the internet.
[62] Affidavit of Catherine Miedeke, Exhibit CM 2, Page 12, Paragraph 9.
Dr Challis expressed the view that it is unprofessional for a doctor to advocate to women that they might obtain Misoprostol illegally from abroad, if their doctor is unwilling to prescribe it.[63]
[63] Affidavit of Dr Daniel Challace, Exhibit DEC 3, Page 2, Paragraph 1.
By providing a potential source for the drug online, Dr FA undermined regulations designed to restrict access to such drugs in Australia. It is no answer that a person could learn this through other sources on the internet.
Dr FA is not alone in advocating for more liberal access in Australia to drugs used in medical terminations. Other medical practitioners have strongly argued for law reform and easier access to the drug Mifepristone (commonly referred to as RU486). Advocating liberalisation of access is a different matter to advising persons on how they might obtain them illegally.
Dr FA failed to adequately warn users of the website of the risks of procuring a drug on the black market. Although she said to take care with the source, she did not explain why or how to assess the reliability of a source.
The efficacy and safety of drugs available on the black market is something others advocating medical termination have cautioned about. For example, Dr FA tendered an item by the International Consortium for Medical Abortion, which advises caution in attempts to procure Misoprostol on the black market, warning the drugs purchased may be counterfeit, ineffective or more expensive than they should be.[64]
[64] Exhibit 5, ICMA Statement on Misoprostol 2009.
Another of Dr FA’s documents was a note of an article from the United Kingdom expressing concerns about the legitimacy of drugs marketed as Misoprostol.[65]
[65]Exhibit 39. “UK: Media Fears about Women Buying Abortion Drugs Online” Abortion Review, Issue 35 2011 Page 6, Column 1, Line 5.
(e)Did Dr FA advocate and promote the website in the media?
Dr FA participated in media interviews which resulted in her being quoted in newspaper articles.[66]
[66]The details of which are suppressed in accordance with the Tribunal’s order 4 made on 21 December 2012.
The first article appeared on the day the website was launched.
The author attributed a statement to Dr FA.
Quite clearly that article advocates and promotes the website.
Some months later, a second article published a lengthy profile of Dr FA and her views regarding access to medical terminations. The focus of the article was the case which led to the earlier disciplinary proceedings against Dr FA. It gave little prominence to the website, which was referred to only towards the end of the article. The author noted Dr FA had voluntarily taken down the website and reported that Dr FA said she had done so only temporarily while a complaint from RANZCOG, presumably the one that initiated these proceedings, was investigated.
Although the second article referred to the website, the Tribunal is not satisfied that, in it, Dr FA advocated or promoted the website, which was then inactive.
Does Dr FA’s conduct constitute a ground for taking disciplinary action?
The Board referred this matter to the Tribunal pursuant to s 193 of the Health Practitioner Regulation National Law (Queensland). It seeks a finding that Dr FA engaged in professional misconduct or unprofessional conduct by publishing the website for the reasons explored above. At the core of its case is the Board’s assertion that Dr FA’s conduct posed a real safety risk to members of the public. Dr Challis considered that, had Dr FA’s instructions been followed, there could have been serious consequences. Dr Challis’s uncontested evidence was supported by some of the material led by Dr FA.
Despite the disclaimer on the website and Dr FA’s statement to the Board,[67] it is clear from the content of the website itself, and what Dr FA said about it in the article published on the day it was launched, that she intended it to be a direct source of instruction to women about how to undertake a medical termination in their home without supervision.
[67] Affidavit of Catherine Miedeke, Exhibit CM 5.
Her instructions did not comply with the RANZCOG guidelines about the safety mechanisms for a medical termination. Dr FA’s website did not adequately draw the website user’s attention to the risks of the procedures she described or what they might do to deal with those risks. Dr FA advised her readers about how to secure Misoprostol illegally.
The definition of professional misconduct, of a registered health practitioner, includes—
(a) unprofessional conduct by the practitioner that amounts to conduct that is substantially below the standard reasonably expected of a registered health practitioner of an equivalent level of training or experience; and
(b) more than one instance of unprofessional conduct that, when considered together, amounts to conduct that is substantially below the standard reasonably expected of a registered health practitioner of an equivalent level of training or experience; and
(c) conduct of the practitioner, whether occurring in connection with the practice of the health practitioner’s profession or not, that is inconsistent with the practitioner being a fit and proper person to hold registration in the profession.[68]
[68]Health Practitioner Regulation National Law Act 2009, Schedule, s 5, definition of “professional misconduct’.
The Board has not mounted an argument that the conduct qualifies under paragraphs (b) or (c). To be professional misconduct, then, the Tribunal must decide Dr FA’s conduct is substantially below the standard reasonably expected of an equivalently trained and experienced practitioner.
