ACCC v Homeopathy Plus 21st November 2013 – Sheffield evidence.

This is Part 4 of a series Part 1 can be found here, Part 2 can be found here and Part 3 can be found here.

I must give a big shout out to Carolyn Bond for the notes from the last day’s proceedings. I was unable to attend and she stepped into the fray for me. I would also like to acknowledge Carolyn’s help in proof reading and editing my previous posts and her spouse for his legal advice and review. Follow her on Twitter for all things consumerish & some humour.

Ms Sheffield was cross examined in the witness stand on her written evidence by Ms Higgins for the ACCC. Prior to that, her own barrister, Mr White went through a number of annexures to her affidavit to gain agreement from ACCC counsel that they can be relied upon to prove the existence of the articles, their titles and subject matter BUT not as evidence of the efficacy of homeopathic remedies.

The reason that Ms Sheffield was cross examined is because her written evidence or affidavit is considered her evidence. Therefore questioning by ACCC is considered cross examination. Not like TV legal dramas at all. Not a hint of shoutiness.

We don’t have access to her affidavit so it would be advisable to also rely on the judgment for more information on the content of her written evidence.

ACCC put a considerable amount of focus in questioning Ms Sheffield about links on her website and whether the articles link to sales of products.  I am reliably informed that a key issue in this case was whether or not the statements were made “in trade or commerce”.  The prohibition on misleading and deceptive statements in the Australian Consumer Law doesn’t apply unless the statement is made “in trade or commerce”. There have been many cases where the exact meaning of this phrase has been considered (see  Section 8 of judgment).  The word “in” is important here, because the law doesn’t apply to all statements made by, or in relation to, a business.  However, if the statements are aimed at customers or potential customers of a business, and play a role in persuading people to use the goods/services provided, then they are likely to be found to be made “in trade or commerce”.  In some cases a person could be found guilty of a breach even if they are not the business or business owner (for examole an employee).

ACCC proceeded to question Ms Sheffield in detail about the three articles referred to in the judgment. She was asked about her sources and references and whether she may have misused her sources and references. The ACCC pointed out a number of instances where she had cherry picked from her references – quoting from one part but not mentioning important clarifications and conclusions. One example was from a radio interview where Ms Sheffield quoted a statement from an expert relating to a reduction in the effectiveness of the pertussis vaccine. This reduction was attributed in part due to a change in the pertussis strain but Ms Sheffield failed to mention that the interviewee qualified this by saying that vaccination still had a significant protective effect. Ms Sheffield admitted that she didn’t refer to some parts because she didn’t agree with them.

Ms Sheffield was then asked about her statement “side effects are common” in relation to the pertussis vaccine and have a “long history of side effects”.  Ms Sheffield took this part of her evidence from an article by Meryl Dorey called Pertussis: the Fear Factor  Ms Dorey was President of the now discredited Australian Vaccination Sceptic Network at the time that she wrote that article. Ms Sheffield indicated that she was also referring to the manufacturer’s own statements. What Ms Sheffield referred to is what the anti-vaccination groups call the “package insert” but what doctors and pharmacists call Product Information or PI. The PI is aimed at health professionals who know what they are reading and can put the information into perspective.  Ms Sheffield conceded that The Dorey article didn’t actually state the occurrence of side effects and that the side effects list that she relied on from those sources were actually potential side effects and don’t indicate occurrence at all.

Ms Sheffield was asked if she is anti vaccination. She said that no, she wasn’t, she was pro – homeopathy. It was put to her that there were no pro vaccination references in any of her articles. She disagreed, saying that the fact that she referred to homeoprophylaxis as a second line of defence is “acknowledgement of vaccine use and that I recognise that vaccination may have already been given.”. Interestingly, Ms Sheffield has previously criticised Meryl Dorey of dishonesty over her anti-vaccination denials and “pro-choice”claims.

It was apparent that Ms Sheffield was a true believer.  Some statements that she made while in the witness stand were:

“I’d like to see the public better protected by homeopathy.” and
“Sometimes I think I’m the only person who can see it.” and
“I would like to see the government provide free homeopathic treatments to the public.

