NRM's contentions relating to the word "efficacy" in paragraph 9(c)(i)
64 NRM contended that the word "efficacy" is not "clear and unambiguous". Alternatively, it contended that items 4 to 20 are not statements as to the efficacy of NRM treatments (it concedes that, if the order is capable of having any effect at all, items 1 to 3 are statements as to efficacy).
65 In support of the contention that the word "efficacy" is not "clear and unambiguous", NRM points to the ACCC's submissions on the present application. In those submissions, the ACCC cites two dictionary definitions of the word "efficacy" (namely, "power or capacity to produce effects; power to effect the object intended", from the Oxford English Dictionary, and "the capacity for serving to product effects", from the Macquarie Dictionary) and then submits that the meaning of "efficacy" in the present context "includes the possibility of, or potential to, bring about a result". NRM contends that to hold out the mere possibility of a result is a very different thing to holding out the capacity to deliver a result, and that this demonstrates that the word is ambiguous.
66 In my view, the word "efficacy" is clear and unambiguous. It has its ordinary meaning when used in paragraph 9(c)(i) of the April 2015 orders which is conveyed by the definition appearing in the Macquarie Dictionary (6th ed, 2013): "capacity for serving to produce effects; effectiveness". That the word bears its ordinary meaning is supported by the immediate context in which it is used in paragraph 9(c)(i), namely in connection with "NRM treatments". This expression is defined in paragraph 4 of the April 2015 orders as medications and medical services for the treatment of male sexual dysfunction. It is natural and logical to speak of the effectiveness of medications and medical treatments, or the capacity of medications and medical treatments for serving to produce effects, suggesting that "efficacy" does have its ordinary meaning in paragraph 9(c)(i). The word "efficacy" is also used in other paragraphs of the April 2015 orders in connection with medications and medical treatments: see paragraphs 1(d)(ii)(B), 4(d)(ii)(B) and 8(f) of the orders. It seems to me that "efficacy" also has its ordinary meaning in those paragraphs and thus has a consistent meaning throughout the orders.
67 In my view, it is not necessary to have regard to the Reasons in order to determine that the word "efficacy" has its ordinary meaning. But if regard is had to the Reasons, they confirm that "efficacy" is used in this sense. The Reasons contain extensive discussion of the efficacy or effectiveness (the two words often being used interchangeably) of the medications and medical treatments offered by AMI and, subsequently, NRM. In circumstances where, as his Honour found at paragraphs [202]-[206] of the Reasons, AMI salespeople made statements to patients about the efficacy or effectiveness of the medications and medical services offered by AMI, one of the major issues at trial was the efficacy or effectiveness of the AMI treatments: see the Reasons at [218]-[220]. After a detailed discussion of the scientific evidence regarding apomorphine (being the medication used by AMI to treat ED), North J concluded at paragraph [249] that Dr Vaisman's view about apormorphine as a treatment for ED was not only inconsistent with the scientific material relied on by the respondents in written submissions, but was also inconsistent with the scientific material on the subject exhibited to his first witness statement. At paragraph [258] and following, North J considered the evidence relating to the "efficacy" of clomipramine as a treatment for PE, this being the medication offered by AMI. In paragraph [277], North J concluded that whilst clomipramine had a limited role in the treatment of PE, it was displaced when the ejaculation-delaying effects of other medication, referred to as SSRIs, were discovered. North J found that the value which the respondents sought to place on clomipramine as a treatment for PE was exaggerated, and SSRIs were the first-line treatment for primary PE: Reasons at [277].
68 North J then considered the "efficacy" of the drug delivery systems usually offered by AMI and NRM, namely nasal spray in the AMI period and oral strips in the NRM period: see the Reasons at [279] and following. After a detailed review of the evidence, North J accepted the evidence of Professor Colin Pouton that there is no scientific basis on which it can be concluded that the delivery of AMI and NRM medications through the nasal and buccal routes by nasal sprays, troches or oral strips is effective: Reasons at [327]. In paragraph [351], North J said:
Whatever the effectiveness of apomorphine taken sublingually on-demand in the treatment of ED, or the effectiveness of clomipramine taken daily by tablet for the treatment of PE, there is no evidence that these medications administered by nasal spray or oral strip in much smaller doses is effective in the treatment of those conditions. Any potential effect of using the nasal, oral, or buccal routes for these medications is speculative.
69 In my view, the Reasons, in particular the passages referred to above, support the position that the word "efficacy" bears its ordinary meaning when used in paragraph 9(c)(i) of the April 2015 orders.