The Tribunal is not persuaded it is substantially below the standard for a number of reasons. Firstly, it accepts Dr FA’s motivation was well intentioned, albeit seriously misguided, when considered in the context of her ideological position about increasing the access of women to termination services. There is no suggestion that Dr FA intended harm, rather that she hoped this would raise the profile of an issue about which she feels passionately. That said, Dr FA gave different explanations at different times about why she established the website. To the Board she said her primary purpose was to educate practitioners.[69] In her interview with the media she said that she wished to get information out to women in rural or remote locations.[70] To the Tribunal, she put the website in the context of a presentation she proposed to make to her professional peers.[71] These somewhat shifting explanations cause the Tribunal to question exactly what Dr FA’s purpose was in establishing the website.
[69] Affidavit of Catherine Miedeke, Exhibit CM 5.
[70] Affidavit of Catherine Miedeke, Exhibit CM 1.
[71] Transcript of Proceedings, Page 52, Lines 5-12.
Secondly, Dr FA took only limited steps to promote the website to the public. She disabled the website when the Board asked her to. Although she declined to give the Board an undertaking that she would not do this again, her reluctance to give that undertaking is consistent with her ideological position. Although this suggests she lacks insight about the potential risks arising from her conduct, this is a matter for sanction, rather than the nature of the disciplinary offence.
The Tribunal finds Dr FA’s conduct is unprofessional conduct. That is professional conduct that is of a lesser standard than might reasonably be expected of her by the public or her professional peers, and includes influencing, or attempting to influence, the conduct of other registered health practitioners in a way that may compromise patient care.[72] Finding on that specific basis is open, given Dr FA’s submission that the website was intended to educate other practitioners.
[72]Health Practitioner Regulation National Law Act 2009, Schedule, s 5, definition of “unprofessional conduct”.
Sanction hearing
In their final submissions, both parties requested an oral hearing on sanction. There will be a lengthy delay (until mid September) before the Tribunal can reconstitute, due to the limited availability of the presiding member and assessors. The Board is content for the question of sanction to be determined on the papers. Dr FA has not withdrawn her request for an oral hearing on sanction. At this point, she has not filed any material relevant to sanction. There is no particular urgency about determining the sanction. The Board is not seeking an order that would prevent Dr FA from continuing to practise. In those circumstances, the matter will be listed for an oral hearing on a date to be advised by the Registrar after consultation with the parties. Should either party seek directions for filing material before the hearing, they must consult with the other before approaching the Tribunal for directions to be made.
Reasons for rejecting Dr FA’s assertion that the Board did not lead all the information accessible on the website
At [12] in these reasons, the Tribunal rejected Dr FA’s suggestion that the Board had misrepresented the material accessible on the website. The reasons for that decision follow.
It is troubling that Dr FA made this assertion at such a late stage of the proceedings. The hearing proceeded with interruptions occasioned by Dr FA’s late introduction of evidence. The oral hearing, which commenced in February, was adjourned so Dr FA could put before the Tribunal all documents she considered relevant. She then provided different sets of documents to the Tribunal and to the Board. The Tribunal did its best to identify all documents provided by the extended deadline, and gave written reasons for its decision about what would and would not be admitted into evidence. Dr FA did not avail herself of the opportunities the Tribunal gave her to identify why any of the documents she provided to either the Tribunal or the Board were relevant. The Tribunal has had to try to assess Dr FA’s material with no assistance from her.
When the oral hearing resumed, she arrived late and did not return after the lunch adjournment, which resulted in the matter concluding on the papers. In the time she attended the resumed hearing, she did not identify any of the documents admitted into evidence as being documents that had been displayed or had been accessible through the website. Nor did she assert that any that the Tribunal had not admitted had been displayed or had been accessible on the website.
It is extraordinary that in her written submissions she would allege, for the first time, that the Board did not tender all the material accessible on the website, either because it did not have access to it or because it had manipulated the case against her.
Even in those submissions, she has not identified, except in the most general of terms, what further information was accessible through the website. Nor has she explained how the unspecified further material could have been accessed when the website was live, or how the guidelines and other information could have qualified or supplemented the website material tendered by the Board.
Although Dr FA is representing herself, she is highly intelligent and has past experience in disciplinary proceedings. The Tribunal was at pains to explain repeatedly both what the proceedings were about and the importance of clarifying her position and any evidence she wished to produce in response to the Board’s allegations. Steps taken before the resumed hearing are described in more detail in the Tribunal’s decision in Medical Board of Australia v Dr FA [2012] QCAT 110.
The Tribunal cannot accept Dr FA’s late assertion that other (unspecified) relevant material was displayed on the website that would affect the view the Tribunal should take of the website as a whole. There is simply no evidence before the Tribunal that would allow it to do so. The Tribunal has made this decision, therefore, on the only evidence available to it about the information accessible on the website; which is the form in which it was tendered by the Board.