The court adjourned for lunch given that all witness testimony had been heard.  I should point out that the judgment mentions Dr Jurgen Schulte who was presented as part of Homeopathy Plus’s expert evidence. I don’t remember being in court for this and neither does Carolyn but Dr Schulte’s affidavit was excluded in its entirety on the grounds of relevance. I can only assume that is because he has no background in health or medicine and no specific knowledge of pertussis. When I googled him I found that he is a Lecturer in the School of Physics and Advanced Materials. I have no idea why somebody with that background would be considered an expert witness in a case about homeopathy and pertussis vaccination.

The next part in this series will deal with the summations by counsel for both parties.

Links:

ACCC v Homeopathy Plus full judgment

Pertussis: The Fear Factor by Meryl Dorey

Public statement – warning about the Australian Vaccination-sceptics Network, Inc. (AVN)

Product Information Infrarix

Fran Sheffield declares the Australian Vaccination Network  “anti-vaccine”

 DISCLAIMER: This post contains personal views and reflections about the case and the hearing. It should not be relied upon as legal opinion.

 

ACCC v Homeopathy Plus 20th November 2013

This is Part 3 of a 4 part blog.

 Part 1 can be found here and Part 2 can be found here

I’ve just come across a copy of Professor Ken Harvey’s original complaint which also includes screenshots of the  First Whooping Cough Article that were the basis of the complaint.

Wednesday 20th September 2013 Ms Sheffield was delayed by a glitch with the  trains. While we waited for her, Justice Perry and counsel addressed administrative issues. The court was informed that Dr Golden would not be available to appear via video link until the afternoon. Justice Perry reminded Mr White (for HP) that the video was booked for 30 to 45 minutes and if it was any longer it would cost more. I think this was a veiled reference to his 10 minute opening address that took more than 45 minutes yesterday. Ms Sheffield and her daughter arrived.  Discussion then continued from yesterday about the admissibility of Dr Golden’s affidavit as expert opinion.  Justice Perry announced that she would take a 10 minute adjournment to rule on objections by Ms Higgins (for ACCC) to Dr Golden’s affidavit. Justice Perry came back with three findings

  1. Dr Golden’s affidavit does not contain evidence of effectiveness of homeopathy therefore his admissibility as an expert is denied.
  2. All of the  parts of Dr Golden’s affidavit objected to by ACCC were excluded (including Appendix E).
  3. HP can’t complain about the excess scrutiny of Dr Golden’s affidavit as he was afforded the same opportunity with ACCC experts but declined to use that opportunity.

Mr White appeared quite disheartened with Justice Perry’s ruling. Large chunks of Dr Golden’s affidavit were then redacted by mutual agreement by both parties. Mr White then protested  that he hadn’t had time to review all of the objections by ACCC as he didn’t receive them until 3.45pm on the previous Thursday. Because most of Dr Golden’s evidence was now on shaky ground Mr White asked Judge Perry for an adjournment to consider Waiver of Rules of Evidence based on Section 190 3(b) . ACCC objected strenuously and said that HP should have ensured that his evidence met the required standards before sending it to her and that by not doing so, he failed to meet his legal obligations. Judge Perry said she would take a 20 minute adjournment to rule on HP’s request for a waiver. The adjournment actually took over an hour and Mr White looked worried. Judge Perry denied waiver of rules of evidence saying

  1. ACCC gave plenty of notice to Mr White of the scope of objections.
  2. That Mr White should have foreseen the deficiency of evidence and therefore the number of objections raised by the ACCC to the evidence shouldn’t have come as a surprise.
  3. If Mr White didn’t think that he had time to deal with the number of objections and repair his client’s evidence he should’ve contacted the court and asked for the trial date to be vacated.