70 I note that the part of the ACCC's case at trial that concerned advertising did not focus on statements about the "efficacy" of the AMI treatments and NRM treatments but rather on statements that the treatment for ED and PE was by consultation with doctors: see the Reasons at [72]. As summarised in paragraph [130] of the Reasons, there were two predominant themes in AMI advertising: one was that the treatment was by a nasal spray delivery technology; the other was that the treatment was provided by doctors. However, in my view the different focus of the advertising part of the ACCC's case at trial does not affect the construction of the word "efficacy" in paragraph 9(c)(i). It does not suggest an alternative meaning for the word in that paragraph. If there be an issue about whether the orders made are sufficiently related to the conduct found to have contravened the legislation, that is a matter for the appeal against the orders rather than a matter to be considered in the present application.
71 As noted above, NRM's primary submission in relation to the word "efficacy" was that it was not "clear and unambiguous", and therefore paragraph 9(c)(i) could not found a contempt proceeding. NRM submitted, in the alternative, that the word "efficacy" meant "ability to bring about the intended result", citing the New Shorter Oxford English Dictionary. This is essentially the same as the Macquarie Dictionary definition set out above. Thus, the construction which NRM contended for (in the alternative to its primary submission) was the ordinary meaning of the word "efficacy".
72 For these reasons, I conclude that the word "efficacy" as used in paragraph 9(c)(i) of the April 2015 orders is clear and unambiguous, and bears its ordinary meaning, which is satisfactorily encapsulated in the definition, "capacity for serving to produce effects; effectiveness".
73 The next issue to consider is whether each of the statements in issue was a statement (or representation) as to the "efficacy" of NRM treatments.
74 In relation to items 1, 2 and 3 of Schedule 1 to the Amended Statement of Charge, NRM conceded that, if the order is capable of having any effect at all, these statements breached the order. In my view, this concession was correctly made and should be accepted. In relation to item 1, the statement that NRM's products "put a stop to" premature ejaculation is a statement as to the efficacy of NRM treatments. In relation to item 2, the statement that NRM's products are "effective" is a statement as to the efficacy of NRM treatments. Item 3 contains the same words, relevantly, as item 1. Accordingly, I find that NRM breached paragraph 9(c)(i) of the orders by causing to be broadcast the radio advertisements identified in items 1, 2 and 3.
75 No similar concession was made by NRM regarding the other items.
76 Items 4, 5 and 6 comprise statements made in other radio advertisements. Item 4 includes the statement that NRM's products "will get you back to your room shaking, show stopping sex". In my view, this is a statement as to the efficacy of NRM treatments because it represents that they will be effective. The advertisement also includes the statement, "you'll be her longer, stronger lover again … and again". The implication of this statement is that the treatments will be effective. Hence this too is a statement as to the efficacy of NRM treatments.
77 Item 5 includes the statement that "AMI's revolutionary oral strips will get you back to your room shaking, show stropping special cuddles". This advertisement uses the words "special cuddles" rather than the word "sex" which was used in the comparable sentence in item 4. However, in the context of the advertisement as a whole, this distinction is not material. In my view, the statement is tantamount to saying that the NRM treatments will be effective in addressing premature ejaculation problems, and hence is a statement as to the efficacy of NRM treatments. Further, the statement, "you'll be her longer, stronger lover again", which also forms part of the advertisement, is in my view a statement as to the efficacy of NRM treatments, because it is implicitly saying that they are effective.
78 Item 6 also contains, in my view, a statement as to the efficacy of NRM treatments. After referring to the problem of premature ejaculation, the advertisement says that "one call can fix it all". The advertisement urges the listener to call the doctor at AMI about their revolutionary oral strips and then says: "Pop it on your tongue and bam you're her longer, stronger lover". In my view, this is implicitly stating that the products will be effective. The word "bam" is an interjection which is an imitation of the sound of a blow or an expression signifying a sudden occurrence (Macquarie Dictionary, 6th ed, 2013). The implication is that, upon taking the medication, the man's premature ejaculation problem will suddenly be resolved.
79 Items 7 to 19 of Schedule 1 to the Amended Statement of Charge are statements published by NRM on the Advanced Medical Institute website. For the following reasons, in my view most of these are statements as to the efficacy of the NRM treatments.
(a) Item 7 encourages the reader to call the doctors at AMI "to get immediate relief from Premature Ejaculation problem (sic)". This conveys that NRM treatments are effective.
(b) Item 8 includes the statement that "[p]roper and accurate medication is provided which helps our patients enjoy a healthy sex life". This conveys that NRM treatments are effective.
(c) Item 9 refers to the "New Oral strip treatment option" and describes it as a "new and revolutionary approach in the development of patient's (sic) friendly dosages of medication for the treatment of Erectile Dysfunction and Premature Ejaculation". I am not satisfied that these are statements (or representations) as to the efficacy of the treatments. The adjectives "new" and "revolutionary" do not clearly speak to the effectiveness of the treatments. Although there may be an implication that the treatments are effective, it is not sufficiently clear to conclude that this item amounts to a statement as to the efficacy of the treatments.
(d) Item 10 includes the statement that NRM's products "have path breaking results". This amounts to a statement that the products are effective, and is therefore a statement as to the efficacy of NRM treatments.