For more information regarding evidence see Section 3 of the judgment Dr Golden appeared via video link looking quite pleased with himself and wearing a colourful Bukharan yarmulke.  Ms Higgins introduced herself to him and explained to him  that most of his evidence had been excluded. She explained that he would only be able to answer the questions that she put to him and that no additional information would be accepted. Dr Golden didn’t look happy or comfortable with this information. Ms Higgins verified that Dr Golden had a copy of his affidavit. Her first question to him was why he didn’t annex all of his references in his affidavit, to which he responded that he didn’t know that he had to. This guy claims to be an academic. Ms Higgins suggested that Dr Golden deliberately omitted major conclusions from his references. He was then asked if the reason he didn’t annex all of his references was because it wouldn’t have reflected the basis of his affidavit. He very indignantlly responded “Not at all!” Mr White declined to ask any questions of Dr Golden and he was excused.  His testimony was completed in about five minutes. Dr Mark Donohue’s affidavit as an expert opinion was then introduced. Ms Higgins began going through her objections to his affidavit. Justice Perry asked on what basis is he an expert given that his CV hadn’t been updated since 2003! Mr White responded that he was a General Practitioner who had treated many case of pertussis.  Justice Perry asked if he was still practising, Mr White wasn’t sure. Ms Higgins commented that Dr Donohoe’s affidavit didn’t really present any evidence and was more in the form of an essay. Mr White looked embarrassed. Ms Higgins protested that Dr Donohoe’s affidavit had a list of more than 50 references without any context.  I think that’s what we in the skeptic game call ‘gish gallop‘. Mr White again cried unfair at the level of scrutiny that his witnesses were subjected to. Everyone just looked at him as if to say “Really? You’re going there again?”. Mr White then asked Justice Perry if Dr Donohoe’s affidavit could be excluded in total and for him not to be called as an expert witness to give testimony citing cost as an issue.  Justice Perry gravely warned Mr White that his client was facing very serious charges and that it may not be in her best interests to dismiss one of their expert witnesses without consulting Ms Sheffield first. She then asked Mr White if he would like a short adjournment to consult with his client to which he agreed. I am not a lawyer, but Justice Perry seemed to go out of her way to ensure that Ms Sheffield was given the opportunity to present her best case. This was extremely difficult for Mr White to do given the dearth of valid evidence and opinion to support the case. Mr White returned from the adjournment to announce that Dr Donohoe would not be called as an expert witness but that they would still like to submit his affidavit subject to ACCC’s objections. Ms Higgins then continued to scrutinise Dr Donohoe’s affidavit. Part of his affidavit were five articles from New Scientist magazine without any context or reference. Ms Higgins argued that submitting magazine articles without supporting evidence constituted hearsay and couldn’t be accepted. Justice Perry agreed.  Court was then adjourned until the following morning. After reading Justice Perry’s judgment, its apparent that the only remnants of Dr Donohoe’s affidavit left, supported the case for ACCC. (Section 3, Paragraph 24) “Insofar as his evidence was admitted, Dr Donohoe’s evidence was largely consistent with that given by the experts called by the ACCC, as I later explain.”  Links: Professor Ken Harvey’s complaint to ACCC ACCC v Homeopathy Plus judgment DISCLAIMER: This post contains personal views and reflections about the case and the hearing. It should not be relied upon as legal opinion.

ACCC v Homeopathy Plus – 18th and 19th November 2013

This part 2 of a 4 part blog. Part 1 is here

FEDERAL COURT NOVEMBER 2013

18th November 2013

 

The barrister appearing for Homeopathy Plus and Ms Sheffield was Mr Marcel White who also represented Australian Vaccination Sceptics Network (AVSN) in their unsuccessful attempt to have a direction by NSW Fair Trading to change their name overturned. The barrister appearing for ACCC was Ms R Higgins.

I wasn’t in court to keep a record of proceedings on Monday 18th November 2013.  My understanding is that The Applicant – ACCC commenced presenting their case.  Expert witnesses who gave evidence on that day were:

  • Dr Nigel William Crawford, Medical Head of Immunisation Services (which recommends and administers vaccines to high-risk children, including whooping cough, according to the schedule) and a Paediatrician at the Royal Children’s Hospital in Melbourne; and
  • Professor Kerryn Phelps AM, General Practitioner, who was the President of the Australian Medical Association from 2000-2003, and the President of the Australasian Integrative Medicine Association from 2009-2012.

Their evidence is referred to many times in the judgment

 

19th November 2013

Dr Nicholas Wood is a paediatrician at Westmead Childrens Hospital and appeared as an expert witness on behalf of ACCC. He was asked by ACCC to explain his role and that of National Centre for Immunisation Research and Surveillance (NCIRS). He outlined how NCIRS is funded and its role in surveillance as well as clinical and social research. Ms Sheffield appeared quite interested in the scope of work conducted by NCIRS.

Dr Wood explained in great detail his knowledge of pertussis and the pertussis vaccine.   In response to Mr White’s questions about the “short lived” action of  the pertussis vaccine, Dr Wood explained that the term “short lived” isn’t an accurate description but ‘waning levels of protection over time’ would be. He also explained that the National Immunisation Schedule is designed to minimise waning levels of immunity.  The other aspect of protection as explained by Dr Wood is that of herd immunity that prevents exposure to the disease.  He was then asked by Mr White to explain the “vaccine paradox”.
vaccine paradox.

Dr Wood very clearly explained the complex issue of “vaccine paradox” in lay terms as when the percentage of vaccinated and unvaccinated who will contract a disease is constant, the actual numbers in each category will change according to the percentage vaccinated. Mr White responded to Dr Wood with “So you admit that the majority of vaccine preventable diseases are in the vaccinated!”. It was about then that a sneaking suspicion came over me that Homeopathy Plus might not have much of a case. Dr Wood was then excused. I’m fairly certain Ms Sheffield learnt more that morning about vaccination than she had ever known before.

HOMEOPATHY PLUS’S CASE

The afternoon’s proceedings began with Justice Perry asking Mr White if he would like to make an opening address or rely on his submission. Mr White responded that he’d like to make a short 10 minute address (which actually took 45 minutes).  Mr White said that Homeopathy Plus’s case consisted of five main questions that need to be answered:

  1. Were Homeopathy Plus’s statements about pertussis made  ‘in trade and commerce’? Homeopathy Plus says no but the ACCC says yes (more on that later).
  2. Are vaccine representations (referring to Homeopathy Plus’s claims about the pertussis vaccine) covered by the Australian Consumer Law? Mr White tried to make the claim that because they are part of a wider public policy debate they are not. I thought this was rather a spurious claim because just about everything can be found to be part of a much larger policy debate. As the decision shows, this IS a spurious claim because misleading and deceptive conduct “in trade and commerce” is prohibited, regardless if its part of a public debate or not.
  3. Can vaccine statements be found to be misleading and deceptive? Mr White claimed  that they can’t be for the same reason as #2.
  4. If a contravention order were found, would that have a stifling effect on other natural therapies? – I found this line of argument as convincing as the argument that Mr White put during the AVSN hearings that they shouldn’t have to change their name because it would be inconvenient.
  5. If the court finds that they are indeed “trade and commerce” should they need the same level of verification if they are part of a public debate? See #2.

What is expert opinion?

As part of their case Homeopathy Plus submitted an affidavit from Dr Isaac Golden as an expert opinion.  Ms Higgins objected to large parts of Dr Golden’s affidavit on the basis of generality, ambiguity and that it was argumentative, and lacked foundation. Justice Perry also expressed concern at the quality (or lack) of most of Homeopathy Plus’s supporting evidence as submitted in affidavits and said she didn’t want to pre-empt her consideration but if a contravention is found, the quality of evidence may inform the penalty.  She said that the factual basis and reasoning by which an expert reaches conclusions must be exposed for the court to be able to give any weight to expert opinion and referred to the High Court ruling about Dasreef which is the leading case regarding what constitutes expert opinion.

Mr White argued that Dr Golden’s affidavit should be given weight as an expert, because he has spoken at many conferences (yes really).  Justice Perry again referred to Dasreef and noted that she found it puzzling that Dr Golden frequently referenced his own research. Ms Higgins objected to the entire content of Appendix E of Dr Golden’s affidavit because it mostly referred to his own website and book. Mr White then complained that Dr Golden’s affidavit was subject to a far greater level of scrutiny than any of the ACCC’s expert witnesses. This was followed by an awkward silence when everyone seemed to find something else that was suddenly interesting to look at. Mr White pushed it a bit further and said medical science shouldn’t be given preference over the paradigm of homeopathy.  Ms Higgins responded that 200 years of history was not a foundation of expertise when the fallacious reasoning is exposed.  Ms Sheffield looked crestfallen when she heard that, while I was silently cheering.