(e) Item 11 includes the statement that NRM's medications "have helped many patients experience healthy, enjoyable sex". This amounts to a statement that the medications are effective (at least in many cases) and is, therefore, a statement as to the efficacy of the NRM treatments.
(f) Item 12 includes the statement that there "is now an answer to put a stop" to premature ejaculation. It also states that AMI has become the "'go-to solution' for men and woman who have tried everything to enjoy a more fulfilling sex life". These statements convey that the treatments offered are effective and hence constitute statements as to the efficacy of NRM treatments.
(g) Item 13 contains a statement that at AMI "we have meds to treat Erectile dysfunction" and that treatment options are available. It also states that AMI is a "revolutionary thought leader in … treating Premature ejaculation and Erectile Dysfunction problems". I am not satisfied that these are statements (or representations) as to the efficacy of NRM treatments. Although there is a reference to having medications "to treat" erectile dysfunction, which may contain an implication as to efficacy, any such implication is not sufficiently clear.
(h) Item 14 is the same as item 12 and the same reasoning applies.
(i) Item 15 includes the statement that NRM's treatment "works with extreme ease in application and discreetness along with an improved onset of action". This is, in my view, a statement as to the efficacy of the treatment as the words "improved onset of action" convey that the treatment is effective.
(j) I am not satisfied that item 16 contains a statement (or representation) as to the efficacy of NRM treatments. Although there is a reference to "getting better at blokes (sic) business in bed", which may contain an implication as to efficacy, any such implication is not sufficiently clear.
(k) Item 17, comprises a video on the website (described in the item) together with certain statements. I have viewed the video file which formed part of the evidence. It is accurately described in item 17. In my view, the statements that "Medication acts twofold in Erectile Dysfunction" and "Medication treats Premature Ejaculation simultaneously", in conjunction with the video which shows the medication working, amount to statements that the medication is effective. Accordingly, in my view, this item constitutes a statement as to the efficacy of NRM treatments.
(l) Item 18, comprises various statements about premature ejaculation and erectile dysfunction, followed by: "Call AMI Specialist today to end PE Issues". In my view this is a statement as to the efficacy of NRM treatments because the implication is that the medication or medical services provided by NRM are effective to end PE issues.
(m) Item 19 also includes various statements about premature ejaculation and erectile dysfunction and then states: "At AMI we have meds to treat Erectile dysfunction. Treatment options are available for Erectile Dysfunction". I am not satisfied that this constitutes a statement (or representation) as to the efficacy of NRM treatments. It refers to the availability of treatment rather than making a statement about their effectiveness.
80 Item 20 is the television advertisement which has been described in paragraphs [45]-[47] above. The voiceover includes a statement that premature ejaculation problems "could be resolved" with AMI's treatment "for longer lasting sex". The voiceover also includes: "Call AMI doctors now for this incredible treatment that could help you resolve your premature ejaculation". In my view, these amount to statements that the treatments are effective, at least in some cases, and this constitutes a statement as to the efficacy of the treatments; it is a statement as to their capacity for serving to product effects or their effectiveness. The voiceover also includes: "Ask about this game changer and you could enjoy longer lasting sex". The same reasons apply to this statement. Further, the combination of the voiceover, the scenes, and the words on the screen reinforces the statements in the voiceover referred to above and confirms that they are statements as to the efficacy of the treatments.
81 In relation to the television advertisement, Schedule 1 to the Amended Statement of Charge specifies the period 23 April to 30 July 2015. However, the concession that NRM had knowledge of the terms of the orders is for the period "after 24 April 2015". In these circumstances, I consider that any finding of contempt should be limited to the period from 25 April 2015. (This issue does not apply to the other statements, as they were made after 24 April 2015.)
82 Where I have concluded that an item in Annexure "A" is a "statement" as to the efficacy of NRM treatments, for the same reasons it also constitutes a "representation" as to the efficacy of NRM treatments.
83 In relation to each of the statements which I have concluded are statements (and representations) as to the efficacy of NRM treatments, I consider this conclusion to be established beyond reasonable doubt. In the present case, as noted above, there is no issue concerning the fact that NRM caused to be broadcast the advertisements, and published or caused to be published the website statements. I am satisfied beyond reasonable doubt that each of the statements was made to a patient or prospective patient and (where I have so concluded) was a statement (and a representation) as to the efficacy of NRM treatments.
84 It follows from the above that NRM has breached paragraph 9(c)(i) of the April 2015 orders and is guilty of contempt of court by:
(a) causing to be broadcast the radio advertisements identified in items 1 to 6;
(b) publishing or causing to be published the statements on its website set out in items 7, 8, 10, 11, 12, 14, 15, 17 and 18; and
(c) causing to be broadcast, from 25 April 2015, the television advertisement identified in item 20.