I didn’t have access to any of the submissions or affidavits because I wasn’t part of the proceedings but simply an observer.

The day ended with Justice Perry saying she will rule on Appendix E of Dr Golden’s affidavit tomorrow.

Links:

Australian Vaccination Network Inc v Department of Finance & Services [2013] NSWADT 266

National Immunisation Program Schedule 

Dasreef Pty Ltd v Hawchar (2011) HCA – expert reports

Disclaimer: This post contains personal views and reflections about the case and the hearing. It should not be relied upon as legal opinion.

ACCC v Homeopathy Plus – Background

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A regulatory prosecution issued by the Australian Competition and Consumer Commission (ACCC) against Homeopathy Plus, resulted in a four day trial in November 2013.   It was held in the Federal Court in Sydney, Australia and was presided over by Justice Melissa Perry. The trial ran from Monday 18th November to Thursday 21st November 2013. Homeopathy Plus – as well as Ms Fran Sheffield personally were charged with engaging in misleading and deceptive conduct by ACCC according to section 18 of the Australian Consumer Law (ACL) and of making false or misleading representations in contravention of sections 29(1)(a) and (b) of the ACL.

On Monday 22nd December 2014, those charges were found to be proven in a decision handed down by Justice Perry. The full judgement was published online on Wednesday 24th December. A directions hearing has been set down for Wednesday 4th February 2015 on the question of penalties.

I was in the courtroom on 19th and 20th November 2013 and my friend Carolyn Bond was there for the final day 21st November 2013. We were the only two members of public in court who kept notes of some of the proceedings. While the decision [see link] details the key arguments and evidence, I thought some people may be interested to read some of our observations and reflections of the court process and the arguments and evidence as presented.

Of course, this post contains personal views and reflections about the case and the hearing. It should not be relied upon as legal opinion.

BACKGROUND

Fran Sheffield is a former Registered Nurse who at some stage discarded all of her medical knowledge and became a homeopath. As far back as 2010 Ms Sheffield and her business Homeopathy Plus have been the subject of complaints, investigations and adverse findings by regulatory bodies. Most of these have centred around her claims that homeopathic vaccines (homeoprophylaxis) are a safe and effective alternative to orthodox vaccines.

Most of these complaints have come from Professor Ken Harvey a committed and passionate health consumer advocate. This particular case dates back to 2011 when Therapeutic Goods Administration (TGA) found that Homeopathy Plus! had breached several sections of the TGA Advertising Code and was ordered to post a retraction on her website. But Ms Sheffield refused to post the retraction saying that she wasn’t advertising but providing information.

In April 2012 the Australian Competition and Consumer Commission (ACCC) initiated an investigation into similar claims as those investigated by the TGA about information on the Homeopathy Plus website.  Ms Sheffield was asked by ACCC to remove an article from her website that claimed that the pertussis vaccine was “no longer effective” and “short lived and unreliable”. That article is referred to in the judgment as First Whooping Cough Article. Ms Sheffield complied with that request but then reposted the article later that year in a revised version which is referred to in the judgment as Second Whooping Cough Article.

In February 2013, Ms Sheffield posted on her website that the ACCC advised her that content on the Homeopathy Plus  website was potentially misleading and deceptive. She was also advised that if she accepted liablility and agreed to the orders made by the ACCC that the matter could be settled by mutual consent. Ms Sheffield refused that course of action because she believed the information she supplied was correct. As a result, that matter went to the Federal Court.

Links: 

TGA – Homeopathy Plus complaint 2011/05/004

A letter from Fran Sheffield

ACCC takes legal action over homeopathy claims

ACCC v Homeopathy Plus Order

ACCC v Homeopathy Plus Full Judgement

DISCLAIMER: This post contains personal views and reflections about the case and the hearing. It should not be relied upon as legal opinion.